Tissue marking apparatus having drug-eluting tissue marker

• US 8,486,028 B2
• Filed: 09/30/2011
• Issued: 07/16/2013
• Est. Priority Date: 10/07/2005
• Status: Active Grant

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Original Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Inventors: Field, Steven E.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Hall, Deanna K
• Application Number:
  US13/250,121
• Publication Number:
  US 20120022370A1
• Time in Patent Office: 655 Days
• Field of Search: 604/264, 600/3, 600/431, 600/426, 600/427
• US Class Current: 604/264
• 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 2017/00831 Material properties
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

A tissue marking apparatus includes a marker introducer that has a cannula and a stylet. The cannula has a lumen and a marker exit port. The stylet is slidably received in the lumen. The stylet has a distal end. A tissue marker is configured to be received in the lumen distal to the distal end of the stylet. The tissue marker is a drug-eluting tissue marker for marking a site in a tissue mass, and has a drug-eluting portion having a drug for release to the site and a material that can be imaged using an imaging technique.

Claims

1. A tissue marking apparatus, comprising:

a marker introducer that includes a cannula and a stylet, the cannula having a lumen and a marker exit port, and the stylet being slidably received in the lumen, the stylet having a distal end; and

a tissue marker configured to be received in the lumen distal to the distal end of the stylet, the tissue marker including;

a marker portion configured to mark a site within a soft tissue mass, the marker portion having a length extending along a centerline of the marker portion between a first end and a second end and having a substantially continuous wall along the length, the substantially continuous wall bounding a hollow interior; and

a drug-eluting portion comprising a drug,

wherein the substantially continuous wall that bounds the hollow interior includes at least one opening configured to allow the drug to pass out of the hollow interior.

2. The tissue marking apparatus of claim 1, wherein the at least one opening comprises a plurality of pores.

3. The tissue marking apparatus of claim 1, wherein the marker portion comprises a structure that resists migration of the tissue marker from a tissue site.

4. The tissue marking apparatus of claim 3, wherein the structure includes an anchor.

5. The tissue marking apparatus of claim 1, wherein the marker portion comprises a substrate and the drug-eluting portion comprises a coating on the substrate.

6. The tissue marking apparatus of claim 1, wherein the marker portion is configured to dissolve at a predetermined rate.

7. The tissue marking apparatus of claim 1, wherein at least one of the marker portion and the drug eluting portion is formed from an imageable material.

8. The tissue marking apparatus of claim 1, wherein the drug includes at least one of an anti-inflammatory, antiplatelet, anticoagulant, antifebrin, antithrombin, cytostatic, antiproliferative, antibiotic, antimicrobial, antioxidant, antiallergic, antitumor, chemotherapeutic, antineoplastic, antimitotic, thrombolytic, fibrinolytic, vasodilator, antiviral, antihypertensive, antisecretory, immunosuppressive, growth factor, growth factor antagonist;

antipolymerase, photodynamic therapy, antibody targeted therapy, prodrug, sex hormone, free radical scavengers, radiotherapeutic, radiopaque, radiolabelled, peptides, proteins, and enzyme substance.

9. The tissue marking apparatus of claim 1, wherein the marker portion is non-prosthetic.

10. A tissue marking apparatus, comprising:

a marker introducer that includes a cannula and a stylet, the cannula having a lumen and a marker exit port, and the stylet being slidably received in the lumen, the stylet having a distal end; and

an imaging marker configured to be received in the lumen distal to the distal end of the stylet, the imaging marker including a marker portion and a drug-eluting portion, with at least one of the marker portion and the drug-eluting portion being imageable, the marker portion having a length extending along a centerline of the marker portion between a first end and a second end and having a substantially continuous wall along the length, the substantially continuous wall bounding a hollow interior and at least partially encapsulating the drug eluting portion within the hollow interior, and wherein the length of the marker portion is greater than an average diameter of the hollow interior and the substantially continuous wall includes at least one opening adapted to allow the drug to pass out of the hollow interior.

11. The tissue marking apparatus of claim 10, wherein the at least one opening comprises a plurality of pores.

12. The tissue marking apparatus of claim 10, wherein the marker portion comprises an imageable substrate and the drug-eluting portion comprises a coating containing the drug applied to the substrate.

13. The tissue marking apparatus of claim 10, wherein the marker portion comprises a substrate of bioabsorbable material containing the drug.

14. A tissue marking apparatus, comprising:

a marker introducer that includes a cannula and a stylet, the cannula having a lumen and a marker exit port, and the stylet being slidably received in the lumen, the stylet having a distal end; and

a tissue marker configured to be received in the lumen distal to the distal end of the stylet, the tissue marker including;

a marker portion configured to mark a site within a soft tissue mass, the marker portion being formed as a body having open ends, and having a substantially continuous wall bounding a hollow interior; and

a drug-eluting portion comprising a drug, wherein the drug-eluting portion is disposed within the hollow interior of the body, and wherein the open ends facilitate a passing of the drug out of the hollow interior of the body to a region outside the body; and

wherein the body is in the form of a tube having a plurality of openings that extend through the wall, and wherein the plurality of openings facilitate the passing of the drug out of the hollow interior of the tube to the region outside the tube.

15. The tissue marking apparatus of claim 14, wherein the marker portion is non-prosthetic.

16. The tissue marking apparatus of claim 14, wherein the marker portion comprises a structure that resists migration of the tissue marker from a tissue site.

17. The tissue marking apparatus of claim 16, wherein the structure includes an anchor.

18. The tissue marking apparatus of claim 14, wherein the marker portion comprises a substrate and the drug-eluting portion comprises a coating on the substrate.

19. The tissue marking apparatus of claim 14, wherein the marker portion is configured to dissolve at a predetermined rate.

20. The tissue marking apparatus of claim 14, wherein at least one of the marker portion and the drug eluting portion is formed from an imageable material.