Catheter with end capable of changing states and using method

Abstract

The invention discloses a catheter with a state-changeable end and a using method, and relates to the technical field of interventional medical instruments. And a deformable body and an adjusting assembly. The diameter of the deformable body is adjusted through the adjusting assembly, so that the diameter of at least part of the deformable body is gradually reduced from the near-end direction to the far-end direction, in the advancing process of the catheter, the deformable body is kept to be small in size, blood vessel wall damage caused by the windowsill effect is prevented, and operation of an operator is convenient and fast; the intervention difficulty is reduced; after the deformable body is in place, the diameter of at least part of the deformable body can be gradually increased from the near-end direction to the far-end direction through the adjusting assembly, the larger suction area is obtained in the suction process due to the increase of the size of the deformable body, the suction efficiency and the thrombus removing effect are improved, the operation time is shortened, and the operation risk is reduced.

Description

Technical Field

[0001] The present application relates to the technical field of interventional medical devices, and in particular to a catheter with a changeable end and a method of using the catheter. Background Art

[0002] The size structure of the interventional medical catheters currently on the market is fixed during the design and production process, and the size change of the catheter tip cannot be adjusted. During the advancement and pushing of the catheter, when encountering a vascular fork, the catheter with a larger tip is prone to a windowsill effect (the tip presses against the intersection and cannot be pushed along the target vascular path). In addition, after reaching the location of the thrombus, when encountering a large thrombus, it is impossible to wrap the thrombus or expand the suction surface to improve the thrombus removal efficiency, which will greatly affect the doctor's surgical efficiency and thrombus removal efficiency. Summary of the invention

[0003] The present application aims to solve one of the above-mentioned technical problems in the prior art. To this end, an embodiment of the present application provides a catheter with a changeable end state.

[0004] The embodiment of the present application also provides a method for using a catheter.

[0005] According to an embodiment of the first aspect of the present application, a catheter with a transformable end state is provided, comprising a catheter body; a deformable body, arranged at the distal end of the catheter body; and an adjustment component, for adjusting the diameter of the deformable body so that the diameter of at least a portion of the deformable body gradually decreases from the proximal direction to the distal direction, or the diameter of at least a portion of the deformable body gradually increases from the proximal direction to the distal direction.

[0006] The above-mentioned catheter with a transformable end has at least the following beneficial effects: the diameter of the deformable body is adjusted by adjusting the component, so that the diameter of at least part of the deformable body gradually decreases from the proximal direction to the distal direction. During the movement of the catheter, the deformable body maintains a smaller size, which is convenient for passing through the bifurcation of the blood vessel, preventing damage to the blood vessel wall due to the windowsill effect, and also convenient for the operator to operate and reduce the difficulty of intervention; after being in place, the diameter of at least part of the deformable body can be gradually enlarged from the proximal direction to the distal direction through the adjusting component. The increase in the size of the deformable body obtains a larger suction area during the suction process, improves the suction efficiency and thrombus removal effect, reduces the operation time, and reduces the surgical risk.

[0007] According to the catheter with a transformable end state described in the first aspect of the present application, the diameter of the deformation body is the same as the diameter of the catheter body and is connected end to end, and part of the adjustment component is hidden inside the deformation body.

[0008] According to the catheter with a transformable end state described in the embodiment of the first aspect of the present application, the adjustment component includes an adjustment member and an electric heating element, a plurality of the adjustment members are arranged in a circular array with the central axis of the deformable body as the center, the adjustment members are arranged along the axial direction of the deformable body, and the distal end of the adjustment member is inclined toward the central axis of the deformable body, and the electric heating element is used to drive the distal end of the adjustment member to change from being inclined toward the central axis of the deformable body to being inclined toward the direction away from the central axis of the deformable body.

[0009] According to the catheter with a changeable end state described in the embodiment of the first aspect of the present application, the adjusting member is made of a memory alloy, and the electric heating element is used to heat the adjusting member to cause the inclined portion of the adjusting member to rotate.

