CN214231494U

CN214231494U - Cryoablation catheter and cryoablation device

Info

Publication number: CN214231494U
Application number: CN202022048006.XU
Authority: CN
Inventors: 王茂强; 徐宏
Original assignee: Hangzhou Kunbo Biotechnology Co Ltd
Current assignee: Hangzhou Kunbo Biotechnology Co Ltd
Priority date: 2020-09-17
Filing date: 2020-09-17
Publication date: 2021-09-21
Anticipated expiration: 2030-09-17

Abstract

The application discloses a cryoablation catheter and a cryoablation device, wherein the cryoablation catheter comprises a catheter body, the catheter body is provided with a far end and a near end which are opposite to each other, an input channel and an output channel for conveying cooling media are arranged in the catheter body, and the input channel and the output channel are communicated through a jet hole at the far end of the catheter body; compared with the prior art, the cryoablation catheter has the advantages that the spiral part of the shaping piece can be conveyed to the far end of the catheter body by controlling the near end part of the shaping piece, and the shaping piece is convenient to install in the catheter body.

Description

Cryoablation catheter and cryoablation device

Technical Field

The application relates to the field of medical equipment, in particular to a cryoablation catheter and a cryoablation device.

Background

The cryoablation is to inactivate the pathological tissues of a human body by utilizing the freezing energy released by a freezing source so as to achieve the purpose of treatment. The cryoablation technology is used for clinical treatment of tumors, atrial fibrillation and the like. Compared with the prior radio frequency ablation, the patient in the cryoablation reduces pain because the patient does not endure high temperature.

The principle of cryoablation is that the temperature of a target ablation part is reduced and abnormal electrophysiological cell tissues are destroyed by taking away tissue heat through heat absorption and evaporation of a refrigerant, so that the risk of arrhythmia is reduced or coagulation necrosis of pathological tissues is caused.

The prior art discloses a cryoablation catheter, which includes a sheath and a freezing unit located in the sheath, wherein when the cryoablation catheter reaches a lesion, the freezing unit ablates the lesion.

The shaped piece in the prior art refrigeration unit is too cumbersome to install.

SUMMERY OF THE UTILITY MODEL

In order to solve the above technical problem, the present application provides a cryoablation catheter comprising a tubular body having opposite distal and proximal ends, the tubular body having an inlet channel and an outlet channel for delivering a cooling medium therein, the inlet channel and the outlet channel being in communication at the distal end of the tubular body through an injection hole;

the cryoablation catheter further comprises a shaping piece extending from the far end to the near end, and the far end part of the shaping piece is in a spiral shape and used for shaping the catheter body.

The input channel is used for conveying the cooling medium to the output channel, and a cooling medium circuit is formed between the input channel and the output channel. After entering the input channel, the cooling medium enters the output channel through the jet holes and is discharged from the output channel, and the cooling medium cools the far end part of the tube body.

Since the shaping member extends from the distal end to the proximal end, the helical portion of the shaping member can be delivered to the distal end of the tubular body by manipulating the proximal portion of the shaping member without the use of an external instrument.

This application is through reducing the pipe diameter that cryoablation pipe was managed to realize that the body can stretch into and melt to thinner bronchus in, with the application scene that adapts to more

Several alternatives are provided below, but not as an additional limitation to the above general solution, but merely as a further addition or preference, each alternative being combinable individually for the above general solution or among several alternatives without technical or logical contradictions.

Optionally, the input channel is located on an inner side of the spiral relative to the output channel, and the injection holes are directed towards an outer side of the spiral.

The cooling medium flows to the inner wall of the spiral outer side from the jet holes so as to rapidly cool the spiral outer side.

Optionally, the pipe body includes an outer pipe and a first inner pipe located in the outer pipe, the input channel is located in the first inner pipe, the output channel is located in a gap between the first inner pipe and the outer pipe, and the injection hole is opened in a pipe wall of the first inner pipe.

The cooling medium in the input channel flows out from the injection hole to the output channel, and a cooling medium loop is formed between the input channel and the output channel. The first inner pipe is positioned in the outer pipe, and the cooling medium in the output channel is positioned outside the first inner pipe, so that the energy loss of the cooling medium in the input channel can be reduced.

Optionally, the cryoablation catheter further comprises a pulling member extending from a distal end to at least a proximal end, the catheter body further comprising an operation channel therein;

the shaping member and the pulling member are arranged side by side in the operating channel and are secured to each other adjacent the distal end of the tubular body.

In the process of ablation, the far end of the tube body needs to be stretched into the position near a focus, and then the position of the far end of the tube body can be adjusted through the traction piece, so that the bending of the far end of the tube body in a wider range can be realized.

Optionally, the cryoablation catheter further includes a coil spring and an inner sleeve penetrating through the operation channel, the inner sleeve extends from a distal end to a proximal end, the coil spring penetrates through the inner sleeve, and the fixing member and the traction member both penetrate through the coil spring.

