阅读说明：本技术 一种具有监测血压功能的医用导丝 (Medical guide wire with blood pressure monitoring function ) 是由 杨奔 于 2021-07-30 设计创作，主要内容包括：本发明公开了一种具有监测血压功能的医用导丝,涉及医用导丝领域,本发明的技术方案是：包括导丝本体和光学传感器；所述导丝本体的远端端部采用X射线显影材质,所述导丝本体的远端端部的侧壁设有测量用的开口,所述开口对应的所述导丝本体内部设置所述光学传感器。具有非常好的指示性能,显影位置直观的表示出传感器的位置,并且通过壁厚更薄、内腔更大的远端外层管设计,密度变化的切缝和股数变化的弹簧件,能够使本方案中的导丝兼顾远端的扭转柔韧性能和近端的推送支撑操控性能。(The invention discloses a medical guide wire with a blood pressure monitoring function, and relates to the field of medical guide wires, wherein the technical scheme of the invention is as follows: comprises a guide wire body and an optical sensor; the far-end of the guide wire body is made of X-ray developing materials, an opening for measurement is formed in the side wall of the far-end of the guide wire body, and the optical sensor is arranged inside the guide wire body and corresponds to the opening. The guide wire has good indicating performance, the position of the sensor is visually represented at the developing position, and the guide wire in the scheme can give consideration to the twisting flexibility performance of the far end and the pushing support control performance of the near end through the design of the far end outer layer tube with thinner wall thickness and larger inner cavity, and the cutting seam with variable density and the spring part with variable strand number.)

1. The medical guide wire with the function of monitoring blood pressure is characterized by comprising a guide wire body and an optical sensor (5);

the far-end portion (6) of the guide wire body is made of X-ray developing materials, an opening (3) is formed in the side wall of the far-end portion (6) of the guide wire body, and the optical sensor (5) is arranged in the guide wire body corresponding to the opening (3).

2. The medical guide wire with the function of monitoring blood pressure as claimed in claim 1, wherein: the guidewire body comprises a distal section (2) and a proximal section (1), wherein the inner diameter of the distal section (2) is larger than that of the proximal section (1).

3. The medical guide wire with the function of monitoring blood pressure as claimed in claim 2, wherein: the proximal section (1) and the distal section (2) are made of the same material.

4. The medical guide wire with the function of monitoring blood pressure as claimed in claim 3, wherein: the proximal section (1) and the distal section (2) are made of nickel titanium alloy.

5. The medical guide wire with the function of monitoring blood pressure as claimed in claim 1, wherein: the distal section (2) is distributed with a plurality of cutting seams (9).

6. The medical guide wire with the function of monitoring blood pressure as claimed in claim 5, wherein: the distribution density of the cutting seams (9) is gradually reduced from the far end to the near end.

7. The medical guide wire with the function of monitoring blood pressure as claimed in claim 1, wherein: the distal section (2) has a spring element (4) disposed therein.

8. The medical guide wire with the function of monitoring blood pressure as claimed in claim 7, wherein: the wire harness of the optical sensor (5) extends through the spring element (4) into the proximal section (1).

9. The medical guide wire with the function of monitoring blood pressure as claimed in claim 8, wherein: the spring element (4) comprises a proximal multi-strand spiral section (7) and a distal few-strand spiral section (8).

Technical Field

The invention relates to the field of medical guide wires, in particular to a medical guide wire with a blood pressure monitoring function.

Background

An interventional decision which is obtained based on an intravascular manometry technology and can be used for guiding a coronary stenosis subject is definitely recommended in an ACC/AHA coronary intervention guide in 2011, which is a powerful supplement to the traditional coronary angiography evaluation method and lays a foundation for realizing individualized and accurate treatment and tamping of a coronary stent. The so-called Fractional Flow Reserve (FFR) of the coronary artery is in fact the ratio of the blood pressure distal and proximal to the stenosis in the vessel.

The existing solutions have the following drawbacks:

most of FFR guide wires at the present stage are designed by spring winding, an opening for collecting blood pressure by a sensor is not arranged at the appearance part of the tip of the guide wire, and the opening is usually away from the tip of the guide wire by a certain distance, so that the guide wire enters the body, the position of the guide wire is observed by radiography, and an operator needs to judge the relative position of the opening of the sensor in a target blood vessel according to the distance between the opening of the sensor and the tip of the guide wire in the instruction of different products. If the developing material is embedded near the opening, although the accuracy of the position of the guide wire sensor in the positioning of the blood vessel can be improved, the process realization difficulty of guide wire processing can be improved. The materials of the proximal end and the distal end of the FFR guide wire are different (for example, the proximal end is 304 stainless steel, and the distal end is a nickel-titanium alloy material), and the welding process difficulty is high due to the difference of the material properties and the melting point.

