EP2509673A1

EP2509673A1 - Anchoring device for a line in a skull bore hole

Info

Publication number: EP2509673A1
Application number: EP10787989A
Authority: EP
Inventors: Jörg HUMMEN; Cyrill RÖTHLIN; Claudio Steiner
Original assignee: Carag AG
Current assignee: Carag AG
Priority date: 2009-12-11
Filing date: 2010-12-02
Publication date: 2012-10-17
Also published as: WO2011069270A1; CH702371A1; US20120245529A1

Abstract

An anchoring device for anchoring a line in a skull bore hole comprises a base part (2, 3, 4, 5) and a cover (1) that tightly closes the base part (1). The base part has a fastening element (5) for fastening the base part in the bore hole and a passage opening for feeding the line from the bore hole to an outside of the anchoring device. A contact surface (30, 22) extending between the bore hole and the outside for laying the line is present in the base part. The contact surface is curved in a constant direction so that the line is guided from the skull interior to the outside in a constant direction and at a radius of curvature that is greater than or equal to a predefined minimum radius of curvature. Said anchoring device allows a line to be lead out of a bore hole of a skull at a flat angle without the line being bent too greatly or even kinked.

Description

TITLE

Anchoring device for guidance in a skull borehole

TECHNICAL FIELD 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.

STATE OF THE ART

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. For this purpose, preferably 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. In US 4,328,813 it is described that a conduit is clamped between a base part and a closure lid and thus leads out of the latter at a relatively small and shallow angle to the skull. 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.

PRESENTATION OF THE INVENTION

It is therefore an object of the invention to provide an anchoring device for anchoring or fixing a conduit in a skull-borehole, which is relatively simple and allows a flachwinkliges possible and safe lead out of the line from the borehole.

This object is achieved by an anchoring device having the features of claim 1. 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.

Nevertheless, the lines can lead out of the anchoring device close to the scalp or on the skull. This shallow angle minimizes the risk of injury to the patient's brain.

The term "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.

In a preferred embodiment, 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. Preferably, the lid closes the base part except for the formation of the passage channel form-fitting manner. For this purpose, 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. Preferably, a radially extending groove is present in the base part, in which the line can be inserted. Preferably, the line is positively held clamped in the groove 22. However, it is alternatively or additionally possible to provide a corresponding groove in the lid.

In a preferred embodiment, 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.

Preferably, the fixing element has an external thread, which can be screwed into the wellbore. Preferably, 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.

In a preferred embodiment, 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. Preferably, 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. In particular, at least the base body and the insert element can be formed integrally and the seal form a separate part. Preferably, however, it is designed in several parts. For example, 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.

So that the base element can not be screwed too deep into the borehole and thus presses neither on the scalp nor on brain structures, 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.

Preferably, 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. In order to optimize this protection, an antibacterial agent, for example a gel, can be introduced into the passage opening, in particular into the funnel of the base part and / or the grooves. It can also on the inside of the cover 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.

If 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.

BRIEF DESCRIPTION OF THE DRAWINGS Preferred embodiments of the invention will now be described with reference to the drawings, which are given by way of illustration only and not by way of limitation. In the drawings show: 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

Figure 1 in a partial section;

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 according to FIG. 3 from a first side

FIG. 6 shows a view of the anchoring device according to FIG. 5 from a second one

Page;

FIG. 7 shows a perspective view of a base part according to the invention in a second embodiment;

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

Anchoring device according to Figure 8 from a first side and FIG. 12 shows a partial section of the anchoring device according to FIG. 11 from a second side.

DESCRIPTION OF PREFERRED EMBODIMENTS

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. In this example, 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. From the jacket 17 are fastening elements 21 radially from. Here are three fasteners evenly distributed over the circumference. Another number, for example one, two, four or five is also possible. In this example, the fastening elements 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. Preferably, the inlet opening 13 is arranged centrally between two fastening elements 11. On the inside of the lid 1, 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. Preferably However, 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. Preferably, three such lugs 21 are arranged gleichabständig on the circumference of the ring body 2. However, only one, two, four, five or more lugs 21 may be present. Preferably, the same number of lugs 21 as bow 11 are present. The 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. Preferably, 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. As a result, continuous and continuous channels between the central passage opening 23 and the outside of the ring body 2 are present. Preferably, 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. For example, 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.

It can be clearly seen in FIGS. 2 and 3 that the seal 4 is preferably a ring seal. Preferably, it is resilient. In this embodiment, it consists of two circumferential sealing lips, which form an angle. In this case, 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. In Figure 3, 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.

