Drug – bio-affecting and body treating compositions – Lymphokine
Reexamination Certificate
2001-02-02
2003-11-11
Kunz, Gary (Department: 1647)
Drug, bio-affecting and body treating compositions
Lymphokine
C424S426000, C514S012200, C514S886000, C530S840000
Reexamination Certificate
active
06645485
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a process of treating inflammation in a joint, such as but not limited to a knee joint, a hip joint or an ankle joint, which has been damaged or which has otherwise become defective, and thereby, alleviating pain, heat, redness, swelling, stiffness, and other difficulties typically associated with a damaged or defective articular cartilage surface in a joint. More in particular, the present invention is directed to a process of injecting a mixture of purified growth hormone (commonly known as somatotropin) and a buffer solution into the joint of a body, preferably but not limited to that of a human, so as to initiate the treatment process.
2. Description of the Related Art
The ends of bones which form a joint, including vertebra, are covered by articular cartilage, which is a thin, fragile tissue layer and which allows the bone ends to move freely and without pain. Many arthritic diseases and many degrees of trauma can, however, cause destruction or deterioration of this fragile layer. From ancient times and continuing in the present day, people have suffered through varying degrees of heat, redness, pain, swelling and/or stiffness of the joints, any one or all of which can often be associated with deterioration of the articular cartilage in the joints, whether those joints are associated with walking, such as the hip, knee or ankle joints or others, such as the vertebra of the spine, the shoulder, elbow or wrist joints and fingers. Regardless, damage to and/or the deterioration of articular cartilage in a joint is often, if not always accompanied by inflammation. Inflammation, which is typically thought of as heat, redness, pain, swelling and/or stiffness, when experienced in a joint, can be crippling.
As a result, many have tried to develop ways to alleviate the pain and inflammation associated with arthritis and other damage to the joints. A number of these efforts have focused on oral medications such as cortisone derivatives (steroids) and numerous non-steroidal anti-inflammatory drugs (NSAIDs), all of which have potentially serious side effects. Other efforts have focused on implants of entire joints, such as the knee or hip, although typically, a lengthy and complicated surgical procedure is required, with the patient being forced to undergo a significant recovery period, including a rigorous and costly regimen of physical therapy thereafter. Most often, full motion and full activity are not achieved with the use of these implants. While medical science has recently developed a variety of new materials for the joint implants, these implants are often more costly, offer results which may be only marginally better than those obtained previously, and do nothing to avoid the hospitalization required for the surgical implantation of them nor the long periods of rehabilitation. In addition, it is also possible that one or more revision surgeries will be needed to replace defective, loose or infected implants. Further, the general discomfort which might be associated with utilizing such implants makes an alternative method all the more desirable.
The biological action of growth hormone, namely, somatotropin, has been the subject of the inventor's research. Heretofore, growth hormone has been used clinically to enhance the growth of children with short stature. Somatotropin may have other effects on other organ systems but in the instant application for a patent, the specific actions of somatotropin related to its effects on articular cartilage have been focused on by Dunn's research and are utilized herein. The major targets of somatotropin activity are believed by the inventor hereof to be vascular sinusoids and sub-chondral vessels located at the cartilage-bone interface (sub-chondral bone) and the endothelial cells located therein, and in addition, nests of stem (pleuripotential) cells in various sites such as marrow; and the vascular system. More specifically, it is believed by the inventor hereof that growth hormone has the ability to stimulate proliferation of stem cells in the marrow and subchondral vessels and sinusoids. The inventor hereof has also shown that growth hormone has the ability to form vascular and multi-lumen sinusoids, known as Glomeruloids, from pre-existing and mature single lumen vessels in the sub-chondral bone. The inventor describes this action of growth hormone as Morphogenic Action, which is a type of rejuvenation of mature monolumen vessels into fetal-like and/or other immature chondrogenic vascular structures. This Morphogenic Action, a type of rejuvenation, can also dematurate a layer of mature sub-chondral bone into a cartilaginous state comparable to that observed in the neonatal and immature cartilaginous skeleton.
The method of this invention relies on a novel use of growth hormone, namely, somatotropin. More in particular, the method of the present invention is useful as an anti-inflammatory agent and is specifically adapted to treat inflammation (heat, redness, pain, swelling, stiffness, etc.) and/or pain associated with damaged and/or defective articular cartilage on or at a joint in a body through the injection directly into the joint of one or more dosages of purified growth hormone (somatotropin). There is no reliance on the transplantation of tissue and thus all of the detrimental conditions of rejection, immune reaction, and other causes of transplant failure are avoided. Similarly, the present invention does not require an individual to undergo a lengthy or complicated surgical procedure, such as those which accompany joint replacements.
Until the present invention, growth hormone has not, to the inventor's knowledge, ever been used to treat merely the inflammation of tissues such as the soft tissue components within and surrounding a joint, i.e., synovial lining, capsule, and ligaments and articular cartilage and/or the pain associated therewith. Of course, the inventor herein has heretofore focused on growth hormone as a means for regenerating articular cartilage in a joint, for which U.S. Pat. No. 5,368,051 was awarded, incorporated herein by reference, but he has since improved and refined the applications for which growth hormone may be used, as set forth in greater detail, below.
Accordingly, the method of the present invention provides a much needed improvement in the treatment and elimination of ailments associated with the deterioration or destruction of the articular cartilage surface of a joint, including pain, inflammation of the soft tissue components within and surrounding the joint, including heat, redness, pain, swelling or stiffness. The method of the present invention also is directed towards providing for the reappearance or increase of space between bone ends and restoration of normal alignment of a limb, such as a leg, and including the restoration of normal or nearly normal motion.
SUMMARY OF THE INVENTION
The present invention is directed towards a method of treating inflammation and pain in a joint separating two or more bones. It is pointed out that for purposes of this application, inflammation means pain, joint stiffness, redness, heat and/or swelling, etc.
The method comprises an initial step of dissolving a quantity of growth hormone in a buffer solution and then injecting the resulting mixture as a single loading dose into the joint cavity where it will lessen the inflammation of the synovial lining, joint capsule, ligaments and articular cartilage. If desired or needed, additional injections of growth hormone of a single dosage can be injected from one day to several weeks later and after a first set of single or multiple injections, several additional sets of single or multiple injections may be given so as to maintain any improvement of the function of the joint.
In one alternative embodiment, the method of the present invention may comprise an additional step of mixing an amount of Lidocaine, anywhere from about 0.5 milliliter to 10 milliliters, and ideally about 1 to 3 milliliters of Lidocaine w
Hamud Fozia
Kunz Gary
Malloy & Malloy P.A.
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