NON-VASCULAR LUMEN GUIDE WIRE

Abstract

A non-vascular lumen guide wire, comprising a mandrel (1) and a ball head (2) prepared with a metal material, wherein an outer diameter of the insertion end of the mandrel (1) is smaller than the outer diameter of the non-insertion end of the mandrel; the insertion end of the mandrel (1) is connected to the ball head (2), a plastic coating layer (3) is wrapped around the outer side of the mandrel (1), the outer diameter of the ball head (2) is larger than the outer diameter of the insertion end of the plastic coating layer (3), and the outer diameter of the ball head (2) is not larger than the non-insertion end of the plastic coating layer (3). The guide wire, by means of using a ball head (2) with a diameter slightly larger than the plastic coating layer (3) at a far end, may effectively avoid the defects that the guide wire falls off in actual use, or the plastic coating layer (3) at the far end easily rolls up when inserted. The ball head (2) is made of metal material, has a relatively large outer diameter, and has great visibility under an endoscope and an X-ray. A doctor may clearly observe a puncture area reached by the tip end of the guide wire, and the effect of avoiding a guide wire end from puncturing an inner wall of lumens may be realized without the need for a positioning device.

Claims

1. A non-vascular lumen guide wire, comprising: a mandrel and a ball head prepared from a metal material, wherein the outer diameter of the insertion end of the mandrel is smaller than the outer diameter of the non-insertion end of the mandrel, the insertion end of the mandrel is connected to the ball head, a plastic coating layer is wrapped around the outer side of the mandrel, the outer diameter of the ball head is larger than the outer diameter of the insertion end of the plastic coating layer, and the outer diameter of the ball head is not larger than the non-insertion end of the plastic coating layer.

2. The non-vascular lumen guide wire as claimed in claim 1, wherein the outer diameter of the ball head is 1.1 to 3 times the outer diameter of the insertion end of the plastic coating layer.

3. The non-vascular lumen guide wire as claimed in claim 1, wherein the plastic coating layer is coated with a super-slippery hydrophilic coating.

4. The non-vascular lumen guide wire as claimed in claim 1, wherein the plastic coating layer is sleeved outside the mandrel, and the plastic coating layer is made of one or more materials selected from polytetrafluoroethylene, polyurethane or nylon elastomer.

5. The non-vascular lumen guide wire as claimed in claim 1, wherein the plastic coating layer is sleeved outside the mandrel, the plastic coating layer is formed by a first plastic coating layer adjacent to the ball head and a second plastic coating layer far away from the ball head, and the hardness of the second plastic coating layer is greater than that of the first plastic coating layer.

6. The non-vascular lumen guide wire as claimed in claim 5, wherein the first plastic layer has a Shore hardness A of 30 to 90, and the second plastic layer has a Shore hardness D of 50 to 100.

7. The non-vascular lumen guide wire as claimed in claim 5, wherein the first plastic coating layer is made of a material selected from polytetrafluoroethylene, polyurethane or nylon elastomer.

8. The non-vascular lumen guide wire as claimed in claim 5, wherein the second plastic coating layer is made of a material from polytetrafluoroethylene or polyurethane.

9. The non-vascular lumen guide wire as claimed in claim 5, wherein the mandrel and the ball head are made of Nitinol material or stainless steel material.

10. The non-vascular lumen guide wire as claimed in claim 5, wherein the ball head is seamlessly coupled to the mandrel.

11. The non-vascular lumen guide wire as claimed in claim 5, wherein the guide wire is a straight guide wire or an elbow guide wire.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments:

[0025] FIG. 1 is a schematic cross-sectional view of a straight guide wire according to Embodiment 1 of the present invention;

[0026] FIG. 2 is a schematic cross-sectional view of a straight guide wire according to Embodiment 2 of the present invention;

[0027] FIG. 3 is a schematic cross-sectional view of an elbow guide wire provided by the present invention;

[0028] FIG. 4 is a schematic cross-sectional view of a zebra guide wire of Comparative Example 1;

[0029] FIG. 5 is a schematic cross-sectional view of a hybrid guide wire of Comparative Example 2.

