Intraventricular hydrops drainage device

Abstract

The invention relates to an instrument for transferring cerebrospinal fluid in a ventricle into a body cavity of other parts of a human body, and particularly discloses an intraventricular hydrops drainage device which comprises a base used for being attached to a bone window of a skull, a confluence cavity and a liquid outlet connector communicated with the confluence cavity are arranged on the base, and the liquid outlet connector is provided with a liquid inlet and a liquid outlet. The flow guide hose is connected to the liquid outlet joint; a tip axially remote from the base; the drainage main body component is used for guiding cerebrospinal fluid in the ventricle to the confluence cavity; the drainage main body component comprises a plurality of micro-catheters; the near end and the far end of each micro catheter are attached to the base and the end respectively, and the near end of the micro central hole of each micro catheter is communicated with the confluence cavity; the micro-conduits are arranged in a plurality of circles in the circumferential direction and the radial direction; a micro drainage structure communicated with the micro central hole is arranged on the tube wall of each micro catheter, and the micro drainage structures are arranged in the circumferential direction and the axial direction of the tube wall of the micro catheter so as to allow cerebrospinal fluid to enter the micro central hole through the tube wall of the micro catheter.

Description

Technical Field

[0001] The present invention relates to an apparatus for transferring body fluids from a human body, and in particular to a device for draining intraventricular hydrops. Background Art

[0002] Hydrocephalus is a typical neurological disease caused by excessive accumulation of cerebrospinal fluid in the ventricles. The direct consequence of hydrocephalus is increased pressure in the ventricles, that is, the so-called increased intracranial pressure, which squeezes the brain tissue. Hydrocephalus may be caused by a variety of reasons, for example, damage to the intracranial brain tissue caused by mechanical impact, for example, caused by diseases of the brain tissue itself, specifically caused by abnormal cerebrospinal fluid metabolism, cerebral hemorrhage, cerebral infarction, encephalitis and other diseases. Regardless of the cause of hydrocephalus, draining excess cerebrospinal fluid from the ventricles to reduce the pressure in the ventricles to a reasonable level (at least to a level that does not cause serious consequences to the brain tissue) is the primary and urgent medical treatment option.

[0003] Drainage techniques and drainage systems have been developed for transferring cerebrospinal fluid from a patient's ventricles to other body cavities (e.g., the abdominal cavity). Typical drainage systems include a tubular drainage component for percranial implantation into the ventricles, a flexible conduit for transporting cerebrospinal fluid drawn through the drainage component to another body cavity, and a flow control valve positioned at the tail (proximal end) of the drainage component or on the flexible conduit to control the flow rate of cerebrospinal fluid and thereby prevent excessive drainage. A typical drainage structure of a drainage component includes a central drainage lumen disposed within the drainage component and numerous wall holes formed in the wall of the drainage component. Cerebrospinal fluid enters the drainage lumen through the numerous wall holes, flows along the drainage lumen toward the proximal end of the drainage component, and then flows into the flexible conduit. The pore size of the wall hole cannot be too large and is required to be configured as a micropore. The reason is that: on the one hand, larger wall holes will allow some substances in the cerebrospinal fluid (such as protein particles, fragments, and blood clot particles) with larger particle sizes to flow into the diversion hose and the control valve, which may block the diversion hose and the control valve; on the other hand, larger wall holes will allow a larger area of ​​brain tissue (usually brain tissue such as the choroid plexus growing around the drainage component) to invade. When the drainage component is removed from the ventricle, the shearing effect of the edge of the wall hole on the invading part of the brain tissue may cause brain tissue damage.

[0004] Although configuring the drainage component's wall holes as micropores can significantly reduce the probability of blockage of the drainage hose and control valve and prevent shear damage to brain tissue, configuring the wall holes as micropores has the unfortunate consequence of making them susceptible to blockage. This blockage can occur in a variety of ways. For example, the choroid plexus surrounding the drainage component can invade the wall holes, causing them to become blocked. Another example is that protein fragments can cover the outer surface of the drainage component due to throttling pressure differentials, blocking the holes from the outer ends. Another example is that protein particles or blood clots can accumulate directly or through accumulation at the wall holes, ultimately blocking them. If the percentage of blocked wall holes in the drainage component reaches a certain level, the drainage component will lose its drainage function (the probability of this loss is high, especially after long-term use), and the intraventricular pressure will not be reduced to a reasonable level. This is the most serious complication that can occur after shunt surgery.

[0005] To reduce the probability of obstruction of the wall holes in the drainage component, a method developed in the prior art is to place a disturbance component (e.g., a disturbance rod) in the drainage cavity of the drainage component. A wire harness (e.g., a brush) is attached to the disturbance component, which is used to penetrate the wall holes. The disturbance component is driven to move, causing the wire harness to disturb the wall holes to prevent obstruction. This method has a certain effect in preventing wall hole obstruction. However, this method has the following drawbacks: 1. An electric drive component (e.g., an ultrasonic drive module) for electrically driving the disturbance component and a power supply for providing electrical energy to the electric drive module need to be configured on the drainage component, which complicates the structure of the drainage component; 2. If the disturbance of the wire bundle touches the brain tissue, it may cause damage to the brain tissue; 3. If the wire bundle is restricted from extending out of the outer end of the wall hole in order to reduce the probability of touching the brain tissue, the disturbance effect of the wire bundle will make it difficult to prevent protein fragments from blocking the wall hole; 4. The driving wire bundle to disturb the wall hole is not effective in preventing the choroid plexus from blocking the wall hole, and the disturbance effect may induce the choroid plexus to grow toward the wall hole. Summary of the Invention

[0006] In view of the above technical problems existing in the prior art, the present invention provides a drainage device for intraventricular hydrops.

