CN113599663B - Vascular implantable drug infusion catheter - Google Patents

Vascular implantable drug infusion catheter Download PDF

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Publication number
CN113599663B
CN113599663B CN202110926542.1A CN202110926542A CN113599663B CN 113599663 B CN113599663 B CN 113599663B CN 202110926542 A CN202110926542 A CN 202110926542A CN 113599663 B CN113599663 B CN 113599663B
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CN
China
Prior art keywords
piezoelectric element
expandable mesh
infusion catheter
drug infusion
fixing
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Application number
CN202110926542.1A
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Chinese (zh)
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CN113599663A (en
Inventor
杨邓飞
高猛
叶乐
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Advanced Institute of Information Technology AIIT of Peking University
Hangzhou Weiming Information Technology Co Ltd
Original Assignee
Advanced Institute of Information Technology AIIT of Peking University
Hangzhou Weiming Information Technology Co Ltd
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Application filed by Advanced Institute of Information Technology AIIT of Peking University, Hangzhou Weiming Information Technology Co Ltd filed Critical Advanced Institute of Information Technology AIIT of Peking University
Priority to CN202110926542.1A priority Critical patent/CN113599663B/en
Publication of CN113599663A publication Critical patent/CN113599663A/en
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0074Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
    • A61M25/0075Valve means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M2025/0001Catheters; Hollow probes for pressure measurement
    • A61M2025/0002Catheters; Hollow probes for pressure measurement with a pressure sensor at the distal end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0074Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
    • A61M25/0075Valve means
    • A61M2025/0076Unidirectional valves

Abstract

The application relates to the technical field of medical appliances, and in particular discloses a vascular implantable drug infusion catheter, which comprises: the tube body is provided with a distal end and a proximal end, and a drug delivery channel; the one-way valve assembly comprises a tubular expandable mesh sleeve and a piezoelectric element arranged on the inner surface of the expandable mesh sleeve, wherein the expandable mesh sleeve is provided with a first fixed end and an expansion end which are oppositely arranged, the piezoelectric element is provided with a second fixed end and a movable end which are oppositely arranged, the expansion end is driven by the movable end to expand or contract, and the aperture of a mesh hole on the expandable mesh sleeve is smaller than a medicament molecule and larger than a blood cell; the first fixing end and the second fixing end are fixed on the pipe body through the fixing ring; the pressure sensor is arranged at the far end of the tube body; and the controller is connected with the pressure sensor and the piezoelectric element. The one-way valve is realized by expanding or contracting the expandable mesh sleeve under the drive of the piezoelectric element, and can prevent medicament molecules from flowing back.

