Medical device and method for closing an opening in tissue

Abstract

The present invention relates to a medical device for closing an opening (302), an incision, a puncture, a duct passing through the tissue and / or a communication port with a blood vessel or other body cavity (hereinafter referred to as an opening) in a patient's tissue (301), the medical device comprising: a closing device holder (802) for releasably receiving and / or holding one or more closing devices (600); and a retraction unit (100) for contacting opposite sides of the opening (302) and for retracting the opposite sides and / or for expanding the opening (302) so that the shape of the opening (302) changes to a slit opening or a slit-like opening or more like a slit opening (302), or for expanding or increasing the size or diameter of the opening (302) in at least one or exactly one dimension of the opening (302).

Description

Technical Field

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

[0002] The present invention generally relates to medical devices (referred to as: devices) and methods for engaging tissue and / or closing openings through tissue as an alternative to suturing, and more particularly for closing openings in blood vessels or other body lumens; and more particularly to a closure device for use in closing openings in the walls of body organs or blood vessels, particularly after invasive surgery in a patient's system, and corresponding methods of use. Background Art

[0003] There are several interventional procedures, which are usually performed by puncturing and inserting a hollow needle in a blood vessel or other body organ, and then a guide wire can be advanced through the needle lumen into the patient's blood vessel or other organ. The guide wire can be advanced through the needle, and the needle can be removed, and an introduction cannula can be advanced over the guide wire into a blood vessel or other body organ (Seldinger technique). Such cannulae are usually flexible tubes with thin walls and a diameter up to about 30F or larger, matching the needs of the therapeutic system utilized. The proximal end of the cannula remains outside the patient's skin and is usually used with a hemostatic valve to prevent blood from flowing through the cannula from the blood vessel. Then, a catheter or other device can be passed through the lumen of the introduction cannula and advanced over the guide wire to the position for performing medical surgery. Puncture is used for several reasons, including but not limited to diagnostic cardiovascular surgery, coronary and peripheral angioplasty or stenting, heart valve prosthesis implantation and heart valve repair, thoracoscopic surgery, laparoscopic surgery or endoscopic surgery, etc. These procedures all require puncturing a body organ or blood vessel wall for treatment of the patient's system. The size of the puncture will vary depending on the procedure and the system being inserted. Depending on the procedure, the femoral artery or vein is typically used as the entry point into the patient's system. Typical puncture diameters can range from 2 mm to greater than 10 mm, or from 6 French (Fr) to greater than 30 French (Fr) for interventional procedures.

[0004] Other procedures, such as those encountered when using an endoscope or other instruments, may utilize a trocar for insertion. Typical trocar puncture diameters range from 2 mm to greater than 15 mm, or from 6 French (Fr) to greater than 45 French (Fr). Closure of such openings is typically achieved using multi-level surgical sutures.

[0005] Following completion of an interventional diagnostic or therapeutic procedure utilizing a vascular puncture as an access site, whether to the peripheral circulation, coronary system, or heart, the device and introducer cannula are removed, leaving a puncture site in the vessel wall or body organ.

[0006] Such perforations can be closed and tightly sutured using common open surgical methods utilizing either a single knot or a continuous surgical suture.

[0007] The alternative open surgery of hemostasis is to use clips (clips) or U-shaped staples (staples).March et al. show a form of hemostatic clip in U.S. Patent No. 4,217,902, which requires an open surgical access with a perforation to allow the clamping mechanism to operate.And, more complicated surgical staplers are described, as shown in U.S. Patent No. 2008 / 272173 of Coleman James et al., which require an open access.

[0008] Various procedures and devices have been developed to address the problem of hemostasis following vascular puncture for diagnostic or therapeutic procedures in a closed, non-surgical manner.

[0009] A common way to stop bleeding is to apply pressure to the puncture site and wait for the patient's natural coagulation and self-healing properties to close the blood vessel opening. This pressure requires a relatively long time, for example 30 minutes to up to 1 hour, during which the patient is then bedridden, essentially unable to move, and a heavy sandbag is placed on the puncture site to provide compression for several hours until the bleeding stops. Before complete hemostasis and sealing occur, there is an additional risk of hematoma in the bleeding. This operation can be time-consuming and has associated disadvantages.

[0010] As the size of a vascular perforation increases, such as in a heart valve prosthesis implant or heart valve repair system, compression of the perforation and natural sealing of the pending opening becomes less effective or even ineffective.

[0011] Although excessive bleeding may occur in patients with normal coagulation responses, some patients are taking anticoagulant medications to inhibit coagulation, have bleeding disorders, hypertension, or obesity, which increase the risk of excessive bleeding after removal of the penetrating cannula or treatment system.

[0012] One way to improve hemostasis is through the application of collagen or polymer plugs, as shown in U.S. Pat. No. 5,275,616. This procedure is particularly effective in smaller perforations. However, the placement of such embolic materials increases the risk of intravascular thrombosis and the development of inflammatory reactions.

[0013] Various percutaneous clips or staplers have been developed to avoid open access closure. The system is inserted over an already utilized guidewire and the clip is applied percutaneously.

[0014] Various percutaneous suturing systems have been developed that have closure systems that provide multiple needles joined by sutures. After each needle has passed through the vessel wall around the opening, it is grasped, withdrawn outward, knotted, and the knot is pushed back through the tubing to complete the closure. The placement of the suture needles requires sufficient engagement of the tissue so that the placed sutures can grasp and close the hole, which limits the system to closing relatively small vascular perforations.

[0015] In surgeries involving perforation of body cavities and organs (e.g., thoracoscopic, laparoscopic, or endoscopic surgeries), the patient's body is typically accessed using a trocar of appropriate size that is large enough to accommodate the appropriate system. Closure of such large-caliber perforations is typically accomplished through open surgical suturing. Summary of the Invention

[0016] The present invention aims to provide another medical device and method for closing an opening and also to provide a closing device.

[0017] This object is achieved, for example, by a medical device for closing an opening having the features according to claim 1. This object is further achieved by a method for closing an opening having the features according to claim 25 and a closing device having the features according to claim 26.

[0018] In all the above and following statements, the expressions “may be” or “may have” etc. used should be understood as being synonymous with “preferably is” or “preferably has” etc., respectively, and are intended to illustrate embodiments according to the present invention.

[0019] Whenever a numerical term is mentioned herein, a person skilled in the art should recognize or understand it as an indication of a lower limit of the numerical value. Therefore, unless this leads to a contradiction obvious to a person skilled in the art, a person skilled in the art should understand, for example, "one" to include "at least one". The present invention also includes the following interpretation of this understanding: for example, a numerical term such as "one" can alternatively mean "exactly one", as long as this is obvious to a person skilled in the art and technically feasible. The present invention includes both interpretations and the interpretations apply to all numerical terms used herein.

[0020] If the subject matter of the present invention is disclosed herein to include one or more features in a specific embodiment, the subject matter according to that embodiment is also disclosed herein to expressly exclude that one or more features in other embodiments also according to the invention, e.g., in the sense of a disclaimer. For each embodiment mentioned herein, the contrary embodiment is also disclosed, e.g., as a negation.

[0021] Accordingly, the present invention provides a medical device for closing an opening, incision, puncture, duct through tissue, and / or communication with a blood vessel or other body lumen (hereinafter referred to as an "aperture") in a patient's tissue. Herein, the medical device includes a closure device holder for releasably receiving and / or retaining one or more closure devices. The medical device also includes a retraction unit. The retraction unit can be designed or configured to, during use of the medical device, preferably contact opposite sides of the tissue of the opening to retract the opposite sides or tissue and / or expand the opening, thereby optionally causing the opening to change its shape to a slit-like or slit-like or more slit-like opening. To this end, or to achieve this purpose, the retraction unit can be appropriately configured. For example, such retraction or such change can be achieved by increasing the gap or distance between parts of the retraction unit (e.g., between the retraction device or its arms (if provided) or its tips), which in turn can result in an expansion or increase in the size or diameter of the opening in at least one, or precisely one, dimension of the opening.

[0022] Furthermore, a method for closing an opening in tissue is proposed, said method comprising firstly the step of providing a medical device according to the invention and secondly the step of closing the opening by using said medical device.

[0023] Advantageous developments of the invention are the subject matter of each of the several dependent claims and the embodiments.

[0024] Whenever an embodiment is mentioned herein, this represents an exemplary embodiment according to the present invention. Whenever an invention is mentioned herein, this represents the present invention.

[0025] Embodiments according to the invention may comprise one or more of the features mentioned above and / or below in any technically feasible combination.

[0026] In some embodiments, a retraction unit of a medical device according to the present invention comprises at least one retraction device holder and at least one retraction device. The at least one retraction device may preferably be at least partially received in the retraction device holder. The retraction device may optionally be at least partially received in the retraction device holder, preferably releasably, and preferably movably or slidably disposed therein relative to the retraction device holder.

[0027] The retraction device holder may have a distal end and a proximal end, the distal end preferably being configured to be advanced or extended through or into an opening to be closed.

[0028] In several embodiments, the retraction unit of the medical device according to the present invention comprises at least one engagement means connected to said retraction means for releasably engaging with tissue.

[0029] In some embodiments, the engagement means may have a closed section with a through opening. The closed section may have a rectangular, square, circular, oval or a combination thereof.

[0030] In several embodiments, the engagement means may comprise or consist of a wire.

[0031] In some embodiments, the engagement means may be formed from a single wire.

[0032] In several embodiments, the engagement means may have or cover a convex or concave shape. In other embodiments, the engagement means is flat or substantially planar.

[0033] In some embodiments, the engagement means of a medical device according to the present invention is configured to be foldable and / or to be at least partially contained or captured within a retraction device holder.

[0034] A mechanism may be provided for moving the engagement means and / or the retraction means into or out of the retraction means holder.

[0035] In several embodiments, an engagement device can be coupled to the retraction device described above such that it is configured to engage tissue surrounding the stoma from within or from below the stoma opening.

[0036] In some embodiments, at least two retraction devices and / or at least two engagement devices of the medical device according to the present invention are releasably captured in the retraction device holder. Specifically, they are captured so that they are arranged to be at least partially released from the retraction device holder by manipulating the retraction device holder, or the engagement devices, or a mechanism configured to perform such manipulation when necessary, in particular to be placed below the opening level of the opening to be closed.

[0037] In several embodiments, the retraction device holder and / or the retraction device and / or the engagement device of the medical device according to the present invention are configured to retract opposite sides of the opening, specifically to cause the opening to change its shape. For example, the opening can be changed from a relatively round shape to a slit opening. Preferably, this results in an extended transverse diameter that is at least twice the length of the retracted longitudinal diameter of the opening. "Transverse" can refer to a direction perpendicular to the longitudinal direction of the blood vessel. The longitudinal diameter can extend in the direction of the longitudinal axis of the blood vessel.

[0038] In some embodiments, the retraction unit of the medical device according to the present invention comprises at least one retraction device having at least one of the following:

[0039] - a first side and an opposite second side,

[0040] - first arm and second arm,

[0041] - a first retraction device and a second retraction device,

[0042] - a first retraction device holder and a second retraction device holder, and / or

[0043] - a first engagement means and a second engagement means.

[0044] In addition, the retraction unit or any other component may have a mechanism for moving the first side away from or away from the second side, moving the first arm away from or away from the second arm, moving the first retraction device away from or away from the second retraction device, moving the first retraction device holder away from or away from the second retraction device holder and / or moving the first engaging device away from or away from the second engaging device.

[0045] In several embodiments, the mechanism comprises or consists of shape memory properties.

[0046] In some embodiments, the mechanism may include or consist of mechanical components, including, for example, gears, levers, actuating members, control members (eg, knobs or handles), and the like.

[0047] In some embodiments, the optional knob and / or handle member or handle member sleeve of the medical device (or at least a portion thereof, respectively) is made of resin, plastic, fiberglass, wood, metal, or a combination of materials mentioned herein. In other embodiments, the optional knob and / or handle member or handle member sleeve of the medical device (or at least a portion thereof, respectively) is not made of resin, plastic, fiberglass, wood, metal, or a combination of materials mentioned herein.

[0048] In some embodiments, the handle member or its sleeve includes at least one slider, for example, to provide a user with a slider. In other embodiments, no slider is included.

[0049] In some embodiments, the handle member or its sleeve includes at least one rotational component, for example, to provide a user with a means to convert rotation into translation. In other embodiments, no such rotational component is included.

[0050] In several embodiments, the mechanism may include or consist of a vacuum device configured to modify the shape of the retraction device, retraction unit, or any other component so that the first side or first arm, etc. moves away from or away from the second side or second arm, etc.

[0051] The vacuum device may be arranged to draw a fluid (e.g. air) from an internal lumen (preferably closed) of, for example, a retraction unit, such that the cross-section of the component (e.g., the retraction unit) is altered: by attempting to achieve a vacuum within the lumen, for example, the cross-section of the retraction unit will increase in a first dimension but decrease in a second dimension perpendicular to the first dimension. In this way, for example, opposing first and second sides of the retraction unit will move away from each other, while the circumference of the retraction unit remains constant.

[0052] The preferably closed lumen in fluid communication with the vacuum device may, in at least one state (whether vacuum is applied or not), have a cross-section that is longer in a first direction thereof than in a second direction perpendicular to the first direction.

[0053] In some embodiments, the retraction unit or retraction device has a bend or step, or it is curved on its front side or on its rear side so that it can serve as a stop or provide tactile feedback to the surgeon when partially withdrawing the medical device from the blood vessel lumen. The bend, step, etc. can indicate that the tip of the medical device or its retraction unit, retraction device, etc. has stopped at the edge of the blood vessel or opening. This in turn indicates that the medical device is in a suitable position for deploying the closure device. To achieve this, the bend, step, etc. is arranged below a predetermined distance from, for example, the free end of the medical device or retraction device. In addition, the bend, step, or position that makes the bend serve as a protection to prevent the medical device from being pulled too far out of the blood vessel lumen before releasing the closure device.

[0054] In some embodiments, the medical device does not include a vacuum device or source and / or is not connected to such a device or source.

[0055] In some embodiments, the medical device is not a pressure stabilizer.

[0056] In several embodiments, portions of the retraction device (eg, tips of its arms, if provided) deflect or separate from one another when in a released or unstressed state and / or for retracted release.

[0057] In some embodiments, portions of the retraction mechanism (e.g., the two arms or the tips of such arms, if provided) deviate from or separate from each other in a released or unstressed state and / or for retracting the device in a common plane. The longitudinal axis of the handle member may be a portion of such plane or at an angle of less than 10°, 15°, or 20° to such plane.

[0058] In several embodiments, the retraction device and the closure member or portions thereof, respectively, are at least partially retractable from the same handle member.

[0059] In some embodiments, the retraction unit is designed to contact, for example on two opposite sides, the opening or the tissue surrounding the opening to retract the opening or the tissue surrounding the opening and / or to expand the opening, thereby causing the opening to change its shape into a slit opening or a slit-like opening or more like a slit opening, or to expand or increase the size or diameter of the opening in at least one or exactly one dimension of the opening by enlarging the space or gap between the parts of the retraction unit, for example, by moving the arms of the retraction device or the tips of the arms (if provided) apart from each other.

[0060] In several embodiments, a medical apparatus according to the present invention comprises at least one closure device contained in a closure device holder.

[0061] In some embodiments, the closure device of a medical device according to the present invention is at least partially contained within the closure device holder when the closure device is in a stressed state. Specifically, the closure device is contained within the distal end of the closure device holder, particularly when the closure device is in an undeployed state. In this context, the closure device preferably has two or more ends and a joint connected to the two or more ends, for example, via two or more arms.

[0062] In several embodiments, the closure device of the medical device according to the present invention is contained within a closure device holder such that when the closure device is manipulated to withdraw from the distal end of the closure device holder during use of the medical device, the closure device releases stress or a portion thereof, for example, by bending the two or more arms outward from the closure device holder. Thus, the two or more arms are arranged to perforate the inner wall of tissue surrounding the opening.

[0063] In some embodiments, at least a portion of the closure device, retraction device, retraction device retainer and / or engagement device of a medical device according to the present invention is made of a deformable shape memory alloy and / or has a self-expanding shape memory segment or wire body.

[0064] In several embodiments, at least a portion of the closure device, retraction device, retraction device retainer, and / or engagement device of a medical device according to the present invention is made of Nitinol.

[0065] In some embodiments, at least a portion of the closure device, retraction device, retraction device retainer and / or engagement device of a medical device according to the present invention is made of a biocompatible and / or bioresorbable material.

[0066] In some embodiments, the biocompatible and / or bioresorbable material is at least one material selected from the group consisting of titanium (Ti), titanium alloys, Nitinol, stainless steel, polymeric materials, and ceramics.

[0067] In some embodiments of medical devices according to the present invention, the closure device or portion thereof is curled into a closed form (eg, having an opening surrounded by arms, struts, etc. of the closure device) when in an unstressed state.

[0068] In several embodiments of the medical device according to the present invention, the closure device or a portion thereof is curled into a loop or ring or circular shape when in an unstressed state.

