CRYOABLATION CATHETER AND SYSTEM

Abstract

The disclosure relates to a cryoablation catheter and a cryoablation system. The cryoablation catheter comprises a catheter body and a freezing unit. The catheter body comprises a cold-source fluid input lumen and a cold-source fluid output lumen, both extending in an axial direction of the catheter body, and the freezing unit is arranged at a distal portion of the catheter body, and comprises a first balloon in fluid communication with the cold-source fluid input lumen and the cold-source fluid output lumen, and a second balloon arranged external to the first balloon with the length of the first balloon being less than the length of the second balloon. When the first balloon and the second balloon are dilated, a cavity is formed between the first balloon and the second balloon, to prevent the energy transfer in a space of the freezing unit corresponding to the cavity.

Claims

1-18. (canceled)

19. A cryoablation catheter comprising: a catheter body, the catheter body comprising a cold-source fluid input lumen and a cold-source fluid output lumen both extending in an axial direction of the catheter body; and a freezing unit arranged at a distal portion of the catheter body, the freezing unit comprising a first balloon in fluid communication with the cold-source fluid input lumen and the cold-source fluid output lumen, and a second balloon arranged external to the first balloon, with the length of the first balloon being less than the length of the second balloon, an area between the first balloon and the second balloon is a sealed space, a part of wall of the first balloon and a part of wall of the second balloon are fitted, and the joint portion of the walls of the first balloon and of the second balloon is a channel for transferring freezing energy to a treatment position, when the first balloon and the second balloon are dilated, a cavity for avoiding energy transfer is formed between the first balloon and the second balloon, to prevent energy transfer in the space of the freezing unit corresponding to the cavity.

20. The cryoablation catheter according to claim 19, wherein the cavity is pre-filled with a heat insulation fluid, so as to block energy transfer inside the cavity.

21. The cryoablation catheter according to claim 19, wherein a supporting structure is provided between the first balloon and the second balloon, and when the first balloon and the second balloon are dilated, the supporting structure is able to support the cavity for avoiding energy transfer formed between the first balloon and the second balloon.

22. The cryoablation catheter according to claim 21, wherein the supporting structure is a balloon, the catheter body further comprises a balloon filling lumen extending in an axial direction of the catheter body, and the balloon filling lumen is in fluid communication with the balloon.

23. The cryoablation catheter according to claim 21, wherein the supporting structure is made of one or more shape-memory-alloy wires having a preset shape, and the shape-memory-alloy wires are arranged between the first balloon and the second balloon.

24. The cryoablation catheter according to claim 21, wherein the supporting structure is a protrusion arranged on the first balloon.

25. The cryoablation catheter according to claim 21, wherein the supporting structure is a wrinkle set in at least one of a proximal end and a distal end of the first balloon.

26. The cryoablation catheter according to claim 25, wherein the wrinkle is formed by directly stacking the first balloon.

27. The cryoablation catheter according to claim 21, wherein the supporting structure is formed by a plurality of ribbon-like structures, two ends of the ribbon-like structures are individually fixedly connected to two ends of the second balloon, and when the first balloon and the second balloon are dilated, the ribbon-like structures are tightened, thereby forming the cavity for avoiding energy transfer between the first balloon and the second balloon.

28. The cryoablation catheter according to claim 21, wherein the supporting structure is formed by a plurality of wire-like structures, two ends of the wire-like structures are individually fixedly connected to two ends of the second balloon, and when the first balloon and the second balloon are dilated, the wire-like structures are tightened, thereby forming the cavity for avoiding energy transfer between the first balloon and the second balloon.

29. The cryoablation catheter according to claim 21, wherein the cavity is pumped to negative pressure in advance, thereby preventing energy transfer.

