Patent Description:
An occluder is a medical device used to treat (e.g., occlude) tissue at a target site within the human body, such as an abnormality, a vessel, an organ, an opening, a chamber, a channel, a hole, a cavity, a lumen, or the like. For example, an occluder may be used to occlude or close an atrial septal defect (ASD), a ventricular septal defect (VSD), or a patent foramen ovale (PFO), which are generally characterized as holes in the subject tissue. Percutaneous and surgical procedures have been developed to deploy occluders - or other implantable devices - within these defects. In other instances, other defect closure devices, such as annuloplasty rings or valves secured to the subject tissue, have also been used.

However, it is recognized that employing these devices to close tissue defects may have various disadvantages, such as introducing foreign objects into the patient's body, tissue erosion, development or exacerbation of allergies (e.g., nickel allergies), and blood flow issues around the device.

<CIT> discloses a minimally invasive fixation device for fixating a feltable textile at a target site. The feltable material is fixated at the target site in a human or in an animal and comprises an elongate tubular member, a needle and a drive assembly. The elongate tubular member has a proximal end and a distal end and an interior lumen extending between the proximal end and the distal end. <CIT> discloses an implantable closure apparatus and method for sealing or closing openings at internal body locations. The apparatus and methods involve the delivery and attachment of a patch, patch and plug, or plug only to seal or close the opening. The closure apparatus and methods may be used to close a patent foramen ovale (PFO). <CIT> discloses an electrophysiology mapping and visualization system to visualize tissue regions as well as map the electrophysiological activity of the tissue. Such a system may include a deployment catheter and an attached hood deployable into an expanded configuration.

The present disclosure is directed to a patch delivery assembly for treating a target site. The patch delivery assembly includes a patch installation frame including a self-expanding body extending between a proximal end and an open distal end and defining a lumen therethrough. The patch delivery assembly also includes a delivery cable having a distal end coupled to the proximal end of the patch installation frame and further defining the lumen, and a securement device extending through the lumen defined through the delivery cable and the patch installation frame. The securement device terminates in a distal working end including a securement mechanism. In a deployment configuration of the patch delivery assembly, the patch delivery assembly further comprises a patch releasably coupled to the distal end of the patch installation frame, for securement to tissue of the target site using the securement mechanism.

Corresponding reference characters indicate corresponding parts throughout the several views of the drawings. It is understood that that figures are not necessarily to scale.

The present disclosure relates generally to medical devices that are used in the human body. Specifically, the present disclosure provides a delivery assembly for delivering, deploying, and installing an occlusive patch at a target site (e.g., a tissue defect, such as a hole through tissue at the target site).

The disclosed embodiments may lead to more consistent and improved patient outcomes. It is contemplated, however, that the described features and methods of the present disclosure as described herein may be incorporated into any number of systems as would be appreciated by one of ordinary skill in the art based on the disclosure herein.

Although the exemplary embodiment of the medical device is described as treating a target site including a hole through the subject tissue, such as an atrial septal defect (ASD), a ventricular septal defect (VSD), a patent foramen ovale (PFO), or a left atrial appendage (LAA), as the medical device may be configured to treat any target site that could benefit from occlusion, such as an abnormality, a vessel, an organ, an opening, a chamber, a channel, a hole, a cavity, or the like, located anywhere in the body. Other physiological conditions in the body occur where it is also desirous to occlude a vessel or other passageway to prevent blood flow into or therethrough. These device embodiments may be used anywhere in the vasculature where the anatomical conditions are appropriate for the design.

As used herein, the term "proximal" refers to a part of the medical device or the delivery device that is closest to the operator, and the term "distal" refers to a part of the medical device or the delivery device that is farther from the operator at any given time as the medical device is being delivered through the delivery device. In addition, the terms "deployed," "installed," "secured," and "implanted" may be used interchangeably herein.

