CN117282006A - Shunt and system for treating hydrocephalus - Google Patents
Shunt and system for treating hydrocephalus Download PDFInfo
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- CN117282006A CN117282006A CN202311579344.8A CN202311579344A CN117282006A CN 117282006 A CN117282006 A CN 117282006A CN 202311579344 A CN202311579344 A CN 202311579344A CN 117282006 A CN117282006 A CN 117282006A
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
- A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
- A61M27/006—Cerebrospinal drainage; Accessories therefor, e.g. valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/84—Drainage tubes; Aspiration tips
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/84—Drainage tubes; Aspiration tips
- A61M1/87—Details of the aspiration tip, not otherwise provided for
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
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- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
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- A—HUMAN NECESSITIES
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- A61M25/00—Catheters; Hollow probes
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- A61M25/0194—Tunnelling catheters
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- A—HUMAN NECESSITIES
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
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- A—HUMAN NECESSITIES
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- A61M25/00—Catheters; Hollow probes
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- A61M25/09—Guide wires
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- A—HUMAN NECESSITIES
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
Abstract
The present invention relates to the field of hydrocephalus treatment, and in particular to a shunt and system for treating hydrocephalus, the shunt configured for intravascular delivery and deployment in a patient's venous and ventricular systems, the shunt comprising: a distal portion and a physiologically responsive member comprised thereof, further comprising at least one fluid-permeable inlet, and a wrapping member, and a proximal portion, and a flexible body portion having a lumen, the distal portion extending through the flexible body portion to the proximal portion, wherein the lumen is in fluid communication with one or more inlets in the distal portion and with an outlet opening in the proximal portion; the diverting system includes a diverter and a delivery system. Under the condition of delivery or deployment without response, the physiological response component can not expand after being released, and can reach the expansion volume requirement only under the conditions of specific ph, ion concentration and the like.
Description
Technical Field
The invention relates to the field of hydrocephalus treatment, in particular to a shunt and a system for treating hydrocephalus.
Background
Hydrocephalus is one of the most common and important neurosurgical diseases affecting children and adults. Hydrocephalus, meaning "water in the brain," refers to abnormal accumulation of cerebrospinal fluid (CSF for short) in the brain. Excessive intracranial pressure caused by hydrocephalus can lead to a number of obvious symptoms ranging from headache to neurological dysfunction, coma and death. Cerebrospinal fluid is a transparent physiological fluid in which the entire nervous system (including the brain and spinal cord) is immersed. Cells of the choroid plexus present in the brain chamber produce CSF. In normal patients, cells within the arachnoid granules reabsorb CSF produced in the choroid plexus. The arachnoid particles span the surface of the intracranial venous drainage system of the brain and reabsorption of CSF present in the subarachnoid space into the venous system. CSF of about 450mL to 500mL is produced and reabsorbed daily, enabling a steady state volume and pressure of about 8-16cm h2o to be produced in the intracranial ventricle. This re-absorption pathway has been termed the "third cycle" because of its importance to the homeostasis of the central nervous system.
Hydrocephalus most commonly occurs due to impaired reabsorption of CSF, and sometimes also due to its hypersecretion. A condition of impaired reabsorption is called communicating hydrocephalus. Hydrocephalus can also occur due to partial or complete blockage of one of the CSF pathways (e.g., the celer brain water guide tube), which results in a disease known as obstructive hydrocephalus. Atmospheric hydrocephalus (NPH) is a form of traffic hydrocephalus. Unlike other forms of communicating hydrocephalus, NPH patients may exhibit little or no increase in intracranial pressure. It is believed that in NPH patients, the CSF-filled ventricles in the brain will enlarge to accommodate the increased CSF volume in the subarachnoid space.
In recent years, a therapeutic approach for the shunt of cerebral fluid through percutaneous/vascular intervention has been proposed. A specific treatment approach is to deploy shunts in the subpetrous sinus (IPS) and the cerebellar pontic angle pool of the patient. Specifically, a distal portion of the shunt is introduced via the IPS and secured within a cerebral bridgehead (CP) angle cistern of the patient, the CP angle cistern containing cerebrospinal fluid (CSF); a shunt proximal portion secured within or adjacent to the Jugular Vein (JV) of the patient; CSF flows from the CP angle cistern into the JV through the flow passage of the shunt to maintain a normal pressure differential between the patient's subarachnoid space and venous system.
The shunt tubes of the technical schemes such as CN107148293B realize the delivery by a distal anchoring mechanism which is automatically expanded through folding delivery, and the delivery mode radially constrains the distal anchoring mechanism which is automatically expanded by utilizing the physical space structure of an outer sleeve or a casing tube such as an external delivery catheter, a protective sleeve and the like. In the conveying mode, the distal anchoring mechanism has certain radial pressure and friction force on an external conveying catheter, a protective sleeve and the like, and meanwhile, the conveying catheter and/or the protective sleeve and the distal anchoring mechanism can be twisted, bent, moved and the like relatively due to the tortuosity and the bending of a blood vessel, and the contact surface of the conveying catheter and the protective sleeve is damaged by the distal anchoring mechanism under the action of the elastic force of the distal anchoring mechanism; at the same time, the internal support of the delivery catheter and/or the protective sheath by the distal anchoring mechanism can affect the delivery capability of the delivery catheter itself.
Disclosure of Invention
In order to solve the technical problems, the invention aims to provide a shunt and a system for treating hydrocephalus, and fixation of the shunt is realized through environmental response so as to solve the defects of high infection risk and the like of the existing shunt.