[0010] According to the catheter with a changeable end state described in the embodiment of the first aspect of the present application, the steering angle of the adjusting member is set to 160° to 180°.

[0011] According to the catheter with a transformable end state described in the embodiment of the first aspect of the present application, the adjusting member is a deformable spring, and the deformable spring includes a first section and a second section. One end of the first section and one end of the second section are connected and extend to a distal end close to the deformable body, and the other end of the first section or the other end of the second section is connected to a pulling power input source provided inside and / or outside the catheter body.

[0012] According to the catheter with a changeable end state described in the embodiment of the first aspect of the present application, the second section has a straight portion, and part of the first section is arranged around the outside of the straight portion.

[0013] According to the catheter with a transformable end described in the embodiment of the first aspect of the present application, the deformation body is provided with a channel for placing the adjusting member, and there is a gap between the channel and the adjusting member.

[0014] According to the catheter with a changeable end state described in the embodiment of the first aspect of the present application, a developing component is provided at the distal edge of the deformable body, and the material of the developing component is one or more of gold, platinum, tantalum, and iridium.

[0015] According to an embodiment of the second aspect of the present application, a method for using the catheter with a changeable end is provided, comprising the following steps:

[0016] The deformation body is maintained in a contracted state under the action of the adjustment component, so that the diameter of at least a portion of the deformation body gradually decreases from the proximal direction to the distal direction;

[0017] The catheter body with the deformable body is introduced through the radial artery or the femoral artery, and the deformable body in the contracted state guides the catheter body through the bifurcation of the blood vessel to approach the lesion position of the target blood vessel;

[0018] Using the adjustment component, the deformable body is changed from a contracted state to an expanded state, wherein the diameter of at least a portion of the deformable body in the expanded state gradually increases from the proximal direction to the distal direction, so that the distal edge of the deformable body is close to the blood vessel wall;

[0019] The external device providing suction force starts the suction operation, and the thrombus enters the catheter body under the guidance of the deformable body, and then is drawn out of the blood vessel through the catheter body;

[0020] The external device providing suction force stops the suction work, and then the adjustment component is used to adjust the deformable body from the expanded state to the contracted state;

[0021] The catheter body having the deformed body is removed from the human body.

[0022] Additional aspects and advantages of the present application will be given in part in the description below, and in part will become apparent from the description below, or will be learned through the practice of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The present application is further described below with reference to the accompanying drawings and embodiments;

[0024] Figure 1 is a schematic diagram of the connection between the deformation body and the catheter body in an embodiment of the present application;

[0025] Figure 2 This is a schematic diagram of the structure of the deformable body in the expanded state in the embodiment of the present application. Figure 1 ;

[0026] Figure 3 This is a schematic diagram of the structure of the deformable body in the contracted state in the embodiment of the present application. Figure 1 ;

[0027] Figure 4 This is a schematic diagram of the structure of the deformable body in the contracted state in the embodiment of the present application. Figure 2 ;

[0028] Figure 5 This is a schematic diagram of the structure of the deformable body in the expanded state in the embodiment of the present application. Figure 2 ;

[0029] Figure 6 is a schematic diagram of unfolding a deformable body in an embodiment of the present application;

[0030] Figure 7 is a schematic diagram of deformation of a memory alloy in an embodiment of the present application;

[0031] Figure 8 is a schematic structural diagram of a deformable spring in an embodiment of the present application;

[0032] Fig. 9 It is a deformation diagram of a deformation spring in an embodiment of the present application.

[0033] Figure numerals: catheter body 100 , deformation body 200 , deformation channel 210 , adjustment component 300 , memory alloy 310 , microcatheter 321 , first section 322 , spiral winding portion 3221 , second section 323 . DETAILED DESCRIPTION

[0034] This section will describe in detail the specific embodiments of the present application. The preferred embodiments of the present application are shown in the accompanying drawings. The purpose of the accompanying drawings is to supplement the description of the text part of the specification with graphics, so that people can intuitively and vividly understand each technical feature and the overall technical solution of the present application, but it cannot be understood as a limitation on the scope of protection of the present application.

