Patent Description:
Open resection of ascending aneurysms and in particular aortic dissections, carries a high mortality. In type A dissections, the mortality with open repair may reach up to <NUM>%, many patients dying from bleeding complications or cerebral complications associated with using deep hypothermic circulatory arrest (DHCA). The friability of the tissues in these patients is a significant challenge when reconstructing and sewing a graft to the distal ascending aorta and the proximal arch, which in turn increases the duration of DHCA and therefor the complication and mortality rates. Type A dissections typically start in the ascending aorta and propagate distally delaminating the wall of the aorta causing a chronic weakness in the wall that in many cases degenerates into an aneurysm. The intimal flap creates <NUM> or more pathways of flow called the true (TL) and false lumen (FL). These conditions are effectively treated by surgical resection and replacement of the ascending aorta. However, the delaminated wall of the aorta is typically untreated because of the high risk associated with the additional resection of the aorta distal to the ascending segment. Additionally, the aortic arch of a patient may have variation in size, dimensions and the like. Use of stent portions for being received within the arch are thus constrained by the variations among different aortic arches.

Acute aortic dissections and intramural hematomas (IMH) are caused by an intimal tear or hemorrhage within the aortic wall. This causes delamination and propagation of the intimal flap proximally and distally. The proximal propagation of the intimal flap can cause aortic insufficiency, blockage of coronary arteries, aortic rupture and death. This is prevented by surgical replacement of the ascending aorta. Distal propagation of the intimal flap can cause blockage of important aortic side branches leading to stroke or visceral malperfusion. Typically the pressurized and perfused FL expands and causes the compression of the TL. During the acute phase of the dissection process, the tear causes inflammation of the aortic wall. If the intimal flap is reattached and supported, the inflammation will help in fusing the dissected layers and potentially allow the dissection to cure. This will encourage positive aortic remodeling and exclusion/ depressurization of the FL.

Although the technique of ascending aortic replacement has been perfected, currently there are no effective means of reattaching the dissected intimal flap to the aortic wall in the arch and beyond. To address the long term complications attributed to the FL, different devices have been designed but none have been shown to be effective. In addition, some surgeons advocated for additional resection of the aortic arch during the index operation, however the majority of surgeons are reluctant to do so due to an increase in the complexity of the operation and the mortality. Additionally, resection of the arch will not exclude the FL in the remainder of the aorta. The endovascular solutions available for treatment of aortic aneurysms are inadequate for treatment of dissections because their graft coverage fixes their diameter and won't allow for the device to expand freely to re-attach the intimal flap. In addition, the graft coverage will obstruct important aortic side branches perfusing the brain, spinal cord and viscera.

The above challenges may be overcome by the invention disclosed in this application, where the proximal reinforced section of the graft allows for a more secure and hemostatic suture line, the distal stent reinforced graft section allows for future landing zone to implant additional endografts and the intervening braided, uncovered stent portion allows tacking and stabilizing of the aortic tear and the detached intima to the remainder of the aorta without compromising blood flow to the supra-aortic branches, thereby excluding the FL and providing an opportunity for the tear to heal and to cure the dissection. <CIT> relates generally to a stent with a selectively changeable cross-sectional area which is easily inserted into and removed from a body vessel, and which is selectively expandable and releasable.

The invention relates to an assembly as defined by claim <NUM>. According to one or more embodiments, an assembly including a stent device engaged with a deployment device in an initial configuration is provided. The deployment device has a rod translatable within an aorta of a patient and having an operator end and a distal end, and a first release wire configured for releasing one or more radially constraining members constraining the diameter of the stent device. The stent device has a distal portion for being engageably received in the aortic arch of the patient and extending beyond the left subclavian artery when implanted. Further, the stent device has a stent portion fluidly engaged with the distal portion, the stent portion being at least partially permeable and configured to span a portion of the aortic arch to which the brachiocephalic trunk, left common carotid artery, and left subclavian artery attach. Additionally, the stent device includes a proximal portion fluidly engaged with the stent portion. A diameter and a length of the stent device in a deployed configuration can be altered by axial translation of the rod and releasing one or more of the radially constraining members by translation of the first release wire.

According to one or more embodiments, a method of deploying a stent device into an aorta of a patient is provided wherein a stent device is engaged about a rod of a deployment device in an initial configuration. The method includes positioning a distal portion of the stent device at least beyond the left subclavian artery by axially translating a distal end of the rod into the aorta, wherein the stent device further includes a stent portion in fluid engagement with the distal portion and a proximal portion in fluid engagement with the stent portion. The method further includes releasing one or more radially constraining members constraining a diameter of the stent portion and modifying the length and the diameter of the stent device into a deployed configuration by axially translating the rod within the aorta. Additionally, the stent portion is positioned to span and engage a portion of the aortic arch to which the brachiocephalic trunk, the left common carotid artery, and the left subclavian artery attach. Finally, the method includes removing the rod from the aorta of the patient.

The previous summary and the following detailed descriptions are to be read in view of the drawings, which illustrate particular exemplary embodiments and features as briefly described below. The summary and detailed descriptions, however, are not limited to only those embodiments and features explicitly illustrated.

