ABLATION PROBE AND LUMEN FOR IMPROVED ACCESS AND FLOW
20240065751 ยท 2024-02-29
Assignee
Inventors
- Jeffrey Haczynski (Naples, FL, US)
- Richard J. Taft (Naples, FL, US)
- Stephen Donnigan (Castle Rock, CO, US)
- Jeremiah D. Caldwell (Napel, FL, US)
Cpc classification
A61B18/148
HUMAN NECESSITIES
A61B2018/142
HUMAN NECESSITIES
International classification
Abstract
An apparatus and method provide for the delivery of an ablation treatment by supplying a control signal to supply electrode of an ablation device disposed at the distal end portion of an elongated shaft. A lumen extends along a longitudinal axis of the shaft. The supply electrode forms an electrode face laterally directed from the longitudinal axis and through which an aperture extends in connection with the lumen. The electrode face forms an ovular shape having a first major axis that extends parallel to the longitudinal axis. An insulator separates the supply electrode from a return electrode, and a transition passage of the lumen extends though the insulator along an arc-shaped path.
Claims
1. An ablation apparatus comprising: an elongated shaft comprising a lumen extending along a longitudinal axis from a proximal end portion to a distal end portion; a supply electrode forming an electrode face directed laterally from the longitudinal axis at the distal end portion, the electrode face comprising at least one aperture in connection with the lumen; a return electrode extending along the distal end portion of the elongated shaft; and an insulator interposed between the supply electrode and the return electrode, the insulator forming a transition passage of the lumen interconnecting the at least one aperture to the lumen along an arcuate swept path.
2. The apparatus according to claim 1, wherein the elongated shaft extends to a distal extent of the ablation apparatus and the return electrode extends over a portion of the distal extent.
3. The apparatus according to claim 1, wherein the transition passage forms an inlet cross section that decreases along the transition passage to an outlet cross section in connection with the lumen.
4. The apparatus according to claim 1, wherein a cross section of the internal passage forming the transition passage is swept from the longitudinal axis along the lumen to the at least one aperture extending laterally from the longitudinal axis.
5. The apparatus according to claim 1, wherein the electrode face of the supply electrode forms a distal electrode portion that tapers outward from the longitudinal axis of the apparatus to a proximal end portion.
6. The apparatus according to claim 5, wherein the elongated shaft forms a tapered end portion opposing the electrode face.
7. The apparatus according to claim 6, wherein the elongated shaft tapers gradually along the longitudinal axis to a distal extent of the ablation apparatus on a first side opposing the electrode face as well as a second side and a third side extending along opposing sides of the electrode face.
8. The apparatus according to claim 7, wherein the tapered end portion tapers along a slope that increases with increasing proximity to the distal extent.
9. The apparatus according to claim 1, wherein the supply electrode forms a perimeter edge adjacent to the insulator and extends from a proximal electrode portion to a distal electrode portion, wherein the perimeter edge is evenly spaced from the return electrode along the distal end portion.
10. The apparatus according to claim 1, wherein the supply electrode extends approximately equidistant from the return electrode along at least a distal 25% of an electrode length L.sub.e of the supply electrode.
11. The apparatus according to claim 10, wherein the approximately equidistant spacing between the supply electrode and the return electrode includes an average spacing that is evenly spaced on average over the distal end portion including variations in a perimeter edge of the supply electrode and a return edge of the return electrode.
12. The apparatus according to claim 1, wherein the electrode face forms an ovular shape comprising a proximal electrode portion and a distal electrode portion, and a major axis of the ovular shape extends parallel to the longitudinal axis.
13. The apparatus according to claim 12, wherein the proximal electrode portion forms a first arc comprising a first radius and the distal electrode portion forms a second arc comprising a second radius, wherein the first radius is greater than the second radius.
14. A method for delivering an ablation treatment comprising: supplying a control signal to supply electrode of an ablation device; conducting the control signal through the supply electrode to a return electrode across an insulating gap, wherein the insulating gap is approximately constant over a distal end portion of the supply electrode and conducting the control signal across an insulating gap generates an edge ablation region extending about the distal end portion of the ablation device between the supply electrode and the return electrode; and communicating fluid through a lumen extending through an elongated shaft of the ablation device.
