WO2021019221A1 - Device, method and system for compressing the descending abdominal aorta - Google Patents

Device, method and system for compressing the descending abdominal aorta Download PDF

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Publication number
WO2021019221A1
WO2021019221A1 PCT/GB2020/051788 GB2020051788W WO2021019221A1 WO 2021019221 A1 WO2021019221 A1 WO 2021019221A1 GB 2020051788 W GB2020051788 W GB 2020051788W WO 2021019221 A1 WO2021019221 A1 WO 2021019221A1
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WO
WIPO (PCT)
Prior art keywords
patient
pressure
cylinder
compression
compression device
Prior art date
Application number
PCT/GB2020/051788
Other languages
French (fr)
Inventor
Grethe HEITMANN
Original Assignee
Exac As
Samuels, Adrian James
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Exac As, Samuels, Adrian James filed Critical Exac As
Publication of WO2021019221A1 publication Critical patent/WO2021019221A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/132Tourniquets
    • A61B17/1322Tourniquets comprising a flexible encircling member
    • A61B17/1325Tourniquets comprising a flexible encircling member with means for applying local pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00221Electrical control of surgical instruments with wireless transmission of data, e.g. by infrared radiation or radiowaves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00367Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A61B2017/00398Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like using powered actuators, e.g. stepper motors, solenoids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0046Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
    • A61B2017/00473Distal part, e.g. tip or head
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00544Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated pneumatically
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00858Material properties high friction, non-slip
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06Measuring instruments not otherwise provided for
    • A61B2090/064Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A61B2090/065Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension for measuring contact or contact pressure

Definitions

  • the present invention relates to a device, method and system for external compressing of the descending abdominal aorta.
  • the device is intended for non- intrusive treatment, such as for women suffering from Post Partum haemorrhage (PPH).
  • PPH Post Partum haemorrhage
  • the device may also be used for other situations where aorta compression is required.
  • Post Partum haemorrhage is defined as a cumulative blood loss of more than 1000ml or bleeding associated with signs or symptoms of hypovolemia within 24 hours of the delivery. Late or secondary PPH may occur in the first 6 weeks after delivery. The incidence of PPH worldwide is about 5 percent and is a major contributor to maternal mortality.
  • PPH Specifically in the third world and rural areas without easy access to advanced medical treatment facilities, PPH represent a serious risk to the health of the women giving birth. Every year about 14 million women around the world suffer from PPH. The risk of maternal mortality from haemorrhage is 1 in 1 000 deliveries in developing countries.
  • the main causes of PPH are a retained placenta, trauma in the birth canal and an atonic uterus.
  • the conventional treatments for PPH include surgery and/or complex medication.
  • the Applicant has appreciated however that deaths caused by PPH can be easily preventable, with methods such as manual aortic compression improving outcomes for patients.
  • Manual aortic compression is a technique that can be applied to reduce bleeding from the uterus and birth canal by reducing the blood supply. External manual compression of the aorta against the spinal column with a fist just above the umbilicus may achieve near total arrest in femoral blood flow, thus preventing cardiac arrest from hypovolemia and allowing further treatment to be provided.
  • this technique requires an additional healthcare worker to provide the manual compression and a second person may not always be available to provide this compression.
  • PPH compression belt devices such as the Abdominal Aortic Junctional
  • TourniquetTM induce complete cessation of blood flow to the pelvis and lower extremities by overall abdominal compression.
  • the Applicant has appreciated there are shortcomings associated with this method of abdominal compression, in particular that devices such as the AAJTTM also compress central veins in the abdomen. The post-partum uterus is enlarged and the upper boundary may be found above the umbilicus. The AAJTTM does not take this into consideration. As the AAJTTM generates the same pressure around the patient, the direct
  • the belt is therefore required to be tight to provide high pressure which leads to discomfort for the patient.
  • the present invention provides a compression device for compression of the descending abdominal aorta of a patient comprising: a rigid mounting member,
  • a support structure comprising a base portion and at least two side arms connected to or arranged to be connected to the rigid mounting member wherein the pressure member is mounted so as to be extendable relative to the rigid mounting member along an extension axis, the rigid mounting member extends laterally away from the extension axis in at least two directions and wherein the device is arranged such that when connected around the abdomen of a patient in use, the extendable pressure member is able to apply a continuous pressure to the abdomen of the patient, without the support structure applying a lateral pressure to said patient.
  • the device provides a means of stopping or decreasing blood loss caused by post-partum haemorrhage.
  • the device provides continuous external compression of the abdominal aorta and therefore provides temporary lifesaving treatment until further treatment can be provided.
  • the descending abdominal aorta lies between the spinal column and the extendable pressure member when the device is in use and is therefore compressed by the device.
  • embodiments of the present invention are able to provide the required pressure on the descending abdominal aorta without unnecessary and undesirable lateral compression of the patient’s abdomen. Compression can be provided to the descending abdominal aorta only, such that the central veins of the abdomen are not compressed. This is achieved by the laterally extending rigid mounting member and base portion which together allow the side arms to be held away from the sides of the patient when the pressure member is applying pressure to the abdomen, with the base portion, situated in use under the patient’s back, providing the necessary counter-force.
  • rigid as used herein should be understood as meaning that the mounting member is rigid enough to allow the side arms to be held away from the patient’s sides to avoid applying pressure thereto during normal use. A small degree of flexing consistent with this is not excluded.
  • the innovation contributes to simplification and durability of tools available for a patient group, and also in communities that cannot offer advanced health care to women, being victim of PPH.
  • the invention makes this contribution through embodiments which may provide a specialized device that, in its simplest form, can be reused numerous times, and can be applied in seconds to women after the delivery of the child in the case when midwife suspects that the woman suffers from PPH.
  • the device when applied, will provide compression of the descending abdominal aorta and efficiently stop or at least decrease the blood stream loss through the haemorrhage.
  • the main purpose of the device is to provide a device that can provide temporary life-saving treatment until definitive treatment can be provided.
  • the device can be provided in a purely mechanical form, close to maintenance free, but also in more complex form being driven by electric/pneumatic power source.
  • the device may comprise a cylinder and an expandable and retractable piston rod, the piston rod comprising a pressure element and the device further comprising driving means for extending and retracting the piston rod.
  • driving means may comprise executing a manually hand operated force on a push knob operating on a plunger like bolt or a turning knob operating a nut and bolt manual screw action that ensure expansion of the piston rod causing external compression of the descending abdominal aorta cranially of the uterus.
  • the extendable pressure member further comprises a pressure element.
  • the pressure element will be in contact with the patient’s abdomen when the compression device is in use and will therefore apply pressure to the abdomen.
  • connection between the support structure and rigid mounting member is releasable. This may enable the device to be quickly applied to an abdomen to prevent bleeding as the support structure may be slid under the back of the patient, and the rigid mounting member placed on the abdomen, with the pressure element compressing the correct portion of the abdomen to reduce blood flow through the descending abdominal aorta before connection to the support structure.
  • the compression location on the abdomen may therefore be easily adjusted as the rigid mounting member may be moved separately to the support structure before connection, as opposed to an abdomen tourniquet belt, where the whole belt may need to be adjusted.
  • the device may be easier to apply to a patient who is experiencing PPH compared to a tourniquet belt.
  • the above-mentioned releasable connection is adjustable.
  • the device may thus be easily used on different size patients.
  • the side straps define a plurality of holes which enable them to be adjustably connected to hooks on the rigid mounting member to locate it over the top of the patient’s abdomen when in use.
  • the particular form of attachment is not essential and other forms of releasable connections may be used instead of the hooks and holes.
  • the side arms may each be connected to respective sides of the base portion. Therefore, when the compression device is in use, the patient may lie on top of the base portion and the side arms may extend around, but held away from, the sides of the patient.
  • the side arms are at least semi-rigid. This may help them to be held away from the patient’s sides in use. Semi-rigid side arms may also be easier than a soft belt to slide under the patient.
  • the base portion is preferably rigid and may comprise a base plate.
  • the base plate or the base portion defines an aperture to allow access to the patient’s spine when the compression device is fitted around a patient’s abdomen, e.g. to allow a spinal injection to be administered. In this way, compression may still be provided to the abdomen, stopping or reducing PPH whilst a spinal injection is carried out e.g. prior to surgery for treatment of the PPH.
  • the pressure member could be extended from the rigid mounting member in any of a number of different ways.
  • a screw-threaded mechanism is provided. This may be advantageous in providing fine manual control of the pressure provided.
  • a pneumatic or hydraulic mechanism is provided.
  • the extension of the pressure member is preferably easy to adjust - e.g. by a simple user control.
  • This is advantageous as external aortic compression may need to be dynamic when patients receive treatment such as medication (uterotonics), surgery (suture of tears, removal of retained placenta) or volume therapy to restore circulation.
  • the extendable pressure member could be mounted directly to the mounting member (e.g. by engaging with a threaded portion thereof) but in a set of embodiments, the extendable pressure member is provided in a housing mounted on or integral with the rigid mounting member which may contain the extension mechanism. The pressure member may therefore not be separable from the rigid mounting member.
  • the device comprises an emergency pressure release arrangement.
  • This provides a safety mechanism that is independent of a normal pressure adjustment to quickly remove or reduce the compression on the aorta in the event that this becomes necessary.
  • the pressure member or housing is rapidly separable from the rigid mounting member e.g. with a single action. This may provide a safety feature whereby if the extendable pressure member is compressing the abdomen too much, it may be quickly removed to restore blood flow along the descending abdominal aorta and into the lower portion of the body. This separation may be provided be means of a quick-release mechanism or similar, which allows the extendable pressure member (optionally with its housing) to be removed from the mounting member without removing the connected mounting member and support structure from the patient’s abdomen.
  • the pressure element is deformable.
  • the deformable pressure element may contact the abdomen of the patient.
  • the deformable pressure element may deform to mould to the patient. This may provide better compression of the descending abdominal aorta within the abdomen of the patient as the deformable pressure element can mould around the descending abdominal aorta and spinal column within the abdomen. Further to this, the deformable pressure element may be provide more comfort for the patient.
  • the invention When viewed from a second aspect the invention provides a compression device for external compression of the descending abdominal aorta of a patient, comprising:
  • a mounting member defining a recess
  • a pressure member comprising a pressure element at a distal end thereof mounted so as to be able to extend from or retract into the recess along an extension axis;
  • a holding element connected to the mounting member so as in use to hold the mounting member steady in an umbilical region of the patient so as to allow the pressure element to apply pressure to an abdomen of the patient.
  • the mounting member is rigid and extends laterally away from the extension axis, the holding element being connected to the mounting member at a distal region thereof such that in use said pressure element is able to apply said pressure without applying a lateral pressure to said patient.
  • the invention When viewed from a third aspect the invention provides a compression device for external compression of the descending abdominal aorta of a patient, comprising: a housing defining a cylindrical recess; and
  • a piston comprising a proximal end slidably received in the cylindrical recess and a pressure element at a distal end thereof, and
  • the holding element comprises a stand.
  • the stand comprises a first portion arranged to be held in use by a weight of the patient and a second portion connected to the housing.
  • the holding element comprises a hard-form belt.
