CN117282005A - Shunt for treating hydrocephalus and system thereof - Google Patents
Shunt for treating hydrocephalus and system thereof Download PDFInfo
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- CN117282005A CN117282005A CN202311579343.3A CN202311579343A CN117282005A CN 117282005 A CN117282005 A CN 117282005A CN 202311579343 A CN202311579343 A CN 202311579343A CN 117282005 A CN117282005 A CN 117282005A
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- shunt
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- puncture
- treating hydrocephalus
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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
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- 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
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- 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
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- 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
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- A—HUMAN NECESSITIES
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- A61M25/00—Catheters; Hollow probes
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- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
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- A—HUMAN NECESSITIES
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- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
- A61M2025/0253—Holding devices, e.g. on the body where the catheter is attached by straps, bands or the like secured by adhesives
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Anesthesiology (AREA)
- Veterinary Medicine (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Vascular Medicine (AREA)
- Surgery (AREA)
- Otolaryngology (AREA)
- Ophthalmology & Optometry (AREA)
- Neurology (AREA)
- Child & Adolescent Psychology (AREA)
- Prostheses (AREA)
Abstract
The invention discloses a shunt for treating hydrocephalus and a system thereof, wherein the shunt comprises a distal end part, a proximal end part and a tube body, the distal end part is provided with a fixing component, and when or after the distal end part is deployed in a ventricle system of a patient, the fixing component is contacted and matched with a puncture to increase the contact force, friction force and adhesion force between the distal end part and the puncture, so that the distal end part is deployed in the ventricle system of the patient through fixation and/or limit. According to the shunt system, the contact force, the friction force and/or the adhesive force between the tube body and the meninges puncture opening are increased in a short period through the fixing member, contact anchoring is formed, biological fixation is formed through the growth adhesion of meninges cells for a long period, so that the fixation of the shunt tube is realized, meanwhile, the adhesion and friction increase of the tube body and the meninges can ensure the sealing isolation of cerebrospinal fluid and a venous system, so that the compression to the dura mater is reduced, the sealing performance is enhanced, the recovery is convenient, and the operation difficulty and risk are reduced.
Description
Technical Field
The present invention relates to a shunt for accessing the brain pool and draining cerebrospinal fluid (CSF) using an intravascular approach and systems and methods thereof, and more particularly to a shunt for treating hydrocephalus and systems thereof.
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 clear 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. About 450 to 500mL of CSF is produced and reabsorbed daily, enabling about 8-16cm H to be produced in the intracranial ventricle 2 Steady state volume and pressure of O. 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 shunt of cerebral effusion through percutaneous/vascular intervention has been proposed, as shown in fig. 1, in which a shunt is deployed in the infront sinus (IPS) and the cerebellar pontic brain (CP) angle cistern of a 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.
For example, the shunt of the technical solutions of patent CN108136164B and CN107148293B achieve fixation by automatic inflation deployment, which fixation is established by a constant compression provided to the dura mater near the puncture, thereby possibly causing a series of complications. When the shunt tube needs to be disassembled, reassembled or recovered, the dura mater of the puncture point can be continuously expanded due to the fact that the self-expanding distal end of the shunt tube has larger fixing force and larger outer diameter, the dura mater of the puncture point is easy to tear, and operation difficulty and risk are increased. In addition, in the technical scheme, the puncture opening of the dura mater is formed by a large-diameter needle, the sealing capability between the dura mater with a large aperture and the tube body with a small diameter is weak, and accidental communication between a brain pool and a venous system is easy to form.
In order to solve the problems, the invention provides a shunt for treating hydrocephalus and a system thereof, which can reduce the compression to the dura mater, enhance sealing and facilitate recovery.
Disclosure of Invention
The invention aims to provide a shunt for treating hydrocephalus and a system thereof, wherein the shunt increases the contact force, friction force and/or adhesion force between the shunt and the dura mater of a cerebral ventricular system and/or the anastomotic opening/puncturing opening of the arachnoid membrane in a short term through a fixing component to form contact anchoring, and forms biological fixation through the growth and adhesion of meningeal cells in a long term, so as to realize the fixation of a distal end part of the shunt in the cerebral ventricular system; meanwhile, the adhesion and friction increase of the shunt tube body and the dura mater and/or the arachnoid can ensure the sealing isolation of the cerebral spinal fluid and the venous system, so that the compression to the dura mater is reduced, the sealing performance is enhanced, the recovery is convenient, and the operation difficulty and risk are reduced.
In order to achieve the technical purpose, the invention adopts the following technical scheme: in one aspect, the invention proposes a shunt for treating hydrocephalus, comprising a distal portion provided with a cerebrospinal fluid inlet and for deployment in a ventricular system of a patient, a proximal portion provided with a cerebrospinal fluid outlet and for deployment in a venous system of a patient, and a tube communicating the distal portion and the proximal portion for draining cerebrospinal fluid from the ventricular system to the venous system, the distal portion being provided with a fixation member which, upon or after deployment of the distal portion in the ventricular system of a patient, cooperates in contact with a puncture of the dura mater and/or arachnoid membrane to increase contact force and/or friction force and/or adhesion between the distal portion and the puncture such that the distal portion is fixed and/or restrained deployed in the ventricular system of a patient by the fixation member.
In particular, the delivery system may be accessed from a point proximal to the venous system, such as a femoral vein access, a radial vein access.
Further, the fixing member adopts an adhesive, a friction increasing structure and/or a pressurizing structure; the adhesive is configured to improve adhesion between the shunt and the puncture such that the distal portion is secured and/or limitedly deployed in the ventricular system of the patient by the adhesion provided by the securing member; the friction enhancing structure is configured to enhance friction between the shunt and the puncture such that the distal portion is secured and/or limitedly deployed in the ventricular system of the patient by friction provided by the securing member; the pressurization structure is configured to increase contact pressure between the shunt and the puncture such that the distal portion is secured and/or limited for deployment in the ventricular system of the patient by the contact pressure provided by the securing member.
In some embodiments, the adhesive is preferably a hydrogel or a medical gel, and the hydrogel is further preferably a degradable hydrogel.
Further, the adhesive is deployed at the distal portion by means of a pre-positioning or intra-operative filling; in some embodiments, the intra-operative filling is by: a filling port is arranged at the pre-deployment position of the fixing member, and the adhesive is filled to the pre-deployment position through the filling port by a filling pipe to form the fixing member.
In some embodiments, the friction enhancing structure employs one of a microstructure that increases the coefficient of friction, a porous structure, a threaded structure, a hydrophilic microstructure, a multi-ring structure, a twill structure, or a combination thereof.
