Retrievable Interatrial Shunt With Adjustable Flow Control
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Solution Overview
Problem
Implanted interatrial shunts can cause complications such as distortion of the interatrial septum, cardiac arrhythmias, inability to use the transseptal approach for future interventions, paradoxical embolism, and blood desaturation, making them unsuitable for temporary use.
Innovation Solution
A temporary shunting apparatus with extendable wires and a sheath mechanism that allows the shunt to be collapsed and removed easily, and adjustable diameter regulation using flexible longitudinal elements, enabling placement and removal within a short period.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an implanted interatrial shunt is used to treat pulmonary hypertension or congestive heart failure, then decompression of the atrium is achieved, but complications such as distortion of the interatrial septum, cardiac arrhythmias, inability to use the transseptal approach for future interventions, paradoxical embolism, and blood desaturation occur
Solution Approach 1:
The shunt device incorporates an adjustable diameter mechanism that allows the opening size to be modified after implantation. This dynamic adjustment capability enables clinicians to optimize decompression effectiveness while minimizing complications by tailoring the shunt opening to the patient's specific needs and monitoring results over time.
Solution Approach 2:
The invention changes the physical parameter of the shunt opening diameter from fixed to variable. By providing a mechanism to alter the diameter parameter post-implantation, the system can adapt to changing patient conditions and reduce harmful effects associated with fixed-size implants.
2Ease of manufacture
If a fixed diameter shunt is implanted, then decompression is provided, but the shunt cannot be adjusted if patient conditions change
Solution Approach 1:
The shunt incorporates a dynamic adjustment mechanism that allows the diameter to be changed after implantation. This enables the device to adapt to changing patient conditions while maintaining the initial decompression function.
Solution Approach 2:
The shunt device serves multiple functions: initial decompression, adjustable flow regulation, and long-term adaptability. The inclusion of an adjustment mechanism transforms a single-function fixed shunt into a multi-functional device that can respond to various clinical scenarios.
3Duration of action of stationary object
If an implanted shunt is placed for long-term treatment, then chronic decompression is achieved, but removal or retrieval becomes difficult
Solution Approach 1:
The invention provides a mechanism for extracting or removing the shunt device after implantation. The adjustment mechanism includes components that can be accessed and manipulated from outside the body, allowing for shunt diameter modification or complete device removal when treatment is no longer needed or complications arise.
4Productivity
If a shunt with larger opening is used to ensure adequate decompression, then blood flow is improved, but risk of paradoxical embolism and blood desaturation increases
Solution Approach 1:
The adjustable diameter mechanism allows clinicians to start with a larger opening to ensure adequate decompression and blood flow, then gradually reduce the opening size as the patient's condition improves. This dynamic control minimizes the risk of paradoxical embolism and blood desaturation while maintaining sufficient decompression effectiveness.
Solution Approach 2:
The adjustable shunt design enables continuous monitoring and adjustment based on patient response. Clinicians can monitor blood flow, decompression effectiveness, and signs of complications, then adjust the shunt diameter accordingly to maintain optimal therapy while minimizing harmful effects.
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
Facilitates temporary shunting without long-term complications, allowing easy retrieval and adjustable flow control, addressing the limitations of implanted shunts.
Implementation Method 1
a shunt (56) made from a shape memory alloy and having a predetermined open configuration
Implementation Method 2
The shunt can be compressed into a reduced diameter size for insertion into and removal from a body passageway
Data Source
Figure 1
Figure 2
Figure 3A~3B
AI summary
Described embodiments include apparatus (28) that includes a shunt (26). The shunt includes a flared distal portion (40), a flared proximal portion (44), and an intermediate portion (42), disposed between the distal portion and the proximal portion. The apparatus further includes a constricting flexible longitudinal element (38) passing circumferentially along the intermediate portion of the shunt, configured to constrict the intermediate portion of the shunt, and one or more proximal-portion-collapsing flexible longitudinal elements (36) configured to collapse the proximal portion of the shunt. Other embodiments are also described.