Injectable tissue repair device and method of making same

Abstract

Tissue repair devices, methods of manufacturing such devices, and methods of using such devices are disclosed. In one embodiment, a tissue repair device includes a pellet of porous, compressible tissue repair material that can be provided and subsequently hydrated in a barrel of a syringe. In one embodiment, the tissue repair material is configured in the barrel of the syringe such that an elongated channel exists, the channel being defined by the inner wall of the barrel and the tissue repair material.

Description

Technical Field

[0001] The disclosed invention relates to an injectable tissue repair device, a method for manufacturing such a device, and a method of using such a device. The tissue repair device can be used to repair bone defects. Background Technology

[0002] Medical products used to repair tissue defects come in various forms and have a variety of uses. One such medical product is a bone void filler in the form of a three-dimensional sponge. The sponge is typically in the form of a freeze-dried composition of a natural polymer. The sponge can be hydrated, which makes it flexible. The hydrated fluid can take many forms. Examples of hydrated fluids are sterile water, whole blood, platelet-rich plasma (PRP), and bone marrow aspirate. Once the material becomes flexible, it can be manually placed directly into the bone defect or dispensed into the bone defect using a syringe.

[0003] Such sponges are typically formed by first creating a slurry containing particles or fibers of water and a biocompatible polymer. The slurry may further contain minerals, such as those known to promote bone growth. Examples of such minerals are hydroxyapatite, calcium phosphate, bioactive glass, bone particles, and mixtures thereof. The slurry is dispensed into a mold. The mold and slurry are then placed together in a freeze dryer, and the slurry is freeze-dried to produce the sponge. The sponge is then separated from the mold. Post-treatment, such as machining, can be performed before packaging and sterilization to ensure a suitable surface smoothness.

[0004] Over the years, advancements in medical products for treating tissue defects have consistently improved ease of use. One such advancement is the provision of medical products in a form that allows attending physicians to easily hydrate them. One such commercially available product is... Provided Putty. The product is a disc-shaped sponge made from a freeze-dried composition of approximately 80% by weight minerals and 20% by weight type I bovine collagen. The minerals are present in granular form throughout the sponge. Based on the total weight of the granules, the mineral granules contain approximately 15% by weight hydroxyapatite and 85% by weight β-tricalcium phosphate.

[0005] Putty sponges are disc-shaped with reservoirs to hold hydration fluid. These reservoirs are formed by peripheral sidewalls and recessed surfaces. The product has a rectangular cross-section. To use this material, the physician dispenses a prescribed amount of hydration fluid directly into the disc. This has the advantage of using the correct amount of hydration fluid and preventing it from flowing from the sponge onto other surfaces. The physician then manipulates the material manually or with tools to hydrate the sponge evenly with the hydration fluid.

[0006] US7824703 discloses another such medical article. This disclosure describes a medically usable article comprising a three-dimensional body including one or more implantable materials, wherein the body defines one or more reservoirs for receiving a quantity of biocompatible wetting fluid. In some embodiments, the body may rupture upon wetting with the biocompatible fluid to form a conformable implantable material, such as putty, paste, or a more flowable wetting implantable material.

[0007] Once fully hydrated, the tissue repair device can be inserted into the tissue defect manually or with the aid of a syringe. The use of a syringe allows surgeons to place the tissue repair device more accurately, especially when the tissue defect is concave or a narrow cleft. Therefore, many surgeons prefer to insert the hydrated tissue repair device into the tissue defect via a syringe. Summary of the Invention

[0008] One drawback of the aforementioned tissue repair device is the extensive pretreatment required before insertion into the tissue defect. For example, hydration fluid must first be measured and dispensed onto the device. Secondly, the hydration fluid must be introduced into the device to ensure adequate and uniform hydration. Next, the hydrated device is placed in the syringe barrel, possibly compacted, and then dispensed into the tissue defect.

[0009] Besides being inconvenient and potentially prolonging time in the operating room, the procedure may also introduce contamination. Furthermore, material may be lost when manufacturing the tissue repair device or inserting a hydrated tissue repair device into a syringe. Therefore, there is a need for a tissue repair device that can be stored, hydrated, and dispensed from a single syringe.

[0010] In one embodiment, the method for forming a tissue repair device includes the following steps:

[0011] a. Providing an syringe, the syringe comprising a barrel in fluid communication with a tip, the barrel including an inner wall and at least one elongated obstruction extending along the length of the barrel, the obstruction contacting or proximating the inner wall;

[0012] b. Inserting multiple porous, compressible tissue repair material pellets into a cylinder, the tissue repair material being extruded through a tip upon hydration; and

[0013] c. Remove the obstruction.

[0014] The tissue repair material pellets are porous and compressible. Due to their porous and compressible nature, the pellets will remain compressed after the compressive force is removed. Furthermore, the compressed material will not substantially fill the voids created by removing the blockage. In an embodiment, at least some of the plurality of pellets are compressed before the blockage is removed.

[0015] When the obstruction is removed, a channel-like opening exists along the length of the syringe adjacent to the inner wall where the obstruction was located. This channel is defined by the inner wall of the syringe and the tissue repair material. The tissue repair material can then be hydrated by dispensing and mixing a hydrating fluid (e.g., saline solution or blood) into the channel. After proper mixing, the tissue repair material can be extruded from the tip, for example, in the form of a flowable solution, gel, paste, or putty.

[0016] Compared to situations where blockages need to be retained in the cylinder during transport or hydration, the use of channels as described herein allows for the containment of more material within the cylinder. The described device is also lighter and generates less waste.

[0017] In contrast to hydration via channels defined on all sides of the tissue repair material, superior results can be obtained by hydration via the aforementioned channels. For example, the inventors have found that tissue repair materials can possess excellent characteristics, such as improved injectability, more uniform hydration, and superior dispensability. Furthermore, the disclosed embodiments can allow hydration via a tip, for example, by connecting a second syringe containing the hydration fluid to the tip of the syringe. The method of forming injectable tissue repair materials can also be improved relative to the prior art, for example by increasing speed or consistency, or reducing physical exertion. In some embodiments, mixing the hydration fluid and the tissue repair material is not required, thus allowing for a fully formed product, wherein the only step required to manufacture the extrudable tissue repair material is hydration via a tip.

[0018] Tissue repair devices are also disclosed. In one embodiment, the syringe includes a barrel in fluid communication with a tip, the barrel including an inner wall and a compressed porous tissue repair material present in the barrel, wherein the tissue repair device is configured such that at least one elongated channel extends along the length of the barrel through the tissue repair material, wherein the channel is defined by the inner wall and the tissue repair material.

