This invention relates, generally, to catheter control and more particularly, to a catheter control assembly. Preferably, but not essentially, the catheter control assembly is remotely controlled.
Generally, in the manipulation of catheters in cardiovascular procedures, the catheter sheath is inserted, by an introducer, through the vasculature of a patient until the distal end of the catheter is at the desired location in the patient's heart. It will be appreciated that to manipulate the catheter through the patient's vasculature requires great dexterity and steadiness on the part of the clinician. The more stable the catheter, the smaller the incision for minimally invasive surgery can be with the resultant improved convalescence time and costs associated with such convalescence.
In addition, use is generally made of radio opaque markers on the catheters for determining the location of the catheter within the patient's vasculature. These radio opaque markers are detected by X-ray fluoroscopy which means that, when the clinician is conducting a procedure in proximity to the patient, the clinician is exposed to radiation arising due to the X-ray fluoroscopy. It would be beneficial to be able to remove the clinician from exposure to this radiation. Thus, to be able to control manipulation of the catheter remotely would be advantageous.
According to a first aspect of the invention, there is provided a catheter control assembly which includes
a support structure;
a drive arrangement supported by the support structure;
an elongate displacement mechanism associated with the drive arrangement to be displaced at least axially under the action of the drive arrangement; and
a carrier, for mounting at least a part of a catheter handle, mounted on the displacement mechanism, the carrier comprising a plurality of independently displaceable receiving formations, each receiving formation, in use, receiving a part of the catheter handle and at least two of the receiving formations being axially displaceable relative to each other.
The displacement mechanism may include a telescopic arm assembly extending from the support structure and on which the carrier is mounted, the telescopic arm assembly comprising a plurality of telescopically arranged arms and each arm mounting a receiving formation of the carrier.
The telescopic arm assembly may be at least axially and rotatably arranged relative to the support structure for effecting axial and rotational displacement of the carrier relative to the support structure. The telescopic arm assembly may include at least a first arm and a second arm, the second arm of the telescopic arm assembly displacing one receiving formation of the carrier relative to at least one other receiving formation of the carrier. The telescopic arm assembly may include at least one further arm for displacing another receiving formation of the carrier relative to at least one other receiving formation of the carrier.
Preferably, the carrier is removably attached to the telescopic arm assembly.
The assembly may include a controller for controlling operation of the drive arrangement to effect displacement of the displacement mechanism. Preferably, the controller is arranged remotely of the support structure. In an embodiment, the controller may be shaped to mimic the appearance and feel of the catheter handle.
The drive arrangement may comprise a plurality of drive motors, each drive motor driving a part of the displacement mechanism. Each drive motor may be a stepper motor. It will be appreciated that each arm of the telescopic arm assembly of the displacement mechanism may have a drive motor associated with it, rotary motion of the drive motor being translated into linear motion of the relevant telescopic arm assembly. The drive arrangement may further include a rotation control motor for effecting rotary control of the displacement mechanism. The rotation control motor may also be a stepper motor.
The support structure may include a housing in which the drive arrangement is received with the displacement mechanism extending from the housing.
In an embodiment, the carrier may be in the form of a cradle in which at least a part of the catheter handle is receivable. The cradle may include an elongate body member containing the receiving formations and a mounting arrangement arranged at an opposed end of the body member for mounting the body member to a displacement mechanism of a catheter control assembly.
The mounting arrangement may comprise a plurality of independently displaceable mounting members and each receiving formation may be connected to an associated mounting member via a pair of transversely spaced limbs. The limbs on each side of the body member may be shaped to nest within each other.
In another embodiment, the carrier may comprise a plurality of discrete components mounted on one of the arms of the telescopic arm assembly, each component defining a mounting formation for receiving a part of the catheter handle. In this embodiment, each arm may comprise a pair of transversely spaced members.
