Extending catheter and balloon valve-crossing system

Abstract

The invention discloses an extension catheter and a balloon valve-crossing system, and relates to the technical field of extension catheters. The extension catheter is provided with a far end and a near end which are opposite, and the extension catheter comprises a catheter body and a rod body connected to the near end of the catheter body. In the delivery process of the extension catheter, the expandable section is in a preset state and crosses the valve with a small radial size, other interventional instruments are operated, for example, the far end of a balloon catheter is further pushed, so that the expandable section is adaptively switched to an expanded state to adapt to and allow the balloon body of the balloon catheter to cross the valve, and then the extension catheter is withdrawn to expose the balloon body, so that the balloon body is expanded. Compared with the prior art, the extension catheter and the balloon catheter are easier to cross valves, the operation difficulty is reduced, the operation efficiency is improved, and meanwhile the operation safety is improved.

Description

Technical Field

[0001] The invention belongs to the field of extended catheters, and in particular relates to an extended catheter and a balloon transvalvular system. Background Art

[0002] In interventional surgery, taking aortic valve replacement surgery as an example, when there is a certain degree of calcification in the native leaflets of the aortic valve, it is necessary to pre-expand the calcified area with a balloon before implanting the artificial valve, or to use a balloon to shape the native leaflets of the human body to facilitate the implantation of the artificial valve.

[0003] A balloon catheter usually includes a Tip at the distal end and a balloon connected to the Tip. The balloon generally has a larger radial dimension, especially at the distal end of the balloon. Due to the change in outer diameter at the connection between the Tip and different parts of the balloon body, a step is caused. When the balloon crosses the valve, it may be blocked by the calcified area and the larger angle of the aortic valve ring, resulting in failure of the balloon to cross the valve, or a longer time is required to cross the valve, affecting the progress of the operation.

[0004] In view of this, the present invention is proposed. Summary of the invention

[0005] The technical problem to be solved by the present invention is to overcome the deficiencies of the prior art and provide an extension catheter and a balloon transvalvular system.

[0006] In order to solve the above technical problems, the basic concept of the technical solution adopted by the present invention is:

[0007] An extension catheter has opposite distal and proximal ends. The extension catheter includes a catheter body and a rod body connected to the proximal end of the catheter body. The interior of the catheter body is a channel for an interventional instrument to pass through. The distal end of the catheter body has an expandable section. The expandable section has a predetermined shape and an expanded state in which the section expands radially outward after being inflated. The expandable section of the extension catheter is used to assist the interventional instrument to cross the valve.

[0008] Optionally, the expandable section is made of elastic material and has a rolled wall structure. In the expanded state, the rolled wall structure unfolds. The expandable section is rolled up by more than 360 degrees in the predetermined forming state, and the part exceeding 360 degrees overlaps with the rest of the part. The expandable section is circumferentially rolled up with a starting side and an ending side, and a flexible envelope membrane is connected between the starting side and the ending side. The flexible envelope membrane is a circumferentially closed tubular structure, and the tubular structure has a pre-folded portion.

[0009] Optionally, the proximal end of the catheter body is an equal-diameter extension section.

[0010] Optionally, the expandable section is a conical structure, and the proximal end of the expandable section is connected to the equal-diameter extension section, a skeleton structure is arranged in the equal-diameter extension section and the expandable section of the catheter body, and one or more first reinforcement layers are arranged on the outer layer of the catheter body, and the first reinforcement layer is a woven layer or a metal mesh layer.

[0011] Optionally, the expandable section includes a first section located at its distal end, and a transition section connecting the first section and the equal-diameter extension section, wherein the first section is equal-diameter extended in a predetermined state and has a smaller diameter than the equal-diameter extension section.

[0012] Optionally, the catheter body has a second reinforcement layer in the equal-diameter extension section and / or the expandable section.

[0013] Optionally, a skeleton is provided on the catheter body, and the second reinforcement layer includes the skeleton embedded in the catheter body, and the skeleton includes a plurality of annular portions spaced apart along the axial direction of the catheter body, and a connecting portion connected to each of the annular portions.

