The present disclosure is directed to the area of ablation systems and methods of making and using the systems. The present disclosure is also directed to systems and methods of treatment for sacroiliac (SI) joint pain by nerve ablation using short, high voltage pulses.
Ablation generators and electrodes can be used for pain relief or functional modification. Ablation can be used to treat cardiac arrhythmias, benign tumors, cancerous tumors, and to control bleeding during surgery. Ablation is a safe, proven means of interrupting pain signals, such as those coming from irritated facet joints in the spine, genicular nerves in the knee, and femoral and obturator nerves in the hip. There is a need for new ablation treatments to address pain and other disorders.
One aspect is a method to treat sacroiliac joint pain. The method includes inserting at least one ablation electrode into a patient to ablate at least one spinal nerve extending from the spinal cord in the vertebral range of the lumbar vertebrae L3, L4, or L5 or any of the sacral vertebrae; and applying pulses to the at least one ablation electrode to ablate the at least one nerve, wherein each of the pulses has a duration of no more than 500 microseconds and at least some of the pulses have a voltage of at least 1 kV.
Another aspect is a system for treating sacroiliac joint pain. The system includes a memory having instructions stored thereon and a processor configured to execute those instructions to perform actions including applying pulses to at least one ablation electrode to ablate at least one spinal nerve extending from the spinal cord in the vertebral range of the lumbar vertebrae L3, L4, or L5 or any of the sacral vertebrae, wherein each of the pulses has a duration of no more than 500 microseconds and at least some of the pulses have a voltage of at least 1 kV.
A further aspect is a non-transitory computer-readable medium having stored thereon instructions for treating sacroiliac joint pain, wherein the instructions, when executed by a processor, perform actions including applying pulses to at least one ablation electrode to ablate at least one spinal nerve extending from the spinal cord in the vertebral range of the lumbar vertebrae L3, L4, or L5 or any of the sacral vertebrae, wherein each of the pulses has a duration of no more than 500 microseconds and at least some of the pulses have a voltage of at least 1 kV.
In at least some aspects, the at least one spinal nerve includes at least one sacral lateral branch nerve. In at least some aspects, each of the pulses has a voltage of at least 2 kV. In at least some aspects, each of the pulses has a voltage of at least 3 kV. In at least some aspects, at least a plurality of the pulses each have a duration of no more than 100 microseconds. In at least some aspects, at least a plurality of the pulses are separated from each other by no more than 20 milliseconds.
In at least some aspects, the pulses are arranged in a plurality of pulse bursts, wherein each of the pulse bursts includes a plurality of the pulses, wherein the pulse bursts are separated from each other by at least 3 microseconds. In at least some aspects, the pulses are monophasic. In at least some aspects, the pulses are multiphasic.
In at least some aspects, the at least one nerve includes a plurality of the nerves and inserting the at least one ablation electrode includes inserting the at least one ablation electrode at different positions along the plurality of the nerves. In at least some aspects, the at least one ablation electrode includes at least one multipolar ablation electrode.
In at least some aspects, the at least one ablation electrode includes a plurality of monoelectrode ablation electrodes. In at least some aspects, applying the pulses includes applying the pulses to at least one set of the monoelectrode ablation electrodes, wherein each of the at least one set includes at least one first monoelectrode ablation electrode that is an active electrode and at least one second monoelectrode ablation electrode that is a return electrode.
Another aspect is a method to treat sacroiliac joint pain. The method includes inserting at least one ablation electrode into a patient to ablate at least one spinal nerve extending from the spinal cord in the vertebral range of the sacral vertebrae or the lumbar vertebrae L3, L4, or L5; and applying pulses to the at least one ablation electrode to ablate the at least one nerve, wherein each of the pulses has a duration of no more than 500 microseconds and at least some of the pulses generate an electric field of at least 3 kV/cm.
Another aspect is a system for treating sacroiliac joint pain. The system includes a memory having instructions stored thereon and a processor configured to execute those instructions to perform actions including applying pulses to at least one ablation electrode to ablate at least one spinal nerve extending from the spinal cord in the vertebral range of the sacral vertebrae or the lumbar vertebrae L3, L4, or L5, wherein each of the pulses has a duration of no more than 500 microseconds and at least some of the pulses generate an electric field of at least 3 kV/cm.
A further aspect is a non-transitory computer-readable medium having stored thereon instructions for treating sacroiliac joint pain, wherein the instructions, when executed by a processor, perform actions including applying pulses to at least one ablation electrode to ablate at least one spinal nerve extending from the spinal cord in the vertebral range of the sacral vertebrae or the lumbar vertebrae L3, L4, or L5, wherein each of the pulses has a duration of no more than 500 microseconds and at least some of the pulses generate an electric field of at least 3 kV/cm.
