Protecting and fixing device for continuous dynamic blood glucose sensor

Abstract

The utility model relates to a protecting and fixing device for a continuous dynamic blood glucose sensor. The protecting and fixing device comprises a box body with an opening in the lower end and a pair of closed-loop type fixing devices. The box body is of a three-layer structure, the inner layer is a silica gel layer, the middle layer is a metal lead thin plate layer, the outer layer is a hard protection layer, and the metal lead thin plate layer is completely covered with the inner layer and the outer layer and tightly wrapped with the inner layer and the outer layer; the closed-loop fixator extends from the inner layer to two sides and is connected with the inner layer; and the box body can cover the continuous dynamic blood glucose sensor. According to the utility model, a patient wearing the CGM does not need to pull out the sensor during treatment periods such as CT (Computed Tomography) examination, X-ray, radiotherapy or surgical electric cauterization, and meanwhile, the sensor is protected from the problems that the accuracy is reduced, the service life of equipment is shortened and the like due to the influence of imaging examination environments such as radiation and the like; the patient is prevented from repeatedly placing the sensor to increase the cost benefit of the patient, and finally the continuous blood glucose monitoring of the patient is facilitated.

Description

Technical Field

[0001] The utility model relates to a protector and a fixer for a continuous dynamic blood sugar sensor, belonging to the technical field of medical equipment. Background Art

[0002] When patients who are undergoing continuous glucose monitoring (CGM) are undergoing CT scans, X-ray examinations, radiotherapy, or surgical electrocautery, the device can be worn on top of the CGM sensor to protect and secure the sensor, preventing the glucose sensor and analysis software inside the CGM sensor from being affected by factors such as radiation and pressure, which could reduce its lifespan or reduce the accuracy of blood glucose measurements. It also serves to secure the CGM and prevent it from being rubbed, squeezed, or scratched during the examination, causing it to fall off unintentionally.

[0003] Blood sugar management is an important measure to improve the prognosis of diabetic patients, and glucose concentration monitoring is the first step in blood sugar management for patients. Its results are an important basis for blood sugar intervention and treatment effect evaluation. With the development of blood sugar technology, continuous glucose monitoring (CGM) has gradually come out. It refers to the technology of continuously measuring the glucose concentration in the interstitial fluid of subcutaneous tissues through a glucose sensor. It can reflect the continuous and comprehensive blood sugar fluctuation trends and characteristics, and discover hidden hyperglycemia and hypoglycemia that are not easily detected by traditional monitoring methods, which can bring benefits to the clinical blood sugar management of diabetic patients.

[0004] CGM devices usually include a portable host, a probe assembly mounted on the host, and a matching mobile terminal. The CGM glucose sensor, which consists of a host and a probe assembly, is a minimally invasive wearable device. As a key part of CGM technology, it usually contains a chip and a fine hose connecting the instrument and the probe head. The probe head can be inserted into the subcutaneous tissue to receive the electrical signal generated by the oxidation reaction of glucose in the interstitial fluid, thereby indirectly reflecting the blood glucose concentration in the interstitial fluid.

[0005] The sensor usually needs to be fixed on the upper arm or abdomen and can be used continuously for 14 days. However, improper operation during use, such as pressure, exposure to radiation, high-intensity exercise at the implant site, etc., will affect the accuracy of the CGM device, reduce the life of the device, cause safety hazards and reduce cost-effectiveness. The instructions for common brands of "dynamic glucose meters" and the Chinese clinical guidelines for continuous dynamic glucose both mention the precautions for wearing and use, including that the continuous glucose monitoring system must be removed before magnetic resonance imaging (MRI) to avoid exposing the CGM sensor to any strong magnetic field and imaging examination environment, such as magnetic resonance imaging (MRI), conventional X-ray imaging and computed tomography (CT). The hospital consensus guidelines on continuous glucose monitors and automatic insulin delivery systems point out that no CGM components should be worn during MRI or diathermy treatment, and the sensor can be retained during CT scans, but the CGM sensor must be kept outside the CT scanning area and covered with a lead shield during the scan.

