CN117322862B - Method for manufacturing intracranial pressure sensor probe and intracranial pressure sensor probe - Google Patents
Method for manufacturing intracranial pressure sensor probe and intracranial pressure sensor probe Download PDFInfo
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- CN117322862B CN117322862B CN202311617523.6A CN202311617523A CN117322862B CN 117322862 B CN117322862 B CN 117322862B CN 202311617523 A CN202311617523 A CN 202311617523A CN 117322862 B CN117322862 B CN 117322862B
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/03—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs
- A61B5/031—Intracranial pressure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/02—Details of sensors specially adapted for in-vivo measurements
- A61B2562/0247—Pressure sensors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/02—Details of sensors specially adapted for in-vivo measurements
- A61B2562/0252—Load cells
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/12—Manufacturing methods specially adapted for producing sensors for in-vivo measurements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biomedical Technology (AREA)
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Abstract
The invention discloses a method for manufacturing an intracranial pressure sensor probe and the intracranial pressure sensor probe, wherein the method comprises the steps of placing a shell in coating equipment for coating; forming a conformal corrosion protection layer on the exposed metal surface in the pressure sensor assembly at one time; mounting the pressure sensor assembly into the housing and aligning the detection window; and filling the silica gel support layer into the detection window and attaching the silica gel support layer to the coating layer. The shell is subjected to coating treatment, so that a coating layer is formed on the outer surface of the shell at the detection window, and when the intracranial pressure sensor probe is packaged, the silica gel supporting layer is filled into the detection window and is tightly attached to the coating layer, and the coating layer serves as an intermediate layer structure between the shell and the silica gel supporting layer, so that the attaching effect between the shell and the silica gel supporting layer is improved, and the problems of low surface activity and poor adhesiveness of the shell are solved. In addition, the conformal anti-corrosion layer is formed at one time, so that the bare metal of the pressure sensor assembly can be effectively prevented from being corroded.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to a manufacturing method of an intracranial pressure sensor probe and the intracranial pressure sensor probe.
Background
The intracranial pressure monitoring provides basis for accurately judging intracranial pressure (ICP) change conditions caused by occupancy diseases such as intracranial tumor, intracranial trauma, cerebral hemorrhage, cerebral edema and the like in clinic, and can meet the requirements of diagnosis, treatment and prognosis judgment. Generally, an intracranial pressure sensor probe adopts a metal shell, a pressure sensor chip is accommodated in the shell, a silica gel supporting layer is formed on a detection window of the shell, and the intracranial pressure is conducted onto the pressure sensor chip through the silica gel supporting layer. In addition, the adhesion promoter is usually required to be locally attached at the detection window of the shell by spraying, brushing and the like, so as to improve the fixing effect between the shell and the silica gel supporting layer. Because the shell is of a miniaturized structure, the process window is limited, and meanwhile, the curing of the tackifier is timeliness and the operation time is limited, the adhesion process of the tackifier is very difficult to operate, and gaps are very easy to appear at the contact surface between the detection window of the shell and the silica gel supporting layer due to nonuniform adhesion of the tackifier; in addition, the tackifier is also easily coated on the pressure-sensitive film of the pressure sensor chip by mistake, and the signal transmission and measurement accuracy of the internal circuit are affected.
Disclosure of Invention
The present invention aims to solve at least one of the technical problems existing in the prior art. Therefore, the invention provides a method for manufacturing an intracranial pressure sensor probe, which solves the problem that firm adhesion between a shell and a silica gel supporting layer is difficult to realize by using the existing manufacturing method.
The invention also provides an intracranial pressure sensor probe.
According to a first aspect of the invention, a method for manufacturing an intracranial pressure sensor probe comprises the following steps:
placing the shell in a coating device for coating so as to form a coating layer at least on the outer surface around a detection window of the shell;
forming a conformal corrosion protection layer on the exposed metal surface in the pressure sensor assembly at one time;
mounting the pressure sensor assembly into the housing and aligning the detection window;
and filling the silica gel protective layer into the detection window to be attached to the coating layer, wherein the silica gel protective layer is used for conducting pressure to the pressure sensor component.
The method for manufacturing the intracranial pressure sensor probe has at least the following beneficial effects:
the shell is subjected to coating treatment, so that a coating layer is formed on the outer surface of the shell at the detection window, the coating layer is made of hydrophilic materials, the surface of the coating layer contains more free hydroxyl groups, and the coating layer is polymerized with silicon hydroxyl groups contained in the silica gel supporting layer, so that better adhesion can be formed. Therefore, when the intracranial pressure sensor probe is packaged, the silica gel supporting layer is filled in the detection window and is tightly attached to the coating layer, and the coating layer is used as an intermediate layer structure between the shell and the silica gel supporting layer, so that the attaching effect between the shell and the silica gel supporting layer is improved, and the problems of low surface activity and poor adhesiveness of the shell are solved. Therefore, the manufacturing method of the intracranial pressure sensor probe realizes firm adhesion between the shell and the silica gel supporting layer. In addition, the invention can realize uniform coating treatment, does not need to carry out operations such as spraying, brushing and the like of the tackifier locally like the prior art, does not cause any influence on the pressure sensor chip, and obviously reduces the process difficulty. In addition, the conformal anti-corrosion layer is formed at one time, so that the exposed metal parts or areas of the pressure sensor assembly can be effectively prevented from being corroded.
