WO2016150695A1 - Dispositif implantable servant à former un passage permanent à travers la peau - Google Patents

Dispositif implantable servant à former un passage permanent à travers la peau Download PDF

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Publication number
WO2016150695A1
WO2016150695A1 PCT/EP2016/054915 EP2016054915W WO2016150695A1 WO 2016150695 A1 WO2016150695 A1 WO 2016150695A1 EP 2016054915 W EP2016054915 W EP 2016054915W WO 2016150695 A1 WO2016150695 A1 WO 2016150695A1
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WO
WIPO (PCT)
Prior art keywords
counter
plate
skin
transcutaneous
anchor
Prior art date
Application number
PCT/EP2016/054915
Other languages
German (de)
English (en)
Inventor
David Liebetanz
Original Assignee
Georg-August-Universität Göttingen - Stiftung Öffentlichen Rechts/Universitätsmedizin
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 Georg-August-Universität Göttingen - Stiftung Öffentlichen Rechts/Universitätsmedizin filed Critical Georg-August-Universität Göttingen - Stiftung Öffentlichen Rechts/Universitätsmedizin
Publication of WO2016150695A1 publication Critical patent/WO2016150695A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6879—Means for maintaining contact with the body
    • A61B5/6882—Anchoring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/296—Bioelectric electrodes therefor specially adapted for particular uses for electromyography [EMG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/48—Operating or control means, e.g. from outside the body, control of sphincters
    • A61F2/482—Electrical 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0209—Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
    • A61B2562/0215—Silver or silver chloride containing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/055—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves  involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/107—Measuring physical dimensions, e.g. size of the entire body or parts thereof
    • A61B5/1072—Measuring physical dimensions, e.g. size of the entire body or parts thereof measuring distances on the body, e.g. measuring length, height or thickness
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6865—Access ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0858—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving measuring tissue layers, e.g. skin, interfaces
    • 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
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0261—Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in the body

