US20100256696A1 - Anchoring Units For Implantable Electrical Stimulation Systems And Methods Of Making And Using - Google Patents
Anchoring Units For Implantable Electrical Stimulation Systems And Methods Of Making And Using Download PDFInfo
- Publication number
- US20100256696A1 US20100256696A1 US12/755,756 US75575610A US2010256696A1 US 20100256696 A1 US20100256696 A1 US 20100256696A1 US 75575610 A US75575610 A US 75575610A US 2010256696 A1 US2010256696 A1 US 2010256696A1
- Authority
- US
- United States
- Prior art keywords
- anchoring
- lead
- unit
- members
- anchoring unit
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0551—Spinal or peripheral nerve electrodes
- A61N1/0558—Anchoring or fixation means therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/056—Transvascular endocardial electrode systems
- A61N1/057—Anchoring means; Means for fixing the head inside the heart
Definitions
- the present invention is directed to the area of implantable electrical stimulation systems and methods of making and using the systems.
- the present invention is also directed to implantable electrical stimulation leads having one or more anchoring units coupled to the lead to facilitate fixing of the lead within patient tissue, as well as methods of making and using the leads, anchoring units, and electrical stimulation systems.
- Implantable electrical stimulation systems have proven therapeutic in a variety of diseases and disorders.
- spinal cord stimulation systems have been used as a therapeutic modality for the treatment of chronic pain syndromes.
- Deep brain stimulation has also been useful for treating refractory chronic pain syndromes and has been applied to treat movement disorders and epilepsy.
- Peripheral nerve stimulation has been used to treat chronic pain syndrome and incontinence, with a number of other applications under investigation.
- Functional electrical stimulation systems have been applied to restore some functionality to paralyzed extremities in spinal cord injury patients.
- electrical stimulation systems can be implanted subcutaneously to stimulate subcutaneous tissue including subcutaneous nerves such as the occipital nerve.
- a stimulator can include a control module (with a pulse generator), one or more leads, and an array of stimulator electrodes on each lead.
- the stimulator electrodes are in contact with or near the nerves, muscles, or other tissue to be stimulated.
- the pulse generator in the control module generates electrical pulses that are delivered by the electrodes to body tissue.
- an anchoring unit for an implantable lead includes a body, a plurality of anchoring members, and at least one connecting element coupling together at least two of the anchoring members that are positioned adjacent to one another.
- the body is configured and arranged for positioning along a portion of an outer surface of a lead.
- the body has a first end, a second end, and a longitudinal axis extending therebetween.
- the first end is configured and arranged for placement on the lead so that the first end is positioned more distally on the lead than the second end.
- Each anchoring member has a proximal end and a distal end. The proximal end of each anchoring member extends from the body and the distal end of each anchoring member anchors to patient tissue upon implantation of the anchoring unit into the patient.
- an anchoring unit for an implantable lead includes a body, at least one anchoring member, and at least one leaf spring.
- the body is configured and arranged for positioning along a portion of an outer surface of the lead.
- the at least one anchoring member has a proximal end and a distal end. The proximal end extends from the body and the distal end is configured and arranged for anchoring the anchoring unit to tissue of a patient upon implantation of the anchoring unit into the patient.
- the at least one leaf spring has a first end and a second end. The first end is coupled to the body and the second end is coupled to the distal end of the at least one anchoring member.
- an anchoring unit for an implantable lead includes a body and at least one anchoring member.
- the body is configured and arranged for positioning along a portion of an outer surface of a lead.
- the body has a first end and a second end and a longitudinal axis extending between the first end and the second end.
- the first end is configured and arranged for placement on the lead so that the first end is positioned more distally on the lead than the second end.
- the at least one anchoring member has a proximal end and a distal end.
- the proximal end extends from the body and the distal end is configured and arranged for anchoring the anchoring unit to tissue of a patient upon implantation into the patient.
- At least a portion of one anchoring member extends in a direction that forms an angle with the longitudinal axis of the body distal to the at least one anchoring member that is no greater than ninety degrees.
- an anchoring unit for an implantable lead includes a body and at least one anchoring member.
- the body is configured and arranged for positioning along a portion of an outer surface of the lead.
- the at least one anchoring member has a proximal end, a distal end, and a longitudinal axis.
- the proximal end of the at least one anchoring member extends from the body and the distal end of the at least one anchoring member is configured and arranged for anchoring the anchoring unit to tissue of a patient upon implantation into the patient.
- the at least one anchoring member extends from the body such that the at least one anchoring unit is arranged in a helical or spiral arrangement.
- an anchoring unit for an implantable lead includes a body and at least one anchoring member.
- the body is configured and arranged for positioning along a portion of an outer surface of the lead.
- the at least one anchoring member has a proximal end, a distal end, and a longitudinal axis.
- the proximal end of the at least one anchoring member extends from the body and the distal end of the at least one anchoring member is configured and arranged for anchoring the anchoring unit to tissue of a patient upon implantation into the patient.
- the distal end of the at least one anchoring member is wider than the proximal end of the at least one anchoring unit.
- an anchoring unit for an implantable lead in another embodiment, includes a body and a single anchoring member.
- the body is configured and arranged for positioning along a portion of an outer surface of the lead.
- the single anchoring member has a proximal end, a distal end, and a longitudinal axis.
- the proximal end of the single anchoring member extends from the body and the distal end of the single anchoring member is configured and arranged for anchoring the anchoring unit to tissue of a patient upon implantation into the patient.
- the single anchoring member extends from the body in a helical arrangement that extends at least one revolution around a circumference of the body.
- FIG. 1 is a schematic view of one embodiment of an electrical stimulation system, according to the invention.
- FIG. 2 is a schematic view of another embodiment of an electrical stimulation system, according to the invention.
- FIG. 3A is a schematic view of one embodiment of a proximal portion of a lead and a control module of an electrical stimulation system, according to the invention
- FIG. 3B is a schematic view of one embodiment of a proximal portion of a lead and a lead extension of an electrical stimulation system, according to the invention.
- FIG. 4A is a schematic perspective view of a first embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body and anchoring members with an arcing longitudinal axis, according to the invention;
- FIG. 4B is a schematic bottom view, side view, and top view of the anchoring unit shown in FIG. 4A , according to the invention.
- FIG. 5A is a schematic perspective view of a second embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body and anchoring members coupled to the body in a helical arrangement, according to the invention;
- FIG. 5B is a schematic bottom view, side view, and top view of the anchoring unit shown in FIG. 5A , according to the invention.
- FIG. 6A is a schematic perspective view of a third embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body defining at least one slit and anchoring members coupled to the body in a helical arrangement, according to the invention;
- FIG. 6B is a schematic bottom view, side view, and top view of the anchoring unit shown in FIG. 6A , according to the invention.
- FIG. 7A is a schematic perspective view of a fourth embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body, anchoring members coupled to the body, and connecting elements coupling distal ends of the anchoring members to one another, according to the invention;
- FIG. 7B is a schematic bottom view, side view, and top view of the anchoring unit shown in FIG. 7A , according to the invention.
- FIG. 8A is a schematic perspective view of a fifth and a sixth embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body and at least one anchoring member, according to the invention
- FIG. 8B is a schematic bottom view, side view, and top view of the anchoring unit shown in FIG. 8A , according to the invention.
- FIG. 9A is a schematic perspective view of a seventh embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body and anchoring members coupled to the body, the anchoring members increasing in width as the anchoring members extend away from the body, according to the invention;
- FIG. 9B is a schematic bottom view, side view, and top view of the anchoring unit shown in FIG. 9A , according to the invention.
- FIG. 10A is a schematic perspective view of an eighth embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body and anchoring members coupled to the body, each anchoring member having a distal end that also couples to the body via a leaf spring, according to the invention;
- FIG. 10B is a schematic bottom view, side view, and top view of the anchoring unit shown in FIG. 10A , according to the invention.
- FIG. 11A is a schematic perspective view of a ninth embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body and distally-biased anchoring members, according to the invention
- FIG. 11B is a schematic bottom view, side view, and top view of the anchoring unit shown in FIG. 11A , according to the invention.
- FIG. 12A is a schematic perspective view of a tenth embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body and curled anchoring members, each anchoring member curled to include a proximally-biased section and a distally-biased section, according to the invention;
- FIG. 12B is a schematic bottom view, side view, and top view of the anchoring unit shown in FIG. 12A , according to the invention.
- FIG. 13A is a schematic perspective view of an eleventh embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body and articulated anchoring members, each anchoring member including a proximally-biased section and a distally-biased section, according to the invention;
- FIG. 13B is a schematic bottom view, side view, and top view of the anchoring unit shown in FIG. 13A , according to the invention.
- FIG. 14 is a schematic perspective view of one embodiment of a portion of a lead body of an electrical stimulation system on which four similarly-shaped anchoring units are disposed, according to the invention.
- FIG. 15 is a schematic perspective view of one embodiment of a portion of a lead body of an electrical stimulation system on which nine differently-shaped anchoring units are disposed, according to the invention.
- FIG. 16 is a schematic overview of one embodiment of components of a stimulation system, including an electronic subassembly disposed within a control module, according to the invention.
- the present invention is directed to the area of implantable electrical stimulation systems and methods of making and using the systems.
- the present invention is also directed to implantable electrical stimulation leads having one or more anchoring units coupled to the lead to facilitate fixing of the lead within patient tissue, as well as methods of making and using the leads, anchoring units, and electrical stimulation systems.
- Suitable implantable electrical stimulation systems include, but are not limited to, an electrode lead (“lead”) with one or more electrodes disposed on a distal end of the lead and one or more terminals disposed on one or more proximal ends of the lead.
- Leads include, for example, percutaneous leads, paddle leads, and cuff leads.
- Examples of electrical stimulation systems with leads are found in, for example, U.S. Pat. Nos. 6,181,969; 6,516,227; 6,609,029; 6,609,032; and 6,741,892; and U.S. patent application Ser. Nos. 10/353,101, 10/503,281, 11/238,240; 11/319,291; 11/327,880; 11/375,638; 11/393,991; and 11/396,309, all of which are incorporated by reference.
- FIG. 1 illustrates schematically one embodiment of an electrical stimulation system 100 .
- the electrical stimulation system includes a control module (e.g., a stimulator or pulse generator) 102 , a paddle body 104 , and at least one lead body 106 coupling the control module 102 to the paddle body 104 .
- the paddle body 104 and the one or more lead bodies 106 form a lead.
- the paddle body 104 typically includes an array of electrodes 134 .
- the control module 102 typically includes an electronic subassembly 110 and an optional power source 120 disposed in a sealed housing 114 .
- the control module 102 typically includes a connector 144 ( FIGS. 2 and 3A , see also 322 and 350 of FIG.
- the electrical stimulation system can include more, fewer, or different components and can have a variety of different configurations including those configurations disclosed in the electrical stimulation system references cited herein.
- the electrodes 134 can be disposed in an array at or near the distal end of the lead body 106 forming a percutaneous lead, as illustrated in FIG. 2 .
- a percutaneous lead may be isodiametric along the length of the lead.
- one or more lead extensions 312 can be disposed between the one or more lead bodies 106 and the control module 102 to extend the distance between the one or more lead bodies 106 and the control module 102 of the embodiments shown in FIGS. 1 and 2 .
- the electrical stimulation system or components of the electrical stimulation system are typically implanted into the body of a patient.
- the electrical stimulation system can be used for a variety of applications including, but not limited to, brain stimulation, neural stimulation, spinal cord stimulation, muscle stimulation, and the like.
- the electrodes 134 can be formed using any conductive, biocompatible material. Examples of suitable materials include metals, alloys, conductive polymers, conductive carbon, and the like, as well as combinations thereof.
- the number of electrodes 134 in the array of electrodes 134 may vary. For example, there can be two, four, six, eight, ten, twelve, fourteen, sixteen, or more electrodes 134 . As will be recognized, other numbers of electrodes 134 may also be used.
- the electrodes of the paddle body 104 or one or more lead bodies 106 are typically disposed in, or separated by, a non-conductive, biocompatible material including, for example, silicone, polyurethane, polyetheretherketone (“PEEK”), epoxy, and the like or combinations thereof.
- the paddle body 104 and one or more lead bodies 106 may be formed in the desired shape by any process including, for example, molding (including injection molding), casting, and the like. Electrodes and connecting wires can be disposed onto or within a paddle body either prior to or subsequent to a molding or casting process.
- the non-conductive material typically extends from the distal end of the lead to the proximal end of each of the one or more lead bodies 106 .
- the non-conductive, biocompatible material of the paddle body 104 and the one or more lead bodies 106 may be the same or different.
- the paddle body 104 and the one or more lead bodies 106 may be a unitary structure or can be formed as two separate structures that are permanently or detachably coupled together.
- Terminals are typically disposed at the proximal end of the one or more lead bodies 106 for connection to corresponding conductive contacts (e.g., 314 in FIGS. 3A and 340 of FIG. 3B ) in connectors (e.g., 144 in FIGS. 1-3A and 322 and 350 of FIG. 3B ) disposed on, for example, the control module 102 (or to other devices, such as conductive contacts on a lead extension, an operating room cable, or an adaptor).
- Conductive wires (“conductors”) (not shown) extend from the terminals (e.g., 310 in FIGS. 3A and 336 of FIG.
- each terminal e.g., 310 in FIGS. 3A and 336 of FIG. 3B
- each terminal e.g., 310 in FIGS. 3A and 336 of FIG. 3B
- the conductive wires may be embedded in the non-conductive material of the lead or can be disposed in one or more lumens (not shown) extending along the lead. In some embodiments, there is an individual lumen for each conductive wire. In other embodiments, two or more conductive wires may extend through a lumen.
- the one or more lumens may be flushed continually, or on a regular basis, with saline, epidural fluid, or the like.
- the one or more lumens can be permanently or removably sealable at the distal end.
- leads are coupled to connectors disposed on control modules.
- a lead 308 is shown configured and arranged for insertion to the control module 102 .
- the connector 144 includes a connector housing 302 .
- the connector housing 302 defines at least one port 304 into which a proximal end 306 of a lead 308 with terminals 310 can be inserted, as shown by directional arrow 312 .
- the connector housing 302 also includes a plurality of conductive contacts 314 for each port 304 . When the lead 308 is inserted into the port 304 , the conductive contacts 314 can be aligned with the terminals 310 on the lead 308 to electrically couple the control module 102 to the electrodes ( 134 of FIG.
- a connector 322 is disposed on a lead extension 324 .
- the connector 322 is shown disposed at a distal end 326 of the lead extension 324 .
- the connector 322 includes a connector housing 328 .
- the connector housing 328 defines at least one port 330 into which a proximal end 332 of a lead 334 with terminals 336 can be inserted, as shown by directional arrow 338 .
- the connector housing 328 also includes a plurality of conductive contacts 340 .
- the conductive contacts 340 disposed in the connector housing 328 can be aligned with the terminals 336 on the lead 334 to electrically couple the lead extension 324 to the electrodes ( 134 of FIG. 1 ) disposed at a distal end (not shown) of the lead 334 .
- the proximal end of a lead extension is similarly configured and arranged as a proximal end of a lead.
- the lead extension 324 may include a plurality of conductive wires (not shown) that electrically couple the conductive contacts 340 to a proximal end 348 of the lead extension 324 that is opposite to the distal end 326 .
- the conductive wires disposed in the lead extension 324 can be electrically coupled to a plurality of terminals (not shown) disposed on the proximal end 348 of the lead extension 324 .
- the proximal end 348 of the lead extension 324 is configured and arranged for insertion into a connector disposed in another lead extension.
- the proximal end 348 of the lead extension 324 is configured and arranged for insertion into a connector disposed in a control module.
- a connector disposed in a control module As an example, in FIG. 3B the proximal end 348 of the lead extension 324 is inserted into a connector 350 disposed in a control module 352 .
- Electrode placement can be important for obtaining efficacious patient response to stimulation.
- a distal end of a lead may migrate from an intended treatment site over time due to patient movement.
- a loss of efficacy may occur and surgical re-implantation may become necessary to re-establish efficacy.
- anchoring units are described for use with implantable electrical stimulation systems.
- one or more anchoring units may be disposed along a longitudinal axis of the lead body (see e.g., FIGS. 13 and 14 ).
- One or more anchoring units may be positioned on the lead body distal to the electrodes, in-between two or more electrodes, proximal to the electrodes, or any combination thereof.
- the anchoring units may be different sizes and shapes.
- the anchoring units When multiple anchoring units are disposed on a lead body, the anchoring units may either be all of similar size and shape, or one or more of the anchoring units may have different sizes or shapes from other anchoring units disposed on the lead body. Furthermore, adjacent anchoring units disposed on the lead body may be evenly-spaced, or irregularly spaced from one another. In at least some embodiments, the shapes, sizes, or arrangements of anchoring units disposed on a lead body may be selected based, at least in part, on a specific indication or a specific anatomical location.
- the anchoring units may be formed from any suitable biocompatible material including, for example, polyurethane, silicone rubber, polytetrafluoroethylene, polyethylene, nylon, metal, nitinol, and the like or combinations thereof.
- at least a portion of the anchoring units are formed integrally with the lead body (e.g., by overmolding a body of an anchoring unit to the lead body, reflowing a body of an anchoring unit to the lead body, or the like).
- anchoring units may be coupled to the lead body at selected locations along a longitudinal axis of the lead using any suitable bonding process including, for example, chemical bonding, welding, interference fit, and the like or combinations thereof.
- FIG. 4A is a schematic perspective view of a first embodiment of an anchoring unit 402 for an electrical stimulation system.
- the anchoring unit 402 includes a body 404 and one or more anchoring members 406 .
- the body 404 includes a first end 408 and a second end 410 and is configured and arranged to be disposed over at least a portion of an outer surface of the lead body (see e.g., FIGS. 13 and 14 ).
- the first end 408 is positioned more distally than the second end 410 when the anchoring unit 402 is disposed on the lead body ( 106 in FIG. 1 ).
- the anchoring members 406 each include a proximal end 412 , a distal end 414 , and a longitudinal axis 415 defined by a first side 416 and a second side 418 .
- the anchoring members form a spiral arrangement.
- the first sides 416 of the anchoring members 406 are arcing leading edges and the second sides 418 are lagging edges, thereby forming an arcing longitudinal axis 415 .
- the lagging second sides 418 are also arcing.
- the first sides 416 of the anchoring members 406 are similarly-arced to form a spiral pattern.
- the first sides 416 of the anchoring members 406 are longer in length than the second sides 418 of the anchoring members 406 .
- the first side 416 and the second side 418 of the anchoring members 402 taper inward such that the proximal ends 412 are wider than the distal ends 414 .
- the distal end 414 of at least one of the anchoring members 406 tapers to form a point.
- the point is rounded. It may be an advantage to employ one or more anchoring units 402 with anchoring members 406 that taper to points because a medical practitioner may be able to rotate the lead to further engage the anchor members 406 within patient tissue during implantation, thereby increasing the anchoring ability of the lead.
- FIG. 4B is a schematic bottom view, side view, and top view of the anchoring unit 402 .
- the anchoring members 406 extend from the second end 410 of the body 404 along a common transverse axis of the body 404 .
- the anchoring members 406 are proximally biased. In other words, when the anchoring unit 402 is disposed on the lead body ( 106 in FIG. 1 ) so that the first end 408 is more distal on the lead body ( 106 in FIG. 1 ) than the second end 410 , the anchoring members 406 form an angle with the longitudinal axis of the body 404 that is at least ninety degrees, as shown by angle ⁇ 420 .
- FIG. 5A is a schematic perspective view of a second embodiment of an anchoring unit 502 .
- the anchoring unit 502 includes a body 504 and one anchoring member 506 .
- the body 504 includes a first end 508 and a second end 510 and the anchoring member 506 includes a proximal end 512 , a distal end 514 , a longitudinal axis 515 , a first side 516 , and a second side 518 .
