Growth-accommodating heart valve system

Brief Description

This technology describes a prosthetic heart valve system designed to accommodate the growth of children.

Suggested uses

·Pediatric Cardiac Surgery: Primary application in pediatric cardiac surgery for replacing diseased or malfunctioning heart valves in children with congenital heart disease.

·Congenital Heart Defect Treatment: Specifically designed to address congenital heart defects in pediatric patients, providing a tailored solution for their unique needs.

·Long-Term Valve Replacement: Offers a solution for long-term valve replacement in pediatric patients, potentially reducing the need for multiple surgeries as the child grows.

·Growth-Responsive Valve: Designed to accommodate the natural growth of children, ensuring continued functionality and efficacy as the child's heart grows.

·Preventing Valve Dysfunction: Helps prevent valve dysfunction by adapting to the changing dimensions of the child's heart over time.

·Customized Treatment: Provides a customizable treatment option based on the unique needs and growth trajectory of each pediatric patient.

·Advancing Pediatric Cardiology: Represents an advancement in pediatric cardiology by addressing the challenges associated with valve replacement in growing children, potentially leading to improved outcomes and long-term prognosis.

·Minimally Invasive Procedures: Suitable for transcatheter implantation, allowing for minimally invasive procedures compared to traditional open-heart surgery.

·Enhancing Quality of Life: Aims to improve the quality of life for pediatric patients with congenital heart disease by providing a durable and effective valve replacement option.

·Reducing Complications: Designed to mitigate complications such as paravalvular leak, enhancing the safety and effectiveness of the valve replacement procedure.

Features/Benefits

Features:

• Designed to expand radially to accommodate the child's growth.
• Constructed with support beams interconnected by joints, forming a web-like cylindrical cage.

• Multiple leaflets forming the valve.
• Attached to the expandable stent along a path that maintains length during expansion.

3. Transcatheter Implantation:

• Can be implanted transcatheterly, minimizing the invasiveness of the procedure. 

4. Size Range:

• Lower limit diameter of 9 mm and upper limit diameter of 25 mm, suitable for pediatric patients.

5. Leaflet Material Options: 

• Leaflets can be made from biological tissue or stretchable polymeric material, providing flexibility in material selection.

6. Skirt for Paravalvular Leak Mitigation: 

• Includes a skirt around the outer surface to mitigate paravalvular leak, made from a stretchable polymer. 

7. Technical Design for Functionality:

• Utilizes excessive leaflet tissue in the contracted configuration to facilitate expansion without requiring increased blood pressure to open the valve.
• Attachment path for leaflets remains relatively unchanged during expansion, preventing tearing.
• Leaflets maintain valve closure at different three-dimensional configurations as the stent expands. 

Benefits:

1. Growth Accommodation:

• Addresses the challenge of accommodating the growth of pediatric patients, reducing the need for multiple valve replacements.

2. Minimized Invasiveness:

• Transcatheter implantation reduces the invasiveness of the procedure compared to traditional open-heart surgery.

3. Versatility:

• Provides options for leaflet material, allowing customization based on patient needs and preferences.

4. Reduced Risk of Complications:

• Skirt design helps mitigate paravalvular leak, reducing the risk of complications post-implantation.

5. Long-Term Functionality:

• Designed to maintain valve functionality as the child grows, potentially enhancing long-term outcomes and quality of life.

6. Innovative Design:

• Incorporates unique technical features to ensure functionality and durability during growth and expansion.

Technology Description

This invention addresses a significant need in pediatric cardiology by providing a prosthetic valve system that can grow with the child, potentially reducing the need for multiple valve replacements as the child matures.

1. Summary of the Invention:

• The prosthetic valve system includes an expandable stent and multiple leaflets forming a valve.
• The stent expands radially while maintaining the length of the path to which the leaflets are attached, ensuring the valve's functionality as the child grows.
• The system can be implanted transcatheterly.
• The expandable stent is constructed with support beams interconnected by joints, forming a web-like cylindrical cage.

2. Embodiments:

• The expandable stent may have a lower limit diameter of 9 mm and an upper limit diameter of 25 mm.
• Leaflets can be made from biological tissue or stretchable polymeric material.
• A skirt around the outer surface of the system may be included to mitigate paravalvular leak, made from a stretchable polymer.

3. Technical Features:

• The invention utilizes excessive leaflet tissue in the contracted configuration to allow for expansion without requiring more blood pressure to open the valve.
• The attachment path for leaflets does not change significantly during expansion, preventing tearing.
• Leaflets maintain valve closure even as the stent expands, adapting to different three-dimensional configurations.

State Of Development

Prototype developed

Patent Status