US20140172012A1 - Vascular closure device suture tension mechanism - Google Patents
Vascular closure device suture tension mechanism Download PDFInfo
- Publication number
- US20140172012A1 US20140172012A1 US14/039,237 US201314039237A US2014172012A1 US 20140172012 A1 US20140172012 A1 US 20140172012A1 US 201314039237 A US201314039237 A US 201314039237A US 2014172012 A1 US2014172012 A1 US 2014172012A1
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- Prior art keywords
- elongated body
- resisting member
- resistance portion
- force
- closure device
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00623—Introducing or retrieving devices therefor
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00628—T-shaped occluders
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- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00646—Type of implements
- A61B2017/00663—Type of implements the implement being a suture
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B2017/0496—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials for tensioning sutures
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- A—HUMAN NECESSITIES
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/06166—Sutures
- A61B2017/06176—Sutures with protrusions, e.g. barbs
Definitions
- the present disclosure relates generally to systems and methods for sealing an opening in the body of a patient.
- This disclosure concerns apparatuses and methods useful for sealing an opening in a bodily wall, such as an access opening in the wall of a blood vessel or a fistula.
- apparatus and methods are disclosed for closing and allowing healing of an opening in a tissue wall, whether made during a medical procedure (e.g. those in which apparatus or medicaments are introduced into tissue) or naturally occurring (e.g. as a result of malformation or disease)
- a variety of devices e.g. needles, guide wires, cannulae
- Additional devices or implants can be moved through such devices, or through sleeves or cannulae placed in the opening to keep it open, and into the vessel.
- a cannula or other access device is removed from the vessel, leaving an opening in the vessel. If the arteriotomy is not adequately closed, a subcutaneous hematoma will form. The medical professional must therefore take steps to close the opening in the vessel. In some cases, the opening may be sutured closed, but such action can be very difficult in close quarters, and many vessel-accessing procedures are intended to be minimally-invasive to reduce tissue damage. It is also known to apply constant, firm external pressure to the opening in the vessel, particularly if it is a blood vessel, to allow the body's natural coagulation and healing processes to work.
- Devices have been created for inserting closures into a blood vessel or on its exterior that are designed to block the opening and/or soak up fluids that escape the vessel, or are present in the opening through the skin leading to the vessel. Such devices have, however, proven unsatisfactory in many respects, as have therapies for closing naturally-occurring openings in tissue. Needs therefore exist for improved and/or alternative devices and systems for inserting a closure for an opening in tissue that produces a seal without significantly blocking adjacent flow where desired (e.g. through a blood vessel), and fills the opening where that is desirable.
- the present disclosure provides systems and methods capable of sealing an opening in a bodily wall of a patient.
- such systems and methods use a resisting member applying a resistive force to an elongated body having a vascular closure device coupled to an end region.
- the present disclosure provides an apparatus coupled to a vascular closure device, the apparatus being constructed and arranged to interact with a resisting member comprising a grip portion to apply a force to the vascular closure device to substantially occlude a hole in a vessel wall.
- the apparatus can include: an elongated body comprising a proximal end region, a distal end region, a high-resistance portion, and a low-resistance portion, with the high-resistance portion positioned adjacent to the proximal end region, the low-resistance portion positioned adjacent to the distal end region, and the distal end region coupled to the vascular closure device.
- the elongated body is constructed and arranged to slidably couple with and contact the resisting member so as to cause a resistive force between the elongated body and the resisting member.
- the high-resistance portion is constructed and arranged to interface with the resisting member such that the resistance-resistive force is greater than a conforming force. Additionally, some embodiments disclose the resisting member and the high-resistance portion being constructed and arranged such that the resistive force is less than a deforming force. Some of these arrangements are formed by the high-resistance portion defining a large diameter portion and the low-resistance portion defining a small diameter portion. Furthermore, in some instances, the high-resistance portion defines a plurality of large-diameter portions separated by small-diameter portions along a length of the elongated body.
- the present disclosure provides a system arranged to conform a vascular closure device over a hole in a vessel wall to occlude the hole, including an elongated body comprising a proximal end region, a distal end region, a high-resistance portion, and a low-resistance portion.
- the high-resistance portion may be positioned adjacent to the proximal end region
- the low-resistance portion may be positioned adjacent to the distal end region
- the distal end region may be coupled to the vascular closure device.
- a resisting member including a grip portion is constructed and arranged to slidably couple with and contact the elongated body wherein a resistive force resists longitudinal movement between the elongated body and the resisting member.
- the high-resistance portion defines a large diameter portion and the low-resistance portion defines a small diameter portion.
- the system further comprises a stop member positioned at the proximal end region of the elongated body.
- Some embodiments of the present disclosure teach a system arranged to conform a vascular closure device over a hole in a vessel wall to occlude the hole, which includes an elongated body comprising a proximal end region and a distal end region, with the distal end region coupled to the vascular closure device.
- a resisting member including a grip portion is constructed and arranged to slidably couple with and contact the elongated body.
- the elongated body and the resisting member interface such that a resistive force resists longitudinal movement between the elongated body and the resisting member.
- the resistive force has a maximum static resistive force during a non-sliding condition and a maximum dynamic resistive force during a sliding condition.
- the maximum static resistive force is greater than a conforming force sufficient to occlude the hole.
- the maximum dynamic resistive force is greater than a conforming force sufficient to occlude the hole.
- the maximum static resistive force is less than a deforming force of the vascular closure device.
- FIG. 1 is a perspective view of an embodiment of a system for closing a hole in a vessel wall.
- FIG. 2 is a cross-sectional view of the system illustrated in FIG. 1 .
- FIG. 3 is a perspective view of one embodiment of an elongated body and vascular closure device.
- FIG. 4 is a cross-sectional side view of one embodiment of a vascular closure device coupled to an elongated body and in an unconformed configuration.
- FIG. 5 is a side elevational view of the vascular closure device of FIG. 4 under a conforming force.
- FIG. 6 is a side elevational view of the vascular closure device of FIG. 4 under a deforming force.
- FIG. 7 is a side elevational view of an elongated body having spherical protrusions, an end stop, and a vascular closure device coupled to one end.
- FIG. 8 is a side elevational view of an elongated body having shoulder protrusions, an end stop, and a vascular closure device coupled to one end.
- FIG. 9 is a side elevational view of an elongated body having tapered protrusions, an end stop, and a vascular closure device coupled to one end.
- FIG. 10 is a side elevational view of an elongated body having spherical protrusions in abutting contact, an end stop, and a vascular closure device coupled to one end.
- FIG. 11 is a side elevational view of an elongated body having a long protrusion with an irregular outer surface, an end stop, and a vascular closure device coupled to one end.
- FIG. 12 is a side elevational view of an elongated body having spherical protrusions increasing in diameter, an end stop, and a vascular closure device coupled to one end.
- FIG. 13 is a side elevational view of an elongated body having a series of abutting shoulder protrusions increasing in diameter, an end stop, and a vascular closure device coupled to one end.
- FIG. 14 is a cross-sectional view of an elongated body extending through a tortuous channel of a resisting member; the tortuous channel changing directions along a vertical axis.
- FIG. 15 is a cross-sectional view of an elongated body extending through a tortuous channel of a resisting member; the tortuous channel changing directions along both a vertical and horizontal axis.
- FIG. 16 is a side elevational view of a resisting member having a rolling resistance system.
- FIG. 17 is a side elevational view of a resisting member having a brake pad system.
- FIG. 18 is a side elevational view of a resisting member having a leaf spring system.
- FIG. 19 is a side elevational view of a valve-type resisting member.
- FIG. 20 is a perspective view of a belt friction system and/or a pulley system of a resisting member.
- FIG. 21 is a side elevational view of the system illustrated in FIG. 20 .
- FIG. 22 is a perspective view of one embodiment of an outer sheath.
- FIG. 23 is a cross-sectional view of one embodiment of an outer sheath.
- FIG. 24 is a cross-sectional view of a system for closing a hole in a vessel wall in a first position, with the introducer inserted into the outer sheath.
- FIG. 25 is the system illustrated in FIG. 24 in a second position, with the vascular closure device and insertion sheath advanced through the introducer.
- FIG. 26 is the system illustrated in FIG. 24 in a third position, with the vascular closure device advanced into the lumen of the vessel.
- FIG. 27 is the system illustrated in FIG. 24 , in a fourth position, with the vascular closure device retracted and contacting the inner surface of the vessel wall.
- FIG. 28 is the system illustrated in FIG. 24 in a fifth position, with the vascular closure device in a conforming configuration upon application of a conforming force from the elongated body.
- FIG. 29 is the system illustrated in FIG. 24 in a sixth position, with the outer sheath, the introducer, and the insertion sheath being withdrawn along the length of the elongated body, and a conforming force being applied to the vascular closure device.
- FIG. 30 is the system illustrated in FIG. 24 in a seventh position, with the packing member advanced over the elongated body and abutting against the outer surface of the vessel wall.
- FIG. 31 is the system illustrated in FIG. 24 in an eighth position, with the elongated body severed and removed, leaving the vascular closure device in situ.
- a system 100 for closing an opening in a wall of a vessel, conduit or other bodily cavity comprises an introducer 110 , an insertion sheath 140 , a resisting member 160 , an elongated body 200 , and, in some instances, a packing member 130 , a pushing member 132 , and/or an outer sheath 240 .
- the introducer 110 has a proximal end region 112 , a distal end region 114 and a wall 116 .
- the wall 116 has an inner surface 118 and an outer surface 120 .
- the inner surface 118 defines a lumen 122 that is constructed and arranged to receive the vascular closure device 230 and/or the insertion sheath 140 . In some instances, the inner surface 118 is constructed and arranged to slidably couple with an outer surface 150 of the insertion sheath.
- the wall 116 also forms a flange 124 on the outer surface 120 positioned near the proximal end region 112 of the introducer 110 .
- the flange 124 has a proximal surface 126 and a distal surface 128 .
- the proximal surface 126 is constructed and arranged to limit the distance that the insertion sheath 140 is insertable into the introducer 110 .
- the insertion sheath 140 is positionable within the lumen 122 of the introducer 110 .
