WO2020155301A1 - 耐低温高压的柔性冷冻消融针装置 - Google Patents
耐低温高压的柔性冷冻消融针装置 Download PDFInfo
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- WO2020155301A1 WO2020155301A1 PCT/CN2019/077262 CN2019077262W WO2020155301A1 WO 2020155301 A1 WO2020155301 A1 WO 2020155301A1 CN 2019077262 W CN2019077262 W CN 2019077262W WO 2020155301 A1 WO2020155301 A1 WO 2020155301A1
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- cutter head
- flexible
- pressure relief
- pressure
- tube
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00053—Mechanical features of the instrument of device
- A61B2018/00172—Connectors and adapters therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00577—Ablation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00589—Coagulation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00601—Cutting
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/0063—Sealing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
- A61B2018/0212—Surgical 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 inserted into a body lumen, e.g. catheter
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
- A61B2018/0231—Characteristics of handpieces or probes
- A61B2018/0262—Characteristics of handpieces or probes using a circulating cryogenic fluid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
- A61B2018/0293—Surgical 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 medical field, in particular to a flexible cryoablation needle device resistant to low temperature and high pressure.
- the flexible cold knife is used for biopsy, foreign body extraction, freezing, ablation and inactivation in the natural cavity of the human body (such as the bronchus). It generally contains five major parts, blade head, flexible conduit, handle, extension tube and quick connector.
- the conventional flexible cold knife can be used for biopsy, foreign body extraction, and frozen cutting. It uses carbon dioxide or nitrous oxide as the gas source. Its inlet working pressure is up to 900psi, and the temperature of the knife tip is -40 ⁇ -80°C. Under normal working conditions, the knife head The internal back pressure is generally less than 100 psi.
- the flexible pipe is a single-layer pipe, and since the temperature is not low, heat insulation is not required.
- the flexible cold knife for tumor ablation is a high-pressure and low-temperature treatment device.
- the working pressure of the air inlet is about 1500psi, and the temperature of the knife head can reach -140 ⁇ -170°C. Under normal working conditions, the back pressure in the knife head It is 300 ⁇ 500psi.
- Such a low temperature and high pressure environment requires extremely high connection strength and tightness between the metal cutter head and the plastic flexible pipe. If the connection between the knife head and the flexible tube is broken, the knife head will rush out, pierce human tissues, and cause air leakage, causing additional frostbite or gas embolism.
- the flexible cold knife used for tumor ablation may cause frostbite to the normal cavity wall of the human body because of its low temperature.
- the flexible cold knife in the existing related technology has the following defects: the connection strength and air tightness of the knife head and the flexible pipe are not good, and the pipe burst is prone to occur when the pressure inside the knife head is too high.
- the present invention provides a flexible cryoablation needle device resistant to low temperature and high pressure, to solve the problem that the tube bursts easily when the pressure in the cutter head is too high through automatic pressure relief, and also through the threaded part, the annular protrusion and the first extrusion
- the pressure tube effectively improves the connection strength and air tightness of the flexible conduit and the cutter head.
- a low temperature and high pressure resistant flexible cryoablation needle device comprising: a knife head structure and a flexible tube structure connected to the rear end of the knife head structure, the knife head structure is provided with an inner
- the cutter head structure includes a front section of the cutter head and a rear section of the cutter head.
- the front end of the rear section of the cutter head is connected to the rear end of the front section of the cutter head.
- the outer diameter of the rear section of the cutter head is smaller than that of the cutter head.
- the outer diameter of the front section, the flexible cryoablation needle device further includes: an inner lining tube, a flexible tube structure, a pressure relief component, a pressure relief intermediate cavity, and a first extrusion tube;
- the flexible tube structure is provided with a pressure relief gap And flexible pipe vents, the rear end of the front section of the cutter head is provided with cutter head vents, and the liner pipe is provided with lining vents;
- the front end of the liner tube is connected to the rear end surface of the front section of the cutter head, and the pressure relief intermediate cavity is formed on the inner side of the liner tube and the outer side of the rear section of the cutter head along the radial direction of the cutter head structure In between, the pressure relief intermediate cavity is formed between the rear end surface of the front section of the cutter head and a fixing part along the axial direction of the cutter head structure, and the fixing part is connected to the outer side of the rear section of the cutter head and the Between the inner side of the inner liner tube; the flexible tube structure is arranged on the outer side of the inner liner tube along the radial direction of the cutter head structure, and the pressure relief intermediate cavity is connected to the flexible tube through the inner liner vent hole The vent hole is connected to the pressure relief gap; the inner cavity is connected to one side of the cutter head vent hole, and the pressure relief middle cavity is connected to the other side of the cutter head vent hole;
- At least part of the outer wall of the inner liner tube is attached to the inner wall of the flexible tube structure, and the outer wall of the inner liner tube that is attached to the flexible tube structure is provided with a concave-convex structure;
- the first extruded tube is sleeved Outside the flexible tube structure and on the outside of part of the concave-convex structure;
- the concave-convex structure includes a threaded portion and/or an annular protrusion;
- the pressure relief component is arranged in the pressure relief intermediate cavity, and is used to close the vent hole of the cutter head when the pressure in the cavity is lower than a pressure threshold, and when the pressure in the cavity is higher than or equal to the pressure
- the pressure threshold is set, the cutter head vent hole, the flexible pipe vent hole, and the liner vent hole are all connected, so that the gas in the cutter head structure can sequentially pass through the cutter head vent hole and relieve pressure
- the intermediate cavity, the lining vent hole, the flexible pipe vent hole and the pressure relief gap are exhausted and pressure released.
