DE102021202281A1 - Anchorable Implant Assembly - Google Patents

Abstract

The present invention relates to an anchorable implant (10, 10', 10'', 10''', 10'''') with an implant part (20, 20', 20", 20''', 20'''' ), which can be anchored in the area of a skeletal bone (60) by means of a fastening element (30, 30') with a widened head area; the implant part (20, 20', 20", 20''', 20'''') having a through opening (35, 35', 35", 35''', 35'''') for introducing the fastening element (30, 30') into the skeletal bone (60); the through opening (35, 35', 35" , 35''', 35'''') a widened receiving area (15, 15', 15", 15''', 15'''') for at least partially accommodating the widened head area of the fastening element (30, 30') wherein at least the receiving area (15, 15', 15", 15''', 15'''') of the through-opening (35, 35', 35", 35''', 35'''') at least in certain areas is lined with an elastic damping element (40, 40', 40", 40"', 40"") for supporting the fastening element (30, 30'). The invention also relates to an implant arrangement with an anchorable implant (10, 10', 10", 10''', 10'''') and with at least one fastening element (30, 30') with a widened head area, the fastening element having the through-opening ( 35, 35', 35", 35''', 35"") of the implant part (20, 20', 20", 20''", 20'''') of the anchorable implant reaches through, with the broadened head area of the fastening element ( 30, 30') in the widened receiving area (15, 15', 15", 15"', 15'''') of the through opening (35, 35', 35", 35''", 35'''') at least is partially received, and wherein the elastic damping element is at least partially accommodated between the (head area of) the fastening element(s) (30, 30') and the receiving area (15, 15', 15", 15''', 15''''). (40, 40', 40", 40"', 40"").

Description

The present invention relates to an anchorable implant with an implant part which can be anchored in the area of a skeletal bone by means of a fastening element with a widened head area, the implant part having a through-opening for inserting the fastening element into the skeletal bone. The invention also relates to an implant arrangement with an implant that can be anchored and with at least one fastening element with a widened head area.

When inserting and fixing both absorbable and non-absorbable implants, there is a large number of surgical holding and fixing methods. These include, for example, metallic screws made of titanium, metallic nails or similar pin-shaped fastening elements. In addition, other different instruments such as tongs or tweezers are also used here. In this context, one already knows such an implant and an implant arrangement provided with a fastening element from FIG EP 2632356 B1 .

Due to this fixation technique, a secure and implant-retaining fixation of especially porous and brittle materials can only be realized insufficiently. In addition, there is also the risk of damage to the possibly individual implant/implant part.

There is therefore the task of making available an implant and an implant arrangement provided with this which, with little effort, allows the implant/implant arrangement to be arranged in the region of the relevant skeletal bone with few complications, by means of which a sufficient frictional connection with the implant is ensured there, whereby this gentle application of force takes place.

The object is achieved by an anchorable implant with the features of claim 1. The solution consists in particular in the fact that the implant part of the implant according to the invention has a through-opening for inserting the fastening element into the skeletal bone, the through-opening having a widened receiving area for at least partially receiving the widened head area of the fastening element, and at least the receiving area of the through-opening being at least partially lined with a resilient cushioning member for supporting the enlarged head portion of the fastener. Because of this, implant parts can be made of a resorbable and/or non-resorbable porous and/or brittle material, e.g. ceramic, and the fastening elements or the structure supporting them can be designed in the form of the receiving area, as described in more detail below, to prevent damage. For example, the receiving area as well as the fastening elements themselves can be clad or coated with softer materials. As a result, by using standard fixing elements, e.g. screws or the like, as fastening elements, sufficient frictional locking can be applied to the implant. The necessary frictional connection is gently initiated by the resulting "damping element implant".

By at least partially arranging the elastic damping element on the implant part, the implant and the fastening element are actually decoupled in terms of force and vectorially via an elastic unit on the one hand and a plastic unit on the other hand. Since the damping element, e.g. in the form of a surface modification or coating, is able to compensate for at least one degree of freedom of movement of the implant part and the fastening element relative to one another in the connection direction, the invention in a certain way realizes a kind of self-locking of the fastening; any geometric loosening that may occur due to structural changes can be compensated for

Preferred developments of the implant according to the invention and the implant arrangement according to the invention can be found in the corresponding dependent claims.

