Patent Publication Number: US-2020297529-A1

Title: System for hypothermia treatment of a patient

Description:
FIELD OF THE INVENTION 
     The present invention relates to a system for hypothermia treatment of a patient. 
     BACKGROUND ART 
     Systems for hypothermia treatment are known in the art. Placing catheters or tubes in or via the nasal cavity are known procedures in intensive care. The approach may be advantageous as it leaves the mouth free for treatment or for ventilation of the patient. One kind of cooling catheter is a balloon catheter, which may be inflated when in its intended position, such as the nasal cavity, whereby the heat conduction to the surrounding tissue will be made more efficient. Balloon catheters inserted into the nasal cavity can be used for different purposes. One application is to transfer energy to the surrounding tissue in therapeutic hypothermia treatment. A problem of the art with this kind of systems for hypothermia treatment is that it is difficult to insert the catheters into the nasal cavity of the patient without the catheters being contaminated in the process. Contamination may occur both during storage of the catheter just prior to insertion, and due to the insertion process itself, for example by the balloon catheter accidently touching an exterior part of the patient, such as a part of the face, or a contamination present on the medical personnel. 
     SUMMARY 
     It is an object to mitigate, alleviate or eliminate one or more of the above-identified deficiencies in the art and disadvantages singly or in any combination and solve at least the above mentioned problem. 
     According to a first aspect there is provided a system for a patient, the system comprising one or more devices, each of the one or more devices comprising: 
     a nasal cavity element, being a patient cooling element, adapted to be introduced through a nostril into the nasal cavity of the patent, 
     tubing, fluidly connected to the nasal cavity element, said tubing being arranged to provide a fluid to the nasal cavity element, 
     a sleeve slidably attached to said nasal cavity element and said tubing, 
     said sleeve being movable from a closed position at which the sleeve encloses and protects the nasal cavity element, and an open position at which at least a part of the nasal cavity element protrudes from the sleeve. 
     The proposed system may be advantageous as it may allow an improved resistance to contamination during handling and insertion into the nasal cavity prior to hypothermia treatment. By placing the nasal cavity element just outside a nostril of the patient, with the sleeve in its closed position thus covering and protecting it, the medical personnel may insert the nasal cavity element via the nose into the nasal cavity by holding the sleeve in a stable position in relation to the head of the patient using one hand, and gently sliding the nasal cavity element followed by the tubing connected to it into the nostril of the patient using the other hand. During the process, the sleeve will act both as a guide for inserting the nasal cavity element, and as a protective cover allowing to keep the nasal cavity element free from contamination. Furthermore, if the nasal cavity element is a balloon catheter, the sleeve will aid in keeping the balloon in a correct position during the insertion process so as to allow it to expand without any folding inside the nasal cavity. 
     According to some embodiments, the sleeve is a tube surrounding the nasal cavity element and the tubing. 
     According to some embodiments, the sleeve comprises a plastic material. The dimensions of the sleeve may vary dependent on the type of tubing used. According to some embodiments, an inner diameter of the sleeve is 3 times larger than an outer diameter of the tubing. 
     According to some embodiments, the first and second tube is arranged in parallel and in attachment with each other. The first and second tube may be made of a flexible material. According to some embodiments, the first and second tube is made of a plastic material, the first and second tube being attached to each other by welding. 
     According to some embodiments, the nasal cavity element is a luminary catheter, such as a balloon catheter, arranged to be expandable inside the nasal cavity of the patient. 
     According to some embodiments, the system further comprises a positioning strap being adapted to be fixated around the head of the patient, said positioning strap comprising: 
     one or more fixation elements adapted to fixate said tubing to the positioning strap in a respective fixation point, said one or more fixation elements being pivotable around said respective fixation point. 
     The positioning strap may be advantageous as it allows keeping the tubing fixed in relation to the head of the patient, once the nasal cavity element have been correctly inserted into the nasal cavity. That said, the one or more fixation elements being pivotable allows for a more flexible and comfortable fixation which is beneficial for both the patient and the medical personnel. 
     According to some embodiments, each of the one or more fixation elements comprises at least one recess for holding and fixating tubing therein. The at least one recess may be curved. This may be an advantageous solution as it provides a way to fixate tubing to a fixation element merely by disposing the tubing inside the recess, thus avoiding the need for any additional locking mechanisms. The curved recess provides a way to fixate the tubing to the fixation element purely by frictional forces between the tubing posterior and the inner surfaces of the at least one recess. The curvature of the recess may vary dependent on the tubing used. According to some embodiments, the radius of the curvature of the at least one recess is less than 3 times a width of the recess. 
