A low-temperature cryofreezing and rotary cutting device and a rotary cutting system for breast tumor diagnosis

Abstract

The application discloses a low-temperature freezing rotary cutting device and a rotary cutting system for breast tumor diagnosis. The outer tube outer layer and the outer tube inner layer are arranged on the fixing member, and a sampling groove is formed by the slot opening and the sealing structure. The inner tube and the inner cutting blade are arranged in the outer tube inner layer. The sealed cavity formed between the outer tube outer layer and the outer tube inner layer is divided into an expansion cavity and a backflow cavity. The air inlet structure is arranged to extend into the expansion cavity to output the refrigerant. The outer tube outer layer is provided with an insulating material layer to isolate the cold energy transmission. The tumor tissue is sucked into the sampling groove under negative pressure. The refrigerant is released into the expansion cavity through the air inlet structure to expand and cool. The cold energy is transmitted to the sampling groove through the outer tube inner layer to freeze the tumor tissue, so that the original biological elasticity is lost. Then, the tissue is rotary cut by the inner cutting blade on the inner tube, and the cutting efficiency and the sampling efficiency are improved.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, and particularly relates to a low-temperature cryo-slicing device and a slicer system for the diagnosis of breast tumors. Background Technology

[0002] Breast cancer is a malignant tumor originating from the epithelium of the lobular units of the terminal ducts of the breast. Worldwide, breast cancer has become the most common malignant tumor among women; its mortality rate is rising annually. Distant metastasis of breast cancer is considered a leading cause of cancer death. Therefore, early diagnosis and timely treatment are currently the most effective methods to improve survival rates.

[0003] Breast biopsy is the gold standard for diagnosing breast cancer. Vacuum-assisted excision is a surgical procedure that allows for multiple cuts with a single needle insertion under ultrasound guidance. Clinically, it is commonly used for the removal of benign breast tumors and for biopsy diagnosis of breast cancer.

[0004] Existing technology typically involves the host providing negative pressure to the puncture needle. When the puncture needle reaches the location of the breast tumor, the negative pressure suction draws the tumor into the sampling groove of the puncture needle. Then, the cutting blade removes the tumor from the sampling groove and transports it to the sample collection chamber. This method often fails to achieve effective cutting because the negative pressure suction is not strong enough and there is insufficient adhesion.

[0005] On the other hand, the most common benign breast tumor, fibroadenoma, is a benign tumor composed of a mixture of glandular epithelium and fibrous tissue. It has regular edges, a smooth surface, is elastic, highly mobile, and not adherent to the skin. This elastic biological characteristic often results in sheets of tissue getting stuck around the cutting edge during resection, making effective tissue removal impossible. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to provide a low-temperature cryoablation device and an ablation system for the diagnosis of breast tumors, so as to solve the problem that existing ablation devices are difficult to effectively remove tissue.

[0007] To solve the above problems, the technical solution of the present invention is as follows:

[0008] A cryogenic freezing and slicing apparatus of the present invention includes:

[0009] The fastener has an inner tube opening.

[0010] The outer tube inner layer has its tail end fixed to the fixing member, and the inner cavity of the outer tube inner layer cooperates with the opening of the inner tube to form a rotary cutting cavity;

[0011] The outer tube has an outer layer, the first end of which is provided with a puncture tip, the tail end of which is fixed to the fixing member, and the outer tube is sleeved on the inner layer of the outer tube; the outer tube and the inner layer of the outer tube have sampling grooves that are radially opened on them, communicating with the rotary cutting cavity and penetrating at least part of the intermediate cavity.

[0012] A sealing structure is provided at the sampling groove to seal the gap between the outer layer of the outer tube and the inner layer of the outer tube and form a sealed cavity between the outer layer of the outer tube and the inner layer of the outer tube; the plane at the tail end of the sampling groove and perpendicular to the axis divides the sealed cavity into an expansion cavity near the puncture tip and a reflux cavity away from the puncture tip.

[0013] An intake structure penetrates the outer layer of the outer tube and extends into the expansion chamber, for outputting refrigerant into the expansion chamber;

[0014] An insulating material layer is disposed on the outer layer of the outer tube to prevent the cold air in the expansion cavity from being transferred to the outside.

