Pressure Guide Wire

Abstract

The invention relates to a pressure guide wire which comprises an insertion portion and an operation portion, wherein the insertion portion comprises a mandrel, a distal-end protective sleeve wrapping the distal end portion of the mandrel, a proximal-end protective sleeve wrapping the proximal end portion of the mandrel, an intermediate ring disposed between the distal-end protective sleeve and the proximal-end protective sleeve, which is fixedly sleeved on the mandrel and the outer surface of which is provided with a groove, and a pressure sensor disposed in the groove of the intermediate ring and connected with a plurality of sensing wires, which extends between the proximal-end protective sleeve and the mandrel and the other end of which is connected to the operation portion. The operation portion is used to transmit signals of the sensor to an external display device. The pressure guide wire can monitor the pressure change in the lumen accurately and in real time, and the sensing wires is wrapped by the proximal-end protective sleeve, so that the guide wire is good in flexibility and the durability, and the pressure guide wire has a smooth outer wall and is excellent in safety.

Claims

1. A pressure guide wire, comprising: an insertion portion and an operation portion, wherein the insertion portion comprises a mandrel: a distal-end protective sleeve wrapping a distal end portion of the mandrel, a proximal-end protective sleeve wrapping a proximal end portion of the mandrel, an intermediate ring disposed between the distal-end protective sleeve and the proximal-end protective sleeve, which is fixedly sleeved on the mandrel, and an outer surface of which is provided with a groove, and, a pressure sensor disposed in the groove of the intermediate ring and connected with a plurality of sensing wires, which extends between the proximal-end protective sleeve and the mandrel, and other end of which is connected to the operation portion, the operation portion is connected to the proximal end of the insertion portion, and is used to transmit signals of the sensor to an external display device.

2. The pressure guide wire as claimed in claim 1, wherein the operation portion transmits the signal of the pressure sensor to the external display device by wire or wireless means.

3. The pressure guide wire as claimed in claim 1, wherein the portions of the plurality of sensing wires located between the proximal-end protective sleeve and the mandrel do not cross each other.

4. The pressure guide wire as claimed in claim 3, wherein the portions of the plurality of sensing wires located between the proximal-end protective sleeve and the mandrel is uniformly distributed along a circumferential direction on the surface of the mandrel.

5. The pressure guide wire as claimed in claim 3, wherein the portions of the plurality of sensing wires located between the proximal-end protective sleeve and the mandrel is spirally wound on the surface of the mandrel.

6. The pressure guide wire as claimed in claim 1, wherein the proximal-end protective sleeve is a heat shrink tube, and the heat shrink tube is made of a material selected from fluoropolymer, polyurethane, and nylon elastomer.

7. The pressure guide wire as claimed in claim 6, wherein the heat shrink tube is made of a fluorinated ethylene propylene copolymer.

8. The pressure guide wire as claimed in claim 1, wherein an outer diameter of the distal end of the intermediate ring and the proximal end of the distal-end protective sleeve are substantially same and an outer diameter of the proximal end of the intermediate ring and the distal end of the proximal-end protective sleeve are substantially same.

9. The pressure guide wire as claimed in claim 1, wherein the intermediate ring is made of a metal material.

10. The pressure guide wire as claimed in claim 1, wherein the distal end of the proximal-end protective sleeve and/or the distal-end protective sleeve is further wrapped with a functional coating layer, which is a hydrophilic coating, a lubricating coating or a bio-coating.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments:

[0028] FIG. 1 is the schematic structural view of the guide wire portion of the pressure guide wire according to the present invention,

[0029] FIG. 2 is the cross-sectional view taken along line A-A of FIG. 1,

[0030] FIG. 3 is the schematic structural view of the sensing wire spirally wound on the mandrel according to the present invention;

[0031] FIG. 4 is the schematic structural view of the intermediate ring according to the present invention;

[0032] FIG. 5 is the schematic structural view showing the connection mode of the pressure guide wire and the display device according to the present invention.

[0033] FIG. 6 is the schematic structural view showing another connection mode of the pressure guide wire and the display device according to the present invention.

