Slit valve intervention drainage shunt with adjustment structure

Abstract

The utility model relates to medical equipment technical field discloses a slit valve intervention drainage shunt pipe with adjusting structure, the utility model discloses a shunt pipe body with inlet and blind end is provided with valve slit and adjusting structure on the shunt pipe body lateral wall, and this is used for adjusting the opening pressure and flow rate of valve slit, and the adjusting structure is through -penetrating slit structure or non -through -penetrating slit structure. The utility model discloses the adjusting structure of being provided with the same circumference pipe body section with valve slit on the shunt pipe body, thereby weakening the elastic force of shunt pipe body, changes the opening pressure and flow resistance of valve slit, makes the opening of the valve slit of intervention drainage shunt pipe more stable.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a slit valve intervention drainage diversion tube with an adjustment structure. Background Technology

[0002] Hydrocephalus refers to the obstruction of cerebrospinal fluid (CSF) circulation pathways, resulting in excessive CSF production or absorption disorders. This excess CSF leads to widespread ventricular dilation, thus forming hydrocephalus. Typically, CSF is "shunt" using the following shunt types: ventriculoperitoneal shunts transfer CSF from the ventricles to the peritoneum; ventriculoperitoneal shunts transfer CSF from the ventricles to the heart; and lumbar-peritoneal shunts transfer CSF from the lower back to the peritoneum.

[0003] The standard treatment for hydrocephalus is the implantation of a shunt, which helps alleviate some of the symptoms. The shunt drains excess cerebrospinal fluid from the ventricles and redirects it to another part of the body. This procedure helps the enlarged ventricles return to their normal size and relieves hydrocephalus symptoms. Shunts are typically made of silicone and plastic, with all components placed under the skin. No parts are located outside the body. Existing shunts usually consist of a catheter and a valve (slit valve) on the catheter, typically located on the side wall of the catheter. The slit valve regulates the amount, direction, and pressure of cerebrospinal fluid flowing out of the ventricles. The principle of the slit valve is as follows: when the pressure inside the tube is greater than the pressure outside, the tube wall deforms under stress, opening the slit valve and allowing fluid to flow out; when the pressure inside the tube is less than the pressure outside, the tube wall returns to its normal shape and gradually closes. The greater the external pressure, the tighter the closure.

[0004] However, due to the unique characteristics of shunt tubes used for hydrocephalus, such as their thin walls and small diameter, the slit valves often fail to open stably. The main reasons for this instability include the electrostatic adsorption and adhesiveness of the silicone material in the shunt tube, and the increased pressure of unexpelled gas within the shunt lumen due to temperature rise after implantation, which affects normal drainage. This unstable opening pressure severely impacts the effectiveness and safety of the shunt tube. Therefore, it is necessary to propose a slit valve-guided drainage shunt with an adjustable structure. Utility Model Content

[0005] To solve the above-mentioned technical problems, this utility model provides a slit valve interventional drainage shunt with an adjustable structure, which can be deployed in the patient's ventricular system and venous system to stably drain cerebrospinal fluid from the patient's ventricular system to the venous system.

[0006] This utility model employs the following technical solution: a diversion pipe body with an inlet and a blind end. A valve slot and an adjustment structure are provided on the side wall of the diversion pipe body near the blind end. The adjustment structure is at least partially located on the same circumferential pipe section as the valve slot in the axial direction of the diversion pipe body, and its axial length is less than the axial length of the valve slot. It penetrates or does not penetrate the side wall of the diversion pipe body in the radial direction. This adjustment structure regulates the opening pressure and flow velocity of the valve slot, allowing the valve slot to open at a lower opening pressure and reducing the flow resistance when the slit valve opens, thus avoiding damage to the structure of the diversion pipe. The fact that the adjustment structure and the valve slot are on the same circumferential pipe section ensures that the adjustment structure can effectively adjust the valve slot.

[0007] As a further improvement to the above solution, the adjustment structure and the valve gap are at least partially axially overlapped, and the axial overlap length is less than the axial length of the valve gap, thereby ensuring that the adjustment structure achieves its adjustment function.

[0008] As a further improvement to the above solution, the adjustment structure is configured to extend inward from the outer wall of the diversion pipe body to form a non-penetrating adjustment structure, or to extend outward from the inner wall of the diversion pipe body to form a non-penetrating adjustment structure.

