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Title:
VENTRICULO-PERITONEAL SHUNT FOR HYDROCEPHALY PATIENTS
Document Type and Number:
WIPO Patent Application WO/2019/066749
Kind Code:
A2
Abstract:
The present invention relates to a ventriculo-peritoneal shunt (1) for hydrocephaly patients comprising ventricular end (2), one or more than one bore (2a) provided on the ventricular end (2) and which provides transfer of the liquid existing in the ventricle into the ventricular end (2). The ventriculo-peritoneal shunt (1) is characterized by comprising one or more than one bulge (2b) having slippery surface which provides sliding of ventricular end (2) on the structures existing in the ventricle and positioned in the vicinity of said bores (2a) and which provides prevention of contact of the bores (2a) to the structures existing inside the ventricle.

Inventors:
YAVUZ SELIN (TR)
Application Number:
PCT/TR2018/050222
Publication Date:
April 04, 2019
Filing Date:
May 11, 2018
Export Citation:
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Assignee:
YAVUZ SELIN (TR)
International Classes:
A61M25/00
Attorney, Agent or Firm:
KAYA, Erdem (TR)
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Claims:
CLAIMS

A ventriculo-peritoneal shunt (1 ) for hydrocephaly patients comprising ventricular end (2), one or more than one bore (2a) provided on the ventricular end (2) and which provides transfer of the liquid existing in the ventricle into the ventricular end (2), characterized by comprising:

one or more than one bulge (2b) having slippery surface which provides sliding of ventricular end (2) on the structures existing in the ventricle and positioned in the vicinity of said bores (2a) and which provides prevention of contact of the bores (2a) to the structures existing inside the ventricle.

A ventriculo-peritoneal shunt (1 ) according to claim 1 , characterized by comprising:

- one or more than one septum (2c) which provides separation of the front section of the ventricular end (1 ) into two or more chambers which provide separate liquid flow therein

- one or more than one bore (2a) in each of said chambers.

A ventriculo-peritoneal shunt (1 ) according to claim 1 , characterized by comprising:

- a heading (2d) provided on the ventricle end (2) and which provides guidance of the ventricle end (2) towards the upper side of the ventricle since it is made of a material which has a specific weight which is lower than the specific weight of the liquid existing in the ventricle.

A ventriculo-peritoneal shunt (1 ) according to claim 1 , characterized by comprising:

- a first valve (3) which provides control of the liquid output through the ventricle and which is opened when the pressure of the liquid, existing in the ventricle, increases over a specific level,

- a chamber (4) positioned before the first valve (3) and which has a baffle surface (4a) which prevents reaching of the pulsatile liquid pressures to the first valve (3) through the ventricle and having one or more than one gap (4b) which provides guidance of the liquid flow towards the first valve (3).

A ventriculo-peritoneal shunt (1 ) according to claim 1 , characterized by comprising:

- a reservoir (5) wherein at least some section of the liquid coming through the ventricle is stored and which is made of a material permitting detection of the level of the liquid stored therein by means of ultrasound, - a discharge path (6) which provides passage of the other section of the liquid, coming through the ventricle, without contacting reservoir (5),

- a second valve (7) which provides control of output of liquid stored in the reservoir (5) and which is opened when the liquid pressure, accumulated in the reservoir (5), increases over a specific level and having anti-siphon characteristic, a distal end (8) which provides transfer of the liquid, coming from the second valve (7) and the liquid coming from the discharge path (6), into the abdomen.

6. A ventriculo-peritoneal shunt (1 ) according to claim 1 , characterized by comprising:

- a distal end (8) which provides transfer of the liquid, coming through the ventricle, into the abdomen,

- a distal end apparatus (9) provided at the final section of the distal end (8) and which provides transfer of the liquid into the abdomen and having a slippery and round surface (9a).

7. A ventriculo-peritoneal shunt (1 ) according to claim 6, characterized by comprising:

- a mechanism (9b) provided in the distal end apparatus (9) and which provides prevention of the back-flow of the other structures into the distal end (8). 8. A ventriculo-peritoneal shunt (1 ) according to claim 7, characterized in that:

- said mechanism (9b) comprises duck-billed valve (9b-1 ) and/or membrane (9b-2) which provide(s) prevention of back-flow of the liquid, existing in the abdomen, into the distal end (8). 9. A ventriculo-peritoneal shunt (1 ) according to claim 1 , characterized by comprising:

- removable/fixable sections.