According to some embodiments of the invention, before the step of placing the housing in a plating apparatus for plating, the method for manufacturing an intracranial pressure sensor probe further comprises the steps of:
placing the shell on a clamp base and enabling the detection window to face upwards;
placing a clamp upper cover on the clamp base to fix the housing;
the clamp comprises a clamp base, a shell, a clamp cover and a clamp cover, wherein the clamp base is provided with a containing groove, the containing groove is used for containing the shell, a limiting groove and a hollowed-out window are formed in the clamp cover, the limiting groove is used for fixing the shell, and the hollowed-out window is aligned with the detection window.
According to some embodiments of the invention, before the step of placing the housing in a plating apparatus for plating, the method for manufacturing an intracranial pressure sensor probe further comprises the steps of:
immersing the shell into a cleaning working liquid for cleaning, and cleaning the residual cleaning working liquid after the cleaning is completed.
According to some embodiments of the invention, after the step of placing the housing in a plating apparatus for plating, the method for manufacturing an intracranial pressure sensor probe further comprises the steps of:
and carrying out plasma surface treatment on the shell.
According to some embodiments of the invention, the pressure sensor assembly includes a relative pressure sensor chip, a first wire, and a second wire; before the step of mounting the pressure sensor assembly into the housing and aligning the detection window, the intracranial pressure sensor probe fabrication method further comprises the steps of:
welding one end of the first wire to a bonding pad of the opposite pressure sensor chip to form a first welding spot, wherein the first wire is a bare wire, and the opposite pressure sensor chip forms a free end through the first wire;
and directly welding one end of the second wire with the other end of the first wire to form a second welding spot so as to obtain the pressure sensor assembly, wherein the second wire is an enameled wire, and one end of the second wire is a bare area.
According to some embodiments of the present invention, the conformal corrosion protection layer is formed once for the presence of a bare metal surface in the pair of pressure sensor assemblies, comprising the steps of:
immersing the pressure sensor component in electroplating liquid to perform anti-corrosion treatment on an easily-corroded area so as to realize conformal electroplated layers at one time, wherein the electroplated layers are entirely wrapped around the easily-corroded area, the pressure sensor component is used as a cathode, and the easily-corroded area comprises the first lead, the first welding point, the second welding point and the exposed area.
An intracranial pressure sensor probe according to an embodiment of the second aspect of the invention, the intracranial pressure sensor probe comprising:
the shell is internally provided with an accommodating space, and at least one detection window is formed in the shell;
the coating layer is at least formed on the outer surface of the shell around the detection window;
the pressure sensor component is arranged in the accommodating space and aligned with the detection window, and a conformal anti-corrosion layer is formed on the exposed metal surface of the pressure sensor component;
and the silica gel support layer is filled in the detection window, is attached to the coating layer and is used for conducting pressure to the pressure sensor assembly.
According to some embodiments of the invention, the opening of the detection window is provided with an inclined plane so as to form a necking structure which gradually reduces from outside to inside.
According to some embodiments of the invention, the housing is further provided with a wire connection port, and the pressure sensor assembly includes:
the relative pressure sensor chip is arranged in the accommodating space;
the first lead is provided with a chip connecting end and a lead connecting end, the chip connecting end is welded with the opposite pressure sensor chip and forms a first welding point, the first lead is arranged as a bare wire, the first lead is arranged in the accommodating space, and the opposite pressure sensor chip forms a free end through the first lead;
the second wire is arranged as an enameled wire, one end of the second wire is an exposed area, the exposed area is directly welded with the wire connecting end to form a second welding spot, one end of the second wire is arranged in the accommodating space, the other end of the second wire extends to the outside through the wire connecting port, and an air passage communicated with the wire connecting port is formed below the relative pressure sensor chip;
the anti-corrosion layer is arranged to realize conformal electroplated layers at one time through electroplating equipment, and is integrally wrapped on the first lead, the first welding spot, the second welding spot and the exposed area in a surrounding mode.
According to some embodiments of the invention, the coating layer includes at least one of a silicon oxide film layer, a silicon nitride film layer, and an aluminum oxide film layer.
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.
Drawings
The foregoing and/or additional aspects and advantages of the invention will become apparent and may be better understood from the following description of embodiments taken in conjunction with the accompanying drawings in which:
FIG. 1 is a flow chart of a method of fabricating an intracranial pressure sensor probe in accordance with one embodiment of the present invention;
FIG. 2 is a schematic illustration showing the effect of a coating process according to an embodiment of the present invention;
FIG. 3 is a schematic diagram of an intracranial pressure sensor probe according to an embodiment of the present invention;
FIG. 4 is a schematic illustration of the effect of placing a housing in a fixture according to one embodiment of the invention;
FIG. 5 is a flow chart of a method of fabricating an intracranial pressure sensor probe in accordance with a preferred embodiment of the present invention;
FIG. 6 is a schematic diagram of the structure of a relative pressure sensor chip according to one embodiment of the present invention;
FIG. 7 is a schematic view of an intracranial pressure sensor probe in accordance with another embodiment of the invention.
