CN117717694A - Aortic valve guide wire - Google Patents
Aortic valve guide wire Download PDFInfo
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- CN117717694A CN117717694A CN202410179333.9A CN202410179333A CN117717694A CN 117717694 A CN117717694 A CN 117717694A CN 202410179333 A CN202410179333 A CN 202410179333A CN 117717694 A CN117717694 A CN 117717694A
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- reducing
- aortic valve
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Abstract
The invention relates to an aortic valve guide wire, belongs to the technical field of medical appliances, and solves the problem of high probability of ventricular perforation in the prior art. Comprises a core wire, a reducing wire, an outer side wire winding and a balloon; the core wire is a hollow catheter and comprises a core wire beveling end and a core wire proximal end, and the reducing wire is shaped into a spiral shape by a stepped reducing wire or an electrodeless reducing wire and comprises a reducing wire proximal end and a reducing wire distal end; the outer wire wrap includes an outer wire wrap proximal end and an outer wire wrap distal end; the balloon comprises a balloon proximal end, a balloon middle section and a balloon distal end; the core wire beveling end, the reducing wire proximal end, the outer wire winding proximal end and the balloon proximal end are bonded or welded; the distal end of the variable diameter wire, the distal end of the outer wire winding and the distal end of the balloon are bonded or welded; the outside winding wire wraps the core wire beveling end and the reducing wire; the balloon is wrapped around the beveled end of the core wire and the outer wire wrap. The aortic valve guide wire can improve the supporting force of the guide wire in a ventricle, reduce the probability of deformation of the guide wire under extrusion, and reduce the probability of ventricular perforation.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to an aortic valve guide wire.
Background
Guide Wire (Guide Wire), also known as a Guide Wire or guidewire, is one of the main tools for percutaneous puncture surgery. The guide wire plays a role in guiding and supporting the catheter conveyed by the instrument, meanwhile, the guide wire can establish a conveying track for the instrument to enter a human body, guide the instrument to enter lesion positions such as blood vessels or other cavities, and the guide wire is a precondition that the instrument can smoothly reach the lesion positions.
Aortic valve guidewires are used in aortic valve interventional procedures (TAVAR) to establish valve delivery tracks that play an important supporting role during valve delivery. The percutaneous implantable aortic valve has a complex structure, the required diameter of the conveying sheath tube is larger, and in addition, the patient has hardened and distorted aorta, so that when the artificial valve is pushed into the heart along the conveying sheath tube, the tension and the resistance are large, and a guide wire needs to be placed in the left ventricle cavity to serve as an aortic valve pushing track so as to avoid the damage of the conveying device to the aortic wall. However, due to the fact that the pushing force of the aortic valve is very large, the guide wire in the left ventricle is often caused to shift and deform in a compression mode, the force generated by the shift and the deformation of the guide wire acts on the cardiac muscle of the left ventricle, and due to the fact that the diameter of the guide wire is small, the contact area between the guide wire and the cardiac muscle is small, the cardiac muscle of the left ventricle is easily perforated, and life of a patient is endangered.
At present, the existing aortic valve guide wire has a structure that a head end is made into a spiral shape with gradually changed hardness, the main purpose is to enable the guide wire to be fixed in a heart, movement of the guide wire in a valve conveying process is reduced, and meanwhile, the head end is soft and ventricular perforation of a certain proportion can be reduced. However, the problem of ventricular perforation cannot be fundamentally solved by the method, because the reaction force is large in the valve conveying process, the guide wire is inevitably extruded to advance and compress, and because the diameter of the guide wire is too small and the contact area is small, the force of the guide wire on the cardiac muscle is still large, and the risk of perforation of the cardiac muscle is not remarkably reduced. Therefore, there is a need for an aortic valve guide wire that increases the contact area with the heart muscle and reduces the probability of ventricular perforation.
Disclosure of Invention
In view of the above analysis, the present invention aims to provide an aortic valve guide wire, which is used for solving the problems of insufficient supporting force, easy deformation and displacement under extrusion, small contact area with cardiac muscle and large probability of ventricular perforation of the existing aortic valve guide wire.
The aim of the invention is mainly realized by the following technical scheme:
the invention provides an aortic valve guide wire, which comprises a core wire, a reducing wire, an outside winding wire and a balloon;
the core wire is a hollow catheter and comprises a core wire beveling end and a core wire proximal end;
the reducing wire is shaped into a spiral shape by a stepped reducing wire or an electrodeless reducing wire, and comprises a reducing wire proximal end and a reducing wire distal end;
the outer wire wrap includes an outer wire wrap proximal end and an outer wire wrap distal end;
the balloon comprises a balloon proximal end, a balloon middle section and a balloon distal end;
the core wire beveling end, the reducing wire proximal end, the outer wire winding proximal end and the balloon proximal end are bonded or welded; the variable diameter wire distal end, the outer wire winding distal end and the balloon distal end are bonded or welded;
the outer wire winding covers the core wire beveling end and the reducing wire;
the balloon wraps the beveled end of the core wire and the outer wire wrap.
