Medical grafting methods and apparatus

• US 6,206,912 B1
• Filed: 08/04/1999
• Issued: 03/27/2001
• Est. Priority Date: 11/07/1996
• Status: Expired due to Term

• Current Assignee: St Jude Medical ATG Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Anastomotic Technology Group Incorporated
• Inventors: Mazzocchi, Rudy, Sullivan, Daniel J., Bachinski, Thomas J., Goldsteen, David S.
• Primary Examiner(s): Isabella, David J.
• Assistant Examiner(s): Koh, Choon P.
• Application Number:
  US09/368,191
• Time in Patent Office: 601 Days
• Field of Search: 606/108, 606/151, 623/1.23, 623/903
• US Class Current: 623/1.23
• CPC Class Codes: A61B 1/0058 using shape-memory elements
• 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 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/32056 Surgical snare instruments for removing or smashing calculi A61B2017/2212; tonsillotomes A61B17/26
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/2939 Details of linkages or pivot points
• CPC Class Codes: A61B 2090/306 using optical fibres
• CPC Class Codes: A61B 2090/3614 using optical fibre
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 : Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/061 : provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/065 : Y-shaped blood vessels
• CPC Class Codes: A61F 2002/3008 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30092 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/826 : more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/8486 : provided on at least one of the ends
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2240/001 : Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 2025/0293 : Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube natural lumen, e.g. vessels A61M25/04
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/0041 : pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0108 : using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0133 : Tip steering devices
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0152 : with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61M 25/04 : in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/09025 : with sliding mandrils
• CPC Class Codes: Y10S 623/903 : Blood vessel

Abstract

Methods and apparatus for delivering and installing a new length of tubing between two sections of a patient'"'"'s existing body organ tubing and at least partly outside of that existing structure. For example, the new length of tubing may be for the purpose of providing the patient with a coronary bypass. The new tubing may be an artificial graft, a natural graft (harvested elsewhere from the patient), or both. The new tubing is delivered to and installed at the operative site primarily by working through the patient'"'"'s existing tubular body organ structure. This avoids the need for any significant surgery on the patient. The artificial grafts may have shapes other than tubular. Certain procedural and apparatus aspects of the invention have uses other than in connection with grafting in general or tubular grafting in particular.

Claims

1. Apparatus for making a new tubular connection between first and second sections of a patient'"'"'s existing tubular body organ structure comprising:

first elongated instrumentation insertable axially into and along the interior of a portion of said existing structure to said first section where said first instrumentation produces an aperture through a first section to the outside of said patient'"'"'s existing structure; and

second elongated instrumentation insertable axially into and along the interior of a part of said existing structure for conveying said new length of tubing to and partly through said aperture in said first section and then outside of said existing structure to an aperture in said second section so that said new length of tubing attaches to said second section via said aperture in said second section and also attaches to said first section via said aperture in said first section, wherein said second elongated instrumentation is a catheter-type member.

2. The apparatus defined in claim 1 wherein said first and second instrumentation is substantially entirely controlled from outside of said patient.

3. The apparatus defined in claim 1 further comprising:

third elongated instrumentation insertable axially into and along the interior of a length of said existing structure to said second section where said third instrumentation produces said aperture through said second section to the outside of said existing structure.

4. The apparatus defined in claim 3 wherein said third instrumentation is substantially entirely controlled from outside of said patient.

5. The apparatus defined in claim 1 wherein said first instrumentation comprises:

a first tubular structure insertable into and along the interior of said portion of said existing structure; and

a first longitudinal structure insertable longitudinally into and along said first tubular structure and having a distal portion which is adapted for producing said aperture through said first section.

6. The apparatus defined in claim 5 wherein said second instrumentation is insertable longitudinally into and along said first tubular structure.

7. The apparatus defined in claim 6 wherein said second instrumentation is extendable through said aperture in said first section.

8. The apparatus defined in claim 5 wherein a distal portion of said first tubular structure is adapted for passage through said aperture in said first section after said first longitudinal structure has produced said aperture.

