Catheter with tactile indication of deflection

Abstract

A catheter with haptic indication of deflection includes a shaft, a control handle having a housing configured with a recess, and a deflection lever mounted on the housing over the recess and configured to deflect the shaft as it rotates. The deflection lever includes a ball bearing and a spring screw configured to move the ball bearing into resilient contact with the groove when the deflection lever is rotated into a neutral position, where engagement between the ball bearing and the groove provides a tactile indication of shaft deflection detected by an operator holding the deflection lever.

Description

Technical Field

[0001] The present invention relates to a catheter having a deflectable shaft, in particular, a catheter having a control handle equipped with a deflection rod. Background Art

[0002] Arrhythmias are irregular beatings of the heart caused by abnormal electrical signals. Arrhythmias can reduce quality of life and increase the risk of stroke and heart failure. Arrhythmias can be located and identified via diagnostic catheters. These catheters can be used to create electroanatomical maps to help electrophysiologists understand lesions and plan and deliver treatments, which may include ablation via therapeutic catheters.

[0003] Conventional electrophysiology (EP) catheters, whether diagnostic or therapeutic, are guided through the patient's blood vessels by an operator manipulating a control handle. The catheter typically has one or more pull wires extending through the catheter shaft between the control handle and the distal actuator end, wherein a mechanism in the control handle acts on the proximal end of the pull wire to achieve deflection of the catheter shaft. The catheter may include a thumb control that slides longitudinally relative to the control handle, typically for unidirectional deflection of the catheter shaft, or the catheter may include a deflection rod that rotates from one side to the other for bidirectional deflection of the catheter shaft. In the latter aspect, the deflection rod has two opposing arms, one on each side of the control handle, and is configured to occupy a "neutral" position in which the catheter shaft is not deflected when the arms extend uniformly on each side of the control handle. With the thumb and index finger located on the respective arms of the deflection rod, the operator can rotate the deflection rod with the thumb or index finger to deflect the catheter shaft in the same direction. Although the deflection rod may have visual markings indicating the direction of rotation, the operator primarily views a 3D graphical anatomical map showing the position of the distal end of the catheter. Furthermore, manipulation of the distal end of the catheter may involve the operator flipping the control handle upside down so that the deflection rod is on the underside of the control handle, not visible, and the direction of deflection is not apparent simply from the feel of the control handle. Thus, despite the presence of visual markings on the deflection rod, the orientation of the deflection rod as an indicator of catheter deflection is not apparent to the operator in the middle of a procedure.

[0004]

[0006] Applicants have therefore recognized that a need exists to provide a deflecting catheter that provides a tactile indication of the orientation of a deflection rod and the deflection state of the catheter shaft. Summary of the invention

[0005] In some embodiments, a catheter with a tactile indication of deflection includes a shaft, a control handle having a housing configured with a groove, and a deflection rod mounted on the housing over the groove and configured to deflect the shaft as the deflection rod is rotated. The deflection rod includes a ball bearing and a spring screw configured to mobilize the ball bearing into resilient contact with the groove when the deflection rod is rotated into a neutral position, such that the resilient contact provides a tactile indication of shaft deflection detected by the deflection rod.

[0006] In some embodiments, the ball bearing has resilient contact with the housing when the deflection rod is rotated away from the neutral position.

[0007] In some embodiments, the groove is aligned with the longitudinal axis of the lever.

[0008] In some embodiments, the deflection rod includes a boss through which the spring screw extends.

[0009] In some embodiments, the spring screw includes a head and an end, the head and the end together defining an axis that is generally perpendicular to the longitudinal axis, and the ball bearing is located between the end and the groove.

[0010] In some embodiments, the catheter includes a control handle including an outer surface having a groove and a deflection rod mounted on the control handle over the groove, the deflection rod being configured to rotate relative to the control handle. The catheter also includes: a ball bearing; a spring screw configured to move the ball bearing into and out of engagement with the groove as the deflection rod rotates; and a shaft located distal to the control handle, the shaft being bidirectionally deflectable in response to the deflection rod.

