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 passage through the tissue and / or a connection with a blood vessel or other body cavity (hereinafter referred to as an opening) of a patient's tissue (301), the medical device comprising: a closing device holder (802) for receiving one or more closing devices (600) in a releasable manner; 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) is changed to a slit or an opening (302) that is like a slit or more like a slit, or to expand or increase 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 according to the preamble of claim 1 and a method for closing an opening according to the preamble of claim 27 .

[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 specifically for closing openings in blood vessels or other body lumens; and more specifically, to a closure device for use in closing openings in body organs or blood vessel walls, 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 the introduction sleeve can be advanced on the guide wire into the vessel or other body organ (Seldinger technique). Such sleeves are usually flexible tubes, which have thin walls and diameters up to about 30F or larger in the range to match the needs of the therapeutic system utilized. The proximal end of the sleeve is kept outside the patient's skin, usually used with a hemostatic valve to prevent blood from flowing through the sleeve from the blood vessel. Then, a catheter or other device can be passed through the lumen of the introduction sleeve and advanced on the guide wire to the position for performing medical surgery. Puncture is used for a variety of 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 a puncture in a body organ or a 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 femoral vein is usually used as the entry point into the patient's system. For interventional procedures, the diameter of a typical puncture can range from 2mm to greater than 10mm or from 6F to greater than 30F.

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

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

[0006] Such punctures may be closed and tightly sutured in a common open surgical approach using either a single knot or a continuous surgical suture.

[0007] An alternative open surgery for hemostasis is the use of clips or staples. March et al., in US 4,217,902, show a form of hemostatic clip that requires open surgical access to the perforation to allow the clamping mechanism to operate. And more complex surgical staplers are described, as shown in US 2008 / 272173 by Coleman James et al., that require open access.

[0008] Various procedures and devices have been developed to address the problem of hemostasis following puncture of a blood vessel for diagnostic or therapeutic procedures in a closed, nonsurgical 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 vessel opening. Such pressure may be required for a relatively long time, for example 30 minutes to up to 1 hour, during which time the patient is bedridden, essentially immobile, 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. Such a procedure is 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 by applying collagen or polymer plugs, as shown in US5275616. 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 manipulated percutaneously.

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

[0015] In surgeries to perforate body cavities and organs, such as thoracoscopic surgery, laparoscopic surgery or endoscopic surgery, a trocar with a suitable size large enough to insert the applicable system is usually used to enter the patient's body. Closure of such large-bore perforations is usually accomplished by suturing in open surgery. Summary of the invention

[0016] An object of the present invention may be to provide yet another medical device and method for closing an opening.

[0017] The above object is achieved by a medical device for closing an opening having the features according to claim 1. The above object is also achieved by a method for closing an opening having the features according to claim 27 .

[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 that is obvious to a person skilled in the art, a person skilled in the art should understand, for example, "one" as including "at least one". The present invention also includes the following interpretation of this understanding: for example, a numerical term such as "one" may alternatively mean "exactly one", as long as this is obviously technically feasible for a person skilled in the art. The present invention includes both interpretations and the interpretations apply to all numerical terms used herein.

[0020] Therefore, the present invention provides a medical device for closing an opening, an incision, a puncture, a passage through tissue and / or a communication port with a blood vessel or other body cavity (hereinafter referred to as: opening) in a patient's tissue. In this context, the medical device includes a closure device holder for receiving and / or holding one or more closure devices in a releasable manner. The medical device also includes a retraction unit, which contacts opposite sides of the opening to retract the opposite sides and / or to expand the opposite sides so that the opening changes its shape into a slit or an opening that is like a slit or more like a slit, as required. Such a change can expand or increase the size or diameter of the opening in at least one or exactly one dimension of the opening.

[0021] Furthermore, a method for closing an opening in tissue is proposed. The method firstly comprises the step of providing a medical device according to the invention and secondly comprises the step of closing the opening by using the medical device.

[0022] Advantageous developments of the invention are each the subject matter of the dependent claims and the exemplary embodiments.

[0023] Whenever an embodiment is mentioned herein, this represents an exemplary embodiment in accordance with the present invention.

[0024] Embodiments according to the invention may include one or several of the features mentioned above and / or below in any technically feasible combination.

[0025] In some embodiments, the retraction unit of the 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 can preferably be at least partially received in the retraction device holder. The retraction device can be at least partially received in the retraction device holder in a releasable manner as required, and is preferably arranged there in a movable or slidable manner relative to the retraction device holder.

[0026] 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.

[0027] In various 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.

[0028] 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 shape or a combination thereof.

[0029] In various embodiments, the engagement means may include or consist of a wire.

[0030] In some embodiments, the engagement means may be formed from a single wire.

[0031] In various embodiments, the engagement means may have or cover a convex or concave shape. In other embodiments, the engagement means is flat or substantially planar.

[0032] 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.

[0033] A mechanism may be provided for moving the engagement means and / or the retraction means into or out of the retraction means holder.

[0034] In various embodiments, an engagement device may be connected to the retraction device described above such that it is used to engage tissue surrounding the stoma from within the stoma opening or from below the stoma opening.

[0035] 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 a retraction device holder. In particular, the at least two retraction devices and / or at least two engagement devices 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 device or a mechanism configured to be manipulated when necessary, in particular to be positioned below the opening level of the opening to be closed.

[0036] In a number of embodiments, the retraction device holder and / or the retraction device and / or the engagement device of the medical device according to the invention are configured to retract opposite sides of the opening, in particular to cause the opening to change its shape. For example, the opening may be changed from a fairly round shape to a slit opening. Preferably, this results in a transverse diameter after extension being at least twice the length of the longitudinal diameter of the opening after retraction. "Transverse" may refer to a direction perpendicular to the longitudinal direction of the vessel. The longitudinal diameter may continue in the direction of the longitudinal axis of the vessel.

[0037] In some embodiments, the retraction unit of the medical device according to the present invention comprises at least a retraction device having at least one of the following:

[0038] - a first side and an opposite second side,

[0039] - first arm and second arm,

[0040] - a first retracting device and a second retracting device,

[0041] - a first retraction device holder and a second retraction device holder, and / or

[0042] - A first engagement means and a second engagement means.

[0043] 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.

[0044] In various embodiments, the mechanism comprises or consists of shape memory properties.

[0045] In some embodiments, the mechanism may include or consist of mechanical components, such as gears, levers, actuation components, control components such as knobs or handles, etc.

[0046] In several embodiments, the mechanism may include or consist of a vacuum device that is configured to modify the shape of the retraction device, the retraction unit, or any other component so that the first side or the first arm, etc. moves away from or away from the second side or the second arm, etc.

[0047] The vacuum device may be arranged to suck a fluid (e.g. air) from a preferably closed inner cavity of, e.g., a retraction unit, such that the cross section of the component, e.g., the retraction unit, is changed: by attempting to achieve a vacuum in the inner cavity, e.g., 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, e.g., the opposite first and second sides of the retraction unit will move away from each other, while the circumference of the retraction unit remains constant.

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

[0049] In some embodiments, the retraction unit or retraction device has a bend or step, or is bent on its front side or its rear side, which can be used as a stopper or tactile feedback to the surgeon when the medical device is partially withdrawn from the vascular 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 vessel or perforation. This in turn indicates that the medical device is in a suitable position for deploying the closure device. In order to achieve this, the bend, step, etc. are arranged below a predetermined distance from the free end of, for example, the medical device or the retraction device. In addition, the bend, step, or position that causes the bend to occur can play a protective role, preventing the medical device from being pulled out too far from the vascular lumen before releasing the closure device.

