EP1397084A1 - Controle de la frequence d'utilisation de produits electromedicaux - Google Patents

Controle de la frequence d'utilisation de produits electromedicaux

Info

Publication number
EP1397084A1
EP1397084A1 EP02747324A EP02747324A EP1397084A1 EP 1397084 A1 EP1397084 A1 EP 1397084A1 EP 02747324 A EP02747324 A EP 02747324A EP 02747324 A EP02747324 A EP 02747324A EP 1397084 A1 EP1397084 A1 EP 1397084A1
Authority
EP
European Patent Office
Prior art keywords
probe
generator
medical device
resistance
reuse
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.)
Withdrawn
Application number
EP02747324A
Other languages
German (de)
English (en)
Inventor
Kai Desinger
Markus Fay
Thomas Stein
Thomas Fricke
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Celon AG Medical Instruments
Original Assignee
Celon AG Medical Instruments
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 Celon AG Medical Instruments filed Critical Celon AG Medical Instruments
Publication of EP1397084A1 publication Critical patent/EP1397084A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00172—Connectors and adapters therefor
    • A61B2018/00178—Electrical connectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/0066—Sensing and controlling the application of energy without feedback, i.e. open loop control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00988—Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter

Definitions

  • the invention relates to an electrically operated medical product which is to be put into electrical operation by switching on or connecting to an electrical energy source.
  • the invention relates to ensuring the frequency of use of active medical products or inactive medical products in connection with an active medical product, ie a frequency of use of its medical products specified by the manufacturer is not exceeded according to the invention depending on the duration of therapy or use. In addition to compliance with guarantee or warranty claims, this ensures a constant quality for the intended life cycle of the product and thus increases user and patient safety.
  • the invention preferably relates to medical devices such as instruments, catheters or electrodes (hereinafter referred to as PROBE) for minimally invasive or invasive use in and on the patient, as well as medical implant devices. actions (e.g. cardiac pacemakers, pacemaker electrodes or stimulation electrodes in neurosurgery) that are used in connection with active, energetically operated medical devices (e.g. high-frequency generators, pacemakers, stimulation amplifiers, stimulation current devices) (hereinafter referred to as GENERATORS) on the patient for a short or long term and there energy in the form of alternating current apply.
  • GENERATORS GENERATORS
  • the surgical and sterile instruments, catheters or other medical devices declared by the manufacturer as disposable products are often used or used several times on different patients after renewed re-sterilization (e.g. gas or steam sterilization at 134 ° C) or for different patients without following the warnings in the instructions for use for the product.
  • Instruments that have been sterilized several times and which are not explicitly intended for this purpose pose a potential risk to the patient (e.g. due to material fatigue due to sterilization, parts of the instrument can remain in the patient, malfunctions, functional failure, spreading of germs / cross-contamination) as well as for the user (e.g. deteriorated insulation properties) live handle parts after re-sterilization).
  • the object of the invention is therefore to present possibilities for ensuring the frequency of use of the disposable products or products with a defined period of use.
  • the solutions mentioned here include both the active and the inactive product in their technological implementation.
  • a medical product of the type mentioned at the outset with a reuse lock which can be connected and designed in such a way that the reuse lock is initialized when the electrical start-up is started for the first time and its state is changed so that operation of the medical product is possible, as long as the medical device is connected to the energy source or the energy source is switched on and that the reuse lock prevents a restart after disconnection from the energy source.
  • the reuse block preferably comprises at least one ohmic resistor, whose resistance value is changed or destroyed when the surgical instrument is started up for the first time, and a detector which responds to a deviation of the resistance value from a predetermined value range and triggers the reuse block so that the medical device is put into operation is prevented.
  • a medical product with an electrically operated probe which is connected to a generator as an energy source with monitoring electronics, which includes the detector, is particularly preferred, the initial electrical commissioning of the probe being an initial application, characterized by a configuration of the probe and monitoring electronics such that Each initial application leads to a change in the state of the probe, which is caused by the monitoring electronics in the generator.
  • the monitoring electronics are preferably designed to switch off an output of the generator when the probe reaches a predetermined state before the initial application.
  • the monitoring electronics are preferably designed such that the probe can be used as often as desired by the user after the initial application has taken place, as long as the probe is still connected to the generator and this generator is switched on or active.
  • the reuse block preferably includes parallel-connected resistance fuses in the probe, the individual states of the probe being given by the total resistance of the parallel-connected resistance fuses and a change in state being equivalent to a change in the total resistance caused by the failure or melting of individual resistors.