Reference numerals:
a housing 110; a relative pressure sensor chip 120; a first wire 130; a second wire 140; a first solder joint 150; a second solder joint 160; a coating layer 170; a silicone gel support 180;
a jig base 210; a clamp upper cover 220;
a pad 310; an internal circuit 320; a pressure sensitive film 330;
a temperature sensor 410; and a third wire 420.
Detailed Description
Embodiments of the present invention are described in detail below, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to like or similar elements or elements having like or similar functions throughout. The embodiments described below by referring to the drawings are illustrative only and are not to be construed as limiting the invention.
The following description of the embodiments of the present invention will be made with reference to the accompanying drawings, in which it is apparent that the embodiments described below are some, but not all embodiments of the invention.
Referring to fig. 1, a flowchart of a method for manufacturing an intracranial pressure sensor probe according to an embodiment of the invention includes the following steps:
step S110: placing the housing 110 in a plating apparatus to perform plating so as to form a plating layer 170 on at least an outer surface around a detection window of the housing 110;
step S120: forming a conformal corrosion protection layer on the exposed metal surface in the pressure sensor assembly at one time;
step S130: mounting the pressure sensor assembly into the housing 110 and aligning the detection window;
step S140: the silica gel supporting layer 180 is filled in the detection window and is attached to the coating layer 170, and the silica gel supporting layer 180 is used for conducting pressure to the pressure sensor assembly.
Referring to fig. 2, first, step S110 is performed, and the housing 110 is placed in a plating apparatus to perform plating, so that a plating layer 170 is formed on at least an outer surface around a detection window of the housing 110, as shown in the specific plating effect. It is understood that the plating method may be chemical vapor deposition, physical vapor deposition, atomic layer deposition, or the like. Then, step S120 is performed to form a conformal anti-corrosion layer on the exposed metal surface of the pressure sensor assembly at one time, so that the problem that the metal exposure degree deviation of the pressure sensor assemblies in different batches is larger can be solved.
Referring to fig. 3, step S130 is then performed to mount the pressure sensor assembly into the housing 110 and facing the detection window; finally, step S140 is executed, the silica gel supporting layer 180 is fully filled in the detection window and is attached to the coating layer 170, so that the attaching firmness between the silica gel supporting layer 180 and the housing 110 is high, the pressure sensor assembly is sealed in the housing 110, and finally the intracranial pressure probe is obtained. The silicone jacket 180 also serves to conduct pressure to the pressure sensor assembly, ensuring proper operation of the pressure sensor assembly within the housing 110.
In this embodiment, the coating layer 170 is formed on the outer surface of the housing 110 at the detection window by performing the coating treatment on the housing 110, the coating layer 170 is made of hydrophilic material, and the surface of the coating layer contains more free hydroxyl groups and is polymerized with the silicon hydroxyl groups contained in the silica gel supporting layer 180, so that better adhesion can be formed. Therefore, when the intracranial pressure sensor probe is packaged, the silica gel supporting layer 180 is filled in the detection window and is tightly attached to the coating layer 170, and the coating layer 170 is used as an intermediate layer structure between the shell 110 and the silica gel supporting layer 180, so that the attaching effect between the shell 110 and the silica gel supporting layer 180 is improved, and the problems of low surface activity and poor adhesiveness of the shell 110 are solved. Therefore, the method for manufacturing the intracranial pressure sensor probe realizes firm adhesion between the shell 110 and the silica gel supporting layer 180. In addition, the shell 110 is uniformly coated, operations such as spraying, brushing and the like of a tackifier part are not needed like the prior art, no influence is caused on the pressure sensor chip, and the process difficulty is obviously reduced. In addition, the conformal anti-corrosion layer is formed at one time, so that the exposed metal parts or areas of the pressure sensor assembly can be effectively prevented from being corroded.
As shown in fig. 4 and 5, before the step of placing the housing 110 in the plating apparatus for plating, the method for manufacturing the intracranial pressure sensor probe further includes the steps of:
step S210: placing the housing 110 on the jig base 210 with the detection window directed upward;
step S220: placing the jig upper cover 220 on the jig base 210 to fix the housing 110;
wherein, the fixture base 210 is provided with a containing groove, the containing groove is used for placing the shell 110, the fixture upper cover 220 is provided with a limit groove and a hollowed-out window, the limit groove is used for fixing the shell 110, and the hollowed-out window is aligned with the detection window.
Referring to fig. 4 and 5, it can be understood that, before the coating of the housing 110, that is, before the step S110 is performed, the steps S210 and S220 of the present embodiment may be performed, that is, the housing 110 is placed in a fixture to be fixed, so as to facilitate the subsequent coating process. Specifically, the jig includes a jig base 210 and a jig upper cover 220; the hollowed-out window facilitates the deposition of the coating 170 on the housing 110. In this embodiment, in addition to the plating layer 170 formed on the outer surface around the detection window of the housing 110, the plating layer 170 is also formed on the inner wall of the housing 110 corresponding directly under the detection window.
As shown in FIG. 5, before the step of placing the housing 110 in a plating apparatus for plating, the method for manufacturing an intracranial pressure sensor probe further comprises the steps of:
step S310: the housing 110 is immersed in the cleaning liquid to be cleaned, and the remaining cleaning liquid is cleaned after the cleaning is completed.
