Intrabody guide component

Abstract

The invention relates to an intracorporeal guide component (1) for guiding a line belonging to a medical device inside a living organism. The guide component (1) has a body (2) with a line channel (3) for receiving and guiding the line. To more easily and with less trauma to tissue, the body (2) according to the invention has around its periphery one or more contact surfaces (4, 4b) designed for interlocking and / or frictional contact with the organism's bone structure. For example, the guide component (1) can be clamped between two costal arches of the organism as an intercostal guide component (1) to firmly hold and guide a line leading to the organism's heart.

Description

Technical Field

[0001] The present invention relates to an in-vivo guide component for guiding a line of a medical device inside a living being. In this specification, the guide component has a substrate with a line channel for receiving and guiding a line.

Background Art

[0002] This kind of guide component is used to guide, hold, and fix the cables, hoses, tubes, or other lines of medical devices located inside the body of a living being. For example, some implanted medical devices generally require a permanent power source that is available outside the body and is constantly worn on the body.

[0003] As a specific example, here let's describe an implanted artificial heart system. The connection between the artificial heart and the external control unit / power source, also called a drive line, starts from the control unit and is routed through the skin into the body of the living being. The drive line generally houses a power line and a data line or a control line for, for example, the exchange of sensor data and measurement data or the exchange of control commands.

[0004] The guide component is provided especially for percutaneous lines. Such lines are routed through the skin of the living being. In such use, it is a condition that the exit point of the line is surrounded by the skin so that the skin can adhere to the line and preferably also to the guide component, forming an infection barrier.

[0005] Manufacturers generally select line surfaces that promote adhesion to the skin and thus form a tight seal. However, for this purpose, there should be no tensile stress on the line, because if the line moves, it will not be able to adhere to the skin. The line may be fixed on the skin using, for example, plastic feathers fixed to a bandage. It should be noted that, in principle, the passage of the line through the muscle and / or subcutaneous area is particularly prone to infection.

[0006] U.S. Patent No. 10,105,537 B2 discloses a cable holder for a pacemaker cable. The holder is fixed, for example, by screwing or suturing in the intercostal region of a living being, i.e., within or on the muscle tissue between two ribs. The purpose of the holder is to prevent unwanted position changes of the pacemaker cable and to electrically insulate the pacemaker cable from the muscle through which the cable is routed.

[0007] U.S. Patent Application Publication No. 2006 / 0025826 A1 discloses a subcutaneous implantable cardioverter-defibrillator having a telescopic line. The device has a housing with a guide channel in which the line is displaceably arranged to allow for length compensation and more free positioning of the housing. To enhance wearing comfort, the housing can be arranged intercostally, parallel to the patient's ribs, between the ribs. For this purpose, the housing may have an elongated and curved design.

[0008] U.S. Patent Application Publication No. 2018 / 0272122 A1 discloses an implantable medical device that can be fastened to the intercostal muscle tissue. For this purpose, the device has one or more elongated anchor structures that are inserted into the muscle tissue and thereby fix the device in its predetermined intercostal position. The device may have a convex shape so that it can be arranged flush on the muscle tissue.

[0009] U.S. Patent No. 2004 / 215303A1 describes contacts for electrical connection of a biomedical implantable line. These are biocompatible and electrically conductive contact connections that surround, for example, in a ring shape, the conductor to be connected.

[0010] U.S. Patent No. 2011 / 009933A1 relates to an implantable electrical stimulation system for an implantable device having a guide channel for one or more electrode lines.

[0011] U.S. Patent No. 2011 / 004286A1 proposes an implantable cardiac device having a line. For example, a cardiac device designed as a pulse generator or defibrillator is placed on the patient's chest wall or abdominal wall, and the line is routed to the heart. To strengthen or relieve the tensile stress on the line, a rigid line channel having, for example, four openings for conductor wires is provided in several portions.

Prior Art Documents

Patent Documents

[0012]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Patent Document 6

Summary of the Invention

Problems to be Solved by the Invention

[0013] In light of this background, the problem to be solved by the invention is to make available an improved guide component that can be more easily and gently fixed inside the body of an organism. The guide component should be particularly suitable for guiding percutaneous lines as well.

Means for Solving the Problem

[0014] The problem is solved by a guide component of the problem type, in which the base body of the guide component has one or more contact surfaces designed for form-fit engagement and / or force-fit engagement with the bone structure of the organism around it.

[0015] Form-fit engagement is understood to mean a connection involving interlocking of the guide component and the bone structure such that the guide component and the bone structure do not separate from each other because of their shapes. Here, the guide component and the bone structure are, so to speak, "blocking each other's way" so that they support each other.

[0016] In the case of force-fit engagement, relative displacement between the guide component and the bone structure is prevented due to the static friction acting between the two components. The guide component and the bone structure are adhesively bonded to each other by friction fit as long as the static friction is not overcome by an external force.

[0017] Thus, the base body can be held on the bone structure, on the one hand, due to its shape, for example, a shape in which some parts exhibit a contour or an undercut opposite to that of the bone structure, and on the other hand, due to its surface, for example, a surface having a high coefficient of static friction. Of course, a combination of form-fit engagement and force-fit engagement is also conceivable.