These descriptions are presented with sufficient details to provide an understanding of one or more particular embodiments of broader inventive subject matters. These descriptions expound upon and exemplify particular features of those particular embodiments without limiting the inventive subject matters to the explicitly described embodiments and features. Considerations in view of these descriptions will likely give rise to additional and similar embodiments and features without departing from the scope of the inventive subject matters. Although the term "step" may be expressly used or implied relating to features of processes or methods, no implication is made of any particular order or sequence among such expressed or implied steps unless an order or sequence is explicitly stated. While the concepts of the present disclosure are susceptible to various modifications and alternative forms, specific exemplary embodiments thereof have been illustrated by way of example in the drawings and will herein be described in detail. It should be understood, however, that there is no intent to limit the concepts of the present disclosure to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.

Any dimensions expressed or implied in the drawings and these descriptions are provided for exemplary purposes. Thus, not all embodiments within the scope of the drawings and these descriptions are made according to such exemplary dimensions. The drawings are not made necessarily to scale. Thus, not all embodiments within the scope of the drawings and these descriptions are made according to the apparent scale of the drawings with regard to relative dimensions in the drawings. However, for each drawing, at least one embodiment is made according to the apparent relative scale of the drawing.

Terms representing anatomical references, such as anterior, posterior, medial, lateral, superior, inferior, distal, proximal, etcetera, may be used throughout the specification in reference to the orthopaedic implants and surgical instruments described herein as well as in reference to the patient's natural anatomy. Such terms have well-understood meanings in both the study of anatomy and the field of orthopaedics. Use of such anatomical reference terms in the written description and claims is intended to be consistent with their well-understood meanings unless noted otherwise.

Referring to <FIG>, <FIG>, <FIG>, <FIG>, an assembly <NUM> may include a deployment device <NUM> and a stent device <NUM>, which may be advantageously provided for addressing issues associated with aortic arches of various sizes and dimensions. The stent device <NUM> of the assembly <NUM> may be engaged with the deployment device <NUM> in an initial configuration <NUM>, as depicted in <FIG>. The stent device <NUM> may have a distal portion <NUM> for being engageably received in the aortic arch and descending aorta of the patient and extending beyond the left subclavian artery when implanted, as depicted in <FIG> and <FIG>. Further, the stent device <NUM> may have a stent portion <NUM> fluidly engaged with the distal portion <NUM>, the stent portion <NUM> being at least partially permeable and configured to span a portion of the aortic arch to which the brachiocephalic trunk, left common carotid artery, and left subclavian artery attach. In this manner, blood flow to each of the brachiocephalic trunk, left common carotid artery, and left subclavian artery flows through the at least partially permeable stent portion <NUM>. As depicted in <FIG>, a proximal portion <NUM> of the stent device <NUM> may also be fluidly engaged with the stent portion <NUM>.

Another unique feature of the stent <NUM> depicted in <FIG> is the tapered terminal end of the stent <NUM>. <FIG> depicts an end on the proximal portion <NUM> being tapered, but some embodiments include the distal portion <NUM>, or both portions <NUM>, <NUM>, being tapered. By designing the stent <NUM> in a tapered bottle-neck fashion, the stent <NUM> will be able to be attached to one universal size proximal or distal prosthetic components, such as a proximal graft section <NUM> or distal graft section <NUM>. The tapering will also expand the stent free areas between the crossing wires of the stent <NUM> which is important when stents <NUM> cross major aortic side branches so the blood flow to the branches remain uninhibited. The taper may be created by mechanically narrowing the terminal end of the stent <NUM> prior to attaching it to the graft component <NUM>, <NUM>. A tapered end could be manufactured in the bottle-neck fashion or it could be created laser cut in a gridded fashion.

This stent device <NUM> may be designed to be stretched and elongated, with the diameter of the stent device <NUM> varying while still retaining its structural integrity. In some embodiments, the stent device <NUM> may be capable of adjusting its length and diameter to the length and diameter of the patient aorta <NUM> irrespective of size differences between the aorta <NUM> and the stent device <NUM>. In this manner, the device <NUM> is conformable to a variety of anatomical features, dimensions, and configurations. Further, the ability for the diameter and the length to vary allows the stent device <NUM> as a whole to be stretched and elongated on the deployment device <NUM> and deployed within the aorta <NUM> while being able to conform its diameter and length to that of the patient's native aortic anatomy. Different parts of stent <NUM> are capable of adjusting the diameter of the stent <NUM> to fit the diameter of the aorta <NUM> in the location the stent <NUM> is positioned. This means the stent <NUM> in its entirety is allowed to conform itself to diameter changes of the aorta <NUM>. As an example, if a stent <NUM> with a resting diameter of <NUM> is implanted by utilizing the assembly <NUM>, the stent component <NUM> is capable of conforming its diameter to that of the aortic arch and the descending aorta even though the arch diameter is <NUM> and the descending aortic diameter is <NUM>. Conventional stents, stent grafts and assemblies are not capable of such feature. Of course the numbers mentioned in this example are just demonstrative and different ranges of diameter change in the aorta <NUM> can be accommodated by the assembly <NUM>. In some embodiments, the diameter and length of the stent device <NUM> in a deployed configuration <NUM> may be altered by axial translation of a rod <NUM> of a deployment device <NUM>, and/or by releasing one or more of the radially constraining members <NUM> by translation of the first release wire <NUM> of a deployment device <NUM> (see <FIG> for a depiction of deployment steps).