[0007] In order to solve the above technical problems, the technical solution adopted by the present invention is:

[0008] A drainage device for intraventricular hydrocele, comprising:

[0009] A base, which is used to be attached to the bone window of the skull, wherein the base is provided with a confluence cavity and a liquid outlet connector communicating with the confluence cavity, and a diversion hose is connected to the liquid outlet connector;

[0010] a tip axially distal from the base;

[0011] The drainage main body component is used to guide the cerebrospinal fluid in the ventricle to the confluence cavity; wherein:

[0012] The drainage main body component includes a plurality of microcatheters; the proximal end and distal end of each microcatheter are attached to the base and the end head respectively, and the micro-center hole of each microcatheter is connected to the confluence cavity at the proximal end; all the microcatheters are arranged in multiple circles along the circumferential direction and the radial direction;

[0013] The wall of each microcatheter is provided with a microdrainage structure penetrating the microcentral hole. The microdrainage structure is arranged circumferentially and axially along the wall of the microcatheter to allow cerebrospinal fluid to enter the microcentral hole through the wall of the microcatheter.

[0014] Preferably, the microdrainage structure comprises a plurality of linear slit-shaped holes; the plurality of linear slit-shaped holes are arranged circumferentially and axially on the wall of the microcatheter; wherein:

[0015] Each linear slit hole extends along the axial direction of the microcatheter, and the width of each linear slit hole increases from the distal end to the proximal end of the microcatheter, and the maximum width of the linear slit hole is smaller than the diameter of the microcenter hole.

[0016] Preferably, the micro-drainage structure is a spiral slit formed on the micro-catheter and extending helically, and the width of the spiral slit is smaller than the diameter of the micro-center hole.

[0017] Preferably, the drainage main body component further comprises a redundant catheter, and the redundant catheter is located in the central area of ​​the columnar space enclosed by the plurality of microcatheters;

[0018] The redundant catheter defines a central lumen, the proximal end and the distal end of the redundant catheter are attached to the base and the tip, respectively, and the central lumen is connected to the confluence lumen at the proximal end; a redundant drainage structure is configured on the wall of the redundant catheter and is in communication with the central lumen, and the redundant drainage structure can allow cerebrospinal fluid to enter the central lumen so that the redundant catheter can guide the cerebrospinal fluid to the confluence lumen; wherein:

[0019] The drainage timing of the redundant catheter is configured so that after the pressure in the ventricle is greater than the set pressure, cerebrospinal fluid is allowed to enter the confluence cavity through the redundant drainage structure and the central cavity.

[0020] Preferably, the redundant drainage structure comprises a plurality of drainage windows arranged on the wall of the redundant conduit, wherein the plurality of drainage windows are arranged circumferentially and axially; wherein:

[0021] The inner hole wall of the redundant catheter and the area corresponding to each drainage window are each provided with a valve plate. In response to the pressure of the cerebrospinal fluid rising to be greater than the set pressure, the valve plate opens the drainage window through elastic deformation forced by the pressure, and closes the drainage window through elastic resetting.

[0022] Preferably, a mesh spacer is provided between the redundant catheter and the micro-catheter of the inner ring;

[0023] The outer circumference of the redundant conduit is configured with a plurality of ribs arranged at intervals along the axial direction, each rib having a circumferentially arranged and axially penetrating groove; the ribs separate the grid spacer from the outer circumference of the redundant conduit.

[0024] Preferably, the redundant drainage structure comprises a plurality of micropores arranged on the wall of the redundant conduit; wherein:

[0025] A check valve component is installed at the intersection of the confluence cavity of the base and the central cavity of the redundant catheter. The check valve component allows cerebrospinal fluid to flow from the central cavity to the confluence cavity while restricting reverse flow. In addition, the check valve component has an opening pressure that allows cerebrospinal fluid to flow from the central cavity to the confluence cavity.

[0026] Preferably, a check valve component is installed at the intersection of the confluence cavity of the base and the central hole of the redundant catheter, and the check valve component allows cerebrospinal fluid to flow from the central cavity to the confluence cavity while limiting reverse flow.

[0027] Preferably, a transparent observation window is provided at the top of the base in an area opposite to the confluence cavity.

[0028] Preferably, the base is further provided with a liquid inlet and outlet joint, the liquid inlet joint is communicated with the confluence cavity, the liquid inlet joint and the liquid outlet joint both extend radially and are arranged in parallel with the liquid inlet joint.

[0029] Preferably, the linear slit-shaped holes on the microcatheter are formed by cutting with a micro knife or by laser engraving.

[0030] Preferably, the spiral seam on the microcatheter is formed by winding a strip around a core needle with spiral ribs and then thermoforming.

[0031] Compared with the prior art, the intraventricular hydrops drainage device disclosed in the present invention has the following beneficial effects:

[0032] 1. The present invention utilizes a plurality of microcatheters with microdrainage structures configured on the tube wall and arranged in multiple circles to drain the cerebrospinal fluid, thereby improving the drainage effect of the cerebrospinal fluid from aspects such as increasing the total flow cross-section and preventing blockage.

[0033] 2. The present invention uses linear slits or spiral slits on the wall of the microcatheter as micro-drainage structures, which further improves the drainage effect of cerebrospinal fluid from the perspective of preventing blockage.

[0034] 3. The present invention adds redundant catheters and accessories, so that the drainage function can be played when the microcatheter drainage fails or is close to failure, thereby providing a redundant drainage function for the drainage device.

[0035] 4. Other advantages of the present invention are directly or implicitly recorded in the specific embodiments of the specification.

