Patent Application
20240108858
The present disclosure generally relates to the field of catheters (e.g., neuromodulation; denervation) and, more particularly, to straightening a catheter shaft.
At least some catheters have a catheter shaft that incorporates a non-linear catheter shaft section at an appropriate location along the length of the catheter shaft. For instance, some diagnostic catheters have a pigtail curve along a portion of the catheter shaft. Certain neuromodulation and/or renal denervation catheters utilize a catheter shaft with a distal end section having a helical or spiral configuration. One or more electrodes may be spaced along such a distal end section. A guide wire may be directed through a lumen of at least the distal end section of the catheter shaft. Such a guide wire retains the distal end section in a delivery configuration where the catheter shaft may be directed into/through the vasculature of a patient. Once the distal end section of the catheter shaft is in the desired location within the vasculature, the guide wire may be withdrawn from the distal end section of the catheter shaft such that it expands within the vasculature, typically into contact with an inner wall of the vasculature. Standalone catheter shaft straighteners exist to facilitate insertion of the guide wire into/through the distal end section of the catheter shaft, and are generally in the form of a tube.
A handle of a neuromodulation catheter is typically used to torque the catheter shaft and to advance the catheter shaft within the patient's vasculature. Torqueing and/or advancement of the catheter shaft may be undertaken during repositioning, within the vasculature, of a deployed distal end section of a catheter shaft of the above-noted type.
Options for introducing a catheter into the patient's vasculature include using a femoral access, a radial access, a brachial access, and the like. The distance between a typical femoral access and the renal artery is typically significantly less than the distance between a typical radial access and the same renal artery. As such, the same renal neuromodulation/denervation catheter is typically sold in two different configurations for these different vasculature accesses. The catheter shaft of a renal neuromodulation/denervation catheter for a radial access is typically longer than the catheter shaft of a renal neuromodulation/denervation catheter for a femoral access.
The present invention is directed to a multi-function catheter shaft tool. Both the configuration of such a multi-function catheter shaft tool and operational characteristics, operation, assembly, and manufacture of such a multi-function catheter shaft tool are within the scope of this Summary. The multi-function catheter shaft tool may be used in conjunction with a catheter of any appropriate type and that provides any appropriate function or combination of functions when disposed in a patient's vasculature (e.g., diagnostic, therapeutic, neuromodulation, denervation).
A multi-function catheter shaft tool in accordance with the present invention includes a tool distal end and a tool proximal end. The spacing between the tool distal end and the tool proximal end may define/correspond with a length dimension of the tool. In any case, a lumen extends through an entire length of the multi-function catheter shaft tool and is sized to accommodate a catheter shaft. As such, a catheter shaft can extend completely through the multi-function catheter shaft tool (e.g., the multi-function catheter shaft tool may be mounted on a catheter shaft).
The multi-function catheter shaft tool further includes both a catheter shaft straightener and a catheter shaft actuator (e.g., for actuating or moving the catheter shaft relative to the patient's vasculature in some fashion) that are collectively rotatable (e.g., about the length dimension of the tool). The catheter shaft straightener extends distally of the catheter shaft actuator (e.g., a proximal end portion of the catheter shaft straightener may extend at least into a distal end of the catheter shaft actuator), and may include the noted tool distal end. The multi-function catheter shaft tool also includes a catheter shaft clamp that is disposable in each of a clamping configuration and a released configuration.
A number of feature refinements and additional features are applicable to the present invention. These feature refinements and additional features may be used individually or in any combination. Disposing the catheter shaft clamp in the released configuration allows the multi-function catheter shaft tool to be moved along and relative to the length of the catheter shaft to a desired position, and the catheter shaft clamp may then be disposed in its clamping configuration. For instance, the multi-function catheter shaft tool may be moved in a distal direction when mounted on a catheter shaft (e.g., away from a catheter handle) such that a distal end section of the catheter shaft is directed into the catheter shaft straightener. Advancing the multi-function catheter shaft tool in a distal direction, relative to the catheter shaft, and with the distal end section of the catheter shaft being introduced into the catheter shaft straightener, may be used reduce the profile of the distal end section of the catheter shaft (e.g., to accommodate directing a guide wire into a lumen that extends from the distal end of the catheter shaft and in a proximal direction). However, the catheter shaft straightener may be used to move/force any length segment of a catheter shaft toward a “straighter” profile. For instance, a catheter shaft may include one or more curves along its length dimension, and the catheter shaft straightener may be used to reduce the curvature of one or more portions of the catheter shaft.
