Patent Grant
11717411
This disclosure relates generally to implants, and, more specifically, to hydrogel joint implants and various tools, devices, systems, and methods related thereto.
Implants can be used to replace deteriorated or otherwise damaged cartilage within a joint. Such devices can be used to treat osteoarthritis, rheumatoid arthritis, other inflammatory diseases, generalized joint pain, joints damaged in an accident, while damaged participating in athletics, joints damaged due to repetitive use, and/or other joint diseases.
In some embodiments, an implant configured for implantation in a joint comprises, or alternatively consists essentially of, a first portion, a second portion, and a third portion. The first portion comprises a hydrogel. The second portion comprises a porous material (e.g., ceramic, metal, plastic) and the hydrogel in pores of the porous material. The third portion comprises the porous material. The second portion is between the first portion and the second portion. The first portion is free or substantially free of the porous material. The third portion is free or substantially free of the hydrogel.
The hydrogel may comprise polyvinyl alcohol (PVA). The hydrogel may comprise water. The hydrogel may comprise saline. The porous material may comprise an oxide material. The porous material may comprise at least one of aluminum, alumina, zirconia, titanium, titania, stainless steel, PEEK, and steatite. The porous material may have a porosity between 45 ppi and 80 ppi. Pores of the porous material may have a dimension between 100 μm and 500 μm. The first portion may comprise a contoured surface. The first portion may comprise an annular flange. The third portion may comprise threads. The implant may be load bearing and non-biodegradable. The implant may be configured to be placed in at least one of a toe, finger, ankle, knee, shoulder, hip, or other joint. A lateral dimension of the first portion may be between 6 mm and 10 mm. A lateral dimension of the first portion may be between 5% and 15% larger than a lateral dimension of the third portion. A ratio of a lateral dimension of the first portion to a lateral dimension of the third portion may be between 1.05 and 1.3.
In some embodiments, a method of treatment comprises, or alternatively consists essentially of, aligning an implant deployment tool with a recess in a bone, the recess comprising an opening facing a joint, and deploying the implant out of the implant deployment tool, through the opening, and at least partially in the recess.
After deployment, the implant may be 1 mm to 3 mm proud. The method may further comprise radially compressing the first portion of the implant in the implant deployment tool. The method may further comprise forming the recess. Forming the recess may comprise using a drill bit. Deploying the implant may comprise urging the implant through an interior of the implant deployment tool using a plunger. Deploying the implant may be manual. Deploying the implant may be mechanically assisted. Deploying the implant may comprise screwing the implant into the recess.
In some embodiments, a method of manufacturing the implant comprises, or alternatively consists essentially of, positioning hydrogel material in a well of a mold, positioning porous material in an upper portion of the well and protruding from the well, and freezing and thawing the hydrogel material at least once.
Positioning the porous material may comprise anchoring the porous material.
In some embodiments, a method of manufacturing the implant comprises, or alternatively consists essentially of, aligning a well of a second mold portion with a well of a first mold portion, the well of the first mold portion comprising a porous material, positioning hydrogel material in the well of the second mold portion and partially in the well of the first mold portion, and freezing and thawing the hydrogel material at least once.
The method may further comprise positioning the porous material in the well of the first mold portion. Positioning the hydrogel material may be through a closable port, and further comprising closing the closable port. The method may comprising forming flash between the first mold portion and the second mold portion. The method may further comprise removing the flash. The porous material may comprise a disc shape.
In some embodiments, an implant system configured for implantation in a joint comprises, or alternatively consists essentially of, a first part and a second part. The first part comprises an implant. The implant comprises, or alternatively consists essentially of, a first portion comprising a hydrogel, a second portion comprising a porous material and the hydrogel in pores of the porous material, and a third portion comprising the porous material. The first portion is free of or lacks the porous material. The third portion is free of or lacks the hydrogel. The second part comprises sidewalls, a bottom, a cavity at least partially defined by the sidewalls and the bottom, and an anchoring element. The cavity is configured to at least partially receive the implant. One of the porous material and the sidewalls of the second part comprises a detent and the other of the porous material and the sidewalls of the second part comprises a groove configured to interact with the detent when the implant is at least partially in the cavity of the second part.
The porous material may comprise a toroidal shape. The porous material may comprise a detent extending radially inward. The anchoring element may selected from the group consisting of a barb, and anchor, and a hole in the bottom of the second part and a screw configured to extend through the hole in the bottom of the second part. The anchor may comprise an insert, a finger extending radially outwardly and towards a top of the implant system, a wire threaded through holes in the bottom of the second part, and a knot configured to be tightened upon pulling of ends of the wire.
In some embodiments, an implant system configured for implantation in a joint comprises, or alternatively consists essentially of, a first part and a second part. The first part comprises an implant comprising a first portion comprising a hydrogel, a second portion comprising a porous material and the hydrogel in pores of the porous material, and a third portion comprising the porous material. The first portion is free of or lacks the porous material. The third portion is free of or lacks the hydrogel. The second part comprises sidewalls, a bottom, and a cavity at least partially defined by the sidewalls and the bottom. The cavity is configured to at least partially receive the implant.
One of the porous material and the sidewalls of the second part may comprise a detent and the other of the porous material and the sidewalls of the second part may comprise a groove configured to interact with the detent when the implant is at least partially in the cavity of the second part. The second part may further comprise an anchoring element. The anchoring element may comprise a barb. The anchoring element may comprise an anchor comprising an insert, a finger extending radially outwardly and towards a top of the implant system, a wire threaded through holes in the bottom of the second part, and a knot configured to be tightened upon pulling of ends of the wire. The ends of the wire may form a loop. The anchoring element may comprise a hole in the bottom of the second part and a screw configured to extend through the hole in the bottom of the second part. The anchoring element may comprise a hole in the sidewalls of the second part and a second screw configured to extend through the hole in the sidewalls of the second part.