Definitions

  • the invention relates to an implantable device for forming a permanent skin penetration through a skin comprising an epidermis and an underlying dermis, with the features of the preamble of independent claim 1.
  • the implantable device for forming a skin passageway through a provided for human skin may be a transcutaneous electrode.
  • a transcutaneous electrode can be used, for example, to derive electrical signals from a muscle for the purpose of driving a prosthesis.
  • the present invention relates to a plurality of such implantable devices and to a method of manufacturing such an implantable device.
  • a transcutaneous electrode for forming a skin leadthrough having the features of the preamble of independent claim 1 is known from WO 2008/043065 A2.
  • the transcutaneous electrode comprises a transcutaneous element that extends through the epidermis and the dermis of the skin when the skin is formed. At one end of the transcutaneous element is radially from the transcutaneous element from a radial flange as a subcutaneous anchor, which rests with trained skin passage with its upper side from below to the dermis.
  • the transcutaneous element and the subcutaneous anchor are integrally formed.
  • the entirety of the transcutaneous element and the subcutaneous anchor can be electrically conductive, or an electrical conduction path extends only through the center of the transcutaneous element to the underside of the hypodermic anchor, while the remainder of the device is made of electrically insulating material.
  • the known transcutaneous electrode is implanted by making a straight cut in the skin and then pushing the subcutaneous anchor under the skin.
  • the known transcutaneous electrode can be formed using biocompatible materials that bind to living tissue, such as the dermis or epidermis, to form a seal.
  • a fibrous and / or porous layer may be formed, which promotes the growth of the dermis.
  • the attachment of the dermis to the transcutaneous electrode is promoted and the ingrowth of the epidermis is blocked.
  • Such a growth layer, the transcutaneous element and / or the subcutaneous anchor may also be coated or impregnated with an antimicrobial agent.
  • the known transcutaneous electrode can also be implanted upside down, so that the radial collar projecting from the transcutaneous element rests on the dermis. In practical use, it turns out that the known transcutaneous electrode migrates, ie changes its position relative to the adjacent tissue during movements of its wearer. This hinders a desired ingrowth of the electrode.
  • the known transcutaneous electrode must have a clear supernatant of its transcutaneous element via the epidermis, so that the transcutaneous element does not unintentionally completely enter the skin and thus the transcutaneous electrode can be contacted without any problems.
  • the practical use of the known transcutaneous electrode, for example for driving prostheses, is therefore very limited.
  • an implantable subcutaneous electrical socket and an associated percutaneous plug are known.
  • the socket and plug serve to control and / or power an implanted medical device, such as a bone distraction motor, within a patient.
  • the subcutaneous electrical socket has sockets for receiving hollow needles that protrude from the plug and that are pricked by the skin over the socket. Through the hollow needles then current electrodes for making an electrical contact between see the plug and the socket are pushed into the respective socket.
  • the known subcutaneous electrical socket and the corresponding percutaneous plug are only suitable for producing a temporary electrical connection at greater intervals.
  • US Pat. No. 4,535,779 discloses an electrode which is only referred to as transcutaneously and which has an electrode body which is acted upon elastically on the surface of the skin.
  • the elastic loading of the electrode body via a spring which is supported on a wall of gypsum or other plaster material.
  • the support takes place via a projecting at one end of a hollow cylinder radial flange on the skin facing the underside of the wall, against which a further radial flange is screwed on the top of the wall via an external thread on the outer circumference of the hollow cylinder.
  • J P 2012-187320 A a device for forming a passage for the insertion of an endoscopic surgical instrument in vivo is known.
  • This device has a fixation area, which can be inserted into a skin incision.
  • This fixing region comprises a hollow cylindrical section, at the two ends of which radial flanges of the same outside diameter protrude.
  • US Pat. No. 4,321,914 A discloses an implantable device for forming a permanent skin penetration through a skin with an epidermis and an underlying dermis, in which a tailored transcutaneous element extends through the epidermis and the dermis when the skin is formed.
  • the transcutaneous element widens conically from its waist to below the dermis.
  • the conical part of the transcutaneous element thus serves as a subcutaneous anchor.
  • the diameter of the transcutaneous element also increases above the waist to which the epidermis adjoins when the skin is formed, albeit at a lower pitch and to a lesser extent than below the waist.
  • the outer surface of the truncated cone portion of the transcutaneous element forming the subcutaneous anchor is clad with a special growth material of PTFE.
  • the transcutaneous element consists of a biocompatible material.
  • wires and the like can be passed in sealed form.
  • the sealing on the outside of the transcutaneous element is to be effected by planar growth of the dermis to the growth material and the edge-side growth of the epidermis to the growth material on the outer circumference of the transcutaneous element.
  • the epidermis is exposed up to the waist of the transcutaneous element. Forces up the upper part of the transcutaneous element, which projects far beyond the waist and thus over the skin, is connected by the conical shape of the hypodermic anchor with the danger of a widening of the opening in the skin.
  • a Transkutanelement has a cylinder jacket-shaped outer surface and an internal thread.
  • a subcutaneous anchor is arranged on the cylindrical outer surface, which strikes in the depth direction on a radial collar of the transcutaneous element.
  • the subcutaneous anchor extends through the dermis with a cylindrical shell-shaped region. Then its outer circumference increases conically until it ends in a radial flange below the dermis.
  • an outer plate of the known implantable device is defined at a defined distance from the flange of the hypodermic anchor.
  • the invention has for its object to provide an implantable device with the features of the preamble of independent claim 1, with a permanent skin penetration with minimized risk of complications can be formed.
  • the object of the invention is achieved by an implantable device having the features of independent claim 1.
  • the dependent claims 2 to 18 are directed to preferred embodiments of the device according to the invention.
  • the patent Claim 19 relates to a plurality of devices according to the invention; and claim 20 relates to a method for producing a device according to the invention.
  • An implantable device for forming a permanent skin passageway through a skin comprising an epidermis and an underlying dermis has a transcutaneous element extending through the epidermis and the dermis when the skin is formed, a hypodermic anchor attached to one end of the skin Transcutaneous element protrudes radially from the Transkutanelement and which rests with trained skin passage with its upper side from below to the dermis, and a counter-plate which projects at a distance from the hypodermic anchor on all sides radially from the Transkutanelement and opposite to trained at the skin penetration with the top of the hypodermic anchor Bottom of the top flat against the epidermis.
