WO2025196742A2 - Dispositifs, procédés et systèmes de réduction de l'air dans une mise en place - Google Patents

Dispositifs, procédés et systèmes de réduction de l'air dans une mise en place

Info

Publication number
WO2025196742A2
WO2025196742A2 PCT/IB2025/055318 IB2025055318W WO2025196742A2 WO 2025196742 A2 WO2025196742 A2 WO 2025196742A2 IB 2025055318 W IB2025055318 W IB 2025055318W WO 2025196742 A2 WO2025196742 A2 WO 2025196742A2
Authority
WO
WIPO (PCT)
Prior art keywords
positioner
sheath
delivery device
annular space
fluid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/IB2025/055318
Other languages
English (en)
Other versions
WO2025196742A3 (fr
Inventor
John Mogensen
Simon Voigt Andersen
Erik E. Rasmussen
Adria Rodriguez Paz
Bent øHLENSCHLAEGER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cook Medical Technologies LLC
Original Assignee
Cook Medical Technologies LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cook Medical Technologies LLC filed Critical Cook Medical Technologies LLC
Publication of WO2025196742A2 publication Critical patent/WO2025196742A2/fr
Publication of WO2025196742A3 publication Critical patent/WO2025196742A3/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0004—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0019—Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable

Definitions

  • 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.
  • Endovascular methods have been proposed for treatment of diseases of the aorta such as aortic dissections, aortic aneurysms, defective heart valves and the like.
  • prostheses such as stent grafts
  • 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.
  • 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.
  • 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.
  • the blood/gas interface can cause coagulation, inflammation and vasogenic edema which can subsequently lead to cytotoxic brain edema.
  • 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.
  • 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 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.
  • 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.
  • a delivery device for delivering an endoluminal prosthesis to patient having reduced residual air 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.
  • a method of removing residual air from a delivery device for an endoluminal prosthesis 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.
  • FIG. 1 shows a cross-section of a conventional system and the direction of flow of flushing fluid from a flushing entry port
  • 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;
  • FIG. 18 is a partial side view of a positioner/pusher catheter with a deployment assist device.
  • 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.
  • FIG. 21 is a chart comparing residual air in devices with and without various aspects of the present invention.
  • FIGS. 22-23 show representations of the volume of residual air from the chart of FIG. 21.
  • FIG. 24 is a chart comparing residual air in devices with and without various aspects of the present invention.
  • FIGS. 25-26 is a chart comparing residual air in devices with and without various aspects of the present invention.
  • FIG. 27 is a flowchart illustration of an example method of removing residual air from a delivery device for an endoluminal prosthesis.
  • FIG. 28 is a flowchart illustration of another example method of removing residual air from a delivery device for an endoluminal prosthesis.
  • 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.
  • the inner catheter also referred to as the positioner or pusher catheter
  • 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.
  • a flushing fluid such as saline
  • inert high blood soluble gas such as carbon dioxide
  • a port in fluid communication with the inner cannula may be used to flush the inner cannula lumen.
  • 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.
  • 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.
  • 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.
  • 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.
  • “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.
  • FIG. 1 shows a partial cross-section of a conventional system and the direction of flow of flushing fluid from the flushing entry port.
  • 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.
  • inner cannula 16 also called a guide wire/wire guide catheter
  • 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.
  • 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.
  • 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.
  • the prothesis for example, a stent graft, stent or heart valve replacement
  • 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).
  • FIGS. 5 and 6 show side views of an exemplary delivery device 100 for use with the present invention.
  • 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.
  • 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.
  • 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.
  • 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.
  • the inner cannula hub 138 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.
  • 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.
  • 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.
  • inner cannula 218 runs from the distal end 204 through the delivery device 200 to the nose cone (not shown).
  • 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.
  • 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.
  • 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
  • Fluid 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.
  • 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.
  • 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.
  • the inner cannula may be flushed with either or both the inert gas and saline to flush air from the inner cannula.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • FIGS. 12-17 are partial views of a positioner 304 with various types and sizes of holes 302.
  • the hole 302 is circular.
  • the hole is oblong or an oval.
  • FIG. 14 there are shown multiple oblong holes 302.
  • 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.
  • 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).
  • the sleeve 404 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.
  • FIG. 18 shows the deployment assist device 402 disposed over a positioner 400 of a conventional device.
  • the deployment assist device 402 has a sleeve 404 and a housing 406.
  • the proximal end 408 of the sleeve 404 will engage with bump/stop 410 preventing further forward movement of the device.
  • 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.
  • 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).
  • 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.
  • 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.
  • ID inner diameter
  • the diameter of the hole may be from about 0.4 mm to about 0.8 mm.
  • 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.
  • the diameter of the hole 302 may be from about 0.8 mm to about 2.0 mm.
  • 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.
  • a 0.6 mm hole in the positioner of a 16/18 Fr. sheath delivery system significantly and surprisingly reduces the amount of residual air in the delivery system as compared to conventional devices without a hole in the positioner.
  • FIGS 21-26 illustrate results of comparisons of residual air in devices according to embodiments of the invention to residual air in conventional devices.
  • 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.
  • ZTA Cook Medical Zenith Thoracic Alpha
  • 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.
  • ZTA Zenith Thoracic Alpha
  • 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.
  • 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.
  • 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.
  • ZTA 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.
  • 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.
  • ZTA Zenith Thoracic Alpha
  • 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.
  • the modified ZTA device with the 0.6 mm hole and flushed according to the second method had residual air of 0.01 ml.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the first and second flushing fluids can be the same or different. In preferred methods, the first and second flushing fluids are different.
  • the first flushing fluid is a gas that is soluble in the second flushing fluid, which is a liquid.
  • the first flushing fluid is an inert gas and the second flushing fluid is a liquid, such as saline.
  • the first flushing fluid is an inert gas, such as carbon dioxide and the second flushing fluid is a liquid, such as saline.
  • the first flushing fluid is carbon dioxide and the second flushing fluid is saline.
  • 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.
  • 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.
  • 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.
  • performance of this step 2012 is initiated after step 2010 has been completed.
  • the first and second flushing fluids can be the same or different.
  • the first and second flushing fluids are different.
  • the first flushing fluid is a gas and the second flushing fluid is a liquid.
  • the first flushing fluid is a gas that is soluble in the second flushing fluid, which is a liquid, such as saline.
  • the first flushing fluid is an inert gas, such as carbon dioxide
  • the second flushing fluid is a liquid, such as saline.
  • the first flushing fluid is carbon dioxide and the second flushing fluid is saline.
  • 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.