[0009] As a further improvement to the above solution, the adjustment structure is a through-type slit structure, a non-through-type slit structure, or a non-through-type hole structure.

[0010] As a further improvement to the above scheme, the through-type slit structure or the non-through-type slit structure is parallel to the central axis of the diversion pipe body, or parallel to the valve seam.

[0011] As a further improvement to the above solution, the adjustment structure is radially or partially radially aligned with the valve gap, thereby ensuring that the valve gap is within the influence range of the adjustment structure.

[0012] As a further improvement to the above solution, the number of the adjustment structures is one or more, and the axial length of a single adjustment structure is less than the axial length of the valve slot.

[0013] As a further improvement to the above solution, the adjustment structure includes a first adjustment structure and a second adjustment structure, the axial length of which is less than the axial length of the valve gap.

[0014] As a further improvement to the above scheme, the first adjustment structure and the second adjustment structure at least partially overlap axially.

[0015] As a further improvement to the above solution, the shunt tube body is made of silicone material and is provided with an anticoagulant coating.

[0016] Compared with the prior art, the beneficial effects of this utility model are as follows:

[0017] By setting adjustment structures on the same circumferential tube section of the valve seam (such as the opposite side or oblique opposite side), the elastic force of the shunt tube body can be weakened, thereby changing the valve seam opening pressure and flow resistance, ensuring the stability of valve seam opening on the interventional drainage shunt tube. At the same time, the strength of the shunt tube body can be further reduced by increasing the axial length, axial overlap length and number of adjustment structures to meet different clinical needs. Furthermore, the adjustment structure can be set as a through-type and non-through-type slit structure. When the adjustment structure is a non-through-type slit structure, it can not only reduce the strength of the shunt tube body, thus reducing the valve seam opening pressure and increasing the flow rate, ensuring that the shunt tube can work normally and stably, but when the adjustment structure is a through-type slit structure, it can further reduce the valve seam opening pressure and increase the flow rate. Attached Figure Description

[0018] Figure 1 This is a first illustration of a slit valve with an adjustment structure intervening in a diversion tube according to the present invention;

[0019] Figure 2 The illustration shows two different structural configurations.

[0020] Figure 3 A diagram showing the possible locations of through-type and non-through-type slit structures;

[0021] Figure 4 To adjust the curves of the structure under different pressures and the curves of the optimal scheme;

[0022] Figure 5 This is a diagram illustrating another embodiment of the slit valve with an adjustment structure used in the drainage diversion tube according to this utility model;

[0023] Figure 6 This is a schematic cross-sectional view of a sample of a slit valve with an adjustment structure used in a diversion tube according to the present invention.

[0024] Explanation of key symbols:

[0025] 1. Diverter pipe body; 2. Inlet; 3. Blind end; 4. Valve slot; 5. Adjustment structure; 501. Through-type slit structure; 502. Non-through-type slit structure. Detailed Implementation

[0026] The present invention will now be further described in conjunction with the accompanying drawings and specific embodiments.

[0027] Please combine Figures 1 to 6A slit valve interventional drainage shunt with an adjustable structure is used to stably drain cerebrospinal fluid from the ventricular system to the venous system when deployed in a patient's ventricular and venous systems. The interventional drainage shunt includes a shunt body 1 with an inlet 2 and a blind end 3, wherein the distal end with the inlet 2 is deployed in the patient's ventricular system, and the proximal end of the blind end 3 is deployed in the patient's venous system. In this application, "meninges" is used as an abbreviation to refer to the dura mater, arachnoid mater, venous sinus wall, inferior petrosal sinus wall, etc., to avoid excessive description. A self-expanding structure located at the distal end of the interventional shunt (…) Figure 5 (a) Card slot structure ( Figure 5 (b) Response deformation structure ( Figure 5 (c) or friction-enhancing structures such as glue are fixed to the dura mater to achieve fixation of the shunt tube at the dura mater.

