Biopsy localization method and device

• US 10,010,380 B2
• Filed: 09/16/2004
• Issued: 07/03/2018
• Est. Priority Date: 06/22/1998
• Status: Expired due to Fees

• Current Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Original Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Inventors: Fulton, Richard E., Dubrul, William Richard
• Primary Examiner(s): Stout, Michael C
• Application Number:
  US10/943,433
• Publication Number:
  US 20050033195A1
• Time in Patent Office: 5,038 Days
• Field of Search: 600431, 600562, 600492, 623 134, 623 115, 623 147, 623 1111, 623 1611, 623 11, 424 951, 424 952, 424600, 424422, 424551, 606198, 606213, 606151, 128887, 6041031, 604500
• 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 17/3421 Cannulas
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/3962 palpable
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 6/502 for diagnosis of breast, i.e. mammography
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

Methods for localizing a biopsy site are disclosed. The method includes taking a tissue sample from a biopsy site and positioning a detectable, bioabsorbable element at the biopsy site at the time that the tissue sample was taken. The tissue sample is then tested. The biopsy site is then relocated by finding the bioabsorbable element. The bioabsorbable element may be made of collagen, gelatin, cellulose, polylactic acid, and/or polyglycolic acid. The detectable bioabsorbable element may be relocated using ultrasound or mammography. The bioabsorbable element may also swell upon contact with body fluid.

Claims

1. A biopsy method comprising:

positioning a sheath and a biopsy needle with respect to a target site in tissue to be biopsied;

extending the biopsy needle at least partially through the sheath;

removing at least one tissue biopsy sample from the target site through the biopsy needle;

removing the biopsy needle from the sheath while leaving the sheath positioned in the tissue at the target site;

after the step of removing the biopsy needle, inserting a delivery device into the sheath, wherein the delivery device comprises at least one dehydrated bioabsorbable element including starch; and

delivering the bioabsorbable element from the delivery device to the target site from which the tissue biopsy sample was removed.

2. The method of claim 1, further comprising relocating a biopsy site from which the tissue biopsy sample was removed by imaging the bioabsorbable element.

3. The method of claim 2, further comprising testing the tissue biopsy sample removed prior to the step of relocating the site.

4. The method of claim 1, wherein the bioabsorbable element has a pre-delivery state different from a post-delivery state.

5. The method of claim 1, wherein the bioabsorbable element has one consistency in the delivery device, and wherein the bioabsorbable element has a different consistency at a time after being delivered into the site from which tissue was removed.

6. A breast biopsy localization method comprising:

positioning a sheath having a distal end with respect to a target site in breast tissue to be biopsied;

taking a tissue sample from the target site within a patient by a needle biopsy device passing through and extending from the distal end of the sheath so as to create a biopsy site;

removing the biopsy needle from the sheath while leaving the sheath in the breast tissue;

without removing the sheath from the breast tissue, and after removing the biopsy needle from the sheath, inserting a bioabsorbable element delivery device into the sheath, wherein the bioabsorbable element delivery device contains at least one detectable bioabsorbable element;

deploying the at least one detectable bioabsorbable element through the bioabsorbable element delivery device to mark the biopsy site from which the tissue sample was taken.

7. The method of claim 6, further including the step of relocating the biopsy site by imaging to find the detectable bioabsorbable element.

8. The method of claim 7, wherein the step of relocating the biopsy site by imaging comprises detecting the bioabsorbable element with ultrasound.

9. The method of claim 6, wherein the biopsy needle comprises a laterally directed side opening, and wherein the step of inserting the biopsy needle through and extending from the distal end of the sheath comprises positioning the laterally directed side opening beyond the distal end of the sheath.

10. The method of claim 6, wherein the detectable bioabsorbable element comprises a material selected from the group consisting of collagen, proteins, gelatins, starches, polysaccharides, ceramics, polyamino acids and hydrogels.

11. The method of claim 7, wherein the detectable bioabsorbable element has a pre-delivery state prior to its delivery to the target site, and a post-delivery state after being deployed to the target site, and wherein the post-delivery state is physically different from the pre-delivery state.

12. The method of claim 7, wherein the step of relocating the biopsy site comprises locating the detectable bioabsorbable element after the detectable bioabsorbable element swells from its pre-delivery state to its post-delivery state.