[0018] Shape fitting can be made available, for example, by at least a partially curved shape of a guide component that cooperates with the curvature of a rib. Corresponding notches on the cranial and caudal surfaces of the guide component can improve the shape fitting.

[0019] According to the invention, a contact surface that occupies at least a part of the surface of the substrate is designed for shape fitting engagement and / or force fitting engagement with a bone structure. The contact surface may further be peripherally provided around the substrate or may be divided into a plurality of individual contact surfaces spaced apart from each other. Thus, it is not essential that the entire substrate is designed to bear on the bone structure.

[0020] The bone structure is understood to mean an organ of a living being that is pressure-resistant and tension-resistant and is part of the skeleton of the living being. This may be a single bone, or a plurality of bones, or a bone connection such as a joint. The bone structure is preferably a rib structure, for example the rib structure of the thoracic cage of a living being, and the rib structure may be formed by a single rib or may be formed by a plurality of ribs, specifically two adjacent ribs.

[0021] The line in question is, in principle, further a line that is rigid but specifically flexible or at least partially flexible, i.e., a compliant and / or elastic connection channel suitable for transporting a medium or designed as a power line and / or a data line. In the case of a power line or a data line, these may accommodate an electrical conductor such as a metal wire, but may equally well accommodate an optical conductor such as an optical fiber. The medium transport line is, for example, a hose, a tube, or a catheter that transports a gas such as air and gas mixtures or a liquid such as a body fluid or a medical solution. Furthermore, a plurality of conductors may be provided in the line surrounding them, for example, a cable or a hose may have a plurality of electrical lines such as power lines and data lines routed inside it.

[0022] The line is generally connected to a medical device that can be designed as a control unit of an artificial heart system, as a dialysis machine, or as a ventilator. In principle, a wide variety of medical devices that can be connected to a living being's internal organs via the line can be considered. These do not necessarily have to be devices that are permanently attached to the living being's body, but can also be devices that are simply attached to the line periodically or irregularly. However, it is desirable that the line itself be permanently routed inside the relevant living being and not merely temporary, and thus the guide component is also intended for long-term use.

[0023] In this application, a living being is essentially understood to mean a living being as a human or an animal for which medical treatment using a medical device of the type in question is feasible.

[0024] The guide component according to the invention has a substrate that defines the substantial three-dimensional extent and shape of the guide component. The substrate can in principle have a regular or symmetric basic shape such as a sphere, a cuboid, a cylinder, a cube, or a truncated pyramid. However, irregular, polygonal, and asymmetric basic shapes are also conceivable. In one embodiment of the invention, the guide component has a trapezoidal base area, and it is desirable that the narrower side of the trapezoid be oriented dorsally when the guide component is in the installed state. Finally, in particular, the shape and extent of the substrate are based on the geometric characteristics of the site that is the target location inside the body, and this is especially true with regard to the contact portion between the substrate provided by the invention and the bone structure of the living being.

[0025] Regardless of the basic shape of the substrate, the substrate has a line channel for receiving and guiding a line. In the simplest case, such a line channel can be designed as a through-hole that penetrates the substrate such that a line channel with a circular guide cross-section is formed. Of course, line channels with other guide cross-sections are also conceivable, for example, line channels with a rectangular or semi-circular guide cross-section. The line channel preferably passes through the interior of the substrate in order to ensure a high degree of guiding stability. However, in other embodiments, it is also conceivable to arrange the line channel around the substrate, for example, in the form of a suitable groove or guide eyelet that prevents the line from loosening from the substrate.

[0026] It should be noted that the translations "or a" or "a" of the original text's articles "a" or "an" in this specification should not be construed as meaning only one. Thus, in principle, a plurality of line channels can also be provided in the substrate or the guide component in order to be able to hold and fix a plurality of different lines. Specifically, for example, line channels of a plurality of different designs having different diameters may be provided.

[0027] Numerous primary forming and reforming manufacturing methods can be used to manufacture the substrate. For example, the substrate can be manufactured particularly simply by a casting method or a press forming method, or it can be manufactured with a high degree of individuality by an additive manufacturing method (for example, a 3D printing method) or a molding method. In order to manufacture a guide component having the desired geometric requirements with the minimum possible number of manufacturing steps, a structure that complements the basic shape, for example, a line channel, can be reflected in the manufacturing method in advance.

[0028] Using the guide component according to the invention, for the first time it becomes possible to quickly and easily fix, for example clamp, to a desired site within a living body by engaging the guide component with one or more bone structures. Therefore, no additional connection means, specifically screws or surgical threads, are required to attach the guide component. In addition, since the guide component does not necessarily have to be screwed or sutured into tissue, skin, and bone, trauma to tissue, skin, and bone is avoided or at least reduced. Therefore, in principle, the guide component can be implanted in a minimally invasive manner. In addition, since the guide component engaging the bone structure is supported on a relatively rigid and immovable bone structure, it is arranged in a more stable manner, specifically in a more stable position.

