Vascular sheath with puncture site closure apparatus and methods of use

• US 6,197,042 B1
• Filed: 01/05/2000
• Issued: 03/06/2001
• Est. Priority Date: 01/05/2000
• Status: Expired due to Term

• Current Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Medical Technology Incorporated
• Inventors: Aldrich, William N., Ginn, Richard S.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/478,179
• Time in Patent Office: 426 Days
• Field of Search: 606/213, 606/139, 606/142, 606/144, 606/148, 606/219, 227/175.1, 227/179.1
• 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 17/083 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 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 2017/00862 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: A61M 25/0662 Guide tubes

Abstract

Apparatus and methods are provided for use in sealing a vascular puncture site. The invention comprises an introducer sheath with an integrated closure component. The closure component includes an advanceable resilient spring clip with an expanded delivery configuration in which opposing sides do not contact one another, and an unstressed deployed configuration, in which opposing sides close towards one another. The clip is advanced along the sheath until it pierces opposing sides of a vessel wall at a puncture site. The sheath then is withdrawn, thereby causing the clip to resiliently return to its unstressed deployed configuration and draw opposing sides of the puncture together to seal the wound.

Claims

1. Apparatus for sealing a puncture in a vessel wall comprising:

an introducer sheath having proximal and distal regions and an exterior surface;

a housing coaxially and slidably disposed on the exterior surface of the introducer sheath, the housing including a portion defining a chamber;

a clip resiliently expandable from an unstressed, deployed configuration wherein opposing sides of the clip are directed inwards towards one another, and an expanded, delivery configuration, in which the clip is slidably accepted within the chamber; and

an actuator for deploying the clip from the chamber into engagement with the vessel wall to close the puncture.

2. The apparatus of claim 1, wherein the actuator advances the clip from the proximal end of the sheath to the vessel wall.

3. The apparatus of claim 2, wherein the actuator comprises at least one elongated member coupled to the housing.

4. The apparatus of claim 3, wherein the at least one elongated member has a first position wherein the at least one elongated member engages the housing, and a second position wherein the at least one elongated member rotates the housing with respect to the expander to decrease an interior length of the chamber.

5. The apparatus of claim 1, wherein the clip is fabricated from a superelastic material.

6. The apparatus of claim 1, wherein the clip comprises a tubular member comprising a plurality of elongated tissue-engaging members.

7. The apparatus of claim 6 further comprising barbs attached to the tissue-engaging members.

8. The apparatus of claim 6, wherein the tubular member further comprises a plurality of elongated legs having proximal and distal ends, a plurality of upper members connecting respective proximal ends of the elongated legs, and a plurality of lower members interconnecting respective alternating distal ends of the elongated legs, wherein the plurality of tissue-engaging members project from the plurality of lower members.

9. The apparatus of claim 1, wherein the clip is bioabsorbable.

10. The apparatus of claim 1 further comprising at least one backbleed indicator port coupled to a proximal end of the introducer sheath to indicate a position of the housing relative to the puncture.

11. The apparatus of claim 10 wherein a tissue sealant may be delivered to the vessel wall in a vicinity of the puncture.

12. The apparatus of claim 1 further comprising a side port for introducing fluids into the introducer sheath.

13. A method of sealing a puncture in a vessel wall, the method comprising:

providing apparatus comprising an introducer sheath having proximal and distal regions and a lumen extending therebetween, a housing slidably and coaxially disposed on the proximal region of the introducer sheath, a resilient clip disposed within the housing in an expanded delivery configuration, and a clip actuator;

inserting the distal region of the introducer sheath through a patient'"'"'s skin into a vessel via the puncture;

performing an interventional or diagnostic procedure by advancing a device through the lumen of the introducer sheath;

upon completion of the procedure, coupling the clip actuator to the housing;

advancing the clip and housing through the skin with the clip actuator until the clip pierces the vessel wall on opposing sides of the puncture; and

withdrawing the introducer sheath, housing, and clip actuator from the puncture so that the clip returns to an unstressed deployed configuration and seals the puncture.

14. The method of claim 13 further comprising delivering a tissue sealant to the vessel wall in a vicinity of the puncture.

15. The method of claim 13 wherein the housing further comprises backbleed indicator ports coupled to the proximal region of the introducer sheath, the method further comprising advancing the clip and housing until blood from the puncture flows through the backbleed indicator ports to the proximal region of the introducer sheath.

16. The method of claim 13 wherein the introducer further comprises a hub having a bore and the clip actuator further comprises an elongated member, wherein coupling the clip actuator to the housing further comprises inserting the elongated member through the bore of the hub.

17. The method of claim 13 wherein the apparatus further comprises an expander which expands the clip to the delivery configuration, and advancing the clip and housing further comprises advancing the housing relative to the expander to deploy the clip from within the housing.

18. Apparatus for sealing a vascular puncture comprising:

an introducer sheath having proximal and distal regions, a lumen extending therebetween, and an exterior surface;

an expander having an exterior surface, the expander slidably and coaxially disposed on the exterior surface of the introducer sheath;

a housing coaxially disposed on and cammingly engaged with the expander, the housing including a portion defining a chamber;

a resilient clip having an unstressed, deployed configuration, in which the clip closes the puncture, and an expanded, delivery configuration, in which the clip slidably passes over the exterior surface of the expander; and

an actuator operably coupled to the housing for deploying the clip from the chamber.

19. The apparatus of claim 18, wherein the actuator is fixedly coupled to the housing.

20. The apparatus of claim 18, wherein the clip is fabricated from a superelastic material.

21. The apparatus of claim 18, wherein the clip comprises a tubular member including a plurality of tissue-engaging members.

22. The apparatus of claim 18, wherein the clip is bioabsorbable.

23. The apparatus of claim 18 further comprising at least on e backbleed indicator port coupled to a proximal end of the introducer sheath to indicate a position of the housing relative to the puncture.

24. The apparatus of claim 18, wherein the actuator advances the clip from the proximal end of the sheath to the puncture.