Medical devices and methods for closing tissue holes

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 of the hole (302), or for expanding 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, a method for closing a hole according to the preamble of claim 19, a method according to claim 21, a closure device according to claim 22 and a set according to claim 23.

[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 blood vessel walls, particularly following invasive procedures within a patient's body. Summary of the Invention [Problem to be solved by the invention]

[0003] An object of the present invention may be to propose further medical apparatus, methods, closure devices and sets for closing holes. [Means for solving the problem]

[0004] The above-mentioned object is achieved by a medical device for closing a hole, e.g. having the features of claim 1. It is further achieved by a method for closing a hole, e.g. having the features of claim 19, a method according to claim 21, a closing device having the features of claim 22, and a set according to claim 23.

[0005] 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 is intended to exemplify embodiments according to the present invention.

[0006] Whenever numerical terms are referred to herein, those skilled in the art will recognize or understand them as designating a lower limit of the numerical value. Thus, unless this results in a clear contradiction to those skilled in the art, those skilled in the art will understand, for example, "one" to encompass "at least one." This understanding is also equally encompassed by the present invention as the interpretation that a numerical term, for example, "one," can alternatively mean "exactly one," whenever this is clearly technically possible from the perspective of those skilled in the art. Both of these understandings are encompassed by the present invention and apply to all numerical terms used herein.

[0007] Where the subject matter of the invention is disclosed herein as comprising one or several features in certain embodiments, it is also hereby disclosed that the subject matter of the invention does not explicitly comprise this or these features in other embodiments that are also inventive, 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.

[0008] The present invention therefore proposes a medical device for closing a hole, incision, puncture, passageway through tissue, and / or communication with a blood vessel or other body cavity (hole for short) in a patient's tissue, wherein the medical device comprises a closure device holder for releasably receiving and / or holding one or more closure devices.

[0009] The medical device optionally further comprises a retraction unit. The retraction unit may be designed or arranged to, during use of the medical device, preferably contact the tissue-opposing side of the hole to retract tissue and / or widen the hole, optionally causing the hole to become a slit or a slit-like or more slit-like hole in shape. 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 parts of the retraction unit (e.g., between the retraction devices or, if provided, between their arms or between the tips of the arms), 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.

[0010] Additionally, methods are proposed, a first method comprising providing and / or configuring a medical device according to the present invention, and a second method relating to closing a hole using the medical device.

[0011] A set according to the invention comprises or consists of a medical device according to the invention and optionally a further guidewire.

[0012] In this case, the medical apparatus comprises a closure device holder, a retraction device holder, and a deployment device, each of which are described herein.

[0013] Advantageous developments of the invention are the subject matter of the dependent claims and embodiments, respectively.

[0014] 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.

[0015] 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.

[0016] 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 preferably be at least partially housed in the retraction device holder. The retraction device may optionally be at least partially housed in the retraction device holder, preferably in a releasable manner, and is preferably arranged in the retraction device holder in a manner that is movable or slidable relative to the retraction device holder.

[0017] 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.

[0018] A mechanism may be provided for moving the retraction device into and out of the retraction device holder.

[0019] In some embodiments, at least two retraction devices of the medical apparatus according to the invention are releasably captured in a retraction device holder, in particular configured such that they can be at least partially released from the retraction device holder by manipulating the retraction device holder or a mechanism configured to do so, if necessary, in order to be positioned below the opening level of the hole to be closed.

[0020] In some embodiments, the retraction device holder and / or retraction device of the medical device of the present invention is specifically configured to retract opposing sides of the hole 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.

[0021] In some embodiments, the retraction unit of the medical device according to 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, and / or First retraction device holder and second retraction device holder The at least one retraction device has at least one of:

[0022] 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 a combination of materials mentioned herein.

[0023] 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.

[0024] In some embodiments, the handle member or its casing comprises at least one rotational element that converts rotation to translation, e.g., for a user, while in other embodiments the handle member or its casing does not include such a rotational element.

[0025] In some embodiments, the mechanism may comprise or consist of a vacuum device configured to modify the shape of a 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.

[0026] The vacuum device may be configured to suck fluid (e.g., air) from an internal, preferably closed, lumen of the retraction unit, e.g., 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 within the lumen. In this way, e.g., first and second opposing sides of the retraction unit move away from each other while the circumference of the retraction unit remains constant.

[0027] The preferably closed lumen in fluid communication with the vacuum device can have a cross-section that is longer in a first direction than in a second direction perpendicular to the first direction in at least one state (whether or not a vacuum is applied).

[0028] In some embodiments, the retraction unit or retraction device has a curve or step, or is bent at its front or rear, 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 curve, 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 for deploying the closure device. To achieve this, the curve, step, etc. can be positioned, for example, less than a predetermined distance from the free end of the medical device or retraction device. The curve, step, or the point at which it bends can also act as a protection against withdrawing the medical device too far from the vessel lumen before releasing the closure device.

[0029] In some embodiments, the medical device does not include and / or is not connected to a vacuum device or source.

[0030] In some embodiments, the medical device is not a pressure stabilizer.

[0031] In some embodiments, the parts of the retraction device deflect or move away from each other when released or in an unstressed state and / or when used to retract tissue.

[0032] In some embodiments, the retraction device and the closure member or parts thereof may each at least partially extend from the same handle member.

[0033] 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 hole to become a slit or slit-like or more slit-like in shape, 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 the arms, if provided, away from each other.

[0034] In some embodiments, a medical apparatus according to the present invention comprises at least one closure device contained within a closure device holder.

[0035] 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.

[0036] In some embodiments, the closure device of a medical device according to 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, by, for example, bending two or more arms out of the closure device holder, thereby positioning the two or more ends to pierce the interior wall of the tissue surrounding the hole.

[0037] In some embodiments, at least a portion of the closure device, retraction device, or retraction device holder 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.

[0038] In some embodiments, at least a portion of the closure device, retraction device, or retraction device holder of the medical device of the present invention is made from Nitinol.

[0039] In some embodiments, at least a portion of the closure device, retraction device, or retraction device holder of the medical apparatus of the present invention is made from a biocompatible and / or bioabsorbable material.

[0040] 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.

[0041] 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.

[0042] In some embodiments of the medical devices of the present invention, the closure device, or a portion thereof, curls into a loop, ring, or circle-like shape when in an unstressed state.

[0043] In some embodiments of the medical apparatus of the present invention, the closure device after deployment has a cross-sectional dimension ranging from 10 micrometers to 1 centimeter, preferably from 40 micrometers to 200 micrometers, and more preferably from 50 micrometers to 100 micrometers.

[0044] In some embodiments, the closure device has two arms.

[0045] 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: unequal to one another, pointing opposite one another, pointing away from one another, etc.

[0046] In some embodiments, in a closed state of the closure device or vascular hole, the end or tip of a first one of the arms faces away from the second one of the arms, while the end or tip of the second arm faces away from the first arm.

[0047] In some embodiments, the medical device comprises or consists of a handle member (or handle or handle device).

[0048] In some embodiments, the handle member can have a first slider and, optionally, a second slider arranged to be moved by a user, preferably longitudinally of the handle member, to actuate or advance the retraction device.

[0049] 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.

[0050] In some embodiments, all or a portion of the closure device holders are completely or only partially parallel to one another.

[0051] In some embodiments, the casing of the handle member comprises 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.

[0052] 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 or deviate from one another as they are advanced toward the vascular opening.

[0053] In some embodiments, the closure device holders are not parallel to each other, or only portions of them (e.g., their proximal portions) are parallel, but for example, their distal portions (e.g., their tips) are not parallel. In certain embodiments, the proximal portions are parallel to each other. In some embodiments, the distal portions are optionally under a predetermined angle with respect to each other.

[0054] 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 hole, for example, when advanced toward the vascular hole for closure.

[0055] 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.

[0056] In certain embodiments, for example, when advanced toward a vascular hole for closure, or in its unstressed or fully deployed state, the distance between the tips or distal ends of the portions of the retraction device or their arms is greater than the distance between the tips or distal ends of the portions of the closure device holder described above.

[0057] In some embodiments, a delivery support is provided to ensure that the closure device holders deflect or move away from each other as they are advanced towards the vascular opening.

[0058] In some embodiments, the delivery support comprises or consists of a wire, a wire netting or structure.

[0059] In some embodiments, the delivery support is a collapsible and / or non-collapsible element.

[0060] In some embodiments, a closure device holder or delivery support bumper is located on the exterior or side of the closure member.

[0061] In some embodiments, the handle member comprises a sleeve or preferably another rotatable or cylindrical element, optionally having a U-shaped or V-shaped guide slot, which may be part of or added to the outer surface of the sleeve.

[0062] In some embodiments, the guide slot includes a first slot portion and a second slot portion, each connected to one another by another slot portion, called a turn point.

[0063] 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 turning point of the guide slot.

[0064] In some embodiments, the retraction device comprises multiple (here two) arms.

