A processing method for an intracranial pressure sensor probe and an intracranial pressure sensor probe resistant to intracranial tissue interference manufactured by using this method

Abstract

The present application discloses a processing method for an intracranial pressure sensor probe and an intracranial pressure sensor probe resistant to intracranial tissue interference manufactured by using this method. The method includes: axially along the probe catheter, arranging a pressure sensor at a position close to the catheter end; connecting the sensor membrane to an intracranial pressure monitor through electrode wires; fixing the two end edges of the sensor substrate along the radial direction of the probe catheter to the inner wall of the probe catheter by ultrasonic welding; and arranging a plurality of through holes for drainage on the side wall of the probe catheter. The present application solves the technical problems of sensitivity drift and zero drift of the sensor caused by intracranial tissue covering and infection, can ensure the stability of intracranial pressure test data, and has a simple processing method, high production efficiency, and greatly reduces the production cost.

Description

Technical Field

[0001] The present application relates to a method for processing a sensor probe and a sensor probe, belonging to the technical field of medical devices, and particularly to a method for processing an intracranial pressure sensor probe and an intracranial pressure sensor probe that resists interference from intracranial tissues and is manufactured by using this method. Background Art

[0002] Among the publicly known intracranial pressure monitoring technologies, piezoresistive sensors can measure static values and better meet current clinical needs compared to piezocapacitive sensors. However, current intracranial pressure probes based on piezoresistive sensors still have some defects: the sensor is exposed outside the probe and directly contacts intracranial tissues, which is easily affected by intracranial tissue covering and infection during use, resulting in sensitivity drift and zero drift of the sensor, and it is difficult to accurately present data through hardware and software compensation.

[0003] Most products on the market currently adopt two main technologies: integrating a gauge pressure sensing chip in a protective sleeve to form a piezoresistive sensor, or fixing an optical fiber in a pipeline to form an optical fiber sensor. The structure of the piezoresistive sensor is complex, the manufacturing process is difficult, and it has an obvious impact on performance. The optical fiber sensor has certain limitations in product applications due to being easily affected by bending. In addition, the existing technology also has the problem of too high production costs if good stability of pressure test data is to be achieved. Summary of the Invention

[0004] According to one aspect of the present application, a method for processing an intracranial pressure sensor probe is provided. This method uses ultrasonic welding to fuse the inner wall of the catheter and the edge of the sensor substrate together, greatly reducing the difficulty of the production process and being able to avoid the technical problems of obvious performance impact and application limitations of piezoresistive sensors or optical fiber sensors.

[0005] The method for processing the intracranial pressure sensor probe includes the following steps:

[0006] Arrange a pressure sensor axially along the probe catheter at a position close to the catheter end. The pressure sensor includes a sensor substrate and a sensor film having the same size as the sensor substrate; the sensor film is a thin film sensing material covering the sensor substrate.

[0007] Connect the thin film sensing material to an intracranial pressure monitor through electrode wires for electrical signal processing.

[0008] Fix the two ends of the sensor substrate along the radial direction of the probe catheter to the inner wall of the probe catheter by ultrasonic welding.

[0009] Set a plurality of through holes for drainage on the side wall of the probe catheter.

[0010] The method further includes: fixing the position where the outer part of the polymer resin protective layer of the electrode wire contacts the inner wall of the probe catheter by ultrasonic welding.

[0011] Preferably, far-field ultrasonic waves are used for the ultrasonic welding, greatly reducing the production difficulty and cost.

[0012] Preferably, the fixing of the two end edges of the sensor substrate along the radial direction of the probe catheter to the inner wall of the probe catheter by ultrasonic welding includes the following steps:

[0013] (1) Using a vacuum drying oven to attach and fix the thin-film sensing material connected to the electrode wire and the sensor substrate by preheating and forming.

[0014] (2) Moving the sensor substrate to a position near the end in the inner cavity of the probe catheter, adjusting the positions of the sensor substrate and the electrode wire to avoid the through holes provided on the side wall of the probe catheter, and making the two end edges of the sensor substrate along the radial direction of the probe catheter completely contact the inner wall of the probe catheter.

