Cryogenic surgical instrument with right-angle end effector

Abstract

This specification discloses a cryogenic probe comprising a handle and a shaft having a proximal end coupled to the handle, the shaft defining a longitudinal axis, and an end effector coupled to the distal end of the shaft, the end effector comprising a first prong, a second prong, and a curved portion between the first and second prongs, the first and second prongs configured to receive cryogenic fluid, the first and second prongs extending perpendicular to the longitudinal axis and spaced apart along the longitudinal axis, and a supply conduit configured to supply cryogenic fluid to the end effector.

Description

Technical Field

[0001] Cross - reference to Related Applications This application is a non - provisional application of U.S. Provisional Application No. 63 / 508,676, filed on June 16, 2023, U.S. Provisional Application No. 63 / 508,683, filed on June 16, 2023, and U.S. Provisional Application No. 63 / 562,885, filed on March 8, 2024. U.S. Provisional Application No. 63 / 508,676, U.S. Provisional Application No. 63 / 508,683, and U.S. Provisional Application No. 63 / 562,885 are hereby incorporated by reference in their entirety into this specification.

[0002] The present disclosure relates to cryosurgery devices, and more particularly, to cryosurgery instruments having a cryoactive zone and related methods.

Background Art

[0003] Below - knee amputation (BKA) is defined as any amputation at a position above the ankle and below the knee. Currently, there are no widely implemented non - pharmacological pain relief methods and pain relief devices for amputee patients. This is, in part, because the nerves in the leg have different sizes and are located at different positions, and it is difficult for current devices to promote freezing of all potential nerves in the leg. Phantom limb pain (PLP) is the perception of pain originating from the amputated limb. BKA affects approximately 60% of amputee patients, while PLP affects approximately 60 - 85% of amputee patients.

[0004] In the United States, there are approximately 185,000 amputee patients each year. During amputation surgery, pain relief can be achieved by freezing the nerves at or near the amputation site. Surgeons generally freeze the nerves proximally with visualization after nerve transection and leg amputation. However, current devices cannot grip the nerves stably, so the nerves cannot be frozen at the desired position.

Prior Art Documents

Patent Documents

[0005] [Patent Document 1] U.S. Patent No. 11,628,007B2 [Overview of the project] [Problems that the invention aims to solve]

[0006] Therefore, there is a need for methods and devices for pain relief during BKA treatment that feature simple engagement with nerves by direct contact with multiple nerves simultaneously. These devices and methods should be able to freeze various surfaces of nerves without the need for repeated freezing. [Means for solving the problem]

[0007] This specification presents a cryogenic probe comprising a handle and a shaft having a proximal end coupled to the handle, the shaft defining a longitudinal axis, and an end effector coupled to the distal end of the shaft, the end effector comprising a first prong, a second prong, and a curved portion between the first and second prongs, the first and second prongs configured to receive cryogenic fluid, the first and second prongs extending perpendicular to the longitudinal axis and spaced apart along the longitudinal axis, and a supply conduit configured to supply cryogenic fluid to the end effector.

[0008] The cryogenic probe may further comprise a discharge conduit configured to discharge cryogenic fluid from an end effector. The discharge conduit may be arranged concentrically around the supply conduit. The cryogenic probe may further comprise a vacuum insulating layer arranged around the supply conduit. The cryogenic probe may further comprise a tubular thermal barrier element arranged within the vacuum insulating layer. The thermal barrier element may be constructed from at least one of ceramic, glass fiber, elastomer, foam, silicon, carbon fiber, and composite material. The end effector may be inserted into the distal end of the shaft. The end effector may be coupled to the distal end of the shaft via threads. The cryogenic probe may further comprise a nozzle at the distal end of the supply conduit. The nozzle may have an end at a curved portion. The nozzle may have an end proximal to the curved portion. The cross-sections of the first prong and the second prong may be rectangular.

[0009] This specification discloses a method for freezing one or more nerves of a patient, the method including the steps of: advancing a cryogenic probe to a target site, the cryogenic probe comprising a handle, a shaft having a proximal end coupled to the handle, and an end effector coupled to the distal end of the shaft, the end effector comprising a first prong, a second prong, and a curved portion between the first and second prongs, the first and second prongs configured to receive cryogenic fluid, the first and second prongs extending perpendicular to the longitudinal axis of the shaft and spaced apart along the longitudinal axis; positioning the end effector to grasp one or more nerves; supplying cryogenic fluid to the end effector from a supply conduit; and freezing one or more nerves by applying the end effector to the surface of one or more nerves. The method may further include the step of draining the cryogenic fluid from the end effector through a discharge conduit. The nozzle can be located at the distal end of the supply conduit and may have an termination at the curved section. The nozzle may also have an termination at the proximal end of the curved section. [Brief explanation of the drawing]

