Source: https://patents.justia.com/patent/10175225
Timestamp: 2019-10-20 11:56:09
Document Index: 127503367

Matched Legal Cases: ['art-12', 'Application No. 200980151858', 'Application No. 200980151858', 'Application No. 13167983', 'Application No. 08172769', 'Application No. 12179576', 'Application No. 13167979', 'Application No. 2011', 'Application No. 2014', 'Application No. 1020117017187', 'Application No. 1020167029191', 'Application No. 2015']

US Patent for Blood testing system and method Patent (Patent # 10,175,225 issued January 8, 2019) - Justia Patents Search
Justia Patents US Patent for Blood testing system and method Patent (Patent # 10,175,225)
Sep 29, 2014 - C A Casyso AG
Latest C A Casyso AG Patents:
Method for measuring coagulation of blood samples using viscoelastic tests (VET)
Particular embodiments described herein include a cartridge for use with a blood testing console. The cartridge may include a blood sample receiver configured to receive a blood sample to be tested. The cartridge may also include one or more blood processing and testing paths. Each blood processing and testing path can receive a portion of the blood sample and may include a blood sample volume measurement chamber, a mixing chamber, and a viscoelastic blood testing chamber. The blood sample volume measurement chamber may be in fluid communication with the blood sample receiver, and the blood sample volume measurement chamber may a selected internal volume to contain a predefined volume of blood sample from the blood sample container. The mixing chamber may be in fluid communication with the blood sample volume measurement chamber and with a reagent, and the mixing chamber may be configured to receive blood sample from the blood sample volume measurement chamber and mix the received blood with the reagent. The viscoelastic blood testing chamber may be configured to receive mixed blood and reagent from the mixing chamber for a viscoelastic test to be performed on the mixed blood and reagent while the mixed blood and reagent resides in the testing chamber.
In some embodiments described herein, a cartridge device may include a blood sample receiver, and a plurality of blood sample pathways in selective fluid communication with the blood sample receiver. Each blood sample pathway may include: a blood measurement chamber to receive a predetermined amount of a blood sample via the blood sample receiver, a reagent mixing chamber for receiving and mixing the predetermined amount of the blood sample with one or more reagents, and a blood coagulation blood testing chamber for receiving from the reagent mixing chamber at least a portion of the blood sample with one or more reagents mixed therewith. Optionally, the blood coagulation blood testing chamber may have a movable probe therein for measuring blood coagulation characteristics.
Various embodiments described herein include a cartridge device for a measuring system for measuring viscoelastic characteristics of a blood sample. The cartridge may include a blood sample receiver; and at least one blood sample pathway in selective fluid communication with the blood sample receiver. The blood sample pathway may include: a blood measurement chamber configured to be filled with a predetermined amount of a blood sample via the blood sample receiver, a reagent mixing chamber for receiving the predetermined amount of the blood sample from the blood measurement chamber and for and mixing the predetermined amount of the blood sample with one or more reagents, and a blood coagulation blood testing chamber for receiving from the reagent mixing chamber at least a portion of the blood sample with one or more reagents mixed therewith, and an overflow chamber in fluid communication with the blood sample pathway so as to collect excess blood from the blood measurement chamber beyond the predetermined amount the blood sample. Optionally, the blood coagulation blood testing chamber may have a movable probe therein for measuring blood coagulation characteristics.
In some embodiments described herein, a cartridge device for a measuring system for measuring viscoelastic characteristics of a blood sample may include a plurality of blood testing chambers for measuring blood coagulation characteristics. Each of the blood testing chambers may be exposed to atmosphere and may have a blood input port positioned along a sidewall of the blood testing chamber. Optionally, each of the blood testing chambers is in fluid communication with an output port of a respective reagent mixing chamber that is defined in cartridge device at a height below the blood input port of the blood testing chamber.