[0014] Optionally, a first developing mark is provided at the distal end of the catheter body, a second developing mark is provided at the proximal end of the catheter body, and a plurality of third developing marks are provided at different positions between the two ends of the catheter body. The first developing mark, the second developing mark and the third developing mark are all made of materials with high contrast under X-ray.

[0015] Optionally, the outer surface of the catheter body is provided with a hydrophilic coating.

[0016] A balloon transvalvular system, comprising:

[0017] An extension catheter as described in any one of the above;

[0018] A balloon catheter, wherein the distal end of the balloon catheter is provided with a balloon body, wherein the balloon body has a relatively folded state and an expanded state under the action of a fluid, wherein the balloon body movably penetrates the channel inside the catheter body in the folded state and can drive the expandable section toward an expanded state, wherein the balloon body is pre-installed in the catheter body in the folded state, and wherein the extension catheter and the balloon catheter are detachable modular structures.

[0019] After adopting the above technical solution, the present invention has the following beneficial effects compared with the prior art. Of course, any product implementing the present invention does not necessarily need to achieve all the advantages described below at the same time:

[0020] During the delivery process of the extended catheter of the present invention, the expandable section is in a pre-formed state and crosses the valve with a smaller radial size. Other interventional instruments, such as the distal end of the balloon catheter, are operated to further push the expandable section so that the expandable section adaptively switches to an expanded state to adapt to and allow the balloon body of the balloon catheter to cross the valve. The extended catheter is then withdrawn to expose the balloon body, and the balloon body is inflated to pre-expand the surrounding tissue. Compared with the prior art, the extended catheter and the balloon catheter are easier to cross the valve, which reduces the difficulty of the operation, improves the efficiency of the operation, and improves the safety of the operation.

[0021] The specific implementation modes of the present invention are further described in detail below in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The drawings described below are only some embodiments. For those skilled in the art, other drawings can be obtained based on these drawings without creative work.

[0023] In the figure:

[0024] Figure 1 A schematic diagram of a balloon transvalvular system according to an embodiment of the present invention;

[0025] Figure 2 It is a schematic diagram of the structure of the balloon transvalvular system of the present invention after the guidewire crosses the valve;

[0026] Figure 3 It is a schematic diagram of the structure of the extended catheter of the balloon transvalvular system of the present invention when it is delivered in vivo;

[0027] Figure 4 for Figure 3 Schematic diagram of the structure after the middle extension catheter crosses the valve;

[0028] Figure 5 for Figure 4 Schematic diagram of the structure of the middle balloon catheter when it is extended out of the extension catheter;

[0029] Figure 6 It is a schematic structural diagram of a balloon catheter according to an embodiment of the present invention when entering an extension catheter;

[0030] Figure 7 for Figure 6 Schematic diagram of the structure when the middle balloon catheter enters the expandable section of the extension catheter;

[0031] Figure 8 for Figure 7 A schematic diagram of the structure of the expanded section of the middle balloon catheter;

[0032] Fig. 9 It is a schematic structural diagram of a balloon catheter entering an extension catheter according to another embodiment of the present invention;

[0033] Fig.10 for Fig. 9 Schematic diagram of the structure when the middle balloon catheter enters the expandable section of the extension catheter;

[0034] Fig.11 for Fig.10 A schematic diagram of the structure of the expanded section of the middle balloon catheter;

[0035] Fig.12 It is a cross-sectional schematic diagram of the expandable section of the extension catheter of the present invention in a pre-formed state;

[0036] Fig.13 for Fig.12 A schematic cross-sectional view of the expandable section being expanded and unfolded;

[0037] Fig.14 It is a cross-sectional schematic diagram of the invention in which the expandable section can change the winding angle;

[0038] Fig.15 It is a cross-sectional schematic diagram of a flexible envelope membrane provided in the expandable section of the present invention;

[0039] Fig.16 It is a cross-sectional schematic diagram of the flexible envelope membrane of the present invention being in an overall tubular shape;

[0040] Fig.17 for Fig.16 Schematic diagram of the cross section of the expandable section of the rolled wall structure under expansion and unfolding.