[0006] With the gradual strengthening of CMG product market promotion and the continuous improvement of patient acceptance, it is expected that the penetration rate of CGM in patients with type 1 diabetes will increase from 5% in 2019 to 30% in 2030, and the penetration rate of CGM in patients with type 2 diabetes who require intensive insulin treatment will increase from 0.5% in 2019 to 15% in 2030. This indicates that more and more diabetic patients will use CGM for blood sugar management in the future. The application scope of CGM has also gradually penetrated from early outpatient patients to inpatient patients. At present, many hospitals at home and abroad have applied continuous dynamic blood glucose monitoring in endocrinology departments, intensive care units and other wards. More and more inpatient diabetic patients use CGM for in-hospital blood sugar management, which will be a future development trend. However, with the increase in the penetration rate of CGM in inpatients, in-hospital patients will inevitably need to be exposed to strong magnetic fields and imaging examination environments while wearing CGM, such as routine CT examinations, X-rays, regular radiotherapy and various surgical electrocautery operations. At present, the measures usually taken by hospitals for such situations are to remove the CGM sensor, which not only affects the patient's blood sugar management, causing continuous blood sugar monitoring failure and subjecting the patient to multiple puncture operations, but also brings additional economic burden to the patient and causes adverse effects on the patient's body and mind. Another treatment measure is to use conventional lead clothing, lead caps, lead plates and other equipment to shield the CGM, but this type of conventional lead shielding cover has the problems of being too large and not portable, too heavy and easy to compress the sensor and affect the accuracy, and different shapes that do not match the miniature CGM sensor and easily cause sensor peeling, which brings a lot of inconvenience to patients and hospital diagnosis and treatment. At present, there is a lack of a lead shielding cover that can protect and fix the CGM sensor during CT examinations, X-rays, radiotherapy or surgical electrocautery, and has the advantages of being portable, simple, able to avoid local sensor pressure, and matching sensor shapes. Summary of the invention

[0007] The technical problem that the utility model needs to solve is that more and more patients use CGM for continuous dynamic blood glucose management. During the period of wearing CGM, patients will inevitably encounter the need to undergo CT examinations, X-ray examinations, regular radiotherapy and various surgical electrocautery operations, especially hospitalized patients. The utility model aims to provide a CGM sensor protector and fixator, the purpose of which is to prevent the sensor from being removed when patients wearing CGM need to undergo these examinations, and to protect the CGM sensor from being interfered by radiation and imaging examination environments that affect the accuracy and life expectancy of the sensor, so as to help patients smoothly monitor continuous blood glucose and improve the cost-effectiveness of CGM equipment.

[0008] The utility model adopts the following technical solutions:

[0009] A protector and holder for a continuous dynamic blood glucose sensor, comprising a box body with an open lower end and a pair of closed-loop holders; the box body is made of a three-layer structure, with an inner layer being a silicone layer, a middle layer being a metal lead sheet layer, and an outer layer being a hard protective layer, wherein the inner and outer layers completely cover the metal lead sheet layer and tightly wrap it therein; the closed-loop holders extend from the inner layer to both sides and are connected; the box body can cover the continuous dynamic blood glucose sensor.

[0010] Preferably, the silicone layer extends outward and is connected to a sleeve ring structure 4, and the sleeve ring structure 4 is connected to the closed-loop fixer.

[0011] Furthermore, the closed-loop fastener is divided into two types: the first closed-loop fastener 1 has a loop surface 11 of a buckle at one end and a matching hook surface 12 of a buckle at the other end; the second closed-loop fastener 3 is a nylon buckle, with a sub-buckle 31 at one end and a female buckle 32 at the other end.

[0012] Furthermore, the box body has a rectangular structure, and its internal space is slightly larger than the continuous dynamic blood glucose sensor.

[0013] Preferably, the hard protective layer 23 is made of hard plastic.

