CN223653860U - A shape-adjustable guiding device and system - Google Patents

Abstract

This utility model relates to a malleable guiding device and system. The device includes an elongated component, which comprises an input section disposed at a proximal end and a shaping section disposed at a distal end. The input section is used to input electrical energy. The shaping section includes 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 to the input section and is either in contact with or in a non-contact composite with the temperature-sensitive element. When the energy conversion element receives electrical energy, the temperature of the shaping section rises above the phase transition temperature of the temperature-sensitive element, making the shaping section malleable. When the energy conversion element stops receiving electrical energy, the temperature of the shaping section drops below the phase transition temperature of the temperature-sensitive element, allowing the shaping section to maintain its shaped form.

Description

Shapable guiding device and system

Technical Field

The utility model relates to the field of medical instruments for heart surgery, in particular to a shapable guiding device and system.

Background

The interventional operation is a modern minimally invasive treatment technology, is accurately operated through image guidance, reduces trauma and risk, and is widely applied to the treatment of cardiovascular diseases, tumors and other fields. By virtue of the accuracy and safety, interventional surgery has become the first treatment mode for a plurality of diseases, and the rehabilitation speed and the life quality of patients are obviously improved. Wherein, guide wire and pipe play key role in interventional operation, and guide wire passes through apparatus such as vessel and body cavity route guide pipe, sheath pipe, sacculus, support, ensures that they reach target position accurately. The functions make the guide wire and the catheter an indispensable core tool in modern minimally invasive surgery, thereby greatly improving the success rate of the surgery and the safety of patients.

Currently, most guidewires and catheters in the market are designed in different sizes and shapes to accommodate different anatomy and surgical needs of patients. Because of the significant differences in morphology, size and pathological changes of anatomical structures such as blood vessels, digestive tracts, urinary tracts and the like in human bodies, various designs of guide wires and catheters are required to improve the trafficability, safety and operation accuracy. However, despite the numerous pre-designed sizes and shapes of guidewires and catheters, physicians often need to manually shape the guidewires/catheters, referred to as "post-shaping," as the case may be, due to the wide variety of patient anatomies. The post-shaping operation can be better adapted to the anatomical features of the individual patient, such as complex vascular travel, abnormal tissue structure or special conditions of the lesion area.

In the prior art, the post-shaping of the guide wire is usually performed by manual shaping, and the method of shaping needle shaping and high-temperature fumigation is usually performed by metal ductility and high-molecular material thermoplasticity. Both lack precise control and repeatability in the shaping process, are difficult to achieve in complex or fine shapes, and can affect the structural integrity and performance of the instrument by repeated manual shaping.

Disclosure of utility model

The utility model discloses a shapable guiding device and system, and aims to solve the technical problems in the prior art.

The utility model adopts the following technical scheme:

In one aspect, the present utility model provides a shapeable guide apparatus comprising an elongated member comprising an input section disposed at a proximal end and a shaping section disposed at a distal end;

the input section is used for inputting electric 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 the temperature of a human body, and the energy conversion element is coupled with the input section and is in contact or non-contact compounding with the temperature-sensitive element;

When the energy conversion element stops receiving the electric energy, the temperature of the shaping section is reduced to be lower than the phase transition temperature of the temperature sensitive element, so that the shaping section keeps the shaped.

As a preferred technical solution, the input section includes:

-an electrode provided on an outer surface of the elongated member;

-a guidewire lumen disposed within the interior of the elongate member;

-a lead disposed within the lead lumen, a proximal end of the lead being electrically connected to the electrode, a distal end of the lead extending to the shaping section and being electrically connected to the energy conversion element;

-an insulating layer covering the outer surface of the elongated member except the electrode.

The electrode comprises a first electrode and a second electrode which are respectively arranged on the outer surface of the slender component, wherein the lead comprises a first lead and a second lead which are respectively arranged in the lead cavity;

The proximal end of the first lead is electrically connected with the first electrode, the proximal end of the second lead is electrically connected with the second electrode, and the distal ends of the first lead and the second lead extend to the shaping section and are electrically connected with the energy conversion element to form a closed loop.