  • the implantable device according to the invention is supported on both sides of the skin: from below with the subcutaneous anchor abutting the dermis, from above with the counter-plate resting against the epidermis. Between the subcutaneous anchor and the counterplate extends the transcutaneous element, which defines the distance of the counterplate from the subcutaneous anchor. This distance is to be matched to the thickness of the skin, ie equal to or slightly smaller than the thickness of the skin to choose so that the back plate with light pressure from the outside rests on the skin, without damaging them, ie affect their metabolism or even to squeeze.
  • the counter-plate which abuts the epidermis in such a way prevents the transcutaneous element from migrating into the skin. The transcutaneous element therefore does not have to survive significantly beyond the skin to the outside.
  • the implantable device may end on its outside with the flat against the skin backing plate. That is, the device is minimally outwardly over the skin when trained through the skin. The risk that the device is forced by abutment against obstacles to movements against the adjacent skin is thereby minimized.
  • connection possibilities to the device on its outer side are provided with the counterplate, which not only make a transcutaneous element protruding beyond the skin superfluous for connection purposes, but also make it possible to keep the diameter of the transcutaneous element small. In this way, with the implanted device, only a small opening in the skin is connected, which is also filled by the Transkutanelement.
  • the counter-plate serves as a cover plate for the area of the skin through which the opening for the Transkutanelement leads.
  • the counter-plate prevents the unhindered approach of germs to the opening in the skin. It provides a mechanical shield against the simple penetration of germs along the transcutaneous element through the skin.
  • the subcutaneous anchor can also be plate-shaped and protrude on all sides radially from the transcutaneous element.
  • Plate shape means an at least substantially constant thickness of the subcutaneous anchor and an at least substantially constant distance of the subcutaneous anchor to the counter-plate.
  • the subcutaneous anchor can also be star-shaped or have one or more individually straight, curved or spirally protruding arms from the transcutaneous element.
  • a plate-shaped subcutaneous anchor as well as the counter-plate basically any, z. B. have a polygonal or ellipsenförmi- gene circumference.
  • the subcutaneous anchor and the counter-plate may be circular disc-shaped.
  • the transcutaneous element is preferably arranged in the center of the circular disk-shaped counter-plate or of the circular-disk-shaped subcutaneous anchor.
  • the diameter of the counter-plate of the device according to the invention is preferably smaller than the diameter of the plate-shaped subcutaneous anchor. In order to fulfill the anchoring function and the shielding function of the counterplate, this smaller diameter suffices.
  • the larger diameter of the hypodermic anchor prevents unwanted removal of the device from the skin.
  • the diameter of the circular disc-shaped subcutaneous anchor is more typically in a range of 5 to 15 mm. Well suited, for example, a diameter of about 8 mm.
  • the different diameters of the backplate and the hypodermic anchor ensure that the skin retains high mobility even in the area of the implanted device. In particular, they ensure that relative movements between the skin and the device are avoided.
  • the diameter of the transcutaneous element may be in a typical range of 0.3 to 3 mm.
  • its typical diameter is in a range of 0.3 to 1 mm. Concretely, it can be about 0.5 mm.
  • the thickness of the hypodermic anchor in the axial Direction of the transcutaneous element is to be chosen so large that the subcutaneous anchor has sufficient dimensional stability. Otherwise, it is as thin as possible in order to introduce as little foreign volume under the skin.
  • a typical thickness of the hypodermic anchor is in the range of 0.2 to 0.8 mm. It can be concretely at about 0.3 mm.
  • the counter-plate may have the same thickness as the subcutaneous anchor. Here, however, a slightly larger thickness of, for example, 0.3 to 1 mm may be useful in order to be able to attach an electrical connection more easily, for example, without deforming the counterplate.
  • Some or all surfaces of the device according to the invention may have antimicrobial properties. This applies in particular to the underside of the counterplate, an outer circumference of the transcutaneous element extending between the subcutaneous anchor and the counterplate, and the upper surface of the subcutaneous anchor. Along these surfaces, germs must move to overcome the skin in the area of the implanted device.
  • the antimicrobial properties of the respective surfaces may be given by the material of which the device according to the invention is formed. This may be z. For example, silver.
  • the mentioned surfaces can also be specifically provided with a coating with antimicrobial properties.
  • all or selected surfaces of the device according to the invention may be provided with a growth structure for body tissue.
  • a growth structure for body tissue may be provided with an outer peripheral region of the transcutaneous element adjoining the hypodermic anchor and extending toward the counterplate and / or the upper side of the hypodermic anchor.
  • the growth structure may be fibrous or porous. It can be formed directly from the material from which the device is otherwise formed. However, the growth structure can also be applied separately to the mentioned surfaces.
  • the distance between the subcutaneous anchor and the counter-plate is adjustable in order to be able to match it to the thickness of the respective skin.
  • the counter plate may have a threaded hole with an internal thread and the Transkutanelement a matching external thread. It is preferred if the external thread sealingly engages in the threaded hole, so that no passage paths for germs remain through the threaded hole along the external thread. alternative can be sealed after the adjustment of the distance between the subcutaneous anchor and the counter-plate when engaging the external thread in the threaded hole initially remaining passage paths. This sealing may include gluing, which at the same time defines the counter-plate on the transcutaneous element, so that the set distance is fixed.
  • the hypodermic anchor, the transcutaneous element and the counterplate are provided in a rigid arrangement with respect to one another from the outset, the counterplate also being closed in a germ-proof manner above the transcutaneous element from the outset.
  • the transcutaneous element is first produced separately from the subcutaneous anchor and the counter-plate and only then the subcutaneous anchor and the counter-plate are attached to or on the Transkutanelement. Even if the counter-plate is fixed on the outer circumference of the Transkutanelements in this attachment, for example, by welding a germ-tight closure of the counter-plate can be achieved.
  • the transcutaneous element in which the transcutaneous element has the shape of the section of a solid cylinder, can also comprise a hollow cylinder section. Its diameter is then typically a few millimeters. Through this hollow cylinder section electrical conductors, but also catheters can be passed. It is understood that the lumen of the respective hollow cylinder is to be sealed germ-tight around the conductors or catheters passed therethrough.
