Trans-esophageal aortic flow rate control

Abstract

A trans-esophageal aortic flow control device includes an esophageal tube, an anchoring device for securing placement in a patient's stomach, and an articulating actuator. The articulating actuator includes a carrier extending through the esophageal tube, at least one movable arm connected to the carrier, a compression balloon mounted on the movable arm, and a mechanical operator. The mechanical operator is configured to move the movable arm between a stored position within the esophageal tube and a deployed position extending outward from the esophageal tube to position the compression balloon to apply a compressive force posteriorly in the patient's esophagus against their aorta. The movable arm may comprise a pivotable arm that pivots through an opening in the tube wall, a curving articulable arm that bends outward from the tube, or a multi-pivot assembly having first and second pivoting arms connected by a compression balloon carrier. The articulating actuator is positioned to align the compression balloon with the patient's aorta proximal to their diaphragm when deployed.

Description

[0001] TRANS-ESOPHAGEAL AORTIC FLOW RATE CONTROL

[0002] STATEMENT OF GOVERNMENT INTEREST

[0003] This invention was made with government support under Grant Number W81XWH-22-1- 0037 awarded by the Defense Health Agency, Medical Research and Development Branch. The government has certain rights in the invention.

[0004] FIELD OF THE INVENTION

[0005] The present invention relates generally to methods and apparatus for the treatment of hemorrhaging, and more particularly to methods and apparatus for minimally invasive control of aortic blood pressure to mitigate hemorrhaging, and particularly non-compressible abdominal hemorrhaging.

[0006] BACKGROUND

[0007] Hemorrhage is a leading cause of death and severe morbidity in the United States and throughout the world. The most common cause of such mortality is trauma. In fact, non- compressible abdominal wound hemorrhage is one of the leading causes of preventable death in both civilian and military trauma patients. In trauma injuries, most early deaths are caused by hemorrhage, and according to studies occur at a median of 2.6 hours after admission. Additionally, hemorrhage is responsible for 40% of civilian trauma-related deaths, and for more than 90% of military deaths that result from otherwise potentially survivable injuries. According to some professionals, about 67.3% of deaths on the battlefield are the result of hemorrhage from a wound to the truncal area. Although there are many devices developed that stop hemorrhage, many of them are not sufficient to stop internal bleeding in certain areas, such as the abdomen. While direct pressure and tourniquets to manage bleeding from extremity injuries has significantly improved survival, internal hemorrhage within the chest, abdomen and pelvis is not easily accessible and often will continue to bleed. Uncontrolled bleeding in the torso is referred to as non-compressible torso hemorrhage (NCTH), is not amenable to control via direct pressure, and frequently leads to hemorrhagic shock and death. There are limited clinical options to treat NCTH, with emergent surgical intervention being the best option. Studies of U.S. casualties during the wars in Iraq and Afghanistan and of civilian trauma patients confirmed that hemorrhage remained the leading cause of preventable death. Recent studies estimated that 50% of early trauma deaths were due to NCTH. In military settings nearly 90% of potentially preventable pre-hospital battlefield deaths were due to hemorrhage, while nearly 70% of those preventable deaths were caused by exsanguination from truncal injuries. A study on tourniquet use in combat injuries reported 90% survival when the hemorrhage was controlled prior to the onset of shock vs 0% when an appropriate tourniquet was never applied. Multiple studies on civilian trauma have also shown the high risk of early mortality from severe hemorrhage and the critical need for early bleeding control to prevent shock and reduce the risk of death. One study conducted showed that 31% of patients suffering from NCTH and hemorrhagic shock died within 2 hours after emergency department arrival, while an additional 12% died within the first 24 hours and 11% of such hemorrhagic shock patients died after 24 hours. Among those surviving, 39% developed infection and 24% developed organ failure. In civilian trauma earlier hemorrhage control was also associated with improved survival including a 6-fold decrease in mortality with appropriate tourniquet utilization. The critical finding is that early hemorrhage control reduces blood loss and saves lives. Unfortunately, a tourniquet cannot be applied to effectively control NCTH. The ability to control such inaccessible internal bleeding would, however, provide critical time needed to get a patient to an operating room for a life-saving surgical procedure and is an unmet clinical need.

[0008] There are a number of preexisting devices that attempt to tackle this issue but fall short of fulfilling the desired outcome. Many such devices are largely theoretical, such as the chemical expanding foam RESQFOAM (available from Arsenal Medical), which describes a chemical compound that is inserted into the wound site itself and then expands to take up the entire abdominal cavity, thus putting pressure on the damaged tissue. However, the inserted foam is not biodegradable and must be completely surgically removed prior to the surgeon sewing up the wound. This process can easily result in complications and, thus, should be avoided.

[0009] Still other devices, such as the Abdominal Aortic and Junctional Tourniquet (AAJT), are only capable of preventing blood loss in juncture and not in abdominal wounds. An AAJT places pressure around the wounded area using a large belt-like device that is fastened. While this device has been implemented to a limited extent, the AAJT has only seen real success in stopping junctural hemorrhages and not abdominal hemorrhages. Therefore, it does not do an adequate job at stopping abdominal hemorrhaging. Thus, a device and method are still required to be effective in this area and to be deployed in emergency medicine.

[0010] The most successful and prevalent device on the market currently is the REBOA catheter that is capable of consistently preventing blood loss, which essentially comprises a small gastric balloon attached to a guide wire that is inserted into the femoral artery in the thigh and then snaked up to the descending aorta where the balloon is then inflated. This process decreases the flow rate to the abdomen and thus prevents bleeding. However, because of the invasive nature of the device and its insertion into the body, the procedure can only be implemented by a surgeon in a sterile operating room, and requires time that trauma patients often do not have.

[0011] As indicated by the foregoing prior efforts, unlike wounds to the extremities, normal methods of treatment to stop bleeding such as simple compression or tourniquets are simply ineffective in abdominal wounds. These wounds often involve internal bleeding and organ damage, such that applying pressure does not reach the internal wound. Therefore, there remains a need for improved methods and devices capable of decreasing the number of preventable deaths from abdominal hemorrhage, and more particularly that are minimally invasive, that are capable of preventing flow rather than pressure the wound directly, and that may readily be used and inserted into a patient by emergency services personnel in the field.

