Temporary seal and method for facilitating anastomosis

• US 20060206121A1
• Filed: 09/27/2004
• Published: 09/14/2006
• Est. Priority Date: 12/26/2001
• Status: Active Grant

• Current Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Original Assignee: Origin Medsystems, LLC
• Inventors: Taylor, Charles S., Chin, Albert K., Morejohn, Dwight
• Granted Patent: US 7,544,203 B2
• Time in Patent Office: Days
• US Class Current: 606/153
• 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 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12027 Type of occlusion A61B17/12113 takes precedence
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 2017/00362 Packages or dispensers for MIS instruments A61B2017/0479 takes precedence
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/0061 Implements located only on one side of the opening
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00641 for closing fistulae, e.g. anorectal fistulae
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/1107 for blood vessels

Abstract

Forming a proximal anastomosis on an aortic wall includes method and instrumentation and apparatus for forming an aortic puncture and inserting a fluid-impervious sealing element with a lateral flange and central stem into the vessel through the puncture. An anastomosis of a graft vessel over the puncture is partially completed with the central stem of the sealing element protruding through the partial anastomosis. A removal instrument attaches to the central stem and retrieves the sealing element that disassembles in helical disassociation of the flange and stem into a continuous strand that is withdrawn from the partial anastomosis prior to completion of the procedure.

Claims

1. A method for forming a sealing element for insertion and removal with respect to a fluid-carrying vessel of a patient, the method comprising:

forming fluid-impervious flange extending radially from a central region to a substantially circular periphery; and

including

forming a continuous disassociation region along a meandering path from the central region to the circular periphery.

2. The method according to claim 1 including

forming a central stem on the flange and integral therewith along the continuous dissociation region.

3. The method according to claim 1 including

forming an attachment structure near a proximal end of the stem for exerting tensile force thereon.

4. The method according to claim 1 in which the flange is formed as a continuously-wound spiral of thermoplastic material having contiguous lateral edges along adjacent convolutes;

and

selectively heating and pressing together the lateral edges of contiguous convolutes to lightly adhere the convolutes to form the fluid-impervious flange of the sealing element.

5. The method according to claim 1 in which the flange is formed with a continuous disassociation pattern of reduced thickness of the flange from a central region thereof to the periphery thereof for promoting disassembly of the flange along the disassociation pattern into a continuous strand from the central region to the periphery of the flange in response to force applied at the central region in relation to the flange.

6. A method of forming a temporary fluid-impervious sealing element comprising:

configuring a strand along a path and including an axial stem and a substantially lateral flange, with the path continuously meandering between the stem and an outer periphery of the flange; and

adhering contiguous adjacent segments of the strand in the stem and flange to form the fluid-impervious sealing element.

7. The method according to claim 6 in which the path substantially spirals between the stem and periphery of the flange with adjacent convolutes of the strand disposed in substantially contiguous array along the path.

8. The method according to claim 7 in which the strand includes thermoplastic material;

and

adhering includes applying heat and pressure at least to the flange to flow the material into fluid impervious attachments of contiguous adjacent convolutes of the strand.

9. A method for establishing a temporary fluid-tight seal within an aperture in a wall of a fluid-carrying vessel in the body of a patient, the method comprising:

introducing through the aperture a sealing element having a flange of substantially circular periphery and stem substantially normal to the flange in a central region thereof; and

exerting a supporting force through the aperture on one of the stem and flange for retaining fluid-sealing engagement of the circular periphery of the flange against an inner wall of the vessel covering the aperture.

10. The method according to claim 9 in which the flange of the sealing element includes substantially convex shape intruding into the vessel with the circular periphery thereof disposed about the aperture.

11. The method according to claim 9 in which a resilient member is disposed on an outer wall of the vessel and in which a tether is disposed in tension on the resilient member and extends through the aperture for attachment with the one of the stem and flange to exert the supporting force thereon.

12. A temporary sealing element for forming a fluid-tight seal on the inner wall of a fluid conduit within a patient'"'"'s body, the temporary sealing element comprising:

a fluid impervious flange having an outer stem centrally formed thereon, the flange including a continuous region of diminished shear strength extending from the stem along a continuous path to the periphery for selectively reconfiguring the flange in response to tension applied to the stem to dissemble the flange along the continuous region into a continuous strand.

13. The temporary sealing element according to claim 12 including a length of flexible, resilient material integrally forming the stem, and being helically wound to form successive convolutes outwardly from the stem to the periphery, with each convolute adhering to adjacent convolutes along lateral edges thereof to form the continuous region in the substantially fluid-impervious flange.

14. The temporary sealing element according to claim 13 in which the length of material includes a length of bioinert thermoplastic material forming the stem and flange and including thermoplastic adhesion between lateral edges of adjacent convolutes of the helically-wound length of material.

15. The temporary sealing element according to claim 13 in which the thermoplastic material is polyvinyl chloride.

16. The temporary sealing element according to claim 13 including an attachment structure at an end of the stem remote from the flange for selective engagement therewith to exert tensile force thereon.

17. The temporary sealing element according to claim 13 including a support structure attached to one of the stem and flange and including a resilient member disposed to expand from a confined configuration of smaller lateral dimension than the periphery of the flange to an expanded configuration of larger lateral dimension than the periphery of the flange.

