SE537098C2 - Device for modifying the shape of an endotracheal tube - Google Patents

Abstract

23 ABSTRACT The present invention disc1oses an endotrachea1 tube shape modulating device(1000) comprising a proXima1 casing (100), from Which a rigid ho11oW member (400) isextending in a forward cauda1 direction, a directing mechanism (600) attached at thedista1 end of the rigid ho11oW member (400) and an operating handle (200) extendingfrom the casing (100). The operating hand1e (200) is piVota11y connected to the casing(100) such that it may pivot around a operating hand1e pivot aXis (250) from a forwardposition in a sagittal re1aXed state to a backWard position in a sagittal compressed state.The operating hand1e (200) is mechanica11y connected to the directing mechanism (600)by means of an upper directing Wire (510), attached at its proXima1 end to an upperattachement point (210) of the operating hand1e (200) and at its dista1 end to a point onthe ventra1 side of the directing mechanism (600), and by means of a 1oWer directingWire (515), attached at its proXima1 end to a 1oWer attachment point (215) of theoperating hand1e (200) and at its dista1 end to a point on the dorsa1 side of the directingmechanism (600). The operating hand1e pivot aXis (250) is 1ocated dorsa11y re1ative theupper attachment point (210) and Ventra11y re1ative the 1oWer attachment point (215 ). To be pub1ished With Pig. 1

Description

ENDOTRACHEAL TUBE SHAPE MODULATING DEVICE TECHNICAL FIELDThe present invention relates to an endotracheal tube shape modulating devicefor user control of the orientation of the distal end of an associated endotracheal tube during intubation.

BACKGROUND Endotracheal tubes are used in a variety of medical situations to provide aconduit to a patient°s trachea. In situations when medical attention is needed, medicalpersonnel will determine if the patient”s airways are uncompromised and functional. Ifnot, an emergent life threatening situation arises whereby the medical personnel need tosecure a route of artificial ventilation, commonly by placement of an endotracheal tubethrough the mouth into the tracheobroncial tree. Such oraltracheal placement of anendotracheal tube is often found to be a difficult procedure, even for well trainedmedical personnel and particularly in stressful situations. This difficulty can partly beattributed to anatomic variations of the patient, and partly to the fact that an object, e. g.an endotracheal tube, inserted through the throat has to be guided into one of twopossible routes, the tracheal and the esophageal. It is not uncommon that esophagealintubation is unintentionally achieved instead of the intended tracheal intubation. Thecombination of a generally soft and pliable endotracheal tube, and the critical passagethrough the glottic opening, often results in great difficulties to perform a rapid andcorrect intubation even under optimal conditions. Instead of using tubes made of astiffer material, which is not acceptable due to the increased risk of causing trauma andswelling of the delicate surrounding tissue, removable stiffening devices placed on theoutside or inside of the tube are often used to maintain the desired contour of the tubeduring the intubation. Routinely, a laryngoscope is used to visualize the patient”s airwayduring intubation to allow the user to directly observe the passage of the tube andassociated stiffening device. Preferably, a stiffening device should allow for in-situchange of contour and orientation of the tube, in particular the front part of the tube, inorder to achieve a correct a rapid placement with minimal trauma to the surroundingtissue.

WO2007/ 138569 discloses an intubation stylet with a pivotally attached link atits distal end and an L- shaped lever with a downward dependin g handle at its proXimalend, for insertion into an endotracheal tube. Upon tautening a flexible wire byemployment of the handle, the link is flexed to form a hook-like configuration formanipulating an endotracheal tube”s outboard end. Disadvantages of this stylet include, for example, a sub-optimal lateral control of the tube°s end at all positions of the handle.

Due to the design of the proximal part of the stylet, user controlled lateral movement ofthe distal end is achieved by a rotating movement of the user”s hand and Wrist to rotatethe, relative the hand, downwards directed stylet, Which is cumbersome for the user.Additional disadvantages include the ability of the Wire to contact the inside of the tubealong the major part of the tubes length. This mechanic interaction, in particular duringrelative movement When the handle is manipulated, may cause damage to the inside ofthe tube and increase the risk of formation of loosening fragments from the same. Suchfragments are related to a serious health hazard for the patient.

WO97/26036 discloses a tool similar to the intubation stylet ofWO2007/ 138569, With exception for e. g. a control line, corresponding to the Wire ofWO2007/ 138569, being partly protected from contacting the endotracheal tube by beingextended inside a part of the tool. Disadvantages of this tool include, for example, thesame disadvantages as related to the stylet of WO2007/ 138569 regarding sub-optimallateral control of the tube”s end.

WO2008/030349 and WO2007/035297 disclose endotracheal intubationdevices comprising gripping means, control means and a tubular element With acurvable portion. The curvable portion may have one or more slits or may comprise aseries of asymmetric vertebra to provide flexibility. Means for transmitting user force,such as a Wire attached to the control means, is provided to curve the curvable portion ina controlled manner from a fully straight configuration to a curved configuration.Disadvantages of these devices include, for example, the dependency on the inherentability of the devices to accomplish a return from a curved to a less curvedconfiguration When correct placement of an associated endotracheal tube so requiresWhen being guided through various anatomical features by a user. Hence, such return ofthe devices is passive and not actively controllable by the user, i.e. user control of thedevices is sub-optimal.

WO20l 1/065963 discloses an endotracheal intubation device including astylet, an elongated rod mounted therein and adapted curve the stylet and anendotracheal tube mounted on the device. A handle mounted to the stylet is adapted toactuate the elongated rod to curve the stylet. In sirr1ilarity to disadvantages associatedWith the devices of WO2008/030349 and WO2007/035297, return of the devices from acurved configuration is passive and not actively controllable by the user, i.e. user control of the devices is sub-optimal Hence, an improved device for improved in-situ change of the shape and orientation of an endotracheal tube during intubation is desired.

SUMMARYIt is an object of the present invention, considering the disadvantagesmentioned above, to provide an endotracheal tube shape modulating device withimproved user control of the orientation of the distal end of an endotracheal tube duringintubation.

It is another object of the present invention to provide an endotracheal tubeshape modulating device with active user control of change of direction of the distal endof an endotracheal tube in both of the ventral and the dorsal direction.