[0041] Fig.18 It is a schematic structural diagram of the proximal end of the tubular structure of the extension catheter of the present invention;

[0042] Fig.19 A partial structural view of a skeleton according to an embodiment of the present invention;

[0043] Fig. 20 A partial structural view of a skeleton according to another embodiment of the present invention;

[0044] Fig.21a It is a schematic cross-sectional view of a ring-shaped portion of a constant diameter extension section according to an embodiment of the present invention;

[0045] Figure 21b It is a schematic cross-sectional view of an expandable section of an extension catheter in a predetermined state at one of its annular portions according to an embodiment of the present invention;

[0046] Figure 22-Figure 24 It is a cross-sectional schematic diagram of the rod body and the catheter body of the extension catheter of the present invention;

[0047] Fig.25 It is a schematic structural diagram of the balloon body of the balloon catheter of the present invention in a folded state;

[0048] Fig.26It is a schematic structural diagram of the balloon body of the balloon catheter of the present invention in an expanded state;

[0049] In the accompanying drawings, the components represented by the reference numerals are listed as follows:

[0050] 101, proximal end; 102, distal end;

[0051] 200, extension catheter; 210, rod body; 220, expandable section; 221, tube wall; 222, starting side; 223, end side; 224, overhanging part; 225, non-overhanging part; 226, overlapping area; 227, first section; 228, transition section;

[0052] 230, flexible envelope; 231, pre-folding portion; 232, first turning point; 233, second turning point;

[0053] 240, catheter body; 241, equal diameter extension section; 243, annular portion; 244, connecting portion; 245, notch;

[0054] 251, first development mark; 252, second development mark;

[0055] 300, balloon catheter; 310, balloon body; 320, inner tube; 330, outer tube; 331, fluid channel;

[0056] 400, guide wire; 500, handle; 600, valve orifice.

[0057] It should be noted that these drawings and textual descriptions are not intended to limit the conceptual scope of the present invention in any way, but are intended to illustrate the concept of the present invention for those skilled in the art by referring to specific embodiments. DETAILED DESCRIPTION

[0058] The present invention will now be described in further detail with reference to the accompanying drawings.

[0059] See also Figure 1-26As shown, in this embodiment, an extension catheter is provided, which has a relative distal end 102 and a proximal end 101. The extension catheter includes a catheter body 240 and a rod body 210 connected to the proximal end of the catheter body 240. The handle part of the rod body 210 is provided with an anti-slip texture or an ergonomic design to improve stability and comfort during operation; a bending adjustment mechanism, such as a shape memory alloy wire or a bending adjustment knob, is integrated on the rod body 210, and a safety locking mechanism is provided on the rod body 210 to prevent the extension catheter 200 or the balloon catheter 300 from moving suddenly due to accidental operation during the operation, so that the curvature of the extension catheter 200 can be adjusted as needed during the operation to improve the success rate of transvalvular surgery. The interior of the catheter body 240 is a channel for the interventional instrument to pass through. The distal end of the catheter body 240 is provided with an expandable section 220, and the expandable section 220 has a predetermined shape state and an expanded state of radial outward expansion after being inflated. The expandable section 220 of the extension catheter 200 is used to assist the interventional instrument in transvalvular surgery.

[0060] The expandable section 220 of this embodiment is made of elastic material and has a rolled wall structure. In the expanded state, the rolled wall structure unfolds. The expandable section 220 is rolled up in a predetermined state with an amplitude greater than 360 degrees, and the portion exceeding 360 degrees overlaps with the remaining portions. The expandable section 220 is circumferentially rolled with a starting side 222 and a tail side 223. A flexible envelope membrane 230 is connected between the starting side 222 and the tail side 223. The flexible envelope membrane 230 is a circumferentially closed tubular structure with a pre-folded portion 231. The proximal end of the catheter body 240 is an equal-diameter extension section 241. The shape of the expandable section 220 adopts any one of the following two embodiments.

