Cochlear implant drug delivery device

• US 20060287689A1
• Filed: 11/28/2003
• Published: 12/21/2006
• Est. Priority Date: 11/29/2002
• Status: Active Grant

• Current Assignee: Cochlear Limited
• Original Assignee: Cochlear Limited
• Inventors: Debruyne, Kristine, Parker, John, Kaiser, Thomas, Fiedler, Dirk, Milojevic, Dusan, Kloeck, Ben
• Granted Patent: US 8,515,560 B2
• Time in Patent Office: Days
• US Class Current: 607/57
• CPC Class Codes: A61K 9/0046 Ear
• CPC Class Codes: A61L 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 2430/14 for ear reconstruction or ear implants, e.g. implantable hearing aids
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2210/0668 Middle ear
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0541 Cochlear electrodes
• CPC Class Codes: A61P 41/00 Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution

Abstract

Devices for the delivery of a bioactive substance to a cochlea and methods of delivery thereof. The devices include means to allow the release of the bioactive substance within a cochlea.

Claims

1-6. -6. (canceled)

7. An implantable tissue-stimulating device comprising:

a resiliently flexible elongate member having a proximal end and a distal end and at least one electrode mounted thereon between said proximal and distal ends for delivering electrical stimulation; and

a sheath comprised at least in part of a porous material disposed over at least a portion of the elongate member;

wherein at least some of the pores of the sheath have at least one bioactive substance disposed therein prior to implantation, said at least one bioactive substance being adapted to migrate from the pores following implantation of the member.

8-23. -23. (canceled)

25. A drug delivery device comprising:

a resiliently flexible elongate member having a proximal end and a distal end for implantation within the body;

wherein at least a portion of said elongate member is comprised of a biodegradable, biocompatible polymeric material having at least one bioactive substance impregnated therein, said at least one bioactive being adapted to be released upon at least partial degradation of said polymeric material.

26. The drug delivery device of claim 24 wherein the resiliently flexible elongate member forms part of or is used in conjunction with an implantable tissue-stimulating device having at least one electrode mounted thereon.

27. The drug delivery device of claim 26 wherein the implantable tissue-stimulating device comprises a hearing implant electrode assembly.

28-37. -37. (canceled)

38. An implantable tissue-stimulating device comprising:

a lead;

a resiliently flexible elongate member extending from the lead and having a proximal end and a distal end and at least one electrode mounted thereon between said proximal and distal ends for delivering electrical stimulation; and

a bioactive substance delivery means adapted to deliver at least one bioactive substance to the implantee at a location spaced from the distal end of the member during and/or following implantation of the device;

wherein the substance delivery means comprises a body defining a chamber and an outlet in communication with the chamber through which bioactive substance can exit the body and further wherein the body is relatively slidably mounted to the lead of the device.

39. The implantable tissue-stimulating device of claim 38 wherein the device is a hearing implant electrode assembly.

40. The implantable tissue-stimulating device of claim 38 wherein the outlet of the substance delivery means is positionable outside and adjacent the cochleostomy site.

41. The implantable tissue-stimulating device of claim 38 wherein the lead includes a stop means that prevents the body of the substance delivery means slidably moving relatively past the stop means and onto the elongate member.

42. The implantable tissue-stimulating device of claim 38 wherein the body of the substance delivery means comprises an annular member that is positioned around the lead of the stimulating device.

43. The implantable tissue-stimulating device of claim 42 wherein the annular member comprises a first portion and a second portion, the second portion having an outer diameter less than an outer diameter of the first portion.

44. The implantable tissue-stimulating device of claim 38 wherein the outlet of the body is positioned in the distal end of the body and wherein the body includes an inlet in the proximal end of the body such that the inlet and outlet are in communication with each other.

45. The implantable tissue-stimulating device of claim 38 wherein the chamber in the body acts as a reservoir for a bioactive substance and wherein the bioactive substance in the reservoir leaches from the chamber into an implantee.

46. The implantable tissue-stimulating device of claim 38 wherein the outlet includes a semi-permeable membrane.

47. The implantable tissue-stimulating device of claim 44 wherein the inlet of the body is in communication with an additional reservoir for the bioactive substance, said additional reservoir positioned either external or internal the body of the implantee.

48. The implantable tissue-stimulating device of claim 47 wherein a catheter extends from the inlet to the additional reservoir and wherein a pump transfers the bioactive substance from the additional reservoir into the chamber of the body for subsequent delivery to the appropriate site of action.

49. A method of delivering at least one bioactive substance to a desired site of action adjacent a cochleostomy within a patient using a device of claim 38, the method comprising the steps of:

forming a cochleostomy;

inserting the elongate member through the cochleostomy;

closing the cochleostomy; and

slidably positioning the body of the bioactive substance delivery means adjacent the cochleostomy and allowing said at least one bioactive substance to exit therefrom.

50. The implantable tissue-stimulating device of claim 38 wherein the bioactive substance is selected from the group consisting of agents that promote healing, substances that prevent bleeding or at least excessive bleeding, substances that prevent the growth of tissue, including scar tissue, pharmaceutical compounds including anti-inflammatory agents, antibiotics, steroids, substances that assist in reducing the resting potential of neurons, neurotrophic factors including neurotrophins, neuropoietins, insulin-like growth factors, transforming growth factors beta, fibroblast growth factors and other growth factors such as transforming growth factor alpha, platelet-derived growth factor and stem cell factor.