Dynamic Inter-Spinous Spacer With Percutaneous Fluid Adjustment
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Solution Overview
Problem
Existing inter-spinous process spacers for treating spinal disorders are invasive, prone to mechanical failure, and may cause allergic reactions, with limited adjustability and compatibility with individual anatomy.
Innovation Solution
A dynamic, variable height inter-spinous process spacer with an expandable member, self-sealing percutaneous access port, and anchor member that can be securely implanted between vertebrae, allowing for adjustable sizing and positioning through fluid inflation or deflation, and featuring removable flanges for customizable fit and reduced risk of fracture.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If traditional lumbar decompression with laminectomy or spinal fusion is performed, then pressure on spinal cord and nerve roots is relieved, but surgical invasiveness increases and rehabilitation time extends
Solution Approach 1:
The spacer is divided into multiple components including an upper body, lower body, expandable member, and operative panels that can be inserted separately through a minimally invasive approach. The expandable member is inserted first, followed by the bodies and panels, allowing staged deployment without extensive surgical exposure
Solution Approach 2:
The operative panels are positioned between the lateral members of the bodies and are nested within the overall spacer structure. The expandable member is housed within the bodies, and the entire assembly is inserted through a small incision, with components nested together for compact delivery
2Adaptability or versatility
If a fixed-height inter-spinous process spacer is used, then implantation is simpler, but adaptability to individual anatomy is limited
Solution Approach 1:
The spacer incorporates an expandable member that can be inflated or deflated to dynamically adjust the height of the operative panels. This allows the device to transition from a compact inserted state to an expanded functional state, adapting to the specific anatomical requirements of each patient
Solution Approach 2:
The height of the operative panels is changed by altering the volume of the expandable member through fluid injection or withdrawal. This parameter change allows continuous adjustment of the spacer height to match individual patient anatomy without requiring multiple fixed-size implants
3Strength
If the expandable member is made larger to increase contact area with spinous processes, then loading force distribution improves, but the risk of dislodgement increases
Solution Approach 1:
The expandable member is pre-inflated to a controlled size before insertion, and the operative panels are positioned between the lateral members to engage the spinous processes. This preliminary configuration ensures proper engagement and distribution of loading forces before the device is fully deployed
Solution Approach 2:
The expandable member is constructed as a flexible, compliant structure that can deform to conform to the shape of the spinous processes. This flexibility allows the member to adapt to anatomical variations while maintaining secure engagement and distributing loads evenly across the contact surfaces
4Adaptability or versatility
If percutaneous access is used for adjustability, then surgical invasiveness is reduced, but the risk of contamination increases
Solution Approach 1:
A needle or catheter serves as an intermediary tool to inject or withdraw fluid from the expandable member through the skin. This intermediary approach allows adjustment without direct surgical access, maintaining a closed system that minimizes contamination risk while enabling post-implantation modifications
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 spacer provides secure, adjustable, and minimally invasive distraction of vertebrae, reducing the risk of mechanical failure and allergic reactions, while allowing for non-surgical adjustments to maintain optimal spacing and alleviate pressure on spinal nerves.
Implementation Method 1
Inflation of the expandable member by introduction of a flowable material enlarges an end of the expandable member and causes the operative panels to pivot or move thereby increasing the height of the anchor members
Data Source
AI summary
An interspinous process spacer for distraction of the vertebra including a body portion having an operative panel for increasing the height thereof and defining an internal void in which an expandable member is provided for actuating the operative panel. A self sealing percutaneous access port is provided to enlarge the expandable member and actuate the operative panel. The body portion is anchored by flanges secured to adjacent spinous process. The port allows for adding or removing fluid from the one or more chambers or envelopes of the expandable member in order to adjust the height of the body and thus the interspinous process spacing. Subsequent to initial implantation and expansion the volume of the expandable member may be increased or decreased in a non-surgical in-office procedure in which a needle is used to add or remove fluid from the expandable member via the port and tubular member.