[0015] (3) Placing one side of the end of the probe catheter in the liquid of a far-field ultrasonic welding device for ultrasonic welding, so that the two end edges of the sensor substrate, the contact surfaces of the electrode wire and the inner wall of the probe catheter are respectively welded and fixed to the inner wall of the probe catheter. After drying, an intracranial pressure sensor probe resistant to intracranial tissue interference can be obtained.

[0016] Preferably, the sensor substrate is arranged at a position 0.1 - 2 mm away from the end of the catheter. In clinical use, cerebrospinal fluid flows into the inner wall of the catheter through the through hole of the catheter, first fills the front catheter head of the catheter, and then flows outside the catheter. Placing the sensor here can ensure that the detected pressure is equivalent to the intracranial cerebrospinal fluid pressure.

[0017] Preferably, the thin-film sensing material is arranged on one or both sensing surfaces of the sensor substrate.

[0018] Preferably, when the thin-film sensing material is arranged on both sensing surfaces of the sensor substrate, it is denoted as the upper carbonized nanofiber membrane and the lower carbonized nanofiber membrane. One end of the electrode wire is connected to the upper carbonized nanofiber membrane and / or the lower carbonized nanofiber membrane, and the other end is connected to an intracranial pressure monitor.

[0019] Preferably, the number of the electrode wires is 2 - 4, that is, at least including positive and negative wiring, and ground wires and functional wires can be selectively added.

[0020] Preferably, the ultrasonic frequency during the ultrasonic welding and fixing is set to 5 KHz - 10 KHz.

[0021] Preferably, the power during ultrasonic welding and fixation is 50 - 90 kW.

[0022] Preferably, the conduction liquid for ultrasonic waves during ultrasonic welding and fixation is selected from purified water and physiological saline.

[0023] Preferably, the distance between the ultrasonic welding head and the welding wire during ultrasonic welding and fixation is 1 - 2 cm.

[0024] The above four preferred technical solutions have all been tested and verified, and the adhesion force between the sensor and the catheter processed within this condition range can meet the performance requirements.

[0025] Preferably, the edge of the sensor substrate has a tip convex structure.

[0026] Preferably, the material of the inner wall of the probe catheter is selected from one or more mixtures of PA12, PP, silica gel, TPU, and Pebax.

[0027] Preferably, the material of the sensor substrate is selected from one or more mixtures of ABS, PE, and PC.

[0028] Preferably, when the material of the inner wall of the probe catheter is P12, TPU, or Pebax, the material of the sensor substrate is ABS.

[0029] Preferably, the temperature condition of the preheating and forming method is 80°C - 100°C.

[0030] Preferably, the pressure condition of the preheating and forming method is 0.2 mpa - 0.5 mpa.

[0031] According to another aspect of the present application, there is provided an intracranial pressure sensor probe for resisting intracranial tissue interference made by the above processing method.

[0032] Preferably, the number of through holes of the intracranial pressure sensor probe for resisting intracranial tissue interference is set to 1 - 20.

[0033] Preferably, the diameter of the probe catheter of the intracranial pressure sensor probe for resisting intracranial tissue interference is 1 - 5 mm.

[0034] The above two preferred technical solutions are both for more convenient drainage of cerebrospinal fluid.

[0035] Preferably, the size of the sensor substrate of the intracranial pressure sensor probe for resisting intracranial tissue interference is: length 1 - 5 mm, width 0.7 - 2.7 mm, thickness 0.1 - 0.5 mm, which can match the size of the inner cavity of the intracranial drainage catheter.

[0036] Preferably, the end of the intracranial pressure sensor probe that resists interference from intracranial tissues is hemispherical in shape.

[0037] Preferably, the end material of the intracranial pressure sensor probe that resists interference from intracranial tissues is made of epoxy resin.