- the pressure relief assembly includes a slider and a spring located in the pressure relief intermediate cavity, and the spring connects the slider and the fixed portion along the axial direction of the cutter head structure;
- a first sealing component is provided on one side of the rear end of the front section of the head;
- the spring is configured to be able to drive the first sealing member to be clamped by the sliding block and the rear end surface of the front section of the cutter head by elastic force when the pressure of the inner cavity is lower than the pressure threshold to close
- the cutter head vent hole and: when the pressure of the inner cavity is higher than or equal to the pressure threshold, it can be compressed under the drive of the pressure of the inner cavity, so that the cutter head vent hole is no longer Closed
- the closure mentioned above includes both direct closure and indirect closure.
- the indirect closure can be understood as a situation where it is not in circulation but not in direct contact.
- the first sealing component is connected to the front end of the slider; when the first sealing component is clamped by the slider and the rear end surface of the front section of the cutter head, the first sealing component can directly Closed at the vent hole of the cutter head;
- the first sealing component is connected to the rear end surface of the front section of the cutter head, and the first side of the slider along the radial direction of the cutter head structure is provided with an intermediate gap;
- the pressure relief intermediate cavity includes A first pressure relief sub-cavity located on the side of the front end of the slider and a second pressure relief sub-cavity located on the side of the back end of the slider;
- the first sealing member When the first sealing member is clamped by the sliding block and the rear end surface of the front section of the cutter head, the first sealing member can close the front end of the intermediate gap, so that the first pressure relief sub-cavity and The second pressure relief sub-cavity is blocked;
- a second sealing member is provided on the second side of the slider along the radial direction of the cutter head structure, and the second sealing member is used to block the first side of the slider.
- a pressure relief sub-cavity and the second pressure relief sub-cavity are provided on the second side of the slider along the radial direction of the cutter head structure, and the second sealing member is used to block the first side of the slider.
- a groove is provided on the second side of the slider, and the second sealing member is installed in the groove.
- first sealing component and the second sealing component are both sealing rings.
- the flexible pipe structure includes a flexible inner pipe and a flexible outer pipe provided outside the flexible inner pipe
- the flexible outer pipe includes a first outer pipe section connected to the cutter head structure and The second outer pipe section at the rear end of the first outer pipe section, the inner wall of the first outer pipe section is attached to the outer wall of the flexible inner pipe, and the pressure relief gap is formed between the second outer pipe section and the flexible inner pipe
- the flexible tube vent is provided in the flexible inner tube, and the pressure relief gap is connected to the pressure pumping component.
- the flexible inner tube and the flexible outer tube are made of polytetrafluoroethylene.
- the flexible cryoablation needle device further includes a second squeeze tube, and the second squeeze tube is sleeved on the outer side of the flexible inner catheter and located on the outer side of a part of the concave-convex structure.
- the device further includes a pipeline structure, the pipeline structure penetrates the rear section of the cutter head along the axial direction of the cutter head structure, and the pipeline structure is provided with gas to enter the plant.
- a return air passage for the gas in the inner cavity to be discharged to the rear end side of the rear section of the cutter head is formed between the inner side of the rear section of the cutter head and the outer side of the passage structure.
- the low-temperature and high-pressure resistant flexible cryoablation needle device provided by the present invention because the outer wall of the liner tube is provided with a threaded part, can improve the connection strength between the liner tube and the flexible tube structure, because the outer wall of the liner tube
- the annular convex part is provided to ensure that the gas coming over when the pressure is relieved will not leak further outwards, and the connection strength can also be improved.
- the invention can further ensure the air tightness and connection strength through the radial extrusion of the extrusion tube.
- the present invention utilizes the cutter head vent, pressure relief intermediate cavity, lined vent, flexible pipe vent and pressure relief gap to directly relieve the pressure in the inner cavity of the cutter head, wherein the pressure in the inner cavity is higher than When it is equal to the pressure threshold, the realization of pressure relief can be automatically controlled to avoid the occurrence of excessive pressure in the cutter head, thereby avoiding the tube burst.
- the present invention is also different from the solution of directly setting pressure relief related components in the return air passage. If directly set in the return air passage, it can only realize automatic pressure relief when the return air passage is blocked. If blockage occurs in the air channel, it cannot play a positive pressure relief effect. However, based on actual experiments and studies on the clogging phenomenon during use, the present invention found that in actual situations, clogging may occur at any other position, such as the flexible duct of the flexible cold knife, the extension pipe section, etc.; therefore, the present invention Relieve the pressure of the cutter head directly, which can effectively deal with a variety of blockages and can easily deal with the excessive pressure in the cutter head caused by various reasons.