[0065] In some embodiments, the arm of the retraction device comprises two legs, referred to as the outer leg and the inner leg.

[0066] In some embodiments, the outer leg and inner leg may be welded together at or by a welded portion.

[0067] In some embodiments, the outer and inner legs surround or circumscribe one or two intermediate openings that may be or form a trough opening therebetween.

[0068] In some embodiments, the inner leg is straight or substantially straight.

[0069] In some embodiments, the outer legs are bent to have or form a depression, bulge, or indentation.

[0070] 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.

[0071] 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.

[0072] In some embodiments, at least one of the openings in the retraction unit and / or closure device holder through which the at least one arm exits has an oval opening area. Other shapes of the openings in the retraction unit and / or closure device holder, such as rectangular shapes, are also encompassed by the present invention.

[0073] In some embodiments, the medical apparatus according to the present invention further comprises a pushing device, preferably extending through the proximal end of the closure device holder, for manipulating the closure device, which may be configured to act on the closure device, e.g., by pushing the closure device, without deforming the closure device.

[0074] In some embodiments of the medical apparatus according to the present invention, the pushing device is or comprises a rod or piston.

[0075] 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.

[0076] In some embodiments, the retention device of the medical device of the present invention is a string or suture.

[0077] 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.

[0078] In some embodiments of the medical device according to the present invention, the distal end of the closure device holder has two or more channels in the wall of the closure device holder. These channels allow one or more ends of the closure device to exit the closure device holder during operation of the medical device or when needed by the user. The ends may exit from one or both sides of the closure device holder. The channels may be slit-shaped. The channels or their proximal ends may be surpassed distally by the distal end of the closure device holder.

[0079] In some embodiments of the medical device according to 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.

[0080] In some embodiments of the medical apparatus according to the present invention, the retraction device holder is or comprises an elongated tube, for example including or made of metal or plastic, and preferably configured to capture the retraction device.

[0081] 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 to providing access for manipulating the closure device when and if contained within the closure device holder.

[0082] 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 the casing or outer sheath of the medical device.

[0083] In some embodiments, the medical device comprises some or all elements of the medical device (excluding, of course, the housing or casing and the like), in particular an outer housing, sheath or casing with a closure device holder and / or retraction unit.

[0084] In some embodiments, the medical device comprises a lumen for guiding and / or surrounding a guidewire, which may be open to both the distal and proximal ends of the medical device, or only to one of them.

[0085] 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.

[0086] Any lumen in the medical device may be a through opening in the medical device, preferably extending longitudinally through the medical device.

[0087] 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 thereof.

[0088] In some embodiments of the method of the present invention, the method comprises: Introducing a portion of the retraction unit into the hole; bringing opposite sides of the hole into contact 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.

[0089] The contacting step and the retracting step may be one and the same step, or they may be performed in a common step, such as advancing the medical device, set or part thereof through the hole into the blood vessel.

[0090] In some embodiments of the method according to the invention, the step of retracting opposite sides of the hole and / or widening the hole results in a hole whose shape has changed, for example to become 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.

[0091] In some embodiments, at least one of the closure device holder and the retraction device holder is a partially hollow tube.

[0092] 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.

[0093] In some embodiments, the closure member is the same or the same component as the closure device holder.

[0094] In some embodiments, the retraction unit is the same or the same component as the retraction device holder.

[0095] In some embodiments, the retraction unit and the closure member are embodied by only one device.

[0096] 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.

[0097] 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.

[0098] 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 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.

[0099] 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, particularly does not have a device configured to plastically deform the closure device during ejection or release, and preferably does not have a device for closing the closure device.

[0100] 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 through a common opening in the holder, and they leave 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. They may also be arranged to release sequentially rather than simultaneously, for example, the middle closure device first, then the outer closure device.

[0101] 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.

[0102] 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.

[0103] 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 enlarging the hole.

[0104] In some embodiments, the retraction unit and the closure device holder are separate from each other and in particular can move separately from each other, while in other embodiments they are interconnected with each other or embodied by the same unit so that they cannot move independently of each other.

[0105] In some embodiments, the retracting unit and the closure device holder are spaced apart from each other so that the closure device holder is configured to eject or release one or more closure devices into the 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 retracting unit.

[0106] In some embodiments, at least one of the components of the retraction unit configured to retract opposite sides of the hole by directly contacting them is an elongated or rectangular section, at least one of which may have a shape such as a pole or a tube, which is preferably straight.

[0107] 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, and / or the first and second retraction device holders) configured to retract by directly contacting opposite sides of the hole does not include one or more hinges, articulations, joints, or portions that bend, particularly in its central portion, and more particularly, portions that do not face in opposite directions to each other.

[0108] In some embodiments, a component of the retraction unit configured to retract opposing sides of the hole by directly contacting these sides has a free distal end.

[0109] 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 include arms or tines that move toward each other when closed or deployed. The movement may also occur substantially in one plane, i.e., in the second plane. The first and second planes may intersect each other. They may be substantially perpendicular to each other.

[0110] 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 one another 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 one another. In fact, they may be perpendicular or substantially perpendicular to one another. 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 a surgeon.

[0111] In some embodiments, the first and second retraction devices, or the first and second arms or portions thereof, are connected to one another 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 a first direction. Thus, in these embodiments, the hinge or joint or portion may optionally not move in a direction that retracts or widens opposing sides of the hole.

[0112] There is also proposed a medical device for closing a hole in tissue, according to the present invention, The medical device comprises: a closure device holder having a distal end for extending through the tissue opening in the 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 the 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 so that it releases its stress by bending two or more arms out of the closure device holder, thereby causing the two or more ends to perforate the inner wall of the tissue surrounding the hole.

[0113] There is also proposed a method for closing a hole in tissue according to the present invention, comprising: This method is Providing a medical device according to the present invention; and closing the hole with a medical device.

[0114] In some embodiments of the present invention, at least a portion of the closure device is made from a deformable shape memory alloy.

[0115] In some embodiments of the present invention, at least a portion of the closure device is made from nitinol.

[0116] In some embodiments of the present invention, at least a portion of the closure device is made from a biocompatible and / or bioabsorbable material.

[0117] In some embodiments of 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.

[0118] In some embodiments of the present invention, the closure device curls into a closed configuration when in an unstressed state.

[0119] In some embodiments of the present invention, the closure device curls into a loop, ring, or circle when in an unstressed state.

[0120] In some embodiments of the present invention, the closure device after deployment of the medical device has a cross-sectional dimension ranging from 10 micrometers to 1 centimeter, preferably from 40 micrometers to 200 micrometers, and more preferably from 50 micrometers to 100 micrometers.

[0121] In some embodiments according to the present invention, the medical apparatus includes a pushing device extending through the proximal end of the closure device holder for manipulating the closure device.

[0122] In some embodiments according to the present invention, the pushing device is a rod or a piston.

[0123] In some embodiments of the present invention, the medical apparatus includes a holding device extending through the proximal end of the closure device holder for manipulating the closure device, said holding device being mounted with the closure device.

[0124] In some embodiments of the present invention, the retention device is a string or suture.

[0125] 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.

[0126] 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, allowing one or more ends of the closure device to exit the closure device holder when the closure device is deployed.

[0127] In some embodiments according to the present invention, the distal end of the closure device holder has two channels located on opposite sides of the wall of the closure device holder.

[0128] Most state-of-the-art systems, such as those utilizing plugs, clips, or sutures, are only capable of closing fairly small arterial perforations, up to 10 French (Fr), and are approved only for arterial entry sites. Some systems are also used off-label to close larger arterial or venous punctures.

[0129] The present invention can advantageously provide a more effective method and medical device for sealing large foramen magnum punctures, up to 30 French (Fr) or larger, of veins and other passageways through tissue.

[0130] The present invention allows for connecting tissue segments to one another or closing and / or sealing openings through tissue such as very large holes, vascular perforations, etc. in the venous system, particularly the femoral vein.

[0131] Such large vascular access and drilling is required for more complex interventional procedures such as transseptal mitral and tricuspid valve repair and prosthetic implantation.

[0132] The femoral vein has a diameter of approximately 8 mm or greater, or approximately 24 French (Fr), allowing for the introduction of systems of similar diameters. Closing such large vein perforations with percutaneous systems utilizing plugs, sutures, or clips is extremely difficult. Closing such large perforations using a circular or longitudinal technique carries a high risk of vascular stenosis.

[0133] According to the present invention, a specific technique is advantageously used to elongate the perforation in a direction perpendicular to the vessel longitudinal axis and to tightly suture the perforation along this elongation, thus avoiding narrowing of the vessel lumen.

[0134] The present invention allows for the closure of large caliber vascular perforations, particularly in veins, by elongating the perforation perpendicular to the vessel's long axis and placing a single clip along the extension that closes the perforation along the line of elongation.

