Guidance device for ultrasonography guided device placement

专利摘要:
A guidance device for ultrasonographic guidance of percutaneous placement of an occlusion device in a subject adapted for placement against the body of the subject essentially at a desired percutaneous insertion site for the occlusion device is disclosed. The guidance device comprises a directing member adapted to receive an introducer for percutaneous insertion of an occlusion device into a blood vessel of the subject. The directing member is oriented such that said introducer received in the directing member provides for insertion of the occlusion device along a first axis. The guidance device is adapted to receive and releasably hold an ultrasonographic imaging probe to obtain an image having an imaging plane. Further, the guidance device is arranged to hold the ultrasonographic imaging probe such that the first axis of the directing member is positioned in a plane that is essentially perpendicular to the imaging plane, and the directing member is coupled to the guidance device via an attachment member such that the directing member is configured to be movable only in the plane that is essentially perpendicular to the imaging plane.A guidance assembly comprising a guidance device also comprises an occlusion device for occluding a blood vessel of a subject, as well as an introducer, and is packaged in a suitable container.Fig. 1a
公开号:SE1551145A1
申请号:SE1551145
申请日:2015-09-08
公开日:2017-03-09
发明作者:Fjetland Lars；Roy Sumit；Petter Oveland Nils
申请人:Helse Stavanger Hf；
IPC主号:

专利说明:

TitleGuidance device for ultrasonography guided device placementField of the inventionThe present invention relates to a guidance device for ultrasonography guided placement ofa medical device, and a guidance assembly including such a guidance device, according tothe preamble of the independent claim.
Background of the inventionTrauma is among the most common causes of mortality worldwide, accounting for about atenth of the deaths occurring every year. ln almost half the cases, loss of life after traumacan be ascribed to uncontrolled bleeding. Both blunt and penetrating injuries can causeserious internal bleeding, that not infrequently may be difficult to detect, and very oftenrequires a major surgical procedure to stop. Therefore, even today, the immediatemanagement of a severely bleeding victim of trauma, whether for example on the battlefieldor at the site of a traffic accident, represents a major challenge. All that can be presentlyoffered is intravenous infusion of fluids, external compression devises such as pelvic binders,inflatable trousers and tourniquets (abdominal, junctional and for extremities), followed byand very rapid transfer to the nearest trauma hospital. As the latter is frequently not possibleeven with access to the best logistics, not unsurprising a large number of trauma victimsaround the world simply bleed to death. A large majority of these would probably escape thisfate if the bleeding could be halted before the patient is moved from the site of trauma.
One technique for lessening or stopping excessive bleeding is resuscitative endovascularballoon occlusion of a blood vessel, commonly of the aorta or downstream of the aorta. Thisprocedure is commonly abbreviated REBOA (“Resuscitative Endovascular Balloon Occlusionof the Aorta”). A balloon catheter is inserted one of the femoral arteries in the groin of asubject, and threaded up to the aortic bifurcation. Here the balloon is inflated to stop bloodflow to the pelvic area. ln many cases this is sufficient to avoid a catastrophic fall in bloodpressure and restore central perfusion to vital organs such as the heart and brain, and toallow enough time for transport to a hospital. However, if the hemodynamic response is notsatisfactory, the balloon can be deflated, repositioned and re-inflated higher up in the aorta.Hereby, also the blood supply to the kidneys and the gastrointestinal tract, via the visceralarteries, is hindered; further stopping any excessive bleeding out, and allowing blood to beconcentrated to the brain and heart. Thereafter the patient can be transported to medicalfacilities for surgical measures.
The biological principles underlying REBOA are very well known. Severe bleeding leads torapid reduction in circulatory blood volume. Loss of over 30-40% of the blood volume leadsto circulatory collapse and death. Bleeding of this magnitude unfortunately cannot becompensated for by intravenous infusion of fluids. REBOA on the contrary offers an eleganttherapeutic solution. Since the aorta is the sole source of blood to the body, halting aorticblood flow upstream of a bleeding artery leads to immediate reduction of flow in the latter, tothe extent that bleeding ceases or is reduced to a negligible level. And as a bonus, the bloodremaining in circulation is redistributed to more vital organs such as the heart, the brain andthe kidneys.
As an example, a retrospective analysis of data in the UK Joint Theatre Trauma Registryrevealed that 20% of military personnel with severe combat injuries would have beencandidates for REBOA (Morrison JJ. Shock 2014; 412388-93). With conventional treatment,70% of them died, most of them before they could be transferred to a hospital.
REBOA was first described in 1954 by an American military surgeon treating battlecasualties in the Korean War (Hughes CW. Surgery 1954; 36:65-8). Since then a number ofarticles have appeared in literature focusing on use of the procedure during aortic surgery(Hesse FG. Ann Surg 1962; 1552320-2. Howard ER. BMJ 1971; 3(5767):161), upperabdominal surgery (Miura F. J Gastrointest Surg 2006; 10:519-22), and for treating patientswith severe bleeding from the uterus (Harma M. Obstet Gynaecol 2004; 44:170-1), as well asafter pelvic injuries (Martinelli T. J Trauma 2010;68:942-8).
Many documents describe different types of balloon catheters for occluding vessels and foruse in various other procedures. International patent application WO 2011/133736 describesan endovascular aortic occlusion system comprising a balloon catheter for occluding thethoracic aorta. US patents 5,334,142 and 5,437,633 both disclose similar devices comprisingballoon catheters for occluding the aorta during CPR, and further comprising means forinfusing oxygenated fluid into the aorta above the occluded balloon.
Ultrasonography is commonly used for guiding puncture and introducer placement in bloodvessels. US Patent Application 2002/0026117 shows a medical probe for ultrasound guidedinsertion of a medical device. US Patent Application 2012/016679 discloses a device fororthogonal ultrasonography guided puncture.
Despite its obvious advantages, REBOA has unfortunately found very little use in general,and in pre-hospital settings, REBOA is practically unknown. REBOA can be performed with2commercially available products (Stannard A. J Trauma 2011; 71 :1869-1872). Nonethelessthese were designed to be used in a suitably large sterile operative field, by doctors with thetraining and experience to perform catheter-based, i.e. endovascular, procedures. Out in thefield or in an emergency room, space is at a premium, and a sterile environment can be hard,if not impossible, to achieve, and the personnel may have little endovascular experience.Thus, there is a need for a solution allowing an easier and safer way of performing REBOA,especially outside medical facilities, such as at accident sites or in military settings.
Summary of the inventionAn object of the present invention is to provide a guidance device providing a rapid non-surgical access to the vascular system in a subject.
A further object of the present invention is to provide a REBOA guidance assemblycomprising a guidance device that allows a REBOA procedure to be performed inhygienically challenging environments.
The above-mentioned objects are achieved by the present invention according to theindependent claim. Preferred embodiments are set forth in the dependent claims.