As a preferable technical scheme, the energy conversion element comprises an electric heating wire, and the electric heating wire extends along the length direction of the temperature-sensitive element and is arranged at the periphery and/or inside the temperature-sensitive element;

The heating wires are arranged in a straight line, a spiral or a mesh shape.

As a preferred technical scheme, the structure of the temperature-sensitive element comprises at least one of a solid columnar structure, a hollow tubular structure or a porous structure.

As a preferred technical scheme, the material of the temperature-sensitive element at least comprises at least one of polyamide, polyoxymethylene, polyether ether ketone, polyurethane, thermoplastic polyurethane, segmented polyether amide, polycaprolactone or crosslinked polyethylene.

As a preferred solution, the elongate member is configured as a shapeable guide wire.

As a preferred technical solution, the shapeable guide wire further comprises a pushing section, wherein the pushing section is arranged at the proximal end of the elongated member and is positioned at the proximal side of the input section;

The pushing section comprises a metallic material for transmitting the pushing force.

As a preferred solution, the elongate member is configured as a shapeable catheter, which is arranged through from the proximal end to the distal end.

As a preferred embodiment, the shapeable catheter further comprises a proximal handle, at least a partial region of the input section being disposed on the proximal handle.

In another aspect, the present utility model also provides a shapeable guide system comprising at least one shapeable guide device as defined in any one of the preceding claims.

As a preferred technical solution, the shapeable guide system comprises two shapeable guide devices, wherein the two shapeable guide devices are respectively configured as shapeable guide wires and shapeable guide tubes, and the shapeable guide wires can be arranged in the shapeable guide tubes in a penetrating way.

The technical scheme adopted by the utility model can achieve the following beneficial effects:

The utility model mainly provides a shapable guiding device and a shapable guiding system, wherein the shapable guiding device comprises an elongated member, the elongated member can be a shapable guiding wire or a guide tube, the elongated member comprises an input section arranged at a proximal end and a shaping section arranged at a distal end, the input section can input current, the shaping section realizes precise control of a shaping process through the combination of a temperature-sensitive element and an energy conversion element, the temperature-sensitive element enables the shaping section to be shaped at a specific temperature, a more complex and fine shape can be created based on a model without complex manual skills, the shape can be maintained after cooling, the shaping accuracy and repeatability are greatly improved, the elongated member can be shaped in a personalized way according to the specific condition of each patient, and the anatomical structure difference of different patients can be better adapted.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present utility model, the drawings required for the description of the embodiments are briefly described below to form a part of the present utility model, and the exemplary embodiments of the present utility model and the description thereof illustrate the present utility model and do not constitute undue limitations of the present utility model. In the drawings:

FIG. 1 is a schematic view of a shapeable guide wire according to an embodiment of the present utility model disclosed in example 1;

FIG. 2 is a schematic view of the energized state of the shapable guide wire in one embodiment of the disclosure of example 1 of the present utility model;

FIG. 3 is a schematic view of a shapeable guide wire according to one embodiment of the present disclosure in example 1;

FIG. 4 is an enlarged view of a portion of FIG. 3;

FIG. 5 is a schematic view of a shapeable guide wire according to one embodiment of the present disclosure in example 1;

FIG. 6 is an enlarged view of a portion of FIG. 5;

FIG. 7 is a schematic view of the shapeable guide wire according to the embodiment of the present utility model in example 1;

FIG. 8 is a schematic view of the shapeable guide wire according to the embodiment of the present utility model in example 1;

FIG. 9 is a schematic view of a shapable guide wire after shaping in accordance with an embodiment of the present utility model disclosed in example 1;

FIG. 10 is a schematic view of the shapeable catheter in an embodiment of the present disclosure as disclosed in example 2;

FIG. 11 is a schematic view showing the partial structure of a shapeable catheter in accordance with an embodiment of the present utility model disclosed in example 2;

fig. 12 is a schematic view showing a partial structure of a shapeable catheter in accordance with an embodiment of the present utility model disclosed in example 2.