[0010] [Figure 1A] This figure shows a cryogenic probe according to one modified embodiment of the present invention. [Figure 1B] This is a magnified view of the distal end of the shaft of the cryogenic probe. [Figure 2A] This figure shows an end effector according to one modified form of the present invention. [Figure 2B] This figure shows an end effector according to one modified form of the present invention. [Figure 3A] This figure shows modified forms of cryogenic probes with different nozzle positions. [Figure 3B] This figure shows the modified forms of cryogenic probes with different nozzle positions. [Figure 3C] This figure shows modified forms of cryogenic probes with different nozzle positions. [Figure 4A] This figure shows a modified form of an end effector used with a cryogenic probe. [Figure 4B] This figure shows a modified form of an end effector used with a cryogenic probe. [Figure 4C] This figure shows a modified form of an end effector used with a cryogenic probe. [Figure 4D] This figure shows a modified form of an end effector used with a cryogenic probe. [Figure 4E] This figure shows a modified form of an end effector used with a cryogenic probe. [Figure 4F] This figure shows a modified form of an end effector used with a cryogenic probe. [Figure 4G] This figure shows a modified form of an end effector used with a cryogenic probe. [Modes for carrying out the invention]

[0011] This disclosure intends that cryogenic surgical devices, such as surgical instruments having an active cryogenic zone, can be used in a variety of medical and surgical procedures. Generally, cryogenic surgical instruments can be used to expose a patient's target tissue to cryogenic temperatures. Cryogenic surgical instruments can be used, for example, in cryoablation and / or cryoanesthetics. This disclosure indicates that some cryogenic surgical instruments can be supplied with one or more cryogenic fluids, which can be used to cool active parts such as contact tissue and ablation tips. Some cryogenic surgical instruments can include a supply conduit for transporting cryogenic fluid to an ablation tip and a discharge conduit for transporting used cryogenic fluid from the ablation tip. Some cryogenic surgical instruments can utilize cryogenic fluid supplied under high pressure. For example, some cryogenic surgical instruments using Joule-Thomson expansion at an ablation tip can receive liquid nitrous oxide at up to about 1200 psi and about room temperature and / or discharge nitrous oxide as a gas or gas-liquid mixed phase at about 45 psi and about -90°F. Cryogenic probes and associated conduits and connectors can be designed to withstand such pressures and temperatures. Although below-knee applications are exemplified, aspects of this disclosure can also be applied above-knee and to the upper limbs.

[0012] FIG. 1A shows a cryoprobe 100, which can be part of a cryosurgery system that can include a cryogenic module 108. The cryoprobe 100 can be configured to be operably coupled to the cryogenic module 108, which can supply cryogenic fluid to and / or receive cryogenic fluid from the cryoprobe 100 and can be configured to provide monitoring and / or control functions. Exemplary cryogenic fluids can include one or more of nitrous oxide, argon, carbon dioxide, and / or a phase change fluid (e.g., liquid nitrogen). As used herein, "fluid" can refer to a substance in a liquid phase, a gas phase, a mixture of a liquid phase and a gas phase, and / or a supercritical phase.

[0013] The cryogenic probe 100 may include a handle 104, which may be configured to be grasped by a user and / or engaged by a robotic device (e.g., a surgical robot). More generally, the handle 104 may have any structure that can be configured to fix, hold, and / or manipulate the cryogenic probe 100 to position or restrain it, whether or not it can be utilized by a human (e.g., a surgeon or assistant), a robot, a mechanical device, etc. The handle 104 may be configured to connect to the cryogenic module 108 using one or more connecting elements 106, which may include, for example, one or more fluid conduits (e.g., for supplying and / or discharging cryogenic fluid) and / or one or more conductors (e.g., wiring for thermocouples). The cryogenic probe 100 may include an elongated, generally annular shaft 110, which is generally disposed distally on the handle 104. The distal end 102 of the cryogenic probe 100 may include an end effector (not shown), which may be positioned distally on the shaft 110. The end effector can be used to apply cryogenic pressure, for example, for cryoablation of target tissue 18. The shaft 110 may have a length of approximately 5 inches (approximately 12.7 cm) to approximately 8 inches (approximately 20.32 cm) (for example, approximately 7 inches (17.78 cm)) from the handle 104 to the distal end.

[0014] The shaft 110 may include a first proximal portion 112 and / or a second distal portion 114. In some exemplary embodiments, the proximal portion 112 of the shaft 110 may be generally rigid and / or generally elastically deformable. In this specification, “rigid” can mean a shaft (or part thereof) that does not deform, or deforms minimally, when subjected to forces consistent with the normal intended use of the device. For example, the proximal portion 112 in the embodiment shown in Figure 1A may be configured to maintain a generally linear shape and / or return to such a shape.

[0015] The distal portion 114 of the shaft 110 can be bendable as one or more curves and / or one or more planes. As used herein, "bendable" can refer to a shaft (or a portion thereof) that is elastically deformable and / or plastically deformable when bent under a force consistent with the normal intended use of the device. For example, a bendable shaft (or a portion thereof) may be ductile and / or malleable. As used herein, "ductile" can refer to a shaft (or a portion thereof) that substantially elastically deforms and / or returns to its original shape when the applied stress is lost when subjected to a force consistent with the normal intended use of the device. As used herein, "malleable" can refer to a shaft (or a portion thereof) that can be bent into a desired configuration and substantially remains in that configuration when the applied stress is lost when subjected to a force consistent with the normal intended use of the device. Some exemplary embodiments can be configured to be bent by hand (e.g., without tools). Some exemplary embodiments can be configured to be bent using one or more tools such as a manual handheld tubing bender tool.

