WO2022152585A1 - Dispositif médical implantable - Google Patents

Dispositif médical implantable Download PDF

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Publication number
WO2022152585A1
WO2022152585A1 PCT/EP2022/050021 EP2022050021W WO2022152585A1 WO 2022152585 A1 WO2022152585 A1 WO 2022152585A1 EP 2022050021 W EP2022050021 W EP 2022050021W WO 2022152585 A1 WO2022152585 A1 WO 2022152585A1
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WO
WIPO (PCT)
Prior art keywords
housing
implantable medical
medical device
motion
anchoring
Prior art date
Application number
PCT/EP2022/050021
Other languages
English (en)
Inventor
R. Hollis Whittington
Andreas Becker
Dirk Muessig
Original Assignee
Biotronik Se & Co. Kg
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 Biotronik Se & Co. Kg filed Critical Biotronik Se & Co. Kg
Publication of WO2022152585A1 publication Critical patent/WO2022152585A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/375Constructional arrangements, e.g. casings
    • A61N1/37518Anchoring of the implants, e.g. fixation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37205Microstimulators, e.g. implantable through a cannula

Definitions

  • the present invention relates to an implantable medical device.
  • Medical devices which can be implanted into a chamber of a heart to deliver stimulation. These so called intracardiac pacing systems or leadless pacemakers are anchored to tissue inside the heart (myocardium).
  • myocardium tissue inside the heart
  • intracardiac pacing systems or leadless pacemakers are anchored to tissue inside the heart (myocardium).
  • After implantation in some cases it may be necessary to remove the device.
  • bodily tissue which is created around the device due to natural body reactions. As an important side effect, this physiological process leads to a more secure anchoring of the device but may impede extraction of the device.
  • a helical fixation which is a sturdy wire that is threaded into the myocardium (e.g. disclosed in US 2012/0158111 Al and US 2012/0116489 Al), and (ii) tines with a backward bend, which during implantation get stretched for piercing the myocardium (e.g. disclosed in US 2014/0121719 Al).
  • Helical fixation techniques can be implanted and explanted with a rotational movement to screw the device in or out the myocardium.
  • screwing the device into the myocardium during initial implantation is very dangerous and can lead to a myocardial perforation.
  • Another option is a tined device, which during initial implantation is more secure with lower risk of dangerous myocardial perforation compared to a device using a helix fixation.
  • a longitudinal retraction force has to be applied, which can be dangerous to the patient. Accordingly, there is still a need for reliable and compliant means for fixing a medical device, particularly an intracardiac pacing system, at the intended tissue, e.g. the myocardium.
  • an implantable medical device particularly an intracardiac pacing system that avoids the above-mentioned disadvantages of the state of the art.
  • implantable medical device is designed to facilitate the extraction of the implant, by which_the extraction of an implanted device shall be made safer for a patient and easier for a physician.
  • an implantable medical device comprises a housing and an anchoring device coupled to the housing, wherein the housing comprises a motion-converting structure which is configured to convert a rotation of the housing in a linear motion of the housing.
  • the anchoring device may be at least partially bio-degraded so that the initially intended anchoring may be terminated and the device is held in place by the encapsulation only. Extraction of the device is for example possible by applying a rotational movement. A physician does not need to apply a pulling force to explant the device. However, it is also conceivable to use an anchoring device being extractable also by rotation, e.g. when designed in form of a screw or a wire helix, in combination with above described housing having the motion-converting structure.
  • the motion-converting structure is arranged or attached on a surface of the housing.
  • the housing is designed in form of a cylinder, wherein the motion-converting structure is arranged on the lateral area of the cylinder.
  • the motion converting structure extends form a distal end of the housing to a proximal end of the housing.
  • the motion-converting structure is formed by a single motion-converting element.
  • the motion-converting structure is formed by a plurality of motion-converting elements which are separated from each other.
  • the motion-converting structure protrudes from the surface of the housing.
