Bone reduction device

Abstract

A bone fracture fixation device (10) for resetting a fractured bone, the device comprising at least two sleeve portions wherein a first sleeve portion (12) has a measure for surrounding the bone by more than 180 degrees and one or more further sleeve portions (14) supplement the first sleeve portion, thereby completely or substantially completely surrounding the fractured bone.

Description

Technical Field

[0001] The presently disclosed subject matter is in the field of bone health, and in particular, the field of bone fracture repair. Background Art

[0002] Bone breaks are typically reduced using an external cast or splint; or surgically by fastening rods, pins, or plates to the bone.

[0003] European Patent No. 0295041 discloses an internal fixation device for bone fractures, the internal fixation device having a frame structure consisting of three channel steels and two tension rings, each of the tension rings having at least one flexion structure and a fastening structure, so that the tension ring can be divided into two pieces and form a closed ring around the fractured bone. The edges of the channel steel and the tension ring have teeth formed on the edges, and the teeth are used to engage with the bone to achieve stable fixation. The directional arrangement of the teeth makes it possible to apply sufficient pressure to the fractured part through the patient's own weight and muscle structure. The device is suitable for fixing various types of bone fractures, and is conducive to uniform healing of bone fractures and increased strength of healed bones.

[0004] Chinese Patent Application No. 103976784 discloses a customized orthopedic internal fixation support. The support comprises an A-side support and a B-side support engaged with the bone surface, wherein a positioning hole A is formed in one end of the A-side support, a permanent hole is formed in the other end of the A-side support, and a reset screw A is arranged on the top of the A-side support; a stop pin is arranged at one end of the B-side support, a locking screw is arranged at the other end of the B-side support, and a reset screw B is arranged on the top of the B-side support; for plane fractures, a unilateral support is used, and the structure of the unilateral support is the same as that of a flat or deformed A-side support or B-side support.

[0005] U.S. Patent Application No. 2004 / 0087955 discloses a device for reducing and stabilizing a damaged bone part (e.g., resulting from a fracture) particularly suitable for veterinary use. The device comprises as a main element a tubular band for application around a bone at a fracture point or discontinuity, the tubular band being made of a metallic material and provided with longitudinal apertures and equipped with a plurality of substantially protruding protrusions distributed along its inner surface for gripping the damaged bone part. The tubular band is extensible to be tightly wrapped around the damaged bone part using a flexible cerclage element transversely fixed around the tubular band and received in an outer transverse groove.

[0006] U.S. Patent Application No. 2012 / 0029102 discloses a system for bone fracture repair. A system includes a biocompatible putty that can be filled around a bone fracture to provide full load-bearing capacity within a few days. The disclosed putty produces an osteoconductive scaffold for bone regeneration and degrades over time into harmless resorbable byproducts. Further disclosed is a fixation device for contacting the endosteal wall of the intramedullary (IM) canal of a fractured bone. Summary of the invention

[0007] The presently disclosed subject matter relates to a device for reducing a fractured bone, the device being configured to be inserted adjacent to the fractured bone to surround the fractured bone and secure the fractured bone in place.

[0008] It is an object of the present invention to provide such a device which does not require screws to be drilled into the bone to secure the device.

[0009] A further object of the present invention is to provide a device that can be feasibly inserted around a fractured bone despite the limited space due to the muscle tissue and ligaments surrounding the fractured bone.

[0010] A further purpose is to allow bone metabolism while the device is in use.

[0011] Yet another object of the present invention is to stabilize the fractured bone with minimal contact between the device and the bone.

[0012] It is an additional object of the present invention to provide a device that will promote fracture healing by providing bone growth factors and other therapeutic agents.

[0013] Another object of the present invention is to provide a method for fixing a fractured bone by implementing the device of the present invention.

[0014] In a first aspect, the present invention provides a bone fracture fixation device for repositioning a fractured bone, the device comprising:

[0015] A sleeve having dimensions for completely or substantially completely surrounding a segment of the fractured bone containing the fracture, the sleeve comprising:

[0016] At least two sleeve parts, wherein a first sleeve part has a dimension for enclosing more than 180 degrees, and a second sleeve part and optionally one or more further sleeve parts complement the first sleeve part, thereby completely or substantially completely enclosing the fractured bone when the device is in use.

[0017] In one or more embodiments, the first sleeve portion surrounds the fractured bone greater than 210 degrees, greater than 230 degrees, greater than 250 degrees, or greater than 270 degrees when the device is in use.

[0018] In one or more embodiments, the first sleeve portion surrounds the fractured bone at least 270 degrees when the device is in use.

[0019] In one or more embodiments, the device comprises a first sleeve portion and a second sleeve portion, wherein the first sleeve portion and the second sleeve portion surround 360 degrees around the fractured bone when the device is in use.

[0020] In one or more embodiments, the sleeve further comprises a plurality of protrusions attached to or extending from the inner wall of the sleeve when the device is in use to press on the fractured bone and secure the bone in place.

[0021] In one or more embodiments, the protrusion has a sharp or blunt tip.

[0022] In one or more embodiments, the protrusions are dispersed along the entire inner wall of the sleeve.

[0023] In one or more embodiments, the protrusions are distributed over two or more portions of the sleeve.