In at least some aspects, each of the pulses generates an electric field of at least 3.5 kV/cm. In at least some aspects, at least a plurality of the pulses each have a duration of no more than 100 microseconds. In at least some aspects, at least a plurality of the pulses are separated from each other by no more than 20 milliseconds.
In at least some aspects, the plurality of ablation electrodes includes a plurality of monoelectrode ablation electrodes. In at least some aspects, applying the pulses includes applying the pulses to at least one set of the monoelectrode ablation electrodes, wherein each of the at least one set includes at least one first monoelectrode ablation electrode that is an active electrode and at least one second monoelectrode ablation electrode that is a return electrode.
In at least some aspects, the plurality of ablation electrodes includes at least one multipolar ablation electrode including a plurality of the ablation electrodes.
Non-limiting and non-exhaustive embodiments of the present invention are described with reference to the following drawings. In the drawings, like reference numerals refer to like parts throughout the various figures unless otherwise specified.
For a better understanding of the present invention, reference will be made to the following Detailed Description, which is to be read in association with the accompanying drawings, wherein:
The present disclosure is directed to the area of ablation systems and methods of making and using the systems. The present disclosure is also directed to systems and methods of treatment for sacroiliac (SI) joint pain by nerve ablation using short, high voltage pulses.
Many conventional ablation generators for pain management support one or more monopolar ablation electrodes with each monopolar ablation electrode having one conductor. A temperature measurement device, such as a thermocouple, may also be used to monitor the temperature of the tissue or electrode. The return path is provided by a ground pad that is attached to the patient's skin. Some ablation generators for pain management also support bipolar or other multipolar ablation in which the conductive tips of two or more separate monopolar ablation electrodes are placed near each other. One ablation electrode supplies power while another ablation electrode acts as a return. Each ablation electrode requires one channel on the ablation generator. Other arrangements utilize bipolar or other multipolar ablation electrodes.
Examples of ablation generators and ablation systems and methods of making and using the ablation generators and ablation systems can be found at, for example, U.S. Pat. Nos. 8,992,522; 9,039,701; 9,173,676; 9,717,552; 9,956,032; 10,111,703; 10,136,937; 10,136,942; 10,136,943; 10,194,971; 10,342,606; 10,363,063; 10,588,687; 10,631,915; 10,639,098; and 10,639,101; and U.S. Patent Application Publications Nos. 2014/0066917; 2014/081260; 2014/0121658; 2021/0121224; 2021/0236191; 2022/0202484; 2022/0202485; and 2022/0226039 and U.S. Provisional Patent Application Ser. Nos. 63/413,122 and 63/413,133, all of which are incorporated herein by reference in their entireties. In at least some embodiments, these ablation systems can be modified or adapted to perform ablation using short, high voltage pulses, as described herein.
In at least some embodiments, the monopolar or monoelectrode ablation electrode 104 includes an electrode shaft 114, an electrode hub 116, a cable 118 that is electrically coupled to the electrode shaft 114, and a connector 120 for connecting to a port 122 of the ablation generator 102 to energize the electrode shaft 114 via the cable 118 and connector 120. The optional adapter or extension 109 includes a cable 109 and connectors 117a, 117b for coupling the monopolar or monoelectrode ablation electrode 104 to the ablation generator 102. It will be recognized that other ablation systems utilize the monopolar or monoelectrode ablation electrode 104 for ablation instead of, or in addition to, the cannula 106.
The ablation generator 102 can include one or more ports 122 and at least one screen 130. In at least some embodiments, each port 122 is associated with a portion of the screen 130 (or a different screen) and can receive the connector 120 from a monopolar ablation electrode 104. Information such as current, voltage, status, or the like or any combination thereof can be displayed on the screen 130. In at least some embodiments, each port 122 corresponds to an independent channel for operating a monopolar or monoelectrode ablation electrode 104. The ablation generator 102 may also include a ground port 121 for attachment of an optional ground pad 107.
In at least some embodiments, multiple monopolar or monoelectrode ablation electrodes 104 are positioned along the nerve(s) to be ablated. In at least some embodiments, the monopolar ablation electrodes 104 and the ground pad 107 are coupled to the ablation generator 102 to generate ablation lesions sequentially or simultaneously by monopolar ablation. In at least some embodiments, a sequence of ablation periods is performed with two or more lesions generated simultaneously during each ablation period.