[0035] In the description of the present application, it should be understood that descriptions involving orientation, such as up, down, front, back, left, right, etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present application and simplifying the description, and do 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 should not be understood as a limitation on the present application.

[0036] In the description of this application, "several" means one or more, "more" means more than two, "greater than", "less than", "exceed", etc. are understood to exclude the number itself, and "above", "below", "within", etc. are understood to include the number itself. If there is a description of "first" or "second", it is only used for the purpose of distinguishing technical features, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features or implicitly indicating the order of the indicated technical features.

[0037] In the description of this application, unless otherwise clearly defined, terms such as setting, installing, connecting, etc. should be understood in a broad sense, and technicians in the relevant technical field can reasonably determine the specific meanings of the above terms in this application based on the specific content of the technical solution.

[0038] In order to describe the present invention more clearly, the meanings of the two concepts of "distal end" and "proximal end" are defined here. The above concepts are commonly used terms in the field of interventional medical devices. Specifically, the "distal end" refers to the end away from the operator during the operation, and the "proximal end" refers to the end close to the operator during the operation. Of course, for a single device object, the "proximal end" can also be described as the end close to the operator, and the "distal end" can also be described as the end away from the operator.

[0039] Reference Figures 1 to 5 An embodiment of the present application provides a catheter with a changeable end state, the catheter comprising a catheter body 100, a deformation body 200 and an adjustment component 300.

[0040] Among them, the deformable body 200 is arranged at the distal end of the catheter body 100, and the adjustment component 300 is used to adjust the diameter of the deformable body 200 so that the diameter of at least a part of the deformable body 200 gradually decreases from the proximal direction to the distal direction (that is, the distal end of the deformable body 200 is in a contracted state), or the diameter of at least a part of the deformable body 200 gradually increases from the proximal direction to the distal direction (that is, the distal end of the deformable body 200 is in an expanded state).

[0041] In other words, the adjustment component 300 can maintain the deformable body 200 in a contracted state or an expanded state, and can also transform the deformable body 200 from a contracted state to an expanded state, and vice versa.

[0042] It should be noted that the deformed portion of the deformable body 200 can be partial or complete. When the deformable body 200 is fully deformed, when it is deformed from the proximal end to the distal end of the deformable body 200 to a contracted state, the outer surface of the deformable body 200 forms a relatively continuous and smooth arc surface, and the distal end of the deformable body 200 is small enough to make it easier to pass through when encountering a blood vessel bifurcation.

[0043] In some embodiments, when the adjustment component 300 is not installed, the diameter of the deformable body 200 is the same as the diameter of the catheter body 100 and is connected end to end, wherein the end of the deformable body 200 is connected and fixed to the end of the catheter body 100 by heat welding. Part of the adjustment component 300 is hidden inside the deformable body 200.

[0044] In some embodiments, the material of the deformable body 200 can be medical rubber, and of course the deformable body 200 can also be made of silicone, TPU, biocompatible polyurethane and other materials.

[0045] The diameter of the deformable body 200 is adjusted by adjusting the component 300, so that the diameter of at least a part of the deformable body 200 gradually decreases from the proximal direction to the distal direction. During the advancement of the catheter, the deformable body 200 maintains a smaller size, which facilitates the advancement of the catheter and the passage through the bifurcation of the blood vessel, prevents damage to the blood vessel wall due to the windowsill effect, and also facilitates the operator's operation and reduces the difficulty of intervention.

[0046] When the deformable body 200 is in place, the diameter of at least a portion of the deformable body 200 can be gradually increased from the proximal direction to the distal direction through the adjustment component 300 until the distal edge of the deformable body 200 fits the blood vessel wall. The increase in the size of the deformable body 200 allows a larger suction area to be obtained during the suction process, greatly improving the suction efficiency and thrombus removal effect, shortening the operation time, and reducing the surgical risk.