     According to some embodiments, the at least one recess is tapered such that a width of the recess at the bottom thereof is smaller than a width of the recess at a top thereof. This implies that side walls of the recess will have an inclination, or alternatively, that opposing side walls of the recess will be un-parallel and form an angle with each other. The use of a tapered recess may increase the effectiveness of fixation to the fixation element as the tubing will be squeezed and kept in place by frictional forces. The inclination of the side walls of the recess may be different for different types of tubing. According to some embodiments, the angle between the opposing side walls is 22°. 
     According to some embodiments, the one or more fixation elements are removably attached to the positioning strap by means of a respective push button. This may be an advantageous solution as it allows replacing worn out fixation elements. Also, it allows the positioning strap to be custom-built for a specific use. Thus, for some embodiments, the positioning strap may have only one fixation element for fixating the tubing of two catheters. In other embodiments, the positioning strap may have four fixation elements, wherein each fixation elements holds one tube of the tubing. 
     According to some embodiments, the system comprises two devices, the nasal cavity elements of which are each adapted to be introduced through a respective nostril of the patient. 
     According to some embodiments, the one or more fixation elements are two fixation elements fixated to a respective fixation point distanced from each other along a circumferential direction of the strap, and wherein each fixation element being adapted to fixate tubing of a respective one from the two devices in said respective fixation point. 
     According to a second aspect there is provided a positioning strap for fixating a system for hypothermia treatment of a patient, said positioning strap being adapted to be fixated around the head of the patient, said positioning strap comprising: 
     one or more fixation elements adapted to fixate tubing of the system to the positioning strap in a respective fixation point, said one or more fixation elements being pivotable around said respective fixation point. 
     According to some embodiments, each of the one or more fixation elements comprises at least one recess for holding and fixating tubing therein. 
     According to some embodiments, the at least one recess is curved. 
     According to some embodiments, the radius of the curvature of the at least one recess is less than 3 times a width of the recess. 
     According to some embodiments, the at least one recess is tapered such that a width of the recess at the bottom thereof is smaller than a width of the recess at a top thereof. 
     According to some embodiments, the one or more fixation elements are two fixation elements fixated to a respective fixation point distanced from each other along a circumferential direction of the strap. 
     According to some embodiments, the one or more fixation elements are removably attached to the positioning strap by means of a respective push button. 
    
    
     
       BRIEF DESCRIPTIONS OF THE DRAWINGS 
       The invention will by way of example be described in more detail with reference to the appended [schematic] drawings, which shows presently preferred embodiments of the invention. 
         FIG. 1  shows a cross sectional view of a system for hypothermia treatment of a patient according to embodiments of the present disclosure. 
         FIG. 2A  shows a perspective view of a system for hypothermia treatment of a patient according embodiments of the present disclosure just prior to inserting the nasal cavity member into the nostril of the patient. Here the sleeve is in its closed position. 
         FIG. 2B  shows a perspective view of a system for hypothermia treatment of a patient according embodiments of the present disclosure during insertion of the nasal cavity member through the nostril of the patient. Here, the sleeve is in its open position. 
         FIG. 3A  shows a perspective view of a positioning strap positioned around the head of a patient according to embodiments of the present disclosure. 
         FIG. 3B  shows a perspective view of the positioning strap of  FIG. 3A  when holding tubing of a device. 
         FIG. 4A  shows a perspective view of a fixation element according to embodiments of the present disclosure. 
         FIG. 4B  shows a cross sectional view of the fixating element along the line  4 B- 4 B shown in  FIG. 4A . 
         FIG. 5  shows a perspective top view of a system and a positioning strap according to alternative embodiments of the disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     The present invention will now be described more fully hereinafter with reference to the accompanying drawings, in which currently preferred embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided for thoroughness and completeness, and fully convey the scope of the invention to the skilled person. 