[0061] In Example 1, the expandable section 220 is a conical structure, and the proximal end of the expandable section 220 is connected to the equal-diameter extension section 241. A skeleton structure is arranged in the equal-diameter extension section 241 of the catheter body 240 and the expandable section 220 to improve the overall compression and torsion resistance of the catheter body 240; one or more first reinforcement layers are arranged on the outer layer of the catheter body 240, and the first reinforcement layer is a woven layer or a metal mesh layer to enhance its radial support force and anti-puncture ability.

[0062] In the second embodiment, the expandable section 220 includes a first section 227 at its distal end, and a transition section 228 connecting the first section 227 and the equal-diameter extension section 241 . The first section 227 is equal-diameter extended in a predetermined state and has a smaller diameter than the equal-diameter extension section 241 .

[0063] The catheter body 240 of this embodiment has a second reinforcement layer in the equal-diameter extension section 241 and / or the expandable section 220. A skeleton is provided on the catheter body 240. The second reinforcement layer includes a skeleton embedded in the catheter body 240. The skeleton includes a plurality of annular portions 243 arranged at intervals along the axial direction of the catheter body 240, and a connecting portion 244 connected to each annular portion 243.

[0064] In this embodiment, a first developing mark 245 is provided at the distal end of the catheter body 240, a second developing mark 245 is provided at the proximal end of the catheter body 240, and a plurality of third developing marks are provided at different positions between the two ends of the catheter body 240 so as to more accurately track the position and shape of the catheter body 240 in the body. The first developing mark 245, the second developing mark 245, and the third developing mark are all made of materials with high contrast under X-rays to improve their visibility in the body, and the outer surface of the catheter body 240 is provided with a hydrophilic coating.

[0065] See also Figure 1-26 As shown, the present application provides a balloon transvalvular system including an extension catheter 200, the extension catheter 200 having a distal end 102 and a proximal end 101 opposite to each other. The extension catheter 200 includes a catheter body 240 and a rod body 210, and the distal end of the rod body 210 is connected to the proximal end of the catheter body 240. The interior of the catheter body 240 is a channel for other interventional instruments to pass through. The distal end of the catheter body 240 has an expandable section 220, and the expandable section 220 has a predetermined shape state and an expanded state of radial expansion after being inflated. The delivery distance of the extension catheter 200 at least allows the expandable section 220 to cross the valve, for example, to cross the aortic valve orifice 600 as shown in the figure.

[0066] The expanded state of the expandable section 220 has a larger radial dimension than the pre-formed state, which is conducive to the balloon catheter 300 passing through and extending the expandable section 220. The corresponding pre-formed state of the expandable section 220 can be delivered in vivo with a smaller radial dimension and perform cross-valve operations. One of the key points of this application is the optimization and improvement of the extension catheter 200, that is, it is understood to provide an extension catheter. For the convenience of explanation and understanding, the changes of the extension catheter 200 during use are specifically described in combination with corresponding interventional instruments such as the balloon catheter 300 and the guidewire 400.

[0067] The balloon transvalvular system also includes a balloon catheter 300, the distal end of which is a balloon body 310, which has a relatively collapsed state and an expanded state under the action of a fluid, such as saline. The balloon body 310 moves through the channel of the catheter body 240 in the collapsed state, and drives the expandable section 220 toward the expanded state when passing through the expandable section 220. The balloon body 310 expands after extending the extension catheter 200 to pre-expand the surrounding tissue, such as the calcified part of the native valve leaflet, to facilitate the subsequent placement of the stent.

[0068] The transvalvular operation of the balloon transvalvular system of this embodiment specifically includes:

[0069] S100: Figure 2 As shown, a guidewire 400 is delivered into the body and across the valve.

