Method for manufacturing medical clips and medical implants

Abstract

The present invention relates to a method for manufacturing a medical implant, particularly a medical clip, wherein the implant surface of the medical implant has a colored finish. [Solution] To improve medical clips, particularly in the form of aneurysm clips, which comprise two clamp arms 24 and a biasing element 32, it is proposed that in each case one clamp arm is positioned or formed on the free end of the biasing element, the two clamp arms are in contact with each other in a basic position and are movable to an open position so as to move away from each other against the movement of the biasing element, and that at least a portion of the surface of the clip is colored to achieve clear distinguishability of the clip, and that the clip defines at least three spatially separated clip regions 38, 46, 42, and that at least three clip regions are colored in different colors.

Description

Technical Field

[0001] The present invention relates to a medical clip in the form of an aneurysm clip, in particular, comprising two clamping arms and a biasing element, in each case one clamping arm being arranged or formed on the free end of the biasing element, the clamping arms being in contact with each other in the basic position and being movable to an open position so as to move away from each other against the action of the biasing element, and at least a part of the surface of the clip being in a colored configuration.

[0002] Furthermore, the present invention relates to a medical clip system comprising at least two medical clips, at least one clip being configured in the form of a permanent clip whose surface is in a particularly fully colored configuration, at least one clip corresponding to the shape and / or size of the permanent clip being configured such that its surface is at least partially color-corresponding to the permanent clip, and being configured in the form of a temporary clip that is at least partially colored for coding as a temporary clip.

[0003] Furthermore, the present invention relates to a method for manufacturing a medical implant, in particular a medical clip or a medical screw, wherein the implant surface of the medical implant is in a colored configuration.

Background Art

[0004] Clip systems of the type described at the beginning are known in particular in the form of aneurysm clip systems. In this case, the so-called permanent clip is in a completely single-color configuration. Thereby, the color serves in particular to code the form and / or size of the permanent clip.

[0005] Prior to the final placement of such permanent clips, which are intended to remain permanently in the patient's body, so-called temporary clips are used during surgery, for example, to treat an aneurysm. These are partially colored with a color corresponding to the permanent clip they are temporarily replacing, and are also partially colored as a coding to indicate that the clip is a temporary clip. The colored design or coding of such temporary clips allows surgeons to distinguish, on the one hand, the size and / or shape of the clips, and on the other hand, to distinguish between temporary clips and permanent clips. [Overview of the Initiative]

[0006] A problem with such clip systems is that surgeons, particularly in minimally invasive procedures, cannot always clearly distinguish between temporary and permanent clips. This can be because, for example, some of the clips kept in a single color to coat them as temporary clips may be covered by the insertion instrument. As a result, temporary and permanent clips may become mixed in an undesirable manner.

[0007] Therefore, an object of the present invention is to improve the types of medical clips, medical clip systems, and methods described at the beginning so that reliable distinction of clips can be made.

[0008] This objective is achieved in the type of medical clip described at the beginning of the present invention, in that the medical clip defines at least three spatially separated clip regions, and adjacent clip regions of the at least three clip regions are colored in different colors.

[0009] Further development of known clips, which are specific embodiments of medical implants, in the manner described has the advantage of allowing such medical clips to be identified in a simple and reliable manner, particularly as temporary clips. Such identification can be reliably guaranteed, especially in minimally invasive surgical procedures under a microscope, or when such clips are applied and, for example, are housed in the opening of an application tool and thereby partially obscured. For example, two of the three clip regions may be defined by the first and second end regions of the clip. For example, if an end or end region of a clip forming a medical implant is grasped by an application tool and thereby obscured, the other end or end region of the clip remains clearly visible. Thus, the user can reliably recognize whether a clip is a temporary clip or a permanent clip, regardless of whether the clip is partially obscured or not. Furthermore, clear distinguishability of clips on the operating table or in a storage and classification basket can be achieved, in particular, even in darkened rooms such as a dimly lit operating room. Furthermore, it should be noted that the medical clip is a medical implant that may be configured not in the form of a medical clip, particularly an aneurysm clip, but in the form of a medical screw, such as a bone screw or a pedicle screw. Such a medical implant has an implant surface, at least a portion of which is colored, and at least three spatially separated implant regions are defined on the implant, with at least three adjacent implant regions being colored in different colors. The present invention is not limited to medical implants in the form of medical clips, but rather includes any implant, particularly in the form of a medical screw.Furthermore, the colored configuration should be understood to mean, in particular, that at least three clip or implant regions are colored, i.e., formed of a colored material, or colored by, for example, a coating, having only colored surfaces that leave a colored impression on the observer. Thus, the material forming the configuration may be a different color from the implant surface within at least three implant regions. Furthermore, in the sense of the claims, adjacent should be understood to mean adjacent implant or clip regions colored in different colors that are adjacent to each other, and the adjacent regions preferably do not overlap, but instead are positioned or formed next to each other with no distance between them or only a small distance between them. The implant or clip regions may, in particular, form any part of the implant or clip.

[0010] It is advantageous if at least two of the three clip regions are colored the same color, and these at least two clip regions are not directly adjacent to each other. This configuration, in particular, allows for designing ends that are spaced apart from each other on an implant in the same color. For example, if the end is grasped and held by an application tool, the second end of the implant is still visible to the surgeon or another user, allowing for reliable and dependable distinction of such a clip from, for example, a single-color clip.

[0011] Preferably, the first clip region of at least two clip regions comprises the free ends of two clip arms, the second clip region of at least two clip regions comprises a biasing element or a part thereof, and at least one third clip region of at least two clip regions is positioned or formed between the first and second clip regions. This proposed further development makes it possible to form a clip comprising three, four, five, or more clip regions, wherein the clip regions have different shapes. Thus, for example, a clip can be formed having three, four, five, or more strips defined by the clip regions. In particular, several different clip regions minimize the probability that all clip regions that help identify the clip as a temporary clip are simultaneously obscured. In other words, at least one of the clip regions that identifies the clip as a temporary clip is therefore, with a very high probability, always visible to the user.

[0012] The first and second clip regions are preferably lighter in color than at least one third clip region. Therefore, such clips can be reliably identified at the surgical site, for example, as temporary clips not intended for permanent implantation.

