Two-Part Settable Bone Hemostatic Adhesive With Lyophilized Plasma
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Solution Overview
Problem
There is a need for improved surgical materials that are moldable and suitable for hard and soft tissue repair, providing effective hemostasis and healing characteristics.
Innovation Solution
Compositions comprising previously unclotted human pooled or autologous plasma, prescreened for pathogens and optionally containing trehalose as a lyophilization stabilizer, are dried by lyophilization or simple evaporation and then cold-ground or -milled into a uniform particulate form, which can be added to moldable surgical implants, along with other components to provide exceptional bone, cartilage, and soft tissue hemostasis and healing characteristics.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If plasma is dried by lyophilization or evaporation and ground into particulate form, then the plasma particles remain active during ambient storage, but the processing complexity increases
Solution Approach 1:
The plasma is dried and ground into particles before storage, preparing it in advance for ambient storage conditions while maintaining activity. This preliminary processing allows the plasma to be stored without refrigeration while preserving its hemostatic properties.
Solution Approach 2:
The plasma undergoes phase changes from liquid to dried particulate form through lyophilization or evaporation. This parameter change in physical state enables ambient storage while maintaining biological activity, resolving the contradiction between storage conditions and material stability.
2Ease of operation
If moldable surgical implants are made from reactive liquids that cure in situ, then the implants can be delivered by minimally invasive means, but the control over final shape and properties becomes more difficult
Solution Approach 1:
The implant is divided into two separate components that are mixed at the time of use. This segmentation allows each component to be prepared with specific properties, then combined to form the final implant shape in situ, combining minimally invasive delivery with shape control.
Solution Approach 2:
The implant transitions from a flowable state during delivery to a cured solid state at the implant site. This dynamic state change allows the implant to be delivered through minimally invasive means while achieving the desired final shape and mechanical properties after curing.
3Reliability
If surgical materials contain multiple components including polymers, ceramics, and growth factors, then the healing characteristics are improved, but the device complexity increases
Solution Approach 1:
The plasma particles serve multiple functions simultaneously: they provide hemostasis through coagulation factors, promote healing through growth factors, and act as a carrier for the surgical implant. This multi-functionality reduces the need for separate components while maintaining comprehensive healing characteristics.
Solution Approach 2:
Multiple bioactive components including coagulation factors, growth factors, and healing promoters are merged into the plasma matrix. This combination creates a single integrated material that provides comprehensive healing characteristics without requiring separate delivery systems for each component.
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
The compositions provide instant hemostasis, are body absorbable, and maintain zones of inhibition against MRSA for at least 4 days, while being suitable for bone and soft tissue repair, including bone void fillers, bone cements, and soft tissue adhesives.
Implementation Method 1
previously unclotted human pooled or autologous plasma, prescreened for pathogens and optionally containing trehalose as a lyophilization stabilizer, could be dried by lyophilization or simple evaporation
Implementation Method 2
dried by lyophilization or simple evaporation
Data Source
AI summary
Provided herein are settable and non-settable compositions for use in surgical procedures comprising a variety of disclosed particles and optionally including previously unclotted, lyophilized, optionally crosslinked mammalian blood plasma. Also provided are related compositions, including surgical kits and packages, as well as methods of making and using the compositions.