Arm fixing device for hemodialysis in nephrology department and blood leakage prevention method

By designing an arm fixation device for hemodialysis in the nephrology department, using a transparent elastic membrane and a self-sealing interface, and dynamically adjusting the pressure, the problem of blood leakage during hemodialysis was solved, thus improving the safety and stability of dialysis.

CN120983234APending Publication Date: 2025-11-21THE FIRST AFFILIATED HOSPITAL OF ARMY MEDICAL UNIV
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Patent Information

Application Number
CN202511314820.2
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-09-15
Publication Date
2025-11-21

AI Technical Summary

Technical Problem

During hemodialysis, the patient's hand movements may cause gaps to appear between the blood vessels and the skin at the puncture site, leading to bleeding. Current technology lacks effective fixation and protection measures, posing a safety hazard.

Method used

A fixation device for hemodialysis arms in nephrology has been designed, including a needle holder, a fixation strap, and a locking buckle. Combined with a transparent elastic membrane and a self-sealing interface, the device dynamically adjusts the pressure to control blood leakage by monitoring the level of blood leakage and the conductivity strength.

Benefits of technology

It effectively prevents blood leakage caused by hand movements during dialysis, improves treatment safety and stability, ensures stable fixation of the dialysis needle, and reduces the risk of infection for patients.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention provides an arm fixing device for hemodialysis in the nephrology department and a blood leakage prevention method, belongs to the technical field of medical instruments, and aims to solve the technical problem that blood leakage is likely to occur in the hemodialysis treatment process in the prior art. Comprising a needle frame, a fixing band and a locking fastener, the needle frame comprises a seat body and a cover body which are buckled, the seat body is provided with a vertically-penetrating needle head cavity and a needle body cavity laterally penetrating into the needle head cavity, the needle body cavity is provided with a needle handle fixing structure, a cover body cavity is formed in the position, corresponding to the needle head cavity, of the cover body, a transparent plate is arranged on the outer side of the cover body cavity, and a transparent elastic film is arranged on the inner side of the cover body cavity. The cover body is provided with a self-sealing interface which is communicated with the transparent plate and the elastic film interlayer; the two fixing belts are fixedly connected to the two sides of the base body respectively, and the lock catch piece is fixedly connected with the outer ends of the two fixing belts. And a gap at an acupuncture position caused by hand movement during dialysis is effectively prevented, the risk of blood leakage is greatly reduced, and the treatment safety is guaranteed.
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Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a hand fixing device for hemodialysis in nephrology and a blood leakage prevention method. BACKGROUND

[0002] In the clinical treatment of nephrology, hemodialysis is an important alternative treatment for patients with renal failure. During treatment, the patient's blood is drawn out of the body, the material exchange is completed through the dialyzer, the metabolic waste and excess water are removed, and then the blood is returned to the body to maintain normal physiological functions.

[0003] However, there are certain risks in this treatment process. The dialysis time is relatively long, and the patient's hand movement during dialysis may pull the puncture site and the catheter, causing a gap between the needle and the skin, and further causing blood leakage.

[0004] In order to ensure the safety of hemodialysis treatment and reduce the risk of blood leakage in patients, the existing fixed protection measures during dialysis need to be optimized and improved. SUMMARY

[0005] In view of the deficiencies of the prior art, the present application provides a hand fixing device for hemodialysis in nephrology and a blood leakage prevention method to solve the technical problem of blood leakage during hemodialysis treatment in the prior art.

[0006] The technical scheme adopted by the present application is that the hand fixing device for hemodialysis in nephrology comprises a needle holder, a fixing belt and a lock piece. The needle holder comprises a clamped seat body and a cover body, the seat body is provided with a vertical needle cavity and a needle body cavity laterally penetrating the needle cavity, the needle body cavity is provided with a needle handle fixing structure, the cover body is provided with a cover cavity corresponding to the needle cavity, a transparent plate is provided outside the cover cavity, and a transparent elastic membrane is provided inside the cover cavity, a self-sealing interface is provided on the cover body and communicates with the transparent plate and the elastic membrane. Two fixing belts are respectively fixedly connected to the two sides of the seat body, and the lock piece is fixedly connected to the outer ends of the two fixing belts.

