Balloon Brachytherapy Applicator with Removable Sheath
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Solution Overview
Problem
Current balloon brachytherapy applicators pose risks of infection and discomfort due to prolonged exposure of the surgical wound and disturbance of sensitive anatomy, as they often require extended periods with apparatus protruding through the skin before and during radiation therapy.
Innovation Solution
An expandable balloon apparatus is placed within the tumor resection cavity intraoperatively, allowing the skin to be closed for healing, with a hollow sheath providing access for radiation treatment and facilitating the insertion of a radiation source without the need for prolonged skin exposure, incorporating channels for inflation, anesthetic delivery, or drainage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the balloon applicator is placed intraoperatively and remains indwelling for an extended period, then access to the excision cavity is maintained, but the risk of infection increases and patient discomfort increases
Solution Approach 1:
The applicator is divided into two segments: a permanent sheath that remains implanted in the excision cavity and a removable balloon component that can be inserted and removed as needed. This segmentation allows the sheath to maintain access to the cavity while the balloon can be removed to eliminate infection risk during prolonged indwelling periods.
Solution Approach 2:
The sheath is placed intraoperatively during surgery to establish access to the excision cavity before radiation therapy is needed. This preliminary placement allows the cavity to be accessed later without requiring re-incision, while the sheath remains in place to maintain access throughout the extended period between surgery and radiation treatment.
2Ease of operation
If the balloon applicator is placed intraoperatively and remains indwelling for an extended period, then access to the excision cavity is maintained, but patient discomfort increases
Solution Approach 1:
By separating the applicator into a permanent sheath and removable balloon components, the design allows the balloon to be removed when not in use, eliminating the discomfort of having an extended apparatus indwelling in the body cavity while maintaining access capability through the sheath.
Solution Approach 2:
The applicator system transitions from a static indwelling balloon to a dynamic system where the balloon can be inserted and removed as needed. This dynamic capability allows the system to adapt between providing access and eliminating discomfort based on clinical requirements.
3Object-affected harmful factors
If a separate access site is created for radiation therapy, then sensitive tissue structures are protected, but the complexity of the procedure increases
Solution Approach 1:
The sheath serves multiple functions: it provides access to the excision cavity for radiation therapy, protects sensitive tissue structures by allowing controlled access, and can be removed or adjusted as needed. This multi-functionality eliminates the need for separate access sites while maintaining protection of sensitive tissues.
Data Source
AI summary
Methods and applicator apparatus are disclosed for brachytherapy treatment of tissue surrounding a cavity in a patient, particularly a resection cavity. In treatment regimes requiring recovery time between successive radiation treatments, applicators of the invention are retained under the skin, with the skin allowed to at least partially heal, and are re-accessed later for one or more subsequent treatments. To reduce patient discomfort an anesthetic agent can be infused through the applicator to patient tissue, for insertion, balloon inflation or removal of the applicator.