Clip and deployment apparatus for tissue closure

• US 9,149,276 B2
• Filed: 03/21/2011
• Issued: 10/06/2015
• Est. Priority Date: 03/21/2011
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Voss, Laveille Kao
• Primary Examiner(s): Woo, Julian W
• Assistant Examiner(s): Templeton, Christopher L
• Application Number:
  US13/052,634
• Publication Number:
  US 20120245603A1
• Time in Patent Office: 1,660 Days
• Field of Search: 606/142, 606/143, 606/151, 606/157, 606/158, 606/140, 606/141, 606/120, 606/149, 606/215, 606/216, 606/213, 604104-109, 132/273, 132/278, 24/305.S, 24/305.R, 245/45, 600/127
• US Class Current: 1/1
• 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 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 17/128 for applying or removing clamps or clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00584 Clips
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00676 promotion of self-sealing of the puncture
• CPC Class Codes: A61B 2017/00986 Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
• CPC Class Codes: A61B 2017/081 Tissue approximator A61B2017/1103, A61B17/8866 take precedence

Abstract

A tissue engaging device and a corresponding deployment apparatus. The tissue engaging device has a generally annular-shaped body disposed about a central axis. The body has a plurality of inwardly protruding members separated by corresponding intermember spaces. The body is movable between a first position where the body is substantially convex before engagement with the tissue and a second position where the body is substantially concave when the body is engaged with the tissue. The tissue engaging device may be bioabsorbable. The deployment apparatus has a sheath and a tissue eversion apparatus for everting the tissue and positioning the everted tissue within the tissue engaging device.

Claims

1. A tissue closure device for closing an opening in a tissue having an interior surface and an opposing exterior surface, the tissue closure device comprising:

a deployment apparatus comprising;

a sheath having a central longitudinal axis extending between a proximal end and a spaced apart distal end, a lumen extending between the proximal end and the spaced apart distal end, the lumen being bounded by a lumen surface; and

a tissue eversion apparatus configured to form an everted tissue region, the tissue eversion apparatus being positioned within the lumen of the sheath and deployable therefrom for engaging the interior surface of the tissue and everting edges of the tissue; and

a tissue engaging device operatively coupled to the deployment apparatus and deliverable therefrom, the tissue engaging device comprising an annular-shaped body disposed about a central axis, the annular-shaped body having an aperture extending therethrough for receiving everted edges of the tissue and closing the opening in the tissue, the annular-shaped body being movable between a first position where the annular-shaped body is convex before engagement with the tissue, and a second position where the annular-shaped body is concave when the annular-shaped body is engaged with the tissue,

wherein the tissue eversion apparatus includes a plurality of substantially flexible members, each of the plurality of substantially flexible members having a proximal end, a distal end, and a plurality of barbs for everting the tissue and drawing the tissue upward through the aperture of the tissue engaging device such that the everted edges of the tissue extend upward through the aperture when closing the opening in the tissue, the plurality of barbs including a first barb located proximally from the distal end of each of the plurality of substantially flexible members and a second barb located proximally from the first barb, each barb being oriented perpendicular to the plurality of substantially flexible members, and

wherein a distal end of the lumen of the sheath of the deployment apparatus includes a retaining member disposed at the distal end of the lumen of the sheath, the retaining member being configured to retain the tissue engaging device in the lumen of the sheath until the tissue is drawn upward through the aperture, wherein a portion of the plurality of substantially flexible members containing the plurality of barbs is planar and perpendicular to the central longitudinal axis of the sheath in a deployed configuration.

2. The tissue closure device according to claim 1, wherein the plurality of barbs are aligned relative to one another on each of the plurality of substantially flexible members.

3. The tissue closure device according to claim 2, wherein the plurality of barbs form a first array and a second array, and wherein the first array of barbs and the second array of barbs are laterally offset from one another and are parallel to each other.

4. The tissue closure device according to claim 1, wherein the portion of the plurality of substantially flexible members containing the plurality of barbs is flat.

5. The tissue closure device according to claim 1, wherein the tissue engaging device is bioabsorbable.

6. The tissue closure device according to claim 1, wherein the tissue eversion apparatus is configured to position the everted edges of the tissue within the tissue engaging device.

7. The tissue closure device according to claim 1, wherein the tissue eversion apparatus also includes an adhesive coating for everting the tissue.

8. The tissue closure device according to claim 1, wherein the aperture of the body of the tissue engaging device is aligned with the lumen of the deployment apparatus so that the tissue eversion apparatus passes through the aperture when deployed from the lumen.

