Apparatus and methods for delivering a closure device

• US 7,828,817 B2
• Filed: 08/04/2005
• Issued: 11/09/2010
• Est. Priority Date: 01/05/2000
• Status: Expired due to Fees

• Current Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated)
• Inventors: Belef, W. Martin, Aldrich, William N., Sagastegui, Javier, Pantages, Anthony, Carley, Michael T., Jabba, Ronald J., Salmon, Stephen M.
• Primary Examiner(s): Erezo; Darwin P
• Assistant Examiner(s): DANG, PHONG SON H
• Application Number:
  US11/198,811
• Publication Number:
  US 20050273136A1
• Time in Patent Office: 1,923 Days
• Field of Search: 606/213, 606/219, 606/232, 606/153, 606/151, 606/139, 606/142
• 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 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/128 for applying or removing clamps or clips
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• 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 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

An apparatus for delivering a clip to close an opening through tissue includes a sheath and a carrier assembly including a clip therein that is slidable on the sheath. An actuator assembly is connectable to the sheath, and telescoping actuator members extend from the handle that are connectable to the carrier assembly for advancing the carrier assembly along the sheath. An obturator on the actuator assembly includes splines that may be deployed beyond a distal end of the sheath, and expanded to a transverse expanded configuration for positioning the sheath before deploying the clip. The actuator members include cooperating detents that selectively release the actuator members as the carrier assembly reaches predetermined positions along the sheath for deploying the clip from the carrier assembly, and that collapse the splines to allow removal of the apparatus after deploying the clip.

Claims

1. A method of closing an opening in tissue, comprising:

disposing a sheath through a tissue path and into the opening;

coupling an actuator member to a proximal end of the sheath, the actuator member including a plurality of tubular members, wherein a clip including a plurality of distally oriented tissue penetrating tines is slidably disposed adjacent a distal end of one of the tubular members;

distally advancing an obturator assembly beyond a distal end of the clip;

deploying the obturator assembly to cause at least one expandable element to expand and distend at an angle from the sheath; and

delivering the clip to close the opening.

2. The method according to claim 1, wherein the method of delivering the clip comprises advancing one of the tubular members distally to deploy the clip and retracting the expandable element.

3. The method according to claim 1, wherein the obturator assembly comprises at least four expandable members.

4. The method according to claim 1, further comprising the step of moving the actuator member and sheath proximally until the expandable element contacts an inner surface of the opening to be closed before the step of delivering the clip.

5. The method according to claim 1, wherein the obturator assembly is associated with the actuator member.

6. The method according to claim 1, wherein the step of delivering a clip comprises substantially sealing the opening from blood flow with the closure element.

7. The method according to claim 3, wherein at least one of the expandable members further includes a radiopaque member.

8. The method according to claim 1, wherein the expandable member is unexpanded prior to delivering the clip.

9. The method according to claim 1, wherein the expandable member is unexpanded as the clip is delivered.

10. A method of closing an opening in a vessel with a clip, comprising:

inserting a sheath into a vessel;

performing a medical procedure;

coupling an actuator member to a proximal end of the sheath, the actuator member including a plurality of tubular members, wherein a clip including a plurality of distally oriented tissue penetrating tines is slidably disposed adjacent a distal end of one of the tubular members;

distally advancing an obturator assembly beyond a distal end of the clip; and

after distally advancing the obturator assembly beyond the distal end of the clip, delivering the clip to close the opening, the delivering including driving at least one of the tissue penetrating tines into or through a portion of the vessel to be closed.

11. The method according to claim 10, further comprising the step of deploying an obturator assembly to cause at least one expandable element to distend at an angle relative to an axis of the sheath.

12. The method according to claim 11, further comprising the step of moving the actuator member and sheath proximally until at least one of the expandable elements contacts an inner surface of the opening to be closed before the step of delivering the clip.

13. The method according to claim 12, wherein the method of delivering the clip comprises advancing one of the tubular members distally to deploy the clip from another tubular member and retracting the expandable element.

14. The method according to claim 10, wherein the step of delivering a clip comprises substantially sealing the opening from blood flow with the closure element.

15. The method according to claim 10, wherein the clip is disposed radially about an outer surface of the sheath.

16. The method according to claim 15, wherein the sheath further comprises an expandable member disposed about the clip.

17. The method according to claim 10, wherein the expandable member is unexpanded prior to delivering the clip.

18. The method according to claim 10, wherein the expandable member is unexpanded as the clip is delivered.

19. A method of closing an opening in tissue, comprising:

inserting a sheath into a vessel;

performing a medical procedure;

coupling an actuator member to a proximal end of the sheath, the actuator member including a plurality of tubular members, wherein a clip including a plurality of distally oriented tissue penetrating tines is slidably disposed adjacent a distal end of one of the tubular members;

distally advancing an obturator assembly beyond a distal end of the clip;

deploying the obturator assembly to cause at least one expandable element to distend at an angle relative to an axis of the sheath to locate the clip relative to the tissue; and

after distally advancing the obturator assembly beyond the distal end of the clip and after deploying the obturator assembly to cause at least one expandable element to distend at the angle relative to the axis of the sheath to locate the clip relative to the tissue, delivering the clip to close the opening, the delivering including sliding the clip distally so as to drive at least one of the tissue penetrating tines into or through the tissue adjacent to the opening.

20. The method according to claim 19, wherein the distended expandable element is collapsed as the clip is partially delivered.