Implant device and method for making the implant device

Abstract

Disclosed is an implant device that may be configured to repair tissue. The implant device may have a distal end that may be configured to be connectable to at least a first portion of tissue. The implant device may have a proximal end that may be configured to be connectable to at least a second portion of tissue. The implant device may have a substrate that may be configured to form an interface between the first and second portions of tissue. The implant device may have a longitudinal axis extending within the substrate between the distal and proximal ends. The implant device may have at least one suture at least partially preloaded within at least one preformed channel. The at least one preformed channel may be formed during and / or proximal to the formation of the implant device.

Description

[Background technology]

[0001] [Citation to Related Applications] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 217,197, filed June 30, 2021, which is incorporated by reference in its entirety.

[0002] Soft tissues, tendons, and / or ligaments may be injured during sports activities, strenuous exercise, physically demanding work, and / or normal, everyday physical activities. However, this injury is inevitable, and patients who have suffered such injuries may be restricted, perhaps significantly, from employment functioning, sports activities, physical activity participation, and / or some social involvement.

[0003] Patients with such injuries may typically seek surgical intervention to repair such damage. While soft tissues, tendons, and / or ligaments, particularly the anterior cruciate ligament (ACL), medial collateral ligament (MCL), Achilles tendon, and meniscus, may heal adequately and / or completely on their own, this may not be the case. For example, if a natural clot / scaffold develops at all, the clot / scaffold may not develop in a timely or structurally appropriate manner.

[0004] Tissues found outside of joints heal by forming fibrin clots that connect broken tissue ends together and then remodel to form scars that heal the tissue. Inside the synovial joint, fibrin clots either fail to form or dissolve quickly after knee joint trauma, thus preventing joint degeneration and stiffness after minor trauma. Joints contain synovial fluid that naturally prevents clot formation within the joint as part of normal joint activity. This fibrinogen degradation process results in premature loss of the fibrin clot scaffold and disruption of the healing process for tissues within the joint or intra-articular tissue. Surgical procedures to repair such trauma / injuries may involve removing the damaged tissue and replacing it with a point-to-point tissue graft. Summary of the Invention

[0005] Disclosed is an implant device that may be configured to repair tissue. The implant device may have a distal end that may be configured to be connectable to at least a first portion of tissue. The implant device may have a proximal end that may be configured to be connectable to at least a second portion of tissue. The implant device may have a substrate that may be configured to form an interface between the first and second portions of tissue. The implant device may have a longitudinal axis extending within the substrate between the distal and proximal ends. The implant device may have at least one preformed channel disposed within the substrate. The implant device may have at least one suture that may be at least partially preloaded within the at least one channel.

[0006] In one or more scenarios, the implant device may be configured (at least partially and / or substantially) such that the tissue is at least one of a soft tissue, a tendon, or a ligament.

[0007] In one or more scenarios, the substrate may be composed (eg, at least partially and / or substantially) of collagen (eg, human, porcine, bovine, equine, avian, fish, etc.) and / or bovine connective tissue.

[0008] In one or more scenarios, the implant device may be (e.g., at least partially and / or substantially) cylindrical, (e.g., at least partially and / or substantially) oval, (e.g., at least partially and / or substantially) round, (e.g., at least partially and / or substantially) rectangular, (e.g., at least partially and / or substantially) square, or (e.g., at least partially and / or substantially) trapezoidal, among other shapes.

[0009] In one or more scenarios, the substrate may be made of one or more substances that are saturable by human blood.

[0010] In one or more scenarios, the at least one pre-formed channel may be formed during formation of the implant device and / or at a point (eg, substantially) close in time to post-forming of the implant device.

[0011] In one or more scenarios, at least one suture may be a number 2 absorbable suture or a number 2 non-absorbable suture.

[0012] In one or more scenarios, the at least one preformed channel can be disposed along a center longitudinal axis of the implant device. In one or more scenarios, the at least one preformed channel can have a first opening disposed in the substrate. The implant device can have a second opening disposed in the substrate. The first opening and / or the second opening can be configured to permit passage of at least one suture through the at least one preformed channel.

[0013] In one or more scenarios, the first opening can be (e.g., at least partially and / or substantially) centered on a proximal end of the implant device, and the second opening can be (e.g., at least partially and / or substantially) centered on a distal end of the implant device.

[0014] In one or more scenarios, the at least one preformed channel can be a first preformed channel, and the implant device can have one or more of a second preformed channel, a third preformed channel, and / or a fourth preformed channel.

[0015] In one or more scenarios, the first preform channel can have a first opening in the substrate and / or a second opening in the substrate. The second preform channel can have a third opening in the substrate and / or a fourth opening in the substrate. The third preform channel can have a fifth opening in the substrate and / or a sixth opening in the substrate. The fourth preform channel can have a seventh opening in the substrate and / or an eighth opening in the substrate.

[0016] In one or more scenarios, the at least one preloaded suture can be a first preloaded suture. The implant device can have a second suture at least partially preloaded in a second preformed channel. The implant device can have a third suture at least partially preloaded in a third preformed channel. The implant device can have a fourth suture at least partially preloaded in a fourth preformed channel.

