A pre-dilation guidewire

Abstract

The utility model provides a kind of pre-dilation guide wire, it is characterized by, including balloon, first cutting hypotube, first connecting pipe and hollow tube, the air inlet of the balloon is sealingly connected with the air outlet of the first connecting pipe, the air inlet of the first connecting pipe is sealingly connected with the air outlet of the hollow tube, one end of the first cutting hypotube is penetrated along the axial direction of first connecting pipe The utility model integrates balloon directly in guide wire body, realizes pre-dilation function, so that guide wire can immediately carry out pre-dilation after crossing lesion without replacing instrument, significantly simplify surgical procedure, shorten operation time, effectively avoid the risk of vascular injury caused by multiple instrument exchange;At the same time, the setting of safety wire can improve the tensile strength of guide wire distal end, improve product safety and twist control, so that core wire is more easily controlled.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a pre-expanded guidewire. Background Technology

[0002] Guidewires are key instruments in interventional medicine, typically made of metal or polymer materials. They are long, thin, and flexible, and widely used in minimally invasive surgery and vascular / cavitary interventional treatments. Their main function is to establish delivery paths for catheters, balloons, stents, and other devices, guiding them safely and accurately to the target lesion site while minimizing damage to blood vessels or tissues. Therefore, they play an irreplaceable role in interventional medicine. In interventional treatment of ischemic cardiovascular and cerebrovascular diseases, the guidewire is usually first passed through the narrowed or occluded lesion segment, and then a balloon catheter or stent is delivered along the guidewire to the target location for dilation or implantation. However, in actual clinical practice, the guidewire must first pass through the lesion, then a balloon is delivered along the guidewire for pre-dilation, and finally a stent or other therapeutic device is delivered. This existing technology requires multiple instrument changes, making the procedure cumbersome, prolonging the operation time, reducing surgical efficiency, and potentially increasing surgical risks such as vascular injury. Utility Model Content

[0003] Therefore, one objective of this invention is to propose a pre-expanded guidewire to solve the problems mentioned in the background art and overcome the shortcomings of the prior art.

[0004] To achieve the above objectives, this utility model provides a pre-expanded guidewire, including a balloon, a first cutting sub-tube, a first connecting tube, and a hollow tube. The air inlet of the balloon is sealed to the air outlet of the first connecting tube, and the air inlet of the first connecting tube is sealed to the air outlet of the hollow tube. One end of the first cutting sub-tube passes through the first connecting tube along the axial direction of the first connecting tube.

[0005] Preferably, it also includes a second connecting tube, and the balloon is also provided with an open end. The open end of the balloon is sealed to one end of the second connecting tube, the other end of the second connecting tube is sealed, and the other end of the first cutting sodium thiosulfate tube is inserted into the second connecting tube.

[0006] In any of the above embodiments, it is preferred to further include a spring and a core wire, the spring being connected to the second connecting tube, and one end of the core wire passing through the spring and inserted into the other end of the first cutting sodium thiosulfate tube.

[0007] In any of the above embodiments, it is preferred that the balloon is an eccentric balloon, the eccentric balloon includes an asymmetrically arranged expansion portion, the first cut sub-tube has a slot, and the expansion portion of the eccentric balloon is located in the slot of the first cut sub-tube.

[0008] In any of the above solutions, it is preferred that the hollow tube is replaced with a second cut thiocyanate tube, the outer diameter of which is larger than that of the first cut thiocyanate tube.

[0009] In any of the above embodiments, it is preferred to further include an inner spring, which is sleeved on the outside of the core wire.

[0010] In any of the above embodiments, it is preferred that a developing ring is also included, with a developing ring respectively provided on the first connecting tube and the second connecting tube.

[0011] In any of the above options, the preferred type of balloon is a notched balloon, a mastoid balloon, or a drug-loaded balloon.

[0012] In any of the above embodiments, it is preferred to further include a head end and a safety wire, wherein the head end is connected to the other end of the core wire, and the safety wire is welded to the head end.

