WO2025196742A2

WO2025196742A2 - Devices, methods, and systems for reducing air in a delivery

Info

Publication number: WO2025196742A2
Application number: PCT/IB2025/055318
Authority: WO
Inventors: John Mogensen; Simon Voigt Andersen; Erik E. Rasmussen; Adria Rodriguez Paz; Bent øHLENSCHLAEGER
Original assignee: Cook Medical Technologies LLC
Current assignee: Cook Medical Technologies LLC
Priority date: 2024-03-22
Filing date: 2025-05-22
Publication date: 2025-09-25
Anticipated expiration: 2026-09-22
Also published as: WO2025196742A3

Abstract

A delivery device system and method for delivering an endoluminal prosthesis to patient. The delivery device has an inner cannula; a prosthesis retention region in a proximal region of the delivery device; a positioner catheter disposed at least partially coaxially over the inner cannula and having an inner lumen, a sidewall and a hole disposed within the side wall; a sheath hub having an inner chamber configured to receive flushing fluid from a flushing port in fluid communication with the inner chamber; a sheath disposed at least partially coaxially over the positioner, the inner cannula, and the prothesis retention region and extending from a proximal end of the sheath hub, the sheath having an open distal end in fluid communication with the inner chamber; an annular space between the inner cannula and the positioner in fluid communication with the inner chamber and the hole; and an annular space between the positioner and the sheath in fluid communication with the inner chamber and the hole. Upon injection of a flushing fluid into the inner chamber annular space between the positioner and the sheath is configured to receive fluid from the chamber and the annular space between the inner cannula and the positioner and the lumen of the positioner are configured to receive fluid from the chamber through the hole whereby residual air in the system is reduced. A method for reducing air in the delivery system is also provided.

Description

DEVICES, METHODS, AND SYSTEMS FOR REDUCING AIR IN A DELIVERY

SYSTEM

TECHNICAL FIELD

[001] The present disclosure relates generally to methods of reducing air in medical devices, and, more particularly, to methods for flushing trapped air from stent graft delivery devices, catheters, heart valves, heart valve delivery devices or other medical devices.

BACKGROUND

[002] Endovascular methods have been proposed for treatment of diseases of the aorta such as aortic dissections, aortic aneurysms, defective heart valves and the like. Using prostheses, such as stent grafts, to treat aneurysms, dissections and defective heart valves is common in the medical field. Stent grafts, stents, and heart valves are deployed using device delivery systems by accessing a vasculature with a small incision in the skin, guiding a delivery system to the target area, and deploying the device. This endoluminal delivery is less invasive and generally preferred over more intrusive forms of surgery.

[003] Endoluminal delivery systems are known to carry trapped air in the various spaces of the delivery system. When introduced into the patient, the trapped air may cause air embolism within the patient. Air emboli that may be introduced during endovascular methods can be detrimental to a patient's outcome, often attributing to additional complications such as ischemia in the brain arterial system. In addition, there is a higher risk of air embolism with trapped air within the delivery systems, especially in larger bore devices, such as greater than 16 Fr and long delivery systems. In particular, retained air in endovascular systems, particularly those that are implanted close to the aortic arch branches, for example thoracic devices, thoracoabdominal devices, arch devices, ascending aorta devices, and heart valves, has the potential risk of causing ischemia in the brain arterial system. In addition, the blood/gas interface can cause coagulation, inflammation and vasogenic edema which can subsequently lead to cytotoxic brain edema.

[004] Conventionally, before such deployment systems are introduced into a patient, saline/heparinaised saline is be introduced for flushing aspects of the delivery system to reduce the amount of trapped air. Even so, more care must be taken to further reduce the amount of trapped air from stent graft and delivery systems systems in order to minimize any potential risk of air emboli into the patient's vasculature. Further, air release from endovascular devices has led to the use of CO2 or other inert gases for the flushing of devices prior to flushing with heparinized saline. See for example, US Patent No. 11,311,396 to Kolbel, “Systems and Methods For Removing Air From Medical Devices,” the entire contents of which are incorporated herein by reference. It is generally perceived by doctors that CO2 is a less harmful gas and is also more easily dissolved in the bloodstream compared to ambient air. However, there are still parts of a delivery system that are difficult to flush.

[005] For example, saline and/or CO2 have been used to flush delivery systems by injecting the flushing fluid into the inner cannula through a port at the distal end of the delivery system and/or flushing the sheath through a sheath port. However, in these systems, it has been found that fluid will not enter the lumen of the positioner of the delivery system. In another system, a third flush port was provided to flush the space between the positioner catheter and inner cannula, utilizing both CO2 followed by saline, which did provide reduction in residual air in the system. See, US Patent No. 11,135,077 to Kratzberg, et. al., “Method of Air Reduction in Stent Graft Delivery Device”, the entire contents of which are incorporated herein by reference. However, the addition of a port and an added flushing step makes the system and procedure more complex, adding to the complexity of the flushing procedure as well as the manufacture of the delivery device.