[0050] In various embodiments, a medical apparatus according to the present invention comprises a closure device contained in a closure device holder.

[0051] In some embodiments, the closure device of the medical device according to the present invention is at least partially contained in the closure device holder in the stressed state of the closure device. In particular, the closure device is contained in the distal end of the closure device holder, in particular 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.

[0052] In various embodiments, the closure device of the medical device according to the present invention is contained within a closure device holder, so that when the closure device is manipulated during use of the medical device to withdraw from the distal end of the closure device holder, the closure device releases its stress or a portion thereof, for example, by bending the two or more arms outside the closure device holder. Thereby, the two or more ends are arranged to perforate the inner wall of the tissue surrounding the opening.

[0053] In some embodiments, at least a portion of a 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.

[0054] In various embodiments, at least a portion of the closure device, the retraction device, the retraction device retainer and / or the engagement device of the medical device according to the present invention is made of Nitinol.

[0055] 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 bioabsorbable material.

[0056] In various embodiments, the biocompatible and / or bioresorbable material is at least one material selected from the group consisting of Ti, Ti alloy, Nitinol, stainless steel, polymeric materials, and ceramics.

[0057] In some embodiments of medical devices according to the present invention, when in an unstressed state, the closure device or parts thereof are curled into a closed form (eg, having a through opening surrounded by arms, struts, etc. of the closure device).

[0058] In various embodiments of the medical device according to the present invention, the closure device or parts thereof are curled into a loop or ring or circular shape when in an unstressed state.

[0059] In various 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.

[0060] 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).

[0061] In various embodiments of the medical device according to the invention, the pushing means is or comprises a rod or a piston.

[0062] In some embodiments, the medical device according to the present invention further comprises a holding or withdrawing device extending through the proximal end of the closure device holder for manipulating the closure device. In this context, the holding device is specifically attached to or connected to the closure device in a releasable manner.

[0063] In various embodiments, the retaining means of the medical device according to the present invention is a string or a suture.

[0064] 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 the grooves.

[0065] In various embodiments of the medical device according to the 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 when the medical device is manipulated or when the user requests it. 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 exceeded by the distal end in the distal direction of the closure device holder.

[0066] In some embodiments of the medical device according to the 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, in particular on the circumference of the closure device holder.

[0067] In various embodiments of the medical device according to the present invention, the retraction device holder is or comprises an elongated tube. This elongated tube comprises or consists of, for example, metal or plastic, and is preferably configured to capture the retraction device. The closure device holder may have a distal end and a proximal end, the distal end being adapted to be advanced or extended through or into an opening in the tissue, the proximal end being particularly adapted to provide an access port for manipulating the closure device when the closure device is received in the closure device holder.

[0068] 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 elements of the medical device and / or relative to a sleeve or outer sheath of the medical device.

[0069] In some embodiments, the medical device comprises a housing, sheath or cannula that includes some or all elements of the medical device (except, of course, the housing or cannula, etc.), specifically a closure device retainer and / or a retraction unit.

[0070] In some embodiments, the medical device includes an inner cavity for guiding and / or surrounding a guide wire. The inner cavity can be open to both the distal end and the proximal end of the medical device, or only to one of them.

[0071] In some embodiments, the medical device includes multiple lumens or openings. For example, one of the lumens or openings may accommodate a first closure device holder, and another may accommodate a second closure device holder, a retraction device holder, and / or any other element of the medical device.

[0072] Any lumen of the medical device may be a through-opening of the medical device, preferably extending in the longitudinal direction of the medical device.

[0073] 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 the length.

[0074] In various embodiments of the method according to the present invention, the method further comprises the following steps:

[0075] - introducing parts of the retraction unit into the opening;

[0076] - bringing opposite sides of the opening into contact with the retraction unit or an element comprised therein;

[0077] - using the retraction unit or the elements it comprises to retract the opposite sides of the opening and / or expand the opening; and

[0078] - 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.

[0079] In some embodiments of the method according to the 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 a slit or a slit-like or more slit-like opening. Such a change may cause the opening to expand or increase in size or diameter in at least one or exactly one dimension of the opening.

[0080] In some embodiments, at least one of the closure device retainer and the retraction device retainer is a partially hollow tube.

[0081] In some embodiments, at least one of the closure device retainer and the retraction device retainer is arranged within a common sleeve or housing, preferably slidable or movable relative to the sleeve.

[0082] In some embodiments, the closure member is identical to the closure device holder.

[0083] In some embodiments, the retraction unit is identical to the retraction device holder.

[0084] In some embodiments, the retraction unit and the closing member are implemented by only one device.

[0085] 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.

[0086] In some embodiments, the closure device is a staple or a clip.

[0087] 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 substantially perpendicular to the first direction.

[0088] 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 used to plastically deform the closure device when ejecting or releasing. In addition, preferably no device is provided for closing the closure device.

[0089] 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 eject from a common opening of 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 through separate openings but simultaneously.

[0090] 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.

[0091] In some embodiments, the closure device holder is configured so 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.

[0092] In some embodiments, the retraction unit comprises at least two elements, such as two sides, two arms, two retraction devices or two retraction device holders, which move apart from each other when retracting the opening.

[0093] In some embodiments, the retraction unit and the closure device holder are separate from each other and, in particular, can be moved separately from each other. In other embodiments, the retraction unit and the closure device holder are interconnected to each other or implemented by the same unit so that they cannot be moved independently of each other.

[0094] 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.

[0095] In some embodiments, at least one of the components of the retraction unit configured to retract the opposite sides of the opening by directly touching the opposite sides 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.

[0096] 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 engaging device and the second engaging device) does not include one or more hinges, joints, joints or segments at its bending point, specifically in its middle section, and more specifically in opposite directions facing each other.

[0097] In some embodiments, a component of the retraction unit configured to retract opposite sides of the opening by directly touching the opposite sides of the opening has a free distal end.

[0098] In some embodiments, some or all components of the retraction unit that are configured to retract the 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 closing device extends completely or substantially in a second plane (e.g., in the deployed state of the closing device, for example, when released or ejected). In addition, the closing device may be closed in the second plane as needed. For example, the closing device may include arms or tines that move toward each other when closed or deployed. The movement may also occur in substantially one plane, namely 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.

[0099] In some embodiments, some or all of the components of the retraction unit that are configured to retract the 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 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 direction and the second direction may be different from each other. In fact, the first direction and the second direction 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 is closed when the surgeon uses the device.

[0100] In some embodiments, the first and second retractors or their first and second arms or sections are connected to each other only by a hinge or joint or a hinge or joint section. The hinge or joint or section may be arranged to preferably move only within the retractor holder and / or along the longitudinal axis of the medical device or retractor holder. In addition, or as another option, the hinge or joint or section may 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 section may not move in the direction of being retracted or expanded on opposite sides of the aperture as required.

[0101] According to the present invention, a medical device for closing an opening in a tissue is also provided, comprising:

[0102] - a closure device holder, wherein the closure device holder has a distal end and a proximal end, the distal end being adapted to extend through the opening in the tissue in a deployed state of the medical device and the proximal end being adapted to provide access for manipulating the closure device; and

[0103] - a closure device, at least partially captured in a stressed state within a distal end of a 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 junction connected to the two or more ends via two or more arms;

[0104] The closure device is configured relative to the closure device holder so 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 the closure device, the closure device releases its stress by bending the two or more arms out of the closure device holder, thereby the two or more ends perforate the inner wall of the tissue surrounding the opening.