Further, the chamfer angle of the chamfer end of the core wire is 20+/-1 degrees.
Further, the diameter of the proximal end of the reducing wire is 0.35+/-0.01 mm, the diameter of the distal end of the reducing wire is 0.05+/-0.01 mm, and the length of the reducing wire is 212.29-409.43mm.
Further, the helical pitch is 1.45-8.45mm, the number of helical layers is 4-5, and the diameter is 10-50mm.
Further, the outside wire winding is formed by winding round metal wires, the diameter of the round metal wires is 0.08+/-0.005 mm, the winding outer diameter is less than or equal to 0.86mm, and the winding pitch is 0.16+/-0.05 mm.
Further, the outside wire winding is formed by winding a flat metal wire, the section length of the flat metal wire is 0.255+/-0.02 mm, the thickness of the flat metal wire is 0.08+/-0.005 mm, the winding outer diameter of the flat metal wire is less than or equal to 0.86mm, and the winding pitch of the flat metal wire is 0.16+/-0.05 mm.
Further, the middle section of the balloon is a straight thin-wall balloon body or a tube body, the outer diameter of the balloon is 1.0+/-0.1 mm, the wall thickness of the balloon is 0.02+/-0.01 mm, and the length of the balloon is 220-480mm.
Further, the middle section of the balloon is a thin-wall balloon body or a tube body comprising a plurality of bulges and straight line sections, the shapes and the lengths of the bulges are the same, and the length is 10-15mm; the length of the straight line segments is the same and is 5-10mm.
Further, the surfaces of the core wire and the outer wire winding are coated with polytetrafluoroethylene ultra-slip coatings.
Further, a developing material is included between the reducing wire and the outer winding wire.
Compared with the prior art, the invention has at least one of the following beneficial effects:
1. compared with the conventional linear or curved guide wire end, the guide wire end of the aortic valve guide wire is in a three-dimensional spiral shape, so that the support force of the guide wire in a ventricle can be improved, the deformation probability of the guide wire under extrusion is reduced, and the perforation probability of the ventricle can be reduced.
2. In one possible structure, the three-dimensional spiral shape of the balloon along with the variable-diameter wire in the aortic valve guide wire completely wraps the end of the guide wire, the balloon is tightly attached to the end of the guide wire in a folded state when not in use, pressure is applied to enable the balloon 4 to be full when in use, the whole balloon 4 is inflated in a spiral shape, and compared with the existing guide wire structure, the contact area of the balloon and cardiac muscle is improved, and the probability of ventricular perforation is greatly reduced.
3. In one possible structure, the balloon in the aortic valve guide wire of the invention is composed of a plurality of bulges and straight line segments, the balloon integrally covers the guide wire head end, when in use, pressure is applied to enable the balloon to be full, the plurality of bulge parts are full and inflated, and the plurality of straight line segments are not full and inflated, so that the balloon 4 is in a ' spiral ' filling and inflation ' shape in a ' sugar-gourd string ' shape integrally; the balloon like the sugar-chain balloon can fix the position of the guide wire in the balloon when the guide wire is pressed, so that the guide wire is positioned in the middle of the balloon instead of being tightly attached to the lower wall of the balloon, the pressure of the guide wire on a ventricle can be better relieved, and the perforation probability of the ventricle can be better reduced.
4. The aortic valve guide wire comprises a core wire in a structure, wherein the surfaces of the outer side wire winding and the saccule are coated with coatings, so that the resistance of the guide wire in the pushing and withdrawing processes in the operation process is reduced.
In the invention, the technical schemes can be mutually combined to realize more preferable combination schemes. Additional features and advantages of the invention will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The objectives and other advantages of the invention may be realized and attained by the structure particularly pointed out in the written description and drawings.
Drawings
The drawings are only for purposes of illustrating particular embodiments and are not to be construed as limiting the invention, like reference numerals being used to designate like parts throughout the drawings;
FIG. 1 is a schematic illustration of the connection of a core wire and a reducing wire of an aortic valve guide wire of the present invention;
FIG. 2 is a schematic illustration of an aortic valve guide wire structure according to example 1 of the present invention;
FIG. 3 is a schematic illustration of an aortic valve guide wire structure according to example 2 of the present invention;
FIG. 4 is a schematic illustration of an aortic valve guide wire structure according to example 3 of the present invention;
FIG. 5 is a schematic view of a core wire in an aortic valve guide wire of the present invention;
FIG. 6a is a schematic view of a stepped variable diameter wire of the aortic valve guide wire of the present invention;
FIG. 6b is a schematic view of an electrodeless variable diameter wire of the aortic valve guide wire of the present invention;
FIG. 7a is a schematic view of a tapered wire spiral cone sizing of an aortic valve guide wire of the present invention;
FIG. 7b is a schematic view of a variable diameter wire helical cylindrical sizing of an aortic valve guide wire of the present invention;
FIG. 8a is a schematic view of a flattened outer wire wrap of an aortic valve guidewire of the present invention;
FIG. 8b is a schematic view of a circular outer wrap of an aortic valve guide wire of the present invention;
FIG. 9a is a schematic view of an aortic valve guidewire balloon according to example 1 of the present invention;
FIG. 9b is a schematic view of an aortic valve guidewire balloon according to example 2 of the present invention;
FIG. 10 is a schematic cross-sectional view of an aortic valve guide wire of the present invention;
fig. 11 is a folded schematic view of the aortic valve guide wire of the present invention.
