Inspection apparatus, method of manufacturing the same, and method of use

Abstract

The present invention relates to a probe device (1) for use in testing the pH of soft tissue, body fluid, or bone, as well as methods for making and using the same. The probe includes a tip sensing element (2), a sleeve element (3) for housing a sensor signal line (10) that terminates at one end of a sensor electrode (16) in the tip sensing element, and an insulating element (4, 5, 6, 7, 9) attached to the sleeve element, the insulating element having a layered structure formed of multiple insulating layers. The probe provides real-time data regarding the probe's operating parameters and the health of the soft tissue, body fluid, or bone, and can be used to generate physiological or pathological images. The present invention also relates to methods for making the probe device and testing its performance.

Description

Technical Field

[0001] The present invention relates to an inspection device in the form of a pH probe device, a method for manufacturing the same, and a method for using the same. More specifically, the present invention relates to such a device for use in evaluating the health or condition of soft tissue, the composition of body fluids, and the health or condition of bone by improving probe insertion techniques.

Background Art

[0002] Various devices for inspecting and monitoring the pH of tissues and body fluids are generally known. The applicant has found problems with the reading accuracy and reading stability of these devices, and thus has devised an improved pH sensor and disclosed it in Patent Document 1. Patent Document 1 relates to a pH sensor adapted to be inserted into soft tissues such as muscle and fat, or other organs such as the heart, lungs, kidneys, liver, pancreas, intestines, skin, and brain, and body fluids such as the digestive tract wall layer or blood, cerebrospinal fluid, urine, peritoneal fluid, synovial fluid, vitreous humor, and digestive tract contents.

[0003] Although the device of the applicant's previous application was an improvement over prior devices, the applicant has developed aspects of the device, a method for manufacturing the same, and a method for using the same, aiming for further improvement.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

[0005] According to an innovative aspect of the subject matter of the present invention, there is provided a probe device for use in inspecting the pH of soft tissue, body fluid, or bone, including a tip sensing component, a sleeve component for accommodating a sensor signal line that terminates at one end of a sensor electrode within the connected tip sensing component, and an insulating component provided on the sleeve component and having a layer structure formed of a plurality of insulating layers.

[0006] In this regard, the insulating component is intended to provide an insulating effect to the sleeve component relative to the tip sensing component. Preferably, the insulating component does not cover the tip sensing component in this respect.

[0007] The probe device may include one or more of the following optional features: Preferably, the insulating component includes an internal insulating component provided within the sleeve component. Preferably, an external insulating component is provided around the sleeve component.

[0008] Multiple layers of the insulating component may therefore be formed as one or more layers on both sides of the wall of the sleeve component. In some preferred embodiments, the multiple insulating layers may be formed of different materials. Alternatively, in certain embodiments, several multiple insulating layers may be formed of the same material.

[0009] Preferably, the insulating layer may be selected from a plastic material. Preferably, the insulating layer may be selected from one or more insulating LDPE, LLDPE co-extruded adhesive resin, block copolymer, or ceramics.

[0010] Preferably, one or more insulating layers may be provided with a binder such as an adhesive. In a preferred embodiment, a portion of the insulating layer may be isolated by a binder in the form of an adhesive. Suitable adhesives may include epoxy, acrylate, cyanoacrylate, silicone, and urethane.

[0011] In a preferred embodiment, the binder includes an epoxy material. Furthermore, a suitable binder may preferably be a cyanoacrylate adhesive. Furthermore, in certain embodiments, the binder is provided between the surfaces of the insulating components and between the surfaces of the sleeve components, or between the surfaces of the insulating components or between the surfaces of the sleeve components.

[0012] Preferably, the binder is provided with air pockets or gas voids to enhance its insulating effect. This may be achieved during manufacturing by underloading the binder onto the interface between adjacent probe components to form a layer with voids.

[0013] In a preferred embodiment, the insulating layer is not provided directly on the sleeve component. Preferably, one or more insulating layers are connected to the sleeve component by a binder. In this way, an air pocket can be formed that enhances the insulating effect. The binder component, such as epoxy adhesive itself, also contributes to the insulating effect.

[0014] Preferably, the sleeve component includes a capillary glass tube connected to the tip detection component. Preferably, a pair of concentric tubes extend into the capillary glass tube. The inner tube may optionally extend to the tip detection component, or optionally extend beyond the tip of the capillary glass tube.

[0015] Therefore, insulating components may provide insulation both around and inside the sleeve component. In this regard, external insulating components may take the form of one or more insulating layers provided around the sleeve component, and internal insulating components may include one or more insulating layers provided inside the sleeve component.

[0016] Therefore, the sensor signal wire can be insulated from the external environment relative to the tip sensing component, and the signal wire can be insulated from the inside of the sleeve component, which is roughly in the shape of a glass tube. Thus, by providing one or more insulating layers inside the sleeve component, another level of insulation is provided, namely insulation between the wire attached to the sensor and the inside of the sleeve component. The sleeve component is essentially surrounded or isolated by inner and outer insulating layers sealed with a binder, thereby enhancing the insulation between the sensor and the sleeve component. In this regard, sealing may be preferable if a binder is used to seal the ends of the insulating layers (inner and outer) in which the sleeve component is enclosed.

