Vessel lining device and related methods

A deployment device for lining a vessel having a housing having a proximal end and a distal end opposite the proximal end, the housing defining a guidewire channel, a tube elongated along a longitudinal axis, the tube having a proximal end and a distal end spaced from the proximal end of the tube along the longitudinal axis, a sheath assembly having a hub removably coupled to the distal end of the housing, and a mesh removably coupled to the tube and positioned along the tube. The tube and the sheath assembly are configured to move along the guidewire and into the vessel through a puncture and release the mesh inside the vessel when at least one of the tube and the mesh is actuated. The device is used as a method of mitigating potential injury or harm to the integrity of the patient's vessel lining.

TECHNICAL FIELD

The present disclosure relates to devices and methods for lining a vessel.

BACKGROUND

Percutaneous procedures often involve accessing vasculature with elongated instruments, e.g., catheters, deployed in an ordered sequence. Common vasculature access points for such procedures include the femoral artery in a patient's groin area and the radial artery in the patient's forearm, each of which provides direct access to the central vasculature system, including the central venous system. For vascular procedures entry into the femoral arteries involves using a hollow needle to poke through a patient's skin, subcutaneous tissue and targeted vessel wall, thereby creating a puncture hole through each layer. After the needle poke, a guidewire is inserted through the needle until a distal end of the guidewire passes through the puncture hole and protrudes into the vessel lumen. From this puncture, all interventional equipment is then advanced into the artery to complete the operation.

As a result of these procedures, the inner lining of the vessel wall is exposed to various surgical equipment within the vessel. The vessel wall is therefore at risk to be damaged from the placement and advancement of these instruments. Potential complications can range from micro-scratching/tearing of the vessel walls to the unintentional dislodging of calcium or clots. These issues can lead to further complications during or after the surgical procedure.

SUMMARY

There is a need to provide better protection inside a vessel during surgical procedures in the vessel. An embodiment of the present disclosure is a deployment device configured to line a vessel. The deployment device includes a housing having a proximal end and a distal end opposite the proximal end, the housing defining a guidewire channel that extends from the distal end of the housing toward the proximal end. The deployment device further includes a tube elongated along a longitudinal axis. The tube has a proximal end and a distal end spaced from the proximal end of the tube along the longitudinal axis. The deployment device further includes a sheath assembly having a hub removably coupled to the distal end of the housing such that the housing is removable from the sheath assembly; and a mesh removably coupled to the tube and being positioned along the tube. At least one of the tube and the mesh are movable along the longitudinal axis in order to de-couple the mesh from the tube.

Another embodiment of the present disclosure is a method of lining a vessel. The method includes inserting a guidewire into the vessel through a puncture in the vessel. The method further includes sliding a deployment device along the guidewire and into the vessel until a distal end of the deployment device is inside the vessel. The method further includes actuating at least one of a tube and a mesh positioned along the tube to cause a lock to release the mesh from the distal end of the deployment device such that the mesh expands inside the vessel. The method further includes removing the tube from within the mesh in the vessel while maintaining the mesh in the vessel.

A further embodiment of the present disclosure is a deployment device configured to line a vessel. The deployment device includes a housing having a proximal end a distal end opposite the proximal end, and a guidewire channel that extends from the proximal end to the distal end of the housing. The deployment device further includes a tube extending relative to the housing in a distal direction. The deployment device further includes a sheath assembly having a hub removably coupled to the distal end of the housing, and a mesh removably coupled to the tube. The mesh is positioned along the tube in a compressed state. The deployment device further includes a lock that removably couples the mesh to the tube. The lock is configured to release the mesh from the tube.

A further embodiment of the present disclosure is a deployment device configured to line a vessel. The deployment device includes a housing having a proximal end, a distal end opposite the proximal end, and a guidewire channel that extends from the proximal end to the distal end of the housing. The deployment device further includes an inner tube extending relative to the housing in a distal direction. The deployment device further includes an outer tube extending relative to the housing in a distal direction and configured to surround the inner tube. The deployment device further includes a sheath assembly. The sheath assembly includes a hub removably coupled to the distal end of the housing. The sheath assembly further includes a mesh removably coupled to the outer tube, the mesh being positioned along the outer tube in a compressed state and configured to release from the outer tube when moved. The deployment device further includes a lock that removably couples the mesh to the outer tube and is configured to transition from a locked position to an unlocked position.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

As shown inFIGS.1and3, embodiments of the present disclosure include a deployment device100configured for use inside a vessel. The deployment device100is used to line an interior of a vessel in a patient's body during a surgical procedure performed by a user. The deployment device100may be actuated by the user in various ways to line the interior of the vessel, as further explained below.

