WO2002076533A1 - Dispositif de perfusion de medicament implantable sous la peau, actionne par magnetisme - Google Patents
Dispositif de perfusion de medicament implantable sous la peau, actionne par magnetisme Download PDFInfo
- Publication number
- WO2002076533A1 WO2002076533A1 PCT/IT2001/000153 IT0100153W WO02076533A1 WO 2002076533 A1 WO2002076533 A1 WO 2002076533A1 IT 0100153 W IT0100153 W IT 0100153W WO 02076533 A1 WO02076533 A1 WO 02076533A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- drug
- patient
- tank
- infusion
- port
- Prior art date
- 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.)
- Ceased
Links
Classifications
-
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M5/14276—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/35—Communication
- A61M2205/3507—Communication with implanted devices, e.g. external control
- A61M2205/3515—Communication with implanted devices, e.g. external control using magnetic means
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/35—Communication
- A61M2205/3507—Communication with implanted devices, e.g. external control
- A61M2205/353—Communication with implanted devices, e.g. external control using mechanical means, e.g. subcutaneous pushbuttons
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
-
- 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0208—Subcutaneous access sites for injecting or removing fluids
Definitions
- the present invention relates to a subcutaneously implanted and magnetically controlled device for the infusion of drugs. More specifically, the present invention relates to a device for the infusion of drugs and/or analgesics for containing pain symptoms in patients suffering from cancer or chronic pain.
- an effective therapy for treating patients suffering from intractable chronic pain of malignant aetiology consists of the intrathecal and epidural administration of morphine or its derivatives or of synthetic opioids .
- the same therapy has also been successfully employed for treating intractable chronic pain of a non malignant nature, for instance consequent to lumbar arachnoiditis, vertebral collapse due to osteoporosis, reflex-symphathetic dystrophy, multiple sclerosis, rheumatoid arthritis and post-herpetic neuralgia.
- the intraspinal infusion of opioids exercises a strong analgesic effect through the spinal and supraspinal receptors without significantly influencing motor, sensorial and sympathetic reflexes.
- a device for the infusion of a drug into a bodily site comprises a tank for the drug, a catheter to carry the drug into the required site, for instance the intrathecal region of the spine in the case of a pain suppressing drug, and a source of mechanical energy to transfer the drug from the tank to the infusion site through the catheter.
- the device is usually implanted surgically in a subcutaneous abdominal region and there are provisions for a possibility of accessing the device at least for refilling or emptying the tank.
- the tank is of the bellows type and/or made of elastic material and is housed in a sealed chamber containing a gas, for instance freon, which is pressurised when the tank is refilled.
- a gas for instance freon
- the electronic devices comprise a tank for the drug, a peristaltic pump for extracting the drug from the tank and a catheter for transporting the pumped drug into the infusion site.
- Devices of this kind further comprise a battery for operating the pump and an electronic unit for controlling the delivery rate of the pump.
- Some known devices further comprise an antenna through which they can be programmed by an external control system, for instance a computer.
- the need to vary the hourly quantity of drug administered within ranges that can even be wide is deeply felt in numerous therapeutic treatments and also in the case of pain therapy.
- the device releases a quantity of drug deemed optimal by the physician (for instance 2 mg/day) .
- a dosage may not be adequate to cover the whole 24-hour period.
- the physician injects a supplementary dose, or bolus, of drug through a port implanted near the device and connected to the catheter. If an electronic infusion device has been implanted, instead, it is possible to change pump velocity externally and hence to increase drug dosage through the control computer.
- the aim of the present invention is to provide a device for the infusion of drugs with subcutaneous implantation in which the dosage of the administered drug can be maintained constant over 24 hours and can also be increased in a manner controlled directly by the patient for time intervals of predetermined duration, with no risk of overdose .
- Another object of the present invention is to provide a device for the infusion of drugs of the aforementioned type in which the administration of the drug can be temporarily interrupted by the physician without having to provide interruption devices operated through computerised systems .
- a further object of the present invention is to provide a device for the infusion of drugs of the aforementioned type which can be made available at lower costs that those of known similar devices.