[0007] Optionally, a pressing protrusion is arranged on the cover body corresponding to the needle body cavity, and the pressing protrusion is made of elastic material.

[0008] Optionally, the needle handle fixing structure comprises a needle handle seat and a fixing nut.

[0009] Optionally, at least one air bag membrane is arranged on each side of the fixing belt, and the air volume in each air bag membrane can be adjusted.

[0010] Optionally, the air bag membrane is also connected to the outside through a self-sealing interface.

[0011] Optionally, the end of the seat body is provided with a connecting rod, the connecting rod is hollow, and the two sides of the fixing belt are respectively rotationally connected with the connecting rods on the two sides of the seat body, and the hollow areas of the connecting rods on the two sides are respectively communicated with the air bag membranes of the fixing belts on the two sides; The connecting end of the connecting rod and the seat body is provided with an air volume adjusting structure.

[0012] Optionally, the air volume adjusting structure comprises a containing cavity, a sliding plate, an adjusting nut and an elastic piece; The containing cavity is communicated with the inside of the connecting rod, the sliding plate is slidingly arranged in the containing cavity, the elastic piece is arranged between the containing cavity and the sliding plate, and the adjusting nut is threadedly connected with the cover body and abuts against the sliding plate.

[0013] Optionally, the bottom side of the needle cavity is provided with a blood leakage detection membrane, the middle part of the blood leakage detection membrane is provided with a hole for the needle to pass through, and a plurality of conductive rings are arranged in the hole in a concentric and spaced manner.

[0014] Optionally, the transparent plate is a convex lens; and / or the self-sealing interface is a rubber nozzle, the needle can be inserted to communicate, and the needle hole is automatically blocked after the needle is pulled out.

[0015] Optionally, the transparent plate is a convex lens; and / or the self-sealing interface is a rubber nozzle, the needle can be inserted to communicate, and the needle hole is automatically blocked after the needle is pulled out. A method for preventing blood leakage, using the above-mentioned arm fixing device for hemodialysis in nephrology, comprises the following steps: Wearing the device and starting dialysis; The device continuously monitors the blood leakage level L, the conduction intensity η and the diffusion time difference Δt; According to the monitoring results, the pressure adjustment increment in the transparent elastic membrane interlayer is calculated and executed, and the calculation process is as follows: Wherein, ΔP is the pressure value that needs to be increased; α is the blood leakage level weight coefficient; k is the pressure adjustment coefficient; η is the conduction intensity; L is the blood leakage level; β is the diffusion speed weight coefficient; Δt is the conduction time difference of adjacent conductive rings; and γ is the conduction compensation coefficient.

[0016] From the above technical solutions, the beneficial technical effects of the present application are as follows: The needle cavity, the needle body cavity and the needle handle fixing structure ensure stable puncture and fixation of the dialysis needle, and reduce the risk of shaking. The cover transparent plate facilitates direct observation of the puncture site, the transparent elastic membrane cooperates with the self-sealing interface to adjust the pressure, and the blood leakage is timely controlled. The fixing belt cooperates with the lock piece to tightly fix the device on the arm. The overall design effectively prevents the gap at the puncture site due to hand movement during dialysis, greatly reduces the risk of blood leakage, and ensures the safety of treatment. BRIEF DESCRIPTION OF DRAWINGS

[0017] In order to more clearly illustrate the technical solutions in the specific embodiments of the present application or the prior art, the drawings required to be used in the description of the specific embodiments or the prior art will be briefly introduced below. In all the drawings, similar elements or parts are generally identified by similar reference numerals. In the drawings, the elements or parts are not necessarily drawn according to the actual proportions.

[0018] Figure 1 It is an overall schematic diagram of the present application without a cover; Figure 2 It is a schematic diagram of the seat body of the present application without a cover; Figure 3 It is a schematic diagram of the seat body of the present application with a cover; Figure 4 It is a schematic diagram of the bottom of the seat body of the present application; Figure 5 It is a schematic diagram of the seat body and the cover of the present application separated; Figure 6 It is a schematic diagram of the inside of the air volume adjusting structure of the present application; Figure 7 It is a schematic diagram of the bottom of the cover of the present application; Figure 8 It is a schematic diagram of the present application Figure 7 It is a schematic diagram of the A-A cross section of the present application; Figure 9 It is a schematic diagram of the connection between the fixing belt and the seat body of the present application.

