Tapered and distally stented elephant trunk stent graft

BACKGROUND

1. Technical Field

This invention relates to medical devices and, more particularly, to vascular prostheses suitable for various medical applications and the methods for making and using such vascular prostheses.

2. Background Information

Throughout this specification, when discussing the application of this invention to the aorta or other blood vessels, the term “distal” with respect to an abdominal device is intended to refer to a location that is, or a portion of the device that when implanted is, further downstream with respect to blood flow; the term “distally” means in the direction of blood flow or further downstream. The term “proximal” is intended to refer to a location that is, or a portion of the device that when implanted is, further upstream with respect to blood flow; the term “proximally” means in the direction opposite to the direction of blood flow or further upstream.

The functional vessels of human and animal bodies, such as blood vessels and ducts, occasionally weaken or even rupture. For example, the aortic wall can weaken, resulting in an aneurysm. Upon further exposure to hemodynamic forces, such an aneurysm can rupture. In Western European and Australian men who are between 60 and 75 years of age, aortic aneurysms greater than 29 mm in diameter are found in 6.9% of the population, and those greater than 40 mm are present in 1.8% of the population. In particular, aneurysms and dissections that extend into the thoracic aorta and aortic arch are associated with a high morbidity and are, in some situations, particularly difficult to treat.

One intervention for a weakened, aneurismal, dissected or ruptured aorta is the use of an endovascular device or prosthesis such as a stent graft to provide some or all of the functionality of the original, healthy vessel and/or preserve any remaining vascular integrity by replacing a length of the existing vessel wall that contains the site of vessel weakness or failure. Stent grafts for endovascular deployment are generally formed from a tube of a biocompatible material in combination with one or more stents to maintain a lumen therethrough. Stent grafts effectively exclude the defect by sealing both proximally and distally to the defect, and shunting blood through its length. A device of this type can, for example, treat various arterial aneurysms, including those in the thoracic aorta or abdominal aorta.

Open surgical (i.e., non-endovascular) intervention can also be an approach to treating aneurysms or other defects of the aorta. For example, a section of the aorta that spans an aneurysm can be replaced during open surgery with a woven polyester graft, or the graft may be sewn into the aorta using traditional surgical techniques. There are benefits to both endovascular and non-endovascular treatments for conditions of the aorta. Hybrid surgical-endovascular approaches have been described in the literature, including in Greenberg, et al., “Hybrid Approaches to Thoracic Aortic Aneurysms,” Circulation 2005; 112:2619-2626 and Kark, et al., “The frozen elephant trunk technique,” J Thorac Cardiovasc Surg 2003; 125:1550-3, both of which are incorporated herein by reference.

BRIEF SUMMARY

In one aspect of the invention, there is a method of deploying an aortic stent graft that comprises providing a tapered tubular graft having a distal end and a proximal end, providing at least one stent attached to the graft at a site adjacent the distal end of the graft, loading the graft into an introducer, inserting the introducer into the aorta through an incision, deploying the graft inside the aorta; and suturing the proximal end of the graft in place.

In another aspect of the invention, there is a method of deploying an aortic stent graft that comprises providing a tubular graft having a distal end and a proximal end and providing at least one stent attached to the graft at a site adjacent the distal end of the graft. Barbs extend proximally from the at least one stent. The method further comprises loading the graft into an introducer, inserting the introducer into the aorta through an incision, deploying the graft inside the aorta and suturing the proximal end of the graft in place.

In yet another aspect of the invention, there is a stent graft for implantation in an aorta that comprises a tapered tubular graft having a distal end and a proximal end, and at least one stent attached to the graft at a site adjacent the distal end of the graft. The proximal end is adapted for stent-free connection to the aorta.

In yet another aspect of the invention, there is a stent graft for implantation in an aorta that comprises a tubular graft having a distal end and a proximal end, at least one stent attached to the graft at a site adjacent the distal end of the graft and barbs extending from the at least one stent. The proximal end is adapted to being connected to the aorta without the assistance of a stent.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 shows a stent graft having stents at the distal end;

FIG. 2 shows the stent graft of FIG. 1 with the addition of a scallop at the proximal end;

FIG. 3
a shows a stent graft sutured at its proximal end to a preexisting graft;

FIG. 3
b shows an island sutured to a graft that extends into the ascending aorta;

FIG. 4
a shows a stent graft similar to that of FIG. 1, having an uncovered stent at its distal end;

FIG. 4
b shows a shorter version of the graft of FIG. 4a;

FIG. 5
a shows a detailed view of a stent graft with stents at its distal end;

FIG. 5
b shows an internal view of the stent graft of FIG. 5;

FIG. 6 shows a variation of the stent graft of FIG. 5a;

FIG. 7 shows a sealing cuff;

FIGS. 8-15 show various views of a first introducer in different stages of deployment; and

FIGS. 16-17 show a second exemplary introducer.

