Closure medical device

• US 7,731,732 B2
• Filed: 08/31/2007
• Issued: 06/08/2010
• 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.
• Primary Examiner(s): Ho; (Jackie) Tan-Uyen T
• Assistant Examiner(s): DANG, PHONG SON H
• Application Number:
  US11/849,252
• Publication Number:
  US 20090062848A1
• Time in Patent Office: 1,012 Days
• Field of Search: 606/213, 606/215, 606231-233, 606/151, 606153-154, 128/898, 623/23.72
• 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. One variation of the device provides for removing the distal section from the vessel so that it resides also in the tissue tract after the proximal section has been securely bunched and lodged within the tissue tract in order to provide unobstructed fluid flow in the vessel.

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 within 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 middle section connected to said distal section so that upon rotation of said distal section, said middle section exterior to said vessel or cavity, remaining in connection with said distal section,

(c) a proximal section connected to said middle 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,

(d) 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

(e) 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,

(f) 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,

(g) said first tension member capable of withdrawing said distal section from inside said vessel or cavity to be next to and folded into said middle section within said tissue tract, thereby removing said distal section from said vessel or cavity.

2. The closure device of claim 1, further comprising a plunger for bunching said proximal 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 proximal to said proximal section and 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 proximal to said proximal section and 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 within 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 middle section connected to said distal section so that upon rotation of said distal section, said middle section exterior to said vessel or cavity, remaining in connection with said distal section,

(c) a proximal section connected to said middle 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,

(d) 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

(e) 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,

(f) 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,

(g) said first tension member capable of withdrawing said distal section from inside said vessel or cavity to be next to and folded into said middle section within said tissue tract, thereby removing said distal section from said vessel or cavity,

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,

placing said rotated distal section against said interior of said vessel or cavity by pulling back on said delivery sheath and pushing on said plunger 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 tension member and pushing said plunger, thereby providing closure for said puncture wound.

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 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 within 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 middle section connected to said distal section so that upon rotation of said distal section, said middle section exterior to said vessel or cavity, remaining in connection with said distal section,

(c) a proximal section connected to said middle 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,

(d) 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

(e) 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,

(f) said first tension member capable of withdrawing said distal section from inside said vessel or cavity to be next to and folded into said middle section within said tissue tract, thereby removing said distal section from said vessel or cavity,

said mechanism comprising a delivery sheath having distal and proximal ends, a plunger for providing pushing in a distal direction towards a vessel opening 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 members 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 middle section so that upon rotation of said distal section, said middle section resides exterior to said vessel or cavity, remaining in connection with said distal section,

a long bunchable back section connected to said middle section that bunches upon deployment from said delivery sheath using a 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,

wherein said short stiff front section bends at a midline using tension on said first tension member after said long bunchable back section is bunched using a second tension member, using said tension from said first tension member to withdraw said short stiff front section from said interior opening and bend it into said tissue tract in front of said long bunched back section, thereby clearing said vessel of said device and providing unobstructed fluid flow in said vessel and wound healing 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 proximal to said proximal section and 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.