- the insertion sheath 140 has a proximal end region 142 , a distal end region 144 , and a wall 146 having an inner surface 148 and an outer surface 150 .
- the inner surface 148 of the wall 146 defines a lumen 152 constructed and arranged to retain the elongated body 200 of the system 100 .
- the outer surface 150 is constructed and arranged to slidably couple with the inner surface 118 of the wall 116 of the introducer 110 so as to allow the insertion sheath 140 to slide within the lumen 122 of the introducer 110 .
- the wall 146 of the insertion sheath 140 comprises a flange 154 having a proximal surface 156 and a distal surface 158 .
- the distal surface 158 of the flange 154 is constructed and arranged to contact the proximal surface 126 of the flange 124 of the introducer 110 so as to prevent the insertion sheath 140 from sliding further into the lumen 122 of the introducer 110 .
- the flange 154 may also include a resisting member 160 .
- the resisting member 160 of the system 100 is constructed and arranged to resist movement, in at least one direction, of the elongated body 200 relative to the resisting member 160 .
- the resisting member 160 contacts a surface of the elongated body 200 and provides resistance through physical contact (e.g., friction and/or interfering features).
- the resisting member 160 has a friction surface constructed and arranged to contact the outer surface of the elongated body 200 and create a frictional resistance to movement of the elongated body 200 relative to the resisting member 160 .
- the resisting member 160 contacts a surface of the elongated body 200 and applies a resistive force thereto sufficient to conform the vascular closure device 230 to occlude the hole in the vessel wall.
- the resisting member 160 is supported by the hand of the operator. Additionally, or alternatively, the resisting member 160 can be a portion of and/or can be coupled to the insertion sheath 140 .
- the resisting member 160 comprises a valve that is coupled to and positioned on the proximal end region 142 of the insertion sheath 140 .
- resistive members 160 include but are not limited to cuffs, valves, resistive pads, and channels.
- FIG. 3 illustrates an exemplary embodiment of the elongated body 200 .
- the elongated body 200 comprises a proximal end region 202 and a distal end region 204 . Coupled to the distal end region 204 of the elongated body 200 is a vascular closure device 230 , such as a domed-shaped sealing member 232 .
- the elongated body 200 has a high resistance portion 206 and a low resistance portion 208 .
- the high resistance portion 206 is positioned near the proximal end region 202 and the low resistance portion 208 is positioned between the proximal end region 202 and the distal end region 204 of the elongated body 200 .
- the high resistance portion 206 and/or the low resistance portion 208 are constructed and arranged such that the high resistance portion 206 and resisting member 160 , when interfacing with one another, provide a higher resistive force than the low resistance portion 208 and the resisting member 160 do.
- the high resistance portion 206 has protrusions or bumps and the low resistance portion 208 has a substantially smooth surface.
- the high resistance portion 206 , low resistance portion 208 , and/or the resisting member 160 can be constructed and arranged for a number of purposes.
- the high resistance portion 206 is constructed and arranged such that upon interaction with the resisting member 160 sufficient force is exerted on the elongated body 200 and the vascular closure device 230 to conform the vascular closure device 230 against the wall of a vessel and close a hole in the vessel wall as described below.
- the high resistance portion 206 , low resistance portion 208 , and/or resisting member 160 be constructed and arranged to provide feedback to the operator.
- the high resistance portion 206 and/or low resistance portion 208 comprise features that provide a tactile feedback and/or an audible feedback through the resisting member 160 to the operator that he/she is applying sufficient force through the resisting member 160 and the elongated body 200 to properly conform the vascular closure device 230 to the vessel wall.
- the system 100 may also provide feedback regarding the relative movement between the elongated body 200 and the sheath 140 .
- the high resistance portion 206 and/or the resisting member 160 are constructed and arranged so as to provide an indication to the operator that the resisting member 160 is nearing the end of the elongated body 200 .
- the high resistance portion 206 of the elongated body 200 comprises portions having a greater diameter and/or cross-sectional area than other portions of the elongated body 200 .
- the high resistance portion 206 includes protrusions 210 .
- the protrusions 210 increase the resistance to movement of resisting member 160 relative to the elongated body 200 . This increased resistive force increases the force that is transferred from the resisting member 160 to the elongated body 200 through the contact of the resisting member 160 and the elongated body 200 . Therefore, the resisting member 160 exerts a greater force to the elongated body 200 and subsequently to the vascular closure device 230 .
- the high resistance portion 206 of the elongated body 200 has portions that cause a greater frictional resistance to movement of the resisting member 160 along a length of the elongated body 200 than other portions.
- the high resistance portion 206 has portions with a greater frictional resistance than the low resistance portion 208 .
- the frictional resistance to sliding movement of the resisting member 160 along the surface of the high resistance portion 206 and/or the low resistance portion 208 is greater than a conforming force, so as to conform the vascular closure device 230 to the wall of a vessel and close a hole in the vessel wall.
- the surface roughness of one portion may be coarser than the surface roughness of another portion (e.g., one portion may have an average surface roughness (R a ) of 25 micrometers or more with other portions having an R a of 0.4 micrometers or less).
- portions may have a different lay (such as different directions in directional lay and/or directional lay and random lay), different waviness, and/or different surface integrity, to name a few non-limiting examples.
- other arrangements may be used to vary the frictional resistance along a length of the elongated body, such as lubricating some portions of the elongated body 200 and leaving other portions dry.
- the elongated body 200 may include a locking member 222 positioned near the distal end region 204 .
- the locking member 222 may be constructed and arranged to secure a second vascular closure device positioned against the outer surface 1012 of the vessel wall 1008 (opposite of the first vascular closure device 230 ) and/or to secure a packing member 130 in and/or around the hole 2016 in the vessel wall.
- a locking member 222 is constructed and arranged so as to be capable of sustaining a conforming force between the first vascular closure device 230 and the second vascular closure device and/or the packing member 130 .
- the elongated body 200 coupled to the vascular closure device 230 is constructed and arranged so as to be capable of applying a conforming force to the vascular closure device 230 .
- the conforming force is the amount of force necessary to conform the vascular closure device 230 to the inner surface 1010 of the vessel wall 1008 , such that the vascular closure device 230 substantially occludes the hole 1016 in the vessel wall 1008 and substantially seals the hole 1016 to prevent or substantially reduce any blood from escaping the vessel 1006 .
- Illustrated in FIG. 4 is an exemplary vascular closure device 230 in an unstressed configuration.
- FIGS. 5 and 6 illustrate varying ranges of deformation that may be applied to vascular closure device 230 while substantially sealing hole 1016 . It should be understood that FIGS. 4-6 show exaggerated forms of vascular closure device 230 for illustrative purposes. Vascular closure devices may be used with different shapes as appropriate for particular applications.
- a force that is greater than the conforming force can be applied to the vascular closure device 230 through the elongated body 200 .
- a distorting force is applied, which is the lesser of the amount of force necessary to deform the vascular closure device 230 beyond a shape that occludes the hole 1016 in the vessel wall 1008 , the amount of force necessary to pull the vascular closure device 230 through the hole 1016 in the vessel wall 1008 , and/or the amount of force necessary to damage the vascular closure device 230 and/or the vessel wall 1008 .
- the vascular closure device 230 may be any implement used to cover and occlude a hole 1016 in a vessel wall. As will be apparent to one of ordinary skill in the art, a variety of vascular closure devices 230 may be used with the disclosed systems. For example, a domed-shaped sealing member 232 having a semi-elliptical shape in an unstressed configuration may be used. As will be appreciated by one of ordinary skill in the art, vascular closure devices 230 may have different shapes, different dimensions, different materials, and/or different properties. For example, a system 100 may be constructed and arranged to position and conform a vascular closure device 230 that may be left in situ after the procedure.
- FIGS. 7-13 illustrate various embodiments of the elongated body 200 .
- the elongated body 200 comprises ribs and/or protrusions 210 located in the proximal end region 202 of the elongated body 200 .
- the ribs and/or protrusions 210 can be of a variety of shapes, including barbs, knots, frusto-conical segments, or flat surfaces, to name a few non-limiting examples. Additionally, the ribs and/or protrusions 210 may be made monolithically with the elongated body 200 or separate from the elongated body 200 and attached to it later.
- the protrusions 210 comprise a series of spheres 212 spaced along the length of the proximal end region 202 of the elongated body 200 . As illustrated in FIG. 8 , the protrusions 210 comprise a series of shoulders 214 spaced along the length of a portion of the elongated body 200 . In some embodiments, the protrusions 210 include tapered portions such as wedges 216 that have a greater resistive force moving in a direction along the length of the elongated body 200 than in another direction. For example, as shown in FIG.
- the wedges 216 provide a greater resistive force to movement of the resisting member 160 in a proximal to distal direction along a length of the elongated body 200 than the resisting member 160 moving in a distal to proximal direction. This may be accomplished, for example, by one or more sides of a protrusion 210 having a sloped and/or slanted portion.
- the ribs and/or protrusions 210 are spaced serially along a length of the elongated body 200 and/or in abutting contact.
- the protrusions 210 are spaced with portions of lower resistance positioned between the higher resistance protrusions 210 .
- the spacing may be even or uneven and, in some instances, may increase or decrease in length along a proximal-to-distal direction or vice-versa.
- the ribs or protrusions 210 are in abutting contact such that the diameter of the elongated body 200 between the protrusions 210 is greater than the diameter of the elongated body 200 in the low resistance portion 208 (See FIG. 10 ).
- a series of protrusions 210 are combined together and/or one long protrusion 210 exists along a length of the elongated body 200 , as illustrated in FIG. 11 .
- a protrusion 210 has an irregular outer surface arranged to vary the resistive force exerted to the resisting member 160 , as the resisting member 160 travels along the surface of the protrusion 210 .
- individual and/or serial protrusions 210 increase or decrease in size, such as diameter, in a direction along a length of a portion of the elongated body 200 .
- the spheres 212 of the elongated body 200 increase in diameter as one moves proximally along the length of the elongated body 200 and nearing the end of the elongated body 200 in the proximal end region 202 .
- FIG. 13 illustrates an elongated body 200 having a series of abutting shoulder protrusions that increase in diameter.
