Patent Grant
10549127
The present disclosure relates generally to methods and apparatuses for nerve modulation techniques such as ablation of nerve tissue or other modulation techniques through the walls of blood vessels.
Certain treatments may require the temporary or permanent interruption or modification of select nerve function. One example treatment is renal nerve ablation, which is sometimes used to treat conditions related to congestive heart failure or hypertension. The kidneys produce a sympathetic response to congestive heart failure, which, among other effects, increases the undesired retention of water and/or sodium. Ablating some of the nerves running to the kidneys may reduce or eliminate this sympathetic function, which may provide a corresponding reduction in the associated undesired symptoms.
Many nerves (and nervous tissue such as brain tissue), including renal nerves, run along the walls of or in close proximity to blood vessels and thus can be accessed intravascularly through the walls of the blood vessels. In some instances, it may be desirable to ablate perivascular nerves using ultrasonic energy. In other instances, the perivascular nerves may be ablated by other means including application of thermal, radiofrequency, laser, microwave, and other related energy sources to the target region. Ultrasound transducers may dissipate some energy as heat into the blood and surrounding tissue as well as causing the ultrasound transducers to become hot. This may result in blood damage, clotting, and/or protein fouling of the transducer among other undesirable side effects. In some instances, overheating of the ultrasound transducer may result in the failure of the transducers. It may be desirable to provide for alternative systems and methods for intravascular nerve modulation with increased cooling of the transducers.
This disclosure is directed to several alternative designs, materials and methods of manufacturing medical device structures and assemblies for performing nerve ablation.
Accordingly, one illustrative embodiment is a system for intravascular nerve modulation system that may include an elongated shaft having a proximal end region and a distal end region. A bar element configured to vibrate at a low frequency may extend distally from the distal end region of the elongated shaft. A proximal end of the bar element may be attached to the distal end of the elongated shaft such that the distal end of the bar element is free to vibrate. When subjected to a first frequency, the bar element may vibrate. One or more ablation transducers configured to operate at a second frequency may be affixed to the bar element. Another illustrative embodiment is an intravascular nerve modulation system that may include a catheter shaft having a proximal end region, a distal end region, and a lumen extending therebetween. The system may further include an elongated shaft disposed within the lumen of the catheter shaft and having a proximal end region and a distal end region. A driver may be connected to the proximal end region of the elongated shaft. One or more ablation transducers may be secured to a distal end region of the elongated shaft.
Another illustrative embodiment is an intravascular nerve modulation system that may include a catheter shaft having a proximal end region, a distal end region, and a lumen extending therebetween. The modulation system may further include a bar element and a tension member positioned adjacent to the distal end region of the catheter shaft. One or more ablation transducers may be secured to a distal end region of the bar element. The bar element may be connected to a control unit.
The above summary of an example embodiment is not intended to describe each disclosed embodiment or every implementation of the present disclosure.
The invention may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying drawings, in which:
While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit aspects of the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.
For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.
All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the terms “about” may be indicative as including numbers that are rounded to the nearest significant figure.
The recitation of numerical ranges by endpoints includes all numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).
Although some suitable dimensions ranges and/or values pertaining to various components, features and/or specifications are disclosed, one of the skill in the art, incited by the present disclosure, would understand desired dimensions, ranges and/or values may deviate from those expressly disclosed.
As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
For purposes of this disclosure, “proximal” refers to the end closer to the device operator during use, and “distal” refers to the end further from the device operator during use.
The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The detailed description and the drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the disclosure. The illustrative embodiments depicted are intended only as exemplary. Selected features of any illustrative embodiment may be incorporated into an additional embodiment unless clearly stated to the contrary.
It is noted that references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with one embodiment, it should be understood that such feature, structure, or characteristic may also be used connection with other embodiments whether or not explicitly described unless cleared stated to the contrary.
Certain treatments require the temporary or permanent interruption or modification of select nerve function. One example treatment is renal nerve ablation, which is sometimes used to treat conditions related to congestive heart failure or hypertension. The kidneys produce a sympathetic response to congestive heart failure, which, among other effects, increases the undesired retention of water and/or sodium. Ablating some of the nerves running to the kidneys may reduce or eliminate this sympathetic function, which may provide a corresponding reduction in the associated undesired symptoms.
While the devices and methods described herein are discussed relative to renal nerve modulation, it is contemplated that the devices and methods may be used in other locations and/or applications where nerve modulation and/or other tissue modulation including heating, activation, blocking, disrupting, or ablation are desired, such as, but not limited to: blood vessels, urinary vessels, or in other tissues via trocar and cannula access. For example, the devices and methods described herein can be applied to hyperplastic tissue ablation, tumor ablation, benign prostatic hyperplasia therapy, nerve excitation or blocking or ablation, modulation of muscle activity, hyperthermia or other warming of tissues, etc. In some instances, it may be desirable to ablate perivascular renal nerves with ultrasound ablation.
Ultrasound energy may be used to generate heat at a target location. The high frequency sound waves produced by an ultrasonic transducer may be directed at a target region and absorbed at the target region. As the energy emitted is absorbed, the temperature of the target region may rise. In order to perform renal nerve ablation, target nerves must be heated sufficiently to make them nonfunctional, while thermal injury to the artery wall is undesirable. Heating of the artery wall may also increase pain during the procedure, which is also undesirable. When a portion of tissue is ablated, tissue properties change and increased attenuation of the ultrasound energy can make ablation past this ablated tissue difficult. Ultrasound ablation catheters may also generate significant heat in the ultrasound transducers may cause clots to form on the transducers, damage to the blood, or damage to the transducers among other undesirable side effects. As the ablation transducers heat, the energy conversion efficiency of those devices is lowered, thus generating more heat. Thus, normal operations of ablation transducers may be characterized by increasingly lower efficiency during operation. The efficiency of the ablation transducers may be enhanced using a cooling mechanism. One possible cooling mechanism is increasing the flow of blood past the transducers, providing passive cooling to the ablation transducers. In some instances, this may be accomplished by moving the ablation transducers back and forth in the blood thus increasing heat transfer to the blood and mixing of the blood. This may facilitate cooling of the transducers and/or reduce build-up of clots or other proteins.
