Point ablation balloon catheter and calcification lesion treatment device

Abstract

According to the point ablation balloon catheter and the calcification lesion treatment device, multiple sets of ablation electrodes on the point ablation balloon catheter can be controlled in a targeted mode according to the distribution state of a calcification lesion part in a blood vessel. By rotating the rotating seat, the inner tube drives the balloon body turned inwards to be turned outwards, and meanwhile, the ablation electrode on the turned-inwards surface of the balloon body can be turned outwards, so that the ablation electrode can accurately act on a calcified lesion part after the balloon is pressurized subsequently. And in combination with rotation of the rotating seat, the extension length of the inner tube relative to the far end of the cannula can be controlled, so that one group of ablation electrodes or multiple groups of ablation electrodes can be turned outwards according to the specific condition of a diseased region, and the targeted treatment effect is greatly improved.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a point ablation balloon catheter and a calcified lesion treatment device. Background Art

[0002] Coronary heart disease is a common disease worldwide. Vascular calcification can lead to reduced vessel wall compliance, increased stiffness, increased risk of plaque rupture, and easy thrombus formation, ultimately leading to a series of cardiovascular diseases.

[0003] If the diameter of the occluded coronary artery is large, thrombus aspiration can be used directly to restore distal blood flow before placing a stent or pre-dilatation with a balloon. However, high-pressure dilation after stent placement will further crush the thrombus or unstable plaque into fragments, which can easily cause no reflow or slow blood flow.

[0004] In the treatment of calcified lesions, atherectomy and cutting balloons are generally used. Conventional balloons cannot expand hard lesions such as calcification, but cutting balloons may be able to expand satisfactorily. When traditional PTCA fails, cutting balloon technology is used for calcified lesions with fewer complications than atherectomy. However, atherectomy takes more time, is complicated, and has more complications. However, an obvious disadvantage of the cutting balloon is that due to the presence of micro blades, it is harder than traditional balloon catheters and difficult to pass through proximal curved lesions, thereby increasing its failure rate of expansion. In general, the cutting balloon is suitable for mild calcification.

[0005] In recent years, calcium deposits in blood vessels are usually treated by a small surgery, where a catheter equipped with a balloon is inserted into the blood vessel, and the balloon is inflated when it reaches the calcium deposit. The electrodes arranged in the balloon work to release high-voltage pulses, thereby forming shock waves. The shock waves propagate through the fluid and hit the balloon wall and the calcified area, so as to destroy the calcium deposits by the repeated pulses. However, this high-voltage pulse method breaks the calcified tissue under the shock wave and cannot be removed, and the risk of blood circulation is even more serious.

[0006] In summary, the working height of the cutting balloon microblade is only 0.005′, which has little effect on calcified lesions.

[0007] The shock wave balloon releases high-voltage pulses through electrodes, and the electrode position and pulse intensity cannot be adjusted, which can easily cause the risk of blood vessel rupture.

[0008] Moreover, the calcified tissue cannot be removed after it breaks off and flows with the blood to the distal blood vessels, which increases the risk of thrombosis. Summary of the invention

[0009] The purpose of the present application is to provide a point ablation balloon catheter and a calcified lesion treatment device, which can remove the broken and detached calcified tissue and reduce the surgical risk.

[0010] In order to achieve the above-mentioned object, in a first aspect, the present invention provides a point ablation balloon catheter, comprising a sleeve and a balloon catheter, wherein the balloon catheter is inserted into the sleeve;

[0011] The balloon catheter comprises an inner tube, an outer tube and a balloon body, wherein the inner tube is inserted into the inner part of the outer tube, one end of the balloon body is connected to the distal end of the inner tube, and the other end is connected to the distal end of the outer tube, and at least a part of the balloon body is fixedly connected to the distal end of the sleeve, so that the balloon body can be turned inside out and lie on the inner side of the outer tube;

[0012] The proximal end of the balloon catheter is provided with a handle, and the handle is provided with an external thread. The proximal end of the sleeve is connected with an adapter and a rotating seat. The proximal end of the sleeve is fixedly connected to the adapter, and the rotating seat can be relatively rotatably engaged with the adapter, and the handle is threadedly engaged with the rotating seat.