Further, the pressurization structure is an expandable structure. In some embodiments, the expandable structure employs one of a self-expanding stent, a water-absorbing expandable structure, a self-expanding balloon, or a combination thereof.
Further, the expandable structure is provided with an isolation member for isolating the ventricular system from the venous system. In some embodiments, the spacer member is one of a film, a woven dense mesh, a tightly wound mesh, a pouch, a hydrophobic porous membrane, or a combination thereof.
Further, the shape of the fixing member is a non-smooth circle.
Further, the fixation member includes a pro-cell adhesion/proliferation, anti-inflammatory structure or component for promoting engagement of the stoma/puncture with the fixation member or controlling inflammation of the stoma/puncture upon or after deployment of the distal portion in the ventricular system of the patient.
Further, the shunt further includes a stop disposed between the proximal portion and the ventricular system, the stop configured to have a radial dimension greater than a radial dimension of the stoma/puncture to limit access of the proximal portion into the ventricular system; and/or, in some embodiments, the shunt further comprises a shielding guard disposed at a proximal portion thereof, the shielding guard configured to isolate endothelial cells of the venous system from the outlet of the proximal portion for outputting cerebrospinal fluid.
Further, the shunt is provided with an anticoagulant layer on part or all of the surface and/or a polymer liner capable of inhibiting adhesion of the shunt surface to proteins and/or cells; and/or, in some embodiments, the shunt includes at least one radiopaque marker positioned at the distal portion, or the tube, or the proximal portion, or the fixation member, or a combination thereof.
Further, the tube body forms a shunt cavity which communicates an inlet of the distal end portion and an outlet of the proximal end portion, and a flow control member which only allows cerebrospinal fluid to flow from the inlet of the distal end portion into the outlet of the proximal end portion is arranged in the shunt cavity; and/or the shunt is provided with a control flow member, the control flow member being provided at the distal portion and/or the proximal portion; and/or the shunt is provided with a semi-permeable membrane for restricting the flow, diffusion or exchange of a portion of the components in the ventricular and venous systems.
Further, the flow direction control member is configured as one of a one-way valve, a one-way flow surface, a one-way flow channel, or a combination thereof, that restricts flow direction.
In another aspect, the present invention provides a shunt system for treating hydrocephalus comprising a delivery system and the shunt; the delivery system is configured to introduce the shunt into the patient through the venous system and to guide the shunt into the venous system and the ventricular system of the patient.
In some embodiments, the delivery system includes a piercing member, a first delivery member, and a guide member; in some embodiments, the piercing member has a piercing tip through which the piercing member penetrates into a patient's body to form a piercing opening for the shunt to pass through its venous system and ventricular system; the first delivery member is configured to deliver the piercing member and/or the shunt to a specified location in the venous system with the assistance of a guide member.
Further, the distal end of the first delivery member and/or the piercing member directs the piercing tip into contact with dural tissue.
In some embodiments, the body portion distal end of the piercing member is configured as a hypotube structure; and/or, in some embodiments, the puncture tip is provided as a bevel blade needle, or a quke tip needle, or a half-blade needle, or a lancet needle, or a nib needle, or a radio frequency probe; and/or, in some embodiments, the piercing tip and/or piercing member body are provided with a radiopaque marker.
In some embodiments, the guide member is in guiding connection with the first delivery member and/or the piercing member, the guide member guiding the first delivery member and/or the piercing member to move in a particular direction and position such that the shunt is delivered to a specified location in the venous system; the guide member is located within the first conveying member.
In some embodiments, the first delivery member is a delivery catheter; the delivery catheter has a first delivery lumen that directs movement of the penetrating member and shunt toward the ventricular system; and a second delivery lumen in guided connection with the guide member.
In some embodiments, the guide member is provided as one or a combination of a guidewire, or a distal shapeable microcatheter, or a guide catheter, or a contrast catheter, or a catheter with a single-sided balloon, or a stent or balloon with a lumen, or a stent with a guidewire.
Further, the guide member is distally provided with an anchoring member for securing the guide member in the venous system.
In some embodiments, the delivery system further comprises a second delivery member configured to grip or push or pull or stop the shunt, configured to deliver and/or deploy a distal portion of the shunt at a specified location in the venous system into the ventricular system.
In some embodiments, the piercing member is disposed at a distal end of the first delivery member, or a distal end of the second delivery member, or a distal end of the shunt, or a distal end of the guide member, or the piercing member is disposed as a piercing catheter.
Further, the second delivery member is a shunt push rod, and a proximal portion of the shunt push rod is coupled to the first delivery member and contacts the stop portion of the shunt to push the shunt and/or the piercing member toward the ventricular system.
Further, the delivery system includes at least one radiopaque marker positioned on one or a combination of the first delivery member, or the second delivery member, or the piercing member, or the guide member.
Further, the delivery system also includes a stop member configured to limit a penetration distance of the penetration member and/or a deployment depth of the shunt.
Further, the stop member is coupled to the first delivery member proximal end for snap-fit engagement with the body proximal end of the piercing member.
In some embodiments, some or all of the components of the delivery system employ an orientable curved configuration.
In some embodiments, the system includes an operating handle to which the proximal end of some or all of the components of the delivery system are connected, the operating handle being used to operate the delivery system, and/or the shunt.
After the scheme is adopted, the invention has the following beneficial effects:
1. in the shunt, the anchoring position of the distal end part of the shunt is the anastomotic stoma/puncture on the dura mater/arachnoid membrane, the anchoring principle is that the contact force, the friction force and/or the adhesive force between the shunt tube body and the dura mater and/or the anastomotic stoma/puncture of the arachnoid membrane are increased in a short term through the fixing member of the distal end part of the shunt, so as to form contact anchoring, and the cells are adhered to the fixed member by growing on the dura mater for a long term, so that biological fixation is formed (for example, the dura mater and/or the arachnoid mater cells can grow and heal under the action of the adhesive such as polyethylene glycol or the fixing member such as a rough surface, and the cells climb the outer edge of the shunt tube, so that the biological fixation can be realized), thus being different from the principle of the prior art.
2. The distal end part of the shunt does not have a limit structure which invades the ventricle system, so that side pressure is not applied to the ventricle system, the operation complications are reduced, the large-diameter expansion anchoring structure is not provided, the force required for recovery is obviously smaller, the damage to the dura mater during recovery is small, and the recovery operation difficulty and risk are obviously reduced.
