Arteriotomy closure devices and techniques

• US 7,025,776 B1
• Filed: 08/21/2002
• Issued: 04/11/2006
• Est. Priority Date: 04/24/2001
• Status: Expired due to Fees

• Current Assignee: Bioventrix, Inc.
• Original Assignee: Advanced Catheter Engineering, Inc.
• Inventors: Houser, Russell A., Hare, William D.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US10/224,659
• Time in Patent Office: 1,329 Days
• Field of Search: 606/213
• US Class Current: 606/213
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/2925 Pistol grips

Abstract

An arterial closure system includes an arterial closure device (“ACD”) and a deployment tool. The arterial closure device includes a first member forming an enlargement around the circumference of the arterial closure device and being configured to be received against an outer surface of a vessel, a connecting member having a smaller outer diameter than the first member, extending from the first member, and being configured to be positioned within an arteriotomy of a vessel, and a longitudinal channel configured to receive a tube and passing between the first member and the connecting member. The deployment tool includes a handle, a contacting section, and an extension that extends between the handle and the contacting section. The contacting section is designed to mate with the arterial closure device to advance the arterial closure device over the tube and deploy the arterial closure device within the vessel.

Claims

1. An arterial closure device deliverable over a tube for placement within and against an arteriotomy, the arterial closure device comprising:

a first member forming an enlargement around the circumference of the arterial closure device and being configured to be received against an outer surface of a vessel;

a connecting member having a smaller outer diameter than the first member, extending from the first member, and being configured to be positioned within an arteriotomy of a vessel; and

a longitudinal channel configured to receive a tube, the longitudinal channel passing between the first member and the connecting member, wherein the connecting member is expandable from a first narrow diameter to a second expanded diameter and wherein expanding the connecting member from a first narrow diameter to a second expanded diameter opens an inner diameter of the longitudinal channel that otherwise is substantially closed.

2. The arterial closure device of claim 1, wherein the connecting member comprises slits.

3. The arterial closure device of claim 1, further comprising a second member extending from the connecting member, forming an enlargement around the circumference of the arterial closure device and being configured to be received against an inner surface of the vessel when the first member is received against the outer surface of the vessel.

4. The arterial closure device of claim 3, further comprising an adhesive layer on at least one of the first member, the second member, and the connecting member.

5. The arterial closure device of claim 1, further comprising an adhesive layer on at least one of the first member and the connecting member.

6. The arterial closure device of claim 1, further comprising an adhesive within the longitudinal channel.

7. The arterial closure device of claim 1, further comprising longitudinal slots along the longitudinal channel.

8. The arterial closure device of claim 1, further comprising an extending member extending from the first member in a generally opposite direction away from the connecting member, the longitudinal channel continuing from the first member through the extending member.

9. The arterial closure device of claim 8, wherein the extending member includes a closable opening of the longitudinal channel.

10. The arterial closure device of claim 1, further comprising a slot along at least a part of the length of the arterial closure device.

11. The arterial closure device of claim 1, further comprising a deployment tool, the deployment tool including a handle, a contacting section, and an extension that extends between the handle and the contacting section, the contacting section being configured to mate with the arterial closure device to advance the arterial closure device over the tube and deploy the arterial closure device within the vessel.

12. The arterial closure device of claim 1, wherein at least one of the first member or the connecting member comprises a superelastic/shape memory component, a material that swells or expands when exposed to a fluid, a biodegradable/bioabsorbable material, a therapeutic agent configured to affect healing at the site of implantation of the ACD;

or a biocompatible material.

13. An arterial closure device deliverable over a tube for placement within and against an arteriotomy, the arterial closure device comprising:

a first member forming an enlargement around the circumference of the arterial closure device and being configured to be received against an outer surface of a vessel;

a connecting member having a smaller outer diameter than the first member, extending from the first member, and being configured to be positioned within an arteriotomy of a vessel;

a second member extending from the connecting member, forming an enlargement around the circumference of the arterial closure device and being configured to be received against an inner surface of the vessel when the first member is received against the outer surface of the vessel; and

a longitudinal channel configured to receive a tube, the longitudinal channel passing between the first member and the connecting member, wherein the first member extends at an angle from the arterial closure device, the second member extends at an angle from the arterial closure device, and the first member is generally oriented in the direction of the second member.