When the traction piece is pulled to bend the spiral part, the inner wall of the spiral spring can support the traction piece, and the inner sleeve supports the traction piece. Meanwhile, the spiral spring can be matched with the shaping piece to keep the shape of the far end of the tube body.

Optionally, the cryoablation catheter is further provided with a second inner tube, the operation channel is located in the second inner tube, the first inner tube and the second inner tube are arranged in the outer tube side by side, and the output channel is located in a gap between the outer tube and the two inner tubes.

The second inner pipe can prevent the respective components in the operation passage from interfering with the flow of the cooling medium.

Optionally, the shape-fixing member has the input channel, an output channel for outputting a cooling medium is formed in a gap between the pipe body and the shape-fixing member, and the shape-fixing member is provided with the injection hole at a distal end portion of the pipe body, the injection hole communicating the input channel with the output channel.

A cooling medium loop is formed between the input channel and the output channel, and after entering the input channel, the cooling medium enters the output channel through the jet holes and is finally discharged from the output channel. Because the input channel is located the setting element, can reduce the pipe diameter of cryoablation pipe to realize that the body can stretch into and melt to more thin bronchus, in order to adapt to more application scenarios.

The application also provides the following technical scheme:

a cryoablation device comprises a catheter and an operating handle connected to the proximal end of the catheter, wherein the catheter adopts the cryoablation catheter.

The operator drives the cryoablation catheter to extend into the vicinity of the focus by holding the operating handle, and then the focus part is ablated by the cryoablation catheter, so that the operator can conveniently operate the cryoablation catheter.

Optionally, the operating handle includes a housing, an input joint, an output joint, and a bending adjustment assembly, and the input joint, the output joint, and the bending adjustment assembly are all mounted on the housing;

the shell is fixedly connected to the near end of the pipe body, the input connector is communicated with the input channel, the output connector is communicated with the output channel, and the bending adjusting assembly is connected with the traction piece and can drive the traction piece to move so as to drive the catheter to bend.

The operator drives the cryoablation catheter to extend into the focus through the operating handle, and drives the catheter to bend through the bending adjusting component, so that the far-end part of the catheter avoids tissues and organs, and the damage to the tissues and organs is reduced.

Optionally, the bending adjustment assembly includes a driven member and a driving member, and the housing is provided with a guide groove extending along the axial direction of the guide tube;

the driven piece is provided with a linkage part extending radially, the driven piece is movably arranged in the shell, the linkage part extends out of the guide groove, and the driven piece is connected with the traction piece;

the driving piece is sleeved on the shell and is in threaded fit with the linkage part, the driving piece rotates relative to the shell, and drives the driven piece to move in the rotating process so as to drive the conduit to bend.

The operator rotates the driving part, and the driving part drives the driven part to move along the axial direction of the catheter, so that the traction part drives the catheter to bend, the far end part of the catheter body avoids tissues and organs, and the damage to the tissues and organs is reduced.

Drawings

FIG. 1 is a schematic structural view of a cryoablation catheter in accordance with an embodiment of the present disclosure;

FIG. 2 is a schematic partial view of the cryoablation catheter of FIG. 1;

FIG. 3 is a partial schematic view of a cryoablation catheter according to one embodiment;

FIG. 4 is a partial cross-sectional view of a cryoablation catheter according to one embodiment;

FIG. 5 is a schematic structural view of the coil spring of FIG. 3;

FIG. 6 is a partial schematic structural view of the cryoablation catheter in the second embodiment;

FIG. 7 is a partial cross-sectional view of the cryoablation catheter of the second embodiment;

FIG. 8 is a schematic structural view of the coil spring of FIG. 6;

FIG. 9 is a schematic structural view of a cryoablation device according to an embodiment of the present disclosure;

FIG. 10 is a schematic view of the operating handle of FIG. 9 with a support housing omitted;

FIG. 10a is a schematic view of the fluid passage of a cryoablation catheter of FIG. 9 in accordance with one embodiment of the ablation catheter apparatus;

FIG. 10b is a schematic view of the fluid passage of the cryoablation catheter of FIG. 9 in a second embodiment;

FIG. 11 is a schematic view of the operating handle of FIG. 9 with the drive member omitted;

FIG. 12 is a partial schematic view of the operating handle of FIG. 9;

FIG. 13 is a cross-sectional view of the operating handle of FIG. 9;

FIG. 14 is a schematic view of the operating handle of FIG. 9 with a support housing and drive member omitted;

fig. 15 is a schematic structural view of the stress dispersion member of fig. 9.