[0013] The proximal end of the outer tube is fixedly connected to the adapter seat, and the inner tube is connected to the handle, so that when the rotating seat is rotated, the inner tube drives the balloon body to extend axially relative to the distal end of the sleeve, and drives the inwardly lying balloon body to turn outward at the same time;

[0014] A plurality of groups of ablation electrodes are arranged on the outer surface of the balloon body, and when the balloon body is inverted and lies on the inner side of the outer tube, the ablation electrodes stay on the inverted surface of the balloon body;

[0015] The multiple groups of ablation electrodes are arranged at intervals in the axial direction of the balloon body and distributed at different circumferential angles of the balloon body.

[0016] In an optional embodiment, the balloon body includes a fixed port and a telescopic port, the fixed port is connected to the distal end of the outer tube, and the telescopic port is connected to the distal end of the inner tube.

[0017] In an optional embodiment, in the original unreleased state, the distal end of the inner tube remains on the proximal side of the distal end of the outer tube, and the length of the segment of the balloon body lying inwardly on the inner side of the outer tube is greater than the length of the segment of the balloon body exposed on the inner side of the sleeve.

[0018] In an optional embodiment, the material hardness of the inner tube is greater than the material hardness of the balloon body, and the material hardness of the outer tube is greater than the material hardness of the inner tube.

[0019] In an optional embodiment, a guide wire port, a charging port and an electrode cable port are provided on the handle, and the annular cavity between the inner tube and the outer tube constitutes the charging cavity of the balloon catheter, the charging cavity is communicated with the charging port, the guide wire port is communicated with the lumen of the inner tube, and the ablation electrode is connected to an electrode cable, which extends from the electrode cable port through the lumen of the inner tube.

[0020] In an optional embodiment, the ablation electrodes include two groups, the two groups of ablation electrodes are arranged on both sides of the same radial direction of the balloon body, and the spacing between the ablation electrodes relative to the axial direction of the balloon body is 10-20 mm, and each group of ablation electrodes includes an electrode seat, and the electrode seat is bonded to the outer surface of the balloon body.

[0021] In an optional embodiment, a positive electrode and a negative electrode are respectively provided on each of the electrode seats, and the electrode cables are respectively connected to the positive electrode and the negative electrode, and the spacing between the positive electrode and the negative electrode on the same electrode seat is 1-3 mm, and the positive electrode and the negative electrode are both higher than the installation top surface of the electrode seat, with a spacing of 0.2-0.5 mm.

[0022] In an optional embodiment, the electrode cable is extended from the handle and connected to the ablation device. The output frequency of the ablation device is adjustable, and the output frequency range includes 200 to 500 kHz.

[0023] In a second aspect, the present invention provides a calcified lesion treatment device, comprising a retrieval guidewire, an interception guidewire net, and a point ablation balloon catheter according to any one of the aforementioned embodiments, wherein the retrieval guidewire comprises a guide wire with a hollow structure, and the interception guidewire net can be elastically compressed in the retrieval guidewire, and can be released at the distal side of the calcified lesion site in the blood vessel after the retrieval guidewire is withdrawn;

[0024] The point ablation balloon catheter is delivered into the blood vessel through the tail end of the recovery guide wire, and can electrically stimulate the calcified lesion site through the ablation electrode, so that the calcified lesion plaque can be detached from the blood vessel wall.

[0025] In an optional embodiment, the interception guide wire net includes an interception umbrella net and a control guide wire connected to the center of the interception umbrella net, and the control guide wire is retractably and movably connected to the recovery guide wire;

[0026] The interception umbrella net comprises a nickel-titanium alloy net, and a permeable membrane is covered on the net surface;

[0027] The interception umbrella net is used to be released at the distal side of the calcified lesion site before the balloon catheter enters the blood vessel, and is used to recover the calcified lesion plaque that has fallen off and enter the retrieval guide wire by withdrawing the interception umbrella net relative to the retrieval guide wire after the balloon catheter performs ablation.

