CN114451891A

CN114451891A - Probe for measuring physiological signals and method for manufacturing the same

Info

Publication number: CN114451891A
Application number: CN202210125456.5A
Authority: CN
Inventors: 林明杰; 郑贻实
Original assignee: Isoman Zhongshan Medical Equipment Co ltd
Current assignee: Isoman Zhongshan Medical Equipment Co ltd
Priority date: 2022-02-10
Filing date: 2022-02-10
Publication date: 2022-05-10

Abstract

The invention discloses a probe for measuring physiological signals and a manufacturing method thereof, which can be applied to the field of medical detection. The probe may include a gas-permeable casing and a hollow conduit connected to the casing, the casing integrally includes a first hole, a second hole and a third hole, and a portion of each of the first sensor, the second sensor and the third sensor is inserted into and mounted in the first hole, the second hole and the third hole, respectively. The probe comprises a plurality of sensors and has the advantages of high structural integration level and simple structure.

Description

Probe for measuring physiological signals and method for manufacturing the same

Technical Field

The invention relates to a physiological signal detection device, in particular to a physiological signal detection probe.

Background

With the development of medicine, more and more scenes are needed to detect physiological signals. For example, monitoring physiological signals of intracranial or other tissue fluids during surgery has become an important adjunct to surgical treatment. Because of the special physiological environment of intracranial tissue fluid or other tissue fluids, higher and higher requirements are put forward on the structure and the function of a physiological signal detection device.

For the detection of intracranial tissue fluid or other tissue fluids, the existing physiological signal detection device has the problems of single detection parameter, complex structure and the like, and cannot well meet the requirement.

Disclosure of Invention

The invention aims to provide a probe for measuring physiological signals, which is used for detecting a plurality of different physiological parameters, and has the advantages of high and simple structure integration level and easy manufacture. Can be widely applied to the field of detection of physiological signals of intracranial tissue fluid or other tissue fluids and the like.

Another object of the present invention is to provide a method of manufacturing a probe for measuring physiological signals, in which the probe can be easily manufactured by a simple process.

A first aspect of the invention provides a probe for measuring physiological signals, in some embodiments the probe comprises: a mantle having gas permeability and a hollow conduit connected to the mantle. The overcoat film integrally has a first hole, a second hole and a third hole, and a portion of each of the first sensor, the second sensor and the third sensor is inserted into and mounted in the first hole, the second hole and the third hole, respectively.

The first, second and third sensors are mounted in the integrally formed first, second and third holes, so that the integration of the overcoat film and the three sensors can be easily realized, and the structure is simple and easy to assemble.

In some embodiments, a direction perpendicular to a radial direction of the overcoat film is set as an axial direction, and the overcoat film has a cross section perpendicular to the axial direction through which the first hole, the second hole, and the third hole penetrate.

As the first hole, the second hole and the third hole are formed in one cross section, the radial space is effectively utilized, the space occupied in the axial direction can be shortened, and the advantage of saving space is achieved.

In some embodiments, in cross-section, at least two of the first, second, and third holes are arranged along a radial direction.

Due to the adoption of the structure that the two holes or the three holes are arranged along the radial direction, the arrangement is orderly, the positioning and the installation are convenient, and the balance of the whole structure of the probe is convenient to realize even if the diameters of the holes are different.

In some embodiments, the first bore, the second bore, and the third bore each extend in an axial direction.

The layout that the first hole, the second hole and the third hole respectively extend along the axial direction of the overcoat film is adopted, so that the sensors assembled in the holes work independently and do not influence each other.

In some embodiments, the first sensor, the second sensor, and the third sensor are a gas content sensor, a temperature sensor, and a pressure sensor, respectively.

Since the first sensor, the second sensor and the third sensor are different sensors, the detection of multiple parameters such as specific gas content, temperature and gas pressure can be realized at the same time.

In some embodiments, a sensing end of the gas content sensor containing the gas indicator is inserted into the first bore, and an optical fiber connected to a proximal side of the sensing end extends proximally from the first bore. An air chamber is formed in the first hole on the distal side of the sensing end. The gas content sensor is capable of measuring the content of a particular gas within the gas cell.