The system 100 may include an array of ultrasound ablation transducers 110 positioned adjacent the distal end region 104 of the elongate shaft. However, the transducer array 110 may be placed at any longitudinal location along the elongate shaft 102 desired. It is contemplated that the array may include any number of transducers 110 desired. It is further contemplated that more than one row of transducers 110 may be disposed on the elongate shaft 102. In some instances, the ablation transducers 110 may include a number of transducers (two, three, four, or more) spaced about the circumference of the elongate shaft 102. This may allow for ablation of multiple circumferential locations about the body lumen simultaneously. In other embodiments, the transducers 110 may comprise a focused or phased array of transducers. The array may be configured to be directed at a focus region such that multiple transducers are radiating energy at a common target region. It is further contemplated that the ablation transducers 110 may comprise a plurality of longitudinally spaced transducers.
The ablation transducers 110 may be formed from any suitable material such as, but not limited to, lead zirconate titanate (PZT). It is contemplated that other ceramic or piezoelectric materials may also be used. While not explicitly shown, the ablation transducers 110 may have a first radiating surface, a second radiating surface, and a perimeter surface extending around the outer edge of the ablation transducer 110. In some instances, the transducers 110 may include a layer of gold, or other conductive layer, disposed on the first and/or second side over the PZT crystal for connecting electrical leads to the transducers 110. In some embodiments, the ablation transducers 110 may be structured to radiate acoustic energy from a single radiating surface. In such an instance, one radiating surface may include a backing layer to direct the acoustic energy in a single direction. In other embodiments, the ablation transducers 110 may be structured to radiate acoustic energy from two radiating surfaces. In some instances, one or more tie layers may be used to bond the gold to the PZT. For example, a layer of chrome may be disposed between the PZT and the gold to improve adhesion. In other instances, the transducers 110 may include a layer of chrome over the PZT followed by a layer of nickel, and finally a layer of gold. These are just examples. It is contemplated that the layers may be deposited on the PZT using sputter coating, although other deposition techniques may be used as desired. While the ablation transducers 110 are described as ultrasonic transducers, it is contemplated that other methods and devices for raising the temperature of the nerves may be used, such as, but not limited to: radiofrequency, microwave, or other acoustic, optical, electrical current, direct contact heating, or other heating.
It is contemplated that the radiating surface (surface which radiates acoustic energy) of the transducers 110 may take any shape desired, such as, but not limited to, square, rectangular, polygonal, circular, oblong, etc. The acoustic energy from the radiating surface of the transducers 110 may be transmitted in a spatial pressure distribution related to the shape of the transducers 110. With exposures of appropriate power and duration, lesions formed during ablation may take a shape similar to the contours of the pressure distribution. As used herein, a “lesion” may be a change in tissue structure or function due to injury (e.g. tissue damage caused by the ultrasound). Thus, the shape and dimensions of the transducers 110 may be selected based on the desired treatment and the shape best suited for that treatment. It is contemplated that the transducers 110 may also be sized according to the desired treatment region. For example, in renal applications, the transducers 110 may be sized to be compatible with a 6 French guide catheter, although this is not required.
In some embodiments, the transducers 110 may be formed of a separate structure and attached to the elongate shaft 102. For example, the transducers 110 may be bonded or otherwise attached to the elongate shaft 102. In some instances, the transducers 110 may include a ring or other retaining or holding mechanism (not explicitly shown) disposed around the perimeter of the transducers 110 to facilitate attachment of the transducers 110. The transducers 110 may further include a post, or other like mechanism, affixed to the ring such that the post may be attached to the elongate shaft 102 or other member. In some instances, the rings may be attached to the transducers 110 with a flexible adhesive, such as, but not limited to, silicone. However, it is contemplated that the rings may be attached to the transducers 110 in any manner desired. While not explicitly shown, in some instances, the elongate shaft 102 may be formed with grooves or recesses in an outer surface thereof. The recesses may be sized and shaped to receive the transducers 110. For example, the ablation transducers 110 may be disposed within the recess such that a first surface contacts the outer surface of the elongate shaft 102 and a second surface is directed towards a desired treatment region. However, it is contemplated that the transducers 110 may be affixed to the elongate shaft in any manner desired.
In some embodiments, the transducers 110 may be affixed to an outer surface of the elongate shaft 102 such that the surfaces of the transducers 110 are exposed to blood flow through the vessel. As the power is relayed to the ablation transducers 110, the power that does not go into generating acoustic power generates heat. As the ablation transducers 110 heat, they become less efficient, thus generating more heat. Passive cooling provided by the flow of blood may help improve the efficiency of the transducers 110. However, in some instances, additional cooling may be provided by introducing a cooling fluid or other cooling mechanism to the modulation system 100.
While not explicitly shown, the ablation transducers 110 may be connected to a control unit (such as control unit 18 in
It is contemplated that the modulation system 100 may be configured to operate in an ablation mode and a low frequency mode. In the low frequency mode, the system 100 may be operated at a first, lower frequency with a higher amplitude. It is contemplated that the low frequency may range from about 10 KHz to 200 KHz. It is further contemplated that the first frequency may include various other frequency ranges, as desired, based upon the physical affects produced. This may allow the distal end region 104 of the elongate shaft 102 to shake, vibrate, or otherwise move back and forth as shown by arrows 114 in
Once the modulation system 100 has been advanced to the treatment region, energy may be supplied to the ablation transducers 110. In some instances, the transducers 110 may function as both the high frequency and low frequency transducers and may be alternately activated in a high frequency ablation mode and a low frequency “shaking” mode. In other embodiments, separate transducers may be supplied that are tuned to different frequencies. For example, while not explicitly shown, a first set of transducers may be tuned to be excitable at a high frequency to perform tissue modulation and/or ablation and a second set of transducers may be tuned to be excitable at a low frequency to perform intermittent shaking. It is contemplated that the high frequency transducers and the low frequency transducers may be operated in an alternating manner or simultaneously, as desired. It is further contemplated that the transducers 110 may be placed at various angles to improve the effectiveness of convective cooling. Additionally, the elongate shaft 102 may include structure or features, such as vanes, to improve the effectiveness of convective cooling.
