CN112545474A - Measurement kit for physiological parameter induction diagnosis - Google Patents
Measurement kit for physiological parameter induction diagnosis Download PDFInfo
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- CN112545474A CN112545474A CN202110073235.3A CN202110073235A CN112545474A CN 112545474 A CN112545474 A CN 112545474A CN 202110073235 A CN202110073235 A CN 202110073235A CN 112545474 A CN112545474 A CN 112545474A
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- stimulator
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- 230000006698 induction Effects 0.000 title claims abstract description 20
- 238000003745 diagnosis Methods 0.000 title claims abstract description 16
- 238000005259 measurement Methods 0.000 title claims abstract description 11
- 210000000214 mouth Anatomy 0.000 claims abstract description 22
- 230000033001 locomotion Effects 0.000 claims abstract description 16
- 238000003860 storage Methods 0.000 claims abstract description 12
- 230000001681 protective effect Effects 0.000 claims abstract description 11
- 230000001939 inductive effect Effects 0.000 claims description 19
- 239000002861 polymer material Substances 0.000 claims description 10
- 239000011664 nicotinic acid Substances 0.000 claims description 8
- 238000009423 ventilation Methods 0.000 claims description 4
- 238000006243 chemical reaction Methods 0.000 claims description 3
- 210000003128 head Anatomy 0.000 claims description 3
- 230000003321 amplification Effects 0.000 claims description 2
- 238000001914 filtration Methods 0.000 claims description 2
- 238000003199 nucleic acid amplification method Methods 0.000 claims description 2
- 238000012545 processing Methods 0.000 claims description 2
- 229910000679 solder Inorganic materials 0.000 claims 1
- 238000001514 detection method Methods 0.000 abstract description 7
- 239000012567 medical material Substances 0.000 abstract description 2
- 230000001953 sensory effect Effects 0.000 abstract description 2
- 238000004519 manufacturing process Methods 0.000 description 8
- 239000000463 material Substances 0.000 description 5
- 238000000034 method Methods 0.000 description 5
- 229920002635 polyurethane Polymers 0.000 description 5
- 239000004814 polyurethane Substances 0.000 description 5
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- 231100000252 nontoxic Toxicity 0.000 description 4
- 230000003000 nontoxic effect Effects 0.000 description 4
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- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 3
- 238000011156 evaluation Methods 0.000 description 3
- 238000001125 extrusion Methods 0.000 description 3
- 239000003292 glue Substances 0.000 description 3
- 238000002347 injection Methods 0.000 description 3
- 239000007924 injection Substances 0.000 description 3
- 238000001746 injection moulding Methods 0.000 description 3
- 210000002445 nipple Anatomy 0.000 description 3
- 230000000241 respiratory effect Effects 0.000 description 3
- 239000000741 silica gel Substances 0.000 description 3
- 229910002027 silica gel Inorganic materials 0.000 description 3
- 238000005476 soldering Methods 0.000 description 3
- 238000004891 communication Methods 0.000 description 2
- 238000012544 monitoring process Methods 0.000 description 2
- 238000007789 sealing Methods 0.000 description 2
- 238000004659 sterilization and disinfection Methods 0.000 description 2
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- 208000001848 dysentery Diseases 0.000 description 1
- 238000000407 epitaxy Methods 0.000 description 1
- 230000004634 feeding behavior Effects 0.000 description 1
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- 238000004806 packaging method and process Methods 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
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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
- A61B5/45—For evaluating or diagnosing the musculoskeletal system or teeth
- A61B5/4538—Evaluating a particular part of the muscoloskeletal system or a particular medical condition
- A61B5/4542—Evaluating the mouth, e.g. the jaw
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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
- A61B5/0048—Detecting, measuring or recording by applying mechanical forces or stimuli
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/03—Measuring fluid pressure within the body other than blood pressure, e.g. cerebral pressure ; Measuring pressure in body tissues or organs
- A61B5/036—Measuring fluid pressure within the body other than blood pressure, e.g. cerebral pressure ; Measuring pressure in body tissues or organs by means introduced into body tracts
- A61B5/038—Measuring oral pressure
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Veterinary Medicine (AREA)
- Biophysics (AREA)
- Pathology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Public Health (AREA)
- Physics & Mathematics (AREA)
- Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Dentistry (AREA)
- Hematology (AREA)
- Physical Education & Sports Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Rheumatology (AREA)
- Measuring And Recording Apparatus For Diagnosis (AREA)
Abstract
The invention relates to a measurement kit for physiological parameter induction diagnosis, which mainly comprises a physiological induction stimulator (1), an extension tube (2), a pressure transmitter (4), a storage module (5), a data interface (6), a matched integrated circuit (7) and a protective shell (8). The disposable medical consumable has the advantages that the disposable medical consumable can effectively stimulate the oral cavity of a newborn, induce the newborn to generate oral cavity movement and detect the physiological parameters of the oral cavity movement in real time, the subjectivity of the existing sensory detection and judgment is avoided, and the blank of medical materials in the detection field is filled.