A distal portion comprising a physiologically responsive member configured for introduction via the venous system and placement within a brain cell of a patient, the physiologically responsive member of the distal portion being expandable or settable under conditions of a cerebrospinal fluid physiological environment to effect fixation of the distal portion within the brain cell, upon or after deployment of the distal portion within the brain cell of a patient, and at least one fluid-pervious inlet; and a proximal portion configured for placement in a patient's venous system, the proximal portion having an outlet for fluid outflow; and a flexible body portion having a lumen extending therethrough to the proximal portion, wherein the lumen is in fluid communication with one or more inlets in the distal portion and with an outlet in the proximal portion such that when the shunt is deployed in the venous system and the distal portion of the shunt is disposed within the brain pool and the proximal portion of the shunt is disposed in the venous system, cerebrospinal fluid flows from the brain pool into the venous system through the one or more inlets, the lumen of the shunt, and the outlet, respectively.
Further, a controlled flow configuration is provided within the lumen of the flexible body portion or outside the inlet of the distal portion or outside the outlet of the proximal portion that only allows fluid to flow from the distal portion of the shunt into the proximal portion of the shunt.
Further, the control flow direction is configured as a one-way valve, a one-way flow surface, a one-way flow channel.
Further, the physiologically responsive member is a non-mechanical environmentally responsive inflation member that swells or solidifies or sets in response to conditions of the cerebrospinal fluid physiological environment.
Further, the physiological environment is conditioned by one or more of cerebrospinal fluid specific ingredients, temperature, pH or ion concentration.
Further, the physiological environment is an aqueous solution at a temperature of 35-43 ℃ and a pH:7.0-7.4, glucose concentration: 2.8-5.0mmol/L, chloride concentration: 110-132mmol/L or a mixture.
Further, the physiologically responsive member comprises a super absorbent resin, a water absorbent silica gel, a hydrogel, a water absorbent rubber, a shape memory alloy, or a combination thereof.
Further, the hydrogel includes a water-absorbing responsive hydrogel, a temperature-sensitive hydrogel, a specific ion/component responsive hydrogel, a body fluid responsive crosslinked hydrogel, or a combination thereof.
Further, the shape memory alloy phase transition temperature of the physiologically responsive member is less than or equal to the physiological environment temperature of the cerebrospinal fluid for deployment.
Further, a wrapping member for partially or completely wrapping the physiologically responsive member is fixed to the distal portion of the tube wall.
Further, the wrapping member is a porous membrane structure having a pore size not larger than a particle diameter of the physiological response member.
Further, a deformation member is arranged outside the physiological response member and used for limiting the expansion range of the physiological response member.
Further, shielding and protecting structures are arranged on the outer side of the physiological response component and used for short-term isolation of blood or physiological response environmental conditions for the physiological response component.
Further, shielding and protecting structures are arranged on the outer side of the physiological response component and used for short-term isolation of blood or physiological response to environmental conditions.
Further, a shielding and protecting device is arranged at the proximal end part of the shunt and is used for isolating endothelial cells of a venous system from an outlet of the proximal end part of the shunt;
and/or a semipermeable membrane is arranged in the cavity of the shunt flexible body part or outside the inlet of the distal end part or outside the outlet of the proximal end part, and is used for limiting the flow, diffusion and exchange of partial components in the brain cell and the venous system;
And/or an inner polymer liner or anticoagulant layer is provided within the lumen of the shunt flexible body portion, the inner polymer liner or anticoagulant layer extending at least halfway between the distal end portion and the proximal end portion;
and/or the shunt outer surface is at least partially provided with an inner polymer liner or anticoagulant layer.
The invention also discloses an environmental response shunt system for treating hydrocephalus, the system comprising: the diverter, and a delivery system; the conveying system includes: the device comprises a puncture member, a guide member and a conveying member, wherein the conveying member comprises a conveying catheter with a cavity, a conveying distal end and a conveying proximal end which are positioned at the far end and the near end of the conveying catheter and used for conveying, and the cavity is used for accommodating and conveying the shunt to a brain pool; the guide member is arranged in the conveying guide pipe in a penetrating way and is used for guiding the conveying member to move; the puncture member is positioned in the cavity of the delivery catheter or is connected with the distal end of the delivery catheter, and the distal end of the puncture member is provided with a puncture tip for forming an anastomotic passage between the venous system and the ventricular system through the puncture tip.
Further, the guide member comprises an elongated guide member penetrating within the delivery catheter and an anchoring member for anchoring outside the delivery catheter, the distal end of the elongated guide member being connected to the anchoring member; the shunt is placed within the piercing member cavity or the piercing member is placed within the shunt; or the puncture member is positioned outside the outer side surface of the shunt portion, and the shunt is positioned in the delivery member cavity.
Further, the delivery system also includes a diverter push rod positioned within the delivery catheter lumen for clamping, pushing, pulling or limiting the diverter.
Further, the guide member comprises one or a combination of a guidewire, a distal shapeable microcatheter, a guide catheter, a catheter with a single-sided balloon, a stent or balloon with a lumen, a contrast catheter, a stent with a guidewire, and the like.
Further, the shunt system is provided with one or more radiopaque markers.
Further, an operating handle is connected to a part or all of the proximal ends of the components of the delivery system.
Further, the delivery system is provided with a shielded protective delivery configuration for short-term isolation of blood or physiologically responsive environmental conditions for the shunt.
Further, the shielding protection conveying structure is a temperature control member, and the temperature control member is arranged outside or inside the conveying conduit and used for controlling the temperature in the conveying conduit.
Further, the temperature control member comprises a fixing piece and a medium conveying pipe; one end of the medium conveying pipe is arranged in the conveying pipe cavity through the fixing piece or one end of the medium conveying pipe extends from the outer side of the conveying pipe to the conveying distal end through the fixing piece, the other end of the medium conveying pipe extends out of the conveying pipe cavity to form a medium conveying cavity for conveying a medium, the fixing piece is positioned at the conveying proximal end, and the fixing piece proximal end and the conveying proximal end opening form an instrument conveying cavity for conveying an instrument.
