Inner branch smart tip needle

Abstract

To provide cryogenic methods, systems, and apparatus for relieving lower back pain in patients. [Solution] The cryogenic apparatus includes a handpiece having a size and shape suitable for support by an operator's hand, and a needle probe 110 coupled to the distal portion of the handpiece. The needle probe 110 includes a probe body, at least one needle 115 coupled to the probe body, and a silica supply tube extending into the needle lumen. The system includes an introducer configured to receive the needle 115 and position the needle 115 in close proximity to the location of target tissue associated with lower back pain, and the cryogenic apparatus is configured to provide a desired ice ball shape that remains on the distal portion of the introducer after the needle 115 has been removed from the introducer. The system further includes a needle guard 150 configured to house the needle probe 110.

Description

Technical Field

[0001]

[0001] Cross - reference to Related Applications This application claims the priority of U.S. Patent Application No. 19 / 013,766, filed on January 8, 2025, the disclosure of which is hereby incorporated by reference in its entirety for all purposes.

Background Art

[0002]

[0001] The present disclosure generally relates to medical devices, systems, and methods for cryotherapy. More specifically, the present disclosure relates to cryogenically cooling a patient's target tissue to denature, inhibit, reshape, or otherwise affect the target tissue to achieve a desired change in its behavior or composition. Cryogenic cooling of nerve tissue has been shown to be effective in treating various medical conditions, including, among other things, pain (e.g., occipital neuralgia and other neuropathic pains, neuromas, osteoarthritis), spasticity, and joint stiffness. For example, it has been found that by cooling nerve tissue, the nerves that cause these symptoms can be denatured or inhibited.

[0003]

[0002] Based on the above, cryogenic devices with needle probes have emerged as a way to therapeutically cool target tissues to treat various medical conditions. The needle probes of such devices are typically inserted into the patient's skin adjacent to the target tissue. Some cryogenic devices may include a cryogen source such that the cryogen can be injected into the target tissue through an opening in the needle of the cryogenic device's needle probe so that the target tissue is directly cooled by the cryogen. Other cryogenic probes may include a closed needle tip, in which case the needle can be cooled (e.g., by the flow of cryogen), whereby the target tissue adjacent to the cooled needle can be cooled by conduction. These cryogenic probes have proven effective in generating a cryozone in or around the target tissue within the patient with accuracy, convenience, and reliability.

Summary of the Invention

[0004]

[0003] This disclosure of the present invention relates to improved cryogenic medical devices, systems, and methods. Many of the devices and systems described herein would be beneficial for cryotherapy of nerves associated with back pain. Various features and advantages of such cryogenic systems and methods are described herein.

[0005]

[0004] According to one embodiment, a cryogenic device for treating a patient's target tissue includes a handpiece having a size and shape suitable for being supported by an operator's hand and including at least one cooling fluid supply path located within the handpiece, and a needle probe coupled to the distal portion of the handpiece. The needle probe includes a probe body, a blunt needle coupled to the probe body, the blunt needle having a proximal end, a distal end, and a needle lumen between the proximal and distal ends, and a silica supply tube extending into the needle lumen and coupled to at least one cooling fluid supply path. In particular, the silica supply tube has an inner diameter and an outer diameter, and the ratio of the inner diameter to the outer diameter of the silica supply tube is configured to provide a desired ice ball shape. Advantageously, by varying the diameter of the silica tube and the ratio of the needle's outer diameter to its inner diameter, it is possible to achieve desired ice ball shapes (e.g., teardrop shape) while simultaneously avoiding undesirable ice ball shapes (e.g., round ice balls may be undesirable depending on the application) and / or needle frost formation, particularly when designing longer needles (e.g., 175-180 mm) with reduced gauge sizes (e.g., 25 G) for low back pain and spinal indications. The desired ice ball shape is based at least partially on the needle approach and the anatomical size of the target nerve. For example, it is desirable to ensure complete coverage of the nerve, thereby completely enclosing them within the ice ball.

[0006]

[0005] The cryogenic apparatus may include a variety of optional embodiments. The desired ice ball shape may be teardrop-shaped. Such ice balls are uniquely suited to treating the various conditions described herein. For example, various embodiments of this disclosure may be applied to the treatment of the medial branch and sacroiliac joint (SI joint). The ratio of the inner diameter to the outer diameter of the silica supply tube is in the range of 0.44 to 0.52. The flow rate of the cooling fluid is further configured to provide the desired ice ball shape at the distal end of the blunt needle. The flow rate is typically in the range of 4.70 to 8.34 SCCM (standard cubic centimeters / min).

[0007]

[0006] The gauge of the blunt needle may be 25G or greater. The blunt needle may have a length of 175mm or greater. In other embodiments, the gauge and / or length of the needle may be less than those listed herein and may be used with a larger and / or shorter introducer cannula to accommodate the needle.

[0008]

[0007] The target tissue may include various nerves associated with lower back pain, such as medial branch nerves. The target tissue may further include the sacroiliac joint. The target tissue may further include vertebral nerves.

[0009]

[0008] According to various embodiments, at least a portion of the blunt needle is conductive for performing nerve stimulation and identifying target tissue. The blunt needle may not include a dielectric outer coating (e.g., parylene, PET, etc.) as it may be introduced close to the target tissue via a sharp, straight or curved introducer (e.g., 18G-20G) that both positions the blunt needle and provides insulation when nerve stimulation is performed. The apparatus may further include a needle guard configured to house the needle probe, including the blunt needle, for patient safety, to reduce biohazards, and / or to maintain electrical connection with the nerve stimulator during the therapeutic procedure. The apparatus may further include an access cover configured to seal internal ports of the cryogenic apparatus to improve electrical safety and cybersecurity.

[0010]

[0009] According to another embodiment, a cryogenic device for treating a patient's target tissue includes a handpiece having a size and shape suitable for being supported by an operator's hand and including at least one cooling fluid supply path located within the handpiece, and a needle probe coupled to the distal portion of the handpiece. The needle probe includes a probe body and a blunt needle coupled to the probe body, the blunt needle having a proximal end, a distal end, and a needle lumen between the proximal and distal ends. The blunt needle has a length of 175 mm or more and a gauge of 25 G or more, and the needle probe further includes a silica supply tube extending into the needle lumen and coupled to at least one cooling fluid supply path. The silica supply tube has an inner diameter and an outer diameter, and the ratio of the inner diameter to the outer diameter of the silica supply tube is configured to provide a desired teardrop-shaped ice ball (e.g., 15.5 mm in length and 7.05 mm in width).

[0011]

[0010] According to yet another embodiment, a cryogenic system for alleviating a patient's lower back pain includes a cryogenic device comprising a handpiece having a size and shape suitable for being supported by an operator's hand and having at least one cooling fluid supply path located within the handpiece, and a needle probe coupled to the distal portion of the handpiece. The needle probe comprises a probe body, at least one needle coupled to the probe body, the at least one needle having a proximal end, a distal end, and a needle lumen between the proximal and distal ends, and a silica supply tube extending into the needle lumen and coupled to at least one cooling fluid supply path. The system further includes an introducer configured to receive at least one needle and to position at least one needle in close proximity to the location of a target tissue associated with the lower back pain. The cryogenic device is configured to provide a desired ice ball that remains on the distal portion of the introducer after at least one needle has been removed from the introducer.

[0012]

[0011] According to various embodiments, the introducer is configured to minimize post-cooling time with the cryogenic device by allowing the ice ball to melt while remaining on the introducer. For example, the total time of a typical cryotherapy procedure (pre-cooling, cooling, post-cooling) can be reduced by about 20 percent compared to other cryotherapy regimens (e.g., 106 seconds to 86 seconds), where the post-cooling time can be reduced by more than 50 percent compared to other cryotherapy regimens (e.g., 45 seconds to 15 seconds), as the introducer remains attached to the ice ball until the ice ball melts, during which time the healthcare worker is free to treat the next treatment site using the removed cryogenic device. Advantageously, this continuous process (e.g., treating a second treatment site while the introducer remains attached to the ice ball at a first treatment site) helps to reduce the overall treatment time by reducing the post-cooling time between treatments of multiple sites. Introducers may include gauge sizes in the range of 15G to 20G, but larger introducer cannulas may be used to accommodate larger needle gauges.