[0069] In several embodiments of the medical device according to the present invention, the deployed closure device has a cross-sectional dimension ranging from 10 microns to 1 centimeter, preferably from 40 microns to 200 microns, more preferably from 50 microns to 100 microns.

[0070] In some embodiments, the closure device has two arms.

[0071] In some embodiments, at least one arm has a first bending direction and a second bending direction. Thus, a first portion of the arm bends in the first bending direction, while a second portion of the arm bends in the second bending direction, wherein the first bending direction and the second bending direction are at least one of non-identical, opposite, and away from each other.

[0072] In some embodiments, in the closed state of the closure device or vascular ostium, the end or tip of a first of the arms points away from a second of the arms, and the end or tip of the second arm points away from the first arm.

[0073] In some embodiments, the medical device comprises or consists of a handle component (or handle or handle arrangement).

[0074] In some embodiments, the handle member may have a first slider and optionally also a second slider configured to be moved by a user, preferably in a longitudinal direction of the handle member, in order to activate or advance the retraction device.

[0075] Alternatively, at its end or another position, the first slide may be locked in position.A suitable mechanism may be provided, for example, in the handle part.

[0076] In some embodiments, all or some of the closure device retainers are completely parallel to each other or only partially parallel.

[0077] In some embodiments, the sleeve of the handle member includes an opening in which a user can move a switch to advance the closure device retainer relative to the sleeve of the handle member.

[0078] In some embodiments, the closure device holders are configured to remain parallel to each other throughout the closure of the vessel opening. In other embodiments, they are configured to separate or deviate from each other when advanced toward the vessel opening.

[0079] In some embodiments, the closure device retainers are not parallel to each other, or only portions (e.g., their proximal ends) are parallel except for their distal ends (e.g., their tips). In certain embodiments, the proximal ends are parallel to each other. In some embodiments, the distal portions are at an optionally constant angle relative to each other.

[0080] In some embodiments, the distance between the tips or distal ends of some closure device holders (eg, when advanced toward a vascular opening for closure) is greater than the diameter of an opening or handle component of a medical device from which the closure device holder is withdrawn to close the vascular opening.

[0081] In certain embodiments, the distance between the tips or distal ends of the closure device holders, or other corresponding portions of the closure device holders, is equidistant between adjacent closure device holders when in an unstressed or fully deployed state and / or when advanced to close a vascular opening.

[0082] In certain embodiments, the distance between the tips or distal ends of some retraction devices or their arms (e.g., when advanced toward a vessel opening for closure or in an unstressed or fully deployed state) is greater than the distance between the tips or distal ends of some closure device retainers described above.

[0083] In some embodiments, a delivery stent is provided for ensuring that the closure device retainers are deflected or separated from each other as they are advanced toward the vessel stoma.

[0084] In some embodiments, the delivery stent comprises or consists of a wire, a wire mesh or a structure, respectively.

[0085] In some embodiments, the delivery stent is a foldable and / or deployable component.

[0086] In some embodiments, the bumper is disposed on the outside or side of the closure member or closure device holder or transfer bracket.

[0087] In some embodiments, the handle part comprises a sleeve or another component, preferably a rotatable component or a cylindrical component, which has a guide groove (slot / groove) that is optionally U-shaped or V-shaped. The guide groove can be a part of the outer surface of the sleeve or can be added to the latter.

[0088] In some embodiments, the guide channel includes a first channel segment and a second channel segment, each channel segment being connected to each other by another channel segment referred to as a turning point.

[0089] In some embodiments, the handle member, knob or sleeve itself comprises a resilient member, spring or the like, arranged to guide the pin through the turning point of the guide slot.

[0090] In some embodiments, the retraction device comprises a plurality (here two) arms.

[0091] In some embodiments, the arm of the retraction device includes two legs, referred to as an outer leg and an inner leg.

[0092] In some embodiments, the outer leg and the inner leg may be welded to each other through or in the weld.

[0093] In some embodiments, the outer and inner legs surround or enclose one or two central openings (which may be through-ports), or form the latter therebetween.

[0094] In some embodiments, the inner leg is straight or substantially straight.

[0095] In some embodiments, the outer foot is curved so as to have or form an indentation, protrusion, or depression.

[0096] In some embodiments, the arms of the retraction device each exit through a respective opening of the retraction device. In other embodiments, some or all of the arms exit through a common opening of the retraction device.

[0097] In some embodiments, at least one opening of the retraction unit through which the arm exits in use is smaller in width than in length.

[0098] In some embodiments, the opening in the retraction device through which at least one arm exits has an elliptical opening area.

[0099] In some embodiments, the medical device according to the present invention further comprises a pushing device, which preferably extends through the proximal end of the closure device holder for manipulating the closure device. The pushing device can be configured not to deform the closure device by acting on the closure device (e.g., by pushing the closure device).

[0100] In several embodiments of the medical device according to the present invention, the pushing means is or comprises a rod or a piston.

[0101] In some embodiments, the medical device according to the present invention further comprises a holding or retraction device extending through the proximal end of the closure device holder for manipulating the closure device. In this context, the holding device is specifically releasably attached to or connected to the closure device.

[0102] In several embodiments, the retaining means of the medical device according to the present invention is a string or a suture.

[0103] In some embodiments, the closing device holder of the medical device according to the present invention has one or more grooves on the inner wall of the closing device holder and / or one or more grooves on the pushing device for guiding the holding device along the longitudinal direction of the closing device holder, preferably through or along (multiple) grooves.

[0104] In several 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 manipulation of the medical device or upon user request. Each end can exit from one or both sides of the closure device holder. The channels can be slit-like. The channels or their proximal ends can be extended distally from the closure device holder.

[0105] In some embodiments of the medical apparatus according to the present invention, the distal end of the closure device holder has at least one channel or two channels arranged opposite each other on a wall of the closure device holder, in particular on the circumference of the closure device holder.

[0106] In several embodiments of the medical apparatus according to the present invention, the retraction device holder is or comprises an elongated tube. The elongated tube comprises or consists of, for example, metal or plastic and is preferably configured to grasp the retraction device.

[0107] The closure device holder may have a distal end for advancement or extension through or into the opening in tissue and a proximal end particularly adapted to provide a passage for manipulation of the closure device once received.

[0108] In some embodiments, at least one of the closure device retainer and the retraction unit is at least one of: slidably and movably arranged within the medical device relative to each other, relative to other components of the medical device and / or relative to a cannula or outer sheath of the medical device.

[0109] In some embodiments, the medical device includes a housing, sheath or cannula that includes some or all components of the medical device (except, of course, the housing or cannula, etc.), specifically the closure device holder and / or the retraction unit.

[0110] In some embodiments, the medical device includes a lumen for guiding and / or enclosing a guidewire. The lumen can be open to both the distal and proximal ends of the medical device, or only to one of them.

[0111] In some embodiments, the medical device includes multiple lumens or openings. For example, one of the lumens or openings can house a first closure device holder, and another can house a second closure device holder, a retraction device holder, and / or any other components of the medical device.

[0112] Any inner cavity of the medical device may be an opening of the medical device, preferably extending in the longitudinal direction of the medical device.

[0113] In some embodiments, the medical device has a housing or unit that is inflexible and / or flexible along its entire length or only along a portion of its length.

[0114] In several embodiments of the method according to the present invention, the method comprises the following further steps:

[0115] - introducing parts of the retraction unit into the opening;

[0116] - bringing opposite sides of the opening into contact with the retraction unit or components comprised therein;

[0117] - using the retraction unit or the components it comprises to retract the opposite sides of the opening and / or expand the opening; and

[0118] - releasing at least one closure device from a closure device holder and connecting opposite sides of the opening to each other using the closure device.

[0119] In some embodiments of the method according to the present invention, the steps of retracting the opposite sides of the opening and / or expanding the opening cause the opening to change its shape, for example, to become a slit opening or a slit-like opening or more slit-like opening. Such a change may result in expanding or increasing the size or diameter of the opening in at least one or exactly one dimension of the opening.

[0120] In some embodiments, at least one of the closure device retainer and the retraction device retainer is a partially hollow tube.

[0121] In some embodiments, at least one of the closure device retainer and the retraction device retainer is disposed within a common sleeve or housing, preferably slidable or movable relative to said sleeve.

[0122] In some embodiments, the closure member is identical to the closure device holder.

[0123] In some embodiments, the retraction unit is identical to the retraction device holder.

[0124] In some embodiments, the retraction unit and the closing member are implemented by only one device.

[0125] In some embodiments, the device does not have a guidewire. However, the device may have a lumen for passing a guidewire through the length of the device and / or continuing in the length direction thereof.

[0126] In some embodiments, the closure device is a staple or a clip or a wire structure, etc. Any combination thereof may have any of the features disclosed herein.

[0127] In some embodiments, the closure device holder is not configured to eject or release a closure device, in particular a staple or clip, in a first direction, wherein the device or component of the closure device holder configured to eject or assist in ejecting the closure device is arranged to be movable preferably (or ideally only) in the first direction or preferably substantially in the first direction. However, in those embodiments, the component is not configured or arranged to be movable in a second direction that is substantially perpendicular to the first direction.

[0128] In some embodiments, at least one of the closure device holder and the device does not have a device configured to plastically deform the closure device, in particular not for plastically deforming the closure device when ejecting or releasing. In addition, preferably no device for closing the closure device is provided.

[0129] In some embodiments, the closure device holder is configured to eject or release two or more closure devices simultaneously. For example, the closure devices may be ejected from a common opening in the holder, and the closure devices may exit side by side through the common opening. Alternatively, the configuration may allow two or more closure devices to exit the closure device holder or device simultaneously through separate openings.

[0130] 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.

[0131] 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.

[0132] In some embodiments, the retraction unit comprises at least two components, such as two sides, two arms, two retraction devices or two retraction device holders, which move apart from each other when retracting the aperture.

[0133] In some embodiments, the retraction unit and the closure device holder are separate from each other and, in particular, movable separately from each other. In other embodiments, the retraction unit and the closure device holder are interconnected or implemented by the same unit so that they cannot be moved independently of each other.

[0134] In some embodiments, the retraction unit and the closure device holder are spaced apart from each other so that the closure device holder is configured to pop out or release one or more closure devices into the tissue so that they close the edges or seams of the long sides of the opening when the opening is in a retracted state, i.e., when the opening is retracted or expanded by the retraction unit.

[0135] In some embodiments, at least one of the components of the retraction unit configured to retract the opposite side of the opening by directly touching the opposite side of the opening is an elongated or rectangular section. At least one of the components may have the shape of a rod, a tube, etc., and it is preferably straight.

[0136] In some embodiments, at least one of the components of the retraction unit that is configured to retract the opposite sides of the opening by directly touching the opposite sides of the opening (for example, the first arm or segment and the second arm or segment, the first retraction device and the second retraction device, the first retraction device holder and the second retraction device holder and / or the first engagement device and the second engagement device) does not include one or more hinges, joints, joints or segments at its bend, specifically in its middle section, and more specifically in opposite directions facing each other.

[0137] In some embodiments, the component of the retraction unit configured to retract the opposite side of the opening by directly touching the opposite side of the opening has a free remote end.

[0138] In some embodiments, some or all components of the retraction unit that are configured to retract opposite sides of the opening by directly touching the opposite sides of the opening are configured to move relative to each other in a first common plane while retracting the opening. 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). In addition, the closure device may be closed in the second plane as desired. 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., the second plane). The first plane and the second plane may intersect each other. The first plane and the second plane may be substantially perpendicular to each other.

[0139] In some embodiments, some or all of the components of the retraction unit configured to retract opposite sides of the opening by directly contacting the opposite sides of the opening are configured to move relative to each other in a first direction while retracting the opening. Optionally, in these or different embodiments, the device is configured to eject or release at least one closure device in a second direction. The first and second directions may be different from each other. In fact, the first and second directions may be perpendicular or substantially perpendicular to each other. Thus, the direction of retraction 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 surgeon uses the device.

[0140] In some embodiments, the first and second retracting devices or their first and second arms or segments are connected to each other only by a hinge or joint or a hinge or joint segment. The hinge or joint or segment can be arranged to preferably move only within the retracting device holder and / or along the longitudinal axis of the medical device or retracting device holder. In addition, or as another option, the hinge or joint or segment can be arranged to preferably move only in the second direction, but not in the first direction. Therefore, in those embodiments, the hinge or joint or segment can optionally not move in the direction of being retracted or expanded on the opposite side of the aperture.

[0141] According to the present invention, a medical device for closing an opening in tissue is also provided, comprising:

[0142] a closure device holder, wherein the closure device holder has a distal end for extending through an opening in tissue in a deployed state of the medical device and a proximal end for providing access for manipulating the closure device; and

[0143] - a closure device, at least partially captured in a stressed state within a distal end of the closure device holder when the medical device or closure device is in an undeployed state; wherein the closure device has two or more ends and a joint connected to the two or more ends via two or more arms;

[0144] wherein the closure device is configured relative to the closure device holder such that when the closure device is manipulated to withdraw from the distal end of the closure device holder during deployment of the medical device or closure device, the closure device releases its stress by bending the two or more arms out of the closure device holder, whereby the two or more ends perforate the inner wall of tissue surrounding the opening.

[0145] According to the present invention, a method for closing an opening in a tissue is also provided, the method comprising the following steps:

[0146] - providing a medical device according to the present invention;

[0147] - Use medical devices to close the opening.

[0148] In some embodiments according to the present invention, at least a portion of the closure device is made of a deformable shape memory alloy.

[0149] In some embodiments according to the present invention, at least a portion of the closure device is made of Nitinol.

[0150] In some embodiments according to the present invention, at least a portion of the closure device is made of a biocompatible and / or bioabsorbable material.

[0151] In some embodiments according to the present invention, the biocompatible and / or bioresorbable material is at least one material selected from the group consisting of titanium, titanium alloys, nitinol, stainless steel, polymeric materials, and ceramics.

[0152] In some embodiments according to the present invention, the closure device is curled into a closed form when in an unstressed state.

[0153] In some embodiments according to the present invention, the closure device is curled into a loop or ring or circular shape when in an unstressed state.

[0154] In some embodiments according to the present invention, after deployment of the medical device, the closure means has a cross-sectional dimension ranging from 10 microns to 1 centimeter, preferably from 40 microns to 200 microns, more preferably from 50 microns to 100 microns.

[0155] In some embodiments according to the present invention, the medical apparatus comprises a pushing device extending through a proximal end of the closure device holder for manipulating the closure device.

[0156] In some embodiments according to the present invention, the pushing device is a rod or a piston.

[0157] In some embodiments according to the present invention, the medical apparatus comprises a holding device extending through a proximal end of the closure device holder for manipulating the closure device, wherein the holding device is attached to the closure device.

[0158] In some embodiments according to the present invention, the retaining device is a string or a suture.

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

[0160] In some embodiments 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 to allow one or more ends of the closure device to exit the closure device holder when the closure device is deployed.

[0161] In some embodiments according to the present invention, the distal end of the closure device holder has two channels arranged opposite each other on a wall of the closure device holder.

[0162] Most state-of-the-art systems (e.g., using plugs, clips, or sutures) can only close relatively small arterial punctures up to 10 French (Fr) and are approved only for use at arterial access sites. Some systems are used off-label to close larger arterial or venous punctures.

[0163] The present invention advantageously provides an effective method and medical device for sealing large diameter openings up to 30 French (Fr), as well as larger openings in veins and other conduits passing through tissue.

[0164] The present invention allows for joining together tissue segments, or closing and / or sealing openings through tissue, such as very large caliber vascular perforations in the venous system, and in particular the femoral vein.

[0165] Such large vascular access and perforations are required for more complex interventional procedures such as transseptal mitral and tricuspid valve repair and prosthesis implantation.

[0166] The diameter of the femoral vein is approximately 8 mm or 24 French (Fr), or even larger, allowing the introduction of systems with similar diameters. Closing such large-caliber perforations of the vein using percutaneous systems utilizing plugs, sutures, or clips is very challenging. When closing such large-caliber perforations in a circular or longitudinal manner, the risk of vascular stenosis is high.

[0167] According to the present invention, a specific technique is advantageously used to stretch the perforation in a direction perpendicular to the long axis of the blood vessel and to suture the perforation closely along the stretching, thereby avoiding narrowing of the blood vessel lumen.

[0168] The present invention allows for closure of large caliber vessel perforations, particularly in veins, by stretching the perforation in a direction orthogonal to the long axis of the vessel and placing a single clip along the stretch, the clip closing the perforation along the line of stretch.

[0169] In some embodiments, the medical device may include a handle component and a tube set that is coupled to the handle component on one side (not shown) and the other side, and the retraction unit and closure component are deployed in the tissue opening sequentially or simultaneously. The handle component may also include any number of mechanisms (not shown) required to deploy the retractor and closure component. The retraction unit and closure component are deployed through a cannula that allows these units and components to be at least partially disposed in the opening or lumen of the blood vessel in a controlled manner, specifically along a guide structure (such as a guide wire or other track (not shown) that is typically placed in a blood vessel for performing interventional procedures).