[0029] Thanks to being fixed using a force fit engagement and / or a form fit engagement, the guide component is of a relatively small size, and thus only a small tissue incision is required for implanting the guide component compared to prior art solutions.

[0030] The guide component can be positioned and firmly held directly under the skin by bearing on the bone structure using a form fit engagement and / or a force fit engagement, and is thus particularly suitable for guiding percutaneous lines.

[0031] In one particularly advantageous embodiment, the base body has at least two contact surfaces extending on opposite sides thereof and designed to bear on the bone structure of a living being using form-fitting and / or force-fitting engagement. Thus, the two contact surfaces are specifically spaced apart from each other in such a way that the contact surfaces are formed on different planes or on different sides of the base body. For example, the contact surfaces may be formed on the upper and lower sides of the base body and / or on the left or right side of the base body. With regard to indicating the anatomical direction when the guide component is inserted into the body of a living being, the contact surfaces may be arranged, for example, on the cranial and caudal planes of the base body and / or on the dorsal and ventral planes of the base body. Thus, in principle, this embodiment aims to ensure that the guide component can be fixed between two opposite bone structures of a living being. This promotes, for example, force-fitting clamping between the bone structures. For this purpose, for example, the distance between the two contact surfaces may be dimensioned to be slightly larger than the distance between the bone structures provided for the engagement, so that an interference fit promotes the force-fitting retention of the guide component between the bone structures. The incremental increase can also be achieved by a curved design of the contact surfaces, for example the cranial contact surface or the caudal contact surface. Of course, the shape of the contact surfaces may also be designed, in principle, as the reverse contour or undercut of the bone provided for the engagement, for example, in such a way that a form fit of the guide component to the bone structure is obtained. The embodiment having at least two opposite contact surfaces improves the retention of the guide component at the intended location inside a living being. In addition, the positioning is made easier because a plurality of contact surfaces, each assigned to a bone structure, more clearly define the positionability of the guide component.

[0032] In one particularly advantageous embodiment, the guide component is designed as an intercostal guide component, the base body of which has a cranial contact surface provided for form-fitting engagement and / or force-fitting form on the cranial ribs of the organism, and the base body also has a caudal contact surface provided for form-fitting engagement and / or force-fitting form on the caudal ribs of the organism. Thus, it is stipulated that the guide component can be positioned between two adjacent or opposite ribs, one of which forms the upper or cranial rib and the other forms the lower or caudal rib.

[0033] Of course, the guide component does not necessarily need to be applied along the entire length of the rib. In principle, a regulation can be made to the effect that the guide component is applied to a part of each rib instead. Conveniently, the cranial contact surface and the caudal contact surface of the base body are adapted to the rib shape in the region where the guide component engages with the rib. For this purpose, the contact surfaces are, for example, of a concave design so that they can exhibit a form fit against the convex part of the rib arch. The height of the guide component corresponds to the distance separating the rib portions provided for engagement. Alternatively or additionally, a slight interference fit of the guide component is useful in order to be able to exert sufficient clamping force on adjacent rib portions. However, in order not to cause a strong sense of pressure or a foreign body sensation inside the organism, or further, in order not to damage the tissue, bone structure, or the guide component, and in order not to require too much effort during the insertion of the guide component, the selected interference fit should not be too high. The advantage of the described embodiment as an intercostal guide component lies in the fact that the rib structure is particularly suitable as a mating surface for the contact surface of the guide component. The rib structure is relatively regular, and several pairs of ribs are expected as mating surfaces for the guide component, so that the installer of the guide component can relatively freely and individually determine between which rib arches and at which positions the guide component should be installed. This embodiment is also advantageous for medical applications related to the heart, since the guide component can be used to hold a line close to the heart within the thoracic cavity of the organism. As a result, the compressive and tensile forces acting on the line are borne by the guide component close to the heart, and the parts of the medical device located on the heart are spared mechanical stress.

[0034] This embodiment of the guide component adapted to the rib structure of an organism is further particularly suitable for percutaneous lines, since the guide component can be installed on the rib immediately behind the path of the line penetrating the skin, thereby enhancing the adhesiveness of the line and / or the guide component.

[0035] According to a favorable embodiment, the guide component is formed of several parts by a plurality of guide component elements. Here, it is particularly preferred that the guide component is designed in two parts, i.e., designed from two guide component elements. Specifically, the guide component can here be composed of two halves. The dividing plane of the guide component lies, for example, in the plane of the line channel. Thus, the part of the line channel is integrally formed in each of the guide component elements such that the line channel can only be closed when the guide component elements are joined together. Thereby, it becomes possible to arrange the guide component particularly gently around a line that has already been routed in the body of the organism without passing the line through the closed guide component from the end of the line. Thereby, even if the line is already in an adhered state, the guide component can still be implanted, resulting in the advantage that the guide component can be retrofitted. In practice, since the line may sometimes have a plug with a cross-section much wider than the line, sometimes it may not even be possible to pass the line through the guide component. Providing a wider line channel through which the line and the plug can pass works disadvantageously with regard to firmly holding and fixing the line within the line channel. On the contrary, since this guide component is composed of several parts and particularly the dividing plane runs through the line channel, the line channel can be optimally adapted to the cross-section or diameter of the line.