[0024] In one or more embodiments, the sleeve comprises two apertures through which the fractured bone passes when the device is in use, and the projections are dispersed about each of the apertures.

[0025] In one or more embodiments, a central portion of the inner wall of the sleeve proximal to the fracture has no protrusion.

[0026] In one or more embodiments, the protrusion defines a space between the bone and the sleeve.

[0027] In one or more embodiments, the protrusion is made of a rigid or semi-rigid material, which is the same or different from the material of the sleeve.

[0028] In one or more embodiments, the sleeve portion includes a plurality of pores for allowing nutrients and / or cells to pass therethrough to help accelerate the healing of the fractured bone.

[0029] In one or more embodiments, the combined area of ​​the plurality of apertures accounts for 20% to 60% of the area of ​​the sleeve.

[0030] In one or more embodiments, the sleeve parts comprise an inter-sleeve part locking mechanism for allowing closing of the sleeve.

[0031] In one or more embodiments, the locking mechanism comprises one or more of: a screw, a strap, a wire, a zip tie, a fastener, a flange, a cerclage, or a combination thereof.

[0032] In one or more embodiments, the locking mechanism is configured to allow closing of the sleeve to a given diameter.

[0033] In one or more embodiments, the locking mechanism comprises cooperating adjacent edges of the sleeve portions, the cooperating adjacent edges being adapted to allow the sleeve portions to overlap, thereby allowing adjustment of the diameter of the sleeve.

[0034] In one or more embodiments, the mechanism comprises a diameter adjustment fixing fastener comprising an adjustable strap / wire / tie for setting the sleeve diameter; or a through-the-tube fastener configured to attach overlapping sleeve regions.

[0035] In one or more embodiments, one or more of the sleeve portion and / or the protrusions include bone growth factors, bone growth hormones, bone growth minerals (e.g., calcium), bone cells and / or stem cells that can be released into the bone and help accelerate healing.

[0036] In one or more embodiments, the device further includes a membrane disposed in the inner surface of the one or more sleeve portions, the membrane including bone growth factors, bone growth hormones, bone growth minerals (e.g., calcium), bone cells and / or stem cells that can be released into the bone and help accelerate healing.

[0037] In another aspect, the present invention provides a method of fixing a fractured bone in a human or non-human patient, the method comprising:

[0038] (a) providing access to the fractured bone for a bone fracture fixation device as defined in any one of the preceding claims;

[0039] (b) placing a first sleeve portion at least partially around the fractured bone;

[0040] (c) placing a second sleeve portion and optionally one or more further sleeve portions around the fractured bone to completely or substantially completely surround at least a portion of the fractured bone; and

[0041] (d) fastening the sleeve parts to each other.

[0042] In one or more embodiments, the first sleeve portion is sized to circumscribe the fractured bone over 180 degrees and is placed prior to placement of the second sleeve portion and optionally the one or more additional sleeve portions to allow complete circumscription of the fractured bone.

[0043] In one or more embodiments, the first sleeve portion is sized to surround the fractured bone over 180 degrees and be positioned beneath the fractured bone.

[0044] In one or more embodiments, the method further comprises adjusting the diameter of the produced sleeve to a given diameter.

[0045] In one or more embodiments, step (d) entails adjusting the diameter of the resulting sleeve so that at least some of the protrusions interface with the fractured bone.

[0046] In one or more embodiments, step (d) entails the use of a locking mechanism configured to allow fastening using one or more of: screws, straps, wires, zip ties, fasteners, flanges, cerclages, or combinations thereof.

[0047] In one or more embodiments, step (d) entails overlapping adjacent edges of the sleeve portions, thereby allowing the diameter of the sleeve to be adjusted and the sleeve to be secured.

[0048] In one or more embodiments, after step (d), the method further comprises removing the device from around the fractured bone.

[0049] In one or more embodiments, step (a) comprises surgically cutting tissue adjacent to the bone fracture.

[0050] In one or more embodiments, at least two sleeve portions are pre-designed and customized to adjust to the size of the fractured bone.

[0051] In one or more embodiments, the dimension is the diameter of the fractured bone.

[0052] In one or more embodiments, the fractured bone belongs to a non-human animal.

[0053] In one or more embodiments, the device is used for veterinary purposes.

[0054] In one or more embodiments, step (b) includes placing the first sleeve portion beneath the fractured bone.

[0055] In one or more embodiments, step (b) includes positioning the first sleeve portion such that the first sleeve portion is located beneath the fractured bone (ie, distal to the incision made to allow access to the fractured bone).

[0056] In one or more embodiments, step (b) includes positioning the second sleeve portion such that the second sleeve portion is located above the fractured bone (ie, proximal relative to a cut made to allow access to the fractured bone).

[0057] In one or more embodiments, the method further includes placing a membrane beneath the sleeve portion, wherein the membrane includes bone growth factors, bone growth hormones, bone growth minerals (e.g., calcium), bone cells and / or stem cells that can be released into the bone and help accelerate healing.

[0058] In one or more embodiments, the membrane is placed under the sleeve portion before or after the sleeve portion is placed around the fractured bone. BRIEF DESCRIPTION OF THE DRAWINGS

[0059] The present invention may be more clearly understood after reading the following detailed description of non-limiting exemplary embodiments of the present invention with reference to the following drawings, in which:

[0060] Figure 1 is a perspective exploded view of a bone fracture repair device according to one example of the presently disclosed subject matter.

