Shapeable guide device and system
By combining the temperature-sensitive element and energy conversion element of the shape-adjustable guide device, precise shaping and shape retention of guidewires and catheters are achieved, solving the problem of inaccurate shaping in existing technologies and improving the success rate and safety of the surgery.
Patent Information
- Application Number
- CN202422464963.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-10-12
- Publication Date
- 2025-12-12
- Estimated Expiration
- 2034-10-12
AI Technical Summary
Existing guidewires and catheters lack precise control and repeatability during surgery, making it difficult to achieve complex or delicate shape shaping, which affects the structural integrity and performance of the instruments.
The device employs a malleable guide device, which includes slender components and temperature-sensitive elements. Electrical energy is input through an energy conversion element to shape the molding section at a specific temperature and maintain its shape after cooling. Precise control is achieved by utilizing the phase change characteristics of the temperature-sensitive material.
It achieves precise control over the shaping process, improves the accuracy and repeatability of shaping, and enables personalized shaping based on the differences in the patient's anatomical structure, adapting to complex or delicate shape requirements.
Smart Images
Figure CN223653860U_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The utility model relates to the field of medical instruments for heart surgery, and particularly relates to a shapeable guiding device and system. BACKGROUND
[0002] Interventional surgery is a modern minimally invasive treatment technology, which reduces trauma and risk through image-guided precise operation, and is widely used in the treatment of cardiovascular diseases, tumors and other fields. With its precision and safety, interventional surgery has become the preferred treatment for many diseases, significantly improving the recovery speed and quality of life of patients. Among them, the guide wire and the catheter play a key role in interventional surgery. The guide wire guides the catheter, sheath tube, balloon, stent and other instruments through the blood vessel and body cavity path to ensure that they accurately reach the target position. These functions make the guide wire and the catheter indispensable core tools in modern minimally invasive surgery, greatly improving the success rate of surgery and the safety of patients.
[0003] At present, most of the guide wires and catheters on the market are designed in different sizes and shapes to adapt to different anatomical structures and surgical needs of patients. Due to the significant differences in the morphology, size and pathological conditions of the blood vessels, digestive tract, urinary tract and other anatomical structures in the human body, the guide wire and the catheter need to be designed in a variety of ways to improve their passability, safety and operation accuracy. However, despite the various pre-designed sizes and shapes of guide wires and catheters, due to the significant differences in the anatomical structures of patients, doctors often need to manually shape the guide wire / catheter according to the specific situation, which is called "post-shaping". This post-shaping operation can better adapt to the anatomical characteristics of individual patients, such as complex blood vessel running, abnormal tissue structure or special conditions of the lesion area.
[0004] In the prior art, the guide wire post-shaping is often shaped by hand, which utilizes the ductility of metal; the post-shaping of the catheter at the operation site is often shaped by "shaping needle + high-temperature fumigation", which utilizes the ductility of metal and the thermoplasticity of high polymer materials. Both lack precise control and repeatability in the shaping process, making it difficult to achieve complex or delicate shapes, and repeated manual shaping may affect the structural integrity and performance of the instrument. UTILITY MODEL CONTENT
[0005] The utility model discloses a shapeable guiding device and system, which aims to solve the technical problems existing in the prior art.
[0006] The utility model adopts the following technical scheme:
[0007] On the one hand, the utility model provides a shapeable guiding device, including the slender member, the slender member includes the input section setting in the proximal end and the shaping section setting in the distal end;
[0008] The input section is configured to receive electrical energy;
[0009] The shaping section comprises a temperature-sensitive element and an energy conversion element, the temperature-sensitive element comprises a temperature-sensitive material with a phase transition temperature higher than human body temperature, the energy conversion element is coupled with the input section and is in contact or non-contact with the temperature-sensitive element;
[0010] When the energy conversion element receives electrical energy, the temperature of the shaping section is raised above the phase transition temperature of the temperature-sensitive element, so that the shaping section can be shaped; when the energy conversion element stops receiving electrical energy, the temperature of the shaping section is lowered below the phase transition temperature of the temperature-sensitive element, so that the shaping section maintains the shape after shaping.