[0013]

[0012] The system may include a variety of optional embodiments. The system may further include a needle guard configured to house a needle probe. The needle guard may be detachably coupled to the needle probe via a gripping mechanism. The needle guard and needle probe may be detachably coupled to the handpiece while the needle guard and needle probe remain coupled to each other via a coupling mechanism. The coupling mechanism may be located on the inner and outer surfaces of the needle guard. Conveniently, the needle guards provided herein are configured to be coupled to or detached from the handpiece, depending on the preference of the healthcare professional, the stage of treatment, etc.

[0014]

[0013] According to various embodiments, the system may further include a nerve stimulator configured to be electrically coupled to the probe body of a needle probe. The needle guard is configured to accommodate at least one needle (e.g., via a slotted mechanism) when the cable of the nerve stimulator is coupled to the needle probe. Thus, the medical professional can safely and easily move the needle probe during the procedure without having to disconnect or reconnect the electrical connection each time for nerve stimulation, which also reduces the procedure time. It may not be necessary to connect the handpiece to the needle probe during the nerve stimulation phase. Furthermore, the medical professional can engage and disengage the needle guard while maintaining an electrical connection with the nerve stimulator. The needle guard may further include a slotted mechanism on the needle guard for receiving a connector for the cable of the nerve stimulator. The system may further include an access cover configured to seal the internal ports of the cryogenic device. The access cover electrically isolates the components of the cryogenic device from the therapeutic environment. The access cover provides additional cybersecurity as a special tool may be required to remove the access cover and access the internal ports of the cryogenic device.

[0015]

[0014] According to at least some embodiments, the target tissue may include medial branch nerves. The target tissue may include vertebral nerves. The target tissue may include sacroiliac joints.

[0016]

[0015] According to another embodiment, a method for treating a patient's lower back pain includes providing a cryogenic apparatus comprising a handpiece having a size and shape suitable for being supported by an operator's hand and including at least one cooling fluid supply path disposed within the handpiece, and a needle probe coupled to the distal portion of the handpiece. The needle probe comprises a probe body, at least one needle coupled to the probe body, the at least one needle having a proximal end, a distal end, and a needle lumen between the proximal and distal ends, and a silica supply tube extending into the needle lumen and coupled to at least one cooling fluid supply path. The silica supply tube has an inner diameter and an outer diameter, and the ratio of the inner diameter to the outer diameter of the silica supply tube is configured to provide a desired ice ball. The method further includes identifying the location of the treatment zone by reference to a skin surface adjacent to a target tissue associated with lower back pain; inserting at least one needle of a cryogenic device through an introducer through the skin surface to a first location in the treatment zone; and operating the cryogenic device such that at least one needle generates a desired ice ball adjacent to the target tissue, thereby relieving or reducing the severity of pain. Advantageously, at least one needle can be removed from the introducer at the first location in the treatment zone, leaving the ice ball attached to the distal portion of the introducer at the first location in the treatment zone until the ice ball melts.

[0017]

[0016] The method may include a variety of optional embodiments. The method may include inserting the introducer through the skin surface to a first location in the treatment zone before inserting at least one needle of the cryogenic device through the introducer to a first location in the treatment zone. The method may further include inserting at least one needle of the cryogenic device through the introducer to a second location in the treatment zone, and operating the cryogenic device to generate a second ice ball in close proximity of at least one needle to the target tissue, thereby relieving or reducing the severity of pain. At least one needle may be removed from the introducer at the second location in the treatment zone, and the second ice ball remains attached to the distal portion of the introducer at the second location in the treatment zone.

[0018]

[0017] According to various embodiments, identifying the location of the treatment zone may include stimulating a nerve with the conductive surface of at least one needle. Inserting at least one needle of the cryogenic device through the skin via an introducer may include inserting at least one needle until the proximal end of at least one needle is coplanar with the proximal end of the introducer.

[0019]

[0018] According to at least some embodiments, the target tissue may include medial branch nerves. The target tissue may include vertebral nerves. The target tissue may include sacroiliac joints.

[0020]

[0019] According to various embodiments, the cryogenic device further includes a needle guard for housing at least one needle. The needle guard may include a slotted mechanism for receiving a connector for the cord of a nerve stimulator, such that the cord remains coupled to the probe body throughout the treatment. Advantageously, the healthcare professional may leave the nerve stimulator coupled to the cryogenic device throughout the treatment without needing to disconnect or reconnect it. Furthermore, by pressing down the coupling mechanism on the needle guard, it may be possible to remove both the probe body and the needle guard from the handpiece simultaneously for safe and hygienic disposal.

Brief Description of the Drawings

[0021] [Figure 1] An exemplary embodiment of a cryogenic device including a probe receptacle and a needle probe according to an embodiment of the present disclosure is shown. [Figure 2A] A needle probe decoupled from the probe receptacle of FIG. 1 according to an embodiment of the present disclosure is shown. [Figure 2B] A needle probe coupled to the probe receptacle of FIG. 1 according to an embodiment of the present disclosure is shown. [Figure 3] A disassembled view of the needle probe of FIG. 1 according to an embodiment of the present disclosure is shown. [Figure 4] An exemplary ice ball formed by the needle probe of FIG. 1 according to an embodiment of the present disclosure is shown. [Figure 5] The needle guard and the needle probe of FIG. 1 according to an embodiment of the present disclosure are shown. [Figure 6] A perspective view of the needle guard of FIG. 1 according to an embodiment of the present disclosure is shown. [Figure 7A] A view facing the outside of the access cover of the cryogenic device according to an embodiment of the present disclosure is shown. [Figure 7B] A view facing the inside of the access cover of the cryogenic device according to an embodiment of the present disclosure is shown. [Figure 8] A needle and introducer system for providing cryogenic treatment to a target tissue according to an embodiment of the present disclosure is shown. [Figure 9] A flowchart of a method for treating low back pain experienced by a patient according to an embodiment of the present disclosure is shown. [Figure 10] An anatomical view showing exemplary target tissues and treatment locations according to some embodiments of the present disclosure is shown. [Figure 11] An anatomical view showing exemplary target tissues and treatment locations according to some embodiments of the present disclosure is shown.

Modes for Carrying Out the Invention

[0022]

[0033] The present invention provides improved medical devices, systems, and methods. Embodiments of the present invention can optionally treat pain associated with lower back pain and / or various spinal conditions by treating target tissues located in and beneath the skin. In some embodiments, the systems, devices, and methods of the present disclosure may utilize integrated hypothermia and nerve stimulators for the localization and treatment of target nerves.

[0023]

[0034] In various embodiments described herein, nerve or tissue localization techniques may be used. In the case of peripheral nerves, electrical stimulation or ultrasound may be used to localize the target nerve to be treated. Electrical nerve stimulation can identify the stimulated nerve and, in the case of motor nerves, identify either the innervated muscle contraction or, in the case of sensory nerves, sensory changes within a specific area. Ultrasound imaging or fluoroscopy may be used to visualize nerves and nerve-related structures (e.g., blood vessels) to assist in positioning the cryoprobe close to the target nerve. By positioning the patient's skeletal structure in a predetermined position (e.g., with the knee bent at 30 degrees or fully extended), bones, ligaments, cartilage, muscles, soft tissues (including fascia), vascular structures, and peripheral nerves can be reliably localized. The skeletal structure can then be localized using external palpation, thereby localizing the pathway and relative depth of the peripheral nerve to be targeted for treatment. Embodiments of electroneural stimulation for localizing target nerves are disclosed in International Publication No. WO2019099677A1 by the same applicant, which is incorporated herein by reference in its entirety.