- the proximal end 512 of the anchoring member 506 extends at least three-fourths of one complete revolution around a circumference of the body 504 . In at least some embodiments, the proximal end 512 of the anchoring member 506 extends at least one complete revolution around the circumference of the body 504 . In at least some embodiments, the proximal end 512 of the anchoring member 506 couples to the body 504 in a helical arrangement along a longitudinal axis of the body 504 such that the first side 516 and the second side 518 of the anchoring member 506 couple to the body 504 along different transverse points along the longitudinal axis of the body 504 .
- the pitch and the number of revolutions of the anchoring member 506 around a circumference of the body 504 may be tailored to the specific indication or the specific anatomical location of the implantation of the lead body ( 106 in FIG. 1 ) to which one or more of the anchoring units 502 may be coupled.
- the first side 516 and the second side 518 of the anchoring member 502 taper outward such that the distal end 514 is wider than the proximal end 512 . In at least some embodiments, the first side 516 and the second side 518 of the anchoring member 502 taper inward such that the proximal end 512 is wider than the distal end 514 . In at least some embodiments, the proximal end 512 and the distal end 514 are of approximately equal width.
- FIG. 5B is a schematic bottom view, side view, and top view of the anchoring unit 502 .
- the anchoring member 506 is proximally biased.
- the anchoring member 506 forms an angle with the longitudinal axis of the body 504 that is at least ninety degrees, as shown by angle ⁇ 520 .
- FIG. 6A is a schematic perspective view of a third embodiment of an anchoring unit 602 .
- the anchoring unit 602 includes a body 604 and at least one anchoring member 606 .
- the body 604 includes a first end 608 and a second end 610 .
- the anchoring member 606 includes a proximal end 612 , a distal end 614 , a longitudinal axis 615 , a first side 616 , and a second side 618 .
- the body 604 also defines one or more slits 620 along at least portion of the second end 610 of the body 604 between adjacent anchoring members 606 .
- the one or more slits 616 extend in a direction that is parallel to a longitudinal axis of the body 604 . In at least some embodiments, the one or more slits 616 facilitate the anchoring members 606 lying flat (e.g., during insertion of the lead into a patient).
- the first side 616 and the second side 618 of the anchoring member 602 taper outward such that the distal end 614 is wider than the proximal end 612 .
- the proximal ends 612 of two or more anchoring members 606 extend from the body 604 in a helical pattern along a longitudinal axis of the body 604 such that the first side 616 and the second side 618 of each of two or more the anchoring units 602 extend from the body 604 along different transverse axes of the body 604 .
- the pitch and the number of revolutions of the anchoring members 606 around a circumference of the body 604 may be tailored to the specific indication or the specific anatomical location of the implantation of the lead body ( 106 in FIG. 1 ) to which one or more of the anchoring units 602 may be coupled.
- FIG. 6B is a schematic bottom view, side view, and top view of the anchoring unit 602 .
- the anchoring members 606 are proximally biased.
- the anchoring members 606 form an angle with the longitudinal axis of the body 604 that is at least ninety degrees, as shown by angle ⁇ 622 .
- FIG. 7A is a schematic perspective view of a fourth embodiment of an anchoring unit 702 .
- the anchoring unit 702 includes a body 704 and at least one anchoring member 706 .
- the body 704 includes a first end 708 and a second end 710 .
- the anchoring unit 702 includes a body 704 and at least one anchoring member 706 .
- the body 704 includes a first end 708 and a second end 710 .
- the anchoring member 706 includes a proximal end 712 , a distal end 714 , a longitudinal axis 715 , a first side 716 , and a second side 718 .
- the first side 716 and the second side 718 of the anchoring member 706 taper such that the proximal end 712 of the anchoring member 706 is wider than the distal end 714 .
- the distal end 714 of at least one of the anchoring members 706 tapers to form a point. In a preferred embodiment, the point is rounded.
- two or more of the anchoring members 706 may be coupled to one another by a connecting element 720 .
- two adjacent anchoring members 706 may be coupled to one another by one or more connecting elements 720 .
- the distal end 714 of each anchoring member 706 is coupled to the distal end 714 of each adjacent anchoring member 706 by connecting elements 720 .
- a single connecting element 720 connects adjacent distal ends 714 to one another.
- a plurality of connecting elements 720 connect adjacent distal ends 714 to one another.
- a single connecting element 720 connects each of the adjacent distal ends 714 together.
- an open space 722 is formed between the connecting element 720 and adjacent anchoring members 706 .
- the one or more connecting elements 720 may couple adjacent anchoring members 706 at locations along the longitudinal axis of the anchoring members 706 other than the distal ends 714 .
- the connecting element may couple to a given anchoring member 706 at a position between the proximal end 712 and a distal end 714 of the anchoring member 706 .
- the connecting members 720 are formed with the anchoring unit 702 . In at least some other embodiments, the connecting members 720 are formed subsequently assembled.
- the connecting elements 702 are configured and arranged to fold flat against the lead body ( 106 in FIG. 1 ).
- the connecting elements 720 are configured and arranged to fold into open spaces between the anchoring members 706 when the anchoring members 706 are folded against the lead body ( 106 in FIG. 1 ).
- at least one of the connecting elements 702 includes at least one bend to facilitate folding flat.
- at least one of the connecting elements 702 is articulated to facilitate folding flat.
- the connecting elements 720 increase the anchoring ability of the anchoring unit 702 by further facilitating tissue ingrowth.
- FIG. 7B is a schematic bottom view, side view, and top view of the anchoring unit 702 .
- the anchoring members 706 extend from the second end 710 of the body 704 along a common transverse axis of the body 704 .
- the anchoring members 706 are proximally biased. In other words, when the anchoring unit 702 is disposed on the lead body ( 106 in FIG. 1 ) so that the first end 708 is more distal on the lead body ( 106 in FIG. 1 ) than the second end 710 , the anchoring members 706 form an angle with the longitudinal axis of the body 704 that is at least ninety degrees, as shown by angle ⁇ 724 .
- FIG. 8A is a schematic perspective view of a fifth embodiment of an anchoring unit 802 .
- the anchoring unit 802 includes a body 804 and at least one anchoring member 806 .
- the body 804 includes a first end 808 and a second end 810 .
- the anchoring unit 802 includes a body 804 and at least one anchoring member 806 .
- the body 804 includes a first end 808 and a second end 810 .
- the anchoring member 806 includes a proximal end 812 , a distal end 814 , a longitudinal axis 815 , a first side 816 , and a second side 818 .
- the first side 816 and the second side 818 of the anchoring member 806 taper such that the proximal end 812 of the anchoring member 806 is wider than the distal end 814 .
- the distal end 814 of at least one of the anchoring members 806 tapers to form a point. In a preferred embodiment, the point is rounded.
- the first side 816 and the second side 818 of the anchoring member 806 taper such that the distal end 814 of the anchoring member 806 is wider than the proximal end 812 .
- the first side 816 and the second side 818 of the anchoring member 806 are of approximately equal width.
- two or more of the anchoring members 806 may be coupled to one another by a connecting element 820 .
- the connecting element 820 comprises a membrane, or sheath, that couples two or more of the anchoring members 806 to one another.
- the connective element 820 has a thickness that is substantially thinner than the anchoring members 806 .
- the connecting element 820 forms a complete revolution around the body 804 .
- the connective element 820 covers at least a portion of at least one of the anchoring members 806 .
- the connecting element 820 substantially entirely covers each of the anchoring members 806 .
- the connecting element 820 completely covers each of the anchoring members 806 . In at least some embodiments, at least a portion of at least one of the anchoring members 806 may need to deform onto itself while in a folded position (e.g., during insertion of the lead into a patient).
- FIG. 8B is a schematic bottom view, side view, and top view of the anchoring unit 802 .
- the anchoring members 806 extend from the second end 810 of the body 804 along a common transverse axis of the body 804 .
- the anchoring members 806 are proximally biased. In other words, when the anchoring unit 802 is disposed on the lead body ( 106 in FIG. 1 ) so that the first end 808 is more distal on the lead body ( 106 in FIG. 1 ) than the second end 810 , the anchoring members 806 form an angle with the longitudinal axis of the body 804 that is at least ninety degrees, as shown by angle ⁇ 822 .
- the anchoring unit 802 includes a single anchoring member 806 that extends around the entire circumference of the body 804 .
- the anchoring member 806 is a constant thickness. In at least some other embodiments, the thickness of the anchoring member 806 may vary. In at least some embodiments, the anchoring member 806 may define one or more cutouts for promoting tissue ingrowth.
- FIG. 9A is a schematic perspective view of a seventh embodiment of an anchoring unit 902 .
- the anchoring unit 902 includes a body 904 and at least one anchoring member 906 .
- the body 904 includes a first end 908 and a second end 910 .
- the anchoring unit 902 includes a body 904 and at least one anchoring member 906 .
- the body 904 includes a first end 908 and a second end 910 .
- the anchoring member 906 includes a proximal end 912 , a distal end 914 , a longitudinal axis 915 , a first side 916 , and a second side 918 .
- the first side 916 and the second side 918 of the anchoring members 906 taper outward such that the distal end 914 is wider than the proximal end 912 .
- the anchoring members 906 extend from the second end 910 of the body 904 along a common transverse axis of the body 904 .
- two anchoring members 906 are disposed on opposing portions of the body 904 such that the two anchoring members 906 extend in opposite directions from the body 904 .
- the sum of the arc lengths of the distal ends 914 of the anchoring members 906 are no greater than the circumference of the body 904 .
- the widest portions of the anchoring members 906 have lengths that are at least as long as the diameter of the body 904 .
- FIG. 9B is a schematic bottom view, side view, and top view of the anchoring unit 902 .
- the anchoring members 906 are proximally biased.
- the anchoring members 906 form an angle with the longitudinal axis of the body 904 that is at least ninety degrees, as shown by angle ⁇ 920 .
- FIG. 10A is a schematic perspective view of an eighth embodiment of an anchoring unit 1002 .
- the anchoring unit 1002 includes a body 1004 and at least one anchoring member 1006 .
- the body 1004 includes a first end 1008 and a second end 1010 .
- the anchoring unit 1002 includes a body 1004 and at least one anchoring member 1006 .
- the body 1004 includes a first end 1008 and a second end 1010 .
- the anchoring member 1006 includes a proximal end 1012 , a distal end 1014 , a longitudinal axis 1015 , a first side 1016 , and a second side 1018 .
- the first side 1016 and the second side 1018 of the anchoring member 1006 taper such that the proximal end 1012 of the anchoring member 1006 is wider than the distal end 1014 .
- the distal end 1014 of at least one of the anchoring members 1006 tapers to form a point. In a preferred embodiment, the point is rounded.
- the first side 1016 and the second side 1018 of the anchoring member 1006 taper such that the distal end 1014 of the anchoring member 1006 is wider than the proximal end 1012 .
- the first side 1016 and the second side 1018 of the anchoring member 1006 are of approximately equal width.
- the anchoring unit 1002 further includes at least one secondary connecting member 1020 coupling the body 1004 to the distal end 1014 of one of the anchoring members 1006 .
- the at least one secondary connecting member 1020 is a leaf spring.
- the secondary connecting member 1020 forms a solid surface between the body 1004 and the anchoring member 1006 .
- the secondary connecting member 1020 forms at least one cutout 1022 between the body 1004 , anchoring member 1006 , and the secondary connecting member 1020 . It may be a particular advantage of the anchoring unit 1002 that tissue ingrowth may occur in the cutouts 1022 to at least partially fill the cutouts 1022 with tissue to further increase the anchoring ability of the anchoring unit 1002 .
- the secondary connecting member 1020 stretches, thereby storing potential energy.
- the stored potential energy may facilitate anchoring of the anchoring member 1006 within patient tissue when the anchoring unit 1002 is released from the insertion needle and the stored potential energy is released.
- FIG. 10B is a schematic bottom view, side view, and top view of the anchoring unit 1002 .
- the anchoring members 1006 extend from the second end 1010 of the body 1004 along a common transverse axis of the body 1004 .
- the anchoring members 1006 are proximally biased. In other words, when the anchoring unit 1002 is disposed on the lead body ( 106 in FIG. 1 ) so that the first end 1008 is more distal on the lead body ( 106 in FIG. 1 ) than the second end 1010 , the anchoring members 1006 form an angle with the longitudinal axis of the body 1004 that is at least ninety degrees, as shown by angle ⁇ 1024 .
- FIG. 11A is a schematic perspective view of a ninth embodiment of an anchoring unit 1102 .
- the anchoring unit 1102 includes a body 1104 and at least one anchoring member 1106 .
- the body 1104 includes a first end 1108 and a second end 1110 .
- the anchoring unit 1102 includes a body 1104 and at least one anchoring member 1106 .
- the body 1104 includes a first end 1108 and a second end 1110 .
- the anchoring member 1106 includes a proximal end 1112 , a distal end 1114 , a longitudinal axis 1115 , a first side 1116 , and a second side 1118 .
- the first side 1116 and the second side 1118 of the anchoring member 1106 taper such that the proximal end 1112 of the anchoring member 1106 is wider than the distal end 1114 .
- the distal end 1114 of at least one of the anchoring members 1106 tapers to form a rounded point.
- the first side 1116 and the second side 1118 of the anchoring member 1106 taper such that the distal end 1114 of the anchoring member 1106 is wider than the proximal end 1112 .
- the first side 1116 and the second side 1118 of the anchoring member 1106 are of approximately equal width.
- the anchoring members 1106 when the anchoring unit 1102 is separated from an insertion needle during insertion of the lead, the anchoring members 1106 are configured and arranged to extend within patient tissue. In some instances, the anchoring members 1106 are able to extend to distally-biased positions and in other instances they are not, depending on, for example, the amount of open space around the anchoring unit 1102 and the hardness of the surrounding tissue. For example, anchoring members 1106 may not be able to extend to distally-biased positions when positioned in a narrow space between hard tissues, such as bones or cartilage. When the anchoring members 1106 do extend to distally-biased positions, the anchoring members 1106 may resist withdrawal of the lead to which the anchoring unit 1102 is coupled.
- the anchoring members 1106 fix the anchoring unit 1102 in position by the force of the anchoring members 1106 pressing against tissue in a manner similar to the proximally-biased anchoring members, discussed above. It may be an advantage of distally-biased anchoring members 1106 that, should an explant be necessary for the lead to which the anchoring unit 1102 is coupled, distally-biased anchoring members may be easier to remove from patient tissue than similarly-sized proximally-biased anchoring members.
- FIG. 11B is a schematic bottom view, side view, and top view of the anchoring unit 1102 .
- the anchoring members 1106 extend from the second end 1110 of the body 1104 along a common transverse axis of the body 1104 .
- the anchoring members 1106 are distally biased. In other words, when the anchoring unit 1102 is disposed on the lead body ( 106 in FIG. 1 ) so that the first end 1108 is more distal on the lead body ( 106 in FIG. 1 ) than the second end 1110 , the anchoring members 1106 form an angle with the longitudinal axis of the body 1104 that is no more than ninety degrees, as shown by angle ⁇ 1120 .
- FIG. 12A is a schematic perspective view of a tenth embodiment of an anchoring unit 1202 .
- the anchoring unit 1202 includes a body 1204 and at least one anchoring member 1206 .
- the body 1204 includes a first end 1208 and a second end 1210 .
- the anchoring unit 1202 includes a body 1204 and at least one anchoring member 1206 .
- the body 1204 includes a first end 1208 and a second end 1210 .
- the anchoring member 1206 includes a proximal end 1212 , a distal end 1214 , a curled longitudinal axis 1215 , a first side 1216 , and a second side 1218 .
- the anchoring members 1206 have an arc-shaped transverse profile.
- the first side 1216 and the second side 1218 of the anchoring member 1206 taper such that the proximal end 1212 of the anchoring member 1206 is wider than the distal end 1214 .
- the distal end 1214 of at least one of the anchoring members 1206 tapers to form a rounded point.
- the first side 1216 and the second side 1218 of the anchoring member 1206 taper such that the distal end 1214 of the anchoring member 1206 is wider than the proximal end 1212 .
- the first side 1216 and the second side 1218 of the anchoring member 1206 are of approximately equal width.
- the anchoring members 1206 are configured and arranged to lie flat during insertion of the lead and curl upon separation from an insertion needle. In at least some embodiments, the anchoring members 1206 have an arc-shaped transverse profile that facilitates the anchoring members 1206 lying flat against the lead. In at least some embodiments, when the anchoring unit 1202 is separated from an insertion needle during insertion of the lead, the anchoring members 1206 are configured and arranged to curl up such that the anchoring members 1206 extend within patient tissue.
- the anchoring members may include a metal, such as nitinol, or a polymer that is configured and arranged to curl when unconstrained.
- the anchoring members 1206 are able to extend to distally-biased positions and in other instances they are not, depending on, for example, the amount of open space around the anchoring unit 1202 and the hardness of the surrounding tissue.
- anchoring members 1206 may not be able to extend to distally-biased positions when positioned in a narrow space between hard tissues, such as bones or cartilage.
- the anchoring members 1206 may resist withdrawal of the lead to which the anchoring unit 1202 is coupled.
- the anchoring members 1206 fix the anchoring unit 1202 in position by the force of the anchoring members 1206 pressing against tissue in a manner similar to the proximally-biased anchoring members, discussed above.
- FIG. 12B is a schematic bottom view, side view, and top view of the anchoring unit 1202 .
- the anchoring members 1206 extend from the second end 1210 of the body 1204 along a common transverse axis of the body 1104 .
- at least one of the anchoring members 1206 is configured and arranged to curl up such that a portion of that anchoring member is proximally biased and a portion of that anchoring member is distally biased.
- the one or more anchoring members extend from the body at the second end of the body, which, as discussed above, is the end of the body that is positioned more proximally than the first end when the anchoring unit is disposed on the lead body ( 106 in FIG. 1 ).
- the one or more anchoring members are articulated.
- FIG. 13A is a schematic perspective view of an eleventh embodiment of an anchoring unit 1302 .
- the anchoring unit 1302 includes a body 1304 and at least one anchoring member 1306 .
- the body 1304 includes a first end 1308 and a second end 1310 .
- the anchoring unit 1302 includes a body 1304 and at least one anchoring member 1306 .
- the body 1304 includes a first end 1308 and a second end 1310 .
- the anchoring member 1306 includes a proximal end 1312 , a distal end 1314 , a longitudinal axis 1315 , a first side 1316 , and a second side 1318 .
- At least one of the anchoring members 1306 includes at least one articulation 1320 dividing the anchoring member 1306 into a plurality of sections.
- the articulation 1320 divides the anchoring member 1306 into a proximal section 1322 and a distal section 1324 .
- the proximal section 1322 includes at least one cutout 1326 . It may be a particular advantage of the anchoring unit 1302 that tissue may at least partially fill the cutouts 1326 defined in the proximal section 1322 of the anchoring member 1306 to further increase the anchoring ability of the anchoring unit 1302 .
- the distal sections 1324 of the anchoring members 1306 are configured and arranged to fold into the cutouts 1326 defined in the proximal sections 1322 of the anchoring members 1306 (e.g., during insertion of the lead).
- the proximal section 1322 of at least one of the anchoring members 1306 is wider than the distal section 1324 of the anchoring member 1306 .
- the distal end 1314 of at least one of the anchoring members 1306 tapers to form a point. In a preferred embodiment, the point is rounded.
- the proximal section 1314 of at least one of the anchoring members 1306 is narrower than the distal section 1316 of the anchoring member 1306 .
- the proximal section 1314 of at least one of the anchoring members 1306 is of approximately equal width to the distal section 1316 of the anchoring member 1306 .
- FIG. 13B is a schematic bottom view, side view, and top view of the anchoring unit 1302 .
- the proximal sections 1322 of the anchoring members 1306 are proximally biased and the distal sections 1324 of the anchoring members 1306 are distally biased.