[0014] Preferably, the closed-loop fixator is an arm ring type fixator or an abdominal ring type fixator.

[0015] The beneficial effects of the utility model are:

[0016] 1) The protection and fixation device of the continuous dynamic blood glucose sensor can help patients wearing CGM to avoid removing the sensor during treatments such as CT examinations, X-rays, radiotherapy or surgical electrocautery, while protecting the sensor from the influence of imaging examination environments such as radiation, which may cause problems such as reduced accuracy and shortened device life, thereby avoiding the need for patients to repeatedly insert sensors and increase patient cost-effectiveness, and ultimately helping patients achieve continuous blood glucose monitoring.

[0017] 2) The device has the advantages of being portable, easy to operate, and matching the shape of the sensor. It is not only convenient for patients and medical staff to use, but also can prevent the sensor from being pressed or scratched during the examination, causing unplanned shedding of the sensor. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 It is a schematic diagram of the appearance of the protector and fixer of the continuous dynamic blood glucose sensor of the utility model in the first embodiment.

[0019] Figure 2 It is a cross-sectional schematic diagram of a box body with an open lower end.

[0020] Figure 3 It is a schematic diagram of the appearance of the protector and fixer of the continuous dynamic blood glucose sensor of the utility model in the second embodiment.

[0021] Figure 4 It is a schematic diagram of a pair of ring structures extending outward from the inner structure of a box body with an open lower end.

[0022] In the figure, 1. the first type of closed-loop fastener, 2. the box body, 3. the second type of closed-loop fastener, 4. the ring structure, 11. the ring surface, 12. the hook surface, 31. the child buckle, 32. the mother buckle, 21. one side of the box body, 22. the metal thin lead plate layer, 23. the hard protective layer. DETAILED DESCRIPTION

[0023] The utility model is further described below in conjunction with the accompanying drawings and specific embodiments.

[0024] Embodiment 1:

[0025] See also Figure 1-2 A protector and fixer for a continuous dynamic blood glucose sensor, comprising a box body with an open lower end and a pair of closed-loop fixers; the material of the box body has a three-layer structure, the inner layer is a silicone layer, the middle layer is a metal lead sheet layer, and the outer layer is a hard protective layer, the inner layer and the outer layer completely cover the metal lead sheet layer and tightly wrap it therein; the closed-loop fixer extends from the inner layer to both sides and is connected; the box body can cover the continuous dynamic blood glucose sensor.

[0026] See also Figure 4The silicone layer extends outward and is connected to a sleeve ring structure 4, and the sleeve ring structure 4 is connected to the closed-loop fixer.

[0027] See also Figure 2 and Figure 4 The box body is a rectangular structure, and its internal space is slightly larger than the continuous dynamic blood glucose sensor. The continuous dynamic blood glucose sensor is not drawn in the attached drawings.

[0028] In this embodiment, see Figure 2 The hard protective layer 23 is made of hard plastic.

[0029] In this embodiment, the closed-loop fixator is an arm ring type fixator or an abdominal ring type fixator. The difference between the two is that the lengths of the closed-loop fixators are different, and the drawings do not show this specific distinction.

[0030] See also Figure 1 In this embodiment, the closed-loop fastener is a first type of closed-loop fastener 1 having a loop surface 11 of a buckle at one end and a matching hook surface 12 of a buckle at the other end.

[0031] Before patients wearing continuous glucose monitors (CGM) undergo CT scans, X-rays, radiotherapy, or surgical electrocautery, they should select an arm or abdominal strap according to the patient's sensor insertion site, connect the strap to the lead sheet protection to form a complete sensor protection and holder, and cover the device above the CGM sensor, close to the skin on all sides to avoid pressure and contact with the sensor. After the patient's examination, unfasten the strap, wipe the lead sheet protector with alcohol cotton balls or disinfectant wipes, and place it in a dry, cool, room temperature place to dry naturally for later use.