Further, a temperature sensor is arranged in the temperature control component and is used for detecting the temperature of the conveying system.
Compared with the prior art, the invention has the beneficial effects that: the invention realizes the fixation of the distal end part in the brain pool by arranging the physiological response component to respond to expansion or solidification or setting only in the physiological environment of cerebrospinal fluid. Namely, the physiological response component is not mechanically responded, is made of a specific material, generates expansion response after being stimulated in the environment with specific conditions, does not generate expansion after being released in the environment without response conditions, and can only meet the expansion volume requirement under the conditions of specific ph, ion concentration and the like; the scheme of the invention is an application innovation of materials, and optimizes the expansion deployment structure of the distal end part of the shunt tube and the shunt system.
Compared with the existing distal end of the shunt, the distal end of the shunt reduces extrusion and friction of a conveying catheter in the conveying process, and is convenient to convey and deploy. Meanwhile, the shunt has better elasticity, larger volume and larger contact area, is softer, does not cause puncture damage and additional risk to brain tissues, has the density similar to that of cerebrospinal fluid, has large contact area with dura mater, can be more adhered to the surface of the dura mater, does not generate excessive pressure to the dura mater near an anastomotic stoma, does not generate additional stress concentration to the anastomotic stoma, and reduces tearing risk.
Drawings
FIG. 1 is a block diagram of a shunt for treating hydrocephalus according to the present invention;
FIG. 2 is a block diagram of another embodiment of a shunt for treating hydrocephalus according to the present invention;
FIG. 3 is a cross-sectional view of an environmental responsive shunt system for treating hydrocephalus in accordance with the present invention;
fig. 4 is a block diagram of a temperature control member of an environmentally responsive shunt system for treating hydrocephalus in accordance with the present invention.
In the figure: 1-anchoring member, 2-elongate guiding member, 3-distal portion, 4-piercing member, 5-delivery catheter, 6-flexible body portion, 7-proximal portion, 8-shunt push rod, 9-media delivery tube, 10-media delivery inlet, 11-temperature control member, 20-media delivery lumen, 21-instrument delivery lumen, 30-controlled flow configuration, 31-wrapping member, 32-inlet, 33-distal portion tube wall, 34-physiologically responsive member, 35-deforming member.
Detailed Description
In order to describe the technical content, constructional features, achieved objects and effects of the present invention in detail, the following examples are given by way of example and are described in detail with reference to the accompanying drawings.
In the description of the present invention, it should be understood that the terms "center," "longitudinal," "lateral," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, merely to facilitate describing the present invention and simplify the description, and do not indicate or imply that the devices or elements being referred to must have a specific orientation, be configured and operated in a specific orientation, and therefore should not be construed as limiting the scope of the present invention.
Example 1
Referring to fig. 1, 2 and 3, the present invention provides a shunt for treating hydrocephalus configured for intravascular delivery and deployment in a venous system and ventricle system of a patient, the shunt comprising: a distal portion 3, said distal portion 3 comprising a physiologically responsive member 34 configured for introduction via the venous system (in particular the inferior rock sinus) and for placement within a brain pool (in particular the small pontic brain angle pool) of a patient, said physiologically responsive member 34 of the distal portion 3 being expandable or settable under conditions of the physiological environment of cerebrospinal fluid to effect fixation of the distal portion 3 within the brain pool, and at least one fluid-permeable inlet 32; and a proximal portion 7 configured for placement in a patient's venous system (primarily in or near the jugular vein), said proximal portion 7 being provided with an outlet for fluid outflow; and a flexible body portion 6 having a lumen, the distal portion 3 extending through the flexible body portion 6 to the proximal portion 7, wherein the lumen is in fluid communication with one or more inlets 32 in the distal portion 3 and with an outlet in the proximal portion 7, such that when the shunt is deployed in the venous system and the distal portion 3 of the shunt is disposed within the brain pool and the proximal portion 7 of the shunt is disposed within or near the jugular vein, cerebrospinal fluid flows from the brain pool into the venous system (primarily the jugular vein) through the one or more inlets 32, the lumen of the shunt, and the outlet, respectively.
Wherein the physiologically responsive member 34 is a non-mechanical environmentally responsive expansion member that expands, solidifies, sets, etc. upon response to physiological environmental conditions of cerebrospinal fluid, thereby securing or restraining the distal portion 3 of the shunt to the cerebellar angle cisterna side, including, but not limited to, super absorbent resins, hydroscopic silicone (rubber) gels, (sensitive to composition, temperature, ionic concentration, etc.) hydrogels, water-absorbent rubbers, shape memory alloys, etc.; after the distal portion 3 is deployed within the brain pool of the patient, the non-mechanically responsive expansion member of the distal portion 3 may be expanded or coagulated under physiological conditions of cerebrospinal fluid to effect fixation of the distal portion 3 within the brain pool, including, but not limited to, one or more of specific components of cerebrospinal fluid, temperature, pH, or ion concentration.