[0011] As a preferred technical solution, the input section comprises:
[0012] - an electrode arranged on the outer surface of the elongated member;
[0013] - a wire cavity arranged inside the elongated member;
[0014] - a wire arranged in the wire cavity, the proximal end of the wire is electrically connected with the electrode, and the distal end of the wire extends to the shaping section and is electrically connected with the energy conversion element;
[0015] - an insulating layer covering the outer surface of the elongated member except the electrode.
[0016] As a preferred technical solution, the electrode comprises a first electrode and a second electrode, which are arranged on the outer surface of the elongated member respectively; the wire comprises a first wire and a second wire, which are arranged in the wire cavity respectively;
[0017] The proximal end of the first wire is electrically connected with the first electrode, and the proximal end of the second wire is electrically connected with the second electrode; the distal ends of the first wire and the second wire both extend to the shaping section and are electrically connected with the energy conversion element, forming a closed loop.
[0018] As a preferred technical solution, the energy conversion element comprises an electric heating wire, the electric heating wire extends along the length direction of the temperature-sensitive element and is arranged on the outer periphery and / or inside of the temperature-sensitive element;
[0019] The electric heating wire is configured in a straight line, a spiral or a mesh.
[0020] As a preferred technical solution, the structure of the temperature-sensitive element comprises at least one of a solid column structure, a hollow tubular structure or a porous structure.
[0021] As a preferred technical solution, the material of the temperature-sensitive element comprises at least one of polyamide, polyformaldehyde, polyether ether ketone, polyurethane, thermoplastic polyurethane, block polyether amide, polycaprolactone or cross-linked polyethylene.
[0022] As a preferred technical solution, the elongated member is configured as a shapeable guide wire.
[0023] As a preferred technical solution, the shapeable guide wire further comprises a pushing segment, the pushing segment is arranged at the proximal end of the elongated member and is located at the proximal end side of the input segment.
[0024] The pushing segment comprises a metal material for transmitting a pushing force.
[0025] As a preferred technical solution, the elongated member is configured as a shapeable catheter, the shapeable catheter is arranged through from the proximal end to the distal end.
[0026] As a preferred technical solution, the shapeable catheter further comprises a proximal handle, at least a part of the input segment is arranged in the proximal handle.
[0027] In another aspect, the utility model also provides a shapeable guide system, the shapeable guide system comprises at least one shapeable guide device as any one of the above.
[0028] As a preferred technical solution, the shapeable guide system comprises two shapeable guide devices, the two shapeable guide devices are respectively configured as a shapeable guide wire and a shapeable catheter, the shapeable guide wire can be arranged in the shapeable catheter.
[0029] The technical scheme adopted by the utility model can achieve the following beneficial effects:
[0030] The utility model mainly provides a shapeable guide device and system, wherein, the shapeable guide device comprises an elongated member, the elongated member can be a shapeable guide wire or catheter, the elongated member comprises an input segment arranged at the proximal end and a shaping segment arranged at the distal end, wherein, the input segment can input current, the shaping segment realizes the accurate control to the shaping process through the combination of temperature-sensitive element and energy conversion element, the temperature-sensitive element makes the shaping segment can shape at specific temperature, need not complex manual skill to create more complex and fine shape based on model, and keep shape after cooling, greatly improve the accuracy and repeatability of shaping, and can make the elongated member individualize according to the specific situation of each patient, can better adapt to the anatomical structure difference of different patients. BRIEF DESCRIPTION OF DRAWINGS
[0031] In order to more clearly illustrate the technical scheme of the embodiment of the utility model, the following will be briefly introduced to the drawing needed to be used in the embodiment description, constitutes the part of the utility model, the illustrative embodiment of the utility model and its explanation explain the utility model, and do not constitute the improper limitation of the utility model. In the drawings:
[0032] Figure 1A structure schematic view of the shapeable guide wire in an embodiment disclosed by the utility model embodiment 1 is shown in the figure.
