System and method for treatment of target tissues within the ears

• US 10,258,776 B2
• Filed: 06/25/2018
• Issued: 04/16/2019
• Est. Priority Date: 04/19/2007
• Status: Active Grant

• Current Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Original Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Inventors: Clifford, Anton G., Liu, Greg, Morriss, John H., Makower, Joshua, Facteau, William M., Goldfarb, Eric, Chang, John Y.
• Primary Examiner(s): Orkin, Alexander J
• Application Number:
  US16/017,239
• Publication Number:
  US 20180304059A1
• Time in Patent Office: 295 Days
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/227 for ears, i.e. otoscopes
• CPC Class Codes: A61B 2017/00787 Surgery of the ear
• CPC Class Codes: A61B 5/0077 Devices for viewing the surface of the body, e.g. camera, magnifying lens
• CPC Class Codes: A61F 11/202 Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor
• CPC Class Codes: A61F 2230/0039 H-shaped
• CPC Class Codes: A61F 2230/0052 T-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0082 specially designed for children, e.g. having means for adjusting to their growth
• CPC Class Codes: A61M 2210/0662 Ears
• 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 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body

Abstract

Systems and methods for treating target tissues within the ears are disclosed. Systems include a device including a cutting edge configured to form an incision in a tympanic membrane, a pressure equalization tube positionable within an interior space of the device in a compressed configuration and configured to expand into an expanded configuration when released from the interior space, and an elongate positioning element configured to release the pressure equalization tube from the interior space such that the pressure equalization tube is deployed in the incision formed in the tympanic membrane.

Claims

1. A system, comprising:

a pressure equalization tube including;

a first element disposed at a distal end of the pressure equalization tube;

a second element disposed proximal to the first element and

a tubular portion; and

a pressure equalization tube delivery device including;

an elongate portion defining an interior space, the pressure equalization tube positionable within the interior space in a compressed configuration and configured to expand into an expanded configuration when released from the interior space, the first element of the pressure equalization tube configured to expand radially when the pressure equalization tube is released from the interior space, the first element and the second element of the pressure equalization tube extending radially from the tubular portion when the pressure equalization tube is in the expanded configuration;

a cutting edge disposed at a distal end of the elongate portion and configured to form an incision in a tympanic membrane adjacent to the ear canal; and

an elongate positioning element configured to release the pressure equalization tube from the interior space such that the pressure equalization tube is deployed in the incision formed in the tympanic membrane,

the elongate portion of the pressure equalization tube delivery device having a length of at least 19 millimeters such that the elongate portion can extend through a length of the ear canal to place the cutting edge into contact with the tympanic membrane to form the incision.

2. The system of claim 1, wherein:

the tubular portion extends from the first element of the pressure equalization tube,

the first element of the pressure equalization tube having an outer diameter greater than an outer diameter of the tubular portion when the pressure equalization tube is in the expanded configuration.

3. The system of claim 1, wherein a portion of the pressure equalization tube disposed proximal to the first element and including the second element has a maximum lateral dimension greater than an outer diameter of the tubular portion.

4. The system of claim 1, wherein the elongate positioning element is configured to deploy the pressure equalization tube in the incision such that the first element is disposed distal to the tympanic membrane and the second element is disposed proximal to the tympanic membrane.

5. The system of claim 1, wherein an end of the elongate positioning element is disposable within the interior space adjacent to the pressure equalization tube.

6. The system of claim 1, wherein the elongate portion includes a tapered distal end.

7. The system of claim 1, wherein the elongate portion of the pressure equalization tube delivery device is dimensioned for insertion through a guide device into a region of the ear canal near the tympanic membrane,

the guide device having a length of at least five centimeters,

the length of the elongate portion being greater than a length of the guide device.

8. The system of claim 7, wherein the length of the guide device is at least seven centimeters.

9. The system of claim 1, wherein the elongate portion of the pressure equalization tube delivery device includes a cutting sheath that defines the interior space,

the cutting edge disposed at a distal end of the cutting sheath,

the cutting sheath having a length of at least five centimeters.

10. The system of claim 1, wherein the cutting edge is configured to form a curved incision that mitigates against entry of skin cells of the tympanic membrane into a middle ear space disposed distal to the tympanic membrane.

11. A system, comprising:

a cutting sheath (1) including a cutting edge configured to form an incision in a tympanic membrane and (2) defining an interior space, the cutting sheath having a length of at least 19 millimeters;

a pressure equalization tube defining a through-passage, the pressure equalization tube positionable within the interior space in a compressed configuration in which at least a portion of the through-passage has a reduced diameter; and

an elongate positioning element configured to release the pressure equalization tube from the interior space such that the pressure equalization tube can expand into an expanded configuration and be deployed in the incision formed in the tympanic membrane, the through-passage having a substantially uniform diameter greater than the reduced diameter when the pressure equalization tube is in the expanded configuration.

12. A system, comprising:

a pressure equalization tube defining a through-passage; and

a pressure equalization tube delivery device including;

an elongate portion defining an interior space, the pressure equalization tube positionable within the interior space in a compressed configuration and configured to expand into an expanded configuration when released from the interior space, the through-passage of the pressure equalization tube having a substantially uniform diameter when the pressure equalization tube is in the expanded configuration, the through-passage being compressed and having at least one portion with a reduced diameter when the pressure equalization tube is in the compressed configuration;

a cutting edge disposed at a distal end of the elongate portion and configured to form an incision in a tympanic membrane adjacent to the ear canal; and

an elongate positioning element configured to release the pressure equalization tube from the interior space such that the pressure equalization tube is deployed in the incision formed in the tympanic membrane,

the elongate portion of the pressure equalization tube delivery device having a length of at least 19 millimeters such that the elongate portion can extend through a length of the ear canal to place the cutting edge into contact with the tympanic membrane to form the incision.

13. The system of claim 12, wherein the pressure equalization tube includes a distal portion configured to expand radially when the pressure equalization tube is released from the interior space.

14. The system of claim 13, wherein the pressure equalization tube further includes a tubular portion extending from the distal portion,

the distal portion having an outer diameter greater than an outer diameter of the tubular portion when the pressure equalization tube is in the expanded configuration.

15. The system of claim 14, wherein the pressure equalization tube further includes a portion disposed proximal to the distal portion having a maximum lateral dimension greater than an outer diameter of the tubular portion.

16. The system of claim 12, wherein an end of the elongate positioning element is disposable within the interior space adjacent to the pressure equalization tube.

17. The system of claim 12, wherein the elongate portion includes a tapered distal end.

18. The system of claim 12, wherein the elongate portion of the pressure equalization tube delivery device is dimensioned for insertion through a guide device into a region of the ear canal near the tympanic membrane,

the guide device having a length of at least five centimeters,

the length of the elongate portion being greater than a length of the guide device.

19. The system of claim 18, wherein the length of the guide device is at least seven centimeters.

20. The system of claim 12, wherein the elongate portion of the pressure equalization tube delivery device includes a cutting sheath that defines the interior space,

the cutting edge disposed at a distal end of the cutting sheath,

the cutting sheath having a length of at least five centimeters.

21. The system of claim 12, wherein the cutting edge is configured to form a curved incision that mitigates against entry of skin cells of the tympanic membrane into a middle ear space disposed distal to the tympanic membrane.