The modulation system 100 may be advanced through the vasculature in any manner known in the art. For example, system 100 may include a guidewire lumen to allow the system 100 to be advanced over a previously located guidewire. In some embodiments, the modulation system 100 may be advanced, or partially advanced, within a guide sheath such as the sheath 16 shown in
Once the modulation system 100 has been advanced to the treatment region, energy may be supplied to the ablation transducers 110. As discussed above, the energy may be supplied to both the ablation transducers 110 and the shaking transducers, if so provided, simultaneously or in an alternating fashion as desired or the transducers 110 may be alternately activated at a high frequency and a low frequency. The amount of energy delivered to the ablation transducers 110 may be determined by the desired treatment as well as the feedback provided by monitoring systems.
In some instances, the elongate shaft 102 may be rotated and additional ablation can be performed at multiple locations around the circumference of the vessel 106. In some instances, a slow automated “rotisserie” rotation can be used to work around the circumference of the vessel 106, or a faster spinning can be used to simultaneously ablate around the entire circumference. The spinning can be accomplished with a distal micro-motor or by spinning a drive shaft from the proximal end. In some embodiments, ultrasound sensor information can be used to selectively turn on and off the ablation transducers to warm any cool spots or accommodate for veins, or other tissue variations. The number of times the elongate shaft 102 is rotated at a given longitudinal location may be determined by the number and size of the ablation transducers 110 on the elongate shaft 102. Once a particular location has been ablated, it may be desirable to perform further ablation procedures at different longitudinal locations. Once the elongate shaft 102 has been longitudinally repositioned, energy may once again be delivered to the ablation transducers 110. If necessary, the elongate shaft 102 may be rotated to perform ablation around the circumference of the vessel 106 at each longitudinal location. This process may be repeated at any number of longitudinal locations desired. It is contemplated that in some embodiments, the system 100 may include transducer arrays 110 at various positions along the length of the modulation system 100 such that a larger region may be treated without longitudinal displacement of the elongate shaft 102.
The elongated shaft 202 may have a long, thin, flexible tubular configuration. A person skilled in the art will appreciate that other suitable configurations such as, but not limited to, rectangular, oval, irregular, or the like may also be contemplated. In addition, the elongated shaft 202 may have a cross-sectional configuration adapted to be received in a desired vessel, such as a renal artery. For instance, the elongated shaft 202 may be specially sized and configured to accommodate passage through the intravascular path, which leads from a percutaneous access site in, for example, the femoral, brachial, or radial artery, to a targeted treatment site, for example, within a renal artery.
It is contemplated that the stiffness of the elongated shaft 202 may be modified to form modulation system 200 for use in various vessel diameters. To this end, the material used for manufacturing the elongated shaft 202 may include any suitable biocompatible material such as, but are not limited to, polymers, metals, alloys, either in combination or alone. The material employed may have enough stiffness for use in various lumen diameters, and sufficient flexibility to maneuver through tortuous and/or stenotic lumens, avoiding any undesirable tissue injuries.
The elongated shaft 202 may further include one or more lumens (not explicitly shown) extending therethrough. For example, the elongated shaft 202 may include a guidewire lumen and/or one or more auxiliary lumens. The lumens may have a variety of configurations and/or arrangements. For example, the guidewire lumen may extend the entire length of the elongated shaft 202 such as in an over-the-wire catheter or may extend only along a distal portion of the elongated shaft 202 such as in a single operator exchange (SOE) catheter. These examples are not intended to be limiting, but rather examples of some optional configurations. While not explicitly shown, the modulation system 200 may further include temperature sensor/wire, an infusion lumen, radiopaque marker bands, fixed guidewire tip, a guidewire lumen, external sheath, and/or other components to facilitate the use and advancement of the system 200 within the vasculature. It is further contemplated that the modulation system 200 may include one or more centering baskets, expandable framework, and/or expandable balloons to center or otherwise position the modulation system 200 within the body lumen.
The system 200 may further include a bar element 204 having a proximal end region 212 and a distal end region 214. In some embodiments, the bar element 204 may include a long, thin bar-shaped transducer disposed adjacent the distal end region 210 of the elongate shaft 202. It may be contemplated that other suitable shapes such as, but limited to rectangular, square, cylindrical, oval, irregular, and so forth may be used, as desired. In some instances, the bar element 204 may be attached to the distal end region of the elongated shaft 202 such that the proximal end region 212 is physically constrained. The distal end region 214 of the bar element may be unconstrained.
In some embodiments, the bar element 204 may be may be formed from any suitable material such as, but not limited to, lead zirconate titanate (PZT). It is contemplated that other ceramic or piezoelectric materials, such as, but not limited to barium titanate, may also be used. In some instances, the bar element 204 may include a layer of gold, or other conductive layer, disposed on a first and/or second side surface over the PZT crystal for connecting electrical leads to the bar element 204. In some instances, one or more tie layers may be used to bond the gold to the PZT. For example, a layer of chrome may be disposed between the PZT and the gold to improve adhesion. In other instances, the bar element 204 may include a layer of chrome over the PZT followed by a layer of nickel, and finally a layer of gold. These are just examples. It is contemplated that the layers may be deposited on the PZT using sputter coating, although other deposition techniques may be used as desired.