Description
Technical Field
The invention relates to a measurement kit for physiological parameter induction diagnosis, which is a disposable consumable for monitoring physiological parameters in the process of inducing newborn oral cavity movement by medical institutions, and belongs to the field of medical instruments.
Background
The neonatal oral motion rating scale (NOMAS) is a current tool for evaluating and diagnosing neonatal oral motion, developed successfully in 1985 by Braun et al, St.Paul medical institute, Braun et al, 1993, and used clinically to date after revision by Palmer et al. The instrument assesses the oral cavity motor ability of the neonate based on 28 items such as tongue and cheek movement and rhythm during suckling by observing the feeding behavior of the neonate. At present, the common evaluation method for the oral cavity movement of the newborn clinically is that medical staff puts fingers into the oral cavity of the newborn to stimulate the oral cavity of the newborn to induce the newborn to generate the oral cavity movement, and the medical staff obtains physiological parameters such as the response time of the oral cavity movement, the number of respiratory pulses per minute, the duration time of the respiratory pulses, the interval time of the respiratory pulses, the pressure in the oral cavity and the like through senses. Therefore, the existing evaluation tools and means are relatively laggard, the obtained result has strong subjectivity, and laboratory tools and credible detection data are lacked.
Disclosure of Invention
The invention provides a measurement kit for physiological parameter induction diagnosis, which is matched with physiological parameter induction diagnosis equipment for use and provides a safe and effective disposable consumable for clinical evaluation.
A measurement kit for physiological parameter induction diagnosis mainly comprises a physiological induction stimulator, an extension tube, a pressure transmitter, a storage module, a data interface, a matched integrated circuit and a protective shell. Wherein:
the physiological inducing stimulator is a bionic appliance made of medical soft polymer materials and has the function of stimulating the oral cavity of the newborn and inducing the newborn to generate oral cavity movement. The middle of the physiological inducing stimulator is provided with an air channel, for example, the air channel of the physiological inducing stimulator penetrates through the head and the tail of the physiological inducing stimulator. The physiological inducing stimulator is one of bionic fingers or a bionic nipple, and is formed at one time by adopting a medical soft high polymer material mold manufacturing and producing process, wherein the medical soft high polymer material which can be adopted comprises non-toxic materials such as natural latex, silica gel, polyurethane and the like.
The extension tube is a hollow tube communicated with the physiological inducing stimulator and the pressure measuring interface of the pressure transmitter. The extension pipe is made of medical soft polymer material by extrusion molding and is cut into a pipe with the length of 10cm-30 cm; the adopted medical soft high polymer materials comprise nontoxic materials such as natural latex, silica gel, polyurethane and the like. One end of the extension tube is closely connected with the tail of the ventilation cavity of the physiological inducing stimulator, and the other end of the extension tube is connected with a pressure measuring interface of the pressure transmitter. The physiological inducing stimulator and the extension tube directly enter the oral cavity of the newborn and are generally provided aseptically in clinical use. Because the medical polymer material and the electronic components are selected in different disinfection modes, in order to facilitate the independent disinfection treatment of the physiological induction stimulator and the extension tube, the extension tube is preferably connected with the pressure measuring interface of the pressure transmitter by a conversion joint quickly. The specific shape of the adapter is not limited by a horn shape, a cone shape or a Ruhr interface, the adapter is produced by adopting a medical high polymer material (including natural latex, silica gel, polyurethane and other non-toxic materials) mould process, and the sealing performance can be ensured after the adapter is quickly connected with a pressure measuring interface of a pressure transmitter.
The pressure transmitter mainly comprises a load cell sensor, a measuring circuit and a load measuring interface. Generally, the range of the pressure transmitter is-40 kPa-0, the precision grade is +/-0.5%, the stability is +/-0.2% F.S, and a pressure measuring interface of the pressure transmitter is quickly connected with an extension pipe and has good tightness.
