Integrated vascular device with puncture site closure component and sealant and methods of use

• US 9,050,087 B2
• Filed: 05/14/2008
• Issued: 06/09/2015
• 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: Ginn, Richard S., Belef, W. Martin
• Primary Examiner(s): Anderson, Gregory
• Assistant Examiner(s): LAUER, CHRISTINA C
• Application Number:
  US12/106,937
• Publication Number:
  US 20080221616A1
• Time in Patent Office: 2,582 Days
• Field of Search: 606/213, 623 1311- 1315, 623/14.12
• US Class Current: 1/1
• 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 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 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 method of closing an opening in tissue, comprising:

disposing a sheath within a tissue tract, wherein a distal end of the sheath is disposed within an opening formed in tissue;

performing a medical procedure through a lumen of the sheath;

distally advancing at least two sharpened tips of a closure component to penetrate the tissue adjacent the opening from a proximal side toward a distal side of the tissue, the at least two sharpened tips having an expanded delivery configuration and a retracted deployed configuration to close the opening, the sharpened tips being associated with elastically deformed prongs;

moving a distal end of a member within the closure component proximally past a distal end of the at least two sharpened tips to enable the elastically deformed prongs to resiliently contract towards each other to the retracted deployed configuration to close the opening; and

applying a sealing means to the opening to effect closure of the opening.

2. The method according to claim 1, wherein the step of applying a sealing means comprises applying a sealing means selected from a group consisting of RF energy, thermal energy, electrical induction, infrared light, ultrasonic vibration, microwave or laser irradiation, clips, sutures, or adhesives.

3. The method according to claim 1, further comprising the step of delivering a sealant to the opening.

4. The method according to claim 1, further comprising the step of disposing a clip adjacent the opening to further seal the opening closed.

5. The method according to claim 1, wherein the closing step further comprises rotating the closure component after engaging the sharpened tips with the tissue.

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

disposing a sheath within a tissue tract, wherein a distal end of the sheath is disposed within an opening formed in tissue;

performing a medical procedure through a lumen of the sheath;

distally advancing at least two sharpened tips of a distally-oriented closure component along a side of the sheath to penetrate the tissue, adjacent to the opening and proximal the distal end of the sheath from a proximal side to a distal side of the tissue, to close the opening, the at least two sharpened tips having an expanded delivery configuration and a retracted deployed configuration, the sharpened tips being associated with elastically deformed prongs;

closing the opening formed in the tissue by moving a distal end of a member within the closure component proximally from a location distal the at least two sharpened tips past a distal end of the at least two sharpened tips to enable the elastically deformed prongs to resiliently contract towards each other to the retracted deployed configuration to close the opening; and

applying a sealing means to the opening to effect closure of the opening.

7. The method according to claim 6, wherein distally advancing the closure component comprises sliding the closure component along the sheath until the at least two sharpened tips engage with tissue.

8. The method according to claim 6, wherein closing the opening comprises rotating the closure component about a longitudinal axis of the closure component after engaging the at least two sharpened tips with the tissue.

9. The method according to claim 6, further comprising the act of disposing a clip adjacent the opening to further seal the opening closed.

10. The method according to claim 6, further comprising the act of delivering a sealant to the opening.

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

disposing a sheath within a tissue tract, the sheath comprising a proximal end, a distal end disposable within an opening formed in tissue, and a lumen extending from the proximal end toward the distal end;

performing a medical procedure through the lumen of the sheath;

distally advancing at least two sharpened tips of a distally-oriented closure component to penetrate the tissue adjacent to the opening, the at least two distally-oriented sharpened tips being advanced along a side of the sheath towards the distal end and being configured for engagement with tissue proximal the distal end of the sheath from a proximal side towards a distal side of the tissue, the distally-oriented sharpened tips having an expanded delivery configuration and a retracted deployed configuration;

moving a distal end of a member within the distally-oriented closure component proximally from a location distal the at least two sharpened tips past a distal end of the at least two sharpened tips to move the at least two distally-oriented sharpened tips towards one another to the retracted deployed configuration to close the opening;

wherein the at least two distally-oriented sharpened tips are associated with distally-oriented elastically deformed needles, and wherein moving the member releases the distally-oriented elastically deformed needles and moves the at least two distally-oriented sharpened tips towards one another to the retracted deployed configuration to close the opening; and

applying a sealing means to the opening to effect closure of the opening.

12. The method according to claim 11, further comprising delivering a sealant to the opening.

13. The method according to claim 11, wherein closing the opening comprises rotating the closure component about a longitudinal axis of the closure component after engaging the at least two distally-oriented sharpened tips with the tissue.

14. The method according to claim 11, further comprising the act of disposing a clip adjacent the opening to further seal the opening closed.

15. The method according to claim 11, further comprising the act of delivering a sealant to the opening.