[0015] An inner tube extends into and is movably connected to the rotary cutting cavity. The first end of the inner tube is provided with an inner cutting blade, and the tail end of the inner tube is used to connect to the negative pressure end of the main unit.

[0016] Once positioned at the target location, the sampling slot draws in the target object through a negative pressure created by the rotary cutting cavity and the negative pressure end of the main unit. The refrigerant is released into the expansion chamber through the air intake structure for expansion and cooling. The cooling energy is transferred to the sampling slot through the inner layer of the outer tube between the expansion chamber and the sampling slot to freeze the target object. The insulation material layer prevents the cooling energy in the expansion chamber from being transferred to the outside. After freezing is complete, the inner tube and the inner cutting blade rotate forward axially, cutting and separating the target object into the sampling slot.

[0017] The low-temperature freezing rotary cutting device of the present invention includes an air inlet structure comprising an air inlet interface, an air inlet seal, and at least one air inlet pipe;

[0018] An air inlet is provided on the outer layer of the outer tube; the first end of the air inlet interface is connected to the air inlet, and the second end of the air inlet interface is used to connect to the external refrigerant supply end;

[0019] The air inlet seal is located at the connection between the air inlet interface and the air inlet opening, and the air inlet seal is formed with at least one small air inlet hole.

[0020] The intake pipe is arranged in the reflux chamber, and the first end of the intake pipe extends into the expansion chamber, while the tail end of the intake pipe is inserted into the intake hole and extends into the intake interface.

[0021] The air inlet pipe is located inside the expansion chamber and has several refrigerant outlet holes on its surface facing the sampling slot.

[0022] In the cryogenic varistor of the present invention, the first ends of several air inlet pipes are arranged at intervals around the axis of the inner layer of the outer pipe within the expansion chamber.

[0023] In the low-temperature freezing rotary cutting device of the present invention, the refrigerant outlet is a plurality of throttling holes arranged axially at intervals on the air inlet pipe, and the cross-sectional area of ​​the throttling holes is smaller than the cross-sectional area of ​​the air inlet pipe.

[0024] In the low-temperature freezing rotary cutting device of the present invention, the outer layer of the outer tube and the inner layer of the outer tube are respectively provided with corresponding first slots and second slots, and the projections of the first slots and the second slots on the horizontal plane are both rectangles;

[0025] The sealing structure is disposed between the opening of the first slot and the opening of the second slot, and cooperates to form the sampling groove located in the inner layer of the outer tube, and cooperates to form a semi-annular cavity located between the inner layer of the outer tube and the outer layer of the outer tube, the semi-annular cavity being the expansion cavity.

[0026] The low-temperature freezing rotary cutting device of the present invention has a fixing member as a fixing sleeve, and the fixing sleeve is provided with an inner tube opening for the inner tube to pass through and a refrigerant outflow interface.

[0027] The fixed sleeve is provided with a sleeve mounting groove concentric with the opening of the inner tube, and the tail ends of the inner layer of the outer tube and the outer layer of the outer tube are respectively sealed and connected in the sleeve mounting groove.

[0028] The refrigerant outlet port passes through the fixed sleeve and the first end of the refrigerant outlet port is connected to the inner cavity of the sleeve mounting groove. The second end of the refrigerant outlet port is used to connect to the external refrigerant recovery end.

[0029] The outer end of the outer tube is provided with a refrigerant outlet hole that connects to the refrigerant outlet interface.

[0030] In the low-temperature freezing rotary cutting device of the present invention, a tail end cap 11 is provided between the tail end of the inner layer of the outer tube and the tail end of the outer layer of the outer tube for sealing the reflux cavity.

[0031] In the low-temperature freezing rotary cutting device of the present invention, the heat insulation material layer is PTFE.

[0032] The low-temperature freezing rotary cutting device of the present invention further includes a dynamic sealing structure disposed between the inner tube opening and the inner tube, for sealing the tube gap between the inner tube opening and the inner tube in a first structural state, so that the tube gap is not connected with the external atmosphere, and connecting the tube gap with the external atmosphere in a second structural state.

[0033] The present invention provides a rotary cutting system for the diagnosis of breast tumors, comprising the cryogenic rotary cutting device described in any one of the above-mentioned claims.

