SELF-EXPANDING DEVICES AND METHODS THEREFOR

• US 20090177272A1
• Filed: 12/12/2008
• Published: 07/09/2009
• Est. Priority Date: 12/18/2007
• Status: Active Grant

• Current Assignee: Intersect ENT, Inc. (Medtronic Plc)
• Original Assignee: Intersect ENT, Inc. (Medtronic Plc)
• Inventors: ABBATE, Anthony 'J., Gale, David C., Huang, Bin, Zaler, Gail M., Kaufman, Richard E.
• Granted Patent: US 8,585,731 B2
• Time in Patent Office: Days
• US Class Current: 623/1.420
• 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 self-expanding device having a first compressed configuration enabling low profile delivery through a delivery device, and a second expanded configuration for apposition against a tissue wall, wherein the device has a geometry facilitating conformation against an irregular tissue wall, and wherein the device defines a lumen in its expanded configuration, the lumen sized to promote clearance of one or more fluids or bodily excretions therethrough.

2. The device of claim 1 wherein at least a portion of the device comprises a biodegradable material.

3. The device of claim 2, wherein the biodegradable material is at least partially coated with a drug, at least partially impregnated with a drug, or comprises one or more drug depots.

4. The device of claim 3 wherein the biodegradable material is at least partially coated with at least one drug eluting layer.

5. The device of claim 3 wherein the drug comprises a drug 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, a hemostatic agent, and combinations and mixtures thereof.

6. The device of claim 5 wherein the drug is an anti-inflammatory agent.

7. The device of claim 6 wherein the drug is mometasone furoate.

8. The device of claim 3, wherein the biodegradable material is at least partially coated with two drugs or at least partially impregnated with two drugs.

9. The device of claim 4, wherein the biodegradable material is at least partially coated with at least two drug eluting layers.

10. The device of claim 9, wherein the at least two drug eluting layers are configured to elute at least two different drugs therefrom.

11. The device of claim 10, wherein the at least two different drugs are configured to elute from the at least two drug eluting layers at different rates.

12. The device of claim 1, wherein the lumen has a generally circular cross-sectional geometry.

13. The device of claim 1, wherein the lumen has a generally rectangular cross-sectional geometry.

14. The device of claim 1, wherein the lumen has a generally elliptical cross-sectional geometry.

15. The device of claim 1, wherein the device has a generally tubular shape.

16. The device of claim 15, wherein the device is formed from a slotted tube.

17. The device of claim 1 having a size and configuration adapted for implantation within one or more sinus regions, sinus cavities, or ostiums thereof.

18. The device of claim 1 having a size and configuration adapted for implantation within an ear, or region thereof.

19. The device of claim 1 having a size and configuration adapted for implantation within a throat.

20. The device of claim 1 having a size and configuration adapted for implantation within an organ or passageway of the excretory system.

21. The device of claim 1 having a size and configuration adapted for implantation within the vasculature.

22. The device of claim 1 having a size and configuration adapted for implantation within a biliary duct.

23. The device of claim 1, wherein the device has an adjustable length.

24. The device of claim 1, wherein the device is modular.

25. The device of claim 1, the lumen defines a normalized diameter, and the normalized diameter is variable along the length of the device.

26. The device of claim 1, wherein the device comprises at least two discrete patterns.

27. The device of claim 1, wherein the overall geometry of the device approximates an hourglass-shape.

28. The device of claim 1 comprising at least one polymer filament formed into a shape having a series of peaks and valleys.

29. The device of claim 28, wherein at least one of the peaks and valleys has a loop at an end thereof.

30. The device of claim 29, 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.

31. The device of claim 29, wherein the loop comprises an eyelet for passage of a suture therethrough.

32. The device of claim 28, wherein the shape approximates a repeating diamond-shaped pattern.

33. The device of claim 28, wherein the shape approximates a repeating arrowhead-shaped pattern.

34. The device of claim 28, wherein the device comprises at least one junction.

35. The device of claim 1 comprising at least one polymer filament formed into a shape having at least two series of peaks and at least one series of valleys.

