Description:BACKGROUND
Field of Invention
[001] Embodiments of the present invention generally relate to a bioresorbable fracture implant and particularly to a bioresorbable fracture implant printable using three-dimensional printing technology.
Description of Related Art
[002] Artificial joints or implants often prove to be temporary solutions, as joint replacements fail over time, leading to more complex surgeries. Additionally, prolonged metal contact within the bone contributes to wear, resulting in loosening or failure of the implants. Furthermore, utilizing bone cement, specifically, Plaster of Paris (POP), and implanting a tibial tray within the early to mid-cement-specific processing window proves advantageous in various cases. However, these methods encounter challenges in achieving successful composite fracture fixation.
[003] Moreover, numerous bone fracture surgeries involve the use of titanium plates and rods, which are affixed to both sides of the bone through screws. This procedure entails a significant amount of time for both surgery and recovery, occasionally necessitating additional post-surgery interventions.
[004] Nevertheless, the utilization of rod implants in knee surgeries for fractures occasionally results in infections or misalignment, leading to implant failure. Reactivity issues can trigger inflammation, elevated body temperature, discomfort in patients, and itching at the interface between blood cells and the implant. Moreover, the growth of muscle tissue along the implant often leads to restenosis, causing infection and necessitating additional surgery to remove the supports.
[005] There is thus a need for an improved and advanced bioresorbable fracture implant printable using a three-dimensional printing technology that can administer the aforementioned limitations in a more efficient manner.
SUMMARY
[006] Embodiments in accordance with the present invention provide a bioresorbable fracture implant printable using a three-dimensional printing technology. The bioresorbable fracture implant comprising: a plate board having a first surface and a second surface. The plate board is made of a bioresorbable polymer material selected from a polylactic acid (PLA) and polycaprolactone (PCL). The bioresorbable fracture implant further comprising: an implant profile extended from the plate board. The implant profile comprises pass-through holes to allow passage of blood through and to regenerate growing cells. The bioresorbable fracture implant further comprising: screws adapted to be inserted on contours provided on the plate board to fix the bioresorbable fracture implant to a bone structure.
[007] Embodiments in accordance with the present invention further provide a method for manufacturing a bioresorbable fracture implant using a three-dimensional printing technology. The method comprising steps of: measuring dimensions of an implant profile; optimizing the implant profile using topology optimization techniques; fabricating the bioresorbable fracture implant using a Fused Deposition Modelling (FDM); aligning the implant profile extending from a plate board on a fracture of a bone structure; ensuring a passage of blood through pass-through holes for regeneration of growing cells; inserting screws on contours; and screwing the screws to fix the bioresorbable fracture implant to the bone structure.
[008] Embodiments of the present invention may provide a number of advantages depending on their particular configuration. First, embodiments of the present application may provide a bioresorbable fracture implant printable using a three-dimensional printing technology.
[009] Next, embodiments of the present application may provide a bioresorbable fracture implant printable using a three-dimensional printing technology that features a design for early healing of fracture on a bone piece.
[0010] Next, embodiments of the present application may provide a bioresorbable fracture implant printable using a three-dimensional printing technology that disintegrates inside a human body and is not needed for removal after healing of the fracture.
[0011] Next, embodiments of the present application may provide a bioresorbable fracture implant printable using a three-dimensional printing technology that securely covers the fracture and improves bone fracture adhesion.
[0012] Next, embodiments of the present application may provide a bioresorbable fracture implant printable using a three-dimensional printing technology that has a high coverage percentage that is closely related to a restenosis rate.
[0013] These and other advantages will be apparent from the present application of the embodiments described herein.