[0047] The deformable body 200 in the expanded state can generate a greater suction force in a catheter with a tube body as small as possible, so as to successfully remove the thrombus and reduce the impact on the blood vessels and blood flow.

[0048] In some embodiments, the adjustment assembly 300 includes an adjustment member and an electric heating element, such as Figures 4 to 6 As shown, a plurality of adjusting members are arranged in a circular array with the central axis of the deformable body 200 as the center, so that the deformation of the deformable body 200 is more uniform and smooth.

[0049] The adjusting member is arranged along the axial direction of the deformable body 200, and the distal end of the adjusting member is inclined toward the central axis direction of the deformable body 200, so that in the initial state, the deformable body 200 is in a contracted state, and the electric heating element is used to drive the distal end of the adjusting member to change from being inclined toward the central axis direction of the deformable body 200 to being inclined toward the central axis direction away from the deformable body 200. The inclination direction of the distal end of the adjusting member is changed by the electric heating element, so that the deformable body 200 can switch between the contracted state and the expanded state.

[0050] In some embodiments, the deformable body 200 is provided with a deformation channel 210 for placing an adjusting member, and the deformation channel 210 extends from the proximal end to the distal end of the deformable body 200. There is a gap between the deformation channel 210 and the adjusting member so that there is enough space for the adjusting member to change its state, making the adjustment of the adjusting member smoother.

[0051] In some examples, the adjusting member is made of a memory alloy 310, the memory alloy 310 is made into a rod, and the electric heating element is used to heat the adjusting member so that the inclined part of the adjusting member rotates.

[0052] The memory alloy 310 may be made of nickel-titanium alloy. At normal temperature, the distal end of the memory alloy 310 is tilted toward the central axis of the deformable body 200. When the shape needs to be switched, the memory alloy 310 is heated to a certain temperature range by an electric heating element to cause the memory alloy 310 to undergo plastic deformation. In the embodiment of the present application, the heated memory alloy 310 rotates, causing the distal end of the memory alloy 310 to undergo plastic deformation from being tilted toward the central axis of the deformable body 200 to being tilted away from the central axis of the deformable body 200, thereby causing the deformable body 200 to change from a contracted state to an expanded state.

[0053] In some specific embodiments, the length of the deformation body 200 can be set to 2 to 20 mm, and a temperature control channel is set in the deformation channel 210 or the catheter body 100. The temperature control channel is used to transfer cold energy or heat energy. The middle of the temperature control channel is a heat transfer wire, and the heat transfer wire is wrapped with heat-resistant material. The electric heating element transfers heat to the memory alloy 310 through the heat transfer wire. In some embodiments, a thermocouple can also be provided. The thermocouple is attached to the memory alloy 310 and connected to the proximal end of the catheter through a wire. The temperature control channel and the thermocouple can be one or more. The heating temperature of the memory alloy 310 can be accurately controlled by cooperating with the thermocouple and the electric heating element.

[0054] In some specific embodiments, the steering angle of the adjusting member is set to 160° to 180°, that is, when the memory alloy 310 is heated to a certain temperature range, such as Figure 7 As shown, the memory alloy 310 can produce a turning action, and the turning angle range of each memory alloy 310 is 160° to 180°, ensuring that the deformation body 200 can change from a contracted state to an expanded state.

[0055] In some embodiments, the adjusting member is a deformable spring, which includes a first section 322 and a second section 323. One end of the first section 322 and one end of the second section 323 are connected and extend to the distal end near the deformable body 200. The other end of the first section 322 or the other end of the second section 323 is connected to a pulling power input source provided inside and / or outside the catheter body 100.

[0056] Furthermore, one end connecting the first section 322 and the second section 323 can be fixed to the distal end of the deformable body 200, and the first section 322 and the second section 323 can be relatively displaced to control the shape of the deformable spring, thereby driving the distal end of the deformable body 200 to adjust from a contracted state to an expanded state through the shape change of the deformable spring.

