A pressure guide wire

Abstract

The present disclosure provides a pressure guide wire, comprising: a guide wire body comprising a tube wall and an inner cavity defined by the tube wall; a first sensor assembly and a second sensor assembly are sequentially arranged along a proximal end of the guide wire body to a distal end of the guide wire body, and the first sensor assembly and the second sensor assembly are arranged in the inner cavity; the first sensor assembly and the second sensor assembly each comprise a pressure sensor and a lead wire connected with the pressure sensor and extending from the pressure sensor towards the proximal end of the guide wire body; and a pressure sensing hole is arranged on the tube wall at the position of the pressure sensor. The pressure guide wire of the present disclosure can realize pressure measurement at two positions and is convenient to operate.

Description

Technical Field

[0001] This disclosure relates to a pressure guidewire. Background Technology

[0002] Structural heart surgery is one of the important interventional treatments for structural heart disease and has been widely used both domestically and internationally in recent years. Structural heart surgery includes valvuloplasty, transcatheter aortic valve replacement (TAVR), transcatheter aortic valve implantation (TAVI), and transcatheter mitral valve replacement (TAMR).

[0003] During structural heart surgery, downstream and upstream pressure curves can be used to determine the condition of the heart valves, the blood flow status through the heart valves, and in some cases, to determine how and when to treat the patient.

[0004] Currently, downstream and upstream pressure curves are typically measured using a pressure guidewire and other pressure sensing devices. These curves can be provided by a guide catheter pressure sensor, a pressure guidewire, or another pressure-sensing device. For example, a pressure sensing device can sense the pressure on the first side of a heart valve, such as in the aorta or atrium, while a pressure guidewire can sense the pressure on the second side of a heart valve, such as in the left or right ventricle.

[0005] The above measurement method requires the pressure guidewire to be used in conjunction with other pressure sensing devices to measure the downstream and upstream pressure curves of the valve, and also necessitates calibration and balancing of the pressure guidewire with other pressure sensing devices, making the operation complex. There is an urgent need for an improved pressure guidewire. Utility Model Content

[0006] Therefore, the object of this disclosure is to provide a pressure guidewire that solves the above-mentioned problems.

[0007] The above objective is achieved by using a pressure guidewire as described below.

[0008] A pressure guidewire includes: a guidewire body, the guidewire body including a tube wall and an inner cavity defined by the tube wall; a first sensor assembly and a second sensor assembly are sequentially disposed along the proximal end to the distal end of the guidewire body, the first sensor assembly and the second sensor assembly being disposed in the inner cavity; each of the first sensor assembly and the second sensor assembly includes a pressure sensor and a wire connected to the pressure sensor and extending from the pressure sensor toward the proximal end of the guidewire body; a pressure sensing hole is provided on the tube wall at the location of the pressure sensor.

[0009] In one embodiment, the pressure sensor is an optical pressure sensor, and the wire is an optical fiber.

[0010] In one embodiment, the pressure guidewire further includes an optical fiber connector disposed in the inner cavity of the guidewire body, wherein the two optical fibers included in the first sensor assembly and the second sensor assembly are connected to an external optical cable through the same optical fiber connector.

[0011] In one embodiment, the distance between the first pressure sensor included in the first sensor assembly and the second pressure sensor included in the second sensor assembly is 5cm-15cm.

[0012] In one embodiment, the pressure guidewire further includes a first injection hole disposed on the proximal side of the first pressure sensor included in the first sensor assembly, near the guidewire body.

[0013] In one embodiment, the pressure guide wire further includes a first vent hole disposed between the injection hole and the first pressure sensor.

[0014] In one embodiment, the distance between the vent hole and the injection hole is 0.3mm-5mm.

[0015] In one embodiment, the pressure guide wire further includes a second injection hole disposed between the first pressure sensor of the first sensor assembly and the second pressure sensor of the second sensor assembly.