BRIEF SUMMARY OF SELECTED EXAMPLES [006] The present disclosure relates generally to methods of reducing air in medical devices, and, more particularly, to methods for flushing trapped air from endoluminal prostheses, such as grafts, stent grafts, heart valves, and the like, endovascular prothesis delivery devices for those devices, catheters or other medical devices. The inventors here have found that the present inventive device, system and methods, utilizing a single flush port which is in fluid connection with a single hole connecting the spaces between the positioner lumen and the space between the pusher and the sheath, and hence flushing the lumen of the positioner, the annular space between the sheath and the positioner, the interior of the prosthesis, and the annular space between the inner cannula and the positioner, unexpectedly and surprisingly reduces air in the device up to 97 % and as low as 0.01 ml. In other words, providing a single hole that connects these spaces unexpectedly and significantly reduces residual air in the system and, hence, air that could reach the patient as discussed above.

[007] The invention provides delivery device for delivering an endoluminal prosthesis, where the delivery device has reduced residual air. The device includes a proximal end; distal end; an inner cannula extending through the delivery device and having a proximal end, a distal end, and an inner lumen therebetween, the inner lumen configured to receive at least one wire guide; a prosthesis retention region in a proximal region of the delivery device; a positioner catheter disposed at least partially coaxially over the inner cannula and having an inner lumen, a sidewall and a hole disposed within the side wall; a sheath hub having an inner chamber configured to receive flushing fluid from a flushing port in fluid communication with the inner chamber; a sheath disposed at least partially coaxially over the positioner, the inner cannula, and the prothesis retention region and extending from a proximal end of the sheath hub, the sheath having an open distal end in fluid communication with the inner chamber; an annular space between the inner cannula and the positioner in fluid communication with the inner chamber and the hole; an annular space between the positioner and the sheath in fluid communication with the inner chamber and the hole; wherein upon injection of a flushing fluid into the inner chamber, the annular space between the inner cannula and the positioner and the annular space between the positioner and the sheath are both configured to receive fluid from the chamber through the hole; and wherein subsequent to the injection of the flushing fluid, air in the delivery device is reduced.

[008] A delivery device for delivering an endoluminal prosthesis to patient having reduced residual air, as above, wherein the hole in the positioner is disposed within the chamber; wherein upon injection of a fluid into the inner chamber, the annular space between the inner cannula and the positioner and the annular space between the positioner and the sheath are both configured to receive fluid from the chamber through the hole; and wherein subsequent injection of the flushing fluid, air in the delivery device is reduced.

[009] A method of removing residual air from a delivery device for an endoluminal prosthesis is also provided. The method may include providing a delivering device as above, injecting a first flushing fluid through the flushing port and into the chamber and the hole, wherein upon injection of the flushing fluid into the inner chamber, fluid flows from the chamber into the annular space between the positioner and the sheath from the chamber and the annular space between the inner cannula and the positioner from the chamber by way of the hole in the positioner, thereby reducing the air in the delivery system.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Selected example embodiments of the invention are described below with reference to the accompanying drawings, in which:

[0011] FIG. 1 shows a cross-section of a conventional system and the direction of flow of flushing fluid from a flushing entry port;

[0012] FIG. 2 is a schematic view of a conventional system showing flushing fluid from the flushing entry port and its location and direction of fluid flow;

[0013] FIG. 3 is a cross-section of a conventional delivery device;

[0014] FIG. 4 is another schematic view of a conventional device showing the direction of fluid after injection of the flushing fluid into the delivery device;

[0015] FIG. 5 shows a side view of an exemplary stent graft delivery device for use with the present invention.

[0016] FIG. 6 shows another side view of the stent graft delivery device for use with the present invention.

[0017] FIGS. 7 and 8 are partial side views of a delivery device with a first embodiment of the present invention.

[0018] FIG. 9 is a partial side view of the delivery device of FIGS. 7 and 8. [0019] FIG. 10 is a schematic side view of a second embodiment of the present invention.

[0019] FIG. 11 is a partial side view of the sheath hub housing of a delivery device with the second embodiment of the present invention.

[0020] FIGS. 12-16 show alternative views of flushing apertures of the present invention.

[0021] FIG. 17 is a cross-sectional view of a positioner/pusher catheter of the embodiments of the present invention.

[0022] FIG. 18 is a partial side view of a positioner/pusher catheter with a deployment assist device.

[0023] FIGS. 19 and 20 are partial side views of a positioner/pusher catheter with a deployment assist device according to an aspect of the present invention.

[0024] FIG. 21 is a chart comparing residual air in devices with and without various aspects of the present invention.

[0025] FIGS. 22-23 show representations of the volume of residual air from the chart of FIG. 21. [0026] FIG. 24 is a chart comparing residual air in devices with and without various aspects of the present invention.

[0027] FIGS. 25-26 is a chart comparing residual air in devices with and without various aspects of the present invention.

[0028] FIG. 27 is a flowchart illustration of an example method of removing residual air from a delivery device for an endoluminal prosthesis.

[0029] FIG. 28 is a flowchart illustration of another example method of removing residual air from a delivery device for an endoluminal prosthesis.

DETAILED DESCRIPTION OF SELECTED EXAMPLES

[0030] Described below are preferred embodiments of medical devices and methods according to teachings herein. It is to be understood that the drawings are not to scale and are intended to be merely illustrative of the features and elements of the device and its components.