[0034] Because the present invention adopts the above technical solution, it has the following advantages and positive effects compared with the prior art:

[0035] In one embodiment of the present invention, an outer tube and an inner tube are sleeved on a fixing member, and slots are formed on both and sealed by a sealing structure to form a sampling groove for aspirating tumor tissue. The first end of the outer tube is provided with a puncture tip, and the inner tube is provided with an inner tube with an inner cutting blade at the first end. The sealed cavity formed between the outer tube and the inner tube is divided into an expansion cavity corresponding to the sampling groove and a return cavity at the tail end. Furthermore, an air intake structure is provided to extend into the expansion cavity to output refrigerant, and an insulating material layer is provided on the outer tube to isolate the transfer of cold energy. After the tumor tissue is drawn into the sampling tank under negative pressure, the refrigerant is released into the expansion chamber through the air intake structure for expansion and cooling. The cold energy is transferred to the sampling tank through the inner layer of the outer tube between the expansion chamber and the sampling tank, freezing the tumor tissue and causing it to lose its original biological elasticity. The tissue is then effectively removed by rotating it with the inner cutting blade on the inner tube. During the rotational cutting with the inner cutting blade, there is no slippage, which greatly improves the cutting efficiency and reduces the possibility of the negative pressure passage being blocked by the cutting blade, thus improving the sampling efficiency. The heat insulation material layer on the outer layer of the outer tube can isolate the cold energy and avoid affecting the surrounding normal tissue.

[0036] 2. In the existing technology, patients usually feel the discomfort of physical traction during the negative pressure adsorption of tumor tissue. In one embodiment of the present invention, the adsorbed tissue is frozen at the moment of vacuum adsorption. Since the human body is not sensitive to cold, it will produce a certain freezing analgesia effect on the surgical site, improve the patient's tolerance to the rotary excision surgery, and has extremely high clinical application value. Attached Figure Description

[0037] Figure 1 This is a schematic diagram of the low-temperature freezing rotary cutting device of the present invention;

[0038] Figure 2 This is a cross-sectional view of the cryogenic rotary cutting apparatus of the present invention;

[0039] Figure 3 This is a cross-sectional view of the cryogenic rotary cutting device of the present invention along direction A;

[0040] Figure 4 The low-temperature freezing rotary cutting device of the present invention is in Figure 2 An enlarged cross-sectional view of position B;

[0041] Figure 5 The low-temperature freezing rotary cutting device of the present invention is in Figure 2 Enlarged cross-sectional view of position C.

[0042] Explanation of reference numerals in the attached drawings: 1: Puncture tip; 101: Refrigerant outlet hole; 102: Air inlet; 103: Air inlet seal; 104: Small air inlet hole; 2: Sampling groove; 21: Sampling groove opening; 3: Fixing sleeve; 31: Refrigerant outlet; 32: Sleeve mounting groove; 33: Inner tube opening; 4: Inner tube; 41: Inner cutting edge; 42: Tail end of inner tube; 5: Outer layer of outer tube; 51: First 52: Insulation material layer; 53: Outer end of outer tube; 6: Inner layer of outer tube; 61: Second groove; 62: Outer end of inner tube; 7: Puncture tip cap; 8: Sealing structure; 9: Inlet pipe; 91: Refrigerant outlet hole; 92: Inlet pipe plug; 93: Left inlet pipe; 94: Right inlet pipe; 95: Semi-annular cavity; 10: Return cavity; 11: End cap; 12: Protrusion. Detailed Implementation

[0043] The following detailed description, in conjunction with the accompanying drawings and specific embodiments, provides a cryogenic cryo-slicing device and a slicer system for breast tumor diagnosis based on the present invention. The advantages and features of the present invention will become clearer from the following description and claims.

[0044] Example 1

[0045] See Figures 1 to 5 In one embodiment, a cryogenic slicing device includes a fixing member, an inner layer 6 of an outer tube, an outer layer 5 of an outer tube, a sealing structure 8, an air inlet structure, an insulation material layer 52, and an inner tube 4.

[0046] The tail end of the inner layer 6 of the outer tube is fixed to the fixing member, and the inner cavity of the inner layer 6 of the outer tube cooperates with the inner tube opening 33 on the fixing member to form a rotary cutting cavity. The inner tube 4 is configured to extend into and be movably connected to the rotary cutting cavity. The head end of the inner tube 4 is provided with an inner cutting blade 41, and the tail end of the inner tube 4 is used to connect to the negative pressure end of the main unit. That is, the inner tube 4 can rotate and move back and forth within the inner layer 6 of the outer tube. By moving back and forth and rotating, it can be extended into the sampling slot 2 to complete the rotary cutting of tumor tissue.