[0017] In one or more scenarios, the first opening and / or the second opening can be configured to at least allow passage of a first suture through the first preform channel, the third opening and / or the fourth opening can be configured to at least allow passage of a second suture through the second preform channel, the fifth opening and / or the sixth opening can be configured to at least allow passage of a third suture through the third preform channel, and the seventh opening and / or the eighth opening can be configured to at least allow passage of a fourth suture through the fourth preform channel.

[0018] In one or more scenarios, the first opening of the substrate can be disposed in a first quadrant of the proximal end at a through angle ranging from 0° to 45° relative to the longitudinal axis. The second opening of the substrate can be disposed in a first quadrant of the distal end at a through angle ranging from 0° to 45° relative to the longitudinal axis. The third opening of the substrate can be disposed in a second quadrant of the proximal end at a through angle ranging from 0° to 45° relative to the longitudinal axis. The fourth opening of the substrate can be disposed in a second quadrant of the distal end at a through angle ranging from 0° to 45° relative to the longitudinal axis.

[0019] In one or more scenarios, the fifth opening of the substrate can be disposed in a third quadrant of the proximal end at a through angle ranging from 0° to 45° relative to the longitudinal axis. The sixth opening of the substrate can be disposed in a third quadrant of the distal end at a through angle ranging from 0° to 45° relative to the longitudinal axis. The seventh opening of the substrate can be disposed in a fourth quadrant of the proximal end at a through angle ranging from 0° to 45° relative to the longitudinal axis. The eighth opening of the substrate can be disposed in a fourth quadrant of the distal end at a through angle ranging from 0° to 45° relative to the longitudinal axis.

[0020] In one or more scenarios, the first preformed channel, the second preformed channel, the third preformed channel, and / or the fourth preformed channel may have a trajectory within the substrate that may be (e.g., at least partially and / or substantially) straight, (e.g., at least partially and / or substantially) diagonal, and / or (e.g., at least partially and / or substantially) spiral.

[0021] In one or more scenarios, the first opening of the substrate can be disposed in the first half of the proximal end at a through angle ranging from 0° to 45° relative to the longitudinal axis. The second opening of the substrate can be disposed in the first half of the distal end at a through angle ranging from 0° to 45° relative to the longitudinal axis. The third opening of the substrate can be disposed in the second half of the proximal end at a through angle ranging from 0° to 45° relative to the longitudinal axis. The fourth opening of the substrate can be disposed in the second half of the distal end at a through angle ranging from 0° to 45° relative to the longitudinal axis.

[0022] In one or more scenarios, implant devices with a different number of preformed channels than those shown may be derived from the description herein and are within the scope of the present invention. For example, implant devices with 3, 5, 6, 7, and / or 8 preformed channels are readily understood to be within the scope of the description herein. In one or more scenarios, a target number of preformed channels divisible by 2 may be useful. In one or more scenarios, the size of the implant device and / or the size / number of sutures may inform the target number of preformed channels, for example.

[0023] In one or more scenarios, implant devices with a different number of preloaded sutures than those shown may be derived from the description herein and are within the scope of the present invention. For example, implant devices with fewer or more preloaded sutures than the number of preformed channels are readily understood to be within the scope of the description herein. In one or more scenarios, a target number of preloaded sutures providing at least one preloaded suture per preformed channel may be useful. In one or more scenarios, the size of the implant device and / or the size / number of sutures may inform, for example, the target number of preloaded sutures and / or the target number of preloaded sutures per preformed channel.

[0024] An implant device for repairing tissue can be made using one or more methods. The one or more methods may include providing a mold (e.g., injection molding). The mold may have an interior space. The one or more methods may include placing one or more needle elements within the interior space. The needle elements (e.g., each) may have a first end that extends outside the interior space. The one or more methods may include injecting / adding a substrate forming material into the interior space. The one or more needle elements may provide one or more negative molding cavities within the interior space. The one or more methods may include removing the formed substrate from the injection mold. The one or more methods may include processing the formed substrate to form the implant device. The one or more negative molding cavities may provide one or more preformed channels within the implant device. The one or more preformed channels may be configured to allow for the passage of one or more sutures through the one or more preformed channels.

[0025] The one or more methods may include attaching one or more sutures to a first end of one or more needle elements. In the one or more methods, removing the formed substrate from the injection mold may include withdrawing one or more sutures from one or more preformed channels. The one or more withdrawn sutures may provide the implant device with one or more preloaded sutures.

[0026] The one or more methods of making the implant device may include providing a mold (e.g., injection molding). The mold may have an interior space. The one or more methods may include injecting / adding a substrate-forming material into the interior space. The one or more methods may include inserting one or more needle-like elements into the substrate-forming material. The one or more needle-like elements may provide one or more negative molding cavities in the substrate-forming material. The one or more needle-like elements may have a first end that extends outside the interior space. The one or more methods may include removing the formed substrate from the injection mold. The one or more methods may include processing the formed substrate to form the implant device. The one or more negative molding cavities may provide one or more preformed channels in the implant device. The one or more preformed channels may be configured to allow for the passage of one or more sutures through the one or more preformed channels.