9. The apparatus defined in claim 8 wherein said distal portion of said first tubular structure includes an anchor structure for releasably securing said distal portion of said first tubular structure through said aperture in said first section.

10. The apparatus defined in claim 9 wherein said anchor structure comprises two axially spaced, annular, inflatable members on said distal portion, one of said inflatable members being inside said first section and the other of said inflatable members being outside of said first section when said distal portion is disposed through said aperture in said first section, each of said inflatable members being too large when inflated to pass through said aperture in said first section.

11. The apparatus defined in claim 8 wherein said distal portion of said first tubular structure includes a seal structure for providing a fluid-tight seal around said distal portion where said distal portion passes through said aperture in said first section.

12. The apparatus defined in claim 11 wherein said seal structure comprises two axially spaced, annular, inflatable members on said distal portion, one of said inflatable members being inside said first section and the other of said inflatable members being outside of said first section when said distal portion is disposed through said aperture in said first section, each of said inflatable members resiliently bearing on said first section annularly around said aperture when said inflatable members are inflated.

13. The apparatus defined in claim 1 wherein said second instrumentation comprises:

a second tubular structure insertable into and along the interior of said part of said existing structure; and

a second longitudinal structure insertable longitudinally into and along said second tubular structure and having a distal portion on which said new length of tubing is releasably disposed.

14. The apparatus defined in claim 1 wherein said new length of tubing includes selectively operable fasteners where said new length of tubing is to attach to said second section, and wherein said second instrumentation operates said fasteners to engage said second section when said new length of tubing is properly positioned for attachment to said second section.

15. The apparatus defined in claim 1 wherein said new length of tubing includes selectively operable fasteners where said new length of tubing is to attach to said first section, and wherein said second instrumentation operates said fasteners to engage said first section when said new length of tubing is to be attached to said first section.

16. The apparatus defined in claim 13 wherein said new length of tubing includes selectively operable fasteners where said new length of tubing is to attach to said second section, and wherein said second longitudinal structure comprises:

a circumferentially expandable structure for operating said fasteners to engage said second section.

17. The apparatus defined in claim 16 wherein said circumferentially expandable structure comprises an inflatable balloon.

18. The apparatus defined in claim 13 wherein said new length of tubing includes selectively operable fasteners where said new length of tubing is to attach to said first section, and wherein said second longitudinal structure comprises:

a circumferentially expandable structure for operating said fasteners to engage said first section.

19. The apparatus defined in claim 18 wherein said circumferentially expandable structure comprises an inflatable balloon.

20. The apparatus defined in claim 3 wherein said first instrumentation includes a first longitudinal structure having a distal portion which is axially extendable from the remainder of said first instrumentation through the aperture in said first section to the outside of said existing structure, and wherein said third instrumentation includes a second longitudinal structure having a distal portion which is axially extendable from the remainder of said third instrumentation through the aperture in said second section to the outside of said existing structure for interengagement with said distal portion of said first longitudinal structure outside of said existing structure.

21. The apparatus defined in claim 20 wherein one of said first and third instrumentations further includes an endoscope having a distal portion which is axially extendable to the outside of said existing structure through the aperture in the one of the first and second sections that is associated with said one of said instrumentations for facilitating interengagement between said distal portions of said first and second longitudinal structures.

22. The apparatus defined in claim 21 wherein said distal portion of said endoscope is laterally steerable from endoscope controls outside said patient.

23. The apparatus defined in claim 21 wherein said endoscope includes an illumination source for illuminating the interior of the patient adjacent said distal portion of said endoscope.

24. The apparatus defined in claim 21 wherein said endoscope transmits image information regarding the appearance of the interior of the patient adjacent the distal portion of said endoscope to a viewing location which is outside of said patient.

25. The apparatus defined in claim 21 wherein said endoscope is a video endoscope.

26. The apparatus defined in claim 21 wherein the distal portion of the one of said first and second longitudinal structures that is associated with said one of said first and third instrumentations that includes said endoscope is mounted relative to said distal portion of said endoscope so that said distal portion of said one of said first and second longitudinal structures can be moved with said distal portion of said endoscope.