[0016] The distal portion 114 and / or the proximal portion 112 of the shaft 110 can be configured to be stiffer than corresponding portions of similar devices. Thus, such embodiments according to at least some aspects of the present disclosure can be utilized at more extreme angles associated with complex surgeries and / or at more different entry angles compared to similar devices.

[0017] The distal portion 114 of the shaft 110 can be configured to bend at an angle with respect to the longitudinal axis A of the shaft 110 and / or the proximal portion 112 of the shaft 110. For example, the distal portion 114 of the shaft 110 may be bendable to about 180 degrees. The distal portion of the shaft 110 may be bendable in any plane that is generally parallel to the longitudinal axis A. In some embodiments, the distal portion 114 of the shaft 114 may be bendable in multiple planes. For example, the distal portion 114 of the shaft 110 may be bendable in both a plane that is generally parallel to the longitudinal axis A of the shaft 110 and a plane that is positioned obliquely (for example, generally to the left) with respect to the longitudinal axis A of the shaft 110. In this specification, “obliquely” may refer to an angle that is neither perpendicular nor parallel. In some such embodiments, the distal portion 114 of the shaft can be bent in a plane generally perpendicular to the longitudinal axis A of the shaft 110 and / or inclined with respect to the longitudinal axis A of the shaft 110. In some embodiments, the distal portion 114 of the shaft 110 can be bent as two or more curves in the same plane or in different planes, such as an upward and downward (or leftward and rightward) generally S-shape.

[0018] The exemplary embodiment shown in Figure 1A may include a shaft 110 that includes both a generally rigid portion and a generally flexible portion, but various exemplary alternative embodiments may include a shaft that includes, in any configuration, one or more generally flexible portions only, one or more generally rigid portions only, or any combination of one or more generally flexible portions and / or one or more generally rigid portions. In the illustrated embodiment, the generally rigid portion is generally straight. However, alternative embodiments may include a generally rigid portion that has one or more curves formed on it, such as to the left, to the right, upward, and / or downward as viewed from the user. In the illustrated embodiment, the generally rigid portion is fixed to the handle and is therefore not rotatable relative to the handle 104. However, in exemplary alternative embodiments, the generally rigid portion can be rotatable relative to the handle 104.

[0019] The shaft 110 may include one or more internal conduits (for example, capable of at least partially defining corresponding lumens and / or flow paths). For example, the shaft 110 may include a supply conduit 116 configured to transport cryogenic fluid from the handle 104 to the end effector, a discharge conduit 126 configured to transport used cryogenic fluid from the end effector, and / or one or more wires 132 connected to a thermocouple 134. In the illustrated embodiment, the supply conduit 116 is constructed from stainless steel (e.g., 304 / 304L stainless steel, temper: hard), and the discharge conduit 126 is constructed from stainless steel. However, alternative materials may be used in other embodiments. The thermocouple 134 may be configured to sense the temperature while the device is operating, for example, the temperature of the distal end 102 of the cryogenic probe 100. In the illustrated embodiment, the thermocouple 134 can be positioned closer to the distal end than a similar cryogenic probe and therefore provides better temperature information than other cryogenic probes. In this specification, “used cryogenic fluid” can refer to cryogenic fluid that has excited an end effector (for example, into the discharge conduit 126), regardless of the phase, temperature, or pressure of the fluid, and regardless of whether the fluid can be further cooled.

[0020] The supply conduit 116 can be arranged generally concentrically within the discharge conduit 126. In this specification, “concentric” can refer to components arranged to have a common center point and / or axis (e.g., longitudinal axis A). In the illustrated embodiment, the cryogenic fluid flowing to the end effector flows through the supply conduit 116, and the spent cryogenic fluid flowing from the end effector flows through the annular lumen inside the discharge conduit 126 and outside the supply conduit 116. The supply conduit 116 and / or the discharge conduit 126 can be arranged generally concentrically within other components of the shaft 110. In alternative embodiments, the conduits 116, 126 can be arranged side-by-side (e.g., generally parallel), non-concentrically within each other, and / or non-concentrically within the shaft 110. The discharge conduit 126 may have a discharge conduit end 128 at its distal end.