In some embodiments, an implant system configured for implantation in a joint comprises a first portion comprising a hydrogel, a second portion comprising a porous material and the hydrogel in pores of the porous material, and a third portion comprising the porous material. The first portion is free of or lacks the porous material. The third portion is free of or lacks the hydrogel. The third portion is configured to contact bone. Pores of the porous material are configured to allow bone infiltration.
The first portion may comprise a contoured surface. The contoured surface may be customized for a particular subject based on scan data. The scan data may comprise at least one of computerized tomography, computerized axial tomography, positron emission tomography, and magnetic resonance imaging. The porous material may comprise at least one of aluminum, titanium, and stainless steel. The porous material may comprise titanium mesh. The porous material may comprise printed titanium. The porous material may comprise at least one of alumina, zirconia, titania, and steatite. The porous material may comprise PEEK. The porous material may have a porosity between 45 ppi and 80 ppi. Pores of the porous material may have a dimension between 100 μm and 500 μm. The first portion may comprise a hemispherical shape. The first portion may comprise a wedge shape.
In some embodiments, an implant system configured for implantation in a joint comprises an implant comprising a first portion comprising a hydrogel, a second portion comprising a porous material and the hydrogel in pores of the porous material, and a third portion comprising the porous material. The first portion is free of or lacks the porous material. The third portion is free of or lacks the hydrogel.
The second portion may be between the first portion and the second portion. The hydrogel may comprise polyvinyl alcohol (PVA). The hydrogel may comprise water. The hydrogel may comprise saline. The porous material may comprise an oxide ceramic. The porous material may comprise at least one of aluminum, titanium, and stainless steel. The porous material may comprise titanium mesh. The porous material may comprise printed titanium. The porous material may comprise PEEK. The porous material may comprise at least one of alumina, zirconia, titania, and steatite. The porous material may have a porosity between 45 ppi and 80 ppi. Pores of the porous material may have a dimension between 100 μm and 500 μm. The first portion may comprise an annular flange. The third portion may comprise threads.
The first portion may comprise a contoured surface. The contoured surface may be customized for a particular subject based on scan data. The scan data may comprise at least one of computerized tomography, computerized axial tomography, positron emission tomography, and magnetic resonance imaging.
The first portion may comprise a hemispherical shape. The second portion may comprise a hemispherical shape. The third portion may comprise a cylindrical shape. The first portion may comprise a wedge shape. The third portion may comprise a wedge shape. The porous material may comprise a disc shape. The porous material may comprise a toroidal shape. The porous material may comprise a detent extending radially inward. The porous material may comprise an aperture through a sidewall of the porous material. The hydrogel may at least partially extend through the aperture. The porous material may comprise a finger extending radially outwardly and towards a top of the implant system. The porous material may comprise a barb.
The implant may be load bearing. The implant may be non-biodegradable. The implant system may be configured to be placed in at least one of a toe, finger, ankle, knee, shoulder, hip, or other joint. A lateral dimension of the first portion may be between 6 mm and 10 mm. A lateral dimension of the first portion may be between 5% and 15% larger than a lateral dimension of the third portion. A ratio of a lateral dimension of the first portion to a lateral dimension of the third portion may be between 1.05 and 1.3.
The implant system may further comprise a second part comprising sidewalls, a bottom, and a cavity at least partially defined by the sidewalls and the bottom. The cavity may be configured to at least partially receive the implant. The porous material may comprise a groove extending radially inward and the second part may comprise a detent extending radially inward from the sidewalls of the second part. The detent may be configured to interact with the groove when the implant is at least partially in the cavity of the second part. The porous material may comprise a detent extending radially outward and the second part may comprise a groove extending radially outward into the sidewalls of the second part. The detent may be configured to interact with the groove when the implant is at least partially in the cavity of the second part.
The second part further may comprise an anchoring element. The anchoring element may comprise a barb. The barb may comprise a plurality of barbs. The plurality of barbs may be vertically stacked. The anchoring element may comprise an anchor comprising an insert, a finger extending radially outwardly and towards a top of the implant system, a wire threaded through holes in the bottom of the second part, and a knot configured to be tightened upon pulling of ends of the wire. The ends of the wire may form a loop. The anchoring element may comprise a hole in the bottom of the second part and a screw configured to extend through the hole in the bottom of the second part. The anchoring element may comprises a plurality of holes in the bottom of the second part and a plurality of screws configured to extend through the plurality of holes in the bottom of the second part. The anchoring element may comprise a hole in the sidewalls of the second part and a second screw configured to extend through the hole in the sidewalls of the second part. The anchoring element may comprise a plurality of holes in the sidewalls of the second part and a plurality of second screws configured to extend through the plurality of holes in the sidewalls of the second part.
In some embodiments, a method of treatment comprises, or alternatively consists essentially of, aligning an implant deployment tool with a recess in a bone and deploying the implant out of the implant deployment tool, through the opening, and at least partially in the recess. The recess comprises an opening facing a joint.
After deployment, the implant may be 1 mm to 3 mm proud. The method may further comprise radially compressing the first portion of the implant in the implant deployment tool. The method may further comprise forming the recess. Forming the recess may comprise using a drill bit. Deploying the implant may comprise urging the implant through an interior of the implant deployment tool using a plunger. Deploying the implant may be manual. Deploying the implant may be mechanically assisted. Deploying the implant may comprise screwing the implant into the recess.
In some embodiments, a method of manufacturing the implant comprises positioning hydrogel material in a well of a mold, positioning porous material in an upper portion of the well and protruding from the well, and freezing and thawing the hydrogel material at least once. Positioning the porous material may comprise anchoring the porous material.
In some embodiments, a method of manufacturing the implant comprises aligning a well of a second mold portion with a well of a first mold portion. The well of the first mold portion comprises a porous material. The method further comprises positioning hydrogel material in the well of the second mold portion and partially in the well of the first mold portion and freezing and thawing the hydrogel material at least once. The method may further comprising positioning the porous material in the well of the first mold portion. Positioning the hydrogel material may be through a closable port. The method may further comprise closing the closable port.
