Medical grafting methods

• US 5,976,178 A
• Filed: 11/07/1996
• Issued: 11/02/1999
• Est. Priority Date: 11/07/1996
• Status: Expired due to Term

• Current Assignee: St Jude Medical ATG Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Vascular Science, Inc. (Abbott Laboratories Incorporated)
• Inventors: Sullivan, Daniel J., Mazzocchi, Rudy, Bachinski, Thomas J., Goldsteen, David S.
• Primary Examiner(s): Isabella, David J.
• Assistant Examiner(s): Koh, Choon P.
• Application Number:
  US08/745,618
• Time in Patent Office: 1,090 Days
• Field of Search: 623/1, 623/11, 623/12, 600/8, 128/898, 604/49-54, 604/158, 604/159, 604/163, 604/164, 604/272, 606/108, 606/113, 606/185, 606/194-195
• US Class Current: 623/1.13
• 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. The method for forming a tubular graft connection between first and second sections of a patient'"'"'s existing tubular body organ structure comprising the steps of:

passing a length of graft tubing axially along an interior lumen of a portion of said existing structure to place a first end portion of said length of qraft tubing inside said first section of said existing structure;

causing said first end portion of said length of graft tubing to emerge from inside to outside of said first section of said existing structure via an aperture in a wall of said first section;

extending said first end portion of said length of graft tubing outside of said existing structure to an aperture in a wall of said second section of said existing structure;

securing said first end portion of said length of graft tubing to said second section of said existing structure; and

securing a portion of said length of graft tubing which is axially spaced from said first end portion to said first section of said existing structure.

2. The method defined in claim 1 wherein each of said steps is at least partly controlled from outside of the patient via instrumentation that passes through said existing structure to reach at least one of said first and second sections.

3. The method defined in claim 1 wherein said step of securing said first end portion of said length of graft tubing comprises the step of:

forming an anastomosis between said first end portion of said length of graft tubing and said second section of said existing structure.

4. The method defined in claim 1 wherein said step of securing a portion of said length of graft tubing which is axially spaced from said first end portion comprises the step of:

forming an anastomosis between said portion which is axially spaced and said first section of said existing structure.

5. The method defined in claim 1 wherein said length of graft tubing includes artificial graft tubing.

6. The method defined in claim 1 further comprising the step of:

removing a length of the patient'"'"'s natural body organ tubing for use as at least part of the length of graft tubing.

7. The method defined in claim 6 further comprising the step of:

disposing the natural body organ tubing substantially coaxially inside artificial graft tubing to provide said length of graft tubing.

8. The method defined in claim 1 wherein said steps of passing, causing, and extending are preceded by the step of:

positioning a longitudinal structure along the interior lumen of said portion of said existing structure and out of said existing structure via said aperture in said first section to said aperture in said second section.

9. The method defined in claim 8 wherein said steps of passing, causing, and extending are at least partly performed by moving said length of graft tubing along said longitudinal structure.

10. The method defined in claim 9 wherein said length of graft tubing is placed coaxially around said longitudinal structure in order to move said length of graft tubing along said longitudinal structure.

11. The method defined in claim 8 wherein said positioning step comprises the steps of:

passing a first length of the longitudinal structure along the interior lumen of said portion of said existing structure so that a distal portion of said first length extends out from said existing structure via said aperture in said first section;

passing a second length of longitudinal structure along the interior lumen of a part of said existing structure which is at least partly different from said portion of said existing structure so that a distal portion of said second length extends out from said existing structure via said aperture in said second section; and

interengaging said distal portion of said first length and said dislal portion of said second length at an interengagement location which is between said aperture in said first section and said aperture in said second section and outside of said existing structure.

12. The method in claim 11 wherein said positioning step further comprises the step of:

after performing said interengaging step, axially shifting the interengaging first and second lengths so that the interengagement location is no longer between said aperture in said first section and said aperture in said second section outside of said existing structure.

13. The method defined in claim 12 wherein said axially shifting is performed until said interengagement location is outside of the patient.

14. The method defined in claim 1 wherein said steps of passing and causing are preceded by the step of:

positioning a tubular instrument along the interior lumen of said portion of said existing structure and out of said existing structure via said aperture in said first section.

15. The method defined in claim 14 wherein said steps of passing, causing, and extending are at least partly performed by moving said length of draft tubing through said tubular instrument.

16. The method defined in claim 1 wherein said length of graft tubing is disposed in a delivery tube instrument during said passing, causing, and extending steps, and wherein said method further comprises the step of removing said delivery tube instrument from said length of graft tubing prior to completion of said securing steps.

17. The method defined in claim 1 wherein said length of graft tubing includes selectively operable fasteners, and wherein said step of securing said first end portion comprises the step of:

operating fasteners adjacent to said second section to fasten said first end portion to said second section.

18. The method defined in claim 17 wherein said operating step causes said fasteners adjacent to said second section to extend radially outward from said length of graft tubing into said second section.