[0017] In this regard, the insulating component preferably extends along the sleeve component but does not extend beyond the tip sensing component. More preferably, the intermediate tube may extend around the sleeve component and the inner tube protruding from the sleeve component. In this respect, the intermediate tube may extend beyond the sleeve component. In this way, the risk of the signal wire contacting the sleeve component is avoided. When the sensor wire exits the sleeve component, the position of the wire is centered by the adhesive plug, thereby further reducing the risk of the sensor wire directly contacting the sleeve component.

[0018] Preferably, the main tube of the probe may extend around the intermediate tube, and the outer bushing extends around the main tube. Preferably, the pair of inner tubes are formed from GRILAMID®.

[0019] Preferably, the intermediate tube is formed from GRILAMID®. Preferably, the main tube of the probe is formed from PEBAX®. The outer bushing is preferably formed from PEBAX®.

[0020] Preferably, the tip detection component includes a glass sphere formed by heating pH-sensitive glass to 800-1000 °C to achieve an ideal viscosity that enables the formation of a glass wall thickness of the sphere between 0.15 mm and 0.4 mm.

[0021] Preferably, the thickness of the glass wall of the sphere is formed to be 0.2 mm or less. Preferably, the impedance of the glass sphere is less than 2 GΩ here. Preferably, the glass sphere is aged for at least three months, but the aging process may be accelerated using a chemical etching method. The impedance inspection indicates that the insulation of the sensor unit is maintained during the aging process.

[0022] Preferably, the ratio of the impedance of the glass sphere to the impedance of the insulating sleeve component is in the range of 1:5 to 1:9. In a preferred embodiment, the probe device includes a memory storage device that stores details of a full calibration performed on the probe device during manufacture. The full calibration during manufacture includes calibrating the probe device using at least two buffer solutions to plot the calibration curve or gradient of the probe device. In this regard, during use, the details of the calibration can be easily accessed and verified. For example, if the calibration curve has drifted, appropriate adjustments can be made, or if the drift is outside the allowable range, the probe device may be designated as inappropriate for use.

[0023] According to a further aspect of the present invention, there is provided a system for use in inspecting the pH of soft tissue, body fluid or bone, having one or more of the probe devices as defined above and a monitor device for communicating with each of the one or more probe devices to provide real-time data regarding the operating parameters of the probe and the health of soft tissue, body fluid or bone.

[0024] The monitor preferably has the function of inspecting the performance of the probe, failing the probe device if necessary, correcting the reading drift if necessary, and thereby effectively zeroing the probe device.

[0025] Preferably, the data can be recorded and stored on a monitoring device, where it can be downloaded and analyzed. Preferably, the monitoring device has multiple connections to each probe device. Preferably, unique probe data is held by a memory recording device having static memory incorporated into the connector of each probe device. The memory is preferably in the form of non-volatile memory that retains its contents even after the power is turned off. This data may include calibration data of the probe devices performed during the manufacture of the probe devices. The calibration data preferably relates to the full calibration of the probe devices, which was performed using at least two buffer solutions to create pH curves.

[0026] The monitoring device preferably periodically sends response command signals to each probe device connected thereto. This may be every second, but another suitable time interval may be used. Preferably, during initial startup, each probe device sends a response command signal in a sequence requiring multiple consecutive readings of the measurement parameter to confirm the stability of the measurement parameter. Preferably, the measurement parameter is pH. In this regard, the monitoring device preferably measures the mV signal and then converts the numerical value to a pH value.

[0027] A further aspect of the present invention provides a method for monitoring the pH of soft tissue, body fluid, or bone derived from an individual, comprising: inserting a plurality of pH probe devices as defined above into different locations of soft tissue, body fluid, or bone; monitoring the outputs of the plurality of pH probe devices; and comparing the outputs to create a physiological or pathological image of the individual. In this context, the individual includes humans or animals. The method may be used, for example, to monitor pathological lesions such as tumors (benign or malignant), abscesses, hematomas, seromas, or ganglia.

[0028] Preferably, the output is compared to a reference value at the location. In this regard, the reference value can be, for example, a value in a book, a comparison between an injured limb and an uninjured limb, or a comparison between a healthy organ or part of an organ and an unhealthy one.

[0029] In this regard, this method can be used to compare, for example, one leg with the other, one muscle group with the other, one kidney with the other, or different parts of the same organ that may be supplied by different blood vessels, such as the heart, brain, liver, or muscles. Furthermore, this method can be used to compare the pH of body fluids (for example, urine that is newly produced and enters the kidney's collecting system). Thus, this method can be used, for example, to determine how well one kidney is functioning compared to the other kidney or to a known reference value.

[0030] A further aspect of the present invention provides a method for forming a pH probe device having a glass sphere connected to a capillary tube, the method comprising forming the glass sphere by heating glass to 800-1000°C.