[0019] In another embodiment, the tissue repair device may include an obstruction intended to be removed by a surgeon just before hydrating the device. Such a tissue repair device may contain compressed or uncompressed tissue repair material. If uncompressed, the surgeon should compress the tissue repair material and subsequently remove the obstruction before hydration. Thus, in one embodiment, the tissue repair device includes a syringe comprising a barrel in fluid communication with a tip, the barrel including an inner wall, a porous tissue repair material present within the barrel, and an elongated obstruction in contact with the inner wall and otherwise surrounded by the tissue repair material. In one embodiment, the tissue repair material is present as pellets. In another embodiment, the tissue repair material is compressed.

[0020] The tissue repair device can be used by hydrating and injecting hydrated tissue repair material. In an embodiment, tissue defects in a human or animal can be treated by performing the following steps:

[0021] a. Providing an syringe comprising a barrel in fluid communication with a tip, the barrel including an inner wall, a tissue repair material, and at least one elongated channel extending along the length of the barrel, the channel being defined by the inner wall and the tissue repair material, wherein the tissue repair material is porous and compressible;

[0022] b. Insert the hydrated fluid into the channel to form an extrudable tissue repair material.

[0023] The method may also include the step of extruding an extrudable tissue repair material into the tissue of a human or animal body, for example by injection from a syringe.

[0024] Various further benefits can be obtained by applying the methods described herein and forming tissue repair devices, including fewer part defects, lower scrap rates, increased manufacturing output, lower manufacturing costs, shorter post-processing times, greater flexibility in material composition and mineral loading in slurries, improved mechanical properties of tissue repair materials, greater consistency in final disposal properties after hydration, lower likelihood of fluid leakage, and improved ease of use. Attached Figure Description

[0025] Figure 1 This is a side view of the syringe including the obstruction.

[0026] Figure 2 This is a top view of the syringe, including the obstruction.

[0027] Figure 3 This is a top view of a syringe containing channels and tissue repair materials. Detailed Implementation

[0028] Throughout this application, the term tissue repair material refers to tissue repair material prior to hydration with a hydrating fluid. Such tissue repair materials are typically not extrudable through the tip of a syringe or have very poor extrudability. When the terms extrudable tissue repair material, flowable tissue repair material, or hydrated tissue repair material are used, the terms refer to tissue repair material after hydration by combining with and mixing the tissue repair material and the hydrating fluid.

[0029] The term tissue repair device refers to a medical device containing tissue repair material. In one embodiment, the methods and tissue repair devices described herein include a syringe. The syringe may have any suitable form and typically includes a barrel and a tip. The tip may be a needle, but a low-gauge tip (larger diameter) may be most suitable due to the fluidity of typical tissue repair materials in their hydrated state.

[0030] In one implementation, a syringe barrel is used to prepare tissue repair material for injection. Typically, the barrel has a circular cross-section and is cylindrical or truncated conical in shape. The appropriate barrel size usually depends on the diameter of the tip and the amount of tissue repair material required. After preparing the tissue repair material, a plunger can be inserted into the proximal end of the barrel, and extruded tissue repair material from the tip.

[0031] The tissue repair material is porous. Pores can be formed by various methods, including leaving pores by using a gas, a liquid, or a thermally unstable porogen removed from the tissue repair material. For example, the tissue repair material can be degassed under vacuum, thereby creating pores as the gas expands within the tissue repair material due to the pressure reduction. In embodiments, pores are formed in the tissue repair material by lyophilizing a slurry, in which case a liquid (typically water) acts as a porogen.

[0032] In one embodiment, the tissue repair material comprises porous, compressible pellets. In one embodiment, the pellets comprise a sponge. As described herein, a suitable sponge can be formed by filling a mold with a slurry and freeze-drying the slurry in the mold. In one embodiment, the slurry comprises water and polymer fibers. The polymer fibers are preferably natural polymer fibers. Examples of polymer fibers are fibers of collagen, chitosan, alginate, or hyaluronic acid. The fibers are preferably hydrophilic.

[0033] In one embodiment, the tissue repair material comprises polymer fibers. In one embodiment, the tissue repair material comprises collagen fibers. Collagen fibers are fibers of collagen and are insoluble in an aqueous liquid with a pH of 3.5. In one embodiment, the collagen fibers are natural collagen fibers, not reconstituted collagen fibers. In one embodiment, the average length of the polymer fibers is from 1 mm to 15 mm. In one embodiment, the average length of the polymer fibers is from 0.5 mm to 10 mm. In one embodiment, the average length of the polymer fibers is at least 0.5 mm, at least 1 mm, at least 2 mm, at least 3 mm, or at least 4 mm. In one embodiment, the average length of the polymer fibers is at most 15 mm, at most 12 mm, at most 10 mm, at most 9 mm, at most 8 mm, at most 7 mm, at most 6 mm, at most 5 mm, or at most 4 mm.

[0034] Natural collagen fibers can be 50 mm or longer. The length of collagen fibers can be controlled using known processing methods. For example, the average fiber length can be controlled by centrifuging collagen fibers using a cutting head with an appropriate gap size. A cutting head gap size of 5 mm produces an average fiber length of approximately 5 mm. If the centrifugal grinding cutting head gap size is unknown or substantially non-uniform, the average fiber length can be measured using an optical comparator or optical microscope.

[0035] In one embodiment, the tissue repair material further comprises acid-soluble collagen. Acid-soluble collagen is a form of collagen that is insoluble in an aqueous liquid at pH 6.5 but soluble in an aqueous liquid at pH 4. To dissolve the collagen in solution, the pH is driven down to between 2 and 4. However, once in solution, the pH can be raised to 6.5 without causing the collagen to precipitate from the solution. The acid-soluble collagen is introduced into the liquid as particles or powder to form a slurry.

[0036] In one embodiment, the acid-soluble collagen is processed without the aid of enzymes and is therefore a non-enzymatically processed acid-soluble collagen. Non-enzymatically processed acid-soluble collagen can be produced by grinding cleaned collagen source materials (e.g., leather or fur). Typically, the collagen used in this invention can be obtained from any suitable animal source, such as cattle, pigs, fish, sheep, goats, or other sources. The procollagen produced from non-enzymatic processing cannot undergo spontaneous fibrosis under physiological conditions.

[0037] In one embodiment, the weight ratio of collagen fibers to acid-soluble collagen in the tissue repair material is from 25:75 to 75:25. In another embodiment, based on the total amount of collagen in the tissue repair material, the tissue repair material comprises 10% to 75% by weight of acid-soluble collagen and 25% to 90% by weight of collagen fibers.