A guidance device for ultrasonographic guidance of percutaneous placement of an occlusiondevice in a subject adapted for placement against the body of the subject essentially at adesired percutaneous insertion site for the occlusion device is disclosed. The guidancedevice comprises a directing member adapted to receive an introducer for percutaneousinsertion of an occlusion device into a blood vessel of the subject. The directing member isoriented such that said introducer received in the directing member provides for insertion ofthe occlusion device along a first axis. The guidance device is adapted to receive andreleasably hold an ultrasonographic imaging probe to obtain an image having an imagingplane. Further, the guidance device is arranged to hold the ultrasonographic imaging probesuch that the first axis of the directing member is positioned in a plane that is essentiallyperpendicular to the imaging plane, and the directing member is coupled to the guidancedevice via an attachment member such that the directing member is configured to bemovable only in the plane that is essentially perpendicular to the imaging plane.
A guidance assembly comprising a guidance device also comprises an occlusion device foroccluding a blood vessel of a subject, as well as an introducer, and is packaged in a suitablecontainer.
Short description of the appended drawinqsFigure 1 shows a guidance device for ultrasonography guided catheter placement.Figure 2 shows a guidance device placed in the intended area of use on a body.
Figures 3a-3c illustrate the relationship between ultrasound imaging plane and a guidancedevice.
Figure 4 shows an occ|usion device for occ|uding a blood vessel.
Figure 5 shows a guidance assembly for ultrasonography guided device placement.Figure 6 shows another guidance assembly for ultrasonography guided device placement.
Figures 7a-7c illustrate the use of a guidance assembly for ultrasonography guided deviceplacement.
Detailed description of the inventionPhysicians and paramedics who deal with casualties of accidents, whether in a civilianenvironment, or on the battlefield, as well as acute care specialists and any medicalpersonnel who deal with patients with uncontrollable bleeding trauma, including trauma andvascular surgeons, gynecologists, interventional radiologists and anaesthesiologists, wouldbenefit from an improved device for quickly and safely performing REBOA. ln suchsituations, rapidly halting blood flow in the aorta is essential.
One challenge in performing REBOA in non-hospital or emergency settings is havingpersonnel on hand who are trained in performing REBOA, which is a relatively complicatedand invasive procedure. One of the critical steps of performing REBOA is gaining access tothe femoral artery in the groin for placement of an occ|usion device in the aorta. Under thebest of circumstances, there is always a risk of incorrect puncture, uncontrolled bleeding, orsimply not placing the introducer for access in the correct vessel. One common problem isaccidently placing the puncture and introducer in the femoral vein, instead of the femoralartery, as the two run alongside each other in the groin.ln addition, accessing the femoral artery in the groin area can be especially difficult in atrauma patient who has sustained any number of injuries, resulting in bleeding, broken bonesand injured internal organs. A common procedure in e.g. traffic accidents is to place a so-called “pelvic binder” around the pelvis of the patient, to stabilize any fractures in the pelvicbones. The pelvic binder is a belt that is placed around the patient's pelvis and applies anexternal circumferential pressure to stabilize any pelvic fractures. This will be described inmore detail below. Thus, accessing the groin area, and performing a procedure that includesentering the large femoral artery is complicated in a trauma situation, and can be verystressful for a clinician to perform.
An additional challenge is to have all the necessary components within reach, and a furtherchallenge is keeping such components and the area of use sterile, all while working in a dirtyand/or contaminated as well as stressful environment. To perform REBOA, severalcomponents are needed, such as an occlusion device, an ultrasound probe and device forviewing the entry site, a long guide wire for introducing the occlusion device, an introducer, aneedle or other device for penetrating the skin, means for inflating the balloon etc. All thecomponents need to be handled in a sterile manner to prevent contamination and infection.
Moreover, as is well known, massive internal bleeding, with consequent deterioration ofcardiovascular status, can occur due to any of a number of conditions not related to trauma.ln the absence of a satisfactory alternative, urgent surgery is often resorted to in thesepatients. Not surprisingly, the outcome is not infrequently far from satisfactory, becauseunstable cardiovascular parameters make these patients particularly ill-suited for surgicalintervention, especially including an anesthesia procedure. Routine preliminary REBOA inthese patients has the potential to dramatically improve their prognosis. Thus, also in suchhospital settings, REBOA could be used to save lives if there was a way of carrying out theprocedure that was easier to learn and perform.
A guidance device is presented here, which offers such a solution. ln Figure 1a, a guidancedevice 1 for ultrasonographic guidance of percutaneous placement of an occlusion device ina subject is shown in a perspective side view. The guidance device 1 comprises a directingmember 2 for an introducer for percutaneous insertion of an occlusion device into a bloodvessel of a subject, wherein the guidance device and the directing member are arranged toassist a user in percutaneous insertion of said introducer into said subject.ln the present disclosure, the relative term “proximal” refers to a direction or part of a deviceor component being closest to a user, and thus ”distal” refers to a direction or part of a devicebeing farther away from a user. This is particularly applicable to e.g. an introducer foraccessing a blood vessel percutaneously or to a catheter device, such as that used in theREBOA procedure, wherein the distal end is inserted first into a patient, and, during use, isthe end which reaches farthest into the vascular system. The proximal part of an introduceror catheter is that which normally remains outside the patient.
Herein is also referred to other relative directions which will become clear from thedescription. ln general, it is assumed a patient is lying on his/her back on a horizontalsurface, and the guidance device is placed in one of the groins of the patient, as illustrated inFigure 2, which shows a schematic top view (generally from above the patient) of a guidancedevice, and how it is intended to be placed in the groin area.