  • the invention When viewed from a fourth aspect the invention provides a compression device for external compression of the descending abdominal aorta, comprising:
  • a piston comprising a proximal end slidably received in the cylindrical recess and a pressure element at a distal end thereof
  • housing comprises connecting means for connecting the device to fastening means for holding the device in use.
  • the invention When viewed from a fifth aspect the invention provides a compression device for external compression of the descending abdominal aorta, comprising:
  • a cylinder defined by a base and a recess with an opening
  • the piston rod comprise a proximal end slideably arranged via the opening in the recess of the cylinder, and the piston rod further comprise a distal end connected to a pressure element,
  • the cylinder having connecting means for connecting the device to fastening means for holding the device steady when used.
  • the invention When viewed from a sixth aspect the invention provides a method for external compression of the descending abdominal aorta, wherein the method
  • the method further comprises the step of applying manual aorta compressions and identifying the exact position of the descending abdominal aorta in the patient prior to arranging the compression device in the umbilical region.
  • Figure 1 is an isometric view of the compression device in accordance with the present invention.
  • Figure 2 is a side view of the compression device of Figure 1 ;
  • Figure 3 is a cross-sectional view of the compression device of Figure 1 when extended;
  • Figure 4 is a plan view of the rigid member
  • Figure 5a shows the pressure element of the compression device in use prior to compression
  • Figure 5b shows the pressure element of the compression device in use whilst compressing the abdominal aorta
  • FIG. 6 shows another version of a compression device in accordance with the invention
  • FIG. 7 shows a complete tourniquet version of another compression device in accordance with the invention.
  • FIG. 8A shows a cross section view of the device in fig. 7 in retracted mode
  • FIG. 8B shows a cross section view of the device in fig. 7 in an expanded mode
  • FIG. 9 shows a cross section oblique view of the device in fig. 7 in an expanded mode
  • FIG. 10 shows an exploded view of the device in fig. 6
  • FIG. 11 shows a cross section view of the exploded view of the device in fig. 13;
  • FIG. 12 shows a tourniquet belt for use with the compression device of fig. 6;
  • FIG. 13 shows a bellow in retracted mode
  • FIG. 14 shows a bellow in expanded mode
  • FIG. 15 shows a cross section of the bellow in retracted mode of fig. 13
  • Fig. 16 shows the compression device attached to a body in the tourniquet like embodiment of fig. 2
  • Fig. 17 shows a cross section of the compression device attached to a body in the tourniquet like embodiment of fig. 7, also showing spine and aorta uncompressed in the umbilical region of the abdomen;
  • Fig. 18 shows a cross section of the compression device attached to a body in the tourniquet like embodiment of fig. 7, also showing spine and aorta compressed towards the front of the spine in the umbilical region of the abdomen;
  • Fig. 19A show a side view cross section of a compression device in accordance with the invention applied to a woman;
  • Fig. 19B show a side view cross section of a compression device in accordance with the invention provided with a stand connected to a fixed connection point;
  • Fig. 19C show a side view cross section of a compression device in accordance with the invention provided with a stand
  • Fig. 20A show a cross section view of a further embodiment of the compression device, showing a pressurized Gas/Fluid driven compression device;
  • Fig. 20B show a cross section view of a further embodiment of the compression device, showing a simplified push down mechanism
  • Fig. 20C show a cross section view of a further embodiment of the compression device, showing a simplified piston - cylinder interaction
  • Fig. 21 illustrates an embodiment of the invention used with remote computing resources and cloud computing network.
  • Figure 1 is an isometric view of a compression device 2 in accordance with the present invention.
  • Figure 2 is a side view of the same compression device 2.
  • Figure 3 shows a cross-sectional view of the compression device 2 when extended in use.
  • the compression device 2 comprises a pressure mechanism 4 which comprises an extendable pressure member (element 26 of Fig. 3) and is mounted on a rigid mounting member 6, in turn connected to a support structure 8.
  • the support structure 8 comprises a base portion 10 in the form of a rigid base plate and two semi-rigid side arms 12. The side arms 12 are each attached to respective ends of the base portion 10.
  • the base portion 10 of the support structure 8 has an aperture 20.
  • the rigid mounting member 6 has a central opening 14 which receives the pressure mechanism 4, as shown in Figure 4.
  • the pressure mechanism 4 is separable from the rigid mounting member 6, for example by means of a quick-release mechanism as will be described in more detail below.
  • the extendable pressure member 26 is extendable along an extension axis 22.
  • the rigid mounting member 6 extends laterally away from the extension axis 22 in two opposite directions such that when the device 2 is connected around the abdomen of a patient in use, the rigid mounting member 6 will extend towards the sides of the patient.
  • the pressure mechanism 4 comprises a housing 24 which defines a cylindrical recess which slidingly receives an extendable pressure member 26 having a pressure element 28 at the distal end thereof the extendable pressure member 26.
  • the pressure element 28 is designed to contact the abdomen of a patient when the device 2 is in use.
  • the pressure mechanism 4 further comprises a rotatable knob 30 which is arranged outside the housing 24.
  • the rotatable knob 30 extends beyond the upper surface of the rigid mounting member 6 when the pressure mechanism 4 is mounted on the rigid mounting member 6.
  • the rotatable knob 30 is fixedly connected to a spindle 32 by means of a connector 33. Therefore, when the rotatable knob 30 is rotated, the spindle 32 will also rotate.
  • the spindle 32 has an external thread which engages with a corresponding thread on the interior of the extendable pressure member 26. Therefore, when the rotatable knob 30 and spindle 32 are rotated, the extendable pressure member 26 is made to extend beyond the housing 24 of the pressure mechanism 4. Therefore, extension of the pressure member 26 may be easily controlled by means of the rotatable knob 30.
  • the pressure mechanism 4 may be separated from the rigid mounting member 6 by means of a quick-release mechanism. However this is not essential - the housing could be provided integrally with the mounting member.
  • the housing 24 of the pressure mechanism 4 is oval and has a series of grooves 25 at the ends of its long axis.
  • Corresponding flanges 27 extend from the rigid mounting member 6 and engage with the grooves 25 of the housing 24. As may be seen with reference to Fig. 4, the aperture 14 in the mounting member 6 is enlarged at locations 35 which are 90° round from the flanges 27so that through rotation of the pressure mechanism 4 by 90°, the flanges 27 will disengage from the grooves 25 and the oval shape of pressure mechanism 4 is able to pass through the aperture 14 so that it may be quickly removed.
  • the grooves 25 further provide a crude pressure adjustment means.
  • the user of the compression device 2 may choose to engage grooves 25 further up the housing 24 to engage with the flanges 27 which will alter the initial position of the pressure element 28 relative to the abdomen of the patient.
  • the side arms 12 of the support structure 8 are semi-rigid and have a series of holes 16 to enable connection to the rigid mounting member 6 by means of hooks 18, which are provided at the two distal ends of the rigid mounting member 6.
  • the hooks 18 may easily be engaged in the appropriate holes 16 to adjust the fit of the device to the size of the patient.
  • the aperture 20 therefore provides medical professionals with access to the patient’s back e.g. to allow an epidural to be administered. In this way, compression may still be provided to the abdomen, stopping or reducing PPH whilst an epidural is carried out e.g. to provide pain relief for abdominal surgery following PPH.
  • the support structure 8 is placed underneath a patient suffering from PPH.
  • one of the semi-rigid side arms 12 may be pushed underneath the patient’s back and pulled through so that the patient lies on top of the base portion 10 with the side arms 12 extending beyond either side of their abdomen.
  • the weight of the patient will hold the base portion 10 steady.
  • the rigid mounting member 6 is then positioned on top of the abdomen of the patient and connected to the support structure 8 via the hooks 18 on the rigid mounting member 6 and holes 16 in the side arms 12.
  • the hooks 18 are inserted into the appropriate holes 16 depending on the size of the patient’s abdomen.
  • the pressure mechanism 4 may then be attached by inserting it into the aperture 14 on the mounting member and twisting it 24 through 90° to engage the flanges 27 of the mounting member with an appropriate pair of grooves 25 in the housing 24 of the pressure mechanism.
  • FIGS. 5a and 5b show further detail of the operation of the extendable pressure member 26.
  • Figure 5a shows the extendable pressure element 26 partially extended along the extension axis 22 before contact is made with the patient’s abdomen 34.
  • This Figure also shows schematically in cross-section the
  • the extendable pressure element 26 is further and compresses the descending abdominal aorta 36 against the spinal column 38.
  • the device 2 will therefore stop or reduce post-partum haemorrhage until further treatment options are available to the patient, therefore providing a temporary life-saving treatment.
  • the rigid mounting member 6 and the rigid base portion 10 ensure that the semi-rigid side arms 12 are held away from the sides of the patients and thus do not cause undesirable lateral
  • the pressure element 28 which actually contacts the abdomen 34 of the patient is deformable. Therefore, when pressure is applied to the abdomen 34 through the extension of the extendable pressure element 26, the pressure element 28 deforms to mould to the patient, as shown in Figure 5b. This provides more effective compression of the descending abdominal aorta 36.
  • the quick release mechanism described above may be employed to allow blood flow to be very quickly restored to the lower portion of the body, as through a simple twist, the pressure mechanism 4 can be very quickly removed.
  • Other safety mechanisms for reducing or removing pressure could be provided - e.g. when the pressure mechanism is integral with the mounting member.
  • Embodiments of the invention provide a device that it is so small and efficient that it can compress the aorta cranially of the uterus.
  • Embodiments of the present invention may provide the ability for health personnel to gradually adjust the pressure as blood transfusion or crystalloid treatment normalize blood volume, and further provide the possibility to adjust the pressure during the treatment so that drugs for contraction of the uterus can be administered intravenously.
  • a further advantage which may be provided by the invention is that it will save spending of blood products and thus give women a lower risk of transfusion reactions.
  • FIG 6 and figure 7, shows a first embodiment of the compression device 1001.
  • the embodiment first described here is a manually operated compression device having a pressure element 1004 that is formed specifically to be able to apply a pressure directly above the descending abdominal aorta when positioned in the umbilical region of a woman after birth of a baby.
  • the pressure element 1004 When the device 1001 is arranged in the umbilical region of the woman/patient and a piston rod 1003, to which the pressure element 1004 is attached in the distal end, is extended in the posterior direction relative the patient, the pressure element 1004 will ensure an increased pressure on the descending abdominal aorta and stop or at least decrease blood supply into the uterine. Any haemorrhage in this region will then be reduced.
  • the operation of the device 1001 is provided by the device 1001 comprising a cylinder 1002 having a base 1013 and a recess 1014 with an opening 1019, and the expandable and retractable piston rod 1003.
  • the piston rod 1003 comprise a proximal end slideably arranged via the opening 1019 in the recess 1014 of the cylinder 1002, and the distal end of the piston rod 1003 is connected to the pressure element 1004.
  • the cylinder 1002 is provided with external connecting means 1005 for connecting the device 1001 to fastening means for holding the device 1001 steady when used and such that when the device 1001 is arranged on a patient 100 in the umbilical region the cylinder base 1013 facing in an anterior direction and the pressure element 1004 facing in a posterior direction, the piston protrudes inwardly pressurizing the abdomen of the patient even when the piston 1003 is in a retracted position.
  • the device 1001 further comprising driving means for extending and retracting 1043 the piston rod 1003.
