Integrated Dilator Balloon Transseptal Puncture
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Solution Overview
Problem
Current transseptal procedures face challenges with prolonged procedure times and increased risk of complications due to the need to exchange devices for additional dilation, as existing devices may struggle to cross the atrial septum effectively.
Innovation Solution
A dilator with an expandable membrane or element that transitions from a deflated state for delivery through a sheath to an inflated state for enhanced dilation, allowing for improved access and potential integration with a radiofrequency perforation device for precise tissue penetration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a stiff elongated needle (Brockenbrough Needle) is used to puncture the atrial septum, then puncture capability is achieved, but additional device exchange is required for supplemental dilation
Solution Approach 1:
The patent combines the puncture needle and dilation balloon into a single integrated device. The Brockenbrough needle is incorporated as the distal tip of the dilator body, while the balloon is positioned proximal to the needle. This merging eliminates the need for separate device exchanges between puncture and dilation steps, resolving the technical contradiction between achieving reliable puncture and avoiding device exchange complexity.
Solution Approach 2:
The device employs a nested structure where the balloon is disposed within the dilator body, and the Brockenbrough needle is integrated at the distal end. The balloon can be collapsed during delivery through the sheath and then expanded at the target site. This nesting allows multiple functions (puncture and dilation) to be contained within a single deployable device, eliminating the need for sequential device exchanges.
2Reliability
If device exchange is performed for supplemental dilation, then dilation capability is improved, but procedure time increases
Solution Approach 1:
The patent merges the puncture function and dilation function into a single device that can perform both operations sequentially without removal or exchange. The Brockenbrough needle provides the puncture capability while the integrated balloon provides the dilation capability, both accessible through one device platform. This eliminates the time-consuming device exchange step while maintaining both puncture and dilation capabilities.
Solution Approach 2:
The device is designed and delivered in a collapsed or compressed state through the sheath, with the balloon pre-positioned but not yet expanded. The puncture needle is already in place at the distal tip. This preliminary preparation allows the device to be delivered ready-to-use, and upon deployment, the balloon can be immediately inflated for dilation without waiting for device exchange, thereby reducing procedure time.
3Reliability
If device exchange is performed for supplemental dilation, then dilation capability is improved, but risk of complications increases
Solution Approach 1:
The patent combines multiple functions (puncture, dilation, and sheath delivery) into a single integrated device system. By eliminating the need for device exchange between puncture and dilation steps, the system removes the additional risks associated with manipulating multiple devices, potential loss of access, and prolonged procedural exposure. The integrated design maintains reliable dilation capability while reducing complication risks.
Solution Approach 2:
The device is delivered in a protected, collapsed state within the sheath, with all functional components (needle, balloon) pre-positioned and secured. This preliminary configuration minimizes the time the device is exposed in the vascular system and reduces the opportunity for complications during device manipulation. Once deployed, the balloon can be immediately inflated to achieve dilation without requiring additional device exchanges that would increase complication risk.
4Reliability
If a larger transseptal device is used for supplemental dilation, then dilation effectiveness is improved, but difficulty crossing the septum increases
Solution Approach 1:
The device employs a dynamic structure where the balloon can transition from a collapsed delivery state to an expanded working state. During delivery and septum crossing, the balloon remains collapsed, allowing the device to navigate through the sheath and puncture the septum with the same profile as a standard needle. Once positioned, the balloon expands to provide the larger diameter needed for effective dilation and subsequent sheath deployment, thus achieving both ease of crossing and effective dilation.
Solution Approach 2:
The device uses a nested configuration where the larger dilation balloon is contained within the delivery system during the crossing phase. The balloon is disposed within the dilator body in a collapsed state, allowing the entire assembly to pass through the sheath and cross the septum without the profile constraints of a fully expanded balloon. After successful crossing and positioning, the balloon is then expanded to provide the necessary dilation effectiveness for larger therapy sheath deployment.
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 expandable dilator facilitates safer and more efficient access to the heart by providing supplemental dilation without the need for device exchange, reducing procedure time and complications, and enabling the use of larger therapy sheaths.
Implementation Method 1
The inner region of the membrane is in fluid communication with the dilator lumen. The dilator lumen may deliver the external fluid source to the expandable membrane.
Data Source
AI summary
A dilator for facilitating access to a patient's heart and for coupling with a sheath including a sheath hub is disclosed. The dilator includes a dilator body having a proximal end portion and an opposite distal end portion, the distal end portion having a tapered tip portion, the body having a cylindrical wall defining an inner surface and an outer surface, the inner surface defining a dilator lumen extending through an entire length of the body. The dilator further includes an expandable membrane disposed over the body in the distal end portion, the membrane having an inner region in fluid communication with the dilator lumen.