TYMPANOSTOMY TUBE DELIVERY DEVICE WITH CUTTER FORCE CLUTCH

• US 20180116876A1
• Filed: 12/04/2017
• Published: 05/03/2018
• Est. Priority Date: 08/12/2014
• Status: Active Grant

• Current Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Original Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Inventors: CLOPP, Mathew D.
• Granted Patent: US 10,736,785 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• 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 2017/00367 Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00787 Surgery of the ear
• CPC Class Codes: A61B 2090/038 during shipment
• CPC Class Codes: A61F 11/202 Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor

Abstract

A tympanostomy tube delivery device comprises a drive assembly and a force limiting shaft assembly. The shaft assembly comprises a cannula and a piercer operable to translate relative to the cannula so as to pierce the tympanic membrane of a patient. The piercer is mechanically coupled with the drive assembly such that actuation of the drive assembly causes translation of the piercer relative to the cannula. The piercer is mechanically coupled with the drive assembly by a clutch. The clutch is resiliently biased to couple the piercer with the drive assembly. The clutch is configured to uncouple the piercer from the drive assembly in response to a threshold force being imposed upon the piercer so as to inhibit translation of piercer relative to the cannula.

Claims

1. (canceled)

2. An apparatus, comprising:

a piercing element;

a clutch;

a driver releasably coupled to the piercing element via the clutch and configured to drive the piercing element; and

a drive assembly coupled to the driver and configured to move the driver to drive the piercing element,

the clutch configured to decouple the driver from the piercing element such that the driver can move in a distal direction relative to the piercing element,

the clutch further configured to couple the driver to the piercing element, after decoupling the driver from the piercing element, when the driver moves in a proximal direction.

3. The apparatus of claim 2, wherein the clutch decouples the driver from the piercing element in response to a force greater than a threshold force acting on the piercing element.

4. The apparatus of claim 2, wherein the clutch includes a flexible portion bendable between a first configuration in which the flexible portion is engaged with a portion of the piercing element and the driver is coupled to the piercing element and a second configuration in which the flexible portion is disengaged from the portion of the piercing element and the driver is decoupled from the piercing element.

5. The apparatus of claim 4, wherein the flexible portion is biased to the first configuration.

6. The apparatus of claim 4, wherein the flexible portion is a first flexible portion and the first flexible portion is configured to engage the piercing element at a first location, the clutch further including a second flexible portion, the second flexible portion configured to engage the piercing element at a second location spaced from the first location.

7. The apparatus of claim 2, wherein the piercing element includes:

a first cylindrical portion having a first diameter;

a second cylindrical portion having a second diameter larger than the first diameter; and

a transition portion connecting the first cylindrical portion to the second cylindrical portion,

the clutch configured to engage at least one of the first cylindrical portion and the transition portion when the driver is coupled to the piercing element.

8. The apparatus of claim 7, wherein the clutch extends a length of the first cylindrical portion.

9. The apparatus of claim 2, wherein the driver is a cam follower,

the cam follower releasably coupled to the piercing element via the clutch,

the drive assembly including a cam engaged with the cam follower and configured to rotate to move the cam follower.

10. The apparatus of claim 9, wherein the clutch is fixed to the cam follower and releasably engaged with the piercing element.

11. The apparatus of claim 9, wherein the clutch is disposed within a bore defined by the cam follower.

12. An apparatus, comprising:

a piercing element;

a clutch; and

a cam follower releasably coupled to the piercing element via the clutch,

the cam follower engageable with a cam, the cam configured to move the cam follower to drive the piercing element,

the clutch configured to decouple the cam follower from the piercing element in response to a force greater than a threshold force acting on the piercing element.

13. The apparatus of claim 12, wherein the cam follower defines a bore and the clutch is disposed within the bore.

14. The apparatus of claim 12, wherein the clutch is fixed to the cam follower and releasably engaged with the piercing element.

15. The apparatus of claim 12, wherein the clutch includes a flexible portion bendable between a first configuration in which the flexible portion is engaged with a portion of the piercing element and the cam follower is coupled to the piercing element and a second configuration in which the flexible portion is disengaged from the portion of the piercing element and the cam follower is decoupled from the piercing element.

16. The apparatus of claim 12, wherein the piercing element includes:

a first cylindrical portion having a first diameter;

a second cylindrical portion having a second diameter larger than the first diameter; and

a transition portion connecting the first cylindrical portion to the second cylindrical portion,

the clutch configured to engage at least one of the first cylindrical portion and the transition portion when the cam follower is coupled to the piercing element.

17. A method, comprising:

positioning an apparatus proximate to a tympanic membrane of a patient, the apparatus including (i) a piercing element configured to form an incision in a tympanic membrane and (ii) a driver releasably coupled to the piercing element via a clutch and configured to move the piercing element;

advancing, using the driver, the piercing element in a distal direction toward the tympanic membrane;

contacting, via the piercing element and in response to advancing the piercing element, a surface other than a surface of the tympanic membrane;

receiving, after contacting the surface, a force greater than a threshold force acting on the piercing element; and

decoupling, in response to receiving the force greater than the threshold force, the driver from the piercing element such that the driver can move in the distal direction relative to the piercing element.

18. The method of claim 17, further comprising:

coupling, after decoupling the driver form the piercing element, the driver to the piercing element when the driver moves in a proximal direction relative to the piercing element; and

retracting, using the driver, the piercing element in the proximal direction.

19. The method of claim 17, further comprising forming, using the piercing element, the incision in the tympanic membrane.

20. The method of claim 17, wherein the clutch includes a flexible portion biased to a first configuration in which the flexible portion is engaged with the piercing element and the driver is coupled to the piercing element,

the receiving the force greater than the threshold force including receiving an amount of force sufficient to overcome a biasing force of the flexible portion such that the flexible portion bends into a second configuration in which the flexible portion is disengaged from the piercing element.

21. The method of claim 17, wherein the surface has a puncture resistance greater than a puncture resistance of the tympanic membrane.