[0170] The retraction unit optionally includes two retraction device holders, the distal ends of the two retraction device holders being configured to extend through the opening and be placed at opposite inner sides of the opening to be closed. The retraction device or its holder may have, for example, an engagement device mounted at its distal end. The engagement device may be arranged to engage the opposite ends of the opening and the opposite ends of the inner wall of the blood vessel, for example by contacting, pushing and / or abutting the opposite ends of the opening. Each engagement device is configured to move separately, retracting the opposite sides of the opening and stretching the opening so that the opposite sides of the opening approach between the retraction devices, so that the opening is straightened to have an extended long diameter and an orthogonally retracted short diameter.

[0171] The closure member optionally comprises one or more closure device holders having a distal end extending through the opening to be closed, the closure device holder having a closure device mounted thereon, for example, The closure device is arranged to engage the tissue wall when the closure device holder is withdrawn.

[0172] The closure device is preferably a pointed needle that penetrates the tissue wall surrounding the opening when the closure device holder is withdrawn. When the closure device engages the tissue wall, the engagement is detected as a firm resistance to further withdrawal.

[0173] The closure device is then deployed, further curved into a circular configuration, and draws the ends of the laterally retracted opening together in such a way that it closes the opening in a straight line.

[0174] The closure device optionally includes a plurality of circular needles of a size, orientation, and form such that when the closure device is moved outward from the interior of the opening, the closure device bends in an anchor-like manner according to a default memory shape of the closure device, perforating the tissue wall and also grasping tissue in close proximity to the wall, thereby pulling the tissue surrounding the perforation into close proximity with the closed opening so that the opening can be closed, and the surrounding tissue pulled in will further seal the tissue closure.

[0175] The closure device or devices may be detached from the closure device holder and delivery mechanism as desired and left in place.

[0176] When the tissue opening is closed in this manner, blood stasis can be achieved in the blood vessel by leaving the closing device attached to the tissue wall.The closing device can be composed of metal, plastic or bioabsorbable material, preferably with a memory material effect.

[0177] In some embodiments according to the present invention, a medical device comprising one or more retraction units is proposed for use in closing an opening, incision, puncture or other passage through tissue, a communication port with a blood vessel or other body cavity, and communicating with a blood vessel or other body cavity.

[0178] The retraction unit has, for example, two retraction device holders having distal ends for extending through the opening to be closed and having proximal ends for selectively providing manipulation.

[0179] The engaging means is captured in a retractor holder to be released by manipulation and placed under the opening to be closed. Manipulation of the retractor holder causes the opposite sides of the opening to retract, thereby changing the shape of the opening from a relatively round opening to a slit opening having an expanded transverse diameter (i.e., the longer diameter of the retracted opening) that is at least twice the length of the retracted longitudinal diameter (i.e., the shorter diameter) of the opening.

[0180] In some embodiments according to the present invention, a medical device is proposed for use in closing an opening in tissue, the medical device comprising a closing component having a closing device holder, the closing device holder having a distal end for extending through the opening to be closed and having a proximal end for selectively providing manipulation; and the medical device having a closing device that is grasped at the distal end of the closing device holder to be deployed, whereby the manipulation of the closing device holder and the deployment of the closing device close the opening.

[0181] In some embodiments according to the present invention, a medical device comprises a set of retraction units.

[0182] In some embodiments according to the present invention, the medical device comprises an indication to the user, which indicates the orientation or direction of the retraction unit of the medical device, eg the indication is implemented as a symbol, an arrow or the like.

[0183] In some embodiments according to the present invention, the medical apparatus further comprises a delivery device for delivering the closure device holder, the engagement device and the closure device into operative proximity with the opening, the delivery device being slidably connected to, for example, the closure device holder.

[0184] In some embodiments according to the present invention, the retraction device holder comprises an elongated tube made of metal or plastic capable of grasping the retraction device.

[0185] In some embodiments according to the present invention, the retraction units can be moved apart to retract the opening.

[0186] In some embodiments according to the present invention, the retraction device holder comprises an elongated tube made of metal, plastic, or other material capable of grasping the retraction device.

[0187] In some embodiments according to the present invention, the closure device holder has a transverse channel at the end of the elongated tube through which the closure device will exit the closure device holder, thereby avoiding contact between the closure device and a structure opposite the end of the elongated tube.

[0188] In some embodiments according to the invention, the closure member can be manipulated to evenly distribute the closure means along the line to be closed.

[0189] In some embodiments according to the present invention, the closure device is made of a perforated material (preferably a needle), wherein the perforated material is selected from a class of materials including metals, metal alloys, nitinol, plastics, preferably having memory effect properties, and having a permanent or bioresorbable protective coating and is bioresorbable.

[0190] In some embodiments, according to the present invention, a closure device has a predetermined cross-section, a proximal end, and two arms, each having a pointed end; both arms are curved portions of the closure device to expand between a first position and a second position when compressed and captured in the closure device holder. The closure device is substantially linear and can be moved in two directions along an axis within the closure device holder in a compressed or stressed state and can be released at the end of the closure device holder to return the arms to the expanded second position, wherein the arms have a curved shape forming a loop having two semicircles (hemi-circles or semi-circles).

[0191] In some embodiments according to the present invention, the closure device has a pre-set form that allows the closure device to be coupled together with the closure device holder.

[0192] In some embodiments according to the present invention, the present invention is directed to a method for closing an opening, incision, puncture or other conduit through tissue in a wall, communication with a blood vessel or other body lumen, specifically, but not exclusively, the wall of a blood vessel, wherein the blood vessel has a lumen that carries blood.

[0193] The method comprises the following steps:

[0194] a. retracting the opposite sides of the opening to be closed, thereby changing the shape of the opening from a relatively round opening to a more slit-like opening having a reduced diameter in the axial direction of the long axis of the vessel and an expanded orthogonal diameter to the long axis diameter of the vessel in preparation for connecting the expanded orthogonal sides of the opening;

[0195] b. One or more closure devices are inserted through the stoma and uniformly deployed into the lumen of the vessel, the closure devices being manipulated to engage the vessel wall around the stoma at the extended long sides of the stoma between the shoulders and to connect the two expanded orthogonal sides of the retracted stoma and close the stoma.

[0196] In some embodiments according to the present invention, the closing step comprises approximating the walls of the engaged opening by suturing, clamping or the like.

[0197] In some embodiments, the retraction device includes an engagement device coupled to the retraction device for releasably engaging tissue.

[0198] In some embodiments, the engagement device is configured to be foldable and / or to be at least partially contained or captured within the retraction device holder.

[0199] In some embodiments, at least two retraction devices and / or at least two engagement devices are releasably grasped within the retraction device holder, specifically so as to be at least partially released from the retraction device holder by manipulating the retraction device holder or the engagement device, specifically to be placed below the opening level of the opening to be closed.

[0200] In some embodiments, the retraction device holder and / or the retraction device and / or the coupling device are configured to retract the opposite side of the opening, specifically so that the opening changes its shape, for example from a fairly circular opening to a slit hole, preferably so that the expanded transverse diameter is at least twice the length of the retracted longitudinal diameter of the opening.

[0201] In some embodiments, the mechanism comprises or consists of shape memory properties.

[0202] In some embodiments, the closure device is at least partially contained within the closure device holder in a stressed state, specifically, the closure device is contained within the distal end of the closure device holder, specifically when the medical device is in an undeployed state; wherein the closure device preferably has two or more ends and a joint connected to the two or more ends, for example via two or more arms.

[0203] In some embodiments, the closure device is contained within the closure device holder such that when the closure device is manipulated to withdraw from the distal end of the closure device holder during use of the medical device, the closure device releases its stress, or a portion of its stress, by bending the two or more arms outward from the closure device holder. Thus, the two or more ends are arranged to perforate the inner wall of tissue surrounding the opening.

[0204] In some embodiments, at least a portion of the closure device, retraction device, retraction device retainer, and / or engagement device is made of a deformable shape memory alloy and / or has a self-expanding shape memory segment or wire body.

[0205] In some embodiments, at least a portion of the closure device, retraction device, retraction device retainer, and / or engagement device is made of Nitinol.

[0206] In some embodiments, at least a portion of the closure device, retraction device, retraction device retainer, and / or engagement device is made of a biocompatible and / or bioabsorbable material.

[0207] In some embodiments, the biocompatible and / or bioresorbable material is at least one material selected from the group consisting of titanium, titanium alloys, nitinol, stainless steel, polymeric materials, and ceramics.

[0208] In some embodiments, when in an unstressed state, the closure device or portion thereof curls into a closed form.

[0209] In some embodiments, when in an unstressed state, the closure device or portion thereof curls into a loop or ring or circular shape.

[0210] In some embodiments, the deployed closure device has a cross-sectional dimension ranging from 10 microns to 1 centimeter, preferably from 40 microns to 200 microns, more preferably from 50 microns to 100 microns.

[0211] In some embodiments, the medical device further comprises a pushing device, preferably extendable through a proximal end of the closure device holder, for operating the closure device.

[0212] In some embodiments, the urging device is a rod or a piston.

[0213] In some embodiments, the medical apparatus further comprises a retaining device extending through a proximal end of the closure device holder for manipulating the closure device, wherein the retaining device is coupled to the closure device.

[0214] In some embodiments, the retaining device is a string or suture.

[0215] In some embodiments, the closure device holder has one or more grooves on an inner wall of the closure device holder and / or one or more grooves on the pushing device for guiding the holding device along the longitudinal direction of the closure device holder.

[0216] In some embodiments, the distal end of the closure device holder has two or more channels in the wall of the closure device holder that allow one or more ends of the closure device to exit the closure device holder during manipulation of the medical device or when requested by the user.

[0217] In some embodiments of the medical apparatus according to the present invention, the distal end of the closure device holder has at least one channel or two channels, which are arranged opposite each other on a wall of the closure device holder.

[0218] In some embodiments, the retraction device holder comprises an elongated tube. The elongated tube comprises or consists of, for example, metal or plastic, and is preferably configured to grasp the retraction device.

[0219] In some embodiments, the method further comprises the following steps:

[0220] - introducing parts of the retraction unit into the opening;

[0221] - bringing opposite sides of the opening into contact with the retraction unit or components comprised therein;

[0222] - using the retraction unit or the components it comprises to retract the opposite sides of the opening and / or expand the opening; and

[0223] - releasing at least one closure device from a closure device holder and connecting opposite sides of the opening to each other using the closure device.

[0224] In some embodiments, the steps of retracting the opposite sides of the opening and / or expanding the opening cause the opening to change its shape to a slit opening or a slit-like opening or more like a slit opening, or to expand or increase the size or diameter of the opening in at least one or exactly one dimension.

[0225] In some embodiments, the retraction device is configured to retract the opening in a direction perpendicular to a longitudinal axis of the retraction unit and / or the retraction device holder.

[0226] In some embodiments, the retraction device is configured to retract the opening at an angle between 90° and 45° relative to the longitudinal axis of the retraction unit and / or the retraction device holder. The angle can be 90°, 85°, 80°, 75°, 70°, 65°, 60°, 55°, 50°, 45°, or any angle therebetween. Of course, in other embodiments, the angle can be 0° or an angle between 0° and 45°.

[0227] In some embodiments, the retraction device is configured to retract the aperture in a direction that is non-parallel to a longitudinal axis of the retraction unit and / or the retraction device holder.

[0228] In some embodiments, the retraction device or retraction unit does not have a motor or mechanism, for example, for rotating or moving an arm or other part, the arm or other part being used to retract the opposite sides of the opening around an axis or parallel to the axis, wherein the axis is the longitudinal axis of the retraction unit and / or retraction device holder.

[0229] In other embodiments, the retraction device or the retraction unit has a motor and / or a mechanism for acting on the retraction device and / or the retraction device holder.

[0230] In certain embodiments, the retraction device and the retraction device holder are arranged so as not to be movable independently of one another.

[0231] In some embodiments, the arms are portions, extensions, or protrusions of the retractor holder. For example, the retractor may have two distal tips, or it may terminate in a half-moon, C-shaped, or / and any other shape that is separated by a gap to offset the two portions and increase the gap or distance between the two portions. For example, the shape of the retractor holder may vary. Therefore, references to the two tips herein may be understood as referring to the arms described herein. Furthermore, references to "arms" herein also apply without reservation to the two free ends or tips of the aforementioned C-shaped or half-moon shape.

[0232] The term mechanism as used herein refers in particular to a mechanism consisting of movably arranged parts, such as a plunger, gears, and motor.

[0233] In some embodiments, the medical device includes a deployment device configured to be at least partially releasably received within a lumen of a retraction device holder. The deployment device may include a cylindrical body. The cylindrical body may be hollow, partially hollow, or solid. A distal portion of the deployment device may include a conical end segment. The tip, end, or distal-most portion of the end segment may include a spherical tip.

[0234] In some embodiments, the retraction device is placed at the distal tip, end or end section of the distal portion of the retraction device holder. The retraction device and the retraction device holder are preferably designed as one piece with each other and / or preferably connected to each other in a non-releasable manner or in a manner that does not need to be released when using the present invention.

[0235] In some embodiments, the retraction device comprises (or consists of) a first arm and a second arm.Preferably, the first arm and the second arm are positioned or provided parallel to each other, at least when the retraction unit is placed into the opening.

[0236] In some embodiments, the retraction device includes a first arm and a second arm (or consists of a first arm and a second arm, which are arranged on the surface of the deployment device or in contact with the surface of the deployment device when (or during) the deployment device is positioned at the opening, and after the deployment device is pulled out of the retraction device holder, the first arm and the second arm expand to a retracted state of the opening.

[0237] In some embodiments, the retraction device includes (or consists of) a first arm and a second arm, which are releasably attached to or in contact with a surface of the deployment device when the retraction device is advanced into or into the opening, and which unfold to assume a retracted state of the opening after the deployment device is pulled out of the retraction device holder.

[0238] In some embodiments, the retraction device includes a first arm and a second arm (or consists of them), which are arranged on the surface of the deployment device when the deployment device is placed into the opening, and after the deployment device is pulled out of the retraction device holder, it is passively expanded to the retracted state of the opening without the need for a mechanism.

[0239] In some embodiments, when the retraction unit is placed into the opening, the retraction device holder or its inner cavity exhibits, presents or displays a first shape or a first cross-section, preferably a circular cross-section having a cross-sectional diameter, and a second shape or a second cross-section after the deployment device is partially or completely pulled out of the retraction device holder, preferably an elliptical cross-section having a major axis length, preferably greater than the cross-sectional diameter.

[0240] In some embodiments, when the retraction unit is placed into the opening, the retraction device holder or its inner cavity exhibits, presents or displays a first shape or a first cross-section, preferably a circular cross-section with a cross-sectional diameter, and a second shape or a second cross-section after the deployment device is partially or completely pulled out of the retraction device holder, preferably an elliptical cross-section with a major axis length, preferably greater than the cross-sectional diameter, preferably an elliptical cross-section with two axes of symmetry, a major axis and a minor axis.

[0241] In some embodiments, the shape or cross section of the closure device holder primarily presents a second shape or second cross section, corresponding thereto and / or having an elliptical cross section, preferably having a major axis length slightly less than this length. In some embodiments, the retraction device holder or a portion thereof has sufficient flexibility and / or elasticity to enable the closure device holder to adapt to the shape or cross section of the retraction device holder when it is inserted / introduced into the retraction device holder (and preferably (by it being introduced alone, i.e. without any additional assistance)). For example, if the closure device holder or a portion thereof has an elliptical cross section, in these embodiments, the retraction device holder or its inner lumen also presents an elliptical cross section. In addition, if a deployment device with a circular cross section is inserted into the inner lumen of the retraction device holder, the inner lumen can present a circular cross section.

[0242] Thus, in some embodiments, the retraction device holder or the portion defining its interior lumen may be made of a flexible or resilient material.

[0243] Additionally, in some embodiments, the retraction device holder or the portion defining / defining (bounding) its interior lumen may be made of a material that does not have a memory effect.

[0244] Thus, in some embodiments, the retraction device holder, or the portion defining its interior lumen, may be made of a non-flexible or non-elastic material.

[0245] In some embodiments, the medical device includes one or more rods or other protrusions positioned between or adjacent to the openings of the closure device holder to facilitate withdrawal of the closure device. The rods are positioned to protrude beyond the open area of at least one of the openings. The rods may be integral to the closure device holder and may function to prevent damage to the opposing vessel wall or tissue when the closure device is released from the closure device holder.

[0246] In some embodiments, the medical device includes a connector coupled to or integral to the retraction device holder, providing an opening for advancing the deployment device and / or closure device holder into the interior lumen of the retraction device holder.

[0247] In some embodiments, the interior lumen of the connector, its cross-section, or the open area of its opening may include a segment that (at least partially) defines a circle and a segment that (at least partially) defines an ellipse.

[0248] In some embodiments, the connector may include a sealing ring, membrane, diaphragm, etc. that acts as a seal by conforming to or abutting against an outer surface of a device inserted through the connector into the interior lumen of the retraction device holder.