Further, specific components of the physiological environment include, but are not limited to, one or a mixture of water, glucose, albumin, proteins such as immunoglobulins, enzymes such as transaminases, lactate dehydrogenase, chlorides, HCO 3-plasma; further, the physiological environment is an aqueous solution at a temperature of 35-43 ℃ and a pH:7.0-7.4, glucose concentration: 2.8-5.0mmol/L, chloride concentration: 110-132mmol/L or a mixture thereof; further, the water-absorbent resin includes, but is not limited to, polyacrylic acid series and polyvinyl alcohol series, such as sodium polyacrylate, polyvinyl alcohol-acrylate copolymer super absorbent resin, etc.; further, the hydrogels are configured to undergo swelling, clotting, etc. responses under cerebrospinal fluid environmental conditions, including, but not limited to, water-absorbing responsive hydrogels, temperature-sensitive hydrogels, specific ion-responsive hydrogels, body fluid-responsive crosslinked hydrogels (powders), etc.; under normal conditions, the non-mechanical environment response expansion member will not self-expand after being released, but will respond under physiological environment conditions to expand or solidify or set, for example, after the hydrogel structure in the non-mechanical environment response expansion member absorbs cerebrospinal fluid in the cerebellar horn cell, the water-absorbing material in the hydrogel structure can absorb the water in the hydrogel structure, meanwhile, due to the specific PH and ion concentration in the cerebrospinal fluid, the non-mechanical environment response expansion member will release, and then self-expand to reach a certain volume requirement, and in non-cerebrospinal fluid environments, such as blood environment, the water-absorbing resin has weak water absorption capacity and cannot reach the expansion volume requirement. Other non-mechanical environmentally responsive expansion members, which are also based on this principle, can only meet the expansion volume requirement under certain environmental conditions, and thus do not reach the brain pool and do not meet the expansion volume requirement under certain environmental conditions.
Further, the shape memory alloy phase transition temperature is less than or equal to a physiological environment temperature of the cerebrospinal fluid for deployment.
Further, a semipermeable membrane is provided within the lumen of the shunt flexible body portion 6 or outside the inlet 32 of the distal portion 3 or outside the outlet of the proximal portion 7 for restricting the flow, diffusion, exchange of a portion of the components in the brain pool and venous system.
Further, a wrap member 31 is secured to the distal portion wall 33, and the wrap material is secured to the shunt distal portion wall 33 and is configured to partially or completely wrap the non-mechanically responsive expansion responsive member; thereby ensuring that the wrap member 31 is able to secure the non-mechanically responsive expansion responsive member to the outer wall of the distal portion 3 of the shunt.
Further, the wrapping member 31 is a porous membrane structure including, but not limited to, a porous PTFE membrane; further, the pore diameter of the porous membrane structure is smaller than or equal to the particle diameter of the non-mechanical response expansion member; since the pore diameter of the porous PTFE membrane (e.g., pore diameter 15 μm, thickness 0.01 to 0.05 μm) is equal to or smaller than the particle diameter of the super absorbent resin (e.g., sodium polyacrylate, 500 mesh, 25 μm). After the distal end part 3 of the shunt is conveyed to the brain pool through the conveying system, cerebrospinal fluid enters the membrane through the holes on the PTFE porous membrane, and the superabsorbent resin absorbs the cerebrospinal fluid to expand and gradually fills the membrane cavity (can expand continuously to expand the membrane), so that the distal end of the shunt with a certain volume is formed, and the distal end of the shunt can be fixed and limited on the brain pool side.
Further, a controlled flow configuration 30 is provided within the lumen of the flexible body portion 6 (either outside the inlet 32 of the distal portion 3 or outside the outlet of the proximal portion 7) which only allows fluid to flow from the distal portion 3 of the shunt into the proximal portion of the shunt. That is, during operation, cerebrospinal fluid is allowed to flow from the brain pool through the lumen of the shunt into the jugular vein, and conversely, flow is not allowed, in practice, the flow control mechanism 30 may employ a one-way valve (e.g., duckbill valve, diaphragm valve, double-diaphragm flap valve, single-diaphragm flap valve, spring valve), a one-way flow surface (e.g., a one-way flow microstructure (e.g., a sub-millimeter three-dimensional capillary saw tooth structure), a hydrophilic-hydrophobic alternating structure, a one-way damping surface structure), a one-way flow channel (e.g., a tesla valve), or other similar means for achieving such protection. In other embodiments, the flow control member may also be disposed outside the lumen of the flexible body portion 6, such as outside the inlet 32 of the distal portion 3 or outside the outlet of the proximal portion 7, as may be accomplished to allow fluid flow only from the distal portion 3 into the proximal portion 7 of the shunt.
Preferably, said control flow formation 30 is placed in said proximal portion 7 of the shunt.
Further, a blood shielding protective structure is provided outside the physiologically responsive member 34 for short-term blood isolation of the physiologically responsive member 34 so that the physiologically responsive member 34 avoids swelling, clotting, or setting of the response during delivery and when no response is desired. Wherein the blood shielding protective structure may be a film, coating or other similar article that can achieve this protection.
Further, the proximal portion 7 of the shunt is provided with shielding protection means for isolating endothelial cells of the venous system from the outlet of the shunt tube of the proximal portion 7. Wherein the shielding protection device is a bracket, a balloon or other similar components capable of realizing the protection function.
Further, an inner polymer liner or anticoagulant layer is provided within the lumen of the shunt flexible body portion 6, the inner polymer liner or anticoagulant layer extending at least halfway between the distal and proximal end portions; and/or the shunt outer surface is at least partially provided with an inner polymer liner or anticoagulant layer. The liner is selected to be a material that minimizes protein and/or cell adhesion. The anticoagulant layer may be a coating, composition, component or other similar component that provides anticoagulant function on the exterior and interior surfaces of the shunt.
The invention also includes an environmental response shunt system for treating hydrocephalus, the system comprising: the diverter described above and the delivery system; the conveying system includes: a piercing member 4, a guide member, and a delivery member, wherein the delivery member comprises a delivery catheter 5 having a lumen for receiving and delivering a shunt to the brain pool, and a delivery distal end and a delivery proximal end at the distal and proximal ends of the delivery catheter 5 for delivery; the puncture member 4 is positioned in the cavity of the delivery catheter 5 or is connected with the distal end of the delivery catheter, and the distal end of the puncture member 4 is provided with a puncture tip for forming an anastomotic passage between a venous system and a ventricular system; the guiding member is arranged in the delivery catheter 5 in a penetrating way and used for guiding the delivery member to move towards the distal direction, and comprises an elongated guiding member 2 arranged in the delivery catheter 5 in a penetrating way and an anchoring member 1 used for anchoring the venous system outside the delivery catheter 5, wherein the distal end of the elongated guiding member 2 is connected with the anchoring member 1.
