WO2011069270A1 - Dispositif d'ancrage pour conducteur dans un trou percé dans un crâne - Google Patents

Dispositif d'ancrage pour conducteur dans un trou percé dans un crâne Download PDF

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Publication number
WO2011069270A1
WO2011069270A1 PCT/CH2010/000306 CH2010000306W WO2011069270A1 WO 2011069270 A1 WO2011069270 A1 WO 2011069270A1 CH 2010000306 W CH2010000306 W CH 2010000306W WO 2011069270 A1 WO2011069270 A1 WO 2011069270A1
Authority
WO
WIPO (PCT)
Prior art keywords
base part
anchoring device
line
skull
borehole
Prior art date
Application number
PCT/CH2010/000306
Other languages
German (de)
English (en)
Inventor
Jörg HUMMEN
Cyrill RÖTHLIN
Claudio Steiner
Original Assignee
Carag Ag
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 Carag Ag filed Critical Carag Ag
Priority to EP10787989A priority Critical patent/EP2509673A1/fr
Priority to US13/514,002 priority patent/US20120245529A1/en
Publication of WO2011069270A1 publication Critical patent/WO2011069270A1/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526Head electrodes
    • A61N1/0529Electrodes for brain stimulation
    • A61N1/0539Anchoring of brain electrode systems, e.g. within burr hole
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • A61M2025/0213Holding devices, e.g. on the body where the catheter is attached by means specifically adapted to a part of the human body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • A61M2025/0246Holding devices, e.g. on the body fixed on the skin having a cover for covering the holding means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • A61M2025/028Holding devices, e.g. on the body having a mainly rigid support structure

