RU2240151C1 - Device for draining intracranial cavities - Google Patents

Abstract

FIELD: medical engineering.

SUBSTANCE: device has flexible proximal tube having lateral openings at one end, hollow connection member having two openings and flexible distal tube. The distal tube is designed as reservoir open on both ends. Connection member openings are connected to the distal tube. The proximal tube has an adapter allowing the angle of tube bending to be varied. The adapter has collars put on over the proximal tube and thread brought through the collars tightened for changing tube angle by varying distance between the collars. The reservoir has cylindrical shape with diameter being greater than that of the proximal tube and is hatched.

EFFECT: enhanced effectiveness of treatment; reduced risk of traumatic complications; simplified design.

5 cl, 4 dwg

Description

The invention relates to medicine and can be used in neurosurgery for prolonged drainage of intracranial cavities containing fluid (for example, cysts, chronic hematomas, hygroma, isolated fragments of the ventricles of the brain, etc.).

A device for long-term drainage of intracranial cavities containing fluid, which is made in the form of a catheter connected to the reservoir. A catheter is inserted into the drained cavity, and the reservoir is placed under the soft tissues of the head. The liquid that accumulates in the tank is removed with a needle, which must be repeatedly inserted into the tank, while also piercing the soft tissues located above it. An example is a Ventricular Catheter connected to an Ommaya CSF Reservoirs [1].

This device has several disadvantages:

- there is no constant outflow of fluid from the drained area;

- significant fluctuations in intracranial pressure occur;

- high risk of infectious complications due to numerous piercing of the reservoir;

- loss of biologically important substances along with drained fluid;

- the possibility of drainage only by specialists.

A known method [2], in which a device for long-term drainage of intracranial cavities containing fluid, consists of: a catheter inserted into the drained cavity (for example, a ventricular catheter); a reservoir connected to the catheter (for example, a counter-flex valve) located under the soft tissues of the head; a long distal tube (peritoneal catheter) that drains the fluid from the reservoir into the internal cavity of the body located outside the head, where the fluid is absorbed (for example, into the abdominal cavity); a valve located in the reservoir or in the distal tube and designed to maintain a certain pressure in the drainage cavity. When this drainage is carried out by the outflow of fluid from the drained cavity into the cavity, where it is absorbed at a pressure higher than the pressure that opens the valve of the device.

The disadvantages of this method:

- drainage is possible only when the viscosity of the drained fluid is low, otherwise the patency of the slit-like openings of the valve is impaired and drainage ceases;

- the installation of such a device is traumatic because it requires the formation of a long subcutaneous tunnel from the head to the abdominal wall, as well as opening the abdominal cavity for implantation of the abdominal end of the distal catheter into the abdominal cavity;

- the device is complex in design and very expensive (up to $ 1,000);

- to temporarily stop and then restore drainage, if necessary, two additional surgeries are required, which significantly increases the risk of complications that are dangerous to the life of the child;

- given the high profile of the reservoir and the inability to move it under the skin, trophic skin disorders are possible above it with a subsequent purulent process, which excludes the possibility of installing this device in infants weighing less than 2 kg.

Closest to the proposed device is a device [3] for prolonged drainage of intracranial cavities containing fluid (figure 2), consisting of an elastic proximal tube 1, a rigid connector 2 and an elastic distal tube 3. Moreover, the proximal and distal tubes have the same diameter (2 -3 mm), the rigid connector 2 is made in the form of a tube bent at a right angle, the diameter of which corresponds to the inner diameter of the proximal and distal tubes. At one end, the distal and proximal tubes are fixed on opposite ends of the connector 2, the other end of the proximal tube is provided with multiple side openings 4 and lowered into the intracranial cavity, and the second end 5 is closed at the distal tube, and a side slit valve 6 is made in the immediate vicinity of it.

The device is used as follows. Soft tissues are dissected at a selected point in the head, the skin and aponeurosis (galea aponevrotica) peel off from the underlying periosteum for a considerable length, thus forming an artificial cavity that can absorb fluid (subgaleal pocket). In the area of the skin incision in the bone, a hole is drilled through which the proximal tube 1 of the device is inserted into the intracranial cavity containing the fluid, its end in the area of the bone hole is connected to the corner connector 2, to the other end of which the distal tube is connected. Its free end is located in the region of the subgaleal pocket. Connector 2 is fixed with a suture to the periosteum in the area of the opening in the bones of the skull.

The device operates as follows. Fluid from the intracranial cavity flows through the proximal tube located in it into the corner connector and the distal tube, from where it enters the subgaleal pocket, where it is absorbed by the soft tissues that make up the walls of this pocket. Unidirectional fluid flow is formed by pressure in the cavity, which exceeds the pressure of the opening valve of the distal tube and the pressure of the liquid in the cavity of the subgaleal pocket. As the fluid is sucked in, the pressure in the subgaleal pocket decreases, the valve opens, and the next portion of the fluid flows from the intracranial cavity into the pocket.