Specifically, the puncture member 4 may be a puncture catheter, the distal end of which is provided with a puncture tip, the puncture member being arranged in the delivery catheter in a penetrating manner, the shunt being arranged in the puncture catheter lumen or the puncture catheter being arranged in the shunt. In other embodiments, the piercing member may also be a piercing sheet disposed outside the outer side of the diverter portion and the separator is located within the delivery member cavity. Alternatively, the piercing member may be disposed directly at the distal end of the delivery catheter.
Further, the delivery catheter 5 may be configured as a dual lumen tube, where the two lumens are not in communication with each other, or are arranged in parallel, where one lumen has a relatively large volume, and may be used for placing the piercing member 4 and the shunt, and the other lumen has a relatively small volume, and may be used for placing the guiding member; and the shunt is placed in the cavity of the piercing member 4, the piercing member 4 may be passed through the cerebellum of the patient during operation, and the shunt may then be delivered to the cerebral pool (particularly the cerebellar angle pool) of the patient by the delivery system.
In other embodiments, the delivery catheter 5 may be provided as a single lumen or multiple lumens, one lumen may be used to house and deliver the guide member, piercing member, and shunt, or the guide member, piercing member, and shunt may be distributed in different lumens as desired, or even the delivery catheter may be provided with a lumen to house other components of the delivery system.
Further, the piercing member 4 comprises a piercing tip at a distal end and a body portion, which may be provided in a hypotube configuration at a distal end; the tip of the puncture member 4 comprises one of a bevel-edge needle, a Kunker-point needle, a half-edge needle, a willow-point needle, a pen-point needle, a radio frequency probe and the like; the guide member is located within one of the lumens of the delivery catheter 5, the guide member including, but not limited to, one or a combination of a guidewire, a distal shapeable microcatheter, a guide catheter, a catheter with a single-sided balloon, a stent or balloon with a lumen, a contrast catheter, a stent with a guidewire, and the like; further, the delivery system also includes a shunt pusher bar 8, the shunt pusher bar 8 abutting a proximally facing end surface of the shunt distal portion or a proximal or proximal portion of the physiologically responsive member, the shunt pusher bar being positioned within the lumen of the delivery catheter 5 for gripping, pushing, pulling or restraining the shunt, configured to deliver and/or deploy the shunt into the ventricular system.
Further, the shunt system includes one or more radiopaque markers that may be positioned at any desired location of the various components of the delivery system and/or the various components of the shunt for viewing by a physician or operator to indicate position or relative positional relationship or stability; further, the conveying system comprises an operating handle, wherein part or all of the proximal ends of conveying system components are connected to the operating handle, and the conveying system is operated through the operating handle; for example, an operating handle may be connected to the delivery catheter 5 to control the movement of the delivery system.
Further, the delivery system is also provided with a shielding protective delivery configuration for short-term isolation of blood or physiological response environmental conditions for the shunt. When the shielding and protecting structure is arranged outside the physiological response component, the conveying system can be provided with the shielding and protecting conveying structure according to the requirement, and when the shielding and protecting structure is not arranged outside the physiological response component, if the shunt can contact physiological response environment conditions triggering response in the conveying process, the conveying system must be provided with the shielding and protecting conveying structure to ensure isolation of the physiological response environment conditions in the conveying process. The shielding protection delivery configuration may be disposed outside of the delivery system or within the delivery system, as desired.
Example two
As shown in fig. 1, 2 and 3, a shunt for treating hydrocephalus according to the first embodiment is described, on the basis that a deformation member 35 may be installed outside the physiological response member 34, the deformation member 35 including a plurality of gaps along the expandable carrier member, the gaps allowing the physiological response member 34 to expand to a size greater than the inner diameter of the deformation member 35 or equal to the inner diameter of the deformation member 35 or smaller than the inner diameter of the deformation member 35 for limiting the expansion range of the physiological response member 34. For example, the deformation member 35 may be an elastic element (e.g., a spring coil) so as to prevent the non-mechanical environment from excessively expanding in response to the expansion member, and effectively control the expansion degree thereof, and prevent secondary injury to the small pontic angle pool caused by excessive expansion or secondary infection caused by rupture of the wrapping member 31 due to excessive expansion.
Example III
On the basis of the first and second embodiments, the present invention further proposes a shunt and a shunt system, as shown in fig. 1, 2, 3 and 4, in which a physiological response member 34 of the shunt is configured to be inflated to an inflated deployment configuration under the influence of a temperature in a physiological environment in which cerebrospinal fluid is deployed, the shunt comprising: a distal portion 3 configured for introduction via the venous system and placement in a ventricular system of the patient (in particular within a cerebellar horn pool, hereinafter referred to as a cerebellar horn pool) containing cerebrospinal fluid, wherein after deployment of the distal portion 3 within the cerebellar horn pool of the patient, the physiologically responsive member 34 swells from a delivery configuration in a delivery temperature environment to a swelled deployment configuration under the influence of temperature in a physiological environment in which cerebrospinal fluid is deployed; a proximal portion 7 configured for placement within or near the jugular vein of the patient; and a flexible body portion 6 having a lumen extending from the physiologically responsive member 34 to the proximal portion, wherein the lumen is in fluid communication with one or more cerebrospinal fluid inlets 32 in the distal portion 3 and with a cerebrospinal fluid outlet in the proximal portion 7, such that when the shunt is deployed in the inferior petrosal sinus and the physiologically responsive member 34 of the shunt is disposed within the small brain horn reservoir and the proximal portion 7 of the shunt is disposed within or near the jugular vein, cerebrospinal fluid flows from the small brain horn reservoir into the jugular vein through the one or more cerebrospinal fluid inlets 32, the lumen of the shunt, and the cerebrospinal fluid outlet, respectively.