[0012] SUMMARY OF THE INVENTION

[0013] Disclosed herein are relatively non-invasive methods and apparatus that, with respect to certain features of an embodiment of the invention, may resolve at least some of the foregoing problems. The methods and apparatus according to certain aspects of an embodiment are configured to be easily inserted into a patient’s esophagus in order to apply posterior pressure to the patient’s aorta. The applied pressure from the device results in the impingement or occlusion of the aorta, such that blood flow is significantly reduced if not eliminated in the lower portion of the body, including the abdomen. This allows medical professionals to extend the life of a patient while the wound is repaired. The device and its method of use are sufficiently simple so as to not require that it be administered by a surgeon, and thus can be used by many health professionals.

[0014] A device configured in accordance with certain aspects of an embodiment can be used by a wider range of medical personnel than previously known abdominal hemorrhage control devices due to its ease of use and non-invasiveness. This allows for using the device in locations other than operating rooms. There are many patients that could benefit from a device configured in accordance with such aspects of the invention, such as soldiers in the battlefield or patients admitted to hospitals due to injuries related to gunshots or stabbing.

[0015] A device according to certain aspects of an embodiment includes an esophageal tube and an actuator. In certain configurations, at least a portion of the actuator may be situated in a sleeve. In certain configurations, the device may include an anchor-like component, such as at least one balloon (e.g., a gastric balloon) to secure placement of the actuator and / or esophageal tube within the patient.

[0016] In accordance with certain aspects of an embodiment, a trans-esophageal aortic flow control device and method may be provided offering a portable assembly that offers a low risk safety profile with high efficacy and life-saving capabilities compared to typical devices. The device may be used by nurses, medics, and field personnel at the site of injury in pre-hospital or pre-operative settings. The device may enable many additional personnel to rapidly intervene, start resuscitation and control catastrophic bleeding earlier in forward field positions and in hospitals prior to surgical hemostasis. Such a lightweight and portable therapeutic device for early intervention by an increased number of providers to control NCTH can support those in austere environments, such as the warfighter on or near the battlefield, to reduce the number of preventable deaths resulting from hemorrhage.

[0017] In certain configurations, the device comprises a controller, an esophageal tube extending from the controller, an anchor device at a distal end of the esophageal tube and configured to anchor the distal end of the device inside a patient’s stomach, and an actuator positioned proximally to the anchoring device by a sufficient distance so that the actuator will be proximal to the intersection of the patient’s esophagus with their diaphragm when the anchoring device is positioned inside of the patient’s stomach. In this position, the anchoring device is aligned with the location at which the patient’s esophagus and aorta cross that is above (and proximal to) the intersection with the patient’s diaphragm, with the patient’s aorta then positioned between the spine and the esophagus. Thus, when the actuator is engaged, a compressive force is applied by the actuator against the interior of the patient’s esophagus and, in turn, upon their underlying aorta so as to significantly occlude blood flow through their aorta and reduce the risk of lethal hemorrhaging from an abdominal wound.

[0018] In accordance with still further aspects of an embodiment, a device for trans-esophageal aortic flow control is disclosed, comprising: an esophageal tube having a distal end and a proximal end; an anchoring device adjacent the distal end of the esophageal tube and configured to secure placement of the distal end of the esophageal tube in a patient’s stomach; and an actuator configured to apply a compressive force posteriorly in the patient’s esophagus in a direction of the patient’s aorta at a location in the patient’s aorta that is proximal to the patient’s diaphragm to at least partially occlude the patient’s aorta at that location.

[0019] In accordance with still further aspects of an embodiment, a device for trans-esophageal aortic flow control is provided, comprising: an esophageal tube having a distal end and a proximal end; an anchoring device adjacent the distal end of the esophageal tube and configured to secure placement of the distal end of the esophageal tube in a patient’s stomach; and an actuator configured to apply a compressive force posteriorly in the patient’s esophagus in a direction of the patient’s aorta, wherein the actuator is positioned on the esophageal tube proximally to the anchoring device by a sufficient distance to cause the actuator to be aligned with a portion of the patient’s esophagus that is distal to an intersection of the patient’s esophagus and the patient’s diaphragm when the anchoring device is positioned inside of the patient’s stomach.

[0020] In accordance with still yet further aspects of an embodiment of the invention, a method for trans-esophageal aortic flow control is provided, comprising: providing a trans-esophageal aortic flow control device comprising an esophageal tube having a distal end and a proximal end, an anchoring device adjacent the distal end of the esophageal tube and configured to secure placement of the distal end of the esophageal tube in a patient’s stomach, and an actuator configured to apply a compressive force posteriorly in the patient’s esophagus in a direction of the patient’s aorta at a location in the patient’s aorta that is proximal to the patient’s diaphragm to at least partially occlude the patient’s aorta at that location; inflating the anchoring device inside of the patient’s stomach; and extending the actuator from the esophageal tube to contact the interior of the patient’s esophagus so as to compress the patient’s aorta at a location that is distal to the patient’s diaphragm.

[0021] In accordance with certain aspects of a particularly preferred embodiment, the actuator may comprise a balloon that may be carried inside of the esophageal tube and an articulating arm that may be remotely operated by, for example, a mechanical operator such as a wire, such that pulling the wire causes the articulating arm to move so as to position a compression balloon that is affixed to the actuator against the patient’s esophagus. In this deployed position, upon inflation of the compression balloon, the compression balloon pushes the patient’s esophagus against the patient’s aorta at a location that is distal to the patient’s diaphragm, thus restricting blood flow through the patient’s aorta.

[0022] Still other aspects, features and advantages of the invention are readily apparent from the following detailed description, simply by illustrating a number of particular embodiments and implementations, including the best mode contemplated for carrying out the invention. The invention is also capable of other and different embodiments, and its several details can be modified in various obvious respects, all without departing from the spirit and scope of the invention. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.

[0023] BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized. The present invention is illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings, in which like reference numerals refer to similar elements, and in which:

[0025] FIG. 1 is an anatomical drawing indicating the typical position of a human esophagus, aorta, and spine.

[0026] FIG. 2 is a drawing of a gastric balloon that may be used to ensure proper placement of a device as described herein and provide lateral stability.