Disposing the catheter shaft clamp in its clamping configuration may be used for any appropriate purpose, including loading a catheter shaft onto a guide wire. A user may engage the catheter shaft actuator (or a grip or a gripping section for the multi-function catheter shaft tool), to torque the catheter shaft, to advance the catheter shaft within/along the vasculature of a patient (e.g., by pushing or pulling on the catheter shaft actuator), or both, all with the catheter shaft clamp being disposed in its clamping configuration. With the catheter shaft being in its released configuration, the multi-function catheter shaft tool may be advanced along and relative to the catheter shaft in the direction of a patient vasculature access to dispose the catheter shaft actuator in a desired spaced relation to this patient vasculature access, at which time the catheter shaft clamp may be disposed in the clamping configuration for use of the multi-function catheter shaft tool in accordance with the foregoing.
The lumen may be of any appropriate size and/or shape, and includes any passageway or “open space” that accommodates a catheter shaft extending completely through the multi-function catheter shaft tool, proceeding from the tool distal end to the tool proximal end. All or a portion of the lumen that extends along an entire length of the catheter shaft straightener may be defined by an annular inner wall. At least a portion of the catheter shaft straightener that interfaces with a catheter shaft, when the multi-function tool is mounted on the catheter shaft, may be formed from a material that is “softer” than portions of the multi-function tool that do not interface with the catheter shaft. For instance, interfacing portions of the catheter shaft straightener (that interface with the catheter shaft) may be formed from materials such as silicone or the like.
The catheter shaft actuator may be incorporated at any appropriate portion along the length of the multi-function catheter shaft tool, including at a proximal end of the tool. However, at least part of the catheter shaft straightener should extend distally of a distal end of the catheter shaft actuator. One embodiment has an effective outer diameter of the catheter shaft actuator being greater than an effective outer diameter of the catheter shaft straightener. The catheter shaft actuator may also be characterized as a grip or the like (e.g., to accommodate engagement by a user when actuating/moving the catheter shaft in accordance with the foregoing).
The multi-function catheter shaft tool may further include a clamping actuator that is operatively interconnected with the catheter shaft clamp. The clamping actuator may be of any appropriate configuration, but is movable between at least two different positions to accommodate changing the catheter shaft clamp between its clamping configuration and its released configuration. One embodiment has the catheter shaft actuator being in the form of a cap that is detachably engaged (e.g., via a threaded connection) with the catheter shaft straightener. Advancing the catheter shaft actuator, relative to the catheter shaft straightener and in the direction of the tool distal end, may be utilized to change the catheter shaft clamp from its released configuration to its clamping configuration. In this instance the catheter shaft actuator also functions as the clamping actuator. Advancing the catheter shaft actuator, relative to the catheter shaft straightener and away from the tool distal end, may be utilized to change the catheter shaft clamp from its clamping configuration to its released configuration. The clamping actuator could also be configured for movement relative to the catheter shaft actuator, and may be disposed at any appropriate location of the multi-function catheter shaft tool (e.g., disposed on an exterior of the catheter shaft actuator).
Further disclosed herein is a multi-function catheter shaft tool, wherein a catheter shaft straightener of the tool may be used to straighten a distal end section of a catheter shaft when directed within the catheter shaft straightener, wherein a catheter shaft actuator of the tool may be used to torque the catheter shaft, advance the catheter shaft relative to a patient's vasculature, or both, and wherein the catheter shaft straightener and the catheter shaft actuator are structurally connected (i.e., an integrated structure).
Various aspects of the present disclosure are also addressed by the following paragraphs and in the noted combinations:
The present disclosure is applicable to apparatuses and methods for achieving electrically and/or thermally-induced neuromodulation/denervation (e.g., rendering neural fibers that innervate the kidney inert, inactive or otherwise completely or partially reduced in function) by percutaneous transluminal intravascular access. Embodiments of the present technology relate to a treatment device (e.g., treatment catheter) having a therapeutic assembly (e.g., one or more energy elements) on a distal portion of the catheter shaft. After deployment in a target blood vessel of a human patient, the distal portion of the assembly is transformable between a delivery state having a low-profile that is configured to pass through the vasculature and a deployed state having a radially expanded shape (e.g., generally spiral/helical or coil) in which the distal portion is maintained in stable apposition with an inner wall of the target blood vessel (e.g., renal artery).
The system can also include an energy source or energy generator external to the patient in electrical communication with energy elements of the therapeutic assembly. In operation, the energy elements are advanced to a target blood vessel, such as the renal artery, along a percutaneous transluminal path (e.g., a femoral artery puncture, an iliac artery and the aorta, a radial artery, or another suitable intravascular path), and then energy is delivered to the wall of the target blood vessel via the energy elements. Suitable energy modalities include, for example, electrical energy, radio frequency (RF) energy, pulsed electrical energy, ultrasound, or thermal energy. The treatment device carrying the energy elements can be configured such that the energy elements are in constant apposition with the interior wall of the target blood vessel when in the deployed state (e.g., radially expanded to have a spiral/helical shape). The pre-formed spiral/helical shape of the deployed portion allows blood to flow through the assembly during therapy, which is expected to help cool the therapy assembly to prevent clot formation that may result in occlusion of the blood vessel during activation of the energy elements. The spiral/helical shape also enhances the apposition of the energy elements with the inner wall of target blood vessels and makes the therapeutic assembly adaptable to a range of vessel diameters. The largest diameter vessel in the range is at least slightly smaller than the free or un-constrained diameter of the pre-formed spiral/helical shape in order to provide and maintain adequate contact between the energy elements and the vessel wall.
