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Title:
CONTROLLABLE OCCLUSION WITH PERFUSION DEVICE FOR USE DURING RADIAL ACCESS VASCULAR INTERVENTION PROCEDURES
Document Type and Number:
WIPO Patent Application WO/2023/034873
Kind Code:
A1
Abstract:
Temporary vascular occlusion devices and methods for use thereof are described which provide temporary vascular occlusion while maintaining distal perfusion along with vascular access. The temporary' vascular occlusion device may include a multiple layer scaffold covering having proximal and distal attachment zones separated by an unattached scaffold covering zone where the scaffold covering is adjacent to but not attached directly to the scaffold frame. Devices for a vascular procedure may access the vasculature using a guide catheter in the shaft of the occlusion device. The occlusion device may then be used to provide protection from contrast media, used during the vascular procedure conducted using the access provided by the occlusion device.

Inventors:
DEBEER NICHOLAS (US)
LEONG DANIEL (US)
Application Number:
PCT/US2022/075777
Publication Date:
March 09, 2023
Filing Date:
August 31, 2022
Export Citation:
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Assignee:
RENALPRO MEDICAL INC (US)
International Classes:
A61B17/221; A61F2/82; A61M25/01; A61M25/10; A61M39/10
Foreign References:
US20140142598A12014-05-22
US20200078570A12020-03-12
US20200100792A12020-04-02
Attorney, Agent or Firm:
PATANKAR, Madhavi et al. (US)
Download PDF:
Claims:
CLAIMS What is claimed is: 1. A vascular occlusion device, comprising: a scaffold catheter having a scaffold structure coupled to a scaffold catheter shaft; a scaffold sheathing catheter having a scaffold sheathing catheter shaft with a proximal end and a distal end with a full round distal end section at the distal end, the full round distal end section having a distal end, a lumen and a proximal end; a shaft sleeve having a proximal end and a distal end and a lumen, wherein the scaffold catheter shaft is nested within the scaffold sheathing shaft within the shaft sleeve lumen. 2. The vascular occlusion device of claim 1 the scaffold structure further comprising one or more layer scaffold covering over at least a portion of the scaffold structure, the one or more layer scaffold covering having a distal scaffold attachment zone where a portion of the scaffold covering is attached to a distal portion of the scaffold, a proximal scaffold attachment zone where a portion of the scaffold covering is attached to a proximal portion of the scaffold and an unattached zone between the distal attachment zone and the proximal attachment zone wherein the scaffold covering is unattached to an adjacent portion of the scaffold. 3. The vascular device of claim 1 further comprising a handle having a first part and a second part wherein the first part is coupled to a proximal portion of the scaffold sheathing catheter shaft and the second part is coupled to a proximal portion of the scaffold catheter shaft and wherein a proximal portion of the shaft sleeve is coupled to the handle so as to allow access to the shaft sleeve lumen by the scaffold sheathing catheter shaft and the scaffold catheter shaft. 4. The vascular device of claim 3 wherein movement of the handle first part relative to the handle second part moves the scaffold relative to the full round distal end section. 5. The vascular device of claim 3 wherein movement of the handle first part relative to the handle second part transitions the scaffold from a stowed configuration within the full round distal end section lumen and a deployed configuration where the scaffold is outside of the full round section distal end section lumen.

6. The vascular device of any of the above claims wherein the cross section shape of the scaffold catheter shaft and the sheathing catheter shaft has an outer surface with a curvature conforming to a curvature of an interior wall of an introducer. 7. The vascular device of any of the above claims wherein the cross section shapes of the scaffold catheter shaft and the sheathing catheter shaft have a complementary shape so that in use the shafts are nested. 8. The vascular device of any of the above claims wherein the cross section shapes of the scaffold catheter shaft, the sheathing catheter shaft and the shaft sleeve are complementary shapes so that in use the shafts are nested within the shaft sleeve lumen. 9. The vascular device of any of the above claims wherein the cross section shapes of the scaffold catheter shaft, the sheathing catheter shaft and the shaft sleeve are complementary shapes to the interior lumen of an introducer so as to provide an interior lumen of an introducer comprising the interior wall of the introducer and an exterior wall of the shaft sleeve or the scaffold catheter. 10. The vascular device of any of the above claims further comprising an introducer having an interior lumen and a proximal end and a distal end wherein in use with the shaft sleeve present within the introducer lumen and extending beyond the distal end there remains within the introducer lumen sufficient space to pass an intravascular device along the introducer lumen. 11. The vascular device of claim 10 wherein the intravascular device has a size of about 5Fr. 12. The vascular device of claim 10 wherein the intravascular device has a size of from about 3 Fr to 6Fr. 13. The vascular device of any of the above claims wherein in use the introducer lumen is utilized to allow simultaneously access for the shaft sleeve containing the scaffold catheter shaft and the scaffold sheathing catheter shaft alongside a guide catheter adapted for passing an intravascular device that is one of a diagnostic instrument, or an instrument selected from the group consisting of: an angiography catheter, an intravascular ultrasound testing instrument, or an intravascular optical coherence tomography instrument, and the therapeutic instrument is preferably a balloon catheter, a drug-eluting balloon catheter, a bare metal stent, a drug-eluting stent, a drug-eluting biodegradable stent, a rotablator, a thrombus suction catheter, a drug administration catheter, a guiding catheter, a support catheter, or a device or a prosthesis delivered as part of a intravascular procedure or system. 14. The vascular device of any of claims 1-13 wherein the scaffold covering extends completely circumferentially about the scaffold structure from the distal attachment zone to the proximal attachment zone. 15. The scaffold in any of claims 1-14 wherein the scaffold structure having a distal end, a scaffold transition zone and a proximal end having one or a plurality of legs wherein the one leg or each leg of the plurality legs is coupled to a distal portion of the inner shaft, wherein the scaffold structure moves from a stowed configuration when the outer shaft is extended over the scaffold structure and a deployed configuration when the outer shaft is retracted from covering the scaffold structure. 16. A vascular device, comprising: an introducer having an interior lumen with an interior wall; a shaft sleeve having an inner wall and an outer wall and a lumen having a cross section shape defined by the outer wall and the inner wall, wherein in the outer wall has a shape that is conformal to a curvature of a portion of the interior wall, wherein when the shaft sleeve is within the introducer, the modified introducer interior lumen is defined by the interior wall and the portion of the shaft sleeve outer wall in communication with the interior lumen; a scaffold catheter shaft and a sheathing catheter shaft within the shaft sleeve lumen; and a guide catheter adapted for passing an intravascular device that is one of a diagnostic instrument, or an instrument selected from the group consisting of: an angiography catheter, an intravascular ultrasound testing instrument, or an intravascular optical coherence tomography instrument, and the therapeutic instrument is preferably a balloon catheter, a drug-eluting balloon catheter, a bare metal stent, a drug-eluting stent, a drug-eluting biodegradable stent, a rotablator, a thrombus suction catheter, a drug administration catheter, a guiding catheter, a support catheter, or a device or a prosthesis delivered as part of a intravascular procedure or system, wherein in use the guide catheter or intravascular device is within the introducer alongside the shaft sleeve for simultaneous use of the intravascular device and an occlusion with device coupled to the scaffold catheter.

