Patent Application
20070099882
This invention relates to methods and compositions for prolonged alleviation of chronic articular joint pain due to arthritis or other chronic inflammatory processes involving joints and joint tissue structures using an injectable mixture of an anesthetic and selected corticosteroids.
There are many medications, remedies, chiropractic, and traditional Chinese medical manipulative interventions that are used to treat the pain associated with articular joint abnormalities, chronic inflammation, and arthritis. The available interrogative methods generally available for localizing the specific foci of pain and medical/surgical treatments may fail to lead to relatively long term pain relief.
There exists difficulties that are often encountered in the identification of the specific foci and pain triggers, preoperative and postoperative, involving joint structures of the body, including the spine, which are commonly examined by palpation, manipulation, X-ray, cat scan, and MRI whereby lesions of variable duration may be identified but are not necessarily the area of pain. Such abnormal findings may or may not accurately localize the specific foci of pain production nor the bio-molecular cause of pain as some tissue accretions may exist for indeterminate periods of time without causing pain.
In addition, among the common protocols for treating articular joint pain is through surgical and specific medical interventions that subject patients to unfavorable risks.
The traditional use of corticosteroid joint injections alone or in combination with local anesthetics, such as Lidocaine and other local anesthetics, do not consistently confer long term pain relief. The doses required to obtain pain relief of a temporary duration are limited by the potential for iatrogenic complications involving adrenal gland function (Cushing's disease). Additionally, it is observed that the benefits in relieving joint pain using standard Lidocaine or Marcaine combinations with high dosages of single joint compatible corticosteroids are variable in response and commonly of short duration. Others have attempted to alleviate articular joint pain by injecting a mixture containing a single corticosteroid with an anesthetic with limited results.
Information relevant to attempts to address these problems can be found in the U.S. Patent Application Nos. 20040047807 filed 11 Aug. 2003 by Meyer; 20040152713 filed 21 Jan. 2004 by Petrie; 20040022847 filed 29 Jul. 2003 by Leneau; and 20030232784 filed 14 Jun. 2002 by Benedict.
Therefore, there is a need for treatment methods and compositions for alleviating articular joint pain with prolonged effects that does not cause adrenal gland complications and that does not require surgery.
The above described problems are solved and a technical advance achieved by the methods and compositions for prolonged alleviation of articular joint pain that provide a method for localizing specific anatomical sites of pain while concurrently providing an extended period of relief from pain.
The locations of pain appropriate for this method include joint tissues, calcified connective tendons, ligaments associated joint structures, nerve impingements associated with local inflammation, chronic cellular tissue restrictions which interfere with joint mobility, range of motion, and arthritic aggregates.
The method for prolonged alleviation of articular joint pain specifically identifies the trigger location of pain and in this regard becomes a diagnostic tool. When the invention is applied by local injections the pain is relieved for substantially prolonged periods of time, often eliminating the necessity of using systemic drugs or other interventions. In addition, this method is designed to address the problem of chronic pain in cases where surgical and specific medical interventions have not been successful and cases where the patient is put to unfavorable risk.
The method is based upon the discovery that very small doses of the local anesthetic, such as 4% Procaine, in combination with joint compatible corticosteroids, such as Depomedrol and Betamethasone, administered by intra articular injection provides relief from acute joint pain or associated tissue structures and the duration of relief from pain is prolonged for several years.
The mechanism of action of Procaine when used in combination with appropriate joint compatible corticosteroids is clearly different clinically from that of other local anesthetics, which provide temporary relief at best. The use of the method for prolonged alleviation of articular joint pain in cases of severe capsular or tissue fibrosis and osteogenic proliferations is most effective when injected into the joint space or areas of inflammatory impingement.
The methods and compositions for prolonged alleviation of articular joint pain alleviate chronic and acute joint pain for a period of years when injected into the intro articular joint space and other areas of chronic pain.