Specific details of several embodiments are described herein. Although many of the embodiments are described with respect to devices, systems, and methods for intravascular renal neuromodulation, other applications and other embodiments in addition to those described herein are within the scope of the present technology. For example, at least some embodiments of the present technology may be useful for intraluminal neuromodulation, extravascular neuromodulation, non-renal neuromodulation, and/or use in therapies other than neuromodulation. It should be noted that other embodiments in addition to those disclosed herein are within the scope of the present technology. Further, embodiments of the present technology can have different configurations, components, and/or procedures than those shown or described herein. Moreover, a person of ordinary skill in the art will understand that embodiments of the present technology can have configurations, components, and/or procedures in addition to those shown or described herein and that these and other embodiments can be without several of the configurations, components, and/or procedures shown or described herein without deviating from the present technology.
As used herein, the terms “distal” and “proximal” define a position or direction with respect to a clinician or a clinician's control device (e.g., a handle of a neuromodulation catheter). The terms, “distal”, “distally”, or the like refer to a position distant from or in a direction away from a clinician or a clinician's control device along the length of device. The terms “proximal”, “proximally”, or the like refer to a position near or in a direction toward a clinician or a clinician's control device along the length of device.
The distal portion 108a of the shaft 108 is configured to be moved within a lumen of a human patient and locate the neuromodulation/denervation assembly 120 at a target site within or otherwise proximate to the lumen. For example, shaft 108 can be configured to position the neuromodulation/denervation assembly 120 within a blood vessel, a duct, an airway, or another naturally occurring lumen within the human body. In certain embodiments, intravascular delivery of the neuromodulation/denervation assembly 120 includes percutaneously inserting a guide wire 140 (
Once at the target site, the neuromodulation/denervation assembly 120 can be configured to apply stimuli, detect resultant hemodynamic responses, and provide or facilitate neuromodulation therapy at the target site (e.g., using the metallic elements 122 and/or other energy delivery elements). For example, the neuromodulation/denervation assembly 120 can detect vessel impedance via the metallic elements 122, detect blood flow via a flow sensing element (e.g., a Doppler velocity sensing element (not shown)), detect local blood pressure within the vessel via a pressure transducer or other pressure sensing element (not shown), and/or detect other hemodynamic parameters. The detected hemodynamic responses can be transmitted to the console 104 and/or another device external to the patient. The console 104 can be configured to receive and store the recorded hemodynamic responses for further use by a clinician or operator. For example, a clinician can use the hemodynamic responses received by the console 104 to determine whether an application of neuromodulation energy was effective in modulating nerves to a desired degree.
The console 104 can be configured to control, monitor, supply, and/or otherwise support operation of the neuromodulation/denervation catheter 102. The console 104 can further be configured to generate a selected form and/or magnitude of energy for delivery to tissue at the target site via the neuromodulation/denervation assembly 120, and therefore the console 104 may have different configurations depending on the treatment modality of the neuromodulation/denervation catheter 102. For example, when the neuromodulation/denervation catheter 102 is configured for electrode-based, heat-element-based, or transducer-based treatment, the console 104 can include an energy generator (not shown) configured to generate RF energy (e.g., monopolar and/or bipolar RF energy), pulsed electrical energy, microwave energy, optical energy, ultrasound energy (e.g., intravascularly delivered ultrasound, and/or HIFU), direct heat energy, radiation (e.g., infrared, visible, and/or gamma radiation), and/or another suitable type of energy. When the neuromodulation/denervation catheter 102 is configured for cryotherapeutic treatment, the console 104 can include a refrigerant reservoir (not shown), and can be configured to supply the neuromodulation/denervation catheter 102 with refrigerant. Similarly, when the neuromodulation/denervation catheter 102 is configured for chemical-based treatment (e.g., drug infusion), the console 104 can include a chemical reservoir (not shown) and can be configured to supply the neuromodulation/denervation catheter 102 with one or more chemicals. In some embodiments, the console 104 can include one or more fluid reservoirs (not shown) for coolant and/or irrigant (e.g., saline) to be delivered to the metallic elements 122 and/or the dielectric material 124.
