Percutaneous perforation closure systems, devices, and methods

A device for sealing an aperture in a tissue includes: an implant configured to seal the aperture when positioned adjacent to the aperture; and a delivery shaft configured to engage the implant to allow the implant to be maneuvered into sealing engagement with a distal surface of the tissue, the delivery shaft comprising a retaining sleeve comprising a locking projection engagable with the locking recess of the implant to secure the implant to the delivery shaft, and a release sleeve axially slideable relative to the retaining sleeve between a first axial position in which the release sleeve is configured to maintain locking engagement between the locking recess and the locking projection, and a second axial position in which the release sleeve permits the locking projection to disengage the locking recess.

TECHNICAL FIELD

The present invention relates generally to closure systems, devices, and methods for use in surgical procedures.

BACKGROUND

Minimally invasive procedures are continually increasing in number and variation in part because such techniques offer an immediate advantage over more traditional, yet highly invasive surgeries. Endoscopic surgery, for example, uses one or more scopes inserted through small incisions for diagnosing and treating disease. In particular, endovascular surgery gives access to many regions of the body, such as the heart, through major blood vessels. Typically, the technique involves introducing a surgical instrument percutaneously into a blood vessel, such as, for example, the femoral artery. The currently emerging percutaneous endovascular procedures include aortic valve replacement, mitral valve repair, abdominal and thoracic aneurysm repair and tricuspid valve replacement. Other procedures requiring access to the femoral artery include coronary, carotid and cerebral angiographic procedures.

Other examples of a minimally invasive procedure include NOTES (Natural Orifice Translumenal Endoscopic Surgery) based surgery, e.g. transgastric, transvesical, and transcolonic approaches.

A key feature of these minimally invasive surgical procedures is the forming of a temporary pathway, usually an incision or dilated perforation, to the surgical site. For example, in the emerging percutaneous endovascular procedures, an access site (e.g. incision, puncture hole, or perforation) ranging from approximately 10 to 30 French units is formed as a temporary pathway to access the target site. Various instruments, such as procedural sheaths, guidewires and catheters, are inserted through the access site, as well as specialized medical instruments, such as, balloon catheters and stents.

Currently, these large (10 to 30 French (F)) puncture holes (or perforations) or access sites are routinely created after surgical cut down to the blood vessel and post procedure are closed via cut-down surgical repair. This method is very invasive and fraught with complications. Accordingly, the rapid development of percutaneous endovascular surgery, of which interventional radiology and cardiology are a major component, has led to the need for instrumentation to minimize the risk of complications associated with closing the access site after a procedure.

SUMMARY

In accordance with example embodiments, a device for sealing an aperture in a tissue includes: (a) an implant configured to seal the aperture when positioned adjacent to the aperture; and (b) a delivery shaft configured to engage the implant to allow the implant to be maneuvered into sealing engagement with a distal surface of the tissue, the delivery shaft comprising: (i) a retaining sleeve comprising a locking projection engagable with the locking recess of the implant to secure the implant to the delivery shaft, and (ii) a release sleeve axially slideable relative to the retaining sleeve between a first axial position in which the release sleeve is configured to maintain locking engagement between the locking recess of the implant and the locking projection of the retaining sleeve, and a second axial position in which the release sleeve permits the locking projection of the retaining sleeve to disengage the locking recess of the implant.

The release sleeve may include an interlocking projection configured to engage an interlocking recess of the implant when the release sleeve is in the first axial position and to disengage the interlocking recess when the release sleeve is moved from the first axial position to the second axial position.

The interlocking projection may be one of plurality of interlocking projections configured to engage a respective plurality of interlocking recesses of the implant.

The projection may be biased toward a flared position such that movement of the release sleeve from the first axial position to the second axial position causes the interlocking projection to flare away from and out of engagement with the interlocking recess of the implant.

The device may further include: a handle coupled to the delivery shaft; and an actuator moveable between a first position and second position relative to the handle, wherein the device is configured such that (a) movement of the actuator from the first position to the second position causes a change in the position of two components of the implant relative to each other and (b) movement of the actuator from the second position to the first position causes the delivery shaft to release the implant.

The implant may be formed of a polymer adapted to remain shelf stable and functional for sealing after terminal sterilization.

The polymer may be adapted to remain shelf stable and functional for sealing after terminal sterilization using at least one of (a) ethylene oxide, (b) electron-beam, (c) gamma irradiation, and (d) nitrous oxide.

The polymer may be biodegradable.

The polymer may comprise polydioxanone.

The device may be configured to seal a perforation in a hollow vessel.

The implant may include an intraluminal portion configured to form a seal with the perforation by contacting an intraluminal surface of the hollow vessel.

The implant may include an extra-luminal portion configured to extend outside the hollow vessel, the delivery shaft being configured to engage the implant via the extra-luminal portion.

The implant may include a flexible wing extending outwardly from a base portion.

The device may be configured to be guided over a guidewire.

The implant may be formed at least in part of a material having an inherent viscosity in a range from 0.5 to 7.0 dl/g.

The implant may include a flexible wing having a diameter greater than a diameter of the aperture in the tissue.

The implant may include a distal foot portion, a flexible wing, and a recessed surface disposed in the distal foot portion and into which the flexible wing is positioned and crimped to provide an effective fluid seal between the foot portion and the flexible wing.

The crimping may be achieved using at least one of (a) mechanical, (b) chemical, and (c) thermal methods.

The implant may include: a flexible wing; and a foot including a distal portion configured to be disposed distally of the flexible wing when the implant is positioned to seal the aperture and a proximal neck configured to extend away from the aperture and proximally away from the aperture.

The distal portion of the foot may have a length this is greater than a diameter of the aperture.

The proximal neck may be flexible relative to the distal portion of the foot.

The proximal neck may extend distally along an axis relative to an upper surface of the distal portion of the foot at an angle that is within the range from 10° to 70°.

The distal portion of the foot may be configured to reinforce the flexible wing to facility sealing of the aperture.

The implant may include a base portion and a pin moveable relative to the base portion between a first position and a second position, wherein the pin in the second position is configured to extend outwardly from the base to provide a safety against the base being fully pushed or pulled distally through the aperture to be sealed.

The implant may include a guide channel configured to receive a guide wire.

The pin may be configured to block the guide channel when the pin is in the second position.

The pin may be configured to leave the guide channel open when the pin is the second position.

The base may include a cavity configured to allow sealing of the guide channel via coagulation after removal of a guidewire from the guide channel.

The device may further include: a loading funnel configured to fold the implant into an elongated folded configuration to permit the wing to pass through a procedural sheath when the delivery shaft maneuvers the implant into a location of the aperture to be sealed.

The loading funnel may include: a tapered portion configured to progressively fold the implant into the folded configuration when the implant is maneuvered through the tapered portion in a proximal direction; and a narrowed portion configured to receive the implant with the flexible wing in the folded configuration when the implant is maneuvered further in the proximal direction and proximally beyond the tapered portion.

The tapered portion may include a frustoconical conical portion and the narrowed portion comprises a cylindrical portion.

The frustoconical portion and the cylindrical portion may be non-concentric.

The narrowed portion may include a cannula configured receive the implant with the wing in the folded configuration and that can be detached from the remainder of the loading funnel.

The device may further include a packaging having a proximal and a distal end, wherein: the delivery shaft, the implant, and the loading funnel are disposed in the packaging such that the delivery shaft extends distally through the narrowed portion of the funnel and into the tapered portion, where the delivery shaft is coupled to the implant; and the loading funnel is held in the packaging such that proximal movement of the delivery shaft relative to the package causes, sequentially, (a) proximal movement of the implant through the tapered portion to progressively fold the implant into the folded configuration, (b) proximal movement of the implant into the cannula, and (c) separation of the cannula, with the implant disposed therein, from the remainder of the loading funnel.

The implant may be held in the tapered portion by the delivery shaft a location.

The device may further include a handle coupled to the delivery shaft.

The cannula may be configured to access multiple forms of introducer sheaths.

In accordance with example embodiments, a method of using the device includes: loading the implant in to the cannula at the time of a surgery in which the implant is used; and inserting the cannula into a proximal access of a procedural sheath in order to introduce the implant in the folded configuration into the procedural sheath.

The method may further include feeding a proximal end of the guidewire through the implant and the delivery shaft prior to inserting the cannula into the proximal access of the procedural sheath, such that the distal end of the guidewire extends through the aperture to be closed by the implant.

In accordance with example embodiments, a device includes: a sealing member configured to seal the aperture when positioned adjacent to the aperture; and a delivery device releasably coupleable to the sealing member such that the delivery device is configured to position the sealing member adjacent to the aperture, wherein the sealing member comprises a passageway configured to receive a guidewire to guide the sealing member to the aperture, the sealing member configured to seal the passageway after complete removal of the guidewire from the passageway.

The sealing member may include a base portion and a moveable member that is moveable between a first position and a second position relative to the base portion.