[0019] In the drawings: seat body 1, needle cavity 10, needle body cavity 11, needle handle seat 12, fixing nut 13, connecting rod 14, air volume adjusting structure 15, containing cavity 151, sliding plate 152, adjusting nut 153, elastic member 154, blood leakage detection film 16, conductive ring 161, cover cavity 20, transparent plate 21, elastic film 22, self-sealing interface 23, compression protrusion 24, fixing belt 3, air bag film 30, locking member 4. DETAILED DESCRIPTION

[0020] The embodiments of the technical solutions of the present application will be described in detail below with reference to the drawings. The following embodiments are only used to more clearly illustrate the technical solutions of the present application, and therefore only serve as examples, and cannot limit the protection scope of the present application.

[0021] It should be noted that, unless otherwise specified, the technical terms or scientific terms used in the present application should be understood as the usual meanings understood by the skilled person in the field to which the present application belongs.

[0022] The present embodiment provides a hand arm fixing device for hemodialysis in a nephrology department, and one possible implementation is: Referring to Figures 1-5 , the device includes a needle holder, a fixing belt 3, and a locking member 4; The needle rack comprises a buckled seat body 1 and a cover body, the seat body 1 is provided with a vertical needle cavity 10 and a needle body cavity 11 which penetrates the needle cavity 10 laterally, the needle body cavity 11 is provided with a needle handle fixing structure, the cover body is provided with a cover cavity 20 at a position corresponding to the needle cavity 10, a transparent plate 21 is arranged outside the cover cavity 20, and a transparent elastic film 22 is arranged inside the cover cavity 20, the elastic film 22 preferably uses an ultrathin and super-elastic rubber film, a sandwich is formed between the transparent plate 21 and the elastic film 22, and a self-sealing interface 23 is arranged on the cover body and communicates with the sandwich of the transparent plate 21 and the elastic film 22; two fixing bands 3 are fixedly connected to the two sides of the seat body 1 respectively, and a lock catch 4 is fixedly connected to the outer ends of the two fixing bands 3. The specific implementation of the lock catch 4 is not the core improvement point of the scheme, and can be referred to the watch and the belt.

[0023] In the above embodiment, the main working steps of the device are as follows: Device wearing preparation: the medical staff first opens the cover body, so that the needle cavity 10 and the needle body cavity 11 of the seat body 1 are completely exposed. The seat body 1 is stably placed at the position of the hand of the patient to be punctured, so that the puncture point is generally consistent with the center of the needle cavity 10, and the hand is ensured to be in a natural, comfortable and convenient puncture posture.

[0024] Fixing device: both hands hold the fixing bands 3 on both sides of the seat body 1 respectively, according to the thickness of the patient's hand, slowly stretch or relax the fixing bands 3, adjust the tightness of the fixing bands 3 through the lock catch 4 (the elastic hook and the card slot structure of the watch buckle can be referred to, and the pressing release button can quickly release; or the "day" buckle ring and the plug tongue structure of the belt buckle can be referred to, and the tightness is controlled by adjusting the plug tongue to be inserted into the hole position), until the seat body 1 is tightly and comfortably fixed with the hand, so as to avoid displacement in the subsequent operation and dialysis process.

[0025] Puncture fixation: the medical staff hold the dialysis needle, the needle head is inserted into the blood vessel of the patient's hand from the needle cavity 10 of the seat body 1, the needle handle is located in the needle handle fixing structure in the needle body cavity 11, the dialysis needle is ensured to be stably fixed on the seat body 1, and the needle body is prevented from shaking or shifting.

[0026] Covering the cover body: after completing the puncture fixation, the cover body is stably covered on the seat body 1, the cover body and the seat body 1 can be matched by buckling, the cover cavity 20 corresponds to the needle cavity 10. At this time, the transparent plate 21 outside the cover cavity 20 can clearly observe the situation around the needle head for the medical staff.

