Guide extension catheter and vascular intervention kit

Abstract

In the field of vascular intervention technology, we provide guide extension catheters and vascular intervention kits. [Solution] The guide extension catheter is a catheter 10 which includes a tubular body and a hypotube 101, a balloon 103 provided on the outer wall of the tubular body, the tubular body and the hypotube are inserted integrally, the distal end 51 of the hypotube is connected to and communicates with the balloon, and a maneuvering passage is provided in the tubular body. The radiopaque tip 20 includes an expandable tube and a radiopaque tip, the expandable tube is connected to the distal end of the catheter, and the radiopaque tip is extended or retracted along the axial direction by filling or withdrawing fluid from the chamber of the expandable tube. This solves the conventional technical problem that the catheter cannot be moved during surgery unless the balloon is deflated.

Description

Technical Field

[0001] This application relates to the field of vascular intervention technology, and particularly to a guide extension catheter and a vascular intervention kit.

Background Art

[0002] Percutaneous coronary intervention (PCI) surgery, also known as heart stent surgery, involves puncturing a blood vessel, advancing a catheter into the blood vessel, reaching the opening of the coronary artery, transporting a stent to the site where it needs to be implanted using a special delivery system, subsequently implanting it, and then removing the catheter to complete the surgery. Currently, guide extension catheters with fixed structures are commercially available. During surgery, when using such a guide extension catheter, the fixed structure can fix the guide extension catheter in the blood vessel. For example, the fixed structure can employ a balloon, which can expand to relatively fix the balloon and the blood vessel. The guide extension catheter can be stably implanted in the blood vessel during the transportation of instruments.

[0003] However, during surgery, when it is necessary to slightly advance or retract the catheter, the fixed structure has to be deflated, then the catheter is moved to the designated position, and finally the fixed structure is opened again to fix the catheter. These operation steps are cumbersome during surgery.

Summary of the Invention

Problems to be Solved by the Invention

[0004] In view of the deficiencies of the prior art, this application provides a guide extension catheter and a vascular intervention kit for solving the problem that the balloon has to be deflated to move the catheter during surgery.

Means for Solving the Problems

[0005] This application provides a guide extension catheter, the guide extension catheter comprising a tubular body and a hypotube, wherein a balloon is provided on the outer wall of the tubular body, the tubular body and the hypotube are integrally inserted, the distal end of the hypotube is connected to and communicates with the balloon, and the tubular body is further provided with an operating passage. The catheter includes a radiopaque tip portion that is extendable and retractable and connected to the distal end of the catheter.

[0006] In the guide extension catheter according to the present invention, the radiopaque tip includes a radiopaque tip and an expandable portion, one end of the expandable portion is connected to the tubular body and the other end is connected to the radiopaque tip, and the radiopaque tip extends and retracts along the axial direction of the catheter by the expandable portion.

[0007] In the guide extension catheter according to the present invention, the expandable portion includes an expandable tube, the side wall of the expandable tube has a housing chamber, one end of the expandable tube is connected to the tubular body and the other opposite end is connected to the radiopaque tip, and the housing chamber can be filled with liquid or gas, thereby driving the expandable tube to expand and move the radiopaque tip away from the catheter, and when the liquid or gas in the housing chamber is at least partially discharged, the expandable tube to contract and drive the radiopaque tip towards the catheter.

[0008] The guide extension catheter according to the present invention further includes an inner tube connected to the expansion tube and communicating with the housing chamber.

[0009] In the guide extension catheter according to the present invention, the catheter further includes a balloon fluid connection port and a tubular cavity fluid connection port, the balloon fluid connection port being connected to one end of the hypotube, the balloon fluid connection port being located at the proximal end, the tubular cavity fluid connection port being connected to and communicating with the balloon fluid connection port, and the inner tube being inserted from the tubular cavity fluid connection port into the balloon fluid connection port, connected to the expansion tube, and extending distally to communicate with the containment chamber, thereby inserting the hypotube and the balloon.

[0010] In the guide extension catheter according to the present invention, the inner tube is manufactured using a material containing a high-molecular polymer.

[0011] In the guide extension catheter according to the present invention, the stretchable tube, the catheter, and the radiopaque tip are all integrally connected and form a continuous passage.