Because the air chamber is formed in the first hole, the outer sleeve film has specific gas permeability, and external specific gas enters the probe through the outer sleeve film, so that the gas content sensor arranged in the outer sleeve film of the probe can sense the corresponding gas content.

In some embodiments, the gas content sensor is an oxygen content sensor.

Because the gas content sensor is an oxygen content sensor, the oxygen content of intracranial tissue fluid or other tissue fluid can be sensed, and intracranial hypoxia or low oxygen content of other physiological tissues can be prevented.

In some embodiments, the third hole includes a window portion and the window portion is covered with a thin film capable of deforming according to pressure. The pressure sensing end of the pressure sensor is mounted to the third hole in such a manner that a portion thereof corresponds to the window portion, and the pressure is measured through the film.

Due to the adoption of the third hole structure and the corresponding assembly mode of the film and the pressure sensor. The pressure sensor can sense the external pressure by the stress deformation of the film, so that the detection of the pressure parameter is realized.

In some embodiments, the pressure sensing end of the pressure sensor is connected to a pressure sensing line via a connection point, the pressure sensing line extending proximally from the third aperture.

Because the pressure sensor is connected with the pressure sensing line through the connecting point, the electric signal generated by the pressure sensor can be stably transmitted to the pressure sensing line.

In some embodiments, the temperature sensor is a contact temperature sensor. The pressure sensor is a piezoelectric pressure sensor. The gas indicator is a fluorescent dye sensitive to oxygen. The material of the mantle comprises polydimethylsiloxane or a composition containing the polydimethylsiloxane. The film is any one of silicon rubber, polyethylene, teflon and tetrafluoroethylene.

By adopting the contact type temperature sensor, the temperature detection of intracranial tissue fluid and other tissue fluids can be realized by measuring the temperature of the outer sleeve die. By adopting the piezoelectric pressure sensor, high detection sensitivity can be realized, and the piezoelectric pressure sensor is compatible with nuclear magnetic resonance, so that the probe can be widely applied to the field of medical detection. By adopting the fluorescent dye sensitive to oxygen, the oxygen content detection of intracranial tissue fluid and other tissue fluids can be realized, and hypoxia of tissues is avoided. The overcoat film is made of the known material, satisfies the gas permeability, has a certain strength and flexibility, and can fix and support the sensors without placing an excessive burden on the human body or the like. The membrane is made of known materials and can transmit pressure while protecting the pressure sensor.

A second aspect of the present invention provides a method of manufacturing a probe according to the first aspect, the method comprising: injection molding the mantle; connecting the mantle and the hollow conduit; and inserting a first sensor, a second sensor and a third sensor into the first hole, the second hole and the third hole, respectively.

In some embodiments, the connection of the mantle to the hollow conduit includes a mechanical connection, a glue connection, and a hybrid connection combining a mechanical connection and a glue connection.

The invention has the beneficial effects that:

in the invention, the probe for measuring the physiological signal adopts an integrated design, and has the characteristics of simple manufacturing process and easy mass production. Meanwhile, a plurality of sensors which are orderly arranged are wrapped in the outer sleeve of the probe, the sensors are reasonable in layout, the space is saved, the size of the probe is further reduced, and the probe is suitable for various application scenes.

In addition, the probe for measuring physiological signals can also realize the measurement of a plurality of physiological parameters of intracranial physiological tissues or other physiological tissues.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.

Drawings

FIG. 1 is a schematic diagram of a probe for measuring physiological signals in an embodiment of the present invention;

FIG. 2 is a cross-sectional view taken along line I-I of FIG. 1;

FIG. 3 is a cross-sectional view taken along line II-II of FIG. 1;

FIG. 4 is a schematic diagram of a process for manufacturing a mantle of the probe according to an embodiment of the present invention.

Description of reference numerals:

1-mantle fiber; 2-a sensing end comprising a gas indicator; 3-an optical fiber; 4-a film; 5-a pressure sensor sensing end; 6-temperature sensor sensing end; 7-a distal pallium end; 8-a pressure sense line; 9-temperature sensing wire; 10-air chamber; 11-a connection point; 12-a hollow conduit; 13-probe.