The invention provides methods and compositions for alleviating articular and connective tissue pain in a joint of a patient, the method comprising preparing a treatment solution containing at least one anesthetic and at least two joint, connective tissue, or synovia compatible corticosteroids, and administering said treatment solution through an area of skin the target area. Preferably, the method further comprises disinfecting the area of skin of the patient prior to the administering of the treatment solution. Preferably, the at least one anesthetic is Procaine. Preferably, the at least two joint, connective tissue, or synovia compatible corticosteroid is selected from the group consisting of Betamethasone, Depomedrol, and Cortisone acetate. Preferably, the at least two joint, connective tissue, or synovia compatible corticosteroids are Betamethasone and Depomedrol. Preferably, the at least one anesthetic is present in the treatment solution in the range of from about 10 to about 70 percent by volume, based on the total volume of the treatment solution. Preferably, the at least one anesthetic is present in the treatment solution in the range of from about 30 to about 50 percent by volume, based on the total volume of the treatment solution. Preferably, the at least one anesthetic is 40 percent by volume in the treatment solution, based on the total volume of the treatment solution. Preferably, the at least two corticosteroid is each present in the treatment solution in the range of from about 10 to about 50 percent by volume, based on the total volume of the treatment solution. Preferably, the at least two corticosteroid is each present in the treatment solution in the range of from about 20 to about 40 percent by volume, based on the total volume of the treatment solution. Preferably, the at least two corticosteroid is each present in the treatment solution at 30 percent by volume, based on the total volume of the treatment solution. Preferably, the administering comprises injecting the treatment solution into the joint of the patient. Preferably, the injecting is performed by a needle and syringe. Preferably, the needle is between ¾ and 1½ inches in length. Preferably, the needle is between 22 and 25 gauge in diameter. Preferably, the joint is selected from the group consisting of scapular humeral joint, elbow joint, carpal joint, stifle joint, coxofemoral joint, temporomandibular joint, and hock joint. Preferably, the administering further comprises administering a first treatment solution into the joint cavity of the joint and then administering a second treatment solution into the joint cavity of the joint approximately thirty days later.
The terms “treat”, “treatment,” and “treating” include preventative (e.g., prophylactic) and palliative treatment or the act of providing preventative or palliative treatment. In the present method for prolonged alleviation of chronic articular joint pain, these terms include the amelioration of joint pain, which means the methods of the present invention are effective in reducing the intensity of the joint pain. The term “pain” is used in the general sense and is meant to encompass pain levels from the merely uncomfortable to the virtually unbearable. The term “joint pain” is used to identify pain in the joint areas of the afflicted patient, such as, but not limited to, pain in the finger, toe, wrist, elbow, shoulder, hip, knee, or ankle joints. The term “patient” means animals, particularly mammals and including humans.
The term “joint cavity,” joint space,” and “joint capsule” mean a hollow place or depression in the place of union or junction between two or more bones of the skeleton, including the space of a synovial joint, enclosed by the synovial membrane and articular cartilages.
The term “anesthetics” means generally compounds that are characterized by or produce anesthesia, particularly drugs and agents used to abolish the sensation of pain. This includes agents whose anesthetic action is limited to an area of the body determined by the site of its application or injection. The term “corticosteroid” means any of the steroids elaborated by the adrenal cortex, excluding the sex hormones of adrenal origin, in response to the release of corticotropin by the pituitary gland and the synthetic equivalents of these steroids. The term “injection” means the act of forcing liquid into a part, as into the subcutaneous tissues, of the body, particularly with a syringe needle.
The present methods and compositions for prolonged alleviation of chronic articular joint pain due is both diagnostic and therapeutic. Regarding the former, many patients presented with joint pain, very often are found to have locations clearly painful and other locations which manifest questionable sensitivity upon palpation and manipulation. It has been discovered that if the most painful areas located are injected with the treatment composition, a dramatic improvement is noted if that site is primary. On the other hand, if a secondary location is also causing pain, then the symptoms of lameness may shift from anterior to posterior or from side to side away from the originally injected locations. Also, in cases where there is a neurological component causing debilitation, nullifying the joint symptoms will not be successful. Based upon these observations, it is important to either perform anesthesia of the specific joints in sequence or utilize the invention sequentially to clearly establish efficacy and accuracy of diagnosis. The present methods and compositions for prolonged alleviation of chronic articular joint pain is therapeutic for patient's with joint pain. For example, when injected with the treatment composition, the patient will manifest clear relief from pain for ten to fourteen days, which may be followed by the return of some level of pain until preferably, the second injection is administered preferably thirty days after the first injection.
The joints shown in
The solutions used in this method, compositions and kits, are preferably administered locally, preferably by an instrument of injecting liquids into a joint cavity according to conventional methods. In one embodiment of the present method, the solution is directly injected via a syringe needle into the joint space of the painful (arthritic) or connective tissue target of the patient. The size of the syringe needle is determined by the health professional administering the solution and the amount of solution to be injected into the painful (arthritic) or connective tissue target of the patient. Preferably, the syringe is capable of containing at least 0.1 cc of liquid and administering the liquid subcutaneously into the joint space of the patient via a syringe needle.