[0014] The preceding is a simplified summary to provide an understanding of some embodiments of the present invention. This summary is neither an extensive nor exhaustive overview of the present invention and its various embodiments. The summary presents selected concepts of the embodiments of the present invention in a simplified form as an introduction to the more detailed description presented below. As will be appreciated, other embodiments of the present invention are possible utilizing, alone or in combination, one or more of the features set forth above or described in detail below.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The above and still further features and advantages of embodiments of the present invention will become apparent upon consideration of the following detailed description of embodiments thereof, especially when taken in conjunction with the accompanying drawings, and wherein:
[0016] FIG. 1A illustrates a diagram of a bioresorbable fracture implant printable using three-dimensional printing technology, according to an embodiment of the present invention;
[0017] FIG. 1B illustrates a line drawing of the bioresorbable fracture implant printable using the three-dimensional printing technology, according to an embodiment of the present invention;
[0018] FIG. 1C illustrates a top view of the bioresorbable fracture implant printable using the three-dimensional printing technology, according to an embodiment of the present invention;
[0019] FIG. 1D illustrates a right view of the bioresorbable fracture implant printable using the three-dimensional printing technology, according to an embodiment of the present invention;
[0020] FIG. 1E illustrates a front view of the bioresorbable fracture implant printable using the three-dimensional printing technology, according to an embodiment of the present invention;
[0021] FIG. 1F illustrates a left view of the bioresorbable fracture implant printable using the three-dimensional printing technology, according to an embodiment of the present invention; and
[0022] FIG. 2 depicts a flowchart of a method for manufacturing the bioresorbable fracture implant using the three-dimensional printing technology, according to an embodiment of the present invention.
[0023] The headings used herein are for organizational purposes only and are not meant to be used to limit the scope of the description or the claims. As used throughout this application, the word "may" is used in a permissive sense (i.e., meaning having the potential to), rather than the mandatory sense (i.e., meaning must). Similarly, the words “include”, “including”, and “includes” mean including but not limited to. To facilitate understanding, like reference numerals have been used, where possible, to designate like elements common to the figures. Optional portions of the figures may be illustrated using dashed or dotted lines, unless the context of usage indicates otherwise.
DETAILED DESCRIPTION
[0024] The following description includes the preferred best mode of one embodiment of the present invention. It will be clear from this description of the invention that the invention is not limited to these illustrated embodiments but that the invention also includes a variety of modifications and embodiments thereto. Therefore, the present description should be seen as illustrative and not limiting. While the invention is susceptible to various modifications and alternative constructions, it should be understood, that there is no intention to limit the invention to the specific form disclosed, but, on the contrary, the invention is to cover all modifications, alternative constructions, and equivalents falling within the scope of the invention as defined in the claims.
[0025] In any embodiment described herein, the open-ended terms "comprising", "comprises”, and the like (which are synonymous with "including", "having” and "characterized by") may be replaced by the respective partially closed phrases "consisting essentially of", “consists essentially of", and the like or the respective closed phrases "consisting of", "consists of”, the like.
[0026] As used herein, the singular forms “a”, “an”, and “the” designate both the singular and the plural, unless expressly stated to designate the singular only.
[0027] FIG. 1A illustrates a diagram of a bioresorbable fracture implant 100 printable using a three-dimensional printing technology, according to an embodiment of the present invention. In an embodiment of the present invention, the bioresorbable fracture implant 100 may be adapted for adhesion of a fracture on a bone structure. In a preferred embodiment of the present invention, the bone structure may be a tibia bone of a human body. Embodiments of the present invention are intended to include or otherwise cover any bone structure of the human body whose fracture may be adhered by the bioresorbable fracture implant 100, including known, related art, and/or later developed technologies.
[0028] In an embodiment of the present invention, the bioresorbable fracture implant 100 may be fabricated as such for bio-absorption (bioresorbable) inside of the human body. The bioresorbable fracture implant 100 may be surgically planted on the fracture on the bone structure, however, upon adhesion and healing of the fracture on the bone structure, there may not be any requirement for surgical removal of the bioresorbable fracture implant 100, in an embodiment of the present invention.
[0029] In another embodiment of the present invention, the bioresorbable fracture implant 100 may be fabricated and printed using the three-dimensional printing technology. The three-dimensional printing technology may utilize Fused Deposition Modelling (FDM) for precise fabrication of the bioresorbable fracture implant 100, in an embodiment of the present invention. The Fused Deposition Modelling (FDM) may be a layer-by-layer printing technique for a three-dimensional print model manufacturing. The Fused Deposition Modelling (FDM) may utilize thermoplastic materials, that may further be extruded through a nozzle tip (not shown) while being heated to a semi-molten state and then deposited onto the substrate, leaving behind the three-dimensional print model object when the thermoplastic material may have been solidified.
[0030] Further, the bioresorbable fracture implant 100 may be optimized using topology optimization techniques. The topology optimization techniques may be a shape optimization method that uses algorithmic models to optimize material layout within a user-defined space for a given set of loads, conditions, and constraints.