[0027] FIG. 3 is a schematic view of a trans-esophageal aortic flow control device for occluding a patient’s aorta in accordance with certain aspects of an embodiment of the invention.

[0028] FIG. 4 is a side perspective view of a distal end of the trans-esophageal aortic flow control device of FIG. 3 according to further aspects of an embodiment of the invention.

[0029] FIG. 5 is a side perspective view of a distal end of the trans-esophageal aortic flow control device of FIG. 3 according to still further aspects of an embodiment of the invention.

[0030] FIG. 6 is a cross-sectional view of the trans-esophageal aortic flow control device of FIG. 3.

[0031] FIG. 7 is a side partial sectional view of the trans-esophageal aortic flow control device of FIG. 3.

[0032] FIG. 8 is a side perspective view of a section of the trans-esophageal aortic flow control device of FIG. 3 according to still further aspects of an embodiment of the invention and including a deployed covering positioned over a compression balloon.

[0033] FIG. 9 is a side perspective view of the section of the trans-esophageal aortic flow control device of FIG. 8 in which the covering is in a collapsed position.

[0034] FIGs. 10(a), 10(b), and 10(c) are schematic views of a wire fin being deployed from the trans-esophageal aortic flow control device of FIG. 3 in accordance with further aspects of the invention.

[0035] FIG. 11 is a side schematic view of wire fins being deployed from the trans-esophageal aortic flow control device of FIG. 3 in accordance with further aspects of the invention.

[0036] FIG. 12 is a perspective view of an internal shaft of an esophageal tube for use in the device of FIG. 3 and in accordance with still further aspects of the invention.

[0037] FIG. 13 is a cross-sectional view of the internal shaft of FIG. 12.

[0038] FIGs. 14(a) and 14(b) are top and bottom perspective views, respectively, of a bending base element for use in the internal shaft of FIG. 12.

[0039] FIGs. 15(a) and 15(b) are top and bottom perspective views, respectively, of a transition element for use in the internal shaft of FIG. 12.

[0040] FIGs. 16(a) and 16(b) are top and bottom perspective views, respectively, of a curved element for use in the internal shaft of FIG. 12.

[0041] FIGs. 17(a) and 17(b) are top and bottom perspective views, respectively, of a rigid shaft element for use in the internal shaft of FIG. 12.

[0042] FIGs. 18(a) and 18(b) are side cross-sectional views of a trans-esophageal aortic flow control device in a stored and deployed position, respectively, in accordance with certain aspects of an embodiment of the invention.

[0043] FIGs. 19(a) and 19(b) are side cross-sectional views of a trans-esophageal aortic flow control device in a stored and deployed position, respectively, in accordance with further aspects of an embodiment of the invention.

[0044] FIGs. 20(a) and 20(b) are side cross-sectional views of a trans-esophageal aortic flow control device in a stored and deployed position, respectively, in accordance with still further aspects of an embodiment of the invention.

[0045] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0046] The following detailed description is provided to gain a comprehensive understanding of the methods, apparatuses and / or systems described herein. Various changes, modifications, and equivalents of the systems, apparatuses and / or methods described herein will suggest themselves to those of ordinary skill in the art.

[0047] Descriptions of well-known functions and structures are omitted to enhance clarity and conciseness. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the present disclosure. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. Furthermore, the use of the terms a, an, etc. does not denote a limitation of quantity, but rather denotes the presence of at least one of the referenced items. The use of the terms “first”, “second”, and the like does not imply any particular order, but they are included to identify individual elements. Moreover, the use of the terms first, second, etc. does not denote any order of importance, but rather the terms first, second, etc. are used to distinguish one element from another. It will be further understood that the terms “comprises” and / or “comprising”, or “includes” and / or “including” when used in this specification, specify the presence of stated features, regions, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, and / or groups thereof.

[0048] Although some features may be described with respect to individual exemplary embodiments, aspects need not be limited thereto such that features from one or more exemplary embodiments may be combinable with other features from one or more exemplary embodiments.

[0049] Provided herein are methods and devices that are configured to provide a short-term solution to major hemorrhagic bleeding to prevent extreme blood loss. For example, methods and devices in accordance with certain aspects of an embodiment can be used prior to admission to an emergency facility, while the patient is in the field, and prior to entering an operating room. Thus, the devices and methods disclosed herein are configured to:

[0050] • Reduce the aortic blood flow rate by up to approximately 90% through applying radial pressure to the aorta to substantially occlude the aorta. This will prevent blood from getting to the wound and, therefore, stop the hemorrhage.

[0051] • Impinge and / or occlude the aorta by inserting the device into the esophagus to compress the aorta from the patient’s esophagus.

[0052] The device according to certain aspects of an embodiment includes an esophageal tube and an actuator. At least a portion of the actuator may be positioned within a sleeve. Further, the device may include an anchor, such as at least one balloon (e.g., a gastric balloon) configured to secure placement of the actuator and / or esophageal tube within the patient.

[0053] Considering the anatomy of the site of interest, and as shown in FIG. 1 (reproduced from The McGraw-Hill Companies, Inc., copyright 2006), the esophagus and the aorta cross above the intersection with the diaphragm. At this site, the aorta is “sandwiched” between the spine and the esophagus. Thus, a device configured as described herein can be inserted into the esophagus through the mouth to this location, and used to apply posterior pressure against the aorta and toward the patient’s spine, which pressure will impinge upon and / or occlude the aorta.

[0054] The pressure applied to the aorta can be directed towards the posterior side of the body, instead of applying pressure in all directions, to advantageously apply the force on the aorta itself and limit unnecessary stretching of the esophagus. Total aortic occlusion is common practice in many medical procedures that involves clamping the aorta. Clamping the aorta to occlude the aorta may require an external pressure of at least 10 times the internal pressure of the aorta. For example, if an internal aortic pressure is 80 mmHg, an external pressure of 800 mmHg would need to be applied. The required force for this pressure is estimated to be about 15 lbs. However, applying pressure slightly greater than 15 lbs. would not be expected to cause any problems. The device according to certain aspects of an embodiment is preferably less than 4.5 cm in diameter so that it may be easily inserted through the mouth. This diameter is estimated based on other devices that can be inserted through the patient’s mouth, however, other diameters that fit into a patient’s mouth are feasible.