- the elongated body 200 may optionally include an end stop 220 constructed and arranged to prevent the removal of the resisting member over the end of the elongated body 200 .
- FIGS. 14-21 illustrate various exemplary embodiments of the resisting member 160 of the system 100 .
- the resisting member 160 comprises a first block 164 and a second block 166 that cooperate to define a tortuous path for the elongated body 200 , such as a channel 162 .
- the tortuous path changes direction along a single axis and/or along more than one axis in the resisting member 160 .
- the channel 162 defined by the resisting member 160 extends continuously in a direction along a horizontal axis 169 and changing directions only along a vertical axis 167 .
- the channel 162 may change directions along both the horizontal axis 169 and the vertical axis 167 as it extends through the resisting member 160 , as illustrated in FIG. 15 .
- the shape and size of the tortuous path may be constructed and arranged by changing the shapes of the surfaces of the first block 164 and/or the second block 166 and/or by changing the orientation of the first block 164 relative to the second block 166 .
- the first block 164 and the second block 166 as illustrated in FIG. 14 , may be moved towards one another along the vertical axis 167 so as to decrease the size of the channel 162 and further constrain the elongated body 200 within the resisting member 160 .
- the first block 164 and the second block 166 may be moved in opposite directions along the horizontal axis 169 so as to decrease the size of only some portions of the channel 162 .
- the first block 164 and second block 166 may be attached together, held immovable with respect to each other, or constructed of a single piece.
- FIG. 16 illustrates one embodiment of the resisting member 160 comprising a rolling resistance system 170 having one or more rolling members 172 , a spring 174 , and/or an axle 176 .
- the rolling members 172 are positioned around the axle 176 and constructed and arranged to rotate.
- the spring 174 pushes on the axle 176 extending through the roller member 172 so as to force the rolling member 172 against the elongated body 200 . In some instances, this force increases the rolling resistance of the roller member 172 against the surface of the elongated body 200 and, therefore, increases the resistance to relative movement.
- the spring 174 comprises a torsion member and/or a breaking element coupled to the axle 176 and/or the roller members 172 .
- the torsion member may be constructed and arranged to resist the rotation of the rolling member 172 . This may be accomplished by coupling the torsion member to the rolling member 172 such that rotation of the rolling member 172 would twist the torsion member.
- the resistive force exerted by the torsion member would be variable, for example, such as by increasing the resistive force as the rolling member 172 twists the torsion member.
- FIG. 17 illustrates an alternative embodiment of the resisting member 160 comprising a brake pad system 180 .
- the brake pad system 180 comprising one or more brake pads 182 , and in some embodiments, one or more springs 184 .
- the brake pads 182 frictionally contact the surface of the elongated body 200 so as to frictionally resist movement of the elongated body 200 relative to the brake pads 182 .
- the springs 184 increase the contact force of the brake pad 182 to the surface of the elongated body 200 so as to increase the resistive force between the brake pad 182 and the elongated body 200 .
- FIG. 18 illustrates a leaf spring system 186 embodiment of a resisting member 160 .
- the leaf spring system 186 comprises one or more leaf springs 188 that contact the surface of the elongated body 200 and cause a frictional resistance to motion of the elongated body 200 relative to the leaf spring system 186 .
- FIG. 19 illustrates an embodiment of the resisting member 160 comprising a valve 190 .
- the valve 190 comprises a sealing member 192 within the valve that frictionally contacts the surface of the elongated body 200 .
- the valve 190 may comprise a hemostasis valve, such as a tuohy-borst valve, with the sealing member 192 in the valve 190 being adjustable.
- FIGS. 20 and 21 illustrate embodiments such as a belt friction system and/or a pulley system of the resisting member 160 .
- the system 194 comprises an elongated body 200 wrapped around a cylinder 196 that is fixedly coupled to an axle 198 . As one end of the elongated body 200 is pulled, only part of the force is transmitted to the other end due to the friction between the surface of the elongated body 200 and the cylinder 196 .
- the elongated body 200 is wrapped around the cylinder 196 one or more times, depending on the amount of force desired to be transmitted to the other portion of the elongated body 200 and/or the amount of force necessary to initiate a slipping condition between the elongated body 200 and the cylinder 196 . For example, if the operator desires more resistive force before the elongated body 200 begins to slip on the cylinder 196 , the operator may wrap the elongated body 200 around the cylinder 196 more times.
- the cylinder 196 may be fixedly coupled to a torsion member and rotationally coupled to the axle 198 , similar to that discussed with regards to the embodiment illustrated in FIG. 16 .
- the torsion member is twisted and resists additional twisting and rotation of the cylinder 196 .
- the resisting member 160 is integrated into a portion of the system 100 such as the insertion sheath 140 , introducer 110 , and/or the outer sheath 240 .
- the resisting member 160 is a separate component such as a sheath that an operator grips and slides along a length of a portion of the elongated body 200 .
- the resisting member 160 comprises a grip portion and is constructed and arranged to slidably couple with and contact a surface of the elongated body 200 wherein a resistive force resists longitudinal movement between the elongated body 200 and the resisting member 160 .
- the elongated body 200 and the resisting member 160 are constructed and arranged to generate specific resistive forces in static and/or dynamic (e.g., sliding) conditions.
- the maximum resistive force may be selected so as to be less than the deforming force of the vascular closure device 230 and/or greater than the conforming force of the vascular closure device 230 for when the elongated body 200 and resisting member 160 are in a static condition (e.g., not sliding).
- the maximum resistive force during a dynamic condition may be selected to be less than the deforming force of the vascular closure device 230 and/or greater than the conforming force.
- the static resistive force and/or the dynamic resistive force may be variable.
- the static resistive force and/or the dynamic resistive force may be variable along a length of a portion of the elongated body 200 .
- the interface between the resisting member 160 and the elongated body 200 may be arranged such that the static resistive force and/or the dynamic resistive force are selectively variable by an operator such that the operator may increase and/or decrease the resistive force in static and/or dynamic conditions so as to achieve the desired force on the vascular closure device 230 .
- FIGS. 22 and 23 illustrate an embodiment of the outer sheath 240 that may be included in the system 100 or outer sheath 240 may be a third party catheter introducer, for example.
- the outer sheath 240 comprises a proximal end region 242 , a distal end region 244 and a wall 264 having an inner surface 248 and an outer surface 250 .
- the inner surface 248 defines a lumen 252 arranged to receive the introducer 110 , insertion sheath 140 , and/or the vascular closing device 230 .
- the outer sheath 240 comprises a seal member 254 , such as a hemostasis valve, positioned in the proximal end region 242 .
- seal member 254 is used as the resisting member 160 .
- the system 100 includes a packing member 130 , a pushing member 132 , and a locking member 222 .
- the packing member 130 may be positioned within the insertion sheath 140 proximal to the vascular closure device 230 , and is coupled to the elongated body 200 .
- the packing member 130 and locking member 222 are slidably coupled to the elongated body 200 and pushing member 132 is arranged to push the locking member 222 against the packing member 130 to pack the packing member 130 against the outer surface 1012 of the vessel wall 1008 .
- the locking member 222 may retain the packing member 130 in position against the vessel wall 1008 .
- the locking member 222 may couple to a portion of the elongated body 200 in the distal end region 204 and apply a compressive force to the packing member 130 .
- the locking member 222 may be retained by a protrusion 224 in the distal end region 204 of the elongated body 200 .
- the locking member 222 may contact a portion of the packing member 130 and resist movement of the packing member 130 away from the vessel wall 1008 .
- system 100 may be constructed and arranged such that the force that the packing member 130 exerts on the locking member 222 is communicated to the vascular closure device 230 through the elongated body 200 and retains the vascular closure device 230 in a conformed configuration.
- the elongated body 200 , vascular closure device 230 , and/or packing member 130 can be made of any material suitable for implantation within the body of the patient.
- Appropriate materials include synthetic materials and a grown or harvested tissue, such as an extracellular matrix material (ECM) such as porcine small intestinal submucosa (SIS).
- ECM extracellular matrix material
- SIS porcine small intestinal submucosa
- spongy or foam materials or other forms of materials are used. Preparation of such materials is disclosed in U.S. patent application Ser. No. 12/489,199 (filed Jun. 22, 2009 and incorporated herein by reference in its entirety).
- the material is a collagenous extracellular matrix material such as SIS, and it is treated to partially denature and expand the native collagenous structure, for example with sodium hydroxide, to provide desired porosity and/or foam characteristics when dried.
- the extracellular matrix material can be processed to be medically acceptable while retaining a native collagenous microarchitecture (e.g. a native sheet form) and endogenous bioactive substances from an animal source tissue, such as a porcine, ovine, bovine or equine source tissue.
- a native collagenous microarchitecture e.g. a native sheet form
- endogenous bioactive substances from an animal source tissue, such as a porcine, ovine, bovine or equine source tissue.
- Such endogenous substances can for example include one, some, or all of growth factors (e.g., Fibroblast Growth Factor-2), glycosaminoglycans, and proteoglycans.
- the extracellular matrix material can be treated with a chemical crosslinking agent, for example glutaraldehyde or a carbodiimide, to add crosslinks over and above any native crosslinks present, or can lack any such treatment.
- a chemical crosslinking agent for example glutaraldehyde or a carbodiimide
- the elongated body 200 , vascular closure device 230 , and/or packing member 130 can comprise a reconstituted collagen sheet or foam, optionally crosslinked with a chemical crosslinker such as those discussed above.
- the portions of the system 100 that are not implanted into the body of the patient may be made of any number of materials.
- the introducer 110 , pushing member 132 , insertion sheath 140 , resisting member 160 , and/or outer sheath 240 may be made of plastic or other suitable material.
- the material may need to maintain its ridigity over a sufficient length (e.g., 10 to 20 cm or more), so that an operator may manipulate a proximal portion and impart movement of a distal portion, such as with pushing the pushing member 132 .
- the operator when pushing the packing member 130 with the pushing member 132 , the operator can manipulate such longer embodiments of the pushing member 132 from outside of the patient, with tactile feedback indicated passage of the packing member 130 and/or the locking member 222 past the protrusion 224 of the elongated body 200 .