[0028] The multiple groups of ablation electrodes on the point ablation balloon catheter can be controlled in a targeted manner according to the distribution status of the calcified lesions in the blood vessels.

[0029] By rotating the rotating seat, the inner tube drives the inverted balloon body to turn outward, and at the same time, the ablation electrode on the inverted surface of the balloon body can be turned outward, so that the ablation electrode can accurately act on the calcified lesion after the balloon is subsequently pressurized.

[0030] Combined with the rotating seat, the extension length of the inner tube relative to the distal end of the sleeve can be controlled, and then a group of ablation electrodes or multiple groups of ablation electrodes can be turned outward according to the specific conditions of the lesion site, greatly improving the targeted treatment effect.

[0031] By arranging multiple groups of ablation electrodes at intervals in the axial direction of the balloon body and distributing them at different circumferential angles of the balloon body, a more flexible solution can be provided to ablate calcified lesions in different locations to meet actual application needs.

[0032] Other features and advantages of the present application will be described in detail in the subsequent detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

[0034] Figure 1 It is a schematic diagram of the overall structure of the point ablation balloon catheter;

[0035] Figure 2 It is a schematic diagram of the matching structure of the adapter, the rotating seat and the handle;

[0036] Figure 3 It is a schematic diagram of the matching structure of the balloon body, the sleeve, the outer tube and the inner tube;

[0037] Figure 4 It is a schematic diagram of the state in which the balloon body is initially extended to expose a group of ablation electrodes;

[0038] Figure 5It is a schematic diagram of the state where the balloon body is fully extended to expose two sets of ablation electrodes;

[0039] Figure 6 for Figure 5 Schematic diagram of the state of the balloon body after inflation;

[0040] Figure 7 A schematic diagram of a state where a calcified lesion treatment device performs electrical stimulation in a blood vessel;

[0041] Figure 8 It is a schematic diagram of the structure of the intercepting wire mesh.

[0042] icon:

[0043] 1-balloon body; 11-circumferential wall ring; 12-fixed port; 13-telescopic port; 14-inverted lying segment; 15-normal connection segment;

[0044] 2- casing;

[0045] 3-Outer tube;

[0046] 4-Inner tube;

[0047] 5-adapter; 51-convex ring;

[0048] 6-rotating seat; 61-annular groove;

[0049] 7-handle; 71-external thread; 72-guide wire port; 73-charging port; 74-electrode cable port;

[0050] 8-ablation electrode; 81-electrode holder; 82-positive electrode; 83-negative electrode;

[0051] 9-Retrieve the guidewire;

[0052] 10-interception wire net; 101-interception umbrella net; 102-control wire;

[0053] 20-Calcified lesion site. DETAILED DESCRIPTION

[0054] In order to make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the technical scheme in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all of the embodiments. The components of the embodiments of the present application described and shown in the drawings here can be arranged and designed in various different configurations.

[0055] In the description of this application, it should be noted that the terms "inside", "outside", etc. indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the product of the application is usually placed when in use, which is only for the convenience of describing this application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on this application. In addition, the terms "first", "second", etc. are only used to distinguish the description, and cannot be understood as indicating or implying relative importance.

[0056] In the description of this application, it should also be noted that, unless otherwise clearly specified and limited, the terms "disposed" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be the internal communication of two elements. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0057] The point ablation balloon catheter in the present application is mainly used in the treatment of calcified lesions, and is mainly used to destroy and remove calcified lesions deposited in blood vessels. By setting necessary ablation structures and improving the layout and installation of ablation structures, the treatment needs of calcified lesions 20 in different states can be met.

[0058] See also Figure 1 , and combined with Figure 2-Figure 3 The point ablation balloon catheter in the present application has a main structure including a sleeve 2 and a balloon catheter, and the balloon catheter is inserted into the sleeve 2.

