Suture Anchor Deployment for GI Bleeding and Perforation Closure

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Solution Overview

Problem

Current endoscopic procedures for treating gastrointestinal bleeding and perforations lack precision and flexibility, with existing instruments being cumbersome, difficult to maneuver, and often requiring modification of standard endoscopes, which limits their practicality and increases the risk of unintended tissue damage.

Innovation Solution

A suture anchor deployment system that includes a helical portion for engaging tissue, a proximal receptacle, and a rotatable suture eyelet, allowing for precise placement and repositioning of suture anchors within the body, along with a deployment system that can be used through a conventional endoscope without modifying it, enabling flexible and accurate tissue reconfiguration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If hemostasis clips are used to control GI bleeding, then hemostasis can be achieved through compressive force, but the clips are difficult to precisely position and cannot be removed or repositioned once fired

Engineering Contradiction:
Improvehemostasis controlVSAvoidpositioning precision and repositionability
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The suture anchor system allows dynamic adjustment of tissue approximation. The sutures can be tensioned to draw tissue anchors into apposition and then cinched to maintain tension, providing both initial positioning capability and ongoing adjustability, unlike static clips that cannot be repositioned

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system enables recovery and repositioning of the tissue approximation function. If initial clip placement is incorrect, multiple clips must be used; with the suture system, the sutures can be released, repositioned, and re-tensioned to achieve proper tissue apposition

Inventive Principle:
Principle #34Discarding and recovering

2Reliability

If thermal cautery is used to treat small bleeds, then hemostasis can be obtained through cauterization, but there is a risk of causing perforation with the cautery probe

Engineering Contradiction:
Improvehemostasis achievementVSAvoidperforation risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system replaces thermal mechanical cautery with a mechanical suture-based tissue approximation system. Instead of using heat and a probe that risks perforation, the system uses sutures to draw tissue anchors into apposition, achieving hemostasis through compression and sealing without thermal damage or perforation risk

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The suture anchors act as intermediaries between the tissue edges and the tensioning mechanism. Rather than directly applying heat or mechanical force to the bleed site with a probe, the system uses anchors embedded in tissue and connected by sutures to indirectly achieve tissue approximation and hemostasis

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If a suturing device is used to control GI bleeding and stitch perforations, then hemostasis and perforation closure can be achieved, but the system is complex and requires a specialized two channel therapeutic endoscope that is not widely available

Engineering Contradiction:
Improvebleed control and perforation closureVSAvoidsystem complexity and endoscope requirements
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The suture anchors and delivery system can be used for multiple functions including controlling GI bleeding, closing perforations, and creating tissue approximations for various procedures. The system works with standard endoscopes rather than requiring specialized two-channel therapeutic endoscopes, increasing accessibility and versatility

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The system divides the complex suturing function into separate components: the delivery system that places anchors, the anchors themselves that engage tissue, and the sutures that provide tension. This modular approach simplifies the overall system compared to integrated specialized suturing endoscopes

Inventive Principle:
Principle #1Segmentation

4Reliability

If multiple clips are used to control a bleed or close a perforation, then hemostasis can be achieved, but each clip is small and has surface area to act only on a localized area of tissue

Engineering Contradiction:
Improvehemostasis controlVSAvoidtissue coverage area
Core Design Contradiction:
ReliabilityVSArea of stationary object

Solution Approach 1:

The system merges multiple tissue approximation functions into a continuous suture that connects multiple anchors. Instead of separate clips acting on localized areas, the suture distributes tension across multiple anchors, creating a broader tissue approximation effect and larger effective coverage area

Inventive Principle:
Principle #5Merging (Combining)

Data Source

PatentUS12167844B2Endoscopic tissue approximation system and methods
Publication Date: 2024.12.17 BOSTON SCIENTIFIC SCIMED INC
  • US12167844B2 patent drawing
  • US12167844B2 patent drawing
  • US12167844B2 patent drawing

AI summary

A cinch deployment system includes a delivery system and a releasable cinch including an inner tubular, a compressible gripper having a suture passage, the gripper positioned within the inner tubular housing, and a resilient structure biased to compress the gripper to reduce the size of the suture passage. The resilient structure has a first configuration in which the resilient structure is constrained from applying sufficient compression to the gripper to prevent movement of the gripper on the suture, and a second configuration in which sufficient compression is applied to secure the gripper on the suture. The resilient structure is moved from the first to the second configuration by movement of the retainer moved by the deployment system.