The medical device may include one or more layers of occlusive material, wherein each layer may be comprised of any material that is configured to substantially preclude or occlude the flow of blood so as to facilitate thrombosis. As used herein, "substantially preclude or occlude flow" shall mean, functionally, that blood flow may occur for a short time, but that the body's clotting mechanism or protein or other body deposits on the occlusive material results in occlusion or flow stoppage after this initial period.

The present disclosure now will be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the disclosure are shown. Indeed, this disclosure may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements.

Turning now to <FIG> and <FIG>, an example embodiment of a patch delivery assembly <NUM> is shown. Patch delivery assembly <NUM> includes a patch installation frame <NUM> and a securement device <NUM>. In a delivery or deployment configuration, as shown in <FIG> and <FIG>, patch delivery assembly <NUM> also includes a patch <NUM>, which is secured or coupled to a distal end <NUM> of patch installation frame <NUM>, as described further herein.

A proximal end <NUM> of patch installation frame <NUM> is coupled to a distal end <NUM> of a delivery cable <NUM>. Patch installation frame <NUM> and delivery cable <NUM> share a common lumen (not specifically shown) through which securement device <NUM> extends. Specifically, securement device <NUM> extends distally from a proximal end (not shown) of the lumen (not shown) through delivery cable <NUM> and patch installation frame <NUM> and terminates at a distal working end <NUM>. Distal working end <NUM> includes a securement mechanism (not specifically shown) that facilitates securing patch <NUM> to tissue at a target site (e.g., to occlude a hole in the tissue at the target site using patch <NUM>). For instance, distal working end <NUM> may include a suture mechanism, a staple mechanism, an adhesive mechanism, a thermal bonding mechanism, or any other mechanism (or combination thereof) suitable to secure patch <NUM> to the tissue at the target site.

In one example embodiment, patch delivery assembly <NUM> is navigated to a patch installation site (e.g., a tissue defect <NUM>, as shown in <FIG>, also referred to herein as a target site) using a delivery catheter <NUM> (see <FIG>). For instance, delivery catheter <NUM> may be introduced to the patient's body via transfemoral insertion or any other suitable method. Patch installation frame <NUM> is constricted within delivery catheter <NUM> in a collapsed or contracted delivery configuration, shown partially in <FIG>. Once at the patch installation site (e.g., tissue defect <NUM>), patch installation frame <NUM> is advanced from a distal end <NUM> of delivery catheter <NUM>, as shown in <FIG>. For example, delivery cable <NUM> may be advanced distally through delivery catheter <NUM> and/or delivery catheter <NUM> may be withdrawn proximally while maintaining a position of patch installation frame <NUM>.

Once deployed from delivery catheter <NUM>, patch installation frame <NUM> expands to an expanded, installation configuration, as shown in <FIG> and <FIG>. As patch installation frame <NUM> expands, so too does patch <NUM>. Specifically, because patch <NUM> is coupled to distal end <NUM> of patch installation frame <NUM>, patch <NUM> is expanded to an installation configuration upon deployment and expansion of patch installation frame <NUM>. In the installation configuration, patch <NUM> is maintained under tension and in a desired installation position by patch installation frame <NUM>.

Patch installation frame <NUM> defines a confined securement path or area about which distal working end <NUM> of securement device <NUM> is maneuverable relative to distal end <NUM> of patch installation frame <NUM> and, thereby, relative to patch <NUM>. Distal working end <NUM> of securement device <NUM> is maneuverable relative to patch installation frame <NUM>, as described in greater detail herein, to secure (e.g., suture, staple, adhere, etc.) patch <NUM> to the tissue at the target site, using the associated securement mechanism.