Description

Vascular implantable drug infusion catheter
Technical Field
The application relates to the technical field of medical appliances, and particularly discloses a vascular implantable drug infusion catheter.
Background
Vascular embolism is one of the main modes of targeted treatment of tumors, and an embolic agent (or a tumor-targeted drug) is percutaneously punctured into a blood vessel by a perfusion catheter, is injected into an arterial vessel near the upstream of the tumor, plugs the blood vessel, and cuts off arterial blood supply of the tumor, thereby achieving the purpose of treating the tumor. The existing embolic agent injection method mainly comprises the steps of observing by an operator under the assistance of an external imaging instrument, and releasing the embolic agent at a target position through a perfusion catheter, but because the embolic agent is often sticky and needs to be perfused under high pressure, obvious jet flow is formed when the embolic agent is released in a blood vessel. After the jet embolic agent reaches the embolic position, the in-situ blood is extruded back to the upstream of the arterial blood vessel (the tumor direction blood vessel becomes thin and has high flow resistance), and enters the upstream small blood vessel. The backflow of blood cannot avoid the mixing of partial embolic agent, and the backflow embolic agent blocks the upstream small blood vessels, so that the ischemia damage of healthy tissue cells can be caused.
The existing catheter infusion technology mostly utilizes spring bias technology to integrate a nickel-titanium alloy valve at the catheter infusion port. In the embolic agent perfusion process, an operator controls the external handle and mechanically moves the valve through the guide wire in the catheter to open the valve, the pore diameter of the porous membrane on the valve is larger than that of blood cells and smaller than that of embolic agent, so that blood can flow back normally to prevent the embolic agent from flowing back, and thus all the embolism of the embolic agent can be controlled to be blocked at a target position, and the damage of the embolic agent flowing back to normal tissue cells is avoided. However, the perfusion catheter has single function, larger volume and slower response, and can not acquire the hemodynamic change condition in the embolism process in real time.
Disclosure of Invention
The present application aims to solve, at least to some extent, the above-described technical problems in the related art. Therefore, the application provides a vascular implantable drug infusion catheter, which solves at least one technical problem.
In order to achieve the above object, the present application provides an implantable vascular drug infusion catheter comprising:
a tube having a distal end and a proximal end, the tube having a drug delivery channel;
the one-way valve assembly comprises a tubular expandable mesh sleeve and a piezoelectric element arranged on the inner surface of the expandable mesh sleeve, wherein the expandable mesh sleeve is provided with a first fixed end and an expansion end which are oppositely arranged, the piezoelectric element is provided with a second fixed end and a movable end which are oppositely arranged, the expansion end is driven by the movable end to expand or contract, and the aperture of a mesh hole on the expandable mesh sleeve is smaller than a medicament molecule and larger than a blood cell;
the first fixing end and the second fixing end are fixed on the pipe body through the fixing ring;
the pressure sensor is arranged at the far end of the tube body;
and the controller is connected with the pressure sensor and the piezoelectric element.
In addition, the vascular implantable drug infusion catheter of the present application may also have the following additional technical features:
according to some embodiments of the application, the piezoelectric element is disposed along an axial direction of the expandable mesh, and the movable end of the piezoelectric element is capable of bending away from the axis of the expandable mesh.
According to some embodiments of the application, the inner circumferential surface of the expandable mesh is provided with a plurality of piezoelectric elements at intervals.
According to some embodiments of the application, the piezoelectric element is curved and located at the expansion end of the expandable mesh and along the circumference of the expandable mesh, and the movable end of the piezoelectric element is capable of being deformed by moving in a direction away from the axis of the expandable mesh.
According to some embodiments of the application, the piezoelectric element comprises an upper electrode, a lower electrode, and a piezoelectric material selected from PZT, PVDF, baTiO 3 At least one of PVDF-TrFE and ZnO.
According to some embodiments of the application, the piezoelectric element is cross-shaped.
According to some embodiments of the application, the expandable mesh is made of a polymeric fiber membrane material having a young's modulus of elasticity of not less than 50MPa and a pore size of not more than 400 μm.
According to some embodiments of the application, the polymeric fiber film material is selected from cellulose-based, polyamide-based or polyethersulfone-based materials.
According to some embodiments of the application, the mesh of the expandable mesh is diamond-shaped or circular.
According to some embodiments of the application, the fixing device further comprises a fixing bracket for fixing the first fixing end and the second fixing end, and the fixing ring is used for fixing the first fixing end and the second fixing end on the pipe body through the fixing bracket.
Compared with the prior art, the application has the following beneficial effects:
the one-way valve on the vascular implantable drug infusion catheter is realized by expanding or contracting the expandable mesh sleeve under the drive of the piezoelectric element, so that the embolic agent can be prevented from flowing into blood supply vessels of normal tissue cells along with backflow blood in the high-pressure infusion process, the pressure sensor can monitor the embolic agent infusion and backflow conditions in the blood vessels in real time, and the controller can control the piezoelectric element to vibrate according to the pressure data of the pressure sensor, so that the expandable mesh sleeve can be expanded or contracted, and the embolic agent targeting infusion can be accurately guided by an auxiliary imaging means.
Drawings
In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described, and it is obvious that the drawings in the following description are only some embodiments of the present application, and other drawings may be obtained according to the structures shown in these drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic illustration of an unexpanded configuration of an implantable vascular drug infusion catheter according to one embodiment of the present application;
FIG. 2 is a schematic view of the assembled fixed stent and expandable mesh of FIG. 1;
FIG. 3 is a schematic diagram of the piezoelectric element in FIG. 1;
FIG. 4 is a schematic view of the expandable mesh sleeve of FIG. 1 after expansion;
FIG. 5 is a deformation diagram of the piezoelectric element of FIG. 1;
FIG. 6 is a schematic illustration of an unexpanded configuration of an implantable vascular drug infusion catheter according to another embodiment of the present application;
FIG. 7 is a schematic illustration of the expandable mesh sleeve of FIG. 6 after expansion;
fig. 8 is a deformation diagram of the piezoelectric element in fig. 7.
The achievement of the objects, functional features and advantages of the present application will be further described with reference to the accompanying drawings, in conjunction with the embodiments.
Detailed Description
The present application will be described in further detail with reference to the drawings and examples, in order to make the objects, technical solutions and advantages of the present application more apparent. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the application.
In the field of interventional medical devices, the end of a medical device implanted in a human or animal body closer to an operator is generally referred to as a "proximal end", the end farther from the operator is generally referred to as a "distal end", and the "proximal end" and the "distal end" of any component of the medical device are defined according to this principle. "axial" generally refers to the longitudinal direction of a medical device when delivered, and "radial" generally refers to the direction of the medical device perpendicular to its "axial" direction, and defines the "axial" and "radial" directions of any component of the medical device in accordance with this principle.
The technical scheme of the application will be further described in detail below with reference to specific examples.
Referring to fig. 1-8, an embodiment of the present application provides a vascular implantable drug infusion catheter 100 for treating tumors, wherein the vascular implantable drug infusion catheter 100 can be percutaneously inserted into a blood vessel 200 to inject a medicament, such as an embolic agent, in the vascular implantable drug infusion catheter 100 into tumor tissue. The vascular implantable drug infusion catheter 100 comprises a catheter body 10, a one-way valve assembly, a fixed ring 11, a pressure sensor 12 and a controller, wherein the one-way valve assembly is used for preventing drug molecules 300 from flowing into blood supply vessels of normal tissue cells along with backflow blood in a high-pressure infusion process, the catheter body 10 is provided with a distal end and a proximal end, a pipeline 101 for conveying the drug towards a target position is formed in the catheter body 10, the one-way valve assembly is arranged at the distal end of the catheter body 10, the pressure sensor 12 is arranged at the distal end of the catheter body 10, a metal lead of the one-way valve assembly and the pressure sensor 12 can be integrated in an inner cavity of the catheter body 10 or in a groove on the surface of the catheter body 10, the metal lead of the one-way valve assembly and the pressure sensor 12 can be led out of the outer joint of the catheter body 10 after being glued and packaged and fixed, the one-way valve assembly comprises a tubular expandable mesh 13, a fixed support 14 and a piezoelectric element 15 arranged on the inner surface of the expandable mesh 13, the expandable mesh 13 has a pore diameter smaller than the drug molecules and larger than the blood cells, the expandable mesh 13 is provided with a first fixed end 130 and a terminal 131 arranged oppositely, the fixed end 131 is arranged at the second fixed end 15 and a second fixed end 150 is arranged oppositely to the fixed end of the piezoelectric element 151 and the piezoelectric element is connected with the piezoelectric sensor 12 at the second fixed end 151 or the surface of the piezoelectric sensor 12 through the fixed end 151 and the fixed end 151.
Further, with continued reference to fig. 2, the fixing bracket 14 fixes the first fixing end 130 and the second fixing end 150, and the fixing ring 11 fixes the first fixing end 130 and the second fixing end 150 to the pipe body 10 through the fixing bracket 14. Specifically, after the fixing bracket 14 fixes the first fixing end 130 and the second fixing end 150, the fixing bracket 14 is closely attached to the fixing ring 11, so as to fix the check valve assembly on the pipe body 10.
In the embodiment of the present application, the opening/closing of the check valve assembly is achieved by driving the expansion and contraction of the expandable mesh 13 by the piezoelectric element 15, so that the problem of preventing backflow after the release of the medicine molecules 300 is achieved.