  • the connecting means 1005 is provided with connecting elements 1071.
  • the connecting elements 1071 in the first embodiment, connects to a holding element in the form of a belt 1070.
  • the belt may be a flexible belt, a hard form belt or a mix of the two.
  • the belt could be hard formed in several parts to be assembled in a construction like a frame similar to the LUCAS Chest Compression System which is well known by the skilled person and not discussed in detail here.
  • the connection to the connecting elements 1071 may be a fast clickable connection, and the belt 1070 may comprise means for adjusting the length of the belt 1070.
  • the belt may be threadbare through the connecting elements 1071 , and easily tightened for the adjustment to a patient by a lock feature in the connecting elements, for example a rope clam feature known from climbing techniques, or a Velcro® strap.
  • a lock feature in the connecting elements for example a rope clam feature known from climbing techniques, or a Velcro® strap.
  • One possible embodiment of the belt 1070 is illustrated in figure 12.
  • Other locking and adjustment features may be implemented as well-known for a skilled person.
  • the driving means for extending and retracting 1043 the piston rod 1003 is in a first embodiment comprised of a turning knob 1006 arranged outside the base side 1013 of the cylinder 1002 such that it easily accessible when arranged on a patient.
  • the turning knob 1006 is connected to a proximal end of a spindle 1008 as shown in figure 8A and 8B.
  • the connection may be provided by a connecting member 1007 as illustrated.
  • the spindle 1008 may be provided with outward facing threads 1011 which corresponds an internally threaded recess 1012 in the piston rod 1003.
  • the distal end of the spindle 1008 engaged into the recess 1012 of the piston rod 1003 in a manner that when the turning knob 1006 is rotated 1041 the spindle rotates 1042 and the piston rod 1003 extend and retract 1043 dependent on which way the turning knob 1006 is rotated as illustrated in figure 9.
  • the extending and retracting 1043 of the piston rod 1003 is provided by the feature of the piston rod 1003 further comprise longitudinal guiding protrusions or recesses 1009 which slidingly interact with corresponding internal longitudinal recesses or protrusions 1010 on the inside wall of the cylinder 1002 such that the piston rod
  • the pressure element 1004 can easily be pushed or pulled towards/away from the patient.
  • the fixed connection of the turning knob 1006 to the spindle 1008 is provided by a first conduit 1015 through the base 1013 of the cylinder 1002 and a second conduit 1016 through the center of the turning knob 1006.
  • the proximal end of the spindle is formed first closest to the threads 1011 of the spindle 1008 in a circular section 1050 having a corresponding diameter to a circular conduit 1015 through the base of the cylinder 1002.
  • the proximal end may be formed in a cube form 1051 for inserting into a corresponding cube formed recess 1031 on the underside of the turning knob 1006.
  • the second conduit 1016 through the center of the turning knob 1006 may be formed such that a thinner portion 1016 wider than the bolt diameter, but thinner than the bolt head 1052 leads from the top side of the turning knob 1006 to the cube recess 1031 on the underside.
  • the thinner portion 1016 of the conduit may on the top side of the turning knob 1006 comprise a recess 1044 for partly or completely receive the bolt head 1052.
  • the proximal end of the spindle 1008 may further comprise a centered internally threaded recess 1018 for reception of the distal end of the bolt 1007 that may have corresponding externally arranged threads 1060.
  • Bellow holding means 1017 may be formed as a protruding disc externally formed on the outside of the cylinder 1002, being arranged between the connecting means 1005 and the end of the cylinder 1002 with the opening 1019 in the recess 1014.
  • the bolt 1007 is lead through the first and 1016 and the second 1015 conduits from the top side connecting the turning knob 1006 on top of the cylinder 1002 base 1013, and when bolt is fixed to the proximal end of the spindle 1008, for example by screwing it into the centered internally threaded recess 1018, the spindle 1008 is pulled up through the first conduit, and the second conduit such that it is fixedly connected to the turning knob, and freely rotates in the first conduit.
  • the cube form of the recess 1031 on the underside of the turning knob 1006 receives and holds the corresponding cube form 1051 of the proximal end of the spindle 1008, and thus ensures the fixed connection between the turning knob 1006 and the spindle 1008.
  • connection and assembly features of the turning knob , the spindle, the piston rod and the cylinder may be arranged differently, for example by gluing, soldering or other mechanical connecting techniques.
  • the driving means for extending and retracting 1043 the piston rod 1003 is comprised of a plunger knob 1156 arranged outside the base side 1013 of the cylinder 1002 such that it easily accessible when arranged on a patient.
  • the plunger knob 1156 is connected to a proximal end of the piston rod via a piston extender 1155.
  • the outside of the piston rod have proximal end facing saw tooth form 1154 corresponding to distal end facing saw tooth 1154' form formed on the inside of the cylinder 1002. Such that when pushing with a downward force on the plunger knob, the saw tooth forms
  • the interacting saw tooth forms may be arranged in longitudinal sections radially spaced with a distance at least as long as the saw tooth forms (not shown), such that the piston rod 1003 can be twisted a fraction of a circle to let the saw tooth occupy a section of the cylinder 1002 not having saw tooth form and vice versa. This way it is possible to slide back the piston rod 1003 into the cylinder 1002 if needed to ease off the pressure executed by the device.
  • the driving means for extending and retracting 1043 the piston rod 1003 is comprised of a turning knob 1006 arranged outside the base side 1013 of the cylinder 1002 such that it easily accessible when arranged on a patient.
  • the turning knob 1006 is connected to a proximal end of the piston rod via a piston extender 1155.
  • the outside of the piston rod have piston rod threads 1158 corresponding to cylinder threads 1159 formed on the inside of the cylinder 1002.
  • the piston rod 1003 is in its distal end connected to the pressure element 1004 in a non-rotating coupling 1200 meaning that when the piston rod 1003 is rotating the pressure element is resting in a fixed manner on the skin of the patient.
  • Figures 13, 14 and 15 illustrate one embodiment of a bellow 1080, 1081 constructed to be mounted on the compression device 1001 for protecting the movable portion of the piston rod 1003 and the pressure element 1004.
  • the bellow 1080, 1081 may be designed to cover both the side and the bottom portion of the compression device 1001 , comprising also the underside of the pressure element 1004.
  • the bellow could be made of a durable and flexible material which is easily cleaned after each use.
  • it could be provided a bellow 1080, 1081 intended for one time use, such that cleaning process could be more efficient, and use procedure includes to mount a new bellow 1080, 1081 for each time the compression device is used.
  • the bottom portion 1081 of the bellow 1080, 1081 may be of a material providing one or more of: non-slip surface, cushion effect, isolation to prevent "cold surface", replaceable antiseptic pad or other.
  • Figure 13 shows the bellow 1080 side wall in a compressed state, whilst figure 14 shows the same in an extended state, the piston rod inside being correspondingly in a retracted and extended position.
  • the pressure element 1004 may be provided in various sizes and dimensions, and a preferred form would be one that had a longitudinal length less than the transverse width, and more preferred form having a size of 3-7 cm in the patient longitudinal direction, and 5-9 cm in the patient transverse direction, and even more preferred form having a size of 5 cm in the patient longitudinal direction, and 7 cm in the patient transverse direction
  • Figure 16 illustrates the device 1001 arranged in the umbilical region of the woman/patient 1100.
  • the cross section figures in figure 17 and figure 18 shows how the abdominal descending aorta 1120 is affected when the compression device is arranged in the umbilical region with the belt encircling the patient.
  • the aorta 1120 is more or less unaffected, even if the compression device "bury itself to a certain degree in the "loose" umbilical area of the abdomen to the patient.
  • Figure 19A illustrates a method how the compression device 1001 may be operating to cut off blood stream through the abdominal descending aorta 1120 if a midwife/nursing personnel suspect that the patient suffer from PPH.
  • the compression device 1001 must be arranged in the umbilical area of the patient, and tightly fixed.
  • the pressure element 1004 is extended by for example turning the turning knob 1006 of a first embodiment of the compression device 1001. The effect is that, if correctly arranged to increase the pressure on the descending aorta 1120, the blood flow through the aorta may be
  • the operator of the compression device 1001 typically will check the success by increasing the pressure by further operate the compression device, extending the piston stem 1003 further and confirming that the pulsations of femoral artery. This is easily observed by using the free hand 1140 to feel for pulsations of femoral artery.
  • the holding element may be provided in other forms than the form of a belt 1070 as discussed above.
  • the holding element may be provided as a stand 1141 , 1142 or part of other treatment apparatus.
  • a stand 1142 may be fixed to a stretcher or bed as illustrated in figure 19B where the fixed connection 1143 may be the side bars of a bed, or even the inside wall of an ambulance or the like.
  • the stand may even be formed to use the patient weight holding a first portion 144 of the stand, and a second portion 1141 of the stand being connected to the compression device holding it in place above the patient as coarsely described in figure 19C.
  • Even further embodiments of the compression device may comprise linear actuators replacing the manual driven turning knob and spindle for extending and retracting the piston stem and pressure element. Such further embodiments may be electrical or pneumatically powered.
  • a pneumatically driven piston rod is illustrated in a non-detailed illustration in figure 20.
  • Such compression device as shown in figure 20 having driving means provided by a pressure chamber 1151 in the cylinder 1002 wherein the pressure chamber 1151 having a gas or fluid supply conduit 1152 for receiving or expelling pressurized 1150 gas or fluid, such that when gas or fluid is entering or exiting the pressure chamber 1151 , the piston rod 1153 expands or retracts 1043 respectively.
  • Sensor(s) 1045, 1046 may be arranged in the pressure element 1004 and/or in the bottom portion 1081 of the bellow or separate (not shown) to the compression device as a strap on sensor for use for example sensing the femoral artery, and sensor input may be used to control the operation of the linear actuator used to expand/retract the piston rod.
  • the sensors may be battery operated and communicate directly with computer or handheld such as a smart phone being provided with application able to receive and handle sensor data.
  • Sensors 1045, 1046 in the device may also constantly sense the pressure waves through the artery and adjusts the counter pressure depending on pulse pressure. Thus, it may be possible to detect if the device is displaced under operation, and corrective actions may be quickly performed if necessary.
  • a powered compression device In a system embodiment of a powered compression device it can be provided a communication module and remote processing resources such as computers 1160 and/or handheld custom computing devices 1160 for remote surveillance/operation. Once installed to the patient the control may be managed remotely. Remote facilities may also comprise data resources and storage for storing and analyzing sensor data, and such resources may also be provided in a connected cloud 1161 computing system.
  • the invention can also be understood to comprise the following additional embodiments:
  • a first additional embodiment of a compression device 1001 for external compression of the descending abdominal aorta comprising: a cylinder 1002 defined by a base 1013 and a recess 1014 with an opening 1019, a piston rod 1003, wherein the piston rod 1003 comprise a proximal end slideably arranged via the opening 1019 in the recess 1014 of the cylinder 1002, and the piston rod 1003 further comprise a distal end connected to a pressure element 1004, the cylinder 1002 having connecting means 1005 for connecting the device 1001 to fastening means for holding the device 1001 steady when used.