Referring toFIGS.1and3, an exemplary deployment device includes a housing assembly104, a sheath assembly108having a mesh112, an actuator116and a tube120coupled to the housing assembly104. The deployment device extends along a central axis A and has a first end124, where the housing assembly104is positioned, and a second end128opposite the first end124along the central axis A, where the tube120and sheath assembly108are positioned.

The housing assembly104is configured to allow a user to manipulate the deployment device100with the user's hands and insert the deployment device100into a patient's vessel via a puncture site. The housing assembly104has a proximal end132and a distal end136opposite the proximal end132. The interior of the housing assembly104is sized to permit a guidewire (not depicted) to pass therethrough to insert the deployment device100into the vessel. The housing assembly104is operably coupled to the tube120at the distal end136. In addition, the housing assembly104is removably coupled to the sheath assembly108at the distal end136.

The sheath assembly108includes the mesh112and a hub114removably coupled to the distal end136of the housing assembly104. In the illustrated embodiment, the mesh112is positioned along the tube120. The mesh112is configured to be compressed against the tube120when the deployment device100is inserted into the vessel, and expand inside the vessel when released or decoupled from the tube120. The mesh thus lines the interior of the vessel when it is released. In its compressed state, the mesh112surrounds the tube120and is removably coupled to the hub114and to the tube120. In the illustrated embodiment, the inner diameter of the mesh112when compressed against the tube120is 7 French (“FR”), or approximately 1 mm. In other embodiments, the inner diameter of the mesh112may vary. In the illustrated embodiment, the inner diameter of the mesh112when expanded is sized to conform or contact the vessel. In alternative embodiments, the inner diameter of the mesh112when expanded may vary. The mesh112must be comprised of a flexible material in order to be compressed around the tube120and also expand to line the interior of the vessel. However, the mesh112must also be strong enough to protect the interior vessel from the insertion and removal of various equipment. In the illustrated embodiment, the mesh112is made of nitinol. In alternative embodiments, the mesh112may be made of various materials, including stainless steel, other metallic alloys, nylon, polyurethane, or other polymers.

The actuator116is configured to extend the tube120in a distal direction from a first position to a second position that is distal to the first position along the central axis A when the actuator116is engaged, thereby releasing the mesh112from the tube120and into the vessel. The actuator116is coupled to the proximal end132of the housing assembly104. The actuator116is also operably coupled to the tube120. In the illustrated embodiment, the actuator is a release lever; however, in alternative embodiments, the type of actuator may vary. The release lever rotates about the y-axis, which causes a transfer of rotational motion of the lever to translational motion of the tube120in the distal direction about the perpendicular x-axis. The tube120extends in a distal direction along the central axis A. The movement of the tube120releases the compressed mesh112.

The tube120is configured to be inserted inside the vessel via the puncture site and is further configured to transport the mesh112inside the vessel. The tube120is sized to permit a guidewire (not depicted) to pass therethrough. The tube120is elongated along the central axis A and has a proximal end140and a distal end144. The tube120has a length that extends from the proximal end140to the distal end144along the central axis A. In the illustrated embodiment, the length of the tube can vary as clinically required. In alternative embodiments, the length of the tube120may vary. The proximal end140of the tube120is coupled to the distal end136of the housing assembly104.

Referring toFIGS.2and4, the distal end144of the tube120includes a lock148and a tip152. In the illustrated embodiment, the lock148is configured to transition between a locked position and an unlocked position when the tube120is actuated by the actuator116. In the illustrated embodiment, the mesh112is fixed to the tube120in the locked position, and the mesh112is not fixed to the tube120in the unlocked position. The lock148is configured to hold the mesh112in a compressed state against the distal end of the tube120when the lock148is in the locked position. The lock148is further configured to release the mesh from the distal end of the tube when the lock is in the unlocked position. In the illustrated embodiment, the lock148is a metallic ring. In alternative embodiments, the shape and composition of the lock148may vary.

