Flexible Barrier Member for Surgical Sterility

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Solution Overview

Problem

Current surgical sterilization techniques and devices fail to effectively prevent the introduction of undesirable contaminants, such as pathogenic bacteria and viral particles, during procedures through body openings, leading to potential complications.

Innovation Solution

A medical device with a flexible member that can be inserted into a body opening, featuring a distal end with a closed end and a proximal end with an open end, along with an elongate portion, to cover the opening and surrounding area, utilizing a fixation mechanism, adhesive coating, and antimicrobial agents to maintain sterility.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If disinfectants and sterile gloves are used during surgical procedures, then the sterilization of the surgical field is improved, but the surgical devices and materials may still contain undesirable contaminants

Engineering Contradiction:
Improvesterilization effectivenessVSAvoidcontaminant presence on surgical devices
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

A flexible barrier member is introduced as an intermediary between the external environment and the surgical field. This barrier member covers the body opening and extends along the surgical device, creating a sterile interface that prevents contaminant transfer while allowing the surgical procedure to proceed. The barrier member acts as a mediator that isolates the surgical field from potential contaminants without interfering with the surgical operations.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention employs a flexible barrier member in the form of a thin film or shell that can be conformally placed over the body opening and along the surgical device. This flexible structure adapts to the contours of the body opening and device surface, providing continuous coverage and sterilization protection. The flexible nature allows it to maintain contact and sealing without rigid structural constraints.

Inventive Principle:
Principle #30Flexible shells and thin films

2Reliability

If the surgical field is thoroughly sterilized to prevent contamination, then the safety is improved, but the complexity of the surgical procedure increases

Engineering Contradiction:
Improvesurgical safetyVSAvoidsterilization procedure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The barrier member is prepared and positioned before the surgical procedure begins, establishing the sterile field in advance. By pre-placing the barrier over the body opening and along the device, the sterilization function is accomplished prior to the main surgical operations, simplifying the overall procedure flow. The preliminary placement ensures sterility is already established when surgical activities commence.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The flexible barrier member serves multiple functions simultaneously: it acts as a physical barrier against contaminants, maintains the sterile field, and allows passage of surgical instruments. This multi-functional design consolidates several sterilization and protective functions into a single component, reducing the number of separate steps and materials needed for comprehensive surgical sterilization.

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

Data Source

PatentUS10441397B2Medical device and method for conducting a surgery through a body opening
Publication Date: 2019.10.15 BOSTON SCIENTIFIC SCIMED INC
  • US10441397B2 patent drawing
  • US10441397B2 patent drawing
  • US10441397B2 patent drawing

AI summary

A medical device and method for facilitating a surgery through a body opening is disclosed. The medical device includes a flexible member configured to be placed within the body opening so as to cover a portion of the body opening. The flexible member includes a distal end portion with a closed end, a proximal end portion with an open end and an elongate portion joining the proximal end portion and the distal end portion. The proximal end portion is configured to extend out of the patient's body opening to cover an area around and outside the patient's body opening.