[0135] 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, and a retraction unit and a closure member that are subsequently or simultaneously deployed into the opening in the tissue. 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 them to be at least partially disposed within the opening or lumen of the blood vessel in a controlled manner, particularly along a guide structure such as a guidewire or other rail (not shown) that is commonly disposed within the blood vessel to perform an interventional procedure.

[0136] The retraction unit optionally includes two retraction device holders having distal ends configured to extend through the holes and to be positioned on opposite insides of the hole to be closed, the retraction units configured to move apart and retract opposite sides of the hole, approximating the opposite sides of the hole between the retraction devices, so that the hole becomes linear with one extended major axis and an orthogonal contracted minor axis.

[0137] 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 holders 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.

[0138] The closure device is preferably a sharp needle that penetrates the tissue wall surrounding the hole as the closure device holder is withdrawn, and when the closure device engages the tissue wall, it can be detected as a firm resistance to further withdrawal.

[0139] 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.

[0140] The closure device optionally includes a plurality of circular needles sized, oriented, and shaped 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 to the wall, drawing the tissue surrounding the perforation into proximity of the closed hole and closing the hole, with the drawn-in surrounding tissue further sealing the tissue closure.

[0141] The closure device or devices can optionally be disengaged from the closure device holder and delivery mechanism and left in place.

[0142] 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.

[0143] In some embodiments of the present invention, a medical device comprising one or more retraction units is proposed for use in closing a hole, incision, puncture, or other passageway through tissue, or communication with a blood vessel or other body cavity.

[0144] 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 operation.

[0145] 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 manipulation of the closure device holder and deployment of the closure device closes the hole.

[0146] In some embodiments according to the present invention, the medical device comprises a set of retraction units.

[0147] In some embodiments according to the invention, the medical device includes instructions to the user, embodied for example as a sign, arrow, or the like, indicating the orientation or direction of the retraction unit of the medical device.

[0148] In some embodiments of the present invention, the medical device further includes a delivery device for delivering the closure device holder into operable proximity with the hole, the delivery device being, for example, slidably connected to the closure device holder.

[0149] In some embodiments according to the invention, the retraction device holder comprises an elongated tube made of metal or plastic that can capture the retraction device.

[0150] In some embodiments of the present invention, the retraction units can be moved apart to retract the holes.

[0151] In some embodiments according to the invention, the retraction device holder comprises an elongated tube made of metal plastic or other material that can capture the retraction device.

[0152] 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.

[0153] 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.

[0154] In some embodiments of the present invention, the closure device is made of a perforated material, preferably a needle, selected from the 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.

[0155] In some embodiments, the present invention provides a closure device having a predetermined cross-section, a proximal end, and two arms, each having a pointed end, that are bending portions of the closure device to expand between a first state when compressed and captured in a second state within the closure device holder. The closure device is substantially linear and can be moved along the inner axis of 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 their expanded second state with the arms having a bent shape, forming a ring having two half circles or semicircles.

[0156] In some embodiments of the present invention, the closure device has a pre-set configuration that allows the closure device to be connected to the closure device holder.

[0157] In some embodiments of the present invention, the present invention relates to a method for closing a hole, incision, puncture, or other passageway through tissue, in communication with a blood vessel or other body cavity, particularly but not limited to, a blood vessel having a lumen that carries blood.

[0158] The method comprises: a. causing the hole to change shape from a somewhat rounded hole to a more slit-like hole with a reduced diameter axially relative to the vessel long axis and an expanded orthogonal diameter relative to the vessel long axis diameter in order to retract opposing sides of the hole to connect the expanded orthogonal sides of the hole; b. inserting one or more closure devices into the vessel lumen through the hole and deploying them uniformly or non-uniformly, the closure devices being manipulated to engage the vessel wall surrounding the hole with the extended long side of the hole between the shoulders, connecting the two extended orthogonal sides of the retracted hole sides and closing the hole; Includes.

[0159] In some embodiments according to the invention, the closing step comprises suturing, clamping, or similar mechanical approximation of the walls of the engaged hole.

[0160] In some embodiments, the at least two retraction devices are captured in the retraction device holder in a releasable manner, particularly so that they can be at least partially released from the retraction device holder by manipulating the retraction device holder, particularly so that they are configured to be positioned below the opening level of the hole to be closed.

[0161] In some embodiments, the retraction device holder and / or retraction device is 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 transverse diameter is at least twice the length of the retracted longitudinal diameter of the hole.

[0162] In some embodiments, the feature comprises or consists of a shape memory property.

[0163] 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, for example via two or more arms.

[0164] In some embodiments, the closure device is contained within the closure device holder such that when the closure device is manipulated to emerge from the distal end of the closure device holder during use of the medical apparatus, the closure device releases 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.

[0165] In some embodiments, at least a portion of the closure device, retraction device, or retraction device holder is made of a deformable shape memory alloy and / or has a self-expanding shape memory portion or wire body.

[0166] In some embodiments, the closure device holder, the retraction device, and at least a portion of the retraction device holder are made of Nitinol.

[0167] In some embodiments, at least a portion of the closure device, retraction device, or retraction device holder is made from a biocompatible and / or bioabsorbable material.

[0168] In some embodiments, the closure device, or a portion thereof, curls into a closed configuration when in an unstressed state.

[0169] In some embodiments, the occlusion device, or a portion thereof, curls into a loop, ring, or circle when in an unstressed state.

[0170] 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.

[0171] In some embodiments, the pushing device is a rod or piston.

[0172] In some embodiments, the medical apparatus further comprises a holding device extending through the proximal end of the closure device holder for manipulating the closure device, said holding device being attached to the closure device.

[0173] In some embodiments, the retention device is a string or suture.

[0174] In some embodiments, 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 length of the closure device holder.

[0175] 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 as required by the user.

[0176] In some embodiments, the distal end of the closure device holder has at least one channel or two channels disposed opposite each other on the wall of the closure device holder.

[0177] 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.

[0178] In some embodiments, the method comprises: Introducing a portion of the retraction unit into the hole; bringing opposite sides of the hole into contact 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 with the closure device; Further includes:

[0179] In some embodiments, the step of retracting opposite 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 expand or increase in at least one or exactly one dimension of the hole.

[0180] In some embodiments, the retraction device is configured to retract the hole in a direction perpendicular to the longitudinal axis of the retraction unit and / or closure device holder.

[0181] In some embodiments, the retraction device is configured to retract the hole in a direction that is at an angle between 90 degrees and 45 degrees relative to the 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.

[0182] In some embodiments, the retraction device is configured to retract the hole in a direction other than parallel to the longitudinal axis of the retraction unit and / or closure device holder.

[0183] 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.

[0184] In other embodiments, the retraction device or retraction unit comprises a motor and / or a mechanism for acting on the retraction device and / or retraction device holder.

[0185] In certain embodiments, the retraction device and the retraction device holder are configured such that they cannot move independently of each other.

[0186] In some embodiments, the arms are portions, extensions, or protrusions of the retraction device holder. For example, the retraction device holder may have two distal tips, or may be, for example, half-moon shaped, C-shaped, and / or any other shape that allows two portions separated by a gap to diverge from each other and increase the gap or distance between them 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 about "arms" may equally apply to the tips that are the two free ends of the C-shape or half-moon shape described above.

[0187] The term mechanism as used herein refers to mechanisms that include movably arranged parts, such as plungers, gears, motors, and the like, among others.

[0188] In some embodiments, the medical apparatus includes a deployment device configured to be at least partially releasably received within a lumen of a retraction device holder. The deployment device can include a cylindrically shaped body. The cylindrically shaped body can be hollow, partially hollow, or solid. The distal end portion of the deployment device can include a cone-shaped end portion. The very distal end, end, or end portion of the tip can include a spherically shaped tip.

[0189] In some embodiments, the retraction device is located 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 is not releasable or does not require release during use of the invention.

[0190] 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 being arranged or provided parallel to each other, preferably at least during placement of the retraction unit in the hole.

[0191] 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.

[0192] In some embodiments, the retraction device comprises (or consists of) a first arm and a second arm, which are releasably attached to or contact a surface of the deployment device while advancing the retraction device to or into the hole, and which are extended to assume a retracted state in the hole after the deployment device is withdrawn from the retraction device holder.

[0193] 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 out of the retraction device holder.

[0194] In some embodiments, the retraction device holder or its lumen assumes, takes on, or exhibits 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, after the deployment device is partially or fully withdrawn from the retraction device holder.

[0195] 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, 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 withdrawn from the retraction device holder.

[0196] In some embodiments, the closure device holder or its cross-sectional shape is primarily of or corresponds to the second shape or cross-section and / or has an elliptical cross-section, preferably with a major axis length slightly less than this length.

[0197] In some embodiments, the retraction device holder, or a portion thereof, is sufficiently flexible and / or resilient 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 oval 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.

[0198] 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.

[0199] Also, in some embodiments, the retraction device holder or the portion thereof that defines / determines its lumen may be made from a material that does not have a memory effect.

[0200] 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.

