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US 2002006 1835A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2002/0061835A1 Kensey (43) Pub. Date: May 23, 2002 (54) IN VIVO DELIVERY METHODS AND which is a continuation-in-part of application No. COMPOSITIONS 08/919,906, filed on Aug. 28, 1997, now patented. (76) Inventor: Kenneth R. Kensey, Malvern, PA (US) Publication Classification Correspondence Address: (51) Int. Cl. ............................. A61K 31/00; A61 B 5/00 CAESAR, RIVISE, BERNSTEIN, (52) U.S. Cl. ................................................. 514/1; 600/309 COHEN & POKOTILOW, LTD. 12TH FLOOR, SEVEN PENN CENTER (57) ABSTRACT 1635 MARKET STREET Various methods are provided for determining and utilizing PHILADELPHIA, PA 19103-2212 (US) the Viscosity of the circulating blood of a living being over Appl. No.: 09/828,761 a range of Shear rates for diagnostics and treatment, Such as (21) detecting/reducing blood Viscosity, work of the heart, con (22) Filed: Apr. 9, 2001 tractility of the heart, for detecting/reducing the Surface tension of the blood, for detecting plasma Viscosity, for Related U.S. Application Data explaining/countering endothelial cell dysfunction, for pro Viding high and low blood vessel wall Shear StreSS data, red (63) Continuation-in-part of application No. 09/727,950, blood cell deformability data, lubricity of blood, and for filed on Dec. 1, 2000, which is a continuation-in-part treating different ailments Such as peripheral arterial disease of application No. 09/628,401, filed on Aug. 1, 2000, in combination with administering to a living being at least which is a continuation-in-part of application No. one pharmaceutically acceptable agent. Agents pharmaceu 09/501856, filed on Feb. 10, 2000, now patented, tically effective to regulate at least one of the aforemen which is a continuation-in-part of application No. tioned blood parameters are used to adjust distribution of a 09/439,795, filed on Nov. 12, 1999, now patented, Substance through the bloodstream. PATENTS CIRCULATING HEMATOCR BLOOD ANAYER CRCULATING Remote Computers/Storage BOO) CONVEYING Poffer -38 PASMA MEANS, Printer -36 WISCOSY e.g. needle, ANAYZER in-dwelling catheier OherOther Computer(s) -3. ec. Dataloger S-32 Wolve SURFACE TENSION ANAYZER 28 Mechonism Display RED BOOD CE DEFORM ABY ANAYZER Column Level Dectector :54 Column level Dectector if 24-7 Patent Application Publication May 23, 2002 Sheet 1 of 19 US 2002/0061835 A1 PATIENTS CIRCULATING -30 44 HEMATOCRT BOOD t ANALYZER Other On-Line Services A2 -40 CIRCULATING Remote Computers/Storage BOOD CONVEYING 38 4 PASMA MEANS, VISCOSTY e.g. needle, Printer r-36 ANAYZER in-dwelling cathefer Other Computer(s) 34 : efc. 32 7OO 2O SURFACE B Battery TENSION B2 ANAYZER Valve 28 58 Mechanism Displuy Processor REPE OD Environmental DEFORM- Control Unit ABILITY 8O ANAYZER Capillary Bar Code 52 Reader 78 6OO Column Level Declector Declector if Patent Application Publication May 23, 2002 Sheet 2 of 19 US 2002/0061835 A1 F/G/A COLUMN COUMN LEVEL LEVEL DETECTOR DETECTOR | Range of h(t) DECREASING LEVEL TOWARD he . R2 : 82 : rage EEErd ho : h2(i) h9(i) - a m - - - - :---------- hit . 84 & VALVE -</ 3 MECHANISM E. TO CRCULATING BLOOD CONVEYING MEANS Patent Application Publication May 23, 2002 Sheet 3 of 19 US 2002/0061835 A1 PATIENTS A/G.2 CIRCULATING -3O HEMATOCRT BLOOD -/ 44 ANAYZER - - - - - - - - - - - m adapt or aw 26 Other On-Line Services 42 - 40 CIRCULATING Remote Computers/Storage BLOOD CONVEYING 38 PASMA ois Printer -36 VISCOSTY in-dwelling cathefer. Other Computer(s) 34 ANALYZER etc. Dataloger-32 700 20 -- - - - - - - - - - - - - - - - SURFACE B7- Battery TENSION ANALYZER B2- Ballery 2 - O3 58 Valve Wocutainer RED BLOOD Mechanism D Mechanism Column CE level DEFORM- - - - - - - - - - - - - - - - - Defector ABILITY # ANALYZER Riser Riser clip 6 OO Tubet - - - - TubeE. - - - - - - - - Defectoreve R R2 #2 52 Display Capillary 80 Environmental