The reference numerals in the figures are illustrated as follows:

100. a cryoablation device;

10. a cryoablation catheter; 11. a pipe body; 111. a distal end; 112. a proximal end; 113. an outer tube; 114. a first inner tube; 1141. an injection hole; 115. a second inner tube; 116. a shaping section; 117. an input channel; 118. an output channel; 119. an operation channel; 12. a shaping piece; 13. a traction member; 14. a coil spring; 141. a reed dredging section; 15. an inner sleeve;

20. an operating handle; 21. a housing; 211. a first support housing; 212. a second support housing; 213. a mounting cavity; 214. a guide groove; 22. an input connector; 23. an output connector; 24. a connector channel; 25. connecting sleeves; 26. a support member; 27. a bending adjusting component; 271. a driven member; 272. a drive member; 273. a linkage section; 274. an adjustment groove; 275. a through hole; 276. a pin shaft; 277. an anti-slip member; 28. a first seal member; 29. a second seal member;

30. a stress dispersion member; 31. installing a channel; 32. a connecting section; 33. an extension section; 34. and a limiting shoulder.

Detailed Description

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. When a component is referred to as being "disposed on" another component, it can be directly on the other component or intervening components may also be present.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the present application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

In the prior art, a cryoablation catheter comprises a sheath and a freezing unit located in the sheath, wherein the freezing unit is fixed in the sheath, the freezing unit comprises a shape memory mechanism in a preset shape, and when the cryoablation catheter reaches a lesion site, the expansion shape of the freezing unit is realized by the shape memory mechanism.

The inventors have found that the need for external instruments to feed the shape memory mechanism to the freezer unit and then secure it makes the installation of the shape memory mechanism cumbersome.

In one embodiment, as shown in fig. 1 to 8, the present application provides a cryoablation catheter 10, comprising a tubular body 11, the tubular body 11 having opposite distal 111 (the end near the patient) and proximal 112 (the end near the operator), the tubular body 11 having an inlet channel 117 and an outlet channel 118 for delivering a cooling medium, the inlet channel 117 and the outlet channel 118 both communicating at the distal end of the tubular body 11 through an injection hole 1141;

the cryoablation catheter 10 further includes a shaping member 12 extending from a distal end 111 to a proximal end 112, the distal portion of the shaping member 12 being helical for shaping the body 11.

The input channel 117 is used to feed the cooling medium to the output channel 118, and a cooling medium circuit is formed between the input channel 117 and the output channel 118. After entering the input channel 117, the cooling medium enters the output channel 118 through the injection holes 1141 and is discharged from the output channel 118, and the cooling medium cools the distal end portion of the tube body 11.

Since the shaping is extended from the distal end 111 to the proximal end 112, the helical portion of the shaping member 12 can be delivered to the distal end 111 of the tubular body 11 by manipulating the proximal portion of the shaping member 12 without the use of external instruments.

Simultaneously, this application is through reducing the pipe diameter of cryoablation pipe 10 to realize that body 11 can stretch into and melt to more thin bronchus in, with the application scenario that adapts to more.

The shape-imparting member 12 extends from a proximal end 112 to a distal end 111, the shape-imparting member 12 is heat set to a desired initial shape, and the shape-imparting member 12 returns to the initial shape in an in vivo environment, in one embodiment, the shape-imparting member 12 is a memory alloy, such as a nickel titanium wire.

When the shape-fixing element 12 drives the tube 11 to deform, the tube 11 will generate a reaction force against the shape-fixing element 12, which causes a slight deviation between the spiral shape and the initial shape, and thus the consistency between the two is not strictly limited, but at least a close spatial posture is obtained.

In order to allow the distal portion of the tubular body 11 to be shaped by the shaping member 12. In one embodiment, as shown in fig. 2, the distal portion of the tube 11 has a shaping section 116.

When the distal end of the tube 11 is shaped into a spiral shape, the outer side of the spiral shape will contact with the lesion first, in order to rapidly cool the outer side of the spiral shape, referring to an embodiment, the input channel 117 is located at the inner side of the spiral shape relative to the output channel 118, the injection hole 1141 faces the outer side of the spiral shape, and the cooling medium flows from the injection hole 1141 to the inner wall of the outer side of the spiral shape, so as to rapidly cool the outer side of the spiral shape.

Wherein, the inner side of the spiral is one side facing to the center of the spiral, and the outer side is one side back to the center of the spiral.

When the shaping member 12 shapes the distal end portion of the tube body 11 into a spiral shape, in order to rapidly cool the distal end portion of the tube body 11, referring to an embodiment, the number of the injection holes 1141 is plural, the plural injection holes 1141 are arranged at intervals along the extending direction of the inner tube, and when the shaping member 12 shapes the distal end portion of the tube body 11 into a spiral shape, the plural injection holes 1141 are distributed at the spiral shape.

Here, the output flow rates of the respective injection holes 1141 are equal or different.

In another embodiment, the flow aperture of spray orifices 1141 is equal from proximal end 112 to distal end 111.

The cooling medium enters the outlet passage 118 to expand and absorb heat to lower the temperature of the tube body 11, so that the outlet passage 118 has enough space for the cooling medium to expand. Referring to an embodiment, the cross-sectional area of the output channel 118 is S1, the cross-sectional area of the input channel 117 is S2, and S1 is 2 to 10 times of S2.

Preferably, S1 is 5-10 times of S2;

most preferably, S1 is 8-10 times of S2.