The typical volumes of solution injected into the painful (arthritic) or connective tissue target of the patient ranges from 0.1 cc to 2.5 cc of solution per administration, depending on the size of the joint being treated. Preferably, the solution volume is ranges between 0.5 cc to 1.5 cc of solution and most preferably, the volume is 1.0 cc of solution.
The anesthetic component of the solution dosage typically comprises at least one anesthetic that preferably has a volume that is between 20% to 60% of the total solution volume of each solution dosage. More preferably, the anesthetic component is approximately 40% of the total solution volume of each solution dosage. The corticosteroid component of the solution dosage typically comprises at least two corticosteroids, each corticosteroid component preferably has a volume that is between 10% to 50% of the total solution volume of each solution dosage. More preferably, each corticosteroid component is approximately 30% of the total solution volume for each solution dosage.
The anesthetic component of the solution of the present method is selected based on the desired duration of pain relief provided to the painful (arthritic) or connective tissue target of the patient. Exemplary anesthetic compounds include procaine hydrochloride (“Procaine”). In one embodiment of the present method, Procaine is used and has the formula C6H4NH2COOCH2CH2N(C2H5)2.HCl. Preferably, the Procaine is prepared in a 4% solution and then the desired volume of this 4% solution is then mixed into the solution with the corticosteroids portion.
The joint, connective tissue, or synovia compatible corticosteroids components of the present method are selected from the group consisting of Betamethasone, Methylprednisolone acetate (“Depomedrol”), Cortisone acetate, Dexamethasone, Hydrocortisone, Methylprednisolone, Prednisolone, Prednisolone sodium phosphate, and Prednisone. In one embodiment of the present method corticosteroids component includes a mixture of Dexamethasone and Depomedrol. In one embodiment of the method the anesthetic is buffered.
The needle of the syringe needle of the present method is selected based on the size of the joint space of the painful (arthritic) or connective tissue target of the patient. In one embodiment of the present method the needle is a hypodermic needle, preferably an arthroscopic needle, but may be other types of needles depending on the application including non-arthroscopic needles. Preferably, the present method provides for needle gauges in the range of between 22 and 25 gauge and from ¾ inch to 1½ inches in length.
In step 1104, the joint is opened for syringe needle access to a joint or tendon sheath interior. This is done by manipulating the bones that define the joint such that access with a syringe needle to the joint or tendon sheath interior can be achieved.
In step 1106, the injection site on the skin is aseptically prepared in a routine fashion to maintain sterility. This is done by cleaning and preparing the site of injection using methods, techniques, and preparations commonly used in the medical arts. Some exemplary topical solutions for disinfection of the site of the injection includes alcohol and betadyne scrub.
In step 1108, the treatment solution is injected into the joint. Preferably, this is done by inserting the syringe needle through the treated topical skin area and then slowly guiding the needle of the syringe needle into the synovia capsule of the target joint. Depending upon the joint or target space capacity, preferably 1.0 ml or slightly less of the present treatment composition is introduced slowly into the joint capsule.
In step 1110, preferably, a second injection is administered 30 days after the first injection. The present method for prolonged alleviation of articular joint pain provides for administering a first injection containing a solution as described herein to the painful (arthritic) or connective tissue target of the patient to provide for a limited duration of pain alleviation. The first injection of the Procaine combination results in an initial pain reduction or elimination for a period of 10-14 days, or longer, after which discomfort or pain may return but at generally a reduced intensity. The present method further provides for administering a second injection containing the same solution in the same site as described herein to the affected joint to provide for significantly longer duration pain alleviation, for example up to 2-4 years, or longer. Experience with this procedure showed that the thirty day interval between injections is very important. Preferably the second injection is administered no sooner than 30 days from the first injection, though shorter periods of time between the two injections does provide substantially improved pain alleviation over the prior art. Additional injections into the painful (arthritic) or connective tissue target of the patient may be necessary due to the condition of the painful (arthritic) or connective tissue target of the patient.
The solution can be mixed in a separate container prior to be loaded into a syringe or they can be mixed in the syringe directly prior to administration.
By way of non-limiting examples, the following treatments are provided to further describe the present method for prolonged treating chronic articular joint pain.
A solution containing 0.4 cc of buffered Procaine combined with 0.3 cc of Depomedrol and 0.3 cc of Betamethasone was prepared and loaded into a syringe having a ¾ inch 22 gauge needle. The skin over the injection site was prepared by disinfection with an appropriate topical solution or scrub. The scapular humeral joint arthritis (shoulder) and bicipital tendon (calcified or uncalcified) was slightly flexed and the syringe needle was directed towards the joint from an anterior lateral direction to the joint space. The introduction of the solution was administered slowly into the joint space or synovial space of the joint. This comprised the first injection of the method for prolonged treating chronic articular joint pain. A second injection was prepared and administered similarly to the first injection to the joint 30 days later.