The method may comprising forming flash between the first mold portion and the second mold portion. The method may further comprise removing the flash. The porous material may comprises a disc shape. The porous material may comprises a toroidal shape.
Certain features, aspects, and advantages of the disclosure are described with reference to drawings, which are intended to illustrate, but not to limit, the various inventions disclosed herein. It is to be understood that the attached drawings are for the purpose of illustrating concepts and embodiments of the disclosure and may not be to scale.
The discussion and the figures illustrated and referenced herein describe various embodiments of a cartilage implant, as well as various tools, systems, and methods related thereto. A number of these devices and associated treatment methods are particularly well suited to replace deteriorated or otherwise damaged cartilage within a joint. Such implants are configured to remain within the patient's joint on a long-term basis (e.g., for most or all of the life of the patient or subject), and as such, are configured, in some embodiments, to replace native cartilage. In some embodiments, an implant is configured to be substantially non-biodegradable and/or non-erodable. In some embodiments, an implant is configured to remain within the patient's joint or other portion of the anatomy for a minimum of 10 to 100 years (e.g., about 10 years, about 20 years, about 25 years, about 30 years, about 35 years, about 40 years, about 45 years, about 50 years, about 55 years, about 60 years, about 65 years, about 70 years, about 75 years, about 80 years, about 85 years, about 90 years, about 95 years, about 100 years, duration ranges between the foregoing values, etc.) without losing structural and/or physical properties and/or without losing ability to function as a cartilage replacement component or device. In some embodiments, an implant is configured to remain within the anatomy for greater than 100 years without losing structural and/or physical properties and/or without losing ability to function as a cartilage replacement component. Certain implants described herein can be used to treat osteoarthritis, rheumatoid arthritis, other inflammatory diseases, generalized joint pain, joints damaged in an accident, joints damaged while participating in athletics, joints damaged due to repetitive use, and/or other joint diseases. However, the various devices, systems, methods, and other features of the embodiments disclosed herein may be utilized or applied to other types of apparatuses, systems, procedures, and/or methods, including arrangements that have non-medical benefits or applications.
Certain embodiments described herein may be advantageous because they include one, several, or all of the following benefits: (i) improved osseointegration compared to implants having a hydrogel surface; (ii) improved coupling of disparate implant materials; (iii) improved cavity wall apposition compared to substantially cylindrical implants; (iv) reduced implant height; (v) reduced depth of a bone cavity configured to receive an implant; (vi) improved structural stability; and/or (vii) increased manufacturing flexibility.
The first portion 102 and the second portion 104 of the implant 100 can comprise one or more other materials, either in addition to or in lieu of PVA, such as, for example, other hydrogels, other polymeric materials, additives, and/or the like. As discussed herein, the second portion 104 comprises porous material. In some embodiments, the PVA content of a hydrogel is about 40% by weight. The PVA content of hydrogel in an implant 100 can be less than or more than about 40% by weight (e.g., about 10%, about 15%, about 20%, about 25%, about 30%, about 32%, about 34%, about 36%, about 37%, about 38%, about 39%, about 41%, about 42%, about 43%, about 44%, about 46%, about 48%, about 50%, about 55%, about 60%, about 65%, about 70%, less than about 10%, more than about 70%, ranges between such values, etc.), as desired or required.
The hydrogel of the implant 100, as well as other implants disclosed herein, can comprise water, saline, other liquids, combinations thereof, and/or the like. In some embodiments, saline may be preferred over water, because, under certain circumstances, saline can help maintain osmotic balance with surrounding anatomical tissues following implantation. The exact composition of hydrogel in an implant 100 (e.g., PVA or other hydrogel materials, water, saline or other liquids, other additives, etc.) can be selected so as to provide the implant 100 with the desired or required strength, load bearing capacity, compressibility, flexibility, longevity, durability, resilience, coefficient of friction, and/or other properties and characteristics. Thus, in some embodiments, any hydrogel portion of the implants disclosed herein consist essentially of saline and PVA. In some embodiments, such hydrogel portions of the implants do not comprise any additional additives (e.g., growth factors, surface or other coatings, etc.). In addition, according to some embodiments, the hydrogel portions of any of the implant configurations disclosed herein comprises a consistent concentration (e.g., no concentration gradients), density and/or other chemical and/or physical properties throughout.
In some embodiments, the implant 100, as well as other implants disclosed herein, is configured for drug delivery and/or is seeded with growth factors and/or cells. In some embodiments, the implant 100 comprises one or more of the following: chondrocytes, growth factors, bone morphogenetic proteins, collagen, hyaluronic acid, nucleic acids, and stem cells. Such factors and/or any other materials included in the implant 100 and selectively delivered to an implant site can help facilitate and/or promote the long-term fixation of the implant 100 at the joint or other target area of the anatomy.
In some embodiments, the hydrogel comprises PVA and/or any other polymeric material. In some embodiments, the content of PVA in the hydrogel is between about 35% and about 45% by weight (e.g., about 35%, about 36%, about 37%, about 38%, about 39%, about 40%, about 41%, about 42%, about 43%, about 44%, about 45%, ranges between such values, etc.). In some embodiments, the content of PVA in the hydrogel is greater than about 45% by weight (e.g., about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, greater than about 70%, ranges between such values, etc.) or less than about 35% by weight (e.g., about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, ranges between such values, less than about 5%, etc.). In some embodiments, the content of PVA or other component in the hydrogel is about 40% by weight.
In some embodiments, the implant 100 is load bearing and generally non-biodegradable (e.g., non-bioerodable). In some embodiments, the implant 100 is configured for placement in at least one of a toe, finger, ankle, knee, shoulder, hip, or any other joint. In some embodiments, a transition between the upper surface and the sidewalls is generally curved or otherwise smooth.
