A variable support guide wire

Abstract

The present invention discloses a variable support guidewire, which comprises a connected electric control handle and a support section, wherein the support section comprises a core shaft, a nickel-titanium alloy part is arranged on the core shaft, an induction coil is sleeved on the nickel-titanium alloy part, and the nickel-titanium alloy part is switched between a martensite phase and an austenite phase by controlling the induction coil. The present invention provides a variable support guidewire, in which current is input through the electric control handle, and the current flows into the induction coil of the nickel-titanium alloy part through a wire. When the current passes through the induction coil, the nickel-titanium alloy part is heated and the nickel-titanium alloy part is switched from the martensite phase to the austenite phase, that is, the strength of the nickel-titanium alloy part is increased, thereby enhancing the support of the support section. Therefore, when a balloon or a balloon-expandable stent is used to expand the stenotic position of the lesion, the support section can more effectively support the stenotic position to enable it to be expanded.

Description

Technical Field

[0001] The invention relates to the field of medical devices, and in particular to a variable support guide wire. Background Art

[0002] Vascular intervention technology is a common minimally invasive treatment method that avoids surgical operations. Through femoral artery or radial artery puncture and intravascular catheter operation, the therapeutic device is delivered to the site of vascular lesions, which can achieve vascular recanalization in a short time. Guidewire products are essential products for vascular intervention surgery. On the one hand, they play the role of establishing a pathway so that subsequent devices such as catheters can smoothly reach the intended site of use; on the other hand, after the guidewire reaches the designated location of the vascular lesion, it should have a certain degree of support to support other devices such as balloons or balloon-expandable stents, so as to facilitate the expansion of such devices at the location of the diseased blood vessels. The support of the guidewire determines the success or failure of the operation and the length of the operation time.

[0003] The basic structure of the vascular interventional surgical guidewire currently on the market mainly includes an inner core and a spring at the head end. The proximal end of the inner core is generally a strong supporting material such as stainless steel, and the distal end is a nickel-titanium alloy superelastic material. The distal end of the inner core is ground and gradually becomes thinner, generally with 2-8 steps. The distal spring is coated with a hydrophilic coating to reduce frictional resistance or the spring is coated with a polymer material and then coated with a coating to reduce frictional resistance.

[0004] For example, the patent with the authorization announcement number CN213609286U and the authorization announcement date July 6, 2021, and its name is "A Lumen Guide Wire", this patent relates to a lumen guide wire, including an inner core and a first spring, the inner core is divided into a trunk section and a guide section, the trunk section is made of stainless steel, and the guide section is made of nickel-titanium alloy; one end of the trunk section is fixedly connected to one end of the guide section; the first spring is sleeved on the outer surface of the connection between the trunk section and the guide section, the first spring is divided into a first section and a second section, the end of the first section is fixed on the trunk section, and the end of the second section is fixed on the guide section, thereby effectively solving the problem of poor elasticity and recoverability of lumen guide wires in the prior art.

[0005] The shortcomings of the above-mentioned patents are that the material characteristics of the nickel-titanium wire at the distal end of the guidewire are relatively soft, resulting in weak support. When a balloon or a balloon-expandable stent is used to expand the narrow position of the lesion, the balloon or balloon-expandable stent will shift proximally due to gravity due to the weak support force of the guidewire. In this way, the operator must continue to push the guidewire to farther and thinner blood vessel branches, using the thicker part of the core wire to provide support (because the distal end is multi-step diameter change). As the guidewire continues to be pushed, the blood vessel will become thinner and thinner, and the branches will increase. The cerebral blood vessel wall itself is relatively thin and easily perforated, causing hemorrhagic stroke or prolonging rescue time. Summary of the invention

[0006] The object of the present invention is to provide a variable support guide wire to solve the above-mentioned deficiencies in the prior art.

[0007] In order to achieve the above object, the present invention provides the following technical solutions:

[0008] A variable support guidewire comprises a connected electric control handle and a support section, wherein the support section comprises a core shaft, a nickel-titanium alloy part is arranged on the core shaft, an induction coil is sleeved on the nickel-titanium alloy part, and the nickel-titanium alloy part is switched between a martensite phase and an austenite phase by control of the induction coil.