According to a second aspect of the invention, there is provided a catheter control assembly which includes
a carrier for mounting a catheter handle, the carrier comprising a plurality of independently displaceable receiving formations, each receiving formation, in use, receiving a part of the catheter handle;
a telescopic arm assembly on which the carrier is mounted, the telescopic arm assembly comprising a plurality of telescopically arranged arms and each arm mounting a receiving formation; and
a drive arrangement which acts on the arms of the telescopic arm assembly for effecting displacement of the telescopic arm assembly and the carrier and at least certain arms of the telescopic arm assembly and the receiving formations of the carrier.
The assembly may include a controller arranged remotely of the carrier for controlling operation of the drive arrangement.
According to a third aspect of the invention, there is provided a remote control unit for remotely controlling a catheter, the remote control unit including
a drive arrangement which acts on the carrier for effecting displacement of the carrier and the receiving formations of the carrier;
an elongate displacement mechanism associated with the drive arrangement to be displaced at least axially under the action of the drive arrangement;
a carrier for mounting at least a part of a catheter handle mounted on the displacement mechanism, the carrier comprising a plurality of independently displaceable receiving formations, each receiving formation, in use, receiving a part of the catheter handle and at least two of the receiving formations being axially displaceable relative to each other; and
a controller arranged remotely of the drive arrangement for controlling operation of the drive arrangement.
The displacement mechanism may include a telescopic arm assembly extending from the support structure and on which the carrier is mounted, the telescopic arm assembly comprising a plurality of telescopically arranged arms and each arm mounting a receiving formation of the carrier.
According to a fourth aspect of the invention, there is provided a cradle for a catheter control assembly, the cradle including
an elongate body member;
a plurality of relatively displaceable receiving formations arranged proximate a first end of the body member, each receiving formation being configured to receive a part of a catheter handle, the parts of the catheter handle being displaceable relative to one another; and
a mounting arrangement arranged at an opposed end of the body member for mounting the body member to a displacement mechanism of a catheter control assembly.
The cradle may be disposable and the mounting arrangement may be configured to mount the body member releasably on the displacement mechanism of the catheter control assembly.
The mounting arrangement may comprise a plurality of independently displaceable mounting members and each receiving formation may be connected to an associated mounting member via a pair of transversely spaced limbs. The limbs on each side of the body member may be shaped to nest within each other.
a shows a three dimensional front view of a carrier of the assembly;
b shows a three dimensional rear view of the carrier of the assembly;
In the drawings, reference numeral 10 generally designates an embodiment of a catheter control assembly. The assembly 10 includes a support structure in the form of a housing 12. The housing 12 houses a driver arrangement 14 (
The housing 12 has a base 24 and a lid portion 26 removably mounted on the base 24. The lid portion 26 is removable to enable access to be gained to those parts of the displacement mechanism 16 and the drive arrangement 14 arranged within the housing 12 as shown in greater detail in
The housing 12 further includes a rear cover 28 (
The displacement mechanism 16 comprises a telescopic arm assembly 17 having a first, outer arm 32 carrying a mounting formation (not shown in this embodiment) at its free end on which a mounting member 34 of the cradle 21 is receivable. A second arm (also not shown in this embodiment) is nested within the arm 32 and mounts a second mounting member 36 of the cradle 21. A third arm (also not shown) of the telescopic arm assembly 17 is telescopically received within the second arm and carries a mounting formation for mounting a third mounting member 38 of the cradle 21. Thus, it will be appreciated that the arms are nested within each other and are telescopically arranged with respect to each other.
The internal assembly 27 includes a slide 40. A mounting plate 42 is fixedly mounted to the slide 40.