[0201] In some embodiments, the medical device includes one or more bars or other protrusions positioned between or adjacent to the openings of the closure device holder for ejecting the closure device. The bars are positioned to protrude across the open area of ​​at least one opening. They may be integral with the closure device holder and can function to prevent damage to the opposing vessel wall or tissue when the closure device is released from the closure device holder.

[0202] In some embodiments, the medical device comprises a connector that is connected to or is an integral part of the retraction device holder, providing an opening for advancing the deployment device and / or closure device holder into the lumen of the retraction device holder.

[0203] 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.

[0204] In some embodiments, the connector may include a seal, membrane, diaphragm, etc. that acts as a seal by conforming or abutting the outer surface of a device inserted through the connector and into the lumen of the retraction device holder.

[0205] 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.

[0206] 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.

[0207] In some embodiments, the closure device holder is preferably at least partially releasably housed within the retraction device holder, preferably in a translational manner in the longitudinal direction of the closure device holder.

[0208] In some embodiments, a method for closing a hole in tissue comprises: providing a medical apparatus comprising a retraction device holder, a retraction device having a first arm and a second arm, and a deployment device, wherein the retraction device is 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 positioned 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 optionally being 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 holes; pushing, withdrawing, or releasing the closure device to close the hole; Optionally, closing the hole utilizing a closure device; Includes.

[0209] In some embodiments, multiple arms are provided that act as or 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.

[0210] In some embodiments, the tips of the retraction units are preferably formed by tips of arms arranged so that they cannot diverge laterally from one another under any circumstances while closing the hole.

[0211] 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 from the retraction unit, common sheath, or casing thereof than others.

[0212] Thus, in some embodiments, the retraction unit may comprise or consist of multiple arms, some of which may be of different lengths or degrees to which they may be advanced from inside the retraction unit to its outside.

[0213] 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.

[0214] In some embodiments, the arms may be straight or longitudinal components that either cannot be bent during use or always extend parallel to one another (or both).

[0215] In some embodiments, there is no other configuration that the arms have (eg, due to shape memory features) than the configuration that the arms have while not advanced.

[0216] The arms may be arranged to be moved from inside to outside the casing or medical device only if moved together, and thus may be interconnected to one another in such a way that they can only be advanced as a group. In other embodiments, they can be advanced individually.

[0217] In some embodiments, a protector is provided, which may include or consist of metal components, such as wires, and / or plastic components, such as plastic bands.

[0218] The protectors may be connected to the arms, which may be configured to be slid together, or just with their respective arms, out of the casing or relative to other parts of the medical device.

[0219] In some embodiments, one arm is connected to one protector on its upper surface and another protector is connected to its lower surface.

[0220] In some embodiments, the protector is arranged to open in a direction that is preferably perpendicular to (or equally perpendicular to) the longitudinal axis of the retraction unit or each arm.

[0221] The protector may be arranged to open in the lateral width of the retraction unit or its casing in a direction that is preferably perpendicular to (or equally perpendicular to) the direction of maximum extension of the retraction unit or each arm.

[0222] In some embodiments, the lateral width of the casing or the width or depth of its retraction unit preferably causes the casing or retraction unit to have a cross section that is flat, rectangular, oval, etc., rather than circular.

[0223] In some embodiments, the closure device comprises or consists of two arms, which may be derived from a common, unitary material or may be attached to one another within an attachment region, which may be glued, welded, or otherwise attached to one another.

[0224] In some embodiments, the shape of the occlusion device is not, and preferably is not, symmetrical.

[0225] In some embodiments, the mounting area is angled relative to the centerline of the closure device.

[0226] 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.

[0227] In some embodiments, the mounting area includes a through-opening. The through-opening may have a closed circumference or may open toward the circumference using its extension. The extension may be narrower than the radius of the through-opening itself. Thus, the extension can change the overall shape of the through-opening into a keyhole shape. The extension may be a bottleneck in one plane to the main area of ​​the through-opening.

[0228] The wires making up the arms of the closure device are preferably made from or comprise flat wire. Flat wire, in contrast to round wire, does not have a circular cross section. Its cross section is oval, rectangular, or otherwise deviates from a circular design. Flat wire allows for a higher gripping force without exceeding the irreversible strain threshold of, for example, Nitinol. The closure device is able to hold the vessel wall with an associated amount of perivascular tissue, clamping it together to create hemostasis and complete closure.

[0229] 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 one 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.

[0230] The retraction device holder described herein may, in some embodiments, be a hollow receptacle or tubing having a lumen for receiving the closure device holder or a portion thereof, which may in turn function as a retraction unit, for example by means of its arms.

[0231] In some embodiments, the closure device is comprised of two previously separate parts, e.g., a first arm and a second arm, which may be attached to one another, e.g., at an attachment region, and which may be formed by or include a straight or non-curved portion.

[0232] The parts or arms may be attached to one another via the attachment areas by one or more rivets.

[0233] The shape of the closure device when deployed and / or in the undeployed state may not be symmetrical, for example, the first and second parts or two arms may be of different designs.

[0234] In particular, the optional asymmetry of the closure device may be achieved by the first and second arms having different radii in their respective curled or closed states, an optional curved portion of the arm that is longer than the optional non-curved portion of the arm, and / or a shift of the attachment region closer to one arm than the other arm within a plane perpendicular to the longitudinal direction of the attachment region or non-curved portion.

[0235] In some embodiments, the closure device, or each of its parts or arms, is preferably made from or comprises a flat wire, and all statements herein relating to flat wire also apply to these embodiments.

[0236] In some embodiments, the mounting area or another portion of the closure device may be shaped, for example, like a "T" or double "T" connected at their legs or crossbars.

[0237] Optionally, there are at least two through openings optionally provided through each crossbar or each mounting area. The through openings may have a closed circumference and may be flush with the non-curved portions of each of the first and / or second arms. The through openings may be suitable for receiving rivets and / or may be designed to receive rivets and / or may receive such rivets.

[0238] In the absence of a double "T" design, it may be advantageous to have differently shaped ends of the arms opposite their free, optionally pointed ends, which may be introduced or inserted into or connected to the tip of a pusher, pusher tube, or any other tool provided for extracting or ejecting the closure device from the closure device holder, and which may be designed to form a close-fitting or form-fitting connection with said tip.

[0239] In some embodiments, the closure device is secured or attached to the pusher to release the closure device from the medical device. The pusher may be pre-tensioned by a spring force. When the spring is allowed to push the pusher forward, the closure device may be ejected. In some embodiments, the attachment, where the closure device is optionally form-fit connected to the tip or front end of the pusher, is automatically lost or released when the tip of the pusher leaves the closure device holder.

[0240] In some embodiments, the tip of the pusher may be designed like a fork with one or at least two prongs bent away from the longitudinal axis and / or advancement direction of the pusher, or other projection or protrusion or portion that blocks the closure device from forming a closure fit (or form fit) in said direction.

[0241] In some aspects, both the connector and the tubing are patent along their length such that a deployment device, e.g., a trocar, can extend through the lumen of the tubing to extend from both ends of the tubing, e.g., the tip and leading end of the deployment device can exit the leading end of the tubing.

[0242] The connector may be disposed at the proximal end of a retraction device holder, which may be suitable and / or designed to releasably receive a deployment device. During use, the deployment device or tube may protrude from the retraction device holder. Both the deployment device and the deployment device holder may be hollow or preferably have the shape of a conical shell, in particular, for receiving an already placed guidewire and for being guided by the guidewire, e.g., through a lumen, into a blood vessel.

[0243] In some embodiments, the deployment device is made from a stiffer material than the retraction device holder.

[0244] In some embodiments, the handle member comprises a piston by which the mechanism for releasing the closure member may be controlled, for example by a user's thumb. One of several through openings for receiving a user's finger or thumb, respectively, may be provided for operating the piston.

[0245] Throughout this specification, a closure device holder, which may be an assembly of multiple closure device holders, for example three closure device holders, may in some embodiments have a flat or thin cross-section in one direction of the cross-section compared to its orthogonal direction.

[0246] In some embodiments, at its distal end, the retraction unit consists of or comprises a lateral arm.

[0247] In some embodiments, the closure device holder emerges directly from the handle member.

[0248] In some embodiments, the closure device holder has only one cross section, or all cross sections have the same area or design.

[0249] In some embodiments, the rocker switch and slider switch are located on the housing or handle.

[0250] In some embodiments, the handle member has a connecting device at its proximal end in the form of a nose or latch designed to engage with a connecting device of a connector, e.g., in the form of a rim. In this respect, other fixed connecting devices are also encompassed by the invention. Also, the latch may be provided on the connector rather than on the handle member.

[0251] In some embodiments, multiple arms are provided at the distal or free end of the closure device holder, with the most lateral arms acting as or part of a retraction unit, and the intermediate arms may help maintain the distance between the closure device and the vessel wall on the opposite side of the hole.

[0252] In some embodiments, some or all of the arms are aligned, or lie in a common plane, or are in contact with, or intersect with, a common plane.

