Post-biopsy cavity treatment implants and methods

• US 8,491,630 B2
• Filed: 08/01/2012
• Issued: 07/23/2013
• Est. Priority Date: 07/25/2003
• Status: Expired due to Fees

• Current Assignee: Encapsule Medical, LLC
• Original Assignee: Encapsule Medical, LLC
• Inventors: Chernomorsky, Ary S., Vetter, James W., Chernomorsky, Simon
• Primary Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US13/564,713
• Publication Number:
  US 20120296207A1
• Time in Patent Office: 356 Days
• Field of Search: 606213-216, 623/23.72
• US Class Current: 606/213
• 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 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61K 49/04 X-ray contrast preparations
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61M 31/005 for contrast media

Abstract

An implant for filling a cavity created by an excisional procedure includes first and second portions. The first portion may include a first collagenous matrix that defines a first selected crosslinking density and the second portion may include a second collagenous matrix that defines a second selected cross-linking density that is different than the first cross-linking density. The first and second cross-linking densities may be selected so as to cause the first and second portions to swell in such a manner that the implant swells into a size and a shape that is similar to the predetermined size and shape of the cavity when the implant is implanted. An aqueous solution may be added to the cavity if the cavity is not sufficiently aqueous to cause the implant to swell.

Claims

1. A method for mapping a lymphatic system following a cavity generating procedure, comprising:

providing a post-biopsy cavity treatment implant, the implant including a collagenous matrix having a non-uniform cross-linking density that is configured to cause the implant to swell non-uniformly when placed within an aqueous environment, the implant including a dye or a pigment contained therein;

implanting the provided post-biopsy cavity treatment implant into the cavity;

closing the cavity with the post-biopsy cavity treatment implant implanted therein;

causing the dye/pigment to be released from the implant and to propagate through the lymphatic system, and visualizing the propagated dye/pigment in the lymphatic system using a selected visualization mode.

2. The method of claim 1, wherein the implant in the providing step includes a reservoir disposed within the collagenous matrix, the reservoir containing a volume of the dye/pigment and wherein the causing step includes a step of breaching the reservoir to release the dye/pigment.

3. The method of claim 1, wherein the breaching step includes a step of squeezing the implanted post-biopsy cavity treatment implant.

4. The method of claim 1, wherein the causing step includes a step of waiting for a predetermined period of time during which the implant degrades within the cavity and releases the dye/pigment.

5. The method of claim 1, wherein the at least one of dye and pigment is loaded within the collagenous matrix of the implant.

6. The method of claim 1, wherein visualizing mode in the visualizing step includes at least one of ultrasound, X-ray, MRI, elastography, microwave and the unaided eye.