In some embodiments, the proximal end region 212 of the bar element 204 may connected to the distal end region 210 of the elongated shaft 202 via a connecting member 206. Exemplary connecting members 206 may include structures such as, but not limited to, male-female connections, friction-fit, threading, luer-connections, clamping mechanisms, and so forth. In one embodiment, the connecting member 206 may include a clamp (not explicitly shown), which may be fixedly secured to the distal end region 210 of the elongated shaft at a proximal end and coupled to the proximal end region 212 of the bar element 204 at a distal end thereof. In some embodiments, the bar element 204 may include a ring or other retaining or holding mechanism (not explicitly shown) disposed around the perimeter of the bar element 204 to facilitate attachment of the bar element 204. The bar element 204 may further include a post, or similar mechanism, affixed to the ring such that the post may be attached to the elongated shaft 202 or other member. Those skilled in the art will appreciate that various other suitable connection mechanisms may be used couple the bar element 204 to the distal end region 210 of the elongated shaft 202. Alternatively, the bar element 204 may be formed of a separate structure and may be directly attached to the distal end region 210 of the elongated shaft 202. While the proximal end region 212 of the bar element 204 may be attached to the distal end region 210, the distal end region 214 of the bar element 204 may remain free, or unconstrained, forming a cantilever extending distally from the end region 210.
The system 200 may further include one or more ablation transducers 208 mounted on the bar element 204. While the Figure illustrates four ablation transducers 208, it is contemplated that the modulation system 200 may include any number of ablation transducers desired, such as, but not limited to, one, two, three, or more. In some instances, the ablation transducers 208 may include a number of transducers (two, three, four, or more) spaced about the circumference of the bar element 204. This may allow for ablation of multiple circumferential locations about the body lumen simultaneously. In other embodiments, the ablation transducers 208 may comprise a focused or phased array of transducers. The array may be configured to be directed at a focus region such that multiple transducers are radiating energy at a common target region. It is further contemplated that the ablation transducers 208 may comprise a plurality of longitudinally spaced transducers.
While the ablation transducers 208 are described as ultrasonic transducers, it is contemplated that other methods and devices for raising the temperature of the nerves may be used, such as, but not limited to: radiofrequency, microwave, or other acoustic, optical, electrical current, direct contact heating, or other heating. The same may also be true of bar element 204. The ablation transducers 208 may be formed from any suitable material such as, but not limited to, lead zirconate titanate (PZT). It is contemplated that other ceramic or piezoelectric materials may also be used. While not explicitly shown, the ablation transducers 208 may have a first radiating surface, a second radiating surface, and a perimeter surface extending around the outer edge of the ablation transducers 208. In some instances, the ablation transducers 208 may include a layer of gold, or other conductive layer, disposed on the first and/or second side over the PZT crystal for connecting electrical leads to the ablation transducers 208. In some embodiments, the ablation transducers 208 may be structured to radiate acoustic energy from a single radiating surface. In such an instance, one radiating surface may include a backing layer to direct the acoustic energy in a single direction. In other embodiments, the ablation transducers 208 may be structured to radiate acoustic energy from two radiating surfaces. In some instances, one or more tie layers may be used to bond the gold to the PZT. For example, a layer of chrome may be disposed between the PZT and the gold to improve adhesion. In other instances, the transducers 208 may include a layer of chrome over the PZT followed by a layer of nickel, and finally a layer of gold. These are just examples. It is contemplated that the layers may be deposited on the PZT using sputter coating, although other deposition techniques may be used as desired.
It is contemplated that the radiating surface (surface which radiates acoustic energy) of the ablation transducers 208 may take any shape desired, such as, but not limited to, square, rectangular, polygonal, circular, oblong, etc. The acoustic energy from the radiating surface of the ablation transducers 208 may be transmitted in a spatial pressure distribution related to the shape of the ablation transducers 208. With exposures of appropriate power and duration, lesions formed during ablation may take a shape similar to the contours of the pressure distribution. As used herein, a “lesion” may be a change in tissue structure or function due to injury (e.g. tissue damage caused by the ultrasound). Thus, the shape and dimensions of the ablation transducers 208 may be selected based on the desired treatment and the shape best suited for that treatment. It is contemplated that the ablation transducers 208 may also be sized according to the desired treatment region. For example, in renal applications, the ablation transducers 208 may be sized to be compatible with a 6 French guide catheter, although this is not required.
In some embodiments, the ablation transducers 208 may be formed of a separate structure and attached to the bar element 204. For example, the ablation transducers 208 may be bonded or otherwise attached to the bar element 204. In some instances, the ablation transducers 208 may include a ring or other retaining or holding mechanism (not explicitly shown) disposed around the perimeter of the ablation transducers 208 to facilitate attachment of the ablation transducers 208. The ablation transducers 208 may further include a post, or other like mechanism, affixed to the ring such that the post may be attached to the bar element 204 or other member. In some instances, the rings may be attached to the ablation transducers 208 with a flexible adhesive, such as, but not limited to, silicone. However, it is contemplated that the rings may be attached to the ablation transducers 208 in any manner desired. While not explicitly shown, in some instances, the bar element 204 may be formed with grooves or recesses in an outer surface thereof. The recesses may be sized and shaped to receive the ablation transducers 208. For example, the ablation transducers 208 may be disposed within the recess such that a first radiating surface contacts the outer surface of the bar element 204 and a second radiating surface is directed towards a desired treatment region. However, it is contemplated that the ablation transducers 208 may be affixed to the bar element 204 in any manner desired. It is further contemplated that in some instances, the ablation transducers 208 may be affixed adjacent the distal end region 210 of the elongate shaft 202, or along any longitudinal length thereof, as desired.
The ablation transducers 208 may be connected to a control unit (such as control unit 18 in
The bar element 204 may also be connected to a control unit (such as control unit 18 in
The modulation system 200 may be configured to operate at a first frequency for causing physical movement of the bar element 204 and a second frequency for performing tissue modulation using the ablation transducers 208. Here, the first frequency may include a low frequency that may provide physical movement to the bar element 204, thus providing cooling to the ablation transducers 208, as discussed above. It is contemplated that the first frequency may range from about 10 KHz to 200 KHz. It is further contemplated that the first frequency may include various other frequency ranges, as desired, based upon the physical affects produced. The second frequency may include a high frequency, which may ablate the target tissue. The second frequency may range from about 9-10 megahertz (MHz). It is contemplated that any desired frequency may be used, for example, from 1-20 MHz beyond. In general, the second frequency may be higher than the first frequency. The reverse configuration may also be utilized.
