WO2025174792A1 - Échafaudages tissulaires fixés de manière non adhésive - Google Patents

Échafaudages tissulaires fixés de manière non adhésive

Info

Publication number
WO2025174792A1
WO2025174792A1 PCT/US2025/015462 US2025015462W WO2025174792A1 WO 2025174792 A1 WO2025174792 A1 WO 2025174792A1 US 2025015462 W US2025015462 W US 2025015462W WO 2025174792 A1 WO2025174792 A1 WO 2025174792A1
Authority
WO
WIPO (PCT)
Prior art keywords
scaffold
tissue
tissue scaffold
region
attachment element
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/015462
Other languages
English (en)
Inventor
Luke Aram
Nathan CASTRO
Douglas Snell
Benjamin HOLMES
Sean CHURCHILL
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nanochon Inc
Original Assignee
Nanochon Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nanochon Inc filed Critical Nanochon Inc
Publication of WO2025174792A1 publication Critical patent/WO2025174792A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

Links

Classifications

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    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
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    • A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • A61F2002/30879—Ribs
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    • A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • A61F2002/30884—Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
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    • A61F2002/30886—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts externally-threaded
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    • A61F2002/30891—Plurality of protrusions
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    • A61F2002/3092—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored structure
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    • A61F2002/3093—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for promoting ingrowth of bone tissue
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    • A61F2002/4622—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof having the shape of a forceps or a clamp
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    • A61F2002/4625—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use
    • A61F2002/4627—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/4677—Special tools for implanting artificial joints using a guide wire

Definitions

  • an undercut tool for preparing at least one groove in a host tissue comprising: a cylindrical body featuring two cutting teeth designed to create at least one groove in a socket of the host tissue; and a cannula configured to allow for a placement of a guide pin during use.
  • each cutting tooth is disposed on an outer end of a first arm and a second arm extending from a vertex of the undercut tool.
  • an outer diameter of an end of the undercut tool containing the cutting teeth is larger than the socket of the host tissue, requiring compression to fit into the socket.
  • the undercut tool comprises a compression mechanism that allows a user to compress the two cutting teeth for retraction during placement over the guide pin and into the socket.
  • the cutting teeth extend to prepare the at least one groove in the host tissue upon release, wherein the undercut tool requires a compression to retract the teeth for removal.
  • the undercut tool is made of a biocompatible material.
  • an insertion tool for placing a tissue scaffold in a host tissue comprising: a gripping instrument to compress the tissue scaffold during insertion; and a tube with a pocket to hold the tissue scaffold during insertion.
  • insertion tool comprises two tips for gripping the tissue scaffold.
  • the insertion tool is used for compressing the tissue scaffold.
  • the insertion tool comprises at least four relief flutes that allow the tube to receive the tissue scaffold while applying a clamping force to hold the tissue scaffold.
  • the insertion tool further comprises a release button that retracts the tube.
  • the insertion tool is made of a biocompatible material.
  • the insertion tool is designed to provide tactile feedback to a user during the insertion process.
  • the pocket is cylindrical. In some cases, the pocket is about 0 mm to about 12 mm deep. In some cases, the tube holds a top half of the tissue.
  • a surgical tool kit for installing a tissue scaffold comprising: an alignment guide for ensuring proper positioning of surgical tools; a guide pin for providing a reference point in a host tissue; a punch for scoring the host tissue; a cannulated reamer for preparing a socket in the host tissue; a trial implant for evaluating the prepared socket in the host tissue; an undercut tool for preparing at least one groove in the host tissue; and an insertion tool for placing the tissue scaffold in the host tissue.
  • the surgical tool kit is made of a biocompatible material.
  • the host tissue comprises a femur bone.
  • the cannulated reamer is a hollow, cylindrical tool with at least one cutting tooth designed for creating the socket of varying diameters in the host tissue, and includes a depth stop to prevent over-reaming over at least one predetermined cutting depth.
  • the trial implant is designed to match a thickness and a diameter of a final tissue scaffold implant, wherein the trial implant comprises visual indicators on an outer body of the trial implant to assist a user in evaluating a fit and alignment.
  • the trial implant has a 1 mm-mark on an outer surface of the trial implant, wherein the 1 mm-mark is visible to the user for evaluating the fit and alignment of the trial implant within the prepared socket in the host tissue.
  • the undercut tool comprises a compression mechanism that allows a user to compress the two cutting teeth for retraction during placement over the guide pin and into the socket, and upon release, the cutting teeth extend to prepare the groove in the bone, with the tool requiring compression to retract the teeth for removal.
  • the insertion tool is a gripping instrument that functions similarly to needle nose pliers, designed to compress the tissue scaffold during insertion.
  • the insertion tool includes two tips that are optimized for a shape of the tissue scaffold, ensuring a secure grip and effective compression during placement.
  • the tissue scaffold comprises at least one solid snap ring designed for secure fixation of the tissue scaffold on the host tissue.
  • the surgical tool kit is sterilized by steam autoclaving.
  • the tissue scaffold is sterilized before use.
  • the tissue scaffold is sterilized by steam autoclaving.
  • the installation of the tissue scaffold is conducted within about 2 hours post sterilization.
  • the tissue scaffold is hydrated prior to installation.
  • the tissue scaffold is packed in a container prior to installation.
  • the container is made of glass, polymer, or metal.
  • the container is filled with an aqueous solution.
  • the surgical tool kit is organized and fixed in place within a metal container.
  • the metal container can be sterilized.
  • the surgical tool kit comprises at least one size of each tool.
  • a method of installing a tissue scaffold comprising: positioning an alignment guide to ensure proper alignment of surgical tools relative to a lesion in a host tissue; inserting a guide pin into the host tissue to provide a reference point; using a punch to score the host tissue at the location of the guide pin; utilizing a cannulated reamer to prepare a socket in the host tissue; evaluating the prepared socket in the host tissue with a trial implant to ensure proper fit and alignment; employing an undercut tool to prepare at least one groove in the host tissue; and placing the tissue scaffold into the prepared socket using an insertion tool.
  • the lesion in the host tissue is a chondral lesion.
