US 20100184685A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2010/0184685 A1 Zavala, JR. et al. (43) Pub. Date: Jul. 22, 2010 (54) SYSTEMS AND METHODS FORTREATING Publication Classification POST OPERATIVE, ACUTE, AND CHRONIC (51) Int. Cl. PAIN USING AN INTRA-MUSCULAR A638/16 (2006.01) CATHETERADMINISTRATED A6IP 29/00 (2006.01) COMBINATION OF A LOCAL ANESTHETIC A6M 25/00 (2006.01) AND ANEUROTOXIN PROTEIN (52) U.S. Cl. ........................................... 514/12: 604/523 (57) ABSTRACT (76) Inventors: Gerardo Zavala, JR., San Antonio, TX (US); Gerardo Zavala, SR. Systems, and methods for the use of Such systems, are San Antonio, TX (US) described that allow for the administration of a combination of a Sustained release local anesthetic compound (such as bupivicaine) through a catheter based administration device Correspondence Address: and direct visualization or percutaneous injection of a neuro JACKSON WALKER LLP toxic protein compound (such as botulinum toxin) for post 901 MAIN STREET, SUITE 6000 operative and refractory treated muscle pain and discomfort DALLAS, TX 75202-3797 (US) in patients having undergone spinal Surgery and other muscle splitting or treatments aimed at improving muscle pain. The (21) Appl. No.: 12/689,381 systems utilize specific catheter-based administration proto cols and methods for placement of the catheter in association with muscles Surrounding the spine and other anatomical (22) Filed: Jan. 19, 2010 sites within the patient. The utilization of an initial bolus of a specific combination of medications (local anesthetic com Related U.S. Application Data pound and\or neurotoxic protein compound) followed by a dosage pump administration through the catheter is antici (60) Provisional application No. 61/145,621, filed on Jan. pated. A variety of local anesthetics (in addition to bupivic 19, 2009, provisional application No. 61/257,724, aine) and a number of different neurotoxin proteins (in addi filed on Nov. 3, 2009, provisional application No. tion to the Botulinum toxin) may be utilized in the 61/295,960, filed on Jan. 18, 2010. medicament administration protocols described. infusion Pump Tube Intramuscular Catheter Patent Application Publication Jul. 22, 2010 Sheet 1 of 2 US 2010/O184685 A1 : 2 s is d3.5 is C is Patent Application Publication Jul. 22, 2010 Sheet 2 of 2 US 2010/O184685 A1 Z‘314 US 2010/0184685 A1 Jul. 22, 2010 SYSTEMS AND METHODS FOR TREATING especially the Surrounding muscle. Surgical pain and trauma POST OPERATIVE, ACUTE, AND CHRONIC is experienced not only by those muscles directly cut at the PAIN USING AN INTRA-MUSCULAR Surgical site but also indirectly to the Surrounding muscles CATHETERADMINISTRATED that tend to contract and/or stress in an effort to compensate COMBINATION OF A LOCAL ANESTHETIC for those muscles directly weakened by the Surgical proce AND ANEUROTOXIN PROTEIN dure. 0005. Therefore, while local anesthetics and general anal gesics can address pain associated with the post-operative 0001. This application claims priority to U.S. Provisional patient in the acute pain setting (4-6 hours post operative), Patent Application Ser. No. 61/145,621, filed Jan. 19, 2009, they often fail to fully address the ongoing pain that follows entitled SYSTEMS AND METHODS FOR TREATING the 4-6 hours directly post-Surgery, especially Surgery involv POST OPERATIVE, ACUTE, AND CHRONIC PAIN ing the muscles attached to the spine and other muscle split USING AN INTRA-MUSCULAR CATHETERADMINIS ting procedures. Therefore, it becomes necessary to repeat TERED COMBINATION OF ANESTHETIC AND ANEU administration of these pain relievers (local anesthetics and/ ROTOXIN PROTEIN, and U.S. Provisional Patent Applica or systemic analgesics and/or muscle relaxants) for extended tion Ser. No. 61/257,724, filed Nov. 3, 2009, entitled periods of time, and for longer than what might be preferred. SYSTEMS AND METHODS FOR TREATING POSTOP This is necessary because these medications alone fail to ERATIVE, ACUTE, AND CHRONIC PAIN USING AN address one or more of the ongoing causes of post-operative INTRA-MUSCULAR CATHETER ADMINISTERED pain, including that muscle spasm and pain deriving from the COMBINATION OF ANESTHETIC AND A NEURO direct and indirect trauma discussed above. TOXIN PROTEIN, and U.S. Provisional Patent Application 0006 For chronic muscular pain patients, current treat Ser. No. 61/295,960, filed Jan. 18, 2010, entitled DECREAS ments available are comprised of one or a combination of the ING POST OPERATIVE PAIN, the entire content of each is following: over-the-counter (“OtC) medications, prescrip hereby incorporated by reference. tion medication, occupational/physical therapy, massage treatments, and invasive anesthetic delivery treatments to the FIELD OF THE