First responder device

A first responder device for treating blood flow from a deep wound or a bodily cavity having an inflatable balloon, a first chamber accommodating a liquid arranged for inflating the balloon, a second chamber accommodating a cooling agent capable of dissolving in the liquid when coming in contact therewith, thereby lowering the temperature, a rupturable seal between the first and second chambers, and a structure for forcing the liquid out of the first chamber into the inflatable balloon, and for rupturing the rupturable seal.

The present invention relates to a First Responder device for tamponading deep wounds, in particular (non-superficial) bullet wounds and stabbing wounds, or bleeding from body cavities, in particular, but not exclusively, bleeding noses.

TECHNICAL FIELD

From a medical perspective, bleeding from deep wounds is problematic and even dangerous, for several reasons: Among these, one is the difficulty to stop the loss of blood pressure, which may quickly lead to an ultimately fatal hypovolemic shock. Another, seemingly less immediate issue is the potential entry of harmful bacteria (or fungi, viruses, or toxins) into the wound, which bacteria (or fungi, viruses, or toxins, respectively) may cause an equally fatal septic shock with a few hours or days; and also the pain resulting from the injury.

BACKGROUND ART

A system for purging deep wounds is known from EP 0 959 936 B1, but this system is intended for the after-treatment of wounds, and is not practically useful for First Responders and paramedics. Known simple tamponades are on some occasions not considered adequate.

There is therefore still a need for providing First Responders with an adequate tool for dealing with this sort of injury, or condition, as the case may be.

SUMMARY OF THE INVENTION

To address this need, the invention provides a device for insertion into the wound or body cavity, as the case may be; whereupon the First Responder inflates a balloon inserted into the wound with a liquid comprising a cooling agent. Simultaneously, a wound cover may be expanded around the device and wound, ideally directly on the surrounding skin. Under another aspect, the invention provides a method of treating deep wounds, or bleedings from body cavities, respectively, using a cooling agent.

The expanded balloon firstly serves to seal any ruptured blood vessels by its mere presence. Secondly, the liquid containing the cooling agent, e.g. water in which a suitable agent dissolves in the process of expanding the balloon, exerts an astringent stimulus on such blood vessels. Both effects reduce the loss of blood pressure for a period of time sufficient for more professional medical help to come within reach.

In further embodiments, the outer surface of the balloon is pre-impregnated with agents assisting in the astringent action, and/or agents such as anti-bacterial agents helping in avoiding the often serious effects of a septic shock. Other medicaments may also be included, such as medicaments stabilizing vital body functions, and/or analgesics, and/or medicaments having an astringent effect.

The cooling agent is, in some embodiments, kept separate from the liquid used to inflate the balloon, in a separate chamber. When the device is actuated by the First Responder, the liquid is brought in contact with the cooling agent, which dissolves in the liquid and thereby cools down. In the process, the cooling solution inflates the balloon until same contacts the surrounding tissue sufficiently tightly for the blood to stop or to be markedly reduced. At the same time, an aseptic wound cover is expanded on the skin surface so as to bar later entry of dirt, bacteria and the like into the wound. The same effects are achieved if the blood flow comes from a bodily cavity such as the nose, vagina, or anus, rather than a bullet wound. Naturally, the device can be made in various sizes to address a variety of potential situations.

In an embodiment, a syringe as part of the device has two compartments, the proximal one of which accommodates water and the distal one of which accommodates the cooling agent. Capillary ducts enable the water to enter the second compartments only when the plunger is actuated. Once the plunger reaches the temporary wall separating the two compartments, it dislocates the temporary wall distally from its original position. Only further movement of the plunger urges the solution into the balloon and inflates it to the desired pressure.

The structure of the mechanism for expanding the wound cover is not particularly limited, as long as it keeps the cover closely attached to the elongated device until use, in an aseptic state. The structure may e.g. be pre-tensioned in an umbrella-like shape around the connection of the balloon and the lumen holding the liquid. When the liquid is pressed into the balloon, such as with a plunger, the aseptic seal is broken and the wound cover expands. After the balloon has been fully expanded, the lumen is removed from the balloon, so that the surface of the injured site is essentially flat and the surroundings covered by the expanded wound cover. This makes it easier to apply additional dressing to the wound, or padding to the bodily cavity, respectively, if required. In some embodiments, a valve is automatically closed at the same time.