In the depicted embodiment, the touchscreen display 142 is configured to receive user input and to display output information to the user. For example, the user can enter information to the thromboelastometry system 100 by making selections of various soft-buttons that may be displayed on the touchscreen display 142 at times during the beginning, middle, and end of the testing process. In some embodiments, other selections such as, but not limited to, soft keyboard entries can be provided via touchscreen display 142. In some embodiments, data entry can be performed additionally or alternatively by voice entry. In other embodiments, the user interface may include other peripheral devices can be included (e.g., a mouse, a keyboard, an additional display device, and the like) as part of the thromboelastometry system 100. In some embodiments, a computer data network (e.g., intranet, interact, LAN, etc.) may be used to allow for remote devices to receive and/or input information from the system 100. For example, in some embodiments one or more remote displays can be utilized via network connections. In the depicted embodiment, the thromboelastometry system 100 also includes an external barcode reader 146. The external barcode reader 146 can facilitate convenient one-dimensional or two-dimensional barcode entry of data such as, but not limited to, blood sample data, user identification, patient identification, normal values, and the like. Alternatively or additionally, the thromboelastometry system 100 can be equipped with a reader configured to read near-field communication tags, RFID tags, or the like.
In some embodiments, overmolding, such as by insert molding or multi-shot molding techniques, may be used to construct some aspects of the main body 124, right cover 126, and/or left cover 128. For example, elastomeric valve elements (as described further below) may be overmolded in the left cover 128. Further, in some embodiments secondary operations may be performed to the cartridge 120. For example, one or more needles 123a-b (refer to FIG. 6) for piercing a blood collection tube may be installed within the sample well 122 using secondary operations.
The single-use cartridge 120 also includes the five pins 138a, 138b, 138c, 138d, and 138e. The pins 138a-e are individual component parts (e.g., refer to FIG. 10B) that are retained within openings of the main body 124 (e.g., within testing chambers 136a-e (sometimes referred to as “cups”) as described further below in connection with FIGS. 8A-10B). Tabs 129, located on the right and left covers 126 and 128, mechanically retain the pins 138a-e in the main body 124. However, the pins 138a-e are free to move within the confines of the main body 124 to a limited extent. For example, the pins 139a-e are free to rotate uninhibitedly within the main body 124 and to translate vertically by few millimeters. This configuration of the pins 138a-e in relation to the other components of the cartridge 120 can be created as follows. Prior to affixing the right and left covers 126 and 128 to the main body 124, the pins 138a-e can be placed within their respective locations in the main body 124 as shown in FIG. 5. With the pins 138a-e positioned in the main body 124, the right and left covers 126 and 128 can then be affixed to the main body 124. In another example, the right and left covers 126 and 128 are affixed to the main body 124 and thereafter the pins 138a-e are pushed into the main body 122 past the tabs 129. The tabs 129 of the right and left covers 126 and 128 will block the pins 138a-e from falling out of the main body 122, even if the cartridge 120 is turned upside down.
The outlet ports are located at the bottom of the measuring chambers. For example, measuring chamber outlet port 132ao is located at the bottom of the measuring chamber 132a. This configuration can help facilitate the complete filling of the measuring chambers 132a-e with blood. As such, a precise volume of blood is contained within the measuring chambers 132a-e.
Referring now to FIGS. 6 and 7, additional features of the cartridge 120 will now be described. In FIG. 6, a side view of particular chambers of the cartridge 120 (measuring chambers 132a-e, reagent mixing chambers 134a-e, and blood coagulation testing chambers 136a-e) is provided. In FIG. 7, a left side view of cartridge 120 and individual channels 130a-e is provided. In this view there is visibility of testing chamber inlet ports 136ai, 136bi, 136ci, 136di, and 136ei for testing chambers 136a-e respectively. The inlet ports 136ai-ei are located near the top of the testing chambers 136a-e, for example, along a side wall of the chamber 136a-e and at a height above the distal head of the pin 138a-e that interacts with the blood sample but below the proximal end of the pin 138a-e (refer to FIG. 10B). This configuration can be advantageous if the blood contains gaseous bubbles, because such gas may be allowed to escape from the blood as the blood enters the cups 136a-e. In addition, this configuration may advantageously minimize fluid flow turbulence as the blood flows into the testing chambers 136a-e.