INVENTION epidural space, facet, or intramuscular spaces and other regionally affected areas. Although most patients’ symptoms 0002 The present invention relates generally to methods are improved with these interventions there remains a number for treating muscle pain related to spasm, post operative and of patients that would benefit from the introduction of a other types of muscle pain. The present invention relates more combination of catheter administration of anesthetic with specifically to systems and methods for treating post-opera neurotoxin protein. tive and chronic pain using a subfacial and intra-muscular 0007 Local anesthetics are agents which prevent trans catheter administered local anesthetic and injection of a neu mission of nerve impulses without causing unconsciousness. rotoxin protein. Local anesthetics typically act by binding to fast sodium channels from within (in an open state). Local anesthetics can BACKGROUND be either ester or amide based, or combination aminefester 0003. There is a need for the more effective administration based or natural anesthetics like saxitoxin and tetrodotoxin. of pain relief medication to two types of patients: 1) those Ester local anesthetics (for example, procaine, amethocaine, who have undergone Surgical and other muscle splitting pro cocaine) are generally unstable in solution but are fast-acting. cedures, especially those involving the spine and Surrounding Unfortunately allergic reactions are common with ester local tissue (i.e. post-operative patients); and 2) those patients who anesthetics. Amide local anesthetics (for example, lidocaine, have been refractory to current conventional treatments to prilocalne, bupivicaine, levobupivacaine, ropivacaine and alleviate muscle pain (i.e. chronic pain Sufferers). At present, dibucaine) are generally heat-stable, with a long shelf life most treatment protocols call for the intermittent, or periodic, (around 2 years). They have a slower onset and longer half administration of local anesthetic compounds to the Surgical life than ester anesthetics. These agents are generally used site or area of pain in order to alleviate pain as it arises in a within regional and epidural or spinal techniques, due to their postoperative or conventionally-treated chronic muscular longer duration of action, which can often provide adequate pain patient. In some cases, systems have been developed for analgesia for Surgery, labor, and symptomatic relief. the administration of a Sustained release of a local anesthetic 0008 Lidocaine (as an example) is a common local anes compound, Such as through the use of a medication infusion thetic and antiarrhythmic drug and is often used topically to catheter. A typical example of such an existing infusion cath relieve itching, burning and pain from skin inflammations, as eter directed toward Supra and Subfacial administration of a well as being injected as a dental anesthetic, and in minor local anesthetic or a narcotic is provided by the ON-QR Surgery. Lidocaine, the first amino amide type local anes Painball infusion catheter system developed and marketed by thetic, was first synthesized in 1943 and was first marketed in I-Flow Corporation of Lake Forest, Calif. (hereinafter, the On 1948. As an anesthesia, lidocaine alters depolarization in Q System). Other efforts attempt to treat post-operative pain neurons by blocking the fast voltage gated sodium (Na) with periodic administrations (injections) of local anesthetic channels in the cell membrane. With sufficient blockade, the compounds and/or the use of local and systemic analgesics. membrane of the presynaptic neuron will not depolarize and 0004. In post-operative patients, the choices of pain relief So fail to transmit an action potential, leading to its anesthetic medications are aimed only at treating the multiple sources of effects. the pain felt by most post-operative patients. This is not 0009 While conventional pain management systems as always effective. The trauma caused by a Surgical procedure described above may benefit from the sustained release of a can result in pain derived directly from the site of intervention local anesthetic, such systems fail to fully and efficiently and from the indirect involvement of the Surrounding tissue, address the pain associated with muscle splitting Surgical US 2010/0184685 A1 Jul. 22, 2010 intervention procedures in a post-operative patient or in those been some more recent use of BTX-A for the treatment of patients who have refractory painto current treatments to help spasticity and muscle pain disorders, with approvals pending alleviate pain. A more complete combination of pain treat in many European countries and studies on headaches (in ment compounds, administered in an effective