[0027] The one or more methods may include attaching one or more sutures to a first end of one or more needle-like elements. Removing the formed substrate from the injection mold may further include withdrawing one or more sutures from one or more preformed channels. The one or more withdrawn sutures may provide one or more preloaded sutures for the implant device.

[0028] The one or more methods of making the implant device may include providing a mold (e.g., injection molding). The mold may have an interior space. The one or more methods may include injecting / adding a substrate forming material into the interior space. The one or more methods may include removing the formed substrate from the injection mold. The one or more methods may include processing the formed substrate to form the implant device. The one or more methods may include inserting one or more needle elements into the implant device. The one or more needle elements (e.g., each) may have a first end that, perhaps, for example, extends outside the implant device upon insertion into the implant device. The one or more needle elements may create one or more preformed channels in the implant device. The one or more preformed channels may be configured to allow for the passage of one or more sutures through the one or more preformed channels.

[0029] The one or more methods may include attaching one or more sutures to a first end of one or more needle elements. The one or more methods may further include pushing the one or more needle elements into the implant device. The one or more pushed sutures may provide the implant device with one or more pre-loaded sutures.

[0030] One or more methods of repairing tissue of a patient with an implant device may include tensioning at least one pre-loaded suture disposed at least partially within at least one pre-formed channel of the implant device. The pre-formed channel may be configured to permit passage of the at least one pre-loaded suture through the at least one pre-formed channel. The one or more methods may include coupling a distal end of the implant device to at least a first portion of tissue over a first length of the at least one suture extending from the at least one channel at the distal end. The one or more methods may include coupling a proximal end of the implant device to at least a second portion of tissue over a second length of the at least one suture extending from the at least one channel at the proximal end. The distal and proximal ends may be coupled by a substrate of the implant device. The substrate may be configured to form a bond between the first portion of tissue and the second portion of tissue.

[0031] One or more of the methods may include the step of saturating the substrate with the patient's blood.

[0032] The elements and other features, advantages and disclosures contained herein, and the manner in which they are accomplished, will become apparent and the disclosure will be better understood with reference to the following description of various embodiments thereof, taken in conjunction with the accompanying drawings. [Brief description of the drawings]

[0033] [Figure 1] 1 is an exemplary diagram of an implant device consistent with the inventive subject matter described herein. [Diagram 2] FIG. 1 is an exemplary diagram of an implant device with at least four preformed channels consistent with the inventive subject matter described herein. [Diagram 3]1A-1C are exemplary diagrams of an implant device with one or more preformed channels and / or one or more preloaded sutures consistent with the inventive subject matter described herein. [Figure 4] 1A-1C are exemplary diagrams of an implant device with at least one preformed channel consistent with the inventive subject matter described herein. [Diagram 5] FIG. 1 is an exemplary diagram of an implant device with at least two preformed channels consistent with the inventive subject matter described herein. [Figure 6] 1A-1C are exemplary diagrams of components used to form an implant device with a preformed channel consistent with the inventive subject matter described herein. [Figure 7] 1A-1C are exemplary diagrams of components used to form an implant device with a preformed channel consistent with the inventive subject matter described herein. [Figure 8] 1A-1C are exemplary diagrams of components used to form an implant device with a preformed channel consistent with the inventive subject matter described herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same, nevertheless it will be understood that no limitation of the scope of the present disclosure (invention) is thereby intended.

[0035] Described herein is the art of an implant device that may be configured to repair tissue. FIG. 1 is an exemplary diagram of an implant device. Referring to FIG. 1, an implant device 102 may have a distal end 104 that may be configured to be connectable to at least a first portion of tissue (not shown). The device may have a distal end 106 that may be configured to be connectable to at least a second portion of tissue (not shown). The device may have a base or substrate 108 that may be configured to form an interface between the first portion of tissue and the second portion of tissue. The implant device 102 may have a longitudinal axis that may extend between the distal end and the proximal end within the base.

[0036] The substrate 108 may be porous and / or may absorb blood. The implant device 102 may immobilize autologous blood within the tissue wound site. The patient's blood may (e.g., spontaneously) form a clot and / or a (e.g., temporary) scaffold. The implant device 102 may protect the clot and / or maintain the clot within the tissue wound site. The clot may release wound healing growth factors and / or proteins that may help heal the damaged tissue. The implant device 102 may keep the blood within the tissue wound site and / or protect the blood from being prematurely washed away.

[0037] The implant device 102 can have at least one preformed channel (not shown) disposed in the substrate 108. The implant device 102 can have at least one suture (not shown) that can be at least partially preloaded into the at least one channel. In one or more scenarios, the implant device 102 can be configured such that the tissue for repair can be, for example, soft tissue, tendons, and / or ligaments, among other tissues.

[0038] In one or more scenarios, the substrate 108 may be comprised (e.g., partially and / or substantially) of, for example, collagen (e.g., human, porcine, bovine, equine, avian, fish, etc.), bovine (e.g., subcutaneous) connective tissue, and / or extracellular matrix proteins. In one or more scenarios, the substrate 108 may be comprised of one or more substances that may be saturable by human blood (e.g., 10 milliliters (mL) of a patient's blood). While dimensions may vary for a variety of reasons, an exemplary implant device 102 and / or substrate 108 may be approximately 45 millimeters (mm) in length along a longitudinal axis and approximately 22 mm in diameter.