[0013] Compared with the prior art, the advantages and beneficial effects of this utility model are as follows:

[0014] This invention provides a pre-dilatation guidewire that integrates a balloon directly into the guidewire body to achieve pre-dilatation. This allows the guidewire to be pre-dilated immediately after passing through the lesion without the need to change instruments, significantly simplifying the surgical procedure, shortening the operation time, and effectively avoiding the risk of vascular damage caused by multiple instrument exchanges. At the same time, the safety wire can improve the tensile strength of the distal end of the guidewire, enhance the product's safety and torsional control, and make the core wire easier to manipulate.

[0015] Additional aspects and advantages of this invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0016] The above and / or additional aspects and advantages of this utility model will become apparent and readily understood from the description of the embodiments taken in conjunction with the following drawings, in which:

[0017] Figure 1 This is a front view of a pre-expanded guidewire according to an embodiment of the present invention;

[0018] Figure 2 This is a cross-sectional view of a pre-expanded guidewire according to an embodiment of the present invention;

[0019] Figure 3 This is a schematic diagram of the structure of a first cutting thiopanacea tube according to an embodiment of the present invention;

[0020] Figure 4 This is a diagram showing the state of an eccentric balloon with a pre-dilated guidewire after inflatation according to an embodiment of the present invention.

[0021] Figure 5This is a diagram showing the unpressurized state of an eccentric balloon with a pre-dilated guidewire according to an embodiment of the present invention.

[0022] Figure 6 This is a partially enlarged view of a pre-expanded guidewire according to an embodiment of the present invention.

[0023] Wherein: 1-Balloon; 2-First cutting tube; 3-First connecting tube; 4-Hollow tube; 5-Second connecting tube; 6-Spring; 7-Core wire; 8-Eccentric balloon; 9-Head end; 10-Safety wire. Detailed Implementation

[0024] The embodiments of this utility model are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain this utility model, and should not be construed as limiting this utility model.

[0025] In this utility model, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model according to the specific circumstances.

[0026] like Figures 1 to 6 As shown, a pre-expanded guidewire according to an embodiment of the present invention includes a balloon 1, a first cutting tube 2, a first connecting tube 3, and a hollow tube 4. The air inlet of the balloon 1 is sealed to the air outlet of the first connecting tube 3, and the air inlet of the first connecting tube 3 is sealed to the air outlet of the hollow tube 4. One end of the first cutting tube 2 passes through the first connecting tube 3 along the axial direction of the first connecting tube 3.

[0027] The balloon 1 is directly integrated into the guidewire body to achieve pre-dilation function, which allows the guidewire to be pre-dilated immediately after passing through the lesion without changing instruments, which significantly simplifies the surgical procedure, shortens the operation time, and effectively avoids the risk of vascular damage caused by multiple instrument exchanges. The first cutting hypotube 2 can improve the flexibility of the guidewire and make it feasible to inflate the balloon 1. The balloon 1, the first cutting hypotube 2, the first connecting tube 3 and the hollow tube 4 are connected in series to ensure that gas flows from the air inlet of the hollow tube 4 to the balloon 1 to complete the inflation and dilation of the balloon 1.

[0028] The balloon 1 can be a compliant balloon, a semi-compliant balloon, or a non-compliant balloon. The material of the balloon 1 can be a polymer material such as PVC, PE, TPU, PET, or nylon. The connection method between the balloon 1 and the first connecting tube 3 can be laser welding, bonding, etc. The material of the first cutting tube 2 can be stainless steel, nickel-titanium, or other metal materials. The first cutting tube 2 can be a whole-section cutting structure or a segmented cutting structure. The material of the hollow tube 4 is nickel-titanium, stainless steel, or other metal materials. Optionally, the first cutting tube 2 can be replaced by a spring 6.

[0029] As one possible implementation, it also includes a second connecting tube 5, and the balloon 1 is also provided with an open end. The open end of the balloon 1 is sealed to one end of the second connecting tube 5, the other end of the second connecting tube 5 is sealed, and the other end of the first cutting sodium tube 2 is inserted into the second connecting tube 5.