10. A ventriculo-peritoneal shunt (1 ) according to claim 9, characterized by comprising:

- an additional part fixed between removable/fixable sections and which provides extending of said ventriculo-peritoneal shunt (1 ).

11. A ventriculo-peritoneal shunt (1 ) according to claim 9, characterized by comprising:

- a removable/fixable first valve (3). 12. A ventriculo-peritoneal shunt (1 ) according to claim 9, characterized by comprising:

- a removable/fixable second valve (7).

13. A ventriculo-peritoneal shunt (1 ) according to claim 9, characterized by comprising: - a distal end apparatus (9) removable/fixable from/to the distal end (8).

14. A ventriculo-peritoneal shunt (1 ) according to claim 10, characterized by comprising:

- an additional part fixed between the distal end (8) and the distal end apparatus (9) and which permits extending of said ventriculo-peritoneal shunt (1 ).

Description:
VENTRICULO-PERITONEAL SHUNT FOR HYDROCEPHALY PATIENTS TECHNICAL FIELD

The present invention relates to tools known as "ventriculo-peritoneal shunt" which provides transfer of liquid into the abdomen (peritoneum) in order to reduce liquid pressure in the ventricles inside the brain in case said pressure increases.

KNOWN STATE OF THE ART

Ventricle describes the chamber inside the brain and peritoneum describes the inner section of the abdomen. Said tool realizes its function by transferring the excessive liquid inside the ventricles into the peritoneum. The peritoneum suctions said liquid and transfers said liquid to the body. Thus, the ventriculo-peritoneal shunt can be used for decreasing the liquid pressure inside the brain in all cases which lead to hydrocephaly (increase of liquid pressure in the ventricles inside the brain) disease, for instance tumors, cerebral bleedings, congenital anomalies.

In Figure 1 , a ventriculo-peritoneal shunt (1 ') known from the present applications is shown. Ventriculo-peritoneal shunt (1 ') comprises three sections. These sections are respectively a ventricular end (1 '), a valve (3') and a peritoneal end (distal end) (8'). The tubular ventricular end (2') enters into the ventricles inside the brain and receives the liquid therein through the bores. The liquid entering through said ventricular end (2') is transferred to the valve (3'). The valve (3') arranges liquid output from the brain. For example, if the valve (3') opens at the pressures above 30 mmHg, it permits liquid flow when the pressure increases over this value. The liquid, passing through the valve (3'), advances to the distal end (8'). The tubular distal end (8') transfers the liquid into the abdomen.

When the ventriculo-peritoneal shunts (1 ') known from the present applications are used, in the first year, 40% of them malfunctions, in the second year, 50% of them malfunctions and in the tenth year, 70% of them malfunctions. The reasons of deteriorations of the functions of said ventriculo-peritoneal shunts (1 ') can be classified as follows:

Ventricular end blockage: In the ventriculo-peritoneal shunts (1 ') known from the present applications, the most frequent complication reason is blockage in the ventricular end (2'). The sponge-like structure, named as "choroid plexus" in the ventricle, produces the liquid inside the ventricle, and at the same time, it is the structure which leads to blockage of the ventricular end (2') inside the brain. Distal end (8) blockage: The organs and structures in the abdomen may lead to blockage of the distal end (8'). According to an event recorded in the literature, an intestine tapeworm may lead to blockage of the distal end (8).

Infection : In addition to the blockage of ventricular end (2') inside the brain, the distal end (8') blockage inside the abdomen and the excessive liquid output from the brain, infection may also occur. At the same time, the ventricular end (2') may damage the structures around it due to its tubular structure and may lead to infections. Moreover, for example, when the bacteria in the intestine pass through the distal end (8'), they may lead to infection. Due to the liquid stasis in the distal end, infection formation risk increases. All of the surgeries being realized bear more risk depending on the size of said surgery and increase infection risk.