[0039] In one or more scenarios, the implant device 102 may be (e.g., partially and / or substantially) cylindrical, (e.g., partially and / or substantially) oval (not shown), (e.g., partially and / or substantially) round (not shown), (e.g., partially and / or substantially) rectangular (not shown), (e.g., partially and / or substantially) square (not shown), or (e.g., partially and / or substantially) trapezoidal (not shown), among other shapes.

[0040] It may be useful to provide one or more preformed channels in the implant device 102 and / or to provide the implant device 102 with one or more preformed channels so that a surgical suture, for example, can be threaded through the one or more preformed channels. For example, the one or more preformed channels of the implant device 102 may facilitate the insertion / loading of a surgical suture into the implant device 102 that can be used to connect the implant device 102 to damaged tissue. The one or more preloading channels may facilitate avoiding damage to the implant device 102 during loading of a suture without the one or more preloading channels.

[0041] Techniques that allow for pre-loading of one or more sutures into the implant device 102 and / or provide the implant device 102 with one or more pre-loaded sutures may be useful. For example, one or more sutures at least partially pre-loaded into the implant device 102 can facilitate coupling of the implant device 102 to, for example, damaged tissue. The one or more pre-loaded sutures can facilitate avoiding damage to the sutures during loading of the implant device 102 and / or the sutures without the one or more pre-loaded sutures.

[0042] In one or more scenarios, the at least one preformed channel (not shown) may be formed during formation of the implant device 102 and / or at a time (e.g., substantially) proximate in time to post-shaping of the implant device 102. In one or more scenarios, the at least one suture (not shown) may be a #2 absorbable suture or may be a #2 suture. For example, a #2 Ethibond suture may be used, among other suture types and / or sizes.

[0043] 4 is an example diagram of an implant device with at least one preformed channel. With reference to FIG. 4, in one or more scenarios, the at least one preformed channel 404 can be disposed in a center of the implant device 402 along a longitudinal axis. In one or more scenarios, the at least one preformed channel 404 can have a first opening 406 disposed in a substrate 410. The implant device 402 can have a second opening 408 disposed in the substrate 410. The first opening 406 and / or the second opening 408 can be configured to allow passage of at least one suture 412 through the at least one preformed channel 404.

[0044] In one or more scenarios, the first opening 406 can be (e.g., partially and / or substantially) centered at a proximal end 406 of the implant device. The second opening 408 can be (e.g., partially and / or substantially) centered at a distal end 408 of the implant device.

[0045] 2 is an example diagram of an implant device with at least four preformed channels. With reference to FIG. 2, in one or more scenarios, the at least one preformed channel can be a first preformed channel 204. The implant device can have one or more of a second preformed channel 206, a third preformed channel 208, and a fourth preformed channel 210.

[0046] In one or more scenarios, the first preform channel 204 can have a first opening 212 in the substrate 228 and / or a second opening 214 in the substrate 228. The second preform channel 206 can have a third opening 216 in the substrate 228 and / or a fourth opening 218 in the substrate 228. The third preform channel 208 can have a fifth opening 220 in the substrate 228 and / or a sixth opening 222 in the substrate 228. The fourth preform channel 210 can have a seventh opening 224 in the substrate 228 and / or an eighth opening 226 in the substrate 228.

[0047] 3 is an example diagram of an implant device with one or more preformed channels and one or more preloaded sutures. In one or more scenarios, the at least one preloaded suture may be a first preloaded suture 306 that may be at least partially preloaded in a first preformed channel 312. The implant device 302 may have a second suture 304 that may be at least partially preloaded in a second preformed channel 314. The implant device 302 may have a third suture 308 that may be at least partially preloaded in a third preformed channel 316. The implant device 302 may have a fourth suture 310 that may be at least partially preloaded in a fourth preformed channel 318.

[0048] In one or more scenarios, the first opening 320 and / or the second opening 322 can be configured to at least allow passage of the first suture 306 through the first preform channel 312. The third opening 324 and / or the fourth opening 326 can be configured to at least allow passage of the second suture 304 through the second preform channel 314. The fifth opening 328 and / or the sixth opening 330 can be configured to at least allow passage of the third suture 308 through the third preform channel 316. The seventh opening 332 and / or the eighth opening 334 can be configured to at least allow passage of the fourth suture 310 through the fourth preform channel 318.

[0049] In one or more scenarios, the first opening 320 of the substrate 338 can be disposed in a first quadrant of the proximal end 340 at a through angle ranging from 0° to 45° relative to the longitudinal axis (not shown). The second opening 322 of the substrate 338 can be disposed in a first quadrant of the distal end 342 at a through angle ranging from 0° to 45° relative to the longitudinal axis. The third opening 324 of the substrate 338 can be disposed in a second quadrant of the proximal end 340 at a through angle ranging from 0° to 45° relative to the longitudinal axis. The fourth opening 326 of the substrate 338 can be disposed in a second quadrant of the distal end 342 at a through angle ranging from 0° to 45° relative to the longitudinal axis.

