Medical devices and methods for closing tissue holes - Patents.com

Abstract

The present invention relates to a medical device for closing a hole (302), incision, puncture, passageway through tissue, and / or communication with a blood vessel or other body lumen (hole for short) in a patient's tissue (301), comprising a closure device holder (802) for releasably receiving one or more closure devices (600), and a retraction unit (100) for contacting and retracting opposite sides of the hole (302) and / or widening the hole (302) to form a slit or slit-like or more slit-like shape, or for enlarging or increasing the size or diameter of the hole (302) in at least one or exactly one dimension of the hole (302).

Description

[Technical field]

[0001] The present invention relates to a medical device for closing a hole or opening according to the preamble of claim 1 and to a method for closing a hole according to the preamble of claim 25. The present invention also relates to a closure device according to claim 26.

[0002] The present invention relates generally to medical apparatus (briefly, apparatus) and methods for engaging and / or closing openings through tissue, and more particularly to closing holes in blood vessels or other body cavities as an alternative to suturing, and more particularly to closure devices and corresponding methods of use that have application for closing openings in body organ or vessel walls, particularly following an invasive procedure within a patient's body. [Background technology]

[0003] There are several interventional procedures that are commonly performed by puncturing and inserting a hollow needle into a blood vessel or other body organ, after which a guidewire may be advanced through the lumen of the needle into the patient's blood vessel or other organ. The guidewire may be advanced through the needle, the needle may be removed, and an introducer casing may be advanced over the guidewire into the blood vessel or other body organ (Seldinger technique). Such casings are generally flexible tubes with thin walls and diameters that fit the needs of the treatment system utilized, ranging up to about 30F or more. The proximal end of the casing is held outside the patient's skin and is commonly utilized with a hemostatic valve to prevent blood flow out of the blood vessel through the casing. A catheter or other device may then be advanced through the lumen of the introducer casing and over the guidewire into position to perform the medical procedure. Punctures are utilized for many reasons, including but not limited to diagnostic cardiovascular surgery, coronary and peripheral angioplasty or stenting, cardiac valve replacement implantation and repair, thoracoscopic, laparoscopic or endoscopic surgery, etc. All of these procedures require making a puncture in the wall of a body organ or blood vessel to be used to treat the patient's entire body. The size of the puncture varies depending on the procedure and the system being inserted. Depending on the procedure, the femoral artery or femoral vein is generally utilized as an entry point into the patient's body. A typical puncture can range from 2 mm to over 10 mm in diameter, or from 6 French (Fr) to over 30 French (Fr) for interventional procedures.

[0004] Other procedures, such as those that may encounter the use of endoscopes or other instruments, may utilize trocars for insertion. Typical trocar punctures may range in diameter from 2 mm to over 15 mm, or from 6 French (Fr) to over 45 French (Fr). Closure of such openings is typically accomplished using multiple levels of surgical sutures.

[0005] Upon completion of an interventional diagnostic or therapeutic procedure utilizing a vascular puncture as an entry site, whether in the peripheral circulation, coronary circulatory system or heart, the device and introducer casing can be removed, leaving the puncture site within the vessel wall or body organ.

[0006] Such perforations may be closed using common open surgical techniques utilizing a single knot or a running surgical suture and sutured tightly.

[0007] Another open procedure for stopping bleeding is the use of clips or staples. One form of hemostatic clip is shown in U.S. Patent No. 4,217,902 to March et al., which requires open surgical entry of a perforation to allow operation of the clamping mechanism. More sophisticated surgical staplers have also been described, such as those shown in U.S. Patent Application Publication No. 2008 / 272173 to Coleman James et al., which require open entry.

[0008] A variety of procedures and devices have been developed to address hemostasis following puncture of a blood vessel for a diagnostic or therapeutic procedure in a closed, non-surgical manner.

[0009] A common method for stopping bleeding is to apply pressure to the site of the puncture and wait for the patient's natural blood clotting and self-healing properties to seal the vascular opening. Such pressure is required for a relatively long period of time, such as 30 minutes up to an hour, after which the patient is essentially immobilized and bedridden during this time with heavy sandbags placed over the puncture site to apply pressure for several hours until the bleeding stops. There is an additional risk of hematoma from bleeding before complete hemostasis and sealing occurs. This procedure can be time consuming and has associated disadvantages.

[0010] When the size of the vascular perforation increases, such as in a prosthetic heart valve implant or heart valve repair system, compressing the perforation and waiting for the opening to close naturally becomes less effective or may even be ineffective.

[0011] Although excessive bleeding can already occur in individuals with normal blood clotting responses, some patients are taking anticoagulants that inhibit clotting, suffer from bleeding disorders, hypertension or obesity, which increases the risk of excessive bleeding after removal of the penetrating casing or procedure system.

[0012] An improved method for stopping bleeding is by applying collagen or polymer plugs as shown in U.S. Patent No. 5,275,616. Such procedures are particularly effective in smaller perforations. However, placement of such plug materials increases the risk of intravascular thrombus formation and the development of inflammatory responses.

[0013] To avoid open entry closure, various percutaneous clips or staplers have been developed: the system is inserted over an already utilized guidewire and the clip is operated percutaneously.

[0014] Various percutaneous suturing systems have been developed with closure systems that provide multiple needles joined by sutures. After the needles pass through the vessel wall surrounding the opening, they are captured, pulled outward, tied, and the knot is pushed back through the vessel to complete the closure. Placement of the suture needles requires proper engagement of the tissue so that the placed sutures can hold and close the hole, which limits the system to closure of fairly small vessel perforations.

[0015] In procedures involving perforation of body cavities and organs, such as thoracoscopic, laparoscopic or endoscopic surgery, it is common to enter the patient's body with a suitably sized trocar large enough to insert the applicable system. Closure of such large perforations is generally performed by open surgical suturing. [Prior art documents] [Patent documents]

[0016] [Patent Document 1] U.S. Pat. No. 4,217,902 [Patent Document 2] US Patent Application Publication No. 2008 / 272173 [Patent Document 3] U.S. Pat. No. 5,275,616 Summary of the Invention [Problem to be solved by the invention]

[0017] An object of the present invention may be to propose a further medical apparatus for closing holes and a method therefor. A closure device is also proposed. [Means for solving the problem]

[0018] The above mentioned object is achieved, for example, by a medical device for closing a hole, having the features of claim 1. It is further achieved by a method for closing a hole, having the features of claim 25, and by a closure device, having the features of claim 26.

[0019] In all of the above and following descriptions, the use of expressions such as "may be" or "may have" should be understood as being synonymous with "preferably is" or "preferably has", respectively, and are intended to exemplify embodiments according to the present invention.

[0020] Whenever numerical words are mentioned herein, those skilled in the art shall recognize or understand them as an indication of a lower limit of numerical value. Thus, unless this results in a clear contradiction to those skilled in the art, those skilled in the art shall understand, for example, "one" as including "at least one". This understanding is also equally encompassed by the present invention as an interpretation that a numerical word, for example "one", may alternatively mean "exactly one", whenever this is clearly technically possible from the viewpoint of the skilled artisan. Both of these understandings are encompassed by the present invention and apply to all numerical words used herein.

[0021] If the subject matter of the invention is disclosed herein as comprising one or several features in certain embodiments, it is also disclosed herein respectively that the subject matter according to the invention does not explicitly comprise this or these features in other embodiments which are also according to the invention, e.g. within the meaning of the claims. For each embodiment mentioned herein, the opposite embodiment, for example formulated as a negation, is also disclosed.

[0022] The present invention therefore proposes a medical device for closing holes, incisions, punctures, passages through tissue and / or communication with blood vessels or other body cavities (holes for short) in the tissue of a patient. Herein, the medical device comprises a closure device holder for releasably receiving and / or holding one or more closure devices. The medical device further comprises a retraction unit. The retraction unit may be designed or arranged to preferably contact the opposing side of the tissue of the hole during use of the medical device in order to retract the tissue or tissue and / or to widen the hole, optionally resulting in a slit or a slit-like or more slit-like change in the shape of the hole. For this purpose or to achieve this, the retraction unit may be suitably configured. For example, this retraction action or this change may be achieved by widening the gap or distance between the parts of the retraction unit (for example between the retraction devices or between their arms or between the tips of said arms (if provided)), which may result in an enlargement or increase in the size or diameter of the hole in at least one or exactly one dimension of the hole.

[0023] Further, a method of closing a hole in tissue is proposed, comprising the steps of first providing a medical device according to the present invention and second closing the hole using the medical device.

[0024] Advantageous developments of the invention are the subject matter of the dependent claims and embodiments respectively.

[0025] Whenever an embodiment is mentioned herein, it represents an exemplary embodiment according to the present invention. Whenever the invention is mentioned herein, the present invention is meant.

[0026] Embodiments according to the invention may include one or several of the features mentioned above and / or below in any combination which is technically possible.

[0027] In some embodiments, the retraction unit of the medical device according to the invention comprises at least one retraction device holder and at least one retraction device. The retraction device may be at least partially accommodated in the retraction device holder. The retraction device may optionally be at least partially accommodated in the retraction device holder, preferably in a releasable manner, and is preferably arranged in the retraction device holder in a movable or slidable manner relative to the retraction device holder.

[0028] The retraction device holder may have both a distal end, which is preferably configured to be advanced or extended through or into the hole to be closed, and a proximal end.

[0029] In some embodiments, the retraction unit of the medical apparatus according to the present invention comprises at least one engagement device connected to said retraction device for releasably engaging tissue.

[0030] In some embodiments, the engagement device may have a closed cross-section with an opening therethrough. The closed cross-section may have the shape of a rectangle, a square, a circle, an oval, or a combination thereof.

[0031] In some embodiments, the engagement device may comprise or consist of a wire.

[0032] In some embodiments, the engagement device may be formed from a single wire.

[0033] In some embodiments, the engagement device may have or cover a convex or concave shape, while in other embodiments it is a flat, planar or substantially planar surface.

[0034] In some embodiments, the engagement device of a medical apparatus according to the present invention is foldable and / or configured to be at least partially contained or captured within a retraction device holder.

[0035] A mechanism may be provided for moving the engagement device and / or the retraction device into and out of the retraction device holder.

[0036] In some embodiments, the engagement device may be connected to the retraction device described above such that the engagement device is configured to engage tissue surrounding the hole from within or below the opening of the hole.

[0037] In some embodiments, the at least two retraction devices and / or the at least two engagement devices of the medical apparatus according to the invention are releasably captured in a retraction device holder, in particular such that they are configured to be at least partially released from the retraction device holder by manipulating the retraction device holder or the engagement devices or a mechanism configured to do so as required, in particular to be positioned below the opening level of the hole to be closed.

[0038] In some embodiments, the retraction device holder and / or the retraction device and / or said engagement device of the medical apparatus according to the invention are configured to retract opposing sides of the hole, in particular so that the hole changes its shape. For example, the hole may change from a somewhat rounded shape to a slit hole. Preferably, this results in a stretched transverse diameter that is at least twice the length of the retracted longitudinal diameter of the hole. "Transverse" may refer to a direction perpendicular to the longitudinal direction of the blood vessel. The longitudinal diameter may extend in the direction of the longitudinal axis of the blood vessel.

[0039] In some embodiments, the retraction unit of the medical device of the present invention comprises: a first side and an opposite second side; A first arm and a second arm, A first retraction device and a second retraction device, a first retraction device holder and a second retraction device holder, and / or A first engagement device and a second engagement device; The at least one retraction device has at least one of:

[0040] Further, the retraction unit or any other component may have a mechanism for moving the first side away from or away from the second side, moving the first arm away from or away from the second arm, moving the first retraction device away from or away from the second retraction device, moving the first retraction device holder away from or away from the second retraction device holder, and / or moving the first engagement device away from or away from the second engagement device.

[0041] In some embodiments, the features described above include or consist of shape memory properties.

[0042] In some embodiments, the mechanism may include or consist of mechanical means including, for example, gears, rods, actuation means, control means such as knobs or handles, etc.

[0043] In certain embodiments, the optional knob and / or handle member or handle member casing (or at least a portion of each) of the medical device is made from resin, plastic, fiberglass, wood, metal, or a composite material, or a combination of materials mentioned herein. In other embodiments, the optional knob and / or handle member or handle member casing (or at least a portion of each) of the medical device is not made from resin, or from plastic, or from fiberglass, or from wood, or from metal, or from a composite material, or from a combination of materials mentioned herein.

[0044] In some embodiments, the handle member or its casing comprises at least one slider, for example for a user, hi other embodiments, the handle member or its casing does not include a slider.

[0045] In some embodiments, the handle member or its casing comprises at least one rotational element to convert rotation to translation, for example for a user, while in other embodiments the handle member or its casing does not include such a rotational element.

[0046] In some embodiments, the mechanism may comprise or consist of a vacuum device configured to modify the shape of the retraction device, retraction unit or any other component, etc., such that a first side or first arm, etc., is isolated or moved away from a second side or second arm, etc.

[0047] The vacuum device may be configured to suck fluid (e.g. air) from an internal, preferably closed, lumen of, e.g., the retraction unit such that the cross-section of the component, e.g., the retraction unit, changes by increasing in a first dimension but decreasing in a second dimension perpendicular to the first dimension, by attempting to achieve a vacuum inside the lumen. In this way, e.g., opposing first and second sides of the retraction unit move away from each other while the circumference of the retraction unit remains constant.

[0048] The preferably closed lumen in fluid communication with the vacuum device can have a longer cross-section in a first direction in at least one state (whether or not vacuum is applied) than in a second direction perpendicular to the first direction.

[0049] In some embodiments, the retraction unit or retraction device has a bend or step or bends in front or behind it that can be used as a stop or provide tactile feedback to the surgeon during partial withdrawal of the medical device from the vessel lumen. The bend, step, etc. can indicate that the tip of the medical device, or its retraction unit, retraction device, etc., has come to rest at the edge of the vessel or hole. This indicates that the medical device is in a suitable position to deploy the closure device. To achieve this, the bend, step, etc. is located, for example, less than a predetermined distance from the free end of the medical device or retraction device. The bend, step, or the location where it bends can also act as a protection against withdrawing the medical device too far from the vessel lumen before releasing the closure device.

[0050] In some embodiments, the medical device does not include and / or is not connected to a vacuum device or source.

[0051] In some embodiments, the medical device is not a pressure stabilizer.

[0052] In some embodiments, parts of the retraction device (e.g., the tips of their arms, if provided) deflect or move away from each other when released or in an unstressed state and / or when used to retract tissue.

[0053] In some embodiments, parts of the retraction device (e.g., the two arms or the tips of those arms, if provided) deflect or move away from each other when released or in an unstressed state and / or when used to retract tissue in a common plane, and the longitudinal axes of the handle members may be part of this plane or may have an angle of less than 10°, 15° or 20° relative to this plane.

[0054] In some embodiments, the retraction device and the closure member or parts thereof may each at least partially exit from the same handle member.

[0055] In some embodiments the retraction unit is designed to enlarge or increase the size or diameter of the hole in at least one or exactly one dimension of the hole, for example by contacting and retracting opposing sides of the hole or tissue surrounding the hole, and / or widening the hole, causing the shape of the hole to become a slit or a slit-like or more slit-like hole, or by widening the space or gap between parts of the retraction device, for example by moving the arms of the retraction device or the tips of these arms away from each other, if provided.

[0056] In some embodiments, a medical apparatus according to the present invention comprises at least one closure device contained within a closure device holder.

[0057] In some embodiments, the closure device of the medical device of the present invention is at least partially contained within the closure device holder in a stressed state of the closure device, particularly within the distal end of the closure device holder, especially when the closure device is in an undeployed state, where the closure device preferably has two or more ends and a joint connecting the two or more ends, e.g., via two or more arms.

[0058] In some embodiments, the closure device of the medical device of the present invention is contained within the closure device holder such that when the closure device is manipulated out of the distal end of the closure device holder during use of the medical device, the closure device relieves its stress or a portion thereof, for example, by bending two or more arms out of the closure device holder, such that the two or more ends are positioned to pierce the inner wall of the tissue surrounding the hole.

[0059] In some embodiments, at least a portion of the closure device, retraction device, retraction device holder, and / or engagement device of the medical apparatus of the present invention is made of a deformable shape memory alloy and / or has a self-expanding shape memory portion or wire body.

[0060] In some embodiments, at least a portion of the closure device, retraction device, retraction device holder and / or engagement device of the medical apparatus of the present invention are made of Nitinol.

[0061] In some embodiments, at least a portion of the closure device, retraction device, retraction device holder and / or engagement device of the medical apparatus of the present invention are made from a biocompatible and / or bioabsorbable material.

[0062] In some embodiments, the biocompatible and / or bioabsorbable material is at least one material selected from the group consisting of Ti, Ti alloys, Nitinol, stainless steel, polymeric materials, and ceramics.

[0063] In some embodiments of the medical devices of the present invention, the closure device, or a portion thereof, curls into a closed configuration (e.g., having a through opening surrounded by arms, struts, etc. of the closure device) when in an unstressed state.

[0064] In some embodiments of the medical apparatus of the present invention, the closure device, or a portion thereof, curls into a loop or ring or circle-like shape when in an unstressed state.

[0065] In some embodiments of the medical apparatus of the present invention, the closure device after deployment has a cross-sectional dimension in the range of 10 micrometers to 1 centimeter, preferably 40 micrometers to 200 micrometers, and more preferably 50 micrometers to 100 micrometers.

[0066] In some embodiments, the closure device has two arms.

[0067] In some embodiments, at least one of the arms has at least one or a first bending direction and at least one or a second bending direction, such that at least one or a first portion of the arm is bent in a first bending direction while at least one or a second portion of the arm is bent in a second bending direction, and the first and second bending directions are at least one of: not identical to one another, point opposite one another, point away from one another, etc.

[0068] In some embodiments, in a closed state of the closure device or vascular hole, an end or tip of a first one of the arms points away from a second one of the arms, while an end or tip of the second arm points away from the first arm.

[0069] In some embodiments, the medical device comprises or consists of a handle member (or handle or handle device).

[0070] In some embodiments, to actuate or advance the retraction device, the handle member can have a first slider and, optionally, a second slider arranged to be moved by a user, preferably in the longitudinal direction of the handle member.

[0071] Optionally, at its end position, or at another position, the first slider may be locked in place.A suitable mechanism may be provided, for example on the handle member.

[0072] In some embodiments, all or a portion of the closure device holders are completely or only partially parallel to one another.

[0073] In some embodiments, the casing of the handle member includes an opening through which a switch can be moved by a user to advance the closure device holder relative to the casing of the handle member.

[0074] In certain embodiments, the closure device holders are positioned to remain parallel to one another throughout the closure of the vascular opening, while in other embodiments, they are positioned to move away from one another or diverge from one another as they are advanced toward the vascular opening.