  • the driving means comprise a plunger knob 1156, a piston extender 1155, wherein the plunger knob 1156 is arranged outside the base side 1013 of the cylinder 1002 and is connected to a proximal end of the piston rod 1003 via the piston extender 1155, and the outside of the piston rod 1003 having proximal end facing saw tooth form 1154 corresponding to distal end facing saw tooth 1154' form formed on the inside of the cylinder 1002, such that when pushing with a downward force on the plunger knob 1156 the saw tooth forms 1154, 1154' of the piston rod 1003 and the cylinder 1002 interacts and ensures that the piston rod 1003 is not gliding back into the cylinder 1002.
  • an eighth additional embodiment of the compression device 1001 according to any one of the first to seventh embodiment, wherein the fastening means comprising: a holding element being connected to the connecting means 1005, and the connecting means 1005 being connected to or part of the outside mid portion of the cylinder 1002, such that when the device 1001 is arranged on a patient 1100 in the umbilical region the cylinder base 1013 facing in an anterior direction and the pressure element 1004 facing in a posterior direction, the piston protrudes inwardly pressurizing the abdomen of the patient even when the piston 1003 is in a retracted position.
  • the fastening means comprising: a holding element being connected to the connecting means 1005, and the connecting means 1005 being connected to or part of the outside mid portion of the cylinder 1002, such that when the device 1001 is arranged on a patient 1100 in the umbilical region the cylinder base 1013 facing in an anterior direction and the pressure element 1004 facing in a posterior direction, the piston protrudes inwardly pressurizing the abdomen of the patient even when the piston 1003
  • the holding element is a belt 1070 for encircling a patient 1100 in the abdomen region
  • the belt 1070 is connected in both ends to connecting elements 1071 of the connecting means 1005, such that when fastened to the patient, the device 1001 can be held in place externally on the abdomen in the umbilical region.
  • a first additional method embodiment for external compression of the descending abdominal aorta comprising of the following steps:
  • a first additional system embodiment for external compression of the descending abdominal aorta comprising:
  • compression device according to any one of the first to thirteenth additional embodiments of the compression device 1001 ,
  • a second additional system embodiment according to the first additional system embodiment, further comprising: cloud based computing
  • the device may be used for other situations requiring manual aorta compression such as life-threatening penetrating trauma below the umbilicus, life-threatening blunt trauma and/or crus injuries below the diaphragm, life-threatening lower extremity haemorrhage that has failed tourniquet placement, and life-threatening junctional haemorrhage that has failed wound packing and haemostatic agents.

Abstract

A compression device (2) is used for compression of the descending abdominal aorta (36) of a patient. The device (2) comprises a rigid mounting member (6), an extendable pressure member (26), and a support structure (8) which comprises a base portion (10) and at least two side arms (12) connected to or arranged to be connected to the rigid mounting member (6). The pressure member (26) is mounted so as to be extendable relative to the rigid mounting member (6) along an extension axis (22), and the rigid mounting member (6) extends laterally away from the extension axis (22) in at least two directions. The device (2) is arranged such that when connected around the abdomen (34) of a patient in use, the extendable pressure member (26) is able to apply a continuous pressure to the abdomen (34) of the patient and therefore stop or decrease blood loss caused by post-partum haemorrhage, without the support structure (8) applying a lateral pressure to said patient.

Description

Device, method and system for compressing the descending abdominal aorta
TECHNICAL FIELD
The present invention relates to a device, method and system for external compressing of the descending abdominal aorta. The device is intended for non- intrusive treatment, such as for women suffering from Post Partum haemorrhage (PPH). The device may also be used for other situations where aorta compression is required.
BACKGROUND
Post Partum haemorrhage (PPH) is defined as a cumulative blood loss of more than 1000ml or bleeding associated with signs or symptoms of hypovolemia within 24 hours of the delivery. Late or secondary PPH may occur in the first 6 weeks after delivery. The incidence of PPH worldwide is about 5 percent and is a major contributor to maternal mortality.
The risks associated with PPH are twofold. First, if the loss of blood is not arrested, death will be the final result. Second, the resultant anaemia weakens the patient, lowers resistance, and predisposes the patient to puerperal infection. Additionally, even when available, blood transfusions give rise to risks of transfusion reactions, and spending of a limited resource.
Specifically in the third world and rural areas without easy access to advanced medical treatment facilities, PPH represent a serious risk to the health of the women giving birth. Every year about 14 million women around the world suffer from PPH. The risk of maternal mortality from haemorrhage is 1 in 1 000 deliveries in developing countries.
The main causes of PPH are a retained placenta, trauma in the birth canal and an atonic uterus. The conventional treatments for PPH include surgery and/or complex medication. The Applicant has appreciated however that deaths caused by PPH can be easily preventable, with methods such as manual aortic compression improving outcomes for patients. Manual aortic compression is a technique that can be applied to reduce bleeding from the uterus and birth canal by reducing the blood supply. External manual compression of the aorta against the spinal column with a fist just above the umbilicus may achieve near total arrest in femoral blood flow, thus preventing cardiac arrest from hypovolemia and allowing further treatment to be provided. However, this technique requires an additional healthcare worker to provide the manual compression and a second person may not always be available to provide this compression. During transportation of a patient, it is very difficult to maintain external aortic compression without increased risk for the healthcare workers.
PPH compression belt devices, such as the Abdominal Aortic Junctional
Tourniquet™ (AAJT™) induce complete cessation of blood flow to the pelvis and lower extremities by overall abdominal compression. The Applicant has appreciated there are shortcomings associated with this method of abdominal compression, in particular that devices such as the AAJT™ also compress central veins in the abdomen. The post-partum uterus is enlarged and the upper boundary may be found above the umbilicus. The AAJT™ does not take this into consideration. As the AAJT™ generates the same pressure around the patient, the direct
compression of the aorta against the spinal column is inhibited. The belt is therefore required to be tight to provide high pressure which leads to discomfort for the patient.
SUMMARY OF THE DISCLOSURE
When viewed from a first aspect, the present invention provides a compression device for compression of the descending abdominal aorta of a patient comprising: a rigid mounting member,
an extendable pressure member, and
a support structure comprising a base portion and at least two side arms connected to or arranged to be connected to the rigid mounting member wherein the pressure member is mounted so as to be extendable relative to the rigid mounting member along an extension axis, the rigid mounting member extends laterally away from the extension axis in at least two directions and wherein the device is arranged such that when connected around the abdomen of a patient in use, the extendable pressure member is able to apply a continuous pressure to the abdomen of the patient, without the support structure applying a lateral pressure to said patient.
Thus it will be appreciated by those skilled in the art, that in accordance with the present invention, the device provides a means of stopping or decreasing blood loss caused by post-partum haemorrhage. In particular, the device provides continuous external compression of the abdominal aorta and therefore provides temporary lifesaving treatment until further treatment can be provided. The descending abdominal aorta lies between the spinal column and the extendable pressure member when the device is in use and is therefore compressed by the device.
In contrast with providing abdominal pressure with a device secured by means of a belt, embodiments of the present invention are able to provide the required pressure on the descending abdominal aorta without unnecessary and undesirable lateral compression of the patient’s abdomen. Compression can be provided to the descending abdominal aorta only, such that the central veins of the abdomen are not compressed. This is achieved by the laterally extending rigid mounting member and base portion which together allow the side arms to be held away from the sides of the patient when the pressure member is applying pressure to the abdomen, with the base portion, situated in use under the patient’s back, providing the necessary counter-force.
The term“rigid’ as used herein should be understood as meaning that the mounting member is rigid enough to allow the side arms to be held away from the patient’s sides to avoid applying pressure thereto during normal use. A small degree of flexing consistent with this is not excluded.
The innovation contributes to simplification and durability of tools available for a patient group, and also in communities that cannot offer advanced health care to women, being victim of PPH. The invention makes this contribution through embodiments which may provide a specialized device that, in its simplest form, can be reused numerous times, and can be applied in seconds to women after the delivery of the child in the case when midwife suspects that the woman suffers from PPH. The device, when applied, will provide compression of the descending abdominal aorta and efficiently stop or at least decrease the blood stream loss through the haemorrhage.
The main purpose of the device is to provide a device that can provide temporary life-saving treatment until definitive treatment can be provided.
The device can be provided in a purely mechanical form, close to maintenance free, but also in more complex form being driven by electric/pneumatic power source.
The device may comprise a cylinder and an expandable and retractable piston rod, the piston rod comprising a pressure element and the device further comprising driving means for extending and retracting the piston rod. The simplest form of driving means may comprise executing a manually hand operated force on a push knob operating on a plunger like bolt or a turning knob operating a nut and bolt manual screw action that ensure expansion of the piston rod causing external compression of the descending abdominal aorta cranially of the uterus.
Further advanced versions of the device may be provided for use in combination with for example stretchers, operating tables, delivery chairs or other medical equipment.
In a set of embodiments, the extendable pressure member further comprises a pressure element. The pressure element will be in contact with the patient’s abdomen when the compression device is in use and will therefore apply pressure to the abdomen.
In a set of embodiments, the connection between the support structure and rigid mounting member is releasable. This may enable the device to be quickly applied to an abdomen to prevent bleeding as the support structure may be slid under the back of the patient, and the rigid mounting member placed on the abdomen, with the pressure element compressing the correct portion of the abdomen to reduce blood flow through the descending abdominal aorta before connection to the support structure. The compression location on the abdomen may therefore be easily adjusted as the rigid mounting member may be moved separately to the support structure before connection, as opposed to an abdomen tourniquet belt, where the whole belt may need to be adjusted.
Additionally, as the rigid mounting member and support structure are separable, the device may be easier to apply to a patient who is experiencing PPH compared to a tourniquet belt.
In a set of embodiments the above-mentioned releasable connection is adjustable. The device may thus be easily used on different size patients. In an exemplary set of embodiments the side straps define a plurality of holes which enable them to be adjustably connected to hooks on the rigid mounting member to locate it over the top of the patient’s abdomen when in use. However the particular form of attachment is not essential and other forms of releasable connections may be used instead of the hooks and holes.
The side arms may each be connected to respective sides of the base portion. Therefore, when the compression device is in use, the patient may lie on top of the base portion and the side arms may extend around, but held away from, the sides of the patient.
In a set of embodiments, the side arms are at least semi-rigid. This may help them to be held away from the patient’s sides in use. Semi-rigid side arms may also be easier than a soft belt to slide under the patient. The base portion is preferably rigid and may comprise a base plate.
In a set of embodiments, the base plate or the base portion defines an aperture to allow access to the patient’s spine when the compression device is fitted around a patient’s abdomen, e.g. to allow a spinal injection to be administered. In this way, compression may still be provided to the abdomen, stopping or reducing PPH whilst a spinal injection is carried out e.g. prior to surgery for treatment of the PPH. The pressure member could be extended from the rigid mounting member in any of a number of different ways. In a set of embodiments a screw-threaded mechanism is provided. This may be advantageous in providing fine manual control of the pressure provided. In other embodiments a pneumatic or hydraulic mechanism is provided. Regardless of the actual mechanism for extending the pressure member, the extension of the pressure member is preferably easy to adjust - e.g. by a simple user control. This is advantageous as external aortic compression may need to be dynamic when patients receive treatment such as medication (uterotonics), surgery (suture of tears, removal of retained placenta) or volume therapy to restore circulation.
