Fixator for restraining a first bone with respect to a second bone or a soft tissue
Patent Information
- Application Number
- PCT/EP2026/058334
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2025-03-27
- Filing Date
- 2026-03-24
- Publication Date
- 2026-10-01
Smart Images
Figure EP2026058334_01102026_PF_FP_ABST
Abstract
Description
[0001] P29243PC00 24.03.2026
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[0003] Fixator for restraining a first bone with respect to a second bone or a soft tissue
[0004] FIELD OF THE DISCLOSURE
[0005] This disclosure relates to a fixator for restraining a first bone with respect to a second bone or a soft tissue.
[0006] BACKGROUND OF THE DISCLOSURE
[0007] The musculoskeletal system is crucial for providing stability and support for the body, and for allowing movement of the body. It is made up of bones, muscles, cartilage, tendons, ligaments, joints and other connective tissue. Several different injuries affect the musculoskeletal system and a variety of implants and interventions have been reported to treat different classes of these injuries. Many interventions rely on implants that serve to reinforce or replace parts of the musculoskeletal system. For example, synthetic tissue may be used to replace an injured portion of the natural connective tissue.
[0008] However, the known implants suffer from a range of disadvantages. For example, some of the known implants display poor load-bearing properties both upon implantation and over time. These challenges apply in particular to those implants which have primarily been developed towards good biocompatibility. In many cases, the implants are limited in their load-bearing properties. A further challenge is the ability to maintain the loadbearing properties over time. As an example, many of the known implants suffer from creep, which may lead to loss of a pre-applied tension.
[0009] On the other hand, many of the implants which were primarily developed to ensure good load-bearing properties (e.g. high tensile strength) suffer from poor biocompatibility. AsP29243PC00 24.03.2026
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[0011] an example, several polymeric scaffolds have been developed to ensure high tensile strength, e.g. due to a combination of using tensile strength materials and constructs. However, many of the known implants only display poor cellular in-growth of adjacent tissue into the implant over time.
[0012] A further challenge arises in the context of implants which contact a bone surface for load transfer. For example, some known implants form a semi-loop around a given bone, e.g. to connect the bone to another bone or to soft tissue, or in the context of cerclage applications. A major challenge with these implants is efficient and balanced load transfer between the bone and the implant, including a smooth initiation of load transfer.
[0013] In conclusion, there is a need to improve the known implants for fixating bones and / or soft tissue with respect to each other.
[0014] SUMMARY OF THE DISCLOSURE
[0015] It is a general object of the present disclosure to provide a fixator for restraining a first bone with respect to a second bone or a soft tissue, which fixator addresses at least some of the disadvantages known from the prior art. For example, the fixator may be used for soft tissue reconstruction or replacement, e.g. ligament and / or tendon reconstruction or replacement. In at least some embodiments, it is an object to provide a fixator with good load-bearing properties and good biocompatibility. Preferably, the fixator would display high tensile strength while also allowing in-growth of adjacent tissue. Furthermore, it is an object in at least some embodiments to provide a fixator whose loadbearing properties can be tailored. Furthermore, it is an object in at least some embodiments to provide a fixator which rests on a surface of a first bone and which is able to smoothly and effectively transfer loads from the first bone to another biological structure,P29243PC00 24.03.2026
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[0017] e.g. another bone and / or soft tissue. In particular, it would be desirable to improve initiation of load transfer and long-term load transfer. Furthermore, the fixator would ideally be easily implantable for a surgeon and / or easy to manufacture.
[0018] The general object is achieved by the subject-matter of the independent claims. Further favorable embodiments follow from the dependent claims and the overall disclosure.
[0019] According to the present disclosure, a fixator is provided. The fixator can for example be used for restraining a first bone with respect to a second bone or a soft tissue.
[0020] The fixator provided herein comprises a strap-like load-bearing element extending in a longitudinal direction from a first end to a second end. The load-bearing element comprising a first tensile membrane for load transfer between the first end and the second end of the load-bearing element. The first tensile membrane extends in the longitudinal direction and in a transversal direction orthogonal to the longitudinal direction and comprises at least one outer side. Furthermore, said at least one outer side is in interaction with a first bioactive material for interaction with a surrounding tissue in a patient’s body.
[0021] An advantage of the fixator described herein is that it combines load-bearing capabilities with biocompatibility. In particular, the first tensile membrane may be used to impart stability and ensure load transfer between the first end and the second end. Furthermore, because the outer side of the first tensile membrane is in interaction with the first bioactive material, the first bioactive material may e.g. be used for in-growth of adjacent soft tissue. As an illustrative example of the fixator described herein, the first tensile membrane may e.g. form a tubular structure which is filled with the first bioactive material and also coated with the first or a second bioactive material. The tubularly shaped first tensile membrane may then e.g. be used for being connected on opposite ends with two bonesP29243PC00 24.03.2026
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[0023] for interconnecting the bones at a pre-tension, e.g. to replace or support a severed ligament. The first bioactive material may be used to promote tissue in-growth over time. Thus, for example, the first bioactive material may provide a scaffold for cellular ingrowth.
[0024] A further advantage is that the load-bearing capabilities can be maintained over time. For example, at least in some embodiments, the first tensile membrane may initially be used for load transfer post-implantation. Over time, the adjacent tissue may increasingly grow into the fixator, such that the resulting in-grown tissue can increasingly contribute to load transfer as well. This is advantageous for compensating changes that might otherwise occur e.g. due to creep of the first tensile membrane over time.
[0025] Lastly, a further advantage of the fixator is that its load-bearing properties and its biological properties can be tailored to a given application. For example, the tensile strength profile over time can be adjusted by choosing the first tensile membrane and the first bioactive material and their arrangement accordingly. This makes the fixator particularly useful for tissue reconstruction applications, such as for ligament or tendon reconstruction.
[0026] The fixator comprises a first tensile membrane for load transfer between the first end and the second end. The first tensile membrane extends in the longitudinal direction and in a transversal direction orthogonal to the longitudinal direction. It is understood that the longitudinal direction is a main direction of extension of the strap-like load-bearing element. The transversal direction may also be a main direction of extension of the straplike load-bearing element.
