JP2016073697A - Artery cooling member and use method thereof - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a tool and a method for cooling the carotid artery.SOLUTION: A tool comprises a cervical spine fixing collar 10 comprising: an annular support structure 12 extending in an axial direction with predetermined length; two or more cheek support structure parts having predetermined vertical length; and a front opening part 28 capable of being covered with a door 30. The door comprises a body side surface and outside surface capable of holding a compression member. In addition, the tool and the method further comprise a cooling member disposed in the front opening part, and disposed between a neck front part of a patient and the compression member disposed on the door, so that the cooling member can be held to the annular support structure.SELECTED DRAWING: Figure 1

Description

  The present invention integrates techniques related to cervical spine fixation and treatment that introduces mild brain cryotherapy by percutaneous cooling of oxygen-received blood flowing through the carotid artery.

  Cervical spine collars are often used by early responders, such as paramedics, to stabilize the patient's neck, head and spine immediately after trauma occurs. In general, this procedure is effective in preventing further damage as it helps to begin treating the patient's trauma before arriving at the hospital. One method of treatment involves cooling the patient's brain. Cooling the brain, that is, reducing the brain temperature slightly by 1 ° or 2 ° Celsius, produces a neuroprotective effect against the harmful reactions associated with brain damage. This mild brain hypothermia suppresses the release of neuroexcitatory amino acids (eg, asparagine and glutamine), thereby preventing the cascade effect of the inflammatory response. The neuroprotective effect is most evident if brain cooling is done as soon as possible after injury.

  The protocol for early responders generally does not incorporate an effective treatment to initiate brain cooling. For example, it is known to apply a cooling pack to the groin, skull, and armpit of a patient's body. However, this type of cooling results in whole body cooling rather than selective cooling and is not effective in reducing the patient's brain temperature.

(Aspect of the Invention)
The carotid artery cooling device has a cervical spine fixing collar and a cooling member. The cervical spine collar can be obscured by an annular support structure extending axially with a predetermined length, two or more cheek support structures having a predetermined vertical length, and a door Includes a front opening. The door has a body side surface that can hold the compression member and an outer surface. In addition, the device includes a cooling member disposed within the front opening and positioned between the patient's neck front and a compression member disposed on the door to retain the annular support structure. .

  In other embodiments, the cooling member is at least partially covered by a lining. The cooling member may include an endothermic material that is activated by being distorted. In another embodiment, the compression members are two or more foam inserts located on the sides of the door that are used to apply pressure to the location of the cooling member corresponding to the carotid portion of the patient. Is included.

  In other embodiments, the door and the front opening have a first end and a second end. The door can be attached to the front of the support structure by a hinge at the first end of the front opening. Similarly, the second end portion of the door can be attached to the front portion of the support structure at the second end portion of the front opening.

  In another embodiment, the door and the front opening have a shape substantially similar to the shape of the cooling member. In other embodiments, the annular support structure has a rear opening.

FIG. 6 is a perspective view of a cervical spine fixation collar. FIG. 6 is an upper view of a cervical spine fixation collar. It is a front view of a cervical spine fixation collar. It is a top view of the cooling member used in a cervical vertebra fixation collar. It is the graph which displayed the temperature obtained by the activated cooling member over time. It is a top view of the cooling member used with a neck band. It is a rear view of a cervical spine fixation collar.

  The cervical spine fixation collar 10 can be used to fix a patient's spine, neck and head immediately after trauma. As shown in FIGS. 1-3 and 7, the cervical fixation collar 10 used with the cooling member generally includes a front portion 16 that wraps around the patient's neck and a back portion 18 that wraps around the patient's neck. An annular support structure 12 is provided. The front part 16 and the rear part 18 may be formed of a single material. In another form, the front part 16 and the rear part 18 may be separate components connected on one or both sides of the neck by a joint or a coupling mechanism such as a hook-and-loop fastener. The annular support structure 12 can be formed from a variety of materials including plastic, polymer, or carbon fiber or polyparaphenylene terephthalamide fiber (preferably injection or injection molding). In one embodiment, the annular support structure 12 is made of SCLAIR® 2712 high density polyethylene manufactured by NOVA Chemicals, which is represented by Entec Polymers.

