Patent Application
20150250481
The present invention is related to an endovascular delivery system for an endovascular prosthesis. More particularly, the present invention is related to an endovascular delivery system having an inflatable occlusion wire-balloon for aortic applications where rupture of an aneurysm may be a concern for a patient's health.
An aneurysm is a medical condition indicated generally by an expansion and weakening of the wall of an artery of a patient. Aneurysms can develop at various sites within a patient's body. Thoracic aortic aneurysms (TAAs) or abdominal aortic aneurysms (AAAs) are manifested by an expansion and weakening of the aorta which is a serious and life threatening condition for which intervention is generally indicated. Existing methods of treating aneurysms include invasive surgical procedures with graft replacement of the affected vessel or body lumen or reinforcement of the vessel with a graft.
Surgical procedures to treat aortic aneurysms can have relatively high morbidity and mortality rates due to the risk factors inherent to surgical repair of this disease as well as long hospital stays and painful recoveries. This is especially true for surgical repair of TAAs, which is generally regarded as involving higher risk and more difficulty when compared to surgical repair of AAAs. An example of a surgical procedure involving repair of a AAA is described in a book titled Surgical Treatment of Aortic Aneurysms by Denton A. Cooley, M.D., published in 1986 by W.B. Saunders Company.
Due to the inherent risks and complexities of surgical repair of aortic aneurysms, endovascular repair has become a widely-used alternative therapy, most notably in treating AAAs. Early work in this field is exemplified by Lawrence, Jr. et al. in “Percutaneous Endovascular Graft Experimental Evaluation”, Radiology (May 1987) and by Mirich et al. in “Percutaneously Placed Endovascular Grafts for Aortic Aneurysms: Feasibility Study,” Radiology (March 1989). Commercially available endoprostheses for the endovascular treatment of AAAs include the Endurant™ and Talent™ Abdominal Stent Grafts sold by Medtronic, Inc. of Minneapolis, Minn.; the Zenith Flex® AAA Endovascular Graft and the Zenith TX2® TAA Endovascular Graft, both sold by Cook Medical, Inc. of Bloomington, Ind.; the AFX™ Endovascular AAA system sold by Endologix, Inc. of Irvine, Calif.; and the Gore® Excluder® AAA Endoprosthesis sold by W.L. Gore & Associates, Inc. of Flagstaff, Ariz. A commercially available stent graft for the treatment of TAAs is the Gore® TAG® Thoracic Endoprosthesis sold by W.L. Gore & Associates, Inc. of Flagstaff, Ariz.
It is believed that not an insignificant number of aortic aneurysms, such as up to about seven percent, may involve priority medical procedures, such as endovascular repair (EVAR). Such priority medical procedures are concerned with potential rupture of an aneurysm. Use of occlusion balloons to avoid blood loss in patients with potential rupture of aneurysms has been proposed. See for example, Philipsen, Tine E. et al, “The Use of Rapid Endovascular Balloon Occlusion in Unstable Patients With Ruptured Abdominal Aortic Aneurysm”, Innovations, Volume 4, Number 2, March/April 2009, pages 74-79; Mehta, Manish, “Compliant Occlusion Balloons—Use of Compliant Occlusion Balloons During EVAR for AAA Rupture”, Insert to Endovascular Today, November 2008, pages 29-31. Such proposed uses involve separate occlusion balloon catheters and separate EVAR delivery device catheters. What have been needed are stent graft systems, delivery systems and methods that are adaptable to a wide range of patient anatomies and that can be safely and reliably deployed using a flexible low profile system having integrated occlusion balloon capability.
In one aspect of the present invention an endovascular delivery system is provided. The endovascular delivery system may comprise: a prosthesis comprising a main tubular body having an open proximal end and opposed open ipsilateral and contralateral legs; an elongate outer tubular sheath having an open lumen and opposed proximal and distal ends with a medial portion therein between; an elongate inner tubular member slidably disposed within the open lumen of the outer tubular sheath; wherein the distal end of the outer tubular sheath being slidably disposed past and beyond the distal end of the inner tubular member to define a prosthesis delivery state and slidably retractable to the medial portion of the inner tubular member to define a prosthesis unsheathed state; an elongate guidewire slidably disposed within the inner tubular member and extending from the handle assembly, through the ipsilateral leg of the prosthesis and through the main tubular body of the prosthesis and extending past the open of the main tubular body in the prosthesis delivery state, said elongate guidewire comprising a hollow portion such that the inflatable occlusion balloon is in fluid communication with a balloon inflation material; and an inflatable occlusion balloon disposed on a portion of the elongate guidewire extending past the open end of the main tubular body. The main tubular body may comprise an inflatable cuff disposed near the open proximal end.
The elongate guidewire may comprise a hollow portion such that the inflatable occlusion balloon is in fluid communication with a balloon inflation material. Further, the portion of the elongate guidewire over which the occlusion balloon is disposed may haves porosity, such as a hole or a plurality of holes, for ingress and egress of the balloon inflation material. Moreover, the balloon inflation material may comprise saline and contrast material.
The elongate guidewire may comprise a metallic material, a polymeric material or a combination thereof.
The endovascular delivery system may further comprise a removable mandrel disposed at least partially within hollow portion of the elongate guidewire for supporting elongate guidewire prior to inflation of the occlusion balloon. Moreover, the endovascular delivery system may further comprise a seal disposed on a portion of the elongate guidewire disposed within the handle assembly.
The endovascular delivery system may further comprise a first radiopaque marker disposed on a portion of the elongate guidewire just past the occlusion balloon and/or a second radiopaque marker disposed on a portion of the elongate guidewire just prior the occlusion balloon.