[0059] The balloon catheter includes an inner tube 4, an outer tube 3 and a balloon body 1. The inner tube 4 is connected to the inside of the outer tube 3. The balloon body 1 is not a conventional proximal-distal structure, but is specifically a reverse inward-turned structure. Specifically, the distal end of the inner tube 4 is arranged on the inner side of the distal end of the outer tube 3, and one end of the balloon body 1 is connected to the distal end of the inner tube 4. The connected end can be identified as the axially retractable balloon distal end of the balloon body 1. During operation of the present invention, the connected end moves in the axial direction of the balloon catheter following the forward and backward extension of the inner tube 4, and performs substantial movement.

[0060] The other end is connected to the distal end of the outer tube 3, and the connected end can be identified as the proximal end of the balloon in a fixed state. In the present invention, the connected end does not substantially move during operation.

[0061] At least a portion of the balloon body 1 is fixedly connected to the distal end of the sleeve 2 so that the balloon body 1 can be turned inside out and lie on the inner side of the outer tube 3 in an initial state.

[0062] Specifically, the balloon body 1 is not in an unorganized and randomly active state inside the sheath 2 and the outer tube 3. By fixedly connecting one of the circumferential wall rings 11 of the balloon body 1 to the distal end of the sheath 2, it can firstly ensure its position limitation when extended and everted, and secondly, it can regulate the inflation and expansion of the balloon body 1 to a certain extent, thereby enabling the ablation electrode 8 on the outer surface of the balloon body 1 to be effectively fitted with the calcified lesion 20.

[0063] More preferably, the material hardness of the segment of the balloon body 1 at the distal end of the circumferential wall ring 11 and the outer tube 3 is the same as the material hardness of the outer tube 3, which can achieve a better expansion deformation regulation effect and promote the balloon body 1 to expand more fully. At the same time, since the circumferential wall ring 11 is connected to the distal end of the sleeve 2, it can achieve a good root positioning effect, ensuring that the balloon body 1 will not have or minimize circumferential rotational slip during expansion, thereby enabling the extended ablation electrode 8 to act more accurately on the calcified lesion sites 20 in different circumferential directions, thereby achieving precise electrical stimulation to the greatest extent.

[0064] A plurality of groups of ablation electrodes 8 are arranged on the outer surface of the balloon body 1, and when the balloon body 1 is inverted and lying on the inner side of the outer tube 3, the ablation electrodes 8 remain on the inverted surface of the balloon body 1. That is to say, in the initial state, all the ablation electrodes 8 are hidden on the outer surface of the inverted state of the balloon body 1.

[0065] Through the above technical features, part of the structure of the balloon body 1, especially part of the outer surface of the balloon body 1, can be turned inward and lie on the inner side of the outer tube 3. According to different application scenarios, the extended and everted length of the inverted and lying segment 14 of the balloon body 1 can be selectively controlled, so that the part of the balloon body 1 extending and everted can be extended to the distal end of the distal tube opening of the sleeve 2, which can ensure that the extended part after pressurization, especially the targeted controlled ablation electrode 8, is in contact with the calcified lesion 20, so as to promote electrical stimulation.

[0066] Combination Figure 4-Figure 6 , combined with multiple groups of ablation electrodes 8 arranged at intervals in the axial direction of the balloon body 1 and distributed at different circumferential angles of the balloon body 1, the number of exposed ablation electrodes 8 can be controlled by controlling the extended and everted length of the inverted and recumbent segment 14 of the balloon body 1, and the ablation electrodes 8 at different circumferential angles can be made relative to the positions of the calcified lesions 20. Further, by pressurizing the balloon body 1, the ablation electrodes 8 can be made to fit the lesions, so that subsequent electrical stimulation can promote their detachment from the blood vessel wall.

[0067] In order to control the forward and backward extension angle of the inner tube 4, a handle 7 is provided at the proximal end of the balloon catheter, and an external thread 71 is provided on the handle 7. The proximal end of the sleeve 2 is connected to an adapter seat 5 and a rotating seat 6. The proximal end of the sleeve 2 is fixedly connected to the adapter seat 5, and the rotating seat 6 can be relatively rotatably engaged with the adapter seat 5.