30. A cryoablation system comprising: a cryoablation catheter, the cryoablation catheter comprising a catheter body and a freezing unit arranged at a distal portion of the catheter body, and the catheter body comprises a cold-source fluid input lumen, a cold-source fluid output lumen and a filling and sucking lumen those extend in an axial direction of the catheter body; and the freezing unit comprises a first balloon in fluid communication with the cold-source fluid input lumen and the cold-source fluid output lumen, and a second balloon arranged external to the first balloon, and the second balloon is in communication with the filling and sucking lumen, the length of the first balloon is less than the length of the second balloon, a part of wall of the first balloon and a part of wall of the second balloon are fitted, and the joint portion of the walls of the first balloon and of the second balloon is a channel for transferring freezing energy to a treatment position; and a cryoablation device, the cryoablation device comprising a heat insulation module and a second thawing module that are in communication with the filling and sucking lumen, a freezing module that is in communication with the cold-source fluid input lumen and the cold-source fluid output lumen, a first thawing module that is in communication with the cold-source fluid input lumen, and a controlling system that controls parameters of the heat insulation module, the freezing module, the first thawing module and the second thawing module, in a cryoablation stage, freezing energy in the freezing module is transferred into the first balloon via the cold-source fluid input lumen, to dilate the first balloon and the second balloon; and the cryoablation system fills the second balloon with a heat insulation medium or sucks the second balloon by using the heat insulation module, to cause the cavity for avoiding energy transfer formed between the first balloon and the second balloon to be filled with the heat insulation medium or be pumped to a negative-pressure state, to prevent the freezing energy from being transferred via the cavity, and in a thawing stage, the first thawing module and the second thawing module fill a thawing fluid into the first balloon and the second balloon via the cold-source fluid input lumen and the filling and sucking lumen respectively, to enable the freezing unit to be thawed rapidly.

31. The cryoablation system according to claim 30, wherein the heat insulation module is a filling pump.

32. The cryoablation system according to claim 30, wherein the heat insulation module is a vacuum pump.

33. The cryoablation system according to claim 32, wherein a supporting structure is arranged between the first balloon and the second balloon, and when the first balloon is dilated, and the supporting structure can support the cavity for avoiding energy transfer, to enable a shape of the cavity for avoiding energy transfer to be stable and reliable.

34. The cryoablation system according to claim 33, wherein the supporting structure is a balloon, the catheter body further comprises a balloon filling lumen extending in an axial direction of the catheter body, and the balloon filling lumen is in fluid communication with the balloon.

35. The cryoablation system according to claim 33, wherein the supporting structure is made of one or more shape-memory-alloy wires having a preset shape, one end of the supporting structure is connected to a pushing handle, and when the first balloon has been delivered to a lesion site, the supporting structure is pushed between the first balloon and the second balloon by using the pushing handle.

36. The cryoablation system according to claim 33, wherein the supporting structure is formed by a plurality of ribbon-like structures, both ends of the ribbon-like structures are fixedly connected to two ends of the second balloon respectively, and when the first balloon and the second balloon are dilated, the ribbon-like structures are tightened, thereby forming the cavity for avoiding energy transfer between the first balloon and the second balloon.

37. The cryoablation system according to claim 33, wherein the supporting structure is formed by a plurality of wire-like structures, both ends of the wire-like structures are fixedly connected to two ends of the second balloon respectively, and when the first balloon and the second balloon are dilated, the wire-like structures are tightened, thereby forming the cavity for avoiding energy transfer between the first balloon and the second balloon.

38. The cryoablation system according to claim 33, wherein the supporting structure is a wrinkle set in at least one of a proximal end and a distal end of the first balloon.

Description

DETAILED DESCRIPTION OF THE DRAWINGS

[0051] FIG. 1 is a schematic diagram of the overall structure of the cryoablation catheter of the present application.

[0052] FIG. 2 is a schematic diagram of the first embodiment of the cryoablation catheter having the supporting structure of the present application.

[0053] FIG. 3 is a schematic diagram of the second embodiment of the cryoablation catheter having the supporting structure of the present application.

[0054] FIG. 4 is a schematic diagram of the third embodiment of the cryoablation catheter having the supporting structure of the present application.

[0055] FIG. 5 is a schematic diagram of the fourth embodiment of the cryoablation catheter having the supporting structure of the present application.

[0056] FIG. 6A is a schematic diagram of the fifth embodiment of the cryoablation catheter having the supporting structure of the present application, and FIG. 6B is a schematic diagram of the section A-A of FIG. 6A.

[0057] FIG. 7A is a schematic diagram of the sixth embodiment of the cryoablation catheter having the supporting structure of the present application, and FIG. 7B is a schematic diagram of the section B-B of FIG. 7A.

[0058] FIG. 8A is a schematic diagram of the seventh embodiment of the cryoablation catheter having the supporting structure of the present application, and Fig. B is a schematic diagram of the section C-C of FIG. 8A.

[0059] FIG. 9A is a schematic diagram of the overall structure of the cryoablation catheter having the filling and sucking lumen of the present application, and FIG. 9B is a schematic diagram of the section D-D of the catheter body of FIG. 9A.

[0060] FIG. 10 is a schematic diagram of the overall structure of the cryoablation system of the present application.

[0061] FIG. 11 is a schematic diagram of the first embodiment of the cryoablation catheter having the supporting structure of the present application.

[0062] FIG. 12A is a schematic diagram of the second embodiment of the cryoablation catheter having the supporting structure of the present application, and FIG. 12B is a schematic diagram of the section E-E of FIG. 12A.