The sealing member may be configured such that movement of the moveable member from the first position to the second position causes occlusion of the passageway in order to seal the passageway after removal of the guidewire from the passageway.

The delivery device may be configured to move the moveable member from the first position to the second position.

In one aspect of example embodiments of the invention, an implantable device for sealing a surgical perforation is provided. In accordance with example embodiments, this device is polymer-based. For example, the device may be formed of a biodegradable polymer. The resulting biodegradable polymer may be biocompatible and bioresorbable with the ability to degrade when implanted in-vivo.

A biodegradable polymer can have crystalline and amorphous regions and are therefore, in general, semi-crystalline in nature. Degradation of a biodegradable polymer such as initiates in the amorphous regions, with the crystalline regions also degrading but at a slower rate relative to the amorphous regions. Without wishing to be tied to a theory, degradation of a polymer such as Polydioxanone (PDO) occurs along the polymer back bone by hydrolysis of the ester bonds. This non-specific ester bond scission occurs randomly along the polymer chain with water penetration initially cutting the chemical bonds and converting the long polymer chains into natural monomeric acids found in the body, such as lactic acid. Such monomeric acids are then phagocytized by the enzymatic action of special types of mononuclear and multinuclear white blood cells. The polymer is thus degraded into non-toxic, low molecular weight residues that are capable of being eliminated from the body by normal metabolic pathways, e.g. via exhalation and/or excretion. Such a pathway thereby enables reference to the breakdown of such polymers in-vivo through terminology such as absorbable, bioabsorbable, degradation, biodegradation, resorbtion, bioresorbtion, etc.

In another aspect, the biodegradable polymer may be shelf stable even after terminal sterilization, e.g. using ethylene oxide, gamma irradiation, e-beam irradiation, nitrous oxide, etc. for in vivo use. In accordance with example embodiments, the biodegradable polymer is designed to withstand terminal sterilization, such as ethylene oxide sterilization, and still maintain long-term shelf life stability and product functionality. Terminal sterilization, such as by ethylene oxide, can have a dramatic effect on the structural stability of polymers as they are either degraded into low molecular weight species or cross linked into complex polymeric systems, which can negatively alter the post-sterilization polymer properties. Accordingly, in order to provide a post sterilization, shelf-stable, biocompatible polymeric implant; the polymer, in accordance with example embodiments of the present invention, is able to survive the terminal sterilization procedure and still maintain functionality.

It has been found that post-sterilization stability is achievable by using polymers with an inherent viscosity [IV] (which is a method of evaluating the relative molecular weight of the polymeric system) that is of a sufficient starting range to endure a drop in IV post-sterilization and still meet the required implant design requirements. Without wishing to be tied to a theory, it is believed that polymers are susceptible to degrade into lower molecular weight species during terminal sterilization, thereby affecting the inherent viscosity of the implant during storage. By starting with a polymer system with an IV value in its upper range pre-sterilization, it is possible to have a sterile system, post-sterilization with an IV lower than that of the starting system but that is designed to meet the required shelf-life stability. This IV value is typically in the range of 0.5-7.0 dl/g.

Additionally, in accordance with example embodiments, the use of a specific and defined atmosphere for storage of the implant pre- and post-sterilization further adds to increasing the post-sterilization shelf-life stability of the polymer in question. One such method is the use of a controlled atmosphere, specifically one where excessive moisture is reduced via a vacuum or low moisture containing dried gases such as nitrogen, argon, etc. Furthermore, the use of packaging materials with a low moisture vapor transmission rate, for example orientated polypropylene (OPP), Polyethylene terephthalate (PET), Linear low-density polyethylene (LLDPE), polyethylene (PE), foil-based packaging materials (e.g. aluminium), or combinations thereof, in combination with a low moisture environment can further aid in enhancing the stability of the polymeric material post-sterilization.

DETAILED DESCRIPTION

Various example embodiments are described in detail herein. These embodiments generally share certain features in common. Accordingly, the various embodiments each share common features, except to the extent indicated otherwise. As such, for the sake of conciseness, the description of the common features is not repeated in connection with the description of each described embodiment. Further, features that are the same or analogous among the various embodiments are, in connection with some embodiments, given like reference numbers, but followed by a letter associated with the particular embodiment. For example, if an embodiment has an element7, the corresponding or analogous element in further embodiments would be designated7a,7b,7c, and so on. For convenience, the description of these features is not repeated in connection with each embodiment; rather, it should be understood that the description of these features in connection with other embodiment(s) applies unless indicated otherwise.

As described herein, example embodiments of the present invention provide surgical closure systems, devices, and methods. As such, provided systems, devices, and methods are useful for closing a perforation (i.e., a hole, puncture, tear, rip, or cut, etc.) in any hollow vessel associated with a mammalian surgical procedure. One of ordinary skill in the art will appreciate that the systems, devices, and methods are useful for closing a perforation in any lumen of a mammal, including, for example, the gastrointestinal tract (e.g. the stomach, intestines, colon, etc.), heart, peritoneal cavity, esophagus, vagina, rectum, trachea, bronchi, or a blood vessel.

Although certain figures and embodiments relate to use of systems and devices for closure of a perforation associated with vascular surgery, one of ordinary skill in the art will appreciate that components of a provided device are not size dependent (i.e., are scalable) and are therefore useful for closure of any perforation in a lumen of a mammal.

Some embodiments of the present invention are directed to a closure system, device, and method of percutaneous closure of an arteriotomy following an endovascular/intra-arterial procedures.

One of ordinary skill in the art will recognize that many mammalian lumina are comprised of one or more friable tissues. Thus, a common difficulty associated with surgical closure of a perforation in such lumina is that suture material, used in typical closure systems, tends to cause tears in the friable tissue. Such tearing of the luminal tissue impedes healing and causes scarring. Indeed, such tearing of the friable tissues of the internal lumina of blood vessels can lead to scarring, dislodgment of tissue particles, blockage, or even eventual death of the patient. In view of the fragile nature of luminal tissues, an aspect of example embodiments of the present invention is to provide systems, devices, and methods that allow cseal to be formed closure of a tissue perforation in a reliable manner with minimal trauma to the luminal tissue, for example, by providing a sutureless seal.

With regards to the arterial wall morphology, in the context of example embodiments directed to closing arterial perforations, the fibrous adventitial layer of an artery (i.e., the outer layer) is relatively tough, whilst the intimal and endothelial layers are friable. Because of the morphology of the arterial wall, an arteriotomy may be circumferential in nature and perpendicular to the longitudinal axis of the artery.

Closure Device

Referring toFIG. 1A, a percutaneous Vascular Closure Device (VCD)5is configured to provide relatively large vascular closures. An example of an intended application of this device5is the percutaneous closure of 12-30 F arteriotomies following endovascular/intraarterial procedures. In clinical practice, commonly targeted arteries may include, for example, the common femoral artery, the subclavian artery, axillary artery, ascending aorta, brachial artery, and other vessels used for endovascular access. At the conclusion of the interventional procedure, the implant or device5is percutaneously delivered into the artery2via a procedural sheath100(illustrated, e.g. inFIG. 30) over a guidewire150.

The device5′ shown inFIG. 1B, differs from the device5only in that the device5′ employs an extra-luminal pin80athat differs from an extra-luminal pin80of the device5. In particular, referring toFIGS. 7C and 7D, the extra-luminal pin80ahas a slot85ato facilitate the pin80abeing moved into its distal or deployed position, as described in further detail herein, while the guidewire150remains in situ, whereas the extra-luminal pin80is configured to prevent full distal extension of the extra-luminal pin80when the guidewire150remains in situ. Aside from this difference, as well as the presence of the guidewire in certain views, the devices5and5′ should be considered identical. Moreover, for the sake of conciseness, the description of the device5is considered interchangeable with the device5′, except to the extent indicated otherwise.

FIGS. 1A to 1Cillustrate final closure dynamics of the device5,5′ in situ in a sectioned artery2, withFIG. 1Ashowing the device5after removal of the guidewire150. The implant device5,5′ includes a body or foot core20, a flexible wing60, and the extra-luminal pin80,80a.

All implant device components (e.g., the foot core20, the flexible wing60, and the extra-luminal pin80,80ain the illustrated examples ofFIGS. 1A to 1C) are manufactured from synthetic absorbable materials, although other suitable non-synthetic and/or non-absorbable materials may be used instead of, or in addition to, these synthetic absorbable materials. The flexible wing60, the foot core20, and the extra-luminal pin80,80amay each be manufactured from any suitable material, e.g. Polydioxanone (PDO), Poly-L-lactide (PLLA), Poly-D-lactide (PDLA), blend of D-lactide and L-lactide, i.e. poly-DL-lactide (PDLLA), Polyglycolide (PGA), blend of Poly-L-lactide and Polyglycolide (PLGA), ε-Caprolactone, Poly (ethylene glycol) (PEG), magnesium alloy, 3-hydroxypropionic acid, Polyanhydrides, poly(saccharide) materials or combinations of these. It should be appreciated, however, that any one or more of the components of the implant device5,5′ may be formed of any suitable material. Moreover, some or all of the components of the device5may be made of the same or different materials relative to each other. The flexible wing may be manufactured as a thin sheet, it may also be made of a woven material, e.g. using electrospinning, weaving and knitting processes.