9. The tissue closure device according to claim 1, wherein the tissue eversion apparatus is movable between an unexpanded state in which the tissue eversion apparatus is configured to not contact the tissue, and an expanded state in which the tissue eversion apparatus is configured to contact and evert the tissue.

10. The tissue closure device according to claim 9, wherein the tissue eversion apparatus is configured such that the barbs contact and evert the tissue when the tissue eversion apparatus is in the expanded state.

11. The tissue closure device according to claim 10, wherein each of the plurality of substantially flexible members has an outer surface and wherein the barbs extend outwardly from the outer surface.

17. The tissue closure device according to claim 10, wherein each of the plurality of substantially flexible members has an outer surface and wherein the barbs extend outwardly from the outer surface.

12. A tissue closure device for closing an opening in a tissue having an interior surface and an opposing exterior surface, the tissue closure device comprising:

a deployment apparatus comprising;

a sheath having a central longitudinal axis extending between a proximal end and a spaced apart distal end, a lumen extending between the proximal end and the spaced apart distal end, the lumen being bounded by a lumen surface; and

a tissue eversion apparatus configured to form an everted tissue region, the tissue eversion apparatus being positioned within the lumen of the sheath and deployable therefrom for engaging the interior surface of the tissue and everting edges of the tissue; and

a tissue engaging device operatively coupled to the deployment apparatus and deliverable therefrom, the tissue engaging device comprising an annular-shaped body disposed about a central axis, the annular-shaped body having an aperture extending therethrough for receiving everted edges of the tissue and closing the opening in the tissue, the annular-shaped body having a plurality protruding members extending into the aperture and separated by corresponding intermember spaces, wherein at least one of the plurality protruding members comprises a tine and wherein at least one of the plurality protruding members comprises a tab;

the tissue eversion apparatus including a plurality of substantially flexible members, each of the plurality of substantially flexible members having a proximal end, a distal end, and a plurality of barbs for everting the tissue and drawing the tissue upward through the aperture of the tissue engaging device such that everted edges of the tissue extend upward through the aperture when closing the opening in the tissue, the plurality of barbs including a first barb located proximally from the distal end of each of the plurality of substantially flexible members and a second barb located proximally from the first barb, each barb being oriented perpendicular to the plurality of substantially flexible members,

wherein the annular-shaped body of the tissue engaging device is movable between a first position where the annular-shaped body is convex before engagement with the tissue, and a second position where the annular-shaped body is concave when the annular-shaped body is engaged with the tissue so as to draw additional tissue upward through the aperture of the tissue engaging device when closing the opening in the tissue, and

wherein a distal end of the lumen of the sheath of the deployment apparatus includes a retaining member disposed at the distal end of the lumen of the sheath, the retaining member being configured to retain the tissue engaging device in the lumen of the sheath until the tissue is drawn upward through the aperture, and

wherein a portion of the plurality of substantially flexible members containing the plurality of barbs is planar and perpendicular to the central longitudinal axis of the sheath in a deployed configuration.

13. The tissue closure device according to claim 12, wherein the tissue engaging device is bioabsorbable.

14. The tissue closure device according to claim 12, wherein the aperture of the annular-shaped body of the tissue engaging device is aligned with the lumen of the deployment apparatus so that the tissue eversion apparatus passes through the aperture when deployed from the lumen.

15. The tissue closure device according to claim 12, wherein the tissue eversion apparatus is movable between an unexpanded state in which the tissue eversion apparatus is configured to not contact the tissue, and an expanded state in which the tissue eversion apparatus is configured to contact and evert the tissue.

16. The tissue closure device according to claim 15, wherein the tissue eversion apparatus is configured such that the barbs contact and evert the tissue when the tissue eversion apparatus is in the expanded state.

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

providing a tissue closure device for closing the opening in the body tissue having an interior surface and an opposing exterior surface, the tissue closure device comprising;

a deployment apparatus comprising;

a sheath having a central longitudinal axis extending between a proximal end and a spaced apart distal end, a lumen extending between the proximal end and the spaced apart distal end, the lumen being bounded by a lumen surface; and

a tissue eversion apparatus configured to form an everted tissue region, the tissue eversion apparatus being positioned within the lumen of the sheath and deployable therefrom for engaging the interior surface of the body tissue and everting edges of the body tissue; and

a tissue engaging device operatively coupled to the deployment apparatus and deliverable therefrom, the tissue engaging device comprising an annular-shaped body disposed about a central axis, the annular-shaped body having an aperture extending therethrough for receiving everted edges of the body tissue and closing the opening in the body tissue, the annular-shaped body being movable between a first position where the annular-shaped body is convex before engagement with the body tissue and a second position where the annular-shaped body is concave when the annular-shaped body is engaged with the body tissue,