In another aspect of the present invention, an endovascular delivery system may comprise a prosthesis comprising a main tubular body having an open end and opposed open end; an elongate outer tubular sheath having an open lumen and opposed proximal and distal ends with a medial portion therein between; an elongate guidewire slidably disposed within the inner tubular member and extending from the handle assembly, through the ipsilateral leg of the prosthesis and through the main tubular body of the prosthesis and extending past the open of the main tubular body in the prosthesis delivery state, said elongate guidewire comprising a hollow portion such that the inflatable occlusion balloon is in fluid communication with a balloon inflation material; an elongate guidewire slidably disposed within the inner tubular member and extending from the handle assembly through the main tubular body of the prosthesis and extending past the open of the main tubular body in the prosthesis delivery state; and an inflatable occlusion balloon disposed on a portion of the elongate guidewire extending past the open end of the main tubular body.
In another aspect of the present invention, a method for delivering a bifurcated prosthesis may comprise providing the endovascular delivery system of the present invention; advancing the endovascular delivery system through a first branched artery and into an aneurysm in a main artery; retracting the outer sheath so that the proximal end of the main tubular body of the prosthesis is disposed beyond the aneurysm and so that the ipsilateral and contralateral legs are disposed within the aneurysm; inflating the occlusion balloon with an inflation material in the main artery beyond the aneurysm to provide a seal against blood flow thereat; deploying the prosthesis; inflating the inflatable cuff of the main tubular body to provide a seal against blood in the main artery beyond the aneurysm; and deflating the occlusion balloon.
The method may further comprise: deploying a contralateral graft extension having opposed proximal and distal open ends contained within a catheter so that the proximal end of the contralateral graft extension is disposed within a portion of the contralateral leg of the main tubular body of the prosthesis and so that the distal end of the contralateral graft extension is disposed distally of the aneurysm and within a portion of a second branched artery. Moreover, the method may further comprise: deploying a ipsilateral graft extension having opposed proximal and distal open ends contained within a second catheter so that the proximal end of the ipsilateral graft extension is disposed within a portion of the ipsilateral leg of the main tubular body of the prosthesis and so that the distal end of the ipsilateral graft extension is disposed distally of the aneurysm and within a portion of the first branched artery.
In another aspect of the present invention, an assembly for rapid endovascular balloon occlusion may comprise: a guidewire having a hollow lumen portion, a proximal portion, a distal portion and a balloon mounting portion therein between; a non-compliant or semi-compliant occlusion balloon securably disposed on the balloon mounting portion of the guidewire and in fluid communication with the hollow lumen portion; and a catheter having a sheath having the non-compliant or semi-compliant balloon and portions of the guidewire slidably disposed therein. The assembly may further comprise: a syringe having inflation material for inflating the non-compliant or semi-compliant balloon; and a luer fitting for providing fluid communication of the inflation material to the hollow lumen portion of the guidewire. Further, the guidewire may have an outer diameter of about 0.035 inches (0.9 mm) and a hollow lumen diameter of about 0.015 inches (0.38 mm) to about 0.030 inches (0.76 mm).
In another aspect of the present invention, a method for rapid endovascular balloon occlusion may comprise: providing a guidewire having a hollow lumen portion, a proximal portion, a distal portion and a balloon mounting portion therein between; providing a non-compliant or semi-compliant occlusion balloon securably disposed on the balloon mounting portion of the guidewire and in fluid communication with the hollow lumen portion; providing a catheter having a sheath having the non-compliant or semi-compliant balloon and portions of the thin guidewire slidably disposed therein; providing a syringe having inflation material for inflating the non-compliant or semi-compliant balloon; and a luer fitting for providing fluid communication of the inflation material to the hollow lumen portion of the guidewire; delivering the catheter to a desired bodily location; withdrawing the sheath of the catheter to expose the occlusion balloon; and inflating the occlusion balloon with the inflation material. The occlusion balloon may be inflated with the inflation material within about 15 to about 30 seconds. The guidewire may have an outer diameter of about 0.035 inches (0.9 mm) and a hollow lumen diameter of about 0.015 inches (0.38 mm) to about 0.030 inches (0.76 mm).
These and other features and advantages of the present invention will become apparent from the following detailed description of illustrative embodiments thereof, which is to be read in connection with the accompanying drawings. Corresponding reference element numbers or characters indicate corresponding parts throughout the several views of the drawings.
Embodiments of the invention are directed generally to methods and devices for treatment of fluid flow vessels with the body of a patient, including EVAR methods and devices. Treatment of blood vessels is specifically indicated for some embodiments, and, more specifically, treatment of aneurysms, such as abdominal aortic aneurysms. With regard to endovascular prosthesis or stent/stent-graft embodiments discussed herein and components or portions thereof, the term “proximal” refers to a location towards a patient's heart and the term “distal” refers to a location away from the patient's heart. With regard to delivery system catheters and components thereof discussed herein, the term “distal” refers to a location that is disposed away from an operator who is using the catheter and the term “proximal” refers to a location towards the operator.
