Multifunctional superhard guide wire and catheter kit comprising same

Abstract

The invention belongs to the field of medical guide wires, and particularly relates to a multifunctional superhard guide wire and a catheter kit containing the guide wire. The superhard guide wire body is a core wire and is sequentially divided into a head spring winding section, a middle pushing section and a tail contact section from front to back, and the multifunctional catheter kit comprises a sheathing canal, a catheter base, a first three-way valve, a hose, a second three-way valve and a pressure meter. A guide tube is arranged at the front end of the sheath tube; the catheter seat comprises a main tube and a side tube; the front end of the main tube is connected with the rear end of the sheath tube; the rear end of the hose is connected with a pressure gauge through a second three-way valve; according to the method, the total operation amount of various types of operations such as TAVR, TEAVR and EVAR can be effectively reduced, the operation time is shortened, and the use requirements of medical materials and medical equipment are reduced.

Description

Technical Field

[0001] The invention belongs to the field of medical guide wires, and in particular relates to a multifunctional superhard guide wire and a catheter kit containing the guide wire. Background Art

[0002] Before the invention of TAVR surgery, patients with calcified aortic stenosis could only be treated with heavy surgery, but more than half of patients were unable to undergo heavy surgery due to adverse factors such as advanced age and physical exhaustion, which limited their life expectancy. In 2002, Alain Cribier, a well-known French cardiovascular expert, successfully performed the first transcatheter aortic valve replacement (TAVR). Since then, transcatheter aortic valve replacement (TAVR) has become an effective treatment for valvular disease and has effectively improved patients' survival expectations.

[0003] Thoracic endovascular aortic repair (TEVAR) and abdominal endovascular aneurysm repair (EVAR) are designed for patients who are elderly or have complications and cannot withstand traditional surgical treatment. By implanting a covered stent, the entrance of the dissection tear can be blocked, the true lumen can be expanded, the false lumen can be eliminated, the aorta can be prevented from dilatation and rupture, and the blood supply to distal organs and tissues can be improved. In the treatment of aortic disease and valvular disease, the outer diameter of the stent and valve system delivery system is larger and heavier than other treatment devices. The stable delivery and precise release of the device in the body puts higher requirements on the performance of the guidewire.

[0004] At present, when performing the above-mentioned operations in domestic hospitals, temporary pacing wires are almost always inserted into the right ventricle through a peripheral vein. The ventricle is rapidly paced during balloon dilation and valve release in the left ventricle to reduce the impact of blood flow on the device and ensure the stability of the device. Generally, temporary pacing wires are routinely left in place for 24 hours after surgery to deal with possible conduction blocks and bradycardia. This method not only has a long operation time, but also has a high risk of puncture complications and right ventricular perforation. If it is necessary to monitor the pressure in the aorta during the operation, an additional pressure monitoring catheter needs to be implanted, which further increases the surgical steps, time and surgical risks. Summary of the invention

[0005] The object of the present invention is to provide a multifunctional superhard guide wire and a catheter kit containing the guide wire.

[0006] To achieve the above purpose, the present invention adopts the following technical solution.

[0007] A multifunctional superhard guide wire, the main body of the superhard guide wire 8 is a core wire, which is divided into a head spring winding section, a middle pushing section 81, and a tail contact section 82 from front to back;

[0008] The middle push section 81 is 2000-3000 mm long and is provided with a PTFE coating on the outside;

[0009] The tail contact section 82 has a length of 20 to 100 mm and a bare surface without coating;

[0010] The length of the head spring winding section is 100 to 200 mm, and it is a multi-layer structure, including a core wire cone 800 and a double-layer spring 801 wrapped around the core wire cone 800;

[0011] The core wire cone 800 is a conical cylinder formed by grinding the front end of the core wire in one piece;

[0012] The double-layer spring 801 includes an inner flat wire spring 801a made of gold and an outer flat wire spring 801b made of stainless steel; the inner flat wire spring 801b is wound around the outside of the tip of the core wire cone 800, with a winding interval length of 20mm to 60mm; the outer flat wire spring 801a is wound around the outside of the inner flat wire spring 801b and the core wire cone 800, with a winding interval length of 150mm to 300mm; the surfaces of the outer flat wire spring 801a and the inner flat wire spring 801b are exposed and uncoated.

