Cryo-perfusion Balloon for Localized Vascular Cooling
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Solution Overview
Problem
Existing methods for treating vascular occlusions often result in excessive and undesirable systemic cooling, which is not effective in limiting ischemic damage to specific regions of the body, as they require cooling large portions of the patient's body.
Innovation Solution
A medical device with an elongate body and expandable elements that can be positioned near a vascular occlusion, allowing for localized cooling and perfusion, using a perfusion path and fluid control elements to deliver cooled fluid and reduce tissue temperature specifically at the occlusion site.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Temperature
If systemic hypothermia is applied to treat vascular occlusion, then the metabolic rate of the affected tissue is reduced, but large portions of the patient's body are cooled excessively and undesirably
Solution Approach 1:
The patent applies local cooling by positioning a cooling device directly at the site of vascular occlusion within the vascular system, rather than cooling the entire body. The cooling medium is delivered through a catheter or similar device that targets only the affected region, thereby reducing metabolic rate locally without causing systemic hypothermia and its associated risks.
Solution Approach 2:
The patent segments the cooling function from the entire body system and isolates it to the specific vascular region affected by occlusion. By using a localized delivery system (catheter, balloon, or perfusion device), the cooling effect is confined to the affected tissue segment, preventing unnecessary cooling of other body parts.
2Productivity
If invasive surgery is performed to treat vascular occlusion, then blood flow restriction is relieved, but tissue temperature control during the procedure is compromised
Solution Approach 1:
The patent combines the vascular intervention procedure with simultaneous local cooling therapy. The cooling device is integrated into the surgical approach, allowing blood flow restoration and temperature control to occur concurrently. This merging of functions provides both therapeutic benefits without requiring separate procedures.
Solution Approach 2:
The patent applies cooling therapy before, during, or immediately after vascular intervention to preemptively protect tissue from ischemic damage. By establishing temperature control in advance or concurrently with the surgical procedure, the tissue is protected during the critical period of blood flow disruption.
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 device effectively reduces ischemic damage by selectively cooling and perfusing the affected tissue region, minimizing systemic cooling and its associated risks.
Implementation Method 1
the expandable element may thermally affect tissue surrounding the expandable element
Implementation Method 2
the coolant may further thermally affect at least a portion of the perfusion path
Implementation Method 3
The fluid control element may subsequently be actuated or otherwise engaged to deliver cooled fluid through the perfusion path and downstream of the occlusion
Data Source
AI summary
The present invention provides a method and apparatus for treating a vascular occlusion and preventing or reducing ischemic consequences of such an obstruction. The medical device of the present invention may include an elongate body defining a proximal end and a distal end, where the elongate body may also define an injection lumen, an exhaust lumen, and a guidewire lumen. A first expandable element may be coupled to the elongate body, where the first expandable element is in fluid communication with the injection lumen and the exhaust lumen. Further, a perfusion path may be disposed within the elongate body, and a sheath may be movably disposed about at least a portion of the elongate body. The medical device may further include a second expandable element disposed about the elongate body, as well as second inflation and exhaust lumens.