While an embodiment of the present invention is described hereinafter in relation to a particular inflatable stent-graft, the present invention may be used with any suitable endovascular prosthesis for use within a patient's vasculature, including branched and non-branched bodily lumens. The endovascular prosthesis may have inflatable cuffs and/or channels for sealing against vessel walls, such as non-aneurysmal vessel walls. Alternatively or in addition to, the endovascular prosthesis may include inflatable components to seal or strengthen aneurysmal walls or to occupy aneurysmal sac areas. Use of a non-inflatable endovascular prosthesis, either alone or in combination with other inflatable or non-inflatable endovascular prostheses may be suitably used with the embodiments of the present invention. Further, suitable endovascular prostheses may include, but are not limited to, stent-grafts, grafts without stents; grafts with anchoring, typically expandable members either directly associated with the grafts or indirectly associated with grafts through the use of connecting members, such as struts, tethers, sutures and the like. Further, useful endovascular prostheses include modular prostheses and uni-body prostheses. Thus, the embodiments of the delivery system according to the present invention may be used with a variety of endovascular prostheses.
Further, while embodiments of the present invention are described for use in the treatment of abdominal aortic aneurysms (AAAs), the present invention is not so limited. For example, embodiments of the present invention may be used in the treatment of thoracic aortic aneurysms (TAAs), other aortic aneurysms, arteriovenous aneurysms, artherosclerotic aneurysms, compound aneurysms, dissecting aneurysms, fusiform aneurysms, mycotic aneurysms, sacculated aneurysms and the like. Further, embodiments of the present invention may be used in the treatment of bodily lumens at, near or remote from branched lumens.
The endovascular delivery system 100 may be advanced into the aorta 10 of the patient until the endovascular prosthesis (not shown) is disposed substantially adjacent an aortic aneurysm 20 or other vascular defect to be treated. The portion of the endovascular delivery system 100 that is advanced through bodily lumens is in some embodiments a low profile delivery system; for example, having an overall outer diameter of less than 14 French. Other diameters are also useful, such as but not limited to less than 12 French, less than 10 French, or any sizes from 10 to 14 French or greater. The diameter (D) of a round catheter in millimeters can be determined by dividing the French (Fr) size by 3, i.e., D (mm)=Fr/3. Once the endovascular delivery system 100 is so positioned, an outer sheath 104 of the endovascular delivery system 100 may be retracted distally so as to expose the prosthesis (not shown) which has been compressed and compacted to fit within the inner lumen of the outer sheath 104 of the endovascular delivery system 100. The present invention, however, is not limited to delivery systems requiring the retraction of an outer sheath for exposing a prosthesis and other techniques may suitably be used, such as, but not limited to, splitable sheaths, compressing coils, sutures or threads, and the like.
As depicted in
In addition to being radially compressed when disposed within an inner lumen of the outer sheath 104 of the endovascular delivery system 100, embodiments of endovascular prostheses useful with the present invention may include a proximal stent 108 that may be radially restrained by high strength flexible belts 110 in order to maintain a small profile and avoid engagement of the proximal stent 108 with a body lumen wall until deployment of the proximal stent 108 is initiated. The use of such belts 110 is for illustrative purposes only and other suitable restraining members may suitable be used. The belts 110 can be made from any high strength, resilient material that can accommodate the tensile requirements of the belt members and remain flexible after being set in a constraining configuration. Typically, belts 110 are made from solid ribbon or wire of a shape memory alloy such as nickel titanium or the like, although other metallic or polymeric materials are possible. Belts 110 may also be made of braided metal filaments or braided or solid filaments of high strength synthetic fibers such as Dacron®, Spectra or the like. An outside transverse cross section of the belts 110 may range from about 0.002 inches (0.05 mm) to about 0.012 inches (0.30 mm), specifically, about 0.004 inches (0.10 mm) to about 0.007 inches (0.18 mm). The cross sections of belts 110 may generally take on any shape, including rectangular (in the case of a ribbon), circular, elliptical, square, etc. The ends of the belts 110 may be secured by one or more stent release wires or elongate rods 112 which extend through looped ends (not shown) of the belts 110. The stent release wires or elongate rods 112 may be disposed generally within the prosthesis 106 during delivery of the system 100 to the desired bodily location. For example, the stent release wires or elongate rods 112 may enter and exit the guidewire lumen 122 or other delivery system lumen as desired to affect controlled release of the stent 108, including if desired controlled and staged release of the stent 108. Once the outer sheath 104 of the endovascular delivery system 100 has been retracted, the endovascular delivery system 100 and the endovascular prosthesis 106 may be carefully positioned in an axial direction such that the proximal stent 108 is disposed substantially even with the renal arteries. Further details, including but not limited to methods, catheters and systems, for deployment of endovascular prostheses are disclosed in commonly owned U.S. Pat. Nos. 6,761,733 and 6,733,521 and commonly owned U.S. Patent Application Publication Nos. 2006/0009833 and 2009/0099649, all of which are incorporated by reference herein in their entirety.
In some embodiments, the endovascular prosthesis 106 may include inflatable or non-inflatable unibody and/or bifurcated grafts, such as an inflatable bifurcated graft 114. The inflatable graft may be, for example, a bifurcated graft having a main graft body 124 (that may also be referred to as an “aortic body”), an ipsilateral graft leg 126 and a contralateral graft leg 128. The inflatable graft 114 may further include a fill port 116 in fluid communication with an inflation tube 118 of the endovascular delivery system 100 for providing an inflation medium (not shown). Examples of useful inflation medium may be found in U.S. Pat. No. 8,535,705 and commonly owned U.S. Patent Application Publication Nos. 2011/0196060 and 2005/0158272, the contents of all of which are incorporated in their entirety herein by reference. The distal portion of the endovascular delivery system 100 may optionally include a nosecone 120 which provides an atraumatic distal portion of the endovascular delivery system 100. The guidewire 102 is slidably disposed within a guidewire lumen 122 of the endovascular delivery system 100.
