Adjustable internal tourniquet

Abstract

Provided herein are adjustable internal tourniquet device and system having an inflatable segmented balloon configured to exert pressure on a site of injury. Further provided are methods of using the same for controlling traumatic hemorrhage wounds.

Description

[0001] ADJUSTABLE INTERNAL TOURNIQUET

[0002] TECHNICAL FIELD

[0003] The present disclosure relates generally to adjustable internal tourniquet device, system and method of using the same for controlling traumatic hemorrhage wounds.

[0004] BACKGROUND

[0005] Tourniquets have been a critical component in medical practice, primarily used to control bleeding by temporarily constricting blood flow in a limb. Traditional tourniquets, which include a strap or band tightened around a limb, are widely used in both emergency and surgical settings. Despite their effectiveness, conventional external tourniquets present several challenges and limitations that can impact their overall utility and safety.

[0006] One major limitation of external tourniquets is the potential for incomplete occlusion of blood flow, particularly in larger limbs, or other inaccessible tissues. This can lead to inadequate control of hemorrhage, posing a serious risk to the patient. Additionally, external tourniquets can cause significant pain and discomfort due to the pressure applied on the skin and underlying tissues. Prolonged use of external tourniquets can result in nerve damage, skin injuries, and other complications.

[0007] Various other tourniquet designs, including pneumatic tourniquets and internal tourniquets exist. However, such systems often require bulky equipment and can be cumbersome to operate, limiting their applicability in emergency situations where speed and simplicity are crucial.

[0008] Accordingly, there is a need in the art for enhanced internal tourniquets devices and systems that allow the application of adjustable, localized pressure on the site of injury, which are cost effective, safe, efficient and easy for use.

[0009] SUMMARY

[0010] Aspects of the disclosure, according to some embodiments, relate generally to an adjustable internal tourniquet device, system and methods of use thereof, for controlling traumatic hemorrhage wounds, including deep narrow tract wounds, such as junctional gunshot wounds or stabbing wounds, in a safe, effective and efficient manner. According to some embodiments, there is provided herein an internal adjustable tourniquet device, used for restricting or halting blood flow in injured body parts, during medical emergencies, in particular, for penetrating injuries caused by, for example, gunshots or stub wound. Advantageously, the internal tourniquet device disclosed herein improves efficiency, effectiveness, and ease of application in various medical scenarios (e.g., battlefield or emergency field conditions), due to its ability to adjust to the size and / or shape of the wound tract, and to apply an adjusted amount of pressure to the site of injury.

[0011] According to some embodiments, the disclosed internal adjustable tourniquet device and system can advantageously be used in various types of penetrating injuries, at different body parts, such as, limbs, groin, neck, shoulder, pelvic, armpit, and the like.

[0012] According to some embodiments, the internal adjustable tourniquet device disclosed herein includes an advantageous inflatable, segmented balloon. The balloon is configured to be initially inserted in a deflated state along the wound tract and upon inflation, the segmented balloon is configured to expand initially only at its innermost, distal segment, effectively tamponing the surrounding tissue in that area, and when reaching a designated pressure in that segment, further inflation of a sequential segment is facilitated. Such sequential inflation ensures that the expansion of the more proximal segment does not occur at the expense of the immediately adjacent distal segment. Accordingly, segment after segment, the balloon can undergo sequential inflation (in a distal to proximal direction), while providing pressure along the wound tract.

[0013] According to some embodiments, the segmented inflation mechanism can further enable regulating or controlling the release of medical substances, such as, clotting substances from the device.

[0014] According to some embodiments, advantageously, the adjustable internal tourniquet device can thus serve as a crucial tool for managing traumatic hemorrhage, while providing a customized / tailored approach to diverse wound scenarios, both in terms of size and depth of wound, relative to the specific anatomical location.

[0015] According to some embodiments, the device and system disclosed herein can advantageously replace standard, non-invasive tourniquets, which can only be used on certain body parts (such as limbs) and are not designed to apply precise, localized pressure at the internal site of bleeding. According to some embodiments, there is provided herein as internal adjustable tourniquet device for controlling traumatic hemorrhage from a penetrating wound, the device includes: a flexible elongated body having a distal end configured for insertion into the wound; and an inflatable segmented balloon disposed along the length of the distal portion of the elongated body, wherein the inflatable segmented balloon includes a plurality of sequential bladders, each of the bladders is in fluid communication with the elongated body; wherein the bladders are configured to inflate sequentially, in a distal to proximal direction, such that, only when a distal bladder is inflated to an internal threshold pressure, a sequential proximal bladder is capable of being inflated, thereby allowing maintaining sufficient pressure on or along the wound and at least partially reducing or halting hemorrhage from the wound.

[0016] According to some embodiments, the threshold pressure may be predetermined. In some embodiments, the threshold pressure may be essentially similar between two or more, or between each of the bladders.

[0017] According to some embodiments, each two sequential bladders may be similar, identical or different with respect of size and / or shape. Each possibility is a separate embodiment.

[0018] According to some embodiments, the walls of the balloon may be made of polyethylene (PE), ethylene-vinyl acetate (EVA), polyvinyl chloride (PVC), thermoplastic polyurethane (TPU), latex, biocompatible rubber, Polyetheretherketone (PEEK), Polyamide (PA), Teflon (PTFE), Polypropylene (PP), Polyethylene terephthalate (PET), Silicone, Polyurethane (PU), Thermoplastic elastomers (TPE), or any combinations thereof. Each possibility is a separate embodiment.

[0019] According to some embodiments, each bladder includes an inlet, allowing fluid to be inserted thereto, and an outlet configured to allow releasing of fluid from the bladder.

[0020] According to some embodiments, the device may include, at a proximal end thereof one or more fluid inlets.

[0021] According to some embodiments, the device may include, at a proximal region thereof, an inflating mechanism having one or more valves, configured to control fluid flow to a respective bladder. According to some embodiments, the device may include, at a proximal region thereof, an inflating mechanism having a plurality of control valves, each valve is configured to control fluid flow to a respective bladder.

[0022] According to some embodiments, the control valves may be arranged linearly, thereby enabling sequential inflation of the segmented bladders, according to a predetermined distal to proximal order.

[0023] According to some embodiments, the control valves may include parallelly arranged check-valves having varying pressure thresholds, enabling the sequential inflation of the segmented bladders.

[0024] According to some embodiments, each control valve is fluidly connected to a respective bladder, via a respective fluid conduit.

[0025] According to some embodiments, the inflation mechanism further includes a selector. In some embodiments, the inflation mechanism may further include an inlet fluid connector.

[0026] According to some embodiments, the device may further include a blood drainage lumen.

[0027] According to some embodiments, the blood drainage lumen is configured to drain blood from the hemorrhage region to a proximal region of the device, thereby enabling visualization of blood flow at the proximal region of the device.

[0028] According to some embodiments, the device may further include one or more pressure release valves, configured to release pressure in the bladder.

[0029] According to some embodiments, the device may further include an anchoring member, configured to anchor the device, after being positioned in the wound.

[0030] According to some embodiments, the balloon may include or is coated with one or more medical substances.

[0031] According to some embodiments, the medical substances may include procoagulation substances, antiseptic substances, antibiotics, analgesic substances, biological glue, or any combination thereof. Each possibility is a separate embodiment,

[0032] According to some embodiments, the device may further include a guidewire, configured to aid in inserting / aiming the device into the tract wound. In some embodiments, the device may include a guidewire lumen for over-the-wire delivery of the device.

[0033] According to some embodiments, the device may include an atraumatic distal tip.