[0033] Figure 2 A power-on state schematic view of the shapeable guide wire in an embodiment disclosed by the utility model embodiment 1 is shown in the figure.
[0034] Figure 3 A structure schematic view of the shapeable guide wire in an embodiment disclosed by the utility model embodiment 1 is shown in the figure.
[0035] Figure 4 A structure schematic view of the shapeable guide wire in an embodiment disclosed by the utility model embodiment 1 is shown in the figure. Figure 3
[0036] Figure 5 A structure schematic view of the shapeable guide wire in an embodiment disclosed by the utility model embodiment 1 is shown in the figure.
[0037] Figure 6 A structure schematic view of the shapeable guide wire in an embodiment disclosed by the utility model embodiment 1 is shown in the figure. Figure 5
[0038] A structure schematic view of the shapeable guide wire in an embodiment disclosed by the utility model embodiment 1 is shown in the figure. Figure 7
[0039] A structure schematic view of the shapeable guide wire in an embodiment disclosed by the utility model embodiment 1 is shown in the figure. Figure 8
[0040] A structure schematic view of the shapeable guide wire in an embodiment disclosed by the utility model embodiment 1 is shown in the figure. Figure 9
[0041] A structure schematic view of the shapeable guide wire in an embodiment disclosed by the utility model embodiment 1 is shown in the figure. Figure 10
[0042] A structure schematic view of the shapeable guide wire in an embodiment disclosed by the utility model embodiment 1 is shown in the figure. Figure 11
[0043] A structure schematic view of the shapeable guide wire in an embodiment disclosed by the utility model embodiment 1 is shown in the figure. Figure 12
[0044] Explanation of reference signs:
[0045] Input section 10, wire cavity 11, wire 12, electrode 20, shaping section 30, temperature-sensitive element 31, energy conversion element 32, pushing section 40, proximal handle 50, hemostasis structure 51, liquid line passage 52, power supply clamp 61, external power supply line 62. Specific implementation
[0046] In order to make the purpose, technical scheme and advantages of the utility model clearer, the utility model technical scheme will be described clearly and completely below by combining the utility model specific embodiments and corresponding drawings. In the description of the utility model, it needs to be explained that the term "or" is usually used in the meaning of including "and / or", unless the content is explicitly indicated otherwise.
[0047] In the description of the utility model, it needs to be explained that, unless explicitly specified and limited, the terms "mounting", "connecting" and "connection" should be understood broadly. In addition, in the description of the present application, the terms "first", "second" and the like are only used for distinguishing description, and cannot be understood as indicating or implying relative importance. The "proximal end" in the description refers to the end close to the operator along the length direction of the shapeable guide device, and the "distal end" refers to the end away from the operator along the length direction of the shapeable guide device. The "spiral", "net", "straight line", "column", "tubular" and the like as described in the text are not absolute or standard shapes, and can also be approximately related shapes and the like. Those skilled in the art can know that, in order to realize respective functions and meet the requirements of surgical operation, the specific shape / dimension / angle of each structure can be adjusted adaptively.
[0048] Obviously, the described embodiments are only part of the embodiments of the utility model, not all the embodiments. Based on the embodiments in the utility model, all other embodiments obtained by those skilled in the art without creative labor belong to the protection scope of the utility model.
[0049] Example 1
[0050] Reference Figure 1 - Figure 9 The present embodiment provides a shapeable guide device which can be shaped into a specific angle or shape to adapt to the anatomical structure of the patient's blood vessels or other body passages and guide the subsequent interventional instruments to reach the target position along the predetermined path.
[0051] In some embodiments, the shapeable guide device is an elongated member which is specifically configured as a shapeable guide wire. In the present embodiment, the specifications and application scenarios of the shapeable guide wire are no longer specifically limited, and those skilled in the art can adjust its length or diameter according to different target interventional positions as needed, and can also apply it to specific blood vessels or other lumens according to different specific interventional procedures of the patient.
