CA2588152A1 - Rotational thrombectomy wire - Google Patents
Rotational thrombectomy wire Download PDFInfo
- Publication number
- CA2588152A1 CA2588152A1 CA002588152A CA2588152A CA2588152A1 CA 2588152 A1 CA2588152 A1 CA 2588152A1 CA 002588152 A CA002588152 A CA 002588152A CA 2588152 A CA2588152 A CA 2588152A CA 2588152 A1 CA2588152 A1 CA 2588152A1
- Authority
- CA
- Canada
- Prior art keywords
- wire
- inner core
- thrombectomy
- sinuous
- multifilar
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00867—Material properties shape memory effect
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B2017/320733—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09058—Basic structures of guide wires
- A61M2025/09083—Basic structures of guide wires having a coil around a core
Abstract
A rotatable thrombectomy wire for breaking up thrombus or other obstructive material comprising an inner core composed of a flexible material and an outer wire surrounding at least a portion of the inner core. The outer wire has a sinuous shaped portion at a distal region. The inner core limits the compressibility of the outer wire. The outer wire is operatively connectable at a proximal end to a motor for rotating the wire to macerate thrombus.
Description
ROTATIONAL THROMBECTOMY WIRE
BACKGROUND
This application claims priority from provisional application serial number 60/628,623, filed November 17, 2004, the entire contents of which are incorporated herein by reference.
Technical Field This application relates to a rotational thrombectomy wire for clearing thrombus from native vessels.
Background of Related Art In one method of hemodialysis, dialysis grafts, typically of PTFE, are implanted under the patient's skin, e.g. the patient's forearm, and sutured at one end to the vein for outflow and at the other end to the artery for inflow. The graft functions as a shunt creating high blood flow from the artery to the vein and enables access to the patient's blood without having to directly puncture the vein. (Repeated puncture of the vein could eventually damage the vein and cause blood clots, resulting in vein failure.) One needle is inserted into the graft to withdraw blood from the patient. for transport to a dialysis machine (kidney machine); the other needle is inserted into the graft to return the filtered blood from the dialysis machine to the patient. In the dialysis machine, toxins and other waste products diffuse through a semi-permeable membrane into a dialysis fluid closely matching the chemical composition of the blood. The filtered blood, i.e. with the waste products removed, is then returned to the patient's body.
Over a period of time, thrombus or clots may form in the graft. Thrombus or clots may also form in the vessel. One approach to break up these clots and other obstructions in the graft, and vessel is the injection of thrombolytic agents. The disadvantages of these agents are they are expensive, require lengthier hospital procedures and create risks of drug toxicity and bleeding complications as the clots are broken.
U.S. Patent No. 5,766,191 provides another approach to breaking up clots and obstructions via a mechanical thrombectomy device. The patent discloses a basket having six memory wires expandable to press against the inner lumen to conform to the size and shape of the lumen. This device could be traumatic if used in the vessel, could denude endothelium, create vessel spasms and the basket and drive shaft could fracture.
U.S. Patent No. 6,090,118 discloses a mechanical thrombectomy device for breaking up clots. The single thrombectomy wire is rotated to create a standing wave to break-up or macerate thrombus. U.S. Patent Publication No. 2002/0173812 discloses another example of a rotational thrombectomy wire for breaking up clots. The thrombectomy wire has a sinuous shape at its distal end and is contained within a sheath in a substantially straight non-deployed position. When the sheath is retracted, the distal portion of the wire is exposed to enable the wire to return to its non-linear sinuous configuration. The wire is composed of stainless steel. Actuation of the motor causes rotational movement of the wire, creating a wave pattern, to macerate thrombus. The device of the '812 patent publication is effective in atraumatically and effectively breaking up blood clots in the grafl and is currently being marketed by Datascope, Inc. as the Pro-Lumen* thrombectomy catheter. In the marketed device, the wire is a bifilar wire, composed of two stainless steel wires wound side by side with a metal tip and an elastomeric tip at the distalmost end.
Although the sinuous wire of the '812 publication is effective in proper clinical use to macerate thrombus in dialysis grafts, it is not suited for use in native vessels. The device is indicated for use in grafts, and if improperly used the wire can kink or knot, and perhaps even break. The wire can also bend, making it difficult to withdraw after use, and can lose its shape. Additionally, the wire would be abrasive to the vessel and the vessel could get caught in the interstices of the wire. It could also cause vessels spasms which can cause the vessel to squeeze down on the wire which could break the wire.
Similar problems would occur with the use of the device of the '118 patent in native vessels.
The need therefore exists for a rotational thrombectomy wire which can be used to clear clots or other obstructions from the native vessels. Such wire could advantageously be used not only in native vessels adjacent dialysis grafts but for deep vein thrombosis and pulmonary embolisms.
BACKGROUND
This application claims priority from provisional application serial number 60/628,623, filed November 17, 2004, the entire contents of which are incorporated herein by reference.
Technical Field This application relates to a rotational thrombectomy wire for clearing thrombus from native vessels.
Background of Related Art In one method of hemodialysis, dialysis grafts, typically of PTFE, are implanted under the patient's skin, e.g. the patient's forearm, and sutured at one end to the vein for outflow and at the other end to the artery for inflow. The graft functions as a shunt creating high blood flow from the artery to the vein and enables access to the patient's blood without having to directly puncture the vein. (Repeated puncture of the vein could eventually damage the vein and cause blood clots, resulting in vein failure.) One needle is inserted into the graft to withdraw blood from the patient. for transport to a dialysis machine (kidney machine); the other needle is inserted into the graft to return the filtered blood from the dialysis machine to the patient. In the dialysis machine, toxins and other waste products diffuse through a semi-permeable membrane into a dialysis fluid closely matching the chemical composition of the blood. The filtered blood, i.e. with the waste products removed, is then returned to the patient's body.
Over a period of time, thrombus or clots may form in the graft. Thrombus or clots may also form in the vessel. One approach to break up these clots and other obstructions in the graft, and vessel is the injection of thrombolytic agents. The disadvantages of these agents are they are expensive, require lengthier hospital procedures and create risks of drug toxicity and bleeding complications as the clots are broken.
U.S. Patent No. 5,766,191 provides another approach to breaking up clots and obstructions via a mechanical thrombectomy device. The patent discloses a basket having six memory wires expandable to press against the inner lumen to conform to the size and shape of the lumen. This device could be traumatic if used in the vessel, could denude endothelium, create vessel spasms and the basket and drive shaft could fracture.
U.S. Patent No. 6,090,118 discloses a mechanical thrombectomy device for breaking up clots. The single thrombectomy wire is rotated to create a standing wave to break-up or macerate thrombus. U.S. Patent Publication No. 2002/0173812 discloses another example of a rotational thrombectomy wire for breaking up clots. The thrombectomy wire has a sinuous shape at its distal end and is contained within a sheath in a substantially straight non-deployed position. When the sheath is retracted, the distal portion of the wire is exposed to enable the wire to return to its non-linear sinuous configuration. The wire is composed of stainless steel. Actuation of the motor causes rotational movement of the wire, creating a wave pattern, to macerate thrombus. The device of the '812 patent publication is effective in atraumatically and effectively breaking up blood clots in the grafl and is currently being marketed by Datascope, Inc. as the Pro-Lumen* thrombectomy catheter. In the marketed device, the wire is a bifilar wire, composed of two stainless steel wires wound side by side with a metal tip and an elastomeric tip at the distalmost end.
Although the sinuous wire of the '812 publication is effective in proper clinical use to macerate thrombus in dialysis grafts, it is not suited for use in native vessels. The device is indicated for use in grafts, and if improperly used the wire can kink or knot, and perhaps even break. The wire can also bend, making it difficult to withdraw after use, and can lose its shape. Additionally, the wire would be abrasive to the vessel and the vessel could get caught in the interstices of the wire. It could also cause vessels spasms which can cause the vessel to squeeze down on the wire which could break the wire.
Similar problems would occur with the use of the device of the '118 patent in native vessels.
The need therefore exists for a rotational thrombectomy wire which can be used to clear clots or other obstructions from the native vessels. Such wire could advantageously be used not only in native vessels adjacent dialysis grafts but for deep vein thrombosis and pulmonary embolisms.
2 SUMMARY
The present invention advantageously provides a rotational thrombectomy wire for breaking up thrombus or other obstructive material in a lumen of a native vessel.
The present invention provides a rotational thrombectomy wire comprising an inner core composed of a flexible material and a multifilar outer wire surrounding at least a portion of the inner core. The outer wire includes at least first and second metal wires wound side by side and having a sinuous shaped portion at a distal region. The inner core at a distal portion has a sinuous shaped portion within the sinuous portion of the outer wire. The inner core limits the compressibility of the multifilar wire. The multifilar wire is operatively connectable at a proximal end to a motor for rotating the wire to macerate thrombus within the vessel.
In a preferred embodiment, the inner core is composed of nylon material. In another embodiment, the inner core is composed of shape memory material wherein the inner core assumes its sinuous shape in the memorized configuration. In another embodiment, the core comprises at least two twisted wires of stainless steel.
