|Publication number||USRE39075 E1|
|Application number||US 10/032,559|
|Publication date||Apr 18, 2006|
|Filing date||Jan 2, 2002|
|Priority date||May 27, 1986|
|Also published as||CA1271796A, CA1271796A1, DE3751504D1, DE3751504T2, EP0247989A2, EP0247989A3, EP0247989B1, US4759749|
|Publication number||032559, 10032559, US RE39075 E1, US RE39075E1, US-E1-RE39075, USRE39075 E1, USRE39075E1|
|Inventors||Wesley H. Verkaart|
|Original Assignee||Smiths Medical Asd, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (17), Referenced by (12), Classifications (15), Legal Events (2)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application is a continuation of application No. 08/758,853 filed Dec. 2, 1996, since abandoned, which is a continuation of application No. 08/571,706 filed Dec. 6, 1995, since abandoned, which is a continuation of application No. 08/145,099 filed Nov. 3, 1993, since abandoned, which is a continuation of application No. 07/979,434 filed Nov. 20, 1992, since abandoned, which is a continuation of application No. 07/558,177 filed Jul. 26, 1990, since abandoned, which is a reissue of application No. 06/866,910 filed May 27, 1986, U.S. Pat. No. 4,759,749.
This invention relates to the art of devices used with physiological fluids. In particular, the invention is an apparatus for heating a physiological fluid before introduction into a patient.
In many medical procedures, it is necessary that fluids to be administered to a patient be heated. For example, whole blood and packed cells are stored in refrigerators at a temperature of approximately 4° C. These fluids often are required to be administered to a patient within a short period of time, which necessitates warming them to a temperature approximately equal to that of the patient, i.e. 37° C.
Great care must be exercised when heating fluids such as whole blood or packed cells to avoid damaging the cells. For example, it is generally accepted that whole blood and packed cells should not be exposed to a temperature above 44° C. This places a severe restriction on the techniques used to heat quickly fluids which have been stored in a refrigerator and which must be administered to a patient within a short period of time.
U.S. Pat. Nos. 3,614,385 (Horstmann), 3,629,552 (Edging), 4,476,867 (Parks), and 4,532,414 (Shah et al.) teach systems for heating blood prior to being administered to a patient. The Horstmann, Edging, and Parks devices use various heat exchangers whereby blood flows through a tube which communicates with a warming fluid in a heat exchanger. It is quite difficult to maintain sterility of the heating apparatus in these systems after the first use because of the complexity of the heat exchangers. The Shah et al. device is simply a heated plate having a groove therein for receiving a tube leading from the bag containing the fluid to be administered.
U.S. Pat. No. 2,910,981 (Wilson et at.) shows a device for conducting blood transfusions. A heat exchanger is in fluid communication with a heating element, and the blood to be ministered passes through the heat ex. changer before being administered to the patient. The heat exchanger comprises a central tube surrounded by an outer tube, and the heating fluid passes through the space between the inner and outer tubes. The heat ex. changer is threadedly connected to valves at opposite ends. No structure is described for supporting the various elements described in the patent.
The invention is a self-contained, free standing system which permits controlled, but rapid heating of cellular fluids as they are being administered to a patient. The heating of the cellular fluids is controlled to prevent damage to the fluids from various causes including overheating.
The system comprises two major parts. A first part includes a heating element, a support pole, and a wheeled base. A second part comprises a heat exchanger and, optionally, a filter. The heat exchanger and filter are disposable and are removably attached to the support pole. The heat exchanger is disposable to facilitate each patient's use of a new, sterile heat exchanger.
The heat exchanger is easily installed on the pole, which includes a fixed mounting block and a movable mounting block. Opposite ends of the heat exchanger comprise nipples which are received in O-ring containing recesses in the mounting blocks. Thus, installation and removal of the disposable heat exchanger are quite easy.
The system may also include a filter which would be attached to an outlet of the heat exchanger. Sensors on the pole detect when the heat exchanger or the filter is in a correct place to control operation of the heating system. The heating system comprises a tank and a heating element in the outlet line of the tank. A pump circulates a heating fluid from the tank and heating element through the disposable heat exchanger.
Heat exchanger 10 is removably received by first detachable fluid connector 36 and second detachable fluid connector 38. The structure of fluid connectors 36 and 38 will be more fully described with respect to
Filter 12 is supported on pole 4 by U-shaped bracket 48. The distance between the legs of the bracket is slightly less than the diameter of the filter so that it “snaps” into place. Similarly, a U-shaped bracket 49 is located between connectors 36 and 38. Bracket 49 holds heat exchanger 10 aligned with connector 36 during insertion of the heat exchanger.
An outer tube 58 fits over the inner tube 50 in a central portion thereof The space between the helical central portion 56 and the outer tube 58 forms a helical path extending between opposite ends of outer tube 58.
An inlet connector 60 is secured to one end of outer tube 58 and includes connection 62 which receives tube 14 (see FIG. 2). End 52 of inner tube 50 extends beyond the upper edge of inlet connector 60 to provide a nipple for engagement with fluid connectors 36 as will be more fully described with respect to FIG. 4.