In another embodiment, the number of turns of the spiral is less than one, where the requirements on the shape-defining member 12 are reduced to facilitate the operation of the shape-defining member 12 in the outlet passage 118. The number of turns of the spiral is at least one, so that the cryoablation catheter 10 can carry out all-around ablation, the situation that the spiral position is adjusted by rotating the cryoablation catheter 10 to adapt to focuses at different positions can be avoided, and the operation difficulty of the cryoablation catheter 10 is reduced.

When the number of turns of the spiral is greater than one, referring to an embodiment, the spiral is a three-dimensional spiral having a center line, the center line is a geometric center of the three-dimensional spiral, the spiral extends along the center line, and each turn has an equal diameter.

Wherein the center line of the spiral is arranged substantially parallel to the axis of the pipe body 11.

One turn of the spiral is 360 degrees. In the present embodiment, the spiral shape is 360 to 450 degrees.

In the form of the mounting of the shaped member 12, as shown in fig. 1 to 5, with reference to one embodiment, the shaped member 12 is removably inserted into the distal portion of the tubular body 11 through the delivery passage 118.

During the ablation process of the cryoablation catheter 10, the distal end 111 of the tube 11 is inserted into the vicinity of the lesion, and then the shaping member 12 is inserted into the output channel 118 and enters the distal end portion of the tube 11 along the output channel 118, and the shaping member 12 returns to the original shape in the in vivo environment, for example, a spiral shape and drives the distal end portion of the tube 11 to shape.

The first embodiment is as follows:

in the positional relationship between the input passage 117 and the output passage 118, referring to an embodiment, as shown in fig. 3, the pipe body 11 includes an outer pipe 113 and a first inner pipe 114 located inside the outer pipe 113, the input passage 117 is located in the first inner pipe 114, the output passage 118 is located in a gap between the first inner pipe 114 and the outer pipe 113, and the injection hole 1141 is opened in a pipe wall of the first inner pipe 114.

The cooling medium in the input passage 117 flows out to the output passage 118 from the injection holes 1141, and a cooling medium circuit is formed between the input passage 117 and the output passage 118. The first inner pipe 114 is positioned inside the outer pipe 113, and the cooling medium in the output passage 118 is positioned outside the first inner pipe 114, so that the energy loss of the cooling medium in the input passage 117 can be reduced.

The axis of the outer tube 113 is substantially parallel to the axis of the first inner tube 114, so that the input channel 117 and the output channel 118 extend in parallel along the length of the tube 11.

The radial cross-sectional shape of the outer tube 113 is substantially circular. In other embodiments, the radial cross-sectional shape of the outer tube 113 may be an ellipse, and the radial cross-sectional shape of the outer tube 113 may be adjusted according to actual circumstances.

Likewise, the radial cross-sectional shape of the first inner tube 114 is substantially circular. In other embodiments, the radial cross-sectional shape of the first inner tube 114 may be an ellipse, and the radial cross-sectional shape of the first inner tube 114 may be adjusted according to actual circumstances.

In another embodiment, the outer tube 113 and the first inner tube 114 are separated from each other. In order to avoid relative misalignment of the first inner tube 114 within the outer tube 113, the first inner tube 114 interferes with the shaping member 12. In the present embodiment, the outer wall of the first inner tube 114 and the inner wall of the outer tube 113 are bonded and fixed (for example, by hot melting or gluing), and the mutual fixation of the first inner tube 114 and the outer tube 113 can ensure that the orientation of the injection hole 1141 is fixed when the cooling medium flows out from the injection hole 1141.

In order to facilitate the fixation of the first inner tube 114 and the outer tube 113, in one embodiment, a double lumen tube is integrally formed between the outer tube 113 and the first inner tube 114.

In another embodiment, the cryoablation catheter 10 further comprises a pulling member 13, the pulling member 13 extending from the distal end 111 to at least the proximal end 112, the tubular body 11 further having an operation channel 119 therein; the shaped element 12 and the pulling element 13 are arranged side by side in the operating channel 119 and are fixed to each other in proximity to the distal end of the tubular body 11.

In the ablation process of the cryoablation catheter 10, the distal end 111 of the catheter body 11 needs to be firstly extended into the vicinity of a lesion, and then the position of the distal end 111 of the catheter body 11 can be adjusted through the traction piece 13, so that the distal end of the catheter body 11 can be bent in a wider range.

The pulling element 13 is in the form of a thread, the pulling element 13 extending from a proximal end 112 to a distal end 111, the end of the pulling element 13 being fixed to the end of the shape-imparting element 12 by bolting.

When the pulling member 13 bends at the distal end of the tube 11, the inner wall of the operation channel 119 supports the pulling member 13, and in order to prevent the pulling member 13 from shearing the inner wall of the operation channel 119, referring to an embodiment, as shown in fig. 3 and 5, the cryoablation catheter 10 further includes a coil spring 14 and an inner sleeve 15 disposed in the operation channel 119, the inner sleeve 15 extends from the distal end 111 to the proximal end 112, the coil spring 14 is disposed in the inner sleeve 15, and the shape-determining member 12 and the pulling member 13 are disposed in the coil spring 14.