  2 and 3, the hook and loop fastener strap 20 (see FIG. 3) is secured to the mating hook and loop patch (shown) on the proximal end 24 of the front portion 16 of the annular support structure 12. (Not shown) extends from the distal end 22 of the rear portion 18 so as to be detachable.

  The front portion 16 of the annular support structure 12 includes a cheek support structure portion 26. The cheek support structure portion 26 extends substantially vertically from both sides of the chin rest 14 and is configured to substantially cover an area related to the patient's cheek. The cheek support structure 26 can be used to prevent significant rotational or horizontal movement of the patient's head. The cheek support structure 26 may be integrally formed as part of the annular support structure 12 as shown, or may be formed separately and annularly supported by a suitable adhesive or coupling mechanism. It may be fixed on the structure 12. In other embodiments (not shown), the annular support structure 12 may not include a cheek support.

  Referring again to FIG. 1, the cervical fixation collar 10 further includes an anterior opening 28 in the anterior portion 16 of the annular support structure 12. The front opening 28 is constituted by a frame of the annular support structure 12. Conventional cervical supports may have an opening in the front of the support, which is used to ensure a passage to the patient's trachea when the airway is blocked It is only configured to be sufficiently large. Alternatively, the anterior opening 28 of the cervical spine fixation collar 10 is designed to cross the anterior part of the patient's neck so that both sides of the patient's carotid artery are exposed and face only the trachea.

  As shown in FIG. 2, the cervical spine fixation collar 10 further includes a door 30 that covers the anterior opening 28. In this embodiment, the first end of the door 30 is attached to the frame of the annular support structure 12 by a hinge 32 or other suitable fastening mechanism at one end or the first end of the front opening 28 or the periphery thereof. It is attached. As shown in FIGS. 1 and 2, in one embodiment, a two-part hinge is used. In this embodiment, the first portion 34 of the hinge is integrally formed as part of the frame of the annular support structure 12. Specifically, the first part 34 of the hinge may consist of one, preferably three, elastically deformable flanges. The second portion 36 of the hinge may be integrally formed as a part of the first end portion of the door 30. The second part 36 of the hinge can be fitted into the first part 34 of the hinge by deforming the flange portion. Once fitted, the second hinge portion 36 can rotate within the flange of the first hinge portion 34, thereby allowing the door 30 to open and close relative to the frame of the annular support structure 12. . In another embodiment, the hinge 32 may be a living hinge (not shown) integrally formed between the first end of the door 30 and the frame of the annular support structure 12.

  The second end of the door 30 has an annular support structure at the second hook-and-loop strap 38 (see FIG. 3) extending from the second end of the door 30 and the second end of the front opening 28 and the vicinity thereof. It can be fastened to the frame of the annular support structure 12 at the second end of the front opening 28 by means of a mating surface fastener patch (not shown) fixed on or around the frame of the body 12. This closure structure may be realized by a snap-fit mechanism, a press-fit mechanism, a button, a latch, an adhesive, or other suitable fastening mechanism.

  As described above, the front opening 28 extends substantially across the majority of the front portion 16 of the annular support structure 12. However, the fixed collar 10 must be strong enough to support the patient's neck and prevent bending movements and movements where the chin is lowered toward the chest. In conventional cervical supports, this strength is provided by the construction material between the chin rest and the bottom of the support. However, the large front opening 28 and the lack of construction material between the chin rest 14 and the bottom of the collar 10 must be compromised in terms of strength and support provided by the stationary collar 10, especially in the vertical plane. It may not be. Thus, even when the collar 10 is worn, the patient may be able to move the head up and down. For this reason, a support member is incorporated into the annular support structure 12 to provide the required support and to significantly prevent the patient from moving the head up and down.

  As shown in FIG. 1, the horizontally projecting edge 40 extends at a right angle from the bottom end 42 at the front of the annular support structure 12. In certain embodiments, the edge 40 may be integrally formed as part of the annular support structure 12 and preferably extends in a manner that traverses the entire front portion 16 of the frame of the annular support structure 12. ing. Similarly, as shown in FIG. 1, the door 30 includes a shelf 44 extending therein at a right angle from the top end of the door 30 toward the patient's body. The shelf 44 may be integrally formed as a part of the door 30. Further, the shelf 44 may include a notch 46 that allows the shelf 44 to bend as part of the door 30 during use.