In addition, while ablation transducers 208 are shown in
As discussed above, the bar element 204 and the ablation transducers 208 may be connected to one or more control units, which may provide and/or monitor the system 200 with one or more parameters such as, but not limited to, frequency for performing the desired ablation procedure. In some embodiments, the control unit may include an oscillator. More specifically, the oscillator may have a predetermined range of frequencies such as the first frequency and the second frequency (as previously discussed). Exemplary oscillators may include a mechanical oscillator, acoustic oscillator, or other suitable oscillators known to those skilled in the art. Those skilled in the art, however, will appreciate that any other suitable control unit and/or energy source may also be contemplated.
The modulation system 200 may be advanced through the vasculature in any manner known in the art. For example, system 200 may include a guidewire lumen to allow the system 200 to be advanced over a previously located guidewire. In some embodiments, the modulation system 200 may be advanced, or partially advanced, within a guide sheath such as the sheath 16 shown in
Once the modulation system 200 has been advanced to the treatment region, energy may be supplied to the ablation transducers 208 and the bar element 204. In some instances, energy may first be supplied to the ablation transducers 208. As the energy is radiated from the ablation transducers 208, the ablation transducers 208 may begin to heat. The modulation system 200 may use temperature sensors, or the monitoring means, to monitor the temperature or efficiency of the ablation transducers 208. Once the ablation transducers 208 have reached a predetermined criteria, energy may then be supplied to the bar element 204. As discussed above, the energy supplied to the bar element 204 may result in physical movement of the bar element, and thus the ablation transducers 208. As the bar element 204 moves, increased convection may transfer heat away from the ablation transducers 208. It is contemplated that energy may be supplied to the ablation transducers 208 and the bar element 204 in an alternating fashion such that one is activated while the other is inactive. In other embodiments, the ablation transducers 208 and the bar element 204 may be activated simultaneously. The amount of energy delivered to the ablation transducers 208 may be determined by the desired treatment as well as the feedback provided by the system 200.
In some instances, the elongated shaft 202 may be rotated and additional ablation can be performed at multiple locations around the circumference of the vessel. In some instances, a slow automated “rotisserie” rotation can be used to work around the circumference of the vessel, or a faster spinning can be used to simultaneously ablate around the entire circumference. The spinning can be accomplished with a micro-motor or by spinning a drive shaft. In some embodiments, ultrasound sensor information can be used to selectively turn on and off the ablation transducers 208 to warm any cool spots or accommodate for veins, or other tissue variations. The number of times the elongated shaft 202 is rotated at a given longitudinal location may be determined by the number and size of the ablation transducers 208 on the bar element 204. Once a particular location has been ablated, it may be desirable to perform further ablation procedures at different longitudinal locations. Once the elongated shaft 202 has been longitudinally repositioned, energy may once again be delivered to the ablation transducers 208 and the bar element 204. If necessary, the elongated shaft 202 may be rotated to perform ablation around the circumference of the vessel at each longitudinal location. This process may be repeated at any number of longitudinal locations desired. It is contemplated that in some embodiments, the system 200 may include ablation transducers at various positions along the length of the modulation system 200 such that a larger region may be treated without longitudinal displacement of the elongated shaft 202.
In addition, the catheter shaft 304 may have a cross-sectional configuration adapted to be received in a desired vessel, such as a renal artery. For instance, the catheter shaft 304 may specially be sized and configured to accommodate passage through the intravascular path, which leads from a percutaneous access site in, for example, the femoral, brachial, or radial artery, to a targeted treatment site, for example, within a renal artery. An exemplary embodiment may depict the catheter shaft 304 to take on a long, thin, flexible tube-shaped structure having a tubular cross-section; however, other contemplated cross-sections may include rectangular, irregular, or other suitable structures known to those skilled in the art.
The catheter shaft 304 may further include one or more lumens (not explicitly shown) in addition to lumen 308 extending therethrough. For example, the catheter shaft 304 may include a guidewire lumen and/or one or more auxiliary lumens. The lumens may be configured in any suitable way such as those ways commonly used for medical device. For example, the guidewire lumen may extend the entire length of the catheter shaft 304 such as in an over-the-wire catheter or may extend only along a distal portion of the catheter shaft 304 such as in a single operator exchange (SOE) catheter. These examples are not intended to be limiting, but rather examples of some possible configurations. While not explicitly shown, the modulation system 300 may further include temperature sensor/wire, an infusion lumen, radiopaque marker bands, fixed guidewire tip, a guidewire lumen, external sheath, and/or other components to facilitate the use and advancement of the system 300 within the vasculature.
The system 300 may further include an elongated shaft 302 having a proximal end region 312 and a distal end region 314. In one embodiment, the elongated shaft 302 may be disposed within the lumen 308 of the catheter shaft 304. For example, in some instances, the elongated shaft 302 and the catheter shaft 304 may be advanced through the vasculature together and the catheter shaft 304 retracted proximally to expose the elongated shaft 302 once the system 300 has been placed adjacent the desired treatment region. Alternatively, the elongated shaft 302 may be distally advanced out from the distal end of the catheter shaft 304. In other embodiments, the catheter shaft 304 may function as a guide catheter and may be advanced to the desired treatment region before the elongated shaft 302. In some embodiments, the elongated shaft 302 may have a tubular configuration. However, other suitable configuration such as rectangular, oval, irregular, or the like may also be contemplated. For example, the elongated shaft 302 may be a thin bar, wire, or other structure. The material employed to manufacture the elongated shaft 302 may include a suitable biocompatible material such as, but not limited to, polymers, metals, alloys, or other suitable flexible materials known to those skilled in the art. In some embodiments, the material employed to manufacture the elongated shaft 302 may a piezoelectric material such as lead zirconate titanate (PZT) may be contemplated. In addition, other ceramic or piezoelectric materials known to those skilled in the art, such as barium titanate may also be used.