The extendable pressure member could be mounted directly to the mounting member (e.g. by engaging with a threaded portion thereof) but in a set of embodiments, the extendable pressure member is provided in a housing mounted on or integral with the rigid mounting member which may contain the extension mechanism. The pressure member may therefore not be separable from the rigid mounting member.
In a set of embodiments, the device comprises an emergency pressure release arrangement. This provides a safety mechanism that is independent of a normal pressure adjustment to quickly remove or reduce the compression on the aorta in the event that this becomes necessary. In a set of embodiments the pressure member or housing is rapidly separable from the rigid mounting member e.g. with a single action. This may provide a safety feature whereby if the extendable pressure member is compressing the abdomen too much, it may be quickly removed to restore blood flow along the descending abdominal aorta and into the lower portion of the body. This separation may be provided be means of a quick-release mechanism or similar, which allows the extendable pressure member (optionally with its housing) to be removed from the mounting member without removing the connected mounting member and support structure from the patient’s abdomen.
Therefore the pressure to the patient’s abdomen can be quickly and easily reduced, in addition to the fine pressure control which is possible via the extension of the extendable pressure member. ln a set of embodiments, the pressure element is deformable. When the
compression device is in use, the deformable pressure element may contact the abdomen of the patient. When pressure is applied to the abdomen through the extension of the extendable pressure element, the deformable pressure element may deform to mould to the patient. This may provide better compression of the descending abdominal aorta within the abdomen of the patient as the deformable pressure element can mould around the descending abdominal aorta and spinal column within the abdomen. Further to this, the deformable pressure element may be provide more comfort for the patient.
When viewed from a second aspect the invention provides a compression device for external compression of the descending abdominal aorta of a patient, comprising:
a mounting member defining a recess;
a pressure member comprising a pressure element at a distal end thereof mounted so as to be able to extend from or retract into the recess along an extension axis; and
a holding element connected to the mounting member so as in use to hold the mounting member steady in an umbilical region of the patient so as to allow the pressure element to apply pressure to an abdomen of the patient.
In a set of embodiments the mounting member is rigid and extends laterally away from the extension axis, the holding element being connected to the mounting member at a distal region thereof such that in use said pressure element is able to apply said pressure without applying a lateral pressure to said patient.
When viewed from a third aspect the invention provides a compression device for external compression of the descending abdominal aorta of a patient, comprising: a housing defining a cylindrical recess; and
a piston comprising a proximal end slidably received in the cylindrical recess and a pressure element at a distal end thereof, and
a holding element connected to the housing and arranged in use to hold the housing steady in an umbilical region of the patient so as to allow the pressure element to apply pressure to an abdomen of the patient. ln a set of embodiments the holding element comprises a stand. In a set of such embodiments the stand comprises a first portion arranged to be held in use by a weight of the patient and a second portion connected to the housing.
In a set of embodiments the holding element comprises a hard-form belt.
When viewed from a fourth aspect the invention provides a compression device for external compression of the descending abdominal aorta, comprising:
a housing defining a cylindrical recess; and
a piston comprising a proximal end slidably received in the cylindrical recess and a pressure element at a distal end thereof,
wherein the housing comprises connecting means for connecting the device to fastening means for holding the device in use.
When viewed from a fifth aspect the invention provides a compression device for external compression of the descending abdominal aorta, comprising:
a cylinder defined by a base and a recess with an opening,
a piston rod, wherein
the piston rod comprise a proximal end slideably arranged via the opening in the recess of the cylinder, and the piston rod further comprise a distal end connected to a pressure element,
the cylinder having connecting means for connecting the device to fastening means for holding the device steady when used.
When viewed from a sixth aspect the invention provides a method for external compression of the descending abdominal aorta, wherein the method
comprise of the following steps:
- detecting blood loss of patient indicating patient suffering post partum
haemorrhage,
- arranging compression device as described herein in the
umbilical region of the patient, and
- activating the driving means of the compression device to compress the descending
abdominal aorta. ln a preferred embodiment, the method further comprises the step of applying manual aorta compressions and identifying the exact position of the descending abdominal aorta in the patient prior to arranging the compression device in the umbilical region.
Features of any aspect or embodiment described herein may, wherever appropriate, be applied to any other aspect or embodiment described herein.
Where reference is made to different embodiments, it should be understood that these are not necessarily distinct but may overlap.
BRIEF DESCRIPTION OF THE DRAWINGS
One or more non-limiting examples will now be described, by way of example only, and with reference to the accompanying figures in which:
Figure 1 is an isometric view of the compression device in accordance with the present invention;
Figure 2 is a side view of the compression device of Figure 1 ;
Figure 3 is a cross-sectional view of the compression device of Figure 1 when extended;
Figure 4 is a plan view of the rigid member;
Figure 5a shows the pressure element of the compression device in use prior to compression;
Figure 5b shows the pressure element of the compression device in use whilst compressing the abdominal aorta;
FIG. 6 shows another version of a compression device in accordance with the invention;
FIG. 7 shows a complete tourniquet version of another compression device in accordance with the invention;
FIG. 8A shows a cross section view of the device in fig. 7 in retracted mode;
FIG. 8B shows a cross section view of the device in fig. 7 in an expanded mode; FIG. 9 shows a cross section oblique view of the device in fig. 7 in an expanded mode;
FIG. 10 shows an exploded view of the device in fig. 6;
FIG. 11 shows a cross section view of the exploded view of the device in fig. 13; FIG. 12 shows a tourniquet belt for use with the compression device of fig. 6;
FIG. 13 shows a bellow in retracted mode;
FIG. 14 shows a bellow in expanded mode;
FIG. 15 shows a cross section of the bellow in retracted mode of fig. 13;
Fig. 16 shows the compression device attached to a body in the tourniquet like embodiment of fig. 2
Fig. 17 shows a cross section of the compression device attached to a body in the tourniquet like embodiment of fig. 7, also showing spine and aorta uncompressed in the umbilical region of the abdomen;
Fig. 18 shows a cross section of the compression device attached to a body in the tourniquet like embodiment of fig. 7, also showing spine and aorta compressed towards the front of the spine in the umbilical region of the abdomen;
Fig. 19A show a side view cross section of a compression device in accordance with the invention applied to a woman;
Fig. 19B show a side view cross section of a compression device in accordance with the invention provided with a stand connected to a fixed connection point;
Fig. 19C show a side view cross section of a compression device in accordance with the invention provided with a stand;
Fig. 20A show a cross section view of a further embodiment of the compression device, showing a pressurized Gas/Fluid driven compression device;
Fig. 20B show a cross section view of a further embodiment of the compression device, showing a simplified push down mechanism;
Fig. 20C show a cross section view of a further embodiment of the compression device, showing a simplified piston - cylinder interaction;
Fig. 21 illustrates an embodiment of the invention used with remote computing resources and cloud computing network.
Figure 1 is an isometric view of a compression device 2 in accordance with the present invention. Figure 2 is a side view of the same compression device 2. Figure 3 shows a cross-sectional view of the compression device 2 when extended in use. The compression device 2 comprises a pressure mechanism 4 which comprises an extendable pressure member (element 26 of Fig. 3) and is mounted on a rigid mounting member 6, in turn connected to a support structure 8. The support structure 8 comprises a base portion 10 in the form of a rigid base plate and two semi-rigid side arms 12. The side arms 12 are each attached to respective ends of the base portion 10. The base portion 10 of the support structure 8 has an aperture 20.
The rigid mounting member 6 has a central opening 14 which receives the pressure mechanism 4, as shown in Figure 4. The pressure mechanism 4 is separable from the rigid mounting member 6, for example by means of a quick-release mechanism as will be described in more detail below.
As seen in Fig. 3, the extendable pressure member 26 is extendable along an extension axis 22. The rigid mounting member 6 extends laterally away from the extension axis 22 in two opposite directions such that when the device 2 is connected around the abdomen of a patient in use, the rigid mounting member 6 will extend towards the sides of the patient.
The pressure mechanism 4 comprises a housing 24 which defines a cylindrical recess which slidingly receives an extendable pressure member 26 having a pressure element 28 at the distal end thereof the extendable pressure member 26. The pressure element 28 is designed to contact the abdomen of a patient when the device 2 is in use. The pressure mechanism 4 further comprises a rotatable knob 30 which is arranged outside the housing 24. The rotatable knob 30 extends beyond the upper surface of the rigid mounting member 6 when the pressure mechanism 4 is mounted on the rigid mounting member 6. The rotatable knob 30 is fixedly connected to a spindle 32 by means of a connector 33. Therefore, when the rotatable knob 30 is rotated, the spindle 32 will also rotate.
The spindle 32 has an external thread which engages with a corresponding thread on the interior of the extendable pressure member 26. Therefore, when the rotatable knob 30 and spindle 32 are rotated, the extendable pressure member 26 is made to extend beyond the housing 24 of the pressure mechanism 4. Therefore, extension of the pressure member 26 may be easily controlled by means of the rotatable knob 30. As mentioned above, the pressure mechanism 4 may be separated from the rigid mounting member 6 by means of a quick-release mechanism. However this is not essential - the housing could be provided integrally with the mounting member. As will be noted from Fig. 1 , the housing 24 of the pressure mechanism 4 is oval and has a series of grooves 25 at the ends of its long axis. Corresponding flanges 27 extend from the rigid mounting member 6 and engage with the grooves 25 of the housing 24. As may be seen with reference to Fig. 4, the aperture 14 in the mounting member 6 is enlarged at locations 35 which are 90° round from the flanges 27so that through rotation of the pressure mechanism 4 by 90°, the flanges 27 will disengage from the grooves 25 and the oval shape of pressure mechanism 4 is able to pass through the aperture 14 so that it may be quickly removed.
The grooves 25 further provide a crude pressure adjustment means. Depending on the size of the abdomen to be compressed, the user of the compression device 2 may choose to engage grooves 25 further up the housing 24 to engage with the flanges 27 which will alter the initial position of the pressure element 28 relative to the abdomen of the patient.
The side arms 12 of the support structure 8 are semi-rigid and have a series of holes 16 to enable connection to the rigid mounting member 6 by means of hooks 18, which are provided at the two distal ends of the rigid mounting member 6. The hooks 18 may easily be engaged in the appropriate holes 16 to adjust the fit of the device to the size of the patient.
As the support structure 8 will be fastened around the patient’s abdomen in use, the base portion 10 will lie against the patient’s back. The aperture 20 therefore provides medical professionals with access to the patient’s back e.g. to allow an epidural to be administered. In this way, compression may still be provided to the abdomen, stopping or reducing PPH whilst an epidural is carried out e.g. to provide pain relief for abdominal surgery following PPH.
Use of the device 2 will now be described. First the support structure 8 is placed underneath a patient suffering from PPH. For example one of the semi-rigid side arms 12 may be pushed underneath the patient’s back and pulled through so that the patient lies on top of the base portion 10 with the side arms 12 extending beyond either side of their abdomen. The weight of the patient will hold the base portion 10 steady. The rigid mounting member 6 is then positioned on top of the abdomen of the patient and connected to the support structure 8 via the hooks 18 on the rigid mounting member 6 and holes 16 in the side arms 12. As there are multiple holes 16 in the side arms 12, the hooks 18 are inserted into the appropriate holes 16 depending on the size of the patient’s abdomen. If not already attached, the pressure mechanism 4 may then be attached by inserting it into the aperture 14 on the mounting member and twisting it 24 through 90° to engage the flanges 27 of the mounting member with an appropriate pair of grooves 25 in the housing 24 of the pressure mechanism.