In selected embodiments, the system 100 may be configured to deliver a monopolar electric field via one or more of the metallic elements 122. In such embodiments, a neutral or dispersive electrode 130 may be electrically connected to the console 104 and attached to the exterior of the patient. In embodiments including multiple metallic elements 122, the metallic elements 122 may deliver power independently (i.e., may be used in a monopolar fashion), either simultaneously, selectively, or sequentially, and/or may deliver power between any desired combination of the metallic elements 122 (i.e., may be used in a bipolar fashion). In addition, an operator optionally may be permitted to choose which metallic elements 122 are used for power delivery in order to form customized lesion(s) within the renal artery, as desired. One or more sensing elements (not shown), such as one or more temperature (e.g., thermocouple, thermistor, etc.), pressure, optical, flow, chemical, and/or other sensing elements, may be located proximate to, within, or integral with the metallic elements 122. The sensing element(s) and the metallic elements 122 can be connected to one or more supply wires (not shown) that transmit signals from the sensing element(s) and/or convey energy to the metallic elements 122.
In various embodiments, the system 100 can further include a controller 114 communicatively coupled to the neuromodulation/denervation catheter 102. The controller 114 can be configured to initiate, terminate, and/or adjust operation of one or more components (e.g., the metallic elements 122) of the neuromodulation/denervation catheter 102 directly and/or via the console 104. In other embodiments, the controller 114 can be omitted or have other suitable locations (e.g., within the handle 110, along the cable 106, etc.). The controller 114 can be configured to execute an automated control algorithm and/or to receive control instructions from an operator. Further, the console 104 can be configured to provide feedback to an operator before, during, and/or after a treatment procedure via an evaluation/feedback algorithm 116.
A schematic of a vasculature for a patient 150 is presented in
What may be referred to as a neuromodulation or denervation catheter assembly is illustrated in
The catheter 200 of
A proximal portion of the catheter shaft 218 is disposed within the catheter handle 210, with the catheter shaft 218 extending distally of the distal end 214 of the catheter handle 210. The catheter shaft 218 includes a distal end section 222 that is also shown in
A plurality of electrodes 224 are spaced along the length of the distal end section 222. Each electrode 224 may be in the form of an annular band. In any case and as shown in
A representative configuration of the catheter assembly 190 of
One embodiment of a multi-function catheter shaft tool is shown in
The multi-function catheter shaft tool 270 includes a distal end 272 and a proximal end 274 that are spaced from one another along a length dimension of the tool 270. The tool 270 may be of any appropriate length. A lumen 276 extends through an entirety of the length of the tool 270 (e.g., from its distal end 272 to its proximal end 274). This allows the tool 270 to be disposed anywhere along the length dimension of the catheter shaft 218, including where the catheter shaft 218 extends proximally of the tool 270. The cross-sectional shape of the lumen 276 may be constant throughout the length of the tool 270 although such is not required. The lumen 276 merely needs to accommodate passage of the catheter shaft 218 therethrough, and as such at least a portion of the lumen 276 need not necessarily be defined by an annular inner wall along the entirety of its length.
The multi-function catheter shaft tool 270 includes a catheter shaft straightener 278 and a catheter shaft actuator 282. The catheter shaft actuator 282 defines a proximal end section of the tool 270 in the illustrated embodiment, although it may be disposed anywhere along the length of the tool 270 so long as a sufficient length of the catheter shaft straightener 278 extends distally from the catheter shaft actuator 282. The catheter shaft straightener 278 extends distally from a distal end of the catheter shaft actuator 282 to the distal end 272 of the tool 270 in the illustrated embodiment. The catheter shaft straightener 278 may be of any appropriate length.
The catheter shaft straightener 278 may include a flared distal end section 280. An outer diameter of the distal end section 280 may progressively increase proceeding in the direction of the distal end 272 of the multi-function catheter shaft tool 270 (as may the inner diameter of the lumen 276 along the flared distal end section 280). A remainder of the catheter shaft straightener 279 may be of a constant outer diameter (e.g., a smaller outer diameter compared to a maximum outer diameter of the distal end section 280). The distal end section 280 could also be of the same diameter as the remainder of the catheter shaft straightener 278, but could be “softer” than a remainder of the catheter shaft straightener 278 (e.g., for enhanced manipulation of the distal end section 280, for instance when loading a guidewire into a catheter shaft). For instance, a durometer rating of the distal end section 280 (whether flared or not) may be less than a durometer rating of the remainder of the catheter shaft straightener 278 (e.g., the distal end section 280 could have a lower rating on the Shore Hardness Scale compared to a remainder of the catheter shaft straightener 278). The catheter shaft straightener 278 may be formed from any appropriate material or combination of materials, for instance silicone (e.g., to reduce a potential for damaging the electrodes 224 incorporated by the distal end section 222 of the catheter shaft 218).
