Self-expanding devices and methods therefor

• US 10,471,185 B2
• Filed: 06/28/2018
• Issued: 11/12/2019
• Est. Priority Date: 12/18/2007
• Status: Active Grant

• Current Assignee: Intersect ENT, Inc. (Medtronic Plc)
• Original Assignee: Intersect ENT, Inc. (Medtronic Plc)
• Inventors: Eaton, Donald J., Huang, Bin, Abbate, Anthony J., Zaler, Gail M., Gale, David C.
• Primary Examiner(s): Stiles, Amber R
• Application Number:
  US16/021,659
• Publication Number:
  US 20190125935A1
• Time in Patent Office: 502 Days
• 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 method of treating one or more sinus conditions in a patient, the method comprising:

delivering an expandable device to one or more sinus cavities, wherein delivering the expandable device to one or more sinus cavities comprises delivering the expandable device adjacent to one of an ethmoid sinus cavity, a maxillary sinus cavity, a frontal sinus cavity, and a sphenoid sinus cavity,

wherein the expandable device is configured to expand from a first compressed configuration to a second expanded configuration for conformation against sinus tissue, and

wherein the expandable device comprises one or more biodegradable polymer filaments arranged to form a series of diamond shapes, wherein a distal end of the expandable device and a proximal end of the expandable device are defined by each of the diamond shapes.

2. The method of claim 1, wherein the expandable device is self-expanding.

3. The method of claim 1, wherein the expandable device has a compressed diameter in the first compressed configuration and an expanded diameter in the second expanded configuration.

4. The method of claim 3, wherein a ratio of the expanded diameter to the compressed diameter is about 2:

1 to about 20;

1.

5. The method of claim 1, wherein each of the diamond shapes comprises a peak and a valley, wherein the distal end of the expandable device is defined by the peaks of each of the diamond shapes and the proximal end of the expandable device is defined by the valleys of each of the diamond shapes.

6. The method of claim 5, wherein at least one of the one or more biodegradable polymer filaments is wound to form a loop on at least one of the distal end of the expandable device and the proximal end of the expandable device.

7. The method of claim 1, wherein the expandable device is at least partially coated with a drug eluting layer comprising a drug.

8. The method of claim 7, wherein the drug eluting layer comprises a release rate modifier.

9. The method of claim 8, wherein the release rate modifier is polyethylene glycol.

10. The method of claim 7, wherein the drug is an anti-inflammatory agent.

11. The method of claim 7, wherein the drug eluting layer is configured to release the drug at a daily dosage of about 500 μ

g or less per day.

12. The method of claim 7, wherein the drug eluting layer is configured to release the drug over a period of time between about 5 days to about 120 days.

13. The method of claim 10, wherein the drug is mometasone furoate.

14. The method of claim 1, wherein delivering the expandable device comprises advancing the expandable device in the first compressed configuration in a delivery device, and actuating a plunger in the delivery device.

15. The method of claim 1, wherein the one or more biodegradable polymer filaments comprises polyurethane.

16. The method of claim 1, wherein the one or more biodegradable polymer filaments comprises poly(lactide-co-caprolactone).

17. The method of claim 1, wherein the one or more biodegradable polymer filaments comprises poly(lactide-co-glycolide).

18. A method of treating one or more sinus conditions in a patient, the method comprising:

delivering an expandable device to a sinus region, wherein delivering the expandable device comprises delivering the expandable device adjacent to one of an ethmoid sinus cavity, a maxillary sinus cavity, a frontal sinus cavity, and a sphenoid sinus cavity,

wherein the expandable device is configured to expand from a first compressed configuration to a second expanded configuration for conformation against sinus tissue, and

wherein the expandable device comprises at least one biodegradable polymer filament and wherein the expandable device is configured to release mometasone furoate at a daily dosage of about 500 μ

g or less per day.

19. The method of claim 18, wherein the expandable device is configured to release the mometasone furoate over a period of time between about 5 days to about 120 days.

20. The method of claim 19, wherein the expandable device is configured to release the mometasone furoate at a constant rate.

21. The method of claim 18, wherein the expandable device comprises a tube.

22. The method of claim 18, wherein the expandable device comprises at least two biodegradable polymer filaments.

23. The method of claim 18, wherein the at least one biodegradable polymer filament comprises poly(lactide-co-glycolide).

24. The method of claim 23, wherein the molar percent of lactide in the at least one biodegradable polymer filament is between about 0% and about 50%.

25. The method of claim 24, wherein the molar ratio of lactide to glycolide is about 10:

90.

26. The method of claim 18, wherein the at least one biodegradable polymer filament comprises poly(lactide-co-caprolactone).

27. The method of claim 18, wherein the expandable device has a compressed diameter in the first compressed configuration, and an expanded diameter in the second expanded configuration, and wherein a ratio of the expanded diameter to the compressed diameter is about 2:

1 to about 20;

1.

28. A method of treating one or more sinus conditions in a patient, the method comprising:

delivering an expandable device to a sinus region, wherein the expandable device is configured to expand from a first compressed configuration to a second expanded configuration for conformation against sinus tissue,

wherein the expandable device comprises at least one biodegradable polymer filament comprising poly(lactide-co-glycolide) and the molar percent of lactide in the at least one biodegradable polymer filament is between about 0% and about 50%, and

wherein the expandable device is configured to release mometasone furoate at a daily dosage of about 500 μ

g or less per day.

29. The method of claim 28, wherein the expandable device is configured to release mometasone furoate over a period of time between about 5 days to about 120 days.

30. The method of claim 29, wherein the expandable device is configured to release the mometasone furoate at a constant rate.

31. The method of claim 28, wherein the expandable device comprises a tube.

32. The method of claim 28, wherein the expandable device comprises at least two biodegradable polymer filaments.

33. The method of claim 28, wherein the at least one biodegradable polymer filament comprises poly(DL-lactide-co-glycolide).

34. The method of claim 28, wherein the molar ratio of lactide to glycolide is about 10:

90.

35. The method of claim 28, wherein the expandable device has a compressed diameter in the first compressed configuration, and an expanded diameter in the second expanded configuration, and wherein a ratio of the expanded diameter to the compressed diameter is about 2:

1 to about 20;

1.

36. The method of claim 28, wherein delivering the expandable device comprises delivering the expandable device adjacent to one of an ethmoid sinus cavity, a maxillary sinus cavity, a frontal sinus cavity, and a sphenoid sinus cavity.

37. The method of claim 28, wherein delivering the expandable device comprises delivering the expandable device to the osteomeatal complex.