- system 100 One method of use of system 100 will now be described with respect to closing and repairing an opening in a wall of a blood vessel.
- body tissues e.g., bile or other ducts
- seal(s) as described herein may be placed and held over fistula openings and against tissue substantially as described below, with packing members within the fistula to assist with healing or correction of the fistula.
- the vessel 1006 positioned beneath tissue 1000 such as skin 1002 and/or muscle/fat 1004 of the body of a patient.
- the vessel 1006 comprises a vessel wall 1008 having an inner surface 1010 , an outer surface 1012 , and the inner surface defining a lumen 1014 extending through the vessel 1006 .
- a surgeon or other medical professional performs and completes desired procedure(s) that involve access to the blood vessel 1006 through hole 1016 in wall 1008 (e.g., balloon catheterization or stenting procedures). If a sheath, cannula or other access device or portal was used for the procedure(s), it can be left in the vessel 1006 , and the system 100 described above may be inserted through it. If no such access device is present, or if a change of access device is necessary or desired, outer sheath 240 is placed in the opening by using a dilator with an introducer sheath so that the distal end 244 is inside the vessel 1006 . Seal member 254 may provide a barrier preventing blood from exiting the lumen 252 of the outer sheath 240 from the proximal end region 242 .
- the system 100 is inserted into the lumen 252 of the outer sheath 240 and advanced towards the vessel 1006 .
- the distal surface 128 of the flange 124 of the introducer 110 contacts a portion of the proximal end region 242 of the outer sheath 240 and prevents further insertion of the introducer 110 within the lumen 252 of the outer sheath 240 ( FIG. 24 ).
- the insertion sheath 140 , the elongated body 200 and the vascular closure device are advanced through the lumen 122 of the introducer 110 so as to position the vascular closure device 230 and/or portions of the insertion sheath 140 and/or the elongated body 200 within the lumen 252 of the outer sheath 240 .
- the insertion sheath 140 is advanced further so as to position the vascular closure device 230 within the lumen 1014 of the vessel 1006 , allowing the vascular closure device 230 to expand into an expanded configuration within the lumen 1014 (see FIG. 26 ).
- the resisting member 160 , elongated body 200 , insertion sheath 140 , introducer 110 , and/or outer sheath 240 are/is be withdrawn.
- the resisting member 160 contacts the outer surface of the elongated body 200 in the low resistance portion 208 and imparts a resistive force onto the elongated body 200 .
- the resistive force withdraws the elongated body 200 from the vessel 1006 so as to pull the vascular closure device 230 against the inner surface 1010 of the vessel wall 1008 thereby covering hole 1016
- the resisting member 160 slides along the elongated body 200 .
- the force exerted to the vascular closure device 230 by the elongated body 200 increases to at least a conforming force but less than a deforming force, so as to conform the vascular closure device 230 to the inner surface 1010 of the vessel wall 1008 , as shown in FIG. 28 .
- the operator continues to withdraw the insertion sheath 140 , introducer 110 and/or the outer sheath 240 along the length of the elongated body 200 such that additional protrusions 210 of the high resistance portion 206 are moved through the resisting member 160 .
- an amount of force between the conforming force and deforming force is being applied through the elongated body 200 to the vascular closure device 230 .
- the operator advances a packing member 130 towards the hole 1016 in the vessel wall 1008 by pushing on a pushing member 132 along a length of the elongated body 200 .
- the operator severs a portion of the elongated body 200 so as to leave the vascular closure device 230 in position against the inner surface 1010 of the vessel wall 1008 with the packing member 130 positioned against the outer surface 1012 of the vessel wall 1008 and a portion of the elongated body 200 in tensions between the vascular closure device 230 and the packing member 130 .
- the portion of the elongated body 200 left in situ exerts a conforming force to the vascular closure device 230 and the packing member 130 so as to substantially occlude the hole in the vessel wall.
- the high resistance portion 206 of the elongated body 200 is constructed and arranged to compensate for the force exerted by the pushing member 132 to push the packing member 130 against the vessel wall 1008 .
- the interaction between the resisting member 160 and the high resistance portion 206 is such that even when the operator is applying an opposing force to portions of the system 100 to secure the packing member 130 against the vessel wall 1008 , the distal end 204 of the elongated body 200 still applies at least a conforming force to the vascular closure device 230 .
- Closure is maintained by tension on the seal, and by deforming the seal so that a portion of it is held against the vessel by the reaction of the seal to the deformation.
Abstract
Systems and methods for sealing an opening in a wall within the body of a patient are disclosed. In one embodiment, the system has an elongated body coupled to a vascular closure device and a resisting member, the elongated body having a high resistance portion and a low resistance portion and being constructed and arranged to interface with a resisting member to apply a conforming force to a vascular closure device. In some exemplary embodiments, the elongated body comprises a large diameter portion positioned in a proximal end region of the elongated body. Methods and other embodiments are disclosed.
Description
- This application claims the benefit of U.S. Provisional Application No. 61/736,812 filed Dec. 13, 2012, which is hereby incorporated by reference.
- The present disclosure relates generally to systems and methods for sealing an opening in the body of a patient.
- This disclosure concerns apparatuses and methods useful for sealing an opening in a bodily wall, such as an access opening in the wall of a blood vessel or a fistula. In particular, apparatus and methods are disclosed for closing and allowing healing of an opening in a tissue wall, whether made during a medical procedure (e.g. those in which apparatus or medicaments are introduced into tissue) or naturally occurring (e.g. as a result of malformation or disease)
- It has long been known to insert devices into bodily vessels or conduits to provide therapy or for diagnostic purposes. For example, in cardiovascular medicine, it is known to insert catheters, stents and other devices into a patient's vascular system in order to evaluate or treat the patient. In the case of percutaneous transluminal angioplasty (PTA), an opening is made through the patient's skin and into a large or relatively large blood vessel, such as the femoral artery, and a balloon is inserted into the vessel and advanced to the location where vessel narrowing has occurred, such as by atherosclerosis. Similar procedures are used to implant stents to maintain flow through blood or other bodily vessels or ducts. In accessing the interior of a blood vessel, the interventionalist or medical professional must breach the integrity of the vessel. A variety of devices (e.g. needles, guide wires, cannulae) are known to open a path into a vessel via a percutaneous opening or other approach. Additional devices or implants can be moved through such devices, or through sleeves or cannulae placed in the opening to keep it open, and into the vessel.
- When the procedure is concluded, a cannula or other access device is removed from the vessel, leaving an opening in the vessel. If the arteriotomy is not adequately closed, a subcutaneous hematoma will form. The medical professional must therefore take steps to close the opening in the vessel. In some cases, the opening may be sutured closed, but such action can be very difficult in close quarters, and many vessel-accessing procedures are intended to be minimally-invasive to reduce tissue damage. It is also known to apply constant, firm external pressure to the opening in the vessel, particularly if it is a blood vessel, to allow the body's natural coagulation and healing processes to work. In cases in which angioplasty or similar treatment has taken place, however, commonly an anticoagulant has been administered to the patient, making natural closing of the opening in the vessel wall a longer or more difficult process. Maintaining physical pressure on a relatively large blood vessel for a time period sufficient for natural closure also presents at least inconvenience and discomfort to the patient in having to remain still and submit to that pressure, and there is the risk that too much pressure can damage the vessel or tissues that rely on continued flow through it.
- Therapies for closing naturally-occurring fistulae or other undesirable bodily openings are also known. Treatments have included closure by suturing or by covering the opening, and by other surgical techniques. Frequently these therapies have required open surgeries with their attendant difficulties.
- Devices have been created for inserting closures into a blood vessel or on its exterior that are designed to block the opening and/or soak up fluids that escape the vessel, or are present in the opening through the skin leading to the vessel. Such devices have, however, proven unsatisfactory in many respects, as have therapies for closing naturally-occurring openings in tissue. Needs therefore exist for improved and/or alternative devices and systems for inserting a closure for an opening in tissue that produces a seal without significantly blocking adjacent flow where desired (e.g. through a blood vessel), and fills the opening where that is desirable.
- In certain aspects, the present disclosure provides systems and methods capable of sealing an opening in a bodily wall of a patient. In accordance with some forms, such systems and methods use a resisting member applying a resistive force to an elongated body having a vascular closure device coupled to an end region. In some embodiments, the present disclosure provides an apparatus coupled to a vascular closure device, the apparatus being constructed and arranged to interact with a resisting member comprising a grip portion to apply a force to the vascular closure device to substantially occlude a hole in a vessel wall. The apparatus can include: an elongated body comprising a proximal end region, a distal end region, a high-resistance portion, and a low-resistance portion, with the high-resistance portion positioned adjacent to the proximal end region, the low-resistance portion positioned adjacent to the distal end region, and the distal end region coupled to the vascular closure device. The elongated body is constructed and arranged to slidably couple with and contact the resisting member so as to cause a resistive force between the elongated body and the resisting member.
- In some instances, the high-resistance portion is constructed and arranged to interface with the resisting member such that the resistance-resistive force is greater than a conforming force. Additionally, some embodiments disclose the resisting member and the high-resistance portion being constructed and arranged such that the resistive force is less than a deforming force. Some of these arrangements are formed by the high-resistance portion defining a large diameter portion and the low-resistance portion defining a small diameter portion. Furthermore, in some instances, the high-resistance portion defines a plurality of large-diameter portions separated by small-diameter portions along a length of the elongated body.
- In some aspects, the present disclosure provides a system arranged to conform a vascular closure device over a hole in a vessel wall to occlude the hole, including an elongated body comprising a proximal end region, a distal end region, a high-resistance portion, and a low-resistance portion. The high-resistance portion may be positioned adjacent to the proximal end region, the low-resistance portion may be positioned adjacent to the distal end region, and the distal end region may be coupled to the vascular closure device. A resisting member including a grip portion is constructed and arranged to slidably couple with and contact the elongated body wherein a resistive force resists longitudinal movement between the elongated body and the resisting member. In some instances, the high-resistance portion defines a large diameter portion and the low-resistance portion defines a small diameter portion. Additionally, the system further comprises a stop member positioned at the proximal end region of the elongated body.