Reference numerals:
1-core wire; 2-reducing wires; 3-outer winding; 4-balloon; 5-proximal core wire end; 6-proximal end; 7-distal; l-flat wire cross-sectional length.
Detailed Description
Preferred embodiments of the present invention will now be described in detail with reference to the accompanying drawings, which form a part hereof, and together with the description serve to explain the principles of the invention, and are not intended to limit the scope of the invention.
The invention provides an aortic valve guide wire, which comprises a core wire 1, a reducing wire 2, an outer side winding wire 3 and a balloon 4;
the core wire is a hollow catheter and comprises a core wire beveling end and a core wire proximal end;
the reducing wire is shaped into a spiral shape by a stepped reducing wire or an electrodeless reducing wire, and comprises a reducing wire proximal end and a reducing wire distal end;
the outer wire wrap includes an outer wire wrap proximal end and an outer wire wrap distal end;
the balloon comprises a balloon proximal end, a balloon middle section and a balloon distal end;
the core wire beveling end, the reducing wire proximal end, the outer wire winding proximal end and the balloon proximal end are bonded or welded; the variable diameter wire distal end, the outer wire winding distal end and the balloon distal end are bonded or welded;
the outer wire winding covers the core wire beveling end and the reducing wire;
the balloon wraps the beveled end of the core wire and the outer wire wrap.
At present, the aortic valve guide wire on the market is not provided with a balloon, the core wire part is not hollow but is of a solid structure, the core wire and the reducing wire are formed by one body instead of welding, and the shape of the reducing wire is straight or plane bending. Compared with the conventional linear or curved guide wire end, the aortic valve guide wire can improve the supporting force of the guide wire in a ventricle, reduce the deformation probability of the guide wire under extrusion and reduce the perforation probability of the ventricle; compared with the existing guide wire, the aortic valve guide wire has the advantages that the contact area between the balloon and cardiac muscle is increased, and the ventricular perforation probability is greatly reduced.
Specifically, the core wire 1 is a hollow catheter, and one end of the core wire 1 is in a beveling design so as to achieve the effect of gradual change of hardness; one end of the core wire 1 adopting the beveling design is called a beveling end, and the other end of the core wire 1 is called a core wire proximal end; the length of the core wire 1 is 2400+/-140 mm, the chamfer angle of the chamfer end is 20+/-1 degrees, the outer diameter is 0.76+/-0.02 mm, the inner diameter is 0.20+/-0.04 mm, and the wall thickness is 0.28+/-0.01 mm; the core wire 1 is made of 304 stainless steel or nickel titanium metal material, the surface of the core wire 1 can be coated with PTFE (polytetrafluoroethylene) ultra-slip coating to reduce the assembly resistance when the balloon 4 is assembled, the thickness of the coating is 0.004-0.010mm, and the beveled end is 2-4mm outwards along the direction of the proximal end of the core wire and is free of the coating, so that the welding or bonding of the diameter-variable wire 2, the outer winding wire 3 and the balloon 4 with the core wire 1 is facilitated. A schematic of the core wire of the aortic valve guide wire of the present invention is shown in fig. 5.
Specifically, the reducing wire 2 is shaped into a spiral shape by a stepped reducing wire or an electrodeless reducing wire, the material is 304 stainless steel or nickel titanium metal, the reducing wire 2 comprises a proximal end, a middle section and a distal end, one end which is bonded or welded with the beveled end of the core wire 1 is the proximal end of the reducing wire 2, the other end is the distal end of the reducing wire 2, and the part between the proximal end and the distal end of the reducing wire 2 is called as the middle section of the reducing wire 2; FIG. 6a is a schematic view of a stepped variable diameter wire of the aortic valve guide wire of the present invention; FIG. 6b is a schematic view of an electrodeless variable diameter wire of the aortic valve guide wire of the present invention; FIG. 7a is a schematic view of a tapered wire spiral cone sizing of an aortic valve guide wire of the present invention; FIG. 7b is a schematic view of a variable diameter wire helical cylindrical sizing of an aortic valve guide wire of the present invention; FIG. 1 is a schematic illustration of the connection of the core wire and the reducing wire of the aortic valve guide wire of the present invention.