[0036] It is advantageous if the guide component elements of the multi-component guide component have connection means for creating a connection to each other, in particular a releasable connection. These are preferably connection means formed directly on the guide component elements, specifically connection means formed as one piece with the guide component elements, so that there is no need to provide additional separate connection means such as screws. Specifically, they are connection means for creating a plug-in connection, a latch connection, or a clip connection. For example, one guide component element may have a latch ear, and the other guide component element may have a latch opening into which the latch ear can be latched. By using the above-described connection means, the guide component elements can be joined quickly and easily, and particularly without tools, and they can also be separated from each other, for example, to replace the guide component. Once the guide component elements are positioned around the line to be held, they can be connected to each other simply by closing the latch connection, so there is no need to pass the line through the entire length of the line channel of the assembled guide component elements. At least one connection means is preferably arranged on the ventral plane or surface of the guide component. In this way, better accessibility and operability of the connection means can be ensured in the case of implantation performed from the ventral side of the organism.

[0037] Preferably, the base body of the guide component has a basic shape that is curved around the central axis in the head-tail direction. In the inserted state of the guide component, the central axis thus runs in the direction from the head side to the tail side or vice versa. Specifically, the curvature follows the curvature of the bone structure against which the contact surface of the guide component bears. For example, in the case of a rib, the rib runs in an arch shape when viewed horizontally, and the guide component can conform to it in shape. Thus, due to the curved basic shape, the guide component fits better to the profile of the rib or a similar bone structure, so that the retention of the guide component is further improved. It should be noted here that the curved profile of the rib as viewed in the horizontal field of view should not be identified with the curved cross-section of the rib reflected, for example, by the concave contour of the contact surface of the guide component.

[0038] According to a certain advantageous embodiment, the line channel runs between the ventral surface and the dorsal surface of the base body. Thus, the line is routed along the shortest path from the internal organ towards the human skin on the ventral or dorsal side. Moreover, this feature supports embodiments in which the guide component is positioned between the head-side bone structure and the tail-side bone structure, so that the entrance or exit of the guide channel is neither blocked nor impaired by the bone structure.

[0039] It is advantageous if the line channel for receiving and guiding the line is designed as an inclined hole penetrating the substrate. In this way, when the guide component is inserted into the body, the line channel does not run strictly vertically or horizontally. In such an embodiment, the observed line deviation is particularly small or non-existent, and the intended tensile stress removal is maximized. In addition, since there is no snagging or particularly kinking of the line at the inlet or outlet of the line channel, damage to the line while the line is guided through the guide component is prevented. In this way, cable breakage and cable kinking are reliably avoided. In the case of a percutaneous line, this further allows the external part of the line to be routed close to the skin. The external part of the line as well as the internal part are either not curved or only slightly curved, and thus no force or only a slight force acts on the exit site. This promotes rapid healing and adhesion of tissue to the line and / or the guide component.

[0040] The line channel preferably has a partially constricted cross-section. Alternatively or additionally, a fixing structure of the substrate projects into the line channel. This type of fixing structure can be formed, for example, by a knob, a material tip, a transverse web, or a similar material protrusion. In this way, the line is fixed in a targeted manner or as required and when necessary within the line channel, avoiding tensile stress. This reduces or prevents unwanted displacement of the line and increases the tensile stability of the line.

[0041] The substrate preferably has at least one fastening structure formed in one piece with the substrate. To facilitate the fixing of the guide component, the fastening structure can specifically be provided on the transverse surface, i.e., the ventral or dorsal surface of the guide component. The fastening structure can be arranged, for example, around the cable channel on the peripheral surface of the cable channel. Such a fastening structure can, for example, be in the form of one or more eyelets, so that, if necessary, the guide component can also be additionally sutured and thus fixed to the surrounding tissue, such as muscle, fascia, skin, or adipose tissue, or to the surrounding or adjacent bone structure. Other fastening structures such as clip elements or spring elements are also conceivable. Overall, the retention of the guide component at the intended position within the body of the organism is improved by the fastening structure, and the fact that the fastening structure is integrated with the substrate simplifies the manufacture of the guide component.

[0042] In one advantageous embodiment, the substrate has a ventral fastening rim in the region of the line channel. In the case of a line guided transcutaneously, the fastening rim serves to fix the skin to the guide component so that a tight seal is possible.

[0043] In one favorable embodiment, the substrate has at least one fastening opening. If necessary, fastening means such as threads or screws can be passed through such a fastening opening, which is preferably a through-hole, in order to additionally connect the substrate of the guide component to the tissue or bone structure, for example, to screw the guide component to the bone structure. Such an additional connection is useful, for example, when the expected mechanical load on the line or guide component may temporarily exceed the limiting force of the force fit and / or form fit of the guide component on the bone structure, and thus the retention of the guide component should be additionally supported.