[0028] The shunt tube body 1 is made of silicone material with an anticoagulant coating on the outer layer. The blind end 3 has a contrast-enhancing component for location identification. The shunt tube body 1 has a valve slit 4 and an adjustment structure 5 to regulate the opening pressure and flow rate of the valve slit 4. The adjustment structure 5 is at least partially located on the same circumferential segment of the shunt tube body 1 as the valve slit 4 in the axial direction, and its axial length is less than that of the valve slit 4. It penetrates or does not penetrate the sidewall of the shunt tube body 1 in the radial direction. By setting the adjustment structure 5 on the same circumferential segment of the valve slit 4, the opening pressure and flow resistance of the valve slit 4 can be changed, thus enabling stable opening of the valve slit 4 in interventional drainage shunts used in demanding applications. This avoids the problem of needing a longer valve slit 4 to meet the opening conditions but compromising the stability of the interventional drainage shunt, thus balancing the stable opening of the valve slit 4 with the stability of the interventional drainage shunt.

[0029] The axial length of the adjusting structure 5 is less than the axial length of the valve gap 4, which can ensure the adjusting function of the adjusting structure 5 while avoiding the valve gap 4 from being opened too low or open for a long time, thus affecting the unidirectional effect on cerebrospinal fluid drainage.

[0030] The adjustment structure 5 and the valve slot 4 are at least partially axially overlapped, and the axial overlap length is less than the axial length of the valve slot 4.

[0031] The adjustment structure 5 is configured as a non-penetrating adjustment structure extending inward from the outer wall of the branch pipe body 1, or as a non-penetrating adjustment structure extending outward from the inner wall of the branch pipe body 1. Among them, the non-penetrating adjustment structure 5 extending inward from the outer wall is simpler in terms of processing technology.

[0032] The adjustment structure 5 can be a through-type slit structure 501, a non-through-type slit structure 502, or a non-through-type hole structure (not shown). Both the through-type slit structure 501 and the non-through-type slit structure 502 can adjust the circumferential strength and stability of the diverter tube body 1. Compared with the through-type slit structure 501, the non-through-type slit structure 502 can improve the stability of the diverter tube body 1 while reducing the opening pressure of the valve slot 4 and increasing the flow rate. The through-type slit structure 501 can more effectively reduce the opening pressure of the valve slot 4 and increase the flow rate, but it will significantly reduce the strength of the diverter tube body 1. Furthermore, the number of adjustment structures 5 can be set to one or more as needed, and the axial length of a single adjustment structure 5 is less than the axial length of the valve slot 4.

[0033] The through-type slit structure 501 or the non-through-type slit structure 502 is parallel to the central axis of the diversion pipe body 1, or parallel to the valve slot 4.

[0034] The adjustment structure 5 includes a first adjustment structure and a second adjustment structure, both of which have an axial length less than the axial length of the valve slot 4. The first adjustment structure and the second adjustment structure at least partially overlap axially.

[0035] If there is only valve slot 4, such as valve slot 4 with a length of 7mm, its opening pressure is 1kPa. At 1.8kPa, the flow rate is 3ml / h. Due to the electrostatic adsorption and sticky surface of the silicone itself, even if the pressure reaches 1kPa, it cannot be opened stably. It needs to reach more than 3kPa. This unstable opening pressure can severely affect the effectiveness and implantation safety of the shunt tube. By adding a non-penetrating slit structure 502, the strength of the shunt tube body 1 is reduced, allowing the opening pressure to drop to 0.8 kPa and the flow rate to increase to 5 ml / h. The unstable opening pressure will also decrease, such as to 1 kPa (at which point the working pressure difference of the shunt tube is 1.1 kPa). The shunt tube can then open and function normally, although the flow rate will not be high enough. The non-penetrating slit structure 502 has its limits in reducing the strength of the shunt tube body 1 and presents manufacturing difficulties. To further reduce the opening pressure and increase the flow rate, a penetrating slit structure 501, or even multiple penetrating slit structures 501, will be used to reduce the strength of the tube body. Different adjustment structures 5 can be used to meet different clinical needs for opening pressure and flow rate.

[0036] The opening pressure of valve slot 4 refers to the pressure required for valve slot 4 to just open. When valve slot 4 just opens, it needs to overcome the residual stress from the forming and manufacturing of the pipe body and the force that causes the pipe to deform.