[0105] According to the present invention, a method for closing an opening in a tissue is also provided, the method comprising the following steps:

[0106] - providing a medical device according to the invention;

[0107] - Use medical devices to close the opening.

[0108] In some embodiments according to the present invention, at least a portion of the closure device is made of a deformable shape memory alloy.

[0109] In some embodiments according to the present invention, at least a portion of the closure device is made of Nitinol.

[0110] 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.

[0111] In some embodiments according to the present invention, the biocompatible and / or bioabsorbable material is at least one material selected from the group consisting of Ti, Ti alloy, Nitinol, stainless steel, polymeric materials and ceramics.

[0112] In some embodiments according to the present invention, the closure device is curled into a closed form when in an unstressed state.

[0113] 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.

[0114] In some embodiments according to the 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.

[0115] 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.

[0116] In some embodiments according to the present invention, the pushing device is a rod or a piston.

[0117] In some embodiments according to the present invention, the medical device 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.

[0118] In some embodiments according to the present invention, the retaining device is a string or a suture.

[0119] In some embodiments according to the present invention, the closure device holder has one or more grooves on the inner wall of the closure device holder and / or one or more grooves on the pushing device for guiding the holding device along the longitudinal direction of the closure device holder.

[0120] 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.

[0121] In some embodiments according to the present invention, the distal end of the closure device holder has two channels arranged opposite to each other on a wall of the closure device holder.

[0122] Most current state of the art systems, such as those utilizing plugs, clips, or sutures, can only close relatively small arterial punctures up to 10 French and are only approved for use at arterial access sites. Some systems are used off-label to close larger arterial or venous punctures.

[0123] The present invention may advantageously provide a more effective method and medical device for sealing large orifice punctures in veins up to 30 French and larger and other passages through tissue.

[0124] The present invention allows for the joining together of tissue segments, or the closing and / or sealing of openings through tissue, such as very large orifice vascular punctures in the venous system, in particular in the femoral vein.

[0125] Such large vascular access ports and perforations are required for more complex interventional procedures such as transseptal mitral and tricuspid valve repair and prosthetic implantation.

[0126] The diameter of the femoral vein is about 8 mm or 24F, or even larger, allowing the introduction of systems with similar diameters. It is very challenging to close such large ostial perforations of the vein by percutaneous systems utilizing plugs, sutures, or clips. When closing such large ostial perforations in a circular or longitudinal manner, the risk of vascular stenosis is high.

[0127] According to the present invention, a specific technique is advantageously used to stretch the perforation in a direction orthogonal to the long axis of the vessel, and the perforation is tightly sutured along the stretching. In this way, the vessel lumen is avoided from narrowing.

[0128] The present invention allows for the closure of large orifice vascular 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.

[0129] In some embodiments, the medical device may include a handle component and a tube set, which is coupled to the handle component on one side (not shown in the figure) and coupled to a retraction unit and a closure component that are deployed in the tissue opening in sequence or simultaneously on the other side. The handle component may also include any number of mechanisms required to deploy the retractor and closure components (not shown in the figure). The retraction unit and closure components are deployed through a cannula that allows these units and components to be at least partially disposed in the opening or lumen of the vessel in a controlled manner, specifically along a guide structure, such as a guide wire or other track (not shown in the figure) that is typically placed in the vessel for performing interventional procedures.

[0130] The retraction unit optionally comprises two retraction device holders, the distal ends of which are configured to extend through the opening and be positioned at the 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 vessel, for example by contacting, pushing and / or abutting the opposite ends of the opening. Each engagement device is configured to move separately so as to retract the opposite sides of the opening and stretch the opening, which brings the opposite sides of the opening closer between the retraction devices, so that the opening becomes straight with an extended long diameter and an orthogonal retracted short diameter.

[0131] 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, for example, a closure device mounted at the distal end. The closure device is arranged to engage the tissue wall when the closure device holder is withdrawn.

[0132] 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 with the tissue wall, the engagement can be detected by a firm resistance to further withdrawal.

[0133] The closure device is then deployed, further bent 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.

[0134] The closing device may include a plurality of circular needles as needed, the size, orientation and form of the circular needles being such that when the closing device moves outward from the interior of the opening, the closing device bends in an anchor-like manner according to a preset memory shape of the closing 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.

[0135] The closure device or devices may be detached from the closure device holder and delivery mechanism as desired and left in place.

[0136] In the case where the tissue opening is closed in this manner, blood pooling can be achieved in the 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.

[0137] 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 connection with a blood vessel or other body cavity, and a connection with a blood vessel or other body cavity.

[0138] The retraction unit has, for example, two retraction device holders having a distal end for extending through the opening to be closed and having a proximal end for selectively providing manipulation.

[0139] The engagement means is captured in a retractor holder to be released and positioned under the opening to be closed by manipulation. The manipulation of the retractor holder causes the opposite sides of the opening to be retracted, thereby causing the opening to change shape from a relatively round opening to a slit opening, the extended transverse diameter of the slit opening (i.e., the longer diameter of the retracted opening) being at least twice the length of the retracted longitudinal diameter of the opening (i.e., the shorter diameter).

[0140] 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 captured 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.

[0141] In some embodiments according to the present invention, a medical device comprises a set of retraction units.

[0142] In some embodiments according to the invention, the medical device comprises an indication to a user, the indication indicating the orientation or direction of the retraction unit of the medical device, for example the indication is implemented as a symbol, an arrow or the like.

[0143] 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.

[0144] In some embodiments according to the present invention, the retraction device holder comprises an elongated tube made of metal or plastic capable of capturing the retraction device.

[0145] In some embodiments according to the present invention, the retraction units can be moved apart to retract the opening.

[0146] 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 capturing the retraction device.

[0147] In some embodiments according to the invention, the closure device holder has a transverse passage at the end of the elongated tube through which the closure device will leave the closure device holder, thereby avoiding contact between the closure device and a structure opposite the end of the elongated tube.

[0148] In some embodiments according to the invention, the closure member may be manipulated to evenly distribute the closure means along the line to be closed.

[0149] 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.

[0150] In some embodiments, according to the present invention, the closure device has a predetermined cross-section, a proximal end, and two arms, each of which has 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 so that the arms return to the expanded second position, wherein the arms have a curved shape forming a ring having two hemi-circles or semi-circles.

[0151] In some embodiments according to the present invention, the closure device has a pre-set form that allows the closure device to be connected together with the closure device holder.

[0152] In some embodiments according to the present invention, the present invention is directed to a method for closing an opening in a wall, an incision, a puncture or other passage through tissue, a communication opening with a wall of a blood vessel or other body lumen, specifically but not exclusively a blood vessel having a lumen that carries blood.

[0153] The method comprises the following steps:

[0154] 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 diameter orthogonal to the long axis of the vessel, in preparation for connecting the expanded orthogonal sides of the opening;

[0155] b. One or more closure devices are inserted through the opening and uniformly deployed into the vessel lumen, the closure devices being manipulated to engage the vessel wall around the opening at the extended long sides between the shoulders of the opening and to connect the two expanded orthogonal sides of the retracted opening sides and close the opening.

[0156] In some embodiments according to the invention, the closing step comprises sewing, clamping or similar mechanical approximation of the engaged opening walls.