Referring to FIG. 6 in more detail, some embodiments of the mixing chambers 134a-e contain: (i) one or more dissolvable reagent beads 180, (ii) multiple retaining elements 182, and (iii) a mixing element 184. The one or more reagent beads 180 are disposed within and retained within the confines of the multiple retaining elements 182. The mixing elements 184 are disposed in the bottom portions of the mixing chambers 134a-e, and are free to move horizontally across the bottom portions of the mixing chambers 134a-e. The multiple retaining elements 182 separate the reagent beads 180 from the mixing element 184, and prevent the mixing element 184 from migrating upward away from the bottom portions of the mixing chambers 134a-e. Preferably, the retaining elements 182 extend into each mixing chamber 134a-e so as to maintain a predetermined vertical position of each of the reagent beads 180 within the mixing chamber (e.g., a vertical position below the height of the blood portion passed into the mixing chamber 134a-e), thereby ensuring that each of the beads 180 will be submerged when the predetermined amount of blood is directed into the respective mixing chamber 134a-e. Also, in some embodiments, the multiple retaining elements 182 in each mixing chamber 134a-e maintain each of the reagent beads 180 in the respective mixing chamber 134a-e separate from one another. In such embodiments, each of the reagent beads 180 is not contacted by other beads 180 in the respective mixing chamber 134a-e, is not contacted by the mixing element 184 in the respective mixing chamber 134a-e, and is maintained at a vertical height within the respective mixing chamber 134a-e below the height of the blood portion transported into the respective mixing chamber 134a-e.
In the depicted embodiment, the one or more dissolvable reagent beads 180 are spherical and are of two different sizes (e.g., about 2 mm diameter and about 3 mm diameter). However, the use of other shapes and/or sizes of reagent beads 180 is also envisioned. In some embodiments, the reagent beads 180 are lyophilized materials, but other forms of materials are also envisioned. The reagent beads 180 can comprise materials such as, but not limited to, CaCl2, ellagic acid/phospholipids, tissue factor, heparinase, polybrene, cytochalasin D, tranexamic acid, and the like, and combinations thereof. The reagent beads 180 are dissolvable in blood. For example, in this particular embodiment, each of the five mixing chambers 134a-e is configured to mix a predetermined volume of blood (as defined by the respective measurement chamber 132a-e) with a different reagent composition (from the one or more reagent beads 180 therein) for purposes of performing five different assays. In this example, the first mixing chamber 134e may include multiple reagent beads 180 the provide CaCl2 and ellagic acid/phospholipids for mixing with the predefined volume of blood (from the corresponding measuring chamber 132e) so that the first sample portion can be used in a first type of assay. Also in this example, the second mixing chamber 134d may include multiple reagent beads 180 the provide CaCl2, ellagic acid/phospholipids, and heparinase for mixing with the predefined volume of blood (from the corresponding measuring chamber 132d) so that the second sample portion can be used in a second type of assay. Further, in this example, the third mixing chamber 134c may include multiple reagent beads 180 the provide CaCl2, tissue factor, and polybrene for mixing with the predefined volume of blood (from the corresponding measuring chamber 132c) so that the third sample portion can be used in a third type of assay. Also in this example, the fourth mixing chamber 134b may include multiple reagent beads 180 the provide CaCl2, tissue factor, polybrene, and cytochalasin D for mixing with the predefined volume of blood (from the corresponding measuring chamber 132b) so that the fourth sample portion can be used in a fourth type of assay. Lastly, in this example, the fifth mixing chamber 134a may include multiple reagent beads 180 the provide CaCl2, tissue factor, polybrene, and tranexamic acid for mixing with the predefined volume of blood (from the corresponding measuring chamber 132a) so that the fifth sample portion can be used in a fifth type of assay.
While the example fluidic control process 200 includes five blood flow channels (each comprising a measuring chamber 132a-e, a mixing chamber 134a-e, and a cup 136a-e respectively), it should be understood that having five blood flow channels is not required in all embodiments. For example, in some embodiments only a single blood flow channel is included. Alternately, two blood flow channels are included, or three blood flow channels are included, or four blood flow channels are included, or six blood flow channels are included, or more than six blood flow channels are included.
Referring to FIG. 8B, the measuring chambers 132a-e are filled with blood, and a small amount of blood is contained within the overflow chamber 139. To arrive at this state, the following changes were made (in comparison to FIG. 8A) and/or the following conditions existed: (i) the valves 168 and 170 were opened, (ii) the valves 160a-e were closed, (iii) the vents 166a-e were closed, (iv) a negative pressure was applied to the vacuum application port 162, and (v) the pressure application port 164 was unpressurized. Accordingly, the blood flowed: (i) out of the blood collection tube 10, (ii) through the valve 168, (iii) through the blood detection location 127a, (iv) into and filling the measuring chamber 132a, (v) into and filling the measuring chamber 132b, (vi) into and filling the measuring chamber 132c, (vii) into and filling the measuring chamber 132d, (viii) into and filling the measuring chamber 132e, (ix) through blood detection location 127b, (x) through valve 170, and (xi) into the overflow chamber 139. When blood was detected in the blood detection location 127b, the application of the negative pressure was discontinued—thereby stopping further blood flow.