- a double-layered tube structure of a flexible inner tube and a flexible outer tube is used, which can facilitate the realization of heat insulation and prevent the flexible cold knife from damaging the human body due to the low temperature.
- the heat insulation effect can be further improved while the pressure is relieved.
- the optional solution of the present invention adopts tetrafluoroethylene material. Because tetrafluoroethylene material has good mechanical toughness, even The temperature drops to -196°C and the elongation rate of 5% can be maintained. Therefore, polytetrafluoroethylene is used as the material of the inner and outer flexible conduits to achieve safe sealing at low temperatures.
- FIG. 1 is a schematic diagram of the structure of a flexible cryoablation needle device capable of withstanding low temperature and high pressure in an embodiment of the present invention
- FIG. 2 is a schematic structural diagram 1 of a flexible cryoablation needle device resistant to low temperature and high pressure in another embodiment of the present invention
- Fig. 3 is a partial structural diagram 1 of a flexible cryoablation needle device resistant to low temperature and high pressure in another embodiment of the present invention
- Figure 4 is a schematic structural view of the A-A section in Figure 3;
- Fig. 5 is a second partial structural diagram of a flexible cryoablation needle device resistant to low temperature and high pressure in another embodiment of the present invention.
- Fig. 1 is a schematic structural diagram of a flexible cryoablation needle device resistant to low temperature and high pressure in an embodiment of the present invention.
- a flexible cryoablation needle device resistant to low temperature and high pressure comprising: a cutter head structure 1 and a flexible tube structure 2 connected to the rear end of the cutter head structure 1, and the cutter head structure 1 is provided with an inner cavity 14.
- the cutter head structure 1 includes a cutter head front section 11 and a cutter head rear section 12.
- the front end of the cutter head rear section 12 is connected to the rear end of the cutter head front section 11, and the outer diameter of the cutter head rear section 12 is smaller than The outer diameter of the front section 11 of the cutter head
- the flexible cryoablation needle device further includes: an inner lining tube 5, a pressure relief component 4, a pressure relief middle cavity 3 and a first extrusion tube 6.
- the flexible pipe structure 2 is provided with a pressure relief gap 22 and a flexible pipe vent 21, the rear end of the front section 11 of the cutter head is provided with a cutter head vent 13, and the liner tube 5 is provided with an lining vent 51 .
- the front end of the liner tube 5 is connected to the rear end surface of the front section 11 of the cutter head, and the pressure relief intermediate cavity 3 is formed on the inner side of the liner tube 5 and the cutter head along the radial direction of the cutter head structure 1.
- the pressure relief intermediate cavity 3 is formed along the axial direction of the cutter head structure 1 between the rear end surface of the front section 11 of the cutter head and the fixing part 9, and the fixing part 9 is connected
- the flexible pipe structure 2 is arranged on the outer side of the inner liner tube 5 along the radial direction of the cutter head structure 1, the The pressure relief intermediate cavity 3 is connected to the pressure relief gap 22 via the liner vent hole 51 and the flexible pipe vent hole 21;
- the inner cavity 14 is connected to one side of the cutter head vent hole 13, which can It is understood as the left side of the cutter head vent 13 as shown in the figure, and the pressure relief intermediate cavity 3 is connected to the other side of the cutter
- the pressure relief intermediate cavity 3 can be connected to one side of the flexible pipe vent 21 through the lining vent 51, which can be understood as the flexible pipe vent 21 shown in FIG.
- the pressure relief gap 22 is connected to the other side of the flexible pipe vent 21, which can be understood as the upper side of the flexible pipe vent 21 as shown in FIG. 1.
- the flexible pipe vent 21 It can also be understood as being arranged along the radial direction of the cutter head structure 1.
- the two sides of the cutter head vent 13 and the flexible tube vent 21 may not be limited to the radial and axial directions shown in FIG. 1.
- the cutter head vent 13 may be axially or axially.
- the flexible pipe vent 21 and the inner liner vent 51 can be along the radial direction as well as along the axial direction.
- the number of cutter head vents 13, flexible vents 21, and liner vents 51 can be single or multiple. If there are more than one, the plurality of cutter head vents 13 can be structured around the cutter head. 1, the multiple flexible vent holes 21 and the multiple liner vent holes 51 may be distributed around the axial direction of the cutter head structure 1.
- the pressure relief gap 22 may be a ring-shaped gap, or may include a plurality of gap portions, and the gap portions may be distributed around the axial direction of the cutter head structure 1.
- each gap portion can be connected to at least one flexible pipe vent 21.
- the shapes of the vent holes mentioned above can be various, and are not limited to cylindrical hole structures.
- the hole structure can be a shape with a larger end and a smaller end.
- the cross-section of the hole structure is not only circular , It can also be a polygon.