15. The method according to claim 14, wherein the communicating fluid through a lumen of the ablation device comprises: communicating the fluid through at least one aspiration port extending laterally from the lumen and through the supply electrode
16. The method according to claim 15, wherein the communicating fluid through a lumen of the ablation device further comprises: steering the fluid along an arcuate path from the at least one aspiration port to the lumen.
17. The method according to claim 16, wherein the communicating of the fluid further comprises communicating the fluid through a decreasing cross-sectional area along the arcuate path from the supply electrode to the lumen.
18. The method according to claim 14, further comprising: passing an acting end of the ablation device through a rigid cylindrical access envelope having a diameter and a length, wherein the diameter is less than two times a width of the elongated shaft and the length is at least two times the width.
19. An ablation apparatus comprising: an elongated shaft comprising a lumen extending along a longitudinal axis from a proximal end portion to a distal end portion; a supply electrode forming an electrode face directed laterally from the longitudinal axis at the distal end portion and comprising at least one aperture in connection with the lumen, the electrode face having an ovular shape comprising: a first major axis parallel to the longitudinal axis; a proximal electrode portion forming a first arc comprising a first radius; and a distal electrode portion forming a second arc comprising a second radius, wherein the first radius is greater than the second radius; a return electrode extending along the distal end portion of the elongated shaft; and an insulator interposed between the supply electrode and the return electrode, the insulator forming a transition passage of the lumen interconnecting the at least one aperture to the lumen.
20. The apparatus according to claim 19, wherein the distal end portion of the ablation apparatus forms a torpedo shape that tapers to a distal extent of the ablation apparatus along opposing edges of electrode face and along a rear surface opposite the electrode face.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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[0008]
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[0010]
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DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0019] Ablation devices and corresponding systems may provide beneficial utility for minimally invasive medical procedures. Such procedures may limit patient recovery times and improve outcomes by applying specialized surgical techniques and tools to remotely access various treatment areas. As discussed in the following description, the disclosure provides for an ablation device or apparatus configured to effectively deliver ablation treatment to highly constrained anatomical areas. In some examples, the ablation device may provide for an interior lumen configured to provide improved fluid transmission to limit clogging while simultaneously limiting the proportions of an access envelope necessary for the ablation device to reach a cavity or treated area of a patient. In an exemplary embodiment, a tapered or torpedo-shaped distal profile of the ablation device may be implemented with a complimentary electrode configuration and fluid transmission lumen to provide a combination of improved delivery of surgical energy and access while limiting issues with clogging and fluid transmission. Though discussed in relation to specific exemplary devices, each of the corresponding features may be implemented alone or in various combinations to enhance and improve the operation of an ablation device. Accordingly, the disclosure may provide for an improved ablation device or probe suited to a variety of applications.
[0020] Referring now to
[0021] The ablation device 10 may extend from a handle or user interface portion, referred to herein as a proximal end portion 30a, to a distal end portion 30b. The distal end portion 30b may correspond to an acting end where the supply electrode 12 is disposed and configured to supply therapeutic energy to a target region of a patient. To ensure that the ablation device 10 is capable of reaching a target area, particularly within the tight confines of a rigid joint space, the distal end portion 30b may comprise a torpedo-like or tapered end portion 32. The tapered end portion 32 may gradually narrow circumferentially about the electrode face 24, which may be substantially flat or planar. The tapering of the distal end portion 30b may narrow distally along a longitudinal axis A.sub.L circumferentially about the electrode face 24 in a parabolic dome along at least a portion of a length of the supply electrode 12. The distal end portion 30b of the ablation device 10 may terminate at a distal extent 34. In general, the tapered end portion 32 of the ablation device 10 may provide for the distal end portion 30b to access various cavities or openings within the anatomy of a patient without encountering challenges or encumbrances due to protrusions extending outward or bending away from the longitudinal axis A.sub.L.
