Surgical Staple Line Reinforcement Clip Design
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Solution Overview
Problem
Current surgical stapling instruments lack an effective mechanism to reinforce the staple line post-surgery, leading to potential bleeding and tissue separation issues.
Innovation Solution
A reinforcement clip comprising a crown, legs, and teeth, made of a deformable material, is used to anchor the staple line, which can be collapsed around staples by a surgical applier and retained in place, ensuring secure closure and hemostasis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical stapling instruments are used to seal severed tissue layers, then tissue sealing is achieved, but the staple line lacks reinforcement leading to potential bleeding and tissue separation
Solution Approach 1:
The reinforcement clip is nested within the staple cartridge, allowing it to be delivered through the same instrument channel. The clip is positioned to overlay the staple line after deployment, with its legs receiving the staples to secure them together, providing reinforcement without requiring a separate instrument.
Solution Approach 2:
The reinforcement clip acts as an intermediary element between the staples and the tissue layers. It receives and secures the staples through its legs, while its body overlays the staple line to provide additional reinforcement, preventing bleeding and tissue separation.
2Reliability
If a reinforcement clip is added to overlay and secure the staple line, then staple line reinforcement is achieved, but the device complexity increases
Solution Approach 1:
The reinforcement clip is divided into distinct functional segments: a body portion that overlays the staple line, legs that receive and secure the staples, and teeth that engage the tissue layers. This segmentation allows each component to perform its specific function efficiently while maintaining overall structural simplicity.
Solution Approach 2:
The reinforcement clip is constructed from a deformable material that allows it to be compressed by the applier jaws during delivery and then expand to its configured shape at the surgical site. This flexibility enables the clip to conform to the tissue and staple line while maintaining structural integrity for reinforcement.
3Ease of operation
If the reinforcement clip is made of deformable material to allow collapsing by applier jaws, then ease of delivery is improved, but the clip's structural strength may be compromised
Solution Approach 1:
The reinforcement clip transitions from a compressed, low-volume state during delivery to an expanded, structurally intact state at the surgical site. The deformable material allows the clip to be collapsed by the applier jaws for easy delivery through the instrument channel, then expands to its configured shape to provide reinforcement while maintaining structural 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
The reinforcement clip effectively secures the staple line, reducing bleeding and tissue separation, allowing for easy removal of the applier while maintaining clamping pressure, thereby enhancing surgical outcomes.
Implementation Method 1
the crown comprises a deformable material. The reinforcement clip is malleable such that the jaws of the applier may be closed around the reinforcement clip causing the reinforcement clip to collapse around staples
Data Source
Figure 1A~1B
Figure 2
Figure 3A
AI summary
An apparatus comprises a surgical instrument having a cutter and a stapler. The cutter is operable to sever a portion of tissue. The apparatus further comprises a plurality of staples where the stapler is operable to introduce the plurality of staples into tissue to form a staple line. The apparatus further comprises a reinforcement clip. The reinforcement clip is operable to be in selective communication with the staple line. The reinforcement clip comprises a crown, a leg portion, and a teeth portion. In some versions, the leg portion has a width operable to cover the area defined by the staple line. In some versions, the teeth portion is configured to anchor into tissue.