Specifically, the expansion end 131 of the expandable mesh 13 is arranged close to the distal end of the tube body 10, the pressure sensor 12 can acquire pressure data in the blood vessel 200 in real time, monitor the infusion and reflux conditions of embolic agent in the blood vessel 200 in real time, and transmit the acquired pressure data to the controller, the controller controls the on/off of the piezoelectric element 15 according to the pressure data in the blood vessel 200, when the piezoelectric element 15 is controlled to be on, the movable end of the piezoelectric element 15 can deform, so as to drive the expansion end 131 of the expandable mesh 13 to expand, realize the opening of the one-way valve assembly, further prevent the reflux of the drug, and influence the normal operation of other blood vessels; correspondingly, when the piezoelectric element 15 is controlled to be closed, the movable end of the piezoelectric element 15 is restored to the original shape, and the expansion end 131 of the expandable mesh 13 is contracted under the driving of the piezoelectric element 15 until the movable end is restored to the original position, so that the closing of the one-way valve assembly is realized.
It should be noted that the expandable mesh 13 is made of a polymer fiber film material with certain elastic expansion and rigidity, the polymer fiber film material has young's elastic modulus not less than 50MPa, the mesh on the expandable mesh 13 is not limited to diamond, round, etc., the pore size can be changed according to the size of the drug molecule, but not less than the sizes of red blood cells and white blood cells in blood pressure, so that blood tissues can pass smoothly, and the pressure in blood vessels is kept within normal values. Specifically, in the present embodiment, the mesh aperture of the expandable mesh 13 is not more than 400 μm, and the mesh aperture of the expandable mesh 13 is smaller than the drug molecule 300 and larger than the sizes of red blood cells and white blood cells, so that when the expansion end 131 of the expandable mesh 13 expands, the expansion end 131 can only allow blood cells to pass smoothly while blocking the drug molecule 300 from passing therethrough, thereby achieving the prevention of the backflow of the drug molecule 300.
In this embodiment, the material of the pipe body 10 may be polyethylene, polypropylene, nylon, polyether ether ketone, polytetrafluoroethylene, polyoxymethylene, ABS, PBT, or polyphenylene sulfide.
The sensing principle of the pressure sensing device 12 in this embodiment is not limited to piezoresistance, capacitance, piezoelectricity, etc., and when the expandable mesh 13 expands and contracts, the pressure sensing device 12 measures the pressure in the blood vessel in real time to better guide the external perfusion operation and the accurate control of the piezoelectric element, and in order to avoid the influence of the pressure sensor 12 on the blood tissue, the surface of the pressure sensing device 12 may be coated and encapsulated.
With continued reference to fig. 3-8, the movable end 151 of the piezoelectric element 15 in this embodiment has a cross shape, and includes an upper electrode 152, a lower electrode, and a piezoelectric material 153 with a certain deformability and rigidity, where the piezoelectric material 151 is at least one selected from PZT, PVDF, baTiO, PVDF-TrFE, and ZnO. Specifically, an electrical signal is applied to the piezoelectric element 15, the piezoelectric element 15 can vibrate periodically according to the inverse piezoelectric effect, so as to drive the expandable mesh to expand and contract, and the piezoelectric element 15 has better biocompatibility.
It should be noted that the vibration direction of the piezoelectric element 15 may be classified into a thickness direction (d 33), a shear direction (d 15), a length direction (d 31), and the like, and in this embodiment, the vibration direction of the piezoelectric element 15 is mainly the length direction (d 31). Specifically, in some embodiments of the present application, as shown in fig. 4-5, the piezoelectric element 15 is disposed along the axial direction of the expandable mesh 13, and the movable end 151 of the piezoelectric element 15 is capable of bending away from the axis of the expandable mesh 13. Specifically, the movable end 151 of the piezoelectric element 15 drives the expansion end 131 of the expandable mesh 13 to expand during the bending process, otherwise, the movable end 151 of the piezoelectric element 15 restores the original shape to drive the expansion end 131 of the expandable mesh 13 to contract.
In some embodiments of the present application, as shown in fig. 6-8, the piezoelectric element 15 is curved and positioned at the expansion end 131 of the expandable mesh 13 and along the circumference of the expandable mesh 13, and the movable end 151 of the piezoelectric element 15 is capable of being deformed by movement in a direction away from the axis of the expandable mesh 13. Specifically, the movable end 151 of the piezoelectric element 15 can move in a direction far away from the axis of the expandable mesh 13 and is gradually in a flat state, at this time, the piezoelectric element 15 drives the expandable end 131 of the expandable mesh 13 to slowly expand and contact with the inner wall of the blood vessel 200, so as to avoid damage to the inner wall of the blood vessel 200, otherwise, the movable end 151 of the piezoelectric element 15 restores to a curved shape and drives the expandable end 131 of the expandable mesh 13 to contract.
The present application is not limited to the above-mentioned embodiments, and any changes or substitutions that can be easily understood by those skilled in the art within the technical scope of the present application are intended to be included in the scope of the present application. Therefore, the protection scope of the present application shall be subject to the protection scope of the claims.

