A tamponade for treating penetrating wounds

EP4761644A1Pending Publication Date: 2026-06-24ACT MEDICAL LTD

Patent Information

Authority / Receiving Office
EP · EP
Patent Type
Applications
Current Assignee / Owner
ACT MEDICAL LTD
Filing Date
2024-08-15
Publication Date
2026-06-24

AI Technical Summary

Technical Problem

Current methods for managing blood loss from penetrating wounds, such as stab and gunshot wounds, are inadequate for immediate and effective control, often leading to fatal outcomes.

Method used

An expandable tamponade system comprising a balloon, guide, and handle, which can be inserted into a penetrating wound and inflated using a fluid supply to apply pressure and control bleeding.

Benefits of technology

The expandable tamponade effectively reduces blood loss from penetrating wounds by providing adjustable and configurable pressure, is easy to use and compact for first responders, and can be easily deflated and removed when the patient reaches definitive care.

✦ Generated by Eureka AI based on patent content.

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Abstract

Broadly speaking, embodiments of the present techniques provide an expandable tamponade for treating penetrating wounds. Advantageously, the present techniques provide an expandable tamponade comprising a balloon, wherein the balloon can be inflated to provide pressure onto the wound when the tamponade has been inserted into the wound. The tamponade further comprises a guide and handle for inserting the balloon into the wound, and a coupling means for coupling the balloon to a fluid supply for inflating the balloon.
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Description

[0001] A Tamponade for Treating Penetrating Wounds

[0002] Field

[0003] The present application generally relates to a tamponade for treating penetrating wounds, such as stab and gunshot wounds. In particular, the present techniques relate to an expandable tamponade comprising a balloon for providing pressure to a penetrating wound.

[0004] Background

[0005] Blood loss from penetrating wounds, such as stab and gunshot wounds, can be fatal. A system that enables first responders to reduce the blood loss from such wounds could save many lives.

[0006] The present applicant has identified the need for an improved mechanism for reducing blood loss from penetrating wounds.

[0007] Summary

[0008] In a first approach of the present techniques, there is provided an expandable tamponade for treating penetrating wounds, comprising: a balloon; a guide for guiding the balloon into a wound tract; a handle connected to the guide, for inserting the balloon and guide into the wound tract; and a coupling means for coupling the balloon to a fluid supply to expand the balloon inside the wound tract.

[0009] The expandable tamponade of the present techniques may be suitable for use in any penetrating wound, such as a stab wound, a bullet wound, or any other type of open wound, for example, a wound caused by shrapnel from an explosive device. Thus, it will be understood that the present techniques are not limited to any specific type of wound. The term “penetrating wound” is used interchangeably herein with the terms “wound”, “stab wound” and “bullet wound”.

[0010] The expandable tamponade of the present techniques has multiple advantages. For example, the expandable tamponade is easy to use and compact, making it suitable for first- responders (e.g. paramedics) and soldiers to carry with them and to use. Being able to inflate or expand the balloon of the tamponade when it is inside a wound means that the tamponade is configurable / adjustable as the balloon can be inserted deep enough to match the wound depth, and inflated to the right amount to suit each wound. Moreover, as the tamponade is expandable, it can easily be deflated and removed when the patient has reached definitive care, such as a hospital.

[0011] The guide enables insertion of the balloon into the wound. This is particularly advantageous as the balloon may be made from a flexible material which may be difficult to fully insert into the wound. The guide then provides stability to the balloon such that the balloon can be inserted fully into the wound.

[0012] The guide may be provided within the balloon. That is, the balloon may encase the guide and inflate around the guide. The guide may then be used to push the balloon into a wound. The guide may be deformable or flexible. The guide being deformable or flexible allows flexibility to navigate a wound tract. Consequently, the balloon may be inserted fully into the wound while adapting to any particular wound tract geometry such that the balloon applies pressure on the whole wound tract. Additionally, the guide may be deformed to a shape of the penetrating wound before inserting the balloon and guide into the wound.

[0013] The length of the guide may be varied. That is, the length of the guide may be adapted to the length of the wound tract, and may be made longer or shorter, as required. Thus, the guide may be a variable length guide.

[0014] The tamponade may comprise a telescopic extension mechanism having an external tube, and an internal portion provided by the variable length guide, the internal portion being slidable within the external tube.

[0015] In some cases, the handle may comprise the external tube of the telescopic extension mechanism and the external tube may be provided within the balloon. Alternatively, the handle may comprise the variable length guide and the external tube may be provided within the balloon. In both of these cases, the external tube may be fully or partially inserted into a wound tract. The external tube may define the shortest length of the tamponade, and in this case, the variable length guide may not extend from the external tube. In other cases, a portion of the variable length guide may always extend out of the external tube, such that this portion and the length of the external tube define the shortest length of the tamponade. The variable length guide may slide and extend out of the external tube into the balloon to increase the length of the tamponade.