[0022] As discussed further in various examples that follow, the tapered end portion 32 of the ablation device 10 may be implemented in combination with the ovular profile shape 40 of the supply electrode 12. In such implementations, the profile shape 40 may narrow in parallel with the tapered end portion 32 of the insulator 16 to improve the distal access of the device 10. In general, the supply electrode 12 may be configured to effectively deliver radio frequency (RF) energy between the supply electrode 12 and the return electrode 14, even over the distal extent 34 of the device 10. As further discussed in reference to
[0023] The tapered end portion 32 and corresponding features of the ablation device 10 may provide for the electrode face 24 to be substantially planar, having a projecting surface directed laterally from the longitudinal axis A.sub.L while limiting protrusions or spatial divergences away from the longitudinal axis A.sub.L. In this way, an elongated body of the ablation device 10 may enter a long and narrow access envelope (AE), such that the ablation device 10 may be implemented in a variety of endoscopic or arthroscopic procedures. An exemplary representation of the access envelope AE is shown in
[0024] Referring still to
[0025] As best depicted in
[0026] Referring now to
[0027] As discussed herein, the term approximate may correspond to and include minor variations in dimensions that may be associated with equivalent structures as well as variations in various manufacturing processes. For example, as discussed herein, the spacing being approximately equidistant or constant may correspond to and include variations in spacing (S.sub.xy, S.sub.z) ranging from approximately 5% to 10% between the supply electrode 12 and the return electrode 14. Similarly, approximately constant spacing may correspond to spacing that is nearly constant about the perimeter edge 52 of the supply electrode 12 on average, which may incorporate various dimensional variations about the perimeter edge 52 while still maintaining an equivalent average dimensional spacing therebetween. In general, the term approximate may be used in this application to describe various relationships and/or dimensions and may be interpreted to include corresponding variations that may provide for similar or equivalent structures. Accordingly, dimensional or relational variations of 5% to 10% may be associated with the use of approximate terminology herein. The extent of the variation or range associated with the terms approximate or substantially may be understood by those skilled in the art based on the nature of the shapes, dimensions, relationships and the corresponding structures, features, and applications to which they correspond, such that the metes and bounds are limited to structures that maintain the operational functionality associated with the particular technological solution associated.
[0028] Though discussed in reference to the specific illustrated embodiment shown in
[0029] Referring now to
[0030] The at least one aspiration port 22 may correspond to a plurality of aspiration ports 22 (e.g., three aspiration ports), which may be evenly spaced over the electrode face 24 within a perimeter formed by the first group of raised ridges 62a and the second group of raised ridges 62b or, more generally, the protrusions 62. As further discussed in reference to
[0031] As demonstrated in
[0032] Referring now to
[0033] Referring now to
[0034] Though no numeric scale is shown in relation to the flow simulation in
[0035] Referring now to
[0036] Each of the dimensions associated with the ablation device 10 may be proportioned based on the dimensional requirements for a surgical application. However, the relative proportions, particularly between the depth Z, the width W, and the limited divergence from the longitudinal axis A.sub.L, are provided by the relationship among the features forming the acting end 54, including the supply electrode 12, the return electrode 14, the insulator 16, as well as the transition passage 44 in connection with the lumen 20. In some implementations, the depth Z of the ablation device 10 may be less than 50% larger than the width W. In some examples, the depth Z may be less than 40%, 30%, and even less than 20% larger than the width W as defined by the outer wall 18a of the shaft 18. As depicted in
[0037] Referring now to
[0038] In some implementations, the intensity of the ablation field 82 may be uniformly distributed about the perimeter edge 52 as a result of the geometry of the acting end 54, including the spacing between the supply electrode 12 and the return electrode 14. For example, as previously discussed, the consistent or approximately equidistant spacing along or parallel to the electrode face 24, denoted as S.sub.xy, and the spacing perpendicular to the electrode face 24, denoted as S.sub.z, may provide for distributed transmission of the current that drives or induces the ablation field 82 along the edge ablation region 84. As shown in
[0039] In some examples, the edge ablation region 84 may be positioned proximate to tissue such that ablation therapy may be applied along the perimeter 52 of the electrode face 24 along the first arc 40a and the opposing or straight side portions 40c without effectuating ablation treatment to tissue over the electrode face 24. Accordingly, ablation energy may be selectively applied along the perimeter 52 by the edge ablation region 84. Additionally, ablation energy may be selectively applied over the electrode face 24. The determination of whether the ablation energy is delivered along the electrode face 24, the perimeter edge 52, or both regions may be controlled by maneuvering the acting end 54 to adjust the proximity of the opposing sides 46 or the electrode face 24 proximate to the target or treatment region. For example, if the opposing sides 46 are arranged closer to tissue than the electrode face 24, the ablation energy may act on the tissue along the edge ablation region 84. Alternatively, if the opposing sides 46 are arranged further from the tissue than the electrode face 24, the ablation energy may act on the tissue along the electrode face 24. If both the electrode face 24 and the opposing sides 46 are similarly spaced from the target tissue, the ablation treatment may be applied to the tissue along the electrode face 24 and the side portions 46.