Slit ventricle syndrome (excessive liquid output from the brain): The valve (3'), which is normally a part of the ventriculo-peritoneal shunts (1 '), opens when the liquid pressure inside the ventricle increases and liquid passage occurs. However, when the patient becomes excited or when the heart beating power of the patient increases in any case, these pressures reflect to the liquid inside the brain and they reflect to the valve (3') from there. The opened valve (3') leads to liquid output from the brain. In case of such excitability conditions, even when the liquid amount in the brain does not increase, liquid output may unnecessarily occur which leads to damage in the brain.

Insufficient ventriculo-peritoneal shunt (1 ') length: When the height of the patients grows, the length of the ventriculo-peritoneal shunt which has been fixed beforehand is insufficient. For example, the ventriculo-peritoneal shunt (1 ') fixed to a child with a height of 60 cm has a length of 30 cm. When said child has a height of 120 cm, the length of the ventriculo- peritoneal shunt (1 ') shall be 50 cm. In this case, since the height of the child naturally increases, the child shall undergo surgery again.

As a result, because of the need for sustaining of the functions of the ventriculo-peritoneal shunt without complication and the insufficiency of the present solutions, an improvement is required in the related technical field. OBJECT OF THE INVENTION

The present invention relates to a ventriculo-peritoneal shunt, for eliminating the above mentioned disadvantages and for bringing new advantages to the related technical field.

The main object of the present invention is to provide a ventriculo-peritoneal shunt where at least some of the abovementioned syndromes in hydrocephaly patients can be prevented.

In order to realize the abovementioned object, the subject matter ventriculo-peritoneal shunt is characterized by comprising one or more than one bulge having slippery surface which provides sliding of ventricular end on the structures existing in the ventricle and positioned in the vicinity of said bores and which provides prevention of direct contact of the bores to the structures existing inside the ventricle. Thanks to the subject matter ventriculo-peritoneal shunt, the blockage complications frequently faced are prevented and the number of surgeries for preventing blockage complications is reduced. Thanks to the subject matter ventriculo-peritoneal shunt, since blockage can be prevented, the infections dependent on this can also be prevented. Thanks to the subject matter ventriculo-peritoneal shunt, since the number and size of surgeries to be realized for preventing blockage can be decreased, the risk of infection resulting from surgeries can also be reduced.

The structural and characteristic properties and all advantages of the present invention are going to be understood in a clearer manner thanks to the figures given below and thanks to the detailed description written by means of referring to these figures, and therefore, the evaluation shall be made by taking into consideration these figures and the detailed description.

BRIEF DESCRIPTION OF THE FIGURES

The present invention is to be evaluated together with annexed figures briefly described hereunder to make clear the subject matter embodiments and the advantages thereof.

Figure 1 is the view of the ventriculo-peritoneal shunt of the known state of the art.

Figure 2 is the view of the ventriculo-peritoneal shunt in an embodiment of the present invention. Figure 3a is the external view of the ventricular end on the ventriculo-peritoneal shunt in an embodiment of the present invention.

Figure 3b is the schematic inner view of the ventricular end on the ventriculo-peritoneal shunt in an embodiment of the present invention.

Figure 4 is the inner view of chamber and first valve provided on the ventriculo-peritoneal shunt in an embodiment of the present invention. Figure 5a is the schematic inner view of the chamber and first valve provided on the ventriculo-peritoneal shunt in another embodiment of the present invention.

Figure 5b-5d are the schematic cross sectional views in the sections shown by I, II and III of the ventriculo-peritoneal shunt in Figure 5a in another embodiment of the present invention.

Figure 6a is the schematic inner view of the reservoir, discharge path and second valve provided on the ventriculo-peritoneal shunt in an embodiment of the present invention.

Figure 6b is the lateral schematic cross sectional view of the ventriculo-peritoneal shunt provided in Figure 6a in an embodiment of the present invention.

Figure 7a is the schematic inner view of the distal end apparatus provided on the ventriculo- peritoneal shunt in an embodiment of the present invention. Figure 7b is the schematic inner view of the distal end apparatus provided on the ventriculo- peritoneal shunt in another embodiment of the present invention.

Figure 8 is the view of notched/non-notched membranes and various duck-billed valves used in the distal end apparatus provided on the ventriculo-peritoneal shunt in another embodiment of the present invention.