  • the method further comprises drilling the guide pin into the host tissue until the depth stop line on the guide pin is aligned with an opening of the alignment guide. In some cases, the method further comprises selecting the punch from a plurality of predefined-size punches to score the host tissue. In some cases, the punch is placed over the guide pin. In some cases, the method further comprises applying axial pressure to the punch while rotating the punch to score the host tissue. In some cases, the method further comprises selectingthe reamer from a plurality of predefined-size reamers to prepare a cylindrical socket for receiving the tissue scaffold. In some cases, a depth stop is assembled onto a shaft of the reamer, wherein the reamer is turned until the reamer is locked before use.
  • the scaffold region and the attachment element comprise a equilibrium modulus of at least about 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, or at least about 6.0 megaPascals (MPa).
  • MPa megaPascals
  • the scaffold region and the attachment element comprise an equilibrium modulus of less than about 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, or less than about 6.0 megaPascals (MPa).
  • MPa megaPascals
  • the scaffold region and the attachment element comprise a phase angle of at least about 1.9, 2.0, 2.1, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6,
  • the scaffold region and the attachment element comprise a phase angle of less than about 1.9, 2.0, 2.1, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8,
  • a tissue scaffold comprising: a cylindrical scaffold region, wherein an end of the cylindrical scaffold comprises a recessed portion; and an attachment element.
  • the recess is configured to mate to a portion of a tissue.
  • the portion of the tissue has been cut to the shape of the recess.
  • the portion of a tissue comprises bone or cartilage.
  • the attachment element encapsulates at least a portion of the end of the cylindrical scaffold region.
  • the attachment element engages a tissue.
  • a tissue scaffold comprising: a porous region; and a solid threaded element that encapsulates at least a portion of the porous region.
  • the solid threaded element comprises a compressible material.
  • the porous region comprises a scaffold region.
  • the scaffold region comprises a plurality of layers.
  • the plurality of layers comprises at least one rotational offset between a first layer of the plurality of layers and a second layer of the plurality of layers.
  • the scaffold region comprises a plurality of layer densities.
  • a bone preparation tool comprising: a cylindrical shaft; an end of the cylindrical shaft comprising two cutting teeth, wherein the end is hollow and compressible; and a cannula that extends from the center of the cylindrical shaft.
  • the bone preparation tool further comprises a handle portion opposite the hollow and compressible end of the cylindrical shaft.
  • the hollow and compressible end of the cylindrical shaft comprises cutouts for compression.
  • the two cutting teeth are configured to cut a groove in a bone of a patient.
  • the cannula extends past the end of the cylindrical shaft.
  • a scaffold insertion tool comprising: a cylindrical shaft; an end of the cylindrical shaft comprising a receiving end configured to receive a scaffold implant; and at least two engagement tines running parallel to the length of the cylindrical shaft and each comprising a proximal end, a middle portion, and a distal end, wherein the distal end of the engagement tines are configured to engage at least a portion of the received scaffold implant.
  • the engagement tines are configured to release the received scaffold implant when depressed at the middle portion.
  • a scaffold insertion tool comprising: a cylindrical shaft; a hollow distal end of the cylindrical shaft configured to receive and hold an inserted scaffold implant; a pushing portion located in the cylindrical shaft, wherein a distal end is configured to be in contact with the inserted scaffold implant; and a button on the external surface of the cylindrical shaft, connected to the pushing portion; wherein the button is configured engage the pushing portion to push the inserted scaffold out of the hollow distal end of the cylindrical shaft.
  • the hollow distal end comprises a plurality of cutouts such that the hollow distal end flexes to receive the inserted scaffold implant. In some embodiments, the flex of the hollow distal end holds the inserted scaffold implant in place.
  • a scaffold insertion tool comprising: a first lever portion comprising a first distal end, a first middle portion, and a first proximal end, wherein the first distal end comprises a first compression tine; and a second lever portion comprising a second distal end, a second middle portion, and a second proximal end, wherein the second distal end comprises a second compression tine; wherein the first lever portion and second lever portion are pivotally coupled at the first middle portion and the second middle portion, wherein the first compression tine and the second compression tine are configured to engage a portion of a tissue scaffold.
  • FIGS. 2A and 2B illustrate a skew view and a side view of a tissue scaffold comprising a scaffold region and an attachment element in a snap ring configuration.
  • FIG. 3 illustrates a top view and a side view of a tissue scaffold comprising a scaffold region and an attachment element in a snap ring configuration.
  • FIG. 5D illustrates a top view (bottom left panel), a front view (top left panel), a left view (top right panel), and a trimetric view (bottom right panel) of the tissue scaffold with an attachment element in a snap ring configuration.
  • FIG. 7 illustrates comparing a drilled socket to a tissue scaffold trial reference.
  • FIG. 9 illustrates cutting a groove in a socket.
  • FIGS. 10A-10C illustrate the bone of a patient after drilling a socket, comparing the socket to an tissue scaffold trial reference, and after cutting a groove in the socket.
  • FIG. 13 illustrates atop view and a side view of a tissue scaffold comprising a scaffold region and an attachment element in a press-fit ring configuration.
  • FIGS. 14A and 14B illustrate a top view, a side view, and a cross section of a tissue scaffold comprising a scaffold region and an attachment element in a press-fit ring configuration.
  • FIGS. 15A and 15B illustrate skew views of additional embodiments of a tissue scaffold comprising a scaffold region and an attachment element in a press-fit ring configuration.
  • FIGS. 16A and 16B illustrate additional side and skew views of a tissue scaffold comprising a scaffold region and an attachment element in a press-fit ring configuration.
  • FIG. 16C illustrates a top view (bottom left panel), a front view (top left panel), a left view (top right panel), and a trimetric view (bottom right panel) of an exemplary tissue scaffold having an attachment element in a press-fit ring configuration.
  • FIG. 22 illustrates a tool used to tap a thread in a tissue of a patient.
  • FIG. 23 illustrates tapping a thread in a tissue of a patient.
  • FIG. 31 illustrates cartilage and bone observed at 8-month equine study.
  • the scaffold region is compressible.
  • the attachment element is compressible.
  • both the scaffold region and the attachment element are compressible.
  • the scaffold region and the attachment element may comprise individual mechanical characteristics, such as rigidity or compressibility.
