CN108042899A - A kind of dual valve implantable drug delivery system - Google Patents

A kind of dual valve implantable drug delivery system Download PDF

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Publication number
CN108042899A
CN108042899A CN201810069977.7A CN201810069977A CN108042899A CN 108042899 A CN108042899 A CN 108042899A CN 201810069977 A CN201810069977 A CN 201810069977A CN 108042899 A CN108042899 A CN 108042899A
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CN
China
Prior art keywords
valve
drug delivery
conduit
delivery system
implantable drug
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201810069977.7A
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Chinese (zh)
Inventor
张海军
段翠海
李宜玮
刘光
王新坤
侯文博
周超
尹玉霞
鲁守涛
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Shandong Branden Medical Devices Co Ltd
Original Assignee
Shandong Branden Medical Devices Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shandong Branden Medical Devices Co Ltd filed Critical Shandong Branden Medical Devices Co Ltd
Priority to CN201810069977.7A priority Critical patent/CN108042899A/en
Publication of CN108042899A publication Critical patent/CN108042899A/en
Pending legal-status Critical Current

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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
    • A61M25/10Balloon catheters
    • 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/84Drainage tubes; Aspiration tips
    • 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
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • 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
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/005Devices for introducing or retaining media, e.g. remedies, in cavities of the body for contrast media
    • 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
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/105Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
    • 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
    • A61M2210/00Anatomical parts of the body
    • A61M2210/12Blood circulatory system

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Vascular Medicine (AREA)
  • Surgery (AREA)
  • Child & Adolescent Psychology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

The present invention relates to a kind of dual valve implantable drug delivery systems, belong to medical instrument and field of medical materials.The implantable drug delivery system body is made of injection seat and connecting conduit, and injection seat is a hollow liquid storage warehouse, and passes through diaphragm and be connected with conduit.The front end valve of the system is located at the head end of conduit;Rear end valve is located at liquid storage warehouse and catheter connector position, i.e. notch on diaphragm.The system is applicable to tissue and Intravascular infusions chemotherapeutics, and when being operated without infusion or pumpback, valve is closed;It is infused or during pumpback, valve is opened.Another design concept of the system is to apply in local chemotherapy, it can additional closed sacculus in the head end of conduit, for storing radiotherapeutic drug, to realize the local treatment to tumour, the design of dual valve can prevent radiotherapy and chemotherapy medicine from, by sacculus reflux to conduit or liquid storage warehouse, avoiding damage of the radiotherapy and chemotherapy medicine leakage to human cuticular tissue.