[0157] In some embodiments according to the present invention, the medical device for closing an opening includes the features disclosed herein in any combination unless it is 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 in light of the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0158] Figures 1A to 1D is a schematic side view of an embodiment of a retraction unit of a medical device according to the present invention;

[0159] FIG. 2A to FIG. 2F is a side view of an alternative embodiment of a retraction unit;

[0160] FIG. 3A to FIG. 3D is a schematic partial cutaway view of a retraction unit deployed within an opening;

[0161] 4A to 4D is a side view of an alternative embodiment of a retraction unit;

[0162] FIG. 5A to FIG. 5D is a schematic partially cut-away side view of a retraction unit deployed within an opening;

[0163] Fig. 6A and Figure 6B 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;

[0164] 7A to 7F is a side view of the closure device as shown in FIG. 6 , the closure device being deployed in the opening, penetrating the tissue and engaging the free edges of the opening;

[0165] 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;

[0166] Fig. 9 is a schematic perspective view of a closure member including a straight folded closure device captured in a closure device holder;

[0167] Fig.10 is a schematic partially broken longitudinal cross-sectional view of a closure member deployed within an opening in a vessel;

[0168] Fig.11 is a schematic partially broken longitudinal cross-sectional view of a closure member advanced into an opening in a vessel;

[0169] FIG. 12A to FIG. 12E yes Fig.10 a schematic partially cut-away longitudinal cross-sectional view of the closure member and the closure device shown in FIG. 6 deployed in an opening, penetrating tissue and engaging the free edges of the opening;

[0170] FIG. 13A to FIG. 13H yes Fig.10 6 is a schematic partially cut-away longitudinal cross-sectional view of an alternative closure member and a closure device deployed in an opening, penetrating tissue and connecting the free edges of the opening;

[0171] Fig.14 is a schematic partially cutaway perspective view of two retraction units advanced into an opening;

[0172] Fig.15 is a schematic partially cutaway perspective view of two retraction units deployed within an opening, FIG4 showing the advancement and deployment of two retraction devices within a vessel;

[0173] Fig.16 is a schematic partially cutaway perspective view of two retraction units deployed within an opening, FIG4 showing two retraction devices being advanced and deployed within a vessel, and the opening being retracted;

[0174] Fig.17is a schematic partially cutaway perspective view of two retraction units deployed within a stoma, FIG4 showing the two retraction devices being advanced and deployed within a vessel, the two retraction devices being retracted until a stop is felt, and the stoma expanding until the stoma becomes a straight slit and a stop can be felt;

[0175] Fig.18 is a schematic partially cutaway perspective view of two retraction devices and two closing devices deployed simultaneously or successively in an opening;

[0176] Fig.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 approached by the partially deployed closing devices shown in FIG. 6 ;

[0177] Fig. 20 is a schematic partially truncated perspective view of two retracting devices and two closing devices shown in FIG. 6 , wherein the two closing devices are fully deployed and connected to the long edges of the opening, and the retracting units are retracted successively;

[0178] Fig.21 is a schematic perspective view of the two closure devices shown in FIG. 6 being released, the closure devices closing the opening with transverse lines;

[0179] Fig. 22 is a schematic partially cutaway perspective view of two retraction devices and a closure member simultaneously advanced into an opening in a vessel;

[0180] Fig.23 is a schematic partially cutaway perspective view of two retraction devices and a closure member deployed within an opening in a vessel, the opening being retracted in a direction orthogonal to the long axis of the vessel;

[0181] Fig.24 is a schematic partially cutaway perspective view of two retraction devices and a closure member further advanced into an opening in a vessel, the opening being retracted in a direction orthogonal to the long axis of the vessel, and the long edges of the opening being approached and penetrated by the partially deployed closure device shown in FIG. 6 ;

[0182] Fig.25 is a schematic partially cutaway perspective view of a vessel with a closure device closing an opening;

[0183] FIG. 26A to FIG. 26G is a schematic partially cutaway stereoscopic view of seven steps (a to g) of the entire operation for closing a vascular stoma;

[0184] Fig. 27 An opening in a patient's vessel and its closure with a transverse surgical suture are shown;

[0185] Fig.28An opening in a patient's vessel and its closure using a crossover surgical procedure are shown;

[0186] Fig.29 An opening in a patient's vessel and its closure using longitudinal surgery are shown;

[0187] Fig.30 A closure device in an embodiment is shown in a perspective view;

[0188] Fig. 30A Shown in front view Fig.30 The closure device shown;

[0189] Fig.31 A closure device in another embodiment is shown in a front view;

[0190] Fig.31A Shown in stereogram Fig.31 The closure device shown;

[0191] Fig.32 A closure device in yet another embodiment is shown in a front view;

[0192] Fig.32A Shown in stereogram Fig.32 The closure device shown;

[0193] Fig.33 A portion of a medical device according to an embodiment of the present invention is shown in a perspective view;

[0194] Fig.33A Essentially shown from the front Fig.33 Medical equipment shown;

[0195] Fig.34 A portion of another embodiment of a medical device is shown in perspective view;

[0196] Fig.35 showing a portion of another embodiment of a medical device from the side; and

[0197] Fig.36 A highly simplified view of the front end surface of a medical device is shown.

[0198] Main component markings

[0199] 100: Retraction unit 101: Retraction device

[0200] 102: Retraction device holder 108: Arrow

[0201] 110: distal tip / distal end of the retraction device holder 111: proximal end

[0202] 112: Distal end 115: Guidewire lumen

[0203] 117: Sleeve 202: Suture / holding device

[0204] 203: Piston 204: Groove

[0205] 207: groove 301: blood vessel / vascular wall / tissue

[0206] 302: (vessel) opening / slit opening / aperture opening 410: engagement device

[0207] 420: bend / step 600: closure device

[0208] 602: proximal end / joint / groove 603: distal end of closure member / pointed end / tip of closure device / end of closure device

[0209] 604: Arm 605: Curled or bent section

[0210] 708: Anchor form of anchor / closure device 709: Tip 603 penetrates tissue wall

[0211] 722: 603 perforation 800: closing member

[0212] 801: Longitudinal direction arrow / indicator support / closing device 802: Closing device holder

[0213] Arrow for orientation of the holder

[0214] 803: Channel / lateral channel 804: Distal end / closure device holder end

[0215] 805: Proximal end / closure device holder end 1000: Guidewire

[0216] 1006: Vascular lumen 1411: Opening wall / edge

[0217] 1420: Arrow 1421: Move up

[0218] 1422: Angle 1722: Divider

[0219] 2204: Wall / opening wall / long side 2600: suture

[0220] 2700: Arrow L: longitudinal axis. DETAILED DESCRIPTION

[0221] Specific embodiments of the present invention relate to a vessel closing device and method for closing an opening in tissue, such as a vessel closing device including a tissue retraction unit and an opening closing component.

[0222] Tissue Retraction:

[0223] In one aspect of the present invention, a retraction unit is provided to retract two opposite parts of a tissue opening. After two arms, sides, etc. are deployed at opposite sides in the opening for closure, the distance between the arms, sides, etc. is increased to retract the opposite sides, thereby changing the shape of the tissue opening (opening) into a slit, wherein the two long straight sides of the opening are approached in preparation for closure.

[0224] 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 is intended to cause the opening in the tissue to become a transverse slit orthogonal to the long axis of the vessel, which is comparable to an open surgical transverse suture. As in an open surgical cross-stitching procedure or a longitudinal suture, circular retraction of the opening is prevented to avoid narrowing of the vessel being treated, see Fig. 27 .

[0225] Opening closure:

[0226] Another aspect of the present invention relates to a closure member for closing a tissue opening prepared using a retractor unit. It should be recognized that the retractor unit and the closure member can be used for general tissue repair and is not limited to vascular repair. It should be understood that throughout the following description, the closure device of the medical device can be formed of 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 clear from the description that the closure device preferably has the shape of a needle in the form of a loop or circle formed by a deformable shape memory alloy, such as 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 brings the ends of the opening close to and closes the perforation in the tissue.