Disclosure of Invention

In order to solve the technical problems, the invention provides a medical guide wire with a blood pressure monitoring function, which has excellent indicating performance, the position of a sensor is visually shown at a developing position, and the guide wire in the scheme can give consideration to the torsion flexibility performance of a far end and the pushing and supporting control performance of a near end by the aid of a far end outer layer tube design with thinner wall thickness and larger inner cavity, a kerf with variable density and a spring part with variable strand number.

The technical scheme adopted by the invention for solving the technical problems is as follows: a medical guide wire with a blood pressure monitoring function comprises a guide wire body and an optical sensor;

the far-end of the guide wire body is made of X-ray developing materials, an opening is formed in the side wall of the far-end of the guide wire body, and the optical sensor is arranged in the guide wire body corresponding to the opening.

The material is developed through the distal end portion with the X ray with the seal wire body to this scheme has set up optical sensor at the distal end portion of seal wire body, and the structure of X ray development material is located same department with optical sensor's position promptly, consequently gets into internal back at the seal wire, observes the position of seal wire distal end portion through the radiography, can audio-visually know sensor open-ended position, and can not cause the interference to the position of sensor.

Preferably, the guidewire body comprises a distal segment and a proximal segment, the distal segment having an inner diameter greater than the inner diameter of the proximal segment. I.e., thinner wall thickness, of the distal section, may provide greater flexibility.

Preferably, the proximal section and the distal section are made of the same material. The same material has the same physical property, and the welding process difficulty can be reduced.

Preferably, the proximal and distal sections are of nitinol. The nickel-titanium alloy has super elasticity and memory performance, and has excellent pushing performance and torsion overload performance.

Preferably, the distal section is distributed with a plurality of slits. The flexibility of the guide wire can be improved by arranging the cutting seam, and the pushing performance and the twisting performance of the guide wire are improved.

Preferably, the slits are distributed with a decreasing density from the distal end to the proximal end. The more dense the lancing, the better the flexibility of the guide wire, and the less dense the lancing closer to the near end, the scheme of combining the torsion flexibility of the far end and the pushing support control performance of the near end can be adopted.

Preferably, the distal section has a spring member built into it. The flexibility of the distal section can be improved by the spring element, the pushing can be better performed, and the spring element can be better arranged due to the larger inner diameter of the distal section.

Preferably, the wiring harness of the optical sensor extends through the spring member inwardly toward the proximal section. The wiring harness of the optical sensor is better arranged.

Preferably, the spring member includes a proximal multi-stranded coil section and a distal few-stranded coil section. The more the strands are, the lower the flexibility of the spring is, the better flexibility can be achieved by adopting a few-strand spiral section at the far end, and the twisting flexibility performance of the far end and the pushing support control performance of the near end are considered.

The invention has the beneficial effects that:

the technical scheme has good indicating performance, the position of the sensor is visually represented at the developing position, and the guide wire in the technical scheme can give consideration to the twisting flexibility of the far end and the pushing support control performance of the near end by the aid of the design of the far end outer layer pipe with thinner wall thickness and larger inner cavity and the spring part with variable density of the cutting seam and variable strand number.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments will be briefly introduced below, and it is obvious that the drawings in the following description are only seven of the present invention, and it is obvious for those skilled in the art that other drawings can be obtained based on these drawings without creative efforts.

FIG. 1 is a schematic structural diagram of an embodiment of the present invention;

FIG. 2 is a schematic view of a distal segment of an embodiment of the present invention;

FIG. 3 is a schematic view of a guidewire body according to an embodiment of the invention;

FIG. 4 is a schematic view of a spring member according to an embodiment of the present invention;

FIG. 5 is a schematic view of the guidewire body and spring member assembly of an embodiment of the present invention;

FIG. 6 is a schematic view of an embodiment of the present invention with an optical sensor and spring member assembled;

FIG. 7 is a schematic view of an embodiment of the present invention with the distal tip assembled;

the sensor comprises a proximal section 1, a distal section 2, an opening 3, a spring element 4, an optical sensor 5, a distal end 6, a multi-strand spiral section 7, a few-strand spiral section 8 and a cut 9.

Detailed Description

For the purpose of enhancing the understanding of the present invention, the present invention will be described in further detail with reference to the accompanying drawings and examples, which are provided for the purpose of illustration only and are not intended to limit the scope of the present invention.

Examples

As shown in fig. 1, the present embodiment includes a guidewire body and an optical sensor 5.

The far-end part 6 of the guide wire body is made of X-ray developing materials, an opening 3 for measurement is formed in the side wall of the far-end part 6 of the guide wire body, and the optical sensor 5 is arranged in the guide wire body corresponding to the opening 3.