[0070] S200: Figure 3As shown, the push rod 210 is used to deliver the extension catheter 200 toward the distal end along the guide wire 400. During the delivery process, the guide wire 400 is used to guide or bend the catheter 200 with assistance of a bend adjusting member until the distal end of the extension catheter 200 reaches the vicinity of the aortic valve orifice 600.

[0071] S300: After the distal end of the extension catheter 200 is aligned with the valve orifice 600, Figure 4 As shown, the extension catheter 200 is further pushed to the distal end to pass the expandable section 220 through the valve orifice 600 in a predetermined state. Since the expandable section 220 has a smaller conical radial dimension and fits tightly with the guide wire, the transvalvular operation is easier than the prior art, which can reduce the difficulty of operation, improve the efficiency of the operation, and improve safety.

[0072] S400: Figure 5 As shown, the balloon catheter 300 is delivered. When the balloon catheter 300 enters the expandable section 220, the expandable section 220 adaptively switches to an expanded state to adapt to the radial size of the balloon catheter 300. During this process, the balloon catheter 300 also completes the transvalvular operation.

[0073] S500: After the balloon catheter 300 has successfully crossed the valve, the operating rod body 210 is retracted to extend the catheter 200 to expose the balloon body 310, and then the balloon body 310 is inflated by injecting liquid to pre-expand the surrounding tissue.

[0074] The balloon transvalvular system of the present application extends the expandable section 220 of the catheter 200 in a predetermined state, i.e., a smaller radial size, for in vivo delivery and transvalvular operation. When the balloon catheter 300 passes through the expandable section 220, the expandable section 220 adaptively switches to an expanded state until the transvalvular operation of the balloon catheter 300 is completed. Therefore, the balloon transvalvular system of the present application can more easily complete the transvalvular operation and the in vivo delivery operation than the prior art, while improving the safety and efficiency of the operation.

[0075] See also Fig.18 The distal end of the catheter body 240 is provided with a first developing mark 251, and the proximal end of the catheter body 240 is provided with a second developing mark 252, and the position of the catheter body 240 in the body can be observed with the aid of a developing device. The developing mark includes but is not limited to a ring structure, and the setting method includes but is not limited to being embedded in the catheter body 240. The first developing mark 251 is set at the end of the distal end of the expandable section 220, or is set adjacent to the end of the distal end of the expandable section 220, wherein the first developing mark 251 does not limit the expansion and resetting movement of the expandable section 220.

[0076] The catheter body 240 includes an equal diameter extension section 241 connected to the proximal end of the expandable section 220. The expandable section 220 has one of the following shapes:

[0077] a. Figure 6As shown, the expandable section 220 is a tapered shape that gradually converges from the proximal end of the expandable section 220 to the distal end of the expandable section 220 and presents a streamlined structure, and the generatrix of the tapered shape is an arc or a curve;

[0078] b. Fig. 9 As shown, the expandable section 220 includes a first section 227 located at its distal end, and a transition section 228 connecting the first section 227 and the equal-diameter extension section 241, wherein the first section 227 is an equal-diameter extension with a diameter smaller than that of the equal-diameter extension section 241, and the transition section 228 is conical.

[0079] The expandable section 220 is made of elastic material and the tube wall 221 is a rolled wall structure with a coiled cross section. Figure 6-Figure 8 or Figure 9-11 The balloon catheter 300 passes from right to left, and squeezes the inner side of the expandable section 220 where it passes, so that the rolling wall structure unfolds accordingly, and the expandable section 220 switches from the predetermined state to the expanded state.

[0080] When the balloon catheter 300 passes through the corresponding part of the expandable section 220, the rolled wall structure of the corresponding part tends to recover to the predetermined state by virtue of its own elasticity.

[0081] In this embodiment, the wall material of the expandable section 220 is selected from HDPE or Pebax, and the thickness of the wall is 0.5 mm, for example. The outer periphery of the catheter body 240 is provided with a hydrophilic coating to improve the smoothness of delivery in the body.