DETAILED DESCRIPTION

To help understand this description, the following definitions are provided.

The term “prosthesis” means any replacement for a body part or function of that body part. It can also mean a device that enhances or adds functionality to a physiological system.

The term “endovascular” describes objects that are found or can be placed inside a lumen in the human or animal body. A lumen can be an existing lumen or a lumen created by surgical intervention. This includes lumens such as blood vessels, parts of the gastrointestinal tract, ducts such as bile ducts, parts of the respiratory system, etc. An “endovascular prosthesis” is thus a prosthesis that can be placed inside one of these lumens. A stent graft is a type of endovascular prosthesis that has a graft component and a stent component.

The term “stent” means any device or structure that adds rigidity, expansion force or support to a prosthesis. A “Z-stent” is a stent that has alternating struts and peaks (i.e., bends) and defines a generally cylindrical space. A “Gianturco Z-stent” is a type of self-expanding Z-stent.

The term “prosthetic trunk” refers to a portion of a prosthesis that shunts blood through a main vessel. A “trunk lumen” runs through the prosthetic trunk.

The term “prosthetic side branch” refers to a portion of a prosthesis that is anastomosed to the prosthetic trunk and shunts blood into and/or through a side branch vessel. An integral prosthetic side branch is one that has been connected to the trunk or formed with the trunk before deployment within the body.

“Anastomosis” refers to any existing or established connection between two lumens, such as the prosthetic trunk and prosthetic branch, that puts the two in fluid communication with each other. An anastomosis is not limited to a surgical connection between blood vessels, and includes a connection between a prosthetic branch and a prosthetic trunk that are formed integrally.

The term “branch extension” refers to a prosthetic module that can be deployed within a branch vessel and connected to a prosthetic branch.

The term “pull-out force” means the maximum force of resistance to partial or full dislocation provided by a modular prosthesis. The pull-out force of a prosthesis having two interconnected modules may be measured by an MTS ALLIANCE RT/5® tensile testing machine (MTS Corporation, Eden Prairie, Minn.). The MTS machine is connected to a computer terminal that is used to control the machine, collect and process the data. A pressurization pump system is attached to the load cell located on the tensile arm of the MTS machine. One end of the prosthesis is connected to the pressurization pump, which provides an internal pressure of 60 mm Hg to simulate the radial pressure exerted by blood upon the device when deployed in vivo. The other end of the prosthesis is sealed. The prosthesis is completely immersed in a 37° C. water bath during the testing to simulate mean human body temperature. The MTS machine pulls the devices at 0.1 mm increments until the devices are completely separated. The computer will record, inter alia, the highest force with which the modules resist separation, i.e. the pull-out force.

Biocompatible fabrics, non-woven materials and porous sheets may be used as the graft material. The graft material is preferably a woven polyester having a twill weave and a porosity of about 350 ml/min/cm²(available from VASCUTEK® Ltd., Renfrewshire, Scotland, UK). The graft material may also be other polyester fabrics, polytetrafluoroethylene (PTFE), expanded PTFE, and other synthetic materials known to those of skill in the art.

The graft material may include extracellular matrix materials. The “extracellular matrix” is a collagen-rich substance that is found in between cells in animal tissue and serves as a structural element in tissues. It is typically a complex mixture of polysaccharides and proteins secreted by cells. The extracellular matrix can be isolated and treated in a variety of ways. Following isolation and treatment, it is referred to as an “extracellular matrix material,” or ECMM. ECMMs may be isolated from submucosa (including small intestine submucosa), stomach submucosa, urinary bladder submucosa, tissue mucosa, renal capsule, dura mater, liver basement membrane, pericardium or other tissues.