Drawings
In order to more clearly illustrate the embodiments of the invention or the technical solutions of the prior art, the drawings which are used in the description of the embodiments or the prior art will be briefly described, it being obvious that the drawings in the description below are only some embodiments of the invention, and that other variants can be obtained according to these drawings without the aid of inventive efforts to a person skilled in the art.
FIG. 1 is a schematic diagram of a therapeutic approach for cerebral hydrocephalus shunt via percutaneous/vascular intervention;
FIG. 2 is a schematic diagram of a shunt deployment process of the present invention;
FIG. 3 is a state diagram of the completion of the deployment of the shunt of the present invention;
FIG. 4 is a block diagram of a diverter employing an adhesive attachment member in accordance with the present invention;
FIG. 5 is a schematic illustration of the filling of the present invention with an adhesive securing member;
FIG. 6 is a block diagram of a diverter employing a plenum structure securing member in accordance with the present invention;
FIG. 7 is a block diagram of a diverter coated with a membrane using a plenum structure fixation member in accordance with the present invention;
FIG. 8 is a block diagram of a non-smooth circular fixation member employed in accordance with the present invention;
fig. 9 is a schematic view of seven flow direction control members according to an embodiment of the present invention, in which fig. 9 (a) is a duckbill valve structure diagram according to the present invention, fig. 9 (b) is a double-diaphragm valve structure diagram according to the present invention, fig. 9 (c) is a double-valve structure diagram according to the present invention, fig. 9 (d) is a single-valve structure diagram according to the present invention, fig. 9 (e) is a tesla valve structure diagram according to the present invention, fig. 9 (f) is a one-way flow surface valve structure diagram according to the present invention, and fig. 9 (g) is a one-way flow surface structure diagram according to the present invention;
FIG. 10 is a block diagram of the cooperation of the piercing member and the shunt of the present invention;
FIG. 11 is another block diagram of the cooperation of the piercing member and shunt of the present invention;
FIG. 12 is a block diagram of a shunt system of the present invention;
FIG. 13 is a block diagram of the cooperation of the piercing member and the first delivery member of the present invention;
fig. 14 is a schematic view of three orientable bend configurations according to an embodiment of the present invention.
Description of the reference numerals
The shunt 1, distal portion 11, cerebrospinal fluid inlet 111, proximal portion 12, cerebrospinal fluid outlet 121, tube 13, fixation member 14, filling port 15, filling tube 16, spacer member 17, stopper 18, piercing member 2, piercing member body 21, piercing tip 22, stopper 23, necked down section 24, second stopper member 25, first delivery member 3, first delivery lumen 31, second delivery lumen 32, first stopper member 33, second delivery member 4, guide member 5, guidewire 51, anchoring member 52, one-way valve 10, one-way flow surface 20, one-way flow channel 30, balloon/stent 40, balloon/stent 50 with a hollow curved path.
Detailed Description
The technical solutions of the embodiments of the present invention will be clearly described below with reference to the drawings in the embodiments of the present invention, and it is apparent that the described embodiments are only some embodiments of the present invention, not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
The invention discloses a shunt for treating hydrocephalus and a system thereof, wherein the shunt system comprises a delivery system and a shunt 1.
The delivery system comprises a piercing member 2, a first delivery member 3, a second delivery member 4 and a guiding member 5, the delivery system being configured to introduce the shunt 1 into the patient via a venous system and to guide the shunt 1 into the venous system and ventricle system of the patient. The piercing member 2 penetrates the patient's body through its piercing tip 21 to form a piercing port for the shunt 1 to pass through its venous system and ventricular system.
The shunt 1 comprises a distal portion 11 provided with a cerebrospinal fluid inlet 111 for deployment in the ventricular system of a patient, a proximal portion 12 provided with a cerebrospinal fluid outlet 121 for deployment in the venous system of a patient, and a tube communicating the distal portion 11 and the proximal portion 12 for draining cerebrospinal fluid from the ventricular system to the venous system, the distal portion 11 being provided with a fixation member 14, the fixation member 14 being in contact engagement with the dura mater and/or the puncture of the arachnoid membrane during or after deployment of the distal portion 11 in the ventricular system of a patient to increase the contact force and/or friction and/or adhesion between the distal portion 11 and the puncture such that the distal portion 11 is fixed and/or limitedly deployed in the ventricular system of a patient by the fixation member 14. In particular, the delivery system may be accessed from a point proximal to the venous system, such as a femoral vein access, a radial vein access.
As shown in fig. 2 and 3, the present invention provides a shunt 1 comprising a distal portion 11 provided with a cerebrospinal fluid inlet 111, a proximal portion 12 provided with a cerebrospinal fluid outlet 121, the distal portion 11 being deployed in the ventricular system (which may be the small pontic angle reservoir) of a patient, the proximal portion 12 being for deployment in the venous system (which may be internal or near the jugular vein) of the patient, and a tube 13 having a shunt lumen 131, the shunt lumen 131 communicating the cerebrospinal fluid inlet 111 with the cerebrospinal fluid outlet 112, the tube 13 extending from the distal portion 11 to the proximal portion 12. The distal portion 11 is provided with a fixation member 14, which fixation member 14 cooperates in contact with the dura mater and/or the puncture of the arachnoid membrane to increase the contact force and/or friction and/or adhesion between the distal portion 11 and the puncture, when or after the distal portion 11 is deployed in the ventricular system of the patient, such that the distal portion 11 is fixed and/or limitedly deployed in the ventricular system of the patient by the fixation member 14. When the distal portion of the shunt is disposed within the ventricular system and the proximal portion is disposed in the venous system, cerebrospinal fluid flows from the ventricular system into the venous system sequentially through the cerebrospinal fluid inlet 111, the shunt lumen 131, and the cerebrospinal fluid outlet 121. Further, the cerebrospinal fluid inlet 111 and the cerebrospinal fluid outlet 121 may each be provided in one to a plurality. As such, the shunt lumen 131 of the tube 13 is in communication with one or more of the cerebrospinal fluid inlets 111 of the distal portion 11 and with one or more of the cerebrospinal fluid outlets 121 of the proximal portion 12. When the shunt 1 is deployed in a venous system and the distal portion 11 of the shunt 1 is disposed within the ventricular system and the proximal portion 12 of the shunt 1 is disposed in or near the venous system, particularly the jugular vein, cerebrospinal fluid flows from the ventricular system, particularly the small pontic brain angle pool, into the jugular vein through one or more cerebrospinal fluid inlet openings, the shunt lumen of the shunt 1, and the cerebrospinal fluid outlet 121 opening, respectively.
