Patent Application
20240399023
The invention relates to a polydioxanone (“PDS”) composite coated magnesium calcium phosphate composite alloy for orthopedic implants.
Titanium and 316L stainless steel have been the mainstay metals for orthopedic implants for over a 100 years. Nickel allergies and seeking more biocompatible implants has led to titanium superseding 316L SS. One drawback is that both materials have no dynamic capabilities which leads to stress shielding and the potential to cause bones to not heal. Also the increasing trend to removal of orthopedic implants has led to a huge burden on the orthopedic resources in many countries.
It would be beneficial to develop a PDS composite coated magnesium alloy implant to: aid in stability of any bone healing environment; dynamically change with the environment to allow the bone healing environment to exhibit more load as the bone heals; ultimately absorb into the surrounding bone tissue to avoid removal; produce an osteoblastic environment which promotes bone healing rather then cause a static environment; and reduce the incidence of a burst or rebound Osteoclastic event by controlling the elution of Mg into the environment.
This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.
In one embodiment, the present invention provides a polydioxanone composite coated magnesium calcium phosphate composite alloy for orthopedic implants. Implants manufactured from the alloy composite are also provided.
In another embodiment, the present invention provides a polyglyconate (co-polymer of Glycolic Acid & Trimethylene Carbonate) composite coated magnesium calcium phosphate composite alloy for orthopedic implants. Implants manufactured from the alloy composite are also provided.
The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate the presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain the features of the invention. In the drawings:
In the drawings, like numerals indicate like elements throughout. Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. The terminology includes the words specifically mentioned, derivatives thereof and words of similar import. The embodiments illustrated below are not intended to be exhaustive or to limit the invention to the precise form disclosed. These embodiments are chosen and described to best explain the principle of the invention and its application and practical use and to enable others skilled in the art to best utilize the invention.
Reference herein to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment can be included in at least one embodiment of the invention. The appearances of the phrase “in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments necessarily mutually exclusive of other embodiments. The same applies to the term “implementation.”
As used in this application, the word “exemplary” is used herein to mean serving as an example, instance, or illustration. Any aspect or design described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other aspects or designs. Rather, use of the word exemplary is intended to present concepts in a concrete fashion.
The word “about” is used herein to include a value of +/−10 percent of the numerical value modified by the word “about” and the word “generally” is used herein to mean “without regard to particulars or exceptions.”
Additionally, the term “or” is intended to mean an inclusive “or” rather than an exclusive “or”. That is, unless specified otherwise, or clear from context, “X employs A or B” is intended to mean any of the natural inclusive permutations. That is, if X employs A; X employs B; or X employs both A and B, then “X employs A or B” is satisfied under any of the foregoing instances. In addition, the articles “a” and “an” as used in this application and the appended claims should generally be construed to mean “one or more” unless specified otherwise or clear from context to be directed to a singular form.
Unless explicitly stated otherwise, each numerical value and range should be interpreted as being approximate as if the word “about” or “approximately” preceded the value of the value or range.
The use of figure numbers and/or figure reference labels in the claims is intended to identify one or more possible embodiments of the claimed subject matter in order to facilitate the interpretation of the claims. Such use is not to be construed as necessarily limiting the scope of those claims to the embodiments shown in the corresponding figures.
It should be understood that the steps of the exemplary methods set forth herein are not necessarily required to be performed in the order described, and the order of the steps of such methods should be understood to be merely exemplary. Likewise, additional steps may be included in such methods, and certain steps may be omitted or combined, in methods consistent with various embodiments of the present invention.
Although the elements in the following method claims, if any, are recited in a particular sequence with corresponding labeling, unless the claim recitations otherwise imply a particular sequence for implementing some or all of those elements, those elements are not necessarily intended to be limited to being implemented in that particular sequence.
The present invention provides a polydioxanone ((C4H6O3)n) composite coated magnesium calcium phosphate composite alloy for orthopedic implants that includes a magnesium alloy coated with a polydioxanone composite.
In an exemplary embodiment, the magnesium alloy comprises or alternatively consists essentially of:
The polydioxanone composite also includes an adhesive to adhere the polydioxanone composite to the magnesium alloy. Exemplary adhesives can be fibrin, phospherine, and dopamine. In an exemplary embodiment, the polydioxanone composite coating is between about 0.05 mm and about 1.5 mm thick. The inventor has found that layers greater than 1.5 mm thick have a tendency to peel off the magnesium alloy base composite material.
In an alternative embodiment, a glycolide/trimetheylene carbonate (polyglyconate) polymer coating can be applied to the magnesium alloy.
In an exemplary embodiment, the alloy forms an implant, such as a wire, an intermedullary nail, a fixation nail, an osteotomy a wedge, a screw, and a plate. Exemplary wedges are foot & ankle wedges, such as a Cotton Wedge, an Evans Wedge, and a distal tibial osteotomy (DTO) wedge. Other exemplary wedges are a knee wedge, a distal femoral wedge, and a high tibial osteotomy (HTO) wedge. All implants have rounded off edges.
Referring to
The through passages 104 are 50-90% covered by the polydioxanone/polyglyconate composite so the magnesium alloy becomes exposed quicker to allow bone expansion. The infinity sign shape of through passages 104 enables double pillar bone growth, which aids in stronger bone struts with the initial healing phase. These pillar structures expand as the magnesium is absorbed by the body to allow for bone growth. The magnesium alloy has OCP and DCPD mixed in, which promotes bone growth as the alloy absorbs, while delaying its absorption by the body.
It will be further understood that various changes in the details, materials, and arrangements of the parts which have been described and illustrated in order to explain the nature of this invention may be made by those skilled in the art without departing from the scope of the invention as expressed in the following claims.
| Number | Date | Country | |
|---|---|---|---|
| 63470192 | Jun 2023 | US |