It is yet another object of the present invention to provide an endotracheal tubeshape modulating device which is relatively insensitive to external violence and suitablefor pre-hospital applications, e. g. in ambulances and similar emergency vehicles.

These and other objects, which will appear from the following description,have now been achieved by an endotracheal tube shape modulating device which,according to one aspect of the present invention, comprises a proximal casing fromwhich a rigid hollow member is extending in a forward caudal direction, a directingmechanism attached at the distal end of the ri gid hollow member, and an operatin ghandle extending from the casing, wherein the endotracheal tube shape modulatingdevice has a sagittal relaxed state in which the projection of the directing mechanism ina sagittal plane is extending essentially along the longitudinal extension of the rigidhollow member in the same sagittal plane, and a sagittal compressed state in which theprojection of the distal end of the directing mechanism in a sagittal plane is locatedventrally relative the projection of the longitudinal extension of the rigid hollowmember in the same sagittal plane; wherein the operating handle being pivotallyconnected to the casing such that the operating handle may pivot around a operatinghandle pivot axis relative the casing from a forward position in the sagittal relaxed stateto a backward position in the sagittal compressed state, the distal end of the operatinghandle being closer to the proximal end of the casing in the backward position than inthe forward position; the operatin g handle being mechanically connected to thedirecting mechanism by means of an upper directing wire, attached at its proximal endto an upper attachment point of the operatin g handle and at its distal end to a point onthe ventral side of the directing mechanism, and a lower directing wire, attached at itsproximal end to a lower attachment point of the operating handle and at its distal end toa point on the dorsal side of the directing mechanism, the operating handle pivot axisbeing located dorsally relative the upper attachment point and ventrally relative thelower attachment point; and the upper directing wire and the lower directing wireextending inside the rigid hollow member from the distal end of the casing through asingularity or plurality of passages selected from the group consisting of upper externalpassage, lower external passage and internal passage, the passages being located withinthe distal half of the rigid hollow member.

Advantages of such an endotracheal tube shape modulating device include, forexample, an active user control of the return of the device from a sagittal compressedstate to a sagittal relaxed state by actively pressing the operating handle forward. Inaddition, the Wires communicating force between the operating handle and the directin gmechanism are extending mainly on the inside of the rigid holloW member. Hence, theWires are hindered from scuffin g the inside of a mounted endotracheal tube, Which isadvantageous from a safety perspective.

According to another aspect of the present invention, the endotracheal tubeshape modulating device may comprise a left operating lever pivotally connected to thecasing and arranged to pivot in a sagittal plane around a left operating lever pivot axis,and a right operating lever pivotally connected to the casing and arranged to pivot in asagittal plane around a right operating lever pivot axis, Wherein the left operating leverbeing mechanically connected to the directing mechanism by means of a left directin gWire, attached at its proximal end to a left operating lever Wire attachment point of theleft operating lever and at its distal end to a point on the left side of the directingmechanism; the right operating lever being mechanically connected to the directingmechanism by means of a right directin g Wire, attached at its proximal end to a rightoperating lever Wire attachment point of the right operating lever and at its distal end toa point on the right side of the directin g mechanism; the left operating lever pivot axisand the right operating lever pivot axis being located ventrally relative the left operatinglever Wire attachment point and the right operating lever Wire attachment point,respectively; the left directing Wire and the right directing Wire extending inside therigid holloW member from the distal end of the casing through a sin gularity or pluralityof passages selected from the group consisting of left extemal passage, right extemalpassage and intemal passage, the passages being located Within the distal half of therigid holloW member; and the endotracheal tube shape modulating device has a coronalrelaxed state in Which the projection of the directing mechanism in a coronal plane isextending essentially along the projection of the longitudinal extension of the rigidholloW member in the same coronal plane, and a coronal compressed state in Which theprojection of the distal end of the directing mechanism in a coronal plane is locatedlaterally relative the projection of the longitudinal extension of the rigid holloW memberin the same coronal plane.

Advantages of such an endotracheal tube shape modulating device include, forexample, user control of the movement of the directing mechanism in both lateraldirections, i.e. left and right, Which may facilitate and reduce the time needed to install athereon mounted endotracheal tube.

According to yet another aspect of the present invention, there is provided anendotracheal tube shape modulating device comprising a tube holder arranged to disengageably lock an endotracheal tube in relation to the rigid holloW member for prevention of relative movement of the endotracheal tube in relation to the hollow member in a proXimal or distal direction.