  • the changes in state of the probe can be implemented by changing a magnetizable component of the probe, preferably a narrow magnetic band on the probe connector, a change in state being given by a changed direction of magnetization, and the generator comprises a detection unit which is designed to recognize and change the direction of the magnetization.
  • Figure 1 shows an application example
  • FIG. 2 shows a flowchart for a logic of a generator
  • a first, simple and inexpensive technical implementation is, according to the invention, the insertion of commercially available, parallel-connected resistance fuses (R1, R2, R3, ...) on the probe side and, on the other hand, a simple resistance detection (logic) with a built-in at the output of the generator additional, controlled voltage source, the output of which causes the resistance fuses in the probe to melt at predefined times (see FIG. 1).
  • FIG. 1 shows a schematic representation of a probe 10 with probe tip 12 for interstitial use and probe connector 14. Resistance fuses with resistors R1, R2, R3 and R4 are provided in the probe connector.
  • the probe connector is connected to a generator 20, in addition to the usual generator components such as a current source 22, which feeds generator electronics 24, which in turn are connected via an output power regulator or switch 26 is connected to contacts for an electrical connection to the probe connector, the generator 20 also has monitoring electronics 30.
  • the monitoring electronics 30 comprise a controlled voltage source 32 and a logic 34.
  • the voltage source 32 is connected via a isolating transformer 36 to the resistance fuses R1-R4 in the probe connector 14 when the probe connector 14 is connected to the generator 20.
  • the logic 34 is also connected to the voltage source 32 and also via an interface 36 to the generator electronics 24 of the generator 20.
  • An optional contact 38 which is connected to the logic 34, is used to signal the logic that a indeed Probe connector 14 is connected to the generator 20.
  • This built-in electronics is connected to the generator electronics via an interface and decides whether power should be delivered to the currently connected probe or not.
  • the frequency of use is realized according to the invention via the number and the total resistance of the resistance fuses on the probe side.
  • the frequency of the use of the probe is not counted on the basis of the individual application in the patient during a treatment, but according to the invention how many times a probe is used for different treatment appointments with an operational generator, i.e. as long as the probe connector is connected to a generator that is switched on, any number of applications can be carried out on the patient. Only the first application (hereinafter referred to as the initial application) is counted. With each initial application, a resistance fuse is destroyed and the total resistance of the resistors connected in parallel changes.
  • the electronics switch off the power output before the first application and no further treatment or use of the product is possible. This is indicated to the user, for example, by a signal lamp on the generator (see FIG. 2).
  • the probe detection at the generator output (“is the probe connected to the generator?”) Can be implemented on the one hand via the measured parallel resistance or with a switch contact 38 on the output socket, which detects the insertion position of the probe connector.
  • the operation of the device described above proceeds as follows: first the generator is switched on, then it is checked whether the probe is connected to the generator (for example via contact 38), then the parallel resistance the resistance fuses measured. In an alternative variant, a direction of magnetization is measured. If the measured value is in the permitted range, the generator output is activated. If the value is outside the permissible range, the generator output is deactivated and a signal lamp 40 is switched on. In this case, the reuse lock ensures that the probe 10 cannot be used again.
  • the generator output is activated, it is first checked whether it is an initial application. If so, one of the resistance fuses is destroyed or a magnetization direction is changed in the alternative embodiment. Then it is checked whether there is another application. If the test for the existence of an initial application is denied, the test immediately proceeds to determine whether there is another application. If this is the case, it is checked again whether the further application is an initial application. If no further application is to be carried out, the probe is disconnected from the generator.
  • the resistance fuses can be installed in both the connector part and the handle part of the probe.
  • variable 2 Another possibility for monitoring the frequency of use (variant 2) is, according to the invention, to identify each probe by providing a magnetic strip on the probe connector, the direction of magnetization of which is changed after each initial application.
  • the monitoring electronics are also located in the generator. When a certain direction of magnetization is reached, the generator output is deactivated.
  • Another solution according to the invention is the mechanical or mechanical-electrical securing of the connection between the generator and the probe, which ensures a safe, intended energy transfer when the two parts (probe and generator) are first coupled, but which is mechanically changed when the connection is subsequently disconnected, that a new coupling of the interface is either excluded mechanically, or an electrical signal prevents a renewed release of energy due to the mechanical change.
  • This information serves as a "fingerprint” for the specific environmental and application parameters of the initial area of application. If the medical device is to be operated in another area of application (eg in another patient), the medical device recognizes the changed environmental parameters and the logic for monitoring the frequency of use Operating conditions (e.g. outside the patient, high temperature during sterilization, in the "New" patients), the system is switched off and can no longer be activated.