36. The device of claim 1 comprising at least one polymer filament formed into at least two shapes, each having at least one series of peaks and valleys.

37. The device of claim 36, further comprising one or more junctions.

38. 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 defining a lumen therethrough;

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

performing one or more procedures through the lumen.

39. The method of claim 38, 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.

40. The method of claim 38, wherein the device is advanced adjacent to the sinus cavity in a compressed configuration.

75. The method of any of claims 38, 41, 59, or 74, wherein the one or more sinus cavities are one or more sinus cavities of a pediatric patient.

41. 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 has a geometry facilitating conformation against an irregular tissue wall and wherein the device defines a lumen in its expanded configuration, the lumen sized to promote clearance of one or more fluids therethrough; and

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

42. The method of claim 41 further comprising irrigating the cavity through the lumen.

43. A biodegradable expandable device having an unexpanded configuration and an expanded configuration, wherein the device comprises at least two component pieces, and wherein the at least two component pieces are formed into a shape having a series of peaks and valleys.

44. The device of claim 43, wherein the at least two component pieces are joined together.

45. The device of claim 44, wherein the at least two component pieces are joined together using welding, adhesives, polymers, sutures, clamps, clips, or a combination thereof.

46. The device of claim 44, wherein the at least two component pieces are joined together by intervweaving portions of the at least two component pieces.

47. The device of claim 43, wherein the at least two component pieces comprise at least two separate expandable devices.

48. The device of claim 43, wherein the device is modular.

49. The device of claim 43, wherein at least a portion of the device has a drug coated thereon or impregnated therein.

50. The device of claim 49, wherein at least a portion of the device comprises a drug eluting layer.

51. The device of claim 50, wherein the drug eluting layer comprises a drug 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.

52. The device of claim 51, wherein the drug is an anti-inflammatory agent.

53. The device of claim 52, wherein the drug is mometasone furoate.

54. The device of claim 53 having a size and configuration adapted for implantation within one or more sinus cavities or ostiums thereof.

55. The device of claim 53, wherein at least one of the peaks and valleys has a loop at an end thereof.

56. The device of claim 53, wherein the device has a shape that approximates a repeating diamond-shaped pattern.

57. The device of claim 53, wherein the device has a shape that approximates a repeating arrowhead-shaped pattern.

58. The device of claim 53, wherein the device is self-expanding.

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

advancing a device adjacent to a sinus cavity, wherein the device has an unexpanded configuration and an expanded configuration, wherein the device comprises at least two component pieces, and wherein the at least two component pieces are formed into a shape having a series of peaks and valleys; and

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

60. A self-expanding biodegradable device having a size and configuration adapted for implantation within one or more sinus cavities or ostiums thereof, wherein the device comprises at least two polymer filaments and has a shape that approximates a repeating diamond-shaped pattern, the diamond-shaped pattern defined by a series of repeating peaks and valleys.

61. The device of claim 60, wherein the device comprises at least two component devices.

62. The device of claim 60, wherein the device comprises poly(lactic acid-co-glycolic acid).

63. The device of claim 60, wherein the device comprises junctions.

64. The device of claim 63, wherein the junctions comprise one or more loops.

65. The device of claim 60, wherein at least a portion of the device is coated or impregnated with a drug.

66. The device of claim 65, wherein the drug comprises a drug 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, a hemostatic agent, and combinations and mixtures thereof.

67. The device of claim 66, wherein the drug is an anti-inflammatory agent.

68. The device of claim 67, wherein the drug is mometasone furoate.

69. The device of claim 60, wherein at least one of the peaks and valleys has a loop at an end thereof.

70. The device of claim 69, wherein the loop is coated or impregnated with a polymer for delivery of a drug therefrom.

71. The device of claim 69, 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.

72. The device of claim 69, wherein the loop comprises an eyelet for passage of a suture therethrough.

73. The device of claim 72, further comprising a suture passing through the eyelet whereby the suture is configured to reduce the profile of the device when the suture is pulled.

74. 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 at least two polymer filaments and has a shape that approximates a repeating diamond-shaped pattern, the diamond-shaped pattern defined by a series of repeating peaks and valleys; and

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