The pitch of the reducing wire 2 is 1.45-8.45mm, the number of layers is 4-5, and the diameter is 10-50mm; the total length of the reducing wire 2 is 212.29-471.16mm, the diameter of the proximal end of the reducing wire 2 is 0.35 plus or minus 0.01mm, and the diameter of the distal end of the reducing wire 2 is 0.05 plus or minus 0.01mm after stepped diameter change or stepless diameter change. The hardness of the distal end of the reducing wire 2 can be gradually reduced by reducing, and the flexibility of the reducing wire is improved; compared with the linear or curved variable diameter wire commonly used for the existing guide wire, the variable diameter wire is spiral, so that the supporting force of the guide wire in a ventricle can be improved, the deformation probability of the guide wire under extrusion is reduced, and the perforation probability of the ventricle is reduced;
preferably, the diameter-variable wire 2 is shaped into an equidistant conical spiral shape by a stepped diameter-variable wire or an electrodeless diameter-variable wire, the pitch of the diameter-variable wire 2 is 1.45-8.45mm, the apex angle of the cone is 30-60 degrees, the number of layers is 4-5, the diameter of the outermost layer of the cone is 30-50mm, and the diameter of the innermost layer of the cone is 10+/-0.5 mm.
Specifically, the material of the outer wire winding 3 is 304 stainless steel or nickel titanium metal material, and the surface can be coated with PTFE (polytetrafluoroethylene) ultra-smooth coating;
the outer wire winding 3 is formed by winding round or flat metal wires, and the length of the outer wire winding is required to be satisfied so as to completely cover the beveling end of the core wire 1 and the reducing wire 2; one end of the outer winding wire 3 is welded with the bevelled end of the core wire 1, namely the proximal end of the outer winding wire 3; the other end of the outer wire winding 3 is welded with the far end of the reducing wire 2 in a flush way, namely the far end of the outer wire winding 3 is welded into a hemispherical shape as a plug, so that the inner wall of a ventricle is not damaged when the guide wire is pressed in the ventricle; when the flat wire or round wire is used for winding to form the outer side winding wire 3, the outer side winding wire is not tightly wound and a certain pitch is reserved; if the outer side wire winding 3 is formed by winding flat wires, the section length L of the flat wires is 0.255 plus or minus 0.02mm, the thickness is 0.08 plus or minus 0.005mm, the winding outer diameter is less than or equal to 0.86mm, and the winding pitch is 0.16 plus or minus 0.05mm; if the outer wire winding 3 is formed by winding round wires, the diameter of the round wires is 0.08 plus or minus 0.005mm, the winding outer diameter is less than or equal to 0.86mm, and the winding pitch is 0.16 plus or minus 0.05mm. FIG. 8a is a schematic view of a flattened outer wire wrap of an aortic valve guidewire of the present invention; fig. 8b is a schematic view of a circular outer wrap of an aortic valve guide wire of the present invention.
In one possible structure, the balloon 4 comprises a balloon proximal end, a balloon middle section and a balloon distal end, and the balloon middle section is a straight thin-wall balloon body or a tube body in a natural state; when in use, the balloon completely wraps the end of the thread guide head along with the three-dimensional spiral shape of the variable-diameter thread 2, and pressure is applied to enable the balloon 4 to be full, so that the whole balloon 4 is inflated in a spiral shape; one end of the saccule 4 wrapping the bevelled end of the core wire 1 is the proximal end of the saccule 4 and is connected with the bevelled end of the core wire 1 through bonding or welding; one end of the balloon 4 wrapping the distal end of the outer wire winding 3 is the distal end of the balloon 4; the outer diameter of the balloon is 1.0 plus or minus 0.1mm, the wall thickness is 0.02 plus or minus 0.01mm, and the length of the balloon is 220-480mm; the guide wire head end is the bevel end of the core wire 1 to the far end of the outer wire winding 3.
In one possible structure, the balloon 4 comprises a balloon proximal end, a balloon middle section and a balloon distal end, and in a natural state, the balloon middle section is a thin-wall balloon body or a tube body comprising a plurality of bulges and straight line sections; when the balloon is used, the three-dimensional spiral shape of the variable diameter wire 2 completely wraps the end of the wire guide head, pressure is applied to enable the balloon 4 to be full, a plurality of convex parts are full and expanded, a plurality of straight line sections are not full and expanded, and the whole balloon 4 is in a spiral shape of a sugar-gourd string and is full and expanded; the shape of the protrusions and the length of the straight line segment between each protrusion can be self-determined according to the design and use requirements of the guide wire. Preferably, the number of projections is 11-28; each protrusion has the same shape and length and the length is 10-15mm; the length of the straight line segment between each balloon is the same and is 5-10mm.
The balloon 4 is a thin-wall balloon body or a tube body, and can be a compliant, semi-compliant or non-compliant balloon, and is made of one of TPU, TPE, silica gel, rubber, latex and pebax, nylon, PE, PET, PVC, and the hardness of the material is 5-100A; the surface of the balloon 4 may also be coated with a PTFE (polytetrafluoroethylene) ultra-slip coating or a hydrophilic polyurethane material to reduce frictional resistance during guidewire advancement and retraction.
