WO2023083047A1 - J-t槽套管的冷冻消融针 - Google Patents

J-t槽套管的冷冻消融针 Download PDF

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Publication number
WO2023083047A1
WO2023083047A1 PCT/CN2022/128869 CN2022128869W WO2023083047A1 WO 2023083047 A1 WO2023083047 A1 WO 2023083047A1 CN 2022128869 W CN2022128869 W CN 2022128869W WO 2023083047 A1 WO2023083047 A1 WO 2023083047A1
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WO
WIPO (PCT)
Prior art keywords
needle
groove
sleeve
slot
distal end
Prior art date
Application number
PCT/CN2022/128869
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English (en)
French (fr)
Inventor
孙加源
杨迟
徐彬凯
谢芳芳
顾川佳
冯歆童
Original Assignee
上海市胸科医院
上海导向医疗系统有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 上海市胸科医院, 上海导向医疗系统有限公司 filed Critical 上海市胸科医院
Priority to CA3238025A priority Critical patent/CA3238025A1/en
Priority to AU2022386219A priority patent/AU2022386219A1/en
Publication of WO2023083047A1 publication Critical patent/WO2023083047A1/zh

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00005Cooling or heating of the probe or tissue immediately surrounding the probe
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577Ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00696Controlled or regulated parameters
    • A61B2018/00714Temperature
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0293Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques using an instrument interstitially inserted into the body, e.g. needle

Definitions

  • the invention relates to the technical field of cryoablation, in particular to a cryoablation needle for a J-T groove sleeve.
  • Cryoablation a treatment modality that uses low temperature to destroy diseased tissue, is considered to be an efficient and minimally invasive method for treating malignant tumors.
  • the cryoablation technique is easy to operate, has few complications, and can effectively relieve pain.
  • the boundary of the ice ball formed by ablation is clear and easy to observe. It can safely ablate lesions adjacent to large blood vessels or important organs; cryoablation can also use multiple needles to freeze , making the ablation range larger, suitable for large lesions and lesions with irregular shapes.
  • Intracellular ice damage directly damages the cell structure, so it is more destructive to cells.
  • the development of cryoablation technology has gone through three stages.
  • the first stage is liquid nitrogen delivery refrigeration technology.
  • This technology is to deliver liquid nitrogen at -196°C to the needle of the cryoablation needle through a low driving pressure to achieve the purpose of cryoablation.
  • the cold source of this technology relies entirely on liquid nitrogen, and the liquid nitrogen is located in the host or the liquid nitrogen barrel, which has a long delivery distance from the needle.
  • the temperature of the needle can reach -196 °C.
  • the cooling rate of liquid nitrogen refrigeration is the slowest in the existing technology;
  • the second stage is the direct throttling refrigeration technology, which uses the "Joule Thomson effect" (Joule Thompson Effect, referred to as J-T) principle, the ultra-high pressure gas at room temperature is delivered to the J-T groove (capillary tube that produces the J-T effect) inside the cryoablation needle to directly throttle to generate low temperature, and its cooling rate is relatively the fastest in current technology , but the J-T grooves and finned tubes inside the needle will still consume part of the cooling capacity and delay the cooling time.
  • the ultra-high pressure gas used is not popular and expensive, which makes it difficult to promote this technology;
  • the three-stage is pre-cooled throttling refrigeration technology.
  • the present invention proposes a cryoablation needle with a J-T slot cannula to solve the problem of slow cooling rate in the prior art.
  • the present invention provides a cryoablation needle with a J-T groove sleeve, which includes: a vacuum wall, a J-T groove, and a J-T groove sleeve; wherein,
  • the vacuum wall includes: a needle bar and an inner tube
  • the distal end of the needle shaft has a needle
  • the inner tube is passed through the needle bar, and an interlayer is formed between the inner tube and the needle bar, and the interlayer is an interlayer capable of forming a vacuum;
  • the J-T groove sleeve sleeve is overlaid on the distal end of the J-T groove or inside is sleeved on the distal end of the J-T groove; the distal end of the J-T groove is the end of the J-T groove close to the needle;
  • the J-T slot and the J-T slot casing are pierced through the inner tube;
  • the section where the interlayer is located is a vacuum insulation area
  • the section where the first preset distance is located is a targeting area
  • the far end of the J-T groove is located in the vacuum insulation area
  • the J-T groove sleeve can move relative to the J-T groove along the axial direction of the vacuum wall, and a dynamic seal is formed between the J-T groove sleeve and the J-T groove;
  • the distal end of the J-T groove sleeve can switch between at least two adjustment positions relative to the vacuum wall, and the at least two adjustment positions include: a first adjustment position and a second adjustment position;
  • said first regulatory position is located within said targeting region
  • the second adjustment position is located in the vacuum insulation area
  • the second preset distance at least ensures that the ice ball formed by freezing covers the needle
  • the third preset distance at least ensures that the refrigerant returns directly from the vacuum heat insulation area after being sprayed out from the J-T slot casing; the far end of the vacuum heat insulation area is the A vacuum insulation zone is located near the end of the needle.
  • it further includes: a J-T slot sleeve adjustment device, the J-T slot sleeve adjustment device is used to switch the distal end of the J-T slot sleeve between the at least two adjustment positions.
  • a J-T slot sleeve adjustment device the J-T slot sleeve adjustment device is used to switch the distal end of the J-T slot sleeve between the at least two adjustment positions.
  • the J-T groove sleeve adjustment device includes: a push tube and a mandrel; wherein,
  • the mandrel is arranged along the axial direction of the vacuum wall;
  • the push tube is passed through the mandrel
  • the far end of the push tube is connected to the proximal end of the J-T groove sleeve; the far end of the push tube is the end of the push tube close to the needle;
  • the push tube and the J-T groove sleeve can be controlled to move synchronously along the axis direction, so as to switch the adjustment position of the distal end of the J-T groove sleeve.
  • it further includes: a sealing assembly, the sealing assembly is used to form a dynamic seal between the mandrel and the push tube.
  • the sealing assembly includes: a sealing ring, a sealing groove and a sealing pressing piece; wherein,
  • the sealing groove is fixed and sealed with the proximal end of the mandrel
  • the sealing ring is arranged between the mandrel and the sealing groove, and the sealing pressure piece is arranged between the sealing ring and the sealing groove;
  • the sealing pressing piece can be radially extruded in a controlled manner, so that the sealing ring radially extrudes the mandrel, so that a dynamic seal is formed between the mandrel and the push tube.
  • it also includes: a spring and a locking member; wherein,
  • One end of the spring can move synchronously with the distal end of the J-T groove sleeve, and is also connected to the locking member; the locking member can enter and leave the locking position;
  • the other end of the spring is fixed relative to the vacuum wall
  • the spring is limited by the retaining member to maintain a deformed state, and the far end of the J-T groove sleeve is located at the second adjustment position;
  • the deformation state is a state of compression or a state of tension
  • the spring When the locking member is out of the locking position, the spring can generate a restoring force from the deformed state to a natural state, and the restoring force can drive the distal end of the J-T groove sleeve to automatically
  • the second adjustment position enters the first adjustment position.
  • the locking member includes: a positioning pin and a C-shaped ring; wherein,
  • the positioning pin is arranged on the C-shaped ring
  • the C-shaped ring is coated on the outer wall whose position relative to the vacuum wall is fixed;
  • the positioning pin is used to keep the spring in the deformed state.
  • it also includes: a slider and a handle; wherein,
  • the handle is arranged at the proximal end of the vacuum wall, and the handle is fixed relative to the vacuum wall; the proximal end of the vacuum wall is the end of the vacuum wall away from the needle;
  • the slider is connected to the proximal end of the push tube, and the slider is also directly or indirectly connected to the locking member; the proximal end of the push tube is the end of the push tube away from the needle;
  • the slider, the push tube, and the J-T slot sleeve can be controlled to move synchronously along the axis direction to switch the adjustment position of the distal end of the J-T slot sleeve;
  • the handle is provided with a handle positioning groove
  • the slider is provided with a slider positioning groove
  • the positioning pin can be controlled and inserted into the slider positioning groove and the handle positioning groove at the same time, so that the position of the slider, the handle and the vacuum wall are relatively fixed. At this time, the position of the J-T groove sleeve The distal end is located at the second adjustment position.