[0063] FIG. 13A is a schematic diagram of the third embodiment of the cryoablation catheter having the supporting structure of the present application, and FIG. 13B is a schematic diagram of the section F-F of FIG. 13A.

[0064] FIG. 14A is a schematic diagram of the fourth embodiment of the cryoablation catheter having the supporting structure of the present application, and FIG. 14B is a schematic diagram of the section G-G of FIG. 14A.

[0065] FIG. 15 is a schematic diagram of the fifth embodiment of the cryoablation catheter having the supporting structure of the present application.

[0066] FIG. 16 is a schematic diagram of the supporting structure having preset umbrella shape of the cryoablation catheter of the present application.

[0067] In the drawings, 1 is the cold-source connector, 2 is the manipulating handle, 3 is the freezing unit, 4 is the flexible connecting pipe, 5 is the catheter body, 6 is the cavity for avoiding energy transfer, 21 is the steerable unit, 22 is the guidewire-lumen manipulating unit, 23 is the port of the balloon filling lumen, 31 is the first balloon, 32 is the second balloon, 33 is the supporting structure, 331 is the balloon, 332 is the shape-memory-alloy wires, 333 is the protrusion, 334 is the wrinkle, 335 is the ribbon-like or wire-like structures, 51 is the cold-source fluid input lumen, 52 is the cold-source fluid output lumen, 53 is the filling and sucking lumen, 54 is the balloon filling lumen, 55 is the tip, 56 is the guidewire lumen tube, 57 is the second vacuum lumen, 58 is the pushing rod, 531 is the filling and sucking port, 101 is the heat insulation module, 102 is the first thawing module, 102 is the second thawing module, 103 is the freezing module, and 104 is the controlling system.

DETAILED DESCRIPTION

[0068] In order to make the purposes, the technical solutions and the advantages of the present application more clear, the present application will be described in detail below by referring to the drawings and the embodiments.

[0069] In the present application, proximal end refers to the end that is closer to the surgery operator, and distal end refers to the end that is further away from the surgery operator.

The First Embodiment

[0070] As shown in FIG. 1, the cryoablation catheter of the present application comprises: a cold-source connector 1, a manipulating handle 2, a freezing unit 3, a flexible connecting pipe 4 and a catheter body 5. The catheter body 5 having a distal end and a proximal end comprises a cold-source fluid input lumen 51 and a cold-source fluid output lumen 52 both extending in an axial direction of the catheter body 5. The freezing unit 3 is arranged at the distal portion of the catheter body 5, and comprises a first balloon 31 that is in fluid communication with the cold-source fluid input lumen 51 and the cold-source fluid output lumen 52, and a second balloon 32 that is arranged external to the first balloon 31. The second balloon 32 dilates along with the first balloon 31. The length of the first balloon 31 is less than the length of the second balloon 32. A part of the wall of the first balloon 31 and a part of the wall of the second balloon 32 are fitted. The joint portion of the walls of the first balloon 31 and of the second balloon 32 is a channel for transferring the freezing energy to a treatment position. The area between the first balloon 31 and the second balloon 32 is a sealed space, and is pumped to a vacuum state in advance or filled with a certain amount of a heat insulation medium. When the first balloon 31 and the second balloon 32 are dilated, a cavity 6 for avoiding energy transfer is formed between the first balloon 31 and the second balloon 32, so as to prevent the energy transfer in the space of the freezing unit 3 corresponding to the cavity 6.

[0071] For example, pulmonary vein isolation is a surgical method commonly used for treating atrial fibrillation, and the birth of cryoablation catheters enables pulmonary vein isolation to be more simple and convenient. However, because left atrium has a limited space, and the cryoablated site is limited to merely the vestibule of pulmonary vein, it is desirable to concentrate the freezing energy to the forward hemisphere of the balloon. Therefore, the cavity 6 for avoiding energy transfer is arranged at the proximal end of the first balloon 31. In the treatment process, the freezing unit 3 is pushed to the left atrium, and a certain amount of refrigerant is injected into the first balloon 31, whereby the first balloon 31 dilates, and in turn drives the second balloon 32 to dilate. A part of the wall of the first balloon 31 and a part of the wall of the second balloon 32 are fitted. The joint portion of the walls of the first balloon 31 and of the second balloon 32 is a channel for transferring the freezing energy to a treatment position. Because the shapes and the sizes of the first balloon 31 and the second balloon 32 are different, and the cavity 6 for avoiding energy transfer is formed between the first balloon 31 and the second balloon 32, so as to prevent the freezing energy from being transferred to the proximal end of the freezing unit 3. Then the freezing unit 3 is pushed to against to the ostia of pulmonary vein to be ablated, and the cryoablation treatment is started up, then a refrigerant is injected into the first balloon 31, thereby absorbing the heat of the treated area so as to reach the effect of cryoablation.