Reference numerals illustrate:

Input section 10, wire lumen 11, wire 12, electrode 20, shaping section 30, temperature sensitive element 31, energy conversion element 32, pushing section 40, proximal handle 50, hemostatic structure 51, liquid conduit channel 52, power collet 61, and external power cord 62.

Detailed Description

In order to make the objects, technical solutions and advantages of the present utility model more apparent, the technical solutions of the present utility model will be clearly and completely described below with reference to specific embodiments of the present utility model and corresponding drawings. In the description of the present utility model, it should be noted that the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

In the description of the present utility model, it should be noted that the terms "mounted," "connected," and "connected" are to be construed broadly, unless otherwise specifically defined and limited. In addition, in the description of the present utility model, the terms "first," "second," and the like are used merely to distinguish between descriptions and are not to be construed as indicating or implying relative importance. The term "proximal" as used herein refers to the end of the shapeable guide that is closer to the operator than the end of the shapeable guide that is farther from the operator than the end of the shapeable guide. As used herein, "spiral," "mesh," "linear," "columnar," "tubular," etc., are not absolute or standard shapes, but may be generally presented in relation to shapes, etc. Those skilled in the art will appreciate that the specific shape/size/angle, etc. of each structure may be adapted to achieve the respective function while meeting the requirements of the surgical procedure.

It will be apparent that the described embodiments are only some, but not all, embodiments of the utility model. All other embodiments, which can be made by those skilled in the art based on the embodiments of the utility model without making any inventive effort, are intended to be within the scope of the utility model.

Example 1

Referring to fig. 1-9, the present embodiment provides a shapeable guide device that can be shaped at a particular angle or shape to accommodate the anatomy of a patient's blood vessel or other body passageway and guide a subsequent interventional instrument along a predetermined path to a target location.

In some embodiments, the shapeable guide device is an elongated member specifically configured as a shapeable guide wire, in this embodiment, the specification and application scenario of the shapeable guide wire are not limited, and one skilled in the art can adjust the length or diameter of the shapeable guide wire according to different target intervention positions, and can apply the shapeable guide wire to a specific blood vessel or other lumens according to different specific intervention procedures of a patient.

As shown in fig. 1, in some embodiments, the shapeable guide wire includes, in order from a proximal end to a distal end, a pushing section 40, an input section 10, and a shaping section 30, wherein the pushing section 40 is used for transmitting a pushing force, the input section 10 is used for inputting electric energy, the shaping section 30 is used for heating up and shaping into a specific shape after being electrified, and maintaining the specific shape when cooling down.

In some embodiments, the pusher section 40 comprises a metallic material to ensure effective pushing force transfer from the proximal end to the distal end of the shapeable guide wire to enable the physician to precisely control the advancement and retraction of the shapeable guide wire, and in particular, the pusher section 40 may be selected from the same metallic materials as conventional guide wires, such as medical stainless steel, platinum nickel alloy, nickel titanium alloy, cobalt chromium alloy, tungsten alloy, or the like, without limitation in this embodiment.

In some embodiments, the input section 10 comprises an electrode 20, a wire lumen 11, a wire 12 and an insulating layer, wherein the electrode 20 is exposed on the outer surface of the input section 10 and comprises a first electrode and a second electrode with opposite polarities, the wire lumen 11 is arranged inside the shapeable guiding wire and extends distally, the wire 12 is arranged in the wire lumen 11 and comprises a first wire and a second wire, the proximal end of the first wire is electrically connected with the first electrode, the proximal end of the second wire is electrically connected with the second electrode, the distal ends of the two wires 12 extend to the shaping section 30, and the insulating layer covers the outer surface of the input section 10 but does not cover the first electrode and the second electrode.

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 a proper distance to prevent short circuit, and the shape of the two electrodes can be configured based on the specification of the shapeable guide wire, and can be configured into a ring shape, a bar shape or other geometric shapes, and the shape is not particularly limited herein.

As shown in fig. 2, when the power is supplied, the power chuck 61 is clamped at the outer periphery of the input end, and two external power wires 62 of the power chuck 61 are respectively connected with the first electrode and the second electrode.

