Integrated vascular device with puncture site closure component and sealant

• US 8,956,388 B2
• Filed: 04/21/2008
• Issued: 02/17/2015
• Est. Priority Date: 01/05/2000
• Status: Expired due to Fees

• Current Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories)
• Original Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories)
• Inventors: Ginn, Richard S., Belef, W. Martin
• Primary Examiner(s): Dornbusch, Dianne
• Assistant Examiner(s): ORKIN, ALEXANDER J
• Application Number:
  US12/106,928
• Publication Number:
  US 20080210737A1
• Time in Patent Office: 2,493 Days
• Field of Search: 606/139, 606/142, 606/213, 606/157, 606/219, 606/143, 606144-148, 606/215, 606/216, 227/175.1
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• 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 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• 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
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

Apparatus are provided for use in sealing a vascular puncture site. The invention comprises an integrated vascular device having a sheath with a closure component and puncture sealant. The closure component is disposed on and advanceable over the exterior of the sheath and may comprise any of a variety of apparatus suited for closing a vascular puncture. Once the closure component has been actuated to close the puncture, sealant is introduced to seal the puncture. The sheath and closure component are then removed from the patient.

Claims

1. A device for closing an opening in tissue, comprising:

an elongate tubular member having first and second ends and having a lumen extending therethrough;

a first jaw associated with the second end of the elongate tubular member;

a second jaw pivotally associated with the tubular member and disposed adjacent to the second end of the elongate tubular member and the first jaw;

a locator configured to locate and provide confirmation of the location of a vascular puncture;

a closure component having a plurality of tines, the closure component slidably disposed with respect to the elongate tubular member and configured to rotate to close the opening;

a clip configured to pierce and advance into tissue surrounding the opening in tissue, the clip being directly biased against the first and second jaws, with tines of the clip extending distally beyond distal ends of the first and second jaws, within a channel formed by adjacently positioned recessed portions formed in inwardly facing faces of the first and second jaws as the second jaw is biased against the first jaw to maintain the second jaw in a second, closed position and in contact with the first jaw; and

a plunger having a proximal end and a distal end, wherein the plunger is disposed within the lumen of the tubular member, wherein the distal end of the plunger is associated with the second jaw.

2. The device of claim 1, the clip having a plurality of sharp tines.

3. The device of claim 2, wherein the second jaw is movable between a first position and the second, closed position, the second jaw being retained in said second, closed position by a biasing member.

4. The device of claim 3, wherein the clip is biased against the first and second jaws when the second jaw is in the second position.

5. The device of claim 2, wherein the plunger is movable between a first position and the second, closed position, wherein when disposed in the second, closed position, the plunger moves the second jaw from said second position to said first position.

6. The device of claim 2, wherein the clip is oriented such that the tines extend longitudinally away from the elongate tubular member.

7. The device of claim 1, wherein the clip is bioabsorbable.

8. The device of claim 1, wherein the first jaw extends from the second end of the elongate tubular member, the first jaw and the elongate tubular member being integrally formed of a unitary construction.

9. A device for closing an opening in tissue, comprising:

an elongate tubular member having a first end, a second end, and a lumen extending from the first end toward the second end;

a first jaw formed by the second end of the elongate tubular member;

a second jaw pivotally mounted to the tubular member and movable relative to the first jaw;

a locator configured to locate and provide visual confirmation of the location of the first and second jaws relative to a vascular puncture, the locator including at least one backbleed port;

a distally positioned biasing member extending within the lumen of the elongate tubular member from an elongate lateral wall of the elongate tubular member directly to the second jaw, the biasing member directly applying a biasing force to the second jaw to maintain the second jaw in a closed position;

a closure component having a plurality of tines, the closure component slidably disposed with respect to the elongate tubular member and configured to rotate to close the opening;

a clip configured to pierce and advance into tissue surrounding the opening in tissue, the clip being directly biased against the first and second jaws, with tines of the clip extending distally beyond distal ends of the first and second jaws, within a channel formed by adjacently positioned recessed portions formed in inwardly facing faces of the first and second jaws in the closed position, an intermediate portion of a base of the clip being received within the channel, with sides of the base being free from engagement with the channel; and

a plunger having a proximal end and a distal end, the plunger being slidably received within the lumen and selectively engaging the second jaw to move the second jaw relative to the first jaw.

10. The device of claim 9, wherein the second jaw comprises a moment arm movable as the plunger moves within the lumen.

11. The device of claim 9, wherein the second jaw is moveable between an open position and the closed position.

12. The device of claim 11, wherein the plunger is movable between a first position and a second position, wherein when disposed in the second position the plunger moves the second jaw from the closed position to the open position.

13. The device of claim 9, wherein the clip is bioabsorbable.

14. The device of claim 9, wherein the clip is implantable.

15. The device of claim 9, the clip having a plurality of sharp tines.

16. The device of claim 9, wherein the first jaw extends from the second end of the elongate tubular member, the first jaw and the elongate tubular member being integrally formed of a unitary construction.

17. A device for closing an opening in tissue, comprising:

an elongate tubular member having first and second ends and having a lumen extending therethrough;

a first jaw associated with the second end of the elongate tubular member;

a second jaw pivotally associated with the tubular member and disposed adjacent to the first jaw;

a distally positioned spring disposed at the second end of the lumen and extending within the lumen from a lateral elongate wall of the elongate tubular member directly to the second jaw, the spring applying a biasing force to the second jaw to maintain the second jaw in a closed position relative to the first jaw;

a locator configured to locate and provide visual confirmation of the location of the first and second jaws relative to a vascular puncture, the locator including at least one backbleed port;

a closure component having a plurality of tines, the closure component slidably disposed with respect to the elongate tubular member and configured to rotate to close the opening;

a clip having a plurality of sharp tines configured to pierce and advance into tissue surrounding the vascular puncture, the locator configured to provide visual indication that the clip is properly positioned, the clip being directly biased against the first and second jaws, with sharp tines extending distally beyond distal ends of the first and second jaws, within a channel formed by adjacently positioned recessed portions formed in inwardly facing faces of the first and second jaws in the closed position, an intermediate portion of a base of the clip from which the sharp tines extend being received within the channel, with sides of the base, adjacent the intermediate portion, being free from engagement with the channel; and

a plunger movable within the lumen of the elongate tubular member, the plunger having a proximal end and a distal end comprising a release arm, the release arm selectively engaging the second jaw as the plunger selectively moves within the lumen.

18. The device of claim 17, wherein the clip is either bioabsorbable or implantable.

19. The device of claim 17, wherein the plunger is movable between a first position and a second position, wherein when disposed in the second position the plunger moves the second jaw from the closed position to an open position to release the clip.

20. The device of claim 17, wherein the second jaw is biased to remain in the closed position by a means for biasing.

21. The device of claim 17, wherein the clip is oriented such that the tines extend longitudinally away from the elongate tubular member.

22. The device of claim 17, wherein the first jaw extends from the second end of the elongate tubular member, the first jaw and the elongate tubular member being integrally formed of a unitary construction.