Detailed Description

Embodiments of the present invention will be described below with reference to the drawings. It will be appreciated by those skilled in the art that the specific configurations, dimensions, and proportions shown in the drawings are exemplary and are intended to be exaggerated in detail in order to facilitate an understanding of the embodiments of the present invention, and are not intended to limit the scope of the claims which follow.

In this specification, reference to proximal and distal positions is made to an implant, unless specifically stated otherwise. Specifically, when the probe for measuring physiological signals is implanted, one end of the probe, which is positioned outside the implant body, is a proximal end, and the other end of the probe is a distal end.

In order to explain the technical means of the present invention, the following description will be given by way of specific examples.

With the development of medicine, monitoring physiological signals of intracranial tissue fluid or other tissue fluids in surgery becomes an important auxiliary means for surgical treatment. For example, in treating a patient using craniotomy or extracerebral drainage, it is desirable to measure intracranial pressure and oxygen content. If the intracranial pressure is increased or the oxygen content is reduced, the patient needs to be treated in time. Otherwise, the patient may have too high intracranial pressure, which may cause the heart to be unable to deliver blood to the brain, resulting in hypoxia of the brain, brain death or even death of the patient. Alternatively, the patient may experience intracranial hypoxia, which may result in decreased brain tissue activity, brain tissue damage, and even brain death. Therefore, higher and higher requirements are placed on the structure and function of the physiological signal detection device.

The pressure sensors currently include optical pressure sensors, piezoelectric pressure sensors, and bladder type pressure sensors. Compared with optical pressure sensors and air bag type pressure sensors, piezoelectric pressure sensors have the advantages of high signal-to-noise ratio, simple structure, high sensitivity, compatibility with nuclear magnetic resonance, easy compatibility with electronic equipment and the like, and therefore, the piezoelectric pressure sensor is a preferred pressure sensor for measuring physiological parameters of intracranial tissue fluid or other tissue fluids.

Gas content sensors currently include electrochemical gas content sensors and optical gas content sensors. In which, compared to electrochemical gas content sensors, optical gas content sensors have the characteristics of no gas consumption, short response time, and no need for frequent repetitive corrections, and thus optical gas sensors are a preferred gas sensor for measuring physiological parameters of intracranial tissue fluids or other tissue fluids. Optical gas sensors often measure gas in tissue fluids by fluorescence quenching, in which the gas in tissue fluids is attached to a fluorescence quenching substance, which causes the fluorescence quenching substance to have a characteristic anisotropic reaction with the gas, and the gas content is measured by fluorescence detection.

Because the composition of intracranial tissue fluid or other tissue fluids is similar to that of blood plasma, but the content of protein and cholesterol is low, and other ions such as sodium, chlorine, magnesium, hydrogen ions and the like are contained. Therefore, when measuring physiological signals of intracranial tissue fluid or other tissue fluids, it should be avoided that the tissue fluid composition is directly attached to the surface of the preferred pressure sensor and the preferred gas content sensor, which may cause the reading value of the sensor to drift or the measurement to be inaccurate.

In order to solve the above problems, embodiments of the present invention provide a probe for measuring physiological signals. When the probe is used, intracranial tissue fluid or other tissue fluid can be inserted. The multi-physiological parameter detection is realized through the combined action of various sensors in the probe, and the probe has a prospect of being widely applied to the field of physiological signal detection.

The following description is made

Embodiments of the invention.

The probe for measuring physiological signals of the present invention may include a mantle having gas permeability and a hollow conduit connected to the mantle. The overcoat film integrally has a first hole, a second hole and a third hole, and a portion of each of the first sensor, the second sensor and the third sensor is inserted into and mounted in the first hole, the second hole and the third hole, respectively.

It is understood that the gas permeable overcoat film is permeable to a particular gas and is resistant to water vapor, interstitial fluid, and the like. The material of the hollow conduit is not limited herein. The connection mode of the mantle and the hollow conduit can adopt the connection modes of mechanical connection, glue joint connection, mixed connection combining the mechanical connection and the glue joint connection, and the like.

In some possible embodiments, a direction perpendicular to the radial direction of the overcoat film is set as the axial direction. The mantle has a cross section perpendicular to the axial direction, through which the first hole, the second hole and the third hole all penetrate.