[0024]

[0035] Sensory nerves and associated tissues can be temporarily impaired in function using moderately cool temperatures of 10°C to -5°C without permanently rendering the tissue structure inoperable. Using approaches similar to those employed for identifying structures associated with atrial fibrillation or for peripheral nerve blocks, target tissue structures can be identified using needle probes or other therapeutic devices in these moderate-temperature diagnostic modes. Furthermore, using the same probe (or different probes), the target tissue zone can be selectively treated, and / or a more long-term or permanent treatment can be provided by inducing apoptosis at temperatures of approximately -5°C to approximately -50°C. In some embodiments, apoptosis can be selectively induced using therapeutic temperatures of approximately -1°C to approximately -15°C, or approximately -1°C to approximately -19°C, to provide a longer-term treatment that limits or avoids inflammation and the recruitment of skeletal muscle satellite repair cells. In some embodiments, axonal rupture with Wallerian degeneration of sensory nerves, which can be induced using therapeutic temperatures of approximately -20°C to approximately -100°C, is desirable. Therefore, the duration of therapeutic efficacy of such subcutaneous cryotherapy can be selected and controlled by lower temperatures, longer treatment times, and / or larger volumes of the target tissue, or by a chosen pattern, which determine the persistence of the treatment.Further descriptions of cryogenic cooling methods and apparatus can be found in U.S. Patent No. 7,713,266, “Subdermal Cryogenic Remodeling of Muscle, Nerves, Connective Tissue, and / or Adipose Tissue (Fat),” U.S. Patent No. 7,850,683, “Subdermal Cryogenic Remodeling of Muscles, Nerves, Connective Tissue, and / or Adipose Tissue (Fat),” U.S. Patent No. 9,039,688, “Method for Reducing Hyperdynamic Facial Wrinkles,” and U.S. Patent No. 8,298,216, “Pain Management Using Cryogenic Remodeling,” all of which are incorporated herein by reference.

[0025]

[0036] This disclosure describes cryogenic devices that may be used to administer cryotherapy to patients. In some embodiments, the described cryogenic devices may include needles for administering cryotherapy subcutaneously to specific tissues targeting a variety of conditions. For example, the cryogenic device may include needles configured to be inserted near peripheral nerves to administer cryotherapy to peripheral nerves to treat pain, spasticity, or other such conditions that may be improved by such therapy. Further information regarding the use of cryotherapy for the relief of pain or spasticity can be found in U.S. Patent No. 8,298,216 filed November 14, 2008 (Agent No. 000810US), U.S. Patent No. 9,610,112 filed March 18, 2014 (Agent No. 004311US), U.S. Patent No. 10,085,789 filed March 13, 2017 (Agent No. 004321US), and U.S. Patent Application Publication No. 20190038459 filed September 14, 2018 (Agent No. 004331US), the full disclosures thereof are incorporated herein by reference in their entirety for all purposes. Cryogenic devices may also be used for prophylactic treatment, such as the destruction or prevention of neuromas, as described, for example, in U.S. Patent No. 10,470,813 filed on March 14, 2016 (Agent Reference No. 004510US), the full disclosure thereof, which is incorporated herein by reference in whole for all purposes.

[0026]

[0037] Figure 1 shows an exemplary embodiment of a cryogenic device 100, which includes a cartridge holder 140 for holding a cryogenic agent cartridge 130 and a needle probe 110. As shown in the illustrated exemplary embodiment, the cryogenic device 100 may be a self-contained handpiece suitable for being grasped and operated by an operator's hand. In other embodiments, the cryogenic device may include physically separated components. For example, the cryogenic device 100 may include a handpiece including a needle probe 110 and a cryogenic agent cartridge 130 separated from the handpiece. As described herein, in some embodiments, the cryogenic device 100 may have a multi-part (e.g., two-part) housing, and the needle probe 110 is located in a separate probe housing which can be coupled to the housing of the handpiece portion. In other embodiments, the needle probe 110 does not have to be located in a separate housing and may be configured to be inserted directly into the housing of the cryogenic device 100. As an example, the cryogenic device 100 in at least some of these embodiments may have a single housing.

[0027]

[0038] In some embodiments, the cryogenic agent cartridge 130 may be a disposable cartridge filled with a cryogenic agent (e.g., nitrous oxide, fluorocarbon refrigerant, and / or carbon dioxide). In some embodiments, the cryogenic apparatus 100 may include a cartridge door 120 for accessing the cryogenic agent cartridge 130 (e.g., to replace the cryogenic agent cartridge 130). The cartridge door 120 may be configured to move from an open position, allowing a cartridge holder 140 to receive the cryogenic agent cartridge 130, to a closed position, securing the cryogenic agent cartridge 130 within the housing of the cryogenic apparatus 100. For example, the cartridge door 120 may be configured to pivot around a pivot point to allow access to the cryogenic agent cartridge 130. In this example, the user may open the cartridge door 120 (for example, when the user notices that the cryogenic agent cartridge 130 is empty, or is otherwise warned), remove the cryogenic agent cartridge 130 from the cartridge holder 140, insert a new cryogenic agent cartridge 130 into the cartridge holder 140, and close the cartridge door 120, as shown in Figure 1. The exemplary configuration of the cartridge door 120 and cartridge holder 140 described is designed with user convenience in mind. The cartridge door 120 can be quickly swung open with minimal effort, and a replacement cryogenic agent cartridge 130 can be easily inserted. This can be particularly advantageous when the operator must replace the cryogenic agent cartridge 130 during a procedure. For example, in some cases, the operator may need to replace the cryogenic agent cartridge 130 during a treatment cycle after the needle 115 of the needle probe 110 has already been inserted into the patient's skin (for example, if the cryogenic agent is depleted during the treatment cycle). In this example, the cartridge door design described may allow the operator to leave the needle 115 in the patient's skin while replacing the cryogenic agent cartridge 130. As a result, the operator does not need to spend time and effort repositioning the needle 115 to the desired position.In some embodiments, the cryogenic device 100 may include a valve between the cryogenic cartridge 130 and the cryogenic pathway to seal the cryogenic agent in the cryogenic cartridge 130 from the cryogenic pathway (for example, when a treatment cycle is not being performed).

[0028]

[0039] In some embodiments, as shown in Figure 1, the cryogenic device 100 may include a probe receptacle 170 configured to receive a needle probe 110. In some embodiments, the probe receptacle 170 may be perforated within the chassis 105 of the cryogenic device, and the chassis 105 may include at least a portion of the cryogenic agent pathway. For example, the chassis 105 may include one or more lumens coupled to the outlet of the cryogenic agent cartridge 130, and one or more lumens of the chassis 105 may be coupled to the probe receptacle. In some embodiments, the chassis 105 may include the entire cryogenic agent pathway (e.g., from the outlet of the cryogenic agent cartridge 130 to the probe receptacle 170) within the handpiece portion of the cryogenic device 100. In some embodiments, the inner surface of the chassis 105, or at least the cryogenic agent pathway formed by the chassis 105, may be made of a metallic material. The metallic material may be configured to reduce the number of nucleation sites and reduce or prevent the formation of bubbles due to the vaporization of the cryogenic agent. As an example, the metallic material may be aluminum (or an aluminum alloy). Data show that, due to the inherent properties of aluminum and aluminum alloys, metallic materials including aluminum may be particularly suitable for reducing or preventing bubble formation due to the vaporization of the cryogenic agent (for example, as the cryogenic agent flows along the cryogenic agent path). In other embodiments, instead of a metallic material, a specific polymer or plastic material may be selected based on the determination that the material has a small number of nucleation sites. By reducing bubble formation, the need to prime the cryogenic apparatus 100 is reduced, thereby reducing the waste of cryogenic agent (and the time spent) when priming the apparatus. Experimental data also show that reducing the length of the cryogenic agent path had the effect of reducing bubble formation as well. Thus, the length of the cryogenic agent path in the cryogenic apparatus 100 can be shortened, for example, by an optimized apparatus design that positions the cryogenic agent cartridge 130 close to the needle probe 110, and by an optimized cryogenic agent path that takes the shortest possible path between the cryogenic agent cartridge 130 and the needle probe 110.In some embodiments, the needle probe 110 may be removable and / or disposable. In some embodiments, the operator may attach or remove needle probes of different probe types. For example, the operator may attach a first needle probe having a three-needle configuration and perform a first treatment, then remove the first needle probe and replace it with a second needle probe having a different needle configuration.