[0036] This disclosure is an overview of various implementations or examples of the technology, and is not a comprehensive disclosure of the full scope or all features of the disclosed technology. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] In the drawings, which are not necessarily drawn to scale, the same reference numerals may describe similar components in different views. The same reference numerals with letter suffixes or different letter suffixes may represent different instances of similar components. The accompanying drawings generally illustrate various embodiments by way of example and not limitation, and together with the description and claims, serve to illustrate the embodiments of the invention. Where appropriate, the same reference numerals are used throughout the drawings to refer to the same or similar parts. Such embodiments are illustrative and are not intended to be exhaustive or exclusive of the embodiments of the present apparatus or method.

[0038] Figure 1 This is the state of the drainage device provided by an embodiment of the present invention implanted in a patient's cerebral ventricle.

[0039] Figure 2 This is a schematic diagram of the three-dimensional structure of the drainage device provided by an embodiment of the present invention.

[0040] Figure 3 It is a schematic diagram of the three-dimensional structure of a drainage device equipped with a microcatheter of the first micro-drainage structure and a redundant catheter of the first structure (only part of the microcatheter is shown).

[0041] Figure 4 Schematic diagram of the three-dimensional structure of the microcatheter of the first microdrainage structure.

[0042] Figure 5 This is a structural view of a drainage device equipped with a first type of redundant catheter (the redundant catheter is not involved in drainage).

[0043] Figure 6 This is a structural view of a drainage device equipped with a first type of redundant catheter (the redundant catheter is in a state of participating in drainage).

[0044] Figure 7Schematic diagram of attaching the valve sheet during the production of the first type of redundant catheter.

[0045] Figure 8 Schematic diagram of attaching ribs during the production of the first type of redundant catheter.

[0046] Figure 9 It is a schematic diagram of the three-dimensional structure of a drainage device equipped with a microcatheter of the second micro-drainage structure and a redundant catheter of the second structure (only part of the microcatheter is shown).

[0047] Figure 10 Schematic diagram of the three-dimensional structure of the microcatheter of the second microdrainage structure.

[0048] 10- drainage main body; 11- microcatheter; 111- micro-center hole; 112- linear slit hole; 113- spiral slit; 12- redundant catheter; 121- central cavity; 122- drainage window; 1221- window; 1222- connecting rib; 123- rib; 1231- groove; 124- micropore; 13- spacer; 20- base; 21- proximal jack; 22- proximal center jack; 23- confluence cavity; 241- liquid outlet connector; 24 2-liquid inlet connector; 25-port; 26-visual window; 30-end; 31-distal jack; 32-distal center jack; 40-valve plate; 41-elastic strip; 50-check valve; 51-circular plate; 511-valve port; 52-circular silicone sheet; 60-check valve; 70-holding component; 71-mounting hole; 72-through hole; 100-drainage device; 200-diversion hose; 300-ventricle; 301-skull; 400-thin strip. DETAILED DESCRIPTION

[0049] Unless otherwise defined, the technical or scientific terms used in the present invention shall have the usual meanings understood by persons of ordinary skill in the field to which the present invention belongs. The words "first", "second" and similar terms used in the present invention do not indicate any order, quantity or importance, but are only used to distinguish different components. Words such as "include" or "comprise" mean that the elements or objects preceding the word include the elements or objects listed after the word and their equivalents, without excluding other elements or objects. Words such as "connect" or "connected" are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "Up", "down", "left", "right" and the like are only used to indicate relative positional relationships. When the absolute position of the object being described changes, the relative positional relationship may also change accordingly.

[0050] In order to keep the following description of the embodiments of the present invention clear and concise, detailed descriptions of known functions and known components are omitted.

[0051] like Figure 1 As shown, an embodiment of the present invention discloses a drainage device 100 for intraventricular hydrops. The device, as a core component of a drainage system, is implanted into the ventricle 300 through a bone window of the skull 301 during drainage surgery to drain excess cerebrospinal fluid from the patient's ventricle 300. The drained cerebrospinal fluid is transported to other body cavities (e.g., the abdominal cavity) of the patient through a drainage hose 200. A control valve installed on the drainage hose 200 is used to control the flow of cerebrospinal fluid to avoid excessive drainage.

[0052] like Figure 2 As shown, the overall shape of the drainage device 100 disclosed in the present invention is roughly cylindrical. Therefore, the device has two ends in the axial direction. After the device is implanted, one end of the device extends into the ventricle 300 through the bone window of the skull 301, and the other end of the device is exposed on the outside of the skull 301. The end of the device used to extend into the ventricle 300 is called the distal end, and the end of the device used to be exposed on the outside of the skull 301 is called the proximal end.

[0053] like Figures 2 to 10 As shown, the drainage device 100 disclosed in the present invention includes: a base 20 located at the proximal end, an end 30 located at the distal end, and a drainage main body component 10 between the end 30 and the base 20. After the device is implanted in the ventricle 300, the drainage main body component 10 is basically located in the ventricle 300.

[0054] The base 20 is attached to the skull 301 via a retaining member 70. Specifically, the retaining member 70 is a plate-like structure with a mounting hole 71 located in the center and circumferentially arranged through-holes 72 located at the edge. Before implanting the drainage device 100 into the ventricle 300, a bone window is first drilled in a suitable area of ​​the skull 301. The mounting hole 71 of the retaining member 70 is then aligned with the bone window. A bone screw is then inserted through the through-hole 72 at the edge of the retaining member 70 and screwed into the skull 301 to secure the retaining member 70 to the skull 301. When implanting the drainage device 100 into the ventricle 300, the distal end of the device extends from above the retaining member 70, through the mounting hole 71, and into the skull 301 until the base 20 is inserted into the mounting hole 71. At this point, the retaining member 70, through the mounting hole 71, mates with the base 20 to position the device, preventing axial and radial movement and shaking. The mounting hole 71 and the base 20 can be positioned by means of an assembly fit including but not limited to the following: a downward-facing step surface is arranged on the outer peripheral surface of the base 20, a flat stop surface is arranged at the end of the mounting hole 71, and a screw-on structure is arranged on the outer peripheral surface of the base 20 and the wall hole of the mounting hole 71. The base 20 is screwed at a small angle so that the base 20 is engaged with the retaining component 70, and the step surface abuts against the stop surface.