Once patch <NUM> is secured to the tissue, patch <NUM> provides an occlusive effect; that is, patch <NUM> blocks or substantially blocks blood flow therethrough. Patch <NUM> is then decoupled from patch installation frame <NUM>, as described further herein, and patch delivery assembly <NUM> (now including no patch) is retracted into delivery catheter <NUM> and withdrawn from the target site. Patch <NUM> remains secured to tissue at the target site, providing an occlusive or substantially occlusive effect while minimizing an amount of material introduced into the patient's body (e.g., limited to patch <NUM> and any material(s) securing patch <NUM> to the tissue). Moreover, patch <NUM> has a significantly reduced profile compared to other known occlusive devices, and therefore limits bulging around the tissue defect and any associated blood flow effects thereof.

In the illustrated embodiment of patch delivery assembly <NUM>, patch installation frame <NUM> has a tapered shape in its deployed or expanded configuration. Specifically, patch installation frame <NUM> includes a body <NUM> that tapers outwardly from proximal end <NUM> to distal end <NUM> thereof. Thereby, body <NUM> of patch installation frame <NUM> has a "cone" shape, which can have convex (see <FIG> and <FIG>) or concave (see <FIG>) walls <NUM>, or, in still other embodiments, generally straight tapered walls <NUM>. The walls <NUM> of body <NUM> define a cavity <NUM> therewithin. In the illustrated embodiment of patch installation frame <NUM>, distal end <NUM> is "open," when patch <NUM> is not coupled thereto. That is, patch installation frame <NUM> is formed with an open, unobstructed distal end <NUM> free of the material forming patch installation frame <NUM>, to enable securement device <NUM> to readily access patch <NUM> without interfering material. In some embodiments, cavity <NUM> may contain a nesting structure (not shown) to help support and guide securement device <NUM>, such as, but not limited to, a nesting nitinol braided structure.

Body <NUM> of patch installation frame <NUM>, in its expanded configuration, has a distal diameter <NUM> and a corresponding distal circumference <NUM>. Distal diameter <NUM> may vary, depending on the application thereof (e.g., depending on a size, a shape, or a configuration of tissue defect <NUM>). Distal diameter <NUM> is sized such that patch <NUM> will cover tissue defect <NUM>. For example, distal diameter <NUM> may be about <NUM> up to about <NUM>, and may accommodate patch <NUM> having a patch diameter <NUM> of, for example, <NUM> to <NUM>, or up to <NUM> in some embodiments. Patch <NUM> may be sized such that patch <NUM> is larger, smaller, or substantially similar in size as patch installation frame <NUM> (e.g., patch diameter <NUM> may be larger, smaller, or substantially similar in size to distal diameter <NUM>). Body <NUM> of patch installation frame <NUM> also has a length <NUM> (see <FIG>), defined along a longitudinal axis thereof. The length <NUM> is sized such that distal end <NUM> may expand and reach its full diameter (e.g., distal diameter <NUM>). Therefore, depending upon the appropriate distal diameter for the application, length <NUM> may vary.

In some embodiments, length <NUM> is related to distal diameter <NUM> in accordance with a predefined ratio. For example, the predefined ratio of length <NUM> to distal diameter <NUM> may range from about <NUM>:<NUM> to <NUM>:<NUM>. In some embodiments, the predefined ratio of length <NUM> to distal diameter <NUM> may be <NUM>:<NUM>. The predefined ratio of length <NUM> to distal diameter <NUM> may depend on the size of patch <NUM>, with patch <NUM> having a diameter in a range of about <NUM> to about <NUM>. For example, the predefined ratio of length <NUM> to distal diameter <NUM> of <NUM>:<NUM> may be available for patch <NUM> having the <NUM> diameter.