In some embodiments, the first portion 102 of the implant may have a lateral dimension (e.g., diameter) between about 6 mm and about 10 mm (e.g., about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, ranges between such values, etc.), as measured in an uncompressed state. Lateral dimensions smaller than about 6 mm (e.g., between about 2 mm and about 6 mm) and larger than about 10 mm (e.g., between about 10 mm and about 14 mm) are also possible for use in subjects with small or large bones, respectively, and/or for use in joints with small or large bones, respectively.
The third portion 106 of the implant can comprise a porous material, such as, for example, a porous ceramic (e.g., oxide-ceramic), metal (e.g., titanium (e.g., titanium mesh, printed titanium), stainless steel (e.g., stainless steel wool)), plastic (e.g., polyaryl ether ketone (PAEK) (e.g., polyether ether ketone (PEEK))), other biocompatible materials, combinations thereof, and the like). The third portion 106 may be free or substantially free from the hydrogel of the first portion 102. In some embodiments, the third portion 106 is substantially rigid or non-deformable. In some embodiments, the third portion 106 is at least partially deformable. The pores and/or other openings of the third portion 106 may promote osseointegration of the implant 100 in a bone. Compared to an implant consisting essentially of hydrogel, an implant comprising one or more porous materials (e.g., porous ceramic, metal, plastic, etc.) may have a reduced height because the porous ceramic and/or other porous material may provide structural stability and/or because the porous ceramic or other porous material may provide better osseointegration such that less contact with bone provides at least as much osseointegration.
The third portion 106 is illustrated in
According to some embodiments, the second portion 104 and the third portion 106 may comprise an oxide ceramic, for example oxide ceramics from CeramTec of Laurens, S.C., as provided in Tables 1 and 2, although other materials and combinations of materials are also possible (e.g., non-oxide ceramics, non-ceramics).
According to some embodiments, the second portion 104 and the third portion 106 may comprise a metal, for example titanium mesh, printed titanium, stainless steel, etc. According to some embodiments, the second portion 104 and the third portion 106 may comprise a plastic, for example PAEK, PEEK, etc.
In some embodiments, the porous material can have a porosity between about 45 pores per inch (ppi) and about 80 ppi (e.g., about 45 ppi, about 50 ppi, about 55 ppi, about 60 ppi, about 65 ppi, about 70 ppi, about 75 ppi, about 80 ppi, ranges between such values, etc.). The pores of the porous material may have a diameter or other dimension between about 100 micrometers (microns; μm) and about 500 μm (e.g., about 100 μm, about 150 μm, about 200 μm, about 250 μm, about 300 μm, about 350 μm, about 400 μm, about 450 μm, about 500 μm, ranges between such values, etc.), as desired or required.
In some embodiments, pores of the porous material in the second portion 104 are different than pores of the porous material in the third portion 106. For example, the pores of the porous material in the second portion 104 may be configured to allow hydrogel infiltration while the pores of the porous material in the third portion 106 may be configured to allow osseointegration. In some embodiments, the porous material in the second portion 104 is different than the porous material in the third portion 106. For example, the porous material in the second portion 104 may comprise a first material having a property and the porous material in the third portion 106 may comprise a second material having a property different than the property of the first material. The property may comprise, for example, the material itself (e.g., whether ceramic, metal, plastic, etc.), porosity, pore size, dimensions, deformability, etc.
Overlap of hydrogel material of the first portion 102 and porous material of the third portion 106 in the second portion 104, for example by the hydrogel material filling pores of the porous material, may securely anchor the first portion 102 to the third portion 106, for example compared to an implant in which a surface of a hydrogel material is adhered to a surface of another material. In some embodiments, a ratio of a height of the second portion 104 to a height of the third portion 106 is between about 1:5 and about 5:1 (e.g., about 1:5, about 1:4, about 1:3, about 1:2, about 1:1, about 2:1, about 3:1, about 4:1, about 5:1, ranges between such values, etc.). In some embodiments, a ratio of a height of the second portion 104 to a height of the ceramic material (e.g., a height of the second portion 104 and a height of the third portion 106) is between about 1:5 and about 1:1.1 (e.g., about 1:5, about 1:4, about 1:3, about 1:2, about 1:1.5, about 1:1.4, about 1:1.3, about 1:1.2, about 1:1.1, ranges between such values, etc.). In some embodiments, a ratio of a height of the third portion 106 to a height of the ceramic material (e.g., a height of the second portion 104 and a height of the third portion 106) is between about 1:5 and about 1:1.1 (e.g., about 1:5, about 1:4, about 1:3, about 1:2, about 1:1.5, about 1:1.4, about 1:1.3, about 1:1.2, about 1:1.1, ranges between such values, etc.).
Compared to an implant consisting essentially of hydrogel, an implant comprising porous material (e.g., porous ceramic, metal, plastic, etc.) may have a reduced height. For example, compared to implants consisting only or essentially of a hydrogel material, such hybrid implants can have a height that is reduced by between about 5% and about 30% (e.g., about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, ranges between the foregoing percentages, etc.). In some embodiments, the third portion 106 of the implant 100 may provide improved or enhanced structural stability to the implant 100. Such improved or enhanced structural stability may be beneficial for use with large bones, although use with small bones is also possible.
Although the implant 100 is schematically illustrated as a cylindrical plug, other shapes of the implant 100 are also possible. For example, an upper surface of the first portion 102 may be contoured to abut particular anatomy (e.g., planar (e.g., flat), non-planar (e.g., curved, concave, convex, undulating, fluted)). The implant 100 can include a generally circular or oval cross-sectional shape. In some embodiments, the implant 100 is generally shaped like a cylinder or a mushroom. The overall shape of any of the implants disclosed herein can vary depending on the specific application or use. For example, the shape of at least part of a portion 102, 104, 106 can be generally polygonal (e.g., rectangular, round, hexagonal), irregular, and/or the like.
A molding process, for example as described herein with respect to
In some embodiments, means for treating a joint (e.g., the implant 100) comprises, or alternatively consists essentially of, means for providing a lubricious surface (e.g., the first portion 102) and means for promoting osseointegration (e.g., the third portion 106).