Further features of the invention and its embodiments are set forth in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS These and other aspects, features and advantages of which the invention iscapable will be apparent and elucidated from the following description of non-limitingembodiments of the present invention, reference being made to the accompanyingdrawings, in which Fig. l is a perspective view of an endotracheal tube shape modulating device1000 in a coronal and sagittal relaXed state with a directing mechanism 600 comprisinga first directing element 6l0 being pivotally movable in a coronal plane and a seconddirecting element 620 being pivotally movable in a sagittal plane and a distal directingelement 630 being pivotally movable in a sagittal plane, a rigid hollow member 400, acasing l00 from which an operating handle 200, a left operating lever 300 and a rightoperating lever 350 is eXtending and a spring element 700 for resiliently biasing theoperating handle 200 toward a distal direction, according to an embodiment of thepresent invention; Fig. 2 is a perspective view of an endotracheal tube shape modulating devicel000 in a coronal relaXed and sagittal partly compressed state with a directingmechanism 600 comprising a first directing element 6l0 being pivotally movable in acoronal plane, around an axis Cl eXtending in a coronal plane, and in a sagittal plane,around an aXis Sl extending in a sagittal plane, and a distal directing element 630 beingpivotally movable in a sagittal plane, around an aXis C2 extending in a coronal plane,and with a rigid hollow member 400 comprising a left eXtemal passage 4l0 from whicha left directing wire 520 is eXtending to a fastening point at the left side of the firstdirecting element 6l0 and a upper external passage 420 from which an upper directingwire is eXtending to a fastening point at the ventral side of the distal directing element630, according to an embodiment of the present invention; Fig. 3 is a perspective view of an endotracheal tube shape modulating devicel000 in a coronal relaXed and sagittal compressed state with a directing mechanism 600comprising a first directing element 6l0 being pivotally movable in a sagittal plane anda distal directing element 630 being pivotally movable in a sagittal plane, and with arigid hollow member 400 and an operating handle 200, according to an embodiment ofthe present invention; Fig. 4 is a cut-through view of a casing l00 from the left side showing operating handle 200 comprising an upper attachment point 2l0, from which upper directing wire 510 is eXtending in a distal direction, a lower attachment point 215, fromwhich lower directing wire 515 is eXtending in a distal direction, and operating handlepivot aXis 250, around which the operating handle 200 may pivot in a sagittal plane, aleft operating lever 300 comprising a left operatin g lever wire attachment point 320,from which left directing wire 520 is eXtending in a distal direction, and left operatinglever pivot aXis 310, around which left operating lever 300 may pivot in a sagittal plane,according to an embodiment of the present invention; Figs. 5A and 5B are perspective views of the proXimal part of an endotrachealtube shape modulating device 1000, in a coronal relaXed and sagittal partly compressedstate, comprising operating handle 200 with its operating handle pivot aXis 250, upperattachment point 210 of upper directing wire 510, lower attachment point 215 of lowerdirecting wire 515, left operating lever 300 with its left operating lever pivot aXis 310,left operating lever wire attachment point 320 of left directing wire 520, right operatinglever 350 with its right operating lever pivot aXis 360, right operating lever wireattachment point 375 of right directing wire 525 and spring element 700 forcingoperating handle 200 in a forward distal direction unless hindered by e. g. a user,according to an embodiment of the invention; Fig. 6 is a perspective view of the endotracheal tube shape modulating device1000 of Figs. 5A and 5B in a sagittal fully compressed state, wherein operating handle200 is pressed maXimally backwards in the proximal direction, and in a compressedcoronal state, wherein left operating handle 300 is pressed forward in a distal direction,according to an embodiment of the invention; Figs. 7A and 7B are eXploded views from the left side (A) and from the upperventral side (B) of the directing mechanism 600 of the endotracheal tube shapemodulating device 1000 of Fig. 2, comprising a lateral rigid hollow member bore 403that coincides with a ventral two aXis joint first bore 604 of a two aXis joint 603 to allowmounting of connecting pins 650 to enable a pivoting movement of the two aXis joint603 relative rigid hollow member 400, a first directing element 610 with a first directingelement proXimal bore 614 eXtending in a sagittal plane that coincides with a two aXisjoint second bore 605 to allow mounting of connecting pin 650 to enable a pivotingmovement of the first directing element 610 relative the two aXis joint 603, and a distaldirecting element 630 with a lateral distal directing element proXimal bore 635 thatcoincides with a lateral first directing element distal bore 615 to allow mounting of pin650 to enable pivoting movement of the distal directing element 630 relative the firstdirecting element 610, according to an embodiment of the invention; Fig. 8 is a perspective partly eXploded view of the directing mechanism 600 ofthe endotracheal tube shape modulating device 1000 of Fig. 1, comprising a ventral-dorsal rigid hollow member bore 403 that coincides with a first directing element proXimal bore 614 (not shown) of a first directing element 610 to enable a pivoting movement of the first directing element 610 relative the ri gid hollow member 400, asecond directing element 620 with a lateral second directing element proXimal bore 624that coincides with a first directing element distal bore 615 to enable a pivotingmovement of the second directing element 620 relative the first directing element 610, adistal directing element 630 with a lateral distal directin g element proXimal bore 635that coincides with a lateral second directing element distal bore 625 to enable apivoting movement of the distal directing element 630 relative the second directingelement 620, a left directing wire 520 attached at its distal end to the left side of the firstdirecting element 610 and eXtending in a proXimal direction through an intemal passage430 further within the ri gid hollow member 400, and an upper directin g wire 510attached at its distal end to the ventral side of the distal directing element 630, accordingto an embodiment of the invention; Figs. 9A and 9B are perspective views of the directing mechanism 600 of theendotracheal tube shape modulating device 1000 of Fig. 1 showing an aXis S1 eXtendingin a ventral-dorsal direction around which aXis the first directing element 610 ispivotally movable, an aXis Cl eXtending in a lateral direction around which aXis thesecond directing element 620 is pivotally movable, and an aXis C2 eXtending in a lateraldirection around which aXis the distal directing element 630 is pivotally movable,according to an embodiment of the invention; Figs. 10A, 10B and l0C are perspective views of the directing mechanism 600of the endotracheal tube shape modulating device 1000 of Fig. 1 in a coronal andsagittal relaXed state, acoording to an embodiment of the invention; Figs. 11A, 11B and l1C are eXploded perspective views of the directingmechanism 600 of an endotracheal tube shape modulating device 1000 in which a firstdirecting element 610 is pivotally movable around a lateral axis defined by a rigidhollow member bore 403 and a first directing element proximal bore 614, and a distaldirecting element 630 is pivotally movable around a lateral aXis defined by a firstdirecting element distal bore 615 and a distal directing element proXimal bore 635,according to an embodiment of the invention; Figs. 12A and 12B are perspective views of a mounted directing mechanism600 of Figs. 11A, 11B and l1C in a sagittal compressed state, showing upper directingwire 510 attached at its distal end to the ventral side of distal directing element 630 andentering through an upper external passage 420 at the ventral side of rigid hollowmember 400, according to an embodiment of the invention; Fig. 13 is a perspective view of the directing mechanism 600 of Figs. 12A and12B, showing a lower directing wire 515 attached at its distal end to the dorsal side ofdistal directing element 630 and entering through a lower eXtemal passage 425 at thedorsal side of rigid hollow member 400, according to an embodiment of the invention; and Fig. 14 is a perspective view of the endotracheal tube shape modulating device1000 of Fig. 2, showing its relation to the ventral, dorsal, lateral, proximal or cranial anddistal or caudal directions, and to the sagittal, coronal and transverse planes, forillustrative purposes in order for the skilled person to clearly understand what may be understood by such directions and planes herein, according to one embodiment.

DETAILED DESCRIPTION OF THE EMBODIMENTS Embodiments of the present invention will be described in more detail belowwith reference to the accompanyin g drawings in order for those skilled in the art to beable to carry out the invention. The invention may, however, be embodied in manydifferent forms and should not be construed as limited to the embodiments set forthherein. Rather, these embodiments are provided so that this disclosure will be thoroughand complete, and will fully convey the scope of the invention to those skilled in the art.The embodiments do not limit the invention, but the invention is only limited by theappended patent claims. Furthermore, the terminology used in the detailed descriptionof the particular embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention.