In some embodiments, the balloon has an inflated shape (at a given pressure of, e.g., 1.5 bar) which is elongated, i.e. its length exceeds six times its maximum diameter.

In some embodiments, the balloon is covered with oxidized regenerated cellulose (ORC) for enhancing the hemostatic effect.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

In the embodiment according toFIG.1, the device9comprises a body portion7having a cylindrical wall11, accommodating water in its section below (proximal to) the septum21, and a wound cover27(shown only schematically) arranged around the body7. In its section above (distally of) the septum21, the body7accommodates a cooling agent29, e.g. solid urea. The urea (or other cooling agent) may be provided in a water soluble, or water penetrable (e.g. porous) baglet.

A plunger23, actuated via a plunger rod25, defines a lumen of the shaft, wherein the plunger may be moved in the lengthwise direction indicated by the double-tipped arrow; i.e., inwardly (upward inFIG.1) when activating the device, and outwardly (downward inFIG.1) before removing the device from the wound after use. At the tip of the device30, a soft cone (or frusto-cone, or part-ovoid)33of absorbing material is attached, for aid in guiding the device9into a deep wound, or into a body cavity, and also for providing additional absorbing capacity. Although not shown in this Figure for simplicity, the balloon26is also covered with an absorbing material such as oxidized regenerated cellulose, impregnated with agents such as e.g. adrenalin (epinephrine), broadband antibiotics such as e.g. tedizolid or oritavancin, and/or an analgesic such as e.g. buprenorphine.

In the embodiment shown, the device's body7is contiguous with a balloon section5arranged distally of the body7, which balloon section comprises the inflatable balloon26. On the right hand side ofFIG.1, the balloon is shown in its normal, non-inflated state26′; whereas on the left-hand side ofFIG.1, the balloon is shown in its inflated state26″.

The temporary septum21provides a first chamber inside the body7, accommodating the water, and a second chamber, accommodating the cooling agent. The septum21is held in place by distal protrusions13′,13″ formed on the inner surface of the wall and slope. Capillary ducts15(15ainFIG.1a) are formed around (or between) the distal protrusions13″, so that when the plunger urges the septum21against the distal protrusions13″, water is pressed around the septum21into the distal chamber7″, thereby coming into contact with the cooling agent29. When the plunger23reaches the septum21, it dislocates same from its original position between the protrusions13, and the solution meanwhile formed in the second chamber is urged through the valve19into the balloon section5. Openings28are formed therein, for allowing the inflating, cool fluid to pass there through, and ultimately to exert a pressure on the balloon26from the inside thereof. The protrusions13′,13″ may be several (3-6), nose-like ones arranged around the perimeter; or each may be one annular protrusion, preferably resilient. Naturally, there may also be e.g. two or three part-annular protrusions on the same perimeter circle.

FIG.1aschematically shows a variant of this structure (where appropriate, reference numerals have an “a” added): According to this example, the septum and protrusions are replaced by a second plunger-head21a, which is held in place by plural O-rings43until coming into contact with the actual plunger23a. In a first stage, actuation of the plunger (indicated by the big arrow) presses the solvent through capillary ducts15a, which are arranged around the second plunger-head21a, from the first chamber7a′ into the second chamber7a″ (arrow “I”), to dissolve the cooling agent placed there in a small water-dissolvable or water-penetratable bag29a. Meanwhile, any air present in the second chamber7a″ enters into the balloon (not shown in this drawing). When the actual plunger23acomes into contact with the second plunger-head21a, with some additional force the second plunger-head21ais displaced (arrow “II”) from its original position towards the exit valve (also not shown in this drawing). In that second stage, the pre-cooled solution in the second chamber is pressed into the balloon as well. The actual plunger23ain this example likewise has plural O-rings43as a seal against the environment. The capillary ducts15amay be equally spaced around the original position of the perimeter of the second plunger-head21a.

Usually, around 10 to 40 ml or even only 10 to 15 ml will be sufficient to inflate the balloon26. For certain less deep wounds or cavities, such as bleeding from noses, less than that may be required; accordingly, a suitable volume of the lumen will generally be between 1 ml and 40 ml, preferably between 1 ml and 25 ml. In typical cases, the length of the balloon section will be more than 6 times its diameter.