[0050] In one or more scenarios, the fifth opening 328 of the substrate 338 can be disposed in a third quadrant of the proximal end 340 at a through angle ranging from 0° to 45° relative to the longitudinal axis. The sixth opening 330 of the substrate 338 can be disposed in a third quadrant of the distal end 342 at a through angle ranging from 0° to 45° relative to the longitudinal axis. The seventh opening 332 of the substrate 338 can be disposed in a fourth quadrant of the proximal end 340 at a through angle ranging from 0° to 45° relative to the longitudinal axis. The eighth opening 334 of the substrate can be disposed in a fourth quadrant of the distal end 342 at a through angle ranging from 0° to 45° relative to the longitudinal axis.

[0051] In one or more scenarios, the first preformed channel 312, the second preformed channel 314, the third preformed channel 316, and / or the fourth preformed channel 318, and / or any of the preformed channels shown and described herein, may have a trajectory within the substrate that may be (e.g., partially and / or substantially) straight, (e.g., partially and / or substantially) diagonal (not shown), and / or (e.g., partially and / or substantially) spiral (not shown), among other trajectories.

[0052] 5 is an example diagram of an implant device with at least two preformed channels. Referring to FIG. 5, in one or more scenarios, an implant device 502 can have a first preformed channel 506 and a second preformed channel 508 disposed in a substrate 504. In one or more scenarios, a first opening 510 of the substrate 504 can be disposed in a first half of a proximal end 522 at a through angle ranging from 0° to 45° relative to a longitudinal axis of the implant device 502 and / or substrate 504. A second opening 512 of the substrate 504 can be disposed in a first half of a distal end 524 at a through angle ranging from 0° to 45° relative to the longitudinal axis. A third opening 514 of the substrate 504 can be disposed in a second half of a proximal end 522 at a through angle ranging from 0° to 45° relative to the longitudinal axis. The fourth opening 516 in the substrate 504 may be disposed in the second half of the distal end 524 at a through angle ranging from 0° to 45° relative to the longitudinal axis.

[0053] In one or more scenarios, the first opening 510 and / or the second opening 512 can be configured to at least allow passage of a first suture 518 through the first preformed channel 506. The third opening 514 and / or the fourth opening 516 can be configured to at least allow passage of a second suture 520 through the second preformed channel 508.

[0054] In one or more scenarios, implant devices with a different number of preformed channels than those shown may be derived from the description herein and are within the scope of the present invention. For example, implant devices with 3, 5, 6, 7, and / or 8 preformed channels are readily understood to be within the scope of the description herein. In one or more scenarios, a target number of preformed channels that is divisible by 2 may be useful. In one or more scenarios, the size of the implant device and / or the size / number of sutures may inform the target number of preformed channels, for example.

[0055] In one or more scenarios, implant devices with a different number of preloaded sutures than those shown may be derived from the description herein and are within the scope of the present invention. For example, implant devices with fewer or more preloaded sutures than the number of preformed channels are readily understood to be within the scope of the description herein. In one or more scenarios, a target number of preloaded sutures providing at least one preloaded suture per preformed channel may be useful. In one or more scenarios, the size of the implant device and / or the size / number of sutures may inform, for example, the target number of preloaded sutures and / or the number of preloaded sutures per preformed channel.

[0056] 6 is an illustration of a mold (e.g., an injection mold) for molding an implant device using one or more methods. With reference to FIG. 6, the one or more methods may include providing a (e.g., injection mold) mold 602. The mold may have an interior space 604. The one or more methods may include placing one or more needle-like elements 606 within the interior space 604. The needle-like elements 606 (e.g., each) may have a first end that extends outside the interior space 604. The one or more methods may include injecting / adding a substrate-forming material (not shown) into the interior space 604.

[0057] In one or more scenarios, the injection / addition of the substrate forming material may be performed under pressure or without pressure (e.g., gravity feed), perhaps for example to speed up / control the injection / addition / filling. The injection / addition of the substrate forming material may be performed at a temperature below 37° C., for example between 0° C. and 10° C. In one or more scenarios, the viscosity of the substrate forming material may provide information regarding the injection / addition / filling process.

[0058] The one or more needle elements 606 can provide one or more negative molding voids within the interior space 604. One or more methods can include processing or treating (e.g., freezing, etc.) the formed substrate to form an implant device (not shown). In one or more scenarios, the viscosity of the substrate forming material can be adjusted (e.g., increased to a "gel-like consistency," among other consistencies) by heat treatment, for example at 37° C. (e.g., 20° C.-40° C.), for a period of time, for example, 2-4 hours (e.g., 15 minutes-12 hours). In one or more scenarios, the viscosity adjustment can be based on other techniques, including energy transfer into the mold 602, which results in thermal energy that can increase the viscosity (e.g., "gelation" etc.).

[0059] In one or more scenarios, this may include lyophilization: The matrix-forming material may be frozen at -40°C (eg, perhaps between -8°C and -60°C, illustratively based on collagen and / or salt content).