[0253] In some embodiments, the protector has a different shape above and below the arm, which takes into account the asymmetrical design of the closure device and helps protect the vessel from the corresponding arm of the closure device.

[0254] In some embodiments, the lower (distal) end of the casing is shorter at the back than at the top, allowing the lower arms of the closure member to exit first and curl back in first before the upper arms.

[0255] In some embodiments, the closure device can be in an uncurled (or unclosed) or extended state inside the closure device holder of the medical device, whereby the optionally pointed ends of the arms may be directed downward and / or toward the opening of the closure device holder.

[0256] In some embodiments, the closure device may be manufactured from a single piece, preferably rectangular in cross section, for example from a sheet of nitinol that is split longitudinally, preferably partway through its thickness, thus forming two arms.

[0257] In some embodiments, the closure device may be manufactured from a single piece, preferably cylindrical in cross section, for example from a piece of nitinol that is split longitudinally, preferably partway through its thickness, thus forming two arms.

[0258] In some embodiments, the two arms may exhibit different thicknesses, particularly if the longitudinal slit is not located in the center of the cross section of the part.

[0259] In some embodiments, the two arms may alternatively or additionally exhibit different thicknesses along their longitudinal extents.

[0260] In some embodiments, the two arms may exhibit a rectangular cross-section, while in other embodiments the cross-sectional shapes may be different.

[0261] In some embodiments, the two arms may exhibit cross-sections shaped as segments of a circle, while in other embodiments the shapes of the cross-sections may be different.

[0262] In some embodiments, the two arms may have different shapes, dimensions (such as width or length or height), diameters and / or cross sections.

[0263] In some embodiments, the attachment area may be an integral or undivided portion of the closure device.

[0264] In some embodiments, the mounting area can exhibit a number of different cross-sections, widths, lengths, heights and / or diameters so as to be securely retainable in the closure device holder.

[0265] In some embodiments, the attachment area exhibits a T-shape or double T-shape.

[0266] In some embodiments, the mounting area has a cylindrical shape with at least two different diameters, i.e., a wider "head," in certain embodiments, so that it can be securely held in the closure device holder.

[0267] In some embodiments, the shape of the closure device may be symmetrical in the curled state, while in other embodiments it may not be.

[0268] In some embodiments, the closure device may be formed as a one-piece or unitary product.

[0269] In some embodiments, the radii of the two arms in each curled state may be similar or the same, while in other embodiments they may not be, and in embodiments, if the radii are the same, the non-curved portion may therefore be located in the center (or approximately the center) of a circle circumscribing the two arms.

[0270] Using the present invention, it may be possible to replace the typical open method of closing perforations and suturing them tightly, utilizing a single knot or a running surgical suture, a procedure that can be time consuming and has associated disadvantages. [Brief explanation of the drawings]

[0271] [Figure 1] 1 illustrates a hole in a patient's blood vessel and closure with transverse surgical sutures. [Figure 2] FIG. 10 is a side view of another embodiment of a closure device. [Figure 2A] FIG. 3 is a perspective view of the closure device of FIG. 2. [Figure 2B] FIG. 2B shows the closure device of FIG. 2A with a rivet. [Figure 2C] 2B is an enlarged view of the closure device of FIG. 2A secured or attached to a pusher for releasing the closure device from a medical device. [Figure 3] 13A-13C show a connector in a further embodiment penetrated by a deployment device. [Figure 4] 10A-10C illustrate a handle member of a medical device in a further embodiment. [Figure 4A] 10A and 10B show a connector and a handle member with a connection device in an unconnected state. [Figure 4B] 4B shows the connector and handle member of FIG. 4A in a connected state. [Figure 5] 10 is a side view of a portion of a medical device according to a further embodiment of the present invention. [Figure 5A] FIG. 6 is a perspective view of a portion of the medical device of FIG. 5. [Figure 6] FIG. 10 is a perspective view of a proximal portion of the handle member with the rocker switch in a first position; [Figure 6A] 7 illustrates a distal portion of the handle member of FIG. 6 with the rocker switch in a second position. [Figure 6B] FIG. 6B shows an uncoated distal portion of the handle member of FIG. 6A. [Figure 7] 10 is an enlarged view of a portion of the handle member with the slider switch in a first position. FIG. [Figure 7A] 8 shows a portion of the handle member of FIG. 7 with the slider switch in a second position. [Figure 8] FIG. 10 is a perspective view of yet another embodiment of a closure device in an uncurled or stretched state. [Figure 8A] FIG. 9 shows the closure device of FIG. 8 in a curled state. [Figure 9] FIG. 10 is a perspective view of yet another embodiment of a closure device in an uncurled or stretched state. [Figure 9A] FIG. 10 shows the closure device of FIG. 9 in a curled state. [Figure 10] FIG. 10 illustrates a medical device in yet another embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0272] Certain embodiments of the present disclosure are directed to vascular closure devices and methods for closing holes in tissue, such as vascular closure devices comprising a tissue retraction unit and a hole closure member.

[0273] (Organizational pull-in) In one aspect of the present 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 it, 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, and the two long straight sides of the hole are brought closer together in preparation for closure.

[0274] Those skilled in the art will appreciate that vascular closure as described herein follows the principles of surgical vascular closure to prevent narrowing or stenosis of the vessel being treated. The retraction device prepares the hole in the tissue to be a transverse slit perpendicular to the long axis of the vessel, comparable to an open transverse suture. Circular retraction of the hole, such as the open cross-stitch procedure or longitudinal suture shown in FIG. 27, is avoided to avoid stenosis of the vessel being treated.

[0275] (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 recognized that the retraction unit and closure member are not limited to vascular repair and can be used for general tissue repair. It will be understood throughout the remainder of the specification that the closure device of the medical device can be formed from any biocompatible and / or bioabsorbable material, including, for example, titanium (and titanium alloys), nitinol, stainless steel, polymeric materials (synthetic and / or natural), ceramics, etc. It will also be apparent from the specification that the closure device preferably has a needle shape in the form of a loop or circle formed from a deformable shape-memory alloy, such as nitinol. In general overview, the closure device of the present invention undergoes two deformation states: a first state in a compressed, linear configuration in which the closure device is captured within 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.

[0276] 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.

[0277] 27 is a surgeon's view of a hole 302 in a patient's blood vessel 301, showing open 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 constriction 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 FIGS. 10-12 and 22-26, which illustrate exemplary methods of operating the medical device.

[0278] While the specification has been directed to preferred embodiments, it will be understood by those skilled in the art that the disclosure and the description herein are in many respects merely illustrative and not restrictive, and that various modifications and alternative forms may be made. 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 alternatives.

[0279] Therefore, the scope of the present invention is defined in the claims.

[0280] 2 is a side view of yet another embodiment of a closure device 600, which includes two arms 604a and 604b, each with an optionally pointed end 603. The closure device 600 is shown in a curled state, which is the state that the closure device 600 assumes while holding the edges of the hole together (i.e., after being released from the medical device).

[0281] In the exemplary embodiment of FIG. 2, the closure device 600 is comprised of two previously separate pieces, one formed by arm 604a and the other formed by arm 604b. When formed by arms 604a, 604b manufactured independently of one another, arms 604a and 604b may be attached to one another. This can occur via an attachment region 609 that may be formed by or include a straight or non-curved portion 607. That portion 607 is shown in FIG. 2 as an upright, vertical portion. When the closure device 600 is ejected from the medical device and assumes the shape depicted in FIG. 2, portion 607 can assume a position within the patient's tissue similar to that shown in FIG. 2, i.e., portion 607 extends perpendicular to the longitudinal axis of the blood vessel containing the hole 302.

[0282] Arms 604a and 604b may be attached to one another via attachment area 609 by a rivet. Such a riveted configuration can be seen in Figure 2B in contrast to Figures 2 and 2B.

[0283] As can be seen from FIG. 2 (see also FIGS. 2A and 2B), the shape of the closure device 600 need not be symmetrical.

[0284] In the particular example of FIG. 2, the optional asymmetry of the closure device 600 may be achieved by the first arm 604a and the second arm 604b having different radii in their respective curled states, the non-curved portion 607 of arm 604b being longer than the non-curved portion 607 of arm 604a, and / or a shift of the attachment region 609 closer to one arm 604b than to the other arm 604a in a plane perpendicular to the longitudinal direction (vertical extension in FIG. 2) of the attachment region 609 or non-curved portion 607.

[0285] This asymmetry can be useful, for example, when releasing the closure device 600 from a medical device using an optional pusher, such as the pusher tube 808 of the present disclosure. The asymmetry is particularly useful for compensating for different angles when the medical device is inserted, for example, into the hole 302 of a blood vessel (see, for example, FIG. 49A ) at a particular angle that is less than or significantly less than 90°. The medical device may be inserted, for example, at a 45° angle relative to the tissue surface (e.g., which is advantageous to the surgeon because it makes it easier to introduce a portion of the medical device through the hole and into the vessel, for example, along a guidewire).