[0013] A further improvement or preferred embodiment of the aforementioned multifunctional superhard guide wire, wherein the core wire is made of 304V stainless steel wire;

[0014] The tensile strength of the core wire taper is 2000-2200MPa, and the peak bending pressure at three points with a span of 40mm is not less than 20N;

[0015] The outer flat wire spring 801a refers to a stainless steel flat wire spring with a size of 0.08mm*0.25mm; the inner flat wire spring 801b refers to a gold flat wire spring with a size of 0.08mm*0.08mm;

[0016] A further improvement or preferred implementation of the aforementioned multifunctional superhard guide wire, wherein the superhard guide wire 8 has a diameter of 0.89±0.05mm, a head spring section length of 150±5mm, an inner flat wire spring 801b winding section length of 40±3mm, an outer flat wire spring 801a winding section length of 150±5mm, a tail contact section 82 length of 35±3mm, and an overall length of the tail contact section 82 and the middle pushing section 81 of 2457±10mm.

[0017] As a further improvement or preferred embodiment of the aforementioned multifunctional superhard guidewire, the head spring-wound section is a straight structure or an arc structure, and the arc structure is divided into a first spiral section and a straight section from far to near from the middle pushing section 81 .

[0018] As a further improvement or preferred embodiment of the aforementioned multifunctional superhard guide wire, one end of the middle pushing section 81 close to the head spring winding section is integrally ground with the inner core 800 to form a smooth transition section 810 .

[0019] A further improvement or preferred implementation of the aforementioned multifunctional superhard guide wire is that the head spring winding section is a spiral curve structure.

[0020] A further improvement or preferred embodiment of the aforementioned multifunctional superhard guidewire is that the head spring winding section is composed of multiple horizontal and vertical spiral sections, and the diameters of the spiral sections decrease successively. From far to near from the middle pushing section, the preferred sizes are as follows:

[0021]

[0022] The blank space in the table indicates that the corresponding segment does not exist.

[0023] The superhard guide wire provided by the present invention has the following characteristics:

[0024] A. Multifunctional features: It has high support and soft head end, and the bend can be adjusted according to needs to meet the needs of different surgeries such as transcatheter aortic valve replacement (TAVR), thoracic endovascular aortic repair (TEVAR), and abdominal endovascular aortic repair (EVAR). It can also be used to achieve pacing function during surgeries such as aortic valve delivery and positioning.

[0025] B. More friendly features: Traditional aortic valve replacement surgery requires additional femoral vein access and implantation of a temporary pacing electrode to pace the heart. The super-hard guidewire based on this application does not require additional implantation of a temporary pacing electrode, reducing invasive operations, simplifying the operation process, reducing the difficulty of operation, and being more friendly to both doctors and patients;

[0026] C. More economical: No special pacing guidewire and corresponding operation are required, which reduces the economic burden on patients and reduces the consumption of medical resources;

[0027] D. Excellent operability: The special grinding and winding structure of the head spring section can effectively ensure its softness and toughness, improve safety, and have excellent conductivity to ensure the pacing effect; the middle push section is provided with PTFE coating to effectively prevent damage to blood vessels, and the front transition section ensures that the overall size of the guidewire is smooth and consistent; the tail contact section can be directly connected to the electrodes of temporary pacemakers and other equipment, effectively reducing the difficulty of operation.

[0028] The present application also relates to a catheter kit containing a multifunctional superhard guidewire, comprising a sheath tube 1, a catheter seat 2, a first three-way valve 3, a hose 4, a second three-way valve 5, and a pressure gauge 6 connected in sequence;

[0029] The front end tube opening 1a of the sheath tube 1 is an oblique cut, and a guide tube 10 is provided on the outer side of the tube wall where the tip of the oblique cut is located;

[0030] The catheter seat 2 includes a main valve tube 20 and a side valve tube 21; the front end of the main valve tube 20 is connected to the rear end of the sheath tube 1, and the side valve tube 21 is connected to the main valve tube 20 and is connected to the front end of the hose 4 through the first three-way valve 3;

[0031] The rear end of the hose 4 is connected to the pressure gauge 6 through the second three-way valve 5.

[0032] The head spring section of the superhard guide wire 8 is inserted into the guide tube 10 .