[0016] Alternatively, the handle may comprise the external tube of the telescopic extension mechanism and the external tube may be slidable along a length / portion of the balloon and variable length guide. In this case, the external tube is not inserted into a wound tract. Instead, the balloon and variable length guide are able to slide through the external tube to adjust the length of the balloon and variable length guide that are inserted / to be inserted into a wound tract. The external tube may also prevent the portion of the balloon that is not within a wound tract to not be inflated, or not be completely inflated. The variable length guide may comprise a locking mechanism for locking the variable length guide in an extended or an unextended position. This allows the guide to remain fully extended when inserting the balloon into the wound. That is, while the guide may be adjustable in length, the guide can be locked such that it is not adjustable during insertion and provides enough stability to insert the balloon and guide fully into the wound. Preferably, the guide is locked in a fully extended position during insertion of the guide and the balloon, and then unlocked to adjust the length of the guide to the wound. The locking mechanism may be engaged by turning a key. Thus, the guide may be made adjustable by turning a key to lock and / or unlock the adjustability of the guide. The key may be located at the handle of the probe such that the key is easily accessible by a user, even when the balloon and guide have been fully inserted into the wound.

[0017] Thus far, examples where the guide is provided within the balloon have been discussed. In another example, the guide may comprise a removable housing, and the balloon may be provided within the guide. That is, instead of being placed inside the balloon, the guide may surround the balloon and provide some protection to the balloon when the balloon is being inserted into the wound. This can be advantageous, for example, when the wound was caused by shrapnel that remains inside the wound and could damage the balloon. This may also be advantageous, as the balloon is generally protected before and during insertion of the balloon and guide into the wound.

[0018] The housing may be a tube, and the housing may be removable by sliding the tube along the balloon towards the handle. That is, the balloon may be placed inside the tube that is open at least one end. The housing may then be removed by pulling the tube towards the handle and out of the wound. After the housing is removed, the balloon can be inflated. Advantageously, removing the housing may remove the number of rigid parts inside a patient’s wound. This in turn reduces a risk of damage caused by these rigid parts during transport of the patient.

[0019] The tamponade may further comprise a one-way clutch for retaining the balloon inside the wound when the housing is removed. This means that the balloon is maintained inside the wound, even when there is friction between the housing and the balloon when the housing is removed after insertion of the housing and the balloon into the wound.

[0020] The tamponade may further comprise a restraint for preventing a portion of the balloon outside the wound from inflating when the tamponade has been inserted into the wound. This is desirable as inflation of the balloon outside the wound may make the balloon less effective at delivering pressure to the wound to stem any bleeding. When it is not possible to insert the whole of the balloon into the wound, the restraint may therefore be used to prevent inflation of the balloon outside the wound. The restraint may be a tube or mesh or any other suitable material and shape. The restraint may be slidably placed around the balloon to adjust a position of the restraint around the portion of the balloon outside the wound. That is, the restraint may be moved around the balloon during insertion of the balloon and guide into the wound to ensure that only the portion of the balloon inside the wound inflates. The restraint may be attached to the handle, and the restraint and handle may be slidably placed around the balloon to allow the handle to be positioned to contact an opening of the wound when the balloon has been inserted into the wound. For example, the balloon and guide may be inserted into the wound. When the balloon and guide have been inserted into the wound, the handle and restraint may then be moved towards the wound such that the handle contacts the wound opening. Advantageously, in this configuration it may be easier to move the restraint into a position suitable for preventing inflation of the balloon outside the wound. The handle may also seal the wound and protect the wound from any further dirt or debris. The restraint may flexible or rigid. For example, the restraint may be a mesh. The restraint may have a tubular shape. For example, the restraint tube may have a diameter similar to the diameter of the uninflated balloon to effectively prevent inflation of the balloon outside the wound.

[0021] The tamponade may further comprise a rigid locator tip for guiding the balloon through the wound. The rigid locator tip may be the first part of the tamponade to be inserted into the wound, and thus may be shaped to ease the tamponade into the wound as well as through the wound. For example, the rigid locator tip can push through the tissue and musculature of / around the wound. The rigid locator tip may be attached to an exterior or interior portion of the balloon that first enters the wound. Alternatively, the rigid locator tip may be attached to an end of the support member first entering the wound.

[0022] The tamponade may further comprise a fastening mechanism for fastening the tamponade to a patient. In some cases, the fastening may be coupled to the handle. For example, the handle may comprise a hilt or similar component which may be in close proximity or in contact with a wound opening, and the fastening may be coupled to the hilt.

[0023] The fastening mechanism may comprise one or more of: a strap for strapping the tamponade in position on the patient; at least one hook for insertion into skin of the patient; a strap and at least one hook for insertion into skin of the patient; and adhesive for adhering the tamponade to skin of the patient.

[0024] The balloon may comprise a retention mechanism on an external surface of the housing for retaining the tamponade within a wound tract. For example, the retention mechanism may comprise bristles or Velcro (RTM) or similar components which grip and / or increase friction, thereby making it more difficult for the tamponade to slip out of the wound tract. In a second approach to the present techniques, there is provided a first responder kit for treating penetrating wounds, the kit comprising: the tamponade of the types described herein; and a fluid supply couplable to the coupling means, for expanding the balloon of the tamponade inside a wound tract.