[0027] Pressurizing operation: medical staff use a syringe to slowly insert the needle tip into the self-sealing interface 23 on the cover, which automatically seals around the needle tip when the needle tip is inserted to prevent gas or liquid leakage. The self-sealing interface 23 can be a rubber nozzle, and the needle can be inserted into communication, and the needle is automatically blocked when it is pulled out. After the needle tip is inserted, the syringe is used to inject an appropriate amount of gas or transparent liquid into the interlayer between the transparent plate 21 and the transparent elastic membrane 22, causing the transparent elastic membrane 22 to gradually expand and uniformly occupy the cavity space, exerting appropriate pressure on the dialysis needle insertion site to reduce the risk of blood leakage.

[0028] Dialysis monitoring and adjustment: During dialysis, medical staff / patients can observe the situation around the needle tip in real time through the transparent plate 21. If blood leakage is found, an appropriate amount of gas or liquid can be injected into the interlayer through the self-sealing interface 23 using a syringe to further increase the pressure of the transparent elastic membrane 22 on the insertion site, effectively controlling blood leakage.

[0029] In the above embodiment, the clamping design of the device base 1 and the cover, as well as the setting of the needle handle fixing structure in the needle body cavity 11, can ensure that the dialysis needle remains stable during dialysis, avoiding damage to the puncture site or dialysis leakage due to shaking or displacement, improving the safety and stability of dialysis. The design of the transparent plate 21 on the outside of the cover cavity 20 allows medical staff to observe the skin and blood vessels around the needle tip directly and clearly, allowing them to detect abnormal phenomena such as blood leakage and blood seepage in a timely manner, providing convenience for timely treatment measures and helping to ensure the smooth progress of the dialysis process. By injecting gas or transparent liquid into the interlayer between the transparent plate 21 and the transparent elastic membrane 22, the transparent elastic membrane 22 expands and exerts pressure on the needle insertion site, allowing the pressure to be adjusted flexibly according to the actual situation of the patient. During dialysis, if there is slight blood leakage, the pressure can be increased at any time to effectively control blood leakage, reduce the risk of infection for the patient, and improve the safety and effectiveness of dialysis treatment.

[0030] In this embodiment, the cover is provided with a pressing protrusion 24 corresponding to the needle body cavity 11, which is made of elastic material and can press the needle body and block the needle body cavity 11, making the needle cavity 10 an independent cavity for the transparent elastic membrane 22 to expand and fully fill. The elastic membrane can uniformly press the insertion site to better control blood leakage and improve the stability and safety of blood transfusion treatment. The permeability of the expanded elastic membrane is also better to observe the condition of the insertion site.

[0031] The present embodiment has the advantages of Figure 9As shown, the needle handle fixing structure includes a needle handle seat 12 and a fixing nut 13, which can be located inside the cover, can pass through the cover, or can be provided with a notch at the corresponding position of the cover for the fixing nut 13 to pass through. After the medical staff accurately inserts the dialysis needle, places the needle handle at the tail of the needle in the needle handle seat 12, and tightens the fixing nut 13, it can be ensured that the dialysis needle is fixedly connected with the device to form an integral whole, and the device is fixed on the arm. Therefore, during the dialysis process, the movement of the arm will not cause the dialysis needle to loosen or even leak blood, thereby effectively avoiding the risk of blood leakage caused by the displacement of the needle body and ensuring the safety of the dialysis process.

[0032] The present embodiment is combined with Figure 1 and Figure 9 At least one air bag film 30 is arranged on each side of the fixing belt 3, and the air volume in each air bag film 30 can be adjusted. Specifically, on the side of the fixing belt 3 in contact with the hand, at least one recess is arranged on each side in the width direction, and the slot opening is closed by the air bag film 30 to form a cavity space. When wearing the device on the hand, the tightness of the device can be adjusted according to the middle part of the fixing belt 3 without the air bag film 30, and then the air volume of each air bag film 30 is adjusted to make the air bag film 30 bulge to form a better tightening effect. The use of flexible air bag film 30 as a supporting surface can automatically adapt to the shape of the arm, ensure uniform distribution of the tightening force, and ensure comfort during wearing. In summary, the tightness of the device is adjusted first by the middle part without the air bag film 30, and then the air volume of the air bag film 30 is adjusted as needed to tighten it. After the air bag film 30 bulges, not only is the tightening effect enhanced, but also the flexible material automatically conforms to the shape of the arm, so that the tightening force is evenly distributed. This not only effectively prevents the device from shifting, but also prevents local areas from being subjected to excessive pressure, greatly improving the comfort of wearing and ensuring the smooth progress of treatment.

