Disposable esophageal temperature probe with strip balloon

Abstract

The application discloses a disposable esophageal body temperature probe with a strip-shaped air bag, which comprises a flexible lead wire, a body temperature detection end, a strip-shaped air bag and a gas charging and discharging unit. The body temperature detection end is arranged at the front end of the flexible lead wire and is internally provided with a thermal sensor. The strip-shaped air bag is sleeved outside the flexible lead wire and extends along the length direction of the flexible lead wire, and the length is configured to cover at least the anatomical section from the oral cavity to the throat of a corresponding patient. The gas charging and discharging unit is connected with the strip-shaped air bag and is used for charging or discharging gas into the strip-shaped air bag. The strip-shaped air bag is inflated by the gas charging unit, so that the strip-shaped air bag is expanded and generates radial constraint and axial support on the flexible lead wire, so that at least the section of the probe from the oral cavity to the throat is transformed from a first flexible state into a second rigid state suitable for passing through the curved anatomical structure of the oral pharynx. The gas in the strip-shaped air bag is discharged by the gas discharging unit, so that the strip-shaped air bag is contracted, so that the probe is restored from the second rigid state to the first flexible state and is left. The application provides an esophageal body temperature probe placement auxiliary scheme which is simple in structure, convenient to operate, can effectively provide temporary rigid support and can restore flexibility after placement, can improve the placement success rate and improve the clinical safety.

Description

Technical Field

[0001] This invention relates to an esophageal temperature probe, and more particularly to a disposable esophageal temperature probe with a strip-shaped air bladder. Background Technology

[0002] Esophageal temperature monitoring is a commonly used method for monitoring body temperature in clinical anesthesia, intensive care, and cardiac surgery. Its measurement location is close to the heart and aorta, allowing for relatively accurate reflection of changes in core body temperature. Currently, most clinically used esophageal temperature probes employ a flexible wire structure with a thermal sensor at the tip, inserted through the mouth to the target location in the esophagus for continuous monitoring.

[0003] In existing technologies, disposable flexible esophageal temperature probes typically consist of a flexible lead wire and a front-end temperature sensing tip. This flexible lead wire possesses good flexibility, allowing it to conform to the natural curves of the esophagus and reduce irritation to the mucosa. For example, a Chinese utility model patent discloses an auscultatory esophageal temperature probe, the main body of which is made of flexible material for easy insertion; a US patent discloses an esophageal probe with an inflatable balloon, the balloon primarily used for auxiliary positioning or acoustic transmission; and some other catheter-related products (such as endotracheal tubes or gastric tubes) employ a localized balloon structure for fixation or sealing.

[0004] However, the flexible esophageal temperature probes in the aforementioned existing technologies have the following drawbacks during actual clinical placement: Because the probe body is generally flexible, it is easily subjected to pressure or friction from soft tissues such as the base of the tongue, epiglottis, and posterior pharyngeal wall when passing through curved anatomical structures such as the oral cavity and pharynx, resulting in lateral bending, twisting, or rolling. This makes it difficult for the probe tip to accurately and smoothly enter the esophageal inlet, increasing the placement failure rate, operation time, and patient discomfort, and may even cause mucosal damage or accidental airway entry. Existing auxiliary insertion methods mostly rely on additional guidewires, rigid sheaths, or operator adjustments, but these methods either increase the complexity of the instruments, make it difficult to achieve single-use, or cannot effectively solve the problem of local lateral instability within the oral cavity.

[0005] Therefore, there is currently a lack of an esophageal temperature probe placement assistance scheme that is simple in structure, easy to operate, can effectively provide temporary rigid support, and can restore flexibility after placement, so as to improve the success rate of placement and enhance clinical safety. Summary of the Invention

[0006] To address the technical problems of existing flexible esophageal temperature probes being prone to lateral bending, twisting, or rolling when passing through the curved anatomical structures from the oral cavity to the pharynx, resulting in difficult insertion, high failure rate, prolonged operation time, and increased patient discomfort, this invention provides a method for assisting in the insertion of a disposable soft esophageal temperature probe, a disposable esophageal temperature probe with a strip-shaped airbag, and an esophageal temperature monitoring system.