According to some embodiments, the bone portion 308 in which the implant 300 will be positioned has been drilled to form a hole or aperture or recess or cavity or crater or pit or pocket 310. In some embodiments, the lateral dimension (e.g., diameter) of the hole 310 is less than the lateral dimension (e.g., diameter) of the third portion 306, which is rigid. In some embodiments, a lateral dimension and/or cross-sectional area of the hole 310 is about 5% to about 15% (e.g., about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, about 15%, ranges between such values, etc.) wider or otherwise larger than the lateral dimension and/or cross-sectional area of the third portion 306. The lateral dimension (e.g., diameter) of the hole 310 may be smaller than the lateral dimension (e.g., diameter) of the first portion 302, which may flex radially inwardly. Although illustrated as a cylindrical hole 310, other shapes are also possible (e.g., trapezoidal tapering inwards towards the upper surface). In some embodiments, a lateral dimension and/or cross-sectional area of the hole 310 is about 5% to about 15% (e.g., about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, about 15%, ranges between such values, etc.) narrower or otherwise smaller than the lateral dimension and/or cross-sectional area of the first portion 302. The hole 310 may be coated or otherwise treated prior to positioning of the implant 300.
As a result of the shape of the implant 300 and the corresponding implant site (e.g., in the hole 310), the implant 300 may be inwardly radially compressed in order to insert the implant 300 in the hole 310. A delivery system or introducer 312 and/or other delivery tools can be used to facilitate positioning of the implant 300. Radially inward compressive forces may facilitate delivery of an implant 300 that is at least partially radially oversized relative to the hole 310, as discussed further herein. The degree to which the implant 300 can be compressed (e.g., circumferentially, radially inwardly, etc.) may depend on one or more factors, properties, characteristics and/or other considerations of the first portion 302, such as, for example, implant size, water content, ingredients and other components, strength, elasticity, surrounding temperature, method of manufacturing, and/or the like. Although described herein as generally rigid, the second portion 304 and the third portion 306 may also have some degree of compressibility. Radial compression of an implant 300 can affect the overall height, the shape and/or contours of outer surfaces (e.g., top or articulating surface, base or bottom surface, sides, etc.), and/or one or more other properties or characteristics of the implant 300. In some embodiments, radial compression of an implant 300 causes the height of the implant 300 to increase (e.g., relative to the height of the implant 300 when not radially compressed). Consequently, careful consideration may be given to the design of the implant 300 based on, among other things, the expected level of radial compression that may occur once the implant 300 has been properly secured in the hole 310, prior to implantation. Otherwise, in some embodiments, upon implantation, an implant 300 may not properly align with adjacent cartilage or other tissue surfaces in a joint or other anatomical location.
According to some embodiments, the implant 300 is loaded into a delivery system 312; only the distal end of the delivery system 312 is illustrated in
The first portion 302 may have a larger lateral dimension (e.g., diameter) than the third portion 306 to create a “mushroom” shape, as illustrated in
The smaller third portion 306 can slide into the hole 310 of the bone portion 308, although preferably making contact with the sidewalls or perimeter of the hole 310, and the larger first portion 302 can be wedged into the hole 310 of the bone portion 308 due to its flexibility. Referring again to
As shown in
As shown in
The first mold portion 508 and the second mold portion 512 meet at intersection 518. Similar to blow molding processes, any spacing between the mold portions 508, 512 may result in flashing. The molds 508, 512 may be configured to reduce or minimize flashing, for example by being precisely corresponding, tightly joined, etc. The molds 508, 512 may be configured to not reduce flashing, for example by using a flash removal process or by allowing the implants 500 to have flashing.
One or more of the mold portions described with respect to
In some embodiments, a scan may reveal that a plurality of implants may be used for treatment. For example, compared to one implant, a plurality of implants may be better able to treat a large defect, be better provide a load bearing surface to key points, and/or provide better access to a physician. The scan can be used to select locations and/or sizes for a plurality of implants. For example, taking a knee joint as an example, a user may select in a scan a portion of a lateral condyle for a first implant and a portion of a medial condyle for a second implant. If the implant would provide an advantage if the portion is a little more anterior, a little more posterior, a little more medial, a little more lateral, etc., the implant can be customized to that particular location using the scan, which may result in, for example, different load bearing surface features, different dimensions, different protrusion amounts, combinations thereof, and the like.
Any of the implant embodiments disclosed herein, or equivalents thereof, can be manufactured using freeze/thaw cycling and/or any other appropriate production method. For example, a hydrogel formulation comprising water, saline, PVA (and/or other hydrogel materials), other polymeric materials, other additives and/or the like can be cooled, heated, and/or otherwise treated as part of a freeze/thaw manufacturing process. In some embodiments, a hydrogel solution comprising saline and about 40% PVA by weight is heated to approximately 121° C. under elevated pressure conditions (e.g., to effect dissolution of the polymer). For example, such a solution can be autoclaved to facilitate complete or substantially complete dissolution of the PVA in the saline, water, and/or other liquid. Next, the temperature and/or pressure of the solution can be lowered to permit entrapped air and/or other gases to escape. In some embodiments, after the autoclaving or similar step, the solution is generally maintained at a temperature of approximately 95° C. and atmospheric pressure for a predetermined time period. The solution can then be transferred (e.g., pumped, poured, etc.) into a mold or mold portions (e.g., as described with respect to
The molded implant can be removed either after initial formation or after undergoing additional treatment (e.g., freeze/thaw cycling, other heat and/or pressure treatment, etc.). The molded implant may optionally be cut, altered, or otherwise processed after molding. In some embodiments, flashing may be excised and discarded as part of a subsequent reshaping step.