[0075] In some embodiments, the closure device holders are not parallel to each other, or only parts of them (e.g., their proximal portions) are parallel, but not, for example, their distal portions (e.g., their tips). In certain embodiments, the proximal portions are parallel to each other. In some embodiments, the distal portions are optionally under an angle with respect to each other.

[0076] In some embodiments, the distance between the tips or distal ends of portions of the closure device holder is greater than the diameter of the opening in the medical device or handle member through which the closure device holder exits to close the vascular opening, for example, when advanced toward the vascular opening for closure.

[0077] In certain embodiments, the distance between the tips or distal ends or any other corresponding portions of the closure device holders is equidistant between adjacent closure device holders in their unstressed or fully deployed state and / or when advanced to close a vascular hole.

[0078] In certain embodiments, for example, the distance between the tips or distal ends of the portions of the retraction device or their arms when advanced toward a vascular hole for closure or in its unstressed or fully deployed state is greater than the distance between the tips or distal ends of the portions of the closure device holder described above.

[0079] In some embodiments, a delivery support is provided to ensure that the closure device holders deflect or move away from one another as they are advanced towards the vascular opening.

[0080] In some embodiments, the delivery support comprises or consists of a wire, a wire net or a structure.

[0081] In some embodiments, the delivery support is a collapsible and / or non-collapsible element.

[0082] In some embodiments, a closure device holder or delivery support bumper is located on the exterior or side of the closure member.

[0083] In some embodiments, the handle member comprises a sleeve or another preferably rotatable or cylindrical element, optionally having a U-shaped or V-shaped guide slot, which may be part of the outer surface of the sleeve or may be added to the outer surface of the sleeve.

[0084] In some embodiments, the guide slot includes a first slot portion and a second slot portion, each connected to each other by another slot portion, called a turn point.

[0085] In some embodiments, the handle member, knob, or sleeve itself comprises a resilient element, spring, or the like arranged to similarly guide the pin through the pivot point of the guide slot.

[0086] In some embodiments, the retraction device comprises multiple (here two) arms.

[0087] In some embodiments, the arm of the retraction device comprises two legs, referred to as the outer leg and the inner leg.

[0088] In some embodiments, the outer leg and the inner leg may be welded together at or by a welded portion.

[0089] In some embodiments, the outer leg and the inner leg surround or circumscribe one or two intermediate openings that may be or form a trough opening between them.

[0090] In some embodiments, the inner leg is straight or substantially straight.

[0091] In some embodiments, the outer leg is bent to have or form a depression, bulge or indentation.

[0092] In some embodiments, the arms of the retraction device each exit through a separate opening in the retraction unit, while in other embodiments some or all of the arms exit through a common opening in the retraction unit.

[0093] In some embodiments, at least one of the openings in the retraction unit through which the arms exit in use has a width that is less than its length.

[0094] In some embodiments, at least one of the openings in the retraction unit through which the at least one arm exits has an elliptical opening area.

[0095] In some embodiments, the medical device according to the invention further comprises a pressing device, preferably extending through the proximal end of the closure device holder, for manipulating the closure device, which may be configured not to deform the closure device by acting on it, e.g. by pressing it.

[0096] In some embodiments of the medical apparatus according to the present invention, the pushing device is or comprises a rod or piston.

[0097] In some embodiments, the medical apparatus according to the present invention further comprises a holding or extraction device extending through the proximal end of the closure device holder for manipulating the closure device, wherein said holding device is particularly releasably attached to or connected to the closure device.

[0098] In some embodiments, the retention device of the medical device of the present invention is a string or suture.

[0099] In some embodiments, the closure device holder of the medical device of the present invention has one or more grooves on the inner wall of the closure device holder and / or one or more grooves on the pressing device for guiding a holding device along the longitudinal direction of the closure device holder, preferably through or along the grooves.

[0100] In some embodiments of the medical device according to the invention, the distal end of the closure device holder has two or more channels on the wall of the closure device holder. These channels allow one or more ends of the closure device to exit the closure device holder when the medical device is operated or when needed by the user. The ends may exit from one side or both sides of the closure device holder. The channels may be slit-like. The channels or their proximal ends may be surpassed in the distal direction of the closure device holder by the distal end.

[0101] In some embodiments of the medical device of the present invention, the distal end of the closure device holder has at least one channel or two channels arranged on opposite sides of each other on the wall of the closure device holder, particularly within the circumference of the closure device holder.

[0102] In some embodiments of the medical apparatus according to the invention, the retraction device holder is or comprises an elongated tube, for example including or made of metal or plastic, preferably configured to capture the retraction device.

[0103] The closure device holder can have a distal end for being advanced or extended through or into a hole in tissue, and a proximal end that is particularly suited for providing access for manipulating the closure device when and if contained within the closure device holder.

[0104] In some embodiments, at least one of the closure device holder and the retraction unit are slidably and / or movable relative to each other within the medical device, relative to other elements of the medical device, and / or relative to a casing or outer sheath of the medical device.

[0105] In some embodiments, the medical device comprises some or all of the elements of the medical device (obviously excluding the housing or casing and the like), in particular the outer housing, sheath or casing with the closure device holder and / or retraction unit.

[0106] In some embodiments, the medical device comprises a lumen for guiding and / or surrounding a guidewire. The lumen may be open to both the distal and proximal ends of the medical device, or only to one of them.

[0107] In some embodiments, the medical device includes several lumens or openings, for example, one of which can accommodate a first closure device holder and another of which can accommodate a second closure device holder, a retraction device holder, and / or any other element of the medical device.

[0108] Any lumen of the medical device may be a through opening in the medical device, preferably extending longitudinally through the medical device.

[0109] In some embodiments, the medical device has an outer housing or unit that is inflexible and / or flexible along its entire length or only a portion of it.

[0110] In some embodiments of the method of the present invention, the method further comprises: Introducing a portion of the retraction unit into the hole; - contacting opposite sides of the hole with a retraction unit or an element contained therein; - retracting opposite sides of the hole and / or widening the hole by means of a retraction unit or an element contained therein; Releasing at least one closure device from the closure device holder and connecting opposing sides of the hole to each other with the closure device.

[0111] In some embodiments of the method according to the invention, the step of retracting the opposing sides of the hole and / or the step of widening the hole results in a hole whose shape changes, for example to a slit or slit-like or more slit-like, which may result in an enlargement or increase in the size or diameter of the hole in at least one or exactly one dimension of the hole.

[0112] In some embodiments, at least one of the closure device holder and the retraction device holder is a partially hollow tube.

[0113] In some embodiments, at least one of the closure device holder and the retraction device holder is disposed within a common casing or housing and is preferably slidable or movable relative to the casing.

[0114] In some embodiments, the closure member is the same as the closure device holder.

[0115] In some embodiments, the retraction unit is identical to the retraction device holder.

[0116] In some embodiments the retraction unit and the closure member are embodied by only one device.

[0117] In some embodiments, the device does not have a guidewire, however, the device may have a lumen for passing a guidewire through and / or along the length of the device.

[0118] In some embodiments, the closure device is a staple or clip, a wire structure, etc. It may have any of the features disclosed herein in any arbitrary combination.

[0119] In some embodiments, the closure device holder is not configured to eject or release a closure device, particularly a staple or clip, in a first direction, in which case a component of the device or closure device holder configured to eject or assist in ejecting the closure device is configured to be at best (or at least ideally) movable in the first direction or at best substantially in the first direction, but in those embodiments, the component is not configured or positioned to be movable in a second direction substantially perpendicular to the first direction.

[0120] In some embodiments, at least one of the closure device holder and the device does not have a device configured to plastically deform the closure device, in particular does not have a device configured to plastically deform the closure device during ejection or release, and preferably no device is provided for closing the closure device.

[0121] In some embodiments, the closure device holder is configured to eject or release two or more closure devices simultaneously. For example, the closure devices may be ejected from one common opening of the holder and they move away in parallel through this opening. Alternatively, the configuration may be such that two or more closure devices leave the closure device holder or device through separate openings but at the same time.

[0122] In some embodiments, the closure device holder is configured such that the closure device can only be ejected or released in the longitudinal direction of the closure device holder.

[0123] In some embodiments, the closure device holder is configured such that the closure device can only be ejected or released at the same position relative to the length or longitudinal direction of the closure device holder.

[0124] In some embodiments, the retraction unit comprises at least two elements, such as two sides, two arms, two retraction devices, or two retraction device holders, that move away from each other while reaming the hole.

[0125] In some embodiments, the retraction unit and the closure device holder are separate from each other, in particular they can be moved separately from each other, in other embodiments they are interconnected with respect to each other or embodied by the same unit, such that they cannot be moved independently of each other.

[0126] In some embodiments, the retraction unit and the closure device holder are positioned spaced apart from each other such that the closure device holder is configured to eject or release one or more closure devices into tissue to close the long edge or seam of the hole in the retracted state of the hole, i.e., while the hole is being retracted or enlarged by the retraction unit.

[0127] In some embodiments, at least one of the components of the retraction unit configured to retract the opposing sides of the holes by directly contacting them is an elongated or rectangular section, at least one of which may have a shape such as a pole or tube, which is preferably straight.

[0128] In some embodiments, at least one of the components of the retraction unit (e.g., the first and second arms or portions, the first and second retraction devices, the first and second retraction device holders, and / or the first and second engagement devices) configured to retract by directly contacting opposing sides of a hole does not include one or more hinges, articulations, joints or portions where it bends, particularly in its central portion, and more particularly, portions that do not face in opposite directions to each other.

[0129] In some embodiments, a component of the retraction unit configured to retract opposing sides of the hole by directly contacting those sides has a free distal end.

[0130] In some embodiments, some or all of the components of the retraction unit configured to retract opposing sides of the hole by directly contacting them are configured to move relative to each other in a first common plane while retracting the hole. Optionally, in these or different embodiments, at least one closure device extends completely or substantially in a second plane (e.g., in the deployed state of the closure device, e.g., when released or ejected). The closure device may also optionally close in the second plane. For example, the closure device may comprise arms or tines that move towards each other when closed or deployed. The movement may also be substantially in one plane, i.e., in the second plane. The first plane and the second plane may intersect each other. They may be substantially perpendicular to each other.

[0131] In some embodiments, some or all of the components of the retraction unit configured to retract opposing sides of the hole by directly contacting them are configured to move relative to each other in a first direction while retracting the hole. Optionally, in these or different embodiments, the device is configured to eject or release at least one closure device in a second direction. The first and second directions may be different from each other. In fact, they may be perpendicular or substantially perpendicular to each other. Thus, the direction of the retraction movement may be perpendicular or substantially perpendicular to the direction in which the closure device is ejected or released and / or the direction in which the closure device closes when the device is used by the surgeon.

[0132] In some embodiments, the first and second retraction devices, or the first and second arms or portions thereof, are connected to each other by only one hinge or joint or hinge portion or joint portion. The hinge or joint or portion may be arranged to move, preferably exclusively, inside the retraction device holder and / or along the longitudinal axis of the medical device or retraction device holder. Additionally or alternatively, the hinge or joint or portion may be arranged to move, preferably exclusively, in a second direction rather than in a first direction. Thus, in these embodiments, the hinge or joint or portion may optionally not move in a direction in which the opposite sides of the hole are retracted or widened.

[0133] There is also proposed a medical device for closing a hole in tissue according to the invention, The medical device comprises: a closure device holder having a distal end for extending through the tissue hole in a deployed state of the medical device and a proximal end for providing access for manipulation of the closure device; a closure device that is at least partially captured in a stressed state within a distal end of the closure device holder when the medical device or closure device is in an undeployed state, the closure device having two or more ends and a joint connecting the two or more ends via two or more arms; Equipped with When the closure device is manipulated to exit the distal end of the closure device holder during deployment of the medical device or closure device, the closure device is configured relative to the closure device holder such that it relieves its stress by bending two or more arms out of the closure device holder, thereby causing the two or more ends to pierce the inner wall of the tissue surrounding the hole.

[0134] A method for closing a hole in tissue according to the present invention is also proposed, This method is Providing a medical device according to the present invention; and closing the hole with a medical device.

[0135] In some embodiments of the present invention, at least a portion of the closure device is made from a deformable shape memory alloy.

[0136] In some embodiments of the present invention, at least a portion of the closure device is made from Nitinol.

[0137] In some embodiments of the present invention, at least a portion of the closure device is made from a biocompatible and / or bioabsorbable material.

[0138] In some embodiments according to the present invention, the biocompatible and / or bioabsorbable material is at least one material selected from the group consisting of Ti, Ti alloys, Nitinol, stainless steel, polymeric materials, and ceramics.

[0139] In some embodiments of the present invention, the closure device curls into a closed configuration when in an unstressed state.

[0140] In some embodiments of the present invention, the closure device curls into a loop, ring or circle when in an unstressed state.

[0141] In some embodiments of the present invention, the closure device after deployment of the medical apparatus has a cross-sectional dimension in the range of 10 micrometers to 1 centimeter, preferably 40 micrometers to 200 micrometers, and more preferably 50 micrometers to 100 micrometers.

[0142] In some embodiments according to the invention, the medical apparatus includes a pushing device extending through a proximal end of the closure device holder for manipulating the closure device.

[0143] In some embodiments according to the invention, the pushing device is a rod or a piston.

[0144] In some embodiments according to the invention, the medical apparatus includes a holding device extending through a proximal end of the closure device holder for manipulating the closure device, said holding device being mounted with the closure device.

[0145] In some embodiments of the present invention, the retention device is a string or suture.

[0146] In some embodiments of the present invention, the closure device holder has one or more grooves on the inner wall of the closure device holder and / or one or more grooves on the pressing device for guiding the holding device along the longitudinal direction of the closure device holder.

[0147] In some embodiments of the present invention, the distal end of the closure device holder has two or more channels on the wall of the closure device holder to allow one or more ends of the closure device to exit the closure device holder when the closure device is deployed.

[0148] In some embodiments according to the invention, the distal end of the closure device holder has two channels located on opposite sides of the wall of the closure device holder.

[0149] Most of the state-of-the-art systems, such as those utilizing plugs, clips, or sutures, are only capable of closing fairly small sized arterial punctures, up to 10 French (Fr), and are approved only for arterial entry sites. Some of the systems are used off-label to close larger arterial or venous punctures.

[0150] The present invention can advantageously provide a more effective method and medical device for sealing large foramen punctures, up to 30 French (Fr) or larger, of veins and other passageways through tissue.

[0151] The present invention allows for the connection of tissue segments to one another or for closing and / or sealing openings through tissue, such as very large holes, vascular perforations, etc. in the venous system, particularly the femoral vein.

[0152] Such large vascular access and drilling is required for more complex interventional procedures such as transseptal mitral and tricuspid valve repair and prosthetic implantation.

[0153] The femoral vein has a diameter of about 8 mm or more, or about 24 French (Fr) or more, allowing the introduction of systems with similar diameters. It is very difficult to close such a large perforation in the vein with a percutaneous system utilizing plugs, sutures or clips. There is a high risk of vascular stenosis when closing such a large perforation with a circular or longitudinal technique.

[0154] According to the invention, a specific technique is advantageously used to elongate the perforation in a direction perpendicular to the vessel long axis and to closely suture the perforation along this elongation, thus avoiding narrowing of the vessel lumen.

[0155] The present invention allows for the closure of large caliber vascular punctures, particularly in veins, by elongating the puncture perpendicular to the vessel long axis and placing a single clip along the elongation which closes the puncture along the line of elongation.

[0156] In some embodiments, the medical device can include a handle member, a tubing set coupled to the handle member on one side (not shown) and the other side, and a retraction unit and a closure member that are subsequently or simultaneously deployed into the tissue hole. The handle member can also include any number of mechanisms (not shown) necessary to deploy the retractor and closure member. The retraction unit and closure member are disposed through a casing that allows these units and members to be at least partially disposed into the blood vessel hole or lumen in a controlled manner, particularly along a guide structure such as a guidewire or other rail (not shown) that is typically disposed within the blood vessel to perform an interventional procedure.

[0157] The retraction unit optionally includes two retraction device holders having distal ends configured to extend through the holes and be positioned on opposite insides of the hole to be closed. The retraction devices or their holders can have engagement devices attached, for example, to their distal ends. The engagement devices may be configured to engage opposite ends of the hole and opposite ends of the inner vessel wall, for example by contacting, pressing, and / or leaning. The engagement devices are configured to move apart and retract opposite sides of the hole, approximating opposite sides of the hole between the retraction devices, such that the hole becomes straight with one extended major axis and an orthogonal contracted minor axis.

[0158] The closure member optionally includes one or more closure device holders having a distal end extending through the hole to be closed, the closure device holder having, for example, a closure device attached to the distal end, the closure device configured to engage the tissue wall when the closure device holder is withdrawn.

[0159] The closure device is preferably a sharp needle that penetrates the tissue wall surrounding the hole as the closure device holder is withdrawn. When the closure device engages the tissue wall, it can be detected as a firm resistance to further withdrawal.

[0160] The closure device is then deployed and further bent into a circular configuration, drawing the laterally retracted ends of the hole together in a manner that linearly closes the hole.

[0161] The closure device optionally comprises a plurality of circular needles sized, oriented and configured such that when the closure device is moved from inside to outside the hole, the closure device bends into an anchor shape according to a preset memory shape of the closure device, perforating the tissue wall and grasping tissue adjacent the wall to draw the tissue surrounding the perforation into proximity of the closed hole and close the hole, with the drawn-in surrounding tissue further sealing the tissue closure.

[0162] The closure device or devices can optionally be disengaged from the closure device holder and delivery mechanism and left in place.

[0163] With the tissue hole thus closed, hemostasis can be achieved within the vessel by leaving the closure device attached to the tissue wall. The closure device may be constructed of metal, plastic, or bioabsorbable material, preferably with a material memory effect.

[0164] In some embodiments of the present invention, a medical device is proposed that includes one or more retraction units for use in closing a hole, incision, puncture, or other passageway through tissue, or communication with a blood vessel or other body cavity.

[0165] The retraction unit may, for example, have two retraction device holders having distal ends for extending through the hole to be closed and proximal ends for selectively providing manipulation.

[0166] The engagement device is captured in a retraction device holder and released by manipulation and positioned below the hole to be closed, said manipulation of said retraction device holder causing retraction of opposite sides of the hole, changing the shape of the hole from a somewhat rounded hole to a slit hole whose stretched transverse diameter (which is the long diameter of the hole after retraction) is at least twice the length of the retracted longitudinal diameter of the hole (which is the short diameter).

[0167] In some embodiments of the present invention, a medical device is proposed for use in closing a hole in tissue, the medical device comprising a closure member having a distal end for extending through the hole to be closed, a closure device holder having a proximal end for selectively providing manipulation, and a closure device captured at the distal end of the closure device holder to be deployed, whereby the manipulation of the closure device holder and deployment of the closure device closes the hole.

[0168] In some embodiments according to the invention, the medical device comprises a set of retraction units.