[0038] In one embodiment, the tissue repair material is manufactured by freeze-drying a composition comprising natural polymer fibers and optionally mineral particles. In one embodiment, the tissue repair material further comprises minerals. The minerals may be present as particles or fibers. After freeze-drying the slurry, the minerals are supported by and retained within the polymer fiber network. In one embodiment, the minerals are present as particles with an average particle size of 0.05 mm to 5 mm. In another embodiment, the minerals are present as particles with an average particle size of at least 0.05 mm, at least 0.1 mm, at least 0.2 mm, at least 0.3 mm, at least 0.4 mm, or at least 0.5 mm. In yet another embodiment, the minerals are present as particles with an average particle size of at most 5 mm, at most 4 mm, at most 3 mm, at most 2 mm, at most 1 mm, or at most 0.5 mm.

[0039] In one embodiment, the minerals include hydroxyapatite, bioactive glass, tricalcium phosphate (e.g., α-tricalcium phosphate or β-tricalcium phosphate), or bone particles. The bone particles may be inorganic bone particles, autologous bone particles, allogeneic bone particles, or xenogeneic bone particles, or combinations thereof. The minerals may be monophasic or biphasic. In one embodiment, based on the total weight of the tissue repair material, the tissue repair material comprises 65 wt%, 66 wt%, 67 wt%, 68 wt%, 69 wt%, 70 wt%, 71 wt%, 72 wt%, 73 wt%, 74 wt%, 75 wt%, 76 wt%, 77 wt%, 78 wt%, 79 wt%, or 80 wt% to 95 wt%, 94 wt%, 93 wt%, 92 wt%, 91 wt%, 90 wt%, 89 wt%, 88 wt%, 87 wt%, 86 wt%, or 85 wt% of minerals. In one embodiment, the tissue repair material comprises collagen and minerals, wherein the amount of collagen present, based on the total weight of the tissue repair material, is 5 wt%, 6 wt%, 7 wt%, 8 wt%, 9 wt%, 10 wt%, 11 wt%, 12 wt%, 13 wt%, 14 wt%, or 15 wt% to 30 wt%, 29 wt%, 28 wt%, 27 wt%, 26 wt%, 25 wt%, 24 wt%, 23 wt%, 22 wt%, 21 wt%, 20 wt%, 19 wt%, 18 wt%, 17 wt%, or 16 wt%.

[0040] In one embodiment, the slurry comprises water and polymer fibers. In another embodiment, the slurry further comprises other components, such as acid-soluble collagen or minerals. The working pH range of slurries containing collagen fibers and / or acid-soluble collagen is typically 2 to 8. In one embodiment, the pH of the slurry is 4.5 to 8. In one embodiment, the slurry further comprises an acid, a base, or a buffer. Typically, an acid or base is added to the slurry to bring it to the desired pH value. In the case of slurries containing collagen, the viscosity of the slurry depends on factors such as the pH value of the slurry, the fiber length of the collagen fibers, the ratio of fibrous collagen to soluble collagen, and the solids content of the slurry.

[0041] In one embodiment, the solids content of the slurry is from 2% to 30% by weight, based on the total weight of the slurry. Solids content refers to what remains after the liquid components of the slurry have been removed, for example, after lyophilization. In one embodiment, the solids content of the slurry is at least 2%, 5%, or 10% by weight, based on the total weight of the slurry. In one embodiment, the solids content of the slurry is at most 40%, 35%, 30%, 25%, 20%, 15%, or 10% by weight, based on the total weight of the slurry. The solids content of the slurry by weight is generally higher when minerals are present than when minerals are absent. In one embodiment, the slurry does not contain minerals and the solids content is from 2% to 10% by weight. In one embodiment, the slurry contains minerals and the solids content is from 10% to 40% by weight.

[0042] In one embodiment, the tissue repair device or tissue repair material further comprises a bioactive agent. The bioactive agent may be, for example, a steroid, an anti-inflammatory agent, an antibiotic, or another bioactive agent that can be used to treat wounds or inflammation. The bioactive agent may be present inside the sponge, for example, by immersing the sponge in the bioactive agent or by incorporating microparticles containing the bioactive agent during the formation of the sponge. The bioactive agent may also be present on the outer surface of the sponge by forming a coating on the exterior. The coating may be formed, for example, by dissolving the bioactive agent in a degradable synthetic polymer and coating the solution onto the outer surface of the sponge. Suitable degradable synthetic polymers may include polylactic acid (PLA), polyglycolic acid (PGA), poly(lactic acid-copolymer-glycolic acid) (PLGA), polycaprolactone (PCL), polyesteramide (PEA), or combinations thereof or copolymers thereof. In one embodiment, the bioactive agent is present in an hydrated fluid.

[0043] In one embodiment, a slurry is introduced into a mold and freeze-dried to form a sponge. This method of forming a sponge typically results in a sponge with randomly arranged fibers. After freeze-drying, the sponge may be cross-linked. In one embodiment, cross-linking is performed without the use of chemicals, for example by dehydrating and thermally cross-linking a collagen sponge. In one embodiment, cross-linking is performed using chemicals (e.g., glutaraldehyde).

[0044] The advantage of using pellets of tissue repair material is that various sizes of tissue repair devices can be formed using the same raw material; more or fewer pellets can be added to a cylinder to create tissue repair devices of different sizes. Pellets can be formed by molding or cutting sponge into pellets (e.g., using a laser or scalpel). In some embodiments, the pellets are molded. In some embodiments, the pellets include shapes such as triangular prisms, rectangular prisms, other polygonal prisms, or cylinders. A suitable pellet size can be selected based on the desired flow behavior of the hydrated fluid and the desired filling of the pellet around any obstruction. In some embodiments, a majority of the pellets have a volume of 250 mm². 3 200mm 3 150mm 3 125mm 3 100mm 3 75mm 3 50mm 3 or 40mm 3 Or smaller. In this embodiment, most of the pellets have a volume of 25 mm. 3 30mm 3 35mm 3 40mm 3 45mm 3 50mm 3 or 75mm 3 or larger volumes. In this embodiment, most of the pellets in the plurality of pellets have a volume of 30 mm. 3 Up to 50mm 3 .

[0045] In one embodiment, the pellet is sized such that it will pass through the tip. In one embodiment, the maximum size of the pellet is 6 mm or less, 5 mm or less, or 4 mm or less. In one embodiment, the maximum size of the pellet is less than the inner diameter of the tip.