  • the vacuum wall also includes: an outer tube; wherein,
  • the distal end of the outer tube is in sealing connection with the proximal end of the needle rod, and the proximal end of the outer tube is in sealing connection with the proximal end of the inner tube;
  • One end of the needle, the proximal end of the outer tube is the end of the outer tube away from the needle;
  • the outer diameter of the outer tube is larger than the outer diameter of the needle shaft, and the inner diameter of the outer tube is larger than the inner diameter of the needle shaft;
  • the inner tube includes in turn: a front section of the inner tube and a rear section of the inner tube, the outer diameter of the rear section of the inner tube is larger than the outer diameter of the front section of the inner tube, and the inner tube rear section The inner diameter of the outer end of the tube is greater than the inner diameter of the front section of the inner tube;
  • the front section of the inner tube is threaded through the needle bar, and the rear section of the inner tube is threaded through the outer tube.
  • the dynamic sealing point between the J-T groove sleeve and the J-T groove is located at the proximal end of the J-T groove sleeve;
  • the dynamic sealing point is located inside the rear section of the inner tube.
  • it also includes: a temperature measuring line;
  • the far end of the temperature measuring line is the temperature measuring point; the far end of the temperature measuring line is the end of the temperature measuring line close to the needle;
  • the temperature measuring point is set at the far end of the J-T groove casing, and is used for measuring the temperature at the far end of the J-T groove casing.
  • the present invention has the following advantages:
  • the cryoablation needle of the J-T slot sleeve provided by the present invention, by setting the J-T slot sleeve on the J-T slot, the J-T slot sleeve can move axially relative to the J-T slot, when the distal end of the J-T slot sleeve is located Inside the vacuum insulation area, the refrigerant fluid is introduced into the J-T tank to start freezing, and all the delivery lines at the host end and the cryoablation needle end can be pre-purged (cooled), and the pre-purge process will not cause damage to the target area.
  • the section consumes cooling energy, so all the cooling energy is used to cool the delivery pipeline, so the cooling delivery pipeline process has the fastest rate; and the target area does not release any cooling energy during the pre-purge process, therefore, the target There will be no frost and icing phenomenon in the direction area, and formal surgery can be directly performed;
  • the cryoablation needle of the J-T slot sleeve provided by the present invention can keep the pre-purge mode turned on after the needle test process is completed, and the inside of the vacuum insulation area (the far end of the J-T slot sleeve) is kept at the lowest temperature, Since the target area does not release any cold energy, operations such as puncture and scanning positioning can be performed. After the puncture is in place, it can be adjusted to the freezing mode. At this time, the inside of the target area will instantly drop from normal temperature to the lowest temperature, so It can realize the extreme rapid cooling of the formal operation link;
  • the cryoablation needle provided by the present invention has a wide application range and can be applied to all current cryoablation technologies: liquid nitrogen delivery refrigeration technology, direct throttling refrigeration technology, and precooled throttling refrigeration technology ; It is not only suitable for percutaneous puncture cryoablation instruments, but also for cryoablation instruments operated through natural orifices.
  • Fig. 1 is a schematic diagram of the J-T groove adjustment of the rigid cryoablation needle of the J-T groove cannula according to an embodiment of the present invention
  • Fig. 2 is a schematic diagram of the J-T groove adjustment of the flexible cryoablation needle of the J-T groove cannula according to an embodiment of the present invention
  • Fig. 3 is a pre-purging mode diagram of the rigid cryoablation needle of the J-T groove sleeve of a preferred embodiment of the present invention
  • Fig. 4 is the enlarged view of part I in Fig. 3;
  • Fig. 5 is a frozen mode diagram of the rigid cryoablation needle of the J-T groove sleeve of a preferred embodiment of the present invention
  • Figure 6 is an enlarged view of part II in Figure 5;
  • Fig. 7 is a schematic diagram of the vacuum wall of the flexible cryoablation needle of the J-T slot cannula according to a preferred embodiment of the present invention.
  • Fig. 8 is a pre-purging mode diagram of the flexible cryoablation needle of the J-T slot sleeve in a preferred embodiment of the present invention
  • Fig. 9 is a freezing mode diagram of the flexible cryoablation needle of the J-T slot sleeve in a preferred embodiment of the present invention.
  • Fig. 10 is a diagram of the core adjustment mechanism of the flexible cryoablation needle of the J-T slot cannula according to a preferred embodiment of the present invention.
  • Fig. 11 is a schematic diagram of a slider in a preferred embodiment of the present invention.
  • Fig. 12 is a schematic diagram of a clasp in a preferred embodiment of the present invention.
  • first and second are used for description purposes only, and cannot be understood as indicating or implying relative importance or implicitly indicating the quantity of indicated technical features.
  • a feature defined as “first” and “second” may explicitly or implicitly include one or more of these features.
  • a plurality means a plurality, such as two, three, four, etc., unless otherwise specifically defined.
  • FIG. 1 and FIG. 2 are schematic diagrams of J-T groove adjustment of a cryoablation needle with adjustable J-T groove position according to an embodiment of the present invention.
  • the cryoablation needle with adjustable J-T slot position in this embodiment includes: vacuum wall 2, J-T slot 1 and J-T slot sleeve 18;
  • the vacuum wall 2 includes: a needle bar 21 and an inner tube 22 , and the distal end of the needle bar 21 has a needle head 211 .
  • the inner tube 22 is pierced through the needle bar 21, and an interlayer is formed between the inner tube 22 and the needle bar 21.
  • the interlayer is an interlayer capable of forming a vacuum, which can be a permanent vacuum interlayer or a real-time vacuum interlayer; the vacuum interlayer serves as heat insulation , To prevent frostbite of normal tissue.
  • the first preset distance can be understood as the distance along the axial direction of the vacuum wall
  • the far end of the inner tube 22 is an inner tube 22 near the end of the needle 211.
  • the section area where the vacuum wall is distributed along its axial direction because the vacuum interlayer can play the role of heat insulation, so the section area where the interlayer is located is the vacuum heat insulation area 26, and the section where the first preset distance is located
  • the region is targeted region 25.
  • the sleeve 18 of the J-T groove 1 is sleeved on or inside the distal end of the J-T groove 1; the distal end of the J-T groove 1 is the end of the J-T groove 1 near the needle 211.
  • the J-T slot 1 and the J-T slot casing 18 are passed through the inner tube 22 .
  • the J-T slot casing 18 is overlaid on the distal end of the J-T slot 1 .
  • the J-T slot sleeve 18 can also be sleeved on the distal end of the J-T slot 1 .
  • the J-T groove sleeve 18 can move relative to the J-T groove 1 along the axial direction of the vacuum wall, and a dynamic seal is formed between the J-T groove sleeve 18 and the J-T groove 1 .
  • the distal end of the J-T groove sleeve can switch between at least two adjustment positions relative to the vacuum wall (for example, the switch can be realized by moving along the axial direction of the vacuum wall), and the at least two adjustment positions include: the first adjustment position and the second adjustment position. Two adjust the position.
  • the distal end of the J-T groove sleeve 18 is at the first adjustment position, the distal end of the J-T groove sleeve 18 is located in the targeting area 25, which can be understood as being in the freezing mode, as shown by the dotted line in FIGS. 1 and 2 ;
  • the far end of the J-T groove 1 is the end of the J-T groove 1 close to the needle 211 .
  • the far end of the J-T slot sleeve 18 is at the second adjustment position, the far end of the J-T slot sleeve 18 is located in the vacuum insulation zone 26, which can be understood as being in the pre-purge mode, as shown by the solid lines in Figures 1 and 2 part shown.
  • the distal end of the J-T groove sleeve 18 When the distal end of the J-T groove sleeve 18 is at the first adjustment position, along the axial direction of the vacuum wall, the distal end of the J-T groove sleeve 18 has a second preset distance from the needle, and the second preset distance at least ensures that freezing is formed.
  • the ice ball covers the needle, that is, the refrigerant fluid is ejected from the J-T groove sleeve and returns from the inside of the target area and the inside of the vacuum insulation area. A heat exchange occurs.
  • the far end of the J-T slot bushing 18 When the far end of the J-T slot bushing 18 is at the second adjustment position, along the axial direction of the vacuum wall, the far end of the J-T slot bushing 18 has a third preset distance from the far end of the vacuum insulation zone, and the third preset Set the distance at least to ensure that the refrigerant medium returns directly from the vacuum insulation area after being sprayed out from the J-T slot casing.
  • the medium refrigerant does not release any cold energy in the targeted section; the far end of the vacuum heat insulation zone is the end of the vacuum heat insulation zone close to the needle.
  • the first preset distance, the second preset distance and the third preset distance can be understood as the distances along the axial direction of the vacuum wall 2 .
  • the axial direction mentioned later can be understood as the axial direction of the vacuum wall 2 .
  • the vacuum wall is a hard material vacuum wall, which can be applied to a percutaneous cryoablation instrument.
