(12) United States Patent (10) Patent No.: US 8,092.426 B2 Molnar (45) Date of Patent: *Jan
Total Page:16
File Type:pdf, Size:1020Kb
USOO8092426B2 (12) United States Patent (10) Patent No.: US 8,092.426 B2 Molnar (45) Date of Patent: *Jan. 10, 2012 (54) REGIONAL ANESTHESIA SYSTEMAND 5,647,373 A 7, 1997 Paltieli CART 5,700,147 A 12, 1997 Mills et al. 5,810,765 A 9, 1998 Oda 5,830,151 A 11/1998 HaZdic et al. (76) Inventor: James M. Molnar, Wyoming, OH (US) 6,022,337 A 2/2000 Herbst et al. - 6,055.458. A 4/2000 Cochran et al. (*) Notice: Subject to any disclaimer, the term of this 6,113,574 A 9/2000 Spinello patent is extended or adjusted under 35 6,179,829 B1 1/2001 Bisch et al. U.S.C. 154(b) by 0 days. 6,200,289 B1 3/2001 Hochman et al. This patent is Subject to a terminal dis- (Continued)Continued claimer. OTHER PUBLICATIONS (21) Appl. No.: 12/896,405 PCT International Search Report and Written Opinion for PCT/ US2009/042292 dated Dec. 16, 2009 (10 pages). (22) Filed: Oct. 1, 2010 (Continued) (65) Prior Publication Data Primary Examiner — Jackie Ho US 2011 FOO219 12 A1 Jan. 27, 2011 Assistant Examiner — Leah Stohr O O (74) Attorney, Agent, or Firm — Hasse & Nesbitt LLC; Related U.S. Application Data Ronald J. Richter; Donald E. Hasse (63) Continuation-in-part of application No. 12/114,634. filed on May 2, 2008, now Pat. No. 7,806,862. (57) ABSTRACT A regional anesthesia system and a cart for aiding in the (51) Int. Cl. placement of a regional anesthesia block without the need of A6M5/00 (2006.01) ancillary assistance. The invention includes equipment for A6M I/00 (2006.01) use in the performance of a regional anesthesia block which is (52) U.S. Cl. ......... 604/116; 604/118; 604/151: 600/439 carried on a cart for transporting and providing a stable foun (58) Field of Classification Search .................... 604/30, dation for the equipment. The equipment includes a nerve 604/116, 118, 151-153, 181, 182; 600/439, localization means such as ultrasound or a peripheral nerve 600554;606/130,439 stimulator for locating a target nerve of a patient, a position See application file for complete search history. assist arm for maintaining the position of the localization means over the target nerve while the operator inserts an (56) References Cited anesthetic needle over the target nerve, and an anesthetic infusion device for infusing or aspirating through the anes U.S. PATENT DOCUMENTS thesia needle. The infusion device includes an infusion pump 4,756,706 A 7, 1988 Kerns et al. controlled by a foot pedal. The system may be easily trans 5,053,002 A 10, 1991 Barlow ported to a patient requiring a regional anesthesia block, and 5, 180,371 A 1/1993 Spinello 5,234.406 A 8, 1993 Drasner et al. allows the regional anesthesia block to be performed with 5,268,624 A 12/1993 Zanger minimal ancillary assistance. 5,472.416 A 12/1995 Blugerman et al. 5,580,347 A 12/1996 Reimels 16 Claims, 4 Drawing Sheets US 8,092.426 B2 Page 2 U.S. PATENT DOCUMENTS 6,942,637 B2 9/2005 Cartledge et al. 6,945,954 B2 9, 2005 Hochman et al. R 383 sian 6,962.581 B2 11/2005 Thoe law aCa 6,966,899 B2 11/2005 Hochman et al. 6,428,517 B1 8/2002 Hochman et al. 7,022,082 B2 4, 2006 Sonek is: R 29: SR 7,311,691 B2 12/2007 Cartledge et al. 6530928 B13. 3/2003 R U 604/30 2002fOO 13640 A1 1/2002 Phoon et al. 6653.482 B2 11/2003 FAn tal." 2002/00 16569 A1 2/2002 Critchlow et al. 6,663.202 B2 i3/2003 s a Ca. 2002/0096845 A1* 7/2002 Spann .......................... 280/79.2 ww- pann 2003.0167021 A1 9, 2003 Shimm 6,663,569 B1 12/2003 Wilkins et al. 6.676,669 B2 1/2004 Charles etal 2005/023694.0 A1 10, 2005 Rockoff 6,716,167 B1 4/2004 Henderson et al. 2007/0129634 A1* 6/2007 Hickey et al. ................. 600,439 6,726,658 B2 4/2004 Hochman OTHER PUBLICATIONS 6,786,885 B2 9/2004 Hochman et al. 6,807,965 B1 10/2004 Hickle PCT International Preliminary Report on Patentability for PCT/ 6,866,648 B2 3/2005 Hazdic et al. US2009/042292 dated Nov. 2, 2010 (4 pages). 6,887.216 B2 5, 2005 Hochman et al. 6,905,482 B2 6, 2005 Hochman * cited by examiner U.S. Patent Jan. 10, 2012 Sheet 1 of 4 US 8,092.426 B2 U.S. Patent Jan. 10, 2012 Sheet 2 of 4 US 8,092.426 B2 U.S. Patent Jan. 10, 2012 Sheet 3 of 4 US 8,092.426 B2 U.S. Patent Jan. 10, 2012 Sheet 4 of 4 US 8,092.426 B2 FG. 4 US 8,092,426 B2 1. 