In at least some embodiments, the monoelectrode ablation electrodes 104 are used to ablate the nerve(s) in a bipolar manner with monoelectrode ablation electrodes acting as different poles. For example, some of the monoelectrode ablation electrodes 104 are active electrodes and other monoelectrode ablation electrodes are return electrodes. As an example, as illustrated in
In at least some embodiments, a separation distance between the monoelectrode ablation electrodes 104a, 104b is selected to avoid or reduce barotrauma associated with arcing between the monoelectrode ablation electrodes. In at least some embodiments, the ablation system can use multiplexing so that the ablation can occur sequentially for different sets of monopolar or monoelectrode ablation electrodes to allow for positioning the monopolar or monoelectrode ablation electrodes closer together while reducing or avoiding arcing. For example, in the arrangement illustrated in
In at least some embodiments, an ablation system can include one or more multipolar ablation electrodes (i.e., a component with two or more electrodes on the same shaft). A multipolar ablation electrode can include two, three, four, or more electrodes. In at least some embodiments, the ablation generator that was previously coupled to monopolar ablation electrodes can be used or adapted for use with one or more multipolar ablation electrodes. It will also be understood that ablation can be performed using any combination of multipolar and monopolar or monoelectrode ablation electrodes.
The cannula 206 includes a cannula hub 108 and a cannula shaft 110. The cannula shaft 110 is hollow for receiving the multipolar ablation electrode 204. The multipolar ablation electrode 204 includes an electrode shaft 114, a first electrode element 212, a second electrode element 213, an insulative material 215 (which may be part of the electrode shaft) separating the first and second electrode elements, an electrode hub 116, a cable 118 that is electrically coupled to the electrode shaft 114, and a connector 120 for coupling to at least one port 122 of the ablation generator 102 to energize the first electrode element 212 or second electrode element 213 (or both) via the cable 118 and connector 120. (The term “electrode element” is used for clarity when the electrode elements are part of a multipolar electrode. An “electrode element” is an electrode.) In at least some embodiments, the length of the insulative material 215 or the separation distance between the first and second electrode elements 212, 213 is at least 4, 5, or 6 mm. In at least some embodiments, a separation distance between the first and second electrode elements 212, 213 is selected to avoid or reduce barotrauma associated with arcing between the first and second electrode elements. It will be understood that other multipolar ablation electrodes 204 can include three, four, five, six, or more electrode elements. Each adjacent pair of electrode elements of a multipolar ablation electrode 204 is separated by insulative material 215.
Returning to
At least some ablation generators provide a single channel at each port 122. In at least some embodiments, the multipolar ablation electrode 204 uses a separate channel for each of the electrode elements, such as the first and second electrode elements 212, 213. In at least some embodiments, multiple electrode elements may be coupled to the same port 122 so that these electrode elements are either active electrodes or return electrodes simultaneously. In at least some embodiments, the ablation system 200 can include an adapter 209, illustrated in
In at least some embodiments, the ablation system can use multiplexing so that ablation can occur sequentially for different sets of electrode elements 212, 213 to allow for positioning the electrode elements 212, 213 closer together. For example, in the arrangement illustrated in
Nerve ablation can be used to treat pain associated with the sacroiliac (SI) joint pain or other lower back pain including, for example, chronic axial low back pain with confirmed Modic type I or II changes. Such treatments can include ablation of spinal nerves that extend from the spinal cord in the range of the sacral or lumbar vertebrae including, but not limited to, the S1-S4 and L3-L5 vertebrae. In at least some embodiments, the SI joint pain is treated by SI joint denervation by ablating one or more (or all) of the sacral lateral branch nerves innervating the SI joint. In at least some embodiments, the treatment may also include facet joint denervated by ablating the medial branch of a target vertebral level (for example, L4, L5, or S1) and the medial branch of the level above the target vertebral level.
Conventionally, one or more nerves is typically ablated using radiofrequency (RF) energy. In many instances, multiple sites along one or more nerves are ablated to create ablation lesions. Often, these lesions are connected. Conventional ablation treatments typically include thermally ablating the nerve with radiofrequency (RF) energy; however, the delivered energy is controlled to prevent or reduce thermal damage to other tissues, such as the spinal cord or other nearby nerves or tissue. Accordingly, RF-based ablation treatment can require a substantial amount of time to be effective. Such time is typically at least 1-3 minutes or more per ablation site. RF-based ablation treatments may also be time consuming to assure that ablation electrodes are properly positioned and the ablation lesions are fully connected. Local tissue electrical properties (including the properties of fat near the nerves) may hinder the creation of bipolar ablation lesions and reduce the efficacy of the procedure.