[0013] Preferably, at least one of the three clip regions is colored green, blue, purple, yellow, or gold. For example, green, blue, and purple can be used to characterize the shape and / or size of the clip, and a yellow or gold clip region can be used to characterize a temporary clip so that it can be distinguished from a permanent clip, i.e., a clip that is permanently implanted.

[0014] It is advantageous if the surface of at least one third clip region is yellow or gold in color, or if the surfaces of the first and second clip regions are yellow or gold in color. In this way, it is possible to achieve that at least one yellow or gold clip region remains visible even when the clip is gripped on an end, i.e., on a second clip region, and obscured by an application instrument.

[0015] In a more preferred embodiment of the present invention, it can be realized that two adjacent clip regions among at least three clip regions define a colored transition region on the surface, and that the colored transition region is positioned or formed on a geometrically defined region of the clip. In particular, the colored transition region may be a geometrically defined region of the clip, and the cross-section of the geometrically defined region is constant, tapered conically, or widens for a region length corresponding to at least about 5%, particularly about 10%, of the total length of the clip. The colored transition region may be much shorter than the region length, particularly compared to the total length of the clip. For example, adjacent clip regions may have a step function-like color transition, i.e., a more or less abrupt color change in spatially directly adjacent areas. Defined color transitions can be achieved in particular by providing a transition region on a geometrically defined region of the clip. In particular, the geometrically defined region may be defined by a region or portion of the implant with a constant cross-section. This can be particularly within the area of ​​the clamp arm. Geometrically defined areas are, for example, cylindrical portions or regions with a certain cross-section, or conical portions or regions whose cross-section increases or decreases linearly, for example. Such areas can be formed, for example, within the area of ​​the free end of the biasing element. Thus, in particular, the manufacture of clip areas colored in different colors can be improved, resulting in clearer coloring of different clip areas.

[0016] Preferably, the surface of at least one of the three clip regions is colored by a coating. In particular, all clip regions may be colored by a coating. In particular, they may be different types of coatings. For example, one clip region may be formed by anodizing. The second and / or third clip regions may be formed by coating using a metal coating by a dipping process, for example. In particular, multiple layers of coating may be arranged in order on top of each other in one or more clip regions. In particular, the entire clip may be colored by an anodic coating. Then, the second and / or third clip regions may be provided with a metal coating by an additional coating in a dipping process or by further anodizing.

[0017] The thickness of the coating layer is preferably in the range of about 10 nm to about 500 nm. In particular, the layer thickness is in the range of about 20 nm to about 200 nm. Such layer thicknesses allow for the use of interference effects for coloring, especially when the coating is composed in the form of an oxide layer. For example, a titanium oxide layer can be formed on a clip made of titanium by anodizing in the manner described above. Different layer thicknesses result in different colors, for example. The layer thickness can also be within the specified range in the case of immersion coating. Thus, reliable and long-lasting coating of the clip in one or more clip regions can be achieved with minimal material consumption, which is advantageous, for example, in the case of gold coating.

[0018] When the coating consists of an oxide layer formed by anodizing, clips can be formed in a simple and cost-effective manner. In particular, by appropriately setting the process parameters during anodizing, the color of the oxide layer can be predetermined in a desired and defined way.

[0019] Furthermore, it may be preferable that the oxide layer forms an interference filter, and that the color effect of the oxide layer depends on its thickness. Therefore, in particular, a very long-lasting and stable colored coating can be formed on the clip. The desired thickness of each oxide layer can be specified by the corresponding process parameters during anodizing.

[0020] The manufacturing of clips can be further simplified if the same coating is applied to clip regions having surfaces of the same colored configuration. Therefore, in particular, the same coating can be applied to two or more clip regions in a single process step.

[0021] The coating preferably contains gold or consists of gold. Such coatings are particularly used for materials to form medical clips that are not suitable for anodizing, such as clips made of cobalt-chromium alloys, particularly Phynox. For example, the areas at both ends of the clip, i.e., the free end of the clamp arm on one side and the biasing element on the other, can be coated with gold in an immersion process.

[0022] Medical clips can be coated in a simple manner if the coating is in the form of an immersion coating. For example, gold coating can be achieved on non-oxidizable materials.

[0023] Furthermore, it is advantageous if at least one of the three clipping regions is not coated. In that case, such a clipping region has the color of the material forming the clip. For example, this material may have a natural oxide layer, such as aluminum, which is protected from corrosion by a passivated aluminum oxide layer.

[0024] The clip is preferably formed of a biocompatible metal. Thus, in particular, the rejection reaction of the clip after implantation can be minimized. The biocompatible metal can particularly be titanium, aluminum, or tantalum. It may also be a metal alloy.

[0025] The metal alloy preferably contains cobalt and / or chromium and / or nickel. The described metals can be used in appropriate combinations, particularly for forming implantable biocompatible implants. For example, such an alloy can be Phynox.

[0026] According to the present invention, the above-mentioned object is further achieved in a medical clip system of the type described at the beginning in that the temporary clip is configured in one of the preferred embodiments of the above-mentioned medical clip.

[0027] The further developed clip system, as proposed, enables a reliable distinction between the temporary clip and the permanent clip. For further advantages, reference is made to the above description.

[0028] It is preferable that the color of the surface of the permanent clip forms a coding of the shape and / or size of the permanent clip. Thus, the user can directly recognize the shape and / or size of the permanent clip by the color or coloring. For example, a simple association with the respective shape / size of the corresponding application instrument can also be achieved if the application instrument is provided with the corresponding coding, for example, if it is completely or partially colored with the color of the permanent clip.

[0029] Each of at least two medical clips comprises two clamp arms and a biasing element, in each case one clamp arm being arranged or formed at the free end of the biasing element, the two clamp arms being in contact with each other in the basic position and being movable to an open position against the action of the biasing element so as to move away from each other. In clips of this kind, in particular, aneurysms or other growths on hollow organs can be treated, for example, in a defined manner by clamping them.

