HANDLE FOR STEERABLE CATHETER

Abstract

A handle for controlling a steerable catheter can be aligned so that the direction of movement of the catheter is aligned with the orientation of an image on a monitor. In one embodiment, the handle is axially symmetric, allowing a physician to grasp it such that the movement of the catheter is aligned with an image displayed. In another embodiment, the handle is a grip that is rotatable with respect to the controls of a steerable catheter in order to align the movement with the image displayed.

Description

FIELD OF THE INVENTION

The present invention relates to medical devices in general and to steerable imaging devices in particular.

BACKGROUND OF THE INVENTION

On most handles for a steerable imaging device, the relationship between the handle controls and the motion of the device is fixed. On some devices, however, the “up” direction as viewed on the TV monitor will probably not be the same as the “up” direction on a handle of the device. This occurs when the imaging device can rotate relative to a surrounding catheter or within the patient's body. As a result, the physician must move the controls to the left (for example) in order to steer the catheter in the “up” direction on the TV monitor. If the imaging device rotates again, the physician must re-determine which control direction corresponds to the “up” direction on the screen. This process is not only cumbersome but increases the required time to complete an examination.

SUMMARY OF THE INVENTION

To address the problems discussed above, the present invention is a handle configuration and steering mechanism that can be rotated in the user's hand such that the “up” direction on the handle can always be aligned with the “up” direction of images produced on a screen. The handle may also include a rotating collar or other device to indicate which direction on the handle corresponds to the “up” direction on the screen.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing aspects and many of the attendant advantages of this invention will become more readily appreciated as the same become better understood by reference to the following detailed description, when taken in conjunction with the accompanying drawings, wherein:

FIG. 1 illustrates a conventional 4-wire actuation handle for use in controlling the direction of a steerable catheter;

FIG. 2 is a handle for use with a steerable catheter according to an embodiment of the present invention; and

FIG. 3 is a rotatable grip for use with a steerable catheter in accordance with another embodiment of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

As discussed above, the present invention is a handle that includes a steering mechanism for controlling the direction of a device to be inserted into a patient and that such device either produces images from within the body or whose position is imaged externally, such as by fluoroscopy, ultrasound, etc. The steering mechanism may be formed in a number of ways and be used with a variety of devices. In one embodiment, the steerable device is a multi-lumen catheter having one or more of the lumens dedicated to an imaging fiber and illumination fibers. The imaging and illumination fibers facilitate the transmittal of a visual image from inside the body to a physician or video camera. Alternatively, the catheter may include a solid state imaging sensor, such as a CCD or CMOS imaging chip. Another one or more of the lumens in the catheter are dedicated to pull wires that articulate the distal tip of the catheter. The pull wires have their distal ends secured at or adjacent the distal end of the catheter and their proximal ends connected to an actuator in the steering mechanism. Pulling one of the pull wires causes compression in one side of the catheter at the distal tip, which causes it to bend or articulate in that direction.

Utilizing four pull wires in four lumens allows four-way (left, right, up and down) motion. Some steerable catheters only utilize one pull wire and have only one direction of motion, while others utilize two wires for bi-directional motion. The present invention is most applicable to a four-wire system, but systems with fewer wires can also benefit.

One method of actuating the pull wires is shown in FIG. 1. The steering mechanism includes a handle 20 with four pull wires 22, wherein proximal ends of the four pull wires are connected to the corners of an actuation plate 10. The steering mechanism includes a frame that supports a spherical ball and the attached actuation plate 10 so that the ball 12 can rotate between a front bearing 14 and a rear bearing 16, under direction of a lever arm 18. When the lever arm 18 is moved in a certain direction, the net result is that one or two of the four pull wires 22 are pulled. As is already known to those in the art, the resultant pull on the wires actuates the steerable tip of the catheter. This particular handle 20 is designed so that motion of the distal tip corresponds to the motion of the actuation lever—if the lever is moved down, then the distal tip of the catheter is also moved down.