The storage module is an electronic component for storing UDI information written by a production enterprise and hospital clinical information. The UDI (Unique device identification) is a Unique identifier of a medical device specified by the national drug administration, and is composed of a device identification code (DI) and a production identification code (PI), wherein the device identification code is a code that is forcibly fixed and includes information of a tag administrator, a device specific version or model, and the product identification code includes information of a device production lot number, a serial number, a production date, and a failure date. When the implementation case is put into clinical application, after the implementation case is connected with a computer and/or a matched physiological parameter induction diagnosis device, medical personnel input clinical use information into a storage module, wherein the clinical use information specifically comprises patient identity information, a bed number and a hospital number; the clinical use information also comprises non-rewritable information automatically written into the storage module during the detection of the physiological parameter induction diagnosis device, wherein the non-rewritable information comprises the use date, the use duration, the use times (such as the use times) and the data obtained by the detection.
The data interface is used for connecting and communicating with a computer and/or a matched physiological parameter inducing diagnosis device, and is generally connected with the communication interface of the computer and/or the physiological parameter inducing diagnosis device by adopting a data extension line. The specific type of data interface includes but is not limited to various versions of USB interface, IEEE1394 interface, HDMI interface, etc.; preferably, the data interface is a USB interface.
The matched integrated circuit is mainly composed of a PCB board and a signal amplification and filtering processing element, and the pressure transmitter, the storage module and the data interface are welded on the matched integrated circuit.
The protective shell is used for external protection of the matched integrated circuit and the internal components, and the matched integrated circuit and the internal components are fixedly arranged in the protective shell. The outer side of the protective shell is provided with a pressure measuring interface of the pressure transmitter for quick connection with the extension pipe; the outer side of the protective shell is also provided with a window of the data interface, so that the window is conveniently and quickly connected with a data extension line. The protective shell is generally processed by adopting a non-toxic high polymer material injection molding process.
The invention has the advantages that the disposable medical consumable can effectively stimulate the oral cavity of a newborn, induce the newborn to generate oral cavity movement and detect the physiological parameters of the oral cavity movement in real time. The embodiment case is matched with physiological parameter induction diagnosis equipment for use, provides a laboratory means for monitoring oral cavity movement physiological parameters, avoids the subjectivity of the existing sensory detection and judgment, and fills the gap of medical materials in the detection field. Meanwhile, the storage module realizes effective binding of the UDI information and the clinical use information of the implementation case, so that the implementation case can be traced from production and manufacturing to the whole process of clinical application, the repeated use or the cross use of disposable medical consumables is avoided, the clinical safety and effectiveness are ensured, and the implementation case has good clinical significance and use value.
Drawings
FIG. 1 is a schematic structural view of the present invention
FIG. 2 is a schematic diagram of the application of the present invention
Shown in the figure: the physiological induction stimulator comprises a physiological induction stimulator (1), an extension tube (2), a conversion joint (3), a pressure transmitter (4), a storage module (5), a data interface (6), a matched integrated circuit (7), a protective shell (8), physiological parameter induction diagnostic equipment (9) and a data extension line (10).
Detailed Description
The present invention will be described in detail with reference to the accompanying drawings and examples.
Example 1: an example of a product preparation protocol of the present invention
1. As shown in figure 1, the physiological induction stimulator (1) is designed into a bionic nipple shape, an air channel with an inner diameter of 2mm and a run-through end to end is arranged in the middle of the bionic nipple, and a switching groove with an inner diameter of 5mm and a depth of 6mm is arranged at the tail of the air channel for bonding an extension tube with the switching groove; an injection mold is opened, the injection mold is produced by adopting an injection molding process, and the medical soft polyurethane material is selected to process the physiological inducing stimulator (1) for standby.
2. As shown in figure 1, a set of polymer extrusion dies is designed, and the outer diameter of the extruded pipe is 4.8mm, and the inner diameter is 3.0 mm. Adopting precise pipeline extrusion equipment, selecting medical soft polyurethane material to produce pipes, cutting the pipes into lengths of 20cm, and producing extension pipes (2) for later use.