  • the hypodermic anchor may be electrically conductive and connected to the electrical conductor. From the subcutaneous anchor or directly from the electrical conductor of the transcutaneous element, additional electrical conductors can also be underneath the skin.
  • the electrical conductor encompassed by the transcutaneous element can end in an electrical connection contact.
  • This electrical connection contact may be the counter-plate, which is then also electrically conductive.
  • An electrical and / or mechanical and / or magnetic connection can be formed quite generally on the counterplate. It can be a connection for recording or connections of electrical conductors or catheters, such as. B. to be able to clip a groove in the outside of the counter-plate to a cable.
  • the counter-plate may be wholly or partly made of a permanent magnetic or ferromagnetic material to z. B. to fix a cable magnetically.
  • Such a magnetic connection can also serve for fixing one and / or for connection to a prosthesis.
  • an arm prosthesis can be slipped with its shaft over the transplanted device according to the invention, wherein an electrical contact to an electrical conductor of the device is magnetically secured.
  • the implanted device according to the invention is usefully sterile. It can be arranged in a germ-proof envelope for transport and stockpiling.
  • the defined by the transcutaneous element distance between the subcutaneous anchor and the counter-plate, which should be smaller than the thickness of the skin into which the device according to the invention is implanted, can be between 1 and 5 mm, in particular between 1 and 3 mm.
  • a plurality of devices according to the invention may have different distances defined by their transcutaneous elements between their subcutaneous anchors and their counterplates, so that from the plurality of devices suitable for a given skin thickness can be selected.
  • the thickness of the skin can be measured, for example, by ultrasound, even before the introduction of a section for introducing the hypodermic anchor under the dermis.
  • a method according to the invention for tailor-made production of a device according to the invention comprises the noninvasive measurement of the thickness of the skin, in particular with ultrasound.
  • the thickness of the skin can also be measured in other non-invasive ways, for example by computed tomography or magnetic resonance tomography.
  • the device is formed with a distance defined by the transcutaneous element between the subcutaneous anchor and the counterplate, which is equal to or slightly smaller than the thickness of the skin. Subsequently, the thus formed device is sterilized. Then she is ready for implantation in the previously measured skin.
  • FIG. 1 is a perspective view of an embodiment of the implantable device according to the invention.
  • FIG. 2 is a side view of the implanted device of FIG. 1 according to the invention.
  • FIG. 1 is a perspective view of an embodiment of the implantable device according to the invention.
  • FIG. 2 is a side view of the implanted device of FIG. 1 according to the invention.
  • FIG. 1 is a perspective view of an embodiment of the implantable device according to the invention.
  • FIG. 2 is a side view of the implanted device of FIG. 1 according to the invention.
  • Fig. 3 shows a further embodiment of the device according to the invention in one
  • Fig. 4 shows yet another embodiment of the device according to the invention in an axial section.
  • the apparatus 1 shown separately and implanted in FIGS. 1 and 2 comprises a circular disc-shaped subcutaneous anchor 2, a circular disc-shaped counter-plate 3 aligned parallel thereto and a center of the subcutaneous anchor 2 connecting the center of the counter-plate 3 and the distance between the counter-plate 3 and the latter
  • Subcutaneous anchoring transcutaneous element 4 The diameter of the transcutaneous element 4 is here about 0.5 mm, the diameter of the subcutaneous anchor 2 about 8 mm and the diameter of the counter-plate 3 about 3 mm.
  • the thickness of the subcutaneous anchor 2 is about 0.3 mm, the thickness of the counter-plate 3 about 0.6 mm.
  • the outer edge 6 is rounded in a circular arc, between the dermis 7 of the skin 5 and the subcutis 8. That is, with its top 9 of the subcutaneous anchor 2 from below dermis 7 on.
  • the transcutaneous element 4 passes through an opening in the dermis 7 and the epidermis 11 of the skin 5.
  • the counter-plate 3 rests with its lower side 12 against the upper side of the epidermis 11.
  • the distance defined by the transcutaneous element 4 between the counterplate 3 and the subcutaneous anchor 2 is matched to the thickness of the skin 5 such that this distance is equal to or slightly smaller than this thickness.
  • the thickness of the skin 5 is in the range of 1 to 3 mm.
  • the entire implantable device 1 can be made of antimicrobial material, ie of material with antimicrobial properties, such as silver.
  • the device 1 can also be provided with a separate antimicrobial coating, in particular on the underside 12 of the counter-plate 3 starting at its rounded outer edge, on the outer circumference of the transcutaneous element 4 between the counter-plate 3 and the Subcutaneous anchor 2 and at the top 9 of the hypodermic anchor 2.
  • germs have to move in order to get along the implanted device 1 through the opening 10 under the skin 5.
  • the antimicrobial formation of these surfaces effectively prevents penetration of these germs under the skin.
  • the device 1 can be manufactured individually with respect to the distance of the counter-plate 3 from the subcutaneous anchor 2, which is defined by the transcutaneous element 4, matched to the respective thickness of the skin 5.
  • the thickness of the skin 5 is to be measured, which can be done for example by ultrasound, before the device 1 is formed with respect to said distance.
  • the device 1 is to be sterilized before it can be implanted into the skin 5 through a slit in the skin 5.
  • the transcutaneous element 4 comprises a hollow cylinder section which forms part of a passage 13 through the counterplate 3, the transcutaneous element 4 and the subcutaneous anchor 2.
  • An electrical conductor 14, for example a sensor cable, and a catheter 15, for example an insulin tube, are led through this passage 13.
  • the transcutaneous element 4 is provided with an external thread 16 at its end remote from the hypodermic anchor 2.
  • the counter-plate 3 is screwed with a threaded hole 17, in which an internal thread is formed.
  • the set distance can then be fixed by gluing the threaded hole 17 with the external thread 16. In this way, at the same time paths in addition to the external thread 16 through the threaded hole 17, along which germs could move, are sealed germ-tight.
  • the free end of the external thread 16 can be used as an electrical connection contact to electrically contact the electrically conductive transcutaneous element 4 and the subcutaneously anchored to the transcutaneous element 4 integrally here.
  • One use of the device according to the invention is to electrically actuate subcutaneously arranged devices.
  • Another use of the device according to the invention is to read electrical signals from muscles in order to control, for example, a prosthesis which adjoins the outside of a limb covered by the skin.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
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  • Animal Behavior & Ethology (AREA)
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  • Oral & Maxillofacial Surgery (AREA)
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Abstract