[0047] The tail end of the outer tube outer layer 5 is fixed to a fastener, and the outer tube outer layer 5 is sleeved on the outer tube inner layer 6. A sampling groove 2, which connects the outer tube outer layer 5 and the outer tube inner layer 6 radially and penetrates at least part of the intermediate cavity, is formed. The head end of the outer tube outer layer 5 is provided with a puncture tip 1, wherein the tail end of the puncture tip 1 has a protrusion 12, which is coaxially embedded in the outer tube outer layer 5. The puncture tip cap 7 is disposed in the gap between the outer tube outer layer 5 and the outer tube inner layer 6, sealing the gap between them.

[0048] The sealing structure 8 is located at the sampling groove 2 to seal the gap between the outer layer 5 and the inner layer 6 of the outer tube and to form a sealed cavity between the outer layer 5 and the inner layer 6 of the outer tube. The surface at the tail end of the sampling groove 2, which is perpendicular to the axis, divides the sealed cavity into an expansion cavity near the puncture tip 1 and a reflux cavity 10 away from the puncture tip 1.

[0049] The intake structure is designed to penetrate the outer layer 5 of the outer tube and extend into the expansion chamber, for outputting refrigerant into the expansion chamber for expansion and cooling. The insulation material layer 52 is disposed on the outer layer 5 of the outer tube to prevent the cold air in the expansion chamber from being transferred to the outside.

[0050] In this embodiment, after the cryogenic rotary cutting device is positioned at the tumor location, a negative pressure is created in the sampling tank 2 through the rotary cutting cavity and the negative pressure end of the main unit to draw in tumor tissue. The refrigerant is released into the expansion chamber through the air intake structure for expansion and cooling. The cooling energy is transferred to the target material in the sampling tank 2 via the inner layer 6 of the outer tube between the expansion chamber and the sampling tank 2. The insulation material layer 52 prevents the cooling energy in the expansion chamber from being transferred to the outside. After freezing, the inner tube 4 and the inner cutting blade 41 rotate forward axially, cutting and separating the target material into the sampling tank 2. The refrigerant used for cooling is subsequently recovered through the reflux chamber 10.

[0051] In this embodiment, an outer tube outer layer 5 and an outer tube inner layer 6 are sleeved on a fixing member. Both have slots and are sealed by a sealing structure 8 to form a sampling groove 2 for aspirating tumor tissue. The first end of the outer tube outer layer 5 is provided with a puncture tip 1, and the outer tube inner layer 6 is provided with an inner tube 4 with an inner cutting blade 41 at the first end. The sealed cavity formed between the outer tube outer layer 5 and the outer tube inner layer 6 is divided into an expansion cavity corresponding to the sampling groove 2 and a return cavity 10 at the tail end. Furthermore, an air intake structure is provided to extend into the expansion cavity to output refrigerant, and an insulation material layer 52 is provided on the outer tube outer layer 5 to isolate the transfer of cold energy. After the tumor tissue is drawn into the sampling tank 2 under negative pressure, the refrigerant is released into the expansion chamber through the air intake structure for expansion and cooling. The cold energy is transferred to the sampling tank 2 through the inner layer 6 of the outer tube between the expansion chamber and the sampling tank 2 to freeze the tumor tissue. The tissue is instantly frozen to below zero degrees Celsius, causing it to lose its original biological elasticity. The breast tumor tissue is divided into two parts at the sampling tank opening 21: frozen tissue and unfrozen tissue. There is a clear temperature boundary between the two parts, which is easily cut by the inner cutting blade 41, greatly improving the cutting efficiency. The tissue is then rotated and cut by the inner cutting blade 41 on the inner tube 4, achieving effective resection. Furthermore, because the breast tumor tissue drawn into the sampling tank 2 has lost its original biological elasticity, it no longer slips when rotated by the inner cutting blade 41, greatly improving the cutting efficiency and reducing the possibility of the tissue getting stuck on the cutting blade and causing blockage of the negative pressure passage, thus improving the sampling efficiency. The heat insulation material layer 52 on the outer layer 5 of the outer tube can isolate the cold energy and avoid affecting the surrounding normal tissue.