[0034] According to some embodiments, the wound may be a tract wound and the device may at least partially be inserted along the wound tract.

[0035] According to some embodiments, the blood vessel may be located in a limb, shoulder, neck, abdomen, pelvic, armpit, or any combinations thereof. Each possibility is a separate embodiment.

[0036] According to some embodiments, there is provided a system for controlling traumatic hemorrhage from a penetrating wound, the system includes the device disclosed herein and an inflation unit configured to connect to the proximal end of the device and provide fluid to an inflation mechanism associated with the device.

[0037] In some embodiments, the inflation unit is configured to connect to the inflation mechanism of the device. In some embodiments, the connection may be facilitated via corresponding connectors (e.g., a male and female Luer connectors, positioned, for example, on the inflation mechanism and the inflation unit, respectively ).

[0038] According to some embodiments, the inflation unit may include a pump, a bag, a syringe, an actuator, or any combinations thereof. Each possibility is a separate embodiment.

[0039] According to some embodiments, the fluid may include air, gas and / or liquid.

[0040] According to some embodiments, the fluid provided by the inflation unit is a pressurized fluid.

[0041] According to some embodiments, the inflation unit may be configured to deliver a designated volume of fluid, for every cycle of operation thereof.

[0042] According to some embodiments, the inflation unit may be reversibly associated with the device.

[0043] According to some embodiments, the inflation unit may be permanently associated or integrally formed with the device.

[0044] According to some embodiments, the inflation unit may be operated manually. According to some embodiments, the inflation unit may be operated semi- automatically or automatically.

[0045] According to some embodiments, the inflation unit may be disposable.

[0046] According to some embodiments, the inflation unit is re-usable.

[0047] According to some embodiments, there is provided a method for controlling traumatic hemorrhage from a penetrating wound, the method includes one or more of the steps of: inserting the device or the system as disclosed herein to the wound site; providing fluid to the segmented balloon, to facilitate sequential inflation of the bladders, until sufficient pressure is achieved; and monitoring blood drainage from the wound.

[0048] According to some embodiments, the method may further include anchoring the device once inserted into the wound site.

[0049] According to some embodiments, the method may further include allowing application of medical substances to or in close proximity to the wound site.

[0050] According to some embodiments, the method may further include removing fluid from inflated bladder(s), thereby deflating the bladders and allowing removal of the device from the wound site and / or body part.

[0051] According to some embodiments, the method may further include connecting an inflation mechanism and / or an inflation unit to the proximal end of the device, prior to, during or after inserting the device to the wound site.

[0052] Certain embodiments of the present disclosure may include some, all, or none of the above advantages. One or more other technical advantages may be readily apparent to those skilled in the art from the figures, descriptions, and claims included herein. Moreover, while specific advantages have been enumerated above, various embodiments may include all, some, or none of the enumerated advantages.

[0053] BRIEF DESCRIPTION OF THE FIGURES

[0054] Some embodiments of the disclosure are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some embodiments may be practiced. The figures are for the purpose of illustrative description and no attempt is made to show structural details of an embodiment in more detail than is necessary for a fundamental understanding of the disclosure. For the sake of clarity, some objects depicted in the figures are not to scale.

[0055] In the figures:

[0056] Figure 1A shows a schematic perspective view of an adjustable tourniquet device having a segmented balloon, in a non-inflated (“closed”) state, according to some embodiments;

[0057] Figure IB shows a schematic perspective view of an adjustable tourniquet device having a segmented balloon, in fully inflated state, according to some embodiments;

[0058] Figure 1C shows a schematic perspective view of an adjustable tourniquet device having a segmented balloon, in fully inflated state, according to some embodiments;

[0059] Figure 2 shows a schematic front view cross section of an adjustable tourniquet device, according to some embodiments;

[0060] Figure 3A shows a schematic front view of a cross section of a proximal region of an adjustable tourniquet device, according to some embodiments;

[0061] Figure 3B shows a schematic front view of a cross section of a proximal region of an adjustable tourniquet device, according to some embodiments;

[0062] Figure 3C shows a schematic view of inflation mechanism of an adjustable tourniquet device, according to some embodiments;

[0063] Figure 3D shows a schematic view of inflation mechanism of an adjustable tourniquet device, according to some embodiments;

[0064] Figure 3E shows a schematic view of inflation mechanism of an adjustable tourniquet device, according to some embodiments;

[0065] Figure 4A shows a schematic side view of a cross section of a segmented, fully inflated balloon, at the distal region of an adjustable tourniquet device, according to some embodiments;

[0066] Figure 4B shows a schematic cross section side view of a segmented, deflated balloon, at the distal region of an adjustable tourniquet device, according to some embodiments.

[0067] Figure 5 shows schematic views of an adjustable tourniquet device, at various states of inflation, starting at a deflated state, according to some embodiments; Figure 6A shows a schematic view of an adjustable tourniquet system including an adjustable tourniquet device and an inflation unit, according to some embodiments;

[0068] Figure 6B shows a schematic view of an adjustable tourniquet system including an adjustable tourniquet device and an inflation unit, according to some embodiments;

[0069] Figure 7 shows a schematic view of an adjustable tourniquet system positioned at a site of internal injury, according to some embodiments; and

[0070] Figure 8 shows a block diagram of steps in a method for using an internal tourniquet system, according to some embodiments.

[0071] DETAILED DESCRIPTION

[0072] The principles, uses, and implementations of the teachings herein may be better understood with reference to the accompanying description and figures. Upon perusal of the description and figures present herein, one skilled in the art will be able to implement the teachings herein without undue effort or experimentation. In the figures, same reference numerals refer to same parts throughout.

[0073] According to some embodiments, there are provided herein advantageous devices and systems for controlling traumatic hemorrhage from wounds. In particular, provided herein are adjustable internal tourniquet device and system, for controlling blood flow from deep narrow tract wounds, such as junctional gunshot or stabbing wounds, afflicted at a verity of body parts.

[0074] According to some embodiments, the internal adjustable tourniquet device disclosed herein includes an advantageous inflatable, single yet segmented biocompatible and puncture resistant balloon. The balloon is configured to be initially inserted in a deflated state along the wound tract. Upon inflation of the balloon using suitable fluid (provided from a proximal region of the device), the segmented balloon is configured to expand initially only at its innermost, distal segment (also referred to as bladder, chamber or pocket), effectively tamponing the surrounding tissue in that area. When reaching a designated (for example, a predetermined) pressure in the innermost first segment, further inflation (i.e., introduction of fluid), activates the inflation of the next (sequential) segment. Such sequential inflation ensures that the expansion of the more proximal segment does not occur at the expense of the previous one. Accordingly, segment after segment, the balloon can undergo sequential inflation in an in-out direction (i.e., in a distal to proximal direction), while maintaining / providing pressure along the wound tract. The inflation may proceed until hemorrhage is at least partially halted.

[0075] According to some embodiments, advantageously, according to the wound characteristics (for example, depth, width, type of injury, injured body part, etc.), and clinical characteristics, the device and system disclosed herein allow versatility of use for different clinical scenarios, using a controllable sequential inflation which is determined according to the inflation action (i.e., fluid introduction), without any other adjustments needed. Advantageously, this results in a device and system which are cost effective, easy to operate and maneuver, safe and highly effective for use on various types, sizes and / or locations of wounds.

