Adapter for attaching electromagnetic image guidance components to a medical device

• US 9,198,736 B2
• Filed: 04/19/2012
• Issued: 12/01/2015
• Est. Priority Date: 05/17/2006
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Kim, Isaac J., Goldfarb, Eric, Muni, Ketan P., Makower, Joshua, Deckman, Robert K.
• Primary Examiner(s): Luong, Peter
• Application Number:
  US13/451,020
• Publication Number:
  US 20120245456A1
• Time in Patent Office: 1,321 Days
• Field of Search: 600/424
• US Class Current: 1/1
• CPC Class Codes: A61B 1/313 for introducing through surgical openings, e.g. laparoscopes
• 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 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/3407 including a base for support on the body
• CPC Class Codes: A61B 2017/3486 Balloon
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/3958 emitting a signal
• CPC Class Codes: A61B 2090/397 electromagnetic other than visible, e.g. microwave
• CPC Class Codes: A61B 2090/3975 active
• CPC Class Codes: A61B 2090/3983 Reference marker arrangements for use with image guided surgery
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/485 involving fluorescence X-ray imaging
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61B 90/50 Supports for surgical instruments, e.g. articulated arms
• CPC Class Codes: A61B 90/94 coded with symbols, e.g. text

Abstract

Devices and methods wherein an adapter is used to attach an electromagnetic image guidance component to a medical device such that an electromagnetic image guidance system may be used to track the location of the medical device within the body of a human or animal subject.

Claims

1. An adapter device useable for attaching an electromagnetic image guidance element to a medical device, a distal portion of said medical device being insertable into the body of a human or animal subject during performance of the procedure and a proximal portion of said medical device remaining outside of the subject'"'"'s body during performance of that procedure, said adapter device comprising:

(a) a body portion;

(b) a medical device holding portion having a longitudinal axis, wherein the medical device holding portion is configured to firmly hold the proximal portion of the medical device relative to the longitudinal axis, wherein the medical device holding portion defines a longitudinal plane which extends along the longitudinal axis, wherein the medical device holding portion includes a fixed channel member unitarily coupled to the body portion; and

(c) an element holding portion comprising;

(i) a distal end,

(ii) a proximal end, and

(iii) a clamp coupled to the body, wherein the clamp is partially located between the distal end of the element holding portion and the proximal end of the element holding portion,

wherein the clamp is configured to directly hold the image guidance element firmly in a substantially fixed spatial relation to at least one location of the medical device while allowing a portion of the medical device to be inserted into the subject'"'"'s body for purposes of the procedure.

2. A device according to claim 1 wherein the medical device holding portion comprises a clamping apparatus that engages the proximal portion of the medical device.

3. A device according to claim 2 wherein the clamping apparatus that engages the proximal portion of the medical device comprises a channel through which an elongate medical device may be inserted and apparatus for tightening about the medical device within said channel such that the medical device is held in a fixed position relative to said adapter device.

4. A device according to claim 3 wherein the clamping apparatus comprises first and second clamping components between which the proximal portion of the medical device is positionable and tightening apparatus useable to cause the first and second clamping components to tighten upon and hold the proximal portion of the medical device therebetween.

5. A device according to claim 1 wherein the medical device holding portion comprises a connector configured to mate with a connector on the proximal end of the medical device.

6. A device according to claim 5 wherein the connector of the medical device holding portion comprises a male Luer connector.

7. A device according to claim 6, further comprising a medical device, wherein the medical device has a proximal end, wherein the proximal end of the medical device has a connector, wherein the medical device holding portion further comprises a support member that supports the medical device at a location distal to the connector on the proximal end of the medical device.

8. A device according to claim 7 wherein the support member comprises a gripping portion which grips the medical device at a location distal to the connector on the proximal end of the medical device.

9. A device according to claim 8 wherein the gripping portion-is designed such that the medical device will snap fit therein.

10. A device according to claim 1 wherein the medical device holding portion also prevents the medical device from undergoing substantial rotation.

11. A device according to claim 1 wherein the medical device-holding portion has radial apertures, wherein the radial apertures are configured to receive radial projections on the medical device, wherein the radial apertures are configured to prevent the medical device from undergoing substantial rotation.

12. A device according to claim 1 further comprising indicia indicating information about the type of adapter device being used or the type of medical device that the medical device holding portion is configured to receive, the indicia being readable by an image guidance system when the image guidance element is positioned in the element holding portion.

13. A device according to claim 12 wherein said indicia comprise magnets that produce a magnetic field which identifies the spatial relationship that will exist between sensor(s) of the image guidance element positioned in the element holding portion and a selected location on a medical device to which the adapter device is attached by way of the medical device holding portion.

14. A device according to claim 1 wherein the clamp of the element holding portion is distal in relation to the medical device holding portion.

15. A device according to claim 1 wherein the medical device holding portion and the element holding portion are designed to hold the medical device at an angle relative to the element.

16. A system according to claim 15 wherein the angle is in the range of about 0 to about 45 degrees.

17. A system according to claim 16 wherein the angle is about 20 degrees.

18. A system according to claim 16 further comprising an endoscope useable to visualize the positioning of at least one portion of the medical device within the patient'"'"'s body.

19. A system according to claim 16 further comprising a fluoroscope useable to identify the position of at least one portion of the medical device within the patient'"'"'s body.

20. A system comprising an adapter device according to claim 1 further in combination with an image guidance element that may be attached to the adapter device by way of the element holding portion.

21. A system comprising an adapter device according to claim 1 further in combination with a medical device which may be attached to the adapter device by way of the medical device holding portion.

22. A system according to claim 21 wherein the medical device is a guide catheter.

23. A system according to claim 21 wherein the medical device is a stiff member having a dilatation balloon at the distal portion.

24. A system comprising an adapter device according to claim 1 further in combination with a) a medical device that may be attached to the adapter device by way of the medical device holding portion and b) an image guidance element that may be attached to the adapter device by way of the element holding portion.

25. A system according to claim 24 wherein the medical device has a trackable location on the portion of the medical device that is inserted into the subject'"'"'s body and wherein the adapter device further comprises indicia that indicates the spatial position of the trackable location relative to one or more sensor(s) incorporated in the element.

26. A system for guiding the advancement of a device within the body of a patient comprising:

(a) a guide structure dimensioned to allow advancement of the device into the body, the guide structure comprising a distal exit portion oriented to an angle between zero and 180 degrees relative to an axis of the guide structure and a proximal portion having a radially nonuniform feature oriented in a fixed relationship with respect to the angle of distal exit portion;

(b) an adapter device capable of releasably attaching to the guide structure, wherein the adapter device comprises a clamp, wherein the clamp defines an aperture;

(c) a navigation element confined within the clamp of the adapter device, wherein the navigation element is capable of being detected by a computer-based navigation system, the navigation element housed within the aperture of the clamp during use; and

(d) a medical device positioned in the guide structure and advanceable along the guide structure.

27. A guide system comprising:

(a) an adapter body, wherein the adapter body further defines a guide catheter channel, wherein the guide catheter channel extends through the adapter body in a radially nonuniform manner wherein the adapter body comprises a clamp, wherein the clamp defines an aperture;

(b) an image guidance element operably configured for detection by a computer-based navigation system, wherein the clamp is configured to receive the image guidance element; and

(c) a medical device configured to fit in the guide catheter channel and be advanced along the guide catheter channel.