[0169] In some embodiments according to the invention, the medical device includes instructions to the user, embodied for example as signs, arrows or the like, indicating the orientation or direction of the retraction unit of the medical device.

[0170] In some embodiments of the present invention, the medical device further includes a delivery device for delivering the closure device holder, engagement device and closure device into operative proximity with the hole, the delivery device being, for example, slidably connected to the closure device holder.

[0171] In some embodiments according to the invention, the retraction device holder comprises an elongated tube made of metal or plastic into which the retraction device can be captured.

[0172] In some embodiments of the present invention, the retraction unit can be moved apart to retract the hole.

[0173] In some embodiments according to the invention, the retraction device holder comprises an elongated tube made of metal, plastic or other material capable of capturing the retraction device.

[0174] In some embodiments of the present invention, the closure device holder has a lateral channel at the end of the elongated tube through which the closure device passes as it leaves the closure device holder, preventing the closure device from contacting structures on the opposite side of the end of the elongated tube.

[0175] In some embodiments according to the present invention, the closure member can be manipulated to evenly distribute the closure devices along the line to be occluded.

[0176] In some embodiments of the present invention, the closure device is made of a perforated material, preferably a needle, selected from a class of materials including metals, metal alloys, nitinol, plastics, and preferably has memory effect properties, a permanent protective coating or a bioabsorbable protective coating, and is bioabsorbable.

[0177] In some embodiments, the present invention provides a closure device having a cross-section, a proximal end, and two arms each having a pointed end, which are bending portions of the closure device to expand between a first position when compressed and captured in a second position within said closure device holder. The closure device is substantially straight and can be moved along an axis inside the closure device holder in both directions in a compressed or strained state and released at the end of the closure device holder, causing the arms to return to the expanded second position with the arms having a bent shape and forming a ring having two half circles or semicircles.

[0178] In some embodiments of the present invention, the closure device has a pre-set configuration that allows for connection of the closure device with the closure device holder.

[0179] In some embodiments of the present invention, the present invention relates to a method of closing a hole, incision, puncture, or other passageway through tissue, communication with the wall of a blood vessel or other body lumen, particularly but not limited to a blood vessel having a lumen that carries blood.

[0180] The method comprises: a. retracting the opposing sides of the hole to be closed, specifically changing the hole's shape from a somewhat rounded hole to a more slit-like hole with an axially reduced diameter relative to the vessel long axis and an expanded orthogonal diameter relative to the vessel long axis diameter, in order to connect the enlarged orthogonal sides of the hole; b. inserting and uniformly deploying one or more closure devices into the vessel lumen through the hole, the closure devices being manipulated to engage the vessel wall surrounding the hole with an extended long side of the hole between the shoulders, connecting two extended orthogonal sides of the retracted hole side, and closing the hole; Includes:

[0181] In some embodiments according to the invention, the closing step comprises suturing, clamping, or similar mechanical approximation of the walls of the engaged holes.

[0182] In some embodiments, the retraction unit comprises an engagement device connected to said retraction device for releasably engaging tissue.

[0183] In some embodiments, the engagement device is foldable and / or configured to be at least partially contained or captured within the retraction device holder.

[0184] In some embodiments, the at least two retraction devices and / or the at least two engagement devices are captured in the retraction device holder in a releasable manner, in particular such that they can be at least partially released from the retraction device holder by manipulating the retraction device holder or the engagement devices, in particular such that they are configured to be positioned below the opening level of the hole to be closed.

[0185] In some embodiments the retraction device holder and / or the retraction device and / or said engagement device are specifically configured to retract opposing sides of the hole, e.g. to change the shape of the hole from a somewhat rounded hole to a slit hole, preferably such that the stretched lateral diameter is at least twice the length of the retracted longitudinal diameter of the hole.

[0186] In some embodiments, the feature comprises or consists of a shape memory property.

[0187] In some embodiments, the closure device is at least partially contained within the closure device holder, particularly within the distal end of the closure device holder, in a stressed state, particularly when the medical device is in an undeployed state, and the closure device preferably has two or more ends and a joint connecting the two or more ends, e.g., via two or more arms.

[0188] In some embodiments, the closure device is contained within the closure device holder such that when the closure device is manipulated out of the distal end of the closure device holder during use of the medical apparatus, the closure device relieves its stress or a portion of its stress by bending two or more arms out of the closure device holder, thereby positioning the two or more ends to lead the inner wall of the tissue surrounding the hole.

[0189] In some embodiments, at least a portion of the closure device, retraction device, retraction device holder, and / or engagement device is made of a deformable shape memory alloy and / or has a self-expanding shape memory portion or wire body.

[0190] In some embodiments, at least a portion of the closure device, retraction device, retraction device holder and / or engagement device are made from Nitinol.

[0191] In some embodiments, at least a portion of the closure device, retraction device, retraction device holder and / or engagement device are made from a biocompatible and / or bioabsorbable material.

[0192] In some embodiments, the biocompatible and / or bioabsorbable material is at least one material selected from the group consisting of Ti, Ti alloys, Nitinol, stainless steel, polymeric materials, and ceramics.

[0193] In some embodiments, the closure device, or a portion thereof, curls into a closed configuration when in an unstressed state.

[0194] In some embodiments, the occlusion device, or a portion thereof, curls into a loop, ring, or circle when in an unstressed state.

[0195] In some embodiments, the occlusion device after deployment has a cross-sectional dimension in the range of 10 micrometers to 1 centimeter, preferably 40 micrometers to 200 micrometers, and more preferably 50 micrometers to 100 micrometers.

[0196] In some embodiments, the medical apparatus further comprises a pushing device, preferably extending through the proximal end of the closure device holder, for manipulating the closure device.

[0197] In some embodiments, the pushing device is a rod or a piston.

[0198] In some embodiments, the medical apparatus further comprises a holding device extending through a proximal end of the closure device holder for manipulating the closure device, said holding device being attached to the closure device.

[0199] In some embodiments, the retention device is a string or suture.

[0200] In some embodiments, the closure device holder has one or more grooves on an inner wall of the closure device holder and / or one or more grooves on the pushing device for guiding the holding device along the length of the closure device holder.

[0201] In some embodiments, the distal end of the closure device holder has two or more channels on the wall of the closure device holder, allowing one or more ends of the closure device to exit the closure device holder during operation of the medical device or when required by the user.

[0202] In some embodiments, the distal end of the closure device holder has at least one channel or two channels disposed on opposite sides of a wall of the closure device holder.

[0203] In some embodiments, the retraction device holder comprises, for example, an elongated tube including or made of metal or plastic, preferably configured to capture the retraction device.

[0204] In some embodiments, the method comprises: Introducing a portion of the retraction unit into the hole; - contacting opposite sides of the hole with a retraction unit or an element contained therein; - retracting opposite sides of the hole and / or widening the hole by means of a retraction unit or an element contained therein; Releasing at least one closure device from a closure device holder and connecting opposing sides of the hole to each other with the closure device; Further includes:

[0205] In some embodiments, the step of retracting opposing sides of the hole and / or the step of widening the hole causes the shape of the hole to change, for example to a slit or a slit-like or more slit-like hole, or causes the size or diameter of the hole to be enlarged or increased in at least one or exactly one dimension of the hole.

[0206] In some embodiments, the retraction device is configured to retract the hole in a direction perpendicular to a longitudinal axis of the retraction unit and / or the closure device holder.

[0207] In some embodiments, the retraction device is configured to retract the hole in a direction having an angle of 90 degrees to 45 degrees relative to a longitudinal axis of the retraction unit and / or closure 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 therebetween. Of course, in other embodiments, the angle can be 0 degrees or between 0 and 45 degrees.

[0208] In some embodiments, the retraction device is configured to cause the hole to retract in a direction other than parallel to the longitudinal axis of the retraction unit and / or the closure device holder.

[0209] In some embodiments, the retraction device or retraction unit does not have a motor or mechanism for, for example, rotating or moving an arm or other part to retract opposing sides of the hole around or parallel to an axis that is the longitudinal axis of the retraction unit and / or closure device holder.

[0210] In other embodiments the retraction device or retraction unit comprises a motor and / or a mechanism for acting on the retraction device and / or the retraction device holder.

[0211] In certain embodiments, the retraction device and the retraction device holder are configured such that they cannot move independently of one another.

[0212] In some embodiments, the arms are parts, extensions or protrusions of the retraction device holder. For example, the retraction device holder may have two distal tips, or the ends may be half-moon shaped, C-shaped, and / or any other shape that allows the two parts separated by a gap to diverge from each other and increase the gap or distance between them, for example, when the shape of the retraction device holder changes. Thus, the two tips referred to herein may be understood as arms as referred to herein. Also, what has been said herein with respect to "arms" may also apply unchanged to the tips that are the two free ends of the C-shape or half-moon shape described above.

[0213] The term mechanism as used herein refers to mechanisms that include movably arranged parts, such as plungers, gears, motors, among others.

[0214] In some embodiments, the medical apparatus comprises a deployment device configured to be at least partially releasably received within a lumen of a retraction device holder. The deployment device can comprise a cylindrically shaped body. The cylindrically shaped body can be hollow, partially hollow, or solid. A distal end portion of the deployment device can comprise a cone shaped end. A very distal end, end, or end portion of its tip can comprise a spherically shaped tip.

[0215] In some embodiments, the retraction device is disposed at a distal tip, end or end portion of the retraction device holder. The retraction device and the retraction device holder are preferably designed integrally with each other and / or are preferably connected to each other in a manner that does not allow or require release during the implementation of the invention.

[0216] In some embodiments the retraction device comprises (or consists of) a first arm and a second arm. Preferably the first arm and the second arm are arranged or provided parallel to each other, preferably at least during placement of the retraction unit in the hole.

[0217] In some embodiments, the retraction device comprises (or consists of) a first arm and a second arm that are disposed on or contact a surface of the deployment device during placement of the retraction device in (with respect to) the hole and that extend to a retracted state in the hole after the deployment device is withdrawn from the retraction device holder.

[0218] In some embodiments, the retraction device comprises (or consists of) a first arm and a second arm, the first arm and the second arm releasably attached to or in contact with a surface of the deployment device while advancing the retraction device up to or into the hole, and the first arm and the second arm are extended to assume a retracted state of the hole after the deployment device is withdrawn from the retraction device holder.

[0219] In some embodiments, the retraction device comprises (or consists of) a first arm and a second arm, which are placed on the surface of the deployment device while placing the retraction device in the hole, and which passively expand to the retracted state of the hole without a specific mechanism after pulling the deployment device from the retraction device holder.

[0220] In some embodiments, the retraction device holder or its lumen exhibits, takes on, or exhibits a first shape or first cross-section, preferably a circular cross-section having a cross-sectional diameter, while the retraction unit is positioned within the bore, and a second shape or second cross-section, preferably an elliptical cross-section having a major axis length greater than the cross-sectional diameter, after the deployment device is partially or fully withdrawn from the retraction device holder.

[0221] In some embodiments, the retraction device holder or its lumen exhibits, takes on, or shows a first shape or first cross-section, preferably a circular cross-section having a cross-sectional diameter, during placement of the retraction unit within the bore, and a second shape or second cross-section, preferably an elliptical cross-section having a major axis length greater than the cross-sectional diameter, preferably an oval cross-section having two axes of symmetry, a major axis and a minor axis, after the deployment device is partially or fully pulled from the retraction device holder.

[0222] In some embodiments, the closure device holder or its cross-sectional shape is primarily of or corresponds to the second shape and / or has an elliptical cross-section, preferably with a major axis length slightly less than this length.

[0223] In some embodiments, the retraction device holder or a portion thereof is sufficiently flexible and / or elastic to allow the closure device holder to conform to the shape or cross-section of the retraction device holder while being inserted / introduced into the retraction device holder (preferably without additional assistance (i.e., by being introduced alone)). For example, if the closure device holder or a portion thereof has an oval cross-section, in these embodiments, the retraction device holder or its lumen also assumes an elliptical cross-section. Also, if a deployment device having a circular cross-section is inserted into the lumen of the retraction device holder, the lumen can assume a circular cross-section.

[0224] Thus, in some embodiments, the retraction device holder, or the portion thereof that defines its lumen, may be fabricated from a flexible or resilient material.

[0225] Also, in some embodiments, the retraction device holder or the portion thereof that defines / determines its lumen may be fabricated from a material that does not have a memory effect.

[0226] Thus, in some embodiments, the retraction device holder, or the portion thereof that defines its lumen, may be fabricated from a non-flexible and / or non-resilient material.

[0227] In some embodiments, the medical device comprises one or more bars or other protrusions disposed between or adjacent to the openings of the closure device holder for ejecting the closure device. The bars are disposed to protrude across the open area of ​​at least one opening. They may be integral with the closure device holder and can function to avoid damaging the opposing vessel wall or tissue when releasing the closure device from the closure device holder.

[0228] In some embodiments, the medical device comprises a connector that is connected to or is an integral part of the retraction device holder and provides an opening for advancing the deployment device and / or closure device holder into the lumen of the retraction device holder.

[0229] In some embodiments, the lumen of the connector, or its cross-section, or the open area of ​​the opening, can include both a portion that defines (at least in part) a circular shape and a portion that defines (at least in part) an elliptical shape.

[0230] In some embodiments, the connector can include a seal, membrane, diaphragm, or the like that acts as a seal by conforming or abutting an outer surface of a device inserted through the connector and into the lumen of the retraction device holder.

[0231] In some embodiments, the seal, membrane, diaphragm, etc. may include a slit through the material that accommodates the device and allows the material to deflect or diverge to close the opening again when the device is removed from the retraction device holder.

[0232] Thus, in some embodiments, the shape of the lumen of the connector, or its cross-section, or open area, is not exclusively circular or elliptical.

[0233] In some embodiments, the closure device holder is preferably at least partially releasably housed within the retraction device holder, preferably translationally in the longitudinal direction of the closure device holder.

[0234] In some embodiments, a method for closing a hole in tissue includes: providing a medical apparatus comprising a retraction device holder, a retraction device having a first arm and a second arm, and a deployment device, the retraction device being disposed at a distal end portion of the retraction device holder or attached to the retraction device holder; Inserting a deployment device into a lumen of a retraction device holder; pushing both the deployment device and the retraction device holder including the retraction device forward into the hole until the first arm and the second arm are disposed inside the hole; retracting the deployment device from the lumen of the retraction device holder; inserting a closure device holder having a closure device into a lumen of the retraction device holder, the lumen being optionally generally oval or elliptical in shape, such that upon insertion, one or more distal openings of the closure device holder for ejecting the closure device from the closure device holder are positioned in the hole; pushing, withdrawing or releasing the closure device to close the hole; Optionally, closing the hole utilizing a closure device; Includes:

[0235] In some embodiments, multiple arms are provided that act as or as part of a retraction unit, in some embodiments some or all of the arms are provided in a line or in a common plane, or in contact with or across a common plane.

[0236] In some embodiments, the tips of the retraction units are preferably formed by tips of arms arranged such that they cannot diverge laterally from one another under any circumstances while closing the hole.

[0237] In some particular embodiments, the arms are of different lengths, so that the arms may be provided with two or more different lengths, or some of the arms may be moved a longer length than others from the retraction unit, common sheath, or casing thereof.

[0238] Thus, in some embodiments, the retraction unit 100 may comprise or consist of multiple arms, some of which may differ in length or the extent to which they may be advanced from inside the retraction unit 100 to its outside.

[0239] In certain embodiments, all of the arms of a portion of the retraction unit may be arranged to be advanced to an advanced position and retracted again from the advanced position without bending or deflecting to the side.

[0240] In some embodiments, the arms may be straight or longitudinal components that either cannot be bent during use and / or always run parallel to one another.

[0241] In some embodiments, there is no configuration that the arms can assume (eg, due to a shape memory feature) other than the configuration that the arms have while not advanced.

[0242] The arms may be arranged to be moved from inside to outside the casing or medical device only if they are moved together, and therefore they may be interconnected to each other in such a way that they can only be advanced as a group.

[0243] In some embodiments, a protector is provided. The protector may comprise or consist of a wire.

[0244] The protectors may be connected to the arms and they may be configured to be slid together, or just with the respective arms, out of the casing or relative to other parts of the medical device.

[0245] In some embodiments, one arm is connected to one protector on its upper surface and another protector is connected to its lower surface.

[0246] In some embodiments, the protector is arranged to open in a direction that is preferably perpendicular (or perpendicular) to the longitudinal axis of the retraction unit or each arm.

[0247] The protector may be arranged to open in a direction (or perpendicular) that is preferably perpendicular to the direction of maximum extension of the retraction unit or each arm, in the lateral width of the retraction unit or its casing.

[0248] In some embodiments, the lateral width of the casing or the width or depth of its retraction unit preferably renders the casing or retraction unit non-circular, but rather flat, rectangular, oval, etc. in cross-section.

[0249] In some embodiments, the closure device comprises or consists of two arms, which may be from a common unitary material or may be attached to each other in an attachment area, which may be glued, welded, or otherwise attached to each other.

[0250] In some embodiments, the shape of the occlusion device is not, and preferably is not, symmetrical.

[0251] In some embodiments, the mounting area is angled relative to the centerline of the closure device.

[0252] For example, the mounting area may be inclined at an angle between 20° and 70°, preferably between 30° and 60°, relative to a line perpendicular to the line of maximum width or to a line connecting the tips of the arms.

[0253] In some embodiments, the mounting area includes a through opening 611. The through opening 611 may have a closed circumference or may open towards the circumference with its extension. The extension may be narrower than the radius of the through opening itself. Thus, the extension may change the overall shape of the through opening to a keyhole shape. The extension may be a bottleneck in one plane to the main area of ​​the through opening.

[0254] The wires of the arms of the closure device are preferably made of or comprise flat wires. Flat wires, in contrast to round wires, do not have a circular cross section. Their cross section is oval, rectangular, or otherwise deviates from a circular design. Flat wires allow for higher gripping forces without exceeding the irreversible strain threshold of, for example, Nitinol. It is also believed that the closure device is capable of holding the vessel walls with an associated amount of perivascular tissue, clamping them together to create hemostasis and complete closure.