- the anchoring unit 1302 is disposed on the lead body ( 106 in FIG. 1 ) so that the first end 1308 is more distal on the lead body ( 106 in FIG.
- the proximal sections 1314 of the anchoring members 1306 form an angle with the longitudinal axis of the body 1304 that are greater than ninety degrees, as shown by angle ⁇ 1 1328 and the distal sections 1324 of the anchoring members 1306 form an angle with the longitudinal axis of the body 1304 that are no greater than ninety degrees, as shown by angle ⁇ 2 1330 .
- the body is substantially tubular-shaped with a diameter and a longitudinal axis that is perpendicular to a transverse axis of the body.
- the diameter of the body of the anchoring unit is approximately equal to the diameter of the lead body ( 106 in FIG. 1 ).
- the longitudinal axis of at least one of the anchoring member is at least half the length of the diameter of the body.
- the longitudinal axis of at least one of the anchoring members is no less than the length of the diameter of the body.
- the body is cuff-shaped.
- the anchoring members extend from the second end of the body (except for anchoring member 1306 ). In at least some embodiments, the anchoring members are proximally biased (except for anchoring members 1106 , 1206 , and 1306 ).
- the longitudinal axis of the anchoring members extend to a distal end.
- the anchoring members may have a distal end that is of approximately equal width as the proximal end (except for anchoring members 406 , 606 , 806 , 906 , and 1306 ).
- the distal end may be narrower than the proximal end (except for anchoring members 606 , 806 , and 906 ).
- the distal end may be wider than the proximal end (except for anchoring members 406 , 806 , and 1306 ).
- At least one of the anchoring members is formed integrally with the body. In at least some embodiments, at least one of the anchoring units is formed separately from the body and is coupleable to the body. In at least some embodiments, the anchoring members may include one or more features (e.g., barbs, ridges, fissures, knobs, grooves, and the like) coupled to, or formed with, the anchoring members for facilitating the anchoring ability of the anchoring unit when the anchoring unit is implanted in a patient.
- the anchoring members may include one or more features (e.g., barbs, ridges, fissures, knobs, grooves, and the like) coupled to, or formed with, the anchoring members for facilitating the anchoring ability of the anchoring unit when the anchoring unit is implanted in a patient.
- anchoring members may be coupled to, or formed with, the body including, for example, one, two, three, four, five, six, seven, eight, nine, ten or more anchoring members. As will be recognized, other numbers of anchoring members may also be coupled to, or formed with, the body.
- the anchoring unit may induce the formation of tissue ingrowth around at least a portion of the anchoring unit within the usable lifespan of the anchoring unit.
- the usable lifespan may vary depending on the indication and location of the lead to which the anchoring unit is coupled while implanted in a patient. It may be an advantage to have tissue ingrowth around at least a portion of the anchoring unit because the tissue ingrowth may further increase the anchoring ability of the anchoring unit when the anchoring unit is implanted in a patient. In the embodiments shown in FIGS. 6A-7B and 10 A- 10 B, additional tissue ingrowth may occur between open spaces between components of the anchoring unit (e.g., slits 620 , open space 722 , and cutout 1022 ).
- the anchoring members are flexible.
- the anchoring members when the anchoring unit is coupled to a lead body ( 106 in FIG. 1 ), the anchoring members are configured and arranged to fold flat against the lead body ( 106 in FIG. 1 ) during insertion of the lead.
- the anchoring members when, in at least some embodiments, a lead is inserted into a conventionally-sized insertion needle during implantation of the lead, the anchoring members fold against the lead body ( 106 in FIG. 1 ) without interfering with one another so that the lead is able to fit into a cannula of the conventionally-sized insertion needle.
- at least one of the anchoring members is contoured to facilitate the folding of the anchoring members. In the embodiments shown in FIGS. 8A-8B , at least a portion of at least one of the anchoring members 806 may need to deform onto itself while in a folded position.
- one or more anchoring units may be disposed on the lead body ( 106 of FIG. 1 ). In at least some embodiments, multiple anchoring units may be employed which have similarly-shaped anchoring members.
- FIG. 14 is a schematic perspective view of one embodiment of four anchoring units 1402 disposed on a portion of a lead body 1404 . In at least some embodiments, the anchoring units 1402 are evenly-spaced from one another. In at least some embodiments, at least some of the anchoring units 1402 are irregularly spaced from one another. In at least some embodiments, at least one of the anchoring units 1402 may be of a different size from the remaining anchoring units 1402 .
- the anchoring members of different anchoring units are aligned with respect to one another along the longitudinal axis of the lead body. In at least some other embodiments, the anchoring members of different anchoring units are staggered, unaligned, or randomly positioned with respect to other anchoring members along the lead body.
- FIG. 15 is a schematic side view of one embodiment of nine different anchoring units 402 , 502 , 602 , 702 , 802 , 902 , 1002 , 1102 , and 1302 disposed on a portion of the lead body 1502 .
- the anchoring units 402 , 502 , 602 , 702 , 802 , 902 , 1002 , 1102 , and 1302 are evenly-spaced from one another.
- At least some of the anchoring units 402 , 502 , 602 , 702 , 802 , 902 , 1002 , 1102 , and 1302 are irregularly spaced from one another. In at least some embodiments, at least one of the anchoring units 402 , 502 , 602 , 702 , 802 , 902 , 1002 , 1102 , and 1302 may be of a different size from the remaining anchoring units 402 , 502 , 602 , 702 , 802 , 902 , 1002 , 1102 , and 1302 .
- FIG. 16 is a schematic overview of one embodiment of components of an electrical stimulation system 1600 including an electronic subassembly 1610 disposed within a control module. It will be understood that the electrical stimulation system can include more, fewer, or different components and can have a variety of different configurations including those configurations disclosed in the stimulator references cited herein.
- power source 1612 can be used including, for example, a battery such as a primary battery or a rechargeable battery.
- a battery such as a primary battery or a rechargeable battery.
- other power sources include super capacitors, nuclear or atomic batteries, mechanical resonators, infrared collectors, thermally-powered energy sources, flexural powered energy sources, bioenergy power sources, fuel cells, bioelectric cells, osmotic pressure pumps, and the like including the power sources described in U.S. Patent Application Publication No. 2004/0059392, incorporated herein by reference.
- power can be supplied by an external power source through inductive coupling via the optional antenna 1618 or a secondary antenna.
- the external power source can be in a device that is mounted on the skin of the user or in a unit that is provided near the user on a permanent or periodic basis.
- the battery may be recharged using the optional antenna 1618 , if desired. Power can be provided to the battery for recharging by inductively coupling the battery through the antenna to a recharging unit 1616 external to the user. Examples of such arrangements can be found in the references identified above.
- electrical current is emitted by the electrodes 134 on the paddle or lead body to stimulate nerve fibers, muscle fibers, or other body tissues near the electrical stimulation system.
- a processor 1604 is generally included to control the timing and electrical characteristics of the electrical stimulation system. For example, the processor 1604 can, if desired, control one or more of the timing, frequency, strength, duration, and waveform of the pulses. In addition, the processor 1604 can select which electrodes can be used to provide stimulation, if desired. In some embodiments, the processor 1604 may select which electrode(s) are cathodes and which electrode(s) are anodes. In some embodiments, the processor 1604 may be used to identify which electrodes provide the most useful stimulation of the desired tissue.
- Any processor can be used and can be as simple as an electronic device that, for example, produces pulses at a regular interval or the processor can be capable of receiving and interpreting instructions from an external programming unit 1608 that, for example, allows modification of pulse characteristics.
- the processor 1604 is coupled to a receiver 1602 which, in turn, is coupled to the optional antenna 1618 . This allows the processor 1604 to receive instructions from an external source to, for example, direct the pulse characteristics and the selection of electrodes, if desired.
- the antenna 1618 is capable of receiving signals (e.g., RF signals) from an external telemetry unit 1606 which is programmed by a programming unit 1608 .
- the programming unit 1608 can be external to, or part of, the telemetry unit 1606 .
- the telemetry unit 1606 can be a device that is worn on the skin of the user or can be carried by the user and can have a form similar to a pager, cellular phone, or remote control, if desired.
- the telemetry unit 1606 may not be worn or carried by the user but may only be available at a home station or at a clinician's office.
- the programming unit 1608 can be any unit that can provide information to the telemetry unit 1606 for transmission to the electrical stimulation system 1600 .
- the programming unit 1608 can be part of the telemetry unit 1606 or can provide signals or information to the telemetry unit 1606 via a wireless or wired connection.
- One example of a suitable programming unit is a computer operated by the user or clinician to send signals to the telemetry unit 1606 .
- the signals sent to the processor 1604 via the antenna 1618 and receiver 1602 can be used to modify or otherwise direct the operation of the electrical stimulation system.
- the signals may be used to modify the pulses of the electrical stimulation system such as modifying one or more of pulse duration, pulse frequency, pulse waveform, and pulse strength.
- the signals may also direct the electrical stimulation system 1600 to cease operation, to start operation, to start charging the battery, or to stop charging the battery.
- the stimulation system does not include an antenna 1618 or receiver 1602 and the processor 1604 operates as programmed.
- the electrical stimulation system 1600 may include a transmitter (not shown) coupled to the processor 1604 and the antenna 1618 for transmitting signals back to the telemetry unit 1606 or another unit capable of receiving the signals.
- the electrical stimulation system 1600 may transmit signals indicating whether the electrical stimulation system 1600 is operating properly or not or indicating when the battery needs to be charged or the level of charge remaining in the battery.
- the processor 1604 may also be capable of transmitting information about the pulse characteristics so that a user or clinician can determine or verify the characteristics.
Abstract
An anchoring unit for an implantable lead includes a body, a plurality of anchoring members, and at least one connecting element coupling together at least two of the anchoring members that are positioned adjacent to one another. The body is configured and arranged for positioning along a portion of an outer surface of a lead. The body has a first end, a second end, and a longitudinal axis extending therebetween. The first end is configured and arranged for placement on the lead so that the first end is positioned more distally on the lead than the second end. Each anchoring member has a proximal end and a distal end. The proximal end of each anchoring member extends from the body and the distal end of each anchoring member anchors to patient tissue upon implantation of the anchoring unit into the patient.
Description
- This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application Ser. No. 61/167,358 filed on Apr. 7, 2009, which is incorporated herein by reference.
- The present invention is directed to the area of implantable electrical stimulation systems and methods of making and using the systems. The present invention is also directed to implantable electrical stimulation leads having one or more anchoring units coupled to the lead to facilitate fixing of the lead within patient tissue, as well as methods of making and using the leads, anchoring units, and electrical stimulation systems.
- Implantable electrical stimulation systems have proven therapeutic in a variety of diseases and disorders. For example, spinal cord stimulation systems have been used as a therapeutic modality for the treatment of chronic pain syndromes. Deep brain stimulation has also been useful for treating refractory chronic pain syndromes and has been applied to treat movement disorders and epilepsy. Peripheral nerve stimulation has been used to treat chronic pain syndrome and incontinence, with a number of other applications under investigation. Functional electrical stimulation systems have been applied to restore some functionality to paralyzed extremities in spinal cord injury patients. Moreover, electrical stimulation systems can be implanted subcutaneously to stimulate subcutaneous tissue including subcutaneous nerves such as the occipital nerve.
- Stimulators have been developed to provide therapy for a variety of treatments. A stimulator can include a control module (with a pulse generator), one or more leads, and an array of stimulator electrodes on each lead. The stimulator electrodes are in contact with or near the nerves, muscles, or other tissue to be stimulated. The pulse generator in the control module generates electrical pulses that are delivered by the electrodes to body tissue.
- In at least one embodiment, an anchoring unit for an implantable lead includes a body, a plurality of anchoring members, and at least one connecting element coupling together at least two of the anchoring members that are positioned adjacent to one another. The body is configured and arranged for positioning along a portion of an outer surface of a lead. The body has a first end, a second end, and a longitudinal axis extending therebetween. The first end is configured and arranged for placement on the lead so that the first end is positioned more distally on the lead than the second end. Each anchoring member has a proximal end and a distal end. The proximal end of each anchoring member extends from the body and the distal end of each anchoring member anchors to patient tissue upon implantation of the anchoring unit into the patient.
- In another embodiment, an anchoring unit for an implantable lead includes a body, at least one anchoring member, and at least one leaf spring. The body is configured and arranged for positioning along a portion of an outer surface of the lead. The at least one anchoring member has a proximal end and a distal end. The proximal end extends from the body and the distal end is configured and arranged for anchoring the anchoring unit to tissue of a patient upon implantation of the anchoring unit into the patient. The at least one leaf spring has a first end and a second end. The first end is coupled to the body and the second end is coupled to the distal end of the at least one anchoring member.
- In yet another embodiment, an anchoring unit for an implantable lead includes a body and at least one anchoring member. The body is configured and arranged for positioning along a portion of an outer surface of a lead. The body has a first end and a second end and a longitudinal axis extending between the first end and the second end. The first end is configured and arranged for placement on the lead so that the first end is positioned more distally on the lead than the second end. The at least one anchoring member has a proximal end and a distal end. The proximal end extends from the body and the distal end is configured and arranged for anchoring the anchoring unit to tissue of a patient upon implantation into the patient. At least a portion of one anchoring member extends in a direction that forms an angle with the longitudinal axis of the body distal to the at least one anchoring member that is no greater than ninety degrees.
- In another embodiment, an anchoring unit for an implantable lead includes a body and at least one anchoring member. The body is configured and arranged for positioning along a portion of an outer surface of the lead. The at least one anchoring member has a proximal end, a distal end, and a longitudinal axis. The proximal end of the at least one anchoring member extends from the body and the distal end of the at least one anchoring member is configured and arranged for anchoring the anchoring unit to tissue of a patient upon implantation into the patient. The at least one anchoring member extends from the body such that the at least one anchoring unit is arranged in a helical or spiral arrangement.
- In yet another embodiment, an anchoring unit for an implantable lead includes a body and at least one anchoring member. The body is configured and arranged for positioning along a portion of an outer surface of the lead. The at least one anchoring member has a proximal end, a distal end, and a longitudinal axis. The proximal end of the at least one anchoring member extends from the body and the distal end of the at least one anchoring member is configured and arranged for anchoring the anchoring unit to tissue of a patient upon implantation into the patient. The distal end of the at least one anchoring member is wider than the proximal end of the at least one anchoring unit.
- In another embodiment, an anchoring unit for an implantable lead includes a body and a single anchoring member. The body is configured and arranged for positioning along a portion of an outer surface of the lead. The single anchoring member has a proximal end, a distal end, and a longitudinal axis. The proximal end of the single anchoring member extends from the body and the distal end of the single anchoring member is configured and arranged for anchoring the anchoring unit to tissue of a patient upon implantation into the patient. The single anchoring member extends from the body in a helical arrangement that extends at least one revolution around a circumference of the body.
- Non-limiting and non-exhaustive embodiments of the present invention are described with reference to the following drawings. In the drawings, like reference numerals refer to like parts throughout the various figures unless otherwise specified.
- For a better understanding of the present invention, reference will be made to the following Detailed Description, which is to be read in association with the accompanying drawings, wherein:
-
FIG. 1 is a schematic view of one embodiment of an electrical stimulation system, according to the invention; -
FIG. 2 is a schematic view of another embodiment of an electrical stimulation system, according to the invention; -
FIG. 3A is a schematic view of one embodiment of a proximal portion of a lead and a control module of an electrical stimulation system, according to the invention; -
FIG. 3B is a schematic view of one embodiment of a proximal portion of a lead and a lead extension of an electrical stimulation system, according to the invention; -
FIG. 4A is a schematic perspective view of a first embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body and anchoring members with an arcing longitudinal axis, according to the invention; -
FIG. 4B is a schematic bottom view, side view, and top view of the anchoring unit shown inFIG. 4A , according to the invention; -
FIG. 5A is a schematic perspective view of a second embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body and anchoring members coupled to the body in a helical arrangement, according to the invention; -
FIG. 5B is a schematic bottom view, side view, and top view of the anchoring unit shown inFIG. 5A , according to the invention; -
FIG. 6A is a schematic perspective view of a third embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body defining at least one slit and anchoring members coupled to the body in a helical arrangement, according to the invention; -
FIG. 6B is a schematic bottom view, side view, and top view of the anchoring unit shown inFIG. 6A , according to the invention; -
FIG. 7A is a schematic perspective view of a fourth embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body, anchoring members coupled to the body, and connecting elements coupling distal ends of the anchoring members to one another, according to the invention; -
FIG. 7B is a schematic bottom view, side view, and top view of the anchoring unit shown inFIG. 7A , according to the invention; -
FIG. 8A is a schematic perspective view of a fifth and a sixth embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body and at least one anchoring member, according to the invention; -
FIG. 8B is a schematic bottom view, side view, and top view of the anchoring unit shown inFIG. 8A , according to the invention; -
FIG. 9A is a schematic perspective view of a seventh embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body and anchoring members coupled to the body, the anchoring members increasing in width as the anchoring members extend away from the body, according to the invention; -
FIG. 9B is a schematic bottom view, side view, and top view of the anchoring unit shown inFIG. 9A , according to the invention; -
FIG. 10A is a schematic perspective view of an eighth embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body and anchoring members coupled to the body, each anchoring member having a distal end that also couples to the body via a leaf spring, according to the invention; -
FIG. 10B is a schematic bottom view, side view, and top view of the anchoring unit shown inFIG. 10A , according to the invention; -
FIG. 11A is a schematic perspective view of a ninth embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body and distally-biased anchoring members, according to the invention; -
FIG. 11B is a schematic bottom view, side view, and top view of the anchoring unit shown inFIG. 11A , according to the invention; -
FIG. 12A is a schematic perspective view of a tenth embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body and curled anchoring members, each anchoring member curled to include a proximally-biased section and a distally-biased section, according to the invention; -
FIG. 12B is a schematic bottom view, side view, and top view of the anchoring unit shown inFIG. 12A , according to the invention; -
FIG. 13A is a schematic perspective view of an eleventh embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body and articulated anchoring members, each anchoring member including a proximally-biased section and a distally-biased section, according to the invention; -
FIG. 13B is a schematic bottom view, side view, and top view of the anchoring unit shown inFIG. 13A , according to the invention; -
FIG. 14 is a schematic perspective view of one embodiment of a portion of a lead body of an electrical stimulation system on which four similarly-shaped anchoring units are disposed, according to the invention; -
FIG. 15 is a schematic perspective view of one embodiment of a portion of a lead body of an electrical stimulation system on which nine differently-shaped anchoring units are disposed, according to the invention; and -
FIG. 16 is a schematic overview of one embodiment of components of a stimulation system, including an electronic subassembly disposed within a control module, according to the invention. - The present invention is directed to the area of implantable electrical stimulation systems and methods of making and using the systems. The present invention is also directed to implantable electrical stimulation leads having one or more anchoring units coupled to the lead to facilitate fixing of the lead within patient tissue, as well as methods of making and using the leads, anchoring units, and electrical stimulation systems.
- Suitable implantable electrical stimulation systems include, but are not limited to, an electrode lead (“lead”) with one or more electrodes disposed on a distal end of the lead and one or more terminals disposed on one or more proximal ends of the lead. Leads include, for example, percutaneous leads, paddle leads, and cuff leads. Examples of electrical stimulation systems with leads are found in, for example, U.S. Pat. Nos. 6,181,969; 6,516,227; 6,609,029; 6,609,032; and 6,741,892; and U.S. patent application Ser. Nos. 10/353,101, 10/503,281, 11/238,240; 11/319,291; 11/327,880; 11/375,638; 11/393,991; and 11/396,309, all of which are incorporated by reference.