  • the needle 211 is in the form of a needle point.
  • the vacuum wall is a flexible material vacuum wall, which can be applied to an ablation device through a natural cavity.
  • the needle 211 is in the form of an arc.
  • the needle shaft 21 and the inner tube 22 can be made of soft non-metallic material or freely bendable metal material, such as: PTFE or PTFE braided tube or stainless steel corrugated tube.
  • the process of using the above-mentioned cryoablation needle with double J-T slots is as follows: before the operation, take out the cryoablation needle in the pre-purge mode, connect it to the host computer, and place the needle shaft 21 of the cryoablation needle (at least the target area 25) Insert it into normal saline, turn on the knife test function, perform the rewarming link first, and when the needle temperature rises to a certain temperature value within a certain period of time, it proves that the rewarming function is normal. Immediately afterwards, the program automatically executes the freezing link. When the temperature of the needle drops to a certain temperature within a certain period of time, it proves that the freezing function is normal.
  • the time for the needle to maintain the lowest temperature can be appropriately extended to fully pre-purge, and then the test will automatically stop. knife.
  • the freezing process it can be observed whether there is frosting in the vacuum insulation area 26. If there is no frost, it proves that the heat insulation function is normal.
  • the needle immersed in physiological saline has air leakage. If not, it proves that the airtightness is normal.
  • the delivery pipelines of the host machine and the cryoablation needle have all completed pre-purging (cooling).
  • the freezing function (or the separately set pre-purge function) can be turned on first, and the freezing at this stage can be carried out at a lower working pressure, or intermittent ventilation, so that the temperature at the far end of the J-T tank can be maintained at The lowest temperature while saving gas consumption.
  • the needle can be punctured percutaneously under the guidance of imaging, so that the needle can reach the expected tumor location.
  • the movement of the J-T slot to the far end can be adjusted, stopped at the first adjustment position, and switched to the freezing mode. Since the entire delivery pipeline is already in a low temperature state, the cooling heat load of the cryoablation needle only leaves the target area 25 and the tumor tissue outside it.
  • the temperature at the distal end of the J-T groove can still be maintained.
  • the outer wall of the target area 25 will instantly drop from normal temperature to below -100°C.
  • the operation time for ablation of the same size tumor is shortened, or a larger ablation area (ice puck) is generated in the same time.
  • the tumor cells undergo intracellular ice damage. The probability is greatly increased, and then the freezing damage of tumor cells is more thorough, and the ablation effect is better.
  • it also includes: a J-T slot sleeve adjusting device, the J-T slot sleeve adjusting device is used to switch the distal end of the J-T slot sleeve between at least two adjustment positions.
  • the J-T groove bushing adjustment device includes: a push tube 17 and a mandrel 3, please refer to FIGS. 3, 5, 8, and 9.
  • the mandrel 3 is arranged along the axial direction of the vacuum wall 2 ; the push tube 17 is passed through the mandrel 3 .
  • the distal end of the push tube 17 is connected to the proximal end of the J-T groove sleeve 18; the distal end of the push tube 17 is the end of the push tube 17 close to the needle 211.
  • the push tube 17 and the J-T slot sleeve 18 can be controlled to move synchronously along the axial direction to switch the adjustment position of the distal end of the J-T slot sleeve 18 .
  • it further includes: a sealing assembly 5 used for forming a dynamic seal between the mandrel 3 and the push tube 17 .
  • the sealing assembly 5 includes: a sealing ring 51 , a sealing groove 52 and a sealing pressure piece 53 , please refer to FIGS. 3 , 5 , 8 , and 9 .
  • the sealing ring 51 is placed in the sealing groove 52, the sealing pressure piece 53 is screwed into the sealing groove 52 in the axial direction, the sealing ring 51 is fixed between the sealing groove 52 and the sealing pressure piece 53, and the mandrel 3 is inserted into the sealing ring 51 Then, the seal ring 51 undergoes radial extrusion deformation between the mandrel 3 and the seal groove 52 to form a dynamic seal.
  • the sealing ring 51 may be a rubber sealing ring, such as a nitrile O-ring, or a low temperature resistant fluoropolymer + metal spring pan-sealing sealing ring.
  • the vacuum wall of the flexible cryoablation needle may further include: a vacuum tee 28 , a vacuum connecting tube 291 , a vacuum hose 292 and a gas return connecting tube 293 , please refer to FIG. 7 .
  • the proximal end of the inner pipe 22 is connected and sealed with the far end of the return air connecting pipe 27, the proximal end of the outer pipe 23 is connected and sealed with the tee connection part 281, and the proximal end of the vacuum tee 28 is connected and sealed with the return air connecting pipe 27.
  • the far end of the vacuum connecting pipe 291 is inserted into the tee branch 282, and the vacuum hose 292 is inserted into the vacuum connecting pipe 291.
  • the gap between the inner pipe 22 and the outer pipe 23 can be maintained. Vacuum state can prevent frostbite to normal natural cavity wall.
  • a shunt pipe 294 which is used to seal the gap between the intake pipe 6, the air return pipe 7 and the mandrel 3; end to seal, please refer to Figure 8, 9.
  • the adjustment of the position of the sleeve of the J-T slot can be adjusted manually back and forth, or through a prefabricated spring 120 , and also includes: a locking member 10 .
  • one end of the spring 120 can move synchronously with the distal end of the push tube 17, and is also connected with the locking member 10; the locking member 10 can enter and leave the locking position.
  • the other end of the spring 120 is fixed relative to the vacuum wall.
  • the spring 120 can generate a restoring force from the deformed state to the natural state, and the restoring force can drive the push tube 17 to move, and then drive the J-T groove sleeve 18 to enter from the first adjustment position.
  • the second adjustment position please refer to Figures 5 and 9.
  • the relative position between the far end of the spring 120 and the vacuum wall remains unchanged, the proximal end of the spring 120 is connected to the retaining member 10, and when the J-T groove sleeve 18 is at the first adjustment position, the deformation state of the spring 120 is pulling. stretched state, please refer to Figure 3.
  • the retaining member 10 is out of the retaining position, the restoring force (tension) of the spring 120 drives the push tube to move to the distal end, and then drives the J-T groove sleeve 18 to enter the second adjusting position from the first adjusting position, please refer to FIG. 5 .
  • the limiting position of the component 10 remains in the compressed state, and the J-T slot sleeve 18 is at the first adjustment position, please refer to FIG. 8 .
  • the restoring force (elastic force) of the spring 120 drives the push tube 17 to move to the distal end, and then drives the J-T groove sleeve 18 to enter the second adjusting position from the first adjusting position, please refer to FIG. 9 .
  • the locking member 10 includes: a positioning pin 102, as shown in FIGS. 3 and 8 .
  • a slider 8 and a handle 9 it also includes: a slider 8 and a handle 9, please refer to FIGS. 3 , 5 , 8 , and 9 .
  • the handle 9 is arranged at the proximal end of the cryoablation needle, and its relative position to the vacuum wall is fixed for easy grasping.
  • the slider 8 is connected to the proximal end of the push tube 17 , and the slider 8 is directly or indirectly connected to the locking member 10 .
  • the slider 8 , the push tube 17 , and the J-T slot sleeve 18 can be controlled to move synchronously along the axial direction to switch the adjustment position of the distal end of the J-T slot sleeve 18 .
  • the slider 8 includes: a guide pipe 81 arranged along the axial direction of the vacuum wall.
  • the guide tube 81 is provided with a middle fixing hole 83 , and the distal end of the push tube 17 is fixed to the middle fixing hole 83 .
  • the handle 9 is provided with a handle positioning groove 91
  • the slider 8 is provided with a slider positioning groove 82 .
  • the slider 8 further includes: a guide hole 84 for the inlet and outlet air pipes disposed on the guide tube 81 .
  • the air intake pipe 6 and the return air pipe 7 pass through the guide pipe 84 of the air intake and return pipe, please refer to 11.
  • the locking element 10 further includes: a handle part 101 and a C-shaped ring 103 , please refer to FIG. 12 .
  • the handle portion 101 and the positioning pin 102 are arranged on the C-shaped ring 103; the C-shaped ring 103 is wrapped on the outer wall of the handle 9, which can prevent the locking member from falling off in the radial direction.
  • the C-shaped ring 103 when the handle 9 is not included, the C-shaped ring 103 only needs to be coated on the outer wall whose position is fixed relative to the vacuum wall, and the purpose of preventing the retaining member from falling off in the radial direction can also be achieved.
  • it also includes: a spring baffle 27; the relative position between the spring baffle 27 and the vacuum wall is fixed.