[0038] The beneficial effects that this application can produce include:

[0039] 1) The processing method of the intracranial pressure sensor probe provided by this application adopts the method of far-field ultrasonic welding, which greatly reduces the production difficulty and cost.

[0040] 2) The processing method of the intracranial pressure sensor probe provided by this application axially arranges the sensor substrate covered with the sensor film in the inner cavity of the probe catheter, and communicates with the cerebrospinal fluid through the catheter through-hole to keep the pressure consistent; the sensor will not be covered by intracranial tissues, and can overcome the defects that the optical sensor is not easy to bend and the piezoresistive sensor has a complex design and great implementation difficulty.

[0041] 3) This application can avoid the covering of the sensor film surface by soft tissues. Compared with the direct exposure method of the unilateral window sensor, it solves the problems of sensitivity drift and zero drift, and the intracranial pressure monitoring data is stable. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Figure 1 It is a schematic perspective view of the processing method and structure of the intracranial pressure sensor probe in an embodiment of this application;

[0043] Figure 2 It is a schematic diagram of the effect of the intracranial pressure sensor probe in an embodiment of this application. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0044] The following describes this application in detail with reference to the embodiments, but this application is not limited to these embodiments.

[0045] As Figure 1 shown, this application discloses a processing method of an intracranial pressure sensor probe, including the following steps:

[0046] Arrange the pressure sensor axially along the probe catheter at a position close to the end of the catheter. The pressure sensor includes a sensor substrate and a sensor film having the same size as the sensor substrate; the sensor film is a thin film sensing material covering the sensor substrate;

[0047] Connect the thin film sensing material to the intracranial pressure monitor through the electrode wire for electrical signal processing;

[0048] Fix the two ends of the sensor substrate along the radial direction of the probe catheter to the inner wall of the probe catheter by ultrasonic welding;

[0049] A plurality of through holes for drainage are provided on the side wall of the probe catheter.

[0050] The method further includes: fixing the position where the outer part of the polymer resin protective layer of the electrode wire contacts the inner wall of the probe catheter by ultrasonic welding.

[0051] In one embodiment, the ultrasonic welding uses far - field ultrasonic waves, which greatly reduces the production difficulty and cost.

[0052] In one embodiment, the step of fixing the two end edges of the sensor substrate along the radial direction of the probe catheter to the inner wall of the probe catheter by ultrasonic welding includes the following steps:

[0053] (1) Using a vacuum drying oven to attach and fix the thin - film sensing material connected to the electrode wire and the sensor substrate by pre - heating and forming;

[0054] (2) Moving the sensor substrate to a position near the end in the inner cavity of the probe catheter, adjusting the positions of the sensor substrate and the electrode wire to avoid the through holes provided on the side wall of the probe catheter, so that the two end edges of the sensor substrate along the radial direction of the probe catheter are in complete contact with the inner wall of the probe catheter;

[0055] (3) Placing one side of the end of the probe catheter in the liquid of a far - field ultrasonic welding device for ultrasonic welding, so that the two end edges of the sensor substrate, the contact surfaces of the electrode wire and the inner wall of the probe catheter are respectively welded and fixed to the inner wall of the probe catheter. After drying, an intracranial pressure sensor probe resistant to intracranial tissue interference can be obtained.

[0056] In one embodiment, the sensor substrate is arranged at a position 0.1 - 2 mm away from the end of the catheter.

[0057] In one embodiment, the thin - film sensing material is arranged on one or both sensing surfaces of the sensor substrate.

[0058] In one embodiment, when the thin - film sensing material is arranged on both sensing surfaces of the sensor substrate, it is denoted as the upper carbonized nanofiber film and the lower carbonized nanofiber film. One end of the electrode wire is connected to the upper carbonized nanofiber film and / or the lower carbonized nanofiber film, and the other end is connected to an intracranial pressure monitor.

[0059] In one embodiment, the number of the electrode wires is 2 - 4, that is, at least including positive and negative wiring, and ground wires and function wires can be selectively added.