FIGS. 1A to 1Crepresent each of these components in situ. The arteriotomy seal is achieved in large part by the hydraulic haemodynamic pressure, which acts on the flexible wing60to force the flexible wing60against the luminal surface and conform to the luminal topography to seal around the arteriotomy.

FIGS. 2A to 2Dshow the assembled implant5showing three components-foot core20, flexible wing60, and extra-luminal pin80. Although the example illustrated inFIGS. 2A to 2Dconsists of three pieces, it should be appreciated that more or few pieces may be provided. For example, the flexible wing60may be integrally formed with the foot20as a single, monolithic piece.

As illustrated inFIGS. 2A and 2C, a guidewire150extends through the implant5.FIGS. 2B and 2Dshow the implant5after proximal retraction of the guidewire150and subsequent extension, or deployment, of the extra-arterial pin80to its distal, or deployed, position relative to the foot core20.

The implant5is inserted into the artery2through a procedural sheath100illustrated inFIG. 30and over the guidewire150, which extends through the sheath100and into the intra-arterial space.

Referring, for example, toFIGS. 3A to 3D, the foot core20includes both an intra-luminal section25which is configured to be maintained in the interior of the artery2, or other tissue structure, when the implant5is in situ, and an extra-luminal section40which passes through the arteriotomy across the arterial wall when the implant5is in situ. The intra-luminal section25and the extra-luminal section40are separated at a recess22, which is configured to receive the wing60such that a cylindrical recessed surface23is maintained inside a circular central cut-out or aperture65in the wing60. The aperture65is illustrated, for example, inFIGS. 6A and 6B.

It is noted that since some illustrated examples are provided in the context of an arteriotomy, the terms “intra-luminal” and “extra-luminal” may be referred to as “intra-arterial” and “extra-arterial” in the context of the illustrated embodiments, it being understood that the arteriotomy-closure application is non-limiting and the closure of any suitable tissue aperture may be performed by example embodiments of the present invention.

The extra-luminal section40of the foot core20is provided in the form of a neck42which extends from the intra-luminal section25at an angle, e.g. selected from a range from 10° to 70°, and has five primary functions:

1. Secure the flexible wing60within the recessed section22. This recessed section22also provides an effective seal between the flexible wing60and foot core20. In the example illustrated, e.g. inFIGS. 1A to 1C, the flexible wing60is free to rotate within this recess22. It should be understood, however, that the engagement of the wing60in the recess22may be provided such that the wing60is not rotatable within the recess22.

2. Secures and allows release of the entire implant to a delivery system via interlock recesses45in the neck42. This functionality is described in further detail elsewhere herein.

3. Houses the extra-luminal pin80and secures it when deployed to its final position.

5. The 10°-70° incline on the neck in combination with the extra-luminal pin80, or80a, also provides, e.g. for safety purposes, protection against the implant being pushed off the luminal surface by application of extracorporeal pressure above the implantation site or due to patient movements.

The intra-luminal section25of the foot core20has a primary function to provide a rigid scaffold to support the flexible wing60. The underside of the intra-luminal section25may be concave in cross-section to reduce its profile within the artery2and has a hollow entry portion or port52of the guidewire channel50adjacent the neck42, shown in the sectioned foot core20ofFIG. 3D.

FIGS. 4A to 4Fshow another foot core20a. This configuration has a circular intra-luminal portion25ain plan view and a concave surface30awhich is concave in cross-sectional profile within the artery2.

It should be appreciated that many variations of the intra-luminal portion may be provided, only a limited number of which are shown herein. For example,FIGS. 5A to 5Bshow another foot core20bhaving an intra-luminal portion25bthat is generally rectangular in plan view and includes a concave bottom surface.

The flexible wing60,FIGS. 6A and 6B, is a thin disc sized to be larger than the arteriotomy diameter (arteriotomy diameter is equivalent to the outer diameter of the delivery/procedural sheath100). The central hole65and disc portion are circular in shape, in plan view. It should be understood, however, that other geometries may be provided for the hole and/or the disk portion of the wing60. The central hole65is sized to accept recessed cylindrical surface23within the foot core20's flexible-wing retention recess22shown, e.g. inFIGS. 3A and 3B, and is free to rotate relative to the foot core20about the concentric axis of the recessed cylindrical surface23.

FIG. 6Ashows the flexible wing60in its flat and relaxed state, andFIG. 6Bshows the flexible wing60in its curved state, which corresponds to the final configuration within the artery2. The curvature of the wing60shown inFIG. 6Bcorresponds to the curvature of the interior of the artery to which the wing60conforms in its final implanted state. When implanted, the wing60is pressed against the artery interior wall by hemodynamic hydraulic pressure exerted by the blood in the artery2. Although the wing60is flat, or planar, in its relaxed state, it should be appreciated that the wing60may be curved or have any other suitable geometry in its relaxed state.

Referring, e.g. toFIGS. 1A to 1C, the flexible wing60is positioned within the artery2against the luminal surface3adjacent the arteriotomy and held in this position with the aid of the hemodynamic hydraulic pressure it acts as the primary seal around the arteriotomy to control bleeding. Referring toFIG. 1C, the wing60is illustrated slightly pulled away from the luminal surface3only to facilitate illustration.

In addition to elastically deforming to conform to the luminal surface3of the artery2, the flexible wing60also elastically deforms to fit within the procedural sheath100for delivery into the artery2. This is achieved by rolling the wing60into a cylinder-like configuration. Once within the artery2, and beyond the procedural sheath100, the flexible wing60intrinsically recovers towards its flat state to allow the hemodynamic hydraulic pressure in the artery2to conform the wing60to the shape of the arterial luminal and surface topography3. In this regard, the elasticity of the wing60allows the wing60deform locally at differing areas of the luminal surface3of the artery2. This allows the wing60to conform to local irregularities along the surface3to ensure that the arteriotomy is adequately sealed despite such irregularities.

The flexibility of the wing60is not just important in a lateral configuration to facilitate collapse during delivery, but it is also important to flex in a longitudinal plane. Flexibility in both lateral and longitudinal planes is important to ensure an effective seal around the arteriotomy of arteries in differing disease states with different surface topographies and varying anatomical configurations. Longitudinal flex is facilitated by the configurations shown, e.g. inFIGS. 2A-5D, by the flexible wing60and the foot core20being separate and distinct parts that are non-fixedly mated together. For example, since the wing60is not fixed to the foot20, it is able to separate from the upper surface of the relatively rigid intra-luminal portion25of the foot core20at regions where the topography of the arterial surface3deviates or is disposed at a greater distance from the upper surface of the intra-luminal portion25than at adjacent regions of the surface3.

Although the wing60has a circular outer periphery, it should be understood that the wing60may be provided with any suitable geometry. Further, although the wing60has a uniform thickness, it should be understood that the wing60may be provided with a thickness that varies at different regions of the wing60. For example, the wing60could have a thickness in its central region that is greater than a thickness toward the circumferential periphery of the wing60.

FIGS. 7A and 7Bshows an assembled implant5in cross section.FIG. 7Ashows the implant5in a state where the guidewire150would be in situ, as illustrated, e.g. inFIG. 32, or subsequent to removal of the guidewire150.FIG. 7Bshows the deployed implant5.

The extra-luminal pin80is a safety feature of the closure system to prevent the implant being pushed off the luminal surface by application of extracorporeal pressure above the implantation site or due to patient movements. The extra-luminal pin80in the illustrated example does not generally contribute to or form part of the sealing function of the implant5. The implant5will seal the arteriotomy in the absence of the extra-luminal pin80in accordance with some example embodiments. The extra-luminal pin80is deflected parallel to the artery2wall as it is advanced, as illustrated, e.g. inFIG. 7B. This deformation of the extra-luminal pin80helps secure it in its post deployment position. The pin80is also maintained in this position via a press fit between the proximal portion82of the pin and the proximal recess47of the foot core20into which the proximal portion82is pressed.

Depending on implant design and requirements, the extra-luminal pin80may also be used to occlude the guidewire hole within the foot core20when deployed, e.g. in a configuration such as illustrated inFIGS. 7A and 7B, the pin80being illustrated in isolation inFIG. 7C. When deployed, as illustrated, e.g. inFIG. 7B, an enlarged proximal portion82of the extra-luminal pin80blocks the guidewire channel50. In its proximal or retracted position, the pin80allows the guidewire150to pass through channel83in the enlarged proximal portion82. When the pin80is moved into its distal or deployed position, the channel83does not align with the channel50in the foot core20, thereby blocking the channel50. In the proximal or retracted position, the guidewire is able to pass through both channels50and83since the channels50and83are sufficiently axially spaced apart.