27. The apparatus defined in claim 26 wherein, when said distal portion of said one of said first and second longitudinal structures is being moved with said distal portion of said endoscope, said distal portion of said one of said first and second longitudinal structures is also within the field of view of said endoscope.

28. The apparatus defined in claim 20 wherein the distal portion of one of said first and second longitudinal structures comprises:

a selectively closable snare for selectively closing around the distal portion of the other of said first and second longitudinal structures.

29. The apparatus defined in claim 28 wherein said snare comprises:

a tube having a distal end; and

a longitudinal member axially reciprocable within said tube and having a distal loop which is resiliently biased to open when said loop is distal of said distal end of said tube and which is closed by proximal retraction of said loop into said tube, said loop being large enough when open for the distal portion of the other of said first and second longitudinal structures to enter said loop, and said loop being small enough when closed to engage the distal portion of said other of said first and second longitudinal structures which has entered said loop.

30. The apparatus defined in claim 29 wherein said tube is large enough to receive both said loop and the distal portion of said other of said first and second longitudinal structures which has been engaged by said loop.

31. The apparatus defined in claim 20 wherein said first and third instrumentations permit said first and second longitudinal structures after interengagement to be shifted axially as a unit relative to said first and third instrumentations until one of said first and second longitudinal structures extends continuously between said apertures in said first and second sections.

32. The apparatus defined in claim 31 wherein said first and third instrumentations additionally permit said first and second longitudinal structures after interengagement to be shifted axially as a unit relative to said first and third instrumentations until only one of said first and second longitudinal structures extends continuously from outside said patient, through both of said first and third instrumentations, and then back out of said patient again.

33. The apparatus defined in claim 20 wherein said second instrumentation is adapted to travel axially along at least one of said first and second longitudinal structures after interengagement of those structures in order to enable a distal portion of said second instrumentation to find its way from the aperture in said first section to said aperture in said second section.

34. The apparatus defined in claim 33 wherein said new length of tubing is disposed substantially coaxially around said at least one of said first and second longitudinal structures in said third instrumentation.

35. The apparatus defined in claim 33 wherein said second instrumentation includes a distal portion which is adapted to enlarge the aperture in said second section to facilitate attachment of said new length of tubing to said second section via said aperture.

36. The apparatus defined in claim 34 wherein said second instrumentation comprises:

a delivery tube disposed substantially concentrically around said new length of tubing for facilitating entry of a distal portion of said new length of tubing into the aperture in said second section.

37. The apparatus defined in claim 36 wherein said new length of tubing includes selectively operable fasteners, and wherein said fasteners are rendered operable to attach said new length of tubing by proximal retraction of said delivery tube relative to said new length of tubing so that said fasteners are no longer within said delivery tube.

38. The apparatus defined in claim 37 wherein said fasteners are radially outwardly expandable to engage said second section around said aperture in said second section.

39. The apparatus defined in claim 38 wherein said second instrumentation includes a selectively circumferentially expandable structure disposed adjacent said fasteners for radially outwardly expanding said fasteners when said circumferentially expandable structure is circumferentially expanded.

40. The apparatus defined in claim 39 wherein said circumferentially expandable structure is an inflatable balloon.

41. The apparatus defined in claim 37 wherein said fasteners are radially outwardly expandable to engage said first section around said aperture in said first section.

42. The apparatus defined in claim 41 wherein said second instrumentation includes a selectively circumferentially expandable structure disposed adjacent said fasteners for radially outwardly expanding said fasteners when said circumferentially expandable structure is circumferentially expanded.

43. The apparatus defined in claim 42 wherein said circumferentially expandable structure is an inflatable balloon.

44. The apparatus defined in claim 20 wherein at least one of said longitudinal structures includes a plurality of longitudinally spaced radiologic markers for helping to measure path length outside of said existing structure between said apertures in said first and second sections.