Expandable Tissue Anchor Minimizes Contact Pressure
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Solution Overview
Problem
Conventional surgical methods for treating morbid obesity, such as gastrointestinal reduction systems, face challenges in securely anchoring tissue without causing necrosis or over-compression, particularly when engaging the muscularis or serosa layers, and require extensive training and time, with existing devices being unsuitable for low-profile delivery and lacking precise force application.
Innovation Solution
A reconfigurable 'basket'-type tissue anchor with configurable struts or legs, made from shape memory or superelastic alloys, that self-forms into an expanded configuration to minimize contact with the tissue, allowing for constant force application and accommodating tissue movements while preventing over-compression, and includes features like frictional regions and spring members to ensure optimal loading and blood flow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If conventional sutures or staples are used to secure tissue, then tissue can be anchored, but significant force is concentrated over a small surface area causing tissue tearing or necrosis
Solution Approach 1:
The anchor is divided into multiple struts (typically 3-6) that distribute the securing force across multiple contact points on the tissue surface, rather than concentrating force at a single point like conventional sutures or staples
Solution Approach 2:
The anchor transitions from a flat, two-dimensional configuration during delivery to a three-dimensional radially expanded configuration at the deployment site, increasing the surface area in contact with tissue and distributing force across multiple dimensions
2Strength
If rigid anchors are used to engage the muscularis and serosa layers, then proper foundation is provided for tensile loads, but the anchor may puncture adjacent tissue or organs during transesophageal placement
Solution Approach 1:
The anchor employs a transformable structure that transitions from a low-profile compressed state during delivery to a radially expanded state at the deployment site, allowing safe passage through the esophagus followed by secure engagement with the stomach wall
Solution Approach 2:
The anchor struts are nested within or against each other in a compressed configuration during delivery through the esophagus, similar to nested dolls, allowing the device to pass through narrow passages before expanding at the target site
3Reliability
If conventional sewing instruments are used to create plications, then tissue can be secured, but extensive time and multiple intubations are required
Solution Approach 1:
The anchor integrates multiple functions into a single device: it provides tissue grasping, plication formation, and securement in one component, eliminating the need for separate suturing steps and multiple intubations
Solution Approach 2:
The anchor serves multiple purposes simultaneously: it acts as a grasping tool, a plication device, and a securing mechanism, replacing the need for separate conventional sewing instruments and procedures
4Stability of the object's composition
If conventional anchors are used to secure tissue plications, then tissue can be held in place, but the anchors cannot accommodate tissue movements without over-compression or relaxation
Solution Approach 1:
The anchor incorporates flexible struts that can dynamically adjust their configuration in response to tissue movements, maintaining stable plication while accommodating physiological changes in the gastrointestinal tract
Solution Approach 2:
The anchor allows for adjustment of the compression force applied to the tissue, enabling the device to maintain optimal plication stability while adapting to varying tissue movements and physiological conditions
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 tissue anchor maintains secure tissue plications with minimal tissue damage, allows for adequate blood flow, and ensures consistent force application over a range of tissue deflections, reducing the risk of necrosis and improving procedural efficiency.
Implementation Method 1
A reconfigurable 'basket'-type tissue anchor with configurable struts or legs, made from shape memory or superelastic alloys, that self-forms into an expanded configuration
Implementation Method 2
A reconfigurable 'basket'-type tissue anchor with configurable struts or legs, made from shape memory or superelastic alloys, that self-forms into an expanded configuration
Implementation Method 3
The contacted tissue is then typically drawn into the sewing instrument where one or more sutures or tags are implanted to hold the suctioned tissue in a folded condition
Implementation Method 4
includes features like frictional regions and spring members to ensure optimal loading and blood flow
Implementation Method 5
includes features like frictional regions and spring members to ensure optimal loading and blood flow
Data Source
Figure 1A~1B
Figure 2A~2B
Figure 3A~5B
AI summary
Apparatus & methods for optimizing anchoring force are described herein. In securing tissue folds, over-compression of the tissue directly underlying the anchors is avoided by utilizing tissue anchors having expandable arms configured to minimize contact area between the anchor and tissue. When the anchor is in its expanded configuration, a load is applied to the anchor until it is optimally configured to accommodate a range of deflections while the anchor itself exerts a substantially constant force against the tissue. Various devices, e.g., stops, spring members, fuses, strain gauges, etc., can be used to indicate when the anchor has been deflected to a predetermined level within the optimal range. Moreover, other factors to affect the anchor characteristics include, e.g., varying the number of arms or struts of the anchor, positioning of the arms, configuration of the arms, the length of the collars, etc.