In some embodiments, due in part to the remaining production steps, accommodation of any changes in size (e.g., expansion, contraction, etc.) that may occur or are likely to occur to the implant can be considered during manufacturing by properly sizing and otherwise designing the mold or mold portions. The amount of contraction or expansion of the implant can be based on one or more factors or conditions, such as, for example, the number of freeze/thaw cycles, the temperature and/or pressure ranges associated with the remaining steps, and/or the like.
Other methods can also be used to form the implants described herein. For example, an implant can be formed, at least in part, using an injection molding process and/or any other molding or casting procedure. In such injection or transfer molding techniques, once the hydrogel or other implant solution has been prepared, it can be loaded into an injection cylinder or other container of a molding press. The solution can then be forcibly transferred into a closed mold assembly using a pneumatic or hydraulic ram or any other electromechanical device, system, or method. In some embodiments, the hydrogel and/or other solution or implant component is injected into a corresponding closed mold assembly through a standard runner and gate system. Injection molding of implants can provide one or more benefits relative to open mold assemblies. For instance, an implant formed as part of an injection molding technique may be or may essentially be in a final shape immediately after the injection molding step has been completed such that the manufacturing process may be free or may be substantially free of steps such as post-mold cutting, reshaping, resizing, and/or processing.
Regardless of how the implant is molded or otherwise shaped or manufactured, the implant can be subsequently subjected to one or more freeze/thaw cycles, as desired or required. In some embodiments, the implant, while in a cavity of a mold, is cooled using a total of four freeze/thaw cycles in which the temperature is sequentially varied between about −20° C. and about 20° C. In some embodiments, the number of freeze/thaw cycles, the temperature fluctuation, and/or other details can be different than disclosed herein, in accordance with a specific production protocol and/or implant design.
Following freeze/thaw cycling, the implant can be at least partially removed (e.g., including fully removed) from the mold and placed in one or more saline and/or other fluid (e.g., other liquid) baths where the implant can be subjected to additional cooling and/or other treatment procedures (e.g., to further stabilize the physical properties of the implant). In some embodiments, the implant undergoes an additional eight freeze/thaw cycles while in saline. In some embodiments, such follow-up cooling procedures can be either different (e.g., more or fewer freeze/thaw cycles, different type of bath, etc.) or altogether eliminated from the production process, as desired or required.
When the cooling (e.g., freeze/thaw cycling) and/or other manufacturing processes have been completed, the implants can be inspected for any manufacturing flaws or other defects. At least some of the implants can be subjected to selective testing for physical and other characteristics, in accordance with the original design goals and/or target parameters. The implant may be cut or otherwise processed to remove any excess portions (e.g., flash). In some embodiments, one or more completed implant is packaged in hermetically sealed plastic trays or other containers comprising foil or other types of lids or covering members. A volume of saline and/or other liquid can be included within such trays or other containers to provide hydration of the implant(s) during storage and/or any other steps preceding use. In some embodiments, the implant tray or other container is terminally sterilized using e-beam exposure between about 25 kilogray (kGy) and about 40 kGy.
Additional details related to implants comprising hydrogels, including methods of manufacturing and use, can be found in U.S. Pat. Nos. 5,981,826, 6,231,605, and PCT Patent Application Publication No. WO 2012/162552, each of which is hereby incorporated by reference in its entirety for all purposes.
Implant dimensions, shapes, angles, tooling used to make non-cylindrical bone apertures, tooling to deploy non-cylindrical implants, potential advantages, etc. may be the same as or similar to (e.g., including appropriate modification to include porous material as understood from the present application) the hydrogel implants comprising wedge shapes are described in U.S. Pat. No. 9,155,543, which is hereby incorporated by reference in its entirety for all purposes.
In some embodiments, the porous material may be selected based on bone infiltration characteristics and/or dimensions of the third portion 706. In certain such embodiments, the height and/or shape of the second portion 704 may be at least partially based on a porosity of the porous material. For example, if the porous material is more porous, then hydrogel infiltration into the porous material will be greater, so less porous material may be used. Conversely, if the porous material is less porous, then hydrogel infiltration into the porous material will be less, so more porous material may be used.
The hole 710 preferably has a depth that is greater than or equal to the height of the second portion 704 and the third portion 706 such that the part of the implant 700 prolapsing from the bone portion 708, the load-bearing surface, comprises hydrogel and is free or substantially free of the relatively more rigid porous material. In some embodiments, an upper surface of the implant 700 is about 1 millimeter (mm) to about 7 mm above an upper surface of the bone portion 708 (e.g., the bone of the bone portion, remaining cartilage, etc.), which can provide a desired contour of the damaged joint surface. In some embodiments, such a raised or otherwise protruding configuration can assist in creating a smoother transition between the exposed surface of the implant 700 and adjacent native surfaces.
As a result of the shape of the implant 700 and the corresponding implant site (e.g., in the hole 710), the implant 700 may be inwardly radially compressed in order to insert the implant 700 in the hole 710. A delivery system or introducer and/or other delivery tools can be used to facilitate positioning of the implant 700. Radially inward compressive forces may facilitate delivery of the implant 700 that is at radially oversized relative to the top of the hole 710. The degree to which the implant 700 can be compressed (e.g., circumferentially, radially inwardly, etc.) may depend on one or more factors, properties, characteristics and/or other considerations of the first portion 702, such as, for example, implant size, water content, ingredients and other components, strength, elasticity, surrounding temperature, method of manufacturing, and/or the like. Although described herein as generally rigid, the second portion 704 and the third portion 706 may also have some degree of compressibility. Radial compression of an implant 700 can affect the overall height, the shape and/or contours of outer surfaces (e.g., top or articulating surface, base or bottom surface, sides, etc.), and/or one or more other properties or characteristics of the implant 700. In some embodiments, radial compression of an implant 700 causes the height of the implant 700 to increase (e.g., relative to the height of the implant 700 when not radially compressed). Consequently, careful consideration may be given to the design of the implant 700 based on, among other things, the expected level of radial compression that may occur once the implant 700 has been properly secured in the hole 710, prior to implantation. Otherwise, in some embodiments, upon implantation, an implant 700 may not properly align with adjacent cartilage or other tissue surfaces in a joint or other anatomical location.