[0076] According to some embodiments, the user’s (operator, such as a health care provider, physician, medic, paramedical stuff, etc.) control over the balloon's length and size enables versatile application of the device in various anatomical locations, allowing deeper or smaller compression in some body areas and more superficial or larger compression in others. The length of the balloon can be adjusted by controlling fluid flow (and corresponding pressure) by the user, whereby only one segment, some of the segments or all segments of the balloon may be inflated. Moreover, in case of accidental balloon rapturing, the segmented mechanism can facilitate reduction of fluid leakage, while the other inflated segments can compensate for the loss of pressure on the wound.

[0077] According to some embodiments, the disclosed pneumatic internal tourniquet may be used for temporary hemorrhage control at junctional anatomical sites, such as the axillary and inguinal regions, and / or for achieving hemostasis in extremity hemorrhage.

[0078] As used herein, the term “balloon” relates to a cell capable of being inflated, deflated, or maintaining fluid therein. The cell includes more than one internal inflatable spaces (also referred to as “pocket”, “bladder”, “chamber” or “segment”), which are sequentially arranges, and each functions as a separate cell capable of being inflated, deflated, or maintain fluid therein. In some embodiments, the pockets are linearly (horizontally or vertically) arranged in the balloon. In some embodiments, the bladders may be separated from one another or may have some overlap therebetween. In some embodiments, the balloon may include at least two, at least three, at least four, at least 5 bladders. In some exemplary embodiments, the balloon may include three bladders. In some embodiments, the bladders may be similar of different with respect of size, shape, volume, diameter, width, and the like.

[0079] As referred to herein, the term “fluid” is directed to include gas or liquid. In some embodiments, the gas may include, for example, but not limited to: air, oxygen, nitrogen, and the like or any combinations thereof. In some embodiments, the liquid may be, for example, not limited to: water, saline, aqueous solution, and the like, or any combinations thereof.

[0080] In the context of the present disclosure, the terms “distal” and “proximal” are used with reference to the orientation of the tourniquet device during intended use. The proximal end is the end that remains outside or near the entry point of the patient’s body and is typically closer to the user (operator), while the distal end is the end that is advanced into the patient (i.e., into the wound).

[0081] Reference is now made to Fig. 1A, which shows a schematic perspective view of an adjustable tourniquet device having a segmented balloon, in a non-inflated (“closed”) state, according to some embodiments. As shown in Fig. 1 A, adjustable tourniquet device 100, includes an elongated body 102, having a proximal region 104 and a distal region 106. The distal region is configured to be inserted into a body target region, in particular, to a wound site. Device 100 further includes, at a distal region thereof, an inflatable, segmented balloon 102. Segmented balloon 102 includes a plurality of segments / bladders / pockets, which are configured to inflate sequentially, in a distal to a proximal direction, such that only when a first (most distal) bladder is inflated to an internal threshold pressure, a consequent (more proximal) bladder is allowed to inflate. In the example shown in Fig. 1A, balloon 102 includes three consecutive segments, shown as deflated bladder 110A (most distal), HOB and HOC (most proximal). As detailed herein, the balloon may be made of any suitable compressible / inflatable biocompatible material. The elongated body of the device may be rigid, semi rigid, partially flexible, and further includes one or more internal lumens / channels / conduits, configured to deliver / pass fluid from the proximal region of the device (in particular via the inflation mechanism) towards the distal region thereof, and in particular, to the segmented balloon, to allow sequential inflation thereof. At the proximal region of device 100, inflation mechanism (also referred to as “inflation assembly”) 112 is positioned. As detailed herein, such inflation mechanism includes one or more valves, configured to allow sequential control over the inflation of the distal segmented balloon. Inflation mechanism 112 may be an integral part of the device, permanently connected thereto, or may be reversibly associated therewith. As detailed herein, one or more internal adapters may be used to fluidly connect the inflation mechanism and the internal fluid conduits connected to the bladders of the balloon. The distal end 114 of device 100 may include one or more openings, allowing for blood drainage, which may be conveyed, via corresponding conduits, towards a more proximal region of the device, thereby enabling a user to visually or otherwise identify blood flow from the wound site. Additionally, as shown in Fig. 1 A, the device may further include connectors / adapters / release valves 108, which may be used to drain fluids from the device, and in particular, to allow deflation of the balloon, from an inflated state to a deflated state, by removing fluid therefrom. In some embodiments, additionally or alternatively, connectors 108 may be used to provide fluids to a distal region of the device, such fluids may include, for example, saline, medical substances, and the like. As detailed below herein, to a proximal end 116 of device 100, an inflation unit may be connected, wherein the inflation unit is configured to provide pressurized fluid (for example, at a designated amount) to the inflation mechanism, and hence to the inflatable balloon.

[0082] Reference is now made to Fig. IB which shows a schematic perspective view of an adjustable tourniquet device having a segmented balloon, in fully inflated state, according to some embodiments. As shown in Fig. IB, adjustable tourniquets device 150 (which may be the same device as in Fig. 1 A, or a similar device), includes an elongated body 152, having a proximal region 154 and a distal region 156. The distal region is configured to be inserted into a body target region, in particular, to a wound site, whereby distal tip 162 of device 150 is configured to be in close proximity, at / in the wound site. Device 150 includes, at a distal region thereof, an inflatable, segmented balloon 152, shown in a fully inflated state. Segmented balloon 152 includes a plurality of segments / bladders / pockets, which are configured to inflate sequentially, in a distal to a proximal direction, such that only when a first (most distal) bladder is inflated to an internal threshold pressure, a consequent (more proximal) bladder is allowed to inflate. In the example shown in Fig. IB, balloon 152 includes three consecutive segments, shown as fully inflated bladder 160A (most distal), fully inflated bladder 160B and fully inflated bladder 160C (most proximal). Further shown are connectors / adaptors 158, which are configured to enable removing fluids from one or more bladders and / or allowing inserting fluids to a distal region of the device. Thus, when fully inflated, the tourniquet can exert pressure on a large wound area, along the wound tract, wherein the length of the inflated balloon can be determined by the number of inflated bladders.

[0083] Reference is now made to Fig. 1C which shows a schematic perspective view of an adjustable tourniquet device having a segmented balloon, in fully inflated state, according to some embodiments. As shown in Fig. 1C, adjustable tourniquet device 170, includes an elongated body 172, having a proximal region and a distal region 176. The distal region is configured to be inserted into a body target region, in particular, to a wound site, whereby distal tip 178 of device 170 is configured to be in close proximity, at / in the wound site. Device 170 includes, at a distal region thereof, an inflatable, segmented balloon 182, shown in a fully inflated state. Segmented balloon 182 includes a plurality of segments / bladders / pockets, which are configured to inflate sequentially, in a distal to a proximal direction, such that only when a first (most distal) bladder is inflated to an internal threshold pressure, a consequent (more proximal) bladder is allowed to inflate. In the example shown in Fig. 1C, balloon 182 includes three consecutive segments, shown as fully inflated bladder 184A (most distal), fully inflated bladder 184B and fully inflated bladder 184C (most proximal). Further shown is the proximal end of stylet / guidewire 186, that is utilized to facilitate the insertion of the tourniquet device into the target region (e.g., the wound site, along the wound tract). Further shown is inflation mechanism 190, which is configured to facilitate the sequential transfer of fluid to the bladders, from a fluid source / unit. Inflation mechanism 190, located at the proximal region of the elongated body, includes selector 192, enabling the sequential fluid connection to the bladers, as further detailed herein below. Inflation mechanism 190 further includes a connector 194 (such as a Luer connector), enabling connecting and establishing fluid connection with an inflation unit (e.g., a pump).

