WO2010108308A1

WO2010108308A1 - Guiding guide wire

Info

Publication number: WO2010108308A1
Application number: PCT/CN2009/001363
Authority: WO
Inventors: 杨永森; 王建华; 魏战江; 张田宏
Original assignee: 乐普（北京）医疗器械股份有限公司
Priority date: 2009-03-27
Filing date: 2009-12-03
Publication date: 2010-09-30
Also published as: CN101502693A

Abstract

A guiding guide wire (10) includes a core wire (11) of the guide wire and an elastic jacket. The core wire (11) of the guide wire includes an inner core (19) and an outer layer (18) which enwraps the inner core (19) and is coaxial and concentric with the inner core (19). Along its longitudinal direction, the core wire (11) of the guide wire has a proximal end (12) of the core wire with the same axial diameter and a distal end (13) of the core wire which tapers from near to far in longitudinal direction. A part of the core wire (11) of the guide wire, which is close to the distal end (13) of the core wire, is placed in the elastic jacket.

Description

Guide wire

The present invention relates to the field of medical device technology, and more particularly to a guide wire for guiding and positioning various interventional medical catheters and implantable instruments into human organs in minimally invasive treatment. Background technique

The current main treatment for coronary heart disease is percutaneous coronary intervention

Percutaneous coronary intervention (PCI) „ The guide wire used for coronary intervention requires a certain degree of manipulation, the softness and recovery of the tortuous vessel, the push of the distal action due to the proximal operation, and the corresponding Torque control and so on.

According to the core material, the conventional guide wire for coronary artery can be divided into a core wire type and a two-section core wire type. One core wire type, for example, the entire wire core wire is made of 304 stainless steel. This type of wire has good torque control, but when the operability is good, the head end will partially lose its softness. When a highly elastic material such as a nickel-titanium alloy is selected, although the flexibility and resilience of the head end are ensured, the operability at the proximal end is lowered.

In order to have the required softness and operability, a two-stage core wire guide wire appears on the open field, that is, a stainless steel material with high strength and small elasticity is combined with a low strength but superelastic alloy in some way. The connection is such that both the operability required for the proximal portion and the softness and restorability of the distal end portion at the distal end are ensured, but there are still some drawbacks.

At present, the connection method of the two-stage core wire can be realized by using a tubular connecting member and a direct welded joint at the joint. For the guide wire using the tubular connecting member, although the two required guide wire core wires are connected, there is a joint portion. The problem of low combined strength is that the twist-controlled transmission is not good, the required torque control is not guaranteed, and the tubular connecting member is expensive to manufacture and the processing is cumbersome. At present, the docking of stainless steel and superelastic alloy filaments is a worldwide problem. Although there are precedents for directly welding the two directly, there is still a joint strength of the joint. The problem, in clinical use, when the guide wire enters the human tissue, it is easy to be discounted or broken, affecting the normal operation of the clinic, and easily damaging the human tissue.

Summary of the invention

An object of the present invention is to provide a medical guide wire which is excellent in operability while ensuring flexibility of a distal end portion.

In order to achieve the above object, a guide wire according to an embodiment of the present invention is provided, comprising a guide wire core and an elastic sheath, the guide wire core comprising an inner core and an outer layer encasing the inner core, The guide wire core has a proximal end of the core wire having a uniform outer diameter in the axial direction along the longitudinal direction thereof and a distal end of the core wire which is tapered from the near and outer diameters in the axial direction, and the guide wire core wire is adjacent to a part of the distal end of the core wire Placed in the elastic sheath.

Preferably, the inner core is one or more of a Ni-Ti alloy, a Cu-Zn alloy, a Cu-Zn-X alloy, a Ni-Al alloy, a Ni-Cr alloy, or a Fe-Mn alloy. Or a mixed material comprising at least one of the metal alloys, wherein X in Cu-Zn-X is one or more of Be, Si, Sn, and A1.

Preferably, the outer layer is made of one or more of austenitic stainless steel, martensitic stainless steel, a mixed material including at least one of the foregoing, a cobalt-based alloy, and a mixed material including the cobalt-based alloy. .

Preferably, the shape of the distal end of the core wire is streamlined or parabolic or staged and smooth.

Preferably, the elastic sheath is a spring coil comprising a non-developing spring coil and a developing spring coil connected to a spring connection point, one end of the non-developing spring coil being coupled to an outer surface of the distal end of the core wire. '

Preferably, the elastic sheath is a polymer sheath having a developing spring coil connected to the distal end of the core wire.

