• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    Device for decompressive craniotomy The invention describes a device (1) for decompressive craniotomy, comprising: a first plate (2) with a first end (21) configured for its attachment to the bone flap (CO); and a telescopic element (3) having a base (31) configured for its attachment to the skull (C) and an upper end (32) configured for its attachment to a second end of the plate (22), wherein the base (31)) of the element (3) comprises: a first ball joint configured such that, when said base (31) is fixed to the skull (C), the telescopic extensible element (3) can be inclined relative to the skull (C); and a locking means configured to fix an inclination of the element (3), and wherein the upper end (32) of the element (3) comprises a second ball joint configured such that, when said upper end (32) is fixed to the plate (2), the plate (2) can be inclined in relation to the element (3). (Machine-translation by Google Translate, not legally binding)
    公开号:ES2677168A1
    申请号:ES201631723
    申请日:2016-12-30
    公开日:2018-07-30
    发明作者:Cristóbal José BLANCO ACEVEDO；Jerome MOURET；Rosa María Carolina DÍAZ PERNALETE；Jesús Adolfo LOZANO SÁNCHEZ；Juan SOLIVERA VELA；Álvaro TOLEDANO DELGADO；Juana María VIDAL MIÑANO
    申请人:Servicio Andaluz de Salud；
    IPC主号:
    专利说明:

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    DESCRIPTION
    Device for decompressive craniotomy OBJECT OF THE INVENTION
    The present invention belongs to the field of neurotirgy, and more specifically to the fixation elements used when a craniotomy is performed with the intention of being decompressive.
    The object of the present invention is a new dynamic bone fixation device that allows to establish a space between the bone flap and the brain to relieve intracranial pressure in case of cerebral edema that compromises the patient's life.
    BACKGROUND OF THE INVENTION
    A craniotomy consists essentially of the surgical opening of the skull by means of the extraction of a flap or part of bone, with or without opening of dura, previously making incision of the scalp. This flap is fixed again in its position to the rest of the skull when the operation is finished.
    The fixation of the bone flap to the rest of the skull can be carried out using different types of elements, which in some cases can be both absorbable and non-absorbable, among which are: suture threads, wires, microplates or rosettes with screws, devices self-anchoring, hydroxyapatite, etc. These traditional fixation systems are usually rigid, that is, the bone flap is fixed to the skull in a fixed and static way.
    However, there are cases in which cerebral edema occurs that can cause a dangerous increase in intracranial pressure. In these cases, the adoption of various conservative measures is required, which, if insufficient to relieve intracranial pressure, forces the bone flap to be removed again in order to increase the intracranial space to prevent cerebral herniation from occurring. and its serious consequences. Subsequently, once this period has elapsed (which can range between approximately 7 and 45 days), a second intervention will be necessary to
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    Reimplant the bone flap again. All these surgical operations imply a significant increase in human and material resources, as well as an increase in the likelihood of complications.
    To solve this problem, some fixation devices have been designed that allow a displacement of the bone flap in order to provide additional space to reduce intracranial pressure. These devices are fundamentally based on the fixation to the skull of a plate through extensible elements, for example telescopic elements. This allows the bone flap to move to relieve intracranial pressure and subsequently, once the edema is over, return to its initial position.
    US 2012/0184999 A1 describes such a device where a telescopic element is used that is fixed by means of tips or nails to the skull and bone flap.
    Document US2012 / 0165879 A1 describes another device of the same type where the telescopic element is inserted into the skull bone so that it barely protrudes from it when it is in its retracted position.
    However, despite the existence of these and other documents that describe devices for decompressive craniotomy of this type, its use has not yet been generalized because its use presents problems of indole practice.
    DESCRIPTION OF THE INVENTION
    The inventors of the present invention have identified a problem that affects all existing devices of this type and that makes them unsuitable for use in real cases. This is a problem related to the fact that a skull in its anatomical position has an appreciable curvature, while the currently known devices are designed without considering such curvature, that is, assuming that it is void or negligible. Indeed, all current devices are intended for anchoring in the skull so that the extensible element extends in a strictly perpendicular direction with respect to the surface of the skull at the anchor point. However, due to the curvatures and irregular surfaces of the skull, the line of displacement of the edge of the bone flap when it separates from the rest of the skull is not perpendicular to the skull.
