Adjustable Pelvic Implant for Urinary Incontinence

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Solution Overview

Problem

Current treatments for urinary and fecal incontinence, such as sling procedures, often result in complications like urethral obstruction, de novo urge incontinence, hemorrhage, prolonged urinary retention, infection, and tissue damage, and are not minimally invasive with significant side effects, limiting their effectiveness and quality of life improvement for patients.

Innovation Solution

The development of pelvic implants that engage and pull lateral urethral support tissue to tighten and provide slack reduction, eliminating the need for mesh or supportive structures under the urethra, using configurable shapes and anchoring mechanisms to stabilize the implants, and incorporating adjustable components for precise tensioning.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional sling procedures are used to treat incontinence, then urethral support is provided, but complications such as urethral obstruction, hemorrhage, infection, and tissue damage occur

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidcomplications and side effects
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent removes the mesh component traditionally used in sling procedures and replaces it with an adjustable suture system. This extraction of the mesh element eliminates the source of many complications while preserving the supportive function through alternative means (adjustable sutures tied to anchors), directly addressing the contradiction between treatment effectiveness and complication reduction

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention introduces an adjustable suture system that can be modified post-implantation to change tension and positioning. This dynamic capability allows optimization of urethral support while minimizing harmful effects, as the system can be adjusted to achieve the right balance between support and avoiding obstruction or tissue damage

Inventive Principle:
Principle #15Dynamics

2Strength

If mesh or supportive structures are placed under the urethra, then urethral support is enhanced, but tissue damage and infection risks increase

Engineering Contradiction:
Improveurethral supportVSAvoidtissue damage and infection
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent explicitly removes mesh from the implant system, replacing it with sutures and anchors. This extraction eliminates the foreign body reaction and infection risks associated with mesh while maintaining urethral support through the suture-tension mechanism, directly resolving the contradiction between support strength and tissue safety

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The use of absorbable sutures replaces permanent mesh structures. These sutures provide temporary support during the critical healing period and then naturally degrade, eliminating long-term foreign body presence that causes tissue damage and infection risks while still providing necessary support strength during recovery

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Ease of operation

If fixed tension sling procedures are performed, then surgical simplicity is maintained, but precision in tensioning is limited

Engineering Contradiction:
Improvesurgical simplicityVSAvoidtensioning precision
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The adjustable suture system allows post-surgical modification of tension, transforming a static fixed-tension approach into a dynamic system. This enables precise tensioning to be achieved after implantation, combining surgical simplicity with precision through a two-stage process (simple implantation followed by precise adjustment)

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The surgical procedure is simplified by implanting the basic structure (anchors and sutures) without requiring precise tensioning at the time of surgery. The precision action is performed later during adjustment, separating the complex precision requirement from the initial surgical procedure, thereby maintaining surgical simplicity while achieving tensioning precision

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS20220287816A1Minimally invasive implant and method
Publication Date: 2022.09.15 BOSTON SCIENTIFIC SCIMED INC
  • US20220287816A1 patent drawing
  • US20220287816A1 patent drawing
  • US20220287816A1 patent drawing

AI summary

Apparatus and methods are provided for treating urinary incontinence, fecal incontinence, and other pelvic defects or dysfunctions, in both males and females, using one or more lateral implants to reinforce the supportive tissue of the urethra. The implants can be configured as a sling device having at least one extension arm and a tissue support portion having an eyelet, wherein a portion of the at least one extension arm is adapted to slide through and adjustably attach with the eyelet.