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Devices and methods for performing a vascular anastomosis

Imported: 24 Feb '17 | Published: 13 Jan '04

Hanson S. Gifford, III, Lee R. Bolduc, Jeffrey A. Stein, Paul C. DiCesare, Peter F. Costa, William A. Holmes

USPTO - Utility Patents

Abstract

A system for performing an end-to-side vascular anastomosis, including an anastomosis device, an application instrument and methods for performing a vascular anastomosis. The system is applicable for performing an anastomosis between a vascular graft and the ascending aorta in coronary artery bypass surgery, particularly in port-access CABG surgery. A first aspect of the invention includes a vascular anastomosis staple. A first configuration has two parts: an anchor member, forming the attachment with the target vessel wall and a coupling member, forming the attachment with the bypass graft vessel. The anastomosis is completed by inserting the coupling member, with the graft vessel attached, into the anchor member. A second configuration combines the functions of the anchor member and the coupling member into a one-piece anastomosis staple. A second aspect of the invention includes an anastomotic fitting, having an inner flange over which the graft vessel is everted and an outer flange which contacts the exterior surface of the target vessel. A tailored amount of compression applied by the inner and outer flanges grips the target vessel wall and creates a leak-proof seal between the graft vessel and the target vessel. A third aspect of the invention has a flange to which the graft vessel attaches, by everting the graft vessel over the flange, and a plurality of staple-like members which attach the flange and the everted end of the graft vessel to the wall of the target vessel to form the anastomosis.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the anchor member and the coupling member of a two-piece embodiment of the anastomosis staple device of the present invention.

FIG. 2 is a perspective view of a staple applier system for applying the anastomosis staple device of FIG.

1.

FIG. 3 is a perspective view of the distal end of the staple applier system of FIG. 2 showing the stapling mechanism and the vessel punch mechanism along with the anchor member of the two-piece anastomosis staple device of FIG.

1.

FIG. 4 is a cross sectional view of the distal ends of the stapling mechanism and the vessel punch mechanism of the staple applier system of FIG. 2 along with the anchor member of the two-piece anastomosis staple device of FIG.

1.

FIGS. 5A-5G are side cross section view showing the sequence of operations for creating an end-to-side anastomosis with the two-piece anastomosis staple device of FIG.

1.

FIG. 6A is a perspective view of the graft insertion tool of the anastomosis staple applier system of FIG. 2 prepared for insertion of the bypass graft with the coupling member of the two-piece anastomosis staple device. FIGS. 6B-6C are side cross section and perspective views, respectively, of the distal end of the graft insertion tool of FIG.

6A.

FIGS. 7A-7C are perspective, bottom end, and side cross section views, respectively. showing a variation of the graft insertion tool prepared for creating a second anastomosis of the bypass graft using the two-piece anastomosis staple device of FIG.

1.

FIGS. 8A-8G are side views of various configurations of the attachment legs of the anchor member of FIG. 1 which allow for tailored amounts of tissue compression at the anastomosis site.

FIG. 9 is a perspective view of a one-piece embodiment of the anastomosis staple device of the present invention.

FIG. 10 is a cross sectional view of the one-piece anastomosis staple device of FIG. 9 being actuated to form an end-to-side anastomosis.

FIG. 11 is a cross sectional view of a one-piece anastomosis staple device with extended first segments on the staple legs.

FIG. 12 is a cross sectional view of a one-piece anastomosis staple device with secondary pivot points on the staple legs to create radial tissue compression.

FIG. 13 is a side cross sectional view of a staple applying tool for creating an end-to-side anastomosis using the one-piece anastomosis staple device of FIG.

9.

FIG. 14 is a cross sectional view of the distal end of the staple applying tool of FIG. 13 holding the one-piece anastomosis staple device of FIG. 9 with a graft vessel attached thereto.

FIG. 15A is a detail drawing of the female bayonet connector on the distal end of the anastomosis staple applying tool of FIG.

13. FIG. 15B is an end view of the male bayonet connector on the proximal end of the one-piece anastomosis staple device of FIG.

9.

FIG. 16 is a cross sectional schematic of another alternate embodiment of the one-piece anastomosis staple device being actuated to form an end-to-side anastomosis.

FIGS. 17A-17B are a perspective views of a first alternate construction of the two-piece anastomosis staple device of FIG.

1. FIG. 17C is a cross section view of the anchor member of the anastomosis staple device of FIG. 17A attached to the wall of a target vessel. FIG. 17D is a cross section view of a completed anastomosis using the device of FIGS. 17A-17B.

FIGS. 18A-18F show a second alternate construction of the two-piece anastomosis staple device of FIG.

1.

FIGS. 19A-19B shows a third alternate construction of the two-piece anastomosis staple device of FIG.

1.

FIG. 20 is a side cross section view of a fourth alternate construction of the two-piece anastomosis staple device of FIG.

1.

FIGS. 21A-21C are side partial cross section views of a first embodiment of an anastomotic fitting according to the invention.

FIGS. 22A-22C are side cross section views of an anastomosis fitting which is a variation of the embodiment of FIGS. 21A-21C. FIG. 22D is a proximal end view of the anastomosis fitting of FIG.

22C.

FIGS. 23A-23D are side cross section views of another variant of the embodiment of the anastomosis fitting of FIGS. 21A-21C and FIGS. 22A-22C.