[0046] Tissue repair devices are typically created by first inserting a blockage into the barrel of a syringe. Figure 1The image depicts a side view of a cross-section of such a syringe including two plugs. The syringe 1 includes a barrel 2 and a tip 3. The tip 3 is secured to the barrel 2 at a position 4. The barrel includes an inner wall 5. Elongated plugs 6 and 7 are located within the barrel 2. In an embodiment, the plugs are rods. In an embodiment, the barrel contains 1, 2, 3, 4, or 5 plugs. The elongated plugs 6 and 7 are inserted into the barrel in direction 8 until they reach the plunger 9. As depicted, each elongated plug 4, 5 contacts the inner wall 5 of the barrel 2 over substantially the entire length of the barrel. For example, if partial filling of the syringe is required, the plugs may be present for a length less than the entire length of the barrel. Typically, the syringe is partially filled by advancing the plunger distally to the desired volume and bringing the plugs 6 and 7 abutment against the plunger 9.

[0047] In one embodiment, an elongated plug is located near but not in contact with the inner wall of the syringe. The elongated plug is positioned to approach or contact the inner wall of the syringe. The plug may be connected to a filling cap positioned above the syringe to hold the plug in place while providing access to the cartridge for filling the cartridge with tissue repair material.

[0048] In one implementation, the channel occupies 1% to 10% of the total filling volume of the cylinder. Total filling volume refers to the volume of the cylinder that would be filled if it were fully filled. For example, if... Figure 1 The syringe shown has a total barrel capacity of 10 cc, and the plunger is advanced distally to reduce the capacity to 8 cc, whereupon an obstruction is inserted into the barrel. The barrel is then filled by adding and compressing tissue repair material, resulting in a total filling volume of 8 cc. In one embodiment, the channel occupies at least 1%, 1.5%, or 2% of the total filling volume of the barrel. In one embodiment, the channel occupies at most 10%, 9%, 8%, 7%, 6%, 5%, or 4% of the total filling volume of the barrel. In one embodiment, the channel occupies 1.5% to 4% of the total filling volume of the barrel.

[0049] The pellets are then added to the cartridge to achieve the desired amount of tissue repair material. In one embodiment, the syringe volume is from 1 cubic centimeter to 15 cubic centimeters. The syringe typically includes a cartridge and a tip. The tip can be a straight, curved, or angled cannula. In one embodiment, the tip includes a Luer lock to allow attachment of a hydration syringe for insertion of the hydration fluid into the cartridge. In one embodiment, the syringe is OsteoPrecision from Nordson Medical. TM Bone graft delivery device.

[0050] Adding an appropriate amount of pellets can compress the tissue repair material. For example, a tamper can be used, optionally having one or more holes for the obstruction to pass through. In one embodiment, the pellets are compressed to 5% or more of their volume. Volume refers to the volume occupied by the pellets and surrounding air in the cylinder, which can typically be easily determined by syringe markings. In one embodiment, the pellets are compressed to at least 10%, 15%, 20%, 25%, 30%, 35%, or 40% of their volume. In another embodiment, the pellets are compressed to up to 70%, 60%, or 50% of their volume. In one embodiment, the pellets are compressed to 40% to 60% of their volume. The use of pellets, compared to a monolithic sponge, allows for more uniform compression of the entire volume of the tissue repair material.

[0051] In one embodiment, the tissue repair material in the tube has a density of at least 100 kg / m³ before hydration. 3 150kg / m 3 200kg / m 3 Or 250kg / m 3 In one implementation, the density of the tissue repair material in the tube before hydration is at most 400 kg / m³. 3 350kg / m 3 325kg / m 3 Or 300kg / m 3 In one implementation, the tissue repair material in the tube has a prior density of 250 kg / m³. 3 Up to 300kg / m 3 In one implementation, 3g to 4.5g of tissue repair material yields approximately 9cc of extrudable tissue repair material. In another implementation, 2g to 4g of tissue repair material yields approximately 6cc of extrudable tissue repair material.

[0052] In one embodiment, a first quantity of pellets is inserted into the cylinder and compressed. Subsequently, a second quantity of pellets is inserted over the previously compressed first quantity and compressed. A third or more quantities may also be inserted and compressed.

[0053] In one embodiment, the compressive force is removed after compression of the pellets and before hydration. In one embodiment, after the compressive force is removed, the tissue repair material will substantially retain its compressed volume. In one embodiment, after the compressive force is removed, the tissue repair material expands by 10% or less relative to its compressed volume.

[0054] In one implementation, compression is present during hydration. In such an implementation, the obstruction can be removed, for example, by a tamping machine, thus allowing removal of the obstruction while maintaining compression. The hydration fluid can then be dispensed into the channels, after which tissue repair material is mixed with the hydration fluid.

[0055] Once the obstruction is removed, a channel is formed, defined by a portion of the inner wall of the cylinder and the tissue repair material. In one embodiment, the tissue repair material in its dry state is sufficiently flow-resistant such that the channel maintains a substantially uniform volume after the obstruction is removed. This allows for the transport of the tissue repair device in the absence of obstruction within the cylinder. In another embodiment, the compressed pellets remain substantially stationary after the obstruction is removed and the compression force is applied.

[0056] The pellets typically do not completely fill the space around the blockage, thus allowing a larger amount of channel defined by the inner surface of the barrel than would be possible assuming the tissue repair material is a material with very low viscosity. Therefore, the channel is partially defined by the inner surface of the barrel and the compressed tissue repair material. This is in Figure 2 The description in the middle, Figure 2 This is a top view of syringe 1 after the tissue repair material pellets have been inserted into the cartridge and the tissue repair material has been compressed. The tissue repair material 10 flows slightly around the obstructions 6 and 7. After removing the obstructions, two channels remain, as shown... Figure 3 As shown. Channels 11 and 12 are defined by compressed tissue repair material 10 and inner wall 5.

[0057] In one embodiment, the hydration fluid includes a sterile fluid, saline, whole blood, blood components (e.g., platelet-rich plasma), or bone marrow aspirate. The channels described herein allow the hydration fluid to flow more easily to the tissue repair material closest to the tip, compared to dispensing into a channel entirely defined by the tissue repair material. Preferably, the hydration fluid and tissue repair material do not need to be mixed to form sufficient extrudable tissue repair material. Typically, a residence time of 30 to 60 seconds after hydration is sufficient to form extrudable tissue repair material. Optionally, the hydration fluid and tissue repair material are mixed. After hydration, the extrudable tissue repair material can be extruded from the syringe by, for example, actuating a plunger located in the barrel.

[0058] In one embodiment, the tissue repair device is a bone void filler or is suitable for filling defects in bone. In another embodiment, the tissue repair device produces a flowable solution, gel, paste, or putty that can be extruded from a tip under manually applied compressive force via a plunger.