[0227] After the opening in the tissue is prepared by the retraction device to form the slit, the two long sides of the slit are connected by the closing device to close the tissue opening.

[0228] FIG. 1 is a side view of a retraction unit 100 of the present invention. The retraction unit 100 optionally has a longitudinal hollow retraction device holder 102 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. 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, such as Nitinol, which is formed into a triangular shape in the expansion stage and can be compressed to be captured in the retraction device holder 102. When the retraction device holder 102 is retracted along the 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.

[0229] FIG. 2 is a side view of an alternative embodiment of the retraction unit 100 as shown in FIG. The retraction unit 100 has a longitudinal hollow retraction device holder 102 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, and the arms of the retraction device 101 are captured in the groove 207 and guided when the retraction device 101 moves 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 by, for example, a piston 203 captured in the retraction device holder 102 as required. The retraction device 101 is surrounded by an optional suture 202, which tethers the retraction device 101. The piston 203 has a groove 204 in cross section, and the suture 202 is captured in the groove 204. Figure 2C Towards Figure 2E When the piston 203 is pushed, the retraction device 101 is gradually released ( Figure 2C to Figure 2F ), and the distal end 112 gradually expands due to the memory effect of the retraction device 101. During the longitudinal pushing toward or pulling 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 acting assembly. 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, by pulling the two ends of the suture 202, the retraction device 101 can be removed from its position (opening).

[0230] FIG. 3 is a schematic, partially cut-away illustration of the retraction unit 100 deployed within a vessel opening 302 .

[0231] 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 with its distal end located within the lumen of a vessel 301 through an opening 302 to be closed.

[0232] The dimensions of the retraction unit 100 and retraction device 101 vary depending on the size of the opening 302 and the size of the vessel 301 or other body organ to be closed within the patient's body, as well as the material composition of the unit and device.

[0233] The retraction unit 100 having the retraction device holder 102 and capturing the retraction device 101 is inserted into the opening 302 of the vessel 301. Once the distal end 110 of the retraction device 101 is deployed below the vessel wall opening 302, the retraction device holder 102 is gradually retracted in a direction away from the vessel opening 302 (from Figures 3A to 3D ), 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 vessel to the longitudinal axis of the vessel. Figure 3B Expand to Figure 3D And the vessel wall 301 becomes Figure 3D The slit opening 302 in the.

[0234] FIG4 is a side view of an alternative embodiment of the retraction unit 100 shown in FIG1 . 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, with an optional engagement device 410 at each of the two distal ends 112. The engagement device 410 is preferably a loop-like element, preferably a wire loop, which is initially formed into 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 having a memory effect (such as a memory alloy, such as 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 FIG. 4B to FIG. 4D ), 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 unfolds.

[0235] FIG. 5 is a schematic, partially cut-away side view of the retraction unit 100 deployed within an opening 302 of a vessel 301 .

[0236] 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 with its distal end located within the lumen of a vessel 301 through an opening 302 to be closed.

[0237] The dimensions of the retraction unit 100 and retraction device 101 vary depending on the size of the opening 302 and the size of the vessel 301 or other body organ to be closed within the patient's body, as well as the material composition of the unit and device.

[0238] The retraction unit 100 having a retraction device holder 102 and capturing a retraction device 101 is inserted into an opening 302 of a 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 captured in the retraction device holder 102. Once the distal end 110 of the retraction device holder 102 is deployed under the vessel wall opening 302, the retraction device holder 102 is gradually retracted in a direction away from the vessel opening 302 (from FIG. 5A to FIG. 5B ), thereby releasing the engagement device 410 ( Figure 5D ), the engagement device 410 is deployed below the vessel opening 302 and engages the vessel inner wall around the opening. Figure 5B was further released to Figure 5C Due to the memory property of the engagement device 410, the opening 302 is gradually expanded (from FIG. 5B to FIG. 5D ) and becomes a slit opening 302 in the vessel wall 301 ( Figure 5D When the vessel opening 302 is in the shape of a slit, the deployed engagement device 410 prevents the engagement device 410 from retracting out of the vessel opening 302.

[0239] 6 is a front view of a closure device 600 of the present invention in the preferred form of a round needle. The closure device 600 has a proximal end 602 and first and second arms 604, each of which optionally has a pointed distal end 603. The two arms 604 are curved portions of the closure device 600.

[0240] The closure device 600 has: an expanded substantially closed position ( Fig. 6A ), wherein the two arms 604 each form a semicircle in a desired or substantially one plane, thereby allowing the two arms 604 to cross each other; and a compressed substantially closed position ( Figure 6B ), wherein the arms 604 are substantially linear, thereby allowing the closure device 600 to be captured in the retraction device holder 102 (Figure 5) or the closure member 800.

[0241] The closure device 600 may be made from a variety of preset memory shape materials, wherein the material selection depends on the specific needs.

[0242] The closure device 600 can be formed of any biocompatible material, including, for example, titanium (and titanium alloys), nitinol, stainless steel, polymeric materials (synthetic and / or natural), ceramics, etc. and / or bioabsorbable materials, for example, galvanic corrosion can be used. The decomposition rate can be adjusted by a composition that does not form any macroscopic bubbles. 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 required size of use. Depending on the application, the closure device 600 can have a size and cross-sectional size 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.

[0243] Preferably, the expanded loop-forming closure device 600 ( Fig. 6A ) can be elastically compressed into its compressed state ( Figure 6B ), for example, by using the closure member 800 to constrain the closure device 600, such as Figure 8 shown.

[0244] The closure device 600 can be moved from a retracted state ( Figure 6B ) is deployed to Fig. 6A 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 looped closure device 600 perforates the wall, and further withdrawal can be detected by an increase in resistance to further withdrawal (e.g., Fig.13F shown).

[0245] 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 hole 302, and the anchor-like curved arm 604 will approach the perforated tissue wall, as shown in FIG7. Figure 6B The groove 602 of the proximal end 602 of the closure device 600 (see Fig. 6A ) allows locking of the closure device 600 to the closure member 800, as shown in FIG. 13 below.

[0246] FIG. 7 is a side view of the closure device 600 shown in FIG. 6 , the closure device 600 being deployed in the opening 302 , penetrating the tissue 301 , and connecting the free edges of the opening 302 .

[0247] FIG. 7 shows the subsequent deployment of the closure device 600 shown in FIG. 6 in the opening 302 to be closed.

[0248] exist Fig. 7A In the embodiment shown in FIG. 6 , the closure device 600 (shown in FIG. 6 ) is in a compressed straight configuration and is advanced within the opening 302 of the tissue 301 .

[0249] exist Figure 7B In FIG. 6 , the closure device 600 is partially deployed and the tip 603 of the closure device is bent due to the memory material effect.

[0250] exist Figure 7C As the closure device 600 is further deployed, the end 603 of the closure device further bends into an anchor form 708, wherein the pointed end 603 of the closure device engages a side of the tissue opening 301 and penetrates (see 709) the wall 301.

[0251] 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 of the tissue.

[0252] However, it should be understood that deployment of the closure device 600 may require the use of the closure device holder 802 as described later. Figure 8 12. It should be appreciated that more closure devices 600 may be utilized depending on the embodiment of the closure device 600 and the organization thereof.

[0253] Figure 8 is a schematic truncated side view of a closure member 800 in a longitudinal direction 801, the closure member 800 consisting of a longitudinal hollow closure device holder 802 having a distal end 804. The closure device holder 802 accommodates a straight compressed closure device 600. The closure device holder 802 optionally has a transverse channel 803 for deploying the closure device 600.