[0033] In one possible embodiment, the air bag film 30 is also connected to the outside through a self-sealing interface 23, and the pressure or decompression adjusting force is adjusted by inserting a syringe. In another possible embodiment, the end of the seat body 1 is provided with a connecting rod 14, the connecting rod 14 is hollow, the two sides of the fixing belt 3 are respectively rotatably connected to the connecting rods 14 on the two sides of the seat body 1, and the rotatable connection interface is a sealed interface, as shown in Figure 9 The hollow areas of the connecting rods 14 on the two sides are also respectively communicated with the air bag films 30 of the fixing belts 3 on the two sides; and the connecting end of the connecting rod 14 and the seat body 1 is provided with an air volume adjusting structure 15, as shown in Figure 2 .

[0034] In this embodiment, the air volume adjusting structure 15 can independently adjust the air pressure of each air bag film 30, so that different air bag films 30 can have different degrees of bulging, that is, different compression forces. Its role is to prevent the local part of the arm from being compressed for a long time and affecting blood flow by adjusting the air volume difference in each air bag film 30, alternating compression and support of the hand, thereby ensuring that the device can be stably fixed on the arm on the basis of ensuring the comfort of the arm. In general, the degrees of bulging and compression forces of different air bag films 30 are different. In actual use, the hand can be alternately compressed and supported, and the local part of the arm can be cleverly avoided for a long time. The normal flow of blood is ensured, and the discomfort and even blood circulation disorders caused by compression are effectively prevented. At the same time, this dynamic adjustment method ensures the comfort of the arm and keeps the device always stably fixed on the arm, providing reliable support for the dialysis treatment process, and taking into account the comfort and stability.

[0035] On the basis of the above-mentioned embodiments, as shown in Figure 6 The air volume adjusting structure 15 includes a containing cavity 151, a sliding plate 152, an adjusting nut 153, and an elastic member 154. The containing cavity 151 is in communication with the inside of the connecting rod 14, the sliding plate 152 is slidingly arranged in the containing cavity 151, the elastic member 154 is arranged between the containing cavity 151 and the sliding plate 152, and the adjusting nut 153 is threadedly connected with the cover body and abuts against the sliding plate 152. When the adjusting nut 153 is screwed, the adjusting nut 153 can press down the sliding plate 152 or make the sliding plate 152 move upward under the action of the elastic member 154.

[0036] The design of the air volume adjusting structure 15 in the above-mentioned embodiments brings significant advantages to the use of the device. The containing cavity 151 is in communication with the inside of the connecting rod 14, the sliding plate 152 is slidingly arranged therein, the elastic member 154 provides a reset elastic force, the adjusting nut 153 is threadedly connected with the cover body and abuts against the sliding plate 152, and the air volume of the air bag film 30 (the volume of the containing cavity 151) can be adjusted by screwing the adjusting nut 153. In actual application, in addition to the initial air volume being adjusted by the self-sealing interface of the syringe, the patient can also flexibly adjust the compression force of each air bag film 30 according to the real-time comfort level of the hand. Since the volume of the containing cavity 151 is small, the overall device will not be loose during adjustment, but it is sufficient to form appropriate differences in compression forces among different air bag films 30. This design not only ensures the stable fixation of the device on the arm, but also fully meets the individual needs of patients, ensures the comfort of the hand, effectively improves the patient experience, avoids discomfort caused by long-term compression of the same part, and ensures that the dialysis treatment process can be carried out smoothly and comfortably.

