Therapeutic agent delivery system, device and method for localized application of therapeutic substances to a biological conduit

• US 8,974,519 B2
• Filed: 02/17/2011
• Issued: 03/10/2015
• Est. Priority Date: 02/19/2010
• Status: Active Grant

• Current Assignee: Cardiovascular Systems Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiovascular Systems Incorporated (Boston Scientific Corporation)
• Inventors: Gennrich, David J., McBroom, Jeffrey A., Jensen, Kristina Tibesar, Rivers, Jody Lee
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Ganesan, Suba
• Application Number:
  US13/029,379
• Publication Number:
  US 20110208221A1
• Time in Patent Office: 1,482 Days
• Field of Search: 623/1.1, 623/1.11, 623/1.13, 623/1.16, 623/1.23, 623/1.25, 623/1.28, 623/1.29, 623/1.38, 623/1.42, 623/1.43, 623/1.44, 623 2364- 2367, 623/23.7
• US Class Current: 623/1.42
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/22002 preventing restenosis
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/003 differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61L 2300/604 Biodegradation
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027

Abstract

The invention provides a system, device and method for localized application of therapeutic substances within a biological conduit. In various embodiments, a dissolvable bag or bolus of at least one therapeutic agent is introduced and pressed and/or sealed against the wall of conduit. In other embodiments, dissolvable barbs formed from at least one therapeutic agent are ejected from a catheter by fluid pressure, embedding in the wall of conduit.

Claims

1. A system for local delivery and application of a bolus of at least one therapeutic agent to the inner wall of a biological conduit following a procedure to open the biological conduit by treating an occlusion therein, comprising:

an expandable stent having an outer surface, the stent capable of delivery to the biological conduit and then expanding within the conduit; and

a bag comprising a first dissolvable or biodegradable material and a second dissolvable or biodegradable material, the bag containing a dose of at least one therapeutic agent therein;

wherein the bag is disposed on the outer surface of the expandable stent, the second dissolvable or biodegradable material is attached to, and wraps continuously radially around, the outer surface of the expandable stent, wherein the first dissolvable or biodegradable material is pressured and disposed against the inner wall of the biological conduit as a result of the pressuring of the expanding stent against the second dissolvable or biogradeable material,

wherein the first dissolvable or biodegradable material dissolves or biodegrades before the second dissolvable or biodegradable material dissolves or biodegrades such that when the first dissolvable or biodegradable material dissolves or biodegrades, the dose of the at least one therapeutic agent is thereby exposed to the inner wall of the biological conduit, and

wherein the pressure of the expanding stent against the second dissolvable or biodegradable material retains the dose of the at least one therapeutic agent in place to treat the trauma until the second dissolvable or biodegradable material dissolves or biodegrades.

2. The system of claim 1, wherein the at least one therapeutic agent comprises an antirestenosis drug.

3. The system of claim 2, wherein the antirestenosis drug comprises a cytoskeletal inhibitor.

4. The system of claim 2, wherein the antirestenosis drug comprises a smooth muscle inhibitor.

5. The system of claim 2, wherein the antirestenosis drug is selected from the group consisting of:

taxol, taxotere, paclitaxel, abraxane, and coroxane.

6. The system of claim 1, wherein the at least one therapeutic agent is selected from the group consisting of an anti-coagulant agent, an anti-proliferative agent, an anti-inflammatory agent, a vascular cell growth inhibitor, a cholesterol-lowering agent, a vasodilating agent, an anti-oxidant, an antibiogtic agent, digoxin, beta-blockers, angiotensin-converting enzyme, captopril, an anesthetic agent, and enalopril.

7. The system of claim 1, wherein the at least one therapeutic agent is selected from the group consisting of heparin, an antithrombin compound, a platelet receptor antagonist, an anti-thrombin antibodies, an anti-platelet receptor antibody, dipyridamole, protamine, hirudin, a prostaglandin inhibitor, a platelet inhibitor, a vascular cell growth promotor and urokinase.

8. The system of claim 1, wherein the at least one therapeutic agent is selected from the group consisting of enoxaparin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, acetylsalicylic acid, amlodipine, and doxazosin.

9. The system of claim 1, wherein the at least one therapeutic agent is selected from the group consisting of glucocorticoids, betamethasone, dexamethasone, prednisolone, corticosterine, budesonide, estrogen, sulfasalazine, and mesalamine.

10. The system of claim 1, wherein the at least one therapeutic agent is selected from the group consisting of whole bone marrow, bone marrow derived mono-nuclear cells, progenitor cells, stem cells, pluripotent stem cells, fibroblasts, magrophages and satellite cells.

11. The system of claim 10, wherein the progenitor cells further comprise endothelial progenitor cells.

12. The system of claim 10, wherein the stem cells are selected from the group consisting of mesenchymal cells, hematopoietic cells and neuronal cells.

13. The system of claim 10, wherein the at least one therapeutic agent is selected from the group consisting of autologous origin cells, allogeneic origin cells, xenogeneic origin cells and genetically engineered cells.

14. The system of claim 1, wherein the at least one therapeutic agent is selected from the group consisting of DNA, RNA, viral vectors, and non-viral vectors.

15. The system of claim 1, wherein the at least one therapeutic agent is selected from the group consisting of cells, yeasts, bacteria, proteins, peptides, cytokines and hormones.