[0009] The above-mentioned variable support guidewire, the support section also includes a sheath sleeved on the core shaft, and the induction coil is located inside the sheath.

[0010] The above-mentioned variable support guidewire has an axial channel arranged in the support section, a cooling space is formed between the sheath and the core shaft, and a cooling water injection device is also arranged on the electric control handle, and the cooling water injection device injects water into the cooling space through the axial channel to realize cooling of the nickel-titanium alloy part.

[0011] In the above-mentioned variable support guidewire, the axial channel includes a water inlet channel and a water outlet channel.

[0012] The variable support guide wire mentioned above closes the water outlet channel so that the cooling space is filled with cooling water to enhance the strength of the support section.

[0013] In the above-mentioned variable support guide wire, a developing spring is arranged at the distal end of the core shaft.

[0014] The variable support guide wire mentioned above, the material of the developing spring is platinum-tungsten alloy or platinum-nickel alloy.

[0015] In the above-mentioned variable support guidewire, a curved portion is arranged on the distal end of the core shaft, and in a natural state, the curved portion is in a curved state.

[0016] In the above-mentioned variable support guidewire, a bending adjustment member is sleeved on the distal end of the core shaft, and the bending adjustment member is used to adjust the curvature of the bending portion.

[0017] In the above-mentioned variable support guide wire, a plurality of annular protrusions are arranged on the bending portion, and a plurality of annular grooves are arranged on the bending adjustment member, and the plurality of annular protrusions correspond to the plurality of annular grooves one by one.

[0018] In the above technical scheme, the present invention provides a variable support guidewire, in which current is input through an electric control handle, and the current flows into the induction coil of the nickel-titanium alloy part through the wire. When the current passes through the induction coil, the nickel-titanium alloy part is heated and the temperature rises. At this time, the nickel-titanium alloy part switches from the martensite phase to the austenite phase, that is, the strength of the nickel-titanium alloy part is increased, thereby enhancing the support of the support segment. Therefore, when the stenosis of the lesion is expanded by a balloon or a balloon-expandable stent, the support segment can more effectively support the stenosis to enable it to be expanded. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the present invention. For ordinary technicians in this field, other drawings can also be obtained based on these drawings.

[0020] Figure 1 A schematic diagram of the structure of a guidewire provided by an embodiment of the present invention in a blood vessel;

[0021] Figure 2 A distal cross-sectional view of a guide wire provided by an embodiment of the present invention;

[0022] Figure 3 A distal cross-sectional view of a guide wire provided in yet another embodiment of the present invention;

[0023] Figure 4 A distal cross-sectional view of a guide wire provided in yet another embodiment of the present invention;

[0024] Figure 5 A distal cross-sectional view of a guide wire provided in yet another embodiment of the present invention.

[0025] Description of reference numerals:

[0026] 1. Electric control handle; 2. Cooling water injection device; 3. Axial channel; 4. Proximal mandrel; 5. Nickel-titanium mandrel; 6. Sheath; 7. Support section; 8. Induction coil; 9. Bending part; 10. Bending adjustment part; 11. Annular protrusion; 12. Annular groove. DETAILED DESCRIPTION

[0027] In order to enable those skilled in the art to better understand the technical solution of the present invention, the present invention will be further described in detail below with reference to the accompanying drawings.

[0028] In each embodiment of the present invention, "proximal end" and "distal end" refer to the relative orientation, relative position, and direction of components or actions relative to each other from the perspective of a doctor using the medical device. Although "proximal end" and "distal end" are not power-restrictive, "proximal end" generally refers to the end of the medical device that is close to the doctor during normal operation, and "distal end" generally refers to the end that is away from the doctor and first enters the patient's body.

[0029] Reference Figure 1-5 An embodiment of the present invention provides a variable support guidewire, which includes a connected electric control handle 1 and a support segment 7, wherein the support segment 7 includes a core shaft, a nickel-titanium alloy part is provided on the core shaft, and an induction coil 8 is sleeved on the nickel-titanium alloy part. The nickel-titanium alloy part is switched between the martensite phase and the austenite phase by controlling the induction coil 8.