[0052] As Figure 1In some embodiments, the shapeable guide wire comprises, from proximal end to distal end, a pushing section 40, an input section 10 and a shaping section 30, wherein the pushing section 40 is used for transmitting pushing force, the input section 10 is used for inputting electric energy, and the shaping section 30 is used for heating and shaping into a specific shape after being electrified, and maintaining the specific shape after cooling.
[0053] In some embodiments, the pushing section 40 comprises a metal material to ensure effective force transmission of the shapeable guide wire from proximal end to distal end, so that the doctor can accurately control the advancing and retreating of the shapeable guide wire. Specifically, the pushing section 40 can be selected from the same metal materials as conventional guide wires, such as medical stainless steel, platinum-nickel alloy, nickel-titanium alloy, cobalt-chromium alloy or tungsten alloy, etc., which are not specifically limited in the present embodiment.
[0054] In some embodiments, the input section 10 comprises an electrode 20, a wire cavity 11, a wire 12 and an insulating layer, wherein the electrode 20 is exposed to the outer surface of the input section 10 and comprises a first electrode and a second electrode with opposite polarities; the wire cavity 11 is arranged inside the shapeable guide wire and extends to the distal end; the wire 12 is arranged in the wire cavity 11 and comprises a first wire and a second wire, the proximal end of the first wire is electrically connected to the first electrode, and the proximal end of the second wire is electrically connected to the second electrode, and the distal ends of the two wires 12 extend to the shaping section 30; the insulating layer covers the outer surface of the input section 10, but does not cover the first electrode and the second electrode.
[0055] In some embodiments, one of the first electrode and the second electrode is positive, and the other is negative, and the two electrodes 20 are kept at an appropriate distance to prevent short circuit; the shapes of the two electrodes 20 can be configured based on the specifications of the shapeable guide wire, and can be configured as a ring shape, a strip shape or other geometric shapes, which are not specifically limited herein.
[0056] As shown in FIG. 2, the shapeable guide wire comprises an input section 10, a pushing section 40 and a shaping section 30, wherein the input section 10 is used for inputting electric energy, the pushing section 40 is used for transmitting pushing force, and the shaping section 30 is used for heating and shaping into a specific shape after being electrified, and maintaining the specific shape after cooling. Figure 2 When electrified, the power clamp 61 is clamped to the outer periphery of the input end, and the two external power supply lines 62 of the power clamp 61 are respectively connected to the first electrode and the second electrode.
[0057] In some embodiments, the wire cavity 11 extends from the input section 10 to the distal end until the shaping section 30, and can be arranged as a single cavity or separated into two independent cavities for providing protection and guidance for the first wire and the second wire, while maintaining the integrity of the overall structure of the shapeable guide wire.
[0058] In some embodiments, the first wire and the second wire are provided with a thin layer of insulating coating to prevent short circuit caused by mutual contact; the thickness of the insulating layer on the outside of the input section 10 needs to be thin enough to avoid affecting the overall diameter of the shapeable guide wire, but also to ensure that effective insulation performance can be provided.
[0059] In some embodiments, the lead 12 can extend linearly, as shown in FIG. 1A Figure 5 , Figure 6 or extend spirally, as shown in FIG. 1B Figure 3 , Figure 4 The shape of the lead 12 is not limited in the present embodiments
[0060] In some embodiments, the shaping section 30 comprises a temperature-sensitive element 31 and an energy conversion element 32. The temperature-sensitive element 31 comprises a temperature-sensitive material with a phase transition temperature higher than the human body temperature. The proximal end of the energy conversion element 32 is coupled to the distal end of the first lead and the second lead respectively, forming a closed loop. The energy conversion element 32 is in contact or non-contact with the temperature-sensitive element 31. When the energy conversion element 32 receives electric energy, the temperature of the shaping section 30 rises above the phase transition temperature of the temperature-sensitive element 31, so that the shaping section 30 can be shaped. When the energy conversion element 32 stops receiving electric energy, the temperature of the shaping section 30 decreases below the phase transition temperature of the temperature-sensitive element 31, so that the shaping section 30 maintains the shape after shaping.
