Temporary vascular seal for anastomosis

• US 6,395,015 B1
• Filed: 03/22/2000
• Issued: 05/28/2002
• Est. Priority Date: 07/31/1997
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Heikens, Martijn, Van Dalen, Robert, Grundeman, Paul Frederik, Heijmen, Robin Henricus, Mansvelt Beck, Henricus Jacobus, Scheltes, Jules, Verlaan, Cornelius Wilhelmus Josef, Borst, Cornelius
• Primary Examiner(s): Reip, David O.
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US09/463,746
• Time in Patent Office: 797 Days
• Field of Search: 606/151,153,157,158,194,213,215,232 604/96.01,102.07
• US Class Current: 606/213
• 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 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• 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

Abstract

A temporary intravascular arteriotomy seal for insertion into and retrieval from a blood vessel through an opening in the wall of the vessel. The seal comprises a thin flexible sheet material. According to one embodiment, in an untensioned state, the seal is curved and foldable in the width direction. It is adapted to be folded in the width direction upon exertion for a force on the gripping element directed in the length direction, and upon contacting of the sheet material by the sides of the opening in the vessel wall. By use of the sealing device, arterial by-pass grafting in a briefly-occlusive or non-occlusive end-to-side or side-to-side anastomosis technique is possible with virtually no obstruction to flow, little endothelial denudation and otherwise no wall damage by the intravascular device, and without blocking of side branches. A further embodiment of a device according to the present invention is characterized in that the gripping element is formed by a supply duct which ends in an opening in the flexible sheet material for administration of substances to the supply duct into a blood vessel for rescue arterial perfusion purposes. Optionally, the seal may be inflatable.

Claims

1. Medical device (1,19,26′

) for insertion into a blood vessel through an opening in a wall of said vessel, the device comprising;

an elongated flexible sheet material (2,32) having a length dimension (L) and a width dimension (W), the sheet material (2,32) being foldable in the width direction for placing the sheet material into an insertion configuration and the sheet material being unfoldable to assume a sealing configuration inside the blood vessel for contacting the blood vessel wall in a sealing manner, the sheet material in the sealing configuration extending along an open contour, conforming to and partly covering an interior surface of the blood vessel wall;

a gripping element (3,31) on an outer surface of said sheet material;

wherein the flexible sheet material (2,32) in an untensioned state is curled in the width direction, wherein the sheet material folds in the width direction (W) upon exertion of a pulling force on the gripping element (3,31), directed generally in the length direction, and upon contacting of the sheet material by the sides of the opening in the vessel wall after partially closing the opening.

2. Medical device (1) according to claim 1, wherein the gripping element (3) is placed offset from the midpoint of the length dimension (L) at a predetermined angle (α

) with respect to the outer surface of the flexible sheet material (2), the gripping element (3) being inclined towards a shorter part of the length dimension (L).

3. Medical device (19) according to claim 1, wherein the flexible sheet material comprises an inflatable body (22,23,26) and a supply duct (24) for supply of a fluid into the inflatable body (22,23,26).

5. Medical device (26′

) according to claim 1, wherein the gripping element (31) is formed by a supply duct which ends in an opening (27) in the flexible sheet material (32) for administration of substances through the supply duct into a blood vessel.

6. Medical device (1,19,26′

) according to claim 1, wherein the flexible sheet material (2,32) is thinner near a perimeter of the flexible sheet material than near a center of the sheet material.

7. Medical device (1,19,26′

) according to claim 1, wherein the gripping element comprises an upstanding ridge (3′

).

8. Medical device (1,9,26′

) according to claim 1, further comprising orientation markings on the outer surface.

9. Medical device (1,19,26′

) according to claim 1, wherein a stiffness of the flexible sheet material (2,32) in a length direction is larger than a stiffness in a width direction.

10. Medical device (1,19,26′

) according to claim 1, wherein the flexible sheet material is non biodegradable.

11. Medical device according to claim 1, comprising a suture wire (43,48) connected to a forward part (44,51) of the sheet material.

12. Medical device according to claim 11, wherein a needle (46) is connected to the suture wire.

13. Medical device according to claim 11, wherein the suture wire (48) extends from a forward part (51) to a rearward part (52) of the sheet material along a lower side (49) thereof, and penetrates the sheet material at the rearward part (52) to continue at an upper side thereof (55).

14. Medical device according to claim 13, wherein the suture wire (48) is adhesively connected to the lower side (49).

15. Medical device according to claim 13, wherein a blocking and gripping device (53) is connected to an end of the suture wire (55) at the rearward part (52) of the sheet material.

16. Medical device according to claim 1, wherein the sheet material is at its upper surface (57) at or near its perimeter provided with an easily deformable sealing material (56).

17. Medical device according to claim 1, wherein the gripping element (72) comprises engagement means (80, 81) for engaging with a gripper device (78,79).

18. Medical device according to claim 17, wherein the engagement means comprise a bulbous part (81) on the gripping element (72).

19. Medical device according to claim 17, wherein the engagement means comprise a hook or an eye (80) on the end of the gripping element (72).

20. Assembly comprising a medical device according to claim 1 and an introducer (60), wherein the introducer (60) comprises a generally cylindrical receptor (63) having a tapering wall extension (64) for locking into an arteriotomy.

21. Assembly comprising a medical device according to claim 1 and an introducer, wherein the introducer comprises a tube (71) and a gripper device (75) displaceable in the length direction of the tube, the gripper device having a gripper head (76) which is adapted to engage with the gripping element (72) of the medical device (70).

22. Assembly according to claim 21, wherein the gripper head (76) has two flexible parts defining a slit therebetween, the flexible parts, upon retracting the gripper head within the tube, engaging with a wall of the tube such that the slit is narrowed.

23. Assembly according to claim 21, wherein the gripper head comprises a hook element (78).

4. Medical device (19) according to claim

wherein the flexible sheet material comprises two membranes (22,23) that are sealingly connected along their perimeter (25) and a supply duct (24) for supply of a fluid into the space between the membranes (22,23).

24. A temporary seal for an opening in a blood vessel, comprising:

a sheet of flexible material that has a generally oval peripheral edge with a length greater than a width, said sheet having lateral sides that curl towards one another so that said sheet is part of a cylinder in an untensioned state,

a convex outer surface of said sheet being structured and arranged to conform to an interior surface of a blood vessel completely around a periphery of an opening in the blood vessel when the temporary seal is inserted through the opening; and

a gripping element attached to said convex outer surface and that is structured and arranged to withdraw said sheet from the blood vessel when said gripping element is pulled away from the opening.

25. The seal of claim 24, wherein said gripping element is L-shaped and comprises a vertical arm whose height is greater than its length and a horizontal ridge whose height is less than its length, said horizontal ridge being joined to said vertical arm.

26. The seal of claim 24, wherein said lateral sides of said sheet touch each other in the untensioned stated.

27. The seal of claim 25, wherein said sheet is hollow and uncurls when tensioned by inflation.

28. The seal of claim 27, wherein one said lateral side of said sheet is more compliant than the other said lateral side of said sheet.

29. The seal of claim 24, wherein said sheet comprises two separate hollow portions on opposite said lateral sides that are separately inflatable, and an opening through said sheet between said hollow portions.

30. The seal of claim 24, further comprising an inflatable donut completely around a periphery of said convex outer surface of said sheet and that conforms to the interior surface of a blood vessel completely around the periphery of the opening.