When the pulling piece 13 pulls the spiral part to bend, the inner wall of the spiral spring 14 can support the pulling piece 13, and the inner sleeve 15 supports the pulling piece 13. Meanwhile, the coil spring 14 can be matched with the shaping piece to keep the shape of the far end part of the tube body 11.

The length of the coil spring 14 is at least longer than the length of the shaping segment 116 along the axial length of the tubular body 11.

The inner sleeve 15 can perform other functions besides the function of constraining and isolating, and in reference to an embodiment, the inner wall of the inner sleeve 15 is provided with a lubricating layer or the inner sleeve 15 is made of a lubricating material. The realization of lubrication can reduce the motion resistance of traction piece 13, improves the holistic operation experience of cryoablation pipe 10, also can reduce wearing and tearing simultaneously, promotes stability.

In terms of the selection of the specific material of the inner sleeve 15, in reference to an embodiment, the inner sleeve 15 is a heat-shrinkable material, and after heat-shrinking, the coil spring 14 and the pulling member 13 are tightened. Specifically, the heat shrinkable material may be a PTFE heat shrinkable film, and the length of the inner sleeve 15 is the same as or slightly shorter than the axial length of the tube 11. In this embodiment, the preassembly of the helical spring 14 and the pulling means 13 can be achieved by heat-shrinking the inner sleeve 15, so that the subsequent assembly is facilitated.

In another embodiment, as shown in FIG. 3, the cryoablation catheter 10 further includes a second inner tube 115, the operation channel 119 being located in the second inner tube 115, the first inner tube 114 and the second inner tube 115 being arranged side by side within the outer tube 113, and the output channel 118 being located in the gap between the outer tube 113 and the inner tubes.

The second inner pipe 115 can prevent various components in the operation passage 119 from interfering with the flow of the cooling medium.

The radial cross-sectional shape of the second inner tube 115 is substantially circular. In other embodiments, the radial cross-sectional shape of the second inner tube 115 may be an ellipse, and the radial cross-sectional shape of the first inner tube 114 may be adjusted according to actual circumstances.

In the relationship of the positions of the outer tube 113, the first inner tube 114 and the second inner tube 115, referring to an embodiment, a central connecting line of the first inner tube 114 and the second inner tube 115 passes through or is offset from the center of the outer tube 113. In the present embodiment, a central connecting line of the first inner tube 114 and the second inner tube 115 passes through the center of the outer tube 113, the first inner tube 114 and the second inner tube 115 are respectively located at two sides of the center of the outer tube 113, and the first inner tube 114 and the second inner tube 115 are in contact or clearance fit with each other.

In another embodiment, the second inner tube 115 and the outer tube 113 are separated from each other. In order to avoid the relative displacement of the second inner tube 115 within the outer tube 113, in the present embodiment, the outer wall of the second inner tube 115 and the inner wall of the outer tube 113 are bonded and fixed (for example, by hot melting, gluing, or the like). The positions of the second inner tube 115 and the outer tube 113 are relatively fixed, so that the orientation of the injection holes 1141 is fixed when the cooling medium flows out from the injection holes 1141.

In order to fix the position between the second inner tube 115 and the outer tube 113, referring to an embodiment, a triple-lumen tube with an integrated structure is adopted among the outer tube 113, the first inner tube 114, and the second inner tube 115.

The above embodiments are disclosed in the above first embodiment, and according to the above embodiments, the present application further provides a second embodiment, which is different from the first embodiment in that the input channel 117 is opened in the shape-fixing member 12.

As shown in fig. 6 to 8, the shaping member 12 has an input passage 117, an output passage 118 for outputting the cooling medium is formed in a gap between the pipe body 11 and the shaping member 12, and the shaping member 12 has an injection hole 1141 communicating the input passage 117 and the output passage 118 at a distal end portion of the pipe body 11.

A cooling medium loop is formed between the input channel 117 and the output channel 118, and after entering the input channel 117, the cooling medium enters the output channel 118 through the injection holes 1141 and is finally discharged from the output channel 118. Because the input channel 117 is located in the shaping member 12, the tube diameter of the cryoablation catheter 10 can be reduced, so that the tube body 11 can extend into a thinner bronchus for ablation, and more application scenarios can be adapted.

In another embodiment, as shown in fig. 6 and 7, the shaping member 12 is a nitinol tube having an input channel 117 formed therein. The nitinol tube is shaped into a desired initial state by heat, and during the ablation process of the cryoablation catheter 10, the distal end 111 of the tube body 11 needs to be inserted into the vicinity of the lesion, and at this time, the nitinol tube can be restored to the initial state in the environment of the human body, for example, in a spiral shape, and the distal end of the tube body 11 is driven to be shaped.