Embodiments of the present invention will now be described below withreference to Figs. l to l4. Reference to various parts of the drawings are done by numbers according to the table below. # part or parts 1000 endotracheal tube shape modulating device100 casing 110 palm support surface 200 operating handle 210 upper attachment point 215 lower attachment point 250 operating handle pivot axis 300 left operating lever 310 left operating lever pivot axis 320 left operating lever wire attachement point350 right operating lever 360 right operating lever pivot axis 375 right operating lever wire attachement point400 rigid hollow member 403 rigid hollow member bore 410 left external passage 415 right external passage 420 upper external passage 425 lower external passage 430 internal passage 510 upper directing wire 515 lower directing wire 520 left directing wire 525 right directing wire 600 directing mechanism 606 two axis joint 604 two axis joint first bore 605 two axis joint second bore 610 first directing element 614 first directing element proximal bore615 first directing element distal bore 620 second directing element 624 second directing element proximal bore625 second directing element distal bore660 distal directing element 665 distal directing element proximal bore650 connecting pin 700 spring element The present endotracheal tube shape modulating device 1000 essentiallycomprise a proximal casing 100, a distal directing mechanism 600, a rigid holloWmember 400 and means for communicating user eXerted force from at least onepivotally movable handle or lever extending from the casing 100 to the directingmechanism 600. Such handles or levers may include an operating handle 200, a leftoperating lever 300 and a right operatin g lever 350. Means for communicating userexerted force include, for example, Wires connected at one end to the part of handles orlevers Which is arranged Within the casing 100, and at the other end to the outer surfaceof the distal directing mechanism 600. Preferably, at least a part of each of the Wires isextending Within the inside of the rigid holloW member 400. Examples of such Wiresinclude an upper directin g Wire 510, a lower directing Wire 515, a left directing Wire 520and a right directing Wire 525. A fleXible endotracheal tube, such as e. g. a standardplastic endotracheal tube, may be mounted to partly or fully cover the distal directingmechanism 600 and the rigid holloW member 400. The shape of the rigid holloWmember 400 may be such that it mimics the natural endotracheal pathWay from themouth to the tracheobroncial tree, such as e. g. slightly curved upWards in a ventraldirection. This shape is translated to the endotracheal tube, in particular When the outerdiameter of the distal directing mechanism 600 and the rigid holloW member 400 isequal to or slightly smaller than the inner diameter of the endotracheal tube, such as e. g.30 to 100% or 50 to 90% thereof. In order to change the direction and/or shape of, mostimportantly for a facile introduction, the distal part of the endotracheal tube, the distal directing mechanism 600 may be additionally curved upWards, i.e. in a ventral direction, by user controlled pulling of operating handle 200. Return of the operatinghandle 200 to a forward position may be accomplished by a resilient retumingmechanism, such as e. g. spring element 700 or any other similar returning mechanismas well known in the art. The casing l00 may be designed, as known in the art, to allowa user to operate the present endotracheal tube shape modulating device l000 with onehand only. For example, a user may rest the palm of one hand on a palm support surfacell0 while simultaneously pulling operating handle 200 with one or several fingers withexception of the thumb, to curve the distal directing mechanism 600 upwards, i.e. in aventral direction. The operatin g handle 200 may be further designed to allow a user topush it forward in a distal direction by use of e. g. the index finger, to aid the dorsalretum of the distal directing mechanism 600. For example, the operating handle 200may comprise a ring shaped element in which the index finger may be placed. Whileresting the palm of one hand on the palm support surface ll0 and gently grabbingaround the operating handle 200 with one or several fingers, the user”s thumb may beused to push forward one of a left operating lever 300 and a right operating lever 350 toaccomplish a left lateral and a right lateral movement, respectively, of the directingmechanism 600. The distal directing mechanism 600 may comprise at least two separatedirecting elements that are pivotally connected to each other and to the distal end of therigid hollow member 400, to allow at least a ventral-dorsal movement of the directingmechanism 600 and optionally a lateral movement of the same.

According to one embodiment, the endotracheal tube shape modulating devicel000 may comprise a proximal casing l00 from which a rigid hollow member 400 isextending in a forward caudal direction, a directing mechanism 600 attached at thedistal end of the rigid hollow member 400 and an operating handle 200 extending fromthe casing l00. The endotracheal tube shape modulating device l000 may have asagittal relaxed state in which the projection of the directing mechanism 600 in asagittal plane is extending essentially along the longitudinal extension of the rigidhollow member 400 in the same sagittal plane. The endotracheal tube shape modulatingdevice l000 may further have a sagittal compressed state in which the projection of thedistal end of the directing mechanism 600 in a sagittal plane is located ventrally relativethe projection of the longitudinal extension of the rigid hollow member 400 in the samesagittal plane. An infinite number of sagittal compressed states exist in between thesagittal relaxed state and a sagittal maximally compressed state, the latter whichrepresent a state in which the directing mechanism 600 is maximally turned upwards ina ventral direction. The operating handle 200 may be pivotally connected to the casingl00 such that the operating handle 200 may pivot around an operating handle pivot axis250 relative the casing l00, from a forward position in the sagittal relaxed state to abackward position in the sagittal compressed state. The distal end of the operatinghandle 200 may be closer to the proximal end of the casing l00 in the backward ll position than in the forward position. The operating handle 200 may be mechanicallyconnected to the directing mechanism 600 by means of an upper directing wire 5 10. Theupper directing wire 5 10 may be attached at its proximal end to an upper attachementpoint 2l0 of the operating handle 200 and at its distal end to a point on the ventral sideof the directing mechanism 600. The operating handle 200 may be mechanicallyconnected to the directing mechanism 600 by means of a lower directing wire 5 l5,attached at its proximal end to a lower attachment point 2l5 of the operating handle 200and at its distal end to a point on the dorsal side of the directing mechanism 600. Theoperating handle pivot axis 250 may be located dorsally relative the upper attachmentpoint 2l0 and ventrally relative the lower attachment point 2l5. The upper directingwire 5 l0 and the lower directing wire 5 l5 may extend inside the rigid hollow member400 from the distal end of the casing l00 through a singularity or plurality of passagesselected from the group consisting of upper external passage 420, lower extemalpassage 425 and internal passage 430. The passages may preferably be located withinthe distal half of the rigid hollow member 400, more preferable within the distal third orquarter of the same.