[0055] As discussed in detail below, a device according to certain aspects of an embodiment includes at least one actuator to apply a force onto a patient’s aorta. The actuator is configured to control the direction of the force that is applied to the patient’s esophagus, and in turn their aorta. In accordance with certain aspects of an embodiment of the invention, the actuator may comprise mechanisms that apply an occluding force on the aorta, including pneumatic (e.g., symmetric or asymmetric balloons) or hydraulic forces, and mechanical mechanisms (e.g., caused by a pulley or lever arm, a scissor-like mechanism, rigid or semi-rigid catheter-like mechanisms, stent-like mechanisms, and the like), and combinations of the foregoing. The magnitude of force can be controlled to further ensure efficiency of the device. There should generally be enough pressure to occlude the aorta, but the pressure should generally be controlled so that it does not damage internal structures such as the aorta, esophagus, and the spine.

[0056] One embodiment of the device is configured to be more easily inserted and placed at the site of interest than typical devices. For example, and with reference to FIG. 2, a device and method can be used similar to that of the Sengstaken-Blakemore tube. One such embodiment may include a gastric balloon 10 that expands in the stomach to ensure the first balloon 12, or other portions of the device, are in the proper place and not in the stomach. Thus, a device in accordance with certain aspects of an embodiment may include a secondary (stomach or gastric) balloon 10 to ensure that the device is in the desired location and has not gone too far down the patient’s esophagus and into the patient’s stomach. A device in accordance with certain aspects of an embodiment may also include an esophageal tube for gastric content aspiration to remove the gastric contents from the patient’s stomach to reduce the likelihood that the patient will vomit during use of the device.

[0057] In an exemplary configuration and in accordance with certain features of a particularly preferred embodiment of the invention and with reference to FIGs. 3-11, a trans-esophageal aortic flow control device 100 may include an esophageal tube 110, an anchoring device 130, and an actuator 150, wherein the device 100 is configured to at least partially occlude a patient’s aorta. Actuator 150 is configured to apply force posteriorly in the esophagus in a direction of the patient’s aorta, with a force sufficient to at least partially occlude the patient’s aorta. The esophageal tube 110 has a distal end (shown generally at 111) and a proximal end (shown generally at 112). Proximal end 112 of esophageal tube 110 is joined to (and optionally detachable from) a controller 200, which in certain configurations may comprise a hand-held controller. As discussed in greater detail below, controller 200 may provide actuators and / or connectors (all of standard configuration known to and / or readily configurable by those of ordinary skill in the art) enabling the flow of inflating gases or fluids to anchoring device 130 and / or actuator 150, suction to esophageal tube 110, and transmission of mechanical control signals (i.e., movement of mechanical members to modify and control movement, configuration, and deployment of actuator 150 and / or esophageal tube 110).

[0058] With regard to an aspect of the invention, anchoring device 130 is positioned near the distal end 111 of esophageal tube 110, and actuator 150 is positioned proximally to anchoring device 130. Anchoring device 130 may comprise a balloon, such as a gastric balloon that may be formed by way of non-limiting example of silicone, that secures the placement of the distal end 111 of esophageal tube 110 inside of the patient’s stomach with anchoring device 130 inside of the stomach adjacent the gastro-esophageal junction. This will ensure that, when inflated, anchoring device 130 will not retract into the patient’s esophagus from their stomach when the device is in use. Confirmation of proper placement of anchoring device 130 may be obtained through auscultation over the stomach of air injected through a dedicated air channel extending through esophageal tube 110 to distal end 111.

[0059] With respect to a particular aspect of the invention, actuator 150 is positioned proximally to anchoring device 130 by a sufficient distance so that the actuator 150 will be proximal to the intersection of the patient’s esophagus with their diaphragm when the anchoring device 130 is positioned inside of the patient’s stomach as detailed above. In this position, the anchoring device 150 is optimally positioned at a location at which the esophagus and the aorta cross that is above and proximal to the intersection with the patient’s diaphragm, with the patient’s aorta then positioned between the spine and the esophagus. Of course, those skilled in the art will readily recognize that anatomies will differ from patient to patient based at least on their size, such that a trans-esophageal aortic flow control device 100 configured in accordance with aspects of the invention may be provided in differing sizes with differing specific dimensions provided for standard internal physiology of patients of differing sizes and / or ages. Thus, the particular distance between anchoring device 130 and actuator 150 may be selected to provide such positioning with respect to the patient’s aorta and diaphragm based on that standard physiology for a particular patient’s size group or age group.

[0060] In addition to anchoring device 130 near distal end 111 of esophageal tube 110, additional proximal anchoring devices (discussed in greater detail below and shown in FIGs. 4 and 5) that are deployable and retractable from esophageal tube from a position proximal to anchoring device 130 may be provided to laterally stabilize the trans-esophageal aortic flow control device 100 in the patient’s esophagus and / or cover a portion of the aortic diameter. Thus, device 100 may be configured to expand laterally to cover the entire aortic diameter to increase proximal aortic control compared to typical devices. For example, such proximal anchoring devices may be inflated using a fluid to contact the sidewalls of the patient’s esophagus to laterally stabilize device 100 inside of the patient’s esophagus by reducing rotation and / or translation of the device within the esophagus and with respect to the patient’s aorta. In further exemplary configurations, such additional anchoring devices may comprise mechanical assemblies (e.g., extendable portions pushed by rods, wires, screws, cams, or pivots, or similarly configured mechanical operators or drivers) configured to extend contact with the sidewalls of the patient’s esophagus, as further detailed below.