Preferably, the inside of the developing spring coil is provided with a shaping section, one end of the shaping section is connected to the end of the distal end of the core wire, and the other end is connected to one end of the developing spring coil through a head end connection point. Preferably, the inside of the developing spring coil is provided with a safety wire, one end of the safety wire is connected to the spring connection point, and the other end is connected to one end of the developing spring coil through a head end connection point.

Preferably, the outer surface of the outer layer is coated with a smooth coating, and the material of the coating is selected from the group consisting of polyethylene, polypropylene, polyvinyl chloride, polyester, polyamide, polyimide, and polyaminocarb. Any one of an acid ester, a polystyrene, a polycarbonate, a silicone, a fluororesin, or a composite comprising at least one of the materials.

Preferably, the distal end of the core wire and the outer surface of the elastic sheath are coated with a hydrophilic material.

The guide wire of the invention not only utilizes the high elastic property of the high elastic alloy material, but also imparts softness and recovery to the head end of the guide wire, and utilizes the high strength and rigidity of the metal and alloy material with high rigidity to ensure the guide. The pushability of the wire and the corresponding torque control make the guide wire controllable.

detailed description

The specific embodiments of the present invention are further described in detail below with reference to the drawings and embodiments. The following examples are intended to illustrate the invention but are not intended to limit the scope of the invention.

1 is a front elevational view of a guide wire in accordance with an embodiment of the present invention;

Figure 2 is a cross-sectional view taken along line 2-2 of Figure 1;

Figure 3 is a cross-sectional view taken along line 3-3 of Figure 1;

Figure 4 is a partial enlarged view of a guide wire in accordance with an embodiment of the present invention;

Figure 5 is a front elevational view of a guide wire structure in accordance with another embodiment of the present invention; Figure 6 is a cross-sectional view taken along line 6-6 of Figure 5;

Figure 7 is a cross-sectional view taken along line 7-7 of Figure 5;

Figure 8 is a partial enlarged view of a guide wire in accordance with another embodiment of the present invention.

In the figure: 10, 40: guide wire; 11, 41: wire core wire; 12, 42: proximal end; 13, 43: distal end; 14, 45: spring coil; 15, 16: tapered portion; : parabolic part; 17, 46: shaped section; 18, 48: outer layer; 19, 47: inner core; 20, 49: Head connection point; 22, 51: spring connection point; 23, 52: development spring coil; 24, 53: non-developing spring coil; 25, 54: coating; 26, 55: safety wire.

1 and 5 are front views of two embodiments of the guide wire of the present invention; FIGS. 4 and 8 are partial enlarged views of two corresponding embodiments; FIG. 2 and FIG. 3 are guides of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS Fig. 6 and Fig. 7 are cross-sectional views of the guide wire of the present invention taken along line 6-6, 7-7 of Fig. 5. For convenience of explanation, the right side in Fig. 1, Fig. 4, Fig. 5, and Fig. 8 is "distal" and the left side is "near end".

The guide wire 10 shown in Figures 1 to 3 has a guide wire core 11 and a helical spring coil 14 which is divided into a proximal end 12 of the core wire and a distal end 13 of the core wire, wherein the core wire is far The end 13 has two tapered portions, a tapered portion 15 and a tapered portion 16, respectively, and a distal end of the tapered portion 16 is connected to a shaped section 17.

The guide wire core 11 of the guide wire 10 is formed from a single metal composite material until the shaped portion is formed into a desired tapered portion and a shaped portion by centerless grinding. The inner core 19 of the metal composite is a highly elastic alloy material, the outer layer 18 is tightly wrapped with a relatively rigid metal and alloy material, and the inner core 19 is coaxially concentric with the outer layer 18. Selectable metals and alloys with high rigidity are austenitic stainless steels such as SUS304, SUS316, and SUS316L, and martensitic stainless steels such as SUS 403, SUS 410, SUS 420, SUS 440C, and 1RK91, MP35N, L605, Elgiloy, 3J21 A cobalt-based alloy, or a mixed material comprising at least one of the foregoing metals and alloys. The optional high elastic alloy material is a Ni-Ti alloy, a Cu-Zn alloy, a Cu-Zn-X alloy (X is at least one of Be, Si, Sn, and A1), a Ni-Al alloy, and Ni. a -Cr alloy, a Fe-Mn alloy, or the like, or a mixed material including at least one of the foregoing metal alloys.