Definitions

  • Anchoring device for guidance in a skull borehole
  • the present invention relates to an anchoring device for anchoring a conduit in a skull borehole according to the preamble of patent claims 1 and 15, respectively.
  • Various methods and agents for cerebellar diagnostics and / or therapy are known in the art which require guidance through a skull of a skull. Examples include electrical brain stimulation devices, blood flow and blood flow measurements, pressure measurements, drug delivery, and tissue fluid aspiration.
  • the line is thereby fixed or anchored in the borehole to avoid accidental injury to the brain. In particular, movements in the longitudinal direction of the line should be avoided.
  • screwable anti-crush devices are used.
  • Various anchoring devices are known in the art. There are devices that are located under the scalp. In this case, the conduit generally still travels a certain distance between the skull and scalp along the skull before exiting the scalp. In other applications, the anchoring device penetrates the scalp. The line is then usually glued with appropriate adhesive tape on the scalp.
  • Such anchoring devices are known for example from US Pat. No. 6,923,799, US Pat. No. 4,677,985 and US Pat. No. 7,553,290.
  • US Pat. No. 6,044,304 describes an annular base part with a central perforated plate, through whose holes the conduit can be led out.
  • the ring body has radially extending depressions, so that the outwardly guided lines extend in the smallest possible angle to the skull.
  • US 5 843 150 shows a base part and an upwardly open cover.
  • the lid has on the side a passage opening for the passage of the line.
  • US 5 927 277 uses a clamping ring insert in the base part and the conduit is led out of the skull through a lateral recess in the base part. The opening is closed here with a plug.
  • US 2005/0182464 discloses still further, relatively complicated built-up devices.
  • the anchoring device according to the invention for anchoring a conduit in a skull borehole has a base part and a lid which tightly seals the base part.
  • the base part has a fixing element for fixing the base part in the borehole and a passage opening for passing the line out of the borehole to an outside of the anchoring device.
  • In the base part is a between borehole and outside extending contact surface for installation of the line available.
  • the contact surface is formed in a constant direction gelkrümmt, so that the line in the same direction and with a radius of curvature which is equal to or greater than a predefined minimum Radius of curvature is guided from the inside of the skull to the outside.
  • the curvature preferably runs continuously, ie steplessly and is preferably bent towards the longitudinal central axis of the device.
  • the entire arrangement is preferably aligned centrally with respect to the longitudinal central axis of the device.
  • the device according to the invention not only fixes the conduit, but also prevents it from being squeezed or kinked. Since the lines are not bent too much and thus a crushing or kinking is impossible, their functionality is guaranteed. This is especially important for drainage hoses and fiber optic cables.
  • anchoring device is used in the following: The same device is also called a "port” or “lock.” Under the heading of a conduit, a probe, a catheter, a drainage tube, an electrode or a different type of conduit is understood.
  • a passageway for receiving the conduit is present, which is formed on the one hand by the contact surface and on the other hand by the lid.
  • the lid closes the base part except for the formation of the passage channel form-fitting manner.
  • it preferably has an inner surface, which is adapted to the contact surface of the base part and presses the line to the contact surface.
  • a radially extending groove is present in the base part, in which the line can be inserted.
  • the line is positively held clamped in the groove 22.
  • the conduit is also supported outside the passageway from the base and directed at a relatively shallow angle and kink-free on the skull or scalp.
  • This can be done, for example, with at least reach a radially outwardly projecting nose.
  • This nose has an upper side, which connects continuously and thus continuously to the curved contact surface and serves as an outer inclined to the skull contact surface for the line. If several lugs are present, then the line can be led out of the base part on an optimized side, without the base part having to be brought into a different rotational position for this purpose.
  • This embodiment can also be used without a curved inner region, ie without an inner cone.
  • the fixing element has an external thread, which can be screwed into the wellbore.
  • this external thread is self-tapping.
  • the screwing in of the base part can be facilitated if there are several, in particular three, noses which are arranged equidistantly over the outer circumference of the base part. These noses serve as turning handles for screwing the base part into the borehole. They may be identical to the above-mentioned, serving as a support surface for the line noses or be formed by other noses.
  • the through-opening has a funnel, wherein the funnel tapers towards the borehole and wherein the inside of the funnel is arched, in particular convex, toward the longitudinal center axis of the funnel.
  • the lid also has a conical closure body projecting towards the base part and thus forms a positive connection in this area.
  • the base part may be formed partially or in total in one piece.
  • at least the base body and the insert element can be formed integrally and the seal form a separate part.
  • it is designed in several parts.
  • it may comprise an annular body with a central passage opening and an insert element held in the central passage opening of the annular body, wherein the insert element forms the funnel.
  • a neck is preferably present on the fixing element, which has a larger diameter than the external thread and between the external thread and the remaining base part is arranged.
  • an annular seal for sealing fixation of the line is present in the base part. If the ring seal is formed with an obliquely projecting resilient skirt, then the line can be easily pushed in the direction of the skull interior, but only very difficult to pull out.
  • the lid closes the base part and thus the borehole tight. It forms a bacterial protection or protection against migration of microorganisms and / or dirt particles over several days and weeks.
  • an antibacterial agent for example a gel
  • an antibacterial coating for example, with silver ions attach.
  • the inventive device allows by means of the seal, in particular the circular sealing lips, and an antimicrobial substance arranged above, in particular in gel, a double encapsulation against migration of microorganisms and / or dirt particles.
  • the lid is provided with radially outwardly projecting flanges or straps, it can be attached to a scalp or the skull. He can be especially sew on the scalp. Further embodiments are given in the dependent claims.