[0052] Furthermore, this embodiment freezes the aspirated tissue at the moment of vacuum adsorption. Since the human body is not sensitive to cold, it will produce a certain cryo-analgesic effect on the surgical site, thereby improving the patient's tolerance to the excision procedure and having extremely high clinical application value.

[0053] The specific structure of the low-temperature freezing rotary cutting device in this embodiment will be further described below:

[0054] In this embodiment, the air intake structure may specifically include an air intake interface 102, an air intake seal 103, and at least one air intake pipe 9.

[0055] An air intake opening is provided on the outer layer 5 of the outer tube, connecting the inside and outside. The first end of the air intake interface 102 is connected to the air intake opening, and the second end of the air intake interface 102 is used to connect to the external refrigerant supply end.

[0056] The air inlet seal 103 is located at the connection between the air inlet interface 102 and the air inlet opening, and is used to fill and seal the connection. The air inlet seal 103 has at least one air inlet hole 104 formed inside, which connects the inner cavity of the outer layer 5 of the outer tube and the inner cavity of the air inlet interface 102. The number of air inlet pipes 9 corresponds one-to-one with the number of air inlet holes 104. The main body of the air inlet pipe 9 is arranged in the return cavity 10, and the first end of the air inlet pipe 9 extends into the expansion cavity. The tail end of the air inlet pipe 9 is sealed and inserted into the air inlet hole 104 and extends into the air inlet interface 102, thereby introducing refrigerant into the air inlet interface 102.

[0057] The head of the air intake pipe 9 is sealed by the air intake pipe plug 92. The air intake pipe plug 92 can be made of glue or solder, as long as it can withstand the air intake pressure. The air intake pipe plug 92 is connected and fixed to the protrusion 12 at the tail of the puncture tip. The connection method can be glue or welding. The air intake pipe 9 is located in the expansion chamber and has several refrigerant outlet holes 91 on its surface facing the sampling groove 2, so as to spray refrigerant towards the inner layer 6 of the outer tube corresponding to the sampling groove 2.

[0058] Furthermore, in order to ensure that the cooling capacity transferred from the inner layer 6 of the outer tube to the sampling tank 2 is uniform, the beginning ends of the multiple air inlet pipes 9 can be arranged at intervals around the axis of the inner layer 6 of the outer tube in the expansion chamber, that is, arranged at intervals in the expansion chamber in the circumferential direction, and the refrigerant outlet holes 91 on each air inlet pipe 9 are all set towards the axis of the inner layer 6 of the outer tube.

[0059] See Figure 3 In this embodiment, the number of intake pipes 9 can be three: an intake pipe 9 located at the bottom of the sampling tank 2, and a left intake pipe 93 and a right intake pipe 94 located on both sides of the sampling tank 2. Of course, in other embodiments, the number of intake pipes 9 can be more than three. The more intake pipes 9 there are, the more uniformly the refrigerant is filled into the expansion chamber.

[0060] Specifically, the refrigerant outlet orifice 91 can be a plurality of throttling orifices spaced axially on the intake pipe 9. The length of the throttling orifice on the intake pipe 9 should just cover the entire axial length of the sampling groove 2, and the cross-sectional area of ​​the throttling orifice should be smaller than the cross-sectional area of ​​the intake pipe 9. The smaller the diameter of the intake pipe 9, the better the cooling effect when the refrigerant reaches the expansion chamber. In this embodiment, the head of the intake pipe 9 is completely sealed to ensure that the refrigerant provided by the system can be accurately sprayed out along the throttling orifice. The size and number of throttling orifices can be designed arbitrarily, as long as the diameter of the throttling orifice is smaller than the size of the intake pipe 9.

[0061] In this embodiment, the opening forming the sampling groove 2 can be a first groove 51 and a second groove 61 respectively formed on the outer layer 5 and the inner layer 6 of the outer tube, wherein the projections of the first groove 51 and the second groove 61 on the horizontal plane can both be rectangular. The sealing structure 8 is disposed between the opening of the first groove 51 and the opening of the second groove 61, and cooperates to form the sampling groove 2 located in the inner layer 6 of the outer tube, and cooperates to form a semi-annular cavity 95 located between the inner layer 6 and the outer layer 5 of the outer tube, the semi-annular cavity 95 being the aforementioned expansion cavity. The sealing structure 8 can be a sampling groove end cap, fixed and sealed between the inner layer 6 and the outer layer 5 of the outer tube by means of adhesive or the like.