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    This situation can be clearly seen in Fig. 1, where a skull (C) has been depicted in which a bone flap (CO) that is to be separated from said skull (C) has been cut vertically upwards. The edges of the bone flap (CO) also move vertically upwards following the displacement line (L1). However, the extensible elements (100) of the current fixing devices are intended to extend perpendicular to the surface of the skull (C) at the anchor point according to the travel line (L2). These two displacement lines (L1, L2) gradually separate a greater distance as the bone flap (CO) separates from the skull (C). For this reason, current devices do not work in practice as planned during design, since as the bone flap (CO) separates from the skull, tensions occur that cause deformation of various elements. This deformation causes that, once the edema is overcome, the bone flap (CO) does not return to its initial position. This generates significant inconveniences that can only be solved by a second surgical intervention.
    To solve this problem, the present invention proposes a device configured in such a way that it allows the inclination of the extensible element in relation to the point of the skull to which it is fixed. That is, the device is designed in such a way that the direction of the extensible element in relation to the skull is adapted to the direction of movement of the bone flap. This prevents the appearance of tensions during the displacement of the bone flap.
    In addition, the extensible element is configured so that the bone flap is not “floating” above the edema, a situation that happens with all other devices, but has a fixed extension position designed so that the flap is in an elevated position such that the brain never touches it. This allows to avoid increases in pressure as a result of the interaction between the flap and the brain. The clinical practice indicates that maintaining a fixed distance the bone flap could allow a better recovery of the patient and reduce the associated complications, since it allows to maintain the anatomical structures and tissues according to their physiological state.
    Another additional advantage of the present invention is that the device can be placed away from the cutting area and does not leave any fixing element under the skull, which allows for optimal reconstruction of the skull.
    The most basic configuration of the device for decompressive craniotomy according to the
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    The invention essentially comprises a first connection plate and an extensible telescopic element. Next, each of these elements is defined in greater detail:
    a) First connection plate
    It is an elongated plate that has a first end configured for fixation to the bone flap and, as explained below, a second end configured for fixation to an extensible telescopic element.
    This first plate can comprise a step in the longitudinal direction so that, when fixed to the patient's skull, the second end is located at a higher height than the first end. In this context, height is defined as the distance perpendicular to the surface of the skull or bone flap. This step is intended to provide space for the extensible telescopic element that will be fixed to the second end of the plate. For example, the height of this step can be between 5 and 10 mm. In a preferred embodiment of the invention shown in the attached figures, the step is formed by elbows at 90 °. However, it is possible to implement the step without sharp edges through smooth direction changes.
    Alternatively, the first connection plate could be flat and made of a material that can be folded manually. In this way, the surgeon himself could bend the plate to generate a step or change of direction according to the particular needs of each particular application.
    The first end of the first connection plate to the bone flap can be fixed in any way known in the art, such as through screws or the like. In addition, the first connection plate has a sufficient length to allow its fixation to the bone flap at a sufficient distance from the cutting area, thus avoiding the inconveniences associated with it.
    b) Extendable telescopic element
    The telescopic element has a retracted position and an extended position, and comprises a base configured for fixing to the skull and an upper end
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    configured for fixing to the second end of the elongated plate.
    In this document, the term "folded configuration" or "stowed position" refers to a telescopic element configuration where it adopts the minimum possible length corresponding to a situation in which the skull and bone flap are at the same level. The specific length of the stowed position will depend on the step height of the first connection plate. Therefore, in the retracted configuration the telescopic element can measure approximately between 5 mm and 10 mm.
    In this document, the term "extended configuration" or "extended position" refers to a configuration of the telescopic element where it adopts a length corresponding to a situation in which the bone flap is at a height greater than the skull, this length being greater than that corresponding to the retracted configuration. The extended position is sufficiently separated from the retracted position to prevent the bone flap from compressing the edematized brain. In this way, sufficient space is provided to prevent intracranial pressure from producing deleterious effects on cerebral parenchyma, allowing the period of edema and resorption thereof to be performed without any external compression.
    The telescopic element is preferably designed so that, starting from the stowed position, it can be extended to the extended position through a pulsation of its upper end. This is achieved using an elastic element, such as a spring or a spring, as will be described in more detail later in this document.
    In a preferred embodiment of the invention, the extensible telescopic element is also configured to return from the extended position to the retracted position in response to the application of a longitudinal force on its upper end, by means of a push on the second end of the first plate. .
    As will be described in more detail later in this document, this will allow the bone flap to return to its original position once the patient has overcome the edema. For this, the medical professional will only have to press from the outside of the patient's scalp on the upper end of the
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    telescopic element (and guide the descent with your hands if necessary).