Next the knob 30 is rotated to cause the pressure member 26 to extend from the housing 24 Figures 5a and 5b show further detail of the operation of the extendable pressure member 26. Figure 5a shows the extendable pressure element 26 partially extended along the extension axis 22 before contact is made with the patient’s abdomen 34. This Figure also shows schematically in cross-section the
descending aorta 36 and spinal column 38. As the knob 30 is twisted further as shown in Figure 5b, the extendable pressure element 26 is further and compresses the descending abdominal aorta 36 against the spinal column 38. The device 2 will therefore stop or reduce post-partum haemorrhage until further treatment options are available to the patient, therefore providing a temporary life-saving treatment.
As pressure is applied by the pressure member 26, the rigid mounting member 6 and the rigid base portion 10 ensure that the semi-rigid side arms 12 are held away from the sides of the patients and thus do not cause undesirable lateral
compression as would occur with a belt or strap.
It will further be noted that the pressure element 28 which actually contacts the abdomen 34 of the patient is deformable. Therefore, when pressure is applied to the abdomen 34 through the extension of the extendable pressure element 26, the pressure element 28 deforms to mould to the patient, as shown in Figure 5b. This provides more effective compression of the descending abdominal aorta 36.
Although the device may be necessary during instances of post-partum
haemorrhage, if there is too little blood flow to the lower portion of the body, this may cause further complications. Therefore, the quick release mechanism described above may be employed to allow blood flow to be very quickly restored to the lower portion of the body, as through a simple twist, the pressure mechanism 4 can be very quickly removed. Other safety mechanisms for reducing or removing pressure could be provided - e.g. when the pressure mechanism is integral with the mounting member.
Further embodiments of the compression device are described below, with reference to Figures 6-21. In the following description of various embodiments, reference will be made to the drawings, in which like reference numerals denote the same or corresponding elements. The drawings are not necessarily to scale.
Instead, certain features may be shown exaggerated in scale or in a somewhat simplified or schematic manner, wherein certain conventional elements may have been left out in the interest of exemplifying the principles of the invention rather than cluttering the drawings with details that do not contribute to the understanding of these principles.
It should be noted that, unless otherwise stated, different features or elements may be combined with each other whether or not they have been described together as part of the same embodiment below. The combination of features or elements in the exemplary embodiments are done in order to facilitate understanding of the invention rather than limit its scope to a limited set of embodiments, and to the extent that alternative elements with substantially the same functionality are shown in respective embodiments, they are intended to be interchangeable. For the sake of brevity, no attempt has been made to disclose a complete description of all possible permutations of features.
Furthermore, those with skill in the art will understand that the invention may be practiced without many of the details included in this detailed description.
Conversely, some well-known structures or functions may not be shown or described in detail, in order to avoid unnecessarily obscuring the relevant description of the various implementations. The terminology used in the description presented below is intended to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific implementations of the invention. With the exception of structural details that are specifically developed for a particular type of equipment, for example using a belt as holding element, or a purely manually operated mechanical driving means the devices described herein are adaptable for use with a wide range of equipment including not only belts, but also stands and fixed installations, and also other driving means such as electrical or pneumatically driven driving means.
For ease of understanding, some of the examples described herein will primarily describe embodiments where devices are mounted on the exterior of an abdomen in the umbilical area with a body encircling belt, but as previously shown other embodiments which comprise a more rigid support structure are also provided. The examples may also be generalized to other types of equipment.
Embodiments of the invention provide a device that it is so small and efficient that it can compress the aorta cranially of the uterus. Embodiments of the present invention may provide the ability for health personnel to gradually adjust the pressure as blood transfusion or crystalloid treatment normalize blood volume, and further provide the possibility to adjust the pressure during the treatment so that drugs for contraction of the uterus can be administered intravenously.
A further advantage which may be provided by the invention is that it will save spending of blood products and thus give women a lower risk of transfusion reactions.
Reference is first made to figure 6 and figure 7, which shows a first embodiment of the compression device 1001. The embodiment first described here is a manually operated compression device having a pressure element 1004 that is formed specifically to be able to apply a pressure directly above the descending abdominal aorta when positioned in the umbilical region of a woman after birth of a baby. When the device 1001 is arranged in the umbilical region of the woman/patient and a piston rod 1003, to which the pressure element 1004 is attached in the distal end, is extended in the posterior direction relative the patient, the pressure element 1004 will ensure an increased pressure on the descending abdominal aorta and stop or at least decrease blood supply into the uterine. Any haemorrhage in this region will then be reduced. The operation of the device 1001 is provided by the device 1001 comprising a cylinder 1002 having a base 1013 and a recess 1014 with an opening 1019, and the expandable and retractable piston rod 1003. The piston rod 1003 comprise a proximal end slideably arranged via the opening 1019 in the recess 1014 of the cylinder 1002, and the distal end of the piston rod 1003 is connected to the pressure element 1004. The cylinder 1002 is provided with external connecting means 1005 for connecting the device 1001 to fastening means for holding the device 1001 steady when used and such that when the device 1001 is arranged on a patient 100 in the umbilical region the cylinder base 1013 facing in an anterior direction and the pressure element 1004 facing in a posterior direction, the piston protrudes inwardly pressurizing the abdomen of the patient even when the piston 1003 is in a retracted position. The device 1001 further comprising driving means for extending and retracting 1043 the piston rod 1003.
The connecting means 1005 is provided with connecting elements 1071. The connecting elements 1071 , in the first embodiment, connects to a holding element in the form of a belt 1070. The belt may be a flexible belt, a hard form belt or a mix of the two. The belt could be hard formed in several parts to be assembled in a construction like a frame similar to the LUCAS Chest Compression System which is well known by the skilled person and not discussed in detail here. The connection to the connecting elements 1071 may be a fast clickable connection, and the belt 1070 may comprise means for adjusting the length of the belt 1070. In one embodiment the belt may be threadbare through the connecting elements 1071 , and easily tightened for the adjustment to a patient by a lock feature in the connecting elements, for example a rope clam feature known from climbing techniques, or a Velcro® strap. One possible embodiment of the belt 1070 is illustrated in figure 12. Other locking and adjustment features may be implemented as well-known for a skilled person.
The driving means for extending and retracting 1043 the piston rod 1003 is in a first embodiment comprised of a turning knob 1006 arranged outside the base side 1013 of the cylinder 1002 such that it easily accessible when arranged on a patient. The turning knob 1006 is connected to a proximal end of a spindle 1008 as shown in figure 8A and 8B. The connection may be provided by a connecting member 1007 as illustrated.
The spindle 1008 may be provided with outward facing threads 1011 which corresponds an internally threaded recess 1012 in the piston rod 1003. The distal end of the spindle 1008 engaged into the recess 1012 of the piston rod 1003 in a manner that when the turning knob 1006 is rotated 1041 the spindle rotates 1042 and the piston rod 1003 extend and retract 1043 dependent on which way the turning knob 1006 is rotated as illustrated in figure 9.
The extending and retracting 1043 of the piston rod 1003 is provided by the feature of the piston rod 1003 further comprise longitudinal guiding protrusions or recesses 1009 which slidingly interact with corresponding internal longitudinal recesses or protrusions 1010 on the inside wall of the cylinder 1002 such that the piston rod
1003 will not rotate with the spindle 1008 when the spindle is rotated but transform the rotational movement of the spindle 1008 to a longitudinal movement of the piston rod 1003. When the cylinder 1002 is held in a fixed position relative a patient when the cylinder 1002 is connected to the patient by a holding element, for example a belt 1070, by rotating the knob will push or pull the piston rod 1003 out of/into the cylinder. Hence, the pressure element 1004 can easily be pushed or pulled towards/away from the patient.
As illustrated in detail in the exploded view in Figure 10, and the cross sectional exploded view in Figure 11 , of the first embodiment of the compression device the fixed connection of the turning knob 1006 to the spindle 1008 is provided by a first conduit 1015 through the base 1013 of the cylinder 1002 and a second conduit 1016 through the center of the turning knob 1006. In one embodiment of the connection the proximal end of the spindle is formed first closest to the threads 1011 of the spindle 1008 in a circular section 1050 having a corresponding diameter to a circular conduit 1015 through the base of the cylinder 1002. Secondly the proximal end may be formed in a cube form 1051 for inserting into a corresponding cube formed recess 1031 on the underside of the turning knob 1006. The second conduit 1016 through the center of the turning knob 1006 may be formed such that a thinner portion 1016 wider than the bolt diameter, but thinner than the bolt head 1052 leads from the top side of the turning knob 1006 to the cube recess 1031 on the underside. The thinner portion 1016 of the conduit may on the top side of the turning knob 1006 comprise a recess 1044 for partly or completely receive the bolt head 1052. The proximal end of the spindle 1008 may further comprise a centered internally threaded recess 1018 for reception of the distal end of the bolt 1007 that may have corresponding externally arranged threads 1060. Bellow holding means 1017 may be formed as a protruding disc externally formed on the outside of the cylinder 1002, being arranged between the connecting means 1005 and the end of the cylinder 1002 with the opening 1019 in the recess 1014. When the assembly of the bolt 1007, the turning knob 1006, the cylinder 1002, and the spindle 1008 is mounted together, the bolt 1007 is lead through the first and 1016 and the second 1015 conduits from the top side connecting the turning knob 1006 on top of the cylinder 1002 base 1013, and when bolt is fixed to the proximal end of the spindle 1008, for example by screwing it into the centered internally threaded recess 1018, the spindle 1008 is pulled up through the first conduit, and the second conduit such that it is fixedly connected to the turning knob, and freely rotates in the first conduit. The cube form of the recess 1031 on the underside of the turning knob 1006 receives and holds the corresponding cube form 1051 of the proximal end of the spindle 1008, and thus ensures the fixed connection between the turning knob 1006 and the spindle 1008.
It will also be understood that the connection and assembly features of the turning knob , the spindle, the piston rod and the cylinder may be arranged differently, for example by gluing, soldering or other mechanical connecting techniques.