[0249] In some embodiments, a seal, membrane, diaphragm, etc., may include slits through its material to allow the material to deflect or diverge in order to receive the device and reclose the opening once the device is removed from the retraction device holder.

[0250] Therefore, in some embodiments, the shape of the connector's internal cavity or its cross-section or opening area is neither solely circular nor solely elliptical.

[0251] In some embodiments, the closure device holder is preferably at least partially releasably received in the retraction device holder, preferably translatable in a longitudinal direction of the closure device holder.

[0252] In some embodiments, a method for closing an opening in tissue comprises the steps of:

[0253] - 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 positioned on or attached to a remote portion of the retraction device holder;

[0254] - inserting the deployment device into the inner cavity of the retraction device holder;

[0255] - pushing the deployment device and retraction device holder, including the retraction device, forward toward the opening until the first arm and the second arm are positioned within the opening;

[0256] - pulling the deployment device back from the lumen of the retraction device holder;

[0257] - inserting a closure device holder having a closure device into the inner cavity of the retraction device holder, wherein the inner cavity is optionally generally elliptical or oval, so that the distal opening or opening of the closure device holder, for withdrawing the closure device from the closure device holder, is positioned in the opening;

[0258] - Pushing out, bringing out or releasing the closure device to close the opening;

[0259] - Optionally closing the opening by a closure device.

[0260] In some embodiments, a number of arms are provided as retraction units or parts thereof. In some embodiments, some or all of the arms are provided in a line or in a common plane, or intersect with a common plane.

[0261] In some embodiments, the tip of the retraction unit is formed by the tips of the arms being arranged not to be offset from each other laterally, preferably in the absence of a state when closing the opening.

[0262] In some embodiments, the lengths of the arms are different from one another. Thus, the arms may be provided with two or more different lengths, or some arms may be removed from the retraction unit, common sheath, or cannula thereof to a greater length than other arms.

[0263] Thus, in some embodiments, the retraction unit 100 may include or consist of several arms. Some of the arms may have different lengths or the arms may advance from the interior of the retraction unit 100 to the exterior thereof to different degrees.

[0264] In certain embodiments, some of the arms of the retraction unit may be arranged to be advanced into an advanced position and to be retracted again from the advanced position without bending or deflecting to the side.

[0265] In some embodiments, the arms may be straight or longitudinal components that cannot bend during use or are always parallel to each other (or both).

[0266] In some embodiments, the arms can assume no configuration other than the unadvanced configuration (eg, due to shape memory properties).

[0267] The arms can be arranged to be able to be removed from the sleeve or interior of the medical device only when they are moved together.Thus, the arms can be connected to each other in such a way that they can only be advanced as a whole group.

[0268] In some embodiments, a protector is provided that may include or consist of electrical wires.

[0269] The protector may be connected to the arms, the protector being arranged to slide out of the sleeve of the medical device or relative to other parts of the medical device together with or only with the respective arm.

[0270] In some embodiments, one arm is connected to the upper surface of one protector and the other protector is connected to the lower surface thereof.

[0271] In some embodiments, the protector is arranged to deploy in a direction which is preferably perpendicular (or also perpendicular) to the longitudinal axis of the retraction unit or the arms.

[0272] The protector may be arranged to expand in a direction which is preferably perpendicular (or also perpendicular) to the direction of maximum extension of the retraction unit or the direction of the arms in the width of the retraction unit or its sleeve.

[0273] In some embodiments, the width of the sleeve, or the width or depth of the retraction unit, is preferably such that the cross section of the sleeve or the retraction unit is not circular, but flat, rectangular, oval or the like.

[0274] In some embodiments, the closure device comprises or consists of two arms. The two arms may be made from the same common integral material or attached one to the other in an attachment area. The two arms may be glued, welded or attached to each other in any other manner.

[0275] In some embodiments, the closure device is asymmetrical in shape, preferably without states.

[0276] In some embodiments, the attachment area is oblique to the centerline of the closure device.

[0277] For example, the attachment area may be inclined at an angle between 20° and 70°, preferably between 30° and 60°, to a line perpendicular to the line of maximum width or perpendicular to the tip of the connecting arm.

[0278] In some embodiments, the attachment area includes a port 611. The port 611 may have a closed circumference, or it may be open to the circumference at an extension thereof. The extension may be narrower than the radius of the port itself. Thus, the extension may transform the overall shape of the port into a keyhole-like shape. The extension may be a bottleneck in a plane where the main area of the port is located.

[0279] The wires comprising the arms of the closure device preferably include or consist of flat wires. Unlike round wires, flat wires lack a circular cross-section. Their cross-sections are elliptical, rectangular, or otherwise deviate from a circular shape. Flat wires provide a higher gripping force without exceeding the irreversible strain threshold of, for example, nitinol. Furthermore, the closure device appears to be able to secure a vessel wall with a significant amount of perivascular tissue and gather it to achieve hemostasis and complete closure.

[0280] In some embodiments of the present invention, a medical device for closing an opening includes the features disclosed herein, which may be used in any combination unless deemed technically infeasible by a person skilled in the art. These and other more detailed and specific objects of the present invention and an understanding of the various embodiments will become apparent by considering the following detailed description of exemplary embodiments with reference to the drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0281] Figure 1 A to Figure 1 D is a schematic side view of an embodiment of a retraction unit of a medical device according to the present invention;

[0282] Figure 2 A to Figure 2 F is a side view of an alternative embodiment of the retraction unit;

[0283] Figure 3 A to Figure 3 D is a schematic partial cutaway view of a retraction unit deployed within an opening;

[0284] Figure 4 A to Figure 4 D is a side view of an alternative embodiment of a retraction unit;

[0285] Figure 5 A to Figure 5 D is a schematic, partially cut-away side view of a retraction unit deployed within an opening;

[0286] Figure 6 A and Figure 6 B is a front view of a closure device of a medical device according to an embodiment of the present invention, the closure device being in a preferred expanded circular form and a compressed straight form of the needle;

[0287] Figure 7 A to Figure 7 F is Figure 6 a side view of the closure device shown deployed in an opening, penetrating tissue and engaging the free edges of the opening;

[0288] Figure 8 is a schematic side view in the longitudinal direction of a closure member comprising a straight folded (understood as compressed or undeployed) closure device captured in a closure device holder;

[0289] Figure 9 is a schematic perspective view of a closure member comprising a straight, folded closure device captured in a closure device holder;

[0290] Figure 10 is a schematic, partially cut-away longitudinal cross-sectional view of a closure member deployed within an opening in a blood vessel;

[0291] Figure 11 is a schematic, partially cut-away longitudinal cross-sectional view of a closure member advanced into a stoma of a blood vessel;

[0292] Figure 12 A to Figure 12 E is Figure 10 The closing parts and Figure 6 a schematic partial cutaway longitudinal cross-sectional view of a closure device in FIG, wherein the closure device is deployed in an opening, penetrates tissue, and connects the free edges of the opening;

[0293] Figure 13 A to Figure 13 H is Figure 10 Alternative closure components and Figure 6 a schematic partial cutaway longitudinal cross-sectional view of a closure device in FIG, wherein the closure device is deployed in an opening, penetrates tissue, and connects the free edges of the opening;

[0294] Figure 14is a schematic partially cutaway perspective view of two retraction units advanced into an opening;

[0295] Figure 15 is a schematic partially cutaway perspective view of two retraction units deployed within an opening, Figure 4 The two retraction devices are advanced and deployed within the blood vessel;

[0296] Figure 16 is a schematic partially cutaway perspective view of two retraction units deployed within an opening, Figure 4 The two retraction devices are advanced and deployed within the blood vessel, and the stoma is retracted;

[0297] Figure 17 is a schematic partially cutaway perspective view of two retraction units deployed within an opening, Figure 4 The two retraction devices are advanced and deployed within the blood vessel, the two retraction devices are retracted until a stop is felt, and the stoma is expanded until the stoma becomes a straight slit and a stop can be felt;

[0298] Figure 18 is a schematic partially cutaway perspective view of two retraction devices and two closing devices deployed simultaneously or sequentially within an opening;

[0299] Figure 19 is a schematic partially cutaway perspective view of two retraction devices and two closing devices deployed in an opening, the opening being retracted and the long edges of the opening being formed by Figure 6 The partially deployed closure device is shown approaching;

[0300] Figure 20 yes Figure 6 A schematic partially cutaway perspective view of two retraction devices and two closing devices in FIG, wherein the two closing devices are fully deployed and connected to the long edges of the opening, and the retraction units are retracted one after another;

[0301] Figure 21 is released Figure 6 A schematic perspective view of two closing devices in FIG, wherein the closing devices close the opening with transverse lines;

[0302] Figure 22 is a schematic, partially cutaway perspective view of two retraction devices and a closure member being simultaneously advanced into an opening in a blood vessel;

[0303] Figure 23 is a schematic, partially cutaway perspective view of two retraction devices and a closure member deployed within an opening in a blood vessel, the opening being retracted in a direction orthogonal to the long axis of the blood vessel;

[0304] Figure 24is a schematic partially cutaway perspective view of two retraction devices and a closure member further advanced into an opening in a blood vessel, the opening being retracted in a direction orthogonal to the long axis of the blood vessel, and the long edges of the opening being formed by Figure 6 Approach and penetration of the partially deployed closure device;

[0305] Figure 25 is a schematic partially cutaway perspective view of a blood vessel having a closure device closing the opening;

[0306] Figure 26 A to Figure 26 G is a schematic partially cutaway perspective view of the seven steps (a to g) of the entire procedure for closing a vascular stoma;

[0307] Figure 27 An opening in a patient's blood vessel and its closure with a transverse surgical suture are shown;

[0308] Figure 28 An opening in a patient's blood vessel and its closure using a crossover surgical procedure are shown;

[0309] Figure 29 An opening in a patient's blood vessel and its closure using longitudinal surgery are shown;

[0310] Figure 30 A perspective view of a closure device in an embodiment is shown;

[0311] Figure 30A Shown in front view Figure 30 Closure device;

[0312] Figure 31 A closure device in another embodiment is shown in a front view;

[0313] Figure 31A Shown in a three-dimensional diagram Figure 31 Closure device;

[0314] Figure 32 A closure device in yet another embodiment is shown in a front view;

[0315] Figure 32A Shown in a three-dimensional diagram Figure 32 Closure device;

[0316] Figure 33 A perspective view shows a portion of a medical device according to an embodiment of the present invention;

[0317] Figure 33A Basically shown from the front Figure 33 medical equipment;

[0318] Figure 34 A portion of another embodiment of a medical device is shown in perspective view;

[0319] Figure 35 A portion of another embodiment of a medical device is shown from the side;

[0320] Figure 36 showing a highly simplified view of the front surface of a medical device;

[0321] Figures 37A to 37F Two additional exemplary embodiments of closure devices used in embodiments of the present invention are shown in different views;

[0322] Figure 38 A handle component of a portion of an embodiment of a medical device according to the present invention is shown, with a metal guide wire advanced into a blood vessel;

[0323] Figure 39 An embodiment of a retraction device is shown, wherein the retraction device is activated by a handle member;

[0324] Figure 40 Three closure device holders (optionally in parallel) are shown being pushed into the opening via the handle member;

[0325] Figure 40A Shown for Figure 40 a transfer bracket for three parallel closure device holders;

[0326] Figure 40B Show Figure 40A The delivery stent is in an expanded state;

[0327] Figure 40C A sleeve with a guide groove is shown as an insert or part of a handle component;

[0328] Figure 41 The closure device is shown to be composed of three closure device holders and is pushed forward by the mechanism of the handle member;

[0329] Figure 42 Show Figure 41 The three closure device retainers are pulled back by the mechanism of the handle member;

[0330] Figure 43 showing the release of the retraction device from the access site by the mechanism of the handle member; and

[0331] Figure 44 showing a mechanism for completely removing or removing the retraction device and handle component of the medical device from the access site;

[0332] Figure 45 shows the design of an exemplary embodiment of a retraction device and an engagement device;

[0333] Figures 46A to 46Eis a schematic diagram of an alternative embodiment of a retraction unit of a medical device according to the present invention;

[0334] Figures 47A to 47C Shown as Figure 46C Additional embodiments of closure device holders for retraction devices are shown;

[0335] Figure 48A and Figure 48B A connector is shown having openings for a retraction device holder and a closure device holder;

[0336] Figure 49 A perspective view showing part of a medical device according to another embodiment of the present invention;

[0337] Figure 49A Shown essentially from the side Figure 49 medical equipment;

[0338] Figure 50 A perspective view showing a closure device in an embodiment;

[0339] Figure 50A Show Figure 50 Another perspective view of the closure device;

[0340] Figure 51 The closure device according to the invention is shown in a first state;

[0341] Figure 51A Show Figure 51 The closure device is in a second state; and

[0342] Figure 51B Show Figure 51 The arms of the closure device are separated from each other.

[0343] Main component marking instructions

[0344] 100: Retraction unit 101: Retraction device

[0345] 101a: Arm 101b: Arm

[0346] 101d: Protector 102: Retraction device holder

[0347] 103: Deployment Device 108: Arrow

[0348] 110: distal tip / far end of the retraction device holder 111: proximal end

[0349] 112: Remote 115: Guidewire Lumen

[0350] 117: casing 121: foot

[0351] 123: Foot 125: Welding part

[0352] 127: Middle opening 131: Opening

[0353] 133: Opening 135: First arm

[0354] 137: Second arm 139: Groove

[0355] 141: Contraction 202: Suture / holding device

[0356] 203: Piston 204: Groove

[0357] 207: Groove 301: Blood vessels / vascular walls / tissue

[0358] 302: (blood vessel) opening / slit opening / opening 303: outside the patient's body

[0359] 304: Patient's skin 305: Patient's body

[0360] 410: Engaging device 420: Bend / step

[0361] 500: Connector / Hemostatic Valve 501: Opening / Sealing Lip / Slit

[0362] 502: Opening / Sealing Lip / Slit 503: Irrigation Catheter / Sheath Irrigation Catheter

[0363] 600: Closure device 602: Proximal end / joint / groove

[0364] 603: distal end / pointed end / tip of closure device / closed 604: arm

[0365] End of the device

[0366] 604a: Arm 604b: Arm

[0367] 605: Curled or curved section 607: Non-curled or straight section

[0368] 609: Attachment area 611: Through hole

[0369] 611a: Extension 708: Anchor form of anchor / closure device

[0370] 709: Tip 603 penetrates the tissue wall 722: Perforation of 603

[0371] 800: Closing part 801: Longitudinal direction arrow / arrow indicating the direction of the support or closing device holder

[0372] 802: Closure device holder 803: Channel / lateral channel

[0373] 804: Distal / closure device holder end 805: Proximal / closure device holder end

[0374] 806: Transfer bracket 807: Buffer

[0375] 808: Push tube 809: Rod (of closure device holder)

[0376] 810: Groove (between rods) 900: Handle part

[0377] 902: First slider 904: Second slider

[0378] 906: switch 908: opening of the handle part

[0379] 910: Multi-cavity extrusion port or opening 912: Knob

[0380] 914: sleeve 916: guide groove

[0381] 916a: first slot section 916b: second slot section

[0382] 916c: Turning point 1000: Guide wire

[0383] 1006: Blood vessel lumen 1411: Opening wall / edge

[0384] 1420: Arrow 1421: Move up

[0385] 1422: Angle 1722: Protractor

[0386] 2204: Wall / Opening Wall / Long Side 2600: Suture

[0387] 2700: Arrow B: Width

[0388] L: longitudinal axis D R : Cross-sectional diameter

[0389] D N : Spindle length W: Width DETAILED DESCRIPTION

[0390] Specific embodiments of the present invention relate to a vessel closing apparatus and method for closing an opening in tissue, such as a vessel closing device including a tissue retraction unit and an opening closing component.

[0391] Tissue Retraction:

[0392] In one aspect of the present invention, a retraction unit is provided to retract two opposing portions of a tissue opening. After two arms, sides, etc. are deployed at opposing sides of the opening for closure, the distance between the arms, sides, etc. is increased to retract the opposing sides, thereby changing the shape of the tissue opening (opening) into a slit in which the two long straight sides of the opening are brought close together in preparation for closure.

[0393] Those skilled in the art will appreciate that the vessel closure described herein follows the principles of surgical vessel closure techniques to prevent narrowing or stenosis of the vessel being treated. The retraction device provides for the opening in the tissue to become a transverse slit orthogonal to the long axis of the vessel, comparable to open surgical transverse sutures. As in open surgical cross-stitching or longitudinal sutures, circular retraction of the opening is prevented to avoid narrowing of the vessel being treated, see Figure 27 .

[0394] Opening closure:

[0395] Another aspect of the present invention relates to a closure member for closing a tissue opening prepared using a retractor unit. It will be appreciated that the retractor unit and closure member may be used for general tissue repair and not just vascular repair. It will be understood that in the following description, the closure device of the medical device may 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 description that the closure device preferably has the shape of a needle in the form of a loop or circle formed from a deformable shape memory alloy (e.g., nitinol). As a general overview, the closure device of the present invention undergoes two deformed positions: a first position in a compressed, straight configuration in which the closure device is captured in a closure device holder and deployed in the opening; and a second, expanded, circular configuration in which the closure device approximates the ends of the opening and closes the perforation in the tissue.