Thus, in use, the guidance device 1 is placed in the groin area with the backside 3 againstthe skin of the patient, and the directing member 2 extending towards the foot of the subjector patient. This is illustrated in Figure 2. Preferably, the guidance device is secured to thepatient. This can be done by simply taping or strapping down the guidance device on theupper thigh of the patient. The guidance device can also be provided with attachment meanssuch as straps, such as Velcro-straps or self-adhesive straps, for attachment to the patient.Notably, in trauma situations where REBOA is indicated as a suitable procedure, the patientoften has pelvic bone injuries. Thus, a common procedure in such situations is to secure aso-called “pelvic binder” around the pelvis of the patient, to stabilize the pelvic region. Apelvic binder 14 is a wide belt, and covers the pelvis of the patient, which is schematicallyindicated in Figure 2. Thus, access to the groin area is limited. The present guidance device1 is adapted to this situation, in that it is small but adapted to fit over a suitable entry site foraccessing the femoral artery.
Thus, the guidance device 1 is adapted for placement against the body of the subjectessentially at a desired percutaneous insertion site for an occlusion device. This will beexplained further below.
The guidance device 1 is also adapted to receive and releasably hold a probe 10 forultrasonographic imaging during insertion of an introducer into a blood vessel, as is shown inFigure 1b. For comparative purposes, in Figure 1a, the probe 10 and its intended insertiondirection into the guidance device is shown in dotted lines. Thus the guidance device has acavity 4 formed by a surrounding bracket structure for receiving a distal end of an ultrasoundprobe 10, where the cavity 4 is adapted to accommodate a number of different availableultrasound probes 10. The side of the guidance device facing the patient, i.e. at the bottom ofthe cavity, is sonolucent, i.e. allows ultrasonographic imaging of underlying structures. As analternative, only a central part of the bottom of the cavity is sonolucent, such that onlystructures which are in the middle of the field will be visible. Restricting the field of viewallows for optimal placement of a probe 10, as well as keeping the probe in an optimalposition during the following procedures, as will become clear from the details describedbelow of the relationship between the resulting image and the angle of penetration directedby the directing member.
The bottom of the cavity 4 can optionally be provided with a sonolucent adhesive forimproved hold of a probe in the cavity.
Common ultrasonography probes have a generally oblong distal end, wherein the longercentral axis of the oblong shape defines the imaging plane of the resulting image. Theultrasonographic probe has a leading surface, wherein the leading (distal) surface does notappreciably hinder the passage of sound waves emitted by the probe, i.e. the probe has adistal sonolucent surface. Thus, an important feature of the guidance device 1 is to align thereceived probe 10, regardless of type, such that an imaging plane 11 is obtained in adirection transverse to underlying major blood vessels of a groin area. ln the top view ofFigure 2, the resulting imaging plane 11 of a probe inserted into the guidance device 1 isindicated with a dotted line. The femoral artery 12 is also shown in dotted line. The presentinventors have realized that using a transverse cross-section for ultrasonography imaging ofthe major femoral blood vessel provides for a technique in guiding puncture of the desiredvessel which is easier to learn and better suited especially for less experienced users, suchas first responders at an accident site. The advantages will be further described below.
The guidance device may also comprise a probe cover 15 as shown in Figure 1b. The probecover 15 is a generally tube-shaped transparent cover to isolate the ultrasonography probefrom the sterile field surrounding the guidance device. The distal end of the probe cover 15is attached to the bracket surrounding the cavity 4 such that probe can be inserted into thecavity 4 without contaminating the sterile field. The directing member 2 is arranged outsidethe probe cover 15.
Using the guidance device 1 as described above helps align the path of an introducer with asuitable entry path into a femoral artery 12 of a subject. Hence, the guidance device 1 isarranged to hold the probe 10 for ultrasonographic imaging such that the longitudinal axis Aof the directing member 2 is positioned in a plane that is essentially perpendicular to theimaging plane 11. Further, as can be seen in Figure 2, the directing member thereby also ispositioned in a second plane 16 that is essentially aligned with the femoral artery 12 whenthe device is placed in position on a patient. Further, the directing member 2 is configured tobe movable only in the plane 16 that is essentially perpendicular to the imaging plane, i.e. upand down to adjust the depth angle of penetration, as will be explained further below. This isachieved by coupling the directing member 2 to the bracket of the guidance device via anattachment member 5, such as a hinge or similar attachment.
The directing member 2 may be a generally tubular structure, as shown in e.g. figures 1a and1b. As an alternative, a directing member can comprise an open structure with one or severalgrooves or pre-formed slots in an upper surface (not shown), wherein the grooves or slots7are adapted to accommodate a needle or introducer and direct insertion in the intendeddirection. Such an open structure can similarly be coupled to the bracket of the guidancedevice via an attachment member via hinge or similar structure, or comprise a fixed structureon the outside of the guidance member. Each groove or slot will define a longitudinal axis ofthe directing member and be positioned in a plane that is essentially perpendicular to theimaging plane. Each groove or track may be marked with a visual indicator of the depth ofpenetration when using such groove or slot.
Notably, even though the general structure of the guidance device and especially the cavitywill fit most common ultrasonography probes, the guidance device can further be providedwith one or several probe adapters, i.e. structures that fit into the cavity and have an adaptedupper surface to accommodate specific shapes of the distal leading edges of a probe. Suchadapters are preferably held in the cavity by friction, or by an adhesive.
The guidance device 1 is configured to be placed by a user in the groin of a subject at e.g. anaccident site. The outside of the guidance device 1, especially the backside 3, i.e. the sideadapted to be placed on the subject, can be shaped such that it corresponds to the generalshape of a human or mammalian groin area. A guidance device 1 may be adapted to beplaced at or slightly below the fold betNeen the upper thigh and the abdomen, and generallyresting against the upper thigh.