The stent device <NUM> may also be used in a modular fashion with other endovascular devices, graft sections <NUM>, <NUM> with modular components overlapping and/or engaging in some fashion to treat disease distal or proximal to the stent device <NUM>. As shown in <FIG> and <FIG>, the assembly <NUM> may include a distinct proximal graft section <NUM> engaged with the proximal portion <NUM> of the stent device <NUM>. <FIG> depicts the proximal section <NUM> including a collar <NUM> engaged with the proximal portion <NUM>, the collar <NUM> configured for being selectively engaged with the aorta <NUM> for securing the stent device <NUM> within the aorta <NUM>. Further, the collar <NUM> may define a cylindrical component <NUM> for engaging the proximal portion <NUM>. The cylindrical component may be at least <NUM> in length and can terminate at the level of the collar or extend beyond the level of the collar. This combination of collar and cylindrical component can be used with all stent and graft combinations described in <FIG>. The collar <NUM> may measure over <NUM> in diameter and can be fit to use with practically all diameters of aorta <NUM> treated. This collar <NUM> may be anastomosed to the transected aorta <NUM> and can be used similar to a washer to buttress and strengthen the connection between assembly <NUM>, aorta <NUM> and, for example, any polyester graft that the ascending aorta is typically replaced with.

Examples of other endovascular devices or stents are found in related <CIT> and titled "Device for Endovascular Aortic Repair and Method of Using the Same", now <CIT>, which is incorporated by reference herein in its entirety.

Referring to <FIG>, the assembly <NUM> may include a proximal graft section <NUM> engageable with the proximal portion <NUM> on one end and with the aorta <NUM> or another stent on another end. The collar <NUM> may be donut shaped, as illustrated or take on any appropriate shape or configuration, and may have a diameter of at least <NUM>. In some embodiments, engagement on either end of the proximal graft section <NUM> may be effectuated using stiches or sutures <NUM>. In at least one embodiment, the proximal graft section <NUM> may have a diameter of between about <NUM> and <NUM>. As is depicted in <FIG>, the proximal graft section <NUM> may define a side arm <NUM> for providing access with the proximal section <NUM> and/or stent device <NUM> for performing bypasses to the supra-aortic branches or for connecting the patient to cardiopulmonary bypass. In some embodiments the side arm <NUM> may be about <NUM> or larger in diameter The side arm <NUM> may be sewn shut in operation or omitted all together if not desired. In some embodiments, the proximal graft section <NUM> may be inverted into a portion of the stent device <NUM> for easier delivery, as illustrated in <FIG>. A stitch <NUM> may be attached to the proximal graft section <NUM> for aiding in pulling the section <NUM> out of the stent device <NUM> during or after deployment. When comparing <FIG>, one notices that when the stent device <NUM> is elongated, the diameter of the stent device <NUM> reduces. Similarly, as the length of the stent device <NUM> is shortened, the diameter increases.

The assembly <NUM> may include a distinct distal graft section <NUM> engaged with the distal portion <NUM> of the stent device <NUM>. <FIG> depicts an assembly <NUM> which does not include a distal graft section <NUM>. The distal graft section <NUM> may be engageably received in a descending aorta of a patient beyond the left subclavian artery. Similar to the proximal graft section <NUM>, the distal graft section <NUM> may serve as a docking station for modular implantation of other endovascular stents, grafts and/or devices in a modular fashion. The distal graft section <NUM> may be at least <NUM> in length and made of polyester, PTFE or any other impermeable biologically acceptable prosthetic material and may be a) unsupported, b) supported on its external or internal surface by metallic support frames and stents made of memory shape wire, stainless steel or other alloys and polymers, and/or c) be secured to the internal surface of the distal portion <NUM> of the stent device <NUM>. <FIG> depicts an unsupported distal graft section <NUM>. <FIG> illustrates a distal graft section <NUM> externally supported by a support frame <NUM>. <FIG> reveals a distal graft section <NUM> externally supported by a support frame <NUM>, which, in some embodiments, could be an extension of the distal portion <NUM> of the stent device <NUM>.

The connection between the graft sections <NUM>, <NUM> and the stent device <NUM> may be secured with stitches <NUM>, clips or mechanical fasteners. In some embodiments, the stent device <NUM> may include eyelets <NUM> on either the proximal portion <NUM> and/or distal portion <NUM> for engaging the stent device <NUM> with the graft sections <NUM>, <NUM>, or, alternatively, with an anatomical feature of the patient. For example, referring to <FIG>, the distal portion <NUM> of the stent device <NUM> may include eyelets <NUM> for engaging the aorta <NUM> or a distal graft section <NUM>. The eyelets <NUM> may be formed of a contiguous portion of the stent device <NUM>, such as the wire forming the braided stent member <NUM>. Further, the eyelets <NUM> may provide an anchor point for controlling an end of the graft <NUM>, <NUM> and/or the stent device <NUM>, as is described in more detail infra.