[0012] In the guide extension catheter according to the present invention, the expandable tube is manufactured using a material that includes two layers of folded metal or polymer material.

[0013] In the guide extension catheter according to the present invention, the expandable tube is manufactured using a material containing one of three materials: PE, Pebax, or nickel-titanium alloy.

[0014] On the other hand, the present application further provides a vascular intervention kit comprising an operating instrument and a guide extension catheter, wherein the operating instrument can pass through the guide extension catheter. [Effects of the Invention]

[0015] The guide extension catheter according to this invention allows the balloon of the guide extension catheter to expand outward from the catheter after it enters the blood vessel, fixing it relative to the inner wall of the blood vessel, thereby stably placing the catheter in the blood vessel and avoiding displacement due to cardiac beating or instrument transport. The radiopaque tip connected to the distal end of the catheter can extend and retract relative to the catheter along the axial direction, and a manipulating instrument can be inserted inside the catheter, allowing the instrument to reach the target lesion area through the catheter. By equipping the catheter with an extendable radiopaque tip, the position of the distal end of the catheter relative to the lesion site can be adjusted during surgery by extending and retracting the radiopaque tip axially, eliminating the need to repeatedly constrict the fixing structure to move the catheter. This simplifies the surgical procedure and shortens the surgical time. [Brief explanation of the drawing]

[0016] In order to more clearly explain the technical solutions of the embodiments of the present application, the drawings that need to be used in describing the embodiments are briefly introduced below. Clearly, the drawings in the following description are some embodiments of the present application, and those skilled in the art can obtain further drawings based on these drawings without any creative work. [Figure 1] This is a schematic diagram of the overall structure of the guide extension catheter according to the present invention. [Figure 2] This is a schematic diagram of the structure of the guide extension catheter according to the present invention, divided into three regions: A, B, and C. [Figure 3] This is a schematic diagram of the structure of region A in Figure 2. [Figure 4] This is a schematic diagram of the structure of region B in Figure 2. [Figure 5] This is a schematic diagram of the structure of region C in Figure 2. [Figure 6] This is a schematic diagram of the cross-sectional structure of region D in Figure 4. [Figure 7] This is a schematic diagram of the cross-sectional structure of region E in Figure 4. [Figure 8] It is a schematic cross-sectional view of the region F in FIG. 5.

Embodiments for Carrying out the Invention

[0017] Hereinafter, in order to make the object, technical solution and advantages of the present application clearer, the technical solution of the present application will be clearly and completely described with reference to the drawings and specific embodiments. Obviously, the described embodiments are only some embodiments of the present application, not all embodiments. Based on the embodiments of the present application, all other embodiments obtained by those skilled in the art on the premise of not making creative labor all belong to the protection scope of the present application.

[0018] Also, the terms "first" and "second" are only used for explanation, and it cannot be understood as indicating or implying relative importance or implying the number of indicated technical features. Thus, the features limited by "first" and "second" can explicitly or implicitly include one or more of such features. In the description of the present application, the meaning of "plurality" is two or more unless specifically and clearly limited.

[0019] In the present application, the proximal end 50 refers to the end approaching the surgeon, and the distal end 51 refers to the end away from the surgeon.

[0020] Referring to FIGS. 1 to 8, the present application provides a guide extension catheter, the guide extension catheter being a catheter 10 including a tube body 102 and a hypodermic tube 101, wherein a balloon 103 is provided on the outer wall of the tube body 102, the tube body 102 and the hypodermic tube 101 are integrally inserted, the distal end 51 of the hypodermic tube 101 is connected to and communicates with the balloon 103, and an operation passage 104 is further provided in the tube body 102, and a radiopaque tip 20 that is telescopically connected to the distal end 51 of the catheter 10.

[0021] In this embodiment, the operation passage 104 of the tube body 102 is a central hole structure of the tube body 102, and surgical operation instruments such as a guide wire can be inserted into the operation passage 104. For example, the guide wire passes from the proximal end 50 of the tube body 102 into the operation passage 104, and also exits the operation passage 104 from the distal end 51 of the tube body 102. The guide wire further moves towards the distal end 51, enters the radiopaque tip 20, passes through the radiopaque tip 20, and performs surgical operations.