In one example embodiment, patch installation frame <NUM> is formed from a shape-memory material, such that patch installation frame <NUM> expands to its expanded configuration upon deployment thereof. In one particular embodiment, patch installation frame <NUM> is formed from a braided metallic shape-memory material, such as nitinol. For example, patch installation frame <NUM> may be formed from an insulated nitinol material, such as, but not limited to, a <NUM> strand nitinol material with <NUM> strands being conductive to facilitate patch suture release. It is also understood that patch installation frame <NUM> may be formed from various materials other than nitinol that have elastic properties, such as stainless steel, trade named alloys such as Elgiloy®, or Hastalloy, Phynox®, MP35N, CoCrMo alloys, metal, polymers, or a mixture of metal(s) and polymer(s). Suitable polymers may include PET (Dacron™), polyester, polypropylene, polyethylene, HDPE, Pebax™, nylon, polyurethane, silicone, PTFE, polyolefins and ePTFE. Additionally, it is contemplated that patch installation frame <NUM> may comprise any material that has the desired elastic properties to ensure that the frame may be deployed to its expanded configuration and recaptured in a manner disclosed within this application.

In one particular embodiment, patch installation frame <NUM> is formed by folding the shape memory material upon itself, such that the fold defines distal end <NUM> of patch installation frame <NUM> (also referred to as distal end <NUM> of body <NUM>). In some such instances, the shape memory material is initially formed as a braided tubular structure, which is cut to a desired length, folded upon itself, and heat-set over a mandrel to define the expanded configuration thereof. The free ends of the braided, folded shape-memory material, at proximal end <NUM> of patch installation frame <NUM> (also referred to as proximal end <NUM> of body <NUM>), may be welded, crimped, adhered, or otherwise stabilized to prevent unraveling of the braided shape-memory material. In some embodiments, proximal end <NUM> of patch installation frame <NUM> is coupled to distal end <NUM> of delivery cable <NUM> after the free ends of the braided material have already been fixed. In other embodiments, the free ends of the braided material at proximal end <NUM> of patch installation frame <NUM> are simultaneously fixed and secured to distal end <NUM> of the delivery cable <NUM>. Proximal end <NUM> of patch installation frame <NUM> (e.g., including the free ends of the folded, braided shape-memory material) is coupled to distal end <NUM> of delivery cable <NUM> by adhesive, welding, melting, over-molding, internal molding, or any other suitable attachment method. In at least some embodiments, the free ends of the braided, folded shape-memory material are coupled to an exterior surface of delivery cable <NUM>, such that the free ends do not interfere with any components positioned within delivery cable <NUM> (e.g., securement device <NUM>).

Additionally, proximal end <NUM> of patch installation frame <NUM> defines a lumen or channel therethrough (not specifically shown). In the example embodiment, this lumen is shared with (e.g., is continuous with) a lumen defined through delivery cable <NUM> (not specifically shown). Accordingly, various components, such as securement device <NUM>, can be advanced through the lumen and into cavity <NUM> of patch installation frame <NUM>.

Patch <NUM> is coupled to distal end <NUM> of patch installation frame <NUM>. In some embodiments, patch <NUM> is coupled to patch installation frame <NUM> along the fold that forms distal end <NUM> of patch installation frame <NUM>. In other embodiments, patch <NUM> is coupled interior to or exterior to the fold. Patch <NUM> may be comprised of any suitable flexible and occlusive material that allows for patch <NUM> to provide a sealing, occlusive effect. Examples of suitable material may include, but are not limited to, polyester, polyethylene, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePFTE), decellularized extracellular matrix (ECM), Dacron™, and xenograft pericardium, such as bovine pericardium.

In one or more embodiments, patch <NUM> also includes a radiopaque material coupled thereto. The radiopaque material is visible under fluoroscopy and enables (<NUM>) verifying the position of patch <NUM> during deployment and securement thereof, and (<NUM>) identification or confirmation of the position of patch <NUM> at some later date, such as during check-ups or before some other kind of medical intervention. In some such embodiments, a marker of radiopaque material (e.g., a radiopaque marker) is positioned at or along the circumference of patch <NUM>. For example, a plurality of discrete radiopaque markers may be attached to (e.g., sutured or sewn to) an outer edge <NUM> of patch <NUM> at regular intervals, to identify the perimeter of patch <NUM> under fluoroscopy. Alternatively, a wire or thread formed from radiopaque material may be attached to (e.g., sutured or sewn to, woven into, etc.) the entire outer edge of patch <NUM>. In still other embodiments, patch <NUM> may be impregnated with the radiopaque material.