[0061] Next and with particular reference to FIGs. 4 and 5, actuator 150 may take the form of one or more compression balloons 152 that may be inflated to expand from the outer wall of esophageal tube 110 in the direction of the patient’s aorta. As shown in the cross-sectional view of FIG. 6 and the side partial sectional view of FIG. 7, a conduit configured to carry inflation gas or fluid from controller 200 to compression balloon 152 may provide such inflation medium into balloon 152 when trans-esophageal aortic flow control device 100 is in position with anchoring device / gastric balloon 130 inflated inside of the patient’s stomach. Such inflation medium causes compression balloon 152 to extend from the outer wall of esophageal tube 110 to push against the patient’s esophagus and, in turn, compress the patient’s aorta. When not inflated, compression balloon 152 is configured to sit in a collapsed position against the outside of esophageal tube 110. In certain configurations and as shown in FIG. 5, a plurality of such compression balloons 152 may be provided to expand the region of compression that is applied to the patient’s aorta. Further, a top edge 153 of each compression balloon may form a thin, optionally rounded edge that is significantly more narrow than the base of each such balloon 152, and that forms a narrow line that is generally transverse to the longitudinal axis of esophageal tube 110. Such configuration of balloons 152 apply compressive force to the patient’s esophagus, and thus to their aorta, along a concentrated straight line extending transverse to the direction of blood flow in the patient’s aorta, thus further assisting in occlusion of the patient’s aorta. Optionally, one or more additional compression balloons (not shown) may be provided between adjacent compression balloons 153 that may provide a longitudinal compression surface between the two straight line compression balloons, thus further enhancing the occlusion of the patient’s aorta.

[0062] With continued reference to FIGs. 4 and 5 and as mentioned briefly above, in addition to compression balloons 153, proximal anchoring balloons 132 may also be provided which may be inflatable using an inflation fluid conduit similar in configuration to conduit 152 and supplied from controller 200. Proximal anchoring balloons 132 may be inflated after device 100 has been positioned in the patient’s esophagus at the intended position with gastric anchor balloon 130 inside of the patient’s stomach as described above. When inflated, such proximal anchoring balloons 132 may serve to laterally stabilize the trans-esophageal aortic flow control device 100 in the patient’s esophagus and / or cover a portion of the aortic diameter. As shown in FIG. 4, such proximal anchoring balloons 132 may be positioned proximally to compression balloons 152, or as shown in FIG. 5, such proximal anchoring balloons 132 may be positioned alongside compression balloons 153. In each case, proximal anchoring balloons 132 are positioned on esophageal tube 110 so as to, when inflated, apply a force against the patient’s esophagus in a direction that is different from the direction of force application from compression balloons 152, and more preferably are orthogonal to the direction of application of the compression force from compression balloons 152.

[0063] As shown in FIGs. 4 and 5, esophageal tube 110 may include perforations or ports 113 configured to allow fluid flow between the interior of tube 1 10 and the exterior of tube 110. Thus, when suction is applied at proximal end 112 of esophageal tube 110, any fluids inside of the patient’s stomach and / or esophagus may be evacuated through esophageal tube 110.

[0064] Optionally in certain configurations, a compression balloon cover 154 may be provided over a compression balloon 153 as shown in FIGs. 8 and 9, with compression balloon cover 154 configured with a narrow, top edge 155. Compression balloon cover 154 may be formed with creases causing it to take the shape shown in FIG. 8 when fully extended (upon inflation of compression balloon 153), thus forming narrow top edge 155 extending transverse to the longitudinal axis of esophageal tube 110 and, thus, transverse to the direction of blood flow through the patient’s aorta. When compression balloon 153 is uninflated, compression balloon cover 154 takes the form shown in FIG. 9 in which it is collapsed against uninflated compression balloon 153 and the exterior of esophageal tube 110.

[0065] In certain configurations, actuator 150 may further comprise wire fins 160, which in a particularly preferred configuration may be comprised of Nitinol wires that deploy to their intended fin shape when fully deployed from esophageal tube 110. As shown in FIGs. 10(a) - 10(c), a stiff actuation wire 162 may be attached at its distal end to a wire fin 160, and at its opposite proximal end to controller 200. When actuation wire 162 is pushed from actuator 200 towards distal end 111 of esophageal tube 110, the attached wire fin 160 likewise extends outward from esophageal tube 110. FIG. 10(a) shows a wire fin 160 in a retracted position, while FIG. 10(b) shows wire fin 160 in a partially deployed position as it extends outward from esophageal tube 110. As wire fin 160 reaches its fully deployed position shown in FIG. 10(c), the top, outer portion of wire fin 160 assumes its memory shape to form outwardly extending wings 164 on opposite, lateral sides of each wire fin 160. As shown in FIG. 10(c) and the side view of device 100 of FIG. 11 with fully deployed wire fins 160, the extended wings 164 of each wire fin 160 may likewise compress the patient’s esophagus against their aorta again along a line of force application that is transverse to the longitudinal axis of esophageal tube 110, with the extended wings 164 pushing laterally outwardly to expand the region of the patient’s esophagus that engages their aorta. While FIG. 1 1 shows two such wire fins being deployed from esophageal tube 110, those skilled in the art will recognize that any number of wire fins 160 configured as discussed herein may likewise be provided.

[0066] In certain configurations, actuator 150 may comprise in combination wire fins 160 and one or more compression balloons 153 as detailed above, thus forming a dual pneumatic and mechanical mechanism to provide the required directional esophageal compression over the length and width of the underlying aorta. In certain configurations of such dual actuator configurations, wire fins 160 may be positioned outside of compression balloons 153, such as on opposing longitudinal sides of each compression balloon 153, or alternatively one or more wire fins 160 may be positioned inside of a compression balloon 153, all without departing from the spirit and scope of the invention. By way of non-limiting example, a thin, inflatable polyurethane balloon may enclose one or more such wire fins 160. Such a balloon may likewise be formed of higher durometer polyurethanes, silicone, and Pebax. In other configurations, fins 160 may be positioned outside and at opposite ends of balloon 153. The particular dimensions of the balloon and the deployable fins are preferably selected to maximize the diameter and length of aortic compression while minimizing the space that is required within the shaft 170 of esophageal tube 150 to accommodate the deployable fins 160.

[0067] An internal wire mechanism preferably extends through esophageal tube 110 that is configured for stiffening, steering, and stabilizing trans-esophageal aortic flow control device 100 once in the intended position with actuator 150 located to compress the patient’s aorta. Such internal wire mechanism may provide improved steerability so that device 100 can more efficiently be moved into position to occlude the patient’s aorta. As further detailed below, the rigidity of an internal shaft 170 of esophageal tube 110 may be controlled using such wire mechanism to allow greater flexibility for navigating the patient’s oropharynx and esophagus, while also providing sufficient rigidity to enable compression of the patient’s aorta during the deployment of the actuator 150. In an exemplary prototype configuration, the elements of the shaft 170 of esophageal tube 110 were created using Stratasys Vero White 3D printing material with an internal wire that could be actuated to provide stiffening as detailed below. Those skilled in the art will readily recognize that the elements of shaft 170 may likewise be formed through a dedicated design molding process using specific materials that balance their properties with the foregoing requirements for both stiffness and flexibility. In certain preferred configurations, such materials may comprise (by way of non-limiting example) cross-linked polyethylene (PEX), simple polyethylene, and Nylon.