[0011] In some embodiments, the ball bearing is located between the spring screw and the outer surface, and the spring screw is configured to urge the ball bearing toward the outer surface.

[0012] In some embodiments, the control handle defines a longitudinal axis, and the deflection rod is configured to rotate about an axis perpendicular to the longitudinal axis.

[0013] In some embodiments, the deflection rod is configured with a boss through which the spring screw extends.

[0014] In some embodiments, the deflection rod has a first arm with a tactilely smooth surface and a second arm with a tactilely ridged surface.

[0015] In some embodiments, when the ball bearing is engaged with the groove, the deflection rod is in a neutral position.

[0016] In some embodiments, the deflection rod is in a rotated position when the ball bearing is not engaged with the groove.

[0017] In some embodiments, when the deflection lever is in a neutral position, the shaft does not deflect.

[0018] In some embodiments, when the deflection rod is in a rotated position, the shaft deflects.

[0019] In some embodiments, the catheter includes a control handle that defines a longitudinal bisector axis and includes an outer surface having a groove aligned with the longitudinal bisector axis. The catheter also includes a deflection rod mounted on the control handle and configured to rotate bidirectionally relative to the longitudinal bisector axis about a rotation axis perpendicular to the longitudinal bisector axis, wherein the groove defines a neutral position for bidirectional rotation of the deflection rod. The catheter also includes a spring screw fixed to the rod, the spring screw including a ball bearing configured to move into and out of the groove as the deflection rod rotates; and a shaft located distal to the control handle and bidirectionally deflecting in response to the deflection rod.

[0020] In some embodiments, this bidirectional deflection of the shaft includes a larger deflection in one direction and a smaller deflection in the opposite direction.

[0021] In some embodiments, the larger deflection is about 180 degrees and the smaller direction is about 90 degrees.

[0022] In some embodiments, the deflection rod has one arm on one side of the longitudinal bisecting axis and another arm on an opposite side of the longitudinal bisecting axis.

[0023] In some embodiments, the deflection rod includes one arm having a tactilely uneven surface and another arm having a tactilely smooth surface.

[0024] In some embodiments, the deflection rod includes a boss through which the spring screw extends.

[0025] In some embodiments, the boss is parallel to the axis of rotation.

[0026] In some embodiments, the boss is perpendicular to the longitudinal bisecting axis.

[0027] In some embodiments, the boss is aligned with the bisecting axis of the deflection rod.

[0028] In some embodiments, when the deflection rod is in the neutral position, the bisecting axis of the deflection rod is aligned with the longitudinal bisecting axis of the control handle.

[0029] In some embodiments, the catheter includes a friction inducing washer located between the deflection rod and the outer surface.

[0030] In some embodiments, the catheter includes a visual indicator on the deflection rod that aligns with the spring screw. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] These and other features and advantages of the present invention will be better understood by referring to the following detailed description when considered in conjunction with the accompanying drawings. It should be understood that selected structures and features are not shown in certain drawings in order to provide a better view of the remaining structures and features.

[0032] Figure 1 is a perspective view of a catheter with tactile deflection indication according to an embodiment.

[0033] Figure 2 is a perspective view of a control handle according to an embodiment.

[0034] Figure 3 is a top perspective view of a housing of a control handle according to an embodiment.

[0035] Figure 4A , Figure 4B and Figure 4C yes Figure 1 A top plan view of a catheter of the present invention, wherein the deflection rod of the control handle is in a neutral position, a position with less deflection, and a position with more deflection, respectively.

[0036] Figure 5A is a top perspective view of a deflection rod according to an embodiment.

[0037] Figure 5B for Figure 5A Bottom perspective view of the deflection rod.

[0038] Figure 5C for Figure 5A Bottom perspective view of the deflection rod, showing the friction inducing washer.

[0039] Figure 6 for Figure 3 A side perspective view of the housing of the control handle, showing the spring screw and friction inducing washer.

[0040] Figure 7 is a side cross-sectional view of a spring screw engaged with a recess of a housing of a control handle according to an embodiment.

