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US 10,238,773 B2Granted
Methods of making collagen fiber medical constructs and related medical constructs, including nerve guides and patches
AssigneeMiMedx Group, Inc.
InventorsMengyan Li, Thomas J. Koob
Life of this patent
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Abstract
The disclosure describes methods of winding collagen fiber to make medical constructs and related collagen fiber tube and patch devices.
Claims33
A method of manufacturing a medical construct, comprising:
- winding at least one collagen fiber a number of revolutions about a length of a support member having a long axis, the winding having at least one defined pitch and/or fiber angle relative to the long axis of the support member to form the construct, wherein the winding comprises winding a continuous length of the at least one collagen fiber at a first pitch on a first layer and continuing winding of the at least one collagen fiber at a second smaller or greater pitch on a second layer over the first layer;
- and
- placing a gel comprising soluble collagen onto the at least one collagen fiber during, after or during and after the winding step so that an outer surface thereof comprises a collagen film when the soluble collagen is dry, wherein the collagen film comprises collagen fibers, fibrils and/or microfibrils.
A method of manufacturing a medical construct, comprising:
- winding at least one collagen fiber a number of revolutions about a length of a support member having a long axis and successively in first and second opposing directions to form overlapping layers of the at least one collagen fiber, the winding having at least one defined pitch and/or fiber angle relative to the long axis of the support member along the first direction corresponding to a first layer and a different at least one defined pitch and/or fiber angle relative to the long axis of the support member along the second opposing direction corresponding to a second layer to form the construct, wherein the winding in the first and second opposing directions forms a series of a plurality of intersecting circumferentially spaced apart segments of the overlying layers of the at least one collagen fiber;
- and
- providing a spooled supply of a continuous length of the at least one collagen fiber that is between about 1 m to about 100 m for the winding step.
A method of manufacturing a medical construct, comprising:
- placing a collagen gel about an outer surface of a support member;
- and
- allowing the collagen gel to dry to form a film on the support member;
- then
- winding the at least one collagen fiber about the support member over the film while applying a liquid and/or gel of soluble collagen to a surface of the at least one collagen fiber on the support member, wherein the winding the least one collagen fiber comprises winding the at least one collagen fiber a number of revolutions about a length of the support member having a long axis, the winding having at least one defined pitch and/or fiber angle relative to the long axis of the support member to form the construct, wherein the winding comprises winding a continuous length of the at least one collagen fiber at a first pitch on a first layer and winding the at least one collagen fiber at a second smaller or greater pitch on a second layer over the first layer;
- then
- allowing the wound collagen fiber with the soluble collagen to dry;
- and then
- applying a collagen gel over the dried collagen fiber with the soluble collagen and allowing the applied collagen gel to dry to form an outer layer of film.
6 more elements
A method of manufacturing a medical construct, comprising:
- winding at least one collagen fiber a number of revolutions about a length of a support member having a long axis, the winding having at least one defined pitch and/or fiber angle relative to the long axis of the support member to form the construct, wherein the winding comprises winding a continuous length of the at least one collagen fiber at a first pitch on a first layer and continuing winding the at least one collagen fiber at a second smaller or greater pitch on a second layer over the first layer, and wherein the winding further comprises winding the at least one collagen fiber in a plurality of axially spaced apart segments with increased collagen fiber density, at least some of which are provided as reinforced segments for suturing.
A method of manufacturing a medical construct, comprising:
- winding at least one collagen fiber a number of revolutions about a length of a support member having a long axis in a plurality of overlying layers, the winding having at least one defined pitch and/or fiber angle relative to the long axis of the support member to form the construct with the overlying layers providing a series of a plurality of intersecting circumferentially spaced apart segments of the at least one collagen fiber, wherein each intersecting segment of a respective series resides adjacent a respective longitudinal position of the construct,
- wherein the construct is a nerve cuff, and wherein the at least one collagen fiber is a single collagen fiber that is wound in a first axial direction relative to the support member for a length of the construct then wound in a second opposing axial direction relative to the support member for a length of the construct to provide the overlying layers thereby providing an anti-fray configuration for the nerve cuff.
A method of manufacturing a medical construct, comprising:
- winding at least one collagen fiber a number of revolutions about a length of a support member having a long axis, the winding having at least one defined pitch and/or fiber angle relative to the long axis of the support member to form the construct,
- wherein the construct is a tube and the at least one collagen fiber is a single fiber that is wound in a first axial direction for a length of the tube, then wound in a second opposing axial direction for a length of the tube to form multiple overlying layers of the single collagen fiber forming a fiber mesh pattern with interstitial spaces, and wherein a collagen film resides on at least one of the inner and outer surfaces of the construct and defines a smooth surface.
A method of manufacturing a medical construct, comprising:
- winding at least one collagen fiber a number of revolutions about a length of a support member having a long axis, the winding having at least one defined pitch and/or fiber angle relative to the long axis of the support member to form the construct;
- placing a liquid or gel comprising soluble collagen onto the at least one wound collagen fiber during or after the winding step so that the construct is wetted and/or so that the outer surface is covered in a collagen film when the soluble collagen is dry,
- wherein the soluble collagen is an extruded gel of soluble collagen having a collagen concentration of between about 0.1% to about 4% weight per volume, and wherein a collagen fiber of the at least one collagen fiber (dry) has a diameter of between about 0.05 mm to about 0.2 mm (average).
A method of manufacturing a medical construct, comprising:
- winding at least one collagen fiber a number of revolutions about a length of a support member having a long axis, the winding having at least one defined pitch and/or fiber angle relative to the long axis of the support member to form the construct;
- and
- removing the support member after cross-linking the at least one collagen fiber while the wound at least one collagen fiber is held on the support member.
A method of manufacturing a medical construct, comprising:
- winding at least one collagen fiber a number of revolutions about a length of a support member having a long axis, the winding having at least one defined pitch and/or fiber angle relative to the long axis of the support member to form the construct,
- wherein the construct is a nerve guide, and wherein the nerve guide has sufficient strength and elasticity to, in use, withstand buckling and to be able to bend and to elastically return to its original shape after bending to inhibit occlusive pressures or restrictions on a nerve.
Dependencies are inferred from the claim text.