[0061] Figure 2 yes Figure 1 Perspective view of a bone fracture repair device.

[0062] Figure 3 yes Figure 1 A front perspective view of a bone fracture repair device with a magnified area thereof.

[0063] Figure 4 yes Figure 1 An end view of a bone fracture repair device with a magnified area thereof.

[0064] Figure 5A yes Figure 1 A perspective view of the device with its first sleeve portion wrapped around a fractured bone.

[0065] Figure 5B yes Figure 1 A perspective view of the device when the first sleeve portion and the second sleeve portion completely surround the fractured bone. DETAILED DESCRIPTION

[0066] The present invention may be more clearly understood upon reading the following detailed description of non-limiting exemplary embodiments of the present invention with reference to the accompanying drawings.

[0067] The following detailed description of embodiments of the present invention refers to the above-mentioned drawings. The dimensions of the components and features shown in the figures are selected for convenience or clarity of presentation and are not necessarily shown to scale. Wherever possible, the same reference numerals will be used throughout the drawings and the following description to refer to the same and similar parts.

[0068] Illustrative embodiments of the invention are described below. For the sake of clarity, not all features / components of an actual implementation are necessarily described.

[0069] The present invention relates to a bone fracture fixation device for repositioning a fractured bone, the device being designed with a sleeve configured to completely or substantially completely surround the fractured bone when the device is in use.

[0070] The term "broken bone" may relate to any type of fracture of a bone of a vertebrate organism. The vertebrate organism may include, but is not limited to, humans, primates (e.g., monkeys), canines (e.g., dogs), horses, felines (e.g., cats), birds, and ruminants (e.g., cattle, sheep, camels). The types of bones associated with the present invention are typically longitudinal bones or radial bones, which may include, but are not limited to, femurs, radius, humeri, vertebrae, and ribs. The types of fractures that may be fixed by the devices and methods of the present invention include, but are not limited to, hairline, greenstick, oblique (displaced or non-displaced), linear, transverse, comminuted, spiral, or segmental.

[0071] The term "completely surrounds the fractured bone" refers to a periphery surrounding the portion of the bone adjacent to the fracture. It should not be interpreted as necessarily surrounding the entire length of the bone, but rather at least partially surrounding the fractured area of ​​the bone.

[0072] The term "substantially completely surrounds the fractured bone" means surrounds more than 80%, 90%, 95% or 99% of the circumference around the portion of the bone adjacent to the fracture.

[0073] The sleeve comprises at least two sleeve parts which completely surround or encase the fracture when coupled to each other. In an embodiment of the invention, the device comprises a first sleeve part which is configured to surround more than 180 degrees.

[0074] In an exemplary embodiment, the device comprises two sleeve portions that completely surround the fracture when coupled to each other.

[0075] In one embodiment of the invention, the sleeve portions are of equal length. In an alternative embodiment, the sleeve portions have different lengths.

[0076] In one embodiment of the invention, the device comprises a second sleeve portion which complements the first sleeve portion. The complementary portions may be designed so that they do not have to be precisely adapted to each other in order to connect and form the sleeve. The portions may translate slightly relative to the other portion, allowing the operator some freedom to personalize and adapt the final structure of the sleeve to the individual fractured bone being treated. This may be achieved, for example, by a large slot in the locking mechanism of each portion through which a fastener is inserted to connect the two portions together.

[0077] In an embodiment of the present invention, one or more additional sleeve portions are further contemplated, such that all sleeve portions together completely or substantially completely surround the fractured bone when the device is in use.

[0078] As shown below, the first sleeve portion may be referred to as the main sleeve portion or the larger of the two portions because it encompasses more than 180 degrees of the fractured bone when the device is in use, or alternatively, it defines an arc greater than 180 degrees relative to a given diameter. For example, the first sleeve portion encompasses more than 190 degrees, greater than 210 degrees, greater than 230 degrees, greater than 250 degrees, greater than 270 degrees, greater than 300 degrees, or greater than 330 degrees of the fractured bone when the device is in use; or defines an arc greater than 190 degrees, greater than 210 degrees, greater than 230 degrees, greater than 250 degrees, greater than 270 degrees, greater than 300 degrees, or greater than 330 degrees relative to a given diameter. In one embodiment, the first sleeve portion encompasses at least 270 degrees of the fractured bone when the device is in use or defines an arc relative to at least 270 degrees of a given diameter. In one embodiment, the first sleeve portion encompasses at least 300 degrees of the fractured bone when the device is in use or defines an arc at least 300 degrees relative to a given diameter. In some embodiments, the second part (being a smaller part) of the sleeve completes the first part (being a larger part) so that the combination of the two parts surrounds 360 degrees or close to 360 degrees around the fractured bone. The smaller part can be defined as an arc that limits the arc of the main part to be completed to 360 degrees or close to 360 degrees. For example, in some embodiments, respectively, around the fractured bone, the main part of the sleeve surrounds 210 degrees, and the smaller part of the sleeve surrounds 150 degrees (when the diameter of the bone is equal to or less than the diameter of the arc defined by each part in the part). In some embodiments, respectively, around the fractured bone, the first part of the sleeve surrounds 270 degrees, and the second part of the sleeve surrounds 90 degrees (when the diameter of the bone is equal to or less than the diameter of the arc defined by each part in the part). The given diameter of the sleeve defined by the two parts is selected according to the bone intended to be fixed when the two parts are attached. For example, the sleeve for the fractured femur of a cat is designed to have a diameter between 8-20mm, or more specifically 10-15mm.