Description

A kind of dual valve implantable drug delivery system
Technical field
The invention belongs to medical instruments and field of medical materials, and in particular to and it is a kind of that there is dual valve, can effectively it prevent The only implantable drug delivery system of drug and blood back flow.
Background technology
In traditional medical procedure, artery administration, injection contrast agent, venous blood collection, anticancer radiotherapy and chemotherapy medicine whole body or office Portion is administered and cranial cavity, thoracic cavity, and the treatment of intraperitoneal drainage takes plug in duct to carry out more, the treatment side of this direct cannulation There are the problems such as easy infection, inconvenient, poor reliability, obstruction patient activity for formula.In the middle and later periods in 20th century, face both at home and abroad Gradually using the device of a kind of implantable in vivo administration or drainage on bed, to solve the above problems.But this device is using The problems such as often occurring the problem of drug and blood back flow in the process, and causing infection, plugging, thrombus, endangers patient health.For Infection caused by can effectively prevent adverse current and damage of the radiotherapy and chemotherapy medicine to patient is reduced, the present invention, which proposes one kind, to be had Dual valve, it can prevent the implantable drug delivery system backflowed.
Patent CN200998518Y describes a kind of micro-wound implanting type radiotherapy bursa, and device is made of three parts:Liquid reservoir is led Pipe and storage anther sac.Liquid reservoir is hollow, oblate body, is connected with conduit.Catheter tip has several apertures, and end is by storage anther sac bag It wraps up in.Liquid reservoir and conduit are made of silica gel, and liquid reservoir bottom liner is with thin stainless steel gasket.Reservoir is good by soft texture, elasticity Good genuine milk rubber film is made, and wraps up catheter tip, forms closed blister cavities.Radionuclide can be imported using the device Tumor by local.
Implantable drug delivery system described in patent CN201710803U discloses a kind of pump body structure, by gland and pedestal structure It is in the wide inswept in rear end into, pedestal shape, central thick surrounding edge is flat thin, and by width to narrow and by thickness to thin streamlined mistake The form crossed, the edge of pedestal are uniformly distributed there are three threading hole, and the middle part of base inner wall is equipped with step, is stamped and wears on step Pierce membrane, pedestal and puncture and form chamber between membrane, gland is arranged on the edge for puncturing membrane, the bottom of gland be equipped with to The collar of lower extension, collar is closely between the side wall at base openings end and puncture membrane.The patent advantage is:It is not easy to ooze Leakage, it is solid and reliable.
Implanted peri-operative central venous infusion port disclosed in United States Patent (USP) US2011/0004167A1, port body structure and patent CN201710803U is similar, and vein blood vessel is inserted in connecting conduit cooperation seal wire use, for chemotherapy or parenteral nutrition is needed to supplement Patient's long-time service and patent CN206007700U provide a kind of full-implantation type venous transfusion port, for the defeated of puncture Cylindric port body made of all silica gel in liquid port, entire port body can enter the entry point of body cavity as puncture needle, be implanted into skin Transfusion port position need not be ajusted after lower, greatly improves puncture success rate.
The paper " chemotherapy of mesenchyma stroma of pernicious cerebral glioma " of Li Anmin et al. is published in《Chinese Clinical neurosurgery is miscellaneous Will》, 1999,3, patient's encephalic is imbedded at using silica gel material brain colloid chemotherapy capsule in paper, malignant glioma is realized anti- Multiple administration.Medical grade silicon rubber is the chemotherapy capsule of material, and histocompatbility is good, no antigen, high pressure resistant disinfection, anti-aging, Elasticity is good, through external 300 no leakages of puncture test.Storage can be buried for a long time in vivo, repeat administration is easy.
Involved implantation infusion device in more than patent and document, is no valve structure or single valve structure, Blood and drug adverse current can not be effectively solved the problems, such as in actual Clinical practice.With the extension of Implantation Time, easily occur by In the severe complications such as infection, plugging and thrombus caused by blood and drug adverse current.The present invention is in conduit or sacculus Liquid reflux problem, it is proposed that a kind of implantable drug delivery system with dual valve can effectively prevent drug reflux.
The content of the invention:
The present invention relates to a kind of dual valve implantable drug delivery system, feature is that main body is made of injection seat connecting conduit, Injection seat generally silica gel material has good histocompatbility, and it is comfortable to be implanted into body-sensing;It is worn at the top of injection seat for an arc Thorn is every puncturing and punctured and no leakage repeatedly every tolerable syringe needle;Injection seat internal cavities are communicated with conduit, and cavity bottom sets anti- The gasket 5 that only syringe needle penetrates, material can be but be not limited to pure titanium, titanium alloy, stainless steel, platinum, polysulfones etc. and can stop point The metal or rigid plastics of sharp pin puncture.
It is an advantage of the present invention that set valve respectively in the front and back end of the conduit, catheter proximal end is blind end, front end Valve may be disposed at apart from port nearby, generally along the elongated streamline of conduit extending direction, shape such as " one " type, " two " type, " three " type;Rear end of conduit is connected with injection seat, connecting portion there are one being socketed in diaphragm on rear end of conduit mouth, Diaphragm membrane material can be silica gel, flexibel polyurethane, thermoelastic etc..
Valve is arranged on diaphragm using technologies such as laser cutting, physics cuttings, and is set according to different demands The valve of different shape and size, such as " one " type, " ten " type, " two " type, " three " type, " " type, " ÷ " type.