[0255] In some embodiments according to the present invention, a medical device for closing a hole includes the features disclosed herein in any arbitrary combination, unless considered technically impossible by a person skilled in the art. These and other more detailed and specific objects and understanding of various embodiments of the present invention will become apparent from a consideration of the following detailed description of exemplary embodiments with reference to the drawings. [Brief description of the drawings]

[0256] [Figure 1A] 1 is a schematic side view of one embodiment of a retraction unit of a medical device according to the present invention; [Figure 1B] 1 is a schematic side view of one embodiment of a retraction unit of a medical device according to the present invention; [Figure 1C]1 is a schematic side view of one embodiment of a retraction unit of a medical device according to the present invention; [Figure 1D] 1 is a schematic side view of one embodiment of a retraction unit of a medical device according to the present invention; [Figure 2A] FIG. 13 is a side view of an alternative embodiment of the retraction unit. [Figure 2B] FIG. 13 is a side view of an alternative embodiment of the retraction unit. [Figure 2C] FIG. 13 is a side view of an alternative embodiment of the retraction unit. [Figure 2D] FIG. 13 is a side view of an alternative embodiment of the retraction unit. [Figure 2E] FIG. 13 is a side view of an alternative embodiment of the retraction unit. [Figure 2F] FIG. 13 is a side view of an alternative embodiment of the retraction unit. [Figure 3A] FIG. 13 is a schematic partial cross-sectional view of the retraction unit deployed in the hole. [Figure 3B] FIG. 13 is a schematic partial cross-sectional view of the retraction unit deployed in the hole. [Figure 3C] FIG. 13 is a schematic partial cross-sectional view of the retraction unit deployed in the hole. [Figure 3D] FIG. 13 is a schematic partial cross-sectional view of the retraction unit deployed in the hole. [Figure 4A] FIG. 13 is a side view of an alternative embodiment of the retraction unit. [Figure 4B] FIG. 13 is a side view of an alternative embodiment of the retraction unit. [Figure 4C] FIG. 13 is a side view of an alternative embodiment of the retraction unit. [Figure 4D] FIG. 13 is a side view of an alternative embodiment of the retraction unit. [Figure 5A] FIG. 13 is a schematic partial cross-sectional side view of the retraction unit deployed into the hole. [Figure 5B] FIG. 13 is a schematic partial cross-sectional side view of the retraction unit deployed into the hole. [Figure 5C] FIG. 13 is a schematic partial cross-sectional side view of the retraction unit deployed into the hole. [Figure 5D]FIG. 13 is a schematic partial cross-sectional side view of the retraction unit deployed into the hole. [Figure 6A] 1 is a front view of a closure device of a medical apparatus according to an embodiment of the present invention, with the needle in a preferred expanded circular configuration. [Figure 6B] FIG. 2 is a front view of a closure device of a medical apparatus according to one embodiment of the present invention, with the needle in a preferred compressed straight configuration. [Figure 7A] 7 is a side view of the closure device shown in FIG. 6 positioned in the hole, penetrating the tissue and connecting the free edges of the hole. FIG. [Figure 7B] 7 is a side view of the closure device shown in FIG. 6 positioned in the hole, penetrating the tissue and connecting the free edges of the hole. FIG. [Figure 7C] 7 is a side view of the closure device shown in FIG. 6 positioned in the hole, penetrating the tissue and connecting the free edges of the hole. FIG. [Figure 7D] 7 is a side view of the closure device shown in FIG. 6 positioned in the hole, penetrating the tissue and connecting the free edges of the hole. FIG. [Figure 7E] 7 is a side view of the closure device shown in FIG. 6 positioned in the hole, penetrating the tissue and connecting the free edges of the hole. FIG. [Figure 7F] 7 is a side view of the closure device shown in FIG. 6 positioned in the hole, penetrating the tissue and connecting the free edges of the hole. FIG. [Figure 8] FIG. 2 is a schematic longitudinal side view of a closure member including a linearly folded (understood compressed, i.e., undeployed) closure device captured in a closure device holder. [Figure 9] FIG. 13 is a schematic perspective view of a closure member including a linearly folded closure device captured in a closure device holder. [Figure 10] 2 is a schematic partial cross-sectional longitudinal cross-sectional view of a closure member deployed within a hole in a blood vessel. [Figure 11] 1 is a schematic, partially cutaway, longitudinal cross-sectional view of a closure member advanced into a hole in a blood vessel. [Figure 12A]11 is a schematic partial cross-sectional longitudinal section of the closure member from FIG. 10 and the closure device from FIG. 6 deployed into the hole penetrating the tissue and connecting the free edges of the hole. [Figure 12B] 11 is a schematic partial cross-sectional longitudinal section of the closure member from FIG. 10 and the closure device from FIG. 6 deployed into the hole penetrating the tissue and connecting the free edges of the hole. [Figure 12C] 11 is a schematic partial cross-sectional longitudinal section of the closure member from FIG. 10 and the closure device from FIG. 6 deployed into the hole penetrating the tissue and connecting the free edges of the hole. [Figure 12D] 11 is a schematic partial cross-sectional longitudinal section of the closure member from FIG. 10 and the closure device from FIG. 6 deployed into the hole penetrating the tissue and connecting the free edges of the hole. [Figure 12E] 11 is a schematic partial cross-sectional longitudinal section of the closure member from FIG. 10 and the closure device from FIG. 6 deployed into the hole penetrating the tissue and connecting the free edges of the hole. [Figure 13A] 11 is a schematic partial cross-sectional longitudinal cross-sectional view of the alternative closure member from FIG. 10 and the closure device from FIG. 6 deployed into a hole penetrating tissue and connecting the free edges of the hole. [Figure 13B] 11 is a schematic partial cross-sectional longitudinal cross-sectional view of the alternative closure member from FIG. 10 and the closure device from FIG. 6 deployed into a hole penetrating tissue and connecting the free edges of the hole. [Figure 13C] 11 is a schematic partial cross-sectional longitudinal cross-sectional view of the alternative closure member from FIG. 10 and the closure device from FIG. 6 deployed into a hole penetrating tissue and connecting the free edges of the hole. [Figure 13D] 11 is a schematic partial cross-sectional longitudinal cross-sectional view of the alternative closure member from FIG. 10 and the closure device from FIG. 6 deployed into a hole penetrating tissue and connecting the free edges of the hole. [Figure 13E] 11 is a schematic partial cross-sectional longitudinal cross-sectional view of the alternative closure member from FIG. 10 and the closure device from FIG. 6 deployed into a hole penetrating tissue and connecting the free edges of the hole. [Figure 13F]11 is a schematic partial cross-sectional longitudinal cross-sectional view of the alternative closure member from FIG. 10 and the closure device from FIG. 6 deployed into a hole penetrating tissue and connecting the free edges of the hole. [Figure 13G] 11 is a schematic partial cross-sectional longitudinal cross-sectional view of the alternative closure member from FIG. 10 and the closure device from FIG. 6 deployed into a hole penetrating tissue and connecting the free edges of the hole. [Figure 13H] 11 is a schematic partial cross-sectional longitudinal cross-sectional view of the alternative closure member from FIG. 10 and the closure device from FIG. 6 deployed into a hole penetrating tissue and connecting the free edges of the hole. [Figure 14] FIG. 13 is a schematic partial cross-sectional perspective view of two retraction units advanced into a hole. [Figure 15] FIG. 5 is a schematic partial cross-sectional perspective view of two retraction units deployed in a lumen, the two retraction devices from FIG. 4 being advanced into a blood vessel and deployed within the blood vessel. [Figure 16] FIG. 5 is a schematic partial cross-sectional perspective view of two retraction units deployed in a hole, in which the two retraction devices from FIG. 4 are advanced into a blood vessel and deployed within the vessel, widening the hole. [Figure 17] FIG. 5 is a schematic partial cross-sectional perspective view of two retraction units deployed within a hole, where the two retraction devices from FIG. 4 are advanced into a blood vessel and deployed within the vessel, the two retraction devices are retracted until a stop is felt, and the hole becomes a straight slit and is widened until a stop can be felt. [Figure 18] FIG. 1 is a schematic partial cross-sectional perspective view of two retraction devices and two closure devices deployed simultaneously or sequentially into a hole. [Figure 19] FIG. 7 is a schematic partial cross-sectional perspective view of two retraction devices and two closure devices deployed into a hole, with the hole being retracted and the long edges of the hole being approximated by the partially deployed closure device from FIG. [Figure 20]FIG. 7 is a schematic partial cross-sectional perspective view of two retraction devices and two closure devices from FIG. 6 fully deployed and connecting the long edges of the hole, with the retraction units subsequently being withdrawn. [Figure 21] FIG. 7 is a schematic perspective view of two released closure devices from FIG. 6 closing a hole in a transverse line. [Figure 22] FIG. 1 is a schematic, partially cutaway perspective view of two retraction devices and a closure member advanced simultaneously into a hole in a blood vessel. [Figure 23] FIG. 1 is a schematic partial cross-sectional perspective view of two retraction devices and a closure member deployed into a hole in a blood vessel, the hole being widened in a direction perpendicular to the long axis of the vessel. [Figure 24] FIG. 7 is a schematic partial cross-sectional perspective view of two retraction devices and one closure member advanced further into a hole in a blood vessel, the hole being widened in a direction perpendicular to the long axis of the blood vessel and the long edge of the hole being approximated and penetrated by the partially deployed closure device from FIG. [Diagram 25] FIG. 1 is a schematic partial cross-sectional perspective view of a blood vessel having one closure device closing a hole. [Figure 26A] FIG. 1 is a schematic, partially cut-away perspective view of step (a) of seven steps in an overall procedure for closing a hole in a blood vessel. [Figure 26B] FIG. 13 is a schematic, partially cut-away perspective view of step (b) of seven steps in the overall procedure for closing a hole in a blood vessel. [Figure 26C] FIG. 13 is a schematic, partially cut-away perspective view of step (c) of seven steps in the overall procedure for closing a hole in a blood vessel. [Figure 26D] FIG. 13 is a schematic, partially cut-away perspective view of step (d) of seven steps in the overall procedure for closing a hole in a blood vessel. [Figure 26E] FIG. 13 is a schematic, partially cut-away perspective view of step (e) of seven steps in the overall procedure for closing a hole in a blood vessel. [Figure 26F] FIG. 13 is a schematic, partially cut-away perspective view of step (f) of seven steps in the overall procedure for closing a hole in a blood vessel. [Figure 26G]FIG. 13 is a schematic, partially cut-away perspective view of step (g) of seven steps in the overall procedure for closing a hole in a blood vessel. [Figure 27] FIG. 1 illustrates a hole in a patient's blood vessel and closure with transverse surgical sutures. [Figure 28] FIG. 1 illustrates the closure of a hole in a patient's blood vessel by a crossover surgical procedure. [Figure 29] 1 illustrates a hole in a patient's blood vessel and its closure by a longitudinal surgical procedure. [Diagram 30] FIG. 1 illustrates a perspective view of a closure device in one embodiment. [Figure 30A] FIG. 31 shows the closure device of FIG. 30 in front view. [Diagram 31] FIG. 13 shows a front view of a closure device in another embodiment. [Figure 31A] FIG. 32 shows a perspective view of the closure device of FIG. 31. [Diagram 32] FIG. 13 shows a front view of a closure device in another embodiment. [Figure 32A] FIG. 33 shows a perspective view of the closure device of FIG. 32. [Diagram 33] FIG. 1 illustrates a perspective view of a portion of a medical device according to one embodiment of the present invention. [Figure 33A] FIG. 34 is a substantially front view of the medical device of FIG. 33. [Diagram 34] 13A-13C are perspective views of portions of another embodiment of a medical device. [Diagram 35] 13A is a side view of a portion of another embodiment of a medical device. FIG. [Diagram 36] FIG. 1 is a highly simplified view of a front end view of a medical device. [Figure 37A] 11A-11C show, in different views, two additional exemplary embodiments of a closure device for use in embodiments of the present invention. [Figure 37B] 11A-11C show, in different views, two additional exemplary embodiments of a closure device for use in embodiments of the present invention. [Figure 37C]11A-11C show, in different views, two additional exemplary embodiments of a closure device for use in embodiments of the present invention. [Figure 37D] 11A-11C show, in different views, two additional exemplary embodiments of a closure device for use in embodiments of the present invention. [Figure 37E] 11A-11C show, in different views, two additional exemplary embodiments of a closure device for use in embodiments of the present invention. [Figure 37F] 11A-11C show, in different views, two additional exemplary embodiments of a closure device for use in embodiments of the present invention. [Figure 38] 1 illustrates a handle member that is part of an embodiment of a medical device according to the present invention with a guidewire advanced within a blood vessel. [Figure 39] 1A-1C show an embodiment of a retraction device actuated by a handle member. [Diagram 40] FIG. 13 shows three optionally parallel closure device holders pressed into holes by handle members. [Figure 40A] FIG. 41 shows a delivery support for the three parallel closure device holders of FIG. 40. [Figure 40B] FIG. 40B shows the delivery support of FIG. 40A in an expanded state. [Figure 40C] FIG. 13 shows a sleeve having a guide slot as an insert or part of the handle member. [Diagram 41] FIG. 13 shows three closure devices contained within a closure device holder and pushed forward by a mechanism on a handle member. [Diagram 42] FIG. 42 shows the three closure device holders of FIG. 41 being pulled back by a mechanism on the handle members. [Diagram 43] 13A-13D illustrate the release of the retraction device from the entry site by a mechanism on the handle member. [Diagram 44] 13A-13C show the retraction device and the mechanism of the handle member for fully removing or removing the medical device from the entry site. [Diagram 45]1A-1C show designs of retraction and engagement devices in an exemplary embodiment. [Figure 46A] 13 is a schematic diagram of an alternative embodiment of a retraction unit of a medical device according to the present invention. [Figure 46B] 13 is a schematic diagram of an alternative embodiment of a retraction unit of a medical device according to the present invention. [Figure 46C] 13 is a schematic diagram of an alternative embodiment of a retraction unit of a medical device according to the present invention. [Figure 46D] 13 is a schematic diagram of an alternative embodiment of a retraction unit of a medical device according to the present invention. [Figure 46E] 13 is a schematic diagram of an alternative embodiment of a retraction unit of a medical device according to the present invention. [Figure 47A] 46D shows an additional exemplary embodiment of a closure device holder for the retraction device shown in FIG. 46C. [Figure 47B] 46D shows an additional exemplary embodiment of a closure device holder for the retraction device shown in FIG. 46C. [Figure 47C] 46D shows an additional exemplary embodiment of a closure device holder for the retraction device shown in FIG. 46C. [Figure 48A] FIG. 13 shows a connector with openings for a retraction device holder and a closure device holder. [Figure 48B] FIG. 13 shows a connector with openings for a retraction device holder and a closure device holder. [Figure 49] FIG. 2 illustrates a perspective view of a portion of a medical device according to another embodiment of the present invention. [Figure 49A] FIG. 50 is a view substantially from the side of the medical device of FIG. 49. [Figure 50] FIG. 1 illustrates a perspective view of a closure device in one embodiment. [Figure 50A] FIG. 51 shows a perspective view of the closure device of FIG. 50. [Figure 51] FIG. 1 shows a closure device according to the present invention in a first state. [Figure 51A] FIG. 52 shows the closure device of FIG. 51 in a second state. [Figure 51B] FIG. 52 shows the arms of the closure device of FIG. 51 separated from each other. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0257] Certain embodiments of the present disclosure are directed to vascular closure devices and methods for closing a hole in tissue, such as a vascular closure device comprising a tissue retraction unit and a hole closure member.

[0258] (Organizational Pull-in) In one aspect of the invention, a retraction unit is provided for retracting two opposing portions of a tissue hole. After two arms, sides, etc. are deployed on opposing sides of the hole to close, the distance between the arms, sides, etc. is increased to retract the opposing sides, changing the shape of the tissue opening (hole) to a slit in which the two long straight sides of the hole are brought closer together in preparation for closing.

[0259] Those skilled in the art will appreciate that vascular closure as described herein follows the principles of surgical vascular closure techniques to prevent narrowing or stenosis of the blood vessel to be treated. The retraction device prepares the hole in the tissue to be a transverse slit perpendicular to the long axis of the blood vessel, comparable to an open surgical transverse suture. Circular retraction of the hole, such as an open surgical cross-stitch procedure or a longitudinal suture, is prevented to avoid stenosis of the blood vessel to be treated (see FIG. 27).

[0260] (Hole Closure) Another aspect of the present invention relates to a closure member for closing a hole in tissue prepared with a retraction unit. It should be appreciated that the retraction unit and closure member are not limited to vascular repair, but may be used for general tissue repair. Throughout the following description, it will be understood that the closure device of the medical device can be made of any biocompatible and / or bioabsorbable material, including, for example, titanium (and titanium alloys), nitinol, stainless steel, polymeric materials (synthetic and / or natural), ceramics, and the like. It will also be apparent from the description that the closure device has a needle shape, preferably in the form of a loop or circle, made of a deformable shape memory alloy, for example nitinol. As a general overview, the closure device of the present invention undergoes two deformation positions, a first position in a compressed linear configuration in which the closure device is captured in a closure device holder and deployed into the hole, and a second expanded circular configuration in which the closure device approximates the ends of the hole and closes the perforation in the tissue.

[0261] After a hole in the tissue is prepared by a retraction device to form a slit, the two long sides of the slit are connected by a closure device to close the opening in the tissue.

[0262] FIG. 1 is a side view of a retraction unit 100 of the present invention. The retraction unit 100 optionally has a longitudinal hollow retraction device holder 102 with a distal tip 110. The retraction device 101 is folded and captured within the tubular retraction device holder 102. The retraction device 101 has at least one or one proximal end 111 and two distal ends 112. The retraction device 101 is optionally made of a material with a memory effect and has the ability to extend the two distal ends 112 like a spring. The retraction device 101 may be formed from a shape memory alloy, for example Nitinol, formed in an expanded stage or state as a triangle that can be compressed to be captured within the retraction device holder 102. When the retraction device holder 102 is retracted along the arrow 108, the retraction device 101 is released in stages and the distal ends 112 gradually unfold due to the memory effect of the retraction device 101.

[0263] 2 is a side view of an alternative embodiment of the retraction unit 100 as shown in FIG. The retraction unit 100 has a longitudinal hollow retraction device holder 102 with a distal tip 110. The retraction device 101 is folded and captured in the tubular retraction device holder 102. In this embodiment, the retraction device holder 102 in cross section has grooves 207 in which the arms of the retraction device 101 are captured and guided when the retraction device 101 is moved longitudinally, in particular towards the distal end of the retraction device holder 102. The retraction device 101 is pushed towards the distal end 110 of the retraction device holder 102, for example, by a piston 203, optionally captured in the retraction device holder 102. The retraction device 101 is looped by an optional suture 202 that anchors the retraction device 101. The piston 203 in cross section has a groove 204 in which the suture 202 is captured. When the piston 203 is pushed longitudinally from FIG. 2C to FIG. 2E, the retraction device 101 is released in stages (FIG. 2C to FIG. 2F) and the memory effect of the retraction device 101 causes the distal end 112 to gradually widen. The retraction device 101 remains connected to the piston 203 by the anchoring suture 202 or a similarly acting component while being pushed longitudinally by the piston 203 towards the distal end 110 of the retraction device holder 102 or while being pulled away from the distal end 110 of the retraction device holder 102. Once the retraction device 101 is fully released, the retraction device holder 102 including the piston 203 may be removed leaving the retraction device 101 still anchored by the suture 202. Later, the retraction device 101 can be removed from its location (hole) by pulling on both ends of the suture 202 .

