SELF-EXPANDING DEVICES AND METHODS THEREFOR

• US 20090220571A1
• Filed: 12/12/2008
• Published: 09/03/2009
• Est. Priority Date: 12/18/2007
• Status: Active Grant

• Current Assignee: Intersect ENT, Inc. (Medtronic Plc)
• Original Assignee: Intersect ENT, Inc. (Medtronic Plc)
• Inventors: Gale, David C., Huang, Bin, Eaton, Donald J., Abbate, Anthony J., Zaler, Gail M.
• Granted Patent: US 8,585,730 B2
• Time in Patent Office: Days
• US Class Current: 424/426
• 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: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/3454 Details of tips
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/18 Internal ear or nose parts, e.g. ear-drums implants for middle ear ventilation or drainage A61F11/202
• CPC Class Codes: A61F 2/186 Nose parts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9524 Iris-type crimpers
• CPC Class Codes: A61F 2002/048 Ureters
• CPC Class Codes: A61F 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2240/001 : Designing or manufacturing processes
• CPC Class Codes: A61F 2250/003 : differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61F 2250/006 : modular
• CPC Class Codes: A61F 2250/0067 : Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 5/08 : Devices for correcting deformities of the nose ; Devices for enlarging the nostril, e.g. for breathing improvement
• CPC Class Codes: A61K 9/70 : Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug hollow drug-filled fibres A61K9/0092
• CPC Class Codes: A61L 31/022 : Metals or alloys
• CPC Class Codes: A61L 31/10 : Macromolecular materials
• 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 29/00 : Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61P 27/00 : Drugs for disorders of the senses

Abstract

Described here are delivery devices for delivering one or more implants to the body, and methods of using. The delivery devices may deliver implants to a variety of locations within the body, for a number of different uses. In some variations, the delivery devices have a cannula with one or more curved sections. In some variations, a pusher may be used to release one or more implants from the cannula. In some variations, one or more of the released implants may be a self-expanding device. Methods of delivering implants to one or more sinus cavities are also described here.

Claims

1. A self-expanding device having a first compressed configuration enabling low profile delivery through a delivery device, and a second expanded configuration for apposition against tissue, wherein the device comprises either a single continuous filament or at least two non-intersecting filaments, wherein at least a portion of the device comprises a polymer, and wherein the device is capable of biodegrading over a predetermined period of time.

2. The device of claim 1, wherein the device comprises at least one metallic filament.

3. The device of claim 1, wherein the polymer is at least partially coated with a drug eluting layer.

4. The device of claim 3, wherein a drug is configured to be released from the drug eluting layer over a period of time from about 5 to about 120 days.

5. The device of claim 3, wherein the drug eluting layer is discontinuous.

6. The device of claim 3, further comprising a release rate modifier.

7. The device of claim 6, wherein the release rate modifier is a polyethylene glycol.

8. The device of claim 4 wherein the drug is selected from the group consisting of an anti-inflammatory agent, an anti-allergen, an anti-cholinergic agent, an antihistamine, an anti-infective, an anti-platelet agent, an anti-coagulant, an anti-thrombic agent, an anti-scarring agent, an anti-proliferative agent, a chemotherapeutic agent, an anti-neoplastic agent, a decongestant, a vitamin, a hypersomolar agent, an immunomodulator, an immunosuppressive agent, and combinations and mixtures thereof.

9. The device of claim 8 wherein the drug is an anti-inflammatory agent.

10. The device of claim 9 wherein the drug is mometasone furoate.

11. A self-expanding device having a size and configuration adapted for implantation within one or more sinus cavities, wherein the device has a first compressed configuration enabling low profile delivery through a delivery device, and a second expanded configuration for apposition against tissue, wherein the device comprises either a single continuous filament or at least two non-intersecting filaments, wherein at least a portion of the device comprises a polymer, and wherein the device is capable of biodegrading over a predetermined period of time.

12. The device of claim 11, wherein the device has a size and configuration adapted for implantation within a cavity selected from the group consisting of an ethmoid sinus cavity, a maxillary sinus cavity, a frontal sinus cavity, a sphenoid sinus cavity, and combinations thereof.

13. A self-expanding device having a first compressed configuration enabling low profile delivery through a delivery device, and a second expanded configuration for apposition against tissue, wherein at least a portion of the device comprises a biodegradable polymer and formed into a shape having a series of peaks and valleys.

14. The device of claim 13, wherein at least one of the peaks and valleys has a loop at an end thereof.

15. The device of claim 14, wherein the loop is coated or impregnated with a polymer for delivery of a drug therefrom.

16. The device of claim 14, wherein the loop is configured to provide for even distribution of bending stresses applied to the device when the device is placed in its first configuration and loaded into the delivery device.

17. The device of claim 14, wherein the loop comprises an eyelet for passage of a suture therethrough.

18. The device of claim 17, further comprising a suture passing through the eyelet whereby the suture is configured to collapse the device from its second configuration to its first configuration when the suture is pulled.

19. The device of claim 13, wherein the polymer is at least partially coated with a drug eluting layer.

20. The device of claim 19, wherein the polymer and the drug eluting layer comprise PLG, and wherein the polymer and the drug eluting layer have different molar ratios of lactide to glycolide.

21. The device of claim 19, wherein the drug eluting layer comprises mometasone furoate.

22. The device of claim 14, wherein the angle defined by the loop apex is about 30°

to about 150°

when the device is in the radially expanded configuration.

23. A method of treating one or more sinus cavities comprising:

advancing a device adjacent to a sinus cavity, wherein the device comprises a polymer at least partially coated with a drug eluting layer, the device degradable over a predetermined period of time and formed into a shape having a series of peaks and valleys; and

expanding the device at least partially within the sinus cavity.

24. The method of claim 23, wherein the device is advanced adjacent to the sinus cavity in a compressed configuration.

25. The method of claim 23, further comprising crimping the device prior to advancing the device, wherein the ratio of the device prior to crimping and after crimping is in the range of about 1:

2-1;

12.

26. The method of claim 23, wherein at least one of the peaks and valleys have a loop at an end thereof.

27. A method of making a self-expanding device comprising:

extruding a polymer filament, wherein the polymer filament comprises PLG having a molar percent of glycolide from about 70-100% or a molar percent of lactide from about 70-100%;

coating the polymer filament with a drug eluting layer; and

forming the device, wherein the device is crimpable from an expanded configuration to a delivery configuration by at least two-fold.

28. The method of claim 27 further comprising crimping the device.