Specifically, the surface of the core wire 1 and the surface of the outer wire winding 3 are coated with a PTFE (polytetrafluoroethylene) ultra-slip coating, so that the assembly resistance of the balloon 4 during assembly can be reduced. When the balloon 4 is a thin-walled balloon or tube of soft compliant material, it has a relatively high expansion coefficient, and can expand from a smaller diameter to a larger diameter, and the balloon should be as close to the guidewire as possible or have a relatively small gap before expansion. When the balloon 4 is a thin-wall balloon body or a tube body made of semi-compliant or non-compliant materials, the balloon is required to be wound on an outer wire winding in a folding mode, and is inflated when in use, so that the surface of the balloon is inflated and unfolded, and the compression to cardiac muscle caused by overhigh and hard balloon pressure is avoided.
Developing material may be added between the variable diameter wire 2 and the outer wire wrap 3 to increase the developing effect of the spinneret end. The developing material may be a metallic material or a nonmetallic material containing a metal developing component, the metallic material may be bonded or welded to both ends of the variable diameter wire 2 and the outer wire 3 in such a manner that the developing wire is wound, and the nonmetallic material may be directly bonded or welded to the variable diameter wire 2.
When the aortic valve guide wire is used, after the guide wire is pushed to the operation position, the developer is pushed into the guide wire, so that the balloon at the front end of the guide wire is filled, the balloon in the aortic valve guide wire can be expanded to 2-15 times of the diameter of the guide wire (namely the diameter of the outermost layer of the variable-diameter wire 2), the contact area of the guide wire and the heart wall is obviously increased, and the pressure of the guide wire, generated in the pushing process of the aortic valve and other instruments, on the heart myocardial wall can be obviously buffered, so that the risk of ventricular perforation is greatly reduced. When the operation is completed and the guide wire needs to be retracted, the balloon on the guide wire is completely contracted and then is retracted, so that the resistance of the guide wire during retraction is reduced. FIG. 10 is a schematic cross-sectional view of an aortic valve guide wire of the present invention; fig. 11 is a folded schematic view of the aortic valve guide wire of the present invention.
The aortic valve guide wire can improve the supporting force of the guide wire in a ventricle, reduce the probability of deformation of the guide wire under extrusion, and reduce the probability of ventricular perforation.
Example 1
The aortic valve guide wire of the embodiment comprises a core wire 1, a reducing wire 2, an outer side winding wire 3 and a balloon 4; as shown in fig. 2.
The core wire 1 is an SUS304 stainless steel hollow catheter, the surface of the core wire 1 is coated with PTFE (polytetrafluoroethylene) ultra-smooth coating, the core wire comprises a core wire beveling end and a core wire proximal end, the length of the core wire 1 is 2400mm, the beveling angle of the beveling end is 20+/-1 degrees, the outer diameter is 0.76+/-0.02 mm, the inner diameter is 0.20+/-0.04 mm, the wall thickness is 0.28+/-0.01 mm, and the beveling end is 2mm outwards without the coating along the direction of the core wire proximal end.
The reducing wire 2 is shaped into an equidistant conical spiral shape by an electrodeless reducing metal wire of SUS304 stainless steel, and comprises a reducing wire proximal end and a reducing wire distal end, wherein the pitch of the reducing wire 2 is 4.90mm, the cone apex angle is 45 degrees, the number of layers is 5, the diameter of the outermost layer of the cone is 50mm, and the diameter of the innermost layer is 10mm; the total length of the reducing wire 2 is 403.33mm, the diameter of the proximal end of the reducing wire 2 is 0.35 plus or minus 0.01mm, and the diameter of the distal end of the reducing wire 2 is 0.05 plus or minus 0.01mm after stepless diameter changing.
The outer side wire winding 3 is formed by winding a flat metal wire of SUS304 stainless steel, the surface of the outer side wire winding is coated with a PTFE (polytetrafluoroethylene) ultra-smooth coating, the section length of the flat wire is 0.255+/-0.02 mm, the thickness of the flat wire is 0.08+/-0.005 mm, the winding outer diameter is less than or equal to 0.86mm, and the winding pitch is 0.16+/-0.05 mm.
The balloon 4 is a TPU compliant balloon and comprises a balloon proximal end, a balloon middle section and a balloon distal end, wherein the balloon middle section is a straight thin-wall balloon body or a straight thin-wall balloon body in a natural state, and when the balloon is used, the balloon completely wraps a guide wire head end along with the three-dimensional spiral shape of the variable diameter wire 2, and the guide wire head end is the far end from the bevelled end of the core wire 1 to the outer wire winding 3; in use, pressure is applied to inflate balloon 4, and balloon 4 is "inflated" in a spiral shape as a whole. The outer diameter of the balloon is 1.0 plus or minus 0.1mm, the wall thickness is 0.02 plus or minus 0.01mm, and the length of the balloon is 410mm.
The core wire beveling end, the reducing wire proximal end, the outer wire winding proximal end and the balloon proximal end are bonded or welded; the variable diameter wire distal end, the outer wire winding distal end and the balloon distal end are bonded or welded; the outer wire winding covers the core wire beveling end and the reducing wire; the balloon wraps the beveled end of the core wire and the outer wire wrap.
