Medical apparatus and method for closing an aperture in a tissue

Abstract

The present invention relates to a medical apparatus for closing an aperture (302), an incision, a puncture, a passage through tissue and / or a communication with a blood vessel or other body lumen (short: aperture) of a tissue (301) of a patient, the medical apparatus comprising a closing device holder (802), for releasably receiving one or more closing devices (600); and a retracting unit (100) to come into contact with opposite sides of the aperture (302) and for retracting them and / or for spreading the aperture (302) causing it to change its shape into a slit or a slit-like or a more slit-like aperture (302) or to spread or to augment the dimension or diameter of the aperture (302) in at least one or in exactly one dimension of the aperture (302).

Description

[0001] Medical apparatus and method for closing an aperture in a tissue

[0002] The present invention relates to a medical apparatus for closing an aperture or opening according to the preamble of claim 1 , a method for closing an aperture according to the preamble of claim 19 , a method according to claim 21 , a closing device according to claim 22 , and a set according to claim 23 .

[0003] The present invention relates generally to a medical apparatus ( in short : apparatus ) and methods for engaging tissue and / or closing openings through tissue , and more particular for closing apertures in a blood vessel or other body lumen, which is an alternative to suturing; and, more particularly, relates to a closure apparatus having applications for closure of openings in body organs or blood vessel walls , in particular after invasive procedures in a patient ' s system, and corresponding methods of use .

[0004] An obj ect of the present invention may be to propose a further medical apparatus for closing an aperture , methods , a closing device and a set .

[0005] The above-mentioned obj ect is achieved by the medical apparatus for closing an aperture , e . g . , having the features of claim 1 . It is further achieved by the method for closing an aperture having the features of claim 19 , the method according to claim 21 , the closing device having the features of claim 22 and the set according to claim 23 . In all of the aforementioned and following statements , the use of the expressions "may be" or "may have" and so on, is to be understood synonymously with "preferably is" or "preferably has" , and so on respectively, and is intended to illustrate an embodiment according to the present invention .

[0006] Whenever numerical words are mentioned herein, the person skilled in the art shall recogni ze or understand them as indications of numerical lower limits . Hence , unles s this leads to a contradiction evident for the person ski lled in the art , the person skilled in the art shall comprehend for example "one" as encompassing " at least one" . This understanding is also equally encompassed by the present invention as the interpretation that a numerical word, for example , "one" may alternatively mean " exactly one" , wherever this is evidently technical ly possible in the view of the person skilled in the art . Both of these understandings are encompassed by the present invention and apply herein to all used numerical words .

[0007] I f it is disclosed herein that the subj ect-matter o f the present invention comprises one or several features in a particular embodiment , it is also respectively disclosed herein that the sub ect-matter according to the present invention expressly does not comprise this or these features in other embodiments which likewise are according to the present invention, e . g . in the sense of a disclaimer . For each embodiment mentioned herein, the opposite embodiment , e . g . formulated as a negation, is also disclosed . The present invention thus proposes a medical apparatus for closing an aperture , an incision, a puncture , a passage through tissue and / or a communication with a blood vessel or other body lumen ( in short : aperture ) of a tissue of a patient . Herein, the medical apparatus comprises a closing device holder for releasably receiving and / or holding one or more closing devices .

[0008] The medical apparatus further optionally comprises a retracting unit . The retracting unit may be designed or arranged to come , during use of the medical apparatus , into contact with, preferably opposite sides of the tissue of the aperture in order to retract them or the tissue and / or in order to spread the aperture , optionally causing it to change its shape into a slit or a slit-like or a more slit-like aperture . To this end, or for achieving this , the retracting unit may be suitably configured . For example , this retracting or this change may be achieved by widening a gap or distance between parts of the retracting unit ( e . g . between retracting devices or their arms ( i f provided) or tips thereof ) which in turn may result in spreading or augmenting the dimension or diameter of the aperture in at least one or in exactly one dimension of the aperture .

[0009] Moreover, methods are proposed . The first method encompasses the step of providing and / or setting up a medical apparatus according to the present invention for its use , and the second method relates to the step of closing the aperture by using the medical apparatus .

[0010] The set according to the present invention comprises or consists of a medical apparatus according to the present invention and optionally further a guide wire . In this , the medical apparatus comprises in turn a closing device holder, a retracting device holder, and a deploying device , each as described herein .

[0011] Advantageous developments of the present invention are each subj ect-matter of the dependent claims and embodiments .

[0012] Whenever an embodiment is mentioned herein, it represents an exemplary embodiment according to the present invention . Whenever an invention is mentioned herein, the present invention is meant .

[0013] Embodiments according to the present invention may comprise one or several of the features mentioned supra and / or in the following in any combination which is technically possible .

[0014] In some embodiments , the retracting unit of the medical apparatus according to the present invention compri ses at least one retracting device holder and at least one retracting device . The latter may preferably be at least partially received in the retracting device holder . The retracting device may optionally be at least partially received in the retracting device holder, preferably in a releasable manner, and is preferably arranged there in a moveable or slidable manner with respect to the retracting device holder .

[0015] The retracting device holder may have both a distal end, preferably configured to be advanced or extended through or into the aperture to be closed, and a proximal end . A mechanism for moving the retracting device into or out of the retracting device holder may be provided .

[0016] In some embodiments , at least two retracting devices of the medical apparatus according to the present invention are captured within the retracting device holder in a releasable manner . In particular, they are captured such that they are arranged to be at least partly released from the retracting device holder by manipulating the retracting device holder or a mechanism configured to do so when required, in particular in order to be positioned below the opening level of the aperture to be closed .

[0017] In several embodiments , the retracting device holder and / or the retracting device of the medical apparatus according to the present invention are configured to retract the opposite sides of the aperture , in particular such that the aperture changes its shape . For example , the aperture may change from a rather round shape to a slit aperture . Preferably, this results in an extended transverse diameter that is at least double the length of the retracted longitudinal diameter of the aperture . "Transverse" may refer to a direction perpendicular to the longitudinal direction of the vessel . The longitudinal diameter may run in the direction of the longitudinal axis of the vessel .

[0018] In some embodiments , the retracting unit of the medical apparatus according to the present invention compri ses at least a retracting device having at least one of the following : a first side and an opposite second side , a first arm and a second arm, - a first retracting device and a second retracting device , and / or

[0019] - a first retracting device holder and a second retracting device holder .

[0020] In certain embodiments , an optional knob and / or a handle member or handle member casing ( or at least or part thereof , respectively) of the medical apparatus is made from resin, plastic, glass fiber, wood, metal or composite materials or combinations of the material s mentioned here . In other embodiments , the optional knob and / or the handle member or handle member casing ( or at least or part thereof , respectively) of the medical apparatus is not made from resin, or not from plastic, or not from glass fiber, or not from wood, or not from metal or not from composite materials or not from combinations of the materials mentioned here .

[0021] In some embodiments , the handle member or its casing comprises at least one slider, e . g . , for the user . In others , it does not comprise any slider .

[0022] In some embodiments , the handle member or its casing comprises at least one rotational element , e . g . , for the user, that translates rotation into translation . In others , it does not comprise such a rotational element .

[0023] In several embodiments , the mechanism may comprise or consist of a vacuum device configured to amend the shape of the retracting device , the retracting unit or any other component such that the first side or the first arm, and so on, is moved apart or away from the second side or the second arm, and so on . The vacuum device may be arranged to suck a fluid (e. g., air) from an inner, preferably closed, lumen of, e.g., the retracting unit such that the cross section of that component, e.g. the retracting unit, is changed: by attempting to achieve a vacuum inside the lumen, the cross section of, e.g., the retracting unit will increase in a first dimension but decrease in a second dimension perpendicular to the first one. That way, opposite first and second sides of, e.g., the retracting unit will move away from each other while the circumference of the retracting unit is kept constant.

[0024] The preferably closed lumen which is in fluid communication with the vacuum device may in at least one state (having applied vacuum or not) have a cross section that is longer in a first direction thereof than in a second direction perpendicular to the first one.

[0025] In some embodiments, the retracting unit or the retracting device has a curve or a step or it bends on its front side or on its rear side that might be used as a stop or give the surgeon tactile feedback while partly withdrawing the medical apparatus from the vessel lumen. The curve, step or the like may indicate that the tip of the medical apparatus, or its retracting unit, retracting device or the like has come to rest at the rim of the vessel or the aperture. This, in turn, indicates that the medical apparatus is in a suitable position for deploying the closing device. To achieve this, the curve, step or the like is arranged under a pre-determined distance from, e. g., the free end of the medical apparatus or the retracting device. Also, the curve, step or position at which it is bent may serve as protection against pulling the medical apparatus too far out from the vessel lumen before releasing the closing device .

[0026] In several embodiments , the medical apparatus does not comprise vacuum device or source and / or is not connected to one .

[0027] In some embodiments , the medical apparatus is not a pressure stabili zer .

[0028] In several embodiments , parts of the retracting device deviate or part from each other when released or in the unstressed state and / or when used for retracting is sue .

[0029] In several embodiments , the retracting device and the closing members , or parts thereof , respectively, may exit , at least in part , from the same handle member .

[0030] In some embodiments , the retracting unit is designed to come into contact with, e . g . , opposite sides , of the aperture or the tissue surrounding the aperture and for retracting them and / or for spreading the aperture causing it to change its shape into a slit or a slit-like or a more slit-like aperture or to spread or to augment the dimension or diameter of the aperture in at least one or in exactly one dimension of the aperture by opening a space or gap between parts of the retracting device , e . e . , by moving arms or tips of these arms , i f provided, of the retracting device apart from each other, respectively .

[0031] In several embodiments , the medical apparatus according to the present invention comprises at least one closing device comprised in the closing device holder . In some embodiments , the closing device of the medical apparatus according to the present invention is at least partially comprised within the closing device holder in a stressed state of the closing device . In particular , it is comprised within the distal end of the closing device holder, in particular when the closing device is in an undeployed state . Herein, the closing device has preferably two or more ends and a j unction connecting with the two or more ends , e . g . , via two or more arms .

[0032] In several embodiments , the closing device of the medical apparatus according to the present invention is comprised within the closing device holder such that when the closing device is manipulated to exit the distal end of the closing device holder during the use of the medical apparatus , the closing device releases its stress , or part of it , e . g . , by bending the two or more arms outside of the closing device holder . Thereby, the two or more ends are arranged to perforate the inner wall of the tissue surrounding the aperture .

[0033] In some embodiments , at least part of the closing device, the retracting device , the retracting device holder of the medical apparatus according to the present invention is made of a deformable shape memory alloy and / or has a sel f-expanding shape memory section or a wire body .

[0034] In several embodiments , at least part of the closing device, the retracting device , the retracting device holder of the medical apparatus according to the present invention is made of Nitinol . In some embodiments , at least part of the closing device , the retracting device , the retracting device holder of the medical apparatus according to the present invention is made of biocompatible and / or bio-absorbable material .

[0035] In several embodiments , the biocompatible and / or bio- absorbable material is at least one material selected from the group consisting of Ti , Ti alloys , Nitinol , stainless steel , polymeric materials , and ceramic .

[0036] In some embodiments of the medical apparatus according to the present invention, the closing device or parts thereof curl into a closed form (having, e . g . , a through- opening surrounded by arm, struts or the like of the closing device ) when in a stress- free state .

[0037] In several embodiments of the medical apparatus according to the present invention, the closing device or parts thereof curl into a loop- or ring- or circle-like shape when in a stress- free state .

[0038] In several embodiments of the medical apparatus according to the present invention, the closing device after deployment has a cross-sectional dimension ranging from 10 micrometers to 1 centimeter, preferably from 40 micrometers to 200 micrometers , more preferably from 50 micrometers to 100 micrometers .

[0039] In some embodiments , the closing device has two arms .

[0040] In some embodiments , at least one of the arms has a or one first bending direction and a or one second bending direction . Hence , a or one first section of the arm is bent in the first bending direction whereas a or one second section of this arm is bent in the second bending direction, wherein the first bending direction and the second bending direction are at least one of not identical to each other, opposite to each other and facing away from each other, or the like .