The lock148is positioned on a portion of the tip152. The tip152is sized and shaped to be inserted smoothly into the vessel and allow the lock148to transition from a locked position to an unlocked position. In the illustrated embodiment, a distal portion of the tip152is conical in shape. In another embodiment, the distal portion of the tip152may be round in shape. In alternative embodiments, the shape of the tip152may vary. In the present disclosure, the tip152includes a proximal surface156, a protrusion160located in a distal direction along the central axis A from the proximal surface156, and a distal stop surface164located in a distal direction along the central axis A from the proximal surface156and the protrusion160. The protrusion160is therefore positioned between and spaced from the proximal surface156and the distal stop surface164. The proximal surface156and protrusion160are separated by a proximal groove168. Similarly, the distal stop surface164and the protrusion160are separated by a distal groove268.

The lock is disposed between the proximal surface156and the distal stop surface164. The distal stop surface164is sized to prevent the lock148from advancing over the tip152. In the present disclosure, the diameter of the distal stop surface164is larger than the diameter of the lock148to stop the lock148from moving past the distal stop surface164in the distal direction. The proximal surface156tapers in a distal direction toward the proximal groove168and the protrusion160to aid in insertion of the tip into the patient's vessel.

The lock148is positioned on the protrusion160and compresses the mesh112against the protrusion160in the locked position. The lock148is released from the protrusion160and moves in the proximal direction toward the proximal surface156in the unlocked position. The diameter of the tube120is sized to stop the lock148from advancing past the proximal surface156in the proximal direction, and the lock148is displaced into the proximal groove168. Upon release of the lock148from the protrusion160, the lock148releases the mesh112from the tube120. The lock148transitions from the locked position to the unlocked position when the actuator116(not depicted) actuates the tube120to extend in a distal direction along the central axis A.

FIGS.1and2illustrate the deployment device100prior to engagement of the actuator116. Prior to engagement of the actuator116, the lock148is in the locked position. The mesh112surrounds the tube and is compressed between the lock148and the protrusion160at the distal end144of the tube120. This configuration allows the deployment device100to be compact in order to be inserted into the patient's vessel.FIGS.3and4illustrate the deployment device shown inFIGS.1-2, upon engagement of the actuator116. In the illustrated embodiment, rotation of the actuator116about the y-axis causes translational motion of the tube120in the distal direction about the x-axis. Rotation of the actuator116causes the tube120to extend in a distal direction along the central axis A. Extension of the tube120transitions the lock148from the locked position on the protrusion160to the unlocked position on the proximal groove168, thereby releasing the compressed mesh112from the tube120. The mesh112then expands in the vessel to line the interior of the vessel.

FIG.5is a perspective view of a deployment device500according to another embodiment of the present disclosure. The deployment device500includes the same housing assembly104, tube120, and sheath assembly108of the deployment device100shown inFIGS.1-4and described above. Therefore, the features and functionalities disclosed above for the deployment device100apply to the deployment device500shown inFIG.5and will have the same reference numbers. Referring toFIG.5, in the illustrated embodiment, the actuator516is a screw having a screw head517and a threaded body518that is configured to be rotated by a user about the x-axis. The screw516is positioned such that the screw head517is disposed on the outer surface of the housing assembly104and at least a portion of the threaded body518is disposed within the housing assembly104. The threaded body518is operably coupled to the tube120inside the housing assembly104.

When a user rotates the screw516about the x-axis via the screw head517, the threaded body518of the screw516provides translational movement of the tube120about the same axis. Rotation of the screw516therefore extends the tube120in the distal direction along the central axis A. Extension of the tube120transitions the lock148from the locked position on the protrusion160to the unlocked position off of the protrusion160and in the proximal groove168, thereby releasing the compressed mesh112. The mesh112then expands in the patient's vessel to line the interior of the vessel.

FIG.6is a perspective view of a deployment device600according to another embodiment of the present disclosure. The deployment device600includes the same housing assembly104, tube120, and sheath assembly108of the deployment device100shown inFIGS.1-4and described above. Therefore, the features and functionalities disclosed above for the deployment device100apply to the deployment device600shown inFIG.6and will have the same reference numbers. Referring toFIG.6, in the illustrated embodiment, the actuator616is a button coupled to a spring (not depicted) that is configured to be depressed by a user about the x-axis. The button616is disposed on the outer surface of the housing assembly104and the spring is disposed within the housing assembly104. The spring is operably coupled to the tube120inside the housing assembly104.