The stent device <NUM> and/or the graft sections <NUM>, <NUM>, or portions thereof, may be permeable or impermeable and include a prosthetic material such as polyester, polytetrafluoroethylene (PTFE) or expanded PTFE, or include other suitable biological compatible fluid impermeable material(s). The stent device <NUM> and/or the graft sections <NUM>, <NUM>, or portions thereof, may be reinforced on their external or internal surface with polymeric scaffold or stent wire scaffold such as z-stent, m-stent, circular or saddle shaped stent, laser cut stents with a gridded pattern, or a braided stent member <NUM>. Further, the stent device <NUM> may be covered with an impermeable material, such as an impermeable graft section <NUM>, <NUM>, or remain uncovered. The braided stent member <NUM> may be formed by two or more wires or wire frames, or may be formed by a single continuous braided wire frame. Alternatively, a biodegradable scaffold may allow the stent device <NUM> and/or graft sections <NUM>, <NUM> to serve its function in the aorta <NUM> until the delaminated aorta <NUM> is healed. Once the aorta <NUM> is healed, the stent device <NUM> may be auto-degraded leaving no foreign material behind. In some embodiments the proximal graft section <NUM> and/or distal graft section <NUM> may be omitted (e.g., see <FIG>).

As noted supra, the assembly <NUM> may include a deployment device <NUM> for deploying the stent device <NUM> into the aorta <NUM> of a patient. In some embodiments, the deployment device <NUM> may have a first release wire <NUM> configured for releasing one or more radially constraining members <NUM> which may be configured to constrain a diameter of the stent device <NUM> (e.g., see <FIG>, <FIG>). The deployment device <NUM> may define a first outlet <NUM> from which the first release wire <NUM> extends. The first release wire <NUM> may be configured for releasing the one or more radially constraining members <NUM> (see <FIG>). A first cap <NUM> selectively receivable by the first outlet <NUM> may be provided. The first release wire <NUM> may be engaged with the first cap <NUM> so that translation of the first cap <NUM> also translates the first release wire <NUM>.

In additional embodiments, the deployment device may also have a second release wire <NUM> configured for releasing additional one or more radially constraining members <NUM> which may be configured to constrain a diameter of the stent device <NUM>. The deployment device <NUM> may define a second outlet <NUM> from which a second release wire <NUM> extends. The second release wire <NUM> may be configured for releasing additional one or more radially constraining members <NUM>. A second cap <NUM> selectively receivable by the second outlet <NUM> may be provided. The second release wire <NUM> may be engaged with the second cap <NUM> so that translation of the second cap <NUM> also translates the second release wire <NUM>. In some embodiments, as is depicted in <FIG>, partial translation of the second release wire <NUM> may release a portion of the additional one or more radially constraining members <NUM>. Once the first and second release wires <NUM>, <NUM> are fully translated, as is illustrated in <FIG>, the entire stent device <NUM> expands to its deployed configuration <NUM>.

In other embodiments, as depicted in <FIG>, a safety pin <NUM> may extend between a first cap <NUM> selectively receivable by the first outlet <NUM> and a second cap <NUM> selectively receivable by the second outlet <NUM> such that the second cap <NUM> cannot be disengaged without first disengaging the first cap <NUM> or, alternatively, by severing the safety pin <NUM>.

Referring again to <FIG>, the one or more radially constraining members <NUM> may be configured to release a first segment <NUM> of the stent device <NUM>, and the additional one or more radially constraining members <NUM> may be configured to release a second segment <NUM> of the stent device <NUM>.

As described supra, the stent device <NUM> of the assembly <NUM> may be positioned about a rod <NUM> of the deployment device <NUM> in an initial configuration <NUM> (e.g., see <FIG>). The rod <NUM> may be translatable within an aorta <NUM> of a patient. The rod <NUM> may have an operator end <NUM> for engaging a handle assembly <NUM> of the deployment device <NUM> and a distal end <NUM> for placement within the patient. The handle assembly <NUM> may provide for axial translation of the rod <NUM>.

Referring to <FIG>, the rod <NUM> may define one or more protrusions <NUM>, <NUM>', <NUM>", <NUM>‴ extending therefrom that are spaced-apart relative to one another. These protrusions <NUM>, <NUM>', <NUM>", <NUM>‴ act to slow translation of the stent device <NUM> for controlling a deployment speed. Further, the rod <NUM> may include one or more apertures <NUM> for permitting translation of the one or more release wires <NUM>, <NUM> therethrough. As is illustrated, the deployment device <NUM> may define a third outlet <NUM> through which a guidewire <NUM> extends. The guidewire <NUM> may extend through the third outlet <NUM> and along the length of the rod <NUM> to a tip <NUM> defined by the distal end <NUM> of the rod <NUM>. The rod <NUM> may define a tip <NUM> on the distal end <NUM> that has an initially non-linear arrangement <NUM> (see <FIG>). Advancement of the guidewire <NUM> through the tip <NUM> may cause the tip <NUM> to define a linear arrangement <NUM> (see <FIG>). Additionally, the rod may define a stop member <NUM> on its distal end <NUM> for prohibiting movement of the stent device <NUM> therebeyond. <FIG> illustrates a deployment device <NUM> having a guidewire <NUM> extending distally therefrom.