- Some embodiments of the present disclosure teach a system arranged to conform a vascular closure device over a hole in a vessel wall to occlude the hole, which includes an elongated body comprising a proximal end region and a distal end region, with the distal end region coupled to the vascular closure device. A resisting member including a grip portion is constructed and arranged to slidably couple with and contact the elongated body. The elongated body and the resisting member interface such that a resistive force resists longitudinal movement between the elongated body and the resisting member. As an example, the resistive force has a maximum static resistive force during a non-sliding condition and a maximum dynamic resistive force during a sliding condition. An operator applies force to the grip portion of the resisting member and the resisting member applies force up to the maximum static resistive force or the maximum dynamic resistive force to the elongated body. The maximum static resistive force is greater than a conforming force sufficient to occlude the hole. In some cases, the maximum dynamic resistive force is greater than a conforming force sufficient to occlude the hole. Additionally, in some embodiments, the maximum static resistive force is less than a deforming force of the vascular closure device.
- Further forms, objects, features, aspects, benefits, advantages, and embodiments of the present invention will become apparent from a detailed description and drawings provided herewith.
-
FIG. 1 is a perspective view of an embodiment of a system for closing a hole in a vessel wall. -
FIG. 2 is a cross-sectional view of the system illustrated inFIG. 1 . -
FIG. 3 is a perspective view of one embodiment of an elongated body and vascular closure device. -
FIG. 4 is a cross-sectional side view of one embodiment of a vascular closure device coupled to an elongated body and in an unconformed configuration. -
FIG. 5 is a side elevational view of the vascular closure device ofFIG. 4 under a conforming force. -
FIG. 6 is a side elevational view of the vascular closure device ofFIG. 4 under a deforming force. -
FIG. 7 is a side elevational view of an elongated body having spherical protrusions, an end stop, and a vascular closure device coupled to one end. -
FIG. 8 is a side elevational view of an elongated body having shoulder protrusions, an end stop, and a vascular closure device coupled to one end. -
FIG. 9 is a side elevational view of an elongated body having tapered protrusions, an end stop, and a vascular closure device coupled to one end. -
FIG. 10 is a side elevational view of an elongated body having spherical protrusions in abutting contact, an end stop, and a vascular closure device coupled to one end. -
FIG. 11 is a side elevational view of an elongated body having a long protrusion with an irregular outer surface, an end stop, and a vascular closure device coupled to one end. -
FIG. 12 is a side elevational view of an elongated body having spherical protrusions increasing in diameter, an end stop, and a vascular closure device coupled to one end. -
FIG. 13 is a side elevational view of an elongated body having a series of abutting shoulder protrusions increasing in diameter, an end stop, and a vascular closure device coupled to one end. -
FIG. 14 is a cross-sectional view of an elongated body extending through a tortuous channel of a resisting member; the tortuous channel changing directions along a vertical axis. -
FIG. 15 is a cross-sectional view of an elongated body extending through a tortuous channel of a resisting member; the tortuous channel changing directions along both a vertical and horizontal axis. -
FIG. 16 is a side elevational view of a resisting member having a rolling resistance system. -
FIG. 17 is a side elevational view of a resisting member having a brake pad system. -
FIG. 18 is a side elevational view of a resisting member having a leaf spring system. -
FIG. 19 is a side elevational view of a valve-type resisting member. -
FIG. 20 is a perspective view of a belt friction system and/or a pulley system of a resisting member. -
FIG. 21 is a side elevational view of the system illustrated inFIG. 20 . -
FIG. 22 is a perspective view of one embodiment of an outer sheath. -
FIG. 23 is a cross-sectional view of one embodiment of an outer sheath. -
FIG. 24 is a cross-sectional view of a system for closing a hole in a vessel wall in a first position, with the introducer inserted into the outer sheath. -
FIG. 25 is the system illustrated inFIG. 24 in a second position, with the vascular closure device and insertion sheath advanced through the introducer. -
FIG. 26 is the system illustrated inFIG. 24 in a third position, with the vascular closure device advanced into the lumen of the vessel. -
FIG. 27 is the system illustrated inFIG. 24 , in a fourth position, with the vascular closure device retracted and contacting the inner surface of the vessel wall. -
FIG. 28 is the system illustrated inFIG. 24 in a fifth position, with the vascular closure device in a conforming configuration upon application of a conforming force from the elongated body. -
FIG. 29 is the system illustrated inFIG. 24 in a sixth position, with the outer sheath, the introducer, and the insertion sheath being withdrawn along the length of the elongated body, and a conforming force being applied to the vascular closure device. -
FIG. 30 is the system illustrated inFIG. 24 in a seventh position, with the packing member advanced over the elongated body and abutting against the outer surface of the vessel wall. -
FIG. 31 is the system illustrated inFIG. 24 in an eighth position, with the elongated body severed and removed, leaving the vascular closure device in situ. - For the purpose of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any alterations and further modifications in the described embodiments, and any further applications of the principles of the invention as described herein are contemplated as would normally occur to one skilled in the art to which the invention relates.
- With respect to the specification and claims, it should be noted that the singular forms “a”, “an”, “the”, and the like include plural referents unless expressly discussed otherwise. As an illustration, references to “a device” or “the device” include one or more of such devices and equivalents thereof. It also should be noted that directional terms, such as “up”, “down”, “top”, “bottom”, and the like, are used herein solely for the convenience of the reader in order to aid in the reader's understanding of the illustrated embodiments, and it is not the intent that the use of these directional terms in any manner limit the described, illustrated, and/or claimed features to a specific direction and/or orientation.
- The description below will focus on use in blood vessels of a human or animal, but it will be understood that the structures disclosed herein have application to a number of other vessels or conduits or bodily cavities. Closure or treatment of undesired openings in a variety of tissues can be performed with structures and methodology as disclosed. Examples of other applications include sealing primary and/or secondary openings of a fistula with healing or correction (e.g., filling) of the fistula between the openings. Such fistulae may include vesico-vaginal fistulae, which are abnormal passages between the vagina and bladder.
- Referring now to an exemplary embodiment illustrated in
FIGS. 1 and 2 , asystem 100 for closing an opening in a wall of a vessel, conduit or other bodily cavity comprises anintroducer 110, aninsertion sheath 140, a resistingmember 160, anelongated body 200, and, in some instances, a packingmember 130, a pushingmember 132, and/or anouter sheath 240. Theintroducer 110 has aproximal end region 112, adistal end region 114 and awall 116. Thewall 116 has aninner surface 118 and anouter surface 120. Theinner surface 118 defines alumen 122 that is constructed and arranged to receive thevascular closure device 230 and/or theinsertion sheath 140. In some instances, theinner surface 118 is constructed and arranged to slidably couple with anouter surface 150 of the insertion sheath. - The
wall 116 also forms aflange 124 on theouter surface 120 positioned near theproximal end region 112 of theintroducer 110. In some embodiments, theflange 124 has aproximal surface 126 and adistal surface 128. Theproximal surface 126 is constructed and arranged to limit the distance that theinsertion sheath 140 is insertable into theintroducer 110. - As illustrated in
FIG. 2 , theinsertion sheath 140 is positionable within thelumen 122 of theintroducer 110. Theinsertion sheath 140 has aproximal end region 142, adistal end region 144, and awall 146 having aninner surface 148 and anouter surface 150. Theinner surface 148 of thewall 146 defines alumen 152 constructed and arranged to retain theelongated body 200 of thesystem 100. Theouter surface 150 is constructed and arranged to slidably couple with theinner surface 118 of thewall 116 of theintroducer 110 so as to allow theinsertion sheath 140 to slide within thelumen 122 of theintroducer 110. - The
wall 146 of theinsertion sheath 140 comprises aflange 154 having aproximal surface 156 and adistal surface 158. In some embodiments, thedistal surface 158 of theflange 154 is constructed and arranged to contact theproximal surface 126 of theflange 124 of theintroducer 110 so as to prevent theinsertion sheath 140 from sliding further into thelumen 122 of theintroducer 110. Theflange 154 may also include a resistingmember 160. - The resisting
member 160 of thesystem 100 is constructed and arranged to resist movement, in at least one direction, of theelongated body 200 relative to the resistingmember 160. In some instances, the resistingmember 160 contacts a surface of theelongated body 200 and provides resistance through physical contact (e.g., friction and/or interfering features). For example, the resistingmember 160 has a friction surface constructed and arranged to contact the outer surface of theelongated body 200 and create a frictional resistance to movement of theelongated body 200 relative to the resistingmember 160. In some embodiments, the resistingmember 160 contacts a surface of theelongated body 200 and applies a resistive force thereto sufficient to conform thevascular closure device 230 to occlude the hole in the vessel wall. - In some embodiments the resisting
member 160 is supported by the hand of the operator. Additionally, or alternatively, the resistingmember 160 can be a portion of and/or can be coupled to theinsertion sheath 140. For example, as illustrated inFIG. 2 , the resistingmember 160 comprises a valve that is coupled to and positioned on theproximal end region 142 of theinsertion sheath 140. Examples ofresistive members 160 include but are not limited to cuffs, valves, resistive pads, and channels. -
FIG. 3 illustrates an exemplary embodiment of theelongated body 200. Theelongated body 200 comprises aproximal end region 202 and adistal end region 204. Coupled to thedistal end region 204 of theelongated body 200 is avascular closure device 230, such as a domed-shapedsealing member 232. In some instances, theelongated body 200 has ahigh resistance portion 206 and alow resistance portion 208. In some embodiments, thehigh resistance portion 206 is positioned near theproximal end region 202 and thelow resistance portion 208 is positioned between theproximal end region 202 and thedistal end region 204 of theelongated body 200. Thehigh resistance portion 206 and/or thelow resistance portion 208 are constructed and arranged such that thehigh resistance portion 206 and resistingmember 160, when interfacing with one another, provide a higher resistive force than thelow resistance portion 208 and the resistingmember 160 do. For example, thehigh resistance portion 206 has protrusions or bumps and thelow resistance portion 208 has a substantially smooth surface. - The