[0068] Specifically, the adapter seat 5 does not rotate, and the rotating seat 6 rotates relative to the adapter seat 5. In the connection between the two, the portion of the adapter seat 5 extending into the rotating seat 6 is provided with a convex ring 51, and the rotating seat 6 is provided with an annular groove 61. The convex ring 51 and the annular groove 61 are idlingly matched to realize a relatively rotatable snap-fit ​​relationship between the rotating seat 6 and the adapter seat 5.

[0069] The handle 7 is threadedly matched with the rotating seat 6, and combined with the connection relationship between the balloon catheter and the handle 7, the rotating seat 6 can make the balloon catheter move relative to the sleeve 2 and the adapter seat 5 during rotation, thereby controlling the axial extension and contraction of the inner tube 4.

[0070] When the rotating seat 6 rotates, the outer tube 3 and the sleeve 2 are in a relatively static relationship and there is no movement between the two. The proximal end of the outer tube 3 is fixedly connected to the adapter seat 5, and the inner tube 4 is connected to the handle 7, so that when the rotating seat 6 is rotated, the inner tube 4 drives the balloon body 1 to extend axially relative to the distal tube opening of the sleeve 2, and at the same time drives the inward-turned balloon body 1 to turn outward, so as to control the exposure or retraction of the ablation electrode 8.

[0071] In one specific embodiment, the balloon body 1 includes a fixed port 12 and a telescopic port 13, wherein the fixed port 12 is connected to the distal end of the outer tube 3, and the telescopic port 13 is connected to the distal end of the inner tube 4, so as to further explain and define the two different forms of the balloon body 1 in the present application and the port structure under different control conditions.

[0072] In order to improve the control range of the inner tube 4 on the inverted and recumbent segment 14 of the balloon body 1 and to facilitate the installation of multiple sets of ablation electrodes 8, in the original unreleased state, the distal end of the inner tube 4 remains on the proximal side of the distal end of the outer tube 3, and the length of the inverted and recumbent segment 14 of the balloon body 1 is greater than the length of the segment of the balloon body 1 exposed on the inner side of the sheath 2. Specifically, in order to facilitate understanding in the figure, the length of the inverted and recumbent segment 14 is greater than the normal connection segment 15.

[0073] Furthermore, the balloon body 1 is flush with the distal end of the sleeve 2 at the inverted and normally exposed folded portion, and can maintain a good initial state relationship.

[0074] In order to control the expansion and contraction of the balloon body 1 through the inner tube 4 and ensure the full expansion of the balloon body 1, the balloon body 1 is made of silicone material with relatively high elasticity, which is a compliant balloon. The balloon can be expanded by pressurizing so that the electrode can act on the lesion site.

[0075] Furthermore, the material hardness of the inner tube 4 is greater than the material hardness of the balloon body 1, and the material hardness of the outer tube 3 is greater than the material hardness of the inner tube 4, which can ensure that the balloon body 1 is pushed outward, and enable the outer tube 3 to expand and restrain the unextended part of the balloon body 1, thereby promoting the expansion deformation of the extended and everted part of the balloon body 1 to a greater extent, so that the expanded balloon body 1 drives the ablation electrode 8 on its outer surface to more reliably fit the vascular calcification lesion site 20.

[0076] From the perspective of other peripheral auxiliary functions, the handle 7 is provided with a guide wire port 72, a charging port 73 and an electrode cable port 74. The annular cavity between the inner tube 4 and the outer tube 3 constitutes the charging cavity of the balloon catheter. The charging cavity is communicated with the charging port 73, which is conducive to the expansion of the balloon body 1.

[0077] The guide wire port 72 is in communication with the lumen of the inner tube 4 , and can be guided by a guide wire to conveniently deliver the balloon catheter to the calcified lesion site 20 .

[0078] The ablation electrode 8 is connected to an electrode cable, and the electrode cable extends out from the electrode cable port 74 through the lumen of the inner tube 4 to ensure normal ablation control.

[0079] The point ablation balloon catheter in the present invention, regardless of the type of telescopic control, has the main function of electrically stimulating the calcified lesion 20 through the ablation electrode 8 to promote its detachment from the blood vessel wall.