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Plasma & Fusion (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Otolaryngology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Magnetic Resonance Imaging Apparatus (AREA)
  • Surgical Instruments (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

L'invention concerne des produits médicaux à actionnement électrique qui sont actionnés électriquement par mise sous tension d'une source d'énergie électrique ou par connexion à celle-ci. Ces produits se caractérisent par un dispositif de blocage de réutilisation qui peut être relié à la source d'énergie et qui est conçu de telle sorte que, lors de la première mise en service électrique, ce dispositif est initialisé et son état est modifié de telle sorte que le produit médical peut être actionné tant que l'instrument chirurgical est relié à la source d'énergie ou tant que la source d'énergie est sous tension. Après déconnexion de la source d'énergie, le dispositif de blocage de réutilisation empêche une nouvelle mise en service ou autorise uniquement un nombre de cycles d'utilisation spécifié par le fabricant.
EP02747324A 2001-06-01 2002-05-24 Controle de la frequence d'utilisation de produits electromedicaux Withdrawn EP1397084A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10126950A DE10126950A1 (de) 2001-06-01 2001-06-01 Sicherstellung der Gebrauchshäufigkeit von Medizinprodukten
DE10126950 2001-06-01
PCT/EP2002/005766 WO2002098311A1 (fr) 2001-06-01 2002-05-24 Controle de la frequence d'utilisation de produits electromedicaux

Publications (1)

Publication Number Publication Date
EP1397084A1 true EP1397084A1 (fr) 2004-03-17

Family

ID=7687039

Family Applications (1)

Application Number Title Priority Date Filing Date
EP02747324A Withdrawn EP1397084A1 (fr) 2001-06-01 2002-05-24 Controle de la frequence d'utilisation de produits electromedicaux

Country Status (6)

Country Link
US (1) US20050239349A9 (fr)
EP (1) EP1397084A1 (fr)
JP (1) JP2004527358A (fr)
CN (1) CN1525840A (fr)
DE (1) DE10126950A1 (fr)
WO (1) WO2002098311A1 (fr)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7176030B2 (en) * 2002-06-17 2007-02-13 O.R. Solutions, Inc. Method and apparatus for ensuring sterility of disposable medical items used with medical equipment
US20090065565A1 (en) * 2007-09-12 2009-03-12 Vascular Technologies, Inc. System, method and apparatus for preventing reuse of medical instruments
US8540709B2 (en) * 2009-12-07 2013-09-24 Covidien Lp Removable ink for surgical instrument
US8968294B2 (en) 2012-04-17 2015-03-03 Covidien Lp Single or limited use device designs
US9943359B2 (en) * 2012-04-30 2018-04-17 Covidien Lp Limited reuse ablation needles and ablation devices for use therewith
EP2986339A4 (fr) * 2013-04-19 2016-12-21 Oculeve Inc Dispositifs et procédés de stimulation nasale
US9566109B2 (en) 2013-07-18 2017-02-14 Covidien Lp Limited-use surgical devices
CN106456270B (zh) * 2014-04-09 2020-04-07 捷锐士阿希迈公司(以奥林巴斯美国外科技术名义) 医疗装置
US11452559B2 (en) 2019-06-25 2022-09-27 Covidien Lp Electrosurgical plug for energy activation of surgical instruments
US11504179B2 (en) 2019-06-25 2022-11-22 Covidien Lp Electrosurgical plug for energy activation of surgical instruments