The guidewire 102 may include an occlusion balloon 200, which is depicted in its uninflated state or delivery state. As depicted in
As depicted in
As depicted in
Once the proximal stent 108 has been partially or fully deployed, the proximal inflatable cuff 134 of inflatable versions of prostheses that may be used in the present invention may then be filled through the inflation port 116 with inflation material injected through an inflation tube 118 of the endovascular delivery system 100 which may serve to seal an outside surface of the inflatable cuff 134 to the inside surface of the vessel 10. The remaining network of inflatable channels 136 may also be filled with pressurized inflation material at the same time which provides a more rigid frame like structure to the inflatable graft 114. For some embodiments, the inflation material may be a biocompatible, curable or hardenable material that may cured or hardened once the network of inflatable channels 136 are filled to a desired level of material or pressure within the network or after passage of a predetermined period of time. Some embodiments may also employ radiopaque inflation material to facilitate monitoring of the fill process and subsequent engagement of graft extensions (not shown). The material may be cured by any of the suitable methods discussed herein including time lapse, heat application, application of electromagnetic energy, ultrasonic energy application, chemical adding or mixing or the like. Some embodiments for the inflation material that may be used to provide outward pressure or a rigid structure from within the inflatable cuff 134 or network of inflatable channels 136 may include inflation materials formed from glycidyl ether and amine materials. Some inflation material embodiments may include an in situ formed hydrogel polymer having a first amount of diamine and a second amount of polyglycidyl ether wherein each of the amounts are present in a mammal or in a medical device, such as an inflatable graft, located in a mammal in an amount to produce an in situ formed hydrogel polymer that is biocompatible and has a cure time after mixing of about 10 seconds to about 30 minutes and wherein the volume of said hydrogel polymer swells less than 30 percent after curing and hydration. Some embodiments of the inflation material may include radiopaque material such as sodium iodide, potassium iodide, barium sulfate, Visipaque 320, Hypaque, Omnipaque 350, Hexabrix and the like. For some inflation material embodiments, the polyglycidyl ether may be selected from trimethylolpropane triglycidyl ether, sorbitol polyglycidyl ether, polyglycerol polyglycidyl ether, pentaerythritol polyglycidyl ether, diglycerol polyglycidyl ether, glycerol polyglycidyl ether, trimethylolpropane polyglycidyl ether, polyethylene glycol diglycidyl ether, resorcinol diglycidyl ether, glycidyl ester ether of p-hydroxy benzoic acid, neopentyl glycol diglycidyl ether, 1,6-hexanediol diglycidyl ether, bisphenol A (PO)2 diglycidyl ether, hydroquinone diglycidyl ether, bisphenol S diglycidyl ether, terephthalic acid diglycidyl ester, and mixtures thereof. For some inflation material embodiments, the diamine may be selected from (poly)alkylene glycol having amino or alkylamino termini selected from the group consisting of polyethylene glycol (400) diamine, di-(3-aminopropyl) diethylene glycol r, polyoxypropylenediamine, polyetherdiamine, polyoxyethylenediamine, triethyleneglycol diamine and mixtures thereof. For some embodiments, the diamine may be hydrophilic and the polyglycidyl ether may be hydrophilic prior to curing. For some embodiments, the diamine may be hydrophilic and the polyglycidyl ether is hydrophobic prior to curing. For some embodiments, the diamine may be hydrophobic and the polyglycidyl ether may be hydrophilic prior to curing.
The network of inflatable channels 136 may be partially or fully inflated by injection of a suitable inflation material into the main fill port 116 to provide rigidity to the network of inflatable channels 136 and the graft 114. In addition, a seal is produced between the inflatable cuff 134 and the inside surface of the abdominal aorta 10. Although it is desirable to partially or fully inflate the network of inflatable channels 136 of the graft 114 at this stage of the deployment process, such inflation step optionally may be accomplished at a later stage if necessary.
Once the graft 114 is deployed and the inflatable channels 136 thereof have been filled and expanded, the occlusion balloon 200 may be deflated, as depicted in
Once the graft 114 is deployed and the inflatable channels 136 thereof have been filled and expanded, another delivery catheter (not shown) may be used to deploy a contralateral graft extension 138, as depicted in
For some deployment embodiments, the patient's hypogastric arteries may be used to serve as a positioning reference point to ensure that the hypogastric arteries are not blocked by the deployment. Upon such a deployment, the distal end of a graft extension 138 or 140 may be deployed anywhere within a length of the ipsilateral leg 126 or contralateral leg 128 of the graft 114. Also, although only one graft extension 140, 138 is shown deployed on the ipsilateral side and contralateral side of the graft assembly 114, additional graft extensions 140, 138 may be deployed within the already deployed graft extensions 140, 138 in order to achieve a desired length extension of the ipsilateral leg 126 or contralateral leg 128. For some embodiments, about 1 to about 5 graft extensions 138, 140 may be deployed on either the ipsilateral or contralateral sides of the graft assembly 114. Successive graft extensions 138, 140 may be deployed within each other so as to longitudinally overlap fluid flow lumens of successive graft extensions. Such successive graft extensions are not limited to the use in treatment of AAA, but may also be used in other treatments, such as internal iliac preservation.
Graft extensions 138, 140, which may be interchangeable for some embodiments, or any other suitable extension devices or portions of the main graft section 124 may include a variety of suitable configurations. For some embodiments, graft extensions 138, 140 may include a polytetrafluoroethylene (PTFE) graft 143 with helical nitinol stent 144, although any suitable materials may be used for the graft and/or stent, if used.