  • the tissue scaffold may comprise an overall rigidity based at least in part on an interaction of the scaffold region with the attachment element. In some embodiments, the tissue scaffold may be compressible by at least about 5%, 10%, 15%, 20%, 25%, 30%, 40%, 45%, or at least about 50%.
  • the attachment element may comprise a polycarbonate, an aliphatic polyester, an aromatic polyester, a polyurethane, a polyamide, a polyvinyl alcohol (PVA), a lactide, a polyolefin, or combinations thereof.
  • a polyurethane may be a thermoplastic polyurethane.
  • a lactide may be a linear lactide.
  • a lactide may be an aromatic lactide.
  • the attachment element may comprise a polyvinyl alcohol composite material.
  • the attachment element may comprise a polymer with a solubility in an aqueous environment that is greater than polyvinyl alcohol.
  • the attachment element may comprise a polymer with a degradation rate in an aqueous environment that is greater than polyvinyl alcohol.
  • the attachment element may comprise a combination of a water soluble material and a material that is not water-soluble.
  • the attachment element may comprise a combination of a material that degrades in water and a material that does not degrade in water.
  • the attachment element may comprise a material with a degradation rate in water that is at least 5 times slower than the degradation rate of polyvinyl alcohol in water.
  • the scaffold region and the attachment element may comprise a unitary body.
  • the scaffold region and the attachment element may be assembled together as a unitary body. The assembly may be accomplished by 3D printing the scaffold region and the attachment element as a unified body. 3D printing may include fused filament fabrication, fused layer deposition, stereolithography, selective laser sintering, or multijet fusion.
  • the plane may intersect along an x, y, or z axis, or along a longitudinal or radial axis.
  • the attachment element comprises a geometry.
  • the geometry may be a ring, a toroid, a thread, a rectangle, a shape rotated around a circumference of the scaffold region, or a combination thereof.
  • the geometry may be a radial geometry.
  • the tissue scaffold comprises a recessed portion.
  • the recessed portion may comprise a cylindrical shape, a rectangular shape, an elliptical shape, or a combination thereof.
  • the recessed portion may be formed by the scaffold region.
  • the recessed portion may be formed by the attachment element.
  • the recessed portion may be formed by the combination of the geometries of the scaffold region and the attachment element.
  • the depth of the recess may be at least about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or at least about 20 millimeters (mm) thick.
  • the recessed portion maybe configured to engage a tissue of a patient.
  • the recessed portion may be shaped to receive a tissue plug in a patient.
  • a tissue plug in a patient may be shaped to insert into a recessed portion of a tissue scaffold.
  • a tissue plug may comprise a bone plug.
  • a tissue plug may comprise a socket.
  • a retaining tab protrudes less than about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, or less than about 2.0 millimeters (mm) from the surface of the scaffold region.
  • the retaining tab may be extruded in a shape to engage a tissue of a patient.
  • the retaining tab may be shaped to fit a groove in a patient.
  • the groove may be cut in a tissue in a circular shape, an elliptical shape, a rectangular shape, or a shape resulting from the combinations of two or more shapes.
  • the attachment element may comprise 1, 2, 3, 4, 5, 6, or more retaining tabs.
  • the attachment element may join at a face of the scaffold region, or encapsulate at least a portion of the tissue scaffold.
  • the fixation region has two retention tabs, each retention tab of the two retention tabs disposed on opposing sides of the tissue scaffold. In some cases, the fixation region comprises three or more retention tabs. In some cases, the fixation region is circular or substantially circular in shape. In some cases, the at least one retention tab comprises a protrusion which extends in a radial direction from the fixation region. In some cases, the protrusion is configured to contact the groove or socket and anchor the tissue scaffold into the groove or socket. In some cases, a top surface of the fixation region is attached to a bottom surface of the scaffold region. In some cases, the fixation region is solid. In some cases, the fixation region has an infill density of about 100%.
  • FIGS. 2 A and 2B illustrate a skew view and a side view of a tissue scaffold comprising a scaffold region and an attachment element in a snap ring configuration.
  • the attachment element may comprise at least retention tab .
  • the attachment element may comprise, 1, 2, 3, or more retention tabs.
  • the attachment element may be shaped to engage a tissue of a patient.
  • the attachment element may comprise a convex top surface.
  • the top surface may be flexible.
  • the top surface may contour to a patient’s anatomy.
  • FIG. 2A illustrates a skew view of a tissue scaffold comprising an attachment element in a snap ring configuration, in which a cylindrical recessed portion of the tissue scaffold can be seen.
  • FIG. 1A illustrates a skew view of a tissue scaffold comprising an attachment element in a snap ring configuration, in which a cylindrical recessed portion of the tissue scaffold can be seen.
  • the scaffold region 201 may comprise subregions.
  • the subregions may comprise a top layer 202, and a layered lattice 203.
  • the top layer 202 may comprise a thickness of 0.2 to 1.0 mm.
  • the top layer 202 may comprise a thickness of 0.2 mm.
  • the top layer 202 may comprise one layer, or multiple layers.
  • the layered lattice 203 may comprise a thickness of 0.8 to 4.0 mm.
  • the layered lattice 203 may comprise a thickness of 1.8 mm.
  • the layered lattice 203 may comprise from about 4 layers to about 40 layers.
  • the attachment element 204 may comprise a thickness of 0.8 to 8.0 mm.
  • the attachment element 204 may comprise a thickness of 2.0 mm.
  • the attachment element 204 may comprise from about 4 layers to about 80 layers.
  • FIG. 7 illustrates comparing a drilled socket to a tissue scaffold trial reference 701.
  • the tissue scaffold trial reference can comprise an end matching the geometry of the tissue scaffold.
  • the tissue scaffold trial reference may fit over the guide pin and into the socket.
  • a surgeon can evaluate the size and depth of the socket based at least in part on the tissue scaffold trial reference.
  • a surgeon can make an adjustment to the socket based on a comparison of the socket to the tissue scaffold trial reference.
  • the at least one press-fit ring is disposed along the outer circumference of the tissue scaffold. In some cases, an outer surface of the at least one press-fit ring is configured to contact the host tissue and anchor the tissue scaffold into the host tissue. In some cases, the at least one press-fit ring is solid. In some cases, the at least one press- fit ring has an infill density of about 100%. In some cases, the scaffold region and the at least one press-fit ring are integrally formed as a single unit. In some cases, the scaffold region and the at least one press fit ring are manufactured using a three-dimensional printing process.