It should be understood, however, that any other suitable mechanism may be provided for closing the guidewire channel50. For example, again referring toFIGS. 7A and 7B, the formation of coagulated blood in the conically shaped entry portion52of the guidewire channel50. The coagulated blood would then be pressed and locked into the narrowing conical geometry of the entry portion52by the hydraulic pressure exerted by the blood in the artery2. To facilitate coagulation of the blood in the entry portion52, the guidewire150may be left in place for, e.g. several minutes (e.g. 4 to 5 minutes). The presence of the guidewire may, during this period, induce sufficient clotting of the blood to form the closure in the entry portion52. Then, upon retraction of the guidewire150, the coagulated blood would compress and collapse to fill the void left by the removal of the guidewire150.

Although the illustrated entry portion52of the guidewire channel50is conical, it should be appreciated that any suitable geometry may be provided. Referring toFIG. 7D, an alternative extra-luminal pin80ais shown with an additional slot85ato facilitate the pin80abeing moved into its distal or extended position whilst the guidewire150remains in place.

Some alternative embodiments to the extra-luminal pin80shown, e.g. inFIG. 7C, are shown inFIGS. 8A to 12B.

Referring toFIGS. 8A and 8B, provided are a series of protrusions80cthat, in the radially extended position ofFIG. 8B, engage the extra-arterial subcuticular tissue to prevent the implant from being pushed forward. The protrusions80care exposed and allowed to spring into their radially extended position by proximal retraction of an outer shaft sleeve84cconfigured to radially constrain and cover the protrusions80cwhen the outer shaft sleeve84cis in the distal position illustrated inFIG. 8A.

FIGS. 9A and 9Bshow an extra-luminal pin80dattached to a suture86d, which when pulled proximally, flips the pin forward to engage the extra-arterial subcuticular tissue to prevent the implant being inadvertently pushed forward. The suture86dmay include a series of knots87dto lock and hold the pin80din any desired angle between the position shown inFIG. 9Aand the position shown inFIG. 9B, depending on, e.g. tissue thickness and/or resistance. The suture86d, or any other suture described herein, may be formed of any suitable material. For example, any of the sutures described herein may be formed, in whole or in part, of a bio-absorbable material.

FIGS. 10A and 10Bshow an arrangement similar to that shown inFIGS. 9A and 9B. In this arrangement, the extra-luminal pin80eis attached to a suture86e; however the pin80ehas a pivot attachment or joint81eto connect to the foot core20e. By pulling the suture86e, the pin flips forward, via rotation about the pivot attachment81e, to engage the extra-arterial subcuticular tissue of the artery2to prevent the implant from being pushed forward. The suture86emay include a series of knots87eto lock and hold the pin80ein any desired angle between the position shown inFIG. 10Aand the position shown inFIG. 10B, depending on, e.g. tissue thickness and/or resistance.

FIGS. 11A and 11Bshow an arrangement that is similar to that ofFIGS. 10A and 10B, but without a suture. The pin80fhas a pivot joint or attachment81fto the foot core20factivated by movement of an outer shaft sleeve84fto engage the extra-arterial subcuticular tissue of the artery2to prevent the implant from being inadvertently pushed forward. The sleeve84fmay engage an angled surface of the pin80fto begin rotation of the pin80fabout the pivot attachment81f. The pin may be moved to the position shown inFIG. 11Bby any suitable mechanism. For example, the pin80fmay be spring biased toward the position shown inFIG. 11B, with the sleeve84f, disengaging a latch, detent, or other mechanism that maintains the pin80fin the position shown inFIG. 11A.

FIGS. 12A and 12Bshow an extra-luminal T-bar80gattached to the end of a suture86g, which when pulled proximally, engages the T-Bar80gwith the extra-arterial subcuticular tissue to prevent the implant from being inadvertently pushed forward. The suture86gmay include a series of knots87gto lock and hold the pin80gin any desired angle or position between the position shown inFIG. 12Aand the position shown inFIG. 12B, depending on, e.g. tissue thickness and/or resistance.

FIGS. 13A to 18show variations on the configuration of the foot core.

The foot core20hofFIG. 13Ahas the intra-luminal portion25hoff-set proximally, toward the rear of the neck section42h. The intra-luminal portion25his circular in shape but the extra-luminal portion40hmeets the intra-luminal portion25hat a location that is non-concentric to the circular cross-section of the intra-luminal portion25h. An advantage to this bias is that during delivery of the implant, specifically, as the delivery device is withdrawn from the artery to position the implant against the arteriotomy, the biased intra-luminal portion25hoffers more security or overlap between the intra-luminal portion25hof the foot core20hand the distal wound edge of the arteriotomy to prevent inadvertent pull-out from the artery.

The foot core20iofFIG. 13Bis similar to the foot core20hofFIG. 13A, but with a larger angle between the intra-luminal section25iand the neck42iof the implant. The larger angle has the advantage of further encouraging the heel of the intra-arterial implant to remain within the artery2during withdrawal of the delivery device60and positioning the implant against the lumen adjacent to the arteriotomy to prevent inadvertent pull-out from the artery2. This assumes a constant withdrawal angle of the delivery device (described in additional detail herein) of 60 degrees. However, a larger angle increases the tolerance on the withdrawal angle and still ensures the implant hooks or otherwise engages the rear wall of the arteriotomy. The increase in angle between the neck42iand intra-luminal foot section25imay be limited by what will reasonably fit through a loading funnel, which is described in further detail elsewhere herein.

To increase the flexibility of use, for example, another variation is to make the neck flexible. For example,FIG. 14shows a foot core20jwith a flexible neck42j. The neck42jof the implant transitions from a round cross-section at its distal section to an elliptical cross-section at its proximal end. This allows the neck42jto flex during its insertion through the loading-funnel.

Further variations to that shown inFIG. 14is to articulate the implant relative to a delivery device as shown inFIGS. 51A to 51C. These configurations allow articulation between the delivery device and the implant. Securement of the implant to the delivery device is achieved by securing paddles or interlock projections165k,165mof retaining tubes160k,160mof a delivery device in place in corresponding interlock recesses45k,45mand preventing them from moving in a lateral direction by providing an external sleeve, such as, e.g. a release sleeve such as release sleeve175described in further detail herein.

The configuration ofFIGS. 51A and 51Bdiffers from that ofFIG. 51Cin that the interlock recesses45kofFIGS. 51A and 51Bextend laterally entirely though the wall of the neck42k, whereas the recess45mofFIG. 51Cdoes not.

Further variations to impart flexibility to the implant neck is shown inFIGS. 15A and 15B. Here, the flexibility is imparted via a reduced cross section in at least a portion of the neck42n,42p. The configuration ofFIG. 15Adiffers from that ofFIG. 15Bin thatFIG. 15Ahas a reduced cross-sectional geometry in only a portion its extra-luminal portion, whereas the configuration ofFIG. 15Bhas a constant narrow cross sectional geometry along its extra-luminal portion.

FIG. 51Dshows a variation on the attachment of the implant to the delivery device. In particular, the interlock projections165rof the retaining sleeve160rhave hooked portions that extend laterally inwardly to engage recesses45r.

FIG. 16shows a further embodiment of the foot core. This configuration differs in that the foot core20thas no retaining feature to secure the flexible-wing to the foot core20t. That is, the foot core20tdoes not have a recess or any other particular mechanism configured to retain the wing60on the foot core20t. In this example, the flexible wing60may be secured by an interference fit between the foot core's neck42tand the central opening65within the flexible wing60. This may facilitate the assembly of the flexible wing60onto the foot core20t.

Referring toFIGS. 17A to 17C, a further variation of this concept is to assemble the flexible wing60onto the neck42uof the foot-core20uand then secure the wing60in place by the addition of a through pin or the further assembly of a collar195uwith an interference fit between the collar195uand foot core's neck42u. The collar195umay further be secured by one or more projections configured to engage with corresponding one or more recesses in neck section42u.

FIG. 18provides another extra-luminal pin80w. In this example, an additional feature to secure the extra-luminal pin80wwithin the foot core20wis to incorporate a taper lock when the enlarged proximal or rear portion82wof the extra-luminal pin80wengages with the foot core20w.

The conical taper lock between the extra-luminal pin80wand the foot core20wrelies, in this example, on the foot core taper being at a lesser angle than the taper on the mating surfaces of the extra-luminal pin80w. This taper-lock not only enhances the lock between the two components80w,20wonce positioned relative to each other, but also improves the potential fluid seal between the two components with respect to sealing the guidewire channel50w.

Referring toFIGS. 19 to 27, a further closure device or implant5yincludes all of the features of the other closure devices, e.g. closure device5, except to the extent indicated otherwise.

The closure device5yincludes a foot core20yhaving a profile that is “hybrid” in that it shares geometric features with both a round foot core, such as, e.g. the foot core20ashown inFIG. 4A, and an elongated foot core, such as, e.g. the elongated foot core20shown inFIG. 3C. Referring for example, toFIG. 27, the hybrid foot core20yhas rounded portions56yand projecting portions57y.