The guide wire core 11 shown in Figs. 1 and 2 is composed of an outer layer 18 which is tightly covered with an inner core 19. The outer layer 18 has an arbitrary shape in cross section, preferably a circular shape, and a diameter preferably ranges from 0.1 to 0.89 mm. The cross section of the inner core 19 is of any shape, preferably circular, and the diameter preferably ranges from 0.01 to 0.8 mm.

The length of the proximal end 12 of the guide wire 10 is preferably 65 to 280 cm, and the cross section is any The shape is preferably circular, the preferred range of diameter is 0.1 to 0.89 mm, and the diameter of the guide wire for coronary artery is 0.30 to 0.46 mm. The diameter of the first tapered portion 15 of the core wire distal end 13 of the wire core wire 11 preferably ranges from 0.89 to 0.15 mm, the taper preferably ranges from 0 to 25 degrees, and the length preferably ranges from 0 to 15 cm; the second tapered portion The diameter of 16 is preferably in the range of 0.15 to 0.013 mm, the taper is preferably in the range of 0 to 25 °, and the length is preferably in the range of 0 to 15 cm. The distal end 13 may have a plurality of tapered portions that are spaced or connected to each other. The taper of each tapered portion preferably ranges from 0 to 25°, the length preferably ranges from 0 to 15 cm, and the cross-section of each tapered portion is arbitrary. It is preferably circular. Here, the taper refers to the angle between the axial direction of the core wire and the tangent to the surface of the tapered portion.

The shaped section 17 extends from the tapered portion 16 up to the head end connection point 20. The spring coil 14 is divided into a developing spring coil 23 and a non-developing spring coil 24, both of which are connected at a spring connection point 22. The distal end of the developing spring coil 23 is connected to the distal end of the shaping section 17 at the head end connection point 20, and the proximal end of the non-developing spring coil 24 is connected at the connection point 21 to the outer surface of the distal end 13 of the core wire.

The head end connection point 20 is formed into a hemispherical curved surface, which helps the guide wire to enter the human body tissue, enhances the passage of the guide wire, and does not damage the human tissue. The purpose of adding the spring coil 14 to the tip end of the guide wire 10 is to improve the softness of the tip end of the guide wire, and not to damage the human tissue, and the addition of the spring coil 14 can improve the tactile feedback of the operator and improve the guide wire 10 of the guide wire 10 Operational performance.

The spring coil 14 preferably has a length in the range of 3 to 45 cm and has a diameter which is identical to the proximal end portion 12 of the core wire and is wound from a wire having a diameter preferably ranging from 0.025 to 0.1 mm. For the non-developing spring coil 24, a high-strength metal material such as stainless steel may be selected, and the developing spring coil 23 may be made of platinum or an alloy thereof, or other material such as a stainless steel material, and then coated with a developing material such as gold or tungsten powder. The spring coil 14 can also be replaced by a soft polymeric sheath such as polyimide, polyethylene, polyurethane, polytetrafluoroethylene (PTFE), and the like. There is a developing spring coil 23 in the polymer sheath, which is connected between the distal end 13 of the core wire and the head end connection point 20 to facilitate the treatment process. Improve the visibility of the guide wire in the diseased blood vessel or body cavity.

Figure 3 is a cross-sectional view taken along line 3-3 of Figure 1, the length of the shaped section 17 preferably ranges from 1 to 4 cm, the cross section is of any shape, preferably rectangular, and the size is 0.013 to 0.051 mm X 0.051- 0.152 mm, preferably 0.025 mm x 0.076 mm.

In order to increase the passage of the guide wire 10 and reduce the friction, the wire core wire 11 is coated with a smooth coating 25, and the coating material may be polyethylene, polypropylene, polyvinyl chloride, polyester (PET, PBT, etc.). , polyamide, polyimide, polyurethane, polystyrene, polycarbonate, silicone, fluororesin (PTFE, ETFE, etc.) or a composite thereof. The polymer coating 25 is applied to the guide wire 10 by heat shrinkage, dipping, spraying, coating, vapor phase precipitation, coextrusion or molding. The coating is often aged at room temperature or accelerated by heating, and the guide wire may be heated prior to application to promote adhesion of the coating.

The surface of the core wire distal end 13 of the wire core wire 11 and the spring coil 14 are coated with a hydrophilic material, which utilizes the wetting of the hydrophilic material to produce lubricity, reduces the frictional resistance of the guide wire, and improves the operation of the guide wire. Sex. Alternative hydrophilic materials are polyacrylamide, polyglycidyl methacrylate, water soluble nylon, polyvinyl alcohol, and the like.