An electrode sheath of a catheter manufactured in accordance with the applicant's International Patent Application No. PCT/AU01/01339 dated 19 Oct. 2001 and entitled “An electrical lead” has a lumen. The electrode sheath has an inner tubular member. Electrical conductors for electrodes at a distal end of the catheter are wound about the inner tubular member and the conductors are encased in a jacket. With this arrangement, the lumen is unimpeded and facilitates insertion of a steering shaft into the lumen for controlling steering and/or deflection of a distal end of the catheter. The steering shaft is made in accordance with the teachings of the applicant's International Patent Application No. PCT/AU2005/000216 dated 18 Feb. 2005 and entitled “A steerable catheter”. As described in that patent specification, the steering shaft has an outer, tubular member with a bend-enhancing region formed proximate a distal end of the tubular member. An inner actuator is received within the tubular member. Relative displacement between the actuator and the tubular member causes bending or deflection of the distal part of the steering shaft at the bend-enhancing region. As described in International Patent Application No. PCT/AU2005/000216, relative movement is achieved by attaching the tubular member of the steering shaft to a handle body of the catheter handle 22 with the actuator being attached to a mounting member 24 of the handle via a slide (not shown) within the handle 22. Relative movement between the slide and the handle body causes deflection at the distal end of the steering shaft.
Thus, the internal assembly 27 further includes a second mounting plate 44 displaceably arranged relative to the mounting plate 42 in the direction of arrows 46 (
It will be noted that the mounting plate 44 is displaceable relative to the mounting plate and the slide 40. The slide 40 supports limit switches 52 which limit the displacement of the mounting plate 44 relative to the mounting plate 42. A linear transversely arranged linear sensor 94 carried on the slide 40, the linear sensor 94 defining a slot 96 through which the pin 92 extends. The linear sensor 94 provides a displacement measurement of the movement of the telescopic arm assembly 17 relative to the housing 12. The angled arrangement of the guide beam 88 means that approximately 20 mm of movement of the pin 92 in the slot 96 of the linear sensor 94 translates into approximately 200 mm of motion in the direction of arrows 76. The limits of axial movement in the direction of arrows 76 is controlled by limit switches 98 mounted at opposed ends of the slide 40.
The discs 82 are rotatably supported in the housing 12. The drive arrangement 14 includes a drive motor 100 mounted on an inner surface of the end wall 84. The drive motor 100 rotatably drives the discs 82 via pulleys 101 and a drive belt 103.
Each of the drive motors 48, 66, 78 and 100 is a stepper motor for enabling incremental, discrete steps to be controlled by the controller 50 depending on the required movement.
Referring now to
The receiving formation 102 is connected to the mounting member 34 by a pair of transversely spaced limbs 112. The receiving formation 104 is connected to the mounting member 36 by a pair of transversely spaced limbs 114 and, similarly, the receiving formation 106 is connected to the mounting member 38 by a pair of transversely spaced limbs 116. As shown more clearly in
This nested arrangement of the limbs 112, 114 and 116 improves the stability of the cradle 21 and, more particularly, displacement of the receiving formations 102, 104 and 106 relative to one another. The nested arrangement of the limbs 112, 114 and 116 also serves to constrain the arms of telescopic arm assembly 17 against rotation relative to one another. It also creates a more compact cradle 21.
Referring to
In either case, the joysticks 124, 126 and 128 are used for controlling manipulation of the catheter handle 22. More particularly, the joystick 124 performs two functions. The joystick 124 acts on the motor 100 so that moving the joystick 124 left and right rotates the internal assembly 27 counter-clockwise and clockwise, respectively. Moving the joystick 124 forward and backward acts on the motor 78 to cause forward and backward axial displacement of the internal assembly 27 in the direction of arrows 76, respectively.
The joystick 126 controls steering and/or deflection of the catheter. Thus, moving the joystick 126 forward and backwards control the motor 48 and effects axial displacement of the plate 44 with respect to the plate 42 in the direction of arrows 46. Thus, moving the joystick 126 forwards effects deflection of the catheter tip and moving the joystick 126 backwards cancels out the deflection.