[0029]

[0040] In some embodiments, the needle probe 110 may be releasably coupled to the probe receptacle 170 so that the needle 115 can be replaced after use with a sharper needle or a needle having a different configuration. In exemplary embodiments, the needle 115 may be screwed into the needle probe 110, press-fitted into an aperture within the needle probe 110, or have a quick disconnect, such as a retaining mechanism for engaging the needle probe 110 with the probe receptacle. For example, the needle 115 may be bonded to the needle probe 110 with a thermosetting epoxy adhesive. A quick disconnect mechanism may be a useful safety mechanism in the event that the cryogenic device 100 fails to operate (e.g., valve failure). The quick disconnect may allow the operator to disengage the needle 115 and the cryogenic device 100 from the patient's tissue without exposing the patient to the coolant when the system is depressurized.

[0030]

[0041] The processor or controller 122 will typically comprise a programmable electronic microprocessor that embodies machine-readable computer code or programming instructions for performing one or more of the treatment methods described herein. The microprocessor will typically include, or be coupled to, memory (such as non-volatile memory, flash memory, read-only memory ("ROM"), or random access memory ("RAM")) for storing the computer code and the data used thereby, and / or a recording medium (such as a solid-state recording medium like a flash memory drive, a magnetic recording medium like a hard disk or floppy disk, or an optical recording medium like a CD or DVD). Suitable interface devices (such as a digital-to-analog converter or an analog-to-digital converter), as well as input / output devices (such as a USB or serial I / O port, a wireless communication device, and a graphical display card), may also be provided. A wide variety of commercially available or proprietary processor structures may be used in different embodiments, and a suitable processor may utilize a wide variety of combinations of hardware and / or hardware / software combinations. For example, the processor 122 may be integrated onto a single processor board, run a single program, or utilize multiple boards to run several different program modules in a wide variety of alternative distributed data processing or code architectures.

[0031]

[0042] In the exemplary embodiments shown herein, the needle probe is shown having one needle. Those skilled in the art will understand that the needle probe may have any suitable number of needles (e.g., one needle, two needles, three needles, four needles, five needles, or more). When multiple needles are used, they may be arranged in any number of patterns. For example, a single linear array may be used, or a two-dimensional or three-dimensional array may be used. Examples of two-dimensional arrays include any number of rows and columns of needles (e.g., rectangular array, square array, elliptical, circular, triangular, etc.), and examples of three-dimensional arrays include those where the needle tips are at different distances from the probe hub, such as an inverted pyramidal shape.

[0032]

[0043] According to at least some embodiments of this disclosure, the needle 115 is a blunt needle. According to at least some embodiments, the needle 115 may be a blunt needle of 25G or greater. Furthermore, the length of the needle may be 175 mm or greater. In exemplary embodiments, the needle gauge may be larger and the length shorter, provided that the ID / OD ratio is in the range of 0.756 or greater and 0.85 or less. The manufacture of the needles described herein (e.g., doubling the needle length while reducing the gauge size) was a particularly challenging endeavor. Advantageously, the needle 115 includes a silica tube, which is described in more detail below, and the diameter of the silica tube and the ratio of the needle outer diameter to the needle inner diameter are varied to form a needle for obtaining a teardrop-shaped ice ball (as shown in Figure 4) while avoiding undesirable ice ball shapes and frost on the needle. The needle 115 allows a healthcare professional to position the center of the ice ball distal to the end of the needle. For example, the tip geometry, characterized by a blunt design and the disclosed silica length, ensures a safer and more effective cryoneurolysis treatment of the target nerve. Furthermore, the needle 115 can be formed using a special welding technique that minimizes the use of material and excess mass at the very distal tip of the needle 115. The inventors were able to balance the flow rate (and exhaust or aeration) to match the desired therapeutic dose (temperature / time).

[0033]

[0044] Advantageously, the length of the needle 115 is sufficient to treat target peripheral nerves, such as nerves associated with low back pain, including lumbar facet joints with medial branch nerves (e.g., peripheral spinal nerves). For example, the length of the needle 115 is suitable for reaching deep medial branch nerves. By doubling the length of the needle 115 (compared to other treatment systems) and reducing the needle gauge to 25G or more, a teardrop-shaped or elongated ice ball (e.g., having a larger volume toward the distal tip of the needle 115) is formed, as shown in Figure 4. Such ice balls are uniquely suited to treating the various symptoms described herein. For example, various embodiments of this disclosure may be applied to the treatment of the sacroiliac joint (SI joint), where a longer ice ball (compared to a rounder, more symmetrical ice ball) is preferred for treating nerves within the SI joint. In various embodiments, the ice ball may be circular, elliptical, slotted, etc.

[0034]

[0045] Embodiments of this disclosure, though not limited thereto, can be applied to a variety of nerve targets, including the supraorbital and trigeminal nerves, suprascapular nerve, genitofemoral nerve, ilioinguinal nerve, iliohypogastric nerve, lateral femoral cutaneous nerve, and pudendal nerve, sural nerve, saphenous nerve, and superficial peroneal nerve, infrapatellar saphenous nerve, anterior femoral cutaneous nerve, and deep geniculate nerve, and medial lumbar branch nerves. Furthermore, embodiments of this disclosure, particularly those describing the formation of shorter, more rounded ice balls, can be applied to anatomical locations such as the medial cervical branch nerves, medial thoracic branch nerves, and intercostal nerves. Embodiments of this disclosure, particularly those describing the formation of elongated ice balls, can be applied to anatomical locations such as the greater and lesser occipital nerves, sacroiliac joint nerves, gluteal cutaneous nerves, trochanteric bursa, and rectal nerve. A variety of conditions may be treated according to embodiments of this disclosure, but are not limited to, phantom limb pain, postoperative pain management from procedures including total knee arthroplasty, thoracotomy, and mastectomy, Morton's neuroma, chronic migraine, and / or other neurological applications, rib fractures, diabetic neuropathy, PENG block (pericuspal nerves, hip joint), spasticity, applications related to advanced acupuncture techniques (e.g., cryo-auricular therapy), and sports injuries (e.g., ankle sprains). Additional neurological / indications that may be treated according to embodiments of the present disclosure include the pudendal nerve for the treatment of pudendal neuralgia causing pelvic pain, the celiac plexus for the treatment of upper abdominal pain including pancreatitis, liver cancer, and stomach cancer, the hypogastric plexus for the treatment of lower abdominal and pelvic nerves for further treatment of chronic pelvic pain (e.g., pain originating from the colon, bladder, lower intestine, uterus, ovaries, prostate, etc.), and the stellate ganglion for the treatment of pain in the head, neck, chest, or arm caused by conditions such as reflex sympathetic dystrophy, nerve injury, and herpes zoster. Embodiments of the present disclosure may be used to further treat arrhythmias. Further embodiments of the present disclosure may be used to treat post-traumatic stress disorder (PTSD).

[0035]

[0046] In at least some embodiments, the needle 115 includes a conductive surface for performing nerve stimulation and determining its location in patient tissue proximal to the target tissue. The needle 115, e.g., a needle probe 110, may be coupled to a percutaneous peripheral nerve stimulation (PENS) device (not shown) for performing nerve stimulation. According to at least some embodiments, the needle 115 does not include any type of dielectric (e.g., insulating) coating. In other embodiments, a dielectric coating may be applied to at least a portion of the needle 115. In yet another embodiment, a dielectric coating may be applied around the entire circumference of the needle 115, except for a portion of the needle 115 that forms the exposed portion of the needle 115.