The rounded portions56yextend around the portion of the foot core20ythat extends through the flexible wing60to provide increased lateral surface area of the foot core20y, adjacent the opening in the wing60and the arteriotomy to be sealed. This region of increased lateral surface area provides for a greater sealing between, e.g. the foot core20yand the wing60.

The projecting portions57ygive the intra-luminal portion of the hybrid foot core20yan elongated shape. This elongated shape further limits the ability of the foot core from being inadvertently pulled back through the arteriotomy when the operator is setting the closure device5yin into its implanted position.

Thus, the hybrid foot core20ymay provide the sealing advantages of a wide or rounded foot core as well as the setting benefits of an elongated foot core.

The geometry of the hybrid foot core20yprovides support to the artery in both a longitudinal direction and transverse direction. Although the foot core20khas a circular central region, it should be understood that any suitable widened geometry, e.g. oval, square, rectangular and/or polygonal, with rounded and/or sharp corners. This central region provides a flaring out of the profile of the intra-luminal portion of the foot core20kin the region where the neck of the foot core20kpasses through the flexible wing60.

In a manner analogous to that of the device5illustrated, e.g. inFIGS. 7A and 7B, the pin80ymay be used to occlude the guidewire hole within the foot core20ywhen deployed, e.g. in a configuration such as illustrated inFIG. 21. When deployed, as illustrated, e.g. inFIG. 21, an enlarged proximal portion82yof the extra-luminal pin80yblocks the guidewire port or channel50y. In its proximal or retracted position, the pin80yallows the guidewire to pass through channel83yin the enlarged proximal portion82y. When the pin80yis moved into its distal or extended position, the channel83ydoes not align with the channel50yin the foot core20y, thereby blocking the channel50y. In the proximal or retracted position, the guidewire is able to pass through both channels50yand83ysince the channels50yand83yare sufficiently axially spaced apart.

Referring, for example, toFIG. 25, the channel83yin the pin80yis elongated to allow for increased freedom of movement of the guidewire within the channel83y.

FIGS. 28A to 28Bshow a front perspective view of a foot core20zthat differs from the foot core20yin that the lateral portions56zare partially flattened to provide a reduced width. This flattening or facing results in two flat surfaces58z. By reducing the width of the foot core20zrelative to the foot core20y, greater clearance is provided between the foot core20zand the loading funnel396or loading cannula335described in further detail herein. This allows a larger diameter or thicker flexible wing60to be loaded by facilitating more clearance and hence, a larger amount of the flexible wing60to overlap within the loading funnel and loading cannula thereby reducing the potential for premature and unfavorable interaction between the footcore and overlapping flexible wing.

Nevertheless, the foot core20zmay provide similar benefits to the rounded portions56ydue to the lateral projection of the portions56zrelative to the width of the lateral portions56zrelative to the width of the projecting portions57z. As with the foot core20y, this increased width is provided at a location adjacent the location where the extra-luminal portion40zextends through the aperture in the flexible wing60.

Thus, the foot core20zreduces the width of the lateral projections, but only to an extent that does not substantially affect the sealing between, e.g. the foot core20zand the wing60.

As with the foot core20y, the foot core20zmay provide the sealing advantages of a widened or rounded foot core as well as the setting benefits of an elongated foot core.

Referring toFIG. 29, which is not drawn to scale, the wing60includes an anterior surface61, which contacts the luminal surface of the artery when implanted, and a posterior surface64, which faces the lumen of the artery and the blood flow when implanted.

The anterior surface61and/or the posterior surface64is provided with an altered wettability, i.e., a change in surface energy from the native, e.g. smooth, surface finish. This change in wettability may be provided in the form of electrical charge, surface texture, protein attachment, mechanical scraping, chemical etching, laser etching and/or other etching, shot blasting (using various shot media), plasma discharge, manufacturing process that encourage functional end groups at the surface, and/or any other suitable form. This change in surface energy encourages cell (or thrombocyte) attachment or adhesion directly or via protein attachment, extracellular matrix and/or adhesion molecule to the luminal surface of the flexible-wing or, conversely, discourage cell or protein attachment. In the illustrated example, the wettability of the anterior surface61is increased in order to encourage attachment or adhesion. Cellular attachment or platelet aggregation on the luminal surface61of the flexible wing60aids and expedites sealing as well as anchoring the intra-arterial implant. This change in surface energy also encourages the adhesion, via a change to the surface tension of the modified material, to the surrounding soft tissue.

Referring to example embodiment ofFIG. 29, the anterior surface61of the wing60is roughened, e.g. abraded, to created grooves or channels62having a depth63on the order of, for example, 1-100 μm. In some examples, the depth may be on the order of 7-10 μm. It should be understood, however, that the depth63may fall within a substantially larger, smaller, and/or different range. The area of abrasion may be continuous or provided in a patterned arrangement. These channels or grooves62facilitate cell attachment (e.g. leukocytes, erythrocytes and particularly thrombocytes) and aggregation. As indicated above, this aggregation of cell promotes thrombogenesis which also forms an attachment to the luminal wall of the artery above the wing60. This cellular attachment to both the artery wall and anterior surface of the wing60may act as a secondary seal. The cellular attachment to the surface61of the wing60may occur, for example within seconds of the wing60being implanted.

The posterior surface64is relatively flat in the illustrated example. It should be understood, however, that the posterior surface64may be provided with a texture in some example embodiments. Further the posterior surface64may be provided with any other mechanism of altered wettability, either increased or decreased, as may be suitable.

Delivery System for Delivering the Closure Device

The closure device5is designed to be delivered into the artery2, or other suitable location, via the procedural sheath100used in the interventional procedure over a guidewire150in the illustrated examples. Hence, the delivery sequence may start with the sheath100and guidewire150in situ within the vessel2. The procedural sheath100of the illustrated example includes a hub110containing a valve and typically a side arm120, as illustrated, e.g. inFIG. 30. In particular,FIG. 30, shows an 18 F introducer sheath100having hub110with valves and side-arm120.

The side arm120may be used, for example, to inject contrast to confirm the position of the sheath100relative to the arteriotomy or pressured saline to prevent the sheath100from back filling with blood. The valve assembly within the hub110is provided to allow the introduction of devices of varying diameters into the sheath100and prevents blood loss through the rear of the sheath100. The guidewire150, which extends through the longitudinal lumen of the sheath100, is provided as a safety feature which allows percutaneous re-access to the arterial lumen as a contingency if needed.

Referring toFIGS. 31A and 31B, a delivery system1includes a delivery device90. The delivery device90has a handle93at its proximal end and a flexible shaft92, which attaches to the implant5at the distal end.FIGS. 31A and 31Bshow the implant attached at distal end of the delivery device and within artery2.

The shaft92includes three flexible concentric slidable tubes155,160,175. The inner tube (pusher-tube155, illustrated inFIG. 7A) is configured to push the extra-luminal pin80from its proximal delivery position, as shown, e.g. inFIG. 2A, to its distal post deployment position, as shown, e.g. inFIG. 2B. The pusher-tube155has an internal diameter sized to accept the guidewire150. The middle tube (retaining-sleeve160) and outer tube (release-sleeve175) in combination retain and release the implant which is attached to the distal end of the delivery system as shown inFIGS. 33A to 33C.

Referring toFIG. 35, the handle93is attached to the proximal end of the shaft93and is used to control the relative position of the implant5, push the extra-luminal pin80and release the implant5. As shown inFIG. 35, the handle93has its right-hand-side external cover removed from the mated left-hand-side cover94to expose the internal components of the handle93.

Handle components: With reference toFIG. 35, the thumb button180activates the push-tube155to push forward the extra-luminal pin80. The retaining-sleeve anchor169anchors the retaining-sleeve160to the handle93in a fixed position. The release-sleeve hub177connects the release sleeve175to a slide switch185, which when slid proximally or backwards pulls the release sleeve177backwards or proximally relative to the retaining sleeve160to release the implant5.

FIG. 52shows another handle200configured to be mated to the shaft92in manner analogous to the handle93. The handle200includes: a first housing portion205, a second housing portion210, a guidewire extension tube215, a pusher tube hub220, a retaining sleeve hub225, a release sleeve hub230, a lock member240, and a thumb slider250.

The thumb slider250is configured to move along a linear guideway formed by housing203, which includes the first and second housing portions205and210. In particular, the thumb slider250is configured to move, due to, e.g. manual actuation by the thumb of a human operator, between a first position and a second position. The first position is shown, for example, inFIGS. 54A to 54F, and the second position is shown, for example, inFIGS. 55A to 55C.

The guidewire150runs through the pusher tube155and through the handle, including through the guidewire extension tube215and out the proximal or rear end of the handle200. The guidewire extension tube215is supported by support ribs216of the housing203.

The handle200is configured such that movement of the thumb slider250from the first position to the second position causes the extra-luminal pin80of the implant5to move from its proximal delivery position as shown, e.g. inFIG. 2Ato its distal post deployment position as shown, e.g. inFIG. 2B.