- the pressure relief component 4 is arranged in the pressure relief intermediate cavity 3, and is used to close the cutter head vent 13 when the pressure of the internal cavity 14 is lower than a pressure threshold, and the pressure in the internal cavity 14 is high At or equal to the pressure threshold, the cutter head vent 13 and the flexible pipe vent 21 are controlled to communicate with the liner vent 51, so that the gas in the cutter head structure 1 can pass through sequentially
- the cutter head vent 13, the pressure relief intermediate cavity 3, the liner vent 51, the flexible pipe vent 21 and the pressure relief gap 22 are discharged and relieved of pressure.
- closure can be understood as any means that prevents circulation on both sides of the vent.
- the realized automatic control process can also be adaptively changed, for example: if only the knife is closed when closing If the head vent 13 is not closed, the flexible pipe vent 21 and the liner vent 51 are not closed, the automatic control implemented can be to control the cutter head vent 13 to no longer be closed; another example: if only the flexible pipe vent is closed when closing If the air hole 21 and the lining vent hole 51 are not closed, the automatic control implemented can be to control the flexible pipe vent hole 21 and the lining vent hole not to be closed; for example: If the cutter head vent 13 and the flexible pipe vent 21 are automatically controlled, the automatic control can be to control that the cutter head vent 13 and the flexible pipe vent 21 are no longer closed.
- the above mentioned closures include direct closures and indirect closures. The indirect closures can be understood as making them non-circulating, but not in direct contact.
- the low-temperature and high-pressure resistant flexible cryoablation needle device utilizes the knife head vent, pressure relief intermediate cavity, flexible tube vent and pressure relief gap to directly relieve pressure on the inner cavity of the knife head.
- the pressure of the inner cavity is higher than or equal to the pressure threshold, the realization of pressure relief can be automatically controlled to avoid the occurrence of excessive pressure in the cutter head, thereby avoiding the burst of the catheter.
- this embodiment is also different from the solution of directly setting pressure relief related components in the return air passage. If directly set in the return air passage, it can only realize automatic pressure relief when the return air passage is blocked. If there is a blockage in the air return channel of the knife, it cannot play a positive pressure relief effect.
- this example found that in actual situations, clogging may occur in any other position, such as the flexible duct of the flexible cold knife, the extension pipe section, etc.; therefore, this The embodiment directly relieves the pressure of the cutter head, which can effectively cope with various clogging conditions, and can easily deal with the excessive pressure in the cutter head caused by various reasons.
- FIG. 2 is a schematic diagram 1 of the structure of a flexible cryoablation needle device resistant to low temperature and high pressure in another embodiment of the present invention
- FIG. 3 is a partial structure diagram 1 of a flexible cryoablation needle device resistant to low temperature and high pressure in another embodiment of the present invention
- 4 is a schematic structural diagram of the AA section in FIG. 3
- FIG. 5 is a partial structural schematic diagram 2 of a flexible cryoablation needle device resistant to low temperature and high pressure in another embodiment of the present invention.
- the cutter head structure 1 includes a cutter head front section 11 and a cutter head rear section 12, the front end of the cutter head rear section 12 is connected to the rear end of the cutter head front section 11, the knife
- the outer diameter of the rear section 12 is smaller than the outer diameter of the front section 11 of the cutter head.
- the cutter head vent hole 13 is provided on the rear end surface of the front section 11 of the cutter head and located outside the rear section 12 of the cutter head.
- the pressure relief intermediate cavity 3 is located on the side of the rear end of the front section 11 of the cutter head.
- the size change in the cutter head structure 1 can be adapted to realize the connection with the flexible pipe structure 2 to ensure uniform matching of the overall size.
- the pressure relief assembly 4 includes a slider 41 and a spring 42 located in the pressure relief intermediate cavity 3, and the fixed portion 9 may be a part of the inner liner 5, or can be understood as a fixed portion 9 is integral with the liner tube 5, and the spring 42 connects the slider 41 and the fixing portion 9 along the axial direction of the cutter head structure 1;
- the first sealing member 43 may be formed by being wound around the rear section 12 of the cutter head, and connected to the fixing part 9 and the sliding block 41.
- the spring 42 can be configured to be able to drive the first sealing member 43 by the slider 41 and the rear of the front section 11 of the cutter head through elastic force when the pressure of the inner cavity 14 is lower than the pressure threshold.
- the end faces are clamped to close the air hole 13 of the cutter head.
- the spring 42 can be understood as being compressed, thereby generating the elastic force mentioned above.
- the spring 42 can also be configured to be compressed by the pressure of the inner cavity 14 when the pressure of the inner cavity 14 is higher than or equal to the pressure threshold, so that the cutter head vent 13 No longer being closed. Specifically, when the pressure is lower than the pressure threshold, the spring 42 may be compressed to a certain extent, and when the pressure is higher than or equal to the pressure threshold, the spring 42 may be further compressed.
- the configuration mentioned above can be understood as the adaptation of the deformation capacity and length of the spring 42 and the pressure relief intermediate cavity 3 to meet the above functions.
- the pressure threshold can be understood as any value that can be adjusted according to specific situations, and the value can be adjusted and determined by the selection of the spring 42 and the process of manufacturing, molding, and installation.