[0036]

[0047] According to several embodiments, the needle 115 comprises a silica tube (e.g., a silica tube 314 as shown in Figure 3). In particular, the needle may contain silica having an inner diameter (ID) of 65 μm × an outer diameter (OD) of 135 μm. The ratio of the inner diameter to the outer diameter of the needle (ID / OD) may be between 0.756 and 0.85. In various embodiments, the needle includes a thin wall to facilitate passage through curved sections while remaining sealable by welding at its distal end. Minimal stainless steel material may be used to weld the distal end to ensure flexibility while maintaining a leak-proof seal. The silica may be processed by precision cutting to form a lumen that provides a flow path for supplying cryogenic agent to the distal end of the needle 115. The ID selection of the silica size results in the formation of a suitable ice ball, and the OD is minimized to improve the available discharge space within the needle 115. For example, blockage within the needle 115 is reduced. In particular, the valve opening time may be extended, and the ice ball is formed along the distal portion of the introducer. In at least some embodiments, the needle 115 may be formed from minimal material to enhance the flexibility of the needle 115 for mating with a straight or curved tip introducer, by optimizing the use of blunt-tip needle material and welding method, as will be described in more detail below. In exemplary embodiments, the needle 115 is flexible enough to be introduced into target tissue via a straight or curved introducer, as will be described in more detail below. The needle 115 may be removed from the introducer and used at different treatment sites with a new introducer, thereby reducing the overall treatment time. In particular, in systems with only a cooling needle (e.g., without an introducer), an ice ball forms, and the medical professional must wait for the ice ball to melt before proceeding to the next treatment site. Beneficially, the needle described herein may be removed from the introducer to which the ice ball is attached, and the needle may be used to form a second ice ball while the first ice ball is melting. Advantageously, a long needle with a silica tube having an appropriate ratio between its inner and outer diameters forms an ice ball for its intended application.

[0037]

[0048] In various embodiments, the cryogenic device 100 further includes a needle guard 150, which is a safety mechanism that covers the needle 115 when the cryogenic device 100 is not in use. Furthermore, the needle 115 may be connectable to a nerve stimulator (not shown) via a cable of the nerve stimulator. The needle guard 150 provides further protection to the needle 115 and can accommodate the needle probe 110 and the needle 115 when the cable of the nerve stimulator is connected to the needle probe 110, which will be described in more detail below. In various embodiments, the needle guard 150 may be transparent or opaque.

[0038]

[0049] Figure 2A shows the needle probe 110 detached from the probe receptacle 170 in Figure 1, and Figure 2B shows the needle probe 110 coupled to the probe receptacle 170 in Figure 1. The needle guard 150 may be detachably coupled to the needle probe 110 so that the needle guard 150 and the needle probe 110 are removed together from the probe receptacle 170 as a single unit. In various embodiments, the needle guard 150 may be further detached from the needle probe 110, and the needle probe 110 may be removed separately from the probe receptacle 170. Advantageously, the needle probe 110 is configured to be removed from the probe receptacle 170 coupled or uncoupled with the needle guard 150 provided herein, depending on the preference of the healthcare professional, the stage of the procedure, etc.

[0039]

[0050] Figure 3 is an exploded view of the needle probe 110. The needle probe 110 supports a needle 115 containing a silica tube 314 and is coupled to the needle 115. The needle 115 is covered by a needle guard 150 and may be removably coupled to the needle guard 150. As shown in Figure 3, the needle guard 150 may include a slotted mechanism 302 for receiving a connector 304 on the needle probe 110 into which a cable of a nerve stimulator (not shown) is inserted or otherwise coupled. According to various embodiments, the slotted mechanism 302 is sized and shaped such that the cable can be coupled to the connector 304 while the needle guard 150 is coupled to the needle probe 110. Thus, there is no interference between the needle guard 150 and the cable while the cable is coupled to the connector 304. Advantageously, the needle guard 150 securely houses the needle probe 110 and needle 115 and maintains an electrical connection with the nerve stimulator for long treatment times (e.g., 10 minutes, 15 minutes, 20 minutes, etc.). Therefore, healthcare professionals can act safely during the procedure without needing to disconnect or reconnect the electrical connection. Furthermore, healthcare professionals can engage and disengage the needle guard 150 while maintaining the electrical connection to the PENS.

[0040]

[0051] According to various embodiments, the needle guard 150 further protects the shape of the needle 115 (e.g., either straight or curved) during use (e.g., between treatment cycles) and storage. For example, the needle guard 150 reduces the occurrence of undesirable bending of the needle 115, such as during transport or storage, thereby ensuring that the needle 115 remains usable until and during the procedure. The needle guard 150 further provides sanitary cover for the needle 115 when it is not inserted into the patient's skin or the like. For example, the needle guard 150 prevents the needle 115 from coming into contact with contaminated or other unsanitary surfaces during treatment cycles and / or before the start of the procedure.

[0041]

[0052] According to various embodiments, the needle guard 150 may further include a coupling mechanism 306 positioned on the inner and outer surfaces of the needle guard 150 to retain the needle probe 110 within the needle guard 150 when the needle guard 150 is coupled to the needle probe 110. As shown in Figure 3, the coupling mechanism 306 may include a bullseye as an indicator for the user to apply pressure. A corresponding retaining element (not shown) within the needle guard 150 may be pushed into a corresponding recess 308 on the needle probe 110 (for example, coupled to each other) so that the needle guard 150 grips the needle probe 110 and the needle guard 150 and needle probe 110 can be removed together. In various embodiments, if no pressure is applied to the coupling mechanism 306, the needle guard 150 may be removed from the needle probe 110 without the needle probe 110 being removed from the probe receptacle 170.

[0042]

[0053] According to some embodiments, the needle probe 110 may include a housing 310. According to various embodiments, the housing 310 may be a two-part housing or a integrally formed housing. A heater block 312 is located within the housing 310. The heater block 312 may be used to warm the skin during treatment to reduce the occurrence of cryogenic burns, particularly when used with relatively short needles. In some embodiments, the heater block 312 may be further used to hold and heat the needle 115 and / or the cooling fluid. In particular, the heater block 312 may be used to hold the needle 115 straight relative to the axis of the cryogenic device 100. The heater block 312 may be designed to have sufficient clearance for the adhesive to hold the heater block 312 in place within the housing 310.

[0043]

[0054] In some embodiments, it may be preferable to limit the frozen tissue that is not at a therapeutic temperature, i.e., to limit the size of the ice balls (e.g., cryozones) formed within the tissue. Such ice balls may be associated with a specific physical reaction, such as the formation of an ice ball, or with a specific temperature profile or temperature-volume gradient required to have a therapeutic effect on the tissue within it. To achieve this, a large temperature gradient can be maintained at its outer edge by metering the coolant flow. This may be particularly advantageous in applications where an array of connected ice balls (i.e., fences) is created within the therapeutic zone, as this provides time for the therapeutic zone to fully unfold within the fenced portion of the tissue, while a relatively large temperature gradient is maintained at the outer boundary due to the repeated application and removal of the cooling force. This provides a mechanism within the tissue to thermally regulate the therapeutic zone, increasing the ability to regulate the therapeutic zone at a given distance from the skin surface. The associated therapeutic algorithm may be predefined or may respond to feedback from the tissue. Various embodiments of this disclosure may be implemented by a printed circuit board assembly (PCBA) 316 and its components, and / or connected thereto, such as the processor 122 described with respect to Figure 1.

[0044]

[0055] Figure 4 shows an exemplary ice ball formed by the needle probe of Figure 1. In particular, Figure 4 shows an ice ball 402 having a teardrop shape formed on the distal tip 404 of the needle 115 and on the distal portion 406 of the introducer 408, as will be described in more detail below. The teardrop contains a larger volume toward the distal tip 404 of the needle 115 compared to the proximal end of the ice ball 402. Such an ice ball is uniquely suited to treating the various symptoms described herein. According to an exemplary embodiment, the ice ball 402 may have a length (along the introducer 408) of length A 15.5 ± 5 mm and its widest width (along the axis perpendicular to the introducer 408) of width B 7.5 ± 5 mm.

[0045]

[0056] Figure 5 shows the needle guard 150 and needle probe 110 of Figure 1. As is more clearly shown in Figure 5, the needle guard 150 includes a coupling mechanism 306 positioned on the inner and outer surfaces of the needle guard 150 to retain the needle probe 110 within the needle guard 150 when the needle guard 150 is coupled to the needle probe 110. As shown in Figure 3, the coupling mechanism 306 may advantageously include a bullseye as an indicator for the user to apply pressure. In other embodiments, the coupling mechanism 306 may be indicated by a different shape and / or color. As further shown in Figure 5, the needle guard 150 may include a gripping mechanism 502 (e.g., a chevron) for aligning the needle guard 150 over the needle probe 110 and indicating the direction for removing the needle guard 150 and / or the needle probe 110 from the probe receptacle. The gripping mechanism 502 allows for the removal of the needle guard 150 from the needle probe 110 while the needle probe 110 remains coupled to the probe receptacle and cryogenic device.