[0030] The permanent clip and the associated temporary clip are preferably of the same configuration except for the coloring. Thus, the user can temporarily use the temporary clip until the permanent clip is applied and then remains permanently within the patient. Thus, the surgeon can first use different temporary clips in order to select the clip that is optimal for each procedure, i.e., with respect to its shape and size. Thus, after the final selection, the surgeon can replace the temporary clip with the permanent clip. By the color coding of the clips configured as proposed, the surgeon can reliably distinguish whether the clip used is configured in the form of a temporary clip or in the form of a permanent clip.

[0031] The clip system advantageously comprises at least two permanent clips that differ in size and / or shape. Thereby, the user can have appropriate clips available for various symptoms. The clip system can in particular comprise 5, 10, 20, or more clips of different shapes and corresponding sizes.

[0032] According to the invention, the object stated at the beginning is further achieved in a manner of the kind stated at the beginning, in which at least three implant regions spatially separated from each other are defined on the implant and adjacent implant regions of the at least three implant regions are colored in different colors.

[0033] Further developments of the method described at the beginning have the advantages already mentioned above, particularly in relation to preferred embodiments of medical implants in the form of medical clips. Users can reliably distinguish medical implants manufactured in this manner from, for example, single-color implants. The colored configuration should be understood to mean, in particular, that at least three implant regions are colored, i.e., formed of colored material, or that only the implant surface is colored, for example by a coating, so as to give the observer a colored impression. For example, materials may be selected to form an implant in which the implant surface is a different color from that of at least three implant regions.

[0034] It is advantageous if at least two of the three implant regions are colored the same color, and these at least two implant regions are not directly adjacent to each other.

[0035] Preferably, at least two of the three implant regions are colored the same, and these at least two implant regions are not directly adjacent to each other. In other words, these two implant regions are spaced apart from each other, for example, they are further separated from each other by implant regions of different colors. Configuring two implant regions to be the same color has the advantage that the implants can be clearly identified, especially when one of the two implant regions of the same-colored configuration is not visible, for example, because it is obscured by instruments or tissues within the surgical site. Thus, clear separation of different implant regions can be achieved by appropriate coloring. Furthermore, the user can reliably identify the type of clip, i.e., temporary clips or permanent clips, especially under optically unfavorable conditions such as under a microscope, in minimally invasive surgery, or under dim lighting.

[0036] It is advantageous when at least two adjacent implant regions out of three implant regions define a surface colored transition region, and when the colored transition region is located or formed on a geometrically defined region of the implant. In particular, the colored transition region may be located or formed on a geometrically defined region of the implant, and its cross-section may be constant for a region length corresponding to at least about 5%, particularly about 10%, of the total length of the implant, or it may taper or widen in a conical shape. Thus, particularly in regions where the cross-section of the implant is varied or constant, clearly separated implant regions of different colors can be obtained. In particular, the protective layer used in a preferred embodiment of the method can be reliably applied in the case of such clearly defined geometric regions to obtain a clear and sharp boundary between adjacent clipping regions of different colors.

[0037] To enable optical differentiation of as many different types of implants as possible, it is advantageous that at least one of the three implant regions is colored green, blue, purple, yellow, or gold.

[0038] It is preferable that a first implant region of at least three implant regions is defined by a first end region of the implant, a second implant region of at least three implant regions is defined by a second end region of the implant, and at least one third implant region of at least three implant regions is positioned or formed between the first and second implant regions. Therefore, in particular, an implant having three colored clip regions can be formed. For example, two of the three clip regions may be colored the same color. Of course, the implant may consist of four, five, six, or more clip regions of different colors. In particular, it is conceivable to alternately color adjacent clip regions differently, i.e., for example, to provide only two colors in a total of six clip regions to distinguish them. Therefore, in particular, a striped implant can be formed in a simple manner.

[0039] In particular, to achieve good distinguishability even under insufficient lighting conditions, it is preferable that the first and second implant regions are lighter in color than at least one third implant region. Therefore, even if one of the two implant regions, the first and second implant regions, is covered and not visible to the user, the other of these two implant regions remains visible, making it possible to reliably distinguish the multi-color implant from a single-color implant.

[0040] It is advantageous if the surface of at least one third implant region is yellow or gold in color, or if the surfaces of the first and second implant regions are yellow or gold in color. For example, the yellow or gold design of the described clip regions may be used to identify temporary implants used only temporarily during surgery, for example, to determine the optimal size and shape of the final permanent implant to be implanted.

[0041] It is advantageous if at least one of the three implant regions, and especially all implant regions, has a colored coating on its surface. The colored coating can be simply and reliably applied or formed on the implant. In particular, such a coating on a biocompatible material can also serve the purpose of allowing implants made of non-biocompatible materials to be used to form biocompatible implants, as it helps prevent direct contact between the biocompatible material forming the implant and the patient's tissue.

[0042] The coating is preferably formed with a layer thickness in the range of about 10 nm to about 500 nm. In particular, the layer thickness may have a value in the range of about 20 nm to about 200 nm. A coating with a layer thickness within the specified range can also provide particularly good corrosion protection for the implant itself. Thin coatings can be formed in a particularly cost-effective manner. Furthermore, it is possible to form an oxide layer with such a layer thickness on the implant to obtain an interference filter on which the color effect of the oxide layer is predetermined, for example. In other words, coatings of different thicknesses can produce different color effects.

[0043] The coating can be formed in the form of an oxide layer by a simple method of anodizing. During anodizing, an oxide layer of the material from which the implant is manufactured is formed. For example, if the implant is made of titanium, the oxide layer may be formed from titanium oxide.

[0044] The manufacturing of medical implants can be simplified if the same coating is applied to implant regions having surfaces of the same color. Therefore, two or more implant regions can have surfaces of the same color in a single process step.

[0045] Preferably, the coating is formed by gold plating. For example, this can be achieved by an immersion process. This type of coating has the advantage that it is possible even with materials that are not suitable for anodizing to form an oxide layer. For example, a coating formed by gold plating can be used with implants formed from cobalt-chromium steel or other materials containing cobalt and / or chromium.

[0046] Preferably, at least one of the at least three implant regions remains uncoated. This can be provided particularly when the implant material is biocompatible or already has a passivating layer. Thus, at least one method step, namely the method step of coating at least one implant region to similarly color it, can be omitted.

[0047] In a more preferred embodiment of the present invention, it may be realized that the implant is formed of a biocompatible metal and / or an oxidizable metal or metal alloy. In particular, titanium, aluminum, or tantalum may be used as the metal in the implant material. Such implants can minimize rejection reactions by the patient's body after implantation.