This device also has several disadvantages:

- a high risk of tube obstruction with increased viscosity of the liquid and in the presence of substances capable of precipitating in the liquid, the most unfavorable conditions in this regard are in the area of the slit-like valve;

- it is impossible to get the liquid directly from the drained cavity for analysis, only the contents of the subgaleal pocket are easily accessible, however, it often differs significantly from the liquid that is in the cavity;

- it is impossible to inject medications directly into the cavity from which the fluid flows, if such a need arises (for example, drugs that accelerate the resorption of blood bundles with intraventricular hemorrhage in newborns);

- to restore the patency of the tubes requires additional surgery, which increases the risk of inflammatory changes that are dangerous to the life of the child;

- the removal of the device is quite long, traumatic, and is associated with an increased risk of loss of the proximal tube in the cranial cavity, since the angular adapter and the tubes attached to it during prolonged exposure to the body are overgrown with scar tissue, to remove them, the adapter and the junction of the tubes must be selected from the scars the incision should be made in the area of the bone opening, which, among other things, increases the risk of the contents of the cavity flowing out through the seams, since there is a very short path between the seams and the cavity (the longer this path, the lower the risk of fluid leakage through postoperative sutures);

- if there is a temporary lack of fluid in the pocket (for example, a decrease in pressure in the cavity), the walls of the pocket may stick together and significantly reduce its volume, the need to restore its size requires a second operation that increases the risk of inflammatory changes that are dangerous for the child’s life;

- Slit-shaped tubes and adapters are manufactured in a few foreign countries, so a drainage device costs about $ 100;

- the bending angle of the device can only be straight (an angular adapter is a tube bent at a right angle), which does not take into account the variety of optimal angles depending on the size of the child’s head and the localization of the intracranial cavity; this is especially true for newborns and the drainage of subdural hematomas in children of various age groups;

- at low pressure in the intracranial cavity, their outflow ceases, which eliminates the possibility of complete emptying of a number of intracranial cavities, for which a gradual decrease in pressure in them is almost zero (for example, in the cavity of chronic intracerebral hematomas).

All these shortcomings significantly limit the possibility of widespread practical use of long-term drainage of intracranial cavities containing fluid, especially in newborns.

The aim of the invention is to increase efficiency, reduce trauma, as well as simplify the design of the device for drainage of intracranial cavities containing fluid.

This goal is achieved by the fact that in the device for drainage of intracranial cavities, consisting of an elastic proximal tube with multiple side holes at one end, a hollow connector with two holes and an elastic distal tube, the distal tube is made in the form of a tank with notches open at both ends, the holes of the connector are coaxial, but have different diameters, the hole of a larger diameter being connected to the distal tube, and the proximal tube is equipped with an adapter that Fitted with the ability to change the bending angle of the tube.

In addition, the adapter can be made in the form of cuffs worn on a proximal tube with thread threaded through the cuffs, and the reservoir can be cylindrical in diameter with a diameter exceeding the diameter of the proximal tube and have at one end of the notch the entire thickness of the tube wall, reaching up to its edges.

The inventive device for drainage of intracranial cavities is presented in the drawings, which show:

figure 1 - General view of the device;

figure 2 - position of the catheter with a changed angle;

figure 3 - the position of the device on the head of the patient.

The device (Fig. 1) contains an elastic proximal tube 1 with multiple side holes 4 at one end, a distal tube in the form of a reservoir 3, a rigid connector 2 and an angular adapter, which consists of cuffs 5 and a thread 6 passed through them. Connector 2 has coaxial holes of different diameters. The proximal tube 1 is attached to its smaller hole, and the larger hole is connected to the reservoir 3. The cuffs 5 of the angular adapter are worn on the proximal tube 1. The angle of the adapter is changed by tensioning the thread 6 connecting the cuffs 5.

The reservoir 3 may have a cylindrical shape and may be provided with notches 7, made, for example, in the form of through end cuts in the walls of the reservoir from one of its sides. Both ends of the reservoir are open, the diameter of both end holes corresponding to the inner diameter of the distal tube, called the reservoir.

Figure 2 shows the possibility of changing the bending angle of the proximal tube from acute (A) to blunt (B). A change in the angle occurs when tightening the thread 6, passed through the cuff 5 (see designations in figure 1). After reaching the desired bending angle of the tube, the thread is tied to a knot. Change the angle as follows. The tighter the thread is stretched, the closer the cuffs of the angular adapter are to each other and the more the proximal tube bends. Moreover, its internal diameter at the bend changes slightly. To reduce the bending angle, you need to untie the thread and loosen its tension, then again tie the thread in a knot.