In contrast to conventional thermal ablation, short, high voltage pulses can be used for nerve ablation to treat SI joint pain or other lower back pain. Using short, high voltage pulses can reduce the procedure time and create continuous lesions with only seconds of application of the pulses. Although no particular theory is necessary for practicing the invention, it is believed that the short, high voltage DC pulses, which can generate locally high electric fields, cause electroporation of the nerve cells. This results in disruption of the cell by generating pores in the cell membrane. The electroporation of the nerve cells produces irreversible damage that results in cell death or destruction. It is believed that, if the applied electric field at the membrane is larger than a threshold value, the electroporation is irreversible and the pores remain open. This allows exchange of material across the membrane and leads to necrosis or cell death.
Because the high voltage pulses are applied for a much shorter time (for example, in a window of no more than 10 seconds), the total amount of localized heating can be much less than for the conventional RF-based nerve ablation. Accordingly, damage to other surrounding tissue is avoided or substantially reduced. This is particularly important for nerve ablation due to the proximity of the ablated nerves to the spinal cord and other nerves.
Nerve cells are particularly resistant to electroporation. In at least some instances, the nerve cells have a higher threshold to electroporation and require a higher electric field (in at least some embodiments, at least 3800 V/cm) to electroporate than other cells. For example, in at least some instances, the nerve cells require at least nine times the electric field to electroporate than myocardial cells or at least twice the electric field to electroporate than red blood cells, vascular smooth muscle cells, or endothelial cells. There may be concern regarding the use of such high voltage pulses near the spinal cord or other sensitive tissues. In at least some embodiments, the size of the irreversible ablative zone of the electric field can be managed (for example, through electrode design or ablation parameters) for irreversible ablation of the target nerve but not surrounding structures.
In at least some embodiments, the voltage of the pulses is at least 1, 1.5, 2, 2.5, 3, 3.5, 3.8, 4, 4.5, or 5 kV. In at least some embodiments, the pulses generate an electric field of at least 3.5, 3.8, 4, 4.5, or 5 kV/cm. In at least some embodiments, a time window for delivery of a treatment set of short, high voltage DC pulses is no more than 100, 150, 200, 250, 300, 500, or 750 milliseconds or 1, 2, or 5 seconds. In at least some embodiments, a single treatment set of short, high voltage DC pulses is sufficient for nerve ablation. In other embodiments, two, three, four, five, or more treatment sets of short, high voltage DC pulses are used for the nerve ablation. In at least some embodiments, the time between treatment sets is at least 1, 2, 5, 10, 20, 30, 45, or more seconds and may be measured in minutes or may be longer. In at least some embodiments, the time between treatment sets may allow for heat dissipation or to charge the capacitors of the ablation generator or any combination thereof.
A treatment set of pulses includes multiple pulses that are delivered during the treatment time window. The pulses can be monophasic, biphasic, or multiphasic. In at least some embodiments, an interphase time delay for a biphasic or multiphasic pulse is no longer than the duration of one phase of the pulse. In at least some embodiments, the time duration for each of the pulses is no more than 0.5, 1, 5, 10, 20, 50, 100, 200, or 500 nanoseconds or 1, 5, 10, 20, 50, 100, 200, 300, or 500 microseconds. In at least some embodiments, the time duration of each of the pulses is at least 0.5, 1, 5, 10, 20, 50, 100, 200, or 500 nanoseconds or 1, 5, 10, 20, 50, 100, 200, or 300 microseconds. The number of pulses in a treatment set of pulses may be at least 10, 20, 50, 100, 200, 500, 1000 or more.
In at least some embodiments, the pulses are rectangular or any other suitable pulse shape. In at least some embodiments of rectangular or other pulses, the rise or fall periods of the pulse may not result in sharp increases/decreases. Such rise or fall periods may be used to, for example, manage overshoot or ringing effects.
In at least some embodiments, the pulses can be arranged in pulse bursts with each pulse burst containing at least 2, 5, 10, 15, 20, 25, 30, 40, 50, 100, or more pulses. The pulses of the pulse burst are separated from each other by a period that, at least in some instances, is no more than 1, 10, 50, 100, 200, 500, or 1000 microseconds. In at least some embodiments, the pulses of a pulse burst (or pulses that are not in a pulse burst arrangement) are separated from each other by at least 0.5, 1, 10, 20, 50, 100, 200, or 500 microseconds. In at least some embodiments, the pulses of a pulse burst (or pulses that are not in a pulse burst arrangement) are separated from each other by no more than 1, 10, 20, 50, 100, 200, 500, or 1000 microseconds. In some embodiments, each of the pulses in a pulse burst are identical in phase, identical in duration, or both. In other embodiments, at least two of the pulses differ from each other in the number of phases, duration, or both.