[0055] like Figure 3 and Figure 9 As shown, a confluence cavity 23 and a liquid outlet connector 241 connected to the confluence cavity 23 are configured on the base 20, which is used to connect the diversion hose 200 in the body cavity of other parts to which the cerebrospinal fluid is ultimately transported to the liquid outlet connector 241. Specifically, a circular sink is opened from the top of the base 20 (or the proximal end of the base 20) to the bottom of the base 20 (or the distal end of the base 20), and a cover is provided on the top of the base 20 to cover the sink, thereby defining the confluence cavity 23; the liquid outlet connector 241 extends radially from the side of the base 20, and the diversion hose 200 is horizontally attached to the liquid outlet connector 241, so that it can follow the direction of the diversion hose 200 to avoid being accidentally touched.

[0056] The lower end of tip 30 (or the distal end of tip 30) is configured with a spherical surface. During device implantation into the cerebral ventricle 300, this spherical surface can significantly reduce potential damage to brain tissue. Preferably, tip 30 is configured as a hemispherical structure, with the upper end of tip 30 (or the proximal end of tip 30) being a flat, circular surface.

[0057] The drainage main body component 10 includes a plurality of microcatheters 11 each having a micro-center hole 111. The proximal and distal ends of each microcatheter 11 are attached to the base 20 and the tip 30, respectively. The micro-center hole 111 of the microcatheter 11 is connected to the confluence cavity 23 of the base 20 at the proximal end, while the micro-center hole 111 is blocked at the distal end. All microcatheters 11 are arranged in both circumferential and radial directions, thereby forming multiple circles of microcatheters 11. Specifically, the bottom of the trough is provided with multiple circles of proximal jacks 21 that correspond one-to-one with each microcatheter 11 and extend to the bottom of the base 20. The upper end of the tip 30 is provided with multiple circles of distal jacks 31 that correspond one-to-one with each microcatheter 11. The distal end of the microcatheter 11 is inserted into the distal jack 31 of the tip 30, and the proximal end of the microcatheter 11 is inserted into the proximal jack 21 of the base 20. Both are bonded and fixed using a colloid of preferably biocompatible material.

[0058] A microdrainage structure is configured on the wall of the distal section of each microcatheter 11 (the brain tissue area corresponding to the proximal section of the microcatheter 11 is generally a non-target drainage area and generally does not require a microdrainage structure. Of course, if the brain tissue area corresponding to the proximal section is also determined to be a target drainage area, a microdrainage structure may be configured on the entire wall of the microcatheter 11 along its length). The microdrainage structure is connected to the micro-center hole 111, and the microdrainage structure is arranged circumferentially and axially along the wall of the microcatheter 11 so that a microdrainage structure is present in all circumferential directions and at all axial positions of the wall of the distal section. Because the microdrainage structure is connected to the micro-central hole 111, under the action of cerebrospinal fluid pressure (i.e., the pressure within the ventricle 300), the cerebrospinal fluid can enter the micro-central hole 111 through the microdrainage structure on each microcatheter 11, flow along the micro-central hole 111 toward the proximal end, and merge into the confluence cavity 23, and then be transported through the diversion tube 200 to flow into other body cavities. The microdrainage structure can be a circular or quasi-circular (e.g., elliptical, oval, polygonal) micropore with a high density arrangement. The microdrainage structure can also be a plurality of linear slit holes 112 or spiral slits 113 provided by the present invention and described below.

[0059] The advantages of the drainage main body component 10 for draining cerebrospinal fluid using the microcatheters 11 arranged in multiple circles are as follows.

[0060] 1. The numerous microcatheters 11 arranged in multiple circles can achieve a larger area of ​​contact with the cerebrospinal fluid than a conventional catheter having a size roughly equal to the cylindrical surface enclosed by the microcatheters 11 (the outermost circle of microcatheters 11). Therefore, by rationally configuring the microdrainage structures (e.g., configuring them as circular or quasi-circular holes) and maximizing the density of the microdrainage structures, the sum of the flow cross-sections of the microdrainage structures of all microcatheters 11 can be made greater than the sum of the flow cross-sections of all the wall holes of a conventional catheter. In this way, even if the proportion of blocked microdrainage structures on a microcatheter 11 is greater than the proportion of blocked wall holes on a conventional catheter, the drainage effect of all the microcatheters 11 on the cerebrospinal fluid is still superior to that of a conventional catheter.

[0061] 2. It has advantages in preventing blockage by protein fragments. Specifically, because the outer diameter of the microcatheter 11 is much smaller than that of an ordinary catheter, smaller protein fragments are more difficult to stably adhere to the cylindrical surface of the microcatheter 11 compared to ordinary catheters. Larger protein fragments, compared to ordinary catheters, are less likely to adhere entirely to the cylindrical surface. The covered area of ​​the microcatheter 11 is smaller, resulting in a smaller flow cross-section of the microdrainage structure that can be blocked. However, larger protein fragments can fully cover the cylindrical surface of an ordinary catheter, resulting in a larger flow cross-section of the micropores in the ordinary catheter that can be blocked.

[0062] 3. It offers advantages in preventing choroid plexus obstruction. Specifically, by arranging microcatheters 11 in multiple circles, the choroid plexus is blocked by the outermost microcatheters 11 and is less likely to reach the inner microcatheters 11. Consequently, the microdrainage structures of the inner microcatheters 11 are less likely to be blocked by the choroid plexus. Furthermore, while the choroid plexus can block the microdrainage structures located radially outward (or substantially radially outward) on the outermost microcatheters 11, the likelihood of blockage in the radially inward region is low.