The radial cross-sectional shape of the nitinol tube is substantially circular. In other embodiments, the radial cross-sectional shape of the nickel-titanium tube may be an ellipse, and the radial cross-sectional shape of the nickel-titanium tube may be adjusted according to actual circumstances.

The axis of the nitinol tube is arranged substantially parallel to the axis of the body 11 so that both the inlet channel 117 and the outlet channel 118 extend parallel to the length of the body 11.

In another embodiment, as shown in fig. 7, in order to avoid the tube wall of the tube 11 from shielding the injection holes 1141, the injection holes 1141 may extend in a direction substantially parallel to the center line of the spiral.

In another embodiment, as shown, the cryoablation catheter 10 further includes a pulling member 13, the pulling member 13 extending from the distal end 111 to at least the proximal end 112, the pulling member 13 and the shaping member 12 being arranged side-by-side within the delivery channel 118 and secured to each other adjacent the distal end of the tube 11.

The pulling element 13 is in the form of a thread, and the ends of the pulling element 13 and the ends of the shape-defining element 12 can be fixed by bolting.

In order to prevent the pulling member 13 from shearing the inner wall of the tube 11 when the pulling member 13 pulls the distal end portion of the tube 11 to bend, referring to an embodiment, as shown in fig. 6 and 8, the cryoablation catheter 10 further includes a coil spring 14 disposed inside the tube 11, the shape-determining member 12 and the pulling member 13 are disposed through the coil spring 14, and the inner wall of the coil spring 14 supports the pulling member 13 when the pulling member 13 pulls the spiral portion to bend. Meanwhile, the coil spring 14 can be matched with the shaping piece to keep the shape of the far end part of the tube body 11.

In order to avoid the coil spring 14 from shielding the injection hole 1141, referring to an embodiment, the coil spring 14 has a reed dredging section 141, the reed dredging section 141 is located in the shaping section 116, and the reed dredging section 141 has a certain pitch, and the cooling medium can flow out through the pitch gap. In the present embodiment, the pitch of the relief spring section 141 is greater than or equal to the flow aperture of the injection hole 1141.

In another embodiment, the length of the unsprung section 141 is at least longer than the length of the shaped section 116 along the axial length of the tubular body 11.

As shown in fig. 9, the present application also provides a cryoablation device 100 including a catheter, which may be the cryoablation catheter 10 of the above embodiments, and an operating handle 20 connected to a proximal portion of the catheter.

The operator drives the cryoablation catheter 10 to extend to the vicinity of the lesion by holding the operation handle 20, and then the lesion part is ablated by the cryoablation catheter 10, so that the operator can conveniently operate the cryoablation catheter 10.

As shown in fig. 10 to 15, in another embodiment, the operating handle 20 includes a housing 21, an input connector 22, an output connector 23, and a bending adjustment assembly 27, wherein the input connector 22, the output connector 23, and the bending adjustment assembly 27 are all mounted on the housing 21;

the housing 21 is fixedly connected to the proximal end portion of the tube 11, the input connector 22 is communicated with the input channel 117, the output connector 23 is communicated with the output channel 118, and the bending adjusting component 27 is connected with the traction member 13 and can drive the traction member 13 to move so as to drive the catheter to bend.

The cooling medium is fed into the feed channel 117 via the feed connection 22 and the medium in the discharge channel 118 is discharged via the discharge connection 23. The operator drives the cryoablation catheter 10 to extend into the focus through the operating handle 20, and drives the catheter to bend through the bending adjusting component 27, so that the far-end part of the catheter avoids the tissue and the organ, and the damage to the tissue and the organ is reduced.

The housing 21 has a mounting cavity 213 and a mounting hole (not shown) communicating with the mounting cavity 213, and the proximal end portion of the tube 11 passes through the mounting hole and extends to the mounting cavity 213.

The housing 21 is tubular and provides support for the various components while also providing room for an operator to hold. For the convenience of processing and assembling the housing 21, referring to an embodiment, as shown in the figure, the housing 21 includes a first supporting shell 211 and a second supporting shell 212, and the first supporting shell 211 and the second supporting shell 212 are mutually buckled to form a mounting cavity 213. The radial cross section of the mounting cavity 213 is substantially circular, but in other embodiments, the radial cross section of the mounting cavity 213 may be elliptical.

When the cryoablation device 100 is used with the cryoablation catheter 10 of the first embodiment, referring to an embodiment, as shown in fig. 10a, the proximal end of the first inner tube 114 is disposed between the input connector 22 and the output connector 23 along the axial direction of the catheter body and is sealed by the first sealing member 28, and the proximal end of the output channel 118 is sealed by the second sealing member 29.

When the cryoablation device 100 employs the cryoablation catheter 10 of the second embodiment, referring to an embodiment, as shown in fig. 10b, a first sealing member 28 and a second sealing member 29 are sequentially disposed inside the proximal portion of the tube 11 along the axial direction of the tube, the shaping member 12 is sealed through the first sealing member 28, and the end portion of the shaping member 12 is disposed between the first sealing member 28 and the second sealing member 29, so that the input channel 117 is opened between the first sealing member 28 and the second sealing member 29, and then the traction member 13 is sealed through the second sealing member 29 and extends to the bending adjustment assembly 27.