Patch <NUM> has a shape and size that generally corresponds to a shape and size of distal end <NUM> of patch installation frame <NUM>, because patch installation frame <NUM> is configured to maintain patch <NUM> in a taut, tensioned configuration upon deployment and during securement of patch <NUM> to the tissue. That is, where patch installation frame <NUM> has a circular distal end <NUM>, patch <NUM> may be circular as well. The patch diameter <NUM> of patch <NUM>, and the corresponding circumference, is such that the patch <NUM> covers tissue defect <NUM>. For example, diameter <NUM> may be about <NUM> to about <NUM>, in different embodiments, and a corresponding circumference. In some embodiments, patch diameter <NUM> of patch <NUM> is substantially the same as distal diameter <NUM> of distal end <NUM> of patch installation frame <NUM> in its expanded configuration. In some other embodiments, patch diameter <NUM> of patch <NUM> is slightly smaller than distal diameter <NUM>, to ensure patch <NUM> is fully stretched when patch installation frame <NUM> expands. In still other embodiments, patch diameter <NUM> of patch <NUM> is larger than distal diameter <NUM>, but patch <NUM> is coupled to patch installation frame <NUM> along a path radially interior of the circumference of patch <NUM> (e.g., the radial distance around the outer edge <NUM> of patch <NUM>), such that patch installation frame <NUM> still maintains patch <NUM> in a taut configuration upon deployment.

It should be readily understood that although the shape of patch <NUM>, and distal end <NUM> of patch installation frame <NUM>, are depicted and generally described as round or circular, other shapes or configurations are contemplated within the scope of the present disclosure. For example, patch <NUM> and/or distal end <NUM> of patch installation frame <NUM> may have an oval shape, a square/rectangular shape, a crescent shape, or any other regular or irregular shape. The selected shape may depend, in some instances, on the shape or size of the defect to be occluded. In some embodiments, a circular or round patch <NUM> may be selected, with overall dimensions to fully cover the defect, regardless of its shape. In other cases, a patch <NUM> may be selected that has a shape more closely corresponding to a shape of the defect to be covered. References to "diameter," circumference," and the like may therefore be broadly interpreted to cover other similar dimensions, for shapes other than round/circular.

The patch <NUM> is coupled to patch installation frame <NUM> by a single continuous thread of suture material <NUM>. Suture material <NUM> couples patch <NUM> to patch installation frame <NUM> along the circumference of patch installation frame <NUM>. In some embodiments, one or both free ends (not shown) of suture material <NUM> extends proximally through the lumen (not shown) of patch installation frame <NUM> and delivery cable <NUM> (e.g., to a handle of patch delivery assembly <NUM>, not shown). In such cases, once patch <NUM> is secured to the tissue, as described herein, suture material <NUM> is trimmed by an operator and is thereby de-threadable from patch <NUM> and patch installation frame <NUM> for withdrawal, in a single piece, from the target site. In other instances, securement device <NUM> may be withdrawn from the target site, and a detachment device may be advanced to the target site (e.g., through the lumen). The detachment device may cut suture material <NUM> or otherwise decouple the patch from the patch installation frame <NUM>. In still other instances, suture material <NUM> holding patch <NUM> may be ablated to remove the suture. For example, electrical energy may be applied to patch installation frame <NUM> to burn off suture material <NUM> and release patch <NUM>. It is contemplated that patch <NUM> may be otherwise coupled to patch installation frame <NUM> in a detachable manner, via adhesive(s), staple(s), etc..