[0082] See also Fig.12 , the figure shows a cross-sectional schematic diagram of the expandable section 220 in a predetermined shape. To form a complete channel, the tube wall 221 in the predetermined shape is wound more than 360 degrees, that is, it extends more than 360 degrees in the circumferential direction from the starting side 222 to the end side 223 of the winding, and the part exceeding 360 degrees overlaps and connects with the remaining part, that is, the part not exceeding 225 in the figure. Among them, the exceeding part 224 is wrapped around the outer periphery of the part not exceeding 225.

[0083] See also Fig.13 The figure shows a cross-sectional schematic diagram of the expandable section 220 when the balloon catheter 300 passes through the expandable section 220. When the expandable section 220 is in the expanded state, the winding amplitude of the rolled wall structure is greater than 360 degrees, that is, there is still an overlapping overlap area 226, which prevents the balloon catheter 300 from being exposed when the expandable section 220 is in the expanded state.

[0084] For further preference, see Fig.14 The overlapping area 226 is enlarged, and the degree of winding of the tube wall 221, that is, the corresponding central angle, is further increased to 540 degrees. After unfolding, it will obtain a larger inner diameter, allowing interventional devices with larger radial dimensions to pass through.

[0085] See again Fig.12 Although the protruding portion 224 and the non-protruding portion 225 overlap each other, they are not relatively fixed. They can slide relative to each other and there is a gap between them. Blood or body fluids may enter and exit the tube wall through the gap, so that a closed channel can be formed under different conditions.

[0086] In one embodiment, see Fig.15 The starting side 222 and the ending side 223 of the tube wall 221 are connected by a flexible envelope 230 . The flexible envelope 230 can limit the maximum expansion degree of the tube wall 221 and always maintain the circumferential continuity of the tube wall 221 .

[0087] In another embodiment, Fig.16 In the figure, the flexible envelope film 230 is a circumferentially closed tubular structure, and the flexible envelope film 230 has a pre-folded portion 231. In the figure, the tube wall 221 is fixedly attached to the outer wall of the flexible envelope film 230, and the pre-folded portion 231 is located between the starting side 222 and the ending side 223 of the tube wall 221. The first turning point 232 and the second turning point 233 of the pre-folded portion 231 are provided with crease lines, which can be processed by heat setting treatment. In the pre-setting state, the crease lines can make the turning point of the pre-folded portion 231 smoother. Fig.17 When the expandable section 220 is expanded, the pre-folded portion 231 unfolds, allowing the expandable section 220 to expand to a larger radial size.

[0088] The thickness and rigidity of the flexible envelope 230 are lower than those of the tube wall 221. For example, the flexible envelope 230 is made of PTFE material with a wall thickness of 0.25-0.5 mm. The flexible envelope 230 and the tube wall 221 can be fixed to the tube wall by welding or other methods.

[0089] In one embodiment, the catheter body 240 has a second reinforcement layer in the equal diameter extension section 241 to prevent the tube wall from being stressed and wrinkled when the balloon catheter is delivered. The reinforcement layer is a skeleton embedded in the catheter body 240, which can be a braided layer or can be cut from a tube, such as a hypotube. Fig.19 - Fig.21a As shown, the shape of the skeleton includes a plurality of annular portions 243 spaced from the proximal end to the distal end, and a connecting portion 244 connecting the annular portions 243. The annular portions 243 may be as follows: Fig.19 The closed ring or Fig. 20 As shown, there is a notch 245 , and the connecting portion 244 is rod-shaped or strip-shaped. The number of the connecting portion 244 is one or more. When there are multiple connecting portions 244 , they are arranged at intervals in the circumferential direction around the annular portion 243 .

[0090] In one embodiment, the connecting portion 244 can extend out of the catheter body 240 along the axial direction to serve as the rod body 210 of the extension catheter 200 .