Second design that this patent is specifically related to is applied in local chemotherapy, and closed sacculus can be socketed in catheter proximal end, Balloon features can be the suitable models such as spherical, cylindrical, elliposoidal, irregular shape, for storing drug, realize to tumour Local treatment, the design of dual valve can prevent radiotherapeutic drug from, by sacculus reflux to conduit or liquid storage warehouse, avoiding radiotherapeutic drug The damage to leak outside to human cuticular tissue.
The Arcuate puncture every thickness should on the one hand ensure its puncture resistance, on the other hand for cavity reserve part sky Between, more thin better guarantee integral thickness is subcutaneously implanted convenient for head, can be 1-4mm;
The dual valve material can be silica gel, flexibel polyurethane, hot engineering elastomer or other elastomeric macromolecule materials Material, valve are closed under without infusion or pumpback mode of operation, and liquid in conduit or sacculus is prevented to backflow, being infused or When pumpback operates, valve is in folding condition.
The length of the connecting conduit is 10cm-80cm, to be suitable for different position(In cranial cavity, in pericardium, blood vessel It is interior, it is intraperitoneal, in alimentary canal or subcutaneous)Treatment.
The positive effect of the present invention is as follows:
The dual valve of the implantable drug delivery system without infusion or pumpback operate when close, infused or pumpback behaviour When making, valve is in folding condition, have effects that it is dual it is anti-backflow, adopted suitable for artery administration, injection contrast agent, vein Blood, anticancer radiotherapy and chemotherapy medicine are administered either systemically or locally, infection, plugging, thrombus or putting of reduction caused by can effectively prevent adverse current Treat damage of the drug to patient.
Description of the drawings
Fig. 1 is the whole sectional view of the present invention
Fig. 2 is rear end of conduit sectional view
Fig. 3 is rear end of conduit valve-open and closed mode schematic diagram
Fig. 4 is catheter proximal end valve-open and closed mode schematic diagram
Fig. 5 is band sacculus drug delivery implant system schematic
Fig. 6 is valve schematic diagram in front end of different shapes
Fig. 7 is valve schematic diagram in rear end of different shapes
Fig. 8 is sacculus schematic diagram of different shapes
Reference sign:
1:Injection seat
2:Conduit
3:Sacculus
4:Arcuate puncture every
5:Gasket
6:Cavity
7:Front end
71:Front end valve
8:Rear end
81:Diaphragm
82:Rear end valve.
Specific embodiment
Embodiment 1
A kind of dual valve implantable drug delivery system as shown in Figs 1-4, is mainly used for tissue and intravascular input drug.It is wrapped Injection seat 1, connecting conduit 2 are included, 1 one side opening of injection seat is connected with the openend 8 of conduit 2, and the top of injection seat 1 has arc to wear Thorn is resistant to the multiple puncture of syringe needle, internal cavities 6 are communicated with catheter lumen, and drug enters conduit, 6 bottom of cavity by cavity every 4 There is gasket 5 in portion, and material uses pure titanium, pedestal is penetrated to limit syringe needle.
Invent the dual valve that is provided respectively positioned at the openend of conduit and blind end side wall, openend it is fixed one Diaphragm membrane structure has a notch consistent with 2 extending direction of conduit apart from the position of catheter lock port side wall, forms a polyphyll Membrane structure 7, valve 7 can be communicated when opening by tube wall with 2 inner cavity of conduit.The diaphragm and the material of conduit are silicon Glue.
The system is applicable to tissue and intravascular input chemotherapeutics, when being operated without infusion or pumpback, valve Film is closed;When being infused or pumpback operates, valve is in folding condition, and the design of dual valve can effectively be prevented The only reflux of drug and blood.
Embodiment 2
Second design that this patent is specifically related to is applied in local chemotherapy, as shown in figure 5, can be outer in the front end of connecting conduit Sacculus is closed in encryption, and the material of sacculus is nylon, for storing radiotherapeutic drug, realizes the local treatment to tumour.Practical operation Cheng Zhong after drug is injected, often with 2 tube chamber of 1 inner cavity of normal saline flushing injection seat and conduit, makes drug pass through dual valve Pressure is controlled completely into sacculus.The design of dual valve can prevent radiotherapeutic drug by sacculus reflux to conduit or liquid storage warehouse, Avoid damage of the radiotherapeutic drug leakage to human cuticular tissue.
Embodiment 3
As shown in fig. 6, catheter proximal end set a valve, valve shape can be " one " type, " two " type, " three " type, rear end of conduit Opening.
Table 1
Front end valve shape - =
Embodiment 4
As shown in fig. 7, catheter proximal end opening, rear end sets a valve, and valve shape can be " one " type, " ten " type, " two " type, " three " type, " " type, " ÷ " type.
Table 2
Rear end valve shape - + = · ÷
Embodiment 5
There is valve in the front and back end of conduit, and the valve shape of Examples 1 and 2 is subject to random combine, you can obtains the present invention's The various situations of embodiment 3.
Table 3
Embodiment 6
On the basis of embodiment 1,2,3, a closure sacculus is socketed in the front end of conduit, balloon features can be spherical, cylinder Shape, such as elliposoidal, Fig. 8.
Embodiment 7
The catheter length can be 10cm- 80cm;Different treatment positions are applicable to, intravascular in pericardium in cranial cavity, abdomen Intracavitary, in alimentary canal or subcutaneous.
Specific embodiments of the present invention have been described above, it will be appreciated by those of skill in the art that this is only to illustrate Illustrate, protection scope of the present invention is defined by the appended claims.Those skilled in the art is without departing substantially from the present invention Principle and essence under the premise of, numerous variations or change can be made to these embodiments, but these change and modification fall Enter protection scope of the present invention.