- Yet another object of the present invention is to provide a device for the infusion of drugs in the intrathecal region of the spine of the aforementioned type, which further allows periodically to draw liquor through it .
- An additional object of the present invention is to provide a device for the infusion of drugs which can be rapidly and completely emptied if the concentration of the drug, or the drug itself, is to be changed.
- Another object of the present invention is to provide a method for the infusion of a drug that allows the patient directly to control the infusion of a bolus of drug when he/she feels the need for it, without thereby running the risk of dangerous drug overdoses .
- Figure 1 schematically shows the device of the invention and the block diagram of the related electronic control circuit
- Figure 2 is a section view of a switch of the device
- Figures 3a, 3b and 3c show the operative flowchart of the device of the invention. Description of a Preferred Embodiment
- the reference number 1 indicates a tank for the drug to be administered, bi- directionally connected to a port 2 for refilling the drug
- the reference number 3 indicates a preferably peristaltic pump operated by a direct current or stepped motor, not shown herein, and connected to the tank 1 through a conduit 4.
- the pump can be operated to provide a variable flow rate of the drug under the control of a micro-controller unit 10, in particular a continuous basic flow rate, defined by the physician according to the patient's prevailing conditions, and a greater, peak, flow rate or bolus, to be administered under particular conditions.
- the reference number 5 indicates a capillary catheter through which the drug is pumped by the peristaltic pump to the site of infusion into the patient's body, generically indicated as B.
- An on-off bi- stable valve 6 is installed on the catheter 5 immediately downstream of pump 3 to interrupt communication between the pump and the infusion site, as required in certain operating modes of the device, described farther on. Downstream of valve 6 can be installed, on catheter 5, a drawing port 7 whose function shall be described farther on.
- the aforesaid components of the device are all conventional and available on the market and thus will not be described in any greater detail, as their structure is obvious to a person skilled in the art. They are destined to be implanted, generally, into the patient's abdomen in subcutaneous position and ports 2 and 7, also implanted subcutaneously, comprise a septum that can be punctured with an Uber hypodermic needle to access tank 1 or, respectively, catheter 5.
- the components of the device can be enclosed in compact form in a single implantable case, or the drug tank can be kept separate, so that, depending on requirements, it is possible to choose among different volumes of the tank to be implanted.
- a battery 8 connected in PS1 to micro-controller 10, which through the output OUTl drives a power control unit 15 to be able to vary the velocity of the motor of pump 3 as requirements demand.
- a switch 11 is provided, connected in IN2 to micro-controller 10 and able to be operated by means of a magnet 12 which the patient approaches to skin S in correspondence with the switch from outside his/her body.
- micro-controller 10 controls a bi-stable actuator 16 associated with valve 6 to command it to open and close.
- the system is activated and deactivated through a switch 9 connected to micro-controller 10 through the input INI.
- switch 9 allows the physician to activate and deactivate the system through a simple injection of a predetermined quantity of twice- distilled water or other inert sterile liquid into the patient's abdomen through a port 17 implanted therein and conventionally provided with a septum that can be punctured with a hypodermic Uber needle.
- Port 17 is connected to a cylinder 21 in which is able to slide in sealed fashion a piston 22 that subdivides the cylinder into two chambers 21a and 21b.
- Chamber 21a communicates with the exterior through port 17, whilst in chamber 21b are located electrical contacts 23a, integral with piston 22 and 23b connected to input INI of micro-controller 10 and supported by a plug 24 that closes chamber 21b.
- An acoustic indicator device 13 is connected in OUT3 to the micro-controller to emit sound signals audible from the exterior under different circumstances, as shall be described farther on.
- the motor of pump 3 is controlled in such a way as to provide at least two different flow rates, control over flow rates being preferably achieved with PWM techniques, easily controllable in digital fashion and free of power losses and hence energy losses of the battery, as would be the case if the motor were driven in analogic fashion.
- the device for the infusion of drugs according to the present invention shall now be described with reference to Figures 3a, 3b and 3c.
- the device is programmed setting the two operating rates, a slow and a fast one, of pump 3 and then the physician fills tank 1 by injecting the drug into it through port 2.
- the device is then activated acting on switch 9.
