Medical grafting methods and apparatus

• US 20040116946A1
• Filed: 10/06/2003
• Published: 06/17/2004
• Est. Priority Date: 11/07/1996
• Status: Active Grant

• Current Assignee: St Jude Medical ATG Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical ATG Incorporated (Abbott Laboratories Incorporated)
• Inventors: Sullivan, Daniel J., Mazzocchi, Rudy, Bachinski, Thomas J., Goldsteen, David S.
• Granted Patent: US 7,578,829 B2
• Time in Patent Office: Days
• 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. A connector for use in making an artificial, fluid-tight connection between an end portion of a 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 is annularly continuous but annularly enlargeable and configured for disposition substantially concentric 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 annularly continuous structure, a cantilevered length of each of the tissue-piercing members being great enough to allow the tissue-piercing member, in use, to pass all the way through the side wall of the tubular graft conduit and to become partly extraluminal of the tubular graft conduit, the tissue-piercing members having strength sufficient to secure the tubular graft conduit to the connector when thus passed through the side wall of the tubular graft conduit; and

(b) a plurality of retention fingers disposed in an annular array that is substantially concentric with the annularly continuous structure, the retention fingers being extendable, in use, radially out relative to the artificially formed aperture and inside the tubular body conduit, the retention fingers having length sufficient when thus extended radially out to engage the inside of the side wall of the tubular body conduit at locations annularly around the artificially formed aperture, and the retention fingers 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.

2. The connector defined in claim 1 wherein the structure comprises:

a ring having convolutions that repeatedly traverse a circumference of the structure.

3. The connector defined in claim 1 wherein the retention fingers are resiliently biased to extend substantially radially out to engage the inside of the side wall of the tubular body conduit, and wherein the retention fingers are additionally configured to elastically deflect substantially parallel to an axis about which the structure is annular.

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

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

6. Apparatus for use with a connector as defined in claim 1 comprising:

a tubular structure axially reciprocable relative to the connector into and out of a position in which the tubular structure is substantially concentric outside the connector and releasably holds the retention fingers substantially parallel to an axis about which the structure is annular.

7. The connector defined in claim 1 wherein the retention fingers initially extend substantially parallel to an axis about which the structure is annular and are configured for plastic deformation to extend substantially radially outwardly to engage the inside of the side wall of the tubular body conduit.

9. The connector defined in claim 1 wherein the second substructure is configured to penetrate the tissue of the graft adjacent the further locations.

10. The connector defined in claim 1 wherein the first and second substructures are configured to resiliently press the graft and the conduit into annular contact with one another annularly around the aperture.

11. The connector defined in claim 1 wherein the structure further comprises:

an annular ring.

12. The connector defined in claim 1 wherein the second substructure comprises a plurality of annularly spaced prongs.

13. The connector defined in claim 6 wherein each prong has a free end that is configured to penetrate the tissue of the graft.

14. The connector defined in claim 7 wherein the free end of each prong is sharply pointed to facilitate penetration of the tissue of the graft by the prong.

15. The connector defined in claim 1 wherein the structure further comprises an annular ring, and wherein the first and second substructures 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.

16. The connector defined in claim 9 wherein the plurality of struts are spaced annularly around the ring.

17. The connector defined in claim 10 wherein the struts are resiliently biased to extend radially out from the ring.

18. The connector defined in claim 11 wherein the struts are configured to elastically deflect substantially parallel to an axis with which the annular structure is substantially coaxial.

19. Apparatus for use with a connector as defined in claim 12 comprising:

a tubular structure axially reciprocable relative to the connector into and out of a position in which the tubular structure is substantially concentric outside the annular structure and releasably holds the struts substantially parallel to the axis with which the annular structure is substantially coaxial in the first position.

20. The connector defined in claim 9 wherein the second substructure comprises a plurality of prongs spaced annularly around the ring.

21. The connector defined in claim 14 wherein the prongs are configured to extend radially out from the ring.

22. The connector defined in claim 1 wherein the annular structure is at least partly made of nitinol.

23. The connector defined in claim 1 wherein the annular structure is at least partly made of stainless steel.

8. A connector for use in connecting a 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 comprising:

an annular structure having first and second axially adjacent substructures, the first substructure being configured to be disposed inside the conduit, wherein the first substructure comprises a plurality of annularly spaced struts that are configured to extend from a first position in which the struts are substantially parallel to an axis with which the annular structure is substantially coaxial to a second position in which the struts are substantially radially outward to engage the inside of the side wall of the conduit at locations that are disposed annularly around the aperture, and the second substructure being configured to engage the inside of the graft at further locations that are also disposed annularly around the aperture.