[0063] The present invention provides two micro-drainage structures disposed on the wall of the micro-catheter 11 .

[0064] The first micro-drainage structure.

[0065] like Figures 3 to 5 As shown, the microdrainage structure includes a plurality of linear slit-like holes 112 disposed on the wall of the microcatheter 11. The plurality of linear slit-like holes 112 are arranged both circumferentially and axially so that a linear slit-like hole 112 exists in all circumferential directions and at all axial positions on the wall of the microcatheter 11. Each linear slit-like hole 112 extends axially along the microcatheter 11 so that its extension direction aligns with the flow direction of cerebrospinal fluid within the microcentral bore 111 of the microcatheter 11. Furthermore, the width of the linear slit-like hole 112 increases from the distal end to the proximal end of the microcatheter 11, i.e., the width of the linear slit-like hole 112 is greater on the proximal side than on the distal side, and the maximum width of the linear slit-like hole 112 is smaller than the diameter of the microcentral bore 111, i.e., the width of the linear slit-like hole 112 on the proximal side is smaller than the diameter of the microcentral bore 111.

[0066] Using numerous linear slit-like holes 112 as a micro-drainage structure has the following advantages in preventing blockage:

[0067] 1. The linear slit-shaped holes 112 with a larger aspect ratio can better inhibit blockage caused by aggregation of protein microparticles than circular holes or quasi-circular holes.

[0068] 2. By extending the linear slit pores 112 along the direction of cerebrospinal fluid flow within the micro-central pore 111 and increasing the slit width along the flow direction, protein particles initially intercepted by the linear slit pores 112 as the cerebrospinal fluid passes through them can be guided by the linear slit pores 112 toward the proximal end, potentially eventually entering the micro-central pore 111 through the wider slit, thereby reducing the probability of blockage to a certain extent. Furthermore, even if a protein particle is ultimately intercepted at a certain location within the linear slit pores 112, other locations within the linear slit pores 112 still allow cerebrospinal fluid to pass through. Furthermore, even if a protein particle is ultimately intercepted at a certain location within the linear slit pores 112, the stability of the protein particle remaining in that location is poor because the linear slit pores 112 are open in the axial direction.

[0069] The main body of the microcatheter 11 of the above-described structure can be made of a biocompatible polymer material (e.g., medical polyurethane) through an extrusion process. The linear slit-like holes 112 in the wall of the microcatheter 11 can be cut into the wall using a microblade or laser engraved using a laser engraver. Before cutting the wall with a microblade or engraving the wall with a laser engraver, a metal core needle (if cutting with a blade, a notch corresponding to the linear slit-like hole 112) must be inserted through the microcatheter 11 to provide support and prevent the laser from penetrating the microcatheter 11.

[0070] The second micro-drainage structure.

[0071] like Figure 9 and Figure 10 As shown, the drainage structure is a spiral slit 113 formed on the microcatheter 11, and the width of the spiral slit 113 is smaller than the diameter of the micro-center hole 111. The area of ​​the flow cross section defined by the spiral slit 113 per unit axial dimension can be increased by reducing the pitch of the spiral slit 113.

[0072] The second microdrainage structure has similar advantages to the first: it effectively avoids clogging by protein particles. Compared to the first microdrainage structure, this microdrainage structure, with its continuous, longer slits, is more stable against protein particles trapped within the slits.

[0073] The structural microcatheter 11 can also be made of a high molecular polymer material which is preferably a biocompatible material. The present invention provides two manufacturing processes.

[0074] The first manufacturing process is similar to the manufacturing process of the first microcatheter 11 , that is, the main body of the microcatheter 11 is manufactured by an extrusion process, and then the spiral slit 113 is cut by a micro blade or engraved by a laser engraving machine.

[0075] The second manufacturing process involves cutting numerous strips from a sheet of raw material. These strips are then wrapped around a core needle under heating conditions, along the direction of the spiral ribs on the core needle. The strips are then cooled and shaped, resulting in a microcatheter 11 having a spiral slit 113. The width of the spiral ribs determines the width of the spiral slit 113.

[0076] In some preferred embodiments of the present invention, Figure 3 and Figure 9 As shown, the drainage main body component 10 further includes a redundant catheter 12, the radial dimension of which is significantly larger than the radial dimension of the microcatheter 11. The redundant catheter 12 defines a central cavity 121, as shown in FIG. Figure 5 As shown, the redundant catheter 12 is arranged in the central section of the cylindrical space enclosed by all microcatheters 11. The proximal end of the redundant catheter 12 is inserted into the proximal central insertion hole 22, which is provided in the central region of the base 20 and communicates with the confluence lumen 23, thereby connecting the central lumen 121 with the confluence lumen 23. The distal end of the redundant catheter 12 is blocked and inserted into the distal central insertion hole 32, which is provided in the central region of the tip 30. A drainage structure is configured on the wall of the distal section of the redundant catheter 12, which may be referred to as a redundant drainage structure. This redundant drainage structure penetrates the wall and communicates with the central lumen 121. In this way, cerebrospinal fluid can enter the central lumen 121 through the redundant drainage structure. Subsequently, the cerebrospinal fluid can flow along the central lumen 121 toward the proximal flow channel and enter the confluence lumen 23. Thus, the redundant catheter 12 can achieve drainage of cerebrospinal fluid.