Purified tela submucosa, a preferred type of ECMM, has been previously described in U.S. Pat. Nos. 6,206,931; 6,358,284 and 6,666,892 as a bio-compatible, non-thrombogenic material that enhances the repair of damaged or diseased host tissues. U.S. Pat. Nos. 6,206,931; 6,358,284 and 6,666,892 are incorporated herein by reference. Purified submucosa extracted from the small intestine (“small intestine submucosa” or “SIS”) is a more preferred type of ECMM for use in this invention. Another type of ECMM, isolated from liver basement membrane, is described in U.S. Pat. No. 6,379,710, which is incorporated herein by reference. ECMM may also be isolated from pericardium, as described in U.S. Pat. No. 4,502,159, which is also incorporated herein by reference. Other examples of ECMMs are stomach submucosa, liver basement membrane, urinary bladder submucosa, tissue mucosa and dura mater. SIS can be made in the fashion described in U.S. Pat. No. 4,902,508 to Badylak et al.; U.S. Pat. No. 5,733,337 to Carr; U.S. Pat. No. 6,206,931 to Cook et al.; U.S. Pat. No. 6,358,284 to Fearnot et al.; 17 Nature Biotechnology 1083 (November 1999); and WIPO Publication WO 98/22158 of May 28, 1998 to Cook et al., which is the published application of PCT/US97/14855; all of these references are incorporated herein by reference. It is also preferable that the material is non-porous so that it does not leak or sweat under physiologic forces.

Thoralon

Biocompatible polyurethanes may also be employed as graft materials. One example of a biocompatible polyurethane is THORALON (THORATEC, Pleasanton, Calif.), as described in U.S. Pat. Nos. 6,939,377 and 4,675,361, both of which are incorporated herein by reference. THORALON is a polyurethane base polymer (referred to as BPS-215) blended with a siloxane containing surface modifying additive (referred to as SMA-300). The concentration of the surface modifying additive may be in the range of 0.5% to 5% by weight of the base polymer.

The SMA-300 component (THORATEC) is a polyurethane comprising polydimethylsiloxane as a soft segment and the reaction product of diphenylmethane diisocyanate (MDI) and 1,4-butanediol as a hard segment. A process for synthesizing SMA-300 is described, for example, in U.S. Pat. Nos. 4,861,830 and 4,675,361, which are incorporated herein by reference.

The BPS-215 component (THORATEC) is a segmented polyetherurethane urea containing a soft segment and a hard segment. The soft segment is made of polytetramethylene oxide (PTMO), and the hard segment is made from the reaction of 4,4′-diphenylmethane diisocyanate (MDI) and ethylene diamine (ED).

THORALON can be manipulated to provide either porous or non-porous THORALON. Porous THORALON can be formed by mixing the polyetherurethane urea (BPS-215), the surface modifying additive (SMA-300) and a particulate substance in a solvent. The particulate may be any of a variety of different particulates or pore forming agents, including inorganic salts. Preferably the particulate is insoluble in the solvent. The solvent may include dimethyl formamide (DMF), tetrahydrofuran (THF), dimethyacetamide (DMAC), dimethyl sulfoxide (DMSO) or mixtures thereof. The composition can contain from about 5 wt % to about 40 wt % polymer, and different levels of polymer within the range can be used to fine tune the viscosity needed for a given process. The composition can contain less than 5 wt % polymer for some spray application embodiments. The particulates can be mixed into the composition. For example, the mixing can be performed with a spinning blade mixer for about an hour under ambient pressure and in a temperature range of about 18° C. to about 27° C. The entire composition can be cast as a sheet, or coated onto an article such as a mandrel or a mold. In one example, the composition can be dried to remove the solvent, and then the dried material can be soaked in distilled water to dissolve the particulates and leave pores in the material. In another example, the composition can be coagulated in a bath of distilled water. Since the polymer is insoluble in the water, it will rapidly solidify, trapping some or all of the particulates. The particulates can then dissolve from the polymer, leaving pores in the material. It may be desirable to use warm water for the extraction, for example, water at a temperature of about 60° C. The resulting pore diameter can also be substantially equal to the diameter of the salt grains.

