A guide wire assisting device for a bifurcated lesion and a medical device having the same

Abstract

The present invention discloses a guidewire assist device for bifurcation lesions and a medical device having the same, wherein the guidewire assist device comprises a device body and a push rod, wherein the device body comprises a main branch guidewire guide portion and a branch guidewire clamping portion, and the guidewire assist device uses the main branch guidewire as a guide to pass through the central cavity of the main branch stent into the main branch blood vessel and release the branch guidewire. The guidewire assist device disclosed in the present invention and the medical device having the same have the following advantages: ① the branch guidewire can be safely and quickly positioned at the branch opening; ② the risk of entanglement between the branch guidewire and the main branch guidewire is effectively avoided; ③ the risk of the branch guidewire perforating the blood vessel wall during transportation is avoided; ④ the risk of a small branch guidewire entering the gap between the outer side of the main branch stent and the blood vessel wall is avoided; ⑤ the end bouncing of the branch guidewire is eliminated by the setting of the accommodating cavity; ⑥ the passing performance of the branch guidewire through the central cavity of the stent is ensured.

Description

Technical Field

[0001] The present invention relates to the field of medical technology, and in particular to a guidewire-assisted device for treating bifurcation lesions of a biological vessel and a medical device having the same. Background Art

[0002] The body, especially the human body, contains numerous branching ducts, including those in the blood vessels, respiratory tract, digestive tract, ear canal, and nasal cavity. However, due to their unique air and fluid flow characteristics, these branches are prone to various types of obstruction and infection. Interventional therapies using guidewire-mediated stents, balloons, and drug delivery are currently a rapidly developing treatment approach.

[0003] Coronary artery bifurcation lesions, representing approximately 20-30% of coronary interventional treatments, are a common clinical problem and one of the most challenging lesions to treat. Treatment of coronary artery bifurcation lesions is difficult and time-consuming, requiring a high level of surgical skill, and carries a high complication rate. Severe branch occlusion can be life-threatening.

[0004] During endovascular interventional therapy, after entering the vascular lumen, the guidewire must navigate through intravascular channels, branches, and winding sections, sometimes even breaking through stenosis to reach the target site, thereby guiding other interventional medical devices such as catheters and microcatheters to the corresponding site or area. Therefore, in endovascular interventional procedures, especially in the treatment of lesions such as coronary arteries, intracranial arteries, vascular malformations, and small blood vessels within tumors, the performance of the guidewire has a crucial impact on the treatment outcome.

[0005] During endovascular interventional therapy, after entering the vascular lumen, the guidewire must pass through intravascular channels, branches, and winding sections, sometimes even breaking through stenosis to reach the target site, thereby guiding other interventional medical devices such as catheters and microcatheters to the corresponding site or area. Therefore, in endovascular interventional procedures, especially in the treatment of lesions such as coronary arteries, small intracranial arteries, vascular malformations, and small blood vessels within tumors, the performance of the guidewire has a crucial impact on the treatment outcome.

[0006] Currently, the most difficult step in stent placement surgery for bifurcation lesions is: after the main branch stent is released, the branch guidewire must reach the opening of the branch vessel from the central cavity of the proximal main branch stent, and then cross the appropriate stent mesh to enter the branch vessel, thereby protecting the branch vessel and further. This step is called rewire guidewire. Studies have shown that the use of POT (proximal stent optimization technology)-side branch expansion-rePOT technology in bifurcation lesion stent surgery can effectively shorten the operation time, intraoperative exposure time and reduce the amount of contrast agent used. Therefore, in recent years, POT (proximal stent optimization technology)-side branch expansion-rePOT has gradually become a routine process in single stent surgery (such as Figure 12 As shown in the figure, the prerequisite for side branch expansion is to rewire the guidewire. Under current conditions, this step requires extremely high technical skills and equipment of the surgeon, is time-consuming, and inefficient. It is difficult to ensure that the branch guidewire can smoothly enter the branch lesion through the correct pathway, and it is easy to cause the branch guidewire to be entangled with the main branch guidewire. If the branch guidewire enters the branch vessel through the outside of the main branch stent, it will bring catastrophic consequences, leading to surgical failure and endangering the patient's life.

[0007] Therefore, the auxiliary device of the present invention can ensure that the branch guidewire can efficiently and quickly reach the predetermined position through the central cavity of the main branch stent, which is of great positive significance. Summary of the Invention

[0008] The problem solved by the present invention is that the branch guidewire is slow to intervene and is easily entangled with the main branch guidewire during delivery, or the branch guidewire enters the gap between the outside of the main branch stent and the blood vessel wall, resulting in surgical failure.

[0009] The present invention provides a guidewire-assisted device for bifurcation lesions, which uses the main branch guidewire as a guide rail, and can quickly send the branch guidewire through the central cavity of the main branch stent into the main branch blood vessel, and then release the branch guidewire. The operator pulls the branch guidewire back to quickly position the branch guidewire at the branch opening. The device places the main branch guidewire and the branch guidewire separately, which can effectively prevent the risk of the branch guidewire being entangled with the main branch guidewire during delivery. At the same time, due to the clamping of the branch guidewire by the guidewire-assisted device, the risk of the branch guidewire perforating the blood vessel wall during delivery is avoided, and the branch guidewire can be quickly delivered. At the same time, the setting of the guidewire-assisted device avoids the risk of a small guidewire entering the gap between the outside of the main branch stent and the blood vessel wall, effectively improving the safety and success rate of the operation.

[0010] The object of the present invention is to provide a guidewire auxiliary device for bifurcation lesions, the guidewire auxiliary device comprising a device body and a pushing rod, the proximal end of the pushing rod is fixedly connected to the device body, the distal end of the pushing rod is a hand-held part, the device body comprises a main branch guidewire guide part and a branch guidewire clamping part, the main branch guidewire guide part is provided with a main branch guidewire hole, the main branch guidewire passes through the main branch guidewire hole, the branch guidewire clamping part is provided with a branch guidewire cavity, the branch guidewire cavity is used to clamp and fix the branch guidewire.

[0011] Furthermore, the guidewire auxiliary device uses the main branch guidewire as a guide rail to enter the main branch blood vessel through the central cavity of the main branch stent and separate from the branch guidewire.

[0012] The proximal end described in the present invention is the end closer to the heart when the device is in use, and the distal end is the end farther away from the heart when the device is in use. The guidewire-assisted device is transported into the blood vessel. Since the main branch guidewire is used as a guide rail, the guidewire-assisted device does not have the risk of entering the gap between the outside of the main branch stent and the blood vessel wall. At the same time, since the main branch guidewire and the branch guidewire are separated and supported by two different cavities, there is no risk of the two being entangled with each other during transportation. The guidewire-assisted device can be quickly delivered into the central cavity of the main branch stent. Then, after the guidewire-assisted device enters the main branch blood vessel, the branch guidewire is fixed, and the branch guidewire is separated from the guidewire-assisted device by pushing the distal end of the push rod. Then, the branch guidewire is pulled back to reach the opening of the branch blood vessel, avoiding the slow delivery speed of the branch guidewire and the risk of entering the gap between the outside of the main branch stent and the blood vessel wall, and also avoiding the risk of the branch guidewire being entangled with the main branch guidewire.