[0034] The component numbers are as follows: [0035] 1distal-end protective sleeve [0036] 2intermediate ring [0037] 21groove [0038] 3proximal-end protective sleeve [0039] 4mandrel [0040] 5pressure sensor [0041] 51sensing wire [0042] 6operation portion [0043] 7display device

DETAILED DESCRIPTION OF THE INVENTION

[0044] Preferred embodiments of the present invention will now be described in detail in conjunction with the drawings. Although the description of the present invention will be described in conjunction with the various embodiments, it is not intended that the features of the invention are limited to the embodiments. Rather, the invention is described in connection with the embodiments so as to cover other alternatives or modifications that are possible in the embodiments of the invention. In order to provide a thorough understanding of the present invention, many specific details are included in the following description. The invention may also be practiced without these details. In addition, some specific details are omitted from the description in order to avoid confusion or blur the focus of the present invention.

[0045] In addition, upper, lower, left, right, top, and bottom used in the following description are set to better describe the preferred embodiment of the present invention. It should not be construed as limiting the invention.

[0046] As used herein, proximal end or tail end is the end closest to the physician in use. The distal end or front end is the end of the body cavity that is the farthest from the entrance, that is, the end farthest from the doctor or the insertion end.

[0047] In the following drawings, the full length of the guide wire is not shown. The length of the guide wire can be changed according to the requirements, but typically the length of the guide wire is in the range of 30 to 800 centimeters (cm).

[0048] The technical solution of the present invention is shown in FIGS. 1 to 6, the guide wire comprises an insertion portion and an operation portion 6. The insertion portion comprises a mandrel 4, a distal-end protective sleeve 1 wrapping the distal end portion of the mandrel 4, a proximal-end protective sleeve 3 wrapping the proximal end portion of the mandrel 4, an intermediate ring 2 disposed between the distal-end protective sleeve 1 and the proximal-end protective sleeve 3, which is fixedly sleeved on the mandrel 4 and the outer surface of which is provided with a groove 21, and, a pressure sensor 5 disposed in the groove 21 of the intermediate ring 2, which connects with a plurality of sensing wires 51 extending between the proximal-end protective sleeve 3 and the mandrel 4, wherein the other end of the sensing wires 51 is connected to the operation portion 6. The operation portion 6 is connected to the proximal end of the insertion portion, which is used to transmit signals of the sensor to an external display device 7.

[0049] The present invention can make the pressure sensor 5 directly contacts the liquid in the human body's lumen by fixing the pressure sensor 5 in the groove 21 of the intermediate ring 2, so that the pressure change in the lumen can be monitored accurately and in real time. The sensing wires 51 is wrapped by the proximal-end protective sleeve 3 without adhesive between the proximal-end protective sleeve 3 and the mandrel 4, thus the flexibility of the guide wire is good, the guide wire will not crack when bent, and the durability is good. In addition, the proximal-end protective sleeve 3 is used to wrap the sensing wires 51 entirely, so the processing is simple and the outer wall of the guide wire is smooth, which can avoid scratching human organs and has good safety.

[0050] Further, the operation portion 6 transmits the signal of the pressure sensor 5 to the external display device 7 by wire or wireless means. When the wired connection method shown in FIG. 5 is adopted, the operation portion 6 is provided with a connection port, such as a common USB interface or a PS/2 interface. and the external display device 7 may be a mobile phone, a tablet computer or a computer, etc., by which an APP or a software program as a display program is loaded, and the external display device 7 and the operation portion 6 can be connected by a data cable.

[0051] Further, the external display device 7 and the operation portion 6 can also be connected by a wireless connection as shown in FIG. 6. At this time, a wireless communication module needs to be provided in the operation portion 6 for transmitting the signal of the pressure sensor 5 to the external display device. 7. It is also necessary to provide a power module for supplying power to the pressure sensor and the wireless communication module. Correspondingly, the external display device 7 also needs to be provided with a wireless communication module for receiving the signal of the pressure sensor 5.

[0052] Further, the type of the pressure sensor 5 is not specifically limited in the present invention. The pressure sensor 5 may include a semiconductor (such as a silicon wafer) pressure sensor, a piezoelectric pressure sensor, an optical fiber or an optical pressure sensor, and a Perot-type (Fabry-Perot type) pressure sensor, ultrasonic migrator and/or ultrasonic pressure sensor, magnetic pressure sensor, solid state pressure sensor, etc., or any other suitable type of pressure sensor.

[0053] Further, it should be avoided as much as possible that the plurality of sensing lines 51 have cross-contact with each other in order to fully ensure the measurement accuracy of the pressure sensor 5. Otherwise, the signals may interfere with each other and affect the accuracy of the measurement results of the pressure sensor 5. Therefore, it is preferable that the portions of the sensing wires 51 located between the proximal-end protective sleeve 3 and the mandrel 4 do not cross each other in the present invention.