  • a spring baffle 27 the relative position between the spring baffle 27 and the vacuum wall is fixed.
  • the far end of the spring 120 is connected to the spring baffle 27, the proximal end of the spring 120 is connected to the guide tube 81 of the slider 8, and the spring drives the slider to drive the push tube to move.
  • it further includes: finned tubes 4 , and the finned tubes 4 are arranged on the outer wall of the mandrel 3 .
  • the proximal end of the finned tube 4 is in sealing connection with the intake pipe 6
  • the distal end of the finned tube 4 is in sealing connection with the proximal end of the J-T groove 1 .
  • the proximal end of the J-T slot 1 is inserted into the far end of the finned tube 4 from the air inlet slot 174 for connection and sealing.
  • the vacuum wall 2 further includes: an outer tube 23 , please refer to FIGS. 3 , 6 , 9 , and 12 .
  • the far-end of outer tube 23 is in sealing connection with the proximal end of needle bar 21, and the proximal end of outer tube 23 is in sealing connection with the proximal end of inner tube 22.
  • the finned tube 4 in order to expand the internal volume of the proximal end of the inner tube, such as: the finned tube 4 can be inserted into the proximal end of the inner tube, or other more parts can be accommodated; because the proximal end of the inner tube The internal volume needs to be enlarged, and thus the internal volume at the proximal end of the vacuum wall also needs to be enlarged.
  • the outer diameter of outer tube 23 is greater than the outer diameter of needle bar 21, and the inner diameter of outer tube 23 is greater than the inner diameter of needle bar 21, and the far-end of outer tube 23 is the end of outer tube 23 near needle 211, and the proximal end of outer tube 23 is outer tube 23. The end of the tube 23 away from the needle 211 .
  • the inner tube 22 sequentially includes: an inner tube front section 221 and an inner tube rear section 222, the outer diameter of the inner tube rear section 222 is greater than the outer diameter of the inner tube front section 221, and the inner tube
  • the inner diameter of the rear section 222 is larger than the inner diameter of the front section 221 of the inner tube.
  • the front section 221 of the inner tube is located inside the needle bar 21, the rear section 222 of the inner tube is located inside the outer tube 23, and the dynamic sealing point between the J-T groove sleeve and the J-T groove is set in the rear section 222 of the inner tube, please refer to Figure 3, 5, 8, 9.
  • a washer 24 please refer to FIGS. 3 and 5 .
  • the gasket 24 is disposed between the outer wall of the distal end of the inner tube 22 and the inner wall of the needle shaft 21 to form a sealed connection.
  • the J-T groove casing 18 includes: a casing main section 181 , a casing sealing section 182 and a casing connecting section 183 . From the far end to the proximal end of the J-T groove, the sleeve main section 181, the sleeve sealing section 182, and the sleeve connection section 183 are distributed in sequence, please refer to Figs. 4 and 6 .
  • the inner diameter of the casing main section 181 is slightly larger than the outer diameter of the J-T groove 1, and a gasket 19 is placed between the casing sealing section 182 and the J-T groove 1, and the J-T groove casing 18 and the
  • the gap of the J-T groove 1 forms a dynamic seal
  • the sealing gasket 19 is preferably made of PTFE
  • the casing sealing section 182 is preferably located inside the distal end of the inner tube rear section 222, so that its influence on the return air is minimized.
  • the sleeve connection section 183 is also radially extruded to reduce the outer diameter, and the sleeve connection section 183 is inserted into the push tube connection section 175 of the push tube 17 and fixed.
  • the dynamic sealing between the J-T sleeve 18 and the J-T groove 1 can also be realized by a Variseal sealing ring.
  • a temperature measuring line 14 the far end of the temperature measuring line 14 is a temperature measuring point 141, and the far end of the temperature measuring line 141 is a temperature measuring point