Although not shown in detail, a connector arrangement may be provided at the distal end of the shaft, in order to assemble the body to the balloon section5described above. In this case, the septum17may comprise two septa in succession, wherein one septum forms part of the body section7(or syringe) and the other septum forms part of the balloon section5, for sealing the balloon26until use. The connector assembly may consist of a male thread on the shaft part, and a matching female thread on the balloon part, or vice versa. It is envisaged to provide the various parts of the device, at least the shaft part including the plunger and the balloon part, as separate entities, which are assembled only immediately before use. The fluid may be provided in the shaft/plunger part, such as a syringe. It is envisaged to provide the cooling agent separately, but within the device body. The dissolved cooling agent is then introduced into the balloon part, inflating the balloon. Thereafter, the plunger part may be removed; to this end, it is envisioned that a valve19is provided, which closes automatically when the plunger part is removed. In this manner, the site remains flat, and may be covered.

In operation, the device is inserted into the wound or body cavity, such that the balloon section5is inside the wound or body cavity, respectively. At this stage, the balloon26′ is not yet inflated. It may be noted that the length of the device's balloon section5may by far exceed the diameter. In some applications, the length is about 10 to 15 cm; generally, it will usually be in the range 6 to 25 cm, while the inflated diameter is about 1 cm (if the device is not inserted into a wound—naturally, otherwise the balloon will assume a diameter to the extent the surrounding tissue allows). In this regard, the inflated diameter and length are to be measured at an inflation pressure of e.g. 1.5 bar. The balloon section, and in particular its tip section30, allows inserting the device9into a deep wound by providing some stiffness, while the balloon26is not yet inflated.

After insertion, the plunger23is displaced inwardly so as to urge the fluid contained in the first chamber around the septum21and into the second chamber (which in this embodiment accommodates the cooling agent29). When the plunger is moved farther, the fluid exits also the second chamber through septum17, into the balloon section5, and through the openings28and thereby inflates the balloon26″. The balloon in this manner exerts some gentle pressure on the inside of the wound wall, helping to control bleeding. At the same time, the balloon seals the wound to prevent entry of dirt or the like. Any blood oozing out around the balloon26will be absorbed by the wound cover27expanded around the body7when the device is operated. It is conceivable to provide an astringent agent and/or other helpful agents, such as an anti-biotic agent, an analgesic, or an agent stabilizing circulation, on the outer surface of the balloon. The outer surface of the balloon can be covered with oxidized regenerated cellulose. Any medicaments may be impregnated thereon.FIG.3schematically shows how the device is arranged relative to the body under the inventive First Responder treatment.

In order for the cooling agent29to perform its function, it should have a positive enthalpy of solution in the fluid, i.e., under normal conditions and constant pressure, the dissolving shall readily take place, but shall require input of energy into the solution. The required energy will be provided by the thermal energy of the solvent and solute. The process will thus lead to internal cooling of the solution and therefore of the balloon26as a whole. Via the thin envelope of the balloon26, the inside of the wound or body cavity will likewise be cooled, and bleeding will be slowed or stopped.

It may be estimated that an enthalpy of dissolution of more than 10 kJ/mol may be required to achieve sufficient cooling. Herein, it is assumed that an amount of between 1 g and 20 g of the cooling agent29may be suitably accommodated in the chamber. A suitable example is urea, which undergoes considerable cooling when coming into contact with water, in which it is well soluble. Another example is ammonium nitrate, or calcium chloride hexahydrate.