[0031] In this way, the glass can achieve a viscosity that allows the thickness of the glass walls of the formed sphere to be 0.2 mm or less. A further aspect of the present invention provides a method for forming a pH probe device having a glass sphere connected to a capillary tube, the method comprising providing a plurality of insulating material layers on the capillary tube.

[0032] Preferably, the multiple insulating material layers include different insulating plastics. Such layers may be provided around and inside the capillary tube, or around and inside the capillary tube.

[0033] Preferably, the insulating material layers are separated or isolated by a binder such as an adhesive, for example, an epoxy material. Such a binder may preferably have insulating properties of its own.

[0034] Preferably, a pair of concentric inner tubes are formed to extend into the capillary. Preferably, the tips of the capillary and the two inner tubes are sealed with epoxy adhesive to create a sealed insulating unit in which only the signal wires protrude into the lumen of the probe tube.

[0035] The sealing unit enhances the insulation of both the signal wires and the capillaries. The intermediate tube is preferably formed to extend around the capillary glass tube and the inner tube protruding from the capillary glass tube.

[0036] The main probe tube may be provided so as to extend around the intermediate tube, and the outer bushing may extend around the main probe tube. A sensor for measuring the pH of living tissue, body fluid, or bone is provided, comprising: a sensor body having a sensor chip formed at one end, the sensor body including a spherical glass sphere and a cylindrical glass capillary extending from the glass sphere, the sensor body being formed to include an internal cavity containing a reference buffer solution; an insulating structure formed around the capillary, the insulating structure comprising: one or more inner tubes formed from a first material and arranged axially within the total length of the capillary; a sensor wire arranged axially within one or more inner tubes, having a first end extending into the central part of the glass sphere and a second end extending beyond the capillary; an intermediate tube covering the capillary and one or more inner tubes, including the endpoint of the capillary overlapping with one or more inner tubes; a probe main tube extending beyond the intermediate tube and covering the intermediate tube, covering the insulated sensor wire; and an outer bushing covering the probe main tube of the insulating structure.

[0037] A particular advantage of the subject matter described in this application is a probe device aimed at providing improved and consistent reading accuracy and stability. This probe device is in a sterile, ready-to-use form, eliminating the need for calibration while also allowing for drift testing performed before use to avoid clinically significant errors, and the ability to perform drift fine-tuning before use as needed.

[0038] From a monitoring perspective, this device provides various alerts not currently found in other pH monitoring systems. Because it has multiple channels, for example, it can be used to monitor multiple locations on a patient simultaneously. The usage period and function of each probe are independent of the others.

[0039] Furthermore, this system has the advantage of being factory calibrated. Calibration immediately before use is time-consuming and carries the risk of errors such as mixing or mixing of buffers, which can lead to incorrect calibration and undesirable clinical outcomes.

[0040] A further aspect of the present invention provides a method for testing the performance of the probe device defined above, based purely on impedance testing of the probe device alone. In connection with this, as a result of the properties of the probe and the method of manufacturing it, such a probe device can eliminate the need for pH drift testing, thereby simplifying and accelerating performance testing in use.

[0041] As will be apparent to those skilled in the art, various embodiments of the present invention can be implemented individually or in combination with one or more other embodiments. Various embodiments of the present invention can be optionally provided in combination with one or more optional features of other embodiments of the present invention. Furthermore, optional features described in relation to one embodiment can typically be implemented individually or in combination with other features in different embodiments of the present invention. Any subject matter described herein can be combined with any other subject matter herein to form novel combinations.

[0042] Next, various aspects of the present invention will be described in detail with reference to the accompanying drawings. Further aspects, features, and advantages of the present invention will be readily apparent from the entire description, including drawings illustrating several exemplary aspects and embodiments. The present invention is also capable of other different embodiments and embodiments, and some of its details can be modified in various ways, all without departing from the scope of the invention. Thus, each embodiment described herein should be understood to have broad applicability and is intended to illustrate one possible way of carrying out the invention, and not to suggest that the scope of this disclosure, including the claims, is limited to that embodiment. Furthermore, the terms and expressions used herein are for illustrative purposes only and should not be construed as limiting. In particular, unless otherwise stated, the dimensions and numerical values ​​included herein are presented as examples illustrating one possible aspect of the claimed subject matter and do not limit this disclosure to any specific dimensions or numerical values ​​described. All numerical values ​​in this disclosure should be understood as being modified with “about”. All singular forms of elements or any other components described herein should be understood to include plural forms, and vice versa.

[0043] The terms “including,” “comprising,” “having,” “containing,” and “involving,” and their variations, are intended to be broad and include the subject matter, equivalents, and further subject matter not described therein, and are not intended to exclude other additives, components, integers, or steps. Similarly, the term “comprising” is considered synonymous with the terms “including” or “containing” in the applicable legal purposes. Thus, throughout the specification and claims, unless the context requires otherwise interpretation, the terms “comprise,” or their variations such as “comprises” or “comprising,” will be understood to mean including the integer or group of integers described, but not to exclude any other integer or group of integers.

[0044] Any discussion relating to documents, actions, materials, equipment, articles, etc., is included herein solely for the purpose of providing the context of the present invention. It is not implied or represented that any or all of these matters form part of the basis of the prior art or are common general knowledge in the art relating to the present invention.