high resistance portion 206,low resistance portion 208, and/or the resistingmember 160 can be constructed and arranged for a number of purposes. For example, thehigh resistance portion 206 is constructed and arranged such that upon interaction with the resistingmember 160 sufficient force is exerted on theelongated body 200 and thevascular closure device 230 to conform thevascular closure device 230 against the wall of a vessel and close a hole in the vessel wall as described below. In some instances, thehigh resistance portion 206,low resistance portion 208, and/or resistingmember 160 be constructed and arranged to provide feedback to the operator. For example, thehigh resistance portion 206 and/orlow resistance portion 208 comprise features that provide a tactile feedback and/or an audible feedback through the resistingmember 160 to the operator that he/she is applying sufficient force through the resistingmember 160 and theelongated body 200 to properly conform thevascular closure device 230 to the vessel wall. Thesystem 100 may also provide feedback regarding the relative movement between theelongated body 200 and thesheath 140. Similarly, in some embodiments, thehigh resistance portion 206 and/or the resistingmember 160 are constructed and arranged so as to provide an indication to the operator that the resistingmember 160 is nearing the end of theelongated body 200. - In some instances, the
high resistance portion 206 of theelongated body 200 comprises portions having a greater diameter and/or cross-sectional area than other portions of theelongated body 200. For example, thehigh resistance portion 206 includesprotrusions 210. In some embodiments, theprotrusions 210 increase the resistance to movement of resistingmember 160 relative to theelongated body 200. This increased resistive force increases the force that is transferred from the resistingmember 160 to theelongated body 200 through the contact of the resistingmember 160 and theelongated body 200. Therefore, the resistingmember 160 exerts a greater force to theelongated body 200 and subsequently to thevascular closure device 230. - In some embodiments, the
high resistance portion 206 of theelongated body 200 has portions that cause a greater frictional resistance to movement of the resistingmember 160 along a length of theelongated body 200 than other portions. For example, thehigh resistance portion 206 has portions with a greater frictional resistance than thelow resistance portion 208. Furthermore, in some instances, the frictional resistance to sliding movement of the resistingmember 160 along the surface of thehigh resistance portion 206 and/or thelow resistance portion 208 is greater than a conforming force, so as to conform thevascular closure device 230 to the wall of a vessel and close a hole in the vessel wall. - Various arrangements for varying the frictional resistance along a length of the
elongated body 200 are contemplated. For example, the surface roughness of one portion may be coarser than the surface roughness of another portion (e.g., one portion may have an average surface roughness (Ra) of 25 micrometers or more with other portions having an Ra of 0.4 micrometers or less). Similarly, portions may have a different lay (such as different directions in directional lay and/or directional lay and random lay), different waviness, and/or different surface integrity, to name a few non-limiting examples. As will be appreciated, other arrangements may be used to vary the frictional resistance along a length of the elongated body, such as lubricating some portions of theelongated body 200 and leaving other portions dry. - As shown in FIGS. 2 and 24-31, the
elongated body 200 may include a lockingmember 222 positioned near thedistal end region 204. The lockingmember 222 may be constructed and arranged to secure a second vascular closure device positioned against theouter surface 1012 of the vessel wall 1008 (opposite of the first vascular closure device 230) and/or to secure a packingmember 130 in and/or around the hole 2016 in the vessel wall. In many embodiments, a lockingmember 222 is constructed and arranged so as to be capable of sustaining a conforming force between the firstvascular closure device 230 and the second vascular closure device and/or the packingmember 130. - The
elongated body 200 coupled to thevascular closure device 230 is constructed and arranged so as to be capable of applying a conforming force to thevascular closure device 230. The conforming force is the amount of force necessary to conform thevascular closure device 230 to theinner surface 1010 of thevessel wall 1008, such that thevascular closure device 230 substantially occludes thehole 1016 in thevessel wall 1008 and substantially seals thehole 1016 to prevent or substantially reduce any blood from escaping thevessel 1006. Illustrated inFIG. 4 is an exemplaryvascular closure device 230 in an unstressed configuration. As a conforming force is applied to thevascular closure device 230 by theelongated body 200, thevascular closure device 230 deforms into a conforming configuration, as illustrated inFIGS. 5 and 6 .FIGS. 5 and 6 illustrate varying ranges of deformation that may be applied tovascular closure device 230 while substantially sealinghole 1016. It should be understood thatFIGS. 4-6 show exaggerated forms ofvascular closure device 230 for illustrative purposes. Vascular closure devices may be used with different shapes as appropriate for particular applications. - A force that is greater than the conforming force can be applied to the
vascular closure device 230 through theelongated body 200. In some instances, a distorting force is applied, which is the lesser of the amount of force necessary to deform thevascular closure device 230 beyond a shape that occludes thehole 1016 in thevessel wall 1008, the amount of force necessary to pull thevascular closure device 230 through thehole 1016 in thevessel wall 1008, and/or the amount of force necessary to damage thevascular closure device 230 and/or thevessel wall 1008. - The
vascular closure device 230 may be any implement used to cover and occlude ahole 1016 in a vessel wall. As will be apparent to one of ordinary skill in the art, a variety ofvascular closure devices 230 may be used with the disclosed systems. For example, a domed-shapedsealing member 232 having a semi-elliptical shape in an unstressed configuration may be used. As will be appreciated by one of ordinary skill in the art,vascular closure devices 230 may have different shapes, different dimensions, different materials, and/or different properties. For example, asystem 100 may be constructed and arranged to position and conform avascular closure device 230 that may be left in situ after the procedure. -
FIGS. 7-13 illustrate various embodiments of theelongated body 200. As illustrated inFIG. 7 , theelongated body 200 comprises ribs and/orprotrusions 210 located in theproximal end region 202 of theelongated body 200. The ribs and/orprotrusions 210 can be of a variety of shapes, including barbs, knots, frusto-conical segments, or flat surfaces, to name a few non-limiting examples. Additionally, the ribs and/orprotrusions 210 may be made monolithically with theelongated body 200 or separate from theelongated body 200 and attached to it later. - In some instances, the
protrusions 210 comprise a series ofspheres 212 spaced along the length of theproximal end region 202 of theelongated body 200. As illustrated inFIG. 8 , theprotrusions 210 comprise a series ofshoulders 214 spaced along the length of a portion of theelongated body 200. In some embodiments, theprotrusions 210 include tapered portions such aswedges 216 that have a greater resistive force moving in a direction along the length of theelongated body 200 than in another direction. For example, as shown inFIG. 9 , thewedges 216 provide a greater resistive force to movement of the resistingmember 160 in a proximal to distal direction along a length of theelongated body 200 than the resistingmember 160 moving in a distal to proximal direction. This may be accomplished, for example, by one or more sides of aprotrusion 210 having a sloped and/or slanted portion. - The ribs and/or
protrusions 210 are spaced serially along a length of theelongated body 200 and/or in abutting contact. For example, theprotrusions 210 are spaced with portions of lower resistance positioned between thehigher resistance protrusions 210. The spacing may be even or uneven and, in some instances, may increase or decrease in length along a proximal-to-distal direction or vice-versa. - In some embodiments, the ribs or
protrusions 210 are in abutting contact such that the diameter of theelongated body 200 between theprotrusions 210 is greater than the diameter of theelongated body 200 in the low resistance portion 208 (SeeFIG. 10 ). In some instances, a series ofprotrusions 210 are combined together and/or onelong protrusion 210 exists along a length of theelongated body 200, as illustrated inFIG. 11 . In some situations, aprotrusion 210 has an irregular outer surface arranged to vary the resistive force exerted to the resistingmember 160, as the resistingmember 160 travels along the surface of theprotrusion 210. - In some instances, individual and/or
serial protrusions 210 increase or decrease in size, such as diameter, in a direction along a length of a portion of theelongated body 200. For instance, as shown inFIG. 12 , thespheres 212 of theelongated body 200 increase in diameter as one moves proximally along the length of theelongated body 200 and nearing the end of theelongated body 200 in theproximal end region 202.FIG. 13 illustrates anelongated body 200 having a series of abutting shoulder protrusions that increase in diameter. Additionally, in some embodiments, theelongated body 200 may optionally include anend stop 220 constructed and arranged to prevent the removal of the resisting member over the end of theelongated body 200. -
FIGS. 14-21 illustrate various exemplary embodiments of the resistingmember 160 of thesystem 100. As illustrated inFIGS. 14 and 15 , the resistingmember 160 comprises afirst block 164 and asecond block 166 that cooperate to define a tortuous path for theelongated body 200, such as achannel 162. - In some embodiments, the tortuous path changes direction along a single axis and/or along more than one axis in the resisting
member 160. For example, as illustrated inFIG. 14 , thechannel 162 defined by the resistingmember 160 extends continuously in a direction along ahorizontal axis 169 and changing directions only along avertical axis 167. Alternatively, thechannel 162 may change directions along both thehorizontal axis 169 and thevertical axis 167 as it extends through the resistingmember 160, as illustrated inFIG. 15 . - The shape and size of the tortuous path may be constructed and arranged by changing the shapes of the surfaces of the