[0061] In some embodiments, the shaping section 30 can further comprise a braided wire or other filler according to the application requirements, and can further comprise a developing ring according to the functional requirements.
[0062] In some embodiments, the energy conversion element 32 is configured as an electric heating wire extending along the length direction of the temperature-sensitive element 31, which can be configured as a straight line, a spiral or a mesh. When the electric heating wire is configured as different shapes, the heat transfer effect and mechanical performance are slightly different, so the person skilled in the art can select according to the actual operation requirements. The temperature-sensitive element 31 is wrapped outside the electric heating wire, which can be configured as a solid column structure, a hollow tubular structure or a porous structure. The temperature of the electric heating wire rises after being electrified. The molecular chain movement ability of the temperature-sensitive element 31 differs before and after its phase transition temperature. The shaping and setting can be performed by using this performance.
[0063] In some embodiments, the temperature of the electric heating wire can be adjusted by inputting the size of the electric current, so that it can accurately rise to the phase transition temperature of the temperature-sensitive material. Alternatively, the electric heating wire can be pre-calibrated for the resistance-temperature relationship, or the electric heating wire material with a stable resistance-temperature coefficient can be selected. The temperature of the electric heating wire can be calculated by monitoring the resistance change, so that it can rise to the phase transition temperature of the temperature-sensitive material.
[0064] In other embodiments, a temperature sensor is further provided between the electric heating wire and the temperature-sensitive element 31. The temperature of the electric heating wire is monitored by the temperature sensor, so that it can rise to the phase transition temperature of the temperature-sensitive material. Specifically, the specific specifications and models of the temperature sensor are not limited in the present embodiments. The person skilled in the art can set according to the actual specifications of the temperature-sensitive element 31.
[0065] In some embodiments, the temperature-sensitive material includes a crystalline polymer material and an amorphous polymer material, wherein the crystalline polymer material has a clear melting point, at which the crystal structure collapses, so its phase transition temperature is the crystallization temperature, and the amorphous polymer material has no clear melting point, and its phase transition temperature is the glass transition temperature, at which the material changes from a rigid glass state to a flexible rubber state. Specifically, the material of the temperature-sensitive element 31 can be at least one of polyamide, polyformaldehyde, polyether ether ketone, polyurethane, thermoplastic polyurethane, block polyether amide, polycaprolactone, or cross-linked polyethylene, and different materials have different hardness, which can be selected according to the use scenario.
[0066] Specifically, taking the amorphous polymer material as an example, the working principle of the temperature-sensitive element 31 is described as follows: under the action of heat, the polymer material is heated to above its glass transition temperature, and the molecular chain segments can move, and under the synergistic action of the molecular chain segments, the molecular chain can move in a curled, straightened, and rotated manner, but the chain segment movement in this deformation process is reversible, and the material is in a rubber state, so when a certain external force acts, the material can change from an initial shape to a target shape. When the external force is maintained to maintain the target shape, and the temperature decreases to below the glass transition temperature, the material molecular chain segments gradually freeze and cannot move, and the material will remain in the target shape. In addition, some temperature-sensitive polymer materials also have a certain shape memory effect, that is, when the temperature is again raised to above the glass transition temperature in the target shape state, the material can recover to the initial shape.
[0067] In some embodiments, the phase transition temperature of the temperature-sensitive element 31 is set based on the actual selected material, for example, the polyether ether ketone is selected at 170-200°C, the polyformaldehyde is selected at 120-135°C, and the polyurethane, thermoplastic polyurethane, and block polyether amide are selected at 60-80°C.