[0084] Reference is now made to Fig. 2, which shows a schematic cross section front view of an adjustable tourniquet device, according to some embodiments. As shown in Fig. 2, adjustable tourniquet device 200, includes an elongated body 202, having a proximal region 204 and a distal region 206. The distal region is configured to be inserted into a body target region, in particular, to a wound site. Device 200 further includes, at a distal region thereof, an inflatable, segmented balloon 202. Segmented balloon 202 includes a plurality of segments / bladders / pockets, which are configured to inflate sequentially, in a distal to a proximal direction, as detailed herein. In the example shown in Fig. 2, balloon 202 includes three consecutive segments, shown as deflated bladder 210A (most distal), 210B and 210C (most proximal). As shown in Fig. 2, the elongated body of the device include internal lum ens / channel s / conduits (shown as exemplary lumens 216A-B) configured to deliver / pass fluid from the proximal region of the device (in particular from inflation mechanism 220) towards the distal region thereof, and in particular, to bladders of balloon 202, to allow sequential inflation thereof. As detailed herein, inflation mechanism 220 includes one or more valves, configured to allow sequential control over the inflation of the distal segmented balloon. Inflation mechanism 212 may be an integral part of the device, permanently connected thereto, or may be reversibly associated therewith. In the example shown in Fig. 2, internal adapters 218A- B, are used to fluidly connect inflation mechanism 220 to the internal fluid conduits (such as conduits 216A-B), and to respective bladders 210A-B of balloon 202. As shown in Fig. 2, conduit 216A is fluidly connected to bladder 210A, whereby opening 214A is configured to allow fluid passage from conduit 216A to balloon 210A. Likewise, conduit 216B is fluidly connected to bladder 210B, whereby opening 214B is configured to allow fluid passage from conduit 216B to balloon 210B. Not shown in the presented section are corresponding conduit and opening allowing fluid passage to bladder 214C. As further shown in Fig. 2, in proximity to distal tip 212, device 200 includes one or more openings (opening 212 is shown), allowing for blood drainage. Blood from the wound site may enter the blood drainage opening 212 and may be conveyed, via corresponding conduits (not shown in the cross section presented in Fig. 2), towards a proximal region, enabling a user to visually or otherwise identify blood flow from the wound site. Such tracking of blood flow can assist the user in operating the device, for example, to determine, if the bleeding is reduced or halted, meaning that the amount of pressure exerted is sufficient, and there is no need to further inflate the balloon.

[0085] According to some embodiments, the elongated body of the device may include a plurality of internal lumens, each may extend along at least part of a length thereof. In some embodiments, the lumens may include, for example, but not limited to: a lumen for blood drainage, providing clinical insights to the operator, with the option for blockage; dedicated lumens directing fluid from the inflation mechanism to the segmented balloon (for example, from respective valve chambers to respective balloon segment); collecting tube lumen for pressure release, and the like. In some embodiments, the distal tip of the device is atraumatic. In some embodiments, the tip may be flexible.

[0086] In some embodiments, the length of the shaft body may be in the range of about 200-600mm, for example, 300-500mm, for example, 400-485mm. In some embodiments, the length of the device (including an inflation mechanism) may be in the range of about 250-700mm, for example, about 550mm. In some embodiments, the diameter of the elongated shaft may be in the range of about 2-8mm, for example, about 3-6mm, about 4-5mm, about 4.6mm. In some embodiments, the shaft may have a shore value in the range of about 20-120Shore, for example, 30-100shore, 40-80 shore, about 70 shore.

[0087] In some embodiments, pressure release from the balloon may be regulated by a valve (such as valve s / connectors 108 shown in Fig. 1A), to prevent overinflation and potential rupture. In some embodiments, such valve(s) can allow regulating the threshold pressure at which pressure release is initiated. According to some embodiments, such pressure release functionality may be particularly crucial in clinical situations necessitating a smaller maximal balloon size or where excessive inflation volume may pose clinical complications. Such considerations are especially pertinent in cases of neck injuries, where overinflation risks compromising airway integrity through compression. In some embodiments, the pressure release valve enables complete pressure release during removal of the device from the wound.

[0088] According to some embodiments, the device may further include a guidewire for facilitating insertion or placement of the device. In some embodiments, the guidewire (such as a Nitinol guidewire, silicone guidewire, stylet, and the like) may be removable or integral part of the device. In some embodiments, the guidewire is passed through an internal lumen of the device. In some embodiments, the guidewire is a stylet. In some embodiments, the guidewire may have a diameter in the range of about 0.2-1.5mm. In some embodiments, the guidewire may be a flexible, semi-rigid or rigid wire or rod. Each possibility is a separate embodiment.

[0089] According to some embodiments, additionally or alternatively, the device may be associated with an insertion tube facilitating insertion of the device through the tissue. In some embodiments, the elongated body of the device may be made of various biocompatible materials and may assume various shapes and sizes to accommodate different clinical needs.

[0090] Reference is now made to Fig. 3A, which shows a schematic front view of a cross section of a proximal region of an adjustable tourniquet device, according to some embodiments. As shown in Fig. 3A, inflating mechanism 320 includes a plurality of valves, such as, valves 332A-C. The valves can be arranged linearly, as shown in Fig. 3 A, however, any other configuration of valves (such as, parallel configuration) may be used, as long as sequential inflation of corresponding bladders is facilitated. In the arrangement shown in Fig. 3 A, sequential inflation is facilitated by the linear arrangement of valves 332A-C, whereby, precise / accurate / requested inflation of different balloon segments in a predetermined sequence is automatically or semi automatically facilitated. For example, in the configuration presented in Fig. 3 A, once an amount of fluid is inserted into the body of inflating mechanism 320, for example, via inlet 330, said fluid is conveyed, by the action of valve 332A towards opening 334 and conduit 316A, which is fluidly connected to corresponding (most distal) bladder. Once the corresponding bladder has been inflated to a threshold pressure value, valve 332B may open and allow fluid passage to the sequential bladder (via corresponding conduits, such as, conduit 316B). Likewise, when the corresponding bladder has been inflated to a threshold pressure value, valve 332C may open and allow fluid passage to the sequential (more proximal) bladder via a corresponding conduit, etc. Thus, by providing / inserting pressurized fluid to the inflation mechanism, at each cycle of insertion, an amount of fluid is conveyed to a corresponding bladder, and once said bladder is inflated to a threshold pressure (which may be predetermined or adjusted during use), the consequent bladder is allowed to received fluid and inflate. In some embodiments, at each cycle of inserting fluid to the inflation mechanism, similar or equal amount of fluid is inserted. In some embodiments, the inflation mechanism may be an integral part of the device. In some embodiments, the inflation mechanism may be separable from the elongated body of the device, and may be reversibly connected thereto / associated therewith. In some embodiments, the inflation mechanism is a reusable. In some embodiments, the inflation mechanism may be physically and / or fluidly connected to the conduits of the device via corresponding internal adaptors, which ensure a precise, un-interrupted, secured and continuous fluid connection. In the example shown in Fig. 3A, internal adaptors 318A-B are presented, which allow smooth and directional connection of the inflation mechanism to the corresponding internal conduits of the device. The adapters may include any type of suitable adapters, such as, click adaptors, hinges, screwing means, and the like, or any combinations thereof.