[0091] Combination Fig.21a , shows a cross-sectional view of the equal diameter extension section 241 at one of the annular portions 243, in which the annular portion 243 has a notch 245. For easy distinction, Fig.21a In the figure, the notch 245 is indicated by a bold dotted line, and the annular portion 243 is indicated by a bold solid line. The two ends of the annular portion 243 are further extended and butted to form a closed annular shape.

[0092] In another embodiment, the expandable section 220 also has a second reinforcement layer. Figure 21b The skeleton includes a plurality of annular portions 246 (bold solid lines in the figure) arranged at intervals from the proximal end to the distal end, and a connecting portion connecting the annular portions 246, wherein the annular portion 246 has an A end and a B end, and has a notch, which is adapted to the overlapping overlap region 226, the A end is arranged close to the starting side 222 and is radially close to the trailing side 223, and the B end is arranged close to the trailing side 223 and is radially close to the starting side 222, that is, the degree of the central angle of the notch is substantially the same as the degree of the central angle of the overlapping overlap region 226, and the shape of the annular portion 246 is substantially the same as the aforementioned annular portion 243, and the shape of the connecting portion refers to the aforementioned embodiment;

[0093] Among them, end A can also extend to the starting side 222, and end B can also extend to the ending side 223, that is, the annular parts partially overlap in the radial direction; in other embodiments, end A can also be at A', and end B can also be at B', that is, the center angle of the notch is greater than the center angle of the overlapping overlap area 226.

[0094] The rod body 210 may be a single rod, and the material may be stainless steel, etc. The arrangement between the rod body 210 and the catheter body 240 is one of the following:

[0095] like Fig. 22 , the rod body 210 is connected to the inner wall of the catheter body 240;

[0096] like Fig.23 , the rod body 210 is connected to the inside of the catheter body 240;

[0097] like Fig.24 The rod body 210 is connected to the outer wall of the catheter body 240 .

[0098] In one embodiment, the distal end of the rod body 210 is cut to form a plurality of cut wire strips, which are braided and connected to the equal-diameter extension section at the proximal end of the catheter body.

[0099] In one embodiment, the balloon body 310 can be pre-installed in the catheter body 240 in a folded state, for example, pre-installed in the equal-diameter extension section 241 , and during the delivery process, the balloon body 310 is delivered together with the equal-diameter extension section 241 .

[0100] See also Fig.25 and Fig.26 In one embodiment, the balloon catheter 300 also includes an inner tube 320 and an outer tube 330. The interior of the inner tube 320 is a guidewire channel. The balloon body 310 is located on the outer periphery of the inner tube 320. The outer tube 330 is connected to the proximal side of the balloon body 310. The radial gap between the inner tube 320 and the outer tube 330 serves as a fluid channel 331 connected to the interior of the balloon body 310. When expanded, the fluid flows through the fluid channel 331 until it flows into the balloon body 310 to expand it.

[0101] In one embodiment, the balloon transvalvular system further includes a handle 500 , and the proximal ends of the extension catheter 200 and the balloon catheter 300 are both connected to and controlled by the handle 500 , which facilitates operation. The extension catheter 200 is connected to and controlled by the handle 500 via the rod 210 .

[0102] The balloon transvalvular system of the present application extends the expandable section 220 of the catheter 200 to a predetermined shape, i.e., a smaller radial dimension, for transvalvular operation. When the balloon catheter 300 passes through the expandable section 220, the expandable section 220 adaptively switches to an expanded state until the transvalvular operation of the balloon catheter 300 is completed. Therefore, the balloon transvalvular system of the present application can complete the transvalvular operation more easily than the prior art, while improving the safety and efficiency of the operation.

[0103] The contents not described in detail in this specification belong to the prior art known to professional and technical personnel in the field. All electrical appliances in the present invention are powered by external power supplies or built-in batteries. All electrical appliances in the present invention are not limited to models and specific types. Those skilled in the art can clearly use applicable electrical appliance models and specific types and electrical power supply methods based on common sense in the field.