[0022] Referring to FIGS. 6, 7 and 8, the tube body 102 includes a three-layer structure of an outer layer 1021, an intermediate layer 1022 and an inner layer 1023. The outer layer 1021 can be manufactured from polymer materials with different hardnesses. The intermediate layer 1022 can be manufactured from metal. The inner layer is a material such as HDPE or PTFE. HDPE is a high-density polyethylene material and is suitable for reducing the transport friction of instruments as the lining of the tube body 102. PTFE is polytetrafluoroethylene and has extremely low friction coefficient, high temperature resistance and corrosion resistance characteristics.

[0023] A second layer of outtube 105 is further covered on the outer wall of the pipe body 102, and a through hole is provided in the second layer of outtube 105. The hypotube 101 is inserted into the through hole in the second layer of outtube 105. The balloon 103 is covered on the outer wall of the pipe body 102, and the balloon 103 is located outside the second layer of outtube 105. As the balloon 103 is adjacent to the second layer of outtube 105, the hypotube 101 enters by piercing into the balloon 103. The balloon 103 is located at the distal end 51 of the pipe body 102, and the second layer of outtube 105 is located at the proximal end 50 of the pipe body 102. The hypotube 101 adopts a flattened design, resulting in an elliptical cross-section. The hypotube 101 can be manufactured from materials such as nickel-titanium alloy or stainless steel. The annular gap formed between the hypotube 101 and the inner tube 30 allows fluid to be injected into the balloon 103. When the appropriate fluid is injected, the balloon 103 can inflate and be fixed within the blood vessel. When the fluid inside the balloon 103 is extracted through the hypotube 101, the balloon 103 deflates and ceases to function as a fixation device. The size of the balloon 103 is generally between 1.5 mm and 4.5 mm.

[0024] In this embodiment, after the catheter 10 of the guide extension catheter enters the blood vessel, the balloon 103 expands outward from the catheter 10 and becomes fixed relative to the inner wall of the blood vessel, allowing the catheter 10 to be stably placed in the blood vessel and avoiding displacement due to heartbeat or instrument transport. The radiopaque tip 20 connected to the distal end 51 of the catheter 10 can extend and retract relative to the catheter 10 along the axial direction of the catheter 10, and a manipulating instrument can be inserted inside the catheter 10, allowing the manipulating instrument to reach the target lesion area through the catheter 10. By equipping the catheter 10 with an extendable radiopaque tip 20, the position of the distal end 51 of the catheter 10 relative to the lesion site can be adjusted during surgery by extending and retracting the radiopaque tip 20 in the axial direction, eliminating the need to repeatedly constrict the fixing structure to move the catheter 10. This simplifies the surgical procedure and shortens the surgical time.

[0025] Referring to Figures 1 and 5, in some embodiments, the radiopaque tip 20 includes a radiopaque tip 201 and an extendable section 202, one end of which is connected to the tubular body 102 and the other end of which is connected to the radiopaque tip 201, and the radiopaque tip 201 extends and retracts along the axial direction of the catheter 10 by the extendable section 202. The extendable section 202 is connected to the catheter 10 at one end and to the radiopaque tip 201 at the other end, and the axial deformation of the extendable section 202 drives the radiopaque tip 201 to extend and retract along the axial direction relative to the catheter 10, thereby achieving positional adjustment of the distal end 51 of the catheter 10 relative to the lesion site.

[0026] The radiopaque tip 201 has a hollow conical structure and can be manufactured from a material such as metal or resin. The expandable section 202 has an internal passage, and the internal passage of the expandable section 202 communicates with the radiopaque tip 201 and the operating passage 104 of the catheter 10.

[0027] Referring to Figure 5, in some embodiments, the expandable portion 202 includes an expandable tube 203, the side wall of which has a containment chamber 204, one end of which is connected to a tubular body 102 and the other end opposite is connected to a radiopaque tip 201, and the containment chamber 204 can be filled with liquid or gas, thereby driving the expandable tube 203 to expand and move the radiopaque tip 201 away from the catheter 10, and once the liquid or gas in the containment chamber 204 has been at least partially discharged, the expandable tube 203 to contract and drive the radiopaque tip 201 towards the catheter 10.