[0080] Specifically, in one preferred embodiment, the ablation electrodes 8 include two groups, and the two groups of ablation electrodes 8 are arranged on both sides of the balloon body 1 in the same radial direction, forming a relative position relationship between the two groups of ablation electrodes 8 in the circumferential direction of the balloon body 1.

[0081] The axial spacing between the ablation electrodes 8 relative to the balloon body 1 is 10-20 mm, and the electrodes can be arranged in a staggered manner to meet the needs of electrical stimulation treatment of calcified lesions 20 at different circumferential positions in the blood vessel.

[0082] Each group of ablation electrodes 8 includes an electrode seat 81 , which is bonded to the outer surface of the balloon body 1 , thereby ensuring the fixing strength of the ablation electrodes 8 on the balloon body 1 and preventing them from falling off during the bending of the balloon body 1 .

[0083] In this embodiment, the number of extended and everted ablation electrodes 8 can be controlled by controlling the inner tube 4 to drive the everted length of the inverted accommodating segment 14 of the balloon body 1 .

[0084] Preferably, the balloon body 1 is divided into an inner surface and an outer surface in the contracted state, and the inner surface is provided with two sets of electrode seats 81, each of which has two electrodes. The two sets of electrode seats 81 are arranged on different axes, and the electrode positions at different angles can be selected according to the calcification positions on both sides of the inner wall of the blood vessel.

[0085] The two groups of electrode seats 81 are spaced 10-20 mm apart, providing a more flexible solution to ablate calcified lesions at different locations. Combined with the fixed connection ring points between the outer surface of the balloon body 1 and the sleeve 2, the position of the sleeve 2 remains unchanged through the action of the handle 7 and the rotating seat 6, so that the inner surface of the balloon extends out of the sleeve 2, and one or two groups of electrode seats 81 are exposed. Through the action of the handle 7 and the rotating seat 6, by rotating different lengths, the electrodes can be controlled to act accurately on the part that needs to be ablated, and the number of electrodes extended can also be controlled to be one or two groups.

[0086] The electrode holder 81 is provided with a positive electrode 82 and a negative electrode 83 , respectively, forming a double-electrode structure of the ablation electrode 8 . The double electrodes interact with each other to form a semicircular ablation range.

[0087] The electrode cable is connected to the positive electrode 82 and the negative electrode 83 respectively. The positive electrode 82 and the negative electrode 83 are spaced 1-3 mm apart on the same electrode holder 81. Both the positive electrode 82 and the negative electrode 83 are higher than the mounting top surface of the electrode holder 81 by a distance of 0.2-0.5 mm, so as to better fit the calcified diseased tissue.

[0088] The electrode is connected to an external ablation device through a cable connector and an electrode cable. The electrode cable is extended from the handle 7 and connected to the ablation device. By adjusting the output frequency of the ablation device, the electrical stimulation function of the calcified lesion tissue is achieved.

[0089] The output frequency of the ablation device is adjustable, and the output frequency range includes 200 to 500 kHz. The frequency can be adjusted according to the calcification situation of the lesion location to achieve electrical stimulation of the lesion location and cause the calcified tissue to fall off.

[0090] Through the point ablation balloon catheter of the present invention, the extension amount of the ablation electrode 8 can be accurately controlled, and targeted control can be performed according to the specific location of the intravascular calcified lesion site 20 to meet the actual electrical stimulation needs of the calcified lesion tissue.

[0091] In addition to promoting the shedding of calcified lesion plaques, the present invention also provides a calcified lesion treatment device, which is mainly used to remove and recover the lesion plaques after they have fallen off.

[0092] Combination Figure 7-Figure 8 The calcified lesion treatment device includes a retrieval guidewire 9, an interception guidewire net 10 and the above-mentioned point ablation balloon catheter. The retrieval guidewire 9 includes a guide wire with a hollow structure. The interception guidewire net 10 can be elastically compressed in the retrieval guidewire 9, and can be released at the distal side of the calcified lesion site 20 in the blood vessel after the retrieval guidewire 9 is withdrawn. The interception guidewire net 10 includes a nickel-titanium alloy net, and a permeable membrane is covered on the net surface.