17. The device of claim 16 further comprising a scaffold having a scaffold covering that extends partially circumferentially about the scaffold structure from the distal attachment zone to the proximal attachment zone with an uncovered scaffold structure. 18. The device of claim 17 wherein the scaffold covering extends partially circumferentially about 270 degrees of the scaffold structure from the distal attachment zone to the proximal attachment zone. 19. The device of claim 17 wherein a first scaffold covering extends partially circumferentially about 45 degrees of the scaffold structure from the distal attachment zone to the proximal attachment zone and a second scaffold covering extends partially circumferentially about 45 degrees of the scaffold structure from the distal attachment zone to the proximal attachment zone, wherein the first scaffold covering and the second scaffold covering are on opposite sides of the longitudinal axis of the scaffold structure. 20. The device of claims 17, 18 or 19 wherein scaffold covering is formed from a single or multiple layers. 21. The device of claim 20 wherein the layers of the multiple layer scaffold covering are selected from ePFTE, PTFE, FEP, polyurethane or silicone. 22. The vascular occlusion device of any of claims 16-21 wherein the scaffold covering or the more than one layers of a multiple layer scaffold covering is applied to a scaffold structure external surface, to a scaffold structure internal surface, to encapsulate the distal scaffold attachment zone and the proximal scaffold attachment zone, as a series of spray coats, dip coats or electron spin coatings to the scaffold structure. 23. The vascular occlusion device of claim 22 wherein the multiple layer scaffold covering has a thickness of 5 – 100 microns or wherein the multiple layer scaffold covering has a thickness of about 0.001 inches in an unattached zone and a thickness of about 0.002 inches in an attached zone. 24. A method of providing selective occlusion with distal perfusion using a vascular occlusion device, comprising: positioning an introducer to access an aortic arch of a patient; advancing the scaffold vascular occlusion device in a stowed condition within a scaffold sheathing catheter along a blood vessel to a position adjacent to one or more peripheral blood vessels in the portion of the vasculature of the patient selected for occlusion while the vascular occlusion device is tethered to a handle outside of the patient; transitioning the vascular occlusion device from the stowed condition to a deployed condition using the handle to withdraw a full round distal end section of the sheathing catheter wherein the deployed vascular occlusion device at least partially occludes blood flow into the one or more peripheral blood vessels selected for occlusion; deflecting a portion of an unattached zone of the covered scaffold in response to the blood flow through the lumen of the covered scaffold into an adjacent opening of the one or more peripheral blood vessels in the portion of the vasculature of the patient selected for occlusion; accessing the patient vasculature with an intravascular device using the introducer; performing an intravascular procedure using the intravascular device while the scaffold occlusion device is present within the vasculature; removing the intravascular device from the patient vasculature via the introducer; transitioning the vascular occlusion device from the deployed condition to the stowed condition using the handle to advance the full round distal section over the scaffold; and withdrawing the vascular occlusion device in the stowed condition from the patient via the introducer. 25. The method of claim 24 wherein the position of the vascular occlusion device engages with a superior aspect of the vasculature to direct blood flow into and along a lumen defined by a scaffold structure of the vascular occlusion device 26. The method of claim 24 or claim 25 wherein the one or more peripheral blood vessels in the portion of the vasculature of the patient selected for occlusion is selected from the group consisting of a hepatic artery, a gastric artery, a celiac trunk, a splenic artery, an adrenal artery, a renal artery, a superior mesenteric artery, an ileocolic artery, a gonadal artery and an inferior mesenteric artery. 27. The method of claim 24 or claim 25 the covered scaffold unattached zone further comprising a position of a portion of the unattached zone to deflect into a portion of at least one of a hepatic artery, a gastric artery, a celiac trunk, a splenic artery, an adrenal artery, a renal artery, a superior mesenteric artery, an ileocolic artery, a gonadal artery and an inferior mesenteric artery when the vascular occlusion device is positioned within a portion of the aorta. 28. A method of temporarily occluding a blood vessel, comprising: a. advancing a vascular occlusion device in a stowed condition along a blood vessel to a position adjacent to one or more peripheral blood vessels selected for temporary occlusion; b. transitioning the vascular occlusion device from the stowed condition to a deployed condition by advancing the vascular occlusion device from within a full round distal section of a scaffold sheathing catheter wherein thereafter the vascular occlusion at least partially occludes blood flow into the one or more peripheral blood vessels selected for temporary occlusion while directing the blood flow through and along a lumen of a covered scaffold of the vascular occlusion device; and c. performing a vascular intervention within the patient vasculature while the vascular occlusion device is present within the blood vessel, wherein using an imaging contrast agent during the vascular intervention initiates a period of temporary occlusion; d. transitioning the vascular occlusion device out of the deployed condition to restore blood flow into the one or more peripheral blood vessels selected for temporary occlusion when a period of temporary occlusion is elapsed. 29. The method of claim 28 wherein directing the blood flow through and along the lumen of the vascular occlusion device maintains blood flow to components and vessels distal to the vascular occlusion device while at least partially occluding the blood flow to the one or more peripheral blood vessels. 30. The method of claim 28 or claim 29 wherein the one or more peripheral blood vessels are the vasculature of a liver, a kidney, a stomach, a spleen, an intestine, a stomach, an esophagus, or a gonad. 31. The method of claim 28 or claim 29 wherein the blood vessel is an aorta and the peripheral blood vessels are one or more or a combination of: a hepatic artery, a gastric artery, a celiac trunk, a splenic artery, an adrenal artery, a renal artery, a superior mesenteric artery, an ileocolic artery, a gonadal artery and an inferior mesenteric artery.

Description:
CONTROLLABLE OCCLUSION WITH PERFUSION DEVICE FOR USE DURING RADIAL ACCESS VASCULAR INTERVENTION PROCEDURES CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Application No.63/239,940, filed September 1, 2021 and U.S. Provisional Application No.63/241,925, filed September 8, 2021, the entire disclosures of which are incorporated by reference herein. INCORPORATION BY REFERENCE [0002] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. FIELD [0003] This application relates to various methods and devices for at least partially occluding peripheral blood flow from a blood vessel while maintaining perfusion to blood vessels and structures distal to the occlusion site. Additionally, the occlusion devices may also enable a single vascular access point for simultaneous use of a therapeutic device in conjunction with use of the occlusion device. Still further, embodiments of the present invention relate generally to medical interventions conducted through vessels of the vasculature such as the major arteries, veins and more particularly to access and deployment configurations for conducting vascular interventions using the right or left renal artery. A single introducer sheath is used to provide access to a scaffold based occlusion with perfusion device modified to allow simultaneous access to a vascular intervention device. The occlusion with perfusion device is used to provide protection or reduction of harm to exposure to imaging contrast agents used during the above mentioned procedures. BACKGROUND [0004] Contrast Induced Acute kidney injury (CI-AKI), also called acute renal failure (ARF), is a rapid loss of kidney function. Its causes are numerous and include low blood volume from any cause, exposure to substances harmful to the kidney, and obstruction of the urinary tract. CI- AKI is diagnosed on the basis of characteristic laboratory findings, such as elevated blood creatinine, or inability of the kidneys to produce sufficient amounts of urine. [0005] Contrast Induced Acute Kidney Injury is diagnosed on the basis of clinical history and laboratory data. A diagnosis is made when there is rapid reduction in kidney function, as measured by serum creatinine, or based on a rapid reduction in urine output, termed oliguria. [0006] For example, the use of intravascular iodinated contrast agents may cause acute kidney injury. In patients receiving intravascular iodine-containing contrast media for angiography, contrast-induced AKI (CI-AKI) is a common problem and is associated with excessive hospitalization cost, morbidity, and mortality. Clinical procedures involving intravascular iodine-containing contrast media injection include for example, percutaneous coronary intervention (PCI), peripheral vascular angiography and intervention, neurological angiography and intervention. Solutions have been suggested for occluding at least partially the blood flow into the renal arteries during procedures where a patient is exposed to intravascular contrast. [0007] Gaining access to the heart and other parts of the cardiovascular anatomy is a continued challenge in cardiovascular medicine. For example, conventional open-surgical procedures for accomplishing tasks such as valve replacement generally involve a thoracotomy and/or creation of one or more access ports across the wall of the heart itself, which is relatively highly invasive and therefore undesirable. Recent progress has been made in the area of catheter- based percutaneous intervention, wherein instrumentation, such as catheters, guidewires, and prostheses, are brought to the heart, brain, or other tissue structures associated with the cardiovascular system through the vessels connected to such structures. These vascular pathways may be quite tortuous and geometrically small, and thus one of the challenges with percutaneous procedures lies in gaining access, conducting the desired interventional and/or diagnostic procedures, and removing the pertinent instrumentation, without damaging the vasculature or associated anatomy. [0008] Conventionally with percutaneous procedures, introducer and dilator sets have been utilized to provide a usable access conduit through an arteriotomy or other surgical access to the vasculature. For procedures on large, relatively straight, and relatively undiseased vessels, such configurations may be adequate, but frequently cardiovascular diagnostic and/or interventional procedures are conducted on diseased cardiovascular systems and in tortuous anatomy. There is a need for better access tools and procedures, which may be utilized to establish vascular access in a relatively efficient geometric package (i.e., in a collapsed state), be expanded in situ as necessary to pass instrumentation, prostheses, or other structures (for example, the un-expanded delivery size of a commercially available aortic valve prosthesis may be up to 18 French or more such as other valves having an un-expanded delivery size of a between 18 and 24 French, depending upon which size is utilized) and to be re-collapsed before or during withdrawal so that the associated anatomy is not undesirably