Hydrogel Prosthesis Injection via Sizing Balloon
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Solution Overview
Problem
Current treatments for chronic back pain due to intervertebral disc degeneration lack effective methods for restoring the natural mechanical properties of the nucleus pulposus, leading to inadequate relief and further degeneration of the annulus fibrosus.
Innovation Solution
A method and apparatus for injecting a hydrogel prosthesis into the nucleus pulposus region of an intervertebral disc, using an insertion cannula and a sizing balloon to determine and measure the volume of the hydrogel needed to restore the natural mechanical properties, allowing for controlled and precise implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conservative bed rest or highly invasive surgical procedures are used to treat chronic back pain, then pain relief may be achieved, but the natural mechanical properties of the intervertebral disc are not restored and further degeneration occurs
Solution Approach 1:
The invention extracts only the degenerated nucleus pulposus tissue and replaces it with a hydrogel prosthesis, rather than performing full disc replacement or fusion. This selective extraction approach maintains the natural annulus fibrosus and surrounding disc structures intact, preserving the disc's natural mechanical properties while providing effective pain relief through nucleus replacement alone
Solution Approach 2:
The invention changes the physical and chemical parameters of the nucleus pulposus by replacing degenerated tissue with a hydrogel prosthesis that mimics the mechanical properties of healthy nucleus tissue. The hydrogel's water content, elasticity, and compressibility are specifically tuned to match natural nucleus parameters, thereby restoring the disc's mechanical function without invasive fusion procedures
2Stability of the object's composition
If hydrogel prosthesis is injected into the nucleus pulposus region, then the natural mechanical properties can be restored, but precise determination of the required volume is challenging
Solution Approach 1:
The invention performs preliminary measurement of the nucleus pulposus cavity volume using a sizing balloon before injecting the hydrogel prosthesis. This preliminary action allows the surgeon to determine the exact volume needed to fill the cavity, ensuring that the hydrogel volume is precisely matched to the patient's anatomical requirements and avoiding both underfilling and overfilling
Solution Approach 2:
The invention introduces a sizing balloon as an intermediary tool between the cavity measurement and hydrogel injection processes. The balloon serves as a mediator to transfer volume information from the cavity to the injection system, enabling precise volume determination through balloon expansion and fluid displacement measurement before the actual hydrogel implantation
3Object-affected harmful factors
If a small portal is used for hydrogel injection, then tissue damage is minimized, but controlled and precise passage of the hydrogel prosthesis becomes difficult
Solution Approach 1:
The invention segments the injection process into distinct stages: first inserting a sizing balloon through the small portal to measure cavity volume, then injecting the hydrogel prosthesis in a controlled manner based on the pre-determined volume. This segmentation allows the small portal to be used effectively without requiring large incisions, while maintaining control through staged procedures
Solution Approach 2:
The invention replaces complex mechanical manipulation systems with a fluid pressure-driven injection system. Instead of mechanically pushing or forcing the hydrogel through the small portal, a controlled fluid pressure source drives the hydrogel through the needle and into the nucleus pulposus cavity, enabling precise and controlled passage through the minimally invasive portal
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 the restoration of the natural mechanical properties of the intervertebral disc by accurately determining and implanting the appropriate volume of hydrogel, relieving pain and preventing further degeneration.
Implementation Method 1
A sizing balloon and associated cannula are inserted through the insertion cannula into the nucleus region of the intervertebral disc and are inflated therein with a measurable volume of a fluid in order to determine the amount of hydrogel prosthesis to be injected
Implementation Method 2
apparatus for injecting a low modulus spinal implant into an intervertebral disc through a small portal
Data Source
AI summary
An instrument for inserting an elongated hydrogel prosthesis into an intervertebral disc includes an insertion cannula that is inserted through the annulus fibrosus of an intervertebral disc to provide access to the nucleus region of the disc, an elongated hydrogel prosthesis packaged within a tubular container adapted to be coupled to a proximal end of the insertion cannula, and a source of fluid pressure adapted to be coupled to a proximal end of the tubular container. Auxiliary instruments for use in convenient insertion of the insertion cannula through the nucleus pulposus and providing for a complete and controlled passage of the hydrogel prosthesis through the insertion cannula are provided in a kit with the insertion cannula. A sizing apparatus for determining the volume of prosthesis to be inserted includes a catheter or cannula capable of being inserted through the insertion cannula into the nucleus region of the intervertebral disc and having at its distal end a balloon capable of being inflated within the intervertebral disc with a measurable volume of a fluid in order to determine the amount of hydrogel prosthesis to be injected.