Further details of the endovascular prosthesis 106 and/or graft extensions 138, 140 may be found in commonly owned U.S. Pat. Nos. 6,395,019; 7,081,129; 7,147,660; 7,147,661; 7,150,758; 7,615,071; 7,766,954 and 8,167,927 and commonly owned U.S. Published Application No. 2009/0099649, the contents of all of which are incorporated herein by reference in their entirety. Details for the manufacture of the endovascular prosthesis 106 may be found in commonly owned U.S. Pat. Nos. 6,776,604; 7,090,693; 7,125,464; 7,147,455; 7,678,217 and 7,682,475, the contents of all of which are incorporated herein by reference in their entirety. Useful inflation materials for the inflatable graft 114 may be found in may be found in commonly owned U.S. Published Application No. 2005/0158272 and 2006/0222596, the contents of all of which are incorporated herein by reference in their entirety. Additional details concerning delivery details, including systems, devices and methods, of the ipsilateral graft leg 126 and the contralateral leg 128 may be found in commonly owned U.S. Published Application No. 2013/0338760, the contents of which are incorporated the herein by reference in their entirety. Additional details of an endovascular delivery system having an improved radiopaque marker system for accurate prosthesis delivery may be found in commonly owned U.S. Published Application No. 2013/0338752, the contents of which are incorporated the herein by reference in their entirety. Additional details of useful endovascular delivery systems and endovascular devices may be found in commonly owned U.S. Pat. Nos. 6,602,280; 6,733,521; 6,761,733; 7,066,951; 7,241,276; 7,338,518; 7,901,379; 8,066,755; 8,083,789; 8,226,701; 8,328,861; and 8,663,309; the contents of all of which are incorporated in their entirety herein; in commonly owned U.S. Patent Application Publication Nos. 2003/0004560; 2004/0138734; 2006/0009833; 2009/0082841; 2009/0082845; 2009/0082846; 2009/0082847; 2009/0099649; 2009/0132026; 2010/0083870; 2011/0218609; 2012/0083870; 2012/0191174; 2013/0090715; 2013/0268044; 2013/0268048; 2014/0135899; and 2014/0350656; the contents of all of which are incorporated in their entirety herein; and in commonly owned International PCT Publication Nos. WO 2009/042789 A2; WO 2009/064923 A2; WO 2011/100367 A2; WO 2013/151896 A1; and WO 2013/151924 A1; the contents of all of which are incorporated in their entirety herein.
Useful graft materials for the endovascular prosthesis 106 include, but are not limited, polyethylene; polypropylene; polyvinyl chloride; polytetrafluoroethylene (PTFE); fluorinated ethylene propylene; fluorinated ethylene propylene; polyvinyl acetate; polystyrene; poly(ethylene terephthalate); naphthalene dicarboxylate derivatives, such as polyethylene naphthalate, polybutylene naphthalate, polytrimethylene naphthalate and trimethylenediol naphthalate; polyurethane, polyurea; silicone rubbers; polyamides; polyimides; polycarbonates; polyaldehydes; polyether ether ketone; natural rubbers; polyester copolymers; silicone; styrene-butadiene copolymers; polyethers; such as fully or partially halogenated polyethers; and copolymers and combinations thereof. In some embodiments, the graft materials are non-textile graft materials, e.g., materials that are not woven, knitted, filament-spun, etc. that may be used with textile grafts. Such useful graft material may be extruded materials. Particularly useful materials include porous polytetrafluoroethylene without discernable node and fibril microstructure and (wet) stretched PTFE layer having low or substantially no fluid permeability that includes a closed cell microstructure having high density regions whose grain boundaries are directly interconnected to grain boundaries of adjacent high density regions and having substantially no node and fibril microstructure, and porous PTFE having no or substantially no fluid permeability. Such PTFE layers may lack distinct, parallel fibrils that interconnect adjacent nodes of ePTFE, typically have no discernable node and fibril microstructure when viewed at a magnification of up to 20,000. A porous PTFE layer having no or substantially no fluid permeability may have a Gurley Number of greater than about 12 hours, or up to a Gurley Number that is essentially infinite, or too high to measure, indicating no measurable fluid permeability. Some PTFE layers having substantially no fluid permeability may have a Gurley Number at 100 cc of air of greater than about 106 seconds. The Gurley Number is determined by measuring the time necessary for a given volume of air, typically, 25 cc, 100 cc or 300 cc, to flow through a standard 1 square inch of material or film under a standard pressure, such as 12.4 cm column of water. Such testing maybe carried out with a Gurley Densometer, made by Gurley Precision Instruments, Troy, N.Y. Details of such useful PTFE materials and methods for manufacture of the same may be found in commonly owned U.S. Patent Application Publication No. 2006/0233991, the contents of which are incorporated herein by reference in their entirety.
The flush port 154 for the outer sheath 104 may be used to flush the outer sheath 104 during delivery stages. The outer sheath 104 may have a radiopaque marker band to aid the practitioner in properly navigating the delivery system 100 to the desired bodily site. The outer sheath 104 is retractable by movement of the retraction knob or handle 152 for the outer sheath 104 by a practitioner towards the proximal handle assembly 170 of the delivery system 100. The inner tubular member or hypotube 150 is disposed from the inner tubular member or hypotube 150 toward a proximal portion of the delivery system 100. The inflation material or polymer fill connector port 158 and the inflation material or polymer fill cap 160 are useful for providing inflation material (e.g., polymeric fill material) to inflate proximal inflatable cuffs 134 and the network of inflatable channels 136 of the inflatable graft 114. The guidewire flush port 162 and the guidewire flush port cap 164 are useful for flushing the guidewire port 166 during delivery stages of the delivery system 100. The nested stent release knobs 168 contains a series of nested knobs (not shown) that that are used to engage release mechanisms for delivery of the endovascular prosthesis 106. Further details, including but not limited to methods, catheters and systems, for deployment of endovascular prostheses are disclosed in commonly owned U.S. Pat. Nos. 6,761,733 and 6,733,521 and commonly owned U.S. Patent Application Publication Nos. 2006/0009833 and 2009/0099649, all of which are incorporated by reference herein in their entirety.