[0013] Furthermore, the branch guidewire cavity includes a clamping portion, which is arranged close to the proximal end and is used to clamp the branch guidewire.

[0014] This arrangement can ensure that the branch guide wire is not easily dropped during transportation, and after reaching a predetermined position, the branch guide wire is fixed, and then the distal end of the push rod is gently pushed to release the branch guide wire.

[0015] Furthermore, the length of the clamping portion is 0.1-4 cm. Preferably, the length of the clamping portion 4111 is 0.1-1 cm. More preferably, the length of the clamping portion 4111 is 0.1-0.4 cm. Even more preferably, the length of the clamping portion 4111 is 0.1-0.2 cm.

[0016] This arrangement can reduce the stress accumulation between the branch guide wire and the clamping portion when the distal end of the push rod is pushed, and reduces the risk of stress release at the end of the branch guide wire when it is separated, thereby causing irregular bouncing and damaging the blood vessel wall.

[0017] Furthermore, the branch guidewire cavity further includes a transition portion and a receiving portion, the receiving portion is smoothly connected to the clamping portion through the transition portion, and the receiving portion is used for inserting or withdrawing the branch guidewire.

[0018] The accommodating portion is used to accommodate the portion behind the head of the branch guidewire. Since the clamping portion is short, the accommodating portion can prevent the branch guidewire from bending around the clamping portion. At the same time, when setting the branch guidewire, the branch guidewire can be controlled at both ends of the branch guidewire clamping portion, and placed from the top to the bottom of the branch guidewire accommodating cavity. At the same time, the head end of the branch guidewire is clamped in the clamping portion. When the branch guidewire is separated from the clamping portion, the accommodating portion can limit its elastic movement at the moment of separation, thereby avoiding damage to the vascular wall of the main branch blood vessel. At the same time, the smooth connection between the clamping portion and the accommodating portion can prevent damage to the branch guidewire by edges, further avoiding damage to the human blood vessel wall by the damaged branch guidewire.

[0019] Furthermore, after the branch guidewire is separated from the guidewire auxiliary device, the head end of the branch guidewire is separated from the tail end of the accommodating portion.

[0020] That is, the top of the accommodating portion is narrowed or sealed to restrict the branch guide wire from passing through the top of the accommodating portion, which can further prevent and eliminate the bounce of the branch guide wire when it leaves the clamping portion, thereby further protecting the blood vessel wall.

[0021] Furthermore, the top of the accommodating portion is closed, or the accommodating portion extends to open at its top. Preferably, when the accommodating portion extends to open at its top, the width of the top opening of the accommodating portion is smaller than the diameter of the branch guide wire. More preferably, the width of the top opening of the accommodating portion is equal to the width of the clamping portion.

[0022] The limitation on the opening width of the accommodating portion can effectively limit the elastic range of the branch guide wire during separation, which is beneficial to protecting the blood vessel wall from damage.

[0023] Furthermore, the clamping portion is made of a shape memory alloy, and the width of the clamping portion remains in a reduced state at low or normal temperatures, and recovers the memory shape within the human body temperature range.

[0024] The clamping part is made of shape memory alloy, so that the width of the clamping part can be much smaller than the diameter of the branch guide wire at low temperature or room temperature, so that the branch guide wire is less likely to fall off during the delivery of the guide wire auxiliary device. When the branch guide wire reaches the predetermined position, it is heated by the human body temperature, and the width of the clamping part is expanded after heating. The branch guide wire automatically detaches from the guide wire auxiliary device or is lightly clamped. The branch guide wire can be detached from the guide wire auxiliary device by lightly pushing the distal end of the push rod to complete the delivery.

[0025] Furthermore, when the recovery time of the shape memory alloy within the human body temperature range is more than 30 seconds, the ratio of the width of the clamping portion after restoring the memory shape to the diameter of the branch guide wire is greater than 0.995; when the recovery time of the shape memory alloy within the human body temperature range is less than 30 seconds, the ratio of the width of the clamping portion after restoring the memory shape to the diameter of the branch guide wire is between 0.985-0.995.

[0026] For the sake of convenience, the width of the clamping part made of shape memory alloy after recovery is referred to as the preset width, and the recovery time of the shape memory alloy within the human body temperature range is referred to as the recovery time. When using the guidewire assisting device provided by the present invention to deliver a branch guidewire, the operator can deliver the guidewire assisting device to the predetermined position in about 30 seconds. Therefore, the preset width needs to be set according to the recovery time. If the recovery time is less than 30 seconds, the preset width needs to be relatively small to prevent the branch guidewire from automatically falling off during delivery. At the same time, after it reaches the predetermined position, the distal end of the push rod can be gently pushed to complete the separation of the branch guidewire from the guidewire assisting device. If the recovery time is more than 30 seconds, the preset width can be appropriately relaxed. If the operator is proficient in operation, the preset width can be set larger than the diameter of the branch guidewire. In this case, when the operator delivers the guidewire assisting device to the predetermined position, within the human body temperature range, the shape memory metal recovers the preset width, and the branch guidewire can be automatically separated from the guidewire assisting device. In this case, stress concentration during pushing by the push rod can be avoided, and the optimal state of no bounce when the branch guidewire is separated from the guidewire assisting device can be achieved.

[0027] Furthermore, the head end and tail end of the branch guidewire clamping portion are both streamlined, the head end and tail end of the main branch guidewire guiding portion are both streamlined, and the guidewire auxiliary device is entirely coated with a super-slip coating or a hydrophilic coating.

[0028] The head end described in the present invention is the proximal end of the guidewire-assisted device, and the tail end is the distal end of the guidewire-assisted device. Since the operation is usually performed in the arterial blood vessels, special attention needs to be paid to the protection of the blood vessel wall. The above-mentioned streamlined setting can prevent the edges or head of the guidewire-assisted device from touching the blood vessel wall during transportation to cause unnecessary damage, thereby improving the safety of the operation. At the same time, the use of super-slip coating or hydrophilic coating can change the surface friction coefficient of the guidewire-assisted device, which can usually be reduced by more than 98%, thereby forming a lubricated surface. This lubricated surface can reduce the intervention force of the guidewire-assisted device and can pass through the blood vessels more easily, avoiding possible puncture or friction damage.

[0029] Furthermore, the device body, the pushing rod and the branch guide wire clamping portion are made of the same material, or the device body, the pushing rod and the branch guide wire clamping portion are made of different materials.

[0030] Using the same or different materials can meet the actual needs of different patients, so as to deal with various diseases more specifically.

[0031] Furthermore, the device body, the push rod and the branch guide wire clamping part are all made of metal, or the device body, the push rod and the branch guide wire clamping part are all made of non-metallic materials, or at least one of the device body, the push rod and the branch guide wire clamping part is made of metal and at least one is made of non-metallic material.

[0032] This setting can meet the usage requirements in multiple scenarios.

[0033] The present invention also provides a medical device, which includes the above-mentioned guidewire auxiliary device.

[0034] The effects of this medical device are the same as those of the above-mentioned guidewire auxiliary device, and will not be described in detail here.