[0072] The manipulating handle 2 is arranged at the proximal end of the catheter body 5. The manipulating handle 2 is connected to a cold-source connector 1 via a flexible connecting pipe 4. The cold source is transferred into the first balloon 31 via the cold-source connector 1, the flexible connecting pipe 4 and the cold-source fluid input lumen 51 provided within the catheter body 5, to dilate the first balloon 31. In an embodiment, at least one connection plug is arranged at the proximal end of the cold-source connector 1, and the connection plug is connected to a refrigerating device. The distal end of the cold-source connector 1 is connected to the proximal end of the manipulating handle 2 via the flexible connecting pipe 4, and the refrigerating device provides a refrigerant to the cryoablation catheter via the cold-source connector 1.

[0073] In an embodiment, a tip 55 is arranged at the farthest distal end of the catheter body 5. Preferably, the tip 55 is a polymer hose. A guidewire lumen tube 56 is arranged within the catheter body 5, and the tip 55 is fixedly connected to the distal end of the guidewire lumen tube 56 by adhesion or fusion, in order to prevent the cryoablation catheter from damaging blood vessels or tissues during the delivering process. The distal end of the first balloon 31 is fixedly connected to the guidewire lumen tube 56 by processes such as adhesion and welding. The proximal end of the first balloon 31 is fixedly connected to a cold-source circuit by processes such as adhesion and welding. The cold-source circuit comprises the cold-source fluid input lumen 51 and the cold-source fluid output lumen 52. The cold-source circuit may be connected to the refrigerating device via the cold-source connector 1.

[0074] The manipulating handle 2 further comprises a steerable unit 21 and a guidewire lumen manipulating unit 22. The steerable unit 21 controls the movement of the distal end of the tip 55. The freezing unit 3 can easily reach the treatment position by controlling a bending shape of the distal end of the tip 55. The guidewire lumen manipulating unit 22 is fixedly connected to the proximal end of the guidewire lumen tube 56. The guidewire lumen manipulating unit 22 comprises a liquid injecting opening in communication with the lumen of the guidewire lumen tube 56, and through which, if necessary, normal saline, a contrast medium or other liquids can be injected.

[0075] The way the cryoablation catheter of the present application works is as follows. The freezing unit 3 of the cryoablation catheter is pushed into the target-tissue area, then the first balloon 31 is sufficiently filled, and the second balloon 32 is dilated along with the dilation of the first balloon 31. The cavity 6 for avoiding energy transfer is formed between the first balloon 31 and the second balloon 32. The cryoablation catheter is pushed integrally, and the steerable unit 21 is operated, to enable the freezing unit 3 to contact the target tissue. After the above steps have been completed, by operating the refrigerating device, a liquid refrigerant is delivered into the first balloon 31, thereby freezing the target tissue. Because the cavity 6 for avoiding energy transfer is formed between the first balloon 31 and the second balloon 32, heat insulation protection is formed at that area, in order to avoid the peripheral tissue being accidentally injured by the freezing energy.

[0076] In conventional cryoablation surgeries, because of the conduction of the freezing energy, the areas at the periphery of the target tissue are often refrigerated. The action principle of the cryoablation catheter of the present application is to form the cavity 6 for avoiding energy transfer between the first balloon 31 and the second balloon 32, so that the freezing energy does not work on the peripheral areas, thereby forming heat insulation protection. Depending on the particular requirements on the protection of the peripheral tissues of different cryoablation areas in different surgeries, the cavity 6 may also be arranged at the distal end of the first balloon 31, or at both ends of the first balloon 31, or on one side of the first balloon 31. For example, in the cryoablation surgery on atrial fibrillation, the target tissue of cryoablation is the vestibule of the pulmonary vein, and because the front end of the target tissue is adjacent to the phrenic nerve, and the freezing of the phrenic nerve results in phrenic nerve paralysis, therefore, the cavity 6 for avoiding energy transfer may be arranged at the distal end of the freezing unit 3. In the cryoablation surgery of the sympathetic nerve of renal artery, the target tissue of cryoablation is the middle and the distal ends of the renal artery. The distal end of the target tissue is adjacent to the renal pelvis, and freezing of the renal pelvis can cause functional impotence. The proximal end of the target tissue is adjacent to the aorta, and improper freezing of the aorta can also results in relative complications. Therefore, the cavity 6 for avoiding energy transfer may be arranged at both of the distal end and the proximal end of the freezing unit 3. Therefore, the position of the cavity 6 for avoiding energy transfer depends on the types of the surgeries and the tissues to be protected. The cryoablation catheter of the present application has a simple structure, and by providing the cavity 6 for avoiding energy transfer, where the freezing energy cannot be transferred, thereby resulting in a good heat insulation effect, whereby the present application can limit the release area of the freezing energy, reduce the probability of complications, and reduce the cost of treatment. Furthermore, depending on the particular requirements on the protection of the peripheral tissues of different cryoablation areas in different surgeries, the present application can provide one or more cavities 6 for avoiding energy transfer, so as to further reduce the damage of the freezing energy to the peripheral tissue during the surgery, and has wide application.