[0025] The kit may further comprise: a mechanism for maintaining a pressure inside the balloon less than or equal to a predefined pressure value.

[0026] When the fluid is air, it may be easy to inflate the tamponade in the field, as no special equipment is needed to inflate the balloon. When the fluid is air, the mechanism for maintaining a pressure may be an excess pressure valve.

[0027] When the fluid is saline, the mechanism for maintaining a pressure may be a mechanism for pneumatically maintaining a fluid pressure inside the balloon below a predetermined fluid pressure value.

[0028] In each case, the valve may ensure that a pressure on the wound tissue provided by the balloon remains within safe limits while being effective at stemming any bleeding.

[0029] The features described above with respect to the first approach apply equally to the second approach and therefore, for the sake of conciseness, are not repeated.

[0030] Brief description of the drawings

[0031] Implementations of the present techniques will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0032] Figures 1A to 1C shows one embodiment of an expandable tamponade;

[0033] Figures 2A to 2C show a further embodiment of the expandable tamponade comprising a variable length guide;

[0034] Figures 3A and 3B show the embodiment of the expandable tamponade comprising a variable length guide, wherein the variable length guide 402 comprises a locking mechanism for locking the variable length guide in an extended or an unextended position;

[0035] Figures 4A to 4D show an embodiment of the expandable tamponade in which the guide may comprise a removable housing, and the balloon may be provided within the guide;

[0036] Figure 5 shows a fastening mechanism for fastening the tamponade to the patient, the fastening mechanism comprising a strap for strapping the tamponade in position on the patient;

[0037] Figure 6A shows a fastening mechanism for fastening the tamponade to the patient, the fastening mechanism comprising at least one hook for insertion into skin of the patient; Figure 6B shows the fastening mechanism of Figure 6A when the at least one skin hook is further attached to a strap;

[0038] Figure 7A shows a fastening mechanism for fastening the tamponade to a patient, the fastening mechanism comprising an adhesive strip for adhering the tamponade to the skin of the patient;

[0039] Figure 7B shows fastening mechanism for fastening the tamponade to a patient, the fastening mechanism comprising an adhesive blister for adhering the tamponade to the skin of the patient;

[0040] Figure 7C shows the fastening mechanism of Figure 7B when the adhesive is further attached to a strap;

[0041] Figure 8 shows a bristle internal retention mechanism;

[0042] Figure 9 shows a Velcro (RTM) internal retention mechanism;

[0043] Figure 10 shows a clip fastening mechanism;

[0044] Figure 11 shows a treasury tag fastening mechanism; and

[0045] Figure 12 shows different types of fluid supply of a first responder kit for treating penetrating wounds.

[0046] Detailed description of the drawings

[0047] Broadly speaking, embodiments of the present techniques provide an expandable tamponade for treating penetrating wounds. Advantageously, the present techniques provide an expandable tamponade comprising a balloon, wherein the balloon can be inflated to provide pressure onto the wound when the tamponade has been inserted into the wound. The tamponade further comprises a guide and handle for inserting the balloon into the wound, and a coupling means for coupling the balloon to a fluid supply for inflating the balloon.

[0048] Figures 1A to 1C shows one embodiment of an expandable tamponade 100. The expandable tamponade for treating penetrating wounds, comprises: a balloon 104; a guide 102 for guiding the balloon into a wound tract; a handle 106 connected to the guide, for inserting the balloon and guide into the wound tract; and a coupling means 110 for coupling the balloon to a fluid supply 200 to expand the balloon inside the wound tract.

[0049] The expandable tamponade of the present techniques may be suitable for use in any penetrating wound, such as a stab wound, a bullet wound, or any other type of open wound, for example, a wound caused by shrapnel from an explosive device. Thus, it will be understood that the present techniques are not limited to any specific type of wound. The term “penetrating wound” is used interchangeably herein with the terms “wound”, “stab wound” and “bullet wound”. The expandable tamponade of the present techniques has multiple advantages. For example, the expandable tamponade is easy to use and compact, making it suitable for first- responders (e.g. paramedics) and soldiers to carry with them and to use. Being able to inflate or expand the balloon of the tamponade when it is inside a wound means that the tamponade is configurable / adjustable as the balloon can be inserted deep enough to match the wound depth, and inflated to the right amount to suit each wound.

[0050] The guide 102 enables insertion of the balloon into the wound. This is particularly advantageous as the balloon 104 may be made from a flexible material which may be difficult to fully insert into the wound. The guide then provides stability to the balloon such that the balloon can be inserted fully into the wound.

[0051] The guide may be provided within the balloon. This is shown in Figures 1A to 1C. That is, the balloon may encase the guide and inflate around the guide 102. The guide may then be used to push the balloon into a wound. The guide 102 may be deformable. The guide being deformable allows flexibility to navigate a wound tract. Consequently, the balloon may be inserted fully into the wound while adapting to any particular wound tract geometry such that the balloon applies pressure on the whole wound tract. Additionally, the guide may be deformed to a shape of the penetrating wound before inserting the balloon and guide into the wound. A deformable guide may be advantageous because wounds may not be completely straight or linear - the deformability may enable the balloon to be situated within the wound better. A deformable guide may help navigate the wound track. A deformable guide may be stiffer than the material used for the balloon 104 of the expandable tamponade but flexible enough to conform to the shape of the wound track, which is helpful for wounds that are not perpendicular to the surface of the body part where the wound exists. The deformable guide 104 may be a wire. Figures 1A to 1C show a guide that is a wire. The wire may be bent and both ends of the wire may be fixed to the handle, such that the end of the wire that first enters the wound is a bent rounded end of the wire, as shown in Figures 1 A to 1C.