loaded or damaged during such withdrawal. Moreover, the increased availability of such devices and the accompanying use of imaging contrast agents to assist in their proper implantation is leading to an increased risk of patient over exposure to contrast. As such, there remains a need for improvements in introducer sheaths as well as in protection for damage to collateral structures such as the kidneys from exposure to imaging contrast or other agents. [0009] There is also a continuing need for reducing complexity in coordination of device use in vascular procedures. Additionally, it is clinically desirous to reduce where possible the number of access points into the patient’s vasculature. [0010] While some solutions have been proposed for vascular occlusion and access, the need for improved methods and especially combination devices remain. SUMMARY OF THE DISCLOSURE [0011] In general, in one embodiment, a vascular occlusion device includes a scaffold catheter having a scaffold structure coupled to a scaffold catheter shaft, a scaffold sheathing catheter having a scaffold sheathing catheter shaft with a proximal end and a distal end with a full round distal end section at the distal end, the full round distal end section having a distal end, a lumen and a proximal end and a shaft sleeve having a proximal end and a distal end and a lumen, wherein the scaffold catheter shaft is nested within the scaffold sheathing shaft within the shaft sleeve lumen. [0012] This and other embodiments can include one or more of the following features. The vascular occlusion device can further include one or more layer scaffold covering over at least a portion of the scaffold structure, the one or more layer scaffold covering can have a distal scaffold attachment zone where a portion of the scaffold covering is attached to a distal portion of the scaffold, a proximal scaffold attachment zone where a portion of the scaffold covering is attached to a proximal portion of the scaffold and an unattached zone between the distal attachment zone and the proximal attachment zone wherein the scaffold covering is unattached to an adjacent portion of the scaffold. The vascular device can further include a handle having a first part and a second part wherein the first part is coupled to a proximal portion of the scaffold sheathing catheter shaft and the second part is coupled to a proximal portion of the scaffold catheter shaft and wherein a proximal portion of the shaft sleeve is coupled to the handle so as to allow access to the shaft sleeve lumen by the scaffold sheathing catheter shaft and the scaffold catheter shaft. Movement of the handle first part relative to the handle second part can move the scaffold relative to the full round distal end section. Movement of the handle first part relative to the handle second part can transition the scaffold from a stowed configuration within the full round distal end section lumen and a deployed configuration where the scaffold is outside of the full round section distal end section lumen. The cross section shape of the scaffold catheter shaft and the sheathing catheter shaft can have an outer surface with a curvature conforming to a curvature of an interior wall of an introducer. The cross section shapes of the scaffold catheter shaft and the sheathing catheter shaft can have a complementary shape so that in use the shafts are nested. The cross section shapes of the scaffold catheter shaft, the sheathing catheter shaft and the shaft sleeve can be complementary shapes so that in use the shafts are nested within the shaft sleeve lumen. The cross section shapes of the scaffold catheter shaft, the sheathing catheter shaft and the shaft sleeve can be complementary shapes to the interior lumen of an introducer so as to provide an interior lumen of an introducer comprising the interior wall of the introducer and an exterior wall of the shaft sleeve or the scaffold catheter. The vascular device can further include an introducer having an interior lumen and a proximal end and a distal end wherein in use with the shaft sleeve present within the introducer lumen and extending beyond the distal end there remains within the introducer lumen sufficient space to pass an intravascular device along the introducer lumen. The intravascular device can have a size of about 5Fr. The intravascular device can have a size of from about 3 Fr to 6Fr. In use, the introducer lumen can be utilized to allow simultaneously access for the shaft sleeve containing the scaffold catheter shaft and the scaffold sheathing catheter shaft alongside a guide catheter adapted for passing an intravascular device that is one of a diagnostic instrument, or an instrument selected from the group consisting of: an angiography catheter, an intravascular ultrasound testing instrument, or an intravascular optical coherence tomography instrument, and the therapeutic instrument is preferably a balloon catheter, a drug-eluting balloon catheter, a bare metal stent, a drug-eluting stent, a drug-eluting biodegradable stent, a rotablator, a thrombus suction catheter, a drug administration catheter, a guiding catheter, a support catheter, or a device or a prosthesis delivered as part of a intravascular procedure or system. The scaffold covering can extend completely circumferentially about the scaffold structure from the distal attachment zone to the proximal attachment zone. The scaffold structure can have a distal end, a scaffold transition zone and a proximal end having one or a plurality of legs. The one leg or each leg of the plurality legs can be coupled to a distal portion of the inner shaft. The scaffold structure can move from a stowed configuration when the outer shaft is extended over the scaffold structure and a deployed configuration when the outer shaft is retracted from covering the scaffold structure. [0013] In general, in one embodiment, a vascular device includes an introducer having an interior lumen with an interior wall, a shaft sleeve having an inner wall and an outer wall and a lumen having a cross section shape defined by the outer wall and the inner wall, wherein in the outer wall has a shape that is conformal to a curvature of a portion of the interior wall, wherein when the shaft sleeve is within the introducer, the modified introducer interior lumen is defined by the interior wall and the portion of the shaft sleeve outer wall in communication with the interior lumen, a scaffold catheter shaft and a sheathing catheter shaft within the shaft sleeve lumen, and a guide catheter adapted for passing an intravascular device that is one of a diagnostic instrument, or an instrument selected from the group consisting of: an angiography catheter, an intravascular ultrasound testing instrument, or an intravascular optical coherence tomography instrument, and the therapeutic instrument is preferably a balloon catheter, a drug- eluting balloon catheter, a bare metal stent, a drug-eluting stent, a drug-eluting biodegradable stent, a rotablator, a thrombus suction catheter, a drug administration catheter, a guiding catheter, a support catheter, or a device or a prosthesis delivered as part of a intravascular procedure or system, wherein in use the guide catheter or intravascular device is within the introducer alongside the shaft sleeve for simultaneous use of the intravascular device and an occlusion with device coupled to the scaffold catheter. [0014] This and other embodiments can include one or more of the following features. The device can further include a scaffold having a scaffold covering that extends partially circumferentially about the scaffold structure from the distal attachment zone to the proximal attachment zone with an uncovered scaffold structure. The scaffold covering can extend partially circumferentially about 270 degrees of the scaffold structure from the distal attachment zone to the proximal attachment zone. A first scaffold covering can extend partially circumferentially about 45 degrees of the scaffold structure from the distal attachment zone to the proximal attachment zone and a second scaffold covering extends partially circumferentially about 45 degrees of the scaffold structure from the distal attachment zone to the proximal attachment zone, wherein the first scaffold covering and the second scaffold covering are on opposite sides of the longitudinal axis of the scaffold structure. The scaffold covering can be formed from a single or multiple layers. The layers of the multiple layer scaffold covering can be selected from ePFTE, PTFE, FEP, polyurethane or silicone. The scaffold covering or the more than one layers of a multiple layer scaffold covering can be applied to a scaffold structure external surface, to a scaffold structure internal surface, to encapsulate the distal scaffold attachment zone and the proximal scaffold attachment zone, as a series of spray coats, dip coats or electron spin coatings to the scaffold structure. The multiple layer scaffold covering can have a thickness of 5 – 100 microns or wherein the multiple layer scaffold covering has a thickness of about 0.001 inches in an unattached zone and a thickness of about 0.002 inches in an attached zone. [0015] In general, in one embodiment, a method of providing selective occlusion with distal perfusion using a vascular occlusion device includes: (1) positioning an introducer to access an aortic arch of a patient; (2) advancing the scaffold vascular occlusion device in a stowed condition within a scaffold sheathing catheter along a blood vessel to a position adjacent to one or more peripheral blood vessels in the portion of the vasculature of the patient selected for occlusion while the vascular occlusion device is tethered to a handle outside of the patient; (3) transitioning the vascular occlusion device from the stowed condition to a deployed condition using the handle to withdraw a full round distal end section of the sheathing catheter wherein the deployed vascular occlusion device at least partially occludes blood flow into the one or more peripheral blood vessels selected for occlusion; (4) deflecting a portion of an unattached zone of the covered scaffold in response to the blood flow through the lumen of the covered scaffold into an adjacent opening of the one or more peripheral blood vessels in the portion of the vasculature of the patient selected for occlusion; (5) accessing the patient vasculature with an intravascular device using the introducer; (6) performing an intravascular procedure using the intravascular device while the scaffold occlusion device is present within the vasculature; (7) removing the intravascular device from the patient vasculature via the introducer; (8) transitioning the vascular occlusion device from the deployed condition to the stowed condition using the handle to advance the full round distal section over the scaffold; and (9) withdrawing the vascular occlusion device in the stowed condition from the patient via the introducer. [0016] This and other embodiments can include one or more of the following features. The position of the vascular occlusion device can engage with a superior aspect of the vasculature to direct blood flow into and along a lumen defined by a scaffold structure of the vascular occlusion device. The one or more peripheral blood vessels in the portion of the vasculature of the patient selected for occlusion can be selected from the group consisting of a hepatic artery, a gastric artery, a celiac trunk, a splenic artery, an adrenal artery, a renal artery, a superior mesenteric artery, an ileocolic artery, a gonadal artery and an inferior mesenteric artery. The covered scaffold unattached zone can further include a position of a portion of the unattached zone to deflect into a portion of at least one of a hepatic artery, a gastric artery, a celiac trunk, a splenic artery, an adrenal artery, a renal artery, a superior mesenteric artery, an ileocolic artery, a gonadal artery and an inferior