In an advantageous development of the implant according to the invention, the receiving area of the through-opening on the implant part can be arranged facing away from the skeletal bone. This makes it possible to also arrange fastening elements on the side of the implant or implant part facing away from the skeletal bone, the head area of which protrudes beyond the volume of the receiving area on this side and, for example, at least partially overlaps its opening at its edge, so that this type of Storage of the head area mentioned can be formed a support with more advantageous load application.

In a further stable and easy-to-handle development of the implant, the implant part can be made of an absorbable or non-absorbable, porous or non-porous material, so that on the one hand the advantage of absorbable implants can be exploited, these not being surgically removed after healing to have to. In addition, a porous implant part can advantageously be loaded with anti-inflammatory agents in order to reduce rejection reactions. The selection of the type of material can also be of importance that should not be underestimated, so that the material dissolves in the body at the right time. If further treatment with removal of the implant part is planned anyway, preference can be given to a non-resorbable component. A further preferred development can then consist in particular in the implant part being made of a ceramic material, in particular calcium phosphate ceramics such as HA/ß- TCP, zirconia (ZrO ₂ ) or the like is formed, with the porosity, for example, promoting rapid ingrowth and seamless ingrowth of the implant part in the surrounding tissue. Furthermore, designs made of β-TCP, ß-TCP/Mg, HA/Mg or other ceramic materials are also conceivable.

In another advantageous embodiment of the implant according to the invention, the damping element can be made of a polymer material that has the necessary damping properties and is easy to process and handle. A polymeric lining of the receiving area also brings with it a high degree of abrasion resistance, which is why the implant part can be used as a drilling template for the skeletal bone, so to speak as a side effect. In general, the damping element can be made in particular from an absorbable material.

In preferred embodiments, the damping element of the implant according to the invention can be made of silicone or polyurethane. A silicone elastomer, for example, has good sealing properties, and you can also take advantage of the good moldability when adapting to the receiving area of the implant part, which is similar to that of a coating. It is characterized by the reproduction of surface details and is practically non-shrinking when cured. The easy handling of components made of thermoplastic urethanes is based on their high elasticity when deformed and are characterized by good shock absorption properties. Three-dimensional components made from it also have a largely smooth surface.

In a further preferred embodiment, the damping element can be designed as a plug-in element that can be detachably inserted into the receiving area. The advantage of this design is that the receiving area can be easily provided with the plug-in element, but this can also be removed or exchanged from the receiving area if necessary, which in turn increases the range of use of the implant part.

In another expedient embodiment of the implant according to the invention, the provision of the damping element designed as a plug-in element is particularly preferred as a sleeve or essentially hollow-cylindrical element, as a result of which the implant can be provided with the damping element in a particularly simple manner and firmly adhering to the receiving area. The plug-in element is used for the simple introduction of a fastening element and also reduces the pressure load on the implant part. The term "essentially hollow-cylindrical" refers primarily to the inner cross-section of the damping element, but depending on the implant part, its outer contour can also be essentially cylindrical, which includes deviations within certain limits. Of course, other shapes of the plug-in element are also conceivable.

A damping element can be provided on the implant according to the invention in a particularly simple and easy-to-handle manner if it forms a coating on the receiving area at least in certain areas, as a result of which a firmly adhering layer of a per se shapeless material is applied to the possibly structured surface of the receiving area is, depending on the application, different layer thicknesses can be useful. The layer in question can be applied by thermal and/or mechanical and chemical processes. In addition, a pretreatment of the receiving area as the substrate of the coating, as well as the provision of an adhesion promoter (primer) may be necessary.

In another expedient embodiment of the implant according to the invention, the damping element can be designed as a one-piece surface structure of the receiving area. Such a very durable structure can already be provided during the manufacture of the implant part and can be used immediately after it has been created. It is equally conceivable to subsequently introduce the structure into the implant part by machining.