- the first sealing member 43 is connected to the front end of the slider 41; when the first sealing member 43 is clamped by the slider 41 and the rear end surface of the front section 11 of the cutter head, The first sealing member 43 can be sealed to the cutter head vent 13; that is, the first sealing member 43 can directly close the cutter head vent 13; the spring 42 is driven by the pressure of the inner cavity 14 When compressed, the first sealing member 43 is separated from the cutter head vent 13 so that the cutter head vent 13 is no longer closed.
- the first sealing member 43 is connected to the rear end surface of the front section 11 of the cutter head, and the first side of the slider 41 along the radial direction of the cutter head structure 1 is provided with an intermediate gap
- the side close to the axis shown in Figures 2 and 3 is provided with an intermediate gap
- the pressure relief intermediate cavity 3 includes a first pressure relief sub-cavity located on the side of the front end of the slider 41 and The second pressure relief sub-cavity on one side of the rear end of the slider 41.
- the sliding block 41 divides the pressure relief intermediate cavity 3 into sub-cavities on both ends in the axial direction.
- the first sealing member 43 When the first sealing member 43 is clamped by the slider 41 and the rear end surface of the front section 11 of the cutter head, the first sealing member 43 can simultaneously close the front end of the intermediate gap, so that the first The pressure relief sub-cavity is separated from the second pressure relief sub-cavity; at this time, the first pressure relief sub-cavity can be understood as the space between the cutter head vent 13 and the front end of the slider 41, which can communicate with the cutter head The air hole 13 communicates with the second pressure relief chamber to form a whole.
- the second side of the slider 41 along the radial direction of the cutter head structure 1 is provided with a second sealing member 44, and the second sealing member 44 is used in the slider 41
- the second side partitions the first pressure relief sub-cavity and the second pressure relief sub-cavity.
- the second side refers to the second side in the radial direction.
- the second side of the slider 41 may be provided with a groove, and the second sealing member 44 may be installed in the groove.
- first sealing member 43 and the second sealing member 44 may be sealing rings.
- the gas in the front section 11 of the cutter head can be prevented from entering the pressure relief gap 22. If the return air is blocked, the internal pressure of the cutter head structure 1 will increase. If the gas pressure is higher than the thrust provided by the spring 42, it will cause the slider 41 to move backward, and the gas will pass through the cutter head vent 13 to the middle of the pressure relief. The cavity 3 enters the pressure relief gap 22. Excessive gas will be discharged quickly by the vacuum suction effect generated by components such as the pressure pumping component to achieve the purpose of pressure relief.
- the rear section 12 of the cutter head can be sequentially sleeved with the first sealing member 43 such as the sealing ring, the slider 41 with the sealing ring 2, and the spring 42, and the partition between the front and rear sections of the cutter head, namely the knife Four cutter head vent holes 13 are opened along the axial direction on the rear end of the front head section 11 for ventilation when pressure is relieved.
- the first sealing member 43 of the seal ring is used for the gap between the rear section 12 of the cutter head and the slider 41.
- Axial sealing for example, the second sealing member 44 of the sealing ring is used for the radial piston seal between the inner liner tube 5 and the slider 41.
- the inner liner tube 5 is sleeved on the rear section 12 of the cutter head.
- the welding point 54 at the front end ensures that the gas in the cutter head structure 1 does not It will leak out of the cutter head structure 1, and the welding point 54 at the rear end ensures that the gas in the inner flexible conduit 23 will not enter the pressure relief gap 22.
- the flexible cryoablation needle device of the present invention further includes an inner liner 5, the front end of the inner liner 5 is connected to the rear end of the front section 11 of the cutter head, and the pressure relief middle cavity 3 is along the cutter head structure 1 is formed in the radial direction between the inner liner tube 5 and the rear section 12 of the cutter head, the inner liner tube 5 is provided with an inner liner vent 51, and the pressure relief intermediate cavity 3 passes through the inner liner
- the air hole 51 communicates with the flexible pipe vent 21 to the pressure relief gap 22, the flexible pipe structure 2 is provided on the outer side of the inner liner 5 along the radial direction of the cutter head structure 1, and the inner At least part of the outer wall of the liner 5 is attached to the inner wall of the flexible pipe structure 2.
- the inner liner 5 can facilitate the formation of the pressure relief intermediate cavity 3.
- the outer wall of the inner liner tube 5 that is attached to the flexible tube structure 2 may be provided with a concave-convex structure, and the concave-convex structure may include a threaded portion 52. Through the threaded portion 52, the connection strength between the inner liner pipe and the flexible pipe structure can be improved.
- the concave-convex structure may further include an annular protrusion 53, that is, the outer wall of the inner liner tube 5 that is attached to the flexible pipe structure 2 may also be provided with an annular protrusion 53.
- the annular protrusion 53 can ensure leakage. The compressed gas will not leak further outward, and the connection strength can also be improved.
- the number of the annular protrusions 53 can be two groups, which are located on both sides of the lining vent 51 along the axial direction of the cutter head structure 1.