  • FIG. 13 illustrates a top view and a side view of a tissue scaffold comprising a scaffold region 1301 and an attachment element in a press-fit ring configuration 1302.
  • FIG. 14A illustrates a side view and a cross section view of a tissue scaffold with an attachment element comprising a press-fit ring configuration.
  • the tissue scaffold can comprise at least two porous surfaces that facilitate cartilage ingrowth. These surfaces can be a tissue scaffold periphery 1401, and a tissue scaffold bottom 1402.
  • the tissue scaffold shown comprises a recessed portion 1403.
  • FIG 14B illustrates a top view of the tissue scaffold.
  • FIG. 15 A illustrates a skew view of the bottom an embodiment of a tissue scaffold comprising a scaffold region and an attachment element in a press-fit ring configuration, wherein there are three press-fit rings.
  • FIG. 15B illustrates a skew view of the top of the tissue scaffold comprising three press-fit rings.
  • FIG. 16A illustrates a side view of a tissue scaffold comprising a scaffold region and an attachment element in a press-fit ring configuration.
  • FIG. 16B illustrates a skew view of a tissue scaffold comprising a scaffold region and an attachment element in a press-fit ring configuration.
  • FIG. 16C illustrates atop view (bottom left panel), a front view (top left panel), a left view (top right panel), and a trimetric view (bottom right panel) of a tissue scaffold with an attachment element in a press-fit ring configuration.
  • the pushing portion may contact the tissue scaffold when inserted into the pocket.
  • the hollow distal end may comprise a tube 1706.
  • the tube may comprise 1, 2, 3, 4, or more relief flutes 1707.
  • the tube may flex and receive the implant while applying a clamping force to hold the implant.
  • pushing the button retracts the tube.
  • the retraction of the tube may cause the tissue scaffold to be pushed out of the hollow distal end by the pushing portion.
  • a surgeon can place the implant into a socket, press the button to retract the tube, and then place the implant all the way in.
  • the surgeon may place the implant halfway into the socket, or about 2mm into the socket.
  • the surgeon may place the implant with one hand while holding an arthroscopic camera (or other instrument) with their other hand.
  • the at least two circumferential threads are two helical threads extended symmetrically around a central axis of the scaffold region and a central axis of the fixation region. In some cases, the two helical threads are extended along an outer surface of the scaffold region and an outer surface of the fixation region, wherein the helical threads have a predetermined pitch and/or lead angle. In some cases, the two helical threads have two opposite cut-out portions configured to provide two insertion slots for engaging a tool to facilitate the rotation of the tissue scaffold.
  • the two opposite cut-out portions are extended partially along the outer surface of the scaffold region and the outer surface of the fixation region, wherein the two opposite cut-out portions are parallel with the central axis of the scaffold region and the central axis of the fixation region.
  • FIGS. 18A and 18B illustrate skew views of a tissue scaffold comprising a threaded attachment element.
  • the thread is a double start thread.
  • the thread is a 16mm diameter x 3 mm pitch thread.
  • the thread is a SP4 Bottle thread.
  • FIG. 18A illustrates a top skew view
  • FIG. 18B illustrates a bottom skew view.
  • FIGS. 19A and 19B illustrate a top view and a side view of a tissue scaffold comprising a attachment element comprising threads 1901.
  • the tissue scaffold comprises one or more insertion slots 1902.
  • the insertion slot may be a cutout in the tissue scaffold.
  • the insertion slot may receive a tool for rotating the tissue scaffold.
  • FIG. 20A illustrates a side view and a cross section view of a tissue scaffold comprising a threaded attachment element.
  • the tissue scaffold can comprise at least two porous surfaces that facilitate cartilage ingrowth. These surfaces can be a tissue scaffold periphery 2001, and a tissue scaffold bottom 2002.
  • the tissue scaffold shown comprises a recessed portion 2003.
  • FIG 20B illustrates a top view of the tissue scaffold.
  • FIG. 24 illustrates an insertion tool 2400 used to thread a tissue scaffold into a tissue of a patient.
  • the insertion tool may comprise a cylindrical shaft 2401; an end of the cylindrical shaft comprising a receiving end 2402 configured to receive a tissue scaffold 2403; and one or more engagement tines 2404 running parallel to the length of the shaft 2401 and each comprising a proximal end 2405, a middle portion 2406, and a distal end 2407.
  • the one or more engagement tines may be configured to engage one or more insertion slots 2408 of a tissue scaffold.
  • applying pressure to the middle portion 2406 can engage or disengage a tissue scaffold from the distal end 2407 of the engagement tines.
  • FIG. 25 illustrates a tissue scaffold insertion tool 2500 configured to compress a tissue scaffold 2501.
  • the insertion tool comprises tips or tines 2502 that are optimized for the shape of a tissue scaffold.
  • the tissue scaffold insertion tool comprises: a first lever portion 2503 comprising a first distal end 2504, a first middle portion 2505, and a first proximal end 2506, wherein the first distal end comprises a first compression tine 2507 ; and a second lever portion 2508 comprising a second distal end 2509, a second middle portion 2510, and a second proximal end 2511, wherein the second distal end comprises a second compression tine 2512; wherein the first lever portion 2503 and second lever portion 2508 are pivotally coupled at the first middle portion 2504 and the second middle portion 2510, wherein the first compression tine 2507 and the second compression tine 2512 are configured to engage a portion of a tissue scaffold 2501.
  • the tissue scaffold is compressible.
  • the tissue scaffold is compressible.
  • the tissue scaffold is compressible.
  • a tissue scaffold may comprise a scaffold region.
  • the scaffold region maybe made from new tissue growth materials and designs compatible with fused filament fabrication additive manufacturing.
  • the scaffold region may comprise 3D printable synthetic bone, vascular, and cartilage structure from these materials.
  • the tissue scaffold may be efficacious and safe for a human clinical trial.
  • 3D printed microporous structure may have physical characteristics, compressive and elastic properties very similar to native cartilage at the osteochondral region. These characteristics may accelerate the formation of new bone and vascular networks.
