Subcutaneous cavity marking device

• US 8,320,993 B2
• Filed: 03/13/2001
• Issued: 11/27/2012
• Est. Priority Date: 12/24/1998
• Status: Expired due to Term

• Current Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Original Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Inventors: Sirimanne, D. Laksen, Sutton, Douglas S., Fawzi, Natalie V., Lebovic, Gail
• Primary Examiner(s): Smith, Ruth S
• Application Number:
  US09/805,652
• Publication Number:
  US 20020035324A1
• Time in Patent Office: 4,277 Days
• Field of Search: 600/407, 600/414, 600/420, 600/426, 600/431, 600/432, 600/436, 600 2- 4, 600/7, 600/26.6, 600/36, 600/562, 604/53, 604/265, 424/426, 424422-423, 606/130, 606/194, 606/196, 623/1, 623/11, 623/12
• US Class Current: 600/431
• 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 8/481 involving the use of contrast agent, e.g. microbubbles introduced into the bloodstream analysis of echo signal exploiting properties of a contrast enhancer in devices for short-range imaging with acoustic waves G01S7/52039
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61K 49/006 Biological staining of tissues in vivo, e.g. methylene blue or toluidine blue O administered in the buccal area to detect epithelial cancer cells, dyes used for delineating tissues during surgery
• CPC Class Codes: A61K 49/222 characterised by a special physical form, e.g. emulsions, liposomes

Abstract

These are subcutaneous cavity marking devices and methods. More particularly, upon insertion into a body, the cavity marking device and method enable one to determine the center, orientation, and periphery of the cavity by radiographic, mammographic, echogenic, or other non-invasive imaging techniques. Also, the device contains a bioabsorbable or non-bioabsorbable marker. The device may be combined with various substances enhancing the radiopaque, mammographic, or echogenic characteristics of the marker or the body allowing it to be observed by any non-invasive imaging techniques. This is further a method of marking a subcutaneous cavity using a bioabsorbable material and a bioabsorbable or non-bioabsorbable marker in conjunction with the material. The method also may combine any of the features as described with the device.

Claims

1. A subcutaneous cavity marking device percutaneously implantable in breast tissue during a biopsy procedure comprising:

at least two implantable bodies, one made from a first material and another made from a second material wherein the first and second materials are different materials and the at least two implantable bodies are adapted to be inserted into a subcutaneous cavity created by removal of tissue, wherein the at least two implantable bodies are detectable via non-invasive techniques as tissue cavity markers; and

at least one of the at least two detectable bodies has a distinguishing pattern and is disposed within the other of the at least two implantable bodies wherein the other of the at least two implantable bodies is bioabsorbable.

2. The device of claim 1 wherein the at least one of the at least two detectable bodies comprises a non-bioabsorbable material forming a permanent marker.

3. The device of claim 2 wherein the permanent marker comprises a material selected from the group consisting of platinum, iridium, nickel, tungsten, tantalum, gold, silver, rhodium, titanium, alloys thereof and stainless steel.

4. The device of claim 1 wherein the at least one of the at least two detectable bodies comprises a bioabsorbable material.

5. The device of claim 4 wherein the bioabsorbable material comprises a polymer having a radiopaque additive.

6. The device of claim 5 wherein the radiopaque additive is selected from the group consisting of barium-containing compounds, bismuth-containing compounds, powdered tantalum, powdered tungsten, barium carbonate, bismuth oxide, and barium sulfate.

7. The device of claim 1 wherein the at least one of the at least two detectable bodies is radiopaque.

8. The device of claim 1 additionally comprising a pain killing substance.

9. The device of claim 1 additionally comprising a hemostatic substance.

10. The device of claim 1 wherein the at least one of the at least two implantable bodies comprises a suture in a pattern which crosses.

11. The device of claim 1 wherein the at least one of the at least two implantable bodies comprises a wire in a pattern which crosses.

12. The device of claim 1 wherein one of the at least two implantable bodies is detectable via ultrasound.

13. The device of claim 1 wherein the at least two implantable bodies have a substantially irregular shape.

14. The device of claim 1 wherein the at least two implantable bodies have a plurality of pores.

15. The device of claim 14 wherein the pores are configured to promote tissue growth in a preferred orientation.

16. The device of claim 1 wherein one of the at least two implantable bodies is made from an expandable material.

17. The device of claim 1 wherein one of the at least two implantable bodies has a plurality of pores.

18. The device of claim 1 wherein one of the at least two implantable bodies is formed in a cross pattern to mark a particular section of said cavity.

19. The device of claim 1 wherein the at least one of the at least two detectable bodies includes an identifying mark.

20. The device of claim 19 wherein the identifying mark comprises one or more numbers, letters, symbols, or combinations thereof.