Referring to fig. 5, it will be understood that, before the coating of the housing 110, i.e., before the step S110 is performed, the step S310 of this embodiment may be performed, i.e., cleaning of the housing 110 is required, which aims to clean the metal surface of the housing 110 of possible particulate matter or organic contamination, and then the residual cleaning liquid is removed by washing with deionized water and dried.
Optionally, the cleaning working fluid adopts organic solvents such as acetone, isopropanol or alcohol.
Optionally, the degreasing working fluid is heated before immersing the housing 110 in the cleaning working fluid for cleaning. It can be understood that the heated oil removal working solution can accelerate the oil removal speed to a certain extent, thereby improving a certain oil removal effect.
Further, when the housing 110 is immersed in the cleaning liquid to perform cleaning, ultrasonic-assisted cleaning is performed. The ultrasonic auxiliary cleaning can strengthen the oil removal effect to a certain extent.
As shown in FIG. 5, after the step of plating the housing 110 in the plating apparatus, the method for manufacturing the intracranial pressure sensor probe further comprises the steps of:
step S410: the housing 110 is subjected to a plasma surface treatment.
Referring to fig. 5, it can be understood that after the step S110 is performed, the housing 110 may be subjected to a plasma surface treatment to improve the surface bonding force of the coating layer 170. After the plasma surface treatment is completed, a silicone cover 180 (e.g., silicone or epoxy) is applied and cured.
Optionally, the plasma surface treatment mode comprises normal pressure glow discharge or vacuum etching.
Optionally, the plasma surface treated working gas comprises oxygen, argon, carbon tetrafluoride or sulfur hexafluoride. In some other embodiments, the working gas may also employ a combination of the above-described gases.
As shown in fig. 3, the pressure sensor assembly includes a relative pressure sensor chip 120, a first wire 130, and a second wire 140; as shown in FIG. 5, prior to the step of installing the pressure sensor assembly into the housing 110 and aligning the detection window, the intracranial pressure sensor probe fabrication method further comprises the steps of:
step S510: welding one end of the first wire 130 to the pad 310 of the opposite pressure sensor chip 120 to form a first welding spot 150, wherein the first wire 130 is a bare wire, and the opposite pressure sensor chip 120 forms a free end through the first wire 130;
step S520: and directly welding one end of the second wire 140 with the other end of the first wire 130 to form a second welding point 160 to obtain the pressure sensor assembly, wherein the second wire 140 is an enameled wire, and one end of the second wire 140 is a bare area.
It will be appreciated that a pressure sensor assembly needs to be fabricated prior to performing step S120. Specifically, as can be seen from fig. 3, after step S510 is performed, a first solder joint 150 is formed between the first wire 130 and the pad 310 of the opposite pressure sensor chip 120 by soldering, and specifically referring to fig. 6, the solder paste of the first solder joint 150 is covered on the pad 310 of the opposite pressure sensor chip 120.
With continued reference to fig. 3, after step S520 is performed, the other end of the first conductive wire 130 is soldered to one end of the second conductive wire 140 to form the second solder joint 160. The second solder joint 160 may be formed by an omni-directional solder ball bond, i.e., the solder is fully encapsulated to encapsulate the exposed area of the second wire 140 end. It should be appreciated that after the second solder joint 160 is soldered, the second conductive wire 140 also has a portion exposed around the second solder joint 160, and the exposure deviation between batches is large due to the consistency of the soldering process, which results in different product precision of each batch, especially after a period of use of the product.
It should be noted that, since the relative pressure sensor chip 120 forms a free end through the first wire 130, when the pressure sensor assembly of the embodiment of the present invention is installed in the intracranial pressure sensor probe, the first wire 130 can ensure that the bottom of the relative pressure sensor chip 120 is suspended, thereby isolating most of mechanical stress and thermal stress, improving measurement accuracy and reducing pressure drift. Meanwhile, the number of welding spots in the assembly manufacturing process is reduced by directly welding the first wire 130 and the second wire 140, and the reliability of the process and the product is ensured.
Further, as shown in fig. 3, the second wire 140 is configured as an enamel wire, the middle portion of which is wrapped with an insulating layer, while the end portion is exposed, while the first wire 130 is a pure bare wire. Therefore, after the first wire 130 is welded to the opposite pressure sensor chip 120, the second wire 140 is welded to the first wire 130, so that the welding process by an operator can be better facilitated, the assembly efficiency and the product yield can be improved, and the stress of the second wire 140 to the opposite pressure sensor chip 120 can be reduced, compared with the direct welding of the second wire 140, which is an enameled wire, to the opposite pressure sensor chip 120, by using the first wire 130, which is a bare wire, for transition.
As shown in fig. 5, the conformal corrosion protection layer is formed once for the presence of a bare metal surface in the pressure sensor assembly, comprising the steps of:
step S121: immersing the pressure sensor assembly in an electroplating solution to perform anti-corrosion treatment on the corrosion-prone region to realize conformal electroplating, wherein the electroplating layer is entirely wrapped around the corrosion-prone region, the pressure sensor assembly is used as a cathode, and the corrosion-prone region comprises a first lead 130, a first welding point 150, a second welding point 160 and a bare region.