[0057] In some embodiments, Figure 8 and Fig. 9As shown, the second section 323 has a straight portion, and part of the first section 322 is wound outside the straight portion. The straight portion is in the deformation channel 210, and the part of the first section 322 in the deformation channel 210 is wound outside the straight portion to form a spiral winding portion 3221. Under normal conditions, the spiral winding portion 3221 works to maintain the deformation body 200 in a contracted state. When the deformation body 200 needs to be transformed into an expanded state, the first section 322 is pulled toward the proximal end of the catheter body 100, and the second section 323 is pushed toward the distal end of the catheter body 100. Through the relative displacement of the first section 322 and the second section 323, the straight section pushes the distal end of the deformation body 200 from the retracted state to the open state, and cooperates with the pulling of the spiral winding portion 3221 to enable the distal end of the deformation body 200 to be deformed to the expanded state.

[0058] In some embodiments, in order to protect the deformed spring, a micro-catheter 321 may be further provided, and the micro-catheter 321 is used to wrap the first section 322 and the second section 323 located at the catheter body 100 .

[0059] In some embodiments, the pulling power of the first section 322 or the second section 323 can be provided by an axial moving device arranged at the proximal end of the catheter. In particular, it can be a solution of converting spiral motion to linear motion, so that the axial displacement of the tube section outside the human body can be simply and conveniently adjusted to the wire drawing.

[0060] In some embodiments, the outer surfaces of all parts may be coated with a hydrophilic coating or a hydrophobic coating.

[0061] In some embodiments, the catheter body 100 can be a multi-layer structure, and the catheter body 100 can be composed of an inner lining layer, a spring winding layer and (or) a braided layer, and an outer tube layer. According to the product positioning requirements, the structures from inside to outside are ①, inner lining layer-spring winding layer-braided layer-outer tube layer; ②, inner lining layer-spring winding layer-outer tube layer; ③, inner lining layer-braided layer-outer tube layer.

[0062] In some specific embodiments, the inner layer of the catheter body 100 can be formed of PTFE (polytetrafluoroethylene) or HDPE (high-density polyethylene) or PEBAX (block polyetheramide resin) mixed with a low friction coefficient additive to reduce the friction of the inner layer. The middle layer can be a spring-wound structure with metal wire, or a braided structure with metal wire, or a composite structure formed by first winding the spring and then braiding. The outer layer can be made of nylon elastomer (e.g., PEBAX), nylon or PU (polyurethane).

[0063] In some embodiments, a developing component is provided at the distal edge of the deformable body 200, and the material of the developing component is one or more of gold, platinum, tantalum, and iridium. In some specific embodiments, the deformable body 200 may be mixed with metal powder that can be used for developing during manufacturing, or a developing component for developing may be circumferentially bonded or embedded at the distal edge of the deformable body 200 to facilitate the positioning of the end position of the catheter during use.

[0064] The present application also provides a method for using the above-mentioned catheter with a changeable end state, and the specific operation steps are as follows:

[0065] Under normal conditions, after the adjustment group is assembled, the deformable body 200 is maintained in a contracted state under the action of the adjustment assembly 300, so that the diameter of at least part of the deformable body 200 gradually decreases from the proximal direction to the distal direction, which facilitates the advancement of the catheter;

[0066] The catheter body 100 with the deformable body 200 is introduced through the radial artery or the femoral artery, and the deformable body 200 in the contracted state guides the catheter body 100 through the bifurcation of the blood vessel to approach the lesion position of the target blood vessel;

[0067] Using the adjustment component 300, the deformable body 200 is changed from a contracted state to an expanded state, and the diameter of at least a portion of the deformable body 200 in the expanded state gradually increases from the proximal direction to the distal direction, so that the distal edge of the deformable body 200 is close to the blood vessel wall;

[0068] The external device providing suction force starts the suction work, and the thrombus enters the catheter body 100 under the guidance of the deformable body 200, and then is drawn out of the blood vessel through the catheter body 100;

[0069] The external device providing suction force stops the suction work, and then the adjustment component 300 is used to adjust the deformable body 200 from the expanded state to the contracted state;

[0070] The catheter body 100 having the deformed body 200 is removed from the human body.