- the flexible cryoablation needle device involved in this embodiment further includes a first squeeze tube 6 that is sleeved outside the flexible tube structure 2 and is located outside part of the concave-convex structure.
- the concave-convex structure may include an annular protrusion 53 and a threaded portion 52, for example.
- the concave-convex structure may include, for example, an annular protrusion 53.
- the extruded tube located outside the flexible tube structure 2 can be understood as the first extruded tube 6, and the extruded tube on the inner wall of the pressure relief gap 22 can be understood as the second extruded tube 8.
- the first extruded tube 6 and the second extruded tube 8 are respectively located on both sides of the lining vent 51 and the flexible tube vent 21 along the axial direction of the cutter head structure 1.
- the flexible tube structure 2 includes a flexible inner tube 23 and a flexible outer tube 24 provided outside the flexible inner tube 23, and the flexible outer tube 24 includes a flexible tube connected to the cutter head structure 1.
- the flexible inner tube 23 and the flexible outer tube 24 may be made of polytetrafluoroethylene.
- the catheter made of PTFE material has good toughness even at low temperatures.
- the threaded part, the annular convex part, and the extrusion of the metal cutter head structure and the polytetrafluoroethylene pipe are adopted.
- the threaded part provides the connection strength
- the annular convex part ensures the air tightness
- the metal The cutting head structure and the extrusion of PTFE further strengthen the connection strength and air tightness, while also improving the good toughness.
- the flexible pipe structure 2 is screwed into the threaded portion 52, and the teeth of the threaded portion 52 in the radial direction will be embedded in the wall of the flexible pipe structure 2.
- the wall thickness of the flexible inner conduit 23 in the flexible tube structure 2 is at least not less than 2 times the tooth height, which can be used to prevent the axial pressure from separating the cutter head structure 1 and the flexible tube structure 2 and the embedding of multi-ring teeth
- the axial pressure will be evenly distributed to each ring of teeth, but the embedding of the teeth is not enough, because the flexible tube structure 2 also has a tendency to expand radially outwards, by adding an extruded tube on its outer side.
- the flexible inner tube 23 can be prevented from expanding outward, and the teeth and the flexible tube structure 2 can be fully fitted and contacted. Therefore, the combination of the threaded part and the extruded tube can also ensure the cutter head Structure 1 has sufficient compressive strength.
- the annular protrusion 53 plus the extrusion of the squeeze tube ensures that the gas coming over when the pressure is relieved will not leak to the outside of the cutter head structure 1, and also provides a certain axial connection strength; the annular protrusion 53 adds the extrusion
- the squeezing of the pressure tube ensures that the gas in the flexible inner duct 23 will not enter the pressure relief gap 22.
- the joint action of the two sets of annular protrusions can also prevent the gas in the flexible inner duct 23 from leaking to the outside of the cutter head structure 1.
- the flexible inner duct 23 and the flexible outer duct 24 are squeezed by the squeeze tube to ensure that the gas outside the cutter head structure 1 will not be sucked into the pressure relief gap 22.
- the flexible inner duct 23 has an inner duct air hole in the radial direction
- the flexible outer duct 24 has an outer duct air hole in the radial direction.
- the inner duct air hole and the outer duct air hole can be concentrically aligned to form the aforementioned flexibility. Tube vent.
- threaded connection sealing or thread + glue connection sealing and other means can not meet the requirements of low temperature resistance and high pressure resistance at the same time, because the air tightness of the thread (especially pipe thread) is not high, and a small amount of gas will Leak from the mating clearance of male and female threads. If thread glue is filled in the gap, the air tightness can only be guaranteed at room temperature or appropriate low temperature, because most glues will be brittle and cracked at low temperatures of -140 ⁇ -170 °C, and air tightness cannot be guaranteed.
- the flexible cryoablation needle device further includes a pipeline structure 7 which penetrates the rear section 12 of the cutter head along the axial direction of the cutter head structure 1, and
- the pipeline structure 7 is provided with an inlet channel for gas to enter the inner cavity, and the pipeline structure 7 may be, for example, a JT tank.
- the gas can enter the inner cavity 14 of the front section 11 of the cutter head from the inside of the pipeline structure 7 such as the JT groove, and then pass through the gap between the rear section 12 of the cutter head and the outer side of the pipeline structure 7 such as the JT groove, which is referred to above
- the return air channel returns, and then returns through the inner side of the flexible inner duct 23.
- the low temperature and high pressure resistant flexible cryoablation needle device provided by the present invention, because the outer wall of the liner tube is provided with a threaded part, can improve the connection strength between the liner tube and the flexible tube structure.
- the outer wall of the inner lining pipe is provided with an annular protrusion to ensure that the gas coming over when the pressure is released will not leak further outwards, and at the same time, the connection strength can be improved.
- the present invention can further ensure air tightness and connection strength through the radial extrusion of the extrusion tube.