The Second Embodiment

[0077] The present embodiment differs from the first embodiment in that: a supporting structure is provided between the first balloon 31 and the second balloon 32 where is adjacent to the non-treatment position, and when the first balloon 31 and the second balloon 32 are dilated, the supporting structure is able to support the cavity 6 for avoiding energy transfer formed between the first balloon 31 and the second balloon 32, thereby ensuring that the shape of the cavity 6 for avoiding energy transfer is stable and reliable.

[0078] In an embodiment, the supporting structure 33 is a balloon 331 arranged at the proximal end of the first balloon 31. As shown in FIG. 2, the catheter body 5 further comprises a balloon filling lumen 54 extending in an axial direction of the catheter body 5, and the balloon filling lumen 54 is in fluid communication with the balloon 331. During therapy, firstly a certain amount of refrigerant is injected into the first balloon 31 in order to dilate the first balloon 31 and the second balloon 32. The balloon 331 may be filled by injecting liquid/gas through the balloon filling lumen 54. Because the expansion of the balloon 331 serves to support, the vacuum heat insulation cavity is stable and reliable. Because the cavity 6 is pumped to vacuum in advance or filled with a heat insulation medium, the transferring of the freezing energy to the proximal end of the freezing unit 3 can be prevented. Then, the cryoablation therapy is started up, and a refrigerant is injected into the first balloon 31 to absorb the heat of the treatment region, and then to achieve the effect of cryoablation.

The Third Embodiment

[0079] The present embodiment differs from the second embodiment in that: as shown in FIG. 3, the supporting structure 33 may be made of one or more shape-memory-alloy wires 332 having a preset shape. The supporting structure 33, the first balloon 31 and the second balloon 32 are in a compressed state before reaching the lesion site. When the first balloon 31 has been delivered to the lesion site, the supporting structure 33 can restore the preset shape, thereby performing the supporting. Then, the cryoablation treatment is started up, and the refrigerant is injected into the first balloon 31 to absorb the heat of the treatment region, and then to achieve the effect of cryoablation. The shape-memory-alloy wires are preferably nickel-titanium wires.

[0080] In some preferable embodiments, the preset shape comprises spiral shape (as shown in FIG. 22A), cage shape (as shown in FIG. 3) or umbrella shape (as shown in FIG. 16). The shape-memory-alloy wires are shaped into shapes such as spiral shape, cage shape or umbrella shape by heat treatment.

The Fourth Embodiment

[0081] The present embodiment differs from the second embodiment in that: the supporting structure 33 is a protrusion 333 arranged on the first balloon 31. The protrusion 333 is adjacent to a non-treatment region, and can serve to support action, to facilitate the forming of the cavity. As shown in FIG. 4, the protrusion 333 is of a mastoid shape, or as shown in FIG. 5, the protrusion 333 is of a thread shape. The protrusion 333 is arranged at the proximal end of the first balloon 31, and is integral with the first balloon 31. When the first balloon 31 is dilated, the protrusion 333 separates the proximal end of the first balloon 31 and the proximal end of the second balloon 32, thereby forming the cavity 6 for avoiding energy transfer between the first balloon 31 and the second balloon 32. Because the space between the first balloon 31 and the second balloon 32 is pumped to vacuum in advance or filled with a heat insulation medium, at the moment a heat insulation space is formed at the proximal end of the first balloon 31, to prevent the freezing energy from being transferred to the proximal end of the freezing unit 3. When the freezing unit 3 has reached the site to be ablated, the refrigerant is injected into the first balloon 31 to absorb the heat of the treatment region, and then to achieve the effect of cryoablation.