[0068] FIG. 12 shows a manipulable, variable flexibility and steerable shaft 170 in accordance with further aspects of the invention, which may form the primary structure of esophageal tube 110. Shaft 170 (which may optionally be enclosed within a sheath) has a distal end 172 closest to actuator 1 0 and anchor device 130, and a proximal end 174 that may be joined to controller 200. Shaft 170 is preferably formed by a series of segments that may be at least partially articulated with respect to one another so as to aid in steering device 100 to its intended location within the patient’s esophagus. Further and as shown in the cross-sectional view of shaft 170 of FIG. 13, shaft 170 may include a plurality of channels 176 extending through the length of shaft 170 (and thus through each articulating segment of shaft 170) to provide for each of suction through esophageal tube 110, delivery of air to anchor device 130 and actuator 150, tension wires for varying the stiffness of shaft 170, and control wires 162 for deployable fins 160. Tensioning wires (not shown) may extend from controller 200 through shaft 170 and may be retracted or tightened by controller 200 to pull them taught, in turn pulling distal segments of shaft 170 in the direction of controller 200 and causing the assembly to stiffen. When tension is released from such wires, shaft 170 may sit in a more flexible configuration with its articulating segments in turn allowing shaft 170 to conform to the patient’s internal physiology as shaft 170 is moved into position inside of their esophagus.

[0069] With continuing reference to FIG. 12, shaft 170 may, at its proximal portion starting at proximal end 174, form a bendable portion of shaft 170 that may curve when tension is released from the tensioning wires extending through shaft 170. Such bendable portion of shaft 170 may be formed by a series of bending base elements 175 as shown in FIGs. 17(a) and 17(b), each of which has a top concave face 176 and a curved joint wall 177, and a bottom convex face 178 having a curved notch 179. Each top concave face 176 is formed complementary to bottom convex face 178, and each curved joint wall 177 is formed complementary to curved notch 179. With this configuration, adjacent bending base elements 175 may pivot with respect to one another to enable bendable portion of shaft 170 to bend during placement within the patient’s esophagus. Distal to the bending portion is a transition element 180, as shown in FIG. 15(a) and 15(b). Transition element 180 has an upper concave face 181 and curved joint wall 182 for pivotally mating with the adjacent bending base element 175, and has a lower concave face 183 for mating with a complementary face of curved elements 185, as shown in FIG. 16(a) and 16(b), each having complementary and mating top faces 186 and bottom faces 187 enabling them to be joined together in a fixed orientation with respect to one another providing a centrally, fixedly curved portion of shaft 170. Next, the distal most covered element 185 abuts a rigid shaft portion of shaft 170 comprising rigid shaft elements 190 as shown in FIGs. 17(a) and 17(b), each having complimentary and mating top faces 191 and bottom faces 192 enabling them to be joined together in a fixed orientation with respect to one another providing a distal, fixed straight portion of shaft 170. One or more of rigid shaft elements 190 preferably include openings 193 for extension of actuation wires 162, wire fins 160, and any other portions of actuator 150 as may be desirable in a particular implementation.

[0070] In cadaveric testing, a trans-esophageal aortic flow control device 100 configured in accordance with the foregoing disclosure was inserted through the esophagus and into the stomach with placement confirmed by auscultation of air insufflation through a dedicated gastric port in esophageal tube 110. Anchoring device 130 in the form of a distal gastric balloon was inflated, and the device 100 secured at the gastro-esophageal junction. The compression mechanism of actuator 150 was deployed and found capable of achieving near complete transesophageal aortic occlusion at the diaphragmatic hiatus and partial occlusion of the more proximal thoracic aorta.

[0071] Next and with particular reference to FIGs. 18(a) and 18(b), and in accordance with still further aspects of an embodiment of the invention, a trans-esophageal aortic flow control device 1000 may be provided that includes an esophageal tube 1100, an anchoring device 1300 configured as described above and positioned at the distal end of esophageal tube 1100, and an articulating actuator 1500 that may be articulated from a stored position (FIG. 18) to a deployed position (FIG. 19) to provide trans-esophageal compression of the patient’s aorta for aortic flow control. Actuator 1500 includes a pivotable arm 1502 that is pivotably attached to a carrier 1504 that extends through esophageal tube 1100. An inflatable compression balloon 1520 is positioned at the distal end of pivotable arm 1502 and is moveable with pivotable arm 1502. Compression balloon 1520 may be maintained in a deflated state (FIG. 18(a)) as esophageal tube 1100 is placed into the patient’s esophagus and positioned so that anchoring device 1300 is positioned within the patient’s stomach, which as with the configurations discussed above will position actuator 1500 adjacent to the patient’s aorta, and particularly at a location at which, upon deployment of actuator 1500 to the deployed position of FIG. 18(b), will enable a compressive force to be applied posteriorly in the patient’s esophagus in a direction of the patient’s aorta and at a location in the patient’s aorta that is proximal to the patient’s diaphragm.

[0072] A rod, wire, cable, control line, or similarly configured mechanical operator 1506 is affixed to pivotable arm 1502 and preferably extends to a controller configured as discussed above and positioned at and attached to the proximal end of esophageal tube 1100. Upon retraction of mechanical operator 1506 towards the proximal end of esophageal tube 1100, pivotable arm 1502 pivots about pivot mount 1508 of carrier 1504, causing pivotable arm 1502 to pivot out of esophageal tube 1100 through an opening 1510 in esophageal tube 1100 and to a position that is generally or nearly orthogonal to the length of esophageal tube 1100, which will place compression balloon 1520 in a position to engage the interior of the patient’s esophagus adjacent to the patient’s aorta. When deployed to this position and as shown in FIG. 18(b), compression balloon 1520 may be inflated to compress the patient’s esophagus wall against the patient’s aorta.