As an alternative the guidance device can be mounted on a support or plate. Preferably,such a support has a generally rounded shape, to adapt to the shape of an upper thigh.
The two largest vessels in the groin area are the femoral artery 12 and the femoral vein 13.ln Figures 3a and 3b, three exemplary different possible depths of these two vessels underthe skin are shown in relation to corresponding longitudinal axes A of a directing member. Asseen in Figure 3b, the two major vessels will be displayed next to each other as circular blackstructures on the imaging plane in when using the guidance device.
Figure 3a shows a guidance device 1, with an ultrasonography probe 10 inserted into it.Below the guidance device 1 is shown a vertical line, indicating the imaging plane 11 of theultrasonography probe. ln Figure 3b, a corresponding resulting image is shown. Theguidance device is placed in the groin area of the patient, and in Figure 3a is seen a planedefined by the directing member 2, having a longitudinal axis A, and the underlying thefemoral artery 12. lt is to be noted that there is normally only one femoral artery 12 in eachgroin of a patient, however, in Figures 2a and 3b, three different exemplary depths of thefemoral artery 12 is shown.
As is illustrated in Figure 2, due to the configuration of the guidance device 1 and thedirecting member 2 for an introducer, when the guidance device 1 is placed in the groin areaof a subject, it provides a preset placement position for an u|trasound probe 10. Further, italso aligns the directing member 2 towards a suitable entry point into the femoral artery 12.Due to the configuration of the guidance device, the projected entry direction of a needle oran introducer, along a longitudinal axis A, will transversely cross the imaging plane 11 of theu|trasound probe, i.e. the direction of introduction of the introducer will be out-of-plane inrelation to the imaging plane 11. This imaging plane 11 has the further advantage of beingable to visualize both the femoral artery 12 and the femoral vein 13 in the same image, asillustrated in Figure 3b. Thus, a user can ensure that the introducer is introduced into thefemoral artery 12, and not the femoral vein 13 (or other vessels), as both can be visualized atthe same time, in the same imaging plane.
The direction of the directing member is thus configured to be adjustable in a vertical planethat is perpendicular to the imaging plane 11. Referring to figure 1, this can be accomplishedby attaching the directing member 2 with a hinge 5 or similar connection means to theguidance device 1, such that the directing member 2 can be adjusted up or down, i.e.increasing or decreasing the angle of penetration into the underlying subject. This allows on-site adjustment due to individual patient body types, without compromising the guidingfunction of the guidance device.
As an alternative, a guidance device can comprise a directing member having one or severalslots or grooves for inserting a needle or introducer in a fixed angle. One example is shownin Figure 3c. Such fixed slots can be color-coded or marked to correspond to specifieddepths and/or regions of an u|trasound image.
The guidance device may be used in a REBOA procedure, for guiding an occlusion devicesmoothly, safely and securely into a percutaneous entry site into a femoral artery.
Figure 4 shows an occlusion device 20 for occluding a blood vessel and for use with thepresent guidance device. The occlusion device 20 may comprise an elongated catheter 21having a distal end 22 and a proximal end 23, where the catheter comprises at least a firstballoon 24 adapted to occlude a blood vessel when in an expanded or inflated state.
The occlusion device can be adapted to be used together with a separate guide wire.However, preferably, the occlusion device can comprise a flexible, preferably J-shaped,guide wire part 26 forming a distal tip of the occlusion device 20. An occlusion device canthus comprise a J-shaped guide wire part 26 arranged distally of the catheter 21 andattached to the distal end of the catheter to extend distally therefrom and form a distal tip ofthe occlusion device. This allows the occlusion device to be safely advanced though thepelvic arteries to the aorta without the need for a long guide wire. Such an integrated guidewire also has the advantage of making it easier to keep the occlusion device and othercomponents sterile, as no long guide wire needs to be handled outside the patient. lnaddition, one step in the procedure, i.e. having to first insert a guide wire and thereafter theocclusion device, can be eliminated.
An occlusion device 20 can also comprise a second balloon 25 adapted to occlude a bloodvessel when in an expanded state. Preferably, the first and second balloons are arrangedsuch that each can be expanded separately, e.g. via separate entry ports 27, 28 in theproximal end 23 of the occlusion device 20. The first balloon 24 is arranged such that it canbe placed in the abdominal region of the aorta, and the second balloon 25 is arranged suchthat it will be located in the upper, thoracic, part of the aorta when the first balloon 24 is in theabdominal region of the aorta. The advantage of arranging two balloons in such a way on theocclusion device is that the first balloon can be inflated in the abdominal region, and if thisprocedure is not sufficient to stop bleeding to an acceptable level, the second balloon can beimmediately inflated in the upper aorta. Thus, a step of deflating and repositioning a balloonis eliminated, saving valuable time.
An example of an occlusion device, or REBOA catheter, for use with the guidance device isdescribed herein. However, this is only an example of the type of device which can be used.A REBOA catheter may be approximately 50 cm to 70 cm long, preferably approximately 60cm long. lt can comprise tNo occlusion balloons and a coaxial guidewire. The outer diameterof the catheter shaft may be 2,3-2,7mm (7-8 Fr). The shaft may be reinforced to resistbuckling in response to the strong axial forces on a balloon obstructing blood flow in theaorta.lf a separate guidewire is used, the guidewire may be approximately 70 cm long, and 0,89mm (0.035 inches) in diameter. The leading end of the guidewire may be J-shaped (diameterJ 7-10mm), and protrude from the tip catheter, while the trailing end is reversibly secured tothe catheter's hub. As alternative, an integrated distal guide wire tip may be used, asdescribed above, with similar diameter and J-shapes tip. An integrated guide wire tip ispreferably approximately 8-15 cm long.
The REBOA catheter may be a triple lumen catheter, and may comprise a coaxial innerrelatively stiff cannula. The cannula prevents the catheter from buckling in response to thestrong axial hemodynamic forces generated in the aorta when flow through it is halted.