[0104] The present invention is not limited to the above-mentioned embodiments. Anyone should be aware that any structural changes made under the enlightenment of the present invention, and any technical solutions that are the same or similar to the present invention, fall within the protection scope of the present invention. The technology, shape, and structural parts not described in detail in the present invention are all well-known technologies.

Claims

1. An extension catheter having a distal end (102) and a proximal end (101) opposite to each other, characterized in that: The invention comprises a catheter body (240) and a rod body (210) connected to the proximal end of the catheter body (240); the interior of the catheter body (240) is a channel for the interventional instrument to pass through; the distal end of the catheter body (240) is provided with an expandable section (220); the expandable section (220) has a predetermined shape state and an expanded state of radial outward expansion after being inflated; the expandable section (220) of the extension catheter (200) is used to assist the interventional instrument to cross the valve.

2. An extension catheter according to claim 1, characterized in that: The expandable section (220) is made of elastic material and has a rolled wall structure. In the expanded state, the rolled wall structure unfolds. The expandable section (220) is rolled up to a width greater than 360 degrees in the predetermined state, and the portion exceeding 360 degrees overlaps with the remaining portion. The expandable section (220) is rolled up in the circumferential direction to have a starting side (222) and an ending side (223). A flexible envelope membrane (230) is connected between the starting side (222) and the ending side (223). The flexible envelope membrane (230) is a circumferentially closed tubular structure, and the tubular structure has a pre-folded portion (231).

3. An extension catheter according to claim 1, characterized in that: The proximal end of the catheter body (240) is an equal-diameter extension section (241).

4. An extension catheter according to claim 3, characterized in that: The expandable section (220) is a conical structure, and the proximal end of the expandable section (220) is connected to the equal-diameter extension section (241), a skeleton structure is arranged in the equal-diameter extension section (241) of the catheter body (240) and the expandable section (220), and one or more first reinforcement layers are arranged on the outer layer of the catheter body (240), and the first reinforcement layer is a woven layer or a metal mesh layer.

5. The extension catheter according to claim 3, characterized in that: The expandable section (220) includes a first section (227) located at its distal end, and a transition section (228) connecting the first section (227) and the equal-diameter extension section (241), wherein the first section (227) is equal-diameter extended in a predetermined state and has a smaller diameter than the equal-diameter extension section (241).

6. The extension catheter according to claim 3, characterized in that: The catheter body (240) has a second reinforcement layer in the equal-diameter extension section (241) and / or the expandable section (220).

7. An extension catheter according to claim 6, characterized in that: The catheter body (240) is provided with a skeleton, and the second reinforcement layer is included in the skeleton embedded in the catheter body (240), and the skeleton includes a plurality of annular portions (243) arranged at intervals along the axial direction of the catheter body (240), and a connecting portion (244) connected to each of the annular portions (243).

8. The extension catheter according to claim 1, characterized in that: A first developing mark (245) is arranged at the distal end of the catheter body (240), a second developing mark (245) is arranged at the proximal end of the catheter body (240), and a plurality of third developing marks are arranged at different positions between the two ends of the catheter body (240), and the first developing mark (245), the second developing mark (245), and the third developing marks are all made of materials with high contrast under X-ray.

9. The extension catheter according to claim 1, characterized in that: The outer surface of the catheter body (240) is provided with a hydrophilic coating.

10. A balloon transvalvular system, characterized in that: include: The extension catheter according to any one of claims 1 to 9; A balloon catheter (300), wherein the distal end of the balloon catheter (300) is provided with a balloon body (310), wherein the balloon body (310) has a relatively collapsed state and an expanded state under the action of a fluid, wherein the balloon body (310) can movably penetrate the channel inside the catheter body (240) in the collapsed state, and can drive the expandable section (220) toward an expanded state, wherein the balloon body (310) is pre-installed in the catheter body (240) in the collapsed state, and the extension catheter (200) and the balloon catheter (300) are detachable modular structures.

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