-
FIG. 1 illustrates schematically one embodiment of anelectrical stimulation system 100. The electrical stimulation system includes a control module (e.g., a stimulator or pulse generator) 102, apaddle body 104, and at least onelead body 106 coupling thecontrol module 102 to thepaddle body 104. Thepaddle body 104 and the one or morelead bodies 106 form a lead. Thepaddle body 104 typically includes an array ofelectrodes 134. Thecontrol module 102 typically includes anelectronic subassembly 110 and anoptional power source 120 disposed in a sealedhousing 114. Thecontrol module 102 typically includes a connector 144 (FIGS. 2 and 3A , see also 322 and 350 ofFIG. 3B ) into which the proximal end of the one or morelead bodies 106 can be plugged to make an electrical connection via conductive contacts on thecontrol module 102 and terminals (e.g., 310 inFIGS. 3A and 336 ofFIG. 3B ) on each of the one or morelead bodies 106. It will be understood that the electrical stimulation system can include more, fewer, or different components and can have a variety of different configurations including those configurations disclosed in the electrical stimulation system references cited herein. For example, instead of apaddle body 104, theelectrodes 134 can be disposed in an array at or near the distal end of thelead body 106 forming a percutaneous lead, as illustrated inFIG. 2 . A percutaneous lead may be isodiametric along the length of the lead. In addition, one or more lead extensions 312 (seeFIG. 3B ) can be disposed between the one or morelead bodies 106 and thecontrol module 102 to extend the distance between the one or morelead bodies 106 and thecontrol module 102 of the embodiments shown inFIGS. 1 and 2 . - The electrical stimulation system or components of the electrical stimulation system, including one or more of the
lead bodies 106, thepaddle body 104, and thecontrol module 102, are typically implanted into the body of a patient. The electrical stimulation system can be used for a variety of applications including, but not limited to, brain stimulation, neural stimulation, spinal cord stimulation, muscle stimulation, and the like. - The
electrodes 134 can be formed using any conductive, biocompatible material. Examples of suitable materials include metals, alloys, conductive polymers, conductive carbon, and the like, as well as combinations thereof. The number ofelectrodes 134 in the array ofelectrodes 134 may vary. For example, there can be two, four, six, eight, ten, twelve, fourteen, sixteen, ormore electrodes 134. As will be recognized, other numbers ofelectrodes 134 may also be used. - The electrodes of the
paddle body 104 or one or morelead bodies 106 are typically disposed in, or separated by, a non-conductive, biocompatible material including, for example, silicone, polyurethane, polyetheretherketone (“PEEK”), epoxy, and the like or combinations thereof. Thepaddle body 104 and one or morelead bodies 106 may be formed in the desired shape by any process including, for example, molding (including injection molding), casting, and the like. Electrodes and connecting wires can be disposed onto or within a paddle body either prior to or subsequent to a molding or casting process. The non-conductive material typically extends from the distal end of the lead to the proximal end of each of the one or morelead bodies 106. The non-conductive, biocompatible material of thepaddle body 104 and the one or morelead bodies 106 may be the same or different. Thepaddle body 104 and the one or morelead bodies 106 may be a unitary structure or can be formed as two separate structures that are permanently or detachably coupled together. - Terminals (e.g., 310 in
FIGS. 3A and 336 ofFIG. 3B ) are typically disposed at the proximal end of the one or morelead bodies 106 for connection to corresponding conductive contacts (e.g., 314 inFIGS. 3A and 340 ofFIG. 3B ) in connectors (e.g., 144 inFIGS. 1-3A and 322 and 350 ofFIG. 3B ) disposed on, for example, the control module 102 (or to other devices, such as conductive contacts on a lead extension, an operating room cable, or an adaptor). Conductive wires (“conductors”) (not shown) extend from the terminals (e.g., 310 inFIGS. 3A and 336 ofFIG. 3B ) to theelectrodes 134. Typically, one ormore electrodes 134 are electrically coupled to a terminal (e.g., 310 inFIGS. 3A and 336 ofFIG. 3B ). In some embodiments, each terminal (e.g., 310 inFIGS. 3A and 336 ofFIG. 3B ) is only connected to oneelectrode 134. The conductive wires may be embedded in the non-conductive material of the lead or can be disposed in one or more lumens (not shown) extending along the lead. In some embodiments, there is an individual lumen for each conductive wire. In other embodiments, two or more conductive wires may extend through a lumen. There may also be one or more lumens (not shown) that open at, or near, the proximal end of the lead, for example, for inserting a stylet rod to facilitate placement of the lead within a body of a patient. Additionally, there may also be one or more lumens (not shown) that open at, or near, the distal end of the lead, for example, for infusion of drugs or medication into the site of implantation of thepaddle body 104. In at least one embodiment, the one or more lumens may be flushed continually, or on a regular basis, with saline, epidural fluid, or the like. In at least some embodiments, the one or more lumens can be permanently or removably sealable at the distal end. - In at least some embodiments, leads are coupled to connectors disposed on control modules. In
FIG. 3A , alead 308 is shown configured and arranged for insertion to thecontrol module 102. Theconnector 144 includes aconnector housing 302. Theconnector housing 302 defines at least oneport 304 into which aproximal end 306 of a lead 308 withterminals 310 can be inserted, as shown bydirectional arrow 312. Theconnector housing 302 also includes a plurality ofconductive contacts 314 for eachport 304. When thelead 308 is inserted into theport 304, theconductive contacts 314 can be aligned with theterminals 310 on thelead 308 to electrically couple thecontrol module 102 to the electrodes (134 ofFIG. 1 ) disposed at a distal end of thelead 308. Examples of connectors in control modules are found in, for example, U.S. Pat. No. 7,244,150 and U.S. patent application Ser. No. 11/532,844, which are incorporated by reference. - In
FIG. 3B , aconnector 322 is disposed on alead extension 324. Theconnector 322 is shown disposed at adistal end 326 of thelead extension 324. Theconnector 322 includes a connector housing 328. The connector housing 328 defines at least oneport 330 into which aproximal end 332 of a lead 334 withterminals 336 can be inserted, as shown bydirectional arrow 338. The connector housing 328 also includes a plurality ofconductive contacts 340. When thelead 334 is inserted into theport 330, theconductive contacts 340 disposed in the connector housing 328 can be aligned with theterminals 336 on thelead 334 to electrically couple thelead extension 324 to the electrodes (134 ofFIG. 1 ) disposed at a distal end (not shown) of thelead 334. - In at least some embodiments, the proximal end of a lead extension is similarly configured and arranged as a proximal end of a lead. The
lead extension 324 may include a plurality of conductive wires (not shown) that electrically couple theconductive contacts 340 to aproximal end 348 of thelead extension 324 that is opposite to thedistal end 326. In at least some embodiments, the conductive wires disposed in thelead extension 324 can be electrically coupled to a plurality of terminals (not shown) disposed on theproximal end 348 of thelead extension 324. In at least some embodiments, theproximal end 348 of thelead extension 324 is configured and arranged for insertion into a connector disposed in another lead extension. In other embodiments, theproximal end 348 of thelead extension 324 is configured and arranged for insertion into a connector disposed in a control module. As an example, inFIG. 3B theproximal end 348 of thelead extension 324 is inserted into aconnector 350 disposed in acontrol module 352. - Electrode placement can be important for obtaining efficacious patient response to stimulation. Sometimes a distal end of a lead may migrate from an intended treatment site over time due to patient movement. When a distal end of a lead migrates far enough away from the intended treatment site, a loss of efficacy may occur and surgical re-implantation may become necessary to re-establish efficacy.
- One way to reduce migration of the distal end of an implanted lead is to anchor the distal end of the lead within patient tissue. In at least some embodiments, anchoring units are described for use with implantable electrical stimulation systems. In at least some embodiments, one or more anchoring units may be disposed along a longitudinal axis of the lead body (see e.g.,
FIGS. 13 and 14 ). One or more anchoring units may be positioned on the lead body distal to the electrodes, in-between two or more electrodes, proximal to the electrodes, or any combination thereof. The anchoring units may be different sizes and shapes. When multiple anchoring units are disposed on a lead body, the anchoring units may either be all of similar size and shape, or one or more of the anchoring units may have different sizes or shapes from other anchoring units disposed on the lead body. Furthermore, adjacent anchoring units disposed on the lead body may be evenly-spaced, or irregularly spaced from one another. In at least some embodiments, the shapes, sizes, or arrangements of anchoring units disposed on a lead body may be selected based, at least in part, on a specific indication or a specific anatomical location. - The anchoring units may be formed from any suitable biocompatible material including, for example, polyurethane, silicone rubber, polytetrafluoroethylene, polyethylene, nylon, metal, nitinol, and the like or combinations thereof. In at least some embodiments, at least a portion of the anchoring units are formed integrally with the lead body (e.g., by overmolding a body of an anchoring unit to the lead body, reflowing a body of an anchoring unit to the lead body, or the like). In at least some other embodiments, anchoring units may be coupled to the lead body at selected locations along a longitudinal axis of the lead using any suitable bonding process including, for example, chemical bonding, welding, interference fit, and the like or combinations thereof.
-
FIG. 4A is a schematic perspective view of a first embodiment of ananchoring unit 402 for an electrical stimulation system. Theanchoring unit 402 includes abody 404 and one ormore anchoring members 406. Thebody 404 includes afirst end 408 and asecond end 410 and is configured and arranged to be disposed over at least a portion of an outer surface of the lead body (see e.g.,FIGS. 13 and 14 ). In at least some embodiments, thefirst end 408 is positioned more distally than thesecond end 410 when theanchoring unit 402 is disposed on the lead body (106 inFIG. 1 ). The anchoringmembers 406 each include aproximal end 412, adistal end 414, and alongitudinal axis 415 defined by afirst side 416 and asecond side 418. - In some embodiments, the anchoring members form a spiral arrangement. In
FIG. 4A , thefirst sides 416 of the anchoringmembers 406 are arcing leading edges and thesecond sides 418 are lagging edges, thereby forming an arcinglongitudinal axis 415. In at least some embodiments, the laggingsecond sides 418 are also arcing. In at least some embodiments, thefirst sides 416 of the anchoringmembers 406 are similarly-arced to form a spiral pattern. In at least some embodiments, thefirst sides 416 of the anchoringmembers 406 are longer in length than thesecond sides 418 of the anchoringmembers 406. In at least some embodiments, thefirst side 416 and thesecond side 418 of the anchoringmembers 402 taper inward such that the proximal ends 412 are wider than the distal ends 414. - In at least some embodiments, the
distal end 414 of at least one of the anchoringmembers 406 tapers to form a point. In a preferred embodiment, the point is rounded. It may be an advantage to employ one ormore anchoring units 402 with anchoringmembers 406 that taper to points because a medical practitioner may be able to rotate the lead to further engage theanchor members 406 within patient tissue during implantation, thereby increasing the anchoring ability of the lead. -
FIG. 4B is a schematic bottom view, side view, and top view of theanchoring unit 402. In at least some embodiments, the anchoringmembers 406 extend from thesecond end 410 of thebody 404 along a common transverse axis of thebody 404. In at least some embodiments, the anchoringmembers 406 are proximally biased. In other words, when theanchoring unit 402 is disposed on the lead body (106 inFIG. 1 ) so that thefirst end 408 is more distal on the lead body (106 inFIG. 1 ) than thesecond end 410, the anchoringmembers 406 form an angle with the longitudinal axis of thebody 404 that is at least ninety degrees, as shown byangle Θ 420. - In some embodiments, the anchoring unit includes a single anchoring member that extends from the body in a helical arrangement.
FIG. 5A is a schematic perspective view of a second embodiment of ananchoring unit 502. Theanchoring unit 502 includes abody 504 and one anchoringmember 506. Thebody 504 includes afirst end 508 and asecond end 510 and the anchoringmember 506 includes aproximal end 512, adistal end 514, a longitudinal axis 515, afirst side 516, and asecond side 518. - In at least some embodiments, the
proximal end 512 of the anchoringmember 506 extends at least three-fourths of one complete revolution around a circumference of thebody 504. In at least some embodiments, theproximal end 512 of the anchoringmember 506 extends at least one complete revolution around the circumference of thebody 504. In at least some embodiments, theproximal end 512 of the anchoringmember 506 couples to thebody 504 in a helical arrangement along a longitudinal axis of thebody 504 such that thefirst side 516 and thesecond side 518 of the anchoringmember 506 couple to thebody 504 along different transverse points along the longitudinal axis of thebody 504. In at least some embodiments, the pitch and the number of revolutions of the anchoringmember 506 around a circumference of thebody 504 may be tailored to the specific indication or the specific anatomical location of the implantation of the lead body (106 inFIG. 1 ) to which one or more of the anchoringunits 502 may be coupled. - In at least some embodiments, the
first side 516 and thesecond side 518 of the anchoringmember 502 taper outward such that thedistal end 514 is wider than theproximal end 512. In at least some embodiments, thefirst side 516 and thesecond side 518 of the anchoringmember 502 taper inward such that theproximal end 512 is wider than thedistal end 514. In at least some embodiments, theproximal end 512 and thedistal end 514 are of approximately equal width. -
FIG. 5B is a schematic bottom view, side view, and top view of theanchoring unit 502. In at least some embodiments, the anchoringmember 506 is proximally biased. In other words, when theanchoring unit 502 is disposed on the lead body (106 inFIG. 1 ) so that thefirst end 508 is more distal on the lead body (106 inFIG. 1 ) than thesecond end 510, the anchoringmember 506 forms an angle with the longitudinal axis of thebody 504 that is at least ninety degrees, as shown byangle Θ 520. - In some embodiments, the body includes one or more tapered anchoring members.
FIG. 6A is a schematic perspective view of a third embodiment of ananchoring unit 602. Theanchoring unit 602 includes abody 604 and at least one anchoringmember 606. Thebody 604 includes afirst end 608 and asecond end 610. The anchoringmember 606 includes aproximal end 612, adistal end 614, alongitudinal axis 615, afirst side 616, and asecond side 618. Thebody 604 also defines one ormore slits 620 along at least portion of thesecond end 610 of thebody 604 between adjacent anchoringmembers 606. In at least some embodiments, the one ormore slits 616 extend in a direction that is parallel to a longitudinal axis of thebody 604. In at least some embodiments, the one ormore slits 616 facilitate the anchoringmembers 606 lying flat (e.g., during insertion of the lead into a patient). - In at least some embodiments, the
first side 616 and thesecond side 618 of the anchoringmember 602 taper outward such that thedistal end 614 is wider than theproximal end 612. In at least some embodiments, the proximal ends 612 of two ormore anchoring members 606 extend from thebody 604 in a helical pattern along a longitudinal axis of thebody 604 such that thefirst side 616 and thesecond side 618 of each of two or more the anchoringunits 602 extend from thebody 604 along different transverse axes of thebody 604. In at least some embodiments, the pitch and the number of revolutions of the anchoringmembers 606 around a circumference of thebody 604 may be tailored to the specific indication or the specific anatomical location of the implantation of the lead body (106 inFIG. 1 ) to which one or more of the anchoringunits 602 may be coupled. -
FIG. 6B is a schematic bottom view, side view, and top view of theanchoring unit 602. In at least some embodiments, the anchoringmembers 606 are proximally biased. In other words, when theanchoring unit 602 is disposed on the lead body (106 inFIG. 1 ) so that thefirst end 608 is more distal on the lead body (106 inFIG. 1 ) than thesecond end 610, the anchoringmembers 606 form an angle with the longitudinal axis of thebody 604 that is at least ninety degrees, as shown byangle Θ 622. - In some embodiments, one or more connecting elements couple to adjacent anchoring members.
FIG. 7A is a schematic perspective view of a fourth embodiment of ananchoring unit 702. Theanchoring unit 702 includes abody 704 and at least one anchoringmember 706. Thebody 704 includes afirst end 708 and asecond end 710. Theanchoring unit 702 includes abody 704 and at least one anchoringmember 706. Thebody 704 includes afirst end 708 and asecond end 710. The anchoringmember 706 includes aproximal end 712, adistal end 714, alongitudinal axis 715, afirst side 716, and asecond side 718. - In at least some embodiments, the
first side 716 and thesecond side 718 of the anchoringmember 706 taper such that theproximal end 712 of the anchoringmember 706 is wider than thedistal end 714. In at least some embodiments, thedistal end 714 of at least one of the anchoringmembers 706 tapers to form a point. In a preferred embodiment, the point is rounded. - In at least some embodiments, two or more of the anchoring
members 706 may be coupled to one another by a connectingelement 720. For example, twoadjacent anchoring members 706 may be coupled to one another by one or moreconnecting elements 720. In at least some embodiments, thedistal end 714 of each anchoringmember 706 is coupled to thedistal end 714 of each adjacent anchoringmember 706 by connectingelements 720. In at least some embodiments, a single connectingelement 720 connects adjacent distal ends 714 to one another. In at least some embodiments, a plurality of connectingelements 720 connect adjacent distal ends 714 to one another. In at least some other embodiments, a single connectingelement 720 connects each of the adjacent distal ends 714 together. In at least some embodiments, anopen space 722 is formed between the connectingelement 720 andadjacent anchoring members 706. - It will be understood that the one or more
connecting elements 720 may coupleadjacent anchoring members 706 at locations along the longitudinal axis of the anchoringmembers 706 other than the distal ends 714. For example, the connecting element may couple to a given anchoringmember 706 at a position between theproximal end 712 and adistal end 714 of the anchoringmember 706. In at least some embodiments, the connectingmembers 720 are formed with theanchoring unit 702. In at least some other embodiments, the connectingmembers 720 are formed subsequently assembled. - Additionally, in at least some embodiments, the connecting
elements 702 are configured and arranged to fold flat against the lead body (106 inFIG. 1 ). For example, in at least some embodiments, the connectingelements 720 are configured and arranged to fold into open spaces between the anchoringmembers 706 when the anchoringmembers 706 are folded against the lead body (106 inFIG. 1 ). In at least some embodiments, at least one of the connectingelements 702 includes at least one bend to facilitate folding flat. In at least some embodiments, at least one of the connectingelements 702 is articulated to facilitate folding flat. In at least some embodiments, the connectingelements 720 increase the anchoring ability of theanchoring unit 702 by further facilitating tissue ingrowth. -
FIG. 7B is a schematic bottom view, side view, and top view of theanchoring unit 702. In at least some embodiments, the anchoringmembers 706 extend from thesecond end 710 of thebody 704 along a common transverse axis of thebody 704. In at least some embodiments, the anchoringmembers 706 are proximally biased. In other words, when theanchoring unit 702 is disposed on the lead body (106 inFIG. 1 ) so that thefirst end 708 is more distal on the lead body (106 inFIG. 1 ) than thesecond end 710, the anchoringmembers 706 form an angle with the longitudinal axis of thebody 704 that is at least ninety degrees, as shown byangle Θ 724. - In at least some embodiments, the connective element may include a membrane coupling at least two adjacent anchoring members to one another.