Further, the physiologically responsive member 34 is in clearance fit with an adjacent delivery system member.
Further, the physiological response member 34 is a shape memory alloy such as nickel-titanium alloy, a temperature sensitive hydrogel, or the like.
When the nitinol transition is driven by a change in temperature, it is referred to as shape memory. Lowering the temperature below a certain limit (martensite start temperature Ms) results in the formation of martensite, thereby rendering the nitinol more ductile. When heated above the As temperature, the material begins to transform to the original austenite phase, begins to deform, and when heated above the Af temperature, the material transforms to the original austenite phase, thereby recovering its shape. The Af temperature can be adjusted by the material (alloy composition) or the manufacturing process of Nitinol.
Further, the shape memory alloy phase transition temperature of the physiologically responsive member 34 is less than or equal to the physiological environment temperature of the cerebrospinal fluid being deployed; further, the delivery temperature is below a shape memory alloy phase transition temperature; further, the nitinol physiologically responsive member 34, the deployment temperature is greater than or equal to an Af temperature; further, the nitinol physiologically responsive member 34 and similar shape memory alloy distal portion 3, the delivery temperature is preferably below As, and is sub-selected between As and Af.
Further, the nitinol physiologically responsive member 34 and similar shape memory alloy distal portion 3 are preformed to an expanded configuration when deployed above Af temperature and to an expanded configuration when the deployment is stretched or contracted below Ms temperature; further, the Af temperature range is 20-37 ℃; further, the As temperature range is 4-30 ℃; further, the shunt further comprises a one-way valve disposed within the lumen or otherwise coupled to the cerebrospinal fluid outlet, with a flow rate in the range of 5ml/hour to 15ml/hour under normal pressure differential conditions between the cerebellar bridge horn reservoir and venous system of the patient.
Further, the check valve opening pressure is 3mm Hg to 5mm Hg.
Further, the shunt, wherein the body portion (primarily within the lumen of the shunt flexible body portion 6) comprises an inner polymer liner extending at least halfway between the distal portion 3 and the proximal portion 7, and the liner defines at least a portion of the inner diameter of the lumen of the body portion and comprises a material selected to minimize protein and/or cell adhesion.
Further, the shunt is provided with a non-projection line mark.
The invention also proposes a system for treating hydrocephalus, the system comprising: a diverter according to the above; and a delivery system configured to introduce the shunt into the patient through a venous system access port such as a femoral vein and to guide the shunt into the inferior rock sinus of the patient. The conveying system comprises a temperature control member 11, a conveying member, a guiding member penetrating member 4 and the like. The temperature control component 11 is used for providing a low-temperature environment of the shunt, and can also form a tube sealing for the conveying system, so that the blood is prevented from entering, and the environmental conditions of isolating the blood and physiological response of the shunt in the conveying process are realized; the conveying component is used for conveying the components such as the shunt puncture component 4 and the like to a specified direction and position; the guiding means are used for guiding the direction and position of the conveying means and/or piercing means 4; the piercing member 4 is used to construct an anastomotic pathway between the dura mater (containing the arachnoid membrane) and the venous system;
the delivery system comprises a puncture member 4, a guiding member and a delivery member, wherein the delivery member comprises a temperature control member 11 with a cavity delivery catheter 5, and a distal delivery end and a proximal delivery end which are positioned at the distal end and the proximal end of the delivery catheter 5 for circulation;
The puncture member 4 is arranged at the distal end of the delivery catheter 5 and is connected with the distal end of the delivery catheter 5, and the puncture member 4 is internally provided with a cavity and is provided with a puncture tip at the distal end for enabling the venous system and the ventricle to form an anastomotic passage through the puncture tip;
a temperature control component 11 is fixedly arranged on the conveying conduit 5 and is used for controlling the temperature in the conveying conduit 5; the temperature control member 11 may also be movably connected to the delivery catheter 5. The temperature control component can be arranged on the outer side or the inner side of the conveying conduit according to the requirement, and can control the temperature in the conveying conduit.
Further, a temperature sensor is disposed in the temperature control member 11, for detecting the temperature of the conveying system.
A guide member is arranged in the conveying catheter 5 and comprises an elongated guide member 2 penetrating through the conveying catheter 5 and an anchoring member 1 used for anchoring outside the conveying catheter 5, and the distal end of the elongated guide member 2 is connected with the anchoring member 1; the shunt is arranged in the cavity of the puncture member 4 and the cavity of the delivery catheter 5.
The anchoring member 1 is anchored in the venous system to anchor the distal end of the elongate guiding member 2, the delivery catheter 5 and the piercing member 4 are moved distally along the elongate guiding member 2 from the proximal end, the piercing member 4 pierces the dura mater and the arachnoid membrane to form an anastomotic passageway, the shunt is pushed from within the delivery catheter 5 through the anastomotic passageway to the brain pool, the shunt is unresponsive in the delivery catheter 5 due to the temperature control member 11 maintaining a low temperature within the delivery catheter 5, the shunt is unresponsive to the physiologically responsive member 34, and after reaching the brain pool and pushing out the temperature controlled region of the temperature control member 11, the physiologically responsive member 34 at the distal end of the shunt leaves the temperature controlled environment and temperature responsive expansion effects deployment of the distal end of the shunt in the brain pool, the delivery catheter 5, piercing member 4, temperature control member 11, and guiding members and like delivery system members are withdrawn, the distal shunt portion 3 is deployed in the brain pool, the proximal shunt portion 7 is deployed in and near the jugular vein, and the shunt can expel cerebral spinal fluid in the brain pool to and near the jugular vein through the inlet, lumen, the outlet of the flexible body portion 6.