[0052] The length of the guide 102 may be varied. That is, the length of the guide 102 may be adapted to the length of the wound tract, and may be made longer or shorter, as required. Thus, the guide may be a variable length guide.

[0053] The tamponade may comprise a telescopic extension mechanism having an external tube, and an internal portion provided by the variable length guide, the internal portion being slidable within the external tube. The handle 106 may comprise the external tube of the telescopic extension mechanism and the external tube may be slidable along a length / portion of the balloon and variable length guide. In this case, the external tube is not inserted into a wound tract. Instead, the balloon and variable length guide are able to slide through the external tube to adjust the length of the balloon and variable length guide that are inserted / to be inserted into a wound tract. The external tube may also prevent the portion of the balloon that is not within a wound tract to not be inflated, or not be completely inflated.

[0054] Figures 2A to 2C show a further embodiment of the expandable tamponade 300 comprising a variable length guide 302. The length of the guide may be varied. That is, the length of the guide may be adapted to the length of the wound tract, and may be made longer or shorter, as required. Thus, the guide may be a variable length guide. That is, the length of the guide may be adapted to the length of the wound tract, such that the whole of the guide and the balloon fit inside the wound tract.

[0055] The tamponade may comprise a telescopic extension mechanism having an external tube, and an internal portion provided by the variable length guide, the internal portion being slidable within the external tube. In the embodiments shown in Figures 2A to 2C, the handle may comprise the variable length guide and the external tube may be provided within the balloon. In this case, the external tube may be fully or partially inserted into a wound tract. The external tube may define the shortest length of the tamponade, and in this case, the variable length guide may not extend from the external tube. In other cases, a portion of the variable length guide may always extend out of the external tube, such that this portion and the length of the external tube define the shortest length of the tamponade. The variable length guide may slide and extend out of the external tube towards the handle inside the balloon to increase the length of the tamponade.

[0056] That is, in the embodiments shown in Figures 2A to 2C, an external tube is provided within the balloon. The external tube is connected to the variable length guide via a slidable connection mechanism. The external tube may not be connected to the variable length guide by any other means, i.e. the external tube may not be connected to the balloon. In this case, the slidable connection mechanism may have a catch to prevent the external tube from disconnecting from the variable length guide. The catch may ensure that the external tube and the variable length guide remain connected, even when the external tube is allowed to slide freely along the variable length guide.

[0057] Figure 2A shows a fully extended variable length guide, whereas Figure 2B shows the variable length guide 302’ shortening. When the balloon and guide are inserted into the wound, the variable length guide may be fully extended, and before inflating the balloon a length of the variable length guide may be adjusted to match a length of the wound.

[0058] Figures 3A and 3B show the embodiment of the expandable tamponade comprising a variable length guide 402, wherein the variable length guide 402 comprises a locking mechanism for locking the variable length guide in an extended or an unextended position. In the embodiments shown in Figures 3A and 3B, the handle may comprise the external tube of the telescopic extension mechanism and the external tube may be provided within the balloon. In this case, the external tube may be fully or partially inserted into a wound tract. The external tube may define the shortest length of the tamponade, and in this case, the variable length guide may not extend from the external tube. In other cases, a portion of the variable length guide may always extend out of the external tube, such that this portion and the length of the external tube define the shortest length of the tamponade. The variable length guide may slide and extend out of the external tube into the balloon to increase the length of the tamponade.

[0059] This allows the guide to remain fully extended when inserting the balloon into the wound. That is, while the guide may be adjustable in length, the guide can be locked such that it is not adjustable during insertion and provides enough stability to insert the balloon and guide fully into the wound. The locking mechanism may be engaged by turning a key 412, as shown in Figures 3A and 3B. In Figure 3A, the variable length guide is locked in an extended position and thus provides rigidity for the balloon for inserting the balloon and guide into the wound. In Figure 3B, the key 412 is turned and the variable length guide is unlocked. This unlocked position of the guide may be suitable for sealing the balloon 404’ and guide inside the wound as it allows the length of the guide 402’ to be adjusted to a length of the wound tract. Thus, the guide may be made adjustable by turning a key to lock and / or unlock the adjustability of the guide. The key 412 may be located at the handle 406 of the probe such that the key is easily accessible by a user, even when the balloon and guide have been fully inserted into the wound.