In order to be able to safely avoid an unintentional detachment of a fastening element from the implant part, in a further embodiment of the implant a holding means for fixing the fastening element can be provided on a surface of the through opening of the implant part, which means detaching the fastening elements from the recording area can counteract. The fastening element can be held loss-proof in a simple manner on the receiving area by the holding means. Particularly preferably, the holding means can be designed as a thread or as a latching projection on which the fastening element is screwed or latched to the receiving area. For example, in the form of a coating, the damping element can then still be arranged between the receiving area of the through-opening and the fastening element.

In preferred dimensions of embodiments of the implant, the damping element has a thickness in a range between 1 nanometer (nm) and 10 ⁴ nm, particularly preferably these are between 1 nm - 50 nm, 50 nm - 100 nm, 100 nm - 500 nm, 500 nm - 999 nm, 999 nm - 10000nm, 10mm - 25mm, 20mm - 45mm, 45mm -100mm, 100mm - 200mm, 200mm - 1mm.

The above object is also achieved by an implant arrangement with an anchorable implant, in particular one as described above, and with at least one fastening element with a widened head region, the fastening element reaching through the through-opening of the implant part of the anchorable implant, the widened head region of the fastening element in the widened The receiving region of the through-opening is at least partially received, and the elastic damping element is arranged at least in regions between the fastening element and the receiving region. The fastening element reliably holds the implant part on the skeletal bone, with the damping element between the receiving area of the implant part and the fastening element on the one hand applying a sufficient frictional connection to the implant with gentle application of force, and on the other hand self-locking being realized due to the force-technical decoupling between them.

An advantageous embodiment of the implant arrangement can consist in the holding means being designed as part of an engagement with the at least one fastening element, in particular as a plurality of thread turns or as a locking projection, so that a connection with a defined holding force that cannot be released unintentionally is formed between the implant part and the skeletal bone can be reached. Accordingly, the fastening element is held by the holding means on the implant part with the damping element, and the holding means counteracts a loosening of the fastening element from the receiving area of the through-opening.

In an expedient embodiment of the implant arrangement according to the invention, the fastening element can be designed as a screw, nail or pin, as a result of which a stable connection between the implant part and the skeletal bone is realized.

In a further embodiment of the invention, the at least one fastening element can preferably be formed from a metallic material, in particular from titanium and/or a titanium alloy, which has a high level of compatibility in human tissue.

The above configurations and developments can be combined with one another as desired, insofar as this makes sense. Further possible refinements, developments and implementations of the invention also include combinations of features of the invention described above or below with regard to the exemplary embodiments that are not explicitly mentioned.

• 1 eine perspektivische Seitenansicht einer ersten erfindungsgemäßen Ausführungsform einer Implantatanordnung mit an einem Skelettknochen verankerbarem Implantat sowie einem Befestigungselement;
• 2 eine perspektivische Seitenansicht einer zweiten Ausführungsform der Implantatanordnung mit an einem Skelettknochen verankerbarem Implantat sowie einem Befestigungselement;
• 3 eine perspektivische Seitenansicht einer dritten Ausführungsform eines verankerbaren Implantats mit einer Durchgangsöffnung und einem Aufnahmebereich, wobei der Aufnahmebereich zumindest teilweise mit einem Dämpfungselement ausgekleidet ist;
• 4 eine perspektivische Seitenansicht einer vierten Ausführungsform eines verankerbaren Implantats mit einer Durchgangsöffnung und einem Aufnahmebereich, wobei der Aufnahmebereich zumindest teilweise mit einem Dämpfungselement ausgekleidet ist; und
• 5 eine perspektivische Seitenansicht einer fünften Ausführungsform eines verankerbaren Implantats mit einer Durchgangsöffnung und einem Aufnahmebereich, wobei der Aufnahmebereich zumindest teilweise mit einem Dämpfungselement ausgekleidet ist.