In order to ensure that the welded internal circuit is not affected by the water vapor permeation in actual use, the process continues to step S121. Specifically, the pressure sensor assembly is placed as a cathode in a plating solution, and an electroplating treatment is performed using, for example, graphite, a platinum-plated titanium mesh/sheet, or an iridium-plated titanium mesh/sheet as an inert anode, thereby forming an anti-corrosion layer (not shown in the drawing). By adopting the electroplating method, the corrosion resistance of the internal circuit is greatly improved, and the metal protection can be realized in all conducting areas through the same process. Thus enabling the pressure sensor assembly to avoid erosion of the electrical circuit by corrosive body fluids and to ensure biocompatibility and reliability. In addition, the problem of larger exposure deviation among batches can be well solved through effective protection of the anti-corrosion layer.
Further, since the anti-corrosion layer of the embodiment of the invention is of an integral conformal electroplating structure and has conductivity, the process requirements and difficulties of the second welding spot 160 of the first welding spot 150 can be obviously reduced; in addition, the materials of the first wire 130 and the second wire 140 may be selected from materials having general corrosion resistance and low cost, such as common copper, silver or alloys thereof, composite layers, and the like, compared with the prior art.
It should be noted that, fig. 5 is a flowchart of a preferred embodiment provided by the present invention, and implementation steps of the preferred embodiment may be understood as follows: firstly, step S310, step S210 and step S220 are performed to clean the housing 110 and put in a fixture to prepare for coating; then, step S110 is performed to coat the housing 110 to form a coating layer 170, and step S410 is performed to perform surface treatment on the housing 110; then, performing step S510, step S520 and step S121 to finish the welding between the relative pressure sensor chip 120, the first wire 130 and the second wire 140, so as to obtain a pressure sensor assembly preliminarily, and performing anti-corrosion treatment on the corrosion-prone region of the pressure sensor assembly; finally, step S130 and step S140 are performed to assemble the pressure sensor assembly into the housing 110 and cover the silicone cover 180. It will be appreciated that the preferred embodiment is only one of several examples, and thus, step S310 and steps S210, S220 are performed as a plurality of steps performed before step S110, in no order.
In addition, as shown in fig. 3, the embodiment of the present invention further provides an intracranial pressure sensor probe, the intracranial pressure sensor probe comprising: housing 110, coating 170, pressure sensor assembly, and silicone jacket 180. The housing 110 is provided with a containing space inside, and the housing 110 is provided with at least a detection window; the coating layer 170 is formed at least on the outer surface of the housing 110 around the detection window; the pressure sensor component is arranged in the accommodating space and aligned with the detection window, and a conformal anti-corrosion layer is formed on the exposed metal surface of the pressure sensor component; the silica gel supporting layer 180 is filled in the detection window, is attached to the coating layer 170, and is used for conducting pressure to the pressure sensor assembly.
Alternatively, the housing 110 is made of biocompatible metal or alloy material, and the specific material may be titanium or titanium alloy. It can be appreciated that silica gel has good biocompatibility, adhesion and insulation; meanwhile, the formed silica gel supporting layer 180 also has certain flexibility, so that pressure transmission to the pressure sensor assembly can be realized.
Optionally, the coating layer 170 includes at least one of a silicon oxide film layer, a silicon nitride film layer, and an aluminum oxide film layer. Specifically, the coating layer 170 may be a silicon dioxide single film layer, a silicon nitride single film layer, or an aluminum oxide single film layer; the structure of a multilayer structure consisting of a silicon dioxide single film layer, a silicon nitride single film layer or an aluminum oxide single film layer can also be adopted to form a composite film layer.
Referring to fig. 3, the opening of the detection window has an inclined surface to form a necking structure gradually shrinking from outside to inside. It can be appreciated that, compared with the detection window with the inner side wall being a vertical surface, the inner side wall of the detection window is set to be an inclined surface, so that the deposition of the coating layer 170 around the detection window is more facilitated, that is, the maximization of the contact surface between the silica gel supporting layer 180 and the coating layer 170 is ensured, and the firm adhesion between the silica gel supporting layer 180 and the housing 110 is realized.
With continued reference to fig. 3, the housing 110 is further provided with a wire connection port, and the pressure sensor assembly includes: the opposing pressure sensor chip 120, the first wire 130, the second wire 140, and the corrosion protection layer. The relative pressure sensor chip 120 is disposed in the accommodating space; the first wire 130 has a chip connection end and a wire connection end, the chip connection end is welded with the opposite pressure sensor chip 120 and forms a first welding spot 150, the first wire 130 is arranged as a bare wire, the first wire 130 is arranged in the accommodating space, and the opposite pressure sensor chip 120 forms a free end through the first wire 130; the second wire 140 is set as an enameled wire, one end of the second wire 140 is an exposed area, the exposed area and the wire connection end are directly welded to form a second welding spot 160, one end of the second wire 140 is arranged in the accommodating space, the other end of the second wire 140 extends to the outside through the wire connection port, and an air passage communicated with the wire connection port is formed below the relative pressure sensor chip 120; the anti-corrosion layer is configured to form a conformal electroplated layer at one time by electroplating equipment, and is entirely wrapped around the first wire 130, the first welding spot 150, the second welding spot 160 and the exposed area.
