Fluid transfer and diagnostic system for treating the inner ear

• US 6,440,102 B1
• Filed: 07/23/1998
• Issued: 08/27/2002
• Est. Priority Date: 07/23/1998
• Status: Expired due to Fees

• Current Assignee: DURECT Corporation
• Original Assignee: DURECT Corporation
• Inventors: Arenberg, Michael H., Arenberg, Irving K.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): BIANCO, PATRICIA
• Application Number:
  US09/121,460
• Time in Patent Office: 1,496 Days
• Field of Search: 604/96-98, 604/104, 604/20-22, 604/102, 604/110, 604/215, 604/264, 604/523, 604/536-537, 604/506, 604/508-509, 604/173-174, 604/181, 604/271, 604/275, 604/278-279, 606/108-109, 606/191-192, 607/115-16, 607/137, 607/126
• US Class Current: 604/96.01
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61F 11/00 Methods or devices for treatment of the ears or hearing sense implantable prostheses that substitute or replace internal ear parts, e.g. ear-drums, A61F2/18; methods or devices to cause a change in the state of auditory consciousness A61M21/00; electrotherapy applying electrical stimulation of the auditory system, or circuits therefor A61N1/36; radiotherapy using optical stimulation of the auditory system A61N5/06; electro-acoustic hearing aids H04R25/00; Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand headwear, e.g. caps or helmets, with means for protecting the ears A42B1/0188, A42B3/16
• CPC Class Codes: A61N 1/0541 Cochlear electrodes
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis

Abstract

An apparatus for delivering fluid materials into and out of the inner ear via the round window membrane. A fluid transfer conduit is provided which includes one or more passageways therethrough which may have a semipermeable membrane associated therewith to control fluid flow. Attached to the conduit is an inflatable bladder sized for insertion within the round window niche. When inflated, the bladder engages the internal side wall of the niche, thereby securing the bladder and part of the conduit within the niche. The conduit can then transfer fluids to and from the niche and the fluid-permeable round window membrane therein. Bladder inflation may be achieved through one of the passageways within the conduit which can deliver an inflation fluid into the bladder. Also, the conduit may include an elongate conductive diagnostic member for transferring electrical potentials to and from the inner ear.

Claims

1. An inner ear fluid transfer and diagnostic catheter for transferring fluid materials into or out of an ear of a living subject comprising:

a fluid transfer conduit comprising a first end, a second end, and an internal passageway extending through said fluid transfer conduit from said first end to said second end, which fluid transfer conduit permits a fluid to be transferred into or out of an ear; and

an inflatable bladder member connected to said fluid transfer conduit at a position thereon which does not block fluid flow through said fluid transfer conduit, said bladder member being sized for placement of at least a portion thereof within a round window niche of an ear of a subject, wherein said bladder member, when inflated, engages an internal wall of said round window niche thereby maintaining said bladder member at least partially within said round window niche.

2. The apparatus of claim 1 wherein said apparatus further comprises an elongate conductive member operatively connected to said fluid transfer conduit.

12. A method for moving fluid materials through the round window niche and the round window membrane in the ear of a living subject, said method comprising:

inserting the apparatus of claim 1 into an ear of a subject such that said bladder member is positioned at least partially into a round window niche of an ear of said subject;

inflating said bladder member so that said bladder member engages an internal side wall of said round window niche, thereby maintaining said bladder member at least partially within said round window niche; and

transferring fluid materials through said fluid transfer conduit of said apparatus.

13. The method of claim 12 further comprising:

providing an elongate conductive member operatively connected to said fluid transfer conduit; and

placing at least a portion of said elongate conductive member in direct contact with an internal ear component selected from the group consisting of a round window membrane and at least one ear tissue structure adjacent to a round window membrane.

17. A method for moving fluid materials through the round window niche and the round window membrane in the ear of a living subject, said method comprising the steps of:

inflating said bladder member of the apparatus of claim 1;

inserting said bladder member at least partially into a round window niche of a subject after said inflating of said bladder member, said bladder member engaging said internal side wall of said round window niche in order to maintain said bladder member at least partially within said round window niche; and

transferring fluid materials through said fluid transfer conduit.

3. An inner ear fluid transfer and diagnostic catheter for transferring fluid materials into or out of an ear of a living subject comprising:

a fluid transfer conduit comprising a first end, a second end, and at least one internal passageway extending through said fluid transfer conduit from said first end to said second end, which fluid transfer conduit permits a fluid to be transferred into or out of an ear; and

an inflatable annular bladder member connected to said fluid transfer conduit at a position thereon which does not block fluid flow through said fluid transfer conduit, said annular bladder member completely encircling said portion of said fluid transfer conduit and being sized for placement of at least a portion thereof within a round window niche of an ear of a subject, wherein said annular bladder member, when inflated, engages an internal side wall of said round window niche thereby forming a fluid-receiving zone between said annular bladder member and said round window membrane of said ear.

4. The apparatus of claim 3 wherein said apparatus further comprises an elongate conductive member operatively connected to said fluid transfer conduit.

