RU197952U1 - Device for intraosseous access - Google Patents

Abstract

The device relates to medical equipment and can be used to inject drugs directly into the bone. A device for intraosseous access, consisting of a handle with a mandrin stylet, a stopper connection with a needle attached to it, which has a nozzle into which it is installed by mechanical expansion , the sharpening angles of the mandrel stylet and the needle are 48 ° + -15 'and 22 ° + -15', and the handle of the mandrel stylet is made of two parts connected by a threaded connection - cylindrical and mushroom-shaped. Technical result - simplified intraosseous access.

Description

The device relates to medical equipment and can be used to inject drugs directly into the bone. Designed for emergency medical care, outpatient and inpatient medical facilities, for patients who require access to the vascular system in difficult cases (17%) and cases when intravenous access is not possible at all (15%).

Intraosseous access is an alternative to venous (dehydration, burns, scars on the skin, obese patients, terminal condition, etc.). The intraosseous space is a descending vein. Fluids and drugs reach the central bloodstream in a few seconds. A device for intra-bone access to the human vascular system allows for reliable and stable infusion for patients of all ages and weights. With intraosseous access, pain is equivalent to installing a peripheral intravenous catheter without local anesthesia. The installation time for the device for intraosseous access does not exceed 10 seconds, which is extremely important when providing emergency medical care and intensive care.

This product is included in the regulations for equipping ambulance crews in Russia (order of the Ministry of Health of the Russian Federation No. 38n of 06/20/2013 and order of the Ministry of Health of the Russian Federation No. 36n of January 22, 2016 “On approval of requirements for packaging of drugs and medical products for laying and kits for emergency medical care. ”However, only imported devices appear on the Russian medical market.

Known American cordless electric drill EZ-IO with a set of needles [US 2016183974 A1, 06/30/2016].

The disadvantage of this product is an external power source, the need to control the charge and change the battery pack.

A well-known analogue is the Israeli single-shot pistol Bone Ingection Gun [http://ps-med.com/products/vascular/BIG-RSYS-A]. The disadvantage of this device is the complexity of manufacturing.

Known automatic "shock" disposable device for intraosseous access NIO, developed by the American company PerSys Medical [http://www.nio-pm.com].

Known intraosseous needle "Juice Intraosseous Needle" company Cookmedical, USA [https://www.cookmedical.com/products/cc_dinl35_webds]. The needle is used as an alternative to intravenous access, allowing the infusion of drugs and fluids during childhood emergencies. The product is delivered sterile and packaged. It is intended for single use. The product consists of a needle and mandrel. The latter at one end contains a handle, and the other end is made in the form of a sharpened drill and will stand out of the needle.

Intraosseous needle "Juice Intraosseous Needle" is intended for children's practice. Due to the denser bone tissue of adults, an attempt to use it for intraosseous access is not justified. To overcome the denser cortical plate of bone tissue of adult patients, other strength characteristics of the needle materials are required.

In this device, the needle and mandrel stylet are connected using thread. At the same time, tightening is possible on the thread, which will complicate the separation of the parts of the device. In this case, a force is required to twist. You need to hold the needle and twist the device by the handle. In order to remove the device from the body after use, it is necessary to screw the handle with the stylet back on. It is necessary to maintain sterility, which creates additional difficulties and the likelihood of infection. Often the process of use occurs in emergency conditions, on the street and maintain sterility is very difficult.

When threaded, the sharpened parts of the needle and stylet may not match.

The closest technical solution is the device for intraosseous access, consisting of a handle with a mandrin stylet, a stopper connection with a needle attached to it. The stopper connection is made in the form of a coil, and for fixation, its upper part has two or more non-parallel planes, one or more collars, and the lower part of the internal recess of the handle has two or more non-parallel planes for exact coincidence with the counterpart of the stopper connection and further rounded interior with a groove [RU 175101 U1 11/21/2017].

The disadvantage of the technical solution is the high material consumption of manufacturing, since the handle is machined from a single piece of metal on the machine and it is necessary to use a workpiece with a maximum cross-section along the width of the mushroom-shaped part of the handle. In addition, the handle when used in medicine should have different colors in accordance with color coding and it is necessary to cover its entirety. Another processing flaw to ensure sterility.