[0054] More preferably, the portions of the plurality of sensing wires 51 located between the proximal-end protective sleeve 3 and the mandrel 4 may be uniformly distributed along the circumferential direction on the surface of the mandrel 4 as shown in FIG. 2, so that the sensing wires 51 is the farthest distance from each other, and signal interference between each other can be avoided as much as possible. Preferably, as shown in FIG. 3, the sensing wires 51 can also be spirally wound on the surface of the mandrel 4. The flexibility of the guide wire can be better maintained by spirally winding the sensing wires 51 on the mandrel 4, and the sensing wires 51 does not limit the movement of the guide wire when the guidewire is bent.

[0055] Further, the pressure sensor 5 can be fixed in the groove 21 of the intermediate ring 2 by any known means in the prior art, for example, it can be adhered by adhesive, or fixed by a physical structure in the groove 21 of the intermediate ring 2, which may be means of engagement or partial wrapping commonly used in the prior art as long as it does not affect the pressure sensor's monitoring of the pressure.

[0056] Further, the proximal-end protective sleeve 3 is a heat shrink tube. The plurality of sensing wires 51 are fixed between the proximal-end protective sleeve 3 and the mandrel 4 while the proximal-end protective sleeve 3 shrinks thermally on the surface of the mandrel 4. There is no adhesive between the proximal-end protective sleeve 3 and the mandrel 4, which will not affect the flexibility of the pressure guide wire and the surface of the guide wire will not crack due to bending during use. Thereby, the service life of the guide wire becomes long, the processing of the guide wire is simple, and the surface of the guide wire is smooth, which has no risk of scratching the inner wall of the human body's cavity.

[0057] More preferably, the heat shrink tube may be made of a material selected from fluoropolymer, polyurethane, and nylon elastomer. All of the above materials have good bioaffinity. In the present invention, preferably, the heat shrink tube is made of a fluorinated ethylene propylene copolymer (FEP). FEP has low heat shrinking temperature, which can avoid damage to the pressure sensor due to excessive heat shrinking temperature during the production process. Moreover, FEP has a smaller surface friction than other fluoropolymers, and the prepared guide wire has better insertability.

[0058] Further, the distal-end protective sleeve 1 may be a spiral metal spring coil or a polymer sleeve, which may be made of one or more materials selected from fluoropolymer, polyurethane or nylon elastomer.

[0059] Preferably, the outer diameter of the distal end of the intermediate ring 2 and the proximal end of the distal-end protective sleeve 1 are substantially the same, and the outer diameter of the proximal end of the intermediate ring 2 and the distal end of the proximal-end protective sleeve 3 are substantially the same, that is, the transition among the distal-end protective sleeve 1, the intermediate ring 2 and the proximal-end protective sleeve 3 is smooth, thereby ensuring the flatness and smoothness of the entire surface of the guide wire, and further reducing the possibility of scratching the inner wall of the human body's cavity.

[0060] Further, the intermediate ring 2 with the pressure sensor 5 is as shown in FIG. 4. The ratio of length and diameter of the intermediate ring is not particularly limited, which can be adjusted according to the size of the guide wire and the pressure sensor 5. The intermediate ring 2 can be made of a rigid material with a certain hardness, so that the pressure sensor 5 can maintain the original shape when the guide wire is bent, and does not deform as the guide wire is bent, thereby ensuring the measurement accuracy of the pressure sensor 5. More preferably, the length of the groove 21 in the axial direction of the guide wire is greater than the length of the pressure sensor 5, the pressure sensor 5 can be fixed proximal-end protective sleeve without contacting directly with the proximal-end protective sleeve 3 when the pressure sensor 5 is fixed in the groove 21 of the intermediate ring 2, which can avoid the damage on proximal-end protective sleeve the pressure sensor 5 due to excessive temperature when the proximal-end protective sleeve 3 shrinks thermally on the surface of the mandrel 4.

[0061] Preferably, the intermediate ring 2 is a rigid material with a certain hardness. Preferably, the intermediate ring 2 is made of a metal material since the intermediate ring 2 is directly in contact with the heat shrink tube. For example, stainless steel, nickel-titanium alloy, etc. can be used, which can withstand a higher heat shrinking temperature without deformation. More preferably, the intermediate ring 2 may be made of a stainless steel material, which has good developability under X-ray, and helps the operator to accurately locate the position of the pressure sensor 5.