[0033] As a further improvement or preferred embodiment of the aforementioned catheter kit containing a multifunctional superhard guidewire, the rear end of the guide tube 10 is provided with an oblique cut; the guide tube 10 extends forward and exceeds the front edge of the front end tube opening 1a of the sheath tube 1, or is flush therewith.

[0034] A further improvement or preferred embodiment of the aforementioned catheter kit containing a multifunctional superhard guidewire further includes a pressure gauge data cable 7 and a data plug 9 connected to the pressure gauge 6 .

[0035] The catheter kit provided by the present invention has the following characteristics:

[0036] A. Multifunctional features: During the aortic valve delivery and positioning process for TAVR surgery, hemodynamic measurement can be achieved simultaneously without the need for additional medical devices;

[0037] B. Economic benefits: No additional blood pressure monitoring equipment is required, and the use of dedicated pacing guidewires and corresponding surgical operations are avoided, which reduces the demand for equipment and guidewires, helps to reduce the economic burden on patients and reduce the consumption of medical resources;

[0038] C. Easy to use: Based on the structure of the catheter kit, only one guidewire needs to be inserted, and the guidewire can be inserted repeatedly later. When the catheter is not needed, it can be quickly withdrawn without pulling out the guidewire. It is more convenient to introduce other instruments into the vascular access, while reducing the amount of surgical operations, shortening the operation time, reducing the incidence of complications, simplifying the surgical process, and reducing the difficulty of the operation; BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 It is a schematic diagram of a multifunctional superhard guide wire;

[0040] Figure 2 It is a schematic diagram of the partial structure of the head spring section of the multifunctional superhard guide wire;

[0041] Figure 3 Schematic diagram of the shape of the spring-wound section at the front end of the superhard guide wire in the second embodiment;

[0042] Figure 4 It is a schematic diagram of the front end head spring section of part of the superhard guide wire in the third embodiment, which is applicable to the left ventricle;

[0043] Figure 5 It is a schematic diagram of the front end head winding spring section of part of the superhard guide wire in Example 3, which is applicable to the aorta;

[0044] Figure 6 is a schematic diagram of the structure of the catheter kit;

[0045] Figure 7 is a partial schematic diagram of the catheter kit;

[0046] Figure 8 is a partial cross-sectional view of the catheter kit;

[0047] The reference numerals include:

[0048] Sheath 1, front end tube mouth 1a, guide tube 10, catheter seat 2, main tube 20, side tube 21, first three-way valve 3, hose 4, second three-way valve 5, pressure gauge 6, pressure gauge data cable 7, superhard guide wire 8, head spring section 80, core wire cone 800, double-layer spring 801, inner flat wire spring 801a, outer flat wire spring 801b, middle push section 81, tail contact section 82, data plug 9. DETAILED DESCRIPTION

[0049] The present application provides a super-hard guidewire and a catheter kit thereof, based on which the application requirements of various surgeries such as transcatheter aortic valve replacement (TAVR), thoracic endovascular aortic repair (TEAVR), and abdominal endovascular aortic repair (EVAR) can be met, and the pacing function can also be achieved at the same time. Further combined with the catheter kit, the guidewire can be inserted once, and the catheter can be quickly withdrawn and replaced. The catheter can be withdrawn without withdrawing the guidewire or reinserting the guidewire, and the super-hard guidewire can be used to pace the left ventricle and other functions while the valve is installed.

[0050] There are currently a variety of rigid guidewires and pressure monitoring catheter products in China, but they all have a single function and can only achieve aortic valve delivery positioning or blood flow pressure monitoring. When both are needed, two independent catheters are used for multiple insertions, which prolongs the operation time, increases the operation content, and increases the total amount of indwelling objects in the body.

[0051] Based on the catheter kit structure provided by the present invention, while being used for the delivery positioning function, it can also continuously realize real-time intravascular blood flow pressure monitoring, so that the two can be performed synchronously, ensuring complete monitoring during the operation, and timely identifying the risks that may be encountered during the operation. In conjunction with the superhard guidewire provided by the present application, when switching catheters with different functions, the disadvantages of the conventional solution of withdrawing the guidewire and catheter at the same time and reinserting the guidewire and guiding catheter can be avoided, and the right ventricular pacing operation can be completed at the same time. The combination of the two can effectively reduce the operation volume of TAVR surgery, shorten the operation time, and reduce the demand for the use of medical materials and medical equipment, and there are great improvements in economy and friendliness between doctors and patients.