[0079] In some embodiments, there can be some overlap between the two sleeve portions, for example, the first sleeve portion can wrap around the fractured bone 270 degrees and the second sleeve portion can wrap around the fractured bone 120 degrees, so that there is a 30 degree overlap between the two sleeve portions at each end of the portions.

[0080] In some embodiments, the diameter of the fractured bone can be greater than the diameter of the arc defined by the two parts of the fixture. In such cases, the two parts can surround only a portion of the periphery of the fractured bone. For example, the arc defined by the two parts of the device can be 1 cm, and the average diameter of the bone can be 1.5 cm. In this case, the two parts of the device will surround the periphery of the fractured bone by about 240 degrees, while the remaining 120 degrees of the periphery of the bone will remain exposed.

[0081] In one embodiment, the device consists of a first sleeve portion and a second sleeve portion, in which case the combination of the first sleeve portion and the second sleeve portion surrounds the fractured bone 360 ​​degrees when the device is in use.

[0082] The sleeve may include a plurality of protrusions that are attached to or extend from the inner wall of the sleeve when the device is in use to press on the fractured bone and fix the bone in place. The protrusions define a space between the bone and the inner wall of the sleeve. Various forms of protrusions are envisioned. For example, the protrusions may have a sharp or blunt tip.

[0083] The projections may be placed at various locations as long as they protrude from the inner wall of the sleeve portion. The projections may be placed at random locations within the inner wall of the sleeve portion. The projections may be dispersed along the entire inner wall of the sleeve to compress the bone from opposite directions. Alternatively, the projections may be dispersed at opposite ends of the sleeve, i.e. near the orifices of the sleeve, and the projections may be dispersed near each orifice.

[0084] For example, the central portion of the sleeve may have no protrusions, and the protrusions are dispersed close to the orifice of the sleeve so that the sleeve portion surrounding the fracture has no protrusions. In some embodiments, the edge of about 1mm, 2mm, 3mm, 5mm or 1cm around the fracture has no protrusions.

[0085] The projection is made of a rigid or semi-rigid material, which is the same or different from the material of the sleeve. The sleeve and / or projection can be made of various materials, such as titanium, titanium alloy (e.g., Ti-6Al-7Nb, Ti-6Al-4V), stainless steel (e.g., 316L), cobalt-based alloy, bioceramics (e.g., Al2O3, ZrO2), tantalum (particularly tantalum with a porous structure), magnesium-based alloy, composite material (e.g., carbon fiber reinforced polymer, CFRP) and polymer (e.g., bone, ultra-high molecular weight polyethylene or UHMWPE). Polymer can be non-resorbable or bioresorbable. The projection can be made of bioinert materials, because these bioinert materials are the parts of the sleeve that should be in contact with bone. The sleeve and / or projection can be made of biodegradable materials such as magnesium-based alloys.

[0086] The sleeve and sleeve portions may include a plurality of pores that allow nutrients and / or cells to pass through, thereby helping to accelerate healing of fractured bone.

[0087] Optionally, the combined area of ​​the plurality of apertures accounts for 20% to 60% of the area of ​​the sleeve. For example, the combined area of ​​the plurality of apertures accounts for at least 10%, at least 20%, at least 30%, at least 40%, or at least 50%. For example, the combined area of ​​the plurality of apertures accounts for no more than 20%, no more than 30%, no more than 40%, no more than 50%, or no more than 60%.

[0088] The sleeve parts comprise an inter-sleeve part locking mechanism for allowing closing of the sleeve.

[0089] Various locking mechanisms are contemplated including, for example, one or more of: screws, straps, wires, zip ties, fasteners, flanges, cerclages, complementary interlocking grooves, and protrusions (serrations) on each portion, or combinations thereof.

[0090] The locking mechanism may be configured to allow the sleeve to be closed to a given diameter. In one example, the locking mechanism includes cooperating adjacent edges of the sleeve portions for allowing the sleeve portions to overlap, thereby allowing the diameter of the sleeve to be adjusted. The locking mechanism may include a diameter adjustment fixing fastener including an adjustable strap / wire / tie for setting the sleeve diameter. The locking mechanism may include a fastener configured to attach overlapping sleeve regions.

[0091] Bone growth factors can be added to one or more of the sleeve portion and / or the projections to help accelerate healing. The bone growth factors can include bone growth hormone, stem cells, bone growth minerals (e.g., calcium, particularly amorphous calcium, calcium phosphate cement, simvastatin salts, strontium salts, silicones, and combinations thereof) and / or bone cells (e.g., osteoblasts, bone marrow concentrate).

[0092] Device can optionally include inner membrane.Membrane can be placed in the inner surface of one or more sleeve parts.Membrane can include bone growth factor, bone growth hormone, stem cell, bone growth mineral (such as calcium, particularly amorphous calcium, calcium phosphate cement) and / or osteocyte that can be released into bone and help accelerate healing.Membrane can be attached to the inner side (intended to face the side of fractured bone) of one or more sleeve parts, or be provided to provider (such as in the kit including sleeve together with membrane) separately, thereby allow practitioner to attach membrane directly to fractured bone before device is applied to fractured bone.

