Endoscopic Helical Suture Anchor Deployment for Tissue Approximation
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Solution Overview
Problem
Existing endoscopic procedures for treating gastrointestinal bleeding and perforations lack a less complex solution that allows precise targeting of tissue without requiring modification of standard endoscopes, is maneuverable in tight spaces, and avoids unintended tissue damage.
Innovation Solution
A suture anchor deployment system with a helical portion that pierces and engages tissue, allowing sequential deployment through a conventional endoscope's working channel, and a deployment system that includes a detachable helical suture anchor and elongate suture for precise tissue reconfiguration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If thermal cautery is used to treat GI bleeding, then hemostasis can be achieved for small focal lesions, but there is a risk of causing perforation and re-bleeds occur commonly
Solution Approach 1:
The patent introduces a deployable tissue approximation device as an intermediary tool between the endoscope and the bleeding tissue. This device mechanically approximates tissue edges to achieve hemostasis without direct thermal contact, thereby eliminating perforation risk while maintaining effective bleeding control
Solution Approach 2:
The invention replaces the thermal mechanical system (cautery probe) with a mechanical tissue approximation system. Instead of using heat to cauterize tissue, the device uses mechanical forces to approximate and hold tissue edges together, achieving hemostasis through physical approximation rather than thermal destruction
2Reliability
If hemostasis clips are used to control bleeding, then compressive force can be applied to achieve hemostasis, but the clips are difficult to precisely position and cannot be removed or repositioned once fired
Solution Approach 1:
The patent employs a dynamic deployment mechanism where the tissue approximation device can be positioned, deployed, and potentially repositioned or removed. The system transitions from a static clip that cannot be moved to a dynamic device that maintains flexibility in positioning adjustments, allowing precise placement at the bleeding site while retaining the ability to correct positioning errors
3Reliability
If a complex suturing device is used to control GI bleeding, then the bleed can be sutured and cinched to provide hemostasis, but the system is complex and requires a specialized two channel therapeutic endoscope that is not widely available
Solution Approach 1:
The patent extracts the essential function of tissue approximation from complex suturing systems and implements it through a simplified deployable device. By removing unnecessary complexity and specializing requirements, the invention achieves hemostasis control through a single-channel endoscope-compatible device, making the system more accessible while maintaining therapeutic effectiveness
4Reliability
If multiple clips are used to control a bleed, then hemostasis can be achieved, but the surface area treated is limited and multiple separate interventions are required
Solution Approach 1:
The patent merges multiple separate clip interventions into a single integrated tissue approximation device. By combining the functions of multiple clips into one deployable system that can approximate tissue across a broader area, the invention increases the effective treatment surface area while reducing the number of separate interventions required to achieve hemostasis
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
Enables precise tissue approximation and reconfiguration without modifying the endoscope, maintaining maneuverability and reducing the risk of unintended tissue damage, while supporting various therapeutic treatments.
Implementation Method 1
The suture anchor has a distal helical portion and a proximal receptacle portion. The helical portion is adapted to engage tissue and be retained in the tissue.
Implementation Method 2
A suture eyelet is fixedly coupled to the suture anchor between the proximal and distal portions and is rotatable about the longitudinal axis of the suture anchor.
Data Source
AI summary
A deployment system includes a sheath, a torque able shaft having a handle positioned at its proximal end, a detachable helical first suture anchor positioned at the shafts distal end and an elongate suture fixedly coupled to the suture anchor. The deployment system can be positioned at a first tissue, and the shaft rotated to advance the helical first suture anchor into engagement with the first tissue. The shaft is detached from the first suture anchor thereby deploying it at the first tissue location. Then, the deployment system is removed from the patient, and a second suture anchor is coupled to the distal end of the shaft. The deployment system is re-inserted into the patient and the distal end of the system is moved adjacent a second tissue location, and the process is repeated for a second suture anchor at the second tissue location. A suture extends between the first and second fasteners, and tension is applied to the suture to draw the first and second tissues toward each other to reconfigure the tissue.