Blunt Tip Needle Hydrodissection for Pelvic Mesh Pocket Creation
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Solution Overview
Problem
Current surgical methods for mesh repair in female pelvic prolapse often result in mesh erosion due to incorrect tissue layer preparation, where the depth of tissue dissection is not accurately controlled, leading to potential damage to the bladder or vaginal walls.
Innovation Solution
A medical device with a needle member and insertion member that includes a blunt tip and a lumen for dissection fluid, allowing controlled depth insertion and hydrodissection between tissue layers, utilizing a pressure sensor to automatically inject fluid when a predetermined pressure level is reached, thereby creating a space for mesh placement without damaging deeper tissues.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If manual dissection is performed to create a pocket for mesh placement, then the operator can identify tissue layers and create space, but the depth control is imprecise leading to mesh erosion or bladder damage
Solution Approach 1:
The device performs preliminary hydrodissection by injecting fluid into the tissue plane before mesh implantation. This pre-creates the desired pocket space and separates tissue layers, ensuring accurate depth positioning is achieved before the mesh is placed, thereby preventing both erosion and bladder damage
Solution Approach 2:
A fluid intermediary is introduced between tissue layers to create separation and define the dissection plane. The fluid acts as a mediator that safely expands the tissue plane to the correct depth, providing tactile feedback to the operator and eliminating the need for imprecise manual dissection
2Volume of stationary object
If dissection is performed too close to the vagina sides, then the pocket is created, but mesh erosion occurs through the vagina after placement
Solution Approach 1:
The device incorporates pressure sensing feedback that monitors the resistance encountered during fluid injection. When the correct tissue plane is reached, a characteristic pressure change occurs, providing real-time feedback to the operator to stop injection at the precise depth, preventing erosion while ensuring adequate pocket volume
3Volume of stationary object
If dissection is performed at a deeper location, then more space is created, but damage or perforation to the bladder occurs
Solution Approach 1:
The hydrodissection is performed as a preliminary step that safely defines the dissection plane before mesh placement. The controlled fluid injection pre-creates the pocket at the correct depth, establishing safe boundaries that prevent subsequent bladder perforation while ensuring adequate space for mesh
Solution Approach 2:
Pressure feedback during fluid injection provides real-time information about tissue plane penetration. The operator can detect when the correct plane is reached and stop before risking bladder damage, while still achieving sufficient pocket volume for proper mesh placement
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 device enables precise control of tissue dissection depth, reducing the risk of mesh erosion and bladder damage by accurately creating a space between tissue layers, facilitating safer and more effective mesh implantation.
Implementation Method 1
a pressure sensor configured to sense a tissue pressure when the blunt tip is inserted into one or more tissue layers of a body
Implementation Method 2
a lumen configured to transfer dissection fluid, and an opening disposed proximate to the blunt tip that is configured to discharge the dissection fluid into a space between tissue layers
Data Source
AI summary
In one embodiment, a medical device may include an insertion member configured to be inserted into a body opening, and a needle member, movably coupled to the insertion member, configured to be inserted into the body opening. The needle member may include a lumen configured to transfer dissection fluid, a blunt tip located on a distal end of the needle member, and an opening disposed proximate to the blunt tip that is configured to discharge the dissection fluid into a space between tissue layers.