[0040] The edge ablation region 84 may additionally provide for the distal electrode portion 24b of the acting end 54 to extend into narrow cavities (e.g., joint spaces) that may not accommodate the comparatively enlarged proportions of the proximal electrode portion 24a. That is, the gradual narrowing of the torpedo-like, tapered end portion 32 may provide for the distal electrode portion 24b and the edge ablation region 84 to access spaces and apply ablation treatments therein. Additionally, the uniform spacing between the supply electrode 12 and the return electrode 14 about the perimeter 52 may ensure the edge ablation region 84 is evenly distributed in intensity. In this configuration, the effect of the edge ablation region 84 about the perimeter 52 of the electrode face 24 may be applied with consistent results and spacing from the target tissues as when applying ablation treatment with the ablation field extending over the electrode face 24. Such consistency may provide for reliable and consistent treatment results that improve the user experience and patient outcomes.
[0041] Referring now to
[0042] The conductive connectors 106 may be connected to the active or supply electrode 12 to transmit the output control signal Tx and connected to the return electrode 14 to receive a return signal Rx. The return signal Rx may be monitored by the controller 92 to provide closed-loop feedback to adjust the control signal Tx. The control signal Tx from the signal generator 104 may correspond to an AC driving signal generated in response to time-modulated signals from a processor 110 of the controller 92. The AC driving signal may induce the treatment or ablation field in the form of RF energy. The modes of operation of the ablation device 10 may be controlled by adjusting the amplitude of the voltage and timing of the signal modulation that instructs the signal generator 104 to generate RF signals. Accordingly, by adjusting the voltage potential and the frequency or timing characteristics of the AC driving signal output from the signal generator 104, the controller 92 may control the operation of the ablation device 10 in response to inputs received via the user interface 88. In some embodiments, the controller 92 may be configured to activate one or more preset modes (e.g., ablation, coagulation) and the associated power levels or frequencies as presets in response to inputs received from the user interface 88.
[0043] The processor 110 of the controller 92 may be implemented as a microprocessor, microcontroller, application-specific integrated circuit (ASIC), or other circuitry configured to perform instructions, computations, and control various input/output signals to control the ablation system 90. The instructions and/or control routines 112 of the system 90 may be accessed by the processor 110 via a memory 114. The memory 114 may comprise random access memory (RAM), read only memory (ROM), flash memory, hard disk storage, solid state drive memory, etc. The controller 92 may incorporate additional communication circuits or input/output circuitry. In an exemplary embodiment, a communication interface 116 of the controller 92, may include digital-to-analog converters, analog-to-digital converters, digital inputs and outputs, as well as one or more peripheral communication interfaces or busses. The peripheral communication interfaces of the communication interface 116 may be implemented with by various communication protocols, such as serial communication (e.g., CAN bus, I2C, etc.), parallel communication, network communication (e.g., RS232, RS485, Ethernet), wireless network communication (Wi-Fi, 802.11, etc.). In some examples, the controller 92 may be in communication with one or more external devices 118 (e.g., control devices, peripherals, servers, etc.) via the communication interface 116. Accordingly, the control unit 94 may provide for communication with various devices to update, maintain, and control the operation of the ablation system 90.