mesenteric artery when the vascular occlusion device is positioned within a portion of the aorta. [0017] In general, in one embodiment, a method of temporarily occluding a blood vessel includes: (1) advancing a vascular occlusion device in a stowed condition along a blood vessel to a position adjacent to one or more peripheral blood vessels selected for temporary occlusion; (2) transitioning the vascular occlusion device from the stowed condition to a deployed condition by advancing the vascular occlusion device from within a full round distal section of a scaffold sheathing catheter wherein thereafter the vascular occlusion at least partially occludes blood flow into the one or more peripheral blood vessels selected for temporary occlusion while directing the blood flow through and along a lumen of a covered scaffold of the vascular occlusion device; (3) performing a vascular intervention with in the patient vasculature while the vascular occlusion device is present within the blood vessel, wherein using a imaging contrast agent during the vascular intervention initiates a period of temporary occlusion; and (4) transitioning the vascular occlusion device out of the deployed condition to restore blood flow into the one or more peripheral blood vessels selected for temporary occlusion when a period of temporary occlusion is elapsed. [0018] This and other embodiments can include one or more of the following features. Directing the blood flow through and along the lumen of the vascular occlusion device can maintain blood flow to components and vessels distal to the vascular occlusion device while at least partially occluding the blood flow to the one or more peripheral blood vessels. The one or more peripheral blood vessels can be the vasculature of a liver, a kidney, a stomach, a spleen, an intestine, a stomach, an esophagus, or a gonad. The blood vessel can be an aorta and the peripheral blood vessels are one or more or a combination of: a hepatic artery, a gastric artery, a celiac trunk, a splenic artery, an adrenal artery, a renal artery, a superior mesenteric artery, an ileocolic artery, a gonadal artery and an inferior mesenteric artery. BRIEF DESCRIPTION OF THE DRAWINGS [0019] A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are used, and the accompanying drawings of which: [0020] FIG.1 illustrates an exploded view of an exemplary embodiment of an occlusion with perfusion device or scaffold with a scaffold sheathing catheter and shaft sleeve. Diagram of an exemplary invention device comprises an occlusion catheter having a covered scaffold positioned at the infra-renal aorta position near orifices of bilateral renal arteries for treating acute kidney injury. [0021] FIG.2 illustrates the components of the scaffold based occlusion with perfusion device of FIG.1 arranged with the scaffold catheter shaft alongside the sheathing catheter shaft with the scaffold structure proximal to the full round distal end of the scaffold sheathing catheter. [0022] FIG.3 illustrates the components of FIGs.1 and 2 with the scaffold based occlusion with perfusion device of FIG.1 arranged with the scaffold catheter shaft alongside the sheathing catheter shaft within the shaft sleeve lumen and the scaffold structure within the lumen of the full round distal end of the scaffold sheathing catheter. A guidewire is shown alongside the shaft sleeve and within the scaffold lumen and exiting the full round distal end lumen. [0023] FIGs.3A-3D represent the cross section views indicated on FIG.3. [0024] FIG.3E is a cross section view of an alternative shaft sleeve having an inner wall that corresponds to the curvature of the scaffold catheter shaft. This illustration is an example of nesting the cross section profiles of the shaft sleeve, the scaffold catheter and the scaffold sheathing catheter. [0025] FIG.3D1 is a cross section view of a shaft sleeve as in FIG.3D within an introducer lumen representing the remaining portion of the introducer lumen with the shaft sleeve present. [0026] FIG.3E1 is a cross section view of a shaft sleeve as in FIG.3E within an introducer lumen representing the remaining portion of the introducer lumen with the shaft sleeve present [0027] FIG.4 is a profile view of the components of the scaffold occlusion with perfusion device of FIG.1 in relationship to an introducer. [0028] FIG.5 is an isometric view of the components of the scaffold occlusion with perfusion device of FIG.4 in relationship to the distal end of the introducer as well as exit of the shafts from the distal most end of the shaft sleeve. The break portion indicates that the position of the occlusion device may be at the renal ostia while the distal end of the introducer may be positioned to provide access to an aortic arch. [0029] FIG.6 shows the arrangement of the components in FIG.5 with a guidewire positioned beyond the distal end of the introducer and separated from the shaft sleeve. [0030] FIG.7A shows the arrangement of the components in FIG.6 with an intravascular device advanced along the guidewire. [0031] FIG.7B is a cross section view along section A-A of FIG.7A showing how the interior of the introducer is apportioned between the interventional device and the shaft sleeve and included shafts. The relative sizes of the components are exaggerated in this view. In alternative aspects the intervascular device utilizes a greater portion of the introducer lumen interior than those occupied by the shaft sleeve. Importantly, in use, the shaft sleeve remains against the interior wall of the introducer lumen such that the lumen accessed by the interventional device is formed by the introducer interior wall not covered by the shaft sleeve and the inner wall of the shaft sleeve (e.g., the wall of the shaft sleeve adjacent to or contacting the interventional device. In another aspect, the shaft sleeve outer wall in conformal to or complementary in shape to the outer wall of the intravascular device. [0032] FIG.8 shows at representative arteries access via a radial artery access procedure. [0033] FIG.9 shows a guidewire accessing the patient vasculature via the radial artery. [0034] FIG.10A is an initial insertion of an introducer and dilator into the radial artery over the guide wire in FIG.9. [0035] FIG.10B is an enlarged view of the introducer and dilator into the radial artery over the guide wire in FIG.10A. [0036] FIG.11A is an overall view of the introducer and dilator of FIG.10B accessing the aortic arch of the patient. FIG.11B is an enlarged view of the introducer and dilator positioned as in FIG.11A. [0037] FIG.12 is the withdrawal of the dilator leaving the introducer distal end accessing the aortic arch. [0038] FIG.13 is the withdrawal of the dilator from the access site. [0039] FIG.14 is the advancement of the scaffold occlusion with perfusion device of FIG.1 along the guidewire towards the access site. [0040] FIG.15A is the advancement of the scaffold occlusion with perfusion device of FIG. 14 beyond the distal end of the introducer and accessing the aortic arch. [0041] FIG.15B is an enlarged cross section view of FIG.15A showing the components within the aortic arch. [0042] FIG.16 is the continuing advancement of the components in FIG.15B along the guidewire and the aorta. [0043] FIG.17A is the continuing advancement of the components in FIG.16 along the guidewire and the aorta into position adjacent to the renal artery ostia. In this position the full round section of the scaffold sheathing catheter containing the stowed scaffold is alongside the ostia. [0044] FIG.17B is an enlarged view of the arrangement of the components in FIG.17. [0045] FIG.18A is an overall view of the arrangement of the components in FIG.17B as the full round distal section of the scaffold sheathing catheter is withdrawn proximally. The distal most portion of the scaffold is shown beginning the transition to the deployed configuration to at least partially occlude the renal ostia. [0046] FIG.18B is an enlarged view of the arrangement of the components in FIG.18A as the full round distal section of the scaffold sheathing catheter continues to be withdrawn proximally. An additional portion of the distal most portion of the scaffold is transitioning into the deployed configuration to at least partially occlude the renal ostia. [0047] FIG.18C is an overall view of the arrangement of the components in FIG.18B as the full round distal section of the scaffold sheathing catheter continues to be withdrawn proximally. An additional portion of the distal most portion of the scaffold is transitioning into the deployed configuration to at least partially occlude the renal ostia. [0048] FIG.18D is an enlarged view of the arrangement of the components in FIG.18C as the full round distal section of the scaffold sheathing catheter has been withdrawn proximally beyond the coupling. In this view the scaffold is fully transitioned into the deployed configuration to at least partially occlude the renal ostia. [0049] FIG.18E is an enlarged view of the arrangement of the scaffold and the scaffold sheathing catheter while the scaffold is provided occlusion with distal perfusion. In this view the scaffold or scaffold covering is distended into the renal ostia. [0050] FIG.18F is an enlarged view of the arrangement of the scaffold and the scaffold sheathing catheter while the scaffold is provided occlusion with distal perfusion. In this view the scaffold or scaffold covering is not distended into the renal ostia. [0051] FIG.18G is an overall view of the arrangement of the scaffold and the scaffold sheathing catheter while the scaffold is provided occlusion with distal perfusion as in FIG.18E showing the withdrawal of the guidewire to prepare for the introduction of an interventional device in conjunction with the use of the scaffold occlusion device. [0052] FIG.18H represents the continued withdrawal of the guidewire. [0053] FIG.18I is the repositioning of the guidewire while adjacent to the shaft sheath and within the same introducer. [0054] FIG.18J is the repositioned guidewire for guiding an intervascular device to be used in a procedure accessed using the same introducer and simultaneously with the scaffold occlusion device. [0055] FIG.19A is placement of the intervascular device onto the guidewire positioned in FIG.18J. The intervascular device will be used in a procedure accessed using the same introducer and simultaneously with the scaffold occlusion device. [0056] FIG.19B is a partial cross section and exploded view of the arrangement of the scaffold components above alongside the intervascular device as it is advanced along the guidewire positioned as in FIG.18J. [0057] FIG.19C is an overall view of the components in FIG.19A accessing the aortic arch. [0058] FIG.19D is the enlarged view of the components in FIG.19C accessing the aortic arch with the intervascular device exiting the same introducer used for the scaffold occlusion device while the scaffold device is present and adjacent to the renal arteries. [0059] FIGs.20A and 20B are perspective views of an alternative scaffold structure using deflectable rings on the scaffold catheter. FIG.20A illustrates the rings in a deployed configuration. FIG.20B represents the rings in a stowed condition as would be within the full round distal section (See FIG.3) [0060] FIGs.20C and 20D illustrate the rings of FIG.20A and 20B with a scaffold covering in place that extends between the rings. [0061] FIGs.21A-21C represent the delivery of an embodiment of the rings in FIG.20C within the aorta to occlude the renal ostia. [0062] FIG.22A is an embodiment of the rings in FIG.20C where the scaffold covering only extends about 270 degrees around the rings. This embodiment is deployed in the aorta in the view of FIG.22C and in the cross section view of FIG.22E. [0063] FIG.22B is an embodiment of the rings in FIG.20C where the scaffold covering only extends about two partial segments around the rings. This embodiment is deployed in the aorta