  When the door 30 is closed as shown in FIG. 3 and the patient attempts to move his head down, the bottom 48 of the door 30 contacts the rim 40. Similarly, the shelf 44 on the door 30 (see FIGS. 1 and 2) will contact the bottom of the chin rest 14, impeding the lowering action, and the constituent material between the chin rest 14 and the bottom of the collar 10. As a result, the door 30 is effectively used.

  In addition, side ribs 50 a and 50 b may be included in the front portion of the annular support structure 12 to increase structural support. As shown in FIGS. 2 and 3, the side ribs 50 a and 50 b are integrally formed on the outer surface of the annular support structure 12 and extend from below the top end of the cheek support structure 26 to contact the edge 40. Yes. As shown in FIG. 3, the side rib 50 b is formed of two separate pieces, and the first one extends from the top end of the cheek support portion 26 in consideration of the contact with the surface fastener on the door 30. Extends upwardly from the edge 40.

  The cervical spine fixation collar 10 can be used in conjunction with the cooling member 52. The cooling member 52 shown in FIG. 4 has a shape that is substantially similar to or slightly larger than the shape of the front opening 28, but may have a different shape. The cooling member 52 has a body side panel 54 and an outer panel (not shown) that are closed at the ends with a heat activated adhesive seal or other suitable sealing mechanism. In some embodiments, the body side panel 54 and the outer panel are formed of one material sheet folded in half and sealed at the open end, or two material sheets sealed at all ends. It may be. The cooling member 52 may include a coolant that exhibits an endothermic reaction, such as a gel that has been cooled in advance or another material that has a heat absorption capability. It is preferable to use the cooling member 52 immediately after the components of the endothermic pack are activated once by mixing or other methods.

  In some embodiments, the panel may have a lining that covers at least the body side panel 54 of the cooling member 52 that will contact the patient's neck. In some embodiments, the lining largely covers the body side panel 54 of the cooling member 52. In other embodiments, both panels of the cooling member 52 are covered with a lining. The lining may be made, for example, of a cloth of non-woven material, and provides comfort and can be used to prevent skin irritation, skin deterioration, and potential frostbite. The lining may be attached to the panel or may be removable.

In certain embodiments, the panel of cooling members includes a backing composed of a non-woven material attached to cover a majority of one or both panels. The panel may be made of a thin film material. In one example, a 0.007 mm non-woven backing is thinly overlaid on a 2.5 mm linear low density white polyethylene film to form both panels of the cooling member 52. Yes. The moisture permeability of the panel can be 0.41 grams / 100 square inches (645.16 cm ² ) / 24 hours and the oxygen permeability is 9.0 cc / 100 square inches (645.16 cm ² ) / 24. Can be less than hours.

  In this embodiment, the cooling member 52 is about 10-12 inches (about 25.4-30.48 cm) long, about 90-110 grams of urea, about 45-55 grams of Carbamaool®. And contains water. In other embodiments, the cooling member 52 may be about 10 inches (about 25.4 cm) long and includes about 100 grams of urea, about 50 grams of Carbamaool®, and water. You may go out. In another embodiment, the cooling element 36 may be about 11 inches long and about 110 grams urea, about 55 grams Carbamaool®. And contains water. In these embodiments, urea crystals and Carbamaool® are mixed together and sealed between the panels of the cooling member 52. In this embodiment, the cooling member 52 further includes a breakable packet (not shown) filled with a liquid (preferably water). This liquid-filled packet is also sealed between the panels of the cooling member 52. To activate the cooling member 52, the user applies pressure to the cooling member 52 to rupture the wrap and wet the urea and Carbamaool®. Thereafter, the user shakes and mixes the cooling member 52 in order to mix the components and start the endothermic reaction.

  The coolant in the cooling member reaches a temperature of 20 ° F. to 45 ° F., preferably 25 ° F. to 35 ° F. during activation, and is about 10 to 30 minutes, preferably about 15 to 20 ° F. It is desirable for the minute to maintain its temperature. Suitable coolant for the cooling member 52 is available from New York 11735, Sherwood Avenue Farmingdale 125, Nortech Labs.