The thrombectomy wire preferably further includes a polymeric material surrounding at least a distal portion of the multifilar wire. In a preferred embodiment, the polymeric material comprises a shrink wrap material attached to the multifilar wire. In another embodiment, the polymeric material is a coating over the multifilar wire.
The thrombectomy wire preferably comprises a flexible and blunt tip positioned at a distal end.
The inner core can have in one embodiment an enlarged distal end to form a connection portion and a metal tip secured to a distal end of the multifilar wire has a recess to receive the enlarged end of the inner core to frictionally engage the inner core.
In one embodiment, the first and second metal wires are wound together such that the coils of the first wire occupy the space between adjacent turns of the second wire and the coils of the multifilar outer wire have an inner diameter approximately equal to an outer diameter of the inner core.
The present invention also provides a rotatable thrombectomy wire for breaking up thrombus or other obstructive material in a lumen of a vessel comprising a multifilar outer wire including at least two metal wires wound side by side and operatively
The present invention advantageously provides a rotational thrombectomy wire for breaking up thrombus or other obstructive material in a lumen of a native vessel.
The present invention provides a rotational thrombectomy wire comprising an inner core composed of a flexible material and a multifilar outer wire surrounding at least a portion of the inner core. The outer wire includes at least first and second metal wires wound side by side and having a sinuous shaped portion at a distal region. The inner core at a distal portion has a sinuous shaped portion within the sinuous portion of the outer wire. The inner core limits the compressibility of the multifilar wire. The multifilar wire is operatively connectable at a proximal end to a motor for rotating the wire to macerate thrombus within the vessel.
In a preferred embodiment, the inner core is composed of nylon material. In another embodiment, the inner core is composed of shape memory material wherein the inner core assumes its sinuous shape in the memorized configuration. In another embodiment, the core comprises at least two twisted wires of stainless steel.
The thrombectomy wire preferably further includes a polymeric material surrounding at least a distal portion of the multifilar wire. In a preferred embodiment, the polymeric material comprises a shrink wrap material attached to the multifilar wire. In another embodiment, the polymeric material is a coating over the multifilar wire.
The thrombectomy wire preferably comprises a flexible and blunt tip positioned at a distal end.
The inner core can have in one embodiment an enlarged distal end to form a connection portion and a metal tip secured to a distal end of the multifilar wire has a recess to receive the enlarged end of the inner core to frictionally engage the inner core.
In one embodiment, the first and second metal wires are wound together such that the coils of the first wire occupy the space between adjacent turns of the second wire and the coils of the multifilar outer wire have an inner diameter approximately equal to an outer diameter of the inner core.
The present invention also provides a rotatable thrombectomy wire for breaking up thrombus or other obstructive material in a lumen of a vessel comprising a multifilar outer wire including at least two metal wires wound side by side and operatively
3 connectable at a proximal end to a motor for rotating the wire to macerate thrombus. The multifilar wire has a sinuous shaped portion at a distal region. A polymeric material surrounds at least a region of the sinuous portion of the multifilar outer wire to block the interstices of the multifilar wire.
In a preferred embodiment, the polymeric material comprises a shrink wrap material. In another embodiment, the polymeric material is a coating over the bifilar wire.
The present invention also provides a thrombectomy apparatus for breaking up thrombus or other obstructive material comprising a handle, a sheath, a battery, a motor powered by the battery, and a sinuous thrombectomy wire having at least one wire wound to form a coil and an inner core composed of a material to limit the compressibility of the coil. The coil has a sinuous portion and surrounds at least a distal region of the inner core. The inner core has a sinuous portion within the sinuous portion of the coil. The sinuous portion of the inner core and first and second wires are movable from a straighter configuration within the sheath for delivery to a sinuous configuration when exposed from the sheath.
In a preferred embodiment, a polymeric material surrounds at least a distal portion of the coil to cover the interstices of the coil. In one embodiment, the core is composed of a shape memory material wherein the memorized position of the core has a sinuous configuration. In another embodiment, the core is composed of Nylon. In another embodiment, the core is composed of at least two twisted wires of stainless steel.
The present invention also provides a method for breaking up thrombus or other obstructive material in a native vessel comprising:
providing a thrombectomy wire having an inner core composed of a flexible material and at least one outer wire surrounding at least a portion of the inner core, the outer wire has a sinuous shaped portion at a distal region and the inner core has a sinuous shaped portion within the sinuous portion of the outer wire, and a polymeric material surrounding at least a distal portion of the at least one outer wire to block the interstices of the at least one outer wire;
In a preferred embodiment, the polymeric material comprises a shrink wrap material. In another embodiment, the polymeric material is a coating over the bifilar wire.
The present invention also provides a thrombectomy apparatus for breaking up thrombus or other obstructive material comprising a handle, a sheath, a battery, a motor powered by the battery, and a sinuous thrombectomy wire having at least one wire wound to form a coil and an inner core composed of a material to limit the compressibility of the coil. The coil has a sinuous portion and surrounds at least a distal region of the inner core. The inner core has a sinuous portion within the sinuous portion of the coil. The sinuous portion of the inner core and first and second wires are movable from a straighter configuration within the sheath for delivery to a sinuous configuration when exposed from the sheath.
In a preferred embodiment, a polymeric material surrounds at least a distal portion of the coil to cover the interstices of the coil. In one embodiment, the core is composed of a shape memory material wherein the memorized position of the core has a sinuous configuration. In another embodiment, the core is composed of Nylon. In another embodiment, the core is composed of at least two twisted wires of stainless steel.
The present invention also provides a method for breaking up thrombus or other obstructive material in a native vessel comprising:
providing a thrombectomy wire having an inner core composed of a flexible material and at least one outer wire surrounding at least a portion of the inner core, the outer wire has a sinuous shaped portion at a distal region and the inner core has a sinuous shaped portion within the sinuous portion of the outer wire, and a polymeric material surrounding at least a distal portion of the at least one outer wire to block the interstices of the at least one outer wire;
4
5 PCT/US2005/039856 delivering the wire to the lumen of the native vessel such that the sinuous shaped portions of the inner core and bifilar outer wire are in a more linear configuration within a sheath;
exposing the sinuous portion of the inner core and the at least one outer wire; and actuating a motor operatively connected to the thrombectomy wire so the sinuous portion of the at least one outer wire contacts the inner wall of the native vessel to macerate thrombus in the vessel.
BRIEF DESCRIPTION OF THE DRAWINGS
Preferred embodiment(s) of the present disclosure are described herein with reference to the drawings wherein:
Figure 1 is a side view in partial cross-section of a first embodiment of a thrombectomy wire of the present invention shown inside a catheter sleeve for delivery;
Figure 2 is a schematic view illustrating motorized rotation of the wire and a port for fluid delivery;
Figure 3 is a schematic side elevational view of the sinuous portion of the thrombectomy wire to depict a first embodiment of the inner core positioned therein;
Figure 4 is an enlarged cross-sectional view of the distalmost region of the rotational thrombectomy wire of Figure 3;
Figure 5 is schematic side elevational view of the sinuous portion of the thrombectomy wire to depict a second embodiment of the inner core positioned therein;
and Figure 6 is an enlarged side view of the distalmost region of the rotational wire of Figure 5;
Figure 7 is a schematic side elevational view of the sinuous portion of the thrombectomy wire to depict a third embodiment of the inner core positioned therein; and Figure 8 is a cross-sectional view taken along line 8-8 of Figure 7.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
Referring now in detail to the drawings where like reference numerals identify similar or like components throughout the several views, Figures 3 and 4 illustrate a first embodiment of the thrombectomy wire of the present invention. The thrombectomy wire, designated generally by reference numeral 10, includes a core 20, a bifilar wire (coil) 30, and shrink wrap 50. The bifilar wire 30 is formed by two stainless steel wires 32, 34, wound together. As shown they are wound side by side so the cross-sectional area or diameter "a" of the wire fills the space between adjacent turns of the other wire.
For example, turns 32a and 32b are filled by respective turns 34a, 34b as shown.
Preferably the bifilar wire 30 has a length of about 30 inches and a diameter of about .030 inches to about .040 inches and more preferably about .035 inches. When used in deeper native vessels, e.g. deep veins of the legs or pulmonary circuit, the wire 30 can have a length of about 52 inches. Other dimensions are also contemplated.
The distal region 16 of the bifilar wire 30 is formed into a sinuous or s-shape to contact the vessel wall as the wire rotates.
Although in the preferred illustrated and described embodiments, the outer wire is a multifilar wire in the form of a bifilar wire (two wires), a different number of wires could be wound to form the outer wire component of the thrombectomy wire of the present invention. In yet another embodiment the outer wire can comprise a single wound wire.
The bifilar wire 30 is preferably cold formed into an over-formed s-shape. The bifilar wire is heated, for example at about 670 degrees Fahrenheit, which removes residual stresses and changes the shape of the "s" so it warps back to its desired shape.
This stress relief process makes the wire more dimensionally stable.
A tip 80, preferably composed of rubber, Pebax, or other elastomeric materials, is mounted at the distalmost tip of the wire 10 to provide the wire 10 with an atraumatic distal tip to prevent damage to the vessel wall during manipulation and rotation of the wire. A metal tip 60 is attached by laser welding or other methods to the distal end of the bifilar wire 30. The metal tip 60 has an enlarged dumbbell shaped head 62 to facilitate attachment to tip 80. The flexible tip 80 is attached by injection molding over the machined tip. Other attachment methods are also contemplated.
With continued reference to Figure 4, a core 20 is positioned within the bifilar wire 30 and preferably has an outer diameter E substantially equal to the inner diameter D of the coil. The core at a distal portion has a sinuous shaped portion within the sinuous shaped portion of the outer wire 30, corresponding to and formed by the sinuous shape of outer wire 30. In one embodiment, the core extends the entire length of the bifilar wire
exposing the sinuous portion of the inner core and the at least one outer wire; and actuating a motor operatively connected to the thrombectomy wire so the sinuous portion of the at least one outer wire contacts the inner wall of the native vessel to macerate thrombus in the vessel.
BRIEF DESCRIPTION OF THE DRAWINGS
Preferred embodiment(s) of the present disclosure are described herein with reference to the drawings wherein:
Figure 1 is a side view in partial cross-section of a first embodiment of a thrombectomy wire of the present invention shown inside a catheter sleeve for delivery;
Figure 2 is a schematic view illustrating motorized rotation of the wire and a port for fluid delivery;
Figure 3 is a schematic side elevational view of the sinuous portion of the thrombectomy wire to depict a first embodiment of the inner core positioned therein;
Figure 4 is an enlarged cross-sectional view of the distalmost region of the rotational thrombectomy wire of Figure 3;
Figure 5 is schematic side elevational view of the sinuous portion of the thrombectomy wire to depict a second embodiment of the inner core positioned therein;
and Figure 6 is an enlarged side view of the distalmost region of the rotational wire of Figure 5;
Figure 7 is a schematic side elevational view of the sinuous portion of the thrombectomy wire to depict a third embodiment of the inner core positioned therein; and Figure 8 is a cross-sectional view taken along line 8-8 of Figure 7.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
Referring now in detail to the drawings where like reference numerals identify similar or like components throughout the several views, Figures 3 and 4 illustrate a first embodiment of the thrombectomy wire of the present invention. The thrombectomy wire, designated generally by reference numeral 10, includes a core 20, a bifilar wire (coil) 30, and shrink wrap 50. The bifilar wire 30 is formed by two stainless steel wires 32, 34, wound together. As shown they are wound side by side so the cross-sectional area or diameter "a" of the wire fills the space between adjacent turns of the other wire.
For example, turns 32a and 32b are filled by respective turns 34a, 34b as shown.
Preferably the bifilar wire 30 has a length of about 30 inches and a diameter of about .030 inches to about .040 inches and more preferably about .035 inches. When used in deeper native vessels, e.g. deep veins of the legs or pulmonary circuit, the wire 30 can have a length of about 52 inches. Other dimensions are also contemplated.
The distal region 16 of the bifilar wire 30 is formed into a sinuous or s-shape to contact the vessel wall as the wire rotates.
Although in the preferred illustrated and described embodiments, the outer wire is a multifilar wire in the form of a bifilar wire (two wires), a different number of wires could be wound to form the outer wire component of the thrombectomy wire of the present invention. In yet another embodiment the outer wire can comprise a single wound wire.
The bifilar wire 30 is preferably cold formed into an over-formed s-shape. The bifilar wire is heated, for example at about 670 degrees Fahrenheit, which removes residual stresses and changes the shape of the "s" so it warps back to its desired shape.
This stress relief process makes the wire more dimensionally stable.
A tip 80, preferably composed of rubber, Pebax, or other elastomeric materials, is mounted at the distalmost tip of the wire 10 to provide the wire 10 with an atraumatic distal tip to prevent damage to the vessel wall during manipulation and rotation of the wire. A metal tip 60 is attached by laser welding or other methods to the distal end of the bifilar wire 30. The metal tip 60 has an enlarged dumbbell shaped head 62 to facilitate attachment to tip 80. The flexible tip 80 is attached by injection molding over the machined tip. Other attachment methods are also contemplated.
With continued reference to Figure 4, a core 20 is positioned within the bifilar wire 30 and preferably has an outer diameter E substantially equal to the inner diameter D of the coil. The core at a distal portion has a sinuous shaped portion within the sinuous shaped portion of the outer wire 30, corresponding to and formed by the sinuous shape of outer wire 30. In one embodiment, the core extends the entire length of the bifilar wire
6 30 and this is shown in the schematic drawing of Figure 3. The core 20 can alternatively have a length of about 4-5 inches so it extends through the distal linear portion and sinuous portion of the wire 30. That is, in such embodiment, the core extends through the portion of the wire that is exposed from the sheath and used to macerate thrombus. It is also contemplated that the core can extend within a shorter or longer length of the bifilar wire.
The core 20 is composed of a flexible material which will limit the compressibility of the wire 30 during use. The core in the embodiment of Figure 3 is composed of Nylon, and preferably a drawn Nylon monofilament. Other possible materials include, for example, Teflon, polypropylene, PET, and fluorocarbon.
The Nylon provides a non-compressible material to limit the compressibility of the wire 30 during use. That is, as noted above, the Nylon core preferably has a diameter E to fill the inside of the coil 30, e.g. a diameter of about .008 inches to about .013 inches, and preferably about .012 inches. (Other dimensions are also contemplated.) This enables the coil (bifilar wire) 30 to compress only to that diameter. By limiting compressibility it strengthens the wire as it reduces its degree of elongation if it is under torque. It also prevents bending or knotting of the wire which could otherwise occur in native vessels.
It increases the torsional strength of the wire and also strengthens the wire to accommodate spasms occurring in the vessel. An enlarged distal head, such as ball tip (not shown), can be provided on the core 20 to fit in a recess of machined tip 60. As an alternative, core 20 can be attached by adhesive at the tip, welded, crimped, soldered or can alternatively be free floating.
The shrink wrap material 50 covers a portion of the bifilar wire 30 proximal of the flexible tip 80 to block the interstices of the coil and provide a less abrasive surface. As shown in Figure 4, the distal end of the shrink wrap abuts the proximal end of the tip 60.
The shrink wrap can be made of PET, Teflon, Pebax, polyurethane or other polymeric materials. The material extends over the exposed portion of the wire 30 (preferably for about 3 inches to about 4 inches) and helps to prevent the native vessel from being caught in the coil and reduces vessel spasms. Alternatively, instead of shrink wrap, a coating can be applied to the coil formed by the bifilar wire to cover the interstices
The core 20 is composed of a flexible material which will limit the compressibility of the wire 30 during use. The core in the embodiment of Figure 3 is composed of Nylon, and preferably a drawn Nylon monofilament. Other possible materials include, for example, Teflon, polypropylene, PET, and fluorocarbon.
The Nylon provides a non-compressible material to limit the compressibility of the wire 30 during use. That is, as noted above, the Nylon core preferably has a diameter E to fill the inside of the coil 30, e.g. a diameter of about .008 inches to about .013 inches, and preferably about .012 inches. (Other dimensions are also contemplated.) This enables the coil (bifilar wire) 30 to compress only to that diameter. By limiting compressibility it strengthens the wire as it reduces its degree of elongation if it is under torque. It also prevents bending or knotting of the wire which could otherwise occur in native vessels.
It increases the torsional strength of the wire and also strengthens the wire to accommodate spasms occurring in the vessel. An enlarged distal head, such as ball tip (not shown), can be provided on the core 20 to fit in a recess of machined tip 60. As an alternative, core 20 can be attached by adhesive at the tip, welded, crimped, soldered or can alternatively be free floating.
The shrink wrap material 50 covers a portion of the bifilar wire 30 proximal of the flexible tip 80 to block the interstices of the coil and provide a less abrasive surface. As shown in Figure 4, the distal end of the shrink wrap abuts the proximal end of the tip 60.
The shrink wrap can be made of PET, Teflon, Pebax, polyurethane or other polymeric materials. The material extends over the exposed portion of the wire 30 (preferably for about 3 inches to about 4 inches) and helps to prevent the native vessel from being caught in the coil and reduces vessel spasms. Alternatively, instead of shrink wrap, a coating can be applied to the coil formed by the bifilar wire to cover the interstices
7 Figures 5 and 6 illustrate an alternate embodiment of the thrombectomy wire of the present invention, designated generally by reference numeral 100. Wire 100 is identical to wire 10 of Figure 1, except for the inner core 120. It is identical in that it has a bifilar wire 130, a shrink wrap 170, an elastomeric tip 180 and metal, e.g.
stainless steel, tip 160.
In this embodiment, the core 120 is composed of a shape memory material, preferably Nitinol (a nickel titanium alloy), which has a memorized configuration of a sinuous or s-shape substantially corresponding to the s-shape of the bifilar wire 130. In the softer martensitic state within the sheath, core 120 is in a substantially linear configuration. This state is used for delivering the wire to the surgical site. When the wire is exposed to warmer body temperature, the core 120 transforms to its austenitic state, assuming the s-shaped memorized configuration. Cold saline is delivered through the catheter during delivery to maintain the core 120 in this martensitic state; the warming occurs by exposure to body temperature to transform the core 120 to the memorized state. Such memorized s-shape helps maintain the s-shape of the bifilar wire 130 during use. Cold saline can also be delivered to the core 120 at the end of the procedure to facilitate withdrawal.
The Nitinol core 120, like the Nylon core 20, is not compressible so it will also limit the compressibility of the bifilar wire 130. The Nitinol core 120 also will increase the stiffness of the wire 100, thereby reducing the chance of knotting and kinking and increase the strength of the wire to accommodate any spasms in the vessel. Its shape memory helps hold the amplitude of the bifilar wire 130 during use to maintain its force against the clot for maceration upon rotation. It preferably extends about 4-5 inches so it extends through the distal linear portion and sinuous portion of the wire 130, terminating at end 122. Alternately it can extend a shorter or longer length within the wire 130, or even the entire length as shown in the schematic view of Figure 5. It preferably has an outer diameter of about .008 inches to about .013 inches, and more preferably about .012 inches, corresponding to the inner diameter of the coil. Other dimensions are also contemplated.
In another embodiment, a stainless steel braid, cable, or strand of wires twisted together provides the inner core member to limit compressibility of the coil (bifilar wire)
stainless steel, tip 160.
In this embodiment, the core 120 is composed of a shape memory material, preferably Nitinol (a nickel titanium alloy), which has a memorized configuration of a sinuous or s-shape substantially corresponding to the s-shape of the bifilar wire 130. In the softer martensitic state within the sheath, core 120 is in a substantially linear configuration. This state is used for delivering the wire to the surgical site. When the wire is exposed to warmer body temperature, the core 120 transforms to its austenitic state, assuming the s-shaped memorized configuration. Cold saline is delivered through the catheter during delivery to maintain the core 120 in this martensitic state; the warming occurs by exposure to body temperature to transform the core 120 to the memorized state. Such memorized s-shape helps maintain the s-shape of the bifilar wire 130 during use. Cold saline can also be delivered to the core 120 at the end of the procedure to facilitate withdrawal.
The Nitinol core 120, like the Nylon core 20, is not compressible so it will also limit the compressibility of the bifilar wire 130. The Nitinol core 120 also will increase the stiffness of the wire 100, thereby reducing the chance of knotting and kinking and increase the strength of the wire to accommodate any spasms in the vessel. Its shape memory helps hold the amplitude of the bifilar wire 130 during use to maintain its force against the clot for maceration upon rotation. It preferably extends about 4-5 inches so it extends through the distal linear portion and sinuous portion of the wire 130, terminating at end 122. Alternately it can extend a shorter or longer length within the wire 130, or even the entire length as shown in the schematic view of Figure 5. It preferably has an outer diameter of about .008 inches to about .013 inches, and more preferably about .012 inches, corresponding to the inner diameter of the coil. Other dimensions are also contemplated.
In another embodiment, a stainless steel braid, cable, or strand of wires twisted together provides the inner core member to limit compressibility of the coil (bifilar wire)
8 and provide increased stiffness, strength and other advantages of the core enumerated above. This is shown in the embodiment of Figures 7 and 8 where wire 200 has inner core 220 of seven twisted stainless steel wires. A different number of twisted wires is also contemplated. The other elements of the wire 200, e.g., outer bifilar wire 230, metal tip 260, tip 280 shrink wrap 250, etc., are the same as in wires 10 and 100 described herein.
The rotational thrombectomy wires 10, 100 and 200 of the present invention can be used with various thrombectomy catheters to macerate thrombus within the vessel.
The rotational thrombectomy wire 10 (or wire 100 or 200) is contained within a flexible sheath or sleeve C of a catheter as shown in Figure 1. Relative movement of the wire and sheath C will enable the wire 10 to be exposed to assume the curved (sinuous) configuration described below to enable removal of obstructions, such as blood clots, from the lumen of the vessel.
A motor powered by a battery is contained within a housing to macerate and liquefy the thrombus into small particles within the vessel lumen. This is shown schematically in Figure 2. Wire 10 (or 100 or 200) is operatively connected to the motor.
Operative connection encompasses direct connection or connection via interposing components to enable rotation when the motor is actuated. The curved regions of the wire or (100 or 200) are compressed so the wire (including the distal region 16, 116 or 216, respectively) is in a substantially straight or linear non-deployed configuration when in the sheath C. This covering of the wire 10 (or 100 or 200) by sheath C
facilitates insertion through an introducer sheath and manipulation within the vessel.
When the flexible sheath C is retracted, the wire is exposed to enable the wire to return to its non-linear substantially sinuous configuration for rotation about its longitudinal axis within the lumen of the vessel.
Fluids, such as imaging dye can be injected through the port D into the lumen of the sheath C in the space between wire 10 (or 100 or 200) and the inner wall of the sheath C, and exiting the distal opening to flow into the vessel. This imaging dye provides an indication that fluid flow has resumed in the vessel. The lumen of the sheath can also receive cold saline to cool the Nitinol core 120 as described above.
The rotational thrombectomy wires 10, 100 and 200 of the present invention can be used with various thrombectomy catheters to macerate thrombus within the vessel.
The rotational thrombectomy wire 10 (or wire 100 or 200) is contained within a flexible sheath or sleeve C of a catheter as shown in Figure 1. Relative movement of the wire and sheath C will enable the wire 10 to be exposed to assume the curved (sinuous) configuration described below to enable removal of obstructions, such as blood clots, from the lumen of the vessel.
A motor powered by a battery is contained within a housing to macerate and liquefy the thrombus into small particles within the vessel lumen. This is shown schematically in Figure 2. Wire 10 (or 100 or 200) is operatively connected to the motor.
Operative connection encompasses direct connection or connection via interposing components to enable rotation when the motor is actuated. The curved regions of the wire or (100 or 200) are compressed so the wire (including the distal region 16, 116 or 216, respectively) is in a substantially straight or linear non-deployed configuration when in the sheath C. This covering of the wire 10 (or 100 or 200) by sheath C
facilitates insertion through an introducer sheath and manipulation within the vessel.
When the flexible sheath C is retracted, the wire is exposed to enable the wire to return to its non-linear substantially sinuous configuration for rotation about its longitudinal axis within the lumen of the vessel.
Fluids, such as imaging dye can be injected through the port D into the lumen of the sheath C in the space between wire 10 (or 100 or 200) and the inner wall of the sheath C, and exiting the distal opening to flow into the vessel. This imaging dye provides an indication that fluid flow has resumed in the vessel. The lumen of the sheath can also receive cold saline to cool the Nitinol core 120 as described above.
9 The rotational thrombectomy wires 10, 100 and 200 of the present invention can also be used with the thrombectomy catheters having one or more balloons such as the balloon described in the '812 publication. The wires 10, 100 and 200 can further be used with other thrombectomy catheters.
While the above description contains many specifics, those specifics should not be construed as limitations on the scope of the disclosure, but merely as exemplifications of preferred embodiments thereof. Those skilled in the art will envision many other possible variations that are within the scope and spirit of the disclosure as defined by the claims appended hereto.
While the above description contains many specifics, those specifics should not be construed as limitations on the scope of the disclosure, but merely as exemplifications of preferred embodiments thereof. Those skilled in the art will envision many other possible variations that are within the scope and spirit of the disclosure as defined by the claims appended hereto.
Claims (20)
1. A rotatable thrombectomy wire for breaking up thrombus or other obstructive material, the wire comprising:
an inner core composed of a flexible material; and a multifilar outer wire surrounding at least a portion of the inner core, the multifilar outer wire including at least first and second metal wires wound side by side and having a sinuous shaped portion at a distal region, the inner core having a sinuous shaped portion within the sinuous shaped portion of the multifilar outer wire, the inner core limiting the compressibility of the multifilar wire, the multifilar wire operatively connectable at a proximal end to a motor for rotating the wire to macerate thrombus.
an inner core composed of a flexible material; and a multifilar outer wire surrounding at least a portion of the inner core, the multifilar outer wire including at least first and second metal wires wound side by side and having a sinuous shaped portion at a distal region, the inner core having a sinuous shaped portion within the sinuous shaped portion of the multifilar outer wire, the inner core limiting the compressibility of the multifilar wire, the multifilar wire operatively connectable at a proximal end to a motor for rotating the wire to macerate thrombus.
2. The thrombectomy wire of claim 1, wherein the inner core is composed of nylon material.
3. The thrombectomy wire of claim 1, wherein the inner core is composed of shape memory material, the inner core having a memorized configuration, the inner core assuming its sinuous shape in the memorized configuration.
4. The thrombectomy wire of claim 1, wherein the inner core is composed of at least two twisted wires of stainless steel.
5. The thrombectomy wire of claim 1, further comprising a polymeric material surrounding at least a distal portion of the multifilar wire.
6. The thrombectomy wire of claim 5, wherein the polymeric material is a coating over the multifilar wire.
7. The thrombectomy wire of claim 5, wherein the polymeric material comprises a shrink wrap material attached to the multifilar wire.
8. The thrombectomy wire of claim 5, wherein the inner core is composed of nylon material.
9. The thrombectomy wire of claim 5, wherein the inner core is composed of at least two twisted wires of stainless steel.
10. The thrombectomy wire of claim 1, wherein the first and second metal wires are wound together such that the coils of the first wire occupy the space between adjacent turns of the second wire.
11. The thrombectomy wire of claim 5, wherein the first and second wires are wound together such that the coils of the first wire occupy the space between adjacent turns of the second wire, and further including a flexible and blunt tip positioned at a distal end of the wire.
12. The thrombectomy apparatus of claim 1, wherein the outer wire forms coils with essentially no spaces between adjacent coils and the coils of the outer wire have an inner diameter approximately equal to an outer diameter of the inner core.
13. A rotatable thrombectomy wire for breaking up thrombus or other obstructive material in a lumen of a vessel, the wire comprising;
a multifilar outer wire including at least first and second metal wires wound side by side and operatively connectable at a proximal end to a motor for rotating the wire to macerate thrombus, the multifilar wire having a sinuous shaped portion at a distal region;
and a polymeric material surrounding at least a distal region of the sinuous of the first and second wires to block the interstices of the multifilar wire.
a multifilar outer wire including at least first and second metal wires wound side by side and operatively connectable at a proximal end to a motor for rotating the wire to macerate thrombus, the multifilar wire having a sinuous shaped portion at a distal region;
and a polymeric material surrounding at least a distal region of the sinuous of the first and second wires to block the interstices of the multifilar wire.
14. The thrombectomy wire of claim 14, wherein the polymeric material comprises a shrink wrap material attached to the multifilar wire.
15. A thrombectomy apparatus for breaking up thrombus or other obstructive material comprising a handle, a sheath, a battery, a motor powered by the battery, and a sinuous thrombectomy wire having at least one wire wound to form a coil and an inner core composed of a material to limit the compressibility of the coil, the coil having a sinuous portion and surrounding at least a distal region of the inner core, the inner core having a sinuous portion within the sinuous portion of the coil, the sinuous portion of the inner core and the coil movable from a straighter configuration within the sheath for delivery to a sinuous configuration when exposed from the sheath.
16. The thrombectomy apparatus of claim 15, further comprising a polymeric material surrounding at least a distal portion of the coil to cover the interstices of the coil.
17. The thrombectomy apparatus of claim 16, wherein the core is composed of nylon material.
18. The thrombectomy apparatus of claim 16, wherein the core is composed of at least two twisted wires of stainless steel.
19. A method for breaking up thrombus or other obstructive material in a native vessel comprising:
providing a thrombectomy wire having an inner core composed of a flexible material, at least one outer wire surrounding at least a portion of the inner core wherein the outer wire has a sinuous shaped portion at a distal region and the inner core has a sinuous portion within the sinuous portion of the outer wire, and a polymeric material surrounding at least a distal portion of the at least one outer wire to block the interstices of the at least one outer wire;
delivering the wire to the lumen of the native vessel such that the sinuous shaped portions of the inner core and outer wire are in a more linear configuration within a sheath;
exposing the sinuous portion of the inner core and the at least one outer wire; and actuating a motor operatively connected to the thrombectomy wire so the sinuous portion of the at least one outer wire contacts the inner wall of the native vessel to macerate thrombus in the vessel.
providing a thrombectomy wire having an inner core composed of a flexible material, at least one outer wire surrounding at least a portion of the inner core wherein the outer wire has a sinuous shaped portion at a distal region and the inner core has a sinuous portion within the sinuous portion of the outer wire, and a polymeric material surrounding at least a distal portion of the at least one outer wire to block the interstices of the at least one outer wire;
delivering the wire to the lumen of the native vessel such that the sinuous shaped portions of the inner core and outer wire are in a more linear configuration within a sheath;
exposing the sinuous portion of the inner core and the at least one outer wire; and actuating a motor operatively connected to the thrombectomy wire so the sinuous portion of the at least one outer wire contacts the inner wall of the native vessel to macerate thrombus in the vessel.
20. The method of claim 19, further comprising the step of retracting the thrombectomy wire during rotation.
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US62862304P | 2004-11-17 | 2004-11-17 | |
US60/628,623 | 2004-11-17 | ||
US11/017,112 US7819887B2 (en) | 2004-11-17 | 2004-12-20 | Rotational thrombectomy wire |
US11/017,112 | 2004-12-20 | ||
PCT/US2005/039856 WO2006055265A1 (en) | 2004-11-17 | 2005-11-02 | Rotational thrombectomy wire |
Publications (1)
Publication Number | Publication Date |
---|---|
CA2588152A1 true CA2588152A1 (en) | 2006-05-26 |
Family
ID=35735369
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002588152A Abandoned CA2588152A1 (en) | 2004-11-17 | 2005-11-02 | Rotational thrombectomy wire |
Country Status (7)
Country | Link |
---|---|
US (5) | US7819887B2 (en) |
EP (1) | EP1811908B1 (en) |
JP (2) | JP2008520351A (en) |
AU (1) | AU2005306899B2 (en) |
CA (1) | CA2588152A1 (en) |
ES (1) | ES2455515T3 (en) |
WO (1) | WO2006055265A1 (en) |
Families Citing this family (57)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2001028618A2 (en) | 1999-10-22 | 2001-04-26 | Boston Scientific Corporation | Double balloon thrombectomy catheter |
US8414543B2 (en) | 1999-10-22 | 2013-04-09 | Rex Medical, L.P. | Rotational thrombectomy wire with blocking device |
US7819887B2 (en) | 2004-11-17 | 2010-10-26 | Rex Medical, L.P. | Rotational thrombectomy wire |
CN101547653B (en) | 2006-09-13 | 2012-02-29 | 瓦斯库勒英赛特有限公司 | Vascular treatment device |
WO2008097993A2 (en) | 2007-02-05 | 2008-08-14 | Boston Scientific Limited | Thrombectomy apparatus and method |
EP2121100A2 (en) | 2007-02-08 | 2009-11-25 | C.R.Bard, Inc. | Shape memory medical device and methods of manufacturing |
JP5114179B2 (en) * | 2007-12-17 | 2013-01-09 | Hoya株式会社 | Bipolar high-frequency treatment instrument for endoscope |
US9101387B2 (en) * | 2008-06-05 | 2015-08-11 | Cardiovascular Systems, Inc. | Directional rotational atherectomy device with offset spinning abrasive element |
US8939991B2 (en) | 2008-06-08 | 2015-01-27 | Hotspur Technologies, Inc. | Apparatus and methods for removing obstructive material from body lumens |
AU2009266808B2 (en) | 2008-07-03 | 2014-07-10 | Teleflex Life Sciences Limited | Apparatus and methods for treating obstructions within body lumens |
US8945160B2 (en) | 2008-07-03 | 2015-02-03 | Hotspur Technologies, Inc. | Apparatus and methods for treating obstructions within body lumens |
US9101382B2 (en) | 2009-02-18 | 2015-08-11 | Hotspur Technologies, Inc. | Apparatus and methods for treating obstructions within body lumens |
WO2015019321A1 (en) * | 2013-08-08 | 2015-02-12 | Rapid Medical Ltd. | Clot removal device with steerable element |
US9034008B2 (en) | 2008-08-29 | 2015-05-19 | Rapid Medical Ltd. | Device and method involving stabilization during clot removal |
CA2737653C (en) | 2008-09-22 | 2018-02-27 | Hotspur Technologies, Inc. | Flow restoration systems and methods for use |
GB0902339D0 (en) * | 2009-02-12 | 2009-04-01 | St Georges Healthcare Nhs Trus | Percutaneous guidewire |
US20120109057A1 (en) | 2009-02-18 | 2012-05-03 | Hotspur Technologies, Inc. | Apparatus and methods for treating obstructions within body lumens |
CN102427844B (en) * | 2009-03-30 | 2014-09-03 | C·R·巴德股份有限公司 | Tip-shapeable guidewire |
CA2797222C (en) * | 2009-04-23 | 2017-07-25 | Rafael Medina | Instrument for creating a controlled capsulorhexis for cataract surgery |
US8663259B2 (en) | 2010-05-13 | 2014-03-04 | Rex Medical L.P. | Rotational thrombectomy wire |
US9795406B2 (en) | 2010-05-13 | 2017-10-24 | Rex Medical, L.P. | Rotational thrombectomy wire |
US9023070B2 (en) | 2010-05-13 | 2015-05-05 | Rex Medical, L.P. | Rotational thrombectomy wire coupler |
US8764779B2 (en) | 2010-05-13 | 2014-07-01 | Rex Medical, L.P. | Rotational thrombectomy wire |
US9107691B2 (en) * | 2010-10-19 | 2015-08-18 | Distal Access, Llc | Apparatus for rotating medical devices, systems including the apparatus, and associated methods |
US8845621B2 (en) | 2010-10-19 | 2014-09-30 | Distal Access, Llc | Apparatus for rotating medical devices, systems including the apparatus, and associated methods |
US9585667B2 (en) * | 2010-11-15 | 2017-03-07 | Vascular Insights Llc | Sclerotherapy catheter with lumen having wire rotated by motor and simultaneous withdrawal from vein |
EP2700368B1 (en) | 2011-04-27 | 2015-02-11 | Rex Medical, L.P. | Rotational thrombectomy wire |
CA2776090A1 (en) | 2011-05-16 | 2012-11-16 | Rex Medical, L.P. | Rotational thrombectomy wire coupler |
US8852220B2 (en) | 2011-09-07 | 2014-10-07 | Abbott Cardiovascular Systems, Inc. | Thrombus penetrating devices, systems, and methods |
US9126013B2 (en) | 2012-04-27 | 2015-09-08 | Teleflex Medical Incorporated | Catheter with adjustable guidewire exit position |
US9757536B2 (en) * | 2012-07-17 | 2017-09-12 | Novartis Ag | Soft tip cannula |
WO2014074955A1 (en) | 2012-11-08 | 2014-05-15 | Distal Access, Llc | Apparatus for rotating medical devices, systems including the apparatus, and associated methods |
US20140330286A1 (en) | 2013-04-25 | 2014-11-06 | Michael P. Wallace | Methods and Devices for Removing Obstructing Material From the Human Body |
US10219814B2 (en) | 2013-12-13 | 2019-03-05 | Rex Medical, L.P. | Aspiration system for thrombectomy procedures |
US9782191B2 (en) | 2014-01-21 | 2017-10-10 | Cook Medical Technologies Llc | Cutting devices and methods |
US10271869B2 (en) | 2014-03-01 | 2019-04-30 | Rex Medical, L.P. | Atherectomy device |
US10667836B2 (en) | 2014-04-28 | 2020-06-02 | Boston Scientific Scimed, Inc. | Tissue resectors, hand operated tissue resecting systems, and associated methods |
US10433868B2 (en) | 2014-12-27 | 2019-10-08 | Rex Medical, L.P. | Artherectomy device |
US10463389B2 (en) | 2014-12-27 | 2019-11-05 | Rex Medical, L.P. | Atherectomy device |
US10561440B2 (en) | 2015-09-03 | 2020-02-18 | Vesatek, Llc | Systems and methods for manipulating medical devices |
US11253292B2 (en) | 2015-09-13 | 2022-02-22 | Rex Medical, L.P. | Atherectomy device |
CN105232095B (en) * | 2015-09-28 | 2017-11-21 | 宁波胜杰康生物科技有限公司 | A kind of operating theater instruments of multistage adjustable bending |
US10226263B2 (en) | 2015-12-23 | 2019-03-12 | Incuvate, Llc | Aspiration monitoring system and method |
US10307175B2 (en) | 2016-03-26 | 2019-06-04 | Rex Medical, L.P | Atherectomy device |
US10980555B2 (en) | 2016-07-12 | 2021-04-20 | Cardioprolific Inc. | Methods and devices for clots and tissue removal |
CA3044538A1 (en) * | 2016-11-30 | 2018-06-07 | The Regents Of The University Of California | Microneedle fabrication and device implantation |
US11224458B2 (en) | 2017-04-10 | 2022-01-18 | The Regents Of The University Of Michigan | Hydrodynamic vortex aspiration catheter |
AU2018250821B2 (en) | 2017-04-10 | 2024-03-14 | The Regents Of The University Of Michigan | Hydrodynamic vortex aspiration catheter |
WO2018204697A1 (en) | 2017-05-03 | 2018-11-08 | Medtronic Vascular, Inc. | Tissue-removing catheter |
US11690645B2 (en) | 2017-05-03 | 2023-07-04 | Medtronic Vascular, Inc. | Tissue-removing catheter |
CN107335126A (en) * | 2017-07-28 | 2017-11-10 | 苏州斯恩维医疗科技有限公司 | One kind intervention conveying composite rope and preparation method thereof |
US11678905B2 (en) | 2018-07-19 | 2023-06-20 | Walk Vascular, Llc | Systems and methods for removal of blood and thrombotic material |
US11357534B2 (en) | 2018-11-16 | 2022-06-14 | Medtronic Vascular, Inc. | Catheter |
US11819236B2 (en) | 2019-05-17 | 2023-11-21 | Medtronic Vascular, Inc. | Tissue-removing catheter |
US11696793B2 (en) | 2021-03-19 | 2023-07-11 | Crossfire Medical Inc | Vascular ablation |
US20220330958A1 (en) | 2021-04-19 | 2022-10-20 | Argon Medical Devices, Inc. | Disposable thrombectomy maceration and aspiration system |
US11911581B1 (en) | 2022-11-04 | 2024-02-27 | Controlled Delivery Systems, Inc. | Catheters and related methods for the aspiration controlled delivery of closure agents |
Family Cites Families (137)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE1075903B (en) | 1958-02-04 | 1960-02-18 | Siemens Ag | Safety coupling with permanent magnets |
US3612058A (en) * | 1968-04-17 | 1971-10-12 | Electro Catheter Corp | Catheter stylets |
US3749085A (en) * | 1970-06-26 | 1973-07-31 | J Willson | Vascular tissue removing device |
JPS5620839U (en) | 1979-07-25 | 1981-02-24 | ||
DE3327779A1 (en) * | 1983-08-02 | 1985-02-14 | B. Braun Melsungen Ag, 3508 Melsungen | MANDRIN FOR TUBULAR CATHETERS AND BODY SEEDS |
US5067957A (en) * | 1983-10-14 | 1991-11-26 | Raychem Corporation | Method of inserting medical devices incorporating SIM alloy elements |
US4745919A (en) * | 1985-02-01 | 1988-05-24 | Bundy Mark A | Transluminal lysing system |
CA1293663C (en) | 1986-01-06 | 1991-12-31 | David Christopher Auth | Transluminal microdissection device |
US5025799A (en) * | 1987-05-13 | 1991-06-25 | Wilson Bruce C | Steerable memory alloy guide wires |
US5211183A (en) * | 1987-05-13 | 1993-05-18 | Wilson Bruce C | Steerable memory alloy guide wires |
US4883460A (en) | 1988-04-25 | 1989-11-28 | Zanetti Paul H | Technique for removing deposits from body vessels |
US5067489A (en) * | 1988-08-16 | 1991-11-26 | Flexmedics Corporation | Flexible guide with safety tip |
US4906244A (en) | 1988-10-04 | 1990-03-06 | Cordis Corporation | Balloons for medical devices and fabrication thereof |
US4984581A (en) * | 1988-10-12 | 1991-01-15 | Flexmedics Corporation | Flexible guide having two-way shape memory alloy |
US5203772A (en) * | 1989-01-09 | 1993-04-20 | Pilot Cardiovascular Systems, Inc. | Steerable medical device |
DE3931350A1 (en) * | 1989-09-20 | 1991-03-28 | Kaltenbach Martin | GUIDE SLEEVE FOR IMPORTING CATHETERS |
US5624392A (en) | 1990-05-11 | 1997-04-29 | Saab; Mark A. | Heat transfer catheters and methods of making and using same |
US5345945A (en) * | 1990-08-29 | 1994-09-13 | Baxter International Inc. | Dual coil guidewire with radiopaque distal tip |
US5341818A (en) * | 1992-12-22 | 1994-08-30 | Advanced Cardiovascular Systems, Inc. | Guidewire with superelastic distal portion |
US5984877A (en) * | 1991-02-05 | 1999-11-16 | Fleischhacker, Jr.; Joseph F. | Guide wire marker technique and coil spring marker technique |
CA2068584C (en) * | 1991-06-18 | 1997-04-22 | Paul H. Burmeister | Intravascular guide wire and method for manufacture thereof |
US5213111A (en) * | 1991-07-10 | 1993-05-25 | Cook Incorporated | Composite wire guide construction |
US5251085A (en) * | 1991-07-17 | 1993-10-05 | Maxtor Corporation | Pivotable arm assembly with reduced thermal distortion |
US5261877A (en) * | 1991-07-22 | 1993-11-16 | Dow Corning Wright | Method of performing a thrombectomy procedure |
US5605162A (en) * | 1991-10-15 | 1997-02-25 | Advanced Cardiovascular Systems, Inc. | Method for using a variable stiffness guidewire |
US5333620A (en) * | 1991-10-30 | 1994-08-02 | C. R. Bard, Inc. | High performance plastic coated medical guidewire |
US5253653A (en) * | 1991-10-31 | 1993-10-19 | Boston Scientific Corp. | Fluoroscopically viewable guidewire for catheters |
FR2685190B1 (en) | 1991-12-23 | 1998-08-07 | Jean Marie Lefebvre | ROTARY ATHERECTOMY OR THROMBECTOMY DEVICE WITH CENTRIFUGAL TRANSVERSE DEVELOPMENT. |
US5251640A (en) * | 1992-03-31 | 1993-10-12 | Cook, Incorporated | Composite wire guide shaft |
US5217026A (en) * | 1992-04-06 | 1993-06-08 | Kingston Technologies, Inc. | Guidewires with lubricious surface and method of their production |
WO1993019679A1 (en) * | 1992-04-07 | 1993-10-14 | The Johns Hopkins University | A percutaneous mechanical fragmentation catheter system |
US5313967A (en) * | 1992-07-24 | 1994-05-24 | Medtronic, Inc. | Helical guidewire |
EP0597195B1 (en) * | 1992-08-18 | 1999-07-21 | The Spectranetics Corporation | Fiber optic guide wire |
US5299580A (en) * | 1992-10-09 | 1994-04-05 | Scimed Life Systems, Inc. | Guidewire with safety ribbon with substantially axially symmetric flexibility |
US5312427A (en) * | 1992-10-16 | 1994-05-17 | Shturman Cardiology Systems, Inc. | Device and method for directional rotational atherectomy |
US5360432A (en) * | 1992-10-16 | 1994-11-01 | Shturman Cardiology Systems, Inc. | Abrasive drive shaft device for directional rotational atherectomy |
US5501694A (en) | 1992-11-13 | 1996-03-26 | Scimed Life Systems, Inc. | Expandable intravascular occlusion material removal devices and methods of use |
US5490859A (en) * | 1992-11-13 | 1996-02-13 | Scimed Life Systems, Inc. | Expandable intravascular occlusion material removal devices and methods of use |
US5540707A (en) | 1992-11-13 | 1996-07-30 | Scimed Life Systems, Inc. | Expandable intravascular occlusion material removal devices and methods of use |
US5372144A (en) | 1992-12-01 | 1994-12-13 | Scimed Life Systems, Inc. | Navigability improved guidewire construction and method of using same |
WO1995001123A2 (en) * | 1993-06-24 | 1995-01-12 | Conceptus, Inc. | Guidewire-type device and use thereof |
US6673025B1 (en) * | 1993-12-01 | 2004-01-06 | Advanced Cardiovascular Systems, Inc. | Polymer coated guidewire |
CH689170A5 (en) * | 1994-07-11 | 1998-11-13 | Weissenfluh Hawe Neos | Flexible post or not deformable radially and longitudinally avvolgimatrici device for dental use. |
US5938623A (en) * | 1994-10-28 | 1999-08-17 | Intella Interventional Systems | Guide wire with adjustable stiffness |
US5584843A (en) * | 1994-12-20 | 1996-12-17 | Boston Scientific Corporation | Shaped wire multi-burr rotational ablation device |
US5653722A (en) * | 1995-01-03 | 1997-08-05 | Kieturakis; Maciej J. | Anterograde/retrograde spiral dissector and method of use in vein grafting |
US5797856A (en) * | 1995-01-05 | 1998-08-25 | Cardiometrics, Inc. | Intravascular guide wire and method |
US5680873A (en) * | 1995-03-02 | 1997-10-28 | Scimed Life Systems, Inc. | Braidless guide catheter |
US5746701A (en) * | 1995-09-14 | 1998-05-05 | Medtronic, Inc. | Guidewire with non-tapered tip |
US5569179A (en) | 1995-10-26 | 1996-10-29 | Medelex, Inc. | Acoustic catheter with magnetic drive |
US6019736A (en) * | 1995-11-06 | 2000-02-01 | Francisco J. Avellanet | Guidewire for catheter |
US6004279A (en) | 1996-01-16 | 1999-12-21 | Boston Scientific Corporation | Medical guidewire |
US5836893A (en) * | 1996-03-08 | 1998-11-17 | Scimed Life Systems, Inc. | Intravascular guidewire |
US5788710A (en) | 1996-04-30 | 1998-08-04 | Boston Scientific Corporation | Calculus removal |
US5840046A (en) * | 1996-06-21 | 1998-11-24 | Medtronic, Inc. | Guidewire having hydrophilic coating |
US5833631A (en) * | 1996-06-28 | 1998-11-10 | Target Therapeutics, Inc. | Fiber tip guidewire |
US5910364A (en) * | 1996-07-10 | 1999-06-08 | Asahi Intecc Co., Ltd. | Guide wire and a method of making the same |
US5762637A (en) * | 1996-08-27 | 1998-06-09 | Scimed Life Systems, Inc. | Insert molded catheter tip |
US6217595B1 (en) * | 1996-11-18 | 2001-04-17 | Shturman Cardiology Systems, Inc. | Rotational atherectomy device |
US5916166A (en) * | 1996-11-19 | 1999-06-29 | Interventional Technologies, Inc. | Medical guidewire with fully hardened core |
US5882329A (en) * | 1997-02-12 | 1999-03-16 | Prolifix Medical, Inc. | Apparatus and method for removing stenotic material from stents |
US6251086B1 (en) * | 1999-07-27 | 2001-06-26 | Scimed Life Systems, Inc. | Guide wire with hydrophilically coated tip |
US5843103A (en) * | 1997-03-06 | 1998-12-01 | Scimed Life Systems, Inc. | Shaped wire rotational atherectomy device |
US5924998A (en) * | 1997-03-06 | 1999-07-20 | Scimed Life System, Inc. | Guide wire with hydrophilically coated tip |
US5885227A (en) * | 1997-03-25 | 1999-03-23 | Radius Medical Technologies, Inc. | Flexible guidewire with radiopaque plastic tip |
CA2204779A1 (en) * | 1997-05-07 | 1998-11-07 | Mark Sunderland | Universal catheter driver/handle |
JPH1119217A (en) | 1997-07-04 | 1999-01-26 | Olympus Optical Co Ltd | Medical guide wire |
US6090118A (en) * | 1998-07-23 | 2000-07-18 | Mcguckin, Jr.; James F. | Rotational thrombectomy apparatus and method with standing wave |
WO2001028618A2 (en) * | 1999-10-22 | 2001-04-26 | Boston Scientific Corporation | Double balloon thrombectomy catheter |
US7037316B2 (en) * | 1997-07-24 | 2006-05-02 | Mcguckin Jr James F | Rotational thrombectomy device |
US6494890B1 (en) | 1997-08-14 | 2002-12-17 | Shturman Cardiology Systems, Inc. | Eccentric rotational atherectomy device |
US6080117A (en) * | 1997-10-16 | 2000-06-27 | Scimed Life Systems, Inc. | Guide wire extension system |
US6371928B1 (en) * | 1997-11-07 | 2002-04-16 | Prolifix Medical, Inc. | Guidewire for positioning a catheter against a lumen wall |
EP1030610A1 (en) | 1997-11-07 | 2000-08-30 | Prolifix Medical, Inc. | Methods and systems for treating obstructions in a body lumen |
US6106485A (en) * | 1997-11-18 | 2000-08-22 | Advanced Cardivascular Systems, Inc. | Guidewire with shaped intermediate portion |
US6168570B1 (en) * | 1997-12-05 | 2001-01-02 | Micrus Corporation | Micro-strand cable with enhanced radiopacity |
US9254143B2 (en) | 1998-02-25 | 2016-02-09 | Revascular Therapeutics, Inc. | Guidewire for crossing occlusions or stenoses having a shapeable distal end |
US6001112A (en) * | 1998-04-10 | 1999-12-14 | Endicor Medical, Inc. | Rotational atherectomy device |
US6113614A (en) * | 1998-05-05 | 2000-09-05 | Ensurg, Inc. | Medical device for dissolution of tissue within the human body |
US6306105B1 (en) | 1998-05-14 | 2001-10-23 | Scimed Life Systems, Inc. | High performance coil wire |
US6083198A (en) | 1998-06-25 | 2000-07-04 | Cardiovention, Inc. | Perfusion catheter providing segmented flow regions and methods of use |
DE69914609T2 (en) * | 1998-08-19 | 2005-01-05 | Cook Inc., Bloomington | Preformed guidewire |
CA2352314C (en) | 1998-12-01 | 2008-04-01 | Advanced Cardiovascular Systems, Inc. | Guidewire having linear change in stiffness |
US6165140A (en) * | 1998-12-28 | 2000-12-26 | Micrus Corporation | Composite guidewire |
US6402706B2 (en) | 1998-12-30 | 2002-06-11 | Advanced Cardiovascular Systems, Inc. | Guide wire with multiple polymer jackets over distal and intermediate core sections |
US6482215B1 (en) * | 1999-02-02 | 2002-11-19 | Samuel Shiber | Adjustable vessel cleaner and method |
US6758851B2 (en) * | 1999-02-02 | 2004-07-06 | Samuel Shiber | Vessel cleaner |
US6767353B1 (en) * | 2002-03-01 | 2004-07-27 | Samuel Shiber | Thrombectomy catheter |
US6475226B1 (en) * | 1999-02-03 | 2002-11-05 | Scimed Life Systems, Inc. | Percutaneous bypass apparatus and method |
WO2000065987A1 (en) * | 1999-04-30 | 2000-11-09 | Applied Medical Resources Corporation | Guidewire |
US6790215B2 (en) * | 1999-04-30 | 2004-09-14 | Edwards Lifesciences Corporation | Method of use for percutaneous material removal device and tip |
US6620179B2 (en) * | 1999-08-10 | 2003-09-16 | Neurovasx, Inc. | Clot disrupting wire/catheter assembly |
US6702830B1 (en) * | 1999-09-17 | 2004-03-09 | Bacchus Vascular, Inc. | Mechanical pump for removal of fragmented matter and methods of manufacture and use |
US6454775B1 (en) * | 1999-12-06 | 2002-09-24 | Bacchus Vascular Inc. | Systems and methods for clot disruption and retrieval |
US8414543B2 (en) | 1999-10-22 | 2013-04-09 | Rex Medical, L.P. | Rotational thrombectomy wire with blocking device |
US6217589B1 (en) * | 1999-10-27 | 2001-04-17 | Scimed Life Systems, Inc. | Retrieval device made of precursor alloy cable and method of manufacturing |
US6458127B1 (en) * | 1999-11-22 | 2002-10-01 | Csaba Truckai | Polymer embolic elements with metallic coatings for occlusion of vascular malformations |
US6579246B2 (en) * | 1999-12-22 | 2003-06-17 | Sarcos, Lc | Coronary guidewire system |
US6929633B2 (en) * | 2000-01-25 | 2005-08-16 | Bacchus Vascular, Inc. | Apparatus and methods for clot dissolution |
US6663613B1 (en) | 2000-01-25 | 2003-12-16 | Bacchus Vascular, Inc. | System and methods for clot dissolution |
ITVE20000017U1 (en) * | 2000-01-31 | 2002-01-31 | Rex Medical Lp | ATERECTOMY DEVICE. |
US6579299B2 (en) * | 2000-01-31 | 2003-06-17 | Rex Medical, L.P. | Atherectomy device |
US20010031981A1 (en) * | 2000-03-31 | 2001-10-18 | Evans Michael A. | Method and device for locating guidewire and treating chronic total occlusions |
US6599254B2 (en) * | 2000-05-08 | 2003-07-29 | R. Edward Winters | Multi-feature steerable guidewire for vascular systems |
US6602262B2 (en) | 2000-06-02 | 2003-08-05 | Scimed Life Systems, Inc. | Medical device having linear to rotation control |
US6824545B2 (en) | 2000-06-29 | 2004-11-30 | Concentric Medical, Inc. | Systems, methods and devices for removing obstructions from a blood vessel |
US6602207B1 (en) * | 2000-07-19 | 2003-08-05 | Scimed Life Systems, Inc. | Guide wire stiffness transition element |
DE60017744T2 (en) * | 2000-10-03 | 2006-01-12 | William Cook Europe Aps | guidewire |
US6620114B2 (en) * | 2000-10-05 | 2003-09-16 | Scimed Life Systems, Inc. | Guidewire having a marker segment for length assessment |
US6669652B2 (en) | 2000-12-21 | 2003-12-30 | Advanced Cardiovascular Systems, Inc. | Guidewire with tapered distal coil |
US6881194B2 (en) * | 2001-03-21 | 2005-04-19 | Asahi Intec Co., Ltd. | Wire-stranded medical hollow tube, and a medical guide wire |
WO2002083009A1 (en) * | 2001-04-12 | 2002-10-24 | Olympus Optical Co., Ltd. | Treatment tool for endoscope |
CA2449433A1 (en) * | 2001-06-20 | 2003-01-03 | Microvention, Inc. | Medical devices having full or partial polymer coatings and their methods of manufacture |
US6911016B2 (en) * | 2001-08-06 | 2005-06-28 | Scimed Life Systems, Inc. | Guidewire extension system |
US6918882B2 (en) * | 2001-10-05 | 2005-07-19 | Scimed Life Systems, Inc. | Guidewire with stiffness blending connection |
JP4028245B2 (en) * | 2002-01-28 | 2007-12-26 | テルモ株式会社 | Guide wire |
US6926725B2 (en) * | 2002-04-04 | 2005-08-09 | Rex Medical, L.P. | Thrombectomy device with multi-layered rotational wire |
US8257278B2 (en) | 2002-05-14 | 2012-09-04 | Advanced Cardiovascular Systems, Inc. | Metal composite guide wire |
JP4138583B2 (en) * | 2002-08-08 | 2008-08-27 | テルモ株式会社 | Guide wire |
US7309318B2 (en) | 2002-09-18 | 2007-12-18 | Boston Scientific Scimed, Inc. | Flexible composite guidewire for intravascular catheter |
US7625337B2 (en) | 2003-01-17 | 2009-12-01 | Gore Enterprise Holdings, Inc. | Catheter assembly |
US7182735B2 (en) * | 2003-02-26 | 2007-02-27 | Scimed Life Systems, Inc. | Elongated intracorporal medical device |
US7169118B2 (en) * | 2003-02-26 | 2007-01-30 | Scimed Life Systems, Inc. | Elongate medical device with distal cap |
US20040193073A1 (en) * | 2003-03-31 | 2004-09-30 | Demello Richard M. | Composite guidewire with a linear elastic distal portion |
US7862575B2 (en) * | 2003-05-21 | 2011-01-04 | Yale University | Vascular ablation apparatus and method |
US7540845B2 (en) * | 2003-09-05 | 2009-06-02 | Boston Scientific Scimed, Inc | Medical device coil |
US7824345B2 (en) * | 2003-12-22 | 2010-11-02 | Boston Scientific Scimed, Inc. | Medical device with push force limiter |
US7666202B2 (en) | 2004-01-07 | 2010-02-23 | Cardiovascular Systems, Inc. | Orbital atherectomy device guide wire design |
US7819887B2 (en) * | 2004-11-17 | 2010-10-26 | Rex Medical, L.P. | Rotational thrombectomy wire |
JP4834367B2 (en) * | 2005-09-29 | 2011-12-14 | 日本ライフライン株式会社 | Guide wire and manufacturing method thereof |
WO2008057554A1 (en) | 2006-11-08 | 2008-05-15 | Cook Incorporated | Thrombus removal device |
US8439937B2 (en) | 2007-06-25 | 2013-05-14 | Cardiovascular Systems, Inc. | System, apparatus and method for opening an occluded lesion |
US8361095B2 (en) | 2009-02-17 | 2013-01-29 | Cook Medical Technologies Llc | Loop thrombectomy device |
US20110077673A1 (en) | 2009-09-29 | 2011-03-31 | Cardiovascular Systems, Inc. | Rotational atherectomy device with frictional clutch having magnetic normal force |
US9023070B2 (en) | 2010-05-13 | 2015-05-05 | Rex Medical, L.P. | Rotational thrombectomy wire coupler |
US8663259B2 (en) | 2010-05-13 | 2014-03-04 | Rex Medical L.P. | Rotational thrombectomy wire |
US8764779B2 (en) | 2010-05-13 | 2014-07-01 | Rex Medical, L.P. | Rotational thrombectomy wire |
-
2004
- 2004-12-20 US US11/017,112 patent/US7819887B2/en active Active
-
2005
- 2005-11-02 WO PCT/US2005/039856 patent/WO2006055265A1/en active Application Filing
- 2005-11-02 EP EP05816969.9A patent/EP1811908B1/en active Active
- 2005-11-02 AU AU2005306899A patent/AU2005306899B2/en not_active Ceased
- 2005-11-02 ES ES05816969.9T patent/ES2455515T3/en active Active
- 2005-11-02 JP JP2007543096A patent/JP2008520351A/en active Pending
- 2005-11-02 CA CA002588152A patent/CA2588152A1/en not_active Abandoned
-
2010
- 2010-08-11 US US12/854,378 patent/US8062317B2/en active Active
-
2011
- 2011-10-19 US US13/276,398 patent/US8465511B2/en active Active
-
2012
- 2012-10-18 JP JP2012230533A patent/JP5404892B2/en active Active
-
2013
- 2013-06-02 US US13/907,953 patent/US9474543B2/en active Active
-
2016
- 2016-09-20 US US15/270,606 patent/US10117671B2/en active Active
Also Published As
Publication number | Publication date |
---|---|
ES2455515T3 (en) | 2014-04-15 |
US10117671B2 (en) | 2018-11-06 |
EP1811908A1 (en) | 2007-08-01 |
JP2013017834A (en) | 2013-01-31 |
EP1811908B1 (en) | 2014-01-08 |
JP5404892B2 (en) | 2014-02-05 |
US7819887B2 (en) | 2010-10-26 |
US8062317B2 (en) | 2011-11-22 |
AU2005306899B2 (en) | 2011-05-26 |
US8465511B2 (en) | 2013-06-18 |
US20100305592A1 (en) | 2010-12-02 |
US20120035634A1 (en) | 2012-02-09 |
US20060106407A1 (en) | 2006-05-18 |
US9474543B2 (en) | 2016-10-25 |
US20170007290A1 (en) | 2017-01-12 |
US20130267844A1 (en) | 2013-10-10 |
JP2008520351A (en) | 2008-06-19 |
WO2006055265A1 (en) | 2006-05-26 |
AU2005306899A1 (en) | 2006-05-26 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US10117671B2 (en) | Rotational thrombectomy device | |
US10517630B2 (en) | Rotational thrombectomy wire | |
US10064645B2 (en) | Rotational thrombectomy wire | |
EP2422719B1 (en) | Rotational thrombectomy wire with blocking device | |
CA2421491C (en) | Rotational thrombectomy device | |
EP2700368B1 (en) | Rotational thrombectomy wire |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
EEER | Examination request | ||
FZDE | Discontinued |
Effective date: 20160623 |
|
FZDE | Discontinued |
Effective date: 20160623 |