A solution containing 0.4 cc of buffered Procaine combined with 0.3 cc of Depomedrol and 0.3 cc of Betamethasone was prepared and loaded into a syringe having a ¾ inch 22 gauge needle. The skin over the injection site was prepared by disinfection with an appropriate topical solution or scrub. The elbow joint was slightly flexed approximately ninety degrees so that the joint space could be accessed either from the posterior lateral or lateral direction and the syringe needle was directed towards the joint from the posterior lateral direction to the joint space. The introduction of the solution was administered slowly into the joint space or synovial space of the joint. This comprised the first injection of the method for prolonged treating chronic articular joint pain. A second injection was prepared and administered similarly to the first injection to the joint 30 days later. In very small joints a 25 gauge needle may be substituted.
A solution containing 0.4 cc of buffered Procaine combined with 0.3 cc of Depomedrol and 0.3 cc of Betamethasone was prepared and loaded into a syringe having a ¾ inch 22 gauge needle. The skin over the injection site was prepared by disinfection with an appropriate topical solution or scrub. The carpal joint was slightly flexed so that the joint space to facilitate an anterior approach of the needle to the medial or lateral joint compartment. The introduction of the solution was administered slowly into the joint space or synovial space of the joint. This comprised the first injection of the method for prolonged treating chronic articular joint pain. A second injection was prepared and administered similarly to the first injection to the joint 30 days later. In very small joints a reduced volume of the solution may be preferred.
A solution containing 0.4 cc of buffered Procaine combined with 0.3 cc of Depomedrol and 0.3 cc of Betamethasone was prepared and loaded into a syringe having a ¾ inch 22 gauge needle. The skin over the injection site was prepared by disinfection with an appropriate topical solution or scrub. The stifle joint was positioned to facilitate an anterior lateral or medial approach of the needle to either side of the patellar ligament. The introduction of the solution was administered slowly into the joint space or synovial space of the joint. This comprised the first injection of the method for prolonged treating chronic articular joint pain. A second injection was prepared and administered similarly to the first injection to the joint 30 days later. This joint is commonly involved in post operative and chronically destabilized joints where the cranial cruciate ligament has been ruptured, with or without damage to the medial meniscus.
A solution containing 0.4 cc of buffered Procaine combined with 0.3 cc of Depomedrol and 0.3 cc of Betamethasone was prepared and loaded into a syringe having a ¾ inch 22 gauge needle. The skin over the injection site was prepared by disinfection with an appropriate topical solution or scrub. The coxofemoral joint was slightly positioned so that the anterior edge of the greater trochanter is used as a guide point. The needle is introduced just anterior to the greater trochanter and then penetrated directly into the joint space, using the neck of the femoral head to move into the joint space. The introduction of the solution was administered slowly into the joint space or synovial space of the joint. This comprised the first injection of the method for prolonged treating chronic articular joint pain. A second injection was prepared and administered similarly to the first injection to the joint 30 days later. In this joint it is common to locate a markedly thickened joint capsular area through which the needle is moved. In very small joints a 25 gauge needle may be substituted.
A solution containing 0.4 cc of buffered Procaine combined with 0.3 cc of Depomedrol and 0.3 cc of Betamethasone was prepared and loaded into a syringe having a ¾ inch 22 gauge needle. The skin over the injection site was prepared by disinfection with an appropriate topical solution or scrub. The hock joint (ankle) was positioned so that the joint space of the tibial or tarsal joint to facilitate a posterior approach of the needle to the medial or lateral joint compartment. The introduction of the solution was administered slowly into the joint space or synovial space of the joint. This comprised the first injection of the method for prolonged treating chronic articular joint pain. A second injection was prepared and administered similarly to the first injection to the joint approximately 30 days later.
There have been described novel methods and compositions for prolonged alleviation of articular joint pain. It should be understood that the specific formulations and methods described herein are exemplary and should not be construed to limit the invention, which will be described in the claims below. Further, it is evident that those skilled in the art may now make numerous uses and modifications of the specific embodiments described without departing from the inventive concepts. For example, preparation of the treatment solution described herein, can also be prepared by any one of the other commonly known methods. Consequently, the invention is to be construed as embracing each and every novel feature and novel combination of features present in and/or possessed by the compositions and methods described and by their equivalents.