[0396] After the opening in the tissue is prepared by the retraction device to form a slit, the two long sides of the slit are connected by the closing device to close the tissue opening.

[0397] Figure 11 is a side view of a retraction unit 100 of the present invention. The retraction unit 100 optionally includes a longitudinally hollow retraction device holder 102 having a distal tip 110. A retraction device 101 is folded and captured in the tubular retraction device holder 102. The retraction device 101 has one or more proximal ends 111 and two distal ends 112. The retraction device 101 is optionally made of a material having a memory effect and is capable of expanding the two distal ends 112 apart like a spring. The retraction device 101 can be formed of a shape memory alloy (e.g., Nitinol) that is formed into a triangular shape in the expansion phase and can be compressed to be captured in the retraction device holder 102. As the retraction device holder 102 retracts along arrow 108, the retraction device 101 is gradually released, and the distal ends 112 gradually expand due to the memory effect of the retraction device 101.

[0398] Figure 2 Yes Figure 1 A side view of an alternative embodiment of a retraction unit 100 is shown. The retraction unit 100 has a longitudinally hollow retraction device holder 102 having a distal tip 110. The retraction device 101 is folded and captured in the tubular retraction device holder 102. In this embodiment, the retraction device holder 102 has a groove 207 in cross section, in which the arms of the retraction device 101 are captured and guided when the retraction device 101 is moved in the longitudinal direction, specifically in the distal direction of the retraction device holder 102. The retraction device 101 is pushed toward the distal end 110 of the retraction device holder 102, for example, by a piston 203, which is optionally captured in the retraction device holder 102. The retraction device 101 is surrounded by a suture 202, which is optionally tethered to the retraction device 101. The piston 203 has a groove 204 in cross section, and the suture 202 is caught in the groove 204. Figure 2 C direction Figure 2 When E pushes the piston 203, the retraction device 101 is gradually released ( Figure 2 C to Figure 2 F), and due to the memory effect of the retraction device 101, the distal end 112 gradually expands. During the period when the distal end 110 of the retraction device holder 102 is pushed longitudinally toward or pulled away from the distal end 110 of the retraction device holder 102 by the piston 203, the retraction device 101 remains connected to the piston 203 by the tethering suture 202 or similar active component. Once the retraction device 101 is fully released, the retraction device holder 102 including the piston 203 can be removed, leaving the retraction device 101 still tethered by the suture 202. Later, the retraction device 101 can be removed from its position (opening) by pulling on both ends of the suture 202.

[0399] Figure 3 is a schematic partial cutaway view of the retraction unit 100 deployed within a blood vessel stoma 302.

[0400] The retraction unit 100 is developed so that it can be deployed through a wound in a patient through a cannula characterized by extending from outside the patient's body so that it is located remotely through the opening 302 to be closed and within the lumen of a blood vessel 301 .

[0401] The dimensions of the retraction unit 100 and the retraction device 101 vary depending on the size of the opening 302 and the size of the blood vessel 301 or other body organ to be closed within the patient's body, as well as the material composition of the unit and the device.

[0402] The retraction unit 100 having the retraction device holder 102 and grasping the retraction device 101 is inserted into the opening 302 of the blood vessel 301. Once the distal end 110 of the retraction device 101 is deployed below the opening 302 in the blood vessel wall, the retraction device holder 102 is gradually retracted in a direction away from the blood vessel opening 302 (from the distal end 110 to the distal end 110). Figure 3 A to Figure 3 D), and the retraction device 101 is released. Due to the memory property of the retraction device 101, the opening 302 gradually moves from the longitudinal axis of the blood vessel to the longitudinal axis of the blood vessel. Figure 3 B expands to Figure 3 D and the blood vessel wall 301 becomes Figure 3 Slit opening 302 in D.

[0403] Figure 4 Yes Figure 1 A side view of an alternative embodiment of the retraction unit 100 is shown. The retraction unit 100 has a longitudinal hollow retraction device holder 102 having a distal tip 110. The retraction device 101 is folded and captured in the tubular retraction device holder 102. The retraction device 101 has a proximal end 111 and two distal ends 112, each of which has an optional engagement device 410. The engagement device 410 is preferably a loop-like element, preferably a wire loop, which is initially formed in an expanded state and can be folded and captured in the retraction device holder 102. The retraction device 101 is optionally made of a material with a memory effect, such as a memory alloy (e.g., Nitinol), and is capable of expanding the two distal ends 112 and unfolding the wire loop 410. When the retraction device holder 102 is retracted along the arrow (from Figure 4 B to Figure 4 D), the retraction device 101 is gradually released, and due to the memory effect of the retraction device 101, the two arms 112 of the retraction device 101 expand and the distal engagement member 410 deploys.

[0404] Figure 5is a schematic, partially cut-away side view of the retraction unit 100 deployed within an opening 302 of a blood vessel 301 .

[0405] The retraction unit 100 is developed so that it can be deployed through a wound in a patient through a cannula characterized by extending from outside the patient's body so that it is located remotely through the opening 302 to be closed and within the lumen of a blood vessel 301 .

[0406] The dimensions of the retraction unit 100 and the retraction device 101 vary depending on the size of the opening 302 and the size of the blood vessel 301 or other body organ to be closed within the patient's body, as well as the material composition of the unit and the device.

[0407] The retraction unit 100, which has a retraction device holder 102 and grasps a retraction device 101, is inserted into the opening 302 of the blood vessel 301. The retraction device 101 has a proximal end 111 and two distal ends 112, each of which has an engagement member 410. The engagement member 410 is preferably a wire loop that can be folded and grasped in the retraction device holder 102. Once the distal end 110 of the retraction device holder 102 is deployed under the opening 302 in the blood vessel wall, the retraction device holder 102 is gradually retracted in a direction away from the blood vessel opening 302 (from the distal end 111 to the distal end 112). Figure 5 A to Figure 5 B), thereby releasing the engaging means 410 ( Figure 5 D) The engaging device 410 is deployed below the blood vessel opening 302 and engages the inner wall of the blood vessel around the opening. Figure 5 B is further released to Figure 5 C, due to the memory property of the engagement means 410, the opening 302 is gradually expanded (from Figure 5 B to Figure 5 D) and becomes a slit opening 302 in the vessel wall 301 ( Figure 5 D) When the blood vessel opening 302 is in a slit shape, the deployed engagement device 410 prevents the engagement device 410 from retracting from the blood vessel opening 302 .

[0408] Figure 6 600. The closure device 600 has a proximal end 602 and first and second arms 604, each optionally having a pointed distal end 603. The two arms 604 are curved portions of the closure device 600.

[0409] The closure device 600 has an expanded substantially closed position ( Figure 6A), wherein the two arms 604 each form a hemi-circle (semi-circle) in one or substantially one plane, thereby allowing the two arms 604 to cross each other; and a compressed substantially closed position ( Figure 6 B), wherein the two arms 604 are substantially linear, thereby allowing the closure device 600 to be grasped in the retraction device holder 102 ( Figure 5 ) or in the closing part 800.

[0410] The closure device 600 can be made from a variety of default shape memory materials, where the material selection depends on the specific needs.

[0411] The closure device 600 can be formed from any biocompatible material, such as titanium (and titanium alloys), nitinol, stainless steel, polymeric materials (synthetic and / or natural), ceramics, and / or bioresorbable materials, for example, using galvanic corrosion. The decomposition rate can be adjusted by the composition so that no visible bubbles are formed. The closure device 600 is preferably made of a shape memory alloy (e.g., nitinol) and is capable of forming a ring-like structure. The size of the closure device 600 depends on the material composition of the needle and the desired size of use. Depending on the application, the closure device 600 can have a size and cross-sectional dimensions ranging from 10 microns to 10 centimeters. The size will depend on the target closure size and the size of the opening 302 to be closed.

[0412] Preferably, the expanded loop closure device 600 ( Figure 6 A) can be elastically compressed into its compressed state ( Figure 6 B), for example, by using Figure 8 A closure member 800 is shown to constrain it.

[0413] The closure device 600 can be opened from a collapsed state ( Figure 6 B) Deploy to Figure 6 A. When in the partially expanded state, the closure device 600 can be used like an anchor to locate its position by withdrawing the partially expanded closure device 600 in the opening 302 to be closed until the hook-shaped closure device 600 passes through the wall, and further withdrawal can be detected by increasing resistance to further withdrawal (e.g., Figure 13 F).

[0414] The closure device 600 has a pointed end 603 that will engage one side of the perforated wall surrounding the opening 302, penetrate the wall of the perforated wall 302, and an anchor-like curved arm 604 that will approach the perforated tissue wall, such as Figure 7 The expanded closure device 600 represents Figure 6 The groove 602 of the proximal end 602 of the closure device 600 in B (see Figure 6A) Allows locking of the closure device 600 to the closure member 800, as follows Figure 13 As shown in .

[0415] Figure 7 Yes Figure 6 A side view of closure device 600 is shown deployed in opening 302 , penetrating tissue 301 , and engaging the free edges of opening 302 .

[0416] Figure 7 Show Figure 6 Subsequent deployment of the closure device 600 in the opening 302 to be closed.

[0417] exist Figure 7 In A, the closing device 600 (such as Figure 6 ) is in a compressed straight configuration and is advanced in an opening 302 in tissue 301.

[0418] exist Figure 7 In B, the closure device 600 is partially deployed and the tip 603 of the closure device is bent due to the memory material effect.

[0419] exist Figure 7 C, as the closure device 600 is further deployed, the end of the closure device 603 further bends into an anchor form 708, wherein the pointed end of the closure device 603 engages a side of the tissue opening 301 and penetrates (see 709) the wall 301.

[0420] The closure device 600 is then withdrawn and the pointed end 722 of the anchor-shaped closure device 708 perforates the tissue 301. Further deployment of the closure device 600 will cause each of the two curved arms of the closure device 600 to complete a semicircle, thereby approximating and closing the opening 302.

[0421] However, it should be understood that deployment of the closure device 600 optionally requires the closure device holder 802, as described later. Figures 8 to 12 It will be appreciated that more closure devices 600 may be utilized depending upon the embodiment of the closure device 600 and its organization.

[0422] Figure 8 8 is a schematic cutaway side view of a closure member 800 in longitudinal direction 801, consisting of a longitudinal hollow closure device holder 802 with a distal end 804. The closure device holder 802 houses a straight compressed closure device 600. The closure device holder 802 optionally has a transverse channel 803 for deploying the closure device 600.

[0423] Figure 9 Yes Figure 8A schematic cutaway perspective side view of a closure device holder 802 indicated by arrow 801 is shown, housing a straight, folded closure device 600. The closure device holder 802 optionally has a transverse channel 803 for deploying the closure device 600. The channel 803 allows the closure device 600 to be deployed in the form of an anchor 708 ( Figure 12 C) exit the closure device holder 802 in a curved manner, such as Figure 12 B to Figure 12 D, but prevents the closure device 600 from engaging structures and tissues (such as opposing blood vessel walls) that may be positioned relative to the end 804 of the closure device holder 802.

[0424] Figure 10 is blood vessel 301 and Figure 8 and Figure 9 801, which houses the straight, folded closure device 600 and is advanced through the opening 302 in the vessel wall 301 into the vessel lumen 1006. A channel 803 in the distal closure device holder 802 allows the closure device 600 to be positioned in the form of an anchor 708 ( Figure 12 C) as Figure 12 B to Figure 12 The curved pattern shown in D exits the closure device holder 102, thereby preventing the closure device from engaging the opposing vessel wall 301.

[0425] Figure 11 is blood vessel 301 and Figure 8 、 Figure 9 and Figure 10 Schematic partial cutaway perspective view of a longitudinal cross-section of a closure device holder 802 indicated by arrow 801, which houses a straight compressed closure device 600 and is deployed into the vessel lumen 1006 through the opening 302 in the vessel wall 301. A channel 803 in the distal closure device holder 802 allows the closure device 600 to be deployed, for example, with an anchor 708 ( Figure 12 C) in the form of Figure 12 B to Figure 12 The curved pattern shown in D exits the closure device holder 102, thereby preventing the closure device from engaging the opposing vessel wall 301.

[0426] Figure 12 yes Figure 8 and Figure 9 A schematic partially cutaway longitudinal sectional view of the closure device holder 802 indicated by arrow 801, which is shown in FIG. Figure 12 A to Figure 12 The sequence of E is shown in Figure 8 The closure device holder 802 is deployed in Figure 12 In the opening in A.

[0427] exist Figure 12 In B, the closure device 600 is pushed outward in the direction of the end 804 of the closure device holder 802 and the tip of the closure device 603 bends and exits the closure device holder 802 in the channel 803 .

[0428] exist Figure 12 In C, the closure device 600 is pushed further in the direction of the end 804 of the closure device holder 802, thereby exiting the closure device holder 802 further through the passage 803 and optionally forming the anchor 708. The tip 603 of the closure device 600 engages the vessel wall 301.

[0429] exist Figure 12 In D, the closure device holder 802 is further withdrawn from the opening 302. The pointed end of the anchor 708 penetrates 722 the vessel wall 301. Further withdrawal can be detected by a firm resistance to further withdrawal. The closure device holder 802 is then further retracted from the vessel opening 302, and the closure device 600 is released. The arms 604 of the closure device 600 bend inward, thereby drawing the ends of the opening 302 together to close the opening 302 and form a closure as shown in FIG. Figure 6 The ring structure shown.

[0430] Figure 13 is a schematic, partially cut-away, longitudinal cross-sectional view of an alternative closure member 800 deployed in an opening 302 in the wall of a blood vessel 301 . Figure 13 exist Figure 13 C to Figure 13 The sequence H shows the deployment of the closure device 600 and the closing of the aperture 302 by the closure device 600. In this embodiment, the closure member 800 captures the piston 203.

[0431] Figure 13 A shows a cross section of a piston 203 having a groove 204 in which a holding means 202, preferably a suture, is guided. The holding means 202 is tethered to the closing device 600 in order to connect the piston 203 and the closing device 600 together.

[0432] Figure 13 B shows Figure 8 The cross section of the closure device holder 802 is shown, which has a groove 207 in which the arms of the closure device 600 are caught and guided when the closure device 600 is moved in the longitudinal direction, specifically in the direction of the distal end 804 of the closure device holder 802. The closure device 600 is pushed by the piston 203 toward the end 804 of the closure device holder 802, as shown in FIG. Figure 13C to Figure 13 The sequence of H is shown in FIG.

[0433] exist Figure 13 In C, the end of the closure member 800 is deployed in the opening 302 in the wall of the blood vessel 301. The closure member 800 and the closure device 600 are oriented in the longitudinal direction of the blood vessel 301, as shown in FIG. Figure 8 As shown by arrow 801.

[0434] exist Figure 13 In D, the piston 203 is pushed toward the distal end 804 of the closure device holder 802, and the tip of the closure device 600 exits the closure device holder 802 through the channel 803 and bends outward. The retaining device 202 follows the forward movement of the end 804 of the closure device holder 802 while keeping the closure device 600 and the piston 203 tightly connected.

[0435] exist Figure 13 In E, the closure device 600 is further pushed by the piston 203 in the direction of the distal end 804 of the closure device holder 802, thereby further exiting the closure device holder 802 through the channel 803 and forming the anchor 708. The tip 603 of the closure device 600 engages the vessel wall 301 and penetrates the vessel wall 301.

[0436] exist Figure 13 In F, the closure device holder 802 is withdrawn along with the closure device 600, and the partially released pointed end 603 of the closure device 600, formed like an anchor 708, perforates the vessel wall 301 (see 722). Further withdrawal of the anchor-like closure device 600 can be detected by firm resistance to further withdrawal.

[0437] Pushing the piston 203 further toward the end 804 of the closure device holder 802 will cause each of the two arms 604 of the closure device 600 to complete a semicircular motion, thereby bringing the respective tissue opening ends into proximity and closing the opening 302, somewhat like a single structure for closing the opening 302, as shown. Figure 13 As shown in H.

[0438] Once the closure device 600 is released, the closure device holder 802 including the piston 203 is removed, leaving the deployed closure device 600 still tethered by the holding device 202. The holding device 202 can then be used to position or even retract the closure device 600 if necessary. When the closure of the opening 302 is satisfactory, the holding device 202 is removed, for example, by pulling on one of the arms of the holding device 202.

[0439] The following description combines the retraction unit 100 and the closure member 800 in a set or a medical device, which are deployed simultaneously or one after the other. Figures 14 to 21The sequence shows the closing of the opening 302 by means of two closing members 800 .

[0440] Figure 14 Yes Figure 5 A schematic partially cutaway perspective view of an alternative embodiment of a retraction unit 100 is shown. The retraction unit 100 has two retraction device holders 102, each of which grasps one retraction device 101 to which an engagement device 410 is distally connected.

[0441] The engagement device 410 is preferably a wire loop that can be folded over and captured in the retractor holder 102 .