[0264] FIG. 3 is a schematic partial cross-sectional view of retraction unit 100 positioned within a lumen 302 in a blood vessel.

[0265] The retraction unit 100 has been developed so that it can be deployed through a wound inside a patient's body through a casing that features extending from outside the patient's body with its distal end within the lumen of a blood vessel 301 through a hole 302 to be closed.

[0266] The retraction unit 100 and retraction device 101 vary in size depending on the size of the hole 302 to be closed and the size of the patient's blood vessel 301 or other body organ, as well as on the material composition of the unit and device.

[0267] A retraction unit 100 having a retraction device holder 102 and capturing a retraction device 101 is inserted into a hole 302 in a blood vessel 301. Once a distal end 110 of the retraction device 101 is positioned below the vessel wall hole 302, the retraction device holder 102 is incrementally withdrawn (from FIG. 3A to FIG. 3D) away from the vessel hole 302 and the retraction device 101 is released. Due to the memory properties of the retraction device 101, the hole 302 is gradually widened in a direction perpendicular to the vessel long axis from FIG. 3B to FIG. 3D, resulting in the slit opening 302 of FIG. 3D in the vessel wall 301.

[0268] 4 is a side view of an alternative embodiment of the retraction unit 100 as shown in FIG. The retraction unit 100 has a longitudinal hollow retraction device holder 102 with a distal tip 110. The retraction device 101 is folded and captured in the tubular retraction device holder 102. The retraction device 101 has a proximal end 111 and two distal ends 112 with an optional engagement device 410 at each of the two distal ends 112. The engagement device 410 is preferably a loop-like element, preferably a wire loop, which can be initially formed in an expanded state and folded and captured in the retraction device holder 102. The retraction device 101 is optionally made of a material with a memory effect, such as a memory alloy, e.g., Nitinol, and has the ability to unfold the two distal ends 112 and deploy the wire loop 410. When the retraction device holder 102 is retracted along the arrow (Figures 4B to 4D), the retraction device 101 is released in stages, the two arms 112 of the retraction device 101 spread apart, and the distal engagement member 410 deploys due to the memory effect of the retraction device 101.

[0269] FIG. 5 is a schematic, partially cross-sectional side view of retraction unit 100 positioned within lumen 302 of blood vessel 301.

[0270] The retraction unit 100 has been developed so that it can be deployed through a wound inside a patient's body through a casing that features extending from outside the patient's body with its distal end within the lumen of a blood vessel 301 through a hole 302 to be closed.

[0271] The retraction unit 100 and retraction device 101 vary in size depending on the size of the hole 302 to be closed and the size of the patient's blood vessel 301 or other body organ, as well as on the material composition of the unit and device.

[0272] The retraction unit 100, which has a retraction device holder 102 and captures the retraction device 101, is inserted into the hole 302 of the blood vessel 301. The retraction device 101 has a proximal end 111 and two ends 112, with an engagement member 410 at each of the two ends 112. The engagement member 410 is preferably a wire loop that can be folded and captured in the retraction device holder 102. Once the distal end 110 of the retraction device holder 102 is positioned below the vessel wall hole 302, the retraction device holder 102 is pulled out in a stepwise manner (from FIG. 5A to FIG. 5B) in a direction away from the vessel hole 302, which opens below the vessel hole 302 and releases the engagement device 410 (FIG. 5D) which engages with the vessel inner wall surrounding the opening. The engagement device 410 is further released from FIG. 5B to FIG. 5C. The memory property of the engagement device 410 causes the hole 302 to gradually widen (from FIG. 5B to FIG. 5D) into a slit opening 302 (FIG. 5D) in the vessel wall 301. The open engagement device 410 prevents the engagement device 410 from being pulled out of the vessel hole 302 when in the slit configuration.

[0273] 6 is a front view of a closure device 600 of the present invention in a preferred form of a circular needle. The closure device 600 has a proximal end 602 and first and second arms 604, each having an optionally pointed distal end 603. Both arms 604 are bending portions of the closure device 600.

[0274] The closure device 600 has an expanded, substantially closed position (FIG. 6A) in which both arms 604 optionally or substantially form a half circle or semicircle, respectively, in one plane, allowing both arms 604 to cross each other, and in contrast, a compressed, substantially closed position (FIG. 6B) in which the arms 604 are substantially straight, allowing the closure device 600 to be captured in the retraction device holder 102 (FIG. 5) or closure member 800.

[0275] The closure device 600 may be made from a variety of pre-set memory shape materials, with the selection of materials depending on the particular need.

[0276] The closure device 600 may be made of any biocompatible material, including, for example, titanium (and titanium alloys), nitinol, stainless steel, polymeric materials (synthetic and / or natural), ceramics, etc., and / or bioabsorbable materials, such as galvanic corrosion, may be utilized. The degradation rate may be adjusted by the composition not forming any macroscopic bubbles. The closure device 600 is preferably made of a shape memory alloy, such as nitinol, and has the ability to form a loop-like structure. The size of the closure device 600 depends on the material composition of the needle and the size required for use. Depending on the application, the closure device 600 can have dimensions and cross-sectional dimensions ranging from 10 micrometers to 10 centimeters. The size depends on the target closure size and the size of the hole 302 to be closed.

[0277] Preferably, the expanded loop closure device 600 (FIG. 6A) may be resiliently compressed into its compressed state (FIG. 6B), for example, by constraining it with a closure member 800 as shown in FIG. 8.

[0278] The closure device 600 may be deployed from a contracted state (FIG. 6B) to an expanded state as shown in FIG 6A. When in a partially expanded state, the closure device 600 can be used like an anchor to locate it by withdrawing the partially expanded closure device 600 in the hole 302 to be closed until the hook-shaped closure device 600 pierces the wall, further withdrawal can be detected as an increase in resistance to further withdrawal (as shown in FIG 13F).

[0279] The closure device 600 has a pointed end 603 that engages one side of the hole wall surrounding the opening 302 and penetrates the wall of the hole 302, with anchor-like bent arms 604 approximating the perforated tissue wall as shown in Figure 7. A groove 602 in the expanded closure device 600 (see Figure 6A), which represents the proximal end 602 of the closure device 600 in Figure 6B, allows for locking of the closure device 600 to a closure member 800, as shown below in Figure 13.

[0280] FIG. 7 is a side view of the closure device 600 shown in FIG. 6 deployed into the hole 302 , penetrating tissue 301 and connecting the free edges of the hole 302 .

[0281] FIG. 7 illustrates the subsequent deployment of the closure device 600 from FIG. 6 within the hole 302 to be closed.

[0282] In FIG. 7A, closure device 600 (as shown in FIG. 6) is in a compressed, straightened configuration and advanced into hole 302 in tissue 301.

[0283] In FIG. 7B, the closure device 600 is partially deployed and the tip of the closure device 603 is bent due to a memory material effect.

[0284] In FIG. 7C, where the closure device 600 is further deployed, the end of the closure device 603 is further bent into an anchor configuration 708, with the pointed end of the closure device 603 engaging one side of the tissue hole 301 and penetrating the wall 301 (see 709).

[0285] The closure device 600 is then withdrawn and the pointed end 722 of the anchor-shaped closure device 708 pierces the tissue 301. Further deployment of the closure device 600 causes both bent arms to each complete a half circle or semicircle, approximating the ends of the hole in the tissue and closing the hole 302.

[0286] However, it should be understood that deployment of the closure device 600 optionally requires a closure device holder 802, as shown in subsequent Figures 8-12. It should be understood that more closure devices 600 may be utilized depending on the embodiment and configuration of the closure device 600.

[0287] 8 is a schematic cross-sectional side view of a closure member 800 in a longitudinal direction 801, comprising a longitudinal hollow closure device holder 802 having a distal end 804. The closure device holder 802 contains a linear compressed closure device 600 therein. The closure device holder 802 optionally has a transverse channel 803 for deploying the closure device 600.

[0288] 9 is a schematic cross-sectional perspective side view indicated by arrow 801 of the closure device holder 802 shown in FIG. 8 including a linearly folded closure device 600. The closure device holder 802 optionally has a lateral channel 803 for deploying the closure device 600. The channel 803 allows the closure device 600 to exit the closure device holder 802 in a flexed manner, as shown in FIGS. 12B-12D in the form of an anchor 708 (FIG. 12C), but prevents the closure device 600 from engaging structures and tissues that may be located opposite the end 804 of the closure device holder 802, such as the opposing vessel wall.

[0289] 10 is a schematic partial cross-sectional perspective view, indicated by arrow 801, of blood vessel 301 and closure device holder 802, including straight folded closure device 600 therein, being advanced into blood vessel lumen 1006 through hole 302 in blood vessel wall 301, as shown in FIGURES 8 and 9. Channel 803 in distal closure device holder 802 allows closure device 600 to exit closure device holder 102 in a curved manner, as shown in FIGURES 12B-12D, in the form of anchor 708 (FIGURE 12C) that prevents closure device 600 from engaging the opposing blood vessel wall 301.

[0290] 11 is a schematic partial cross-sectional perspective view indicated by arrow 801 of a longitudinal section of a blood vessel 301 and a closure device holder 802 as shown in FIGS. 8, 9, and 10, containing a straight, compressed closure device 600 deployed through a hole 302 in the vessel wall 301 into the vessel lumen 1006. A channel 803 in the distal closure device holder 802 allows the closure device 600 to exit the closure device holder 102 in a curved manner as shown in FIGS. 12B-12D, e.g., in the form of an anchor 708 (FIG. 12C) that prevents the closure device from engaging the opposing vessel wall 301.

[0291] FIG. 12 is a schematic partial cross-sectional longitudinal cross-sectional view of the closure device holder 802 of FIGS. 8 and 9 in the sequence of FIGS. 12A to 12E, as indicated by arrow 801, showing the closure device holder 802 from FIG. 8 deployed into the hole in FIG. 12A.

[0292] In FIG. 12B, the closure device 600 is pushed outward toward the end 804 of the closure device holder 802 , causing the tip of the closure device 603 to bend away from the closure device holder 802 within the channel 803 .

[0293] 12C, the closure device 600 is pushed further towards the end 804 of the closure device holder 802 and through the channel 803, further leaving the closure device holder 802, optionally forming an anchor 708. The tip 603 of the closure device 600 engages the vessel wall 301.

[0294] In FIG. 12D, the closure device holder 802 is pulled further out of the hole 302. The anchor 708 has a pointed end 722 that pierces the vessel wall 301. Further withdrawal can be detected as a firm resistance to further withdrawal. The closure device holder 802 is then pulled further out of the vessel hole 302 and the closure device 600 is released. The arms 604 of the closure device 600 bend inward, pulling the ends of the hole 302 together, closing the hole 302 and forming a ring structure as shown in FIG.

[0295] Fig. 13 is a schematic partial cross-sectional longitudinal section view of an alternative closure member 800 disposed within a hole 302 in a wall 301 of a blood vessel. Fig. 13 illustrates the sequence of Figs. 13C-13H of deployment of the closure device 600 and closure of the hole 302 achieved by the closure device 600. In this embodiment, the closure member 800 captures the piston 203.

[0296] 13A shows in cross section a retention device 202, preferably a piston 203 having a groove 204 along which the suture is guided. The retention device 202 anchors the closure device 600 to connect the piston 203 to the closure device 600.

[0297] 13B shows in cross section the closure device holder 802 shown in FIG. 8 having grooves 207 in which the arms of the closure device 600 are captured and guided as the closure device 600 is moved longitudinally, particularly in a direction toward the distal end 804 of the closure device holder 802. The closure device 600 is pushed toward the end 804 of the closure device holder 802 by the piston 203, as shown in the sequence of FIG. 13C through FIG. 13H.

[0298] 13C, an end of closure member 800 is deployed into hole 302 in wall of blood vessel 301. Closing member 800 and closure device 600 are oriented longitudinally of blood vessel 301, as shown in FIG.

[0299] 13D, the piston 203 is pushed towards the distal end 804 of the closure device holder 802, causing the tip of the closure device 600 to bend outward, exiting the closure device holder 802 through the channel 803. The retention device 202 follows the forward movement of the closure device holder 802 towards the end 804, while maintaining a rigid connection between the closure device 600 and the piston 203.

[0300] 13E, the closure device 600 is pushed further by the piston 203 toward the distal end 804 of the closure device holder 802 and further away from the closure device holder 802 through the channel 803 to form an anchor 708. The tip 603 of the closure device 600 engages and penetrates the vessel wall 301.

[0301] 13F, the closure device holder 802 is withdrawn together with the closure device 600, and the pointed end 603 of the partially released closure device 600 formed like an anchor 708 pierces the vessel wall 301 (see 722). Further withdrawal of the anchor-like closure device 600 can be detected as a firm resistance to further withdrawal.

[0302] Pushing the piston 203 further toward the end 804 of the closure device holder 802 causes the closure device 600 to complete a half circle or semicircle with each of both arms 604, approaching the end of the hole in the tissue and somewhat closing the hole 302 like a single suture to close the hole 302 as shown in FIG. 13H.

[0303] Once the closure device 600 is released, the closure device holder 802 including the piston 203 is removed, with the open closure device 600 still tethered by the holding device 202. The holding device 202 may then be utilized to deploy or further retract the closure device 600, as needed. When the result of the closure of the hole 302 is satisfactory, the holding device 202 is removed, for example, by pulling on one arm of the holding device 202.

[0304] The following description combines the retraction unit 100 and the closure members 800 in a set or medical device, deployed simultaneously or subsequently. The sequence of Figures 14 to 21 shows the closure of the hole 302 with two closure members 800.

[0305] Figure 14 is a schematic partial cross-sectional perspective view of an alternative embodiment of the retraction unit 100 shown in Figure 5. The retraction unit 100 has two retraction device holders 102, each capturing one retraction device 101 with an engagement device 410 distally connected thereto.

[0306] The engagement device 410 is preferably a wire loop that can be folded and captured within the retraction device holder 102 .

[0307] The distal ends 110 of the two retraction device holders 102 are deployed on opposite sides of a hole 302 in tissue 301 .

[0308] 15 is a schematic partial cross-sectional perspective view of two retraction devices 101 in a hole opening 302 with ends 110 positioned on opposite sides of the hole 302 below the hole wall 1411. The retraction devices 101 have been pushed forward to their distal ends 110. The engagement devices 410 are now clear of the openings at the distal ends 110 of the retraction device holders 102, and the engagement devices 410 are looped open.

[0309] 16 is a schematic partial cross-sectional perspective view of two retraction units 100 within a bore opening 302 with distal ends 110 positioned on opposite sides of the bore 302 below the bore wall 1411. The two retraction device holders 102 with engagement devices 410 are moved in opposite directions as indicated by arrows 1420.

[0310] FIG. 17 is a schematic partial cross-sectional perspective view of two retraction devices 101 positioned in the hole opening 302 with their distal ends 110 positioned on opposite sides of the hole 302 below the hole wall 1411. The two retraction devices 101 are moved in opposite directions as indicated by arrows 1420 to form a slit in the hole 302. The opposite movement of the retraction devices 101 comes to a halt when the hole opening 302 forms a straight slit, for example when the length of the slit is equal to half the circumference of the hole 302 as shown in FIG. 15. The engagement device 410 forms a loop with a diameter larger than the minor axis of the slit opening of the hole 302 at a 90 degree angle 1422 to the slit opening. The engagement means 410 locks the retraction units against accidental upward movement 1421 as indicated by arrows 1420. The upward movement 1421 of the retraction device 101 is stopped when the engagement device 410 contacts and cannot pass through the slit opening of the hole 302 .

[0311] 18 is a schematic partial cross-sectional perspective view of two retraction devices 101 and two engagement devices 410 positioned within a hole opening 302 as shown in FIG. 16 with simultaneous or sequential deployment of closure members 800 to convert the hole into a slit configuration, with two closure device holders 802 between the hole shoulders and ends 804 and channels 803 positioned below the hole opening 302. The closure device 600 is captured and compressed within the closure device holders 802 and oriented at a 90 degree angle relative to the hole opening 302 as indicated by the protractor 1722 and arrow 801.

[0312] 19 is a schematic partial cross-sectional perspective view of two retraction devices 101 with the engagement device 410 and closure device holder 802 positioned within the hole opening 302 as shown in FIG. 18. The closure device 600 is released stepwise in the direction of the closure device holder end 804, moving away from the closure device holder 802 within the channel 803, engaging the wall of the tissue 301 surrounding the opening 302 and the tip 603 of the closure device 600, forming an anchor 708 that perforates the wall of the tissue 301 as shown by perforation 722. Further retraction can be detected as a firm resistance to further retraction. The closure device holder 802 is then further retracted out of the vessel hole 302 to release the closure device 600.

[0313] 20 is a schematic partial cross-sectional perspective view of two retraction device holders 102 partially retracted from holes 302 while engagement devices 410 are still disposed within holes 302. The closure device holder 802 as shown in FIG. 19 is removed. The closure device 600 as shown in FIG. 19 is fully opened to form the configuration as shown in FIG. 6A. The closure device 600 approximates and closes the free edges 1411 of holes 302.

[0314] 21 is a schematic perspective view of tissue 301 having a closed hole 302. The sides of the hole 302 have been approximated and closed by a closure device 600 that perforates the tissue as indicated by perforations 722.

[0315] The following description combines the retraction unit 100 and the closure member 800 in a set or medical device that are deployed simultaneously within a blood vessel 301. The sequence of Figures 22 through 25 illustrates the closure of a hole 302 in tissue with one closure device 600.

[0316] 22 is a schematic partial cross-sectional perspective view of two retraction devices 101 with an engagement device 410 and one closure device holder 802 deployed in a hole 302 in the wall 2204 of a blood vessel 302 in a blood vessel lumen 1006. The engagement device 410 is positioned inside the blood vessel lumen 1006 oriented in the longitudinal direction of the blood vessel 301 as indicated by arrow 801. At the same time, the closure device holder 802 is deployed between the retraction devices 101 with the opening of the channel 803 below the wall 2204 of the hole inside the blood vessel lumen 1006 oriented in the longitudinal direction of the blood vessel 301 as indicated by arrow 801.

[0317] 23 is a schematic partial cross-sectional perspective view of two retraction devices 101 with an engagement device 410 and one closure device holder 802 deployed into a hole 302 in the wall 2204 of a blood vessel 302. The channel 803 of the engagement device 410 and retraction device holder 102 is positioned below the wall 2204 of the hole inside the blood vessel lumen 1006. The retraction device 101 and engagement device 410 are moved apart laterally perpendicular to the long axis of the blood vessel. The engagement device 410 presses against the inner wall of the blood vessel 301 in opposite directions. This retracts the opposing sides of the hole 302, widening the hole 302 in the blood vessel 301 in a direction perpendicular to the long axis of the blood vessel 301 while simultaneously bringing the opposing expanded long sides of the hole 302 closer together.

