Method of treating pain

Details Method of treating pain Method of treating pain

2002-01-31

2004-10-19

Housel, James (Department: 1648)

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Peptide containing doai

C424S247100, C530S350000, C128S907000

Reexamination Certificate

active

06806251

ABSTRACT:

FIELD OF THE INVENTION
The present invention is directed to the injection of a paralyzing agent into the intrinsic spinal muscles to treat chronic pain.
BACKGROUND OF THE INVENTION
Chronic pain may be generally described as any pain that persists beyond the usual course of a disease or beyond the reasonable time for an injury to heal. Chronic pain negatively impacts all aspects of an individual's life, including emotional, vocational, financial and social elements.
A very common type of chronic pain is back pain or spinal pain. The spine is a column of bone and cartilage that extends from the base of the skull to the pelvis. It encloses and protects the spinal cord and supports the trunk of the body and the head. The spine comprises approximately thirty-three vertebrae. A joint, which stabilizes the vertebral column and allows it to move, connects each pair of vertebrae. Between each pair of vertebrae is a disk-shaped pad of fibrous cartilage with a jelly-like core, which is called the intervertebral disk, or usually just the “disk”. These disks cushion the vertebrae during movement.
There are deep spinal muscles surrounding the vertebrae and disks. These muscles are herein referred to as “intrinsic spinal muscles” because they are intrinsic or interwoven within the spine. Over time, or in response to injury, these muscles may become shortened and contribute to myofascial pain.
Many different therapies and products have been tried in the treatment of chronic pain. One promising product, called Botox™, is a commercial product based on botulinum toxin. Botulinum toxin is produced by the bacteria,
Clostridium botulinum
. When injected into a muscle, the toxin prevents the release of acetylcholine and thus the muscle cannot contract.
U.S. Pat. No. 5,766,605 describes the use of botulinum toxin to control autonomic nerve function in a mammal. It has been found useful for conditions such as rhinorrhea, excessive salivation, asthma and excessive sweating.
U.S. Pat. No. 5,989,545 discloses Clostridial toxin derivatives which are able to modify peripheral sensory afferent functions. A targeting moiety is coupled to the toxin to direct the toxin and reduce side effects.
U.S. Pat. Nos. 6,113,915 and 6,235,289 are directed to methods of treating pain by intrathecal administration of botulinum toxin type A. The toxin is administered to the intrathecal space between the arachnoid membrane and the pia mater.
Although the use of botulinum toxin in the treatment of chronic pain is known, there can be serious side effects associated with the known methods of use. Unless the toxin is very specifically delivered to a particular muscle, there can be diffusion effects. Botulinum toxin is a very powerful paralytic poison and naturally the more that is administered to allow sufficient binding to the muscle, the greater the risk of inappropriate paralysis. The toxin's effect generally lasts about three months and is not reversible. For example, the use of Botulinum toxin for the treatment of facial lines has sometimes had the undesirable effect of facial or eyelid drooping, or lack of control of important muscles for smiling, etc. Thus, it is clearly apparent that if Botulinum toxin is to be used in the spinal area to treat chronic pain, new and improved methods are required.
SUMMARY OF THE INVENTION
The present invention is directed to a novel method for treating pain using botulinum toxin. Particularly, it applies to the application of Botulinum toxin to treat herniated disks, spinal neuropathy, compressed and degenerated disks of the spine, and facet joint disease of the spine as caused by intrinsic spinal muscle dysfunction, and the complications thereof. The method is generally referred to as specific deep paraspinal paralysis.
In one aspect, the method of the present invention comprises administering to the intrinsic spinal muscles of a mammal an amount of a toxin sufficient to paralyze the muscles. This prevents the muscles from shortening and can allow healing to occur.
In a preferred embodiment, the toxin is botulinum toxin type A. The toxin may be administered as a single dose or in a number of injections.
In another aspect, the present invention provides for the use of botulinum toxin as an agent for the injection of an intrinsic spinal muscle.
In a further aspect of the invention, a paralyzing agent is used in combination with a growth factor to treat spinal compression.
In yet another aspect of the invention, a kit for the treatment of pain by injection of the intrinsic spinal muscles is provided. The kit comprises:
a) a paralyzing agent;
b) an injection syringe with needle; and
c) an acupuncture needle with injector system.
In a preferred embodiment the kit comprises:
a) botulinum toxin;
b) saline for diluting the toxin;
c) a syringe with needle for dispensing the saline into the toxin;
d) a spinal botulinum injection needle;
e) an acupuncture needle with spinal acupuncture injector system; and
f) at least one injection syringe.
Preferably the botulinum toxin is provided in a vial containing 25, 50, 75 or 100 units and the the acupunture needle is a 21/2″—50-60 mm acupuncture 0.25 mm gauge needle with injector system. The kit may also include a local anesthetic such as Naropin, Xylocaine or Marcaine or other local anesthetic. An instructional video for physicians demonstrating injection of intrinsic muscles in the cervical, thoracic or lumber areas may also be provided.


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