Sheath apparatus and methods for delivering a closure device

• US 8,579,932 B2
• Filed: 02/24/2004
• Issued: 11/12/2013
• Est. Priority Date: 02/21/2002
• Status: Active Grant

• Current Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories)
• Original Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories)
• Inventors: Pantages, Anthony J., Jabba, Ronald J., Ginn, Richard S.
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): YABUT, DIANE D
• Application Number:
  US10/786,444
• Publication Number:
  US 20040167570A1
• Time in Patent Office: 3,549 Days
• Field of Search: 606/213, 606/108, 606/41, 606/32, 606/191, 606/139, 606142-143, 606157-158, 606/215, 606/151, 128/898, 604/164.05
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• 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 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• 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 2017/00668 the implement being a tack or a staple
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body

Abstract

An apparatus for delivering a clip includes an introducer sheath including an outer surface extending between its proximal and distal ends. A clip is carried on the outer surface, e.g., on a carrier assembly that is slidable along the outer surface from the proximal end towards the distal end. A skin overlies the outer surface of the sheath and the carrier assembly that is separable from the outer surface as the carrier assembly is advanced from the proximal end towards the distal end of the sheath. During use, the distal end of the sheath is inserted into an opening through tissue, e.g., into a puncture communicating with a blood vessel. The carrier assembly is advanced towards the distal end of the sheath, causing the skin to separate from the outer surface of the elongate member, and the clip is deployed from the carrier to seal the opening.

Claims

1. A method for delivering a closure element to seal an opening through tissue beneath a patient'"'"'s skin, the closure element being carried by a carrier assembly slidable on an outer surface of an elongate member, the elongate member comprising a sleeve member overlying at least a portion of the outer surface between the carrier assembly and a distal end of the elongate member and at least partially overlying the carrier assembly, the elongate member being provided with a locator member slidably associated therewith, said locator member having one or more expandable positioning elements on its distal portion, the method comprising:

inserting the distal end of the elongate member through the patient'"'"'s skin and into an opening through tissue;

advancing the locator member distally from the distal end of the elongate member;

expanding said one or more positioning elements;

withdrawing said locator member until said positioning elements contact tissue;

following locating said positioning elements in contact with the tissue, advancing the carrier assembly carrying the closure element towards the distal end of the elongate member from a location distal the patient'"'"'s skin and distal the opening through tissue, the carrier assembly separating the sleeve member from the outer surface of the elongate member from a proximal end of the sleeve member toward a distal end of the sleeve member as the carrier assembly is advanced towards the distal end; and

deploying the closure element from the carrier assembly within the opening to substantially seal said opening, the closure element including one or more tines engaging the tissue and remaining within the tissue.

2. The method of claim 1, further comprising removing the elongate member from the opening.

3. The method of claim 1, wherein the sleeve member comprises a weakened region extending towards the distal end of the elongate member, the weakened region extending towards the distal end of the elongate member, the weakened region tearing as the carrier assembly is advanced towards the distal end of the elongate member.

4. The method of claim 1, wherein the sleeve member expands to a cross-section that is larger than a cross-section of the elongate member as the carrier assembly is advanced towards the distal end.

5. The method of claim 1, wherein the sleeve member is bonded to the outer surface of the elongate member by an adhesive, and wherein the adhesive has sufficient adhesive strength such that the sleeve member is peeled away from the outer surface as the carrier assembly is advanced towards the distal end.

6. The method of claim 1, wherein the sleeve member comprises an outer surface that is substantially slippery for facilitating advancement of the elongate member into the opening through tissue.

7. The method of claim 6, wherein the opening through tissue extends through one or more layers of fascia, and wherein the sleeve member facilitates advancement of the carrier assembly through the one or more layers of fascia.

8. The method of claim 1, wherein the opening through tissue communicates with a blood vessel, and wherein the deploying step comprises substantially sealing the opening from blood flow therethrough with the closure element.

9. The method of claim 1, further comprising coupling the carrier assembly to a proximal end of the elongate member.

10. The method of claim 1, wherein the sleeve member comprises a plurality of longitudinal slots, the slots opening as the carrier assembly is advanced, thereby expanding the sleeve member.

11. The method of claim 10, wherein the longitudinal slots are staggered relative to one another such that the sleeve member assumes a zigzag mesh configuration as it expands.

12. The method of claim 1, further comprising contracting said positioning elements and withdrawing said locator member.

13. The method of claim 1, wherein the distal end of the elongate member is inserted into the lumen of a blood vessel and wherein the positioning elements of the locator member are expanded within the lumen of a blood vessel.

14. The method of claim 13, wherein the step of withdrawing the locator member causes the positioning elements to come into contact with the wall of the blood vessel.

15. A method for delivering a closure element to seal an opening through tissue beneath a patient'"'"'s skin, the closure element being carried by a carrier assembly slidable on the outer surface of an elongate member, the elongate member being at least partially located within a sleeve member having a proximal end disposed proximate the carrier assembly and a distal end disposed proximate the distal end of the elongate member, the method comprising:

inserting a distal end of the elongate member, having a sleeve member located about the elongate member, through the patient'"'"'s skin and into an opening through tissue which opening is in blood flow communication with a lumen of a blood vessel;

following locating one or more positioning elements of a locator member in contact with the tissue and locating said distal end of the elongate member, advancing the carrier assembly carrying the closure element towards the distal end of the elongate member from a location distal the patient'"'"'s skin and distal the opening through tissue, the advancement of the carrier assembly causing the sleeve member to be disrupted from the proximal end of the sleeve member toward the distal end of the sleeve member to permit such advancement; and

deploying the closure element from the carrier assembly to substantially seal said opening, the closure element including one or more tines engaging the tissue and remaining within the tissue.

16. The method of claim 15, wherein said blood vessel is the femoral artery.

17. The method of claim 15, wherein the elongate member is provided with a locator member slidably associated therewith and said locator member is provided with one or more expandable positioning elements on its distal portion, comprising the steps of advancing the locator member distally from the distal end of the elongate member;

expanding the said one or more positioning elements; and

withdrawing said locator member until said positioning elements contact the wall of the blood vessel;

the step of withdrawing the locator member being performed prior to the step of deploying the closure element.

18. A method for delivering a closure element to seal an opening through tissue beneath a patient'"'"'s skin the closure element being carried by a carrier assembly slidable on the outer surface of an elongate member, the elongate member being at least partially located within a sleeve member having a proximal end disposed proximate the carrier assembly and a distal end disposed proximate a distal end of the elongate member, the method comprising:

inserting a distal end of the sleeve member through the patient'"'"'s skin and into an opening through tissue which opening is in blood flow communication with a lumen of a blood vessel;

following locating one or more positioning elements of a locator member in contact with the tissue, advancing the carrier assembly carrying the closure element towards the distal end of the elongate member from a location distal the patient'"'"'s skin and distal the opening through tissue, the advancement of the carrier assembly causing the sleeve member to be expanded from the proximal end of the sleeve member toward the distal end of the sleeve member to permit such advancement; and

deploying the closure element from the carrier assembly to substantially seal said opening, the closure element including one or more tines engaging the tissue and remaining within the tissue.

19. The method of claim 18, wherein said blood vessel is the femoral artery.

20. The method of claim 18, wherein the elongate member is provided with a locator member slidably associated therewith and said locator member is provided with one or more expandable positioning elements on its distal portion, comprising the steps of advancing the locator member distally from the distal end of the elongate member;

expanding the said one or more positioning elements; and

withdrawing said locator member until said positioning elements contact the wall of the blood vessel;

the step of withdrawing the locator member being performed prior to the step of deploying the closure element.