[0021] The supply conduit 116 may include a nozzle 118 (e.g., an orifice), through which the cryogenic fluid from the supply conduit 116 flows. During operation, the cryogenic fluid supplied from the cryogenic module 108 can flow into the end effector through the supply conduit 116 and nozzle 118, as described below. Generally, the cryogenic fluid exiting the nozzle 118 may be subject to higher pressure upstream of the nozzle and expand under significantly lower pressure downstream of the nozzle 118. In some exemplary embodiments utilizing nitrous oxide as the cryogenic fluid, nitrous oxide can be supplied as a liquid at a temperature of about 27°C and a pressure of about 800 psi, and the nitrous oxide may have a gas phase or a gas-liquid mixed phase at about 45 psi and -68°C. Alternatively, the cryogenic fluid can be supplied as a supercritical fluid. Joule-Thomson expansion continues within the end effector, and the wall 122 is cooled to a degree sufficient for use in cryosurgery (e.g., cryoablation). For example, depending on the cryogenic fluid used and the state of the fluid, the exemplary flow rate of the cryogenic fluid through the nozzle 118 is approximately 15 cm³ per minute. 3 ~100cm 3The flow rate can be set to a range exceeding this limit.

[0022] The shaft 110 may include insulating portions that interpose the conduits 116, 126 and the outer surface 136 of the shaft 110 in the radial direction. In some exemplary embodiments, the shaft 110 may be configured to provide a higher level of insulation than the corresponding portion of a similar device, thus resulting in operational advantages.

[0023] The insulating portion may include a vacuum insulating layer 130 radially outward of the discharge conduit 126. In this specification, “vacuum insulating layer” refers to at least a partially vacuumed volume configured to reduce heat transfer, including near vacuum, partial vacuum, and full vacuum. In the illustrated embodiment, the vacuum insulating layer 130 includes a generally annular vacuumed volume at least partially surrounded by the outer surface 136 of the discharge conduit 126.

[0024] A thermal barrier element 138 can be arranged radially within the vacuum insulating layer 130 between the discharge conduit 126 and the outer surface 136. For example, the thermal barrier element 138 may generally include annular ceramic textile material. In alternative embodiments, the thermal barrier element 138 may include other insulating materials that can withstand both cryogenic and brazing temperatures, such as glass fiber, elastomer, foam, silicon, carbon fiber, and composite materials. In some alternative embodiments without vacuum insulation, or in the illustrated embodiment, if the integrity of the vacuumed volume is compromised, the thermal barrier element 138 may be configured to provide sufficient thermal insulation to allow the device to meet desired performance requirements with respect to shaft temperature.

[0025] The shaft 110 can be wound helically, and by utilizing a substantially straight-walled configuration in the proximal portion 112 and a substantially spiral configuration in the distal portion 114, it can be configured to provide the desired rigidity in the proximal portion 112 and the desired flexibility in the distal portion 114. In this specification, “spiral” refers to an object having a form or shape that includes a wave, which may or may not be spiral, and which can be folded as a curved or meandering winding, rather than being smooth. In particular, in this embodiment, in the proximal portion 112, the supply conduit 116, the discharge conduit 126, and the shell are each formed as substantially straight-walled (e.g., non-spiral) tubes. In the distal portion 114, the discharge conduit 126 is formed as a substantially spiral tube. In the illustrated embodiment, the spiral and / or helical. However, in alternative embodiments, other spirals, such as circumferential waves, may be utilized. In some exemplary embodiments, one or more wires 132 connected to the thermocouple 134 may be routed in a generally helical manner along the distal portion 114 of the shaft 110, such as wrapping around the distal portion 114 in a generally helical groove. In some alternative embodiments, the supply conduit 116, the discharge conduit 126, and / or the shell may include a spiral in the proximal portion 112 of the shaft 110.

[0026] Alternatively, or additionally, the illustrated cryogenic surgical instrument may include the cryogenic cooling methods disclosed in Patent Document 1 by Skorich et al., filed April 18, 2023, which has the designation “Cryogenic probe.” The disclosure of Patent Document 1 is incorporated herein by reference in its entirety. Exemplary cryogenic fluids may include one or more of nitrous oxide, argon, carbon dioxide, and / or phase-change fluids (e.g., liquid nitrogen). In this specification, “fluid” may mean a substance in a liquid phase, a gaseous phase, and / or a mixture of a liquid phase and a gaseous phase.

[0027] Referring to Figure 1B, the cryogenic fluid supplied from the cryogenic module 108 can flow into an end effector (not shown) through the supply conduit 116 and nozzle 118. Generally, the cryogenic fluid exiting the nozzle 118 can experience higher pressure upstream of the nozzle 118 and expand under significantly lower pressure downstream of the nozzle 118, thereby causing Joule-Thomson expansion and significantly lowering the temperature of the cryogenic fluid. In some exemplary embodiments utilizing nitrous oxide as the cryogenic fluid, nitrous oxide can be supplied as a liquid upstream of the nozzle 118 at a temperature of about 27°C and a pressure of about 800 psi, and the nitrous oxide can have a gas phase or a gas-liquid mixed phase in the end effector at about 45 psi and -68°C. Alternatively, the cryogenic fluid can be supplied as a supercritical fluid. Joule-Thomson expansion continues within the end effector, and the wall 122 is cooled to a degree sufficient for use in cryosurgery (e.g., cryoablation) by, for example, bringing the end effector into contact with the tissue to be removed. For example, depending on the cryogenic fluid used and the state of the fluid, an exemplary flow rate of the cryogenic fluid through the nozzle 118 is approximately 15 cm³ per minute. 3 ~100cm 3 The flow rate can be set to a range exceeding this limit.