The inflation channel for each balloon exits the catheter shaft in the form of a side-arm 27, 28attached to the proximal end of the catheter. Each side are may be labelled e.g. "THORAX"and “ADBOIVIEN” and/or color-coded (e.g. red and blue or other contrasting colors orpatterns) as appropriate, to enable the user to quickly identify the desired channel to connectto for inflation of a specified balloon. To inflate the balloons syringes prefilled with sterilesaline may be used by attaching a syringe to the appropriate sideport 27, 28.
The catheter may also have on or more sideports for rapid infusion of fluids including bloodor blood products. Thus, the catheter can be used both for occluding blood vessels, such asthe aorta, and simultaneous infusion of e.g. blood, blood products or oxygenated fluid abovethe occluded vessel. Such infusion can thus at least partially replace the lost blood andimprove oxygenation of the upper parts of the body, including vital organs such as the heartand brain.
The occlusion balloons can be independently inflated of the other, as indicated above. Thusflow in the can be halted at different levels in the aorta allowing bleeding from both the upperbranches and the lower branches of the aorta to be treated without moving the catheter. Asan example, the distal balloon 25 (thorax balloon) may be mounted approximately 2 cm fromthe leading, or distal, end of the catheter. The length of the balloon may be about 4cm. Theouter diameter of the catheter at the level of the balloon preferably does not exceed 3 mm (9Fr). The proximal balloon 24, the abdomen balloon, may be mounted at a distance of 20 cmfrom the thorax balloon.
An occlusion device can further comprise a pressure sensor adapted to measure bloodpressure via the elongated catheter. Thus, an inline pressure transducer can be mountednear the proximal end of the catheter, with an integrated display provided at the proximal hubfor continuous monitoring of blood pressure via catheter. As an alternative, a pressuresensor can be mounted at a distal end of a catheter. Data from the sensor may betransferred through cable that runs in wall of the shaft of the catheter and exits it at its trailingend of the catheter. The cable serves is provided with a plug to connect to a pressuremonitor.
A guidance device as described above can be an integrated part of a guidance assembly forperforming occlusion of a blood vessel. Such an assembly is optimized for field use andtrauma situations, and further comprises an occlusion device for occluding a blood vessel ofa subject, for example an occlusion device as described above. Moreover, the guidanceassembly comprises at least an introducer for percutaneous insertion of the occlusion deviceinto a blood vessel of a subject.11The assembly can be packaged in a suitable case or container. A non-limiting example is arobust, disposable, water-proof multifunctional case made from a preferably pathogen-proof,non-allergenic, sterilizeable material. The material is preferably also light-weight. Thecontainer should preferably be large enough to carry a REBOA catheter and associatedaccessories, yet small enough to be comfortably transported by a paramedic, preferablyhand carried.
The content of such a case, i.e. a guidance assembly, is schematically illustrated in Figure 5.Another example is shown in Figure 6a and 6b. The assembly 30,40 comprises an introducerand/or needle for puncture of the skin, a dilator to widen the entry hole, an occlusion deviceas previously described and preferably two-prefilled syringes for inflating the balloons. Allcomponents are releasably attached to the bottom of the case. Other accessories such as atleast a pair of sterile gloves, sterile ultrasound gel and sterile wipes or sterile fluid can beprovided in the assembly. The case 30, 40 is adapted to be opened and folded out to theillustrated configuration, directly on the patient's body. See Figure 7a-7c for the use of suchan assembly. Integrated in the assembly, at an upper part in Figure 5, i.e. to be placed in thedirection of the patient's head, is a guidance device 1 for ultrasonographic guided placementof a REBOA catheter as described above. The guidance device 1 is designed to beadaptable to an ultrasonographic probe irrespective of vendor as previously described.
The case may be provided with means to atraumatically secure it to the thigh of the patient,at the start of the REBOA procedure. The attachment means can be any suitableattachment means, such as a belt or band comprising Velcro, fasteners, clasps and/orbuttons. The case can be securely fixed to the patient's thigh irrespective of the size of thelatter, such that all its contents are easily accessible to the operator. An example of aguidance assembly and how it is placed in relation to a patient is shown in Figures 7a-7b.
The case may so designed that on opening it, an adequately large sterile working areabecomes available to the operator. Additional flaps 31, 41 can be provided, such that onfolding out the flaps from the case, a larger sterile working area becomes available. Further,as described for the guidance device 1 above, on securing the case to the patient and foldingout the contents, the guidance device 1 will be in position to guide the entry into the femoralartery, as described above and seen in Figure 7b. Hence, once the case is in place on thethigh, the guidance device 1 will be automatically located at the groin for arterial puncture asdescribed above. Moreover, the guidance assembly can preferably comprise also at least apair of sterile gloves, sterile ultrasound gel and sterile wipes or sterile fluid to make theprocedure as safe in terms of contamination as possible.12The guidance device 1 may be attached to the case such that it can be rotated and/or movedin all axes in the horizontal plane defined by the backside of the guidance device, to allow itto be optimally placed with relation to the artery to be punctured.
As described above, contrary to other ultrasound products on the market, the guidancedevice 1 allows arterial puncture using “out-of-plane” technique. Based on the experience ofthe inventors, this technique is far easier to learn than its conventional “in-plane” counterpart,and significantly reduces the risk of inadvertent catheter placement in the large vein whichruns parallel to the femoral artery in the groin.
As described above, the needle trajectory can be changed depending on the depth of theartery to be punctured, by attaching the directing member such that is adjustable to increaseor decrease the depth angle of penetration. This adjustment direction can be defined asbeing in a plane 16 perpendicular to the imaging plane 11.