[0030] The first cutting tube 2 passes through the first connecting tube 3 and the second connecting tube 5. The other end of the second connecting tube 5 is sealed to realize the pressurization function of the balloon 1 and ensure the inflation effect of the balloon 1. The surfaces of the first connecting tube 3 and the second connecting tube 5 are coated with a polymer protective layer. The polymer protective layer can improve smoothness. The polymer protective layer material can be TPU, PEBAX, PE, PP and other polymer materials. The production process is dip coating, spraying, brushing, lamination heat shrinking, etc.

[0031] As one possible implementation, it also includes a spring 6 and a core wire 7, with the spring 6 connected to the second connecting tube 5, and one end of the core wire 7 passing through the spring 6 and inserted into the other end of the first cutting sodium thiosulfate tube 2.

[0032] The core wire 7 enhances the radioactivity of the catheter, enabling precise positioning and path tracking of the guidewire. The core wire 7 and the first cutting sub-tube 2 form a precise fit structure, jointly achieving effective sealing of the second connecting tube 5. Optionally, the length of the core wire 7 can be increased, and the other end of the core wire 7 can be welded to the hollow tube to enhance the overall structural integrity. Optionally, the core wire 7 can be replaced with a sub-tube structure to seal the other end of the second connecting tube 5. A polymer sheath covers the entire guidewire from balloon 1 to tip 9, reducing manufacturing complexity and improving guidewire torsion control.

[0033] The core wire 7 can be made of nickel-titanium, stainless steel or other metal materials, and the spring 6 can be made of stainless steel, nickel-titanium, platinum-based alloy or other metal materials; the connection method between the core wire 7 and the spring 6 is brazing, laser welding, argon arc welding, plasma welding or other metal connection methods.

[0034] In one possible implementation, the balloon 1 is an eccentric balloon 8, which includes an asymmetrically arranged expansion portion. The first cut-thickness tube 2 is provided with a slot, and the expansion portion of the eccentric balloon 8 is located in the slot of the first cut-thickness tube 2.

[0035] The first cutting tube 2 is laterally cut, so that 30% of the first cutting tube 2 is vertically cut to form a groove. In the delivery state, the main body of the eccentric balloon 8 is inside the first cutting tube 2. During the expansion process, under the action of pressure, the expansion part of the eccentric balloon 8 protrudes outward from the groove of the first cutting tube 2, forming an eccentric expansion shape biased towards the groove side of the first cutting tube 2, pre-dilatating the lesion site. After the pre-dilatation is completed, the balloon 1 is withdrawn into the first cutting tube 2 to allow subsequent instruments to pass through.

[0036] As one possible implementation, the hollow tube 4 is replaced with a second cut thiocyanate tube, the outer diameter of which is larger than the outer diameter of the first cut thiocyanate tube 2.

[0037] Using first-cut thiopanel tubes 2 and second-cut thiopanel tubes with different inner and outer diameters, and connecting first-cut thiopanel tubes 2 and second-cut thiopanel tubes of different sizes through metal welding methods such as laser welding and brazing, this combination structure of different diameter tubes significantly improves the torque transmission efficiency of the guide wire; optionally, grinding is performed on the first-cut thiopanel tube 2, which greatly improves the torque control response sensitivity of the guide wire.

[0038] As one possible implementation, an inner spring is also included, which is sleeved on the outside of the core wire 7.

[0039] An inner spring is added to the outside of the core wire 7 to improve the plasticity and torsional control of the core wire 7, thereby better meeting the operational needs of interventional treatment of complex lesions; the inner spring can be made of stainless steel, nickel-titanium, platinum-based alloy or other metal materials.

[0040] As one possible implementation, it also includes developing rings, with developing rings respectively provided on the first connecting tube 3 and the second connecting tube 5.

