Device and method for facilitating hemostasis of a biopsy tract

• US 6,086,607 A
• Filed: 02/10/1999
• Issued: 07/11/2000
• Est. Priority Date: 05/01/1998
• Status: Expired due to Term

• Current Assignee: Allen Family Trust, Andrew H. Cragg, Boston Scientific Scimed (Boston Scientific Corporation), Bruce Feuchter, FirstMark II LP (FirstMark Capital, LLC), Geoffrey O. Hartzler, George Wallace, Pacific Venture Group II, L.P., PVG Associates II, L.P., Kingsbury Capital Partners, L.P. III (Timothy J. Wollaeger, MBA), Kingsbury Capital Partners, L.P. IV (Timothy J. Wollaeger, MBA)
• Original Assignee: Sub-Q, Inc. (Merit Medical Systems, Inc.)
• Inventors: Cragg, Andrew H., Ashby, Mark, Brenneman, Rodney
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRINH, HOA B
• Application Number:
  US09/247,880
• Time in Patent Office: 517 Days
• Field of Search: 606/212-214, 606/144, 604/59, 604/60, 604/38, 604/51-54, 604/265, 604/270, 604/264, 604/15
• US Class Current: 606/213
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• 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 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 2017/00654 entirely comprised between the two sides of the opening

Abstract

A system including an adaptor and a syringe is used for facilitating hemostasis of a biopsy tract or other puncture wound by delivery of an absorbable sponge in a hydrated state into the wound. The adaptor includes a tapered lumen for hydrating and compressing the relatively large absorbable sponge for delivery through a relatively small cannula, such as a biopsy needle. The hydrated absorbable sponge is injected through the biopsy needle into the biopsy tract by fluid. Alternatively, the sponge may be delivered to the biopsy needle by injection of fluid and then delivered to the biopsy tract by a plunger or stylet. The implanted absorbable sponge facilitates hemostasis at the biopsy site or other puncture wound and minimizes the chance of internal bleeding. The absorbable sponge material is absorbed by the body over time.

Claims

1. A system for injecting a sponge into tissue, the system comprising:

a pledget of sponge having a proximal end with a larger cross sectional area than a distal end;

a cannula for delivering the pledget in a hydrated state to the tissue; and

an adaptor connectable to the cannula for hydrating and delivering the pledget to the cannula, the adaptor having a tapered lumen with a large diameter proximal end and a small diameter distal end, wherein the small diameter distal end is connectable to the cannula.

2. The system of claim 1, wherein the pledget is formed from a sheet of sponge material which is folded to form the larger cross sectional proximal end.

3. The system of claim 1, wherein the pledget proximal end has a cross sectional area of about 1.2 to 4 times a cross sectional area of the distal end.

4. The system of claim 1, wherein the pledget proximal end with the larger cross sectional area extends along 1/8 to 3/4 of total length of the pledget.

5. The system of claim 1, wherein the sponge is an absorbable sponge material.

6. A method of forming a sponge pledget for delivery to tissue, the method comprising:

cutting a strip of sponge from a sheet of sponge material; and

folding the strip to form a pledget with a first end having a first cross sectional area and a second folded end having a second cross sectional area which is larger than the first cross sectional area.

7. The method of claim 6, wherein the strip is cut with the aid of a template.

8. The method of claim 7, wherein the template is attached to a device for hydrating and delivering the pledget.

9. The method of claim 6, wherein a crease is formed in the strip by a cutting template and the strip is folded along the crease.

10. A system for preparing and delivering a hydrated sponge to a cannula for delivery to tissue, the system comprising:

an adaptor comprising;

an elongated member having a first end, a second end, and a lumen extending from the first end to the second end;

a luer connector provided at the second end for connection to a cannula; and

a tapered section of the lumen tapering from a first diameter at the first end to a second diameter at the second end which is smaller than the first diameter such that a dry sponge pledget having a width larger than the second diameter is compressible when hydrated to allow passage of the pledget into the second diameter; and

a template configured for use in cutting the sponge to a size to be received in the elongated member for delivery to the cannula.

11. The adaptor of claim 10, wherein the template includes a recess sized and shaped to form an elongated strip of sponge.

12. The adaptor of claim 10, wherein the template includes a cutting edge for cutting along with a blade to form a strip of sponge and a creasing bar for forming a crease across the strip.

13. The adaptor of claim 10, wherein the template is attached to the elongated member.

14. An adaptor system for delivering a hydrated sponge to a cannula for delivery to tissue, the system comprising:

an elongated adaptor having a distal end, a proximal end, a lumen tapering from a larger diameter at a proximal end to a smaller diameter at the distal end, and a luer connection at the distal end; and

a removable vent cap configured to engage the luer connection, the vent cap having a vent hole which allows fluid to pass out of the adaptor but prevents the sponge from passing through the vent hole.

15. The adaptor system of claim 14, wherein the vent cap is configured to position a distal end of the sponge at a predetermined longitudinal position with respect to the adaptor.

16. The adaptor system of claim 15, wherein the predetermined longitudinal position is proximal of the distal end of the adaptor.

17. The adaptor system of claim 14, wherein the vent cap includes a conical portion configured to extend into the distal end of the adaptor.

18. The adaptor system of claim 17, wherein the vent hole is provided at a tip of the conical portion.

19. A method of delivering a sponge into a tissue access tract comprising:

delivering a hydrated sponge pledget through a cannula positioned in a tissue access tract at a velocity E while withdrawing the cannula from the tissue at a velocity V to deposit the sponge pledget and seal the tissue access tract, wherein the velocity E is greater than or equal to the velocity V.

20. The method of claim 19, wherein the velocity E is provided by injection of a fluid.

21. The method of claim 19, wherein the velocity E is provided by a plunger.

22. The method of claim 19, wherein a portion of the tissue access tract being filled spans two or more anatomical structures.