[0041] In some embodiments , in a closed state of the closing device or the vessel aperture , the end or tip of a first one of the arms points away from a second one of the arms , whereas the end or tip of the second arm points away from the first arm .

[0042] In some embodiments , the medical apparatus comprises or consists of a handle member ( or handle or handle device ) .

[0043] In some embodiments , in order to activate or advance the retracting device , the handle member may have a first slider and optionally also a second slider arranged to be moved by the user, preferably in a longitudinal direction of the handle member .

[0044] Optionally, in its end position, or in another position, the first slider may be locked in place . A suitable mechanism may be provided, e . g . , in the handle member .

[0045] In some embodiments , all or some of the closing device holders are parallel to each other, fully or only in parts thereof .

[0046] In some embodiments , the casing of the handle member comprises an opening in which a switch can be moved by the user to advance the closing device holders relative to the casing of the handle member . In certain embodiments , the closing device holders are arranged to remain parallel to each other throughout the closing of the vessel aperture . In other embodiments , they are arranged to part or deviate from each other when being advanced towards the vessel aperture .

[0047] In some embodiments , the closing device holders are not parallel to each other, or only parts of them ( e . g . their proximal parts ) are parallel , but , for example, not their distal parts ( their tips , e . g . ) . In certain embodiments , the proximal parts are parallel to each other . In some embodiments , the distal parts are under an - optionally constant - angle with regard to each other .

[0048] In some embodiments , the distance between the tips or distal ends of some of the closing device holders - for example when having been advanced towards the vessel aperture for closure - is larger than the diameter of the opening of the medical apparatus or the handle member from which the closing device holders exit for clos ing the vessel aperture .

[0049] In particular embodiments , the distance between the tips or distal ends or between any other corresponding parts of the closing device holders is equidistant between neighboring closing device holders in their unstres sed or fully deployed state and / or when advanced for closing the vessel aperture .

[0050] In certain embodiments , the distance between the tips or distal ends of some of the retracting devices or of their arms - for example when having been advanced towards the vessel aperture for closure or in their unstressed or fully deployed stated - is larger than the distance between the tips or distal ends of some of the clos ing device holders mentioned supra .

[0051] In some embodiments , a delivery support for assuring that the closing device holders deviate or part from each other when being advanced towards the vessel aperture is provided .

[0052] In some embodiments , the delivery support comprises a wire , a wire net or structure , or consist thereof , respectively .

[0053] In some embodiments , the delivery support is a foldable and / or unfoldable element .

[0054] In some embodiments , at the outer or lateral sides of the closing member, of the closing device holders or of the delivery support bumpers are arranged .

[0055] In some embodiments , the handle member comprises a sleeve or another, preferably rotatable element or cylindric, element with a - optionally U- or V-shaped - guide slot ( guidance groove ) . The guide slot can be part of the sleeve ' s outer surface or added to the latter .

[0056] In some embodiments , the guide slot comprises a first slot section and a second slot section each being connected with each other by another slot section, called a turning point .

[0057] In some embodiments , the handle member, the knob or the sleeve itsel f comprises an elastic element , a spring or the like arranged to also guide the pin through the turning point of the guide slot . In some embodiments, the retracting device comprises a multitude (here: two) of arms.

[0058] In some embodiments, an arm of the retracting device comprises two legs, called an outer leg and an inner leg.

[0059] In some embodiments, the outer leg and the inner leg may be welded to each other in or by a welding section.

[0060] In some embodiments, the outer leg and the inner leg surround or circumscribe one or two middle openings which may be trough-openings, or form the latter between them.

[0061] In some embodiments, the inner leg is straight or substantially straight.

[0062] In some embodiments, the outer leg is bent such that it has or forms an indentation, a bulge or a dent.

[0063] In some embodiments, the arms of the retracting device each exits through separate openings of the retracting unit. In other embodiments, some or all of the arms exit through a common opening of the retracting unit.

[0064] In some embodiments, at least one of the openings of the retracting unit through which the arms exit in use has a width that is smaller than its length.

[0065] In some embodiments, at least one of the openings of the retracting unit and / or the closing device holder through which at least one arm exits has an oval opening area. Other shapes of the openings of the retracting unit and / or the closing device holder, e . g . a rectangular shape , are also encompassed by the present invention .

[0066] In some embodiments , the medical apparatus according to the present invention further comprises a pushing device , preferably extending through the proximal end of the closing device holder, for the manipulation of the closing device . The pushing device may be configured not to deform the closing device by acting on it , e . g . , by pushing it .

[0067] In several embodiments of the medical apparatus according to the present invention, the pushing device is or comprises a rod or a piston .

[0068] In some embodiments , the medical apparatus according to the present invention further comprises a holding or withdrawing device extending through the proximal end of the closing device holder for the manipulation of the closing device . Herein, said holding device is , in particular releasably, attached to the closing device or connected therewith .

[0069] In several embodiments , the holding device of the medical apparatus according to the present invention is a string or a suture .

[0070] In some embodiments , the closing device holder of the medical apparatus according to the present invention has one or more grooves on the inner wall of the closing device holder and / or one or more grooves on the pushing device for guiding the holding device along the longitudinal direction of the closing device holder , preferably through or along the groove ( s ) . In several embodiments of the medical apparatus according to the present invention, the distal end of the closing device holder has two or more channels on the wall of the closing device holder . These channels allow one or more ends of the closing device to exit the closing device holder upon manipulation of the medical apparatus or when required by the user . The ends may exit from one side or both sides of the closing device holder . The channels may be slit-like . The channels or the proximal ends thereof may be exceeded in a distal direction of the closing device holder by the distal end .

[0071] In some embodiments of the medical apparatus according to the present invention, the distal end of the closing device holder has at least one channel or two channels arranged opposite to each other on the wall , in particular in the circumference of the closing device holder, of the closing device holder .

[0072] In several embodiments of the medical apparatus according to the present invention, the retracting device holder is or comprises an elongated tube . This elongated tube comprises or consists of , e . g . , metal or plastic and is preferably configured to capture a retracting device .

[0073] The closing device holder may have a distal end for being advanced or extended through or into the aperture o f the tissue, and a proximal end in particular suitable for providing access for manipulating a closing device when and i f received in the closing device holder .

[0074] In some embodiments , at least one of the closing device holder and the retracting unit is at least one of slidably and moveably arranged within the medical apparatus with respect to each other, to other elements of the medical apparatus , and / or to a casing or an outer sheath of the medical apparatus .

[0075] In some embodiments , the medical apparatus comprises an outer housing, sheath or casing that comprises some or all elements ( except for the housing or casing and the like , of course ) of the medical apparatus , in particular the closing device holder and / or the retracting unit .

[0076] In some embodiments , the medical apparatus comprises a lumen for guiding and / or encompassing a guide wire . The lumen may be open to both the distal end and the proximal end of the medical apparatus or to j ust one of those .

[0077] In some embodiments , the medical apparatus comprises several lumen or openings . One of them may house a first closing device holder, another one may house a second closing device holder, a retracting device holder and / or any other element of the medical apparatus , for example .

[0078] Any lumen of the medical apparatus may be a through- opening of the medical apparatus , preferably extending in a longitudinal direction of the medical apparatus .

[0079] In some embodiments the medical apparatus has an outer housing or unit that is , along its entire length or along only parts of it , not flexible and / or flexible .

[0080] In several embodiments of the method according to the present invention, the method comprises the following further steps : introducing parts of the retracting unit into the aperture ;

[0081] - contacting opposite sides of the aperture with the retracting unit or elements comprised by it ;

[0082] - retracting the opposite sides of the aperture and / or spreading the aperture with the retracting unit or elements comprised by it ; and

[0083] - releasing at least one closing device from the closing device holder and connecting the opposite sides of the aperture to each other with the closing device .

[0084] The steps contacting and retracting may be one and the same step . They may be carried out in a common step such as advancing the medical apparatus , or set , or part thereof through the aperture and into the vessel .

[0085] In some embodiments of the method according to the present invention, the step of retracting opposite sides of the aperture and / or spreading the aperture causes the aperture to change its shape , e . g . , into a slit or a slit-like or a more slit-like aperture . This change may result in spreading or augmenting the dimension or diameter of the aperture in at least one or in exactly one dimension of the aperture .

[0086] In some embodiments at least one of the closing device holder and the retracting device holder is a partly hollow tube . In some embodiments at least one of the closing device holder and the retracting device holder are arranged within a common casing or housing, preferably slidable or moveable with respect to that casing .

[0087] In some embodiments the closing member is identical to the closing device holder or the same component .

[0088] In some embodiments the retracting unit is identical to the retracting device holder or the same component .

[0089] In some embodiments the retracting unit and the closing member are embodied by one device only .

[0090] In some embodiments the device has no guide wire . I t may, however, have a lumen for running a guide wire through the length of the device and / or in the direction of its length .

[0091] In some embodiments the closing device is a staple or a clip, a wire structure , or the like . It may have any features disclosed herein in any arbitrary combination .

[0092] In some embodiments the closing device holder is not configured to ej ect or to release the closing devices , in particular staples or clips , in a first direction wherein a component of the device or of the closing device holder configured to ej ect the closing device or to assist in ej ecting them, is arranged to be moveable at best ( or ideally only) in the first direction or at best substantially in the first direction . However, in those embodiments , that component is not configured or arranged to be moveable in a second direction which is substantially perpendicular to the first direction . In some embodiments at least one of the closing device holder and the device has no devices configured for plastically deforming the closing devices , in particular not for plastically deforming them while there are ej ected or released . Also , there is preferably no devices provided for closing a closing device .

[0093] In some embodiments the closing device holder is configured to simultaneously ej ect or release two or more closing device . For example , the closing device may be ej ected from one common opening of the holder through which they leave side by side . Alternatively, the configuration may be such that two or more closing device may leave the closing device holder or the device through separate openings but at the same time . Also , they may be arranged to leave not at the same time , but one after the other, for example first the middle then the outer closing device .

[0094] In some embodiments , the closing device holder is configured such that the closing device can only be ej ected or released in the longitudinal direction o f the closing device holder .

[0095] In some embodiments , the closing device holder is configured such that the closing device can only be ej ected or released at the same position with respect to the length or the longitudinal direction of the closing device holder .

[0096] In some embodiments the retracting unit comprises at least two elements that move apart from each other while retracting the aperture , for example , two sides , two arms , two retracting devices or two retracting device holders .

[0097] In some embodiments the retracting unit and the closing device holder are separate from each other, and, in particular, may move separately from each other . In other embodiments , they are interconnected to each other or embodied by the same unit such that they cannot move independently from each other .

[0098] In some embodiments the retracting unit and the closing device holder are spaced apart from each other such that the closing device holder is configured to ej ect or release the closing device or devices into the tissue in order to have them close the rim or seam of the long sides of aperture in retracted state of the aperture , that is while the aperture is being retracted or spread by the retracting unit .

[0099] In some embodiments at least one of the components of the retracting unit configured to retract the opposite sides of the aperture by directly touching them is an elongated or oblong section . At least one of them may have the shape of a pole , a tube or the like , and they are , preferably, straight .

[0100] In some embodiments at least one of the components of the retracting unit configured to retract opposite sides of the aperture by directly touching them ( such as the first and the second arms or sections , the first and the second retracting devices and / or the first and the second retracing device holder ) does not comprise one or more hinges , articulations , j oints or sections where it bends , in particular not in a middle section thereof , more particular not facing to opposite directions from each other .

[0101] In some embodiments the components of the retracting unit configured to retract the opposite sides of the aperture by directly touching them have a free distal end .

[0102] In some embodiments , some or all of the components of the retracting unit configured to retract opposite sides of the aperture by directly touching them are configured to move with respect to each other in a first common plane while retracting the aperture . Optionally, in these or in di fferent embodiments at least one closing device extends ( e . g . , in a deployed state of the closing device , e . g . , when being released or ej ected) entirely or substantially in a second plane . Also , the closing device may optionally close in the second plane . For example , the closing device may comprise arms or tines that move towards each other upon closing or deploying . That movement can also take place in substantially one plane, namely the second plane . The first plane and the second plane may intersect each other . They may be substantially perpendicular to each other .