[0060] Returning to Figures 2A to 2C, the balloon 304 may be attached to an end of the guide closest to the handle, and when the variable length guide is extended or shortened, the balloon attached to the end of the guide closest to the handle may move along with the guide, as shown in Figure 2B. Thus, the balloon can be fully inserted into the wound by unlocking and shortening the guide. In particular, there is then no part of the balloon that is not inside the wound. This is advantageous, because inflation of the balloon outside the wound can make the tamponade less effective in delivering pressure inside the wound. Figure 2C then shows the balloon 304’ being inflated, while the guide 302’ has been shortened from the guide’s fully extended position in which the balloon and guide have been inserted into a wound.

[0061] The balloon and the end of the guide closest to the handle may be further attached to the handle 306, and when the guide is shortened inside a wound, the handle may move along with the guide to contact an opening of the wound and seal the balloon 304’ and guide 302’ inside the wound. Advantageously, the handle can then be used to provide a place for the user to hold while pushing the unlocked guide and balloon into the wound. Additionally, the handle then provides a seal to keep both the guide and the balloon inside the wound. This ensures that no part of the balloon inflates outside the wound. Moreover, the handle may provide a hygienic seal to the wound, stopping dirt or debris from entering the wound.

[0062] Figures 4A to 4D show an embodiment of the expandable tamponade in which the guide may comprise a removable housing 514, and the balloon 504 may be provided within the guide. That is, instead of being placed inside the balloon 504, the guide may surround the balloon and provide some protection to the balloon when the balloon is being inserted into the wound. This can be advantageous, for example, when the wound was caused by shrapnel that remains inside the wound and could damage the balloon. This may also be advantageous, as the balloon is generally protected before and during insertion of the balloon and guide into the wound.

[0063] The housing 514 may be a tube, and the housing may be removable by sliding the tube along the balloon towards the handle, as shown in Figure 4C. That is, the balloon may be placed inside the tube that is open at one or both ends. The housing 514’ may then be removed by pulling the tube towards the handle and out of the wound. After the housing 514’ is removed, the balloon 504’ can be inflated, as shown in Figure 4D. Advantageously, removing the housing may remove the number of rigid parts inside a patient’s wound, which may be particularly desirable during transport of the patient.

[0064] The tamponade may further comprise a one-way clutch 516 for retaining the balloon inside the wound when the housing is removed. As shown in Figures 4C and 4D, the one way clutch may comprise teeth protruding from the handle towards the end of the balloon that is inserted first into the wound. The teeth may be biased towards the balloon, such that the teeth may catch the balloon when the housing is removed, thus preventing the balloon from being removed from the wound with the housing. Because the housing may be a smooth tube, the teeth only catch the balloon but not the housing. Alternatively, the housing may comprise one or more slits placed such that the housing does not contact the teeth. That is, the slits may enable the housing to slide past the teeth when the housing is removed. This means that the balloon is maintained inside the wound, even when there is friction between the housing and the balloon when the housing is removed after insertion of the housing and the balloon into the wound. The teeth may be made from a material that is rigid enough to catch the balloon when the housing is removed. Additionally, one of the slits in the housing may run along the length of the housing to enable the housing to be removed from the inserted tamponade completely. The slit running along the length of the housing may then be dimensioned such that a fluid supply tubing connected to the coupling means fits through the slit running along the length of the housing.

[0065] The guide may further comprise a support member (not shown in Figures 4A to 4D) located inside the housing, and at least one end of the balloon may be attached to the support member. The support member may be external to the balloon and the balloon may configured to expand at least partially around the support member. The support member may therefore, in addition to the one-way clutch, ensure that the balloon remains inside the wound tract when the guide is removed. Advantageously, by having the guide and support member external to the balloon, there is no need to insert a guide into the balloon which means that the balloon may be a standard balloon comprising a standard valve, and there is no need to account for the guide being placed inside the balloon.

[0066] The tamponade may further comprise a restraint for preventing a portion of the balloon outside the wound from inflating when the tamponade has been inserted into the wound. The restraint is shown in both Figures 1A to 1C (108) and in Figures 4A to 4D (508). As explained above, inflation of the balloon outside the wound may make the balloon less effective at delivering pressure to the wound to stem any bleeding. When it is not possible to insert the whole of the balloon into the wound, the restraint 108 / 508 may therefore be used to prevent inflation of the balloon outside the wound. The restraint may be slidably placed around the balloon to adjust a position of the restraint around the portion of the balloon outside the wound. That is, the restraint may be moved around the balloon during insertion of the balloon and guide into the wound to ensure that only the portion of the balloon inside the wound inflates. The restraint may be attached to the handle, and the restraint and handle may be slidably placed around the balloon to allow the handle to be positioned to contact an opening of the wound when the balloon has been inserted into the wound. For example, the balloon and guide may be inserted into the wound. When the balloon and guide have been inserted into the wound, the handle and restraint may then be moved towards the wound such that the handle contacts the wound opening. Advantageously, in this configuration it may be easier to move the restraint into a position suitable for preventing inflation of the balloon outside the wound. The handle may also seal the wound and protect the wound from any further dirt or debris. The restraint may be flexible or rigid. The restraint may be a tube or mesh or any other suitable material and shape. The restraint may have a tubular shape. For example, the restraint tube may have a diameter similar to the diameter of the uninflated balloon to effectively prevent inflation of the balloon outside the wound.