[0007] One of the technical solutions of the present invention is a method for assisted insertion of a disposable soft esophageal temperature probe, comprising the following steps: An esophageal temperature probe is provided, the probe including a flexible wire and a temperature detection end disposed at its front end, and a strip-shaped airbag extending along its length is sleeved on the outside of the flexible wire. Gas is inflated into the strip-shaped airbag through the inflation unit, causing the airbag to expand and provide radial constraint and axial support to the flexible wire. This transforms at least the corresponding oral cavity to pharyngeal segment of the probe from a first flexible state to a second rigid state suitable for traversing the curved anatomical structure of the oropharynx. In the inflated state, the strip-shaped airbag has a symmetrical cross-section to provide directional radial support force to resist lateral bending or curling of the flexible wire within the oral cavity. In the second rigid state, the probe is placed into the target temperature measurement position in the patient's esophagus; the gas in the strip-shaped airbag is released through the degassing unit, causing the strip-shaped airbag to contract, thereby restoring the probe from the second rigid state to the first flexible state and leaving it in place.

[0008] Furthermore, during the process of inflating the strip-shaped airbag, the pressure inside the strip-shaped airbag can be monitored in real time; when the pressure reaches a preset threshold pressure range (e.g., 20 mmHg to 60 mmHg), inflation is stopped to avoid over-inflation leading to tissue damage or airbag rupture.

[0009] The second technical solution of the present invention is a disposable esophageal temperature probe with a strip-shaped airbag, comprising a flexible lead wire, a temperature detection end, a strip-shaped airbag, and an inflation / deflation unit. The temperature detection end is disposed at the front end of the flexible lead wire and contains a thermal sensor; the strip-shaped airbag is sleeved on the outside of the flexible lead wire and extends along the length of the flexible lead wire, the length of which is configured to at least cover the anatomical segment from the patient's mouth to the pharynx; the inflation / deflation unit is connected to the strip-shaped airbag and is used to inflate or release gas into the strip-shaped airbag.

[0010] The strip-shaped airbag is configured to: inflate in an inflated state, simultaneously applying radial constraint and axial support to the flexible conductor, causing the flexible conductor to change from a first flexible state to a second rigid state at least corresponding to the oral cavity to pharynx region; and contract in a deflated state, causing the flexible conductor to return from the second rigid state to the first flexible state.

[0011] In the inflated state, the strip-shaped airbag has a symmetrical cross-section to provide directional radial support force to resist lateral bending or curling of the flexible wire in the oral cavity.

[0012] Furthermore, the strip-shaped airbag adopts an integrated extended structure with airbag segments arranged axially along the flexible guide wire. The proximal airbag segment near the operator's hand or the connection point of the inflation / deflation unit has a larger maximum diameter when inflated than the distal airbag segment near the body temperature detection end. This better adapts to the gradual anatomical transition from the oral cavity to the pharynx, improving the targeted support and safety.

[0013] The inflation / deflation unit may include an inflatable bladder, a deflation valve, a connecting pipe, and a pressure feedback mechanism. The pressure feedback mechanism is used to indicate or limit the pressure inside the strip-shaped bladder, for example, through a visual pressure gauge, a safety pressure relief valve, or the tactile hardness of the inflatable bladder itself, provided on the connecting pipe.

[0014] The outer surface of the flexible conductor and / or the inner surface of the strip-shaped airbag may be provided with mutually cooperating anti-slip limiting structures, such as concave-convex interlocking structures and / or high friction coefficient material layers, to prevent the strip-shaped airbag from axially slipping relative to the flexible conductor during inflation and deflation.

[0015] The third technical solution of the present invention is an esophageal temperature monitoring system, including the aforementioned disposable esophageal temperature probe with a strip-shaped air bladder and a temperature monitor. The temperature monitor is electrically connected to the thermistor and is used to receive and display temperature signals.

[0016] Furthermore, it may also include a control module, which is communicatively connected to the inflation / deflation unit and configured to control the inflation, deflation, and pressure maintenance of the strip-shaped airbag based on a preset program or instructions from the user; the control module may include a microcontroller or an application-specific integrated circuit.