  • the motion-converting structure is recessed in the surface of the housing.
  • the motion-converting structure is formed by a thread or a threaded groove.
  • the motionconverting structure is designed as a thread or a thread structure on the housing.
  • Such thread or thread structure may be formed by a helical protrusion or recess running around the housing.
  • the motion-converting structure may be formed by material deposition, e.g. physical vapor deposition (PVC), chemical vapor deposition (CVC), welding, soldering, molding or overmolding.
  • PVC physical vapor deposition
  • CVC chemical vapor deposition
  • the anchoring device comprises at least one fixation element being in form of a tine, a hook or a barb.
  • the anchoring device comprises at least one fixation element being designed in form of a screw or wire helix.
  • the anchoring device is configured to provide an at least temporary fixation of the housing to tissue (e.g. myocardium).
  • tissue e.g. myocardium
  • the temporary fixation of the housing may be provided by the anchoring device comprising at least in part a biodegradable material as disclosed below.
  • the anchoring device comprises at least in part a biodegradable material, wherein, before the biodegradable material is degraded, the anchoring device provides a fixation of the housing to tissue (e.g. myocardium), and wherein, after the biodegradable material is degraded, the anchoring device does not provide a fixation of the housing to tissue anymore.
  • the anchoring device comprises at least one fixation element being designed in form a tine, a hook, a barb, or a flexible basket/umbrella-like structure, wherein the at least one fixation element is made of or comprises the biodegradable material.
  • biodegradable (or biocorrodible or bioabsorbable or bioresorbable or biodissolvable) material is used in the context of present disclosure in the meaning known to the skilled person, it particularly refers to a material that is decomposed in a human or animal body, particularly in presence of bodily fluids such as blood.
  • the anchoring device may be used for anchoring the housing of the device to tissue after implantation. After a while, the device will be at least partially be encapsulated by tissue due to biological processes. Then, the encapsulation provides fixation of the device and the anchoring device is no longer necessary. Dissolving or degrading the anchoring device in part or completely or releasing the anchoring device from the implantable medical device may facilitate or ease extraction of the device if this becomes necessary. After the anchoring device is partly or completely degraded, removal of the device may be performed by applying a longitudinal force and / or a rotational force to the device.
  • the anchoring device is arranged at a distal end of the housing.
  • a distal end of the housing (or another component) is an end which in the implanted state of the device is closer to tissue than a proximal end of the housing (or another component).
  • the anchoring device comprises a base member which is coupled to the housing, wherein the anchoring device comprises at least one fixation element which is connected to the base member.
  • the anchoring device comprises at least one fixation element which is connected to the base member.
  • four anchoring elements such as tines, hooks or barbs
  • the base member may have a circular shape.
  • the base member may be arranged at the distal end of the housing.
  • the base member may comprise the biodegradable material.
  • the at least one anchoring element may comprise the biodegradable material.
  • the at least one anchoring element may comprise a base portion, wherein the base portion is adjacent to the base member, and wherein the base portion comprises the biodegradable material.
  • the anchoring device may comprise at least two anchoring elements which are connected to the base member, wherein an intermediate portion of the base member is formed between connection regions of the at least two anchoring elements with the base member, and wherein the intermediate portion comprises the biodegradable material.
  • the base member may be attached to the housing with a connecting element or support member, wherein the connecting element or the support member comprises the biodegradable material.
  • a proximal end of the anchoring device is arranged in a recess formed at the housing, wherein the recess is at least partially filled or covered with a biodegradable filling material not permeable for body fluid.
  • the biodegradable filling material may be different from the biodegradable material of the anchoring device.
  • the proximal end of the tine(s) may be arranged in the recess (or several recesses), wherein the recess(es) is (are) filled or covered with the biodegradable material thereby temporarily blocking ingress of body fluids in the recess, where the biodegradable material of the anchoring device is situated as well.
  • the biodegradable material may be decomposed within a defined period of time, e.g. two weeks, after implantation, thereafter allowing body fluids access to the biodegradable tines, which are then in turn decomposed as well.