[0077] In the present invention, the redundant catheter 12 is configured to initiate drainage when the numerous microcatheters 11 fail or are near failure due to blockage of the microdrainage structure or other reasons ("failure of drainage" should not be understood as a complete inability to drain, but rather as a condition where, while drainage is possible, the cerebrospinal fluid flow rate is reduced to a point where the pressure in the ventricle 300 cannot be reduced to a reasonable or desired level). In the present invention, the failure of the microcatheter 11 drainage function is determined based on the pressure in the ventricle 300, and the involvement of the redundant catheter 12 in drainage is then determined. Therefore, the timing of drainage by the redundant catheter 12 is specifically set as follows: if the pressure in the ventricle 300 exceeds a set pressure, the redundant catheter 12 is activated. The set pressure is typically set based on normal ventricle 300 pressure. For adults, normal ventricle 300 pressure is 5-15 mmHg. If the ventricle 300 pressure exceeds 20 mmHg, it is generally considered intracranial hypertension. Therefore, the set pressure can be set to 15-20 mmHg. In the present invention, the redundant catheter 12 is automatically drained in real time in response to the pressure of the ventricle 300 .

[0078] The present invention provides two specific structures of redundant conduits 12 and corresponding accessories.

[0079] A first specific configuration of redundant conduits 12 .

[0080] like Figure 3 、 Figure 5 、 Figure 6 As shown, the redundant drainage structure of the redundant catheter 12 includes a plurality of drainage windows 122 arranged on the tube wall of the proximal section. The plurality of drainage windows 122 are arranged circumferentially and axially, thereby forming a plurality of circles of drainage windows 122 arranged axially. Each drainage window 122 includes two windows 1221, and a connecting rib 1222 is provided between the two windows 1221. The inner hole wall of the redundant catheter 12 and the area corresponding to each drainage window 122 are provided with a valve plate 40. The valve plate 40 can be obtained by cutting an elastic sheet component. The middle part of the valve plate 40 is attached and fixed to the connecting rib 1222, and the two sides of the valve plate 40 cover the two windows 1221. By rationally configuring the structure and material of the valve plate 40 (for example, selecting a sheet component with a suitable elastic modulus), the valve plate 40 is deformed radially inward when the pressure outside the redundant catheter 12 rises to the set pressure of the cerebrospinal fluid, thereby opening the window 1221. In this way, when the pressure of the cerebrospinal fluid in the ventricle 300 is higher than the set pressure, the cerebrospinal fluid automatically enters the central cavity 121 of the redundant catheter 12 and then enters the confluence cavity 23, thereby realizing automatic drainage. When the pressure of the cerebrospinal fluid in the ventricle 300 is lower than the set pressure, the valve plate 40 closes the window 1221, thereby limiting drainage through the redundant catheter 12.

[0081] In some preferred configurations, a spacer 13 is provided between the innermost microcatheter 11 and the redundant catheter 12. The wall of the spacer 13 is composed of a mesh. The spacer 13 is used to intercept (or filter) protein fragments and larger protein (hemagglutination) particles. The purpose of the spacer 13 is to: if the window 1221 of the drainage window 122 is configured to be smaller, it will increase the difficulty of processing and installing the valve disc 40 and increase the difficulty of controlling the deformation timing of the valve disc 40 during testing. Therefore, the window 1221 needs to be larger. A larger window 1221 can cause protein fragments and protein (hemagglutination) particles to enter the central lumen 121, the confluence lumen 23, and the diversion hose 200, potentially blocking the diversion hose 200 and the control valve thereon, especially the control valve. Therefore, by configuring the spacer 13 composed of a mesh structure, protein fragments and larger particles are intercepted, thereby effectively reducing the probability of blockage of the diversion hose 200 and the control valve.

[0082] In some preferred structures, a rib 123 is arranged on the cylindrical surface of the redundant catheter 12 between each two adjacent circles of drainage windows 122. The rib 123 has grooves 1231 arranged circumferentially and axially extending therethrough. The rib 123 is used to separate the inner wall of the spacer 13 from the cylindrical surface, which is conducive to the smooth collection of cerebrospinal fluid around the redundant catheter 12 and entering the central cavity 121 through the drainage windows 122. The grooves 1231 enable the cerebrospinal fluid to communicate with each other in the axial direction.

[0083] It is necessary to introduce the manufacturing method of the redundant conduit 12 below.

[0084] like Figure 7 and Figure 8 As shown, the main body of the redundant catheter 12 is formed by rolling a thin strip 400 made of a high molecular polymer with good biocompatibility. Before rolling, the drainage windows 122 arranged in a matrix and having two windows 1221 and connecting ribs 1222 are cut or carved on the thin strip 400. In addition, before rolling, the valve sheet 40 is adhered to the connecting rib 1222 of the drainage window 122 on the inner side of the thin plate strip 400. Specifically, first, a silicone plate (sheet) with elastic strips 41 arranged at intervals (the elastic strips 41 are used to provide a certain elastic deformation stiffness for the cut valve sheet 40, and the elastic deformation timing of the valve sheet 40 can be regulated by controlling the material, thickness, width and arrangement density of the elastic strips 41) is attached to the back to cut out valve sheets 40 arranged in a matrix and corresponding to the drainage windows 122 on the thin plate strip 400 and connected to each other. Then, the valve sheets 40 arranged in the matrix are aligned with the drainage windows 122 arranged in a rectangular manner and covered accordingly. The middle part of the valve sheet 40 can be attached and fixed to the connecting rib 1222 at the drainage window 122 by gluing or other means. After attachment and fixation, the connecting strip connecting the valve sheet 40 is cut off. Before rolling, strip-shaped components are bonded to the outside of the thin plate strip 400 at intervals, thereby forming the ribs 123 on the outside of the redundant conduit 12 after rolling.

[0085] The redundant conduit 12 of the above structure has the following advantages:

[0086] The valve disc 40 directly responds to the pressure of the cerebrospinal fluid in the ventricle 300 increasing to a set pressure and opens the drainage window 122 to implement drainage.