    With the purpose of allowing the medical professional to locate the position of the upper end of the telescopic element, the second end of the first connection plate may also comprise a recognizable relief from the outside of the patient's scalp. For example, the second end of the first connection plate can be configured as a ball, cube, or any other shape that can be recognized through a layer of skin such as the scalp between 0.5 and 1 cm thick.
    As for the base of the telescopic element, it comprises a first ballpoint configured so that, when said base is fixed to the skull, the extensible telescopic element can be inclined relative to the skull. Additionally, the upper end of the extensible telescopic element comprises a second ballhead configured such that, when said upper end is fixed to the first connection plate, the first connection plate can be inclined relative to the extensible telescopic element. The first label allows the extension direction of the telescopic element to align with the direction of travel of the bone flap, avoiding the problems of prior art devices related to the strictly perpendicular extension of said devices. The second label is necessary to allow the first connection plate, and therefore also the bone flap, to maintain its relative orientation despite the inclination of the extensible telescopic element. The connection between the upper end of the telescopic element and the first connection plate is separable, to facilitate the installation and uninstallation of the device.
    The base of the extensible telescopic element further comprises a locking means configured to fix an inclination of the extensible telescopic element. Indeed, the fact that the extensible telescopic element can be tilted freely in relation to the patient's skull is essential for the movement of the bone flap from the initial position to the elevated position during the intervention, and back from the elevated position to the position Initial once the edema is over. However, the free inclination of the telescopic element during the time that the bone flap is in its elevated position, for example several weeks, can be a problem because it is not recommended that the bone flap travel during that interval. Note that in a procedure
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    From decompressive craniotomy, the bone flap will be held using various devices such as that described in the present invention. If the telescopic extensible element of each of them is free to lean in any direction, when the bone flap is in its elevated position, it will be “loose”, that is, it will move freely. To avoid this, the locking means allows the inclination of each telescopic element to be fixed once the flap is in the raised position. This procedure will be described in more detail later in this document.
    This blocking means can be implemented in any way known in the art provided that it allows to block and unlock at will the ability of the base of the extensible telescopic element to freely lean in any direction. By way of example, reference can be made to a blocking means described in US Patent 6,267,769 entitled "Trajectory guide method and apparatus for use in magnetic resonance and computerized tomographic scanners". Next, the operation of this blocking means will be briefly described with reference to Fig. 2, which essentially corresponds to Fig. 3 of the mentioned patent.
    Fig. 2 shows a perspective view of the path guide 200 comprising a base 210, a mobile member 220, a locking member 230 and a guide member 240. The guide member 240 is fixed to the mobile member 220. The base 210 includes a cylindrical portion 212 and a flange 214 for fixation to the patient's skull. The base 210 also includes a hemispherical seat 218 in which the mobile member 220 is housed, which is a ball or sphere that can rotate inside said seat 218 and thereby modify the inclination of the guide member 240. Note that, in the context of the present invention, said ball or sphere corresponds to the first ball. The locking member 230 has a cylindrical bottom portion 232 provided with internal threads. These internal threads are configured to engage external threads in the unit 210 such that a portion of the locking member 230 is coupled to the movable member 220 and prevents it from rotating. That is, a rotation of the blocking member 230 relative to the base 210 causes the inclination of the guide member 240 to be fixed.
    Therefore, the blocking means of the invention can be implemented in accordance with this configuration comprising a lower skull fixing member.
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    provided with a hemispherical orifice, a sphere housed in said hemispherical orifice to which a telescopic rod is connected, and an upper locking member with a cylindrical lower orifice configured to be threadedly coupled to the lower member, where the coupling of the upper member to the member lower causes the immobilization of the sphere and therefore the fixation of the tilt of the telescopic rod.
    A decompressive craniotomy procedure using devices of this type each formed by a telescopic element and a first connection plate would summarize the following (each step will be performed for each of the devices used):
    - First, the patient's scalp is opened.
    - Then, the first end of the first connection plate is fixed to what will be the bone flap and the base of the telescopic element extensible to the skull.
    - Then, the first connection plate is rotated around its first end until it is placed in a position where it does not obstruct the cutting line.
    - Next, the skull is cut using a suitable tool.
    - Then, the first connection plate is rotated again and its second end is fixed to the upper end of the extensible telescopic element.