FIG. 8A is a schematic perspective view of a fifth embodiment of ananchoring unit 802. Theanchoring unit 802 includes abody 804 and at least one anchoringmember 806. Thebody 804 includes afirst end 808 and asecond end 810. Theanchoring unit 802 includes abody 804 and at least one anchoringmember 806. Thebody 804 includes afirst end 808 and asecond end 810. The anchoringmember 806 includes aproximal end 812, adistal end 814, alongitudinal axis 815, afirst side 816, and asecond side 818. - In at least some embodiments, the
first side 816 and thesecond side 818 of the anchoringmember 806 taper such that theproximal end 812 of the anchoringmember 806 is wider than thedistal end 814. In at least some embodiments, thedistal end 814 of at least one of the anchoringmembers 806 tapers to form a point. In a preferred embodiment, the point is rounded. In at least some embodiments, thefirst side 816 and thesecond side 818 of the anchoringmember 806 taper such that thedistal end 814 of the anchoringmember 806 is wider than theproximal end 812. In at least some embodiments, thefirst side 816 and thesecond side 818 of the anchoringmember 806 are of approximately equal width. - In at least some embodiments, two or more of the anchoring
members 806 may be coupled to one another by a connectingelement 820. In some embodiments, the connectingelement 820 comprises a membrane, or sheath, that couples two or more of the anchoringmembers 806 to one another. In at least some embodiments, theconnective element 820 has a thickness that is substantially thinner than the anchoringmembers 806. In at least some embodiments, the connectingelement 820 forms a complete revolution around thebody 804. In at least some embodiments, theconnective element 820 covers at least a portion of at least one of the anchoringmembers 806. In at least some embodiments, the connectingelement 820 substantially entirely covers each of the anchoringmembers 806. In at least some embodiments, the connectingelement 820 completely covers each of the anchoringmembers 806. In at least some embodiments, at least a portion of at least one of the anchoringmembers 806 may need to deform onto itself while in a folded position (e.g., during insertion of the lead into a patient). -
FIG. 8B is a schematic bottom view, side view, and top view of theanchoring unit 802. In at least some embodiments, the anchoringmembers 806 extend from thesecond end 810 of thebody 804 along a common transverse axis of thebody 804. In at least some embodiments, the anchoringmembers 806 are proximally biased. In other words, when theanchoring unit 802 is disposed on the lead body (106 inFIG. 1 ) so that thefirst end 808 is more distal on the lead body (106 inFIG. 1 ) than thesecond end 810, the anchoringmembers 806 form an angle with the longitudinal axis of thebody 804 that is at least ninety degrees, as shown by angle Θ 822. - In a sixth embodiment of the anchoring unit, also shown by
FIGS. 8A and 8B , theanchoring unit 802 includes asingle anchoring member 806 that extends around the entire circumference of thebody 804. In some embodiments, the anchoringmember 806 is a constant thickness. In at least some other embodiments, the thickness of the anchoringmember 806 may vary. In at least some embodiments, the anchoringmember 806 may define one or more cutouts for promoting tissue ingrowth. - In some embodiments, the anchoring members include tapered anchoring members.
FIG. 9A is a schematic perspective view of a seventh embodiment of ananchoring unit 902. Theanchoring unit 902 includes abody 904 and at least one anchoringmember 906. Thebody 904 includes afirst end 908 and asecond end 910. Theanchoring unit 902 includes abody 904 and at least one anchoringmember 906. Thebody 904 includes afirst end 908 and asecond end 910. The anchoringmember 906 includes aproximal end 912, adistal end 914, alongitudinal axis 915, afirst side 916, and asecond side 918. - In at least some embodiments, the
first side 916 and thesecond side 918 of the anchoringmembers 906 taper outward such that thedistal end 914 is wider than theproximal end 912. In at least some embodiments, the anchoringmembers 906 extend from thesecond end 910 of thebody 904 along a common transverse axis of thebody 904. In at least some embodiments, two anchoringmembers 906 are disposed on opposing portions of thebody 904 such that the two anchoringmembers 906 extend in opposite directions from thebody 904. In at least some embodiments, the sum of the arc lengths of the distal ends 914 of the anchoringmembers 906 are no greater than the circumference of thebody 904. In at least some embodiments, the widest portions of the anchoringmembers 906 have lengths that are at least as long as the diameter of thebody 904. -
FIG. 9B is a schematic bottom view, side view, and top view of theanchoring unit 902. In at least some embodiments, the anchoringmembers 906 are proximally biased. In other words, when theanchoring unit 902 is disposed on the lead body (106 inFIG. 1 ) so that thefirst end 908 is more distal on the lead body (106 inFIG. 1 ) than thesecond end 910, the anchoringmembers 906 form an angle with the longitudinal axis of thebody 904 that is at least ninety degrees, as shown by angle Θ 920. - In some embodiments, the anchoring members include a secondary connecting member, such as a leaf spring, coupling the anchoring member to the body of the anchoring unit.
FIG. 10A is a schematic perspective view of an eighth embodiment of ananchoring unit 1002. Theanchoring unit 1002 includes abody 1004 and at least oneanchoring member 1006. Thebody 1004 includes afirst end 1008 and asecond end 1010. Theanchoring unit 1002 includes abody 1004 and at least oneanchoring member 1006. Thebody 1004 includes afirst end 1008 and asecond end 1010. The anchoringmember 1006 includes aproximal end 1012, adistal end 1014, alongitudinal axis 1015, afirst side 1016, and asecond side 1018. - In at least some embodiments, the
first side 1016 and thesecond side 1018 of the anchoringmember 1006 taper such that theproximal end 1012 of the anchoringmember 1006 is wider than thedistal end 1014. In at least some embodiments, thedistal end 1014 of at least one of theanchoring members 1006 tapers to form a point. In a preferred embodiment, the point is rounded. In at least some embodiments, thefirst side 1016 and thesecond side 1018 of the anchoringmember 1006 taper such that thedistal end 1014 of the anchoringmember 1006 is wider than theproximal end 1012. In at least some embodiments, thefirst side 1016 and thesecond side 1018 of the anchoringmember 1006 are of approximately equal width. - In at least some embodiments, the
anchoring unit 1002 further includes at least one secondary connectingmember 1020 coupling thebody 1004 to thedistal end 1014 of one of theanchoring members 1006. In at least some embodiments, the at least one secondary connectingmember 1020 is a leaf spring. In at least some embodiments, the secondary connectingmember 1020 forms a solid surface between thebody 1004 and the anchoringmember 1006. In at least some other embodiments, the secondary connectingmember 1020 forms at least onecutout 1022 between thebody 1004, anchoringmember 1006, and the secondary connectingmember 1020. It may be a particular advantage of theanchoring unit 1002 that tissue ingrowth may occur in thecutouts 1022 to at least partially fill thecutouts 1022 with tissue to further increase the anchoring ability of theanchoring unit 1002. - In at least some embodiments, when the
anchoring members 1006 are folded against the lead body (e.g., during insertion of the lead), the secondary connectingmember 1020 stretches, thereby storing potential energy. The stored potential energy may facilitate anchoring of the anchoringmember 1006 within patient tissue when theanchoring unit 1002 is released from the insertion needle and the stored potential energy is released. -
FIG. 10B is a schematic bottom view, side view, and top view of theanchoring unit 1002. In at least some embodiments, the anchoringmembers 1006 extend from thesecond end 1010 of thebody 1004 along a common transverse axis of thebody 1004. In at least some embodiments, the anchoringmembers 1006 are proximally biased. In other words, when theanchoring unit 1002 is disposed on the lead body (106 inFIG. 1 ) so that thefirst end 1008 is more distal on the lead body (106 inFIG. 1 ) than thesecond end 1010, the anchoringmembers 1006 form an angle with the longitudinal axis of thebody 1004 that is at least ninety degrees, as shown byangle Θ 1024. - In some embodiments, the one or more anchoring members are distally biased.
FIG. 11A is a schematic perspective view of a ninth embodiment of ananchoring unit 1102. Theanchoring unit 1102 includes abody 1104 and at least oneanchoring member 1106. Thebody 1104 includes afirst end 1108 and asecond end 1110. Theanchoring unit 1102 includes abody 1104 and at least oneanchoring member 1106. Thebody 1104 includes afirst end 1108 and asecond end 1110. The anchoringmember 1106 includes aproximal end 1112, adistal end 1114, alongitudinal axis 1115, afirst side 1116, and a second side 1118. - In at least some embodiments, the
first side 1116 and the second side 1118 of the anchoringmember 1106 taper such that theproximal end 1112 of the anchoringmember 1106 is wider than thedistal end 1114. In at least some embodiments, thedistal end 1114 of at least one of theanchoring members 1106 tapers to form a rounded point. In at least some embodiments, thefirst side 1116 and the second side 1118 of the anchoringmember 1106 taper such that thedistal end 1114 of the anchoringmember 1106 is wider than theproximal end 1112. In at least some embodiments, thefirst side 1116 and the second side 1118 of the anchoringmember 1106 are of approximately equal width. - In at least some embodiments, when the
anchoring unit 1102 is separated from an insertion needle during insertion of the lead, the anchoringmembers 1106 are configured and arranged to extend within patient tissue. In some instances, the anchoringmembers 1106 are able to extend to distally-biased positions and in other instances they are not, depending on, for example, the amount of open space around theanchoring unit 1102 and the hardness of the surrounding tissue. For example, anchoringmembers 1106 may not be able to extend to distally-biased positions when positioned in a narrow space between hard tissues, such as bones or cartilage. When theanchoring members 1106 do extend to distally-biased positions, the anchoringmembers 1106 may resist withdrawal of the lead to which theanchoring unit 1102 is coupled. When patient tissue prevents theanchoring members 1106 from extending to distally-biased positions, the anchoringmembers 1106 fix theanchoring unit 1102 in position by the force of theanchoring members 1106 pressing against tissue in a manner similar to the proximally-biased anchoring members, discussed above. It may be an advantage of distally-biasedanchoring members 1106 that, should an explant be necessary for the lead to which theanchoring unit 1102 is coupled, distally-biased anchoring members may be easier to remove from patient tissue than similarly-sized proximally-biased anchoring members. -
FIG. 11B is a schematic bottom view, side view, and top view of theanchoring unit 1102. In at least some embodiments, the anchoringmembers 1106 extend from thesecond end 1110 of thebody 1104 along a common transverse axis of thebody 1104. In at least some embodiments, the anchoringmembers 1106 are distally biased. In other words, when theanchoring unit 1102 is disposed on the lead body (106 inFIG. 1 ) so that thefirst end 1108 is more distal on the lead body (106 inFIG. 1 ) than thesecond end 1110, the anchoringmembers 1106 form an angle with the longitudinal axis of thebody 1104 that is no more than ninety degrees, as shown by angle Θ 1120. - In some embodiments, the one or more anchoring members are capable of curling such that a portion of at least one of the anchoring members is distally biased and a portion of the same anchoring member is proximally biased.
FIG. 12A is a schematic perspective view of a tenth embodiment of ananchoring unit 1202. Theanchoring unit 1202 includes abody 1204 and at least oneanchoring member 1206. Thebody 1204 includes afirst end 1208 and asecond end 1210. Theanchoring unit 1202 includes abody 1204 and at least oneanchoring member 1206. Thebody 1204 includes afirst end 1208 and asecond end 1210. The anchoringmember 1206 includes aproximal end 1212, adistal end 1214, a curledlongitudinal axis 1215, afirst side 1216, and asecond side 1218. In at least some embodiments, the anchoringmembers 1206 have an arc-shaped transverse profile. - In at least some embodiments, the
first side 1216 and thesecond side 1218 of the anchoringmember 1206 taper such that theproximal end 1212 of the anchoringmember 1206 is wider than thedistal end 1214. In at least some embodiments, thedistal end 1214 of at least one of theanchoring members 1206 tapers to form a rounded point. In at least some embodiments, thefirst side 1216 and thesecond side 1218 of the anchoringmember 1206 taper such that thedistal end 1214 of the anchoringmember 1206 is wider than theproximal end 1212. In at least some embodiments, thefirst side 1216 and thesecond side 1218 of the anchoringmember 1206 are of approximately equal width. - In at least some embodiments, the anchoring
members 1206 are configured and arranged to lie flat during insertion of the lead and curl upon separation from an insertion needle. In at least some embodiments, the anchoringmembers 1206 have an arc-shaped transverse profile that facilitates theanchoring members 1206 lying flat against the lead. In at least some embodiments, when theanchoring unit 1202 is separated from an insertion needle during insertion of the lead, the anchoringmembers 1206 are configured and arranged to curl up such that theanchoring members 1206 extend within patient tissue. The anchoring members may include a metal, such as nitinol, or a polymer that is configured and arranged to curl when unconstrained. In some instances, the anchoringmembers 1206 are able to extend to distally-biased positions and in other instances they are not, depending on, for example, the amount of open space around theanchoring unit 1202 and the hardness of the surrounding tissue. For example, anchoringmembers 1206 may not be able to extend to distally-biased positions when positioned in a narrow space between hard tissues, such as bones or cartilage. When theanchoring members 1206 do extend to distally-biased positions, the anchoringmembers 1206 may resist withdrawal of the lead to which theanchoring unit 1202 is coupled. When patient tissue prevents theanchoring members 1206 from extending to distally-biased positions, the anchoringmembers 1206 fix theanchoring unit 1202 in position by the force of theanchoring members 1206 pressing against tissue in a manner similar to the proximally-biased anchoring members, discussed above. -
FIG. 12B is a schematic bottom view, side view, and top view of theanchoring unit 1202. In at least some embodiments, the anchoringmembers 1206 extend from thesecond end 1210 of thebody 1204 along a common transverse axis of thebody 1104. In at least some embodiments, at least one of theanchoring members 1206 is configured and arranged to curl up such that a portion of that anchoring member is proximally biased and a portion of that anchoring member is distally biased. - In some embodiments, the one or more anchoring members extend from the body at the second end of the body, which, as discussed above, is the end of the body that is positioned more proximally than the first end when the anchoring unit is disposed on the lead body (106 in
FIG. 1 ). In some embodiments, the one or more anchoring members are articulated.FIG. 13A is a schematic perspective view of an eleventh embodiment of ananchoring unit 1302. Theanchoring unit 1302 includes abody 1304 and at least oneanchoring member 1306. Thebody 1304 includes afirst end 1308 and asecond end 1310. Theanchoring unit 1302 includes abody 1304 and at least oneanchoring member 1306. Thebody 1304 includes afirst end 1308 and asecond end 1310. The anchoringmember 1306 includes aproximal end 1312, adistal end 1314, a longitudinal axis 1315, afirst side 1316, and asecond side 1318. - At least one of the
anchoring members 1306 includes at least onearticulation 1320 dividing the anchoringmember 1306 into a plurality of sections. In at least one embodiment, thearticulation 1320 divides the anchoringmember 1306 into aproximal section 1322 and adistal section 1324. In at least some embodiments, theproximal section 1322 includes at least onecutout 1326. It may be a particular advantage of theanchoring unit 1302 that tissue may at least partially fill thecutouts 1326 defined in theproximal section 1322 of the anchoringmember 1306 to further increase the anchoring ability of theanchoring unit 1302. In at least some embodiments, thedistal sections 1324 of theanchoring members 1306 are configured and arranged to fold into thecutouts 1326 defined in theproximal sections 1322 of the anchoring members 1306 (e.g., during insertion of the lead). - In at least some embodiments, the
proximal section 1322 of at least one of theanchoring members 1306 is wider than thedistal section 1324 of the anchoringmember 1306. In at least some embodiments, thedistal end 1314 of at least one of theanchoring members 1306 tapers to form a point. In a preferred embodiment, the point is rounded. In at least some embodiments, theproximal section 1314 of at least one of theanchoring members 1306 is narrower than thedistal section 1316 of the anchoringmember 1306. In at least some embodiments, theproximal section 1314 of at least one of theanchoring members 1306 is of approximately equal width to thedistal section 1316 of the anchoringmember 1306. -
FIG. 13B is a schematic bottom view, side view, and top view of theanchoring unit 1302. In at least some embodiments, theproximal sections 1322 of theanchoring members 1306 are proximally biased and thedistal sections 1324 of theanchoring members 1306 are distally biased. In other words, when theanchoring unit 1302 is disposed on the lead body (106 inFIG. 1 ) so that thefirst end 1308 is more distal on the lead body (106 inFIG. 1 ) than thesecond end 1310, theproximal sections 1314 of theanchoring members 1306 form an angle with the longitudinal axis of thebody 1304 that are greater than ninety degrees, as shown byangle Θ 1 1328 and thedistal sections 1324 of theanchoring members 1306 form an angle with the longitudinal axis of thebody 1304 that are no greater than ninety degrees, as shown byangle Θ 2 1330. - Unless indicated otherwise, the following characteristics of the anchoring units, or its components, or the corresponding lead apply equally to each of the embodiments shown in
FIG. 4C-13B . In at least some embodiments, the body is substantially tubular-shaped with a diameter and a longitudinal axis that is perpendicular to a transverse axis of the body. In at least some embodiments, the diameter of the body of the anchoring unit is approximately equal to the diameter of the lead body (106 inFIG. 1 ). In at least some embodiments, the longitudinal axis of at least one of the anchoring member is at least half the length of the diameter of the body. In at least some embodiments, the longitudinal axis of at least one of the anchoring members is no less than the length of the diameter of the body. In at least some embodiments, the body is cuff-shaped. In at least some embodiments, the anchoring members extend from the second end of the body (except for anchoring member 1306). In at least some embodiments, the anchoring members are proximally biased (except for anchoringmembers - In at least some embodiments, the longitudinal axis of the anchoring members extend to a distal end. In some embodiments, the anchoring members may have a distal end that is of approximately equal width as the proximal end (except for anchoring
members members members - In at least some embodiments, at least one of the anchoring members is formed integrally with the body. In at least some embodiments, at least one of the anchoring units is formed separately from the body and is coupleable to the body. In at least some embodiments, the anchoring members may include one or more features (e.g., barbs, ridges, fissures, knobs, grooves, and the like) coupled to, or formed with, the anchoring members for facilitating the anchoring ability of the anchoring unit when the anchoring unit is implanted in a patient.
- Any suitable number of anchoring members may be coupled to, or formed with, the body including, for example, one, two, three, four, five, six, seven, eight, nine, ten or more anchoring members. As will be recognized, other numbers of anchoring members may also be coupled to, or formed with, the body.
- In at least some embodiments, the anchoring unit may induce the formation of tissue ingrowth around at least a portion of the anchoring unit within the usable lifespan of the anchoring unit. In at least some embodiments, the usable lifespan may vary depending on the indication and location of the lead to which the anchoring unit is coupled while implanted in a patient. It may be an advantage to have tissue ingrowth around at least a portion of the anchoring unit because the tissue ingrowth may further increase the anchoring ability of the anchoring unit when the anchoring unit is implanted in a patient. In the embodiments shown in
FIGS. 6A-7B and 10A-10B, additional tissue ingrowth may occur between open spaces between components of the anchoring unit (e.g., slits 620,open space 722, and cutout 1022). - In at least some embodiments, the anchoring members are flexible. In at least some embodiments, when the anchoring unit is coupled to a lead body (106 in
FIG. 1 ), the anchoring members are configured and arranged to fold flat against the lead body (106 inFIG. 1 ) during insertion of the lead. For example, when, in at least some embodiments, a lead is inserted into a conventionally-sized insertion needle during implantation of the lead, the anchoring members fold against the lead body (106 inFIG. 1 ) without interfering with one another so that the lead is able to fit into a cannula of the conventionally-sized insertion needle. In at least some embodiments, at least one of the anchoring members is contoured to facilitate the folding of the anchoring members. In the embodiments shown inFIGS. 8A-8B , at least a portion of at least one of the anchoringmembers 806 may need to deform onto itself while in a folded position. - In at least some embodiments, one or more anchoring units may be disposed on the lead body (106 of
FIG. 1 ). In at least some embodiments, multiple anchoring units may be employed which have similarly-shaped anchoring members.FIG. 14 is a schematic perspective view of one embodiment of fouranchoring units 1402 disposed on a portion of alead body 1404. In at least some embodiments, the anchoringunits 1402 are evenly-spaced from one another. In at least some embodiments, at least some of the anchoringunits 1402 are irregularly spaced from one another. In at least some embodiments, at least one of the anchoringunits 1402 may be of a different size from the remaininganchoring units 1402. In at least some embodiments, the anchoring members of different anchoring units are aligned with respect to one another along the longitudinal axis of the lead body. In at least some other embodiments, the anchoring members of different anchoring units are staggered, unaligned, or randomly positioned with respect to other anchoring members along the lead body. - In at least some embodiments, multiple anchoring units may be disposed on a portion of the lead body, at least some of which have differently-shaped anchoring members.