The catheter shaft actuator 282 may include a grip or engagement section 284 having a larger outer diameter than an outer diameter of the catheter shaft straightener 278, for instance so as to be sufficiently sized for a user to exert a force on the catheter shaft actuator 282 by grasping the engagement section 284. The outer perimeter of the engagement section 284 may include a plurality of circumferentially-spaced segments 284 for facilitating engagement by a user. Any appropriate material or combination of materials may be used to fabricate/form the catheter shaft actuator 282. In one embodiment at least a portion of the catheter shaft actuator 282 is more rigid than the catheter shaft straightener 282 (e.g., at least part of the catheter shaft actuator 282 may have a higher durometer rating than the catheter shaft straightener 278). A distal section 288 of the catheter shaft actuator 282 extends distally from the engagement section 284, and may do so in converging relation to the lumen 276 proceeding in the direction of the catheter shaft straightener 278. In any case, at least part of the catheter shaft straightener 278 extends distally from a distal end of the catheter shaft actuator 282. The catheter shaft straightener 278 and catheter shaft actuator 282 are appropriately interconnected (e.g., fixed or joined) such that the catheter shaft straightener 278 and catheter shaft actuator 282 collectively rotate about a centerline of the lumen 276 (e.g., when torqueing the catheter shaft 218), when advancing the catheter shaft 218 within a patient's vasculature, or both.
The catheter shaft actuator 282 may include an appropriate clamping mechanism that may be actuated between a released configuration and a clamping configuration. For instance, the multi-function catheter shaft tool 270 could include a clamping actuator 390 and clamp 392 of the type discussed below in relation to
The multi-function catheter shaft tool 270 of
The multi-function catheter shaft tool 270 may also be used to torque the catheter shaft 218 and/or to advance the catheter shaft 218 relative to the patient's vasculature. The clamping mechanism of the multi-function catheter shaft tool 270 may be actuated into its released configuration such that the multi-function catheter shaft tool 270 may be advanced along and relative to the catheter shaft 218 to a desired location (e.g., in proximity to the access to the patient's vasculature, whether using a femoral access, a radial access, or any other vasculature access). Thereafter, the clamping mechanism of the multi-function catheter shaft tool 270 may be actuated into its clamping configuration such that the clamping mechanism of the multi-function catheter shaft tool 270 engages an exterior of the catheter shaft 218, where subsequent rotation of the catheter shaft actuator 282 (e.g., about a center line of the lumen 276) will correspondingly rotate the catheter shaft 218 about its length dimension and where advancement of the catheter shaft actuator 282 (e.g., by pushing or pulling on the catheter shaft actuator 282) will correspondingly advance the catheter shaft relative to the patient's vasculature. As the catheter shaft straightener 278 is appropriately fixed relative to the catheter shaft actuator 282, this movement of the catheter shaft actuator 282 will also correspondingly move the catheter shaft straightener 278.
Another embodiment of a multi-function catheter shaft tool is illustrated in
The multi-function catheter shaft tool 290 includes a distal end 294 and a proximal end 296 that are shown in
There are two main components/subassemblies of the multi-function catheter shaft tool 290—a catheter shaft straightener 298 and a catheter shaft actuator 320. Details of the catheter shaft straightener 290 will be addressed in relation to
The catheter shaft straightener 298 includes a liner 300 and an outer housing or tube 310. The liner 300 extends distally beyond a distal end of the outer housing 310, and may include a flared distal end section 302, which may be in accord with the distal end section 280 discussed above. An outer diameter of the distal end section 302 may progressively increase proceeding in the direction of the distal end 294 of the tool 290. A remainder of the liner 300 may be of a constant outer diameter (e.g., a smaller outer diameter compared to a maximum outer diameter of the distal end section 302). The liner 300 may be formed from any appropriate material or combination of materials, for instance silicone (e.g., to reduce a potential for damaging the electrodes 224 incorporated by the distal end section 222 of the catheter shaft 218).
The outer housing or tube 310 of the catheter shaft straightener 298 is disposed circumferentially about the liner 300 along a substantial portion of a length of the liner 300. The distal end of the outer housing 310 may be located adjacent to the flared distal end section 302 of the liner 300. External threads 312 are formed on an exterior of the outer housing 310. These threads 312 may be disposed on a proximal end section of the exterior of the outer housing 310.
A proximal end of the liner 300 may terminate within an interior location along the length of the outer housing 310. In any case, the proximal end of the liner 300 may be appropriately fixed or secured to the clamping section 322 of the catheter shaft actuator 320. At least one deflectable section 324 is incorporated on a proximal end section of the clamping section 322. A pair of deflectable sections 324 are disposed in opposing relation to one another in the illustrated embodiment, with a pair of opposing slots being disposed between this pair of deflectable sections 324. A cover 326 may be disposed over/about the liner 300 and clamping section 322 along their respective lengths.