In some embodiments, the fixation member 14 may employ a composition including, but not limited to, an adhesive, a friction enhancing structure, or a pressurizing structure; wherein, as shown in fig. 4, the fixation member 14 in the embodiment is configured as an adhesive that increases adhesion, the adhesive being in contact with the puncture, improving adhesion between the shunt 1 and the puncture such that the distal portion 11 is fixed and/or limitedly deployed in the ventricular system of the patient by the adhesion provided by the fixation member 14; in some embodiments, the adhesive is preferably a hydrogel or a medical gel, and the hydrogel is further preferably a degradable hydrogel. In some embodiments, the hydrogel or medical gel may include, but is not limited to, natural component sealants (e.g., fibrin-based gels), semisynthetic gels (e.g., gelatin and albumin-based gels), fully synthetic gels (acrylates and polyethylene glycol-based gels), and the like, and combinations thereof, such as meningeal cells that can grow and heal under the action of an attachment agent such as polyethylene glycol-based gel or a fixation member such as a roughened surface, and cells that climb the wall at the outer edge of the shunt tube, allowing bioscaling. The polyethylene glycol gums include, but are not limited to, four-arm polyethylene glycols (e.g., four-arm polyethylene glycol succinimidyl glutarate) and derivatives thereof, eight-arm polyethylene glycols and derivatives thereof, and the like, and combinations thereof. Further, the four-arm polyethylene glycol hydrogel is prepared by mixing four-arm polyethylene glycol-N-hydroxysuccinimide-glutarate (4-arm-PEG-SG), brilliant blue 85 serving as a coloring agent, dibutyl hydroxytoluene (BHT) serving as an antioxidant, an acidic phosphate buffer solution and an alkaline sodium tetraborate buffer solution containing Tri-lysine (Tri-lys) and Polyethyleneimine (PEI).
As shown in fig. 5, in some embodiments, the adhesive is deployed at the distal portion 11 by way of a pre-positioned or intra-operative filling; specifically, the filling mode in the operation is as follows: a filling port 15 is provided in the pre-deployment position of the fixation member 14, and the adhesive is filled through the filling port 15 to the pre-deployment position through a filling tube 16 to form the fixation member 14.
Specifically, the orifice of the filling tube 16 may be connected to the cerebrospinal fluid outlet 121 of the proximal portion 12 of the shunt, and movably connected via the shunt lumen 131 near the fixable member 13 or sleeved on the inner wall of the tube body 13.
In some embodiments, the fixation member 14 is configured as a friction enhancing structure that increases friction, the adhesive is in contact with the puncture, increasing friction between the shunt 1 and the puncture such that the distal portion 11 is fixed and/or limitedly deployed in the ventricular system of the patient by the friction provided by the fixation member 14; in some embodiments, the friction enhancing structures may employ, but are not limited to, friction coefficient increasing microstructures, porous structures, threaded structures, hydrophilic microstructures, multi-ring structures, water swellable materials (increasing positive pressure), twill structures, further, the friction coefficient increasing microstructures include, but are not limited to, ra (surface roughness) greater than 1.6 μm surfaces, textured surfaces, sand blasted surfaces, and other microstructures that increase the friction coefficient between a biofilm and a tubular body material.
As shown in fig. 6 and 7, the pressurization structure is configured to increase the contact pressure between the shunt and the puncture such that the distal portion 11 is secured and/or restrained for deployment in the ventricular system of the patient by the contact pressure provided by the securing member 14.
Further, the pressurizing structure is an expandable structure including, but not limited to, a stent graft, a water-absorbent resin. In some embodiments, the expandable structure employs a self-expanding stent, a water-absorbing expandable structure, or a self-expanding balloon, and both fig. 6 and 7 are securing members 14 employing a self-expanding stent.
Further, the expandable structure is provided with an isolation member for isolating the ventricular system from the venous system. In some embodiments, the isolation member 17 may be, but is not limited to, a membrane, a woven mesh, a tightly wound mesh, a balloon, a hydrophobic porous membrane, as shown in fig. 6, and may be wrapped around the fixation member 14 to achieve a seal between the ventricular system and the venous system.
As shown in fig. 8, the shape of the fixing member 14 may be, but not limited to, a non-smooth circular shape, and the non-smooth circular shape of the fixing member 14 may increase the contact area with the anastomotic stoma/puncture, and increase friction force, so that the distal portion of the shunt 1 is more easily fixed or limited to the anastomotic stoma/puncture of the ventricular system.
Further, the fixation member 14 includes a pro-cell adhesion/proliferation, anti-inflammatory structure or component for promoting the engagement of the stoma/puncture with the fixation member 14 or controlling inflammation of the stoma/puncture when or after the distal portion 11 is deployed in the ventricular system of a patient.
Further, the shunt 1 further includes a stop 18, as shown in fig. 6 and 7, the stop 18 may be, but is not limited to, a stop collar structure, the stop 18 being disposed between the proximal portion 12 and the ventricular system, the stop 18 being configured to have a radial dimension greater than a radial dimension of the stoma/puncture to limit the entry of the proximal portion 12 into the ventricular system; in some embodiments, the shunt 1 further comprises a shielding protection (not shown in the figures) disposed at its proximal portion 12, said shielding protection being configured for isolating endothelial cells of the venous system from the outlet of the proximal portion 12 for outputting cerebrospinal fluid. The shielding protection part is arranged to include, but not limited to, a bracket, a balloon and a film.
In some embodiments, a portion or all of the surface of the shunt 1 is provided with an anticoagulant layer and/or a polymer liner capable of inhibiting adhesion of the shunt surface to proteins and/or cells, the portion or all of the surface of the shunt 1 including the exterior surface of the shunt 1 and the portion or all of the luminal surface; and/or, in some embodiments, the shunt 1 includes at least one radiopaque marker positioned at the distal portion 11, or the tube 13, or the proximal portion 12, or the fixation member 14, or a combination thereof.
In some embodiments, a radiopaque marker (denoted as a first marker band) is provided at the distal end of distal portion 11 for locating the position of tube 13 in the brain cell, avoiding tube 13 touching brain tissue while pushing, while locating the stability of distal portion 11, without substantial movement out of the brain cell in the brain cell; a radiopaque marker (denoted as a second marker band) is arranged at the bottom of the distal end part for positioning the relative position of the distal end part 11 of the shunt and the delivery system, and can be used for positioning whether the distal end part 11 of the shunt is completely actuated and deformed in the brain pool during puncture; a radiopaque marker (denoted as a third marker band) is provided at the interface of the tube 13 with a flow control member (such as a duckbill valve) for locating the stability of the flow control member described below and for confirming the stability of the shunt 1.