  • the end of the wire 141 close to the needle 211 please refer to Figs. 3, 5, 8 and 9.
  • the temperature measuring point 141 is set at the far end of the J-T groove casing 18 for measuring the temperature at the far end of the J-T groove casing 18 .
  • the distal end of the J-T groove sleeve 18 When the distal end of the J-T groove sleeve 18 is located in the target area, it is used to monitor the temperature of the tumor center during cryorewarming; when the distal end of the J-T groove sleeve 18 is located in the vacuum insulation area, it is used to During the pre-purge process, the temperature indicates whether the pre-purge is in place.
  • the temperature measuring line 14 runs along the outside of the J-T groove casing 18, and then leads from the inside of the mandrel 3 or the push tube 17 to the outside, and the inside of the mandrel 3 or the push tube 17 is sealed by pouring glue. Please refer to FIG.
  • the inside of the push tube 17 can be introduced from the temperature measuring notch 173, and the inside of the push tube (from the provocation sheet of the temperature measuring notch 173 to the near end of the push tube 17) is filled with glue for sealing.
  • a rewarming line is also included, and the position and arrangement of the rewarming line are consistent with the temperature measuring line, so as to realize the rewarming function. It is preferably low, and the temperature measuring line and/or reheating line adopts T-type enamelled thermocouple wire.
  • an outer sleeve 13 is also provided on the outer wall of the handle 9, please refer to Figures 3, 5, 8,9.
  • the pre-purge mode can be set, that is, the far end of the J-T slot sleeve is located in the vacuum insulation area 26 as the product delivery state, and the operator can directly complete the pre-purge of the product through the process of testing the knife.
  • adjust to the freezing mode that is, the distal end of the J-T groove sleeve is located in the target area 25. After the freezing is turned on, the target area 25 will quickly cool down to lowest temperature.

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Abstract

一种J-T槽套管(18)的冷冻消融针,包括:真空壁(2)、J-T槽(1)及J-T槽套管(18);真空壁(2)包括:针杆(21)以及内管(22);针杆(21)的远端具有针头(211);内管(22)穿设于针杆(21),内管(22)与针杆(21)之间形成夹层;内管(22)的远端与针杆(21)的远端间具有第一预设距离;J-T槽(1)及J-T槽套管(18)套设于内管(22);J-T槽套管(18)套设于J-T槽(1)的远端,J-T槽套管(18)可相对于J-T槽(1)运动;在真空壁(2)沿其轴心方向分布的各段区域中,夹层所处的一段区域为真空隔热区(26),第一预设距离所处的一段区域为靶向区(25);J-T槽套管(18)的远端相对真空壁(2)至少包括两个调节位置,第一调节位置位于靶向区(25)内;第二调节位置位于真空隔热区(26)内。通过J-T槽套管(18)的远端在至少两个调节位置之间切换,大大加快了降温速率。

Description

J-T槽套管的冷冻消融针 技术领域
本发明涉及冷冻消融技术领域,特别涉及一种J-T槽套管的冷冻消融针。
背景技术
冷冻消融是一种利用低温来破坏病变组织的治疗方式,被认为是一种治疗恶性肿瘤高效、微创的方法。冷冻消融技术操作简便、并发症少、可有效镇痛,同时消融形成的冰球边界清晰、便于观察,可安全的消融临近大血管或重要脏器的病灶;冷冻消融还可采取多针冷冻的方式,使消融范围更大,适用于大病灶及形态不规则病灶。
细胞在冷冻过程中,细胞外冰晶首先形成,引起细胞外溶质浓度增大,产生高渗环境,细胞内水分进入细胞外,致使细胞内脱水。失去水分的细胞变得皱缩,细胞膜变形,造成高浓度毒性环境的“溶液损伤”;同时,细胞内形成的冰晶直接损伤细胞器和细胞膜,造成进一步的坏死,俗称“胞内冰损伤”,由于胞内冰损伤直接损伤细胞结构,因此其对细胞的破坏力更强。一般来说,细胞的降温速率越慢,发生“溶液损伤”的概率越大,降温速率越快,越容易诱发“胞内冰损伤”。因此,在肿瘤冷冻消融手术过程中普遍追求更快的降温速率,这样对肿瘤的杀伤更彻底,且可以大幅节省手术时间。
冷冻消融技术的发展经历了三个阶段,第一阶段为液氮输送制冷技术,该技术是将-196℃的液氮通过较低的驱动压输送至冷冻消融针的针头来达到冷冻消融的目的,由于该技术的冷源完全依靠液氮,而液氮位于主机或液氮桶内,其距离针头有很长的输送距离,液氮在输送过程中,只有当整个输送管路都达到-196℃以后,针头的温度才能达到-196℃,因此,液氮制冷的降温速率是现有技术中最慢的;第二阶段为直接节流制冷技术,这类技术利用了“焦耳汤姆逊效应”(Joule Thompson Effect,简称J-T)的原理,将常温的超高压气体输送至冷冻消融针内部的J-T槽(产生J-T效应的毛细管)直接节流产生低温,其降温速率是目前技术中相对最快的,但其针头内部的J-T槽和翅片管等结构仍会消耗一部分冷量从而延缓了降温时间,此外,其所使用的超 高压气体普及性不高且价格昂贵,导致该技术推广困难;第三阶段为经预冷的节流制冷技术,其原理是将常温的常规工业气体经过配套主机的预冷后,再输送至冷冻消融针内部的J-T槽通过节流产生比预冷温度更低的消融温度,该技术解决了气源昂贵稀缺的问题,且由于结合了节流制冷技术,其降温速率要明显快于液氮制冷技术,但相对于直接节流的制冷技术,其降温速率仍然偏慢。
发明内容
本发明针对上述现有技术中存在的问题,提出一种J-T槽套管的冷冻消融针,以解决现有技术中降温速率慢的问题。
为解决上述技术问题,本发明是通过如下技术方案实现的:
本发明提供一种J-T槽套管的冷冻消融针,其包括:真空壁、J-T槽以及J-T槽套管;其中,
所述真空壁包括:针杆以及内管;
所述针杆的远端具有针头;
所述内管穿设于所述针杆,所述内管与所述针杆之间形成了夹层,所述夹层为能够形成真空的夹层;
沿所述真空壁的轴心方向,所述内管的远端与所述针杆的远端之间具有第一预设距离;所述内管的远端为所述内管靠近所述针头的一端;
所述J-T槽套管外套于所述J-T槽的远端或内套于所述J-T槽的远端;所述J-T槽的远端为所述J-T槽靠近所述针头的一端;
所述J-T槽以及所述J-T槽套管穿设于所述内管;
在所述真空壁沿其轴心方向分布的各段区域中,所述夹层所处的一段区域为真空隔热区,所述第一预设距离所处的一段区域为靶向区;
所述J-T槽的远端位于所述真空隔热区;
所述J-T槽套管能够沿所述真空壁的轴心方向相对于所述J-T槽运动,所述J-T槽套管与所述J-T槽之间形成动态密封;
所述J-T槽套管的远端能够相对于所述真空壁在至少两个调节位置之间切换,所述至少两个调节位置包括:第一调节位置以及第二调节位置;
所述第一调节位置位于所述靶向区内;
所述第二调节位置位于所述真空隔热区内;