[0031] In an embodiment of the present invention, the bioresorbable fracture implant 100 may be printed in a reinforcing lattice structure within the implant profile to bolster compressional load resilience and bone growth during degradation.
[0032] Further, upon completion of printing of the bioresorbable fracture implant 100, the bioresorbable fracture implant 100 may be submersed in a Simulated Body Fluid (SBF) for a preset duration of time to maintain a pH of 7.4. The Simulated Body Fluid (SBF) may be a solution with an iron concentration close to that of a human blood plasma, in an embodiment of the present invention. In an embodiment of the present invention, the Simulated Body Fluid (SBF) may be kept under mild conditions of pH and identical physiological temperature as of the human body.
[0033] According to embodiments of the present invention, the bioresorbable fracture implant 100 may comprise a plate board 102, a first surface 104, a second surface 106, an implant profile 108, pass-through holes 110a-110n (hereinafter referred individually to as the pass-through hole 110, and plurally to as the pass-through holes 110), screws 112a-112d (hereinafter referred individually to as the screw 112, and plurally to as the screws 112), and contours 114a-114d (hereinafter referred individually to as the contour 114, and plurally to as the contours 114).
[0034] In an embodiment of the present invention, the plate board 102 may comprise the first surface 104 and the second surface 106. The plate board 102 may comprise rounded edges to ensure smoother adhesion to bone muscle, reducing discomfort or itching sensation under varying compression loads, in an embodiment of the present invention.
[0035] According to embodiments of the present invention, the plate board 102 may be constructed of any material such as, but not limited to, a metallic material, a wooden material, a ceramic material, a plastic material, and so forth. In a preferred embodiment of the present invention, the plate board 102 may be constructed of a polylactic acid (PLA) and polycaprolactone (PCL) material. Embodiments of the present invention are intended to include or otherwise cover any material for construction of the plate board 102, including known, related art, and/or later developed technologies.
[0036] In an embodiment of the present invention, the first surface 104 of the plate board 102 may be adapted to be arranged away from the bone structure. The first surface 104 of the plate board 102 may include micro-structuring to promote an osseointegration and a cellular adhesion, in an embodiment of the present invention.
[0037] In an embodiment of the present invention, the second surface 106 of the plate board 102 may be adapted to be arranged in contact with the bone structure. The second surface 106 may further provide a protrusion in form of the implant profile 108, in an embodiment of the present invention. In an embodiment of the present invention, the second surface 106 of the plate board 102 may include the micro-structuring to promote the osseointegration and the cellular adhesion.
[0038] In an embodiment of the present invention, the implant profile 108 may be extended from the second surface 106 of the plate board 102. The implant profile 108 may be extended at a specified angle from the second surface 106 of the plate board 102, in an embodiment of the present invention. In an embodiment of the present invention, the implant profile 108 may include the micro-structuring to promote the osseointegration and the cellular adhesion.
[0039] The implant profile 108 may be adapted to securely hold the bone structure with the fracture, in an embodiment of the present invention. In an embodiment of the present invention, the implant profile 108 may hold the bone structure in such a manner that fracture may be mitigated. Further, the implant profile 108 may be adapted to continue holding the bone structure with the fracture, which may lead to healing of the fracture on the bone structure.
[0040] In an embodiment of the present invention, the implant profile 108 may be specifically designed based on a custom requirement of the fracture on the bone structure. The implant profile 108 may be designed with custom dimensions, in an embodiment of the present invention. In an embodiment of the present invention, the dimensions for the implant profile 108 may be retrieved from sources, such as, but not limited to, an X-ray file, a Magnetic Resonance Imaging (MRI) file, a Computed Tomography (CT) scan file, and so forth. Embodiments of the present invention are intended to include or otherwise cover any sources for the retrieval of the dimensions of the implant profile 108, including known, related art, and/or later developed technologies.
[0041] According to embodiments of the present invention, the dimensions of the implant profile 108 may be based on parameters such as, but not limited to, a length of an implant, a width of the implant, a thickness of the implant the bone structure, a muscle density, and so forth. Embodiments of the present invention are intended to include or otherwise cover any parameters that may be included in the dimensions of the implant profile 108, including known, related art, and/or later developed technologies.
