RU197792U1 - Intraosseous access device - Google Patents

Abstract

The device relates to medical equipment and can be used to inject drugs directly into the bone. The device for intraosseous access consists of a handle with a mandrel stylet, a stopper connection with a needle attached to it, while the handle is made of two parts connected by a threaded connection - cylindrical and mushroom-shaped. The technical result is a reduction in the material consumption of manufacturing.

Description

The device relates to medical equipment, and in particular to devices for administering drugs through intraosseous access during emergency medical care in emergency situations.

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%).

For the first time, the intraosseous space was considered as a non-decaying component of the circulatory bed in 1922. C. Drinker, a doctor from Harvard University, examined the blood circulation in the sternum and concluded that the solution introduced into the bone marrow was rapidly absorbed into the central vascular bed, providing an opportunity for vascular access, when traditional methods of infusion are not applicable. In 1936, Tocantis and O’Neill found that when 5 ml of saline was injected into the rabbit’s long bone, only 2 ml were at the distal end. Thus, the authors concluded that the physiological solution passed the systemic circulation. Subsequent studies confirming the intraosseous absorption of the fluid included the injection of the dye into the medullary cavity, after which, within 10 seconds, the dye reached the heart. Later, an intrasternal injection method was developed, which was widely used during the Second World War. During the war, the U.S. military documented more than 4,000 cases of intraosseous infusion, which has become an integral part of standard practice for treating seriously wounded soldiers. However, the practice of using VK infusion was lost in the postwar years.

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 intraosseous 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 5 seconds, which is extremely important when providing emergency medical care and intensive care.

Currently, intraosseous access is recommended as an alternative (backup) route of administration of pharmacological agents for any critical conditions requiring emergency initiation of drug and infusion therapy, if traditional intravenous access is difficult or impossible.

The generally accepted algorithm of intensive care and cardiopulmonary resuscitation requires the immediate use of intraosseous access if it is impossible to catheterize the peripheral or central vein within 60 seconds or after 2 unsuccessful attempts, and in pediatric practice, intraosseous access even acts as a priority.

The advantages of intraosseous access include the possibility of providing it in adults and children from the first attempt in 92-96%, and during the first minute.

To prevent the development of pain in patients in consciousness, intraosseous administration of a 1-2% lidocaine solution is recommended. Lidocaine is administered at a dose of 0.5 mg / kg for 2 minutes after an aspiration test and again at a dose of 0.25 mg / kg for 2 minutes after an injection test.

Thus, the use of the method of intraosseous administration of pharmacological drugs is justified when it is difficult to ensure traditional intravenous access, especially in the pre-hospital stage.

The documented overall complication rate associated with intraosseous access is less than 1%. Potential complications include extravasation (leakage), needle displacement, compartment syndrome (increased subfascial pressure), fracture, pain associated with infusion or drug / fluid administration, and infection.

A common experience with catheter placement in thousands of children and adults shows that the infection rate is less than 0.6%. Complications are often not too serious and can be treated outside the hospital. The VC access setup for adults is well documented in restless patients. Studies have shown that the installation is well tolerated and at the same time no more painful than the installation of a peripheral IV catheter of large diameter. Restless patients report pain after installing VK access. The pain associated with the initial administration of fluid or drugs arises from excessive pressure on the nerve fibers located in the bone marrow space. Initial bolus administration of lidocaine or novocaine solutions effectively relieves discomfort.

It is not advisable to leave the catheter for more than 4-6 hours. After 72 hours, the needle must be removed.

Intraosseous access is currently recommended as the first alternative to intravenous access in patients with cardiac arrest. intraosseous access is recognized as a safe and effective way of access to the central bloodstream. Intraosseous access is the standard of care for patients with cardiac arrest. Intraosseous access is equivalent to a central venous catheter and has a lower risk of complications when doctors use emergency care. Intraosseous access in an adult patient is safe and effective, according to several studies in the guidelines, intraosseous access should be established if intravenous access cannot be established. Intraosseous administration of drugs is preferable to endotracheal administration, as it provides a more predictable effect of the drugs and pharmacological effect. According to protocols and algorithms, intraosseous and intravenous access are well combined and are recommended for drug administration compared to the central catheter and endotracheal method in patients with cardiac arrest. When using intraosseous access, fluids and drugs reach the central bloodstream in a few seconds.

The device for intraosseous access is included in the regulation 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 and kits for emergency medical care. ”However, only imported devices are found on the Russian medical market.

Intraosseous (intraossal) access, capable of providing fast, safe, non-falling access to the vascular system, has several advantages over intravenous in many situations of emergency medical care.

On the other hand, intraosseous access has certain features that make it difficult to use, and also require the operator to have certain specific skills and experience when entering a working tool of the corresponding functional purpose. So, in particular, one of the main difficulties with intraosseous access, when an intraosseous needle is used as a working tool, is the incorrect location of the access point. This difficulty is easily overcome by mastering a practical skill on an appropriate training simulator.

A device for intraosseous infusion of drugs in the absence of vascular access to provide emergency medical care to victims regardless of their age.

In a device including a mounting assembly, a needle assembly, an impact assembly, and a safety assembly, according to a utility model, a groove for locating the ball retainer is formed at the distal end of the hammer assembly. [RU 193231 U1 10/18/2019].

