Intervertebral Disc Puncture and Treatment System

Abstract

A pre-assembled, telescoping needle system comprising an outer needle surrounding a finer gauge needle which, after percutaneous penetration by the outer needle, extends to penetrate the intervertebral disc into which the injectable is to be delivered.

Description

BACKGROUND OF THE INVENTION[0001]The natural intervertebral disc contains a jelly-like nucleus pulposus surrounded by a fibrous annulus fibrosus. Under an axial load, the nucleus pulposus compresses and radially transfers that load to the annulus fibrosus. The laminated nature of the annulus fibrosus provides it with a high tensile strength and so allows it to expand radially in response to this transferred load.[0002]In a healthy intervertebral disc, cells within the nucleus pulposus produce an extracellular matrix (ECM) containing a high percentage of proteoglycans. These proteoglycans contain sulfated functional groups that retain water, thereby providing the nucleus pulposus with its cushioning qualities. These nucleus pulposus cells may also secrete small amounts of cytokines as well as matrix metalloproteinases (“MMPs”). These cytokines and MMPs help regulate the metabolism of the nucleus pulposus cells.[0003]In some instances of disc degeneration disease (DDD), gradual degene...

AI Technical Summary

Benefits of technology

[0011]It is an object of the present invention to provide simple and safe percutaneous access to the intervertebral disc for intradiscal delivery of therapeutic agents to the disc.

[0013]The needle system of the present invention provides a number of advantages over the conventional intradiscal needle systems.

[0015]Second, there is a reduced risk of discitis (intradiscal infection). The inner injection needle is shielded by the outer cannula from contact or exposure to the operative environment, skin and soft inner tissues. This reduced exposure yields a reduced infection potential.

Problems solved by technology

In other instances of DDD, genetic factors, such as programmed cell death, or apoptosis can also cause the cells within the nucleus pulposus to emit toxic amounts of these cytokines and MMPs.

In some instances, the pumping action of the disc may malfunction (due to, for example, a decrease in the proteoglycan concentration within the nucleus pulposus), thereby retarding the flow of nutrients into the disc as well as the flow of waste products out of the disc.

This reduced capacity to eliminate waste may result in the accumulation of high levels of toxins.

In particular, the MMPs (under mediation by the cytokines) begin cleaving the water-retaining portions of the proteoglycans, thereby reducing their water-retaining capabilities.

This degradation leads to a less flexible nucleus pulposus, and so changes the load pattern within the disc, thereby possibly causing delamination of the annulus fibrosus.

These changes cause more mechanical instability, thereby causing the cells to emit even more cytokines, typically thereby upregulating MMPs.

As this destructive cascade continues and DDD further progresses, the disc begins to bulge (“a herniated disc”), and then ultimately ruptures, causing the nucleus pulposus to contact the spinal cord and produce pain.

However, the drawbacks of this approach include the need for a relatively sturdy needle and an increase in the risk of infection to the disc (due to the fact that the needle that pierces the skin is also the needle that enters the disc).

However, this approach requires two separate needles and manual insertion of the second needle inside of the first.

However, these systems do not allow for aspiration of the medicament into an attached syringe.

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