       FIG. 1  shows a cross sectional view of a system  100  for hypothermia treatment of a patient  10 . The purpose of the system  100  is to provide temperature control to at least parts of the body of the patient  10 . Specifically, for the embodiment, the system  100  provides cooling to the brain  16  of the patient  10  via the nasal cavity  12 . The system  100  comprises one or more devices  110   a,    110   b,  in the form of cooling devices, each of the one or more devices  110   a,    110   b  comprising a nasal cavity element  120   a,    120   b  adapted to be introduced through a nostril into the nasal cavity  12  of the patent  10 . Specifically, for the example embodiment, the system  100  comprises two devices  110   a,    110   b,  the nasal cavity elements  120   a,    120   b  of which are each adapted to be introduced through a respective nostril of the patient  10 . In the example, the nasal cavity elements  120   a,    120   b  are luminary catheters such as balloon catheters arranged to be expandable inside the nasal cavity  12  of the patient  10 . The balloon catheters  120   a,    120   b  are expanded by means of pressurizing a cooling fluid present within the balloon catheters  120   a,    120   b.    
     The cooling fluid is supplied to the balloon catheters  120   a,    120   b  by means of tubing  130   a,    130   b  which are fluidly connected to the nasal cavity element  120   a,    120   b.  In  FIG. 1 , only one tube is shown for increased clearness. However, as illustrated in  FIG. 4A , typically the tubing  130   a,    130   b  comprises a first tube  231   a,    231   b  for allowing the cooling fluid to enter the nasal cavity element  120   a,    120   b,  and a second tube  232   a,    232   b  for allowing the cooling fluid to leave the nasal cavity element  120   a,    120   b.  The first  231   a,    231   b  and second  232   a,    232   b  tube is, for each tubing  130   a,    130   b  of the example embodiment of  FIG. 4A , arranged in parallel and in attachment with each other, thus forming a single supply unit for both inlet and outlet of cooling fluid to each balloon catheter  120   a,    120   b.  However, alternatively, the first  231   a,    231   b  and second  232   a,    232   b  tube may be separate from each other. In such a case, the system may comprise four separate tubes, two inlet tubes and two outlet tubes. The tubing  130   a,    130   b  is connected to an external heat regulating system comprising heat regulatory units and pumps. The heat regulating system is not explicitly disclosed herein. It should be understood that many alternative ways exist for achieving such a heat regulating system within the scope of the claims. 
     Each device of the system  100  further comprises a sleeve  140   a,    140   b  slidably attached to the balloon catheter  120   a,    120   b  and the tubing  130   a,    130   b.  The sleeve  140   a,    140   b  is movable from a closed position A at which the sleeve  140   a,    140   b  encloses and protects the nasal cavity element  120   a,    120   b,  and an open position B at which at least a part of the nasal cavity element  120   a,    120   b  protrudes from the sleeve  140   a,    140   b.  This is illustrated in  FIG. 2A  showing the sleeve in its closed position A just prior to inserting a balloon catheter into a nostril of the patient  10 . Thus, the medical personnel may insert each balloon catheter  120   a,    120   b  via the nose into the nasal cavity  12  by holding the respective sleeve  140   a,    140   b  in a stable position in relation to the head  14  of the patient  10  using one hand, and gently sliding the balloon catheter  120   a,    120   b  followed by the tubing  130   a,    130   b  connected to it into the respective nostril of the patient  10  using the other hand. During the insertion process, each sleeve  140   a,    140   b  will act both as a guide for inserting the respective balloon catheter  120   a,    120   b,  and as a protective cover allowing to keep the respective balloon catheter  120   a,    120   b  free from contamination. Specifically, the sleeve  140   a,    140   b  aids in defining the direction of insertion of the balloon catheter  120   a,    120   b  in relation to the head  14  of the patient  10 , as illustrated in  FIG. 2A  using the angle α. Typically, the angle α is within the interval 40-80°. As illustrated in  FIGS. 2A and 2B , each sleeve  140   a,    140   b  is a tube surrounding the respective balloon catheter  120   a;    120   b  and tubing  130   a,    130   b.  The inner diameter of the sleeve  140   a,    140   b  is typically 2-3 larger than the diameter of a tube of the tubing  130   a,    130   b.  The sleeve  140   a;    140   b  comprises a plastic material. 
