Trocar for use in deploying an anastomosis device and method of performing anastomosis

• US 6,371,964 B1
• Filed: 11/15/1999
• Issued: 04/16/2002
• Est. Priority Date: 05/18/1999
• Status: Expired due to Term

• Current Assignee: Aesculap AG (Lonza Group AG)
• Original Assignee: Vascular Innovations Inc (B. Braun Holding GmbH & Co. KG)
• Inventors: Hendricksen, Michael, Anderson, Scott C., Donohoe, Brendan M., Vargas, Jaime, Bender, Theodore, Hausen, Bernard, Yencho, Stephen
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/440,263
• Time in Patent Office: 883 Days
• Field of Search: 606/152-155, 606/158, 606/181, 606/184
• US Class Current: 606/153
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• 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 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• 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
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11

Abstract

A trocar useful for forming an incision in a target vessel for placement of an anastomosis device which may have an inner flange formed by radial expansion of the device and an outer flange formed by axial compression of the device. The trocar can have a smaller size during formation of the incision and a larger size when retracted over a deployment tool used to deploy the anastomosis device.

Claims

1. A device for forming an incision in a wall of a target vessel and delivering an anastomosis device for connecting an end of a graft vessel to a target vessel at the site of the incision, the device comprising:

a member having a piercing element at a distal end thereof and the member being adapted to cooperate with a deployment tool such that the anastomosis device can be delivered to the incision site by the development tool and the piercing element can be withdrawn from the incision site prior to deployment of the anastomosis device, wherein the piercing element includes a cutting blade which is movable with respect to the member such that the cutting blade can be moved from a cutting position at which the cutting blade is exposed with respect to the member to a retracted position at which the cutting blade is not exposed with respect to the member.

2. The device of claim 1, wherein the piercing element comprises a sharpened inclined surface at the distal end of the member.

3. The device of claim 1, wherein the tubular member includes distal and proximal portions, the distal portion having a smaller diameter than the proximal portion, and the piercing element comprises a sharpened inclined surface being on a free end of the distal portion.

4. The device of claim 3, wherein the distal portion includes at least one axially extending tear line which allows the distal portion to be split and expanded over the deployment tool.

5. The device of claim 1, wherein the piercing element comprises a cutting blade which forms an elongated slit upon insertion of the piercing element into the vessel wall.

6. The device trocar of claim 3, wherein the piercing element comprises a tapered tip and anvil surface which forms a rounded incision upon insertion of the piercing element into the vessel wall.

7. A device for forming an incision in a wall of a target vessel and delivering an anastomosis device for connecting an end of a graft vessel to a target vessel at the site of the incision, the device comprising:

a member having a piercing element at a distal end thereof and the member being adapted to cooperate with a deployment tool such that the anastomosis device can be delivered to the incision site by the deployment tool and the piercing element can be withdrawn from the incision site prior to deployment of the anastomosis device, wherein the member comprises a tubular member having a passage therein through which the anastomosis device is delivered to the incision site, and wherein the tubular member further includes a deformable tubular wall.

8. The device of claim 7, wherein the tubular wall includes openings therein which allow the tubular member to be deformed from a smaller configuration to a larger configuration.

9. The device of claim 8, wherein the openings are defined by a plurality of axially extending wall sections and a plurality of circumferentially extending wall sections.

10. The device of claim 8, wherein the inclined surface is a continuous surface interrupted by a plurality of slits extending between the inclined surface and the openings located closest to the inclined surface.

11. The device of claim 9, wherein the openings comprise axially extending slots arranged in a staggered pattern such that the circumferentially extending wall sections intersect a pair of the slots.

12. The device of claim 7, wherein the deformable tubular wall is made from plastic or metal.

13. A device for forming an incision in a wall of a target vessel and delivering an anastomosis device for connecting an end of a graft vessel to a target vessel at the site of the incision, the device comprising:

a member having a piercing element at a distal end thereof and the member being adapted to cooperate with a deployment tool such that the anastomosis device can be delivered to the incision site by the deployment tool and the piercing element can be withdrawn from the incision site prior to deployment of the anastomosis device, wherein the piercing element includes a cutting blade which is movable with respect to the member such that the cutting blade can be moved from a cutting position at which the cutting blade is exposed with respect to the member to a retracted position at which the cutting blade is not exposed with respect to the member, wherein the piercing element includes a vessel wall piercing portion and a trimming portion, the piercing portion forming the incision upon insertion of the distal end of the member into the vessel wall and the trimming portion removing tissue around the incision upon retraction of the member.