[0031] Described herein are methods for reducing air within prosthesis delivery devices by flushing various lumens. Accordingly, any potential risk of air emboli related events and complications that may occur during endovascular procedures is reduced. With the prescribed devices, systems, and methods, substantial amounts of air may be removed from major air containing regions of a delivery device: an outer sheath, an inner catheter, a wire guide catheter, and the spaces therebetween. In particular, the inner catheter (also referred to as the positioner or pusher catheter) is disposed within an outer sheath and coaxially over the wire guide catheter (also called the inner cannula). The outer sheath extends from a hub that includes a flushing port, while the wire guide may include another flushing port at the distal end of the wire guide catheter. The use of a flushing fluid, such as saline, and/or and inert high blood soluble gas, such as carbon dioxide, in the ports has been found beneficial in driving out the majority of the air within the delivery device with a single flushing port for the sheath, the positioner lumen, the area between the sheath and the positioner, and the area between the positioner and inner cannula. Additionally, a port in fluid communication with the inner cannula may be used to flush the inner cannula lumen.

[0032] Throughout this specification, the term proximal with respect to both human or animal vasculature will be used to refer to the region closest to the heart and, similarly, the part of the implantable medical device that is closest to the heart when in use. The term distal will be used for the regions of the human or animal vasculature further from the heart and, similarly, those parts of the implantable medical device that are further from the heart when in use. With regard to a deployment or introducer assembly or retrieval device, the term distal is also used to denote the part of the assembly that remains closest to the clinician during the medical procedure and typically outside the patient. The term proximal is also used to denote the end of the assembly that is furthest from the clinician, which is first fed endoluminally into the patient’s vasculature. Proximal may also be used to designate an inflow end of an endoluminal prosthesis and distal may also be used to designate an outflow end of an endoluminal prosthesis. A proximal direction is a direction that would cause an object to assume a more proximal position. A distal direction is a direction that would cause an object to assume a more distal position.

[0033] “Residual Air” is defined as air remaining in the delivery system after flushing it with saline. “Residual air release” is defined as air remaining in the delivery system after flushing it with saline that is released to the patient during deployment of the stent-graft.

[0034] FIG. 1 shows a partial cross-section of a conventional system and the direction of flow of flushing fluid from the flushing entry port. As shown, the portion of the delivery system 10 shown includes a sheath hub housing 12, flushing chamber 14 within the housing 12, inner cannula 16 (also called a guide wire/wire guide catheter) extending through the housing 12 and having an inner lumen 18, positioner 20 having an inner lumen 22, where the positioner 20 is coaxially disposed over the inner cannula 16 to define an annular space 24 between the inner cannula 16 and the positioner 20, sheath 26 extending from the proximal end 28 of the housing 12 and having an open distal end 30 in fluid communication with the chamber 14. Sheath 26 is at least partially coaxially disposed over the positioner 20 to define an annular space 32 between the sheath 26 and the positioner 20. Sheath 26 extends proximally from the proximal end 28 of the sheath hub housing 12. In this device, flushing fluid (shown by arrows 34) is introduced prior to introduction of the delivery device to the patient into the chamber 14 of the housing 12, enters the open distal end 30 of the sheath 26, enters the annular space 32 between the sheath 26 and the positioner 20, and exits out of the proximal end (not shown) of the delivery device 10.

[0035] FIG. 3 shows the coaxial relationship of the inner cannula 16, the inner cannula lumen 18, the positioner lumen 22, the annular space 24 between the inner cannula 16 and the positioner 20, the positioner 20, the sheath 26 and the annular space 32 between the sheath 26 and the positioner 20.

[0036] FIG. 2 is a partial schematic view of a conventional system showing flushing fluid flowing through the annular space 32 between the sheath 26 and the positioner 20 and entering the prothesis (for example, a stent graft, stent or heart valve replacement) region 36 with the direction of fluid flow indicated by arrows 34. As shown, fluid flows from the entry point (not shown), through the annular space 32, into the prosthesis region 36 and out of the open proximal end 38 of the sheath 26. As shown in FIG. 4, another partial schematic view of a conventional device showing the direction of fluid, although fluid flows distally to proximally, as indicated by arrows 34, through the annular space 32 between the sheath 26 and the positioner 20, it does not enter the inner lumen 22 of the positioner 20 or the annular space 24 between the positioner 20 and the inner cannula 16 (as indicated by the X 40).

[0037] FIGS. 5 and 6 show side views of an exemplary delivery device 100 for use with the present invention. As shown in FIG. 5, the delivery device 100 includes a proximal end 102, a distal end 104, a nose cone dilator 106, an atraumatic proximal tip 107 at the end of the nose cone dilator 106, a prosthesis retention region 108, a retractable sheath 110, and sheath hub housing 112. Sheath 110 extends from the proximal end 114 of the sheath hub housing 112. A sheath open distal end 30 (shown in FIG. 1) is disposed within the housing 112 and is in fluid communication with flushing chamber 115. The housing 112 may include a gripping portion 116 to assist in gripping the delivery device 100. As shown, the sheath hub housing 112 has a distal portion 118 which may house a valve (not shown), and a first flushing port 120. A flushing tube 122 may be connected to flushing port 120 to facilitate flushing of the interior of the sheath 110, through the sheath distal end 30 (not shown, but shown in FIG. 1). Distal of the sheath hub housing 112, there may be a deployment assist device 124 having a proximally extending deployment assist sleeve 126, which extends within housing 112 and will be described in further detail below.