[0044] In this case, the fastening structure, retention structure, or fixation structure is understood to mean the addition of material, while the fastening opening involves a depression of the material.

[0045] It is advantageous if one or more contact surfaces are designed as (a) groove(s) running at least partially around the substrate. In principle, this substantially corresponds to the concave embodiment of the contact surface, and the shape of the contact surface in question defines the groove bottom surface with corresponding side walls. Such a groove may be provided all around the substrate, in which case a freer orientation of the guide component during implantation of the guide component is possible. On the other hand, for example, two opposite contact surfaces can also be designed as grooves. Designing the contact surface as one or more grooves simplifies the manufacture of the guide component, improves its fit, facilitates pressing or clamping of the guide component into the bone structure, and increases the individual degrees of freedom when positioning the guide component. A particular advantage of the one or more grooves is that vessels such as blood vessels located in the bone structure, for example the intercostal artery, fit into the groove without being pinched, so that blood circulation in the bone structure is not impaired by the guide component.

[0046] It is desirable that at least one retaining structure is arranged on the groove bottom surface of the one or more grooves and is specifically formed as one piece together with the substrate. This retaining structure may be, for example, in the form of a molded knob or bar. The knob can be designed, for example, as a pointed knob having a pyramidal or conical basic shape. This retaining structure additionally protects the guide component from displacement relative to the bone structure, for example because the retaining structure increases the surface interaction between two mating partners and thus the existing frictional force.

[0047] The surface of the guide component should have the maximum possible roughness, at least on the contact surface, but preferably over the entire guide component, for example by providing a mechanically or chemically roughened surface. This enables better incorporation of the guide component and promotes positioning stability on the rib. The roughness of the individual surfaces, for example the roughness of the trailing contact surface, can be further increased by means of pointed, for example conical or pyramidal, material protrusions. The roughness increases the coefficient of static friction and thus enhances the achievable frictional connection between the guide component and the adjacent structure.

[0048] According to an advantageous embodiment, the diameter of the line channel corresponds to the diameter of the line that is to be received by the line channel. In this context, since the line is guided flush within the line channel, among other things, the entry of liquid or tissue into the line channel is prevented, so that it is not possible for tissue to be pinched or liquid to accumulate. Thus, this further reduces the risk of trauma and inflammation in the guide component. In addition, the frictional acceptance of the line within the line channel already ensures that the position of the line is fixed against axial displacement.

[0049] In a utilitarian embodiment, the guide component is made of a biocompatible material, in particular a biocompatible metal or plastic. In this way, a high degree of material compatibility of the guide component is achieved simultaneously with a high degree of stability and long service life of the guide component.

[0050] The invention will be explained in more detail below, based on exemplary embodiments, with reference to the accompanying schematic drawings.

Brief Description of the Drawings

[0051]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Mode for Carrying Out the Invention

[0052] Figure 1 shows a multi-part configuration embodiment of the guide component 1 according to the invention, specifically a two-part configuration embodiment, and the guide component 1 is composed of two guide component elements 5a, 5b that are releasably connected to each other. The guide component 1 is intended to guide, hold, and fix one or more lines (not shown) of a medical device within the body of a living being. For this purpose, the guide component 1 has a contact surface 4 (shown in other figures) that is designed for form-fitting and / or force-fitting engagement with the bone structure of the living being. Thereby, the guide component 1 can be quickly and easily fixed by engaging with one or more bone structures at the intended site within the body of the living being, for example, by clamping the bone. The illustrated guide component 1 is particularly intended to be arranged as an intercostal guide component 1 between two adjacent or opposite ribs of a living being. Regarding the implanted state of the guide component 1, the view in Figure 1 is a dorsal view of the guide component 1, that is, a view facing the back of the living being. The figure shows a base body 2 with a substantially rectangular cross-section and a line channel designed as an inclined through-hole that extends substantially through the center of the base body 2. Thanks to the inclined hole, there is little or no deflection of the line that can be observed, and thus the intended tensile stress removal is maximized. In addition, since there is no snagging or particularly kinking of the line at the entrance or exit of the line channel 3, damage to the line while being guided through the guide component 1 is prevented. In the illustrated embodiment, the line channel 3 runs from the ventral surface 8 of the base body 2 to the dorsal surface 9 of the base body 2. As can be particularly seen in Figure 3, the cranio-caudal central axis 7 of the base body 2 runs through the base body 2, and the base body 2 is slightly curved around its central axis 7. Figure 1 further shows a fastening structure 10 in the form of a total of eight eyelets that are integrated with the base body 2 and arranged on the dorsal surface 9 of the base body 2, and these eyelets enable, for example, the guide component 1 to be sutured to a bone structure, a skin structure, or a tissue structure. Thereby, it becomes possible to achieve additional retention of the guide component 1 at the intended position within the body of the living being when necessary.In addition, FIG. 1 shows a total of four fastening openings 11 in the base body 2 through which a thread or screw can be guided so that, for example, the guide component 1 can be fixed to a biological bone structure or tissue structure by means of a screw connection. Thereby, if necessary, additional retention of the guide component 1 at the intended position within the body of the organism can be achieved. The guide component 1 has a slight curvature in the region of its surrounding caudal contact surface 4b, which results in a slight interference of the guide component 1 and increases the contact pressure acting on the adjacent bone structure in the inserted state of the guide component 1.