[0045] In this disclosure, whenever a composition, element, or group of elements precedes the transitional phrase “comprising,” it is intended that the same element or group of elements precedes the transitional phrase “consisting essentially of,” “consisting,” “selected from the group of consisting of,” or “including,” or precedes the description of the composition, element, or group of elements, and vice versa. In this disclosure, it is intended that the words “usually” or “optionally” indicate optional or non-essential features of the invention that are present in certain embodiments but can be omitted from other embodiments without departing from the scope of the invention.

[0046] References to directions and positions, such as "up" and "down" and other directions, should be interpreted by those skilled in the art as indicating the orientation of the features shown in the drawings within the context of the described embodiments, and the invention should not be interpreted as limiting itself to a literal interpretation of its terms, but rather as it should be understood by those skilled in the art.

[0047] Next, embodiments of the present invention will be described below as examples with reference to the accompanying drawings. [Brief explanation of the drawing]

[0048] [Figure 1] This is a longitudinal cross-sectional view through the tip of the probe according to the present invention. [Figure 2] This is a cross-sectional view of the X-X section through the probe in Figure 1. [Figure 3] This figure shows a monitor connected to a probe according to the present invention. [Modes for carrying out the invention]

[0049] Probe structure and manufacturing method As shown in Figure 1, the pH sensor probe 1 broadly includes a glass sphere 2 connected to a glass capillary tube 3. The glass sphere comprises a tip sensing component and a capillary tube having a sleeve for housing a sensor signal line 10 terminated at one end of the sensor electrode 16. Although glass has been described in this embodiment, other suitable materials may be used where appropriate.

[0050] The glass sphere 2 has a diameter in the range of 1.6 to 1.8 mm. In a preferred embodiment, the glass sphere 2 may have a maximum diameter of substantially 1.8 mm. In this regard, the glass sphere is manufactured with high tolerances, including overall sphere shape, constant wall thickness, wall thinness, symmetry, and a limited connection to the glass capillary, in order to maintain the pH-sensitive properties of the glass sphere and improve the insulating properties of the glass sphere. As part of the microfabrication process, as will be described in more detail below, the glass sphere 2 is connected to the glass capillary 3, which forms the joint 14.

[0051] The dimensions of the pH sensor 1, glass bulb 2, and glass capillary tube 3 may be appropriately reduced and adjusted to suit the requirements of, for example, pediatric or neonatal applications or large / small animal requirements.

[0052] Preferably, the wall thickness of the glass sphere 2 is substantially 0.15 mm to 0.5 mm, more preferably 0.2 mm. It will be understood that in other applications of the pH sensor probe 1, different preferred wall thicknesses may be required for the glass sphere. The diameter of the glass capillary tube 3 is preferably 1.8 mm, and the preferred wall thickness is in the range of 0.08 to 0.12 mm. Preferably, the wall thickness of the glass capillary tube is substantially 0.1 mm. In this regard, it is desirable that the outer diameter of the capillary tube be approximately the same as or smaller than the diameter of the glass sphere.

[0053] In this regard, the diameter of the glass sphere is similar to, or preferably slightly smaller than, the outermost diameter of the capillary tube including any outer sleeve or bushing. In this way, the glass sphere is protected during insertion and removal.

[0054] In this regard, the glass sphere 2 is formed by high-precision blowing after heating to an extremely high temperature, i.e., in the range of 800-1000°C. In this method, the glass is relatively fluid and has a preferred viscosity, i.e., it allows for the desired wall thickness to be realized using a minimal amount of material. In this regard, the blowing (insufflation) of the glass sphere is preferably carried out using compressed air at 0.5 ATM (50662.5 Pa), so that this part of the manufacturing method involves a very delicate low-pressure process.

[0055] The thinner the glass of glass sphere 2, the faster its response to pH changes, i.e., when placed in a different pH environment. Furthermore, the more consistent the shape of the glass sphere, the more consistent its wall thickness becomes, which also improves the response speed because the larger surface area of ​​the sphere responds to changes in the surrounding pH.

[0056] The type of glass used for the sphere is pH-sensitive glass manufactured by CLR, and is therefore highly sensitive to hydrogen ions. The connection between the glass sphere 2 and the glass capillary tube 3 at the joint 14 is symmetrical and limited in order to maintain the pH-sensitive properties of the glass sphere 2 and improve its insulating properties.

[0057] The glass sphere 2 is formed using both a technique and glass material that results in a structure with very low impedance relative to the stem of the glass capillary tube 3, which is formed from a glass material with relatively high impedance, such as quartz glass.

[0058] Preferably, the impedance of the glass sphere is less than 2 GΩ, and the impedance of the glass capillary is greater than 10 GΩ. In some embodiments, the impedance of the glass sphere is preferably in the range of 1.0 to 2.5 GΩ.