Referring to FIG. 8E, the measuring chambers 132a-c are still filled with blood, the cup 136e is still filled with blood/reagent mixture, and the blood that was in the measuring chamber 132d (refer to FIG. 8D) has transferred to the mixing chamber 134d. To arrive at this state, the following changes were made (in comparison to FIG. 8D) and/or the following conditions existed: (i) the valves 168 and 170 remained closed, (ii) the valve 160e was closed, (iii) the valves 160a-d remained closed, (iv) the vent 166d was opened (v) the vents 166a-c and 166e remained closed, and (vi) a source of air pressure was applied to the pressure application port 164. Accordingly, the blood flowed: (i) out of the measuring chamber 132d, and (ii) into the mixing chamber 134d. Because the vents 166a-c and because the valves 160a-c remained closed, the blood did not flow from the measuring chambers 132a-c towards the mixing chambers 134a-c. With blood in the mixing chamber 134d, the mixing element in mixing chamber 134d can agitate the blood to facilitate the dissolving of the reagent beads therein.
Referring to FIG. 8G, the measuring chambers 132a-b are still filled with blood, the cups 136d-e are still filled with blood/reagent mixture, and the blood that was in the measuring chamber 132c (refer to FIG. 8F) has transferred to the mixing chamber 134c. To arrive at this state, the following changes were made (in comparison to FIG. 8F) and/or the following conditions existed: (i) the valves 168 and 170 remained closed, (ii) the valve 160d was closed, (iii) the valves 160a-c and 160e remained closed, (iv) the vent 166c was opened (iv) the vents 166a-b and 166d-e remained closed, and (v) a source of air pressure was applied to the pressure application port 164. Accordingly, the blood flowed: (i) out of the measuring chamber 132c, and (ii) into the mixing chamber 134c. Because the vents 166a-b and because the valves 160a-b remained closed, the blood did not flow from the measuring chambers 132a-b towards the mixing chambers 134a-b. With blood in the mixing chamber 134c, the mixing element in mixing chamber 134c can agitate the blood to facilitate the dissolving of the reagent beads therein.
The cup 136b and pin 138b are shown in cross-section in FIG. 10B (in accordance with section 10B-10B of FIG. 10A). In addition, a blood inlet port 136bi (located behind pin 138b in the orientation of FIG. 10B) is provided so that the blood/reagent mixture will flow into the cup 136b via the blood inlet port 136bi. In the depicted embodiment, the cup inlet port 136bi is located in a sidewall of cup 136b at a height above the widened distal portion (refer to shoulder 138bs) of the pin 138b but below the proximal end of the pin 138b (refer to end near the entry to the axial bore 138bb of the pin 138b). In this configuration, the blood/reagent mixture will flow into the cup 136b so as to reduce the potential for bubble formation. In addition, locating the cup inlet port 136bi near the top of cup 136b eliminates the effects that the cup inlet port 136bi may otherwise have on the thromboelastometry measurements performed in the cup 136b if the cup inlet port 136bi is located in the active space between the inner diameter of the cup 136b and the outer diameter of the pin 138b below the shoulder 138bs.
The moveable block sub-assembly can include multiple solenoids that are used to actuate the aforementioned vents and valves of the cartridge 120. For example (referring also to FIG. 7), the valves 168, 170, and 160 a-e, can be actuated by valve actuators 430 and the vents 166a-e can be actuated by vent actuators 432. In some embodiments, the valve actuators 430 and the vent actuators 432 comprise solenoids. Actuation of the valves 168, 170, and 160 a-e by the valve actuators 430 can be accomplished by coupling pins to the valve actuators 430 that are extendable from the moveable block sub-assembly to make contact with and to distend valve elastomer members so that the elastomer members make contact with a valve seat within the cartridge 120. Actuation of the vents 166a-e by the vent actuators 432 can be accomplished by coupling pins with resilient tips that are extendable from the moveable block sub-assembly to obstruct the vents 166 a-e. Such pins with resilient tips can act as stoppers to substantially prevent airflow through the vents 166a-e. In some embodiments, the valve actuators 430 and the vent actuators 432 comprise solenoids that include internal springs that cause the valve actuators 430 and the vent actuators 432 to be normally extended (e.g., when the electrical power is removed from the solenoids). Accordingly, such normally closed solenoids will close the vents and valves of the cartridge 120 as a default configuration.