[0048] This method is advantageous when the implant is introduced into an electrolyte, and when the implant is connected to the anode of a DC voltage source and subjected to an anodic oxidation voltage for the purpose of anodizing. The electrolyte may be a diluted acid in particular. The described method allows for the simple formation of an oxide layer, i.e., an oxide layer corresponding to the material on which the implant is formed.

[0049] If different anodic oxidation voltages are applied to the implant to form different colors during anodizing, the implant can be colored in a characteristic way in a simple manner. For example, different implant regions can be colored differently by partially covering one or more implant regions before anodizing, and then the implant receiving a first anodic oxidation voltage to form a first oxide layer on the uncovered implant regions. Then, in a further method step, the clip region that has already been coated with the oxide layer can be covered, and the implant can receive another, for example, a lower anodic oxidation voltage to provide an oxide layer of a different color to the remaining implant region.

[0050] In a preferred embodiment of the method, at least one of at least three implant regions may be covered with a protective layer, the implant may then be anodized at a first anodizing voltage to form a first oxide layer on the implant surface not covered with the protective layer, the protective layer may be removed, and then the implant may be anodized at a second anodizing voltage to form a second oxide layer on the implant surface, the first anodizing voltage being greater than the second anodizing voltage. This method has the advantage that, because the second anodizing voltage is lower than the first anodizing voltage, the initially formed oxide layer is not altered by the second oxide layer formed in the second anodizing step. Thus, the first oxide layer remains unchanged. In contrast, the second oxide layer may be provided on a second or yet another implant region that was initially covered with the protective layer, resulting in a different color effect due to the different anodizing voltage.

[0051] When the protective layer is formed by a resin layer, the implant can be partially covered in a simple manner. For example, the implant can be immersed in the resin. Thus, immersion coating can be achieved. When the resin dries and hardens, further areas of the implant can also be optionally covered with such a protective layer.

[0052] To enable the implant to be used for a variety of purposes, it is preferable that the implant be configured in the form of a medical clip or a medical screw. In particular, the medical screw may be configured in the form of a bone screw or a pedicle screw. Of course, the use of the described method is not limited to medical implants in the form of medical clips or medical screws. In principle, a medical implant can be any type of implant.

[0053] It is advantageous if a medical clip consists of two clamp arms and a biasing element, and in either case, one clamp arm is positioned or formed on the free end of the biasing element, and the two clamp arms are in contact with each other in a basic position and are movable to an open position so as to move away from each other against the movement of the biasing element. For example, three implant regions on a medical clip can be formed on one hand by the free ends of the two clamp arms and on the other hand by the biasing element and the region formed between them. Such a medical clip can be used in particular as an aneurysm clip for treating aneurysms.

[0054] To obtain optimal coloring of the clip, particularly the surfaces that come into contact with each other in their basic position, such as the clamping surfaces of the two clamping arms of the clip, it is preferable to open the clip before covering at least one of the three implant regions with the protective layer. Thus, for example, in the region of the clamping arms, each clamping arm can be uniformly covered on all sides with the protective layer, and then, as described above, an oxide layer can be provided in the second anodizing step.

[0055] Furthermore, the use of one of the above-described methods is proposed for manufacturing medical implants, in particular for manufacturing one of the above-described medical screws or medical clips.

[0056] In this way, medical implants, particularly medical clips, can be colored in a desired manner so that users can distinguish them.

[0057] The following description of preferred embodiments of the present invention may be useful in conjunction with the drawings for further explanation. [Brief explanation of the drawing]

[0058] [Figure 1] A schematic overall perspective view showing one embodiment of an application device having a temporary implant form, which is a medical implant held by an application device. [Figure 2] Plan view showing one embodiment of a temporary implant. [Figure 3] Figure 2 shows the implant from the direction of arrow A. [Figure 4] Plan view showing a further embodiment of the temporary implant. [Figure 5] Figure 4 shows the clip from the direction of arrow B. [Figure 6] Plan view showing a further embodiment of the temporary implant. [Figure 7] Figure 6 shows the implant from the direction of arrow C. [Figure 8] Plan view showing a further embodiment of the temporary implant. [Figure 9] Figure 8 shows the implant from the direction of arrow D. [Figure 10] Plan view showing a further embodiment of the temporary implant. [Figure 11] Figure 10 shows the implant from the direction of arrow E. [Figure 12] Plan view showing a further embodiment of the temporary implant. [Figure 13] A plan view showing one embodiment of a permanent implant corresponding to the temporary implant depicted in Figure 2. [Figure 14] Figure 13 shows the implant from the direction of arrow F. [Figure 15] A plan view showing one embodiment of a permanent implant corresponding to the temporary implant depicted in Figure 4. [Figure 16] Figure 15 shows the implant from the direction of arrow G. [Figure 17] A plan view showing one embodiment of a permanent implant corresponding to the temporary implant depicted in Figure 6. [Figure 18] Figure 17 shows the implant from the direction of arrow H. [Figure 19] A plan view showing one embodiment of a permanent implant corresponding to the temporary implant depicted in Figure 8. [Figure 20] Figure 19 shows the implant from the direction of arrow I. [Figure 21] A plan view showing one embodiment of a permanent implant corresponding to the temporary implant depicted in Figure 10. [Figure 22] Figure 21 shows the implant from the direction of arrow K. [Figure 23] A plan view showing one embodiment of a permanent implant corresponding to the temporary implant depicted in Figure 12. [Figure 24] A schematic diagram showing an implant before anodizing, with two implant regions provided with a protective layer. [Figure 25] Schematic diagram of an implant from Figure 24, having an implant region that is not covered by a protective layer during anodizing and has an oxide layer formed on its surface. [Figure 26] Schematic diagram of the implant from Figure 25, showing the protective layer removed. [Figure 27] Schematic diagram of the implant from Figure 25, as depicted in Figure 24, after forming an oxide layer on the implant area covered with a protective layer before the first anodizing step. [Figure 28] Schematic diagram of the interference effect of a thin oxide layer. [Figure 29] A schematic diagram showing the general structure of a device for forming an anodic oxide layer on an implant. [Modes for carrying out the invention]

[0059] Figure 1 illustrates, as an example, one embodiment of the application device 12, along with one embodiment of the medical implant 10.