[0059] In a preferred embodiment, the ratio of the impedance of the glass sphere 2 to the impedance of the glass capillary tube 3 is in the range of 1:5 to 1:9. The glass capillaries are preferably formed from quartz glass, which exhibits very high heat resistance. Quartz glass begins to soften at 1200–1600°C. At 800–1000°C, the flame temperature for heating the glass sphere is high enough to bring the pH-sensitive glass to a fairly molten state, but not enough to melt the glass capillaries. Therefore, a distinct / sharp transition exists between the two types of glass in contact. This sharp boundary helps maintain the insulating properties of the glass sphere.

[0060] During the manufacturing process, the connection or joint 14 between the glass sphere 2 and the glass capillary tube 3 is inspected at various stages to ensure uniform welding. Such inspections may be performed after the sphere is blown in, after the sensor unit is assembled, and after the final probe assembly is completed.

[0061] The glass sphere 2 is further aged to enhance the stability of the probe. The aging process begins when the glass capillary tube 3 is first attached to the glass sphere 2. The aging process can take up to three months or more, preferably a minimum of three months, and there is no effective maximum. The size of the pores in the glass becomes more consistent through aging, whether through natural aging or accelerated aging in some way. In this respect, the glass acts as a semipermeable membrane.

[0062] Aging can be a natural process, or it can be accelerated (for example, by chemical methods). This may involve using 5% hydrofluoric acid. Ultimately, because the entire surface area of ​​glass sphere 2 responds to changes in ambient pH, the size of the glass pores in glass sphere 2 becomes constant, improving the stability of probe readings and optimizing responsiveness to pH changes and reading accuracy.

[0063] Impedance testing of a structure combining a glass sphere and a capillary tube is used to confirm that the insulation of the sensor unit is maintained during the aging process, such that the impedance of the glass sphere is kept below 2 GΩ, thereby making the impedance of the glass sphere relatively low compared to the impedance of the capillary tube.

[0064] As described above, the glass sphere 2 is attached to the capillary glass tube 3 at the joint 14. In a further manufacturing step, two inner tubes 4 and 5 are formed and sized to be inserted into the glass capillary tube 3. In this regard, and as shown in Figure 1, the two inner tubes, or inner tubes 4 and 5, serve to form the remainder of the capillary component. The inner tubes 4 and 5 insulate the sensor probe up to the connection point 14 between the capillary glass tube 3 and the glass sphere 2. The inner tubes 4 and 5 also extend beyond the endpoint 17 of the capillary glass tube 3 to ensure that the signal line 10 does not come into contact with the wall of the capillary glass tube 3.

[0065] The inner tubes 4 and 5 are positioned so that they both extend into the interior of the glass capillary tube 3. Preferably, the inner tubes 4 and 5 extend completely inside the glass capillary tube 3 to the joint 14 where the glass sphere 2 is connected to the glass capillary tube 3.

[0066] The inner tubes 4 and 5 are preferably both made of GRILAMID® polyamide. In this regard, GRILAMID® has the advantages of high flexibility and insulation. Other suitable materials may include polymers / plastics with similar properties, and other materials including metals, ceramics, and carbon materials. While a single inner tube is an option, in this embodiment, a pair of such concentric inner tubes 4 and 5 are provided to enhance the insulation effect.

[0067] Therefore, the inner tubes 4 and 5 are equipped with internal insulating components for the glass capillary tube 3. In this respect, the internal insulating components provide shielding (for example, against RF interference) and strength for the relatively delicate glass capillary tube 3. The internal insulating components further prevent direct contact between the signal line and the capillary tube.

[0068] A binder (for example, an adhesive such as epoxy) is preferably placed between the inner layers of the glass capillary tube 3, such as tubes 4 and 5, to improve overall insulation and fix each component together. During manufacturing, the adhesive is preferably applied inside the glass capillary tube 3, for example, to the opposing surfaces of inner tubes 4 and 5. In this way, air pockets are naturally formed in the adhesive, and such air pockets are preferable as they enhance the overall insulation effect. In connection with this, the inner tubes are not applied directly to the capillary tubes but are connected to the capillary tubes with a binder.

[0069] In this regard, as described above, the binder may be provided between the inner layers 4 and 5 of the glass capillary tube, but such a binder may also be provided between any opposing surfaces of the capillary component or insulating component.

[0070] Furthermore, while the above-mentioned air pockets can be formed within the adhesive between the inner tubes 4 and 5, it will be understood that one or more air / gas pockets or bubbles may be provided within the binder wherever they are provided to enhance the insulating effect.

[0071] Suitable binders may include epoxy, acrylate, cyanoacrylate, silicone, and urethane. One such material may be a cyanoacrylate adhesive.

[0072] In a further preferred embodiment, an epoxy material is used. As shown in Figure 2, during manufacturing, the signal wire 10 in the form of a silver wire 10 is inserted into the inner tubes 4 and 5 until the tip of the silver wire 10 is terminated at the sensor electrode 16 located in the center of the spherical glass sphere 2. In this regard, the electrode 16 may be provided by simply folding a portion of the wire 10 over itself, or a dedicated element may be provided with an arrangement that exhibits an increased surface area in order to increase sensitivity.