L'invention concerne un dispositif implantable (1), notamment une électrode transcutanée destinée à commander une prothèse, ledit dispositif servant à former un passage à travers une peau (5) comprenant un épiderme (11) et un derme (7) sous-jacent. Ce dispositif (1) présente un élément transcutané (4) qui s'étend à travers l'épiderme (11) et le derme (7) lorsque le passage à travers la peau est formé, un élément d'ancrage sous-cutané (2) qui fait saillie radialement par rapport à l'élément transcutané (4) à une extrémité de ce dernier et dont la face supérieure (9) est en contact avec le derme (7) par le dessous lorsque le passage à travers la peau est formé, ainsi qu'une contre-plaque (3) qui fait saillie par rapport à l'élément transcutané (4) radialement de tous côtés, à distance de l'élément d'ancrage sous-cutané (2) et dont la face inférieure (12), opposée à la face supérieure (9) de l'élément d'ancrage sous-cutané (2), est en contact avec l'épiderme (11) par le dessus lorsque le passage à travers la peau est formé.
PCT/EP2016/054915 2015-03-26 2016-03-08 Dispositif implantable servant à former un passage permanent à travers la peau WO2016150695A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102015104583.4A DE102015104583A1 (de) 2015-03-26 2015-03-26 Implantierbare Vorrichtung zum Ausbilden einer permanenten Hautdurchführung
DE102015104583.4 2015-03-26