In some embodiments, the guidewire lumen 11 extends distally from the input section 10 up to the shaping section 30, which may be provided as a single lumen or divided into two separate lumens for the first and second guidewires to provide protection and guidance while maintaining the integrity of the overall structure of the shapeable guidewire.

In some embodiments, the first and second wires themselves are provided with a thin insulating coating to prevent shorting by contact with each other, and the thickness of the insulating layer outside the input section 10 needs to be thin enough to avoid affecting the overall diameter of the shapeable guide wire, but to ensure effective insulation.

In some embodiments, the wires 12 may extend straight, as shown in fig. 5 and 6, or may extend helically, as shown in fig. 3 and 4, and are not particularly limited in this embodiment

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 a human body temperature, the proximal ends of the energy conversion element 32 are respectively coupled with the distal ends of the first wire and the second wire to form a closed loop, the energy conversion element 32 is in contact with 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 is raised above the phase transition temperature of the temperature sensitive element 31 to enable the shaping section 30 to be shaped, and when the energy conversion element 32 stops receiving electric energy, the temperature of the shaping section 30 is lowered below the phase transition temperature of the temperature sensitive element 31 to enable the shaping section 30 to maintain the shaped shape.

In some embodiments, the shaping section 30 may also be composited with braided filaments or other fillers as desired for the application, and with a developer ring as desired for the function.

In some embodiments, the energy conversion element 32 is configured as a heating wire, the heating wire extends along the length direction of the temperature sensitive element 31, and may be configured as a straight line, a spiral or a net, and when the heating wires are configured in different shapes, the heat transfer effect and the mechanical performance of the heating wire are slightly different, so that a person skilled in the art can select according to the actual operation requirement, and the temperature sensitive element 31 is wrapped outside the heating wire and may be configured as a solid columnar structure, a hollow tubular structure or a porous structure. The temperature of the heating wire rises after being electrified, the molecular chain movement capability of the temperature sensitive element 31 before and after the phase transition temperature is different, and the shaping can be performed by utilizing the capability.

In some embodiments, the temperature of the heating wire can be adjusted by the magnitude of the input current so that the heating wire can be accurately increased to the phase change temperature of the temperature sensitive material, or the heating wire can be accurately calibrated in a resistance-temperature relation in advance, or the heating wire material with stable resistance-temperature coefficient can be selected, and the temperature of the heating wire can be increased to the phase change temperature of the temperature sensitive material by monitoring the resistance change of the heating wire.

In other embodiments, a temperature sensor is further disposed between the heating wire and the temperature-sensitive element 31, and the temperature of the heating wire is monitored by the temperature sensor, so that the temperature of the heating wire can rise to the phase transition temperature of the temperature-sensitive material. Specifically, the specific specification type of the temperature sensor is not specifically limited in the present embodiment, and a person skilled in the art may set according to the actual specification of the temperature sensitive element 31.

In some embodiments, the temperature sensitive material includes a crystalline polymer material and an amorphous polymer material, wherein the crystalline polymer material has a definite melting point, and at this temperature, the crystalline structure collapses, so the phase transition temperature thereof is the crystallization temperature, the amorphous polymer material has no definite melting point, the phase transition temperature thereof is the glass transition temperature, and the material is changed from a rigid glass state to a flexible rubber state, specifically, at least one of polyamide, polyoxymethylene, polyether ether ketone, polyurethane, thermoplastic polyurethane, block polyether amide, polycaprolactone or crosslinked polyethylene can be selected as the material of the temperature sensitive element 31, and different materials have different hardness, specifically, can be selected according to the usage situation.

Specifically, taking an amorphous polymer material as an example, the working principle of the temperature-sensitive element 31 is described, namely, under the action of heat, the polymer material is heated to a temperature above the glass transition temperature of the polymer material, molecular chain segments of the material can move, and under the synergistic effect of the molecular chain segments, the molecular chain segments can curl, straighten, rotate and the like, but the chain segment movement in the deformation process is reversible, and the material is in a rubbery state, so that the material can change from an initial shape to a target shape under the action of certain external force. When the force is maintained to maintain the target shape and the temperature is reduced below the glass transition temperature, the molecular segments of the material gradually freeze and become immobilized, and the material remains in the target shape. In addition, some temperature-sensitive polymer materials also have a certain shape memory effect, namely, in the state of the target shape, the temperature is raised to be higher than the glass transition temperature again, and the material can be restored to the original shape.