The invention is explained in more detail below using exemplary embodiments in the figures of the drawing. The following are shown in a partially schematic representation:

• 1 a perspective side view of a first embodiment of an implant arrangement according to the invention with an implant that can be anchored to a skeletal bone and a fastening element;
• 2 a perspective side view of a second embodiment of the implant arrangement with an implant that can be anchored to a skeletal bone and a fastening element;
• 3 a perspective side view of a third embodiment of an anchorable implant with a through opening and a receiving area, wherein the receiving area is at least partially lined with a damping element;
• 4 a perspective side view of a fourth embodiment of an anchorable implant with a through opening and a receiving area, wherein the receiving area is at least partially lined with a damping element; and
• 5 a perspective side view of a fifth embodiment of an anchorable implant with a through opening and a receiving area, wherein the receiving area is at least partially lined with a damping element.

In all figures are the same or functionally identical elements and devices - if unless otherwise indicated - have been provided with the same reference numbers.

1 shows a perspective side view of a first embodiment of an implant arrangement according to the invention with an implant that can be anchored to a skeletal bone and with a fastening element.

In the 1 one recognizes an implant arrangement denoted as a whole by 100, in which the anchorable implant 10 is anchored to an implant part 20 made of a resorbable porous material in the area of a skeletal bone 60 by means of a fastening element 30 with a widened head area. For this purpose, the implant part 20 initially has a through-opening 35 for inserting the fastening element 30 into the skeletal bone 60, which extends through the implant part 20 transversely to the longitudinal extent of the latter, the through-opening 35 being provided with a widened receiving region 15 which contains the widened head region of the fastening element 30 partially absorbs. The receiving area 15 of the through-opening 35 is also partially lined with an elastic damping element 40 for supporting the widened head area of the fastening element 30 . The part of the receiving area 15 of the through opening 35 of the implant part 20 accommodating the head area of the fastening element 30 is arranged facing away from the skeletal bone 60 .

The fastening element 30 designed as a titanium screw is held by a holding means 50 on the implant part 20 with the damping element 40, which in turn is arranged between the through-opening 35 and the fastening element. The holding means 50 counteracts a loosening of the fastening element 40 from the receiving area 15 of the through-opening 35 . The fastening element 30 forms an engagement 70 with the threads of the holding means 50 of the implant part 20, the fastening element 30 reaching completely through the through opening 35 and engaging in a bore 62 of the skeletal bone. The thread of the holding means 50 of the implant part 20 continues in the bore 62 of the skeletal bone 60 .

The implant arrangement 100 shown allows an implant part 20 to be arranged in the region of the relevant skeletal bone 60 with little effort thanks to the fastening element 30. The fastening element 30 ensures a sufficient frictional connection with the implant 10, with the implant 20 being gently introduced.

the 2 shows a perspective side view of a second embodiment of the implant arrangement 100' with an implant 10' that can be anchored to a skeletal bone 60' and a fastening element 30'. This embodiment has strong resemblance to that of FIG 1 However, two fastening elements 30' can be seen here, each of which extends through a through-opening 35' on the implant part 20'. Again, the respective through-opening 35' is provided with a widened receiving area 15' for at least partially receiving the widened head area of the fastening element 30' and the receiving area 15' of the respective through-opening 35' is at least partially provided with an elastic damping element 40' for supporting the fastening element 30'. lined

In contrast to the implant arrangement 100 from the 1 is with the one from the 2 Fastening element 30' is embodied as a pin made of a stable and within limits flexible plastic material, while retaining means 50' is embodied as part of an engagement with the at least one fastening element 30', here as a latching projection, so that pin-like fastening element 30' in the 2 the implant part 20' of the implant 10' held there securely on the skeletal bone 60'. In the 2 the fastening element 30' is in engagement with a plurality of latching projections, since a further latching projection 52' is introduced into the bore 62' of the skeletal bone 60'. The fastening element 30' is thus locked on the one hand on the implant part 20' of the implant 10' and on the other hand on the skeletal bone 60' and is thus fixed.

the 3 until 5 only show the implant 10', 10'', 10''' below, and do not show the skeletal bone and the attachment to it by means of the attachment element, since the implant 10', 10'', 10''' itself is also shown solves the task.