The technical result is the simplification of intraosseous access.

The technical result is achieved by the device for intraosseous access, consisting of a handle with a mandrin stylet, a stopper connection with a needle attached to it, which has a nozzle into which it is installed by mechanical expansion, the sharpening angles of the mandrin stylet and the needle are 48 ° + -15 'and 22 ° + -15', and the mandrel-stylet handle is made of two parts connected by a threaded connection - cylindrical and mushroom-shaped.

The device for intraosseous access consists of two detachable parts: a needle and a mandrin stylet. The needle is made of high strength steel. Its free end has additional processing and sharpening. The second end of the needle ends with a cannula for attaching an infusion system or standard syringe. The mandrin stiletto is in the lumen of the needle. One end of it has a trocar sharpening at an optimal angle and will stand out of the needle. The second end of the mandrel stylet ends with an ergonomic handle that is comfortable to grip, which facilitates penetration (penetration through a dense vertical plate into the spongy bone). Improved ergonomics of the handle is achieved by using a mushroom-shaped part whose width is 32 mm, the radius of its upper part is 17.14 mm, and the radius of curvature of the lower part is 5 mm.

The device for intraosseous access has the following advantages:

- special processing and sharpening of the needle;

- special processing and trocar sharpening at the optimum angle of the free end of the mandrel stylet, facilitating penetration;

- the presence of a stopper in the detachable connection of the needle and the mandrel-stylet for the safety of the procedure;

- ergonomic handle of the mandrel-stylet, which allows you to make the necessary effort to implement minimally invasive intraosseous access;

- lack of an external power source or batteries that require maintenance.

- the implementation of the handle of two parts connected by a threaded connection - cylindrical and mushroom-shaped, which can significantly reduce the material consumption in the manufacture.

- improved ergonomics is achieved using the mushroom-shaped part of the handle, the width of which is 32 mm, the radius of its upper part is 17.14 mm, and the radius of curvature of the lower part is 5 mm.

Thus, thanks to the combination of several elements, the device allows for minimally invasive intraosseous access within 3-5 seconds by simple manipulations in patients of any age while providing emergency medical care. Namely, a special sharpening of the needle, trocar sharpening at the optimal angle of the mandrel stylet, the presence of a stopper in the detachable connection of the needle and mandrel stylet, the ergonomic handle of the mandrel stylet. And the implementation of the handle in two parts connected by a threaded connection - cylindrical and mushroom-shaped can significantly reduce the consumption of materials in the manufacture. In addition, the handle does not need to be disinfected, which simplifies the process of intraosseous access.

The figure 1 shows the removed mushroom-shaped part of the handle of the intraosseous access device. In figure 2 - connected by a threaded connection - cylindrical and mushroom-shaped parts of the handle. The figure 3 presents a photo of the mandrin stiletto. The painting of the mushroom-shaped part is visible in accordance with the necessary color coding. The figure 4 presents a photo of the unscrewed cylindrical part of the mandrin-stylet.

The sharpening angles of the stylet and needle mandrenes are 48 ° + -15 'and 22 ° + -15'.

These sharpening angles do not injure the bone, do not break it off at the end of the movement.

First, cutting occurs with short edges - 48 ° + -15 ', and then with faces with sharpening angles of 22 ° + -15'.

The sharpening angles in these values allow for uniform penetration into the bone tissue without significant effort and in a short time. For penetration, an effort of 800 grams is enough.

The device for intraosseous access consists of two detachable parts: a needle and a mandrin stylet. The needle is made of high strength steel. Its free end has additional processing and sharpening. The second end of the needle ends with a cannula for attaching an infusion system or standard syringe. The mandrin stiletto is in the lumen of the needle. One end of it has a trocar sharpening at an optimal angle and will stand out of the needle. The second end of the mandrel stylet ends with an ergonomic handle that is comfortable to grip, which facilitates penetration (penetration through a dense vertical plate into the spongy bone).

The device for intraosseous access has the following advantages:

- special processing and sharpening of the edges of the needle: 48 ° + -15 'and 22 ° + -15'.