In some embodiments, the shunt is provided with a control flow member (such as a duckbill valve) disposed at the distal portion 11 and/or the proximal portion 12; in some embodiments, the shunt 1 has a semipermeable membrane disposed therein for restricting the flow, diffusion or exchange of a portion of the components in the ventricular and venous systems, which may be, but is not limited to, a PTFE porous membrane or an ePTFE porous membrane. The semipermeable membrane can be arranged at any position of the shunt according to the requirement, and can be arranged in one or more than one.
Further, the tube body 13 forms a shunt chamber 131, the shunt chamber 131 communicating an inlet of the distal portion 11 (cerebrospinal fluid inlet 111) and an outlet of the proximal portion 12 (cerebrospinal fluid outlet 121), a flow direction control member being provided in the shunt chamber 131 to allow only cerebrospinal fluid to flow from the inlet of the distal portion into the outlet of the proximal portion;
in some embodiments, the flow direction control means adopts, but is not limited to, a one-way valve 10, a one-way flow surface 20 and a one-way flow channel 30 for limiting the flow direction, as shown in fig. 9 (a) -9 (g), the one-way valve can adopt, but is not limited to, a duckbill valve 101, a membrane valve 102, a double-flap valve 103 and a single-flap valve 104, and as shown in fig. 9 (a) - (d), the structural diagrams of the duckbill valve 101, the slit valve, the membrane valve 102, the double-flap valve 103 and the single-flap valve 104 can all realize better one-way flow direction control. A one-way flow path as shown in fig. 9 (e) may employ a tesla valve. The unidirectional flow surface can be selected from unidirectional flow microstructure, hydrophilic-hydrophobic alternate structure or unidirectional damping surface structure, as shown in fig. 9 (f) and fig. 9 (g) and unidirectional flow microstructure (submillimeter three-dimensional capillary saw tooth structure), and can realize better unidirectional flow direction control effect.
The invention also provides a shunt system for treating hydrocephalus, the shunt system comprising a delivery system and the shunt 1; the delivery system is configured to introduce the shunt into the patient through the venous system and to guide the shunt 1 into the venous system and the ventricular system of the patient.
In some embodiments, the delivery system comprises a piercing member 2, a first delivery member 3, and a guide member 5; further, the puncture member 2 has a puncture tip, and the puncture member 2 penetrates into the patient through the puncture tip to form a puncture opening for the shunt to pass through by the venous system and the ventricular system; the first delivery member 3 is configured to deliver the piercing member 2 and/or the shunt to a specified location in the venous system with the aid of guiding by guiding member 5.
In particular, the distal end of the first delivery member 3 and/or the piercing member 2 directs the piercing tip into contact with dural tissue, the distal end being configured in a manner that includes, but is not limited to, deflection by distal end pre-shaping, with a unilateral balloon, a stent or balloon on the outside of the vessel wall, and the like.
In some embodiments, the guiding member 5 is in guiding connection with the first delivery member 3 and/or the piercing member 2, the guiding member 5 guiding the first delivery member 3 and/or the piercing member 2 to move in a specific direction and position such that the shunt is delivered to a specific location in the venous system; the guide member 5 is located within the first conveying member 3.
In particular, as shown in fig. 1, 2 and 11, the first delivery member 3 has a first delivery lumen 31 that directs movement of the piercing member 2 and shunt in the direction of the ventricular system; a second delivery chamber in guiding connection with said guiding means 5. The piercing member 2 is located within the first delivery lumen 31 and the shunt 1 is located within the piercing member 2.
In some embodiments, the first delivery member 3 is a delivery catheter.
In some embodiments, the piercing member 2 is provided as a piercing catheter.
In some embodiments, the distal end of the body portion of the piercing member 2 is configured as a hypotube; in some embodiments, the piercing tip 22 is configured as a bevel blade needle, or a quck tip needle, or a half-tipped needle, or a lancet needle, or a nib needle, or a radio frequency probe; in some embodiments, the penetrating member 2 distal to the shunt 1 is preferably a degradable material.
In some embodiments, the piercing tip 22 is provided with a radiopaque marker, or the piercing member 2 body is provided with a radiopaque marker. Radiopaque markers include, but are not limited to, components having a radiopaque material composition, components coated with a radiopaque coating, and additional radiopaque components.
In some embodiments, the guide member 5 is provided as, but is not limited to, a guidewire, a distal shapeable microcatheter, a guide catheter, a contrast catheter, a catheter with a single-sided balloon, a stent or balloon with a lumen, a stent with a guidewire. The guide member may also be provided as other suitable member.
Further, the distal end of the guide member 2 has a radiopaque marker for locating the position of the guidewire of the guide member 2 in the inferior rock sinus.
In some embodiments, the guide member 5 is distally provided with an expandable and/or retrievable anchoring member 52, the anchoring member 52 being used to secure the guide member 5 in the venous system. The anchoring member includes, but is not limited to, a stent, a balloon. Further, an anchor member may be disposed at the distal end of the guide member. As shown in fig. 1, in some embodiments, the guide member is provided as a guidewire and the anchor member is provided as a stent or balloon for guiding and anchoring the delivery system.
Further, in some embodiments, the delivery system further comprises a second delivery member 4, the second delivery member 4 configured to grip or push or pull or stop the shunt, configured to deliver and/or deploy a distal portion of the shunt at a specified location in the venous system into the ventricular system.
Specifically, the second conveying member 4 is located within the first conveying chamber 51 of the first conveying member 5.
In some embodiments, the penetrating member 2 may be disposed at the distal end of the first delivery member, the distal end of the second delivery member, the distal end of the shunt, the distal end of the guide member, the distal end of the dilating member.
Further, the second delivery member 4 is configured as a shunt pusher between the first delivery member 3 or the piercing member 2 and the shunt 1, and a proximal portion of the shunt pusher is received in the first delivery lumen 31 of the first delivery member and contacts the stop portion of the shunt to urge the shunt and/or the piercing member 2 to move in the direction of the ventricular system.
Further, the delivery system comprises at least one radiopaque marker, the position of which can be provided in the first delivery member 3, the second delivery member 4, the piercing member 2, the guiding member 5. Radiopaque markers include, but are not limited to, components having a radiopaque material composition, components coated with a radiopaque coating, and additional radiopaque components. The radiopaque markers may be provided in 1, 2 to more.
