PUSH BREAK AID

DE502021007708D1Active Publication Date: 2025-06-26FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
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Patent Information

Application Number
DE502021007708
Authority / Receiving Office
DE · DE
Patent Type
Patents
Current Assignee / Owner
Priority Date
2020-03-05
Filing Date
2021-03-02
Publication Date
2025-06-26
Estimated Expiration
2041-03-02

AI Technical Summary

Technical Problem

Existing pressure-application aids for venous access after hemodialysis are prone to incorrect pressure adjustment, affected by muscle tension and arm circumference changes, leading to potential damage or discomfort.

Method used

A pressure-exerting aid featuring a circumferential band with an adjustable circumference and a constant force spring, which maintains a consistent force over a specific range, along with a display element to indicate the spring's deflection and an optional emergency compression mechanism.

Benefits of technology

The solution ensures consistent and reliable pressure application, reducing the risk of damage to the venous access and enhancing user comfort by compensating for muscle movements and providing emergency compression if needed.

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Description

[0001] The present invention relates to a pressure-application aid for pressure-application of a puncture site, in particular a venous access of a patient.

[0002] After hemodialysis treatment, the patient is usually heparinized, meaning blood clotting is still negatively affected. As a result, the venous access must be closed after the dialysis machine needle has been disconnected.

[0003] State-of-the-art pressure-pulling aids are generally based on a simple spring-loaded mechanism. The force applied to the puncture site can be adjusted using a rotary knob. This is achieved using a screw mechanism (force-displacement relationship). This has the disadvantage that the applied pressure can be incorrectly adjusted. An even more disadvantageous factor is that movement / muscle tension, i.e., changes in arm circumference, can affect the applied pressure force, which can potentially lead to damage to the venous access and, at the very least, is uncomfortable to wear.

[0004] Apart from that, the known impression aids are not flat and therefore do not fit well under the patient's clothing.

[0005] It is also known from the prior art to use a compressor and an air cushion to dynamically apply pressure to the puncture site. In this way, the applied force or pressure can always be kept within the ideal range. However, its implementation is comparatively complex (medical device software and hardware). Among other things, a rechargeable battery is required to operate the device. Availability is therefore only guaranteed if the battery is regularly fully charged, etc. Furthermore, the portability of the device is another disadvantage compared to mechanical solutions.

[0006] An example of prior art is US2019 / 247054A1. CN107714132A discloses a band for taking an impression of an arm. US2014 / 135819A1 discloses a neoprene band for taking an impression of an arm or leg. Another impression aid is known from DE102013112597A1. WO2019 / 017828A1 discloses a medical compression device. Another impression aid is disclosed in US2018 / 187703A1. US2006 / 201522A1 discloses a compression strip with an indicator element.

[0007] The present invention is therefore based on the object of providing a bead-pulling aid which is reliable to operate and has a simple structure.

[0008] This object is achieved by a pressure-exerting aid with the features of claim 1. According to this, the pressure-exerting aid comprises a circumferential band whose circumference is adjustable, with a constant force spring arranged in the circumferential band. A constant force spring has the advantage that, unlike a conventional spring, it exerts or regulates a constant force over a specific travel or stroke. This makes it possible to reduce the probability of too little or too much pressure being exerted on the puncture site. It is sufficient for the user to adjust the pressure-exerting aid so that the stroke or deflection lies within the constant force range. The invention thus provides a constant force spring which offers partial independence between force and travel. Possible implementations are purely mechanical or magnetic.

[0009] According to the invention, a display element is preferably located on the outside of the constant-force spring, which is designed to directly or indirectly indicate the deflection of the constant-force spring. This allows the user to determine whether the constant-force range has already been reached, fallen below, or even exceeded. The purpose of the display is to allow the constant-force spring to be deflected centrally, thus achieving the largest possible control range. The force exerted by the spring cannot be directly influenced by this.

[0010] The advantage of the display is the optimization of the action range in which the spring can keep the force constant.

[0011] According to the invention, the display element is designed to show the user the range of the constant force.