[0041] Fig. 8A is a top perspective view of a housing of a control handle according to an alternative embodiment.

[0042] Figure 8B is a bottom perspective view of a deflection rod according to an alternative embodiment.

[0043] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0044] Reference Figure 1 and Figure 2 In some embodiments, the deflectable catheter 10 includes an elongated deflectable shaft 12 , a distal actuator 14 (eg, a “pull cable” mapping assembly having electrodes), and a control handle 16 proximal to the shaft 12 for controlling deflection of the shaft 12 .

[0045] As is known in the art, the shaft 12 comprises a multi-lumen tube configured with at least two lumens, generally diametrically opposed to one another, through each of which extend respective pull wires actuated by the mechanism of the control handle, including the deflection rod 22. Such a shaft and control handle mechanism are described in U.S. Pat. No. 9,682,214, entitled "Control Handle With Rotational Cam Mechanism For Contraction / Deflection of Medical Device," the entire contents of which are incorporated herein by reference.

[0046] The control handle 16 includes a housing 18, which may be formed by a first portion or upper portion 18A and a second portion or lower portion 18B, which together enclose an interior space within the control handle. The control handle 16 defines a central longitudinal axis 20 that bisects the control handle into generally symmetrical elongated halves, namely, a left half 20L and a right half 20R.

[0047] like Figure 3 As shown in FIG. 1 , the upper portion 18A of the housing has an area of ​​a generally flat outer surface 24 on which the deflection rod 22 is mounted for attachment to the control handle 16. In some embodiments, the outer surface 24 is located closer to the distal end 16D of the control handle than the proximal end 16P, for example, at two-thirds of the length of the control handle that is closer to the distal end 16D than the proximal end 16P. Because the deflection rod 22 is mounted on the outer surface 24, the location of the outer surface 24 reflects ergonomic considerations when constructing the control handle 16 as a device that is held and manipulated by the operator's hand.

[0048] In the illustrated embodiment, the outer surface 24 is defined by a circular area. An opening 27 is formed in the upper portion 18A within the area of ​​the outer surface 24, the opening 27 being centered relative to the outer surface 24 and configured to receive a bolt (not shown) that secures the deflection rod 22 to the control handle 16 while allowing the deflection rod 22 to rotate relative to the housing 18 about a rotation axis 26 defined by the opening 27. The rotation axis 26 is generally perpendicular to the longitudinal axis 20, and the deflection rod 22 can be rotated by the user about the rotation axis 26 in opposite directions (arrows 35), thereby causing the catheter shaft 12 to deflect in opposite directions to the right and left of the longitudinal axis 20, respectively (arrows 36). Figure 1 ). Again, U.S. Patent No. 9,682,214, incorporated herein by reference above, discloses a deflection mechanism within a control handle that acts on a pull wire in response to a user's manipulation of a deflection rod when bi-directionally deflecting a catheter shaft. Figure 4A As shown in , when the deflection rod 22 is in a neutral position defined by alignment with the longitudinal axis 20, the catheter shaft 12 is not deflected. Figure 4B As shown in FIG. 1 , when the deflection rod 22 has been rotated to the right, the catheter shaft 12 is deflected to the right of the longitudinal axis 20 at an angle β (see arrow R). Figure 4C As shown in FIG. 1 , when the deflection rod 22 has been rotated to the left, the catheter shaft 12 is deflected to the left of the longitudinal axis 20 at an angle α (see arrow L).

[0049] In some embodiments, the deflection rod 22 has a bisecting axis 34 that divides the rod into two symmetrical halves (e.g., a right half and a left half), such as Figure 5A and Figure 5B When the deflection rod 22 is in the neutral position, the bisecting axis 34 is aligned with the longitudinal axis 20 of the control handle (see Figure 2 ). The deflection rod 22 has two arms 28A, 28B located on opposite sides of an axis 34, with one arm located on a respective side of the control handle 16. Positioned on the distal outer surface of the deflection rod 22 on the axis 34 is a visual marker 30 centered between the arms 28A, 28B. When the deflection rod 22 is in the neutral position, the visual marker 30 is aligned with the longitudinal axis 20 of the control handle 16 (see FIG. Figure 4A ), and when the deflection rod has been rotated, the visual marker 30 points to either side of the neutral position (see Figure 4B and Figure 4C The deflection lever 22 is configured to at least encourage an operator to hold the control handle 16 in their hand with their thumb and index finger placed on the distal surface of the respective arm 28A, 28B, wherein the deflection lever 22 can be rotated in opposite directions about the rotation axis 26 by movement of the operator's thumb and / or index finger.