[0037] When the pipe body has only valve slit 4, the pressure inside the pipe is greater than the pressure outside the pipe. The pipe body deforms, increasing in radial direction. In the radial section, since the pipe body is a continuous volume, this manifests as the opening pressure overcoming the residual stress from molding and the force that causes deformation when valve slit 4 opens. From the perspective of the force causing pipe deformation, when only valve slit 4 is present, the opening pressure needs to overcome the internal stresses of mutual compression within the pipe body to open the slit.

[0038] The inner local adjustment structure 5 is set on the same circumferential section of the pipe body as the valve seam 4, dividing the local area into two parts. These two parts are in a free state with no residual stress. When opening, only the force that causes pipe deformation needs to be overcome. At the same time, this adjustment structure 5 reduces the force of the pipe body resisting the opening deformation at the valve seam 4, thereby adjusting the opening pressure of the valve seam 4. Similarly, when the outer local adjustment structure 5 is set on the same circumferential section of the pipe body as the valve seam 4, the local area is divided into two parts. These two parts are in a free state with no residual stress. When opening, only the force that causes pipe deformation needs to be overcome, thereby adjusting the opening pressure of the valve seam 4.

[0039] Combination Figures 3 to 4 The adjusting structure 5 and the valve gap 4 are located on the same circumferential pipe section. The adjusting structure 5 and the valve gap 4 are radially coincident or partially radially coincident. The adjusting structure 5 can be set on the opposite side of the valve gap 4 or on the oblique opposite side of the valve gap 4, so that the valve gap 4 is within the influence range of the adjusting structure 5, and the adjusting structure 5 can play an adjusting role on the valve gap 4.

[0040] exist Figure 4 In the diagram, curve 1 represents the flow velocity curve of the adjustment structure under different pressures, while curve 2 represents the flow velocity curve of the preferred scheme of the adjustment structure under different pressures.

[0041] Because within the same circumferential pipe section, the adjustment structure 5 can weaken the elastic force of the diversion pipe body 1, thereby changing the opening pressure and flow resistance of the valve slot 4. The flow resistance is reflected in the different flow velocities under the same pressure. The diversion pipe body 1 is a silicone tube with a hardness of 70A, a wall thickness of 0.13-0.3mm, an inner diameter of 0.2-0.3mm, and a length of 30mm. When the valve slot 4 is 7mm, it opens unstablely at 1.1kPa. With the adjustment structure 5 set on the opposite side of the valve slot 4 with a diameter of 5-6mm, the opening pressure is 0.4-0.6kPa, and the flow velocity is approximately 4-7ml / hour under a pressure difference of 1.1kPa.

[0042] Furthermore, when three through-type slit structures 501 or non-through-type slit structures 502 are evenly distributed upwards in the same circumference as adjustment structures 5, and their lengths are all less than the length of the valve slit 4, for example, the lengths are 5mm, 6.9mm, and 5mm respectively, an opening pressure of 0.1-0.4kPa can be achieved, and the flow rate is approximately 8-12ml / hour under a pressure difference of 1.1kPa.

[0043] The tube body is made of silicone with a hardness of 70A, a wall thickness of 0.13-0.3mm, an inner diameter of 0.2-0.3mm, and a length of 30mm. When the valve slot 4 is 7mm, the specific data for the main valve flow rate (ml / hour) are as follows:

[0044] Sample 1 has a valve slot of only 7mm;

[0045] Samples 2-8 have a 7mm valve gap 4 and an adjustment structure 5, with a 5mm adjustment structure 5, as shown in Figure 7(a).

[0046] Samples 9-11 have a 7mm valve slot 4 and two adjustment structures 5, one 2mm adjustment structure 5 and the other 5mm adjustment structure 5. See Figure 6 (b);

[0047] Samples 12-22 consist of a 7mm valve slot 4 and three adjustment structures 5, with adjustment structures 5 being 5mm, 6.9mm, and 5mm in diameter, respectively. (See attached image.) Figure 6 (c).

[0048] The differential pressure flow meter shows that only valve slit 4 (sample 1) requires a large differential pressure to open stably, and the flow rate is small, failing to open stably at 1.1 kPa.

[0049] When an adjustment structure 5 is added (samples 2-8), it can be stably opened under a lower pressure difference;

[0050] When three adjustment structures 5 are added (samples 9-11 and 12-22), the flow rate can be increased and the system can be stably opened at a lower differential pressure.