[0087] The second specific structure has redundant conduits 12 .

[0088] like Figure 9As shown, the redundant drainage structure of the redundant catheter 12 comprises circular or quasi-circular micropores 124 formed on the distal end of the redundant catheter 12 and distributed throughout the catheter wall. Furthermore, a check valve 50 is disposed at the port 25 where the distal end of the redundant catheter 12 meets the bottom of the confluence lumen 23. By opening the port 25, the check valve 50 allows cerebrospinal fluid within the central lumen 121 to flow into the confluence lumen 23, but restricts the flow of cerebrospinal fluid from the confluence lumen 23 to the central lumen 121. The opening pressure of the check valve 50 is limited to the aforementioned set pressure. Thus, when the pressure of the cerebrospinal fluid within the ventricle 300 exceeds the set pressure, this pressure is transmitted through the micropores 124 and the central lumen 121 to the check valve 50, causing it to open, thereby allowing cerebrospinal fluid to continue flowing through the micropores 124 and the central lumen 121 to the confluence lumen 23.

[0089] It should be noted that when the check valve 50 is in the closed state, there is no pressure difference between the cerebrospinal fluid in the central cavity 121 and the cerebrospinal fluid outside the redundant catheter 12. Therefore, the cerebrospinal fluid outside the redundant catheter 12 will not flow toward the micropore 124, nor will it have a tendency to flow toward the micropore 124. Therefore, before the drainage of the microcatheter 11 fails, since the cerebrospinal fluid basically will not flow toward the micropore 124 or have a tendency to flow, the possibility of the micropore 124 being blocked is low. Even if protein particles are present in the micropore 124, the stability of the protein particle aggregation is poor.

[0090] In some preferred structures, the check valve 50 includes a circular plate 51 mounted at the port 25 at the bottom of the confluence chamber 23 and having a plurality of circumferentially arranged valve ports 511, and a circular silicone sheet 52 disposed on the circular plate 51 and blocking the valve ports 511 (an elastic strip 41 is attached and fixed to the rear side of the circular silicone sheet 52 to provide elastic deformation stiffness). The middle portion of the circular silicone sheet 52 is attached and fixed to the middle portion of the circular plate 51. In this way, the edge of the circular silicone sheet 52 elastically deforms in response to the pressure of the cerebrospinal fluid in the central cavity 121, thereby opening the valve ports 511, thereby allowing the cerebrospinal fluid to enter the confluence chamber 23 through the valve ports 511. Preferably, the pressure of the cerebrospinal fluid that causes the elastic deformation of the circular silicone sheet 52 is set to be lower than the pressure of the cerebrospinal fluid that causes the elastic deformation of the valve disc 40.

[0091] In some preferred structures, a liquid inlet connector 242 connected to the confluence chamber 23 is also provided on the base 20. Preferably, the liquid inlet connector 242 is located on the side of the base 20 and extends radially. The liquid inlet connector 242 is arranged in parallel with the liquid outlet connector 241. In the device provided with the first redundant catheter 12, a check valve 60 is also installed at the port 25 where the redundant catheter 12 and the lower cavity of the confluence chamber 23 intersect. The check valve 60 allows cerebrospinal fluid to flow from the central cavity 121 to the confluence chamber 23 while restricting the cerebrospinal fluid from flowing from the confluence chamber 23 to the central cavity 121. The check valve 60 is configured to have an extremely small opening pressure, which is much smaller than the opening pressure of the check valve 60 on the proximal side of the second redundant catheter 12 mentioned above. Preferably, a duckbill one-way valve made of silicone is selected as the check valve 60. In this way, during drainage, the liquid inlet connector 242 is in a closed state. If it is necessary to administer liquids such as medication or physiological cleaning fluids into the ventricle 300, the liquid outlet connector 241 is closed and the liquid inlet connector 242 is opened. The liquid enters the confluence cavity 23 through the liquid inlet connector 242. The check valves 50 and 60 at the bottom of the confluence cavity 23 restrict the liquid from flowing into the central cavity 121, so that the liquid can only flow into the micro-center hole 111 of the microcatheter 11 through the proximal end of the microcatheter 11, and then flow into the ventricle 300 through the microdrainage structure on the microcatheter 11, thereby achieving the purpose of administering medication and reverse cleaning the micro-guiding structure.

[0092] In some preferred structures, a visual window 26 is configured at the top of the confluence chamber 23. For example, the visual window 26 is obtained by configuring the cover plate covering the top of the confluence chamber 23 into a transparent structure. The significant function of the visual window 26 is that the opening and closing status of the check valves 50 and 60 can be visually observed. If the check valves 50 and 60 are in the open state, it means that the redundant catheter 12 has participated in the drainage, which indicates that the microcatheter 11 may have failed in drainage or is close to failure in drainage.

[0093] In addition, although exemplary embodiments have been described in the present invention, the scope includes any and all embodiments based on the present invention with equivalent elements, modifications, omissions, combinations (e.g., solutions that intersect various embodiments), adaptations, or changes. The elements in the claims are to be interpreted broadly based on the language used in the claims and are not limited to the examples described in this specification or during the prosecution of this application, which examples are to be interpreted as non-exclusive. Therefore, this specification and examples are intended to be considered as examples only, and the true scope and spirit are indicated by the following claims and the full scope of their equivalents.

[0094] The above description is intended to be illustrative and not restrictive. For example, the above examples (or one or more of their solutions) can be used in combination with each other. For example, a person of ordinary skill in the art may use other embodiments when reading the above description. In addition, in the above-mentioned specific embodiments, various features can be grouped together to simplify the present invention. This should not be interpreted as an intention that a disclosed feature that is not required to be protected is necessary for any claim. On the contrary, the subject matter of the present invention may be less than all the features of a specific disclosed embodiment. Thus, the following claims are incorporated into the specific embodiments as examples or embodiments, wherein each claim is independently a separate embodiment, and it is considered that these embodiments can be combined with each other in various combinations or arrangements. The scope of the present invention should be determined with reference to the appended claims and the full scope of equivalents to which these claims are entitled.