[0254] Fig. 9 Yes Figure 8 A schematic truncated perspective side view of a closure device holder 802 indicated by arrow 801 is shown, the closure device holder 802 accommodating 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 ( Fig. 12C ) exit the closure device holder 802 in a curved manner, such as FIG. 12B to FIG. 12D As shown, however, the closure device 600 is prevented from engaging structures and tissues (such as opposing vascular arms) that may be positioned opposite the end 804 of the closure device holder 802.

[0255] Fig.10 is the vessel 301 and Figure 8 and Fig. 9 Schematic partially cutaway perspective view of a closure device holder 802 indicated by arrow 801, which receives a straight folded closure device 600 and is advanced through an opening 302 in a vessel wall 301 into a 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 ( Fig. 12C Chinese) FIG. 12B to FIG. 12D The curved pattern shown exits the closure device holder 102, thereby preventing the closure device from engaging the opposing vessel wall 301.

[0256] Fig.11 is the vessel 301 and Figure 8 , Fig. 9 and Fig.10 Schematic partially cutaway perspective view of a longitudinal cross section of a closure device holder 802 indicated by arrow 801, the closure device holder 802 receiving a straight compressed closure device 600 and deployed in the vessel lumen 1006 through the opening 302 in the vessel wall 301. The channel 803 in the distal closure device holder 802 allows the closure device 600 to be deployed, for example, with an anchor 708 ( Fig. 12C In the form of FIG. 12B to FIG. 12D The curved pattern shown exits the closure device holder 102, thereby preventing the closure device from engaging the opposing vessel wall 301.

[0257] Figure 12 is Figure 8 and Fig. 9 A schematic partially cut-away longitudinal cross-sectional view of a closure device holder 802 indicated by arrow 801 is shown. FIG. 12A to FIG. 12E The sequence is shown in Figure 8 The closure device holder 802 is shown deployed in Fig. 12A in the opening shown.

[0258] exist Fig. 12B 804 of the closure device holder 802 and the tip 603 of the closure device bends and leaves the closure device holder 802 in the channel 803.

[0259] exist Fig. 12C 8. In the embodiment shown in FIG. 8, the closure device 600 is further pushed in the direction of the end 804 of the closure device holder 802, thereby further exiting the closure device holder 802 through the passage 803 and optionally forming the anchor 708. The tip 603 of the closure device 600 engages the vessel wall 301.

[0260] exist Fig.12D6 , the closure device holder 802 is further withdrawn from the opening 302. The anchor 708 has a pointed end that 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 inwardly, thereby drawing the ends of the opening 302 together to close the opening 302 and form a ring structure as shown in FIG6 .

[0261] FIG. 13 is a schematic partially broken longitudinal cross-sectional view of an alternative closure member 800 deployed in an opening 302 in the wall of a vessel 301. FIG. 13C to FIG. 13H The sequence of FIG. 8 shows the deployment of the closure device 600 and the closure of the opening 302 achieved by the closure device 600. In this embodiment, the closure member 800 captures the piston 203.

[0262] Fig.13A A piston 203 is shown in cross section, having a groove 204 in which a retaining device 202, preferably a suture, is guided. The retaining device 202 is tethered to the closing device 600 in order to connect the piston 203 and the closing device 600 together.

[0263] Fig. 13B Shown as Figure 8 The cross section of the closure device holder 802 shown has a groove 207 in which the arms of the closure device 600 are captured 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 toward the end 804 of the closure device holder 802 by the piston 203, as shown in FIG. FIG. 13C to FIG. 13H shown in the sequence.

[0264] exist Fig. 13C In the embodiment, the end of the closure member 800 is disposed in the opening 302 in the wall of the vessel 301. The closure member 800 and the closure device 600 are oriented in the longitudinal direction of the vessel 301, such as Figure 8 As shown by arrow 801.

[0265] exist Fig.13D In the embodiment of the present invention, 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.

[0266] exist Fig.13E7 , 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.

[0267] exist Fig.13F In the embodiment, the closure device holder 802 is withdrawn with the closure device 600 and the pointed end 603 of the partially released closure device 600 formed like the 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.

[0268] 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 semicircle, thereby bringing the tissue opening ends close to and closing the opening 302, somewhat like a single structure for closing the opening 302, such as Fig.13H shown.

[0269] 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 localize or even retract the closure device 600 if necessary. When the closure result of the opening 302 is satisfactory, the holding device 202 is removed, for example, by pulling one of the arms of the holding device 202.

[0270] The following description combines the retraction unit 100 and the closing member 800 in one set or one medical device, which are deployed simultaneously or one after the other. Figures 14 to 21 The sequence shows the closing of the opening 302 using two closing members 800 .

[0271] Fig.14 is a schematic partially broken perspective view of an alternative embodiment of the retraction unit 100 as shown in Fig. 5. The retraction unit 100 has two retraction device holders 102, each of which captures one retraction device 101 with an engagement device 410 connected distally.

[0272] The engagement device 410 is preferably a wire loop that can be folded and captured in the retraction device holder 102.

[0273] The distal ends 110 of the two retraction device holders 102 are deployed in opposite sides of the opening 302 in the tissue 301 .

[0274] Fig.15is 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 left the opening at the distal end 110 of the retraction device holder 102, and the engagement device 410 has been deployed into a loop.

[0275] Fig.16 is a schematic partially cutaway perspective view of two retraction units 100 in an aperture opening 302, with distal 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.

[0276] Fig.17 1 is a schematic partially cutaway perspective view of two retraction devices 101 deployed in a pore opening 302, wherein the distal ends 110 are 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 stop when the opening of the pore 302 forms a straight slit, for example, wherein the length of the slit is equal to 1 / 400 mm. Fig.15 The engagement member 410 forms a circle having a diameter greater than the minor axis of the slit opening of the aperture 302, the minor axis being at an angle 1422 of 90 degrees to the slit opening. The engagement member 410 will lock out unintentional upward movement 1421 of the retraction unit as indicated by arrow 1420. When the engagement member 410 contacts and cannot pass through the slit opening of the aperture 302, the upward movement 1421 of the retraction device 101 is stopped.

[0277] Fig.18 Yes Fig.16 Schematic partially cutaway perspective view of two retraction devices 101 and two engagement devices 410 deployed in a stoma opening 302, which has transformed the stoma into a slit form with simultaneous or sequential deployment of a closure member 800, wherein two closure device holders 802 are located between the stoma shoulders, and the end 804 and channel 803 are positioned below the opening of the stoma 302. The closure device 600 is captured and compressed in the closure device holder 802 and is oriented at a 90 degree angle to the stoma opening 302, as indicated by the divider 1722 and arrow 801.

[0278] Fig.19 is a schematic partially cutaway perspective view of two retraction devices 101, wherein the engagement device 410 and the closing device holder 802 are shown as Fig.18803, and the closure device 600 is further withdrawn from the vascular ostium 302.

[0279] Fig. 20 4 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. Fig.19 The closure device holder 802 is shown removed. Fig.19 The closure device 600 is shown fully expanded to form a Fig. 6A The closure device 600 actually makes the free edge 1411 of the opening 302 close and close.

[0280] Fig.21 is a schematic perspective view of tissue 301 with opening 302 closed. The sides of opening 302 have been approximated and closed by closure device 600 which perforates the tissue as indicated by perforations 722.

[0281] The following description combines the retraction unit 100 and the closure member 800 in one set or one medical device, which are deployed simultaneously in the vessel 301. Figure 22 to Figure 25 The sequence shows the closure of an opening 302 in tissue using a closure device 600.