[0103] In some embodiments , some or all of the components of the retracting unit configured to retract opposite sides of the aperture by directly touching them are configured to move with respect to each other in a first direction while retracting the aperture . Optionally, in these or in di f ferent embodiments the device is configured to ej ect or to release the at least one closing device in a second direction . The first direction and the second direction may be di f ferent from each other . In fact , they may be perpendicular or substantially perpendicular to each other . Hence , the direction of retracting may be perpendicular or substantially perpendicular to the direction in which the closing device is ej ected or released and / or in which the closing device closes when the device is used by the surgeon .

[0104] In some embodiments the first and the second retracting devices , or first and second arms or sections thereof , are connected to each other by j ust one hinge or j oint or hinge or j oint section . That hinge or j oint or section may be arranged to move - preferably exclusively - inside the retracting device holder and / or along the longitudinal axis of the medical device or the of the retracting device holder . Additionally, or alternatively, that hinge or j oint or section may be arranged to move - preferably exclusively - in the second direction, not , however, in the first direction . Hence , in those embodiments the hinge or j oint or section may optionally not move in the direction in which the opposite sides of the aperture are retracted or spread .

[0105] According to the present invention, a medical apparatus for closing an aperture of a tissue is also suggested, comprising a closing device holder, wherein said closing device holder has a distal end for extending through the aperture of the tissue in a deployed state of the medical apparatus , and a proximal end for providing access for manipulation of a closing device ; and a closing device at least partially captured in a stressed state within the distal end of the closing device holder when the medical apparatus or the closing device is in an undeployed state ; wherein the closing device has two or more ends and a j unction connecting with the two or more ends via two or more arms ; wherein the closing device is configured relative to the closing device holder so that when the closing device is manipulated to exit the distal end of the closing device holder during the deployment of the medical apparatus or the closing device , the closing device releases its stress by bending the two or more arms outside of the closing device holder, whereby the two or more ends perforate the inner wall of the tissue surrounding the aperture .

[0106] According to the present invention, a method for closing an aperture of a tissue is also suggested, the method encompassing the steps : providing a medical apparatus according to the present invention; closing the aperture by means of the medical apparatus .

[0107] In some embodiments according to the present invention, at least part of the closing device is made of a deformable shape memory alloy .

[0108] In some embodiments according to the present invention, at least part of the closing device is made of Nitinol . In some embodiments according to the present invention, at least part of the closing device is made of biocompatible and / or bio-absorbable material .

[0109] In some embodiments according to the present invention, the biocompatible and / or bio-absorbable material is at least one material selected from the group consisting of Ti , Ti alloys , Nitinol , stainless steel , polymeric materials , and ceramic .

[0110] In some embodiments according to the present invention, the closing device curls into a closed form when in a stress- free state .

[0111] In some embodiments according to the present invention, the closing device curls into a loop- or ring- or circlelike shape when in a stress- free state .

[0112] In some embodiments according to the present invention, the closing device after deployment of the medical apparatus has a cross-sectional dimension ranging from 10 micrometers to 1 centimeter, preferable from 40 micrometers to 200 micrometers , more preferably from 50 micrometers to 100 micrometers .

[0113] In some embodiments according to the present invention, the medical apparatus comprises a pushing device extending through the proximal end of the closing device holder for the manipulation of the closing device .

[0114] In some embodiments according to the present invention, the pushing device is a rod or piston . In some embodiments according to the present invention, the medical apparatus comprises a holding device extending through the proximal end of the closing device holder for the manipulation of the closing device , wherein said holding device is attached with the closing device .

[0115] In some embodiments according to the present invention, the holding device is a string or suture .

[0116] In some embodiments according to the present invention, the closing device holder has one or more grooves on the inner wall of the closing device holder and / or one or more grooves on the pushing device for guiding the holding device along the longitudinal direction of the closing device holder .

[0117] In some embodiments according to the present invention, the distal end of the closing device holder has two or more channels on the wall of the closing device holder, allowing the one or more ends of the closing device to exit the closing device holder when deploying the closing device .

[0118] In some embodiments according to the present invention, the distal end of the closing device holder has two channels arranged opposite to each other on the wal l of the closing device holder .

[0119] Most of the systems that are state of the art like utilizing plugs , clips or sutures can only close rather smaller si ze arterial perforation up to 10 French ( Fr ) and are only approved for arterial access sites . Some of the systems are used of f-label for closing larger arterial or venous punctures .

[0120] The present invention may advantageously provide a more ef fective method and a medical apparatus for sealing large bore punctures up to 30 French ( Fr ) and larger in veins and other passages through tissues .

[0121] The present invention allows to connect tissue segments together or to close and / or seal opening through ti ssue , such as very large bore vascular perforations in the venous system in particular the Vena femoralis .

[0122] Such large vascular access and perforations are required for more complex interventional procedures like transseptal mitral and tricuspid valve repair and prosthesis implantation .

[0123] The femoral vein has a diameter of approximately 8 mm or 24 French ( Fr ) , and more , allowing introduction of systems with a similar diameter . It is very challenging to close such large bore perforations of the vein with a percutaneous system utili zing plugs , sutures or clips . When closing such large bore perforations in a circular or longitude way, the risk of a vascular stenosis i s high .

[0124] According to the present invention, a particular technique is advantageously used to stretch the perforation in a direction orthogonal to the vessel long axis and to suture the perforation close along this stretch . In this way narrowing of the vessel lumen is avoided . The present invention allows closing a large bore vascular perforation in particular in veins by stretching the perforation in an orthogonal direction to the vessel long axis and placing single clips along the stretch that close the perforation along the stretched line .

[0125] In some embodiments , the medical apparatus may include a handle member and a tube set coupled to the handle member on one side (not shown) and on the other side , retracting units and closing members that are deployed subsequently or simultaneously in a tissue aperture . The handle member may also include any number of mechanisms (not shown) necessary to deploy a retractor and closing members . The retracting units and closing members are deployed through a casing that allows these units and members to be disposed at least partially in the aperture or lumen of a vessel in a controlled manner, in particular along a guiding structure , like a guide-wire or other rail (not shown) that is commonly placed in a vessel for performing interventional procedures .

[0126] The retracting units optionally include two retracting device holders with distal ends configured for extending through the aperture and to be positioned at the opposing inner side of the aperture to be closed . The retracting units may be configured to move apart , retracting the opposing sides of the aperture and stretching the aperture which approximates the opposing sides of the aperture between the retracting devices , such that the aperture becomes straight with one extended long diameter and an orthogonal retracted short diameter .

[0127] The closing member optionally includes one or more closing device holders with a distal end extending through the aperture to be closed, the closing device holders having closing devices mounted at , e . g . , the distal end . The closing devices are arranged for engaging the tissue wall as the closing device holders are withdrawn .

[0128] The closing devices are preferably pointed needles that penetrate the tissue wall surrounding the aperture when the closing device holders are withdrawn . When the closing devices are engaged with the tissue wall it can be detected as a firm resistance to further withdrawal .

[0129] The closing devices are then deployed, bend further into a circular structure and draw the ends of the transversely retracted aperture together in a manner such that it closes the aperture in a straight line .

[0130] The closing devices optionally comprise a plurality of round needles of si ze , orientation and form such that when the closing devices are moved outwardly from inside of the aperture , the closing devices bend in an anchor like manner according to the preset memory shape of the closing devices , perforate the tissue wall and also grab tissue that is in close proximity to the wall causing the tissue surrounding the perforation to be drawn into close proximity of the closed aperture , such that the aperture can be closed and the drawn-in surrounding tissue will additionally seal the tissue closure .

[0131] The closing device , or the plurality of closing devices , can optionally be disengaged from the closing device holders and delivery mechanism, and left in place . With the tissue aperture closed in such way, blood stasis can be achieved in a vessel by leaving the closing devices attached to the tissue wall . The closing devices may be constructed of metal , plastic or bio-absorbable material preferably having a memory material ef fect .

[0132] In some embodiments according to the present invention, for use in closing an aperture , incision, puncture , or other passage through tissue , communication with a blood vessel or other body lumen, a medical apparatus is suggested comprising one or more retracting units .

[0133] The retracting units have , e . g . , two retracting device holders with a distal end for extending through the aperture to be closed and with a proximal end for selectively providing manipulation .

[0134] In some embodiments according to the present invention, for use in closing an aperture in a tissue , a medical apparatus is suggested, the medical apparatus comprising closing members , the closing members having closing device holders with a distal end for extending through the aperture to be closed and having a proximal end for selectively providing manipulation; and having clos ing devices captured at the distal end of the said clos ing device holders to be deployed and whereby said manipulation of said closing device holders and deployment of closing devices causes the aperture to be closed .

[0135] In some embodiments according to the present invention, the medical apparatus comprises a set of retracting units . In some embodiments according to the present invention, the medical apparatus comprises an indication for the user indicating the orientation or direction of the retracting units of the medical apparatus , e . g . being embodied as a sign, an arrow, or the like .

[0136] In some embodiments according to the present invention, the medical apparatus further includes delivery devices for delivering said closing device holder to an operative proximity with the aperture , said delivery device being slidably connected, e . g . , to said closing device holder .

[0137] In some embodiments according to the present invention, the retracting device holder comprises an elongated tube made of metal or plastic capable to capture a retracting device .

[0138] In some embodiments according to the present invention, the retracting units can be moved apart to retract an aperture .

[0139] In some embodiments according to the present invention, the retracting device holder comprises an elongated tube made of metal , plastic or other material capable to capture a retracting device .

[0140] In some embodiments according to the present invention, the closing device holder has a lateral channel at the end of the said elongated tube through which the closing device will leave the closing device holder, avoiding contact of the closing device with a structure opposite to the end of the elongated tube . In some embodiments according to the present invention, the closing member can be manipulated to evenly distribute closing devices along the line to be closed .

[0141] In some embodiments according to the present invention, the closing devices are made of a perforating material , preferably a needle , selected from a class of material including metal , metal alloys , Nitinol , plastics , preferably having memory ef fect characteristics , and having a permanent or bio absorbable protective coating and being bio-absorbable .

[0142] In some embodiments , according to the present invention, the closing devices have a predetermined cross section, a proximal end and two arms each with a pointed end; both arms are the bending portion of the closing device , to expand between a first position when compressed and captured in the said closing device holder into a second position . The closing device is substantially linear and can be moved along the axis inside of the closing device holder in both directions in a compressed or strained state and can be released at the end of the closing device holder, returning the arms to the expanded second position with the arms having a bent shape , forming a ring with two hemi-circles or semi-circles .

[0143] In some embodiments according to the present invention, the closing devices have a preset form that allows connecting the closing devices with said closing device holder .

[0144] In some embodiments according to the present invention, the invention relates to a method for closing an aperture in a wall , incision, puncture , or other passage through tissue , communication with a blood vessel or other body lumen, in particularly, but not exclusively, the wall of a blood vessel , wherein the blood vessel has a lumen carrying blood .

[0145] It encompasses the steps : a . retracting opposite sides of the aperture to be closed, causing the aperture to change the shape from a rather round aperture to a more slit-like aperture with a diminished diameter in axial direction to a vessel long axis and an expanded orthogonal diameter to the ves sel long axis diameter, in preparation for connecting the expanded orthogonal sides of the aperture ; b . inserting and evenly or unevenly deploying one or a plurality of closing devices through the aperture into the vessel lumen, the closing devices are manipulated to engage the vessel wall surrounding the aperture at the extended long sides of the aperture between the shoulders , and to connect the two expanded orthogonal sides of the retracted aperture sides and to close the aperture .

[0146] In some embodiments according to the present invention, the step of closing includes suturing, clamping or similar mechanical approximation of the engaged aperture wall .