[0073] Next, the internal cavities of the glass sphere 2, glass capillary tube 3, and inner tubes 4 and 5 are filled with a technical buffer 12 of a known pH. In a preferred embodiment, the buffer 12 has a pH of 7.0. The inner tubes 4 and 5 are preferably sealed at one end with, for example, an epoxy plug 11, which provides a complete seal around the silver wire 10 to prevent any leakage of the buffer solution 12. The remaining portion of the silver wire 10 extends into the main probe tube 7, where it is welded / soldered to an insulated silver wire that extends along the entire length of the probe tube and terminates with a suitable electrical connector 18 suitable for connection into the monitor 20 shown in Figure 3.

[0074] In this regard, although the inner tubes 4 and 5 are shown to extend outward from the glass capillary tube 3, the ends of the inner tubes may be closer to the end 17 of the glass capillary tube than shown, so that the plug 11 can be used to seal not only the inner tubes 4 and 5 but also the glass capillary tube 3.

[0075] As shown again in Figure 1, the intermediate tube 6 covers the sensor probe 1, signal line 10, and the two internal insulating tubes 4 and 5 from the connection between the glass sphere 2 and the capillary tube 3. The intermediate tube 6 also provides further sealing between the glass capillary tube 3 and the inner tubes 4 and 5, improving the overall strength and rigidity of the sensor probe 1. Furthermore, the intermediate tube 6 provides a high-strength adhesive surface for securely attaching the probe main tube 7 to the sensor probe 1, thereby further preventing the sensor probe 1 from separating from the probe main tube 7.

[0076] While other suitable materials may be used, the intermediate tube 6 is preferably made of GRILAMID®, a lightweight polymer elastomer polyamide. The probe main tube 7 is preferably made from PEBAX®. In a preferred example, the probe main tube 7 extends 1.60 to 1.65 m from the connection point 14 between the glass sphere 2 and the capillary tube 3 and may include the capillary tube 3, tubes 4 and 5, and an intermediate tube 6. The probe main tube 7, and thus the fully covered and insulated wire 10, extends to the monitor 20 shown in Figure 3. The probe main tube may be longer or shorter depending on clinical needs.

[0077] The sensor probe 1 also includes an outer bushing 9 formed and molded or formed or molded around the outer surface of the probe main tube 7. The outer bushing 9 is preferably substantially 1 cm long and supports the connection of the probe main tube 7 to the sensor probe 1. The outer bushing 9 is preferably made of PEBAX®, but other suitable biocompatible materials may be used.

[0078] A cyanoacrylate adhesive (resin) is preferably used to seal the sensor and is also preferably provided between the two inner insulating tubes 4 and 5 to improve overall insulation. The adhesive is also provided between the outside of the two inner tubes and the inside of the glass capillary tube.

[0079] In this regard, a binder such as an adhesive may be provided between one or more layers from the outer bushing 9 to the inner tube 4. In this regard, the adhesive may be provided between all layers from the outer bushing 9 to the inner tube. The adhesive may be epoxy or a suitable alternative.

[0080] The binder is preferably present between all layers, from the innermost to the outermost layer. The binder is preferably inserted between tubular materials by drawing the adhesive in using capillary action. A sterile cotton thread 8 or another suitable part exits the plastic probe tube through a small perforation directly adjacent to the proximal end of the outer bushing 9. pH 7.00 technical buffer 12 is provided inside the glass sphere. This may be, for example, Mettler Toledo 51302047 buffer [pH 7.00].

[0081] The cotton thread 8 is immersed in Friscolyt 13 from within the probe sheath and from the Friscolyt where the probe tip is stored until use. The cotton thread 8 acts as a conductive salt bridge. A reference electrode 23 is provided inside the probe main tube 7.

[0082] As described above and as shown in Figures 1 and 2, the sensor probe 1 has insulation formed of several layers (preferably different plastics), some or all of which are isolated by spaces (e.g., air pockets or bubbles) filled with adhesive resin / fluid or by layers of liquid such as gel applied like an "onion peel". The insulation effect is so effective that after the insulation process is complete, the only detectable impedance reduction region is the glass sphere 2. A further advantage of the arrangement of the internal insulating tube and binder is that chemical interaction or electrical connection is theoretically impossible because the pH 7.0 reference buffer inside the glass sensor sphere is not in contact with the capillary glass.

[0083] In this regard, the internal insulating components include the inner tubes 4 and 5 and any adhesive, air pockets, or other materials provided inside the glass capillary tube 3, while the external insulating components include the intermediate tube 6, the probe main tube 7, and the outer bushing 9, as well as any adhesive, air pockets, or other materials provided between them, which are external components of the glass capillary tube 3.

[0084] Internal and external insulating components, as well as the glass capillary tube, any adhesive, air pockets, or other materials provided between them, contribute to insulating the sensor wire from the environment outside the probe tip.

[0085] By inserting an insulating layer into the capillary tube, another level of insulation is created between the glass sensor and the capillary glass tube, namely insulation between the wiring attached to the glass sensor, the buffer solution, and the inside of the capillary glass tube, thereby maximizing the insulation between the sensor and the capillary glass tube. This is because the capillary glass tube is essentially surrounded or isolated by inner and outer insulating layers of insulating components sealed with epoxy adhesive.