The input joint 22 and the output joint 23 are both tubular and have joint channels 24, each joint channel 24 is respectively communicated with the input channel 117 and the output channel 118 in a one-to-one correspondence manner, and the extending direction of each joint channel 24 is approximately oblique or perpendicular to the axis of the pipe body 11.

In the way of mounting the input connector 22 and the output connector 23 to the housing 21, referring to an embodiment, the housing 21 has two fixing holes (not labeled), and each connector extends out of the housing 21 from the corresponding fixing hole and is connected to a luer connector (not shown). The extending direction of each fixing hole is approximately oblique or perpendicular to the axis of the pipe body 11, so that when each joint is located in the corresponding mounting hole, the pipe body 11 can be axially fixed.

In order to make the structure of the operating handle 20 compact, in one embodiment, the extending directions of the fixing holes are parallel to each other.

The above connectors include an input connector 22 and an output connector 23.

In the way of installing the input connector 22 and the output connector 23 with the pipe 11, referring to an embodiment, the input connector 22 and the output connector 23 are respectively provided with a connecting sleeve 25, and the opening of each connector channel 24 is opened on the side wall of the corresponding connecting sleeve 25. The pipe body 11 is located in each connecting sleeve 25 and fixed to each other by hot melting, gluing, etc., and the opening of each joint channel 24 is communicated with the corresponding communicating opening.

The connecting sleeves 25 are integrated or separated. In the present embodiment, the connecting sleeves 25 are integrally arranged.

In order to support the proximal end 112 of the tube 11 and avoid mutual misalignment of the tube 11 in the mounting cavity 213 during operation, in an embodiment, the connecting sleeve 25 is provided with a ring-shaped supporting member 26 near the sidewall of the proximal end 112, and the outer sidewall of the supporting member 26 is attached to the inner wall of the mounting cavity 213. Alternatively, in other present embodiments, the number of the supporting pieces 26 is two, two supporting pieces 26 are arranged in sequence along the axial direction of the connecting sleeve 25, and a part of the housing 21 extends to between the two supporting pieces 26.

In another embodiment, the bending adjustment assembly 27 includes a driven member 271 and a driving member 272, the housing 21 defines a guide groove 214 extending along the axial direction of the guide tube;

the follower 271 has a linkage part 273 extending along its own radial direction, the follower 271 is movably mounted in the housing 21, the linkage part 273 extends out of the guide groove 214, the follower 271 is connected with the traction member 13;

the driving member 272 is sleeved on the housing 21 and is in threaded fit with the linkage portion 273, and the driving member 272 rotates relative to the housing 21 and drives the driven member 271 to move in the rotating process so as to drive the conduit to bend.

The operator rotates the driving member 272, and the driving member 272 drives the driven member 271 to move along the axis direction of the catheter, so that the traction member 13 drives the catheter to bend, and the distal end of the catheter body 11 avoids the tissue and organ, thereby reducing the damage to the tissue and organ.

The driver 272 has an adjustment groove 274 of the socket housing 21, and an inner wall of the adjustment groove 274 is screw-engaged with the link 273. The drive member 272 is generally cylindrical and the drive member 272 may be made of a metallic or medical grade plastic.

The shape of the radial section of the follower 271 along the installation cavity 213 is substantially the same as the shape of the radial section of the installation cavity 213 itself, and the outer side wall of the follower 271 is attached to the inner side wall of the installation cavity 213, so as to prevent the follower 271 from shaking in the radial direction of the conduit. In the present embodiment, the follower 271 has a substantially cylindrical shape.

In order to make the operation of the follower 271 more stable, referring to an embodiment, the number of the interlocking portions 273 is two, and two interlocking portions 273 are disposed at both sides of the follower 271.

In order to facilitate the connection between the pulling member 13 and the driven member 271, in the connection between the pulling member 13 and the driven member 271, referring to an embodiment, as shown in the figure, a through hole 275 extending along the axial direction of the conduit is formed in the middle of the driven member 271, the driven member 271 has a pin 276 extending into the through hole 275, and the pulling member 13 extends into the through hole 275 and is bolted to the pin 276.

The pulling member 13 is further provided with a pin hole (shown as a mark) communicated with the through hole 275, and the pin shaft 276 penetrates through the pin hole and extends into the through hole 275. Wherein the extension direction of the pin hole is oblique or perpendicular to the extension direction of the through hole 275.

In the form of the threaded engagement of the interlocking portion 273 with the driver 272, referring to an embodiment in which the driver 272 is provided with a rectangular internal thread, the length of the interlocking portion 273 in the direction of the axis of the catheter is substantially equal to the pitch of the internal thread, and the interlocking portion 273 is located between two adjacent threads of the internal thread.

Each of the linkage portions 273 has a substantially columnar shape, a diameter of the columnar shape is substantially equal to a pitch of the female screw, and an axis of the linkage portion 273 is oblique or perpendicular to an axis of the follower 271.