[0147] In some embodiments , at least two retracting devices are captured within the retracting device holder in a releasable manner, in particular such that they are arranged to be at least partly released from the retracting device holder by manipulating the retracting device holder, in particular to be positioned below the opening level of the aperture which is to be closed .

[0148] In some embodiments , the retracting device holder and / or the retracting device are configured to retract the opposite sides of the aperture , in particular such that the aperture changes its shape , e . g . from a rather round aperture , to a slit aperture , preferably such that the extended transverse diameter is at least double the length of the retracted longitudinal diameter of the aperture .

[0149] In some embodiments , the mechanism comprises or consists of a shape memory characteristic .

[0150] In some embodiments , the closing device is at least partially comprised within the closing device holder in a stressed state , in particular within the distal end of the closing device holder, in particular when the medical apparatus is in an undeployed state ; wherein the closing device has preferably two or more ends and a j unction connecting with the two or more ends , e . g . , via two or more arms .

[0151] In some embodiments , the closing device is comprised within the closing device holder such that when the closing device is manipulated to exit the distal end of the closing device holder during the use of the medical apparatus , the closing device releases its stress or part of its stress by bending the two or more arms outside of the closing device holder, whereby the two or more ends are arranged to perforate the inner wall of the tis sue surrounding the aperture . In some embodiments , at least part of the closing device , of the retracting device , of the retracting device holder is made of a deformable shape memory alloy and / or has a sel f-expanding shape memory section or wire body .

[0152] In some embodiments , at least part of the closing device , the retracting device , the retracting device holder is made of Nitinol .

[0153] In some embodiments , at least part of the closing device , of the retracting device , of the retracting device holder is made of biocompatible and / or bio-absorbable material .

[0154] In some embodiments , the closing device or parts thereof curl into a closed form when in a stress- free state .

[0155] In some embodiments , the closing device or parts thereof curl into a loop- or ring- or circle-like shape when in a stress- free state .

[0156] In some embodiments , the medical further comprises a pushing device , preferably extending through the proximal end of the closing device holder, for the manipulation of the closing device .

[0157] In some embodiments , the pushing device is a rod or piston .

[0158] In some embodiments , the medical apparatus further comprises a holding device extending through the proximal end of the closing device holder for the manipulation of the closing device , wherein said holding device is attached to the closing device . In some embodiments , the holding device is a string or suture .

[0159] In some embodiments , the closing device holder has one or more grooves on the inner wall of the closing device holder and / or one or more grooves on the pushing device for guiding the holding device along the longitudinal direction of the closing device holder .

[0160] In some embodiments , the distal end of the closing device holder has two or more channels on the wall of the closing device holder, allowing the one or more ends of the closing device to exit the closing device holder upon manipulation of the medical apparatus or when required by the user .

[0161] In some embodiments , the distal end of the closing device holder has at least one channel or two channels arranged opposite to each other on the wall of the closing device holder .

[0162] In some embodiments , the retracting device holder comprises an elongated tube , e . g . , comprising or consisting of metal or plastic, preferably configured to capture a retracting device ) .

[0163] In some embodiments , the method further comprises the steps : introducing parts of the retracting unit into the aperture ; contacting opposite sides of the aperture with the retracting unit or elements comprised by it ; retracting the opposite sides of the aperture and / or spreading the aperture with the retracting unit or elements comprised by it ; and releasing at least one closing device from the closing device holder and connecting the opposite sides of the aperture to each other with the closing device .

[0164] In some embodiments , the step of retracting opposite sides of the aperture and / or spreading the aperture causes the aperture to change its shape into a slit or a slit-like or a more slit-like aperture or to spread or to augment the dimension or diameter of the aperture in at least one or in exactly one dimension of the aperture .

[0165] In some embodiments , the retracting device is configured to retract the aperture in a direction perpendicular to the longitudinal axis of the retracting unit and / or the closing device holder .

[0166] In some embodiments , the retracting device is configured to retract the aperture in a direction with an angle between 90 degrees and 45 degrees relative to the longitudinal axis of the retracting unit and / or the closing device holder . The angle can be 90 degrees , 85 degrees , 80 degrees , 75 degrees , 70 degrees , 65 degrees , 60 degrees , 55 degrees , 50 degrees , 45 degrees or any angle between these degrees . Of course , in other embodiments , the angle may be 0 degrees or between 0 and 45 degrees .

[0167] In some embodiments , the retracting device is configured to retract the aperture in a direction not parallel to the longitudinal axis of the retracting unit and / or the closing device holder .

[0168] In some embodiments , the retracting device or the retracting unit does not have a motor or mechanism, e . g . , for rotating or moving the arms or other parts for retracting opposite sides of an aperture around the axis or parallel to the axis which is the longitudinal axis of the retracting unit and / or the closing device holder .

[0169] In other embodiments , the retracting device or the retracting unit does have a motor and / or a mechanism for acting on the retracting device and / or on the retracting device holder .

[0170] In certain embodiments , the retracting device and the retracting device holder are arranged for not being moveable independently from each other .

[0171] In some embodiments the arms are part , extensions or protrusions of the retracting device holder . For example , the retracting device holder may have two distal tips , or it can terminate in a hal f-moon shape , a C-shape , and / or in any other shape that allows two parts separated by a gap to deviate from each and increase the gap or the distance between them, for example , should the shape of the retractor device holder change . Hence , the two tips mentioned here may be understood as arms as noted herein . Also , what has been stated herein with regard to "arm" may undiminishedly hold true for the tips , the two free ends of the C-shape or the hal f-moon shape mentioned supra .

[0172] The term mechanism as used herein refers in particular to a mechanism comprising moveably arranged parts such as plungers , gears , a motor, and the like .

[0173] In some embodiments , the medical apparatus comprises a deploying device configured to be at least partially releasably received in a lumen of the retracting device holder . The deploying device can comprise a cylindrical shaped body . The cylindrical shaped body can be hol low, partially hollow or solid inside . The distal end section of the deploying device can comprise a conical shaped end section . The very distal end of its tip, end or end section can comprise a spherical shaped tip .

[0174] In some embodiments , the retracting device is positioned at the distal tip, end or end section of the retracting device holder . The retracting device and the retracting device holder are preferably designed integrally with each other and / or preferably are connected to each other in a non-releasable manner or in a manner that does not require releasing during use of the invention .

[0175] In some embodiments , the retracting device comprises a first arm and a second arm ( or consists thereof ) . Preferably, the first arm and the second arm are positioned or provided parallel to each other, preferably at least while positioning the retracting unit into the aperture . In some embodiments , the retracting device comprises a first arm and a second arm ( or consists thereof ) , which are arranged at or in contact with the surface of the deploying device while ( during the ) positioning ( of ) the retracting device to the aperture and which are expanded to a retracted state of the aperture after having pulled the deploying device out of the retracting device holder .

[0176] In some embodiments , the retracting device comprises a first arm and a second arm ( or consists thereof ) , which are releasably attached to or in contact with the surface of the deploying device while advancing the retracting device to or into the aperture and which are expanded to assume a retracting or state of the aperture after pulling out the deploying device from the retracting device holder .

[0177] In some embodiments , the retracting device comprises a first arm and a second arm ( or consists thereof ) , which are arranged at the surface of the deploying device while positioning the retracting device to the aperture and which are expanded passively, without a mechanism to a retracting state of the aperture after pulling out the deploying device from the retracting device holder .

[0178] In some embodiments , the retracting device holder or its lumen exhibits , assumes or shows a first shape or a first cross section, preferably a circular cross-section with a cross section diameter, while positioning the retracting unit into the aperture , and a second shape or a second cross section, preferably an oval cross section with a main axis length, preferably larger than the cross section diameter, after pulling out the deploying device , partly or completely, from the retracting device holder . In some embodiments , the retracting device holder or its lumen exhibits , assumes or shows a first shape or a first cross section, preferably a circular cross-section with a cross section diameter, while positioning the retracting unit into the aperture , and a second shape or a second cross section, preferably an oval cross section with a main axis length, preferably larger than the cross section diameter, preferably an elliptical cross section with two symmetry axes , main axis and minor axis , after pulling out the deploying device , partly or completely, from the retracting device holder .

[0179] In some embodiments , the shape of the closing device holder or of its cross section mainly assumes the second shape or takes on the second cross section, corresponds to it and / or has an oval cross section, preferably with a main axis length slightly smaller than this length .

[0180] In some embodiments , the retracting device holder or parts of it are suf ficiently flexible and / or elastic to enable the closing device holder to adapt the retracting device holder' s shape or cross section while it is being inserted / introduced into the retracting device holder ( and preferably (by it alone being introduced, i . e . , ) without any additional assistance ) . For example , i f the closing device holder or parts of it have an elliptical cross section, in these embodiments the retracting device holder or its inner lumen also assumes an elliptical cross section . Also , i f the deploying device having a round cross section is inserted into the inner lumen of the retracting device holder, the inner lumen may assume a round cross section . Hence , in some embodiments , the retracting device holder or parts thereof defining its inner lumen may have been produced from a material that is flexible or elastic .

[0181] Also , in some embodiments , the retracting device holder or parts thereof which def ine / determine ( defining) its inner lumen may have been produced from a material that has no memory ef fect .

[0182] Hence , in some embodiments , the retracting device holder or parts thereof defining its inner lumen may have been produced from a material that is not flexible and / or not elastic .

[0183] In some embodiments , the medical apparatus comprises one or more bars or other protrusions that are arranged between or adj acent to openings of the closing device holder for discharging the closing devices . The bars are arranged to protrude over the opening area of at least one of the openings . They may be integral to the closing device holder, and they may serve to avoid damaging the opposite vessel wall or tissue when releasing the closing devices from the closing device holder .

[0184] In some embodiments , the medical apparatus comprises a connector to be connected, or to be an integral part of , the retracting device holder, providing an opening for advancing the deploying device and / or the closing device holder into the inner lumen of the retracting device holder .

[0185] In some embodiments , the inner lumen of the connector, or of a cross section thereof , or the opening area of the opening may comprise both sections that delimit a round shape ( at least partially) and sections that delimit an oval shape ( at least partially) .

[0186] In some embodiments , the connector may comprise a seal , membrane , diaphragm or the like acting as a seal by adapting or abutting itsel f to the outer surface of a device inserted through the connector and into the inner lumen of the retracting device holder .

[0187] In some embodiments , the seal , membrane , diaphragm or the like may comprise slits through its material that allow the material to deviate or diverge in order to receive the device and to close the opening again once the device has been removed from the retracting device holder .

[0188] Hence , in some embodiments , the shape of the inner lumen of the connector, or of a cross section thereof , or of the opening area is neither exclusively round nor exclusively oval .

[0189] In some embodiments , the closing device holder is preferably at least partially releasably received in the retracting device holder, preferably translationally in a longitudinal direction of the closing device holder .

[0190] In some embodiments , a method for closing an aperture of a tissue , encompasses the steps :

[0191] - providing a medical apparatus , comprising a retracting device holder, a retracting device with a first arm and a second arm, and a deploying device , wherein the retracting device is positioned at the distal end section of the retracting device holder or attached to the latter ; inserting the deploying device into the lumen of the retracting device holder ;

[0192] - pushing forward both the deploying device and the retracting device holder, comprising the retracting device , up to the aperture until the first arm and the second arm are positioned inside the aperture ;

[0193] - pulling back the deploying device out of the lumen of the retracting device holder ;

[0194] - inserting a closing device holder with closing devices into the lumen of the retracting device holder, whereas the lumen is optionally mostly elliptical or oval shaped, so that the distal opening or openings of the closing device holder, for discharging the closing devices from the closing device holder is / are positioned at the aperture ;

[0195] - pushing out , bringing out or releasing the closing devices for closing the aperture ;

[0196] - optionally closing the aperture by means of the closing devices .

[0197] In some embodiments , a number of arms are provided to act as retracting unit or as part thereof . In some embodiments , some or all of the arms are provided in a line or in a common plane , or in contact with or crossed by a common plane . In some embodiments , the tip of the retracting unit is formed by the tips of the arms that are arranged to not deviate from each other in a lateral direction, preferably at no state while closing the aperture .