in the view of FIG.22D and in the cross section view of FIG.22F. [0064] FIGs.23A and 23B are perspective views of an alternative scaffold structure using deflectable rings on the scaffold catheter of different sizes. FIG.23A illustrates the rings in a deployed configuration with a larger diameter proximal ring than the distal ring. FIG.23B represents the rings in a stowed condition as would be within the full round distal section (See FIG.3) [0065] FIGs.23C and 23D illustrate the rings of FIG.23A and 23B with a scaffold covering in place that extends between the rings. [0066] FIG.23E represents the delivery of an embodiment of the rings in FIG.23C within the aorta to occlude the renal ostia. [0067] FIG.24A is a scaffold structure that extends along the scaffold catheter responsive to the movement of the full round distal end. FIG.24B is the scaffold structure of FIG.24A when deployed. [0068] FIG.24C is the scaffold device of FIG.24A adjacent to the renal ostia. [0069] FIG.24D is the scaffold structure of FIG.24B in position to occlude the renal ostia once the full round section has been withdrawn. [0070] FIG.25A is a scaffold structure that extends along the scaffold catheter responsive to the movement of the full round distal end. A coil structure withing the covering is extended while stowed. FIG.25B is the scaffold structure of FIG.25A when deployed by allowing the coil structure to move when unconstrained by the full round section. [0071] FIG.25C is the coil scaffold structure of FIG.25B in position to occlude the renal ostia constrained by the full round section. [0072] FIG.25D is the scaffold structure of FIG.25C in position to occlude the renal ostia in a deployed configuration since the full round section has been withdrawn. [0073] FIG.26 is a flow chart of an exemplary method of providing occlusion with perfusion using an embodiment of a vascular occlusion device herein according to the method 2600. [0074] FIG.27 is a flow chart of an exemplary method of providing occlusion with perfusion using an embodiment of a vascular occlusion device according to the method 2700. DETAILED DESCRIPTION [0075] Current treatments/managements for acute kidney injury (AKI), especially contrast- induced acute kidney injury are mainly supportive. They include for example, (1) evaluating and stratifying patients with Mehran risk score before performing percutaneous coronary intervention (PCI), (2) avoiding high-osmolar contrast media by using low-osmolar or iso-osmolar contrast media, (3) reducing the amount of contrast media during PCI, and (4) applying intravenously isotonic sodium chloride solution or sodium bicarbonate solution hours before and after PCI, (5) avoiding use of nephrotoxic drugs (such as nonsteroidal anti-inflammatory drugs, aminoglycosides antibiotics, etc.) See Stevens 1999, Schweiger 2007, Solomon 2010. However, none of them were proven with consistent effect in preventing CI-AKI. [0076] Provided herein are devices and systems that specifically focus on solving the two main pathophysiological culprits of CI-AKI, which are renal outer medulla ischemia and/or prolonged transit of contrast media inside the kidneys. The embodiments described herein may be used simultaneously with other vascular interventional devices prior to the use of imaging contrast or to remain in a deployed condition throughout the vascular intervention procedure. [0077] In some embodiments, there are provided a device for treating acute kidney injury (e.g., CI-AKI) comprising a scaffold based occlusion with perfusion structure adapted and configured to occlude partially or completely the ostia on both sides of the aorta for the renal arteries while allowing blood flow going through the lumen of the scaffold structure and into the distal portions of the aorta beyond the device and on to distal vascular structures. In some embodiments, a position indication means is provided on the scaffold structure or associated sheathing structure which may be a radio-opaque marker, or the like. [0078] Radio opaque markers are vital prerequisites on an increasing number of endovascular medical devices and are appropriately provided on the various embodiments to allow positioning of the temporary occlusion device. The value of radio opaque markers is clearly seen in visibility improvement during deployment of the device. Markers allow for improved tracking and positioning of an implantable device during a procedure using fluoroscopy or radiography. [0079] While some embodiments have been described for use in mitigating CI-AKI, alternative non-balloon based occlusion or partial occlusion devices are also provided. Moreover, such alternative partial or complete peripheral occlusion devices simultaneously provide for distal perfusion blood flow into vessels and structures beyond the occlusion device. [0080] As a result, various occlusion device embodiments may be provided that are adapted and configured to provide temporary occlusion of the peripheral vasculature of the suprarenal and infrarenal abdominal aortic area while maintaining distal perfusion. [0081] Exemplary clinical applications include but are not limited to: [0082] Total or nearly total vascular occlusion of blood flow during the surgical treatment of renal tumors through Retroperitoneoscopic Radical Nephrectomy (RRN), Open Radical Nephrectomy (ORN), Open Nephron-sparing Surgery (ONR), or other surgical interventions where it is beneficial to provide temporary vascular occlusion to peripheral organs. [0083] Temporary vascular occlusion of target organs to prevent the influx of solutions (Contrast Medium, Chemotherapy agents) into sensitive organs. [0084] FIG.1 illustrates an exploded view of an exemplary embodiment of an occlusion with perfusion device 100. The occlusion with perfusion device 100 includes a scaffold sheathing catheter 110 and a scaffold catheter 130. The scaffold catheter 130 includes a scaffold catheter shaft 132 with a coupling 134 on the distal most portion. The coupling 134 is modified and adapted for use with the geometry, type, shape and functional characteristics of the scaffold 140. The scaffold 140 includes a scaffold structure 144 and suitable covering 146. In some embodiments, the scaffold structure 144 may be uncovered in which case the covering 146 is omitted. In some embodiments, the scaffold covering 146 may covered scaffold with attached and unattached zones as described further herein. [0085] The scaffold sheathing catheter 110 includes a shaft 115 and a full round distal end section 120 having a distal end 122 and a proximal end 124. The full round distal end section 120 defines a lumen 128 sized to stow or maintain the scaffold 140 in a stowed configuration. Additionally, in use, the full round distal section distal end 122 engages with the scaffold in the deployed configuration and moves it into a stowed configuration within the lumen 128. [0086] The curved shapes of shafts 132, 115 are intended to allow for nesting of and combined movement to and from the treatment site with the stowed scaffold 140 remaining within the lumen 128 of the full round section 120. Additionally, the shafts 132, 115 are in a sliding relation to allow for controlled relative movement of the scaffold 140 and the full round distal end section 120 to allow for transition of the scaffold 140 from/to deployed configuration outside of the full round section 120 and a stowed configuration within the lumen 128 of the full round section 120. [0087] FIG.2 shows the components arranged for use with the shaft sleeve 150 withdrawn from the shafts 115, 132 in order to show their nested relation. Additionally, the scaffold 140 is shown withdrawn proximally from the full round distal end 120 but still in the stowed configuration. Also shown in this view is that the scaffold is nested within the full round distal end lumen 128 and the inner wall of the scaffold sheathing catheter shaft 115. Guidewire 30 is also shown in this view. During movement along the introducer to the aorta, the perfusion with occlusion device 100 moves along the guidewire 30 which is within the lumen 128 and the interior lumen of the scaffold 140. [0088] FIG.3 shows the components of FIG.2 with the scaffold 140 within the lumen 128 which is the configuration for advancing along the introducer and then the vasculature into the position for use within the aorta. [0089] Several different cross section views of the device 100 shown in FIG.3. [0090] FIG.3A is a section view A-A through a portion of the full round [0091] As a direct result of the advantageous nesting and compact arrangement of the components of the occlusion with perfusion device relative to the introducer as shown in FIGs. 3D1 and 3E1, it is to be appreciated that this renders the various embodiments of the occlusion with perfusion system described herein compatible with other cardiac catheterization lab or interventional radiology lab workflow, designed with user-friendly functions and inserted and removed from patient similar to insertion of off-the-shelf introducer sheath with add-on function of temporary peripheral vascular occlusion. The device is an "assist device" which does not interfere with the standard catheterization procedure and comply with the standard activities in the catheterization lab. In one aspect, the peripheral portions of the scaffold catheter and the scaffold sheathing catheter may provide a guiding function to therapy devices advancing along the introducer. By clocking the position of the shaft sleeve or the proximal portions of the shafts (in an embodiment where the adjacency of the catheter shafts are otherwise maintained) the position of the shafts or shaft sleeves will block that portion of the circumference of the distal end of the introducer. Optionally, the shafts may provide a base structure for the manipulation of the vascular intervention device by providing an additional structure to push against or use as a base for manipulation of interventional devices. [0092] The shaft sleeve is only one option for maintaining the nested adjacency of the shafts of the scaffold catheter and the scaffold sheathing catheter. In one aspect, the edges of the catheter shafts may be keyed to maintain adjacency but allow for longitudinal translation. The lower surface of the scaffold catheter and the upper surface of the scaffold sheathing catheter may also be keyed or provided with tab/slot arrangements that will maintain the adjacency while permitting longitudinal movement. Guiding or keying structures may be placed along all or a portion or on particular portions of the shaft length. [0093] FIG.3 illustrates the components of FIGs.1 and 2 with the scaffold based occlusion with perfusion device of FIG.1 arranged with the scaffold catheter shaft alongside the sheathing catheter shaft within the shaft sleeve lumen and the scaffold structure within the lumen of the full round distal end of the scaffold sheathing catheter. A guidewire 30 is shown alongside the shaft sleeve 150 and within the scaffold lumen and exiting the full round distal end lumen 128. [0094] The sheathing catheter 110 has a proximal partial circumference shaft (outer larger circumference within the shaft sleeve) with a full circumference sheath on the distal end. The sheath is sized (a) to be advanced along the introducer interior diameter and (b) hold the scaffold 140 in the stowed configuration. The full round section of the scaffold sheathing catheter 120 is longer than the scaffold 140. The scaffold sheathing catheter 110 has a length ranging from about 110 cm to 145 cm. The introducer sheath has a length ranging from about 45 cm to about 80 cm. In one embodiment, the diameter of the introducer sheath is 7fr which is sized for use in the aorta. In one embodiment, the full round section of the scaffold sheathing catheter has an outer diameter ranging from 2.3mm to 1.67mm with an inner diameter ranging from 2mm to 1mm. [0095] FIGs.3A-3D represent the cross-section views