According to another embodiment, the endotracheal tube shape modulatingdevice l000 may comprise a left operating lever 300 pivotally connected to the casingl00 and arranged to pivot in a sagittal plane around a left operating lever pivot axis 3l0,and a right operating lever 350, pivotally connected to the casing l00 and arranged topivot in a sagittal plane around a right operating lever pivot axis 360. The left operatinglever 300 may be mechanically connected to the directing mechanism 600 by means ofa left directing wire 520 attached at its proximal end to a left operating lever wireattachment point 320 of the left operating lever 300 and at its distal end to a point on theleft side of the directing mechanism 600. The right operating lever 350 may bemechanically connected to the directing mechanism 600 by means of a right directingwire 525, attached at its proximal end to a right operating lever wire attachment point375 of the right operating lever 350 and at its distal end to a point on the right side ofthe directing mechanism 600. The left operating lever pivot axis 3 l0 and the rightoperating lever pivot axis 360 may be located ventrally relative the left operating leverwire attachment point 320 and the right operating lever wire attachment point 375,respectively. The left directing wire 520 and the right directing wire 525 may extendinside the rigid hollow member 400 from the distal end of the casing l00 through asingularity or plurality of passages selected from the group consisting of left externalpassage 4l0, right external passage 4l5 and an intemal passage 430. The passages maypreferably be located within the distal half of the rigid hollow member 400, morepreferable within the distal third or quarter of the same. The endotracheal tube shapemodulating device l000 may have a coronal relaxed state in which the projection of the directing mechanism 600 in a coronal plane is extending essentially along the projection 12 of the longitudinal extension of the rigid hollow member 400 in the same coronal plane.The endotracheal tube shape modulating device 1000 may further have a coronalcompressed state in which the projection of the distal end of the directing mechanism600 in a coronal plane is located laterally relative the projection of the longitudinalextension of the rigid hollow member 400 in the same coronal plane. An infinitenumber of coronal compressed states exist in between the coronal relaxed state and aleft coronal maximally compressed state, the latter which represent a state in which thedirecting mechanism 600 is maximally turned toward the left side. Further, an infinitenumber of coronal compressed states exist in between the coronal relaxed state and aright coronal maximally compres sed state, the latter which represent a state in which thedirecting mechanism 600 is maximally turned toward the right side.

According to yet another embodiment, the directing mechanism 600 maycomprise a first directin g element 6l0, a distal directing element 630, an upper directingwire 5 l0 and a lower directing wire 5 l5. The first directing element 6l0 may beconnected to the distal end of the rigid hollow member 400 with a link, as known in theart, which enables a pivoting movement of it around a lateral pivot axis. The distaldirecting element 6l0 may be connected to the distal end of the first directing element6l0 with a link, as known in the art, which enables a pivoting movement of it around alateral pivot axis. The distal end of the upper directing wire 5 l0 may be connected tothe ventral side of the distal directing element 630. The distal end of the lower directingwire 5 l5 may be connected to the dorsal side of the distal directing element 630. Thearrangement according to this embodiment enables active user control of the movementof the directing mechanism 600 in a ventral direction and in a dorsal direction.

According to yet another embodiment, the directing mechanism 600 maycomprise a first directing element 6l0, a two axis joint 603 with two perpendicularconnectable pivoting axis, a distal directing element 630, an upper directing wire 5 l0, alower directing wire 5 l5, a left directing wire 520 and a right directing wire 525. One ofthe two perpendicular connectable pivoting axis of the two axis joint 603 may beconnected to the distal end of the rigid hollow member 400 with a link, as known in theart, which enables a pivoting movement of it around a lateral or ventral-dorsal pivotaxis. The first directing element may be connected to the other of the two perpendicularconnectable pivoting axis of the two axis joint 603 with a link, as known in the art,which enables a pivoting movement of it around a lateral or ventral-dorsal pivot axis.The distal directing element 6l0 may be connected to the distal end of the first directin gelement 6l0 with a link, as known in the art, which enables a pivoting movement of itaround a lateral pivot axis. The distal end of the upper directing wire 5 l0 may beconnected to the ventral side of the distal directing element 630. The distal end of thelower directing wire 5 l5 may be connected to the dorsal side of the distal directingelement 630. The distal end of the left directing wire 520 may be connected to the left 13 side of the distal directing element 630 or the first directing element 610. The distal endof the right directing wire 525 may be connected to the right side of the distal directingelement 630 or the first directing element 6l0. The arrangement according to thisembodiment enables active user control of the movement of the directing mechanism600 in a ventral direction, in a dorsal direction, in a left lateral direction and in a rightlateral direction.

According to yet another embodiment, the directing mechanism 600 maycomprise a two aXis joint 603 with two perpendicular connectable pivoting aXis, a distaldirecting element 630, an upper directing wire 5 l0, a lower directing wire 5 l5, a leftdirecting wire 520 and a right directing wire 525. One of the two perpendicularconnectable pivoting aXis of the two aXis joint 603 may be connected to the distal end ofthe rigid hollow member 400 with a link, as known in the art, which enables a pivotingmovement of it around a lateral or ventral-dorsal pivot aXis. The distal directing element630 may be connected to the other of the two perpendicular connectable pivoting aXis ofthe two aXis joint 603 with a link, as known in the art, which enables a pivotingmovement of it around a lateral or ventral-dorsal pivot aXis. The distal end of the upperdirecting wire 5 l0 may be connected to the ventral side of the distal directing element630. The distal end of the lower directing wire 515 may be connected to the dorsal sideof the distal directing element 630. The distal end of the left directing wire 520 may beconnected to the left side of the distal directing element 630. The distal end of the rightdirecting wire 525 may be connected to the right side of the distal directing element630. The arrangement according to this embodiment enables active user control of themovement of the directing mechanism 600 in a ventral direction, in a dorsal direction,in a left lateral direction and in a right lateral direction.