[0027] For example, the first tensile membrane may e.g. extend along a plane defined by the longitudinal direction and by the transversal direction. However, in some embodiments,P29243PC00 24.03.2026
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[0029] the first tensile membrane is tubular. In these embodiments, the longitudinal direction may be a linear direction extending along a length of the tubular first tensile membrane, and the transversal direction may be a rotational direction orthogonal to the longitudinal direction and following the tubular shape of the first tensile membrane. In other words, in these embodiments, the transversal direction may correspond to a circumferential direction.
[0030] Depending on the application, different first tensile membranes may be used. In principle, the first tensile membrane could be closed. However, it is particularly advantageous to use a first tensile membrane which is porous and / or grid-shaped. One advantage of these embodiments is that they allow in-growth of surrounding tissue. For example, surrounding connecting tissue may proliferate into the first bioactive material over time, thereby allowing tissue regeneration and establishing a strong fixation over time. For example, the first tensile membrane may be porous and may optionally comprise a plurality of pores having a pore size of at least 0.001 mm2, such as from 0.01 mm2to 100 mm2, preferably from 0.1 mm2to 25 mm2. Irrespective of the specific pore size, the pores may for example be randomly distributed across the outer side of the first tensile membrane, or they may be arranged regularly across the outer side of the first tensile membrane. In some embodiments, the pores are arranged at least in the region of the one or more load-bearing surfaces, as described further below.
[0031] Depending on the application, different materials and constructs may be used for the first tensile membrane. For example, the first tensile membrane can be a first textile. However, it is also conceivable to use non-textile materials, such as additively manufactured materials, e.g. additively manufactured sheets. These additively manufactured sheets may e.g. be porous and / or grid-like. In further embodiments, the first tensile membrane is a mesh, e.g. a metal mesh and / or a polymeric mesh and / or a ceramic mesh.P29243PC00 24.03.2026
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[0033] The use of a first textile as first tensile membrane was found to be particularly advantageous because textiles can be chosen such that they display high tensile strength, high biocompatibility, essentially no toxicity and high flexibility. Additionally, textiles can be cheap and can be particularly suitable for manufacturing the fixator. Depending on the textile used, textiles can also have low creep and low long-term fatigue.
[0034] It is understood that a textile is in general a flexible material made of a plurality of filaments that are interlaced, knitted, woven, felted or bonded together. Depending on the application, different textiles may be used. In some embodiments, the first textile is a woven, braided and / or knitted first textile. These embodiments are advantageous because they allow fine-tuning of the load bearing properties and can be chosen such that high tensile strength can be achieved, while also ensuring flexibility.
[0035] Particularly useful weaves include leno weave and mock leno weave. Thus, the first textile may e.g. comprise a leno weave and / or a mock leno weave. These weaves advantageously combine high tensile strength and porosity, thereby allowing cellular in-growth and other interaction of the first bioactive material with the surrounding tissue.
[0036] Choosing a braided first textile can be advantageous for applications in which high ultimate tensile strength is desirable. Depending on the application, different braids can be used. For example, unidirectional braids and / or biaxial braids can be chosen to provide low friction coefficients and a cheap first textile. Thus, in some embodiments, the first textile comprises a unidirectional braid and / or a biaxial braid. However, in some applications, it may be useful to use triaxial braids, e.g. in order to provide first textiles having pores while still ensuring high tensile strength. Thus, in some embodiments, the first textile comprises a triaxial braid.P29243PC00 24.03.2026
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[0038] Irrespective of whether the first tensile membrane is a textile or not, different materials may be used for the first tensile membrane. For example, the first tensile membrane may e.g. comprise or be made of a polymer, such as a high tensile strength polymer, e.g. polyethylene terephthalate (PET). Preferably, high tenacity PET (HT-PET) may be used. For example, a PET or HT-PET sheet may be used for the first tensile membrane, or the first tensile membrane may be a first textile made of a plurality of PET filaments, e.g. HT-PET filaments. One advantage of using polymers is that the polymeric material may be chosen such that high tensile strength, low toxicity and flexibility are advantageously combined. Furthermore, polymeric materials can also be easily processed and are available in porous or grid-like structures.
[0039] It is also possible to use non-polymeric materials. For example, in some embodiments, the first tensile membrane is made of a metal and / or ceramic.
[0040] The fixator comprises the first tensile membrane and the first bioactive material. It is understood that this terminology does not imply that the first tensile membrane is not bioactive. Rather, in some embodiments, the first tensile membrane is bioactive. For example, the first tensile membrane could be made of a bioactive material, such as a textile made from bioactive filaments. However, in at least some embodiments, the first tensile membrane is bioinert.
[0041] The first tensile membrane is configured for load transfer between the first end and the second end of the load-bearing element. To this end, the first tensile membrane may for example extend from the first end of the load-bearing element to the second end of the load-bearing element. However, it is also possible for the first tensile membrane to be interconnected with further tensile structures or components which collectively extend from the first end of the load-bearing element to the second end of the load-bearing element for load transfer.P29243PC00 24.03.2026
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[0043] The first bioactive material is in interaction with the outer side of the first tensile membrane for interaction with the surrounding tissue in a patient’s body. It is understood that the outer side of the first tensile membrane is a side of the first tensile membrane which in the mounter position faces outwardly. For example, the outer side of the first tensile membrane may face the surrounding tissue in the mounted position.
[0044] Depending on the application, the interaction between the first bioactive material and the outer side may be established in different ways. In some embodiments, the first bioactive material covers an outer surface of the fixator at least partially. For example, the first bioactive material may e.g. be arranged on the outer surface of the fixator. For example, the first bioactive material may contact the outer surface of the fixator, or the first bioactive material may be interconnected with the outer surface of the fixator through one or more intermediate structures, e.g. intermediate layers such as an adhesive layer or a connective layer connecting the first bioactive material and the outer surface of the fixator.