14. The arterial closure device of claim 13, wherein the connecting member is expandable from a first narrow diameter to a second expanded diameter and wherein expanding the connecting member from a first narrow diameter to a second expanded diameter opens an inner diameter of the longitudinal channel that otherwise is substantially closed.

15. An arterial closure system comprising an arterial closure device and a deployment tool,

the arterial closure device comprising:

a first member forming an enlargement around the circumference of the arterial closure device and being configured to be received against an outer surface of a vessel, the first member comprising at least one superelastic/shape memory element configured to move between a first extended position and a second extended position,

a connecting member having a smaller outer diameter than the first member, extending from the first member, and being configured to be positioned within an arteriotomy of a vessel,

a second member extending from the connecting member, the second member comprising at least one superelastic/shape memory element configured to move between a first extended position and a second extended position, and

a longitudinal channel configured to receive a tube, the longitudinal channel passing between the first member and the connecting member, and

the deployment tool comprising a handle, a contacting section, and an extension that extends between the handle and the contacting section, the contacting section being configured to mate with the arterial closure device to advance the arterial closure device over the tube and deploy the arterial closure device within the vessel,

wherein the arterial closure device includes a slot along at least a portion of the length of the arterial closure device and the contacting section of the deployment tool includes a longitudinal slot.

16. The arterial closure system of claim 15, wherein the second member forms an enlargement around the circumference of the arterial closure device and is configured to be received against an inner surface of the vessel when the first member is received against the outer surface of the vessel.

17. The arterial closure system of claim 15, wherein at least one of the first member or the connecting member comprises a superelastic/shape memory component, a material that swells or expands when exposed to a fluid, a biodegradable/bioabsorbable material, a therapeutic agent configured to affect healing at the site of implantation of the ACD;

or a biocompatible material.

18. A method of closing an opening in a vessel, the method comprising:

providing an arterial closure device comprising;

a first member forming an enlargement around the circumference of the arterial closure device and being configured to be received against an outer surface of a vessel,

a connecting member having a smaller outer diameter than the first member, extending from the first member, the connecting member being expandable from a first narrow diameter to a second expanded diameter and being configured to be positioned within an arteriotomy of a vessel, and

a longitudinal channel configured to receive a tube, the longitudinal channel passing between the first member and the connecting member, and

providing a deployment tool comprising a handle, a contacting section, and an extension that extends between the handle and the contacting section, the contacting section being configured to mate with the arterial closure device to advance the arterial closure device over the tube and deploy the arterial closure device within the vessel;

slidably mounting the arterial closure device to a tube;

inserting the tube through an opening into the vessel;

using the deployment tool to advance and deploy the arterial closure device by advancing the arterial closure device along the tube until the connecting member is deployed within the vessel and the first member is received against the outer surface of the vessel; and

removing the tube from the vessel and from the arterial closure device.

19. The method of claim 18, wherein the arterial closure device further comprises a second member extending from the connecting member, forming an enlargement around the circumference of the arterial closure device and being configured to be received against an inner surface of the vessel when the first member is received against the outer surface of the vessel and an adhesive layer is positioned on at least one of the first member, the second member, and the connecting member, and deploying the arterial closure device further comprises positioning the second member against the inner surface of the vessel.

20. The method of claim 18, wherein expanding the connecting member from a first narrow diameter to a second expanded diameter opens an inner diameter of the longitudinal channel that otherwise is substantially closed.

21. The method of claim 18, wherein at least one of the first member or the connecting member comprises a superelastic/shape memory component, a material that swells or expands when exposed to a fluid, a biodegradable/bioabsorbable material, a therapeutic agent configured to affect healing at the site of implantation of the ACD;

or a biocompatible material.