The Fifth Embodiment

[0082] The present embodiment differs from the second embodiment in that: the supporting structure 33 is a wrinkle 334 arranged at the proximal end and/or the distal end of the first balloon 31. The wrinkle 334 is formed by folding the first balloon 31 and changing the diameter of the first balloon 31. As shown in FIGS. 6A and 6B, the wrinkle is formed by directly stacking the proximal end of the first balloon 31. When the first balloon 31 is regularly folded because of diameter changing, a wrinkle of a certain height will be formed. The wrinkle 334 can serve to support, to prevent the second balloon 32 from touching the first balloon 31, so as to form the cavity 6 for avoiding energy transfer. Because the space between the first balloon 31 and the second balloon 32 is in advance pumped to vacuum or filled with a heat insulation medium, the cavity 6 for avoiding energy transfer prevents the freezing energy from being transferred to the proximal end of the freezing unit 3. When the freezing unit 3 has reached the site to be ablated, a refrigerant is injected into the first balloon 31 to absorb the heat of the treated area, so as to achieve the effect of cryoablation. Certainly, depending on different treatment sites, the wrinkle may also be arranged at the distal end of the first balloon 31.

The Sixth Embodiment

[0083] The present embodiment differs from the second embodiment in that: the supporting structure is formed by a plurality of ribbon-like or wire-like structures 335, both ends of the ribbon-like or wire-like structures 335 are fixedly connected to two ends of the second balloon 32 respectively, and when the first balloon 31 and the second balloon 32 are dilated, the ribbon-like or wire-like structures 335 are tightened to support, thereby forming the cavity 6 for avoiding energy transfer between the first balloon 31 and the second balloon 32.

[0084] As shown in FIGS. 7A and 7B, the supporting structure 33 is a flat polymer ribbon, wherein one end of it is fixed to the distal end of the second balloon 32, the other end of it is fixed to the proximal end of the second balloon 32, and both ends are located at the interior of the second balloon 32. After the first balloon 31 and the second balloon 32 being dilated, the ribbon is straightened, thereby having a certain supporting capacity. At the moment, because the space between the first balloon 31 and the second balloon 32 is in advance pumped to vacuum or filled with a heat insulation medium, the cavity 6 can block the energy transfer. Then, the cryoablation treatment may be started up, and a refrigerant may be injected into the first balloon 31 to absorb the heat of the treatment region, so as to achieve the effect of cryoablation.

[0085] As shown in FIGS. 8A and 8B, the supporting structure is a natural silk, wherein one end of it is fixed to the distal end of the second balloon 32, the other end of it is fixed to the proximal end of the second balloon 32, and both ends are located at the interior of the second balloon 32. After the first balloon 31 and the second balloon 32 being dilated, the natural silk is straightened, thereby having a certain supporting capacity. At the moment, because the space between the first balloon 31 and the second balloon 32 is in advance pumped to vacuum or filled with a heat insulation medium, the cavity 6 can block the energy transfer. Then, the cryoablation treatment may be started up, and a refrigerant may be injected into the first balloon 31 to absorb the heat of the treatment region, so as to achieve the effect of cryoablation.

The Seventh Embodiment

[0086] As shown in FIGS. 9A and 9B, the cryoablation catheter of the present application comprises: a cold-source connector 1, a manipulating handle 2, a freezing unit 3, a flexible connecting pipe 4 and a catheter body 5. The catheter body 5 having a distal end and a proximal end comprises a cold-source fluid input lumen 51, a cold-source fluid output lumen 52 and a filling and sucking lumen 53 those extend in an axial direction of the catheter body 5. A filling and sucking port 531 is arranged at the distal end of the filling and sucking lumen 53. The freezing unit 3 is arranged at the distal portion of the catheter body 5, and comprises a first balloon 31 in fluid communication with the cold-source fluid input lumen 51 and the cold-source fluid output lumen 52, and a second balloon 32 arranged external to the first balloon 31. The second balloon 32 is in fluid communication with the filling and sucking lumen 53. When the first balloon 31 is dilated and the second balloon 32 is pumped to vacuum or filled with a heat insulation medium through the filling and sucking lumen 53, a heat insulation cavity 6 for avoiding energy transfer is formed between the first balloon 31 and the second balloon 32. The length of the first balloon 31 is less than the length of the second balloon 32. A part of wall of the first balloon 31 and a part of wall of the second balloon 32 are fitted. The joint portion of the walls of the first balloon 31 and of the second balloon 32 is a channel for transferring the freezing energy to a treatment position.