[0051] Differential pressure flow meters for valve slots of different lengths and with different numbers of adjustment mechanisms:

[0052]

[0053] The axial overlap length between the adjustment structure 5 and the valve slot 4 is less than the axial length of the valve slot 4, and the axial length of a single adjustment structure 5 is less than the axial length of the valve slot 4. The specific length is set according to the required valve opening pressure, flow rate, etc. When the diversion tube body 1 is in the capillary thin-walled tube, under the action of ventricular pressure, cerebrospinal fluid flows out from the valve slot 4 with a smaller opening pressure and a larger flow rate, while the flow rate of the adjustment structure 5 is relatively slower, or even in a closed state, only serving to adjust the opening pressure and flow rate of the valve slot 4. (When the through-type slit structure 501 is set, the axial overlap length between the adjustment structure 5 and the valve slot 4 is less than that of the valve slot 4. The through-type slit structure 501 is similar to the valve slot 4. Under the same conditions, the shorter the valve slot 4, the greater the pressure required for its opening. Therefore, the opening pressure of the through-type slit structure 501 is greater than that of the valve slot 4. When the valve slot 4 is open, the adjustment structure 5 will not open, or will open only slightly, and its flow rate is slower than that of the valve slot 4.)

[0054] The above embodiments are merely preferred embodiments of this utility model and should not be construed as limiting the scope of protection of this utility model. Any non-substantial changes and substitutions made by those skilled in the art based on this utility model shall fall within the scope of protection claimed by this utility model.

Claims

1. A slit valve-intercepting drainage diversion tube with an adjustment structure, comprising: The shunt pipe body (1) is provided with an inlet (2) and a blind end (3), characterized in that: The side wall of the diversion pipe body (1) near the blind end (3) is provided with a valve slot (4) and an adjustment structure (5). The adjustment structure (5) is at least partially located on the same circumferential pipe body segment as the valve slot (4) in the axial direction of the diversion pipe body (1) and its axial length is less than the axial length of the valve slot (4). It penetrates or does not penetrate the side wall of the diversion pipe body (1) in the radial direction.

2. The slit valve-intervention drainage diversion pipe with an adjustment structure as described in claim 1, characterized in that, The adjustment structure (5) and the valve slot (4) are at least partially axially overlapped, and the axial overlap length is less than the axial length of the valve slot (4).

3. A slit valve with an adjustment structure for intervention in a diversion and drainage pipe as described in claim 2, characterized in that, The adjustment structure (5) is configured to extend inward from the outer wall of the shunt tube body (1) to form a non-penetrating adjustment structure, or to extend outward from the inner wall of the shunt tube body (1) to form a non-penetrating adjustment structure.

4. A slit valve with an adjustment structure for inserting a diversion tube as described in claim 2, characterized in that, The adjustment structure (5) is a through slit structure (501), a non-through slit structure (502), or a non-through hole structure.

5. A slit valve with an adjustment structure for inserting a diversion tube as described in claim 4, characterized in that, The through-type slit structure (501) or the non-through-type slit structure (502) is parallel to the central axis of the shunt pipe body (1) or parallel to the valve slot (4).

6. A slit valve-intervention drainage diversion pipe with an adjustment structure as described in claim 1, characterized in that, The adjustment structure (5) is radially or partially radially overlapped with the valve slot (4).

7. A slit valve with an adjustment structure for a diversion and drainage pipe as described in claim 1, characterized in that, The number of the adjustment structure (5) is one or more, and the axial length of a single adjustment structure (5) is less than the axial length of the valve slot (4).

8. A slit valve-intervention drainage diversion pipe with an adjustment structure as described in claim 7, characterized in that, The adjustment structure (5) includes a first adjustment structure and a second adjustment structure, the axial lengths of which are both less than the axial length of the valve gap (4).

9. A slit valve-intervention drainage diversion pipe with an adjustment structure as described in claim 8, characterized in that, The first adjustment structure and the second adjustment structure at least partially overlap axially.

10. A slit valve-intervention drainage diversion pipe with an adjustment structure as described in claim 1, characterized in that, The shunt tube body (1) is made of silicone material and is provided with an anticoagulant coating.

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