The modulation system 300 may further include one or more ablation transducers 316 disposed adjacent the distal end region 314 of the elongated shaft 302. The ablation transducers 316 may be formed from any suitable material such as, but not limited to, lead zirconate titanate (PZT). It is contemplated that other ceramic or piezoelectric materials may also be used. It is contemplated that the transducers 316 may have similar form and function to the transducers 208 discussed above. In some embodiments, there may be any number of ablation transducers 316 (one, two, three, four, or more) spaced about the circumference of the elongated shaft 302. This may allow for ablation of multiple radial locations about the body lumen simultaneously. In other embodiments, the ablation transducers 316 may comprise a focused or phased array of transducers. The array may be configured to be directed at a focus region such that multiple transducers are radiating energy at a common target region. It is further contemplated that the ablation transducers 316 may comprise a plurality of longitudinally spaced transducers.
The ablation transducers 316 may be connected to a control unit (such as control unit 18 in
The elongated shaft 302 may also be connected to a control unit and/or driver 310. The driver 310 may be adapted to provide and/or monitor the system 300 with one or more parameters such as, but not limited to, frequency for performing the desired ablation procedure. In some embodiments, the driver 310 may include an oscillator, which may provide mechanical movement to the elongated shaft or may propagate ultrasonic waves down the length of the elongated shaft 302. Exemplary oscillators may include a mechanical oscillator, acoustic oscillator, or other suitable oscillators known to those skilled in the art. In addition, those skilled in the art will appreciate that any other suitable drivers and/or energy sources may also be contemplated. While not explicitly shown, the driver 310 may be coupled to the elongated shaft 302 via an electrical connection or a mechanical connection. In certain instances, the connecting element may include an electrical conductor (not explicitly shown), adapted to supply power to the ablation transducers 316. This power may thus facilitate ablation of surrounding tissue within a vasculature.
In some embodiments, such as when a piezoelectric material is used for the elongated shaft 302, electricity may be provided to the elongated shaft 302, which may then be converted into vibrational energy as discussed above. The driver 310 may be configured to supply energy at a low frequency and at a higher amplitude relative to the frequency and amplitudes used for ablation to cause movement of the elongated shaft 302. The vibrational energy may cause the elongated shaft 302 to move back and forth in a direction 318 generally orthogonal to a longitudinal axis of the system 300. However, the elongated shaft 302 may vibrate in any other suitable directions known to those skilled in the art. The movement of the elongated shaft 302 may move the ablation transducers 316 back and forth within blood flow in the vessel, which may increase heat transfer from the transducers 316 to the blood, and thus cooling the ablation transducers 316. The movement of the elongated shaft 302 may also increase mixing of the blood, as well as reducing build-up of clots and/or other proteins.
The system 300 may be configured to operate at a first frequency for causing physical movement of the elongated shaft 302 and a second frequency for performing tissue modulation. Here, the first frequency may include a low frequency that may provide physical movement to the elongated shaft 302, thus providing cooling to the ablation transducers 316, as discussed above. It is contemplated that the first frequency may range from about 10 KHz to 200 KHz. It is further contemplated that the first frequency may include various other frequency ranges, as desired, based upon the physical affects produced. The second frequency may include a high frequency, which may ablate the target tissue. The second frequency may range from about 9-10 megahertz (MHz). It is contemplated that any desired frequency may be used, for example, from 1-20 MHz beyond. In general, the second frequency may be higher than the first frequency. The reverse configuration may also be utilized.
In other embodiments, such as when a piezoelectric material is not used for the elongated shaft 302, mechanical vibrations may be supplied over the length of the elongated shaft 302. For example, in some instances, the driver 310 may supply a mechanical or ultrasonic energy to the proximal end 312 of the elongated shaft 302. The mechanical or ultrasonic energy may cause the elongated shaft 302 to flex and/or vibrate along the entire length thereof. The vibrational energy may cause the elongated shaft 302 to move back and forth in a direction 318 generally orthogonal to a longitudinal axis of the system 300. However, the elongated shaft 302 may vibrate in any other suitable directions known to those skilled in the art. The movement of the elongated shaft 302 may move the ablation transducers 316 back and forth within blood flow in the vessel, which may increase heat transfer from the transducers 316 to the blood, and thus cooling the ablation transducers 316. The movement of the elongated shaft 302 may also increase mixing of the blood, as well as reducing build-up of clots and/or other proteins (e.g., along transducers 316).
The modulation system 300 may be advanced through the vasculature in any manner known in the art. For example, system 300 may include a guidewire lumen to allow the system 300 to be advanced over a previously located guidewire. In some embodiments, the modulation system 300 may be advanced, or partially advanced, within a guide sheath such as the catheter shaft 304. Once the ablation transducers 316 of the modulation system 300 have been placed adjacent to the desired treatment area, positioning mechanisms may be deployed, such as centering baskets, if so provided. While not explicitly shown, the ablation transducers 316 may be connected to a single control unit (such as control unit 18 in
Once the modulation system 300 has been advanced to the treatment region, energy may be supplied to the ablation transducers 316. In some instances, energy may first be supplied to the ablation transducers 316. As the energy is radiated from the ablation transducers 316, the ablation transducers 316 may begin to heat. The modulation system 300 may use temperature sensors, or the monitoring means, to monitor the temperature or efficiency of the ablation transducers 316. Once the ablation transducers 316 have reached a predetermined criterion, vibrational energy may then be supplied to the elongated shaft 302 resulting in physical movement of the elongated shaft 302. As discussed above, the energy supplied to the elongated shaft may be electrical or mechanical. As the elongated shaft 302 moves, increased convection may transfer heat away from the ablation transducers 316. It is contemplated that energy may be supplied to the ablation transducers 316 and the elongated shaft 302 in an alternating fashion such that one is activated while the other is inactive. In other embodiments, the ablation transducers 316 and the elongated shaft 302 may be activated simultaneously. The amount of energy delivered to the ablation transducers 316 may be determined by the desired treatment as well as the feedback provided by the system 300.