It should be understood that the radial direction of the mantle does not include the radial direction of the closed circular face of the distal end of the mantle.

In some possible embodiments, at least two of the first, second, and third apertures are radially aligned in the cross-section of the probe.

It should be understood that the arrangement of the holes can be set according to actual requirements. Due to the adoption of the structure that the two holes or the three holes are arranged along the radial direction, the arrangement is orderly, the positioning and the installation are convenient, and the balance of the whole structure of the probe is convenient to realize even if the diameters of the holes are different.

In some possible embodiments, the first bore, the second bore, and the third bore each extend in an axial direction.

It should be understood that the first hole, the second hole and the third hole are used for assembling the sensor, and the three holes extend along the axial direction, so that the sensor can be reasonably arranged, and the space is saved.

In some possible embodiments, the first sensor, the second sensor and the third sensor are a gas content sensor, a temperature sensor and a pressure sensor, respectively.

It should be understood that since the first sensor, the second sensor and the third sensor are different sensors, respectively, the detection of multiple parameters such as specific gas content, temperature and gas pressure can be simultaneously achieved.

In some possible embodiments, the sensing end of the gas content sensor containing the gas indicator is inserted into the first hole. An optical fiber connected to a proximal side of the sensing tip extends proximally from the first aperture. A gas chamber is formed in the first hole on the distal end side of the sensing end, and the gas content sensor can measure the content of the specific gas in the gas chamber.

It should be understood that, since the gas chamber is formed in the first hole and the mantle has a specific gas permeability, the external specific gas enters the interior of the probe through the mantle, so that the gas content sensor arranged in the mantle of the probe can sense the corresponding gas content.

The above description of the proximal side of the sensing tip and the optical fiber is a nomenclature used to distinguish between the various features of the gas content sensor. The sensing tip containing the gas indicator and the optical fiber may be the same optical fiber. I.e. the same optical fibre, one end of which is coated with the gas indicator, the end coated with the gas indicator may be named the sensing end containing the gas indicator, while the opposite end is named the optical fibre.

The gas content sensor can detect the gas content and comprises a sensing end part containing a gas indicator and an optical fiber, and also comprises a light source emission source, a light source receiving source and the like which are used for matching with the gas content detection.

The hole reserved in the overcoat film and the gas content sensor inserted into the hole form tight enclosure, and the hole also reserves a space for realizing the gas chamber at the sensing end part of the gas content sensor.

In some possible embodiments, the gas content sensor is an oxygen content sensor.

It should be understood that since the gas content sensor is an oxygen content sensor, the oxygen content sensor is sensitive to oxygen, and can sense the oxygen content of intracranial tissue fluid or other tissue fluid, and prevent intracranial hypoxia or other physiological tissue oxygen content from being too low.

In some possible embodiments, the third hole comprises a window and the window is covered by a film that is deformable in response to pressure. The pressure sensing end of the pressure sensor is mounted to the third hole in such a manner that a portion thereof corresponds to the window portion, and the pressure is measured through the film.

It will be appreciated that the third aperture arrangement described above is used, as well as the corresponding mounting of the membrane and pressure sensor. The pressure sensor can sense the external pressure by the stress deformation of the film, so that the detection of the pressure parameter is realized.

In some possible embodiments, the pressure sensing end of the pressure sensor is connected to the pressure sensing line via a connection point, and the pressure sensing line extends proximally from the third bore.

It should be understood that the electrical signal generated by the pressure sensor is transmitted to the external data processing center by the pressure sensing line, so as to realize the sensing of the pressure.

In some possible embodiments, the temperature sensor is a contact temperature sensor. The pressure sensor is a piezoelectric pressure sensor. The gas indicator is a fluorescent dye sensitive to oxygen. The material of the mantle comprises polydimethylsiloxane or a composition containing the polydimethylsiloxane. The film is any one of silicon rubber, polyethylene, teflon and tetrafluoroethylene.