The joystick 128 also performs a single function. The joystick 128 acts on the motor 66 and effects projection of the electrode sheath of the catheter relative to the steering shaft of the catheter. Thus, moving the joystick 128 forwards causes the catheter sheath to be projected from the steering shaft of the catheter and moving the joystick 128 backwards retracts the catheter sheath back on to the steering shaft.
In
With this arrangement, the clinician uses the handle controller 50 as though using the catheter handle 22 itself. Thus, to effect displacement of the entire catheter along the longitudinal axis of the catheter, the clinician 50 moves the handle controller 50 in the direction of arrows 135 on the guide rod 132. To effect steering or deflection of the catheter tip, the clinician uses the steering control knob 108 and moves it in the direction of arrows 136. To effect projection of the electrode sheath relative to the steering shaft, the clinician moves the projection control knob 60 in the direction of arrows 138 to act on the motor 66 to cause extension of the electrode sheath relative to the steering shaft or to retract the electrode sheath on to the steering shaft, as the case maybe.
Similarly, to effect rotation of the entire catheter handle 22, the clinician rotates the controller 50 and the guide rod 132 relative to the fixed support member 134. The controller 50 is able to be rotated relative to the fixed support member 134 to improve wrist comfort for the clinician. Preferably, it is necessary to raise the controller 50 from its rest position (not shown) to its illustrated, operative position, by pivoting the rod 132 about a pivot point (not shown) before the actuation of any of the drive motors is enabled so that the assembly 10 cannot be inadvertently actuated.
With reference to
In this embodiment of the invention, rather than a dedicated cradle, the carrier 20 comprises three discrete components, each defining a receiving formation 140, 142 and 144. The projection control knob 60 is received in the receiving formation 140, the steering control knob 108 is received in the receiving formation 142 and the raised abutment 110 (not visible in
Also, instead of the displacement mechanism 16 comprising a telescopic arm assembly 17 where there are single nested arms, an arm comprising a pair of transversely spaced arm members 146, 148 and 150, is associated with each receiving formation 140, 142 and 144, respectively. Each arm member 146 is telescopically received in its associated arm member 148 which, in turn, is telescopically received in its associated arm member 150. The operation of this embodiment is similar to that described above with reference to
Referring now to
In this embodiment, the support structure includes a chassis 152 received in the housing 18. The housing 18 is omitted from
The internal assembly 27 includes a pair of spaced, parallel guide rails 164 extending between the plates 156 and 158 of the chassis 152. A drive block assembly 166 is slidably supported on the guide rails 164 to be displaceable in the direction of arrows 76 to effect axial displacement of the cradle 21 (not shown in this embodiment) mounted on the end of the telescopic arm assembly 17 to effect axial displacement of the entire catheter, as described above with reference to
A second drive block assembly 168 is displaceably arranged relative to the drive block assembly 166. The drive block assembly 168 is also mounted on the rails 164 and carries the drive motor 48. The drive motor 48 is mounted on a lead screw 167 which is fast with a bracket 169 suspended from the drive block assembly 166. Thus, rotational motion of the drive motor 48 translates into linear motion relative to the lead screw 167.
A third drive block assembly 170 is mounted on the guide rails 164 and supports the drive motor 66. The drive block assembly 168 is mounted on one side of the drive block assembly 166 with the drive block assembly 170 being mounted on an opposed side of the drive block assembly 166. The drive motor 66 is mounted on a lead screw 171 which is fast with the bracket 169 suspended from the drive block assembly 166 so that rotational motion of the drive motor 66 translates into linear motion relative to the lead screw 171.
Each of the drive block assemblies 166, 168 and 170 is mounted on the guide rails 164 via bearings 172 to facilitate displacement of the drive block assemblies 166, 168 and 172 on the guide rails 164.
In this embodiment, the telescopic arm assembly 17 is shown more clearly, particularly in
The outer arm 32 of the telescopic arm assembly 17 is mounted to the drive block assembly 170, the arm 174 is mounted to the drive block assembly 166 and the arm 176 is mounted to the drive block assembly 168.
