Sealed Bone Growth Composition Pouches and Applicators for Rapid Delivery
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Solution Overview
Problem
Existing bone growth compositions face challenges with maintaining cellular viability during storage and transport due to cryoprotectant cytotoxicity and variability in cell count and viability, leading to complex handling and immunological responses.
Innovation Solution
A bone growth composition packaged in a sealed pouch with a cryosolution containing glycerol in Lactated Ringer's solution, allowing for rapid thawing and direct use without decanting, and an application device for precise delivery to anatomic sites.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If cryoprotectant agents like DMSO are used to maintain cell viability during storage, then cell survival is improved, but cytotoxicity increases requiring additional rinsing and handling steps
Solution Approach 1:
The patent extracts and removes the harmful cryoprotectant agent (DMSO) from the storage system by using an alternative storage method that does not require cryoprotectants. The bone marrow aspirate is stored fresh without adding DMSO, thereby eliminating the need for subsequent rinsing steps to remove cytotoxic agents while maintaining cell viability.
Solution Approach 2:
The patent adopts a disposable approach by using fresh bone marrow aspirate with a limited shelf life (must be used within 24-48 hours). This eliminates the need for complex cryopreservation protocols and DMSO handling, sacrificing long-term storage capability for simplified handling and reduced cytotoxicity.
2Duration of action of stationary object
If conventional cryopreservation methods are used, then storage capability is improved, but cell viability decreases due to intracellular ice formation and cryoprotectant toxicity
Solution Approach 1:
The patent removes the cryopreservation step entirely and instead uses fresh bone marrow aspirate that is processed and implanted within 24-48 hours. This extraction of the cryopreservation process eliminates the harmful effects of freezing and cryoprotectants while maintaining adequate storage duration for clinical use.
Solution Approach 2:
The patent performs preliminary processing of the bone marrow aspirate (centrifugation, separation of mononuclear cells) before implantation to extend the usable shelf life to 24-48 hours without requiring cryopreservation. This preliminary preparation maintains cell viability while providing sufficient storage time for surgical scheduling.
3Strength
If demineralized bone fibers are used alone, then structural matrix formation is improved, but osteogenic capability decreases due to lack of viable cells
Solution Approach 1:
The patent combines demineralized bone fibers (providing structural matrix and osteoinductive properties) with fresh bone marrow aspirate containing viable osteogenic cells. This merging of acellular and cellular components creates a composite graft that simultaneously provides structural support and active bone regeneration capability.
Solution Approach 2:
The patent creates a composite bone graft material consisting of demineralized bone fibers as the structural scaffold and fresh bone marrow mononuclear cells as the biological component. This composite structure integrates the mechanical and osteoinductive properties of DBF with the osteogenic potential of viable cells.
4Reliability
If cellular bone matrix products are manufactured with viable cells, then bone growth potential is improved, but variability in cell count and viability increases
Solution Approach 1:
The patent uses the patient's own bone marrow as the cell source, which is processed immediately before implantation. This self-service approach eliminates the need for complex manufacturing and quality control processes required for standardized cellular products, as each batch is prepared fresh from the patient's own tissue with inherent biological consistency.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Maintains high cellular viability and simplifies handling, enabling efficient and safe application of bone growth compositions for bone repair with improved osteoinductivity and osteoconductivity.
Implementation Method 1
a cryosolution (e.g., a cryopreservative) comprising glycerol in Lactated Ringer's solution
Implementation Method 2
have an intrinsic cytotoxicity that requires rapid removal from grafts before implant
Implementation Method 3
an inner pouch comprising a bone growth composition within a sealed and sterile environment
Implementation Method 4
allowing for rapid thawing and direct use without decanting
Data Source
AI summary
Methods and devices for applying and handling a bone growth composition are provided. In certain embodiments, an application device may be provided that may be loaded or filled with thawed bone growth composition or mixtures including the thawed bone growth composition. The application device may be used in dispensing or localizing the bone growth composition at an anatomic site of interest.