  • the tissue scaffold may be 3D printed to form a transitional structure which looks like osteochondral tissue.
  • the tissue scaffold may replace the function of the lost cartilage.
  • the tissue scaffold may induce new vascularized subchondral bone to form in the tissue scaffold, anchoring it permanently in place and repairing an articular surface of a patient.
  • the tissue scaffold may support mechanical loading similar to native bone and cartilage.
  • the tissue scaffold may promote fast and efficient fluid perfusion, namely of arterial blood, throughout the tissue scaffold.
  • Embodiment 2 The tissue scaffold of embodiment 1, wherein the tissue scaffold is configured to have an interference fit with the host tissue.
  • Embodiment 3 The tissue scaffold of embodiment 1 or 2, wherein the socket is a bone socket.
  • Embodiment4 The tissue scaffold of any one of embodiments 1-3, wherein the at least one press-fit ring is at least two press-fit rings.
  • Embodiment 5 The tissue scaffold of embodiment 4, wherein each press-fit ring of the at least two press-fit rings is separated by a distance of at least 0.05mm.
  • Embodiment 6 The tissue scaffold of any one of embodiments 1-5, wherein the at least one press-fit ring has a ring-like structure.
  • Embodiment ? The tissue scaffold of any one of embodiments 1-6, wherein the at least one press-fit ring is disposed along the outer circumference of the tissue scaffold.
  • Embodiment 8 The tissue scaffold of any one of embodiments 1-7, wherein an outer surface of the at least one press-fit ring is configured to contact the host tissue and anchor the tissue scaffold into the host tissue.
  • Embodiment 14 The tissue scaffold of embodiment 13, wherein the tissue scaffold is compressible to a compressed state.
  • Embodiment 15 The tissue scaffold of embodiment 14, wherein the tissue scaffold is, after being compressed, capable of expanding to an expanded state.
  • Embodiment 16 The tissue scaffold of embodiment 15, wherein the tissue scaffold in the expanded state is within at least about 90% of an original size of the tissue scaffold.
  • Embodiment 17 The tissue scaffold of embodiment 15 or 16, wherein the at least one retention tab is configured to engage the groove or socket prepared in the host tissue when the tissue scaffold is in the expanded state.
  • Embodiment 18 The tissue scaffold of any one of embodiments 13-17, wherein the fixation region has two retention tabs, each retention tab of the two retention tabs disposed on opposing sides of the tissue scaffold.
  • Embodiment 19 The tissue scaffold of any one of embodiments 13-18, wherein the fixation region comprises three or more retention tabs.
  • Embodiment 21 The tissue scaffold of any one of embodiments 13-20, wherein the at least one retention tab comprises a protrusion which extends in a radial direction from the fixation region.
  • Embodiment 22 The tissue scaffold of embodiment 21, wherein the protrusion is configured to contact the groove or socket and anchor the tissue scaffold into the groove or socket.
  • Embodiment 23 The tissue scaffold of any one of embodiments 13-22, wherein a top surface of the fixation region is attached to a bottom surface of the scaffold region.
  • Embodiment 25 The tissue scaffold of any one of embodiments 13-24, wherein the fixation region has an infill density of about 100%.
  • Embodiment 26 The tissue scaffold of any one of embodiments 13-25, wherein the fixation region comprises a plurality of layers.
  • Embodiment 27 The tissue scaffold of embodiment 26, wherein the fixation region comprises 2 to 10 layers.
  • Embodiment 28 The tissue scaffold of embodiment 26, wherein the fixation region comprises 2 to 80 layers.
  • Embodiment 29 The tissue scaffold of any one of embodiments 13-28, wherein the fixation region is about 0.8 mm to about 8.0 mm in thickness.
  • Embodiment 30 The tissue scaffold of any one of embodiments 13-29, wherein the fixation region comprises a cylindrical pocket.
  • Embodiment 31 The tissue scaffold of embodiment 30, wherein the cylindrical pocket is sized and shaped to accept a bone post in the host tissue.
  • Embodiment 32 The tissue scaffold of any one of embodiments 13-31, wherein the fixation region is a substantially circular body having an upper surface, a lower surface, a thickness extending between the upper and lower surfaces, and a central through-hole extending along an axis perpendicular to the plane of the fixation region.
  • Embodiment 34 The tissue scaffold of any one of embodiments 13-33, wherein the scaffold region and the fixation region are manufactured using a three-dimensional printing process.
  • Embodiment 35 A tissue scaffold comprising: (a) a scaffold region; and (b) a fixation region comprising at least one circumferential thread configured to engage with at least one groove or socket prepared on a host tissue.
  • Embodiment 38 The tissue scaffold of embodiment 37, wherein the at least two circumferential threads are extended along an outer surface of the scaffold region and an outer surface of the fixation region.
  • Embodiment 39 The tissue scaffold of embodiment 37, wherein the at least two circumferential threads are two helical threads extended symmetrically around a central axis of the scaffold region and a central axis of the fixation region.
  • Embodiment 40 The tissue scaffold of embodiment 39, wherein the two helical threads are extended along an outer surface of the scaffold region and an outer surface of the fixation region, wherein the helical threads have a predetermined pitch and/or lead angle.
  • Embodiment 41 The tissue scaffold of embodiment 39, wherein the two helical threads have two opposite cut-out portions configured to provide two insertion slots for engaging a tool to facilitate the rotation of the tissue scaffold.
  • Embodiment 42 The tissue scaffold of embodiment41, wherein the two opposite cut-out portions are extended partially along the outer surface of the scaffold region and the outer surface of the fixation region, wherein the two opposite cut-out portions are parallel with the central axis of the scaffold region and the central axis of the fixation region.
  • Embodiment 43 A tissue scaffold comprising: a scaffold region; and an attachment element that encapsulates at least a portion of the scaffold region, wherein the attachment element is configured to engage a tissue and hold the tissue scaffold in place.
  • Embodiment 44 The tissue scaffold of embodiment 43, wherein the attachment element is a density that is greater than a density of the scaffold region.
  • Embodiment 45 The tissue scaffold of embodiment 43 or 44, wherein the attachment element engages a groove or socket in the tissue.
  • Embodiment 46 The tissue scaffold of embodiment 45, wherein the groove or socket is circular.