first block 164 and/or thesecond block 166 and/or by changing the orientation of thefirst block 164 relative to thesecond block 166. For instance, thefirst block 164 and thesecond block 166, as illustrated inFIG. 14 , may be moved towards one another along thevertical axis 167 so as to decrease the size of thechannel 162 and further constrain theelongated body 200 within the resistingmember 160. Alternatively, or in addition, thefirst block 164 and thesecond block 166 may be moved in opposite directions along thehorizontal axis 169 so as to decrease the size of only some portions of thechannel 162. Thefirst block 164 andsecond block 166 may be attached together, held immovable with respect to each other, or constructed of a single piece. -
FIG. 16 illustrates one embodiment of the resistingmember 160 comprising a rollingresistance system 170 having one or morerolling members 172, a spring 174, and/or anaxle 176. The rollingmembers 172 are positioned around theaxle 176 and constructed and arranged to rotate. In some embodiments, the spring 174 pushes on theaxle 176 extending through theroller member 172 so as to force the rollingmember 172 against theelongated body 200. In some instances, this force increases the rolling resistance of theroller member 172 against the surface of theelongated body 200 and, therefore, increases the resistance to relative movement. In some embodiments, the spring 174 comprises a torsion member and/or a breaking element coupled to theaxle 176 and/or theroller members 172. For example, the torsion member may be constructed and arranged to resist the rotation of the rollingmember 172. This may be accomplished by coupling the torsion member to the rollingmember 172 such that rotation of the rollingmember 172 would twist the torsion member. Advantageously, in some cases, the resistive force exerted by the torsion member would be variable, for example, such as by increasing the resistive force as the rollingmember 172 twists the torsion member. -
FIG. 17 illustrates an alternative embodiment of the resistingmember 160 comprising abrake pad system 180. Thebrake pad system 180 comprising one ormore brake pads 182, and in some embodiments, one or more springs 184. Thebrake pads 182 frictionally contact the surface of theelongated body 200 so as to frictionally resist movement of theelongated body 200 relative to thebrake pads 182. Thesprings 184 increase the contact force of thebrake pad 182 to the surface of theelongated body 200 so as to increase the resistive force between thebrake pad 182 and theelongated body 200. -
FIG. 18 illustrates aleaf spring system 186 embodiment of a resistingmember 160. Theleaf spring system 186 comprises one ormore leaf springs 188 that contact the surface of theelongated body 200 and cause a frictional resistance to motion of theelongated body 200 relative to theleaf spring system 186. -
FIG. 19 illustrates an embodiment of the resistingmember 160 comprising avalve 190. In some instances, thevalve 190 comprises a sealingmember 192 within the valve that frictionally contacts the surface of theelongated body 200. In some embodiments, thevalve 190 may comprise a hemostasis valve, such as a tuohy-borst valve, with the sealingmember 192 in thevalve 190 being adjustable. -
FIGS. 20 and 21 illustrate embodiments such as a belt friction system and/or a pulley system of the resistingmember 160. In some instances, thesystem 194 comprises anelongated body 200 wrapped around acylinder 196 that is fixedly coupled to anaxle 198. As one end of theelongated body 200 is pulled, only part of the force is transmitted to the other end due to the friction between the surface of theelongated body 200 and thecylinder 196. Theelongated body 200 is wrapped around thecylinder 196 one or more times, depending on the amount of force desired to be transmitted to the other portion of theelongated body 200 and/or the amount of force necessary to initiate a slipping condition between theelongated body 200 and thecylinder 196. For example, if the operator desires more resistive force before theelongated body 200 begins to slip on thecylinder 196, the operator may wrap theelongated body 200 around thecylinder 196 more times. - Alternatively, the
cylinder 196 may be fixedly coupled to a torsion member and rotationally coupled to theaxle 198, similar to that discussed with regards to the embodiment illustrated inFIG. 16 . In some instances, as theelongated body 200 rotates thecylinder 196 around theaxle 198, the torsion member is twisted and resists additional twisting and rotation of thecylinder 196. - In some embodiments, the resisting
member 160 is integrated into a portion of thesystem 100 such as theinsertion sheath 140,introducer 110, and/or theouter sheath 240. In other instances, the resistingmember 160 is a separate component such as a sheath that an operator grips and slides along a length of a portion of theelongated body 200. In several embodiments, the resistingmember 160 comprises a grip portion and is constructed and arranged to slidably couple with and contact a surface of theelongated body 200 wherein a resistive force resists longitudinal movement between theelongated body 200 and the resistingmember 160. - In some instances, the
elongated body 200 and the resistingmember 160 are constructed and arranged to generate specific resistive forces in static and/or dynamic (e.g., sliding) conditions. For example, the maximum resistive force may be selected so as to be less than the deforming force of thevascular closure device 230 and/or greater than the conforming force of thevascular closure device 230 for when theelongated body 200 and resistingmember 160 are in a static condition (e.g., not sliding). Similarly, the maximum resistive force during a dynamic condition may be selected to be less than the deforming force of thevascular closure device 230 and/or greater than the conforming force. - In some instances, the static resistive force and/or the dynamic resistive force may be variable. For instance, the static resistive force and/or the dynamic resistive force may be variable along a length of a portion of the
elongated body 200. Alternatively, or additionally, the interface between the resistingmember 160 and theelongated body 200 may be arranged such that the static resistive force and/or the dynamic resistive force are selectively variable by an operator such that the operator may increase and/or decrease the resistive force in static and/or dynamic conditions so as to achieve the desired force on thevascular closure device 230. -
FIGS. 22 and 23 illustrate an embodiment of theouter sheath 240 that may be included in thesystem 100 orouter sheath 240 may be a third party catheter introducer, for example. Theouter sheath 240 comprises aproximal end region 242, adistal end region 244 and a wall 264 having aninner surface 248 and anouter surface 250. Theinner surface 248 defines alumen 252 arranged to receive theintroducer 110,insertion sheath 140, and/or thevascular closing device 230. In some instances, theouter sheath 240 comprises aseal member 254, such as a hemostasis valve, positioned in theproximal end region 242. In some embodiments,seal member 254 is used as the resistingmember 160. - In some embodiments, the
system 100 includes a packingmember 130, a pushingmember 132, and a lockingmember 222. The packingmember 130 may be positioned within theinsertion sheath 140 proximal to thevascular closure device 230, and is coupled to theelongated body 200. In some embodiments, such as those illustrated in FIGS. 2 and 24-31, the packingmember 130 and lockingmember 222 are slidably coupled to theelongated body 200 and pushingmember 132 is arranged to push the lockingmember 222 against the packingmember 130 to pack the packingmember 130 against theouter surface 1012 of thevessel wall 1008. - In the embodiments having a locking
member 222, the lockingmember 222 may retain the packingmember 130 in position against thevessel wall 1008. For example, the lockingmember 222 may couple to a portion of theelongated body 200 in thedistal end region 204 and apply a compressive force to the packingmember 130. In some instances, the lockingmember 222 may be retained by aprotrusion 224 in thedistal end region 204 of theelongated body 200. As the packingmember 130 is positioned adjacent to theouter surface 1012 of thevessel wall 1008 by the pushing force of the pushingmember 132, the lockingmember 222 may contact a portion of the packingmember 130 and resist movement of the packingmember 130 away from thevessel wall 1008. Similarly, thesystem 100 may be constructed and arranged such that the force that the packingmember 130 exerts on the lockingmember 222 is communicated to thevascular closure device 230 through theelongated body 200 and retains thevascular closure device 230 in a conformed configuration. - The above mentioned components may be made using materials and methods apparent to one of ordinary skill in the art. For example, the
elongated body 200,vascular closure device 230, and/or packingmember 130 can be made of any material suitable for implantation within the body of the patient. Appropriate materials include synthetic materials and a grown or harvested tissue, such as an extracellular matrix material (ECM) such as porcine small intestinal submucosa (SIS). In some instances, spongy or foam materials or other forms of materials are used. Preparation of such materials is disclosed in U.S. patent application Ser. No. 12/489,199 (filed Jun. 22, 2009 and incorporated herein by reference in its entirety). - As noted above, in particular embodiments the material is a collagenous extracellular matrix material such as SIS, and it is treated to partially denature and expand the native collagenous structure, for example with sodium hydroxide, to provide desired porosity and/or foam characteristics when dried. In certain embodiments, the extracellular matrix material can be processed to be medically acceptable while retaining a native collagenous microarchitecture (e.g. a native sheet form) and endogenous bioactive substances from an animal source tissue, such as a porcine, ovine, bovine or equine source tissue. Such endogenous substances can for example include one, some, or all of growth factors (e.g., Fibroblast Growth Factor-2), glycosaminoglycans, and proteoglycans. The extracellular matrix material can be treated with a chemical crosslinking agent, for example glutaraldehyde or a carbodiimide, to add crosslinks over and above any native crosslinks present, or can lack any such treatment. In other embodiments, the
elongated body 200,vascular closure device 230, and/or packingmember 130 can comprise a reconstituted collagen sheet or foam, optionally crosslinked with a chemical crosslinker such as those discussed above. - The portions of the
system 100 that are not implanted into the body of the patient may be made of any number of materials. For example, theintroducer 110, pushingmember 132,insertion sheath 140, resistingmember 160, and/orouter sheath 240 may be made of plastic or other suitable material. In some instances the material may need to maintain its ridigity over a sufficient length (e.g., 10 to 20 cm or more), so that an operator may manipulate a proximal portion and impart movement of a distal portion, such as with pushing the pushingmember 132. For example, when pushing the packingmember 130 with the pushingmember 132, the operator can manipulate such longer embodiments of the pushingmember 132 from outside of the patient, with tactile feedback indicated passage of the packingmember 130 and/or the lockingmember 222 past theprotrusion 224 of theelongated body 200. - Variations of the above described embodiments, as will be apparent to one of ordinary skill in the art, are contemplated by the present disclosure.