As is illustrated in <FIG>, a deployment device <NUM> may include a proximal protective member <NUM> for engaging the proximal graft section <NUM> of the stent device <NUM> for constraining the expansion of the stent device <NUM> radially and protecting the graft section <NUM> when in storage or use. Additionally the proximal protective member <NUM> reduces the profile of the graft section <NUM> of the assembly <NUM>, making the introduction of the assembly <NUM> into the aorta <NUM> easier. The proximal protective member <NUM> may be removed by axially translating the member <NUM> and sliding the rod <NUM> through the transverse slit <NUM> of the member <NUM>.

<FIG> depict alternative embodiments of a deployment device <NUM> of an assembly <NUM>. As shown in <FIG>, the deployment device <NUM> may include a base <NUM> and a handle assembly <NUM>. The handle assembly <NUM> may include any of the features described herein. <FIG> illustrates one or radially constraining members <NUM> and additional one or more radially constraining members <NUM> engaged with the base <NUM> and extending therefrom. As illustrated, the radially constraining members <NUM>, <NUM> may be sheaths <NUM> having eyelets <NUM> for constraining a stent device <NUM> therewithin, as is illustrated in <FIG>.

The sheaths <NUM> may be comprised of PTFE, ePTFE, or other biologically acceptable materials. The sheath(s) <NUM> may be crescent shaped, attached at the bottom to the base <NUM> of the delivery device <NUM>. Alternatively, the sheath(s) <NUM> may be circular and embrace the base <NUM> of the delivery system <NUM>. On the upper surface the sheath(s) <NUM> may be divided by a longitudinal slit <NUM>. Each edge of the slit <NUM> may be equipped with the eyelets <NUM> for passage of the release wires <NUM>, <NUM>. After the stent device <NUM> is loaded within the sheath(s) <NUM>, the passage of release wires <NUM>, <NUM> through the eyelets <NUM> will enable the sheath(s) <NUM> to be closed for containing the stent device <NUM> therein. The sheaths <NUM> may operate independently of each other for allowing sequential deployment of the stent device <NUM>.

<FIG> illustrates the deployment device <NUM> further including a guidewire <NUM> extending from the handle assembly <NUM> along the length of the base <NUM> through a rod <NUM> to a tip <NUM>. The rod <NUM> may include any of the features described herein. For example, axial translation of the guidewire <NUM> may be effected through axial translation of the handle assembly <NUM>, thereby translating the tip <NUM> within the aorta <NUM>. The tip <NUM> may include an eyelet <NUM> or some other engagement mechanism for engaging or permitting pass through of at least one release wire <NUM>, <NUM>. The tip <NUM> may be olive shaped or may have any of the other features described herein.

<FIG> are illustrations of a guidewire <NUM> positioned within the sheaths <NUM> of a deployment device according to one or more embodiments of the present invention. <FIG> are illustrations of a deployment device <NUM> having sheaths <NUM> and a stent device <NUM> positioned therewithin for deployment within an aorta <NUM>. At least one release wire <NUM>, <NUM> engages the eyelets <NUM> of the sheaths <NUM> and the tip <NUM> for radially constraining the stent device <NUM> and permitting selective expansion thereof. <FIG> is an illustration of the entire alternative embodiment of the deployment device <NUM> as described herein. Alternatively, suture material could be used to hold the two sides of the sheath <NUM> approximated with slipknots or passing suture technique.

In order to deploy the stent device <NUM> of the assembly, the chest of a patient is opened and cardiopulmonary bypass is initiated. The body is cooled down for brain and organ protection and, once adequately cold, cardiopulmonary bypass is stopped. The ascending aorta and/or aortic arch is divided and resected. The segment proximal to the innominate artery is prepared. Deployment of the stent device <NUM> using the deployment device <NUM> of the assembly <NUM> may be now possible once the assembly <NUM> has been assembled and/or prepared.

A method of deploying a stent device <NUM> into an aorta <NUM> of a patient may comprise positioning a distal portion <NUM> of the stent device <NUM> at least beyond the left subclavian artery by axially translating a distal end <NUM> of a rod <NUM> of a deployment device <NUM> into the aorta <NUM>. The axial translation of the rod <NUM> may be provided by manipulating a handle assembly <NUM> of the deployment device <NUM>. The method of deploying a stent device <NUM> into an aorta is illustrated in <FIG> using a model aorta <NUM>. <FIG> depicts the stent device <NUM> deployed within the aorta <NUM> in an initial configuration <NUM>.

As noted supra, the stent device <NUM> may be engaged with the deployment device <NUM> in an initial configuration <NUM> about the rod <NUM>. Further, the stent device <NUM> may include a stent portion <NUM> in fluid engagement with the distal portion <NUM> and a proximal portion <NUM> in fluid engagement with the stent portion <NUM>.

In some embodiments, once the stent device <NUM> is deployed and/or appropriate positioning is confirmed, the method may include releasing one or more radially constraining members <NUM> constraining a diameter of the stent portion <NUM> of the stent device <NUM>. This release may be performed by translating a first release wire <NUM> of the deployment device <NUM>. Translating the release wire <NUM> may be performed by translating a first cap <NUM> engaged with the first release wire <NUM> and selectively engaged with a first outlet <NUM> of the deployment device <NUM>, as is depicted in <FIG>.