  Unlike conventional cooling packs with instructions to the user so that they are not placed directly on the patient's skin, the cooling member 52 with the backing cloth thinly overlaid on the panel is within 20-30 minutes. Meanwhile, the user can place the cooling member 52 directly on the patient's skin. Furthermore, thinly overlaying or adhering the lining cloth to the panel film prevents the cooling member 52 from being displaced, and prevents the carcass from falling off during use on the patient's neck.

  The temperature drop caused by the mixing of urea, Carbamaool® and water is measured on the outer surface of the cooling member 52. In other words, the temperature at which the patient comes into contact is measured by evaluating the amount of heat removal realized by the cooling member 52. However, since the use of the lining cloth isolates the cooling member 52, the internal volume of the cooling member 52 and the amount of urea and Carbamaool (R) used therein are adequate to remove heat from the patient's carotid artery. It is important to realize

  One lot of the cooling member 52 was tested as samples A to E according to the example. Each sample is 10 inches (25.4 cm) in length and contains 100 grams of urea and 50 grams of Carbamaool®. Both panels of Samples A to E are configured by thinly layering a 0.007 mm nonwoven lining on a 2.5 mm linear low density white polyethylene film.

The sample was activated by crushing the sample to break the water-fillable fragile packet sealed in the panel, and then the sample was shaken 10 times. The sample was folded and placed in a 16 ounce (453.6 gram) styrofoam cup. An ambient temperature of 68.7 ° F. was recorded and a thermocouple was placed in the fold of each cooling member (sample) about 1 inch (2.54 cm) from the bottom of the cup. The temperature recording was performed once per minute, and the last recording after 30 minutes. Each cooling member (sample) was shaken again after 2 minutes. The results are shown in Table 1 below.

Samples A-E were compared to a commercially available unlined cooling pack (Manufacturing Code 10-01) (Comparative Examples A-E) from 23831 Chester, PO, 2157, Medlogix, Virginia. Many unlined commercial code packs are composed of urea and water. Comparative Examples A to E were activated by being shaken 10 times after being crushed. The comparative example was folded and placed in a 16 ounce (453.6 gram) styrofoam cup. An ambient temperature of 68.7 ° F. was recorded and a thermocouple was placed in each comparative fold about 1 inch (2.54 cm) from the bottom of the cup. The temperature recording was performed once per minute, and the last recording after 30 minutes. Each comparative example was shaken again after 2 minutes. The results are shown in Table 2 below.

The average temperature of each time was compared and the comparative example was compared with the cooling member (sample). The results are shown in Table 3 below.

  As shown in FIG. 5, the lined cooling member 52 (classified as Series 1) was surprisingly activated and reached an average temperature of 31.46 ° F. within 1 minute (time of FIG. 5). Shown in 2 minutes). The cooling member continues to cool to an average minimum of 27.14 ° F. within 4 minutes of activation and maintains 35 ° F. or less for at least 30 minutes. In contrast, the unlined Medlogix conditioning cooling pack (series 2 in FIG. 5) does not achieve the desired average temperature within 1 minute of activation. In particular, Medlogix cooling packs, as shown in series 2, maintain an average value between 45 ° F. and 50 ° F. without reaching the desired temperature.

  In addition, the cooling member 52 can be used without the cooling collar 10 to treat pain or perform selective brain cooling via the carotid artery when head and neck damage is not suspected. In this embodiment shown in FIG. 6, the cooling member can be used in the form of a neck band including a cooling member 52 and a left wing 62 and a right wing 64 attached to each end of the cooling member. The cooling pack 52 is activated and can be placed over the patient's carotid artery by means of the wings 62, 64, with a suitable fastener such as a hook-and-loop fastener (not shown) wrapped around the patient's neck. The attachment mechanism allows one to be attached to the other at the back of the neck.

  In other embodiments, the cooling member 52 may have one or more endothermic packs that include compartments of ammonium nitrate and water separated by a tearable thin film. In this embodiment, the cooling member 52 can be activated by deforming the cooling member 52 to apply a pressure difference between the compartments or otherwise break the thin film.