Example 2
The aortic valve guide wire of the embodiment comprises a core wire 1, a reducing wire 2, an outer side winding wire 3 and a balloon 4; as shown in fig. 3.
The core wire 1 is a hollow catheter made of SUS304 stainless steel, the surface of the hollow catheter is coated with PTFE (polytetrafluoroethylene) ultra-smooth coating, the hollow catheter comprises a core wire beveling end and a core wire proximal end, the length of the core wire 1 is 2400mm, the beveling angle of the beveling end is 20+/-1 degrees, the outer diameter of the beveling end is 0.76+/-0.02 mm, the inner diameter of the beveling end is 0.20+/-0.04 mm, the wall thickness of the beveling end is 0.28+/-0.01 mm, and the beveling end is 2mm outwards along the direction of the core wire proximal end and is uncoated.
The reducing wire 2 is shaped into an equidistant conical spiral shape by an electrodeless reducing metal wire of SUS304 stainless steel, and comprises a reducing wire proximal end and a reducing wire distal end, wherein the pitch of the reducing wire 2 is 4.90mm, the cone apex angle is 45 degrees, the number of layers is 5, the diameter of the outermost layer of the cone is 50mm, and the diameter of the innermost layer is 10mm; the total length of the reducing wire 2 is 403.33mm, the diameter of the proximal end of the reducing wire 2 is 0.35 plus or minus 0.01mm, and the diameter of the distal end of the reducing wire 2 is 0.05 plus or minus 0.01mm after stepless diameter changing.
The outer side wire winding 3 is formed by winding a flat metal wire of SUS304 stainless steel, the surface of the outer side wire winding is coated with a PTFE (polytetrafluoroethylene) ultra-smooth coating, the section length of the flat wire is 0.255+/-0.02 mm, the thickness of the flat wire is 0.08+/-0.005 mm, the winding outer diameter is less than or equal to 0.86mm, and the winding pitch is 0.16+/-0.05 mm.
The balloon 4 is a compliant balloon made of TPU material and comprises a balloon proximal end, a balloon middle section and a balloon distal end, wherein in a natural state, the balloon middle section is a thin-wall balloon body or a tube body comprising a plurality of bulges and straight line sections, and when the balloon is used, the balloon completely wraps the wire guiding head end along with the three-dimensional spiral shape of the reducing wire 2, and the number of the bulges is 20; each protrusion has the same shape and length and the length is 10mm; the length of the straight line segment between each balloon is the same and is 10mm. When in use, the pressure is applied to enable the balloon 4 to be full and the 20 convex parts to be full and inflated, and the straight line sections are not full and inflated, so that the balloon 4 is in a spiral shape of a sugar-gourd string in whole.
The core wire beveling end, the reducing wire proximal end, the outer wire winding proximal end and the balloon proximal end are bonded or welded; the variable diameter wire distal end, the outer wire winding distal end and the balloon distal end are bonded or welded; the outer wire winding covers the core wire beveling end and the reducing wire; the balloon wraps the beveled end of the core wire and the outer wire wrap.
Example 3
The aortic valve guide wire of the embodiment comprises a core wire 1, a reducing wire 2, an outer side winding wire 3 and a balloon 4; as shown in fig. 4.
The core wire 1 is an SUS304 stainless steel hollow catheter, the surface of the core wire 1 is coated with PTFE (polytetrafluoroethylene) ultra-smooth coating, the core wire comprises a core wire beveling end and a core wire proximal end, the length of the core wire 1 is 2400mm, the beveling angle of the beveling end is 20+/-1 degrees, the outer diameter is 0.76+/-0.02 mm, the inner diameter is 0.20+/-0.04 mm, the wall thickness is 0.28+/-0.01 mm, and the beveling end is 2mm outwards without the coating along the direction of the core wire proximal end.
The diameter-variable wire 2 is shaped into a cylindrical spiral shape with variable screw pitch by an electrodeless diameter-variable metal wire of SUS304 stainless steel, and comprises a diameter-variable wire proximal end and a diameter-variable wire distal end, wherein the number of layers of the diameter-variable wire 2 is 5, the diameter is 30mm, the screw pitch of the 1 st circle is 0mm, the screw pitch of the 2 nd circle is 6mm, the screw pitch of the 3 rd circle is 5mm, and the screw pitch of the 6 th circle is 2mm in a descending way; the total length of the reducing wire 2 is 471.61mm, the diameter of the proximal end of the reducing wire 2 is 0.35 plus or minus 0.01mm, and the diameter of the distal end of the reducing wire 2 is 0.05 plus or minus 0.01mm after stepless diameter changing.
The outer side wire winding 3 is formed by winding a flat metal wire of SUS304 stainless steel, the surface of the outer side wire winding is coated with a PTFE (polytetrafluoroethylene) ultra-smooth coating, the section length of the flat wire is 0.255+/-0.02 mm, the thickness of the flat wire is 0.08+/-0.005 mm, the winding outer diameter is less than or equal to 0.86mm, and the winding pitch is 0.16+/-0.05 mm.