[0046]

[0057] Figure 6 shows a perspective view of the needle guard 150 of Figure 1. From this figure, the retaining arm 602 of the coupling mechanism 306 of the needle guard 150 is visible. As will be understood by those skilled in the art, the coupling mechanism 306 is aligned with the retaining arm 602. Pressure applied to the coupling mechanism 306 pushes the retaining arm 602 inward, and if a needle probe 110 is present, the retaining arm 602 is inserted into the corresponding recess 308 to grip the needle probe 110 within the needle guard 150. Thus, the needle guard 150 may be detachably coupled to the needle probe 110, and both the needle guard 150 and the needle probe 110 may be detachable from the probe receptacle. According to various embodiments, a pair of coupling mechanisms 306 may be located on both sides of the outside of the needle guard 150, and the corresponding retaining arms 602 may be located on both sides of the inside of the needle guard 150, but one or more sets of coupling mechanisms 306 and retaining arms 602 may be provided.

[0047]

[0058] Figure 7A shows an external view of the access cover 700 of the cryogenic device 100, and Figure 7B shows an internal view of the access cover 700 of the cryogenic device 100. The access cover 700 may be a semi-permanent USB port cover that secures itself by utilizing the internal mechanism of the port. Access to the internal ports of the cryogenic device represents a potential electrical safety risk. The addition of the access cover 700 reduces unintentional access to the port(s) and may require a tool to remove the access cover 700. The access cover 700 provides further electrical isolation from the inside of the cryogenic device 100. The access cover 700 may include materials such as Makroblend EL700, PC, PET, and other similar plastic blends. These materials reliably prevent access to the port while providing high dielectric strength, flame resistance, chemical resistance, and impact resistance for the cryogenic device design.

[0048]

[0059] According to various embodiments, the access cover 700 may be removed using a dedicated tool to enhance cybersecurity and electrical safety. In various embodiments, the access cover 700 includes a retaining mechanism 702 on its inner surface 704, as shown in Figure 7B. The retaining mechanism 702 may be secured to the cryogenic device by press-fit interference. Furthermore, the access cover 700 may include a reset button through-hole 706 (or a partial through-hole 706 as shown in Figures 7A and 7B) and another cutout slot 708 on its upper surface. The reset button through-hole 706 allows access to a manual reset button on the cryogenic device without compromising the design intent of ensuring access to the USB port without the use of a tool. In various embodiments, the surface profile of the access cover 700 is sized and shaped such that the access cover 700 sits substantially flush with the cryogenic device 100. The access cover 700 substantially prevents unintentional access to the USB port without the use of a removal tool.

[0049]

[0060] The access cover 700 can be manufactured using a variety of materials, which are based at least in part on their applicability to many risk mitigation measures related to electrical safety, as well as on cybersecurity risks, considering port access prevention to deter physical connections and / or hacking attempts. To provide specific electrical and / or mechanical properties, dielectric coatings for electrical insulation, or mechanically based coatings such as bead blasting or polishing, can be added to or otherwise transferred to the access cover 700. The access cover 700 may include various elements such as oversizing, the addition of screw attachments, a latching mechanism to hold the access cover 700 in place, a mechanical pin expansion locking mechanism, and concealing the access cover 700 so that prior knowledge is required to access the port. The access cover 700 can be applied to any type of I / O port known in the art, including USB ports, micro USB, mini USB, USB-C, Apple Lightning Port, Thunderbolt, etc.

[0050]

[0061] Various embodiments of this disclosure provide needles and workflows for providing cryotherapy as an alternative to RF ablation for low back pain (LBP) originating from the lumbar facet joints, including medial branch nerves (e.g., peripheral spinal nerves). Further applications include the treatment of vertebral nerves (BVN), SI joints, sciatic nerve, radiculopathy, nerve compression syndrome, herniated disc, neuropathy, spinal stenosis, degenerative disc disease, spondylolisthesis, degenerative arthritis of the spine, spasticity, and any other applications and / or applications to any other spine including any other applications described herein and / or treatment zones. As stated above, the needles described herein may be blunt needles having a length of 175 mm or more. The needles may be uniquely applicable to access deep nerves and form an ice ball (e.g., a cooling zone) to an appropriate depth for treating the aforementioned symptoms. Furthermore, embodiments of this disclosure achieve improved cryogenic agent delivery efficiency, reduced treatment cycle time, and compatibility with commercially available introducers.

[0051]

[0062] Figure 8 shows an exemplary needle system for administering cryotherapy to target tissue. The needle includes a single, long, blunt needle having electroneurostimulatory capabilities to assist in precise nerve localization, such as the needle 115 described herein. In various embodiments, the needle is at least 25G. According to various embodiments of this disclosure, an introducer 800 is provided for inserting the needle 115 into the patient's target tissue. According to various embodiments, the introducer 800 may have a gauge of 15G to 20G. The introducer 800 may be a radio frequency (RF) introducer that provides a pathway for the needle 115 from the patient's skin 802 to the patient's target tissue 804 in order to form an ice ball 806 along at least a portion of the distal end 810 of the introducer 800 at the distal tip 808 of the needle 115. For example, the introducer 800 may be an introducer with a sharp tip configured to puncture the patient's skin 802. In various embodiments, the introducer 800 advantageously provides electrical insulation to the needle 115 so that there is no need to add an electrical insulating coating to the needle 115. Therefore, the needle 115 does not need to include an insulating dielectric coating or the like.

[0052]

[0063] According to some embodiments, the needle 115 maintains close contact with the introducer 800 to minimize the thermal insulation effect.

[0053]

[0064] According to at least some embodiments, the introducer 800 may be a 20G cannula (e.g., an introducer needle). The introducer 800 may include a curved or straight tip. For example, in some embodiments, the introducer 800 may include a 10 mm curved tip. In further embodiments, the introducer 800 may be coupled to a ready-made (OTS)PENS. According to various embodiments, the position and placement of the introducer 800 may be confirmed by means of fluoroscopy, ultrasound, or any standard care imaging technique, or by using a nerve stimulator, etc., in a manner known in the art.

[0054]

[0065] As shown in Figure 8, the ice ball 806 may be formed at the distal tip 808 of the needle along at least a portion of the distal end 810 of the introducer 800. According to an exemplary embodiment, the ice ball 806 may have a length of 16.6 mm (along the introducer 800) and a width of 7.5 mm (along an axis perpendicular to the introducer 800). According to at least some embodiments, the center of the ice ball 806 may be formed at least 3.0 mm proximal to the distal tip 808 of the needle 115. According to some embodiments, the ice ball 806 may form a teardrop shape, but the ice ball 806 may have a more rounded appearance depending on the insertion depth of the introducer 800 and / or the velocity of the cryogenic fluid flow toward the distal tip 808 of the needle 115. For example, a relatively fast flow velocity will form a longer ice ball 806 compared to a relatively slow flow velocity. The longer Ice Ball 806 may be preferable for a variety of applications, such as when the target tissue includes the SI joint and associated nerves.

[0055]

[0066] Figure 9 is a flowchart of a method for treating low back pain experienced by a patient. Although Method 900 is described primarily in relation to the treatment of low back pain, Method 900 and the system described herein may be applied to a variety of applications, including the treatment of BVN, SI joint, sciatica, radiculopathy, nerve compression syndrome, herniated disc, neuropathy, spinal stenosis, degenerative disc disease, spondylolisthesis, osteoarthritis of the spine, spasticity, etc., including any other applications and / or treatment zones described herein. Method 900 includes a method for treating low back pain experienced by a patient using a cryogenic device including at least some of the embodiments described herein. For example, the cryogenic device may include a needle probe having at least one needle, the at least one needle having a proximal end, a distal end, and a needle lumen between them. The needle may be configured to be inserted in close proximity to the location of a target tissue associated with low back pain (or any other application described herein). The needle may further include a cooling fluid supply lumen that extends distally within the needle lumen to the distal portion of the needle lumen, and a cooling fluid source that can be coupled to the cooling fluid supply lumen to guide a cooling fluid flow into the needle lumen.