In other embodiments, the method of deployment may further include releasing additional one or more radially constraining members <NUM> constraining the diameter of the stent portion <NUM>. This release may be performed by translating a second release wire <NUM> of the deployment device <NUM>. Translating the second release wire <NUM> may be performed by translating a second cap <NUM> engaged with the second release wire <NUM> and selectively engaged with the second outlet <NUM> of the deployment device <NUM>.

In at least one embodiment, the one or more radially constraining members <NUM> radially constrain a first segment <NUM> of the stent portion <NUM> and the additional one or more radially constraining members <NUM> radially constrain a second segment <NUM> of the stent portion <NUM>. The release wires <NUM>, <NUM> may be translated in any order, and each cord <NUM>, <NUM> may affect any number of segments <NUM>, <NUM> or constraining members <NUM>, <NUM> arranged in any number of patterns or configurations. Each release of a constraining member <NUM>, <NUM> may alter the diameter of any number of segments <NUM>, <NUM> of the stent portion <NUM> or stent device <NUM> to best fit the stent device <NUM> to the aorta <NUM> during and/or after deployment. This allows the stent <NUM> to be deployed from a proximal to distal direction, distal to proximal direction or to start the deployment in the center of the stent <NUM> propagating proximally or distally.

In the particular embodiment shown in <FIG> the assembly <NUM> may be placed inside the aorta <NUM> and positioned with the collar <NUM> proximal to the origin of the innominate trunk. The collar <NUM> may be secured in place by stitches <NUM> or mechanical means. The first cap <NUM> may be unlocked and the release wire <NUM> may be pulled unraveling the first radially constraining members <NUM> expanding the proximal portion <NUM> of the stent component <NUM>. The second release wire <NUM> may be now released (see <FIG>) and the second radially constraining members <NUM> are unraveled one by one under the full control of the operator while the inner rod <NUM> and the handle component <NUM> may be pulled back towards the operator. By keeping the proximal part of the assembly <NUM> fixated to the aorta <NUM>, the unraveling of the second constraining members <NUM> one by one allows the translation of the inner rod <NUM> to elongate or shorten the stent component <NUM> as the radially constraining members <NUM> are unraveled thereby allowing the operator to control the functional diameter of the stent component <NUM> and match it to that of the aorta <NUM> thereby being able to treat a wide range of aortic diameters.

As depicted in <FIG>, a safety pin <NUM> may be engaged to the first cap <NUM> and the second cap <NUM>. Translating the second cap <NUM> may be enabled when the safety pin <NUM> is severed or when the first cap <NUM> is disengaged from the first outlet <NUM> (see <FIG>).

At any point during or after deployment, the method may include modifying the length and the diameter of the stent device <NUM> into a deployed configuration <NUM> by axially translating the rod <NUM> within the aorta <NUM>. For example, in <FIG>, the rod <NUM> may be translated away from the aorta <NUM> towards the operator, thereby expanding the deployed configuration <NUM> of the stent device <NUM> within the aorta <NUM>. Appropriate positioning of the stent device <NUM> may be reconfirmed at any time. Through manipulation, modification or axial translation, the stent portion <NUM> may be positioned to span and engage a portion of the aortic arch to which the brachiocephalic trunk, the left common carotid artery, and the left subclavian artery attach. For example, the method may include manipulating the proximal portion <NUM>, stent portion <NUM>, distal portion <NUM>, proximal graft section <NUM>, distal graft section <NUM>, eyelets <NUM> or any other component of the stent device <NUM> for further positioning and/or modifying the length and the diameter of the stent device <NUM> into a deployed configuration <NUM>. In some embodiments, the positioning and/or modifying of the stent device <NUM> is limited by a stop member <NUM> defined about the distal end <NUM> of the rod <NUM>.

Thus, as an example, by delivering the stent component <NUM> to the desired location in the aorta <NUM>, the proximal portion <NUM> of the assembly <NUM> is fixated and stabilized in location. This may be done by either stitching the graft collar <NUM> to the transected aorta <NUM> or by releasing the first release wire <NUM> thereby expanding the proximal portion <NUM> of the stent component <NUM> allowing the stent <NUM> to obtain apposition against the aortic wall. Once the assembly <NUM> is stable in position the second release wire <NUM> may be pulled releasing the slip joints <NUM> restraining the distal portion <NUM> of the stent <NUM> while the rod <NUM> is translated proximally or distally like an accordion, thereby changing the length and diameter of the stent component <NUM> to the desired diameter and length fitting the aorta <NUM> and thereby pushing up and reattaching the intimal flap to the aortic wall.

In some embodiments, once the stent device <NUM> has been inserted into the aorta (<FIG>), the first release wire <NUM> has been translated to expand a first segment <NUM> of the stent device <NUM> (<FIG>) and the rod <NUM> has been translated to fully deploy the first segment <NUM> within the aorta (<FIG>), the second release wire <NUM> may be translated to begin expansion of the second segment <NUM> of the stent device <NUM> (<FIG>). Before fully translating the second release wire <NUM>, the rod <NUM> may again be translated to expand and position the stent device <NUM> within the aorta (<FIG>). Subsequently, the second release wire <NUM> may be fully translated, thereby expanding the entire second segment <NUM> of the stent device <NUM> (<FIG>). The guidewire <NUM> may then be translated to configure the tip <NUM> into a linear arrangement <NUM> for removing the rod <NUM> from within the stent device <NUM> and aorta <NUM> (<FIG>). <FIG> depicts a fully deployed stent device <NUM> within the model aorta <NUM>.