    - Next, the bone flap is pulled in accordance with the most appropriate direction, thus causing the extension of the telescopic elements from their retracted position to their extended position. During this operation, the inclination of the telescopic elements is not fixed, so it is possible to lift the bone flap without problems.
    - Once the bone flap is in the elevated position and the telescopic elements in the extended position, it is pressed on the upper end of the telescopic element to lock it in its extended position and with the current inclination. For this, the telescopic element is designed in such a way that a pulsation thereof simultaneously causes the rotation of the upper portion of its base.
    - Then, the patient's scalp is closed again with the device of the invention inside.
    - During the following days, the pressure generated by the edema itself can expand without causing compromise of the internal structures. The extended position of the telescopic elements is selected so that the brain has enough space to expand without touching the flap.
    - Finally, once the patient has overcome edema and brain volume has
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    returned to normal, click on the upper end of the telescopic extendable element to unlock both its retraction capacity and its inclination. This manipulation is done from outside the scalp that at that time is already closed. The telescopic element is then returned to its retracted position without any restriction in terms of inclination. The surgeon's ability causes the bone flap to return exactly to its original position.
    - Press again on the upper end of the telescopic extendable element to lock it again in its stowed position.
    - The telescopic element and the plate remain permanently fixed to the patient's skull to prevent the bone flap from moving.
    Therefore, in this embodiment of the invention the device, which is formed by the telescopic element and the plate, remains permanently under the patient's scalp attached to the patient's skull to ensure that the flap remains in its position so stable. On certain occasions, this may be uncomfortable for the patient, either for aesthetic reasons or for practical reasons related to the permanent presence of a bulge in his skull.
    In view of this, in an alternative preferred embodiment of the invention, the first plate and the telescopic element may be made of a bioabsorbable material. By way of example, a material consisting of 82% poly-L-lactic acid and 18% polyglycolic acid can be mentioned, which is reabsorbable in an approximate period of 1.2 years. Thanks to this, the device of the invention would end up being absorbed by the patient's tissues.
    According to another preferred embodiment of the invention, the device further comprises a second flat elongated plate having a first end configured for fixation to the bone flap and a second end configured for fixation to the skull. For example, both ends may have a suitable hole for screws or the like. This second plate can be installed essentially parallel to the first plate, and will serve as a definitive union in case it is necessary to remove the first plate and the telescopic element, or in the case where the first plate and the telescopic element are made of a resorbable material.
    The decompressive craniotomy procedure using this preferred embodiment of the device would be essentially identical to that described above except that, once
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    The bone flap has returned to its original position after overcoming the edema, the fixation of this second plate fixed the bone flap and the skull would be carried out. This can be done at the end of the procedure through a second intervention that would serve to fix this second plate and, in case they were not reabsorbable, to remove the first plate and the telescopic element.
    In a particularly preferred embodiment of the invention, the device also comprises a flat base part provided with an articular eminence and configured for fixing to the skull, the second end of the second plate being configured for anchoring / engaging the eminence only through of the application of a pressure.
    In this document, the term "articular eminence" refers to a protuberance or projection provided in a manner that allows fixing to the second end of the second plate. For example, the second end of the second plate may have a bore of a diameter just the same or very slightly less than that of the eminence, so that if a strong pressure is exerted on the second end of the second plate against the eminence it is possible to introduce said pivot through the hole.
    The decompressive craniotomy procedure using this preferred embodiment of the device would be essentially identical to that described above except that, once the bone flap has returned to its original position after overcoming the edema, the fixation of this second fixed plate would be carried out. bone flap and skull. This fixation could be carried out in a second intervention that would also serve to remove the first plate and the telescopic element in case they were not reabsorbable. Alternatively, if the first plate and the telescopic element were resorbable, the fixation of the second plate could be carried out through the patient's scalp without the need for a second intervention. It would be enough to place the hole of the second end of the second plate above the articular eminence and push through the scalp until fixation occurs.
    BRIEF DESCRIPTION OF THE FIGURES
    Fig. 1 shows a diagram of the operation of the prior art devices.
    Fig. 2 shows a perspective view of an example of a prior art blocking means that can be used in the present invention.
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    Fig. 3 shows a perspective view of an extensible telescopic element according to the present invention.
    Fig. 4 shows a perspective view of a first plate according to the present invention.
    Fig. 5 shows a first configuration of the device of the invention with the telescopic element extensible in a retracted position.