  • Figure 1 is an exploded view of an inventive anchoring device in a perspective view according to a first embodiment
  • Figure 2 is a partial exploded view of the anchoring device according to
  • FIG. 3 shows a longitudinal section through the anchoring device according to FIG. 1 in the assembled state
  • Figure 4 is a view of a lid of the anchoring device according to Figure 1 from below obliquely;
  • Figure 5 is a view of the intended composition
  • Anchoring device from a first side
  • FIG. 6 shows a view of the anchoring device according to FIG. 5 from a second one
  • FIG. 7 shows a perspective view of a base part according to the invention in a second embodiment
  • FIG. 8 shows a perspective view of the base part according to FIG. 7 with a cover according to the invention in accordance with this second embodiment from a first side;
  • Figure 9 is a perspective view anchoring device according to Figure 8 from a second side;
  • Figure 10 is a perspective view of the lid according to Figure 9 from below;
  • Figure 11 is a partial section in an exploded view of the inventive
  • FIG. 12 shows a partial section of the anchoring device according to FIG. 11 from a second side.
  • Figure 1 shows a preferred embodiment of the inventive anchoring device in an exploded view. It consists of at least two parts, a cover 1 and a base part 2, 3, 4, 5.
  • the base part may be integrally formed, or as shown here, several pieces.
  • the base part consists of an annular body 2, an insert element 3, a seal 4 and a fixing element 5.
  • the cover 1 is preferably formed in one piece.
  • the cover 1 is preferably made of an elastic or at least soft plastic, for example silicone.
  • the annular body 2 is preferably made of a hard plastic, such as polycarbonate.
  • Insert element 3 and fixing element 5 are preferably made of metal or plastic, for example made of titanium or polycarbonate.
  • the seal 4 is preferably made of silicone.
  • the cover 1 has a main body 10, which has an approximately plane cover surface 14 and an approximately cylindrical jacket 17.
  • the transition region 18 between the top surface 14 and shell 17 is formed bent.
  • fastening elements 21 are formed by brackets 11, which each enclose a mounting hole 12.
  • the brackets 11 are arranged on the lower, in the implanted state the skull facing side of the cover shell 17.
  • the jacket 17 also has downward, towards the skull, open recesses 19 (see Figure 4). These are preferably arranged centrally between the brackets 11 and preferably in the same number as the brackets, but in any case in the same number as the below-mentioned tabs 21 of the base part 2 is present.
  • One of these recesses 19 is extended at the top by an inlet opening 13.
  • On the top surface 14 is preferably a mark 15, here an arrow, so the position of the passage opening 13 is visible from above, ie from the top surface.
  • the inlet opening 13 is arranged centrally between two fastening elements 11.
  • an inwardly projecting closure body 16 is integrally formed on the top surface 14.
  • This closure body 16 tapers downwards and forms a cone, ie a cone or a truncated cone, with a curved lateral surface or bent flanks.
  • the lateral surface is preferably formed curved inwards.
  • the ring body 2 has an annular base body 20, which encloses a central passage opening 23. Its skull-facing bottom 24 is preferably concave. Its upper top surface 27 is preferably flat and its jacket 25 is substantially cylindrical. The transition region 26 between the top surface 27 and jacket 25 is also formed bent.
  • the outer basic shape of the ring body 2, ie the top surface 27, the shell 25 and the transition region 26 correspond in shape and dimensions of the shape and dimensions of the inside of the lid 1. Also, the outer cross-sectional shape of the lugs preferably corresponds to the shape of the recesses 19.
  • the dimensions of these parts of the ring body 2 are slightly larger so that the lid 1, when it is slipped over the ring body 2, thanks to its elastic material sealingly against the top surface 27, the transition region 26 and the jacket 25 of the ring body 2.
  • the annular body 2 also has the jacket 25 radially projecting lugs 21.
  • the upward, ie toward the lid 1, directed surface 210 of the lugs 21 is formed radially lowering outwardly.
  • the downwardly directed, ie toward the skull, directed surface 220 is preferably designed to extend at a constant height, so that the thickness of the lugs 21 reduces radially outwards.
  • three such lugs 21 are arranged gleichabstieri on the circumference of the ring body 2.
  • lugs 21 are preferably on the jacket 25th formed and located in the lower region, but preferably spaced from the lower edge of the ring body second
  • the ring body 2 also has radially extending grooves 22, which connect the central passage opening 23 with the outside of the ring body 2.
  • these grooves 22 terminate at the lugs 21 so that they each extend along the same radius.
  • the base of the grooves 22 are also formed outwardly inclined downwardly, preferably continuously, i. steadily, go over into the surface of the noses 21.
  • the lugs 21 extend to the upper end of the shell 25 of the ring body 2 or they end just below.
  • the insert element 3, the seal 4 and the fixing element 5 are clearly visible in FIG. In this figure 2 they are already connected to the ring body 2.
  • the insert element 3 is arranged in the central passage opening 23, wherein it is preferably pressed into this.
  • the outer side of the insert element 3 and the wall of the central through-opening 23 have for this purpose preferably both in the form of a hexagon, as can be seen in Figure 1. However, any other shapes can also be used.
  • the insert element 3 has an inclined inner surface which slopes downwards, i. towards the skull, rejuvenated. This results in a central funnel-shaped opening with preferably curved flanks 30. In the intended assembly of the base part, the upper edge of this flank 30 or this funnel is aligned with radially extending grooves 22. It forms a stepless and thus continuous transition to the bottom of these grooves 22nd
  • the insert element 3 thus has a large upper passage opening and a small lower passage opening, which are connected to one another via a bent area.
  • the insert element 3 is inserted with its lower opening in the fixing element 5, wherein the seal 4 is held in this connection region.
  • the fixation of these three parts 3, 4, 5 relative to each other can be done in different ways.
  • the seal 4 may be inserted into the fixing element 5, these two parts 4, 5, pressed together in the insert element 3 and be welded and these three parts 3, 4, 5 be pressed into the ring body 2.
  • the seal 4 is preferably a ring seal.
  • it is resilient.
  • it consists of two circumferential sealing lips, which form an angle.