In some embodiments, the phase transition temperature of the temperature sensitive element 31 is set based on the actual selected material, for example, polyether ether ketone is selected to be 170-200 ℃, polyoxymethylene is selected to be 120-135 ℃, polyurethane, thermoplastic polyurethane, and block polyether amide is selected to be 60-80 ℃.

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 temperatures, the magnitude of the moduli affects the performance of the shaping section 30 in terms of retainability and supportability, and the temperature-sensitive materials also need to have certain elasticity and flexibility at room temperature and human body temperature so as to be pushed through a catheter. Therefore, materials with different moduli need to be selected according to different usage 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 property and support property at human body temperature, so that the temperature-sensitive material needs to have a higher elastic modulus at human body temperature, and when the shapeable guide wire is applied to certain coronary artery and nerve intervention surgery, the shaping section 30 needs to be flexible at human body temperature, and the temperature-sensitive material does not need to have a higher elastic modulus at the moment.

In this embodiment, the shapeable guide wire is first shaped as required before surgery, as shown in fig. 7-9, and is simultaneously connected to a power source to heat the shapeable guide wire, and when the shapeable guide wire is heated above the phase transition temperature, the operator shapes the shapeable segment 30, and then rapidly cools to below the phase transition temperature by means of water cooling, air cooling, and the like, so as to keep the shape of the shapeable segment 30.

Specifically, the shaping can be performed purely manually under the condition that the medical glove is worn in an operating room, in order to obtain a more accurate or complex structure, shaping models (such as a 3D printing model, a pipeline model and the like) can be manufactured in advance, the shaping models are brought into the operating room after disinfection is finished, and then the shapable guide wire is inserted into the shaping models, and then the operations of heating, shaping and cooling shaping are performed.

Example 2

Referring to fig. 10-12, the present embodiment provides a shapeable guide device that can be shaped to a specific angle or shape prior to surgery to accommodate the anatomy of a patient's blood vessel or other body passageway and guide a subsequent interventional instrument along a predetermined path to a target site.

In some embodiments, the shapeable guide device is an elongated member, and unlike the above embodiment 1, the elongated member is configured as a shapeable catheter, and the shapeable catheter is disposed through from the proximal end to the distal end, and the through-lumen in the middle is used to provide the instrument channel, and in this embodiment, the specification and the applicable scenario of the shapeable catheter are not specifically limited.

In some embodiments, as shown in fig. 10, 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 hemostatic structure 51, a liquid pipeline channel 52 and the like, and the main functions are hemostasis and liquid pumping, the input section 10 is used for transmitting current, the shaping section 30 is used for heating up and shaping into a specific shape after being electrified, and the specific shape is maintained when cooling down.

In some embodiments, the input section 10 includes at least a wire lumen 11 and a wire 12, and for inputting current, the proximal end of the input section 10 or the proximal handle 50 is further 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 proximal handle 50 is more integrated, reducing the risk of current leakage or short-circuiting, and enabling a physician to quickly connect or disconnect an external power source, while the input section 10 and the shaping section 30 are focused on providing a stable instrument path, while the shaping section 30 also provides shaping capabilities.

In some embodiments, the electrode 20 includes a first electrode and a second electrode configured as a positive electrode and a negative electrode, respectively, and spaced apart to avoid shorting.

In some embodiments, the input section 10 is configured as a dual-cavity structure, in which two cavities are concentrically arranged in the cross-sectional structure of the input section 10, the cavity in the middle can pass through a guide wire and other interventional instruments, the cavity in the periphery is a wire cavity 11 for arranging a wire 12, the wire 12 comprises a first wire and a second wire, the proximal end of the first wire is electrically connected with a first electrode, the proximal end of the second wire is electrically connected with a second electrode, the distal ends of the two wires 12 extend to the shaping section 30, optionally, the surfaces of the first wire and the second wire are provided with a thin insulating coating to prevent short circuit caused by mutual contact, and the outer surface of the input section 10 is further coated with an insulating layer.