    Fig. 6 shows the first configuration of the device of the invention with the telescopic element extensible in an extended position.
    Fig. 7 shows a perspective view of a second plate according to the present invention.
    Fig. 8 shows a perspective view of a piece provided with an articular eminence according to the present invention.
    Fig. 9 shows a second especially preferred configuration of the device of the invention with the telescopic element extensible in a retracted position and the second plate hooked to the articular eminence of the base piece.
    Fig. 10 shows the second especially preferred configuration of the device of the invention with the telescopic element extensible in an extended position and the second plate not fixed to the articular eminence of the base piece.
    Figs. 11a-11h show the main steps of a decompressive craniotomy procedure using the second especially preferred configuration of the present invention.
    Fig. 12 shows an example of realization of the telescopic element of the device of the invention.
    PREFERRED EMBODIMENT OF THE INVENTION
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    The present invention is described below with reference to the attached figures in which they have represented the main parts that compose it.
    First configuration
    A first configuration of the device of the invention consists only of an extensible telescopic element (3) and a first plate (2). Next, each of these elements is described and its mode of operation is briefly explained.
    Fig. 3 shows an example of a telescopic element (3) according to the present invention. As mentioned previously, this telescopic element (3) has a base (31) configured for fixing to the skull (C) by means of holes designed for the passage of screws or the like. The base (31) has a label (it is hidden in the figure) to which the telescopic rod (33) is attached so that said telescopic rod (33) can freely lean in any direction of space. The base (31) of the telescopic element (3) also includes a locking means that allows the telescopic rod (33) to be immobilized at any inclination. This locking means is activated by rotating the upper part of the base body (31), as described in US Patent 6,267,769. That is, it is possible to tilt the telescopic rod (33) in any direction until the desired inclination and orientation is achieved and, at that time, simply rotate the upper part of the base body (31) relative to the rod (33) or vice versa, for example by manually acting on the triangular cross-section flange, to fix the telescopic rod (33) in that inclination and orientation. Alternatively, it is possible to configure the telescopic element (3) so that the application of a pressure on the telescopic rod (33) causes the blocking of both its inclination and its extension / retraction capacity, as will be described later in this document. .
    The telescopic element (3) also has an upper end (32) provided with a second label that will allow the first plate (2) to pivot with respect thereto. This connection between the first connection plate (2) and the telescopic element (3) will be detachable, that is, it can be manually engaged and disengaged. In this example, a hemispherical cavity is disposed at the second end (22) of the first connection plate which is complementary to the upper end label (32) of the telescopic element (3). This degree of freedom in fixing the first plate (2) to the upper end (32) of the telescopic element (3) is necessary so that tensions do not occur in the union of the first plate (2) to the bone flap (CO) as a result of variations in
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    inclination of the telescopic rod (33).
    Fig. 12 shows a schematic cross section of an example of telescopic element (3) according to the present invention showing the extension / retraction mechanism. This telescopic element (3) has a rod (33) formed by a lower section (33a) that slides longitudinally inside an upper section (33b), where a spring (33c) drives the upper section (33b) longitudinally towards the extended position. The upper section (33b) also has a central piece (33d) that protrudes longitudinally downwards, and which can be essentially rounded or semi-spherical in shape. The lower section (33b), in turn, has several tabs (33e) that can have an annular shape and are located in the displacement path of the center piece (33d). These tabs (33e) have a certain flexibility, so that for the center piece (33d) to pass between them a certain threshold force must be exceeded. Thanks to this configuration, various extension positions are obtained, in this case two, between which it is simply passed through the application of a pressure on the upper end (32) of the telescopic element (3).
    In addition, the upper section (33b) is coupled to the lower section (33a) so that the relative longitudinal displacement between one and the other also implies a relative rotation. This can be achieved, for example, by being coupled to each other by means of a thread (not shown in Fig. 12). Thanks to this, a pulsation on the upper end (32) of the telescopic element (3) also causes a rotation of the lower section (33a) of the rod. Since the rotation of the upper part of the body of the base (31) to which the lower section is fixed (33a) causes the rod tilt to block (33), this mechanism makes the upper end pulsation (32) ) of the telescopic element (3) alternatively causes the locking or unlocking of the inclination of the rod (33).
    In short, this configuration of the telescopic element (3) allows each pulse at its upper end (32) respectively to block or unblock both the inclination capacity and the extension / retraction capacity of the device of the invention.
