During implant surgery, it may be necessary to provide drugs, biologics, bone cement, and/or other materials (“delivered material”) on a bone interface side of an implant and/or between an implant and a bone. The delivered material may be provided to increase bone growth onto and/or into the implant, fill voids in a bone, and/or for any other suitable purpose.
Current materials typically include liquid or gel-like delivered materials. During surgery, it may be difficult to maintain the delivered materials in a fixed position while inserting an implant. For example, in some instances, the delivered material may be squeezed out or dislodged due to implant seating.
In various embodiments, a surgical implant includes a body extending between a proximal surface and a distal surface. The body is sized and configured to be coupled to an anatomical structure at an implantation site. A first inlet port is formed in a distal surface of the body. The inlet port is sized and configured to receive a first material. A first outlet port is formed in the proximal surface of the body. The first outlet port is coupled to the first inlet port by a first fluid path defined by the body. The first outlet port is sized and configured to provide the first material to a first predetermined location when the body is coupled to the anatomical structure.
In various embodiments, a surgical implant includes a body extending between a proximal surface and a distal surface. The body is sized and configured to be coupled to an anatomical structure at an implantation site, and wherein the proximal surface comprises a porous portion. A first inlet port is formed in a distal surface of the body. The inlet port is sized and configured to receive a first material. A first outlet port is formed in the proximal surface of the body. The first outlet port is coupled to the first inlet port by a first fluid path defined by the body. The first outlet port is sized and configured to provide the first material to the porous portion of the proximal surface.
In various embodiments, a method is provided for delivering a material within an implantation site in a patient. The method includes the step of positioning an implant adjacent to and in contact with at least one anatomical structure. The implant includes a body extending between a proximal surface and a distal surface sized and configured to be coupled to the anatomical structure at a predetermined location, a first inlet port formed in a distal surface of the body is sized and configured to receive a first material, and a first outlet port formed in the proximal surface of the body is coupled to the first inlet port by a first fluid path defined by the body. A first material is provided to the inlet port and the first material is delivered to the predetermined location by the first material passing through the first fluid path to the first outlet port.
The features and advantages of the invention will be more fully disclosed in, or rendered obvious by the following detailed description of preferred embodiments, which are to be considered together with the accompanying drawings wherein like numbers refer to like parts and further wherein:
The description of the exemplary embodiments is intended to be read in connection with the accompanying drawings, which are to be considered part of the entire written description. In the description, relative terms such as “lower,” “upper,” “horizontal,” “vertical,” “proximal,” “distal,” “above,” “below,” “up,” “down,” “top” and “bottom,” as well as derivatives thereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should be construed to refer to the orientation as then described or as shown in the drawing under discussion. These relative terms are for convenience of description and do not require that the apparatus be constructed or operated in a particular orientation. Terms concerning attachments, coupling and the like, such as “connected” and “interconnected,” refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise.
As used herein, the term “substantially” denotes elements having a recited relationship (e.g., parallel, perpendicular, aligned, etc.) within acceptable manufacturing tolerances. For example, as used herein, the term “substantially parallel” is used to denote elements that are parallel or that vary from a parallel arrangement within an acceptable margin of error, such as +/−5°, although it will be recognized that greater and/or lesser deviations can exist based on manufacturing processes and/or other manufacturing requirements.
In various embodiments, a system and method for delivering a material to an implantation site are disclosed. The system includes an implant having at least one entry port formed in a distal surface of the implant. The entry port is sized and configured to receive a material therein. The material may include, but is not limited to, a liquid or gel-like drug, biologic, bone cement, and/or other therapeutic or restorative material. The entry port is in fluid-communication with one or more exit ports formed in a proximal surface and/or proximal structure of the implant. For example, in some embodiments, the entry port is coupled to one or more exit ports by an internal channel, although it will be appreciated that any suitable fluid coupling may be used. The one or more exit ports are sized and configured to deliver the liquid or gel-like delivered material to one or more predetermined positions after the implant is positioned in contact with a bone.
In various embodiments, the method includes a step of positioning an implant in contact with a bone at a predetermined implantation site. After positioning the implant, a liquid or gel-like material is provided to an entry port formed in a distal surface of the implant. The delivered material is guided from the entry port to one or more exit ports by one or more internal channels defined by the implant. The delivered material is provided to one or more predetermined locations with respect to the implantation site by the exit ports.