[0035] The specific beneficial effects of the present invention include:

[0036] 1. Using the main branch guidewire as a guide rail, the branch guidewire can be quickly delivered through the central lumen of the main branch stent into the main branch vessel. The branch guidewire is then released and the surgeon pulls it back to quickly position it at the branch opening, greatly shortening the time it takes to deliver the branch guidewire to the branch opening and shortening the surgical time.

[0037] 2. The main guide wire and the branch guide wire are set separately, which effectively avoids the risk of entanglement between the branch guide wire and the main guide wire and improves the success rate of the operation;

[0038] 3. The guidewire assist device holds the branch guidewire, avoiding the risk of the branch guidewire perforating the blood vessel wall during delivery, ensuring rapid delivery of the branch guidewire while also ensuring patient safety.

[0039] 4. The setting of the guidewire-assisted device avoids the risk of small branch guidewires entering the gap between the outside of the main branch stent and the blood vessel wall, effectively improving the safety and success rate of the operation.

[0040] 5. The setting of the accommodating channel controls the bounce of the branch guidewire end when it separates from the guidewire assist device, further reducing the risk of the branch guidewire piercing the blood vessel wall;

[0041] 6. The clamping part is made of shape memory alloy, which can fully utilize its ability to restore the memory shape within the human body temperature range. In particular, when the recovery time of the shape memory alloy is more than 30 seconds, the width of the clamping part after restoring the memory shape can be larger than the diameter of the branch guidewire, realizing the automatic release of the branch guidewire without the end bouncing, which has higher safety.

[0042] 7. Since the branch guidewire is in the guidewire auxiliary device, the guidewire auxiliary device is first transported to a predetermined position and then the branch guidewire is released to ensure the passing performance of the branch guidewire through the central lumen of the stent. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings of the embodiments of the present invention are briefly introduced below.

[0044] The accompanying drawings are only used to illustrate some embodiments of the present invention, rather than to limit all embodiments of the present invention thereto.

[0045] Attachment Figure 1 : A schematic diagram of the three-dimensional structure of the guidewire assist device according to an embodiment of the present invention in a non-working state;

[0046] Attachment Figure 2 : A schematic diagram of the three-dimensional structure of the guidewire assist device according to an embodiment of the present invention in a non-working state from another perspective;

[0047] Attachment Figure 3 : A left side view of the guidewire assist device according to an embodiment of the present invention in a non-operating state;

[0048] Attachment Figure 4 : Attached Figure 3 Middle AA section;

[0049] Attachment Figure 5 : Attached Figure 4 Enlarged view of middle part B;

[0050] Attachment Figure 6 : A schematic diagram of the three-dimensional structure of the guidewire assist device in working state according to an embodiment of the present invention;

[0051] Attachment Figure 7 : A front view of the guidewire assist device according to an embodiment of the present invention in working state;

[0052] Attachment Figure 8 : Attached Figure 7 Mid-CC section;

[0053] Attachment Figure 9 : Attached Figure 7 Enlarged view of the middle D part;

[0054] Attachment Figure 10 : A front view of the guidewire-assisted device in working state, wherein the device body and the push rod of Example 2 of the present invention gradually become thicker from the distal end to the proximal end;

[0055] Attachment Figure 11 : A schematic diagram of the three-dimensional structure of a guidewire assist device in working state according to another embodiment of the present invention;

[0056] Attachment Figure 12 : Schematic diagram of POT+branch dilation+rePOT during single-stent surgery.

[0057] Description of reference numerals:

[0058] 1. Main branch guidewire; 2. Branch guidewire; 21. X-ray positioning mark; 3. Push rod; 31. Proximal end of push rod; 32. Distal end of push rod; 4. Device body; 41. Branch guidewire clamping part; 411. Branch guidewire cavity; 4111. Clamping part; 4112. Transition part; 4113. Accommodating part; 42. Main branch guidewire guiding part; 421. Main branch guidewire hole. DETAILED DESCRIPTION

[0059] In order to make the purpose, technical solution and advantages of the technical solution of the present invention clearer, the technical solution of the embodiment of the present invention will be clearly and completely described below in conjunction with the drawings of specific embodiments of the present invention.

[0060] The same reference numerals in the accompanying drawings represent the same components. It should be noted that the described embodiments are only some of the embodiments of the present invention, not all of the embodiments. Based on the described embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0061] Unless otherwise defined, technical or scientific terms used herein shall have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0062] The terms "first", "second" and similar terms used in the patent application specification and claims of the present invention do not indicate any order, quantity or importance, but are only used to distinguish different components.

[0063] Similarly, words such as "a" or "an" do not necessarily indicate a quantity limitation. Words such as "include" or "comprising" mean that the elements or objects preceding the word include the elements or objects listed after the word and their equivalents, without excluding other elements or objects.

[0064] The words "connected" or "connected" and similar expressions are not limited to physical or mechanical connections but may include electrical connections, whether direct or indirect. The words "upper," "lower," "left," "right," "leading end," "trailing end," "top," and "bottom" are used only to indicate relative positional relationships. If the absolute position of the objects being described changes, the relative positional relationship may also change accordingly.

[0065] It should be noted that, unless there is a conflict, the specific features, structures, materials or characteristics described in the embodiments of the present application can be combined in an appropriate manner in any one or more embodiments or examples.

[0066] Example 1

[0067] See attached Figure 1-11 Embodiment 1 of the present invention provides a guidewire-assisted device for bifurcation lesions, the guidewire-assisted device comprising a device body 4 and a push rod 3, the proximal end 31 of the push rod being fixedly connected to the device body 4, the distal end 32 of the push rod being a handheld portion, the device body 4 comprising a main branch guidewire guide portion 42 and a branch guidewire clamping portion 41, the main branch guidewire guide portion 42 being provided with a main branch guidewire hole 421, the main branch guidewire 1 passing through the main branch guidewire hole 421, the branch guidewire clamping portion 41 being provided with a branch guidewire cavity 411, the branch guidewire cavity 411 being used to clamp and fix the branch guidewire 2, the branch guidewire cavity 411 and the main branch guidewire hole 421 being arranged in the same direction and parallel, the guidewire-assisted device being used to transport the branch guidewire 2 through the central cavity of the main branch stent into the main branch blood vessel, and to separate from the branch guidewire 2. In the embodiment of the present invention, the proximal end is the end closer to the heart when the device is in use, and the distal end is the end farther from the heart when the device is in use.

[0068] When using, Figure 6 、 Figure 11As shown, the guidewire auxiliary device provided by the embodiment of the present invention is transported into the blood vessel with the main branch guidewire 1 as the guide rail, and at the same time, the branch guidewire cavity 411 clamps the head end of the branch guidewire 2. The head end of the branch guidewire 2 may or may not protrude from the branch guidewire clamping portion 41. During the transportation process, the end of the branch guidewire 2 does not need to contact the blood vessel wall. Since the main branch guidewire 1 is used as the guide rail, the guidewire auxiliary device does not have the risk of entering the gap between the outside of the main branch stent and the blood vessel wall. At the same time, since the main branch guidewire 1 and the branch guidewire 2 are separated and supported by two different cavities, There is no risk of the two being entangled with each other during transportation, and the guidewire-assisted device can be quickly delivered to the central cavity of the main branch stent. At this time, the guidewire-assisted device continues to advance along the main branch guidewire 1 until it enters the main branch blood vessel, fixes the branch guidewire 2, and separates the branch guidewire 2 from the guidewire-assisted device by advancing the distal end 32 of the push rod or other technical means. The operator then manually pulls back the branch guidewire 2 until it reaches the opening of the branch blood vessel. At this time, the operator controls the branch guidewire 2 to cross the appropriate mesh of the main branch stent to complete the intervention of the branch guidewire. The guidewire-assisted device provided in the embodiment of the present invention can quickly deliver the branch guidewire 2 to the main branch blood vessel in the central cavity of the main branch stent, and then reach the opening of the branch blood vessel by pulling it back, avoiding the slow delivery speed of the branch guidewire 2 and the risk of entering the gap between the outside of the main branch stent and the blood vessel wall, and also avoiding the risk of the branch guidewire 2 being entangled with the main branch guidewire 1.