[0093] In specific use, the intercepting guide wire mesh 10 is delivered to the distal end of the calcified lesion site 20 in a compressed state, and has at least a certain axial distance from the calcified lesion site 20 on the distal side, and then is released by the withdrawal of the hollow structure recovery guide wire 9 to block the distal end of the calcified lesion site 20, and then the subsequent point ablation balloon catheter is delivered.

[0094] It should be pointed out that the permeable membrane is provided with tiny pores through which blood can pass but calcified tissue cannot. Therefore, it is not similar to the conventional distal vascular occlusion structure, which ensures the normal circulation of blood and prevents discomfort to patients during surgery.

[0095] After releasing the intercepting guide wire mesh 10, the point ablation balloon catheter is transported into the blood vessel through the tail end of the recovery guide wire 9, especially making the distal end of the sheath 2 stay on the proximal side of the calcified lesion site 20, and by controlling the extension of the balloon body 1 and the action of the ablation electrode 8, the calcified lesion site 20 is electrically stimulated to promote the calcified lesion plaque to fall off from the blood vessel wall, and then the calcified lesion plaque is cleared and recovered.

[0096] The interception guidewire net 10 in the present invention includes an interception umbrella net 101 and a control guidewire 102 connected to the center of the interception umbrella net 101. The control guidewire 102 can be telescopically and flexibly connected to the recovery guidewire 9, and can control the withdrawal of the interception guidewire net 10. During the withdrawal process, the interception guidewire net 10 is elastically contracted in the recovery guidewire 9 through the cooperation between the center of the interception guidewire net 10 and the distal opening of the recovery guidewire 9, so that the calcified lesion plaque that has fallen off is collected back into the recovery guidewire 9.

[0097] Through the above structure and process, the recovery guide wire 9 not only plays the basic guiding function, but also further gives the hollow structure recovery guide wire 9 the function of recovering and collecting calcified lesion plaques. By completely removing the calcified lesion treatment device, it is ensured that the calcified lesion plaques are completely removed from the blood vessels after falling off.

[0098] The interception umbrella net 101 includes a nickel-titanium alloy net, and the net surface is covered with a permeable membrane, which can maintain the normal passage of blood during the recovery process of the interception umbrella net 101.

[0099] The interception umbrella net 101 is used to be released at the distal side of the calcified lesion site 20 before the balloon catheter enters the blood vessel, and is used to recover the calcified lesion plaque that has fallen off and enter the recovery guide wire 9 by withdrawing the interception umbrella net 101 relative to the recovery guide wire 9 after the balloon catheter performs ablation.

[0100] The skeleton of the interception umbrella net 101 should maintain the most obtuse angle, that is, it can ensure the collection effect of the detached calcified lesion plaque by expanding outward to the maximum extent.

[0101] The point ablation balloon catheter and the calcified lesion treatment device of the present invention can fundamentally ensure the treatment of the calcified lesion site 20 and ensure the treatment effect.

[0102] It should be noted that, in the absence of conflict, the features in the embodiments of this application may be combined with each other.

[0103] The above description is only the preferred embodiment of the present application and is not intended to limit the present application. For those skilled in the art, the present application may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A point ablation balloon catheter, characterized in that: It comprises a sleeve and a balloon catheter, wherein the balloon catheter is inserted into the sleeve; The balloon catheter comprises an inner tube, an outer tube and a balloon body, wherein the inner tube is inserted into the inner part of the outer tube, one end of the balloon body is connected to the distal end of the inner tube, and the other end is connected to the distal end of the outer tube, and at least a part of the balloon body is fixedly connected to the distal end of the sleeve, so that the balloon body can be turned inside out and lie on the inner side of the outer tube; The proximal end of the balloon catheter is provided with a handle, and the handle is provided with an external thread. The proximal end of the sleeve is connected with an adapter and a rotating seat. The proximal end of the sleeve is fixedly connected to the adapter, and the rotating seat can be relatively rotatably engaged with the adapter, and the handle is threadedly engaged with the rotating seat. The proximal end of the outer tube is fixedly connected to the adapter seat, and the inner tube is connected to the handle, so that when the rotating seat is rotated, the inner tube drives the balloon body to extend axially relative to the distal end of the sleeve, and drives the inwardly lying balloon body to turn outward at the same time; A plurality of groups of ablation electrodes are arranged on the outer surface of the balloon body, and when the balloon body is inverted and lies on the inner side of the outer tube, the ablation electrodes stay on the inverted surface of the balloon body; The multiple groups of ablation electrodes are arranged at intervals in the axial direction of the balloon body and distributed at different circumferential angles of the balloon body.