[0062] In this embodiment, the fixing member may specifically be a fixing sleeve 3, which is provided with an inner tube opening 33 for the inner tube 4 to pass through and a refrigerant outlet 31.

[0063] The fixed sleeve 3 is provided with a sleeve mounting groove 32 concentric with the inner tube opening 33, and the tail ends of the outer tube inner layer 6 and the outer tube outer layer 5 are respectively sealed and connected in the sleeve mounting groove 32.

[0064] The refrigerant outlet 31 can be configured to obliquely penetrate the fixed sleeve 3, with its first end (the upper end) connected to the inner cavity of the sleeve mounting groove 32, and its second end (the lower end) used to connect to the external refrigerant recovery end. The tail end of the outer tube 5 is provided with a refrigerant outlet hole 101 connecting to the refrigerant outlet 31. Specifically, the hole 101 can be located at the portion of the outer tube 5 inserted into the fixed sleeve 3. That is, the refrigerant in the recovery chamber can enter the refrigerant outlet 31 through the refrigerant outlet hole 101 and be drawn out to the external refrigerant recovery end.

[0065] In this embodiment, a tail end cap 11 is provided between the inner end 62 and the outer end 53 of the outer tube to seal the reflux cavity 10. That is, the tail end cap 11 is provided at the inner layer 6, the outer layer 5, and the sleeve mounting groove 32. The tail end cap 11 can be connected and sealed to the inner layer 6 and the outer layer 5 by means of adhesive or welding.

[0066] In this embodiment, the heat insulation layer 52 can be disposed on the outer wall surface of the outer tube outer layer 5, and the material of the heat insulation layer 52 can be a heat-insulating and non-stick material such as PTFE, so that the cold energy in the semi-annular cavity 95 can only be transferred from the inner layer 6 of the outer tube to the sampling slot 2. In this way, breast tumor tissue that is not sucked into the sampling slot 2 will not be frozen indiscriminately, so that it can be effectively sucked into the sampling slot 2 by the negative pressure of the system before the next cycle of cutting.

[0067] In this embodiment, the refrigerant is any refrigerant that can generate a temperature difference using the Joule-Thomson effect, including CO2, N2O, etc. The storage form of the refrigerant can be a pressurized gas cylinder (external refrigerant supply end), etc.

[0068] In this embodiment, the diameter of the inner tube 4 at the inner cutting blade 41 is equal to or slightly smaller than the inner diameter of the inner layer 6 of the outer tube. This tight fit will allow the inner cutting blade 41 to completely remove abnormal breast tissue without trapping the tissue in the gap between the two.

[0069] In this embodiment, the shape of the puncture tip 1 and the inner cutting blade 41 can be in various forms, as long as it ensures successful puncture to the location of the breast tumor.

[0070] In this embodiment, the cryogenic rotary cutting device may further include a dynamic sealing structure 8, disposed between the inner tube opening 33 and the inner tube 4, for sealing the inter-tube gap between the inner tube opening 33 and the inner tube 4 in a first structural state, so that the inter-tube gap is not connected to the external atmosphere, and in a second structural state, connecting the inter-tube gap to the external atmosphere. Specifically, the dynamic sealing structure 8 may include a sealing ring disposed at the inner tube opening 33 and a connecting structure disposed at the tail end 42 of the inner tube. When the inner tube 4 and the inner cutting blade 41 are not in the sampling groove 2, the sealing ring contacts the outer wall surface of the inner tube 44 to achieve a seal; when the inner tube 4 and the inner cutting blade 41 enter the sampling groove 2 for rotary cutting, as the inner tube 4 moves forward, the connecting structure on it contacts the sealing ring, thereby releasing the seal at the connecting structure.

[0071] All of the above-mentioned sealing connection methods can be adhesive bonding, welding, tight fitting, or any other form that can serve to fix and seal the connection.