[0068] In some embodiments, different temperature-sensitive materials not only have different phase transition temperatures, but also have different moduli before and after the phase transition temperature. The modulus size affects the performance of the shaping section 30 in terms of retention and support, and the temperature-sensitive material also needs to have a certain elasticity and flexibility at room temperature and body temperature to facilitate pushing through the catheter. Therefore, different modulus materials need to be selected according to different use scenarios, for example, when the shapeable guide wire is applied to aortic valve replacement surgery, the shaping section 30 needs to have a certain retention and support at body temperature, so the temperature-sensitive material needs to have a relatively high elastic modulus at body temperature; when the shapeable guide wire is applied to some coronary and neural interventional surgeries, the shaping section 30 needs to be flexible at body temperature, so the temperature-sensitive material does not need a relatively high elastic modulus.
[0069] In this embodiment, the shapeable guide wire first determines the required shape before the operation, such as Figure 7— Figure 9 Meanwhile, the power supply is connected to heat it up, and when the temperature is raised above the phase transition temperature, the operator shapes the shaping section 30, and then rapidly cools it down below the phase transition temperature by water cooling, air cooling, etc., to keep the shape of the shaping section 30.
[0070] Specifically, the shaping can be purely manual under a medical glove in the operating room, and in order to obtain more accurate or complex structures, a shaping model (such as a 3D printed model, a pipe model, etc.) can also be prepared in advance, brought into the operating room after sterilization is completed, and then the shapeable guide wire is inserted into the shaping model, and then the operation of heating and shaping and cooling and setting is performed.
[0071] Example 2
[0072] Reference Figure 10 — Figure 12 The embodiment provides a shapeable guide device which can be shaped into a specific angle or shape before the operation to adapt to the anatomical structure of the blood vessels or other internal passages of the patient and guide the subsequent interventional instruments to reach the target position along the predetermined path.
[0073] In some embodiments, the shapeable guide device is an elongated member, which is configured as a shapeable catheter, and the shapeable catheter is provided with a through cavity in the middle from the proximal end to the distal end for providing an instrument passage; in this embodiment, the specification and application scenarios of the shapeable catheter are no longer specifically limited.
[0074] As Figure 10 In some embodiments, the shapeable catheter sequentially comprises a proximal handle 50, an input section 10 and a shaping section 30 from the proximal end to the distal end, wherein the proximal handle 50 can be provided with a hemostasis structure 51, a liquid pipeline passage 52, etc., and the main functions are hemostasis and liquid injection; the input section 10 is used for transmitting current, and the shaping section 30 is used for heating and shaping into a specific shape after being powered on, and maintaining the specific shape when being cooled.
[0075] In some embodiments, the input section 10 at least comprises a wire cavity 11 and a wire 12, and in order to input current, the proximal end or the proximal handle 50 of the input section 10 is also provided with an electrode 20, and more preferably, the electrode 20 is exposed to the outer surface of the proximal handle 50, so that the integration of the proximal handle 50 is higher, the risk of current leakage or short circuit is reduced, and at the same time, the doctor can quickly connect or disconnect the external power supply, while the input section 10 and the shaping section 30 focus on providing a stable instrument passage, and the shaping section 30 also provides the performance of shaping.
[0076] In some embodiments, the electrode 20 comprises a first electrode and a second electrode, which are respectively configured as a positive electrode and a negative electrode and are arranged at intervals to avoid short circuit.
[0077] In some embodiments, the input section 10 is configured as a double-lumen structure, in the cross-sectional structure of the input section 10, two lumens are arranged concentrically, the inner lumen can pass through the guide wire and other interventional instruments, and the outer lumen is the guide wire lumen 11 for arranging the guide wire 12; the guide wire 12 includes a first guide wire and a second guide wire, the proximal end of the first guide wire is electrically connected to the first electrode, and the proximal end of the second guide wire is electrically connected to the second electrode, and the distal ends of the two guide wires 12 extend to the shaping section 30; optionally, the surfaces of the first guide wire and the second guide wire are provided with a thin layer of insulating coating to prevent short circuit caused by mutual contact, and an insulating layer is also coated on the outer surface of the input section 10.