Control Unif Bar Code 78 Redder 22 24 Patent Application Publication May 23, 2002 Sheet 4 of 19 US 2002/0061835 A1 CIRCULATING BLOOD CONVEYING MEANS i vacutanerDRIVER i WALVE '- MECHANISM Warrrm : w vacutant COLUMN LEVEL DETECTOR range of h (i) 56 DECREASING LEVEL TOWARD he - INCREASING range LEVEL TOWARD he Of h2(i) aw -- or wrots were area as | -- " . COLUMN LEVEL &A t DETECTOR 54 \š3---it-33s Patent Application Publication May 23, 2002 Sheet S of 19 US 2002/0061835 A1 c. Eac A/G 3A OUTPUT (m/s) TIME CARDAC CYCLE -- eST -- PRESSURE P() A/G 3B SYSTOIC DASOLC TIME DASTOLE BLOOD VISCOSITY SYSTOE A/G. 3C l TIME Patent Application Publication May 23, 2002 Sheet 6 of 19 US 2002/0061835 A1 PRESSURE TIME PRESSURE P(t) fist O TIME Patent Application Publication May 23, 2002 Sheet 7 of 19 US 2002/0061835 A1 LCT 2. LC2 TBLOODFLOW T BLOOD FLOW 264 266 266 SS267 268SSS. 268 A/G.6A A/G.6EB 3OO / // \\ 305 yyyyyxxxx xxxxYxxxxYYYYava Patent Application Publication May 23, 2002 Sheet 8 of 19 US 2002/0061835 A1 A/G 7 Patent Application Publication May 23, 2002. Sheet 9 of 19 US 2002/0061835 A1 7OO 47 O COMPRESSED (INERT) GAS Patent Application Publication May 23, 2002 Sheet 10 of 19 US 2002/0061835 A1 A/G/O HEIGHT (h) SHEAR RATE = is Patent Application Publication May 23, 2002 Sheet 11 of 19 US 2002/0061835 A1 3.Lf1TOS87'SALOB-|-||3.HAILISOOSIAA Patent Application Publication May 23, 2002 Sheet 12 of 19 US 2002/0061835 A1 log EFFECTIVE BLOOD VISCOSITY I (u) A/G./24 ABSOLUTE log SHEAR RATE (s) log BOOD VISCOSY () A/G./2B log BLOOD VISCOSITY (CENTIPOSE) A/G/2C LOWSHEAR HIGH SHEAR (l) (150) log SHEAR RATE (s") Patent Application Publication May 23, 2002 Sheet 13 of 19 US 2002/0061835 A1 CJOO78Bº?nSSE?!dESTndEA?!nOLITILOVNINOO-gNyAJg +— LLEOONIy3435IS CJOOT8LISOOSIA„V LL39SÐNIMEXOIHIL BWOW)(SnO2SIA Patent Application Publication May 23, 2002. Sheet 14 of 19 US 2002/0061835 A1 F/G/4A LIGHT SOURCE LIGHT DETECTOR 8 TO A/G/4B Patent Application Publication May 23, 2002 Sheet 15 of 19 US 2002/0061835A1 GRAY SCALE WALUE 256 X. (POSITION) A/G/4C Patent Application Publication May 23, 2002 Sheet 16 of 19 US 2002/0061835 A1 REDNESS COLOR DETECTOR 606 6O2 F/G/64 A/G/6B Patent Application Publication May 23, 2002 Sheet 17 of 19 US 2002/0061835 A1 II LLI 9 T |---- OO 50 5 0. O.OO SHEAR RATE (s) Patent Application Publication May 23, 2002 Sheet 18 of 19 US 2002/0061835 A1 V VI PATIENT visitalso I S.S. A/G/8A log SHEAR RATE (s) V. PATIENT log IV-N WI B III BLOOD I A/G/3B VISCOSTY (u) log SHEAR RATE (s") log BLOOD VISCOSITY A/G/9 (u) N EXTREME LOW log SHEAR RATE (s") EXTREME HIGH SHEAR RATE S.HEAR RATE Patent Application Publication May 23, 2002 Sheet 19 of 19 US 2002/0061835 A1 A/G.2O REDUCE WORK DIRECT BENEFIT OF HEART MECHANICAL HOW: REDUCE BLOOD VISCOSITY WBRATION BLOOD THINNING MONITORING WITH DRUGS VISCOMETER 20/20 HOW BLOOD LETTING INJECTION OF DISTILLED WATER RED BLOOD CELL LOWSHEAR AGGOMERATION INJURY SURFACE TENSION OF WHOLE BLOOD A/G.2/ BLOOD LET ING DRUGS O ALTER SURFACE TENSION O O O O CO CD O ---as-s-s MOVING AT HIGH SPEED HIGH SHEAR STATE ROULEAUX FORMATION N FIG.22 - US 2002/0061835 A1 May 23, 2002 IN VIVO DELIVERY METHODS AND 138(4):705-709, 1999, discusses the use of the Goldman COMPOSITIONS algorithm for providing an indicator to acute myocardial infarction. The Goldman algorithm basically utilizes facts BACKGROUND OF THE INVENTION from a patient's history, physical examination and admission (emergency room) electrocardiogram to provide an AMI 0001. This invention relates generally to apparatus and indicator. methods for determining and utilizing the Viscosity of the 0005. In addition, there are a number of patents relating circulating blood of a living being for diagnostics and to blood Viscosity measuring apparatus and methods. See for treatment, and more particularly, apparatus and methods for example, U.S. Pat. No. 3,342,063 (Smythe et al.); U.S. Pat. detecting/reducing blood Viscosity, work of the