[0072] Example 2

[0073] This embodiment provides a rotary cutting system for breast tumor diagnosis, including the cryogenic rotary cutting device described in Embodiment 1 above. An outer tube outer layer 5 and an inner tube 6 are sleeved on a fixing member, both with slots and sealed by a sealing structure 8 to form a sampling groove 2 for aspirating tumor tissue. The outer tube outer layer 5 has a puncture tip 1 at its tip, and the inner tube 6 contains an inner tube 4 with an inner cutting blade 41 at its tip. The sealed cavity formed between the outer tube outer layer 5 and the inner tube 6 is divided into an expansion cavity corresponding to the sampling groove 2 and a reflux cavity 10 at its tail end. An air inlet structure extends into the expansion cavity to output refrigerant, and an insulating material layer 52 is provided on the outer tube outer layer 5 to isolate the transfer of cold energy. After the tumor tissue is drawn into the sampling tank 2 under negative pressure, the refrigerant is released into the expansion chamber through the air intake structure for expansion and cooling. The cold energy is transferred to the sampling tank 2 through the inner layer 6 of the outer tube between the expansion chamber and the sampling tank 2 to freeze the tumor tissue, causing it to lose its original biological elasticity. Then, the tissue is cut by the inner cutting blade 41 on the inner tube 4, which can achieve effective removal. During the cutting by the inner cutting blade 41, there is no slippage, which greatly improves the cutting efficiency and reduces the possibility of the negative pressure passage being blocked by the tissue stuck on the cutting blade, thus improving the sampling efficiency. The heat insulation material layer 52 on the outer layer 5 of the outer tube can isolate the cold energy and avoid affecting the surrounding normal tissue.

[0074] The specific surgical procedure of the excision system for breast tumor diagnosis in this embodiment is described below:

[0075] During the sampling procedure, when breast tumor tissue is drawn into the sampling slot 2 by negative pressure along the inner lumen of the inner tube 4, pressurized refrigerant is sprayed into the air inlet pipe 9 through the main unit pipeline, exiting through the throttling orifice. This creates cooling in the semi-annular cavity 95 covering the sampling slot 2. The cold energy is transferred through the inner layer 6 of the outer tube to the breast tumor tissue drawn into the sampling slot 2, instantly freezing the tissue to below zero degrees Celsius. The breast tumor tissue is separated into frozen and unfrozen parts at the sampling slot opening 21, with a clear temperature boundary between them. This temperature boundary is easily severed by the inner cutting blade 41, greatly improving cutting efficiency. Furthermore, the breast tumor tissue in the sampling slot 2 loses its original biological elasticity and no longer slips when cut by the inner cutting blade 41, further improving cutting efficiency and reducing the possibility of tissue blockage. The removed tissue is finally transported to the sample collection chamber by the system under negative pressure, thus completing one cycle of the sampling procedure. The refrigerant injected through the throttling orifice fills the semi-annular cavity and then flows back into the return cavity 10 along the outer layer 5 of the outer tube. It then enters the refrigerant outlet port 31 through the refrigerant outlet hole 101 and is drawn out to the external refrigerant recovery end and discharged from the system.

[0076] The embodiments of the present invention have been described in detail above with reference to the accompanying drawings, but the present invention is not limited to the above embodiments. Even if various changes are made to the present invention, if these changes fall within the scope of the claims of the present invention and their equivalents, they shall still fall within the protection scope of the present invention.