[0059] Example

[0060] Manufacturing of tissue repair material pellets

[0061] An aqueous slurry comprising natural insoluble collagen fibers with an average fiber length of approximately 5 mm, soluble collagen, and minerals with a particle size of approximately 90-600 μm is manufactured. The slurry has a solid content of approximately 3.8-4.2% by weight. The slurry is spread into a triangular prism-shaped mold with rounded edges. The base of the prism is approximately 5 mm, the height is approximately 5 mm, and the depth is approximately 4 mm. The mold tray is placed in a freeze dryer and freeze-dried. Subsequently, pellets of tissue repair material are obtained by separating the freeze-dried slurry from the mold.

[0062] Manufacturing of tissue repair devices containing pellets

[0063] OsteoPrecision from Nordson Medical is available in 15cc capacity. TM Bone graft delivery device. The tip of the delivery device is separate from the barrel. One or more suitable plugs are added in the form of a rod with a diameter of 2.4 mm and a height of approximately 96 mm. The rod contacts the inner wall of the barrel. Unless otherwise specified, two rods are used, placed opposite each other. The volume of the syringe including the two rods is approximately 13.8 cc. The configuration is approximately as follows: Figure 2 As shown.

[0064] For the 9cc device, the plunger is positioned such that the cylinder volume is 15cc. A pellet of tissue repair material, prepared as described above, is placed into the cylinder. The pellet is manually compressed to approximately 50% of its original volume using a lever. Next, another 1.9g pellet is added on top of the compressed pellet, and the pellet is compressed again. At this point, the cylinder is filled with a combination of compressed tissue repair material and blockage. The blockage is removed, and then the tip of the delivery device is secured to the cylinder. The density of the tissue repair material in the cylinder before hydration is approximately 275 kg / m³. 3 .

[0065] Tissue repair device performance evaluation

[0066] Adequacy of hydration is assessed by visually confirming that all pellets in the syringe are hydrated and surrounded by fluid. Additionally, the cohesiveness of the extruded material is evaluated. If the pellets are adequately hydrated, the extruded material will exit the syringe as a clean, thread-like stream; if insufficiently hydrated, cavities of dry pellets will be visible in the extrudate. Furthermore, after fully manually pressing the plunger, adequately hydrated material will not leave dry pellets inside the syringe body.

[0067] Injection force is typically measured by whether an extrudable material can be fully injected manually without excessive force, rather than requiring excessive force or leaving a large amount of material in the syringe. Instron syringes can also be used to assess injection force by positioning the syringe such that the force required to inject the material is measured. If it can be injected with 21 pounds (93.4 N) or less (equivalent to the average adult's hand strength), the material is suitable for manual injection.

[0068] Example 1—Formation of Tissue Repair Materials

[0069] The first tissue repair device is formed as described in the section on the manufacture of tissue repair devices containing pellets.

[0070] A second tissue repair device is similarly formed. However, instead of the pellets described, four disc-shaped sponges, approximately 8 mm high and 10 mm in radius, are placed in a cylinder excluding the rods and compressed. The stacked sponges are not as compressible as the pellets, thus producing a tissue repair material with a density of 192 kg / m³ before hydration. 3 Tissue repair materials.

[0071] Attach the hydration syringe to the tip of each of the first and second tissue repair devices and actuate the syringe. Dispense approximately 9 cc of hydration fluid into the cartridge. Allow 60 seconds before extruding the extrudable tissue repair material.

[0072] The first tissue repair device containing pellets was found to outperform the second tissue repair device in terms of both hydration adequacy of the tissue repair material and injection force.

[0073] Example 2 – Channel Formation Method

[0074] The first tissue repair device is manufactured as described previously in the section on the manufacture of tissue repair devices containing pellets, but without any obstructions.

[0075] The second tissue repair device is manufactured as described above, but without obstructions. After loading and compressing the tissue repair material, a rod is forced against the inner wall of the cylinder towards the plunger and through the tissue repair material to form a channel.

[0076] The third tissue repair device is manufactured as previously described, but without obstructions. After loading and compressing the tissue repair material, two rods are forced against the inner wall of the cylinder towards the plunger and through the tissue repair material to form two channels.

[0077] The fourth tissue repair device shall be manufactured as previously described in the section on the manufacture of tissue repair devices containing pellets.

[0078] Attach the hydration syringe to the tip of each tissue repair device in the tissue repair kit and actuate the hydration syringe. Dispense approximately 9 cc of hydration fluid into the cartridge. Allow 60 seconds before extruding the extrudable tissue repair material.

[0079] The second (one-bar) and third (two-bar) tissue repair devices were found to outperform the first (barless) tissue repair device. However, the fourth tissue repair device showed the best performance in terms of hydration adequacy and injection force, and was easier to assemble than the second and third tissue repair devices.

[0080] Example 3 – Transmission Stability

[0081] To test the dimensional stability of the fabricated tissue repair device, the previously formed repair device was placed on a New Brunswick Incubator Shaker Model Innova 44R. The settings were: 45 RPM at 25°C. After 2 hours, no visible dimensional change was observed in the channels. After an additional 24 hours, no visible dimensional change remained, indicating that the formed tissue repair device may be capable of delivery for commercial use without obstructions in place.

[0082] Example 4 – Changes in Channel Position and Volume

[0083] The tissue repair device prototype was fabricated as described above, but the number and diameter of the rods were varied to change the channel volume and size. Proofread the prototypes in triplicate according to the table below:

[0084] sample rod Diameter of each rod (mm) 1 1 1.2 2 1 2.4 3 1 4.8 4 2 1.2 5 2 2.4 6 2 4.8 7 3 1.2 8 3 2.4 9 3 4.8 10 4 1.2 11 4 2.4 12 4 4.8 CE 1 0 not applicable

[0085] The channels are equidistantly spaced, and the rod is positioned to contact the inner wall of the tube. Optimal samples will allow for the maximum amount of tissue repair material while simultaneously generating sufficient hydration and appropriate injection force.

[0086] Place approximately 1.9-2g of pellets into the cartridge and compress it. Then, place another 1.9-2g of pellets into the cartridge and compress it again. Secure the tip of the syringe to the cartridge. Then, attach a syringe containing saline solution to the tip and hydrate the tissue repair material at a ratio of 2.25g water to 1g pellets.

[0087] The hydration adequacy and injection force of the extrudable tissue repair material were assessed. Suitable results were expected using at least one rod compared to the comparative example. However, two rods were expected to perform better than one rod, and the performance of two rods was similar to that of three or four rods. A 2.4 mm diameter rod was also expected to perform better than 1.2 mm and 4.8 mm rods.

[0088] Additional description of exemplary implementation schemes

[0089] 1. A method for forming a tissue repair device, the method comprising the following steps:

[0090] a. Providing an syringe, the syringe including a barrel configured or configurable to be in fluid communication with a tip, the barrel including an inner wall and at least one elongated obstruction extending along the length of the barrel, the obstruction contacting or proximating the inner wall;

[0091] b. Inserting multiple porous, compressible tissue repair material pellets into the cylinder, the tissue repair material being extruded through the tip upon hydration; and

[0092] c. Remove the obstruction.