[0060] The implant 10 is comprised of a medical clip 14, and the application instrument 12 is comprised of a clip applicator 16.

[0061] The clip applicator 16 is configured in the form of a sliding shaft instrument and comprises two tool elements 18 that form the distal end of the clip applicator 16, and a clip 14 can be housed between the two tool elements 18. Branches 20 that are pivotable relative to each other on the proximal end of the clip applicator 16 allow the shaft 22 to move distally toward the tool elements 18 in order to move the tool elements 18 toward each other. During this movement, the surgical clip is opened, that is, the two end regions of the clamp arms 24 of the clip 14 that are in contact with each other in the basic position schematically depicted in Figure 1 are then moved toward each other.

[0062] The medical clip 14 depicted in Figure 1 is configured in the form of an aneurysm clip 26 for treating aneurysms. The aneurysm clip 26 depicted in Figure 1 is a so-called temporary clip 28. It is provided to temporarily constrict the aneurysm during surgery. Once the shape and size of the permanent clip 30 to be permanently implanted are determined, the surgeon can remove the temporary clip 28 and replace it with the corresponding permanent clip 30 that can remain permanently in the patient's body.

[0063] To distinguish between the temporary clip 28 and the permanent clip 30, they are colored differently.

[0064] The clip 14 includes a biasing element 32 in the form of a coil spring with 1.5 turns, the free end of which is connected to the clamp arm 24.

[0065] A connecting region 34 is formed between the biasing element 32 and the clamp arm 24, where the two clamp arms on one side and the clip portion 36 connecting the free end of the biasing element 32 on the other side intersect.

[0066] The implant 14, schematically depicted in Figure 2, defines a first implant region 38 that defines a first clip region 40, a second implant region 42 that defines a second clip region, and a third implant region 46 that defines a third clip region 48.

[0067] The first clip region 40, which defines the first end region 124, starts from the distal end 50 of the clamp arm 24 and extends toward the proximal end 52 of the implant 10. The second clip region 44, which defines the second end region 126, starts from the proximal end 52 and extends distally. The third clip region 48 extends between the first clip region 40 and the second clip region 44.

[0068] In Figure 2, the clips 14 are depicted in their basic position where the clamp arms 24 are in contact with each other. They can be moved to an open position so that they are separated from each other against the movement of the biasing element 32.

[0069] Clipping regions 40, 44, and 48 are colored. In other words, the described clipping regions 40, 44, and 48 each form a part of the surface of the clip 14 and are colored in different colors.

[0070] In the embodiment depicted in Figure 2, implant regions 38 and 42 are lighter in color than the third implant region 48.

[0071] A first transition region 54 is defined between the first implant region 38 and the third implant region 46, and a second transition region 56 is defined between the second implant region 42 and the third implant region 46. The transition regions 54 and 56 are formed on the first geometrically defined region 58 and the second geometrically defined region 60, respectively. The geometrically defined regions 58 and 60 of the clip 14 are characterized in that the cross-section of the clip 14 is constant or varies over a region length corresponding to at least about 5% of the total length 62 of the clip 14. The geometrically defined region 58 on the clamp arm 24 is characterized by a constant cross-section. The geometrically defined region 60 directly adjacent to the biasing element 32 has a cross-section that expands conically in the direction from the biasing element 32 toward the connecting region 34 and transitions toward the cylindrical portion of the clip 10.

[0072] The three implant regions 38, 42, and 46 are provided with coatings 64, 66, and 68, respectively. The manufacturing and construction of these coatings 64, 66, and 68 are described in more detail below.

[0073] Figures 4 to 12 show different embodiments of the surgical clip 14. These differ only in the shape of the clamp arm 24. Therefore, all embodiments are given the same reference numerals.

[0074] The embodiments shown in Figures 2 and 3 illustrate a double-angle clamp arm 24. Further embodiments of the clip 14 having a double-angle clamp arm, which are slightly longer than those of the embodiments in Figures 2 and 3, are schematically depicted in Figures 4 and 5.

[0075] In the embodiments of the clip 14 shown in Figures 6 and 7, the clamp arm 24 is an elongated arc shape with a relatively large radius of curvature.

[0076] In the embodiments of the clip 14 shown in Figures 8 and 9, the clamp arm 24 is curved in an arc shape, but has a significantly smaller radius of curvature compared to the embodiments shown in Figures 6 and 7.

[0077] The clip embodiments in Figures 10 and 11 show a linearly extending clamp arm 24.

[0078] The clamp arm of the embodiment of clip 14 depicted in Figure 12 also extends linearly, but it is significantly longer than that of the embodiments in Figures 10 and 11.

[0079] Figures 1 to 12 show the temporary clip 28.

[0080] The embodiments of the permanent clip 30 depicted in Figures 13 to 23 correspond to the shapes and sizes of the respective corresponding embodiments of the temporary clip 28 in Figures 2 to 12. However, their coloring differs from that of the temporary clip 28. All embodiments of the permanent clip schematically depicted in Figures 13 to 23 are single-colored. They are colored in a single color corresponding to the coloring of the third implant area 46 of the temporary clip 28. As a result, a simple association between the temporary clip 28 and the corresponding permanent clip 30 is possible.

[0081] The different shapes and sizes of the permanent clips in Figures 13 and 14, 15 and 16, 17 and 18, 19 and 20, 21 and 22, and 23 are colored in an optional manner. For example, one embodiment may be green, another blue, a further embodiment yellow, a further embodiment red, and a further embodiment purple. Correspondingly, the third implant area 16 or third clip area 48 of the temporary clip 28 is colored in that case to correspond to the permanent clip 30 of the same design and size.

[0082] In the case of a temporary clip 28, the first clip area 40 and the second clip area 44 are colored differently from the third clip area 48 in order to ensure that the temporary clip 28 can be clearly distinguished from the permanent clip 30.

[0083] In the embodiments depicted in Figures 1 to 12, the first and second clip regions 40, 44 are colored yellow or gold. Therefore, they are significantly lighter in color than the third implant region 46 or the third clip region 48. Thus, the user can still reliably distinguish the temporary clip 28 from the permanent clip 30, for example, when the temporary clip 28 is held using the clip applicator 16 schematically depicted in Figure 1, and the biasing element 32 is not very visible or not visible at all.