[0017] By adopting the above technical solution, the present invention can provide sufficient axial support and directional radial bending resistance through temporary inflation of the strip-shaped airbag during the insertion process, so that the flexible probe can pass smoothly through the curved parts of the oral cavity and pharynx; after the insertion is completed, the air is deflated to restore the flexible state, reducing long-term pressure on the esophageal mucosa; at the same time, the safety and accuracy of the operation are further improved through pressure monitoring and segmented / asymmetric design. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the structure of the present invention; In the diagram: 1. Temperature detection end; 2. Flexible wire; 3. Strip-shaped airbag; 4. Inflation tube; 5. Valve; 6. Two-way connector; 7. Scale line. Detailed Implementation

[0019] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention. Example

[0020] like Figure 1 As shown in this embodiment, a disposable esophageal temperature probe with a strip-shaped airbag is provided, comprising a flexible lead wire, a temperature detection end, a strip-shaped airbag, and an inflation / deflation unit. The flexible lead wire is made of medical-grade polyvinyl chloride (PVC) or polyurethane (PU) material, possessing good flexibility and biocompatibility. The temperature detection end is located at the distal end of the flexible lead wire, internally encapsulating an NTC thermistor (accuracy ±0.1℃) as a thermal sensor. The sensor lead wire runs along the inside of the flexible lead wire to the proximal end, connecting to a temperature monitor. The strip-shaped airbag is fitted onto the outer surface of the flexible lead wire and extends along its length, with an axial length of approximately 200-250mm (designed to cover the anatomical segment from the patient's oral cavity to the pharynx, typically from the posterior margin of the dentition to the level of the cricoid cartilage). The airbag material is medical-grade silicone or low-hardness polyurethane, with a wall thickness of 0.1-0.3mm. The airbag is connected to the inflation / deflation unit through small inflation tubes on one or both sides. In its uninflated state, the strip-shaped airbag is flat or wrinkled, conforming to the flexible wire (first flexible state). Upon inflation, it expands, providing radial constraint and axial support to the flexible wire, transforming the corresponding section into a second rigid state. In the inflated state, the strip-shaped airbag has a symmetrical support structure, such as a U-shaped cross-section. This symmetrical design provides directional radial support force, primarily resisting lateral bending or curling of the probe caused by pressure from soft tissues such as the tongue root and epiglottis within the oral cavity. The inflation / deflation unit includes a hand-operated inflatable airbag, a deflation valve, connecting tubing, and a pressure feedback mechanism. In this embodiment, the pressure feedback mechanism is a visual pressure gauge installed on the connecting tubing, or a safety pressure relief valve (set to open at 60 mmHg). During operation, air is injected into the strip-shaped airbag by squeezing the inflatable airbag, and the pressure gauge is observed in real time. Inflation stops when the pressure reaches 30-50 mmHg. After insertion, the deflation valve is pulled to release the gas, and the strip-shaped airbag contracts and regains its flexibility.

[0021] Usage procedure: First, insert the probe into the throat through the mouth without inflation; then inflate it to expand the strip-shaped air bladder, providing temporary rigid support to facilitate further advancement to the target position in the esophagus (usually 25-35cm from the incisors); after reaching the target position, deflate it and leave the probe in place for continuous body temperature monitoring. Example

[0022] In this embodiment, the strip-shaped airbag adopts an integrated extended structure. The maximum diameter of the proximal airbag segment after inflation is approximately 12-18 mm; the maximum diameter of the distal airbag segment after inflation is approximately 8-12 mm. This gradual diameter design adapts to the anatomical characteristics of the oral cavity to pharynx region: the oral cavity entrance is wider and gradually narrows towards the pharynx, thereby providing a more snug fit and reducing the risk of local pressure. Example

[0023] In this embodiment, to prevent the strip-shaped airbag from axially slipping relative to the flexible wire during inflation and deflation, an annular groove is provided on the outer surface of the flexible wire, and corresponding raised ribs are provided on the inner surface of the strip-shaped airbag, forming an anti-slip limiting structure with interlocking concave and convex shapes. Alternatively, a high-friction coefficient silicone layer is coated on the surface of the flexible wire and the inner surface of the airbag. This structure enhances friction during inflation, ensuring the stability of the airbag position; and does not affect the flexibility of the probe after deflation.