[0028] This disclosure intends that, while the cryogenic probe 100 is operating, the cryogenic fluid supplied to and / or discharged from the end effector may cause cooling of the shaft 110. In some situations, the cryogenic fluid flowing through the shaft 110 may become so cold that it produces undesirable thermal effects, such as freezing of non-target tissue or adhesion of the shaft 110 to non-target tissue. For example, during procedures performed in the chest, it may be advantageous to avoid inadvertent freezing of lung tissue and / or around openings through the chest wall or adhesion to lung tissue and / or surrounding areas. Therefore, in the illustrated embodiments, the shaft 110 includes an insulating portion interposed radially between the conduits 116, 126 and the outer surface 136 of the shaft 110. In some exemplary embodiments, the shaft 110 may be configured to provide a higher level of insulation than corresponding portions of similar devices, thus resulting in operational advantages.

[0029] In the illustrated embodiment, the insulating portion may include a vacuum insulating layer 130 radially outward of the discharge conduit 126. In this specification, “vacuum insulating layer” refers to at least a partially vacuumed volume configured to reduce heat transfer, including near vacuum, partial vacuum, and full vacuum. In the illustrated embodiment, the vacuum insulating layer 130 includes a generally annular vacuumed volume at least partially surrounded by the outer surface of the discharge conduit 126.

[0030] In the illustrated embodiment, a thermal barrier element 138 is disposed within the vacuum insulating layer 130. For example, the thermal barrier element 138 may generally include annular ceramic textile material. In alternative embodiments, the thermal barrier element 138 may include other insulating materials that can withstand both cryogenic and brazing temperatures, such as glass fiber, elastomer, foam, silicon, carbon fiber, and composite materials. In some alternative embodiments without vacuum insulation, or in the illustrated embodiment, if the integrity of the vacuumed volume is compromised, the thermal barrier element 138 may be configured to provide sufficient thermal insulation to allow the device to meet desired performance requirements with respect to shaft temperature.

[0031] In the illustrated embodiment, the shaft 110 is configured to provide desired rigidity in the proximal portion 112 and desired flexibility in the distal portion 114 by utilizing a substantially straight-walled configuration in the proximal portion 112 and a substantially spiral configuration in the distal portion 114. In this specification, “spiral” refers to an object having a form or shape that includes a wave-like structure, which is not smooth and can be folded as a curved or meandering winding, and which may or may not be spiral. In particular, in this embodiment, in the proximal portion 112, the supply conduit 116 and the discharge conduit 126 are each formed as substantially straight-walled (e.g., non-spiral) tubes. In the distal portion 114, the discharge conduit 126 and the shell are formed as substantially spiral tubes. In the illustrated embodiment, the spiral is spiral and / or helical. However, in alternative embodiments, other spirals, such as circumferential waves, may be utilized. In some exemplary embodiments, one or more wires 132 connected to the thermocouple 134 may be routed in a generally helical manner along the distal portion 114 of the shaft 110, such as wrapping around the distal portion 114 in a generally helical groove. In some alternative embodiments, the supply conduit 116 and discharge conduit 126 may include a spiral in the generally rigid proximal portion 112 of the shaft 110.

[0032] Figures 2A and 2B show an end effector 200 for use with the cryogenic probe 100. The end effector 200 may comprise a base portion 202 and a head portion 204. The base portion 202 may comprise a threaded portion 206, a flanged portion 208, and a shaft portion 210. The threaded portion 206 may comprise a plurality of helical threads 212 that are inserted into the shaft 110, thereby the threads 212 are coupled to threads in the wall 122 of the shaft 110.

[0033] In some variations, the end effector 200 can be snap-fitted, slide-fitted, or fastened to the shaft 110. In other variations, the end effector 200 can be manufactured by metal injection molding, 3-D printing, or a combination thereof. In other variations, the end effector 200 can be a single piece or a separate component. The end effector 200 can be made of stainless steel, aluminum, titanium, gold-plated copper, alloys of the above materials, or a combination thereof.

[0034] The head portion 204 may comprise a first prong 214, a second prong 216 separated from the first prong 214, and a curved portion 218 between the first prong 214 and the second prong 216. The first prong 214 and the second prong 216 may extend from the curved portion 218 in a direction perpendicular to the longitudinal axis of the shaft 110. The first prong 214 and the second prong 216 may be separated along the longitudinal axis to define a gap 220 in which nerves or tissues are located. Please note that the prongs 214, 216 and the curved portion 218 may extend from the shaft 110 at various angles.

[0035] The curved portion 218 can also extend in a direction perpendicular to the longitudinal axis of the shaft 110. The space 222 can be defined between the curved portion 218 and the base portion 202. The space 222 can facilitate the nerve grasping desired by the user.

[0036] In other configurations, the prongs 214 and 216 can be inclined inward toward the curved portion 218. In other configurations, the first prong of the prongs 214 and 216 can be inclined inward toward the curved portion 218, thereby making the second prong of the prongs 214 and 216 perpendicular to the longitudinal axis of the shaft 110.