[0045] Alternatively or in combination, the first bioactive material may also be connected to the outer surface of the fixator through a plurality of pores. For example, the plurality of pores may e.g. be pores passing at least through the first tensile membrane. In some embodiments, the first tensile membrane comprises a plurality of pores interconnecting the first bioactive material with the at least one outer side of the first tensile membrane. The plurality of pores may e.g. pass from the at least one outer side to an oppositely arranged second side of the first tensile membrane. Depending on the application, the second side may be a second outer side or an inner side of the first tensile membrane.
[0046] The fixator comprises at least a first bioactive material. The first bioactive material (and any optional further bioactive materials) is configured for interaction with the surrounding tissue in a patient’s body. For example, the first bioactive material (and any optionalP29243PC00 24.03.2026
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[0048] further bioactive materials) may e.g. be configured for promoting cellular in-growth of the surrounding tissue in a patient’s body. As an example, the first bioactive material (and any optional further bioactive material) may e.g. provide a scaffold for the cellular ingrowth. Alternatively or in combination, the first bioactive material (and any optional further bioactive materials) may be able to stimulate cellular in-growth, e.g. by providing nutrients and / or growth factors and / or cytokines and / or extracellular matrix (ECM) proteins and / or providing therapeutic agents. As an example, in some embodiments, the first bioactive material (and any optional further bioactive materials) comprises ECM proteins for promoting cellular in-growth of the surrounding tissue into the fixator. Advantageously, the first bioactive material forms a scaffold for cellular in-growth in the mounted position. Alternatively or in combination, the first bioactive material may e.g. be an absorbable bioactive material. Such an absorbable bioactive material may e.g. allow the first bioactive material to be remodeled into functional tissue over time after implantation.
[0049] Depending on the application, the first bioactive material (and any optional further bioactive materials) may be made of different materials. For example, the first bioactive material may e.g. be a first bioactive polymer. Similarly, any optional further bioactive material may e.g. be a bioactive polymer. One advantage of using bioactive polymers is that they tend to display high biocompatibility and can be suitable for promoting cellular in-growth of the surrounding tissue into the fixator.
[0050] Advantageously, the first bioactive material (and any optional further bioactive materials) is made of a fibrous material. For example, in some embodiments, the first bioactive material (and any optional further bioactive materials) comprises or is made of a collagen-based material, preferably collagen. In some embodiments, the first bioactive material comprises a collagen matrix.P29243PC00 24.03.2026
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[0052] It is particularly advantageous to use collagen-based materials for the first bioactive material (and any optional further bioactive materials). The collagen-based material may for example be or comprise collagen. For example, the first bioactive material (and any optional further bioactive materials) may be a collagen-based material having a three-dimensional structure that is at least partially porous and / or fibrous. The collagen-based material may for example be configured to support or facilitate cellular in-growth, adhesion, proliferation, and / or tissue integration. The collagen-based material may e.g. comprise native, denatured, crosslinked, or otherwise modified collagen. Depending on the application, the collagen-based material can be in the form of a sponge, scaffold, membrane, gel, film, or other suitable configuration.
[0053] Using collagen-based materials is particularly advantageous because these materials are highly biocompatible. Furthermore, they display advantageous physical properties, including e.g. deformability, which can be used e.g. to obtain a deformable cross-section of the fixator, which can be used for improving load transfer. A further advantage is that depending on the collagen-based material used, the collagen-based material can be swellable, which can be used to enhance the deformability. Furthermore, collagen-based materials can be used to provide the fixator which a low friction coefficient, which can be advantageous to minimize friction with adjacent tissue. In some embodiments, the first bioactive material (and any optional further bioactive materials) is made of collagen, e.g. a collagen matrix or a collagen scaffold. For example, a collagen sponge may be used.
[0054] In some embodiments, the first bioactive material (and any optional further bioactive materials) may be a hydrogel.
[0055] Irrespective of the material used for the first bioactive material, it is advantageous to use a first bioactive material which is swellable upon absorption of water. For example, swelling may be used to obtain a fixator which has a deformable cross-section. It is particularlyP29243PC00 24.03.2026
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[0057] advantageous if the first bioactive material is swellable in radial direction against a sheath, for increasing a cross-section area of the sheath. The sheath will be described in further detail below.
[0058] Depending on the application, the fixator may comprise a second bioactive material. For example, the first bioactive material and the second bioactive material may be arranged on opposite sides of the first tensile membrane. In some embodiments, the second bioactive material may e.g. cover at least a portion of the at least one outer side of the first tensile membrane. Alternatively or in combination, the first bioactive material may e.g. face an oppositely arranged second side of the first tensile membrane. Advantageously, the first bioactive material and the second bioactive material are interconnected to each other through the plurality of pores passing through the first tensile membrane. For example, the first bioactive material and the second bioactive material can be the same material.
[0059] In some embodiments, the second bioactive material is arranged on an outer surface of the fixator. For example, the second bioactive material may be configured to contact the surrounding tissue. The second bioactive material may e.g. be used to provide the fixator with a low-friction surface. This is advantageous in order to reduce harm to surrounding tissue, which may otherwise be caused by friction, and, vice versa, to reduce harm to the textile due to abrasion. More broadly, arranging the second bioactive material on the outer surface of the fixator allows tissue to grow on the surface of the fixator, which minimizes friction or abrasion.
[0060] Depending on the application, it can be advantageous for the fixator to comprise at least one compartment containing the first bioactive material. For example, the at least one compartment could be a pouch containing the first bioactive material. The pouch may optionally be closed or at least partially open. For example, the at least one compartmentP29243PC00 24.03.2026
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[0062] could be a pocket. Preferably, the pouch is closed or closable. In some embodiments, the at least one compartment is formed by the first tensile membrane. However, it is also possible for the at least one compartment to be formed by another component or material, such as an additional layer sutured to the first tensile membrane.