[0050] refer to Figure 5B , Figure 5C and Figure 6 , a threaded boss 32 is formed in the underside of the deflection rod 22. The boss 32 defines a through hole extending from the underside to the outer surface 27 of the deflection rod 22 and defines an axis 25 parallel to the rotation axis 26 of the deflection rod 22 and thus perpendicular to the outer surface 27 of the deflection rod 22. The spring screw 40 ( Figure 6 ) and ball bearing 42( Figure 5C ) is inserted into the boss 21, and the ball bearing 42 is located between the spring screw 40 and the outer surface 24 of the control handle housing 18A below the deflection rod 22. Under the condition of being biased in the direction of the outer surface 24 by the resilient spring force of the spring screw 40, the ball bearing 42 maintains contact with the outer surface 24 in all rotational positions of the deflection rod 22 about the axis 26. Figure 7 As shown in , in some embodiments, a spring screw 40 has a head 37, an end 38 opposite the head, and a threaded outer portion 41 defining an inner core 43 along its length, the inner core 43 containing an elastic force member 45, such as a spring coil or a compressible fluid, which acts on a ball bearing 42 at the end 38 of the spring screw 40. The threaded outer portion 41 enables the spring screw 40 to be fixed in the boss 32, wherein its position (or depth) in the boss can be adjusted by turning the spring screw 40 at the head 37 by a tool such as a screwdriver. When the spring screw 40 is adjustably fixed in the boss, the ball bearing 42 under the elastic force of the force member 45 in the core 43 can move longitudinally along the axis 25 and has a "spring" effect relative to the threaded outer portion 41.

[0051] like Figure 3 As shown in FIG. 1 , the outer surface 24 of the control handle housing 18A is advantageously configured with a groove 44 that is aligned with the central longitudinal axis 34 ( Figure 2 ) and is also aligned with the longitudinal axis 34 of the deflection rod 22 when the deflection rod 22 is in the neutral position. Specifically, when the deflection rod 22 is in the neutral position, the spring screw 40 and the ball bearing 42 are vertically aligned with the groove 44, so that the ball bearing 42 enters the groove 44 under the elastic force of the spring screw 40. The size and shape of the groove 44 are set to receive the ball bearing 42, and also allow the ball bearing 42 to leave the groove when the operator rotates the deflection rod 22 about the axis 26 away from the neutral position (when deflecting the catheter shaft). Between the ball bearing 42 moving into and out of the groove 44 in response to the rotation of the deflection rod 22, when the ball bearing 42 is resting in the groove 44 with the deflection rod 22 in the neutral position, the ball bearing 42 presents an outer / protruding position relative to the threaded outer portion 41 ( Figure 7 ), and when the ball bearing 42 rests against the outer surface 24 when the deflection rod 22 is in the rotated position, the ball bearing 42 assumes an inner / retracted position relative to the threaded outer portion 41.

[0052] Advantageously, movement of the ball bearing 42 relative to the surrounding flat outer surface 24 into and out of the groove 44 provides a tactile indication to the thumb and index finger of the operator when the deflection rod 22 is in a neutral position or out of a neutral position and, correspondingly, when the catheter shaft 12 is in a deflection or out of a deflection. In some embodiments, the tactile indication or "feel" presented to the operator may include, for example, a "click" or other slightly detectable change in the ease or resistance of rotation of the deflection rod 22 as the ball bearing 42 slides into and out of the groove 44. It should be understood that the resilient force member 45, the ball bearing 42, and / or the groove 44 may be configured to increase or decrease the tactile indication, for example, such that the operator is required to apply a threshold amount of force with his thumb and index finger to rotate the deflection rod 22 in order to move the ball bearing 42 into engagement and / or out of engagement with the groove 44. In some embodiments, the friction inducing washer 60 is positioned between the deflection rod 22 and the outer surface 24 (see Figure 5C and Figure 6 ), so that the deflection rod 22 can better maintain its rotational position regardless of where the operator may set it without causing the catheter shaft 12 to lose its deflection and straighten.

