Heart Pump Cuff Composite Base for Bleeding Control
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Solution Overview
Problem
Current heart pump implantation techniques face challenges with bleeding and blood leaks due to the heart's continuous pumping and movement, which can lead to a temporary and weakened fluid tight connection after implantation, increasing the risk of adverse events.
Innovation Solution
A method involving coring an opening in the heart and attaching a flexible layer-coupled conduit with a base, which includes a port for the heart pump, to establish a secure and fluid-tight connection, using materials like felt or polyester to promote tissue ingrowth and reduce bleeding and leaks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a conventional LVAD implantation technique is used with a simple conduit secured in the heart wall, then the implantation procedure is simple and quick, but tissue bleeding and blood leaks occur after implantation due to heart movement
Solution Approach 1:
The base is constructed as a composite structure combining a rigid or semi-rigid structural layer with a flexible material layer. The rigid portion provides structural support and anchoring strength, while the flexible material (such as felt, polyester, or other porous materials) conforms to the heart wall surface and promotes tissue ingrowth. This composite construction allows the base to maintain a secure, fluid-tight connection despite heart movement, resolving the contradiction between easy implantation and connection stability.
Solution Approach 2:
The base incorporates a flexible material layer that can deform and conform to the dynamic surface of the heart wall. This flexibility allows the base to accommodate heart movement and pulsation while maintaining continuous contact and sealing against the tissue, preventing blood leaks without requiring overly complex rigid fixation structures.
2Reliability
If a rigid base is used to ensure stable connection, then fluid tight connection is maintained, but tissue damage and difficulty in tissue ingrowth occur
Solution Approach 1:
The base combines rigid and flexible materials in a single structure. The rigid structural layer provides the necessary mechanical strength and stability for secure anchoring, while the flexible material layer (such as felt or polyester) reduces stress concentration on the tissue and promotes healthy tissue ingrowth by being more compliant and biocompatible.
Solution Approach 2:
Different regions of the base have different properties: the structural layer provides rigidity where mechanical strength is needed for anchoring, while the flexible material layer contacts the tissue directly to minimize damage and promote healing. This spatial differentiation of material properties allows the base to simultaneously achieve connection stability and tissue compatibility.
3Object-generated harmful factors
If the heart is stopped during implantation to establish fluid tight connection, then bleeding is controlled during surgery, but the patient faces risks associated with cardiopulmonary bypass
Solution Approach 1:
The base is designed with pre-formed sealing surfaces and conforming flexible material layers that create immediate sealing upon attachment to the heart wall. The coring tool is also pre-configured to create a precise opening that receives the base, ensuring proper alignment and sealing before the heart resumes beating. This preliminary preparation allows for minimal heart stopping time or potentially off-pump implantation.
Solution Approach 2:
The design replaces the need for complex mechanical clamping or suturing systems with a more straightforward insertion and sealing mechanism. The base's flexible material layer naturally conforms to the heart wall opening and creates a seal through material compliance rather than aggressive mechanical compression, reducing the need for prolonged cardiopulmonary bypass.
4Object-affected harmful factors
If a flexible base material is used to reduce tissue damage, then tissue compatibility improves, but the base may not provide sufficient structural support for stable connection
Solution Approach 1:
The base is constructed as a composite structure where a rigid or semi-rigid structural layer provides the necessary mechanical strength and structural support for stable anchoring, while a flexible material layer (such as felt, polyester, or other porous materials) is integrated to provide tissue compatibility, conformability, and promotion of tissue ingrowth. This composite construction allows both requirements to be satisfied simultaneously.
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 solution effectively limits tissue bleeding and blood leaks during and after heart pump implantation by creating a stable, flexible interface that promotes tissue attachment and sealing, enhancing the durability of the connection and reducing post-implantation complications.
Implementation Method 1
using materials like felt or polyester to promote tissue ingrowth and reduce bleeding and leaks
Implementation Method 2
The flexible layer may be configured to engage the outer surface of the heart... establish a secure and fluid-tight connection
Data Source
AI summary
At least some embodiments of the disclosure may advantageously limit bleeding and the occurrence of blood leaks after heart pump implantation. In some embodiments, a base may be provided that includes a flexible layer mechanically coupled with a conduit. The flexible layer may be coupled with the proximal end of the conduit. The conduit may be configured to receive a cannula of the heart pump therethrough. The outer surface of the conduit may be configured to engage a surface of the heart formed after coring the heart. The conduit may be metal and may have a flared and/or beveled distal end. The conduit may be a flexible material. A distal flexible layer may be provided at a distal end of the conduit that is configured to engage with an inner surface of the heart.