Apparatus and methods for facilitating access through a puncture including sealing compound therein

• US 20050245876A1
• Filed: 04/22/2005
• Published: 11/03/2005
• Est. Priority Date: 12/24/2003
• Status: Abandoned Application

• Current Assignee: Access Closure Incorporated (Cardinal Health, Inc.)
• Original Assignee: Access Closure Incorporated (Cardinal Health, Inc.)
• Inventors: Khosravi, Farhad, Pai, Suresh S.
• Application Number:
  US11/112,970
• Publication Number:
  US 20050245876A1
• Time in Patent Office: Days
• US Class Current: 604/164.100
• 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 17/3431 being collapsible, e.g. made of thin flexible material A61B17/3423 takes precedence
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/0065 the implement being an adhesive
• CPC Class Codes: A61B 2017/3435 using everted sleeves
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

Apparatus for delivering a sleeve into a puncture through tissue includes a tubular sheath including a lumen extending between its proximal end and an opening in its distal end. The sleeve includes a hub on a first end thereof disposed adjacent the distal end of the sheath, and a second end extending into the opening and lumen of the sheath. The hub is slidable along an exterior of the sheath for drawing the sleeve out of the opening and along an exterior of the sheath. During use, a guide wire is placed through the puncture into a blood vessel, and sealing compound is introduced into the puncture around the guide wire. The sheath is advanced into the puncture over the guidewire while maintaining the hub adjacent the patient'"'"'s skin, causing the sleeve to be deployed from the sheath and line the puncture as the sheath is advanced into the puncture.

Claims

1. Apparatus for introducing an instrument into a body lumen of a patient through a puncture extending from the patient'"'"'s skin to the body lumen, comprising:

a guidewire;

a sealing compound in a form that can be delivered into the puncture around the guidewire; and

an instrument introducer assembly comprising

a tubular sheath having a proximal end, a distal end shaped for insertion into the puncture, and a lumen extending from the proximal end to an opening in the distal end, and

a flexible, thin-walled sleeve comprising first and second ends, and a hub on the first end disposed adjacent the distal end of the sheath, the second end extending into the distal opening and lumen of the sheath, the hub being slidable along an exterior of the sheath for drawing the sleeve out of the distal sheath opening and along the sheath exterior.

2. The apparatus of claim 1, wherein the sleeve is expandable from a contracted condition when disposed within the lumen of the sheath to an expanded condition when removed from the sheath lumen.

3. The apparatus of claim 2, wherein the sleeve is collapsed into the contracted condition.

4. The apparatus of claim 1, wherein the sleeve is substantially nonporous.

5. The apparatus of claim 2, wherein the sleeve comprises substantially inelastic material, such that the sleeve defines a predetermined diameter in the expanded condition.

6. The apparatus of claim 1, wherein the sleeve comprises a lubricious coating on at least one of an inner surface and an outer surface.

7. The apparatus of claim 1, wherein the sleeve is separable along one or more seams extending between the first and second ends.

8. The apparatus of claim 1, the instrument introducer assembly further comprising a tubular dilator slidably disposed within the lumen of the sheath, the second end of the sleeve being disposed within a lumen of the dilator.

9. The apparatus of claim 1, further comprising means for delivering the sealing compound into the puncture around the guidewire.

10. The apparatus of claim 1, further comprising a delivery assembly for delivering the sealing compound into the puncture around the guidewire, the delivery assembly including a tubular sheath having a first lumen sized for allowing passage there through of the guidewire, and a second lumen at least partially surrounding and isolated from the first lumen, the second lumen in communication with an inlet port for receiving the sealing compound and one or more outlet ports arranged to dispense the sealing compound within the puncture around the guidewire.

11. A method for lining a puncture extending from a patient'"'"'s skin to a body lumen using a tubular sheath and a flexible, thin-walled sleeve disposed within a lumen of the tubular sheath, the sleeve comprising a hub on a first end thereof adjacent a distal end of the sheath and a second end disposed within the lumen of the sheath, the method comprising:

placing a guide wire through the puncture from the patient'"'"'s skin into the body lumen;

introducing a sealing compound into the puncture around at least a portion of the guide wire;

placing the hub of the sleeve adjacent the patient'"'"'s skin; and

advancing the sheath into the puncture over the guidewire, while maintaining the hub adjacent the patient'"'"'s skin, causing the sleeve to be deployed from the lumen of the tubular sheath and cover an exterior of the sheath to thereby line the puncture as the sheath is advanced into the puncture.

12. The method of claim 11, wherein the sheath is advanced into the puncture until the distal end of the sheath is disposed within the body lumen, the sleeve having sufficient length to extend from the hub adjacent the patient'"'"'s skin to the body lumen.

13. The method of claim 12, further comprising introducing an instrument through the sheath into the body lumen to perform a procedure within the patient'"'"'s body.

14. The method of claim 13, further comprising removing the sheath from the puncture after completing the procedure.

15. The method of claim 14, wherein the sleeve is removed from the puncture substantially simultaneously with removing the sheath from the puncture.

16. The method of claim 14, wherein the sleeve is removed from the puncture prior to the sheath.

17. The method of claim 16, wherein the sleeve is separated along one or more seams as it is removed from the puncture to allow the sleeve to be removed from around the sheath.

18. The method of claim 11, further comprising loading the guidewire through the lumen of the sheath, the sheath being advanced over the guidewire when the sheath is introduced into the puncture.

19. The method of claim 11, wherein the guidewire extends through the sleeve when the guidewire is loaded through the lumen of the sheath.

20. A system for introducing an instrument into a body lumen of a patient through a puncture extending from the patient'"'"'s skin to the body lumen, comprising:

a sealing compound delivery assembly including

a sealing compound, and

a tubular sheath having a first lumen sized for allowing passage there through of a guidewire, and a second lumen at least partially surrounding and isolated from the first lumen, the second lumen in communication with an inlet port for receiving the sealing compound and one or more outlet ports for dispensing the sealing compound within the puncture while a guidewire is positioned in the first lumen; and

an instrument introducer assembly including

a tubular sheath having a proximal end, a distal end shaped for insertion into the puncture, and a lumen extending from the proximal end to an opening in the distal end, and

a flexible, thin-walled sleeve comprising first and second ends, and a hub on the first end disposed adjacent the distal end of the sheath, the second end extending into the distal opening and lumen of the sheath, the hub being slidable along an exterior of the sheath for drawing the sleeve out of the distal sheath opening and along the sheath exterior.