In some instances, the elongate shaft 302 may be rotated and additional ablation can be performed at multiple locations around the circumference of the vessel. In some instances, a slow automated “rotisserie” rotation can be used to work around the circumference of the vessel, or a faster spinning can be used to simultaneously ablate around the entire circumference. The spinning can be accomplished with a micro-motor or by spinning a drive shaft. In some embodiments, ultrasound sensor information can be used to selectively turn on and off the ablation transducers 316 to warm any cool spots or accommodate for veins, or other tissue variations. The number of times the elongated shaft 302 is rotated at a given longitudinal location may be determined by the number and size of the ablation transducers 316 on the elongated shaft 302. Once a particular location has been ablated, it may be desirable to perform further ablation procedures at different longitudinal locations. Once the elongated shaft 302 has been longitudinally repositioned, energy may once again be delivered to the ablation transducers 316 and the elongated shaft 302. If necessary, the elongated shaft 302 may be rotated to perform ablation around the circumference of the vessel at each longitudinal location. This process may be repeated at any number of longitudinal locations desired. It is contemplated that in some embodiments, the system 300 may include ablation transducers at various positions along the length of the modulation system 300 such that a larger region may be treated without longitudinal displacement of the elongated shaft 302.
The modulation system may further include a bar element 408 extending distally from the distal end region 406 of the catheter shaft 402. In some embodiments, the bar element 408 may include a long, thin bar-shaped element. It may be contemplated that other suitable shapes such as, but limited to rectangular, square, cylindrical, oval, irregular, and so forth may be used, as desired. The bar element 408 may have a proximal end (not explicitly shown) bonded, clamped or otherwise secured to the distal end region 406 of the catheter shaft 402. The bar element 408 may be formed of a piezoelectric material, such as, but not limited to, lead zirconate titanate (PZT) or barium titanate. It is contemplated that other ceramic or piezoelectric materials known to those skilled in the art may also be used. In some embodiments, the bar element 408 may include any suitable flexible biocompatible material such as, but are not limited to, polymers, metals, alloys, either in combination or alone.
The modulation system 400 may further include a tension member 412, such a tension ribbon or tension wire, disposed adjacent to the bar element 408. The tension member 412 may include a distal end 414 and a proximal end (not explicitly shown). In some instances, the proximal end of the tension member 412 may extend proximally to a location exterior to the patient's body. The distal end 414 of the tension member 412 may be bonded, clamped, or otherwise secured to the distal end 410 of the bar element.
The system 400 may include one or more ablation transducers 416 mounted on the distal end region bar element 408. The ablation transducers 416 may be formed from any suitable material such as, but not limited to, lead zirconate titanate (PZT). It is contemplated that other ceramic or piezoelectric materials may also be used. The transducers 416 may have similar form and function to the transducers 208 discussed above. In some embodiments, there may be any number of ablation transducers 416 (one, two, three, four, or more) spaced about the circumference of the bar element 408. This may allow for ablation of multiple radial locations about the body lumen simultaneously. In other embodiments, the ablation transducers 416 may comprise a focused or phased array of transducers. The array may be configured to be directed at a focus region such that multiple transducers are radiating energy at a common target region. It is further contemplated that the ablation transducers 416 may comprise a plurality of longitudinally spaced transducers.
The ablation transducers 416 may be connected to a control unit 418 by an electrical conductor(s). In some embodiments, the electrical conductor(s) may be disposed within a lumen of the catheter shaft 402. In other embodiments, the electrical conductor(s) may extend along an outside surface of the catheter shaft 402. The electrical conductor(s) may provide electricity to the ablation transducers 416, which may then be converted into acoustic energy. The acoustic energy may be directed from the ablation transducers 416 in a direction generally perpendicular to the radiating surfaces of the transducers 416. As discussed above, acoustic energy radiates from the ablation transducers 416 in a pattern related to the shape of the transducers 416 and lesions formed during ablation take shape similar to contours of the pressure distribution.
The bar element 408 may also be connected to a control unit 418 by electrical and/or mechanical means 424. In some embodiments, the connection 424 may be disposed within a lumen of the catheter shaft 402. In other embodiments, the connection 424 may extend along an outside surface of the catheter shaft 402. In some instances, the connection 424 may provide electricity to the bar element 408 which may then be converted into vibrational energy. In other embodiments, the control unit 418 may include an oscillator, which may provide mechanical movement, ultrasonic or other vibration, which may be transmitted along the length of the connection 424 to the bar element 408. Exemplary oscillators may include a mechanical oscillator, acoustic oscillator, or other suitable oscillators known to those skilled in the art. In addition, those skilled in the art will appreciate that any other suitable drivers and/or energy sources may also be contemplated. In certain instances, the control unit 418 may include an electrical conductor (not explicitly shown), adapted to supply power to the ablation transducers 416. This power may thus facilitate ablation of surrounding tissue within a vasculature.
In some cases, a driver creates vibration energy, which vibrates the bar element 408 through connection 424 and tension member 412. The vibrational energy may cause the bar element 408 to move back and forth in a direction 422 generally parallel to a longitudinal axis of the system 400. However, the bar element 408 may vibrate in any other suitable directions known to those skilled in the art. Longitudinal vibration of the distal end 410 of the bar element 408 in direction 422 combined with fixation of the proximal end of the bar element 408 at the distal end region 406 of catheter shaft 402 may cause the bar element 408 to flex and/or buckle and vibrate in a direction 426 generally orthogonal to a longitudinal axis of the system 400. This may cause the bar element 408 to flex and/or buckle in a direction 426 generally orthogonal to a longitudinal axis of the system 400. For example, a central region of the bar element 408 may bend back and forth to form concave and convex configurations. The movement of the bar element 408 may move the ablation transducers 416 back and forth within blood flow in the vessel which may increase heat transfer from the transducers 416 to the blood, and thus cooling the ablation transducers 416. The movement of the bar element 408 may also increase mixing of the blood, as well as reducing build-up of clots and/or other proteins (e.g., along transducers 416).