It will be appreciated that by using the contact temperature sensor described above, temperature sensing of intracranial tissue fluid and other tissue fluids can be achieved by measuring the temperature of the outer sheath. By adopting the piezoelectric pressure sensor, high detection sensitivity can be realized, and the piezoelectric pressure sensor is compatible with nuclear magnetic resonance, so that the probe can be widely applied to the field of medical detection. By adopting the fluorescent dye sensitive to oxygen, the oxygen content detection of intracranial tissue fluid and other tissue fluids can be realized, and hypoxia of tissues is avoided. The overcoat film is made of the known material, satisfies the gas permeability, has a certain strength and flexibility, and can fix and support the sensors without placing an excessive burden on the human body or the like. The membrane is made of known materials and can transmit pressure while protecting the pressure sensor.

A possible embodiment of the present invention will be described in detail below with reference to fig. 1 to 3. Fig. 1 is a schematic structural diagram of a probe for measuring physiological signals according to an embodiment of the present invention, and referring to fig. 1, a probe 13 includes a mantle 1 and a hollow catheter 12, and the mantle 1 is connected with the hollow catheter 12. The overcoat film 1 integrally has a closed circular surface (i.e., the overcoat film front end 7) and three holes. A direction perpendicular to the radial direction of the overcoat film 1 was set as an axial direction, and the three holes each extended along the axial direction of the overcoat film 1.

In addition, one end of the probe positioned outside the implant body is defined as a proximal end, and the other end is defined as a distal end. The axial direction of the overcoat film 1 is equivalent to the direction from the proximal end of the overcoat film 1 to the distal end of the overcoat film 1, or the axial direction of the overcoat film 1 is equivalent to the direction from the distal end of the overcoat film 1 to the proximal end of the overcoat film 1.

The three holes are closed at the distal end and open at the proximal end. The length of the three holes is not particularly limited, and may be specifically set according to circumstances as long as the sensor described later can be stably mounted and is suitable for implantation in a target position. As for the shape of the three holes, it may have an inner surface shape matching the outer shape of the accommodated sensor, and of course, other shapes are possible as long as the basic function thereof can be achieved.

The gas content sensor, the temperature sensor and the pressure sensor are respectively inserted into the three holes, namely the gas content sensor, the temperature sensor and the pressure sensor respectively extend along the axial direction of the outer coating film 1, the inserted end is a far end, and the opposite end is a near end.

Wherein the gas content sensor comprises a sensing end 2 containing a gas indicator and an optical fiber 3. The proximal end of the optical fiber 3 is connected to a central control and calculation unit (not limited in this application), not shown, and the distal end of the optical fiber 3 is connected to the proximal end of the sensing end 2 containing the gas indicator, and the distal end of the sensing end 2 containing the gas indicator is inserted into the corresponding hole and forms an air chamber 10 with the mantle 1.

The temperature sensor comprises a temperature sensor sensing end 6 and a temperature sensing lead 9. The proximal ends of the temperature sensing wires 9 are connected to a central control and calculation unit, not shown, and the distal ends of the temperature sensing wires 9 are connected to the proximal ends of the temperature sensor sensing ends 6, and the distal ends of the temperature sensor sensing ends 6 are inserted into the corresponding holes and brought into close contact with the mantle 1.

The pressure sensor comprises a pressure sensor sensing end 5, a connection point 11 and a pressure sensing line 8. The proximal end of the pressure sensing line 8 is connected to a not shown central control and calculation unit, and the distal end of the pressure sensing line 8 is connected to the proximal end of the pressure sensor sensing end 5 via a connection point 11. The hole into which the pressure sensor is inserted includes a window portion covered with the film 4, and the pressure sensor sensing end 5 is mounted to the inserted hole in such a manner that a portion thereof corresponds to the window portion, and the pressure is measured through the film.

FIG. 2 is a cross-sectional view taken along line I-I of FIG. 1; fig. 3 is a sectional view taken along line ii-ii of fig. 1. As shown in the cross-sectional view along line I-I of fig. 2, it is apparent from the cross-sectional view of the probe 13 that the mantle 1 wraps the sensing end 2 containing the gas indicator, the pressure sensing end 5 and the temperature sensing end 6, and that the sensing end 2 containing the gas indicator, the pressure sensing end 5 and the temperature sensing end 6 are arranged along the same radial direction according to the positions of the three holes in the mantle 1. As shown in the cross-sectional view along line ii-ii of fig. 3, it is apparent in the cross-sectional view of the probe 13 that the optical fiber 3, the pressure sensing wire 8 and the temperature sensing wire 9 are located in the hollow guide tube 12, and the optical fiber 3, the pressure sensing wire 8 and the temperature sensing wire 9 are arranged in the same radial direction. The probe 13 uses the positional relationship of the gas content sensor, the temperature sensor and the pressure sensor shown in fig. 2 and 3, which is more advantageous for saving the assembly space.