[0091] Reference is now made to Fig- 3B, which shows a schematic front view of a cross section of a proximal region of an adjustable tourniquet device, according to some embodiments. As shown in Fig. 3B, inflating mechanism 300 includes one or more pressure release valves, such as valve 306, an inlet connector 302 (for example, in the form of a Luer connector, enabling connecting to an inflation unit), and selector 304. In some embodiments, the selector may be in the form of a switch, a button, a spring, and the like. Further shown in Fig. 3B is device body 310 and guidewire (stylet) 312, positioned within the elongated body of the device. In the arrangement shown in Fig. 3B, sequential inflation is facilitated by action of pressure release valve 306 and selector 304, whereby, wherein precise / accurate / requested inflation of different balloon segments in a predetermined sequence is automatically or semi automatically facilitated, by diverting fluid to the corresponding bladder, according to a sequential order. For example, in the configuration presented in Fig. 3B, once an amount of fluid is inserted into the body of inflating mechanism 300, for example, via inlet 302, said fluid is conveyed, towards opening 314A, which is fluidly connected (via, for example, a conduit in body 310 of the device), to the corresponding (most distal) bladder. Once the corresponding bladder has been inflated to a threshold pressure value, selector 304 may change position (manually, semi-automatically or automatically), to directly or indirectly allow fluid passage to the sequential bladder, via opening 314B and a corresponding conduit. Likewise, when the corresponding bladder has been inflated to a threshold pressure value, selector 304 may change position, to directly or indirectly allow fluid passage to the sequential (more proximal) bladder, via opening 314C and a corresponding conduit. Thus, by providing / inserting pressurized fluid to the inflation mechanism, at each cycle of insertion, an amount of fluid is conveyed to a corresponding bladder, and once said bladder is inflated to a threshold pressure (which may be predetermined or adjusted during use), the consequent bladder is allowed to received fluid and inflate. In some embodiments, at each cycle of inserting fluid to the inflation mechanism, similar or equal amount of fluid is inserted. In some embodiments, the inflation mechanism may be an integral part of the device. In some embodiments, the inflation mechanism may be separable from the elongated body of the device, and may be reversibly connected thereto / associated therewith. In some embodiments, the inflation mechanism is a reusable. In some embodiments, the inflation mechanism may be physically and / or fluidly connected to the conduits of the device via corresponding internal adaptors, which ensure a precise, un-interrupted, secured and continuous fluid connection. In some embodiments, the inflation mechanism is integrally formed with the device body. In some embodiments, the inflation mechanism is permanently associated with the device body. In some embodiments, the inflation mechanism is permanently attached to the device body. In some embodiments, the inflation mechanism is reversibly associated with the device body.

[0092] Reference is now made to Figs. 3C-3E, showing schematic views of inflation mechanisms of an adjustable tourniquet device, according to some embodiments. Fig. 3C shows inflation mechanism 340, having ports (342A-C), each configured to sequentially connect to a fluid supplying device (e.g., a hand pump), to provide fluid to a respective chamber to facilitate inflation thereof in sequential manner, the inflation mechanism may be fluidly and / or physically connected to the tourniquet device body, via connector 346. Fig. 3D shows inflation mechanism 350, in the form of cylindrical selector. Inflation mechanism 350 is fluidly connected to each of the chambers via conduits 352A-C on the one hand, and connected to a fluid supply (e.g., a hand pump) via inlet 356. Manual or automatic switch between positions of the selector, when predetermined pressure in a chambers is reached facilitate the sequential inflation of the bladders. Fig. 3E shows inflation mechanism 360, in the form of a linear selector. Inflation mechanism 360 is fluidly connected to each of the chambers via conduits 362A- C on the one hand, and connected to a fluid supply (e.g., a hand pump) via inlet 366. The inflation mechanism further includes a pressure release valve, 364, facilitating the sequential inflation. Manual or automatic switch between positions of the selector, when pre-determined pressure in a chamber is reached, facilitate the sequential inflation of the bladders.

[0093] According to some embodiments, the sequential inflation of the balloon, using the inflation mechanism may be facilitated by utilizing non-sequential valves (such as, check valves) having varying pressure thresholds, arranged in parallel. Such valves can open systematically based on pressure differentials, adjusted / customized to the characteristics of each balloon segment and surrounding tissue. In some embodiments, the valves may include aby type of suitable valves, such as, unidirectional valves, pressure valves, check vales, ball valve, butterfly valve, gate valve, needle valve, and the like, or any combinations thereof.

[0094] Reference is now made to Fig. 4A, which shows a cross section side view of a segmented, fully inflated balloon, at the distal region of an adjustable tourniquet device, according to some embodiments. Shown in Fig. 4A is segmented balloon 402 having three segmented bladders, 410A-C, which are shown in full inflated state. The bladers have been inflated sequentially, starting at the distal bladder 410A. Once the bladder is inflated to a threshold pressure, consequent bladder 410B is allowed to receive fluid and inflate. Likewise, when bladder 410B is inflated to a threshold pressure, consequent bladder 410C is allowed to receive fluid and inflate. As detailed above, each of the bladders includes an inlet opening (inlet port), fluidly connecting the bladder to a respective conduit, which is configured to deliver fluid from a proximal region (in particular, via the inflation mechanism, as detailed above). In the cross section illustrated in Fig. 4A, inlet 414C of bladder 410C, which is connected to fluid conduit 460 is shown. It is noted that the inlet openings of bladders 410A-B are not shown in the illustrated cross section. In addition to an inlet port, each of the bladders includes an outlet opening (also referred to herein as pressure release opening), which is configured to allow the release of pressure (by fluid removal) from the bladder. Shown in Fig. 4A are outlet openings 440A-C, of bladders 410A-C, respectively. The outlet opening of each bladder is fluidly connected to fluid release (or pressure release) conduit (such as conduit 450), which may be common to all bladders. In some embodiments, the pressure release conduit may be connected at a more proximal region of the device to adaptors / connectors / valves (such as connectors 108 shown in Fig. 1A)., allowing the controlled release of pressure (by fluid drainage) from the bladders. Additionally, as detailed above, at the region of distal tip 412, blood drainage openings 424A-B are shown. Blood drainage openings 424A-B allows the draining / sampling of blood from the wound area to be conveyed to a proximal region, for allowing hemorrhage visualization by a user, at the proximal, external region. This allows tracking the efficiency of the device in controlling hemorrhage, and in particular, to determine if additional pressure is needed to be exerted.

[0095] Reference is now made to Fig. 4B, which shows a cross section side view of a segmented, deflated balloon, at the distal region of an adjustable tourniquet device, according to some embodiments. Shown in Fig. 4B is segmented balloon 452 having three segmented bladders, 460A-C, which are shown in full deflated state, disposed along the distal region of catheter body 450. Further shown is guidewire 462, allowing the passing of the catheter body into the body of the subject, to facilitate the positioning of distal end 472 thereof in the target region (e.g., wound site).

[0096] According to some embodiments, the bladders (segments of the balloon) may be similar or different with respect of size, dimension, form, and the like. In some embodiments, the bladders are identical. In some embodiments, the size and / or shape of the balloon may be adjusted to the site of injury, type of injury, body part, and the like. In some embodiments, each two consecutive bladders may be similar or different. In some embodiments, the threshold pressure of each bladder (i.e., the internal pressure in the bladder, which would induce the inflation of a sequential bladder) may be predetermined. In some embodiments, the threshold pressure may be similar or different between bladders. In some embodiments, the determination of the threshold pressure for each bladder may be determined for each device a priori, or may be adjusted before or during use. In some embodiments, the threshold pressure may be determined according to the site of injury, type of injury, body part, and the like. In some embodiments, a threshold pressure for each bladder may be calibrated during manufacturing of the balloon, the device and / or the inflation mechanism. In some embodiments, the adjustment of the threshold pressure may be facilitated by adjusting the configuration of valves in the inflation mechanism. In some embodiments, the threshold pressure in the bladders may be, for example, in the range of about 60-150mmHg, or any sub range thereof, for example, about 80-140mmHg, about 90-130mmH, about 100-120mmHg, about 105-115mmHg, about HOmmHg.