One useful metallic material for the hypotube 150 may be 316 or 304 stainless steel. Other biocompatible materials may suitably be used, such as but not limited to, nitinol, cobalt-based alloy such as Elgiloy, platinum, gold, titanium, tantalum, niobium, and combinations thereof. The hypotube 150 may have a smooth exterior surface, such as one having a surface finish of less than or equal to about 32 microinches RMS. RMS is a measure of the smoothness of a surface. RMS refers to the Root Mean Square (RMS) of the average of measured peaks and valleys of a material surface profile calculated from a number of measurements along a sample length or area. Such RMS values are typically measured pursuant to ASTM D7127-015, the contents of which are incorporated herein by reference. RMS values from about 16 microinches to about 32 microinches are also useful.
Additional details concerning the hypotube 150 may be found in commonly owned U.S. Published Application No. 2013/0338753, the contents of which are incorporated the herein by reference in their entirety.
Typically, the occlusion balloon 200 will remain inflated until the endovascular prosthesis 106 is deployed. Further, if graft extension 138, 140 are to be deployed, then the occlusion balloon 200 will typically remain inflated during their deployment. The present invention, however, is not so limited. The occlusion balloon 200 may be inflated, may remain inflated, may be partially deflated, may be deflated or even may be re-inflated after deflation (partial or total) during the EVAR procedure as required or desired by a practitioner. For example, a practitioner may partially deflate or depressurize the occlusion balloon 200 after the main graft body 124 has been deployed so to allow temporary perfusion of the vessels, such as aorta 10, renal arteries 12, iliac arteries 14, 16, hypogastric arteries 18, and the like. Such partial depressurization allows temporary blood flow, but is not depressurized to an extent where hemostasis may be lost. After such partial depressurization of the occlusion balloon 200, the practitioner may move the occlusion balloon 200 distally a few centimeters, such as about 2, 3, 4, 5 cm or so, and re-inflate or re-pressurize the occlusion balloon 200 to continue occlusion while the remaining EVAR procedure is completed. The present invention, however, is not limited to partial depressurization of the occlusion balloon 200 followed by distal movement of the occlusion balloon 200. The occlusion balloon 200 may be kept in place after partial depressurization or, if desired, even moved proximally.
Radiopaque markers 202 may be disposed on the guidewire 102 to aid in the visualization of the balloon under, for example, fluoroscopy. The radiopaque marker 202 (as well as other radiopaque markers described herein) may be a metallic band or a band of radiopaque material in, for example, a polymeric material. For example, a radiopaque marker may be made from a polymeric material which may also include radiopaque materials, such as metallic-based powders or ceramic-based powders, particulates or pastes which may be incorporated into the polymeric material. Various radiopaque materials and their salts and derivatives may be used including, without limitation, bismuth, barium and its salts such as barium sulfate, tantalum, tungsten, gold, platinum and titanium, to name a few. Metallic complexes useful as radiopaque materials are also contemplated.
While the optional radiopaque markers 202 are depicted as being on or associated with the guidewire 102 proximally before and after the occlusion balloon 202 in
While the occlusion balloon 200 is depicted in
Commercial compliant balloons with elastomeric materials may include relatively thick walls of at least about 0.015 inches (0.38 mm). Commercial non-compliant and semi-compliant balloons often include wall thicknesses of at least about several thousands of an inch, such as 0.005 inches (0.13 mm).
The occlusion balloon 200 of the present invention may be a compliant, semi-compliant or non-compliant with a wall thickness of about 0.001 inches (0.025 mm). Slightly larger or slightly smaller wall thicknesses may be used, such as but not limited to about 0.0005 inches (0.01 mm) to about 0.003 inches (0.08 mm). The occlusion balloon 200 of the present invention typically is sized or initially formed at a size larger than the target bodily lumen, such as aorta 10.
Several standard commercial aortic occlusion balloons are Cook's Coda® and Medtronic's Reliant® balloons. The Cook recommends a 12 French (4 mm) introducer for the 32 mm balloon and a 14 French (4.7 mm) introducer for the 40 mm balloon for its Coda® balloons. Medtronic recommends a 12 French (4 mm) introducer for the up to 46 mm balloon for its Reliant® balloons. These balloons are too large in delivery diameter to fit into the delivery system 100 of the present invention. Indeed, the delivery catheter shaft itself is 9 French (3 mm) for the Coda® balloon and 8 French (2.7 mm) for the Reliant® balloon.
In order to reduce the balloon catheter device to a 10 French introducer, the delivery shaft under the balloon may also be reduced which reduces the cross-section of the inflation/deflation lumen resulting in longer inflation and deflation times. For example, a smaller (7 French-7.5 French) balloon mounting shaft may be used to obtain such a 10 French introducer compatibility. This reduces the pressure drop along the length of the delivery catheter in order to maintain the rapid inflation/deflation times of the balloon in order to maintain competitiveness with existing balloons.