Figure 9a-9c are the schematic views of the operation of the mechanism which prevents back-flow of liquid used in the distal end apparatus of ventriculo-peritoneal shunt in an embodiment of the present invention. REFERENCE NUMBERS

1 . Ventriculo-peritoneal shunt

2. Ventricular end

2a. Bores

2b. Bulge

2c. Septum

2d. Heading

3. First valve

4. Chamber

4a. Baffle surface

4b. Gap

5. Reservoir

6. Discharge path

7. Second valve

8. Distal end

9. Distal end apparatus

9a. Round surface

9b. Mechanism

9b-1 . Duck-billed valve

9b-2. Membrane

DETAILED DESCRIPTION OF THE INVENTION In this detailed description, the subject matter ventriculo-peritoneal shunt (1 ) is explained with references to examples without forming any restrictive effect only in order to make the subject more understandable.

In Figure 2, the general view of the ventriculo-peritoneal shunt (1 ) in an embodiment of the present invention is given. The subject matter ventriculo-peritoneal shunt (1 ) is suitable to be used for hydrocephaly patients. The sections of the ventriculo-peritoneal shunt (1 ) will be described in detail below.

As essentially shown in Figure 2, there is a ventricular end (2) on the ventriculo-peritoneal shunt (1 ). As shown in details in Figure 3a, on the ventricular end (2), there is one or more than one bore (2a) preferably in the form of arrays. By means of said bores (2), the liquid, existing in the ventricle, is transferred into the ventricular end (2). As shown in details in Figure 3a, on the ventricular end (2), there are bulges (2b) which are preferably made of silicon material. Said bulges (2b) have smooth slippery surfaces. Thanks to said slippery surfaces, the ventricular end (2) is slid on the structures existing in the ventricle. Moreover, the bulges (2b) are positioned in the vicinity of said bores (2a). The bores (2a) remain between the bulges (2b). Said bulges (2b) prevent contact of the bores (2a) to the structures inside the ventricle. Thanks to the subject matter bulges (2b), the contact of the ventricular end (2) to the formations existing in the ventricle is minimized and blockages can be prevented. As shown in details in Figure 3b, septum (2c) exist in the ventricular end (2). Said septum (2c) provide the front section of the ventricular end (1 ) to be separated into preferably four chambers (2, 3 or can be more in number) which provide separate liquid flow therein. Said bores (2b) are opened to each of said chambers. On each chamber, the bores (2b) and the bulges (2b) are preferably arranged in a single array in an alternate manner. In case of start of a probable blockage, as the flow in the blocked chamber of the ventricular end (2) decelerates, the balance of the ventricular end (2) is deteriorated and it begins movement and it is separated from the present location which leads to adhesion. Moreover, in case of a probable blockage, since the blockage in the blocked chamber will not spread to the other chambers and since said blockage will not have an effect, the ventricular end (2) can continue to sustain its function. Thanks to the subject matter septum (2c), the complications depending on ventricular end (2) blockage can be prevented. As shown in details in Figure 3b, there is a heading (2d) at the end section on the ventricular end (2). Since said heading (2d) is made of a material which has a specific weight which is lower than the specific weight of the liquid existing in the ventricle and since said heading (2d) is made of light silicon, the ventricle end (1 ) is guided to the upper side of the ventricle, in other words, it is guided towards the ceiling which is not choroid plexus. Thus, the ventricle can diverge from the blocking structures existing at the lateral sides. Said heading (2d) is preferably in the form of a ball which is full of silicon.

Thanks to the bulges (2b) and/or septum (2c) and/or heading (2d) provided in the subject matter ventricular end (1 ), blockages can be prevented and the blockage-based infections can also be prevented.