3. As shown in fig. 1, a set of injection molds of the adapter (3) is provided, and the adapter (3) is horn-shaped; the inner diameter of the part, which is bonded with the extension tube (2), of the adapter (3) is 5mm, the depth of the part is 6mm, the inner diameter of an opening of the part, which is rapidly connected with a pressure measuring interface of the pressure transmitter (4), of the adapter (3) is 8mm, the depth of the opening is 15mm, and the adapter gradually closes up and is reduced to the inner diameter of 5 mm. And an injection molding production process is adopted, and the adapter (3) is produced for standby.
4. According to the structure of figure 1, the physiological inducing stimulator (1), the extension tube (2) and the adapter (3) are sequentially bonded by medical glue. And after the medical glue is naturally dried, checking the connection strength, keeping the firm connection and the sealing of each bonding part under the tension of 10N, and keeping for later use after the medical glue is checked to be qualified.
5. The pressure measuring element sensor of the pressure transmitter (4) adopts a full-epitaxy MPS-2303-006GC model, a measuring range pressure sensor is-40 kPa-0, and the stability is +/-0.2% F.S; the pins of the pressure transmitter (4) are fixed on the matched integrated circuit (7) in a surface mounting mode, and the pressure measuring interface of the pressure transmitter (4) is exposed out of the protective shell (8) and can be effectively connected with the extension pipe.
6. The memory module (5) adopts an AT24C64 memory chip, and pins of the memory module (5) are fixed on the matched integrated circuit (7) in a patch mode.
7. The data interface (6) adopts a standard USB2.0 female head, and pins of the data interface (6) are fixed on the matched integrated circuit (7) in a surface mount manner.
8. After the pressure transmitter (4), the storage module (5) and the data interface (6) are pasted on the matched integrated circuit (7), the circuit is checked, and defects such as insufficient soldering, missing soldering, continuous soldering and the like do not exist. And after the inspection is qualified, the data interface is packaged in the protective shell (8), and the data interface (6) is completely exposed.
9. And (3) connecting the adapter (3) with a pressure measuring interface of the pressure transmitter (4), quickly connecting, checking to be sealed and leak-free, packaging, and sterilizing.
Example 2: examples of clinical applications of the invention
1. The data interface (6) of the finished product prepared in the embodiment 1 is effectively connected with a communication port of physiological parameter induction diagnosis equipment (9) by adopting a data extension line (10), and is started up to record identity information, bed numbers, hospitalization numbers and the like of the newborn.
2. The physiological inducing stimulator (1) is placed in the oral cavity of the newborn, the oral cavity movement of the newborn can be induced by stimulation by means of lifting, pulling and the like, and the physiological parameter inducing diagnostic equipment (9) dynamically detects the relevant parameters of the oral cavity movement of the newborn, reads out, records and outputs.
Although the present invention has been described in detail with reference to the preferred embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the spirit and scope of the invention.
Claims (5)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110073235.3A CN112545474A (en) | 2021-01-20 | 2021-01-20 | Measurement kit for physiological parameter induction diagnosis |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110073235.3A CN112545474A (en) | 2021-01-20 | 2021-01-20 | Measurement kit for physiological parameter induction diagnosis |
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| Publication Number | Publication Date |
|---|---|
| CN112545474A true CN112545474A (en) | 2021-03-26 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202110073235.3A Pending CN112545474A (en) | 2021-01-20 | 2021-01-20 | Measurement kit for physiological parameter induction diagnosis |
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| Country | Link |
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| CN (1) | CN112545474A (en) |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105534225A (en) * | 2014-10-29 | 2016-05-04 | 无锡市永动电子科技有限公司 | Automatic constant temperature spoon for baby |
| CN107693032A (en) * | 2017-11-09 | 2018-02-16 | 西安汇智医疗集团有限公司 | A kind of neonate's sucking reflex ability evaluating system |
| CN215128566U (en) * | 2021-01-20 | 2021-12-14 | 西安汇智医疗集团有限公司 | Measurement kit for physiological parameter induction diagnosis |
-
2021
- 2021-01-20 CN CN202110073235.3A patent/CN112545474A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105534225A (en) * | 2014-10-29 | 2016-05-04 | 无锡市永动电子科技有限公司 | Automatic constant temperature spoon for baby |
| CN107693032A (en) * | 2017-11-09 | 2018-02-16 | 西安汇智医疗集团有限公司 | A kind of neonate's sucking reflex ability evaluating system |
| CN215128566U (en) * | 2021-01-20 | 2021-12-14 | 西安汇智医疗集团有限公司 | Measurement kit for physiological parameter induction diagnosis |
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