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 that of a human body, the proximal ends of the energy conversion element 32 are respectively coupled with the distal ends of the first wire and the second wire to form a closed loop, the energy conversion element 32 is in contact with or non-contact with the temperature sensitive element 31, alternatively, the first wire and the second wire may be both coupled with the energy conversion element 32 at the proximal end of the shaping section 30, where both ends of the energy conversion element 32 are located at the proximal end of the shaping section 30, as shown in fig. 11, or one of the first wire and the second wire is coupled with the energy conversion element 32 at the proximal end of the shaping section 30, and the other wire extends to the distal end of the shaping section 30 and is coupled with the energy conversion element 32, as shown in fig. 12, where both ends of the energy conversion element 32 are located at the proximal end and the distal end of the shaping section 30, respectively.

When the energy conversion element 32 receives the electric energy, the temperature of the shaping section 30 is raised to be higher than the phase transition temperature of the temperature sensitive element 31, so that the shaping section 30 can be shaped, and when the energy conversion element 32 stops receiving the electric energy, the temperature of the shaping section 30 is lowered to be lower than the phase transition temperature of the temperature sensitive element 31, so that the shaping section 30 keeps the shaped shape, and reference can be made to fig. 7-9.

In some embodiments, the shaping section 30 may also be composited with braided filaments or other fillers as desired for the application, and with a developer ring as desired for the function.

In some embodiments, the shaping section 30 is also configured as a dual-cavity structure identical to the input section 10, two cavities are concentrically arranged, the cavity in the middle part can pass through a guide wire and other interventional devices, the cavity in the periphery is used for arranging the energy conversion element 32 and the temperature sensitive element 31, alternatively, the temperature sensitive element 31 can be filled in the cavity in the periphery, or the periphery cavity is made of the temperature sensitive element 31, the structure of the temperature sensitive element is hollow tubular or tubular with a porous structure, the energy conversion element 32 is configured as a heating wire, the heating wire extends along the length direction of the temperature sensitive element 31 and can be arranged in a linear shape, a double-spiral shape, a single-spiral shape or a net shape, when the heating wire is configured into different shapes, the heat transfer effect and the mechanical performance of the heating wire are slightly different, so that a person skilled in the art can select according to the actual operation requirement, the temperature of the heating wire increases after the heating wire, the difference exists in the molecular chain motion capability of the temperature sensitive element 31 before and after the phase transition temperature of the heating wire, and the shaping section 30 is shaped and shaped by utilizing the property.

In some embodiments, the material selection and the elastic modulus of the temperature-sensitive element 31 are the same as those of the embodiment 1, and will not be described herein.

In this embodiment, the shapeable catheter is first shaped before surgery, and is simultaneously connected to a power supply to heat the shapeable catheter, and when the shapeable catheter is heated to a temperature above the phase transition temperature, the shapeable catheter is shaped by a user, and then cooled down to a temperature below the phase transition temperature in a water-cooling mode, an air-cooling mode or the like, so that the shape of the shapeable catheter is maintained.

Specifically, the shaping can be performed purely manually under the condition that the medical glove is worn in an operating room, in order to obtain a more accurate or complex structure, shaping models (such as a 3D printing model, a pipeline model and the like) can be manufactured in advance, the shaped model is brought into the operating room after disinfection is finished, then a shapable catheter is inserted into the shaping model, and then the operations of heating, shaping and cooling shaping are performed.

Example 3

The present embodiment provides a shapable guiding system, which at least includes a shapable guiding device as described in embodiment 1 or embodiment 2, and the technical features already described in the foregoing embodiments are naturally inherited in the present embodiment and are not repeated.

In some embodiments, the shapeable guide system includes a shapeable guide wire as described in embodiment 1 and a conventional catheter, both used in combination.