FIG. 15 is a schematic side view of one embodiment of ninedifferent anchoring units lead body 1502. In at least some embodiments, the anchoringunits units units anchoring units -
FIG. 16 is a schematic overview of one embodiment of components of anelectrical stimulation system 1600 including anelectronic subassembly 1610 disposed within a control module. It will be understood that the electrical stimulation system can include more, fewer, or different components and can have a variety of different configurations including those configurations disclosed in the stimulator references cited herein. - Some of the components (for example,
power source 1612,antenna 1618,receiver 1602, and processor 1604) of the electrical stimulation system can be positioned on one or more circuit boards or similar carriers within a sealed housing of an implantable pulse generator, if desired. Anypower source 1612 can be used including, for example, a battery such as a primary battery or a rechargeable battery. Examples of other power sources include super capacitors, nuclear or atomic batteries, mechanical resonators, infrared collectors, thermally-powered energy sources, flexural powered energy sources, bioenergy power sources, fuel cells, bioelectric cells, osmotic pressure pumps, and the like including the power sources described in U.S. Patent Application Publication No. 2004/0059392, incorporated herein by reference. - As another alternative, power can be supplied by an external power source through inductive coupling via the
optional antenna 1618 or a secondary antenna. The external power source can be in a device that is mounted on the skin of the user or in a unit that is provided near the user on a permanent or periodic basis. - If the
power source 1612 is a rechargeable battery, the battery may be recharged using theoptional antenna 1618, if desired. Power can be provided to the battery for recharging by inductively coupling the battery through the antenna to arecharging unit 1616 external to the user. Examples of such arrangements can be found in the references identified above. - In one embodiment, electrical current is emitted by the
electrodes 134 on the paddle or lead body to stimulate nerve fibers, muscle fibers, or other body tissues near the electrical stimulation system. Aprocessor 1604 is generally included to control the timing and electrical characteristics of the electrical stimulation system. For example, theprocessor 1604 can, if desired, control one or more of the timing, frequency, strength, duration, and waveform of the pulses. In addition, theprocessor 1604 can select which electrodes can be used to provide stimulation, if desired. In some embodiments, theprocessor 1604 may select which electrode(s) are cathodes and which electrode(s) are anodes. In some embodiments, theprocessor 1604 may be used to identify which electrodes provide the most useful stimulation of the desired tissue. - Any processor can be used and can be as simple as an electronic device that, for example, produces pulses at a regular interval or the processor can be capable of receiving and interpreting instructions from an
external programming unit 1608 that, for example, allows modification of pulse characteristics. In the illustrated embodiment, theprocessor 1604 is coupled to areceiver 1602 which, in turn, is coupled to theoptional antenna 1618. This allows theprocessor 1604 to receive instructions from an external source to, for example, direct the pulse characteristics and the selection of electrodes, if desired. - In one embodiment, the
antenna 1618 is capable of receiving signals (e.g., RF signals) from anexternal telemetry unit 1606 which is programmed by aprogramming unit 1608. Theprogramming unit 1608 can be external to, or part of, thetelemetry unit 1606. Thetelemetry unit 1606 can be a device that is worn on the skin of the user or can be carried by the user and can have a form similar to a pager, cellular phone, or remote control, if desired. As another alternative, thetelemetry unit 1606 may not be worn or carried by the user but may only be available at a home station or at a clinician's office. Theprogramming unit 1608 can be any unit that can provide information to thetelemetry unit 1606 for transmission to theelectrical stimulation system 1600. Theprogramming unit 1608 can be part of thetelemetry unit 1606 or can provide signals or information to thetelemetry unit 1606 via a wireless or wired connection. One example of a suitable programming unit is a computer operated by the user or clinician to send signals to thetelemetry unit 1606. - The signals sent to the
processor 1604 via theantenna 1618 andreceiver 1602 can be used to modify or otherwise direct the operation of the electrical stimulation system. For example, the signals may be used to modify the pulses of the electrical stimulation system such as modifying one or more of pulse duration, pulse frequency, pulse waveform, and pulse strength. The signals may also direct theelectrical stimulation system 1600 to cease operation, to start operation, to start charging the battery, or to stop charging the battery. In other embodiments, the stimulation system does not include anantenna 1618 orreceiver 1602 and theprocessor 1604 operates as programmed. - Optionally, the
electrical stimulation system 1600 may include a transmitter (not shown) coupled to theprocessor 1604 and theantenna 1618 for transmitting signals back to thetelemetry unit 1606 or another unit capable of receiving the signals. For example, theelectrical stimulation system 1600 may transmit signals indicating whether theelectrical stimulation system 1600 is operating properly or not or indicating when the battery needs to be charged or the level of charge remaining in the battery. Theprocessor 1604 may also be capable of transmitting information about the pulse characteristics so that a user or clinician can determine or verify the characteristics. - The above specification, examples and data provide a description of the manufacture and use of the composition of the invention. Since many embodiments of the invention can be made without departing from the spirit and scope of the invention, the invention also resides in the claims hereinafter appended.
Claims (20)
1. An anchoring unit for an implantable lead, the anchoring unit comprising:
a body configured and arranged for positioning along a portion of an outer surface of a lead, the body having a first end and a second end and a longitudinal axis extending therebetween, the first end being configured and arranged for placement on the lead so that the first end is positioned more distally on the lead than the second end; and
a plurality of anchoring members, each anchoring member having a proximal end and a distal end, the proximal end of each anchoring member extending from the body and the distal end of each anchoring member configured and arranged for anchoring the anchoring unit to tissue of a patient upon implantation of the anchoring unit into the patient; and
at least one connecting element coupling together at least two of the anchoring members.
2. The anchoring unit of claim 1 , wherein the at least one connecting element comprises a sheath that at least partially covers at least one of the plurality of anchoring members.
3. The anchoring unit of claim 2 , wherein the sheath completely covers at least one of the plurality of anchoring members.
4. The anchoring unit of claim 1 , wherein the at least one connecting element comprises at least one bend or articulation.
5. The anchoring unit of claim 1 , wherein at least one of the plurality of anchoring members is configured and arranged to fold flat against the outer surface of the lead when the body is coupled to the lead and the lead is inserted in a cannula of an insertion needle.
6. The anchoring unit of claim 1 , wherein at least one of the plurality of anchor mg members extends from the second end of the body.
7. The anchoring unit of claim 1 , wherein at least one of the plurality of anchoring members extends from the second end of the body such that the at least one anchoring member forms an angle with the longitudinal axis of the body that is at least ninety degrees.
8. The anchoring unit of claim 1 , wherein at least one of the plurality of anchoring members extends from the first end of the body.
9. The anchoring unit of claim 1 , wherein the distal end and the proximal end of at least one of the plurality of anchoring members have equal widths.
10. The anchoring unit of claim 1 , wherein at least one of the plurality of anchoring members tapers such that the distal end of the at least one of the plurality of anchoring members has a width that is less than a width of the proximal end of the at least one of plurality of anchoring members.
11. The anchoring unit of claim 1 , wherein the at least one connecting element couples together the distal ends of the at least two anchoring members.
12. The anchoring unit of claim 1 , wherein the at least one connecting element couples together at least two adjacent anchoring members.
13. The anchoring unit of claim 1 , wherein at least one of the plurality of connecting elements has a thickness that is substantially less than at least one of the plurality of anchoring members.
14. The anchoring unit of claim 1 , wherein tissue ingrowth forms over at least a portion of the anchoring unit during the useful lifespan of the anchoring unit.
15. A lead assembly comprising:
a lead having a distal end and a proximal end, the lead comprising
a plurality of electrodes disposed on the distal end of the lead,
a plurality of terminals disposed on the proximal end of the lead,
a plurality of conductors, each conductor electrically coupling at least one of the electrodes to at least one of the terminals; and
the anchoring unit of claim 1 ;
16. An electrical stimulating system comprising:
the lead assembly of claim 15 ;
a control module configured and arranged to electrically couple to the proximal end of the lead of the lead assembly, the control module comprising
a housing, and
an electronic subassembly disposed in the housing; and
a connector for receiving the lead of the lead assembly, the connector comprising
a connector housing defining a port at the distal end of the connector, the port configured and arranged for receiving the proximal end of the lead of the lead assembly, and
a plurality of connector contacts disposed in the connector housing, the connector contacts configured and arranged to couple to at least one of the plurality of terminals disposed on the proximal end of the lead of the lead assembly.
17. The electrical stimulating system of claim 16 , wherein the connector is disposed on the control module.
18. The electrical stimulating system of claim 16 , wherein the connector is disposed on a distal end of a lead extension.
19. The electrical stimulating system of claim 18 , wherein the lead extension has a proximal end that couples with a second connector disposed on the control module.
20. A method of stimulating patient tissue comprising:
providing the lead assembly of claim 15 ;
inserting the lead assembly into a patient such that the electrodes of the lead assembly are in proximity to the patient tissue to be stimulated;
coupling the lead assembly to a control module;
generating electrical signals using the control module; and
propagating the generated electrical signals to the electrodes of the lead assembly.
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/755,756 US20100256696A1 (en) | 2009-04-07 | 2010-04-07 | Anchoring Units For Implantable Electrical Stimulation Systems And Methods Of Making And Using |
US14/720,718 US9610435B2 (en) | 2009-04-07 | 2015-05-22 | Anchoring units for implantable electrical stimulation systems and methods of making and using |
US15/432,801 US20170151428A1 (en) | 2009-04-07 | 2017-02-14 | Anchoring units for implantable electrical stimulation systems and methods of making and using |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US16735809P | 2009-04-07 | 2009-04-07 | |
US12/755,756 US20100256696A1 (en) | 2009-04-07 | 2010-04-07 | Anchoring Units For Implantable Electrical Stimulation Systems And Methods Of Making And Using |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US14/720,718 Division US9610435B2 (en) | 2009-04-07 | 2015-05-22 | Anchoring units for implantable electrical stimulation systems and methods of making and using |
Publications (1)
Publication Number | Publication Date |
---|---|
US20100256696A1 true US20100256696A1 (en) | 2010-10-07 |
Family
ID=42826842
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US12/755,756 Abandoned US20100256696A1 (en) | 2009-04-07 | 2010-04-07 | Anchoring Units For Implantable Electrical Stimulation Systems And Methods Of Making And Using |
US14/720,718 Active US9610435B2 (en) | 2009-04-07 | 2015-05-22 | Anchoring units for implantable electrical stimulation systems and methods of making and using |
US15/432,801 Abandoned US20170151428A1 (en) | 2009-04-07 | 2017-02-14 | Anchoring units for implantable electrical stimulation systems and methods of making and using |
Family Applications After (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US14/720,718 Active US9610435B2 (en) | 2009-04-07 | 2015-05-22 | Anchoring units for implantable electrical stimulation systems and methods of making and using |
US15/432,801 Abandoned US20170151428A1 (en) | 2009-04-07 | 2017-02-14 | Anchoring units for implantable electrical stimulation systems and methods of making and using |
Country Status (1)
Country | Link |
---|---|
US (3) | US20100256696A1 (en) |
Cited By (40)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20120053665A1 (en) * | 2010-08-25 | 2012-03-01 | Medtronic, Inc. | Fixation components for implantable medical devices and associated device construction |
WO2013070875A1 (en) * | 2011-11-08 | 2013-05-16 | Nevro Corporation | Medical device contact assemblies for use with implantable leads, and associated systems and methods |
WO2014186117A1 (en) * | 2013-05-14 | 2014-11-20 | Boston Scientific Neuromodulation Corporation | Electrical stimulation leads with anchoring unit and electrode arrangement and methods of making and using |
WO2014186116A1 (en) * | 2013-05-14 | 2014-11-20 | Boston Scientific Neuromodulation Corporation | Electrical stimulation leads and systems with anchoring units and methods of making and using |
US20150025612A1 (en) * | 2013-07-22 | 2015-01-22 | Cardiac Pacemakers, Inc. | System and methods for chronic fixation of medical devices |
WO2015021189A1 (en) | 2013-08-06 | 2015-02-12 | Regenerative Sciences, Llc | Bone marrow adipose portion isolation device and methods |
WO2015134327A2 (en) | 2014-03-03 | 2015-09-11 | Boston Scientific Neuromodulation Corporation | Electrical stimulation leads with multiple anchoring units and methods of making and using |
US9180298B2 (en) | 2010-11-30 | 2015-11-10 | Nevro Corp. | Extended pain relief via high frequency spinal cord modulation, and associated systems and methods |
US20160001060A1 (en) * | 2014-07-07 | 2016-01-07 | Boston Scientific Neuromodulation Corporation | Electrical stimulation leads and systems with elongate anchoring elements and methods of making and using |
WO2016014816A1 (en) * | 2014-07-24 | 2016-01-28 | Medtronic, Inc. | Methods of shielding implantable medical leads and implantable medical lead extensions |
US9248293B2 (en) | 2009-04-22 | 2016-02-02 | Nevro Corporation | Devices for controlling high frequency spinal cord modulation for inhibiting pain, and associated systems and methods, including simplified program selection |
US9278215B2 (en) | 2011-09-08 | 2016-03-08 | Nevro Corporation | Selective high frequency spinal cord modulation for inhibiting pain, including cephalic and/or total body pain with reduced side effects, and associated systems and methods |
US9308022B2 (en) | 2012-12-10 | 2016-04-12 | Nevro Corporation | Lead insertion devices and associated systems and methods |
US9358388B2 (en) | 2010-09-30 | 2016-06-07 | Nevro Corporation | Systems and methods for detecting intrathecal penetration |
US9403013B2 (en) | 2009-01-29 | 2016-08-02 | Nevro Corporation | Systems and methods for producing asynchronous neural responses to treat pain and/or other patient conditions |
US9409019B2 (en) | 2009-07-28 | 2016-08-09 | Nevro Corporation | Linked area parameter adjustment for spinal cord stimulation and associated systems and methods |
US9427574B2 (en) | 2014-08-15 | 2016-08-30 | Axonics Modulation Technologies, Inc. | Implantable lead affixation structure for nerve stimulation to alleviate bladder dysfunction and other indication |
JP2016536069A (en) * | 2013-11-08 | 2016-11-24 | ボストン サイエンティフィック ニューロモデュレイション コーポレイション | Circuit board for implantable medical device and assembly and inspection method |
US9517338B1 (en) | 2016-01-19 | 2016-12-13 | Axonics Modulation Technologies, Inc. | Multichannel clip device and methods of use |
US9610435B2 (en) | 2009-04-07 | 2017-04-04 | Boston Scientific Neuromodulation Corporation | Anchoring units for implantable electrical stimulation systems and methods of making and using |
US9649489B2 (en) | 2014-06-02 | 2017-05-16 | Boston Scientific Neuromodulation Corporation | Electrical stimulation leads and systems with anchoring units having struts and methods of making and using |
US9669210B2 (en) | 2014-04-22 | 2017-06-06 | Boston Scientific Neuromodulation Corporation | Electrical stimulation leads and systems with folding anchoring units and methods of making and using |
US9789321B2 (en) | 2015-04-03 | 2017-10-17 | Nevro Corp. | Couplings for implanted leads and external stimulators, and associated systems and methods |
US9833614B1 (en) | 2012-06-22 | 2017-12-05 | Nevro Corp. | Autonomic nervous system control via high frequency spinal cord modulation, and associated systems and methods |
US9895539B1 (en) | 2013-06-10 | 2018-02-20 | Nevro Corp. | Methods and systems for disease treatment using electrical stimulation |
US10149978B1 (en) | 2013-11-07 | 2018-12-11 | Nevro Corp. | Spinal cord modulation for inhibiting pain via short pulse width waveforms, and associated systems and methods |
US10195423B2 (en) | 2016-01-19 | 2019-02-05 | Axonics Modulation Technologies, Inc. | Multichannel clip device and methods of use |
US20190054289A1 (en) * | 2017-08-17 | 2019-02-21 | Cardiac Pacemakers, Inc. | Retention mechanism for an implantable lead |
US10493275B2 (en) | 2009-04-22 | 2019-12-03 | Nevro Corp. | Spinal cord modulation for inducing paresthetic and anesthetic effects, and associated systems and methods |
WO2020023487A1 (en) * | 2018-07-23 | 2020-01-30 | Cardiac Pacemakers, Inc. | Retention mechanism for an implantable lead |
US10561835B2 (en) | 2006-10-31 | 2020-02-18 | Medtronic, Inc. | Implantable medical lead with threaded fixation |
US10888697B2 (en) | 2017-08-18 | 2021-01-12 | Cardiac Pacemakers, Inc. | Fixation mechanism for an implantable lead |
US10980999B2 (en) | 2017-03-09 | 2021-04-20 | Nevro Corp. | Paddle leads and delivery tools, and associated systems and methods |
US11110283B2 (en) | 2018-02-22 | 2021-09-07 | Axonics, Inc. | Neurostimulation leads for trial nerve stimulation and methods of use |
US11147964B2 (en) | 2018-04-23 | 2021-10-19 | Cardiac Pacemakers, Inc. | Subcutaneous lead fixation member |
US11219775B2 (en) | 2018-05-01 | 2022-01-11 | Cardiac Pacemakers, Inc. | Retention mechanism for an implantable lead |
US11318310B1 (en) | 2015-10-26 | 2022-05-03 | Nevro Corp. | Neuromodulation for altering autonomic functions, and associated systems and methods |
US11420045B2 (en) | 2018-03-29 | 2022-08-23 | Nevro Corp. | Leads having sidewall openings, and associated systems and methods |
US11590352B2 (en) | 2019-01-29 | 2023-02-28 | Nevro Corp. | Ramped therapeutic signals for modulating inhibitory interneurons, and associated systems and methods |