  • Embodiment 65 A tissue scaffold comprising: a cylindrical scaffold region, wherein an end of the cylindrical scaffold comprises a recessed portion; and an attachment element.
  • Embodiment 67 The tissue scaffold of embodiment 66, wherein the portion of the tissue has been cut to the shape of the recess.
  • Embodiment 71 A tissue scaffold comprising: a porous region; and a solid threaded element that encapsulates at least a portion of the porous region.
  • Embodiment 75 The tissue scaffold of embodiment 74, wherein the plurality of layers comprises at least one rotational offset between a first layer of the plurality of layers and a second layer of the plurality of layers.
  • Embodiment 76 The tissue scaffold of embodiment 74, wherein the scaffold region comprises a plurality of layer densities.
  • Embodiment 78 The method of embodiment 77, wherein forming further comprises: drilling a guide pin into a bone of a patient; reaming a socket into the bone of the patient; and cutting a groove at a bottom of the socket.
  • Embodiment 82 The method of embodiment 80 or 81, wherein inserting further comprises: compressing the tissue scaffold; inserting the tissue scaffold into the socket; and releasing the tissue scaffold to engage the groove of the socket.
  • Embodiment 84 The method of embodiment 83, wherein the forming further comprises: tapping a thread along the socket.
  • Embodiment 85 The method of embodiment 83 or 84, wherein the forming further comprises drilling a guide pin into a bone of a patient.
  • Embodiment 86 The method of embodiment 85, wherein the tapping is guided by the guide pin.
  • Embodiment 87 The method of embodiment 86, wherein the tissue scaffold comprises at least one cutout slot in the threaded portion.
  • Embodiment 88 The method of embodiment 87, wherein the tissue scaffold is inserted using an insertion tool configured to engage the at least one cutout slot of the tissue scaffold.
  • Embodiment 91 The bone preparation tool of embodiment 90, further comprising a handle portion opposite the hollow and compressible end of the cylindrical shaft.
  • Embodiment 93 The bone preparation tool of any one of embodiments 90-92, wherein the two cutting teeth are configured to cut a groove in a bone of a patient.
  • Embodiment 94 The bone preparation tool of any one of embodiments 90-93, wherein the cannula extends past the end of the cylindrical shaft.
  • Embodiment 95 A scaffold insertion tool, comprising: a cylindrical shaft; an end of the cylindrical shaft comprising a receiving end configured to receive a scaffold implant; and at least two engagement tines running parallel to the length of the cylindrical shaft and each comprising a proximal end, a middle portion, and a distal end, wherein the distal end of the engagement tines are configured to engage at least a portion of the received scaffold implant.
  • Embodiment 96 The scaffold insertion tool of embodiment 95, wherein the engagement tines are configured to release the received scaffold implant when depressed at the middle portion.
  • Embodiment 97 A scaffold insertion tool, comprising: a shaft; an end of the cylindrical shaft comprising a receiving end configured to receive a scaffold implant; and at least two engagement tines running parallel to the length of the cylindrical shaft and each comprising a proximal end, a middle portion, and a distal end, and wherein the engagement tines are configured to release the received scaffold implant when depressed at the middle portion.
  • Embodiment 98 The scaffold insertion tool of embodiment 97, wherein the distal ends of the engagement tines are configured to engage at least a portion of the received scaffold implant.
  • Embodiment 99 A scaffold insertion tool, comprising: a cylindrical shaft; a hollow distal end of the cylindrical shaft configured to receive and hold an inserted scaffold implant; a pushing portion located in the cylindrical shaft, wherein a distal end is configured to be in contact with the inserted scaffold implant; and a button on the external surface of the cylindrical shaft, connected to the pushing portion; wherein the button is configured engage the pushing portion to push the inserted scaffold out of the hollow distal end of the cylindrical shaft.
  • Embodiment 100 The scaffold insertion tool of embodiment 99, wherein the hollow distal end comprises a plurality of cutouts such that the hollow distal end flexes to receive the inserted scaffold implant.
  • Embodiment 101 The scaffold insertion tool of embodiment 99 or 100, wherein the flex of the hollow distal end holds the inserted scaffold implant in place.
  • Embodiment 102 A scaffold insertion tool, comprising: a first lever portion comprising a first distal end, a first middle portion, and a first proximal end, wherein the first distal end comprises a first compression tine; and a second lever portion comprising a second distal end, a second middle portion, and a second proximal end, wherein the second distal end comprises a second compression tine; wherein the first lever portion and second lever portion are pivotally coupled at the first middle portion and the second middle portion, wherein the first compression tine and the second compression tine are configured to engage a portion of a tissue scaffold.
  • Embodiment 103 A guide pin for providing a reference point in a host tissue, comprising: an elongated, cylindrical member featuring a tapered tip for facilitating insertion into the host tissue; and depth indicators along a length to assist a user in determining an appropriate insertion depth.
  • Embodiment 104 The guide pin of embodiment 103, wherein the guide pin is made of a biocompatible material.
  • Embodiment 105 The guide pin of embodiment 103 or 104, wherein the tapered tip is designed to minimize tissue damage during insertion.
  • Embodiment 106 The guide pin of any one of embodiments 103-105, wherein the guide pin is drilled into the host tissue.
  • Embodiment 107 The guide pin of any one of embodiments 103-106, wherein the host tissue comprises a femur bone.
  • Embodiment 108 The guide pin of any one of embodiments 103-107, wherein the guide pin is inserted through an alignment guide.
  • Embodiment 109 The guide pin of any one of embodiments 103-108, wherein the guide pin comprises markings or indicators for a depth measurement.
  • Embodiment 110 The guide pin of any one of embodiments 103-109, wherein the guide pin is configured to establish an orientation of a tissue scaffold.
  • Embodiment 111 The guide pin of any one of embodiments 103-110, wherein the guide pin is designed to be removed after a socket preparation is completed.
  • Embodiment 112 A punch for scoring a host tissue, comprising: a body designed to score the host tissue; and an opening configured to be placed over a guide pin for accurate positioning.
  • Embodiment 113 The punch of embodiment 112, wherein the punch is sized to match dimensions of a host tissue lesion.
  • Embodiment 114 The punch of embodiment 112 or 113, wherein the punch is configured to apply axial pressure while rotating to score the host tissue.