5. The apparatus of claim 3, wherein said fluid-receiving zone is sealed.

14. A method for moving fluid materials through the round window niche and the round window membrane in the ear of a living subject, said method comprising:

inserting the apparatus of claim 3 into an ear of a subject such that said annular bladder member at least partially into a round window niche of said subject;

inflating said annular bladder member so that said bladder member engages said internal side wall of said round window niche, thereby maintaining said bladder member at least partially within said round window niche and to likewise create a fluid-receiving zone between said annular bladder member and said round window membrane; and

transferring fluid materials through said fluid transfer conduit of said apparatus.

15. The method of claim 14 further comprising:

providing an elongate conductive member operatively connected to said fluid transfer conduit; and

placing at least a portion of said elongate conductive member in direct contact with an internal ear component selected from the group consisting of a round window membrane and at least one ear tissue structure adjacent to a round window membrane.

16. The method of claim 14, wherein the fluid-receiving zoned is sealed.

6. An inner ear fluid transfer and diagnostic catheter for transferring fluid materials into or out of an ear of a living subject comprising:

a fluid transfer conduit comprising a first end, a second end, and a plurality of internal passageways extending through said fluid transfer conduit from said first end to said second end, each of said internal passageways being separate from each other within said fluid transfer conduit, which fluid transfer conduit permits a fluid to be transferred into or out of an ear; and

an inflatable bladder member connected to at least a portion of said fluid transfer conduit at a position thereon which does not block fluid flow through said fluid transfer conduit, said bladder member being sized for placement of at least a portion thereof within a round window niche of an ear of a subject, wherein said bladder member, when inflated, maintains said bladder member at least partially within said round window niche, said bladder member being in fluid communication with at least one of said passageways through said fluid transfer conduit in order to allow an inflation fluid to be delivered to said bladder member through said one of said passageways so that said bladder member can be inflated.

7. The apparatus of claim 6 wherein said apparatus further comprises an elongate conductive member operatively connected to said fluid transfer conduit.

8. A medical treatment apparatus for transferring fluid materials into and out of the inner ear of a living subject through the round window niche and the round window membrane of said subject comprising:

a fluid transfer conduit comprising a first end, a second end, at least one internal passageway extending through said fluid transfer conduit from said first end to said second end, and a semi-permeable membrane operatively attached to said fluid transfer conduit at a position which will enable said membrane to at least partially block said passageway so that said fluid materials to be transferred through said passageway will first need to pass through said membrane; and

an inflatable bladder member operatively connected to at least a portion of said fluid transfer conduit at a position thereon which allows said fluid materials to pass into and out of said apparatus, said bladder member being sized for placement within said round window niche of said subject, said round window niche comprising an internal side wall therein which is engaged by said bladder member when said bladder member is inflated in order to maintain said bladder member at least partially within said round window niche.

9. The apparatus of claim 8 wherein said apparatus further comprises an elongate conductive member operatively connected to said fluid transfer conduit.

10. An inner ear fluid transfer and diagnostic catheter for transferring materials into or out of an ear of a living subject comprising:

a fluid transfer conduit comprising a first end, a second end, and at least one internal passageway extending through said fluid transfer conduit from said first end to said second end, which fluid transfer conduit permits a fluid to be transferred into or out of an ear; and

an inflatable bladder member connected to at least a portion of said fluid transfer conduit at a position thereon which does not block fluid flow through said fluid transfer conduit, said bladder member being sized for placement of at least a portion thereof within at least one internal cavity in an ear of a subject, said bladder member being engaged within said internal cavity when said bladder member is inflated in order to maintain said bladder member at least partially within said internal cavity.

11. The apparatus of claim 10 wherein said apparatus further comprises an elongate conductive member operatively connected to said fluid transfer conduit.

20. An inner ear fluid transfer and diagnostic catheter for transferring fluid materials into or out of an ear of a living subject comprising:

(a) a fluid transfer conduit comprising a first end, a second end, and an internal passageway extending through said fluid transfer conduit from said first end to said second end, which fluid transfer conduit permits a fluid to be transferred into or out of an ear; and

(b) an inflatable bladder member connected to said fluid transfer conduit at a position thereon which does not block fluid flow through said fluid transfer conduit, said bladder member being sized for placement of at least a portion thereof within an internal cavity of an ear of a subject, wherein said bladder member, when inflated, engages an internal wall of said internal cavity, thereby maintaining said bladder member at least partially within said internal cavity.

18. A method for moving fluid materials through an internal cavity within an ear of a living subject, said method comprising:

inserting the apparatus of claim 20 into an ear of a subject such that said bladder member is positioned at least partially into an internal cavity in said ear of said subject; and

inflating said bladder member so that said bladder member is at least partially engaged and maintained within said internal cavity.

19. A method for moving fluid materials through an internal cavity within an ear of a living subject, said method comprising:

inflating the bladder member of the apparatus of claim 20; and

inserting said bladder member at least partially into an internal cavity in an ear of a subject after said inflating of said bladder member so that said bladder member is at least partially engaged and maintained within said internal cavity.