The structure employed in this example for expanding the wound cover27is shown schematically inFIGS.2a-c(in which the dash-dotted line indicates the longitudinal central axis of the shaft section7): The structure comprises a plurality of three or more radial struts34, which in the compressed state extend lengthwise on the device9, such as around the cavities holding the water and the cooling agent. Already in this state, the radial struts34are accommodated in pockets in the wound cover27made e.g. of oxidized cellulose. In addition, there are expansion struts36pivotably connected32to the radial struts34about halfway of the length of the radial struts34. The expansion struts36, at their distal end, are pivotably connected24to the device at the proximal end of the balloon section. The proximal ends of the radial struts34are pivotably connected to a common annular structure22, such as a ring or polygon. This structure22may, but need not be fastened to the plunger rod25. When the plunger rod25is actuated, or independently, the annular structure22presses down the top ends of the radial struts34. Same being linked to the expansion struts36, which in turn are supported by the fixations24, the distal ends of the radial struts34move outward (seeFIG.2b), thereby gradually expanding the wound cover27. The lengths of the struts34,36and the position of the link32therebetween are adjusted so that when the annular structure22moves downward, the distal ends of the radial struts34move outward, from the site of the wound or body cavity, closely above the patient's skin. When the expanding motion is completed, the wound cover27is essentially planar and covers the periphery of the wound or body cavity, aiding in protecting the site from the ingress of dirt and the like, and at the same time aiding in absorbing any blood oozing out around the tamponade. The expansion struts36are preferably made as flat as possible. The joining may be made so as to pre-tension the expansion struts36outwards. The radial struts34are made sufficiently rigid to enable, e.g., pushing the outer peripheral rim of the wound cover27underneath any clothing present. The number of struts34,36is not particularly limited, but four to eight are preferred. The entire structure including the wound cover27, until use, is accommodated in an aseptic cover31, which is broken only immediately before use.

FIG.2cshows a top view (i.e., towards the patient) of a partially expanded structure: The radial struts34are expanding the wound cover27, in pouches38of which (indicated by the dashed lines) they are accommodated. The linking of the radial struts34to the annular structure22(hexagonal in this example, for supporting six radial struts34) is not shown in detail for simplicity. Depending on the elasticity of the wound cover material27, there may in this state be pleats which are also not shown.

In a variant not shown, the expansion struts are not connected to the radial struts, but their outer sections are accommodated in pouches of the wound cover together with the radial struts, or in separate pouches; e.g., alternating with the pouches for the radial struts. Before use, the expansion struts are bent in a U-shape, with their outer parts extending in an opposite direction to the inner parts. When the struts are released, and/or the annular structure holding the radial struts is moved distally, the U-bent expansion struts thus help expanding the wound cover by their inherent tendency to straighten. Naturally, the outer sections of the U-bent expansion struts may also be connected to the outer parts of the radial struts, in particular if the wound cover is rather fragile.

While the invention has been described above in the context of specific embodiments, the skilled person will become aware of various suitable modifications and variations. The above description accordingly shall not be construed as limiting for the invention, which is defined by the appended claims only. More generally, the present application discloses an emergency medical device for the prophylactic or therapeutic manage-ment of hypovolemic shock, sepsis, and even pain by means of an inflatable part, in particular a balloon connected to a source of a self-cooling liquid or mixture. In other aspects, the present application discloses a method of emergency medical treatment of patients suffering from, or being threatened with, hypovolemic shock, e.g. through severe hemorrhaging, by means of inserting an inflatable device into a natural or non-natural body cavity, the device in particular having inherent cooling means.

In some variants, the First Responder device further comprises a holder60mounted laterally of the shaft, for keeping the device sterile until use. This holder may have a corrugated grip part for better grip, in particular if the First Responder wears gloves. The First Responder device may further include a rotatably operable lock50between the shaft section and/or the balloon section. It may further comprise a first cap71accommodating the balloon section and/or a second cap72accommodating the shaft section, for safer stowing the device away until use. The device may includes a hollow cylinder and a plunger movable lengthwise of the hollow cylinder, e.g., accommodated in the second cap until use. In this case, the plunger before use of the First Responder device can be accommodated beside the hollow cylinder, to be inserted into a proximal end of the hollow cylinder only for use of the device, in order to reduce the length of the stowed-away device. In some variants, the First Responder device further comprises structure41for providing a valve42between the deep wound or body cavity, and the outside, the valve capable of allowing air flow out of, but not into the deep wound or body cavity, so as to be capable of being used when there is a pneumothorax or danger thereof. The valve may in this case be made of a silicone. The balloon may likewise be made of a silicone. It may, e.g., be about 10 to 13 cm in length, and the thickness of the silicone may be in the range 0.1 to 0.3 mm, so as to be inflatable to about 25 to 40 cm3in volume.