- the control circuit verifies that valve 6 is open and activates the slow operating rate of the pump which, at this point, is implanted in the patient's abdomen. If no circumstances arise that would require a change in the operating rate of the pump, (for instance, an increase in the level of pain) the device continues to administer the drug until the content of the tank drops below a pre-set value (for instance 10 cc) .
- a pre-set value for instance 10 cc
- the timer of the control system is set in such a way that, when this condition is reached, sound indicator 13 is activated and emits an acoustic signal, for instance consisting of a number of beeps corresponding to the number of cc ' s of drug remaining in the tank every 6 hours, or another mode such as to provide an indication of the residual content of the tank.
- an acoustic signal for instance consisting of a number of beeps corresponding to the number of cc ' s of drug remaining in the tank every 6 hours, or another mode such as to provide an indication of the residual content of the tank.
- the patient has enough time to see his/her doctor who will provide for refilling the tank. If the drug in the tank is exhausted altogether, valve 6 is shut, pump 3 is turned off and the bolus administration function is disabled so that, if a bolus is required under such conditions, an acoustic signal is emitted that indicates the impossibility of administering it.
- switch 9 If switch 9 is open, all alarms are also disabled and the device is completely inoperative. If the need arises to shift to the fast operating rate of the pump to administer a drug bolus, the patient approaches magnet 12 to switch 11.
- the control systems verifies that within a pre-set previous time interval, for instance six hours, another bolus has not been administered already and that there is a pre-set volume (for instance, no less than 1 cc) of drug in the tank.
- the control system enables the activation of the fast operating rate of the pump through a timer that measures the duration of the administration of the bolus to compare it with a predetermined duration, emitting a conventional confirmation acoustic signal. If not, the control system acoustically advises the patient, for example by emitting, in the first case, a sequence of three sound signals lasting two seconds each and, in the second case, a sequence of three sound signals lasting one second each. After this administration duration is reached, the slow operating rate of the pump is resumed and the fast operation option is disabled for a predetermined minimum time interval, for instance six hours .
- the device continues with the slow administration of the drug after updating the residual quantity of drug in the tank, i.e. the variable indicated as "drug time” .
- switch 9 is opened instead, for instance when the drug has to be replaced with a different one or with the same one, but at a different concentration, or when liquor needs to be drawn from the infusion site, as shall be described farther on, valve 6 is shut, pump 3 is stopped and the drug bolus administration function is disabled, along with the alarms connected thereto.
- the "drug time" variable is automatically reset to the volume corresponding to the usable volume of the tank, so that the physician will have to fill the tank every time the device is deactivated.
- valve 6 When switch 9 is closed again, valve 6 is open, the low-rate administration of the drug is restored and the bolus administration function is enabled again, along with the alarms connected thereto, storing in the memory the time elapsed since the last administration of the bolus. Lastly, the content of the tank is reset, i.e. the "drug time" variable is updated, as stated above.
- a typical capacity value for tank 1 is 50 cc .
- the control system computes the residual content of tank 1 based on the volume of drug administered by pump 3, both in the slow and in the fast operating condition.
- the device according to the invention can also comprise the additional drawing port 7 installed on capillary catheter 5 for diagnostic interventions. Downstream of drawing port 7 is provided a valve 18 with related bi-stable on-off actuator 19 connected to an output OUT4 of micro-controller 10.
- Port 7 can be used for drawing liquor for diagnostic purposes and it also allows immediately to fill the catheter downstream of the system when replacing the drug. In case of extreme need, for instance a system failure, port 7 can be used as an emergency access for the immediate infusion of the drug.
- pump 3 is stopped and valve 6 is shut.
- Valve 18 instead remains open for a sufficient period of time to allow the drawing operation, whereupon it also shuts. It is important for the deactivation of the system also to entail the closure, albeit delayed, of valve 18, in order to prevent, when refilling the tank, the accidental use of port 7 instead of port 2 with severe injury to the patient. From the above description it is clear that the device according to the invention achieves all its set aims.
- the device allows the continuous infusion of the drug both at a pre-set dose and upon the patient's request, at a greater dose (bolus) for a predetermined time and at time intervals no shorter than a given value.
- the possibility of varying the dosage is entrusted directly to the patient by means of a simple command from the exterior with no need for the physician's intervention.