In some possible embodiments, the positions of the three holes of the overcoat film 1 may be arranged according to actual requirements, so as to ensure that at least two holes are arranged along the radial direction.

The analysis shows that the probe structure provided by the embodiment of the invention is reasonable in layout and space-saving, can be provided with various sensors, realizes multi-physiological-parameter detection, and has wide application scenes.

Next, a method of manufacturing the probe having the above-described structure will be described. The method comprises the following steps: injection molding the mantle; connecting the mantle and the hollow conduit; and inserting a first sensor, a second sensor and a third sensor into the first hole, the second hole and the third hole, respectively.

First, a manufacturing process of the overcoat film of the probe is described.

Fig. 4 is a schematic flow chart of a manufacturing process of a mantle of a probe according to an embodiment of the present invention, and referring to fig. 4, the mantle is manufactured by an injection molding process. Specifically, the outer coating film manufacturing process can be divided into the following steps: (a) and manufacturing a mold and a mold cover. (b) And (6) pouring glue. (c) And covering the mold cover. (d) After the glue is cured, the mold cover is removed. (e) And taking the mantle out of the mold.

In some possible embodiments, the mold and the mold cover may be made of a high temperature resistant material that can be formed into a fixed shape. For example: polylactic acid (PLA) or a metal. Here, the mold has, for example, an outer contour corresponding to the shape of the first hole, the second hole, and the third hole in the overcoat film, respectively. The mold may be integrally connected with the mold cover.

Furthermore, the glue filled into the mould is solidified into the mantle, so the material of the glue can be selected from polydimethylsiloxane or a composition containing polydimethylsiloxane.

In some possible embodiments, the main agent A of the dimethyl siloxane colloid and the curing agent B can be mixed to form the dimethyl siloxane colloid, the colloid is poured into a mold and then covered by a mold cover, the mold cover is placed at the temperature of 70-80 ℃ for a period of time and then annealed, and the overcoat film is manufactured after the film is removed after the annealing is finished.

From the analysis, the method for manufacturing the mantle is simple in process, the die can be recycled, and mass production is easy to realize.

Finally, some possible methods of use of the probe of the present invention are described.

Before using the probe 13, the air cell 10 is filled with air, and a light source emission source, not shown, and a light source reception source, not shown, are coupled to the optical fiber 3.

In use, the probe 13 is first inserted into a patient, and the probe 13 will be surrounded by intracranial tissue fluid or other tissue fluid (for convenience of description, tissue fluid will be uniformly exemplified below).

In one aspect, since the mantle 1 is selected to have a material that blocks all but the corresponding gas, only the corresponding gas (hereinafter, uniformly exemplified by oxygen for convenience of description) can enter the gas cell 10, and neither water vapor, liquid nor interstitial fluid can enter the gas cell 10. After oxygen diffuses from external tissue fluid to the gas chamber 10 through the mantle 1, the original reflection states of the light source receiving source not shown and the light source emitting source not shown are changed due to the unique sensitivity of the sensing end 2 containing the gas indicator to oxygen, for example, the increase of the oxygen content reduces the excitation intensity of light, and the metering of the oxygen concentration is realized by a central control and calculation unit not shown. Further, since the oxygen concentration in the gas chamber 10 is the same as the oxygen concentration of the tissue fluid, the oxygen concentration in the gas chamber 10 is detected to be equal to the detected value of the oxygen concentration of the tissue fluid by the probe 13.

On the other hand, the film 4 covering the window of the hole into which the pressure sensor is inserted may be deformed by the change in the tissue fluid pressure. Further, the shape change of the film 4 presses the pressure sensing end 5, so that the impedance of the pressure sensing end 5 is changed. The impedance changes are quantified as electrical signals and transmitted via the pressure sensing leads 8 to a central control and calculation unit, not shown, to detect changes in tissue fluid pressure.