[0012] It is conceivable that an element could be provided that could increase the applied force beyond the constant force range provided by the constant force spring. This element serves to compress the puncture site more firmly by means of a closure in the event of excessive tightening outside the ideal position (center of the constant force range) or in an emergency, in order to stop bleeding. For this purpose, the element could, for example, partially have a conventional spring constant (elastic modulus) up to a stop or be designed as a type of "safety chain."

[0013] Especially in an emergency, it may be necessary to apply a force to the puncture site that exceeds the ideal force of the constant spring. However, this emergency compression should also be limited or even unlimited (stop). In an emergency, compression can be applied at your own discretion.

[0014] For this purpose, two (non-limiting) exemplary alternatives can be considered, each of which is / are attached to the belt parallel and detached from the actual release spring: 1) A safety element, such as a safety chain, which ensures that the "tightening travel" does not exceed a critical point (max.). By limiting the tightening travel, the applied force is also limited. This limitation is intended to prevent the force of the constant force spring from decreasing if the tightening is too strong (see characteristic curve in Figure 2). As soon as the spring is outside the range between min. and max., it may no longer provide any force, meaning the bead breaker could detach completely, splitting into two pieces. 2) Version with spring. An additional scale can be optionally provided for this purpose, indicating the applied force relative to the elastic modulus of the material used. This allows for fine adjustment in the end range of the maximum exertable force.

[0015] The spring stiffness can be designed relative to the characteristic curve of the counterforce spring, in particular taking into account the point P1, ie the ideal position.

[0016] It must be ensured that the strap closure does not slip or open accidentally, even with the maximum force that can be exerted.

[0017] Thus, one conceivable embodiment is that the element is a spring which preferably has a linear relationship between stroke and force at least in some areas, ie like a conventional spring.

[0018] Preferably, said element is connected in parallel with the constant-force spring. A serial connection is also conceivable and encompassed by the invention.

[0019] A serial connection, possibly in combination with a stop, is useful, so that when the constant force spring is overextended to the stop, it then remains and the conventional spring connected in series then provides a force-stroke characteristic curve above the force of the constant force spring.

[0020] The strap can have two ends, with one end being insertable into the other end and lockable there, as is known from cable ties. Other closures are also encompassed by the invention.

[0021] Preferably, the band is provided with a closure that can be released manually (reuse, removal of the pressure aid).

[0022] The constant force spring can be mechanical and / or magnetic. The term "spring" is therefore broadly interpreted and includes magnetic versions or, for example, purely mechanical variants.

[0023] It is conceivable that the impression aid could be color-coded, correlating with the force applied by the constant-force spring. This would immediately show the user which constant force can be achieved with which impression aid. This would also reduce the risk of incorrect use due to confusion between the available impression aids, as patients would eventually learn their strength, i.e., the color, and it would be obvious to them if the staff gave them the wrong impression aid.

[0024] The present disclosure also relates to a method for pressing a puncture site, such as a fistula or other blood vessel, in particular the access(s) of a dialysis patient.

[0025] The pressure relief device is used when the needle or cannula has been removed, for example after dialysis treatment.

[0026] It should be noted here that the terms "a" and "an" do not necessarily refer to exactly one of the elements, although this is a possible interpretation, but can also refer to a plurality of the elements. Likewise, the use of the plural also includes the presence of the element in question in the singular, and conversely, the singular also encompasses several of the elements in question.

[0027] Further details and advantages of the invention are explained in more detail with reference to an embodiment shown in the drawing.

[0028] They show: Figure 1: a perspective view of a pressure relief device according to the invention and Figure 2: force-displacement curves of a conventional spring and a constant force spring.

[0029] Figure 1 shows a perspective view of a pressure relief aid according to the invention.

[0030] The bead breaking aid consists of a circumferential band 10 in which a constant force spring 20 is integrated over a partial circumference. As can be seen from Figure 2b This spring has the advantage that it exerts a constant force on the puncture site over a certain stroke. This differs from the characteristic curve of a conventional spring according to Figure 2a , in which the applied force increases linearly with the deflection, i.e. the stroke.