Claims

1. A disposable esophageal temperature probe with a strip-shaped airbag, characterized in that, Includes: flexible conductors; A body temperature detection end is disposed at the front end of the flexible lead wire, and a thermal sensor is disposed therein; a strip-shaped airbag is sleeved on the outside of the flexible lead wire and extends along the length of the flexible lead wire, the length of which is configured to at least cover the anatomical segment from the patient's mouth to the pharynx; an inflation / deflation unit is connected to the strip-shaped airbag and is used to inflate or release gas into the strip-shaped airbag; wherein, the strip-shaped airbag is configured to: inflate in the inflated state, simultaneously apply radial constraint and axial support to the flexible lead wire, so that the flexible lead wire at least corresponding to the mouth to pharynx segment changes from a first flexible state to a second rigid state; and in deflate in the deflated state, so that the flexible lead wire returns from the second rigid state to the first flexible state; wherein, in the inflated state, the cross-section of the strip-shaped airbag has a symmetrical support structure to provide directional radial support force to resist lateral bending or curling of the flexible lead wire in the oral cavity.

2. The disposable esophageal temperature probe according to claim 1, characterized in that, The strip-shaped airbag is an integrally extended structure, consisting of airbag segments arranged axially along the flexible conductor.

3. The disposable esophageal temperature probe according to claim 2, characterized in that, The maximum diameter of the proximal capsule segment near the operator's handheld end or the connection end of the inflation / deflation unit in the inflated state is greater than the maximum diameter of the distal capsule segment near the body temperature detection end in the inflated state.

4. A method for assisted insertion of a disposable soft esophageal temperature probe, characterized in that, Includes the following steps: An esophageal temperature probe is provided, the probe including a flexible wire and a temperature detection end disposed at its front end, and a strip-shaped airbag extending along its length is sleeved on the outside of the flexible wire. Gas is inflated into the strip-shaped balloon via the inflation unit, causing the balloon to expand and provide radial constraint and axial support to the flexible wire. This transforms at least the corresponding oral cavity to pharyngeal segment of the probe from a first flexible state to a second rigid state suitable for traversing the curved anatomical structures of the oropharynx. In the inflated state, the strip-shaped balloon has an asymmetrical cross-section to provide directional radial support against lateral bending or coiling of the flexible wire within the oral cavity. In the second rigid state, the probe is placed at the target temperature measurement location within the patient's esophagus. Gas is released from the strip-shaped balloon via the deflation unit, causing the balloon to contract and restoring the probe from the second rigid state to the first flexible state, where it remains in place.

5. The method according to claim 4, characterized in that, During the inflation of the strip-shaped airbag, the pressure inside the strip-shaped airbag is monitored in real time; when the pressure reaches a preset threshold pressure range, inflation is stopped; the preset threshold pressure range is 20 mmHg to 60 mmHg.

6. The disposable esophageal temperature probe according to any one of claims 1-3, characterized in that, The inflation / deflation unit includes an inflation bladder, a deflation valve, a connecting pipe, and a pressure feedback mechanism; the pressure feedback mechanism is used to indicate or limit the pressure inside the strip-shaped air bladder; the pressure feedback mechanism is a visual pressure gauge, a safety pressure relief valve, or the tactile hardness of the inflation bladder itself, located on the connecting pipe.

7. The disposable esophageal temperature probe according to claim 1, characterized in that, The outer surface of the flexible conductor and / or the inner surface of the strip-shaped airbag are provided with mutually cooperating anti-slip limiting structures, the anti-slip limiting structures including concave-convex interlocking structures and / or a high friction coefficient material layer.

8. The disposable esophageal temperature probe according to any one of claims 1 to 3, characterized in that, The strip-shaped airbag is made of medical-grade silicone or polyurethane; and / or the rigidity of the strip-shaped airbag in the inflated state is configured to allow the flexible wire to pass through the curved structure of the oropharynx without damaging the esophageal mucosa.

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