indicated on FIG.3. [0096] FIG.3E is a cross section view of an alternative shaft sleeve 150 having an inner wall that corresponds to the curvature of the scaffold catheter shaft 132. This illustration is an example of nesting the cross-section profiles of the shaft sleeve 150, the scaffold catheter 130 and the scaffold sheathing catheter 110. [0097] FIG.3D1 is a cross section view of a shaft sleeve 150 as in FIG.3D within an introducer lumen 24 representing the shaft sleeve lumen 152 and the remaining portion of the introducer lumen available for use by, for example, a vascular therapeutic device while the shaft sleeve 150 is present. The components within the shaft sleeve 150 are removed for clarity purposes. [0098] FIG.3E1 is a cross section view of a shaft sleeve 150 as in FIG.3E within an introducer lumen 24 representing the shaft sleeve lumen 152 and the remaining portion of the introducer lumen 24 available for use by, for example, a vascular therapeutic device while the shaft sleeve 150 is present. The components within the shaft sleeve are removed for clarity purposes. [0099] While the shaft sleeve 150 is shown at a six o’clock position in Figures 3D-3E1, it will be appreciated that the shaft sleeve may be rotated within the introducer into any other rotational position as needed in support of, for example, the simultaneous use for performing a vascular intervention procedure. [0100] FIG.4 is a profile view of the components of the scaffold occlusion with perfusion device 100 of FIG.1 in relationship to an introducer 20. The scaffold 140 is positioned within the scaffold sheathing catheter 110. A coupler 134 is shown on a distal portion of the scaffold catheter 130. A shaft sleeve 150 is shown proximal to the scaffold sheathing catheter 110. [0101] FIG.5 is an isometric view of the components of the scaffold occlusion with perfusion device 100 of FIG.4 in relationship to the distal end 22 of the introducer 20 as well as exit of the shafts 132, 115 from the distal most end of the shaft sleeve 150. The break portion indicates that the position of the occlusion device may be at the renal ostia while the distal end of the introducer may be positioned to provide access to an aortic arch. A guidewire 30 is positioned along the shaft sleeve 150. [0102] FIG.6 shows the arrangement of the components in FIG.5 with a guidewire 30 positioned beyond the distal end 22 of the introducer 20 and separated from the shaft sleeve 150. [0103] FIG.7A shows the arrangement of the components in FIG.6 with an intravascular device 50 advanced along the guidewire 30. [0104] FIG.7B is a cross section view along section A-A of FIG.7A showing how the interior of the introducer 20 is apportioned between the interventional device 50 and the shaft sleeve 150 and included shafts 110, 130. The relative sizes of the components are exaggerated in this view. In alternative aspects the intervascular device 50 utilizes a greater portion of the introducer lumen interior than those occupied by the shaft sleeve 150. Importantly, in use, the shaft sleeve remains against the interior wall of the introducer lumen such that the lumen accessed by the interventional device 50 is formed by the introducer interior wall not covered by the shaft sleeve 150 and the inner wall of the shaft sleeve (e.g., the wall of the shaft sleeve adjacent to or contacting the interventional device. In another aspect, the shaft sleeve outer wall in conformal to or complementary in shape to the outer wall of the intravascular device. [0105] FIG.8 shows at representative arteries access via a radial artery access procedure. FIG.8 includes the radial artery 214, the brachial artery 206, the subclavian arch 204, the aortic arch 202, the descending aorta 210, the renal arteries 208, 212, the renal artery ostia 218, and the kidneys 216. [0106] FIG.9 shows a guidewire 30 accessing the patient vasculature via the radial artery 214. [0107] FIG.10A is an initial insertion of an introducer 20 and dilator 23 into the radial artery 214 over the guide wire in FIG.9. [0108] FIG.10B is an enlarged view of the introducer 20 and dilator into the radial artery over the guide wire in FIG.10A. [0109] FIG.11A is an overall view of the introducer and dilator of FIG.10B accessing the aortic arch 202 of the patient. FIG.11B is an enlarged view of the introducer 20 and dilator positioned as in FIG.11A. [0110] FIG.12 is an enlarged view of the withdrawal of the dilator 23 leaving the introducer 20 distal end 22 accessing the aortic arch 202. [0111] FIG.13 is an overall view of the withdrawal of the dilator from the access site. [0112] FIG.14 is an overall view of the advancement of the scaffold occlusion with perfusion device 100 of FIG.1 along the guidewire 30 towards the access site. [0113] FIG.15A is an overall view of the advancement of the scaffold occlusion with perfusion device 100 of FIG.14 beyond the distal end 22 of the introducer 20 and accessing the aortic arch 202. [0114] FIG.15B is an enlarged cross section view of FIG.15A showing the components within the aortic arch 202. Shown in 15B are the guide wire 30, the scaffold sheathing catheter 110 and scaffold catheter 130. The scaffold sheathing catheter 110 and scaffold 140 are shown extending out of the distal end 22 of the introducer 20. The shaft sleeve 150 is shown over the sheathing catheter 110 and scaffold catheter 130 within the introducer 20. [0115] FIG.16 shows the continuing advancement of the components in FIG.15B along the guidewire and the aorta. [0116] FIG.17A shows the continuing advancement of the components in FIG.16 along the guidewire and the aorta into position adjacent to the renal artery ostia 218. In this position the full round section 120 of the scaffold sheathing catheter containing the stowed scaffold is alongside the ostia. [0117] FIG.17B is an enlarged view of the arrangement of the components in FIG.17A. The scaffold 140 is positioned within the full round section 120 of the scaffold sheathing catheter. The scaffold sheathing catheter 110 and scaffold catheter 130 are shown extending through the shaft sleeve 150. [0118] FIG.18A is an overall view of the continuing advancement of the components in FIG.17B as the full round distal section 120 of the scaffold sheathing catheter 110 is withdrawn proximally. The distal most portion of the scaffold is shown beginning the transition to the deployed configuration to at least partially occlude the renal ostia 218. [0119] FIG.18B is an enlarged view of the arrangement of the components in FIG.18A as the full round distal section 120 of the scaffold sheathing catheter 110 continues to be withdrawn proximally. The distal most portion of the scaffold 140 is shown beginning the transition to the deployed configuration to at least partially occlude the renal ostia. [0120] FIG.18C is an overall view of the arrangement of the continuing advancement of the components in FIG.18B as the full round distal section 120 of the scaffold sheathing catheter 110 continues to be withdrawn proximally. An additional portion of the distal most portion of the scaffold 140 is transitioning into the deployed configuration to at least partially occlude the renal ostia. [0121] FIG.18D is an enlarged view of the arrangement of the components in FIG.18C as the full round distal section 120 of the scaffold sheathing catheter 110 has been withdrawn proximally beyond the coupling 134. In this view the scaffold 140 is fully transitioned into the deployed configuration to at least partially occlude the renal ostia 218. [0122] FIG.18E is an enlarged view of the arrangement of the scaffold 140 and the scaffold sheathing catheter 110 while the scaffold 140 is providing occlusion with distal perfusion. In this view the scaffold 140 or scaffold covering 146 is distended into the renal ostia 218. [0123] FIG.18F is an enlarged view of the arrangement of the scaffold 140 and the scaffold sheathing catheter 110 while the scaffold sheathing catheter is being withdrawn. In this view the scaffold 140 or scaffold covering 146 is providing occlusion with distal perfusion but is not distended into the renal ostia 218. [0124] FIG.18G is an overall view of the arrangement of the scaffold 140 and the scaffold sheathing catheter 110 while the scaffold 140 is providing occlusion with distal perfusion as in FIG.18E showing the withdrawal of the guidewire 30 to prepare for the introduction of an interventional device in conjunction with the use of the scaffold occlusion device. [0125] FIG.18H represents the continued withdrawal of the guidewire 30. [0126] FIG.18I is an enlarged view of the repositioning of the guidewire 30 while adjacent to the shaft sleeve 150 and within the same introducer 20. [0127] FIG.18J is an overall view of the repositioned guidewire 30 for guiding an intervascular device to be used in a procedure accessed using the same introducer 20 and simultaneously with the scaffold occlusion device. [0128] FIG.19A shows placement of the intervascular device onto the guidewire 30 positioned in FIG.18J. The intervascular device will be used in a procedure accessed using the same introducer and simultaneously with the scaffold occlusion device. [0129] FIG.19B is a partial cross section and exploded view of the arrangement of the scaffold components above alongside the intervascular device 50 as it is advanced along the guidewire 30 positioned as in FIG.18J. [0130] FIG.19C is an overall view of the components in FIG.19A accessing the aortic arch 202. [0131] FIG.19D is the enlarged view of the components in FIG.19C accessing the aortic arch 202 with the intervascular device exiting the same introducer used for the scaffold occlusion device while the scaffold device is present and adjacent to the renal arteries. [0132] FIGs.20A and 20B are perspective views of an alternative scaffold structure 140 using deflectable rings 2202 on the scaffold catheter 130. FIG.20A illustrates the rings 2202 in a deployed configuration. FIG.20B represents the rings 2202 in a stowed condition as would be within the full round distal section (See FIG.3) [0133] FIGs.20C and 20D illustrate the rings 2202 of FIG.20A and 20B with a scaffold covering 146 in place that extends between the rings 2202. [0134] FIGs.21A-21C represent the delivery of an embodiment of the rings 2202 in FIG. 20C within the aorta to occlude the renal ostia 218. [0135] FIG.22A is an embodiment of the rings 2202 in FIG.20C where the scaffold covering 146 only extends about 270 degrees around the rings 2202. This embodiment is deployed in the aorta in the view of FIG.22C and in the cross section view of FIG.22E. [0136] FIG.22B is an embodiment of the rings 2202 in FIG.20C where the scaffold covering 146 only extends about two partial segments around the rings 2202. This embodiment is deployed in the aorta in the view of FIG.22D and in the cross section view of FIG.22F. [0137] FIGs.23A and 23B are perspective views of an alternative scaffold structure 140 using deflectable rings 2202 on the scaffold catheter 130 of different sizes. FIG.23A illustrates the rings 2202 in a deployed configuration with a larger diameter proximal ring than the distal ring. FIG.23B represents the rings 2202 in a stowed condition as would be within the full round distal section (See FIG.3) [0138] FIGs.23C and 23D illustrate the rings 2202 of FIG.23A and 23B with a scaffold covering 146 in place that extends between the rings 2202. [0139] FIG.23E represents the delivery of an embodiment of the rings 2202 in FIG.23C within the aorta to occlude the renal ostia 218. [0140] FIG.24A is a scaffold structure 140 that extends along the scaffold catheter 130 responsive to the movement of the full round distal end. FIG.24B is the scaffold structure of FIG.24A when deployed. [0141] The scaffold structure 140 of FIG 24A can comprise a fixed coupler 2404 and a floating coupler 2402. The The catheter 130 may have an atraumatic catheter distal tip 2406 (e.g., knob, protrusion, etc.) or other radially extending