[0078] In some embodiments, the shaping section 30 includes a temperature-sensitive element 31 and an energy conversion element 32, the temperature-sensitive element 31 includes a temperature-sensitive material with a phase transition temperature higher than the human body temperature, the proximal end of the energy conversion element 32 is coupled to the distal end of the first guide wire and the second guide wire respectively to form a closed loop, and the energy conversion element 32 is in contact or non-contact composite with the temperature-sensitive element 31; optionally, the first guide wire and the second guide wire can be coupled to the energy conversion element 32 at the proximal end of the shaping section 30, at this time, the two ends of the energy conversion element 32 are located at the proximal end of the shaping section 30, as shown in Figure 11 , or one of the first guide wire and the second guide wire is coupled to the energy conversion element 32 at the proximal end of the shaping section 30, and the other extends to the distal end of the shaping section 30 and is coupled to the energy conversion element 32, as shown in Figure 12 , at this time, the two ends of the energy conversion element 32 are located at the proximal end and the distal end of the shaping section 30 respectively.
[0079] When the energy conversion element 32 receives electric energy, the temperature of the shaping section 30 is raised to above the phase transition temperature of the temperature-sensitive element 31, so that the shaping section 30 can be shaped; when the energy conversion element 32 stops receiving electric energy, the temperature of the shaping section 30 is lowered to below the phase transition temperature of the temperature-sensitive element 31, so that the shaping section 30 maintains the shape after shaping, which can be referred to Figure 7 Figure 9 .
[0080] In some embodiments, the shaping section 30 can also be compounded with braided wires or other fillers according to application requirements, and can also be compounded with developing rings according to functional needs.
[0081] In some embodiments, the shaping section 30 is also configured as a double-lumen structure as the input section 10, with two concentric lumens, the inner lumen capable of passing through the guidewire and other interventional instruments, and the outer lumen for arranging the energy conversion element 32 and the temperature-sensitive element 31; alternatively, the temperature-sensitive element 31 can be filled in the outer lumen, or the outer lumen itself is made of the temperature-sensitive element 31, which has a hollow tubular structure or a porous tubular structure; the energy conversion element 32 is configured as an electric heating wire, which extends along the length direction of the temperature-sensitive element 31, and can be configured as a straight line, a double helix, a single helix, or a mesh; when the electric heating wire is configured in different shapes, the heat transfer effect and mechanical performance are slightly different, so the person skilled in the art can select according to the actual operation requirements. The temperature of the electric heating wire rises after being electrified, and the molecular chain movement ability of the temperature-sensitive element 31 differs before and after the phase transition temperature, which is used to shape and set the shape of the shaping section 30.
[0082] In some embodiments, the material selection and elastic modulus selection of the temperature-sensitive element 31 are the same as those in Embodiment 1 described above, which will not be repeated here.
[0083] In this embodiment, the shapeable catheter is first determined before the operation, and then connected to the power supply for heating. When the temperature rises above the phase transition temperature, the operator shapes the shaping section 30, and then rapidly cools it to below the phase transition temperature by water cooling, air cooling, etc., to keep the shape of the shaping section 30.
[0084] Specifically, the shaping can be performed manually under a medical glove in the operating room. In order to obtain more accurate or complex structures, a shaping model (such as a 3D printed model, a pipe model, etc.) can also be prepared in advance, which is brought into the operating room after sterilization, and then the shapeable catheter is inserted into the shaping model, and the operation of heating shaping and cooling setting is performed.
[0085] Example 3
[0086] This embodiment provides a shapeable guide system, which at least includes a shapeable guide device as described in Embodiment 1 or Embodiment 2. The technical features described in the foregoing embodiments are naturally inherited in this embodiment, and will not be repeated here.
[0087] In some embodiments, the shapeable guide system includes a shapeable guide wire as described in Embodiment 1 and a conventional catheter, which are used together.
[0088] In some embodiments, the shapeable guide system includes a shapeable catheter as described in Embodiment 2 and a conventional guide wire, which are used together.