[0038] As further shown in FIG. 5, positioner 128 extends at least partially through the delivery device 100. The positioner 128 extends through the delivery device 100 from distal region 130 to just distal of the stent graft retention region 108. The positioner 128 is disposed coaxially over inner cannula 129 (shown in FIG. 6) and partially coaxially within sheath 110. The positioner 128 may partially extend into distal region 130. Sheath 110 is attached to the sheath hub housing 112 for a length from the proximal end 114 of the housing 112 to generally just distal of the nose cone dilator 106 or slightly overlap the distal end of the dilator. As set forth above, the open distal end of the sheath extends into the housing and is in fluid communication with the flushing chamber. The distal region 130 includes handle assembly including, as shown in FIGS. 5 and 6, a first handle 132, and a second handle 134. The first handle 132 may be fixed relative to the delivery device 100. The second handle 134 may be moveable, for example, the second handle may be rotatable. One suitable delivery system is described in US Publication No. 2015/0230955 to Farag Eells, “Deployment handle for a prosthesis delivery device,” the entire contents of which are incorporated by reference herein. At the distal end 136 of second handle 134 is the inner cannula hub 138. Inner cannula hub 138 may comprise a fluid flushing port 140, which may be provided with flushing fluid to flush the lumen of the inner cannula 129 prior to insertion into a patient and to provide other fluids during a prosthesis delivery procedure. Fluid injected through the flush port 140 flushes the inner lumen of the inner cannula and exits out of a hole at the tip 207 of the nose cone. [0039] FIGS. 7 and 8 show partial side views of one example of an endoluminal prosthesis delivery device 200 of the present invention. The delivery device 200 may be the same as or similar to the delivery devices 100 as previously described, but with features of the present invention. As shown, the delivery device 200 includes a distal end 204 (proximal end not shown), a sheath hub 206, a sheath 208 extending from the sheath hub 206, flushing chamber 210 a positioner 212, a first handle 214, a second handle 216, and an inner cannula 218. As shown in FIG. 7, inner cannula 218 runs from the distal end 204 through the delivery device 200 to the nose cone (not shown).

[0040] The positioner 212 is partially coaxially disposed over the inner cannula 218 and defines an annular space 220 (best shown in FIG. 8) between the inner cannula 218 and the positioner 212. The positioner 212 extends from distally of the sheath hub 206, through the sheath hub 206, into the distal open end 207 of the sheath 208 to just distal of or at the distal end (not shown) of the prosthesis retention region (not shown) or somewhat into the lumen of the prosthesis as may be desirable. See FIGS. 1-3 of US Patent No. 11,135,077 for such an arrangement, the disclosure of which is incorporated by reference herein.

[0041] The sheath 208 is shown in FIG. 7 with a portion of the sheath cutaway 222 to show the positioner 212. As shown, a hole 224 in the positioner 212 extends through the wall of the positioner 212 to the inner lumen 228 of the positioner 212, so that the annular space 226 between the positioner 212 and the sheath 208 is in fluid communication with the inner lumen 228 of the positioner 212 and hence, the annular space 226.

[0042] As shown in FIG. 8, the sheath hub 206 has a fluid flush port 230, which may be attached to a flushing tube 232 for the receipt of flushing fluid. Fluid (which may be saline, an inert gas such as CO2, a gas that is soluble in a water-based fluid, such as saline, another flushing media, or a combination thereof in sequential or simultaneous manner), may be injected through the fluid flush port 230 via the tubing 232 into the flushing chamber 210. Flushing fluid as shown by arrows 234 enters the flushing chamber 210, enters the distal open end 207 of the sheath 208 and travels into the annular space 226 between the sheath 208 and the positioner 212. When the fluid reaches hole 224, it enters hole 224 and flows into the annular space 220 between the positioner 212 and the inner cannula 218 and travels the paths shown by the arrows 236) and exits out of the proximal end (not shown) of the positioner 212 and into the stent graft retention region. Hence, fluid introduced into the flushing chamber flushes the annular space 226 between the positioner 212 and the sheath 208, the inner lumen 228 of the positioner, the annular space 220 between the inner cannula 218 and the positioner 212, and the prosthesis retention region (not shown) including the space between the stent graft and the sheath and the inner lumen of the stent graft before exiting out of the proximal end (not shown) of the sheath. Preferably, port 230 is flushed first with a gas that is soluble in a water-based fluid, such as saline, , and then subsequently flushed with saline to dissolve the gas, thereby significantly reducing air in those spaces. Carbon dioxide is considered particularly advantageous for use as the flushing fluid because it provides the desired solubility in the second flushing fluid, saline, and is inert. In addition, the inner cannula may be flushed with either or both the inert gas and saline to flush air from the inner cannula. Without being bound to any theory, the hole in the positioner and the use of carbon dioxide as a flushing fluid work synergistically to surprisingly and unexpectedly significantly reduce air in the system.

[0043] In the embodiment of FIGS. 7-8 (and referring to the delivery device of FIG. 6), the location of the hole is determined by the length of the endoluminal device disposed in the device retention region. The distance from the tip of the device (tip 107 of the dilator/nose cone may be from about 460 mm to about 560 mm (from about 18 inches to about 22 inches). This may place the hole within about 15 mm to about 30 mm from the proximal end 114 of the sheath hub housing 112.