  • the degradation time of the biodegradable filling material may be different from the degradation time of the biodegradable material of the anchoring device.
  • the biodegradable material may be a biodegradable metal, a biodegradable metal alloy, a biodegradable polymer, or a biodegradable ceramic.
  • the biodegradable metal alloy may include magnesium, iron and/or zinc as a main alloy component or an alloy component.
  • the main alloy component is the component, whose amount by weight in the alloy is the greatest.
  • the main alloy component may amount to more than 90 % by weight, more 70 % by weight, and particularly more than 50 % by weight.
  • the main alloy component is Magnesium.
  • Suitable alloys are Magnesium Zinc Calcium alloys, which are disclosed in documents WO 2014/001321 Al and WO 2014/001241 Al, Magnesium Aluminum alloys as disclosed in document WO 2014/001240 Al, or Magnesium Aluminum Zinc alloys as disclosed in document WO 2014/001191 Al .
  • Suitable biodegradable polymers are polylactic acid (PLA), poly-L-lactide (PLLA), and poly-D-lactide (PDLA), etc.
  • the biodegradable material may be completely degraded after 3 to 12 months after degradation is initiated.
  • the biodegradable material is degraded 3 to 12 months after implantation of the device.
  • the anchoring device or at least the part of the anchoring device which comprises the biodegradable material, loses its mechanical integrity.
  • the degradation time may be adjusted to less than 12 months, less than 8 months, or to 3 to 6 months.
  • the recess may be at least partly filled or covered with a switchable material being not permeably for bodily fluids in a first state and being permeable for bodily fluids in a second state, wherein material is switchable between the first state and the second state by an external stimulus, e.g. RF energy, an magnetic field or like.
  • the switchable material may be switched after defined period of time (switch time), e.g. two weeks, after implant, thereby allowing access of bodily fluids to the biodegradable tines, which are then consequently decomposed.
  • Suitable switchable materials are disclosed, e.g. in document US 2011/0276124 Al.
  • the switch time may be chosen significantly shorter in order to immediately response to the external stimulus.
  • the switch time may be adjusted to one month or several weeks, for example 2 weeks.
  • the housing comprises a surface being configured to prevent or decrease in-growth of the housing, wherein particularly the surface is characterized by a predefined roughness.
  • an anchoring device e.g. comprising one or more a tines
  • the anchoring device then at least partially dissolves in the body after implantation, ideally once encapsulation is sufficient to anchor the device. If explantation is needed, the device can be captured, twisted to break attachment to fibrous encapsulation without damaging the heart, and then extracted with longitudinal force.
  • the implantable medical device may be an active implant, e.g. an intracardiac pacing system or a monitoring system.
  • the device may comprise at least one electrode, e.g. a pacing electrode and / or a sensing electrode.
  • the housing may enclose an electronic circuit and a battery.
  • the aspect of the biodegradable anchoring device can be combined with the aspect of the motion-converting structure of the housing in any manner. All embodiments of the biodegradable anchoring device can be combined with all embodiments of the motionconverting structure.
  • Fig. 1 A - 1C show a first embodiment of an implantable medical device with a temporary anchoring device.
  • Fig. 2A - 2C show a second embodiment of an implantable medical device with a temporary anchoring device.
  • Fig. 3 A - 3C show a third embodiment of an implantable medical device with a temporary anchoring device.
  • Fig. 4A - 4C show a fourth embodiment of an implantable medical device with a temporary anchoring device.
  • Fig. 5 shows an embodiment of an implantable medical device with a temporary anchoring device and a motion-converting structure.
  • Figs. 1A to 1C show an implantable medical device 5 that comprises a housing 4, an anchoring device 1, and a support member 3.
  • the implantable medical device 5 is an implantable cardiac pacemaker, particularly an intra-cardiac pacing system (IPS).