Each of the liner 300 and the outer housing 310 may be formed from any appropriate material or combination of materials. However, the outer housing 310 may be more rigid than the liner 300 (e.g., for reducing the potential for damage to the electrodes 224 on the distal end section 222 of the catheter shaft 218). For instance, the liner 300 may formed from silicone or other suitably “soft” materials. The outer housing 310 may be characterized as having a first hardness, the liner 300 may be characterized as having a second hardness, with the second hardness being less than the first hardness, and that may facilitate reducing the profile of the distal end section 222 of the catheter shaft 218 while reducing the potential for damaging the electrodes 224 on the distal end section 222 of the catheter shaft 218 while introducing the distal end section 222 into the catheter shaft straightener 298 (e.g., the outer housing 310 may have a higher durometer rating than the liner 300).
A proximal end section of the outer housing 310 of the catheter shaft straightener 298 may be directed into the passage 336 at the distal end 332 of the cap 330 (which also directs at least a proximal end portion of the clamping section 322 of the catheter shaft actuator 320 into this passage 336 as well). Rotation of the cap 330 (catheter shaft actuator 320) relative to the outer housing 310 (catheter shaft straightener 298) engages the interior threads 338 of the cap 330 with the external threads 312 of the outer housing 310, to thereby couple the catheter shaft actuator 280 to the catheter shaft straightener 298. The initial threaded engagement between the cap 330 and the outer housing 310 may allow for coupling of the catheter shaft actuator 320 and the catheter shaft straightener 298 without activating the deflectable sections 324 of the clamping section 322 (e.g., the deflectable sections 324 of the clamping section 322 may be spaced from or otherwise may not be exerting a clamping force on the catheter shaft 218 at this time). This again will be referred to as a “released configuration” for the catheter shaft actuator 320. It should be appreciated that the catheter shaft actuator 320 is also in its released configuration when the cap 330 is not threadably engaged with the outer housing 310. When a threaded engagement has been established between the cap 330 and the outer housing 310, continued rotation of the cap 330 relative to the outer housing 310 will axially advance the cap 330 in the direction of the distal end 294 of the tool 290, which will eventually cause the activating surface 340 of the cap 330 to exert an inwardly-directed force on the deflectable sections 324 of the clamping section 322, so as to dispose the clamping section 322 in the clamping configuration where at least the deflectable sections 324 are clamped against an exterior of the catheter shaft 218.
The multi-function catheter shaft tool 290 of
The multi-function catheter shaft tool 290 may also be used to torque the catheter shaft 218 and/or to advance the catheter shaft 218 relative to the patient's vasculature. The catheter shaft actuator 320 may be actuated into its released configuration such that the multi-function catheter shaft tool 290 may be advanced along and relative to the catheter shaft 218 to a desired location (e.g., in proximity to the access to the patient's vasculature, whether using a femoral access, a radial access, or any other vasculature access). Thereafter, the catheter shaft actuator 320 may be actuated into its clamping configuration such that catheter shaft actuator 320 (more specifically the deflectable sections 324 of its clamping section 322) engages an exterior of the catheter shaft 218. At this time, rotation of the catheter shaft actuator 320 (e.g., about a centerline of the lumen 292) will correspondingly rotate the catheter shaft 218 about its length dimension. As the catheter shaft straightener 298 is appropriately fixed relative to the catheter shaft actuator 320, this rotation of the catheter shaft actuator 320 will also correspondingly rotate the catheter shaft straightener 298. Advancement of the catheter shaft actuator 320 (e.g., by pushing or pulling on the catheter shaft actuator 320) will advance the catheter shaft 218 relative to the patient's vasculature in a corresponding direction (and will similarly advance the catheter shaft straightener 298).
An embodiment of a catheter assembly is illustrated in
The catheter 360 includes a handle 362 and a catheter shaft 364 that extends distally from a distal end of the catheter handle 362. The catheter shaft 364 may extend at least into the distal end of the catheter shaft handle 362, and the catheter shaft handle 362 may engage the catheter shaft 364 in a manner that allows the catheter shaft handle 362 to be used to move the catheter shaft 364 (e.g., torque and/or advance the catheter shaft 364 relative to the patient's vasculature) in a manner that will be discussed in more detail below (e.g. the catheter shaft 364 may be appropriately anchored/fixed relative to the catheter handle 362). A generator connector 366 extends from a proximal end of the catheter handle 360.
The catheter shaft actuator 370 includes a body 372 having a distal end 374 and a proximal end 376 that are spaced from one another along a length dimension of the body 372. As the body 372 may be used to move the catheter shaft 218 in a manner that will be discussed in more detail below, the body 372 may also be referred to as a “catheter shaft actuator 372.” The body 372 may be fabricated in any manner, for instance in separate halves.