- One method of use of
system 100 will now be described with respect to closing and repairing an opening in a wall of a blood vessel. As noted previously, it is to be understood that similar usages can be made in other body tissues (e.g., bile or other ducts), or other vessels, conduits or walls. For example, in use with fistulae (e.g., vescio-vaginal fistula), seal(s) as described herein may be placed and held over fistula openings and against tissue substantially as described below, with packing members within the fistula to assist with healing or correction of the fistula. - Reference to the following exemplary method of use will be made with regard to a
vessel 1006 positioned beneathtissue 1000 such asskin 1002 and/or muscle/fat 1004 of the body of a patient. Thevessel 1006 comprises avessel wall 1008 having aninner surface 1010, anouter surface 1012, and the inner surface defining alumen 1014 extending through thevessel 1006. - A surgeon or other medical professional performs and completes desired procedure(s) that involve access to the
blood vessel 1006 throughhole 1016 in wall 1008 (e.g., balloon catheterization or stenting procedures). If a sheath, cannula or other access device or portal was used for the procedure(s), it can be left in thevessel 1006, and thesystem 100 described above may be inserted through it. If no such access device is present, or if a change of access device is necessary or desired,outer sheath 240 is placed in the opening by using a dilator with an introducer sheath so that thedistal end 244 is inside thevessel 1006.Seal member 254 may provide a barrier preventing blood from exiting thelumen 252 of theouter sheath 240 from theproximal end region 242. - As illustrated in
FIG. 24 , after access is gained to thelumen 1014 of thevessel 1006 within the body of the patient and thevessel 1006 has been used to provide therapy and/or for diagnostic purposes, thesystem 100, prepared as noted above, is inserted into thelumen 252 of theouter sheath 240 and advanced towards thevessel 1006. As theouter surface 120 of theintroducer 110 slides along theinner surface 248 defining thelumen 252, thedistal surface 128 of theflange 124 of theintroducer 110 contacts a portion of theproximal end region 242 of theouter sheath 240 and prevents further insertion of theintroducer 110 within thelumen 252 of the outer sheath 240 (FIG. 24 ). - If the
introducer 110 is shorter in length than theouter sheath 240, theinsertion sheath 140, theelongated body 200 and the vascular closure device are advanced through thelumen 122 of theintroducer 110 so as to position thevascular closure device 230 and/or portions of theinsertion sheath 140 and/or theelongated body 200 within thelumen 252 of theouter sheath 240. Theinsertion sheath 140 is advanced further so as to position thevascular closure device 230 within thelumen 1014 of thevessel 1006, allowing thevascular closure device 230 to expand into an expanded configuration within the lumen 1014 (seeFIG. 26 ). After thevascular closure device 230 has expanded into an expanded configuration, the resistingmember 160,elongated body 200,insertion sheath 140,introducer 110, and/orouter sheath 240 are/is be withdrawn. - As shown in
FIG. 27 , as the resistingmember 160,insertion sheath 140,introducer 110, and/orouter sheath 240 are being withdrawn, the resistingmember 160 contacts the outer surface of theelongated body 200 in thelow resistance portion 208 and imparts a resistive force onto theelongated body 200. The resistive force withdraws theelongated body 200 from thevessel 1006 so as to pull thevascular closure device 230 against theinner surface 1010 of thevessel wall 1008 thereby coveringhole 1016 - As
vascular closure device 230 contacts theinner surface 1010 of thevessel wall 1008, the resistingmember 160 slides along theelongated body 200. As the resistingmember 160 slides from thelow resistance portion 208 into thehigher resistance portion 206 of theproximal end region 202, the force exerted to thevascular closure device 230 by theelongated body 200 increases to at least a conforming force but less than a deforming force, so as to conform thevascular closure device 230 to theinner surface 1010 of thevessel wall 1008, as shown inFIG. 28 . - As illustrated in
FIGS. 29 and 30 , the operator continues to withdraw theinsertion sheath 140,introducer 110 and/or theouter sheath 240 along the length of theelongated body 200 such thatadditional protrusions 210 of thehigh resistance portion 206 are moved through the resistingmember 160. As the operator pulls on theouter sheath 240,introducer 110 and/or theinsertion sheath 140 over theprotrusions 210, an amount of force between the conforming force and deforming force is being applied through theelongated body 200 to thevascular closure device 230. At this time the operator advances a packingmember 130 towards thehole 1016 in thevessel wall 1008 by pushing on a pushingmember 132 along a length of theelongated body 200. When the operator is pleased with the positioning of the packingmember 130, such as when the packingmember 130 is coupled to thevessel 1006 by a lockingmember 222, the operator severs a portion of theelongated body 200 so as to leave thevascular closure device 230 in position against theinner surface 1010 of thevessel wall 1008 with the packingmember 130 positioned against theouter surface 1012 of thevessel wall 1008 and a portion of theelongated body 200 in tensions between thevascular closure device 230 and the packingmember 130. In this configuration, the portion of theelongated body 200 left in situ exerts a conforming force to thevascular closure device 230 and the packingmember 130 so as to substantially occlude the hole in the vessel wall. - In some embodiments, the
high resistance portion 206 of theelongated body 200, such as aprotrusion 210, is constructed and arranged to compensate for the force exerted by the pushingmember 132 to push the packingmember 130 against thevessel wall 1008. In other words, the interaction between the resistingmember 160 and thehigh resistance portion 206 is such that even when the operator is applying an opposing force to portions of thesystem 100 to secure the packingmember 130 against thevessel wall 1008, thedistal end 204 of theelongated body 200 still applies at least a conforming force to thevascular closure device 230. - While other devices rely on a clot forming at the opening in the wall of the vessel, and thus result in substantial oozing from the opening while a clot is forming, embodiments such as those noted above cover the inside of the opening. Closure is maintained by tension on the seal, and by deforming the seal so that a portion of it is held against the vessel by the reaction of the seal to the deformation.
- While the subject matter herein has been illustrated and described in detail in the exemplary drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment(s) have been shown and described and that all changes and modifications that come within the spirit of the disclosure are desired to be protected. It will be understood that structures, methods or other features described particularly with one embodiment can be similarly used or incorporated in or with respect to other embodiments.
Claims (20)
1. An apparatus coupled to a vascular closure device, the apparatus being constructed and arranged to interact with a resisting member comprising a grip portion to apply a force to the vascular closure device to substantially occlude a hole in a vessel wall, the apparatus comprising:
an elongated body comprising a proximal end region, a distal end region, a high-resistance portion positioned adjacent to said proximal end region, and a low-resistance portion positioned adjacent to said distal end region;
wherein said distal end region is coupled to the vascular closure device;
wherein said elongated body is constructed and arranged to slidably couple with and contact the resisting member so as to cause a resistive force between said elongated body and the resisting member; and
wherein said high-resistance portion and said low-resistance portion are constructed and arranged such that the resistive force between said high-resistance portion and said resisting member is greater than the resistive force between said low-resistance portion and said resisting member.
2. The apparatus of claim 1 , wherein said high-resistance portion is constructed and arranged to interface with the resisting member such that the resistance-resistive force is greater than a conforming force.
3. The apparatus of claim 1 , wherein said low-resistance portion is constructed and arranged to interface with the resisting member such that the resistive force is greater than a conforming force.
4. The apparatus of claim 3 , wherein said resisting member and said high-resistance portion are constructed and arranged such that the resistive force is less than a deforming force.
5. The apparatus of claim 1 , wherein said high-resistance portion defines a large diameter portion and said low-resistance portion defines a small diameter portion.
6. The apparatus of claim 1 , further comprising:
a taper on said elongated body.
7. The apparatus of claim 1 , further comprising:
a shoulder on said elongated body.
8. The apparatus of claim 1 , wherein said high-resistance portion defines a plurality of large-diameter portions separated by small-diameter portions along a length of said elongated body.
9. The apparatus of claim 1 , further comprising:
a stop member positioned at the proximal end region of said elongated body.
10. The apparatus of claim 1 , wherein said high-resistance portion comprises a surface that has an average surface roughness greater than that of said low-resistance portion.
11. A system arranged to conform a vascular closure device over a hole in a vessel wall to occlude the hole, the system comprising:
an elongated body comprising a proximal end region, a distal end region, a high-resistance portion positioned adjacent to said proximal end region, and a low-resistance portion positioned adjacent to said distal end region;
wherein said distal end region is coupled to the vascular closure device; and
a resisting member comprising a grip portion constructed and arranged to slidably couple with and to contact said elongated body thereby generating a resistive force that resists relative longitudinal movement between the elongated body and the resisting member;
wherein said high-resistance portion, said low-resistance portion, and said resisting member are constructed and arranged such that the resistive force between said high-resistance portion and said resisting member is greater than the resistive force between said low-resistance portion and said resisting member.
12. The system of claim 11 , wherein said resisting member comprises a sheath.
13. The system of claim 11 , wherein said resisting member comprises a valve.
14. The system of claim 11 , wherein said resisting member comprises a channel arranged to receive said elongated body, wherein said channel changes directions along at least one axis.
15. The system of claim 11 , wherein said resisting member comprises a spring-loaded friction system comprising a first surface, a second surface, and a spring member biasing said first surface towards said second surface.
16. A system arranged to conform a vascular closure device over a hole in a vessel wall to occlude the hole, the system comprising:
an elongated body comprising a proximal end region and a distal end region;
said distal end region coupled to the vascular closure device; and
a resisting member comprising a grip portion and constructed and arranged to slidably couple with and contact said elongated body, wherein the grip portion is constructed and arranged for an operator to apply a force to;
wherein said elongated body and said resisting member are constructed and arranged to interface and to generate a resistive force that resists relative longitudinal movement between the elongated body and the resisting member;
wherein said elongated body and said resisting member are constructed and arranged to generate a maximum static resistive force during a non-sliding condition and a maximum dynamic resistive force during a sliding condition; and
wherein the maximum static resistive force is greater than a conforming force sufficient to occlude the hole and is less than a deforming force of the vascular closure device.
17. The system of claim 16 , wherein the maximum dynamic resistive force is greater than a conforming force sufficient to occlude the hole.
18. The system of claim 16 , wherein the maximum dynamic resistive force is less than a deforming force of the vascular closure device.
19. The system of claim 16 , wherein said elongated body and said resisting member are constructed and arranged to interface such that the maximum resistive force is variable.
20. The system of claim 16 , wherein said elongated body and said resisting member are constructed and arranged to interface such that the maximum dynamic resistive force is variable.
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Cited By (2)
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US20140222064A1 (en) * | 2013-02-01 | 2014-08-07 | St. Jude Medical Puerto Rico Llc | Dual lumen carrier tube with retractable sleeve and methods |
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2017
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Cited By (5)
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US20140222064A1 (en) * | 2013-02-01 | 2014-08-07 | St. Jude Medical Puerto Rico Llc | Dual lumen carrier tube with retractable sleeve and methods |
US9131932B2 (en) * | 2013-02-01 | 2015-09-15 | St. Jude Medical Puerto Rico Llc | Dual lumen carrier tube with retractable sleeve and methods |
US20160228109A1 (en) * | 2015-02-10 | 2016-08-11 | Vascular Solution, Inc. | Closure device for sealing percutaneous opening in a vessel |
US10016188B2 (en) * | 2015-02-10 | 2018-07-10 | Teleflex Innovation S.à.r.l. | Closure device for sealing percutaneous opening in a vessel |
US10722225B2 (en) | 2015-02-10 | 2020-07-28 | Teleflex Life Sciences Limited | Closure device for sealing percutaneous opening in a vessel |
Also Published As
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US20170215853A1 (en) | 2017-08-03 |
US10849607B2 (en) | 2020-12-01 |
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