  • it has a circumferential sealing lip directed towards the longitudinal axis of the arrangement and thus protruding into the lower passage opening of the insert element 3. It rests with a second sealing lip on an approximately cylindrical inner surface of the fixing element 5.
  • This seal fixes the line in its position within the fixing element. Thanks to its shape, it makes it easy to import the pipe and makes it difficult to pull it out.
  • the seal 4 forms a protection against the migration of microorganisms and / or dirt particles into the skull.
  • the fixing element 5 has a plug body 50, which may be formed, for example, hollow cylindrical. Preferably, however, it is, as shown here, frusto-conical shaped with downwardly tapering diameter and an axial passage opening. This conical shape has the advantage that, when the fixation element 5 is screwed into the borehole, chips that are produced are transported outwards and can not get into the brain structures.
  • the plug body 50 has an external thread 51 over at least part of its axial length.
  • the upper, the ring body 2 facing neck 52 of the fixing element 5 preferably has a wider diameter than the plug body 50, wherein the transition is formed as a step.
  • This neck 52 is preferably also frusto-conical, whereby its diameter also increases towards the ring body 2.
  • the anchoring device according to the invention is shown in the assembled state as intended.
  • the lid 1 is slipped over the ring body 2, wherein the inlet opening 13 is located over one of the lugs 21 and forms with one of the grooves 22 part of a through-channel 6.
  • This passageway 6 extends from the lower End face of the fixing element 5, over the central lower opening of the insert element 3, over the curved flanks 30 of this insert element 3 to the outside of the ring body 2. As can be seen in Figure 3, closes the lid 1, the remaining areas and in particular the flanks 30 of the insert element 3 in a sealed way.
  • the lid 1 is shown in a view obliquely from below.
  • the inlet opening 13 of the shape of the inside of the lid 1 corresponding to the center and thus to the lowermost tip of the closure body 26 extends.
  • the axial or central end of the inlet opening 13 here merges into a channel open on one side and has the reference numeral 13 '.
  • FIG. 5 shows a perspective view of the anchoring device assembled as intended from a first side, in which the inlet opening 13 arranged above a nose 21 is visible.
  • Figure 6 shows the same device from another side, it being understood that the other nose 21 is sealingly covered by the lid 1 and no opening is present. The third nose 21 is sealed by the lid 1, although this is not recognizable here.
  • This anchoring device according to the invention can now be used as follows: After a borehole has been drilled in a skull, the base part can be screwed into the borehole by means of the fixing element 5 through the scalp and thus fixed in the skull.
  • the protruding lugs 21 of the ring body 2 facilitate the screwing of the fixing element 5, since they serve as a holder for the hand of the surgeon and thus form a relatively large and well controllable lever when screwing the part.
  • the neck 52 serves as a spacer between the skull and the scalp. Preferably, the length of the neck 52 is approximately equal to a typical thickness of a scalp.
  • the concave lower surface 24 of the ring body 2 is approximately adapted to the shape of the skull. If the base part is fixed, depending on the field of application, a conduit, in particular a probe, a catheter, a drainage tube, an electrode or a different type of conduit will now be guided through the through-channel 6, which is clearly visible in FIGS. 4 and 5.
  • the line is thereby through the ring body 2, the insert element 3, the ring seal 4 and the fixing element 5 into the interior of the Skull led. It lies on the curved cone of the insert element, so that this cone serves as a contact surface.
  • the line is further placed in one of the grooves 22 of the ring body 2, which also serve as a contact surface.
  • the grooves 22 are dimensioned so that the line must be pressed into it and is held positively in position.
  • the grooves 22 may have a cross-section which corresponds to a pitch circle, this pitch circle being larger than a semicircle, ie its ends enclosing an angle of more than 180 °.
  • the line is fixed in position in the passageway 6 and they can not move in particular in their longitudinal direction.
  • the seal 4 the positive connection in the groove 22, the positive connection through the cover 1 and, thanks to the deflection, the cable is held in position by more than 90 °.
  • the continuous passages as well as the ramp-shaped, the curved surfaces and the nose 21, which slopes towards the skull, the duct is guided in a gentle radius to the outside of the skull or to the outer scalp.
  • the outer, i. not subcutaneous area of the line can be fixed on the head.
  • the line is in the region of the anchoring device (also called port) exposed to any tensile or compressive forces and it is particularly not kinked. This is particularly advantageous in the case of glass fiber cables, drainage hoses or other lines with continuous lumen, since their permissible minimum bending radius can be taken into account by appropriate shaping of the base part.
  • FIGS. 7 to 12 show a second embodiment of the anchoring device according to the invention. Identical parts are provided with the same reference numerals. The above description also applies to this embodiment and is therefore not repeated.
  • the anchoring device differs from the first example above all in that the grooves 22 do not end in the main body 20 but also extend over the lugs 21. This is clearly visible in particular in FIG.
  • the transition of the grooves 22 from the base body 20 to the lugs 21 takes place continuously, so steadily.
  • the groove base tilts more and more towards the bottom 220 of the nose 21, so that the transition of the line after the outer end of the groove 22 to the skull or the scalp out only has a low level and thus can be done very flat angle.
  • FIGS. 8 and 9 show the base part according to FIG. 7 with a cover 1 pushed over it.
  • the through-channel 6, through which the line is led out, is open, since the cover has a corresponding inlet opening 13.
  • the grooves 22 of the two other lugs 21 are closed to the outside, as can be seen in Figure 9.
  • the cover 1 has for this purpose each a radially extending locking rib 190. These ribs 190 are clearly visible in FIG.
  • the lid 1 closes preferably the funnel of the insert element 3 with a cone-shaped closure body 16, wherein it has a recess to allow passage of the line from the funnel of the insert element 3 to the outside of the anchoring device.
  • This passage is formed by the already mentioned inlet opening 13, or inlet channel.
  • the central end of this inlet opening or of the inlet channel is designated in FIG. 12 by 13 '.
  • the anchoring device makes it possible to lead a conduit out of a drill hole of a skull at a slight angle, without the conduit being bent too much or even being bent.
  • Main body 23 central passage opening