The outer arm 32 of the telescopic arm assembly 17 is connected to the mounting member 34 (
The central arm 174 supports a mounting formation 184 at its distal end. Once again, the mounting formation 184 has a pair of opposed radially outwardly extending pins 186. The pins 186 engage a pair of opposed L-shaped slots 188 (
Finally, the inner arm 176 supports a mounting formation 190 at its distal end. The mounting formation 190 has a pair of opposed, radially outwardly extending pins 192. These pins 192 engage a pair of opposed L-shaped slots (not visible in the drawings) of the mounting member 38 of the cradle 21 bayonet fashion.
In this embodiment, axial displacement of the drive block assembly 166 is controlled by the stepper motor 78. The stepper motor 78 drives a drive pulley 194 (
To effect rotation of the entire displacement mechanism 16, the stepper motor 100 is mounted on the drive block assembly 168 and rotates the inner arm 176 and, in so doing, the entire telescopic arm assembly 17 by means of the pulleys 101 and the drive belt 103. As described above, the nested limb arrangement of the cradle 21 constrains the arms 32, 174 and 176 of the telescopic arm assembly 17 against rotation relative to one another. Also, the arms can rotate relative to the drive block assemblies 166, 168 and 170 by means of bearings arranged in the drive block assemblies 166, 168 and 170.
To effect projection of a catheter sheath of the catheter relative to a steering shaft of the catheter sheath, the stepper motor 66 is operated by the clinician using the relevant controller 50. This displaces the drive block assembly 170 relative to the drive block assembly 166 in the direction of arrows 64 and, in turn, displaces the mounting member 34 of the cradle 21 relative to the other mounting members 36 and 38. As described above, the projection control knob 60 is received in the receiving formation 102 and displacement of the mounting member 34 relative to the other mounting members 36 and 38 displaces the receiving formation 102 relative to the other receiving formations 104 and 106 in an axial direction. This effects projection and retraction of the catheter sheath relative to the steering shaft of the catheter.
To effect steering and/or deflection of a distal end of the catheter, the stepper motor 48 is operated by the clinician using the controller 50. This effects displacement of the drive block assembly 168 in the direction of arrows 46 and, in turn, displacement of the mounting formation 190 of the displacement mechanism 16 relative to the other mounting formations 178 and 184. Likewise, because the mounting member 38 of the cradle 21 is mounted on the mounting formation 190, displacement of the drive block assembly 168 similarly effects displacement of the mounting member 38 of the cradle 21 relative to the other mounting members 34 and 36.
When the stepper motor 48 is operated to effect steering and/or deflection, the mounting member 38 is displaced axially relative to the other mounting members 34 and 36. This causes the receiving formation 106, containing the raised, ridged abutment 110 of the catheter handle 22 to be displaced relative to the steering control knob 108 received in the receiving formation 104. This effects steering and/or deflection of the distal end of the catheter.
It is to be noted that, in this embodiment, linear potentiometers and limit switches can also be used to control and limit motion of the displacement mechanism 16. Instead, as illustrated in
It is an advantage of the invention that a catheter control assembly 10 is provided which facilitates stable control of a catheter and obviates problems arising from vibrations, etc. In addition, the catheter control assembly 10 is able to be operated remotely by a clinician thereby taking the clinician out of a field of radiation in which the clinician may otherwise need to operate. Greater stability of the catheter using the control assembly 10 also improves accuracy of procedures carried out by the clinician. This stability is enhanced by the use of the telescoped arms which, in addition, reduces the size and footprint of the assembly 10.
It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the invention as shown in the specific embodiments without departing from the scope of the invention as broadly described. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.
The present application claims priority from U.S. Provisional Patent Application No. 60/925,992, filed Apr. 23, 2007, which is hereby incorporated by reference in its entirety.
Number | Date | Country | |
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60925992 | Apr 2007 | US |