[0053] Figure 2 shows a perspective dorsal view of the guide component 1. The components of the guide component 1 that are positioned on or visible on the dorsal surface 9 of the substrate 2 have already been described with reference to FIG. 1. FIG. 2 further shows a contact surface 4 for attaching the substrate 2 to a biological bone structure using form-fitting engagement and / or force-fitting engagement in the implanted state of the guide component 1. It can be seen that the contact surface 4 is arranged as a concave contact surface 4 around the guide component 1 between the dorsal surface 9 and the ventral surface 8. Due to the concave shape, the guide component 1 is particularly suitable for convex bone structures or bone parts such as ribs. In the view of FIG. 2, the contact surface 4 is the caudal contact surface 4b of the guide component 1. When the guide component 1 is inserted, for example, between two rib arches, the caudal contact surface 4b lies on the cranial part facing the head of the upper rib arch. In the illustrated embodiment, the contact surface 4 is designed as a peripheral groove 12 around the guide component having a groove side wall 13 and a groove bottom surface 14 shown in further figures. By means of the contact surface 4 designed as the groove 12, any blood vessels of the bone structure can be received without being pinched, so the blood circulation in the bone structure is not impaired by the guide component 1. Thanks to the fact that the groove 12 is formed all around, that is, continuously defining the peripheral shape of the guide component 1 without interruption, the guide component 1 can be positioned relatively freely on the bone structure, for example, it can be positioned in a slightly inclined position, or it can be positioned at a place where the guide component 1 is surrounded or enclosed by several bones. However, in principle, it is also conceivable to provide only a part of the groove 12 or to provide several grooves 12.

[0054] Figure 3 shows a caudal view of the two-part guide component 1 with the two guide component elements 5a, 5b assembled. This view shows the contact surface 4 for placing the base body 2 on the bone structure of a living being using form-fitting engagement and / or force-fitting engagement in the implanted state of the guide component 1. It can be seen that the contact surface 4 is arranged as a concave contact surface 4 around the guide component 1 between the dorsal surface 9 and the ventral surface 8. Due to the concave shape, the guide component 1 is particularly suitable for convex bone structures or bone parts such as ribs. In the view of Figure 3, the contact surface 4 is the caudal contact surface 4b of the guide component 1. When the guide component 1 is inserted, for example, between two costal arches, this caudal contact surface 4b lies on the cranial part facing the head of the upper costal arch. In the illustrated embodiment, the contact surface 4 is designed as a peripheral groove 12 around the guide component 1 having groove side walls 13 and a groove bottom surface 14. By means of the contact surface 4 designed as the groove 12, any vessel such as a blood vessel of the bone structure can be received without being pinched, so that the blood circulation in the bone structure is not impaired by the guide component 1. Thanks to the fact that the groove 12 is formed all around, that is, continuously defines the peripheral shape of the guide component 1 without interruption, the guide component 1 can be positioned relatively freely on the bone structure, for example, it can be positioned in a slightly inclined position, or the guide component 1 can be positioned where it is surrounded or enclosed by several bones. However, in principle, it is also conceivable to provide only part of the groove 12 or to provide several grooves 12. In the caudal contact surface 4b, a retaining structure 15 is formed on the bottom 14 of the groove, and this retaining structure 15 protrudes from the groove bottom surface 14 and is in the form of a knob integral with the base body 2. These additionally protect the guide component 1 from displacement relative to the bone structure due to the fact that the retaining structure 15 enhances the surface interaction between the contact surface and the bone structure and thus increases the existing frictional force.

[0055] Figures 4 and 5 each show a side view of the two-part guide component 1, and in those figures as well, the design of the contact surface 4 as the peripheral groove 12 having the groove side wall 13 and the groove bottom surface 14 is clear. The contact surface 4 shows the transition to the caudal contact surface 4b on the lower side of the drawing and the transition to the cranial contact surface 4a on the upper side of the drawing.

[0056] Figures 6 and 7 successively show a dorsal view and a ventral view of the two-part guide component 1 with the guide component elements 5a, 5b separated from each other. Both figures show a connecting means for connecting the two guide component elements 5a, 5b, that is, a connecting element in the form of a latch ear portion 6a of the guide component element 5a and a corresponding latch opening 6b of the guide component element 5b. In the assembled state of the guide component 1, the latch ear portion 6a is engaged with the latch opening 6b of the guide component element 5b. By inserting and fitting them together, that is, inserting the latch ear portion 6a into the latch opening 6b and locking it, the two guide component elements 5a, 5b can be connected to each other in a reliable but releasable manner. It can also be seen that the splitting plane of the guide component 1 for separating the guide component elements 5a, 5b runs through the line channel 3. Therefore, one part of the line channel 3 is integrally formed on the side of one guide component element 5a as a channel with a semicircular cross-section, and the other part of the line channel 3 is integrally formed on the side of the other guide component element 5b as a channel with a semicircular cross-section. The line channel 3 is closed by joining the two guide component elements 5a, 5b together. In this way, a line already routed in the body of a living being can be surrounded by the line channel 3 of the guide component 1.