In the scheme, the distal end part 6 of the guide wire body is made of the X-ray developing material, and the optical sensor 5 is arranged at the distal end part 6 of the guide wire body, namely the structure of the X-ray developing material and the position of the optical sensor 5 are located at the same position, so that after the guide wire enters the body, the position of the distal end part 6 of the guide wire is observed through radiography, and the position of the sensor opening 3 can be intuitively known.

As shown in fig. 3, the guidewire body comprises a distal segment 2 and a proximal segment 1, wherein the inner diameter of the distal segment 2 is larger than that of the proximal segment 1. I.e. a thinner wall thickness of the distal section 2, may provide better flexibility. The proximal section 1 and the distal section 2 are made of the same material. The same material has the same physical property, and the welding process difficulty can be reduced. The proximal section 1 and the distal section 2 are made of nickel titanium alloy. The nickel-titanium alloy has super elasticity and memory performance, and has excellent pushing performance and torsion overload performance.

As shown in fig. 2, the distal segment 2 is provided with a plurality of slits 9. The arrangement of the cutting seam 9 can improve the flexibility of the guide wire and improve the pushing performance and the twisting performance of the guide wire. The slits 9 can be embodied as spiral slits or as slits which are staggered across the cross-section. The slits 9 are distributed with a decreasing density from the distal end to the proximal end. The more the cutting slits 9 are, the better the flexibility of the guide wire is, and the scheme that the density of the cutting slits 9 is smaller when the cutting slits are closer to the near end is adopted, so that the twisting flexibility performance of the far end and the pushing support control performance of the near end can be considered.

As shown in fig. 4, the distal section 2 has a spring element 4 embedded therein. The specific spring element 4 and the light sensor are located in the distal section 2, the spring element 4 is located in the area other than the opening 3, and the sensor is located in the area of the opening 3. The flexibility of the distal section 2 can be increased by the spring element 4, so that a better pushing action can be achieved, and a larger inner diameter of the distal section 2 can also better accommodate the spring element 4. The spring member 4 includes a proximal multi-stranded coil section 7 and a distal few-stranded coil section 8. The more the strands are, the lower the flexibility of the spring is, the better flexibility can be achieved by adopting the few-strand spiral section 8 at the far end, and the twisting flexibility performance of the far end and the pushing support control performance of the near end are considered. Specifically, a double helix structure at the proximal end and a single helix structure at the distal end.

As shown in fig. 5 and 6, the wire harness of the optical sensor 5 extends through the spring element 4 into the proximal section 1. The wiring harness of the optical sensor 5 is better arranged.

The technical scheme has good indicating performance, the position of the sensor is visually represented at the developing position, and the guide wire in the technical scheme can give consideration to both the twisting flexibility performance of the far end and the pushing support control performance of the near end through the far end section 2 with thinner wall thickness and larger inner diameter, the cutting seam 9 with variable density and the spring part 4 with variable strand number.

The manufacturing method of the guide wire in the scheme is as follows:

1) laser cutting of the hypotube design: carrying out laser cutting on the nickel-titanium alloy tube of the distal end section 2;

the laser cutting design, in which the density between the slits 9 is gradually decreased from the distal end to the proximal end, can achieve the desired flexibility at the distal end as compared to the proximal end, as shown below.

2) Welding the distal section 2 and the proximal section 1, butting two nickel titanium tubes, and welding the butting area circumferentially by laser welding.

3) The design that the spring part 4 is divided into two sections, the proximal end is a bifilar spiral section, and the distal end is a single spiral section is prepared, so that the design that the distal end is more flexible than the proximal end can be realized.

4) The spring element 4 is inserted into the cavity of the nickel-titanium alloy distal section 2 from the distal end, and after the assembly is completed, the distal inner cavity of the distal section 2 is partially reserved as a subsequent sensor placement area.

5) The optical sensor 5 is inserted from the distal end, and the sensor is placed in the area corresponding to the distal end opening 3.

6) And placing the end part of the guide wire on the end surface of the far end of the system, and welding to finish the preparation of the guide wire. The tip of the guide wire is made of X-ray-opaque material and can be developed under X-ray.

7) After the preparation of the guide wire is completed, a receiver is connected to the proximal end of the guide wire, and a wiring harness of the optical sensor 5 extends to the proximal end through the spring part 4 and the cavity of the proximal end section 1 and is used for receiving the pressure signal collected by the distal end sensor.

In the scheme, the optical sensor is of a type FOP-M200.

The above embodiments should not limit the present invention in any way, and all technical solutions obtained by using equivalent alternatives or equivalent transformations fall within the protection scope of the present invention.