  • Embodiment 115 The punch of any one of embodiments 112-114, wherein the punch is made of a biocompatible material.
  • Embodiment 116 The punch of any one of embodiments 112-115, wherein the punch includes markings or indicators to assist in proper alignment during use.
  • Embodiment 117 A cannulated reamer for preparing a socket in a host tissue, comprising: a hollow, cylindrical body designed to create a socket in the host tissue; and at least one cutting tooth configured to facilitate a reaming process.
  • Embodiment 118 The cannulated reamer of embodiment 117, wherein the reamer comprises a depth stop to prevent over-reaming beyond a predetermined cutting depth.
  • Embodiment 119 The cannulated reamer of embodiment 117 or 118, wherein a hollow inside the reamer allows for a passage of a guide pin during use.
  • Embodiment 120 The cannulated reamer of any one of embodiments 117-119, wherein the reamer is made of a biocompatible material.
  • Embodiment 121 The cannulated reamer of any one of embodiments 117-120, wherein the reamer is configured to create a cylindrical socket that matches dimensions of a tissue scaffold.
  • Embodiment 122 The cannulated reamer of any one of embodiments 117-121, wherein the reamer is designed to be used in conjunction with an alignment guide to ensure accurate positioning during the reaming process.
  • Embodiment 123 An undercut tool for preparing at least one groove in a host tissue, comprising: a cylindrical body featuring two cutting teeth designed to create at least one groove in a socket of the host tissue; and a cannula configured to allow for a placement of a guide pin during use.
  • Embodiment 124 The undercut tool of embodiment 123, wherein each cutting tooth is disposed on an outer end of a first arm and a second arm extending from a vertex of the undercut tool.
  • Embodiment 125 The undercut tool of embodiment 123 or 124, wherein an outer diameter of an end of the undercut tool containing the cutting teeth is larger than the socket of the host tissue, requiring compression to fit into the socket.
  • Embodiment 126 The undercut tool of any one of embodiments 123-125, wherein the undercut tool comprises a compression mechanism that allows a user to compress the two cutting teeth for retraction during placement over the guide pin and into the socket.
  • Embodiment 127 The undercut tool of any one of embodiments 123-126, wherein the cutting teeth extend to prepare the at least one groove in the host tissue upon release, wherein the undercut tool requires a compression to retract the teeth for removal.
  • Embodiment 129 An insertion tool for placing a tissue scaffold in a host tissue, comprising: a gripping instrument to compress the tissue scaffold during insertion; and a tube with a pocket to hold the tissue scaffold during insertion.
  • Embodiment 130 The insertion tool of embodiment 129, wherein the insertion tool comprises two tips for gripping the tissue scaffold.
  • Embodiment 132 The insertion tool of any one of embodiments 129-131, wherein the insertion tool comprises at least four relief flutes that allow the tube to receive the tissue scaffold while applying a clamping force to hold the tissue scaffold.
  • Embodiment 133 The insertion tool of any one of embodiments 129-132, further comprising a release button that retracts the tube.
  • Embodiment 134 The insertion tool of any one of embodiments 129-133, wherein the insertion tool is made of a biocompatible material.
  • Embodiment 135 The insertion tool of any one of embodiments 129-134, wherein the insertion tool is designed to provide tactile feedback to a user during the insertion process.
  • Embodiment 136 The insertion tool of any one of embodiments 129-135, wherein the pocket is cylindrical.
  • Embodiment 137 The insertion tool of any one of embodiments 129-136, wherein the pocket is about 0 mm to about 12 mm deep.
  • Embodiment 138 The insertion tool of any one of embodiments 129-137, wherein the tube holds a top half of the tissue.
  • Embodiment 139 A surgical tool kit for installing a tissue scaffold, the surgical tool kit comprising: an alignment guide for ensuring proper positioning of surgical tools; a guide pin for providing a reference point in a host tissue; a punch for scoring the host tissue; a cannulated reamer for preparing a socket in the host tissue; a trial implant for evaluating the prepared socket in the host tissue; an undercut tool for preparing at least one groove in the host tissue; and an insertion tool for placing the tissue scaffold in the host tissue.
  • Embodiment 140 The surgical tool kitof embodiment 139, wherein the surgical tool kit is made of a biocompatible material.
  • Embodiment 141 The surgical tool kitof embodiment 139 or 140, wherein the host tissue comprises a femur bone.
  • Embodiment 142 The surgical tool kitof any one of embodiments 139-141, wherein the alignment guide is a cylindrical tube with both ends open, positioned perpendicular to a lesion in the host tissue to ensure accurate alignment of the surgical tools during the installation of the tissue scaffold.
  • Embodiment 143 The surgical tool kitof any one of embodiments 139-142, wherein the guide pin is drilled into the host tissue.
  • Embodiment 144 The surgical tool kitof any one of embodiments 139-143, wherein the guide pin is an elongated, cylindrical member, featuring a tapered tip for facilitating insertion into the host tissue, and includes depth indicators along its length to assist a user in determining an appropriate insertion depth.
  • the guide pin is an elongated, cylindrical member, featuring a tapered tip for facilitating insertion into the host tissue, and includes depth indicators along its length to assist a user in determining an appropriate insertion depth.
  • Embodiment 146 The surgical tool kit of any one of embodiments 139-145, wherein the cannulated reamer is a hollow, cylindrical tool with at least one cutting tooth designed for creating the socket of varying diameters in the host tissue, and includes a depth stop to prevent over-reaming over at least one predetermined cutting depth.
  • the cannulated reamer is a hollow, cylindrical tool with at least one cutting tooth designed for creating the socket of varying diameters in the host tissue, and includes a depth stop to prevent over-reaming over at least one predetermined cutting depth.
  • Embodiment 148 The surgical tool kit of embodiment 147, wherein the trial implant has a Imm-mark on an outer surface of the trial implant, wherein the Imm-markis visible to the user for evaluating the fit and alignment of the trial implant within the prepared socket in the host tissue.
  • Embodiment 149 The surgical tool kit of any one of embodiments 139-148, wherein the undercut tool is a cylindrical instrument featuring two cutting teeth and a cannula, designed to prepare a groove in the socket of the host tissue, wherein the undercut tool is configured to be placed concentrically over the guide pin.