当所述J-T槽套管的远端位于所述第一调节位置时,沿所述真空壁的轴心方向,所述J-T槽套管的远端与所述针头之间具有第二预设距离,所述第二预设距离至少保证冷冻形成的冰球覆盖所述针头;
当所述J-T槽套管的远端位于所述第二调节位置时,沿所述真空壁的轴心方向,所述J-T槽套管的远端与所述真空隔热区的远端之间具有第三预设距离,所述第三预设距离至少保证冷媒从所述J-T槽套管喷出后直接从所述真空隔热区内返回;所述真空隔热区的远端为所述真空隔热区靠近所述针头的一端。
较佳地,还包括:J-T槽套管调节装置,所述J-T槽套管调节装置用于使所述J-T槽套管的远端在所述至少两个调节位置之间切换。
较佳地,所述J-T槽套管调节装置包括:推管以及芯轴;其中,
所述芯轴沿所述真空壁的轴心方向设置;
所述推管穿设于所述芯轴;
所述推管的远端与所述J-T槽套管的近端相连;所述推管的远端为所述推管靠近所述针头的一端;
所述推管、所述J-T槽套管能够受控同步沿所述轴心方向运动,以切换所述J-T槽套管的远端的调节位置。
较佳地,还包括:密封组件,所述密封组件用于使所述芯轴与所述推管之间形成动态密封。
较佳地,所述密封组件包括:密封圈、密封槽以及密封压件;其中,
所述密封槽与所述芯轴的近端固定密封;
所述密封圈设置于所述芯轴与所述密封槽之间,所述密封压件设置于所述密封圈与所述密封槽之间;
所述密封压件能够受控径向挤压,进而使所述密封圈径向挤压所述芯轴,以使所述芯轴与所述推管之间形成动态密封。
较佳地,还包括:弹簧以及卡位件;其中,
所述弹簧的一端能够与所述J-T槽套管的远端同步运动,还与所述卡位件相连;所述卡位件能够进入与脱离卡位位置;
所述弹簧的另一端相对于所述真空壁固定;
当所述卡位件处于卡位位置时,所述弹簧被所述卡位件限位而保持形变 状态,所述J-T槽套管的远端位于所述第二调节位置;
所述形变状态为压缩状态或拉伸状态;
当所述卡位件脱离所述卡位位置时,所述弹簧能够产生自所述形变状态恢复为自然状态的恢复作用力,所述恢复作用力能够驱动所述J-T槽套管的远端自所述第二调节位置进入所述第一调节位置。
较佳地,所述卡位件包括:定位销以及C形环;其中,
所述定位销设置于所述C形环上;
所述C形环包覆在与所述真空壁的相对位置固定的外壁上;
当所述J-T槽套管的远端位于所述第一调节位置时,所述定位销用于使所述弹簧保持所述形变状态。
较佳地,还包括:滑块以及手柄;其中,
所述手柄设置于所述真空壁的近端,所述手柄相对于所述真空壁位置固定;所述真空壁的近端为所述真空壁远离所述针头的一端;
所述滑块与所述推管的近端相连,所述滑块还与所述卡位件直接或间接相连;所述推管的近端为所述推管远离所述针头的一端;
所述滑块、所述推管、所述J-T槽套管能够受控同步沿所述轴心方向运动,以切换所述J-T槽套管的远端的调节位置;
所述手柄上设置有手柄定位槽,所述滑块上设置有滑块定位槽;
所述定位销能够受控同时插入所述滑块定位槽、所述手柄定位槽,进而使所述滑块与所述手柄、所述真空壁位置相对固定,此时所述J-T槽套管的远端位于所述第二调节位置。
较佳地,所述真空壁还包括:外管;其中,
所述外管的远端与所述针杆的近端密封连接,所述外管的近端与所述内管的近端密封连接;所述外管的远端为所述外管靠近所述针头的一端,所述外管的近端为所述外管远离所述针头的一端;
所述外管的外径大于所述针杆的外径,所述外管的内径大于所述针杆的内径;
从所述内管的远端到近端,所述内管依次包括:内管前段以及内管后段,所述内管后段的外径大于所述内管前段的外径,所述内管外端的内径大于所述内管前段的内径;
所述内管前段穿设于所述针杆,所述内管后段穿设于所述外管。
较佳地,所述J-T槽套管与所述J-T槽之间的动态密封点位于所述J-T槽套管的近端;
所述动态密封点位于所述内管后段的内部。
较佳地,还包括:测温线;
所述测温线的远端为测温点;所述测温线的远端为所述测温线靠近所述针头的一端;
所述测温点设于所述J-T槽套管的远端,用于测量所述J-T槽套管的远端处的温度。
相较于现有技术,本发明具有以下优点:
(1)本发明提供的J-T槽套管的冷冻消融针,通过在J-T槽上套设J-T槽套管,J-T槽套管可相对于J-T槽轴向移动,当J-T槽套管的远端位于真空隔热区内部,在J-T槽中通入冷媒流体开启冷冻,可以将主机端以及冷冻消融针端的所有输送管路进行预吹扫(冷却),且该预吹扫过程不会在靶向区段消耗冷量,因此,所有的冷量均被用于冷却输送管路,因此该冷却输送管路过程的速率最快;并且预吹扫过程中靶向区不释放任何冷量,因此,靶向区不会有任何结霜、结冰现象,进而可以直接进行正式手术;
(2)本发明提供的J-T槽套管的冷冻消融针,经过预吹扫后的冷冻消融针仅真空壁的靶向区未被冷却,当J-T槽套管的远端位于靶向区,在J-T槽中通入冷媒流体开启冷冻,所有的热负荷只来自于靶向区和靶向区外的肿瘤组织,因此,该冷冻过程的降温速率会大大加快;
(3)本发明提供的J-T槽套管的冷冻消融针,在试针流程结束后,可以保持预吹扫模式开启,真空隔热区内部(J-T槽套管的远端)保持在最低温,由于靶向区未释放任何冷量,因此,可以进行穿刺、扫描定位等操作,等穿刺到位后,再调节至冷冻模式,此时,靶向区内部将直接从常温瞬间降低至最低温,因此可以实现正式手术环节的极限快速降温;
(4)本发明提供的J-T槽套管的冷冻消融针,适用范围广,可以适用于当前所有的冷冻消融技术:液氮输送制冷技术、直接节流制冷技术、经预冷的节流制冷技术;不仅适用于经皮穿刺冷冻消融器械,还适用于经自然腔道手术的冷冻消融器械。
当然,实施本发明的任一产品并不一定需要同时达到以上所述的所有优点。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本发明的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动性的前提下,还可以根据这些附图获得其他的附图。
图1为本发明一实施例的J-T槽套管的硬质冷冻消融针的J-T槽调节原理图;
图2为本发明一实施例的J-T槽套管的柔性冷冻消融针的J-T槽调节原理图;
图3为本发明一较佳实施例的J-T槽套管的硬质冷冻消融针的预吹扫模式图;
图4为图3中的I部分的放大图;
图5为本发明一较佳实施例的J-T槽套管的硬质冷冻消融针的冷冻模式图;
图6为图5中的II部分的放大图;
图7为本发明一较佳实施例的J-T槽套管的柔性冷冻消融针的真空壁的示意图;
图8为本发明一较佳实施例的J-T槽套管的柔性冷冻消融针的预吹扫模式图;
图9为本发明一较佳实施例的J-T槽套管的柔性冷冻消融针的冷冻模式图;
图10为本发明一较佳实施例的J-T槽套管的柔性冷冻消融针的核心调节机构图;
图11为本发明一较佳实施例的滑块的示意图;
图12为本发明一较佳实施例的卡环的示意图。
附图标记说明:1-J-T槽,
2-真空壁,
21-针杆,
211-针头;
22-内管,
221-内管前段,
222-内管后段,
23-外管,
24-垫圈,
25-靶向区,
26-真空隔热区,
27-弹簧挡板;
28-真空三通,
281-三通连接部,
282-三通旁支;
291-真空连接管,
292-真空软管,
293-回气连接管,
294-分流管;
3-芯轴,
4-翅片管,
5-密封组件,
51-密封圈,
52-密封槽,
53-密封压件;
6-进气管,
7-回气管,
8-滑块,
81-引导管,
82-滑块定位槽,
83-中间固定孔,
84-进回气管引导孔;
9-手柄,
91-手柄定位槽,
10-卡位件,
101-手持部,
102-定位销,
103-C形环;
120-弹簧,
13-外套管,
14-测温线,
141-测温点;
17-推管,
173-测温槽口,
174-进气槽口,
175-推管连接段;
18-J-T槽套管,
181-套管主段,
182-套管密封段,
183-套管连接段;
19-密封垫。
具体实施方式
下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
在本发明说明书的描述中,需要理解的是,术语“上部”、“下部”、“上端”、“下端”、“下表面”、“上表面”等指示的方位或位置关系为基于附图所示的方位或位置关系,仅是为了便于描述本发明和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本发明的限制。
在本发明说明书的描述中,术语“第一”、“第二”仅用于描述目的, 而不能理解为指示或暗示相对重要性或隐含指明所指示的技术特征的数量。由此,限定有“第一”、“第二”的特征可以明示或者隐含地包括一个或者更多个该特征。
在本发明的描述中,“多个”的含义是多个,例如两个,三个,四个等,除非另有明确具体的限定。
下面以具体地实施例对本发明的技术方案进行详细说明。下面这几个具体的实施例可以相互结合,对于相同或相似的概念或过程可能在某些实施例不再赘述。
如图1、图2所示为本发明一实施例的J-T槽位置可调的冷冻消融针的J-T槽调节原理图。
请参考图1、图2,本实施例的J-T槽位置可调的冷冻消融针包括:真空壁2、J-T槽1以及J-T槽套管18;
真空壁2包括:针杆21以及内管22,针杆21的远端具有针头211。内管22穿设于针杆21,内管22与针杆21之间形成夹层,夹层为能够形成真空的夹层,可以为永久真空的夹层或实时抽真空的夹层;真空的夹层起到隔热、防止冻伤正常组织的作用。
内管22的远端与针杆的远端之间具有第一预设距离(该第一预设距离可理解为沿真空壁轴心方向的间隔距离);内管22的远端为内管22靠近针头211的一端。
在真空壁沿其轴心方向分布的各段区域中,因真空的夹层可起到隔热的作用,所以夹层所处的一段区域为真空隔热区26,第一预设距离所处的一段区域为靶向区25。
J-T槽套管18外套于J-T槽1的远端或内套于J-T槽1的远端;J-T槽1的远端为J-T槽1靠近针头211的一端。J-T槽1以及J-T槽套管18穿设于内管22。