When a user depresses the button616about the x-axis, the spring transfers compressive energy from the depression of the button616into translational movement in the tube120about the same axis. Depression of the button616extends the tube120in the distal direction along the central axis A. Extension of the tube120transitions the lock148from the locked position on the protrusion160to the unlocked position off of the protrusion160and in the proximal groove168, thereby releasing the compressed mesh112. The mesh112then expands in the patient's vessel to line the interior of the vessel.

FIG.7is a perspective view of a deployment device700according to another embodiment of the present disclosure. The deployment device700includes the same housing assembly104, tube120, and sheath assembly108of the deployment device100shown inFIGS.1-4and described above. Therefore, the features and functionalities disclosed above for the deployment device100apply to the deployment device700shown inFIG.7and will have the same reference numbers. Referring toFIG.7, in the illustrated embodiment, the actuator716is a pin coupled to a spring (not depicted) that is configured to be displaced by a user about the z-axis. The pin716is disposed on the outer surface of the housing assembly104and the spring is disposed within the housing assembly104. The spring is operably coupled to the tube120and is oriented about the x-axis.

Prior to displacement of the pin716, the spring is in a compressed state. When a user displaces the pin716about the z-axis, the spring is released about the x-axis, providing translational movement of the tube120in the distal direction about the x-axis. Displacement of the pin716extends the tube120in the distal direction along the central axis A. Extension of the tube120transitions the lock148from the locked position on the protrusion160to the unlocked position off of the protrusion160and in the proximal groove168, thereby releasing the compressed mesh112. The mesh112then expands in the patient's vessel to line the interior of the vessel.

FIG.8is a perspective view of a deployment device800according to another embodiment of the present disclosure. The deployment device800includes the same housing assembly104, tube120, and sheath assembly108of the deployment device100shown inFIGS.1-4and described above. Therefore, the features and functionalities disclosed above for the deployment device100apply to the deployment device800shown inFIG.8and will have the same reference numbers. Referring toFIG.8, in the illustrated embodiment, the actuator816is a tab configured to be moved in a distal direction along a track817about the x-axis. The tab816and track817are disposed on the outer surface of the housing assembly104and are both coupled to the tube120. The track817comprises at least one ridge along the track to prevent the tab816from progressing along the track817in a proximal direction.

When a user progresses the tab816along the track817about the x-axis, the tab816and track817provide translational movement of the tube120in the distal direction about the same axis. Extension of the tube120transitions the lock from the locked position on the protrusion160to the unlocked position off of the protrusion160and in the proximal groove168, thus releasing the compressed mesh112. The mesh112then expands in the patient's vessel to line the interior of the vessel. When the tab816is progressed over the at least one ridge, the tab816locks in the current position, preventing the tab816from progressing in the proximal direction and preventing translational movement of the tube120in a proximal direction about the x-axis.

FIG.9is a perspective view of a deployment device900according to another embodiment of the present disclosure. The deployment device900includes the same housing assembly104, tube120, and sheath assembly108of the deployment device100shown inFIGS.1-4and described above. Therefore, the features and functionalities disclosed above for the deployment device100apply to the deployment device900shown inFIG.9and will have the same reference numbers. Referring toFIG.9, in the illustrated embodiment, the actuator916is a gear coupled to a track system (not depicted) that is configured to be rotated by a user about the y-axis. The gear916is disposed on the outer surface of the housing assembly104while the track system is disposed in the interior of the housing assembly104. The track system is coupled to the tube120.

When a user rotates the gear916about the y-axis, the track system provides translational movement of the tube120in the distal direction about the x-axis. The tube120extends in a distal direction along the central axis A, causing the lock148to transition from the locked position on the protrusion160to the unlocked position off of the protrusion160and in the proximal groove168, thereby releasing the compressed mesh112. The mesh112then expands in the patient's vessel to line the interior of the vessel.

FIGS.10A-10Dillustrate the deployment device100shown inFIGS.1-4, as the deployment device100is inserted and releases the mesh112in a vessel102. Referring toFIG.10A, a guidewire106is inserted into a puncture site110of the vessel102. In the illustrative embodiment, the guidewire106is fed through the tip152of the deployment device. In alternative embodiments, the deployment device100may be placed onto the guidewire106by any means known in the art. At this stage, the actuator116is not engaged. The mesh112surrounds the tube120and is compressed against the protrusion160by the lock148.