An annular first tube 394 extends from the distal end 374 of the body 372. This first tube 394 may be used to reduce the potential for kinking of the catheter shaft 218 when being torqued and/or advanced (e.g., relative to the patient's vasculature) by the catheter shaft actuator 370. An annular second tube 398 extends from the proximal end 376 of the body 372. The first tube 394 includes an annular first lumen 396 that extends to a passage defined by an annular first cylindrical section 380 within the interior of the body 372. The second tube 398 includes an annular second lumen 400 that extends to a passage defined by an annular second cylindrical section 382 within the interior of the body 372. The first cylindrical section 380 and the second cylindrical section 382 are axially aligned but are spaced from one another within the interior of the body 372. A clamp 392 is disposed in the space between the first cylindrical section 380 and the second cylindrical section 382 within the interior of the body 372. An actuator 390 is disposed on an exterior of the body 372 and is movable between first and second positions to dispose the clamp in a released configuration and a clamping configuration, respectively. As such, the actuator 390 may also be referred to as a “clamping actuator 390.”
Disposing the clamping actuator 390 in its released configuration (by movement of the actuator 390, to produce a corresponding movement of the clamp 392) allows the catheter shaft actuator 370 to be advanced along and relative to the catheter shaft 364 to a desired location (e.g., in proximity to the access to the patient's vasculature, whether using a femoral access, a radial access, or any other vasculature access). Disposing the clamping actuator 390 in its clamping configuration (by movement of the actuator 390, to produce a corresponding movement of the clamp 392) causes the clamp 392 to engage an exterior of the catheter shaft 364 such that rotation of the catheter shaft actuator 370 (e.g., by engagement of the body 372) will correspondingly rotate the catheter shaft 364 about its length dimension, and such that advancement of the catheter shaft actuator 370 (e.g., by engagement of and pushing or pulling on the body 372) will advance the catheter shaft 364 along the patient's vasculature in the corresponding direction. The noted “rotation” may be described as being about a centerline through the first lumen 396 of the first tube 394, the passage defined by the first cylindrical section 380, the passage defined by the second cylindrical section 382, and the second lumen 400 of the second tube 398.
The catheter shaft actuator 370 may be disposed such that its second tube 398 extends within the distal end of the catheter handle 362 and as shown in
The clamping actuator 390 may be disposed in its released configuration (by movement of the actuator 390, to produce a corresponding movement of the clamp 392) such that the catheter shaft actuator 370 may be advanced distally along the catheter shaft 364, to thereby position the catheter shaft actuator 370 closer to the vasculature access being utilized and where the catheter shaft actuator 370 is now spaced from the catheter handle 362, for instance as shown in
Another embodiment of a catheter assembly is illustrated in
The catheter 420 may be of any appropriate type/configuration and may provide any appropriate function or combination of functions when disposed in a patient's vasculature (e.g., diagnostic, therapeutic, neuromodulation, denervation). The catheter 420 includes an electrical housing 422 and a catheter shaft 436 that extends distally from a distal end of the electrical housing 422. The catheter shaft 436 may extend at least into the distal end of the electrical housing 422. A generator cable 434 extends proximally from a proximal end of the electrical housing 422.
The electrical housing 422 may be defined by a pair of housing sections 424 that are appropriately interconnected. A printed circuit board 432 is enclosed within the electrical housing 422. The printed circuit board 432 may include one or more bonding pads to provide an electrical/operative connection between the wires for any electrodes or other electrical components incorporated by the catheter shaft 436 (e.g., electrodes 224) and the generator cable 434. Any appropriate structure for providing an electrical/operative connection between the wires for the electrodes/electrical components of the catheter shaft 436 and the generator cable 434 may be utilized by the electrical housing 422.
In the case of the catheter assembly 410, the electrical housing 422 is not in the form of a traditional catheter handle. Instead the primary function of the electrical housing 422 is to enclose the printed circuit board 432 (or more generally the structure for providing an electrical/operative connection between the wires 226 for the electrodes 224 and the generator cable 434). The electrical housing 422 is subject to a number of characterizations in this regard. One is that the exterior of the housing 422 is not ergonomically shaped. Another is that a maximum outer diameter of the housing 422 (taken perpendicular to its length dimension) is reduced compared to typical catheter handles. In the illustrated embodiment, the housing 422 includes a cylindrical section 426, a distal end section 428, and a proximal end section 430, with the cylindrical section 426 being disposed between the distal end section 428 and the proximal end section 430, and with the distal end section 428 and the proximal end section 430 being spaced from one another along a length dimension of the housing 422. The distal end section 428 converges toward a centerline through the housing 422 (corresponding with the length dimension of the housing 422) proceeding in the distal direction from the cylindrical section 426. Similarly, the proximal end section 430 converges toward the centerline through the housing 422 proceeding in the proximal direction from the cylindrical section 426.