[0063] Alternatively or in combination, the fixator may comprise a further compartment (e.g. a pouch or pocket) containing the lock described in further detail below (i.e. the lock interconnected in the mounted position to the first tail and / or the second tail to maintain the load-bearing element in a pre-tension in the mounted position). These embodiments can be advantageous, e.g. to securely position the lock to avoid displacement of the lock and / or to shield or otherwise protect the lock (which could e.g. be made of metal) from the environment and vice versa. For example, when the lock is arranged inside the further compartment, contact between the lock and the bone or other biological structures may be avoided. Furthermore, inadvertent loosening of the first tail and / or the second tail with respect to the lock can be avoided by containing the lock inside the further compartment. Depending on the application, the further compartment containing the lock and the at least one compartment containing the first bioactive material can be the same compartment or can be different compartments.
[0064] The at least one compartment can e.g. be advantageous to control the location and arrangement of the first bioactive material and / or to protect the first bioactive material. The at least one compartment may also be used to control a three-dimensional shape of the first bioactive material in the mounted position. As an example, where the first bioactive material is swellable, it can be particularly advantageous for the fixator to comprise the at least one compartment. In these embodiments, the at least one compartment can be shaped and arranged such that it controls the swelling behavior of the first bioactive material. For example, the at least one compartment could in some embodiments haveP29243PC00 24.03.2026
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[0066] a lower elasticity in longitudinal direction of the load-bearing element than in lateral direction of the load-bearing element. In these embodiments, when the first bioactive material swells in the mounted position, the lower elasticity in longitudinal direction could result primarily in swelling in the lateral direction, which would increase the surface area available for load distribution, thereby ultimately improving load distribution and load transfer. Alternatively or in combination, the at least one compartment could in some embodiments have a length in longitudinal direction exceeding a width in lateral direction.
[0067] Depending on the application, the fixator may have different shapes and geometries. In some embodiments, the fixator has a tubular cross-section. These embodiments are particularly advantageous for many applications, including e.g. when using the fixator for tissue repair or tissue regeneration, such as ligament or tendon reconstruction. In some embodiments, the fixator is essentially flat, e.g. essentially planar. These embodiments can be advantageous for other tissue regeneration applications, e.g. using the fixator as a patch.
[0068] Regardless of the specific shape, it is particularly advantageous if the tubular fixator has a width of at least 2 mm, preferably at least 5 mm. These embodiments minimize the risk of the fixator cutting into tissue or bones or other biological structures with which the fixator comes into contact in the mounted position.
[0069] It is particularly advantageous for many applications to use a fixator having a core-sheath arrangement. For example, in some embodiments, the first bioactive material forms a core circumferentially encompassed by a sheath formed by the first tensile membrane. These embodiments are advantageous because they tend to display high stability and, in particular, high tensile strength, while also having a favorable arrangement for cellularP29243PC00 24.03.2026
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[0071] in-growth of surrounding tissue. Furthermore, because the first bioactive material is circumferentially encompassed by the sheath, it is securely held in place and can e.g. impart deformability in a controlled fashion.
[0072] Depending on the application, the fixator may comprise one or more sheaths. For example, in some embodiments, the fixator comprises a first sheath formed by the first tensile membrane and a second sheath formed by the second tensile membrane and circumferentially encompassing at least partially the first sheath.
[0073] Irrespective of the number of sheaths, in some embodiments, the core pushes the first tensile membrane radially outwardly in the mounted position, thereby biasing the first tensile membrane towards a maximum cross-sectional area. For example, first bioactive material may be swellable and the swelling may cause the core to push the first tensile membrane radially outwardly in the mounted position upon swelling. These embodiments are advantageous for providing a deformable cross-section.
[0074] In some embodiments, the load-bearing element further comprises a second bioactive material covering at least a portion of an outer surface of the sheath formed by the first tensile membrane. Thus, the second bioactive material may e.g. be used to provide the fixator with a low-friction outer surface. Preferably, the second bioactive material is interconnected with the first bioactive material through the plurality of pores passing through the first tensile membrane.
[0075] Advantageously, the second bioactive material may form a coating on the outer surface of the first tensile membrane. Alternatively or in combination, the second bioactive material may form a further sheath circumferentially encompassing the sheath formed by the first tensile membrane.P29243PC00 24.03.2026
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[0077] In some embodiments, the load-bearing element comprises a plurality of at least two layers stacked on top of each other and each extending in the longitudinal direction and in the transversal direction, wherein a first layer is formed by the first bioactive material and a second layer is formed by the first tensile membrane.
[0078] Advantageously, the second layer is sandwiched between the first layer and a third layer formed by a second bioactive material. For example, in these embodiments, the second layer may comprise a first outer side and a second outer side, wherein the first outer side may be covered by the first layer and the second outer side may be covered by the third layer.
[0079] Depending on the application, the plurality of layers may be connected to each other in different ways. In some embodiments, the plurality of layers are connected to each other by an adhesive and / or by a stitch.
[0080] In some applications, the sandwiched structure is used as such, e.g. in the form of a patch. However, for at least some applications, it may be useful to wind up the layers to obtain a more longitudinal or tubular structure. For example, these applications may include tendon or ligament reconstruction. Thus, in some embodiments, the plurality of layers are wound up to form a Swiss roll.
[0081] The fixator comprises at least the first tensile membrane and the first bioactive material. Depending on the application, it can be advantageous for the load-bearing element to comprise a first tail and / or a second tail, e.g. for interconnecting the first tail and the second tail together for forming a loop in the mounted position. More generally, the first tail and / or the second tail may e.g. be used for fixation of the fixator in the body of the patient and / or for tensioning the fixator.P29243PC00 24.03.2026
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[0083] In some embodiments, the load-bearing element merges at the first end into a first tail and / or at the second end into a second tail. Preferably, the first tail and / or the second tail are each interconnected to the first tensile membrane. For example, the first tensile membrane and the first tail may be integrally formed. Alternatively or in combination, the first tensile membrane and the second tail may be integrally formed.
