Free-standing biodegradable patch

• US 10,391,204 B2
• Filed: 07/21/2017
• Issued: 08/27/2019
• Est. Priority Date: 09/18/2009
• Status: Active Grant

• Current Assignee: BioInspire Technologies, Inc.
• Original Assignee: BioInspire Technologies, Inc.
• Inventors: Hakimimehr, Dorna, Bonan, Raoul
• Primary Examiner(s): Wax, Robert A
• Assistant Examiner(s): Mercier, Melissa S
• Application Number:
  US15/656,918
• Publication Number:
  US 20170319752A1
• Time in Patent Office: 767 Days
• Field of Search: None
• CPC Class Codes: A61K 38/363 Fibrinogen
• CPC Class Codes: A61K 38/4833 Thrombin (3.4.21.5)
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 9/7007 Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence
• CPC Class Codes: A61K 9/7046 the adhesive comprising macromolecular compounds
• CPC Class Codes: A61K 9/7084 Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
• CPC Class Codes: A61L 2300/216 with other specific functional groups, e.g. aldehydes, ketones, phenols, quaternary phosphonium groups
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/254 Enzymes, proenzymes
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/041 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 31/046 Fibrin; Fibrinogen
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/141 Plasticizers
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61P 17/02 : for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 31/00 : Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 37/08 : Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: A61P 7/02 : Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: A61P 9/12 : Antihypertensives
• CPC Class Codes: C12Y 304/21005 : Thrombin (3.4.21.5)

Abstract

Methods and apparatus for a free-standing biodegradable patch suitable for medical applications, especially intravascular, minimally-invasive and intraoperative surgical applications are provided, wherein the patch comprises a free-standing film or device having a mixture of a solid fibrinogen component and a solid thrombin component that, when exposed to an aqueous environment, undergoes polymerization to form fibrin. In alternative embodiments the patch may comprise a solid fibrinogen component, with or without an inorganic calcium salt component. The patch may take a non-adherent form during delivery to a target location within a vessel or tissue, and thereafter may be activated to adhere to vessel wall or tissue, and may include a number of additives, including materials to improve the mechanical properties of the patch, or one or more therapeutic or contrast agents.

Claims

1. A device for treatment comprising:

a film that is biocompatible, biodegradable, and adapted to adhere to tissue at or adjacent to a sinus of a patient, the film integrally formed, prior to adherence to the tissue, of at least a first adhesive layer comprising an amount of unreacted, purified human fibrinogen prepared without excipients selected to transition the film to a temporary gel state upon exposure to an aqueous environment, the first adhesive layer adjoined to a second layer comprising and a therapeutic agent configured to be released into the tissue, the first adhesive layer further comprising a plasticizer in an amount of up to 0.5 mg per mg of fibrinogen,

wherein, in the temporary gel state, the film is freely manipulatable and deformable to adhere to the tissue.

2. The device of claim 1, wherein the film comprises a radiopaque material.

3. The device of claim 1, wherein the film further comprises thrombin.

4. The device of claim 1, wherein the therapeutic agent comprises a steroidal anti-inflammatory agent.

5. The device of claim 1, wherein the therapeutic agent is fluticasone propionate.

6. The device of claim 1, wherein the therapeutic agent comprises anti-inflammatory agents, anti-allergenic agents, anti-bacterial agents, anti-viral agents, anticholinergic agents, antihistamines, antithrombotic agents, anti-scarring agents, antiproliferative agents, antihypertensive agents, anti-restenosis agents, healing promoting agents, vitamins, proteins, genes, growth factors, cells or DNA.

7. The device of claim 1, further comprising one or more additional therapeutic agents configured to be released into the tissue.

8. The device of claim 7, wherein the one or more additional therapeutic agents comprise anti-inflammatory agents, anti-allergenic agents, anti-bacterial agents, anti-viral agents, anticholinergic agents, antihistamines, antithrombotic agents, anti-scarring agents, antiproliferative agents, antihypertensive agents, anti-restenosis agents, healing promoting agents, vitamins, proteins, genes, growth factors, cells or DNA, or combinations thereof.

9. The device of claim 1, wherein the film has a thickness between 30-500 μ

m.

10. The device of claim 1, wherein the film further comprises a dye.

11. The device of claim 1, wherein the film is coated with a water-soluble protective layer.

12. The device of claim 1, further comprising a delivery system for approximating and conforming the film to the tissue.

13. The device of claim 12, wherein the delivery system comprises an expandable member and the film is configured to be disposed upon, and delivered by, the expandable member.

14. A method of delivering a device to tissue, the method comprising:

advancing a film of claim 1 to the tissue at or adjacent to the sinus; and

applying the film to the tissue.

15. The method of claim 14, wherein the film is advanced under endoscopic guidance.