[0057] On the wall of line channel 3, there is also a fixing structure 16 that protrudes into line channel 3. The fixing structure 16 is formed, for example, by an elongated material protrusion. In this way, the line is fixed in a targeted manner within the line channel or as needed and when necessary, avoiding tensile stress. This reduces or prevents undesired displacement of the line and enhances the tensile stability of the line.

[0058] The guide component 1 is biocompatible and is preferably made of a metal or plastic that is thus very compatible with the surrounding tissues and bone structures of the organism. The guide component 1 can have a certain basic elasticity in order to be fastenable to the bone structure, for example, by clamping it to the bone structure without much effort. On the other hand, the guide component 1 should also have sufficient basic stability to ensure reliable retention of the line.

[0059] The anatomical direction designations such as cephalad, caudal, ventral, and dorsal used in this application are for illustrative purposes only and are provided to advance the spatial concept of the subject matter of the invention. The direction designations should not be understood to be restrictive in the sense that the guide component according to the invention can only be inserted into the body of the organism in one orientation and one position. Thus, in principle, for example, the ventral and dorsal surfaces of the guide component can be interchanged, and similarly, the cephalad and caudal surfaces can be interchanged. Likewise, by pivoting the guide component 1, for example, by 90 degrees, what was previously the lateral contact surface of the guide component can become the cephalad contact surface or the caudal contact surface. 〔Aspect 1〕 An in-vivo guide component (1) for guiding a line of a medical device, particularly a percutaneous line, inside a living being, the guide component (1) having a substrate (2) with a line channel (3) for receiving and guiding the line, wherein the substrate (2) has one or more contact surfaces (4, 4a, 4b) designed for form-fit engagement and / or force-fit engagement with the bone structure of the living being around it. The in-vivo guide component (1) is characterized by this. 〔Aspect 2〕 In the in-vivo guide component (1) according to Aspect 1, the substrate (2) has at least two opposite contact surfaces (4, 4a, 4b) designed for form-fit engagement and / or force-fit engagement with the bone structure of the living being. The in-vivo guide component (1) is characterized by this. 〔Aspect 3〕 In the in-vivo guide component (1) according to Aspect 2, the guide component (1) is designed as an intercostal guide component (1), the substrate (2) has a cranial contact surface (4a) provided for form-fit engagement and / or force-fit engagement with the cranial rib of the living being, and the substrate (2) has a caudal contact surface (4b) provided for form-fit engagement and / or force-fit engagement with the caudal rib of the living being. The in-vivo guide component (1) is characterized by this. 〔Aspect 4〕 In the in-vivo guide component (1) according to any one of Aspects 1 to 3, the guide component (1) is formed by several parts by a plurality of guide component elements (5a, 5b), particularly formed by two parts by two guide component elements (5a, 5b). The in-vivo guide component (1) is characterized by this. 〔Aspect 5〕 In the in-vivo guide component (1) according to Aspect 4, the guide component elements (5a, 5b) of the multi-component guide component have connection means for creating a connection to each other, particularly a releasable connection. The in-vivo guide component (1) is characterized by this. 〔Aspect 6〕 In the in-vivo guide component (1) according to any one of Aspects 1 to 5, The internal guide component (1), characterized in that the base body (2) of the guide component (1) has a basic shape curved around the central axis (7) in the head-tail direction of the base body (2). [Aspect 7] In the internal guide component (1) according to any one of Aspects 1 to 6, The internal guide component (1), characterized in that the line channel (3) runs between the ventral surface (8) and the dorsal surface (9) of the base body (2). [Aspect 8] In the internal guide component (1) according to any one of Aspects 1 to 7, The internal guide component (1), characterized in that the line channel (3) for receiving and guiding the line is designed as an inclined hole penetrating the base body (2). [Aspect 9] In the internal guide component (1) according to any one of Aspects 1 to 8, The internal guide component (1), characterized in that the line channel (3) has a partially constricted cross-section and / or a fixing structure of the base body (2) protrudes into the line channel (3). [Aspect 10] In the internal guide component (1) according to any one of Aspects 1 to 9, The internal guide component (1), characterized in that the base body (2) has at least one fastening structure (10) formed as one piece with the base body (2). [Aspect 11] In the internal guide component (1) according to any one of Aspects 1 to 10, The internal guide component (1), characterized in that the base body (2) has at least one fastening opening (11). [Aspect 12] In the internal guide component (1) according to any one of Aspects 1 to 11, The internal guide component (1), characterized in that the one or more contact surfaces (4, 4a, 4b) are designed as a groove (12) or a plurality of grooves (12) running at least partially around the base body (2). [Aspect 13] In the internal guide component (1) according to Aspect 12, The internal guide component (1), characterized in that at least one holding structure (15), particularly at least one holding structure (15) formed as one piece with the base body (2), is arranged on the bottom surface (14) of the groove (12) or the plurality of grooves (12). 〔Aspect 14〕 In the in-vivo guide component (1) according to any one of Aspects 1 to 13, the in-vivo guide component (1) is characterized in that the diameter of the line channel (3) corresponds to the diameter of the line to be received by the line channel (3). 〔Aspect 15〕 In the in-vivo guide component (1) according to any one of Aspects 1 to 14, the in-vivo guide component (1) is characterized in that the guide component (1) is made of a biocompatible metal or a biocompatible plastic.