The problem with the arrangement shown in FIG. 1 is that the handle 20 remains fixed with respect to the orientation of the lever arm 18. If the imaging device becomes rotated with respect to a catheter in which it is placed or the catheter is rotated with respect to a patient, movement of the lever arm in the “up” (or other) direction no longer corresponds to an “upward” (or other) movement of the image on a display. For example, the “up” direction of the visualization probe could be aligned with the “left” direction of the catheter. In this example, when the physician wants to steer the catheter towards the top of the video screen, he must actually move the control lever in a leftward direction. If the handle could be easily re-oriented such that “up” relative to the physician corresponds to “left” relative to the steering controls (which thus corresponded to “up” on the video screen), then the task of steering the tip of the catheter would be greatly simplified.

The present invention is a handle that controls a steerable catheter in a way that allows a user to easily re-orient the steering device such that movement of the pull wires in a direction produces movement of the image produced in a similar direction. Although the invention is described with respect to aligning an upward movement on a display with movement of the steering mechanism in a particular reference direction, it will be appreciated that movement in any direction can form a reference direction.

As shown in FIG. 2, a handle 50 according to one embodiment of the invention contains the same lever arm 18 and catheter steering mechanism as shown in FIG. 1, but has an exterior shape that is basically symmetric about a central axis and can be held in the user's hand in any orientation. The physician can grasp the outer diameter surface of the handle 50 with the palm and fingers in a substantially vertical orientation (like a water glass), then use the thumb to operate the lever arm 18. If the physician discovers (for example) that a leftward motion of the lever arm 18 is needed to create an upward motion of the distal tip, then he could grasp the handle 50 ninety degrees clockwise so that now an upward motion of the lever arm 18 will cause an upward motion of the tip of the catheter.

The handle 50 may also include a rotatable ring 52 that can spin around the handle body, but will remain in place due to friction or other means if it is left alone. This ring 52 could include a visual marker 54 that indicates which direction is “up”. Thus once the physician finds out which direction on the handle 50 corresponds to “up” on the screen, he can rotate the ring 52 such that the visual marker 54 is aligned with the “up” direction. This facilitates keeping the handle 50 aligned in the proper orientation and allows the user to put the handle down and pick it back up again without losing the proper orientation.

One particular application of the handle 50 of the present invention is for use with a fiber optic visualization catheter used in viewing the biliary tract. Such a catheter is normally introduced into the area of the biliary tract via a duodenoscope of the type well known in the art. A further improvement to the above handle would include a means for temporarily fastening the handle that actuates the catheter to the handle of the duodenoscope. Such a fastening means could include a velcro strap, a “C-clamp” and/or some kind of snap-fit component. The fastening means would allow the handle 50 to be rotated and aligned such that motion of the actuation lever could correspond with the motion of a catheter tip. The advantage of such a fastening means is that the physician can more easily operate the duodenoscope, the handle 50, and any auxiliary equipment required for the medical procedure. The physician would be able to release the catheter handle without it dropping towards the floor and without it losing rotational alignment.

In another embodiment, the handle may include an ergonomically shaped exterior grip 70 as shown in FIG. 3. The grip 70 is rotatable around the steering mechanism such that a user can change the orientation of the grip 70 with respect to the lever arm 18 and associated steering mechanism. In use, the grip 70 is rotated so that movement of the lever arm 18 produces images that move in a desired direction on an image display. The grip 70 remains in its orientation by friction or may include a locking mechanism that allows the grip 70 to rotate when released.

As will be appreciated, the present invention enables the physician to always have the correct orientation between what is seen on the TV monitor and what direction to move the controls on the handle.

While the preferred embodiment of the invention has been illustrated and described, it will be appreciated that various changes can be made therein without departing from the scope of the invention. For example, the present invention can be used with any steerable device whose position is displayed on a screen. For example, catheters whose position is determined and displayed to a user using fluoroscopy or ultrasound can use the handle of the present invention in order to align movement of the catheter with a particular direction on the screen. It is therefore intended that the scope of the invention be determined from the following claims and equivalents thereof.