[0282] Fig. 22 is 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 in an opening 302 in a wall 2204 of the vessel 302. The engagement device 410 is positioned inside the vessel lumen 1006, oriented in the longitudinal direction of the vessel 301, as indicated by arrow 801. At the same time, the closure device retainer 802 is deployed between the retraction devices 101, wherein the opening of the passage 803 is located inside the vessel lumen 1006 below the opening wall 2204, oriented in the longitudinal direction of the vessel 301, as indicated by arrow 801.

[0283] Fig.232 is a schematic partially cutaway perspective view of two retraction devices 101, wherein engagement devices 410 and one closure device holder 802 are deployed in the wall 2204 of the vessel 302 in the opening 302. The engagement devices 410 and the channel 803 of the retraction device holder 102 are positioned inside the vessel lumen 1006 below the opening wall 2204. 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 is pressed against the inner wall of the vessel 301 in opposite directions. This will retract the opposite sides of the opening 302 and expand the opening 302 of the vessel 301 in a direction orthogonal to the long axis of the vessel 301, while bringing the expanded two opposite long sides of the opening 302 close together.

[0284] Fig.24 is a schematic partially cutaway perspective view of two retraction devices 101 with engagement devices 410 and one closure device holder 802 deployed in the wall 2204 of the vessel 301 in the opening 302. The engagement devices 410 and the channel 803 of the retraction devices 101 are positioned inside the vessel lumen 1006 below the opening wall 2204. The retraction devices 101 and engagement devices 410 have retracted the opening 302 in a direction orthogonal to the long axis of the vessel 301, thereby approximating the two opposite long sides of the expansion of the opening 302. The closure device 600 is partially deployed, has exited the closure device holder 802 by the channel 803 and has formed an anchor 708, which has fully grasped and penetrated the vessel wall 2204, as indicated by the perforations 722. Further withdrawal can be detected by firm resistance to further withdrawal. Then, the closure device holder 802 is further retracted from the vascular opening 302, and the closure device 600 is released, thereby forming a complete circular structure to pull the opening wall 2204 and further close the two opposite long 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 closed opening 302 while the flexible ring of the engagement device 410 collapses and slides through the shoulder of the closed opening 302.

[0285] Fig.25 3 is a schematic partially cutaway perspective view of a vessel 301 having an opening 302, the opening 302 having been closed by a closing device 600 that perforates 722 the opening wall 2204 to form a straight line orthogonal to the long axis of the vessel.

[0286] FIG. 26 is a schematic, partially cut-away view from the operator's perspective illustrating the closure of an opening 302 in a patient's vessel.

[0287] exist Fig.26BIn FIG. 8 , a retraction unit 100 having two arms and a closure member 800 having three closure device holders 802 are deployed in an opening 302 of a patient's vessel.

[0288] exist Fig.26C In the embodiment, the engagement device 410 is moved apart at opposite sides of the opening 302 in a lateral direction orthogonal to the long axis of the vessel, so that the sides of the opening 302 are retracted, which makes the upper and lower ends of the opening 302 approach and form a slit opening with two long sides (i.e., the distal side and the proximal side) and two short sides (at the lateral sides of the vessel). At the same time, the closure device holders 802 are moved apart to be evenly spaced along the expanded opening 302.

[0289] exist Fig.26D In the embodiment of the present invention, the closure devices 600 are deployed and each forms an anchor.

[0290] exist Fig.26E In the embodiment of the present invention, the closure device holder 802 is retracted and the closure device 600 engages the wall of the vessel 301 around the opening 302 and perforates the wall after the closure device holder 802 is further retracted.

[0291] Further withdrawal can be detected by 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.

[0292] exist Fig.26F In the embodiment of the present invention, the closing device 600 is deployed to form a circular needle for closing the opening 302.

[0293] exist Figure 26G The closing device 600 closes the transverse seam of the opening 302.

[0294] Fig. 27 2 is a surgeon's view of an opening 302 in a patient's vessel 301, showing the open surgical closure of the opening 302 using sutures. The opening 302 in the patient's vessel 301 is closed in a straight line orthogonal to the long axis of the vessel using continuous or interrupted sutures 2600 to avoid stenosis of the patient's vessel. This principle of closure of the opening in the patient's vessel is particularly important and is used in the present invention as shown in FIG. Fig.10 To Figure 12 and Fig. 22 26, which illustrate exemplary methods of operating a medical device.

[0295] Fig.282 is a surgeon's view of an opening 302 in a patient's vessel 301 showing open surgical closure of the opening 302 using sutures 2600. The opening 302 in the patient's 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.

[0296] Fig.29 2 is a surgeon's view of an opening 302 in a patient's vessel 301, showing the open surgical closure of the opening 302 using sutures 2600. The opening 302 in the patient's vessel 301 is closed using longitudinal sutures. The approximation of the lateral sides of the opening 302 narrows the vessel lumen, as indicated by arrows 2700.

[0297] Only like Fig. 27 , Fig.10 12 and 12 to 26, the lateral closure orthogonal to the long axis of the vessel will bring the proximal and distal ends of the opening 302 closer and simultaneously expand the lateral sides of the opening 302, thereby avoiding narrowing of the vessel diameter and lumen.

[0298] Fig.30 The closure device 600 in an embodiment is shown in a perspective view. The closure device 600 comprises two arms 604, each of which carries an optionally pointed end 603. The arms extend from a curled or bent section 605.

[0299] Fig. 30A Shown in front view Fig.30 Closure device 600 is shown.

[0300] Fig.31 A closure device 600 in a further embodiment is shown in front view. The closure device 600 comprises two arms 604, each of which carries an optionally pointed end 603. No curled or bent sections are provided.

[0301] Fig.31A Shown in stereogram Fig.31 Closure device 600 is shown.

[0302] Fig.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. Fig.30 In contrast to the illustrated embodiment, the curled or curved section 605 is not closed, meaning that there is no helical section.

[0303] Fig.32A Shown in stereogram Fig.32Closure device 600 is shown.

[0304] Fig.33 Parts of a medical device according to the invention are shown in a perspective view. A guidewire 1000 is introduced into the lumen 1006 of the vessel 301. The guidewire 1000 continues through a central opening of the medical device, which continues and is indicated as guidewire lumen 115.

[0305] The two engaging devices 410 shrink the opening 302 into a slit.

[0306] Fig.33 If a retraction unit is shown, it can be arranged so that it can be advanced through the guidewire lumen 115, such as Fig.35 Another embodiment of a medical device is shown in FIG.

[0307] Although not shown in the figures, the medical device and in particular the engagement device 410 or the retraction device 101 may include a segment that prevents the guidewire 1000 from interfering with the closure device. The segment may be a wire structure that guides the guidewire out of the range of the closure device 600.

[0308] Fig.33A Shown from the front Fig.33 Medical equipment shown.

[0309] Fig.34 Parts of another embodiment of the medical device are shown in a perspective view. The engagement device 410 is constructed from a single wire. Fig.34 It can be seen that the retraction device 101 or any other part of the medical device that is inserted into the lumen of the vessel in use may include a step or bend 420 in any embodiment, which may interact with the wall of the opening 302 or the vessel 301 so that the step or bend 420 gives tactile feedback to the surgeon when the medical device is pulled out of the vessel 301 again. When the surgeon feels the tactile feedback, he knows that the medical device is ideally placed relative to the opening 302 to close the opening 302 by releasing the closing device 600.