[0030] Specifically, the electric control handle 1 is located at the proximal end of the guide wire, and the support section 7 is located at the distal end of the guide wire. The electric control handle 1 is used to control the variable support guide wire, including controlling the electric control handle 1 to realize whether the induction coil 8 is energized or not. The electric control handle 1 is a prior art and will not be described in detail. The support section 7 includes a core shaft, and the core shaft includes a proximal core shaft 4 and a nickel-titanium core shaft 5. The nickel-titanium core shaft 5 is located at the distal end of the proximal core shaft 4. The distal end of the nickel-titanium core shaft 5 is ground and reduced in diameter to gradually become thinner. Preferably, the proximal core shaft 4 is made of stainless steel or cobalt-chromium alloy, and the nickel-titanium core shaft 5 is a nickel-titanium alloy part. The material of the nickel-titanium alloy part is nickel-titanium alloy. The nickel-titanium alloy has two stable forms, namely, martensite phase and austenite phase. At low temperature, the nickel-titanium alloy is in the martensite phase. At this time, the nickel-titanium alloy has higher elasticity and memory, but lower strength at this time. At high temperature, the nickel-titanium alloy wire is transformed into an austenite phase. At this time, the nickel-titanium alloy has high strength. This is a prior art and will not be described in detail. The nickel-titanium alloy part is provided with an induction coil 8, which is sleeved on the nickel-titanium alloy part. When the electric control handle 1 inputs current to the nickel-titanium alloy part of the support section 7, the nickel-titanium alloy part is in a high-frequency alternating electric field and generates an induced electromotive force inside. Due to its small resistance, a strong induced current, i.e., eddy current, will be generated. These eddy currents will cause Joule heating, causing the nickel-titanium alloy part to heat up rapidly. During the induction heating process, the current tends to flow on the surface of the nickel-titanium alloy part. As the current frequency increases, the eddy current density is more concentrated on the surface, resulting in an increase in resistance, and then the temperature rises faster to achieve the phase change of the nickel-titanium alloy part. In this way, when the guide wire reaches the predetermined position, the electric control handle 1 inputs current to the induction coil 8, and the induction coil 8 heats up, causing the temperature of the nickel-titanium alloy part to rise. At this time, the nickel-titanium alloy part is transformed from the martensite phase to the austenite phase. When the nickel-titanium alloy part is in the austenite phase, the strength of the support section 7 is relatively high, thereby providing support. Cooling can be performed naturally or by other methods such as water cooling and air cooling.

[0031] A variable support guidewire provided by an embodiment of the present invention inputs current through an electric control handle 1, and the current flows into the induction coil 8 of the nickel-titanium alloy part through the wire. When the current passes through the induction coil 8, the nickel-titanium alloy part is heated and the temperature of the nickel-titanium alloy part is increased. At this time, the strength of the nickel-titanium alloy part is increased, thereby enhancing the support of the support segment 7. Therefore, when a balloon or a balloon-expandable stent is used to expand the stenotic position of the lesion, the support segment 7 can more effectively support the stenotic position to enable it to be expanded.

[0032] In another embodiment provided by the present invention, the support section 7 also includes a sheath 6 sleeved on the core shaft, one end of the sheath 6 is open to be sealed and connected to the thicker end of the nickel-titanium core shaft 5 connected to the proximal core shaft 4, the other end of the sheath 6 is closed and the inner wall is in contact with the distal end of the nickel-titanium core shaft 5, that is, an accommodation space is formed between the sheath 6 and the core shaft, the induction coil 8 is located in the accommodation space inside the sheath 6, a cooling water injection device 2 is also provided on the electric control handle 1, an axial channel 3 is provided in the support section 7, and at this time the accommodation space is a cooling space, the axial channel 3 includes a water inlet channel and a water outlet channel, one end of the water inlet channel is connected to the cooling water injection device 2, the other end of the water inlet channel is connected to the cooling space, and one end of the water outlet channel is connected to the cooling water injection device 2, The other end of the water outlet channel is connected to the cooling space, and the cooling water injection device 2 injects water into the cooling space through the axial channel 3 to cool the nickel-titanium alloy part, that is, the cooling water injection device 2 injects cooling water into the water inlet channel, and the cooling water enters the cooling space to cool the nickel-titanium alloy part. The cooling water injected by the cooling water injection device 2 has a certain pressure, so that the cooling water can flow out from the water outlet channel. In this way, when the operation is completed, the input of current is stopped, and the cooling water injection device 2 can be used to cool the support segment 7 quickly. At this time, the nickel-titanium alloy part is transformed from the austenite phase to the martensite phase. In this way, the cooling water injection device 2 is set so that the nickel-titanium alloy part can be quickly cooled after heating, so that when the nickel-titanium alloy part is transformed from the austenite phase to the martensite phase, the strength of the support segment 7 becomes low, which is conducive to the withdrawal of the guide wire from the body.