- the present invention utilizes the cutter head vent, pressure relief intermediate cavity, lined vent, flexible pipe vent and pressure relief gap to directly relieve the pressure in the inner cavity of the cutter head, wherein the pressure in the inner cavity is higher than When it is equal to the pressure threshold, the realization of pressure relief can be automatically controlled to avoid the occurrence of excessive pressure in the cutter head, thereby avoiding the tube burst.
- the present invention is also different from the solution of directly setting pressure relief related components in the return air passage. If directly set in the return air passage, it can only realize automatic pressure relief when the return air passage is blocked. If blockage occurs in the air channel, it cannot play a positive pressure relief effect. However, based on actual experiments and studies on the clogging phenomenon during use, the present invention finds that in actual situations, clogging may occur at any other position, such as the flexible duct of the flexible cold knife, the extension pipe section, etc.; therefore, the present invention Relieve the pressure of the cutter head directly, which can effectively deal with a variety of blockages and can easily deal with the excessive pressure in the cutter head caused by various reasons.
- a double-layered tube structure of a flexible inner tube and a flexible outer tube is used, which can facilitate the realization of heat insulation and prevent the flexible cold knife from damaging the human body due to the low temperature.
- the heat insulation effect can be further improved while the pressure is relieved.
- the optional solution of the present invention adopts tetrafluoroethylene material. Because tetrafluoroethylene material has good mechanical toughness, even The temperature drops to -196°C and the elongation rate of 5% can be maintained. Therefore, polytetrafluoroethylene is used as the material of the inner and outer flexible conduits to achieve safe sealing at low temperatures.
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Abstract
Description
Claims (10)
- 一种耐低温高压的柔性冷冻消融针装置,包括:刀头结构与连接于所述刀头结构后端的柔性管结构,所述刀头结构中设有内腔,所述刀头结构包括刀头前段与刀头后段,所述刀头后段的前端连接于所述刀头前段的后端,所述刀头后段的外径小于所述刀头前段的外径,其特征在于,所述的柔性冷冻消融针装置还包括:内衬管、泄压组件、泄压中间腔与第一挤压管;所述柔性管结构中设有泄压缝隙与柔性管通气孔,所述刀头前段的后端面设有刀头通气孔,所述内衬管设有内衬通气孔;所述内衬管的前端连接所述刀头前段的后端面,所述泄压中间腔沿所述刀头结构的径向形成于所述内衬管的内侧与所述刀头后段的外侧之间,所述泄压中间腔沿所述刀头结构的轴向形成于所述刀头前段的后端面与固定部之间,所述固定部连接于所述刀头后段外侧与所述内衬管的内侧之间;所述柔性管结构沿所述刀头结构的径向设于所述内衬管的外侧,所述泄压中间腔经所述内衬通气孔与所述柔性管通气孔连通至所述泄压缝隙;所述内腔连接于所述刀头通气孔的一侧,所述泄压中间腔连接于所述刀头通气孔的另一侧;所述内衬管的至少部分外壁与所述柔性管结构的内壁贴合,所述内衬管的与所述柔性管结构贴合的外壁设有凹凸结构;所述第一挤压管套设于所述柔性管结构外,且位于部分所述凹凸结构的外侧;所述凹凸结构包括螺纹部和环形凸起部;所述泄压组件设于所述泄压中间腔,用于在所述内腔的压力低于压力阈值时封闭所述刀头通气孔,并在所述内腔的压力高于或等于所述压力阈值时,控制所述刀头通气孔、所述柔性管通气孔与所述内衬通气孔均连通,以使得所述刀头结构中的气体能够依次经所述刀头通气孔、泄压中间腔、所述内衬通气孔、所述柔性管通气孔与所述泄压缝隙被排出泄压。
- 根据权利要求1所述的装置,其特征在于,所述泄压组件包括位于所述泄压中间腔内的滑块与弹簧,所述弹簧沿所述刀头结构的轴向连接所述滑块与所述固定部;所述刀头前段的后端面一侧设有第一密封部件;所述弹簧被配置为在所述内腔的压力低于所述压力阈值时能够通过弹性力驱动所述第一密封部件被所述滑块与所述刀头前段的后端面夹持,以封闭所述刀头通气孔,以及:在所述内腔的压力高于或等于所述压力阈值时能够在所述内腔的压力的驱动下被压缩,以使得所述刀头通气孔不再被封闭。
- 根据权利要求2所述的装置,其特征在于,所述第一密封部件连接所述滑块的前端;所述第一密封部件被所述滑块与所述刀头前段的后端面夹持时,所述第一密封部件能够封闭于所述刀头通气孔;所述弹簧在所述内腔的压力驱动下被压缩时,所述第一密封部件与所述刀头通气孔分离,以使得所述刀头通气孔不再被封闭。