In particular, radiopaque markers are provided between the bottom of the distal shunt portion 11 and the second delivery member 4 for locating the relative position of the distal shunt portion 11 and the second delivery member 4, which can be used to locate the presence or absence of complete actuation deformation of the distal shunt portion 11 in the brain pool during penetration. In particular, the radiopaque markers may be provided on both the shunt 1 and the second delivery member 4.
In some embodiments, the second delivery member 4 is disposed on the penetrating member 2, i.e., the shunt 1 is pushed and deployed by the second delivery member 4 on the penetrating member 2. In other embodiments, the second delivery member 4 may also be provided with a delivery catheter, a delivery push tube, etc. as desired.
Specifically, as shown in fig. 10 and 11, the penetrating member body 21 is configured as a penetrating catheter, and during delivery, the shunt 1 is positioned within the penetrating catheter lumen, and in some embodiments, a stop 23 is disposed within the penetrating catheter distal tube as the second delivery member 4, the stop 23 forming a stop with the proximal end of the fixation member 14, such that the stop pushes and deploys the shunt 1; in other embodiments, the inner wall of the distal end of the puncture catheter is provided with a necked-down section 24 as the second delivery member 4, the necked-down section 24 forming a stop with the proximal end of the fixation member 14 to push and deploy the shunt.
Further, the delivery system further comprises a stop member configured to limit the penetration distance of the penetration member 2 and/or the deployment depth of the shunt 1. In particular, the stop member is coupled to the proximal end of the first delivery member 3 for snap-fit engagement with the proximal end of the body of the piercing member 2 to limit the distance that the piercing tip 22 can be advanced distally into the brain cell.
Specifically, the proximal end of the first delivery member 3 is provided with a first stop member 33 and the proximal end of the piercing member 2 is provided with a second stop member 25 for cooperating with the first stop member 33 to form a detent structure. The first stop member 33 and the second stop member 25 form a detent to limit the distance that the piercing tip 22 at the distal end of the tissue piercing member 2 can advance distally into the brain pool, as shown in fig. 13, the first stop member 33 being a stop or a developing ring at the proximal end of the piercing catheter, and the second stop member 25 being a stop wall formed within the delivery catheter, the stop or developing ring forming a detent with the stop wall.
In particular, in some embodiments, the shunt system further comprises an operating handle to which the proximal end of some or all of the components of the delivery system are connected, the operating handle being used to operate the delivery system, and/or the shunt.
As shown in fig. 14, in some embodiments, some or all of the components of the delivery system employ an orientable bending structure that may employ a distal pre-plastic bending structure (fig. 14 (a)), a stented or balloon-fixed bending structure (fig. 14 (b)), a pre-formed path bending structure (fig. 14 (c)), wherein the bending portion involves the first delivery component 3 (delivery catheter) and/or the piercing component 2 (piercing catheter), wherein the stented or balloon-fixed bending structure is implemented by means of the balloon/stent 40, and the pre-formed path bending structure is implemented by deforming the balloon/stent 50 with a hollow bending path that ensures a correct direction of movement upon piercing, reducing the risk of surgery.
The first embodiment, the second embodiment and the third embodiment are combined to describe the shunt and the system for treating hydrocephalus.
Example 1
As shown in fig. 1 and 2, the shunt system according to the first embodiment of the present invention includes a shunt and a delivery system including a puncture member 2, a first delivery member 3, a second delivery member 4, and a guide member 5; the distal portion 11 of the shunt 1 is provided with an adhesive as a fixation means 14, in particular medical glue, and a duckbill valve as a flow control means (not shown) at the proximal end for controlling the unidirectional flow of cerebrospinal fluid from the brain pool into the venous system. The shunt 1 is located within a piercing member body 21 (employing a piercing catheter) and a second delivery member 4 (employing a shunt pusher) that is provided with a piercing tip 22 at a distal end thereof, the shunt pusher being operable to urge the shunt body 13 to move and deploy. The first conveying member 3 (conveying catheter) is a double-cavity conveying catheter, wherein the first conveying cavity 31 accommodates a puncture catheter, the second conveying cavity 32 accommodates a guide wire 51 of the guide member 5, the guide wire 51 adopts a flat guide wire, and the far end of the second conveying cavity 32 of the first conveying member 3 (conveying catheter) is arranged at a certain distance from the first conveying cavity 31, and in particular, the distance is 3-20mm; the guide member 5 further comprises an anchoring member 52 located under the rock Dou Yuanduan.
The working process of the conveying system comprises the following steps: femoral vein puncture, construction of an interventional pathway, guiding microcatheter delivery to the left internal jugular vein, after which the delivery system may be advanced into the inferior petrous sinus in four ways.
In mode (1), under the double-C-arm positive lateral venous phase roadmap, the flat guide wire guides the microcatheter into the inferior rock sinus.
In the mode (2), the black loach guide wire guides the single-bend radiography guide tube to butt joint the rock sinus, the black loach guide wire is withdrawn, and under the indication of the common carotid artery normal position roadmap, the flat guide wire guides the microcatheter to be over-selected to the rock sinus through the radiography guide tube, and the microcatheter enters about 30mm from the outlet of the internal jugular vein guide tube. The flattened guidewire is withdrawn and the expandable anchoring structure of the delivery system, the anchoring stent, is advanced with the microcatheter to a depth of about 30mm.
Mode (3), in the case of a narrow under-rock Dou Rukou: the exchange loach guide wire is sent into a guide catheter, the guide catheter is removed, a single-bend radiography tube is exchanged, and the loach guide wire is selected into the right rock sinus under the strong support of the radiography tube; the contrast tube is withdrawn, the guide catheter and the multifunctional contrast tube are coaxially exchanged, and the multifunctional contrast tube passes through the stricture of the infrontal sinus and brings the guide catheter into the infrontal sinus. The microcatheter is advanced along the guide catheter and withdrawn with the expandable anchoring structure-anchoring stent to a depth of about 30mm.
And (4) under the condition that the rock sinus is not developed, exploring the entrance of the rock sinus through a radiography guide wire or a loach guide wire, and guiding the microcatheter to enter the rock sinus deployment bracket according to the operation.