[0093] 2. A method for forming a tissue repair device, the method comprising the following steps:

[0094] a. A syringe comprising a barrel and a tip, the barrel including an inner wall, the tip being separable from and securely fastened to the barrel such that the tip is in fluid communication with the barrel;

[0095] b. Place the obstruction into the cylinder, wherein the obstruction contacts or is close to the inner wall of the cylinder;

[0096] c. Insert a first quantity of porous, compressible tissue repair material pellets into the cylinder;

[0097] d. Compress the tissue repair material;

[0098] e. Optionally, inserting a second quantity of porous, compressible tissue repair material pellets into the cylinder, and compressing the second quantity of tissue repair material; and

[0099] f. Remove the obstruction to form a channel defined by the inner wall of the tube and the tissue repair material.

[0100] 3. The method according to any one of the foregoing exemplary embodiments, the method further includes the step of: fastening the tip to the cylinder such that the cylinder is in fluid communication with the tip.

[0101] 4. The method according to any one of the foregoing exemplary embodiments, the method further comprising the step of compressing at least some of the plurality of pellets.

[0102] 5. The method according to any one of the foregoing exemplary embodiments, the method further comprising the step of compressing at least some of the plurality of pellets before removing the obstruction.

[0103] 6. The method according to any one of the foregoing exemplary embodiments, the method comprising inserting a first amount of pellets into the cylinder, compressing the first amount of pellets, inserting a second amount of pellets into the cylinder, and compressing the second amount of pellets.

[0104] 7. The method according to any one of the foregoing exemplary embodiments, wherein the obstruction is removed by advancing the obstruction from the cylinder toward the proximal side.

[0105] 8. The method according to any one of the foregoing exemplary embodiments, the method further comprising the step of hydrating the tissue repair material by inserting a hydration fluid into the channel.

[0106] 9. The method according to any one of the foregoing exemplary embodiments, the method further comprising the steps of inserting a hydration fluid into the channel and mixing the hydration fluid with the tissue repair material.

[0107] 10. A method for treating tissue defects in a human or animal, the method comprising the following steps:

[0108] a. Providing an syringe comprising a barrel in fluid communication with a tip, the barrel including an inner wall, a tissue repair material, and at least one elongated channel extending along the length of the barrel, the channel being defined by the inner wall and the tissue repair material, wherein the tissue repair material is porous and compressible;

[0109] b. Insert the hydrated fluid into the channel to form an extrudable tissue repair material.

[0110] 11. A method for treating tissue defects in a human or animal, the method comprising the following steps:

[0111] a. Providing an syringe comprising a barrel in fluid communication with a tip, the barrel including an inner wall, a tissue repair material, and at least one elongated channel extending along the length of the barrel, the channel being defined by the inner wall and the tissue repair material, wherein the tissue repair material is porous and compressible;

[0112] b. Attach a second syringe to the tip, the second syringe containing an hydrated fluid;

[0113] c. Actuate the second syringe to inject the hydrated fluid into the barrel of the syringe;

[0114] d. Wait until the tissue repair material is fully hydrated to form an extrudable tissue repair material; and

[0115] e. Extruding the extrudable tissue repair material into a tissue defect in a human or animal body.

[0116] 12. The method according to any one of the foregoing exemplary embodiments, wherein the hydrated fluid is inserted into the cylinder via the tip.

[0117] 13. The method according to any one of the foregoing exemplary embodiments, wherein the hydrated fluid is inserted into the cylinder by attaching a second syringe containing the hydrated fluid to the tip and dispensing the hydrated fluid from the second syringe.

[0118] 14. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the method or apparatus further comprises a second, third, fourth, fifth, sixth, seventh, eighth, ninth, or tenth obstruction.

[0119] 15. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the obstruction is in the form of a cylinder.

[0120] 16. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the blockage is in the form of a cylinder with a diameter of at least 0.5 mm, 1 mm, 1.5 mm or 2 mm.

[0121] 17. The method or apparatus according to any of the foregoing exemplary embodiments, wherein the obstruction is in the form of a cylinder with a diameter of up to 10 mm, 9 mm, 8 mm, 7 mm, 6 mm, 5 mm, 4 mm or 3 mm.

[0122] 18. The method or apparatus according to any one of the foregoing exemplary embodiments, the method or apparatus further comprising second, third, fourth, fifth, sixth, seventh, eighth, ninth and / or tenth obstructions, wherein each obstruction contacts the inner wall of the cylinder.

[0123] 19. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the method or apparatus further comprises a second, third, fourth, fifth, sixth, seventh, eighth, ninth and / or tenth channel.

[0124] 20. The method or apparatus according to any one of the foregoing exemplary embodiments, the method or apparatus further comprising second, third, fourth, fifth, sixth, seventh, eighth, ninth and / or tenth channels, wherein each channel is defined by the inner wall and the tissue repair material.

[0125] 21. The method according to any one of the foregoing exemplary embodiments, the method further comprising the step of mixing the tissue repair material and the hydration fluid.

[0126] 22. The method according to any one of the foregoing exemplary embodiments, the method further comprising the step of inserting the extrudable tissue repair device into a tissue defect in a human or animal body.

[0127] 23. The method according to any one of the foregoing exemplary embodiments, the method further comprising the step of injecting the extrudable tissue repair device into a tissue defect in a human or animal body.

[0128] 24. A tissue repair device comprising: a syringe including a barrel in fluid communication with a tip, the barrel including an inner wall and a compressed porous tissue repair material present in the barrel, wherein the tissue repair device is configured such that at least one elongated channel extends along the length of the barrel through the tissue repair material, wherein the channel is defined by the inner wall and the tissue repair material.

[0129] 25. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair material comprises polymer fibers.

[0130] 26. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair material comprises a sponge based on a natural polymer.

[0131] 27. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the sponge is a collagen-based sponge.

[0132] 28. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair material comprises natural polymer fibers.

[0133] 29. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair material further comprises acid-soluble collagen.

[0134] 30. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair material comprises acid-soluble collagen and collagen fibers.

[0135] 31. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair material further comprises minerals.

[0136] 32. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair material further comprises minerals, and the minerals are present as particles with an average particle size of 0.05 mm to 5 mm, or 0.05 mm to 2 mm.

[0137] 33. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the mineral exists as particles with an average particle size of at least 0.05 mm, at least 0.1 mm, at least 0.2 mm, at least 0.3 mm, at least 0.4 mm, or at least 0.5 mm.