According to yet another embodiment, the directing mechanism 600 maycomprise a first directing element 6l0, a two aXis joint 603 with two perpendicularconnectable pivoting aXis, a distal directing element 630, an upper directing wire 5 l0, alower directing wire 5 l5, a left directing wire 520 and a right directing wire 525. Thefirst directing element 6l0 may be connected to the distal end of the rigid hollowmember 400 with a link, as known in the art, which enables a pivoting movement of itaround a lateral pivot aXis. One of the two perpendicular connectable pivoting axis ofthe two aXis joint 603 may be connected to the distal end of the first directing element6l0 with a link, as known in the art, which enables a pivoting movement of it around alateral or ventral-dorsal pivot aXis. The distal directing element 630 may be connectedto the other of the two perpendicular connectable pivoting aXis of the two aXis joint 603with a link, as known in the art, which enables a pivoting movement of it around alateral or ventral-dorsal pivot aXis. The distal end of the upper directing wire 5 l0 maybe connected to the ventral side of the distal directing element 630. The distal end of the lower directing wire 5 l5 may be connected to the dorsal side of the distal directing 14 element 630. The distal end of the left directing wire 520 may be connected to the leftside of the distal directing element 630. The distal end of the right directing wire 525may be connected to the right side of the distal directing element 630. The arrangementaccording to this embodiment enables active user control of the movement of thedirecting mechanism 600 in a ventral direction, in a dorsal direction, in a left lateraldirection and in a right lateral direction.

According to yet another embodiment, the directing mechanism 600 maycomprise a first directing element 6l0, two two aXis joints 603, each with twoperpendicular connectable pivoting aXis, a distal directing element 630, an upperdirecting wire 5 l0, a lower directing wire 5 l5, a left directing wire 520 and a rightdirecting wire 525. The two two aXis joints 603 may be arranged so that one of them issimultaneously pivotally connecting the distal end of rigid hollow member 400 and theproximal end of the first directing element 6l0, and the other the distal end of the firstdirecting element 6l0 and the proXimal end of the distal directing element 630. Thedistal end of the upper directing wire 5 l0 may be connected to the ventral side of thedistal directing element 630. The distal end of the lower directing wire 5 l5 may beconnected to the dorsal side of the distal directing element 630. The distal end of the leftdirecting wire 520 may be connected to the left side of the distal directing element 630.The distal end of the right directing wire 525 may be connected to the right side of thedistal directing element 630. The arrangement according to this embodiment enablesactive user control of the movement of the directing mechanism 600 in a ventraldirection, in a dorsal direction, in a left lateral direction and in a right lateral direction.

According to yet another embodiment, the directing mechanism 600 maycomprise a first directin g element 6l0, having a first directing element proximal bore6l4 and a first directing element distal bore 6l5, a second directing element 620, havinga second directing element proximal bore 624 and a second directin g element distal bore625, and a distal directing element 630, having a distal directing element proXimal bore635. The first directing element 6l0 may be pivotally connected to the rigid hollowmember 400 by a singularity or plurality of connecting pins 650, such as one connectingpin 65 0, which together are eXtending through the first directing element proXimal bore6l4 and the ri gid hollow member bore 403 in a direction eXtending essentially from theventral side to the dorsal side of the endotracheal tube shape modulating device l000.The second directin g element 620 may be pivotally connected to the first directin gelement 6l0 by a singularity or plurality of connecting pins 650, such as one connectingpin 65 0, which together are eXtending through the second directing element proXimalbore 624 and the first directing element distal bore 6l5 in an essentially lateral directionof the endotracheal tube shape modulating device l000. The distal directing element630 may be pivotally connected to the second directing element 620 by a singularity or plurality of connecting pins 650, such as one connecting pin 650, which together are eXtending through the distal directing element proXimal bore 635 and the seconddirecting element distal bore 625 in an essentially lateral direction of the endotrachealtube shape modulating device 1000. The distal end of each of the left directing wire 520and the right directing wire 525 may be connected to the left and right side,respectively, of either of the first directing element 6l0, the second directing element620 and the distal directing element 630. The distal end of each of the upper directingwire 5 l0 and the lower directing wire 5 l5 may be connected to the ventral and dorsalside, respectively, of the distal directing element 630. The arrangement according to thisembodiment enables active user control of the movement of the directing mechanism600 in a ventral direction, in a dorsal direction, in a left lateral direction and in a rightlateral direction.

According to yet another embodiment, the endotracheal tube shape modulatingdevice l000 may comprise a tube holder arranged to disengageably lock anendotracheal tube in relation to the rigid hollow member 400 for prevention of relativemovement of the endotracheal tube in relation to the hollow member 400 in a proXimalor distal direction. Devices known in the art for disengagably fasten an outer hollowtubular element to a closed in inner element are well known in the art and may, afteroptional well known appropriate modifications, be used as such a tube holder. Forexample, such a tube holder may be a screw being screwed through the wall of theendotracheal tube which, in a screwed-in state, engages with the outer surface of therigid hollow member 400 and which , in a screwed-out state, disengages from the outersurface of the rigid hollow member 400. Advantages of a tube holder include, forexample, a minimized risk of unintentional relative movement between the endotrachealtube and the endotracheal tube shape modulating device l000. Such an unintentionalmovement may ag gravate the correct placement of the tube when the endotracheal tubeshape modulating device l000-endotracheal tube unit is pushed forward into the patient.The tube holder may typically be disengaged when the tube has been correctly placed toallow removal of the endotracheal tube shape modulating device l000 by a backwardmovement of the same with one hand, while holding the tube with the other hand.