[0095] The above embodiments are merely exemplary embodiments of the present invention and are not intended to limit the scope of the present invention. The scope of protection of the present invention is defined by the claims. Those skilled in the art may make various modifications or equivalent substitutions to the present invention within the spirit and scope of protection of the present invention, and such modifications or equivalent substitutions shall also be deemed to fall within the scope of protection of the present invention.

Claims

1. A drainage device for intraventricular hydrops, characterized in that: include: A base, which is used to be attached to the bone window of the skull, wherein the base is provided with a confluence cavity and a liquid outlet connector communicating with the confluence cavity, and a diversion hose is connected to the liquid outlet connector; a tip axially distal from the base; The drainage main body component is used to guide the cerebrospinal fluid in the ventricle to the confluence cavity; wherein: The drainage main body component includes a plurality of microcatheters; the proximal end and distal end of each microcatheter are attached to the base and the end head respectively, and the micro-center hole of each microcatheter is connected to the confluence cavity at the proximal end; all the microcatheters are arranged in multiple circles along the circumferential direction and the radial direction; The wall of each microcatheter is provided with a microdrainage structure penetrating the microcentral hole. The microdrainage structure is arranged circumferentially and axially along the wall of the microcatheter to allow cerebrospinal fluid to enter the microcentral hole through the wall of the microcatheter.

2. The intraventricular hydrocele drainage device according to claim 1, characterized in that: The micro-drainage structure includes a plurality of linear slit-shaped holes; the plurality of linear slit-shaped holes are arranged on the wall of the micro-catheter along the circumferential direction and the axial direction; wherein: Each linear slit hole extends along the axial direction of the microcatheter, and the width of each linear slit hole increases from the distal end to the proximal end of the microcatheter, and the maximum width of the linear slit hole is smaller than the diameter of the microcenter hole.

3. The intraventricular hydrocele drainage device according to claim 1, characterized in that: The micro-drainage structure is a spiral slit formed on the micro-catheter and extending in a spiral direction. The width of the spiral slit is smaller than the diameter of the micro-center hole.

4. The intraventricular hydrocele drainage device according to claim 1, characterized in that: The drainage main body component further includes a redundant catheter, which is located in the central area of ​​the columnar space enclosed by the plurality of microcatheters; The redundant catheter defines a central lumen, the proximal end and the distal end of the redundant catheter are attached to the base and the tip, respectively, and the central lumen is connected to the confluence lumen at the proximal end; a redundant drainage structure is configured on the wall of the redundant catheter and is in communication with the central lumen, and the redundant drainage structure can allow cerebrospinal fluid to enter the central lumen so that the redundant catheter can guide the cerebrospinal fluid to the confluence lumen; wherein: The drainage timing of the redundant catheter is configured so that after the pressure in the ventricle is greater than the set pressure, cerebrospinal fluid is allowed to enter the confluence cavity through the redundant drainage structure and the central cavity.

5. The intraventricular hydrocele drainage device according to claim 4, characterized in that: The redundant drainage structure includes a plurality of drainage windows disposed on the wall of the redundant catheter, wherein the plurality of drainage windows are arranged circumferentially and axially; wherein: The inner hole wall of the redundant catheter and the area corresponding to each drainage window are each provided with a valve plate. In response to the pressure of the cerebrospinal fluid rising to be greater than the set pressure, the valve plate opens the drainage window through elastic deformation forced by the pressure, and closes the drainage window through elastic resetting.

6. The intraventricular hydrocele drainage device according to claim 5, characterized in that: A mesh spacer is provided between the redundant catheter and the micro-catheter of the inner circle; The outer circumference of the redundant conduit is configured with a plurality of ribs arranged at intervals along the axial direction, each rib having a circumferentially arranged and axially penetrating groove; the ribs separate the grid spacer from the outer circumference of the redundant conduit.

7. The intraventricular hydrocele drainage device according to claim 4, characterized in that: The redundant drainage structure includes a plurality of micropores arranged on the wall of the redundant catheter; wherein: A check valve component is installed at the intersection of the confluence cavity of the base and the central cavity of the redundant catheter. The check valve component allows cerebrospinal fluid to flow from the central cavity to the confluence cavity while restricting reverse flow. In addition, the check valve component has an opening pressure that allows cerebrospinal fluid to flow from the central cavity to the confluence cavity.

8. The intraventricular hydrocele drainage device according to claim 5, characterized in that: A check valve component is installed at the intersection of the confluence cavity of the base and the central hole of the redundant catheter. The check valve component allows cerebrospinal fluid to flow from the central cavity to the confluence cavity and restricts reverse flow.

9. The intraventricular hydrocele drainage device according to claim 4, characterized in that: A transparent observation window is provided at the top of the base in an area opposite to the confluence cavity.

10. The intraventricular hydrocele drainage device according to claim 7 or 8, characterized in that: The base is further provided with a liquid inlet and outlet joint, the liquid inlet joint is communicated with the confluence cavity, the liquid inlet joint and the liquid outlet joint both extend radially and are arranged in parallel with the liquid inlet joint.

11. The intraventricular hydrocele drainage device according to claim 2, characterized in that: The linear slit-shaped holes on the microcatheter are formed by cutting with a micro knife or by laser engraving.

12. The intraventricular hydrocele drainage device according to claim 3, characterized in that: The spiral seam on the microcatheter is formed by winding a strip around a core needle with spiral ribs and then thermoforming.

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