To inflate the balloons, syringes prefilled with sterile saline may preferably be provided in theguidance assembly. These syringes may be pre-marked for inflation of the first or secondballoon. A flow switch and a pressure gauge may be attached to the nozzle of the eachsyringe. As an alternative, syringes prefilled with sterile fluid and micro-bubbles may be used.
By inflating the balloons with micro-bubbles they become more visible for ultrasoundscanning. Thus, the post-REBOA procedure position of the balloons within the aorta can bemore easily controlled with ultrasound scanning if the balloons have been inflated with micro-bubbles.
A method of use of the guidance assembly and a double balloon REBOA catheter isdescribed below and illustrated in Figures 7a-7c. A guidance assembly is placed in the groinarea of the patient, as described above. Preferably the assembly is immobilized on apatient's thigh by means of e.g. Velcro, straps, adhesive or a combination thereof. The caseis opened (Figure 7b) and the guidance device will be located over the groin as described inconnection to Figures 2-3 above. Preferably, sterile drapes 31, 41 (not shown in Figures 7a-7c, but as shown in Figures 5 and 6a) are folded out to create a larger sterile fieldsurrounding the case, covering the upper thighs and lower abdomen of the patient.
Thereafter an ultrasound probe 10 is placed in the guidance device 1. lf a probe cover isprovided, such is pulled or rolled up over the probe. The groin is scanned with theultrasonography probe held perpendicular to the groin by the guidance device 1, and thusperpendicular to the anticipated course of the common femoral artery. Once the artery isidentified, the position of the probe is adjusted until the artery appears in the middle of theimage as a circular structure. Depending on the distance between the skin surface and the13artery the angle for insertion of the needle is selected and the depth of needle estimated. Aneedle is inserted through the directing member 2. A Chamber or reservoir to collect theblood (not shown) that comes out of the needle is attached to the hub of a needle of suitablediameter and length. The needle is inserted through the skin and slowly advanced until its tipappears on the image on the surface of the artery. The needle is advanced into the artery.Once there is a brisk flow of blood from the needle, the guidance device is separated fromthe needle. Using the well-known Seldingertechnique, an occlusion device introducer isplaced in the femoral artery. lf the back flow from the needle is not satisfactory, the reservoirmay be removed and a pressure transducer coupled to the needle to confirm that its tip is inthe artery. The occlusion device, with the occlusion device guide in situ, is advanced throughthe introducer, until as seen using the depth markers on the occlusion device shaft, theocclusion balloon is within the aorta. The balloon is slowly inflated, while the pulse in theopposite groin is felt. Loss of the pulse confirms that the catheter is correctly located.
Hence, under ultrasound guidance, as described above, a needle is inserted through thedirecting member 2, to create a skin puncture. Thereafter an introducer can be insertedthrough the puncture and into the femoral artery.
As outlined above, during REBOA, the balloon catheter will be non-surgically introducedunder ultrasound guidance into the femoral artery in one of the groins through a tiny openingin the skin (Figure 7c). The catheter is advanced until the abdomen balloon, i.e. the proximalballoon, reaches the aortic bifurcation. The cable is connected to a pressure monitor. Theabdomen balloon is thereafter inflated using a pre-filled syringe, stopping blood flow to thepelvis. lf hemodynamic response is not satisfactory, indicating that the site of bleeding is inthe upper abdomen, the thorax balloon, i.e. distal balloon, will be inflated. Based on theinventors experience and that reported in literature, these few steps are sufficient topractically eliminate the risk of catastrophic fall in blood pressure and thereby allow enoughtime for transport to a hospital. This is true even in patients in whom the source of bleeding isnot in the abdomen, as stopping blood flow to the latter leads to redistribution of blood tomore vital organs such as the brain and the heart.
All the parts needed to perform the REBOA procedure are preferably contained in theguidance assembly. ln Figures 6a and 6b, another guidance assembly is illustrated. Figure6a shows the guidance assembly 40 in an unfolded state, ready for use, with sterile drapes41 extending from all sides. Figure 6b shows the same guidance assembly as in Figure 6a,but without showing the extending drapes 41, in order to more clearly show the contents. Theassembly may be packaged e.g. in a rectangular box measuring about 70 x 300 x 400mm. Atthe upper left quadrant of the box, sides may be made of a flexible material, while the bottom14is flexible, transparent and easy to puncture with a needle. Notably, "upper" herein is meantto be the direction of a patient's head, when the device is in use as described. The rest of thebottom and the sides of the box are preferably made of a semi-stiff absorbent material thatkeeps its form during transport.
Along at least the upper border of all sides, a sterile drape 41 may be attached. By unfoldingthe drape the sterile working area is enlarged. At the upper left quadrant or other suitableposition, a sleeve or probe cover that can accommodate an ultrasonography probe will beattached to the inner surface of the drape. Using such a sleeve ensures that a (non-sterile)ultrasound probe can be used without contaminating the sterile field of the assembly.
The guidance assembly 40 shown in Figure 6a and 6b further comprises a guidance device 1as described above, as well as an introducer and/or needle for puncture of the skin, a dilatorto widen the entry hole, an occlusion device as previously described and preferably two-prefilled syringes for inflating the balloons. All components are releasably attached to thebottom of the case to prevent displacement during transportation. Other accessories such asat least a pair of sterile gloves, sterile ultrasound gel and sterile wipes or sterile fluid can beprovided in the assembly.
Preferably, an introducer for use with the guidance device as described herein is providedwith a reinforced tip. Thus, it can be placed Without the need for incising the skin, eliminatingone or more steps in the procedure.
The present invention is not limited to the above-described preferred embodiments. Variousalternatives, modifications and equivalents may be used. Therefore, the above embodimentsshould not be taken as limiting the scope of the invention, which is defined by the appendingclaims.

