Reusable Sling Delivery Device Segmentation for Sterilization

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Solution Overview

Problem

Conventional sling delivery devices are typically single-use and difficult to clean and sterilize, posing health and safety hazards due to their non-disassembleable design, which limits their reuse in surgical procedures.

Innovation Solution

A medical device comprising a needle member, a handle, and a pusher member with a bendable sheath and extension member that can be decoupled and reassembled, allowing for easy sterilization and reuse, featuring a protrusion component to limit movement during procedures and adjustable pin assemblies for secure coupling and decoupling.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional sling delivery devices are designed for single-use with non-disassembleable construction, then device reliability and safety are improved, but device complexity and cost increase, and productivity decreases due to discarding after one use

Engineering Contradiction:
Improvedevice safetyVSAvoiddevice reuse capability
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The delivery device is divided into separable components including a handle assembly, a needle assembly, and a sling assembly that can be independently sterilized and reused. The handle assembly contains a track mechanism that receives the needle assembly, allowing disassembly for sterilization and reassembly for subsequent procedures.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Instead of discarding the entire delivery device after single use, the invention enables recovery and reuse of the handle assembly and needle assembly through sterilization processes. Only the sterile sling implant is discarded after use, while the delivery mechanism is recovered, cleaned, sterilized, and prepared for future procedures.

Inventive Principle:
Principle #34Discarding and recovering

2Ease of operation

If conventional sling delivery devices are constructed as integrated non-disassembleable units, then ease of operation during procedure is improved, but ease of repair and sterilization worsens

Engineering Contradiction:
Improveprocedure simplicityVSAvoidsterilization accessibility
Core Design Contradiction:
Ease of operationVSEase of repair

Solution Approach 1:

The device is segmented into modular assemblies (handle, needle, sling) that can be separated. The handle assembly includes a track with protrusions and recesses that guide the needle assembly, allowing the needle to be removed and the handle to be sterilized independently in autoclave or other sterilization systems.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The needle assembly is extracted as a separate removable component from the handle assembly. The needle can be pushed through the track mechanism and removed after use, allowing the handle to be fully accessed for sterilization while the needle can be separately processed or replaced.

Inventive Principle:
Principle #2Taking out (Extraction)

3Object-affected harmful factors

If single-use delivery devices are discarded after one procedure, then health and safety hazards are reduced, but loss of substance and increased cost occur

Engineering Contradiction:
Improvecontamination riskVSAvoiddevice material waste
Core Design Contradiction:
Object-affected harmful factorsVSLoss of substance

Solution Approach 1:

The handle assembly and needle assembly are recovered after each procedure through systematic disassembly and sterilization. The sling implant itself is discarded as it is single-use sterile material, but the delivery mechanism is reused multiple times after proper sterilization, reducing material waste and cost.

Inventive Principle:
Principle #34Discarding and recovering

Solution Approach 2:

The device transitions from a single-use state to a reusable state by changing the sterilization parameter. After each procedure, the device undergoes sterilization treatment (autoclave, chemical sterilization, or other validated methods) that transforms it from a contaminated state to a sterile state suitable for reuse.

Inventive Principle:
Principle #35Parameter changes

4Device complexity

If conventional delivery devices lack disassembly capability, then device complexity is reduced, but ease of operation for sterilization and reuse worsens

Engineering Contradiction:
Improvestructural simplicityVSAvoiddisassembly and assembly ease
Core Design Contradiction:
Device complexityVSEase of operation

Solution Approach 1:

The device uses clear segmentation with defined interfaces: the needle assembly has a proximal end that interfaces with the track in the handle assembly. The track contains protrusions that engage with recesses on the needle, creating a simple but effective coupling mechanism that is easy to assemble and disassemble.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The needle assembly is nested within the handle assembly during use, with the needle sliding through the track mechanism. This nested configuration allows the smaller needle component to be easily inserted into and removed from the larger handle assembly, simplifying the disassembly and reassembly process.

Inventive Principle:
Principle #7Nested doll (Nesting)

Data Source

PatentUS10219829B2Reusable delivery devices
Publication Date: 2019.03.05 BOSTON SCIENTIFIC SCIMED INC
  • US10219829B2 patent drawing
  • US10219829B2 patent drawing
  • US10219829B2 patent drawing

AI summary

According to an aspect, a medical device includes a needle member having a curved portion, a handle coupled to the needle member, and a pusher member including a sheath and an extension member. The sheath may be bendable. The extension member is configured to be slidably coupled to a track of the handle such that extension member slides within the track during a medical procedure. The sheath defines a lumen configured to receive a portion of the needle member. The extension member is configured to be de-coupled from the track of the handle after the medical procedure. The sheath is configured to be de-coupled from the needle member after the medical procedure. In some examples, the sheath of the pusher member is configured to bend to conform to the curved portion when the sheath of the pusher member is moved over the curved portion of the needle member.