As essentially shown in Figure 2, on the ventriculo-peritoneal shunt (1 ), there is the first valve (3) and the chamber (4) which follow the ventricular end (2). As shown in details in Figure 4, liquid output through the ventricle is controlled by means of the first valve (3). When the pressure of the liquid inside the ventricle exceeds a specific level, the first valve (3) is opened. When the pressure of the liquid is under a specific level, the first valve (3) is closed. As shown in details in Figure 4, on the ventriculo-peritoneal shunt (1 ), the chamber (4) has been positioned before the first valve (3). Said chamber (4) has a baffle surface (4a) which prevents reaching of the pulsatile liquid pressures, existing in the ventricle, to the first valve

(3) . The baffle surface (4a) is preferably provided in the middle of the chamber (4) and it is before the valve (3). Moreover, said chamber (4) has gaps (4b) which provide guiding of the liquid flow towards the first valve (3). The gaps (4b) are preferably provided on the lateral sides of the baffle surface (4a). Thanks to said baffle surface (4a), the first valve (3) senses only the pressures depending on the increase of liquid, however, when the patient is excited, it is not affected by the pulsatile pressure increases resulting from heart beating power. By means of this, excessive liquid output from the brain is prevented and the patient can be protected from being harmed by the excessive liquid loss. Moreover, thanks to the anti- siphon characteristic of the first valve (3), the back-flow of liquid can be prevented when the patient stands up and when the patient is in lying position and the infection risk can be reduced. In Figure 5a, in another embodiment of the present invention, the schematic inner view of the chamber (4) and the first valve (3) existing on the ventriculo-peritoneal shunt (1 ) is given. In the figures between Figure 5b and 5d, the cross sectional views of the chamber

(4) in Figure 5a in the sections shown respectively by ", "II" and "I II" are given. As can be seen in the figures between Figure 5b and 5d, the liquid passes through the gaps (4b) on the lateral side of the baffle surface (4a) and reaches the first valve (3). As essentially shown in Figure 2, on the ventriculo-peritoneal shunt (1 ), after the first valve (3) and after the chamber (4) and before the distal end (8), there are the reservoir (5), the discharge path (6) and the second valve (7). The distal end (8) provides transfer of the liquid, coming through the ventricle, into the abdomen. As shown in details in Figure 6a and Figure 6b, at least some section of the liquid, coming through the ventricle, is stored in the reservoir (5). The other section of the liquid, coming through the ventricle, passes through the discharge path (6) without reaching the reservoir (5). As shown in details in Figure 6a, the output of the liquid stored in the reservoir (5) is controlled by the second valve (7) provided at the lower side. When the pressure of the liquid accumulated in the reservoir (5) exceeds a specific level, the second valve (7) is opened. When the pressure of the liquid is lower than a specific level, the second valve (7) is closed. Moreover, the second valve (7) has anti-siphon characteristic and it prevents back-flow of the liquid. As shown in details in Figure 6a, by means of the distal end (8), the liquid coming through the second valve (7) and the liquid coming through the discharge path (6) are transferred together into the abdomen. The reservoir (5) comprises an ultrasound permeable material. The level of the liquid stored in the reservoir (5) can be detected by means of ultrasound. The first advantage provided by the reservoir (5) and the second valve (7) will be explained below. For example, let us assume that the liquid level inside the reservoir (5) is for instance 2 mm in the first observation and it is for instance 4 mm in the second observation. By means of this method, it is simply shown that the sections of the ventriculo-peritoneal shunt (1 ) before the reservoir (5) work well. In a similar manner, let us assume that the liquid level inside the ventriculo-peritoneal shunt (1 ) is for instance 5 mm in the first observation and it is for instance 3 mm in the second observation. This shows that the liquid have reached the distal end (8). By means of this, an easy and simple interpretation is provided for the blockages with the help of ultrasound. Another advantage provided by the reservoir (5) and the second valve (7) will be explained below. In the standard ventriculo-peritoneal shunts (1 ) shown essentially in Figure 1 , while the patient stands up, there is a pressure difference between the distal end (8') in the abdomen and the valve (3') at the head level. This pressure difference may lead to undesired output of the liquid inside the ventricle. In the subject matter ventriculo-peritoneal shunt (1 ), the reservoir (5) functions as an intermediate chamber, it minimizes the pressure difference which may affect the first valve (3) which is close to the ventricular end (1 ). Another advantage provided by the discharge path (6) will be explained below. When the patient is in lying position, the liquid will pass through the discharge path (6) and it will be transferred towards the distal end (8).

