Medical grafting methods and apparatus

• US 7,578,829 B2
• Filed: 10/06/2003
• Issued: 08/25/2009
• Est. Priority Date: 11/07/1996
• Status: Expired due to Fees

• Current Assignee: St Jude Medical ATG Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical ATG Incorporated (Abbott Laboratories Incorporated)
• Inventors: Mazzocchi, Rudy, Sullivan, Daniel J., Bachinski, Thomas J., Goldsteen, David S.
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US10/680,036
• Publication Number:
  US 20040116946A1
• Time in Patent Office: 2,150 Days
• Field of Search: 623/1.14, 606153-156
• US Class Current: 606/153
• 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. An assembly comprising:

a tubular graft conduit; and

a connector for use in making an artificial, fluid-tight connection between an end portion of the tubular graft conduit and a side wall of a tubular body conduit in a patient via an artificially formed aperture in the side wall of the tubular body conduit so that the tubular graft conduit extends from the tubular body conduit outside of the tubular body conduit and the patient'"'"'s body fluid can flow between lumens of the tubular graft conduit and the tubular body conduit via the connection, the connector comprising;

a structure that forms a continuous ring that is annularly enlargeable and disposed substantially concentrically with the tubular graft conduit, the structure including;

(a) a plurality of cantilevered, longitudinal, tissue-piercing members disposed in an annular array that is substantially concentric with the ring, a cantilevered length of each of the tissue-piercing members being sufficient to pass all the way through the side wall of the tubular graft conduit, each tissue-piercing member passing through the side wall of the tubular graft conduit from inside the lumen of the tubular graft conduit to a free end of the tissue-piercing member that is extraluminal of the tubular graft conduit, the tissue-piercing members having strength sufficient to secure the tubular graft conduit to the connector; and

(b) a plurality of hook members disposed in an annular array that is substantially concentric with the ring and that is at least partly outside the tubular graft conduit beyond the lumen of the end portion of the tubular graft conduit, portions of the hook members that are outside the tubular graft conduit beyond the lumen of the end portion of the tubular graft conduit being resiliently biased to extend, in use, radially outwardly relative to the artificially formed aperture and inside the tubular body conduit without passing through the side wall of the tubular graft conduit, the hook members having length sufficient when thus extended radially outwardly to engage the inside of the side wall of the tubular body conduit at locations annularly around the artificially formed aperture, and the hook members having strength sufficient when thus engaged with the inside of the side wall of the tubular body conduit to at least help retain the tubular graft conduit in fluid-tight, artificial connection with the tubular body conduit, the radially outwardly extending length of each of the hook members when extended radially outward being greater than the cantilevered length of each of the tissue-piercing members.

2. The assembly defined in claim 1 wherein the ring includes convolutions that repeatedly traverse a circumference of the structure.

3. The assembly defined in claim 1 wherein the hook members are additionally configured to elastically deflect substantially parallel to an axis about which the structure is annular.

4. The assembly defined in claim 1 wherein the structure is at least partly made of nitinol.

5. The assembly defined in claim 1 wherein the structure is at least partly made of stainless steel.

6. The assembly defined in claim 1 wherein the hook members initially extend substantially parallel to an axis about which the structure is annular.

7. An assembly comprising:

a tubular body tissue graft; and

a connector for use in connecting the tubular body tissue graft to the side wall of a patient'"'"'s tubular body tissue conduit so that the lumen of the graft communicates with the lumen of the conduit through an aperture in the side wall of the conduit to permit body fluid flow between the lumens without leakage of body fluid to the outside of the graft and the conduit adjacent the connector, the connector comprising;

an annular structure that forms a continuous ring and that has first and second axially adjacent portions, the first portion being disposed outside and beyond an end of the lumen of the graft but configured for disposition inside the conduit, wherein the first portion comprises a plurality of annularly spaced hook members that are resiliently biased to extend, without passing through the graft, from a first position in which the hook members are substantially parallel to an axis with which the annular structure is substantially coaxial to a second position in which the hook members are radially outward and substantially perpendicular to the axis to engage the inside of the side wall of the conduit at locations that are disposed annularly around the aperture, and the second portion being disposed inside the lumen of the graft for engaging the inside of the graft at further locations that are also disposed annularly around the graft, the second portion comprising a plurality of annularly spaced barbs configured to penetrate the tissue of the graft adjacent the further locations, each of the barbs having a length that is (1) sufficient to pass through tissue of the graft, but (2) less than a radially outwardly extending length of each of the hook members when the hook members extend radially outwardly, each of the barbs passing from inside the lumen of the graft through the tissue of the graft to a free end of the barb that is outside the graft.

8. The assembly defined in claim 7 wherein the first and second portions are configured to resiliently press the graft and the conduit into annular contact with one another annularly around the aperture.

9. The assembly defined in claim 7 wherein the structure further comprises:

a serpentine ring.

10. The assembly defined in claim 7 wherein the annular structure is at least partly made of stainless steel.

11. The assembly defined in claim 7 wherein each barb has a free end that is configured to penetrate the tissue of the graft.

12. The assembly defined in claim 11 wherein the free end of each barb is sharply pointed to facilitate penetration of the tissue of the graft by the barb.

13. The assembly defined in claim 7 wherein the first and second portions are attached to the ring at respective locations that are spaced from one another along the ring parallel to an axis about which the ring is annular.

14. The assembly defined in claim 13 wherein the plurality of hook members are spaced annularly around the ring.

15. The assembly defined in claim 14 wherein the hook members are resiliently biased to extend radially outwardly from the ring.

16. The assembly defined in claim 15 wherein the hook members are configured to elastically deflect substantially parallel to an axis with which the annular structure is substantially coaxial.

17. The assembly defined in claim 13 wherein the second portion comprises the plurality of barbs spaced annularly around the ring.

18. The assembly defined in claim 17 wherein the barbs are configured to extend radially outwardly from the ring.

19. The assembly defined in claim 7 wherein the annular structure is at least partly made of nitinol.