The implant 100 includes a body 102 extending between a distal surface 104 and a proximal surface 106. A sidewall 108 defines a perimeter of the body 102. The sidewall 108 defines a predetermined shape of the implant configured to correspond to an implantation site. In some embodiments, the sidewall 108 is configured to match a contour of a patient bone, although it will be appreciated that the sidewall 108 may have any suitable shape, including a patient-specific and/or patient-universal shape.
In the illustrated embodiments, the distal surface 104 and the proximal surface 106 each define generally planar surfaces, although it will be appreciated that the surface topography may be configured to match the surface of a bone to which the implant is mounted. The distal surface 104 may include a protrusion 112, such as a peg, morse taper, and/or other protrusion extending distally from the distal surface 104 (
In some embodiments, the distal surface 104 defines one or more inlet ports 110a, 110b (collectively “inlet ports 110”). The inlet ports 110 may be defined through any portion of the distal surface 104 and/or any structure formed on the distal surface 104. For example, in some embodiments, a first inlet port 110a is formed in the distal surface 104 and a second inlet port 110b is formed in the inset surface 120. Although embodiments are discussed herein including a plurality of inlet ports 110, it will be appreciated that the first inlet port 110a and/or the second inlet port 110b may be omitted such that the implant 100 includes only a single inlet port 110. As discussed in greater detail below, the inlet ports 110 are in fluid communication with one or more outlet ports formed on a proximal surface of the implant 100.
In some embodiments, at least one of the inlet ports 110 is defined by an opening formed in the distal surface 104 of the implant 100 and extending at least partially into the body of the implant 100. In some embodiments, one or more of the inlet ports 110 may taper from a first diameter at the distal surface 104 to a second diameter at a predetermined distance into the body 102. In some embodiments, one or more of the inlet ports 110 defines a constant diameter.
Referring to
Each of the pegs 130 are sized and configured to be received within a peg hole formed in a bone prior to positioning of the implant 100 adjacent to and in contact with the bone. For example, in embodiments including an implant 100 configured to be coupled to a joint surface for joint replacement, one or more peg holes may be formed in a resected bone to maintain the implant 100 in a fixed position. Although pegs 130 are discussed herein, it will be appreciated that the proximal surface 106 may include any suitable surface features, such as pegs, contours, surface treatments, etc. configured to maintain the implant 100 in a fixed position with respect to a bone.
Referring to
In some embodiments, the stem 132 is configured to be received within a stem hole formed in a bone prior to positioning of the implant 100 adjacent to and in contact with the bone. In some embodiments, the stem 132 is configured to position and/or orient the implant 100 with respect to the bone surface and/or one or more other features, such as, for example, alignment of a joint surface. Although multiple embodiments are discussed, including a stem 132, it will be appreciated that the stem 132 may be omitted.
Referring to
For example, in some embodiments, one or more of the outlet ports 136 are positioned to deliver a fixation material, such as a bone cement, to one or more predetermined locations at an implantation site after positioning of the implant 100 adjacent to and in contact with the implantation site. As another example, in some embodiments, one or more of the outlet ports 136 may be configured to provide a biological treatment material, such as drugs, biologics, bone-growth material, etc., to one or more predetermined locations at an implantation site.
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In some embodiments, a plurality of exit channels 156a-156c (collectively “exit channels 156”) extend from the first channel 152 and/or the second channel 154 to one of the plurality of outlet ports 136b-136d. In some embodiments, each of the exit channels 156 extends from a proximal end of the first channel 154, although it will be appreciated that the exit channels 156 may be coupled to the first channel 152 and/or the second channel 154 at any suitable location. As shown in
In some embodiments, the implant 100 is formed by an additive manufacturing process, such as, for example, sintering processes, melting processes, and/or stereolithography processes. Such additive manufacturing processes may include, but are not limited to, binder jetting, directed energy deposition, material extrusion, powder bed fusion, sheet lamination, vat polymerization, Directed Energy Deposition-Arc (DED-arc) (e.g., wire arc additive manufacturing), and/or any other suitable additive manufacturing process. In some embodiments, the implant 100 may be formed as a single, monolithic implant. In some embodiments, portions of the implant 100 may be formed separately by additive manufacturing and/or traditional manufacturing and coupled together to form implant 100.