The porous polymeric sheet can have a void-to-volume ratio from about 0.40 to about 0.90. Preferably the void-to-volume ratio is from about 0.65 to about 0.80. The resulting void-to-volume ratio can be substantially equal to the ratio of salt volume to the volume of the polymer plus the salt. Void-to-volume ratio is defined as the volume of the pores divided by the total volume of the polymeric layer including the volume of the pores. The void-to-volume ratio can be measured using the protocol described in AAMI (Association for the Advancement of Medical Instrumentation) VP20-1994, Cardiovascular Implants—Vascular Prosthesis section 8.2.1.2, Method for Gravimetric Determination of Porosity. The pores in the polymer can have an average pore diameter from about 1 micron to about 400 microns. Preferably, the average pore diameter is from about 1 micron to about 100 microns; more preferably, it is from about 1 micron to about 10 microns. The average pore diameter is measured based on images from a scanning electron microscope (SEM). Formation of porous THORALON is described, for example, in U.S. Pat. No. 6,752,826 and U.S. patent application Publication No. 2003/0149471 A1, both of which are incorporated herein by reference.

Non-porous THORALON can be formed by mixing the polyetherurethane urea (BPS-215) and the surface modifying additive (SMA-300) in a solvent, such as dimethyl formamide (DMF), tetrahydrofuran (THF), dimethyacetamide (DMAC) or dimethyl sulfoxide (DMSO). The composition can contain from about 5 wt % to about 40 wt % polymer, and different levels of polymer within the range can be used to fine tune the viscosity needed for a given process. The composition can contain less than 5 wt % polymer for some spray application embodiments. The entire composition can be cast as a sheet, or coated onto an article such as a mandrel or a mold. In one example, the composition can be dried to remove the solvent.

THORALON has been used in certain vascular applications and is characterized by thromboresistance, high tensile strength, low water absorption, low critical surface tension, and good flex life. THORALON is believed to be biostable and to be useful in vivo in long term bloodcontacting applications requiring biostability and leak resistance. Because of its flexibility, THORALON is useful in larger vessels, such as the abdominal aorta, where elasticity and compliance is beneficial.

A variety of other biocompatible polyurethanes may also be employed. These include polyurethanes that preferably include a soft segment and include a hard segment formed from a diisocyanate and diamine. For example, polyurethane with soft segments such as PTMO, polyethylene oxide, polypropylene oxide, polycarbonate, polyolefin, polysiloxane (i.e. polydimethylsiloxane), and other polyether soft segments made from higher homologous series of diols may be used. Mixtures of any of the soft segments may also be used. The soft segments also may have either alcohol end groups or amine end groups. The molecular weight of the soft segments may vary from about 500 to about 5,000 g/mole.

The diisocyanate used as a component of the hard segment may be represented by the formula OCN—R—NCO, where —R— may be aliphatic, aromatic, cycloaliphatic or a mixture of aliphatic and aromatic moieties. Examples of diisocyanates include MDI, tetramethylene diisocyanate, hexamethylene diisocyanate, trimethyhexamethylene diisocyanate, tetramethylxylylene diisocyanate, 4,4′-dicyclohexylmethane diisocyanate, dimer acid diisocyanate, isophorone diisocyanate, metaxylene diisocyanate, diethylbenzene diisocyanate, decamethylene 1,10 diisocyanate, cyclohexylene 1,2-diisocyanate, 2,4-toluene diisocyanate, 2,6-toluene diisocyanate, xylene diisocyanate, m-phenylene diisocyanate, hexahydrotolylene diisocyanate (and isomers), naphthylene-1,5-diisocyanate, 1-methoxyphenyl 2,4-diisocyanate, 4,4′-biphenylene diisocyanate, 3,3′-dimethoxy-4,4′-biphenyl diisocyanate and mixtures thereof.

The diamine used as a component of the hard segment includes aliphatic amines, aromatic amines and amines containing both aliphatic and aromatic moieties. For example, diamines include ethylene diamine, propane diamines, butanediamines, hexanediamines, pentane diamines, heptane diamines, octane diamines, m-xylylene diamine, 1,4-cyclohexane diamine, 2-methypentamethylene diamine, 4,4′-methylene dianiline and mixtures thereof. The amines may also contain oxygen and/or halogen atoms in their structures.

Other applicable biocompatible polyurethanes include those using a polyol as a component of the hard segment. Polyols may be aliphatic, aromatic, cycloaliphatic or may contain a mixture of aliphatic and aromatic moieties. For example, the polyol may be ethylene glycol, diethylene glycol, triethylene glycol, 1,4-butanediol, 1,6-hexanediol, 1,8-octanediol, propylene glycols, 2,3-butylene glycol, dipropylene glycol, dibutylene glycol, glycerol, or mixtures thereof.