In some embodiments, the bar element 410 may be caused to flex and/or buckle in a direction 426 generally orthogonal to a longitudinal axis of the system 400 through actuation of the tension member 412. As discussed above, the tension member 412 may extend proximally through the lumen 404 of the catheter shaft to a location exterior to a patient's body. This may allow a user to manually actuate the tension member 412 in a piston-like push-pull manner to cause the bar element 410 to flex. As the tension member 412 is pulled proximally, the distal end 414 of the tension member 412 which is attached to the distal end of the bar element 410 may be moved proximally. This may cause the distal end of the bar element to move proximally as well. As the proximal end of the bar element 410 is fixedly secured, the bar element 410 is not longitudinally displaced with the tension member 412. As such, a central region of the bar element 408 may bend to form concave and/or convex configuration. As the tension member 412 is advanced distally, the bar element 408 may relax and return to a generally straight configuration. The movement of the bar element 408 may move the ablation transducers 416 back and forth within blood flow in the vessel which may increase heat transfer from the transducers 416 to the blood, and thus cooling the ablation transducers 416. The movement of the bar element 408 may also increase mixing of the blood, as well as reducing build-up of clots and/or other proteins (e.g., along transducers 416). It is further contemplated that the proximal end of the tension member 412 may be attached to a driver, such as driver 418, to automatically drive the push-pull actuation of the tension member 412.
The system 400 may be configured to operate at a first frequency for causing physical movement of the bar element 408 and a second frequency for performing tissue modulation. Here, the first frequency may include a low frequency that may provide physical movement to the bar element 408, thus providing cooling to the ablation transducers 416, as discussed above. It is contemplated that the first frequency may range from about 10 KHz to 200 KHz. It is further contemplated that the first frequency may include various other frequency ranges, as desired, based upon the physical affects produced. The second frequency may include a high frequency, which may ablate the target tissue. The second frequency may range from about 9-10 megahertz (MHz). It is contemplated that any desired frequency may be used, for example, from 1-20 MHz beyond. In general, the second frequency may be higher than the first frequency. The reverse configuration may also be utilized.
In other embodiments, such as when a piezoelectric material is not used for the bar element 408, mechanical vibrations may be supplied to the bar element 408. For example, in some instances, the control unit 418 may supply a mechanical or ultrasonic energy to the bar element 408. The mechanical or ultrasonic energy may cause the bar element 408 to flex and/or vibrate along the entire length thereof. The vibrational energy may cause the bar element 408 to move back and forth in a direction 422 generally parallel to a longitudinal axis of the system 400. However, the bar element 408 may vibrate in any other suitable directions known to those skilled in the art. As the bar element 408 is longitudinally secured at both its proximal end and distal end 410, longitudinal vibration of the bar element 408 is prevented. This may cause the bar element 408 to flex and/or buckle in a direction 426 generally orthogonal to a longitudinal axis of the system 400. For example, a central region of the bar element 408 may bend back and forth to form concave and convex configurations. The movement of the bar element 408 may move the ablation transducers 416 back and forth within blood flow in the vessel which may increase heat transfer from the transducers 416 to the blood, and thus cooling the ablation transducers 416. The movement of the bar element 408 may also increase mixing of the blood, as well as reducing build-up of clots and/or other proteins.
The modulation system 400 may be advanced through the vasculature in any manner known in the art. For example, system 400 may include a guidewire lumen to allow the system 400 to be advanced over a previously located guidewire. In some embodiments, the modulation system 400 may be advanced, or partially advanced, within a guide sheath, such as the sheath 16 shown in
Once the modulation system 400 has been advanced to the treatment region, energy may be supplied to the ablation transducers 416. In some instances, energy may first be supplied to the ablation transducers 416. As the energy is radiated from the ablation transducers 416, the ablation transducers 416 may begin to heat. The modulation system 400 may use temperature sensors, or the monitoring means, to monitor the temperature or efficiency of the ablation transducers 416. Once the ablation transducers 416 have reached a predetermined criteria, energy may then be supplied to the bar element 408 resulting in physical movement of the bar element 408. As discussed above, the energy supplied to the elongated shaft may be electrical or mechanical. As the bar element 408 moves, increased convection may transfer heat away from the ablation transducers 416. It is contemplated that energy may be supplied to the ablation transducers 416 and the bar element 408 in an alternating fashion such that one is activated while the other is inactive. In other embodiments, the ablation transducers 416 and the bar element 408 may be activated simultaneously. The amount of energy delivered to the ablation transducers 416 may be determined by the desired treatment as well as the feedback provided by the system 400.
In some instances, the catheter shaft 402 may be rotated and additional ablation can be performed at multiple locations around the circumference of the vessel. In some instances, a slow automated “rotisserie” rotation can be used to work around the circumference of the vessel, or a faster spinning can be used to simultaneously ablate around the entire circumference. The spinning can be accomplished with a micro-motor or by spinning a drive shaft. In some embodiments, ultrasound sensor information can be used to selectively turn on and off the ablation transducers 416 to warm any cool spots or accommodate for veins, or other tissue variations. The number of times the catheter shaft 402 is rotated at a given longitudinal location may be determined by the number and size of the ablation transducers 416 on the bar element 408. Once a particular location has been ablated, it may be desirable to perform further ablation procedures at different longitudinal locations. Once the catheter shaft 402 has been longitudinally repositioned, energy may once again be delivered to the ablation transducers 416 and the bar element 408. If necessary, the catheter shaft 402 may be rotated to perform ablation around the circumference of the vessel at each longitudinal location. This process may be repeated at any number of longitudinal locations desired. It is contemplated that in some embodiments, the system 400 may include ablation transducers at various positions along the length of the modulation system 400 such that a larger region may be treated without longitudinal displacement of the catheter shaft 402.
Those skilled in the art will recognize that the present invention may be manifested in a variety of forms other than the specific embodiments described and contemplated herein. Accordingly, departure in form and detail may be made without departing from the scope and spirit of the present disclosure as described in the appended claims.
This application claims priority under 35 U.S.C. § 119 to U.S. Provisional Ser. No. 61/704,205, filed Sep. 21, 2012, the entirety of which is incorporated herein by reference.
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| Number | Date | Country | |
|---|---|---|---|
| 20140088630 A1 | Mar 2014 | US |
| Number | Date | Country | |
|---|---|---|---|
| 61704205 | Sep 2012 | US |