In a further embodiment as illustrated in figure 20B, the driving means for extending and retracting 1043 the piston rod 1003 is comprised of a plunger knob 1156 arranged outside the base side 1013 of the cylinder 1002 such that it easily accessible when arranged on a patient. The plunger knob 1156 is connected to a proximal end of the piston rod via a piston extender 1155. The outside of the piston rod have proximal end facing saw tooth form 1154 corresponding to distal end facing saw tooth 1154' form formed on the inside of the cylinder 1002. Such that when pushing with a downward force on the plunger knob, the saw tooth forms
1154, 1154' of the piston rod 1003 and the cylinder 1002 interacts and ensures that the piston rod 1003 is not gliding back into the cylinder. The interacting saw tooth forms may be arranged in longitudinal sections radially spaced with a distance at least as long as the saw tooth forms (not shown), such that the piston rod 1003 can be twisted a fraction of a circle to let the saw tooth occupy a section of the cylinder 1002 not having saw tooth form and vice versa. This way it is possible to slide back the piston rod 1003 into the cylinder 1002 if needed to ease off the pressure executed by the device. In an even further embodiment as illustrated in figure 20C, the driving means for extending and retracting 1043 the piston rod 1003 is comprised of a turning knob 1006 arranged outside the base side 1013 of the cylinder 1002 such that it easily accessible when arranged on a patient. The turning knob 1006 is connected to a proximal end of the piston rod via a piston extender 1155. The outside of the piston rod have piston rod threads 1158 corresponding to cylinder threads 1159 formed on the inside of the cylinder 1002. Such that when twisting the turning knob 1006, the threads 1158, 1159 of the piston rod 1003 and the cylinder 1002 interacts and ensures that the piston rod 1003 is forced inwards/outwards of the cylinder 1002. The piston rod 1003 is in its distal end connected to the pressure element 1004 in a non-rotating coupling 1200 meaning that when the piston rod 1003 is rotating the pressure element is resting in a fixed manner on the skin of the patient.
Figures 13, 14 and 15 illustrate one embodiment of a bellow 1080, 1081 constructed to be mounted on the compression device 1001 for protecting the movable portion of the piston rod 1003 and the pressure element 1004. The bellow 1080, 1081 may be designed to cover both the side and the bottom portion of the compression device 1001 , comprising also the underside of the pressure element 1004. The bellow could be made of a durable and flexible material which is easily cleaned after each use. In a further embodiment it could be provided a bellow 1080, 1081 intended for one time use, such that cleaning process could be more efficient, and use procedure includes to mount a new bellow 1080, 1081 for each time the compression device is used. The bottom portion 1081 of the bellow 1080, 1081 may be of a material providing one or more of: non-slip surface, cushion effect, isolation to prevent "cold surface", replaceable antiseptic pad or other.
Figure 13 shows the bellow 1080 side wall in a compressed state, whilst figure 14 shows the same in an extended state, the piston rod inside being correspondingly in a retracted and extended position.
The pressure element 1004 may be provided in various sizes and dimensions, and a preferred form would be one that had a longitudinal length less than the transverse width, and more preferred form having a size of 3-7 cm in the patient longitudinal direction, and 5-9 cm in the patient transverse direction, and even more preferred form having a size of 5 cm in the patient longitudinal direction, and 7 cm in the patient transverse direction
Figure 16 illustrates the device 1001 arranged in the umbilical region of the woman/patient 1100. The cross section figures in figure 17 and figure 18 shows how the abdominal descending aorta 1120 is affected when the compression device is arranged in the umbilical region with the belt encircling the patient. When the compression device is mounted and the piston rod 1003 is in a retracted mode, the aorta 1120 is more or less unaffected, even if the compression device "bury itself to a certain degree in the "loose" umbilical area of the abdomen to the patient. When the turning knob 1006 of the compression device 1001 is turned, the piston rod 1003 is pushed outwards out of the cylinder 1002, with the effect that the aorta 1120 is pressed and squeezed towards the front of the spine 1121 , and blood flow through the aorta 1120 can be reduced or even completely stopped.
Figure 19A illustrates a method how the compression device 1001 may be operating to cut off blood stream through the abdominal descending aorta 1120 if a midwife/nursing personnel suspect that the patient suffer from PPH. Firstly the compression device 1001 must be arranged in the umbilical area of the patient, and tightly fixed. When arranged, the pressure element 1004 is extended by for example turning the turning knob 1006 of a first embodiment of the compression device 1001. The effect is that, if correctly arranged to increase the pressure on the descending aorta 1120, the blood flow through the aorta may be
stopped/decreased. The operator of the compression device 1001 typically will check the success by increasing the pressure by further operate the compression device, extending the piston stem 1003 further and confirming that the pulsations of femoral artery. This is easily observed by using the free hand 1140 to feel for pulsations of femoral artery.
It will also be understood that the holding element may be provided in other forms than the form of a belt 1070 as discussed above. For example can it be provided as a stand 1141 , 1142 or part of other treatment apparatus. A stand 1142 may be fixed to a stretcher or bed as illustrated in figure 19B where the fixed connection 1143 may be the side bars of a bed, or even the inside wall of an ambulance or the like.
The stand may even be formed to use the patient weight holding a first portion 144 of the stand, and a second portion 1141 of the stand being connected to the compression device holding it in place above the patient as coarsely described in figure 19C.
Even further embodiments of the compression device may comprise linear actuators replacing the manual driven turning knob and spindle for extending and retracting the piston stem and pressure element. Such further embodiments may be electrical or pneumatically powered. A pneumatically driven piston rod is illustrated in a non-detailed illustration in figure 20.
Such compression device as shown in figure 20 having driving means provided by a pressure chamber 1151 in the cylinder 1002 wherein the pressure chamber 1151 having a gas or fluid supply conduit 1152 for receiving or expelling pressurized 1150 gas or fluid, such that when gas or fluid is entering or exiting the pressure chamber 1151 , the piston rod 1153 expands or retracts 1043 respectively.
Electrical or pneumatic compression devices must be powered or recharged, and thus add complexity to the operation. On the other side will such powered versions of the invention also more easily provide for the ability to power for example sensors and control mechanisms for automatically adjust pressure towards the descending aorta. Sensor(s) 1045, 1046 may be arranged in the pressure element 1004 and/or in the bottom portion 1081 of the bellow or separate (not shown) to the compression device as a strap on sensor for use for example sensing the femoral artery, and sensor input may be used to control the operation of the linear actuator used to expand/retract the piston rod. The sensors may be battery operated and communicate directly with computer or handheld such as a smart phone being provided with application able to receive and handle sensor data.
Sensors 1045, 1046 in the device may also constantly sense the pressure waves through the artery and adjusts the counter pressure depending on pulse pressure. Thus, it may be possible to detect if the device is displaced under operation, and corrective actions may be quickly performed if necessary.
In a system embodiment of a powered compression device it can be provided a communication module and remote processing resources such as computers 1160 and/or handheld custom computing devices 1160 for remote surveillance/operation. Once installed to the patient the control may be managed remotely. Remote facilities may also comprise data resources and storage for storing and analyzing sensor data, and such resources may also be provided in a connected cloud 1161 computing system. The invention can also be understood to comprise the following additional embodiments:
A first additional embodiment of a compression device 1001 for external compression of the descending abdominal aorta, comprising: a cylinder 1002 defined by a base 1013 and a recess 1014 with an opening 1019, a piston rod 1003, wherein the piston rod 1003 comprise a proximal end slideably arranged via the opening 1019 in the recess 1014 of the cylinder 1002, and the piston rod 1003 further comprise a distal end connected to a pressure element 1004, the cylinder 1002 having connecting means 1005 for connecting the device 1001 to fastening means for holding the device 1001 steady when used.
A second additional embodiment of the compression device 1001 according to the first additional embodiment, wherein the device 1001 further comprising driving means for extending and retracting 1043 the piston rod 1003 out of and into the recess 1014 of the cylinder 1002. Compression device 1001 according to the first additional embodiment wherein the driving means comprise a plunger knob 1156, a piston extender 1155, wherein the plunger knob 1156 is arranged outside the base side 1013 of the cylinder 1002 and is connected to a proximal end of the piston rod 1003 via the piston extender 1155, and the outside of the piston rod 1003 having proximal end facing saw tooth form 1154 corresponding to distal end facing saw tooth 1154' form formed on the inside of the cylinder 1002, such that when pushing with a downward force on the plunger knob 1156 the saw tooth forms 1154, 1154' of the piston rod 1003 and the cylinder 1002 interacts and ensures that the piston rod 1003 is not gliding back into the cylinder 1002. A third additional embodiment of the compression device 1001 according to the second additional embodiment, wherein the interacting saw tooth forms 1154, 1154' of the piston rod 1003 and the cylinder 1002 is arranged in longitudinal sections radially spaced with a distance at least as long as the saw tooth forms, such that the piston rod 1003 can be twisted a fraction of a circle to let the saw tooth occupy a section of the cylinder 1002 not having saw tooth form and vice versa to enable slide back movement of the piston rod 1003 into the cylinder 1002.
A fourth additional embodiment of the compression device 1001 according to the first additional embodiment, wherein the driving means comprise a spindle 1008 having outward facing threads 1011 and the piston rod 1003 comprise an internally threaded recess 1012 for receiving a distal end of the spindle 1008, the piston rod 1003 further comprise longitudinal guiding protrusions or recesses 1009, the cylinder comprise internal longitudinal recesses or protrusions 1010 for sliding interaction with the corresponding longitudinal guiding protrusions or recesses 1009 of the piston rod 1003, and the spindle 1008 being rotatable connected to the piston rod 1003 such that when rotating 1042 the spindle 1008 the rotational force will translate into extending or retracting 1043 the piston rod 1003 in lateral direction in or out of the cylinder 1002.
A fifth additional embodiment of the compression device 1001 according to the fourth additional embodiment, wherein the device further comprising: a turning knob 1006 arranged outside the base side of the cylinder 1002, the turning knob 1006 being fixedly connected to the proximal end of the spindle 1008 by a connecting member 1007 wherein the fixed connection is arranged in a first conduit 1015 through the base of the cylinder 1002 and a second conduit 1016 through the turning knob 1006, such that the spindle 1008 can be rotated by turning 1041 the turning knob 1006.
A sixth additional embodiment of the compression device 1001 according to the fourth additional embodiment, wherein the device further comprising: an electrically powered linear actuator arranged outside or in the base of the cylinder 1002, the spindle 1008 being a part of the linear actuator.
A seventh additional embodiment of the compression device 1001 according to the first additional embodiment, wherein the driving means is provided by a pressure chamber 1151 in the cylinder 1002, the pressure chamber 1151 having a gas or fluid supply conduit 1152 for receiving or expelling pressurized 1150 gas or fluid, such that when gas or fluid is entering or exiting the pressure chamber 1151 , the piston rod 1153 expand or retract 1043 respectively.
An eighth additional embodiment of the compression device 1001 according to any one of the first to seventh embodiment, wherein the fastening means comprising: a holding element being connected to the connecting means 1005, and the connecting means 1005 being connected to or part of the outside mid portion of the cylinder 1002, such that when the device 1001 is arranged on a patient 1100 in the umbilical region the cylinder base 1013 facing in an anterior direction and the pressure element 1004 facing in a posterior direction, the piston protrudes inwardly pressurizing the abdomen of the patient even when the piston 1003 is in a retracted position.
A ninth additional embodiment of the compression device 1001 according to the eighth embodiment, wherein the holding element is a belt 1070 for encircling a patient 1100 in the abdomen region, and the belt 1070 is connected in both ends to connecting elements 1071 of the connecting means 1005, such that when fastened to the patient, the device 1001 can be held in place externally on the abdomen in the umbilical region.
A tenth additional embodiment of the compression device 1001 according to the eighth embodiment, wherein the holding element is a stand, and the stand is connected to connecting elements of the connecting means, such that when fastened the device can be held in place in the umbilical region of a patient.
An eleventh additional embodiment of the compression device 1001 according to the tenth additional embodiment, wherein the stand is part of a patient bed or stretcher.