heart, con No. 3,720,097 (Kron); U.S. Pat. No. 3,999,538 (Philpot, Jr.); tractility of the heart, for detecting/reducing the Surface U.S. Pat. No. 4,083,363 (Philpot); U.S. Pat. No. 4,149,405 tension of the blood, for detecting plasma Viscosity, for (Ringrose); U.S. Pat. No. 4,165,632 (Weber, et al.); U.S. explaining/countering endothelial cell dysfunction, for pro Pat. No. 4,517,830 (Gunn, deceased, et. al.); U.S. Pat. No. Viding high and low blood vessel wall Shear StreSS data, red 4,519,239 (Kiesewetter, et. al.); U.S. Pat. No. 4,554,821 blood cell deformability, lubricity of blood, and for treating (Kiesewetter, et. al.); U.S. Pat. No. 4,858,127 (Kron, et. al.); different ailments, Such as peripheral arterial disease. U.S. Pat. No. 4,884,577 (Merrill); U.S. Pat. No. 4947,678 0002 The importance of determining the viscosity of (Horietal); U.S. Pat. No. 5,181,415 (ESvanet al.); U.S. Pat. blood is well-known. Fibrogen, Viscosity and White Blood No. 5,257.529 (Taniguchi et al.); U.S. Pat. No. 5,271,398 Cell Count Are Major Risk Factors for Ischemic Heart (Schlain et al.); and U.S. Pat. No. 5,447,440 (Davis, et. al.). Disease, by Yarnell et al., Circulation, Vol. 83, No. 3, March 0006 The Smythe 063 patent discloses an apparatus for 1991; Postprandial Changes in Plasma and Serum Viscosity measuring the Viscosity of a blood Sample based on the and Plasma Lipids and Lipoproteins After an Acute Test preSSure detected in a conduit containing the blood Sample.
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    WHO DRUG INFORMATION VOLUME 4 • NUMBER 4 • 1990 PROPOSED INN LIST 64 INTERNATIONAL NONPROPRIETARY NAMES FOR PHARMACEUTICAL SUBSTANCES WORLD HEALTH ORGANIZATION • GENEVA WHO Drug Information WHO Drug Information provides an cerned with the rational use of overview of topics relating to drug drugs. In effect, the journal seeks development and regulation that to relate regulatory activity to are of current relevance and im­ therapeutic practice. It also aims to portance, and will include the lists provide an open forum for debate. of proposed and recommended In­ Invited contributions will portray a ternational Nonproprietary Names variety of viewpoints on matters of for Pharmaceutical Substances general policy with the aim of (INN). Its contents reflect, but do stimulating discussion not only in not present, WHO policies and ac­ these columns but wherever rel­ tivities and they embrace socio­ evant decisions on this subject economic as well as technical mat­ have to be taken. ters. WHO Drug Information is pub­ The objective is to bring issues that lished 4 times a year in English are of primary concern to drug and French. regulators and pharmaceutical manufacturers to the attention of a Annual subscription: Sw.fr. 50.— wide audience of health profes­ Airmail rate: Sw.fr. 60.— sionals and policy-makers con­ Price per copy: Sw.fr. 15.— © World Health Organization 1990 Authors alone are responsible for views expressed Publications of the World Health Organization in signed contributions. enjoy copyright protection in accordance with the provisions of Protocol 2 of the Universal The mention of specific companies or of certain Copyright Convention. For rights of reproduc­ manufacturers' products does not imply that they are tion or translation, in part or in toto, applica­ endorsed or recommended by the World Health tion should be made to: Chief, Office of Organization in preference to others of a similar na­ Publications, World Health Organization, ture which are not mentioned.
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    The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances FORMER DOCUMENT NUMBER: WHO/PHARM S/NOM 15 WHO/EMP/RHT/TSN/2018.1 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances. Geneva: World Health Organization; 2018 (WHO/EMP/RHT/TSN/2018.1). Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data.
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