Once the stent device <NUM> is deployed and/or positioned, the method may include removing the rod <NUM> from the aorta <NUM> of the patient. Removal may be performed by axially translating the rod <NUM> directly or by using the handle assembly <NUM>. To ensure safe removal of the deployment device <NUM> from the aorta <NUM>, a guidewire <NUM> may be translated to position the tip <NUM> into a linear arrangement <NUM>. The method may further include advancing a guidewire <NUM> extending through a third outlet <NUM> of the deployment device <NUM> through a tip <NUM> defined by the distal end <NUM> of the rod <NUM>, causing the tip <NUM> to change from a non-linear arrangement <NUM> to a linear arrangement <NUM>. In some embodiments, the tip <NUM> may be pushed distally to fully disengage the stent device <NUM> for removal of the deployment device <NUM> from the aorta <NUM>.

For embodiments of the assembly <NUM> including a collar <NUM> engaged to the proximal portion <NUM>, the method may include attaching the collar <NUM> to the aorta <NUM> or another stent. For embodiments of the assembly <NUM> including a distal portion <NUM> of the stent device <NUM>, the method may include attaching the distal portion <NUM> to the aorta <NUM>, a distal graft section <NUM> or another stent. The attachment of the proximal portion <NUM> or the distal portion <NUM> may be performed prior to radial expansion of the stent device <NUM>, prior to final deployment of the stent device <NUM>, or after final deployment of the stent device <NUM>.

As disclosed herein, the stent device <NUM> may be deployed independent from graft sections <NUM>, <NUM>, i.e. the operator will open the aorta <NUM> as described supra and deploy the stent device <NUM> into the aortic arch and the descending aorta to reattach the dissection flap. Once the stent device <NUM> is delivered to its intended location, a polyester proximal graft section <NUM> may be used as a unique separate entity, the distal end of which is anastomosed to the aortic arch at or near the j unction of the attachment of the stent. The proximal end of the proximal graft section <NUM> may be anastomosed to the sinutubular junction or a valved conduit. This effectively replaces the ascending aorta. As yet another embodiment, the stent device <NUM> may be implanted over a deployment device <NUM> where the stent device <NUM> is unsheathed during deployment. This may entail removing a protective sheath(s) <NUM> to uncover the stent <NUM> and allow it to expand. Alternatively a conventional sheathed delivery device may be used. The proximal, stent and/or the distal portions <NUM>, <NUM>, <NUM> of the stent device <NUM> may be captured by a release mechanism(s) <NUM>, <NUM>, <NUM>, <NUM> that control accurate and sequential release of the stent.

To control the release of the stent device <NUM> and reduce the profile of the stent device <NUM> on the deployment device <NUM>, the stent device <NUM> may be mounted and stretched over the rod <NUM> and stabilized and bound using release wires <NUM>, <NUM>, which may be comprised of Tevdek (or other) suture material, effectively creating multiple restraining points. In other embodiments, one or more longitudinal release wires <NUM>, <NUM> may be used and slipknots are created to hold the stent device <NUM> onto the rod <NUM>. The slipknots may jump to the next holding position at regular intervals. Depending on the start and the direction of positioning of the slipknots, the stent device <NUM> may be deployed in multiple combinations of directions, i.e. proximal to distal, distal to proximal or from the middle of the hybrid graft. If two or more release wire <NUM>, <NUM> systems with independent slipknots are used, then different parts of the stent device <NUM> may be unwrapped and expanded independent of each other and in different directions.

A terminal end of the release wires <NUM>, <NUM> may be attached to a cap <NUM>, <NUM> that screws or otherwise selectively engages into outlets <NUM>, <NUM> for safety. Once the operator is satisfied with the positioning of the stent device <NUM>, the cap(s) <NUM>, <NUM> may be unscrewed, released, and translated. The attached release wire(s) <NUM>, <NUM> may be pulled to release and expand the braided portion of the stent device <NUM>.

The combination of the stent device <NUM> and the deployment device <NUM> including the described slipknots allows very unique properties that include that the operator is in full control of the length and diameter of the stent device <NUM>. Conventional grafts and stent grafts by virtue of their graft material are fixed in length and diameter. In contrast, the stent device described herein can be elongated or shortened thereby decreasing or increasing its diameter. Thus by sequential stepwise unwrapping of the radially constraining members <NUM>, <NUM>, one end of the stent device will be allowed to expand first reaching the maximum diameter of the aorta <NUM> and become fixed in place. At this stage the operator is able to manipulate and position various portions of the stent device <NUM> and/or deployment device <NUM> proximally or distally by axially translating the deployment device <NUM> while in a controlled fashion pulling on the release wire and unraveling the constraining member <NUM>, <NUM>, actively adjusting the diameter and length of the stent device <NUM> to that suitable for the particular aortic dimension that is being treated. The obvious advantages of this technology is the in-vivo fitting of the stent device <NUM> to the aortic anatomy, and only one or two sizes of the stent device may be needed to accommodate the majority of aortic dimensions in patients.