the 3 shows a perspective side view of a third embodiment of an anchorable implant 10'', which is provided with through openings 35'' and receiving areas 15'', the receiving area 15'' being lined with a damping element 40'' in each case. The implant part 20'' of the implant 10'' is made porous and resorbable with an HA/D-TCP as the ceramic material. In this case, the damping element 40'' is designed as a coating over the entire area of the receiving area 15''.

the 4 shows a perspective side view of a fourth embodiment of an anchorable implant 10''', which is provided with through openings 35''' and receiving areas 15''', the receiving area 15''' being lined with a damping element 40''' in each case. In contrast to the embodiment of 3 Here the damping elements 40''' are made of a polymer material, at the same time the damping elements 40''' are each embodied as plug-in elements that can be detachably inserted into the receiving areas 15'''. The plug-in elements designed as a sleeve each have an internal thread which continues a thread-like holding means 50''' on the implant part 20''' in the longitudinal direction of the through-opening 35'''.

the 5 shows a perspective side view of a fifth embodiment of an anchorable implant 10'''', which is provided with through openings 35'''' and receiving areas 15'''', wherein the receiving areas 15'''' each have a damping element 40''' are lined. In this embodiment, in contrast to those from the 3 and 4 the damping elements 40'''' are each formed as a one-piece surface structure of the respective receiving area 15'''' of the implant part 20''''.

Although the present invention has been described above on the basis of preferred exemplary embodiments, it is not limited thereto but can be modified in a variety of ways. In particular, the invention can be changed or modified in many ways without departing from the essence of the invention.

QUOTES INCLUDED IN DESCRIPTION

This list of documents cited by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Patent Literature Cited

• EP 2632356 B1 [0002]

Claims (19)