Referring to
The porous proximal body portion 170 and the porous proximal surface 106a are configured to allow fluid transfer from one or more exit ports 136 through the porous proximal surface 106a to one or more locations at an implant site. In some embodiments, the porous proximal body portion 170 is configured to distribute the delivered material over a larger surface area of the proximal surface 106a as compared to delivery exclusively through the exit ports 136. For example, in some embodiments, the porous proximal body portion 170 may allow the delivered material to substantially distribute over the entirety of the proximal surface 106a and/or some predetermined portion of the proximal surface 106a, allowing distribution of the delivered material over the entirety and/or a predetermined portion of an implantation site.
Referring to
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For example, in some embodiments, the porous proximal body portion 170 has a porosity configured to provide the delivered material over substantially most of the proximal planar surface 106a co-located with the stem 132. As another example, in some embodiments, the porous proximal body portion 170 has a porosity configured to provide the delivered material to predetermined portions of the porous proximal body portion 170 co-located with the stem 132. Although various embodiments are discussed herein, it will be appreciated that any suitable porosity and/or porosity gradient may be selected to provide a desired diffusion of a delivered material.
As discussed above with respect to implant 100, the implant 100a may be formed using an additive manufacturing process, such as, for example, sintering processes, melting processes, and/or stereolithography processes. Such additive manufacturing processes may include, but are not limited to, binder jetting, directed energy deposition, material extrusion, powder bed fusion, sheet lamination, vat polymerization, Directed Energy Deposition-Arc (DED-arc) (e.g., wire arc additive manufacturing), and/or any other suitable additive manufacturing process. In some embodiments, the implant 100a may be formed as a single, monolithic implant having the porous proximal body portion 170 formed integrally with the non-porous distal body portion 172 during the additive manufacturing process. In some embodiments, portions of the implant 100, such as the porous proximal body portion 170 and the non-porous distal body portion 172, may be formed separately by additive manufacturing and/or traditional manufacturing and coupled together to form implant 100.
At step 204, after positioning the implant, a first material is provided to a first inlet port 110a of the implant. The first material may include any suitable biocompatible material, including, but not limited to, a liquid or gel-like material. Examples of suitable materials include, but are not limited to, drugs, biologics, bone cement, and/or other suitable materials.
At step 206, the first material is provided to one or more predetermined locations with respect to the implantation site via one or more outlet ports, such as a first outlet port 132a. The first material may be provided from the first inlet port 110a to the first outlet port 132a via one or more fluid paths, such as a continuously tapered fluid path 140. In some embodiments, the first outlet port 132a opens directly to a predetermined location with respect to the implantation site. In some embodiments, the first outlet port 132a may interact with one or more additional elements, such as a porous proximal body portion 170.
At optional step 208, a second material is provided to a second inlet port 110a of the implant. The second material may include any suitable biocompatible material, including, but not limited to, a liquid or gel-like material. Examples of suitable materials include, but are not limited to, drugs, biologics, bone cement, and/or other suitable materials. The second material may be the same material as the first material or a different material.
At optional step 210, the second material is provided to one or more predetermined locations with respect to the implantation site via one or more outlet ports, such as a plurality of outlet ports 132b-132d. The second material may be provided from the second inlet port 110a to the plurality of outlet ports 132b-132d via one or more fluid paths, such as a branching fluid path 150. In some embodiments, the plurality of outlet ports 132b-132d each open directly to a predetermined location with respect to the implantation site. In some embodiments, the plurality of outlet ports 132b-132d interact with one or more additional elements, such as a porous proximal body portion 170.
At optional step 212, a third material is provided to the first inlet port 110a and/or the second inlet port 110b. The third material may include any suitable biocompatible material, including, but not limited to, a liquid or gel-like material. Examples of suitable materials include, but are not limited to, drugs, biologics, bone cement, and/or other suitable materials. The third material may be the same material as the first material, the same as the second material, or a different material.
Although the subject matter has been described in terms of exemplary embodiments, it is not limited thereto. Rather, the appended claims should be construed broadly, to include other variants and embodiments, which may be made by those skilled in the art.
This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 63/241,223, filed on Sep. 7, 2021, the entire contents of which are incorporated herein by reference.
Number | Date | Country | |
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63241223 | Sep 2021 | US |