[0084] However, the first implant area 38 of the temporary clip 28 is easily visible, even under a microscope, so that the user can immediately recognize whether they are handling a temporary clip 28 or a permanent clip 30, especially in minimally invasive surgical procedures.

[0085] Both the permanent clip 30 and clip regions 40, 44, and 48 of the described embodiment, as well as the temporary clip 28 depicted in the figure, are formed by anodizing in the depicted embodiment.

[0086] For this purpose, first, each clip 28 or 30 used in the embodiment, which is formed of a biocompatible metal, i.e., titanium, aluminum, or tantalum, is configured in a desired form as illustrated in Figures 2 to 23 as an example.

[0087] In an alternative embodiment, each clip 28, 30 is formed from a metal alloy containing cobalt and / or chromium and / or nickel.

[0088] In one embodiment, the clip is made by Phynox.

[0089] For example, for anodizable materials such as titanium, aluminum, and tantalum, a coating device 72 as schematically depicted in Figure 29 may be used. The coating device 72 comprises a DC voltage source 74 and an electrolytic cell 76 filled with an electrolyte 78 in the form of a dilute acid.

[0090] The implant 10 to be coated is introduced into the electrolyte 78 so that it is completely surrounded by the electrolyte 78.

[0091] The implant 10 is connected to the positive electrode 80, i.e., the anode, of the DC voltage source 74, and the anodic oxidation voltage 82 is set by the potentiometer 84. In the embodiment of the coating device 72 depicted in Figure 29, a container 86 containing an electrolyte 78 conductively connected to the negative electrode 88, i.e., the cathode, of the DC voltage source 74 serves as the counter electrode.

[0092] With the coating device 72, the embodiment of the permanent clip 30 depicted in Figures 13 to 23 is provided with an oxide layer in one single anodic oxidation step. For this purpose, the anodic oxidation voltage 82 is specified by a potentiometer 84 according to the desired coloring. The permanent clip is fully immersed in the electrolyte 78 as described and conductively connected to the anode of the DC voltage source 74. Then, according to the anodic oxidation voltage 82, the oxide layer is colored to the desired color, for example, any spectral color such as green, blue, purple, red, or yellow.

[0093] To form the colored coatings 90 on the implant regions 38, 42, and 46 of the embodiment of the temporary clip 28 depicted in Figures 2 to 12, we proceed as described in more detail with reference to Figures 24 to 27.

[0094] In the first step, in order to provide the coating 90 to the third implant region 46, the first and second implant regions 38 and 40 are first provided with their respective protective coatings 96 and 98, which completely cover the implant regions 38 and 42, respectively. At this time, only the third implant region 46 remains uncoated.

[0095] When the implant 10, partially covered with protective layers 96 and 98, is introduced into the electrolytic cell 76 as described above, the coating 90 can be formed by applying a first anodic oxidation voltage U1.

[0096] The coating is formed to a thickness of 100. The coating completely covers the third implant region 46. Such a coating 90 in the form of such an oxide layer 102 is not possible in the second and third implant regions 42 and 46 because they are covered by protective layers 96 and 98 and thereby passivated.

[0097] In order to also provide coatings 92 and 94 to implant regions 42 and 46, respectively, the protective layers 96 and 98 are first removed. The implant 10 thus prepared is schematically depicted in Figure 26. Coating 90 is provided only to the third implant region 46.

[0098] The implant 10 prepared in this manner is then immersed in an electrolytic cell 76 and connected to the positive electrode 80 of a DC voltage source 74, and a second anodic oxidation voltage U2, which is lower than the first anodic oxidation voltage U1, is applied. At this point, oxide layers 104 and 106 are also formed on the implant regions 38 and 42. Due to the lower anodic oxidation voltage U2, the oxide layer 102 that has already been formed is not further modified by this second oxidation step.

[0099] Each of the oxide layers 104 and 106 has a thickness of 108.

[0100] All embodiments of the temporary clip 28 described above, as depicted in Figures 2 to 12, can be formed in the manner described above using clip regions 40, 44, and 48 of three different colorings. As already stated, the association between the corresponding permanent clip 30 and the temporary clip 28 is brought about by at least one identical configuration of three implant regions 38, 42, and 46 having a coating 90 corresponding to the coating 90 of the permanent clip 30.

[0101] Coatings 90, 92, and 94 have a thickness of 100 or 108 in the range of about 10 nm to about 500 nm. In embodiments, this range is about 20 nm to about 200 nm.

[0102] The coloration of the oxide layers 102-106 formed as described above will be discussed below in relation to Figure 28.

[0103] Figure 28 schematically depicts the oxide layer 90, which is formed on the anodizable material 110 that forms the implant 10.

[0104] The incident light 112 is partially reflected at the incident point 114 on the oxide layer 90 and deflected as a wavefront 116 at a reflection angle α corresponding to the incident angle α of the light 112 on the oxide layer.

[0105] A portion of the light 112 penetrates into the coating 90 and is split perpendicularly in this optically denser medium. At point 118, i.e., the interface between the coating 90 and the material 110, the total internal reflection of the wavefront 120 occurs in the optically denser medium and then exits the coating 90 and exit point 122. The two wavefronts 116 and 120 overlap interferentially, resulting in different colorations of the coating 90 depending on the type and thickness 100 of the coating 90.

[0106] If the implant 10 is not made of an oxidizable material, the coating can also be achieved by an immersion process. For example, in an embodiment of the implant 10, the first and second implant regions 38 and 42 are provided with a gold coating by immersion coating. The third implant region 46 is either left uncoated or has a different coating of a different color than the gold coating applied before the coating of the first and second implant regions 38 and 42. In this case, the permanent clip 30, schematically depicted in Figures 13 to 23, is made of the same material as the temporary clip 28, and is now provided with a coating 90 corresponding to the coating 90 on the third implant region 46 of the temporary clip 28.