FIGS. 24A-24B are side cross section views of a second embodiment of the anastomotic fitting of the invention having an expanding inner flange. FIGS. 24C and 24D are distal end views of the expanding inner flange in the collapsed position and the expanded position, respectively.

FIGS. 25A-25H show a second variant of the anastomotic fitting with an expanding inner flange is shown in FIGS. 24A-24D.

FIGS. 26A-26I show a third embodiment which is a one-piece anastomotic fitting with a deformable outer flange.

FIGS. 27A-27D show a second variant of the anastomotic fitting with a deformable outer flange.

FIGS. 28A-28I show a third variant of the anastomotic fitting with a deformable outer flange.

FIGS. 29A-29C show an embodiment of the anastomotic fitting having a secondary flange washer which attaches to the inner flange.

FIGS. 30A-30K show an embodiment of the anastomotic fitting combining deformable inner staple members and an outer flange.

FIGS. 31A-31F show a first embodiment of an anastomotic device combining a fastening flange with a plurality of staple members.

FIGS. 32A-32F show an anastomosis device using preformed spring-like fastening staple members.

FIGS. 33A-33D show an anastomosis device using S-shaped staple members that pierce the interior wall of the target vessel.

FIGS. 34A-34D show an anastomosis device using S-shaped staple members that do not pierce the interior wall of the target vessel.

FIGS. 35A-35F show an anastomosis device using U-shaped staple members with barbed points.

FIGS. 36A-36C show an anastomosis device using U-shaped staple members and a locking collar.

FIGS. 37A-37C show a second anastomosis device using U-shaped staple members and a locking collar.

FIGS. 38A-38C show a one-piece anastomosis device with integral staple members.

FIGS. 39A-39C show a second one-piece anastomosis device with integral staple members.

FIGS. 40A-40D show a two-piece anastomosis device having two concentric ring flanges with integral staple members.

FIGS. 41A-41E show an anastomosis device having a fastening flange and a plurality of individual staple members.

FIGS. 42A-42D illustrate a one-piece embodiment of the anastomosis device with a fastening flange and attached staple members.

FIGS. 43A-43B show the fastening flange of an anastomosis device using preformed superelastic alloy staple members in a top view and a side view, respectively.

FIGS. 44A-44B show the superelastic alloy staple members of the anastomosis device in a front view and a side view, respectively.

FIGS. 45A-45E show the sequence of operations of an application instrument for the anastomosis device of FIGS. 43A-43B and FIGS. 44A-44B.

FIGS. 46A-46D illustrate a second embodiment of the anastomosis system using an anastomosis device with an inner fastening flange, an outer flange and staple members made of a superelastic alloy.

FIGS. 47A-47B show an anastomosis staple device combining a fastening flange with precurved inner staple members of a highly resilient material and deformable outer attachment legs in an undeployed state.

FIGS. 48A-48B show the anastomosis staple device of FIGS. 47A-47B in a deployed state.

FIGS. 49A-49C show the sequence of operations for deploying the anastomosis staple device of FIGS. 47A-47B.

FIGS. 50A-50B show a staple application instrument for applying the anastomosis staple devices of FIGS. 47A-47B.

FIG. 51 shows a combination strain relief and compliance mismatch transition sleeve for use with any of the anastomosis devices of the present invention.

FIG. 52 shows a dual-balloon perfusion endoaortic clamp catheter for isolating a portion of the aortic wall while performing a proximal anastomosis in CABG surgery.

FIG. 53 shows a dual-balloon coronary isolation and perfusion catheter for use in performing a distal anastomosis in CABG surgery.

FIG. 54 shows a T-shaped dual-balloon coronary isolation and perfusion catheter for use in performing a distal anastomosis in CABG surgery.

FIGS. 55,

56,

57 show the sequence of operations for creating an end-to-side anastomosis during port-access CABG surgery using the anastomosis stapling system of the present invention.

Claims

1. A method for securing a graft to a target vessel, comprising:

2. The method of claim 1, wherein the securing step comprises securing at least a portion of the anastomotic device within the hole in the target vessel wall.

3. The method of claim 1, wherein the securing step comprises securing at least a portion of the anastomotic device within the target vessel.

4. The method of claim 1, wherein the securing step is performed prior to the actuating step.

5. The method of claim 1, wherein the actuating step comprises capturing the tissue excised by the punch within the punch.

6. The method of claim 5, wherein the actuating step comprises approximating a cutter and an anvil until the vessel wall tissue is captured therebetween.

7. The method of claim 1, wherein the step of advancing at least a portion of the punch comprises advancing an anvil of a punch through at least a portion of the lumen of the instrument and through the incision.

8. The method of claim 7, comprising the step of retracting the anvil of the punch from the hole.

9. The method of claim 1, comprising the step of retracting the punch through at least a portion of the lumen of the instrument.

10. The method of claim 9, wherein the retracting step comprises withdrawing the punch from the lumen of the instrument.

11. The method of claim 1, comprising the step of everting the graft vessel over a portion of the anastomotic device.

12. The method of claim 11, wherein the everting step is performed prior to the advancing step.

13. The method of claim 11, wherein the everting step comprises:

14. The method of claim 1, wherein the anastomotic device has an orifice sized to accommodate the external diameter of the graft.

15. The method of claim 1, wherein the anastomotic device has a cylindrical shape.