14. The device of claim 13, wherein the member comprises a tubular member and the piercing portion comprises a plurality of axially extending tines at the distal end of the tubular member.

15. The device of claim 13, wherein the piercing portion comprises a plurality of axially extending tines and the trimming portion comprises cutting edges on outer surfaces of the tines or the piercing portion comprises a tapered tip and the trimming portion comprises an anvil surface at one end of the tapered tip.

16. The device of claim 14, wherein distal ends of the tines are biased in close proximity to each other such that the incision can be formed by advancing the tines into the vessel wall, the incision being expanded by spreading of the tines upon delivery of the anastomosis device.

17. A device for forming an incision in a wall of a target cessel and delivering an anastomosis device for connecting an end of a graft vessel to a target vessel at the site of the incision, the device comprising:

a member having a piercing element at a distal end thereof and the member being adapted to cooperate with a deployment tool such that the anastomosis device can be delivered to the incision site by the deployment tool and the piercing element can be withdrawn from the incision site prior to deployment of the anastomosis device, wherein the piercing element comprises a cutting blade which forms an elongated slit upon insertion of the piercing element into the vessel wall, and the member comprises a tubular member which includes tines at the distal end thereof, the tines being separated from each other and from the cutting blade by axially extending slits.

18. The device of claim 17, wherein distal ends of the tines are biased in close proximity to each other at a location spaced from the distal end of the cutting blade.

19. A method of performing anastomosis comprising:

using a device to form an incision in a wall of a target vessel, the device comprising;

a member having a piercing element at a distal end thereof, the member adapted to cooperate with a deployment tool such that an anastomosis device can be delivered to an incision site;

inserting the anastomosis device with the deployment tool into the incision, the anastomosis device having an end of a graft vessel everted around a first portion of the anastomosis device; and

manipulating the first portion of the anastomosis device with respect to a second portion of the anastomosis device to capture edges of the incision in the target vessel with the anastomosis device such that a fluid passage is established between the graft vessel and the target vessel.

20. The method of claim 19, wherein the target vessel is an aorta and the method is performed without clamping of the aorta.

21. The method of claim 19, wherein the end of the graft vessel and the edges of the incision in the target vessel are captured between the first portion and the second portion and the end of the graft vessel abuts an outside of the target vessel, the first portion comprising an inner flange formed by radial expansion of the anastomosis device and the second portion comprising an outer flange formed by axial compression of the anastomosis device.

22. The method of claim 19, wherein the anastomosis device is expandable from a first configuration to a larger second configuration, the method including expanding the anastomosis device with an expander to cause a portion of the anastomosis device to extend outward forming the first flange, the first flange holding a portion of the graft vessel in contact with an inner surface of the target vessel.

23. The method of claim 22, further comprising retracting the device over the anastomosis device and along the expander prior to expanding the anastomosis device with the expander, the device being deformed during the retracting step.

24. The method of claim 23, wherein the second portion of the anastomosis device is formed by axially compressing the anastomosis device with a deployment tool.

25. The method of claim 24, wherein the deployment tool comprises a tube which engages a proximal end of the anastomosis device, the compressing step being carried out by moving the expander relative to the tube.

26. The method of claim 25, wherein a groove on the expander engages the anastomosis device during formation of the second portion.

27. The method of claim 19, wherein the piercing element includes a plurality of cutting edges which form small slits around the incision or the piercing element includes a tapered tip which forms the incision and an anvil surface which enlarges and rounds the incision.

28. The method of claim 19, wherein the anastomosis device comprises an expandable linkage which is delivered through the device to the site of the incision, the linkage being deformed to an expanded size during formation of the first and second portions, the incision formed by the device being smaller than the expanded size.

29. The method of claim 19, wherein the first and second portions form an angle between about 40 and 140 degrees with an axis of the anastomosis device.