[0086] As described above, the sensor probe 1 includes a memory recording device 21, such as a memory PCB, provided in the connector 18, which stores the details of the full calibration performed on the sensor probe during manufacturing. The full calibration during manufacturing includes the calibration of the sensor probe using at least two buffers to plot the calibration curve or slope of the probe device. In connection with this, the calibration details can be easily accessed and reviewed during use. For example, if the calibration curve is drifting, appropriate adjustments can be made, or if the drift is outside the acceptable range, the sensor probe 1 may be designated as unsuitable for use.

[0087] In connection with this, impedance testing may be performed during factory manufacturing or immediately before use after the probe is fully assembled to verify that the insulation is functioning correctly.

[0088] Figure 3 shows the system of the present invention, including the pH sensor probe 1 as described above, connected to the monitor 20 of the present invention. The monitor 20 is configured to communicate with one or more dedicated pH sensor probes, thereby constructing a pH monitoring system for one or more channels.

[0089] The communication between pH sensor probe 1 and monitor 20 may include the following (in the non-exclusive list below): It transfers pre-configured (factory-set) probe-specific data, including individual probe calibration, unique probe number, manufacturing date, and pre-set storage period, to the monitor.

[0090] Pre-configured calibration data allows the monitor to set parameters that match the probe's specific properties. If the performance falls below the pre-set tolerance standards, probe performance / quality / safety inspections will be performed by immobilizing the probe.

[0091] Drift adjustment (zero adjustment) as needed. A function to immediately disable the probe upon expiration of its storage period. A function to attempt to reuse a probe, which involves immediate immobilization of the probe.

[0092] Probe disconnection alerts (visual and auditory). Probe usage time overrun alerts (visual and auditory). Comprehensive alerts (visual and auditory) for clinically meaningful pH levels.

[0093] Correction of pH probe performance based on drift testing. Monitoring specific alerts: Low battery alert.

[0094] Detection and rejection of pH probes already in use (single-use pH probes). Detection and elimination of pH probes with unacceptable characteristics. Removal alert.

[0095] Disable active mode. The monitor is preferably capable of simultaneously receiving and recording data from up to four probes.

[0096] The probe can be connected and disconnected independently without interfering with the operation of other probes attached to the monitor. The monitor's graphic display may use a "signal" color system to highlight any pH levels of interest to the clinician. This color scheme is used to display the absolute pH value in situ for each probe and the trend of pH over time for each probe.

[0097] inspection Each pH sensor probe 1 and probe component, or each pH sensor probe 1 or probe component, preferably undergoes impedance testing before, during, and after assembly to optimize its performance characteristics and ensure that the quality of the probe's insulation is maintained.

[0098] In connection with this, before fully assembling each probe, the impedance of each glass sphere 2 (connected to the capillary tube) is checked to ensure that the impedance is less than 2 GΩ.

[0099] Before assembly, the impedance of each raw component of the sensor probe 1 is checked. Impedance testing is also performed during and after the assembly of the pH sensor probe 1. Probes that do not meet the impedance requirements are discarded. In this way, the impedance of the glass sphere 2 attached to the glass capillary tube 3 (stem) can be compared with the impedance of the final pH sensor probe 1.

[0100] After the complete assembly of pH sensor probe 1, pH performance tests are repeated at intervals until reading stability is achieved. Performance stability is consistent with the stability of glass bulb 2, which is achieved when the glass bulb is optimally aged.

[0101] After the complete assembly of the pH sensor probe 1, a test can be performed to confirm that the impedance remains within a desirable range, indicating that the insulation of the pH sensor probe 1 continues to function optimally. By combining a satisfactory impedance with an appropriate aging time for the glass sphere 2 used in the manufacture of the pH sensor probe 1, the overall performance of the probe is demonstrated to be maintained. After manufacturing, aging of the glass sensor stabilizes the pH readings, and reading drift becomes negligible. By combining knowledge of the glass sensor's performance after aging with impedance testing to confirm that the glass sensor is still properly insulated, it may be possible to completely eliminate the need for pH drift testing in some situations. Therefore, immediately before use, in some situations, the impedance of the sensor housed within the fully assembled probe can be used (independently) as a functional performance test of the probe.

[0102] Uses of probes The pH sensor probe 1 and system of the present invention may be used to monitor the relative "health" or "condition" of any living tissue (human and other animals) in vivo or ex vivo, or to monitor actually dying or necrotic tissue that is large enough to allow the probe to be inserted, provided that no irreparable injury is caused.

[0103] The pH sensor probe 1 and system can provide real-time information on numerous acute medical problems / diseases, as well as the effects of trauma. Furthermore, the pH sensor probe 1 can enable clinicians to, for example, observe the effects of different treatments, or monitor the progression of viruses such as COVID-19 or their treatments. The pH sensor probe 1 and monitoring system are ultimately expected to be used to assess various organ-specific and general physical conditions.

[0104] In further applications, pH probe devices and systems may be used on necrotic tissue / organs / fluids as forensic tools to determine the time of death, for example. While several embodiments have been described in detail above, other modifications are possible. For example, the exact number and details of the insulating layers can be changed according to requirements.