[0087] In an embodiment, a supporting structure is arranged between the first balloon 31 and the second balloon 32. When the first balloon 31 and the second balloon 32 are dilated, the supporting structure is able to support the cavity 6 for avoiding energy transfer formed between the first balloon 31 and the second balloon 32. When the second balloon 32 is pumped to vacuum through the filling and sucking lumen 53, the supporting structure can ensure that the second balloon 32 does not collapse, thereby ensuring that the shape of the cavity 6 for avoiding energy transfer is stable and reliable.

The Eighth Embodiment

[0088] As shown in FIG. 10, the cryoablation system of the present application comprises: a cryoablation catheter and a cryoablation device. The cryoablation catheter has the structure as described in the seventh embodiment. The cryoablation device comprises a heat insulation module 101, a first thawing module 102, a second thawing module 102, a freezing module 103 and a controlling system 104. The heat insulation module 101 and the second thawing module 102 are in communication with the filling and sucking lumen 53 respectively. The second thawing module 102 and the heat insulation module 101 are interlocked, wherein at a moment merely one of them can be in operation state. The freezing module 103 is in communication with the cold-source fluid input lumen 51 and the cold-source fluid output lumen 52. The first thawing module 102 is in communication with the cold-source fluid input lumen 51. The freezing module 103 and the first thawing module 102 are interlocked, wherein at a moment merely one of them can be in operation state. The controlling system 104 controls the parameters of the heat insulation module 101, the freezing module 103, the first thawing module 102 and the second thawing module 102.

[0089] In the cryoablation stage, the freezing energy in the freezing module 103 is transferred into the first balloon 31 via the cold-source fluid input lumen 51, to dilate the first balloon 31 and the second balloon 32; and the cryoablation system fills the second balloon 32 with a heat insulation medium or pumps to vacuum the second balloon 32 by using the heat insulation module 101, so that the cavity 6 for avoiding energy transfer formed between the first balloon 31 and the second balloon is filled with the heat insulation medium or is pumped to a negative-pressure state, thereby preventing the freezing energy from being transferred via the cavity 6.

[0090] In the thawing stage, the first thawing module 102 and the second thawing module 102 fill a thawing fluid into the first balloon 31 and the second balloon 32 via the cold-source fluid input lumen 51 and the filling and sucking lumen 53 respectively, to enable the freezing unit 3 to be thawed rapidly. The temperature of the thawing fluid is between 0-45 degrees Celsius.

[0091] In an embodiment, the heat insulation module 101 pumps the second balloon 32 to vacuum through the filling and sucking lumen 53, thereby realizing the heat insulation function. The heat insulation module 101 is a vacuum pump.

[0092] In another embodiment, the heat insulation module 101 fills the heat insulation medium into the second balloon 32 through the filling and sucking lumen 53, thereby realizing the heat insulation function. The heat insulation module 101 is a filling pump.

The Ninth Embodiment

[0093] The present embodiment differs from the eighth embodiment in that: as shown in FIG. 11, the supporting structure 33 is a balloon 331 arranged at the proximal end of the first balloon 31. The catheter body 5 further comprises a balloon filling lumen 54 extending in an axial direction of the catheter body 5, and the balloon filling lumen 54 is in fluid communication with the balloon 331. During therapy, firstly a certain amount of refrigerant is injected into the first balloon 31, so as to dilate the first balloon 31 and the second balloon 32. The balloon 331 is filled by injecting liquid/gas through the balloon filling lumen 54. The heat insulation module 101 pumps the space between the first balloon 31 and the second balloon 32 to negative pressure or fills the space between the first balloon 31 and the second balloon 32 with a heat insulation medium through the filling and sucking lumen 53 and the filling and sucking port 531. Because the dilation of the balloon 331 serves to support, the heat insulation cavity 6 is stable and reliable, to prevent the freezing energy from being transferred to the proximal end of the freezing unit 3. Then, the cryoablation treatment is started up, and a refrigerant is injected into the first balloon 31 to absorb the heat of the treated area, so as to achieve the effect of cryoablation. In the thawing stage, the second thawing module 102 fills a thawing fluid into the second balloon 32 via the filling and sucking port 531, and at the same time the first thawing unit 102 fills a thawing fluid into the first balloon 31 via the cold-source fluid input lumen 51, to accelerate the thawing of the freezing unit 3.