As described herein, securement device <NUM> extends through the lumen defined through the delivery cable <NUM> and the patch installation frame <NUM>. In the example embodiment, distal working end <NUM> of securement device <NUM> not only includes the corresponding securement mechanism, but also is deflectable, rotatable, and/or otherwise steerable. For instance, a proximal end of securement device <NUM> (not shown) is coupled to a handle or other operator interface of patch delivery assembly <NUM>. In response to operation of one or more controls, distal working end <NUM> of securement device <NUM> may deflect and/or rotate.

As shown in <FIG>, in the example embodiment, distal working end <NUM> is deflectable and rotatable (e.g., "steerable") with a <NUM>° range of motion. In particular, distal working end <NUM> is steerable throughout cavity <NUM> of patch installation frame <NUM> and, more specifically, along the circumference thereof. That is, distal end <NUM> of patch installation frame <NUM> confines distal working end <NUM> of securement device <NUM> within cavity <NUM> thereof, and defines a securement path for distal working end <NUM> (e.g., along an interior surface of the circumference of distal end <NUM>). Securement device <NUM> may also be activated in response to operation of one or more controls, such that the corresponding securement mechanism on distal working end <NUM> is activated to secure patch <NUM> to adjacent tissue as distal working end <NUM> is steered along the securement path. Thereby, patch <NUM> is secured to the tissue at the target site.

Thereafter, as described above, patch <NUM> is decoupled from patch installation frame <NUM>, and patch delivery assembly <NUM> (sans patch <NUM>) is retracted and withdrawn from the target site. Patch <NUM> remains coupled to the tissue, providing an immediate occlusive or substantially occlusive effect.

In some embodiments, patch delivery assembly <NUM> is deliverable through a <NUM> Fr delivery catheter (e.g., delivery catheter <NUM>, shown in <FIG>). In particular, patch delivery assembly <NUM> may be configured such that the profile of patch installation frame <NUM> and/or patch <NUM> is deliverable through a <NUM> Fr delivery catheter. Moreover, in the example embodiment, patch delivery assembly <NUM> is sized such that securement device <NUM> is extendable through the lumen of patch installation frame <NUM> and delivery cable <NUM>. In some embodiments, patch installation frame <NUM> and/or patch <NUM> may have a reduced profile. For example, patch delivery assembly <NUM> may be deliverable through a delivery catheter of less than <NUM> Fr, such as from about <NUM> Fr to about <NUM> Fr. In other embodiments, patch installation frame <NUM> and/or patch <NUM> may have an expanded profile. For example, patch delivery assembly <NUM> may be deliverable through a delivery catheter of more than <NUM> Fr, such as from about <NUM> Fr to about <NUM> Fr.

<FIG> depict side views of deployment of an alternative embodiment of patch delivery assembly <NUM> using the delivery catheter <NUM>. In the illustrated alternative embodiment of patch delivery assembly <NUM>, patch installation frame <NUM> has a wheel shape in its deployed or expanded configuration. Specifically, body <NUM> of patch installation frame <NUM> has a circular shape with one or more inner spokes <NUM>. The one or more inner spokes <NUM> may facilitate increased radial strength of patch installation frame <NUM>. Distal working end <NUM> of securement device <NUM> is maneuverable relative to patch installation frame <NUM>, for insertion between the one or more inner spokes <NUM> of the wheel shape of patch installation frame <NUM>.

<FIG> depict views of the distal end of the patch delivery assembly to illustrate a range of motion of the securement device of the embodiment of the patch delivery assembly shown in <FIG>. In the illustrated alternative embodiment of patch delivery assembly <NUM>, patch installation frame <NUM> is formed having higher edges to facilitate improved maneuverability of securement device <NUM> due to an increase in space to engage the tissue.