1. A cartridge for use with a blood testing console, the cartridge comprising:
a blood sample receiver configured to receive a blood sample to be tested;
and a plurality of blood processing and testing paths arranged in a parallel, each blood processing and testing path receiving a portion of the blood sample, and each blood processing and testing path comprising:
a blood sample volume measurement chamber in fluid communication with the blood sample receiver, the blood sample volume measurement chamber having a selected internal volume to contain a predefined volume of blood sample from the blood sample container;
a mixing chamber in fluid communication with the blood sample volume measurement chamber and with a reagent, the mixing chamber configured to receive the predetermined volume of the blood sample from the blood sample volume measurement chamber and mix the received blood with the reagent; and
a viscoelastic blood testing chamber configured to receive mixed blood and reagent from the mixing chamber for a viscoelastic test to be performed on the mixed blood and reagent while the mixed blood and reagent resides in the testing chamber.
2. The cartridge of claim 1, wherein the blood sample volume measurement chamber of the blood processing and testing paths are arranged in a series such that a first blood sample volume measurement chamber of a first one of the blood processing and testing paths is configured to be filled with blood sample to a predefined level, a second blood sample volume measurement chamber of a second one of the blood processing and testing paths configured to be filled with blood overflowing the first blood sample volume measurement chamber, and thereafter each successive blood sample volume measurement chamber is configured to be filled in series with blood overflowing from the previous blood sample volume measurement chamber.
3. The cartridge of claim 2, further comprising a vacuum port at an opposite end of the series of the blood sample volume measurement chambers from the blood sample receiver, wherein the cartridge is configured such that, when an external vacuum is applied to the vacuum port, blood is transported from the blood sample receiver to fill each of the blood sample volume measurement chambers in series.
4. The cartridge of claim 3, further comprising a first conduit for transporting blood between the blood sample receiver and the blood sample volume measurement chamber of a first one of the blood processing and testing paths.
5. The cartridge of claim 4, further comprising a first valve positioned in the first conduit, the first valve being configured to be selectively opened to allow blood sample to be transported through the first conduit from the blood sample receiver to fill each of the blood sample volume measurement chambers in series.
6. The cartridge of claim 1, wherein each of the blood processing and testing paths comprises a second conduit for transporting blood between the blood sample volume measurement chamber and the corresponding mixing chamber.
7. The cartridge of claim 5, wherein each of the blood processing and testing paths comprises a first vent to ambient outside of the cartridge, each first vent being positioned such that blood does not flow through the second conduit from the blood sample volume measurement chamber to the mixing chamber when the first vent is in a closed position.
8. The cartridge of claim 6, wherein the first vent is configured to be selectively opened, and wherein the cartridge is configured such that blood flows from the blood sample measurement chamber to the mixing chamber when the first vent is in an open position.
9. The cartridge of claim 1, wherein the mixing chamber comprises reagent beads in solid form that dissolves when contacted with the blood from the blood sample volume measurement chamber to provide the mixed blood and reagent in the mixing chamber, and wherein the reagent beads comprise reagent compositions including one or more of CaCl2, ellagic acid/phospholipids, tissue factor, heparinase, polybrene, cytochalasin D, tranexamic acid.
10. The cartridge of claim 1, wherein each of the blood processing and testing paths comprises a third conduit for transporting the mixed blood and reagent from the mixing chamber to the corresponding viscoelastic blood testing chamber.
11. The cartridge of claim 10, wherein each of the blood processing and testing paths comprises a second valve positioned in the third conduit, each second valve being configured to prevent the flow of the mixed blood and reagent through the third conduit when in a closed position and to allow the flow of the mixed blood and reagent through the third conduit when in an open position.
12. The cartridge of claim 11, further comprising a pressure application port positioned such that, when an outside pressure is applied to the pressure application port and the second valve is in an open position, the mixed blood and reagent from the mixing chamber is transported through the third conduit from the mixing chamber to the corresponding viscoelastic blood testing chamber.
13. The cartridge of claim 1, wherein the viscoelastic blood testing chamber comprises a movable probe element therein that mechanically tests for blood coagulation characteristics.
