Device and method for facilitating hemostasis of a biopsy tract

• US 6,200,328 B1
• Filed: 06/16/1999
• Issued: 03/13/2001
• Est. Priority Date: 05/01/1998
• Status: Expired due to Fees

• 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:
  US09/334,700
• Time in Patent Office: 636 Days
• Field of Search: 606/213, 606/215, 604/240, 604/51, 604/411, 604/256, 604/534, 604/241-243, 604/285, 604/272, 600/577
• 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 system may also include a trail staging chamber for inspecting a condition of the sponge before delivery. 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 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 allowing passage of fluid through the adaptor;

a fitting 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 transparent visualization chamber connectable to the fitting provided at the second end of the elongated member.

2. The system of claim 1, wherein the transparent visualization chamber is an elongated chamber having a constant diameter along its length.

3. The system of claim 1, wherein an interior diameter of the transparent visualization chamber is approximately equal to or less than the second diameter of the adapter lumen.

17. The system of claim 1, wherein the adaptor includes a luer fitting at the first end for connection of the adaptor to a syringe.

18. The system of claim 1, wherein the lumen extending from the first end to the second end of the adaptor is configured to allow passage of the hydrated pledget.

4. 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 fitting 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;

a transparent visualization chamber connectable to the fitting provided at the second end of the elongated member; and

a removable vent cap configured to engage both the second end of the elongated member and a distal end of the transparent visualization chamber.

5. 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 fitting 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;

a transparent visualization chamber connectable to the fitting provided at the second end of the elongated member; and

a removable vent cap configured to engage a distal end of the transparent visualization chamber.

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

an adaptor having a tapered lumen allowing passage of fluid through the adaptor, the lumen tapering from a first diameter at a first end to a second diameter at a second end which is smaller than the first diameter; and

a trail staging chamber removably connectable to the second end of the adaptor and having a lumen with a substantially constant diameter which is equal to or less than the second diameter of the adaptor lumen.

7. The system of claim 6, wherein the trial staging chamber is transparent.

8. The system of claim 6, wherein the adaptor include a first luer fitting at a distal end for connection to a cannula or chamber and a second luer fitting at a proximal end for connection of the adaptor to a syringe.

13. The system of claim 6, further comprising a removable vent cap configured to engage both the second end of the adaptor and a distal end of the trail staging chamber.

14. The system of claim 6, further comprising a removable vent cap configured to engage a distal end of the trail staging chamber.

15. The system of claim 6, further comprising a removable vent cap configured to engage the second end of the adaptor.

16. The system of claim 6, wherein the lumen extending from the first end to the second end of the adaptor is configured to allow passage of the hydrated pledget.

9. A method of facilitating hemostasis of a puncture wound by injecting a sponge through a cannula into the puncture wound, the method comprising:

inserting a pledget of a sponge into an adaptor having a tapered lumen;

connecting the adapter to a transparent visualization chamber and injecting the pledget from the adaptor into the visualization chamber;

visually inspecting the pledget within the visualization chamber to determine a condition of the pledget;

connecting the visualization chamber to a cannula; and

delivering the pledget through the cannula to facilitate hemostasis of a puncture wound.

10. The method according to claim 9, wherein the pledget is elongated as it passes through the adaptor and into the transparent visualization chamber.

11. The method of claim 9, wherein the pledget is hydrated in the adapter prior to delivery of the pledget to the transparent visualization chamber.

12. The method of claim 9, wherein the puncture wound is a biopsy tract and the cannula through which the sponge pledget is delivered is a biopsy needle.

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

a staging chamber for staging a hydrated sponge in preparation for delivery of the hydrated sponge to tissue, the staging chamber having an axial lumen, a first end connectable to a fluid delivery member, and a second end; and

a vent cap removably connectable to the second end of the staging chamber, the vent cap when connected to the staging chamber allowing fluid to pass from the staging chamber through the vent cap, and substantially preventing the hydrated sponge from passing from the staging chamber through the vent cap wherein the vent cap includes a locating surface which positions an end of the hydrated sponge axially in the axial lumen.

20. The system of claim 19, wherein the vent cap includes a locating surface which positions an end of the hydrated sponge axially in the axial lumen.

21. The system of claim 20, wherein th locating surface of the vent cap is positioned within the lumen of the staging chamber when the vent cap is connected to the stageing chamber.