- 根据权利要求2所述的装置,其特征在于,所述第一密封部件连接所述刀头前段的后端面,所述滑块的沿所述刀头结构的径向的第一侧设有中间缝隙;所述泄压中间腔包括位于所述滑块的前端一侧的第一泄压分腔与位于所述滑块的后端一侧的第二泄压分腔;所述第一密封部件被所述滑块与所述刀头前段的后端面夹持时,所述第一密封部件能够封闭所述中间缝隙的前端,以使得所述第一泄压分腔与所述第二泄压分腔被隔断;所述弹簧在所述内腔的压力驱动下被压缩时,所述刀头通气孔、所述第一泄压分腔、所述中间缝隙、所述第二泄压分腔、所述柔性管通气孔,以及所述泄压缝隙依次连通。
- 根据权利要求4所述的装置,其特征在于,所述滑块的沿所述刀头结构的径向的第二侧设有第二密封部件,所述第二密封部件用于在所述滑块的第二侧隔断所述第一泄压分腔与所述第二泄压分腔。
- 根据权利要求5所述的装置,其特征在于,所述滑块的第二侧设有凹槽,所述第二密封部件安装于所述凹槽。
- 根据权利要求1至6任一项所述的装置,其特征在于,所述柔性管结构包括柔性内导管与设于所述柔性内导管外的柔性外导管,所述柔性外导管包括连接于所述刀头结构的第一外管段与连接于所述第一外管段 后端的第二外管段,所述第一外管段的内壁与所述柔性内导管外壁贴合,所述泄压缝隙形成于所述第二外管段与所述柔性内导管之间,所述柔性管通气孔设于所述柔性内导管,所述泄压缝隙连通至抽压组件。
- 根据权利要求7所述的装置,其特征在于,所述柔性内导管与所述柔性外导管为聚四氟乙烯材料的。
- 根据权利要求7所述的装置,其特征在于,还包括第二挤压管,所述第二挤压管套设于所述柔性内导管外侧,且位于部分所述凹凸结构的外侧。
- 根据权利要求1至6任一项所述的装置,其特征在于,还包括管路结构,所述管路结构沿所述刀头结构的轴向穿设于所述刀头后段,所述管路结构内设有供气体进入所述内腔的进入通道,所述刀头后段内侧与所述通道结构外侧间形成有供所述内腔的气体排出至所述刀头后段的后端一侧的回气通道。
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
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EP19914095.5A EP3881786B1 (en) | 2019-01-28 | 2019-03-07 | Flexible cryoablation needle device resistant to low temperature and high pressure |
ES19914095T ES2931468T3 (es) | 2019-01-28 | 2019-03-07 | Dispositivo de aguja de crioablación flexible resistente a bajas temperaturas y alta presión |
JP2021534350A JP7145333B2 (ja) | 2019-01-28 | 2019-03-07 | 耐低温高圧の可撓性冷凍アブレーションニードル装置 |
US17/311,802 US11986230B2 (en) | 2019-01-28 | 2019-03-07 | Flexible cryoablation needle device resistant to low temperature and high pressure |
KR1020217008155A KR102548744B1 (ko) | 2019-01-28 | 2019-03-07 | 내저온 및 내고압 연성 냉동 절제 니들 장치 |
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CN201910077358.7 | 2019-01-28 | ||
CN201910077358.7A CN109431595B (zh) | 2019-01-28 | 2019-01-28 | 耐低温高压的柔性冷冻消融针装置 |
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US (1) | US11986230B2 (zh) |
EP (1) | EP3881786B1 (zh) |
JP (1) | JP7145333B2 (zh) |
KR (1) | KR102548744B1 (zh) |
CN (1) | CN109431595B (zh) |
ES (1) | ES2931468T3 (zh) |
WO (1) | WO2020155301A1 (zh) |
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CN110478027A (zh) * | 2019-08-13 | 2019-11-22 | 上海导向医疗系统有限公司 | 一种可调靶向区的冷冻消融针 |
US11633224B2 (en) | 2020-02-10 | 2023-04-25 | Icecure Medical Ltd. | Cryogen pump |
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- 2019-01-28 CN CN201910077358.7A patent/CN109431595B/zh active Active
- 2019-03-07 US US17/311,802 patent/US11986230B2/en active Active
- 2019-03-07 JP JP2021534350A patent/JP7145333B2/ja active Active
- 2019-03-07 WO PCT/CN2019/077262 patent/WO2020155301A1/zh unknown
- 2019-03-07 EP EP19914095.5A patent/EP3881786B1/en active Active
- 2019-03-07 KR KR1020217008155A patent/KR102548744B1/ko active IP Right Grant
- 2019-03-07 ES ES19914095T patent/ES2931468T3/es active Active
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Publication number | Publication date |
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KR20210049126A (ko) | 2021-05-04 |
CN109431595A (zh) | 2019-03-08 |
ES2931468T3 (es) | 2022-12-29 |
CN109431595B (zh) | 2019-04-26 |
EP3881786A4 (en) | 2022-01-26 |
EP3881786A1 (en) | 2021-09-22 |
KR102548744B1 (ko) | 2023-06-27 |
US11986230B2 (en) | 2024-05-21 |
US20220015815A1 (en) | 2022-01-20 |
JP7145333B2 (ja) | 2022-09-30 |
JP2022514544A (ja) | 2022-02-14 |
EP3881786B1 (en) | 2022-10-19 |
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