[0069] As a preferred embodiment of the present invention, the branch guidewire cavity 411 includes a clamping portion 4111, which is arranged near the proximal end and is used to clamp the branch guidewire 2. Through research by technical personnel, it was found that when the clamping portion 4111 is made of conventional materials, and the diameter ratio of the clamping portion 4111 to the branch guidewire 2 is between 0.985 and 0.995, preferably 0.99, the branch guidewire 2 is not easy to detach during the transportation of the guidewire auxiliary device, and when it reaches the predetermined position, the branch guidewire 2 is fixed, and the distal end 32 of the push rod is pushed forward to easily separate the branch guidewire 2 from the guidewire auxiliary device, and there will be no problem of the branch guidewire 2 falling off during transportation, or the problem of the distal end 32 of the push rod being unable to detach the branch guidewire 2 from the guidewire auxiliary device after reaching the predetermined position.

[0070] As an embodiment of the present invention, Figure 4 、 Figure 5As shown, the length of the clamping portion 4111 is 0.1-4 cm. Preferably, the length of the clamping portion 4111 is 0.1-1 cm. More preferably, the length of the clamping portion 4111 is 0.1-0.4 cm. Even more preferably, the length of the clamping portion 4111 is 0.1-0.2 cm. Considering that the branch guide wire 2 needs to be detached from the guide wire auxiliary device, the clamping portion 4111 should not be too long, otherwise a large amount of stress is easily generated and accumulated on the head when the branch guide wire 2 is pulled out. At the moment the branch guide wire 2 is pulled out, the stress release will cause the head of the branch guide wire 2 to bounce. Since the human blood vessels are not in a straight state, the branch guide wire 2 is easily subjected to uneven force during the withdrawal process, resulting in unpredictable bouncing direction, which is easy to damage the blood vessel wall and bring greater risks to the operation. Therefore, controlling the length of the clamping portion 4111 within an appropriate range can effectively prevent the branch guide wire 2 from bouncing after being pulled out from the clamping portion 4111, thereby effectively improving the safety of the operation.

[0071] As a preferred embodiment of the present invention, Figure 5The branch guidewire cavity 411 shown in the figure also includes a transition portion 4112 and a receiving portion 4113, and the receiving portion 4113 is smoothly connected to the clamping portion 4111 through the transition portion 4112. The width or diameter of the receiving portion 4113 is greater than the diameter of the branch guidewire 2. The receiving portion 4113 is used to accommodate the portion behind the head of the branch guidewire 2. Since the clamping portion 4111 is short in length, the receiving portion 4113 can be used to prevent the branch guidewire 2 from bending around the clamping portion 4111. When the branch guidewire 2 is set, the branch guidewire 2 can be controlled at both ends of the branch guidewire clamping section 4111, and placed from the top to the bottom of the branch guidewire receiving cavity 411, while the head end of the branch guidewire 2 is clamped in the clamping portion 4 111, in addition, when the branch guide wire 2 is separated from the clamping portion 4111, the accommodating portion 4113 can limit its elastic movement at the moment of separation to avoid damage to the vascular wall of the main branch blood vessel. The smooth connection between the clamping portion 4111 and the accommodating portion 4113 can prevent the edge from damaging the branch guide wire 2, and further avoid damage to the human blood vessel wall by the damaged branch guide wire 2. Preferably, the top of the accommodating portion 4113 is sealed or the top is narrow and the bottom is wide to form an accommodating channel, the width of the top is less than the diameter of the branch guide wire 2, and the bottom width is greater than the diameter of the branch guide wire 2. On the other hand, the accommodating portion 4113 can also be circular or a channel to facilitate the insertion or withdrawal of the branch guide wire 2. The use of a narrow channel setting can further prevent the branch guide wire 2 from bouncing when it detaches from the clamping portion 4111, thereby providing further protection for the blood vessel wall. When the accommodating portion 4113 forms an accommodating channel, the head end of the branch guide wire 2 passes through the tail end of the accommodating portion during the clamping setting. After the branch guide wire 2 is separated from the guidewire auxiliary device, the head end of the branch guide wire 2 is separated from the tail end of the accommodating portion 4113.

[0072] Specifically, the top of the accommodating portion 4113 is closed, or the accommodating portion 4113 extends to open at its top. Preferably, when the accommodating portion 4113 extends to open at its top, the width of the top opening of the accommodating portion 4113 is smaller than the diameter of the branch guide wire 2. It should be understood that the top of the accommodating portion 4113 refers to the Figure 6 、 Figure 7In the direction of the top of the middle, when there is an opening at the top of the accommodating portion 4113, it is conducive to the pre-assembly of the branch guide wire 2. During pre-assembly, the branch guide wire 2 can be controlled at both ends of the branch guide wire clamping portion 4111, and pressed from the top of the branch guide wire accommodating cavity 411 to the bottom, that is, the branch guide wire 2 is pressed into the clamping portion 4111 and the accommodating portion 4113 by pressing downward from the opening to complete the pre-assembly. Furthermore, in order to avoid the branch guide wire 2 from being separated from the clamping portion 4111 due to stress, Irregular bouncing causes the head of the branch guidewire 2 to pop out of the opening, causing damage to the nearby blood vessel wall. Limiting the width of the opening to be smaller than the diameter of the branch guidewire 2 can effectively avoid the above situation. In fact, the width of the opening is slightly smaller than the diameter of the branch guidewire 2. In this case, the pre-assembly of the branch guidewire 2 can be completed, and the damage to the blood vessel wall caused by the bouncing of the branch guidewire 2 can be avoided. Preferably, the width of the top opening of the accommodating portion 4113 is equal to the width of the clamping portion 4111.

[0073] As an embodiment of the present invention, the clamping portion 4111 is made of a shape memory alloy, which maintains a contracted state at low or normal temperatures and restores its memory shape within the human body temperature range. In an embodiment of the present invention, the width of the clamping portion 4111 is smaller than the diameter of the branch guide wire 2 at low or normal temperatures, and the width of the clamping portion 4111 can be restored to be greater than, equal to, or slightly smaller than the diameter of the branch guide wire 2 within the human body temperature range. The use of a shape memory alloy to make the clamping portion 4111 can make the width of the clamping portion 4111 much smaller than the diameter of the branch guide wire 2 at low or normal temperatures. Thereby, the branch guide wire 2 is less likely to fall off during the transportation of the guide wire auxiliary device. When the branch guide wire 2 reaches the predetermined position, it is heated by the human body temperature, and the width of the clamping part 4111 after heating is expanded. The branch guide wire 2 automatically detaches from the guide wire auxiliary device or is lightly clamped. A light push of the distal end 32 of the push rod can detach the branch guide wire 2 from the guide wire auxiliary device to complete the transportation. Preferably, the shape memory alloy is Ni-Ti alloy, which can form a stable passivation film to avoid harm to the human body, and has a large elastic deformation, which can better complete the transportation of the branch guide wire 2.