US11596798B2 (en) | 2016-01-25 | 2023-03-07 | Nevro Corp | Treatment of congestive heart failure with electrical stimulation, and associated systems and methods |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11351386B2 (en) | 2017-08-17 | 2022-06-07 | Cardiac Pacemakers, Inc. | Single incision subcutaneous implantable defibrillation system |
US10751526B2 (en) | 2017-10-25 | 2020-08-25 | Cardiac Pacemakers, Inc. | Subcutaneous lead implantation |
US11389647B2 (en) | 2020-02-03 | 2022-07-19 | Nevro Corp. | Neurological stimulation lead anchors and associated tools, and methods |
Citations (15)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4706682A (en) * | 1985-08-21 | 1987-11-17 | Minnesota Mining And Manufacturing Company | External ear canal electrode to be placed proximate the tympanic membrane |
US20050288722A1 (en) * | 2002-09-26 | 2005-12-29 | Eigler Neal L | Implantable pressure transducer system optimized for anchoring and positioning |
US6999819B2 (en) * | 2001-08-31 | 2006-02-14 | Medtronic, Inc. | Implantable medical electrical stimulation lead fixation method and apparatus |
US7328068B2 (en) * | 2003-03-31 | 2008-02-05 | Medtronic, Inc. | Method, system and device for treating disorders of the pelvic floor by means of electrical stimulation of the pudendal and associated nerves, and the optional delivery of drugs in association therewith |
US7343202B2 (en) * | 2004-02-12 | 2008-03-11 | Ndi Medical, Llc. | Method for affecting urinary function with electrode implantation in adipose tissue |
US7369894B2 (en) * | 2002-09-06 | 2008-05-06 | Medtronic, Inc. | Method, system and device for treating disorders of the pelvic floor by electrical stimulation of the sacral and/or pudendal nerves |
US20080183253A1 (en) * | 2007-01-30 | 2008-07-31 | Cardiac Pacemakers, Inc. | Neurostimulating lead having a stent-like anchor |
US20090054949A1 (en) * | 2007-08-22 | 2009-02-26 | Medtronic, Inc. | Lead body constructions for implantable medical electrical leads |
US7565198B2 (en) * | 2004-02-12 | 2009-07-21 | Medtronic Urinary Solutions, Inc. | Systems and methods for bilateral stimulation of left and right branches of the dorsal genital nerves to treat dysfunctions, such as urinary incontinence |
US20090248095A1 (en) * | 2008-04-01 | 2009-10-01 | Boston Scientific Neuromodulation Corporation | Anchoring units for leads of implantable electric stimulation systems and methods of making and using |
US20090254151A1 (en) * | 2008-04-02 | 2009-10-08 | Boston Scientific Neuromodulation Corporation | Lead anchor for implantable devices and methods of manufacture and use |
US20100168806A1 (en) * | 2006-11-30 | 2010-07-01 | Anna Norlin-Weissenrieder | Device and method for treating cardiac tissue of a heart of a patient with therapeutic light using photobiomodulation |
US7881783B2 (en) * | 2006-04-28 | 2011-02-01 | Medtronics, Inc. | Implantable medical electrical stimulation lead, such as a PNE lead, and method of use |
US20120053665A1 (en) * | 2010-08-25 | 2012-03-01 | Medtronic, Inc. | Fixation components for implantable medical devices and associated device construction |
US20130066411A1 (en) * | 2011-09-08 | 2013-03-14 | James R. Thacker | Selective high frequency spinal cord modulation for inhibiting pain, including cephalic and/or total body pain with reduced side effects, and associated systems and methods |
Family Cites Families (101)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3814104A (en) | 1971-07-05 | 1974-06-04 | W Irnich | Pacemaker-electrode |
US3754555A (en) | 1971-10-05 | 1973-08-28 | G Schmitt | Controllable barbed intracardial electrode |
US4112952A (en) | 1977-02-11 | 1978-09-12 | The United States Of America As Represented By The Secretary Of Health, Education And Welfare | Electrode for artificial pacemaker |
DE2843096A1 (en) | 1978-09-30 | 1980-04-10 | Biotronik Mess & Therapieg | PACEMAKER ELECTRODE FOR TRANSVENOUS APPLICATION |
US4301815A (en) * | 1980-01-23 | 1981-11-24 | Telectronics Pty. Limited | Trailing tine electrode lead |
US4378023A (en) | 1980-05-29 | 1983-03-29 | Trabucco Hector O | Percutaneous insertable electrode device for the transitory or permanent stimulation of the heart or other organs and a method for implanting it |
US4519404A (en) * | 1983-09-28 | 1985-05-28 | Fleischhacker John J | Endocardial electrode lead with conical fixation mechanism |
EP0261582B1 (en) | 1986-09-23 | 1992-12-16 | Siemens-Elema AB | Heart pacemaker electrode |
US4796643A (en) * | 1986-09-30 | 1989-01-10 | Telectronics N.V. | Medical electrode leads |
US4883070A (en) * | 1988-03-02 | 1989-11-28 | Hanson Ralph E | Endocardial pacing lead |
US5052407A (en) | 1988-04-14 | 1991-10-01 | Mieczyslaw Mirowski | Cardiac defibrillation/cardioversion spiral patch electrode |
US4989617A (en) * | 1989-07-14 | 1991-02-05 | Case Western Reserve University | Intramuscular electrode for neuromuscular stimulation system |
FR2690626B1 (en) | 1992-04-30 | 1998-10-16 | Ela Medical Sa | PROBE FOR HEART STIMULATOR. |
US5314462A (en) | 1992-05-27 | 1994-05-24 | Cardiac Pacemakers, Inc. | Positive fixation device |
US5325870A (en) | 1992-12-16 | 1994-07-05 | Angeion Corporation | Multiplexed defibrillation electrode apparatus |
WO1994027670A1 (en) | 1993-06-02 | 1994-12-08 | Cardiac Pathways Corporation | Catheter having tip with fixation means |
US5492119A (en) | 1993-12-22 | 1996-02-20 | Heart Rhythm Technologies, Inc. | Catheter tip stabilizing apparatus |
SE9402775D0 (en) | 1994-08-19 | 1994-08-19 | Siemens Elema Ab | Electrode device for intracardiac stimulation of the heart tissue and / or sensing of the heart signals of a patient |
US5545206A (en) * | 1994-12-22 | 1996-08-13 | Ventritex, Inc. | Low profile lead with automatic tine activation |
US5571162A (en) | 1995-06-07 | 1996-11-05 | Intermedics, Inc. | Transvenous defibrillation lead with side hooks |
US5674273A (en) | 1995-10-17 | 1997-10-07 | Pacesetter, Inc. | Implantable pacing lead with crush resistant, protective sleeve |
US5891137A (en) | 1997-05-21 | 1999-04-06 | Irvine Biomedical, Inc. | Catheter system having a tip with fixation means |
US5871532A (en) | 1997-05-22 | 1999-02-16 | Sulzer Intermedics Inc. | Epicardial lead for minimally invasive implantation |
US6249708B1 (en) | 1997-08-26 | 2001-06-19 | Angeion Corporation | Fluted channel construction for a multi-conductor catheter lead |
US5922014A (en) | 1997-09-02 | 1999-07-13 | Medtronic, Inc. | Single pass lead and method of use |
US6345198B1 (en) | 1998-01-23 | 2002-02-05 | Pacesetter, Inc. | Implantable stimulation system for providing dual bipolar sensing using an electrode positioned in proximity to the tricuspid valve and programmable polarity |
US5948014A (en) | 1998-01-23 | 1999-09-07 | Pacesetter, Inc. | Implantable stimulation system having a single-pass, tripolar lead and programmable polarity |
US5957966A (en) | 1998-02-18 | 1999-09-28 | Intermedics Inc. | Implantable cardiac lead with multiple shape memory polymer structures |
US6093185A (en) | 1998-03-05 | 2000-07-25 | Scimed Life Systems, Inc. | Expandable PMR device and method |
WO2000000251A1 (en) | 1998-06-26 | 2000-01-06 | Advanced Bionics Corporation | Programmable current output stimulus stage for implantable device |
US6393325B1 (en) | 1999-01-07 | 2002-05-21 | Advanced Bionics Corporation | Directional programming for implantable electrode arrays |
US6626899B2 (en) * | 1999-06-25 | 2003-09-30 | Nidus Medical, Llc | Apparatus and methods for treating tissue |
AU6953300A (en) * | 1999-07-07 | 2001-01-22 | Cardiac Pacemakers, Inc. | Endocardial electrode assembly having conductive fixation features |
US6516227B1 (en) | 1999-07-27 | 2003-02-04 | Advanced Bionics Corporation | Rechargeable spinal cord stimulator system |
US7175644B2 (en) * | 2001-02-14 | 2007-02-13 | Broncus Technologies, Inc. | Devices and methods for maintaining collateral channels in tissue |
US7949395B2 (en) * | 1999-10-01 | 2011-05-24 | Boston Scientific Neuromodulation Corporation | Implantable microdevice with extended lead and remote electrode |
US20030093104A1 (en) * | 1999-10-29 | 2003-05-15 | Bonner Matthew D. | Methods and apparatus for providing intra-pericardial access |
US6609029B1 (en) | 2000-02-04 | 2003-08-19 | Advanced Bionics Corporation | Clip lock mechanism for retaining lead |
US6741892B1 (en) | 2000-03-10 | 2004-05-25 | Advanced Bionics Corporation | Movable contact locking mechanism for spinal cord stimulator lead connector |
EP1284782B1 (en) * | 2000-05-17 | 2005-07-20 | Cook Vascular Incorporated | Lead removal apparatus |
US20020156058A1 (en) | 2000-08-17 | 2002-10-24 | Borkan William N. | Medical methods using catheters |
SE0004765D0 (en) | 2000-12-20 | 2000-12-20 | St Jude Medical | An electrode head fixation arrangement |
EP1370186B1 (en) | 2001-02-28 | 2006-01-18 | Rex Medical, L.P. | Apparatus for delivering ablation fluid to treat neoplasms |
US20060069429A1 (en) * | 2001-04-24 | 2006-03-30 | Spence Paul A | Tissue fastening systems and methods utilizing magnetic guidance |
US20020188170A1 (en) * | 2001-04-27 | 2002-12-12 | Santamore William P. | Prevention of myocardial infarction induced ventricular expansion and remodeling |
US7311731B2 (en) * | 2001-04-27 | 2007-12-25 | Richard C. Satterfield | Prevention of myocardial infarction induced ventricular expansion and remodeling |
US20030130713A1 (en) | 2001-05-21 | 2003-07-10 | Stewart Mark T. | Trans-septal catheter with retention mechanism |
US6671544B2 (en) | 2001-06-28 | 2003-12-30 | Medtronic, Inc. | Low impedance implantable extension for a neurological electrical stimulator |
US8364278B2 (en) | 2002-01-29 | 2013-01-29 | Boston Scientific Neuromodulation Corporation | Lead assembly for implantable microstimulator |
US7463934B2 (en) * | 2002-04-12 | 2008-12-09 | Medtronic, Inc. | Implantable medical device with captivation fixation |
EP1517725B1 (en) | 2002-06-28 | 2015-09-09 | Boston Scientific Neuromodulation Corporation | Microstimulator having self-contained power source and bi-directional telemetry system |
US7107105B2 (en) | 2002-09-24 | 2006-09-12 | Medtronic, Inc. | Deployable medical lead fixation system and method |
JP2006500991A (en) | 2002-09-26 | 2006-01-12 | サバコア インコーポレイテッド | Cardiovascular fixation device and method of placing the same |
US7130700B2 (en) | 2002-11-19 | 2006-10-31 | Medtronic, Inc. | Multilumen body for an implantable medical device |
US7493175B2 (en) | 2003-04-11 | 2009-02-17 | Cardiac Pacemakers, Inc. | Subcutaneous lead with tined fixation |
US7184842B2 (en) | 2003-08-08 | 2007-02-27 | Medtronic, Inc. | Medical electrical lead anchoring |
US7190993B2 (en) * | 2003-11-04 | 2007-03-13 | Medtronic, Inc. | Implantable medical device having optical fiber for sensing electrical activity |
WO2005110280A2 (en) * | 2004-05-07 | 2005-11-24 | Valentx, Inc. | Devices and methods for attaching an endolumenal gastrointestinal implant |
EP1799129B1 (en) * | 2004-10-15 | 2020-11-25 | Baxano, Inc. | Devices for tissue removal |
US7758594B2 (en) * | 2005-05-20 | 2010-07-20 | Neotract, Inc. | Devices, systems and methods for treating benign prostatic hyperplasia and other conditions |
US7927282B2 (en) | 2005-07-19 | 2011-04-19 | Medtronic, Inc. | System and method of determining cardiac pressure |
JP2009504331A (en) | 2005-08-15 | 2009-02-05 | シネコー・エルエルシー | Fixing and removing leads |
US20070049980A1 (en) | 2005-08-30 | 2007-03-01 | Zielinski Todd M | Trans-septal pressure sensor |
US7761165B1 (en) | 2005-09-29 | 2010-07-20 | Boston Scientific Neuromodulation Corporation | Implantable stimulator with integrated plastic housing/metal contacts and manufacture and use |
US8700178B2 (en) | 2005-12-27 | 2014-04-15 | Boston Scientific Neuromodulation Corporation | Stimulator leads and methods for lead fabrication |
US7672734B2 (en) | 2005-12-27 | 2010-03-02 | Boston Scientific Neuromodulation Corporation | Non-linear electrode array |
US7244150B1 (en) | 2006-01-09 | 2007-07-17 | Advanced Bionics Corporation | Connector and methods of fabrication |
US8532789B2 (en) | 2006-02-28 | 2013-09-10 | Medtronic, Inc. | Subcutaneous lead fixation mechanisms |
US8175710B2 (en) | 2006-03-14 | 2012-05-08 | Boston Scientific Neuromodulation Corporation | Stimulator system with electrode array and the method of making the same |
US7974706B2 (en) | 2006-03-30 | 2011-07-05 | Boston Scientific Neuromodulation Corporation | Electrode contact configurations for cuff leads |
US20070293923A1 (en) | 2006-06-15 | 2007-12-20 | Cardiac Pacemakers, Inc. | Lead with orientation feature |
EP2040791A4 (en) * | 2006-06-21 | 2011-05-04 | Intrapace Inc | Endoscopic device delivery system |
US20090012592A1 (en) * | 2006-07-10 | 2009-01-08 | Ams Research Corporation | Tissue anchor |
US7899550B1 (en) | 2006-08-21 | 2011-03-01 | Pacesetter, Inc. | Apparatus and method for transseptal fixation |
CA2661191C (en) * | 2006-08-23 | 2014-12-02 | Svip 2 Llc | Devices and methods for altering eating behavior |
US8224450B2 (en) | 2006-09-18 | 2012-07-17 | Boston Scientific Neuromodulation Corporation | Feed through interconnect assembly for an implantable stimulation system and methods of making and using |
US8417343B2 (en) * | 2006-10-13 | 2013-04-09 | Apnex Medical, Inc. | Obstructive sleep apnea treatment devices, systems and methods |
US8688238B2 (en) | 2006-10-31 | 2014-04-01 | Medtronic, Inc. | Implantable medical elongated member including fixation elements along an interior surface |
US20080103572A1 (en) * | 2006-10-31 | 2008-05-01 | Medtronic, Inc. | Implantable medical lead with threaded fixation |
WO2010004546A1 (en) * | 2008-06-16 | 2010-01-14 | Valtech Cardio, Ltd. | Annuloplasty devices and methods of delivery therefor |
US9314618B2 (en) * | 2006-12-06 | 2016-04-19 | Spinal Modulation, Inc. | Implantable flexible circuit leads and methods of use |
WO2008070808A2 (en) * | 2006-12-06 | 2008-06-12 | Spinal Modulation, Inc. | Expandable stimulation leads and methods of use |
MX2009007289A (en) * | 2007-01-03 | 2009-09-09 | Mitralsolutions Inc | Implantable devices for controlling the size and shape of an anatomical structure or lumen. |
US7643886B2 (en) | 2007-01-25 | 2010-01-05 | Cardiac Pacemakers, Inc. | Hydraulic actuation of lead fixation member |
US7835801B1 (en) | 2007-02-13 | 2010-11-16 | Pacesetter, Inc. | Electric lead with controllable fixation |
WO2008106338A2 (en) * | 2007-02-28 | 2008-09-04 | Medtronic, Inc. | Implantable medical device system with fixation member |
US8443808B2 (en) * | 2007-03-19 | 2013-05-21 | Hologic, Inc. | Methods and apparatus for occlusion of body lumens |
WO2008127910A1 (en) | 2007-04-13 | 2008-10-23 | Boston Scientific Scimed, Inc. | Radiofrequency ablation device |
US8634932B1 (en) * | 2008-07-21 | 2014-01-21 | Greatbatch Ltd. | Minimally invasive methods for implanting a sacral stimulation lead |
DE102008040773A1 (en) | 2008-07-28 | 2010-02-04 | Biotronik Crm Patent Ag | Implantable catheter or electrode lead |
US20100256696A1 (en) | 2009-04-07 | 2010-10-07 | Boston Scientific Neuromodulation Corporation | Anchoring Units For Implantable Electrical Stimulation Systems And Methods Of Making And Using |
US8478431B2 (en) | 2010-04-13 | 2013-07-02 | Medtronic, Inc. | Slidable fixation device for securing a medical implant |
WO2012047408A1 (en) | 2010-09-28 | 2012-04-12 | The Board Of Trustees Of The Leland Stanford Junior University | Device and method for positioning an electrode in tissue |
US10328253B2 (en) | 2011-11-30 | 2019-06-25 | Medtronic, Inc. | Medical electrical stimulation lead including expandable coiled fixation element |
US8718790B2 (en) * | 2012-05-25 | 2014-05-06 | Boston Scientific Neuromodulation Corporation | Systems and methods for providing electrical stimulation of multiple dorsal root ganglia with a single lead |
US20140330287A1 (en) | 2013-05-06 | 2014-11-06 | Medtronic, Inc. | Devices and techniques for anchoring an implantable medical device |
US10406353B2 (en) | 2013-05-14 | 2019-09-10 | Boston Scientific Neuromodulation Corporation | Electrical stimulation leads with anchoring unit and electrode arrangement and methods of making and using |
EP2996762A1 (en) | 2013-05-14 | 2016-03-23 | Boston Scientific Neuromodulation Corporation | Electrical stimulation leads and systems with anchoring units and methods of making and using |
US9119959B2 (en) | 2013-07-31 | 2015-09-01 | Medtronic, Inc. | Tine fixation components for implantable medical devices |
US10179236B2 (en) | 2013-08-16 | 2019-01-15 | Cardiac Pacemakers, Inc. | Leadless cardiac pacing devices |
US9981121B2 (en) | 2014-04-28 | 2018-05-29 | Medtronic, Inc. | Implantable medical devices, systems and components thereof |
-
2010
- 2010-04-07 US US12/755,756 patent/US20100256696A1/en not_active Abandoned
-
2015
- 2015-05-22 US US14/720,718 patent/US9610435B2/en active Active
-
2017
- 2017-02-14 US US15/432,801 patent/US20170151428A1/en not_active Abandoned
Patent Citations (15)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4706682A (en) * | 1985-08-21 | 1987-11-17 | Minnesota Mining And Manufacturing Company | External ear canal electrode to be placed proximate the tympanic membrane |
US6999819B2 (en) * | 2001-08-31 | 2006-02-14 | Medtronic, Inc. | Implantable medical electrical stimulation lead fixation method and apparatus |
US7369894B2 (en) * | 2002-09-06 | 2008-05-06 | Medtronic, Inc. | Method, system and device for treating disorders of the pelvic floor by electrical stimulation of the sacral and/or pudendal nerves |
US20050288722A1 (en) * | 2002-09-26 | 2005-12-29 | Eigler Neal L | Implantable pressure transducer system optimized for anchoring and positioning |
US7328068B2 (en) * | 2003-03-31 | 2008-02-05 | Medtronic, Inc. | Method, system and device for treating disorders of the pelvic floor by means of electrical stimulation of the pudendal and associated nerves, and the optional delivery of drugs in association therewith |
US7343202B2 (en) * | 2004-02-12 | 2008-03-11 | Ndi Medical, Llc. | Method for affecting urinary function with electrode implantation in adipose tissue |
US7565198B2 (en) * | 2004-02-12 | 2009-07-21 | Medtronic Urinary Solutions, Inc. | Systems and methods for bilateral stimulation of left and right branches of the dorsal genital nerves to treat dysfunctions, such as urinary incontinence |
US7881783B2 (en) * | 2006-04-28 | 2011-02-01 | Medtronics, Inc. | Implantable medical electrical stimulation lead, such as a PNE lead, and method of use |
US20100168806A1 (en) * | 2006-11-30 | 2010-07-01 | Anna Norlin-Weissenrieder | Device and method for treating cardiac tissue of a heart of a patient with therapeutic light using photobiomodulation |
US20080183253A1 (en) * | 2007-01-30 | 2008-07-31 | Cardiac Pacemakers, Inc. | Neurostimulating lead having a stent-like anchor |
US20090054949A1 (en) * | 2007-08-22 | 2009-02-26 | Medtronic, Inc. | Lead body constructions for implantable medical electrical leads |
US20090248095A1 (en) * | 2008-04-01 | 2009-10-01 | Boston Scientific Neuromodulation Corporation | Anchoring units for leads of implantable electric stimulation systems and methods of making and using |
US20090254151A1 (en) * | 2008-04-02 | 2009-10-08 | Boston Scientific Neuromodulation Corporation | Lead anchor for implantable devices and methods of manufacture and use |
US20120053665A1 (en) * | 2010-08-25 | 2012-03-01 | Medtronic, Inc. | Fixation components for implantable medical devices and associated device construction |
US20130066411A1 (en) * | 2011-09-08 | 2013-03-14 | James R. Thacker | Selective high frequency spinal cord modulation for inhibiting pain, including cephalic and/or total body pain with reduced side effects, and associated systems and methods |
Cited By (108)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10561835B2 (en) | 2006-10-31 | 2020-02-18 | Medtronic, Inc. | Implantable medical lead with threaded fixation |