The lock member240is configured to prevent the deployment of the extra-luminal pin80prior to removal of the guidewire150from the delivery device. The lock member240is configured to be pressed transversely into the housing203from a first position illustrated, for example, inFIG. 54B, to a depressed second position illustrated, for example, inFIG. 54Dwhen the user wishes to unlock the thumb slider250.

Referring toFIG. 53, the lock member240includes a projection248that is received in a corresponding recess213, illustrated inFIG. 52, of the housing203. When the projection248is received in the recess213, the lock member240is prevented from being depressed. In order to depress the lock member240, the projection248must be moved out of engagement with the recess213. This mechanism prevents, or at least reduces the likelihood of, inadvertent depression of the lock member240prior to insertion of the guidewire—for example, when the device is removed from its packaging, which is described in additional detail below.

In order for the operator to move the projection248out of engagement with the recess213, the user applies a proximally directed force to the lock member240. The lock member240includes a pair of slots241and242that allow a portion247between the slots241to be bend or flex with respect to the remainder of the lock member240when the operator applies the proximally directed force. Since the projection248is disposed on the portion247, this bending of the portion247causes the projection248to move out of engagement with the recess213, thereby allowing the lock member240to be depressed.

When the lock member240is in the non-depressed first position, a locking tab244extends into a space in the thumb slider250adjacent a locking surface252, such that the interface between the locking tab244of the lock member240and the locking surface of the thumb slider250forms a positive stop to prevent the thumb slider250from moving axially away from the lock member240. Since the lock member250is constrained to the housing203in a fixed axial position, the positive stop between the lock member240and the thumb slider250prevents the thumb slider250from being slid forward to its distal position, thus preventing the corresponding actuation of the extra-luminal pin80into its deployed position.

In order to unlock the thumb slider250to allow deployment of the extra-luminal pin80, the user depresses the lock member240to move the lock member from its first position to its depressed second position, illustrated, for example, inFIG. 54E. In the depressed position, the locking tab244moves out of engagement with the thumb slider250, such that the locking surface252of the thumb slider250does not contact the locking tab244of the lock member240as the thumb slider250is pressed and moved forward or distally to thereby deploy the extra-luminal pin80.

To prevent the lock member240from being depressed prior to removal of the guidewire150, the lock member240is provided with a through hole243through which the guidewire150passes during positioning of the implant5. When the guidewire150extends through the through hole243, as illustrated inFIGS. 54A and 54B, the lock member240is prevented from being depressed, since the guidewire150engages the through hole243to block the lock member240from moving laterally with respect to the guidewire and into the depressed position.

Although the lock member240is provided with a through hole in the illustrated example, it should be understood that any suitable geometry, e.g. a slot, notch, and/or flat surface, may be provided to engage the guidewire150and thereby block movement of the lock member240.

FIG. 54Bshows the guidewire150being removed from the device in the direction of the arrow superimposed on the housing203, until the guidewire150is fully withdrawn as illustrated inFIG. 54C. After the guidewire150is withdrawn, the guidewire150no longer extends through the through hole243, as illustrated, e.g. inFIG. 54C. Thus, the lock member240is no longer prevented from being depressed.

Referring toFIG. 54E, the lock member240includes a projection246that engages a first recess201when the lock member240is in the first position and that engages a second recess202when the lock member240is in the depressed second position. This engagement allows the lock member240to be retained in the respective first and second positions, but allows movement upon application of a force sufficient to overcome the engagement. Thus, the projection246and the recesses201and202function as detent mechanisms.

After the lock member240is depressed to disengage the lock member244from the thumb slider250, as illustrated, e.g. inFIG. 54D, the user may slide the thumb slider250distally, in the direction illustrated by the arrow inFIG. 54F, until the slider reaches its distal second position, as illustrated, for example, inFIG. 55A.

This distal movement of the thumb slider250results in deployment of the extra-luminal pin80. As with the handle93, the handle200achieves the actuation of the extra-luminal pin80from its delivery position to its deployed position by distally pushing the pusher tube155. In particular, the proximal end of the pusher tube155is attached to the pusher tube hub220, which is in turn coupled to the thumb slider250. Thus, as the thumb slider250moves distally or forward, the pusher tube hub220is also moved distally or forward, thereby also moving the pusher tube155forward to push the extra-luminal pin80from its proximal position to its extended deployed position.

Referring toFIGS. 52 and 53, the pusher tube hub220includes grooves221that receive respective corresponding linear guide ribs or projections206in the housing203to function as a linear slide. One of the guide ribs206is illustrated as part of the first housing portion205, the second housing portion210being essentially identical, but mirrored, with respect to the first housing portion205. The pusher tube hub220also includes a projection222that is received in a corresponding recess or groove251of the thumb slider250to constrain the projection222and thereby transfer proximal and distal motion of the thumb slider250to the pusher tube hub220.

As the thumb slider250and the pusher tube are pushed distally relative to the housing203, the retaining sleeve160and the release sleeve175remain stationary with relative to the housing. Thus, the pusher tube155is pushed relative to the retaining sleeve160and the release sleeve175, and therefore also relative to the implant5supported by the retaining sleeve160and the release sleeve175.

The retaining sleeve160is maintained in its stationary position relative to the housing203by being mounted in a retainer hub compartment207of the housing203, as illustrated, for example, inFIGS. 52 and 54A. In the illustrated example, the retaining sleeve is maintained in a stationary position relative to the housing203during all stages of operation of the surgical system. It should be understood however, that the retaining sleeve may be configured to move relative to the housing during one or more stages of operation of the system.

The release sleeve175is maintained in its stationary position relative to the housing203during the forward movement of the thumb slider250by distal and proximal stops of the housing203that engage the release sleeve hub230to constrain distal and proximal movement, respectively. The distal stop is formed by a projection or wall209of the housing203, as illustrated, e.g. inFIG. 55B, while the proximal stop is formed by a hub lock208of the housing203, as illustrated, e.g. inFIGS. 56A and 56B.

Referring toFIG. 53, a front face231of the release sleeve hub230contacts the distal stop and projections232contact the proximal stop. In the illustrated example, two projections232engage a pair of respective hub locks208; however, it should be understood than any number of projections232, including a single projection232may be provided to engage any number of hub locks208, including a single hub lock208.

After deployment of the intra-luminal pin80, the next procedural step is to release the implant5from the delivery device. In order to do so in the illustrated example, the user needs to move the release sleeve175proximally relative to the retaining sleeve160. The mechanism for releasing the implant5upon the relative motion between the release sleeve175and the retaining sleeve160is described in further detail elsewhere in the present description.

In order to move the release sleeve175proximally relative to the retaining sleeve160, which remains stationary relative to the housing203, (a) the proximal lock, which is the hub lock208in the illustrated example, must be disengaged from the release sleeve hub and (b) the thumb slider250engages the release sleeve hub230such that proximal movement of thumb slider250relative to the housing203causes corresponding movement of the release sleeve hub230, and therefore also the release sleeve175, relative to the housing203and the retaining sleeve160.

Referring toFIGS. 53, 56A, and 56B, the thumb slider250includes a pair of cam sliders253that engage the respective hub locks208as the thumb slider250approaches its distal second position. In particular, the distal advancement of the ramped or sloped surfaces254aof the cam sliders253causes the hub locks208to move laterally and clear of the projections232of the release sleeve hub230. Continued distal advancement of the thumb slider250causes the hub locks208to slide along flat surfaces254bof the respective cam sliders253to maintain the hub locks208in their disengaged positions.

The hub locks208may be configured as cantilevered projections from the housing203that flex in the lateral direction in the manner of a leaf spring, while maintaining sufficient rigidity in the axial direction to resist proximal movement of the release sleeve hub230when engaged therewith. Moreover, any other suitable proximal locking mechanism may be provided.

After the hub locks208are moved out of alignment with the projections232of the release sleeve hub230, a clip member255, which slides over a ramped or sloped surface233of the release sleeve hub230, latches with the release sleeve hub230by engaging with distally facing latch surface234of the release sleeve hub230.

After latching of the thumb slider250to the release sleeve hub230, the operator moves the thumb slider250proximally to a proximal third position in the direction of the arrow shown inFIG. 57A, to retract the release sleeve hub230and the release sleeve175to the position shown inFIG. 57B. Although in the illustrated example, the proximal third position of the thumb slider corresponds to the proximal first position of the thumb slider, it should be understood that the first and third positions may be different.

The cam surfaces254aand254bare of sufficient length in the illustrated example to maintain the disengaged position of the hub locks208until the proximally directed faces of the projections232of the release sleeve hub230have proximally cleared the distally facing stop surfaces of the hub locks208.

When the device is in the state illustrated inFIG. 57B, the implant5is released from the end of the delivery device via the proximal movement of the release sleeve175relative to the retaining sleeve60.

The thumb slider250further includes a projection256that engages a corresponding recess212in the housing203when the thumb slider250is in the proximal position. This engagement allows the lock member240to be retained in the respective first and second positions, but allows movement upon application of a force sufficient to overcome the engagement. Thus, the projection256and the recess212function as a detent mechanism.