[0318] 24 is a schematic partial cross-sectional perspective view of two retraction devices 101 with an engagement device 410 and one closure device holder 802 deployed into a hole 302 in a wall 2204 of a blood vessel 301. The engagement device 410 and the channel 803 of the retraction device 101 are positioned below the wall 2204 of the hole inside the blood vessel lumen 1006. The retraction device 101 and the engagement device 410 retract the hole 302 in a direction perpendicular to the long axis of the blood vessel 301, approximating the opposing elongated long sides of the hole 302. The closure device 600 is partially deployed and disengages from the closure device holder 802 via the channel 803, sufficiently gripping the vessel wall 2204 as indicated by the perforations 722 to form an anchor 708 penetrating the vessel wall 2204. Further retraction can be detected as a firm resistance to further retraction. The closure device holder 802 is then withdrawn further from the vascular hole 302 and the closure device 600 is released, forming a complete circular structure, pulling the hole walls 2204 and drawing the extended long sides 2204 of the hole further together. Finally, the closure device holder 802 is withdrawn and removed, and the retraction device 101 is removed by pulling the engagement device 410 out of the closed hole 302 while the flexible loop of the engagement device 410 collapses and passes through the shoulder of the already closed hole 302.

[0319] FIG. 25 is a schematic partial cross-sectional perspective view of a blood vessel 301 having a hole 302 closed by a closure device 600 at a fenestrations 722 in the wall 2204 of the hole in a straight line perpendicular to the long axis of the vessel.

[0320] FIG. 26 is a schematic partial cross-sectional view from an operator's perspective showing the closure of a hole 302 in a patient's blood vessel.

[0321] In FIG. 26B, a retraction unit 100 having two arms and a closure member 800 having three closure device holders 802 are placed into the opening 302 in the patient's blood vessel.

[0322] 26C, the engagement devices 410 are moved apart laterally perpendicular to the long axis of the vessel on opposite sides of the hole 302, retracting the sides of the hole 302, thereby bringing the upper and lower ends of the hole 302 closer together and forming a slit opening having two long sides, distal and proximal, and two short sides on the sides of the vessel. At the same time, the closure device holders 802 are moved apart so as to be evenly distributed along the widened hole 302.

[0323] In FIG. 26D, the closure devices 600 are deployed, each forming an anchor.

[0324] In FIG. 26E, the closure device holder 802 is withdrawn and the closure device 600 is engaged, and as the closure device holder 802 is withdrawn, the wall of the blood vessel 301 surrounding the opening 302 is perforated.

[0325] Further withdrawal may be detected as a firm resistance to further withdrawal. The closure device holder 802 is then withdrawn further from the vascular hole 302 and the closure device 600 is released.

[0326] In FIG. 26F, the closure device 600 has been deployed to form circular needles closing off the holes 302.

[0327] 26G, the engagement device 410 is retracted. The closure device 600 closes the lateral seam of the hole 302.

[0328] 27 is a surgeon's view of a hole 302 in a patient's blood vessel 301 showing the open surgical closure of the hole 302 with a suture. The hole 302 in the patient's blood vessel 301 is closed in a straight line perpendicular to the long axis of the vessel, with the suture 2600 extended or interrupted to avoid stenosis of the patient's blood vessel. This principle of closing a hole in a patient's blood vessel is particularly important and is realized in the present invention as shown in Figures 10-12 and 22-26 which illustrate an exemplary method of operating the medical device.

[0329] 28 is a surgeon's view of a hole 302 in a patient's blood vessel 301 showing the open surgical closure of the hole 302 with sutures 2600. The hole 302 in the patient's blood vessel 301 is closed with cross sutures, or equally with purse string sutures (not shown), which approximate the sides of the hole 302. The approximation of the sides of the hole 302 causes narrowing of the vessel lumen as indicated by arrow 2700.

[0330] 29 is a surgeon's view of hole 302 in a patient's blood vessel 301 showing open surgical closure of hole 302 with sutures 2600. Hole 302 in a patient's blood vessel 301 is closed with longitudinal sutures. Lateral approximation of hole 302 has caused narrowing of the vessel lumen as indicated by arrow 2700.

[0331] Only lateral closure perpendicular to the long axis of the blood vessel, as shown in Figures 27, 10-12, and 12-26, brings the proximal and distal ends of hole 302 closer together and simultaneously widens the lateral ends of hole 302, avoiding narrowing of the blood vessel diameter and lumen.

[0332] 30 shows in perspective view a closure device 600 in one embodiment, which comprises two arms 604, each having an optionally pointed end 603. The arms originate from a curled or curved portion 605.

[0333] FIG. 30A shows the closure device 600 of FIG. 30 in a front view.

[0334] 31 further illustrates a front view of a closure device 600 in one embodiment, which includes two arms 604, each having an optionally pointed end 603. There are no curled or curved portions.

[0335] FIG. 31A shows the closure device 600 of FIG. 31 in a perspective view.

[0336] Figure 32 shows a front view of a closure device 600 in one embodiment, which comprises two arms 604, each having an optionally pointed end 603. In contrast to the embodiment of Figure 30, the curled or curved portion 605 is not closed, meaning that there is no helical portion.

[0337] FIG. 32A shows the closure device 600 of FIG. 32 in a perspective view.

[0338] 33 illustrates in perspective view a portion of a medical device according to the present invention. Guidewire 1000 is introduced into lumen 1006 of blood vessel 301. Guidewire 1000 is advanced through a central opening in the medical device extending therethrough, designated as guidewire lumen 115.

[0339] The two engagement devices 410 draw the hole 302 into a slit.

[0340] The retraction unit is not shown in Figure 33. If a retraction unit is shown, it may be positioned so that it can be advanced through the guidewire lumen 115, as shown in Figure 35 for another embodiment of the medical device.

[0341] Although not shown in the figures, the medical device, particularly the engagement device 410 or the retraction device 101, may comprise a portion that prevents the guidewire 1000 from interfering with the closure device. This portion may be a wire structure that guides the guidewire out of the range of the closure device 600.

[0342] FIG. 33A shows the medical device of FIG. 33 from the front.

[0343] Fig. 34 shows parts of another embodiment of the medical device in a perspective view. The engagement device 410 is composed of a single wire. As can be seen in Fig. 34, the retraction device 101, or any other part of the medical device that is inserted into the vessel lumen during use, may in any embodiment comprise a step or bend 420 that may interact with the hole 302 or the wall of the vessel 301 to provide tactile feedback to the surgeon when the medical device is retracted from the vessel 301. If and when the surgeon feels the tactile feedback, the surgeon is confident that the medical device is ideally positioned relative to the hole 302 to close the hole by releasing the closure device 600.

[0344] Fig. 35 shows parts of yet another embodiment of a medical device from the side. Fig. 35 shows substantially what is also revealed in Fig. 33 or Fig. 33A. However, it also shows in a very schematic manner two closure devices 600 closing the hole 302. The engagement device 410 must still be folded and pulled out of the vessel lumen 1006.

[0345] 36 shows a highly simplified view on the front end of a medical device in yet another embodiment, having a longitudinal axis L and a casing 117. As can be seen, the end of the medical device has several openings: one to accommodate a guidewire 1000, one to accommodate two retraction devices 101 and one to accommodate four closure devices 600.

[0346] It goes without saying that the number of openings, retraction devices 101, and closure devices 600 are not limited to the numbers shown in Fig. 36. Also, the guidewire 1000 may extend through an opening dedicated to the guidewire 1000. However, it may also share its opening with one or more retraction devices 101 and / or closure devices 600.

[0347] 37A-37F show two additional exemplary embodiments of a closure device 600 in different views.

[0348] Figures 37A-C show one of these additional embodiments in different views. Figure 37A shows a perspective view, Figure 37B shows a front view, and Figure 37C shows a side view. The two arms 604 of the wireform closure device 600 are optionally mated together at a non-curved portion 607. The mating can be achieved by soldering, gluing, friction welding, or in another way. Alternatively, the two arms 607 are integral with each other, i.e., not joined to each other.

[0349] Additionally, the non-curved portion 607 (where the closure device 600 is not curved in its fully deployed state) is merely a part of some embodiments and is therefore not limiting.

[0350] The curved portion 605 is generally ring-shaped when viewed from the front (FIG. 37B) and does not exhibit a pivot point, in contrast to the curved portion 605 of the embodiment of FIGS. 37D-37F, as discussed in more detail below. Thus, the left arm 604 always veers or is always bent to the left (see FIG. 37B) and the right arm 604 always veers or is always bent to the right.

[0351] The end profiles or portions of the arms 604 in the embodiment of Figures 37A-37C are optionally beveled into sharp ends 603 so that they can easily penetrate the wall of a blood vessel.

[0352] The closure device 600 is preferably manufactured from a memory material such as Nitinol, whereby starting from an original more or less straight shape that the closure device 600 assumes or adopts when the closure device 600 is positioned inside the closure device holder 802, a ring shape is spontaneously assumed or adopted by the closure device 600 once released or placed within a blood vessel.

[0353] In Figures 37D-37F, yet another embodiment of a closure device 600 is shown in a different view similar to that of Figures 37A-37C.

[0354] 37A-37C, a first portion of each arm 604 near or adjacent to the straight or non-curved portion 607 of the arm 604 is bent in a first bending direction away from the non-curved portion 607 or the other arm 604. The bending angle may be between 60° and 120°, preferably between 80° and 100°, and most preferably 90° (degrees) in the first bending direction.

[0355] The second section following the first section may optionally be bent approximately 360 degrees. It may be bent in a second bending direction opposite to the first direction (first to the left, then to the right, or vice versa). The end profile may be cut straight or nearly straight, as shown in Figures 37D-37F, or may be chamfered as in Figures 37A-37C. Again, the non-curved section 607 (not curved when the closure device 600 is in its fully used state) is only part of some embodiments.

[0356] Note that in the embodiment of Figures 37D-37F, both arms 604 may each have a first (or only one first) bend to the left and a second (or only one second) bend to the right.

[0357] Also, note that in the embodiment of Figures 37D-37F, end 603 of a first arm of arm 604 faces away from a second arm of arm 604, while end 603 of second arm 604 faces away from first arm 604.

[0358] As can be seen in Figures 37D-37F, the design of the closure device 600 in this embodiment allows the left arm 604 to capture tissue on the left side of the entry site. It can pull that tissue towards the right arm 604. Similarly, the right arm 604 is positioned to capture tissue on the right side of the entry site. It can pull that tissue towards the left arm 604.

[0359] This design has been shown to provide a closer and therefore more reliable closure of the vascular hole 302. Due to the tighter closure achieved, it appears that the set goal of closing the vascular hole 302 may be advantageously achieved with fewer closure devices 600 and / or by using smaller closure devices 600.

[0360] Optional straight or non-curved portion 607 can be separated to hold and / or push the closure device 600 until it is finally released. Also, portion 607 may be used to interconnect the two arms 604 to each other, for example in a welding process.

[0361] If fabricated from a shape memory material, the arms 604, once removed from the sheath, can begin to pull on tissue on opposite sides of the vascular opening 302.

[0362] 38 shows a handle member 900 of a medical device and a guidewire 1000 advanced into a blood vessel 301 (e.g., a vein) through a hole 302 in the blood vessel 301. The design and use of at least some of the handle member 900 and its mechanisms for pushing and advancing components such as the guidewire 1000, retraction device 101, etc. are described below.

[0363] FIG. 39 illustrates one embodiment of the retraction device 101 and engagement device 410 actuated by a handle member 900 .

[0364] In this embodiment, to activate or advance the retraction device 101, in a first step, the optional first slider 902 is pushed by the user in the direction marked by the corresponding arrow (towards the blood vessel 301).

[0365] Similarly, together with this first slider 902, an optional second slider 904 is also moved by the user, as indicated by another corresponding arrow (again toward the vessel 301). The function of the second slider 904 is described below.

[0366] At its end position or another position, the first slider 902 may optionally be locked in place. At the end of this first step, the retraction device 101 has not yet been expanded within the blood vessel 301 and has not yet engaged the entry site. However, the tips of the retraction device 101 are separated from each other.

[0367] In a second step, the handle member 900 is pulled back by the user, as indicated by the arrow shown next to the handle member 900 and pointing away from the blood vessel 301, until the user can feel the retraction device 101 fully engaged with its engagement device 410 at the entry site. In this state, the opposing edges of the slit opening 302 are closed together by the arms of the retraction device 101.

[0368] The optional designs of the retraction device 101 and engagement device 410 shown in this figure are further explained in FIG.

[0369] 40 shows (optionally three) closure device holders 802 being pushed towards holes 302 by a mechanism included in the handle member 900. The closure device holders 802 may be completely or only partially parallel to each other.

[0370] The act of pushing the closure device holder 802 out of the closure member 800 and / or handle member 900 may be actuated by an optional switch 906 or another mechanism on the handle member 900. The switch 906 is disposed so as to be movable within an opening 908 in a casing of the handle member 900.

[0371] In this first step, switch 906 is pressed up to a first stop, which may optionally be provided by the left edge of opening 908 (see the position taken by switch 906 in FIG. 40).

[0372] In this first step, by activating switch 906, the closure device holders 802 are expanded to their full width, meaning that they are placed, optionally approximately equidistant, along the holes 302. In FIG. 40, this is indicated by the three small arrows between the closure device holders 802 and the single or multi-lumen extrusion or opening 910. The closure device 600 is still inside the closure device holders 802.

[0373] It should be noted that the closure device holders 802 may remain parallel throughout the closure of the vascular hole 302 or may be positioned to diverge from one another. For example, they may be positioned such that adjacent closure device holders 802 can move at least partially away from one another when deployed. For example, they may be positioned such that there is a wider gap, space or distance between their tips when advanced towards the vascular hole 302.

[0374] Fig. 40A shows an optional delivery support 806 for three or more parallel closure device holders 802. In the still unexpanded state of Fig. 40A, which may be the state that the closure device holders 802 assume at the end of the first step as described in Fig. 40, the closure device holders 802 are only spaced apart from each other by a small distance. Their separation can be triggered by the design of the delivery support 806. The delivery support 806 may include or consist of a wire net or structure. The delivery support 806 may be a foldable and / or non-foldable element.

[0375] Optionally, bumpers 807 may be included on the exterior or sides of the closure member, closure device holder 802, or delivery support 806. These bumpers 807 are spacers as shown in FIG. 40B in the expanded or deployed state of the delivery support 806.

[0376] Figure 40B shows the delivery support 806 of Figure 40A in an expanded or deployed state. The delivery support 806 is opened by pushing it downwards as indicated by the arrow on the top of the pusher tube 808. This actuation spreads the closure device holders 802 and distributes them along the slit opening 302. To keep the distance between the lateral closure device holders 802 and the outer edge of the slit opening 302 small, the bumpers 807 act as spacers and can maintain this small distance during the closure of the vascular hole 302.

[0377] Figure 40C shows a sleeve 914, optionally with a U-shaped or V-shaped guide slot 916. The sleeve 914 is part of the handle member 900. In the guide slot 916, a pin or another protrusion of a knob 912 (see Figure 41), preferably arranged at the rear of the handle member 900, or another element connected to the knob 912, can be moved, as known for example from so-called tongue and groove systems.

[0378] The guide slot 916 comprises a first slot portion 916a and a second slot portion 916b, each connected to each other by another portion called a turning point 916c. At this turning point 916c, when the pin is moved along the guide slot 916 from its first slot portion 916a to its second slot portion 916b, or vice versa, it is first moved along the guide slot 916 in a clockwise direction about the longitudinal axis of the sleeve 914, and when it reaches the turning point 916c, it is moved counterclockwise, or vice versa. It should be noted that the pin may be part of the knob 912, while the guide slot 916 may be part of the sleeve 914, or vice versa.

[0379] Thus, when the knob 912 is rotated in a first direction (e.g., clockwise), the pin travels along the first slot portion 916a until it enters a turning point 916c of the guide slot 916 where the knob 912 stops rotating. The turning point 916c may therefore be understood as a stop.

[0380] To advance the sleeve 914 further relative to the knob 912 (or vice versa), the knob 912 must be rotated in a second direction (e.g., counterclockwise). A resilient element, i.e., a spring or the like, can ensure that the pin smoothly enters the second slot portion 916b when it reaches the turning point 916c and attempts to move away from the turning point 916c.

[0381] By providing the guide slot 916 as described above, the user (surgeon) can get tactile feedback indicating that a predetermined extension movement of the sleeve or pin has been achieved, especially if the guide slot 916 is U-shaped or V-shaped. Further extension movement can only be achieved by reversing the direction in which the knob is turned. This feature is therefore a safety measure. It can also increase precision in advancing an element such as the closure device 600.

[0382] 41 shows three closure devices 600 being pushed forward within the closure device holder 802 by a mechanism on the handle member 900. In this particular embodiment, the mechanism is actuated or manipulated by rotating a knob 912 at the rear end of the handle member 900 to advance the closure devices 600 to close the holes 302 and at least partially release the closure devices 600. This was mentioned in the above discussion of the optional V-shaped guide slots 912.

[0383] Figure 42 illustrates how the three closure device holders 802 are pulled back by the mechanism of the handle member 900. In particular, rotating the switch 906 in the opposite direction to that described in Figure 40 (hence, to the right in Figure 42) pulls the closure device holders 802 rearward, as indicated by the arrows toward the rear end of the handle member 900.

[0384] By the end of this step, the closure device 600 will have closed the holes 302 by piercing the edges of the holes 302 as it assumes its final shape. The final shape of the closure device 600 may be predetermined during the manufacture of the closure device 600, for example, by using a shape memory material such as Nitinol.

[0385] 43 shows the release of retraction device 101 from the tissue of hole 302 by a mechanism of handle member 900. This mechanism is optionally actuated or triggered by pulling back on second slider 904. This step separates the two parts of retraction device 101, allowing retraction device 101 to be pulled back and removed from blood vessel 301.

[0386] 44 shows the mechanism of the handle member 900 for complete removal of the retraction device 101. In this final step, the first slider 902 is pulled back to the rear of the handle member 900. Following this step, the entire handle member 900 system can be removed.

[0387] Figure 45 shows in an enlarged view an optional design of the retraction device 101 and the engagement device 410 shown, for example, in Figure 39. A cut along II is also shown in Figure 45.

[0388] In the exemplary embodiment of FIG. 45, the retracting device 101 of the retracting unit 100 comprises multiple (here two) arms, here arm 101a and arm 101b.

[0389] Arm 101a of engagement device 101 comprises two legs 121, 123. Leg 121 is referred to as the outer leg and leg 123 is referred to as the inner leg, and as in the retracted position of retraction device 101, leg 121 is more lateral than the more centrally located leg 123 (see FIG. 45).

[0390] Legs 121 and 123 may be welded to one another within or by weld 125 .