2 REGIONAL ANESTHESA SYSTEMAND Although uncommon, the risks of RA include nerve injury, CART permanent nerve damage, intravascular injection of local anesthetic resulting in Systemic toxicity, and pneumothorax CROSS REFERENCE TO RELATED (e.g. following Supraclavicular block). However, these risks APPLICATION can be minimized by proper localization of the target nerve and placement of the needle at the injection site, followed by This application is a continuation-in-part of application controlled infusion of the local anesthetic. Ser. No. 12/114,634, filed May 2, 2008 now U.S. Pat. No. While successful block of a target nerve typically depends 7,806,862. upon accurate placement of local anesthetic in Sufficient 10 amounts around the nerve, locating the target nerve has often FIELD OF THE INVENTION proved problematical in patients with difficult landmarks. Utilization of new technology, Such as evoking parathesias The present invention relates generally to devices and and using peripheral nerve stimulators (PNS) or ultrasound methods for performing regional anesthesia, and more par for localization, has typically been haphazard and can often 15 further complicate the process rather than simplify it. The ticularly to a regional anesthesia system and a cart for making techniques of evoking parathesias and peripheral nerve the system transportable. stimulation are essentially “blind procedures, since they rely on indirect evidence of needle-to-nerve contact. Seeking BACKGROUND OF THE INVENTION nerves by trial and error and random needle movement can cause complications. Therefore, proper peripheral nerve Regional anesthesia (RA) procedures and, in particular, stimulation for nerve localization, while holding promise for peripheral nerve blocks for Surgical anesthesia and postop improving block Success and decreasing complications, erative analgesia, are typically performed for pain relief dur requires clinical experience and should only be used by ing and after Surgical procedures. RA is typically used for trained individuals. Unfortunately, typically only one labor, chronic pain, in epidural, Subdural or spinal proce 25 “trained individual' is present for the placement of the nerve dures, and for plexus blocks and blocks of peripheral nerves block (i.e. an anesthesiologist, nurse anesthetist or other prac (e.g. axillary and interscalene blocks of the brachial plexus, titioner), and this individual only has two hands where often femoral nerve, Sciatic nerve and popliteal nerve blocks). many hands are required simultaneously. Peripheral nerve blocks, when properly performed, can be With the advent and introduction of ultrasound into clinical Superior to general anesthesia, as they can provide effective 30 practice of RA, these issues have only become more com analgesia with few side effects and can hasten patient recov pounded. Trying to position and prep the patient, use PNS or ery. an ultrasound probe to find the nerve, determine an injection RA is typically performed in a separate block-placement site close to the nerve, place the needle at the injection site, area or in the operating room. Typically the anesthesiologist and inject the medication while maintaining the needle posi or practitioner performing the block requires ancillary staff to 35 tion during injection can be very difficult to master without a assist in the procedure (e.g. localizing the nerve with an well-trained ancillary staff. However, increasing demands are ultrasound probe, holding an ultrasound probe in place over often placed upon regional anesthesia practitioners such that the nerve, holding and injecting the local anesthetic, etc.) extra personnel are not always available to assist the practi while the practitioner carefully inserts the needle and then tioner perform the procedures. Further, sometimes situations holds the needle in place at the injection site. Indeed, Success 40 occur where it would be beneficial if the procedure were ful block placement has often required the use of three, four or performed in a cramped space at the patient’s bedside, where more hands. Most practitioners require nurses to be present to only one individual has adequate access to the patient. There perform some of the duties. Such as pushing the local anes are also situations in which the practitioner must move thetic solution of choice through a syringe and needle placed quickly from one Surgical Suite to another in order to perform at the injection site, once the needle has been stabilized over 45 blocks on multiplepatients overa short period of time. In such the nerve of interest by the practitioner. This need for “another situations, it would be beneficial if the practitioner were able set of hands' can be a disadvantage, as “feel is important to to perform the needed RA procedures alone, or with minimal the practitioner for knowing if the needle is in the right place. ancillary assistance. It would also be helpful if the practitio Historically, due to comparatively unreliable Success rates ner had sufficient Supplies and equipment that were also able and often time-consuming block placement procedures, RA 50 to travel with him from one Surgical Suite to another.