Ventricular Partitioning Device Delivery System
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Solution Overview
Problem
There is a need for a new and effective system, device, and method to treat cardiac dysfunction, particularly in cases of congestive heart failure where elastic recoil forces are reduced, leading to impaired ventricular filling and increased filling pressure.
Innovation Solution
The development of a delivery system for an implantable ventricular partitioning device, which includes a delivery catheter, a sleeve, a mechanical seal, and a guide catheter, allows for the precise placement of a ventricular partitioning device within the heart. This device features a support frame with radially expandable struts and a membrane, designed to partition the ventricle, enhance elastic recoil, and improve ventricular function.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a delivery system is designed to precisely place a ventricular partitioning device, then device placement precision is improved, but system complexity increases due to multiple components (delivery catheter, sleeve, mechanical seal, guide catheter)
Solution Approach 1:
The delivery system employs a nested structure where the delivery catheter is inserted through the guide catheter, and the ventricular partitioning device is loaded within the delivery catheter. This nesting arrangement allows multiple functional components to be integrated in a compact configuration, enabling precise device placement while managing system complexity through spatial organization.
Solution Approach 2:
The mechanical seal acts as an intermediary component that forms a liquid-tight barrier between the delivery catheter and the external environment. This mediator enables controlled fluid delivery and maintains pressure gradients during device deployment, facilitating precise placement without requiring the entire system to be overly complex.
2Productivity
If fluid is delivered through the guide catheter at high pressure, then ventricular filling is enhanced, but risk of damage to cardiac tissue increases
Solution Approach 1:
The system utilizes hydraulic principles by delivering fluid through the guide catheter and delivery catheter to create pressure gradients that enhance ventricular filling. The mechanical seal ensures liquid-tight containment, allowing controlled pressure application that improves filling efficiency while the catheter design distributes pressure to minimize localized tissue damage.
Solution Approach 2:
The delivery system allows dynamic adjustment of fluid delivery parameters including pressure and flow rate. By controlling these parameters, the system can optimize ventricular filling efficiency while staying within safe pressure limits to prevent cardiac tissue damage, adapting to the patient's specific cardiac condition.
3Productivity
If the delivery catheter is made liquid-tight with a mechanical seal, then fluid delivery efficiency is improved, but ease of operation decreases due to sealing requirements
Solution Approach 1:
The mechanical seal serves as an intermediary that creates a liquid-tight barrier between the delivery catheter lumen and the external environment. This seal enables efficient fluid delivery by preventing leakage, while its design allows for controlled access and straightforward installation, balancing sealing effectiveness with operational simplicity.
Solution Approach 2:
The mechanical seal is designed to self-seal or maintain its sealing function automatically during device deployment. Once installed, the seal maintains liquid-tight containment without requiring continuous manual adjustment or complex operational procedures, thereby improving fluid delivery efficiency while preserving ease of operation during the critical deployment phase.
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 system effectively delivers and deploys the ventricular partitioning device, enhancing the heart's ability to fill during diastole, reducing end-diastolic volume and pressure, and increasing ejection fraction, thereby improving cardiac function in patients with heart failure.
Implementation Method 1
a mechanical seal coupled to the sleeve and configured to form a liquid-tight seal with the delivery catheter
Implementation Method 2
a first pressure in the guide catheter is greater than a second pressure in a ventricle when fluid is delivered through the guide catheter
Data Source
AI summary
A method of preparing a ventricular partitioning device for implantation using a delivery system can include coupling the ventricular partitioning device to a delivery catheter, loading the ventricular partitioning device and a portion of the delivery catheter into a sleeve and creating a liquid-tight seal between a portion of the sleeve and the delivery catheter, coupling a distal end of the sleeve to a guide catheter, and delivering fluid through at least one of the first fluid delivery port or the second fluid delivery port. The method can be performed with the delivery catheter or the sleeve having a first fluid delivery port positioned thereon. The method can be with the guide catheter having a second fluid delivery port positioned thereon.