Claims (10)

1. A vascular implantable drug infusion catheter, comprising:
a tube having a distal end and a proximal end, the tube having a drug delivery channel;
the one-way valve assembly comprises a tubular expandable mesh sleeve and a piezoelectric element arranged on the inner surface of the expandable mesh sleeve, wherein the expandable mesh sleeve is provided with a first fixed end and an expansion end which are oppositely arranged, the piezoelectric element is provided with a second fixed end and a movable end which are oppositely arranged, the expansion end is driven by the movable end to expand or contract, and the aperture of a mesh hole on the expandable mesh sleeve is smaller than a medicament molecule and larger than a blood cell;
the first fixing end and the second fixing end are fixed on the pipe body through the fixing ring;
the pressure sensor is arranged at the far end of the tube body;
and the controller is connected with the pressure sensor and the piezoelectric element.
2. The vascular implantable drug infusion catheter of claim 1, wherein the piezoelectric element is disposed along an axial direction of the expandable mesh, the movable end of the piezoelectric element being bendable away from the expandable mesh axis.
3. The vascular implantable drug infusion catheter according to claim 2, wherein the expandable mesh is provided with a plurality of piezoelectric elements arranged at intervals on an inner peripheral surface thereof.
4. The vascular implantable drug infusion catheter according to claim 1, wherein the piezoelectric element is curved and is located at an expanded end of the expandable mesh and is disposed along a circumferential direction of the expandable mesh, and wherein a movable end of the piezoelectric element is capable of being deformed by movement in a direction away from an axis of the expandable mesh.
5. The vascular implantable drug infusion catheter of claim 1, wherein the piezoelectric element comprises an upper electrode, a lower electrode, and a piezoelectric material between the upper electrode and the lower electrode, the piezoelectric material selected from PZT, PVDF, baTiO 3 At least one of PVDF-TrFE and ZnO.
6. The vascular implantable drug infusion catheter according to claim 1, wherein the piezoelectric element is cross-shaped.
7. The vascular implantable drug infusion catheter according to claim 1, wherein the expandable mesh is made of a polymer fiber membrane material having young's modulus of elasticity of not less than 50MPa and pore size of not more than 400 μm.
8. The vascular implantable drug infusion catheter according to claim 7, wherein the polymer fiber film material is selected from cellulose-based, polyamide-based or polyethersulfone-based materials.
9. The vascular implantable drug infusion catheter of claim 1, wherein the mesh of the expandable mesh is diamond-shaped or circular.
10. The vascular implantable drug infusion catheter according to any one of claims 1 to 9, further comprising a fixing bracket fixing the first fixing end and the second fixing end, wherein the fixing ring fixes the first fixing end and the second fixing end to the tube body through the fixing bracket.
CN202110926542.1A 2021-08-12 2021-08-12 Vascular implantable drug infusion catheter Active CN113599663B (en)

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Application Number Priority Date Filing Date Title
CN202110926542.1A CN113599663B (en) 2021-08-12 2021-08-12 Vascular implantable drug infusion catheter

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CN113599663B true CN113599663B (en) 2023-10-20

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Citations (3)

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Publication number Priority date Publication date Assignee Title
CN106456868A (en) * 2014-03-25 2017-02-22 神火医药公司 Closed tip dynamic microvalve protection device
CN110831642A (en) * 2017-03-20 2020-02-21 神火医药公司 Dynamically reconfigurable microvalve protection device
CN112316276A (en) * 2020-12-03 2021-02-05 珠海通桥医疗科技有限公司 Micro-catheter

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Publication number Priority date Publication date Assignee Title
US9539081B2 (en) * 2009-12-02 2017-01-10 Surefire Medical, Inc. Method of operating a microvalve protection device
US8696698B2 (en) * 2009-12-02 2014-04-15 Surefire Medical, Inc. Microvalve protection device and method of use for protection against embolization agent reflux
US9126016B2 (en) * 2010-05-19 2015-09-08 Nfusion Vascular Systems Llc Augmented delivery catheter and method
US20190298983A1 (en) * 2018-01-15 2019-10-03 Surefire Medical, Inc. Injection Port for Therapeutic Delivery

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106456868A (en) * 2014-03-25 2017-02-22 神火医药公司 Closed tip dynamic microvalve protection device
CN110831642A (en) * 2017-03-20 2020-02-21 神火医药公司 Dynamically reconfigurable microvalve protection device
CN112316276A (en) * 2020-12-03 2021-02-05 珠海通桥医疗科技有限公司 Micro-catheter

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