Turning now to <FIG>, a flow diagram of an exemplary method <NUM> for deploying a patch (e.g., patch <NUM>) at a target site is illustrated. In the exemplary embodiment, method <NUM> includes positioning <NUM> a patch delivery assembly (e.g., patch delivery assembly <NUM>) at the target site. The patch delivery assembly may include (i) a patch installation frame (e.g., patch installation frame <NUM>) including a self-expanding body extending between a proximal end and an open distal end and defining a lumen therethrough, (ii) a delivery cable (e.g., delivery cable <NUM>) having a distal end coupled to the proximal end of the patch installation frame and further defining the lumen, and (iii) a securement device (e.g., securement device <NUM>) extending through the lumen defined through the delivery cable and the patch installation frame. The securement device terminates in a distal working end including a securement mechanism. In a deployment configuration of the patch delivery assembly, the patch delivery assembly may further include a patch releasably coupled to the distal end of the patch installation frame.

Method <NUM> also includes deploying <NUM> the patch installation frame from a delivery catheter. Deploying <NUM> the patch installation frame includes (a) expanding the patch installation frame from a constricted delivery configuration to an expanded deployment configuration and (b) simultaneously expanding the patch coupled to the patch installation frame.

Method <NUM> further includes abutting <NUM> the distal end of the patch installation frame and the patch against tissue at the target site, securing <NUM> the patch to the tissue using the securement mechanism, and de-coupling <NUM> the patch from the patch installation frame.

Method <NUM> may include additional, alternative, and/or fewer steps, including those described herein. In some embodiments, securing <NUM> includes rotating the securement mechanism through a <NUM>° securement path defined by the distal end of the patch installation frame. Securing <NUM> may include suturing, adhering, or stapling the patch to the tissue using the securement mechanism. In other embodiments, de-coupling <NUM> may include trimming a one or more threads of suture material coupling the patch to the distal end of the patch installation frame.

In some embodiments, method <NUM> may include coupling the patch to the patch installation frame prior to positioning <NUM>, which may include threading one or more threads of suture material about a circumference of the distal end of the patch installation frame and through the patch. In some instances, deploying <NUM> includes proximally retracting the delivery catheter, and/or distally advancing the delivery cable through the delivery catheter.

Moreover, in some embodiments, method <NUM> may include verifying a position of the patch delivery assembly prior to securing <NUM> the patch. This verifying may include, for example, performing contrast injection(s) under fluoroscopy, to verify the device is in the proper location and the defect is covered prior to securing the patch. Additionally or alternatively, verifying may include detecting any radiopaque material coupled to and/or integrated into the patch. In some embodiments, method <NUM> may further include withdrawing the patch delivery assembly from the target site while leaving the patch secured to the tissue at the target site.

While embodiments of the present disclosure have been described, it should be understood that various changes, adaptations and modifications may be made. Further, all directional references (e.g., upper, lower, upward, downward, left, right, leftward, rightward, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise) are only used for identification purposes to aid the reader's understanding of the present disclosure, and do not create limitations, particularly as to the position, orientation, or use of the disclosure. It is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative only and not limiting. Changes in detail or structure may be made without departing from the scope spirit of the disclosure as defined in the appended claims.

Claim 1:
A patch delivery assembly (<NUM>) for treating a target site, the patch delivery assembly comprising:
a patch installation frame (<NUM>) comprising a self-expanding body (<NUM>) extending between a proximal end (<NUM>) and an open distal end (<NUM>) and defining a lumen therethrough;
a delivery cable (<NUM>) having a distal end (<NUM>) coupled to the proximal end (<NUM>) of the patch installation frame (<NUM>) and further defining the lumen; and
a securement device (<NUM>) extending through the lumen defined through the delivery cable (<NUM>) and the patch installation frame (<NUM>), the securement device (<NUM>) terminating in a distal working end (<NUM>) including a securement mechanism,
wherein, in a deployment configuration of the patch delivery assembly (<NUM>), the patch delivery assembly further comprises a patch (<NUM>), the patch (<NUM>) configured for securement to tissue of the target site using the securement mechanism; and
characterised in that the patch (<NUM>) is releasably coupled to the distal end (<NUM>) of the patch installation frame (<NUM>) by a single continuous thread of material (<NUM>).