- the risk of overdose for increased dosages administered at shortened time intervals is excluded because, after each administration of a bolus, this function is disabled for a predetermined time.
- the activation and deactivation of the device is achieved with a much more economical system than the one provided in the electronic devices for the infusion of drugs currently available in the market.
- a system of acoustic alarms allows the patient to monitor the operating conditions of the device and alerts him/her when servicing is required, for instance refilling the tank.
- the device for the infusion of drugs with subcutaneous implantation can be subject to variations and/or modifications, without thereby departing from the scope of the invention as defined in the appended claims.
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- Health & Medical Sciences (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/IT2001/000153 WO2002076533A1 (fr) | 2001-03-27 | 2001-03-27 | Dispositif de perfusion de medicament implantable sous la peau, actionne par magnetisme |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/IT2001/000153 WO2002076533A1 (fr) | 2001-03-27 | 2001-03-27 | Dispositif de perfusion de medicament implantable sous la peau, actionne par magnetisme |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2002076533A1 true WO2002076533A1 (fr) | 2002-10-03 |
Family
ID=11133641
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/IT2001/000153 Ceased WO2002076533A1 (fr) | 2001-03-27 | 2001-03-27 | Dispositif de perfusion de medicament implantable sous la peau, actionne par magnetisme |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2002076533A1 (fr) |
Cited By (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1935442A2 (fr) | 2003-10-06 | 2008-06-25 | Activeo, LLC | Appareil implantable et procédé pour administrer un agent thérapeutique |
| US8066695B2 (en) | 2003-10-06 | 2011-11-29 | Ceramatec, Inc. | Implantable apparatus for administering a therapeutic agent into tissue |
| US8066659B2 (en) | 2004-06-15 | 2011-11-29 | Ceramatec, Inc. | Apparatus and method for treating and dispensing a material into tissue |
| US8353906B2 (en) | 2005-08-01 | 2013-01-15 | Ceramatec, Inc. | Electrochemical probe and method for in situ treatment of a tissue |
| CN103096966A (zh) * | 2009-10-19 | 2013-05-08 | 药物代谢动力公司 | 利用移植的磁通路泵(mbp)治疗软脑膜癌症的节拍式对流增强的鞘内化疗供给 |
| US8777889B2 (en) | 2004-06-15 | 2014-07-15 | Ceramatec, Inc. | Apparatus and method for administering a therapeutic agent into tissue |
| US9008761B2 (en) | 2010-02-01 | 2015-04-14 | Proteus Digital Health, Inc. | Two-wrist data gathering system |
| US9014779B2 (en) | 2010-02-01 | 2015-04-21 | Proteus Digital Health, Inc. | Data gathering system |
| US9084566B2 (en) | 2006-07-07 | 2015-07-21 | Proteus Digital Health, Inc. | Smart parenteral administration system |
| US9125979B2 (en) | 2007-10-25 | 2015-09-08 | Proteus Digital Health, Inc. | Fluid transfer port information system |
| CN112827009A (zh) * | 2021-02-20 | 2021-05-25 | 山东第一医科大学附属省立医院(山东省立医院) | 埋入式胃肠造瘘营养输入港 |
| CN115089807A (zh) * | 2022-06-22 | 2022-09-23 | 上海力声特医学科技有限公司 | 一种植入式给药系统 |
| WO2023088819A1 (fr) | 2021-11-17 | 2023-05-25 | Bayer Aktiengesellschaft | Système d'alerte précoce pour patients souffrant d'hypertension |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2460677A1 (fr) * | 1979-07-13 | 1981-01-30 | Univ Minnesota | Systeme de perfusion a commande magnetique pour l'administration d'un medicament |
| US4457752A (en) * | 1982-09-13 | 1984-07-03 | Csaba Vadasz | Surgically implantable pump |