[0391] Distal to the weld 125, the legs 121, 123 may be spaced apart from one another to surround or circumscribe one or two intermediate openings 127, which may be trough openings.

[0392] The inner leg 121 may be straight or substantially straight, however, the outer leg 123 may be curved such that its outer side (side, see FIG. 45) is provided with a depression, bulge or indentation.

[0393] The depressions, bulges or indentations form the engagement device 410 already described above, which may be used to releasably engage tissue. For example, the engagement device 410 may provide tactile feedback to the surgeon when slightly withdrawing the medical device from the vessel hole 302 for proper placement relative to the vessel 301 or its hole 302.

[0394] Due to the particular shape of the engagement device 410, the arm 101a has the shape of a splint.

[0395] What has been said about arm 101a applies equally to arm 101b.

[0396] As can be seen in FIG. 45, the arms 101a and 101b exit the retraction unit 100 through separate openings 131 and 133, respectively, although the arms 101a and 101b may exit through a common opening.

[0397] As can be seen from the cut along line II, also shown in Figure 45, at least one of the openings 131 is designed to have a width that is smaller than the cross-sectional length of the arms 101a and 101b (e.g. in a cross section through the weld 125). For this purpose, the opening 131 or its opening area, or the specific shape of the gap in the retracting unit 100 that follows and ends with the opening 131, is longer (in the vertical direction of Figure 45) than it is wider (in the horizontal direction of Figure 45).

[0398] Such a shape can be achieved, for example, by selecting an elliptical shape for the opening 131 (or such a cross-section of the cavity behind it including the retraction device 101 during use or a portion thereof before being released), such as that shown in FIG.

[0399] Such a shape can prevent undesired twisting or rotation of the arms 101 a, 101 b (along their longitudinal axes) during use, particularly when the medical device is pulled back as a whole to place the medical device in a desired position for releasing the closure device 600. Preventing twisting or rotation of the arms 101 a, 101 b can contribute to maximizing retraction of the blood vessel hole 302.

[0400] Of course, any other solution making it possible to avoid twisting may additionally or alternatively be provided, for example pins, protrusions, etc. arranged to prevent twisting or rotation.

[0401] Fig. 46 is a schematic diagram of an additional exemplary embodiment of the retraction unit 100. In the sequence of Fig. 46A to Fig. 46C, different steps and views for placing the retraction device 101 in the hole 302 are shown and will be explained in detail below. Fig. 46D shows an alternative design of the deployment device 103.

[0402] FIG. 46A shows one embodiment of a retraction unit 100 comprising a retraction device holder 102 having a retraction device 101, and a deployment device 103 configured to slide within the retraction device holder 102 towards or up to a hole 302.

[0403] The retraction unit 100 can be inserted from outside the patient's body 303 through the patient's skin 304 to a hole 302 in a blood vessel 301 inside the patient's body 305. As shown in Figures 46A and 46B, a proximal end portion of the retraction device holder 102 is optionally placed outside the body 303. As shown in Figure 46B, after placing the retraction unit 100 together with the retraction device 101 in the hole 302, the proximal end portion of the retraction device holder 102 can be manually captured and secured so that the deployment device 103 can be retracted as indicated by the arrow.

[0404] The deployment device 103 is releasably disposed inside the retraction device holder 102 in this embodiment. The longitudinal axis L of the retraction device holder 102 and the longitudinal axis L of the deployment device 103 are coaxial and preferably identical, as in FIG. 46A. The cross-sectional shape of at least one of the retraction device holder 102 and the deployment device 103 is preferably circular or approximately circular. However, as can be seen in FIG. 46A, some parts, such as the distal end part of the retraction device holder 102, may be different, as shown in more detail in FIG. 46B, which reveals that the retraction device 101 comprises a first arm 135 and a second arm 137 forming the distal end part of the retraction device holder 102. The distal ends 112 of these arms 135, 137 are optionally spherical. The cross-section of at least one of the arms 135, 137 may be circular or rounded in shape.

[0405] The configuration of the retraction unit 100 shown in FIG. 46A is preferably used to move the retraction device holder 102 with its distal end portion 101 close to or within the hole 302. The outer diameter D of the retraction unit 100 Rcorresponds to the outer diameter of the retraction device holder 102 and / or to the width of the retraction device 101 at least in part.

[0406] The distal end portion and / or another portion of the deployment device 103 is preferably cone-shaped and may be configured to protrude from the retraction device 101 or retraction device holder 102 at its front end, as shown in FIG. 46A. Such a shape of the tip can facilitate pushing the retraction unit 100 forward through the patient's tissue. In this way, the tip can also function as a path finder.

[0407] First arm 135 and second arm 137 of retraction device 101 optionally fit closely to an outer surface of retraction device holder 102, as shown in FIG. 46A.

[0408] The arrows in Fig. 46B indicate the step after positioning the distal end portion of the retraction device 101 near the hole 302. When correctly positioned, the distal ends 112 of the two arms 135, 137 should be positioned inside the hole 302 such that when retracting the deployment device 103, the arms 135, 137 retract or enlarge the hole 302 as indicated in Fig. 46B, the result of which step is shown in Fig. 46C. As mentioned above, the step of retracting the deployment device holder 103 is indicated by the arrow parallel to it.

[0409] After the deployment device 103 is fully pulled out of the retraction device 101, and possibly even out of the lumen of the retraction device holder 101, resulting in separate elements 102, 103 as shown in Fig. 46C, the cross section of the retraction device holder 102 may change from its first shape, e.g., circular, to a second shape, e.g., elliptical. This change in cross section back to the second shape may be triggered, performed, or brought about by the particular material, configuration, etc. of the retraction device holder 102. For example, it may be made of a fabric, have shape memory, a shape memory alloy, etc.

[0410] The change in shape may result from elastic deformation of the retraction device holder 102 or portions thereof that occurs when the deployment device 103 is retracted from the lumen of the retraction device holder 102 .

[0411] The process of changing the cross-sectional shape from a first shape (e.g., circular) to a second shape (e.g., elliptical) can optionally begin immediately after or while the deployment device 103 is being retracted from the retraction device holder 102.

[0412] Preferably, the length D of the elliptical shape N corresponds to nearly the complete retraction and / or expansion distance of the hole 302 in order to clamp and close the hole 302 in a later step. To this end, the cross-sectional shape of the closure device holder 802 is preferably similar to the second, e.g. elliptical, shape that the retraction device holder 102 assumes when it is separated from the retraction device holder 102, i.e., in the state shown in Fig. 46C. This subsequent step is explained in detail in Fig. 47 below.

[0413] 46D shows an optional design of the distal end portion of the retraction device holder 102. Two grooves 139 are provided in the distal end portion, opening at the distal end and parallel to the longitudinal axis L, to accommodate the first arm 135 and the second arm 137 of the retraction device 101. The grooves 139 are arranged opposite each other, which means that they have an angle of 180 degrees with respect to the circumference of the retraction device holder 102. These grooves 139 can advantageously incorporate the two arms 135, 137 for easily pushing the retraction unit 100, including the retraction device holder 102 and the retraction device 101, forward through the tissue to the hole 302.

[0414] 46E shows a portion of a further exemplary embodiment of the retraction device 101. The arms 135, 137 are truncated compared to the embodiment shown in FIG. 47B. The arms 135, 137 are an integral part of the distal end portion of the retraction device holder 102.

[0415] In some embodiments, there are no arms at all. The distal end portion of the retraction device holder 102 can include a shape having, for example, two notches and two tooth-like peaks. The peaks can act as a retractor when the cross-sectional shape of the retraction device holder 102 is elastically or otherwise conformed to the elliptical cross-sectional shape of the closure device holder 802.

[0416] FIG. 47 is a schematic perspective view of an additional exemplary embodiment of the closure device holder 802 and retraction device 101.

[0417] Fig. 47A shows an additional exemplary embodiment of the closure device holder 802. The optional elliptical cross-sectional shape of the closure device holder 802 is designed to fit the elliptical cross-sectional shape of the retraction device 101 shown in Fig. 46C and / or Fig. 47C. This means that this exemplary embodiment of the closure device holder 802 can be inserted and / or pushed into the inner retraction device 101 only after pulling the retraction device holder 102 out of the retraction device 101 as shown in Fig. 46C. This feature is advantageous for the user of the medical device, since the first step involving sliding up to the hole 302 of the retraction unit 100 shown in Fig. 46A is not possible with the closure device holder 802 instead of the retraction device holder 102. For safety reasons, mix-ups are excluded.

[0418] 47A is an exemplary embodiment having three parallel guides for the closure device 600. The design of the closure device 600 with two arms that bend laterally at the exit of the distal end of the closure device holder 802 is optional and other designs are possible.

[0419] 47B shows another exemplary embodiment of the closure device holder 802. The design of the distal end of the closure device holder 802 can be individually configured according to the needs in each case of appropriate application of the closure device 600 (described above) to the hole 302.

[0420] The exemplary embodiment of the closure device holder 802 shown in FIG. 47B includes several bars 809 with grooves 810 arranged between them. At the base of the grooves 810, an opening for releasing the closure device 600 is located. As shown in FIG. 47C (the elliptical shape of the cross section is not as narrow as the shape shown in FIG. 47A in its minimum diameter), during the closure of the hole 302 of the blood vessel 301 with the aid of the closure device 600, the bars 809 function as spacers to avoid contact between the opening for releasing the closure device 600 and the wall of the blood vessel opposite the hole 302. Thus, due to the bars 809, the closure device 600 is less likely to damage the blood vessel opposite the hole 302. The length 810 of the bars 809 may be selected in relation to the type or size of the blood vessel 301 to be treated using the medical device.

[0421] FIG. 47C illustrates a medical apparatus comprising a closure device holder 802 as shown in FIG. 47A and an additional exemplary embodiment of the retraction device 101 as shown in FIG. 46C to close a hole 302 in a blood vessel 301.

[0422] 48A, 48B show a connector 500 having openings 501, 502 to be penetrated successively, first by a deployment device 103 and then by a closure device holder 802. FIG.

[0423] Connector 500 is preferably or includes a hemostatic valve to prevent blood leakage after the medical device or part of the medical device is introduced into the patient's body.

[0424] The connector 500 is preferably disposed at the proximal end of the retraction device holder 102 .

[0425] The connector 500 is preferably designed integrally with the retraction device holder 102 and / or is preferably non-releasably attached to the retraction device holder 102 .

[0426] One or more materials of the connector 500 and the retraction device holder 102 or portions thereof may be the same or different from one another. Illustratively, the materials may be or include plastic.

[0427] The connector 500 is preferably an introducer sheath, for example, for introducing the deployment device 103 and / or the closure device holder 802 into the retraction device holder 102 .

[0428] The connector 500 may comprise, preferably at its proximal end, one or more openings, sealing lips 501, 502 and / or similar members. The openings and / or sealing lips 501, 502 may preferably be designed as passive valves to avoid blood fluid leakage.

[0429] The opening and / or sealing lip 501, 502 are preferably designed to be penetrated by the deployment device 103 and / or the closure device holder 802. The sealing function may preferably be maintained even after the deployment device 103 and / or the closure device holder 802 are retracted from the opening. In other words, the opening or sealing lip 501, 502 preferably provides a sealing function in a state where neither the deployment device 103 nor the closure device holder 802 has penetrated the sealing lip 501, 502 or advanced through the opening, and after the deployment device 103 or the closure device holder 802 has been introduced.

[0430] Preferably, the sealing lips 501, 502 (or at least a portion thereof) fit tightly with a portion of the outer surface of the deployment device 103 and / or the closure device holder 802 once they are introduced into the lumen of the retraction device holder 102, sealing the proximal end of the retraction device holder 102 against blood leakage.

[0431] The opening (or part thereof) of the connector 500 or its open area may have a first shape, for example a circular shape, for receiving the deployment device 103, preferably of a circular shape. The sealing lip 501 may be designed to form a seal with the outer surface of the device having the first, in particular a circularly shaped cross section. The opening and / or the sealing lip 501 may be designed as or from slits. Preferably, at least 4-6 slits, which may be star-shaped, are part of the circular shape. The angle between the slits is preferably 45 degrees, 60 degrees or 90 degrees.

[0432] At the same time, the opening (or part thereof) of the connector 500 or its open area can have a second shape, for example an elliptical shape, for receiving the closure device holder 802, which is preferably elliptical shaped. The elliptical shaped opening may be covered or closed by a sealing lip 502 designed to form a seal with the outer surface of the elliptical device. The opening and / or the sealing lip 502 can be designed as a slit. At least one slit, which can preferably be oriented with respect to the length of the elliptical shape, is part of a circular shape.

[0433] Thus, the connector 500 may allow both devices having circular and elliptical cross sections to be introduced into the connector 500 and / or into the retraction device holder 102. Also, the lips 501, 502 or membrane may provide a seal with the exterior surface of the device regardless of whether the device has a circular or elliptical cross section.

[0434] The connector 500 preferably includes a port for connecting a flush line 503. The flush line 503 may be an integral part of the connector 500. The flush line 503 may be used to degas the connector 500 and / or to administer drugs and / or fluids to the patient. The flush line 503 may also be designated as a sheath flush line 503.

[0435] 49 shows a perspective view of a portion of a medical device according to the present invention in another embodiment, the portion of the medical device being introduced into the lumen 1006 of the blood vessel 301 through the hole 302.

[0436] A plurality of arms 101a, 101b (four in this exemplary embodiment, although in other embodiments a greater or lesser number of arms may be provided) are provided to function as or as part of the retraction unit 100. As the arms 101a, 101b are advanced into the hole 302, they cause the hole 302 to retract and slit, as indicated in Figure 49. In Figure 49, the arms 101a, 101b are shown in their advanced position where they extend from the casing 117 of the retraction unit 100.

[0437] In this embodiment, some or all of the arms 101a, 101b are aligned, or in a common plane, or in contact with a common plane, or intersect with a common plane, in this way they can allow the hole 302 to expand into a slit shape, while the arms 101a, 101b themselves can still be easily pulled out of the slit because the retraction unit 100 is still in a very flat or knife shape.

[0438] In some particular embodiments, the arms 101a, 101b have different lengths. Thus, the arms may be provided with two or more different lengths. As can be seen in FIG. 49, the outer arms 101a are shorter than the inner arms 101b that are arranged between the outer arms (or they extend or protrude from the retraction unit 100 or its common sheath or casing 117 at a longer length than the outer arms), giving the group or collection of arms a tapered or triangular shape in plan view. It should be noted that in alternative embodiments, the longest or most advanced arm of the arms 101a, 101b may not be one of the inner arms 100b, but for example any other one, for example one of the outer arms.

[0439] Thus, in some embodiments, the retraction unit 100 may comprise or consist of multiple arms, some of which may be of different lengths or may differ in the extent to which they can be advanced from inside the retraction unit 100 to its outside.

[0440] Also, in certain embodiments, all or some of the arms 101a, 101b of the retraction unit 100 may be configured to be advanced to an advanced position and retracted again from an advanced position without bending. For example, the arms may be straight or longitudinal components that either cannot be bent during use or that always run parallel to each other (or both). Thus, in some embodiments, there are no configurations that the arms may take (e.g., due to shape memory features) other than the configuration that the arms have while not advanced.

[0441] Fig. 49 also features several optional protectors 101d, each connected to an arm 101a or 101b, where one protector 101d or multiple protectors 101d may be connected to a particular single arm 101a or 101b. For example, one arm 101a, 101b may be connected to one protector 101d on its top side and to the other protector 101d on its bottom side, as in the example of Fig. 49 (see Fig. 49A for reference).

[0442] Part or all of the protectors 101d may include or consist of a material with shape memory properties. In this way, or by utilizing any other suitable mechanism, they can assume a shape when the respective protector 101d or an arm connected thereto is advanced and moved, for example, out of the casing 117 of the retraction unit 100, which shape is different from the shape that the protector 101d assumes while it is resting inside the casing 117. The optional constriction 141, clamp or bottleneck can help to change or force the protector 101d between what is referred to herein as an deployed position or shape (shown in Figures 49 and 49A) and a folded position or shape that the protector 101d assumes while resting and contained within the casing 117 (position or shape not shown in Figure 49).

[0443] The protector 101d may be arranged to open in a direction that is preferably perpendicular (or perpendicular) to the longitudinal axis of the retraction unit 100 or each arm 101a, 101b.

[0444] The protector 101d may be arranged to open in a direction (or perpendicular) that is preferably perpendicular to the direction of maximum extension of the retracting unit 100 or each arm 101a, 101b in the lateral width B of the retracting unit 100 or its casing 117.

[0445] As can be seen in FIG. 49, the lateral width B (from left to right in FIG. 49) of casing 117 is greater than its width W (see FIG. 49A), giving the casing a flattened, rectangular, oval, etc., cross-section rather than a circular one.

[0446] Figure 49A shows the medical device of Figure 49 from a side view during closure of hole 302 with three closure devices 600 shown in Figure 49. From Figure 49A, the extent of width W of casing 117 can be derived.

[0447] In FIG. 49A, the retraction unit 100 is shown partially introduced into the hole 302 by an exemplary angle of 45°.

[0448] The design of Figure 49, which demonstrates multiple features all independent of one another, can allow for effective closure of large holes in both veins and arteries. Hemostasis can be achieved without leakage using only three or slightly more closure devices 600.

[0449] The closure device 600 shown in Figures 49 and 49A may be that shown in Figures 50 and 50A, or it may be any other closure device or any stapler known or described herein.

[0450] 50 shows a perspective view (from the right side) of a closure device 600 in yet another embodiment, which comprises two arms 604a and 604b, each carrying an optionally pointed end 603. The closure device 600 is shown in a curled position, which is the position that the closure device 600 assumes while holding the edges of the slit together (i.e. after being released from the medical device).

[0451] Arms 604a and 604b may either be derived from a common curled or curved material, or may be attached to one another at an attachment region 609 where they may be glued, welded, or otherwise attached to one another.

[0452] As can be seen from FIG. 50 (see also FIG. 50A), the shape of the closure device 600 is not symmetrical.

[0453] In the particular example of FIG. 50, the asymmetry of the closure device 600 is achieved by tilting the optional mounting region 609 to the right. This asymmetry may be useful when releasing the closure device 600 from a medical device, for example, using an optional pusher, such as the pusher tube 808 as disclosed herein. The asymmetry and tilt of the mounting region 609 may help transfer the force applied by the pusher when using the medical device, as shown in FIG. 49A (see angle there). The tilt may also be useful when inserting the medical device or retraction unit 100 into tissue or hole 302. The medical device may be inserted, for example, at a 45° angle to the tissue surface (which is advantageous for the surgeon). However, the tips of the arms 604a and 604b may enter the wall tissue and still be perpendicular to the vessel wall.

[0454] Therefore, the mounting area 609 may be inclined at an angle of 20° to 60°, preferably 30° to 50° with respect to a line perpendicular to the line of maximum width (left-right direction in FIG. 50).