2555937 June 1951 Rosenthal
2995425 August 1961 Hans
3714815 February 1973 Hartert et al.
3803903 April 1974 Lin
3903903 September 1975 Matsumura
4148216 April 10, 1979 Do et al.
4193293 March 18, 1980 Cavallari
D260428 August 25, 1981 Fekete
4319194 March 9, 1982 Cardinal
4599219 July 8, 1986 Cooper
4726220 February 23, 1988 Feier et al.
4765180 August 23, 1988 Clifton
D305360 January 2, 1990 Fechtner
5009316 April 23, 1991 Klein
D327743 July 7, 1992 Frenkel
5222808 June 29, 1993 Sugarman et al.
5223227 June 29, 1993 Zuckerman
5287732 February 22, 1994 Sekiguchi
D347067 May 17, 1994 Shartle et al.
5531102 July 2, 1996 Brookfield et al.
5777212 July 7, 1998 Sekiguchi et al.
5777215 July 7, 1998 Calatzis et al.
5788928 August 4, 1998 Carey
6012712 January 11, 2000 Bernstein
6200532 March 13, 2001 Wu
6448024 September 10, 2002 Bruegger
6537819 March 25, 2003 Cohen
6613286 September 2, 2003 Braun et al.
D481133 October 21, 2003 Blouin
D482454 November 18, 2003 Gebrian
6662031 December 9, 2003 Khalil et al.
6699718 March 2, 2004 Bruegger
6750053 June 15, 2004 Opalsky
6942836 September 13, 2005 Freudenthal et al.
6951127 October 4, 2005 Bi
7399637 July 15, 2008 Wright et al.
7412877 August 19, 2008 Bi
7422905 September 9, 2008 Clague
7491175 February 17, 2009 Ruether et al.
7497997 March 3, 2009 Glezer et al.
7524670 April 28, 2009 Cohen
7595169 September 29, 2009 Swaim et al.
7732213 June 8, 2010 Cohen et al.
7745223 June 29, 2010 Schubert et al.
7811792 October 12, 2010 Cohen
7947505 May 24, 2011 Kawasaki et al.
D645973 September 27, 2011 Hoenes
8110392 February 7, 2012 Battrell et al.
8168442 May 1, 2012 Petersen et al.
8383045 February 26, 2013 Schubert et al.
8448499 May 28, 2013 Schubert et al.
8857244 October 14, 2014 Schubert et al.
D737993 September 1, 2015 Tan
9272280 March 1, 2016 Viola
9285377 March 15, 2016 Schubert
D777343 January 24, 2017 Gorin et al.
