Dilation instrument with navigation and distally located force sensor

Patent metadata

Field	Value
Publication number	US-11678940-B2
Application number	US-202017065576-A
Country	US
Kind code	B2
Filing date	Oct 8, 2020
Priority date	Dec 4, 2017
Publication date	Jun 20, 2023
Grant date	Jun 20, 2023

Abstract

A system includes a dilation catheter and a guide member. The dilation catheter includes a proximal end, a distal end, a dilator, a navigation sensor, and a force sensor. The dilator is positioned proximal to the distal end and is configured to transition between a non-dilated configuration and a dilated configuration. The navigation sensor is positioned distal to the dilator and is configured to cooperate with a guidance system and thereby provide signals indicating a position of the dilation catheter in three-dimensional space. The force sensor is positioned distal to the dilator and is configured to provide signals indicating a force encountered by the force sensor. The dilation catheter is configured to slide relative to the guide member. A distal portion of the guide member is sized and configured to fit in a nasal cavity of a patient.

First claim

We claim:

1. An ENT instrument comprising:
(a) a proximal end;
(b) a distal end having a tip;
(c) a navigation sensor positioned proximal to the tip of the distal end, wherein the navigation sensor is configured to cooperate with a guidance system and thereby provide signals indicating a position of the ENT instrument in three-dimensional space, wherein the navigation sensor is spaced apart from the tip of the distal end by a first distance; and
(d) a force sensor positioned proximal to the tip of the distal end, wherein the force sensor is configured to provide signals indicating a force encountered by the force sensor, wherein the force sensor is spaced apart from the tip of the distal end by the first distance.

2. The ENT instrument of claim 1 , wherein the navigation sensor comprises an electromagnetic sensor.

3. A system comprising the ENT instrument of claim 1 , a sensor coupling unit, a computer processor, and a video display monitor.

4. The system of claim 3 , wherein the coupling unit is operable to receive the signals transmitted by the navigation sensor and force sensor, wherein the coupling unit is further operable to communicate the signals from the sensors to the computer processor.

5. The system of claim 4 , wherein the coupling unit is in wired communication with the computer processor.

6. The system of claim 4 , wherein the computer processor is operable to receive the signals transmitted by the coupling unit and convert the signals into data.

7. The system of claim 6 , wherein the video display monitor is operable to graphically display the data converted by the computer processor, wherein the video display is further operable to display an anatomical image of the paranasal sinus.

8. The system of claim 6 , wherein the computer processor is operable to generate at least one of numerical feedback, graphical feedback, or audio feedback.

9. The system of claim 1 , further comprising a balloon dilator positioned near the distal end.

10. A system comprising the ENT instrument of claim 1 and a transmitter, wherein the transmitter is operable to transmit a signal that is sensed by the navigation sensor.

11. The system of claim 10 , wherein the transmitter comprises a generator operable to generate an electromagnetic field.

12. A system comprising the ENT instrument of claim 1 and a guide member, wherein the ENT instrument is configured to slide relative to the guide member, wherein a distal portion of the guide member is sized and configured to fit in a nasal cavity of a patient, wherein the guide member comprises a guide catheter.

13. The system of claim 12 , wherein the guide catheter defines a lumen, wherein the ENT instrument is slidably disposed in the lumen of the guide catheter.

14. The system of claim 13 , further comprising a guidewire, wherein the ENT instrument defines a lumen, wherein the guidewire is slidably disposed in the lumen of the ENT instrument.

15. A system comprising the ENT instrument of claim 1 and a guide member, wherein the ENT instrument is configured to slide relative to the guide member, wherein a distal portion of the guide member is sized and configured to fit in a nasal cavity of a patient, wherein the guide member comprises a guidewire.

16. The system of claim 15 , wherein the guidewire comprises a navigation sensor, wherein the navigation sensor of the guidewire is configured to cooperate with a guidance system and thereby provide signals indicating a position of the guidewire in three-dimensional space.

17. A system comprising:
(a) an ENT instrument, wherein the ENT instrument includes:
a proximal end,
(ii) a distal end having a tip,
(iii) a first sensor positioned proximal to the tip of the distal end and directed toward a first direction distal to the distal end, and
(iv) a second sensor positioned proximal to the tip of the distal end and directed toward the first direction; and

(b) a processor, wherein the processor is configured to determine the position of the ENT instrument in three-dimensional spaced based on a position signal from the first sensor, wherein the processor is further configured to determine a force exerted against the ENT instrument based on a force signal from the second sensor.

18. The system of claim 17 , further comprising at least one electromagnetic field generator, wherein the first sensor is configured to generate the position signal in response to movement of the first sensor within an electromagnetic field generated by the electromagnetic field generator.

19. The system of claim 17 , further comprising a display in communication with the processor, wherein the display is configured to provide visual feedback indicative of the position of the ENT instrument in three-dimensional space, wherein the display is further configured to provide visual feedback indicative of force exerted against the ENT instrument.

20. A method of navigating a medical instrument in a paranasal sinus using a guidance system, the guidance system comprising a navigation sensor, a force sensor, a processor, and a display, the method comprising:
(a) advancing the medical instrument into a nasal cavity of a patient;
(b) observing a position feedback indicator on a display to monitor the location of the medical instrument in the nasal cavity of the patient, wherein the position feedback indicator is rendered based on data from the navigation sensor, wherein the position feedback indicator indicates a first direction in which a distal end of the medical instrument is facing; and
(c) observing a force feedback indicator on a display to monitor forces exerted against the medical instrument in the nasal cavity of the patient, wherein the force feedback indicator is rendered based on data from the force sensor, wherein the force feedback indicator indicates a second direction in which the monitored forces are exerted from.

Assignees

• Acclarent Inc

Inventors

• Salazar Henry F
• Palushi Jetmir
• Smith Jr David A

Classifications

• A61B5/066

  Superposing sensor position on an image of the patient, e.g. obtained by ultrasound or x-ray imaging · CPC title

• A61M2210/0618

  Nose · CPC title

• A61M2205/0216

  Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking · CPC title

• A61B2034/2072

  Reference field transducer attached to an instrument or patient · CPC title

• A61B1/07

  using light-conductive means, e.g. optical fibres · CPC title