  In use, the cervical fixation collar 10 is placed around the patient's neck and the cooling member 52 is activated and placed in the anterior opening 28. Then, the door 30 is closed over the cooling member 52, and the cooling member 52 is held between the door 30 and the patient's neck. The cooling member 52 generally overlaps the carotid portion of the patient's neck and functions as a cooler to extract heat from the blood flowing through the patient's carotid artery. Preferably, the cooling member 52 follows the characteristics of the individual patient's neck, thereby maximizing the contact area of the skin and more efficiently extracting heat from the neck tissue near the carotid artery. In some embodiments, the cooling member 52 is fitted to the patient's neck using a compression member 56 secured on the body side of the door 30.

  In particular, as shown in FIG. 7, the door 30 has a body side surface and an outer side surface (see FIG. 2). As shown, the side of the body has two spaced apart compression members 56 that extend toward the patient and are pyramid shaped. These compression members 56 may be formed in other shapes, including blocks, cylinders, or any other suitable shape that extends toward the patient when the door 30 is closed. The compression member 56 is disposed on the side of the body where the pressure is applied to the cooling member 52 so as to make maximum contact with the skin in the carotid artery region when the collar 10 is used. The compression member 56 may be formed integrally with the body side surface of the door 30 or may be attached to the body side surface of the door 30 by an appropriate means including an adhesive. Alternatively, the compression member 56 may be made of a foamable material, plastic, or other suitable material. In some embodiments, the compression member 56 may be made of an open cell urethane foam having a density of 2.8 pounds (1270 grams). The compression member 56 should be formed so that pressure applied to the patient's carotid artery does not block the patient's airway.

  As shown in FIG. 7, a foam layer 58 is lined on the side of the body of the annular support structure 12 to better fit the patient's neck. The foam layer can be formed of open or closed cell foam or other suitable material. In this embodiment, the annular support structure 12 and the foam layer 58 have a posterior rectangular opening 60 in the posterior portion 18 to provide a passage to the patient's posterior neck when additional medical procedures are needed. Have. In other embodiments, there are no openings in the rear portion 18 of the present invention.

  In addition, a sensor (not shown) placed in the vicinity of one of the patient's carotid triangles to monitor one or more blood circulation parameters such as arterial oxygen saturation, heart rate, blood pressure and blood temperature, It can also be incorporated into a fixed collar. In order to place this sensor in direct contact with the patient's skin, it is also necessary to redesign or replace part of the cooling member. In order to record the information collected by the sensor, a recording device (not shown) can be installed inside or outside the collar or somewhere else. Other sensors can be placed in other suitable locations within the collar to monitor various body parameters, including body temperature, or to monitor the condition of the fixed collar itself. For example, a temperature measuring means such as a thermochromic piece may be used to monitor the temperature of the collar or cooling member.

  An indicator (not shown) may be placed on the outer lateral surface of the rear part of the same cervical spine fixation collar. This indicator can be used to monitor other data collected by other sensors installed in the collar in addition to blood circulation data collected by the sensors. In addition, communication ports (not shown) can be formed in color to transmit data from one or more sensors to an external device.

  The cervical spine collar allows a new protocol for the treatment of trauma patients, including those with head trauma, heart attack, ischemic stroke, headache, epilepsy, heat stroke, shaking, or similar symptoms To. It is envisioned that this protocol will be used for home use by paramedics, in hospitals, or by athletic trainers or others. This treatment facilitates limiting rotation and compression of the patient's cervical vertebrae, attaching a cervical fixation collar around the patient's neck, and collars and cooling members for selective brain cooling procedures via the carotid artery And in service. This protocol induces selective cooling of the core brain and minor hypothermia without causing systemic cooling of the body by inducing vasodilation of the patient's carotid artery. When cold is applied to the skin, the capillaries of the body respond to contraction, whereas the larger blood vessels of the body exhibit an expansion response, which promotes the circulation of the cooled blood from the carotid artery to the brain. It is.