Abstract

L'invention concerne un dispositif d'ancrage destiné à ancrer un conducteur dans un trou percé dans un crâne, lequel dispositif présente une partie de base (2, 3, 4, 5) et un couvercle (1) fermant de manière étanche la partie de base. La partie de base dispose d'un élément de fixation (5) destiné à fixer la partie de base dans le trou percé et d'une ouverture de passage pour faire passer le conducteur du trou percé vers un côté extérieur du dispositif d'ancrage. Une surface de support (30, 22) destinée à supporter le conducteur s'étend entre le trou percé et le côté extérieur dans la partie de base. La surface de support est conçue incurvée dans une direction constante de sorte que le conducteur est guidé en direction constante et avec un rayon de courbure qui est égal ou supérieur à un rayon de courbure minimal prédéfini de l'intérieur du crâne vers le côté extérieur. Ce dispositif d'ancrage permet de faire sortir à un angle plat un conducteur du trou percé dans un crâne sans que le conducteur soit fortement incurvé ou même plié.
PCT/CH2010/000306 2009-12-11 2010-12-02 Dispositif d'ancrage pour conducteur dans un trou percé dans un crâne WO2011069270A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP10787989A EP2509673A1 (fr) 2009-12-11 2010-12-02 Dispositif d'ancrage pour conducteur dans un trou percé dans un crâne
US13/514,002 US20120245529A1 (en) 2009-12-11 2010-12-02 Anchoring device for a line in a skull bore hole

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CH1907/09 2009-12-11
CH01907/09A CH702371A1 (de) 2009-12-11 2009-12-11 Verankerungsvorrichtung für Leitung in einem Schädel-Bohrloch.

Publications (1)

Publication Number Publication Date
WO2011069270A1 true WO2011069270A1 (fr) 2011-06-16

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PCT/CH2010/000306 WO2011069270A1 (fr) 2009-12-11 2010-12-02 Dispositif d'ancrage pour conducteur dans un trou percé dans un crâne

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US (1) US20120245529A1 (fr)
EP (1) EP2509673A1 (fr)
CH (1) CH702371A1 (fr)
WO (1) WO2011069270A1 (fr)

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EP2509673A1 (fr) 2012-10-17
CH702371A1 (de) 2011-06-15

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