System for inner ear drug delivery via trans-round window membrane injection

Patent metadata

Field	Value
Publication number	US-2017367892-A1
Application number	US-201715629279-A
Country	US
Kind code	A1
Filing date	Jun 21, 2017
Priority date	Jun 22, 2016
Publication date	Dec 28, 2017
Grant date	—

Abstract

The present disclosure discussed a handpiece for trans-canal delivery of a therapeutic substance to the inner ear. The handpiece can be inserted into the middle ear via a surgical tympanotomy approach. The handpiece can enable a controlled injection of a therapeutic substance directly through the round window membrane and into the inner ear. The direct delivery of the therapeutic substance to the inner ear can enable the delivery of a precise amount of therapeutic substance into the inner ear. Because the therapeutic substance is delivery directly to the inner ear the delivery of the therapeutic substance is not subject to limitations on molecule size and inconsistent diffusion rates that are present when therapeutic substances are diffused across the round window membrane.

First claim

What is claimed:

1 . A handpiece to deliver a fluid to an ear, comprising:
a tool shaft comprising a first distal end, a first proximal end, a first fluidic channel, and a first longitudinal axis; an angled portion comprising a second distal end, a second proximal end coupled with the first distal end, a second fluidic channel in communication with the first fluidic channel, and a second longitudinal axis defining an angle with the first longitudinal axis configured for trans-canal positing of a tip portion at a round window; the tip portion projecting from the angled portion and comprising an outlet and a third fluidic channel in communication with the second fluidic channel; and a collar coupled with the tip portion a predetermined distance from the outlet, the collar configured to seat with the round window and control a distance the tip portion projects into a cochlea.

2 . The handpiece of claim 1 , further comprising a fluid reservoir in communication with the outlet via the first fluidic channel, the second fluidic channel, and the third fluidic channel.

3 . The handpiece of claim 2 , the fluid reservoir further comprising a pierceable septum configured to enable filling of the fluid reservoir.

4 . The handpiece of claim 1 , further comprising:
a fluid reservoir; and a self-contained pumping system coupled with the tool shaft and configured to pump a fluid from the fluid reservoir to the outlet.

5 . The handpiece of claim 1 , wherein the first fluidic channel, the second fluidic channel, and the third fluidic channel form a fluid channel.

6 . The handpiece of claim 1 , wherein the angled portion is configured to detach from the tool shaft.

7 . The handpiece of claim 1 , wherein the angled portion is configured to rotate with respect to the tool shaft.

8 . The handpiece of claim 1 , wherein the tip portion is configured to rotate with respect to the angled portion.

9 . The handpiece of claim 1 , wherein the tip portion is configured to detach from the angled portion.

10 . The handpiece of claim 1 , wherein the collar is substantially dome shaped.

11 . The handpiece of claim 1 , wherein the first fluid channel is encased within the tool shaft, the second fluid channel is encased within the angled portion, and the third fluid channel is encased within the tip portion.

12 . The handpiece of claim 1 , wherein each of the first fluid channel, the second fluid channel, and the third fluid channel are encased in a sterilizable plastic.

13 . The handpiece of claim 1 , wherein the angle is between about 140° and about 170°.

14 . The handpiece of claim 1 , wherein the tip portion projects from the angled portion at an angle between about 75° and about 130°.

15 . The handpiece of claim 1 , wherein the tip portion projects from the angled portion at an angle between about 110° and about 120°.

16 . A method comprising:
providing a handpiece comprising:
a tool shaft comprising a first distal end, a first proximal end, a first fluidic channel, and a first longitudinal axis;
an angled portion comprising a second distal end, a second proximal end coupled with the first distal end, a second fluidic channel in communication with the first fluidic channel, and a second longitudinal axis defining an angle with the first longitudinal axis configured for trans-canal positing of a tip portion at a round window;
the tip portion projecting from the angled portion and comprising an outlet and a third fluidic channel in communication with the second fluidic channel; and
a collar coupled with the tip portion a predetermined distance from the outlet, the collar configured to seat with the round window and control a distance the tip portion projects into a cochlea;
piercing a round window membrane with the tip portion; and flowing a fluid through the outlet and into a cochlea via the first fluidic channel, the second fluidic channel, and the third fluidic channel fluidic channel.

17 . The method of claim 16 , further comprising forming a ventilation hole in the stapes footplate.

18 . The method of claim 16 , further comprising flowing, by a self-contained pumping system coupled with the tool shaft, the fluid from a reservoir.

19 . The method of claim 16 , further comprising seating the collar in the round window.

20 . The method of claim 16 , further comprising setting a rotational offset between the tip portion and the angled portion.

Assignees

• Charles Stark Draper Laboratory Inc
• Mass Eye And Ear Infirmary

Inventors

• Kim Ernest S
• Mckenna Michael
• Kiringoda Ruwan

Classifications

• A61M5/142 Primary

  Pressure infusion, e.g. using pumps · CPC title

• A61M31/00

  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 title

• A61M2210/0662

  Ears · CPC title

• A61F11/00 Primary

  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 title