Claims (9)

1. a kind of dual valve implantable drug delivery system, which is characterized in that the implantable drug delivery system body is by injection seat 1 It is formed with connecting conduit 2, injection seat is hollow structure, as liquid storage warehouse, and passes through diaphragm and is connected with conduit;Described is double Polyphyll film implantable drug delivery system has dual valve structure, and the front end that front end valve is located at conduit is leaned near head end, rear end valve Film is located at liquid storage warehouse and catheter connector position, and passes through a diaphragm with notch and be connected, the notch shape on diaphragm Into valve structure;Second design that this patent is specifically related to is applied in local chemotherapy, can be additional in the front end of connecting conduit Closed sacculus, it is dual to prevent reflux valve for storing radiotherapeutic drug, it is possible to reduce radiopharmaceuticals reflux is more concentrated on ball Capsule realizes the local treatment to tumour;Radiotherapy isotope drug reflux is reduced to containing liquid chamber, causes local tissue damage.
2. a kind of dual valve implantable drug delivery system as described in claim 1, which is characterized in that the diaphragm and lead The material of pipe is silica gel, flexibel polyurethane, hot engineering elastomer or other high resiliency macromolecules.
3. a kind of dual valve implantable drug delivery system as described in claim 1, which is characterized in that described to be arranged at diaphragm On valve, shape can be " one " type, " ten " type, " two " type, " three " type, " " type, " ÷ " type or other can realize and prevent Liquid backflows the shape of function.
A kind of 4. dual valve implantable drug delivery system as described in claim 1, which is characterized in that the valve of the conduit head end Film shape can be " one " type, " two " type, " three " type.
A kind of 5. dual valve implantable drug delivery system as described in claim 1, which is characterized in that the thickness punctured every 4 Degree is in 1-4mm.
6. a kind of dual valve implantable drug delivery system as described in claim 1, which is characterized in that 5 material of gasket is not It is limited to metal or rigid plastics that pure titanium, titanium alloy, stainless steel, polysulfones etc. can stop sharp pin puncture.
7. a kind of dual valve implantable drug delivery system as described in claim 1, which is characterized in that catheter proximal end can connect one A closed sacculus, for storing drug, material can be silica gel, thermoelastic, polyurethane, nylon(Polyamide, PA)Or Other high molecular materials.
8. a kind of dual valve implantable drug delivery system as described in claim 1, which is characterized in that the sacculus is spherical shape, Cylinder, elliposoidal or other suitable shapes.
9. a kind of dual valve implantable drug delivery system as described in claim 1, which is characterized in that 2 length of conduit is 10cm-80cm, to be suitable for different position(It is intravascular in pericardium in cranial cavity, it is intraperitoneal, in alimentary canal or subcutaneous) Treatment.
CN201810069977.7A 2018-01-24 2018-01-24 A kind of dual valve implantable drug delivery system Pending CN108042899A (en)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111659020A (en) * 2020-06-11 2020-09-15 福建医科大学附属第一医院 Diagnostic device for brain glioma
CN112569457A (en) * 2020-12-10 2021-03-30 北京大学第三医院(北京大学第三临床医学院) Continuous drug delivery bag tube system
CN114432536A (en) * 2022-01-29 2022-05-06 深圳道远医疗科技有限公司 Integrated device and method for dynamic blood glucose monitoring and insulin injection fusion
CN115554518A (en) * 2022-10-28 2023-01-03 中国人民解放军空军军医大学 Subcutaneous administration device for preoperative chemotherapy