The catheter shaft actuator 440 is positioned on the distal side of the housing 422, includes a housing 442, an actuator 444, and a clamp 446, and provides the primary structure for moving the catheter shaft 436 in the case of the catheter assembly 410. The housing 442 includes a proximal housing section 442a and a distal housing section 442b. The distal housing section 442b incorporates the actuator 444 and the clamp 446. A user may grasp the proximal housing section 442a to move the catheter shaft 436 in the desired manner. As such, the proximal housing section 442a may also be referred to as a “catheter shaft actuator 442a.”
The actuator 444 is disposed on an exterior of the catheter shaft actuator 440 and is movable between first and second positions to dispose the clamp 446 in a released configuration and a clamping configuration, respectively. As such, the actuator 444 may also be referred to as a “clamping actuator 444.” Disposing the clamping actuator 444 in its released configuration (by movement of the actuator 444, to produce a corresponding movement of the clamp 446) allows the catheter shaft actuator 440 to be advanced along and relative to the catheter shaft 436 to a desired location (e.g., in proximity to the access to the patient's vasculature, whether using a femoral access, a radial access, or any other vasculature access). Disposing the clamping actuator 444 in its clamping configuration (by movement of the clamping actuator 444, to produce a corresponding movement of the clamp 446) allows the clamping actuator 444 (more specifically the clamp 446) to engage an exterior of the catheter shaft 436 such that rotation of the catheter shaft actuator 440 (e.g., about a centerline coinciding with a length dimension of the catheter shaft actuator 440, which coincides with the length of the catheter shaft 436 extending through the catheter shaft actuator) will correspondingly rotate the catheter shaft 436 about its length dimension, and such that advancement of the catheter shaft actuator 440 (e.g., by engagement of and pushing or pulling on the catheter shaft actuator 440) will advance the catheter shaft 436 along the patient's vasculature in the corresponding direction. Generally, the catheter shaft actuator 440 may be moved to any position along the catheter shaft 436 that is desired by the user, and thereafter with the clamping actuator 444 being in its clamped configuration, a user may engage the catheter shaft actuator 440 to exert a desired force or combination of forces on the catheter shaft 436 in the manner described herein and to yield a desired movement or combination of movements of the catheter shaft 436.
Another embodiment of a catheter assembly is illustrated in
The catheter 460 may be of any appropriate type/configuration and may provide any appropriate function or combination of functions when disposed in a patient's vasculature (e.g., diagnostic, therapeutic, neuromodulation, denervation). The catheter 460 includes a catheter handle 462 and a catheter shaft 470 that extends distally from a distal end of the catheter handle 462. The catheter shaft 470 may extend at least into the distal end of the catheter handle 462, and may be of any appropriate configuration (e.g., in accord with the above-discussed catheter shaft 218). The catheter shaft 470 may be appropriately anchored/fixed relative to the catheter handle 462 to allow the catheter handle 462 to be used to torque the catheter shaft 470 (e.g., in the
The catheter handle 462 may be defined by a pair of handle sections 464 that are appropriately interconnected (only one handle section 464 being shown in
The distal housing section 442b of the catheter shaft actuator 440 is disposed distally of the catheter handle 462 and the proximal housing section 442a is disposed within the catheter handle 462 in the
Features may be incorporated to detachably connect the catheter handle 462 and the catheter shaft actuator 470, for instance when in the
The foregoing description of the present invention has been presented for purposes of illustration and description. Furthermore, the description is not intended to limit the invention to the form disclosed herein. Consequently, variations and modifications commensurate with the above teachings, and skill and knowledge of the relevant art, are within the scope of the present invention. The embodiments described hereinabove are further intended to explain best modes known of practicing the invention and to enable others skilled in the art to utilize the invention in such, or other embodiments and with various modifications required by the particular application(s) or use(s) of the present invention. It is intended that the appended claims be construed to include alternative embodiments to the extent permitted by the prior art.
Any feature of any other various aspects addressed in this disclosure that is intended to be limited to a “singular” context or the like will be clearly set forth herein by terms such as “only,” “single,” “limited to,” or the like. Merely introducing a feature in accordance with commonly accepted antecedent basis practice does not limit the corresponding feature to the singular. Moreover, any failure to use phrases such as “at least one” also does not limit the corresponding feature to the singular. Use of the phrase “at least substantially,” “at least generally,” or the like in relation to a particular feature encompasses the corresponding characteristic and insubstantial variations thereof (e.g., indicating that a surface is at least substantially or at least generally flat encompasses the surface actually being flat and insubstantial variations thereof). Finally, a reference of a feature in conjunction with the phrase “in one embodiment” does not limit the use of the feature to a single embodiment.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2022/061010 | 4/26/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63179895 | Apr 2021 | US |