[0093] Optionally, one or more elements (e.g., one or more sleeve portions) of the device can be customized to adapt to the size of the fractured bone. That is, the fractured bone of the patient can be visualized and measured using, for example, X-rays, CT or MRI scans, and one or more sleeve portions can be manufactured according to the size (diameter and / or length) of the fractured bone measured and / or the size of the fracture itself. Alternatively or in addition, one or more elements (e.g., one or more sleeve portions) of the device can be manufactured in various fixed sizes to adapt to various patients of different ages and / or sexes and / or with different sizes.

[0094] Figure 1 An exemplary bone fracture fixation device 10 is shown, which includes two sleeve portions, a first sleeve portion that constitutes a primary sleeve portion 12 and a second secondary sleeve portion 14. The sleeve portions 12 and 14 together form a complete sleeve that is configured to completely or substantially completely surround the fractured bone. Although shown as having equal lengths, sleeve portions 12 and 14 of different lengths are also contemplated herein. Each sleeve portion 12 and 14 includes a plurality of pores 16, typically a plurality of pores, which are used to allow nutrients to flow into the area of ​​the fractured bone to assist in the healing process. The first sleeve portion 12 and the second sleeve portion 14 each include a pair of mating flanges 18 along their edges, which are used to allow the sleeve portions to be attached to each other ( Figure 2 and Figure 3 , which shows the sleeve parts fastened to each other by fasteners 20 through flange through holes 22, which may be teardrop shaped).

[0095] Optionally or alternatively, the sleeve portions 12, 14 can be attached to each other using a band, a cerclage wire or other such fastening mechanisms. Optionally or alternatively, the sleeve portions 12, 14 can have edges that are configured to overlap, as opposed to having flanges 18, to allow the inner diameter of the adjustment device 10 to be adjusted, thereby providing flexibility in pressure on the fractured bone and allowing adjustment based on the size of the bone. Optionally or alternatively, the sleeve portions 12, 14 have a clamshell configuration with a hinge. The advantage of such embodiments is that the two parts are already connected along the hinge, and only the two parts need to be attached along one edge. The asymmetry between the two sleeve portions allows the free edge of the larger portion to be inserted under the fractured bone, and then the hinged edge is inserted under the fractured bone, while leaving the smaller portion outside the open wound, and the clamshell is closed only after the free edge of the larger sleeve portion emerges from the other side of the fractured bone. In some embodiments, due to space limitations, the sleeve portion is hingeless.

[0096] Figure 3 An exemplary enlarged hole 22 is shown, which may include a wider portion 25 that allows a fastener 20 to be inserted therethrough. Adjacent to the wider hole portion 25 is a narrower portion 27 having an internal thread 23 that allows a fastener (here a screw 20) to be fastened to the narrower portion and thereby fix the first sleeve portion 12 to the second sleeve portion 14. The flange 18 may protrude outwardly from the sleeve portions 12 and 14 at an angle that allows full attachment between the sleeve portions 12 and 14. The flange 18 may include several holes 22 along its length that are used to enable attachment between the sleeve portions 12 and 14 at various locations. The plurality of holes provides translational freedom for the two sleeve portions to mate relative to each other (i.e., the last two holes of the first portion 12 may face the two holes of the second portion 14 of the sleeve that are changed). This degree of freedom may allow the device to be implemented under in-situ spatial constraints where freedom is required (i.e., in clinical situations where little space is allowed to manipulate the device).

[0097] Figure 4 An end view of the device 10 in a closed (bone fixation / reduction) position and an enlargement of a section of the end view are shown, the end view showing a plurality of inwardly facing bone fixation projections 24, at least some of which are used to interface with the fractured bone. The inwardly facing bone fixation projections 24 are configured and sized to fix the device 10 to the fractured bone and provide space between the fractured bone and the sleeve portions 12, 14.

[0098] The projection 24 may be integrally formed with or fixed to the sleeve portions 12, 14. The projection 24 may have a tip 26, which may be sharp. Round or flat projections 24 are also contemplated herein and may be used. The projection 24 may contain bone growth factors / growth hormones / calcium / stem cells for release into the fractured bone to accelerate healing.

[0099] The sleeve portions 12, 14 and / or the bone fixation projections 24 can be made of a semi-rigid material to allow better contact with the fractured bone and micro-movement of the fractured bone. Optionally or alternatively, the device 10 can include three or more sleeve portions, one of which defines that the device encompasses the fractured bone by at least 180 degrees.

[0100] During placement of the device 10 at the bone fracture site, it is preferred that the primary sleeve portion 12 is located distal to the surgical incision / below the fractured bone and the secondary sleeve portion 14 is located proximal to the surgical incision / above the fractured bone. However, the primary sleeve portion 12 may alternatively be positioned proximal to the surgical incision / above the fractured bone and the secondary sleeve portion 14 may be located distal to the surgical incision / below the fractured bone.

[0101] It should be understood that "distal / lower" also means that the main sleeve portion 12 is placed away from the surgical incision. It should be further understood that "proximal / upper" also means that the secondary sleeve portion 14 is placed closer to the surgical incision.