[0053] In an alternative embodiment, if Fig. 8A and Figure 8B As shown in FIG, the underside of the deflection rod 22 is formed with a tab 70 that abuts against a textured surface, such as a plurality of protrusions or fins 72 formed on the outer surface 24 on the opposite side of the axis 20, thereby leaving a smooth gap 74 in the immediate vicinity of the longitudinal axis 20. Thus, the tab 70 contacts the ridge 72 only when the deflection rod 22 is rotated away from the neutral position on either side of the central longitudinal axis 20. The engagement between the tab 70 and the ridge can provide both a tactile and an audible indication of the rotation and / or rotational position of the deflection rod 22.

[0054] In some embodiments, the deflection rod 22 provides a tactile indicator of the deflection direction, such as Figure 5A and Figure 5B . On the outer surface of each arm 28A, 28B that contacts the operator's thumb and index finger, respectively, the outer surface of one arm is advantageously tactilely different from the other arm. In the illustrated embodiment, the outer surface of arm 28A is smooth, while the outer surface of arm 28B is formed with ridges 48. For a right-handed user, their right palm is placed over the deflection rod 22 of the catheter with a larger deflection on one side (e.g., left angle α=180 degrees) ( Figure 4C ) and has a smaller deflection on the other side (e.g., angle β = 90 degrees) ( Figure 4B), the thumb rests on the ridge 48 of arm 28B and the index finger rests on the smooth surface of arm 28A. With arm 28B on the larger deflection side (e.g., angle α=180 degrees), the ridge 48 tactilely informs the operator that his thumb controls the larger deflection side of the catheter and his index finger controls the smaller deflection side of the catheter (e.g., angle β=90). It should be understood that no matter how the operator grasps the control handle 16 or manipulates the deflection rod 22, whether the operator is right-handed or left-handed, or whether the operator uses the control handle right-side up (where the deflection rod 22 is visible) or upside down (where the deflection rod 22 is not visible), the tactile indicator (e.g., ridge 48) tactilely distinguishes one arm from the other.

[0055] The control handle housing 16 and the deflection rod 22 can be manufactured by injection molding. It should be understood that the boss 32 can be configured at any location in the underside 31 of the deflection rod where the boss does not interfere with the deflection rod or other components of the control handle. In the illustrated embodiment, the boss 32 is configured to align with the visual marker 30 and is located on the longitudinal bisecting axis 34 so that the deflection rod remains symmetrical about the axis 34 for simplifying the injection molding process by which the deflection rod can be manufactured.

[0056] The foregoing description has been presented with reference to the presently preferred embodiments of the invention. Those skilled in the art to which the invention pertains will appreciate that changes and modifications may be made to the structures described without intentionally departing from the principles, spirit and scope of the invention. Any feature or structure disclosed in one embodiment may be incorporated as needed or appropriate to replace or supplement other features of any other embodiment. As will be appreciated by those of ordinary skill in the art, the drawings are not necessarily drawn to scale. Therefore, the above-described specific embodiments should not be interpreted as being suitable only for the precise structures described and illustrated in the drawings, but rather should be interpreted as being consistent with and supporting the following claims, which have a full and fair scope of the invention.

Claims

1. A catheter, comprising: a control handle including an outer surface having a groove; a deflection rod mounted on the control handle over the recess, the deflection rod being configured to rotate relative to the control handle; Ball bearings; a spring screw configured to move the ball bearing into and out of engagement with the groove as the deflection rod rotates; as well as A shaft is located distal to the control handle, the shaft being responsive to the deflection rod for bi-directional deflection.