图1、图2中,J-T槽套管18外套于J-T槽1的远端。不同实施例中,J-T槽套管18也可内套于J-T槽1的远端。
J-T槽套管18能够沿真空壁的轴心方向相对于J-T槽1运动,J-T槽套管18与J-T槽1之间形成动态密封。
J-T槽套管的远端能够相对于真空壁在至少两个调节位置之间切换(例如 可通过沿真空壁轴心方向的运动实现切换),至少两个调节位置包括:第一调节位置以及第二调节位置。当J-T槽套管18的远端位于第一调节位置时,J-T槽套管18的远端位于靶向区25内,可理解为处于冷冻模式,如图1、2中的虚线部分所示;J-T槽1的远端为J-T槽1靠近针头211的一端。当J-T槽套管18的远端位于第二调节位置时,J-T槽套管18的远端位于真空隔热区26内,可理解为处于预吹扫模式,如图1、2中的实线部分所示。
当J-T槽套管18的远端位于第一调节位置时,沿真空壁的轴心方向,J-T槽套管18的远端离针头有第二预设距离,第二预设距离至少保证冷冻形成的冰球覆盖针头,即冷媒流体从J-T槽套管喷出后从靶向区内部和真空隔热区内部返回,其中冷媒流体从靶向区的内部返回过程中,与整个靶向区外部的物质发生热交换。
当J-T槽套管18的远端位于第二调节位置时,沿真空壁的轴心方向,J-T槽套管18的远端离真空隔热区的远端有第三预设距离,第三预设距离至少保证冷媒媒体从J-T槽套管喷出后直接从真空隔热区内返回,靶向区内只存在相对静止的冷媒,不会与靶向区外的物质发生热交换,即冷冻过程中冷媒在靶向区段不释放任何冷量;真空隔热区的远端为真空隔热区靠近所述针头的一端。
其中的第一预设距离、第二预设距离与第三预设距离,可理解为是沿真空壁2轴心方向的间隔距离。此外,后文中所提及的轴向,均可理解为真空壁2的轴心方向。
一实施例中,真空壁为硬质材料真空壁,可以应用于经皮刺冷冻消融器械,如图1所示,针头211为针尖形式。
一实施例中,真空壁为柔性材料真空壁,可以应用于经自然腔道消融器械,如图2所示,针头211为圆弧形式。优选地,针杆21以及内管22可以为软质的非金属材料或可自由弯曲的金属材料,如:PTFE或PTFE编织管或不锈钢波纹管。
一实施例中,上述双J-T槽的冷冻消融针的使用过程为:手术前,取出处于预吹扫模式的冷冻消融针,与主机相互连接,将冷冻消融针的针杆21(至少靶向区25)插入生理盐水中,开启试刀功能,试刀先执行复温环节,当针头温度在一定时间内上升至某一温度值时,证明复温功能正常。紧接着,程 序自动执行冷冻环节,当针头温度在一定时间内降低至某一温度值时,证明冷冻功能正常,此时可适当延长针头保持最低温的时间以充分预吹扫,然后自动停止试刀。冷冻环节时,可观察真空隔热区26是否有结霜现象,若没有,证明绝热功能正常,全程观察浸于生理盐水中的针头是否有漏气现象,若没有,证明气密性正常。试刀结束后,主机和冷冻消融针的输送管路都完成了预吹扫(冷却)。紧接着,可以先开启冷冻功能(或开启单独设置的预吹扫功能),该阶段的冷冻可以在较低的工作压力下进行,或者间断通气,这样可以使J-T槽的远端的温度维持在最低温的同时还能节省气体用量。接下来,在保持冷冻功能开启的状态下,可在影像学引导下经皮穿刺,使针头到达预期的肿瘤位置。此时,可以调节J-T槽的向远端移动,在第一调节位置停住,切换至冷冻模式。由于整个输送管路已处于低温状态,冷冻消融针的降温热负荷只剩下靶向区25及其外部的肿瘤组织,因此,在切换至冷冻模式后J-T槽的远端的温度,仍能维持在最低温,而靶向区25的外壁将从常温瞬间降至-100℃以下。这样一来,缩短了消融同样大小的肿瘤的手术时间,或在相同时间内生成了更大的消融范围(冰球),此外,由于肿瘤组织被更快速的降温,肿瘤细胞发生胞内冰损伤的概率大幅增加,继而肿瘤细胞的冷冻损伤更加彻底,消融效果更好。
一较佳实施例中,还包括:J-T槽套管调节装置,J-T槽套管调节装置用于使J-T槽套管的远端在至少两个调节位置之间切换。
一实施例中,J-T槽套管调节装置包括:推管17以及芯轴3,请参考图3、5、8、9。其中,芯轴3沿真空壁2的轴心方向设置;推管17穿设于芯轴3。推管17的远端与J-T槽套管18的近端相连;推管17的远端为推管17靠近针头211的一端。推管17、J-T槽套管18能够受控同步沿轴心方向运动,以切换J-T槽套管18的远端的调节位置。
一实施例中,还包括:密封组件5,密封组件5用于使芯轴3与推管17形成动态密封。
一实施例中,密封组件5包括:密封圈51、密封槽52以及密封压件53,请参考图3、5、8、9。其中,密封圈51放置于密封槽52中,密封压件53沿轴向拧入密封槽52中,将密封圈51固定在密封槽52和密封压件53之间,芯轴3插入密封圈51内和密封压件53内,于是,密封圈51在芯轴3和密封 槽52之间发生径向挤压形变,形成动态密封。可选地,密封圈51可以是橡胶密封圈,如丁晴O型圈,也可以是耐低温的氟聚合物+金属弹簧的泛塞密封圈。
一较佳实施例中,柔性冷冻消融针的真空壁还可包括:真空三通28、真空连接管291、真空软管292以及回气连接管293,请参考图7。其中,内管22的近端与回气连接管27的远端连接密封,外管23的近端与三通连接部281连接密封,真空三通28的近端与回气连接管27连接密封,真空连接管291的远端插入三通旁支282,真空软管292插入真空连接管291,通过对真空软管292的近端抽真空,可使内管22和外管23之间的间隙保持真空状态,起到防止冻伤正常自然腔道壁的效果。
一实施例中,还包括:分流管294,用于对进气管6、回气管7以及芯轴3之间的缝隙进行密封;进气管6、回气管7以及芯轴3插入分流管294的近端进行密封,请参考图8、9。
一实施例中,J-T槽套管位置的调节可以通过手动前后调节,也可以通过预制的弹簧120来实现,还包括:卡位件10。其中,弹簧120的一端能够与推管17的远端同步运动,还与卡位件10相连;卡位件10能够进入与脱离卡位位置。弹簧120的另一端相对于真空壁固定。当卡位件10处于卡位位置时,弹簧120被卡位件10限位而保持形变状态,J-T槽套管18的远端位于第一调节位置,请参考图3、8。当卡位件10脱离卡位位置时,弹簧120能够产生自形变状态恢复为自然状态的恢复作用力,恢复作用力能够驱动推管17运动,进而带动J-T槽套管18自第一调节位置进入第二调节位置,请参考图5、9。
一实施例中,弹簧120的远端与真空壁的相对位置不变,弹簧120的近端与卡位件10相连,J-T槽套管18位于第一调节位置时,弹簧120的形变状态为拉伸状态,请参考图3。卡位件10脱离卡位位置时,弹簧120的恢复作用力(拉力)驱动推管向远端运动,进而带动J-T槽套管18自第一调节位置进入第二调节位置,请参考图5。
不同实施例中,也可以设置为弹簧120的近端与真空壁的相对位置不变,弹簧120的远端与卡位件10相连,卡位件10处于卡位位置时,弹簧120被卡位件10限位保持压缩状态,J-T槽套管18位于第一调节位置,请参考图8。卡位件10脱离卡位位置时,弹簧120的恢复作用力(弹力)驱动推管17向 远端运动,进而带动J-T槽套管18自第一调节位置进入第二调节位置,请参考图9。
一实施例中,卡位件10包括:定位销102,如图3、8所示。
一实施例中,还包括:滑块8以及手柄9,请参考图3、5、8、9。手柄9设置于冷冻消融针的近端,与真空壁的相对位置固定,方便抓握。滑块8与推管17的近端相连,且滑块8与卡位件10直接或间接相连。滑块8、推管17、J-T槽套管18能够受控同步沿轴心方向运动,以切换J-T槽套管18的远端的调节位置。滑块8包括:引导管81,引导管81沿真空壁的轴心方向设置。引导管81上设置有中间固定孔83,推管17的远端与中间固定孔83固定。手柄9上设置有手柄定位槽91,滑块8上设置有滑块定位槽82。当J-T槽的远端位于第一调节位置时,定位销102同时插入手柄定位槽91以及滑块定位槽82,从而将滑块8与手柄9的相对位置固定,也就是保持住当前的预吹扫模式。当需要切换至冷冻模式时,只需将定位销102从手柄定位槽91以及滑块定位槽82中拔出即可。
一实施例中,滑块8还包括:设置在引导管81上的进回气管引导孔84。进气管6、回气管7从进回气管引导管84中穿过,请参考11。
较佳实施例中,为了方便卡位件的固定以及方便卡位件的插拔调节,卡位件10还包括:手持部101以及C形环103,请参考图12。其中,手持部101以及定位销102设置在C形环103上;C形环103包覆在手柄9的外壁上,可以防止卡位件径向脱落。
不同实施例中,当不包括手柄9时,C形环103只需包覆在与真空壁的相对位置固定的外壁上,也可达到防止卡位件径向脱落的目的。
较佳实施例中,还包括:弹簧挡板27;弹簧挡板27与真空壁的相对位置固定。请参考图3、5,弹簧120的远端与弹簧挡板27相连,弹簧120的近端与滑块8的引导管81相连,弹簧通过驱动滑块,进而驱动推管运动。
一较佳实施例中,为了提高散热功能,还包括:翅片管4,翅片管4设置于芯轴3的外壁上。翅片管4的近端与进气管6密封连接,翅片管4的远端与J-T槽1的近端密封连接。请参考图10,J-T槽1的近端从进气槽口174一女户然后插入翅片管4的远端进行连接密封。
一实施例中,真空壁2还包括:外管23,请参考图3、6、9、12。外管 23的远端与针杆21的近端密封连接,外管23的近端与内管22的近端密封连接。
一较佳实施例中,为了扩大内管的近端的内部容积,如:可以将翅片管4塞入内管的近端内部,或者可以容纳其他更多的部件;由于内管的近端的内部容积需要扩大,进而真空壁的近端的内部容积也需要扩大。外管23的外径大于针杆21的外径,外管23的内径大于针杆21的内径,外管23的远端为外管23靠近针头211的一端,外管23的近端为外管23远离针头211的一端。进一步地,从内管22的远端到近端,内管22依次包括:内管前段221以及内管后段222,内管后段222的外径大于内管前段221的外径,内管后段222的内径大于内管前段221的内径。内管前段221位于针杆21的内部,内管后段222位于外管23的内部,J-T槽套管与J-T槽之间的动态密封点设置在内管后段222中,请参考图3、5、8、9。