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  • Health & Medical Sciences (AREA)
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  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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Abstract

[0068] La présente invention porte sur un système de dispositif de mise en place et un procédé de mise en place d'une prothèse endoluminale dans un patient. Le dispositif de mise en place comporte une canule interne; une région de retenue de prothèse dans une région proximale du dispositif de mise en place; un cathéter de positionnement disposé au moins partiellement coaxialement sur la canule interne et ayant une lumière interne, une paroi latérale et un trou disposé à l'intérieur de la paroi latérale; un moyeu de gaine ayant une chambre interne configurée pour recevoir un fluide de rinçage provenant d'un orifice de rinçage en communication fluidique avec la chambre interne; une gaine disposée au moins partiellement coaxialement sur le positionneur, la canule interne et la région de rétention de prothèse et s'étendant à partir d'une extrémité proximale du moyeu de gaine, la gaine ayant une extrémité distale ouverte en communication fluidique avec la chambre interne; un espace annulaire entre la canule interne et le positionneur en communication fluidique avec la chambre interne et le trou; et un espace annulaire entre le positionneur et la gaine en communication fluidique avec la chambre interne et le trou. Lors de l'injection d'un fluide de rinçage dans la chambre interne, un espace annulaire entre le positionneur et la gaine est configuré pour recevoir un fluide provenant de la chambre et l'espace annulaire entre la canule interne et le positionneur et la lumière du positionneur sont configurés pour recevoir un fluide provenant de la chambre à travers le trou, moyennant quoi l'air résiduel dans le système est réduit L'invention concerne également un procédé de réduction de l'air dans le système de mise en place.
PCT/IB2025/055318 2024-03-22 2025-05-22 Dispositifs, procédés et systèmes de réduction de l'air dans une mise en place Pending WO2025196742A2 (fr)

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Citations (4)

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US8419783B2 (en) 2010-07-07 2013-04-16 Cook Medical Technologies Llc Graft deployment assist tool
US20150230955A1 (en) 2014-02-16 2015-08-20 Cook Medical Technologies Llc Deployment handle for a prosthesis delivery device
US11135077B2 (en) 2016-12-16 2021-10-05 Cook Medical Technologies Llc Method of air reduction in stent graft delivery device
US11311396B2 (en) 2015-08-11 2022-04-26 Mokita Medical Gmbh Systems and methods for removing air from medical devices

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US6375676B1 (en) * 1999-05-17 2002-04-23 Advanced Cardiovascular Systems, Inc. Self-expanding stent with enhanced delivery precision and stent delivery system
US7955370B2 (en) * 2004-08-06 2011-06-07 Boston Scientific Scimed, Inc. Stent delivery system
US9498364B2 (en) * 2013-03-29 2016-11-22 Cook Medical Technologies Llc Medical device delivery system and method of flushing same
WO2018026818A1 (fr) * 2016-08-02 2018-02-08 Boston Scientific Scimed, Inc. Système de pose d'endoprothèse
US20200261250A1 (en) * 2019-02-18 2020-08-20 Cook Medical Technologies Llc Stent delivery system with combined flushing port

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8419783B2 (en) 2010-07-07 2013-04-16 Cook Medical Technologies Llc Graft deployment assist tool
US20150230955A1 (en) 2014-02-16 2015-08-20 Cook Medical Technologies Llc Deployment handle for a prosthesis delivery device
US11311396B2 (en) 2015-08-11 2022-04-26 Mokita Medical Gmbh Systems and methods for removing air from medical devices
US11135077B2 (en) 2016-12-16 2021-10-05 Cook Medical Technologies Llc Method of air reduction in stent graft delivery device

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