[0052] like Figure 1 , Figure 2 As shown, the main body of the multifunctional superhard guide wire 8 of the present application is a core wire, which is divided into a head spring winding section, a middle pushing section 81, and a tail contact section 82 from front to back;

[0053] The middle push section 81 is 2000-3000 mm long and is provided with a PTFE coating on the outside;

[0054] The tail contact section 82 has a length of 20 to 100 mm and a bare surface without coating;

[0055] The length of the head spring winding section is 100 to 200 mm, and it is a multi-layer structure, including a core wire cone 800 and a double-layer spring 801 wrapped around the core wire cone 800;

[0056] The core wire cone 800 is a conical cylinder formed by grinding the front end of the core wire in one piece;

[0057] The double-layer spring 801 includes an inner flat wire spring 801a made of gold and an outer flat wire spring 801b made of stainless steel; the inner flat wire spring 801b is wound around the outside of the tip of the core wire cone 800, with a winding interval length of 20mm to 60mm; the outer flat wire spring 801a is wound around the outside of the inner flat wire spring 801b and the core wire cone 800, with a winding interval length of 150mm to 300mm; the surfaces of the outer flat wire spring 801a and the inner flat wire spring 801b are exposed and uncoated.

[0058] On the basis of the basic structure, in order to optimize the guide wire performance, in this embodiment, the core wire adopts 304V stainless steel wire; the tensile strength of the core wire is 2000-2200MPa, and the peak bending pressure of three points with a span of 50mm is not less than 20N; the outer flat wire spring 801a refers to a stainless steel flat wire spring with a size of 0.08mm*0.25mm; the inner flat wire spring 801b refers to a gold flat wire spring with a size of 0.08mm*0.08mm;

[0059] The diameter of the superhard guide wire 8 is set to 0.89±0.05mm, the covering interval length of the double-layer spring is 40±3mm, the head spring section length is 150±5mm, among which the winding interval length of the inner flat wire spring 801b is 40±3mm, the winding interval length of the outer flat wire spring 801a is 150±5mm, the tail contact section 82 is 35±3mm, and the overall length of the tail contact section 82 and the middle push section 81 is 2457±10mm; among which the end of the middle push section 81 close to the head spring section is ground integrally with the core wire taper 800 to form a smooth transition section 810.

[0060] The ultra-hard guidewire kit A based on the aforementioned structure can provide high support strength to meet the delivery requirements of large devices such as valves, while the head end is kept soft to effectively protect the heart cavity.

[0061] To further determine the pacing performance of the guidewire, the positive and negative poles of the multimeter were used to clamp the head and tail ends of the guidewire respectively, and the impedance mode was used to measure the guidewire impedance. The results showed that the guidewire with an overall length of 2600±10mm had a resistance of no higher than 3.5 ohms and an impedance of no higher than 1.35Ω / m, which fully met the requirements for use as a pacing electrode.

[0062] The specific implementation modes of the present invention are further described below in conjunction with examples.

[0063] Embodiment 1

[0064] A multifunctional superhard guide wire

[0065] On the basis of the basic structure, the head spring section in this embodiment is a straight structure. The superhard guidewire kit C of this specification is more suitable for transcatheter aortic valve replacement. It adopts a general straight and curved structure. Compared with other embodiments, the multifunctional superhard guidewire A of the first embodiment is more flexible in application and has a wide range of application scenarios. According to the actual situation, the clinician can shape the guidewire head end according to the specific surgical type requirements to make it suitable for multiple surgical procedures, including but not limited to:

[0066] 1. Transcatheter aortic valve replacement (TAVR) is used to deliver the aortic valve to the left ventricle. The valve delivery system is large in size. The superhard guidewire in this embodiment has the characteristics of high support and can be used to meet its needs.