[0037] This embodiment is Figure 9As shown, the bottom side of the needle cavity 10 is provided with a blood leakage detection film 16, which is transparent but not conductive. The middle of the blood leakage detection film 16 has a hole for the needle to pass through. A plurality of conductive rings 161 are arranged concentrically and spaced apart from the hole. The conductive rings can be metal wires or conductive coatings. Each conductive ring is connected to a detection circuit. Initially, the transparent elastic film 22 is inflated and pressed on the blood leakage detection film 16. Once blood leakage occurs at the needle puncture site, the blood will be pressed between the transparent elastic film 22 and the blood leakage detection film 16 under the pressure of the transparent elastic film 22. The blood will be blocked and the blood leakage will be inhibited. If the blood cannot be blocked, it will spread outward in a planar manner. Thus, the blood will cross the conductive rings 161. The innermost conductive ring 161 is the first ring, and the second and third rings are arranged outward in sequence. When the blood leakage is small, the blood crosses the first and second rings, and the detection circuit can detect that the first and second rings are conductive. At this time, the transparent elastic film 22 can be appropriately pressurized to increase the pressing force on the needle puncture site. If the blood leakage still occurs, the blood spreads outward to the third ring. At this time, the first and third rings are conductive, and the transparent elastic film 22 needs to be appropriately pressurized to increase the pressing force on the needle puncture site. If the conductive rings are still detected after multiple turns, it means that the blood leakage is relatively serious, and the compression cannot effectively stop the bleeding. An alarm can be sounded or a light can be emitted to remind medical personnel to handle it.

[0038] The present embodiment provides a blood leakage prevention method using the device of the above embodiment. A controller is arranged in the device to monitor the blood leakage and adjust the pressure of the transparent elastic film 22. The controller is a conventional technical means and is not the core improvement point of the present scheme. The method comprises the following steps: After the device is worn, the needle passes through the hole in the middle of the blood leakage detection film 16 and penetrates into the human body. The needle is fixed to the device body, and then the transparent elastic film 22 is pressurized to contact and press the needle and the puncture area after inflation. Dialysis begins.

[0039] Monitoring step: The device continuously monitors the state of the conductive ring(s) 161, including three values: blood leakage level L, conduction strength η, and diffusion time difference Δt.

[0040] Blood leakage level L: L=2 (unitless) when the first and second conductive rings are conductive, L=3 when the first, second, and third conductive rings are conductive, and so on. Conduction strength η: current electric flux / full conduction electric flux, value 0.0-1.0. Taking blood leakage level L=2 as an example, when the 360-degree range of the first and second rings is connected by blood, the conduction strength η=1.0. If only a local (sector) area is connected by blood, the conduction strength η<1 (unitless). Diffusion time difference Δt: the time interval (seconds) of the conduction of adjacent conductive rings when the blood leakage level L increases.

[0041] According to the values obtained in the monitoring step, the pressure adjustment increment in the transparent elastic membrane interlayer is calculated and executed (the degree of bulging of the transparent elastic membrane 22 is increased, and the pressing force on the puncture point is increased), and the calculation process is as follows: Wherein, ΔP is the pressure value that needs to be increased (achieved by injecting medium into the transparent elastic membrane, which may need to set a micro piston in the device, the piston cavity is connected to the transparent elastic membrane, and the pressure in the transparent elastic membrane can be adjusted by adjusting the sliding position of the piston through the extension power source); k is the pressure adjustment coefficient (device calibration constant); α is the leakage weight coefficient (clinical calibration constant); η is the conduction intensity: the current conduction of the conductive ring / the conduction when all the 360-degree range of the conductive ring is conducted by blood (0-1 range); L is the leakage level: the number of conductive ring circles covered by blood diffusion (counted from inside to outside); β is the diffusion speed weight coefficient (clinical calibration constant); Δt is the conduction time difference of adjacent conductive rings (such as the time taken for blood to diffuse from L=1 circle to L=2 circle, seconds); γ is the conduction compensation coefficient (local leakage risk weight, clinical calibration constant).

[0042] When L increases (the leakage diffusion range expands, indicating that the leakage exists and is expanding), the pressure needs to be increased linearly; when η decreases (indicating local area diffusion, not 360-degree diffusion), the latter term in the formula reduces the pressure intensity response; when Δt decreases (diffusion accelerates), the pressure needs to be increased. In actual application, when L≥Lmax (such as 4 circles) or the cumulative value of ΔP exceeds the safety threshold, an alarm should be triggered instead of continuing to increase the pressure.