[0074] For the sake of convenience, in this embodiment, the width of the clamping portion 4111 made of shape memory alloy after recovery is referred to as the preset width, and the recovery time of the shape memory alloy within the human body temperature range is referred to as the recovery time.

[0075] Preferably, the ratio of the width of the clamping portion 4111 made of the above-mentioned shape memory alloy after recovery within the human body temperature range to the diameter of the branch guide wire 2 is greater than 0.985. Preferably, when the recovery time of the shape memory alloy within the human body temperature range is more than 30 seconds, the ratio of the width of the clamping portion 4111 after recovery to the diameter of the branch guide wire 2 can be pre-set to be greater than or equal to 0.995. When the recovery time of the shape memory alloy within the human body temperature range is less than 30 seconds, the ratio of the width of the clamping portion 4111 after recovery to the diameter of the branch guide wire 2 can be pre-set to be 0.985~0.995. When using the guidewire-assisting device provided by the present invention to deliver the branch guidewire 2, the operator can deliver the guidewire-assisting device to the predetermined position in about 30 seconds, so the preset width needs to be set according to the recovery time. If the recovery time is less than 30 seconds, the preset width needs to be relatively small to prevent the branch guidewire 2 from automatically falling off during the delivery process. At the same time, after it reaches the predetermined position, the distal end 32 of the pushing rod can also be gently pushed to complete the separation of the branch guidewire 2 from the guidewire-assisting device. If the recovery time is more than 30 seconds, the preset width can be appropriately relaxed. If the operator is proficient in operation, the preset width can be set larger than the diameter of the branch guidewire 2. In this case, when the operator delivers the guidewire-assisting device to the predetermined position, within the human body temperature range, the shape memory metal restores the preset width, and the branch guidewire 2 can be automatically separated from the guidewire-assisting device. In this case, the stress concentration during pushing by the pushing rod 3 can be avoided, and the optimal state of no bounce when the branch guidewire 2 is separated from the guidewire-assisting device can be achieved.

[0076] Optional, such as Figure 7 、 Figure 9 As shown, one or more X-ray positioning marks 21 are provided on the branch guidewire 2, and the X-ray positioning marks 21 are provided at one or both ends of the branch guidewire 2. The X-ray positioning marks 21 can be sensed by X-rays. Providing the X-ray positioning marks 21 on the branch guidewire 2 can facilitate the surgeon to quickly locate the position of the branch guidewire 2 during surgery. When the guidewire auxiliary device reaches the predetermined position, the distal end 32 of the push rod is quickly pushed to separate the branch guidewire 2 from the guidewire auxiliary device. At the same time, the branch guidewire 2 and the main branch guidewire 1 can also be quickly distinguished, thereby preventing operational errors, thereby saving surgical time and improving the success rate of surgery.

[0077] As a preferred embodiment of the present invention, Figure 1 、 Figure 2As shown, the leading and trailing ends of the branch guidewire clamping portion 41 are streamlined, as are the leading and trailing ends of the main branch guidewire guiding portion 42. Preferably, the leading and trailing ends of the branch guidewire clamping portion 41 and the leading and trailing ends of the main branch guidewire guiding portion 42 are conical. Since surgery is typically performed within arterial vessels, special attention must be paid to protecting the vessel walls. The streamlined design prevents the edges or head of the guidewire assist device from contacting the vessel walls during delivery, causing unnecessary damage and improving surgical safety.

[0078] Preferably, the entire guidewire-assisted device is coated with an ultra-slip coating or a hydrophilic coating. Since the guidewire-assisted device needs to be inserted and removed through blood vessels during surgery, the use of an ultra-slip coating or a hydrophilic coating can change the surface friction coefficient of the guidewire-assisted device, typically reducing it by more than 98%, thereby forming a lubricated surface. This lubricated surface can reduce the force of the guidewire-assisted device's insertion and allow it to pass through blood vessels more easily, avoiding possible puncture or friction damage.

[0079] As an embodiment of the present invention, the main guide wire guide portion 42 and the branch guide wire clamping portion 41 can be integrally formed or separately fixedly connected, and the lengths of the two in the radial direction of the push rod 3 can be the same or different. When the lengths of the two are the same, such as Figure 11 As shown, the two can also be combined to form a sphere or spindle shape, and the main branch guide wire guide portion 42 can also be set to one or more rings or any structure that can use the main branch guide wire 1 as a guide rail.

[0080] In some embodiments of the present invention, the device body 4, the push rod 3, and the branch guide wire clamping portion 41 are made of the same material. In other embodiments, the device body 4, the push rod 3, and the branch guide wire clamping portion 41 are made of different materials. Specifically, the device body 4, the push rod 3, and the branch guide wire clamping portion 41 are all made of metal, or the device body 4, the push rod 3, and the branch guide wire clamping portion 41 are all made of non-metallic materials, or at least one of the device body 4, the push rod 3, and the branch guide wire clamping portion 41 is made of metal and at least one is made of non-metallic material. By changing the materials of the device body 4, the push rod 3 and the branch guide wire clamping part 41, the usage requirements in multiple scenarios can be met. When the patient needs to undergo cancer surgery or emergency surgery, the patient usually uses an all-metal heart stent. At this time, a guidewire auxiliary device can be used in which the device body 4, the push rod 3 and the branch guide wire clamping part 41 are all metal or partially metal, which can more effectively protect the branch guide wire 2. When the patient uses a bioabsorbable heart stent, a non-metallic device body 4, the push rod 3 and the branch guide wire clamping part 41 can be used to reduce damage to the human body.

[0081] The guidewire assist device provided by the embodiment of the present invention includes but is not limited to the following Figure 1-11 Any device that can clamp the branch guide wire 2 and release it at a predetermined position falls within the scope of the disclosure of the embodiments of the present invention.

[0082] The method of using the guidewire assist device provided by the present invention is as follows:

[0083] S1: pre-setting a branch guidewire 2 on the guidewire assist device;

[0084] S2: Before the operation, the main branch guide wire 1 is passed through the main branch guide wire hole 421 and delivered into position; or when the main branch guide wire 1 is already in position, the guide wire auxiliary device is placed on the main branch guide wire 1 from the tail end of the main branch guide wire 1;

[0085] S3: Using the main branch guidewire 1 as a guide, the guidewire-assisted device is pushed into the blood vessel using the push rod 3 until the guidewire-assisted device passes through the central lumen of the main branch stent and enters the predetermined position in the main branch blood vessel. During this period, the X-ray positioning marker 21 can be used for positioning;

[0086] S4: When the guidewire-assisting device reaches the predetermined position, the branch guidewire 2 is fixed, and the operator gently pushes the distal end 32 of the push rod to separate the branch guidewire 2 from the guidewire-assisting device; when made of a shape memory alloy with a recovery time of more than 30 seconds, the branch guidewire 2 can be automatically separated from the guidewire-assisting device.

