Segmented Seal Sterilization Pouch for Aseptic Opening
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Solution Overview
Problem
Conventional sterilization pouches are difficult to open aseptically, especially when containing larger objects, as they often shear instead of peeling apart, risking contamination and requiring multiple individuals to manage the pouch safely.
Innovation Solution
A sterilizable pouch design featuring a central pre-formed opening means with breathable and non-fibrous materials, allowing the pouch to be opened from the center without compromising aseptic presentation, with releasable seams that can be grasped and pulled apart to minimize contact with non-sterile surfaces.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the pouch is opened from the end using conventional self-seal or heat seal methods, then the seal can be broken, but the pouch material tends to shear instead of peal apart, causing non-sterile surfaces to contact the enclosed object and risking contamination
Solution Approach 1:
The pouch seal is segmented into multiple separate seals distributed along the pouch rather than a single continuous seal. This allows the pouch to be opened by breaking individual seals in sequence from the end, enabling controlled opening that maintains aseptic integrity while improving ease of operation.
Solution Approach 2:
The pouch includes pre-formed tear notches or initiation points at the sealed end that prepare the seal for controlled breaking. These preliminary features guide the opening process to start at the correct location and proceed in a controlled manner, preventing uncontrolled shearing and maintaining sterility.
2Ease of operation
If the user extends arms to peal open a long self-seal pouch from the end, then the seal can be opened, but the user may lose control of the pouch material and nonsterile parts may touch the tray
Solution Approach 1:
By dividing the seal into multiple segments, the opening process is broken into smaller, more manageable steps. The user opens one seal at a time rather than attempting to peal the entire length simultaneously, maintaining better control and reducing contamination risk.
Solution Approach 2:
Instead of opening the pouch from the end by pealing the entire seal at once, the invention inverts the approach by using multiple discrete seals that are broken sequentially. This reverses the conventional single-action opening method into a multi-step process that improves control.
3Reliability
If a rolled seal is used to prevent unrolling, then the pouch can be secured, but two individuals are required to move the tray aseptically (one to open the rolled end and hold it, another to reach inside and remove the tray)
Solution Approach 1:
The sealed end is divided into multiple separate seals rather than a single rolled seal. This segmentation allows one person to systematically break each seal in sequence while maintaining control of the pouch, eliminating the need for a second person to assist with holding or managing the sealed end.
Solution Approach 2:
The pouch design enables a single user to independently open the sealed end by breaking multiple seals in sequence without requiring assistance from another person. The structure is self-sufficient for single-person operation while maintaining aseptic integrity.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables easy, aseptic opening and removal of items from the pouch, reducing the risk of contamination and allowing single-person operation by shortening the arm extension required, thus maintaining control and preventing non-sterile surfaces from contacting the enclosed object.
Implementation Method 1
A portion of the pouch may be formed from a breathable (e.g., fibrous) material, such as paper or Tyvek® plastic sheet, which enables sterilization medium to pass there through
Implementation Method 2
A second method involves the use of a heat seal (also referred to as a hot seal). In a heat seal, the two pouch layers near the open end may be sealed by applying concentrated heat to the area to cause the two surfaces to fuse together and create a seal
Data Source
AI summary
A sterilizable pouch includes at least one sheet, wherein outer peripheral edges of the at least one sheet are sealed together to define a pouch having an interior space for receiving an article therein. A first releasable seam spans between a first peripheral edge of the at least one sheet to a second, opposite, peripheral edge of the at least one sheet, the first releasable seam dividing the at least one sheet into a first sheet part and a second sheet part. A second releasable seam and a third releasable seam each substantially span from a third peripheral edge of the at least one sheet to a fourth, opposite, peripheral edge of the at least one sheet and along the first peripheral edge and the second peripheral edge, respectively. The second and third releasable seams are arranged generally perpendicular to the first releasable seam, where the first, second and third releasable seams enable the pouch to be completely opened such that a device can be removed from the pouch without the device contacting non-sterile portions of the pouch.