18. The temporary sealing element according to claim 17 in which the resilient member extends laterally and includes a pair of mating ends disposed to traverse the periphery of the flange;

and

a strand attached to the mating ends and to one of the stem and flange for supporting the stem and flange intermediate the mating ends of the resilient member.

19. The temporary sealing element according to claim 18 in which the resilient member includes a pair of arms extending to and including the mating ends and resiliently biased for outward extension of the mating ends.

20. The temporary sealing element according to claim 12 in which the flange is formed of flexible resilient material and includes a generally circular periphery and the stem integrally formed therewith;

and in which the region of diminished shear strength extends from the stem along a substantially helical path to the periphery.

21. A seal removal instrument for the temporary sealing element of claim 16 including an elongated hollow tube having a lumen therethrough between distal and proximal ends dimensioned to pass the stem and attachment structure therethrough;

an inner core slidably disposed within the tube and including an attachment structure at a distal end thereof to mate with the attachment structure at the end of the stem for exerting tensile force thereon;

said tube being positionable about the stem with the distal end of the tube disposed adjacent the flange and with the attachment structures of the inner core and stem engaged to exert tensile force on the inner core relative to the tube for extracting the stem and flange through the outer tube as the continuous strand.

22. The seal removal instrument of claim 21 in which the attachment structure on the stem includes a loop, and the attachment structure on the inner core includes a hook for engaging the loop.

23. A punch for forming an aperture in the wall of the fluid-carrying vessel in a patient'"'"'s body, the punch comprising:

an elongated hemostatic sheath including a lumen therethrough between distal and proximal ends thereof;

a plunger element slidably and rotatably disposed within the lumen through the hemostatic sheath and carrying a tissue-penetrating member for selective axial extension thereof beyond the distal end of the hemostatic sheath to penetrate the wall of a fluid-carrying vessel.

24. A punch according to claim 23 in which the tissue-penetrating member includes a corkscrew-style tissue penetrator and includes a substantially circular cutting edge in close proximity thereto mounted for relative rotational motion therebetween.

25. A punch accordingly to claim 23 including a valve disposed in the hemostatic sheath for inhibiting outflow of fluid therethrough.

26. A punch according to claim 24 in which the distal end of the hemostatic sheath forms the cutting edge in close proximity to the tissue penetrator.

27. A kit of surgical components for anastomosing a graft vessel on a fluid-carrying vessel, comprising:

a punch for forming an aperture in a fluid-carrying vessel;

a sealing element including a continuous strand of material extending along a path forming an axial stem and a substantially lateral flange to a perimeter thereof of dimension greater than an aperture formable by the punch; and

an insertion instrument incorporating the sealing element in configuration for positioning the sealing element within an aperture formable by the punch.

28. The kit according to claim 27 including an extraction instrument having a lumen extending therethrough of sufficient dimension between proximal and distal ends thereof for passing the strand of material therethrough.

29. The kit according to claim 27 including a resilient frame disposed about the sealing element and including a flexible tether that is tensioned by the frame and that engages the sealing element in a combined structure of sealing element supported by the tether on the resilient frame.

30. The kit according to claim 29 in which the insertion instrument includes an elongated hollow tube having proximal and distal ends, with the combined structure confined within the hollow tube near the distal end thereof in compressed configuration for selective deployment therefrom to a configuration that tensions the tether for supporting the sealing element on the resilient frame.

31. The kit according to claim 27 including an envelope surrounding the punch and sealing element and insertion instrument for maintaining a sterile environment thereabout.

32. A method for preparing for insertion into a vessel an anastomotic seal having a resilient fluid-impervious flange and a stem attached thereto and having a resilient member including a pair of mating ends tethered by a strand attached in tension therebetween and attached to one of the flange and stem, the method comprising:

confining the resilient member within a tube with the mating ends in substantially contiguous orientation with the strand therebetween untensioned; and

confining the flange and stem within the tube in substantially tandem orientation relative to the resilient member.

33. The method according to claim 32 in which the flange confined within the tube is rolled laterally across a diameter thereof, with the stem oriented in substantial alignment with the roll axis of the flange.

34. The method according to claim 32 including a plunger axially slidable within the tube and comprising:

orienting the plunger at a position within the tube remote from distal end thereof in tandem proximity to the resilient member, with the flange of the seal disposed near the distal end of the tube.

35. The method according to claim 34 including sliding the plunger axially within the tube toward the distal end thereof to eject from the tube at least the flange and stem of the seal, the resilient member tethered to the seal between mating ends thereof being selectively retrieved from the tube to resiliently expand and tension the strand.

36. Apparatus for forming a temporary seal within a blood vessel, comprising:

a tube having a bore therein and including a plunger axially slidable within the bore;

a fluid-impervious flange of resilient material disposed within the bore near a distal end thereof, the flange having a stem extending substantially normally therefrom and rolled laterally substantially about a diameter of the flange with the stem extending within the bore proximally from the distal end thereof;

a resilient member confined within the bore intermediate the flange and plunger, the resilient member including a pair of arms extending to mating ends for tensioning a strand attached thereto and to one of the flange and stem, the pair of arms being disposed within the bore in substantially contiguous orientation with the strand untensioned between the mating ends.

37. Apparatus according to claim 36 in which the pair of arms are resiliently extendable substantially about a pivot axis positioned within the bore adjacent the plunger with the mating ends disposed near the flange for deployment from the distal end of the bore of at least the flange and stem in response to axial movement of the plunger toward the distal end of the bore.