[0056]

[0067] Method 900 further includes step 902, which includes identifying the location of the treatment zone by reference to a skin surface adjacent to the target tissue associated with the lower back pain. In various embodiments, the nerve and / or target tissue may include any of the BVN, medial branch nerves, or nerves described herein. According to various embodiments described herein, the target nerve may be pre-located using a PENS device and / or anatomical landmarks, or otherwise the target nerve may be located in general. In yet another embodiment, fluoroscopy may be used in addition to other imaging techniques such as ultrasound. In some embodiments, determining the location of treatment is performed using nerve stimulation by stimulating the nerve with the conductive surface of at least one needle.

[0057]

[0068] Step 904 includes inserting at least one needle of the cryogenic device through the skin surface via the introducer to a first location in the treatment zone. Step 904 may include positioning the introducer (e.g., a cannula) to create an access site in the tissue, where the introducer defines a tubular member having a lumen and extending between the proximal and distal ends of the introducer. The tissue may include the vertebral tissue beneath the patient's skin surface and the proximal branch nerves of the vertebrae. Inserting at least one needle of the cryogenic device probe assembly through the skin via the introducer may include inserting at least one needle until the proximal end of at least one needle is coplanar with the proximal end of the introducer. For example, at least one needle may be advanced distally through the lumen of the introducer to position the distal tip of at least one needle adjacent to the nerve. Step 904 may include performing percutaneous nerve localization (e.g., using PENS) to determine whether the needle and / or introducer is proximal to the target nerve. If nerve localization using percutaneous nerve stimulation fails, the needle and / or introducer may be repositioned in the tissue. Percutaneous nerve localization may then be performed again to determine whether the repositioning has correctly positioned the needle and / or introducer sufficiently proximal to the target nerve.

[0058]

[0069] Step 906 includes activating the cryogenic device to generate a desired ice ball in close proximity of at least one needle to the target tissue, thereby relieving or reducing the severity of pain. For example, as illustrated and described with respect to Figure 8, a cryotherapy probe may be activated to administer cryotherapy and generate an ice ball around the distal tip of the blunt needle and / or along the distal portion of the introducer. According to at least some embodiments, activating the cryogenic device includes increasing the flow rate of cryogenic agent through the needle. The flow rate may be 925 ± 5 ml / min.

[0059]

[0070] Step 908 further includes removing at least one needle from the introducer at the first location in the treatment zone, leaving the ice ball attached to the distal portion of the introducer at the first location in the treatment zone until the ice ball melts. For example, the introducer may remain in the target tissue, and the ice ball remains attached to the introducer inserted into the skin until the ice ball melts. The cooling time of the ice ball may be between 70 ± 5 seconds and the post-cooling time may be between 15 ± 5 seconds, such that the total treatment time for each location in the target tissue is between 86 ± 5 seconds. Thus, while the ice ball melts at the first location, the healthcare professional may, if necessary, restart the process at a second location using a blunt-tipped needle and another introducer. This continuous process helps to reduce the overall treatment time by reducing the downtime between treatments at multiple locations. Embodiments of the present disclosure enable a reduction of up to 20% in treatment time compared to other treatment options.

[0060]

[0071] Method 900 may include removing the introducer from the treatment zone after a predetermined time and inserting at least one needle of the cryogenic device probe assembly through the skin via the introducer into a second or subsequent location in the treatment zone. The cryogenic device may be operated so that at least one needle generates a second or subsequent ice ball around a nerve, thereby relieving or reducing the severity of pain. Thus, at least one needle may be removed again from the introducer (the same or a different introducer) and the treatment zone after treatment. The ice ball remains attached to the introducer inserted into the skin until the second or subsequent ice ball melts.

[0061]

[0072] The ratio between the inner and outer diameters of the needle described herein allows the ice ball to remain attached to the distal portion of the introducer when the needle is removed, so that the ice ball can remain inside the patient's body when treating different locations within the target tissue. The inner and outer diameters may be increased or decreased (while maintaining the ratio between them) to change the size of the ice ball depending on the intended application. If the ratio between the inner and outer diameters of the silica tube 314 providing the cryogenic fluid pathway is not properly adjusted, the ice ball may form an abnormal or unexpected shape that is not useful for treating nerves in the target tissue. For example, the ice ball may be asymmetrical or otherwise irregular in shape.

[0062]

[0073] Figure 10 is an anatomical diagram illustrating exemplary target tissues and treatment locations. As can be understood by referring to Figure 10, the needle 115 can be thermally coupled to the target nerve 1002, in this case the medial branch nerve, by positioning the needle 115 near the spinal cord adjacent to the epidural space, a branch nerve from the vertebral column within or adjacent to the vertebral foramen of a herniated disc, or another target nerve tissue and / or vertebral tissue. Verification of positioning may be provided using an electromyography system (EMG) as described above, and / or positioning may be optionally guided using fluoroscopy, ultrasound imaging, and / or other imaging modalities. Treatment may be applied according to various embodiments described herein, including at least the embodiment described with respect to method 900 in Figure 9.

[0063]

[0074] Figure 11 is an anatomical diagram showing exemplary target tissue and treatment location. Similarly, as shown in Figure 10, the needle 115 can be thermally bonded to the target nerve 1102, in this case the BVN, by positioning it between the intervertebral discs and / or endplates of the vertebrae of the spine.

[0064]

[0075] One or more computing devices may be adapted to provide desired functionality by accessing software instructions rendered in a computer-readable format. Where the software is used, the teachings contained herein may be implemented using any suitable programming language, scripting language, or other type of language or combination of languages. However, the software does not need to be used exclusively, or may not be used at all. For example, some embodiments of the methods and systems described herein may also be implemented by hardwired logic or other circuit configurations, including, but not limited to, application-specific integrated circuits or field-programmable gate arrays. Combinations of computer execution software with hardwired logic or other circuit configurations may also be preferred.

[0065]

[0076] Embodiments of the methods disclosed herein may be carried out by one or more suitable computing devices. Such a system may comprise one or more computing devices adapted to carry out one or more embodiments of the methods disclosed herein. As described above, such a device may have access to one or more computer-readable media that, when run by at least one computer, embody computer-readable instructions causing at least one computer to carry out one or more embodiments of the methods of the subject. Additionally or alternatively, the computing device may comprise a circuit configuration that enables the device to operate to carry out one or more of the methods of the subject.

[0066]

[0077] Any suitable computer-readable medium or more computer-readable media may be used to implement or practice the subject matter now disclosed, including, but not limited to, drives and other magnetic-based storage media, optical storage media including disks (e.g., CD-ROMs, DVD-ROMs, and variations thereof), flash memory, RAM, ROM, and other memory devices.

[0067]

[0078] As used in this patent, the terms “invention,” “the invention,” “this invention,” and “the present invention” are intended to broadly refer to all of the subject matter of this patent and the following claims. Any statements containing these terms should be understood not to limit the subject matter described herein, nor to limit the meaning or scope of the following claims.

[0068]

[0079] While the subject matter of embodiments of the present invention is described herein in detail, this description is not necessarily intended to limit the scope of the claims. The claimed subject matter may be embodied in other ways, may include different elements or steps, and may be used in conjunction with other existing or future technologies. This description should not be construed as implying any particular order or arrangement among or between the various steps or elements unless the order of arrangement of the individual steps or elements is explicitly stated.

[0069]

[0080] Different arrangements of the components shown in the drawings or described above, as well as components and steps not shown or described, are possible. Similarly, several features and subcombinations are useful and can be adopted without reference to other features and subcombinations. Embodiments of the present invention are described for illustrative purposes only and not for limitation, and alternative embodiments will be apparent to the reader of this patent. Thus, the present invention is not limited to the embodiments described above or shown in the drawings, and various embodiments and modifications can be made without departing from the scope of the following claims.