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN2147003Y (en) * 1992-08-27 1993-11-24 中国人民解放军第四军医大学第一附属医院 Radioactive therapeutic bag for brain colloidal tumour
CN2248569Y (en) * 1996-04-16 1997-03-05 粟祜 Device for introducing media into the body by inserting skin of anti-back-flow type
US5653683A (en) * 1995-02-28 1997-08-05 D'andrea; Mark A. Intracavitary catheter for use in therapeutic radiation procedures
CN2610936Y (en) * 2002-11-07 2004-04-14 北京航天卡迪技术开发研究所 Easy to be inserted, dropping-off prevention and anti-back flowing type catheter for giving medicine
CN200998518Y (en) * 2006-11-03 2008-01-02 刘爱军 Micro-wound implanting type radiotherapy bursa
CN104368059A (en) * 2014-11-18 2015-02-25 肖程午 Minimally invasive intervention implantable drug-supplying device with one-way valve
CN106215276A (en) * 2016-08-31 2016-12-14 北京兆仕医疗器械有限责任公司 A kind of subarachnoid space epidural canalis spinalis doser

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN2147003Y (en) * 1992-08-27 1993-11-24 中国人民解放军第四军医大学第一附属医院 Radioactive therapeutic bag for brain colloidal tumour
US5653683A (en) * 1995-02-28 1997-08-05 D'andrea; Mark A. Intracavitary catheter for use in therapeutic radiation procedures
CN2248569Y (en) * 1996-04-16 1997-03-05 粟祜 Device for introducing media into the body by inserting skin of anti-back-flow type
CN2610936Y (en) * 2002-11-07 2004-04-14 北京航天卡迪技术开发研究所 Easy to be inserted, dropping-off prevention and anti-back flowing type catheter for giving medicine
CN200998518Y (en) * 2006-11-03 2008-01-02 刘爱军 Micro-wound implanting type radiotherapy bursa
CN104368059A (en) * 2014-11-18 2015-02-25 肖程午 Minimally invasive intervention implantable drug-supplying device with one-way valve
CN106215276A (en) * 2016-08-31 2016-12-14 北京兆仕医疗器械有限责任公司 A kind of subarachnoid space epidural canalis spinalis doser

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111659020A (en) * 2020-06-11 2020-09-15 福建医科大学附属第一医院 Diagnostic device for brain glioma
CN112569457A (en) * 2020-12-10 2021-03-30 北京大学第三医院(北京大学第三临床医学院) Continuous drug delivery bag tube system
CN112569457B (en) * 2020-12-10 2024-02-13 北京大学第三医院(北京大学第三临床医学院) Continuous administration cyst tube system
CN114432536A (en) * 2022-01-29 2022-05-06 深圳道远医疗科技有限公司 Integrated device and method for dynamic blood glucose monitoring and insulin injection fusion
CN115554518A (en) * 2022-10-28 2023-01-03 中国人民解放军空军军医大学 Subcutaneous administration device for preoperative chemotherapy
CN115554518B (en) * 2022-10-28 2024-05-31 中国人民解放军空军军医大学 Subcutaneous drug delivery device for preoperative chemotherapy

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