Biocompatible polyurethanes modified with cationic, anionic and aliphatic side chains may also be used, as in U.S. Pat. No. 5,017,664.

Other biocompatible polyurethanes include: segmented polyurethanes, such as BIOSPAN; polycarbonate urethanes, such as BIONATE; and polyetherurethanes, such as ELASTHANE; (all available from POLYMER TECHNOLOGY GROUP, Berkeley, Calif.).

Other biocompatible polyurethanes include polyurethanes having siloxane segments, also referred to as a siloxane-polyurethane. Examples of polyurethanes containing siloxane segments include polyether siloxanepolyurethanes, polycarbonate siloxane-polyurethanes, and siloxanepolyurethane ureas. Specifically, examples of siloxane-polyurethane include polymers such as ELAST-EON 2 and ELAST-EON 3 (AORTECH BIOMATERIALS, Victoria, Australia); polytetramethyleneoxide (PTMO) and polydimethylsiloxane (PDMS) polyether-based aromatic siloxanepolyurethanes such as PURSIL-10, -20, and -40 TSPU; PTMO and PDMS polyether-based aliphatic siloxane-polyurethanes such as PURSIL AL-5 and AL-10 TSPU; aliphatic, hydroxy-terminated polycarbonate and PDMS polycarbonate-based siloxane-polyurethanes such as CARBOSIL-10, -20, and -40 TSPU (all available from POLYMER TECHNOLOGY GROUP). The PURSIL, PURSIL-AL, and CARBOSIL polymers are thermoplastic elastomer urethane copolymers containing siloxane in the soft segment, and the percent siloxane in the copolymer is referred to in the grade name. For example, PURSIL-10 contains 10% siloxane. These polymers are synthesized through a multi-step bulk synthesis in which PDMS is incorporated into the polymer soft segment with PTMO (PURSIL) or an aliphatic hydroxy-terminated polycarbonate (CARBOSIL). The hard segment consists of the reaction product of an aromatic diisocyanate, MDI, with a low molecular weight glycol chain extender. In the case of PURSIL-AL, the hard segment is synthesized from an aliphatic diisocyanate. The polymer chains are then terminated with a siloxane or other surface modifying end group. Siloxane-polyurethanes typically have a relatively low glass transition temperature, which provides for polymeric materials having increased flexibility relative to many conventional materials. In addition, the siloxane-polyurethane can exhibit high hydrolytic and oxidative stability, including improved resistance to environmental stress cracking. Examples of siloxane-polyurethanes are disclosed in U.S. patent application Publication No. 2002/0187288 A1, which is incorporated herein by reference.

In addition, any of these biocompatible polyurethanes may be end-capped with surface active end groups, such as, for example, polydimethylsiloxane, fluoropolymers, polyolefin, polyethylene oxide or other suitable groups. See, for example, the surface active end groups disclosed in U.S. Pat. No. 5,589,563, which is incorporated herein by reference.

FIG. 1 shows a stent graft 10 designed for implantation in the thoracic aorta. The stent graft is formed from a section of graft material shaped into a tube. Stents 12 are positioned at the distal end 14 of the graft 10. The graft tube may be made of any of the graft materials described above, preferably woven polyester twill. The fabric may be crimped so that the graft may be able to bend without excessive kinking. The graft tube is preferably sized to correspond to a particular patient's anatomy. An exemplary graft 10 may have a length of about 140-280 mm, and may be designed to extend from a point just distal of the subclavian artery 16 to a point proximal to the celiac artery 18, as shown in FIG. 1. The stent graft 10 may be manufactured to a maximum length, and be subsequently trimmed to suit a particular patient. The diameter of an exemplary graft 10 is about 30 mm. The graft 10 is preferably tapered. For example, the proximal end 20 of the graft 10 may have a diameter of 30 mm, while the distal end 14 of the graft 10 may have a diameter of 28, 32, 36 or 44 mm. Thus, the graft 10 either tapers distally (i.e., is narrower in the distal region of the graft 10), or tapers proximally (i.e., is narrower in the proximal region of the graft 10). The taper can better allow the stent graft 10 to form a sealing interconnection with preexisting grafts.

The proximal end 20 of the stent graft 10 is preferably unstented, as it is designed to be anastomosed to the native artery with sutures 22, as shown in FIG. 1 and described in further detail below. The distal end 14, however, is preferably stented so that a seal may be formed between the stent graft 10 and the native artery following deployment of the stent graft 10, without the addition of sutures.