The balloon 4 is a compliant balloon made of TPU material and comprises a balloon proximal end, a balloon middle section and a balloon distal end, wherein in a natural state, the balloon middle section is a thin-wall balloon body or a tube body comprising a plurality of bulges and straight line sections, and when the balloon is used, the balloon completely wraps the wire guiding head end along with the three-dimensional spiral shape of the reducing wire 2, and the number of the bulges is 23; each protrusion has the same shape and length and the length is 10mm; the length of the straight line segment between each balloon is the same and is 10mm. When the balloon is used, the pressure is applied to enable the balloon 4 to be inflated, 23 convex parts are inflated, and a plurality of straight line sections are not inflated, so that the balloon 4 is inflated in a spiral shape of a sugar-gourd string.
The core wire beveling end, the reducing wire proximal end, the outer wire winding proximal end and the balloon proximal end are bonded or welded; the variable diameter wire distal end, the outer wire winding distal end and the balloon distal end are bonded or welded; the outer wire winding covers the core wire beveling end and the reducing wire; the balloon wraps the beveled end of the core wire and the outer wire wrap.
Comparative example 1
The aortic valve guide wire of this comparative example is similar to example 1, except that the reducing wire 2 is shaped as a straight wire, the proximal end diameter of the stepless reducing wire of SUS304 stainless steel is 0.35±0.01mm, the distal end diameter after stepless diameter reduction is 0.05±0.01mm, and the total length of the reducing wire is 230mm.
Comparative example 2
The aortic valve guide wire of this comparative example is similar to the comparative example except that the guide wire of this example has no balloon, the core wire is a solid catheter, the core wire and the variable diameter wire are one piece and are not welded, and the dimensions are the same as those of comparative example 1.
The aortic valve guide wires of the examples and the comparative examples are placed in an aortic valve vessel model, water with a certain pressure is added to enable the balloon to be filled, the balloon expansion size is the same, the same pushing force (10N) is applied to the guide wires, and the data of the simulation test of the aortic valve guide wires are shown in table 1.
The aortic valve guide wire of example 1 is not fixed in the balloon, the guide wire is tightly attached to the lower wall of the balloon after being pressed, the guide wire contacts with TPU medium of the balloon, the aortic valve guide wire presses the balloon and the ventricular wall, the contact area between the aortic valve guide wire and the aortic valve vascular model is small, the aortic valve vascular model can bear larger pressure, and the overall deformation of the aortic valve vascular model is small.
The aortic valve guide wire of example 2 is a "sugarcoated haws string", and the position of the guide wire in the balloon can be fixed when the guide wire is pressed, so that the guide wire is positioned in the middle of the balloon and can not cling to the lower wall of the balloon, the contact area between the guide wire of the aortic valve and the aortic valve vessel model is large, compared with example 1, the aortic valve vessel model can bear smaller pressure, the overall deformation of the aortic valve vessel model is very small, and the deformation degree is smaller than that of example 1.
The aortic valve guide wire of embodiment 3 is in a cylindrical spiral shape with a variable pitch, the end of the guide wire head is in a shape of a 'sugar-gourd string', the position of the guide wire in the balloon can be fixed when the guide wire is pressed, the guide wire is positioned in the middle of the balloon and cannot be clung to the lower wall of the balloon, the guide wire is contacted with TPU medium of the balloon, the guide wire of the aortic valve extrudes the balloon, the contact area between the guide wire and an aortic valve vascular model is large, compared with embodiment 1, the aortic valve vascular model can bear smaller pressure, the overall deformation of the aortic valve vascular model is very small, and the deformation degree is smaller than that of embodiment 1.
The aortic valve guide wire of comparative example 1, the reducing wire was linear, but not the three-dimensional spiral shape of the present invention, when the aortic valve vessel model was contacted by the balloon, the head end of the guide wire was first indirectly contacted to the ventricular wall by the balloon (TPU medium), and the contact area with the aortic valve vessel model was also increased due to the gradual increase of the applied pressure, the aortic valve vessel model was subjected to a greater pressure than in example 1, and the overall deformation degree of the aortic valve vessel model was moderate.
The aortic valve guide wire of comparative example 2, without a balloon, when the aortic valve vessel model was contacted by the balloon, the head end of the guide wire (SUS 304 stainless steel medium) was directly contacted to the ventricular wall, and the contact area with the aortic valve vessel model was also larger and larger due to the gradual increase of the applied pressure, the contact area range was consistent with comparative example 1, but since the hardness of the SUS304 stainless steel medium was much greater than that of the TPU medium, the pressure born by the aortic valve vessel model was increased, and the overall deformation degree of the aortic valve vessel model was large.
The present invention is not limited to the above-mentioned embodiments, and any changes or substitutions that can be easily understood by those skilled in the art within the technical scope of the present invention are intended to be included in the scope of the present invention.