  • IPS intra-cardiac pacing system
  • Such an IPS is configured to be implanted into a ventricle and/or an atrium of the patient’s heart, particularly into the left ventricle and/or left atrium, right ventricle and/or right atrium or other combinations, particularly via a catheter.
  • a device may be fixated to the epicardial surface of the heart.
  • the implantable medical device 5 particularly comprises a hermetically sealed housing 4.
  • the housing 4 particularly encloses a pulse generator for generating pacing pulses that are to be applied to the patient’s heart via at least one pacing electrode on or at the housing, sensing circuits for sensing physiological signals from the body of the patient, and a battery for supplying energy to the pulse generator and / or to the sensing circuits.
  • a pulse generator for generating pacing pulses that are to be applied to the patient’s heart via at least one pacing electrode on or at the housing, sensing circuits for sensing physiological signals from the body of the patient, and a battery for supplying energy to the pulse generator and / or to the sensing circuits.
  • the anchoring device 1 comprises at least one tine 20. Here, four tines 20 are shown, but other numbers of tines are possible.
  • the anchoring device 1 is used to anchor the housing 4 of the implantable medical device 5 to bodily tissue, e.g. myocardium. With the support member 3, the anchoring device 1 is at least temporary mounted to the housing 4 of the implantable medical device 5.
  • the anchoring device 1 is mounted in or at the implantable medical device 5 such that the tines 20 protrude out of or away from the housing 4 for anchoring the implantable medical device 5 to tissue of a bodily cavity.
  • At least a part of the anchoring device 1 is preferably made of a biodegradable metal, a biodegradable metal alloy or a biodegradable polymer.
  • the anchoring device 1 is partially or completely biodegradable in vivo.
  • the complete anchoring device 1, or at least the parts of the anchoring device 1, which comprises the biodegradable material loses its mechanical integrity. The specific time depends on the material composition of the material used for forming the anchoring device 1 or its components. The degradation products are mainly resorbed by the body, although small residues are in general tolerable.
  • the anchoring device 1 may be designed in form of a screw or wire helix, which may be made of a biodegradable material or a biostable, biocompatible material, such as, e.g. nitinol.
  • the at least one tine 20 may be a single tine or may alternatively be implemented as a tine array comprising an annular ring 10 (see Figs. 2 - 4) and a plurality of elongated tines 20 connected to the annular ring 10 and protruding from the annular ring 10.
  • An example, which is incorporated by reference, is shown in US provisional patent application No. 62/516,869.
  • the support member 3 can be a polymer ring or a ceramic ring, which is cast-molded around the anchoring device 1 and a part of the housing 4 or glued or otherwise adhered to anchoring device 1 and housing 4.
  • the support member 3 can be part of the housing 4, for example in form of a groove, notches, indentations and the like.
  • the tines 20 or the tine array are preferably made of a biodegradable material, for example a biodegradable metal or metal alloy as specified above.
  • a biodegradable material for example a biodegradable metal or metal alloy as specified above.
  • the tines 20 or the tine array start to degrade and to lose their mechanical integrity by a graduate biodegradation. This progressive degradation is exemplary shown in Fig. IB.
  • the tines 20 or the tine array are completely disappeared (Fig. 1C) and the device 5 is anchored by tissue only (the tissue is not shown).
  • the tines 20 or the tine array may be made of a biostable, biocompatible material, e.g. nitinol.
  • Figs. 2A - 2C and 3A - 3C show two exemplary alternatives of the anchoring device 1 for temporarily anchoring the device 5 to tissue of a patient.
  • the anchoring device 1’, 1 which is also denoted as tine array, comprises an annular ring 10’, 10” and a plurality of elongated tines 20’, 20” connected to the annular ring 10’, 10” and protruding from the annular ring 10’, 10”.
  • the annular ring 10’, 10” and the tines 20’, 20” are formed out of a superelastic alloy comprising nickel and titanium, particularly Nitinol.
  • the annual ring 10’, 10” is attached to an end of the housing 4 and secured by the support member 3 (see Fig. 1 A).