[0105] Furthermore, although various manufacturing steps have been described, it will be understood that it is not always necessary to perform these manufacturing steps in this exact order or sequence in order to arrive at the same invention or to achieve the desired results. Therefore, other embodiments are within the scope of the following claims.

Claims

1. A probe device for testing the pH of soft tissue, body fluid, or bone, Advanced detection component, A sleeve component for housing a sensor signal line that terminates at one end of the sensor electrode within the aforementioned tip detection component, The insulating component provided on the sleeve component and Equipped with, The insulating component has a layered structure formed of multiple insulating layers, The tip detection component and the sleeve component are connected to each other and contain a common buffer solution. The insulating component includes an internal insulating component provided inside the sleeve component and an external insulating component provided outside the sleeve component. A probe device in which the internal insulating component and the external insulating component extend along the sleeve component from the joint between the sleeve component and the tip detection component.

2. The probe device according to claim 1, wherein the sleeve component takes the form of a capillary component.

3. The probe device according to claim 1, wherein the external insulating component is provided around the sleeve component.

4. a) The insulating layer is formed from different materials, b) The insulating layer is selected from a plastic material, c) The insulating layer is selected from one or more of the following: epoxy material, LDPE, LLDPE co-extruded adhesive resin, or block copolymer. The probe device according to claim 1, comprising one or more of the above.

5. The probe device according to claim 1, wherein a binder is provided in one or more of the insulating layers.

6. The probe device according to claim 5, wherein one or more air pockets are provided in the binder.

7. The probe device according to claim 1, wherein the sleeve component comprises a capillary glass tube in which a pair of concentric inner tubes extend inward.

8. The probe device according to claim 7, wherein the pair of inner tubes are formed from polyamide.

9. The probe device according to claim 7, further comprising: an intermediate tube extending around the capillary glass tube and the inner tube, wherein the inner tube protrudes from the capillary glass tube; a probe main tube extending around the intermediate tube; and an outer bushing extending around the probe main tube.

10. a) The intermediate tube is formed from polyamide, b) The main tube of the probe is formed from polyether block amide, c) The outer bushing is formed from polyether block amide. The probe device according to claim 9, comprising one or more of the above.

11. The probe device according to claim 1, wherein the tip detection component includes a glass sphere made of pH-sensitive glass.

12. a) The impedance of the glass sphere is less than 2 GΩ, b) The impedance ratio between the glass sphere and the sleeve component is within the range of 1:5 to 1:

9. The probe device according to claim 11, comprising one or more of the above.

13. A system for testing the pH of soft tissue, body fluid, or bone, comprising one or more probe devices according to any one of claims 1 to 12, and a monitoring device, wherein the monitoring device communicates with each of the one or more probe devices to provide real-time data relating to the operating parameters of the probe devices and the health status, disease status, or severity of injury of the soft tissue, body fluid, or bone.

14. The system according to claim 13, wherein the monitoring device has a plurality of connection points to each of the probe devices.

15. The system according to claim 14, wherein the monitoring device periodically sends response command signals to each probe device connected to the monitoring device.

16. A method for forming the pH probe device according to Claim 1, The aforementioned sleeve component includes a capillary tube, The tip detection component includes a pH-sensitive glass sphere connected to the capillary tube, The aforementioned method, A method comprising forming the pH-sensitive glass sphere by heating glass to a temperature range of 800 to 1000°C so that it has a viscosity that enables a wall thickness of 0.15 mm to 0.5 mm.

17. A method for forming the pH probe device described in Claim 1, The aforementioned sleeve component includes a capillary tube, The tip detection component includes a glass sphere connected to the capillary tube, The aforementioned method, A method comprising providing multiple insulating material layers in the capillary tube.

18. a) A pair of concentric tubes are formed to extend into the capillary, b) Further comprising an intermediate tube extending around the capillary tube and the inner tube, wherein the inner tube protrudes from the capillary tube, a probe main tube extending around the intermediate tube, and an outer bushing extending around the probe main tube. The method according to claim 17, which includes one of the above.

19. A sensor for measuring the pH of soft tissue, body fluid, or bone in a living organism, A sensor body having a sensor chip formed at one end, and including a spherical glass sphere and a cylindrical glass capillary extending from the glass sphere, the sensor body being formed to have an internal cavity containing a reference buffer, An insulating structure formed around the capillary tube, wherein the insulating structure is One or more inner tubes formed from a first material, the inner tubes being arranged axially within the total length of the capillary tube, and a sensor wire being arranged axially within the one or more inner tubes, the sensor wire having a first end extending into the central portion of the glass sphere and a second end extending beyond the capillary tube, The intermediate tube includes the endpoint of the capillary tube that overlaps with the one or more inner tubes, and covers the capillary tube and the one or more inner tubes. A probe main tube that extends beyond the intermediate tube and covers the intermediate tube, and covers the sensor wire, and An insulating structure including, The outer bushing covering the main tube of the probe of the aforementioned insulating structure A sensor that includes this.

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