System and method for percutaneous coronary artery bypass

• US 6,026,814 A
• Filed: 03/06/1997
• Issued: 02/22/2000
• Est. Priority Date: 03/06/1997
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: LaFontaine, Daniel M., Wang, Lixiao, Hastings, Roger N., Harrison, Kent D., Euteneuer, Charles L.
• Primary Examiner(s): Yu, Mickey
• Assistant Examiner(s): CAMPEN, KELLY SCAGGS
• Application Number:
  US08/813,038
• Time in Patent Office: 1,083 Days
• Field of Search: 623/1, 623/12, 623/66, 623/3, 128/898, 606/192, 606/198, 606/194, 606/200, 606/191, 606/195, 606/27, 606/78, 600/300, 604/96, 604/7, 604/8, 604/9, 604/104, 604/281, 607/130
• US Class Current: 128/898
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2090/3929 Active markers
• CPC Class Codes: A61B 2090/3945 Active visible markers, e.g. light emitting diodes
• CPC Class Codes: A61B 2090/3958 emitting a signal
• 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 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: Y10S 623/902 Method of implanting

Abstract

A percutaneous system for bypassing a restriction in a native vessel of a mammal having an aorta includes providing a graft having a body portion with a first end, a second end and a lumen therebetween. An aperture is formed in the aorta. The graft is inserted into the aorta and the first end of the graft is connected to the aorta about the aperture in the aorta. An aperture is then formed in the native vessel distal of the restriction. The second end of the graft is connected to the native vessel about the aperture therein such that the lumen in the graft communicates with the aorta and the native vessel.

Claims

1. A method of percutaneously bypassing a restriction in an artery of a mammal having an aorta, the artery having an artery wall defining an artery lumen and the aorta having an aorta wall defining an aorta lumen, the method comprising:

providing a graft defining a graft lumen and having a body portion with a first end and a second end;

forming an aperture in the aorta wall;

inserting the graft into the aorta lumen;

connecting the first end of the graft to the aorta wall about the aperture in the aorta wall;

advancing the body portion of the graft through the aperture in the aorta wall after connecting the first end of the graft to the aorta wall;

forming an aperture in the artery wall distal of the restriction; and

connecting the second end of the graft to the artery wall about the aperture therein such that the graft lumen communicates with the aorta lumen and the artery lumen.

2. The method of claim 1 wherein the graft includes a normal inner graft lumen wall which constitutes the inner lumen wall of the graft when the graft is in its normal, non-inverted, configuration and a normal outer wall which constitutes the outer wall of the graft when the graft is in its normal, non-inverted, configuration, and wherein inserting the graft into the aorta lumen comprises:

inserting the graft into the aorta lumen in an inverted position such that the normal inner graft lumen wall forms the outer wall of the graft and the normal outer wall forms the inner lumen wall of the graft;

and wherein advancing the body portion of the graft through the aperture in the aorta wall comprises;

advancing the graft through the aperture in the aorta wall such that the graft becomes non-inverted.

3. The method of claim 1 wherein the aorta wall comprises an inner aorta wall and an outer aorta wall, and wherein forming an aperture in the aorta wall comprises:

isolating a region of the inner aorta wall from blood flow while allowing blood flow through the remainder of the aorta lumen; and

forming the aperture in the isolated region.

4. The method of claim 3 wherein isolating a region of the inner aorta wall comprises:

positioning a distal end of a catheter such that the distal end of the catheter encompasses the region of the inner aorta wall to be isolated; and

drawing a vacuum through the catheter causing the distal end of the catheter to abut against the region of the inner aorta wall to be isolated.

5. The method of claim 1 wherein forming an aperture in the artery wall comprises:

advancing a cutting device through the artery lumen across the restriction to a region distal of the restriction; and

cutting the aperture in the artery wall with the cutting device.

6. The method of claim 1 wherein connecting the second end of the graft to the artery wall comprises:

advancing a suturing catheter through the aorta lumen and through the graft lumen; and

suturing the second end of the graft to the artery wall with the suturing catheter.

7. The method of claim 1 wherein the graft provided in the providing step includes a coupler connected to the first end of the body portion, the coupler having a lumen running therethrough, an insertion end and a shoulder portion of greater width than the insertion end, the lumen in the coupler communicating with the lumen in the body portion, and wherein connecting the first end of the graft to the aorta wall comprises:

inserting the insertion end of the coupler into the aperture in the aorta wall such that the shoulder portion abuts an inner surface of the aorta wall proximate the aperture in the aorta wall.

8. The method of claim 7 wherein advancing the body portion of the graft through the aperture in the aorta wall comprises:

advancing the body portion of the graft through the lumen of the coupler.

9. The method of claim 1 and further comprising:

before connecting the second end of the graft to the artery wall, positioning the second end of the graft proximate a region of the artery distal of the restriction.