Referring toFIG.10B, the deployment device100is inserted into the vessel102through the puncture site110. At this stage, the actuator116is not engaged, and the mesh112remains compressed between the lock148and the protrusion160. The deployment device100is progressed into the vessel102until the hub114contacts the patient's skin118.

Referring toFIG.10C, the actuator116can be engaged by the user once the hub114contacts the patient's skin118. Engagement of the actuator116causes the tube120to extend in a distal direction along the central axis A past its original position. Extension of the tube120in the distal direction releases the lock148from its position on the protrusion160and causes the lock148to fall in the proximal groove168. Movement of the lock148releases the mesh112, which causes the mesh112to expand inside the vessel102. The mesh112is configured to expand to line the interior of the vessel102.

Referring toFIG.10D, the deployment device100is uncoupled from the sheath assembly108and is removed from the vessel102. The hub114remains in contact with the patient's skin118over the puncture site110and the mesh112remains inside the vessel so that the remainder of the procedure can be completed. The hub114and the mesh112may be subsequently removed upon completion of the procedure and the puncture site110may subsequently be sealed.

FIG.11is a side view of a deployment device1100according to another embodiment of the present disclosure. The deployment device1100includes the same housing assembly104, tube120, actuator116, and hub114of the deployment device100shown inFIGS.1-4and described above. Therefore, the features and functionalities disclosed above for the deployment device100apply to the deployment device1100shown inFIG.11and will have the same reference numbers. Referring toFIG.11, the deployment device further includes a mesh1112and a lock148. The mesh1112is configured to be compressed against the tube120when the deployment device1100is inserted into a patient's vessel, and expand inside the vessel when released from the tube120. The mesh thus lines the interior of the vessel when it is released. In its compressed state, the mesh1112surrounds the tube120and is removably coupled to the hub114and to the tube120. The mesh1112is operably coupled to the actuator116.

The distal end144of the tube120includes the lock1148. The lock1148is configured to hold the mesh1112in a compressed state against the tube120in a locked position prior to engagement of the actuator116. The lock1148is disposed on a portion of the tip152. The lock1148is positioned on the protrusion160and compresses the mesh1112against the protrusion160prior to engagement of the actuator116. This configuration allows the deployment device1100to be compact in order to be inserted into the patient's vessel. Once the deployment device1100is inserted into the patient's vessel, the actuator116may be engaged.

In the illustrated embodiment, engagement of the actuator116about the x-axis causes translational motion of the mesh1112in the x-axis. For example, rotation of the actuator116causes the mesh1112to retract in a proximal direction along the central axis A. Retraction of the mesh1112releases the mesh1112from beneath the lock1148. The mesh1112then expands in the vessel to line the interior of the vessel. In the illustrated embodiment, retraction of the mesh1112causes the lock1148to be transition from the locked position on the protrusion160to an unlocked position on the proximal groove168. In alternative embodiments, the lock may stay in place on the protrusion160when the mesh1112retracts.

FIG.12is a side view of a deployment device1200according to another embodiment of the present disclosure. The deployment device1200includes the same housing assembly104, actuator116, and hub114of the deployment device100,1100shown inFIGS.1-4,11and described above. Therefore, the deployment device100,1100and the deployment device1200shown inFIG.12and will have the same reference numbers. Referring toFIG.12, the deployment device further includes an inner tube1221and an outer tube1222that surrounds the inner tube1221. The inner tube1221and the outer tube1222are hollow tubes and are concentric to each other.

The inner tube1221and the outer tube1222are configured to be inserted inside the vessel via the puncture site. The inner tube1221is sized to permit a guidewire (not depicted) to pass therethrough. The inner tube1221therefore has a diameter of approximately 6 FR, while the outer tube1222has a diameter of approximately 8 FR. The inner tube1221and outer tube1222are elongated along the central axis A and have a proximal end1240and a distal end1244. The inner tube1221and the outer tube1222have a length that extends from the proximal end1240to the distal end1244along the central axis A. The proximal end1240is coupled to the distal end136of the housing assembly104. The distal end1244tapers in a distal direction and includes a screw insert1250.