Publications (1)

Publication Number Publication Date
WO2016150695A1 true WO2016150695A1 (fr) 2016-09-29

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US3964470A (en) * 1974-07-25 1976-06-22 Medtronic, Inc. Percutaneous intradermal electrical connection system and implant device
US4321914A (en) 1980-04-22 1982-03-30 W. L. Gore & Associates, Inc. Percutaneous conduit having PTFE skirt
US4535779A (en) 1983-03-04 1985-08-20 Empi, Inc. Transcutaneous electrode device for cast-covered sites
US4578063A (en) * 1984-09-14 1986-03-25 W. L. Gore & Assoc., Inc. Central venous catheter
US4813967A (en) 1984-06-19 1989-03-21 Societe Nationale Industrielle Aerospatiale Process for forming a piece surgically implantable in an organism and a piece thus obtained
WO2008043065A2 (fr) 2006-10-05 2008-04-10 Bioness Inc. Système et procédé d'administration percutanée d'une stimulation électrique à un tissu organique cible
US20100042070A1 (en) * 2006-11-23 2010-02-18 Renishaw Plc Neurological apparatus comprising a percutaneous access device
JP2012187320A (ja) 2011-03-11 2012-10-04 Terumo Corp 内視鏡下手術用器具の生体内挿入路形成具
DE102012020260A1 (de) 2011-10-14 2013-07-18 Biomet Manufacturing Corp. Implantierbare subkutane elektrische Steckdose und perkutaner Stecker

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WO2008043062A1 (fr) 2006-10-05 2008-04-10 The Timken Company Procédé de durcissement duplex et articles ainsi fabriqués
WO2010125531A1 (fr) * 2009-04-30 2010-11-04 Alma Lasers Limited Dispositifs et procédés de traitement dermatologique
WO2011041463A2 (fr) * 2009-09-30 2011-04-07 Dexcom, Inc. Capteur d'analyte transcutané

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3540451A (en) * 1967-02-28 1970-11-17 William V Zeman Drainage cannula with tissue connecting assemblies on both ends
US3964470A (en) * 1974-07-25 1976-06-22 Medtronic, Inc. Percutaneous intradermal electrical connection system and implant device
US4321914A (en) 1980-04-22 1982-03-30 W. L. Gore & Associates, Inc. Percutaneous conduit having PTFE skirt
US4535779A (en) 1983-03-04 1985-08-20 Empi, Inc. Transcutaneous electrode device for cast-covered sites
US4813967A (en) 1984-06-19 1989-03-21 Societe Nationale Industrielle Aerospatiale Process for forming a piece surgically implantable in an organism and a piece thus obtained
US4578063A (en) * 1984-09-14 1986-03-25 W. L. Gore & Assoc., Inc. Central venous catheter
WO2008043065A2 (fr) 2006-10-05 2008-04-10 Bioness Inc. Système et procédé d'administration percutanée d'une stimulation électrique à un tissu organique cible
US20100042070A1 (en) * 2006-11-23 2010-02-18 Renishaw Plc Neurological apparatus comprising a percutaneous access device
JP2012187320A (ja) 2011-03-11 2012-10-04 Terumo Corp 内視鏡下手術用器具の生体内挿入路形成具
DE102012020260A1 (de) 2011-10-14 2013-07-18 Biomet Manufacturing Corp. Implantierbare subkutane elektrische Steckdose und perkutaner Stecker

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