[0198] In some particular embodiments , the lengths of the arms are di f ferent from each other . Hence , two or more di f ferent lengths can be provided for the arms , or some of the arms may be moved out from the retracting unit , a common sheath or a casing thereof by a greater length than other ones .

[0199] Hence , in some embodiments , the retracting unit may comprise or consist of a number of arms . Some of the arms may di f fer in lengths or by the extent to which they may be advanced from the inner of the retracting unit to an outside thereof .

[0200] In certain embodiments , all of some of the arms of the retracting unit may be arranged to be advanced into an advanced position and retracted from the advanced position again without being bent or deviated to a lateral side .

[0201] In some embodiments , the arms can be straight or longitudinal components which either cannot be bent during use or will always run in parallel to each other ( or both) .

[0202] In some embodiments there is no form the arms would assume ( due to shape memory features , for example ) other than the form the arms have while not being advanced . The arms may be arranged to be moved out of the casing or an inner of the medical device only if moved together. Hence, they may be interconnected to each other in a way such that they can only be advanced as a group. In other embodiments they can be advanced individually.

[0203] In some embodiments, protectors are provided. They may comprise components made of metal, e.g. wire, and / or components made of plastic, e.g. plastic bands, or respectively consist thereof.

[0204] The protectors may be connected to the arms . They may be arranged to be slid out of the casing or relative to other parts of the medical apparatus, together or only together with the respective arm.

[0205] In some embodiments, one arm is connected to one protector on its upper face, another protector is connected to the lower face thereof.

[0206] In some embodiments, the protectors are arranged to unfold in a direction that is preferably perpendicular (or also perpendicular) to the longitudinal axis of the retracting unit or of the respective arm.

[0207] The protectors may be arranged to unfold in a direction that is preferably perpendicular (or also perpendicular) to the direction of the largest extension of the retracting unit or of the respective arm in a breadth of the retracting unit or its casing.

[0208] In some embodiments, the breadth of the casing or the retracting unit width or depth thereof, preferably rendering the casing or the retracting unit not round but rather flat, rectangular, elliptical or the like in cross section .

[0209] In some embodiments, the closing device comprises or consists of two arms. The may either originate from a common integral material or they may be attached one to the other in an attaching area. They may be glued, welded or attached in any other way to each other.

[0210] In some embodiments, the shape of the closing device is not symmetrical, preferably in no state thereof.

[0211] In some embodiments, the attaching area is inclined to a center line of the closing device.

[0212] For example, the attaching area may be inclined to a line perpendicular to the line of maximum breadth or to a straight line connecting the tips of the arms by an angle between 20° and 70°, preferably between 30° to 60°.

[0213] In some embodiments, the attaching area comprises a through-opening. The through-opening may have a closed circumference, or it may be open toward the circumference by means of an extension of it. The extension may be narrower than the radius of the through-opening itself. Hence, the extension may turn the overall-shape of the through-opening into a key-hole-shape. The extension may be a bottle neck, in one plane, to the main area of the through-opening .

[0214] The wire that the arms of the closing device are made of are preferably made from a flat wire or comprise a flat wire. A flat wire has, in contrast to a round wire, no round cross section. Its cross section is elliptical, rectangular or deviates in another way from a round design . Flat wire allows for higher grip force without surpassing for example nitinol ' s irreversible strain threshold . The closing device is able to hold a ves sel wall with a relevant amount of perivascular tissue and cinch together to create hemostasis and full closure .

[0215] In some embodiments according to the present invention, the medical apparatus for closing an aperture comprises features as disclosed herein, in any arbitrary combination unless not considered technically impos sible by the skilled one . These and other more detailed and speci fic obj ectives and an understanding of the various embodiments of the invention will become apparent from a consideration of the following detailed description of the exemplary embodiments in the view of the drawings .

[0216] The retracting device holder as described herein may in some embodiments be a hollow receptacle or tubing having a lumen for receiving the closing device holder or parts thereof , which in turn may act as the retracting unit , e . g . by its arms .

[0217] In several embodiments , the closing device is comprised by two formerly separate pieces , e . g . a first arm and a second arm . The pieces or the arms may have been attached to one another, e . g . at an attaching area, which may be formed by or comprise a straight or non-curved section .

[0218] The pieces or the arms may be attached to one another via the attaching area by means of one or more rivets .

[0219] When deployed and / or in its undeployed state , the shape of the closing device may not be symmetrical . For example , the first and the second piece or the two arms may be of di f ferent design .

[0220] In particular, the optional asymmetry of the closing device may be achieved by the first arm and the second arm having di f ferent radii in their respective curled or closed position, an optional curved section of the arm that is longer than the optional non-curved section of the arm and / or a shi ft of the attaching area closer to one arm than to the other arm in a plane perpendicular to the longitudinal direction of the attaching area or the non-curved section .

[0221] In some embodiments , the closing device , or each of its pieces or arms , is preferably made from a flat wire or comprise a flat wire . All statements made herein in connection with flat wire also apply to these embodiments .

[0222] In several embodiments , the attaching area, or another section of the closing device may be shaped like a "T" or like a double "T" , e . g . connected at their feet or crossbars .

[0223] Optionally, there are at least two through-openings , optionally provided through the respective cross bars or the respective attaching areas . The through-opening may have a closed circumference and may flush through the respective non-curved sections of the first arm and / or the second arm . These through-openings may be suitable and / or designed to receive rivets and / or may have received such rivets . In case where there is no double "T" design it may be of benefit to have a di f ferently shaped end of the arms opposite to their free , optionally pointed ends , that may be introduced or inserted into or connected with the tip of a pusher, a pusher tube or any other tool provided for extracting or expelling the closing device from the closing device holder . The end might be designed to form a closure fit or a form- fit connection with said tip .

[0224] In some embodiments , the closing device is anchored or attached to the pusher for releasing the closing device from the medical apparatus . The pusher may be pretensioned by the force of a spring . The closing device may be expelled once the spring is allowed to push the pusher forward . In some embodiments , the attached state in which the closing device is optionally connected to the tip or front end of the pusher in a form- fit manner gets automatically lost or released once the tip of the pusher leaves the closing device holder .

[0225] In several embodiments , the tip of the pusher may be designed like a fork having one or at least two prongs bent away from a longitudinal axis and / or the advancing direction of the pusher or other protrusions or proj ections or sections with which the closing device gets stuck so as to form a closure fit ( or form fit ) in said direction .

[0226] In some embodiments , both the connector and the tubing have a patency along their longitudinal direction such that a deploying device , e . g . a trocar, may extend through the lumen of the tubing such that is extends from both ends of the tubing . For example , the tip and the front end section of the deploying device may exit from a front end of the tubing .

[0227] The connector may be positioned at the proximal end of the retracting device holder, which may suitable and / or designed in order to releasably receive the deploying device . In use , the deploying device or tube may protrude from the retracting device holder . Both the deploying device and the deploying device holder may be hollow or have the shape of a, in particular cone , shell in order to receive a, preferably already positioned, guide wire and in order to be guided by it , e . g . , through the aperture into a vessel .

[0228] In several embodiments , the deploying device is manufactured from a more rigid material than the retracting device holder .

[0229] In some embodiments , the handle member comprises a piston, with which the mechanism for releasing the closing members may be controlled, e . g . by means of the thumb of the user . One of several through-openings for receiving a finger or thumb of the user, respectively, may be provided for manipulating the piston .

[0230] The closing device holder, which throughout the entire speci fication may be an assembly of a number of closing device holders , e . g . three in number, may in some embodiments have a flat or thin cross section in one direction of the cross section when compared to the orthogonal direction thereof .

[0231] In several embodiments , at its tip, the retracting unit consists of or comprises lateral arms . In some embodiments the closing device holder emerges directly from the handle member .

[0232] In several embodiments , the closing device holder has one cross section only, or all cross sections have the same area or design .

[0233] In some embodiments , a rocker switch and a slider switch are arranged at the housing or handle .

[0234] In several embodiments , the handle member has connecting devices having the shape of noses or latches which are designed in order to engage with the connecting device of the connector provided at the proximal end thereof and, e . g . , having the shape of a rim . Other securing connecting devices are also encompassed by the present invention at this point . Also , the latches might be provided at the connector instead of the handle member .

[0235] In some embodiments , a number of arms are provided at the tip or free end of the closing device holder . The most lateral arms act as the retracting unit or as part thereof . The medial arms may serve for maintaining a distance between the closing devices and the vessel wall opposite to the aperture .

[0236] In several embodiments , some or all of these arms are provided in a line or in a common plane , or in contact with or crossed by a common plane .

[0237] In some embodiments , the protectors assume di f ferent shapes on the upper and the lower side of the arms . This shape takes the asymmetrical design of the closing devices into account and serves for the protection of the vessel from the corresponding arm of the closing device.

[0238] In some embodiments, the lower (distal) end of the casing is shorter at its rear side than at its top. This may cause the lower arm of the closing member to exit first and curl back first before the upper arm.

[0239] In several embodiments a closing device may assume an uncurled (or not closed) or stretched position inside the closing device holder of the medical apparatus. Thereby, the optionally pointed ends of the arms may be directed downwards and / or towards the opening of the closing device holder.

[0240] In several embodiments, a closing device may be manufactured from one piece, preferably rectangular in cross-section, e.g. from a sheet of Nitinol, which is longitudinally split, preferably partway down its thickness, thus forming the two arms.

[0241] In some embodiments, a closing device may be manufactured from one piece, preferably cylindrical in cross-section, e.g. from a piece of Nitinol, which is longitudinally split, preferably partway down its thickness, thus forming the two arms .

[0242] In several embodiments, the two arms may display different thicknesses, in particular when the longitudinal slit is not positioned in the middle of the cross-section of the piece. In some embodiments, the two arms may, alternatively or additionally, display different thicknesses along their longitudinal extent.

[0243] In several embodiments, the two arms may display rectangular cross-sections, in other embodiments the shape of the cross-sections may be different.

[0244] In some embodiments, the two arms may display crosssections shaped as segments of a circle, in other embodiments the shape of the cross-sections may be different .

[0245] In several embodiments, the two arms may differ in their shapes, dimensions (as width or length or heights or the like) , diameters and / or cross-sections.

[0246] In some embodiments, an attaching area may be one piece or a non-split section of the closing device, respectively .

[0247] In several embodiments, the attaching area may display a number of different cross-sections, widths, lengths, heights and / or diameters in order to be securely holdable in the closing device holder.

[0248] In some embodiments, the attaching area displays a T- shape or double-T-shape .

[0249] In several embodiments, the attaching area displays a cylindrical shape, in certain embodiments having at least two different diameters, i.e. having a broader "head", in order to be securely holdable in the closing device holder . In some embodiments the shape of the closing device may be symmetrical in a curled position, in others it may not .

[0250] In several embodiments , the closing device may be formed as an integral or one-piece item .

[0251] In some embodiments , the radii of the two arms in their respective curled position may be similar or even the same , in others they may not . In embodiments , when the radii are the same , the non-curved section may, thus , be positioned in the middle ( or nearly the middle ) of the circle that is circumscribed by the two arms .

[0252] Using the present invention, it might be possible to substitute closing perforations and suturing them tight with common open surgical methods utili zing a single knot or running surgical sutures . That procedure may be time consuming with related downsides .

[0253] BRIEF DESCRIPTION OF THE DRAWINGS

[0254] FIG . 1 shows the aperture in the patient ' s vessel and the closing with a transverse surgical suture ;

[0255] FIG . 2 shows a closing device in yet another embodiment in a side view;

[0256] FIG . 2A shows the closing device of FIG . 2 in a perspective view; FIG . 2B shows the closing device of FIG . 2A equipped with rivets ;

[0257] FIG . 2C shows the closing device of FIG . 2A in an enlarged view anchored or attached to the pusher for releasing the closing device from the medical apparatus ;

[0258] FIG. 3 shows a connector in a further embodiment penetrated by the deploying device ;

[0259] Fig . 4 shows a handle member of the medical apparatus in a further embodiment ;

[0260] FIG. 4A shows a connector and a handle member with connecting devices in an unconnected state ;

[0261] FIG. 4B shows the connector and the handle member of FIG . 4A in a connected state ;

[0262] FIG. 5 shows parts of the medical apparatus according to the present invention in a further embodiment in a side view;

[0263] FIG. 5A shows the parts of the medical apparatus of FIG . 5 in a perspective view .