[0097] In some embodiments, the inner threshold pressure is related (or determined by) a threshold inner volume of the bladder. In some embodiments, a threshold volume of each bladder (i.e., the internal volume in the bladder, which would induce the inflation of a sequential bladder) may be predetermined. In some embodiments, the threshold volume may be similar or different between bladders. In some embodiments, the determination of the threshold volume for each bladder may be determined for each device a priori, or may be adjusted before or during use. In some embodiments, the threshold volume may be determined according to the site of injury, type of injury, body part, and the like. In some embodiments, a threshold volume for each bladder may be calibrated during manufacturing of the balloon, the device and / or the inflation mechanism. In some embodiments, the adjustment of the threshold volume may be facilitated by adjusting the configuration of valves in the inflation mechanism. In some embodiments, the threshold volume in the bladders may be, for example, in the range of about 10- 100ml, or any sub range thereof, for example, about 20-90ml, about 30-70ml, about 40-60ml.

[0098] In some embodiments, the balloon may be made of any suitable biocompatible materials, such as, for example, but not limited to: polyethylene (PE), ethylene-vinyl acetate (EVA), polyvinyl chloride (PVC), thermoplastic polyurethane (TPU), latex, biocompatible rubber, Poly etheretherketone (PEEK), Polyamide (PA), Teflon (PTFE), Polypropylene (PP), Polyethylene terephthalate (PET), Silicone, Polyurethane (PU), Thermoplastic elastomers (TPE), or any combinations thereof. Each possibility is a separate embodiment. In some exemplary embodiments, the balloon may be made of silicone.

[0099] In some embodiments, the walls of the bladders may have a thickness in the range of about 0.25-1.25mm, e.g., 0.5-lmm, or any subranges thereof. Each possibility is a separate embodiment. In some embodiments, the elasticity of the bladders may be in the range of about 20-100 Shore, e.g. 30-80 shore, or any subranges thereof. Each possibility is a separate embodiment. In some embodiments, the length of the bladders may be in the range of about 20- 120mm, for example, about 30-80mm, about 40-60mm, or any subranges thereof. Each possibility is a separate embodiment. In some embodiments, the diameter of a deflated bladder may be in the range of about 0.2-2mm or any subranges thereof, for example, about 0.5-lmm, about 0.8-0.9 mm. In some embodiments, the diameter of an inflated bladder may be in the range of about 2-80mm, for example, or any subranges thereof. Each possibility is a separate embodiment. As detailed herein, the bladders may be identical, similar or different with respect of shape, size, diameter, thickness, volume, length, etc. In some embodiments, the bladders may be tapered in size along the longitudinal axis to match anatomical tapering.

[0100] In some embodiments, the segmented balloon may be manufactured by any method known in the art. In some embodiments, the walls of the ballon may be mechanically, chemically and / or physically reinforced. Such reinforcement may include, for example, but not limited to: inclusion of supporting fibers, inclusion of an outer surrounding supporting layer, and the like. In some embodiments, the balloon may optionally be wrapped in a crisscross layer configuration, limiting inflation capacity and serving as an actuator for the sequential segment inflation.

[0101] According to some embodiments, the balloon may be coated with or include one or more medical substances, which are related to the injury and may enhance treatment. Such substances may include, for example, coagulation substances, antiseptic substances, antibiotics, analgesic substances, biological glue, and the like, or any combination thereof. Each possibility is a sperate embodiment. In some embodiments, as each bladder inflates, controlled or uncontrolled release of such medical substances may be facilitated. In some embodiments, such substances may be integrated within the balloon structure or deployed within the invaginations of the balloon. In some embodiments, the substances may be encapsulated or held in corresponding vehicles, which may be associated with the balloon (for example, coating at least some of the external walls of the balloon), wherein the vehicles are configured to release the substances according to one or more ques, such as, pressure changes, physiological condition in the tissue, and the like.

[0102] According to some embodiments, the balloon my further include one or more anchoring means, such as anchoring hooks, that can be used to secure the device within the tissue and prevent unwanted dislodgement thereof. In some embodiments, the anchoring means may be attached to the balloon or may be formed as integral part thereof.

[0103] Reference is now made to Fig. 5, which shows schematic views of an adjustable tourniquet device, at various states of inflation, according to some embodiments. Fig. 5 illustrates sequential inflation of bladders 510A-C of device 500. In initial stage I, device 500 is at an initial position, wherein bladders 510A-C are deflated. Once fluid is introduced to device 500 (via inflation mechanism 520), as shown in stage II, the fluid is directed to first (distal) bladder 510A, which is inflated until reaching a threshold pressure to assume inflated state 510A’. Once reaching the threshold pressure, fluid is allowed to enter consecutive bladder 510B. If fluid is continued to be introduced to device 500, bladder 500B is inflated, up until reaching a threshold pressure, to assume inflated state 500B’ as shown in stage III. Once reaching the threshold pressure, fluid is allowed to enter consecutive bladder 510C. If fluid is continued to be introduced to device 500, bladder 500C is inflated, up util reaching a threshold pressure, to assume inflated state 500C’ as shown in stage IV. Accordingly, by continuously introducing fluid to the d evice, the bladders sequentially inflate. It is noted that the inflation of the bladders maybe halted at any stage, in accordance with the clinical condition. For example, a first bladder may be fully inflated (i.e. reaching the threshold pressure), while the consequent bladder is not fully inflated (for example, it is inflated to a range of 10-90% of the threshold pressure).

[0104] According to some embodiments, by controlling such sequential inflation of the segmented balloon, varying amount of pressure may be maintained along the wound tract, thereby enhancing efficiency and safety of the tourniquet device.

[0105] According to some embodiments, the control of the sequential inflation may be facilitated by controlling the amount, pressure and / or frequency of fluid introduced into the device. To this aim, an inflation unit, which may be reversibly or permanently- associated with the proximal end of the inflation mechanism may be utilized. Such inflation unit is configured to provide requested amounts of fluid with each cycle of operation thereof. In some embodiments, the operation is manual (for example, by manually pressing or holding a hand pump or syringe). In some embodiments, the operation is automatic (for example, using an actuator). In some embodiments, the inflation unit is re-usable. In some embodiments, the inflation unit is disposable. In some embodiments, the inflation unit is in the form of a foldable, elastic pump, allowing enhanced portability and flexibility. In some embodiments, the inflation unit is in the form of a syringe. In some embodiments, the amount of fluid introduced with each operation / activation of the inflation unit may be, for example, about 10-80 ml, or any sub ranges thereof) for example, about 20-70ml, about 25-60 ml, 30-50 ml or 35-45 ml.

[0106] According to some embodiments, bladders of the balloon may include one or more pressure sensors, that may be utilized for distributing pressure within and / or between bladders.

[0107] According to some embodiments, there is provided herein an adjustable tourniquet system, which includes an adjustable tourniquet device, an inflation mechanism and an inflation unit.

[0108] Reference is now made to Fig. 6A, which shows a schematic view of an adjustable tourniquet system including an adjustable tourniquet device and an inflation unit, according to some embodiments. As shown in Fig. 6A, system 610 includes a tourniquet device 600, having a segmented balloon 602 at a distal region thereof and an inflation mechanism 620, at a proximal region thereof. In addition, system 610 includes an inflation unit 630, which is configured to connect to the distal end of the inflation mechanism. Inflation unit 630 is configured to provide designated amount of fluid to the inflation mechanism, with operation thereof. Inflation unit 630 may include, for example, a pump (such as handheld pump 632), a bag, such as a liquid bag (634), an actuator, a syringe, and the like. In some embodiments, the inflation unit may be connected, via a connector (such as, a Luer connector), to the distal end to the inflation mechanism, to form a continuous fluid connection therebetween. The inflation unit and / or the inflation mechanism may be connected to the device and / or thereto, via one or more adapters or connectors.