  • the undercut tool is a cylindrical instrument featuring two cutting teeth and a cannula, designed to prepare a groove in the socket of the host tissue, wherein the undercut tool is configured to be placed concentrically over the guide pin.
  • Embodiment 150 The surgical tool kit of any one of embodiments 139-149, wherein each cutting tooth of the two cutting teeth is disposed on an outer end of a first arm and second arm extending from a vertex of the undercut tool.
  • Embodiment 153 The surgical tool kit of any one of embodiments 139-152, wherein the insertion tool is a gripping instrument that functions similarly to needle nose pliers, designed to compress the tissue scaffold during insertion.
  • Embodiment 155 The surgical tool kit of any one of embodiments 139-154, wherein the tissue scaffold comprises at least one solid snap ring designed for secure fixation of the tissue scaffold on the host tissue.
  • Embodiment 160 The surgical tool kit of any one of embodiments 139-159, further comprising an implant tap that feature cutting threads, is cannulated to fit over the guide pin, and comprises at least six flutes designed to trap bone removed by the cutting threads during a threading process.
  • Embodiment 162 The surgical tool kit of any one of embodiments 139-161, wherein the host tissue comprises bones, cartilages, or other tissues.
  • Embodiment 163 The surgical tool kit of any one of embodiments 139-162, wherein the tissue scaffold comprises at least one thread designed for secure fixation of the tissue scaffold on the host tissue.
  • Embodiment 164 The surgical tool kit of any one of embodiments 139-163, wherein the surgical tool kit is sterilized before use.
  • Embodiment 165 The surgical tool kit of any one of embodiments 139-164, wherein the surgical tool kit is sterilized by steam autoclaving.
  • Embodiment 167 The surgical tool kit of any one of embodiments 139-166, wherein the tissue scaffold is sterilized by steam autoclaving.
  • Embodiment 168 The surgical tool kit of any one of embodiments 139-167, wherein the installation of the tissue scaffold is conducted within about 2 hours post sterilization.
  • Embodiment 171 The surgical tool kit of embodiment 170, wherein the container is made of glass, polymer, or metal.
  • Embodiment 172 The surgical tool kit of embodiment 170 or 171, wherein the container is filled with an aqueous solution.
  • Embodiment 173 The surgical tool kit of any one of embodiments 139-172, wherein the surgical tool kit is organized and fixed in place within a metal container.
  • Embodiment 181 The method of any one of embodiments 176-180, wherein the alignment guide is positioned to fully cover the host tissue.
  • Embodiment 187 The method of any one of embodiments 176-186, further comprising selecting the punch from a plurality of predefined-size punches to score the host tissue.
  • Embodiment 194 The method of any one of embodiments 176-193, further comprising employing the undercut tool to prepare at least one groove in the host tissue to enhance the fixation of the tissue scaffold.
  • a surgeon may first try to mitigate existing damage by removing diseased cartilage, performing microfracture surgery, or regrafting and transplanting healthy cartilage, or combinations thereof.
  • the next step may be an osteochondral autograft (for example, OATS) or the implantation of a device made from processed cadaver tissue.
  • the last line of treatment may be a living tissue transplant from a donor, or the use of a premium implant, for example a premium implant composed of live cells or preserved tissue. If no treatment has long term success, the patient must then wait until they are a candidate for a metallic joint replacement. This can occur when the patient is at least 55 years old, or if pain and mobility loss are so severe that the patient cannot walk.
  • a tissue scaffold improves clinical outcomes for patients suffering from large focal cartilage lesions in the knee.
  • the tissue scaffold may utilize a more mechanically and biologically stable implant, while also addressing manufacturing costs.
  • a tissue scaffold was tested in a 4-month in vivo study. The tissue scaffold has been evaluated in a series of in vitro studies, a small animal osteochondral model, and a large animal chondral defect model in a goat study consisting of 12 total experimental groups. The goat study revealed initial implantation of the device and demonstrated that the tissue scaffold geometry was highly flexible and could be formed into place by a surgeon. This illustrated the flexibility of the tissue scaffold device in not requiring a high degree of customization.
  • FIGS. 26A-26F summarize the histologically observed effects of 3D printed nTP.
  • the top row shows the three animals which received a solid nTP implant and microfracture control.
  • the bottom row shows the three animals that received a 3D printed implant.
  • the microfracture control showed little to no tissue repair activity, and mostly open defects.
  • the 3D printed implants showed the most complete filling of the defect, chondrocyte recruitment int the nTP material, and chondrogenic activity.
  • FIG. 27 illustrates H&E staining of cartilage and nTP samples taken from goat medial femoral condyle implantation sites after 4 months, (a-b) Nuvo cartilage characterized by chondrocyte clusters and new tissue at defect cite, (c-d) Chondrocytes growing on implant material.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Surgery (AREA)
  • Cardiology (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Biophysics (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne des procédés et des dispositifs pour l'implantation d'échafaudages tissulaires pour réparer des défauts ostéochondraux. Les échafaudages tissulaires selon l'invention comprennent des éléments d'attachement ou de fixation qui permettent aux échafaudages tissulaires d'être implantés dans un tissu hôte sans recours à un adhésif.
PCT/US2025/015462 2024-02-13 2025-02-12 Échafaudages tissulaires fixés de manière non adhésive Pending WO2025174792A1 (fr)

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US63/716,611 2024-11-05

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PCT/US2025/015517 Pending WO2025174829A1 (fr) 2024-02-13 2025-02-12 Outils chirurgicaux pour l'implantation d'un échafaudage tissulaire

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US20080039954A1 (en) * 2006-08-08 2008-02-14 Howmedica Osteonics Corp. Expandable cartilage implant
US20100049322A1 (en) * 2008-08-19 2010-02-25 Warsaw Orthopedic, Inc. Osteochondral repair implants and methods
US20100168856A1 (en) * 2008-12-31 2010-07-01 Howmedica Osteonics Corp. Multiple piece tissue void filler
US20140324169A1 (en) * 2013-04-26 2014-10-30 New York Society For The Ruptured And Crippled Maintaining The Hospital For Special Surgery Multi-component non-biodegradable implant, a method of making and a method of implantation

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