[0067] In the embodiment shown in Figures 1A to 1C, the restraint may preferably be rigid. This is because the restraint 108 may move along the balloon with the handle, and a rigid restraint may very effectively restrict the balloon from inflating outside the wound. Additionally, a rigid restraint may provide less friction between the balloon 104 and the restraint 108 when moving the restraint 108 along the balloon, as the balloon is unlikely to get caught on the rigid restraint. In the embodiment shown in Figures 4A to 4D, the restraint may preferably be flexible. For example, the restraint may be a mesh. This is because the housing 514 may further comprise a hold 518 to make it easier for the user to pull the housing from the wound when the balloon and guide have been inserted into the wound. When inserting the balloon and guide into the wound, the hold 518 may further help the user grip the housing better to push the housing and balloon into the wound. During this process, the restraint 508 may be compressed along the tamponade, and thus using a flexible material that enables compression along this axis, while effectively restraining the balloon along a perpendicular axis may be advantageous.

[0068] The tamponade may further comprise a rigid locator tip for guiding the balloon through the wound. The rigid locator tip may be the first part of the tamponade to be inserted into the wound, and thus may be shaped to ease the tamponade into the wound as well as through the wound. For example, the rigid locator tip can push through the tissue and musculature of / around the wound. The rigid locator tip may be attached to an exterior or interior portion of the balloon that first enters the wound. When the rigid locator tip is inside the balloon, the rigid locator tip may, for example, be attached to a tube carrying fluid into the balloon. In this case, the rigid locator tip may comprise a hole to allow fluid to enter the balloon from the fluid carrying tube. Alternatively, the rigid locator tip may be attached to the inside or the outside of the balloon itself. In a further embodiment, the rigid locator tip may be attached to an end of the support member first entering the wound. The locator tip may be made from a stiffer material than the balloon and may be shaped in various ways. For example, the locator tip may have a hemispherical shape or a rounded shape.

[0069] Alternatively, the rigid locator tip may be inside the balloon.

[0070] Figure 5 shows a fastening mechanism for fastening the tamponade to the patient, the fastening mechanism comprising a strap for strapping the tamponade in position on the patient. The tamponade may further comprise a fastening mechanism for fastening the tamponade to a patient. In some cases, the fastening may be coupled to the handle. For example, the handle may comprise a hilt or similar component which may be in close proximity or in contact with a wound opening, and the fastening may be coupled to the hilt. The fastening mechanism may be a Velcro (RTM) / hook and loop fastener strap 1102 for securing the tamponade to a patient. The strap may, for example, be wrapped around the patient and secured by pressing two ends of the strap 1102 together. In another example, the strap may be secured by threading through a loop and pulling the strap back on itself and then securing the strap using the Velcro (RTM) / hook and loop fastener. In another example, the strap may be used as a tourniquet and further comprise a windlass for tightening the tourniquet. Figure 6A shows a fastening mechanism for fastening the tamponade to the patient, the fastening mechanism comprising at least one hook for insertion into skin of the patient. In this embodiment, fastening of the tamponade is provided by at least one skin hook 1202. The at least one skin hook may be a barbed hook that digs into a patient’s skin. The at least one skin hook may be mounted on a hilt 1206 of the tamponade. That is, the tamponade may further comprise a hilt 1206 that may contact the patient’s skin when the tamponade is inserted into a wound tract. The at least one skin hook 1202 may be part of the hilt. For example, the hilt may further comprise a push-down mechanism 1204 for deploying the at least one skin hook. The skin hook may be attached to the push-down mechanism and may dig into the patient’s skin when the push-down mechanism is pushed down towards the patient’s skin.

[0071] Figure 6B shows the fastening mechanism of Figure 6A when the at least one skin hook is further attached to a strap. The at least one skin hook 1202’ may be connected to the tamponade via a strap 1206. The strap 1206 may be adjustable, such that the at least one skin hook 1202’ can hold the tamponade in place when the strap is pulled taut.

[0072] Figure 7A shows a fastening mechanism for fastening the tamponade to a patient, the fastening mechanism comprising an adhesive strip for adhering the tamponade to the skin of the patient. In this embodiment, fastening of the tamponade may be provided by at least one adhesive strip 602 or any other suitable adhesive. The adhesive may be covered by a peelable layer that may be peeled off the adhesive when the tamponade is inserted into a wound. There may be two adhesive strips 602, each on opposite sides of the tamponade when inserted into the wound. The at least one adhesive strip may be pressed onto a patient’s skin to attach the adhesive strip to the patient. The adhesive of the adhesive strip may be any suitable adhesive that ensures that the tamponade remains in place when inserted. The adhesive may also be skin-friendly. Additionally, the adhesive may be a type of adhesive that can easily be removed by applying a solvent solution to dissolve the adhesive. This is advantageous because the adhesive can then be easily removed before or during surgery, when the penetrating wound is treated further.