[0442] The distal ends 110 of the two retraction device holders 102 are deployed in opposing sides of the opening 302 in the tissue 301 .

[0443] Figure 15 is a schematic, partially cutaway perspective view of two retraction devices 101 in an aperture opening 302, with each end 110 positioned on opposite sides of the aperture 302 below the aperture wall 1411. The retraction device 101 is pushed forward to the distal end 110. The engagement device 410 has exited the opening at the distal end 110 of the retraction device holder 102, and the engagement device 410 has unfolded into a loop.

[0444] Figure 16 is a schematic partially cutaway perspective view of two retraction units 100 in an aperture opening 302 with remote ends 110 positioned on opposite sides of the aperture 302 below aperture walls 1411. The two retraction device holders 102 move together with the engagement device 410 in opposite directions as indicated by arrows 1420.

[0445] Figure 17 FIG. 1 is a schematic, partially cutaway perspective view of two retraction devices 101 deployed in a pore opening 302, with the distal ends 110 positioned on opposite sides of the pore 302 below the pore wall 1411. The two retraction devices 101 move in opposite directions, as indicated by arrows 1420, thereby forming a slit in the pore 302. The opposite movement of each retraction device 101 will cease when the opening of the pore 302 forms a straight slit, for example, where the length of the slit is equal to 1 / 400 mm. Figure 15 The engagement member 410 forms a circle having a diameter greater than the minor axis of the slit opening of the aperture 302, which forms a 90-degree angle 1422 with the slit opening. The engagement member 410 prevents unintended upward movement 1421 of the retraction unit, as indicated by arrow 1420. When the engagement member 410 contacts and is unable to pass through the slit opening of the aperture 302, upward movement 1421 of the retraction device 101 is stopped.

[0446] Figure 18 Yes Figure 16 A schematic partially cutaway perspective view of two retraction devices 101 and two engagement devices 410 deployed in a stoma opening 302 is shown, having transformed the stoma into a slit form with simultaneous or sequential deployment of a closure member 800, wherein two closure device holders 802 are positioned between the stoma shoulders, with ends 804 and passageways 803 positioned below the opening of the stoma 302. The closure device 600 is captured and compressed in the closure device holders 802 and oriented at a 90 degree angle to the stoma opening 302, as indicated by the divider 1722 and arrow 801.

[0447] Figure 19 is a schematic partially cutaway perspective view of two retraction devices 101, wherein the engagement device 410 and the closure device holder 802 are shown as Figure 18 802 is shown deployed in the stoma opening 302. The closure device 600 is gradually released in a direction toward the closure device holder end 804 and has exited the closure device holder 802 in the channel 803, forming an anchor 708 that has engaged the wall of the tissue 301 around the opening 302 and the tip 603 of the closure device 600 and perforated the wall of the tissue 301, as shown at perforation 722. Further withdrawal can be detected by a firm resistance to further withdrawal. The closure device holder 802 is then further retracted away from the vessel stoma 302, and the closure device 600 is released.

[0448] Figure 20 302 is a schematic partially cutaway perspective view of two retraction device holders 102 partially retracted from the opening 302 while the engagement device 410 is still deployed in the opening 302. Figure 19 The closure device holder 802 is shown removed. Figure 19 The closure device 600 is shown fully expanded to form a Figure 6 The structure shown in A. The closing device 600 actually makes the free edge 1411 of the opening 302 close and close.

[0449] Figure 21 is a schematic perspective view of tissue 301 having a closed opening 302. The sides of opening 302 have been approximated and closed by closure device 600, which has perforated the tissue as indicated by perforations 722.

[0450] The following description combines the retraction unit 100 and the closure member 800 into one set or one medical device, which are simultaneously deployed in the blood vessel 301. Figures 22 to 25 The sequence shows the closure of an opening 302 in tissue using a closure device 600.

[0451] Figure 22is a schematic, partially cutaway perspective view of two retraction devices 101, wherein an engagement device 410 and a closure device retainer 802 are deployed within a vessel lumen 1006 within an opening 302 in a wall 2204 of the vessel 302. The engagement device 410 is positioned within the vessel lumen 1006 and is oriented in the longitudinal direction of the vessel 301, as indicated by arrow 801. Simultaneously, the closure device retainer 802 is deployed between the retraction devices 101, wherein the opening of the channel 803 is located within the vessel lumen 1006 below the opening wall 2204 and is oriented in the longitudinal direction of the vessel 301, as indicated by arrow 801.

[0452] Figure 23 FIG2 is a schematic, partially cutaway perspective view of two retraction devices 101, with engagement devices 410 and a closure device holder 802 deployed within an opening 302 in the wall 2204 of a blood vessel 302. The engagement devices 410 and the channel 803 of the retraction device holder 102 are positioned below the opening wall 2204 within the vessel lumen 1006. The retraction devices 101 and engagement devices 410 are moved apart in a transverse direction orthogonal to the long axis of the vessel. Each engagement device 410 presses against the inner wall of the vessel 301 in opposite directions. This retracts opposite sides of the opening 302 and expands the opening 302 of the vessel 301 in a direction orthogonal to the long axis of the vessel 301, while simultaneously bringing the oppositely expanded long sides of the opening 302 into close proximity.

[0453] Figure 24 FIG2 is a schematic, partially cutaway perspective view of two retraction devices 101, with engagement devices 410 and a closure device holder 802 deployed within an opening 302 in the wall 2204 of a blood vessel 301. The engagement devices 410 and the channel 803 of the retraction device 101 are positioned below the opening wall 2204, within the vessel lumen 1006. The retraction devices 101 and engagement devices 410 have retracted the opening 302 in a direction orthogonal to the long axis of the blood vessel 301, thereby approximating the relatively long, dilated sides of the opening 302. The closure device 600 is partially deployed, having exited the closure device holder 802 through the channel 803 and formed an anchor 708, which has sufficiently gripped and penetrated the vessel wall 2204, as indicated by perforations 722. Further withdrawal can be detected by firm resistance to further withdrawal. The closure device holder 802 is then further retracted away from the vessel opening 302, and the closure device 600 is released, forming a complete circular configuration, pulling the opening wall 2204 and further approximating the two opposite long, expanded sides 2204 of the opening. Finally, the closure device holder 802 is withdrawn and removed, and the retraction device 101 is removed by pulling the engagement device 410 out of the closure opening 302 as the flexible loop of the engagement device 410 collapses and slides through the shoulder of the closure opening 302.

[0454] Figure 25 1 is a schematic partially cutaway perspective view of a blood vessel 301 having an opening 302 which has been closed by a closure device 600 having perforated 722 the opening wall 2204 to form a straight line orthogonal to the long axis of the blood vessel.

[0455] Figure 26 is a schematic, partially cut-away view from the operator's perspective illustrating the closure of an opening 302 in a patient's blood vessel.

[0456] exist Figure 26 In B, a retraction unit 100 having two arms and a closure member 800 having three closure device holders 802 are deployed in an opening 302 in a patient's blood vessel.

[0457] exist Figure 26 In step C, the engagement devices 410 are moved apart at opposite sides of the opening 302 in a transverse direction perpendicular to the long axis of the blood vessel, thereby retracting the sides of the opening 302. This causes the upper and lower ends of the opening 302 to approach and form a slit opening having two long sides (i.e., distal and proximal) and two short sides (at the transverse sides of the blood vessel). Simultaneously, the closure device holders 802 are moved apart to be evenly spaced along the expanded opening 302.

[0458] exist Figure 26 In D, the closure devices 600 are deployed and each forms an anchor.

[0459] exist Figure 26 In E, the closure device holder 802 is retracted and the closure device 600 engages the wall of the blood vessel 301 around the opening 302 and perforates the wall after further retraction of the closure device holder 802.

[0460] Further withdrawal can be detected by firm resistance to yet another step of withdrawal.The closure device holder 802 is then further retracted from the vessel opening 302 and the closure device 600 is released.

[0461] exist Figure 26 In F, the closure device 600 is deployed to form a circular needle for closing the opening 302.

[0462] exist Figure 26 In step G, the engaging means 410 is retracted. The closing means 600 closes the transverse seam of the opening 302.

[0463] Figure 27FIG2 is a surgeon's view of an opening 302 in a patient's blood vessel 301, illustrating the open surgical closure of the opening 302 using sutures. The opening 302 in the patient's blood vessel 301 is closed using continuous or interrupted sutures 2600 in a straight line perpendicular to the long axis of the blood vessel to avoid stenosis of the patient's blood vessel. This principle of closing an opening in a patient's blood vessel is particularly important and is used in the present invention as follows: Figures 10 to 12 and Figures 22 to 26 As shown, the figures illustrate example methods of operating a medical device.

[0464] Figure 28 2 is a surgeon's view of an opening 302 in a patient's blood vessel 301, illustrating the open surgical closure of the opening 302 using sutures 2600. The opening 302 in the patient's blood vessel 301 is closed using crossing sutures or equivalently purse-string sutures (not shown) that approximate the lateral sides of the opening 302. The approximation of the lateral sides of the opening 302 narrows the vessel lumen, as indicated by arrows 2700.

[0465] Figure 29 FIG2 is a surgeon's view of an opening 302 in a patient's blood vessel 301, illustrating the open surgical closure of the opening 302 using sutures 2600. The opening 302 in the patient's blood vessel 301 is closed using longitudinal sutures. Approximation of the lateral sides of the opening 302 narrows the vessel lumen, as indicated by arrows 2700.

[0466] Only like Figure 27 、 Figures 10 to 12 and Figures 12 to 26 The transverse closure orthogonal to the long axis of the vessel will approximate the proximal and distal ends of the opening 302 and simultaneously expand the lateral sides of the opening 302, thereby avoiding narrowing of the vessel diameter and lumen.

[0467] Figure 30 The closure device 600 is shown in perspective view in an embodiment. The closure device 600 comprises two arms 604, each of which carries an optional pointed end 603. The arms extend from a curled or curved section 605.

[0468] Figure 30A Shown in front view Figure 30 Closure device 600 is shown.

[0469] Figure 31 A closure device 600 in a further embodiment is shown in front view. The closure device 600 comprises two arms 604, each carrying an optional pointed end 603. No curled or bent sections are provided.

[0470] Figure 31A Shown in a three-dimensional diagram Figure 31 Closure device 600 is shown.

[0471] Figure 32 The closure device 600 in an embodiment is shown in front view. The closure device 600 comprises two arms 604, each of which carries an optional pointed end 603. Figure 30 In contrast to the illustrated embodiment, the curled or curved section 605 is not closed, meaning that there is no helical section.

[0472] Figure 32A Shown in a three-dimensional diagram Figure 32 Closure device 600 is shown.

[0473] Figure 33 Part of a medical device according to the invention is shown in perspective. A guidewire 1000 is introduced into the lumen 1006 of a blood vessel 301. The guidewire 1000 continues through a central opening of the medical device, which continues to be indicated as guidewire lumen 115.

[0474] The two engaging devices 410 shrink the opening 302 into a slit.

[0475] Figure 33 If a retraction unit is shown, it can be arranged so that it can be advanced through the guidewire lumen 115, as shown in FIG. Figure 35 Another embodiment of a medical device is shown in FIG.

[0476] Although not shown, the medical device and in particular the engagement means 410 or the retraction means 101 may include a segment that prevents the guidewire 1000 from interfering with the closure device.

[0477] Figure 33A Shown from the front Figure 33 Medical equipment shown.

[0478] Figure 34 A portion of another embodiment of a medical device is shown in a perspective view. The engaging means 410 is constructed from a single metal wire. Figure 34 It can be seen that the retraction device 101, or any other portion of the medical device that is inserted into the lumen of a blood vessel during use, may include a step or bend 420 in any embodiment. The step or bend 420 may interact with the wall of the opening 302 or the blood vessel 301, so that the step or bend 420 provides tactile feedback to the surgeon when the medical device is pulled out of the blood vessel 301. When the surgeon feels the tactile feedback, he or she knows that the medical device is ideally positioned relative to the opening 302 so that the opening 302 can be closed by releasing the closure device 600.

[0479] Figure 35 Part of a further embodiment of a medical device is shown from the side. Figure 35 Shown basically in Figure 33 or Figure 33A However, Figure 35 Also shown in a highly schematic manner are the two closing devices 600 which close the opening 302. The engaging device 410 still has to be folded again and withdrawn from the lumen 1006 of the blood vessel.

[0480] Figure 36 A highly simplified view of the front end surface of a medical device in yet another embodiment is shown having a longitudinal axis L and a cannula 117. As can be seen, the end of the medical device has several openings, one opening housing a guidewire 1000, one opening housing two retraction devices 101, and one opening housing four closure devices 600.

[0481] It goes without saying that the number of openings, retraction devices 101 and closing devices 600 is not limited to Figure 36 In addition, the guidewire 1000 can continue through an opening dedicated to the guidewire 1000. However, the guidewire 1000 can also share its opening with one or more retraction devices 101 and / or closure devices 600.

[0482] Figures 37A to 37F Two additional exemplary embodiments of the closure device 600 are indicated in different views.

[0483] Figures 37A to 37C One of these additional embodiments is shown in a different view. Figure 37A Showing a stereogram, Figure 37B is a front view and Figure 37C The two arms 604 of the linear closure device 600 are optionally assembled together in an optionally non-bent section 607. The assembly can be achieved by welding, gluing, friction welding or other means.

[0484] Furthermore, the two arms 604 are integral with each other, in other words, are not joined to each other.

[0485] Also, the non-bent section 607 (non-bent when the closure device 600 is fully deployed) is only a part of some embodiments and should not be considered limiting.

[0486] relatively Figures 37D to 37F The curved section 605 in the embodiment shown, when viewed from the front ( Figure 37B ) is almost circular and has no turning points, Figures 37D to 37F As discussed in more detail below, the left arm 604 is thus always turned to the left, or bent to the left (see Figure 37B ), the right arm 604 is always turned to the right or bent to the right.

[0487] Figures 37A to 37C The end profile or end section of the arm 604 in the illustrated embodiment is optionally chamfered to form a tip 603 to allow it to easily penetrate the blood vessel wall.

[0488] The closure device 600 is preferably made of a shape memory material such as Nitinol. In this case, the closure device 600 will spontaneously assume or adopt a ring-like shape when released from or located in a blood vessel, and will initially assume or adopt a generally straight shape when located in the closure device holder 802.

[0489] exist Figures 37D to 37F Another embodiment of a closure device 600 is shown in FIG. Figures 37A to 37C The figures show different views.

[0490] Relative to Figures 37A to 37C In the illustrated embodiment, a first section of each arm 604 that is adjacent to or adjacent to a straight or non-curved section 607 of the arm 604 is bent in a first bending direction away from the non-curved section 607 or the other arm 604. In the first bending direction, the bending angle may be between 60° and 120°, preferably between 80° and 100°, and most preferably 90°.

[0491] The second section following the first section is bent at an angle of approximately 360°. The second section can be bent into a second bending direction that is opposite to the first bending direction (first to the left, then to the right, or vice versa). Figures 37D to 37F As shown, the end profile can be cut into a straight line or a nearly straight line. Figures 37A to 37C As shown, the end sides may also be chamfered to a point. Likewise, the non-bent section 607 (non-bent in the fully deployed state of the closure device 600) is only a part of some embodiments.

[0492] It should be noted that Figures 37D to 37F In the embodiment shown, the two arms 604 may each have one (or only one first) first bend to the left and one (or only one second) second bend to the right. Figures 37D to 37F In the illustrated embodiment, the end 603 of a first arm 604 points away from the second arm 604 , while the end 603 of the second arm 604 points away from the first arm 604 .

[0493] from Figures 37D to 37F As can be seen, the design of the closure device 600 in this embodiment enables the left arm 604 to grasp tissue on the left side of the access site. The left arm 604 can pull the tissue toward the right arm 604. Similarly, the right arm 604 can grasp tissue on the right side of the access site. The right arm 604 can pull the tissue toward the left arm 604.

[0494] This design has been shown to provide a tighter, and therefore more reliable, closure of the vessel opening 302. A tighter closure facilitates the goal of closing the vessel opening 302 with fewer and / or smaller closure devices 600.

[0495] Alternatively, the straight or non-curved section 607 can be used to hold and / or push the closure device 600 until it is finally released. Additionally, the section 607 can be used to connect the two arms 604 to each other, for example, in a welding process.

[0496] If arms 604 are made of a shape memory material, they can begin pulling tissue on opposite sides of the vascular opening 302 once unsheathed.

[0497] Figure 38 The handle component 900 of the medical device and the guidewire 1000 are shown, and the guidewire 1000 is advanced into the blood vessel 301 (e.g., a vein) through the opening 302 of the blood vessel 301. The design and use of the handle component 900 and at least some of its mechanisms for pushing and advancing components such as the guidewire 1000, the retraction device 101, etc. will be described below.

[0498] Figure 39 An embodiment of the retraction means 101 and engagement means 410 is shown activated by the handle member 900 .

[0499] In this embodiment, to activate or advance the retraction device 101, in a first step the user pushes the optional first slider 902 in the direction marked by the corresponding arrow (towards the blood vessel 301).