The guidewire 102 of the present invention has an outer diameter of about 0.035 inches (0.9 mm) or about 3 French. This diameter is not limiting and may vary from about 0.025 inches (0.64 mm) to about 0.045 inches (1.1 mm) depending upon the French size of the delivery system 100 of the present invention. The length of the guidewire 102 with the occlusion balloon 200 is typically long enough to accommodate the delivery system, such as endovascular delivery system 100. A total, non-limiting, length may be about 150 cm to about 180 cm, but other lengths may suitable be used. Moreover, the guidewire 102 may have varying stiffness along its length. For example, the guidewire 102 may be stiffer at a location distal to the occlusion balloon 200. This may be desirable for situations where more column strength is needed to support the occlusion balloon 200 when the occlusion balloon 200 needs to be moved, for example moved proximally for anatomical reasons, procedural reasons, etc. Such increased stiffness may be accomplished by any suitable means, such as but not limited to the use of more material, such as a larger diameter guidewire portion, the use of material that is inherently stiffer than other portions of the guidewire 102, the use of composite material with greater stiffness, and the like. A non-limiting increased wire diameter portion may include a portion with a diameter of about 0.04 inches (1.02 mm).
As depicted in the embodiment of
As depicted in
As depicted in an embodiment of
The luer fitting 230 is useful for inflating or deflating the occlusion balloon 200. The occlusion balloon 200 may be inflated and deflated with a syringe or other suitable device. A useful syringe 250 is depicted in
While the occlusion balloon 200 and the guidewire 102 assembly, such as depicted in
In either a REBO situation or in a prosthesis delivery situation, the guidewire 102 may include a distal end portion 224 having reduced stiffness and greater flexibility, such as a floppy tip portion. The overall length of the distal portion 222 (i.e., from the distal portion of the balloon to the distal end of the guidewire) of the guidewire may be from about 20 cm to about 30 cm. The first about 5 cm to about 10 cm of the distal portion 222 proximal to the balloon 200 may be stiff for delivery considerations, thereafter followed by a floppy tip or end portion. A floppy tip may especially be useful in REBO applications, where the need for rapid deployment of the balloon 200 may be critical and where the floppy tip will minimize any additional trauma in such rapid deployment. The proximal portion 220 of the guidewire 102 may vary in length. For example the proximal portion 220 may vary from about 60 cm to 100 cm or more. The overall length of the guidewire 102 may be from 100 cm to 120 cm. The longer the guidewire length, the greater pressure drop or resistance to fluid flow, i.e., inflation material, will be present. To provide flexibility, for example in REBO situations, then proximal portion 220 of the guidewire 102 may be segmented such that its length man be easily changed in critical trauma situations to provide for as rapid balloon inflation times as possible. The above dimensional lengths for the guidewire and guidewire portions are non-limiting, and other lengths may suitably be used. In an embodiment of a REBO application, the balloon 200 may be a non-compliant or semi-compliant balloon. As described above, in an embodiment of an EVAR application, the balloon 200 may be a non-compliant, semi-compliant or compliant balloon.
The following embodiments or aspects of the invention may be combined in any fashion and combination and be within the scope of the present invention, as follows:
An endovascular delivery system (100), comprising:
a prosthesis (106) comprising a main tubular body (124) having an open proximal end and opposed open ipsilateral and contralateral legs (126, 128);
an elongate outer tubular sheath (104) having an open lumen and opposed proximal and distal ends with a medial portion therein between;
an elongate inner tubular member (150) slidably disposed within the open lumen of the outer tubular sheath (104); wherein the distal end of the outer tubular sheath (104) being slidably disposed past and beyond the distal end of the inner tubular member (150) to define a prosthesis delivery state and slidably retractable to the medial portion of the inner tubular member (150) to define a prosthesis unsheathed state;
an elongate guidewire (102) slidably disposed within the inner tubular member (150) and extending from the handle assembly (170), through the ipsilateral leg (126) of the prosthesis (106) and through the main tubular body (124) of the prosthesis (106) and extending past the open of the main tubular body (124) in the prosthesis delivery state; and
an inflatable occlusion balloon (200) disposed on a portion of the elongate guidewire (102) extending past the open end of the main tubular body (124);
wherein the elongate guidewire (102) comprises a hollow portion (206) such that the inflatable occlusion balloon (200) is in fluid communication with a balloon inflation material.
The endovascular delivery system (100) of Embodiment 1, wherein said main tubular body (124) comprising an inflatable cuff (134) disposed near the open proximal end.
The endovascular delivery system (100) of Embodiment 2, wherein the portion of the elongate guidewire (102) over which the occlusion balloon (200) is disposed has porosity (204) for ingress and egress of the balloon inflation material.
The endovascular delivery system (100) of Embodiment 3, wherein the porosity (204) is a plurality of holes (204) disposed through the elongate guidewire (102).
The endovascular delivery system (100) of Embodiment 2, wherein the balloon inflation material comprises saline and contrast material.
The endovascular delivery system (100) of Embodiment 1, wherein the elongate guidewire (102) comprises a metallic material.
The endovascular delivery system (100) of Embodiment 1, wherein the elongate guidewire (102) comprises a polymeric material.
The endovascular delivery system (100) of Embodiment 7, further comprising a removable mandrel (210) disposed within the elongate guidewire (102) for supporting elongate guidewire (102) prior to inflation of the occlusion balloon (200).
The endovascular delivery system (100) of Embodiment 1, further comprising a seal (212) disposed on a proximal portion of the elongate guidewire (102), such as a portion disposed within the handle assembly (170).
The endovascular delivery system (100) of Embodiment 1, wherein said ipsilateral and contralateral legs (126, 128) comprise inflatable channels (136).
The endovascular delivery system (100) of Embodiment 1, further comprising a first radiopaque marker (202) disposed on a portion of the elongate guidewire (102) just past the occlusion balloon (200).