[0030] The component numbers are as follows: [0031] 1mandrel [0032] 2Ball head [0033] 3plastic coating layer [0034] 31First plastic coating layer [0035] 32Second plastic coating layer

DETAILED DESCRIPTION OF THE INVENTION

[0036] Preferred embodiments of the present invention will now be described in detail in conjunction with the drawings. Although the description of the present invention will be described in conjunction with the various embodiments, it is not intended that the features of the invention are limited to the embodiments. Rather, the invention is described in connection with the embodiments so as to cover other alternatives or modifications that are possible in the embodiments of the invention. In order to provide a thorough understanding of the present invention, many specific details are included in the following description. The invention may also be practiced without these details. In addition, some specific details are omitted from the description in order to avoid confusion or blur the focus of the present invention.

[0037] In addition, upper, lower, left, right, top, and bottom used in the following description are set to better describe the preferred embodiment of the present invention. It should not be construed as limiting the invention.

[0038] As used herein, the term proximal end or tail end of a guide wire is the guide wire segment that extends closest to the doctor on the outside of the body, that is, the non-insertion end. The distal end or front end of the guide wire is the guide wire section furthest from the inlet part within the body lumens, that is, the insertion end.

[0039] In the following drawings, the full length of the guide wire is not shown. The length of the guide wire can be changed according to the type of interventional surgery, but typically the length of the guide wire is in the range of 30 to 800 centimeters (cm). The common length of the guide wire for the intervention of the coronary, peripheral, and neural vessels may range from 170 to 300 cm.

EMBODIMENT

[0040] The technical solution of the present invention is as shown in FIG. 1. The non-vascular lumen guide wire provided by the present invention comprises a mandrel 1 and a ball head 2 prepared from a metal material, and an outer diameter of the insertion end of the mandrel 1 is smaller than an outer diameter of the non-insertion end of the mandrel 1. The insertion end of the mandrel 1 is connected with the ball head 2, and a plastic coating layer 3 is wrapped around the outer side of the mandrel 1. The outer diameter of the ball head 2 is larger than the outer diameter of the insertion end of the plastic coating layer 3. The outer diameter of the ball head 2 is not larger than the non-insertion end of the plastic coating layer 3. Since the diameter of the ball head 2 is slightly larger than the outer diameter of the insertion end of the plastic coating layer 3, it is possible to effectively prevent the plastic coating layer 3 in the guide wire from falling off during actual use, or prevent the defect that the insertion end of the plastic coating layer 3 is easily rolled up during the insertion process. The outer diameter of the ball head 2 needs to be no larger than the outer diameter of the non-insertion end of the plastic coating layer 3, thereby avoiding requiring more larger size instrument passage due to the excessively large size of the guide wire head. The guide wire head has a spherical head shape with a smooth appearance, and is not easy to stab the inner wall of the lumens; and The guide wire head has a diameter larger than the outer diameter of the insertion end of the plastic coating layer 3, and the size is larger than the guide wire head of the prior art. The ball head 2 can be clearly observed under the endoscope and the X-ray based on the excellent developability of the metal itself, and the doctor can clearly observe the insertion situation of the guide wire, and can prevent the guide wire from piercing the inner wall of the lumens without the positioning device.

[0041] Further, the person skilled in the art can adjust the size of the ball head 2 according to actual needs. For example, the outer diameter of the ball head 2 can be preferably 1.1 to 3 times the outer diameter of the insertion section of the plastic coating layer 3. If the size of the ball head 2 is too small, and the visibility under the X-ray machine and the endoscope is weakened. Therefore, even if the guide wire head is in the shape of a ball, the area of the force when it contacts the inner wall of the lumens is still small. If the operator cannot clearly observe the position of the guide wire head, the inner wall may be stabbed once the operator is careless. If the size of the ball head 2 is too large, the insertion resistance is increased, which may increase the difficulty of insertion of the guide wire.

[0042] Further, the plastic coating layer 3 is coated with a super-slippery hydrophilic coating. The super-slippery hydrophilic coating can adsorb and retain the liquid, so that the friction resistance of the guide wire surface is reduced, and the insertion performance of the guide wire is further increased.