[0087] S5: Pull back the branch guidewire 2 until it reaches the opening of the branch blood vessel.

[0088] When the clamping portion 4111 is made of conventional material, S1 can be achieved by the following steps:

[0089] S11: When the accommodating portion 4113 is a channel, the guidewire auxiliary device is heated to expand it, and then the branch guidewire 2 is passed through the tail end of the accommodating portion 4113 and into the clamping portion 4111. When the top of the accommodating portion 4113 is an opening, the branch guidewire 2 is held and pressed down at both ends of the branch guidewire cavity 411 to embed the branch guidewire 2 into the clamping portion 4111.

[0090] S12: Cool the guidewire auxiliary device to ensure that the clamping portion 4111 holds and fixes the branch guidewire 2 so that the branch guidewire 2 will not fall off when the distal end 32 of the push rod is pushed.

[0091] When the clamping portion 4111 is made of a shape memory alloy, S1 can be implemented by the following steps:

[0092] S11, presetting the preset width according to the recovery time;

[0093] S12: When the accommodating portion 4113 is a channel, heat the guidewire auxiliary device to expand it, and then pass the branch guidewire 2 through the tail end of the accommodating portion 4113 into the clamping portion 4111. When the top of the accommodating portion 4113 is an opening, hold the branch guidewire 2 and press down at both ends of the branch guidewire cavity 411 to embed the branch guidewire 2 into the clamping portion 4111.

[0094] S13. Cooling the guidewire auxiliary device causes the clamping portion 4111 to narrow at low temperature, thereby firmly clamping the branch guidewire 2.

[0095] Example 2

[0096] Embodiment 2 of the present invention provides a guidewire auxiliary device for bifurcation lesions, the guidewire auxiliary device includes a device body 4 and a push rod 3, the two ends of the push rod 3 are a push rod proximal end 31 and a push rod distal end 32, the push rod proximal end 31 is fixedly connected to the device body 4, the push rod distal end 32 is a handheld portion, the device body 4 includes a main branch guide wire guide portion 42 and a branch guide wire clamping portion 41, the main branch guide wire guide portion 42 is provided with a main branch guide wire hole 421 The main branch guidewire 1 passes through the main branch guidewire hole 421, and the branch guidewire clamping portion 41 is provided with a branch guidewire cavity 411, and the branch guidewire cavity 411 is used to clamp and fix the branch guidewire 2. The branch guidewire cavity 411 and the main branch guidewire hole 421 are arranged in the same direction and parallel. The guidewire auxiliary device is used to transport the branch guidewire 2 through the central cavity of the main branch stent into the main branch blood vessel and separate from the branch guidewire 2. The device body 4 and / or the push rod 3 gradually become thicker from the distal end to the proximal end. In an embodiment of the present invention, the proximal end is the end closer to the heart when the device is in use, and the distal end is the end farther from the heart when the device is in use. The setting of gradually becoming thicker from the distal end to the proximal end makes the advancement and removal of the guidewire auxiliary device smoother during use, while reducing the blockage effect on the blood vessels. Since the head end of the guidewire auxiliary device is thicker, as long as the head end can reach the place, there is no need to worry about scraping between the rear end and the blood vessel wall. The placement speed of the guidewire auxiliary device can be accelerated, and the branch guidewire 2 can be put in place faster, significantly shortening the operation time.

[0097] When using, such as Figure 6 、 Figure 11As shown, the guidewire auxiliary device provided by the embodiment of the present invention is transported into the blood vessel with the main branch guidewire 1 as the guide rail, and at the same time, the branch guidewire cavity 411 clamps the head end of the branch guidewire 2. The head end of the branch guidewire 2 may or may not protrude from the branch guidewire clamping portion 41. During the transportation process, the end of the branch guidewire 2 does not need to contact the blood vessel wall. Since the main branch guidewire 1 is used as the guide rail, the guidewire auxiliary device does not have the risk of entering the gap between the outside of the main branch stent and the blood vessel wall. At the same time, since the main branch guidewire 1 and the branch guidewire 2 are separated and supported by two different cavities, There is no risk of the two being entangled with each other during transportation, and the guidewire-assisted device can be quickly delivered to the central cavity of the main branch stent. At this time, the guidewire-assisted device continues to advance along the main branch guidewire 1 until it enters the main branch blood vessel, fixes the branch guidewire 2, and separates the branch guidewire 2 from the guidewire-assisted device by advancing the distal end 32 of the push rod or other technical means. The operator then manually pulls back the branch guidewire 2 until it reaches the opening of the branch blood vessel. At this time, the operator controls the branch guidewire 2 to cross the appropriate mesh of the main branch stent to complete the intervention of the branch guidewire. The guidewire-assisted device provided in the embodiment of the present invention can quickly deliver the branch guidewire 2 to the main branch blood vessel in the central cavity of the main branch stent, and then reach the opening of the branch blood vessel by pulling it back, avoiding the slow delivery speed of the branch guidewire 2 and the risk of entering the gap between the outside of the main branch stent and the blood vessel wall, and also avoiding the risk of the branch guidewire 2 being entangled with the main branch guidewire 1.

[0098] As a preferred embodiment of the present invention, the branch guidewire cavity 411 includes a clamping portion 4111, which is arranged near the proximal end and is used to clamp the branch guidewire 2. Through research by technical personnel, it was found that when the clamping portion 4111 is made of conventional materials, and the diameter ratio of the clamping portion 4111 to the branch guidewire 2 is between 0.985 and 0.995, preferably 0.99, the branch guidewire 2 is not easy to detach during the transportation of the guidewire auxiliary device, and when it reaches the predetermined position, the branch guidewire 2 is fixed, and the distal end 32 of the push rod is pushed forward to easily separate the branch guidewire 2 from the guidewire auxiliary device, and there will be no problem of the branch guidewire 2 falling off during transportation, or the problem of the distal end 32 of the push rod being unable to detach the branch guidewire 2 from the guidewire auxiliary device after reaching the predetermined position.

[0099] As an embodiment of the present invention, Figure 4 、 Figure 5As shown, the length of the clamping portion 4111 is 0.1-4 cm. Preferably, the length of the clamping portion 4111 is 0.1-1 cm. More preferably, the length of the clamping portion 4111 is 0.1-0.4 cm. Even more preferably, the length of the clamping portion 4111 is 0.1-0.2 cm. Considering that the branch guide wire 2 needs to be detached from the guide wire auxiliary device, the clamping portion 4111 should not be too long, otherwise a large amount of stress is easily generated and accumulated on the head when the branch guide wire 2 is pulled out. At the moment the branch guide wire 2 is pulled out, the stress release will cause the head of the branch guide wire 2 to bounce. Since the human blood vessels are not in a straight state, the branch guide wire 2 is easily subjected to uneven force during the withdrawal process, resulting in unpredictable bouncing direction, which is easy to damage the blood vessel wall and bring greater risks to the operation. Therefore, controlling the length of the clamping portion 4111 within an appropriate range can effectively prevent the branch guide wire 2 from bouncing after being pulled out from the clamping portion 4111, thereby effectively improving the safety of the operation.