[0033] Furthermore, the present embodiment can also obtain a hardness for the support segment 7 that is between the transformation of the austenite phase and the martensite phase for surgical selection. This is an intermediate hardness state. At this time, the induction coil 8 makes the nickel-titanium alloy part a martensite phase. At the same time, when the cooling water injection device 2 injects cooling water into the cooling space, the water outlet channel is closed. At this time, the cooling space will be filled with cooling water. By filling the accommodating space with cooling water, the strength of the support segment 7 is improved and maintained. A developing spring is provided at the distal end of the core shaft. Preferably, the developing spring is made of platinum-tungsten alloy or platinum-nickel alloy, which has good elasticity, can buffer the impact on the blood vessels and play a developing role, and is convenient for the operator to observe.

[0034] In another embodiment provided by the present invention, Figure 3 As shown, a curved portion 9 is provided on the distal end of the core shaft. Preferably, the curved portion 9 is made of elastic material. One end of the curved portion 9 is connected to the distal end of the core shaft. In a natural state, the curved portion 9 is in a curved state. At the same time, a cylindrical curved adjustment member 10 is sleeved on the curved portion 9. The curved adjustment member 10 is located at the proximal end of the curved portion 9. The sleeve limit of the curved adjustment member 10 forces the curved portion 9 to be in a straight state, that is, the curved portion 9 has a curved shape in a natural state and a straight shape after being sleeved. During the advancement of the guide wire in the blood vessel, due to the thin blood vessel wall, the curved curved portion 9 is curved due to the bending. The degree of curvature is large and its distal end is likely to puncture the blood vessel wall. Therefore, a bending adjustment member 10 is sleeved on the distal end of the core shaft. The proximal end of the cylindrical bending adjustment member 10 is also provided with a raised ring to facilitate the push of cooling water. At the same time, an elastic reset member such as a spring (prior art, not shown in the figure) is provided in the cooling space. One end of the elastic reset member is connected to the inner wall of the sheath 6, and the other end of the elastic reset member is connected to the ring. The bending adjustment member 10 is separated from the curved portion 9 to be in a natural state by the pulling force of the elastic reset member. When encountering a straight blood vessel, through the above-mentioned intermediate hardness state, that is, when the cooling water injection device 2 is injected into the cooling water injection device 2, the cooling water injection device 2 is injected into the cooling water injection device 2. When cooling water is injected into the cooling space, the water outlet channel is closed, and the pressure of the cooling water is used to push the ring of the bending adjustment member 10 to force it to be sleeved on the upper bending portion. Then the bending portion 9 is in a straight line state, that is, the bending adjustment member 10 is sleeved on the bending portion 9 to achieve the advancement of the straight blood vessel. The corresponding hardness at this time is also convenient for advancing in the straight blood vessel. When encountering a curved blood vessel, by releasing cooling water, the bending adjustment member 10 is separated from the curved portion 9 under the action of the elastic reset member. At this time, the curved portion 9 is in a curved state, and the hardness is also small, which is convenient for advancing in the curved blood vessel. When encountering a straight blood vessel, cooling water is injected into the cooling space. The thrust generated by the cooling water pushes the bending adjustment member 10 to move along the distal direction of the core shaft, and makes the bending adjustment member 10 completely sleeved on the curved portion 9. At this time, the curved portion 9 is in a straight state. When encountering a curved blood vessel, the cooling water exits the bending adjustment member 10 to make it move toward the proximal end along the core shaft under the action of the elastic reset member, and makes the bending adjustment member 10 completely separate from the curved portion 9. In this way, the curved portion 9 will be in a natural curved shape so as to pass through the curved blood vessel. The purpose of setting the curved portion 9 and the bending adjustment member 10 in this way is to make the guide wire pass quickly in the blood vessel and reduce the risk of rupture of the blood vessel wall. In this embodiment, a hole needs to be opened on the sheath corresponding to the curved portion 9 to adapt to the changes in the internal space caused by the reciprocating motion of the bending adjustment member 10.