[0102] A method for fixing a broken bone of a human or non-human patient will now be described. The method comprises a first step (a) of providing a bone fracture fixation device with access to the broken bone; a second step (b) of placing a sleeve portion at least partially around the broken bone; a third step (c) of placing one or more additional sleeve portions around the broken bone to completely or substantially completely surround at least a portion of the broken bone; and a fourth step (d) of fastening the sleeve portions to each other. Optionally, prior to step (a), the broken bone is visualized and measured, and one or more sleeve portions are manufactured to accommodate the size (length and / or diameter) of the broken bone.

[0103] In a first step, providing access to a fractured bone with a bone fracture fixation device may include providing an incision in a skin area as is customary in the art, the incision being sufficient to insert a portion of the fractured bone fixation device into an organ containing the fractured bone. The size of the incision may need to be sufficient for manually inserting a portion of the fractured bone fixation device. As is customary in minimally invasive surgery, the incision may be minimal to allow insertion of a minimally invasive device, such as an arthroscope. In such cases, the arthroscope is designed to bring a portion of the fractured bone fixation device to a target position around the fractured bone. The fractured bone fixation device may be divided into a number of portions that allow the portion to be compatible with the size of the arthroscope.

[0104] In a second step, the method may comprise firstly surrounding the fractured bone by one of the sleeve parts over an extent of more than 180 degrees, and in particular wherein the sleeve part is placed under the fractured bone during step (b). In the context of the present invention, under the fractured bone means the side of the bone away from the surgical incision. Figure 5A As illustrated, the first sleeve portion 12 may be initially placed around the fractured bone so that the fractured bone region F faces the surgeon. Thus, the first sleeve portion 12, which is the majority, is inserted beneath the fractured bone and placed between the bone and the tissue beneath the bone, typically by sliding the first portion around the fractured bone from one side until the first portion engulfs the fractured bone and emerges from the other side. Figure 5B As illustrated, during step (c), the second secondary sleeve portion 14 is placed on top of the first sleeve portion 12 closer to the surgical incision in a manner that the sleeve portions 12 and 14 complement each other and completely or substantially completely surround the fractured bone. The asymmetry between the two portions of the sleeve enables the primary first portion 12 to be inserted as described above with minimal movement or stretching of adjacent tissues or organs, as compared to a device made of two equal portions. The method may also include adjusting the diameter of the resulting sleeve to a given diameter around the fractured bone.

[0105] The above-mentioned step (d) may require adjusting the diameter of the sleeve produced so that at least some of the protrusions interface with the fractured bone. Step (d) may also require the use of a locking mechanism configured to allow fastening using one or more of the following: screws, straps, wires, zip ties, fasteners, flanges, cerclages, or combinations thereof. Step (d) may optionally or alternatively require overlapping adjacent edges of the sleeve portions, thereby allowing the diameter of the sleeve to be adjusted and the sleeve to be secured. Optionally or alternatively, after step (d), the method may further include removing the device from around the fractured bone.

[0106] The above-mentioned step (a) may comprise surgically cutting tissue adjacent to the bone fracture.

[0107] The method may comprise using two sleeve parts that are pre-designed and manufactured to accommodate the size of the fractured bone. Alternatively, the method may comprise using an off-the-shelf device having a sleeve that has a fixed size that can match the diameter of the fractured bone. Alternatively or in addition to use in humans, the method may comprise using the device for veterinary purposes.

[0108] The above-mentioned step (b) may include placing the first sleeve portion such that the first sleeve portion is located distally or proximally to a surgical incision made during surgery to insert the sleeve portion into the body (inside the patient's body).

[0109] The method of the present invention can significantly reduce the duration of surgery. Compared with the surgery for fixing the fractured bone available in the prior art, the method can reduce the duration of the surgical procedure by 25%, 30%, 35%, 40%, 45% or even 50%. For example, the surgical procedure performed on a cat with a simple transverse proximal fracture of the femur may take no more than 20 minutes, 15 minutes or even 10 minutes.

[0110] In a further aspect, the invention provides a use of a bone fracture fixation device of the invention for treating a patient in need thereof according to the method of the invention. The patient may be human or non-human, ie the use may be for medical treatment and / or for veterinary treatment.

[0111] Each of the following terms: as used herein, "includes", "including", "has", "having", "comprises" and "comprising" and language equivalents thereof mean "including, but not limited to", and should be construed as specifying stated components, features, characteristics, parameters, integers or steps, and do not preclude the addition of one or more additional components, features, characteristics, parameters, integers, steps or groups thereof.

[0112] As used herein, the term "consisting essentially of is meant to limit the scope of a claim to the specified elements and those elements that do not materially affect the basic and novel characteristics of the claimed device and material.

[0113] As used herein, each of the phrases "consisting of" and "consists of" means "including and limited to."

[0114] As used herein, the term "method" refers to steps, procedures, ways, means and / or techniques for completing a given task, including but not limited to those steps, procedures, ways, means and / or techniques that are known to practitioners in the relevant field of the disclosed invention or that are easily developed from known steps, procedures, ways, means and / or techniques.