In another aspect, the sensing end 6 of the temperature sensor is closely connected to the mantle 1, and the temperature of the mantle 1 changes with the temperature of the tissue fluid, i.e. the sensing end 6 of the temperature sensor can sense the temperature of the tissue fluid by sensing the temperature of the mantle 1. Further, the temperature sensor sensing terminal 6 will cause the impedance of the sensor itself to change due to the temperature change, so that the temperature sensor sensing terminal 6 will change electrically, and the electrical property will be transmitted to the central control and calculation unit, not shown, by the temperature sensing wire 9 to detect the change of tissue temperature.

The analysis shows that the probe for measuring the physiological signals adopts an integrated structure, is simple in use method, can measure a plurality of physiological parameters simultaneously, and is easy to popularize and use.

In addition, the pressure and the gas concentration have certain correlation with the temperature, and the probe is assembled with the temperature sensor to sense the temperature, so that the error generated by the pressure and the gas concentration can be compensated through the temperature, and the detection accuracy is improved.

The embodiments of the present invention have been described above. It should be understood by those skilled in the art that the foregoing description and drawings are illustrative and are not intended to limit the scope of the invention. The protection scope of the invention is subject to the claims.

Claims

1. A probe for measuring physiological signals,

the probe comprises a mantle membrane with gas permeability and a hollow conduit connected with the mantle membrane,

the overcoat film integrally has first hole, second hole and third hole, and first sensor, second sensor and third sensor are some respectively insert install in first hole, the second hole with the third hole.

2. The probe for measuring physiological signals according to claim 1,

a direction perpendicular to a radial direction of the overcoat film is set as an axial direction,

the outer sleeve is provided with a cross section which is perpendicular to the axial direction and is penetrated by the first hole, the second hole and the third hole.

3. A probe for measuring physiological signals according to claim 2, wherein in the cross-section at least two of the first, second and third apertures are arranged in a radial direction.

4. The probe for measuring physiological signals according to claim 2 or 3,

the first bore, the second bore and the third bore extend along the axial direction, respectively.

5. The probe for measuring physiological signals according to claim 1,

the first sensor, the second sensor and the third sensor are respectively a gas content sensor, a temperature sensor and a pressure sensor.

6. The probe for measuring physiological signals according to claim 5,

the sensing end part of the gas content sensor containing the gas indicator is inserted into the first hole,

an optical fiber connected to a proximal side of the sensing tip extends proximally from the first bore,

an air chamber is formed in the first hole on the distal end side of the sensing end portion,

the gas content sensor is capable of measuring the content of a particular gas within the gas chamber.

7. The probe for measuring physiological signals according to claim 5 or 6,

the gas content sensor is an oxygen content sensor.

8. The probe for measuring physiological signals according to claim 5,

said third hole comprising a window portion and said window portion being covered by a pressure-deformable membrane,

a pressure sensing end portion of the pressure sensor is attached to the third hole in such a manner that a portion thereof corresponds to the window portion, and pressure is measured through the thin film.

9. The probe for measuring physiological signals according to claim 8,

the pressure sensing end of the pressure sensor is connected to a pressure sensing line via a connection point, the pressure sensing line extending proximally from the third bore.

10. The probe for measuring physiological signals according to claim 6,

the temperature sensor is a contact temperature sensor;

the pressure sensor is a piezoelectric pressure sensor;

the gas indicator is a fluorescent dye sensitive to oxygen;

the material of the mantle comprises polydimethylsiloxane or a composition containing polydimethylsiloxane;

the film is any one of silicon rubber, polyethylene, teflon and tetrafluoroethylene.

11. A method of manufacturing a probe as claimed in any of claims 1 to 10, comprising:

injection molding the mantle;

connecting the mantle and the hollow conduit; and

inserting a first sensor, a second sensor and a third sensor into the first hole, the second hole and the third hole, respectively.

12. The method of claim 11, wherein the coating is attached to the hollow conduit by a mechanical bond, a glue bond, or a hybrid bond combining a mechanical bond and a glue bond.