[0084] Depending on the application, the first tail respectively the second tail may or may not vary from adjacent sections of the load-bearing element. For example, the first tail (and / or the second tail) may or may not have a smaller cross section than an adjacent section of the load-bearing element. Furthermore, the first tail (and / or the second tail) may or may not have a different structure than an adjacent section of the load-bearing element.
[0085] In some embodiments, the first tail and the second tail are configured to be connected to each other in a mounted position, e.g. for forming a loop. In some embodiments, the fixator may comprise at least one lock interconnected in the mounted position to the first tail and / or the second tail to maintain the load-bearing element in a pre-tension in the mounted position. For example, the lock may comprise a button, such as a self-locking button. For example, the button may be interconnected with the first tail and / or with the second tail such that a free end of the first tail and / or a free end of the second tail may be pulled to apply a tension to the load-bearing element, but where the first tail and / or the second tail blocks itself when the pull-force is removed, thereby preventing loss of the applied tension. In some variations, the button is an Arthrex TightRope button or an Arthrex TightRope II button.
[0086] In some embodiments, the lock is in an unlocked state displaceable along a length of the first tail and / or along a length of the second tail. Optionally, in a locked state displacementP29243PC00 24.03.2026
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[0088] of the lock along the length of the first tail and / or along the length of the second tail is blocked in at least one direction.
[0089] The fixator disclosed herein advantageously combines mechanical and biological properties. In particular, the fixator is able to provide stability in the short-, medium- and longterm, as well as biocompatibility, e.g. by its ability to provide a scaffold for cellular ingrowth and cellular proliferation. These abilities make the fixator useful for a broad range of different applications. For example, the fixator may be used for ligament reconstruction or replacement or reinforcement; or tendon reconstruction or replacement or reinforcement. More broadly, the fixator may generally be used for restraining a first bone with respect to a second bone (e.g. bone-to-bone connections), or for restraining a first bone with respect to a soft tissue (e.g. bone-to-soft-tissue connections).
[0090] Possible applications for restraining a first bone with respect to a second bone include e.g. applications in the spine, the shoulder (e.g. for acromioclavicular (AC) joint separation repair), the knee (e.g. for anterior cruciate ligament repair or posterior cruciate ligament repair or anterolateral ligament repair), the elbow (e.g. for lateral ulnar collateral ligament repair), the hand or wrist (e.g. Ligamentum interosseum scapholunatum repair or triangular fibrocartilage complex repair or medial collateral ligament repair or posterolateral corner repair or lateral collateral ligament repair), or the foot or ankle (lateral ankle ligament repair or Lisfranc ligament repair or spring ligament repair) of a patient. For example, in the case of spinal applications, the fixator may be used e.g. for spinal stabilization (e.g. in the context of posterior spinal stabilization with a tension band, for example for applications such as vertebropexy).
[0091] Possible applications for restraining a first bone with respect to a soft tissue (e.g. bone-to-soft-tissue connections) include e.g. applications in the shoulder (e.g. rotator cuff repair), elbow (e.g. distal biceps reconstruction), the hand or wrist, the knee (e.g. patellarP29243PC00 24.03.2026
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[0093] tendon repair or quadriceps tendon repair), foot or ankle (e.g. achilles tendon repair or tibialis posterior repair) of a patient.
[0094] Depending on the application, the fixator experiences different loads and load profiles in the mounted position. For example, in applications where the fixator adopts a primarily linear orientation in the mounted position and is pre-tensioned between two body structures connected to the first and second end of the fixator, the fixator is primarily exposed to linear tension loads between its first and second end. In these embodiments, it can be advantageous to provide a fixator having an appropriate tension load profile. For example, a limited degree of flexibility may be desirable in an initial tension window, e.g. for initial pre-tensioning, but a high tensile strength may be desirable at increasing tensile loads after the initial tension window.
[0095] In some applications, the fixator may contact a body structure in the mounted position, e.g. for load transfer to that body structure. As an illustrative example, the fixator may e.g. in some applications form a semi-loop in the mounted position which encompasses a body structure which is to be tensioned with respect to another body structure. In these embodiments, for example, it is advantageous if the load-bearing element comprises one or more load-bearing surfaces arranged in the longitudinal direction between the first end and the second end. For example, a first load-bearing surface may be configured for contacting in a mounted position the first bone.
[0096] Advantageously, the first bioactive polymer may be arranged at least in the region of the one or more load-bearing surfaces.
[0097] Advantageously, the load-bearing element in the region of the first load-bearing surfaces has a deformable cross-section which in the mounted position flattens in lateral direction when in contact with a first bone in the region of the first load-bearing surface, such thatP29243PC00 24.03.2026
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[0099] the load is distributed in lateral direction. These embodiments are advantageous because the deformable cross-section contributes to improved load distribution, e.g. by increasing a surface area across which the load is distributed. Furthermore, the deformable cross-section may also be used to enhance initiation of load transfer.
[0100] Depending on the application, the deformable cross-section may be realized in different ways. For example, the first tensile membrane may be chosen such that it has a deformable cross-section, e.g. by using certain weaves or braids and / or by chosen certain materials of which the first tensile membrane is made. Alternatively or in combination, the deformable cross-section may also be realized by appropriate placement of the first bioactive material. For example, in some embodiments, the first bioactive material is arranged at least in the region of the one or more load-bearing surfaces. It is noted that the first bioactive material may in these embodiments optionally contribute to a deformable cross-section.
[0101] Advantageously, the cross-section of the load-bearing element may in the region of the one or more load-bearing surfaces be wider in lateral direction than the cross-section of the load-bearing element in a region outside the one or more load-bearing surfaces in the mounted position. This is advantageous for effective load distribution and load transfer to the structure which the one or more load-bearing surfaces contact. In particular, initiation of load transfer is improved as well.