  • each of the tines 20’ has a portion 100’ consisting of a biodegradable material as mentioned before, preferably a biodegradable metal or a biodegradable metal alloy.
  • Each portion 100’ is situated at the base of each tine 20’, where each tine 20’ is connected to the annular ring 10’. Other positions are possible.
  • the portion 100’ is completely degraded and parts of the tines 20’, preferably the tips protruding from the housing 4, are separated from the annular ring 10’ (see Fig. 2B). At this time the device 5 is anchored by the ingrowth only.
  • the annular ring 10 has portions 100” consisting of the biodegradable material.
  • the portions 100” are situated between the tines 20” and may extend such that only a base portion 200 is integrally connected to each tine 20”.
  • the portion 100” is completely degraded and parts of the tines 20”, preferably the tips protruding from the housing 4, are separated from the annular ring 10” (see Fig. 3B).
  • the device 5 is anchored by the ingrowth of the housing 4 only.
  • the tines 20” remain in the tissue, which due to complete ingrowth is not problematic.
  • the base portion 200 may consist of biodegradable material, and the portions 100” may consist of a material which is not biodegradable.
  • the annular ring 10” completely consists of the biodegradable material. In all embodiments, the tines 20” are separated from the device 5 after the biodegradable material is degraded.
  • the support member 3 may comprise recesses 30’ 30”, which are aligned to either portion 100’ or 100” in order to enable bodily tissue to get in contact with the portions 100’, 100” (see Figs. 2C, 3C).
  • the support member 3 comprises a material, which is bio stabile and not biodegradable.
  • the recesses 30’, 30” however are filled with a biodegradable material, for example a biodegradable polymer, which may degrade faster than the biodegradable material of portions 100’, 100”.
  • the recesses may be filled with a material, which is not permeable for bodily fluids under normal conditions, but may be converted by an external trigger into a form, in which it is permeable for bodily fluids in order to start degradation of the portions 100’, 100”.
  • a material which is not permeable for bodily fluids under normal conditions, but may be converted by an external trigger into a form, in which it is permeable for bodily fluids in order to start degradation of the portions 100’, 100”.
  • a material which is not permeable for bodily fluids under normal conditions, but may be converted by an external trigger into a form, in which it is permeable for bodily fluids in order to start degradation of the portions 100’, 100”.
  • technology disclosed in document US 2011/0276124 Al can be used.
  • the degradation process of portions 100’, 100” can be started at the right time.
  • the support member 3’ which establishes secure attachment of anchoring device 1 to the housing 4 of the device 5, is made of a biodegradable material, for example a biodegradable polymer or a biodegradable ceramic.
  • the whole support member 3’ dissolves in an adjusted time, which leads to a detachment of the anchoring device 1 from the housing 4 (Fig. 4B).
  • the housing 4 may be easily detached and be explanted, while particularly the tines 20 or the tine array remain in the body, as exemplarily shown in Fig. 4C, wherein the tines 20 may be made of a biostable, biocompatible material, such as, e.g. ninitol.
  • the design of the tines 20, 20’, 20” of the embodiments shown in Figs. 1 to 4 is exemplary only and not limited to the exactly shown shape. Other shapes and amount of tines are possible.
  • anchoring device Use of a biodegradable material for the anchoring device allows sufficient anchoring of the device during the acute implant and chronic encapsulation or ingrowth phase. After the encapsulation or ingrowth period, the anchoring device is partly or completely dissolved and the device is anchored by the encapsulation around the device only.
  • Fig. 5 shows the implantable medical device 5 that comprises the anchoring device 1 with at least one tine 20 in an initial state before implantation or shortly after.
  • the anchoring device 1 is initially used to anchor the housing 4 of the implantable medical device 5 to bodily tissue.
  • the anchoring device 1 is formed for a temporary fixation of the device 5 to tissue.
