Cryoablation Probe for Surgical Cavity Margin Treatment
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Solution Overview
Problem
Current radiation therapies for breast cancer, such as whole breast irradiation and brachytherapy, suffer from short and long-term complications like skin burns, tissue distortion, lymphedema, and secondary cancers, and are costly, necessitating a more targeted and effective treatment for the surgical cavity margin.
Innovation Solution
A fixed probe system delivering cryogenic energy to the surgical cavity using materials like stainless steel and cryogenic fluids, such as nitrous oxide or liquid nitrogen, to ablate or necrotize remaining cancerous cells, optionally with a suction path for improved contact and thermal monitoring for precise isotherm control.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If radiation therapy (whole breast irradiation or brachytherapy) is used to treat the surgical cavity margin, then cancer cells are eradicated, but serious short and long-term complications occur including skin burns, tissue distortion, lymphedema, and secondary cancers
Solution Approach 1:
The patent applies local quality by using cryoablation to treat only the specific surgical cavity margin where cancer cells may remain, rather than irradiating the entire breast. The cryoprobe is positioned directly at the cavity margin to deliver localized freezing therapy, concentrating the therapeutic effect precisely where needed while leaving surrounding healthy tissue unaffected.
Solution Approach 2:
The patent substitutes the radiation therapy mechanism with a mechanical cryoablation system. Instead of using ionizing radiation, the invention employs a cryoprobe that mechanically freezes and ablates cancer cells through controlled cooling, phase change of cryogenic fluid, and thermal conduction to the target tissue.
2Ease of operation
If brachytherapy is used to deliver focused radiation therapy, then treatment is convenient and clinically effective, but the costs to the healthcare system are especially costly
Solution Approach 1:
The patent changes the fundamental parameter of the treatment modality from radiation-based to temperature-based therapy. By using cryogenic temperatures achieved through phase change of liquid nitrogen or other cryogenic fluids, the system provides focused therapy with different physical mechanisms that are less costly to implement and maintain compared to radiation therapy infrastructure.
3Manufacturing precision
If experimental energy forms (high intensity focused ultrasound, laser, microwave, cryoablation) are used to treat the surgical cavity, then a more targeted approach is achieved, but the technologies are in experimental states with unknown long-term outcomes
Solution Approach 1:
The patent utilizes phase transitions of cryogenic fluids (liquid to gas) to achieve controlled freezing of cancer cells. The phase change provides a reliable and predictable mechanism for energy transfer and tissue freezing, with well-understood thermodynamic principles that ensure consistent therapeutic outcomes.
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
This method effectively treats the surgical cavity margin with reduced side effects and procedural time, minimizing tissue damage and potential for secondary cancers while offering a cost-effective alternative to traditional radiation therapies.
Implementation Method 1
a selected cryogenic agent is administered through a channel into one or more discrete channels affixed to the surface of the probe for supplying cryogenic energy to the surface of the fixed probe and removing energy from the surrounding tissue
Implementation Method 2
The cryogenic fluid delivery system may be as simple as a handheld fluid delivery device or as complicated as a microprocessor controlled closed loop fluid delivery system depending on the selected cryogenic fluid. Typically, the cooling system will comprise a Joule-Thompson effect cooler or other system that relies on expansion and phase change of a liquid passing through a valve.
Implementation Method 3
Typically, the cooling system will comprise a Joule-Thompson effect cooler or other system that relies on expansion and phase change of a liquid passing through a valve
Implementation Method 4
The interior of the hollow member may be at atmospheric pressure or at a vacuum to assist in insulating the interior of the fixed probe to maximize thermal energy transfer to the surrounding tissue
Implementation Method 5
The interior of the hollow member may be at atmospheric pressure or at a vacuum to assist in insulating the interior of the fixed probe
Implementation Method 6
Another embodiment of the fixed probe system for supplying cryogenic energy to the breast tumor cavity optionally incorporates a suction path between exterior of the tissue contacting exterior surface fixed probe element and the tissue cavity
Data Source
AI summary
A probe for ablating a marginal tissue region in a surgically created tissue cavity includes a shaft having a shell with an exterior heat transfer surface mounted on a distal region of the shaft. At least one temperature sensor is provided on the exterior heat transfer surface of the shell, and the exterior heat transfer surface contacts at least a portion of an inner surface of the surgically created tissue cavity when placed therein. A cryogenic system supplies cryogenic fluid to a supply lumen and removes the fluid through separate fluid removal lumen in the shaft.