element at its distal end. The distal tip 2406 can be configured to limit the distal movement of the scaffold 140 along the scaffold catheter. [0142] The scaffold sheathing catheter round distal end constrains the scaffold structure when the scaffold structure is positioned within the scaffold sheathing catheter. Once the full round distal end portion of the scaffold sheathing catheter is withdrawn, the scaffold 140 can move and change shape from an elongated, small diameter collapsed configuration to a shortened, larger diameter expanded configuration. [0143] The scaffold structure can comprise a stent like structure. The stent like structure can comprise a plurality of intersecting struts. In some embodiments, the scaffold structure is non- woven. In other embodiments, the scaffold structure may be woven. [0144] FIG.24C is the scaffold device 140 of FIG.24A adjacent to the renal ostia 218. [0145] FIG.24D is the scaffold structure of FIG.24B in position to occlude the renal ostia 218 once the full round section has been withdrawn. [0146] FIG.25A is a scaffold structure 140 that extends along the scaffold catheter 130 responsive to the movement of the full round distal end. A coil structure 2502 within the covering 146 is extended while stowed. The coil structure 2502 extends between ends 2504. FIG.25B is the scaffold structure 140 of FIG.25A when deployed by allowing the coil structure 2504 to move when unconstrained by the full round section. When unconstrained, the coil structure 2504 can decrease in length and increase in diameter. [0147] FIG.25C is the coil scaffold structure 140 of FIG.25B in position to occlude the renal ostia 218 constrained by the full round section 120. [0148] FIG.25D is the scaffold structure of FIG.25C in position to occlude the renal ostia in a deployed configuration since the full round section has been withdrawn. [0149] FIG.26 is a flow chart of an exemplary method of providing occlusion with perfusion using an embodiment of a vascular occlusion device herein according to the method 2600. [0150] First, at step 2605, there is the process of accessing an aortic arch with an introducer via a radial artery. In one illustrative embodiment, the introducer is used to access the right radial artery. It is to be appreciated that the techniques and devices described herein may be adapted to introduction via the right radial artery or other vascular access site depending on the intravascular procedure to be performed in combination with an embodiment of an occlusion with perfusion device. [0151] Next, at step 2610, there is a process of advancing an occlusion with perfusion scaffold device through the introducer to a position adjacent to a renal artery ostium. At this point, the occlusion with perfusion device is in position but in a stowed condition. Additionally or optionally, the occlusion with perfusion device may be transitioned into the deployed position before or during the steps of the intervention (step 2620) or wait until the use of imaging contrast (step 2625). [0152] Next, at step 2615, there is a process of advancing a vascular intervention device through the introducer to a vascular intervention site. [0153] Next, at step 2620, there is a process of performing a vascular intervention at the vascular intervention site using the vascular intervention device. [0154] Next, at step 2625, there is a process of transitioning the occlusion with perfusion scaffold device into an occlusion configuration to occlude the renal ostia before delivery of an imaging contrast agent in support of the vascular intervention. [0155] Next, at step 2630, there is a method of transitioning the occlusion with perfusion scaffold device into a stowed condition after delivery of the imaging contrast agent. [0156] Next, at step 2635, there is a process of repeating steps 2625 and 2630 for any additional uses of imaging contrast agent during the vascular intervention. [0157] Next, at step 2640, there is a process of withdrawing the vascular intervention device via the introducer after completion of the vascular intervention. [0158] Next, at step 2645, there is a process of withdrawing the occlusion with perfusion scaffold device. [0159] FIG.27 is a flow chart of an exemplary method of providing occlusion with perfusion using an embodiment of a vascular occlusion device according to the method 2700. [0160] First, at step 2705, there is a process of accessing an aortic arch with an introducer via a radial artery. [0161] Next, at step 2710, there is a process of advancing an occlusion with perfusion scaffold device through the introducer to a position adjacent to a renal artery ostium. Additionally or optionally, the occlusion with perfusion device may be transitioned into the deployed position before or during the steps of the intervention (step 2720) or wait until the use of imaging contrast (step 2725). [0162] Next, at step 2715, there is a process of advancing a vascular intervention device through the introducer to a vascular intervention site. [0163] Next, at step 2720, there is a process of performing a vascular intervention at the vascular intervention site using the vascular intervention device. [0164] Next, at step 2725, there is a process of withdrawing a scaffold sheathing catheter to transition the occlusion with perfusion scaffold device into an occlusion configuration to occlude the renal ostia before delivery of an imaging contrast agent in support of the vascular intervention. [0165] Next, at step 2730, there is a process of transitioning the occlusion with perfusion scaffold device into a stowed condition after delivery of the imaging contrast agent by advancing the scaffold sheathing catheter over the occlusion with perfusion scaffold device. [0166] Next, at step 2735, there is a process of repeating steps 2625 and 2630 for any additional uses of imaging contrast agent during the vascular intervention. [0167] Next, at step 2740, there is a process of withdrawing the vascular intervention device via the introducer after completion of the vascular intervention. [0168] Next, at step 2745, there is a process of withdrawing the occlusion with perfusion scaffold device. [0169] In one aspect, embodiments of the various handle structures described in International Application Number PCT/US2021/020550 entitled “INTRODUCER HAVING CONTROLLABLE OCCLUSION WITH PERFUSION CAPABILITIES” having an international filing date of March 2, 2021 may be modified for use to provide advancement and withdrawal of the occlusion with perfusion device along the introducer lumen and the vasculature as well as to provide for relative movement between the scaffold and the full round portion of the distal end of the scaffold sheathing catheter. Additionally or optionally, the handle 1550 described in that application is configured to provide the controlled and repeated transition of the scaffold or occlusion with perfusion device between a stowed condition within a suitable structure at the distal end of the of the scaffold sheathing catheter and a deployed condition where the scaffold structure is capable of providing occlusion of peripheral vascular structures while allowing perfusion of distal vascular structures. In a similar way, the additional handle embodiments described in International Application Number PCT/US2021/020550 entitled “INTRODUCER HAVING CONTROLLABLE OCCLUSION WITH PERFUSION CAPABILITIES” having an international filing date of March 2, 2021, such as in FIGs.35, 42, 43, 68A, 68B and 68D may be adapted for this purpose. Still further, and optionally, aspects of the handle described in U.S. Patent 5,507,768 may be adapted for use in some embodiments described herein. [0170] In some alternative embodiments, the covered scaffold structures of FIGs.1, 2, 18A- 18H, 20C, 20D, 21A-22F, 23C-E, and 24A-25C described herein may be adapted to billow or deform in response to blood flow pressure through the device as shown and described in FIGs. 44A-44C of International Application Number PCT/US2021/020550 entitled “INTRODUCER HAVING CONTROLLABLE OCCLUSION WITH PERFUSION CAPABILITIES” having an international filing date of March 2, 2021. More particularly, a covered scaffold structure or a vascular occlusion with perfusion device embodiment so configured when positioned for occlusion of the renal arteries and perfusion of the arterial tree in the lower extremities would permit distention or bulging of any unattached portions of the scaffold covering in response to the blood flow pressure generated within the scaffold. [0171] Additionally or optionally, the scaffold catheter, scaffold device (i.e., an embodiment of an occlusion with perfusion device) and the scaffold sheathing catheter may be modified or adapted for use as described in International Application Number PCT/US2021/020550 entitled “INTRODUCER HAVING CONTROLLABLE OCCLUSION WITH PERFUSION CAPABILITIES” having an international filing date of March 2, 2021. More specifically, such modification includes a procedure for diagnosis or treatment of a coronary artery 320 by use of a diagnostic instrument or a therapeutic instrument through the introducer sheath and occlusion with perfusion device according to a suitable embodiment described with reference to FIG.6 of that application. In various alternative embodiments, one or more of these steps may be modified by one or more of the steps described in method 800 in FIG.8 of that application. Still further, in FIG.55 of that application, there is a schematic illustration of a condition in which the introducer sheath and occlusion with perfusion device is inserted in a predetermined blood vessel of a patient 300. The steps of this method may be modified to advantageously employ the embodiments of the scaffold, scaffold catheter and scaffold sheathing catheter as described herein. [0172] Additionally or optionally, a covering may be attached to a scaffold embodiment as described in International Application Number PCT/US2020/052899 entitled “DEVICES AND METHODS FOR AT LEAST PARTIALLY OCCLUDING A BLOOD VESSEL WHILE MAINTAINING DISTAL PERFUSION” having an international filing date of September 25, 2020, in particular with regard to the use of single or multiple layer coverings as well as scaffold encapsulation methods and attachment by folding over the ends of the covering onto scaffold structures. As such, in some embodiments of the present invention, there may also be attached and unattached zones between a covering and a scaffold structure. In particular with regard to the embodiments of FIGs.20C and 23C, the covering may be attached to the circumference of the proximal and distal rings using the folded over attachment method described above. Similarly, the folded over attachment method with varying amounts of overlap may be incorporated in scaffold-covering embodiments to provide a variety of overlap and single covering combinations. [0173] Exemplary Simultaneous Combination Vascular Access and Occlusion with Perfusion Devices [0174] The various alternative configurations and capabilities of the perfusion with occlusion device and combination occlusion with access device may be sized for a variety of applications and different vascular procedures. In one aspect, for example, intravascular devices 50 sized in a range from 5 Fr to 8Fr (0.065 to 0.105 inches) or may range from 4Fr to 7Fr (0.053 to 0.092 inches) depending on the particular procedure may simultaneously access the vasculature using the same introducer as used for the occlusion scaffold device. [0175] In still additional alternative embodiments, the intravascular device 50 may advantageously utilize the shafts of the scaffold catheter and/or the sheathing catheter as a base of support during the interventional or therapeutic procedure being performed while the occlusion with perfusion device is present in the vasculature. The relationship between the intravascular device 50 and the shafts 115, 132 or the shaft sleeve 150 is represented in the views of FIGs.17A