Anchorable implant (10, 10', 10'', 10''', 10'''') with: an implant part (20, 20', 20'', 20''', 20''''), which can be anchored in the area of a skeletal bone (60) by means of a fastening element (30, 30') with a widened head area, wherein the implant part (20, 20', 20'', 20''', 20'''') has a through-opening (35, 35', 35'', 35''', 35'''') for inserting the fastening element (30, 30') in the skeletal bones (60), wherein the passage opening (35, 35', 35'', 35''', 35'''') has an expanded receiving area (15, 15', 15'', 15''', 15'''') for at least partially receiving the widened head region of the fastening element (30, 30'), at least the receiving area (15, 15', 15'', 15''', 15'''') of the through-opening (35, 35', 35'', 35''', 35'''') at least in certain areas is lined with an elastic cushioning element (40, 40', 40'', 40''', 40'''') for supporting the widened head region of the fastening element (30, 30'). Implant (10, 10', 10'', 10''', 10'''') after claim 1 , wherein the receiving area (15, 15', 15'', 15'''15'''') of the through opening (35, 35', 35'', 35''', 35'''') on the implant part (20, 20', 20'', 20''', 20'''') facing away from the skeletal bone. Implant (10, 10', 10'', 10''', 10'''') according to one of Claims 1 or 2 , wherein the implant part (20, 20', 20'', 20''', 20'''') is formed from an absorbable or non-absorbable, porous or non-porous material. Implant (10, 10', 10'', 10''', 10'''') according to one of the preceding claims, wherein the implant part (20, 20', 20'', 20''', 20''' ') is formed from a ceramic material, in particular from β-TCP, HA/□-TCP, β-TCP/Mg, HA/Mg or zirconia. Implant (10, 10', 10'', 10''', 10'''') according to one of the preceding claims, wherein the damping element (40, 40', 40'', 40''', 40''' ') is formed from a polymeric material. Implant (10, 10', 10'', 10''', 10'''') after claim 5 , wherein the damping element (40, 40', 40'', 40''', 40'''') is formed from silicone or polyurethane. Implant (10, 10', 10'', 10''', 10'''') according to one of the preceding claims, wherein the damping element (40, 40', 40'', 40''', 40''' ') is designed as a plug-in element that can be releasably inserted into the receiving area (15, 15', 15'', 15''', 15''''). Implant (10, 10', 10'', 10''', 10'''') after claim 7 , wherein the damping element (40, 40', 40'', 40''', 40'''') designed as a plug-in element is provided as a sleeve or essentially as a hollow-cylindrical element. Implant after one of Claims 1 until 6 , wherein the damping element (40, 40', 40'', 40''', 40'''') on the receiving area (15, 15', 15'', 15''', 15'''') at least partially forms a coating. Implant after one of Claims 1 until 6 , wherein the damping element (40, 40', 40'', 40''', 40'''') as an integrally formed surface structure of the receiving area (15, 15', 15'', 15''', 15'''') is trained. Implant according to one of the preceding claims, wherein on a surface of the through opening (35, 35', 35'', 35''', 35'''') of the implant part (20, 20', 20'', 20''' , 20'''') a holding means (50, 50', 50'', 50''', 50'''') for fixing the fastening element (30, 30') is provided. implant after claim 11 , wherein the holding means (50, 50', 50'', 50''', 50'''') is designed as a thread or as a locking projection. Implant according to one of the preceding claims, wherein the damping element (40, 40', 40'', 40''', 40'''') has a thickness in a range between 1 nm and 1 mm. implant after Claim 14 , where the thickness of the damping element (40, 40', 40'', 40''', 40''''), between 1nm - 50nm, 50nm - 100nm, 100nm - 500nm, 500nm - 999nm, 999nm - 10000nm, 10mm - 25mm, 20mm - 45mm, 45mm -100mm, 100mm - 200mm, 200mm - 1mm lies. Implant arrangement (100, 100') with an anchorable implant (10, 10', 10'', 10''', 10'''), in particular an implant according to one of the preceding claims (10, 10', 10'', 10''', 10''''), with an implant part (20, 20', 20'', 20''', 20'''') which is fixed in the area of a skeletal bone (60) by means of a fastening element (30 , 30') can be anchored with a widened head area, the implant part (20, 20', 20", 20"', 20"") having a through opening (35, 35', 35", 35"', 35"") for inserting the fastening element (30, 30') into the skeletal bone (60), the through-opening (35, 35', 35'', 35''', 35"") having a widened receiving area (15, 15', 15 ", 15''', 15'''') for at least partially receiving the widened head area of the fastening element (30, 30'), wherein at least the receiving area (15, 15', 15", 15"', 15"" ) the through opening (35, 35', 35", 35"', 35''") is lined at least in regions with an elastic damping element (40, 40', 40", 40''', 40'''') for supporting the widened head region of the fastening element (30, 30'), and with at least one Fastening element (30, 30') with a broadened head area, the fastening element penetrating the through opening (35, 35', 35", 35''', 35'''') of the implant part (20, 20', 20", 20''',20"") of the anchorable implant reaches through, the widened head area of the fastening element (30, 30') in the widened receiving area (15, 15', 15'', 15''', 15'''') of the through-opening (35, 35', 35", 35''', 35'''') is at least partially received, and wherein between the widened head area of the fastening element (30, 30') and the receiving area (15, 15', 15" , 15''', 15'''') the elastic damping element (40, 40', 40", 40''', 40'''') is arranged at least in regions. Implant arrangement (100, 100 ') after claim 15 , wherein the fastening element (30, 30') is attached to the damping element (40, 40', 40", 40"', 40'''') of the implant part and the holding means (50, 50', 50", 50''', 50'''') prevent the fastening element (30, 30') from being released from the receiving area (15, 15 ', 15'', 15''', 15''') counteracts the through opening (35, 35', 35'', 35''', 35''''). Implant arrangement (100, 100 ') after Claim 16 , wherein the at least one fastening element (30, 30') is connected to the holding means (50, 50', 50", 50''', 50'''') of the implant part (20, 20', 20'', 20''',20"") forms at least one engagement (70, 70'). Implant arrangement (100, 100') according to one of the preceding claims, wherein the at least one fastening element (30, 30') is designed as a screw, nail or pin. Implant arrangement (100, 100 ') after Claim 18 , wherein the at least one fastening element (30, 30 ') is formed from a metallic material, in particular from titanium and / or a titanium alloy.

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