[0016] In one embodiment, the pressure guide wire further includes a second vent hole disposed between the second injection hole and the second pressure sensor.

[0017] In one embodiment, the pressure sensor is a Fabry-Perot pressure sensor.

[0018] In one embodiment, the second pressure sensor is disposed at the distal end of the guidewire body.

[0019] In one embodiment, the pressure sensor included in at least one of the first sensor assembly and the second sensor assembly is disposed in a retainer, the retainer being fixedly connected to other sections of the guidewire body. Attached Figure Description

[0020] To more clearly illustrate the technical solutions of the embodiments of this disclosure, the accompanying drawings of the embodiments of this disclosure will be briefly described below. The drawings are merely illustrative of some embodiments of this disclosure and are not intended to limit the scope of all embodiments of this disclosure. In the drawings:

[0021] Figure 1 A schematic diagram of the structure of a pressure guidewire according to a first embodiment of the present disclosure is shown;

[0022] Figure 2 , 3 A cross-sectional view of a pressure guidewire according to a first embodiment of the present disclosure is shown;

[0023] Figure 4 A schematic diagram of the structure of a pressure guidewire according to a second embodiment of the present disclosure is shown;

[0024] Figure 5 A cross-sectional view of a pressure guidewire according to a second embodiment of the present disclosure is shown;

[0025] Figure 6 A schematic diagram of the structure of a pressure guidewire according to a third embodiment of the present disclosure is shown;

[0026] Figure 7 A cross-sectional view of a pressure guidewire according to a third embodiment of the present disclosure is shown.

[0027] 1-Guidewire body 11-Proximal end of guidewire body 12-Distal end of guidewire body 13-Tube wall 14-Inner cavity 2-Second pressure sensor 21-Second pressure sensing hole 22-Second wire 23-Second glue injection hole 24-Second vent hole 25-Second retainer 3-First pressure sensor 31-First pressure sensing hole 32-First wire 33-First glue injection hole 34-First vent hole 35-First retainer 4-Head end core wire Detailed Implementation

[0028] To make the objectives, technical solutions, and advantages of this disclosure clearer, the technical solutions of the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. The same reference numerals in the drawings represent the same components. It should be noted that the described embodiments are only some, not all, of the embodiments of this disclosure. All other embodiments obtained by those skilled in the art based on the described embodiments of this disclosure without creative effort are within the scope of protection of this disclosure.

[0029] Unless otherwise defined, the technical or scientific terms used herein shall have the ordinary meaning as understood by one of ordinary skill in the art to which this disclosure pertains. The terms “first,” “second,” and similar terms used in this patent application specification and claims do not indicate any order, quantity, or importance, but are merely used to distinguish different components. Similarly, the terms “an” or “a” and similar terms do not necessarily indicate a quantity limitation. The terms “comprising,” “including,” or “having,” and similar terms mean that the element or object preceding the word encompasses the element or object listed following the word and its equivalents, without excluding other elements or objects. The terms “connected” or “connected,” and similar terms are not limited to the physical or mechanical connection or connection shown in the drawings, but may include equivalent connections or connections, whether direct or indirect. The terms “upper,” “lower,” “left,” and “right,” etc., are used only to indicate relative positional relationships, which may change accordingly when the absolute position of the described object changes.

[0030] The following is for reference. Figures 1 to 7 A detailed description of embodiments of the pressure guidewire according to this disclosure is provided.

[0031] A pressure guidewire includes: a guidewire body 1, the guidewire body including a tube wall 13 and an inner cavity 14 defined by the tube wall 13; a first sensor assembly and a second sensor assembly are sequentially disposed along the proximal end 11 to the distal end 12 of the guidewire body, the first sensor assembly and the second sensor assembly being located in the inner cavity 14; the first sensor assembly includes a first pressure sensor 3 and a first wire 32 connected to the first pressure sensor 3 and extending from the first pressure sensor 3 toward the proximal end 11 of the guidewire body; the second sensor assembly includes a second pressure sensor 2 and a second wire 22 connected to the second pressure sensor 2 and extending from the second pressure sensor 2 toward the proximal end 11 of the guidewire body.

