Pelvic Implant with Composite Synthetic-Biologic Materials

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Solution Overview

Problem

Existing medical implants for pelvic organ prolapse treatment lack a combination of polypropylene and biological materials tailored for specific anatomical locations, limiting their effectiveness in providing both long-term support and minimizing erosion.

Innovation Solution

A medical device comprising a first elongate member made of synthetic material and a second elongate member made of biologic material, configured to form a defined non-planar shape for attachment to distinct bodily portions, such as the anterior and posterior vaginal walls, with the option of a third elongate member for sacral attachment, allowing for customizable support and reduced erosion.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If synthetic polypropylene graft material is used, then long-term reinforcement and support are provided, but erosion risk increases compared to biologic grafts

Engineering Contradiction:
Improvelong-term reinforcementVSAvoiderosion risk
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The medical device applies different material properties to different anatomical locations: synthetic polypropylene material is used in regions requiring strong reinforcement (anterior and posterior vaginal walls), while biologic material is used in regions where erosion risk is a concern (vaginal cuff area). This local differentiation resolves the contradiction by providing strength where needed while minimizing erosion risk in sensitive areas.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The device combines synthetic polypropylene material and biologic material into a single composite graft structure. The synthetic portions provide long-term mechanical support and reinforcement, while the biologic portions reduce erosion risk and promote tissue integration. This composite approach simultaneously achieves both long-term strength and reduced harmful effects.

Inventive Principle:
Principle #40Composite materials

2Device complexity

If a single-material graft is used, then the device structure is simpler, but it cannot be tailored to specific anatomical locations with different material requirements

Engineering Contradiction:
Improvedevice structureVSAvoidanatomical location tailoring
Core Design Contradiction:
Device complexityVSAdaptability or versatility

Solution Approach 1:

The graft is designed with spatially varying material properties: synthetic material in anterior/posterior portions for structural support, and biologic material in the central vaginal cuff portion for erosion prevention. This local quality differentiation enables anatomical tailoring while maintaining a relatively simple overall device structure that can be manufactured as a single integrated component.

Inventive Principle:
Principle #3Local quality

Data Source

PatentUS10213286B2Implantable medical device and methods of delivering the implantable medical device
Publication Date: 2019.02.26 BOSTON SCIENTIFIC SCIMED INC
  • US10213286B2 patent drawing
  • US10213286B2 patent drawing
  • US10213286B2 patent drawing

AI summary

A medical device and method of delivery of the medical device within a patient's body are disclosed by the present invention. The medical device includes a first elongate member and a second elongate member. The first elongate member further includes a proximal end portion and a distal end portion. The first elongate member is made of a first material. The second elongate member includes a first portion and a second portion. The first portion of the second elongate member is attached to the first elongate member and the second portion of the second elongate member is attached to the first portion of the second elongate member at one of its transverse edge. The first portion and the second portion of the second elongate member are configured to form a defined non-planar shape such that the first portion is a first arm of the defined non-planar shape and the second portion is a second arm of the defined non-planar shape. The second elongate member is made of a second material different than the first material of the first elongate member.