[0264] FIG. 6 shows the proximal part of the handle member in a perspective view with the rocker switch in a first position;

[0265] FIG. 6A shows the distal part of the handle member of

[0266] FIG . 6 with its rocker switch in a second position; FIG . 6B shows the uncovered distal part of the handle member of FIG . 6A;

[0267] FIG . 7 shows part of the handle member in an enlarged view with a slider switch in a first position;

[0268] FIG . 7A shows the part of the handle member of FIG . 7 with its slider switch in a second position;

[0269] FIG . 8 shows a closing device in yet another embodiment in a perspective view and in an uncurled or stretched position;

[0270] FIG . 8A shows the closing device of FIG . 8 in a curled position;

[0271] FIG . 9 shows a closing device in yet another embodiment in a perspective view and in an uncurled or stretched position;

[0272] FIG . 9A shows the closing device of FIG . 9 in a curled position; and

[0273] FIG . 10 shows the medical apparatus in yet another embodiment .

[0274] DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS OF THE INVENTION

[0275] Speci fic embodiments of the present disclosure are directed to a vascular closing apparatus and a method for closing an aperture in a tissue such as a vascular closing device comprising a tissue retracting unit and an aperture closing member .

[0276] Tissue Retraction

[0277] In one aspect of the present invention, a retracting unit is provided to retract two opposing sites of a tissue aperture . After the two arms , sides or the like are deployed at opposite sides in the aperture to close , the distance between the arms , sides and so on is increased in order to retract the opposing sides , changing the shape of the tissue opening ( aperture ) to a slit , in which the two long straight sides of the aperture are approximated in preparation for the closure .

[0278] It will be appreciated by those skilled in the art , that the closure of the vessel as described herein follows the principle of surgical vascular closure techniques to prevent a narrowing or stenosis of the vessel to be treated . The retracting device is preparing the aperture in the tissue to become a transverse slit orthogonal to the vessel ' s long axis , comparable with an open surgical transverse suture-line . A circular retraction of the aperture , like in an open surgical cross-stich procedure or a longitudinal suture-line is prevented to avoid stenosis of the vessel to be treated, see FIG . 27 .

[0279] Aperture Closure

[0280] Another aspect of the present invention relates to a closing member to close a tissue aperture that was prepared with the retractor unit . It should be recogni zed that the retracting unit and the closing member might be used for general tissue repair, not j ust limited to vascular repair . It will be appreciated throughout the following description that the closing device of the medical apparatus can be formed of any biocompatible and / or bio-absorbable material, including, for example, Titanium (and Titanium alloys) , Nitinol, stainless steel, polymeric materials (synthetic and / or natural) , ceramic, etc. It will also be apparent from the description that the closing device has preferably the shape of a needle in the form of a loop or circle formed of a deformable shape memory alloy, e.g., Nitinol. As a general overview, the closing device of the present invention undergoes two positions of deformation: a first position in a compressed, straight configuration in which the closing device is captured in a closing device holder and deployed in the aperture and a second expanded round configuration in which the closing device approximates the aperture ends and closes the perforation in the tissue .

[0281] After the aperture in the tissue was prepared by the retracting device in order to form a slit, the two long sides of the slit are connected by the closing device to close the tissue opening.

[0282] FIG. 27 is a surgeon view of the aperture 302 of a patient's vessel 301, showing the open surgical closure of the aperture 302 with a suture. The aperture 302 in the patient's vessel 301 is closed in a straight line orthogonal to the vessel's long axis, with a running or interrupted suture 2600 to avoid a stenosis of the patient's vessel. This principle of closing an aperture in a patient vessel is of particular importance and is realized in this invention as shown in FIG. 10 - FIG. 12 and FIG. 22 - FIG. 26 which illustrate an exemplary method of operating the medical apparatus. It will be appreciated by those skilled in the art that although the description is made to preferred embodiments, the disclosure and description in many respects, is only illustrative and not restrictive, susceptible to various modifications and alternative forms. Changes may be made in details, particularly in matters of shape, size, material and arrangement of parts without exceeding the scope of the invention. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents and alternatives.

[0283] Accordingly, the scope of the invention is defined in the claims .

[0284] FIG. 2 shows a closing device 600 in yet another embodiment in a side view. It comprises two arms 604a and 604b, each of which carries an - optionally pointed - end 603. The closing device 600 is shown in the curled position, a position the closing device 600 assumes while keeping the margins of the aperture together (i.e., after having been released from the medical apparatus) .

[0285] In the exemplary embodiment of FIG. 2, the closing device 600 is comprised by two formerly separate pieces, one formed by arm 604a, the other one by arm 604b. If formed by the arms 604a, 604b produced independently from each other, the arms 604a and 604b may be attached one to the other. This may happen by means of an attaching area 609, which may be formed by or comprise a straight or noncurved section 607. That section 607 is shown in FIG. 2 as an upright, vertical section. Section 607 may assume, once the closing device 600 has been ejected from the medical apparatus and has assumed the shape depicted in FIG. 2, a position within the tissue of the patient like the one shown in FIG. 2, i.e. with the section 607 extending vertically to the longitudinal axis of the vessel where it comprises the aperture 302.

[0286] The arms 604a and 604b may be attached one to the other via the attaching area 609 by means of rivets. Such a riveted state may be seen in FIG. 2B, in contrast to FIG. 2 and FIG. 2B.

[0287] As can be seen from FIG. 2 (please also refer to FIG. 2A and 2B) , the shape of the closing device 600 may not be symmetrical .

[0288] In the particular example of FIG. 2, the optional asymmetry of the closing device 600 is achieved by the first arm 604a and the second arm 604b having different radii in their respective curled position, a non-curved section 607 of the arm 604b that is longer than the noncurved section 607 of the arm 604a and / or a shift of the attaching area 609 closer to one arm 604b than to the other arm 604a in a plane perpendicular to the longitudinal direction (the vertical extension in FIG. 2) of the attaching area 609 or the non-curved section 607.

[0289] This asymmetry may be helpful when releasing the closing device 600 from the medical apparatus, e.g. using an optional pusher such as the pusher tube 808 as disclosed herein. The asymmetry serves in particular to compensate for the different angular sections when the medical apparatus is inserted under a certain angle smaller or remarkably smaller than 90° into an aperture 302, e.g., of a vessel (see e.g. FIG. 49A) . The medical apparatus may be inserted in, e.g., a 45° angle against the tissue surface (of advantage to the surgeon, e.g. as it facilitates introducing parts of the medical apparatus into the vessel through the aperture and, e.g., along the guide wire) .

[0290] The closing device 600 or each of its arms 604a and 604b is preferably made of or are preferably made from a flat wire or comprise a flat wire. All statements made herein in connection with flat wire also apply to this embodiment .

[0291] FIG. 2A shows the closing device 600 of FIG. 2 in a perspective view (from the right side) , or rotated about the vertical by about 45° compared to the view shown in FIG. 2.

[0292] As can be seen from FIG. 2A, the non-curved section 607, which could also be referred to as the attaching area 609, may optionally be shaped like a double "T", connected at their feet or cross-bars.

[0293] Moreover, there are optionally at least two through- openings 613, optionally provided through the cross bars, that may have a closed circumference and may flush through the respective non-curved sections of the first arm 604a and the second arm 604b. These through-openings may be suitable and / or designed to receive rivets 615 (see FIG. 2B) .

[0294] FIG. 2B shows the closing device 600 of FIG. 2A equipped with, exemplarily two, rivets 615 that attach the first arm 604a to the second arm 604b. The usage of rivets 615 , e . g . instead of using welding techniques , for attaching the first arm 604a to the second arm 604b is advantageously cheaper in production .

[0295] Moreover, the attachment force between the two arms 604a, 604b may be much stronger when compared to having them welded to each other .

[0296] In case there is no double "T" design it may be of benefit to have another designed end of the arms 604a, 604b opposite to the free , optionally pointed ends , that may be introduced into or connected with the tip of a pusher, a pusher tube or any other tool provided for extracting or expelling the closing device 600 from the closing device holder 802 . The end might be designed to form a form- fit connection with said tip . An example of a form- fit connection is shown in and discussed with respect to Fig . 2C .

[0297] FIG . 2C shows one end of the first arm 604a and the second arm 604b, respectively, as shown in FIG . 2 , the end comprising the non-curved section 607 of each arm 604a, 604b . An indication to the attaching area 609 provided between the two non-curved sections 607 .

[0298] The rivets 615 ( see FIG . 2B ) , which are optional anyway, were omitted due to reasons of clarity .

[0299] FIG . 2C shows the closing device 600 of FIG . 2A anchored or attached to the pusher for releasing the closing device 600 from the medical apparatus . The pusher may be the pusher tube 808 as disclosed herein or any other pusher . The attached state in which the closing device 600 is connected to the tip or front end of the pusher in a form- fit manner gets automatically lost or released once the tip of the pusher leaves the closing device holder 802 , as can be derived from in FIG . 2C .

[0300] In particular, as can be seen from FIG . 2C, the tip of the pusher 808 may be designed like a fork having two prongs 808a, 808b bent away from a longitudinal axi s and / or the advancing direction L of the pusher tube 808 , or to have di f ferently protrusions or proj ections or sections with which the T-shaped part of the closing device 600 gets stuck so as to form a closure fit ( or form fit ) in said direction . Since the narrow section of the T-shaped end of the closing device 600 , having the T- shaped section or not , is only inserted into the void or receptacle formed at the pusher ' s tip, e . g . by the forklike design, optionally without being connected further, the closing device 600 will come of f the tip once the latter has emerged from the closing device holder 802 that, until this moment , has comprised also the noncurved section 607 of each arm 604a, 604b tip of the closing device holder 802 in its lumen . Hence , once advanced out of said lumen, the closure fit in a radial direction ensured by the inner surface of the closing device holder 802 gets lost . Consequently, the longitudinal form fit will get lost as well , and closing device 600 will come of f the tip of the pusher tube 808 or released from the closure fit with the latter .

[0301] I f provided, the prongs 808a, 808b may in any embodiment have a slanted proximal edge to avoid that the closure device 600 gets stuck and to facilitate the release of the closure device 600 .

[0302] FIG . 3 shows a connector 500 in a further embodiment . It is integral with or connected to a first tubing, herein also referred to as retracting device holder 102 without being limited thereto. As can be seen in FIG. 3 both the connector 500 and the tubing 102 have a patency along their longitudinal direction such that a deploying device 103, e.g. a trocar, may extend through the lumen of the tubing 102 such that is extends from both ends of the tubing 102. As can be seen in FIG. 3, the tip and the front end section of the deploying device 103 exits from a front end 102a of the tubing 102.

[0303] All statements made herein with regard to the connector 500, the retracting device holder 102 and / or the deploying device 103 may also apply to the connector 500, the retracting device holder 102 and / or the deploying device 103 of this embodiment.

[0304] The connector 500 is positioned at the proximal end of the retracting device holder 102, which is suitable and / or designed in order to releasably receive the deploying device 103. In use, the deploying device 103 or tube protrudes from the retracting device holder 102. Both the deploying device 103 and the deploying device holder 102 may be hollow or have the shape of a, in particular cone, shell in order to receive a, preferably already positioned, guide wire and in order to be guided by it, e.g., through the aperture 302 into a vessel.

[0305] In the example of FIG. 3, the deploying device 103 tapers towards its distal end (on the left in FIG. 3) , this may be different in other embodiments.

[0306] Preferably, the deploying device 103 is manufactured from a more rigid material than the retracting device holder 102. In contrast to other embodiments, the retracting device holder 102 shows no retracting devices such as arms as it may show in other embodiments, not illustrated herein in figures .