[0032] The proximal end of the guidewire body is the part that is close to the outside of the body during the diagnosis and treatment process. The operator controls the pressure guidewire through this proximal part to make it travel along the blood vessels or non-vascular cavities of the human body. The distal end of the guidewire body is the part that enters the blood vessels or non-vascular cavities of the human body.

[0033] The guide wire body 1 has a first pressure sensing hole 31 and a second pressure sensing hole 21 respectively provided on the tube wall 13. The first pressure sensing hole 31 is located at the position of the first pressure sensor 3 of the first sensor assembly, and the second pressure sensing hole 21 is located at the position of the second pressure sensor 2 of the second sensor assembly.

[0034] The pressure sensor can be an optical sensor or an electrical sensor, a membrane-based sensor, a MEMS sensor, or other device that can generate a signal in response to pressure levels or fluctuations. The wire can be an optical fiber or a wire. Correspondingly, when the pressure sensor is an optical sensor, the wire is an optical fiber, and when the sensor is an electrical sensor, the wire is a wire. In one embodiment, the first pressure sensor 3 and the second pressure sensor 2 employ optical sensors, which can resist electromagnetic interference and improve measurement accuracy.

[0035] In one embodiment, a pressure sensor is disposed in a retainer, the retainer having a pressure sensing hole, and the retainer is connected to the guide wire body 1, the connection method including but not limited to plug-in connection. Figure 2 The fixtures shown are the first pressure sensor holder 35 and the second pressure sensor holder 25.

[0036] The guidewire body 1 can be made of stainless steel with a PTFE coating. The length of the guidewire body is unlimited, for example, not less than 260cm. The outer diameter of the guidewire body is not greater than 1mm, the inner diameter is not greater than 0.37mm, and the wall thickness 13 of the guidewire body can be 0.2mm-0.7mm. The shape and size of the first pressure sensing hole 31 and the second pressure sensing hole 21 are unlimited; for example, a length of 1mm-5mm and a width of 0.5mm-0.8mm can be selected. The first pressure sensing hole 31 can be located at any position around the wall of the guidewire body at the location of the first pressure sensor 3.

[0037] The pressure guidewire disclosed herein can be positioned so that the first sensor assembly and the second sensor assembly are located upstream and downstream of the aortic valve or mitral valve, respectively, to simultaneously monitor the upstream and downstream pressure curves of the valve. This allows for direct measurement of the transvalvular blood pressure gradient without the need to operate multiple pressure sensing devices, making operation convenient. It also minimizes disruption to the normal functioning of the valve.

[0038] In one embodiment, the second pressure sensor is 5cm-15cm away from the first pressure sensor, so that during cardiac surgery, the first and second pressure sensors can be placed downstream and upstream of the aortic valve or mitral valve, respectively, to measure the pressure gradient. The second pressure sensor can be located near the distal end of the guidewire body. A tip core wire and a contrast spring connected to the guidewire body 1 can also be located at the distal end of the guidewire body 1. Figure 2 The image shows the head end core wire 4 of the insert retainer.

[0039] like Figures 4-5As shown in the structural schematic diagram of the pressure guide wire according to the second embodiment of this disclosure, the guide wire body may also be provided with a first glue injection hole 33 to inject adhesive into the inner cavity 14, thereby attaching the first wire 32 and the second wire 22 to the tube wall 13, thereby fixing the first pressure sensor and the second pressure sensor. The position of the first glue injection hole 33 can be set at any position between the proximal end 11 of the guide wire body and the first pressure sensor 3. The distance between the first glue injection hole 33 and the first pressure sensor 3 is not limited. Preferably, the distance between the first glue injection hole 33 and the first pressure sensor 3 is less than 2 cm.