[0043] Further, the plastic coating layer 3 is a plastic sleeve set outside the mandrel. The plastic coating layer 3 can be selected from materials with good flexibility (such as soft materials, elastic materials, etc.). The specific materials do not have a special qualification, can be selected from polyolefins such as polyethylene and polypropylene, polyvinyl chloride, polyester (PET, PBT, etc.), polyamide, polyimide, polyurethane, polystyrene, polycarbonate, silicone resin, fluoropolymer (PTFE, ETFE, PFA, etc.), composite materials of these materials, or one or more of various rubber materials selected from latex rubber, silicone rubber, nylon elastomer and the like.

[0044] Further, the plastic coating layer 3 is most preferably made of one or more materials of polytetrafluoroethylene, polyurethane or nylon elastomer; the polytetrafluoroethylene material has low surface friction and good lubricity, and can improve the insertion of guide wire; polyurethane material and nylon elastomer are highly biocompatible, which can reduce the stimulation of the guide wire on the inner wall tissue of the lumens.

[0045] Preferably, as shown in FIG. 2, the plastic coating layer 3 is sleeved outside the mandrel, and the plastic coating layer 3 is composed of a first plastic coating layer 31 adjacent to the ball head 2 and a second plastic coating layer 32 far away from the ball head. The hardness of the second plastic coating layer 32 is greater than that of the first plastic coating layer 31. The presence of the plastic coating layer 3 is mainly for increasing the biocompatibility of the guide wire and the inner wall of the lumens, or for lubricating and reducing the resistance when the guide wire is inserted. At the same time, the flexibility and bendability of the mandrel may be lowered due to the presence of the plastic coating layer 3. However, the flexibility and bendability of the guide wire head can be improved and the guiding performance in a relatively complicated lumens is facilitated by making one end near the ball head 2 as the softer first plastic coating layer 31. Moreover, the first plastic coating layer 31 is softer, which can further prevent the ball head 2 from stabbing the inner wall of the lumens. The strength of the guide wire can be ensured and the insertion performance can be improved by setting the end away from the ball head 2 to the harder second plastic coating layer 32. Preferably, the first plastic coating layer 31 has a Shore hardness A of 30 to 90, and the second plastic coating layer 32 has a Shore hardness D of 50 to 100. The Shore hardness of the first plastic coating layer 31 and the second plastic coating layer 32 is within this range, so that, the stab resistance of the ball guide wire can be further improved, and the insertion performance of the ball guide wire can be sufficiently ensured.

[0046] More preferably, the first plastic coating layer 31 is made of a material with a lower hardness selected from a polytetrafluoroethylene, polyurethane or nylon elastomer. More preferably the first plastic coating layer 31 is made of a polyurethane material, the polyurethane has high strength, good biocompatibility with human bodies and high flexibility at human temperature. The flexibility of the tip end portion of the guide wire is further improved when the first plastic coating layer 31 is mainly composed of polyurethane resins, so that the inner wall of the lumens can be more reliably prevented from being damaged and the safety of operation is improved when the catheter is inserted into the lumens. The second plastic coating layer 32 is made of polytetrafluoroethylene or polyurethane material with a high hardness. The polytetrafluoroethylene is preferable, which has high strength, low surface friction and good lubricity, and can improve the insertion performance of the guide wire.

[0047] Further, the mandrel 1 is made of a metal material, and for example, various metal materials such as stainless steel and pseudo-elastic alloys (including ultra-elastic alloys), and other metal materials. The nickel titanium alloy material is preferable.

[0048] The constituent material of the mandrel 1 in the guide wire is made of a metal material, and is not particularly limited, which is common in the art can be selected. For example, stainless steel (e.g. SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS429, SUS430F, SUS302 and other), pseudo-elastic alloy (including) and other various metal materials can be used, and an ultra-elastic alloy is preferable. Since the ultra-elastic alloy is relatively soft and resilient, the guide wire with the mandrel made of the ultra-elastic alloy has a sufficient bending softness and elastic recovery capability at the front end portion thereof, which can improve the insertion performance for the complicated and curved lumens, and can obtain more excellent operability. The guide wire does not cause permanent bending deformation due to the excellent elastic recovery ability of the guide wire even if the guide wire undergoes repeated bending deformation, so that the situation that the occurrence of bending causes a decrease in operability can be avoided when the guide wire is in use.