2. The catheter according to claim 1, wherein The ball bearing is located between the spring screw and the outer surface, and the spring screw is configured to urge the ball bearing toward the outer surface.

3. The catheter according to claim 1, wherein: The control handle defines a longitudinal axis, and the deflection rod is configured to rotate about an axis perpendicular to the longitudinal axis.

4. The catheter according to claim 1, wherein The deflection lever is configured with a boss through which the spring screw extends.

5. The catheter according to claim 1, wherein The deflection rod has a first arm with a tactilely smooth surface and a second arm with a tactilely ridged surface.

6. The catheter according to claim 1, wherein When the ball bearing is engaged with the groove, the deflection rod is in a neutral position.

7. The catheter according to claim 1, wherein: When the ball bearing is not engaged with the groove, the deflection lever is in a rotated position.

8. The catheter according to claim 5, wherein: When the deflection lever is in a neutral position, the shaft is not deflected.

9. The catheter according to claim 6, wherein: When the deflection lever is in a rotated position, the shaft deflects.

10. A catheter, comprising: a control handle defining a longitudinal bisecting axis and including an outer surface having a groove aligned with the longitudinal bisecting axis; a deflection rod mounted on the control handle, the deflection rod being configured for bidirectional rotation relative to the longitudinal bisector axis about a rotation axis perpendicular to the longitudinal bisector axis, the groove defining a neutral position of the bidirectional rotation of the deflection rod; a spring screw secured to the rod, the spring screw including a ball bearing configured to move into and out of the recess as the deflection rod rotates; as well as A shaft is located distal to the control handle, the shaft being responsive to the deflection rod for bi-directional deflection.

11. The catheter according to claim 10, wherein The bidirectional deflection of the shaft includes a larger deflection in one direction and a smaller deflection in the opposite direction.

12. The catheter according to claim 11, wherein The larger deflection is about 180 degrees, and the smaller direction is about 90 degrees.

13. The catheter according to claim 10, wherein: The deflection rod has one arm on one side of the longitudinal bisector axis and another arm on an opposite side of the longitudinal bisector axis.

14. The catheter according to claim 10, wherein: The deflection rod includes one arm having a tactilely uneven surface and another arm having a tactilely smooth surface.

15. The catheter according to claim 10, wherein The deflection rod includes a boss through which the spring screw extends.

16. The catheter of claim 10, wherein: The boss is parallel to the rotation axis.

17. The apparatus according to claim 10, wherein: The boss is perpendicular to the longitudinal bisector axis.

18. The catheter of claim 17, wherein: The boss is aligned with the bisecting axis of the deflection rod.

19. The catheter of claim 18, wherein: When the deflection lever is in the neutral position, the bisecting axis of the deflection lever is aligned with the longitudinal bisecting axis of the control handle.

20. The catheter of claim 10, further comprising a friction inducing washer between the deflection rod and the outer surface.

21. The catheter of Claim 10, further comprising a visual indicator on the deflection rod aligned with the spring screw.

22. A catheter, comprising: axis; a control handle having a housing configured with a recess; as well as A deflection rod is mounted on the housing over the groove and is configured to deflect the shaft as the deflection rod rotates, the deflection rod including a ball bearing and a spring screw, the spring screw being configured to mobilize the ball bearing into resilient contact with the groove when the deflection rod is rotated into a neutral position, such that the resilient contact provides a tactile indication of shaft deflection detected by the deflection rod.

23. The catheter of claim 22, wherein: When the deflection lever is rotated away from the neutral position, the ball bearing has a resilient contact with the housing.

24. The catheter of claim 22, wherein: The groove is aligned with a longitudinal axis of the control handle.

25. The catheter of claim 22, wherein: The deflection rod includes a boss through which the spring screw extends.

26. The catheter of claim 24, wherein: The spring screw includes a head and an end, the head and the end together defining an axis generally perpendicular to the longitudinal axis, and the ball bearing is located between the end and the groove.

Images