20020081741 June 27, 2002 Braun, Sr.
20030073244 April 17, 2003 Cohen et al.
20040131500 July 8, 2004 Chow
20050233466 October 20, 2005 Wright
20070059840 March 15, 2007 Cohen et al.
20080026476 January 31, 2008 Howell
20080160500 July 3, 2008 Fuller
20080227217 September 18, 2008 Yamamoto et al.
20080251383 October 16, 2008 Sobek
20080297169 December 4, 2008 Greenquist et al.
20090130645 May 21, 2009 Schubert et al.
20100154520 June 24, 2010 Schubert et al.
20100184201 July 22, 2010 Schubert et al.
20110237913 September 29, 2011 Schubert et al.
20120294767 November 22, 2012 Viola
20130323846 December 5, 2013 Schubert et al.
20130323847 December 5, 2013 Schubert et al.
20130323848 December 5, 2013 Schubert et al.
20130333448 December 19, 2013 Schubert et al.
20140004613 January 2, 2014 Goldstein
20140271409 September 18, 2014 Knight
20160091415 March 31, 2016 Gorin
20160091514 March 31, 2016 Gorin et al.
20160091515 March 31, 2016 Gorin et al.
20160091516 March 31, 2016 Gorin
20160091517 March 31, 2016 Gorin
20160195557 July 7, 2016 Schubert
20160313357 October 27, 2016 Viola
20160377638 December 29, 2016 Bels et al.
1853104 October 2006 CN
101195112 June 2008 CN
2740932 November 1978 DE
10135569 February 2003 DE
202014002289 September 2014 DE
0404456 December 1990 EP
1367392 December 2003 EP
1394546 March 2004 EP
1627725 February 2006 EP
1884778 February 2008 EP
1901065 March 2008 EP
2208996 September 2010 EP
2202517 August 2012 EP
2257256 January 1993 GB
1971-004947 November 1971 JP
1987-140047 June 1987 JP
1991-031764 February 1991 JP
1997-159596 June 1997 JP
09-507580 July 1997 JP
2001-516880 October 2001 JP
2006-053142 February 2006 JP
2010-266453 November 2010 JP
2011-174952 September 2011 JP
2012-513582 June 2012 JP
2012-515340 July 2012 JP
2015-045642 March 2015 JP
WO 1989/006803 July 1989 WO
WO 1999/014595 March 1999 WO
0250535 June 2002 WO
WO 2002/063273 August 2002 WO
WO 2005/106467 November 2005 WO
WO 2006/091650 August 2006 WO
WO 2006/126290 November 2006 WO
WO 2007/047961 April 2007 WO
WO2008075181 June 2008 WO
WO 2010072620 July 2010 WO
WO 2008/093216 August 2011 WO
WO 2011/117017 September 2011 WO
WO 2013/172003 November 2013 WO
2014103744 July 2014 WO
2014115478 July 2014 WO
Anonymous: “Rotem® delta Whole Block Haemostasis System using Thromboelastometry US Operating Manual,” [retrieved on Dec. 30, 2015]. Retrieved from the Internet: <URL:http://www.sfgh-poct.org/wp-content/uploads/2013/02/ROTEM-delta-US-Operating-Manual-Part-12.pdf>, 76 pages, Sep. 2012.
Lang et al., “Evaluation of the new device ROTEM platelet” [retrieved on Dec. 28, 2015]. Retrieved from the Internet: <URL: https://www.rotem.de/wp-content/uploads/2014/09/Lang-et-al-2014.pdf>, Jan. 1, 2014.
U.S. Appl. No. 29/528,390, filed May 28, 2015, Gorin et al.
U.S. Appl. No. 14/754,300, filed Jun. 29, 2015, Bets et al.
ROTEM® delta, “Targeted therapy stops the bleeding,” 6 pages, Jan. 6, 2014, [brochure].
ROTEM® delta, “Whole Blood Haemostasis System using Thromboelastomerty Operating Manual,” 164 pages, Nov. 17, 2014 [brochure].
“HealthPACT, ““Rotational thromboelastometry (ROTEM)—targeted therapy for coagulation management in patients with massive bleeding,””Heath PolicyAcivisory Committee on Technology. Retrieved from the Internet: <URL: https://www.health.qld.gov.au/healthpact/docs/briefs/WP024.pdf>, 30 pages, Nov. 2012”.
Chinese Office Action for Application No. 200980151858.5 dated May 21, 2013, 16 pages.
Chinese Office Action for Application No. 200980151858.5, dated Feb. 14, 2014, 4 pages.
European Extended Search Report for Application No. 13167983.9, dated Nov. 6, 2013, 3 pages.
European Office Action for Application No. 08172769.5, dated Jun. 1, 2011, 12 pages.
European Office Action for Application No. 12179576.9, dated May 22, 2013, 10 pages.
European Office Action for Application No. 13167979.7, dated Nov. 15, 2016, 8 pages.
International Preliminary Report on Patentability for PCT/EP2009/067181, dated Jun. 29, 2011, 9 pages.
International Search Report and Written Opinion for Application No. PCT/EP2009/067181, dated Mar. 22, 2010, 12 pages.
International Search Report and Written Opinion for International Application No. PCT/US2016/064790, dated Feb. 15, 2017, 17 pages.
International Search Report and Written Opinion for International Application No. PCT/US2016/064797, dated Feb. 15, 2017, 16 pages.
International Search Report and Written Opinion for International Application No. PCT/US2016/064806, dated Feb. 15, 2017, 18 pages.
International Search Report and Written Opinion for International Application No. PCT/US2016/64800, dated Feb. 16, 2017, 14 pages.
Japanese Notification of Refusal for Application No. 2011-541392, dated Jun. 14, 2013, 4 pages.
Japanese Notification of Refusal for Application No. 2014-165975, dated Jul. 17, 2015, 8 pages.
Korean Office Action for Application No. 1020117017187, dated Mar. 28, 2016, 11 pages.
Korean Office Action for Application No. 1020167029191, dated Nov. 17, 2016, 5 pages.
Notification of Reasons for Refusal for Application No. 2015-132034, dated Jul. 29, 2016, 5 pages.
ROTEM®, “Targeted therapy for coagulation management in patients with massive bleeding,” https://www.health.qld.gov.au/_data/assets/pdf_file/0023/427145/wp024.pdf, Nov. 2012, 30 pages, [brochure].
