Compositions and methods for adhesion to surfaces

Inventors

Hess, Brian J.Kay, George W.

Assignees

Revbio Inc

Publication Number

US-12178937-B2

Publication Date

2024-12-31

Expiration Date

2036-05-27

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Abstract

The present disclosure features adhesive compositions and methods of use thereof related to the medical, veterinary, and dental fields.

Core Innovation

The invention described presents adhesive compositions and methods for their use, primarily focused on the medical, veterinary, and dental fields. The core composition includes a multivalent metal salt (such as alpha tricalcium phosphate), an organic phosphate compound of Formula (I) (including phosphoserine), and an aqueous medium. These compositions exhibit properties allowing them to adhere to surfaces like bone or devices, can be molded or shaped before hardening, and form a solid, cement-like structure upon setting.

The background section identifies that conventional fixation methods for bony structures rely heavily on mechanical means—such as screws, pins, and bone cements—that require sufficient bone volume and density. These existing methods are especially limited when bone quality is poor due to anatomical, traumatic, or disease-related factors. There is a need for adhesive-based fixation that does not depend exclusively on mechanical engagement with healthy bone, and that can maintain or augment bone volume, provide a barrier against fluid leakage, and facilitate integration or replacement by natural bone.

This disclosure solves the stated problems by providing adhesive compositions that can be injected, flowed, or molded onto or into bone, bone defects, or onto devices, where they rapidly cure or harden (often within 30 minutes or less), adhere to both biological and non-biological surfaces, and can be engineered to be bioresorbable, allowing biological replacement by bone while maintaining volume. The invention enables various processes, including joining bone fragments, filling bone voids, affixing implants and devices, and creating barriers against fluids or microbial ingress, broadening clinical possibilities for bone repair and augmentation.

Claims Coverage

The patent contains two independent claims, each providing key inventive features for injectable adhesive compositions suitable for medical, dental, and orthopedic uses.

Injectable adhesive composition comprising alpha tricalcium phosphate, an organic phosphate compound of Formula (I), and an aqueous medium

The composition is injectable and comprises: - Alpha tricalcium phosphate provided as a powder with a mean particle size between 0.001 mm and 0.150 mm - An organic phosphate compound of Formula (I) - An aqueous medium (5% to 50% w/w of the composition) - The viscosity of the composition is between 100 cP and 10,000 cP in the fluid state. The composition may include further components and features such as: - The organic phosphate is present within the adhesive composition - The possibility for the organic phosphate to be phosphoserine This composition forms an adhesive for bone and device applications.

Injectable adhesive composition comprising alpha tricalcium phosphate, phosphoserine, and an aqueous medium with defined ratios and powder particle size

This composition consists of: - Alpha tricalcium phosphate in an amount between 15% and 85% (w/w) of the composition - Phosphoserine in an amount between 10% and 90% (w/w) of the composition - Aqueous medium between 10% and 35% (w/w) of the composition - Viscosity between 100 cP and 10,000 cP in the fluid state - Alpha tricalcium phosphate provided as a powder with a particle size between 0.001 mm and 0.025 mm The composition is designed to be injectable and hardens to form a strong adhesive bond.

Both claims cover compositions characterized by defined ratios and particle sizes, fluid injectability with controlled viscosity, and the use of alpha tricalcium phosphate and an organic phosphate (including phosphoserine) in the presence of an aqueous medium. The inventive features enable the compositions to be used as adhesives for bone fixation, void filling, and similar medical applications.

Stated Advantages

The adhesive composition can adhere to bone and device surfaces, providing fixation without relying solely on mechanical friction or bone density.

The composition can be molded, flowed, or deformed before hardening, allowing precise adaptation to the application site.

Upon hardening, the material forms a strong solid that supports load-bearing and provides mechanical stability.

Certain embodiments are bioresorbable and allow biological processes to replace the material with natural bone over time, maintaining the original volume (space maintenance).

The adhesive can be applied in wet fields, including in the presence of blood or other fluids, without losing efficacy.

Curing or hardening occurs rapidly (often within 30 minutes or less), enabling efficiency and convenience during clinical procedures.

The adhesive composition can serve as a seal, preventing fluid or microbial ingress at the application site.

Additives can be included to modify physical properties, biological response, or deliver medications locally.

The compositions can achieve clinically meaningful adhesive strengths sufficient for fixation and load-bearing uses.

Documented Applications

Fixation of structures (bone, implants, devices, grafts) to bone in medical, dental, and veterinary procedures.

Adhesive joining of bone fragments or bone segments, including for fracture repair, congenital defects, and reconstructive procedures.

Filling voids, gaps, or defects in bone caused by trauma, cyst removal, disease, or surgery.

Augmenting bone volume for purposes such as ridge augmentation in dental implantology, sinus lifts, and onlay grafts.

Affixing dental devices to teeth or bone, including posts, crowns, and partial dentures.

Repairing defects in teeth, including restoration after decay or injury, and pulp capping.

Sealing gaps between devices (such as prosthetic abutments, crowns, or prosthetic limbs) and their retaining implants or bone to prevent fluid or microbial ingress.

Providing temporary or permanent seals or barriers in wounds, fistulae, or at sites of bone injury to prevent fluid leakage or infection.

Controlling excessive bleeding from bone wounds or fractures, including in urgent and surgical settings.

Additive reshaping, molding, or contouring of bone surfaces for cosmetic or reconstructive purposes, including in the facial region.

Preparation and installation of bone grafts or composites for further implantation or tissue engineering.

Adhesive stabilization and fixation in spinal fusion procedures, joint bridging, or vertebral body support.

Repairing or reinforcing bone or calcified tissue defects in subjects with disease, trauma, or congenital conditions affecting bone integrity (e.g., osteosarcoma, osteoporosis, osteogenesis imperfecta, fibrous dysplasia).

Use in non-human animals for repairing defects, fractures, or adhesively joining skeletal structures, and in non-vertebrate animal structures such as corals.

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