[0035] In another embodiment provided by the present invention, Figure 5As shown, the bending portion 9 is provided with a plurality of annular protrusions 11, and the annular protrusions 11 include a proximal annular protrusion and a distal annular protrusion. The bending adjusting member 10 is provided with a plurality of annular grooves 12. Preferably, the annular grooves 12 include a proximal annular groove and a distal annular groove. The proximal annular protrusions correspond to the distal annular grooves one by one, and the distal annular protrusions correspond to the proximal annular grooves one by one. Preferably, the annular protrusions 11 and the annular grooves 12 are both made of elastic materials, so that when the bending adjusting member 10 slides toward the distal end of the core shaft, The proximal annular protrusion will be located in the distal annular groove, so that one section of the curved portion 9 is in a straight state and the other section is in a curved state. At this time, the curvature of the curved portion 9 becomes smaller. When the cooling water pressure is too large, the proximal annular protrusion will be separated from the distal annular groove, so that the bending adjustment member 10 continues to move toward the distal end. When the distal annular protrusion is located in the proximal annular groove, the straight length of the curved portion 9 will be greater than the length of the curved portion 9. At this time, the curvature continues to decrease. In this way, the curvature of the curved portion 9 can be fine-tuned by setting the annular protrusion and the annular groove.

[0036] In the above embodiment of the present invention, a valve-like structure can be set to close the water outlet channel, and the bending adjustment member 10 can be pushed to different positions so that the water pump of the cooling water injection device 2 can be a variable frequency water pump. In this way, different driving pressures can be obtained to drive the bending adjustment member 10 to different positions. The above are all existing technologies and will not be repeated.

[0037] The above description is only by way of illustration of certain exemplary embodiments of the present invention. It is undoubted that those skilled in the art can modify the described embodiments in various ways without departing from the spirit and scope of the present invention. Therefore, the above drawings and descriptions are illustrative in nature and should not be construed as limiting the scope of protection of the claims of the present invention.

Claims

1. A variable support guidewire, comprising a connected electric control handle and a support segment, characterized in that: The support section includes a core shaft, a nickel-titanium alloy part is arranged on the core shaft, an induction coil is sleeved on the nickel-titanium alloy part, and the nickel-titanium alloy part is switched between the martensite phase and the austenite phase by the control of the induction coil. A bending part is arranged on the distal end of the core shaft, and the bending part is in a bent state in a natural state. A bending adjustment piece is sleeved on the distal end of the core shaft, and the bending adjustment piece is used to adjust the curvature of the bending part. A plurality of annular protrusions are arranged on the bending part, and a plurality of annular grooves are arranged on the bending adjustment piece, and the plurality of annular protrusions and the plurality of annular grooves correspond to each other one by one.

2. The variable support guidewire according to claim 1, characterized in that: The support section also includes a sheath sleeved on the core shaft, and the induction coil is located inside the sheath.

3. The variable support guidewire according to claim 2, characterized in that: An axial channel is provided in the support section, a cooling space is formed between the sleeve and the core shaft, and a cooling water injection device is also provided on the electric control handle. The cooling water injection device injects water into the cooling space through the axial channel to cool the nickel-titanium alloy part.

4. The variable support guidewire according to claim 3, characterized in that: The axial channel includes a water inlet channel and a water outlet channel.

5. The variable support guidewire according to claim 4, characterized in that: The water outlet channel is closed so that the cooling space is filled with cooling water to improve the strength of the supporting section.

6. The variable support guidewire according to claim 1, characterized in that: A developing spring is arranged at the distal end of the core shaft.

7. The variable support guidewire according to claim 6, characterized in that: The material of the developing spring is platinum-tungsten alloy or platinum-nickel alloy.

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