The device is used as follows (figure 3). Soft tissues 8 are dissected at a selected point in the head, the skin and aponeurosis 9 (galea aponevrotica) 9 peel off from the underlying periosteum and bone 10 for a considerable length, thus creating an artificially formed cavity 11 that can absorb fluid (subgaleal pocket). A hole 3 mm in diameter is drilled in the area of the skin incision in the bone. A wire conductor is inserted inside the assembled device, which adds rigidity to the device. The proximal tube 1 through the hole in the bone is inserted into the lumen of the intracranial cavity 72, three cuffs 5 of the angular adapter are installed so that the lower one is in the bone hole, and the rest are higher than this cuff (at a distance of 1-2 mm from each other). The wire conductor is removed. The device becomes elastic.

The reservoir 3 is placed in a subgaleal pocket, and the thread is stitched through the periosteum in the area of the bone opening and tied to a knot. At the same time, the device is fixed to the periosteum and a bend of the proximal tube 1 is formed at the required angle (figure 2). After this, the wound is sutured.

Through the device, the fluid enters the pocket 11, where it is absorbed by the surrounding soft tissues of the head and neck. If the suction rate is insufficient, periodic pocket punctures and fluid removal are performed. The tank is groped well through the skin. Periodically moving it in the cavity of the pocket, prevent the adhesion of its walls. To obtain fluid directly from the intracranial cavity or the need for medication to be injected into it, the reservoir is punctured with a needle, and its free edge is temporarily closed by pressing a finger on the skin above the opposite end of the reservoir. The presence of notches on the reservoir makes it possible to overlap its lumen with minimal pressure, which is especially important in newborns in whom the bones of the skull are very mobile and any excessive pressure can lead to displacement of the bones of the skull and brain injury. Thus, the hole connecting the tank with the pocket is temporarily closed, and the message with the drained cavity remains free. If the proximal tube is impaired, it is rinsed in the same way with a puncture of the reservoir.

After treatment, the device is removed through an additional incision away from the first incision. T.O. the risk of fluid leakage through postoperative sutures is reduced. Moreover, the incision is very small, the device is easily removed, since a smooth tube is located in the bone hole, and not a rigid rectangular connector with two tubes attached to it, the angular adapter straightens when pulling the reservoir, which greatly simplifies the removal of the device.

The advantages of the proposed device are:

- low risk of tube obstruction under conditions when the liquid contains various substances that can precipitate or with increased viscosity of the liquid (the absence of a slit-like valve and a distal tube of small diameter), and

- the ability to flush the device through the tank;

- the ability to obtain a fluid analysis directly from the cavity from which it is diverted;

- the possibility of introducing directly into the cavity from which the fluid flows, medications (for example, drugs that accelerate the resorption of blood bundles with intraventricular hemorrhage in newborns);

- reducing the risk of inflammatory changes associated with repeated operations aimed at restoring the patency of the device;

- simplification of the removal process of the device, reducing the risk of loss of the proximal tube in the cranial cavity while reducing trauma (the angular rigid connector has been replaced with a soft simulated adapter);

- reducing the risk of fluid leakage through postoperative sutures, since the device is removed through an additional incision;

- in the event of a temporary lack of fluid in the pocket (for example, a decrease in pressure in the cavity), the adhesion of the walls of the pocket is prevented by repeated movements of the reservoir in the cavity of the pocket;

- ease of manufacture of the device;

- the bending angle of the device can be any and depends on the specific conditions during the operation (this is especially important in newborns and drainage of subdural hematomas in children of various age groups);

- at low pressure in the intracranial cavity, the outflow from it does not stop, which excludes the possibility of incomplete emptying of the intracranial cavities, for which a gradual decrease in pressure in them is almost zero (for example, in the cavity of chronic intracerebral hematomas).

Thus, the claimed device is easier to manufacture (no complex valves), more technologically advanced, does not require expensive parts, which can significantly reduce the cost of the product. The device is also more convenient in operation, provides more efficient and less traumatic drainage than known devices of a similar purpose.

List of references

1. Neurosurgery Shunting Products. - Saba Medical Group, 1995. - C.24, P.34.

2. Information from the medical company OMB about shunt systems. - P.12.

3. Continuing Experirns with Subgaleal Shunting / M.H. Savitz, L.I. Malis - The Mount Sinai Journal of Medicine. - 2000, Vol. 67, No. 4. - P. 322-326.

Claims (5)

1. Device for draining intracranial cavities, consisting of an elastic proximal tube with side holes at one end, a hollow connector with two holes and an elastic distal tube, characterized in that the distal tube is made in the form of a reservoir open at both ends, the holes of the connector are made coaxial but have different diameters, with a larger diameter hole connected to the distal tube, and the proximal tube is equipped with an adapter that is capable of changing the bending angle t ubki. 2. The device according to claim 1, characterized in that the adapter contains cuffs worn on the proximal tube and a thread threaded through the cuffs with the possibility of tightening to change the angle of the tube by changing the distance between the cuffs. 3. The device according to claims 1 and 2, characterized in that the reservoir has a cylindrical shape, the diameter of which exceeds the diameter of the proximal tube. 4. The device according to claim 1 or 2, characterized in that the tank is equipped with notches. 5. The device according to claim 3, characterized in that the tank is equipped with notches.

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