  This protocol includes the determination of the size of the collar 10 required for the patient. Available sizes include conventional no neck, short size, regular size, and tall size cervical fixation collars. After the collar 10 is attached to the patient, the door 30 is opened. Next, the package filled with the liquid is broken, and the cooling member 52 is activated by shaking the cooling member 52 for about 15 to 20 seconds. And the cooling member 52 is arrange | positioned in the front opening part 28 of the flame | frame of the cyclic | annular support structure 12, and it abuts on a patient's neck by closing the door 30. FIG. The cooling member 52 is in a state of percutaneous heat transfer with at least one of the patient's carotid arteries through the anterior portion of the patient's neck so that the anterior portion of the patient's neck is routed from one or more carotid arteries. Thus, heat begins to be transmitted to the cooling member, thereby lowering the temperature of the patient's brain without causing systemic hypothermia.

  The cooling member 52 preferably remains in place for approximately 20 minutes and within 30 minutes, at which time the first cooling member is removed and a new cooling member is activated to activate the new cooling member within the collar as described above. It is good to arrange in. Repeat this protocol if necessary.

  In addition, the protocol may include monitoring one or more parameters related to the patient's blood circulation behavior, communicated by the fixed collar via one or more sensors. Monitoring parameters may include oxygen saturation, pulse rate, blood pressure, or blood temperature. In addition, sensors may be utilized to monitor the temperature performance of the cooling member. Moreover, the protocol claims include manually moving the cooling member from the collar opening over the patient's carotid triangle to another location and manually measuring the patient's pulse rate. .

  Although the invention has been described with reference to limited embodiments, many variations will be readily apparent to those skilled in the art according to the general teachings and scope of the invention. For example, cooling members may be placed on both the anterior and posterior portions of the cervical fixation collar to extract heat from a wider area of the patient's neck. Although cooling of the carotid arteries on both sides is generally preferred, the cooling member may be made so that the other carotid artery is exposed and the one carotid artery is cooled for other uses.

  10: Cervical spine fixation collar, 12: annular support structure, 20, 38: hook and loop strap, 26: cheek support structure, 28: front opening, 30: door, 32: hinge, 52: cooling member, 54: Body side panel, 56: compression member, 58: foam layer

Claims (16)

A cooling member,
A body side panel attached on the side of the body;
An outer panel forming an end with the body side panel;
A coolant disposed between the body side panel and the outer panel;
The coolant provides a temperature of 20 ° F. to 35 ° F. within 1 minute after activation, as measured on the side of the body side panel;
The cooling member, wherein the coolant includes water, urea, and an endothermic material.   The cooling member according to claim 1, wherein the coolant can maintain the temperature for 15 minutes to 30 minutes.   The cooling member according to claim 1, wherein the endothermic material is Carbamaool (registered trademark).   The cooling member according to claim 3, wherein the coolant includes 90 to 110 grams of urea and 45 to 55 grams of Carbamaool®.   The cooling member according to claim 4, wherein the coolant includes 100 grams of urea and 50 grams of Carbamaool®.   The cooling member according to claim 4, wherein the coolant comprises 110 grams of urea and 55 grams of Carbamaool®.   The body side panel has a lining made of a non-woven material attached to a body side surface, and the lining covers the body side surface of the body side panel and an outer side surface of the outer panel. The cooling member according to 1.   The cooling member according to claim 7, wherein the lining is attached to the body side panel.   The cooling member according to claim 1, further comprising a neck band attached to the end portion and formed to wrap around a patient's neck.   The cooling member according to claim 9, wherein the neck band includes a wing extending from an end formed by the body side panel and the outer panel.   The cooling member according to claim 10, wherein the wing portion includes an attachment mechanism.   The cooling member according to claim 11, wherein the attachment mechanism is a hook-and-loop fastener. The body side panel and the outer panel define a second end;
The neck band includes a first wing extending from the end and a second wing extending from the second end;
The cooling member according to claim 9, wherein the first and second wing parts are attached to each other.   The cooling member according to claim 1, wherein the coolant contains a larger amount of urea by mass than the endothermic material.   The cooling member according to claim 1, wherein the coolant includes at least 45 grams of the endothermic material. 2. The cooling member according to claim 1, further comprising temperature measuring means for monitoring the temperature of the cooling member.

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