[0067] 2. TEVAR, thoracic endovascular aortic repair, is used to deliver thoracic aortic stent systems;

[0068] 3. Endovascular aortic repair (EVAR), etc., used to deliver abdominal aortic stent systems;

[0069] Embodiment 2

[0070] A multifunctional superhard guide wire B

[0071] like Figure 3 As shown, based on the basic structure, the head spring section in this embodiment is an arc structure, and from far to near the middle push section, they are respectively the first spiral section with a horizontal width of D01 and a diameter of R01, and a straight section with a length of L01. The superhard guidewire kit D of this specification is mainly used for thoracic aortic endovascular repair and abdominal aortic endovascular repair. At the same time, clinicians can further shape the guidewire tip according to specific surgical requirements to meet the functional requirements of TAVR surgery or other operations. Compared with embodiment 1, the multifunctional superhard guidewire B of embodiment 2 is more applicable and safer in TEVAR and EVAR.

[0072] It includes the following models

[0073] 1D01=8.08R01=3.6L01=3.96.

[0074] Embodiment 3

[0075] A multifunctional superhard guide wire B

[0076] On the basis of the basic structure, the head spring winding section in this embodiment is a spiral curve structure, which is composed of multiple spiral sections with successively decreasing diameters. From far to near from the middle pushing section, they are respectively a first spiral section with a horizontal width of D1, a second spiral section with a vertical height of D2, a third spiral section with a horizontal width of R3, and a fourth spiral section with a vertical height of D4.....;

[0077] Based on the above structure, several special super-hard guidewire designs suitable for different types of surgeries can be derived, such as Figure 4 , Figure 5 Some of the models and specifications are shown in Table 1:

[0078] Table 1 Different specifications and models

[0079]

[0080] In particular, the 08, 09, and 10 models of ultra-hard guidewires are based on actual needs. In order to better protect the vascular access when the pacing function is not needed, the head spring segment is further improved to a PTFE-coated structure.

[0081] like Figure 6 , Figure 7 , Figure 8 As shown, based on the aforementioned multifunctional superhard guidewire, the present application also provides a catheter kit, the main structure of which includes a sheath tube 1, a catheter seat 2, a first three-way valve 3, a hose 4, a second three-way valve 5, and a pressure gauge 6 connected in sequence;

[0082] The front end tube opening 1a of the sheath tube 1 is an oblique cut, and a guide tube 10 is provided on the outside of the tube wall where the tip of the oblique cut is located; the rear end of the guide tube 10 is set as an oblique cut; the guide tube 10 extends forward and exceeds the leading edge of the front end tube opening 1a of the sheath tube 1, or is flush with it. Based on this structural scheme, in conjunction with the oblique cut, the leading edge can be effectively prevented from damaging the blood vessel, while increasing the contact area between the catheter tube opening and the blood, thereby improving the accuracy of blood flow pressure detection.

[0083] The catheter seat 2 includes a main tube 20 and a side tube 21; the front end of the main tube 20 is connected to the rear end of the sheath tube 1, the side tube 21 is connected to the main tube 20, and is connected to the front end of the hose 4 through the first three-way valve 3; in specific implementation, by setting a hemostatic valve at the rear end of the main tube, blood splashing can be prevented and other instruments such as guidewire catheters can be connected conveniently.

[0084] The rear end of the hose 4 is connected to a pressure gauge 6 via a second three-way valve 5 .

[0085] Also included are a pressure gauge data cable 7 and a data plug 9 connected to the pressure gauge 6 .

[0086] In the present application, through the passage formed by the sheath 1, the first three-way valve 3 and the hose 4, after the sheath enters the ventricle, the pressure gauge can be used to indirectly measure the blood flow pressure in the ventricle by the pressure change in the passage, without relying on additional blood flow pressure monitoring equipment, thereby avoiding secondary implantation operations, minimizing invasive operations, simplifying the operating procedures, reducing the consumption of medical resources, and alleviating the economic burden on patients.

[0087] Among them, the three-way valve structure is conducive to better control of the monitoring process and prevents blood flow from entering one side of the pressure gauge; the data collected by the pressure gauge can be connected to various medical monitoring devices using the pressure gauge data cable 7 and data plug 9, providing a data interface for further monitoring and analysis functions.

[0088] Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solution of the present invention can be modified or replaced by equivalents without departing from the essence and scope of the technical solution of the present invention.