In some embodiments, the shapeable guide system comprises a shapeable catheter as described in example 2 and a conventional guide wire, both used in combination.

In other embodiments, the shapeable guide system comprises a shapeable guide wire as described in embodiment 1 and a shapeable catheter as described in embodiment 2, the shapeable guide wire being capable of being disposed within the shapeable catheter, the shapeable guide wire being configured to cooperate therewith.

The embodiments of the present utility model have been described above with reference to the accompanying drawings, but the present utility model is not limited to the above-described embodiments, which are merely illustrative and not restrictive, and many forms may be made by those having ordinary skill in the art without departing from the spirit of the present utility model and the scope of the claims, which are to be protected by the present utility model.

Claims (12)

1. A shapeable guide apparatus comprising an elongated member including an input section disposed at a proximal end and a shaping section disposed at a distal end;

The input section is used for inputting electric 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 the temperature of a human body, and the energy conversion element is coupled with the input section and is in contact or non-contact compounding with the temperature-sensitive element;

When the energy conversion element receives electric energy, the temperature of the shaping section is increased to be higher than the phase transition temperature of the temperature sensitive element, so that the shaping section can be shaped; when the energy conversion element stops receiving the electric energy, the temperature of the shaping section is reduced to be lower than the phase transition temperature of the temperature sensitive element, so that the shaping section keeps the shaped.

2. The shapeable guide arrangement according to claim 1, wherein the input section comprises:

-an electrode disposed on an outer surface of the elongated member;

-a guidewire lumen disposed inside the elongated member;

-a lead disposed within the lead lumen, a proximal end of the lead being electrically connected to the electrode, a distal end of the lead extending to the shaping section and being electrically connected to the energy conversion element;

-an insulating layer covering the outer surface of the elongated member except the electrode.

3. The shapeable guide apparatus of claim 2, wherein the electrode includes a first electrode and a second electrode disposed on an outer surface of the elongated member, respectively, the guide wire including a first guide wire and a second guide wire disposed within the guide wire lumen, respectively;

The proximal end of the first lead is electrically connected with the first electrode, the proximal end of the second lead is electrically connected with the second electrode, and the distal ends of the first lead and the second lead extend to the shaping section and are electrically connected with the energy conversion element to form a closed loop.

4. The shapeable guide arrangement according to claim 1, characterized in that the energy conversion element comprises heating wires extending in the length direction of the temperature sensitive element and being arranged at the outer periphery and/or inside the temperature sensitive element;

The heating wires are configured in a linear, spiral or mesh shape.

5. The shapeable guide apparatus of claim 1, wherein the structure of the temperature sensitive element comprises at least one of a solid cylindrical structure, a hollow tubular structure, or a porous structure.

6. The shapeable guide arrangement according to claim 5, characterized in that the material of the temperature sensitive element comprises polyamide, polyoxymethylene, polyetheretherketone, polyurethane, thermoplastic polyurethane, block polyetheramide, polycaprolactone or cross-linked polyethylene.

7. The shapeable guide arrangement according to any one of claims 1-6, wherein the elongated member is configured as a shapeable guide wire.

8. The shapeable guide arrangement according to claim 7, wherein the shapeable guide wire further comprises a push section, the push section being disposed at a proximal end of the elongated member and being located at a proximal side of the input section;

The pushing section comprises a metallic material for transmitting a pushing force.

9. The shapeable guide arrangement according to any one of claims 1-6, characterized in that the elongated member is configured as a shapeable catheter, which shapeable catheter is arranged through from a proximal end to a distal end.

10. The shapeable guide apparatus of claim 9, wherein the shapeable catheter further includes a proximal handle, at least a partial region of the input section being disposed on the proximal handle.

11. Shapeable guide system, characterized in that it comprises at least one shapeable guide device according to any one of claims 1-10.

12. The shapeable guide system of claim 11, wherein the shapeable guide system includes two of the shapeable guide devices configured as a shapeable guide wire and a shapeable catheter, respectively, the shapeable guide wire being capable of being threaded within the shapeable catheter.