[0049] Further, the ultra-elastic alloy is preferably a nickel-titanium alloy. The guide wire using the nickel-titanium alloy as the mandrel has excellent push performance and torque transmission performance, and then has good operability with the distal end has a good softness and resilience, and then the following performance and safety for the lumens are improved, further reducing the risk of piercing the inner wall of the lumens.

[0050] Further, the ball head 2 is seamlessly coupled to the mandrel, and the ball head 2 is preferably integrally formed with the mandrel 1 and seamlessly coupled to the mandrel 1, which reduce the risk of falling off of the ball head 2.

[0051] The ball head 2 may be coated with a functional coating such as one or more of a hydrophilic coating, a hydrophobic coating or a bioactive coating. The hydrophilic coating may attract water molecules to form a gel surface on the surface thereof, which can reduce the passing resistance of the guide wire. The hydrophilic coating material is not specifically limited, and the coating is preferably formed of a material having a small frictional resistance. For example, it is preferably made of polyvinyl alcohol, polyvinylpyrrolidone, polyethylene glycol, polyacrylamide, polyacrylic acid, sodium polyacrylate, poly (2-hydroxyethyl methacrylate), maleic anhydride copolymer, ethylene-vinyl alcohol Copolymer, 2-methacryloyloxyethylphosphocholine or its copolymer, (2-hydroxyethyl methacrylate)-styrene block copolymer, various synthetic peptides, collagen, hyaluronate, or one or more of cellulose-based copolymers.

[0052] The ball head 2 may also be coated with a hydrophobic coating. The hydrophobic coating material is not particularly limited, and one or more of silicone, polytetrafluoroethylene or fluorinated ethylene propylene copolymer may be used. The hydrophobic coating layer can inhibit the formation of waxy surface of water molecules, reduce friction and increase the tracking performance of the guide wire.

[0053] Further, the above-mentioned functional coating layer may also be coated on the plastic coating layer 3 depending on the cost.

[0054] Further, the guide wire can be a straight guide wire or an elbow guide wire. The straight guide wire is widely used and is suitable for most percutaneous cannula insertion operations. As shown in FIG. 3, the guide wire in the present invention can also be an elbow guide wire, and the front end of the elbow guide wire is curved, the advantage of which is that the front end of the guide wire does not protrude on the inner wall of the lumens when the catheter encounters a curved and deformed lumen, further effective to prevent damage to the inner wall of the lumens.

[0055] Further, the plastic coating layer 3 may be provided with a marking portion, which can further improve the visibility of the guide wire under the endoscope, and to further avoid stabbing the inner wall of the lumens combining with the ball head 2.

[0056] The structure of the above-mentioned marking portion is not particularly limited as long as it is observed under an endoscope or an X-ray machine, and the marking portion may be an alternating spiral stripe of two or more colors, alternating rings or alternating Vertical stripes. The insertion situation of the guide wire can be clearly seen under the endoscope by distinct contrasting colors at intervals.

[0057] Further, the alternating spiral stripe may be black and white stripes, black and blue stripes, black and green stripes, yellow and green stripes, black and red stripes, red and green stripes, red and blue stripes, or black and yellow stripes, etc., but is not specifically limited, which is selected by a distinct color contrast and easy observation of the endoscope.

[0058] The marking portion may also be an X-ray development marking ring, a point, a line, etc., which is disposed near the distal end of the guide wire to further ensure the visibility of the guide wire under the X-ray machine, facilitate the operation of the doctor, and effectively prevent the guide wire from piercing the inner wall of the lumens.

[0059] In order to further demonstrate the technical effects of the present invention, the following content will be further described with reference to the embodiments:

Embodiment 1

[0060] According to the ball zebra guide wire as shown in FIG. 1, the mandrel 1 and the ball head 2 is made of a metal material, the plastic coating layer 3 has a Shore hardness D of 60, the ball head 2 has a size of 0.7 mm. The outer diameter of the insertion end of the plastic coating layer 3 is 0.35 mm, and the non-insertion end of the plastic coating layer 3 is 0.89 mm.

