Guide Catheter Balloon Dilation Sinus Passageways
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Solution Overview
Problem
Current treatments for sinusitis, such as functional endoscopic sinus surgery (FESS), are invasive and can cause significant pain, bleeding complications, and may not be suitable for all patients due to the risk of re-obstruction from scar tissue, making alternative methods for treating constricted sinus passageways necessary.
Innovation Solution
A method involving the use of an elongate member with an inflation member, such as a balloon catheter, to expand constricted sinus passageways, and a system that includes a guide catheter and wire guide for accessing and visualizing the sinus cavity, allowing for dilation and remodeling of the sinus ostia without the need for extensive tissue removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If functional endoscopic sinus surgery (FESS) is performed to treat sinusitis, then sinus drainage is improved, but tissue trauma and post-operative pain increase
Solution Approach 1:
The patent changes the fundamental parameter of tissue interaction from cutting/removal to expansion/dilation. The balloon catheter applies controlled radial force to expand the sinus ostium and passageways, achieving improved drainage without the tissue trauma associated with surgical cutting instruments.
Solution Approach 2:
The patent replaces the mechanical cutting system (surgical instruments that cut and remove tissue) with a mechanical expansion system (balloon catheter that dilates and opens passageways). This substitution maintains the therapeutic effect of improved sinus drainage while eliminating the harmful tissue trauma.
2Reliability
If FESS surgery is performed to widen sinus outlets, then sinus drainage is improved, but bleeding complications and re-obstruction risk increase
Solution Approach 1:
The patent changes the surgical approach from tissue removal to tissue expansion. By inflating the balloon catheter within the sinus ostium, the procedure widens the drainage pathways without cutting blood vessels, thereby improving sinus drainage while eliminating bleeding complications.
Solution Approach 2:
The patent extracts the harmful element of tissue cutting from the surgical procedure. Instead of removing tissue with cutting instruments, the balloon catheter gently expands the existing tissue, taking out the source of bleeding complications while maintaining effective sinus drainage.
3Length of moving object
If surgical cutting instruments are used to treat sinus ostia, then sinus passage width is increased, but device complexity and invasiveness increase
Solution Approach 1:
The patent extracts the complex surgical cutting instruments and replaces them with a simple balloon catheter system. The balloon catheter can be inserted through the nasal passage and inflated to widen sinus ostia, achieving the same therapeutic effect with significantly reduced device complexity and invasiveness.
Solution Approach 2:
The patent changes the approach from mechanical cutting to pneumatic/hydraulic expansion. The balloon catheter uses fluid pressure to expand the sinus passageways, simplifying the device design while effectively increasing sinus passage width without the complexity of powered cutting instruments.
4Reliability
If traditional FESS surgery is performed, then sinus drainage is improved, but patient fear and treatment accessibility decrease
Solution Approach 1:
The patent changes the procedural parameters from general anesthesia and surgical cutting to local anesthesia and balloon expansion. This reduces patient fear and increases accessibility, as the procedure can be performed in an office setting rather than requiring an operating room and general anesthesia.
Solution Approach 2:
The patent extracts the frightening elements of traditional surgery (general anesthesia, cutting instruments, operating room setting) and replaces them with a less intimidating procedure using a balloon catheter that can be performed with minimal discomfort and in a familiar setting.
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 approach minimizes tissue trauma, reduces post-operative pain, and provides a less invasive means to confirm wire guide placement and expand sinus passageways, potentially offering a more effective and safer treatment for sinusitis than traditional surgical methods.
Implementation Method 1
The inflation member is then expanded so as to expand at least a portion of the constricted sinus passageway
Data Source
AI summary
A system for manipulating a guide catheter within a patient's nasal passages or sinus cavities includes a guide catheter formed from an elongate flexible member having a lumen passing there through. A wire guide is slidably disposed within the lumen of the guide catheter. The system further includes a steering member fixedly secured to a proximal end of the wire guide and a proximal hub secured to a proximal end of the guide catheter. The system further includes a recessed handle having a first recess for fixedly receiving the proximal hub of the guide catheter and a second recess for receiving the steering member, the second recess being dimensioned to permit axial and rotational movement of the steering member while disposed in the second recess.