[0073] Figure 7B shows a fastening mechanism for fastening the tamponade to a patient, the fastening mechanism comprising an adhesive blister for adhering the tamponade to the skin of the patient. In this embodiment, fastening of the tamponade may be provided by an adhesive / glue that is applied to a hilt 612 of the tamponade and the user’s skin. The adhesive / glue 610 may be stored in a packet or blister 608 that is attached to the hilt. When the blister is broken by a user, glue may be released from the blister onto the patient’s skin and the hilt 612 of the tamponade such that the portion of the hilt contacting the patient’s skin is glued to the skin. The blister may be such that a breakable portion of the blister packet is on the side of the hilt facing the patient’s skin, and another portion of the blister packet is on the opposite side to the breakable portion. The other portion of the blister packet may then be pushed in to break the breakable portion of the blister packet and release the glue onto the patient’s skin and the part of the hilt contacting the patient’s skin. The glue may be cyanoacrylate glue. Alternatively, glue may be provided in a bottle or other container separate to the tamponade and applied to the patient’s skin and the tamponade hilt to attach the hilt to the patient’s skin. The user may hold the hilt still and press the hilt to the patient’s skin such that the glue may set and securely attach the hilt to the patient’s skin.

[0074] Figure 7C shows the fastening mechanism of Figure 7B when the adhesive 616 is further attached to a strap 614. That is, the strap may be glued to a patient’s skin. The strap 614 may be adjustable, such that the glue 616 can hold the tamponade in place when the strap is pulled taut.

[0075] Figure 8 shows a bristle internal retention mechanism. The balloon may comprise a retention mechanism on an external surface of the housing for retaining the tamponade within a wound tract. For example, bristles 702 may be attached to an exterior of the balloon. The bristles may be angled such that the tamponade is easy to insert but difficult to remove while inflated. This is because, when attempting to remove the tamponade, the bristles act as barbs that latch into a patient’s tissue in the wound tract. The bristles might be located on the whole of the housing. Alternatively, the bristles might be located at the tip of the housing only to anchor the tamponade to the patient’s wound. Additionally or alternatively, the retention mechanism may comprise similar components which grip and / or increase friction, thereby making it more difficult for the tamponade to slip out of the wound tract.

[0076] Figure 9 shows a Velcro (RTM) internal retention mechanism. A surface 802 of the housing contacting the wound tract may comprise Velcro (RTM) spots 804 to provide resistance to the tamponade exiting the wound tract. The hooks of the Velcro (RTM) spots may be angled such that the tamponade is easy to insert but difficult to remove. There may be one Velcro (RTM) spot only or there may be a plurality of Velcro (RTM) spots. The spots may have any suitable shape, such as, for example, a circular, rectangular, elliptical or any other suitable shape. There may be a higher density per surface area of spots at the tip of the tamponade to ensure that the tamponade is anchored to the wound tract when inserted. Each spot may have a size that is small compared to the size of the tamponade and / or the wound tract. Having a small size minimises the risk of one of the spots contacting an artery or other sensitive tissue inside the wound tract. However, if the spots do contact an artery inside the wound tract, the surrounding balloon of the tamponade should provide sufficient pressure to stem any bleeding from the artery. Additionally or alternatively, the retention mechanism may comprise similar components which grip and / or increase friction, thereby making it more difficult for the tamponade to slip out of the wound tract. Figure 10 shows a clip fastening mechanism. The clip 902 may clip onto a patient’s skin. The clip may be part of a hilt of the tamponade or may be attached to a strap which is in turn attached to the tamponade. The strap may be adjustable, such that the clip can hold the tamponade in place when the strap is pulled taut. The clip may comprise additional hooks 904 that may pierce the patient’s skin when the hook is applied and provide additional traction to keep the tamponade in place.

[0077] Figure 11 shows a treasury tag fastening mechanism. The tag 1000 may be attached to the tamponade via a strap or cord or other suitable attachment means. The tag may comprise a needle 1002 for threading the tag through a patient’s skin. The tag may further comprise a retaining portion 1004 connected to a cord 1006 for retaining the tag in place when the needle has been threaded through a user’s skin. The retaining portion 1004 may resist the tag moving by being attached to the cord 1006 (which is in turn attached to the tamponade), and by the retaining portion having a size larger than a hole created by the needle in at least one dimension. For example, the retaining portion may have a longitudinal shape. When threaded through the needle hole, the long side of the longitudinal portion may face the hole and thus prevent the cord moving back through the hole. The retaining portion 1004 may be housed inside the needle 1002 when the needle is being threaded through a patient’s skin. When the needle has been threaded through a patient’s skin, the retention means may be removed from the needle to keep the tag in place.

[0078] Figure 12 shows different types of fluid supply of a first responder kit for treating penetrating wounds. The kit comprises: the tamponade of the types described herein; and a fluid supply couplable to the coupling means, for expanding the balloon of the tamponade inside a wound tract. The fluid supply may expand the balloon of the tamponade inside the wound by supplying air or saline to expand the balloon. Advantageously, when the fluid is air, it may be easy to inflate the tamponade in the field, as no special equipment is needed to inflate the balloon.