一实施例中,还包括:垫圈24,请参考图3、5。垫圈24设置于内管22的远端外壁与针杆21的内壁之间,形成密封连接。
一实施例中,J-T槽套管18包括:套管主段181、套管密封段182以及套管连接段183。从J-T槽的远端到近端,套管主段181、套管密封段182、套管连接段183依次分布,请参考图4、6。套管主段181的内径稍大于J-T槽1的外径,套管密封段182和J-T槽1之间放置有密封垫19,通过径向挤压套管密封段182将J-T槽套管18和J-T槽1的间隙形成动态密封,密封垫19优选PTFE材料,套管密封段182优选位于内管后段222的远端内部,以使其对回气的影响降至最低。套管连接段183也通过径向挤压来减小外径,套管连接段183插入推管17的推管连接段175并固定。
不同实施例中,J-T套管18与J-T槽1之间的动态密封也可以通过泛塞密封圈来实现。
一较佳实施例中,为了更好地检测冷冻消融针的冷冻效果,还包括:测温线14,测温线14的远端为测温点141,测温线141的远端为测温线141靠近针头211的一端,请参考图3、5、8、9。测温点141设于J-T槽套管18的远端,用于测量J-T槽套管18的远端处的温度。当J-T槽套管18的远端位于靶向区内时,用于在冷冻复温过程中,监测肿瘤中心温度,当J-T槽套管18的远端位于真空隔热区内时,用于在预吹扫过程中通过该温度指示预吹扫是 否到位。测温线14沿着J-T槽套管18的外侧,然后从芯轴3或推管17内部引出至外部,芯轴3或推管17内部通过灌胶水密封。请参考图10,可以从测温槽口173引入推管17的内部,推管内部(测温槽口173的激怒单至推管17的近端这一段)灌胶水进行密封。优选地,还包含复温线,复温线的位置和排布方式于测温线一致,用于实现复温功能。优选低,测温线和/或复温线采用T型漆包热电偶线。
一实施例中,为了将进气管、回气管等部件包裹起来,使得冷冻消融针的外观更整洁、操作更方便,在手柄9的外壁上还设置有外套管13,请参考图3、5、8、9。
较佳实施例中,可将预吹扫模式,即J-T槽套管的远端位于真空隔热区26设置为产品出厂状态,操作者可直接通过试刀的流程完成产品的预吹扫。试刀/预吹扫完成后,再调节至冷冻模式,即J-T槽套管的远端位于靶向区25,开启冷冻后消融针由于经历过预吹扫,靶向区25将会快速降温至最低温度。
在本说明书的描述中,参考术语“一种实施方式”、“一种实施例”、“具体实施过程”、“一种举例”等的描述意指结合该实施例或示例描述的具体特征、结构、材料或者特点包含于本发明的至少一个实施例或示例中。在本说明书中,对上述术语的示意性表述不一定指的是相同的实施例或示例。而且,描述的具体特征、结构、材料或者特点可以在任何的一个或多个实施例或示例中以合适的方式结合。
最后应说明的是:以上各实施例仅用以说明本发明的技术方案,而非对其限制;尽管参照前述各实施例对本发明进行了详细的说明,本领域的普通技术人员应当理解:其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分或者全部技术特征进行等同替换;而这些修改或者替换,并不使相应技术方案的本质脱离本发明各实施例技术方案的范围。

Claims (11)

  1. 一种J-T槽套管的冷冻消融针,其特征在于,包括:真空壁、J-T槽以及J-T槽套管;其中,
    所述真空壁包括:针杆以及内管;
    所述针杆的远端具有针头;
    所述内管穿设于所述针杆,所述内管与所述针杆之间形成了夹层,所述夹层为能够形成真空的夹层;
    沿所述真空壁的轴心方向,所述内管的远端与所述针杆的远端之间具有第一预设距离;所述内管的远端为所述内管靠近所述针头的一端;
    所述J-T槽套管外套于所述J-T槽的远端;所述J-T槽的远端为所述J-T槽靠近所述针头的一端;
    所述J-T槽以及所述J-T槽套管穿设于所述内管;
    在所述真空壁沿其轴心方向分布的各段区域中,所述夹层所处的一段区域为真空隔热区,所述第一预设距离所处的一段区域为靶向区;
    所述J-T槽的远端位于所述真空隔热区;
    所述J-T槽套管能够沿所述真空壁的轴心方向相对于所述J-T槽运动,所述J-T槽套管与所述J-T槽之间形成动态密封;
    所述J-T槽套管的远端能够相对于所述真空壁在至少两个调节位置之间切换,所述至少两个调节位置包括:第一调节位置以及第二调节位置;
    所述第一调节位置位于所述靶向区内;
    所述第二调节位置位于所述真空隔热区内;
    当所述J-T槽套管的远端位于所述第一调节位置时,沿所述真空壁的轴心方向,所述J-T槽套管的远端与所述针头之间具有第二预设距离,所述第二预设距离至少保证冷冻形成的冰球覆盖所述针头;
    当所述J-T槽套管的远端位于所述第二调节位置时,沿所述真空壁的轴心方向,所述J-T槽套管的远端与所述真空隔热区的远端之间具有第三预设距离,所述第三预设距离至少保证冷媒从所述J-T槽套管喷出后直接从所述真空隔热区内返回;所述真空隔热区的远端为所述真空隔热区靠近所述针头的一端。
  2. 根据权利要求1所述的J-T槽套管的冷冻消融针,其特征在于,还包括:J-T槽套管调节装置,所述J-T槽套管调节装置用于使所述J-T槽套管的 远端在所述至少两个调节位置之间切换。
  3. 根据权利要求2所述的J-T槽套管的冷冻消融针,其特征在于,所述J-T槽套管调节装置包括:推管以及芯轴;其中,
    所述芯轴沿所述真空壁的轴心方向设置;
    所述推管穿设于所述芯轴;
    所述推管的远端与所述J-T槽套管的近端相连;所述推管的远端为所述推管靠近所述针头的一端;
    所述推管、所述J-T槽套管能够受控同步沿所述轴心方向运动,以切换所述J-T槽套管的远端的调节位置。
  4. 根据权利要求3所述的J-T槽套管的冷冻消融针,其特征在于,还包括:密封组件,所述密封组件用于使所述芯轴与所述推管之间形成动态密封。
  5. 根据权利要求4所述的J-T槽套管的冷冻消融针,其特征在于,所述密封组件包括:密封圈、密封槽以及密封压件;其中,
    所述密封槽与所述芯轴的近端固定密封;
    所述密封圈设置于所述芯轴与所述密封槽之间,所述密封压件设置于所述密封圈与所述密封槽之间;
    所述密封压件能够受控径向挤压,进而使所述密封圈径向挤压所述芯轴,以使所述芯轴与所述推管之间形成动态密封。
  6. 根据权利要求4所述的J-T槽套管的冷冻消融针,其特征在于,还包括:弹簧以及卡位件;其中,
    所述弹簧的一端能够与所述J-T槽套管的远端同步运动,还与所述卡位件相连;所述卡位件能够进入与脱离卡位位置;
    所述弹簧的另一端相对于所述真空壁固定;
    当所述卡位件处于卡位位置时,所述弹簧被所述卡位件限位而保持形变状态,所述J-T槽套管的远端位于所述第二调节位置;
    所述形变状态为压缩状态或拉伸状态;
    当所述卡位件脱离所述卡位位置时,所述弹簧能够产生自所述形变状态恢复为自然状态的恢复作用力,所述恢复作用力能够驱动所述J-T槽套管的远端自所述第二调节位置进入所述第一调节位置。
  7. 根据权利要求6所述的J-T槽套管的冷冻消融针,其特征在于,所述 卡位件包括:定位销以及C形环;其中,
    所述定位销设置于所述C形环上;
    所述C形环包覆在与所述真空壁的相对位置固定的外壁上;
    当所述J-T槽套管的远端位于所述第一调节位置时,所述定位销用于使所述弹簧保持所述形变状态。
  8. 根据权利要求7所述的J-T槽套管的冷冻消融针,其特征在于,还包括:滑块以及手柄;其中,
    所述手柄设置于所述真空壁的近端,所述手柄相对于所述真空壁位置固定;所述真空壁的近端为所述真空壁远离所述针头的一端;
    所述滑块与所述推管的近端相连,所述滑块还与所述卡位件直接或间接相连;所述推管的近端为所述推管远离所述针头的一端;
    所述滑块、所述推管、所述J-T槽套管能够受控同步沿所述轴心方向运动,以切换所述J-T槽套管的远端的调节位置;
    所述手柄上设置有手柄定位槽,所述滑块上设置有滑块定位槽;
    所述定位销能够受控同时插入所述滑块定位槽、所述手柄定位槽,进而使所述滑块与所述手柄、所述真空壁位置相对固定,此时所述J-T槽套管的远端位于所述第二调节位置。
  9. 根据权利要求1所述的J-T槽套管的冷冻消融针,其特征在于,所述真空壁还包括:外管;其中,
    所述外管的远端与所述针杆的近端密封连接,所述外管的近端与所述内管的近端密封连接;所述外管的远端为所述外管靠近所述针头的一端,所述外管的近端为所述外管远离所述针头的一端;
    所述外管的外径大于所述针杆的外径,所述外管的内径大于所述针杆的内径;
    从所述内管的远端到近端,所述内管依次包括:内管前段以及内管后段,所述内管后段的外径大于所述内管前段的外径,所述内管后段的内径大于所述内管前段的内径;
    所述内管前段穿设于所述针杆,所述内管后段穿设于所述外管。
  10. 根据权利要求9所述的J-T槽套管的冷冻消融针,其特征在于,所述J-T槽套管与所述J-T槽之间的动态密封点位于所述J-T槽套管的近端;
    所述动态密封点位于所述内管后段的内部。
  11. 根据权利要求1至10任一项所述的J-T槽套管的冷冻消融针,其特征在于,还包括:测温线;
    所述测温线的远端为测温点;所述测温线的远端为所述测温线靠近所述针头的一端;
    所述测温点设于所述J-T槽套管的远端,用于测量所述J-T槽套管的远端处的温度。
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