[0044] Referring back to FIGS. 5-6 and applicable to FIGS. 7 and 8, inner cannula hub 138 is in fluid communication with the inner lumen (not shown) of the inner cannula 129 through flushing port 140. Flushing fluid injected into port 140 through hub 138 travels through the inner lumen of the inner cannula 129 and out of the inner cannula 129 through a hole (not shown) at the end of an in the nose cone 106. The hole may be at the proximal tip 107, but it is also contemplated that one or more holes may be placed through the wall of the nose cone through which flushing fluid exits the system.

[0045] FIGS. 9-11 show another embodiment of the novel delivery device, system and method. FIGS. 9 and 11 are partial side views of the delivery device 300. FIG. 10 is a schematic view of this system. In this embodiment, the hole 302 in the positioner 304 is disposed within the sheath hub housing 306 and within flushing chamber 308. Housing 306 may include a valve as is known. Flushing fluid 310 introduced through flushing port 312, via, for example, tubing 314 flows through the hole 302 in the positioner 304 and into the lumen 316 of the positioner 304 and travels proximally through the positioner lumen. In an alternative embodiment, for example if the distal part of the pusher catheter is provided with a hydrophilic element or some other element, the fluid may also flow distally. The fluid also enters the distal end 318 of the sheath 320 disposed with the sheath hub housing 306, thereby flushing both the annular space 322 between the sheath 320 and the positioner 304 (as shown by arrows 330) as well as the lumen 324 of the positioner 304 and the annular space 326 between the positioner 304 and the inner cannula 328 (as shown by arrows 332). Without being bound to any theory, the hole in the positioner and the use of carbon dioxide as a flushing fluid work synergistically to surprisingly and unexpectedly significantly reduce air in the system, as described below.

[0046] As shown schematically in the embodiment of FIG. 10, the second embodiment, the hole 302 is disposed within the housing 306. As shown in FIGS. 7 and 8, the hole 302 is positioned proximally of the housing 306. In both the first and second embodiments, as shown Figures 19 and 20, the positioner 304 may have a bump 305, which provides a mechanical stop, disposed on the positioner 304 just proximal of the hole 302. Bump 305 may be placed from about 2 mm to about 20 mm from the hole 302. Preferably, the length of the bump 305 is between about 6 mm and about 14 mm, preferably from about 8 mm to about 12 mm, and more preferably 10 mm+/-2 mm. The distance between the bump and the hole may be from about 2 mm to about 20 mm, preferably from about 4 mm to about 12 mm, more preferably from about 6 to about 10 mm and most preferably about 8 mm +/- 1 mm. [0047] FIGS. 12-17 are partial views of a positioner 304 with various types and sizes of holes 302. As shown in FIG. 12, the hole 302 is circular. As shown in FIG. 13 the hole is oblong or an oval. In FIG. 14, there are shown multiple oblong holes 302. As with FIG. 14, there may be one or more circular holes in the positioner 304. FIGS. 15 and 16 show a positioner 304 further including a groove 307 along with hole 302. The diameter of the hole 302 may be smaller, the same or larger than the width of the groove. FIG. 17 shows a cross-section of FIG. 16.

[0048] In FIGS. 18-20 (and see FIGS. 5 and 6, elements 124 and 126), the delivery device positioner 400 may include a deployment assist device 402 including assist sleeve 404 and deployment assist device housing 406. Deployment assist valve sleeve 404 extends from the deployment assist device housing 406. The sleeve 404 is disposed over positioner 400 and slidably extends into sheath hub housing 112 (See FIGS. 5 and 6) through a distal aperture (not shown) in housing 112. The sleeve 404 and the housing 406 are moveable between a first position and a second position (as shown in FIGS. 19 and 20). When the sleeve 404 is disposed within the housing 112 it passes through the hemostatic valve assembly (not shown) within housing 112 and assists in the reduction of sheath pullback force. The deployment assist device 402 reduces friction between the valve and the positioner 400 and makes retraction of the sheath smoother and easier. The deployment assist device 402 also makes removal of the delivery device sub-assembly upon completion of the implantation procedure easier. A suitable deployment assist device as described here is disclosed in U.S. Pat. No. 8,419,783, the entire disclosure of which disclosure is incorporated by reference herein.

[0049] FIG. 18 shows the deployment assist device 402 disposed over a positioner 400 of a conventional device. As shown, the deployment assist device 402 has a sleeve 404 and a housing 406. When advanced over the positioner 400, the proximal end 408 of the sleeve 404 will engage with bump/stop 410 preventing further forward movement of the device. As shown in FIG. 18, the bump/stop 410 is well proximal of the sheath hub housing (not shown). FIG. 19 shows a deployment assist device 402 for use with the present invention. As shown, bump or stop 410 is positioned closely adjacent to hole 412 in the positioner 400 and distal of the proximal end of the positioner. Here the bump/stop 410 is placed only slightly proximally of the hole 410, a few millimeters, for example from about 2 mm to about 20 mm and preferably from about 4 mm to about 12 mm (see above). When removing the inner introducer system from the delivery device to use the sheath as a conduit for other devices, the positioner 400 will move distally to cover the hole 412 with the sleeve 404 and the bump/stop 410 will engage the proximal edge 408 of the sleeve 404 as shown in FIG. 20. The repositioned bump/stop 410 of the present invention will assist in avoiding excessive bleeding from the hole 412 in the positioner as the sleeve 404 will cover the hole 412 in the removal process.