[0089] In other embodiments, the shapeable guide system includes a shapeable guide wire as described in embodiment 1 and a shapeable guide catheter as described in embodiment 2, the shapeable guide wire being capable of being disposed within the shapeable guide catheter, the two being used in combination.
[0090] The embodiments of the present application are described above with reference to the drawings; however, the present application is not limited to the specific embodiments described above, but the specific embodiments described above are merely illustrative and not restrictive, and a person of ordinary skill in the art can make many forms under the inspiration of the present application without departing from the purpose of the present application and the scope protected by the claims, all of which belong to the protection of the present application.
Claims
1. A shapeable guide device, characterized in that, The elongated member comprises an input section disposed at a proximal end and a shaping section disposed at a distal end; The input section is configured to input electrical energy; The shaping section comprises a temperature-sensitive element and an energy conversion element, the temperature-sensitive element comprises a temperature-sensitive material with a phase transition temperature higher than human body temperature, the energy conversion element is coupled with the input section and in contact or non-contact composite with the temperature-sensitive element; When the energy conversion element receives electrical energy, the temperature of the shaping section is raised above the phase transition temperature of the temperature-sensitive element, so that the shaping section can be shaped; when the energy conversion element stops receiving electrical energy, the temperature of the shaping section is reduced below the phase transition temperature of the temperature-sensitive element, so that the shaping section maintains the shape after shaping.
2. The shapeable guide of claim 1, wherein, The input section comprises: - an electrode disposed on the outer surface of the elongated member; - a wire cavity disposed inside the elongated member; - a wire disposed in the wire cavity, the proximal end of the wire is electrically connected with the electrode, and the distal end of the wire extends to the shaping section and is electrically connected with the energy conversion element; - an insulating layer covering the outer surface of the elongated member except the electrode.
3. A shapeable guide device according to claim 2, wherein, The electrode comprises a first electrode and a second electrode, which are respectively disposed on the outer surface of the elongated member; the wire comprises a first wire and a second wire, which are respectively disposed in the wire cavity; The proximal end of the first wire is electrically connected with the first electrode, and the proximal end of the second wire is electrically connected with the second electrode; the distal end of the first wire and the distal end of the second wire both extend to the shaping section and are electrically connected with the energy conversion element, forming a closed loop.
4. The shapeable guide of claim 1, wherein, The energy conversion element comprises an electric heating wire, which extends along the length direction of the temperature-sensitive element and is disposed on the outer periphery and / or inside of the temperature-sensitive element; The electric heating wire is configured in a straight line, a spiral or a mesh.
5. The shapeable guide of claim 1, wherein, The structure of the temperature-sensitive element comprises at least one of a solid columnar structure, a hollow tubular structure or a porous structure.
6. A shapeable guide device according to claim 5, wherein, The material of the temperature-sensitive element comprises polyamide, polyformaldehyde, polyether ether ketone, polyurethane, thermoplastic polyurethane, block polyether amide, polycaprolactone or cross-linked polyethylene.
7. A shapeable guide device according to any one of claims 1-6, characterized in that The elongated member is configured as a shapeable guide wire.
8. A shapeable guide device according to claim 7, wherein, The shapeable guide wire further comprises a pushing section, which is disposed at the proximal end of the elongated member and located on the proximal end side of the input section; The pushing section comprises a metal material for transmitting a pushing force.
9. A shapeable guide device according to any one of claims 1-6, characterized in that The elongated member is configured as a shapeable catheter, which is disposed through from the proximal end to the distal end.
10. A shapeable guide device according to claim 9, wherein, The shapeable catheter further comprises a proximal handle, at least part of the input section is disposed in the proximal handle.
11. A shapeable guide system, characterized by The shapeable guide system comprises at least one shapeable guide device as claimed in any one of claims 1-10.
12. The shapeable guide system of claim 11, wherein, The shapeable guide system comprises two shapeable guide devices, which are respectively configured as a shapeable guide wire and a shapeable catheter, and the shapeable guide wire can be arranged in the shapeable catheter.