[0062] Further, the mandrel 4 is a solid structure made of a metal material, which is not particularly limited. The metal materials commonly used in the field can be selected, for example, various metal materials such as stainless steel (for example, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS429, SUS430F, SUS302, etc.), and alloy materials exhibiting pseudo-elasticity (including super-elastic alloy) can be used, in which super-elastic alloy is preferred. Since the super-elastic alloy is relatively soft and resilient, which is difficult to bend. Therefore, the front end portion of the super-elastic alloy has sufficient bending flexibility and elastic recovery capability when it is used as the guide wire of the mandrel 4, which can improve the insertion performance to a complex, curved lumen, and can obtain better operability. The guide wire does not cause permanent bending deformation due to the excellent elastic recovery ability of the guide wire even if the guide wire undergoes repeated bending deformation, so it is possible to prevent the guide wire from being deteriorated in operability due to bending during use.

[0063] Further, the super-elastic alloy is preferably a nickel-titanium alloy. The use of the nickel-titanium alloy as the guide wire of the mandrel 4 has excellent insertion performance, torque transmission property, and further has good operability. At the same time, it has good flexibility and resilience at the distal end, furthermore the trackability and safety of the lumen are improved, and the risk of puncturing the inner wall of the lumen is further reduced.

[0064] Further, although the guide wire in the drawings of the present invention is a straight guide wire, the pressure guide wire may also be an elbow guide wire.

[0065] Further, the distal end of the proximal-end protective sleeve and/or the distal-end protective sleeve is further wrapped with a functional coating layer. The functional coating layer is a hydrophilic coating, a lubricating coating or a bio-coating. The hydrophilic coating attracts water molecules to form a gel-like surface on its surface, reducing resistance when the lead wire is inserted, while further enhancing the biocompatibility of the guide wire and the body tissue. There is no specific limitation on the hydrophilic coating material, and the coating may be formed of a material with low friction resistance. For example, it is preferably made of polyvinyl alcohol, polyvinylpyrrolidone, polyethylene glycol, polyacrylamide, polyacrylic acid, sodium polyacrylate, poly (2-hydroxyethyl methacrylate), maleic anhydride copolymer, ethylene-vinyl alcohol copolymer, 2-methacryloyloxyethyl phosphate choline or its copolymer, (2-hydroxyethyl methacrylate)-styrene block copolymer, one or more of various synthetic polypeptides, collagens, hyaluronates, and one or more of the cellulose-based copolymers.

[0066] The type of the lubricating coating is not specifically limited as long as the friction force of the guide wire surface can be reduced and the insertion performance of the guide wire can be improved. Specifically, the fluoropolymer coating can be selected.

[0067] There is no specific limitation on the type of the bio-coating, and a suitable coating layer can be selected according to the needs of the patient's condition. For example, antithrombotic agents such as heparin-quaternary ammonium complexes, antimicrobial agents such as various silver compounds, quaternary ammonium compounds such as benzalkonium chloride, phenol derivatives such as thymol, and antibiotics such as gentamicin, nourishment Ofloxacin, and rifamycin.

[0068] The pressure guide wire of the present invention is preferably applied in non-vascular fields, such as urinary, digestive, respiratory, and reproductive systems. Since the non-vascular system lumen is wider than the blood vessel, the pressure sensor 5 can be fully prevented from directly contacting the inner wall of the cavity in the human body under the presence of an endoscope, and it is not necessary to dispose the pressure sensor 5 inside the mandrel 4. Therefore, the size of the guide wire can be reduced, and the measurement accuracy of the pressure sensor 5 can also be improved.

[0069] In summary, the present invention can make the pressure sensor directly contact the liquid in the human body's lumen by fixing the pressure sensor in the groove of the intermediate ring, so that the pressure change in the lumen can be monitored accurately and in real time. The sensing wires is wrapped by the proximal-end protective sleeve, and there is no adhesive between the proximal-end protective sleeve and the mandrel, so the flexibility of the guide wire is good, the guide wire will not crack when bent, and the durability is good. In addition, the entire proximal-end protective sleeve is used to wrap the sensing wires, so that the processing of the guide wire is simple and the outer wall of the guide wire is smooth, which can avoid scratching human organs and has good safety.

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