As illustrated in <FIG>, the tip <NUM> capable of both a non-linear arrangement <NUM> and linear arrangement <NUM> permits the atraumatic introduction of the stent device <NUM> into the aorta <NUM>. Once the stent device <NUM> is deployed, the curled tip <NUM> may be straightened into a linear arrangement <NUM> as the deployment system is being retracted from the aorta <NUM>, thereby avoiding entanglement with the stent device <NUM> or aorta <NUM>. The tip <NUM> may be hollow with a guidewire <NUM> that is continuous and passing through the center of the deployment device <NUM>. Passage of the guidewire <NUM> may also reconfigures the tip <NUM> from the initially non-linear arrangement <NUM> to the linear arrangement <NUM> for smooth delivery of the stent device <NUM>. The guidewire <NUM> may terminate just distal to the handle assembly <NUM> where the guidewire <NUM> can enter or exit the deployment device <NUM> through a third outlet <NUM>. In addition the tip <NUM> can be used to inject contrast into the aorta <NUM> using the guidewire <NUM>. This enables the operator to perform angiograms while deploying the stent device <NUM> rather than using a separate angiographic catheter.

In some embodiments, the stent device <NUM> may have a diameter in an initial configuration <NUM> of <NUM> when the length of the stent device <NUM> is <NUM>. In such an embodiment, the stent device <NUM> may stretch to <NUM>, therefore reducing the diameter to <NUM>. Such properties are useful for treatment of various aortas <NUM> with different diameters. By using the assembly <NUM> described in this document, the operator will have the ability to fully control the length and diameter of the stent device <NUM> to match the anatomies of most patients' aorta <NUM>. This offers a tremendous flexibility for patient treatment and only one or two sizes of stent devices <NUM> may be required to match the anatomy of the patient population. In addition, deploying the stent device <NUM> on one end allows fixation of one end of the stent device <NUM>. Once one end of the stent device <NUM> is fixed the memory shape wire of the stent <NUM> and the inertia in the stent <NUM> will pull back the remainder of the stent <NUM> and shorten it thereby increasing the diameter of the stent <NUM>. The expansion of the stent <NUM> will only stop once the outer surface of the stent contacts the aortic wall and is therefore inhibited from further expansion. This "auto-sizing" and expansion feature is responsible for lifting and tacking the intimal flap of the dissection and fuse it back to the wall of the aorta <NUM>. Similarly the stent <NUM> expansion may be mechanically assisted by pulling back on the rod <NUM> of the deployment device <NUM> prior to fully releasing the stent device <NUM>. This system also allows the operator to lengthen and reduce the diameter of the stent <NUM> by translating the rod <NUM> in the opposite direction along the central axis of the stent <NUM> and the aorta <NUM>.

It will be appreciated that the devices and methods described herein have broad applications. The foregoing embodiments were chosen and described in order to illustrate principles of the methods and apparatuses as well as some practical applications. The preceding description enables others skilled in the art to utilize methods and apparatuses in various embodiments and with various modifications as are suited to the particular use contemplated. In accordance with the provisions of the patent statutes, the principles and modes of operation of this disclosure have been explained and illustrated in exemplary embodiments.

It is intended that the scope of the present methods and apparatuses be defined by the following claims. However, it must be understood that this disclosure may be practiced otherwise than is specifically explained and illustrated without departing from its scope It should be understood by those skilled in the art that various alternatives to the embodiments described herein may be employed in practicing the claims without departing from the scope as defined in the following claims.

Claim 1:
An assembly (<NUM>) comprising:
a deployment device (<NUM>) having:
a rod (<NUM>) translatable within an aorta of a patient and having an operator end and a distal end;
a first release wire (<NUM>) configured for releasing one or more radially constraining members (<NUM>; <NUM>), and
an uncovered stent device (<NUM>) engaged with the deployment device (<NUM>) in an initial configuration, the stent device (<NUM>) comprising:
a distal portion (<NUM>) for being engageably received in the aortic arch of the patient and extending beyond the left subclavian artery when implanted;
a stent portion (<NUM>) fluidly engaged with the distal portion (<NUM>), wherein the stent portion is a braided stent member (<NUM>),
wherein the stent portion (<NUM>) is at least partially permeable and is configured to span a portion of the aortic arch to which the brachiocephalic trunk, left common carotid artery, and left subclavian artery attach when implanted in the aortic arch, such, that blood flows through the stent portion (<NUM>) to each of the brachiocephalic trunk, left common carotid artery, and left subclavian artery;
a proximal portion (<NUM>) fluidly engaged with the stent portion (<NUM>);
wherein the stent device (<NUM>) includes a collar (<NUM>) engaged with the proximal portion (<NUM>), the collar (<NUM>) configured for being selectively engaged with the aorta and formed of a graft material;
wherein the radially constraining members (<NUM>; <NUM>) are configured to constrain a diameter of
the stent device (<NUM>),
wherein a diameter and a length of the stent device (<NUM>) in a deployed configuration can be altered by axial translation of the rod (<NUM>) and releasing one or more of the radially constraining members (<NUM>; <NUM>) by translation of the first release wire (<NUM>).