[0307] The connector 500, the tubing 102 and the deploying device 103 may form part of the set according to the present invention.

[0308] FIG. 4 shows a handle member 900 of the medical apparatus in a further embodiment.

[0309] All statements made herein concerning the design and use of the handle member 900 and at least some of its mechanisms for pushing and advancing components, e.g., the retracting device, the closing devices 600, and more may also apply in this embodiment.

[0310] In contrast to preceding figures concerning the handle member 900, the exemplary embodiment shown in FIG. 4 comprises a piston 921, with which the mechanism for releasing the closing members 600 may be controlled, e.g. by means of the thumb of the user. One of more (here: three) through-openings 925 for receiving a finger or thumb, respectively, may be provided for manipulating the piston 921. This exemplary design may be more ergonomic and, therefore, more comfortable for the user.

[0311] The closing device holder 802, which throughout the entire specification may be an assembly of a number of closing device holders 802, e.g. three in number, is shown to have a flat cross section. At its tip, the retracting unit 100 consisting of lateral arms 101a and 101a is shown . In the embodiment of FIG . 4 , the closing device holder 802 emerges directly from the handle member 900 . In the embodiment of FIG . 4 , the closing device holder 802 has optionally one cross section only .

[0312] Moreover, the example of FIG . 4 shows a rocker switch 919 and a slider switch 923 , which are described in more detail below .

[0313] FIG . 4A shows a connector 500 and a handle member 900 of an embodiment with connecting devices 500a, 900a for connecting the connector 500 to the handle member 900 . In FIG . 4A, connector 500 and a handle member 900 are not connected to each other (unconnected or disconnected state ) .

[0314] In the example of FIG . 4A the handle member 900 exemplarily shows connecting devices 900a having the shape of noses or latches which are designed in order to engage with the connecting device 500a of the connector 500 that may be a hemostasis valve , for avoiding blood leakage once the medical apparatus or a part of the medical apparatus has been introduced into the body of a patient , provided at the proximal end thereof and having the shape of a rim ( see FIG . 3B ) .

[0315] Other securing connecting devices are also encompas sed by the present invention at this point . Also , the latches might be provided at the connector 500 instead of the handle member 900 .

[0316] Hence , the connecting devices 500a, 900a may optionally be provided to allow connecting the connector 500 to the handle member 900 , preferably in a releasable way . FIG . 4B shows the connector 500 and the handle member 900 of FIG . 4A connected to each other by the connecting devices ( connected state ) .

[0317] FIG . 5 shows parts of the closing device holder 802 of the medical apparatus according a further embodiment in a side view . Parts of the medical apparatus would be introduced into a lumen of a vessel through the aperture 302 (not shown) to be closed, the upper vessel wall 301 is schematically simpli fied indicated by a line . The closing devices 600 , represented by their arms 604a and 604b are partly released .

[0318] A number of arms 101a, 101b ( four in this exemplary embodiment , see FIG . 5A, a higher or smaller number of arms could be provided in other embodiments ) are provided at the tip or free end of the closing device holder 802 . The lateral arms 101a act as retracting unit 100 or as part thereof . The medial arms 101b serve for maintaining a distance between the closing devices 600 and the vessel wall opposite to the aperture 302 .

[0319] Upon advancing the arms 101a into the aperture 302 they retract the aperture 302 into a slit as described herein . In FIG . 5 , the arms 101a, 101b are shown not to be covered by the sheaths or the casing 117 of the closing device holder 802 which also comprises the retracting unit 100 formed by the arms 101a .

[0320] In the present embodiment , some or all of the arms 101a, 101b are provided in a line or in a common plane , or in contact with or crossed by a common plane . This way, they may allow the aperture 302 to expand into a slit shape while the arms 101a, 101b themselves may still be easily retracted from the slit as the retracting unit 100, here consisting of the two arms 101a, remains quite flat or knife-shaped.

[0321] In some particular embodiments, the lengths of the arms 101a, 101b are different from each other, in particular as described herein. Moreover, the statement made herein to arms 101a of the retracting unit 100 may also apply in this embodiment.

[0322] FIG. 5 also features some optional protectors lOld each of which is deployed in vicinity of one arm 101b, respectively. In some embodiments, protectors lOld are connected to an arm 101a or 101b, respectively, wherein one protector lOld or more protectors lOld can be connected to a particular, single arm 101a or 101b. For example, one arm 101a, 101b may be connected to one protector lOld on its upper face, another protector lOld on its lower face as it may be the case in the example of other embodiments) .

[0323] All the statements made herein with regard to protectors lOld may also apply in this embodiment.

[0324] In the example of FIG. 5, the protectors assume different shapes on the upper and the lower side of the arms 101a and / or 101b. This shape takes the asymmetrical design of the closing devices 600 (see FIG. 2, FIG. 2A, FIG. 2B for reference) into account and serves for the protection of the vessel from the corresponding arm 604a, 604b of the closing device 600. Hence, an arm (here: 604a) of the closing device 600 that reaches out far more than another arm (here: 604b) in its deployed but not yet closed state as the one shown in FIG. 5 is surrounded or covered (in one plane such as the drawing plane of FIG. 5 or in a plane parallel to that) by a protector lOld that covers more area as can be seen in FIG. 5.

[0325] In the example of FIG. 5, the lower (distal) end of the casing 117 is shorter at its rear side (in FIG. 5 right) than at its top (in FIG. 5 left) . The slope of the rim of the casing may be defined by the angle a with respect to a cross direction of the casing 117 or the closing device holder 802. This design follows the differently shaped protectors lOld on the upper versus the lower side of the arms 101a and 101b in order to allow the protector lOld at the rear side of the closing device holder 802 to exit from the closing device holder 802 at a section proximal to where the opposite protector lOld at the top or front side of the closing device holder 802 exits from the latter when deployed.

[0326] FIG. 5 further shows, that the longitudinal axis of the closing device holder 805 is not placed vertical in the vessel (represented by the vessel wall 301) , but rather under an angle y , when referred to the top of the closing device holder 805, or under an angle p, when referred to the rear side of the closing device holder 805, respectively. Normally, p and y will sum up to approx. 180°, assuming a flat vessel wall. Hence, the radii and the length of the first arm 604a of the closing device 600 may be chosen in order to bridge angle p, which may exemplarily be between 0° and 50°, the radii and the length of the second arm 604b may be chosen in order to bridge angle y, which may exemplarily be between 120° and 160°, preferably between 125° and 135°. FIG . 5A shows the medical apparatus of FIG . 5 in a perspective view . In order to avoid repetitions , reference is made to the description of the preceding figures .

[0327] FIG . 6 shows the proximal part of the handle member 900 in a perspective view with its optional rocker switch 919 in a first position . In this position, the mechanism provided in the handle member 900 prevents the piston 921 from being moved relative to the casing of the handle member 900 .

[0328] FIG . 6A shows the handle member 900 of FIG . 6 with its rocker switch 919 in a second position . In this pos ition, the piston 921 may be pressed or moved in any other way in order to release the closing devices 600 (not shown) and to close the aperture 302 in or of the vessel therewith . This is represented by the block arrow next to the piston 921 .

[0329] FIG. 6B shows the handle member 900 of FIG . 6 . In contrast to preceding figures concerning the handle member 900 , the piston 921 and the outer shell or cover is removed for the sake of visibility .

[0330] As can be seen, the mechanism for releasing the closing members 600 can comprise one or more springs 811 . The mechanism is provided for an auto-deployment of the closing devices 600 and which can be switched to the second position in order to connect the closing devices 600 to the spring mechanism 811 which allows the pusher 808 or its tip to advance and expose the release prongs 808a and 808b and to release the closing device 600 . Hence , each pusher 808 may be pre-tensioned by the force of one or more of the springs 811 . The closing device 600 may be expelled once the spring 811 or the spring mechanism is allowed to push the pusher 808 forward .

[0331] FIG . 7 shows part of the handle member 900 in an enlarged view . The handle member 900 comprises a slider switch 923 , the mechanism of which may engage or disengage the closing devices 600 to or from the spring ( s ) ; this may display similarities to a drill or electric screwdriver to reverse rotation direction .

[0332] In the example of FIG . 7 the slider switch 923 is in a first position .

[0333] In this position, the closing devices 600 are rigidly connected to the closing device holder 802 or parts thereof . This may advantageously allow re-sheathing the closing devices 600 , e . g . , in the event of a bailout .

[0334] FIG. 7A shows the part of the handle member 900 of FIG . 7 with its slider switch 923 in a second position .

[0335] In the second position of the slider switch 923 the closing devices 600 are attached to the spring mechanism provided in the closing device holder 802 , in order to be released at the desired place , e . g . , in order to close the aperture 302 of the vessel 301 .

[0336] Preferably, the slider switch 923 remains in its first position until the user is ready for final pullback or auto-deployment of the closing devices 600 and is then switched into its second position in order to attach the closing devices 600 to the spring mechanism 811 to have them finally deployed in or at the desired positions.

[0337] FIG. 8 shows a closing device 600 in yet another embodiment in a perspective view and in an uncurled or stretched position. It comprises two arms 604a and 604b, each of which has an - optionally pointed - end 603. The position of the closing device 600 shown in FIG. 8 shows the position the closing device 600 may assume inside the closing device holder 802 of the medical apparatus (not shown) .

[0338] In the exemplary embodiment of FIG. 8, the closing device 600 is manufactured from one piece, preferably rectangular in cross-section, e.g. from a sheet of Nitinol, which is longitudinally split, preferably partway down its thickness, thus forming the two arms 604a and 604b.

[0339] In other embodiments, the two arms 604a and 604b may display different thicknesses, in particular when the longitudinal slit is not positioned in the middle of the cross-section of the piece.

[0340] Alternatively or additionally, the two arms 604a and 604b may display different thicknesses along their longitudinal extent.

[0341] Therefore, an attaching area 609 is in this embodiment one piece or a non-split section of the closing device 600, respectively. It may display a number of different cross-sections, widths, lengths, heights and / or diameters in order to be securely holdable in the closing device holder 802. The design shown in FIG. 8 has an attaching area 609 in a T-shape or double-T-shape . This, however, is not limiting.

[0342] As can be seen from FIG. 8 (please also refer to

[0343] FIG. 8A) , although the shape of the closing device 600 may be symmetrical, in this particular embodiment it is not as there is an optional difference in the length and also an optional difference in the shape of the two arms 604a and 604b (see how their ends 603 are differently sharpened) . Reference is made to the purposes and advantages of an asymmetric design made herein (e.g. with regard to FIG. 2) .

[0344] In the example of FIG. 8, the closing device 600 or each of its arms 604a and 604b preferably has, at least in part, a rectangular cross-section. This is not to be understood as limiting. Other shapes of the crosssections are also possible (e.g. see FIG. 9) and comprised by the present invention.

[0345] As can be derived from FIG. 8, the closing device 600 may be an integral device, made up from one piece of material only. Hence, in this embodiment it is not comprised by more than one piece, i.e. two or more, that had to be attached to each other by, e. g. welding, gluing, and the like .

[0346] It is noted that not only the closing device 600 of FIG. 8 may be formed as an integral or one-piece item. Every other closing device disclosed or mentioned herein may also be, irrespective of any other feature of it.

[0347] FIG. 8A shows the closing device 600 of FIG. 8 in a perspective view and in a curled position. The closing device 600 is shown in the position that it assumes when keeping the margins of the aperture together (i.e., after having been released from the medical apparatus) .

[0348] In the curled position, the attaching area 609 may be formed by, or comprise, a straight or non-curved section 607. The section 607 may assume, once the closing device 600 has been ejected from the medical apparatus and has assumed the shape depicted in FIG. 8A, a position within the tissue of the patient, i.e. with the section 607 extending vertically to the longitudinal axis of the vessel where it comprises the aperture 302.

