Device and method for facilitating hemostasis of a biopsy tract

• US 6,846,320 B2
• Filed: 09/24/2001
• Issued: 01/25/2005
• 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: Sing, Eduardo Chi, Ashby, Mark, Whalen, Vaughn P.
• Primary Examiner(s): Reip, David O.
• Assistant Examiner(s): Baxter, Jessica R.
• Application Number:
  US09/960,389
• Publication Number:
  US 20020016612A1
• Time in Patent Office: 1,219 Days
• Field of Search: 606/213, 606/214, 606/216, 606/116, 604 96-104, 600562-567
• US Class Current: 606/213
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• 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
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

A biopsy cannula and a delivery catheter are configured to deliver one or more absorbable sponge pledgets to a biopsy site after removal of one or more tissue samples from the site. The delivery catheter allows a large amount of hydrated sponge material to be delivery to the biopsy site to facilitate hemostasis. One example of the delivery catheter includes a closed distal end, a side port, a tapered section, and an enlarged proximal portion for receiving the pledget. The side port of the delivery catheter is arranged to delivery the pledget through the side port of the biopsy cannula. In order to fill a relatively large biopsy site where multiple tissue samples have been taken in a radial pattern, the biopsy cannula is rotated and additional pledgets are delivered to the biopsy site at different radial locations. The absorbable sponge pledget may also be used as a marker for location of the biopsy site at a later time.

Claims

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

a catheter having a closed distal end and a side port adjacent the distal end for delivering a pledget of sponge material in a hydrated state to the tissue; and

an adaptor connected to the catheter designed to hydrate and deliver the pledget to the catheter, 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 connected to the catheter, and wherein the adaptor is removable from the catheter.

2. The system of claim 1, wherein the adaptor is fixed to the catheter.

3. The system of claim 1, further comprising a biopsy cannula having a tissue puncturing distal end and a side port positioned adjacent the distal end, wherein the catheter is configured to fit within the biopsy cannula to deliver the pledget to the tissue.

4. The system of claim 3, wherein the biopsy cannula includes a first indexing member and the catheter includes a second indexing member for radially aligning the catheter with the cannula.

5. The system of claim 4, wherein the first and second indexing members include at least one projection and at least one corresponding recess.

6. The system of claim 3, wherein the biopsy cannula is a breast biopsy cannula.

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

a catheter having a closed distal end and a side port adjacent the distal end for delivering a pledget of sponge material in a hydrated state to the tissue;

an adaptor connected to the catheter designed to hydrate and deliver the pledget to the catheter, 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 connected to the catheter; and

a pledget of sponge material preloaded in the adapter.

8. The system of claim 7, wherein the sponge is an absorbable sponge material.

9. The system of claim 7, wherein the sponge contains a radiopaque marker.

10. The system of claim 7, wherein the adaptor and pledget of sponge material are arranged to deliver the pledget to the catheter.

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

a catheter having a side port adjacent the distal end for delivering a pledget of sponge material in a hydrated state to the tissue;

an adaptor connected to the catheter designed to hydrate and deliver the pledget to the catheter, 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 connected to the catheter; and

a pledget of radipaque sponge material loaded in the adapter.