Multi-layer biodegradable device having adjustable drug release profile

• US 10,159,768 B2
• Filed: 06/15/2017
• Issued: 12/25/2018
• Est. Priority Date: 03/11/2013
• Status: Active Grant

• Current Assignee: BioInspire Technologies, Inc.
• Original Assignee: BioInspire Technologies, Inc.
• Inventors: Hakimimehr, Dorna, Hammerick, Kyle
• Primary Examiner(s): Palenik, Jeffrey T.
• Application Number:
  US15/624,304
• Publication Number:
  US 20170281833A1
• Time in Patent Office: 558 Days
• Field of Search: None
• CPC Class Codes: A61B 17/24 for use in the oral cavity, larynx, bronchial passages or nose for medical inspection of cavities or tubes in the body A61B1/00; Tongue scrapers
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• CPC Class Codes: A61K 9/0002 Galenical forms characterised by the drug release technique; Application systems commanded by energy
• CPC Class Codes: A61K 9/0043 Nose
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 2300/61 containing two or more active agents in different layers
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 31/028 Other inorganic materials not covered by A61L31/022 - A61L31/026
• CPC Class Codes: A61L 31/046 Fibrin; Fibrinogen
• CPC Class Codes: A61L 31/047 Other specific proteins or polypeptides not covered by A61L31/044 - A61L31/046
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/08 Materials for coatings
• 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: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 25/02 for peripheral neuropathies
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/02 : Nutrients, e.g. vitamins, minerals
• CPC Class Codes: A61P 31/04 : Antibacterial agents
• CPC Class Codes: A61P 31/12 : Antivirals
• CPC Class Codes: A61P 37/08 : Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: A61P 41/00 : Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/02 : Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: A61P 9/10 : for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: A61P 9/12 : Antihypertensives
• CPC Class Codes: Y10T 156/10 : Methods of surface bonding and/or assembly therefor

Abstract

Methods and apparatus for a biodegradable multi-layer device suitable for medical applications are provided, wherein the device is formed from multiple film-layers configured to have different characteristics from one another such as different release profiles for therapeutic agents, adhesive properties, stiffness properties, and solubility properties. The film-layers may include a solid fibrinogen component. A device having multiple film-layers may take a non-adherent form during delivery to a target location within or on tissue, and thereafter may be exposed to moisture to take an adherent form on the tissue. The device may include a number of additives, including materials to improve the mechanical properties of the device, or one or more therapeutic or contrast agents.

Claims

1. A method for applying a device in a sinus of a patient, the method comprising:

advancing the device comprising a first film-layer and a second film-layer to the sinus, the first film-layer comprising fibrinogen and a first therapeutic agent, the second film-layer comprising fibrinogen and a second therapeutic agent;

applying the device on sinus tissue in the sinus;

releasing the first therapeutic agent into the sinus tissue from the first film-layer at a first release profile; and

releasing the second therapeutic agent into the sinus tissue from the second film-layer at a second release profile different from the first release profile; and

wherein the first film-layer is formed by processing a first composition comprising the fibrinogen, the first therapeutic agent, and a first amount of non-aqueous solvent and the second film-layer is formed by processing a second composition comprising the fibrinogen, the second therapeutic agent, and a second amount of non-aqueous solvent different from the first amount of non-aqueous solvent.

2. The method of claim 1, wherein applying the device to the sinus tissue comprises applying the device to the sinus tissue after sinus surgery.

3. The method of claim 1, wherein applying the device to the sinus tissue comprises applying the device to the sinus tissue of the patient suffering from sinusitis.

4. The method of claim 1, wherein the first and second film-layers further comprise calcium salt.

5. The method of claim 4, wherein the calcium salt comprises calcium chloride.

6. The method of claim 1, wherein the first and second film-layers further comprise polyethylene glycol.

7. The method of claim 1, wherein the first film-layer has a first amount of therapeutic agent and the second film-layer has a second amount of the second therapeutic agent different from the first amount.

8. The method of claim 1, wherein the first film-layer and the second film-layer are bonded using an intermediate layer disposed between the first film-layer and the second film-layer.

9. The method of claim 8, wherein the intermediate layer is configured to dissolve to create a reservoir, pores, void, or channel between the first film-layer and the second film-layer.

10. The method of claim 1, wherein the first therapeutic agent or the second therapeutic agent or both comprise one or more 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, RNA, or DNA.

11. The method of claim 1, wherein the first therapeutic agent or the second therapeutic agent or both comprise a steroidal anti-inflammatory agent.

12. The method of claim 1, wherein the first therapeutic agent or the second therapeutic agent or both are fluticasone propionate.

13. The method of claim 1, wherein the first therapeutic agent and the second therapeutic agent are the same type of therapeutic agent.

14. The method of claim 1, wherein the device is configured to form a fibrin patch upon exposure to moisture in the sinus.

15. The method of claim 1, wherein the first film-layer or the second film-layer or both further comprise thrombin mixed with the fibrinogen.

16. The method of claim 1, wherein the first film-layer or the second film-layer or both are coated with a protective layer.

17. The method of claim 1, wherein the first film-layer and the second film-layer are configured to biodegrade within the sinus.

18. The method of claim 1, wherein advancing the device comprises advancing the device using a delivery device, and wherein applying the device to the sinus tissue comprises deploying the device from the delivery device.

19. The method of claim 1, wherein applying the device to the sinus tissue comprises applying the device to the sinus tissue to promote healing of iatrogenic wounds and reduce formation of post-operative lesions.