To avoid slippage between the operator and the driving member 272 while the operator holds the driving member 272, referring to an embodiment, the driving member 272 is provided with an anti-slip member 277 on an outer wall thereof. In the present embodiment, the anti-slip device 277 is an anti-slip pattern, an anti-slip protrusion, a rubber sheet, or the like.

In another embodiment, as shown in the drawings, the cryoablation device 100 further includes a stress dispersion member 30 located at the joint between the housing 21 and the tube 11 and fixed to the housing 21, the stress dispersion member 30 is sleeved on the outer side of the tube 11, and during the bending process of the tube 11, the stress dispersion member 30 bends along with the tube 11 and provides a buffer.

The stress dispersion member 30 has a mounting passage 31 for the pipe body 11 to pass through, and the mounting passage 31 extends in a direction substantially coincident with the axis of the pipe body 11.

In another embodiment, the stress splitter 30 has a connecting section 32 and an extending section 33, wherein the connecting section 32 is located in the first mounting hole of the housing 21 and is fixedly connected to the housing 21, and the extending section 33 extends toward the distal end 111. The connecting section 32 is tubular, and the cavity in the connecting section 32 is the mounting channel 31.

The extension 33 has a gradually decreasing rigidity from the proximal end 112 to the distal end 111. referring to an embodiment, the wall thickness of the extension 33 gradually decreases from one end of the connecting segment 32 to the other end.

In order to fix the connecting section 32 to the housing 21, referring to an embodiment, as shown in the figure, a limiting shoulder 34 is disposed on an outer side wall of the connecting section 32, and a limiting groove matched with the limiting shoulder 34 is formed on a side wall of the mounting cavity 213. The stop shoulder 34 not only positions the mounting position of the connecting section 32 in the housing 21, but also enables the pre-mounting of the stress splitter 30 in the housing 21.

In order to make the connection of the stress dispersion member 30 to the housing 21 more firm. Referring to an embodiment, the number of the position-limiting shoulders 34 is multiple, and the multiple position-limiting shoulders 34 are arranged at intervals along the axis of the installation channel 31. In the present embodiment, the number of the position-limiting shoulders 34 may be 1, 2, 3, or 3 or more, and the number of the position-limiting shoulders 34 may be adjusted as needed or adjusted according to the length of the connecting section 32.

The technical features of the above embodiments can be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the above embodiments are not described, but should be considered as the scope of the present specification as long as there is no contradiction between the combinations of the technical features. When technical features in different embodiments are represented in the same drawing, it can be seen that the drawing also discloses a combination of the embodiments concerned.

The above examples only express several embodiments of the present application, and the description thereof is more specific and detailed, but not construed as limiting the claims. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the concept of the present application, which falls within the scope of protection of the present application.

Claims

1. A cryoablation catheter comprising a body having opposite distal and proximal ends, wherein the body has an inlet channel and an outlet channel for delivery of a cooling medium, the inlet and outlet channels being in communication at the distal end of the body through an injection orifice;

2. The cryoablation catheter of claim 1, wherein the input channel is located inside the spiral shape relative to the output channel, and the jet holes are directed outside the spiral shape.

3. The cryoablation catheter of claim 1 or 2, wherein the catheter body comprises an outer tube and a first inner tube within the outer tube, the input channel being located in the first inner tube, the output channel being located in a gap between the first inner tube and the outer tube, the injection holes opening into a wall of the first inner tube.

4. The cryoablation catheter of claim 3 further comprising a pulling member extending from a distal end to at least a proximal end, the catheter body further including an operative channel therein;

5. The cryoablation catheter as recited in claim 4 further comprising a coil spring and an inner sleeve disposed through the operative channel, the inner sleeve extending from a distal end to a proximal end, the coil spring disposed through the inner sleeve, the shape-defining member and the pulling member disposed through the coil spring.

6. The cryoablation catheter of claim 5 further comprising a second inner tube, wherein the operating channel is located in the second inner tube, the first and second inner tubes are arranged side-by-side within an outer tube, and wherein the output channel is located in a gap between the outer tube and the inner tubes.

7. The catheter of claim 1, wherein the shape member has the inlet passage, a gap between the tube body and the shape member forms an outlet passage for discharging a cooling medium, and the shape member has the injection hole formed at a distal end portion of the tube body to communicate the inlet passage with the outlet passage.

8. A cryoablation device comprising a catheter and an operating handle connected to the proximal end of the catheter, wherein the cryoablation catheter is the cryoablation catheter according to any one of claims 4-6.

9. The cryoablation device of claim 8, wherein the operating handle comprises a housing, an input connector, an output connector, and a bend adjustment assembly, the input connector, the output connector, and the bend adjustment assembly all mounted to the housing;

10. The cryoablation device of claim 9, wherein the bend adjustment assembly comprises a driven member and a driving member, and the housing defines a guide slot extending axially along the catheter;