[0050] Hole 302 may have a diameter of from about 0.4 mm to about 2.0 mm, and preferably from about 0.5 mm to about to about 1.3 mm depending on the inner diameter (ID) of the sheath. In smaller sheath diameters, for example 16 to 18 Fr., the diameter of the hole may be from about 0.4 mm to about 0.8 mm. In the preferred embodiment, the diameter of the hole is from about 0.5 mm to about 0.7 mm, and in a more preferred embodiment about 0.6 mm in a delivery system where the sheath had an inner diameter of 16/18 Fr.

[0051] In larger sizes, e.g., 20-24 Fr. sheaths, the diameter of the hole 302 may be from about 0.8 mm to about 2.0 mm. Preferably, in these embodiments, the hole has a diameter of from about 1 mm to about 1.5 mm, and more preferably about 1.2 mm in a delivery system where the sheath had an inner diameter of 20 Fr. As demonstrated, by way of example, below, a 0.6 mm hole in the positioner of a 16/18 Fr. sheath delivery system (and combined with a CO2 flushing as described below), significantly and surprisingly reduces the amount of residual air in the delivery system as compared to conventional devices without a hole in the positioner. As also demonstrated below, by way of example, a 1.2 mm hole in the positioner in a 20 Fr. sheath delivery system with a saline flush significantly and surprisingly reduces the amount of residual air in the delivery system as compared to conventional devices without a hole in the positioner. In all embodiments, the hole can be created using conventional techniques. It is preferred, though, to create the hole by punching to avoid burs and other loose material that can be created by other processes, such as drilling. [0052] FIGS 21-26 illustrate results of comparisons of residual air in devices according to embodiments of the invention to residual air in conventional devices.

[0053] The flushing methods used included (1) 3x 20 mL Saline/Heparinized Saline flushed through the Captor valve (sheath hub) of according to current instructions for use of the Cook Medical Zenith Thoracic Alpha (ZTA) proximal component or (2) CO2 at 1,2 bar flushed for 3 min through the Captor valve, and then subsequently flushing 3x 20 mL Saline/Heparinized Saline through the Captor valve.

[0054] FIG. 21 is a graph comparing the residual air in an unmodified commercially available Zenith Thoracic Alpha (ZTA) proximal component in a 20 Fr. delivery system (the largest commercially available ZTA proximal component delivery system) with a modified device according to embodiments of the invention.

[0055] The first column represents the residual air in an unmodified 20 Fr system flushed according to the first method. The second column represents the residual air in an unmodified 20 Fr system flushed according to the second method. The third column represents the residual air in a modified Zenith Thoracic Alpha (ZTA) proximal component in a 20 Fr. delivery system having a 1.2 mm diameter hole in the positioner, according to an embodiment of the invention, and flushed according to the first method. The fourth and final column represents the residual air in a modified Zenith Thoracic Alpha (ZTA) proximal component in a 20 Fr. delivery system having a 1.2 mm diameter hole in the positioner, according to an embodiment of the invention, that was flushed according to the second flushing method. As shown, the unmodified ZTA devices had 0.73 ml and 0.62 residual air when flushed according to the first and second methods, respectively. The modified ZTA devices according to both flushing methods, surprisingly had reduced residual air. As shown, the modified device flushed according to the first flushing method had residual air of 0.46 ml. The modified ZTA device flushed according to the second method had residual air of 0.11 ml, significantly less than the unmodified devices. FIGS. 22 and 23 show the size comparison of the volume of residual air of 0.73 ml (unmodified ZTA device flushed according to the first method) and 0.11 ml (modified ZTA device flushed according to the second method). [0056] FIG. 24 is a graph comparing the residual air in an unmodified commercially available Zenith Thoracic Alpha (ZTA) proximal component in a 16 Fr. delivery system (the smallest commercially available ZTA proximal component delivery system) with a device modified having the signal port with the hole connecting the spaces as discussed above. The first column represents the residual air in a 16 Fr system that was flushed according to the first method. The second column represents the residual air in a 16 Fr system that was flushed according to the second method. The third column represents the residual air in a modified Zenith Thoracic Alpha (ZTA) proximal component in a 16 Fr. delivery system having a 0.6 mm diameter hole in the positioner, according to an embodiment of the invention, that was flushed according to the first method. The fourth and final column represents the residual air in a modified Zenith Thoracic Alpha (ZTA) proximal component in a 16 Fr. delivery system having a 0.6 mm diameter hole in the positioner, according to an embodiment of the invention, that was flushed according to the second method.

[0057] As shown, the unmodified ZTA devices had 0.33 ml and 0.32 residual air when flushed according to the first and second methods, respectively. The modified ZTA device flushed according to the first flushing method had residual air of 0.29 ml. Surprisingly, and unexpectedly, the modified ZTA device with the 0.6 mm hole and flushed according to the second method had residual air of 0.01 ml.

[0058] FIGS. 25 and 26 show the size comparison of the volume of residual air of 0.33 ml (unmodified ZTA device flushed according to the first method) and 0.01 ml (modified ZTA device flushed according to the second method). Given that the 16Fr and 18Fr size have the same internal diameter of the positioner and therefore identical inner lumen, the hole sizes of 0.6 mm are considered to apply to 18Fr system as well.

[0059] Methods of removing residual air from a delivery device for an endoluminal prosthesis are also provided. Descriptions of example methods, and steps of example methods, are provided above in context with description of delivery devices according to example embodiments.