Claims

1-9. (canceled)

10. A steerable medical device, comprising;

an elongated member having a proximal end and a steerable distal end;

a handle coupled to the proximal end of the member, the handle including a proximal end and a distal end, and extending along a longitudinal axis;

a steering actuator configured to deflect the steerable distal end of the member, the actuator extending along a longitudinal actuator axis proximally of the proximal end of the handle and, when in a neutral position, along or parallel with the longitudinal axis of the handle;

a steering arrangement functionally associated with the actuator, wherein movement of the actuator causes deflection of the steerable distal end of the member in one or more directions; and

indicia indicating to a user a direction in which the actuator is to be moved in order to produce movement of the steerable distal end in a desired direction;

wherein the handle is substantially symmetric about the longitudinal axis; and

wherein the actuator is configured to be actuated by a single digit.

11. The steerable medical device of claim 10, wherein the handle and the actuator are configured for one-handed operation.

12. The steerable medical device of claim 10, wherein the actuator is a joy-stick.

13. The steerable medical device of claim 10, wherein the actuator is configured for 360 degree movement.

14. The steerable medical device of claim 10, wherein the indicia is moveable with respect to the handle.

15. The steerable medical device of claim 14, further including:

a ring disposed on and rotatable about the handle, wherein the indicia are associated with the ring such that movement of the ring causes movement of the indicia.

16. The steerable medical device of claim 15, wherein the ring is configured to rotate upon application of a force and remain stationary with respect to the handle when the force is removed.

17. The steerable medical device of claim 10, wherein the indicia includes directional markings.

18. The steerable medical device of claim 10, wherein the handle is rotatable with respect to the member.

19. The steerable medical device of claim 10, further including:

means for fastening the handle to a second medical device, wherein the means includes at least one of a velcro-strap, a C-clamp, a snap-fit component, or combinations thereof.

20. A steerable medical device, comprising:

an elongated member having a proximal end and a steerable distal end;

a handle coupled to the proximal end of the member, the handle including a proximal end and a distal end, and extending along a longitudinal axis;

a steering lever configured to deflect the steerable distal end of the member, the lever extending proximally of the proximal end of the handle and, when in a neutral position, along or parallel with the longitudinal axis, wherein the lever is adapted for 360 degree movement;

two or more pull wires having distal ends secured at or adjacent the steerable distal end of the member and proximal ends functionally associated with the lever, wherein movement of the lever causes at least one of the two or more pull wires to be selectively tensioned or relaxed in order to deflect the distal end of the member in one or more directions: and

indicia indicating to a user a direction in which the lever is to be activated in order to produce movement of the steerable distal end in a desired direction;

wherein at least a portion of the handle is rotatable with respect to, and independently of, the lever.

21. The steerable medical device of claim 20, wherein the indicia is moveable with respect to the handle.

22. The steerable medical device of claim 21, further including:

a ring disposed on and rotatable about the handle, wherein the indicia are associated with the ring such that movement of the ring causes movement of the indicia.

23. The steerable medical device of claim 22, wherein the ring is configured to rotate upon application of a force and remain stationary with respect to the handle when the force is removed.

24. The steerable medical device of claim 20, wherein the handle includes an ergonomic grip configured for selective rotation about the longitudinal axis relative to, and independently of, the lever.

25. A method of orienting a medical device, comprising:

inserting a medical device into a body lumen of a patient, the medical device including: an elongated member having a steerable distal end; and a handle coupled to a proximal end of the member and functionally associated with a steering actuator configured to deflect the steerable distal end of the member, the handle including indicia and the actuator extending proximally of a proximal end of the handle and, when in a neutral position, along or parallel with a longitudinal axis of the handle;

moving the actuator in an upwards direction;

observing which direction the steerable distal end moves in response to the upward movement of the actuator; and

rotating the indicia relative to the handle such that the indicia indicate which direction of deflection corresponds with an upward movement of the actuator.

26. The method of claim 25, wherein the medical device further includes a ring disposed on and rotatable about the handle, wherein the indicia are associated with the ring such that movement of the ring causes movement of the indicia.

27. The method of claim 26, wherein the ring is configured to rotate upon application of a force and remain stationary with respect to the handle when the force is removed.

26. The method of claim 25, further including:

holding the medical device in a single hand.

29. The method of claim 25, wherein moving the actuator includes moving the actuator with a single digit of a user.