[0286] The closure device 600, or each of its arms 604a and 604b, is preferably made from or comprises a flat wire, and all statements made in this disclosure relating to a flat wire also apply to this embodiment.

[0287] FIG. 2A shows a perspective view (from the right side) of the closure device 600 of FIG. 2, ie, rotated approximately 45° about the vertical compared to the view shown in FIG.

[0288] As can be seen in FIG. 2A, non-curved portion 607, which may also be referred to as mounting area 609, may optionally be shaped like a double "T" connected by their legs or crossbars.

[0289] Additionally, there are optionally at least two through openings 613 optionally provided through the crossbar, which may have a closed circumference and may be flush with the non-curved portions of the first arm 604 a and the second arm 604 b, respectively, and these through openings may be suitable and / or designed to receive rivets 615 (see FIG. 2B).

[0290] FIG. 2B shows the closure device 600 of FIG. 2A with illustratively two rivets 615 attaching the first arm 604a to the second arm 604b.

[0291] For example, using rivets 615 to attach the first arm 604a to the second arm 604b instead of using welding techniques is advantageously cheaper to manufacture. Additionally, the attachment force between the two arms 604a, 604b can be much stronger compared to welding them together.

[0292] In the absence of a double "T" design, it may be beneficial to have another designed end of the arms 604a, 604b opposite the free, optionally pointed end, that can be introduced into or connected to the tip of a pusher, pusher tube, or any other tool provided for extracting or ejecting the closure device 600 from the closure device holder 802. The end may be designed to form a form-fit connection with said tip. An example of a form-fit connection is shown in and described with respect to FIG. 2C.

[0293] Figure 2C shows one end of each of the first and second arms 604a and 604b as shown in Figure 2, including a non-curved portion 607 of each arm 604a, 604b. A mounting area 609 is provided between the two non-curved portions 607.

[0294] Rivets 615 (see FIG. 2B), which are optional in any case, have been omitted for reasons of clarity.

[0295] 2C shows the closure device 600 of FIG. 2A secured or attached to a pusher for releasing the closure device 600 from a medical device. The pusher may be a pusher tube 808 as disclosed herein or any other pusher. The form-fit connection of the closure device 600 to the tip or front end of the pusher is automatically lost or released when the tip of the pusher leaves the closure device holder 802, as can be derived from FIG. 2C.

[0296] 2C , the tip of the pusher 808 may be designed like a fork with two prongs 808 a, 808 b bent away from the longitudinal axis of the pusher tube 808 and / or the advancement direction L, or may be designed to have other protrusions or projections or portions that lock the T-shaped portion of the closure device 600 to form a close fit (or form fit) in said direction. Since the narrow portion of the T-shaped end of the closure device 600, whether or not it has a T-shaped portion, is merely inserted into a void or receptacle formed at the tip of the pusher, e.g., due to its forked design, and optionally is not further connected, the closure device 600 will come off the tip when it emerges from the closure device holder 802, which until this moment also contains within its lumen the non-curved portions 607 of the tips of each arm 604 a, 604 b of the closure device holder 802. Thus, when advanced out of the lumen, the radial closure fit secured by the inner surface of the closure device holder 802 is lost, and as a result, the longitudinal form fit is similarly lost, causing the closure device 600 to either slip off the tip of the pusher tube 808 or to release from its closure fit with the pusher tube.

[0297] If provided, the prongs 808a, 808b may, in any embodiment, have beveled proximal edges to prevent the closure device 600 from getting stuck and to facilitate release of the closure device 600.

[0298] FIG. 3 illustrates a further embodiment of a connector 500 that is integrated with or connected to a first piece of tubing, also referred to in this disclosure as, but not limited to, a retraction device holder 102. As can be seen in FIG. 3, both the connector 500 and the tubing 102 are patent along their length so that a deployment device 103, e.g., a trocar, can extend through the lumen of the tubing 102 to extend from both ends of the tubing 102. As can be seen in FIG. 3, the tip and leading end of the deployment device 103 exits the leading end 102a of the tubing 102.

[0299] All statements in this disclosure regarding the connector 500, the retraction device holder 102 and / or the deployment device 103 may also apply to the connector 500, the retraction device holder 102 and / or the deployment device 103 of this embodiment.

[0300] The connector 500 is disposed at the proximal end of the retraction device holder 102, which is suitable and / or designed to releasably receive the deployment device 103. During use, the deployment device 103 or tube protrudes from the retraction device holder 102. Both the deployment device 103 and the deployment device holder 102 may be hollow or may preferably have the shape of a conical shell, in particular, for receiving an already placed guidewire and for being guided by the guidewire, e.g., through the bore 302, into the blood vessel.

[0301] In the example of FIG. 3, the deployment device 103 tapers towards its distal end (left side of FIG. 3), although this may be different in other embodiments.

[0302] Preferably, the deployment device 103 is made from a stiffer material than the retraction device holder 102 .

[0303] In contrast to other embodiments, the retraction device holder 102 does not display a retraction device, such as an arm, as may be displayed in other embodiments not shown in this disclosure.

[0304] The connector 500, the tubing 102 and the deployment device 103 may form part of a set according to the invention.

[0305] FIG. 4 shows a handle member 900 of a medical device in a further embodiment.

[0306] All statements in this disclosure regarding the design and use of the handle member 900 and at least some of its mechanisms for pushing or advancing components, such as the retraction device, the closure device 600, etc., may also apply to this embodiment.

[0307] In contrast to the previous figures relating to the handle member 900, the exemplary embodiment shown in Figure 4 comprises a piston 921 by means of which the mechanism for releasing the closure member 600 can be controlled, for example, by the thumb of a user. One or more (here three) through-openings 925 for receiving a finger or thumb, respectively, may be provided for manipulating the piston 921. This exemplary design may be more ergonomic and therefore more comfortable for the user.

[0308] Throughout this disclosure, the closure device holder 802, which may be an assembly of multiple, e.g., three, closure device holders 802, is shown to have a flat cross section. At its tip is shown the retraction unit 100, consisting of lateral arms 101 a and 101 a. In the embodiment of Figure 4, the closure device holder 802 emerges directly from the handle member 900. In the embodiment of Figure 4, the closure device holder 802 optionally has only a single cross section.

[0309] Additionally, the example of FIG. 4 shows a rocker switch 919 and a slider switch 923, which are described in more detail below.

[0310] Figure 4A shows an embodiment of a connector 500 and a handle member 900 having a connection device 500a, 900a for connecting the connector 500 to the handle member 900. In Figure 4A, the connector 500 and the handle member 900 are not connected (disconnected or in a disconnected state).

[0311] In the example of Fig. 4A, the handle member 900 exemplarily shows a connection device 900a in the form of a nose or latch designed to engage with a connection device 500a of the connector 500, which may be a hemostatic valve, provided at its proximal end and having the shape of a rim (see Fig. 3B) to prevent blood leakage after the medical device or part of the medical device has been introduced into the patient's body. In this respect, other fixed connection devices are also encompassed by the present invention. Also, instead of the handle member 900, the latch may be provided on the connector 500.

[0312] Thus, a connection device 500a, 900a may optionally be provided to allow the connector 500 to be connected to the handle member 900, preferably in a releasable manner.

[0313] FIG. 4B shows a state (connected state) in which the connector 500 and the handle member 900 in FIG. 4A are connected by a connection device.

[0314] 5 is a side view of a portion of a closure device holder 802 of a medical device according to a further embodiment. The portion of the medical device is introduced into the lumen of a blood vessel through a hole 302 (not shown) to be closed, with the upper vessel wall 301 shown in simplified schematic lines. The closure device 600, represented by arms 604a and 604b, is partially released.

[0315] The distal or free end of the closure device holder 802 is provided with a number of arms 101 a, 101 b (see FIG. 5A, in this exemplary embodiment, four, although in other embodiments, a greater or lesser number of arms may be provided). The lateral arm 101 a functions as the retraction unit 100 or part thereof. The middle arm 101 b serves to maintain the distance between the closure device 600 and the vessel wall on the opposite side of the hole 302.

[0316] As arm 101a is advanced into hole 302, the arm retracts hole 302 into a slit as described herein. In Figure 5, arms 101a, 101b are shown not covered by a sheath or casing 117 of closure device holder 802 which also includes retraction unit 100 formed by arm 101a.

[0317] In this embodiment, some or all of the arms 101 a, 101 b are arranged in a line, in a common plane, in contact with a common plane, or intersect with a common plane, so that they can allow the hole 302 to expand into a slit shape, while the arms 101 a, 101 b themselves can still be easily pulled out of the slit, since the retraction unit 100, here consisting of two arms 101 a, remains very flat or knife-shaped.

[0318] In some particular embodiments, particularly as described herein, the arms 101a, 101b have different lengths, and the descriptions in this disclosure for the arm 101a of the retraction unit 100 may also be applied to this embodiment.