    Fig. 4 shows an example of the first connection plate (2). This first connection plate (2) has a first end (21) configured for fixing to the bone flap (CO) and a second end (22) configured for fixing to the upper end (32) of the extensible telescopic element (3). More specifically, the first end (21) has a suitable hole for the insertion of screws or the like, while the second end (22) has a
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    hemispherical cavity complementary to the upper end label (32) of the telescopic element (3). In addition, the second end (22) of the first connection plate (2) has a relief (23), in this particular case a ball, which allows the surgeon to recognize its position through the patient's scalp.
    In this example, the first plate (2) has a necessary step so that there is sufficient space for the telescopic element (3) fixed to the patient's skull (C). Although this step has been represented here through two 90 ° elbows, it would be possible to implement it in other equivalent but less aggressive ways, such as by rounded shapes. In any case, the important thing is that the second end (22) is at a height greater than the first end (21) when the plate (2) is fixed to the patient's skull (C), so that space is left sufficient for the telescopic element (3) extensible.
    Fig. 5 shows the device (1) according to the first configuration set in a state in which the bone flap (CO) has not yet risen above the level of the skull (C), for example at the beginning of the procedure just after the realization of the cut, or at the end of the procedure once the edema has remitted and the bone flap (CO) has been returned to its initial position. It can be seen how the first connection plate (2) is fixed through its first end (21) to the bone flap (CO), for example by means of a screw, and the extensible telescopic element (3) is fixed to the skull (C) through its base (31), also by screws. The second end (22) of the first connection plate (2) is coupled to the label of the upper end (32) of the telescopic rod (33). The telescopic rod (33) is in a retracted position, that is, of minimum length.
    Fig. 6 shows the device (1) according to the first configuration set in a state in which the bone flap (CO) has been lifted by the surgeon above the level of the rest of the skull (C) a sufficient distance to leave enough space so that the edema swells without touching the flap (CO). The telescopic rod (33) is in an extended position.
    Second configuration
    The second configuration of the device (1) of the invention includes the two components mentioned above, first connection plate (2) and extensible telescopic element (3), and also a second elongated flat plate (4) and a base part (5) flat with
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    an eminence (51) articulate.
    The second plate (4), shown in Fig. 7, is a plate designed as definitive fixation in cases where this is necessary, and its complete fixation to skull (C) and bone flap (CO) is only Performs during a second surgery once the edema has subsided and both are aligned at the same height. For this reason, it has a flat shape with a first end (41) configured for fixation to the bone flap (CO), for example through a screw hole or the like, and a second end (42) configured for fixing to the skull (C), for example also through a hole that can be for a conventional screw, or for fixing to an articular eminence (51).
    The base plate (5), shown in Fig. 8, is a small size plate designed only to support the eminence (51) that allows the second end (42) of the second plate (4) to be coupled to the skull (C). The base plate (5) can be fixed to the patient's skull (C) through screw holes or the like. As for the shape of the eminence (51), it will be semi-spherical, conical with the rounded vertex, or similar, and will normally be provided with a foot of a diameter smaller than the maximum diameter of said eminence (51). In this way, it is possible to introduce said eminence (51) into the hole of the second end (42) of the second plate (4) only through the application of a pressure on said second end (42) of the second plate (4). ). This can be done from the outside of the patient's scalp, so that the definitive coupling / anchoring between the eminence (51) and the second end (42) takes place without the need for a second surgical intervention.
    Fig. 9 shows an example of the second configuration of the device (1) of the invention in a position in which the bone flap (CO) and the skull (C) are essentially aligned at the same height, either at the beginning of the procedure, or at the end once the edema has subsided and the surgeon has manually lowered the bone flap (CO) from outside the scalp. In addition to the first (2) connection plate and the telescopic element (3) described earlier in this document, the second plate (4) already attached to the bone flap (CO) through a screw and to the skull (C) through the eminence (51) of the base piece (5). This base piece (5) is shown already fixed to the patient's skull (C) thanks to four screws.
    Fig. 10 shows the device (1) according to the second configuration in a position in which the bone flap (CO) has been lifted by the surgeon above the level of the rest of the
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    skull (C) a sufficient distance to leave enough space for the edema to swell without touching the flap (CO). It can be seen how the first end (41) of the second plate (4) is fixed to the bone flap (CO), while the second end (42) is cantilevered in such a way that it protrudes very little from the bone flap (CO). When the bone flap (CO) descends, the orifice of the second end (42) will be aligned with the eminence (51), thus allowing the medical professional to simply fix it through a pressure from the outside through the scalp.