Outlet connector 64 is secured to a second end of outer tube 58, provides connection 66 for attachment to tube 18, and allows end 54 to project to form a nipple for being received in fluid connector 38.
Elbow 74 is threadedly connected to projection 70 to connect hose 28 with inner passage 76. Recess 78 connects with passage 76 and receives nipple end 52 of heat exchanger 10. O-ring seal 80 is received in an enlarged portion of recess 78 to provide a fluid-tight seal. It will be appreciated that fluid passing through hose 28 is thus connected to inner tube 50 of heat exchanger 10.
Fluid connector 38 is similar to fluid connector 36, except that connector 38 is secured to housing 24.
It will be appreciated that heat exchanger 10 may be easily attached to pole 4 by inserting end 54 into fluid connector 38 and by lowering fluid connector 36 onto end $2 52. When this is accomplished, heat exchanger 10 will be supported mainly by fluid connectors 36 and 38.
A base 88 supports electrical components 90, a pump motor 92, and a heater 94. A tank 96 sits on top of heater 94, and filter 98 is located between an outlet of the tank and an inlet of the heater. A fill port 100 is connected to the top of tank 96 to allow circulating fluid to be introduced into the system. Inlet 102 also connects to the top of tank 96 and receives circulating fluid from either hose 26 or 28, and outlet 104 supplies heated fluid to hose 28 or 26.
The warming fluid is driven through the heat exchanger circuit by pump 106 which is connected to the pump motor by magnetic clutch 108.
With particular reference to
Power is provided through power cord 126, and the voltage is adjusted by an isolation transformer 128. A switch 130 activates the entire electrical system, and the operation of the system, including the fluid temperature is displayed on panel 132.
In operation of the apparatus is accordance with the invention, the unit is rolled to a location adjacent to a patient, and a sterile unit 8 is installed between fluid connectors 36 and 38. Cannula 22 is attached to the patient, and bag spikes 16 are inserted into appropriate bags containing the desired fluid to be administered to the patient. Switch 130 is be warmed by the heat exchanger. If filter 12 has been placed in the circuit, the warmed body fluid then passes through the filter and into the patient. If filter 12 is not being used, tube 18 is connected directly to the cannula 22 for direct admission of the warm body fluid to the patient.
It will be appreciated that a unique self-contained unit has been described which provides sterility by use of an easily-installed disposable heat exchanger circuit. Modifications within the scope of the appended claims will be apparent to those who are skilled in the art.
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|Citing Patent||Filing date||Publication date||Applicant||Title|
|US7740611||Oct 17, 2006||Jun 22, 2010||Patented Medical Solutions, Llc||Method and apparatus to indicate prior use of a medical item|
|US8076618||Sep 10, 2008||Dec 13, 2011||Enthermics Medical Systems, Inc.||Modular fluid warmer|
|US8362402||Jul 19, 2010||Jan 29, 2013||Enthermics Medical Systems, Inc||Fluid warmer with switch assembly|
|US8444599||May 10, 2010||May 21, 2013||Patented Medical Solutions, Llc||Method and apparatus to indicate prior use of a medical item|
|US8613723||Jun 30, 2009||Dec 24, 2013||Smiths Medical Asd, Inc.||Multi lumen heat exchanger|
|US8636691||May 10, 2010||Jan 28, 2014||Patented Medical Solutions, Llc||Method and apparatus to indicate prior use of a medical item|
|US8845586||Mar 5, 2007||Sep 30, 2014||Patented Medical Solutions Llc||Method and apparatus for facilitating injection of medication into an intravenous fluid line while maintaining sterility of infused fluids|
|US20050177087 *||Feb 11, 2004||Aug 11, 2005||Steve Lee||Blood heat conserving tube assembly for hemodialysis or blood transfusion|
|US20100059498 *||Sep 10, 2008||Mar 11, 2010||Hansen William J||Modular fluid warmer|
|US20100222762 *||May 10, 2010||Sep 2, 2010||Faries Jr Durward I||Method and Apparatus to Indicate Prior Use of a Medical Item|
|US20100222763 *||May 10, 2010||Sep 2, 2010||Faries Jr Durward I||Method and Apparatus to Indicate Prior Use of a Medical Item|
|US20100276411 *||Jul 19, 2010||Nov 4, 2010||Hansen William J||Fluid warmer with switch assembly|
|U.S. Classification||604/113, 422/46, 604/6.11, 604/6.13, 604/151, 165/156, 165/67|
|International Classification||A61J1/16, A61M5/168, A61M5/14, A61F7/12, A61M5/44|
|Cooperative Classification||A61M5/44, A61M2205/366|
|Mar 26, 2002||AS||Assignment|
Owner name: LEVEL 1, INC., MASSACHUSETTS
Free format text: CHANGE OF NAME;ASSIGNOR:SIMS LEVEL 1, INC.;REEL/FRAME:012721/0875
Effective date: 20010701
|Mar 9, 2004||AS||Assignment|
Owner name: SMITHS MEDICAL ASD, INC., NEW HAMPSHIRE
Free format text: CHANGE OF NAME;ASSIGNOR:LEVEL 1, INC.;REEL/FRAME:015044/0700
Effective date: 20031222