Claims

1. A multifunctional superhard guide wire, characterized in that: The main body of the superhard guide wire (8) is a core wire, which is divided into a head spring winding section (80), a middle pushing section (81), and a tail contact section (82) from front to back; The middle pushing section (81) is 2000-3000 mm long and is provided with a PTFE coating on the outside; The tail contact section (82) has a length of 20 to 100 mm and a bare surface without coating; The head spring winding section (80) has a length of 100 to 200 mm and is a multi-layer structure, comprising a core wire cone (800) and a double-layer spring (801) wrapped around the core wire cone (800); The core wire cone (800) is a conical cylinder formed by integrally grinding the front end of the core wire; The double-layer spring (801) comprises an inner flat wire spring (801a) made of gold and an outer flat wire spring (801b) made of stainless steel; the inner flat wire spring (801b) is wound around the outside of the tip of the core wire cone (800), with a winding interval length of 20 mm to 60 mm; the outer flat wire spring (801a) is wound around the outside of the inner flat wire spring (801b) and the core wire cone (800), with a winding interval length of 150 mm to 300 mm; the surfaces of the outer flat wire spring (801a) and the inner flat wire spring (801b) are exposed and without coating.

2. The multifunctional superhard guide wire according to claim 1, characterized in that: The core wire is 304V stainless steel wire; the tensile strength of the core wire cone is 2000~2200MPa, and the peak bending pressure at three points with a span of 40mm is not less than 20N; the outer flat wire spring (801a) refers to a stainless steel flat wire spring with a size of 0.08mm*0.25mm; the inner flat wire spring (801b) refers to a gold flat wire spring with a size of 0.08mm*0.08mm.

3. The multifunctional superhard guide wire according to claim 1, characterized in that: The diameter of the superhard guide wire (8) is 0.89±0.05 mm, the length of the head spring section (80) is 150±5 mm, the length of the winding section of the inner flat wire spring (801b) is 40±3 mm, the length of the winding section of the outer flat wire spring (801a) is 150±5 mm, the length of the tail contact section (82) is 35±3 mm, and the overall length of the tail contact section (82) and the middle pushing section (81) is 2457±10 mm.

4. The multifunctional superhard guide wire according to claim 1, characterized in that: The spring winding section (80) is a straight structure or an arc structure, and the arc structure is divided into a first spiral section and a straight section from far to near from the middle pushing section (81).

5. The multifunctional superhard guide wire according to claim 1, characterized in that: One end of the middle pushing section (81) close to the head spring winding section (80) is ground integrally with the inner core (800) to form a smooth transition section (810).

6. The multifunctional superhard guide wire according to claim 1, characterized in that: The head spring winding section (80) is a spiral curve structure.

7. The multifunctional superhard guide wire according to claim 6, characterized in that: The head spring winding section (80) is composed of multiple horizontal and vertical spiral sections, the diameters of which decrease in sequence. From far to near the middle pushing section, the preferred dimensions of each spiral section are as follows: The blank part in the table indicates that there is no corresponding spiral segment.

8. A catheter kit containing the multifunctional superhard guidewire of claim 1, characterized in that: It comprises a sheath tube (1), a catheter seat (2), a first three-way valve (3), a hose (4), a second three-way valve (5), and a pressure gauge (6) which are connected in sequence; The front end tube opening (1a) of the sheath tube (1) is an oblique cut, and a guide tube (10) is provided on the outer side of the tube wall where the tip of the oblique cut is located; The catheter seat (2) comprises a main valve tube (20) and a side valve tube (21); the front end of the main valve tube (20) is connected to the rear end of the sheath tube (1), and the side valve tube (21) is communicated with the main valve tube (20) and is connected to the front end of the hose (4) via a first three-way valve (3); The rear end of the hose (4) is connected to a pressure gauge (6) via a second three-way valve (5); The head spring section (80) of the superhard guide wire (8) is inserted from the guide tube (10).

9. The multifunctional catheter kit according to claim 1, characterized in that: The rear end of the guide tube (10) is arranged as an oblique cut; the guide tube (10) extends forward and exceeds the front edge of the front tube opening (1a) of the sheath tube (1), or is flush with it.

10. The multifunctional catheter kit according to claim 1, characterized in that: It also includes a pressure gauge data cable (7) and a data plug (9) connected to the pressure gauge (6).

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