    Example of use of the device according to the second configuration
    Fig. 11a: The patient has an open scalp and an exposed skull. The doctor draws on the skull (C) the cutting area (in dashed lines) with a marker.
    Fig. 11b: A plurality (usually three) of devices (1) according to the invention are installed around the cutting area. For each of them, the following tasks are performed:
    - The base (31) of the extensible element (3) is fixed firmly to the skull (C), for example by means of several screws.
    - The first end (21) of the first plate (2) of connection to the future bone flap (CO) is fixed, for example by means of a screw. This fixing is done without tightening, so that the first connection plate (2) can rotate around the screw. The second end (22) of the first plate (2) is connected to the upper end (32) of the telescopic rod (33).
    - The base piece (5) with its articular eminence (51) is fixed firmly to the skull (C), for example through several screws.
    - The first end (41) of the second plate (4) is fixed to the future bone flap (CO), for example by means of a screw. This fixing is done without tightening, so that the second plate (4) can rotate around the screw. The second end (42) of the second plate (4) is not fixed to the articular eminence (51).
    Fig. 11c: In this step the skull (C) is cut from the patient that will lead to the bone flap (CO). Therefore, it is necessary to separate the different elements of the path that the cutting saw (S) should follow.
    - The second end (22) of the first connection plate (2) of the upper end (32) of the telescopic rod (33) is disengaged. A “CLICK” is heard when the pressure joint separates.
    - The first connection plate (2) is rotated around the future fixing point
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    bone flap (CO).
    - The second plate (4) is rotated around its fixation point to the bone flap (4) at its first end (41).
    Once these actions have been carried out, the cutting is carried out by means of the saw (S).
    Fig. 11d: In this step there is already a bone flap (CO) completely separated from the rest of the skull (C). Then the different parts that make up the device (1) are connected.
    - The rotation of the first connection plate (2) previously made is reversed and the second end (22) of the plate (2) is coupled to the upper end ball (32) of the telescopic rod (33). The coupling of the snap joint produces a "CLICK".
    - It is fixed by tightening the fixation of the first end (21) of the first connection plate (2) to the bone flap (CO), so that said first connection plate (2) can no longer rotate around its first end (21 ).
    - The rotation of the second plate (4) previously made is reversed so that the hole of its second end (42) is just above the eminence (5), without being caught.
    - The first end (41) of the second plate (4) connecting to the bone flap (CO) is firmly fixed so that the second plate (4) cannot rotate more around its first end (41).
    Fig. 11e. Once the different parts that constitute the device (1) of the invention are connected, the bone flap (CO) is lifted to provide sufficient space for the patient's brain. During this procedure, the telescopic element (3) is arranged so that the telescopic rod (33) is rotated around the label arranged in the base (31). Thanks to this, the doctor lifts with his hands the bone flap (CO) according to the direction he considers appropriate and the directions of each of the telescopic rods (33) of the different devices (1) fixed to the bone flap (CO) are Orient as necessary. Once the bone flap (CO) has reached the required height reached by the upper end (32), it is pressed on the ball (23) to block both the inclination and the length of the telescopic rod (33). This is done for each of the devices (1) used. The second ends (42) of the respective second plates (4) are cantilevered. Finally, the patient's scalp is closed.
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    Fig. 11f: A few weeks later the procedure of devolution of the bone flap (CO) to the initial position is carried out. To do this, the patient's scalp is first palpated to look for the ball (23) from the second end (22) of the first connection plate (2). Once located, it is pressed on the ball (23) to unlock both the inclination and the length of the telescopic rod (33). A sound similar to a "CLICK" indicates that the unlocking has occurred. This step is performed for each of the devices (1) used.
    Fig. 11g: Once all the devices (1) are unlocked, the bone flap (CO) is carefully guided back to its initial position. For this, the surgeon palpates on the scalp until the bone flap (CO) is found and accompanies its descent, which will be done slowly since the multiple “floors” of the extensible rod (33) of each device (1) slide little to Little among them. The surgeon will feel a slight blow when the second end (42) of the second plate (4) and the eminence (51) of the base piece (5) of each of the devices (1) are touched. The eminence (51) is then introduced for each device (1) into the hole of the second end (42) of the second plate (4). To do this, the surgeon only has to exert pressure on said second end (42). A “CLICK” type sound indicates to the surgeon that the coupling has occurred. This process is carried out for each device (1) and the bone flap is perfectly placed in its place of origin. The ball (23) of the second end (22) of the first connection plate (2) can be pressed again to block the direction and length of the telescopic rod (33). Note that this last operation is not indispensable because the hook at the level of the eminences (51) already immobilizes everything.