Claims

1. A low-temperature freezing rotary cutting device, characterized in that, include: The fastener has an inner tube opening. The outer tube inner layer has its tail end fixed to the fixing member, and the inner cavity of the outer tube inner layer cooperates with the opening of the inner tube to form a rotary cutting cavity; The outer tube has an outer layer, the first end of which is provided with a puncture tip, the tail end of which is fixed to the fixing member, and the outer tube is sleeved on the inner layer of the outer tube; the outer tube and the inner layer of the outer tube have sampling grooves that are radially opened on them, communicating with the rotary cutting cavity and penetrating at least part of the intermediate cavity. A sealing structure is provided at the sampling groove to seal the gap between the outer layer of the outer tube and the inner layer of the outer tube and form a sealed cavity between the outer layer of the outer tube and the inner layer of the outer tube; the plane at the tail end of the sampling groove and perpendicular to the axis divides the sealed cavity into an expansion cavity near the puncture tip and a reflux cavity away from the puncture tip. An intake structure penetrates the outer layer of the outer tube and extends into the expansion chamber, for outputting refrigerant into the expansion chamber; An insulating material layer is disposed on the outer layer of the outer tube to prevent the cold air in the expansion cavity from being transferred to the outside. An inner tube extends into and is movably connected to the rotary cutting cavity. The first end of the inner tube is provided with an inner cutting blade, and the tail end of the inner tube is used to connect to the negative pressure end of the main unit. Once positioned at the target location, the sampling slot draws in the target object through a negative pressure created by the rotary cutting cavity and the negative pressure end of the main unit. The refrigerant is released into the expansion chamber through the air intake structure for expansion and cooling. The cooling energy is transferred to the sampling slot through the inner layer of the outer tube between the expansion chamber and the sampling slot to freeze the target object. The insulation material layer prevents the cooling energy in the expansion chamber from being transferred to the outside. After freezing is complete, the inner tube and the inner cutting blade rotate forward axially, and the target object is cut and separated into the sampling slot. The outer layer of the outer tube and the inner layer of the outer tube are respectively provided with a first slot and a second slot, and the projection of the first slot and the second slot on the horizontal plane are both rectangles; The sealing structure is disposed between the opening of the first slot and the opening of the second slot, and cooperates to form the sampling groove located in the inner layer of the outer tube, and cooperates to form a semi-annular cavity located between the inner layer of the outer tube and the outer layer of the outer tube, the semi-annular cavity being the expansion cavity; It also includes a dynamic sealing structure disposed between the inner tube opening and the inner tube, used to seal the gap between the inner tube opening and the inner tube when the inner tube does not enter the sampling groove, so that the gap between the tubes is not connected to the outside atmosphere, and to connect the gap between the tubes and the outside atmosphere when the inner tube enters the sampling groove.

2. The low-temperature freezing rotary cutting device as described in claim 1, characterized in that, The air intake structure includes an air intake interface, an air intake seal, and at least one air intake pipe; An air inlet is provided on the outer layer of the outer tube; the first end of the air inlet interface is connected to the air inlet, and the second end of the air inlet interface is used to connect to the external refrigerant supply end; The air inlet seal is located at the connection between the air inlet interface and the air inlet opening, and the air inlet seal is formed with at least one small air inlet hole. The intake pipe is arranged in the reflux chamber, and the first end of the intake pipe extends into the expansion chamber, while the tail end of the intake pipe is inserted into the intake hole and extends into the intake interface. The air inlet pipe is located inside the expansion chamber and has several refrigerant outlet holes on its surface facing the sampling slot.

3. The low-temperature freezing rotary cutting device as described in claim 2, characterized in that, The first ends of several of the intake pipes are arranged at intervals around the axis of the inner layer of the outer pipe within the expansion cavity.

4. The low-temperature freezing rotary cutting device as described in claim 2, characterized in that, The refrigerant outlet is a plurality of throttling orifices arranged axially at intervals on the intake pipe, and the cross-sectional area of ​​the throttling orifices is smaller than the cross-sectional area of ​​the intake pipe.

5. The low-temperature freezing rotary cutting device as described in claim 1, characterized in that, The fixing component is a fixing sleeve, which has an opening for the inner tube to pass through and a refrigerant outlet. The fixed sleeve is provided with a sleeve mounting groove concentric with the opening of the inner tube, and the tail ends of the inner layer of the outer tube and the outer layer of the outer tube are respectively sealed and connected in the sleeve mounting groove. The refrigerant outlet port passes through the fixed sleeve and the first end of the refrigerant outlet port is connected to the inner cavity of the sleeve mounting groove. The second end of the refrigerant outlet port is used to connect to the external refrigerant recovery end. The outer end of the outer tube is provided with a refrigerant outlet hole that connects to the refrigerant outlet interface.

6. The low-temperature freezing rotary cutting device as described in claim 1, characterized in that, A tail end cap is provided between the tail end of the inner layer of the outer tube and the tail end of the outer layer of the outer tube to seal the reflux cavity.

7. The low-temperature freezing rotary cutting device as described in claim 1, characterized in that, The insulation material layer is PTFE.

8. A rotary cutting system for the diagnosis of breast tumors, characterized in that, Includes the cryogenic freezing rotary cutting apparatus as described in any one of claims 1 to 7.

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