     As illustrated in  FIGS. 2A and 2B , the system  100  further comprises a positioning strap  150  being adapted to be fixated around the head  14  of the patient. The positioning strap  150  comprises one or more fixation elements  160   a,    160   b  adapted to fixate the tubing  130   a,    130   b  to the positioning strap  150  in a respective fixation point  152   a,    152   b.  The one or more fixation elements  160   a,    160   b  are pivotable around the respective fixation point  152   a,    152   b,  thus allowing for a flexible and comfortable fixation which is beneficial for both the patient and the medical personnel. Specifically, the one or more fixation elements  160   a,    160   b  are removably attached to the positioning strap  150  by means of a respective push button  170   a,    170   b.  This provides a convenient solution where the number of fixation elements may be varied dependent on the task. Only one fixation element  160   a  is shown in  FIGS. 2A  and B. Another fixation element  160   b  may be fixated to the positioning strap  150  in the fixation point  152   b  on the other side of the nose. This is further illustrated in  FIG. 5 . 
     Each of the one or more fixation elements  160   a,    160   b  comprises at least one recess  162   a  for holding and fixating tubing  130   a,    130   b  therein. An example embodiment of the fixation element  160   a  comprising a single recess  162   a  is illustrated in  FIGS. 3A and 3B . As most clearly seen in  FIG. 3B , the recess  162   a  is curved. The radius of the curvature of the recess  162   a  is less than 3 times a width of the recess  162   a.  The curved recess  162   a  provides a way to fixate the tubing  130   a  to the fixation element purely by frictional forces between the tubing posterior and the inner surfaces of the recess  162   a.    
     In the example embodiment shown in  FIGS. 3A and 3B , the fixation element  160   a  is arranged to fixate one tube only. Thus, if two devices  110   a,    110   b  are used where each device  110   a,    110   b  being connected to two tubes, altogether four fixation elements would be needed. In an alternative example embodiment, a fixation element may be arranged to fixate more than one tube. This is illustrated in  FIGS. 4A and 4B  showing a fixation element  260   a  arranged to fixate two tubes, in this case an inlet and outlet tube for the balloon catheter  120   a.  Specifically, the tubing  130   a  comprises a first tube  231   a  for allowing the cooling fluid to enter the nasal cavity element  120   a,  and a second tube  232   a  for allowing the cooling fluid to leave the nasal cavity element  120   a.  The first  231   a  and second  232   a  tube is in the example embodiment of  FIG. 4A  arranged in parallel and in attachment with each other, thus forming a single supply unit for both inlet and outlet of cooling fluid to the balloon catheter  120   a.  As most clearly seen in the cross sectional view in  FIG. 4B , the at least one recess  262   a  is tapered such that a width wb of the recess  262   a  at the bottom  264   a  thereof is smaller than a width wt of the recess  262   a  at a top  266   a  thereof. 
     As previously mentioned, the number of fixation elements may be varied dependent on the task and/or the example embodiment. According to one example embodiment, the one or more fixation elements are two fixation elements  160   a,    160   b  fixated to a respective fixation point  152   a,    152   b  distanced from each other along a circumferential direction L of the strap  150 . This is best illustrated in  FIG. 5  showing a perspective top view of a system  200  using two devices  210   a  and  210   b  fixated to the positioning strap  150  by the first fixation element  260   a  on one side of the nose and the second fixation element  260   b  on the other side of the nose, respectively. The other fixation element  160   b  may be fixated onto the button  170   b  (not shown in  FIG. 5 ) or, alternatively, on another button (e.g. the button  170   c  or  170   d ) available on the positioning strap  150 . Specifically, for the example embodiment of the positioning strap shown in  FIG. 5 , there are four buttons,  170   a - d,  of which the buttons  170   a  and  170   b  are used for fixating the fixation elements  160   a  and  160   b,  respectively, whereas the buttons  170   c  and  170   d  are not used. Each fixation element  160   a,    160   b  is adapted to fixate tubing  130   a,    130   b  of a respective one from the two devices  110   a,    110   b  in said respective fixation point  152   a,    152   b.    
     The person skilled in the art realizes that the present invention by no means is limited to the preferred embodiments described above. On the contrary, many modifications and variations are possible within the scope of the appended claims. 
     For example, the tubing may be fixated to the fixation elements in other ways than disclosed herein. For example, a locking mechanism, such as a clamp may be used. 
     Additionally, variations to the disclosed embodiments can be understood and effected by the skilled person in practicing the claimed invention, from a study of the drawings, the disclosure, and the appended claims.