[0109] Reference is made to Fig. 6B showing a schematic view of an adjustable tourniquet system including an adjustable tourniquet device and an inflation unit, according to some embodiments. As shown in Fig. 6B, system 650 includes a tourniquet device 652, having a segmented balloon 684 at a distal region thereof and an inflation mechanism 686, at a proximal region thereof. In addition, system 680 includes an inflation unit 690, which is configured to connect to the distal end of the inflation mechanism. Inflation unit 660 is configured to provide designated amount of fluid to the inflation mechanism, with operation thereof. Inflation unit 660 may include, for example, a pump (such as handheld pump 662), a bag, such as a liquid bag (664), an actuator, a syringe, and the like. In some embodiments, the inflation unit may be connected, via a connector (such as, a Luer connector), to the distal end to the inflation mechanism, to form a continuous fluid connection therebetween. The inflation unit and / or the inflation mechanism may be connected to the device and / or thereto, via one or more adapters or connectors.

[0110] According to some embodiments, the system may further optionally include one or more sensors. In some embodiments, such sensors may include, for example, but not limited to: pressure sensors, thermometer, a flow sensor, and the like. Such sensors may be associated with the elongated body, the balloon, the inflation mechanism and / or the inflation unit. In some embodiments, the system may further optionally include external control unit used for adjusting the balloon size.

[0111] Reference is now made to Fig. 7, which shows a schematic view of an adjustable tourniquet system positioned at a site of internal injury, according to some embodiments. Shown in Fig. 7 is injury site 730, on limb 710. Into the tract wound, tourniquet device 700 of system 750 is inserted. Once the distal end of the device is positioned in (or in close proximity) to the injury site, using inflation unit 760 of system 750, fluid (such as, air, gas or liquid) is introduced into inflation mechanism 770. Inflation mechanism 770 directs the introduced fluid to the segmented balloon 702 of the device, to enable sequential inflation of the balloon. Once the balloon has been inflated (702’) to a level which exerts sufficient pressure on the wound site and blood hemorrhage has been reduced or halted, no additional fluid is needed to be introduced to the balloon. Accordingly, by using the tourniquet system, effective hemorrhage control is achieved.

[0112] According to some embodiments, the device is single-use and sterile. In some embodiments, the device may be deployed by healthcare practitioners via the wound tract using a guide wire (for example made of silicone), enabling placement / positioning close to the bleeding vessel. In some embodiments, the tourniquet device may include three inflatable bladders having length of about 40, 60 and 60 mm (distal to proximal bladers, respectively). Upon fluid insertion (for example, by manual pumping), the distal balloon inflates first to apply direct pressure and seal the injured vessel. If bleeding persists, the operator may continue inflating the device and activating adjacent balloon segments sequentially. Once bleeding is controlled and upon arrival at a point of care (e.g., hospital), the balloon may be deflated, and the tourniquet device may be removed.

[0113] According to some embodiments, the device may be in the length of between about 4 and 22 cm, having a flexible, biocompatible silicone shaft equipped with an inflatable balloon having three inflatable chambers having a length of about 30-80mm (e.g., 40 mm, 50 mm, 60 mm).

[0114] Reference is now made to Fig. 8, which shows a block diagram of steps in a method for using an internal tourniquet system, according to some embodiments. As shown in Fig. 8, method 800 includes at step 810 providing or obtaining an internal adjustable tourniquet system, which includes the tourniquet device, the inflation mechanism and / or inflation unit. At step 820, the distal end of the device is inserted to the site of injury. In some embodiments, the insertion may be performed along the tract wound. In some embodiments, the insertion / guidance may be made thought a surrounding tissue. In some embodiments, the insertion may be aided using a guidewire and / or an insertion tube. In some embodiments, the device is inserted such that the distal tip and distal end of the device is located in or in close proximity to the wound site. Next, at step 830, fluid is provided to the segmented internal balloon, such that a distal bladder is capable of being inflated. The introduction of fluid is performed manually, using the inflation unit which provides portions of fluids at designated amount (and optionally at designated pressure). Next, at step 840, if the distal bladder internal pressure reaches a threshold level, the inflation mechanism is configured to direct additional fluid introduced thereto, to a consequent sequential bladder. The inflation sequence is repeated, until sufficient pressure is applied on the site of injury, to at least partially restrict blood flow therefrom. In some embodiments, the inflation sequence is repeated until blood flow has stopped. In some embodiments, the inflation is halted, when blood flow has stopped (even if only the first bladder is partially inflated (i.e., has not reached a pressure threshold)). In some embodiments, the method may further include the optional steps of associating the device with the inflation mechanism (if not integrated therewith a-priori), associating the inflation mechanism with an inflation unit, and the like. In some embodiments, the method may further include steps of visualizing blood flow, from the blood drainage conduit. In some embodiments, the method may further include the step of anchoring the device to the tissue, after insertion. In some embodiments, the method may further include the step of providing or allowing medical substances to be dispersed in the tissue. In some embodiments, the method may further include a step of releasing fluid from the balloon, to allow removal of the device from the tissue.

[0115] According to some embodiments, in order to prevent tissue damage, the tourniquet device may be removed from the wound region after a designated period of time, such as, for example, 2-4 hours, depending, for example, on the site of wound, injured tissue, severity of injury, etc. In some embodiments, The pressure exerted by the device may intermittently be at least partially released / reduced, in order to reduce of prevent tissue damage. For example, the pressure exerted may be reduced for a period of 5-10 minutes every hour. In some embodiments, the reduction in pressure may be performed manually, semi -automatically or automatically.

[0116] According to some embodiments, there is provided a use of the device or system as disclosed herein for controlling traumatic hemorrhage from a penetrating wound.

[0117] According to some embodiments, there is provided a device as disclosed herein for use in a method of controlling traumatic hemorrhage from a penetrating wound, the method includes inserting the device into the wound site; providing fluid to the segmented balloon to facilitate sequential inflation of the bladders; and monitoring blood drainage from the wound.

[0118] According to some embodiments, there is provided a kit for controlling traumatic hemorrhage from a penetrating wound, the kit includes the tourniquet device as disclosed herein having an inflation mechanism and / or an inflation unit. In some embodiments, the kit may be provided in a sterile pack.

[0119] It is appreciated that certain features of the disclosure, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the disclosure, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment of the disclosure. No feature described in the context of an embodiment is to be considered an essential feature of that embodiment, unless explicitly specified as such.

[0120] As used herein, the indefinite articles “a” and “an” mean “at least one” or “one or more” unless the context clearly dictates otherwise.

[0121] Although the disclosure is described in conjunction with specific embodiments thereof, it is evident that numerous alternatives, modifications and variations that are apparent to those skilled in the art may exist. Accordingly, the disclosure embraces all such alternatives, modifications and variations that fall within the scope of the appended claims. It is to be understood that the disclosure is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth herein. Other embodiments may be practiced, and an embodiment may be carried out in various ways.

[0122] The phraseology and terminology employed herein are for descriptive purpose and should not be regarded as limiting. Citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the disclosure. Section headings are used herein to ease understanding of the specification and should not be construed as necessarily limiting.

