Expandable Spinal Access Device with Adjustable Length
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Solution Overview
Problem
Traditional spinal surgery methods cause significant trauma due to large incisions and muscle stripping, leading to scarring, pain, and extended recovery times, and existing minimally invasive techniques are inadequate for procedures requiring visualization of multiple vertebrae and introduction of large spinal fixation devices.
Innovation Solution
A surgical access device with an elongate body that expands within the patient to increase the cross-sectional area of the passage, allowing for a single access point for multiple procedures, and an adjustable length to accommodate different anatomical needs and procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a narrow cannula is used to minimize incision size and muscle stripping, then trauma to the patient is reduced, but the surgical space for visualization and instrument manipulation becomes insufficient
Solution Approach 1:
The access device incorporates an expandable distal portion that can transition from a compressed low-profile configuration during insertion to an expanded configuration that provides adequate surgical space. This dynamic transformation allows the device to minimize trauma during insertion while creating sufficient working space for visualization and instrument manipulation once deployed.
Solution Approach 2:
The expandable distal portion is designed to be nested within a smaller delivery system or outer sheath during insertion, similar to nested dolls. The compressed state allows passage through a narrow incision, and upon deployment, the nested structure expands outward to provide the necessary surgical space while remaining contained within the access device.
2Ease of manufacture
If a constant diameter cannula is used to simplify the device structure, then manufacturing is easier, but the device cannot accommodate procedures requiring visualization of multiple vertebrae and introduction of large spinal fixation devices
Solution Approach 1:
The access device transitions from a constant diameter design to a variable diameter design with an expandable distal portion. This allows the device to be manufactured with a simple compressed profile for insertion, then dynamically expand to provide different diameters and cross-sectional areas at the distal end to accommodate various surgical instruments and provide adequate visualization space for multiple vertebrae.
Solution Approach 2:
The access device is segmented into distinct functional portions: a proximal portion with constant diameter for stable insertion and anchoring, and a distal portion that can expand to variable dimensions. This segmentation allows each portion to be optimized for its specific function while maintaining overall device manufacturability.
3Area of stationary object
If the passage cross-sectional area is increased to accommodate large spinal fixation devices, then instrument access is improved, but the incision size and muscle stripping must be increased
Solution Approach 1:
The access device maintains a small profile during insertion to minimize incision size and muscle stripping, then dynamically expands at the distal portion to provide a large passage cross-sectional area for instrument access. This temporal separation of size requirements allows adequate surgical space without requiring large initial incisions.
Solution Approach 2:
The access device transitions from a one-dimensional size constraint (incision diameter) to a three-dimensional solution by expanding the distal portion radially outward within the body cavity. This dimensional transformation allows the passage cross-sectional area to increase without proportionally increasing the incision size, as the expansion occurs in the radial dimension after insertion.
4Device complexity
If the access device length is fixed to simplify design, then device complexity is reduced, but the device cannot accommodate different anatomical needs and procedure requirements
Solution Approach 1:
The access device incorporates an adjustable length mechanism that allows the distal portion to be positioned at variable depths relative to the proximal end. This dynamic adjustment capability enables the device to accommodate different anatomical configurations and procedure requirements without requiring multiple fixed-length devices, balancing design simplicity with versatility.
Data Source
AI summary
A device for providing access to a surgical location within a patient is provided. The device includes an elongate body and a sleeve. The elongate body has an outer surface, an inner surface, and a distal portion. The inner surface defines a passage that extends through the elongate body along a longitudinal axis through which surgical instruments can be inserted to the surgical location. The distal portion is capable of having an expanded configuration when inserted within the patient. In the expanded configuration, the cross-sectional area of the passage at a first location is greater than the cross-sectional area of the passage at a second location, wherein the first location is distal to the second location. The sleeve is configured to be moved relative to the elongate body along the longitudinal axis to increase or to decrease the length of the passage along the longitudinal axis.