The disadvantages of the device include the complexity of its manufacture.

A device for intraosseous infusion containing a battery device and a trocar, which is represented by a catheter and stylet, a trocar and a battery device are tightly connected by adapting the shaft tip of the said battery device and a docking groove of the stylet, at the bottom of which a magnet is made, and the stylet and catheter are tightly connected by adapting the grooves and protrusions of their docking parts, moreover flush magnets are made on the protrusions of the connecting part of the catheter and in the grooves of the connecting part of the stylet [RU, 195 027, U1].

The disadvantage of this device is its complexity, due to the fact that you need a power source, charge control and battery pack changes.

Known cordless electric drill EZ-IO with a set of needles [US 2016183974 A1, 06/30/2016]. A node is configured to provide access to the cancellous bone. May include an external penetrator and a removable internal trocar capable of penetrating the bone. The removable inner trocar may include a groove adapted to receive a portion of the bone when the external penetrator and the removable internal trocar penetrate the bone. The removable inner trocar may include a socket configured to receive a portion of the connector configured to detachably connect the penetrator assembly to the actuated device, and a trip mechanism located within the socket and operable to engage with the connector portion.

The disadvantage of this device is its complexity, due to the fact that you need an external power source, charge control and battery pack changes.

A well-known analogue is the Israeli single-shot pistol Bone Ingection Gun [http://ps-med.com/products/vascular/BIG-RSYS-A]. The syringe gun is made in the form of a plastic cylinder with an extension under the hand grip with a spring-trigger mechanism inside. A metal needle with an integrated channel is hidden inside the protective case. It is used for shock perforation of the bone and the possibility of intraosseous infusion. When the handle is pressed, the percussion mechanism is triggered, and the needle hidden inside it “shoots out”, breaking through soft tissue and penetrating the bone. The needle is so strong that it easily enters the bone (into the medulla). Having pulled out the plug, the needle is used as a channel for introducing the necessary fluids and medicines into the body of the victim. They instantly enter the body, thereby removing the wounded from a critical situation.

The disadvantage of this device is the complexity of manufacturing. In addition, when firing a shot, the initial impulse given to the needle by the spring is always the same, being set by the manufacturer in the manufacture of the device. Moreover, if the needle goes too far in the soft tissues and / or the bone density is higher than a certain “standard” value, the needle loses the momentum necessary for penetration into the bone tissue, and as a result the needle may not enter the bone tissue to the desired depth or do not penetrate bone tissue at all. Moreover, with an insufficient penetration rate, the needle does not create an exact hole, but instead breaks the bone tissue, which subsequently causes the needle to not fix in the tissues and loss of intraosseous access.

On the other hand, too much impulse transmitted to the needle can cause severe tissue injury when the needle enters too deep. It should also be borne in mind that, once started, the “shot” process is no longer controlled by the operator, which, if the patient’s position is difficult, for example, is difficult to see, is difficult to insert, the tool may not be accurately positioned by the operator, the “shot” will occur in the wrong direction full penetration depth and severe tissue injury will occur.

Finally, the “loading” of such devices with a new needle is practically impossible in the field, as a result, most existing devices are disposable, which, with a sufficiently high technical complexity of such devices, leads to a significant increase in the cost of the procedure, the large occupied space in the medical installation, if necessary, have several devices to assist multiple patients.

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

Known intraosseous needle "Cook 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 emergencies. Products are supplied 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.

The intraosseous needle Cook Intraosseous Needle is intended for children to 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.

EFFECT: reduced material consumption of manufacturing.

The technical result is achieved by a device for intraosseous access, consisting of a handle with a mandrin stylet, a stopper connection with a needle attached to it, characterized in that the handle is made of two parts connected by a threaded connection - cylindrical and mushroom-shaped.

Material consumption - one of the main indicators of the economic efficiency of production, material consumption characterizes the specific (per unit of production) consumption of material resources (basic and auxiliary materials, fuel, energy, depreciation of fixed assets) for the manufacture of products. Material consumption can be measured in value and in kind. The material consumption indicator is used in the analysis of the production and economic activities of metallurgical enterprises, in particular, the cost of production with an average comparison (resource saving) of unit costs for various types of metal products, including for the main metallurgical redistributions (smelting of iron, production of steel, rolled products, etc.), as well as the establishment of optimal prices for new products, etc. Material consumption is calculated according to the norms (standard value Mn) or according to actual data (facts, value Mf). The excess of MF over Mn reserves of reducing material consumption. The main ways to reduce material consumption are enrichment and integrated use of raw materials, increasing the technical level of production (based on new equipment and technologies), reducing production waste, etc.

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 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.

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

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 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 loosening 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 direction.

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.

Studies have shown that the implementation of the handle of two parts connected by a threaded connection - cylindrical and mushroom-shaped can significantly reduce material consumption in the manufacture. In the prototype, 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 the proposed technical solution, material consumption is significantly reduced due to the fact that the lower part is manufactured separately and screwed to the upper. 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. In the proposed case, the material consumption and the complexity are reduced due to the fact that there is no need to paint the lower part.

Claims (1)

An intraosseous access device, consisting of a handle with a mandrel stylet, a stopper connection with a needle attached to it, characterized in that the mandrel stylet handle is made of two parts connected by a threaded connection - cylindrical and mushroom-shaped.

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