[0060] In one or more scenarios, the treatment may include drying at -33°C (e.g., -10°C to -60°C) at 100 mTorr (e.g., 1000 Torr to 5 mTorr) for 25 days (e.g., 5 days to 45 days). The implant geometry may provide information regarding the treatment. For example, for an implant device in an upright position, treatment may take longer and / or utilize more "harsh" conditions than for an implant device formed "on its side", among other orientations.

[0061] The one or more negatively shaped voids can provide one or more preformed channels (not shown) in the implant device. For example, the location and / or number of needle elements 606 can match the target location and / or number of preformed channels in the implant device. The one or more preformed channels can be configured to allow passage of one or more sutures (not shown) therethrough.

[0062] One or more methods may include removing the formed substrate (not shown) from the mold 602. In one or more scenarios, the formed substrate may be removed from the mold, for example, by mechanically removing it from the mold 602 (e.g., by pulling, pushing, dropping, breaking the mold 602, using a vacuum, etc.).

[0063] One or more methods may include attaching one or more sutures (not shown) to a first end of one or more needle elements 606. In one or more methods, removing the formed substrate from the mold 602 may include withdrawing one or more sutures from one or more preformed channels. The one or more withdrawn sutures may provide the implant device with one or more preloaded sutures (not shown).

[0064] FIG. 7 is a diagram of a mold (e.g., an injection mold) for molding an implant device using one or more methods. With reference to FIG. 7, the one or more methods may include providing a (e.g., injection mold) mold 702. The mold may have an interior space 704. The one or more methods may include injecting / adding a substrate-forming material (not shown) into the interior space 704. The one or more methods may include inserting / adding one or more needle-like elements 706 into the substrate-forming material (as part of the lid of the mold 702). The one or more needle-like elements 706 may create one or more negative molding voids in the substrate-forming material. The one or more needle-like elements 706 (e.g., each) may have a first end that extends outside the interior space 704.

[0065] In one or more scenarios, one or more needle elements 706 can be inserted / added during injection / addition of the substrate-forming material (at the start of filling, at the end of filling, and / or during filling). In one or more scenarios, one or more needle elements 706 can be inserted / added during viscosity adjustment (e.g., at the start of viscosity adjustment, at the end of viscosity adjustment, and / or during viscosity adjustment). In one or more scenarios, one or more needle elements 706 can be inserted / added during (e.g., after freeze-drying) the freeze-drying process (e.g., as part of or in addition to the freezing / drying process, etc.).

[0066] The one or more methods may include removing the formed substrate from the mold 702. The one or more methods may include processing the formed substrate to form an implant device (not shown). The one or more negative mold cavities may provide one or more preformed channels (not shown) in the implant device. For example, the location and / or number of needle elements 706 may correspond to a target location and / or number of preformed channels in the implant device. The one or more preformed channels may be configured to allow for the passage of one or more sutures through the one or more preformed channels.

[0067] One or more methods may include attaching one or more sutures to a first end of one or more needle-like elements 706. One or more (e.g., each) of the first ends may have an eyelet / orifice element 708 that may be configured to receive one or more sutures 710. In one or more scenarios, removing the formed substrate from the mold 702 may include withdrawing the one or more sutures 710 from one or more preformed channels (not shown). The one or more withdrawn sutures 710 may provide an implant device with one or more preloaded sutures (not shown).

[0068] FIG. 8 is an illustration of forming an implant device using one or more methods. With reference to FIG. 8, one or more methods for making an implant device 802 may include providing a mold (e.g., injection molding) (not shown). The mold may have an interior space (not shown). One or more methods may include injecting / adding a substrate forming material (not shown) into the interior space. One or more methods may include removing a formed substrate (not shown) from the mold. One or more methods may include processing the formed substrate to form the implant device 802. One or more methods may include inserting one or more needle elements 804 into the implant device 802. The one or more needle elements 804 (e.g., each) may have a first end that extends outside the implant device, perhaps, for example, upon insertion into the implant device 802 (not shown). The one or more needle elements 804 may create one or more preformed channels (not shown) in the implant device 802. For example, the location and / or number of needle elements 804 can match the target location and / or number of preformed channels in the implant device 802. The one or more preformed channels can be configured to allow for the passage of one or more sutures therethrough.

[0069] The one or more methods may include attaching one or more sutures (not shown) to a first end of one or more needle elements. The one or more methods may include pushing (not shown) one or more needle elements 804 into the implant device 802. The one or more pushed sutures may provide the implant device with one or more pre-loaded sutures.

[0070] In one or more of the methods of making an implant device described herein, the substrate-forming material may be, for example, a collagen-based material (e.g., human, porcine, bovine, equine, avian, fish, etc.), bovine connective tissue, and / or other extracellular matrix proteins. The bovine subcutaneous connective tissue may be harvested using sterile techniques and / or formed in a sterile mold, for example, in the shape of a cylinder, among other shapes described herein.

[0071] Although actions may be illustrated in the figures in a sequential order, this should not be understood as a requirement that such actions be performed in the particular order and / or sequence illustrated, and / or that all illustrated actions be performed to achieve useful results.