[0044] Though not pictorially illustrated in the figures, a pump 120 or aspiration pump may be connected via one or more fluid conduits in connection with the lumen 20 to effectuate fluid transfer via a fluid transmission path FP comprising the aspiration aperture(s) or port(s) 22, the transition passage 44, and the lumen 20. The pump 120 may be controlled via the user interface 88 of the controller 92 to adjust a flow rate or intensity of the fluid transfer. The pump 120 may be implemented with a variety of pumping technologies (e.g., peristaltic, reciprocating, etc.) and may vary in fluid transfer capacity based on the application of the ablation device 10.
[0045] According to some aspects of the disclosure, an ablation apparatus comprises an elongated shaft comprising a lumen extending along a longitudinal axis from a proximal end portion to a distal end portion, a supply electrode forming an electrode face directed laterally from the longitudinal axis at the distal end portion and forming an electrode face comprising at least one aperture in connection with the lumen, a return electrode extending along the distal end portion of the elongated shaft; and an insulator interposed between the supply electrode and the return electrode, the insulator forming a transition passage of the lumen interconnecting the at least one aperture to the lumen along an arcuate swept path.
[0046] According to various aspects, the disclosure may implement one or more of the following features or configurations in various combinations: [0047] the elongated shaft extends to a distal extent of the ablation apparatus and the return electrode extends over a portion of the distal extent; [0048] the transition passage forms an inlet flow cross section that decreases along the transition passage to outlet cross section in connection with the lumen; [0049] a cross section of the internal passage forming the transition passage is swept from the longitudinal axis along the lumen to the at least one aperture extending laterally from the longitudinal axis; [0050] the electrode face of the supply electrode forms a distal electrode portion that tapers outward from the longitudinal axis of the apparatus to a proximal end portion; [0051] the elongated shaft forms a tapered end portion opposing the electrode face; [0052] the elongated shaft tapers gradually along the longitudinal axis to a distal extent of the ablation apparatus on a first side opposing the electrode face and as well as a second side and a third side extending along opposing sides of the electrode face; [0053] the tapered end portion taper at along a slope that increases with increasing proximity to the distal extent; [0054] the supply electrode forms a perimeter edge adjacent to the insulator and extends from a proximal electrode portion to a distal electrode portion; [0055] the perimeter edge is evenly spaced from the return electrode along the distal end portion; [0056] the supply electrode extends approximately equidistant from the return electrode along at least a distal 25% of an electrode length Le of the supply electrode; [0057] the approximately equidistant spacing between the supply electrode and the return electrode includes an average spacing that is evenly spaced on average over the distal end portion including variations in the perimeter edge of the supply electrode as well as a return edge of the return electrode; [0058] the electrode face forms an ovular shape comprising a proximal electrode portion and a distal electrode portion; [0059] a major axis of the ovular shape extends parallel to the longitudinal axis; and [0060] the proximal electrode portion forms a first arc comprising a first radius and the distal electrode portion forms a second arc comprising a second radius, the first radius is greater than the second radius.
[0061] According to another aspect, a method is disclosed for delivering an ablation treatment comprising supplying a control signal to supply electrode of an ablation device, conducting the control signal through the supply electrode to a return electrode across an insulating gap, the insulating gap is approximately constant over a distal end portion of the supply electrode, and communicating fluid through a lumen extending through an elongated shaft of the ablation device.
[0062] According to various aspects of the invention, the disclosure many implement one or more of the following features or configurations in various combinations: [0063] the communicating fluid through a lumen of the ablation device comprises communicating the fluid through at least one aspiration port extending laterally from the lumen and through the supply electrode; [0064] steering the fluid along an arcuate path from the at least one aspiration port to the lumen; [0065] the communicating of the fluid further comprises communicating the fluid through a decreasing cross-sectional area along the arcuate path from the supply electrode to the lumen; and/or [0066] passing an acting end of the ablation device through a rigid cylindrical access envelope having a diameter and a length, wherein the diameter is less than two times a width of the elongated shaft and the length is at least two times the width.