[0060] FIG. 27 illustrates an example method 1000 of removing residual air from a delivery device for an endoluminal prosthesis. An initial step 1010 comprises providing a delivery device according to an embodiment, such as the example delivery devices described above and illustrated in the referenced figures. Another step 1012 comprises injecting a first flushing fluid through the flushing port and into the chamber such that the annular space between the inner cannula and the positioner and the annular space between the positioner and the sheath receive fluid from the chamber from the single flush port and such that the inner lumen of the positioner and the annular space between the positioner and the inner cannula receive flushing fluid from the annular space between the sheath and the positioner by way of the hole in the positioner. Another step 1014 comprises reducing the air in the delivery system. This step 1014 can be the result of performance of step 1012 or step 1016, if included in the method. Alternatively, performance of this step 1014 can include additional physical manipulation of the delivery device to reduce air in the delivery device, such as rotating and tapping a portion of the delivery device with a hand.

[0061] In some example methods, the first flushing fluid is gas that is soluble in a water-based solution, such as saline. Carbon dioxide is considered particularly advantageous for use as the flushing fluid because it provides the desired solubility and is inert. Also, in some example methods, an additional step 1016 of injecting a second flushing fluid is included, and can be performed concurrently or sequentially with the step 1012 of injecting a first flushing fluid and before the step 1014 of reducing air in the delivery system. Also, in these example methods, the first and second flushing fluids can be the same or different. In preferred methods, the first and second flushing fluids are different. In more preferred example methods, the first flushing fluid is a gas that is soluble in the second flushing fluid, which is a liquid. In more preferred example methods, the first flushing fluid is an inert gas and the second flushing fluid is a liquid, such as saline. In more preferred example methods, the first flushing fluid is an inert gas, such as carbon dioxide and the second flushing fluid is a liquid, such as saline. In more preferred example methods, the first flushing fluid is carbon dioxide and the second flushing fluid is saline. In more preferred example methods, the first flushing fluid is carbon dioxide and the second flushing fluid is saline, and the step 1016 of injecting a second flushing fluid is initiated after completing the step 1012 of injecting a first flushing fluid. [0062] FIG. 28 illustrates another example method 2000 of removing residual air from a delivery device for an endoluminal prosthesis. An initial step 2010 comprises injecting a first flushing fluid through the flushing port of a delivery device according to an embodiment. This step 2010 is performed until the first flushing fluid enters the chamber such that the annular space between the inner cannula and the positioner of the delivery device and the annular space between the positioner and the sheath of the delivery device receive the first flushing fluid from the chamber from the single flushing port and such that the inner lumen of the positioner and the annular space between the positioner and the inner cannula of the delivery device receive the first flushing fluid from the annular space between the sheath and the positioner of the delivery device by way of the hole in the positioner.

[0063] Another step 2012 comprises injecting a second flushing fluid through the flushing port of the delivery device. This step 2012 is performed until the second flushing fluid enters the chamber such that the annular space between the inner cannula and the positioner of the delivery device and the annular space between the positioner and the sheath of the delivery device receive the second flushing fluid from the chamber from the single flushing port and such that the inner lumen of the positioner and the annular space between the positioner and the inner cannula of the delivery device receive the second flushing fluid from the annular space between the sheath and the positioner of the delivery device by way of the hole in the positioner. This step 2012 can be performed concurrently with performance of step 2010. Advantageously, though, performance of this step 2012 is initiated after step 2010 has been completed.

[0064] Another step 2014 comprises reducing the air in the delivery system. This step 2014 can be the result of performance of step 2012. Alternatively, performance of this step 2014 can include additional physical manipulation of the delivery device to reduce air in the delivery device, such as rotating and tapping a portion of the delivery device with a hand.

[0065] Also, in method 2000, the first and second flushing fluids can be the same or different. In preferred methods, the first and second flushing fluids are different. In more preferred example methods, the first flushing fluid is a gas and the second flushing fluid is a liquid. In more preferred example methods, the first flushing fluid is a gas that is soluble in the second flushing fluid, which is a liquid, such as saline. In more preferred example methods, the first flushing fluid is an inert gas, such as carbon dioxide, and the second flushing fluid is a liquid, such as saline. In more preferred example methods, the first flushing fluid is carbon dioxide and the second flushing fluid is saline. In more preferred example methods, the first flushing fluid is carbon dioxide and the second flushing fluid is saline, and the step 2012 of injecting a second flushing fluid is initiated after completing the step 2010 of injecting a first flushing fluid.

[0066] All optional and preferred features and modifications of the described embodiments and dependent claims are usable in all aspects of the invention taught herein. Furthermore, the individual features of the dependent claims, as well as all optional and preferred features and modifications of the described embodiments, are combinable and interchangeable with one another.