and 19D. Both the occlusion device proximal portion and the intravascular device are present together at the distal end of the introducer. One advantage of the reduced shaft profile of embodiments of the occlusion with perfusion device is the shared introducer lumen design. This design concept provides for a sharing between the shaft of the deployed occlusion with perfusion device and the catheter or access for the interventional device. The relative position of the intravascular device with respect to the occlusion with perfusion device is seen, by way of example and not limitation, in FIGs.7A, 7B, as well as with reference to the general positions within the introducer lumen as shown in FIGs.3D1 and 3E1. In use, this design attribute may be used with advantage by adjusting the position of the shafts 115, 132 or the shaft sleeve 150 relative to the introducer lumen. Since the shafts 115, 132 and the shaft sleeve 150 are free to move within the introducer lumen they may be placed along any aspect of the lumen interior into any of a number of positions as if the interior of the introducer lumen were a clock face. By way of example using this nomenclature, the shafts 115, 132 and the shaft sleeve 150 would be in the 6 o'clock position in the view of FIG.7A. Also in this view and this exemplary scale of the drawings, the shafts 115, 132 or the shaft sleeve 150 occupy roughly from the 4 o'clock position to the 8 o'clock position. As a result, in this illustrative embodiment, the intravascular device has the remainder of the introducer interior – from 4 o'clock to 12 o'clock to 8 o'clock in which to operate. [0176] In one embodiment of a combined method of coordinated operations, the occlusion with perfusion device may be rotated in a variety of different support positions relative to the intravascular procedure being performed. In one aspect, the shafts 115, 132 or the shaft sleeve 150 are rotated to block access to a portion of the vasculature to be avoided. In this way, the open or accessible portion of the lumen may be oriented so that when exiting the introducer lumen the intravascular device is blocked in certain areas. In another embodiment, the shafts 115, 132 or the shaft sleeve 150 are rotated with respect to the distal end of the introducer such that the shafts 115, 132 or the shaft sleeve 150 are used act as a guide to direct the placement of the intravascular device. In yet another embodiment, the shafts 115, 132 or the shaft sleeve 150 are rotated with respect to the distal end of the introducer such that the shafts 115, 132 or the shaft sleeve 150 are used act as a guide to direct the placement or block the movement of the intravascular device and then, during the intravascular procedure, the shafts 115, 132 or the shaft sleeve 150 are moved into a different position so as to act as a base of support for tools or devices or movement of the intravascular device during the intravascular procedure. [0177] It is to be appreciated that alternative embodiments of the methods 2600 and 2700 may be provided in furtherance of the combined use methods described herein. The combinations of employing the shafts and/or shaft sleeve in a blocking mode, guiding mode or supporting mode may performed in conjunction with other steps in the methods 2600 and 2700. Exemplary steps in such a modified method may include rotating the shafts 115, 132 or the shaft sleeve 150 within the introducer lumen relative to a portion of the intravascular device so that in use a portion of the shafts 115, 132 or the shaft sleeve 150 (a) selectively blocks movement of the intravascular device in a portion of the introducer lumen; (b) guides the movement of the intravascular device relative to the introducer lumen; and/or (c) support the use of the intravascular device during the intravascular procedure or intervention. It is to be appreciated as well that in some embodiments there is a dynamic interplay between the shafts 115, 132 or the shaft sleeve 150 and the intravascular device that one, two or all three of these combinational use modes may be used during a given procedure. In one alternative embodiment, one or more of the steps of methods 2600 and 2700 are modified to include performing one or more steps of a vascular intervention by an interplay of blocking, guiding or supporting the intravascular device using one or a combination of the shafts 115, 132 or the shaft sleeve 150. [0178] It is to be appreciated that the type of scaffold structure and covering placement may be selected based on the type of combined methods to be practiced. In particular, scaffold and covering designs which, in use, generally cover the vessel lumen interior may find greater utilization in the various combined techniques listed above. Non-limiting examples include those covered scaffold embodiments illustrated and described with respect to FIGs.18A-18H, 20C, 21C, 23C, 23E, and 24A-25D. [0179] Additional aspects of the design, structure, utilization and alternative configurations of temporary occlusion with distal perfusion devices are provided in the following applications commonly assigned to the assignee of the present application, each of which is incorporated by reference for all purposes: [0180] International Application Number PCT/US2014/072302 entitled “DEVICES AND METHODS FOR TREATING ACUTE KIDNEY INJURY” having an international filing date of December 23, 2014; International Application Number PCT/US2017/031153 entitled “DEVICES AND METHODS FOR TREATING ACUTE KIDNEY INJURY” having an international filing date of May 4, 2017; International Application Number PCT/US2019/038310 entitled “MULTI-CHAMBERED BALLOON CATHETER DEVICES AND METHODS” having an international filing date of June 20, 2019; International Application Number PCT/US2020/052899 entitled “DEVICES AND METHODS FOR AT LEAST PARTIALLY OCCLUDING A BLOOD VESSEL WHILE MAINTAINING DISTAL PERFUSION” having an international filing date of September 25, 2020; and International Application Number PCT/US2021/020550 entitled “INTRODUCER HAVING CONTROLLABLE OCCLUSION WITH PERFUSION CAPABILITIES” having an international filing date of March 2, 2021. [0181] Various exemplary embodiments of the invention are described herein. Reference is made to these examples in a non-limiting sense. They are provided to illustrate more broadly applicable aspects of the invention. Various changes may be made to the invention described and equivalents may be substituted without departing from the true spirit and scope of the invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process act(s) or step(s) to the objective(s), spirit or scope of the present invention. Further, as will be appreciated by those with skill in the art that each of the individual variations described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present inventions. All such modifications are intended to be within the scope of claims associated with this disclosure. [0182] Any of the devices described for carrying out the subject diagnostic or interventional procedures may be provided in packaged combination for use in executing such interventions. These supply "kits" may further include instructions for use and be packaged in sterile trays or containers as commonly employed for such purposes. [0183] The invention includes methods that may be performed using the subject devices. The methods may comprise the act of providing such a suitable device. Such provision may be performed by the end user. In other words, the "providing" act merely requires the end user obtain, access, approach, position, set-up, activate, power-up or otherwise act to provide the requisite device in the subject method. Methods recited herein may be carried out in any order of the recited events which is logically possible, as well as in the recited order of events. [0184] Exemplary aspects of the invention, together with details regarding material selection and manufacture have been set forth above. As for other details of the present invention, these may be appreciated in connection with the above-referenced patents and publications as well as generally known or appreciated by those with skill in the art. For example, one with skill in the art will appreciate that one or more lubricious coatings (e.g., hydrophilic polymers such as polyvinylpyrrolidone-based compositions, fluoropolymers such as tetrafluoroethylene, hydrophilic gel or silicones) may be used in connection with various portions of the devices, such as relatively large interfacial surfaces of movably coupled parts, if desired, for example, to facilitate low friction manipulation or advancement of such objects relative to other portions of the instrumentation or nearby tissue structures. The same may hold true with respect to method- based aspects of the invention in terms of additional acts as commonly or logically employed. [0185] In addition, though the invention has been described in reference to several examples optionally incorporating various features, the invention is not to be limited to that which is described or indicated as contemplated with respect to each variation of the invention. Various changes may be made to the invention described and equivalents (whether recited herein or not included for the sake of some brevity) may be substituted without departing from the true spirit and scope of the invention. In addition, where a range of values is provided, it is understood that every intervening value, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the invention. [0186] Also, it is contemplated that any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein. Reference to a singular item, includes the possibility that there are plural of the same items present. More specifically, as used herein and in claims associated hereto, the singular forms "a," "an," "said," and "the" include plural referents unless the specifically stated otherwise. In other words, use of the articles allow for "at least one" of the subject item in the description above as well as claims associated with this disclosure. It is further noted that such claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as "solely," "only" and the like in connection with the recitation of claim elements, or use of a "negative" limitation. [0187] Without the use of such exclusive terminology, the term "comprising" in claims associated with this disclosure shall allow for the inclusion of any additional element-- irrespective of whether a given number of elements are enumerated in such claims, or the addition of a feature could be regarded as transforming the nature of an element set forth in such claims. Except as specifically defined herein, all technical and scientific terms used herein are to be given as broad a commonly understood meaning as possible while maintaining claim validity. [0188] The breadth of the present invention is not to be limited to the examples provided and/or the subject specification, but rather only by the scope of claim language associated with this disclosure. [0189] When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature. [0190] Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature’s relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise. [0191] Although the terms “first” and “second” may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention. [0192] Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps. [0193] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/- 0.1% of the stated value (or range of values), +/- 1% of the stated value (or range of values), +/- 2% of the stated value (or range of values), +/- 5% of the stated value (or range of values), +/- 10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed. [0194] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims. [0195] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description. [0196] Although preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein can be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.