Interaction between the sidewalls of the hole 710 and the edges of the implant 700 can create a downward force, which can create a more secure implantation (e.g., resisting dislodge forces). Interaction between the sidewalls of the hole 710 and the edges of the implant 700 can create a downward force, which can help the third portion 706 make contact with the bottom of the hole 710, which can improve bone infiltration into the third portion 706.
In some embodiments, the third portion and the hole may have non-uniform lateral cross-sections. For example, the bottom of the third portion may have an ellipse shape having a length greater than a width, and the top of the hole may have an oval shape having a length greater than a width. During implantation, the implant may be positioned such that the length and width of the third portion are aligned with the length and width of the hole. The generally rigid third portion may fit through the hole when aligned, but the generally rigid third portion may not fit through the hole when the implant is rotated. For example, after rotation, the length of the third portion may not be able to fit through a width of the hole. If the length of an ellipse compared to a circle in a third portion for an otherwise same implant may increase the area of contact between the bottom of the third portion and the bottom of the hole by about 10% to about 50% (e.g., about 10%, about 20%, about 30%, about 40%, about 50%, ranges between such values, etc.). In some embodiments, the implant may be rotated until sides of the third portion make contact with the hole. Contact between sides of the third portion and sides of the hole may provide increased area for bone infiltration and/or increase downward force.
When the implant 720 is inserted into a hole 740 in a bone segment 732 that comprises a secondary hole 742, the anchor 728 can fit into the secondary hole 742. The anchor 728 can flex inwardly during insertion and then is resistant to retraction. The anchor 728 can maintain a downward force on the third portion 726 against the bottom of the hole 740. The force may be advantageous at least until bone infiltration, which may be complete enough to anchor the implant without the anchor 728 in about six to eight weeks. In some embodiments, the secondary hole 742 can be formed while forming a pilot hole (e.g., using a dual diameter drill bit). In some embodiments, the secondary hole 742 can be formed before or after forming a pilot hole (e.g., using a different drill bit), before or after forming a shape such as a wedge. In some embodiments in which a guide pin is used for procedures like drill bit alignment, the secondary hole 742 may be a result of removal of the guide pin.
The hole 810 preferably has a depth that is greater than or equal to the height of the second portion 804 and the third portion 806 such that the part of the implant 800 prolapsing from the bone portion 808, the load-bearing surface, comprises hydrogel and is free or substantially free of the relatively more rigid porous material. In some embodiments, an upper surface of the implant 800 is about 1 millimeter (mm) to about 7 mm above an upper surface of the bone portion 808 (e.g., the bone of the bone portion, remaining cartilage, etc.), which can provide a desired contour of the damaged joint surface. In some embodiments, such a raised or otherwise protruding configuration can assist in creating a smoother transition between the exposed surface of the implant 800 and adjacent native surfaces.
As a result of the shape of the implant 800 and the corresponding implant site (e.g., in the hole 810), the implant 800 may be inwardly radially compressed in order to insert the implant 800 in the hole 810. A delivery system or introducer and/or other delivery tools can be used to facilitate positioning of the implant 800. Radially inward compressive forces may facilitate delivery of the implant 800 that is at radially oversized relative to the top of the hole 810. The degree to which the implant 800 can be compressed (e.g., circumferentially, radially inwardly, etc.) may depend on one or more factors, properties, characteristics and/or other considerations of the first portion 802, such as, for example, implant size, water content, ingredients and other components, strength, elasticity, surrounding temperature, method of manufacturing, and/or the like. Although described herein as generally rigid, the second portion 804 and the third portion 806 may also have some degree of compressibility. Radial compression of an implant 800 can affect the overall height, the shape and/or contours of outer surfaces (e.g., top or articulating surface, base or bottom surface, sides, etc.), and/or one or more other properties or characteristics of the implant 800. In some embodiments, radial compression of an implant 800 causes the height of the implant 800 to increase (e.g., relative to the height of the implant 800 when not radially compressed). Consequently, careful consideration may be given to the design of the implant 800 based on, among other things, the expected level of radial compression that may occur once the implant 800 has been properly secured in the hole 810, prior to implantation. Otherwise, in some embodiments, upon implantation, an implant 800 may not properly align with adjacent cartilage or other tissue surfaces in a joint or other anatomical location.
Interaction between the sidewalls of the hole 810 and the edges of the implant 810 can create a downward force, which can create a more secure implantation (e.g., resisting dislodge forces). Interaction between the sidewalls of the hole 810 and the edges of the implant 800 can create a downward force, which can help the third portion 806 make contact with the bottom of the hole 810, which can improve bone infiltration into the third portion 806. The sides of the third portion 806 may appose the sidewalls of the lower segment of the hole 810 and contact the bottom of the hole 810, which can provide a large area for bone infiltration.
The implant 900 also comprises a second part 908. The second part 908 comprises an annular rim, a bottom, and a barb 910. The rim and the bottom at least partially define a cavity configured to receive the first part 901. In some embodiments, the barb 910 is monolithic (formed from a single piece of material) with the remainder of the second part 908. In some embodiments, the barb 910 is formed separately from the remainder of the second part 908 and coupled to the remainder of the second part 908. The second part 908 may comprise a rigid material such as metal, ceramic, plastic, etc. The second part 908 may be formed, for example, by metal casting, injection molding, milling, printing, combinations thereof, etc.
The barb 908 may be inwardly compressible when longitudinally advanced, for example into a hole in a bone site, but configured to catch when longitudinally retracted, for example from a hole in a bone site. The second part 908 may comprise a porous material (e.g., to allow bone infiltration) and/or non-porous material (e.g., the second part 908 being anchored by the barb 908).