[0138] 34. The method or apparatus according to any of the foregoing exemplary embodiments, wherein the mineral is present as particles with an average particle size of at most 5 mm, at most 4 mm, at most 3 mm, at most 2 mm, at most 1 mm or at most 0.5 mm.

[0139] 35. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair material comprises 50% to 95% by weight of minerals and 5% to 50% by weight of collagen, respectively, based on the total weight of the solids of the dried sponge or the slurry.

[0140] 36. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair material comprises 5 wt%, 6 wt%, 7 wt%, 8 wt%, 9 wt%, 10 wt%, 11 wt%, 12 wt%, 13 wt%, 14 wt%, or 15 wt% to 30 wt%, 29 wt%, 28 wt%, 27 wt%, 26 wt%, 25 wt%, 24 wt%, 23 wt%, 22 wt%, 21 wt%, 20 wt%, 19 wt%, 18 wt%, 17 wt%, or 16 wt% collagen, respectively, based on the total weight of the solids of the dried sponge or the slurry.

[0141] 37. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair material comprises 65 wt%, 66 wt%, 67 wt%, 68 wt%, 69 wt%, 70 wt%, 71 wt%, 72 wt%, 73 wt%, 74 wt%, 75 wt%, 76 wt%, 77 wt%, 78 wt%, 79 wt%, or 80 wt% to 95 wt%, 94 wt%, 93 wt%, 92 wt%, 91 wt%, 90 wt%, 89 wt%, 88 wt%, 87 wt%, 86 wt%, or 85 wt% minerals, respectively, based on the total weight of the solids of the dried sponge or the slurry.

[0142] 38. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair material comprises 10% to 75% by weight of acid-soluble collagen and 25% to 90% by weight of collagen fibers, respectively, based on the total amount of collagen in the dried sponge or slurry.

[0143] 39. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the weight ratio of collagen fibers to acid-soluble collagen in the tissue repair material is 25:75 to 75:25.

[0144] 40. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair material is cross-linked.

[0145] 41. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair material is formed by freeze-drying a slurry containing collagen and water.

[0146] 42. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair material is formed by freeze-drying a slurry comprising acid-soluble collagen, collagen fibers and water.

[0147] 43. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair material is formed by freeze-drying a slurry comprising acid-soluble collagen, collagen fibers, mineral particles and water.

[0148] 44. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair material comprising acid-soluble collagen is processed without the use of enzymes.

[0149] 45. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair material comprises collagen fibers that are natural collagen fibers.

[0150] 46. ​​The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair material comprises polymer fibers with an average length of 1 mm to 15 mm.

[0151] 47. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair material comprises polymer fibers with an average length of 0.5 mm to 10 mm.

[0152] 48. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair material comprises polymer fibers with an average length of 1 mm to 5 mm.

[0153] 49. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair material comprises polymer fibers having an average length of at least 0.5 mm, at least 1 mm, at least 2 mm, at least 3 mm, or at least 4 mm.

[0154] 50. The method or apparatus according to any of the foregoing exemplary embodiments, wherein the tissue repair material comprises polymer fibers with an average length of up to 15 mm, up to 12 mm, up to 10 mm, up to 9 mm, up to 8 mm, up to 7 mm, up to 6 mm, up to 5 mm, or up to 4 mm.

[0155] 51. The method according to any one of the foregoing exemplary embodiments, the method further comprising the step of forming pellets of tissue repair material.

[0156] 52. The method according to any one of the foregoing exemplary embodiments, the method further comprising the step of forming pellets of tissue repair material by freeze-drying an aqueous slurry in a mold having a pellet shape.

[0157] 53. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the pellets are formed by freeze-drying an aqueous slurry in a mold having a pellet shape.

[0158] 54. The method according to any one of the foregoing exemplary embodiments, the method further comprising the step of forming pellets of tissue repair material by cutting a sponge containing polymer fibers.

[0159] 55. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the pellets comprise the shape of a triangular prism, a rectangular prism, other polygonal prisms, or a cylinder.

[0160] 56. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the majority of the pellets have a volume of 250 mm². 3 200mm 3 150mm 3 125mm 3 100mm 3 75mm 3 50mm 3 or 40mm 3 Or smaller.

[0161] 57. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the majority of the pellets have a volume of 25 mm. 3 30mm 3 35mm 3 40mm3 45mm 3 50mm 3 Or 75mm 3 Or larger.

[0162] 58. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the majority of the plurality of pellets has a volume of 30 mm. 3 Up to 50mm 3 .

[0163] 59. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the plurality of pellets are sized such that the pellets will pass through the tip.

[0164] 60. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the maximum size of the pellet is 6 mm or less, 5 mm or less, or 4 mm or less.

[0165] 61. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the maximum size of the pellet is smaller than the inner diameter of the tip.

[0166] 62. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the volume of the cylinder is at least 1 cubic centimeter, 3 cubic centimeters, 5 cubic centimeters, 6 cubic centimeters, 7 cubic centimeters, 8 cubic centimeters, 9 cubic centimeters, 10 cubic centimeters, 11 cubic centimeters, 12 cubic centimeters, 13 cubic centimeters, 14 cubic centimeters, or 15 cubic centimeters.

[0167] 63. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the volume of the cylinder is at most 25 cubic centimeters, 20 cubic centimeters, 18 cubic centimeters, 17 cubic centimeters, 16 cubic centimeters or 15 cubic centimeters.

[0168] 64. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the maximum volume of the syringe is 1 cubic centimeter to 15 cubic centimeters.

[0169] 65. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the pellets are compressed to at least 10 vol%, 15 vol%, 20 vol%, 25 vol%, 30 vol%, 35 vol%, or 40 vol%.

[0170] 66. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the pellets are compressed to a maximum of 70% by volume, 60% by volume, or 50% by volume.

[0171] 67. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the pellets are compressed by 40% to 60% by volume.

[0172] 68. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the channel occupies 1% to 10% of the total filling volume of the cylinder.

[0173] 69. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the channel occupies at least 1%, 1.5%, or 2% of the total filling volume of the cylinder.

[0174] 70. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the channel accounts for at most 10%, 9%, 8%, 7%, 6%, 5%, or 4% of the total filling volume of the cylinder.

[0175] 71. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the channel occupies 1.5% to 4% of the total filling volume of the cylinder.

[0176] 72. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair material in the cylinder has a density of 250 kg / m³ before hydration. 3 Up to 300kg / m 3 .

[0177] 73. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair material in the cylinder has a density of at least 100 kg / m³ before hydration. 3 150kg / m 3 200kg / m 3 Or 250kg / m 3 .

[0178] 74. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the density of the tissue repair material in the cylinder before hydration is at most 400 kg / m³. 3 350kg / m 3 325kg / m 3 Or 300kg / m 3 .