[0100] As a preferred embodiment of the present invention, Figure 5The branch guidewire cavity 411 shown in the figure also includes a transition portion 4112 and a receiving portion 4113, and the receiving portion 4113 is smoothly connected to the clamping portion 4111 through the transition portion 4112. The width or diameter of the receiving portion 4113 is greater than the diameter of the branch guidewire 2. The receiving portion 4113 is used to accommodate the portion behind the head of the branch guidewire 2. Since the clamping portion 4111 is short in length, the receiving portion 4113 can be used to prevent the branch guidewire 2 from bending around the clamping portion 4111. When the branch guidewire 2 is set, the branch guidewire 2 can be controlled at both ends of the branch guidewire clamping section 4111, and placed from the top to the bottom of the branch guidewire receiving cavity 411, while the head end of the branch guidewire 2 is clamped in the clamping portion 4 111, in addition, when the branch guide wire 2 is separated from the clamping portion 4111, the accommodating portion 4113 can limit its elastic movement at the moment of separation to avoid damage to the vascular wall of the main branch blood vessel. The smooth connection between the clamping portion 4111 and the accommodating portion 4113 can prevent the edge from damaging the branch guide wire 2, and further avoid damage to the human blood vessel wall by the damaged branch guide wire 2. Preferably, the top of the accommodating portion 4113 is sealed or the top is narrow and the bottom is wide to form an accommodating channel, the width of the top is less than the diameter of the branch guide wire 2, and the bottom width is greater than the diameter of the branch guide wire 2. On the other hand, the accommodating portion 4113 can also be circular or a channel to facilitate the insertion or withdrawal of the branch guide wire 2. The use of a narrow channel setting can further prevent the branch guide wire 2 from bouncing when it detaches from the clamping portion 4111, thereby providing further protection for the blood vessel wall. When the accommodating portion 4113 forms an accommodating channel, the head end of the branch guide wire 2 passes through the tail end of the accommodating portion during the clamping setting. After the branch guide wire 2 is separated from the guidewire auxiliary device, the head end of the branch guide wire 2 is separated from the tail end of the accommodating portion 4113.

[0101] Specifically, the top of the accommodating portion 4113 is closed, or the accommodating portion 4113 extends to open at its top. Preferably, when the accommodating portion 4113 extends to open at its top, the width of the top opening of the accommodating portion 4113 is smaller than the diameter of the branch guide wire 2. It should be understood that the top of the accommodating portion 4113 refers to the Figure 6 、 Figure 7In the direction of the top of the middle, when there is an opening at the top of the accommodating portion 4113, it is conducive to the pre-assembly of the branch guide wire 2. During pre-assembly, the branch guide wire 2 can be controlled at both ends of the branch guide wire clamping portion 4111, and pressed from the top of the branch guide wire accommodating cavity 411 to the bottom, that is, the branch guide wire 2 is pressed into the clamping portion 4111 and the accommodating portion 4113 by pressing downward from the opening to complete the pre-assembly. Furthermore, in order to avoid the branch guide wire 2 from being separated from the clamping portion 4111 due to stress, Irregular bouncing causes the head of the branch guidewire 2 to pop out of the opening, causing damage to the nearby blood vessel wall. Limiting the width of the opening to be smaller than the diameter of the branch guidewire 2 can effectively avoid the above situation. In fact, the width of the opening is slightly smaller than the diameter of the branch guidewire 2. In this case, the pre-assembly of the branch guidewire 2 can be completed, and the damage to the blood vessel wall caused by the bouncing of the branch guidewire 2 can be avoided. Preferably, the width of the top opening of the accommodating portion 4113 is equal to the width of the clamping portion 4111.

[0102] As an embodiment of the present invention, the clamping portion 4111 is made of a shape memory alloy, which maintains a contracted state at low or normal temperatures and restores its memory shape within the human body temperature range. In an embodiment of the present invention, the width of the clamping portion 4111 is smaller than the diameter of the branch guide wire 2 at low or normal temperatures, and the width of the clamping portion 4111 can be restored to be greater than, equal to, or slightly smaller than the diameter of the branch guide wire 2 within the human body temperature range. The use of a shape memory alloy to make the clamping portion 4111 can make the width of the clamping portion 4111 much smaller than the diameter of the branch guide wire 2 at low or normal temperatures. Thereby, the branch guide wire 2 is less likely to fall off during the transportation of the guide wire auxiliary device. When the branch guide wire 2 reaches the predetermined position, it is heated by the human body temperature, and the width of the clamping part 4111 after heating is expanded. The branch guide wire 2 automatically detaches from the guide wire auxiliary device or is lightly clamped. A light push of the distal end 32 of the push rod can detach the branch guide wire 2 from the guide wire auxiliary device to complete the transportation. Preferably, the shape memory alloy is Ni-Ti alloy, which can form a stable passivation film to avoid harm to the human body, and has a large elastic deformation, which can better complete the transportation of the branch guide wire 2.

[0103] For the sake of convenience, in this embodiment, the width of the clamping portion 4111 made of shape memory alloy after recovery is referred to as the preset width, and the recovery time of the shape memory alloy within the human body temperature range is referred to as the recovery time.

[0104] Preferably, the ratio of the width of the clamping portion 4111 made of the above-mentioned shape memory alloy after recovery within the human body temperature range to the diameter of the branch guide wire 2 is greater than 0.985. Preferably, when the recovery time of the shape memory alloy within the human body temperature range is more than 30 seconds, the ratio of the width of the clamping portion 4111 after recovery to the diameter of the branch guide wire 2 can be pre-set to be greater than or equal to 0.995. When the recovery time of the shape memory alloy within the human body temperature range is less than 30 seconds, the ratio of the width of the clamping portion 4111 after recovery to the diameter of the branch guide wire 2 can be pre-set to be 0.985~0.995. When using the guidewire-assisting device provided by the present invention to deliver the branch guidewire 2, the operator can deliver the guidewire-assisting device to the predetermined position in about 30 seconds, so the preset width needs to be set according to the recovery time. If the recovery time is less than 30 seconds, the preset width needs to be relatively small to prevent the branch guidewire 2 from automatically falling off during the delivery process. At the same time, after it reaches the predetermined position, the distal end 32 of the pushing rod can also be gently pushed to complete the separation of the branch guidewire 2 from the guidewire-assisting device. If the recovery time is more than 30 seconds, the preset width can be appropriately relaxed. If the operator is proficient in operation, the preset width can be set larger than the diameter of the branch guidewire 2. In this case, when the operator delivers the guidewire-assisting device to the predetermined position, within the human body temperature range, the shape memory metal restores the preset width, and the branch guidewire 2 can be automatically separated from the guidewire-assisting device. In this case, the stress concentration during pushing by the pushing rod 3 can be avoided, and the optimal state of no bounce when the branch guidewire 2 is separated from the guidewire-assisting device can be achieved.