[0042] In an embodiment of the present invention, the pass-through holes 110 may be arranged on the implant profile 108. The pass-through holes 110 may allow passage of blood through the fracture in the bone structure, in an embodiment of the present invention. In an embodiment of the present invention, the passage of blood may initiate a regeneration of growth cells. The growth cells may lead to adhesion and healing of the fracture on the bone structure, in an embodiment of the present invention.
[0043] In an embodiment of the present invention, the screws 112 may be adapted to be inserted on the contours 114 provided on the plate board 102 to fix the bioresorbable fracture implant 100 to the bone structure.
[0044] FIG. 1B illustrates a line drawing of the bioresorbable fracture implant 100 printable using the three-dimensional printing technology, according to an embodiment of the present invention.
[0045] According to embodiments of the present invention, a length (L1) of the bioresorbable fracture implant 100 may be in a range from 50 millimeters (mm) to 100 millimeters (mm). In a preferred embodiment of the present invention, the length (L1) of the bioresorbable fracture implant 100 may be 60 millimeters (mm). Embodiments of the present invention are intended to include or otherwise cover any length (L1) of the bioresorbable fracture implant 100.
[0046] According to embodiments of the present invention, a length (L2) of an upper part of the implant profile 108 of the bioresorbable fracture implant 100 may be in a range from 1 millimeter (mm) to 6 millimeters (mm). In a preferred embodiment of the present invention, the length (L2) of the upper part of the implant profile 108 of the bioresorbable fracture implant 100 may be 3 millimeters (mm). Embodiments of the present invention are intended to include or otherwise cover any length (L2) of the upper part of the implant profile 108 of the bioresorbable fracture implant 100.
[0047] According to embodiments of the present invention, a length (L3) of a lower part of the implant profile 108 of the bioresorbable fracture implant 100 may be in a range from 1 millimeter (mm) to 6 millimeters (mm). In a preferred embodiment of the present invention, the length (L3) of the lower part of the implant profile 108 of the bioresorbable fracture implant 100 may be 3 millimeters (mm). Embodiments of the present invention are intended to include or otherwise cover any length (L3) of the lower part of the implant profile 108 of the bioresorbable fracture implant 100.
[0048] According to embodiments of the present invention, a total length (L4) of the implant profile 108 of the bioresorbable fracture implant 100 may be in a range from 5 millimeters (mm) to 10 millimeters (mm). In a preferred embodiment of the present invention, the total length (L4) of the implant profile 108 of the bioresorbable fracture implant 100 may be 8.5 millimeters (mm). Embodiments of the present invention are intended to include or otherwise cover any total length (L4) of the implant profile 108 of the bioresorbable fracture implant 100.
[0049] According to embodiments of the present invention, a thickness (T1) of the plate board 102 of the bioresorbable fracture implant 100 may be in a range from 2 millimeters (mm) to 6 millimeters (mm). Embodiments of the present invention are intended to include or otherwise cover any thickness (T1) of the plate board 102 of the bioresorbable fracture implant 100.
[0050] According to embodiments of the present invention, a width (W1) of the implant profile 108 of the bioresorbable fracture implant 100 may be in a range from 20 millimeters (mm) to 40 millimeters (mm). Embodiments of the present invention are intended to include or otherwise cover any width (W1) of the implant profile 108 of the bioresorbable fracture implant 100.
[0051] FIG. 1C illustrates a top view of the bioresorbable fracture implant 100 printable using the three-dimensional printing technology, according to an embodiment of the present invention.
[0052] FIG. 1D illustrates a right view of the bioresorbable fracture implant 100 printable using the three-dimensional printing technology, according to an embodiment of the present invention.
[0053] FIG. 1E illustrates a front view of the bioresorbable fracture implant 100 printable using the three-dimensional printing technology, according to an embodiment of the present invention.
[0054] FIG. 1F illustrates a left view of the bioresorbable fracture implant 100 printable using the three-dimensional printing technology, according to an embodiment of the present invention.
[0055] FIG. 2 depicts a flowchart of a method 200 for manufacturing the bioresorbable fracture implant 100 using the three-dimensional printing technology, according to an embodiment of the present invention.
[0056] At step 202, the dimensions of the implant profile 108 of the bioresorbable fracture implant 100 may be measured.
[0057] At step 204, the implant profile 108 of the bioresorbable fracture implant 100 may be optimized.