10. The method of claim 9 wherein positioning the second end of the graft comprises:

placing an emitter in one of the artery lumen distal of the restriction and the second end of the graft, the emitter emitting location signals;

placing a sensor in another of the artery lumen distal of the restriction and the second end of the graft, the sensor sensing the location signals and providing an output indicative of the location signals sensed; and

moving the second end of the graft based on the output from the sensor.

11. The method of claim 10 wherein placing an emitter comprises:

placing a radio frequency (RF) signal emitter in one of the artery lumen distal of the restriction and the second end of the graft; and

wherein placing a sensor comprises placing an RF sensor in another of the artery lumen distal of the restriction and the second end of the graft, the RF sensor sensing RF signals emitted by the RF signal emitter and providing the output indicative of the RF signals sensed.

12. A method of percutaneously bypassing a restriction in an artery of a mammal having an aorta, the artery having an artery wall defining an artery lumen and the aorta having an aorta wall defining an aorta lumen and comprising an inner aorta wall and an outer aorta wall, the method comprising:

providing a graft defining a graft lumen and having a body portion with a first end and a second end;

isolating a region of the inner aorta wall from blood flow while allowing blood flow through the remainder of the aorta lumen;

forming an aperture in the isolated region of the aorta wall;

inserting the graft into the aorta lumen;

connecting the first end of the graft to the aorta wall about the aperture in the aorta wall;

advancing the body portion of the graft through the aperture in the aorta wall;

forming an aperture in the artery wall distal of the restriction; and

connecting the second end of the graft to the artery wall about the aperture therein such that the graft lumen communicates with the aorta lumen and the artery lumen.

13. The method of claim 12 wherein isolating a region of the inner aorta wall comprises:

positioning a distal end of a catheter such that the distal end of the catheter encompasses the region of the inner aorta wall to be isolated; and

drawing a vacuum through the catheter causing the distal end of the catheter to abut against the region of the inner aorta wall to be isolated.

14. The method of claim 13 wherein forming an aperture in the artery wall comprises:

advancing a cutting device through the artery lumen across the restriction to a region distal of the restriction; and

cutting the aperture in the artery wall with the cutting device.

15. The method of claim 13 wherein connecting the second end of the graft to the artery wall comprises:

advancing a suturing catheter through the aorta lumen and through the graft lumen; and

suturing the second end of the graft to the artery wall with the suturing catheter.

16. A method of percutaneously bypassing a restriction in an artery of a mammal having an aorta, the artery having an artery wall defining an artery lumen and the aorta having an aorta wall defining an aorta lumen and comprising an inner aorta wall and an outer aorta wall, the method comprising:

providing a graft defining a graft lumen, the graft having a body portion with a first end and a second end and having a coupler connected to the first end of the body portion, the coupler having a lumen running therethrough, an insertion end and a shoulder portion of greater width than the insertion end, the lumen in the coupler communicating with the lumen in the body portion;

forming an aperture in the aorta wall;

inserting the graft into the aorta lumen;

inserting the insertion end of the coupler into the aperture in the aorta wall such that the shoulder portion abuts an inner surface of the aorta wall proximate the aperture in the aorta wall;

advancing the body portion of the graft through the aperture in the aorta wall;

forming an aperture in the artery wall distal of the restriction; and

connecting the second end of the graft to the artery wall about the aperture therein such that the graft lumen communicates with the aorta lumen and the artery lumen.

17. The method of claim 16 wherein advancing the body portion of the graft through the aperture in the aorta wall comprises:

advancing the body portion of the graft through the lumen of the coupler.

18. The method of claim 17 wherein the graft includes a normal inner graft lumen wall which constitutes the inner lumen wall of the graft when the graft is in its normal, non-inverted, configuration and a normal outer wall which constitutes the outer wall of the graft when the graft is in its normal, non-inverted, configuration, and wherein inserting the graft into the aorta lumen comprises:

inserting the graft into the aorta lumen in an inverted position, such that the normal inner graft lumen wall forms the outer wall of the graft and the normal outer wall forms the inner lumen wall of the graft;

and wherein advancing the body portion of the graft through the lumen in the coupler comprises;

advancing the graft through the lumen in the coupler, after inserting the insertion end of the coupler into the aperture in the aorta wall, such that the graft becomes non-inverted.

19. The method of claim 18 wherein forming an aperture in the artery wall comprises:

advancing a cutting device through the artery lumen across the restriction to a region distal of the restriction; and

cutting the aperture in the artery wall with the cutting device.

20. The method of claim 18 wherein connecting the second end of the graft to the artery wall comprises:

advancing a suturing catheter through the aorta lumen and through the graft lumen; and

suturing the second end of the graft to the artery wall with the suturing catheter.