[0060] In one embodiment, the ultrasonic frequency during the ultrasonic welding and fixing is set to 5 KHz - 10 KHz.

[0061] In one embodiment, the power during ultrasonic welding and fixing is 50 - 90 kW.

[0062] In one embodiment, the conduction liquid for ultrasonic waves during ultrasonic welding and fixing is selected from one of purified water and physiological saline liquid.

[0063] In one embodiment, the distance between the ultrasonic welding head and the welding wire during ultrasonic welding and fixing is 1 - 2 cm.

[0064] In one embodiment, the edge of the sensor substrate has a tip convex structure.

[0065] In one embodiment, the material of the inner wall of the probe catheter is selected from one or a mixture of PA12, PP, silica gel, TPU, and Pebax.

[0066] In one embodiment, the material of the sensor substrate is selected from one or a mixture of ABS, PE, and PC.

[0067] In one embodiment, when the material of the inner wall of the probe catheter is selected from PA12, TPU, and Pebax, the material of the sensor substrate is selected from ABS.

[0068] In one embodiment, the temperature condition of the preheating and forming method is 80°C - 100°C.

[0069] In one embodiment, the pressure condition of the preheating and forming method is 0.2 mpa - 0.5 mpa.

[0070] According to another aspect of the present application, there is provided an intracranial pressure sensor probe for resisting intracranial tissue interference made by the above processing method, as Figure 2 shown.

[0071] In one embodiment, the number of through holes of the intracranial pressure sensor probe for resisting intracranial tissue interference is set to 1 - 20.

[0072] In one embodiment, the diameter of the probe catheter of the intracranial pressure sensor probe for resisting intracranial tissue interference is 1 - 5 mm.

[0073] In one embodiment, the size of the sensor substrate of the intracranial pressure sensor probe for resisting intracranial tissue interference is: length is 1 - 5 mm, width is 0.7 - 2.7 mm, and thickness is 0.1 - 0.5 mm.

[0074] In one embodiment, the end shape of the intracranial pressure sensor probe for resisting intracranial tissue interference is hemispherical.

[0075] In one embodiment, the end material of the intracranial pressure sensor probe resistant to intracranial tissue interference is selected as epoxy resin.

[0076] The above are only several embodiments of the present application and do not impose any form of limitation on the present application. Although the present application is disclosed above with preferred embodiments, it is not intended to limit the present application. Any person skilled in the art, without departing from the technical solution of the present application, makes some changes or modifications using the technical content disclosed above, which are all equivalent to equivalent implementation cases and fall within the scope of the technical solution.

Claims

1. A method for processing an intracranial pressure sensor probe, characterized in that: The method comprises the following steps: The pressure sensor is arranged at a position close to the catheter end along the axial direction of the probe catheter, wherein the pressure sensor comprises a sensor substrate and a sensor membrane having the same size as the sensor substrate; the sensor membrane is a thin film sensing material covering the sensor substrate; Connecting the thin film sensing material to an intracranial pressure monitor via an electrode wire for electrical signal processing; Fixing the two end edges of the sensor substrate along the radial direction of the probe tube to the inner wall of the probe tube by ultrasonic welding; A plurality of through holes for drainage are arranged on the side wall of the probe catheter; The step of fixing the two radial ends of the sensor substrate to the inner wall of the probe tube by ultrasonic welding comprises the following steps: (1) Using a vacuum drying oven, the thin film sensing material connected with the electrode wire is attached and fixed to the sensor substrate by preheating and molding; (2) moving the sensor substrate to a position close to the end of the inner cavity of the probe catheter, adjusting the positions of the sensor substrate and the electrode wire so that they avoid the through holes provided on the side wall of the probe catheter, and making the two end edges of the sensor substrate along the radial direction of the probe catheter completely contact the inner wall of the probe catheter; (3) Placing one side of the end of the probe catheter in the liquid of a far-field ultrasonic welding device and performing ultrasonic welding so that the two end edges of the sensor substrate and the contact surface between the electrode wire and the inner wall of the probe catheter are respectively welded and fixed to the inner wall of the probe catheter. After drying, an intracranial pressure sensor probe that is resistant to interference from intracranial tissues can be obtained.