[0310] Fig.35 Parts of a further embodiment of a medical device are shown from the side. Fig.35 In fact, it is shown in Fig.33 or Fig.33A However, Fig.35 Also shown in a highly schematic manner are two closing devices 600 which close the opening 302. The engaging device 410 still has to be folded again and withdrawn from the vessel lumen 1006.

[0311] Fig.36A highly simplified view of the front end surface of a medical device with a longitudinal axis L and a cannula 117 in yet another embodiment is shown. As can be seen, the end of the medical device has several openings. One opening accommodates a guidewire 1000, one opening accommodates two retraction devices 101, and one opening accommodates four closure devices 600.

[0312] It goes without saying that the number of openings, retraction devices 101 and closing devices 600 is not limited to Fig.36 In addition, the guidewire 1000 may continue through an opening dedicated to the guidewire 1000. However, the guidewire 1000 may also share its opening with one or more retraction devices 101 and / or closure devices 600.

[0313] It should be understood by those skilled in the art that although this description is made for preferred embodiments, the invention and this description are in many respects illustrative and non-restrictive, and are susceptible to various modifications and alternative forms. Changes may be made in details, specifically in the shape, size, material and arrangement of parts, without exceeding the scope of the invention. However, it should be understood that the invention is not limited to the specific form or method disclosed, but on the contrary, the invention will cover all modifications, equivalent forms and alternatives.

[0314] Therefore, the scope of the invention is defined in the following claims.

Claims

1. A medical device for closing an opening (302), incision, puncture, passage through tissue and / or a connection with a blood vessel or other body cavity in a patient's tissue (301), characterized in that: The medical equipment includes one or more closure device holders (802) having a distal end (804) for extending through the opening (302) to be closed and for releasably receiving one or more closure devices (600) designed as staples or clips; as well as A retraction unit (100) for contacting opposite sides of the opening (302) and for retracting the opposite sides and for expanding the opening (302) to change the shape of the opening (302) into a slit or an opening (302) that is like a slit or more like a slit, 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); The distal end (804) of the closure device holder (802) has two or more channels (803) on the wall of the closure device holder (802), the channels allowing at least one end of the closure device (600) to exit the closure device holder (802) when manipulating the medical device or when requested by the user; The retraction unit (100) comprises: at least one retraction device holder (102); at least one retraction device (101); and at least one engagement device (410) connected to the retraction device (101); and At least one of the engagement means (410) and the retraction means (101) is configured for releasably engaging tissue surrounding the stoma from within or from below the stoma opening.

2. The medical device according to claim 1, wherein the retraction unit (100) comprises: at least one retraction device holder (102); as well as at least one retraction device (101), at least partially received in the retraction device holder (102), wherein the retraction device (101) is at least partially releasably received in the retraction device holder (102); The retraction device (101) is arranged in a movable or slidable manner relative to the retraction device holder (102).

3. The medical device of claim 1, wherein the engagement means (410) is configured to be foldable and / or to be at least partially contained or captured within the retraction device holder (102).

4. The medical device of claim 3, wherein at least two retraction means (101) and / or at least two engagement means (410) are releasably captured within the retraction means holder (102).

5. The medical device of claim 1, wherein the retraction device holder (102) and / or the retraction device (101) and / or the engagement device (410) are configured to retract the opposite sides of the opening (302).

6. The medical device according to claim 1 or 2, wherein the retraction unit (100) comprises at least The retraction device (101) has at least one of the following: a first side and an opposite second side, The first and second arms, A first retracting device (101) and a second retracting device (101), a first retracting device holder (102) and a second retracting device holder (102), and A first meshing device (410) and a second meshing device (410); as well as 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 (101) away from or away from the second retraction device (101), moving the first retraction device holder (102) away from or away from the second retraction device holder (102) and / or moving the first engagement device (410) away from or away from the second engagement device (410).

7. The medical device of claim 6, wherein the mechanism comprises or consists of shape memory properties.

8. The medical device according to claim 1 or 2, comprising: The closure device (600) is contained in the closure device holder (802).

9. The medical apparatus of claim 1 or 2, wherein the closure device (600) is at least partially contained within the closure device holder (802) in a stressed state.

10. The medical device of claim 9, wherein the closure device (600) is contained within the closure device holder (802) such that when the closure device (600) is manipulated to withdraw from the distal end (804) of the closure device holder (802) during use of the medical device, the closure device (600) releases its stress or a portion of its stress by bending two or more arms (604) outward from the closure device holder (802), thereby causing two or more ends (603) to be arranged to perforate the inner wall (301) of the tissue surrounding the opening (302).

11. The medical device of claim 1, wherein at least a portion of the closure device (600), the retraction device (101), the retraction device holder (102) and / or the engagement device (410) is made of a deformable shape memory alloy and / or has a self-expanding shape memory segment or wire body.

12. The medical device of claim 1, wherein at least a portion of the closure device (600), the retraction device (101), the retraction device holder (102) and / or the engagement device (410) is made of Nitinol.

13. The medical device of claim 1, wherein at least a portion of the closure device (600), the retraction device (101), the retraction device holder (102) and / or the engagement device (410) are made of a biocompatible and / or bioabsorbable material.

14. The medical device of claim 13, wherein the biocompatible and / or bioabsorbable material is at least one material selected from the group consisting of: Ti, Ti alloy, Nitinol, stainless steel, polymeric material, and ceramic.

15. The medical device of claim 1 or 2, wherein the closure device (600) or a portion thereof is curled into a closed form when in an unstressed state.

16. The medical device of claim 1 or 2, wherein the closure device (600) or a portion thereof is curled into a loop or ring or circular shape when in an unstressed state.

17. The medical device of claim 1 or 2, wherein after deployment, the closure device (600) has a cross-sectional dimension ranging from 10 microns to 1 centimeter, from 40 microns to 200 microns, or from 50 microns to 100 microns.

18. The medical device of claim 1 or 2, further comprising a pushing device extending through a proximal end (805) of the closing device holder (802) for manipulating the closing device (600).

19. The medical device of claim 18, wherein the pushing means is a rod or a piston (203).

20. The medical device of claim 18, further comprising a holding device (202) extending through the proximal end of the closure device holder (802) for manipulating the closure device (600), wherein the holding device (202) is attached to the closure device (600).

21. The medical device of claim 20, wherein the retaining means (202) is a string or a suture.

22. The medical device of claim 20, wherein the closing device holder (802) has one or more grooves (207) on an inner wall of the closing device holder (802) and / or one or more grooves (204) on the pushing device for guiding the holding device (202) along a longitudinal direction of the closing device holder (802).

23. The medical device of claim 22, wherein the distal end (804) of the closure device holder (802) has at least one channel (803) or two channels (803) arranged opposite to each other on the inner wall of the closure device holder (802).

24. The medical apparatus of claim 2, wherein the retraction device holder (102) comprises an elongated tube comprising or consisting of metal or plastic configured to capture the retraction device (101).

25. A medical device as claimed in claim 4, wherein the at least two retraction devices (101) and / or the at least two engagement devices (410) are arranged to be at least partially released from the retraction device holder (102) by manipulating the retraction device holder (102) or the engagement device (410) to be positioned below the opening level of the opening (302) to be closed.

26. The medical device of claim 5, wherein the opening (302) changes its shape into a slit opening such that an extended transverse diameter of the opening (302) is at least twice as long as a retracted longitudinal diameter.

27. The medical device of claim 9, wherein the closure device (600) is at least partially contained within a distal end (804) of the closure device holder (802) in a stressed state when the medical device is in an undeployed state.

28. The medical device of claim 9, wherein the closure device (600) has two or more ends (603) and a joint (602) connected to the two or more ends (603) via two or more arms (604).

Images