Figure 4 is a partial enlarged view of the guide wire of the present invention, in which the shaped section 17 of the distal end portion of the guide wire 11 is replaced by a safety wire 26 whose distal end is connected to the tip of the non-developing spring coil 23 at the tip end. 20 is connected, the proximal end being connected to the distal end 13 of the core wire of the guide wire 11 at the spring connection point 22. The length of the safety wire 26 is preferably in the range of 1 to 4 cm, and the cross-sectional dimension is preferably 0.013 to 0.051 mm X 0.051 to 0.152 mm.

Since the proximal end 12 of the core wire 11 for interventional treatment of the present invention is made of a metal and an alloy material having a large rigidity, the twist control is ensured, the operation is good, and the inner core is elastic due to the grinding of the head end. The alloy material is exposed, and it is used as the core end 13 of the core wire 11 to impart excellent flexibility and recovery to the head end, which is very advantageous for clinical use.

The length of the guidewire 10 for interventional treatment of the present invention preferably ranges from 80 to 300 cm, and the most common coronary guidewire has a length of 180 cm or 195 cm.

Figure 5-7 shows a guide wire 40 having a guide wire core 41 and a helical spring The coil 45, the wire core wire 41 is divided into a core wire proximal end 42 and a core wire distal end 43, and the core wire distal end 43 has a first-line linear, parabolic portion 44 which can be interpreted as a continuous change in the taper of the tapered portion. The streamlined portion 44 is coupled to a shaped section 46.

The guide wire core wire 41 is formed of a whole metal composite material up to the shaping section 46.

5 The center of the end is made into a streamlined portion and a shaped portion by centerless grinding. The metal composite inner core 47 is an elastic alloy material, and the outer layer 48 is tightly wrapped with a rigid metal and alloy material, which are coaxially concentric. Selectable metals and alloys of high rigidity are austenitic stainless steels such as SUS304, SUS316, and SUS316L, SUS 403, SUS 410, SUS 420 SUS 440C, and martensitic stainless steels such as 1RK91, MP35N, L605, Elgiloy, io 3J21, etc. A cobalt-based alloy, or a mixed material comprising at least one of the foregoing metals and alloys. The optional elastic large alloy material is a Ni-Ti alloy, a Cu-Zn alloy, a Cu-Zn-X alloy (X is at least one of Be, Si, Sn, Al), a Ni-Al alloy, Ni a -Cr alloy, a Fe-Mn alloy, or the like, or a mixed material including at least one of the foregoing metal alloys.

The guide wire 40 shown in Figs. 5 and 6 is composed of an outer layer 48 in which the inner core 47 is tightly wrapped.

15 The inner core 47 has an arbitrary shape, preferably a circular shape, preferably having a diameter of 0.1 to 0.89 mm, and the outer layer 48 has an arbitrary shape in cross section, preferably a circular shape, and a preferred range of diameter is 0.01 to 0.8 mm. .

The length of the proximal end 42 of the guide wire 40 is preferably in the range of 65 to 280 cm, the cross section is of any shape, preferably circular, and the preferred range of diameter is 0.1 to 0.89 mm, and the diameter of the coronary artery is 0.30 to 0.46 mm. . The distal end 43 of the core wire of the guide wire 40 has a predominantly linear, parabolic portion 44 which can be interpreted as being caused by a continuous change in taper of the tapered portion. The streamlined, parabolic portion 44 preferably has a length of 0 to 60 cm or 5 to 35 cm, and in particular, 10 to 25 cm. This configuration provides a linear change in the stiffness of the distal portion of the guidewire. The streamlined, parabolic portion 44 extends out of the head end shaped section 46 up to the head end hemispherical attachment point 49. The spring coil 45 is divided into a developing spring coil 52 and a non-developing spring coil 53, which are connected to the spring connection point 51. The distal end of the developing spring coil 52 and the shaped section The distal end of the 46 is connected at a connection point 49, and the proximal end of the non-developing spring coil 53 is connected to the distal core wire 43 at a connection point 50.

Figure 6 is a cross-sectional view of the guide wire 40 according to the line 6-6 of Figure 5, the core wire 41 has a cross section of any shape, preferably a circular shape, the surface of which is coated with a smooth coating 54, the coating material can be For polyethylene, polypropylene, polyvinyl chloride, polyester (ΡΕΤ, ΡΒΤ, etc.), polyamide, polyimide, polyurethane, polystyrene, polycarbonate, silicone, fluororesin (PTFE, ETFE, etc.), and their composite materials. The surface of the distal end 43 of the guide wire 40 and the spring coil 45 may also be coated with a hydrophilic material, which utilizes the wetting of the hydrophilic material to produce lubricity, reduces the frictional resistance of the guide wire, and improves the operability of the guide wire. The optional hydrophilic materials are polyacrylamide, polyglycidyl methacrylate, water-soluble nylon, polyvinyl alcohol, and the like.