The second part 908 may be inserted at an implant site (e.g., a hole in a bone site) and the first part 901 may be inserted into the second part 908, and thus also into the implant site. As best seen in
The implant 1000 also comprises a second part 1008. The second part 1008 comprises an annular rim, a bottom, and an anchor 1010. The rim and the bottom at least partially define a cavity configured to receive the first part 1001. The second part 1008 may comprise a rigid material such as metal, ceramic, plastic, etc. The second part 1008 may be formed, for example, by metal casting, injection molding, milling, printing, combinations thereof, etc. The second part 1008 may comprise a porous material (e.g., to allow bone infiltration) and/or non-porous material (e.g., the second part 1008 being anchored by the barb 1008).
The anchor 1010 comprises an insert 1022 and radially outwardly extending fingers 1024. The anchor 1010 may be coupled to the second part 1008 by a wire 1026 extending through holes 1009 and forming a knot 1028. The anchor 1010 may be pushed into a hole (e.g., a hole in a bone site). The fingers 1024 may flex radially inwardly during advancement into the hole and flex radially outward to inhibit dislodgement from the hole. Ends of the wire 1026 may optionally form a loop. When ends of the wire 1026 are pulled, the knot 1028 tightens to draw the second part 1008 and the anchor 1010 closer together. The anchor 1010 is inhibited from retracting, so the tightening pushes the second part 1008 into the hole. In some embodiments, the anchor 1010 shares features with the anchors described in U.S. Patent Pub. No. 2015/0351815, which is incorporated herein by reference in its entirety for all purposes.
The second part 1008 may be inserted at an implant site (e.g., a hole in a bone site) and tightened, and the first part 1001 may be inserted into the second part 1008, and thus also into the implant site. As best seen in
The implant 1100 also comprises a second part 1108. The second part 1108 comprises an annular rim and a bottom. The rim and the bottom at least partially define a cavity configured to receive the first part 1101. The second part 1108 may comprise a rigid material such as metal, ceramic, plastic, etc. The second part 1108 may be formed, for example, by metal casting, injection molding, milling, printing, combinations thereof, etc. The second part 1108 may comprise a porous material (e.g., to allow bone infiltration) and/or non-porous material (e.g., the second part 1108 being anchored by the barb 1108).
The bottom of the second part 1108 comprises a plurality of holes 1109 configured to receive screws 1110. In some embodiments, the bottom of the second part 1108 comprises one hole 1109, two holes 1109, three holes 1109, four holes 1109 (e.g., as shown in
The second part 1108 may be inserted at an implant site (e.g., a hole in a bone site). One or more screws 1010 may be inserted through holes 1109 to tighten the second part 1108 against the hole. The first part 1101 may be inserted into the second part 1108, and thus also into the implant site. As best seen in
The height of the porous material 1204 may be at least partially based on the intended use of the implant 1200. For example, if the intended use is a small joint (e.g., in a hand or foot), a larger profile and a less proud hydrogel 1202 generally reduces the chances of dislocation.
With respect to any of the implants described herein in which the porous material comprises metal, the implant may advantageously be visible under x-ray.
With respect to any of the implants described herein, comprising porous material allowing fixation due to bone infiltration and/or comprising a fixation device such as a barb, anchor, screw, etc., an overall height can be reduced versus and implant, for example, consisting essentially of hydrogel (e.g., lacking porous material and/or a fixation device), which generally uses interaction between a long bone hole and a large height to provide anti-dislodging force. In some embodiments, an anchored implant can have a height that is less than a height of an equivalent but unanchored implant by about 10% to about 60% (e.g., about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, ranges between such values, etc.). For example, if a hydrogel implant has a diameter of 10 mm and a height of 10 mm, then an implant as described herein may have a diameter of 10 mm and a height of 5 mm such that the height is 50% less.
Although several embodiments and examples are disclosed herein, the present application extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the various inventions and modifications, and/or equivalents thereof. It is also contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the inventions. Accordingly, various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed inventions. Thus, the scope of the various inventions disclosed herein should not be limited by any particular embodiments described above. While the embodiments disclosed herein are susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are described in detail herein. However, the inventions of the present application are not limited to the particular forms or methods disclosed, but, to the contrary, cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various embodiments described and the appended claims. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element and/or the like in connection with an implementation or embodiment can be used in all other implementations or embodiments set forth herein.
In any methods disclosed herein, the acts or operations can be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence and not be performed in the order recited. Various operations can be described as multiple discrete operations in turn, in a manner that can be helpful in understanding certain embodiments; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, any structures described herein can be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, embodiments can be carried out in a manner that achieves or optimizes one advantage or group of advantages without necessarily achieving other advantages or groups of advantages.
The methods disclosed herein include certain actions taken by a practitioner; however, they can also include any third-party instruction of those actions, either expressly or by implication. For example, actions such as “deploying an implant” include “instructing deployment of an implant.” The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “about” or “approximately” include the recited numbers and should be interpreted based on the circumstances (e.g., as accurate as reasonably possible under the circumstances, for example ±5%, ±10%, ±15%, etc.). For example, “about 1 mm” includes “1 mm.” Phrases preceded by a term such as “substantially” include the recited phrase and should be interpreted based on the circumstances (e.g., as much as reasonably possible under the circumstances). For example, “substantially rigid” includes “rigid” and “substantially parallel” includes “parallel.”
The present application is a continuation of U.S. patent application Ser. No. 15/909,077, filed Mar. 1, 2018 which is a continuation of U.S. patent application Ser. No. 15/085,840, filed Mar. 30, 2016 and issued as U.S. Pat. No. 9,907,663, which claims priority benefit of U.S. Provisional Patent App. No. 62/141,059, filed on Mar. 31, 2015.
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| Number | Date | Country | |
|---|---|---|---|
| 20210220142 A1 | Jul 2021 | US |
| Number | Date | Country | |
|---|---|---|---|
| 62141059 | Mar 2015 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15909077 | Mar 2018 | US |
| Child | 17197595 | US | |
| Parent | 15085840 | Mar 2016 | US |
| Child | 15909077 | US |