Claims

1. A cryogenic device for treating a patient's target tissue, wherein the device is A handpiece having a size and shape suitable for support by an operator's hand, and having at least one cooling fluid supply path disposed within the handpiece, The handpiece comprises a needle probe coupled to the distal portion of the handpiece, and the needle probe is The probe body and A blunt needle coupled to the probe body, wherein the blunt needle comprises a proximal end, a distal end, and a needle lumen between the proximal end and the distal end, The system comprises a silica supply tube extending within the needle lumen and coupled to the at least one cooling fluid supply path, wherein the silica supply tube has an inner diameter and an outer diameter, and the ratio of the inner diameter to the outer diameter of the silica supply tube is configured to provide a desired ice ball shape. Cryogenic device.

2. The cryogenic apparatus according to claim 1, wherein the desired ice ball shape is teardrop-shaped.

3. The cryogenic apparatus according to claim 1, wherein the ratio of the inner diameter to the outer diameter of the silica supply pipe is 0.756 to 0.

85.

4. The cryogenic apparatus according to claim 1, wherein the flow rate of the cooling fluid is further configured to provide the desired ice ball shape at the distal end of the blunt needle.

5. The cryogenic apparatus according to claim 1, wherein the gauge of the blunt needle is 25G or greater.

6. The cryogenic apparatus according to claim 1, wherein the blunt needle has a length of 175 mm or more.

7. The cryogenic apparatus according to claim 1, wherein the target tissue includes medial branch nerves.

8. The cryogenic apparatus according to claim 1, wherein the target tissue includes the sacroiliac joint.

9. The cryogenic apparatus according to claim 1, wherein the target tissue includes vertebral nerves.

10. The cryogenic apparatus according to claim 1, wherein at least a portion of the blunt needle is conductive for performing nerve stimulation and identifying the target tissue.

11. The cryogenic apparatus according to claim 1, wherein the blunt needle does not contain a dielectric coating.

12. The cryogenic apparatus according to claim 1, further comprising a needle guard configured to accommodate the needle probe.

13. The cryogenic apparatus according to claim 1, further comprising an access cover configured to seal the internal ports of the cryogenic apparatus.

14. A cryogenic device for treating a patient's target tissue, wherein the device is A handpiece having a size and shape suitable for support by an operator's hand, and having at least one cooling fluid supply path disposed within the handpiece, The handpiece comprises a needle probe coupled to the distal portion of the handpiece, and the needle probe is The probe body and A blunt needle attached to the probe body, wherein the blunt needle has a proximal end, a distal end, and a needle lumen between the proximal end and the distal end, and the blunt needle has a length of 175 mm or more and a gauge of 25 G or more, The system comprises a silica supply tube extending within the needle lumen and coupled to the at least one cooling fluid supply path, wherein the silica supply tube has an inner diameter and an outer diameter, and the ratio of the inner diameter to the outer diameter of the silica supply tube is configured to provide a desired teardrop-shaped ice ball. Cryogenic device.

15. A cryogenic system for relieving a patient's lower back pain, wherein the system is A handpiece having a size and shape suitable for being supported by an operator's hand, and having at least one cooling fluid supply path disposed within the handpiece, and The handpiece is equipped with a needle probe attached to its distal portion, and the needle probe is Probe body, At least one needle coupled to the probe body, wherein the at least one needle comprises a proximal end, a distal end, and a needle lumen between the proximal end and the distal end, and The device comprises a silica supply tube extending within the needle lumen and connected to the at least one cooling fluid supply path, Cryogenic equipment and The cryogenic device comprises an introducer configured to receive the at least one needle and to position the at least one needle in close proximity to the location of a target tissue associated with lower back pain, wherein the cryogenic device is configured to provide a desired ice ball shape that remains on the distal portion of the introducer after the at least one needle has been removed from the introducer. Cryogenic systems.

16. The system according to claim 15, further comprising a needle guard configured to accommodate the needle probe.

17. The system according to claim 16, wherein the needle guard comprises a gripping mechanism configured to removably connect the needle guard to the needle probe.

18. The system according to claim 16, wherein the needle guard comprises a coupling mechanism configured to detachably connect both the needle guard and the needle probe from the handpiece.

19. The system according to claim 18, wherein the coupling mechanism is arranged on the inner and outer surfaces of the needle guard.

20. The system according to claim 16, further comprising a nerve stimulator configured to be electrically coupled to the probe body of the needle probe, wherein the needle guard is configured to accommodate the at least one needle when the cable of the nerve stimulator is coupled to the probe body.

21. The system according to claim 20, further comprising a slotted mechanism on the needle guard for receiving a connector for the cable of the nerve stimulator.

22. The system according to claim 15, wherein the introducer is configured to minimize the post-cooling time by the cryogenic device by allowing the ice ball to melt while remaining on the introducer.

23. The system according to claim 15, wherein the target tissue includes a medial branch nerve.

24. The system according to claim 15, wherein the target tissue includes vertebral nerves.

25. The system according to claim 15, wherein the target tissue includes the sacroiliac joint.

26. The system according to claim 15, further comprising an access cover configured to prevent access to the internal ports of the cryogenic handpiece.

27. The system according to claim 15, wherein the gauge of at least one needle is within the range of 25G or more, and the length of at least one needle is 175 mm or more.

28. A method for treating a patient's lower back pain, wherein the method is A handpiece having a size and shape suitable for being supported by an operator's hand, and having at least one cooling fluid supply path disposed within the handpiece, and The handpiece is equipped with a needle probe attached to its distal portion, and the needle probe is Probe body, At least one needle coupled to the probe body, wherein the at least one needle comprises a proximal end, a distal end, and a needle lumen between the proximal end and the distal end, and A silica supply tube extending within the needle lumen and connected to the at least one cooling fluid supply path, wherein the silica supply tube has an inner diameter and an outer diameter, and the ratio of the inner diameter to the outer diameter of the silica supply tube is configured to provide a desired ice ball shape. To provide cryogenic equipment, Identifying the location of the treatment zone by referring to the skin surface adjacent to the nerves associated with lower back pain, Inserting at least one needle of the cryogenic device through the introducer through the skin surface to the first location of the treatment zone, The cryogenic device is operated such that at least one needle generates a desired ice ball shape around the nerve, thereby relieving or reducing the severity of the lower back pain. The procedure involves removing the at least one needle from the introducer at the first position in the treatment zone while the ice ball remains attached to the distal portion of the introducer at the first position in the treatment zone until the ice ball melts. Methods that include...

29. The method according to claim 28, further comprising inserting the introducer through the skin surface to the first position in the treatment zone before inserting the at least one needle of the cryogenic device through the introducer through the skin surface to the first position in the treatment zone.

30. The introducer is removed from the treatment zone after a predetermined time, Inserting at least one needle of the cryogenic device through the skin via the introducer into the second location of the treatment zone, The cryogenic device is operated such that at least one needle generates a second ice ball around the nerve, thereby eliminating or reducing the severity of the lower back pain. With the second ice ball still attached to the distal portion of the introducer at the second location in the treatment zone, the at least one needle is removed from the introducer at the second location in the treatment zone. The method according to claim 28, further comprising:

31. The method according to claim 28, wherein determining the location of treatment is performed by nerve stimulation by stimulating a nerve with the conductive surface of the at least one needle.

32. The method according to claim 28, wherein inserting the at least one needle of the cryogenic apparatus through the skin via the introducer includes inserting the at least one needle until the proximal end of the at least one needle is coplanar with the proximal end of the introducer.

33. The method according to claim 28, wherein the nerve includes a vertebral nerve.

34. The method according to claim 28, wherein the target tissue includes a medial branch nerve.

35. The method according to claim 28, wherein the target tissue includes the sacroiliac joint.

36. The method according to claim 28, wherein the introducer is configured to minimize the post-cooling time by the cryogenic device by allowing the ice ball to melt while remaining on the introducer.

37. The method according to claim 31, wherein the cryogenic device further comprises a needle guard for housing the at least one needle, the needle guard comprising a slotted mechanism on the needle guard for receiving a connector for a cord of a nerve stimulator, such that the cord remains coupled to the probe body for the duration of the treatment.

38. The method according to claim 37, further comprising pressing down the coupling mechanism on the needle guard to simultaneously remove both the probe body and the needle guard from the handpiece.

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