[0071] The embodiments of the present application are described in detail above in conjunction with the accompanying drawings, but the present application is not limited to the above embodiments, and various changes can be made within the knowledge scope of ordinary technicians in the technical field without departing from the purpose of the present application.

Claims

1. A catheter with a changeable end, characterized in that: include The catheter body; A deformation body, disposed at the distal end of the catheter body; The adjustment component is used to adjust the diameter of the deformation body so that the diameter of at least a part of the deformation body gradually decreases from the proximal direction to the distal direction, or the diameter of at least a part of the deformation body gradually increases from the proximal direction to the distal direction.

2. The catheter with a changeable end state according to claim 1, characterized in that: The diameter of the deformation body is the same as the diameter of the catheter body and is connected end to end, and part of the adjustment component is hidden inside the deformation body.

3. The catheter with a changeable end state according to claim 2, characterized in that: The adjustment component includes an adjustment member and an electric heating element. A plurality of the adjustment members are arranged in a circular array with the central axis of the deformable body as the center. The adjustment member is set along the axial direction of the deformable body, and the distal end of the adjustment member is inclined toward the central axis of the deformable body. The electric heating element is used to drive the distal end of the adjustment member to change from being inclined toward the central axis of the deformable body to being inclined toward the direction away from the central axis of the deformable body.

4. The catheter with a changeable end state according to claim 3, characterized in that: The adjusting member is made of a memory alloy, and the electric heating element is used to heat the adjusting member so as to cause the inclined portion of the adjusting member to rotate.

5. The catheter with a changeable end state according to claim 4, characterized in that: The steering angle of the adjusting member is set to 160° to 180°.

6. The catheter with a changeable end state according to claim 3, characterized in that: The adjusting member is a deformable spring, which includes a first section and a second section. One end of the first section and one end of the second section are connected and extend to a distal end close to the deformable body. The other end of the first section or the other end of the second section is connected to a pulling power input source provided inside and / or outside the catheter body.

7. The catheter with a changeable end state according to claim 6, characterized in that: The second section has a straight portion, and a portion of the first section is disposed around the straight portion.

8. The catheter with a changeable end state according to any one of claims 2 to 7, characterized in that: The deformation body is provided with a channel for accommodating the adjusting member, and a gap is provided between the channel and the adjusting member.

9. The catheter with a changeable end state according to any one of claims 2 to 7, characterized in that: A developing component is disposed at the distal edge of the deformable body, and the developing component is made of one or more of gold, platinum, tantalum, and iridium.

10. A method for using a catheter, based on the catheter with a changeable tip state as claimed in any one of claims 1 to 9, characterized in that: The steps include: The deformation body is maintained in a contracted state under the action of the adjustment component, so that the diameter of at least a portion of the deformation body gradually decreases from the proximal direction to the distal direction; The catheter body with the deformable body is introduced through the radial artery or the femoral artery, and the deformable body in the contracted state guides the catheter body through the bifurcation of the blood vessel to approach the lesion position of the target blood vessel; Using the adjustment component, the deformable body is changed from a contracted state to an expanded state, wherein the diameter of at least a portion of the deformable body in the expanded state gradually increases from the proximal direction to the distal direction, so that the distal edge of the deformable body is close to the blood vessel wall; The external device providing suction force starts the suction operation, and the thrombus enters the catheter body under the guidance of the deformable body, and then is drawn out of the blood vessel through the catheter body; The external device providing suction force stops the suction work, and then the adjustment component is used to adjust the deformable body from the expanded state to the contracted state; The catheter body having the deformed body is removed from the human body.

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