[0115] Throughout the disclosure, the numerical value of a parameter, feature, characteristic, object or size can be stated or described with a numerical range format. As used herein, such numerical range format shows the embodiments of some exemplary embodiments of the present invention, and does not rigidly limit the scope of exemplary embodiments of the present invention. Therefore, the numerical range stated or described also refers to and encompasses all possible subranges and individual numerical values ​​(wherein numerical values ​​can be expressed as complete numbers, integers or fractions) in the numerical range stated or described. For example, the numerical range of '1 to 6' stated or described also refers to and encompasses all possible subranges, such as '1 to 3', '1 to 4', '1 to 5', '2 to 4', '2 to 6', '3 to 6', etc., and individual numerical values ​​in the numerical range of '1 to 6' stated or described, such as '1', '1.3', '2', '2.8', '3', '3.5', '4', '4.6', '5', '5.2' and '6'. Regardless of the numerical width, degree or size of the numerical range stated or described, this applies.

[0116] All ranges disclosed herein are inclusive of the endpoints.Use of the term "or" should be interpreted to mean "and / or" unless the specific context indicates otherwise.

[0117] In addition, for the purpose of stating or describing a numerical range, the phrase "in the range between about a first value and about a second value" is considered equivalent to the phrase "in the range from about a first value to about a second value" and has the same meaning, and therefore, these two equivalent phrases can be used interchangeably.

[0118] In some embodiments, the term "about" refers to ±30% of the stated value. In other embodiments, the term refers to ±20% of the stated value. In yet other embodiments, the term refers to ±10% of the stated value.

[0119] It should be fully understood that certain aspects, features, and characteristics of the invention that are illustratively described and presented in the context or format of multiple separate embodiments for clarity may also be illustratively described and presented in the context or format of a single embodiment in any suitable combination or subcombination. Conversely, various aspects, features, and characteristics of the invention that are illustratively described and presented in the context or format of a single embodiment in combination or subcombination may also be illustratively described and presented in the context or format of multiple separate embodiments.

[0120] Although the present invention has been described in conjunction with specific embodiments thereof, it is apparent that many alternatives, modifications and variations will be apparent to those skilled in the art. Therefore, it is intended to encompass all such alternatives, modifications and variations that fall within the broad scope of the appended claims.

[0121] All disclosures, patents, and patent applications referred to in this specification are hereby incorporated by reference in their entirety into this specification, to the same extent as if each individual disclosure, patent, or patent application was specifically and individually indicated to be incorporated by reference herein. In addition, the citation or identification of any reference in this application should not be interpreted as an admission that this reference is available as prior art to the present invention. In the sense that section headings are used, they should not be interpreted as necessarily limiting.

[0122] Example 1

[0123] An exemplary procedure according to the invention is given below, as can be demonstrated using X-ray and still images.

[0124] Cats with an injured femur with a central transverse fracture may be treated in the following ways:

[0125] 1. Give the cat isoflurane anesthesia

[0126] 2. The skin above the fractured femur can be disinfected and then a 4 cm long incision can be made to provide access for the fracture fixation device to approach the fractured bone;

[0127] 3. Fix the broken pieces together;

[0128] 4. A first sleeve portion of a 200 degree arc with a diameter of 1 cm and a length of 10.4 mm can be positioned around the fractured bone on the side away from the incision;

[0129] 5. A second sleeve portion of a 160 degree arc with a diameter of 1 cm can be positioned around the fractured bone on the side proximal to the incision to completely surround the portion of the fractured bone containing the fracture and the margins a few centimeters above and below the fracture, or in the case where the bone diameter is 1 cm larger than the diameter of the two articular arcs, a portion of the fractured bone can then be exposed;

[0130] 6. The sleeve parts can be fastened to each other by four cerclages;

[0131] 7. Routine examination ends the surgery;

[0132] 8. Cats can be given dipyrone and amoxicillin for one week.

[0133] The duration of the surgery can last about 10 to 15 minutes. The cat can put weight on the foot 2 days after surgery and walk freely 5 days after surgery. This example can prove the feasibility of the device and surgery to speed up recovery and shorten the operation time for the surgeon.

Claims

1. A bone fracture fixation device for resetting a fractured bone, the device comprising: A sleeve having dimensions for completely or substantially completely surrounding at least one section of the fractured bone containing the fracture, the sleeve comprising: At least two sleeve parts, wherein the first sleeve part has a dimension for surrounding more than 180 degrees around the broken bone, and the second sleeve part and optionally one or more further sleeve parts supplement the first sleeve part, thereby completely or substantially completely surrounding the broken bone when the device is in use.

2. The device of claim 1, wherein the first sleeve portion surrounds the fractured bone by greater than 210 degrees, greater than 230 degrees, greater than 250 degrees, or greater than 270 degrees when the device is in use.

3. The device of claim 2, wherein the first sleeve portion surrounds the fractured bone by at least 270 degrees when the device is in use.

4. The device of claim 1, comprising a first sleeve portion and a second sleeve portion, wherein the first sleeve portion and the second sleeve portion surround 360 degrees around the fractured bone when the device is in use.

5. The device of claim 1, wherein the sleeve further comprises a plurality of protrusions attached to or extending from an inner wall of the sleeve when the device is in use to press on the fractured bone and secure the bone in place.

6. The device of claim 5, wherein the protrusion has a sharp or blunt tip.

7. The device of claim 5, wherein the protrusions are dispersed along the entire inner wall of the sleeve.

8. The device of claim 5, wherein the protrusions are dispersed over two or more portions of the sleeve.

9. The device of claim 5, wherein the sleeve includes two apertures through which the fractured bone passes when the device is in use, and the projections are dispersed proximate each of the apertures.