[0073] Those skilled in the art will recognize that alternative mechanical operators and / or actuators (such as by way of non-limiting example translators, coil shafts, etc.) may be used to pivot pivotable arm 1502 into and out of esophageal tube 1100 without departing from the scope of the invention.

[0074] Preferably, fluid or gas conduits (not shown) likewise extend through esophageal tube 1100 and attach to both anchoring device 1300 and compression balloon 1520 to enable inflation and deflation of anchoring device 1300 and compression balloon 1520 as desired during use.

[0075] Alternatively and as shown in FIGs. 19(a) and 19(b), actuator 1500 may comprise a curving articulable arm 1540 attached to a distal end of carrier, which articulable arm 1 40 may be curved downward and out from esophageal tube 1100 for deployment. A pull wire 1506 or similarly configured mechanical operator as described above again may be affixed to articulable arm 1540 such that retraction of the pull wire 1506 towards the proximal end of esophageal tube 1100 may cause articulable arm 1540 to bend out of esophageal tube 1100 and position compression balloon 1520 in a position that is generally or nearly orthogonal to the length of esophageal tube 1100, which again places compression balloon 1520 in a position to engage the interior of the patient’s esophagus adjacent to the patient’s aorta. When deployed to this position and as shown in FIG. 19(b), compression balloon 1520 may be inflated to compress the patient’s esophagus wall against the patient’s aorta.

[0076] With regard to still further aspects of an embodiment of the invention and with particular reference to FIGs. 20(a) and 20(b), a trans-esophageal aortic flow control device 2000 may be provided that includes an esophageal tube 2100 and an articulating actuator 2500 having an anchoring device 2300 configured as described above and positioned at the distal end of the articulating actuator 2500. Articulating actuator 2500 may be moved from a stored position inside of esophageal tube 2100 to an intermediate position (FIG. 20(a)) in which the articulating actuator 2500 and the anchoring device 2300 are extended outward from the distal end of esophageal tube 2100, and further to a deployed position (FIG. 20(b)) to provide transesophageal compression of the patient’s aorta for aortic flow control.

[0077] Actuator 2500 includes a pivoting assembly comprising multiple segments that are pivotably attached to one another in serial arrangement. More particularly, a first pivoting arm 2502 is pivotably attached at a first end to carrier 2504 that extends through esophageal tube 2100, and is pivotably attached at a second end to a first, proximal end of a compression balloon carrier 2506. Compression balloon carrier 2506 carries compression balloon 2520, and is additionally pivotably attached at its second, distal end to a first, proximal end of a second pivoting arm 2508. Second pivoting arm 2508 is in turn pivotably attached at its second, distal end to a first, proximal end of an anchoring device carrier 2510, and anchoring device 2300 is affixed to the distal end of anchoring device carrier 2510.

[0078] Inflatable compression balloon 2520 is positioned at the side of compression balloon carrier 2506 and is moveable with compression balloon carrier 2506. Compression balloon 2520 may be maintained in a deflated state as esophageal tube 2100 is placed into the patient’s esophagus and positioned so that anchoring device 2300 is positioned within the patient’s stomach, which as with the configurations discussed above will position actuator 2500 adjacent to the patient’s aorta, and particularly at a location at which, upon deployment of actuator 2500 to the deployed position of FIG. 20(b)2, will enable a compressive force to be applied posteriorly in the patient’s esophagus in a direction of the patient’s aorta and at a location in the patient’s aorta that is proximal to the patient’s diaphragm.

[0079] A rod, wire, cable, control line, or similarly configured mechanical operator 2512 is affixed to anchoring device carrier 2510 and preferably extends to a controller configured as discussed above and positioned at and attached to the proximal end of esophageal tube 2100. Upon retraction of mechanical operator 2510 towards the proximal end of esophageal tube 2100, first pivoting arm 2502 and second pivoting arm 2508 each pivot at their respective ends, in turn causing compression balloon carrier 2506 to move outward from the longitudinal axis of esophageal tube 2100 to place compression balloon 2520 in a position to engage the interior of the patient’s esophagus adjacent to the patient’s aorta. When deployed to this position and as shown in FIG. 20(b), compression balloon 2520 may be inflated to compress the patient’s esophagus wall against the patient’s aorta.

[0080] While the foregoing exemplary embodiments of a trans-esophageal aortic flow control device envisage direct contact between a compression balloon and the patient’s esophagus, those exemplary embodiments may likewise be used in combination with one or more mechanical devices configured for trans-esophageal aortic flow control. By way of non-limiting example, U.S. Patent No. 11,523,832 to Rabin et al. titled “Trans-Esophageal Aortic Flow Rate Control” describes a device having a mechanically-operated head assembly with manipulable arms or clamp blades that may be operated to apply compressive pressure against the interior wall of the patient’s esophagus at a location so as to compress the patient’s aorta. The foregoing embodiments of a trans-esophageal aortic flow control device as set forth herein may be combined with such a mechanically-operated head assembly with manipulable arms (e.g., by positioning a trans-esophageal aortic flow control device in accordance with the exemplary embodiments described herein adjacent to a mechanically-operated head assembly as described in U.S. Patent No. 11,523,832) both to aid in anchoring the mechanically-operated head at a desired location in the patient’s esophagus and to isolate the direction of force application to the patient’s esophagus via anchoring devices and compression balloons as described with respect to the exemplary embodiments herein.

[0081] As will be clear to those of ordinary skill in the art from the foregoing disclosure, abdominal hemorrhage control presents a major unmet clinical need. By controlling the aortic flow in the descending part of the aorta proximal to the patient’s diaphragm, devices and methods configured in accordance with aspects of the invention will substantially prevent blood flow to the lower chest and abdomen. This will significantly reduce blood loss and extend the life of the patient long enough to allow for a surgeon to access and repair the wound area. Devices and methods configured in accordance with aspects of the invention are less invasive and easier to implement for aortic occlusion than typical methods, such as REBOA, and thus offer significant improvement over previously known devices and methods.

[0082] Having now fully set forth the preferred embodiments and certain modifications of the concept underlying the present invention, various other embodiments as well as certain variations and modifications of the embodiments herein shown and described will obviously occur to those skilled in the art upon becoming familiar with said underlying concept. Thus, it should be understood, therefore, that the invention may be practiced otherwise than as specifically set forth herein.

