Self-expanding devices and methods therefor

• US 8,585,731 B2
• Filed: 12/12/2008
• Issued: 11/19/2013
• Est. Priority Date: 12/18/2007
• Status: Active Grant

• Current Assignee: Intersect ENT, Inc. (Medtronic Plc)
• Original Assignee: Intersect ENT, Inc. (Medtronic Plc)
• Inventors: Abbate, Anthony J., Huang, Bin, Zaler, Gail M., Gale, David C., Kaufman, Richard E.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): Price, Nathan R
• Application Number:
  US12/334,382
• Publication Number:
  US 20090177272A1
• Time in Patent Office: 1,803 Days
• Field of Search: 606/199, 604/93.01, 604/93.04, 604/514, 604/516
• US Class Current: 606/199
• 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 self-expanding devices and methods of using and making them. The devices may be useful in a variety of locations within the body, for a number of different uses. In some variations, the devices have a first compressed configuration enabling low profile delivery through a delivery device, a second expanded configuration for apposition against tissue, and comprise either a single continuous filament or at least two non-intersecting filaments. In some variations, the device is formed into a shape having a series of peaks and valleys. At least one of the peaks and valleys may have a loop at then end thereof. At least a portion of these devices may be capable of biodegrading over a predetermined period of time, and the devices may be configured for drug delivery. Methods of treating one or more sinus cavities are also described here.

Claims

1. 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 defining a lumen therethrough, wherein the device comprises a single polymer filament wound into a series of diamond shapes each comprising a peak and a valley, wherein a distal end of the device is defined by the peaks of each of the diamond shapes and a proximal end of the device is defined by the valleys of each of the diamond shapes;

delivering at least a portion of the device within the sinus cavity such that at least a portion of the device expands within the sinus cavity; and

performing one or more procedures through the lumen.

2. The method of claim 1, wherein the procedure is selected from the group consisting of irrigating the sinus cavity, visualizing the sinus cavity, removing an excretion from the sinus cavity, and delivering one or more drugs to the sinus cavity.

3. The method of claim 1, wherein the device is advanced adjacent to the sinus cavity in a compressed configuration.

4. The method of claim 1 wherein the device self-expands within the sinus cavity.

5. The method of claim 1 wherein the device is expanded using an expansion device.

16. The method of any of claim 1, 6, 10, or 13, wherein the one or more sinus cavities are one or more sinus cavities of a pediatric patient.

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

advancing a device adjacent to a sinus cavity, wherein the device has a first compressed configuration enabling low profile delivery, and a second expanded configuration for apposition against a tissue wall, wherein the device comprises a single polymer filament wound into a series of diamond shapes each comprising a peak and a valley, wherein a distal end of the device is defined by the peaks of each of the diamond shapes and a proximal end of the device is defined by the valleys of each of the diamond shapes; and

delivering at least a portion of the device within the sinus cavity such that at least a portion of the device expands within the sinus cavity.

7. The method of claim 6 further comprising irrigating the cavity through the lumen.

8. The method of claim 6 wherein the device self-expands within the sinus cavity.

9. The method of claim 6 wherein the device is expanded using an expansion device.

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

crimping a device from an expanded diameter to a compressed diameter, wherein the ratio of the expanded diameter to the compressed diameter is about 10;

1;

advancing the device adjacent to a sinus cavity, wherein the device comprises a single biodegradable polymer filament wound into a series of diamond shapes each comprising a peak and a valley, wherein a distal end of the device is defined by the peaks of each of the diamond shapes and a proximal end of the device is defined by the valleys of each of the diamond shapes; and

delivering at least a portion of the device within the sinus cavity such that at least a portion of the device expands within the sinus cavity.

11. The method of claim 10 wherein the device self-expands within the sinus cavity.

12. The method of claim 10 wherein the device is expanded using an expansion device.

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

advancing a device adjacent to a sinus cavity, wherein the device has a size and configuration adapted for implantation within one or more sinus cavities or ostiums thereof wherein the device comprises a single polymer filament wound into a series of diamond shapes each comprising a peak and a valley, wherein a distal end of the device is defined by the peaks of each of the diamond shapes and a proximal end of the device is defined by the valleys of each of the diamond shapes, and wherein the polymer filament is wound into a loop at each peak and valley; and

delivering at least a portion of the device within the sinus cavity such that at least a portion of the device expands within the sinus cavity.

14. The method of claim 13 wherein the device self-expands within the sinus cavity.

15. The method of claim 13 wherein the device is expanded using an expansion device.