It is to be understood that the pressure sensor assembly of the present embodiment includes, but is not limited to, a relative pressure sensor chip 120, a first wire 130, and a second wire 140. Specifically, the relative pressure sensor die 120 may be a strain-type pressure sensor, a capacitive pressure sensor, or a piezoelectric pressure sensor, preferably a piezoresistive pressure sensor.
With continued reference to FIG. 6, the pressure sensitive membrane 330 is disposed on the opposing pressure sensor chip 120, and the pressure sensitive membrane 330 is configured to receive the transmitted intracranial pressure, so that the internal circuit 320 can convert the intracranial pressure into a corresponding pressure value, so with reference to FIG. 3, it can be appreciated that the pressure sensitive membrane 330 is disposed in a detection window oriented with respect to the housing 110, so as to collect intracranial pressure information; with continued reference to fig. 3, the second wire 140 may extend from the wire connection port to the outside; the silicone rubber cover 180 is fitted and filled in the window and covers the opposite pressure sensor chip 120.
By mounting the pressure sensor assembly within the housing 110, indirect contact of the pressure sensor assembly with the intracranial space is achieved through the detection window, such that an intracranial pressure value is obtained, enabling intracranial pressure monitoring. By providing a silicone jacket 180, direct contact with the cranium can be achieved to transfer pressure to the pressure sensor assembly.
In addition, as shown in fig. 3, a silicone support layer 180 is embedded on one side of the opposing pressure sensor chip 120, and the other side is in the air passage communicating with the lead connection port. It should be noted that, the relative pressure sensor chip 120 performs measurement based on the atmospheric pressure, so the inner side of the relative pressure sensor chip 120 of the embodiment of the present invention needs to be in contact with the atmosphere, i.e. suspended into the air passage. The embodiments of the present invention ensure good operation of the relative pressure sensor chip 120 and may significantly reduce product costs compared to using an absolute pressure sensor chip.
In addition, in some other embodiments, the first wire 130 has better flexibility than the second wire 140, and is more convenient to be soldered to the opposite pressure sensor chip 120, thereby reducing soldering difficulty and improving assembly efficiency. The greater flexibility of the first wire 130 means that it has greater bending capability, i.e., is more flexible to operate, under the same force. That is, the first wire 130 is a relatively "soft wire" and the second wire 140 is a relatively "hard wire". The first conductive line 130 and the second conductive line 140 may be made of different materials to achieve different flexibility, or the first conductive line 130 may be thinner when the same materials are used. In addition, in the embodiment shown in fig. 3, the first conductive wire 130 and the second conductive wire 140 are linear, and may also take various curved shapes to achieve different postures with respect to the pressure sensor chip 120, which is not limited thereto.
Alternatively, the first wire 130 may be a bare wire such as a gold wire, a silver-plated copper wire, a gold-plated copper wire, a silver-copper alloy wire, or the like. The first welding spot 150 or the second welding spot 160 may be welded by ultrasonic bonding, solder paste welding, resistance welding, laser soldering, or the like. The embodiment of the invention can effectively prevent each wire and welding spot from being corroded, and has more obvious effect on materials such as copper, tin, silver and the like which are easy to corrode.
Furthermore, according to some embodiments of the present invention, as shown in fig. 3, the core diameter of the second wire 140 is larger than the diameter of the first wire 130. In particular, referring to fig. 3, it can be appreciated that by providing the first wire 130 with a smaller diameter than the core material of the second wire 140, the first wire 130 is more flexible and less likely to break. In some embodiments, the copper core diameter (neglecting the lacquer layer) of the second wire 140 is 20 micrometers to 200 micrometers and the diameter of the first wire 130 is 10 micrometers to 100 micrometers.
Further, the length of the first wire 130 is 0.2 to 2 mm, and the length of the second wire 140 is 0.3 to 3 m. It should be noted that, since the first wire 130 is a bare wire and needs to be electroplated, the length of the first wire 130 is reasonably set to be 0.2 mm to 2 mm based on the consideration of cost and assembly convenience; since the second wire 140 is a wire extending to the outside to be connected to an external circuit, a relatively longer wire may be used, so that the length of the second wire 140 is reasonably set to 0.3 to 3 meters.
Preferably, the second wire 140 may be a direct-welding type enamel wire, and when the direct-welding type enamel wire is used, the second wire 140 does not need to be subjected to a paint removing operation during welding; in some other embodiments, when the second wire 140 is a non-straight wire, the stripping operation may be performed by laser stripping, paint stripper dipping, mechanical stripping, or the like.
Referring to fig. 6 in combination, the first and second wires 130 and 140 are provided in plurality, and the number of the first and second wires 130 and 140 is the same. The second wires 140 are preferably a plurality of sequentially fixed flat cable structures. For the opposite pressure sensor chip 120 requiring external power supply, one power supply line must be connected, and two positive and negative output lines are required, so that three first and second wires 130 and 140 are required, respectively. It is understood that the three first wires 130 are soldered to the pads 310 of the opposite pressure sensor chip 120 in parallel, and each of the pads 310 is electrically connected to the internal circuit 320 by a different wire.
