Thermosensitive Polymer Tract Sealant for Pneumothorax Prevention
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Solution Overview
Problem
Current methods for preventing pneumothorax during lung biopsies, such as CT-guided biopsies, face challenges due to the risk of air entering the pleural space, leading to complications like collapsed lungs, and existing sealing solutions like BioSentry's desiccated PEG-hydrogel plugs have limitations in volumetric expansion and length, failing to immediately prevent air entry upon biopsy device insertion.
Innovation Solution
A delivery device that administers a thermosensitive polymer, like poloxamers or pluronic, which changes from a liquid to a gel state at body temperature, is used to seal the tract before and after the biopsy, creating a physical barrier to prevent air and fluid flow, thereby reducing the risk of pneumothorax.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a desiccated PEG-hydrogel plug is used to seal the tract, then some sealing effect is achieved, but the volumetric expansion and length are insufficient to immediately prevent air entry upon biopsy device insertion
Solution Approach 1:
The patent applies parameter changes by utilizing the thermosensitive property of the polymer to change its physical state from liquid to gel in response to temperature changes. The polymer is injected as a liquid at room temperature for easy delivery, then transforms into a gel at body temperature to provide immediate sealing. This parameter change resolves the contradiction by enabling the sealant to achieve sufficient length and volume expansion without requiring a longer initial plug structure.
Solution Approach 2:
The patent employs phase transitions by using a thermosensitive polymer that undergoes a liquid-to-gel phase transition at body temperature. This phase change allows the sealant to immediately increase in volume and form a stable gel barrier upon injection, providing sufficient length and sealing effectiveness without requiring a pre-formed long plug structure. The phase transition directly addresses the limitation of insufficient plug length in existing sealing solutions.
2Reliability
If a thermosensitive polymer is used to seal the tract, then immediate prevention of air entry is achieved, but the device complexity increases due to the need for temperature-sensitive material properties
Solution Approach 1:
The patent applies self-service by using a thermosensitive polymer that automatically transforms from liquid to gel in response to the body temperature environment. The material self-regulates its physical state without requiring external control mechanisms, complex delivery systems, or additional components. This self-service property resolves the contradiction by achieving immediate sealing through the material's inherent temperature-responsive behavior, thereby avoiding increased device complexity.
Solution Approach 2:
The patent replaces mechanical sealing systems with a chemically-responsive material system. Instead of using mechanically complex devices with moving parts or multi-component systems to achieve sealing, the invention uses a thermosensitive polymer that responds to thermal conditions. This substitution of mechanical complexity with chemical/physical material properties achieves immediate sealing while maintaining simplicity in the overall device design.
3Ease of operation
If the polymer is administered in liquid form, then easy injection is achieved, but the sealing effectiveness is reduced compared to gel state administration
Solution Approach 1:
The patent applies preliminary action by preparing the polymer in liquid form at room temperature for easy injection, then allowing it to automatically transform into a gel state after injection when exposed to body temperature. This preliminary liquid state facilitates simple injection without requiring complex delivery mechanisms, while the subsequent gel formation provides effective sealing. The preliminary action resolves the contradiction by separating the injection phase (liquid) from the sealing phase (gel).
Solution Approach 2:
The patent uses parameter changes by exploiting the temperature-dependent physical state transition of the thermosensitive polymer. The polymer is administered in liquid form at room temperature for ease of injection, then undergoes a parameter change to gel state at body temperature to provide effective sealing. This parameter change resolves the contradiction by enabling both easy injection and effective sealing through the same material in different physical states.
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 thermosensitive polymer effectively seals the tract during and after the biopsy, significantly reducing the incidence of pneumothorax by forming a stable gel barrier that maintains its integrity throughout the procedure and post-procedure, as demonstrated in in-vivo models.
Implementation Method 1
A delivery device that administers a thermosensitive polymer, like poloxamers or pluronic, which changes from a liquid to a gel state at body temperature
Data Source
AI summary
This disclosure relates to devices, method, and material compositions. Specifically, the present invention related to a delivery device to deliver a material composition that seals a tract, for example during a percutaneous intervention.