[0037] The end effector 200 may have a hollow interior throughout for receiving cryogenic fluid (e.g., liquid nitrogen) from the supply conduit 116. In some embodiments, a gas can be used (e.g., carbon dioxide, nitrous oxide, argon). The end effector 200 may have an overall length of about 0.8 inches (approximately 2.03 cm) to about 1.2 inches (approximately 3.05 cm) (e.g., about 0.963 inches (approximately 2.45 cm)). The end effector 200 may have a maximum width of about 0.2 inches (approximately 0.51 cm) to about 0.3 inches (approximately 0.76 cm) (e.g., about 0.225 inches (approximately 0.57 cm)). The first prong 214 and the second prong 216 can each have a diameter of approximately 0.1 inches (approximately 0.25 cm) to approximately 0.2 inches (approximately 0.51 cm) (for example, approximately 0.15 inches (approximately 0.38 cm)). The end effector 200 can have a wall thickness of approximately 0.01 inches (approximately 0.025 cm) to approximately 0.02 inches (approximately 0.05 cm) (for example, approximately 0.015 inches (approximately 0.038 cm)) to promote uniform freezing around the end effector 200. In other variants, the wall thickness may vary across the entire cross-section of the end effector 200.

[0038] The distance between the central axis of the first prong 214 and the central axis of the second prong 216 can be approximately 0.35 inches (approximately 0.89 cm) to approximately 0.45 inches (approximately 1.14 cm) (for example, approximately 0.39 inches (approximately 0.99 cm)). The gap between the prongs 214 and 216 can be approximately 0.15 inches (approximately 0.38 cm) to approximately 0.2 inches (approximately 0.51 cm) (for example, approximately 0.18 inches (approximately 0.46 cm)). The length of the end effector 200 from the curved section 218 to the distal ends of the prongs 214 and 216 can be approximately 0.5 inches (approximately 1.27 cm) to approximately 0.6 inches (approximately 1.52 cm) (for example, approximately 0.55 inches (approximately 1.40 cm)).

[0039] As shown in Figure 2B, the cross-sections of the first prong 214 and the second prong 216 can be substantially rectangular. In some variations, the cross-sections can be circular, elliptical, square, or any combination thereof. The edges 224 of the prongs 214, 216 may have tapered surfaces so that the edges 224 do not damage tissue when the end effector 200 is advanced to the target site. The prongs 214, 216 have a constant cross-section along their length, which can provide a constant gas flow during the procedure.

[0040] The cross-sections of prongs 214 and 216 can be approximately 0.15 inches (approximately 0.38 cm) in length and approximately 0.1 inches (approximately 0.25 cm) in width. The dimensions of prongs 214 and 216 are such that the smallest nerve (approximately 1 mm) and largest nerve (approximately 27 mm) within the leg can come into contact with the end effector 200 for freezing during the amputation procedure.

[0041] Figure 3A shows a side view of the shaft 110, which includes an end effector 200 and a nozzle 118. The nozzle 118 can supply cryogenic fluid to the end effector 200 at a controlled flow rate. The nozzle 118 can be positioned at various locations along the length of the shaft 110. For example, the distal end of the nozzle 118 can be positioned approximately 0.02 inches (approximately 0.05 cm) from the distal end of the shaft.

[0042] As shown in Figure 3B, the distal end of the nozzle 118 can be aligned with the first prong 214 and positioned approximately 0.278 inches (0.71 cm) from the distal end of the shaft 110 at the proximal end of the curved section 218. As shown in Figure 3C, the nozzle 118 can be positioned approximately 0.513 inches (approximately 1.30 cm) from the distal end of the shaft 110 at the curved section 218 of the end effector 200. To extend the position of the nozzle 118, the length of the shaft 110 and the corresponding components can be adjusted accordingly. The position of the nozzle 118 and the flow rate of the cryogenic fluid may affect the flow of the cryogenic fluid in the prongs 214, 216 and thus affect the consistency of the procedure. The nozzle 118 may be equipped with an orifice that produces a cone jet or a helix nozzle that produces a spiral jet.

[0043] In some modifications, two or more nozzles can be used to direct the cryogenic fluid into the end effector 200. In some modifications, the nozzle 118 can be bent into the prongs 214, 216 to direct the flow into the prongs 214, 216. In some modifications, baffles for thicker sections can be used to reinforce the walls of the end effector 200 to promote cooling in specific areas of the end effector. In some modifications, tracks can be placed within the prongs 214, 216 to direct the flow within the prongs 214, 216. In some modifications, a nozzle 118 with multiple orifices can be provided to direct the flow into the prongs 214, 216.

[0044] The end effector 200 can be configured to contact one or more of the following nerves or nerve groups: the saphenous nerve, deep peroneal nerve, sciatic nerve, deep peroneal nerve bundle, superficial peroneal nerve, tibial nerve, tibial nerve bundle, medial sural cutaneous nerve, lateral sural cutaneous nerve, lateral communicating branch, and superficial peroneal nerve.