Optionally, the corrosion-resistant layer is a gold plating, a palladium plating, or a platinum plating (preferably bright platinum). Specifically, the components of the gold plating solution include, but are not limited to, sodium gold sulfite, the components of the palladium plating solution include, but are not limited to, diammine palladium chloride, and the components of the platinum plating solution include, but are not limited to, platinum dinitrosulfate.
Optionally, the corrosion protection layer has a thickness of 0.025 micrometers to 10 micrometers. It will be appreciated that by reasonably setting the thickness of the corrosion protection layer to 0.025 to 10 microns, on the one hand, the protection effect can be ensured, and on the other hand, the risk of breakage due to too-brittle plating caused by too-thick corrosion protection layer can be prevented.
The pressure sensor assembly of the present embodiment further includes a transition layer disposed between the corrosion protection layer and the corrosion susceptible region, the transition layer configured to enhance adhesion between the corrosion protection layer and the substrate, the corrosion susceptible region including the first conductive line 130, the first solder joint 150, the second solder joint 160, and the exposed region. Specifically, a pretreatment, specifically, a pre-plating treatment may be performed before the plating treatment is performed to form the anti-corrosion layer. The plating material is easy to deposit on the surface of the base material during electroplating, so that the plating layer is loose and has poor binding force. Therefore, a transition layer with good binding force is plated on the surface of the base material in advance in a preplating mode, so that the adhesion between the subsequent anti-corrosion layer and the base material is enhanced.
Preferably, the transition layer is a nickel plating layer. Specifically, by performing pre-plating with a nickel plating solution, a nickel plating layer can be formed. In some embodiments, the composition of the nickel plating solution includes, but is not limited to, electroplated nickel. In some embodiments, the transition layer has a thickness of 1 micron to 10 microns.
According to some embodiments of the present invention, there is a bare internal circuit 320 of the relative pressure sensor chip 120, and the pressure sensor assembly further includes a protective covering (not shown) that covers the bare internal circuit 320. For example, there may be a bare portion of the internal circuit 320 on the surface of the relative pressure sensor chip 120, and therefore, it is necessary to perform an insulating protection treatment on the portion before plating, that is, form a protective layer, so as to prevent the problem that the metal plated later comes into contact with the internal circuit 320 to affect the measurement accuracy. In some embodiments, the insulation protection treatment may be implemented by a manner of silica gel protection, vapor deposition of an insulation layer, and the like.
In addition, as shown in fig. 7, the intracranial pressure sensor probe further includes: a temperature sensor 410, a third wire 420. The temperature sensor 410 is disposed in the housing 110; one end of the third wire 420 is electrically connected to the temperature sensor 410, and the other end extends to the outside through the wire connection port. It will be appreciated that by providing the temperature sensor 410, monitoring of intracranial temperature conditions may be further achieved on the basis of monitoring intracranial pressure.
In some embodiments, the third wire 420 is provided in plurality. Further, if the temperature sensor 410 uses a thermistor, two wires need to be disposed at two ends of the thermistor to provide voltage, that is, two wires need to be disposed at the third wire 420.
It will be appreciated that in the embodiment of fig. 3 and 7, the housing 110 has a regular square structure, which is only schematically illustrated, and that a person skilled in the art can conceive various modifications of the housing 110 on the basis of this, and the invention is not limited thereto. In addition, fig. 3 and 7 only illustrate the probe portion of the intracranial pressure monitor, and other portions such as a host computer, a drainage tube, etc. can refer to the existing and improved technology.
While embodiments of the present invention have been shown and described, it will be understood by those of ordinary skill in the art that: many changes, modifications, substitutions and variations may be made to the embodiments without departing from the spirit and principles of the invention, the scope of which is defined by the claims and their equivalents.
Claims (10)
1. The manufacturing method of the intracranial pressure sensor probe is characterized by comprising the following steps of:
placing the shell in a coating device for coating so as to form a coating layer at least on the outer surface around a detection window of the shell; the coating layer is made of hydrophilic materials, and the surface of the coating layer contains free hydroxyl;
forming a conformal corrosion protection layer on the exposed metal surface in the pressure sensor assembly at one time;
mounting the pressure sensor assembly into the housing and aligning the detection window;
and filling the silica gel protective layer into the detection window to be attached to the coating layer, wherein the silica gel protective layer is used for conducting pressure to the pressure sensor component.
2. The method of manufacturing an intracranial pressure sensor probe according to claim 1, wherein before the step of placing the housing in a plating apparatus for plating, the method further comprises the steps of:
placing the shell on a clamp base and enabling the detection window to face upwards;
placing a clamp upper cover on the clamp base to fix the housing;
the clamp comprises a clamp base, a shell, a clamp cover and a clamp cover, wherein the clamp base is provided with a containing groove, the containing groove is used for containing the shell, a limiting groove and a hollowed-out window are formed in the clamp cover, the limiting groove is used for fixing the shell, and the hollowed-out window is aligned with the detection window.
3. The method of manufacturing an intracranial pressure sensor probe according to claim 1, wherein before the step of placing the housing in a plating apparatus for plating, the method further comprises the steps of:
immersing the shell into a cleaning working liquid for cleaning, and cleaning the residual cleaning working liquid after the cleaning is completed.