[0072] Examples of inventive subject matter have been described herein. The actions recited in the claims may be performed in different orders and, unless expressly specified otherwise, useful results may still be achieved. For example, the processes depicted in the accompanying figures do not require the particular order and / or sequential order depicted to achieve useful results. Multitasking and parallel processing may be advantageous in one or more scenarios.

[0073] Although the invention has been illustrated in the drawings and described in detail in the foregoing description, it is to be understood that only certain embodiments have been shown and described, and that all changes and modifications which come within the spirit of the invention are entitled to protection.

Claims

1. 1. An implant device configured to repair tissue, the implant device comprising: a distal end configured to be connectable to at least a first portion of the tissue; a proximal end configured to be connectable to at least a second portion of the tissue; a substrate, the substrate being configured to form a joint between the first portion of the tissue and the second portion of the tissue; a longitudinal axis extending within the substrate between the distal end and the proximal end; An implant device having at least one preformed channel disposed within said substrate.

2. The implant device of claim 1 , further comprising at least one suture at least partially preloaded within the at least one preformed channel.

3. The implant device of claim 1 , wherein the implant device is configured such that the tissue is at least one of a soft tissue, a tendon, or a ligament.

4. The implant device of claim 1 , wherein the substrate is made substantially of one or more of collagen or bovine connective tissue.

5. The implant device of claim 1 , wherein the implant device is at least one of substantially cylindrical, substantially oval, substantially round, substantially rectangular, substantially square, or substantially trapezoidal.

6. The implant device of claim 1 , wherein the substrate is made of one or more substances that are saturable by human blood.

7. The implant device of claim 1 , wherein the at least one preformed channel is formed at least one of during formation of the implant device or close in time to post-forming of the implant device.

8. The implant device of claim 2 , wherein the at least one suture is at least one of an absorbable suture or a non-absorbable suture.

9. The at least one preformed channel is disposed along the longitudinal axis at a center of the implant device, the at least one preformed channel comprising: A first opening provided in the substrate; and 2. The implant device of claim 1, further comprising a second opening in the substrate, the first opening and the second opening being configured to at least allow passage of at least one suture through the at least one preformed channel.

10. 10. The implant device of claim 9, wherein the first opening is located substantially in the center of the proximal end of the implant device and the second opening is located substantially in the center of the distal end of the implant device.

11. The at least one preformed channel is a first preformed channel, and the implant device comprises: A second preformed channel; A third preformed channel; and The implant device of claim 1 , further comprising a fourth preformed channel.

12. The implant device may further comprise: the first preformed channel further comprising a first opening in the substrate and a second opening in the substrate; the second preformed channel further comprising a third opening in the substrate and a fourth opening in the substrate; the third preform channel further comprises a fifth opening in the substrate and a sixth opening in the substrate; and The implant device of claim 11 , wherein the fourth preformed channel is further configured to have a seventh opening disposed in the substrate and an eighth opening disposed in the substrate.

13. a first suture at least partially preloaded within the first preformed channel; a second suture at least partially preloaded within the second preformed channel; a third suture at least partially preloaded within the third preformed channel; and The implant device of claim 12 , further comprising a fourth suture at least partially preloaded within the fourth preformed channel.

14. The implant device may further comprise: the first opening and the second opening are configured to at least permit passage of a first suture through the first preformed channel; the third opening and the fourth opening are configured to permit passage of a second suture through the second preform channel; the fifth opening and the sixth opening are configured to permit passage of a third suture through the third preform channel; The implant device of claim 12 , wherein the seventh opening and the eighth opening are configured to permit passage of a fourth suture through the fourth preform channel.

15. The implant device further comprises: a first opening in the substrate disposed in a first quadrant of the proximal end at a through angle ranging from 0° to 45° relative to the longitudinal axis; a second opening in the substrate disposed in a first quadrant of the distal end at a through angle ranging from 0° to 45° relative to the longitudinal axis; a third opening in the substrate disposed in a second quadrant of the proximal end at a through angle ranging from 0° to 45° relative to the longitudinal axis; a fourth opening in the substrate disposed in a second quadrant of the distal end at a through angle ranging from 0° to 45° relative to the longitudinal axis; a fifth opening in the substrate disposed in a third quadrant of the proximal end at a through angle ranging from 0° to 45° relative to the longitudinal axis; a sixth opening in the substrate is disposed in a third quadrant of the distal end at a through angle ranging from 0° to 45° relative to the longitudinal axis; a seventh opening in the substrate is disposed in a fourth quadrant of the proximal end at a through angle ranging from 0° to 45° relative to the longitudinal axis; 13. The implant device of claim 12, wherein the eighth opening in the substrate is configured to be disposed in a fourth quadrant of the distal end at a through angle ranging from 0° to 45° relative to the longitudinal axis.

16. The at least one preformed channel further comprises: the first opening is disposed at the proximal end at a through angle ranging from 0° to 45° relative to the longitudinal axis; and The implant device of claim 10 , wherein the second opening is configured to be disposed at the distal end at a through angle ranging from 0° to 45° relative to the longitudinal axis.