| US4541429A (en) * | 1982-05-10 | 1985-09-17 | Prosl Frank R | Implantable magnetically-actuated valve |
| US4673391A (en) * | 1983-05-31 | 1987-06-16 | Koichi Sakurai | Non-contact controlled micropump |
| US4692147A (en) * | 1980-04-02 | 1987-09-08 | Medtronic, Inc. | Drug administration device |
| US4747832A (en) * | 1983-09-02 | 1988-05-31 | Jacques Buffet | Device for the injection of fluid, suitable for implantation |
-
2001
- 2001-03-27 WO PCT/IT2001/000153 patent/WO2002076533A1/fr not_active Ceased
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2460677A1 (fr) * | 1979-07-13 | 1981-01-30 | Univ Minnesota | Systeme de perfusion a commande magnetique pour l'administration d'un medicament |
| US4692147A (en) * | 1980-04-02 | 1987-09-08 | Medtronic, Inc. | Drug administration device |
| US4541429A (en) * | 1982-05-10 | 1985-09-17 | Prosl Frank R | Implantable magnetically-actuated valve |
| US4457752A (en) * | 1982-09-13 | 1984-07-03 | Csaba Vadasz | Surgically implantable pump |
| US4673391A (en) * | 1983-05-31 | 1987-06-16 | Koichi Sakurai | Non-contact controlled micropump |
| US4747832A (en) * | 1983-09-02 | 1988-05-31 | Jacques Buffet | Device for the injection of fluid, suitable for implantation |
Cited By (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8162873B2 (en) | 2003-10-06 | 2012-04-24 | Ceramatec, Inc. | Apparatus for administering a therapeutic agent into tissue |
| EP1935442A3 (fr) * | 2003-10-06 | 2008-07-02 | Activeo, LLC | Appareil implantable et procédé pour administrer un agent thérapeutique |
| US8066695B2 (en) | 2003-10-06 | 2011-11-29 | Ceramatec, Inc. | Implantable apparatus for administering a therapeutic agent into tissue |
| EP1935442A2 (fr) | 2003-10-06 | 2008-06-25 | Activeo, LLC | Appareil implantable et procédé pour administrer un agent thérapeutique |
| US8777889B2 (en) | 2004-06-15 | 2014-07-15 | Ceramatec, Inc. | Apparatus and method for administering a therapeutic agent into tissue |
| US8591472B2 (en) | 2004-06-15 | 2013-11-26 | Ceramatec, Inc. | Apparatus for administering a therapeutic agent into tissue using a needle as the material treatment module |
| US8066659B2 (en) | 2004-06-15 | 2011-11-29 | Ceramatec, Inc. | Apparatus and method for treating and dispensing a material into tissue |
| US8986520B2 (en) | 2004-06-15 | 2015-03-24 | Ceramatec, Inc. | Apparatus administering a therapeutic agent into tissue |
| US8353906B2 (en) | 2005-08-01 | 2013-01-15 | Ceramatec, Inc. | Electrochemical probe and method for in situ treatment of a tissue |
| US9084566B2 (en) | 2006-07-07 | 2015-07-21 | Proteus Digital Health, Inc. | Smart parenteral administration system |
| US9125979B2 (en) | 2007-10-25 | 2015-09-08 | Proteus Digital Health, Inc. | Fluid transfer port information system |
| CN103096966A (zh) * | 2009-10-19 | 2013-05-08 | 药物代谢动力公司 | 利用移植的磁通路泵(mbp)治疗软脑膜癌症的节拍式对流增强的鞘内化疗供给 |
| US9014779B2 (en) | 2010-02-01 | 2015-04-21 | Proteus Digital Health, Inc. | Data gathering system |
| US9008761B2 (en) | 2010-02-01 | 2015-04-14 | Proteus Digital Health, Inc. | Two-wrist data gathering system |
| US10376218B2 (en) | 2010-02-01 | 2019-08-13 | Proteus Digital Health, Inc. | Data gathering system |
| CN112827009A (zh) * | 2021-02-20 | 2021-05-25 | 山东第一医科大学附属省立医院(山东省立医院) | 埋入式胃肠造瘘营养输入港 |
| WO2023088819A1 (fr) | 2021-11-17 | 2023-05-25 | Bayer Aktiengesellschaft | Système d'alerte précoce pour patients souffrant d'hypertension |
| CN115089807A (zh) * | 2022-06-22 | 2022-09-23 | 上海力声特医学科技有限公司 | 一种植入式给药系统 |
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