[0079] The kit may further comprise: a mechanism for maintaining a pressure inside the balloon less than or equal to a predefined pressure value. When the fluid is air, the mechanism for maintaining a pressure inside the balloon may be an excess pressure valve for maintaining an air pressure inside the balloon below a predetermined pressure value. Thus, the expandable tamponade may comprise one or more pressure relief valves. The pressure relief valves may comprise valves that automatically vent gas from the balloon if the pressure within the balloon exceeds a predetermined threshold. The threshold value of the pressure may be dependent upon a number of factors. The threshold pressure could be above 220mm Hg or any other suitable value. There may further be audible or visual cues, such as a whistle or spinning wheel, when the fluid inside the balloon is venting via the pressure relief valve. To fill the balloon with air, a hand pump (sphygmomanometer) may be used.

[0080] When the fluid is saline, the mechanism for maintaining a pressure inside the balloon less than or equal to a predefined pressure value may be pneumatically maintaining the fluid pressure inside the balloon below a pre-determined fluid pressure value. There may further be audible or visual cues, such as a whistle or spinning wheel, when the pressure inside the balloon is too high. The mechanism may ensure that a pressure on the wound tissue provided by the balloon remains within safe limits while being effective at stemming any bleeding. The mechanism for pneumatically maintaining a fluid pressure may be an air filled syringe. Air is compressible and thus may allow for slight variations in the wound volume (e.g. patient moving) without a significant drop in applied pressure. Saline may be provided using an IV bag and the balloon may comprises connectors suitable for connecting to an IV bag for filling the balloon with saline.

[0081] The features described above with respect to the tamponade apply equally to the kit and therefore, for the sake of conciseness, are not repeated.

[0082] Those skilled in the art will appreciate that while the foregoing has described what is considered to be the best mode and where appropriate other modes of performing present techniques, the present techniques should not be limited to the specific configurations and methods disclosed in this description of the preferred embodiment. Those skilled in the art will recognise that present techniques have a broad range of applications, and that the embodiments may take a wide range of modifications without departing from any inventive concept as defined in the appended claims.

Claims

CLAIMS1. An expandable tamponade for treating penetrating wounds, comprising: a balloon; a guide for guiding the balloon into a wound tract; a handle connected to the guide, for inserting the balloon and guide into the wound tract; and a coupling means for coupling the balloon to a fluid supply to expand the balloon inside the wound tract.

2. The tamponade as claimed in claim 1 wherein the guide is provided within the balloon.

3. The tamponade as claimed in claim 2 wherein the guide is deformable.

4. The tamponade as claimed in claim 2 wherein the guide is a variable length guide.

5. The tamponade as claimed in claim 4, further comprising a telescopic extension mechanism having an external tube, and an internal portion provided by the variable length guide, the internal portion slidable within the external tube.

6. The tamponade as claimed in claim 5 wherein the handle comprises the external tube of the telescopic extension mechanism, and the external tube is inside the balloon.

7. The tamponade as claimed in claim 4, 5 or 6 wherein the variable length guide comprises a locking mechanism for locking the variable length guide in an unextended position or an extended position.

8. The tamponade as claimed in claim 7 wherein the locking mechanism is engaged by turning a key.

9. The tamponade as claimed in claim 5 wherein the handle comprises the external tube of the telescopic extension mechanism, and the external tube is slidable along a length of the balloon and variable length guide.

10. The tamponade as claimed in claim 1 wherein the guide comprises a removable housing, and the balloon is provided within the guide.

11. The tamponade as claimed in claim 10 wherein the removable housing is a tube.

12. The tamponade as claimed in claim 10 or 11 wherein the tamponade further comprises a one-way clutch for retaining the balloon inside the wound when the removable housing is removed.

13. The tamponade as claimed in any of claims 10 to 12 wherein the guide further comprises a support member located inside the housing, and at least one end of the balloon is attached to the support member.

14. The tamponade as claimed in claim 13 wherein the support member is external to the balloon and the balloon is configured to expand at least partially around the support member.

15. The tamponade as claimed in any preceding claim further comprising a rigid locator tip for guiding the balloon through the wound.

16. The tamponade as claimed in any preceding claim further comprising a fastening mechanism for fastening the tamponade to a patient.

17. The tamponade as claimed in claim 16 wherein the fastening is coupled to the handle.

18. The tamponade as claimed in claim 16 or 17 wherein the fastening mechanism comprises a strap for strapping the tamponade in position on the patient.

19. The tamponade as claimed in claim 16 or 17 wherein the fastening mechanism comprises at least one hook for insertion into skin of the patient.

20. The tamponade as claimed in claim 16 or 17 wherein the fastening mechanism comprises a strap and a hook for insertion into skin of the patient.

21. The tamponade as claimed in claim 16 or 17 wherein the fastening mechanism comprises adhesive for adhering the tamponade to skin of the patient.

22. The tamponade as claimed in any preceding claim wherein the balloon comprises a retention mechanism on an external surface of the balloon for retaining the tamponade within the wound tract.

23. A first responder kit for treating penetrating wounds, the kit comprising: the tamponade as claimed in any of claims 1 to 22; and a fluid supply couplable to the coupling means, for expanding the balloon of the tamponade inside a wound tract.

24. The kit as claimed in claim 23 further comprising: a mechanism for maintaining a pressure inside the balloon less than or equal to a predefined pressure value.