Prior to withdrawal of the distal end of the delivery device, the thumb slider250may be again moved distally, to a fourth position, as illustrated inFIG. 57C. Moving the thumb slider250to the distal fourth position causes the release sleeve175to move distally with respect to the retaining sleeve160, which causes the distal end of the release sleeve175to at least partially cover the interlocking projections165of the retaining sleeve160, which are illustrated, for example, inFIG. 33A. Re-covering or re-sheating these projections165may be advantageous to reduce the risk of trauma to the surrounding tissue as the delivery device is withdrawn from the percutaneous tissue tract.

Although in the illustrated example, the distal fourth position of the thumb slider corresponds to the distal second position of the thumb slider, it should be understood that the first and third positions may be different.

To facilitate passage of the release sleeve hub230distally past the hub locks208, the release sleeve hub230may be provided with ramped or sloped chamfer surfaces236, which are illustrated inFIG. 53. These surfaces236, which slope downwardly as they extend distally along the release sleeve hub230, engage the hub locks208as the release sleeve hub230is moved distally in order to move raise the hub locks208to prevent the hub locks208from axially blocking the projections232of the release sleeve hub230.

The shaft92is designed to push the implant5down the procedural sheath100into the artery2and allow control of the implant's relative position by the user from the handle93.

Implant retention and release: Referring, e.g. toFIGS. 33A to 33C, to secure the implant5on the distal tip of the delivery device90, two profiled interlock projections165which extend from the retaining sleeve160engage into the implant's matching interlock recesses45in the neck42of the foot core20. To ensure the profiled projections165remain engaged with the foot core20, a release-sleeve175is positioned in a distal or forward location, as illustrated inFIG. 33C, to prevent the projections165from moving laterally outwardly.

To release the implant5from the distal tip of the delivery device90, the release-sleeve175is slid back to expose the interlock projections165on the retaining-sleeve160. The tip of the retaining-sleeve160is split longitudinally, via longitudinal splits or notches167, to allow lateral movement of the interlocking projections165, and the rear shoulders of interlocking recesses45on the foot core20may be ramped, as illustrated, e.g. inFIGS. 34A to 34B, to facilitate release of the implant5by pulling the delivery device90away from the implant5. It should be understood, however, that any suitable geometry may be provided, e.g. a perpendicular edge, under-cut, etc, to mate with appropriate geometries of the interlocking projections165.

Further, mating surfaces of the interlock projections165and the interlocking recesses45may be provided with one or more radial protrusions that engage with one or more corresponding radial recesses. For example, an interlocking projection165may include a plurality of radial protrusions that engage a corresponding plurality of radial recesses of a mated interlocking recess45, or the interlocking recess45could be provided with the radial protrusions that mate with corresponding radial recesses of the interlocking projection165. Further, the interlocking recess45could have at least one recess and at least one protrusion, the at least one recess and the at least one protrusion respectively mating with corresponding at least one protrusion and at least one recess of the interlocking recess45. These various surface recess/protrusion configurations may provide a high level of securement (e.g. in the axial direction) between the interlocking projections165and the interlocking recesses45. Moreover, these various surface recess/protrusion configurations may be provided alone or in combination with other interlocking mechanisms between the interlocking projections165and the interlocking recesses45.

Although the interlocking projections165extend straight along the length of the retaining sleeve160, it should be appreciated that the projections165may be flared outwardly, such that retraction of the release sleeve175allows the interlock projections165to spring outwardly away from their interlocking engagement with the interlock recesses45.

Referring toFIG. 36, the loading funnel95is used to compress the flexible wing60of the implant into a cylindrical shape to allow it to fit within the procedural sheath100for delivery. The loading funnel95is also used to insert the compressed implant and delivery system into the procedural sheath100through the sheath's valve, as shown inFIG. 30. The loading funnel95, in accordance with some exemplary embodiments, is used immediately prior to delivery to avoid storage of the flexible wing60in the compressed state and potentially taking a memory set shape in the compressed form.

The loading funnel in the illustrated example includes four components namely, the funnel or funnel body96, cap97, seal98, and seal-retainer99shown inFIG. 36. It should be understood however that the loading funnel may have more or fewer components.

The cap97and seal98are pre-loaded on the shaft92of the delivery device90proximal to the implant5. The funnel96is advanced over the implant5, large opening end first, to compress the wing60into a cylindrical shape as the tapered section of the funnel96is advanced over the implant5. The funnel96is advanced until the implant5is resident in the cylindrical section130of the funnel96.FIG. 37shows the relative positions of the funnel body96, cap97, and seal98to the implant5and shaft92of the delivery device90during advancement of the funnel96relative to the implant5.

Once the implant5is disposed in the cylindrical section130of the funnel96, the cap97is now attached to the funnel96, which forms a seal with the delivery device's shaft92.

FIG. 38shows the relative position of the implant5within the funnel96after being loaded therein.

Loading funnel configurations: The loading funnel95in a very simple form may be a tapered funnel. However, to encourage the flexible wing60to fold when loaded into the funnel body96, an alternative option is to provide a funnel body96athat includes a protrusion132aalong the tapered section131awhich extends into the cylindrical section130a, as shown inFIGS. 39A to 39C. With this option, the loading funnel95ais positioned relative to the flexible wing60to encourage one side of the wing60to be lifted above the opposite leaflet of the wing60during insertion.

Referring toFIGS. 40A and 40B, a third option is to have a splitable funnel96bfor removal from the shaft92of the delivery device90once the implant5is delivered through the procedural sheath hub110and valve. Once the implant5is within the procedural sheath100, the funnel95bmay be withdrawn from the sheath valve, its cap97bthen removed, and the funnel body or section96bmay then be opened, via separation of two subparts connected at split line134to remove the funnel body96bfrom the shaft92of the delivery device90.

The above-described loading funnel concepts require the cap97,97a,97bto be pre-loaded onto the shaft92of the device1proximal to the implant5and the funnel96,96a,96bto be advance over the implant5and shaft92. Referring toFIGS. 41A and 41B, a fourth concept is to have the funnel95cpre-loaded onto the shaft92, proximal to the implant5, and advance the funnel95cdistally over the implant5to compress the flexible wing60into the cylindrical section130cand into the cannula section135cof the loading funnel95c. The tapered section131cand cylindrical section130cof the funnel body96cis completely removable from the cannula135c, as illustrated inFIG. 42A. The loading cannula130ais cylindrical in shape and is used to insert the implant5and device90through the procedural sheath valve and into the procedural sheath100for delivery into the artery2. The delivery cannula130,130aand135cmay be chamfered at it distal end to assist in penetrating the valve at the rear of the procedural sheath100. As illustrated inFIG. 42Athe funnel body96chas been removed after loading the implant5into loading cannula135c.

FIG. 42Bshows the components of the loading funnel95c, including loading cannula135c, detachable funnel96c, end cap97c, seal98c, and seal retainer99c. The loading cannula135cand detachable funnel96cform the funnel body95cin this example. The proximal end of the delivery cannula135cis adapted to form a seal around the shaft92of the device90but allow the shaft92to axially slide relative to the cannula135c. This configuration of loading funnel95calso has the advantage of protecting the implant5during storage and handling of the device90.

FIGS. 43A to 43Mshow alternative funnel bodies96d,96e,96f,96g, and96h. These funnel bodies96d,96e,96f,96g, and96hmay be used in connection with, for example, the preloaded loading funnel95cshown inFIG. 41A, in place of funnel body96c, or in place of any of the other funnel bodies recited herein.

Referring toFIG. 43A, the detachable funnel section or body96dincludes a longitudinal split140dto facilitate removal of the funnel section from the guidewire150. This split140dmay be a discontinuation of the component to provide a gap, or allow a gap to be formed (e.g. via flexing of the funnel body96d) for the guidewire150to pass there through during removal. This split may also be formed by physical removal of a strip of material from the funnel wall, for example as a peelable strip.

Referring toFIGS. 43B to 43D, the funnel body96eincludes a weakened or notched section145ethat allows the funnel wall, in this example, to have a continuous integral internal surface which can easily be split along the weakened or notched section145e. In the illustrated example, the weakened section is provided as a longitudinally extending groove or channel that weakens the structure of the funnel wall. The weakened or notched section145emay be split, for example, by manual exertion of force by an operator.

The open split arrangement ofFIG. 43Aand the weakened wall arrangement ofFIGS. 43B to 43Dmay, in some examples, be notched at the beginning of the splits or pre-split weakened portions to allow ease of locating the guidewire into the split, e.g. to facilitate relative movement of the guidewire from the inner lumen of the funnel body to the exterior of the funnel body via the split.

For example, referring toFIGS. 43E TO 43G, a split funnel body96f, which includes features analogous to the split funnel body140dofFIG. 43A, further includes a notch142f, which is continuous with the split140f.