  • the anchoring device 1 may comprise at least in part (or completely) the biodegradable material disclosed herein.
  • the anchoring device 1 can be formed particularly according to one of the embodiments shown in Figs. 1 to 4. With other words, the “active” anchoring with means of the anchoring device terminates and the implantable medical device 5 is anchored “passively” by the at least partial encapsulation of the (e.g. cylindrical) housing 5.
  • the surface of the housing 4 comprises a motion-converting structure 50, which upon twisting the implantable medical device (for example by attaching the proximal end of the housing 4 to an explantation device known from the art, which comprises means suitable to transfer rotational movements to the housing) creates a movement of the device 5 along the longitudinal axis in proximal direction.
  • the motion-converting structure 50 may be formed along the whole surface, e.g. extending helically from the distal end of the housing 5 to the proximal end of the housing 5. It may also extend only partially on the outer surface, for example on the most distal half of the housing, a middle part or a distal part.
  • the motion-converting structure 50 may protrude from the surface of housing 4. It may be formed on the housing 4 by gluing, welding or soldering material on the housing 4, or by embossing the sheath-like metal of the housing 4.
  • the motion-converting structure 50 may also be in form of a groove in the surface of housing 4.
  • the housing or the housing parts facing to the tissue are preferably made of titanium or a titanium alloy, particularly since titanium causes rather the formation of a bodily mucus or gel than becoming ingrown by tissue, which in turn significantly improves the explantability of the device.
  • the motion-converting structure 50 is in the form of a thread, which is wound helically around the surface of the housing 4.
  • the embodiments disclosed herein may have the advantage that they combine the safety of the tined implant approach and the explantability of the helix approach.
  • Helices are known to be sensitive to heart wall contact forces, number of turns during deployment, and the nature of the tissue in contact with the helix. Excessive turning can lead to damage of the tissue. Tines do not have this problem.
  • tines are difficult to remove once the device is encapsulated due to the adhesion forces of the capsule. These forces can be overcome with lower risk by twisting the device.
  • this device can avoid helix problems during implant and avoid tines problems during explant, since the tines would not obstruct rotation after dissolving.
  • the embodiment shown in Fig. 5 allows the extraction of an implantable medical device without applying pulling forces on the anchoring, which may lead to damage of the anchoring tissue or the encapsulation.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un dispositif médical implantable (5) comprenant un boîtier (4), et un dispositif d'ancrage (1) couplé au boîtier (4). Le dispositif d'ancrage (1) est conçu pour fournir une fixation temporaire du boîtier (4) à des tissus. Le boîtier (4) comprend une structure de conversion de mouvement (50) qui est conçue pour convertir une rotation du boîtier (4) en un mouvement linéaire du boîtier (4).
PCT/EP2022/050021 2021-01-15 2022-01-03 Dispositif médical implantable WO2022152585A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202163137957P 2021-01-15 2021-01-15
US63/137,957 2021-01-15
EP21159141.7 2021-02-25
EP21159141 2021-02-25

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US20140324145A1 (en) * 2013-04-24 2014-10-30 Medtronic, Inc. Electrode assemblies and associated fixation members for implantable medical devices
US20150165189A1 (en) * 2013-12-04 2015-06-18 Sorin Crm Sas Intracardiac capsule implantable on a thin wall, including the septum wall
US20180168687A1 (en) * 2016-12-21 2018-06-21 Medtronic, Inc. Apparatus for forming a passageway in tissue and associated interventional medical systems
WO2018200479A1 (fr) * 2017-04-25 2018-11-01 Jeffry Melsheimer Systèmes de fixation de tissu

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WO2009006531A1 (fr) * 2007-07-03 2009-01-08 Ebr Systems, Inc. Minimisation de l'énergie de stimulation tissulaire en utilisant un micro-stimulateur
US20110276124A1 (en) 2010-05-06 2011-11-10 Biotronik Ag Biocorrodable implant in which corrosion may be triggered or accelerated after implantation by means of an external stimulus
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