The second delivery lumen 31 of the microcatheter is guided by the proximal guidewire 51 of the anchoring member 52, i.e., moved along the guidewire 51 to the inferior petrosal sinus, the imaging marker position is observed, if the prescribed position is reached (if not reached, the position is adjusted), the tip of the penetrating catheter is pushed to migrate, penetrate the dura mater and arachnoid membrane, and enter the ventricle; the shunt 1 enters the brain pool together with the puncture catheter, when the puncture catheter exits, the shunt push rod is fixed, the shunt 1 is prevented from being carried out of the brain pool along with the puncture catheter, the shunt 1 fixing member 14, namely the adhesive, is adhered to the dura mater to form fixation, the shunt push tube and the microcatheter exit, and the guide wire 51 and the anchoring member 52 exit under the action of the auxiliary catheter.
Example two
As shown in fig. 10 and 11, a shunt system for treating hydrocephalus provided in a second embodiment of the present invention includes a shunt 1 and a delivery system, the delivery system including a piercing member 2, a first delivery member 3, and a guiding member 5; the distal portion 11 of the shunt 1 is provided with a fixation member 14, in particular a stent graft, and the proximal end is provided with a duckbill valve/membrane valve/double valve/single valve as a flow control member (not shown) to control the unidirectional flow of cerebrospinal fluid from the brain pool into the venous system.
In fig. 10, the puncture member body 21 is configured as a puncture catheter, during the delivery process, the shunt 1 is located in the puncture catheter cavity, and a limiter 23 is disposed in the puncture catheter distal tube as a second delivery member, where the limiter 23 forms a limit with the proximal end of the fixing member 14, so that the limiter pushes and deploys the shunt 1; in fig. 11, the inner wall of the distal end of the puncture catheter is provided with a necked-down section 24 as a second delivery member, the necked-down section 24 forming a stop with the proximal end of the fixation member 14, thereby pushing and deploying the shunt 1.
The embodiment is characterized in that: the shunt 1 can be pushed and deployed by the delivery system through the cooperation of the first delivery member 3 and the puncture member 2, a second delivery member is not needed, and the structure is simpler.
Example III
As shown in fig. 13, a shunt system for treating hydrocephalus provided in a third embodiment of the present invention includes a shunt 1 and a delivery system including a piercing member 2, a first delivery member 3, a second delivery member 4, and a guide member 5; the distal end portion 11 of the shunt 1 is provided with a fixation member 14, the fixation member 14 is in an expandable structure, a self-expanding stent is specifically selected, the self-expanding stent is provided with an isolation member 17 for isolating a ventricular system and a venous system, the isolation member 17 can be a thin film/a woven dense mesh/a dense wound mesh/a sac/a hydrophobic porous membrane, as shown in fig. 13, a thin film is used as the isolation member, and the thin film can be wrapped on the fixation member 14 to achieve a sealing effect between the ventricular system and the venous system. The proximal portion 12 is provided with a duckbill valve/membrane valve/double valve/single valve as a flow control member (not shown) to control the unidirectional flow of cerebrospinal fluid from the brain pool into the venous system.
The shunt 1 is located within a piercing member body 21 (employing a piercing catheter) and a second delivery member 4 (employing a shunt pusher) that is provided with a piercing tip 22 at a distal end thereof, the shunt pusher being operable to urge the shunt body 13 to move and deploy. The first delivery member 3 (delivery catheter) is a dual lumen delivery catheter, wherein the first delivery lumen 31 accommodates the puncture catheter 21 and the second delivery lumen 32 accommodates the guide wire 51 of the guide member 5, the guide wire 51 is a flat guide wire, and the distal end of the second delivery lumen 32 of the first delivery member 3 (delivery catheter) is disposed at a distance from the first delivery lumen 31, specifically, the distance is 3-20mm.
This embodiment is substantially the same as the above embodiment in a way, except that the fixing member 14 is an inflatable structure (pressurizing structure), and the fixing member 14 is provided with an isolation member 17 for isolating the ventricular system and the venous system to improve sealability.
In the description of the present specification, reference to the terms "one embodiment," "some embodiments," "examples," "particular examples," or "an alternative embodiment," etc., means that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiments or examples. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.
The above-described embodiments do not limit the scope of the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the above embodiments should be included in the scope of the present invention.
Claims (31)
1. A shunt for treating hydrocephalus, comprising a distal portion provided with a cerebrospinal fluid inlet for deployment in a ventricular system of a patient, a proximal portion provided with a cerebrospinal fluid outlet for deployment in a venous system of the patient, and a tube communicating the distal portion and the proximal portion for draining cerebrospinal fluid from the ventricular system to the venous system, characterized by: the distal portion is provided with a fixation member that is in contact engagement with the dura mater and/or the arachnoid puncture to increase the contact force and/or friction and/or adhesion between the distal portion and the puncture, when or after the distal portion is deployed in the patient's ventricular system, such that the distal portion is fixedly and/or limitedly deployed in the patient's ventricular system by the fixation member.
2. A shunt for treating hydrocephalus according to claim 1 wherein: the fixing component adopts an adhesive, a friction increasing structure and/or a pressurizing structure;
The adhesive is configured to improve adhesion between the shunt and the puncture such that the distal portion is secured and/or limitedly deployed in the ventricular system of the patient by the adhesion provided by the securing member;
the friction enhancing structure is configured to enhance friction between the shunt and the puncture such that the distal portion is secured and/or limitedly deployed in the ventricular system of the patient by friction provided by the securing member;
the pressurization structure is configured to increase contact pressure between the shunt and the puncture such that the distal portion is secured and/or limited for deployment in the ventricular system of the patient by the contact pressure provided by the securing member.
3. A shunt for treating hydrocephalus according to claim 2 wherein: the adhesive is hydrogel or medical adhesive.
4. A shunt for treating hydrocephalus according to claim 2 wherein: the adhesive is deployed at the distal portion by means of a pre-positioning or intra-operative filling;
the filling mode in the operation is as follows: a filling port is arranged at the pre-deployment position of the fixing member, and the adhesive is filled to the pre-deployment position through the filling port by a filling pipe to form the fixing member.
5. A shunt for treating hydrocephalus according to claim 2 wherein: the friction increasing structure adopts one or a combination of a microstructure, a porous structure, a thread structure, a hydrophilic microstructure, a multi-ring structure and a twill structure which increase friction coefficient.
6. A shunt for treating hydrocephalus according to claim 2 wherein: the pressurization structure is an expandable structure.
7. A shunt for treating hydrocephalus according to claim 6 wherein: the inflatable structure adopts one or a combination of a self-expanding bracket, a water-absorbing inflatable structure and a self-expanding balloon.
8. A shunt for treating hydrocephalus according to claim 6 wherein: the expandable structure is provided with an isolation member for isolating the ventricular system from the venous system.