[0107] In a further embodiment, the coating process described in relation to Figures 24 to 27 is implemented in reverse. In this case, first, the third implant region 46 is covered with a protective layer 96 or 98, and the first and second implant regions 38 and 42 defining the first and second end regions 124 and 126 are provided with coatings 92 and 94, respectively, by anodizing. In the next step, the protective layer 96 on the third implant region 46 is removed, and the implant 10 is anodized again, but with a lower anodizing voltage U2.

[0108] The described medical clip system 70 comprises at least two medical clips 14, of which at least one clip 14 is configured in the form of a permanent clip 30, and at least one clip 14 is configured in the form of a temporary clip 28. The shape of the temporary clip 28 corresponds to the shape and size of the permanent clip 30. The association between the temporary clip 28 and the permanent clip 30 is achieved by the temporary clip 28 having a clip area 48 colored in the color corresponding to the permanent clip 30, as described above.

[0109] Embodiments of a medical implant 10 in the form of a clip 14 will be described with reference to Figures 1 to 23.

[0110] The colored design on the surface of implant 10 is also used to identify corresponding embodiments of temporary and permanent implants configured in the form of screws. Implant regions, for example, a third implant region 46, may be used to identify and code these screws, in particular, their thickness, length, or respective screw types.

[0111] The association between the color of implant 10 and its respective characteristics can be freely selected during the manufacturing of implant 10. [Explanation of Symbols]

[0112] 10 Implants 12 Application Devices 14 clips 16 Clip Appliers 18 Tool Elements 20 Branches 22 shafts 24 Clamp Arms 26 Aneurysm clip 28 Temporary Clips 30 Permanent Clips 32 biasing factors 34 Consolidation area 36 Clip section 38. First Implant Area 40 First clipping area 42. Second Implant Area 44 Second clipping area 46. ​​The third implant area 48 Third clipping area 50 Distal end 52 Proximal end 54. First Transition Zone 56. Second Transition Zone 58 The first geometrically defined region 60. Second geometrically defined region 62 total length 64 Coating 66 Coating 68 Coating 70 Medical Clip System 72 Coating Devices 74 DC voltage source 76 electrolytic cells 78 Electrolytes 90 Positive pole (anode) 82 Anodizing Voltage 84. Potentiometer 86 Container 88 Negative electrode (cathode) 90 Coating 92 Coating 94 Coating 96 Protective layer 98 Protective layer 100 thickness 102 Oxide layer 104 Oxide layer 106 Oxide layer 108 Thickness 110 Material 112 light 114 Point of incidence 116 wavefront 118 points 120 wavefronts 122 Exit point 124 First edge region 126 Second end region

Claims

1. In particular, a medical clip (14) in the form of an aneurysm clip (26), Two clamp arms (24) and The biasing element (32) and Equipped with, In either case, one clamp arm (24) is positioned or formed on the free end of the biasing element (32), The two clamp arms (24) are in contact with each other in their basic position and are movable to an open position so as to move away from each other against the movement of the biasing element (32). At least a portion of the surface of the clip (14) is colored. In a medical clip (14), The clip (14) defines at least three spatially separated clip regions (40, 44, 48), and adjacent clip regions (40, 44, 48) within these three clip regions (40, 44, 48) are colored in different colors. Characterized by, Medical clip (14).

2. At least two of the three clipping regions (40, 44, 48) are colored the same color, and these at least two clipping regions (40, 44, 48) are not directly adjacent to each other. Characterized by, The medical clip according to claim 1.

3. The first clip region (40) of the at least three clip regions (40, 44, 48) comprises the free ends of the two clamp arms (24), the second clip region (44) of the at least three clip regions (40, 44, 48) comprises the biasing element (32) or a part of the biasing element (32), and at least one third clip region (48) of the at least three clip regions (40, 44, 48) is arranged or formed between the first clip region (40) and the second clip region (44). In particular, the first clipping region (40) and the second clipping region (44) are lighter in color than the at least one third clipping region (48). Characterized by, A medical clip according to claim 1 or 2.

4. At least one of the three clipping regions (40, 44, 48) is colored green, blue, purple, yellow, or gold. In particular, the surface of at least one third clip region (48) is yellow or gold in color, or the surfaces of the first clip region (40) and the second clip region (44) are yellow or gold in color. Characterized by, A medical clip according to any one of claims 1 to 3.

5. Two adjacent clip regions (40, 44, 48) of the at least three clip regions (40, 44, 48) define a colored transition region (54, 56) on the surface, and the colored transition region (54, 46) is positioned or formed on a geometrically defined region (58, 60) of the clip (14), in particular, in the geometrically defined region (58, 60), the cross-section of the geometrically defined region (58, 60) is constant or tapers conically or widens for a region length corresponding to at least about 5%, particularly about 10%, of the total length (62) of the clip (14). Characterized by, A medical clip according to any one of claims 1 to 4.

6. The surface of at least one of the three clip regions (40, 44, 48), in particular all of the clip regions (40, 44, 48), is colored by a coating (90, 92, 94). Characterized by, A medical clip according to any one of claims 1 to 5.

7. a) The layer thickness (100, 108) of the coating (90, 92, 94) is in the range of approximately 10 nm to approximately 500 nm, and in particular, in the range of approximately 20 nm to approximately 200 nm. and / or b) The coating (64, 66, 68, 90, 92, 94) is composed of oxide layers (102, 104, 106) formed by anodic oxidation, In particular, the oxide layers (102, 104, 106) form an interference filter, and the color effect of the oxide layers (102, 104, 106) depends on the thickness (100, 108) of the oxide layers (102, 104, 106). Characterized by, The medical clip according to claim 6.

8. a) The same coating (64, 66, 68, 90, 92, 94) is provided on the clip regions (40, 44, 48) having surfaces colored in the same color. and / or b) The coating (64, 66, 68, 90, 92, 94) contains gold or is made of gold. In particular, the coatings (64, 66, 68, 90, 92, 94) are configured in the form of immersion coatings. Characterized by, A medical clip according to claim 6 or 7.

9. At least one of the three clip regions (40, 44, 48) is not coated. Characterized by, A medical clip according to any one of claims 1 to 8.

10. The clip (14) is made of a biocompatible metal, particularly titanium, aluminum, tantalum, or a metal alloy. In particular, the metal alloy contains cobalt and / or chromium and / or nickel. Characterized by, A medical clip according to any one of claims 1 to 9.