The deployment device1200further includes a tip1252. The tip1252is sized and shaped to be inserted smoothly into the vessel. In the illustrated embodiment, a distal portion of the tip1252is conical in shape. In another embodiment, the distal portion of the tip1252may be round in shape. In alternative embodiments, the shape of the tip1252may vary. In the present disclosure, the tip1252includes a screw head1251located in a proximal direction along the central axis A, a protrusion1260located in a distal direction along the central axis A from the screw head1251, and a distal stop surface1264located in a distal direction along the central axis A from the screw head1251and the protrusion1260. The protrusion1260is therefore positioned between and spaced from the screw head1251and the distal stop surface1264. The screw head1251and protrusion1260are separated by a proximal groove1268. Similarly, the distal stop surface1264and the protrusion1260are separated by a distal groove1269.

The tip1252is configured to be attached to the inner tube1221and the outer tube1222. Specifically, the screw head1251is configured to be inserted into the screw insert1250. The tip1252includes a hollow channel that extends along the length of the tip1252to allow a guidewire to pass through both the tip1252and the inner tube1221when the tip1252and the inner tube1221and outer tube1222are attached.

The deployment device1200further includes a mesh1212. The mesh1212is configured to be compressed against the outer tube1222when the deployment device1200is inserted into a patient's vessel, and expand inside the vessel when released from the outer tube1222. The mesh thus lines the interior of the vessel when it is released. In its compressed state, the mesh1212surrounds the outer tube1222and is removably coupled to the hub114and to the outer tube1222. The mesh1212is operably coupled to the actuator116.

The deployment device1200further includes a lock1248. The lock1248is configured to hold the mesh1212in a compressed state against the outer tube1222in a locked position prior to engagement of the actuator116. The lock1248is disposed on a portion of the tip1252. The lock1248is positioned on the protrusion1260and compresses the mesh1212against the protrusion1260prior to engagement of the actuator116. This configuration allows the deployment device1200to be compact in order to be inserted into the patient's vessel. Once the deployment device1200is inserted into the patient's vessel, the actuator116may be engaged.

In the illustrated embodiment, engagement of the actuator116about the y-axis causes translational motion of the mesh1212in the x-axis. For example, rotation of the actuator116causes the mesh1212to retract in a proximal direction along the central axis A. Retraction of the mesh1212releases the mesh1212from beneath the lock1248. The mesh1212then expands in the vessel to line the interior of the vessel. In the illustrated embodiment, retraction of the mesh1212causes the lock1248to transition from the locked position on the protrusion1260to an unlocked position on the distal groove1269. In alternative embodiments, the lock may stay in place on the protrusion1260when the mesh1212retracts.

Now referring toFIG.13, a method1300for lining a patient's vessel using the deployment device100,1100,1200shown inFIGS.1-4, and10A-12will be described. In step1304, a guidewire106is inserted through a puncture site110of a patient's vessel102. The guidewire106passes through the puncture site110and protrudes into the vessel lumen. In step1308, the second end128of the deployment device100,1100,1200is placed onto the proximal end of the guidewire106via the tip152,1252and the deployment device100,1100,1200is slid along the guidewire106. In step1312, the deployment device100,1100,1200is progressed further along the guidewire106until a distal end of the deployment device100,1100,1200has entered the patient's vessel tract. The deployment device100,1100,1200is progressed along the guidewire106and into the patient's vessel tract until the hub114is in contact with the patient's skin. In step1316, when the hub114is in contact with the patient's skin, the actuator116actuates at least one of the tube120and the mesh112,1112,1212. In step1320, the lock148,1148,1248releases the mesh112,1112,1212from the tube120,1222such that the mesh112,1112,1212expands inside the vessel to line the interior of the vessel. In step1324, the housing assembly104and the tube120,1221,1222of the deployment device100,1100,1200is removed from the vessel, leaving behind the mesh112,1112,1212and guidewire106inside the vessel, as well as the hub114in contact with the patient's skin118. The remainder of the surgical procedure may then be completed before the mesh112,1112,1212the hub114, and the guidewire106are removed, and the puncture site110is subsequently sealed.

The present disclosure is described herein using a limited number of embodiments, these specific embodiments are not intended to limit the scope of the disclosure as otherwise described and claimed herein. Modification and variations from the described embodiments exist. More specifically, the following examples are given as a specific illustration of embodiments of the claimed disclosure. It should be understood that the invention is not limited to the specific details set forth in the examples.