9. A shunt for treating hydrocephalus according to claim 8 wherein: the isolating member is one or a combination of a film, a woven dense net, a dense winding net, a bag and a hydrophobic porous film.
10. A shunt for treating hydrocephalus according to claim 1 wherein: the shape of the fixing member is a non-smooth circle.
11. A shunt for treating hydrocephalus according to claim 1 wherein: the fixation member includes a pro-cell adhesion/proliferation, anti-inflammatory structure or component for promoting engagement of the stoma/puncture with the fixation member or controlling inflammation of the stoma/puncture upon or after deployment of the distal portion in the ventricular system of a patient.
12. A shunt for treating hydrocephalus according to claim 1 wherein: the shunt further comprises a limiting part arranged between the proximal part and the ventricle system, wherein the limiting part is configured to have a radial dimension larger than that of the anastomotic stoma/puncture to limit the proximal part from entering the ventricle system;
and/or the shunt further comprises a shielding protection disposed at a proximal portion thereof, the shielding protection configured to isolate endothelial cells of the venous system from the outlet of the proximal portion for outputting cerebrospinal fluid.
13. A shunt for treating hydrocephalus according to claim 1 wherein: the partial surface or the whole surface of the shunt is provided with an anticoagulant layer and/or a polymer liner capable of inhibiting adhesion of the surface of the shunt with protein and/or cells; the partial or all surfaces of the diverter comprise an outer surface or an inner surface of the diverter, wherein the inner surface of the cavity is a partial or all inner surface of the cavity;
And/or the shunt includes at least one radiopaque marker positioned at the distal portion, or the tube, or the proximal portion, or the fixation member, or a combination thereof.
14. A shunt for treating hydrocephalus according to claim 1 wherein: the tube body forms a shunt cavity which is communicated with the inlet of the distal end part and the outlet of the proximal end part, and a flow control component which only allows cerebrospinal fluid to flow into the outlet of the proximal end part from the inlet of the distal end part is arranged in the shunt cavity;
and/or the shunt is provided with a control flow member, the control flow member being provided at the distal portion and/or the proximal portion;
and/or the shunt is provided with a semi-permeable membrane for restricting the flow, diffusion or exchange of a portion of the components in the ventricular and venous systems.
15. A shunt for treating hydrocephalus according to claim 14 wherein: the flow direction control member is configured as one of a check valve, a check flow surface, a check flow passage, or a combination thereof that restricts flow direction.
16. A shunt system for treating hydrocephalus, characterized by: comprising a delivery system and the shunt of any one of claims 1-15; the delivery system is configured to introduce the shunt into the patient through the venous system and to guide the shunt into the venous system and the ventricular system of the patient.
17. A shunt system for treating hydrocephalus according to claim 16 wherein: the delivery system includes a piercing member, a first delivery member, and a guide member;
the puncture member is provided with a puncture tip, and the puncture member penetrates into a patient through the puncture tip to enable a venous system and a ventricle system of the patient to form a puncture opening for the shunt to pass through;
the first delivery member is configured to deliver the piercing member and/or the shunt to a specified location in the venous system with the assistance of a guide member.
18. A shunt system for treating hydrocephalus according to claim 17 wherein: the distal end of the first delivery member and/or the piercing member directs the piercing tip into contact with dural tissue.
19. A shunt system for treating hydrocephalus according to claim 17 wherein: the distal end of the main body part of the puncture member is provided with a hypotube structure;
and/or the puncture tip is arranged as a bevel blade needle, a Kunker needle, a half-blade needle, a willow-leaf needle, a pen-point needle or a radio-frequency probe;
and/or the piercing tip and/or piercing member body are provided with a radiopaque marker.
20. A shunt system for treating hydrocephalus according to claim 17 wherein: the guide member is in guide connection with the first delivery member and/or the puncture member, and guides the first delivery member and/or the puncture member to move in a specific direction and position so that the shunt is delivered to a specific position in the venous system; the guide member is located within the first conveying member.
21. A shunt system for treating hydrocephalus according to claim 20 wherein: the first conveying member is a conveying conduit;
the delivery catheter has a first delivery lumen that directs movement of the penetrating member and shunt toward the ventricular system;
and a second delivery lumen in guided connection with the guide member.
22. A shunt system for treating hydrocephalus according to claim 17 wherein: the guide member is configured as one or a combination of a guidewire, or a distal shapeable microcatheter, or a guide catheter, or a contrast catheter, or a catheter with a single-sided balloon, or a stent or balloon with a lumen, or a stent with a guidewire.
23. A shunt system for treating hydrocephalus according to claim 17 wherein: the guide member is distally provided with an anchoring member for securing the guide member in the venous system.
24. A shunt system for treating hydrocephalus according to claim 17 wherein: the delivery system further includes a second delivery member configured to grip or push or pull or stop the shunt, configured to deliver and/or deploy a distal portion of the shunt at a specified location in the venous system into the ventricular system.
25. A shunt system for treating hydrocephalus according to claim 24 wherein: the piercing member is disposed at a distal end of the first delivery member, or a distal end of the second delivery member, or a distal end of the shunt, or a distal end of the guide member, or the piercing member is configured as a piercing catheter.
26. A shunt system for treating hydrocephalus according to claim 24 wherein: the second conveying component is a shunt tube push rod, and the proximal end part of the shunt tube push rod is connected into the first conveying component and is contacted with the limiting part of the shunt so as to push the shunt and/or the puncture component to move towards the ventricle system.
27. A shunt system for treating hydrocephalus according to claim 24 wherein: the delivery system includes at least one radiopaque marker positioned on one or a combination of the first delivery member, or the second delivery member, or the piercing member, or the guide member.
28. A shunt system for treating hydrocephalus according to claim 17 wherein: the delivery system further includes a stop member configured to limit a penetration distance of the penetration member and/or a deployment depth of the shunt.
29. A shunt system for treating hydrocephalus according to claim 28 wherein: the stop member is coupled to the first delivery member proximal end for snap-fit engagement with the body proximal end of the piercing member.
30. A shunt system for treating hydrocephalus according to claim 17 wherein: some or all of the components of the delivery system are in an orientable curved configuration.
31. A shunt system for treating hydrocephalus according to claim 16 wherein: the system includes an operating handle to which the proximal ends of some or all of the components of the delivery system are connected, the operating handle being used to operate the delivery system, and/or the shunt.
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WO2025108317A1 (en) * | 2023-11-24 | 2025-05-30 | 通桥医疗科技有限公司 | Shunt for treating hydrocephalus and system thereof |
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