2. The point ablation balloon catheter according to claim 1, characterized in that: The balloon body comprises a fixed port and a telescopic port, wherein the fixed port is connected to the distal end of the outer tube, and the telescopic port is connected to the distal end of the inner tube.

3. The point ablation balloon catheter according to claim 1, characterized in that: In the original unreleased state, the distal end of the inner tube remains on the proximal side of the distal end of the outer tube, and the length of the segment where the balloon body lies inwardly inside the outer tube is greater than the length of the segment where the balloon body is exposed inside the sleeve.

4. The point ablation balloon catheter according to claim 1, characterized in that: The material hardness of the inner tube is greater than the material hardness of the balloon body, and the material hardness of the outer tube is greater than the material hardness of the inner tube.

5. The point ablation balloon catheter according to any one of claims 1 to 4, characterized in that: The handle is provided with a guide wire port, a charging port and an electrode cable port. The annular cavity between the inner tube and the outer tube constitutes the charging cavity of the balloon catheter. The charging cavity is communicated with the charging port. The guide wire port is communicated with the lumen of the inner tube. The ablation electrode is connected to an electrode cable, and the electrode cable extends from the electrode cable port through the lumen of the inner tube.

6. The point ablation balloon catheter according to claim 5, characterized in that: The ablation electrodes include two groups, which are arranged on both sides of the balloon body in the same radial direction, and the distance between the ablation electrodes relative to the axial direction of the balloon body is 10-20mm. Each group of ablation electrodes includes an electrode seat, which is bonded to the outer surface of the balloon body.

7. The point ablation balloon catheter according to claim 6, characterized in that: A positive electrode and a negative electrode are respectively arranged on each electrode seat, and the electrode cables are respectively connected to the positive electrode and the negative electrode, and the spacing between the positive electrode and the negative electrode on the same electrode seat is 1-3mm, and the positive electrode and the negative electrode are both higher than the installation top surface of the electrode seat, with a spacing of 0.2-0.5mm.

8. The point ablation balloon catheter according to claim 7, characterized in that: The electrode cable is extended from the handle and connected to the ablation device. The output frequency of the ablation device is adjustable, and the output frequency range includes 200-500kHz.

9. A calcified lesion treatment device, characterized in that: The invention comprises a retrieval guidewire, an interception guidewire net and a point ablation balloon catheter according to any one of claims 1 to 8, wherein the retrieval guidewire comprises a guide wire with a hollow structure, and the interception guidewire net can be elastically compressed in the retrieval guidewire and can be released at the distal side of the calcified lesion in the blood vessel after the retrieval guidewire is withdrawn; The point ablation balloon catheter is delivered into the blood vessel through the tail end of the recovery guide wire, and can electrically stimulate the calcified lesion site through the ablation electrode, so that the calcified lesion plaque can be detached from the blood vessel wall.

10. The calcified lesion treatment device according to claim 9, characterized in that: The interception guide wire net includes an interception umbrella net and a control guide wire connected to the center of the interception umbrella net, and the control guide wire is retractably and movably connected to the recovery guide wire; The interception umbrella net comprises a nickel-titanium alloy net, and a permeable membrane is covered on the net surface; The interception umbrella net is used to be released at the distal side of the calcified lesion site before the balloon catheter enters the blood vessel, and is used to recover the calcified lesion plaque that has fallen off and enter the retrieval guide wire by withdrawing the interception umbrella net relative to the retrieval guide wire after the balloon catheter performs ablation.

Images