In Figure 4, the lid 1 is shown in a view obliquely from below. Here it can be seen that 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. Preferably, the grooves 22 are dimensioned so that the line must be pressed into it and is held positively in position. For example, 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 °.

Now, if the cover 1 is slipped over the ring body 2, the line is fixed in position in the passageway 6 and they can not move in particular in their longitudinal direction. Thanks to 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 °. Thanks to 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 according to this example 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. This can be seen in FIG. 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.

Also in this example, 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 according to the invention 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.

LIST OF REFERENCE NUMBERS

Cover 22 groove

Main body 23 central passage opening

Strap 24 base

Mounting holes 25 sheath

Inlet opening or channel 26 transition region central end of the inlet opening 27 top surface

cover surface

Mark 3 insert element

Closure body 30 surface

Coat 32 coat

Transition area

Recess 4 seal

closure rib

5 fixing element

Ring body 50 plug body

Body 51 external thread

Nose 52 neck

upper surface

lower surface 6 through-channel

Claims

Anchoring device for anchoring a conduit in a skull borehole, comprising a base part (2, 3, 4, 5) and a lid (1) sealing the base part, wherein the base part has a fixing element (5) for fixing the base part in the borehole and a Through hole for the passage of the line from the borehole to an outer side of the anchoring device, wherein in the base part extending between the borehole and the outside bearing surface (30, 22) for conditioning of the line is present, characterized in that the contact surface (30, 22) in is formed curved in a constant direction, 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.

Anchoring device according to claim 1, wherein a passage channel (6) for receiving the conduit is provided, which is formed on the one hand by the contact surface 30, 22) and on the other hand by the cover (1).

Anchoring device according to claim 2, wherein the cover (1) positively closes the base part (2, 3, 4, 5) except for the formation of the through-channel.

Anchoring device according to one of claims 1 to 3, wherein the base part has at least one radially outwardly projecting lug (21) with an upper side, said upper side continuously adjoining the curved abutment surface (22) and as outer abutment surface (FIG. 210) is used for the line.

Anchoring device according to claim 4, wherein a plurality, in particular three lugs (21) are provided, which are arranged gleichabständig over the outer circumference of the base part and which are formed as turning handles for screwing the base part into the borehole.

6. anchoring device according to one of claims 1 to 5, wherein the lid (1) has an inner surface which is adapted to the contact surface of the base part and the line to the contact surface (30, 22) presses.

An anchoring device according to any one of claims 1 to 6, wherein the through-opening comprises a funnel (30), the funnel (30) tapering towards the borehole, and the inside of the funnel (30) facing a longitudinal central axis of the funnel (30) arched is formed.

8. anchoring device according to one of claims 1 to 7, wherein the cover (1) has a projecting towards the base part conical closure body (16).

9. Anchoring device according to one of claims 1 to 8, wherein the base part has at least one radially outwardly from an inner side extending groove (22) into which the line is inserted.

10. Anchoring device according to one of claims 1 to 9, wherein the fixing element (5) has an external thread (51) for fixing the base part in the borehole and between a male thread (51) and the rest of the base part a neck (52) is arranged, which is a larger Diameter than the external thread (51) and serves as a spacer between the skull and the rest of the base part.

11. Anchoring device according to one of claims 1 to 10, wherein an annular seal (4) is provided for sealingly fixing the conduit in the base part.

12. anchoring device according to one of claims 1 to 11, wherein in the passage opening a protection against migration of microorganisms and / or dirt particles is introduced.

Mooring device according to one of claims 1 to 12, wherein the lid (1) on its inside with a protection against migration of microorganisms and / or dirt particles is provided.

14. Anchoring device according to one of claims 1 to 13, wherein the cover (1) has radially outwardly projecting fastening elements (11), by means of which it can be fastened to a scalp or the skull.

15. Anchoring device for anchoring a conduit in a skull borehole, comprising a base part (2, 3, 4, 5) and a lid tightly sealing the base part (1), wherein the base part a fixing element (5) for fixing the base part in the borehole and a passage opening for the passage of the conduit out of the borehole to an outer side of the anchoring device, characterized in that the base part has at least one groove (22) extending radially from an inner side to the outside with a groove bottom and wherein this groove projects into a radially outwardly projecting groove Nose (21) merges, said nose (21) having an upper side which connects continuously to the groove bottom of the groove (22) and serves as an outer skull-inclined contact surface (210) for the line.