[0058] At step 206, the bioresorbable fracture implant 100 may be fabricated by using the Fused Deposition Modelling (FDM).
[0059] At step 208, the bioresorbable fracture implant 100 may be submerged in the Simulated Body Fluid (SBF) for a preset duration of time to maintain a pH of 7.4.
[0060] At step 210, the implant profile 108 of the bioresorbable fracture implant 100 may be aligned with the fracture of the bone structure.
[0061] At step 212, the pass-through holes 110 of the bioresorbable fracture implant 100 may ensure the passage of blood for regeneration of the growing cells.
[0062] At step 214, the screws 112 on the contours 114 of the bioresorbable fracture implant 100 may be inserted in the bone structure.
[0063] At step 216, the screws 112 may be screwed to securely fix the bioresorbable fracture implant 100 to the bone structure.
[0064] While the invention has been described in connection with what is presently considered to be the most practical and various embodiments, it is to be understood that the invention is not to be limited to the disclosed embodiments, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the scope of the appended claims.
[0065] This written description uses examples to disclose the invention, including the best mode, and also to enable any person skilled in the art to practice the invention, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the invention is defined in the claims and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements within substantial differences from the literal languages of the claims. , Claims:CLAIMS
I/We Claim:
1. A bioresorbable fracture implant (100) printable using a three-dimensional printing technology, characterized in that the bioresorbable fracture implant (100) comprising:
a plate board (102) having a first surface (104) and a second surface (106), wherein the plate board (102) is made of a bioresorbable polymer material selected from a polylactic acid (PLA) and polycaprolactone (PCL);
an implant profile (108) extended from the plate board (102), wherein the implant profile (108) comprises pass-through holes (110a-110n) to allow passage of blood through and to regenerate growing cells; and
screws (112a-112d) adapted to be inserted on contours (114a-114d) provided on the plate board (102) to fix the bioresorbable fracture implant (100) to a bone structure.
2. The bioresorbable fracture implant (100) as claimed in claim 1, wherein dimensions of the implant profile (108) are based on parameters, selected from a length of an implant, a width of the implant, a thickness of the implant the bone structure, a muscle density, or a combination thereof.
3. The bioresorbable fracture implant (100) as claimed in claim 1, wherein the first surface (104) of the plate board (102), the second surface (106) of the plate board (102), and the implant profile (108) include micro-structuring to promote an osseointegration and a cellular adhesion.
4. The bioresorbable fracture implant (100) as claimed in claim 1, wherein the plate board (102) comprises rounded edges to ensure smoother adhesion to bone muscle, reducing discomfort or itching sensation under varying compression loads.
5. The bioresorbable fracture implant (100) as claimed in claim 1, wherein the three-dimensional printing technology utilizes a Fused Deposition Modelling (FDM) for precise fabrication of the bioresorbable fracture implant (100).
6. The bioresorbable fracture implant (100) as claimed in claim 1, wherein the implant profile (108) is optimized using topology optimization techniques.
7. The bioresorbable fracture implant (100) as claimed in claim 1, comprising a reinforcing lattice structure within the implant profile (108) to bolster compressional load resilience and bone growth during degradation.
8. A method (200) for manufacturing a bioresorbable fracture implant (100) using a three-dimensional printing technology, the method (200) characterized by steps of:
measuring dimensions of an implant profile (108);
optimizing the implant profile (108) using topology optimization techniques;
fabricating the bioresorbable fracture implant (100) using a Fused Deposition Modelling (FDM);
aligning the implant profile (108) extending from a plate board (102) on a fracture of a bone structure;
ensuring a passage of blood through pass-through holes (110a-110n) for regeneration of growing cells;
inserting screws (112a-112d) on contours (114a-114d); and
screwing the screws (112a-112d) to fix the bioresorbable fracture implant (100) to the bone structure.
9. The method (200) as claimed in claim 8, comprises a step of submerging the bioresorbable fracture implant (100) in a Simulated Body Fluid (SBF) for a preset duration of time to maintain a pH of 7.4.
10. The method (200) as claimed in claim 8, wherein dimensions of the implant profile (108) are based on parameters, selected from a length of an implant, a width of the implant, a thickness of the implant the bone structure, a muscle density, or a combination thereof.
Date: December 07, 2023
Place: Noida

Dr. Keerti Gupta
Agent for the Applicant
(IN/PA-1529)