- special processing and trocar sharpening at the optimal angle of the free end of the mandrel stylet, facilitating penetration: 48 ° + -15 'and 22 ° + -15'.

The figure 5 shows the angle of sharpening of the needle at 48 °. In the figure 6 - 22 °. The figure 7 shows the angle of sharpening of the mandrel stylet at 48 °, in figure 8 - 22 °.

We used the following options for sharpening the edges of the needle and mandrin stylet:

54 ° + -15 '- 30 ° + -15'

50 ° + -15 '- 24 ° + -15'

48 ° + -15 '- 15 ° + -15'

37 ° + -15 '- 15 ° + -15'

37 ° + -15 '- 22 ° + -15'

In all cases except sharpening angles 48 ° + -15 '- 15 ° + -15'

Penetration occurred from 30 to 6 seconds. And only when using a needle with a sharpening angle of 48 ° + -15 '- 15 ° + -15', only 3-5 seconds were required for high-quality penetration into the bone.

After 3-5 seconds, the cortical plate of the bone was penetrated and the needle was completely immersed in the spongy bone. After removing the styrene mandrel, it becomes possible to connect an infusion system or syringe to the cannula needle.

The stopper connection with the needle with the nozzle into which it is installed by mechanical expansion, eliminates its separation at the time of extraction, thus simplifying the process of intraosseous access.

In addition, when the needle is inserted into the stopper assembly, its deformation is excluded, since the pressing-in occurs by pressure on the nozzle, and not on the needle itself.

The figure 9 shows the connection-stopper in the context before installing the needle. Figure 10 is a photo of the product before installing the needle. In figure 11 - a needle with a nozzle before installation in the connection-stopper. Figure 12 is a photo of the needle with the nozzle before installation in the connection-stopper. The figure 13 shows a photo of the connection of the stopper with the installed needle. In figure 14 - the needle after sharpening. In the figure 15 is a needle inserted into the bone tissue. Figure 16 shows the LUER lock connection for installing an infusion system. In figure 17 - a complete set of devices for intraosseous access: a handle with a mandrin-stylet, connection-stopper with a needle, a protective cap.

The device operates as follows.

Before starting any preparatory actions are required. The device is ready for use and is assembled. In this case, the mandrel stylet is located in the lumen of the needle and is connected to it using a detachable connection-stopper.

Device for intraosseous access is used as follows. Firmly holding the device for intraosseous access with one hand and pressing the handle, we perforate the skin with the trocar end of the mandrel-stylet. Without weakening the pressure, rotate the handle in the direction and counterclockwise. After penetration of the cortical plate of the bone, a failure is felt and the needle is completely immersed in the spongy substance of the bone. The mandrel stylet is separated from the needle in a detachable stopper and removed from the needle. After that, an infusion system or a standard syringe is connected to the needle cannula.

After carrying out the procedure for removing the device, it is not necessary to connect the mandrel stylet and the needle. There is a special ledge on the stopper for removing it. Thus, it can be removed without additional assembly. The mandarin stiletto is thrown away after penetration and thus does not require care for its sterility.

Tests of the effectiveness of the device for intraosseous access were carried out on the corpses of adults of both sexes. As the access points, the head of the humerus and tuberosity of the tibia (zones of the thin cortical plate of the bone) were used. Using the trocar end of the mandrel-stylet, the skin and other soft tissue formations were perforated unhindered to contact with the bone. Following this, pressing the handle, made rotational movements in the direction and counterclockwise.

Moreover, in all cases, after 3-5 seconds, the cortical plate of the bone was penetrated and the needle was completely immersed in the spongy substance of the bone. After removing the styrene mandrel, it becomes possible to connect an infusion system or syringe to the cannula needle.

Claims (1)

A device for intraosseous access, consisting of a handle with a mandrel stylet, a stopper connection with a needle attached to it, characterized in that the needle in the stopper connection has a nozzle into which it is installed by mechanical expansion, the sharpening angles of the mandrel stylet and the needle are 48 ° + -15 'and 22 ° + -15', and the mandrel-stylet handle is made of two parts connected by a threaded connection - cylindrical and mushroom-shaped.

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