Explanation of Symbols

[0060] 1 Guide component 2 Substrate 3 Line channel 4 Contact surface 4a Cephalic contact surface 4b Caudal contact surface 5a, 5b Guide component elements 6a Latch ear 6b Latch opening 7 Cephalocaudal central axis 8 Ventral surface 9 Dorsal surface 10 Fastening structure 11 Fastening opening 12 Peripheral groove 13 Groove side wall 14 Groove bottom surface 15 Holding structure 16 Fixing structure

Claims

1. A long-term in-vivo guide component (1) for guiding a percutaneous line of a medical device inside a living being, said guide component (1) having a substrate (2) with a line channel (3) for receiving and guiding said line, wherein said substrate (2) has at least two opposite contact surfaces (4, 4a, 4b) designed for form-fit engagement and / or force-fit engagement with the bone structure of said living being around it, said guide component (1) is formed by several parts by a plurality of guide component elements (5a, 5b), and said line channel (3) closes only when said guide component elements (5a, 5b) are combined, the diameter of said line channel (3) corresponds to the diameter of said line to be received by said line channel (3), said guide component (1) is designed as an intercostal guide component (1), said substrate (2) has a cranial contact surface (4a) provided for form-fit engagement and / or force-fit engagement with the cranial ribs of said living being, and said substrate (2) has a caudal contact surface (4b) provided for form-fit engagement and / or force-fit engagement with the caudal ribs of said living being. The in-vivo guide component (1) is characterized by this.

2. The in-vivo guide component (1) according to claim 1, wherein said guide component (1) is formed by two parts by two guide component elements (5a, 5b). The in-vivo guide component (1) is characterized by this.

3. The in-vivo guide component (1) according to claim 1 or 2, wherein said guide component elements (5a, 5b) of said multi-component guide component have connection means for creating a connection. The in-vivo guide component (1) is characterized by this.

4. The in-vivo guide component (1) according to claim 3, wherein said guide component elements (5a, 5b) of said multi-component guide component have connection means for creating a releasable connection with each other. The in-vivo guide component (1) is characterized by this.

5. In the in-vivo guide component (1) according to any one of claims 1 to 4, The in-vivo guide component (1), characterized in that the base body (2) of the guide component (1) has a basic shape curved around the central axis (7) in the head-tail direction of the base body (2).

6. In the in-vivo guide component (1) according to any one of claims 1 to 5, The in-vivo guide component (1), characterized in that the line channel (3) runs between the ventral surface (8) and the dorsal surface (9) of the base body (2).

7. In the in-vivo guide component (1) according to any one of claims 1 to 6, The in-vivo guide component (1), characterized in that the line channel (3) for receiving and guiding the line is designed as an inclined hole penetrating the base body (2).

8. In the in-vivo guide component (1) according to any one of claims 1 to 7, The in-vivo guide component (1), characterized in that the line channel (3) has a partially constricted cross-section and / or a fixing structure of the base body (2) protrudes into the line channel (3).

9. In the in-vivo guide component (1) according to any one of claims 1 to 8, The in-vivo guide component (1), characterized in that the base body (2) has at least one fastening structure (10) formed as one piece with the base body (2), and the fastening structure (10) holds the in-vivo guide component (1) at an intended position within the body of a living being.

10. In the in-vivo guide component (1) according to any one of claims 1 to 9, The in-vivo guide component (1), characterized in that the base body (2) has at least one fastening opening (11) for guiding through fastening means.

11. In the in-vivo guide component (1) according to any one of claims 1 to 10, The in-vivo guide component (1), characterized in that the one or more contact surfaces (4, 4a, 4b) are designed as a groove (12) or a plurality of grooves (12) running at least partially around the base body (2).

12. In the in-vivo guide component (1) according to claim 11, The in-vivo guide component (1) is characterized in that at least one holding structure (15) for enhancing the surface interaction between the contact surface and the bone structure is arranged on the groove bottom surface (14) of the groove (12) or the plurality of grooves (12).

13. In the in-vivo guide component (1) according to claim 12, The in-vivo guide component (1) wherein the at least one holding structure (15) is formed as one piece together with the base body (2).

14. In the in-vivo guide component (1) according to any one of claims 1 to 13, The in-vivo guide component (1) is characterized in that the guide component (1) is made of a biocompatible metal or a biocompatible plastic.

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