[0102] To optimize load transfer, it can also be advantageous for the load-bearing element to have a lower elasticity in longitudinal direction than in lateral direction. The relative elasticities can e.g. be used to enhance a surface area-widening of the load-bearing element upon contact with a body structure, which may contribute to load distribution across a larger surface, thereby reducing the risk of damage.P29243PC00 24.03.2026
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[0104] Depending on the application, it may be advantageous for the load-bearing element to have in the region of the one or more load-bearing surfaces a width of at least 2 mm, preferably at least 5 mm. These widths may e.g. minimize damage to surrounding body structures. In particular, where the load-bearing element contacts with the one or more load-bearing surfaces a certain body structure (e.g. the first bone), providing a minimum width of at least 2 mm minimizes the risk of the fixator cutting into the body structure.
[0105] Depending on the application, the fixator may in the mounted position have different arrangements. For some applications, it may be beneficial to configure the fixator such that it forms a closed loop in the mounted position. One possible application of this is for encircling two adjacent vertebrae, e.g. for encircling the spinous processes of two adjacent vertebrae. Possibly applications include spinal stabilizations, e.g. in the context of a recent technique called vertebropexy. Other possible applications where a closed loop in the mounted position may be advantageous are cerclage applications.
[0106] A closed loop may be realized in different ways. In some cases, the fixator comprises a second load-bearing surface configured for contacting in the mounted position the second bone, wherein the fixator forms in the mounted position a closed loop encircling the first bone and the second bone.
[0107] BRIEF DESCRIPTION OF THE DRAWINGS
[0108] The disclosure described herein will be more fully understood from the detailed description given herein below and the accompanying drawings, which should not be considered limiting to the disclosure described in the appended claims. The drawings show:
[0109] Fig. 1 shows an embodiment of the fixator described herein;P29243PC00 24.03.2026
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[0111] Fig. 2 shows a cross-section of a first variant of the fixator illustrated in Fig. 1 ;
[0112] Fig. 3 shows a cross-section of a second variant of the fixator illustrated in Fig. 1 ;
[0113] Fig. 4 shows a cross-section of a third variant of the fixator illustrated in Fig. 1 ;
[0114] Fig. 5 shows a cross-section of a fourth variant of the fixator illustrated in Fig. 1 ;
[0115] Fig. 6 shows a further embodiment of a fixator having two load-bearing surfaces in a full, side view (Fig. 6A), as well as in a cross-sectional view in a region outside the load-bearing surfaces (Fig. 6B) and in a region of the load-bearing surfaces (Fig. 6C) ;
[0116] Fig. 7 shows a further embodiment of a fixator formed by two layers stacked on top of each other;
[0117] Fig. 8 shows a further embodiment of a fixator formed by three layers stacked on top of each other;
[0118] Fig. 9 shows a further embodiment of a fixator formed by a coated textile layer;
[0119] Fig. 10 shows a further embodiment of a fixator having a Swiss roll shape, shown in a cross-sectional view.
[0120] DESCRIPTION OF THE VARIATIONS
[0121] Reference will now be made in detail to certain variations, examples of which are illustrated in the accompanying drawings, in which some, but not all features are shown. Indeed, variations disclosed herein may be embodied in many different forms and shouldP29243PC00 24.03.2026
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[0123] not be construed as limited to the variations set forth herein; rather, these variations are provided so that this disclosure will satisfy applicable legal requirements. Whenever possible, like reference numbers will be used to refer to like components or parts. Should a reference sign be missing in one drawing reference is made to the other drawings.
[0124] Figure 1 shows an embodiment of the fixator 1 described herein. The illustrated fixator 1 comprises a strap-like load-bearing element 2 extending in longitudinal direction from a first end 21 to a second end 22. At the first end 21 , the load-bearing element merges into a first tail 25 and at the second end 22, it merges into a second tail 26. The first tail 25 and the second tail 26 can be used during implantation for interconnecting the fixator 1 to one or more body structures. For example, for tendon or ligament replacement applications, the first end 25 may be interconnected to a first bone (not illustrated) and the second end 26 may be interconnected to a second bone or a soft tissue (not illustrated), and the load-bearing element may subsequently be tensioned. However, it is also possible connect the first end 25 and second end 26 together to form a loop. The loop can e.g. be used to encircle a biological structure, for example the spinous processes of two or more vertebrae for spinal stabilization, or in cerclage applications.
[0125] The load-bearing element 2 is formed by at least one tensile membrane and at least one bioactive material in interaction with the tensile membrane. Optionally, it may comprise more tensile membranes and / or more bioactive materials. Different exemplary arrangements are illustrated in figures 2-5 and will be discussed in further detail. However, it is understood that other cross-sectional profiles or shapes can also be used.
[0126] Figures 2-5 illustrate cross-sectional profiles of different variants of the fixator 1 described herein, e.g. of the fixator illustrated in Fig. 1. More specifically, the cross-sectional profiles of the respective load-bearing element 2 is shown in each case.P29243PC00 24.03.2026
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[0128] In the embodiment illustrated in Figure 2, the load-bearing element 2 is formed by a first tensile membrane 3 which forms a sheath circumferentially enclosing a core formed by a first bioactive material 4. For example, the first tensile membrane 3 may be formed by a polymeric material, such as HT-PET. The first tensile membrane 3 may e.g. be a braided, woven or knitted structure, preferably leno weave or mock leno weave. The first bioactive material 4 can be formed of many different materials. For example, electrospun structures or sponges can be used. Collagen-based materials such as collagen sponges are particularly advantageous for certain applications because they provide a biocompatible scaffold for cellular in-growth and cellular proliferation. Optionally, the first bioactive material may comprise extracellular matrix proteins to aid cellular in-growth of surrounding tissue in the mounted position.
[0129] To enable cellular in-growth and, more generally, interaction with the surrounding tissue, the first tensile membrane 3 comprises in the illustrated embodiment a plurality of pores (not illustrated) through which e.g. surrounding tissue can interact with the first bioactive material 4 forming the core. Eventually, over time, the surrounding tissue may proliferate into the fixator and a functional tendon or ligament may be formed inside and around the first tensile membrane 3. This will not only protect the textile from abrasion, but will also contribute to the load-bearing function of the fixator in the long term, while in the short term, the load-bearing function is initially primarily fulfilled by the first tensile membrane 3.