[0045] The End Effector 200 allows for stable and efficient transwall freezing (i.e., within 60 seconds) of nerves or tissues of various sizes and locations. Freezing can be achieved as proximal as possible so that the nerve terminal can be severed and then retracted, protected by the tissue at the severed end.

[0046] In some methods, while the user is in different positions and / or orientations around the operating table, the first prongs 214 and second prongs 216 of the end effector 200 can be rotated by the user to isolate nerves from surrounding structures and freeze multiple nerves at different angles.

[0047] In some methods, the nerve can be stabilized by passing it in a zigzag pattern between the first prong 214 and the second prong 216, thereby positioning the end effector 200 for cryoablation. In other variations, the nerve can be placed between the first prong 214 and the second prong 216, positioned above and / or around the curved portion 218 of the end effector. In other variations, the nerve can be twisted or wrapped around one of the prongs. In other variations, the nerve can be positioned across the entire length of the prongs 214, 216 so that the user can manipulate the nerve by pulling the end effector 200 toward themselves. In other variations, the nerve can be positioned by pressing the nerve from its front by the end effector 200. Thus, the cryogenic probe 100 can allow force to be applied to the nerve in various ways (i.e., the user can apply constant or intermittent pressure).

[0048] The surfaces of the first prong 214 and the second prong 216 can enable nerve contact and thus engage with various nerves with diameters ranging from 1 mm to 27 mm, such as those present in the lower limb nerves. Thus, the user can maintain close control of the end effector 200 during cryoablation due to nerve control via the prongs 214 and 216.

[0049] In other variations, the end effector 200 may be equipped with prongs for constricting the tissue before freezing. In other variations, the end effector 200 may be equipped with cutting elements on the prongs for cutting the tissue.

[0050] In other variants, the end effector 200 can be used on lobulated structures, blood vessels, solid organs, or other parts of the body (e.g., upper limbs). The cryogenic probe 100 can freeze nerves before or after nerve or limb transection, with or without additional visualization.

[0051] Figures 4A to 4G show variations of the end effector that can be used with the cryogenic probe 100. Figure 4A shows an end effector 200 with two curved prongs 400, 402 that extend symmetrically and form a C-shape at the end. Figure 4B shows an end effector 200 with a single prong 404 that extends 90° from the shaft 110.

[0052] Figure 4C shows an end effector 200 with two curved prongs. The first curved prong 406 is longer than the second curved prong 408 and forms an opening between the prongs at a position offset from the longitudinal axis of the shaft 110.

[0053] Figure 4D shows an end effector 200 having prongs 410, 412 parallel to the longitudinal axis of the shaft 110. The prongs 410, 412 may optionally have base portions 414, 416 that connect the prongs 410, 412 to the shaft 110. Figure 4E shows an end effector 200 having a prong 418 formed as a semicircular hook at the end 420, the prong 418 extending perpendicular to the longitudinal axis of the shaft. Figure 4F shows an end effector 200 having a curved portion 218 extending at approximately 45° from a first plane perpendicular to the longitudinal axis of the shaft 110 and at approximately 90° from a second plane perpendicular to the longitudinal axis of the shaft 110, a first prong 214, and a second prong 216.

[0054] Figure 4G shows the end effector 200, which includes a curved section 218 extending at approximately 45° from the longitudinal axis of the shaft 110, a first prong 214, and a second prong 216.

[0055] Unless otherwise specifically indicated, it will be understood that the descriptions of structure, function, and / or method relating to any exemplary embodiment herein can be applied to any other exemplary embodiment. More generally, it is within the scope of this disclosure to use any one or more features of any one or more exemplary embodiments described herein in relation to any one or more features of any other exemplary embodiment described herein. Accordingly, any combination of features or embodiments described herein is within the scope of this disclosure.

[0056] From the above description and summary of the invention, it should be clear to those skilled in the art that the methods and apparatus described herein constitute exemplary embodiments of the disclosure, but that the scope of the disclosure contained herein is not limited to the exact embodiments described above, and that modifications can be made without departing from the scope of the disclosure. Similarly, it should be understood that not all identified advantages or objectives disclosed herein are necessary to satisfy the scope of the disclosure, as such advantages may exist even if they could not be explicitly discussed herein.

[0057] While the present invention has been described with reference to exemplary embodiments, those skilled in the art will understand that various modifications can be made and elements of the present invention can be substituted with equivalents without departing from the scope of the invention. In addition, many modifications can be made to adapt specific systems, devices, or components thereof to the teachings of the present invention without departing from the basic scope of the invention. Thus, the present invention is not limited to the specific embodiments disclosed for carrying out the invention, and it is intended that the present invention includes all embodiments within the scope of the appended claims. Furthermore, the use of terms such as "first," "second," etc., does not indicate order or importance, but rather, terms such as "first," "second," etc., are used to distinguish one element from another.