[0028] In this embodiment, the side wall of the expansion tube 203 is a double-layered side wall, with a containment chamber 204 formed between the two layers of side walls, and the cross-section of the expansion tube 203 is annular. When liquid or gas is filled into the containment chamber 204, the expansion tube 203 stretches toward the distal end 51, driving the radiopaque tip 201 to move away from the catheter 10. When the liquid or gas is extracted from the containment chamber 204, the expansion tube 203 shrinks back to its initial state due to the action of negative pressure suction or the elastic restoring force of the expansion tube itself, moving the radiopaque tip 201 toward the proximal end 50. When the balloon 103 is fixed inside the blood vessel, the chamber 204 of the expandable tube 203 is filled with liquid or gas. After the expandable tube 203 is filled, it is deployed, and a constant force is applied to the distal end 51 of the conical radiopaque tip 201 to counteract the lesion. This can be repeated until deformation occurs in the lesion, which is useful for subsequent applications such as lesion opening and instrument transport.

[0029] Referring to Figures 1, 2, and 3, in some embodiments, the present invention preferably fills the containment chamber 204 of the expansion tube 203 with liquid, and to facilitate filling the containment chamber 204 of the expansion tube 203 with liquid, the present invention further provides a tubular body 102 cavity tube 30 connected to the expansion tube 203 and communicating with the containment chamber 204.

[0030] The catheter 10 further includes a balloon fluid connection port 40 and a tubular cavity fluid connection port 41. The balloon fluid connection port 40 is connected to one end of the hypotube 101 and is located at the proximal end 50. The tubular cavity fluid connection port 41 is connected to and communicates with the balloon fluid connection port 40. The tubular cavity tube 30 enters from the tubular cavity fluid connection port 41 to penetrate the balloon fluid connection port 40, is connected to the expansion tube 203, and extends to the distal end 51 until it communicates with the containment chamber 204, penetrating the hypotube 101 and balloon 103. A Y-type connector or multi-manifold (not shown) is provided at the proximal end 50, and the balloon fluid connection port 40 and the tubular cavity fluid connection port 41 are provided at the connector, respectively. The inner tube 30 is sealed inside the connector and passes through the opening at the proximal end of the hypo tube 101, thereby the tube cavity fluid connection port 41 communicates only with the inside of the inner tube 30, and the balloon fluid connection port 40 communicates only with the gap between the hypo tube 101 and the inner tube 30, thereby achieving physical isolation of the two fluid passages.

[0031] The balloon fluid connection port 40 can be connected to other equipment to fill or extract liquid from the balloon 103, for example, using a pressure pump or syringe. The tubular body 102 cavity tube 30 can also be connected to other equipment to fill or extract liquid from the expandable tube 203, for example, using a pressure pump or syringe.

[0032] The thickness of the tube wall formed on the two layers of sidewalls of the expansion tube 203 is the same as the thickness of the main tube 102, so there is no step at the connection point between the two, and there is also no step at the connection point between the radiopaque tip 201 and the expansion tube 203. The main tube 102 cavity tube 30 is inserted into the containment chamber 204 from the end of the expansion tube 203 that is connected to the main tube 102. A pressurizing pump can inject liquid through the main tube 102 cavity tube 30, and the liquid enters the containment chamber 204 along the main tube 102 cavity tube 30.

[0033] Referring to Figures 1 and 3, in some embodiments, the diameter of the hypotube 101 decreases from the center, and the diameter of the hypotube 101 closer to the proximal end 50 is larger than the diameter of the hypotube 101 extending from the center to the distal end 51. This configuration reduces interference between the hypotube 101 and surgical instruments during surgery.

[0034] In some embodiments, the tubular cavity tube 30 102 is manufactured using a material containing a high-molecular polymer.

[0035] The expandable tube 203 is manufactured using a double-layered folded metal or polymer material. The expandable tube 203 is manufactured using one of three materials, including PE, Pebax, and nickel-titanium alloy, and may also be manufactured using other materials. PE is a polyethylene material that is flexible and conforms to the expansion and contraction requirements of the expandable tube 203, thereby making the expandable tube 203 less susceptible to damage even with repeated expansion and contraction within blood vessels. Pebax is a polyether block amide material that possesses both rigidity and elasticity, providing stable support to resist lesions and meeting the requirements for repeated expansion and contraction.

[0036] The present application further provides a vascular intervention kit, the vascular intervention kit comprising an operating instrument and a guide extension catheter as described in any one of the embodiments of the present application, wherein the operating instrument can pass through the guide extension catheter.