10. The device of claim 9, wherein a central portion of the inner wall of the sleeve proximal to the fracture is free of protrusions.

11. The device of claim 1, wherein the projection defines a space between the bone and the sleeve.

12. The device of claim 1, wherein the protrusion is made of a rigid or semi-rigid material that is the same as or different from the material of the sleeve.

13. The device of claim 1, wherein the sleeve portion includes a plurality of pores for allowing nutrients and / or cells to pass therethrough to help accelerate healing of the fractured bone.

14. The device of claim 1, wherein a combined area of ​​the plurality of apertures is between 20% and 60% of an area of ​​the sleeve.

15. The device of claim 1, wherein the sleeve portion includes an inter-sleeve portion locking mechanism for allowing closure of the sleeve.

16. The device of claim 15, wherein the locking mechanism comprises one or more of: a screw, a strap, a wire, a zip tie, a fastener, a flange, a cerclage, or a combination thereof.

17. The device of claim 15, wherein the locking mechanism is configured to allow closing or at least partial closing of the sleeve to a given diameter.

18. The device of claim 17, wherein the locking mechanism comprises cooperating adjacent edges of the sleeve portions, the cooperating adjacent edges being adapted to allow the sleeve portions to overlap, thereby allowing adjustment of the diameter of the sleeve.

19. The device of claim 17, wherein the mechanism comprises a diameter adjustment fixing fastener comprising an adjustable strap / wire / tie for setting the sleeve diameter; or a through-the-tube fastener configured to attach overlapping sleeve regions.

20. The device of claim 1, wherein one or more of the sleeve portion and / or the protrusions include bone growth factors, bone growth hormones, bone growth minerals (e.g., calcium), bone cells and / or stem cells that can be released into the bone and help accelerate healing.

21. The device of claim 1, further comprising a membrane disposed in the inner surface of one or more sleeve portions, the membrane comprising bone growth factors, bone growth hormones, bone growth minerals (e.g., calcium), bone cells and / or stem cells that can be released into the bone and help accelerate healing.

22. The device of claim 1, wherein the two sleeve portions have different lengths.

23. The device of claim 1, wherein the two sleeve portions are equal in length.

24. A method of fixing a fractured bone in a human or non-human patient, the method comprising: (a) providing access to the fractured bone for a bone fracture fixation device as defined in any one of the preceding claims; (b) placing a first sleeve portion at least partially around the fractured bone; (c) placing a second sleeve portion and optionally one or more further sleeve portions around the fractured bone to completely or substantially completely surround at least a portion of the fractured bone; and (d) fastening the sleeve parts to each other.

25. The method of claim 24, wherein the first sleeve portion is sized to surround the fractured bone over 180 degrees and is placed prior to placing the second sleeve portion and optionally the one or more additional sleeve portions to allow complete enclosure of the fractured bone.

26. The method of claim 24, wherein the first sleeve portion is sized to surround the fractured bone over 180 degrees and is positioned beneath the fractured bone.

27. The method of claim 24, further comprising adjusting the diameter of the produced sleeve to a given diameter.

28. The method of claim 24, wherein step (d) entails adjusting the diameter of the resulting sleeve so that at least some of the projections interface with the fractured bone.

29. The method of claim 24, wherein step (d) requires the use of a locking mechanism configured to allow fastening using one or more of: screws, straps, wires, zip ties, fasteners, flanges, cerclages, or combinations thereof.

30. The method of claim 24, wherein step (d) entails overlapping adjacent edges of the sleeve portions, thereby allowing adjustment of the sleeve diameter and securing the sleeve.

31. The method of claim 24, wherein after step (d), the method further comprises removing the device from around the fractured bone.

32. The method of claim 24, wherein step (a) comprises surgically cutting tissue adjacent to the bone fracture.

33. The method of claim 24, wherein at least two sleeve portions are pre-designed and customized based on imaging diagnosis to adjust the size of the fractured bone.

34. The method of claim 33, wherein the dimension is the diameter of the fractured bone.

35. The method of claim 24, wherein the fractured bone belongs to a non-human animal.

36. The method of claim 24 for veterinary purposes.

37. The method of claim 24, wherein step (b) comprises placing the first sleeve portion beneath the fractured bone.

38. The method of claim 24, wherein step (b) comprises positioning the first sleeve portion such that the first sleeve portion is distal or proximal to a surgical incision.

39. The method of claim 24, wherein step (b) comprises positioning the first sleeve portion such that the first sleeve portion is proximal to a surgical incision.

40. The method of claim 24, further comprising placing a membrane on a side of the sleeve portion facing the fractured bone or directly on the fractured bone, wherein the membrane comprises bone growth factors, bone growth hormones, bone growth minerals (e.g., calcium), stem cells and / or bone cells that can be released into the bone and help accelerate healing.

41. The method of claim 40, wherein the membrane is placed beneath the sleeve portion prior to placing the sleeve portion around the fractured bone.

42. Use of a bone fracture fixation device according to any one of claims 1 to 23 for treating a patient in need thereof according to the method of any one of claims 24 to 41, wherein the patient is human or non-human.

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