[0031] The constant force spring ensures that the force with which the band is pressed against the puncture site remains constant over a certain stroke. The ideal position is Figure 2b marked with the reference symbol P1. This position represents the center of the stroke at constant force.

[0032] The reference numeral 30 denotes an element in the form of a conventional spring, which as in Figure 1 shown arranged in parallel or in series with the constant force spring 10. In a preferred embodiment, however, the conventional spring is not present.

[0033] This element 30 serves to compress the puncture site more firmly using the closure 40 in case of excessive tightening outside the ideal position P1 or in an emergency, in order to stop bleeding. For this purpose, the element 30 can, for example, partially have a conventional spring constant (elastic modulus) up to a stop or be designed as a type of "safety chain."

[0034] As from Figure 1 The strap can be designed as a cable tie or as a cable tie. The term "strap" is to be interpreted broadly and includes, for example, cuffs, etc.

[0035] The reference number 50 designates a scale in the form of a transparent window (e.g. made of plastic), which is preferably located above the constant force spring.

[0036] The scale has a max. and min. marking that indicates the constant force range. It is used for ideal tightening of the cable tie or other strap. Between the max. and min. markings is the normal range, which Figure 2b marked P1.

[0037] The closure 40 can also be reopened (reuse, removal of the pressure relief device).

[0038] Different strengths of the push-off aid (constant force spring) can be offered, also taking into account the forearm circumference of a person / patient. This can be indicated, for example, by color-coding the "push-off aid / wristband."

[0039] In a preferred embodiment, the advantages over the prior art are: Intrinsically safe, as the constant force spring prevents excessive compression unless the aforementioned element is provided. If this is provided, the scale makes it clear to the operator that they are leaving the area of ​​mechanical pressure regulation by the constant force spring element. Preferably, the compression aid can be opened manually using the closure. Simple in design and therefore inexpensive. No expensive and complex hardware and software development required. Simplified risk analysis. Increased wearing comfort (due to slim design without wiring) and mechanical pressure regulation by constant force spring. Stop for tightening in an emergency if blood loss is imminent. Risk of damage to the venous access is reduced. Compensation of muscle movements with the arm / hand (mechanical control). Easy to use, i.e. can also be used at home by personnel with little training.High availability (no battery and no charge level dependency, etc.). Reusable or disposable for hygiene reasons. Greater user confidence, as the risk of overtightening is mitigated or prevented by the design. Easier technical implementation without significant sustainment effort (electronic hardware discontinuation, etc.). Can be implemented more cost-effectively.

Claims

1. Compression aid for compressing a puncture site of a patient, wherein the compression aid comprises a peripheral band (10) whose circumference can be adjusted, wherein a constant force spring (20) is arranged in the peripheral band (10) and an indicator (50) is located on the constant force spring (20), preferably on the outer side of the constant force spring (20), and is configured to indicate the deflection of the constant force spring (20) and to indicate the range of the constant force to the user.

2. Compression aid in accordance with claim 1, characterized in that an element is provided by means of which the exerted force can be increased over the range of the constant force applied by the constant force spring (20).

3. Compression aid in accordance with claim 2, characterized in that the element is a spring that preferably at least regionally has a linear dependency between the stroke and the force.

4. Compression aid in accordance with claim 2 or claim 3, characterized in that the element is connected in parallel with the constant force spring (20).

5. Compression aid in accordance with any one of the preceding claims, characterized in that the band (10) comprises two ends, wherein the one end of the band (10) is insertable into the other end of the band (10) and is fixable there.

6. Compression aid in accordance with any one of the preceding claims, characterized in that the band (10) comprises a manually releasable closure (40).

7. Compression aid in accordance with any one of the preceding claims, characterized in that the constant force spring (20) is configured as mechanical and / or magnetic spring.

8. Compression aid in accordance with any one of the preceding claims, characterized in that the compression aid comprises a color coding that is correlated with the force applied by the constant force spring (20).