[0032] Embodiment 2:

[0033] See also Figure 1-2 A protector and fixer for a continuous dynamic blood glucose sensor, comprising a box body with an open lower end and a pair of closed-loop fixers; the material of the box body has a three-layer structure, the inner layer is a silicone layer, the middle layer is a metal lead sheet layer, and the outer layer is a hard protective layer, the inner layer and the outer layer completely cover the metal lead sheet layer and tightly wrap it therein; the closed-loop fixer extends from the inner layer to both sides and is connected; the box body can cover the continuous dynamic blood glucose sensor.

[0034] See also Figure 4 The silicone layer extends outward and is connected to a sleeve ring structure 4, and the sleeve ring structure 4 is connected to the closed-loop fixer.

[0035] See also Figure 2 and Figure 4 The box body is a rectangular structure, and its internal space is slightly larger than the continuous dynamic blood glucose sensor. The continuous dynamic blood glucose sensor is not drawn in the attached drawings.

[0036] In this embodiment, see Figure 2 The hard protective layer 23 is made of hard plastic.

[0037] In this embodiment, the closed-loop fixator is an arm ring type fixator or an abdominal ring type fixator. The difference between the two is that the lengths of the closed-loop fixators are different, and the drawings do not show this specific distinction.

[0038] The difference between this embodiment and the first embodiment is: Figure 3 The closed-loop fastener is a second closed-loop fastener 3, one end of which is a sub-buckle 31 and the other end of which is a female buckle 32.

[0039] Before patients wearing continuous glucose monitors (CGM) undergo CT scans, X-rays, radiotherapy, or surgical electrocautery, they should select an arm or abdominal strap according to the patient's sensor insertion site, connect the strap to the lead sheet protection to form a complete sensor protection and holder, and cover the device above the CGM sensor, close to the skin on all sides to avoid pressure and contact with the sensor. After the patient's examination, unfasten the strap, wipe the lead sheet protector with alcohol cotton balls or disinfectant wipes, and place it in a dry, cool, room temperature place to dry naturally for later use.

[0040] The above two embodiments are both optional embodiments of the present invention. Ordinary technicians in this field can also make respective changes or improvements on this basis. Without departing from the overall concept of the present invention, these changes or improvements should fall within the scope of protection required by the present invention.

Claims

1. A protector and holder for a continuous dynamic blood glucose sensor, characterized in that: It includes a box body with an open lower end and a pair of closed-loop fasteners; The material of the box body has a three-layer structure, the inner layer is a silicone layer, the middle layer is a metal lead sheet layer (22), and the outer layer is a hard protective layer (23), and the inner layer and the outer layer completely cover the metal lead sheet layer (22) and tightly wrap it therein; The closed-loop fastener extends from the inner layer to both sides and is connected; The box body can cover the continuous dynamic blood glucose sensor.

2. The protector and holder for the continuous dynamic blood glucose sensor according to claim 1, characterized in that: The silicone layer extends outward and is connected to a sleeve ring structure (4), and the sleeve ring structure (4) is connected to the closed-loop fixer.

3. The protector and holder for the continuous dynamic blood glucose sensor according to claim 2, characterized in that: The closed-loop fasteners are divided into two types: the first type of closed-loop fastener (1) has a loop surface (11) of a buckle at one end and a matching hook surface (12) of a buckle at the other end; the second type of closed-loop fastener (3) is a nylon buckle, with a sub-buckle (31) at one end and a female buckle (32) at the other end.

4. The protector and holder for the continuous dynamic blood glucose sensor according to claim 1 or 2, characterized in that: The box body is in a rectangular structure, and its internal space is slightly larger than the continuous dynamic blood glucose sensor.

5. The protector and holder for the continuous dynamic blood glucose sensor according to claim 1, characterized in that: The hard protective layer (23) is made of hard plastic material.

6. The protector and holder for the continuous dynamic blood glucose sensor according to claim 1, characterized in that: The closed-loop fixator is an arm ring type fixator or an abdominal ring type fixator.

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