[0043] In the above embodiment, the calibration of the pressure adjustment coefficient (k) is achieved by implanting a micro pressure sensor at the bottom of the seat body 1 (wearing a simulated prosthesis, setting a simulated needle, and setting a pressure sensor at the puncture position): the transparent elastic membrane 22 increases the pressure in stages, and the actual pressure applied by the transparent elastic membrane 22 to the simulated blood vessel is recorded synchronously, a linear model of injection volume and pressure change is established (k=ΔP / ΔV×membrane effective area), and the k value of obese patients needs to be increased by about 20% due to thicker subcutaneous tissue, and the k value of emaciated patients needs to be decreased by 15%.

[0044] The calibration of the leakage weight coefficient (α) depends on the extracorporeal circulation simulation system: a artificial blood vessel is implanted in the needle cavity 10, and a graded leakage is artificially created-when the blood only covers the innermost conductive ring (L=1), the reference hemostatic pressure P1 is recorded; when it diffuses to the second circle (L=2), P2 is recorded; the coefficient is calculated by the formula α=(P2-P1) / (k·η), and for example, the clinical data shows that each additional circle of diffusion needs to increase the pressure by 30%-50%, and α can be taken as 0.7-1.2.

[0045] The calibration of the diffusion speed weight coefficient (β) focuses on time sensitivity: control the blood to diffuse at a speed of 0.5-5 mm / s, and statistically analyze the relationship between the diffusion time Δt and the hemostatic pressure in at least 200 dialysis cases. For example, if Δt is shortened by 50%, the pressure needs to be increased by 30%. Thus, β = critical time t_crit × k × α (t_crit can be the maximum diffusion time allowed in clinical practice, which is 2.0 seconds).

[0046] The measurement and calibration of the conduction strength (η) involve hardware calibration: before dialysis, a standard conductive liquid (simulated blood) is dripped on the blood leakage detection membrane 16, and the whole range of 360 degrees is conduction by appropriate squeezing. The full conduction electric flux I_full is recorded as a reference. In actual use, η = real-time electric flux / I_full, and the change of blood conductivity with body temperature is compensated by the temperature sensor of the seat body 1.

[0047] The calibration of the conduction compensation coefficient (γ) is aimed at high-risk scenarios: simulate point bleeding caused by needle puncture of blood vessels, and measure the pressure P_puncture required for hemostasis. Compared with the normal leakage pressure P_normal, γ = (P_puncture - P_normal) / (k(1-η)) is calculated. When blood only leaks in a very small range (the conduction strength η is close to 0) — for example, due to uneven squeezing of the transparent elastic membrane, a local sealing interface is formed to prevent blood from diffusing in a certain direction, and blood can only diffuse in a certain direction (such as along the needle direction) — the conventional algorithm may underestimate the risk. At this time, γ will significantly increase the pressure: if η is small, γ will additionally increase the basic pressure, ensuring that enough compression force is applied to the bleeding point in the above-mentioned case. In short, γ is an insurance for the special scenario of "small diffusion range but fast speed".

[0048] In this embodiment, the transparent plate 21 is a convex lens. In medical scenarios such as hemodialysis, medical staff need to closely observe the needle puncture site to ensure safe and effective treatment. The transparent plate 21, as a convex lens, has a unique optical magnification effect. When light passes through its surface, it will focus and magnify the image of the needle puncture site. This allows medical staff to clearly and carefully see the blood vessel state, bleeding, coagulation, and other subtle changes at the needle puncture site by observing the cover cavity 20 area without the need for additional magnification equipment. Even small hematoma formation or slight needle displacement signs can be captured in time, allowing medical staff to make accurate judgments quickly and take targeted measures such as adjusting the tightness of the fixing belt 3, adjusting the compression force of the air bag membrane 30, adjusting the compression force of the transparent elastic membrane 22, or even stopping dialysis, thereby effectively preventing complications such as blood leakage and infection, and improving treatment safety and quality.

[0049] It should be pointed out finally that the above embodiments are only used to illustrate the technical solutions of the present application, but not to limit the same; although the present application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that the technical solutions recorded in the foregoing embodiments can still be modified, or some or all of the technical features can be replaced equivalently; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present application, and they should be covered in the scope of the claims and the specification of the present application.