2. The processing method according to claim 1, characterized in that: The method further comprises: fixing the position where the outside of the polymer resin protective layer of the electrode wire contacts the inner wall of the probe catheter by ultrasonic welding.

3. The processing method according to claim 2, characterized in that: The ultrasonic welding adopts far-field ultrasonic waves.

4. The processing method according to claim 1, characterized in that: The sensor substrate is arranged at a distance of 0.1 to 2 mm from the catheter tip.

5. The processing method according to claim 1, characterized in that: The thin film sensing material is arranged on one or both sides of the sensing surface of the sensor substrate.

6. The processing method according to claim 1, characterized in that: When the thin film sensing material is arranged on the double-sided sensing surfaces of the sensor substrate, it is recorded as an upper carbonized nanofiber membrane and a lower carbonized nanofiber membrane, one end of the electrode wire is connected to the upper carbonized nanofiber membrane and / or the lower carbonized nanofiber membrane, and the other end is connected to the intracranial pressure monitor.

7. The processing method according to claim 1, characterized in that: The number of the electrode wires is 2 to 4.

8. The processing method according to claim 1, characterized in that: The ultrasonic frequency during the ultrasonic welding fixation is set to 5KHz~10KHz.

9. The processing method according to claim 1, characterized in that: The power of the ultrasonic welding fixation is 50-90 kW.

10. The processing method according to claim 1, characterized in that: During the ultrasonic welding fixation, the ultrasonic wave conducting liquid is selected from one of purified water and physiological saline solution.

11. The processing method according to claim 1, characterized in that: During the ultrasonic welding fixation, the distance between the ultrasonic welding head and the welding line is 1-2 cm.

12. The processing method according to claim 1, characterized in that: The edge of the sensor substrate has a pointed protrusion structure.

13. The processing method according to claim 1, characterized in that: The material of the inner wall of the probe catheter is selected from one or more mixtures of PA12, PP, silicone, TPU, and Pebax.

14. The processing method according to claim 1, characterized in that: The material of the sensor substrate is selected from ABS, PE, PC or a mixture thereof.

15. The processing method according to claim 13, characterized in that: When the material of the inner wall of the probe tube is PA12, TPU, or Pebax, the material of the sensor substrate is ABS.

16. The processing method according to claim 1, characterized in that: The temperature condition of the preheating forming method is 80°C-100°C.

17. The processing method according to claim 1, characterized in that: The pressure condition of the preheating forming method is 0.2 MPa~0.5 MPa.

18. An intracranial pressure sensor probe resistant to intracranial tissue interference manufactured by the processing method according to any one of claims 1 to 17.

19. The intracranial pressure sensor probe resistant to intracranial tissue interference according to claim 18, characterized in that: The number of through holes of the intracranial pressure sensor probe that resists intracranial tissue interference is set to 1 to 20.

20. The intracranial pressure sensor probe resistant to intracranial tissue interference according to claim 18, characterized in that: The diameter of the probe catheter of the intracranial pressure sensor probe that resists intracranial tissue interference is 1-5 mm.

21. The intracranial pressure sensor probe resistant to intracranial tissue interference according to claim 18, characterized in that: The dimensions of the sensor substrate of the intracranial pressure sensor probe that resists intracranial tissue interference are: length 1-5 mm, width 0.7-2.7 mm, and thickness 0.1-0.5 mm.

22. The intracranial pressure sensor probe resistant to intracranial tissue interference according to claim 18, characterized in that: The tip of the intracranial pressure sensor probe that resists intracranial tissue interference is hemispherical.

23. The intracranial pressure sensor probe resistant to intracranial tissue interference according to claim 18, characterized in that: The tip material of the intracranial pressure sensor probe that resists intracranial tissue interference is epoxy resin.

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