Claims

CLAIMSWhat is claimed is:

1. A trans-esophageal aortic flow control device, comprising: an esophageal tube having a distal end and a proximal end; an anchoring device adjacent the distal end of the esophageal tube and configured to secure placement of the distal end of the esophageal tube in a patient’s stomach; an articulating actuator comprising: a carrier extending through the esophageal tube; at least one movable arm connected to the carrier; a compression balloon mounted on the movable arm; and a mechanical operator configured to move the movable arm between: a stored position in which the movable arm and compression balloon are positioned within the esophageal tube, and a deployed position in which the movable arm extends outward from the esophageal tube to position the compression balloon to apply a compressive force posteriorly in the patient’s esophagus in a direction of the patient’s aorta; wherein the articulating actuator is positioned proximally to the anchoring device by a sufficient distance to cause the compression balloon to be aligned with a portion of the patient’s esophagus that is distal to an intersection of the patient’s esophagus and the patient’s diaphragm when the anchoring device is positioned inside of the patient’s stomach.

2. The device of claim 1, wherein the at least one movable arm comprises a pivotable arm pivotably attached to the carrier, and wherein the mechanical operator is configured to pivot the pivotable armfrom the stored position to the deployed position through an opening in the esophageal tube.

3. The device of claim 2, wherein retraction of the mechanical operator towards the proximal end of the esophageal tube causes the pivotable arm to pivot about a pivot mount of the carrier.

4. The device of claim 2, wherein in the deployed position, the compression balloon is positioned generally orthogonal to a length of the esophageal tube.

5. The device of claim 1, wherein the at least one movable arm comprises a curving articulable arm attached to a distal end of the carrier, and wherein the mechanical operator comprises a pull wire configured to curve the articulable arm from the stored position to the deployed position.

6. The device of claim 5, wherein retraction of the pull wire towards the proximal end of the esophageal tube causes the curving articulable arm to bend out of the esophageal tube to position the compression balloon generally orthogonal to a length of the esophageal tube.

7. The device of claim 1, wherein the at least one movable arm comprises: a first pivoting arm having a first end pivotably attached to the carrier and a second end; a compression balloon carrier having a first end pivotably attached to the second end of the first pivoting arm and a second end, wherein the compression balloon is positioned on the compression balloon carrier; a second pivoting arm having a first end pivotably attached to the second end of the compression balloon carrier and a second end; and an anchoring device carrier having a first end pivotably attached to the second end of thesecond pivoting arm, wherein the anchoring device is affixed to a distal end of the anchoring device carrier.

8. The device of claim 7, wherein retraction of the mechanical operator towards the proximal end of the esophageal tube causes the first pivoting arm and second pivoting arm to pivot at their respective ends to move the compression balloon carrier outward from a longitudinal axis of the esophageal tube.

9. The device of claim 1, further comprising fluid or gas conduits extending through the esophageal tube and attached to both the anchoring device and the compression balloon.

10. The device of claim 1, wherein the compression balloon is maintained in a deflated state as the esophageal tube is placed into the patient’s esophagus.

11. A method for controlling aortic blood flow using a trans-esophageal aortic flow control device, comprising: providing a trans-esophageal aortic flow control device comprising: an esophageal tube having a distal end and a proximal end; an anchoring device adjacent the distal end of the esophageal tube; an articulating actuator comprising: a carrier extending through the esophageal tube; at least one movable arm connected to the carrier; a compression balloon mounted on the movable arm; and a mechanical operator;inserting the esophageal tube through a patient’s esophagus with the compression balloon in a deflated state; positioning the anchoring device inside the patient’s stomach; inflating the anchoring device to secure placement of the distal end of the esophageal tube; operating the mechanical operator to move the movable arm from a stored position within the esophageal tube to a deployed position extending outward from the esophageal tube; and inflating the compression balloon to apply a compressive force posteriorly in the patient’s esophagus in a direction of the patient’s aorta.

12. The method of claim 11, wherein the at least one movable arm comprises a pivotable arm pivotably attached to the carrier, and wherein operating the mechanical operator comprises retracting the mechanical operator towards the proximal end of the esophageal tube to pivot the pivotable arm about a pivot mount of the carrier through an opening in the esophageal tube.

13. The method of claim 11, wherein the at least one movable arm comprises a curving articulable arm attached to a distal end of the carrier, and wherein operating the mechanical operator comprises retracting a pull wire towards the proximal end of the esophageal tube to curve the articulable arm out of the esophageal tube.

14. The method of claim 11, wherein the at least one movable arm comprises: a first pivoting arm having a first end pivotably attached to the carrier and a second end; a compression balloon carrier having a first end pivotably attached to the second end of the first pivoting arm and a second end, wherein the compression balloon is positioned on the compression balloon carrier;a second pivoting arm having a first end pivotably attached to the second end of the compression balloon carrier and a second end; and an anchoring device carrier having a first end pivotably attached to the second end of the second pivoting arm, wherein the anchoring device is affixed to a distal end of the anchoring device carrier.

15. The method of claim 14, wherein operating the mechanical operator comprises retracting the mechanical operator towards the proximal end of the esophageal tube to cause the first pivoting arm and second pivoting arm to pivot at their respective ends to move the compression balloon carrier outward from a longitudinal axis of the esophageal tube.

16. The method of claim 11, further comprising confirming proper placement of the anchoring device through auscultation over the stomach of air injected through an air channel extending through the esophageal tube to the distal end.

17. The method of claim 11, wherein the compression balloon is positioned proximally to the anchoring device by a sufficient distance to cause the compression balloon to be aligned with a portion of the patient’s esophagus that is distal to an intersection of the patient’s esophagus and the patient’s diaphragm when the anchoring device is positioned inside of the patient’s stomach.

18. The method of claim 11, further comprising applying suction through the esophageal tube to evacuate fluids from the patient’s stomach and esophagus.

19. The method of claim 11, wherein inflating the compression balloon comprises inflating thecompression balloon to a pressure sufficient to achieve near complete trans-esophageal aortic occlusion at the diaphragmatic hiatus.

20. The method of claim 11, wherein the compression balloon is inflated to compress the patient’s esophagus wall against the patient’s aorta to substantially prevent blood flow to the lower chest and abdomen.

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