4. The method of manufacturing an intracranial pressure sensor probe according to claim 1, wherein after the step of placing the housing in a plating apparatus for plating, the method of manufacturing an intracranial pressure sensor probe further comprises the steps of:
and carrying out plasma surface treatment on the shell.
5. The method of making an intracranial pressure sensor probe as recited in any one of claims 1 to 4, wherein the pressure sensor assembly comprises a relative pressure sensor chip, a first lead, and a second lead; before the step of mounting the pressure sensor assembly into the housing and aligning the detection window, the intracranial pressure sensor probe fabrication method further comprises the steps of:
welding one end of the first wire to a bonding pad of the opposite pressure sensor chip to form a first welding spot, wherein the first wire is a bare wire, and the opposite pressure sensor chip forms a free end through the first wire;
and directly welding one end of the second wire with the other end of the first wire to form a second welding spot so as to obtain the pressure sensor assembly, wherein the second wire is an enameled wire, and one end of the second wire is a bare area.
6. The method of manufacturing an intracranial pressure sensor probe according to claim 5, wherein the conformal corrosion protection layer is formed once for the exposed metal surface in the pressure sensor assembly, comprising the steps of:
immersing the pressure sensor component in electroplating liquid to perform anti-corrosion treatment on an easily-corroded area so as to realize conformal electroplated layers at one time, wherein the electroplated layers are entirely wrapped around the easily-corroded area, the pressure sensor component is used as a cathode, and the easily-corroded area comprises the first lead, the first welding point, the second welding point and the exposed area.
7. An intracranial pressure sensor probe, the intracranial pressure sensor probe comprising:
the shell is internally provided with an accommodating space, and at least one detection window is formed in the shell;
the coating layer is at least formed on the outer surface of the shell around the detection window; the coating layer is made of hydrophilic materials, and the surface of the coating layer contains free hydroxyl;
the pressure sensor component is arranged in the accommodating space and aligned with the detection window, and a conformal anti-corrosion layer is formed on the exposed metal surface of the pressure sensor component;
and the silica gel support layer is filled in the detection window, is attached to the coating layer and is used for conducting pressure to the pressure sensor assembly.
8. The intracranial pressure sensor probe as recited in claim 7, wherein the opening of the detection window has a bevel to form a constriction that tapers from outside to inside.
9. The intracranial pressure sensor probe as recited in claim 7, wherein the housing is further provided with a wire connection port, and the pressure sensor assembly comprises:
the relative pressure sensor chip is arranged in the accommodating space;
the first lead is provided with a chip connecting end and a lead connecting end, the chip connecting end is welded with the opposite pressure sensor chip and forms a first welding point, the first lead is arranged as a bare wire, the first lead is arranged in the accommodating space, and the opposite pressure sensor chip forms a free end through the first lead;
the second wire is arranged as an enameled wire, one end of the second wire is an exposed area, the exposed area is directly welded with the wire connecting end to form a second welding spot, one end of the second wire is arranged in the accommodating space, the other end of the second wire extends to the outside through the wire connecting port, and an air passage communicated with the wire connecting port is formed below the relative pressure sensor chip; the anti-corrosion layer is arranged to realize conformal electroplated layers at one time through electroplating equipment, and is integrally wrapped on the first lead, the first welding spot, the second welding spot and the exposed area in a surrounding mode.
10. The intracranial pressure sensor probe as recited in any one of claims 7 to 9, wherein the coating layer comprises at least one of a silicon dioxide film layer, a silicon nitride film layer, and an aluminum oxide film layer.
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| CN111391335A (en) * | 2020-03-21 | 2020-07-10 | 宿州德源服装有限公司 | Bonding process of silica gel and PET |
| CN113321833A (en) * | 2021-06-18 | 2021-08-31 | 杭州普惠医疗器械有限公司 | Method for improving detection response time of intracranial pressure sensor and intracranial pressure sensor |
| CN114760912A (en) * | 2019-12-04 | 2022-07-15 | 丹参生物电子私人有限责任公司 | Implantable stimulator with electrode array and compliant substrate |
| CN116652381A (en) * | 2023-07-17 | 2023-08-29 | 广州见微医疗科技有限公司 | Method for manufacturing intracranial pressure probe |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE102005020569B4 (en) * | 2005-04-30 | 2010-08-05 | Aesculap Ag | Implantable device for detecting intracorporeal pressures |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5993395A (en) * | 1996-04-18 | 1999-11-30 | Sunscope International Inc. | Pressure transducer apparatus with disposable dome |
| CN114760912A (en) * | 2019-12-04 | 2022-07-15 | 丹参生物电子私人有限责任公司 | Implantable stimulator with electrode array and compliant substrate |
| CN111391335A (en) * | 2020-03-21 | 2020-07-10 | 宿州德源服装有限公司 | Bonding process of silica gel and PET |
| CN113321833A (en) * | 2021-06-18 | 2021-08-31 | 杭州普惠医疗器械有限公司 | Method for improving detection response time of intracranial pressure sensor and intracranial pressure sensor |
| CN116652381A (en) * | 2023-07-17 | 2023-08-29 | 广州见微医疗科技有限公司 | Method for manufacturing intracranial pressure probe |
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