The endovascular delivery system (100) of Embodiment 11, further comprising a second radiopaque marker (202) disposed on a portion of the elongate guidewire (102) just prior the occlusion balloon (200).
An endovascular delivery system (100), comprising:
a prosthesis (106) comprising a main tubular body (124) having an open end and opposed open end;
an elongate outer tubular sheath (104) having an open lumen and opposed proximal and distal ends with a medial portion therein between;
an elongate inner tubular member (150) slidably disposed within the open lumen of the outer tubular sheath (104); wherein the distal end of the outer tubular sheath (104) being slidably disposed past and beyond the distal end of the inner tubular member (150) to define a prosthesis delivery state and slidably retractable to the medial portion of the inner tubular member (150) to define a prosthesis unsheathed state;
an elongate guidewire (102) slidably disposed within the inner tubular member (150) and extending from the handle assembly (170) through the main tubular body (124) of the prosthesis (106) and extending past the open of the main tubular body (124) in the prosthesis delivery state; and
an inflatable occlusion balloon (200) disposed on a portion of the elongate guidewire (102) extending past the open end of the main tubular body (124).
The endovascular delivery system (100) of Embodiment 13, wherein the prosthesis (106) is a bifurcated prosthesis having open ipsilateral and contralateral legs (126, 128) at the opposed open end.
A method for delivering a bifurcated prosthesis, comprising:
providing the endovascular delivery system (100) of Embodiment 1;
advancing the endovascular delivery system (100) through a first branched artery (14) and into an aneurysm (20) in a main artery (10);
retracting the outer sheath (104) so that the proximal end of the main tubular body (124) of the prosthesis (106) is disposed beyond the aneurysm (20) and so that the ipsilateral and contralateral legs (126, 128) are disposed within the aneurysm (20);
inflating the occlusion balloon (200) with an inflation material in the main artery (10) beyond the aneurysm (20) to provide a seal against blood flow thereat;
deploying the prosthesis (106); and
deflating the occlusion balloon (200).
The method of Embodiment 15 further comprising:
deploying a contralateral graft extension (138) having opposed proximal and distal open ends contained within a catheter so that the proximal end of the contralateral graft extension (138) is disposed within a portion of the contralateral leg (128) of the main tubular body (124) of the prosthesis (106) and so that the distal end of the contralateral graft extension (138) is disposed distally of the aneurysm (20) and within a portion of a second branched artery (16).
The method of Embodiment 15 further comprising:
deploying a ipsilateral graft extension (140) having opposed proximal and distal open ends contained within a second catheter so that the proximal end of the ipsilateral graft extension (140) is disposed within a portion of the ipsilateral leg (126) of the main tubular body (124) of the prosthesis (106) and so that the distal end of the ipsilateral graft extension (140) is disposed distally of the aneurysm (20) and within a portion of the first branched artery (14).
An assembly (228) for rapid endovascular balloon occlusion, comprising:
a guidewire (102) having a hollow lumen portion (206), a proximal portion (220), a distal portion (222) and a balloon mounting portion therein between;
a non-compliant or semi-compliant occlusion balloon (200) securably disposed on the balloon mounting portion of the guidewire (102) and in fluid communication with the hollow lumen portion (206); and
a catheter (226) having a sheath (227) having the non-compliant or semi-compliant balloon (200) and portions of the guidewire (102) slidably disposed therein.
The assembly (228) of Embodiment 18, further comprising:
a syringe (250) having inflation material for inflating the non-compliant or semi-compliant balloon (200); and a luer fitting (230) for providing fluid communication of the inflation material to the hollow lumen portion (206) of the guidewire (102).
The assembly (228) of Embodiment 18, wherein the guidewire (102) has an outer diameter of about 0.035 inches and a hollow lumen diameter of about 0.015 inches to about 0.030 inches.
A method for rapid endovascular balloon occlusion, comprising:
providing a guidewire (102) having a hollow lumen portion (102), a proximal portion (220), a distal portion (224) and a balloon mounting portion therein between;
providing a non-compliant or semi-compliant occlusion balloon (200) securably disposed on the balloon mounting portion of the guidewire (102) and in fluid communication with the hollow lumen portion (206);
providing a catheter (226) having a sheath (227) having the non-compliant or semi-compliant balloon (200) and portions of the guidewire (102) slidably disposed therein;
providing a syringe (250) having inflation material for inflating the non-compliant or semi-compliant balloon (200); and a luer fitting (230) for providing fluid communication of the inflation material to the hollow lumen portion (206) of the guidewire (102);
delivering the catheter (226) to a desired bodily location;
withdrawing the sheath (227) of the catheter (226) to expose the occlusion balloon (200);
and
inflating the occlusion balloon (200) with the inflation material.
The method of Embodiment 21, wherein the occlusion balloon (200) is inflated with the inflation material within about 15 to about 30 seconds.
The method of Embodiment 21, wherein the guidewire (102) has an outer diameter of about 0.035 inches and a hollow lumen diameter of about 0.015 inches to about 0.030 inches.
While various embodiments of the present invention are specifically illustrated and/or described herein, it will be appreciated that modifications and variations of the present invention may be effected by those skilled in the art without departing from the spirit and intended scope of the invention. Further, any of the embodiments or aspects of the invention as described in the claims or in the specification may be used with one and another without limitation.
This application claims the benefit of U.S. Provisional Application No. 61/950,461, filed Mar. 10, 2014, the contents of which are incorporated by reference herein.
| Number | Date | Country | |
|---|---|---|---|
| 61950461 | Mar 2014 | US |