Claims

1. An arm fixation device for hemodialysis in nephrology, characterized in that: Includes needle holder, fixing strap (3) and locking fastener (4); The needle holder includes a snap-fit ​​base (1) and a cover. The base (1) has a vertically penetrating needle tip cavity (10) and a needle body cavity (11) that penetrates laterally into the needle tip cavity (10). The needle body cavity (11) has a needle handle fixing structure. The cover has a cover cavity (20) at a position corresponding to the needle tip cavity (10). A transparent plate (21) is provided on the outside of the cover cavity (20), and a transparent elastic membrane (22) is provided on the inside. A self-sealing interface (23) is provided on the cover to communicate with the transparent plate (21) and the elastic membrane interlayer. The two fixing straps (3) are fixedly connected to the two sides of the seat (1) respectively, and the locking buckle (4) is fixedly connected to the outer ends of the two fixing straps (3).

2. The arm fixation device for nephrology hemodialysis as described in claim 1, characterized in that, A pressing protrusion (24) is provided on the cover at a position corresponding to the needle cavity (11), and the pressing protrusion (24) is made of elastic material.

3. The arm fixation device for nephrology hemodialysis as described in claim 1, characterized in that, The needle handle fixing structure includes a needle handle seat (12) and a fixing nut (13).

4. The arm fixation device for nephrology hemodialysis as described in claim 1, characterized in that, At least one airbag membrane (30) is provided on each side of the fixing belt (3), and the amount of air in each airbag membrane (30) can be adjusted.

5. The arm fixation device for nephrology hemodialysis as described in claim 4, characterized in that, The airbag membrane (30) is also connected to the outside through a self-sealing interface.

6. The arm fixation device for nephrology hemodialysis as described in claim 4, characterized in that: The end of the seat (1) is provided with a connecting rod (14), the connecting rod (14) is hollow, and the two sides of the fixing strap (3) are rotatably connected to the connecting rod (14) on both sides of the seat (1). The hollow areas of the connecting rod (14) on both sides are also connected to the airbag membrane (30) of the fixing strap (3) on both sides. The connection end between the connecting rod (14) and the seat (1) is provided with an air volume adjustment structure (15).

7. The arm fixation device for nephrology hemodialysis as described in claim 6, characterized in that: The air volume regulating structure (15) includes a receiving cavity (151), a sliding plate (152), an adjusting nut (153), and an elastic element (154). The receiving cavity (151) is connected to the inside of the connecting rod (14), the sliding plate (152) is slidably disposed in the receiving cavity (151), the elastic element (154) is disposed between the receiving cavity (151) and the sliding plate (152), and the adjusting nut (153) is threadedly connected to the cover and abuts against the sliding plate (152).

8. The arm fixation device for nephrology hemodialysis as described in claim 1, characterized in that: A blood leakage detection membrane (16) is provided on one side of the bottom of the needle cavity (10). The blood leakage detection membrane (16) has a hole in the middle for the needle to pass through, and multiple conductive rings (161) are arranged concentrically with the hole.

9. The arm fixation device for nephrology hemodialysis as described in claim 1, characterized in that, The transparent plate (21) is a convex lens; and / or, the self-sealing interface (23) is a rubber nozzle, which allows the needle to be inserted and connected, and automatically seals the needle hole when the needle is pulled out.

10. A method for preventing blood leakage, employing the arm fixation device for nephrology hemodialysis as described in claim 8, characterized in that, Includes the following steps: Wear the device and begin dialysis; The device continuously monitors the blood leakage level L, conductivity η, and diffusion time difference Δt; Based on the monitoring results, the pressure adjustment increment within the transparent elastic membrane interlayer is calculated and executed. The calculation process is as follows: Wherein, ΔP is the pressure value that needs to be increased; α is the weighting coefficient for the blood leakage level; k is the pressure adjustment coefficient; η is the conductivity; L is the blood leakage level; β is the diffusion rate weighting coefficient; Δt is the conduction time difference between adjacent conductive rings; and γ is the conduction compensation coefficient.