In at least some embodiments, the time window includes multiple pulse bursts, for example, at least 2, 4, 5, 10, or more pulse bursts. In some embodiments, each of the pulses bursts is identical in the number of pulses, the period between pulses, or both. In other embodiments, at least two of the pulse bursts may differ from each other in the number of pulses, the period between pulses, or both.
In at least some embodiments, the pulse bursts are separated from each other by a burst period that, at least in some instances, is no more than 3, 10, 50, 100, 200, 500, or 1000 microseconds and is at least 3, 10, 50, 100, 200, or 500 microseconds. In at least some embodiments, the burst period is at least 3, 4, 5, or 10 times longer than the period between the individual pulses of a burst.
In at least some embodiments, there may be higher levels of aggregation of pulses or pulse bursts. U.S. Pat. No. 10,709,502, incorporated herein by reference in its entirety, discloses examples of pulse arrangements for tissue ablation.
In at least some embodiments, the values for the delivery parameters described above are selected based on one or more factors such as, for example, efficacy, treatment duration, treatment outcomes, patient pain, damage to tissues other than the SI joint, tissue heating, generation of bubbles in body fluids, skeletal muscle stimulation, arcing, tissue aggregation, or the like or any combination thereof.
In at least some embodiments, one or two ablation electrodes 104/204 are inserted into the body of the patient and positioned near the nerve(s) to be ablated. In at least some embodiments, the ablation electrode(s) 104/204 is/are positioned at a particular distance away from the spinal cord 448 to avoid hearing or damage to the spinal cord.
After insertion of the ablation electrode(s) 104/204, short, high voltage pulses are then applied to the nerve(s) to form ablation lesions, as described above. After treatment, the ablation electrode(s) 104/204 are removed from the patient's body.
Any suitable memory 160 can be used. The memory 160 illustrates a type of computer-readable media, namely computer-readable storage media. Computer-readable storage media may include, but is not limited to, nonvolatile, non-transitory, removable, and non-removable media implemented in any method or technology for storage of information, such as computer readable instructions, data structures, program modules, or other data. Examples of computer-readable storage media include RAM, ROM, EEPROM, flash memory, or other memory technology, CD-ROM, digital versatile disks (“DVD”) or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information and which can be accessed by a computer.
Communication methods provide another type of computer readable media; namely communication media. Communication media typically embodies computer-readable instructions, data structures, program modules, or other data in a modulated data signal such as a carrier wave, data signal, or other transport mechanism and include any information delivery media. The terms “modulated data signal,” and “carrier-wave signal” includes a signal that has one or more of its characteristics set or changed in such a manner as to encode information, instructions, data, and the like, in the signal. By way of example, communication media includes wired media such as twisted pair, coaxial cable, fiber optics, wave guides, and other wired media and wireless media such as acoustic, RF, infrared, and other wireless media.
The memory 160 can have instructions stored thereon. The instructions, when executed by the processor 162 can perform actions. Such actions can include, for example, applying pulses to the ablation electrode to ablate the sacroiliac joint nerve within the vertebral body. The instructions may include parameter values, such as pulse duration, pulse voltage, the electric field generated by the pulses, the number of pulses, the separation time between pulses, the number of pulse bursts, the number of pulses in a pulse burst, the separation time between pulse bursts, and the like or any combination thereof.
The display 130 can be any suitable display, such as a monitor, screen, display, or the like. The input interface 164 can be, for example, keys, a touchpad, a keyboard, a mouse, a touch screen, a track ball, a joystick, a voice recognition system, another device that is in communication with the ablation generator 102, or any combination thereof, or the like and can be used by the user to interact with a user interface of the ablation generator 102.
The input interface 164 allows a user to program or alter parameter values of the ablation generator 102 for delivery of the short, high voltage pulses, as described herein. In at least some embodiments, the user can program the ablation generator 102 prior to a procedure. In at least some embodiments, the user can input or alter parameter values during a procedure.
The above specification provides a description of the structure, manufacture, and use of the invention. Since many embodiments of the invention can be made without departing from the spirit and scope of the invention, the invention also resides in the claims hereinafter appended.
This application claims the benefit under 35 U.S.C. § 119 (e) of U.S. Provisional Patent Application Ser. No. 63/522,372, filed Jun. 21, 2023, which is incorporated herein by reference.
Number | Date | Country | |
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63522372 | Jun 2023 | US |