Abstract:
Heat exchange pads are externally applied to a patient to induce therapeutic hypothermia. Anti-shivering agents may be administered to reduce shivering.

Description:
I. FIELD OF THE INVENTION  
       [0001]     The present invention relates generally to therapeutic hypothermia.  
       II. BACKGROUND OF THE INVENTION  
       [0002]     Mild or moderate hypothermia may be induced to improve the outcomes of patients suffering from such maladies as stroke, cardiac arrest, myocardial infarction, traumatic brain injury, and high intracranial pressure. The present assignee has covered one or more of the above treatments using an intravascular heat exchange catheter in U.S. Pat. Nos. 6,149,670, 6,290,717, 6,432,124, 6,454,793, 6,682,551, and 6,726,710 (collectively, “the Alsius treatment patents”), all of which are incorporated herein by reference.  
         [0003]     As recognized herein, shivering may accompany hypothermia, which not only can lead to patient discomfort but can also counter the therapy by warming the patient. U.S. Pat. Nos. 6,702,839, 6,582,457, and 6,231,594 (collectively, “the anti-shivering patents”), incorporated herein by reference, disclose various drugs and external heating blankets for alleviating such shivering in the context of intravascular heat exchange catheters. However, as also recognized herein, these latter three patents appear to fail to envision that hypothermia may be induced by means of externally applied pads such as those disclosed in U.S. Pat. Nos. 6,827,728, 6,818,012, 6,802,855, 6,799,063, 6,764,391, 6,692,518, 6,669,715, 6,660,027, 6,648,905, 6,645,232, 6,620,187, 6,461,379, 6,375,674, 6,197,045, and 6,188,930 (collectively, “the external pad patents”), all of which are incorporated herein by reference but none of which appear to recognize that shivering might occur when using external pads, much less what to do about it. The present invention rectifies this shortfall in the prior art.  
       SUMMARY OF THE INVENTION  
       [0004]     A method for treating a patient includes disposing at least one heat exchange pad against the external skin of the patient and exchanging heat with the patient using the pad to cool the patient by lowering the body temperature of the patient. The cooling can be done on a febrile patient to maintain normothermia or it can be done to induce therapeutic hypothermia in the patient. The method also includes administering at least one anti-shivering agent to the patient by, e.g., injecting a substance into the bloodstream of the patient. The method may also include diagnosing the patient as having had cardiac arrest or myocardial infarction or stroke, prior to inducing hypothermia.  
         [0005]     In another aspect, a system includes at least one pad that is configured for external placement on the skin of a patient and that is operable to cool the patient to induce hypothermia in the patient. A substrate is associated with the pad and bears instructions to administer an anti-shivering agent to the patient.  
         [0006]     In still another aspect, a method includes providing instructions to a medical practitioner. The instructions include placing a heat exchange pad or pads against the skin of a patient and inducing hypothermia in the patient using the pad or pads. The method also includes countering shivering in the patient.  
         [0007]     The details of the present invention, both as to its structure and operation, can best be understood in reference to the accompanying drawings, in which like reference numerals refer to like parts, and in which: 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0008]      FIG. 1  is a schematic view of a non-limiting system in accordance with the present invention; and  
         [0009]      FIG. 2  is a flow chart of a non-limiting method in accordance with the present invention. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0010]     Referring initially to  FIG. 1 , a system is shown, generally designated  10 , that includes one or more pads  12  that are positioned against the external skin of a patient  14  (only one pad  12  shown for clarity). The pad  12  is any one of the pads disclosed in the external pad patents. A substrate  16  such as a label that is affixed to the pad or an instruction manual that accompanies the pad can also be provided that bears instructions regarding the method set forth herein. In any case, the temperature of the pad  12  can be controlled by a controller  18  in accordance with principles set forth in the external pad patents to exchange heat with the patient  14 , including to establish normothermia in a febrile patient and to induce therapeutic mild or moderate hypothermia in the patient in response to the patient presenting with, e.g., cardiac arrest, myocardial infarction, stroke, high intracranial pressure, traumatic brain injury, or other malady the effects of which can be ameliorated by hypothermia.  
         [0011]     When hypothermia is induced in the patient, the patient may shiver, and it may be desirable to counter the shivering. The patient may be covered by a blanket but more preferably is treated by injecting, into the patient&#39;s bloodstream through an intravenous line  20 , one or more anti-shivering substances  22  that can be contained in a source  24  of anti-shivering drugs. The source  24  may be, without limitation, a syringe or IV bag or other source. In non-limiting embodiments the substance  22  may be any one of the substances disclosed in the anti-shivering patents.  
         [0012]      FIG. 2  shows that at block  26 , the patient presents with symptoms that are diagnosed as indicating hypothermia, e.g., the patient may be diagnosed with cardiac arrest, myocardial infarction, stroke, high intracranial pressure, traumatic brain injury, or other malady the effects of which can be ameliorated by hypothermia. At block  28 , the pad  12  is placed on the external skin of the patient, and at block  30  hypothermia is induced in accordance with the external pad patents. However, in accordance with the present invention, instead of allowing the patient to shiver, at block  32  the anti-shivering substance  22  or other therapy (e.g., warming blanket) is administered to the patient to counter the shivering.  
         [0013]     While the particular SYSTEM AND METHOD FOR REDUCING SHIVERING WHEN USING EXTERNAL COOLING PADS as herein shown and described in detail is fully capable of attaining the above-described objects of the invention, it is to be understood that it is the presently preferred embodiment of the present invention and is thus representative of the subject matter which is broadly contemplated by the present invention, that the scope of the present invention fully encompasses other embodiments which may become obvious to those skilled in the art, and that the scope of the present invention is accordingly to be limited by nothing other than the appended claims, in which reference to an element in the singular is not intended to mean “one and only one” unless explicitly so stated, but rather “one or more”. It is not necessary for a device or method to address each and every problem sought to be solved by the present invention, for it to be encompassed by the present claims. Furthermore, no element, component, or method step in the present disclosure is intended to be dedicated to the public regardless of whether the element, component, or method step is explicitly recited in the claims. Absent express definitions herein, claim terms are to be given all ordinary and accustomed meanings that are not irreconcilable with the present specification and file history.