The anchoring member 1 may be provided as a stent, balloon or the like which may enable distal anchoring.
The temperature control member 11 comprises a fixing piece sleeved on the outer wall of the conveying member and a medium conveying pipe 9; one end of the medium conveying pipe 9 is arranged in the cavity of the conveying pipe 5 through the fixing piece, the other end of the medium conveying pipe extends out of the cavity of the conveying pipe 5 to form a medium conveying cavity 20 for conveying a medium, and a cooling medium can enter the cavity of the conveying pipe 5 through the medium conveying pipe 9 to be cooled, so that the temperature in the conveying pipe 5 is controlled, and the cooling medium comprises but is not limited to physiological saline, artificial cerebrospinal fluid and the like; the proximal end of the anchor and the delivery proximal end opening form an instrument delivery lumen 21 for delivering an instrument.
Or, one end of the medium conveying pipe extends from the outer side of the conveying pipe to the conveying distal end through the fixing piece, the other end extends out of the cavity of the conveying pipe to form a medium conveying cavity 20 for conveying a medium, and the cooling medium can be cooled on the inner side of the conveying pipe through the medium conveying pipe so as to control the temperature in the conveying pipe, wherein the cooling medium comprises but is not limited to physiological saline, artificial cerebrospinal fluid and the like; the proximal end of the anchor and the delivery proximal end opening form an instrument delivery lumen 21 for delivering an instrument.
Further, the media delivery tube 9 includes, but is not limited to, a luer assembly, a three-way assembly, etc. that provides a media delivery inlet 10.
Further, the cooling medium is conveyed into the medium conveying pipe 9 by a medium conveying device, wherein the medium conveying device comprises, but is not limited to, a syringe pump, a constant pressure injection device and the like.
Further, the medium conveying device further comprises a temperature control member for controlling the temperature of the cooling medium. The temperature control means includes, but is not limited to, insulation, refrigeration, and other temperature control devices.
Further, the low temperature in the low temperature environment in which the shunt is provided means that the deformation temperature of the shunt distal portion 3 is lower, such As lower than the Af temperature or lower than the As temperature; further, the delivery member also includes a shunt push rod 8 for moving the shunt distally and toward the brain pool; further, a protective sleeve is arranged outside the puncture member 4 and is configured to prevent damage to vascular tissues during the conveying process; further, the delivery system also includes a stop member configured to limit the penetration distance of the penetration member and/or the deployment depth of the shunt.
Further, the shunt system is provided with a non-ray-throwing mark; specifically, the shunt nitinol distal portion 3 and similar shape memory alloy distal portions 3, including an expanded configuration preformed into a deployed state above Af temperature (e.g., the configuration of fig. 1 when deployed), and a physiologically responsive configuration stretched or contracted into a delivery state below Ms temperature (e.g., the shape configuration of delivery); the distal end of the shunt is made of nickel-titanium alloy with Af=20 ℃ and As=10 ℃. During conveying, the diverter is conveyed in a conveying cavity of the conveying conduit 5 in a physiological saline environment at the temperature of 10 ℃, and a medium conveying device (such as a syringe, not shown) continuously or intermittently conveys physiological saline through a three-way pipe medium conveying inlet 10 and pushes the diverter through a diverter push rod 8; the puncture member 4 is positioned at the distal end of the delivery catheter 5, the elongated guide member 2 is positioned in the other delivery lumen of the delivery catheter 5, the distal end of the elongated guide member 2 is provided with a distal anchoring stent (i.e., an anchoring member), and a protective sleeve (not shown) is arranged outside the puncture member 4; the distal end of the shunt maintains the delivery configuration in a 10℃ saline environment, and when deployed to the cerebrospinal fluid (e.g., 37℃), expands, effecting an expanded deployment, resulting in a deployed configuration.
In summary, the present invention is not limited to the preferred embodiments, but is intended to cover modifications and equivalent arrangements included within the scope of the appended claims and their equivalents.
Claims (24)
1. A shunt for treating hydrocephalus configured for intravascular delivery and deployment in a venous system and a ventricular system of a patient, characterized by: the shunt includes:
a distal portion comprising a physiologically responsive member configured for introduction via the venous system and placement within a brain cell of a patient, the physiologically responsive member of the distal portion being expandable or settable under conditions of a cerebrospinal fluid physiological environment to effect fixation of the distal portion within the brain cell, upon or after deployment of the distal portion within the brain cell of a patient, and at least one fluid-pervious inlet; and a proximal portion configured for placement in a patient's venous system, the proximal portion having an outlet for fluid outflow; and a flexible body portion having a lumen extending therethrough to the proximal portion, wherein the lumen is in fluid communication with one or more inlets in the distal portion and with an outlet in the proximal portion such that when the shunt is deployed in the venous system and the distal portion of the shunt is disposed within the brain pool and the proximal portion of the shunt is disposed in the venous system, cerebrospinal fluid flows from the brain pool into the venous system through the one or more inlets, the lumen of the shunt, and the outlet, respectively.
2. The shunt according to claim 1, wherein: a controlled flow configuration is provided within the lumen of the flexible body portion or outside the inlet of the distal portion or outside the outlet of the proximal portion that only allows fluid to flow from the distal portion of the shunt into the proximal portion of the shunt.
3. The shunt according to claim 2, wherein: the control flow direction is configured as a one-way valve, a one-way flow surface, a one-way flow channel.
4. The shunt according to claim 1, wherein: the physiologically responsive member is a non-mechanical environmentally responsive distending member that swells or solidifies or sets in response to conditions of the physiological environment of cerebrospinal fluid.