[0123] As used herein, the term “about” may be used to specify a value of a quantity or parameter (e.g., the length of an element) to within a continuous range of values in the neighborhood of (and including) a given (stated) value. According to some embodiments, “about” may specify the value of a parameter to be between 80 % and 120 % of the given value. According to some embodiments, “about” may specify the value of a parameter to be between 90 % and 110 % of the given value. According to some embodiments, “about” may specify the value of a parameter to be between 95 % and 105 % of the given value.

[0124] In the description and claims of the application, each of the words “comprise” “include” and “have”, and forms thereof, are not necessarily limited to members in a list with which the words may be associated.

[0125] In the description and claims of the application the expression “at least one of A and B”, (e.g. wherein A and B are elements, method steps, claim limitations, etc.) is equivalent to “only A, only B, or both A and B”. In particular, the expressions “at least one of A and B”, “at least one of A or B”, “one or more of A and B”, and “one or more of A or B” are interchangeable.

[0126] Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range. Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases “ranging / ranges between” a first indicate number and a second indicate number and “ranging / ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.

[0127] It is appreciated that certain features of the disclosure, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the disclosure, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment of the disclosure. No feature described in the context of an embodiment is to be considered an essential feature of that embodiment, unless explicitly specified as such.

[0128] Although steps of methods according to some embodiments may be described in a specific sequence, methods of the disclosure may include some or all of the described steps carried out in a different order. A method of the disclosure may include a few of the steps described or all of the steps described. No particular step in a disclosed method is to be considered an essential step of that method, unless explicitly specified as such.

[0129] The phraseology and terminology employed herein are for descriptive purpose and should not be regarded as limiting. Citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the disclosure. Section headings are used herein to ease understanding of the specification and should not be construed as necessarily limiting.

Claims

CLAIMSWhat is claimed is:

1. An internal adjustable tourniquet device for controlling traumatic hemorrhage from a penetrating wound, the device comprising: a flexible elongated body having a distal end configured for insertion into the wound; and an inflatabl e segmented balloon di sposed along the l ength of the distal portion of the elongated body, wherein the inflatable segmented balloon comprises a plurality of sequential bladders, each of the bladders is in fluid communication with the elongated body; wherein the bladders are configured to inflate sequentially, in a distal to proximal direction, such that, only when a distal bladder is inflated to an internal threshold pressure, a sequential proximal bladder is capable of being inflated, thereby maintaining sufficient pressure on or along the wound and at least partially- reducing or halting hemorrhage from the wound.

2. The device according to claim 1, wherein the threshold pressure is predetermined, and is essentially similar between two or more the bladders.

3. The device according to claim 1 or 2, wherein each two sequential bladders are similar, identical or different with respect of size and / or shape.

4. The device according to any one of claims 1-3, wherein the walls of the balloon are made of polyethylene (PE), ethylene-vinyl acetate (EVA), polyvinyl chloride (PVC), thermoplastic polyurethane (TPU), latex, biocompatible rubber, Polyetheretherketone (PEEK), Polyamide (PA), Teflon (PTFE), Polypropylene (PP), Polyethylene terephthalate (PET), Silicone, Polyurethane (PU), Thermoplastic elastomers (TPE), or any combinations thereof.

5. The device according to any one of claims 1 -4, wherein each bladder comprises an inlet, allowing fluid to be inserted thereto, and an outlet configured to allow releasing of fluid from the bladder.

6. The device according to any one of claims 1-5, comprising at a proximal end thereof one or more fluid inlets.

7. The device according to any one of claims 1-6, comprising, at a proximal region thereof an inflating mechanism comprising one or more valves, configured to control fluid flow to a respective bladder.

8. The device according to claim 7, comprising a plurality of valves arranged linearly, thereby enabling sequential inflation of the segmented bladders, according to a predetermined distal to proximal order.

9. The device according to claim 7, comprising a plurality of valves comprising parallelly arranged check-valves having varying pressure thresholds, enabling the sequential inflation of the segmented bladders.

10. The device according to any one of claims 8-9, wherein each control valve is fluidly connected to a respective bladder, via a respective fluid conduit.

11. The device according to any one of claims 1-7, wherein the inflation mechanism further comprises a selector and / or an inlet fluid connector.

12. The device according to any one of claims 1-11, further comprising a blood drainage lumen.

13. The device according to claim 12, wherein the blood drainage lumen is configured to drain blood from the hemorrhage region to a proximal region of the device, thereby enabling visualization of blood flow at the proximal region of the device.

14. The device according to any one of claims 1-13, further comprising one or more pressure release valves, configured to release pressure in the bladder.

15. The device according to any one of claims 1-14, further comprising an anchoring member, configured to anchor the device after being positioned in the wound.

16. The device according to any one of claims 1-15, wherein the balloon comprises or is coated with one or more medical substances.

17. The device according to claim 16, wherein the medical substances comprise procoagulation substances, antiseptic substances, antibiotics, analgesic substances, biological glue, or any combination thereof.

18. The device according to any one of claims 1-17, further comprising a guide wire, configured to aid in inserting / aiming the device into the tract wound.

19. The device according to any one of claims 1-18, comprising an atraumatic distal tip.

20. The device according to any one of claims 1-19, wherein the wound is a tract wound and the device is at least partially inserted along the wound tract.

21. The device according to claim 20, wherein the blood vessel is located in a limb, shoulder, neck, abdomen, pelvic, armpit, or any combinations thereof.

22. A system for controlling traumatic hemorrhage from a penetrating wound, the system comprising the device according to any one of claims 1-19; and an inflation unit configured to connect to the proximal end of the device and provide fluid to an inflation mechanism associated with the device.

23. The system according to claim 22, wherein the inflation unit is configured to connect to an inflation mechanism of the device.

24. The system according to any one of claims 22-23, wherein the inflation unit comprises a pump, a bag, a syringe, an actuator, or any combinations thereof.

25. The system according to any one of claims 22-24, wherein the fluid comprises air, gas and / or liquid.

26. The system according to any one of claims 22-25, wherein the fluid provided by the inflation unit is pressurized fluid.

27. The system according to any one of claims 22-26, wherein the inflation unit is configured to deliver a designated volume of fluid, for every cycle of operation thereof.

28. The system according to any one of claims 22-27, wherein the inflation unit is reversibly associated with the device.

29. The system according to any one of claims 22-27, wherein the inflation unit is permanently associated or is integrally formed with the device.

30. The system according to any one of claims 22-29, wherein the inflation unit is operated manually.

31. The system according to any one of claims 22-30, wherein the inflation unit is operated semi -automatically or automatically.

32. The system according to any one of claims 22-31, wherein the inflation unit is disposable.

33. The system according to any one of claims 22-32, wherein the inflation unit is reusable.

34. A method for controlling traumatic hemorrhage from a penetrating wound, the method comprising: inserting the device according to any one of claims 1-21, or the system according to any one of claim s 22-33, to the wound site; providing fluid to the segmented balloon, to facilitate sequential inflation of the bladders, until sufficient pressure is achieved; and monitoring blood drainage from the wound,35. The method according to claim 34, further comprising anchoring the device once inserted into the wound site.

36. The method according to any one of claims 34-35, further comprising allowing application of medical substances to or in close proximity to the wound site.

37. The method according to claims 34-36, further comprising removing fluid from inflated bladders, thereby deflating the bladders and allowing removal of the device from the wound site.

38. The method according to claims 34-37, further comprising connecting an inflation unit to the proximal end of the device, prior to, during or after inserting the device to the wound site.

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