[0500] Likewise, together with the first slider 902, the user moves the optional second slider in the direction of another corresponding arrow (also toward the blood vessel 301). The function of the second slider 904 will be described below.

[0501] The first slider 902 may optionally be locked in its end position or another position. At the end of the first step, the retraction device 101 has not yet been deployed in the blood vessel 301 and has not engaged with the access site. However, the tips of the retraction device 101 have separated from each other.

[0502] In the second step, the handle member 900 is pulled back by the user and directed away from the blood vessel 301 as indicated by the arrow next to the handle member 900 until the user can feel that the retraction device 101 is fully engaged with the engagement device 410 at the access site. In this state, the opposite edges of the slit opening 302 are brought closer together due to the arms of the retraction device 101.

[0503] about Figure 45 Further discussion Figure 39 Optional design of the retraction device 101 and the engagement device 410.

[0504] Figure 40 The (optionally three) closure device holders 802 are shown being urged toward the opening 302 by a mechanism comprised of a handle member 900. The closure device holders 802 may be completely parallel to one another or only partially parallel.

[0505] The ejection of the closure device holder 802 from the closure member 800 and / or the handle member 900 may be activated by an optional switch 906 or another feature of the handle member 900. The switch 906 is arranged to be movable in an opening 908 of the housing of the handle member 900.

[0506] In the first step, the switch 906 is optionally pushed to a first stop point which may be provided by the left end of the opening 908 (see Figure 40 (the position of the middle switch 906).

[0507] In said first step, by operating the switch 906, the closure device holder 802 is extended to its maximum width, ie positioned more or less equidistantly along the opening 302. Figure 40 , which is marked by three small arrows between the closure device holder 802 and the single or multi-lumen extrusion port or opening 910, with the closure device 600 still within the closure device holder 802.

[0508] It should be noted that the closure device holders 802 can remain parallel throughout the closure of the vascular opening 302, or can be arranged to be offset from one another. For example, the closure device holders 802 can be arranged such that adjacent closure device holders 802 are at least partially offset from one another during deployment. For example, the closure device holders 802 can be arranged such that the gap, space, or distance between their tips widens as they are advanced toward the opening 302.

[0509] Figure 40A An optional transfer bracket 806 is shown for three or more parallel closure device holders 802. Figure 40A In, it can be about Figure 40 At the end of the first step described in FIG. 1 , the closure device holders 802 are in a non-deployed state. The closure device holders 802 are separated from each other by a small distance. This separation can be triggered by the design of the transfer bracket 806. The transfer bracket 806 can include a wire mesh or a structure, or a combination of both. The transfer bracket 806 can be a foldable and / or deployable component.

[0510] Optionally, the buffer 807 is optionally configured on the outside or side of the closure member, closure device holder 802 or transfer bracket 807. The buffer 807 is Figure 40B The spacer is shown in the expanded or deployed state of the delivery stent 806 .

[0511] Figure 40B Show Figure 40A The delivery stent 806 in the closure device is in an expanded or deployed state. As indicated by the arrow above the push tube 808, the delivery stent 806 has been deployed by pushing downward. This activation causes the closure device holders 802 to deploy and spread along the slit opening 302. To maintain a small distance between the transverse closure device holders 802 and the outer edge of the slit opening 302, the buffer member 807 acts as a spacer and maintains this small distance during closure of the vessel opening 302.

[0512] Figure 40C A sleeve 914 is shown with an optional U-shaped or V-shaped guide. The sleeve 914 is part of the handle member 900. Another protrusion of the pin or knob 912 is preferably arranged at the rear of the handle member 900 (see FIG. Figure 41 ), or another component connected to the knob 912 can be moved, as is known from the art of so-called mortise and tenon systems.

[0513] Guide channel 916 includes a first channel segment 916a and a second channel segment 916b, each of which is connected to the other by another section, referred to as a turning point 916c. At turning point 916c, when the pin moves along guide channel 916 from first channel segment 916a to second channel segment 916b, or vice versa, the pin initially moves clockwise along guide channel 916 and along the longitudinal axis of sleeve 914, then counterclockwise once it reaches turning point 916c, or vice versa. It should be noted that the pin can be part of knob 912 and guide channel 916 can be part of sleeve 914, or vice versa.

[0514] Therefore, when the knob 912 is rotated in a first direction (e.g., clockwise), the pin moves along the first slot section 916a and eventually enters the turning point 916c of the guide slot 916, and then the knob 912 stops rotating. Therefore, the turning point 916c can be understood as a stopping point.

[0515] In order to further push the sleeve 914 relative to the knob 912 (or vice versa), the knob 912 must be rotated in the second direction (e.g., counterclockwise). The elastic component or spring can ensure that the pin smoothly enters the second slot section 916b when it reaches and is about to leave the turning point 916c.

[0516] Providing the guide groove 916 discussed above can provide the user (surgeon) with tactile feedback indicating that the desired advancement of the sleeve or pin has been achieved, particularly when the guide groove 916 is U-shaped or V-shaped. Further advancement can only be achieved by reversing the direction of rotation of the knob. Therefore, this feature serves as a safety measure. Additionally, the guide groove 916 can improve the accuracy of advancing an assembly (e.g., closure device 600).

[0517] Figure 41Three closure devices 600 are shown being pushed forward within the closure device holder 802 by the mechanism of the handle member 900. In this particular embodiment, the mechanism is activated or operated by turning a knob 912 on the rear portion of the handle member 900 to advance and at least partially release the closure devices 600 to close the opening 302. Reference is made to the discussion above regarding the optional V-shaped guide groove 912.

[0518] Figure 42 Shows how the three closure device holders 802 are pulled back by the mechanism of the handle member 900. In particular, turning the switch 906 to Figure 40 The opposite direction of the discussion (thus, Figure 42 Rotating the handle 800 (to the right) will pull the closure device holder 802 rearward, as shown by the arrow pointing to the rear of the handle member 900.

[0519] At the end of this step, the closure device 600 has closed the opening 302 in its final shape by passing through the edge of the opening 302. The final shape of the closure device 600 can be predetermined when the closure device 600 is manufactured, for example, by using a shape memory material such as Nitinol.

[0520] Figure 43 The retraction device 101 is shown being released from the tissue of the opening 302 by the mechanism of the handle member 900. The mechanism is optionally activated or triggered by pulling back the second slider 904. This step enables the two parts of the retraction device 101 to be separated so that it can be pulled back and away from the blood vessel 301.

[0521] Figure 44 The mechanism of the handle part 900 is shown for completely removing the retraction device 101. In this final step, the first slide 902 is pulled back to the rear of the handle part 900. After this step, the entire handle part 900 system can be removed.

[0522] Figure 45 The enlarged view shows, for example Figure 39 Optional design of the retraction device 101 and the engagement device 410. Figure 45 A tangent line along II is also shown.

[0523] Figure 45 In the exemplary embodiment of the present invention, the retraction unit 100 of the retraction device 101 includes a plurality of (here two) arms, here an arm 101a and an arm 101b.

[0524] The arm 101a of the engagement device 101 comprises two feet 121 and 123. The foot 121 is referred to as the outer foot and the foot 123 as the inner foot, because in the retracted position of the retracting device 101, the foot 121 is further outboard than the more inner foot 123 (see Figure 45 )

[0525] The legs 121 and 123 may be welded to each other at or through the welding portion 125 .

[0526] At the distal end of the weld 125 , the legs 121 , 123 may be separated from each other so as to surround or enclose one or two central openings 127 , which may be through openings.

[0527] The inner leg 121 can be straight or substantially straight. However, the outer leg 123 can be bent so that its outer side (side, see Figure 45 ) has any indentations, projections or depressions.

[0528] The indentations, protrusions, or depressions form the engagement means 410 discussed above. The engagement means 410 can be used to releasably engage tissue. For example, when the medical device is slightly withdrawn from the vessel opening 302, the engagement means 410 can provide tactile feedback to the surgeon to ensure that it is properly positioned on the vessel 301 or its opening 302.

[0529] Due to the specific shape of the engagement means 410, the arm 101a has the shape of a splint.

[0530] What is described for arm 101a also applies to arm 101b.

[0531] Figure 45 As can be seen in FIG, arm 101a and arm 101b each exit from retraction device 100 through respective openings 131 and 133, although arm 101a and arm 101b may also exit through a common opening.

[0532] from Figure 45 As can be seen from the tangent line along line II, at least one opening 131 is designed to have a width that is smaller than the cross-sectional length of the arms 101a and 101b (e.g., in a cross section through the weld 125). To this end, the specific shape of the opening 131 or its opening area, or the aperture inside the retraction unit 100 that follows and ends at the opening 131, is long ( Figure 45 in the up and down directions) in the width ( Figure 45 left and right directions in the .

[0533] Such a shape may be achieved, for example, by selecting an elliptical shape for the opening 131 (or the cross-section of the aperture after opening comprising the retraction device 101 or part thereof before being released in use), such as Figure 45 As shown in .

[0534] This shape prevents the arms 101a, 101b from twisting or rotating (along their longitudinal axes) undesirably during use, particularly when the entire medical device is pulled back into position to release the closure device 600. Preventing the arms 101a, 101b from twisting or rotating helps maximize retraction of the vascular opening 302.

[0535] Of course, any other solution to prevent twisting may be provided in addition or alternatively, for example, pins or protrusions may be arranged to prevent twisting or rotation.

[0536] FIG. 46 is a schematic diagram of another exemplary embodiment of a retraction unit 100 . Figures 46A to 46C Different steps and views for positioning the retraction device 101 in the opening 302 are shown in sequence and will be described in detail below. Figure 46D Another design of a deployment device 103 is shown.

[0537] Figure 46A is an embodiment of a retraction unit 100 comprising a retraction device holder 102 having a retraction device 101 , a deployment device 103 configured to slide within the retraction device holder 102 toward or to an opening 302 .

[0538] The retraction unit 100 can be inserted from outside the patient's body 303, through the patient's skin 304, to the opening 302 of the blood vessel 301 inside the patient's body 305. Figure 46A and Figure 46B As shown, the proximal section of the retraction device holder 102 is optionally located outside the body 303. Figure 46B After positioning the retraction unit and retraction device 101 in the opening 302, the proximal section of the retraction device holder can be manually grasped and secured so that the deployment device 103 can be pulled back as shown by the arrow.

[0539] In this embodiment, the deployment device 103 is releasably positioned within the retraction device holder. The longitudinal axis L of the retraction device holder 102 and the longitudinal axis L of the deployment device 103 are coaxial, preferably as shown in FIG. Figure 46A At least one cross-sectional shape of the retraction device holder 102 and the deployment device 103 is preferably circular or nearly circular. However, Figure 46A It can be seen that some sections (such as the remote section of the retraction device holder 102) may be different, such as Figure 46B As shown in more detail in FIG, the retraction device 101 includes a first arm 135 and a second arm 137 forming a distal section of the retraction device holder 102. The distal ends 112 of the arms 135, 137 are optionally spherical. At least one cross-section of the arms 135, 137 is optionally circular or round.

[0540] Figure 46AThe illustrated configuration of the retraction unit 100 is preferably used to move the remote section 101 of the retraction device holder 102 close to or into the opening 302. The outer diameter DR of the retraction unit 100 corresponds, at least in some sections, to the outer diameter of the retraction device holder 102 and / or the width of the retraction device 101.

[0541] The remote section and / or another section of the deployment device 103 is preferably conical. Figure 46A As shown, it can be configured so that its front end protrudes from the retraction device 101 or the retraction device holder 102. This tip shape can facilitate pushing the retraction unit 100 forward through the patient's tissue. In addition, in this way, the tip can serve as a guide.

[0542] like Figure 46A As shown, the first arm 135 and the second arm 137 of the retraction device 101 can optionally fit tightly against the outer surface of the retraction device holder 102 .

[0543] Figure 46B The arrows in FIG. 1 indicate the steps after positioning the distal end of the retraction device 101 near the opening 302. If positioned correctly, the distal ends 112 of the two arms 135, 137 should have been positioned within the opening 302 so that the arms 135, 137 will retract or expand the deployment opening 302 after the deployment device 103 is pulled back, as shown in FIG. Figure 46B The results of the steps are shown as Figure 46C As described above, the step of pulling back the deployment device 103 is represented by an arrow parallel thereto.

[0544] After the deployment device 103 is fully withdrawn from the retraction device 101 and possibly also from the lumen of the retraction device 101, resulting in respective components 102, 103 as shown in FIG46C, the cross-section of the retraction device holder 102 may change from its first shape, e.g., circular, to a second shape, e.g., elliptical. This change in cross-section may be triggered or influenced by, for example, the particular material or configuration of the retraction device holder 102. For example, it may have shape memory, a shape memory alloy, be made of a braid, etc.

[0545] The change in shape or cross-section of the retraction device holder 102 may occur due to elastic deformation of the retraction device holder 102 or segments thereof when retracted from the lumen of the retraction device holder 102 by the deployment device 103 .

[0546] The process of changing the retraction device holder 102 cross-section from a first shape (eg, circular) to a second shape (eg, elliptical) optionally begins after or while the deployment device 103 is pulled back from the retraction device holder 102 .

[0547] Preferably, the length DN of the oval corresponds more or less to the distance that the opening 302 is fully retracted and / or expanded in order to close the opening 302 with the clamp in the following step. To this end, the cross-sectional shape of the closing device holder 802 is preferably similar to the second shape (which it exhibits once the retraction device holder 102 is separated from the retraction device holder 102), i.e. Figure 46C The following steps will be described in detail with reference to FIG47.

[0548] Figure 46D An alternative design for the distal section of the retraction device 102 is shown. Two recesses 139, open like the distal section and parallel to the longitudinal axis L, are located in the distal section to accommodate the first arm 135 and the second arm 137 of the retraction device 101. The recesses 139 are positioned opposite each other, i.e., at an angle of 180° relative to the circumference of the retraction device holder 102. The recesses 139 facilitate coupling the two arms 135, 137, allowing for easy advancement of the retraction unit 100, comprising the retraction device holder 102 and the retraction device 101, through tissue to the opening 302.

[0549] Figure 46E Another exemplary embodiment of a retraction device 101 is shown. Figure 47B In contrast, arms 135, 137 are truncated. Arms 135, 137 are an integral part of the remote section of the retractor holder 102.

[0550] In some embodiments, where the arms are absent, the distal section of the retraction device holder 102 may, for example, comprise a shape having two notches and two tooth-like peaks. When the cross-sectional shape of the retraction device holder 102 is elastic or otherwise adapted to the oval shape of the closure device holder 802, the peaks may act as retractors.

[0551] FIG. 47 is a schematic perspective view of another exemplary embodiment of a closure device 802 and a retraction device 101 .

[0552] Figure 47A Another exemplary embodiment of a closure device holder 802 is shown. The optionally elliptical cross-section of the closure device holder 802 is designed to fit Figure 46C and / or Figure 47C The retraction device 101 is shown in an oval cross-section. This represents that this exemplary embodiment of the closure device holder 802 can only be opened after the retraction device holder 102 is pulled out of the retraction device 101. Figure 46C The device is shown inserted and / or pushed into the retraction device 101. This feature is advantageous to the user of the medical device because Figure 46A The first step shown involves sliding the retraction unit 100 out to the opening 302. It is not possible to use the closure device holder 802 instead of the retraction device holder 102. For safety reasons, this is excluded.

[0553] Figure 47A The illustrated closure device holder 802 is an exemplary embodiment of a closure device 600 having three parallel guides. The design of the closure device 600 having two arms bent to the side at the distal end of the closure device holder 802 is optional, and other designs are also possible.

[0554] Figure 47B Another exemplary embodiment of a closure device holder 802 is shown. The design of the distal end of the closure device holder 802 can be configured individually, depending on the need to apply the closure device 600 to the respective opening 302 in each case.

[0555] Figure 47B The exemplary embodiment of the closure device holder 802 shown includes several rods 809 with grooves 810 arranged between them. There is an opening at the bottom of the groove 810 for releasing the closure device 600. Figure 47C When the closure device 600 shown in FIG. 1 closes the opening 302 of the blood vessel 301, (wherein the elliptical cross section does not have the smallest diameter as shown in FIG. 1 ) Figure 47A 302), rod 809 acts as a spacer to prevent contact between the opening for releasing closure device 600 and the vessel wall opposite opening 302. Therefore, due to the presence of rod 809, closure device 600 can avoid damaging the side of the vessel opposite opening 302. The length 810 of rod 809 can be selected based on the type or size of the vessel to be treated using the medical device.

[0556] Figure 47C Shown medical equipment, including Figure 47A The closure device holder 802 and the Figure 46C The retraction device 101 shown is used to close the opening 302 of the blood vessel 301.

[0557] Figure 48A 、 Figure 48B The connector 500 having openings 501 , 502 is shown being penetrated successively by the deployment device 103 and then the closure device holder 802 .

[0558] The connector 500 preferably includes a hemostatic valve for preventing blood leakage after the medical device or a portion of the medical device enters the patient's body.

[0559] The connector 500 is preferably disposed at the proximal end of the retraction device holder 102 .