[0105] Optional, such as Figure 7 、 Figure 9 As shown, one or more X-ray positioning marks 21 are provided on the branch guidewire 2, and the X-ray positioning marks 21 are provided at one or both ends of the branch guidewire 2. The X-ray positioning marks 21 can be sensed by X-rays. Providing the X-ray positioning marks 21 on the branch guidewire 2 can facilitate the surgeon to quickly locate the position of the branch guidewire 2 during surgery. When the guidewire auxiliary device reaches the predetermined position, the distal end 32 of the push rod is quickly pushed to separate the branch guidewire 2 from the guidewire auxiliary device. At the same time, the branch guidewire 2 and the main branch guidewire 1 can also be quickly distinguished, thereby preventing operational errors, thereby saving surgical time and improving the success rate of surgery.

[0106] As a preferred embodiment of the present invention, Figure 1 、 Figure 2As shown, the leading and trailing ends of the branch guidewire clamping portion 41 are streamlined, as are the leading and trailing ends of the main branch guidewire guiding portion 42. Preferably, the leading and trailing ends of the branch guidewire clamping portion 41 and the leading and trailing ends of the main branch guidewire guiding portion 42 are conical. Since surgery is typically performed within arterial vessels, special attention must be paid to protecting the vessel walls. The streamlined design prevents the edges or head of the guidewire assist device from contacting the vessel walls during delivery, causing unnecessary damage and improving surgical safety.

[0107] Preferably, the entire guidewire-assisted device is coated with an ultra-slip coating or a hydrophilic coating. Since the guidewire-assisted device needs to be inserted and removed through blood vessels during surgery, the use of an ultra-slip coating or a hydrophilic coating can change the surface friction coefficient of the guidewire-assisted device, typically reducing it by more than 98%, thereby forming a lubricated surface. This lubricated surface can reduce the force of the guidewire-assisted device's insertion and allow it to pass through blood vessels more easily, avoiding possible puncture or friction damage.

[0108] As an embodiment of the present invention, the main guide wire guide portion 42 and the branch guide wire clamping portion 41 can be integrally formed or separately fixedly connected, and the lengths of the two in the radial direction of the push rod 3 can be the same or different. When the lengths of the two are the same, such as Figure 11 As shown, the two can also be combined to form a sphere or spindle shape, and the main branch guide wire guide portion 42 can also be set to one or more rings or any structure that can use the main branch guide wire 1 as a guide rail.

[0109] In some embodiments of the present invention, the device body 4, the push rod 3, and the branch guide wire clamping portion 41 are made of the same material. In other embodiments, the device body 4, the push rod 3, and the branch guide wire clamping portion 41 are made of different materials. Specifically, the device body 4, the push rod 3, and the branch guide wire clamping portion 41 are all made of metal, or the device body 4, the push rod 3, and the branch guide wire clamping portion 41 are all made of non-metallic materials, or at least one of the device body 4, the push rod 3, and the branch guide wire clamping portion 41 is made of metal and at least one is made of non-metallic material. By changing the materials of the device body 4, the push rod 3 and the branch guide wire clamping part 41, the usage requirements in multiple scenarios can be met. When the patient needs to undergo cancer surgery or emergency surgery, the patient usually uses an all-metal heart stent. At this time, a guidewire auxiliary device can be used in which the device body 4, the push rod 3 and the branch guide wire clamping part 41 are all metal or partially metal, which can more effectively protect the branch guide wire 2. When the patient uses a bioabsorbable heart stent, a non-metallic device body 4, the push rod 3 and the branch guide wire clamping part 41 can be used to reduce damage to the human body.

[0110] Example 3

[0111] This embodiment discloses a medical device, which includes the guidewire assist device described in Example 1.

[0112] The specific structure and effects of the medical device will not be described in detail here.

[0113] The exemplary embodiments of the present invention are described in detail above with reference to preferred embodiments and cases. However, it will be understood by those skilled in the art that, without departing from the concept of the present invention, various variations and modifications may be made to the above-mentioned specific embodiments, and various technical features and structures proposed in the present invention may be combined in various ways without exceeding the scope of protection of the present invention.

Claims

1. A guidewire-assisted device for bifurcation lesions, characterized in that: The device comprises a main body (4) and a push rod (3), wherein the proximal end (31) of the push rod is fixedly connected to the main body (4), and the distal end (32) of the push rod is a handheld part. The main body (4) comprises a main branch guide wire guiding part (42) and a branch guide wire clamping part (41), wherein the main branch guide wire guiding part (42) is provided with a main branch guide wire hole (421), and the main branch guide wire (1) passes through the main branch guide wire hole (421), and the branch guide wire clamping part (41) is provided with a branch guide wire cavity (411), and the branch guide wire cavity (411) is used to clamp and fix the branch guide wire (2); The guidewire auxiliary device uses the main branch guidewire (1) as a guide rail to pass through the central cavity of the main branch stent and enter the main branch blood vessel. When the distal end (32) of the push rod is pushed, the branch guidewire (2) will not fall off. When the guidewire auxiliary device reaches the predetermined position, the branch guidewire (2) is fixed, and the distal end (32) of the push rod is gently pushed. The branch guidewire (2) is separated from the guidewire auxiliary device, and the branch guidewire (2) is pulled back until it reaches the opening of the branch blood vessel.

2. The guidewire assist device according to claim 1, characterized in that The branch guidewire cavity (411) comprises a clamping portion (4111), the clamping portion (4111) being arranged close to the proximal end, and the clamping portion (4111) being used to clamp the branch guidewire (2).

3. The guidewire assist device according to claim 2, characterized in that The length of the clamping portion (4111) is 0.1-4 cm.

4. The guidewire assist device according to claim 2, characterized in that The length of the clamping portion (4111) is 0.1-1 cm.

5. The guidewire assist device according to claim 2, characterized in that: The length of the clamping portion (4111) is 0.1-0.4 cm.

6. The guidewire assist device according to claim 2, characterized in that: The length of the clamping portion (4111) is 0.1-0.2 cm.

7. The guidewire assist device according to claim 3, characterized in that: The clamping portion (4111) is made of a shape memory alloy, and the width of the clamping portion (4111) remains in a reduced state at low or normal temperatures, and recovers the memory shape within the human body temperature range.

8. The guidewire assist device according to claim 7, characterized in that: When the recovery time of the shape memory alloy within the human body temperature range is more than 30 seconds, the ratio of the width of the clamping portion (4111) after the memory shape is restored to the diameter of the branch guide wire (2) is more than 0.995; when the recovery time of the shape memory alloy within the human body temperature range is less than 30 seconds, the ratio of the width of the clamping portion (4111) after the memory shape is restored to the diameter of the branch guide wire (2) is between 0.985 and 0.

995.

9. The guidewire assist device according to claim 1, characterized in that: The head end and tail end of the branch guidewire clamping portion (41) are both streamlined, the head end and tail end of the main branch guidewire guiding portion (42) are both streamlined, and the entire guidewire auxiliary device is coated with a super-slip coating or a hydrophilic coating.

10. The guidewire assist device according to any one of claims 1 to 9, characterized in that: The device body (4) and the push rod (3) are made of the same material, or the device body (4) and the push rod (3) are made of different materials.

11. The guidewire assist device according to claim 10, characterized in that: The device body (4) and the push rod (3) are both made of metal, or the device body (4) and the push rod (3) are both made of non-metal, or one of the device body (4) and the push rod (3) is made of metal and the other is made of non-metal.

12. A medical device, characterized in that: The medical device comprises the guidewire assist device according to any one of claims 1 to 11.

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