[0067] According to yet another aspect of the invention, an ablation apparatus comprises an elongated shaft comprising a lumen extending along a longitudinal axis from a proximal end portion to a distal end portion, a supply electrode forming an electrode face directed laterally from the longitudinal axis at the distal end portion, the electrode face comprising at least one aperture in connection with the lumen, wherein the electrode face forms an ovular shape having a first major axis that extends parallel to the longitudinal axis, a proximal electrode portion forming a first arc comprising a first radius, and a distal electrode portion forming a second arc comprising a second radius, wherein the first radius is greater than the second radius, a return electrode extending along the distal end portion of the elongated shaft, and an insulator interposed between the supply electrode and the return electrode, the insulator forming a transition passage of the lumen interconnecting the at least one aperture to the lumen.
[0068] According to various aspects, the disclosure may implement one or more of the following features or configuration in various combinations: [0069] the distal end portion of the ablation apparatus forms a torpedo shape that tapers to a distal extent of the ablation apparatus along opposing edges of electrode face and along a rear surface opposite the electrode face; [0070] the electrode face comprises a plurality of protrusions extending along the first arc and the second arc and about the at least one aperture; [0071] the protrusions protrude from the electrode face along a radius to a protrusion distance; [0072] the protrusions form elongated ridges that extend parallel to the ovular shape of the electrode face; [0073] at least one aperture comprises a plurality of apertures evenly distributed over an internal cross section of the transition passage in fluid communication the lumen; and [0074] the plurality of apertures form ovular apertures having a second major axis that extends perpendicular to the first major axis of the supply electrode. [0075] the transition passage forms an ovular opening that terminates at the supply electrode, the ovular opening comprises a major axis extending along the longitudinal axis; [0076] the plurality of apertures are formed through the supply electrode and spaced along the longitudinal axis; and [0077] the plurality of apertures form ovular apertures having a major axis that extends perpendicular to the longitudinal axis along the electrode face.
[0078] According to various aspects, the disclosure may provide an access envelope, particularly for applications passing through cannula but also percutaneously: [0079] the elongated shaft extends along the longitudinal axis and comprises a lateral wall forming the lumen; [0080] the lateral wall extends outward over a lateral distance of W/2 to a width W of the lateral wall; [0081] an acting end of the ablation apparatus comprises the active electrode, the insulator, and the return electrode, the extents of which define an access envelope or minimum access cross section of the ablation apparatus along the longitudinal axis; [0082] the acting end extends along the longitudinal axis and diverges from the longitudinal axis by less than 25% of the width of the elongated shaft; [0083] the access envelope is defined as a volumetric path formed by a cross-sectional area of the distal end portion of the ablation apparatus extending along the longitudinal axis; [0084] the access envelope fits within a cylindrical boundary having a diameter of less than 2(W), less than 1.8(W), less than 1.6(W), or even less than 1.5(W) down to approximately 1.4(W); [0085] the ablation apparatus comprises a depth (Z) extending from the electrode face to an opposing side portion formed by the elongated shaft, wherein, the cross-sectional area fits within a cylindrical boundary less than 1.5Z); [0086] the depth (Z) is less than 1.75 times the width W of the lateral wall and may be less than 1.5 times the width W, less than 1.2 times the width of the lateral wall down to approximately 1.18 times the width of the later wall; and/or [0087] the ablation apparatus fits within a volumetric access envelope extending along the longitudinal axis having a cross-sectional area of 1.5 times an outside shaft diameter of the elongated shaft over a length of at least three times the outside shaft diameter.
[0088] It will be understood that any described processes or steps within described processes may be combined with other disclosed processes or steps to form structures within the scope of the present device. The exemplary structures and processes disclosed herein are for illustrative purposes and are not to be construed as limiting.
[0089] It is also to be understood that variations and modifications can be made on the aforementioned structures and methods without departing from the concepts of the present device, and further it is to be understood that such concepts are intended to be covered by the following claims unless these claims by their language expressly state otherwise.
[0090] The above description is considered that of the illustrated embodiments only. Modifications of the device will occur to those skilled in the art and to those who make or use the device. Therefore, it is understood that the embodiments shown in the drawings and described above are merely for illustrative purposes and not intended to limit the scope of the device, which is defined by the following claims as interpreted according to the principles of patent law, including the Doctrine of Equivalents