[0319] 5 also features several optional protectors 101d, each deployed adjacent one of the arms 101b. In some embodiments, the protectors 101d are each connected to either arm 101a or 101b, and one or more 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 upper surface and to the other protector 101d on its lower surface, as may be the case in other example embodiments.

[0320] All statements in this disclosure regarding protector 101d may also be applied to this embodiment.

[0321] In the example of Figure 5, the protector has a different shape above and below arms 101a and / or 101b. This shape takes into account the asymmetric design of closure device 600 (see Figures 2, 2A, and 2B for reference) and helps protect the vessel from the corresponding arms 604a, 604b of closure device 600. Thus, an arm (here, 604a) of closure device 600, which reaches much further out than another arm (here, 604b), which is deployed but not yet closed as shown in Figure 5, is surrounded or covered (in one plane, such as the line drawing of Figure 5, or in a plane parallel to it) by protector 101d, which covers more area as can be seen in Figure 5.

[0322] In the example of Figure 5, the lower (distal) end of the casing 117 is shorter on the rear side (right side of Figure 5) than on the top side (left side of Figure 5). The slope of the casing rim may be defined by an angle α relative to the cross direction of the casing 117 or closure device holder 802. This design, in keeping with the different shapes of the protectors 101d on the upper and lower sides of the arms 101a and 101b, allows the protector 101d on the rear side of the closure device holder 802 to exit the closure device holder proximal to where the opposite protector 101d on the top or front side of the closure device holder 802 exits the closure device holder 802 upon deployment.

[0323] 5 further illustrates that the longitudinal axis of the closure device holder 805 is not disposed vertically within the vessel (represented by the vessel wall 301), but rather is disposed below an angle γ when referring to the top of the closure device holder 805, or below an angle β when referring to the rear of the closure device holder 805, respectively. Typically, β and γ together equal approximately 180°, assuming a flat vessel wall. Thus, the radius and length of the first arm 604a of the closure device 600 may be selected to fill the angle β, which may illustratively be between 0° and 50°, and the radius and length of the second arm 604b may be selected to fill the angle γ, which may illustratively be between 120° and 160°, preferably between 125° and 135°.

[0324] Figure 5A is a perspective view of the medical device of Figure 5. To avoid repetition, reference is made to the description of the previous figures.

[0325] 6 is a perspective view of the proximal portion of the handle member 900 with its optional rocker switch 919 in a first position, in which a mechanism on the handle member 900 prevents the piston 921 from moving into the casing of the handle member 900.

[0326] Figure 6A shows the handle member 900 of Figure 6 with the rocker switch 919 in a second position. In this position, the piston 921 may be pressed or moved in any other manner to release the closure device 600 (not shown) and thereby close the hole 302 in or on the blood vessel. This is represented by the block arrow next to the piston 921.

[0327] Figure 6B shows the handle member 900 of Figure 6. In contrast to the previous views of the handle member 900, the piston 921 and outer shell or cover have been removed for visibility.

[0328] As can be seen, the mechanism for releasing the closure member 600 can include one or more springs 811. This mechanism provides for automatic deployment of the closure device 600 and can be switched to a second position to connect the closure device 600 to the spring mechanism 811, which allows the pushers 808 or their tips to advance to expose the release prongs 808a and 808b and release the closure device 600. Thus, each pusher 808 can be pre-tensioned by force from one or more of the springs 811. The closure device 600 can be ejected when the springs 811 or spring mechanisms are allowed to push the pushers 808 forward.

[0329] 7 is an enlarged view of a portion of the handle member 900. The handle member 900 includes a slider switch 923, the mechanism of which can engage or disengage the closure device 600 from the spring(s), which can resemble a drill or power screwdriver with reverse rotation directions.

[0330] In the example of FIG. 7, the slider switch 923 is in the first position.

[0331] In this position, the closure device 600 is rigidly connected to the closure device holder 802 or a portion thereof, which may advantageously allow the closure device 600 to be re-covered, for example in the case of emergency treatment.

[0332] FIG. 7A shows the portion of the handle member 900 of FIG. 7 with the slider switch 923 in a second position.

[0333] In the second position of the slider switch 923, the closure device 600 is attached to a spring mechanism provided on the closure device holder 802 for release at a desired location, for example to close the hole 302 in the blood vessel 301.

[0334] Preferably, the slider switch 923 remains in its first position until the user is ready for final retraction or automatic deployment of the closure device 600, and is then switched to its second position to attach the closure device 600 to the spring mechanism 811 and cause them to finally deploy within or at the desired position.

[0335] Figure 8 is a perspective view of yet another embodiment of a closure device 600 in an uncurled or extended state, which includes two arms 604a and 604b, each having an optionally pointed end 603. The state of the closure device 600 shown in Figure 8 illustrates a state the closure device 600 may assume within a closure device holder 802 of a medical device (not shown).

[0336] In the illustrated embodiment of FIG. 8, the closure device 600 may be manufactured from a single piece, preferably rectangular in cross section, for example from a sheet of nitinol that is split longitudinally, preferably partway through its thickness, thus forming two arms 604a, 604b.

[0337] In other embodiments, the two arms 604a, 604b can exhibit different thicknesses, especially if the longitudinal slit is not located in the center of the cross section of the part.

[0338] Alternatively or additionally, the two arms 604a and 604b may exhibit different thicknesses along their longitudinal extent.

[0339] Thus, in this embodiment, the mounting area 609 is a unitary or undivided portion of the closure device 600. It can exhibit a number of different cross sections, widths, lengths, heights, and / or diameters so that it can be securely held in the closure device holder 802. The design shown in Figure 8 has a T-shaped or double T-shaped mounting area 609, but is not limited to this.

[0340] As can be seen from Figure 8 (see also Figure 8A), the shape of closure device 600 may be symmetrical, but in this particular embodiment it is not because of the optional difference in length and also the optional difference in shape of the two arms 604a and 604b (see how their ends 603 are differently sharpened). Reference is made to the purposes and advantages of the asymmetrical design of the present disclosure (e.g., with respect to Figure 2).

[0341] In the example of Figure 8, the closure device 600, or each of its arms 604a and 604b, preferably has an at least partially rectangular cross-section. This should not be understood as limiting. Other shapes of cross-section are possible (see, e.g., Figure 9) and are included in the present invention.

[0342] 8, the closure device 600 may be a one-piece device constructed solely from a single piece of material. Thus, this embodiment does not include more than one part, i.e., two or more parts, that must be attached to one another by welding, gluing, etc.

[0343] It should be noted that the closure device 600 of Figure 8 may be formed as a one-piece or unitary product, as may any other closure device disclosed or referred to herein, regardless of any other characteristics thereof.

[0344] Figure 8A is a perspective view showing the closure device 600 of Figure 8 in a curled state, as it appears when holding the edges of a hole together (i.e., after being released from a medical device).

[0345] In the curled state, the attachment region 609 may be formed by or may include a straight or non-curved portion 607. The portion 607 may assume a state within the patient's tissue when the closure device 600 is ejected from the medical apparatus and assumes the shape depicted in FIG. 8A, i.e., the portion 607 may extend perpendicular to the longitudinal axis of the blood vessel containing the hole 302.

[0346] In the particular example of Figure 2, any asymmetry in the closure device 600 is achieved by the first arm 604a and the second arm 604b having different lengths and shapes. In contrast to the embodiment of Figure 2, in this embodiment, the radii of the two arms 604a and 604b in their respective curled states may be similar or the same. This positions the non-curved portion 607 at (or near) the center of a circle circumscribing arms 604a and 604b.

[0347] FIG. 9 is a perspective view of yet another embodiment of a closure device 600 in an uncurled or stretched state.

[0348] Please refer to the description regarding Figures 8 and 8A. To avoid repetition, only the differences with this embodiment will be pointed out.

[0349] In the illustrated embodiment of FIG. 9, the closure device 600 is preferably manufactured from a single piece of cylindrical cross section, e.g., a piece of nitinol that is split longitudinally, preferably halfway through its thickness, thus forming two arms 604a and 604b, each with an optionally pointed end 603.

[0350] This results in a different cross section compared to Figure 8. The mounting area 609 presents a cylindrical shape with (at least) two different circular cross sections, while the two arms 604a and 604b preferably present a cross section shaped like a segment of a circle. This should not be understood as limiting. Other shapes of cross section, for example elliptical, are also possible and included in the present invention.

[0351] Thus, in this embodiment, the mounting area 609 can exhibit a number of different cross-sections, widths, lengths, heights, and / or diameters so as to be securely retainable within the closure device holder 802. The design shown in Figure 9 has a mounting area 609 with a wider "head," but is not limited to this.

[0352] Figure 9A is a perspective view showing the closure device 600 of Figure 9 in a curled state, as it appears (i.e., after being released from the medical device) while holding the edges of the hole together.

[0353] To avoid repetition, reference is made to the above description.