[0130] In the embodiment illustrated in Fig. 2, furthermore, an outer surface of the first bioactive material 4 contacts an inner surface of the first tensile membrane 3. Thereby, the volume of the first bioactive material 4 keeps the sheath round, at least in an untensioned state. When the load-bearing element 2 contacts a bone or another structure for load transfer, deformation of the first bioactive material forming the core may occur, which would leadP29243PC00 24.03.2026
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[0132] to a flattening of the load-bearing element in lateral direction, thereby aiding load transfer and initiation of load transfer.
[0133] Figure 3 illustrates a further embodiment of the load-bearing element 2 in which the loadbearing element 2 is also formed by a first tensile membrane 3 and a first bioactive material 4, but unlike the embodiment of Fig. 2, the first bioactive material 4 forms a sheath which at least partially circumferentially encloses a core formed by the first tensile membrane 3. The materials of the first bioactive material 4 and of the first tensile membrane 3 may e.g. be chosen as described in the context of Fig. 2 above.
[0134] The variant shown in Fig. 3 may e.g. be used to provide a bioactive outer surface of the load-bearing element 2. For example, when the first bioactive material 4 is collagen-based, the outer surface has low friction properties which could be advantageous to prevent abrasion. Furthermore, a more direct contact of adjacent tissue with the first bioactive material 4 is provided because the bioactive material 4 is arranged on an outer surface of the first tensile membrane 3.
[0135] As illustrated in Fig. 3, the first tensile membrane 3 advantageously extends beyond an end of the first bioactive material in longitudinal direction in order to allow the first tensile membrane 3 to be connected to a body structure for load transfer, or to merge into a first or second end, which may ultimately e.g. be connected to a body structure for load transfer.
[0136] Figure 4 illustrates a further embodiment of the load-bearing element 2 which may be seen as a combination of the embodiments shown in Figs. 2 and 3 in that the embodiment of Fig. 4 comprises a first tensile membrane 3, a first bioactive material 4 and a second bioactive material 6. The first bioactive material 4 forms a core circumferentially enclosing a sheath formed by the first tensile membrane 3. The first tensile membraneP29243PC00 24.03.2026
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[0138] 3, in turn, itself also forms a core which is at least partially circumferentially enclosed by the second bioactive material 6. Once again, the materials of the first tensile membrane, of the first bioactive material and of the second bioactive material may be chosen as indicated above in the context of Fig. 2.
[0139] One advantage of the embodiment of Fig. 4 is that the first bioactive material 4 may be used to provide a cushioning effect and for keeping the first tensile membrane round, ultimately leading to enhanced load distribution and improved initiation of load transfer with adjacent body structures. Furthermore, the first bioactive material 4 may be used as a scaffold for in-growth of adjacent tissue. At the same time, the second bioactive material 6 is in direct contact with adjacent tissue and therefore accelerates the process of ingrowth of adjacent tissue. Furthermore, because the second bioactive material 6 is arranged on an outer surface of the load-bearing element 2, it may also be used to reduce friction on an outer surface, thereby minimizing damage due to e.g. abrasion.
[0140] It is particularly advantageous for the first bioactive material 4 and the second bioactive material 6 to be interconnected to each other, preferably through pores passing through the first tensile membrane 3 (not illustrated in Fig. 4).
[0141] Figure 5 illustrates a further embodiment of the load-bearing element 2. As seen in the cross-sectional view shown in Fig. 5, the load-bearing element 2 has a flatter shape compared to the rounder cross-sectional shapes of the embodiments of Figs. 2-4. Apart from the flatter shape, the load-bearing element 2 of Fig. 5 is similar to that of Fig. 4 in that it also comprises a first bioactive material 4 forming a core and a first tensile membrane 3 forming a first sheath enclosing the first core. Furthermore, the load-bearing element 2 also comprises a second bioactive material 6 which forms a coating on an outer surface of the first tensile membrane 3.P29243PC00 24.03.2026
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[0143] One advantage of the flatter shape of the embodiment of Fig. 5 is that a larger contact area can be realized when the load-bearing element 2 contacts a body structure for load transfer, which ultimately leads to a wider load distribution.
[0144] Figures 6A-6C illustrate a further embodiment of the fixator 1 . The fixator 1 is largely similar to the embodiment shown in Figs. 1 and 5. One difference between the embodiments is that the fixator 1 shown in Figs. 6A-6C has a varying cross-section along its length in longitudinal direction. More specifically, the fixator 1 has a load-bearing element 2 which comprises two load-bearing surfaces 23 and 24. In the region of the load-bearing surfaces 23, 24, the load-bearing element 2 comprises a first tensile membrane 3 (e.g. formed by leno or mock leno weave), a first bioactive material 4 (e.g. collagen-based material) forming a core encompassed by the first tensile membrane 3, and a second bioactive material 6 forming a coating on the first tensile membrane 3. Thus, in the region of the load-bearing surfaces 23, 24, the load-bearing element 2 has a similar structure to the embodiment illustrated in Fig. 5.
[0145] However, in the regions of the load-bearing element 2 outside the load-bearing surfaces 23, 24, the load-bearing element 2 is formed by the first tensile membrane 3 and the second bioactive material 6 (forming the coating), but is devoid of the first bioactive material 4. This is realized through compartments 5, e.g. pouches, of the first tensile membrane 3 which are arranged in the regions of the load-bearing surfaces 23, 24 and which contain the first bioactive material 4. The pouches 5 and the arrangement in the region of the first and second load-bearing surfaces 23, 24 allows the fixator 1 to benefit from improved load-bearing and load distribution properties, as described hereinbefore.
[0146] Figures 7-8 describe a further embodiment of the fixator 1 described herein, having a more planar structure. More specifically, the fixators 1 are formed by at least two layers. In the embodiment shown in Fig. 7, the fixator 1 is formed by a first layer formed by theP29243PC00 24.03.2026
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[0148] first bioactive material 4 and a second layer formed by the first tensile membrane 3, which is stacked on and attached to the first layer. In the embodiment shown in Fig. 7, the fixator 1 additionally comprises a third layer which is formed by a second bioactive material 6. The first and second bioactive materials 4, 6 are arranged on opposite sides of the first tensile membrane 3.