[0179] 75. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein 3g to 4.5g of the tissue repair material produces about 9cc of the extrudable tissue repair material.

[0180] 76. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein 2g to 4g of the tissue repair material produces about 6cc of the extrudable tissue repair material.

[0181] 77. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair material or the hydration fluid further comprises a bioactive agent.

[0182] 78. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair material or the hydration fluid further comprises bone morphogenetic proteins, demineralized bone matrix, growth factors or stem cells.

[0183] 79. A tissue repair apparatus, formed according to the method of any one of the foregoing exemplary embodiments.

[0184] 80. A bone void filler, formed according to the method of any one of the foregoing exemplary embodiments.

[0185] 81. A flowable solution, gel, paste, or putty, capable of being extruded and formed according to any one of the foregoing exemplary embodiments.

[0186] 82. The method or apparatus according to any one of the foregoing exemplary embodiments, wherein the tissue repair device or the tissue repair material is a bone void filler or is suitable for filling defects in bone.

[0187] Unless otherwise specified herein or obviously contradicted by the context, the use of the terms “a,” “an,” and “the,” and similar indicative words, in the context of describing the invention (especially in the context of the following claims), should be interpreted as covering both the singular and plural. Unless otherwise stated, the terms “comprising,” “having,” “including,” and “containing” should be interpreted as open-ended terms (i.e., meaning “including but not limited to”). Unless otherwise indicated herein, the description of value ranges herein is intended only as a shorthand method of referring to each individual value falling within that range, and each individual value is incorporated into this specification as if it were individually referenced herein. Unless otherwise claimed, the use of any and all examples or illustrative language (e.g., “for example”) provided herein is intended only to better illustrate the invention and not to limit the scope of the invention. No language in the specification should be construed as indicating that any unclaimed element is essential to the practice of the invention.

[0188] This document describes preferred embodiments of the invention, including the best mode known to the inventors for carrying out the invention. Variations of those preferred embodiments will be apparent to those skilled in the art after reading the foregoing description. The inventors intend that those skilled in the art appropriately employ such variations, and that the inventors intend to practice the invention in ways other than those specifically described herein. Therefore, the invention includes all modifications and equivalents of the subject matter described in the appended claims as permitted by applicable law. Although certain optional features are described as embodiments of the invention, this description is intended to include and specifically disclose all combinations of these embodiments unless otherwise expressly indicated or physically impossible.

Claims

1. A method for forming a tissue repair device, the method comprising the following steps: a. Providing an syringe, the syringe including a barrel configured to be in fluid communication with a tip, the barrel including an inner wall, a tissue repair material, and at least one elongated channel extending along the length of the barrel, the channel being defined by the inner wall and the tissue repair material, wherein the tissue repair material comprises porous, compressible pellets, and the tissue repair material is porous and compressible; as well as b. Insert the hydrated fluid into the channel to form an extrudable tissue repair material.

2. The method according to the preceding claim, wherein, The hydrated fluid is inserted into the cylinder by attaching a second syringe containing the hydrated fluid to the tip of the cylinder, which is in fluid communication with the cylinder, and dispensing the hydrated fluid from the second syringe into the cylinder via the tip.

3. The method according to claim 1 or 2, the method further comprising a second channel positioned relative to the channel, wherein the second channel is defined by the inner wall of the cylinder and the tissue repair material.

4. The method according to claim 1, further comprising the step of injecting the extrudable tissue repair device into a tissue defect in a human or animal body.

5. The method according to claim 3, further comprising the step of injecting the extrudable tissue repair device into a tissue defect in a human or animal body.

6. The method according to claim 1, wherein the tissue repair material comprises polymer fibers.

7. The method of claim 3, wherein the tissue repair material comprises polymer fibers.

8. The method of claim 1, wherein the tissue repair material comprises a freeze-dried sponge containing collagen fibers and mineral particles.

9. The method of claim 8, wherein the average particle size of the mineral particles is from 0.05 mm to 1 mm.

10. The method according to claim 8 or 9, wherein, Based on the total weight of the freeze-dried sponge, the tissue repair material comprises 50% to 95% by weight of mineral particles and 5% to 50% by weight of collagen.

11. The method according to claim 1 or 8, wherein the tissue repair material comprises polymer fibers with an average length of 1 mm to 5 mm.

12. The method according to claim 1 or 8, wherein the pellet comprises the shape of a triangular prism, a rectangular prism, other polygonal prisms, or a cylinder.

13. The method according to claim 1 or 8, wherein the maximum size of the pellet is smaller than the inner diameter of the tip.

14. The method according to claim 1 or 8, wherein the pellets are compressed by 40% to 60% by volume.

15. The method according to claim 1 or 8, wherein the channel occupies 1.5% to 4% of the total filling volume of the cylinder.

16. A flowable solution, gel, paste, or putty, capable of being extruded and formed by the method according to any one of claims 1-15.

17. A tissue repair device, the tissue repair device comprising: A syringe comprising a barrel in fluid communication with a tip, the barrel including an inner wall and a tissue repair material present within the barrel, wherein the tissue repair material comprises porous, compressible pellets, and the tissue repair material is porous and compressible. The tissue repair device includes at least one elongated channel that extends along the length of the cylinder through the tissue repair material. The channel is defined by the inner wall and the tissue repair material, and The tissue repair material mentioned above includes collagen fibers and mineral particles.

18. The tissue repair apparatus of claim 17, wherein the channel occupies 1% to 10% of the total filling volume of the cylinder.

19. The tissue repair apparatus according to claim 17 or 18, wherein the density of the tissue repair material in the cylinder is 250 kg / m³. 3 Up to 300 kg / m 3 .

20. The tissue repair device according to claim 17 or 18, wherein the maximum volume of the syringe is from 1 cubic centimeter to 15 cubic centimeters.

21. The tissue repair device according to claim 17 or 18, wherein the maximum size of the pellet is 6 mm or less.

22. The tissue repair device according to claim 17 or 18, wherein the average particle size of the mineral particles is from 0.05 mm to 2 mm.

23. The tissue repair device according to claim 17 or 18, wherein the tissue repair device has two elongated channels.

24. The tissue repair apparatus according to claim 17 or 18, wherein the diameter of the channel is 2 mm to 5 mm.

25. A method of forming the tissue repair device of claim 17 or 18, the method comprising the following steps: a. Providing an syringe, the syringe including a barrel configured to be in fluid communication with a tip, the barrel including an inner wall and at least one elongated obstruction extending along the length of the barrel, the obstruction contacting or proximating the inner wall; b. Inserting multiple porous, compressible tissue repair material pellets into the cylinder, wherein the tissue repair material can be extruded through the tip when hydrated; as well as c. Remove the obstruction.

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