According to yet another embodiment, the directing mechanism 600 maycomprise a first directin g element 6l0, having a first directing element proximal bore6l4 and a first directing element distal bore 6l5 which may eXtend essentially in lateraldirection, a distal directing element 630, having a distal directing element proXimal bore635 which may eXtend essentially in lateral direction, and a two aXis joint 603. The twoaXis joint 603 may be pivotally connected to the rigid hollow member 400 by asingularity or plurality of connecting pins 650, such as one connecting pin 650, whichtogether are eXtending through a two aXis joint first bore 604 and a rigid hollow memberbore 403. The two aXis joint first bore 604 may be essentially eXtending in a direction of either a ventral-dorsal direction and a lateral direction. The first directin g element 6l0 16 may be pivotally connected to the two aXis joint 603 by a Singularity or plurality ofconnecting pins 650, such as one connecting pin 650, which together are eXtendingthrough the first directin g element proXimal bore 6 14 and a two aXis joint second bore605. The two aXis joint second bore 605 may be eXtending in a direction essentiallyperpendicular to the direction of the two aXis joint first bore 604. The distal directingelement 630 may be pivotally connected to the first directing element 6l0 by asingularity or plurality of connecting pins 650, such as one connecting pin 650, whichtogether are extending through the distal directing element proXimal bore 635 and thefirst directing element distal bore 6l5. The distal end of each of the left directing wire520 and the right directin g wire 525 may be connected to the left and right side,respectively, of either of the first directin g element 6l0 and the distal directing element630. The distal end of each of the upper directing wire 5 l0 and the lower directing wire5 l5 may be connected to the ventral and dorsal side, respectively, of the distal directingelement 630. The arrangement according to this embodiment enables active user controlof the movement of the directing mechanism 600 in a ventral direction, in a dorsaldirection, in a left lateral direction and in a right lateral direction.

According to yet another embodiment, the endotracheal tube shape modulatingdevice l000 may comprise a suction device for removal of e. g. mucus or blood from theairways. Such a suction device may, for example, comprise a separate tube attached tothe outer surface of the rigid hollow member 400. The distal opening of such tube maybe arranged close to the distal end of an endotracheal tube when mounted on theendotracheal tube shape modulating device l000, and the proXimal opening connectedto a suitable pump outside the patient for removal of internal fluids, like e. g. mucus orblood. Optionally, the rigid hollow member 400 may serve as a conduit for such fluids.For example, a suitable pump may be connected near the proXimal end thereof via aseparate opening, while proXimal openings, such as e. g. one or several of the passages4l0, 4l5, 420, 425 and 430, may serve as inlet for such fluids.

According to yet another embodiment, the endotracheal tube shape modulatingdevice l000 may comprise means for detection of a correct placement of theendotracheal tube in the tracheobroncial tree. Such means, such as e. g. carbon dioXidedetectors and oXygen detectors, are known in the art.

According to yet another embodiment, the rigid hollow member 400 may bemade of a material, as known in the art, which is essentially impossible to bend.Examples of such materials include, but is not lin1ited to, metals like e. g. aluminum andstainless steel and suitable plastic or polymeric materials.

According to yet another embodiment, the rigid hollow member 400 may bemade of a material, as known in the art, which makes it slightly bendable in a non- resilient fashion. Such a slightly bendable rigid hollow member 400 will 17 advantageously allow a user to pre-form the same according to the patient”s personalanatomy for a more facile placement of the endotracheal tube.

According to yet another embodiment, the endotracheal tube shape modulatingdevice 1000 may be designed and used for nasal placement of an endotracheal tube.

According to yet another embodiment, the endotracheal tube shape modulatingdevice l000 may comprise a removable cover or case. Such a removable cover or casemay, for example, be made of a flexible material such as e. g. latex or a medicallyacceptable plastic or polymeric material. Preferable, the cover or case is design totightly fit and cover at least the entire distal part of the endotracheal tube shapemodulating device l000, Which is Within the patient during use of the same. Such acover or case Will advantageously minimize the risk of exposing the patient to infectiousmicroorganisms residing on an incompletely sterilized endotracheal tube shape modulating device l000.

In the claims, the term “comprises/comprising” does not exclude the presenceof other elements or steps. Furthermore, although individually listed, a plurality ofmeans, elements or method steps may be implemented by e. g. a single unit or processor.Additionally, although individual features may be included in different claims, thesemay possibly advantageously be combined, and the inclusion in different claims doesnot imply that a combination of features is not feasible and/or advantageous. Inaddition, singular references do not exclude a plurality. The terms “a”, “an”, “first”,“second” etc do not preclude a plurality. Reference signs in the claims are providedmerely as a clarifying example and shall not be construed as limiting the scope of the claims in any Way.

Claims (10)

1. l. An endotracheal tube shape modulating device (1000) comprising a proximal casing(100) from which a rigid hollow member (400) is extending in a forward caudaldirection, a directing mechanism (600) attached at the distal end of said rigid hollowmember (400), and an operating handle (200) extending from said casing (l00), whereinsaid endotracheal tube shape modulating device (l000) has a sagittal relaxed state inwhich the projection of said directing mechanism (600) in a sagittal plane is extendingessentially along the longitudinal extension of said rigid hollow member (400) in thesame sagittal plane, and a sagittal compressed state in which the projection of the distalend of said directing mechanism (600) in a sagittal plane is located ventrally relative theprojection of the longitudinal extension of said rigid hollow member (400) in the samesagittal plane; wherein said operating handle (200) being pivotally connected to said casing (l00) such that saidoperating handle (200) may pivot around a operating handle pivot axis (250) relativesaid casing (l00) from a forward position in said sagittal relaxed state to a backwardposition in said sagittal compressed state, the distal end of said operating handle (200)being closer to the proximal end of said casing (l00) in said backward position than insaid forward position; said operating handle (200) being mechanically connected to said directing mechanism(600) by means of an upper directing wire (5 l0), attached at its proximal end to anupper attachement point (2l0) of said operating handle (200) and at its distal end to apoint on the ventral side of said directing mechanism (600), and a lower directing wire(5 l5), attached at its proximal end to a lower attachment point (2l5) of said operatinghandle (200) and at its distal end to a point on the dorsal side of said directingmechanism (600), said operating handle pivot axis (250) being located dorsally relativesaid upper attachment point (2l0) and ventrally relative said lower attachment point(2l5); and said upper directing wire (5 l0) and said lower directing wire (5 l5) extending inside saidrigid hollow member (400) from the distal end of said casing (l00) through a singularityor plurality of passages selected from the group consisting of upper extemal passage(420), lower external passage (425) and intemal passage (430), said passages beinglocated within the distal half of said rigid hollow member (400). 19