[0354] FIG. 10 shows, in yet another embodiment, a medical device for closing a hole 302, incision, puncture, passageway through tissue, fistula, and / or communication with a blood vessel or other body cavity (or hole for short).

[0355] The medical apparatus comprises one, but preferably only one, closure device holder 802 , in particular containing or arranged to contain exactly one or more closure devices 600 .

[0356] The closure device 600 is releasably housed within a closure device holder 802, which may be designed as disclosed herein.

[0357] Once the surgeon or user decides to correctly position the medical device or its tip to actually close a hole, fistula, etc. by releasing the closure device 600 from the closure device holder 802, a pusher or pusher tube 808 may be provided to push the closure device 600 out of the closure device holder 802.

[0358] To release the closure device 600, a pusher or pusher tube 808, which is also optionally included within the device holder 802, is advanced until the closure device 600 is ejected or pushed out of the opening in the closure device holder 802 at its distal end 804 (e.g., all at once or in stages).

[0359] If the closure device 600 includes a shape memory mechanism, once released, the closure device 600 will assume or return to its original intended shape while gripping and penetrating tissue, thus closing the hole 302, stoma, fistula, etc. Also, once released, the closure device 600 may be separated from the closure device holder 802, e.g., from a connector, mechanism, structure, etc. that releasably connects the closure device 600 to the pusher 808, the closure device holder 802, or any other structure or portion thereof.

[0360] As described above, a mechanism for releasing the closure device 600 can be provided. The mechanism can include one or more springs (not shown in FIG. 10 ). The mechanism can be provided for automatic deployment of the closure device 600 and can be switched to a second position to connect the closure device 600 to a spring mechanism, which allows the pusher 808 or its tip to advance to expose optionally provided release prongs 808 a and 808 b and release the closure device 600. Thus, the pusher 808 can be pretensioned by force from one or more springs (not shown). Alternatively, the pusher 808 can be provided for manual advancement. In some embodiments, the closure device 600 can be ejected when the spring 811 or spring mechanism is enabled to push the pusher 808 forward.

[0361] As can be seen in Fig. 10, the medical device may include a handle 900. The handle may be disposed around the closure device holder 802, as in the example of Fig. 10. The handle 900 may be divided into a first portion 900a and a second portion 900b.

[0362] 10, the first portion 900a and the second portion 900b may be moved toward one another, for example, along a straight line, thus reducing the distance between them. Because a form fit and / or force constraint is provided between the pusher or pushers 808 and the second portion 900b, moving the second portion 900b manually or otherwise causes the pusher or pushers 808 to advance or retract as well.

[0363] In FIG. 10, the first portion 900 a may be form-fit and / or force-constrained with the closure device holder 802 and / or may not be movable relative to the closure device holder 802 .

[0364] Optionally, any type of lock, clamp, etc. may be provided between second portion 900b and first portion 900a or closure device holder 802 to prevent unintentional advancement of second portion 900a and / or pusher or pusher tube 808. Clamps, etc. may be manually removed by the surgeon or user.

[0365] As can be seen from FIG. 10 and as discussed above, retraction units that contact opposite sides of the hole may or may not be included in the medical device, and are not included in the embodiment shown in FIG. [Explanation of symbols]

[0366] 100 Retraction unit 101a Arm 101b Arm 101d Protector 102 Retraction device holder, tubing 102a Front end of tubing 102 103 Deployment Device 117 Casing 301 Blood vessels, blood vessel walls, tissues 302 (blood vessel) hole, slit opening, hole opening 500 Connector, Hemostasis Valve 500a Connected Devices 503 Water washing line, sheath water washing line 600 Closure Device 603 Distal end, pointed end, closure member, tip of closure device, end of closure device 604 Arm 604a Arm 604b Arm 607 Non-curved or straight section 609 Mounting Area 613 Through opening 615 Rivet 800 Closure member 802 Closure Device Holder 803 channels, horizontal channels 808 Pusher tube 808a Prong 808b prong 811 Springs or spring mechanisms 900 Handle material 900a Connected Devices 902 First Slider 919 Rocker Switch 921 Piston 923 Slider Switch 925 Through opening for finger or thumb 2600 sutures B Width L longitudinal axis D R Cross-sectional diameter D N Main shaft length R Radial direction W width α Casing inclination angle β, γ angles between the longitudinal axis and the vessel wall

Claims

1. 1. A medical device for closing a hole (302), incision, puncture, passageway through tissue, and / or communication with a blood vessel or other body lumen (or hole for short) in a patient's tissue (301), 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 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) At least one retraction device holder (102); at least one retraction device preferably at least partially housed within said retraction device holder (102); Equipped with The retraction device is preferably at least partially releasably housed within the retraction device holder (102); The medical apparatus of claim 1 , wherein the retraction device is preferably arranged in a movable or slidable manner relative to the retraction device holder (102).

3. At least one closure device (600), The medical device of claim 1 or 2, wherein the closure device (600) can be in an uncurled (or unclosed) or extended state inside the closure device holder (802), and the optionally pointed ends of the arms of the closure device (600) are directed downward and / or toward the opening of the closure device holder (802).

4. 4. A medical device according to any one of claims 1 to 3, comprising at least one closure device (600), preferably manufactured from a single piece of rectangular cross section, for example from a sheet of nitinol that is split longitudinally, preferably split midway through its thickness, thus forming two arms (604a, 604b).

5. 5. A medical device according to any one of claims 1 to 4, comprising at least one closure device (600) comprising two arms (604a, 604b) of different thicknesses, particularly when the longitudinal slit is not located in the center of the cross section or depth of the one-piece.

6. The medical device of any one of claims 1 to 5, wherein the two arms (604a, 604b) exhibit different thicknesses along their longitudinal extent.

7. The medical device according to any one of claims 1 to 6, wherein the two arms (604a, 604b) present a rectangular cross section.

8. The medical device of any one of claims 1 to 7, wherein the two arms (604a, 604b), when deployed at least once, present a cross section shaped as a segment of a circle.

9. The medical device according to any one of claims 1 to 8, wherein the two arms (604a, 604b) differ in their shape, size, diameter and / or cross section.

10. The medical device of any one of claims 1 to 9, wherein the attachment area (609) may be an integral or undivided part of the closure device.

11. The medical device of any one of claims 1 to 10, wherein the mounting area (609) exhibits two, three, four or more different cross sections, widths, lengths, heights and / or diameters.

12. The medical device according to any one of claims 1 to 11, wherein the mounting area (609) presents a T-shape or a double T-shape.

13. A medical device as described in any one of claims 1 to 12, wherein the mounting area (609) in certain embodiments has at least two different diameters, i.e., a cylindrical shape with a wider "head", so that it can be securely held in the closure device holder.

14. The medical device of any one of claims 1 to 13, wherein the shape of the closure device (600) is symmetrical in the curled state.

15. The medical device of any one of claims 1 to 14, wherein the shape of the closure device (600) is not symmetrical in the curled state.

16. The medical apparatus of any one of claims 1 to 15, wherein the closure device (600) is formed as a one-piece or monolithic product.

17. 17. The medical device of any one of claims 1 to 16, wherein the radii of the two arms (604a, 604b) in their respective curled states may be similar or the same, but may otherwise be dissimilar or unequal.

18. 18. The medical device of claim 1, wherein the radii are the same and the non-curved portion is located at the center (or approximately the center) of the circle circumscribing the two arms (604a, 604b).

19. A method for closing a hole in tissue (302), comprising: Providing a medical device according to any one of claims 1 to 18, comprising a retraction device holder (102), a retraction device having a first arm (135) and a second arm (137) or a closure device holder (802) functioning as a retraction device, and a deployment device (103); and inserting the deployment device (103) into the lumen of the retraction device holder (102).

20. pushing both the deployment device (103) and the retraction device holder (102) forward into the hole (302) until at least a portion of the deployment device (103) within the lumen of the retraction device holder (102) is positioned inside the hole (302) or within the blood vessel (301); withdrawing the deployment device (103) from the lumen of the retraction device holder (102); inserting the closure device holder (802) having the closure device (600) into the lumen of the retraction device holder (102), preferably of a mostly elliptical or oval shape, and positioning one or more distal openings of the closure device holder (802) in the hole (302) for ejecting the closure device (600) from the closure device holder (802); and pushing, releasing, or withdrawing the closure device (600) from the closure device holder (802) to close the hole (302).

21. A method for closing a hole in tissue (302), comprising: Providing a medical device according to any one of claims 1 to 19; and closing the hole (302) with the medical device.

22. A closure device (600) for closing a hole (302), incision, puncture, tissue passage, and / or communication with a blood vessel or other body lumen (abbreviated hole) in a patient's tissue (301), the closure device (600) comprising two, at least two or more arms (604, 604a, 600b) for penetrating the tissue (301).

23. It is a set, a closure device holder (802) as described herein; a retraction device holder (102) as described herein; a deployment device (103) as described herein; A set consisting of or comprising a medical device according to any one of claims 1 to 19, optionally with a further guidewire (1000).

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