[0058] The terms used herein are for the purpose of describing specific embodiments and are not intended to limit the invention. In this specification, the singular forms “a,” “an,” and “the” are intended to include the plural form unless explicitly indicated by the context. It will be further understood that when the terms “comprise” and / or “comprising” are used herein, they specify the presence of the described feature, integer, step, action, element, and / or component, and do not exclude the presence or addition of one or more other features, integers, steps, actions, elements, components, and / or groups thereof.

[0059] All means or step-plus-functional elements within the following claims, corresponding structures, materials, actions, and equivalents are intended to include any structures, materials, or actions for carrying out the function in combination with other elements described in the claims, as specifically described in the claims. The description of the present invention is presented for illustrative and explanatory purposes and is not intended to be exhaustive or to limit the invention to the disclosed forms. A number of modifications and variations will become apparent to those skilled in the art without departing from the scope and spirit of the invention. The embodiments are selected and described to best illustrate the principles and practical applications of the invention and to enable those skilled in the art to understand the invention in terms of various embodiments, including various modifications appropriate for a particular use to be intended. [Explanation of Symbols]

[0060] 100 Cryogenic probes 102 Distal end 104 Handle 106 Connection Elements 108 Cryogenic Modules 110 shaft 112 Proximal portion 114 Distal portion 116 Supply Conduit 118 nozzles 122 Wall 126 Discharge conduit 128 Discharge pipe end 130 Vacuum insulating layer 132 wires 134 Thermocouples 136 Exterior 138 Thermal barrier elements 200 End Effectors 202 Base section 204 Head section 206 Threaded part 208 Flanged section 210 Shaft section 212 spiral threads 214, 216 prongs 218 Curved section 224 Edge 404 Prong 408 Prong 410, 412 prongs 418 Prong 420 End

Claims

1. A cryogenic probe, The handlebars and A shaft having a proximal end coupled to the handle, wherein the shaft defines a longitudinal axis, An end effector coupled to the distal end of the shaft, the end effector comprising a first prong, a second prong, and a curved portion between the first prong and the second prong, wherein the first prong and the second prong are configured to receive cryogenic fluid, and the first prong and the second prong extend perpendicular to the longitudinal axis and are spaced apart along the longitudinal axis, A supply conduit configured to supply cryogenic fluid to the end effector, A cryogenic probe equipped with the following features.

2. The cryogenic probe according to claim 1, further comprising a discharge conduit configured to discharge cryogenic fluid from the end effector.

3. The cryogenic probe according to claim 2, wherein the discharge conduit is arranged concentrically around the supply conduit.

4. The cryogenic probe according to claim 1, further comprising a vacuum insulating layer disposed around the supply conduit.

5. The cryogenic probe according to claim 4, further comprising a tubular thermal barrier element disposed within the vacuum insulating layer.

6. The cryogenic probe according to claim 5, wherein the thermal barrier element is constructed from at least one of ceramic, glass fiber, elastomer, foam, silicon, carbon fiber, and composite material.

7. The cryogenic probe according to claim 1, wherein the end effector is inserted into the distal end of the shaft.

8. The cryogenic probe according to claim 7, wherein the end effector is coupled to the distal end of the shaft via a screw thread.

9. The cryogenic probe according to claim 1, further comprising a nozzle at the distal end of the supply conduit.

10. The cryogenic probe according to claim 9, wherein the nozzle has a terminal end in the curved portion.

11. The cryogenic probe according to claim 9, wherein the nozzle has a terminal end near the curved portion.

12. The cryogenic probe according to claim 1, wherein the cross-sections of the first prong and the second prong are rectangular.

13. A method for freezing one or more nerves of a patient, wherein the method is A step of advancing a cryogenic probe to a target site, wherein the cryogenic probe comprises a handle, a shaft having a proximal end coupled to the handle, and an end effector coupled to the distal end of the shaft, the end effector comprising a first prong, a second prong, and a curved portion between the first and second prongs, the first and second prongs configured to receive cryogenic fluid, the first and second prongs extending perpendicular to the longitudinal axis of the shaft and spaced apart along the longitudinal axis, The steps include positioning the end effector to grasp one or more nerves, The steps include supplying cryogenic fluid from a supply conduit to the end effector, The steps include freezing one or more nerves by applying the end effector to the surface of one or more nerves, Methods that include...

14. The method according to claim 13, further comprising the step of discharging cryogenic fluid from the end effector through a discharge conduit.

15. The method according to claim 13, further comprising a nozzle in the supply conduit.

16. The method according to claim 15, wherein the nozzle has an end portion in the curved portion.

17. The method according to claim 15, wherein the nozzle has a terminal end near the curved portion.

18. It is a medical device, The handlebars and A shaft having a proximal end coupled to the handle, wherein the shaft defines a longitudinal axis, An end effector coupled to the distal end of the shaft, the end effector comprising a first prong and a second prong, the first prong and the second prong configured to receive fluid, and the first prong and the second prong extending at a certain angle with respect to the longitudinal axis, A supply conduit configured to supply fluid to the end effector, A medical device equipped with the following features.

19. The medical device according to claim 18, wherein the fluid is a cryogenic fluid.

20. The medical device according to claim 18, further comprising a nozzle at the distal end of the supply conduit.

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