Figure 7 is a cross-sectional view of the guide wire 40 in the line 7-7 of Figure 5 with the spring coil 45 placed on the head end shaped section 46.

Figure 8 is a partial enlarged view of the embodiment of the guide wire 40, in which the shaped section 46 of the distal end portion of the guide wire is replaced by a safety wire 55, the distal end of the safety wire 55 and the development spring coil 52 are connected at the tip end. 55 is connected, and the proximal end of the safety wire 55 is connected to the distal end 43 of the guide wire 40 at the spring connection point 51. Similarly, the streamlined, parabolic portion 44 in this configuration provides a linear change in the stiffness of the distal portion of the guidewire. The length of the safety wire 55 is preferably in the range of 1 to 4 cm, and the cross-sectional size is preferably in the range of 0.013-0.051 mm χ 0.05 bu 0.152 mm „

The above is only a preferred embodiment of the present invention, and it should be noted that those skilled in the art can make several improvements and modifications without departing from the technical principles of the present invention. It should also be considered as the scope of protection of the present invention. Industrial applicability

The guide wire of the invention not only utilizes the high elastic property of the high elastic alloy material, but also imparts softness and recovery to the head end of the guide wire, and utilizes the high strength and rigidity of the metal and alloy material with high rigidity to ensure the guide. The wire's pushability and corresponding torque control make the wire easy to handle. The guide wire of the invention can be widely applied to the need to guide and position into the human body Various clinical interventions for medical minimally invasive treatment of medical catheters and implantable devices.

Claims

Rights request

A guide wire, characterized in that the guide wire comprises a wire core wire (11) and an elastic sheath (14), the wire core wire (11) comprising an inner core (19) and a package The inner core (19) and an outer layer (18) coaxial with the inner core (19), the guide wire core wire (11) having a proximal end of the core wire having the same outer diameter in the axial direction along the longitudinal direction thereof (12) and a distal end (13) of the core wire whose axial direction is tapered from the proximal and distal outer diameters, the guide wire core wire (11) being placed in the elastic sheath near a portion of the distal end (13) of the core wire (14) Medium.

The guide wire according to claim 1, wherein the inner core (19) is made of a Ni-Ti alloy, a Cu-Zn alloy, a Cu-Zn-X alloy, a Ni-Al alloy, and Ni. Any one or more of a -Cr alloy or an Fe-Mn alloy, or a mixed material including at least one of the metal alloys, wherein X in Cu-Zn-X is Be, Si, Sn One or several of A1.

The guide wire according to claim 2, wherein the outer layer (18) is made of austenitic stainless steel, martensitic stainless steel, a mixed material comprising at least one of the two, a cobalt-based alloy, One or more of the mixed materials including the cobalt-based alloy are made.

The guide wire according to any one of claims 3, wherein the outer end of the core wire has a streamlined or parabolic shape or a staged smoothness type.

The guide wire according to claim 1, wherein the elastic sheath (14) is a spring coil including a non-developing spring coil (24) and a developing spring coil connected to a spring connection point (22) (23), one end of the non-developing spring coil (24) is coupled to an outer surface of the distal end (13) of the core wire.

The guide wire according to claim 1, wherein the elastic sheath (14) is a polymer sheath having a developing spring coil connected to the distal end (13) of the core wire ( twenty three).

The guide wire according to claim 6, wherein the inside of the developing spring coil (23) is provided with a shaping section (17), and one end of the shaping section (17) is connected to the core The end of the distal end of the wire (13) and the other end are connected to one end of the developing spring coil (23) through a head end connection point (20).

The guide wire according to claim 6, wherein the inside of the developing spring coil (23) is provided with a safety wire (55), and one end of the safety wire (55) is connected to the spring connection point. ( twenty two ), The other end is connected to one end of the developing spring coil (23) through a head end connection point (20).

The guide wire according to any one of claims 1 to 8, wherein the outer surface of the outer layer (18) is coated with a smooth coating, and the material of the coating is selected from polyethylene. Any one of polypropylene, polyvinyl chloride, polyester, polyamide, polyimide, polyurethane, polystyrene, polycarbonate, silicone, fluororesin, or at least one A composite of the materials described.

10. The guide wire according to claim 9, wherein the outer end surface of the core wire (13) and the outer surface of the elastic sheath (14) are coated with a hydrophilic material.