[0041] The balloon 1 is positioned between the first connecting tube 3 and the second connecting tube 5. Therefore, the imaging rings on the first connecting tube 3 and the second connecting tube 5 can track the precise position of the balloon 1 during the operation, enabling real-time visual monitoring of the balloon 1 expansion process. The imaging rings can be made of platinum-based alloys, cobalt-based alloys, or other metal materials that can be visualized under X-rays.

[0042] As one possible implementation, balloon 1 can be a notched balloon, a mastoid balloon, a drug-loaded balloon, etc.

[0043] As one possible implementation, it also includes a head end 9 and a safety wire 10, with the head end 9 connected to the other end of the core wire 7 and the safety wire 10 welded to the head end 9.

[0044] Safety wire 10 is woven from three strands of wire in a braided structure. This multi-strand braided structure significantly improves tensile strength while maintaining good flexibility. It has little impact on the hardness of the head end 9. The point-to-point connection method can improve the overall torsional control of the guide wire. Optionally, the bending function can be achieved by adding a whole section of wire, that is, one end of the wire is pulled and the other end is bent under force, which greatly improves the operation performance of the guide wire.

[0045] Optionally, the air inlet end of the hollow tube 4 is threaded and ground, and a connector is installed. One end of the connector is connected to the guidewire, and the other end is connected to the balloon pressure pump. The connector is installed before pre-dilation begins to connect the balloon pressure pump and dilate the balloon 1. After the balloon 1 is pre-dilated, the connector is removed to facilitate the entry of other instruments along the guidewire into the lesion location.

[0046] The working principle of this utility model is as follows:

[0047] After the guidewire successfully passes through the lesion, the balloon is pushed to accurately position itself at the target lesion. The balloon is then connected to the guidewire using a balloon pressure pump to inflate the balloon and pre-dilate the lesion. After pre-dilation, the pressure is released, and the outer diameter of the balloon is reduced to match the outer diameter of the guidewire, allowing treatment devices such as stents to pass smoothly through the guidewire and enter the lesion.

[0048] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0049] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions, and alterations to the above embodiments within the scope of the present invention without departing from the principles and spirit of the present invention. The scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A pre-dilation guidewire, characterized in that, It includes a balloon, a first cutting sodium thiosulfate tube, a first connecting tube, and a hollow tube. The air inlet of the balloon is sealed to the air outlet of the first connecting tube, and the air inlet of the first connecting tube is sealed to the air outlet of the hollow tube. One end of the first cutting sodium thiosulfate tube passes through the first connecting tube along the axial direction of the first connecting tube.

2. A pre-dilation guidewire as in claim 1, wherein, It also includes a second connecting tube, and the balloon is further provided with an open end. The open end of the balloon is sealed to one end of the second connecting tube, the other end of the second connecting tube is sealed, and the other end of the first cutting sodium thiosulfate tube is inserted into the second connecting tube.

3. A pre-dilation guidewire as in claim 2, wherein, It also includes a spring and a core wire, the spring being connected to the second connecting tube, and one end of the core wire passing through the spring and inserted into the other end of the first cutting sodium thiosulfate tube.

4. A pre-dilation guidewire as in claim 2, wherein, The balloon is an eccentric balloon, which includes an asymmetrically arranged expansion portion. The first cut-thickness tube has a slot, and the expansion portion of the eccentric balloon is located within the slot of the first cut-thickness tube.

5. A pre-dilation guidewire as in claim 1, wherein, The hollow tube is replaced by a second cut thiocyanate tube, the outer diameter of which is larger than that of the first cut thiocyanate tube.

6. A pre-dilation guidewire as in claim 3, wherein, It also includes an inner spring, which is sleeved on the outside of the core wire.

7. A pre-dilation guidewire as in claim 2, wherein, It also includes developing rings, which are respectively provided on the first connecting tube and the second connecting tube.

8. A pre-dilation guidewire as in claim 1, wherein, The balloon is a notched balloon, a mastoid balloon, or a drug-loaded balloon.

9. A pre-dilation guidewire as in claim 3, wherein, It also includes a head end and a safety wire, the head end being connected to the other end of the core wire, and the safety wire being welded to the head end.

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