[0149] For illustration purposes, the different layers are shown in Figs. 7 and 8 in an interspaced fashion. However, it is understood that the layers are in fact stacked on top of each other and connected to each other, e.g. through an adhesive.
[0150] Figures 9 and 10 show further embodiments of the fixator 1 described herein. More specifically, Fig. 9 illustrates an embodiment of a patch-like fixator 1 which comprises a load-bearing element 2 formed by a first tensile membrane 3 coated with a first bioactive material 4. The bioactive material 4 can e.g. be a collagen coating on a textile layer forming the first tensile membrane 3.
[0151] As illustrated by the curled arrow in Fig. 9, the fixator 1 illustrated in Fig. 9 can optionally be wound up to form a Swiss roll, thereby providing the fixator 1 illustrated in Fig. 10 in a cross-sectional view. Optionally, an adhesive can be applied to a surface of the fixator 1 before winding up the fixator 1 in order to stabilize the fixator in the Swiss roll configuration of Fig. 2.
[0152] Winding up to form a Swiss roll leads to a less planar and a more tubular implant. An advantage of the tubular Swiss roll arrangement is that surrounding tissue growing into the fixator 1 regularly encounters the bioactive material 4 at different infiltration or ingrowth depths. This can be used to enhance cellular in-growth over time and can, in particular, promote formation of deep penetration depths of cellular in-growth.P29243PC00 24.03.2026
[0153] 28 / 32 LIST OF DESIGNATIONS
[0154] 1 Fixator
[0155] 2 Strap-like load-bearing element
[0156] 21 First end
[0157] 22 Second end
[0158] 23 First load-bearing surface
[0159] 24 Second load-bearing surface
[0160] 25 First tail
[0161] 26 Second tail
[0162] 3 First tensile membrane
[0163] 4 First bioactive material
[0164] 5 Compartment
[0165] 6 Second bioactive material
Claims
P29243PC00 24.03.202629 / 32PATENT CLAIMS1 . Fixator (1 ) for restraining a first bone with respect to a second bone or a soft tissue, the fixator (1) comprising:a. A strap-like load-bearing element (2) extending in a longitudinal direction from a first end (21) to a second end (22), the load-bearing element (2) comprising a first tensile membrane (3) for load transfer between the first end (21) and the second end (22), wherein the first tensile membrane (3) extends in the longitudinal direction and in a transversal direction orthogonal to the longitudinal direction and comprises at least one outer side; andb. Wherein said at least one outer side is in interaction with a first bioactive material (4) for interaction with a surrounding tissue in a patient’s body.
2. Fixator (1) according to claim 1 , wherein the first tensile membrane (3) is porous and / or grid-shaped.
3. Fixator (1) according to any one of the previous claims, wherein the first tensile membrane (3) is a first textile, preferably a woven, braided and / or knitted first textile, more preferably a leno weave, a mock leno weave, a biaxial braid or a triaxial braid.
4. Fixator (1 ) according to any one of the previous claims, wherein the first bioactive material (4) is a first bioactive polymer.P29243PC00 24.03.202630 / 325. Fixator (1 ) according to any one of the previous claims, wherein the first bioactive material (4) covers an outer surface of the fixator (1) at least partially and / or is connected to the outer surface of the fixator (1 ) through a plurality of pores passing through the first tensile membrane (3).
6. Fixator (1) according to any one of the previous claims, wherein the fixator (1) comprises at least one compartment (5) containing the first bioactive material (4).
7. Fixator (1 ) according to any one of the previous claims, wherein the fixator (1 ) has a tubular cross-section.
8. Fixator (1 ) according to any one of the previous claims, wherein the first bioactive material (4) forms a core circumferentially encompassed by a sheath formed by the first tensile membrane (3).
9. Fixator (1 ) according to claim 8, wherein the load-bearing element (2) further comprises a second bioactive material (6) covering at least a portion of an outer surface of the sheath formed by the first tensile membrane (3).
10. Fixator (1) according to claim 9, wherein the second bioactive material (6) forms a coating on the outer surface of the first tensile membrane (3) and / or wherein the second bioactive material (6) forms a further sheath circumferentially encompassing the sheath formed by the first tensile membrane (3).11 . Fixator (1 ) according to claim 9 or 10, wherein the second bioactive material (6) is interconnected with the first bioactive material (4) through the plurality of pores passing through the first tensile membrane (3).P29243PC00 24.03.202631 / 3212. Fixator (1 ) according to any one of the previous claims, wherein the load-bearing element (2) comprises a plurality of at least two layers stacked on top of each other and each extending in the longitudinal direction and in the transversal direction, wherein a first layer is formed by the first bioactive material (4) and a second layer is formed by the first tensile membrane (3).
13. Fixator (1 ) according to claim 12, wherein the second layer is sandwiched between the first layer and a third layer formed by a second bioactive material (6).
14. Fixator (1) according to any one of claims 12-13, wherein the plurality of layers are wound up to form a Swiss roll.
15. Fixator (1 ) according to any one of the previous claims, wherein the first bioactive material (4) forms a scaffold for cellular in-growth in the mounted position.
16. Fixator (1 ) according to any one of the previous claims, wherein the first bioactive material (4) comprises a collagen-based material.
17. Fixator (1 ) according to any one of the previous claims, wherein the load-bearing element (2) comprises one or more load-bearing surfaces (23, 24) arranged in the longitudinal direction between the first end and the second end (22), wherein a first load-bearing surface (23) is configured for contacting in a mounted position the first bone.
18. Fixator (1) according to claim 17, wherein the load-bearing element (2) in the region of the first load-bearing surfaces (23, 24) has a deformable cross-section which in the mounted position flattens in lateral direction when in contact with a first bone in the region of the first load-bearing surface (23, 24), such that the load is distributed in lateral direction.