It should be appreciated that a split or splittable funnel body concept is applicable to any funnel arrangement in the context of the present invention. Further, although the splits or split lines of the illustrated examples are coplanar with the longitudinal axes of the respective funnel bodies, it should be appreciated that the split or split line may be non-coplanar and/or have an irregular path.

Moreover, although the illustrated examples include a single split or split line, it should be appreciated that multiple splits or split lines or any combination of splits and split lines may be provided. Further, a respective split line may be split at one or more locations along the length of the split line and weakened so as to be splittable at one or more other locations along the split.

Other mechanisms for removing the funnel body may include, for example, cutting or tearing the funnel body, e.g. with a cutting tool, in the presence or absence of predetermined split lines such as the split lines described above.

FIG. 43Hshows a perspective view of a staged funnel body96hthat may be used in connection with, e.g. any of the funnel arrangements described herein. As shown, the staged funnel body96hincludes two distinct tapered or funnel-shaped portions162gand164gseparated axially by a constant-diameter (in this example, cylindrical) portion163g. Sections161gand130gare at opposed axial ends of the funnel body96hand are, in this example, cylindrical. The staged funnel body96provides a progressive folding of the implant in two distinct sections.

FIGS. 43J to 43Mshow an offset funnel body96h, which may be used in connection with, e.g. any of the loading funnel arrangements described herein. In this arrangement, the overall central axis A of the funnel body96his nonlinear, such that the central axis along the enlarged introduction portion171his offset with regard to central axis along the narrowed cylindrical portion172h, with a transition provided along tapered or funnel-shaped portion173h. In this embodiment, the off-set funnel body96hbiases the shaft of the delivery device and hence the flexible-wing to the side of the funnel as illustrated. It may be advantageous for the funnel body96hto be at a particular orientation relative to the implant5during loading.

Although the tapered geometry of the various funnel bodies described herein may in some examples be illustrated as being conical or of a constant taper angle, it should be understood that curved and/or irregular tapers may be provided in addition, or as an alternative, to the illustrated funnel bodies.

FIGS. 44 to 50show a delivery sequence in accordance with exemplary embodiments of the present invention.

The delivery of the implant5starts with the procedural sheath100and guidewire150percutaneously positioned in situ.

The delivery sequence depends on which variant of loading funnel is used. For example, if any of the loading funnel shown inFIGS. 36 to 40Bare used, then the first step may be to load the loading funnel onto the guidewire150. If, for example, the loading funnel shown inFIGS. 41A to 42Bis used then this step may be omitted. For simplicity the following sequence describes an exemplary delivery method using the loading funnel95shown inFIGS. 36 to 38.

Step 1: Back load the guidewire150into the foot core20and the shaft92and handle93of the device90. This step is generally illustrated inFIG. 44.

Step 2: Insert the implant5into the funnel96to compress the flexible wing60, and place the cap97and seal98(as well as retainer99) onto the rear of loading funnel96. This step is generally illustrated inFIGS. 45A and 45B.

Step 3: Insert the loading funnel95(and the other components of the device90), which houses the implant5, into the hub110and valve115at the rear of the procedural sheath100. This step is generally illustrated inFIGS. 46A and 46B.

Step 4: As illustrated inFIGS. 47A and 47B, the delivery device90and implant5are advanced down the procedural sheath100into the artery2to deliver the implant5into the arterial lumen (just distal to the procedural sheath tip) of the artery2. Alternatively, the implant may be delivered into the arterial lumen by being advanced down the procedural sheath100into the artery2to deliver the implant5just proximal to the procedural sheath tip, then holding the delivery device90stationary (once the implant is positioned at the sheath tip) and withdrawing the sheath100over the delivery device90the required amount to expose the implant5. This avoids pushing the exposed implant5upstream within the artery2.

Step 5: Withdraw the procedural sheath100from the artery2and position the implant5in juxtaposition to the arteriotomy. The implant5is now controlling the bleeding from the arteriotomy. This step is generally illustrated inFIG. 48.

Step 6: Once confirmed that the implant5is correctly positioned and effecting a seal, the guidewire150is withdrawn, the extra-luminal pin80is deployed, and the implant is released. This step is generally illustrated inFIGS. 49A and 49B.

Step 7: Withdraw the procedural sheath100and delivery device90from the tissue tract to leave the implant (foot core20, flexible wing60, and extra-luminal pin80) implanted to complete the delivery of the implant5and sealing of the arteriotomy. This step is generally illustrated inFIG. 50.

The above delivery sequence steps outline a method of implant deployment, there are many possible variants on this sequence to suit clinical requirements or preferences. For example, it may be advantageous to leave the guidewire150in situ through the implant after implant release, to maintain arterial percutaneous access, and remove the guidewire150when judged clinically appropriate. In this regard, it is noted that, as indicated above, in some embodiments, e.g. the version having extra-luminal pin80a, the guide wire may remain in place even after deployment of the pin.

Referring toFIGS. 59 and 60, the loading funnel/cannula assembly395includes a loading cannula335and an offset loading funnel396analogous to the loading funnel96hshown, for example, inFIG. 43J. Referring to the exploded view ofFIG. 60, the cannula335includes a cannula tube336, a cannula cap397, a cannula seal398, and a cannula seal retainer399that function in a manner analogous to other like components described herein, e.g. the components of the assembly illustrated, e.g. inFIG. 42B.

Closure Product and Packing

FIG. 58shows a packaged product300, that includes a surgical device301packaged in a protective tray400. The surgical device301includes the same features of the other analogous example devices described herein, except to the extent indicated otherwise.

The surgical device301includes, inter alia, the handle200as described in additional detail herein, and a loading funnel/cannula assembly395, which is analogous to other loading funnel/cannula arrangements described herein.

As illustrated inFIG. 58, the surgical device301is held in a recess405shaped to closely match the geometry of the surgical device301by tabs or projections410.

The product300is configured such that the device301is removable from the tray400by proximally pulling the device301from the tray400. In this example, the offset loading funnel396is retained in the tray as the remainder of the device301is withdrawn proximally from the tray.

To remove the device from the tray, the operator grips handle200protruding from the proximal end of the tray400, e.g. between the thumb and fingers. While holding the tray400in the opposite hand or supporting the tray on a suitable surface for stability, the user may withdraw the device301proximally in a straight smooth continuous motion until the device301is completely free of the tray. Since the funnel396is retained in the tray400as the remainder of the device301is withdrawn, the implant2held by the device301moves proximally along the loading funnel/cannula assembly395such that the flexible wing of the implant5is folded by the funnel as the implant progresses toward the loading cannula335. Upon further pulling the device301, the implant5moves into the tube336of cannula335, which maintains the folded configuration of the implant5until the implant5is deployed along the guidewire as described in further detail herein with regard to other examples.

Upon further retraction of the device301, a positive stop engages between the loading cannula335and the shaft of the device301, such that the cannula335is pulled away from and breaks free of the loading funnel396. Upon further retraction of the device301, the device301is freed from the tray, with the loading funnel396retained in the tray.

Referring toFIG. 61, the positive stop that engages between the cannula335and the shaft of the device300is formed between a loading cannula retaining ring360and the cap397of the cannula335.

The device300includes an alignment mark175that extends longitudinally along the device300to provide a visual indication that the device301is properly rotated with respect to the tray400and the offset loading funnel396to ensure that the wing of the implant5is properly folded by the funnel396. Geometric engagement of the device301with the tray400also facilitates this alignment. The alignment of the offset funnel396is facilitated by the geometry of the tray400, the recess405of which is shaped to match the offset of the funnel396to thereby resist rotation of the funnel396.

The tray400also includes a cover450that prevents inadvertent actuation of the lock member240, thumb slider250or any other operable mechanism of the handle300while the device301is in the tray400.

The tray400may provide a specific and defined atmosphere for storage of the implant pre- and post-sterilization, which may further add to increasing the post-sterilization shelf-life stability of the polymer from which the exemplary implant5is formed. One such mechanism is the use of a controlled atmosphere, specifically one where excessive moisture is reduced by means of use of a vacuum or low moisture containing dried gases such as nitrogen, argon, etc. Furthermore, the use of packaging materials with a low moisture vapor transmission rate, for example orientated polypropylene (OPP), Polyethylene terephthalate (PET), Linear low-density polyethylene (LLDPE), polyethylene (PE), foil-based packaging materials (e.g. aluminium), or combinations thereof, in combination with a low moisture environment can further aid in enhancing the stability of the polymeric material post-sterilization.

FIG. 62shows the components of the device301once removed from the tray400, with the implant5being folded and loaded into the loading cannula335. The device301further includes an insertion mark380that provides the operator with a visual indication of how deep to insert the device301into the procedural sheath100.

Although some example embodiments have been described herein in the context of vascular closure applications, it should be understood that the various mechanisms and concepts described herein are not limited to vascular applications and are applicable to any suitable applications that require closure of an aperture in a tissue.

Although the present invention has been described with reference to particular examples and exemplary embodiments, it should be understood that the foregoing description is in no manner limiting. Moreover, the features described herein may be used in any combination.