As essentially shown in Figure 2, there is a distal end apparatus (9) at the final section of the distal end (8) on the ventriculo-peritoneal shunt (1 ). The distal end apparatus (9) provides the liquid to be transferred into the abdomen. In Figure 7a and 7b, in different embodiments of the present invention, the detailed inner views of the distal end apparatus (9) are given. As shown in details in Figure 7a and 7b, the distal end apparatus (9) has a smooth slippery and round surface (9a). Thanks to the smooth, slippery and round surface (9) of the distal end apparatus (9), the distal end apparatus (9) can slide over the organs and other structures and it can be saved from the blocking effect of the surrounding tissues and the damage to the formations occurring inside the abdomen can be prevented. By means of this, for instance, intestine perforations and similar tissue damages can be prevented. As shown in details in Figure 7a and 7b, in the distal end apparatus (9), there is a mechanism (9b) which prevents back-flow of the liquid existing inside the abdomen and of the other structures like bacteria and parasite into the distal end (8). As shown in details in the different embodiments of the present invention in Figure 7a and 7b, said mechanism (9b) may comprise at least one membrane (9b-2) and/or at least one duck-billed valve (9b-1 ) which prevent(s) back-flow of the liquid inside the abdomen into the distal end (8) or the back-flow prevention characteristic can be utilized which results from the structure of the design without using membrane or valve according to physical dimensions. In Figure 8, the views of the notched/non-notched membranes (9b-2) and the possible duck-billed valve (9b-1 ) used in the distal end apparatus (9) are given. In the figures between Figure 9a and 9c, the schematic views of the operation of the mechanism (9b) which prevents liquid back-flow in the distal end apparatus (9) are given. As shown in Figure 9a and 9b, the liquid flows from the ventricle (V) side towards the peritoneum (P) side for instance when the patient stands up or when the patient is in lying position. As shown in Figure 9c, the flow of the liquid from the peritoneum (P) side towards the ventricle (V) side is prevented. Thanks to the subject matter distal end apparatus (9), the blockages are prevented and the infections related to this are also prevented. Thanks to the subject matter distal end apparatus (9), since liquid is permitted to pass in single direction, the liquids existing in the abdomen will not move upwardly and in this manner, bacteria and parasite are prevented from reaching the brain and thus, infections are also prevented. By means of this, liquid stasis can be prevented. By means of this, moreover, the blockages inside the abdomen are localized at a specific area and they are prevented from spreading.

In an embodiment of the present invention, the ventriculo-peritoneal shunt (1 ) comprises removable-fixable sections. By means of this, in case of blockage, the related sections can be changed by means of separate and small interventions instead of changing the whole ventriculo-peritoneal shunt (1 ). In an embodiment of the present invention, the first valve (3) and the second valve (7) provided on the ventriculo-peritoneal shunt (1 ) are removable and fixable. In a similar manner, in an embodiment of the present invention, the distal end apparatus (9) can be removed/fixed from/to the distal end (8). By means of this, in case of blockage, instead of changing whole of the ventriculo-peritoneal shunt (1 ), the first valve (3), the second valve (7) or the distal end apparatus (9) can be changed separately by means of small interventions. In an embodiment of the present invention, the ventriculo-peritoneal shunt (1 ) has an extendable structure by fixing an additional part between the removable/fixable sections. In an embodiment of the present invention, additional part can be fixed and extended in the abdomen region between the distal end (8) and the distal end apparatus (9). By means of this, when the height of the patient increases, for instance, when the height of the patient, who is 1 year old and who has a height of 70 cm and to whom ventriculo-peritoneal shunt (1 ) is fixed, increases up to 130 cm, only the distal end apparatus (9), connected to the distal end (8), is removed and the length of the ventriculo-peritoneal shunt (1 ) is extended by means of an additional part without completely changing the ventriculo-peritoneal shunt (1 ). After the extension process, the distal end apparatus (9) is fixed again and can be changed with a new one. Thanks to the removable/fixable sections in the subject matter ventriculo-peritoneal shunt (1 ), the patient gets rid of subcutaneous surgeries where the ventriculo-peritoneal shunt (1 ) is completely removed and changed with a new one and the patient is protected from complications of these surgeries like infection.