19. The method defined in claim 17 wherein said fasteners adjacent to said second section are disposed in an annular array which is substantially concentric with said length of graft tubing, and wherein said operating step comprises the step of:

circumferentially expanding said annular array into engagement with said second section.

20. The method defined in claim 17 wherein said operating step comprises the steps of:

disposing an inflatable member inside said length of graft tubing adjacent to said fasteners adjacent to said second section; and

inflating said inflatable member to help said fasteners securely engage said second section.

21. The method defined in claim 20 wherein said operating step further comprises the step of:

deflating said inflatable member after performing said inflating step.

22. The method defined in claim 1 wherein said length of graft tubing includes selectively operable fasteners, and wherein said step of securing a portion of said length of graft tubing to said first section comprises the step of:

operating fasteners adjacent to said first section to fasten said portion of said length of graft tubing which is axially spaced from said first end portion to said first section.

23. The method defined in claim 22 wherein said operating step causes said fasteners adjacent to said first section to extend radially outward from said length of graft tubing into said first section.

24. The method defined in claim 22 wherein said fasteners adjacent to said first section are disposed in an annular array which is substantially concentric with said length of graft tubing, and wherein said operating step comprises the step of:

circumferentially expanding said annular array into engagement with said first section.

25. The method defined in claim 22 wherein said operating step comprises the steps of:

disposing an inflatable member inside of said length of graft tubing adjacent to said fasteners adjacent to said first section; and

inflating said inflatable member to help said fasteners securely engage said first section.

26. The method defined in claim 25 wherein said operating step further comprises the step of:

deflating said inflatable member after performing said inflating step.

27. A method of providing a tubular graft connection between first and second tubular bode organ sections in a patient comprising the steps of:

inserting a first elongated instrument substantially coaxially into said first tubular body organ section;

inserting a second elongated instrument substantially coaxially into said second tubular body organ section;

extending a first longitudinal structure from said first instrument so that a distal portion of said first structure passes through a wall of said first tubular body organ section;

extending a second longitudinal structure from said second instrument so that a distal portion of said second structure passes through a wall of said second tubular body organ section;

interengaging said distal portions of said first and second structures outside of said first and second tubular body organ sections; and

extending a length of graft tubing along at least one of said first and second structures so that said length of graft tubing extends between said first and second body organ sections outside of said first and second body organ sections.

28. The method defined in claim 27 wherein said interengaging step takes place inside the body of the patient, and wherein said length of graft tubing extends between said first and second body organ sections outside of said first and second body organ sections but inside the body of the patient as a result of performing said step of extending a length of graft tubing.

29. The method defined in claim 27 wherein all of said extending and interengaging steps are performed inside the body of the patient under remote control from outside the patient via at least one of said first and second instruments.

30. The method defined in claim 27 further comprising the step of:

after performing said interengaging step, longitudinally displacing the interengaged first and second structures so that said one of said first and second structures extends continuously between said first and second tubular body organ sections outside of said first and second tubular body organ sections.

31. The method defined in claim 27 further comprising the step of:

after performing said step of extending said length of graft tubing, securing each end of said length of graft tubing to a respective one of said first and second tubular body organ sections so that said length of graft tubing opens into both of said first and second tubular body organ sections.

32. The method defined in claim 27 further comprising the step of:

after performing said step of extending said length of graft tubing, longitudinally withdrawing from the patient any of said first and second structures that remain in the patient.

33. The method defined in claim 32 further comprising the step of:

after performing said longitudinally withdrawing step, removing said first and second instruments from the patient.

34. The method defined in claim 27 further comprising the step of:

removing from the patient body organ tubing for use in said length of graft tubing.

35. The method defined in claim 27 wherein said length of graft tubing comprises an artificial graft.

36. The method defined in claim 35 further comprising the step of:

disposing natural body organ tubing coaxially inside of said artificial graft.

37. The method defined in claim 36 wherein said step of extending a length of graft tubing comprises the steps of:

extending said artificial graft along at least one of said first and second structures so that said artificial graft extends between said first and second body organ sections outside of said first and second body organ sections; and

extending said natural body organ tubing along at least one of said first and second structures so that said natural body organ tubing extends between said first and second body organ sections inside of said artificial graft.

38. The method defined in claim 35 further comp rising the step of:

after performing said step of extending said artificial graft, securing each end of said artificial graft to a respective one of said first and second tubular stody organ sections so that said artificial graft opens into both of said first and second tubular body organ sections.

39. The method defined in claim 38 further comprising the step of:

after performing said step of extending said natural body organ tubing, securing each end of said natural body organ tubing to a respective one of said first and second tubular body organ sections so that said natural body organ tubing opens into both of said first and second tubular body organ sections.

40. The method defined in claim 27 wherein the distal portion of one of said first and second structures has a selectively closable snare for engaging the distal portion of the other of said first and second structures when the snare is closed on the distal portion of said other structure, and wherein said interengaging step comprises the steps of:

positioning the distal portions of said first and second structures relative to one another so that said snare can engage the distal portion of said other structure; and

closing said snare.