wherein the tissue eversion apparatus includes a plurality of substantially flexible members, each substantially flexible member having a proximal end, a distal end, and a plurality of barbs for everting the body tissue and drawing the body tissue upward through the aperture of the tissue engaging device such that the everted edges of the body tissue extend upward through the aperture when closing the opening in the body tissue, the plurality of barbs including a first barb located proximally from the distal end of each of the plurality of substantially flexible members and a second barb located proximally from the first barb, each barb being oriented perpendicular to the plurality of substantially flexible members, and

wherein a distal end of the lumen of the sheath of the deployment apparatus includes a retaining member disposed at the distal end of the lumen of the sheath, the retaining member being configured to retain the tissue engaging device in the lumen of the sheath until the body tissue is drawn upward through the aperture, wherein a portion of the plurality of substantially flexible members containing the plurality of barbs is planar and perpendicular to the central longitudinal axis of the sheath in a deployed configuration;

positioning the tissue engaging device over the opening in the body tissue;

forming an everted tissue region around the opening in the body tissue; and

passing the everted tissue region through the aperture in the tissue engaging device, thereby causing the tissue engaging device to become substantially concave with respect to the body tissue to secure the everted tissue region within the aperture and close the opening.

19. A method of closing an opening extending between an interior surface and an opposing exterior surface of a body tissue, the method comprising:

positioning a deployment apparatus adjacent the opposing exterior surface and over the opening in the body tissue, the deployment apparatus comprising;

a sheath having a central longitudinal axis extending between a proximal end and a spaced apart distal end, a lumen extending between the proximal end and the spaced apart distal end, the lumen being bounded by a lumen surface; and

a tissue eversion apparatus configured to form an everted tissue region, the tissue eversion apparatus being positioned within the lumen of the sheath and deployable therefrom for engaging the interior surface of the body tissue and everting edges of the body tissue; and

a tissue engaging device operatively coupled to the deployment apparatus and deliverable therefrom, the tissue engaging device comprising an annular-shaped body disposed about a central axis, the annular-shaped body having an aperture extending therethrough for receiving everted edges of the body tissue and closing the opening in the body tissue, the annular-shaped body being movable between a first position where the annular-shaped body is convex before engagement with the body tissue and a second position where the annular-shaped body is concave when the annular-shaped body is engaged with the body tissue,

wherein the tissue eversion apparatus includes a plurality of substantially flexible members, each substantially flexible member having a proximal end, a distal end, and a plurality of barbs for everting the body tissue and drawing the body tissue upward through the aperture of the tissue engaging device such that the everted edges of the body tissue extend upward through the aperture when closing the opening in the body tissue, the plurality of barbs including a first barb located proximally from the distal end of each of the plurality of substantially flexible members and a second barb located proximally from the first barb, each barb being oriented perpendicular to the plurality of substantially flexible members, and

wherein a distal end of the lumen of the sheath of the deployment apparatus includes a retaining member disposed at the distal end of the lumen of the sheath, the retaining member being configured to retain the tissue engaging device in the lumen of the sheath until the body tissue is drawn upward through the aperture, wherein a portion of the plurality of substantially flexible members containing the plurality of barbs is planar and perpendicular to the central longitudinal axis of the sheath in a deployed configuration;

deploying the tissue eversion apparatus from the sheath through the opening of the body tissue so that the tissue eversion apparatus engages the interior surface of the body tissue;

retracting the tissue eversion apparatus back into the sheath, the engagement of the tissue eversion apparatus with the interior surface of the body tissue causing an everted tissue region to be formed around the opening as the tissue eversion apparatus is retracted, the everted tissue region being passed through the aperture in the tissue engaging device as the tissue eversion apparatus is retracted, thereby causing the tissue engaging device to become substantially concave with respect to the body tissue to secure the everted tissue region within the aperture and close the opening; and

disengaging the tissue eversion apparatus from the everted tissue region, the everted tissue region remaining secured within the tissue engaging device to close the opening, and the tissue engaging device remaining substantially concave with respect to the body tissue.

20. The method according to claim 19, wherein deploying the tissue eversion apparatus comprises extending the plurality of substantially flexible members such that the barbs disposed on an outer surface of the plurality of substantially flexible members extend through the opening of the body tissue in an unexpanded state and expanding the substantially flexible members such that the tissue engaging members engage the interior surface of the body tissue.