17. 12. The implant device of claim 11, further configured such that at least one of the first preformed channel, the second preformed channel, the third preformed channel, or the fourth preformed channel has a track in the substrate that is at least one of substantially straight, substantially diagonal, or substantially spiral.

18. The at least one preformed channel is a first preformed channel, and the implant device comprises:

2. The implant device of claim 1, further comprising a second preformed channel, the first preformed channel further comprising a first opening in the substrate and a second opening in the substrate, the second preformed channel further comprising a third opening in the substrate and a fourth opening in the substrate.

19. The implant device may further comprise: the first opening in the substrate is disposed in a first half of the proximal end at a through angle in the range of 0° to 45° relative to the longitudinal axis; the second opening in the substrate is disposed in the first half of the distal end at a through angle ranging from 0° to 45° relative to the longitudinal axis; the third opening in the substrate is disposed in the second half of the proximal end at a through angle ranging from 0° to 45° relative to the longitudinal axis; and 20. The implant device of claim 18, wherein the fourth opening in the base material is configured to be disposed in the second half of the distal end at a through angle ranging from 0° to 45° relative to the longitudinal axis.

20. 1. A method of making an implant device for repairing tissue, comprising: providing an injection mold, the injection mold having an interior space; placing one or more needle-like elements within the interior space, the needle-like elements having a first end extending outside the interior space; Injecting a substrate-forming material into the interior space, the one or more needle-like elements providing one or more negative molding voids within the interior space; removing the formed substrate from the injection mold; The method includes processing the formed substrate to form the implant device, wherein the one or more negative molding cavities provide one or more preformed channels within the implant device, the one or more preformed channels configured to allow passage of one or more sutures therethrough.

21. 21. The method of claim 20, further comprising the step of attaching one or more sutures to the first ends of the one or more needle-shaped elements, and wherein the step of removing the formed substrate from the injection mold further comprises the step of withdrawing the one or more sutures from the one or more preformed channels, the one or more withdrawn sutures providing the implant device with one or more pre-loaded sutures.

22. 21. The method of claim 20, wherein the matrix forming material is at least one of collagen or bovine connective tissue.

23. 21. The method of claim 20, wherein the formed substrate is saturable with human blood.

24. 1. A method of making an implant device for repairing tissue, comprising: providing an injection mold, the injection mold having an interior space; Injecting a substrate-forming material into the internal space; The method includes inserting one or more needle-like elements into the base material, the one or more needle-like elements creating one or more negative molding voids in the base material, the one or more needle-like elements having a first end extending outside the interior space; removing the formed substrate from the injection mold; The method includes processing the formed substrate to form the implant device, wherein the one or more negative molding cavities provide one or more preformed channels within the implant device, the one or more preformed channels configured to allow passage of one or more sutures therethrough.

25. The method further includes attaching one or more sutures to the first ends of the one or more needle-like elements, and the step of removing the formed substrate from the injection mold comprises:

25. The method of claim 24, further comprising the step of withdrawing the one or more sutures from the one or more preformed channels, the one or more withdrawn sutures providing the implant device with one or more pre-loaded sutures.

26. 25. The method of claim 24, wherein the matrix forming material is made from one or more of collagen or bovine connective tissue.

27. 25. The method of claim 24, wherein the formed substrate is saturable with human blood.

28. 1. A method of making an implant device for repairing tissue, comprising: Providing an injection mold, the injection mold having an interior space; Injecting a substrate-forming material into the interior space; removing the formed substrate from the injection mold; processing the shaped substrate to form the implant device; A method comprising the steps of inserting one or more needle elements into the implant device, the one or more needle elements having a first end that extends outside of the implant device upon insertion into the implant device, the one or more needle elements creating one or more preformed channels in the implant device, the one or more preformed channels configured to allow passage of one or more sutures therethrough.

29. attaching one or more sutures to the first ends of the one or more needle elements; 30. The method of claim 28, further comprising the step of: advancing the one or more needle elements into the implant device, the one or more advanced sutures providing the implant device with one or more pre-loaded sutures.

30. 30. The method of claim 28, wherein the matrix forming material is made from one or more of collagen or bovine connective tissue.

31. 30. The method of claim 28, wherein the formed substrate is saturable with human blood.

32. 1. A method of repairing tissue in a patient with an implant device, the method comprising: applying tension to at least one pre-loaded suture disposed at least partially within at least one pre-formed channel of the implant device, the pre-formed channel configured to permit passage of the at least one pre-loaded suture therethrough; coupling a distal end of the implant device to at least a first portion of the tissue over a first length of the at least one suture extending from the at least one channel at the distal end; The method includes coupling a proximal end of the implant device to at least a second portion of the tissue over a second length of the at least one suture extending from the at least one channel at the proximal end, the distal end and the proximal end being coupled by a substrate of the implant device, the substrate being configured to form a bond between the first portion of the tissue and the second portion of the tissue.

33. 33. The method of claim 32, further comprising the step of saturating the substrate with the patient's blood.

34. 33. The method of claim 32, wherein the patient tissue is at least one of a soft tissue, a tendon, or a ligament.

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