    Fig. 11h Allow sufficient time to allow the first plate (2) and the telescopic element (3) to be reabsorbed by the surrounding tissues. Alternatively, a second intervention is performed to open the scalp and remove both elements. This second intervention would be of relatively little importance, since the skull (C) and the bone flap (CO) would have already completely welded. In Fig. 11h the final state in which the plate (4) is installed as a final fixation to offer support and safety to prevent the mobility of the bone flap (CO) is shown.
    权利要求:
    Claims (6)
    [1]
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    1. Device (1) for decompressive craniotomy to a patient, comprising
    - a first elongated connection plate (2) having a first end (21) configured for fixation to the bone flap (CO); Y
    - an extensible telescopic element (3) having a retracted position and an extended position, comprising a base (31) configured for fixing to the skull (C) and an upper end (32) configured for fixing to a second end ( 22) of the connection plate (2),
    characterized by:
    - the base (31) of the extensible telescopic element (3) comprises: a first ballhead configured so that, when said base (31) is fixed to the skull (C), the extensible telescopic element (3) can be inclined relative to the skull (C); and a blocking means configured to fix an inclination of the telescopic element (3) extensible, and
    - the upper end (32) of the extensible telescopic element (3) comprises: a second ballhead configured so that, when said upper end (32) is fixed to the first connecting plate (2), the first plate (2) of connection can be tilted in relation to the extensible telescopic element (3).
    [2]
    2. Device (1) according to revindication 1, where the second end (22) of the first connection plate (2) comprises a relief (23) recognizable from the outside of the patient's scalp.
    [3]
    3. Device (1) according to any of the preceding claims, wherein the first plate (2) comprises a step in the longitudinal direction so that, when the plate (2) is fixed to the patient's skull (C), the second end (22) is located at a higher height than the first end (21).
    [4]
    4. Device (1) according to any of the preceding claims, wherein the first plate (2) and the telescopic element (3) are made of a bioabsorbable material.
    [5]
    5. Device (1) according to any of the preceding claims, which further comprises a second flat elongated plate (4) having a first end (41) configured for fixation to the bone flap (CO) and a second end (42 ) configured for skull fixation (C)
    [6]
    6. Device (1) according to claim 5, further comprising one comprising a flat base part (5) provided with an articular eminence (51) and configured for fixing to the skull (C), the second end being configured ( 42) of the second plate (2) for fixing to the eminence (51) only through the application of a pressure.
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    同族专利:
    公开号 | 公开日
    ES2677168B1|2019-05-07|
    WO2018122441A1|2018-07-05|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    WO1997012568A1|1995-10-02|1997-04-10|Remmler Daniel J|Implantable apparatus, matrix and method for correction of craniofacial bone deformities|
    US6267769B1|1997-05-15|2001-07-31|Regents Of The Universitiy Of Minnesota|Trajectory guide method and apparatus for use in magnetic resonance and computerized tomographic scanners|
    US8206425B2|2009-07-31|2012-06-26|Neurovention, LLC|Cranial fixation device|
    US9603626B2|2009-09-27|2017-03-28|Rohit Khanna|Telescopic cranial bone screw|
    CA2821705C|2010-12-13|2018-01-16|Rohit Khanna|A device and method for performing a decompressive craniotomy|
    ES2527701B1|2013-06-27|2016-01-15|Servicio Andaluz De Salud|Bone fixation device|
    WO2015187123A1|2014-06-02|2015-12-10|Albany Medical College|Dynamic decompressive craniotomy fixation devices and related methods|
    法律状态:
    2018-07-30| BA2A| Patent application published|Ref document number: 2677168 Country of ref document: ES Kind code of ref document: A1 Effective date: 20180730 |
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    优先权:
    申请号 | 申请日 | 专利标题
    ES201631723A|ES2677168B1|2016-12-30|2016-12-30|Device for decompressive craniotomy|ES201631723A| ES2677168B1|2016-12-30|2016-12-30|Device for decompressive craniotomy|
    PCT/ES2017/070867| WO2018122441A1|2016-12-30|2017-12-29|Device for decompressive craniotomy|
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