[0560] The connector 500 is preferably designed integrally with the retraction device holder 102 and / or is preferably non-releasably attached to the retraction device holder 102 .

[0561] One or more materials of the connector 500 and the retraction device holder 102, or portions thereof, may be the same or different from one another. For example, the material may be or include plastic.

[0562] The connector 500 is preferably an introducer sheath, for example, for introducing the deployment device 103 and / or the closure device holder 802 into the retraction device holder 102 .

[0563] The connector 500 may include one or more openings, preferably at the proximal end, sealing lips 501, 502 and / or etc. The openings and / or sealing lips 501, 502 may be designed as passive valves to prevent leakage of liquid (preferably blood).

[0564] The openings and / or sealing lips 501, 502 are preferably designed to be penetrated by the deployment device 103 and / or the closure device holder 802. The sealing function is preferably maintained after the deployment device 103 and / or the closure device holder 802 are retracted from the opening. In other words, the openings or sealing lips 501, 502 preferably provide a sealing function when neither the deployment device 103 nor the closure device holder 802 penetrates the sealing lips 501, 502 or passes through the opening, and when the deployment device 103 or the closure device holder 802 is introduced.

[0565] Preferably, the sealing lips 501, 502 (or) at least a portion thereof are tightly fitted with the outer surface of the deployment device 103 and / or the closure device holder 802. Once the deployment device 103 and the closure device holder 802 are introduced into the internal cavity of the retraction device holder 102, the sealing lips 501, 502 (or) at least a portion thereof are used to seal the proximal end of the retraction device holder 102 to prevent blood leakage.

[0566] The opening (or a portion thereof) or the area of the opening of the connector 500 can have a first shape, such as a circle, for receiving a preferably circular deployment device 103. The sealing lip 501 is designed to form a seal with the outer surface of the device having a first cross-section (particularly a circle). The opening and / or the sealing lip 501 can be designed as slits or from slits. Preferably, at least four to six slits, which can be star-shaped, are formed as a portion of a circle. The angles between the slits are preferably 45°, 60°, or 90°.

[0567] At the same time, the opening (or portion thereof) or the area of the opening of the connector 500 may have a second shape, such as an oval, for receiving the preferably oval-shaped closure device holder 802. The oval opening may be covered or closed by a sealing lip 502, which is designed to form a seal with the outer surface of the oval device. The opening and / or the sealing lip 502 may be designed as a slit. Preferably, at least one slit, which may be oriented along the length of the oval, is a portion of a circle.

[0568] Thus, the connector 500 allows both devices having a circular cross-section and devices having an oval cross-section to be introduced into the connector 500 and / or the retraction device holder 102. Additionally, the lips 501, 502 or sealing membranes thereof can form a seal with the outer surface of the device, regardless of whether the device has a circular or oval cross-section.

[0569] The connector 500 preferably includes a port for connecting an irrigation catheter 503. The irrigation catheter 503 can be integral with the connector 500. The irrigation catheter 503 can be used to degas the connector 500 and / or administer medications and / or fluids to the patient. The irrigation catheter 503 can be designed as an outer sheath irrigation catheter 503.

[0570] Figure 49 A perspective view of a portion of a medical device according to another embodiment of the present invention is shown. The portion of the medical device is introduced into the lumen 1006 of a blood vessel 301 through an opening 302 .

[0571] A certain number of arms 101a, 101b (four in this exemplary embodiment, more or fewer arms may be provided in other embodiments) are provided as the retraction unit 100 or a portion thereof. Figure 49 As shown, when the arms 101a, 101b are pushed into the opening 302, the arms 101a, 101b retract the opening 302 into a slit. Figure 49 In FIG. 1 , the arms 101 a , 101 b are in their advanced position, in which they extend out of the sleeve 117 of the retraction unit 100 .

[0572] In this embodiment, some or all of the arms 101a, 101b are arranged on a straight line or a common plane, or contact or intersect the common plane. In this way, the arms 101a, 101b can expand the opening 302 into a slit shape, while the arms 101a, 101b themselves can still be easily retracted from the slit because the retracting unit 100 is still relatively flat or knife-shaped.

[0573] In some specific embodiments, the lengths of the arms 101a, 101b are different from each other. Thus, two or more different lengths may be provided for the arms. Figure 49As shown, the outer arm 101a is shorter than the inner arm 101b, and the inner arm 101b is arranged between the outer arms (or the inner arm extends or protrudes from the retraction unit 100, the common outer sheath or its sleeve 117 to a greater extent than the outer arms), so that the group of arms appears conical or triangular in plan view. It should be noted that in another embodiment, the longest or most advanced arm of the arms 101a, 101b is not one of the inner arms 100b, but can be any other, such as one of the outer arms 101a.

[0574] Thus, in some embodiments, the retraction unit 100 may include or consist of several arms. Some of the arms may be of different lengths or extend outward from the interior of the retraction unit 100 to different degrees.

[0575] Additionally, in some embodiments, all or some of the arms 101a, 101b of the retraction unit 100 can be arranged to be advanced to an advanced position and retracted from the advanced position without being bent. For example, the arms can be straight or longitudinal components that are not bent during use or that always remain parallel to one another (or both). Thus, in some embodiments, the arms will not assume a configuration other than their unadvanced configuration (e.g., due to shape memory properties).

[0576] Figure 49 There are also some optional protectors 101d, each protector 101d is connected to one arm 101a or 101b, wherein one or more protectors 101d can be connected to a specific single arm 101a or 101b. Figure 49 In the example of FIG. 1 , one arm 101a, 101b may be connected to one protector 101d on its upper surface and to another protector 101d on its lower surface (see FIG. 1 ). Figure 49A ).

[0577] Some or all of the protector 101d may include or be composed of a material having shape memory properties. In this manner, or by any other suitable mechanism, when the protector 101d (or an arm connected thereto) is advanced and removed, for example, from the sleeve 117 of the retraction unit 100, it may assume a shape that is different from that when the protector 101d is still inside the sleeve 117. Optionally, the constriction 141, clamp, or bottleneck may assist or force the protector 101d to a so-called deployed position or shape (e.g., Figure 49 and Figure 49A and the folded position or shape it assumes when still within the sleeve 117 (this position or shape is shown in FIG. Figure 49 (not shown) changes between.

[0578] The protector 101d may be arranged to deploy in a direction which is preferably (or also) perpendicular to the longitudinal axis of the retraction unit 100 or the individual arms 101a, 101b.

[0579] The protector 101d may be arranged to unfold in a direction which is preferably (or also) perpendicular to the direction of maximum extension of the retraction unit 100 or the individual arms 101a, 101b in the width B of the retraction unit 100 or its sleeve 117.

[0580] from Figure 49 It can be seen that the width B of the sleeve 117 (in Figure 49 in the left and right directions) is greater than its width W (see Figure 49A ), so that the cross section of the sleeve is not circular but a flat rectangle, oval or the like.

[0581] Figure 49A Shown from the side Figure 49 Chinese medical equipment passed Figure 49 The three closure devices 600 shown close the opening 302. Figure 49A A range of widths W of the sleeve 117 can be found.

[0582] Figure 49A The retraction unit 100 is shown partially introduced into the opening 302 at an exemplary angle of 45°.

[0583] Figure 49 The design discloses several mutually independent features that can effectively close larger vein and artery orifices. By using three or more closure devices 600, hemostasis can be achieved without leakage.

[0584] Figure 49 and Figure 49A The closure device 600 shown may be Figure 50 and Figure 50A Alternatively, it may be any other known closure device or stapler described herein.

[0585] Figure 50 A perspective view (from the right side) is shown of yet another embodiment of a closure device 600. The closure device 600 includes two arms 604a and 604b, each equipped with an optional tip 603. The closure device 600 is shown in a curled position when bringing together the edges of a slit (i.e., after being released from a medical device).

[0586] Arms 604a and 604b may be from a common rolled or bent material, or glued, welded, or connected to each other in any other manner in the attachment area 609 .

[0587] Depend on Figure 50 (See also Figure 50A ) It can be seen that the shape of the closing device 600 is asymmetrical.

[0588] exist Figure 50In a particular embodiment, the asymmetry of the closure device 600 is achieved by tilting the optional attachment area 609 to the right. This asymmetry facilitates release of the closure device 600 from a medical device, such as by an optional push rod, such as the push tube 808 disclosed herein. Figure 49A As shown, the asymmetry and tilt of the attachment area 609 can help transfer the force applied by the push rod when the medical device is used (see Figure 49A ). Furthermore, the inclination of the attachment region 609 aids the surgeon in inserting the medical device or retraction device 100 into the tissue or opening 302. The medical device can be inserted, for example, at a 45° angle to the tissue surface. However, the tips of the arms 604a and 604b can remain perpendicular to the vessel wall when entering the wall tissue.

[0589] Thus, the attachment area 609 may be inclined at an angle of 20° to 60°, preferably between 30° and 50°, to a line perpendicular to the line of maximum width ( Figure 50 left and right directions in the .

[0590] As an optional feature, the attachment area 609 may include a through-port 611. The through-port 611 may have a closed circumference, or may be Figure 50 , the extension 611a can be open to the circumference. The extension can be narrower than the radius of the opening 611 itself. Therefore, the extension can change the overall shape of the opening 611 into a keyhole shape. The extension can be a bottleneck that is in one plane with the main area of the opening 611.

[0591] The wires of arms 604a and 604b preferably include or consist of flat wires. In contrast to round wires, flat wires lack a circular cross-section. Their cross-sections are elliptical, rectangular, or otherwise deviate from a circular design. Flat wires provide a higher grip without exceeding the irreversible strain threshold of, for example, nitinol. Furthermore, closure device 600 appears to be able to secure a vessel wall with a significant amount of perivascular tissue and gather it to achieve hemostasis and complete closure.

[0592] Figure 50A Show Figure 50 Another perspective view (from the left side) of the closure device 600.

[0593] Figure 51 A closure device 600 according to one embodiment of the present invention is shown in a first state. The closure device 600 may comprise a medical device according to the present invention. Furthermore, the closure device 600 may be used in a method according to the present invention.

[0594] The closure device 600 comprises or consists of two arms 604a, 604b.

[0595] The closure device 600 is designed so that the distal ends of the tip 603 or arms 604a, 604b are in a state where the closure device 600 is not fully deployed (e.g. Figure 51 ) can end in the same plane, which is inclined to the longitudinal direction of the proximal ends and adjacent ends of the arms 604a, 604b. The angle of the inclination can be between 20° and 60°, preferably approximately 45°.

[0596] Figure 51A Show Figure 51 The closing device in the embodiment is in the second state, which may be the final state of the closing device 600 closing the opening 302.

[0597] like Figure 51A As can be seen, there is an attachment area 609 where the proximal ends or other portions of the arms 604a, 604b are connected to each other.

[0598] Figure 51B Show Figure 51 The arms of the closure device in the embodiment are disengaged from each other.

[0599] like Figure 51B As can be seen, the asymmetry of the closure device 600 is a result of using two differently shaped arms 604a, 604b when manufacturing the closure device 600.

[0600] Figures 51 to 51B The closure device 600 has every feature of any other closure device disclosed herein, particularly Figure 50 and Figure 50A Public features.

[0601] Those skilled in the art will appreciate that, although this description is of preferred embodiments, the invention and this description are in many respects illustrative and non-restrictive, and are susceptible to various modifications and alternatives. Changes may be made in detail, particularly in the shape, size, material, and arrangement of parts, without departing from the scope of the invention. However, it should be understood that the invention is not limited to the specific forms or methods disclosed, but rather is intended to cover all modifications, equivalents, and alternatives.

[0602] Therefore, the scope of the invention is defined in the following claims.

Claims

1. A medical device for closing an opening in a patient's tissue, characterized in that The medical equipment includes: a plurality of closure device holders, each for releasably receiving one or more closure devices, at least a portion of each closure device being formed from a deformable shape memory alloy and at least partially contained within the closure device holder in a stressed state such that when the closure device is manipulated to exit the distal end of the respective closure device holder during use of the medical device, the closure device releases its stress or a portion of its stress; and a retraction unit for contacting opposite sides of the opening and for retracting the opposite sides and / or for expanding the opening so as to change the shape of the opening into a slit, wherein a plurality of arms are provided as the retraction unit or a part of the retraction unit; The medical device comprises at least one rod arranged between or adjacent to the openings of the closure device holder for withdrawing the closure device, the at least one rod being arranged to protrude over an opening area of at least one opening of the closure device.

2. The medical device according to claim 1, wherein The retraction unit comprises: at least one retraction device holder; and At least one retraction device is selected from the group consisting of a retraction device at least partially received in the retraction device holder, a retraction device at least partially releasably received in the retraction device holder, and a retraction device arranged in a movably manner relative to the retraction device holder.

3. The medical device according to claim 2, wherein The retraction unit at least comprises: The retraction device has at least one of the following: a first side and an opposite second side; a first arm of the retraction device and a second arm of the retraction device; a first retraction device and a second retraction device; a first retraction device holder and a second retraction device holder; and a first engaging device and a second engaging device; as well as A mechanism for moving the first side away from the second side, moving the first arm of the retraction device away from the second arm of the retraction device, moving the first retraction device away from the second retraction device, moving the first retraction device holder away from the second retraction device holder and / or moving the first engagement device away from the second engagement device.

4. The medical device according to claim 1 or 2, characterized in that The plurality of closure device retainers are arranged to remain at least partially parallel to each other throughout the entire process of closing the opening, or to separate from each other when the closure member is pushed toward the opening and / or away from the opening.

5. The medical device according to claim 1 or 2, characterized in that A transfer bracket is provided for ensuring or assisting the plurality of closure device holders to separate from each other when being advanced toward and / or away from the closure member.

6. The medical device according to claim 1 or 2, characterized in that A plurality of buffer members or a plurality of spacers are arranged on the side of the closing component, the plurality of closing device holders or the transfer bracket.

7. The medical device according to claim 1 or 2, characterized in that A handle component is included, wherein the handle component includes a sleeve, a rotatable component with a guide groove, or a cylindrical component with a guide groove.

8. The medical device according to claim 7, wherein The handle member, the knob or the sleeve itself comprises a resilient component arranged to guide the pin through a turning point of the guide slot.

9. The medical device according to claim 3, wherein: The first retraction device includes a plurality of arms, and at least one of the arms of the first retraction device includes two legs, and the two legs surround at least one opening between the two legs.

10. The medical device according to claim 1 or 2, characterized in that When the medical device is in use, the arm passes through at least one opening of the retraction unit and exits, and the at least one opening of the retraction unit has a width smaller than its length.

11. The medical device according to claim 2, wherein At least one arm of the retraction device passes through at least one opening of the retraction unit and exits therefrom, and the at least one opening of the retraction unit has an elliptical opening area.

12. The medical device according to claim 1 or 2, wherein: The closing device has a first arm and a second arm, wherein at least one of the first arm or the second arm of the closing device has a first bending direction and a second bending direction.

13. The medical device according to claim 12, wherein In the closed state of the closure device or the opening, the end or tip of the first arm of the closure device points away from the second arm of the closure device, and the end of the second arm of the closure device points away from the first arm of the closure device.

14. The medical device according to claim 2, wherein A deployment device is configured to be at least partially releasably received within the lumen of the retraction device holder.

15. The medical device according to claim 2, wherein The retraction device is disposed at a remote section of the retraction device holder, wherein the retraction device and the retraction device holder are designed to be integral with each other.

16. The medical device according to claim 15, wherein The retraction device comprises a first arm and a second arm, and at least when or before the retraction unit is placed into the opening, the first arm of the retraction device and the second arm of the retraction device are placed or provided parallel to each other.

17. A medical device as described in claim 16, wherein the first arm of the retraction device and the second arm of the retraction device are arranged on the surface of the deployment device and / or contact it when the retraction device is advanced into the opening, and wherein the first arm of the retraction device and the second arm of the retraction device are expanded to a retracted state to retract the opening after the deployment device is pulled out of the retraction device holder.

18. The medical device according to claim 2, wherein The retraction device holder or lumen thereof exhibits a first shape or first cross-section when the retraction device is placed into the opening, and exhibits a second shape or second cross-section after the deployment device is partially or completely pulled out of the retraction device holder.

19. The medical apparatus of claim 18, wherein the shape or cross-section of the closure device holder is primarily characterized by or corresponding to the second shape and / or an elliptical cross-section.

20. The medical device according to claim 2, wherein The closure device holder is at least partially releasably received in the retraction device holder and is translationally movable in a longitudinal direction of the closure device holder.

21. The medical device according to claim 2, wherein A connector is included connected to, or as an integral part of, the retraction device holder, the connector providing an opening for pushing a deployment device and / or the closure device holder into the interior lumen of the retraction device holder.

22. The medical device according to claim 21, wherein Wherein at least one of the internal lumen of the connector or a cross section thereof and an opening area of the opening of the connector include a plurality of segments at least partially defining a circle and at least partially defining an ellipse.

23. The medical device of claim 1, wherein: The plurality of closing devices are respectively a U-shaped nail or a clip.

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