[0040] A first vent hole 34 can also be provided between the first glue injection hole 33 and the first pressure sensor 3. The distance between the first vent hole 34 and the first glue injection hole 33 is approximately 0.3mm-5mm. When the pressure guide wire is placed in the pressure measuring medium, the gas between the pressure sensor and the glue injection hole will affect the pressure measuring accuracy of the pressure sensor. The gas in the pressure guide wire can be discharged through the vent hole, thereby ensuring that the pressure sensor is completely surrounded in the pressure measuring medium, improving the measurement accuracy and reducing the measurement error.

[0041] like Figures 6-7 As shown in the structural schematic diagram of the pressure guide wire according to the third embodiment of the present disclosure, a second injection hole 23 may be provided at any position between the first pressure sensor 3 and the second pressure sensor 2, and the second pressure sensor may be fixed by injecting glue into the inner cavity through the second injection hole 23.

[0042] In one embodiment, the pressure guidewire further includes an optical fiber connector disposed within the inner cavity of the guidewire body. The two optical fibers included in the first sensor assembly and the second sensor assembly are connected to an external optical cable via the same optical fiber connector, thereby ensuring fiber alignment. The optical fiber connector can be a coupler, circulator, etc. This facilitates the connection operation of the guidewire and improves coupling efficiency and optical power.

[0043] Furthermore, the technical features disclosed above are not limited to the combinations of the disclosed features with other features. Those skilled in the art can also make other combinations of the technical features according to the purpose of the disclosure in order to achieve the purpose of this disclosure.

Claims

1. A pressure guidewire, characterized in that, include: A guidewire body, the guidewire body including a tube wall and an inner cavity defined by the tube wall; A first sensor assembly and a second sensor assembly are sequentially arranged from the proximal end to the distal end of the guidewire body, and the first sensor assembly and the second sensor assembly are disposed in the inner cavity; Both the first sensor assembly and the second sensor assembly include a pressure sensor and a wire connected to the pressure sensor and extending from the pressure sensor toward the proximal end of the guidewire body; A pressure sensing hole is provided on the pipe wall at the location of the pressure sensor.

2. The pressure guidewire according to claim 1, characterized in that, The pressure sensor is an optical pressure sensor, and the wire is an optical fiber.

3. The pressure guidewire according to claim 2, characterized in that, Also includes: An optical fiber connector is disposed in the inner cavity of the guidewire body, and the two optical fibers contained in the first sensor assembly and the second sensor assembly are connected to an external optical cable through the same optical fiber connector.

4. The pressure guidewire according to claim 1, characterized in that, The distance between the first pressure sensor included in the first sensor assembly and the second pressure sensor included in the second sensor assembly is 5cm-15cm.

5. The pressure guidewire according to claim 1, characterized in that, Also includes: The first injection hole is located on the proximal side of the first pressure sensor included in the first sensor assembly, near the guidewire body.

6. The pressure guidewire according to claim 5, characterized in that, Also includes: The first vent hole is located between the first injection hole and the first pressure sensor.

7. The pressure guidewire according to claim 6, characterized in that, The distance between the first vent hole and the first injection hole is 0.3mm-5mm.

8. The pressure guidewire according to claim 6, characterized in that, Also includes: The second injection hole is located between the first pressure sensor of the first sensor assembly and the second pressure sensor of the second sensor assembly.

9. The pressure guidewire according to claim 8, characterized in that, Also includes: The second vent is located between the second injection hole and the second pressure sensor.

10. The pressure guidewire according to claim 1, characterized in that, The pressure sensor is a Fabry-Perot pressure sensor.

11. The pressure guidewire according to claim 1, characterized in that, The second sensor assembly includes a second pressure sensor disposed at the distal end of the guidewire body.

12. The pressure guidewire according to claim 1, characterized in that, The pressure sensor included in at least one of the first sensor assembly and the second sensor assembly is disposed in the retainer, which is fixedly connected to other sections of the guide wire body.

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