A twelfth additional embodiment of the compression device 1001 according to any one of the first to eleventh additional embodiments, wherein the pressure element 1004 have a size of 5 cm in the patient longitudinal direction, and 7 cm in the patient transverse direction. A thirteenth additional embodiment of the compression device 1001 according to any one of the first to twelfth additional embodiments, wherein a bellow 1080, 1081 is arranged to cover the distal end of the piston 1003, the pressure element 1004 and a portion at the cylinder opening 1019 side of the cylinder 1002, and the bellow 1080, 1081 being attached to the outside of the cylinder by bellow connecting means 1017.
A first additional method embodiment for external compression of the descending abdominal aorta, wherein the method comprise of the following steps:
- detecting blood loss of patient indicating patient suffering post partum haemorrhage,
- arranging compression device according to any one of the first to thirteenth additional embodiments of the compression device 1001 in the umbilical region of the patient, and
- activating the driving means of the compression device to compress the descending abdominal aorta.
A second additional method embodiment for according to the first additional method embodiment, further comprising the steps:
- receive sensor data indicating displacement of the compression device, and
- correcting the placement of the compression device.
A third additional method embodiment for according to the first or second additional method embodiments further comprising the steps:
- reduce the compression pressure executed by the compression device, - administer medication intravenously to reach the uterus, and
- increase the compression pressure executed by the compression device.
A first additional system embodiment for external compression of the descending abdominal aorta, system comprising:
compression device according to any one of the first to thirteenth additional embodiments of the compression device 1001 ,
computing means for retrieving sensor data, application for processing the retrieved sensor data. A second additional system embodiment according to the first additional system embodiment, further comprising: cloud based computing
resources, and the computing means resides in the cloud.
It will be appreciated by those skilled in the art that the invention has been illustrated by describing one or more specific embodiments thereof, but is not limited to these embodiments; many variations and modifications are possible, within the scope of the accompanying claims. For example, the device may be used for other situations requiring manual aorta compression such as life-threatening penetrating trauma below the umbilicus, life-threatening blunt trauma and/or crus injuries below the diaphragm, life-threatening lower extremity haemorrhage that has failed tourniquet placement, and life-threatening junctional haemorrhage that has failed wound packing and haemostatic agents.

Claims

Claims:
1. A compression device for compression of the descending abdominal aorta of a patient comprising:
a rigid mounting member,
an extendable pressure member, and
a support structure comprising a base portion and at least two side arms connected to or arranged to be connected to the rigid mounting member, wherein the pressure member is mounted so as to be extendable relative to the rigid mounting member along an extension axis, the rigid mounting member extends laterally away from the extension axis in at least two directions and wherein the device is arranged such that when connected around the abdomen of a patient in use, the extendable pressure member is able to apply a continuous pressure to the abdomen of the patient, without the support structure applying a lateral pressure to said patient.
2. The device of claim 1 , wherein the extendable pressure member further comprises a pressure element.
3. The device of claim 2, wherein the pressure element is deformable.
4. The device of any preceding claim, wherein the connection between the support structure and rigid mounting member is releasable.
5. The device of any preceding claim, wherein the connection between the support structure and rigid mounting member is adjustable.
6. The device of any preceding claim, wherein the side arms are at least semi rigid.
7. The device of any preceding claim, wherein the base portion defines an aperture to allow access to the patient’s spine.
8. The device of any preceding claim, comprising a screw-threaded
mechanism for extending said pressure member.
9. The device of any preceding claim, wherein the extendable pressure member is provided in a housing mounted on the rigid mounting member so as to be rapidly separable from the rigid mounting member.
10. The device of any preceding claim further comprising an independent emergency pressure release arrangement for reducing or removing pressure exerted by the extendable pressure member.
11. A compression device for external compression of the descending abdominal aorta of a patient, comprising:
a mounting member defining a recess;
a pressure member comprising a pressure element at a distal end thereof mounted so as to be able to extend from or retract into the recess along an extension axis; and
a holding element connected to the mounting member so as in use to hold the mounting member steady in an umbilical region of the patient so as to allow the pressure element to apply pressure to an abdomen of the patient.
12. The device of claim 11 , wherein the mounting member is rigid and extends laterally away from the extension axis, the holding element being connected to the mounting member at a distal region thereof such that in use said pressure element is able to apply said pressure without applying a lateral pressure to said patient.
13. A compression device for external compression of the descending abdominal aorta of a patient, comprising:
a housing defining a cylindrical recess; and
a piston comprising a proximal end slidably received in the cylindrical recess and a pressure element at a distal end thereof, and
a holding element connected to the housing and arranged in use to hold the housing steady in an umbilical region of the patient so as to allow the pressure element to apply pressure to an abdomen of the patient.
14. The device of claim 13, wherein the holding element comprises a stand.
15. The device of claim 14, wherein the stand comprises a first portion arranged to be held in use by a weight of the patient and a second portion connected to the housing.
16. The device of any of claims 13 to 15, wherein the holding element comprises a hard-form belt.
17. A compression device for external compression of the descending abdominal aorta, comprising:
a housing defining a cylindrical recess; and
a piston comprising a proximal end slidably received in the cylindrical recess and a pressure element at a distal end thereof,
wherein the housing comprises connecting means for connecting the device to fastening means for holding the device in use.
18. A compression device (1001) for external compression of the descending abdominal aorta, comprising:
a cylinder (1002) defined by a base (1013) and a recess (1014) with an opening (1019),
a piston rod (1003), wherein
the piston rod (1003) comprise a proximal end slideably arranged via the opening (1019) in the recess (1014) of the cylinder (1002), and the piston rod (1003) further comprise a distal end connected to a pressure element (1004),
the cylinder (1002) having connecting means (1005) for connecting the device (1001) to fastening means for holding the device (1001) steady when used.
19. Compression device (1001) according to claim 18, wherein the device (1001) further comprising: driving means for extending and retracting (1043) the piston rod (1003) out of and into the recess (1014) of the cylinder (1002) .
20. Compression device (1001) according to claim 19, wherein the driving means comprise
a plunger knob (1156), a piston extender (1155), wherein
the plunger knob (1156) is arranged outside the base side (1013) of the cylinder (1002) and is connected to a proximal end of the piston rod (1003) via the piston extender (1155), and
the outside of the piston rod (1003) having proximal end facing saw tooth form (1154) corresponding to distal end facing saw tooth (1154’) form formed on the inside of the cylinder (1002), such that when pushing with a downward force on the plunger knob (1156) the saw tooth forms (1154, 1154’) of the piston rod (1003) and the cylinder (1002) interacts and ensures that the piston rod (1003) is not gliding back into the cylinder (1002).
21. Compression device (1001) according to claim 20, wherein
the interacting saw tooth forms (1154, 1154’) of the piston rod (1003) and the cylinder (1002) is arranged in longitudinal sections radially spaced with a distance at least as long as the saw tooth forms, such that the piston rod (1003) can be twisted a fraction of a circle to let the saw tooth occupy a section of the cylinder (1002) not having saw tooth form and vice versa to enable slide back movement of the piston rod (1003) into the cylinder (1002).
22. Compression device (1001) according to any of claims 19 to 21 , wherein the driving means comprise
a spindle (1008) having outward facing threads (1011) and the piston rod (1003) comprise an internally threaded recess (1012) for receiving a distal end of the spindle (1008),
the piston rod (1003) further comprise longitudinal guiding protrusions or recesses (1009),
the cylinder comprise internal longitudinal recesses or protrusions (1010) for sliding interaction with the corresponding longitudinal guiding protrusions or recesses (1009) of the piston rod (1003), and the spindle (1008) being rotatable connected to the piston rod (1003) such that when rotating (1042) the spindle (1008) the rotational force will translate into extending or retracting (1043) the piston rod (1003) in lateral direction in or out of the cylinder (1002).
23. Compression device according to claim 22, the device further comprising: a turning knob (1006) arranged outside the base side of the cylinder (1002), the turning knob (1006) being fixedly connected to the proximal end of the spindle (1008) by a connecting member (1007) wherein the fixed connection is arranged in a first conduit (1015) through the base of the cylinder (1002) and a second conduit (1016) through the turning knob (1006), such that the spindle (1008) can be rotated by turning (1041) the turning knob (1006).
24. Compression device according to claim 23, the device further comprising:
an electrically powered linear actuator arranged outside or in the base of the cylinder (1002), the spindle (1008) being a part of the linear actuator.
25. Compression device according to any of claims 18 to 21 , wherein the driving means is provided by a pressure chamber (1151) in the cylinder (1002), the pressure chamber (1151) having a gas or fluid supply conduit (1152) for receiving or expelling pressurized (1150) gas or fluid, such that when gas or fluid is entering or exiting the pressure chamber (1151), the piston rod (1153) expand or retract (1043) respectively.
26. Compression device according to any one of claims 18 to 25, wherein the fastening means comprising: a holding element being connected to the connecting means (1005), and the connecting means (1005) being connected to or part of the outside mid portion of the cylinder (1002), such that when the device (1001) is arranged on a patient (1100) in the umbilical region the cylinder base (1013) facing in an anterior direction and the pressure element (1004) facing in a posterior direction, the piston protrudes inwardly pressurizing the abdomen of the patient even when the piston (1003) is in a retracted position.
27. Compression device according to claim 26, wherein the holding element is a belt (1070) for encircling a patient (1100) in the abdomen region, and the belt (1070) is connected in both ends to connecting elements (1071) of the connecting means (1005), such that when fastened to the patient, the device (1001) can be held in place externally on the abdomen in the umbilical region.
28. Compression device according to claim 26, wherein the holding element is a stand, and the stand is connected to connecting elements of the connecting means, such that when fastened the device can be held in place in the umbilical region of a patient.
29. Compression device according to claim 28, wherein the stand is part of a patient bed or stretcher.
30. Compression device according to any one of claims 18 to 29, wherein the pressure element (1004) have a size of 5 cm in the patient longitudinal direction, and 7 cm in the patient transverse direction.
31. Compression device according to any one of claims 18 to 30, wherein a bellow (1080, 1081) is arranged to cover the distal end of the piston (1003), the pressure element (1004) and a portion at the cylinder opening (1019) side of the cylinder (1002), and the bellow (1080, 1081) being attached to the outside of the cylinder by bellow connecting means (1017).
32. A method for external compression of the descending abdominal aorta, wherein the method comprise of the following steps:
detecting blood loss of patient indicating patient suffering post partum haemorrhage,
-arranging compression device according to any one of previous claims 21 to 33 in the umbilical region of the patient, and
activating the driving means of the compression device to compress the descending abdominal aorta.
33. Method according to claim 32, further comprising the steps:
receive sensor data indicating displacement of the compression device, and correcting the placement of the compression device.
34. Method according to claim 32 or 33, further comprising the steps: reduce the compression pressure executed by the compression device, administer medication intravenously to reach the uterus, and
increase the compression pressure executed by the compression device.
35. System for compression exterior abdomen of the descending abdominal aorta, system comprising:
compression device according to any one of previous claims 18 to 31 , computing means for retrieving sensor data,
application for processing the retrieved sensor data.
36. System according to claim 35, further comprising:
cloud based computing resources, and the computing means resides in the cloud.
PCT/GB2020/051788 2019-07-26 2020-07-24 Device, method and system for compressing the descending abdominal aorta WO2021019221A1 (en)

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