[0349] In the particular example of FIG. 2, the optional asymmetry of the closing device 600 is achieved by the first arm 604a and the second arm 604b having different lengths and shapes. In contrast to the embodiment of FIG. 2 the radii of the two arms 604a and 604b in their respective curled position may be similar or even the same in this embodiment. Thus, the non-curved section 607 is positioned in the middle (or nearly the middle) of the circle that is circumscribed by the arm 604b and the arm 604a.

[0350] FIG. 9 shows a closing device 600 in yet another embodiment in a perspective view and in an uncurled or stretched position.

[0351] Reference is made to the description regarding FIG. 8 and FIG. 8A. Only the differences to this embodiment are pointed out in order to avoid repetition.

[0352] In the exemplary embodiment of FIG. 9, the closing device

[0353] 600 is manufactured from one piece, preferably cylindrical in cross-section, e.g. from a piece of Nitinol, which is longitudinally split, preferably partway down its thickness, thus forming the two arms 604a and 604b, each of which carries an - optionally pointed - end 603.

[0354] This results in different cross-sections in comparison to FIG. 8. The attaching area 609 displays a cylindrical shape with (at least) two different circular crosssections, whereas the two arms 604a and 604b preferably display a cross-section shaped like the segment of a circle. This is not to be understood as limiting. Other shapes of the cross-sections are also possible and comprised by the present invention, e.g. oval ones.

[0355] Therefore, the attaching area 609 may in this embodiment display a number of different cross-sections, widths, lengths, heights and / or diameters in order to be securely holdable in the closing device holder 802. The design shown in FIG. 9 has an attaching area 609 with a broader "head". This, however, is not limiting.

[0356] FIG. 9A shows the closing device 600 of FIG. 9 in a perspective view and in a curled position. The closing device 600 is shown in the position it assumes while keeping the margins of the aperture together (i.e., after having been released from the medical apparatus) .

[0357] Reference is made to the descriptions above in order to avoid repetition.

[0358] FIG. 10 shows the medical apparatus for closing an aperture 302, an incision, a puncture, a passage through tissue, a fistula and / or a communication with a blood vessel or other body lumen (short: aperture) in yet another embodiment.

[0359] The medical apparatus comprises one, but preferably no more than one, closing device holder 802 comprising, or prepared to comprise a closing device 600 in particular exactly one, or more than one.

[0360] The closing device 600, is releasably received within the closing device holder 802, may be designed as disclosed herein .

[0361] A pusher or a pusher tube 808 may be provided to push the closing device 600 out of the closing device holder 802 once the surgeon or user decides to have the medical apparatus or its tip correctly placed in order to actually close the aperture, fistula or the like by releasing the closing device 600 from the closing device holder 802.

[0362] In order to release the closing device 600 the pusher or pusher tube 808, which optionally is comprised within the device holder 802 as well, is forwarded until, by doing so, the closing device 600 is expelled from or pushed (e. g. in one move or stepwise) out of the opening of the closing device holder 802 at its distal end 804.

[0363] In case the closing device 600 comprises shape memory features, once released, the closing device 600 assumes or regains its originally intended shape while grabbing and penetrating the tissue, thus closing the aperture 302, the fistula, the anal fistula or the like. Also, once released, the closing device 600 may separate from the closing device holder 802, e. g., from the connector, mechanisms , structure or the like releasably connecting the closing device 600 to the pusher 808 , the closing device holder 802 or any other structure , or parts thereof .

[0364] As stated supra, a mechanism for releasing the clos ing device 600 can be provided . The mechanism may comprise one or more springs (not shown in FIG . 10 ) . The mechanism may be provided for an auto-deployment of the closing device 600 and can be switched to the second position in order to connect the closing device 600 to the spring mechanism which allows the pusher 808 or its tip to advance and expose the optionally provided release prongs 808a and 808b and to release the closing device 600 . Hence , the pusher 808 may be pre-tensioned by the force of one or more of the springs (not shown) . Alternatively, the pusher 808 may be provided to be manually advanced . In some embodiments , the closing device 600 may be expelled once the spring 811 or the spring mechanism is allowed to push the pusher 808 forward .

[0365] As can be seen in FIG . 10 , the medical device may comprise a handle 900 . The handle , may, as in the example of FIG . 10 , be arranged at a circumference of the closing device holder 802 . The handle 900 may be divided into a first part 900a and a second part 900b .

[0366] In the embodiment of FIG . 10 , the first part 900a and the second part 900b may be moved towards each other, for example along a straight line , hence reducing the distance between them . Since between the pusher or pusher 808 and the second part 900b there is a form fit and / or a force closure provided, moving the second part 900b manually or otherwise will advance or retract the pusher or pusher tube 808 as well .

[0367] In FIG . 10 , the first part 900a is optionally in a form fit and / or a force closure with the closing device holder 802 and / or not movable relative to the latter .

[0368] Optionally, any type of a lock, a clamp or the like may be provided between the second part 900b and the first part 900a or the closing device holder 802 in order prevent the second part 900a and / or the pusher or pusher tube 808 from being unintentionally advanced . The clamp or the like may be manually removed by the surgeon or user .

[0369] As can be seen from FIG . 10 and as stated supra, a retracting unit to come into contact with opposite sides of the aperture may or may not be comprised in the medical device and is not in the embodiment shown in FIG . 10 .

[0370] LIST OF REFERENCE NUMERALS

[0371] 100 retracting unit

[0372] 101a arm

[0373] 101b arm l O ld protector

[0374] 102 retracting device holder, tubing

[0375] 102a front end of tubing 102

[0376] 103 deploying device

[0377] 117 casing

[0378] 301 vessel , vessel wall , tissue

[0379] 302 (vessel ) aperture , slit opening, aperture opening

[0380] 500 connector ; hemostasis valve

[0381] 500a connecting device

[0382] 503 flush line , sheath flush line

[0383] 600 closing device

[0384] 603 distal end, pointed end, closing member, tip of the closing device , end of the closing device

[0385] 604 arm

[0386] 604a arm

[0387] 604b arm

[0388] 607 non-curved or straight section

[0389] 609 attaching area

[0390] 613 through-opening

[0391] 615 rivet

[0392] 800 closing member

[0393] 802 closing device holder

[0394] 803 channel , lateral channel 808 pusher tube

[0395] 808a prong

[0396] 808b prong

[0397] 811 spring or spring mechanism

[0398] 900 handle member

[0399] 900a connecting device

[0400] 902 first slider

[0401] 919 rocker switch

[0402] 921 piston

[0403] 923 slider switch

[0404] 925 through-opening for finger or thumb

[0405] 2600 suture

[0406] B breadth

[0407] L longitudinal axis

[0408] DR cross section diameter

[0409] DN main axis length

[0410] R radial direction

[0411] W width a angle of the slope of casing p , Y angle between longitudinal axis and vessel wall

Claims

CLAIMS1. A medical apparatus for closing an aperture (302) , an incision, a puncture, a passage through tissue and / or a communication with a blood vessel or other body lumen (short: aperture) of a tissue (301) of a patient, the medical apparatus comprising a closing device holder (802) , for releasably receiving one or more closing devices (600) ; and a retracting unit (100) to come into contact with opposite sides of the aperture (302) and for retracting them and / or for spreading the aperture (302) causing it to change its shape into a slit or a slit-like or a more slit-like aperture (302) or to spread or to augment the dimension or diameter of the aperture (302) in at least one or in exactly one dimension of the aperture ( 302 ) .

2. The medical apparatus according to claim 1, the retracting unit (100) comprising: at least one retracting device holder (102) ; and at least one retracting device, preferably at least partially received in the retracting device holder (102) ,wherein the retracting device is preferably at least partially releasably received in the retracting device holder (102) ; wherein the retracting device is preferably arranged in a moveable or slidable manner with respect to the retracting device holder (102) . The medical apparatus according to any one of the preceding claims, comprising at least one closing device (600) , wherein the closing device (600) may assume an uncurled (or not closed) or stretched position inside the closing device holder (802) , wherein the, optionally pointed, ends of the arms of the closing device (600) are directed downwards and / or towards the opening of the closing device holder (802) . The medical apparatus according to any one of the preceding claims, comprising at least one closing device (600) manufactured from one piece, preferably rectangular in cross-section, e.g. from a sheet of Nitinol, which is longitudinally split, preferably partway down its thickness, thus forming two arms (604a, 604b) . The medical apparatus according to any one of the preceding claims, comprising at least one closing device (600) comprising two arms (604a, 604b) displaying different thicknesses, in particular when the longitudinal slit is not positioned in the middle of the cross-section or depth of the piece. The medical apparatus according to any one of the preceding claims, wherein the two arms (604a, 604b)display different thicknesses along their longitudinal extent. The medical apparatus according to any one of the preceding claims, wherein the two arms (604a, 604b) display rectangular cross-sections. The medical apparatus according to any one of the preceding claims, wherein the two arms (604a, 604b) display cross-sections shaped as segments of a circle, at least once deployed. The medical apparatus according to any one of the preceding claims, wherein the two arms (604a, 604b) differ in their shapes, dimensions, diameters and / or cross-sections . The medical apparatus according to any one of the preceding claims, wherein an attaching area (609) may be one piece or a non-split section of the closing device, respectively. The medical apparatus according to any one of the preceding claims, wherein the attaching area (609) display two, three, four or more different crosssections, widths, lengths, heights and / or diameters. The medical apparatus according to any one of the preceding claims, wherein the attaching area (609) displays a T-shape or double-T-shape . The medical apparatus according to any one of the preceding claims, wherein the attaching area (609) displays a cylindrical shape, in certain embodiments having at least two different diameters, i.e. havinga broader "head", in order to be securely holdable in the closing device holder. The medical apparatus according to any one of the preceding claims, wherein the shape of the closing device (600) is symmetrical in a curled position. The medical apparatus according to any one of the preceding claims, wherein the shape of the closing device (600) is not symmetrical in a curled position . The medical apparatus according to any one of the preceding claims, wherein the closing device (600) is formed as an integral or one-piece item. The medical apparatus according to any one of the preceding claims, wherein the radii of the two arms (604a, 604b) in their respective curled position may be similar or even the same, in others they may not. The medical apparatus according to any one of the preceding claims, wherein the radii are the same, and wherein the non-curved section is positioned in the middle (or nearly the middle) of the circle that is circumscribed by the two arms (604a, 604b) . method for closing an aperture (302) of a tissue, encompassing the steps: providing a medical apparatus according to any one of the claims 1 to 18, comprising a retracting device holder (102) , a retracting device with a first arm (135) and a second arm (137) or aclosing device holder (802) serving as a retracting device, and a deploying device (103) , ; inserting the deploying device (103) into the lumen of the retracting device holder (102) . method according to claim 19, further encompassing the steps: pushing forward both the deploying device (103) and the retracting device holder (102) up to the aperture (302) until at least parts of the deploying device (103) into the lumen of the retracting device holder (102) are positioned inside the aperture (302) or in the vessel (301) ; pulling the deploying device (103) back and out of the lumen of the retracting device holder (102) ; inserting the closing device holder (802) having closing devices (600) into the, preferably mostly elliptical or oval shaped, lumen of the retracting device holder (102) , so that the distal opening or openings of the closing device holder (802) for discharging the closing devices (600) from the closing device holder (802) is / are positioned at the aperture (302) ; pushing out, releasing or bringing out the closing devices (600) from the closing device holder (802) for closing the aperture (302) . method for closing an aperture (302) of a tissue, encompassing the steps:providing a medical apparatus according to any one of the claims 1 to 19; closing the aperture (302) by means of the medical apparatus. A closing device (600) for closing an aperture(302) , an incision, a puncture, a passage through tissue and / or a communication with a blood vessel or other body lumen (short: aperture) of a tissue (301) of a patient, the closing device (600) comprising two, at least two or more arms (604, 604a, 600b) for penetrating the tissue (301) . A set consisting of or comprising a medical apparatus according to any one of the claims 1 to 19; wherein the medical apparatus comprises a closing device holder (802) as described herein; a retracting device holder (102) as described herein; and a deploying device (103) as described herein; and optionally further a guide wire (1000) .

Images