The Tenth Embodiment

[0094] The present embodiment differs from the eighth embodiment in that: as shown in FIG. 12A, the supporting structure 33 may be made of one or more shape-memory-alloy wires 332 having a preset shape. One end of the supporting structure 33 is connected to a pushing rod 58. When the first balloon 31 has been delivered to the lesion site, the supporting structure 33 is pushed to the proximal end of the first balloon 31 by the pushing rod 58, and is located between the first balloon 31 and the second balloon 32. At the same time the supporting structure 33 restores its preset shape to perform the supporting. FIG. 12B is a schematic diagram of the cross-section of the catheter body 5 of FIG. 12A. As shown in FIG. 12B, the cavity 6 between the first balloon 31 and the second balloon 32 is pumped to negative pressure or filled with a heat insulation medium through the filling and sucking port 531 of the filling and sucking lumen 53, to achieve the energy isolation. Then, the cryoablation treatment may be started up, and a refrigerant may be injected into the first balloon 31 to absorb the heat of the treatment region, to achieve the effect of cryoablation. In the thawing stage, the second thawing module 102 fills a thawing fluid into the second balloon 32 via the filling and sucking port 531 of the filling and sucking lumen 53, and at the same time the first thawing unit 102 fills a thawing fluid into the first balloon 31 via the cold-source fluid input lumen 51, to accelerate the thawing of the freezing unit 3. The shape-memory-alloy wires are preferably nickel-titanium wires. In some preferable embodiments, the preset shape comprises spiral shape, cage shape or umbrella shape. The shape-memory-alloy wires are shaped into shapes such as spiral shape, cage shape or umbrella shape by heat treatment. During the cryoablation catheter is delivered to the lesion site, the supporting structure 33 is compressed within the catheter body 5. When the supporting structure 33 has been pushed by the pushing handle into the space between the first balloon 31 and the second balloon 32, the supporting structure 33 made of the shape-memory-alloy wires 332 restores the reset shape obtained by heat treatment.

The Eleventh Embodiment

[0095] The present embodiment differs from the eighth embodiment in that: the supporting structure is formed by a plurality of ribbon-like or wire-like structures 335, and both ends of the ribbon-like or wire-like structures 335 are fixedly connected to two ends of the second balloon 32 respectively, and when the first balloon 31 is dilated, the ribbon-like or wire-like structures 335 are tightened to provide supporting, thereby forming the cavity 6 for avoiding energy transfer between the first balloon 31 and the second balloon 32.

[0096] As shown in FIGS. 13A and 13B, the supporting structure 33 is a flat polymer ribbon, wherein one end of it is fixed to the distal end of the second balloon 32, the other end of it is fixed to the proximal end of the second balloon 32, and both ends are located at the interior of the second balloon 32. When the first balloon 31 and the second balloon 32 are dilated, the ribbon is straightened, thereby having a certain supporting capacity. At the moment this region is pumped to negative pressure or filled with a heat insulation medium, to form the energy isolation. Then, the cryoablation treatment may be started up, and a refrigerant may be injected into the first balloon 31 to absorb the heat of the treated area, so as to achieve the effect of cryoablation. In the thawing stage, the second thawing module 102 fills a thawing fluid into the second balloon 32 via the filling and sucking port 531, and at the same time the first thawing unit 102 fills a thawing fluid into the first balloon 31 via the cold-source fluid input lumen 51, to accelerate the thawing of the freezing unit 3.

[0097] As shown in FIGS. 14A and 14B, the supporting structure is a natural silk, wherein one end of it is fixed to the distal end of the second balloon 32, the other end of it is fixed to the proximal end of the second balloon 32, and both ends are located at the interior of the second balloon 32. When the first balloon 31 and the second balloon 32 are dilated, the natural silk is straightened, thereby having a certain supporting capacity. At the moment the region is pumped to negative pressure or filled with a heat insulation medium, to form the energy isolation. Then, the cryoablation treatment may be started up, and a refrigerant may be injected into the first balloon 31 to absorb the heat of the treated area, so as to achieve the effect of cryoablation.

[0098] As shown in FIG. 15, the supporting structure 33 is a flat polymer ribbon 335, wherein one end of it is fixed to the distal end of the second balloon 32, the other end of it is fixed to the proximal end of the second balloon 32, and both ends are located at the interior of the second balloon 32. When the first balloon 31 and the second balloon 32 are dilated, the ribbon is straightened, thereby having a certain supporting capacity. The cavity 6 for avoiding energy transfer is formed at both of the distal end and the proximal end of the first balloon 31. At the moment the region is pumped to negative pressure or filled with a heat insulation medium, to prevent the freezing energy from being transferred to the two ends of the freezing unit 3. Then, the cryoablation treatment may be started up, and a refrigerant may be injected into the first balloon 31 to absorb the heat of the treated area, so as to achieve the effect of cryoablation.

[0099] Finally, it should be noted that, the above are merely preferable embodiments of the present application, and are not limiting the present disclosure. Any modifications, equivalent substitutions and improvements that are made within the spirit and principle of the present application should be included in the protection scope of the present application.