Embodiment 2

[0061] The ball-head mixing guide wire as shown in FIG. 2 is different from Embodiment 1 only in that the plastic coating layer 3 includes a first plastic coating layer 31 and a second plastic coating layer 32, the first plastic coating layer 31 has a Shore hardness A of 75, and the second plastic layer 32 has a Shore hardness D of 60.

Comparative Example 1

[0062] The zebra guide wire as shown in FIG. 4 is different from Embodiment 1 only in that it does not contain the ball head 2, the insertion end of the mandrel 1 is completely covered by the plastic coating layer 3, and the outer diameter of the insertion end of the guide wire is 0.35 mm.

Comparative Example 2

[0063] The mixed guide wire as shown in FIG. 5 is different from Embodiment 1 only in that it does not contain the ball Head 2, the insertion end of the mandrel 1 is completely covered by the first plastic coating layer 31, and the outer diameter of the insertion end of the guide wire is 0.35 mm.

Test Methods

[0064] The guide wire was clamped using a microcomputer-controlled electronic universal testing machine. The guide wire was passed through a plastic tube with an inner diameter of 1.67 mm (5F), and pierces an aluminum foil (aluminum foil thickness 0.07 mm) at a speed of 3 inches/min and a 90 degree angle. The force required by the tip to pierce the aluminum foil is recorded. The test is repeated 5 times to take the average.

Experiment Apparatus

[0065] 1. Microcomputer control electronic universal testing machine, purchased from Shanghai Hualong Testing Instrument Co., Ltd., model: WDW-5;
2. Plastic pipe, purchased from Shanghai Yanke Precision Extrusion Technology Co., Ltd., model: 1.67 mm (5F);
3. Aluminum foil, purchased from Shanghai Shenhuo Aluminum Foil Co., Ltd., model: thickness is 0.07 mm.

[0066] The experimental results of Embodiments 1-2 and Comparative Examples 1-2 are shown in Table 1 below:

TABLE-US-00001 Comparative Comparative Embodiment 1 Embodiment 2 example 1 example 2 Ball Head Ball Head Zebra Guide Mixed Guide Zebra Mixed Wire Wire Guide Wire Guide wire 0.352N 0.562N 0.169N 0.221N

[0067] It can be seen from Example 1 and Comparative Example 1 that the force required for the ball zebra guide wire to pierce the aluminum foil is significantly increased, that is, the performance of stab-resistant against the lumens of the ball guide wire has been greatly improved.

[0068] Further, in Embodiment 2, the plastic coating layer is divided into the softer first plastic coating layer and the harder second plastic coating layer, so that, the end near the ball head of the guide wire is more flexible, the force required for the guide wire to pierce the aluminum foil is increased to 0.562N, which further improves the performance of the stab resistance of the guide wire. The guide wire of the present invention can be used in any interventional, diagnostic, and/or therapeutic procedure, including directing other devices, such as catheters, stents, and/or balloons, to a target area of a patient, and the like.

[0069] The outer diameter of the ball head in the guide wire according to the invention is larger than the outer diameter of the plastic coating layer, which can effectively prevent the guide wire from falling off during the actual use, or overcome the defect that the distal end of the plastic coating layer is easy to be rolled up during the insertion process. The mandrel and the ball head of the guide wire are made of a metal material, the developability of which under the X-ray machine is much better than that of the plastic, and the outer diameter of the ball head is slightly larger than the plastic coating layer, so that the ball head can be Obviously observed by the X-ray machine and the endoscope, and the doctor can clearly observe the puncture site reached by the tip end of the guide wire. Therefore, the effect of preventing the guide wire head from piercing the inner wall of the lumens can be achieved without a positioning device.

[0070] The above description of the embodiments of the present invention is intended to illustrate the invention of the present invention, and is not intended to limit the scope of the claims. The above-described embodiments can be easily modified and modified by those skilled in the art in light of the inventive concept of the invention, and the modifications and modifications within the scope of the invention are included in the scope of the attached claims.