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5573533A (en) * 1992-04-10 1996-11-12 Medtronic Cardiorhythm Method and system for radiofrequency ablation of cardiac tissue
US5400267A (en) * 1992-12-08 1995-03-21 Hemostatix Corporation Local in-device memory feature for electrically powered medical equipment
US5749871A (en) * 1993-08-23 1998-05-12 Refractec Inc. Method and apparatus for modifications of visual acuity by thermal means
US5620474A (en) * 1995-04-24 1997-04-15 Vitatron Medical, B.V. System and method for determining indicated pacemaker replacement time based upon battery impedance measurement
SE9702679D0 (sv) * 1997-07-11 1997-07-11 Siemens Elema Ab Anordning för att räkna antalet användningar av en givare
US6270460B1 (en) * 1999-06-24 2001-08-07 Acuson Corporation Apparatus and method to limit the life span of a diagnostic medical ultrasound probe

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO02098311A1 *

Also Published As

Publication number Publication date
DE10126950A1 (de) 2002-12-12
US20050239349A9 (en) 2005-10-27
WO2002098311A1 (fr) 2002-12-12
CN1525840A (zh) 2004-09-01
JP2004527358A (ja) 2004-09-09
US20040110428A1 (en) 2004-06-10

Similar Documents

Publication Publication Date Title
DE102013211859B4 (de) Magnetstimulator zur Stimulation eines Gewebes durch ein Magnetfeld
DE3510586C2 (fr)
DE102006018191B4 (de) Elektrisches Marknagelsystem
WO2009083086A2 (fr) Dispositif de contact pour l'ostéosynthèse
EP0390937B1 (fr) Dispositif pour surveiller l'adhésion des électrodes neutres utilisées en chirurgie à haute fréquence
EP2523726B1 (fr) Stimulation magnétique au moyen d'une forme d'impulsion librement sélectionnable
EP2467190B1 (fr) Dispositif de polarisation et système d'implantation
DE4339049A1 (de) Einrichtung zur Konfiguration chirurgischer Systeme
DE102004055866B4 (de) Gerät zur Zerstörung von Tumorgewebe
DE102007056974A1 (de) HF-chirurgische Prüfeinrichtung
EP3284516B1 (fr) Implant et procédé d'identification d'une ligne d'électrodes
WO2002098311A1 (fr) Controle de la frequence d'utilisation de produits electromedicaux
EP0459402A2 (fr) Appareil électro-médical produisant un champ magnétique basse fréquence
EP2700427B1 (fr) Dispositif de chauffage de fluide et procédé de fonctionnement d'un dispositif de chauffage de fluide
DE102009008698B4 (de) Elektrochirurgisches Gerät, Filteradapter zur lösbaren Verbindung mit einem elektrochirurgischen Instrument, Verfahren zur Steuerung eines elektrochirurgischen Geräts
EP0414929A1 (fr) Appareil médical utilisable au choix en mode bipolaire ou unipolaire, ayant un connecteur pour une électrode conductrice d'un signal électrique entre l'appareil et le corps d'un être vivant
EP1277493B1 (fr) Dispositif médical jetable
EP3457972B1 (fr) Instrument chirurgical, en particulier instrument d'électrochirurgie
EP3284510B1 (fr) Ligne d'electrodes, implant et procede d'identification d'une ligne d'electrodes
DE3623340C2 (fr)
DE102021106537A1 (de) Elektrochirurgisches System, elektrochirurgisches Steuergerät, elektrochirurgisches Instrument und Verfahren zum Betrieb eines elektrochirurgischen Systems
EP3284508B1 (fr) Implant et procede d'identification d'une ligne d'electrodes
EP4265211A1 (fr) Système d'électrochirurgie et procédé de détermination d'un type d'électrode d'une électrode neutre
DE10208391A1 (de) Implantat zur lokalen Stimulierung von Muskel- und Nervenzellen
DE102018112298A1 (de) Vorrichtung zur Behandlung und/oder Vermeidung von Biofilmen und/oder Infektionen an permanent bestehenden oder temporär bestehenden Hautdurchtritten

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20040102

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU MC NL PT SE TR

AX Request for extension of the european patent

Extension state: AL LT LV MK RO SI

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN

18D Application deemed to be withdrawn

Effective date: 20060707