Claims (10)
1. An aortic valve guide wire is characterized by comprising a core wire, a reducing wire, an outer side winding wire and a balloon;
the core wire is a hollow catheter and comprises a core wire beveling end and a core wire proximal end;
the reducing wire is shaped into a spiral shape by a stepped reducing wire or an electrodeless reducing wire, and comprises a reducing wire proximal end and a reducing wire distal end;
the outer wire wrap includes an outer wire wrap proximal end and an outer wire wrap distal end;
the balloon comprises a balloon proximal end, a balloon middle section and a balloon distal end;
the core wire beveling end, the reducing wire proximal end, the outer wire winding proximal end and the balloon proximal end are bonded or welded; the variable diameter wire distal end, the outer wire winding distal end and the balloon distal end are bonded or welded;
the outer wire winding covers the core wire beveling end and the reducing wire;
the balloon wraps the beveled end of the core wire and the outer wire wrap.
2. The aortic valve guide wire according to claim 1, wherein the beveled end of the core wire has a beveled angle of 20±1°.
3. The aortic valve guide wire according to claim 2, wherein the proximal diameter of the reducing wire is 0.35 ± 0.01mm, the distal diameter of the reducing wire is 0.05 ± 0.01mm, and the length of the reducing wire is 212.29-409.43mm.
4. The aortic valve guide wire according to claim 3, wherein the helical pitch is 1.45-8.45mm, the number of helical layers is 4-5, and the diameter is 10-50mm.
5. The aortic valve guide wire according to claim 1, wherein the outer wire wrap is formed from a round wire having a diameter of 0.08 ± 0.005mm, a wrap outer diameter of ∈0.86mm, and a wrap pitch of 0.16 ± 0.05mm.
6. The aortic valve guide wire according to claim 1, wherein the outer wire is wound from a flat wire having a cross-sectional length of 0.255 ± 0.02mm, a thickness of 0.08 ± 0.005mm, a winding outer diameter of ∈0.86mm, and a winding pitch of 0.16 ± 0.05mm.
7. The aortic valve guide wire according to claim 1, wherein the middle section of the balloon is a straight thin-walled balloon body or tube body, the outer diameter of the balloon is 1.0+/-0.1 mm, the wall thickness is 0.02+/-0.01 mm, and the length of the balloon is 220-480mm.
8. The aortic valve guide wire according to claim 1, wherein the balloon middle section is a thin-walled balloon body or tube body comprising a plurality of bulges and straight line sections, the shape and the length of the bulges are the same, and the length is 10-15mm; the length of the straight line segments is the same and is 5-10mm.
9. The aortic valve guide wire according to claim 1, wherein the core wire and the outer wire wrap surfaces are coated with a polytetrafluoroethylene ultra-slip coating.
10. The aortic valve guide wire according to claim 1, wherein the reducing wire and the outer wire wrap include a visualization material therebetween.
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| CN202410179333.9A CN117717694B (en) | 2024-02-18 | 2024-02-18 | Aortic valve guide wire |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202410179333.9A CN117717694B (en) | 2024-02-18 | 2024-02-18 | Aortic valve guide wire |
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| CN117717694B CN117717694B (en) | 2024-04-16 |
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|---|---|---|---|---|
| US6156046A (en) * | 1997-11-07 | 2000-12-05 | Prolifix Medical, Inc. | Methods and systems for treating obstructions in a body lumen |
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| CN207384584U (en) * | 2018-01-08 | 2018-05-22 | 上海普实医疗器械科技有限公司 | A kind of orientable mitral balloon seal wire |
| CN113827845A (en) * | 2021-10-22 | 2021-12-24 | 中国医学科学院阜外医院 | Wire guide device with improved supporting effect |
| US20230149668A1 (en) * | 2021-11-15 | 2023-05-18 | Aidan Raney | Three-dimensional protective device |
| CN219355028U (en) * | 2022-12-14 | 2023-07-18 | 聚辉医疗科技(深圳)有限公司 | Core wire structure and micro-guide wire |
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2024
- 2024-02-18 CN CN202410179333.9A patent/CN117717694B/en active Active
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6156046A (en) * | 1997-11-07 | 2000-12-05 | Prolifix Medical, Inc. | Methods and systems for treating obstructions in a body lumen |
| GB0304989D0 (en) * | 2003-03-05 | 2003-04-09 | Andrews Lars | Aortic catheter |
| CN207384584U (en) * | 2018-01-08 | 2018-05-22 | 上海普实医疗器械科技有限公司 | A kind of orientable mitral balloon seal wire |
| CN113827845A (en) * | 2021-10-22 | 2021-12-24 | 中国医学科学院阜外医院 | Wire guide device with improved supporting effect |
| US20230149668A1 (en) * | 2021-11-15 | 2023-05-18 | Aidan Raney | Three-dimensional protective device |
| CN219355028U (en) * | 2022-12-14 | 2023-07-18 | 聚辉医疗科技(深圳)有限公司 | Core wire structure and micro-guide wire |
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