[0037] The operating instrument may be a guide wire, which can be inserted into the guide extension catheter to perform the surgical procedure.

[0038] Furthermore, each functional unit in each embodiment of the present application may be integrated into a single processing unit, each unit may exist physically independently, or two or more units may be integrated into a single unit. The integrated unit can be realized in hardware form.

[0039] The above description is merely a specific embodiment of the present application, and the scope of protection of this application is not limited thereto. Any changes or substitutions within the scope of the art disclosed in this application should also be included within the scope of protection of this application. Therefore, the scope of protection of this application should be based on the scope of protection of the claims for utility model registration. [Explanation of symbols]

[0040] 10...Catheter, 101...Hypotube, 102...Tube body, 1021...Outer layer, 1022...Intermediate layer, 1023...Inner layer, 103...Balloon, 104...Operation passage, 105...Second layer of outtube, 20...Radiapetic tip, 201...Radiapetic tip, 202...Extendable part 203... Expandable tube, 204... Containment chamber, 30...Inner tube, 40...Balloon fluid connection port, 41...Tube cavity fluid connection port 50...proximal end, 51...distal end.

Claims

1. A catheter comprising a tubular body and a hypotube, wherein a balloon is provided on the outer wall of the tubular body, the hypotube extends along the axial direction of the tubular body, the distal end of the hypotube communicates with the inside of the balloon, and the tubular body is further provided with an operating passage. A radiopaque tip portion provided at the distal end of the catheter, The radiopaque tip includes a radiopaque tip and an expandable section, and the expandable section includes an expandable tube having a housing chamber in its side wall. The aforementioned expansion tube has one end connected to the pipe body and the other end connected to the radiopaque tip, and the containment chamber is in communication with the fluid passage. A guide extension catheter comprising: a radiopaque tip, wherein filling the containment chamber with fluid drives the expandable tube to move the radiopaque tip away from the catheter, and discharging the fluid from the containment chamber drives the expandable tube to move the radiopaque tip towards the catheter.

2. The guide extension catheter according to claim 1, characterized in that the radiopaque tip includes a radiopaque tip and an extendable portion, one end of the extendable portion is connected to the tubular body and the other end opposite it is connected to the radiopaque tip, and the radiopaque tip extends and retracts along the axial direction of the catheter by the extendable portion.

3. The guide extension catheter according to claim 2, wherein the expandable portion includes an expandable tube, the side wall of the expandable tube has a housing chamber, one end of the expandable tube is connected to the tubular body and the other opposite end is connected to the radiopaque tip, and the housing chamber can be filled with liquid or gas, thereby driving the expandable tube to expand and move the radiopaque tip away from the catheter, and when the liquid or gas in the housing chamber is at least partially discharged, the expandable tube to contract and drive the radiopaque tip towards the catheter.

4. The guide extension catheter according to claim 3, further comprising an inner tube connected to the expansion tube and communicating with the containment chamber.

5. The catheter further includes a proximal end connection assembly, the proximal end connection assembly being provided with a balloon fluid connection port and a tubular cavity fluid connection port. The balloon fluid connection port is in communication with the hypo tube. The inner tube is coaxially drilled inside the hypo tube, and the distal end of the inner tube passes through the hypo tube and communicates with the housing chamber of the expansion tube. The guide extension catheter according to claim 4, characterized in that an annular passage is formed between the inner wall of the hypotube and the outer wall of the inner tube, and the annular passage communicates with the balloon.

6. The guide extension catheter according to claim 4, characterized in that the inner tube is manufactured using a polymer material containing a high-molecular-weight polymer.

7. The guide extension catheter according to claim 3, characterized in that the three components—the expandable tube, the catheter, and the radiopaque tip—are all integrally connected and form a continuous passage.

8. The guide extension catheter according to claim 3, characterized in that the aforementioned expandable tube is manufactured using a material containing two layers of folded metal or polymer material.

9. The guide extension catheter according to claim 8, characterized in that the aforementioned expandable tube is manufactured using one of three materials, including PE, Pebax, and nickel-titanium alloy.

10. A vascular intervention kit comprising an operating instrument and a guide extension catheter according to any one of claims 1 to 9, wherein the operating instrument can pass through the guide extension catheter.

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