[0455] As an optional feature, the mounting area 609 may include a through opening 611. The through opening 611 may have a closed periphery or may open towards the circumference with an extension 611a as in FIG. 50. The extension may be narrower than the radius of the through opening 611 itself. Thus, the extension may change the overall shape of the through opening 611 to a keyhole shape. The extension may bottleneck in one plane to the main area of ​​the through opening 611.

[0456] The wires of arms 604a and 604b are preferably made from or comprise flat wires. Flat wires, in contrast to round wires, do not have a circular cross section. The cross section is oval, rectangular, or otherwise deviates from a circular design. Flat wires allow for higher gripping forces without exceeding the irreversible strain threshold of, for example, Nitinol. It is also believed that the closure device 600 is capable of holding the vessel walls with an associated amount of perivascular tissue, clamping them together to create hemostasis and complete closure.

[0457] FIG. 50A shows the closure device 600 of FIG. 50 in another perspective view (from the left side).

[0458] 51 illustrates the closure device 600 in a first state. The closure device 600 is according to one embodiment of the present invention. It may be included in a medical apparatus according to the present invention and may be used according to a method of the present invention.

[0459] The closure device 600 comprises or consists of two arms 604a, 604b.

[0460] The closure device 600 is designed such that the tips 603 or distal ends of the arms 604a, 604b, in one state in which the closure device 600 is not yet fully deployed (as in FIG. 51), end in a plane that is inclined in the longitudinal direction of the proximal and even adjacent ends of the arms 604a, 604b, as shown in FIG. 51. The angle of inclination may be between 20° and 60°, and is preferably about 45°.

[0461] FIG. 51A shows the closure device of FIG. 51 in a second state that the closure device 600 may ultimately assume to close the hole 302. FIG.

[0462] As seen in FIG. 51A, an attachment region 609 is provided where the proximal ends or other portions of the arms 604a, 604b are attached to one another.

[0463] FIG. 51B illustrates the arms of the closure device of FIG. 51 separated from each other.

[0464] As can be seen from FIG. 51B, the asymmetry of the closure device 600 is a result of using two arms 604a, 604b of different shapes when manufacturing the closure device 600.

[0465] The closure device 600 of Figures 51-51B can have any of the features of any other closure device disclosed herein, particularly the features disclosed with respect to Figures 50 and 50A.

[0466] While the description has been given of preferred embodiments, it will be understood by those skilled in the art that the disclosure and description is in many respects merely illustrative and not restrictive, and 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 is to be understood, however, that the invention is not limited to the particular forms or methods disclosed, but on the contrary, the invention encompasses all modifications, equivalents and alternative forms.

[0467] Therefore, the scope of the invention is defined in the claims.

[0468] (Additional Note) The present invention includes the following inventions. (1) 1. A medical device for closing a hole (302) in tissue (301) of a patient, an incision, a puncture, a passageway through tissue, and / or communication with a blood vessel or other body lumen (or hole, for short), comprising: a closure device holder (802) for releasably receiving one or more closure devices (600); a retraction unit (100) for contacting opposing sides of the hole (302) and retracting said sides and / or widening the hole (302) to make the shape of the hole (302) a slit or a slit-like or more slit-like variation of the hole (302) or to enlarge or increase the size or diameter of the hole (302) in at least one or exactly one dimension of the hole (302); A medical device comprising: (2) The retraction unit (100) is At least one retraction device holder (102); At least one retraction device (101), preferably at least partially housed within said retraction device holder (102); Equipped with The retraction device (101) is preferably at least partially releasably accommodated within the retraction device holder (102); The medical apparatus according to (1), wherein the retraction device (101) is preferably arranged in a movable or slidable manner relative to the retraction device holder (102). (3) The retraction unit (100) includes at least a first side and an opposite second side; A first arm and a second arm, A first retraction device (101) and a second retraction device (101), A first retraction device holder (102) and a second retraction device holder (102); A first engagement device (410) and a second engagement device (410), one / said retraction device (101) having at least one of moving the first side away or away from the second side; moving the first arm away or away from the second arm; moving the first retraction device (101) away from or away from the second retraction device (101); moving the first retraction device holder (102) away from or away from the second retraction device holder (102); and / or for moving the first engagement device (410) away or away from the second engagement device (410); The mechanism, The medical device according to (1) or (2), comprising: (4) The closure device holder (802) comprises: remain at least partially parallel to one another throughout the closure of the blood vessel hole (302); or to move away from or away from each other as they are advanced toward the vascular opening (302) and / or out of the occlusion member (800), The medical device according to any one of (1) to (3), (5) The medical device of any one of (1) to (4), further comprising a delivery support (806) for ensuring or assisting the closure device holder (802) to move away from or away from each other when advanced toward the vascular hole (302) and / or out of the closure member (800). (6) The medical device of any one of (1)1 to (5), wherein a bumper or spacer is disposed on the exterior or side of the closure member (800), the closure device holder (802) or the delivery support (806). (7) A handle member (900), The medical device of any one of (1) to (6), wherein the handle member (900) comprises a sleeve (914) having a guide slot (916) or another preferably rotatable or cylindrical element. (8) The medical device of (7), wherein the handle member (900), knob (912), or the sleeve (914) itself comprises a resilient element, spring, or the like, arranged to guide a pin through a pivot point of the guide slot (916). (9) The medical device of any one of (1) to (8), wherein the retraction device (101) comprises a plurality of arms (101a, 101b), at least one of the arms having two legs (121, 123) surrounding or circumscribing at least one opening or intermediate opening (127) between the arms. (10) A medical device as described in any one of (1) to (9), wherein at least one opening (131, 133) in the retraction unit through which the arms (101a, 101b) exit when the medical device is in use has a width that is smaller than its length. (11) The medical device according to any one of (1) to (10), wherein at least one of the openings (131, 133) of the retraction unit through which at least one of the arms (101a, 101b) of the retraction device (101) exits has an elliptical opening area or an elliptical cross-section. (12) The medical device according to any one of (1) to (11), comprising a closure device (600) included in the closure device holder (802). (13) The medical device of any one of (1) to (12), wherein the closure device (600) has two arms (604), and at least one of the arms (604) has at least one or one first bending direction and at least one or one second bending direction. (14) The medical device of (13), wherein in a closed state of the closure device (600) or the vascular hole (302), an end or tip of a first arm of the arms (604) faces away from a second arm of the arms (604), while an end or tip of the second arm (604) faces away from the first arm (604). (15) 15. The medical apparatus of any one of claims 1 to 14, comprising a deployment device (103) configured to be at least partially releasably accommodated within a lumen of the retraction device holder (102). (16) The medical device according to any one of (1) to (15), wherein the retraction device (101) is arranged at a distal tip, end or portion of the retraction device holder (102), and the retraction device (101) and the retraction device holder (102) are preferably designed integrally with each other and / or are preferably non-releasably connected to each other. (17) The medical device of (16), wherein the retraction device (101) comprises or consists of a first arm (135) and a second arm (137), the first arm (135) and the second arm (137) preferably being arranged or provided parallel to each other, at least during or before placing the retraction unit (100) in the hole (302). (18) The medical device of (17), wherein the first arm (135) and the second arm (137) are positioned on a surface of the deployment device (103) and / or are positioned to contact the surface while advancing the retraction device (101) into the hole (302), and the first arm (135) and the second arm (137) are extended to a retracted state for retracting the hole (302) after pulling the deployment device (103) out of the retraction device holder (102), preferably in a passive manner and / or without the use of a motor, manual assistance, and / or mechanism. (19) The retraction device holder (102) or its lumen has a first shape or a first cross-section, preferably a cross-sectional diameter (D R ) and a second shape or cross-section, preferably the cross-sectional diameter (D R ) greater than the length of the main axis (D N 19. The medical device according to any one of (15) to (18), which exhibits, takes or exhibits an elliptical cross-section having a major axis and a minor axis, preferably an oval cross-section having two axes of symmetry, i.e. a major axis and a minor axis. (20) The closure device holder (802) or its cross-sectional shape predominantly takes on the second shape or features, corresponds to, and / or has an elliptical cross-section, preferably with a major axis length (D N ) is slightly smaller than this length. (21) The medical device according to any one of (15) to (20), wherein the closure device holder (802) is preferably at least partially releasably housed within the retraction device holder (102), preferably movable in translation in the longitudinal direction of the closure device holder (802). (22) The medical device of any one of (1) to (21), wherein one or more bars (809) are provided between, adjacent to, or near the openings of the closure device holder (802) for ejecting the closure device (600) and protruding across the opening area of ​​at least one of the openings. (23) The medical device of any one of claims 1 to 22, comprising a connector (500) connected to or integral part of the retraction device holder (102) that provides an opening for advancing the deployment device (103) and / or the closure device holder (802) into the lumen of the retraction device holder (102). (24) The medical device of (23), wherein at least one of the lumen of the connector (500), or a cross-section thereof, or the opening area of ​​the opening, includes both a portion that (at least in part) defines a circular shape and a portion that (at least in part) defines an elliptical shape. (25) 1. A method for closing a hole in tissue (302), comprising: providing the medical apparatus according to any one of claims 1 to 24, comprising the retraction device holder (102), the retraction device (101) having the first arm (135) and the second arm (137), and the deployment device (103), wherein the retraction device (101) is disposed at a distal tip, end or end portion of the retraction device holder (102) or attached to the retraction device holder (102); Inserting the deployment device (103) into the lumen of the retraction device holder (102); pushing both the deployment device (103) and the retraction device holder (102) including the retraction device (101) forward into the hole (302) until at least a portion of the first arm (135) and the second arm (137) are disposed inside the hole (302); withdrawing the deployment device (103) from the lumen of the retraction device holder (102); inserting the closure device holder (802) with the closure device (600) into the lumen of the retraction device holder (102), preferably of a nearly oval or elliptical shape, such that one or more distal openings of the closure device holder (802) for ejecting the closure device (600) from the closure device holder (802) are positioned in the hole (302); pushing, releasing or withdrawing the closure device (600) to close the hole (302); The method includes: (26) 1. A method for closing a hole in tissue (302), comprising: Providing a medical device according to any one of (1) to (24); closing the hole (302) with the medical device; The method includes: (27) A closure device (600) for closing a hole (302), incision, puncture, passage through tissue, and / or communication with a blood vessel or other body cavity (or hole for short) in a patient's tissue (301), the closure device (600) having two, at least two or more arms (604, 604a, 600b) for penetrating the tissue (301). [Explanation of symbols]

[0469] 100 Retraction unit 101 Retraction device 101a Arm 101b Arm 101d Protector 102 Retraction device holder 103 Deployment Device 108 Arrow 110 Distal tip, end, distal end of retraction device holder 111 Proximal end 112 Distal end 115 Guidewire lumen 117 Casing 121 Legs 123 Legs 125 Welded parts 127 Middle opening 131 Opening 133 Opening 135 First Arm 137 Second Arm 139 Groove 141 Stenosis 202 Sutures, Retention Devices 203 Piston 204 Groove 207 Groove 301 Blood vessels, blood vessel walls, tissues 302 (of blood vessels) hole, slit opening, hole opening 303 Outside the patient's body 304 Skin of the patient's body 305 Inside the Patient's Body 410 Engagement Device 420 Curved section, step 500 Connector, Hemostasis Valve 501 Opening, sealing lip, slit 502 Openings, sealing lips, slits 503 Water washing line, sheath water washing line 600 Closure Device 602 Proximal end, joint, groove 603 Distal end, pointed end, closure member, tip of closure device, end of closure device 604 Arm 604a Arm 604b Arm 605 Curled or curved parts 607 Non-curved or straight sections 609 Mounting Area 611 Through opening 611a Extension 708 Anchor, Anchor form of closure device 709 State in which the tip 603 penetrates the tissue wall 722 603 Perforation 800 Closure member 801 Longitudinal arrow, arrow indicating orientation of support / closure device holder 802 Closure Device Holder 803 Channel, Horizontal Channel 804 Distal end, closure device holder end 805 Proximal end, closure device holder end 806 Delivery Support 807 Bumper 808 Pusher tube 809 (Occlusion Device Holder) Bar 810 Groove (between bars) 900 Handle material 902 First Slider 904 Second Slider 906 Switch 908 Opening of handle member 910 Multi-lumen extrusions or openings 912 Nobu 914 Sleeve 916 Guide Slot 916a First slot portion 916b Second slot section 916c Turning Point 1000 Guidewire 1006 Blood vessel lumen 1411 Walls and edges of holes 1420 Arrow 1421 Upward Movement 1422 angle 1722 Protractor 2204 Wall, Hole Wall, Long Side 2600 Suture 2700 Arrow B. Width L Longitudinal axis D R Cross-sectional diameter D N Spindle length W width

Claims

1. 1. A medical device for closing a hole (302) in tissue (301) of a patient, an incision, a puncture, a passageway through tissue, and / or communication with a blood vessel or other body lumen (or hole for short), comprising: a closure device holder (802) for releasably receiving one or more closure devices (600); a retraction unit (100) for contacting opposing sides of the hole (302) and retracting said sides and / or widening the hole (302) to make the shape of the hole (302) a slit or a slit-like or more slit-like variation of the hole (302) or to enlarge or increase the size or diameter of the hole (302) in at least one or exactly one dimension of the hole (302); Equipped with The retraction unit (100) comprises: at least, A first retraction device (101) and a second retraction device (101), A first retraction device holder (102) and a second retraction device holder (102) and a first side and an opposite second side; A first arm and a second arm, and A first engagement device (410) and a second engagement device (410) A retraction device (101) having at least one of moving the first side away or away from the second side; moving the first arm away or away from the second arm; moving the first retraction device (101) away or away from the second retraction device (101); moving the first retraction device holder (102) away from or away from the second retraction device holder (102); and / or a mechanism for moving the first engagement device (410) away from or away from the second engagement device (410); The retraction device (101) is at least partially releasably housed within the retraction device holder (102); The retraction device (101) is arranged in a movable or slidable manner relative to the retraction device holder (102). Medical equipment.

2. The closure device holder (802) comprises: remain at least partially parallel to one another throughout the closure of the blood vessel hole (302); or to move away from or away from one another as they are advanced toward the opening (302) in the blood vessel and / or as they are advanced out of the closure member (800), The medical device of claim 1 .

3. The medical device of claim 1 or 2, further comprising a delivery support (806) for ensuring or assisting the closure device holders (802) to move away from or away from each other as they are advanced toward the vascular hole (302) and / or out of the closure member (800).

4. The medical device of claim 1 , further comprising a bumper or spacer disposed on an exterior or side of the closure device holder (802) or the delivery support (806).

5. A handle member (900), 5. The medical device of claim 1, wherein the handle member (900) comprises a sleeve (914) or another preferably rotatable or cylindrical element having a guide slot (916) for guiding a pin of the knob (912).

6. 6. The medical device of claim 5, wherein the handle member (900), the knob (912), or the sleeve (914) itself comprises a resilient element or spring arranged to guide the pin through a pivot point of the guide slot (916).

7. 2. The medical apparatus of claim 1, wherein the retraction device (101) comprises a plurality of arms (101a, 101b), at least one of the arms comprising two legs (121, 123) surrounding or circumscribing at least one opening or intermediate opening (127) between the arms.

8. 8. The medical device of claim 7, wherein at least one opening (131, 133) in the retraction unit (100) through which the arms (101a, 101b) exit when the medical device is in use has a width that is smaller than its length.

9. 9. The medical device of claim 8, wherein at least one of the openings (131, 133) of the retraction unit (100) through which at least one of the arms (101a, 101b) of the retraction device (101) exits has an elliptical opening area or an elliptical cross-section.

10. The medical apparatus of claim 1 , further comprising a closure device (600) included in the closure device holder (802).

11. The medical device of any one of claims 1 to 10, wherein the closure device (600) has two arms (604), at least one of the arms (604) having at least one or one first bending direction and at least one or one second bending direction.

12. 12. The medical device of claim 11, wherein in a closed state of the closure device (600) or the vascular hole (302), an end or tip of a first arm of the arms (604) faces away from a second arm of the arms (604), while an end or tip of the second arm (604) faces away from the first arm (604).

13. The medical apparatus of claim 1 , comprising a deployment device (103) configured to be at least partially releasably received within a lumen of the retraction device holder (102).

14. 2. The medical device of claim 1, wherein the retraction device (101) is arranged at a distal tip, end or portion of the retraction device holder (102), and the retraction device (101) and the retraction device holder (102) are preferably designed integrally with each other and / or are preferably non-releasably connected to each other.

15. 15. The medical device of claim 14, wherein the retraction device (101) comprises or consists of a first arm (135) and a second arm (137), the first arm (135) and the second arm (137) being preferably arranged or provided parallel to each other, at least during or before placing the retraction unit (100) in the hole (302).

16. 14. The medical device of claim 13, wherein a first arm (135) and a second arm (137) are disposed on a surface of the deployment device (103) and / or are disposed to contact the surface while advancing the retraction device (101) into the hole (302), and the first arm (135) and the second arm (137) are extended to a retracted state for retracting the hole (302) after pulling the deployment device (103) out of the retraction device holder (102), preferably in a passive manner and / or without the use of a motor, manual assistance and / or mechanism.

17. The retraction device holder (102) or its lumen has a first shape or a first cross-section, preferably a cross-sectional diameter (D Ｒ ) and a second shape or cross-section, preferably the cross-sectional diameter (D Ｒ ) Ｎ 17. The medical device according to claim 13 or 16, which presents, takes or exhibits an elliptical cross-section having a major axis and a minor axis, preferably an oval cross-section having two axes of symmetry, i.e. a major axis and a minor axis.

18. The closure device holder (802) or its cross-sectional shape predominantly takes on the second shape or features, corresponds to, and / or has an elliptical cross-section, preferably with a major axis length (D Ｎ 20. The medical device of claim 17, wherein the length of the distal end of the proximal end of the distal end of the first proximal end of the second proximal ...

19. The medical apparatus of any one of claims 13 to 18, wherein the closure device holder (802) is at least partially releasably housed within the retraction device holder (102) which is translationally movable in the longitudinal direction of the closure device holder (802).

20. A medical device as described in any one of claims 1 to 19, wherein one or more bars (809) are provided between, adjacent to, or near the openings of the closure device holder (802) for ejecting the closure device (600) and protruding across the opening area of ​​at least one of the openings.

21. 14. The medical device of claim 13, comprising a connector (500) connected to or integral part of the retraction device holder (102) that provides an opening for advancing the deployment device (103) and / or the closure device holder (802) into the lumen of the retraction device holder (102).

22. 22. The medical device of claim 21, wherein at least one of the lumen of the connector (500), or a cross-section thereof, or the opening area of ​​the opening, includes both a portion that at least partially defines a circular shape and a portion that at least partially defines an elliptical shape.

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