2. Endotracheal tube shape modulating device (1000) according to claim l, furthercomprising a left operating lever (300) pivotally connected to said casing (100) andarranged to pivot in a sagittal plane around a left operating lever pivot axis (3l0), and aright operating lever (35 0) pivotally connected to said casing (l00) and arranged topivot in a sagittal plane around a right operating lever pivot axis (360), Wherein said left operating lever (300) being mechanically connected to said directingmechanism (600) by means of a left directing Wire (520), attached at its proximal end toa left operating lever Wire attachment point (320) of said left operating lever (300) andat its distal end to a point on the left side of said directing mechanism (600); said right operating lever (350) being mechanically connected to said directingmechanism (600) by means of a right directing Wire (525), attached at its proximal endto a right operating lever Wire attachment point (375) of said right operating lever (350)and at its distal end to a point on the right side of said directing mechanism (600); said left operating lever pivot axis (3l0) and said right operating lever pivot axis (360)being located ventrally relative said left operatin g lever Wire attachment point (320) andsaid right operating lever Wire attachment point (375), respectively; said left directing Wire (520) and said right directing Wire (525) extending inside saidrigid holloW member (400) from the distal end of said casing (l00) through a singularityor plurality of passages selected from the group consisting of left external passage(4l0), right extemal passage (4l5) and internal passage (430), said passages beinglocated Within the distal half of said rigid holloW member (400); and said endotracheal tube shape modulating device (l000) has a coronal relaxed state inWhich the projection of said directing mechanism (600) in a coronal plane is extendingessentially along the projection of the longitudinal extension of said rigid holloWmember (400) in the same coronal plane, and a coronal compressed state in Which theprojection of the distal end of said directing mechanism (600) in a coronal plane islocated laterally relative the projection of the longitudinal extension of said rigid holloW member (400) in the same coronal plane.

3. Endotracheal tube shape modulating device (l000) according to any one of thepreceding claims, further comprising a tube holder arranged to disengageably lock anendotracheal tube in relation to said rigid holloW member (400) for prevention ofrelative movement of said endotracheal tube in relation to said holloW member (400) in a proximal or distal direction.

4. Endotracheal tube shape modulating device (1000) according to any one of thepreceding claims, Wherein said directing mechanism (600) comprises a first directingelement (610) and a distal directing element (630), said distal directing element (630)being pivotally connected at its proXimal end for enabling pivoting movement in a sagittal plane.

5. Endotracheal tube shape modulating device (l000) according to claim 4, Wherein saidfirst directing element (6 10) being pivotally connected to the distal end of said rigid holloW member (400) for enabling pivoting movement in a sagittal plane.

6. Endotracheal tube shape modulating device (l000) according to claim 4, furthercomprising one or two two aXis joints (603) pivotally connected to the distal end of saidrigid holloW member (400) or to the distal end of said first directing element (6l0), for enabling pivoting movement in a sagittal plane.

7. Endotracheal tube shape modulating device (l000) according to any one of claims 4to 6, further comprising a second directing element (620) being pivotally connected at both of its proximal end and distal end.

8. Endotracheal tube shape modulating device (l000) according to any one of claims 2or 3, Wherein said directing mechanism (600) comprises a first directing element (6l0)having a first directing element proXimal bore (6l4) and a first directin g element distalbore (6l5), a second directing element (620) having a second directing elementproXimal bore (624) and a second directing element distal bore (625), and a distaldirecting element (630) having a distal directing element proXimal bore (635), Whereinsaid first directing element (6l0) is pivotally connected to said rigid holloW member(400) by a sin gularity or plurality of connecting pins (650), Which together areeXtending through said first directing element proXimal bore (6l4) and a rigid holloWmember bore (403) in a direction eXtending essentially from the ventral side to thedorsal side of said endotracheal tube shape modulating device (l000); said second directing element (620) being pivotally connected to said first directingelement (6l0) by a singularity or plurality of connecting pins (650), Which together are eXtending through said second directing element proXimal bore (624) and said first 21 directing element distal bore (6l5) in an essentially lateral direction of said endotrachealtube shape modulating device (l000); said distal directing element (630) being pivotally connected to said second directingelement (620) by a singularity or plurality of connecting pins (650), which together areeXtending through said distal directing element proXimal bore (635) and said seconddirecting element distal bore (625) in an essentially lateral direction of said endotrachealtube shape modulating device (l000); the distal end of each of said left directing wire (520) and said right directing wire (525)being connected to the left and right side, respectively, of either of said first directingelement (6l0), said second directing element (620) and said distal directing element(630); and the distal end of each of said upper directing wire (5 l0) and said lower directing wire (5 l5) being connected to the ventral and dorsal side, respectively, of said distaldirecting element (630).

9. Endotracheal tube shape modulating device (l000) according to any one of claims 2or 3, wherein said directing mechanism (600) comprises a first directing element (6l0)having a first directing element proXimal bore (6l4) and a first directin g element distalbore (6l5), a distal directing element (630) having a distal directing element proXimalbore (635), and a two aXis joint (603), wherein said two aXis joint (603) being pivotally connected to said rigid hollow member (400)by a singularity or plurality of connecting pins (650), which together are extendingthrough a two aXis joint first bore (604) and a rigid hollow member bore (403); said first directing element (6l0) being pivotally connected to said two aXis joint (603)by a singularity or plurality of connecting pins (650), which together are extendingthrough said first directing element proXimal bore (6l4) and a two aXis joint secondbore (605); said distal directing element (630) being pivotally connected to said first directingelement (6l0) by a singularity or plurality of connecting pins (650), which together areeXtending through said distal directing element proXimal bore (635) and said firstdirecting element distal bore (6l5); the distal end of each of said left directing wire (520) and said right directing wire (525)being connected to the left and right side, respectively, of either of said first directing element (6l0) and said distal directing element (630); and 22 the distal end of each of said upper directing wire (5 10) and said lower directing wire(5 l5) being connected to the ventral and dorsal side, respectively, of said distal directing element (630).

10. Endotracheal tube shape modulating device (1000) according to claim 9, whereinsaid two aXis joint first bore (604) is essentially extending in a direction of either aventral-dorsal direction and a lateral direction; said two aXis joint second bore (605) is extending in a direction essentiallyperpendicular to the direction of said two aXis joint first bore (604); and the direction of said distal directing element proXimal bore (635) and said first directing element distal bore (6l5) is extending essentially in lateral direction.