5. The shunt according to claim 4, wherein: the physiological environment is conditioned by one or more of cerebrospinal fluid specific ingredients, temperature, pH or ion concentration.
6. The shunt according to claim 5, wherein: the physiological environment conditions are aqueous solution, the temperature is 35-43 ℃, and the pH value is as follows: 7.0-7.4, glucose concentration: 2.8-5.0mmol/L, chloride concentration: 110-132mmol/L or a mixture.
7. The shunt according to claim 4, wherein: the physiologically responsive member comprises a super absorbent resin, a water absorbent silica gel, a hydrogel, a water absorbent rubber, a shape memory alloy, or a combination thereof.
8. The shunt according to claim 7, wherein: the hydrogel includes a water-absorbing responsive hydrogel, a temperature-sensitive hydrogel, a specific ion/component responsive hydrogel, a body fluid responsive crosslinked hydrogel, or a combination thereof.
9. The shunt according to claim 7, wherein: the shape memory alloy phase transition temperature of the physiologically responsive member is less than or equal to the physiological environment temperature of the cerebrospinal fluid being deployed.
10. The shunt according to claim 1, wherein: a wrapping member for partially or completely wrapping the physiological response member is fixed on the distal portion tube wall.
11. The shunt according to claim 10, wherein: the wrapping member is a porous membrane structure having a pore size not greater than the particle size of the physiologically responsive member.
12. The shunt according to any one of claims 1-11, wherein: the outer side of the physiological response member is provided with a deformation member for limiting the expansion range of the physiological response member.
13. The shunt according to claim 1, wherein: the outside of the physiological response component is provided with a shielding protection structure for short-term isolation of blood or physiological response environmental conditions for the physiological response component.
14. The shunt according to claim 1, wherein: a shielding and protecting device is arranged at the proximal end part of the shunt and is used for isolating endothelial cells of a venous system from an outlet of the proximal end part of the shunt;
and/or a semipermeable membrane is arranged in the cavity of the shunt flexible body part or outside the inlet of the distal end part or outside the outlet of the proximal end part, and is used for limiting the flow, diffusion and exchange of partial components in the brain cell and the venous system;
and/or an inner polymer liner or anticoagulant layer is provided within the lumen of the shunt flexible body portion, the inner polymer liner or anticoagulant layer extending at least halfway between the distal end portion and the proximal end portion;
and/or the shunt outer surface is at least partially provided with an inner polymer liner or anticoagulant layer.
15. An environmental response shunt system for treating hydrocephalus, the system comprising:
the shunt according to any one of claims 1-14, and a delivery system;
The conveying system includes: a piercing member, a guide member, and a delivery member, wherein,
the delivery member comprises a delivery catheter having a lumen for receiving and delivering the shunt to the brain pool, a delivery distal end and a delivery proximal end at the distal end and the proximal end of the delivery catheter for delivery;
the guide member is arranged in the conveying guide pipe in a penetrating way and is used for guiding the conveying member to move;
the puncture member is positioned in the cavity of the delivery catheter or is connected with the distal end of the delivery catheter, and the distal end of the puncture member is provided with a puncture tip for forming an anastomotic passage between the venous system and the ventricular system through the puncture tip.
16. The shunt system according to claim 15, wherein: the guide member comprises an elongated guide member penetrating within the delivery catheter and an anchoring member for anchoring outside the delivery catheter, the distal end of the elongated guide member being connected to the anchoring member;
the shunt is placed within the piercing member cavity or the piercing member is placed within the shunt; or the puncture member is positioned outside the outer side surface of the shunt portion, and the shunt is positioned in the delivery member cavity.
17. The shunt system according to claim 15, wherein: the delivery system further includes a diverter push rod positioned within the delivery catheter lumen for clamping, pushing, pulling or limiting the diverter.
18. The shunt system according to claim 15, wherein: the guide member comprises one or a combination of a guidewire, a distal shapeable microcatheter, a guide catheter, a catheter with a single-sided balloon, a stent or balloon with a lumen, a contrast catheter, a stent with a guidewire, and the like.
19. The shunt system according to claim 15, wherein: one or more radiopaque markers are provided on the shunt system.
20. The shunt system according to claim 15, wherein: an operating handle is connected to a part or all of the proximal ends of the components of the conveying system.
21. The shunt system according to claim 15, wherein: the delivery system is provided with a shielded protective delivery configuration for short-term isolation of blood or physiological responsive environmental conditions for the shunt.
22. The shunt system according to claim 21, wherein: the shielding protection conveying structure is a temperature control component, and the temperature control component is arranged outside or inside the conveying conduit and used for controlling the temperature in the conveying conduit.
23. The environmental response diversion system of claim 22, wherein: the temperature control component comprises a fixing piece and a medium conveying pipe;
one end of the medium conveying pipe is arranged in the conveying pipe cavity through the fixing piece or one end of the medium conveying pipe extends from the outer side of the conveying pipe to the conveying distal end through the fixing piece, the other end extends out of the conveying pipe cavity to form a medium conveying cavity for conveying a medium,
the fixing piece is positioned at the conveying proximal end, and the proximal end of the fixing piece and the opening of the conveying proximal end form an instrument conveying cavity for conveying an instrument.
24. The environmental response diversion system of claim 22, wherein: and a temperature sensor is arranged in the temperature control component and is used for detecting the temperature of the conveying system.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN202311579344.8A CN117282006A (en) | 2023-11-24 | 2023-11-24 | Shunt and system for treating hydrocephalus |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202311579344.8A CN117282006A (en) | 2023-11-24 | 2023-11-24 | Shunt and system for treating hydrocephalus |
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| CN202311579344.8A Pending CN117282006A (en) | 2023-11-24 | 2023-11-24 | Shunt and system for treating hydrocephalus |
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