11. A medical clip system (70) comprising at least two medical clips (14), wherein at least one clip (14) is configured in the form of a permanent clip (30) having a surface that is particularly fully colored, and at least one clip (14) corresponding to the shape and / or size of the permanent clip (30) is configured in the form of a temporary clip (28), wherein the surface of the temporary clip (28) is configured to correspond at least partially in color to the permanent clip (30) and is at least partially colored for coating as a temporary clip (28), in the medical clip system (70), The temporary clip (28) is configured in the form of a medical clip (14) according to any one of claims 1 to 10. Characterized by, Medical clip system (70).

12. a) The color of the surface of the permanent clip (30) forms the coating of the shape and / or size of the permanent clip (30), and / or b) Each of the at least two medical clips (14) comprises two clamp arms (24) and a biasing element (32), wherein in each case one clamp arm (24) is positioned or formed on the free end of the biasing element (32), and the two clamp arms (24) are in contact with each other in a basic position and are movable to an open position so as to move away from each other against the movement of the biasing element (32). Characterized by, The medical clip system according to claim 11.

13. a) The permanent clip (30) and the temporary clip (28) have the same configuration except for the coloring. and / or b) The clip system (70) comprises at least two permanent clips (28, 30) of different sizes and / or shapes. Characterized by, A medical clip system according to claim 11 or 12.

14. A method for manufacturing a medical implant (10), particularly a medical clip (14) or a medical screw, wherein the implant surface of the medical implant (10) is colored. At least three spatially separated implant regions (38, 42, 46) are defined on the implant (10), and adjacent implant regions (38, 42, 46) of the at least three implant regions (38, 42, 46) are colored in different colors. Characterized by, method.

15. a) At least two of the three implant regions (38, 42, 46) are colored the same color, and these at least two implant regions (38, 42, 46) are not directly adjacent to each other. and / or b) Two adjacent implant regions (38, 42, 46) of the at least three implant regions (38, 42, 46) define a colored transition region (54, 56) on the surface, and the colored transition region (54, 56) is positioned or formed on a geometrically defined region (58, 60) of the implant (10), in particular, in the region (58, 60), the cross-section of the region (58, 60) is constant or tapers conically or widens for a region length corresponding to at least about 5%, particularly about 10%, of the total length (62) of the implant (10). Characterized by, The method according to claim 14.

16. a) At least one of the three implant regions (38, 42, 46) is colored green, blue, purple, yellow, or gold. and / or b) The first implant region (38) of the at least three implant regions (38, 42, 46) is defined by the first end region (124) of the implant (10), the second implant region (42) of the at least three implant regions (38, 42, 46) is defined by the second end region (126) of the implant (10), and at least one third implant region (46) of the at least three implant regions (38, 42, 46) is positioned or formed between the first implant region (38) and the second implant region (38). Characterized by, The method according to claim 14 or 15.

17. a) The first implant region (38) and the second implant region (42) are lighter in color than the at least one third implant region (46). and / or b) The surface of at least one third implant region (46) is yellow or gold in color, or the surfaces of the first implant region (38) and the second clip region (42) are yellow or gold in color. Characterized by, The method according to claim 16.

18. A colored coating (64, 66, 68, 90, 92, 94) is provided on the surface of at least one of the three implant regions (38, 42, 46), particularly on the surface of all implant regions (38, 42, 46). Characterized by, The method according to any one of claims 14 to 17.

19. a) The coating (64, 66, 68, 90, 92, 94) is composed of layers with a thickness (100, 108) in the range of approximately 10 nm to approximately 500 nm, particularly in the range of approximately 20 nm to approximately 200 nm. and / or b) The coating (64, 66, 68, 90, 92, 94) is composed of oxide layers (102, 104, 106) formed by anodizing, and / or c) The same coating (64, 66, 68, 90, 92, 94) is applied to implant regions (38, 42, 46) having surfaces colored in the same color. and / or d) The coating (64, 66, 68, 90, 92, 94) is formed by gold plating, particularly by an immersion process. Characterized by, The method according to claim 18.

20. a) At least one of the three implant regions (38, 42, 46) remains uncoated. and / or b) The implant (10) is made of a biocompatible metal and / or anodizable metal or metal alloy, wherein the metal is titanium, aluminum, or tantalum, or contains them. Characterized by, The method according to any one of claims 14 to 19.

21. The implant (10) is introduced into an electrolyte (78), particularly a dilute acid, and the implant (10) is connected to the anode (80) of a DC voltage source (74), and an anodizing voltage U is applied for the purpose of anodizing. １ , U ２ To receive Characterized by, The method according to claim 19 or 20.

22. a) Different anodizing voltages (U) during the anodizing process to form different colors １ , U ２ ) is applied to the implant (10), and / or b) At least one of the at least three implant regions (38, 42, 46) is covered with a protective layer (96, 98), and the implant (10) is then subjected to a first anodizing voltage U to form a first oxide layer (102) on the surface of the implant (10) that is not covered with the protective layer (96, 98). １ The implant (10) is then anodized to remove the protective layer (96, 98), and then the implant (10) is subjected to a second anodizing voltage U to form a second oxide layer (104, 106) on the surface of the implant (10). ２ It is anodized with the first anodizing voltage U ２ However, the second anodic oxidation voltage U １ Larger than, and in particular, the protective layer (96, 98) is formed by a resin layer, Characterized by, The method according to claim 21.

23. The medical implant (10) is composed of a medical clip (14) or a medical screw, in particular a bone screw or a pedicle screw. Characterized by, The method according to any one of claims 14 to 22.

24. The medical clip (14) is composed of two clamp arms (24) and a biasing element (32), in which case one clamp arm (24) is positioned or formed on the free end of the biasing element (32), and the two clamp arms (24) are in contact with each other in their basic position and are movable to an open position so as to move away from each other against the movement of the biasing element (32). In particular, the clip is opened before covering one of the at least three implant regions (38, 42, 46) with the protective layer (96, 98). Characterized by, The method according to claim 23.

25. Use of the method according to any one of claims 14 to 24 for manufacturing a medical implant (10), and in particular for manufacturing a medical screw or a medical clip (14) according to any one of claims 1 to 10.

Images