Claims

CLAIMS [0067] What is claimed is:

1. A delivery device for delivering an endoluminal prosthesis to patient, comprising: a proximal end; a distal end; an inner cannula extending through the delivery device and having a proximal end, a distal end, and an inner lumen there between, the inner lumen configured to receive at least one wire guide; a prosthesis retention region in a proximal region of the delivery device; a positioner catheter disposed at least partially coaxially over the inner cannula and having an inner lumen, a sidewall and a hole disposed within the side wall; a sheath hub having an inner chamber configured to receive flushing fluid from a single flush port in fluid communication with the inner chamber; a sheath disposed at least partially coaxially over the positioner, the inner cannula, and the prothesis retention region and extending from a proximal end of the sheath hub, the sheath having an open distal end in fluid communication with the inner chamber; an annular space between the inner cannula and the positioner in fluid communication with the inner chamber and the hole; an annular space between the positioner and the sheath in fluid communication with the inner chamber and the hole; wherein the annular space between the inner cannula and the positioner and the annular space between the positioner and the sheath are both configured to receive fluid from the chamber from the single flush port; wherein the inner lumen of the positioner and the annular space between the positioner and the inner cannula are configured to receive flushing fluid from the annular space between the sheath and the positioner by way of the hole in the positioner; and wherein subsequent to injection of the flushing fluid, air in the delivery device is reduced.

2. The delivery device of claim 1, wherein the hole in the positioner is disposed in the chamber.

3. The delivery device of claim 1, wherein the hole is disposed in the positioner proximally of the sheath hub.

4. The delivery device of claim 1 , wherein the flushing fluid comprises saline.

5. The delivery device of claim 1, wherein the flushing fluid comprises an inert gas.

6. The delivery device of claim 5, wherein the inert gas is carbon dioxide.

7. The delivery device of claim 1, wherein the injection of the flushing fluid comprises a first injection of a gas that is soluble in a second flushing fluid and a subsequent injection of the second flushing fluid.

8. The delivery device of claim 7, wherein the gas is carbon dioxide and the second flushing fluid is saline.

9. The delivery device of claim 1, wherein prior to insertion into a patient the device has a first volume of residual air and after injection of the flushing fluid has a second volume of residual air less than the first.

10. A delivery device for delivering an endoluminal prosthesis to patient, comprising: a proximal end; a distal end; an inner cannula extending through the delivery device and having a proximal end, a distal end, and an inner lumen there between, the inner lumen configured to receive at least one wire guide; a prosthesis retention region in a proximal region of the delivery device; a positioner catheter disposed at least partially coaxially over the inner cannula and having an inner lumen, a sidewall and a hole disposed within the side wall; a sheath hub having an inner chamber configured to receive fluid from a single port in fluid communication with the inner chamber; a sheath disposed at least partially coaxially over the positioner, the inner cannula, and the prothesis retention region and extending from a proximal end of the sheath hub, the sheath having an open distal end in fluid communication with the inner chamber; an annular space between the inner cannula and the positioner in fluid communication with the inner chamber and the hole; and an annular space between the positioner and the sheath in fluid communication with the inner chamber and the hole; wherein the hole in the positioner is disposed proximally of the sheath hub; wherein the annular space between the inner cannula and the positioner and the annular space between the positioner and the sheath are both configured to receive fluid from the chamber from the single flush port; wherein the inner lumen of the positioner and the annular space between the positioner and the inner cannula are configured to receive flushing fluid from the annular space between the sheath and the positioner by way of the hole in the positioner; and wherein subsequent to injection of the flushing fluid, air in the delivery device is reduced.

11. The delivery device of claim 10, wherein the flushing fluid comprises saline.

12. The delivery device of claim 10, wherein the flushing fluid comprises an inert gas.

13. The delivery device of claim 12, wherein the inert gas is carbon dioxide.

14. The delivery device of claim 10, wherein the injection of the flushing fluid comprises a first injection of a gas that is soluble in a second flushing fluid and a subsequent injection of the second flushing fluid.

15. The delivery device of claim 13, wherein the gas is carbon dioxide and the second flushing fluid is saline.

16. The delivery device of claim 10, wherein prior to insertion into a patient the device has a first volume of air and after injection of the flushing fluid has a volume of residual air less than the first.

17. A method of removing residual air from a delivery device for an endoluminal prosthesis, comprising: providing a delivering device comprising: an inner cannula extending through the delivery device and having a proximal end, a distal end, and an inner lumen there between, the inner lumen configured to receive at least one wire guide; a prosthesis retention region in a proximal region of the delivery device; a positioner catheter disposed at least partially coaxially over the inner cannula and having an inner lumen, a sidewall and a hole disposed within the side wall; a sheath hub having an inner chamber configured to receive flushing fluid from a single flushing port in fluid communication with the inner chamber; a sheath disposed at least partially coaxially over the positioner, the inner cannula, and the prothesis retention region and extending from a proximal end of the sheath hub, the sheath having an open distal end in fluid communication with the inner chamber; an annular space between the inner cannula and the positioner in fluid communication with the inner chamber and the hole; and an annular space between the positioner and the sheath in fluid communication with the inner chamber and the hole; and injecting a first flushing fluid through the flushing port and into the chamber; wherein the annular space between the inner cannula and the positioner and the annular space between the positioner and the sheath receive fluid from the chamber from the single flush port; wherein the inner lumen of the positioner and the annular space between the positioner and the inner cannula receive flushing fluid from the annular space between the sheath and the positioner by way of the hole in the positioner; and reducing the air in the delivery system.

18. The method of claim 17, wherein the step of injecting flushing fluid comprises injecting a first flushing fluid comprising a gas that is soluble in a second flushing fluid.

19. The method of claim 18, wherein the gas is carbon dioxide.

20. The method of claim 19, wherein the second flushing fluid is saline.