US9403013B2 (en) | 2009-01-29 | 2016-08-02 | Nevro Corporation | Systems and methods for producing asynchronous neural responses to treat pain and/or other patient conditions |
US11883670B2 (en) | 2009-01-29 | 2024-01-30 | Nevro Corp. | Systems and methods for producing asynchronous neural responses to treat pain and/or other patient conditions |
US10918867B2 (en) | 2009-01-29 | 2021-02-16 | Nevro Corp. | Systems and methods for producing asynchronous neural responses to treat pain and/or other patient conditions |
US10179241B2 (en) | 2009-01-29 | 2019-01-15 | Nevro Corp. | Systems and methods for producing asynchronous neural responses to treat pain and/or other patient conditions |
US10173065B2 (en) | 2009-01-29 | 2019-01-08 | Nevro Corp. | Systems and methods for producing asynchronous neural responses to treat pain and/or other patient conditions |
US9610435B2 (en) | 2009-04-07 | 2017-04-04 | Boston Scientific Neuromodulation Corporation | Anchoring units for implantable electrical stimulation systems and methods of making and using |
US9333360B2 (en) | 2009-04-22 | 2016-05-10 | Nevro Corporation | Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods |
US9480842B2 (en) | 2009-04-22 | 2016-11-01 | Nevro Corporation | Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods |
US10245433B2 (en) | 2009-04-22 | 2019-04-02 | Nevro Corp. | Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods |
US10226626B2 (en) | 2009-04-22 | 2019-03-12 | Nevro Corp. | Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods |
US10220208B2 (en) | 2009-04-22 | 2019-03-05 | Nevro Corp. | Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods |
US9248293B2 (en) | 2009-04-22 | 2016-02-02 | Nevro Corporation | Devices for controlling high frequency spinal cord modulation for inhibiting pain, and associated systems and methods, including simplified program selection |
US10413729B2 (en) | 2009-04-22 | 2019-09-17 | Nevro Corp. | Devices for controlling high frequency spinal cord modulation for inhibiting pain, and associated systems and methods, including simplified contact selection |
US10463857B2 (en) | 2009-04-22 | 2019-11-05 | Nevro Corp. | Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods |
US10195433B2 (en) | 2009-04-22 | 2019-02-05 | Nevro Corp. | Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods |
US10471258B2 (en) | 2009-04-22 | 2019-11-12 | Nevro Corp. | Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods |
US10493275B2 (en) | 2009-04-22 | 2019-12-03 | Nevro Corp. | Spinal cord modulation for inducing paresthetic and anesthetic effects, and associated systems and methods |
US9993645B2 (en) | 2009-04-22 | 2018-06-12 | Nevro Corp. | Devices for controlling high frequency spinal cord modulation for inhibiting pain, and associated systems and methods, including simplified program selection |
US9327126B2 (en) | 2009-04-22 | 2016-05-03 | Nevro Corporation | Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods |
US10603494B2 (en) | 2009-04-22 | 2020-03-31 | Nevro Corp. | Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods |
US9327127B2 (en) | 2009-04-22 | 2016-05-03 | Nevro Corporation | Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods |
US9327125B2 (en) | 2009-04-22 | 2016-05-03 | Nevro Corporation | Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods |
US9333358B2 (en) | 2009-04-22 | 2016-05-10 | Nevro Corporation | Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods |
US9333359B2 (en) | 2009-04-22 | 2016-05-10 | Nevro Corporation | Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods |
US11229793B2 (en) | 2009-04-22 | 2022-01-25 | Nevro Corp. | Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods |
US9333357B2 (en) | 2009-04-22 | 2016-05-10 | Nevro Corporation | Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods |
US9592388B2 (en) | 2009-04-22 | 2017-03-14 | Nevro Corp. | Devices for controlling high frequency spinal cord modulation for inhibiting pain, and associated systems and methods, including simplified contact selection |
US11229792B2 (en) | 2009-04-22 | 2022-01-25 | Nevro Corp. | Spinal cord modulation for inducing paresthetic and anesthetic effects, and associated systems and methods |
US11786731B2 (en) | 2009-04-22 | 2023-10-17 | Nevro Corp. | Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods |
US11759638B2 (en) | 2009-04-22 | 2023-09-19 | Nevro Corp. | Spinal cord modulation for inducing paresthetic and anesthetic effects, and associated systems and methods |
US10220209B2 (en) | 2009-04-22 | 2019-03-05 | Nevro Corp. | Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods |
US9387327B2 (en) | 2009-04-22 | 2016-07-12 | Nevro Corporation | Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods |
US9409019B2 (en) | 2009-07-28 | 2016-08-09 | Nevro Corporation | Linked area parameter adjustment for spinal cord stimulation and associated systems and methods |
US20120053665A1 (en) * | 2010-08-25 | 2012-03-01 | Medtronic, Inc. | Fixation components for implantable medical devices and associated device construction |
US8948882B2 (en) * | 2010-08-25 | 2015-02-03 | Medtronic, Inc. | Fixation components for implantable medical devices and associated device construction |
US10279183B2 (en) | 2010-09-30 | 2019-05-07 | Nevro Corp. | Systems and methods for detecting intrathecal penetration |
US9358388B2 (en) | 2010-09-30 | 2016-06-07 | Nevro Corporation | Systems and methods for detecting intrathecal penetration |
US10258796B2 (en) | 2010-11-30 | 2019-04-16 | Nevro Corp. | Extended pain relief via high frequency spinal cord modulation, and associated systems and methods |
US9180298B2 (en) | 2010-11-30 | 2015-11-10 | Nevro Corp. | Extended pain relief via high frequency spinal cord modulation, and associated systems and methods |
US11298539B2 (en) | 2011-09-08 | 2022-04-12 | Nevro Corp. | Selective high frequency spinal cord modulation for inhibiting pain, including cephalic and/or total body pain with reduced side effects, and associated systems and methods |
US9295839B2 (en) | 2011-09-08 | 2016-03-29 | Nevro Corporation | Selective high frequency spinal cord modulation for inhibiting pain, including cephalic and/or total body pain with reduced side effects, and associated systems and methods |
US9283388B2 (en) | 2011-09-08 | 2016-03-15 | Nevro Corporation | Selective high frequency spinal cord modulation for inhibiting pain, including cephalic and/or total body pain with reduced side effects, and associated systems and methods |
US10493277B2 (en) | 2011-09-08 | 2019-12-03 | Nevro Corp. | Selective high frequency spinal cord modulation for inhibiting pain, including cephalic and/or total body pain with reduced side effects, and associated systems and methods |
US11883663B2 (en) | 2011-09-08 | 2024-01-30 | Nevro Corp. | Selective high frequency spinal cord modulation for inhibiting pain, including cephalic and/or total body pain with reduced side effects, and associated systems and methods |
US9327121B2 (en) | 2011-09-08 | 2016-05-03 | Nevro Corporation | Selective high frequency spinal cord modulation for inhibiting pain, including cephalic and/or total body pain with reduced side effects, and associated systems and methods |
US9278215B2 (en) | 2011-09-08 | 2016-03-08 | Nevro Corporation | Selective high frequency spinal cord modulation for inhibiting pain, including cephalic and/or total body pain with reduced side effects, and associated systems and methods |
US9283387B2 (en) | 2011-09-08 | 2016-03-15 | Nevro Corporation | Selective high frequency spinal cord modulation for inhibiting pain, including cephalic and/or total body pain with reduced side effects, and associated systems and methods |
WO2013070875A1 (en) * | 2011-11-08 | 2013-05-16 | Nevro Corporation | Medical device contact assemblies for use with implantable leads, and associated systems and methods |
US9833614B1 (en) | 2012-06-22 | 2017-12-05 | Nevro Corp. | Autonomic nervous system control via high frequency spinal cord modulation, and associated systems and methods |
US11247057B1 (en) | 2012-06-22 | 2022-02-15 | Nevro Corp. | Autonomic nervous system control via high frequency spinal cord modulation, and associated systems and methods |
US10328256B1 (en) | 2012-06-22 | 2019-06-25 | Nevro Corp. | Autonomic nervous system control via high frequency spinal cord modulation, and associated systems and methods |
US10213229B2 (en) | 2012-12-10 | 2019-02-26 | Nevro Corp. | Lead insertion devices and associated systems and methods |
US9308022B2 (en) | 2012-12-10 | 2016-04-12 | Nevro Corporation | Lead insertion devices and associated systems and methods |
US11103280B2 (en) | 2012-12-10 | 2021-08-31 | Nevro Corp. | Lead insertion devices and associated systems and methods |
CN105392522A (en) * | 2013-05-14 | 2016-03-09 | 波士顿科学神经调制公司 | Electrical stimulation leads with anchoring unit and electrode arrangement and methods of making and using |
JP2016518219A (en) * | 2013-05-14 | 2016-06-23 | ボストン サイエンティフィック ニューロモデュレイション コーポレイション | Electrical stimulation lead with locking unit and electrode arrangement and method of making and using |
WO2014186116A1 (en) * | 2013-05-14 | 2014-11-20 | Boston Scientific Neuromodulation Corporation | Electrical stimulation leads and systems with anchoring units and methods of making and using |
WO2014186117A1 (en) * | 2013-05-14 | 2014-11-20 | Boston Scientific Neuromodulation Corporation | Electrical stimulation leads with anchoring unit and electrode arrangement and methods of making and using |
AU2014265848B2 (en) * | 2013-05-14 | 2017-01-19 | Boston Scientific Neuromodulation Corporation | Electrical stimulation leads and systems with anchoring units and methods of making and using |
US10406353B2 (en) | 2013-05-14 | 2019-09-10 | Boston Scientific Neuromodulation Corporation | Electrical stimulation leads with anchoring unit and electrode arrangement and methods of making and using |
JP2016518218A (en) * | 2013-05-14 | 2016-06-23 | ボストン サイエンティフィック ニューロモデュレイション コーポレイション | Electrical stimulation lead and system with locking unit and method of making and using |
US9895539B1 (en) | 2013-06-10 | 2018-02-20 | Nevro Corp. | Methods and systems for disease treatment using electrical stimulation |
US10751536B1 (en) | 2013-06-10 | 2020-08-25 | Nevro Corp. | Methods and systems for disease treatment using electrical stimulation |
US20150025612A1 (en) * | 2013-07-22 | 2015-01-22 | Cardiac Pacemakers, Inc. | System and methods for chronic fixation of medical devices |
US9333342B2 (en) * | 2013-07-22 | 2016-05-10 | Cardiac Pacemakers, Inc. | System and methods for chronic fixation of medical devices |
WO2015021189A1 (en) | 2013-08-06 | 2015-02-12 | Regenerative Sciences, Llc | Bone marrow adipose portion isolation device and methods |
US10149978B1 (en) | 2013-11-07 | 2018-12-11 | Nevro Corp. | Spinal cord modulation for inhibiting pain via short pulse width waveforms, and associated systems and methods |
US10556112B1 (en) | 2013-11-07 | 2020-02-11 | Nevro Corp. | Spinal cord modulation for inhibiting pain via short pulse width waveforms, and associated systems and methods |
US10569089B1 (en) | 2013-11-07 | 2020-02-25 | Nevro Corp. | Spinal cord modulation for inhibiting pain via short pulse width waveforms, and associated systems and methods |
US10576286B1 (en) | 2013-11-07 | 2020-03-03 | Nevro Corp. | Spinal cord modulation for inhibiting pain via short pulse width waveforms, and associated systems and methods |
JP2016536069A (en) * | 2013-11-08 | 2016-11-24 | ボストン サイエンティフィック ニューロモデュレイション コーポレイション | Circuit board for implantable medical device and assembly and inspection method |
US9623256B2 (en) | 2013-11-08 | 2017-04-18 | Boston Scientific Neuromodulation Corporation | Method of fabricating and testing a circuit board |
WO2015134327A3 (en) * | 2014-03-03 | 2015-10-15 | Boston Scientific Neuromodulation Corporation | Electrical stimulation lead with at least one anchoring unit comprising a wide portion |
WO2015134327A2 (en) | 2014-03-03 | 2015-09-11 | Boston Scientific Neuromodulation Corporation | Electrical stimulation leads with multiple anchoring units and methods of making and using |
US9364658B2 (en) | 2014-03-03 | 2016-06-14 | Boston Scientific Neuromodulation Corporation | Electrical stimulation leads with multiple anchoring units and methods of making and using |
US9669210B2 (en) | 2014-04-22 | 2017-06-06 | Boston Scientific Neuromodulation Corporation | Electrical stimulation leads and systems with folding anchoring units and methods of making and using |
US9649489B2 (en) | 2014-06-02 | 2017-05-16 | Boston Scientific Neuromodulation Corporation | Electrical stimulation leads and systems with anchoring units having struts and methods of making and using |
US20160001060A1 (en) * | 2014-07-07 | 2016-01-07 | Boston Scientific Neuromodulation Corporation | Electrical stimulation leads and systems with elongate anchoring elements and methods of making and using |
US9533141B2 (en) * | 2014-07-07 | 2017-01-03 | Boston Scientific Neuromodulation Corporation | Electrical stimulation leads and systems with elongate anchoring elements |
US11452877B2 (en) * | 2014-07-24 | 2022-09-27 | Medtronic, Inc. | Methods of shielding implantable medical leads and implantable medical lead extensions |
WO2016014816A1 (en) * | 2014-07-24 | 2016-01-28 | Medtronic, Inc. | Methods of shielding implantable medical leads and implantable medical lead extensions |
US10155111B2 (en) | 2014-07-24 | 2018-12-18 | Medtronic, Inc. | Methods of shielding implantable medical leads and implantable medical lead extensions |
US11213675B2 (en) | 2014-08-15 | 2022-01-04 | Axonics, Inc. | Implantable lead affixation structure for nerve stimulation to alleviate bladder dysfunction and other indication |
US9802038B2 (en) | 2014-08-15 | 2017-10-31 | Axonics Modulation Technologies, Inc. | Implantable lead affixation structure for nerve stimulation to alleviate bladder dysfunction and other indication |
US9427574B2 (en) | 2014-08-15 | 2016-08-30 | Axonics Modulation Technologies, Inc. | Implantable lead affixation structure for nerve stimulation to alleviate bladder dysfunction and other indication |
US10478619B2 (en) | 2014-08-15 | 2019-11-19 | Axonics Modulation Technologies, Inc. | Implantable lead affixation structure for nerve stimulation to alleviate bladder dysfunction and other indication |
US9789321B2 (en) | 2015-04-03 | 2017-10-17 | Nevro Corp. | Couplings for implanted leads and external stimulators, and associated systems and methods |
US11318310B1 (en) | 2015-10-26 | 2022-05-03 | Nevro Corp. | Neuromodulation for altering autonomic functions, and associated systems and methods |
US10195423B2 (en) | 2016-01-19 | 2019-02-05 | Axonics Modulation Technologies, Inc. | Multichannel clip device and methods of use |
US9517338B1 (en) | 2016-01-19 | 2016-12-13 | Axonics Modulation Technologies, Inc. | Multichannel clip device and methods of use |
US11596798B2 (en) | 2016-01-25 | 2023-03-07 | Nevro Corp | Treatment of congestive heart failure with electrical stimulation, and associated systems and methods |
US10980999B2 (en) | 2017-03-09 | 2021-04-20 | Nevro Corp. | Paddle leads and delivery tools, and associated systems and methods |
US11759631B2 (en) | 2017-03-09 | 2023-09-19 | Nevro Corp. | Paddle leads and delivery tools, and associated systems and methods |
US20190054289A1 (en) * | 2017-08-17 | 2019-02-21 | Cardiac Pacemakers, Inc. | Retention mechanism for an implantable lead |
US11116966B2 (en) * | 2017-08-17 | 2021-09-14 | Cardiac Pacemakers, Inc. | Retention mechanism for an implantable lead |
US10888697B2 (en) | 2017-08-18 | 2021-01-12 | Cardiac Pacemakers, Inc. | Fixation mechanism for an implantable lead |
US11110283B2 (en) | 2018-02-22 | 2021-09-07 | Axonics, Inc. | Neurostimulation leads for trial nerve stimulation and methods of use |
US11511122B2 (en) | 2018-02-22 | 2022-11-29 | Axonics, Inc. | Neurostimulation leads for trial nerve stimulation and methods of use |
US11420045B2 (en) | 2018-03-29 | 2022-08-23 | Nevro Corp. | Leads having sidewall openings, and associated systems and methods |
US11147964B2 (en) | 2018-04-23 | 2021-10-19 | Cardiac Pacemakers, Inc. | Subcutaneous lead fixation member |
US11219775B2 (en) | 2018-05-01 | 2022-01-11 | Cardiac Pacemakers, Inc. | Retention mechanism for an implantable lead |
US11766571B2 (en) * | 2018-07-23 | 2023-09-26 | Cardiac Pacemakers, Inc. | Retention mechanism for an implantable lead |
US20220072317A1 (en) * | 2018-07-23 | 2022-03-10 | Cardiac Pacemakers, Inc. | Retention mechanism for an implantable lead |
US11202915B2 (en) * | 2018-07-23 | 2021-12-21 | Cardiac Pacemakers, Inc. | Retention mechanism for an implantable lead |
CN112469464A (en) * | 2018-07-23 | 2021-03-09 | 心脏起搏器股份公司 | Retention mechanism for implantable lead |
WO2020023487A1 (en) * | 2018-07-23 | 2020-01-30 | Cardiac Pacemakers, Inc. | Retention mechanism for an implantable lead |
US11590352B2 (en) | 2019-01-29 | 2023-02-28 | Nevro Corp. | Ramped therapeutic signals for modulating inhibitory interneurons, and associated systems and methods |
Also Published As
Publication number | Publication date |
---|---|
US20170151428A1 (en) | 2017-06-01 |
US9610435B2 (en) | 2017-04-04 |
US20150250998A1 (en) | 2015-09-10 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US9610435B2 (en) | Anchoring units for implantable electrical stimulation systems and methods of making and using | |
US11020586B2 (en) | Distally curved electrical stimulation lead and methods of making and using | |
US10286205B2 (en) | Systems and methods for making and using improved contact arrays for electrical stimulation systems | |
US9364658B2 (en) | Electrical stimulation leads with multiple anchoring units and methods of making and using | |
US8897889B2 (en) | Electrode design for leads of implantable electric stimulation systems and methods of making and using | |
US7803021B1 (en) | Implantable electrical stimulation systems with leaf spring connective contacts and methods of making and using | |
US10406353B2 (en) | Electrical stimulation leads with anchoring unit and electrode arrangement and methods of making and using | |
US8983608B2 (en) | Lead connector for an implantable electric stimulation system and methods of making and using | |
AU2014265848B2 (en) | Electrical stimulation leads and systems with anchoring units and methods of making and using | |
US20130317587A1 (en) | Methods for stimulating the dorsal root ganglion with a lead having segmented electrodes | |
US20090248095A1 (en) | Anchoring units for leads of implantable electric stimulation systems and methods of making and using | |
US8332049B2 (en) | Implantable multi-lead electric stimulation system and methods of making and using | |
US20110009933A1 (en) | Piggy-back percutaneous lead insertion kit | |
US8469971B2 (en) | Stylet for guiding leads of implantable electric stimulation systems and methods of making and using | |
US9669210B2 (en) | Electrical stimulation leads and systems with folding anchoring units and methods of making and using | |
US10716935B2 (en) | Electrical stimulation leads, systems and methods for stimulation of dorsal root ganglia | |
US8792994B2 (en) | Torsed sleeve lead anchor and systems and methods of manufacture and use thereof | |
US10179234B2 (en) | Distally reinforced lead and methods of making and using | |
US20160082247A1 (en) | Systems and methods for making and using anchoring arrangements for leads of electrical stimulation systems |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
AS | Assignment |
Owner name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION, CAL Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:SCHLEICHER, BRETT DANIEL;JOO, MICHAEL;SIGNING DATES FROM 20090401 TO 20090402;REEL/FRAME:024215/0173 |
|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |