CLOSURE MEDICAL DEVICE

• US 20090062847A1
• Filed: 08/31/2007
• Published: 03/05/2009
• Est. Priority Date: 08/31/2007
• Status: Active Grant

• Current Assignee: Christopher G.M. Ken
• Original Assignee: Christopher G.M. Ken
• Inventors: Ken, Christopher G.M.
• Granted Patent: US 7,771,455 B2
• Time in Patent Office: Days
• US Class Current: 606/213
• CPC Class Codes: A61B 17/0057 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 sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/2939 Details of linkages or pivot points

Abstract

A closure device for closing a puncture wound has a distal section that can be placed against the interior wall of a vessel and a proximal section that bunches in the tissue tract to close the wound.

Claims

1. A closure device for closing a puncture wound, said device deliverable in a delivery sheath, said puncture wound having a length along a tissue tract that resolves in an interior opening of a vessel or cavity, said closure device comprising:

(a) a distal section for placing inside said interior opening of said vessel or cavity, said distal section lodged in a delivery sheath having proximal and distal ends, said delivery sheath capable of penetrating said wound along said length of said wound to pass through said interior opening and release said distal section, said released distal section capable of rotation of about 90 degrees to provide resistance against said interior opening,

(b) a proximal section connected to said distal section, said proximal section comprising a bunchable material capable of bunching in said tissue tract upon deployment, said proximal section also released from said delivery sheath in an unbunched state, bunchable upon release,

(c) a first tension member connected to said distal section for rotating said distal section 90 degrees inside said vessel or cavity and placing said distal section inside said interior opening of said vessel or cavity to provide resistance against said interior opening,

(d) a second tension member connected to said proximal section for bunching said bunchable material of said proximal section within said tissue tract, thereby closing said puncture wound and

(d) a plunger lodged within said delivery sheath for rotating said distal section 90 degrees In coordination with said first tension member by pushing said plunger towards said distal section and pulling said first tension member against the pushing of said plunger,

thereby closing said puncture wound with said distal section rotated 90 degrees inside said vessel or cavity and said proximal section bunched in said tissue tract.

2. The closure device of claim 1, further comprising that said plunger is also capable of bunching said proximal section after rotation of said distal section by pushing distally with said plunger while said second tension member is pulled proximally.

3. The closure device of claim 1, wherein said first tension member is looped through said distal section and said second tension member is looped through said proximal section each using a single tension member having first and second proximal ends.

4. The closure device of claim 2, wherein said first tension member is looped through said distal section and said second tension member is looped through said proximal section each using a single tension member having first and second proximal ends.

5. The closure device of claim 1, wherein said first tension member passes through said distal section and said second tension member passes through said proximal section once and is knotted at an end closest to the puncture hole in the vessel, said tension members each having a single end residing close to said skin surface.

6. The closure device of claim 2, wherein said first tension member passes through said distal section once and is knotted at an end closest to the puncture hole in the vessel and said second tension member passes through said proximal section once and is knotted at an end closest to the puncture hole in the vessel, said tension members each having a single end residing close to said skin surface.

7. The closure device of claim 3, wherein said looped second tension member is attached to itself by a slip knot of a first end around a second end, said slip knot being close to the skin surface.

8. The closure device of claim 4, wherein said looped second tension member is attached to itself by a slip knot of a first end of the tension member around a second end of the tension member.

9. The closure device of claim 2, wherein said looped first tension member is fixed by one knot in a first end of the first tension member.

10. The closure device of claim 2, wherein said looped second tension member is fixed by one knot in a first end of the second tension member.

11. The closure device of claim 4, wherein said looped second tension member is fixed by one knot in a first end of the second tension member.

12. The closure device of claim 1, wherein said distal and proximal sections comprise a material selected from the group consisting of polyglycolytic acid (PGA), PGLA, PLA, polydioxanone, polycaprolactone, polyhydroxybutyrate, collagen, a polymer matrix, extracellular matrix, silk, Dacron, PTFE, EPTFE, a bioabsorbable material, a biodegradable material, a biocompatible material, a metal, a metal alloy, a plastic, an elastic material, a polymer, an inert material, a fused segment of material, a melted segment of material, a fabric, a braid, a weave, and a foldable material.

13. The closure device of claim 1, wherein said tension member comprises a material selected from the group consisting of polyglycolytic acid (PGA), PGLA, PLA, polydioxanone, polycaprolactone, polyhydroxybutyrate, collagen, a polymer matrix, extracellular matrix, silk, Dacron, suture, a bioabsorbable material, a biodegradable material, a biocompatible material, a metal, a metal alloy, a plastic, an elastic material, a polymer, an inert material, a thread, and a strand.

14. A method of closing a puncture wound, said wound having a length along a tissue tract running from a skin surface and resolving at an interior opening of a vessel or cavity comprising:

placing the closure device for closing a puncture wound into a delivery sheath and placing said delivery sheath into an introducer sheath in said tissue tract, and directing said delivery sheath to said interior opening of said vessel or cavity, said device deliverable in a delivery sheath, said puncture wound having a length along a tissue tract that resolves in an interior opening of a vessel or cavity, said closure device comprising;

(a) a distal section for placing inside said interior opening of said vessel or cavity, said distal section lodged in a delivery sheath having proximal and distal ends, said delivery sheath capable of penetrating said wound along said length of said wound to pass through said interior opening and release said distal section, said released distal section capable of rotation of about 90 degrees to provide resistance against said interior opening,

(b) a proximal section connected to said distal section, said proximal section comprising a bunchable material capable of bunching in said tissue tract upon deployment, said proximal section also released from said delivery sheath in an unbunched state, bunchable upon release,

(c) a first tension member connected to said distal section for rotating said distal section 90 degrees inside said vessel or cavity and placing said distal section inside said interior opening of said vessel or cavity to provide resistance against said interior opening,

(d) a second tension member connected to said proximal section for bunching said bunchable material of said proximal section within said tissue tract, thereby closing said puncture wound, and

(e) a plunger for pushing said distal section into said vessel and rotating it 90 degrees in coordination with a pulling of said first tension member, and for bunching said proximal section by pushing distally with said plunger while said second tension member is pulled proximally toward the skin surface,

pushing said plunger positioned within said delivery sheath distally enough to deploy said distal section in said vessel,

rotating said distal section about 90 degrees inside said vessel or cavity while pulling said tension member and pushing on said plunger,

placing said rotated distal section against said interior of said vessel or cavity by pulling back on said delivery sheath until said rotated distal section seats against the vessel wall,

withdrawing said introducer sheath and delivery sheath gradually along said tissue tract, pushing said plunger lodged within said delivery sheath distally to release said proximal section in said tissue tract, and

bunching said proximal section by pulling said second tension member and pushing said plunger, thereby providing closure for said puncture wound along the tissue tract.

15. The method of claim 14, further comprising the step of locking said delivery sheath within said introducer sheath.

16. The method of claim 14, further comprising removing said delivery sheath, introducer sheath, and plunger after said proximal section is bunched.

17. The method of claim 14, further comprising clipping said tension member at said skin surface.

18. A mechanism for delivering a closure device to a tissue tract that resolves in a puncture wound in a vessel or cavity, said closure device comprising:

(a) a distal section for placing Inside said interior opening of said vessel or cavity, said distal section lodged in a delivery sheath having proximal and distal ends, said delivery sheath capable of penetrating said wound along said length of said wound to pass through said interior opening and release said distal section, said released distal section capable of rotation of about 90 degrees to provide resistance against said interior opening,

(b) a proximal section connected to said distal section, said proximal section comprising a bunchable material capable of bunching in said tissue tract upon deployment, said proximal section released from said delivery sheath in an unbunched state, bunchable upon release,

(c) a first tension member connected to said distal section for rotating said distal section 90 degrees inside said vessel or cavity and placing said distal section inside said interior opening of said vessel or cavity to provide resistance against said interior opening, and

(d) a second tension member connected to said proximal section for bunching said bunchable material of said proximal section within said tissue tract, thereby closing said puncture wound, and

said mechanism comprising a delivery sheath having distal and proximal ends, a plunger for providing pushing in a distal direction towards said interior opening in the vessel in order to place said distal section In said vessel opening and said proximal section in said tissue tract, and a tension member control arm at said proximal end for allowing pull on said tension member to place said distal section and bunch said proximal section.

19. A closure device for closing a puncture wound, said device deliverable in a delivery sheath, said puncture wound having a length along a tissue tract that resolves in an interior opening of a vessel having fluid flow, said closure device comprising:

a short stiff front section capable of rotation 90 degrees upon deployment from said delivery sheath and upon pushing of a plunger also lodged in said delivery sheath capable of placement inside said vessel for seating said device in said vessel, said short front section having a first tension member and said short front section connected to

a long bunchable back section that bunches upon deployment from said delivery sheath using said plunger to push it out from said delivery sheath in a plunging action and a second tension member running through the bunchable section to pull against said seated front section in opposition to said plunging action to release said long back section from said delivery sheath and to bunch it in said tissue tract.

20. The device of claim 19, wherein said distal and proximal sections comprise a material selected from the group consisting of polyglycolytic acid (PGA), PGLA, PLA, polydioxanone, polycaprolactone, polyhydroxybutyrate, collagen, a polymer matrix, extracellular matrix, silk, Dacron, PTFE, EPTFE, a bioabsorbable material, a biodegradable material, a biocompatible material, a metal, a metal alloy, a plastic, an elastic material, a polymer, an inert material, a fused segment of material, a melted segment of material, a fabric, a braid, a weave, and a foldable material.

21. The closure device of claim 19, wherein said tension member comprises a material selected from the group consisting of polyglycolytic acid (PGA), PGLA, PLA, polydioxanone, polycaprolactone, polyhydroxybutyrate, collagen, a polymer matrix, extracellular matrix, silk, Dacron, suture, a bioabsorbable material, a biodegradable material, a biocompatible material, a metal, a metal alloy, a plastic, an elastic material, a polymer, an inert material, a thread, and a strand.

22. The device of claim 19, wherein said second tension member is looped through said proximal section and having first and second proximal ends residing close to the skin surface.

23. The device of claim 22, wherein said looped tension member is attached to itself by a slip knot of a first end of the tension member around a second end of the tension member.

24. The device of claim 19, wherein said second tension member passes through said proximal section once and is knotted close to the puncture hole in the vessel, said tension member having a single end close to said skin surface.

25. The device of claim 19, wherein said second tension member is fixed by one knot in a first end of the tension member close to said puncture hole in the vessel.