权利要求:
Claims (1)
[1] A guidance device (1 ) for ultrasonographic guidance of percutaneous placement of an occlusion device in a subject, said guidance device (1) being adapted for placement against the body of the subject essentially at a desired percutaneous insertion site for said occlusion device, and wherein said guidance device (1) comprises a directing member (2) configured toreceive an introducer for percutaneous insertion of an occlusion device into a blood vesse| of a subject, wherein said directing member (2) is oriented such that said introducer received insaid directing member (2) provides for insertion of said occlusion device along a firstaxis (A), said guidance device (1) being adapted to receive and releasably hold anultrasonographic imaging probe (10) to obtain an image having an imaging plane (11) being a first plane, wherein said guidance device (1) is arranged to hold said ultrasonographic imagingprobe (10) such that said first axis (A) of said directing member (2) is positioned in a second plane (16) that is essentially perpendicular to said first plane (11), and said directing member (2) is coupled to said guidance device (1 ) via an attachmentmember (5) such that said directing member (2) is configured to be movable only in said second plane (16). A guidance device (1) according to claim 1, wherein said guidance device (1)comprises a cavity (4) arranged to hold said probe (10) such that the imaging plane(1 1) of said probe (10) is arranged essentially perpendicularly to the first axis (A) of the directing member (2). A guidance device (1) according to any previous claim, wherein an outer surface (3)being adapted for placement against the body of the subject is shaped to correspond to a general shape of a human or mammalian groin area. A guidance device (1) according to any previous claim, further comprising a support adapted to correspond to a general shape of a human or mammalian groin area. A guidance device (1) according to any previous claim, wherein said attachment member (5) is a hinge. 16 10. 11. 12. 13. A guidance device (1) according to any previous claim, further comprising attachmentmeans for attaching said guidance device (1) on said subject essentially at said desired percutaneous insertion site for said occlusion device. A guidance assembly (30, 40) for performing occlusion of a blood vessel, said guidance assembly comprising an occlusion device for occluding a blood vessel of a subject, an introducer for percutaneous insertion of said occlusion device into a blood vesselof a subject, an integrated guidance device (1 ) for ultrasonographic guidance according to any ofclaims 1-6, a container for enclosing and transporting components of said guidance assembly. A guidance assembly according to claim 7, wherein said occlusion device (20)comprises at least a first balloon (24) for inflation inside a blood vessel, and a second balloon (25), for inflation inside a blood vessel. A guidance assembly according to any of claim 7-8, wherein said occlusion devicefurther comprises a pressure sensor for measuring blood pressure at a distal end of said occlusion device. A guidance assembly according to any of claim 7-9, further comprising at least onesyringe preloaded with infusion fluid, said syringe adapted for connection to said occlusion device for inflation of at least a first balloon. A guidance assembly according to any of claim 7-10, further comprising sterile drapes adapted to define a sterile field within at least said container. A guidance assembly according to any of claim 7-11, further comprising attachmentmeans for attaching said container on said subject essentially at said desired percutaneous insertion site for said occlusion device. A method for performing occlusion of a blood vessel using a guidance device, comprising the steps of - attaching a guidance device (1) according to any of claims 1-6 to a subject at a percutaneous insertion site for insertion of an occlusion device, - inserting an ultrasonographic imaging probe (10) in said guidance device, 17 - puncturing said percutaneous insertion site to access an underlying bloodvessel under guidance of an image produced by said ultrasonographic imaging probe (10), - inserting an introducer through the directing member (2) of the guidancedevice (1) into said percutaneous insertion site and into said blood vesselunder guidance of an image produced by said ultrasonographic imaging probe, - inserting an occ|usion device through the directing member (2) of theguidance device (1) into said percutaneous insertion site and into a blood vesseL - lnflating at least one balloon such that a blood vessel is occluded at a desired site.
14. The method according to claim 13, wherein said guidance device (1) is comprised in a guidance assembly according to any one of claims 7-12. 18

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同族专利:

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公开号 | 公开日

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AU2016320316A1|2018-04-26|

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US20180263655A1|2018-09-20|

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SE541405C2|2019-09-24|

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WO2017042119A1|2017-03-16|

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EP3346924A1|2018-07-18|

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法律状态:
2021-10-12| NUG| Patent has lapsed|

优先权:

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申请号 | 申请日 | 专利标题

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SE1551145A|SE541405C2|2015-09-08|2015-09-08|Guidance device for ultrasonographic guidance of an occlusion device and a guidance assembly for performing occlusion of a blood vessel|SE1551145A| SE541405C2|2015-09-08|2015-09-08|Guidance device for ultrasonographic guidance of an occlusion device and a guidance assembly for performing occlusion of a blood vessel|

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US15/758,404| US20180263655A1|2015-09-08|2016-09-05|Guidance device for ultrasonography guided device placement|

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PCT/EP2016/070826| WO2017042119A1|2015-09-08|2016-09-05|Guidance device for ultrasonography guided device placement|

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EP16760709.2A| EP3346924A1|2015-09-08|2016-09-05|Guidance device for ultrasonography guided device placement|

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AU2016320316A| AU2016320316A1|2015-09-08|2016-09-05|Guidance device for ultrasonography guided device placement|