Calatzis et al., “Strategies to Assess Individual Susceptibility to abciximab Therapy Using a New Functional Assay,” Annals of Hematology, (Berlin, DE) vol. 76, No. Suppl 1, p. A61, XP009097526, 1998.
Chakroun et al., “The influence of fibrin polymerization and platelet-mediated contractile forces on citrated whole blood thromboelastography profile,” Thromb Haemost., 95(5):822-828, May 2006.
Greilich et al., “Near-site monitoring of the antiplatelet drug abciximab using the Hemodyne analyzer and modified thrombelastograph,” J Cardiothorac Vasc Anesth., 13(1):58-64, Feb. 1999.
Hartert, “Blood Coagulation Studies with Thromboelastography—A New Research Method,” Klin Wochenschrift 26:577-583, Oct. 1948 [English translation].
Kawasaki et al., “The effects of vasoactive agents, platelet agonists and anticoagulation on thrombelastography,” Acta Anaesthesiol Scand., 51(9):1237-1244, Oct. 2007.
Khurana et al., “Monitoring platelet glycoprotein IIb/IIIa-fibrin interaction with tissue factor-activated thromboelastography,” J Lab Clin Med., 130(4):401-411, Oct. 1997.
Nield et aI., “MRI-based blood oxygen saturation measurements in infants and children with congenital heart disease,” Pediatr Radiol., 32(7):518-522. Epub Apr. 16, 2002.
Nielsen et al., “Evaluation of the contribution of platelets to clot strength by thromboelastography in rabbits: the role of tissue factor and cytochalasin D,” Anesth Analg., 91(1):35-39, Jul. 2000.
Noon et al., “Reduction of blood trauma in roller pumps for long-term perfusion” World J Surg., 9(1):65-71, Feb. 1985.
Novotny et al., “Platelets secrete a coagulation inhibitor functionally and antigenically similar to the lipoprotein associated coagulation inhibitor,” Blood, 72(6):2020-2025, Dec. 1988.
Prisco and Paniccia, “Point-of-Care Testing of Hemostasis in Cardiac Surgery”, Thromb J., 1(1):1, May 6, 2003.
Rodzynek et al., “The transfer test: a new screening procedure for thrombotic diseases,” J Surg Res., 35(3):227-233, Sep. 1983.
Rotem® “When Minutes Count to Stop the Bleeding,” Pentapharm GmbH, www.rotem.de, 6 pages, Jun. 2007. [brochure].
Rugeri et al., “Diagnosis of early coagulation abnormalities in trauma patients by rotation thrombelastography,” J Thromb Haemost., 5(2):289-295, Epub Nov. 16, 2006.
Salooja and Perry, “Thrombelastography,” Blood Coagul Fibrinolysis, 12(5):327-37, Jul. 2001.
Shore-Lesserson et al., “Thromboelastography-guided transfusion algorithm reduces transfusions in complex cardiac surgery,” Anesth Analg., 88(2):312-319, Feb. 1999.
Soria et al., “Fibrin stabilizing factor (F XIII) and collagen polymerization,” Experientia, 31(11):1355-1357, Nov. 15, 1975.
Spannagl et al., “Point-of-Care Analysis of the Homostatic System,” Laboratoriumsmedizin, (Kirchheim, DE), 26(1-2):68-76, Feb. 2002.
Srinivasa et al., “Thromboelastography: Where Is It and Where Is It Heading?” Int'l Anesthesiology Clinics, 39(1):35-49, Winter 2001.
Tanaka et al., “Thrombin generation assay and viscoelastic coagulation monitors demonstrate differences in the mode of thrombin inhibition between unfractionated heparin and bivalirudin,” Anesth Analg., 105(4):933-939, Oct. 2007.
Japanes Office Action in International Application No. JP2015-191180, dated Nov. 17, 2017, (9 pages including English Translation).
Patent Publication Number: 20160091483
Assignee: C A Casyso AG (Basel)
Inventors: Cory Lee McCluskey (Encinitas, CA), Robert S. Hillman (San Diego, CA), Michael Gorin (Incline Village, NV), Hubert Martin Schwaiger (Munich)
Application Number: 14/500,248
International Classification: G01N 33/49 (20060101); B01L 3/00 (20060101); G01N 11/00 (20060101); G01N 33/86 (20060101);