As shown in FIG. 1, there are preferably three self expanding Z-stents 12,13, 15 sutured to the distal end 14 of the graft 10. The distal stent 15 is preferably sutured to the inside of the graft 10, as shown in FIG. 1. This may improve the circumferential apposition of the stent graft 10 to the surrounding vessel wall. The other stents 12,13 can be sutured to the outside of the graft 10. Alternatively, two distal-most stents may be sutured to the inside of the graft and the third stent can be sutured to the outside of the stent graft 10, as shown at the distal end 162 of the graft 152 in FIG. 6. Thus, in an embodiment that has three Z-stents, the stents can have an approximate amplitude of 17.5 mm, such that the three of them, sutured to the distal end of the graft, occupy about a 60 mm length of the graft. The remainder of the graft can be about 80-85 mm, for a total length of about 140 -145 mm. There may be more stents added to the distal end, depending on the overall length of the graft, the requirements of the anatomy, etc.

Barbs or hooks 24 preferably extend in the proximal (cephalad) direction from the distal-most stent 15. Barbs 24 may also extend from the other stents 12,13. The barbs 24 may help anchor the distal end 14 of the graft 10 in place, thereby improving sealing at the distal end 14. The barbs 24 may extend from the struts or the bends of the Z-stent 15. There may be a single ring of barbs 24 extending from the stent 15, or a more extensive array of barbs as shown in FIG. 1. A single row of barbs 130 extending from the distal bends of a Z-stent is shown in FIG. 5.

As shown in FIG. 2, the proximal end 20 of the stent graft 10 may have a scallop 28 that accommodates the subclavian artery 16, allowing the stent graft 10 to be sutured at a more proximal location in the aortic arch 30, while not impeding flow to the subclavian artery 16. A proximal fenestration or an integral prosthetic branch (not shown) may also be employed for a similar purpose.

An extension for an integral prosthetic branch may be deployed. As shown in FIG. 3a, the stent graft 34 may be sutured to a preexisting prosthetic module 36. The preexisting prosthetic module 36 may have been deployed surgically or endovascularly during the same surgical procedure or a previous procedure.

The graft can also extend further proximally with the use of an open surgical procedure using the “island” surgical technique. In that technique, the aorta is clamped proximally to the innominate, left common carotid, and left subclavian arteries. An island 25 encompassing those aortic arch side branches is cut from the aorta. A graft 17 having a fenestration 27 that approximates the shape and size of the island is deployed into the aortic arch. Alternatively, the fenestration 27 can be cut after the graft's deployment. The island 25 is then sutured to the fenestration 27 and the location in the aorta from which the island was resected.

FIG. 4
a shows that the distal end 52 of the graft 40 may be modified to accommodate the branch vessels of the thoraco-abdominal aorta, such as the celiac, SMA and renal arteries. As with the subclavian, these can be accommodated with, for example, fenestrations, scallops, or integral prosthetic branches. FIG. 4a shows a stent graft 40 extending to the renal arteries 42. A celiac fenestration 44 and SMA fenestration 46 preserve blood flow to their respective arteries. The distal end 48 of the stent graft 40 features an uncovered stent 50 that extends over the renal arteries 42 without occluding them. Barbs 52 extend proximally from the uncovered stent 50.

FIG. 4
b shows a shorter graft than that of FIG. 4a. In FIG. 4b, the uncovered stent transverses the SMA 45 and celiac 47 arteries so that they are not occluded.

FIGS. 5
a and 5b show external and internal views of an embodiment of an exemplary stent graft. The stent graft 101 includes a tubular body 103 formed from a biocompatible woven or non-woven fabric, or other material. The tubular body 103 has a proximal end 105 and a distal end 107. The stent graft 101 may be tapered, as described above, depending upon the topography of the vasculature and flow considerations.

Towards the distal end 107 of the tubular body 103, there are a number of self-expanding Z-stents 109,111 such as the Z-stent on the outside of the body. In this embodiment there are two external stents 109 spaced apart by a distance of between 0 mm to 10 mm. The external stents 109 are joined to the graft material by means of stitching or suturing 110, preferably using a monofilament or braided suture material.

At the distal end 107 of the prosthetic module 101 there is provided an internal Z-stent 111 which provides a sealing function for the distal end 107 of the stent graft 101. The outer surface of the tubular body 103 at the distal end 107 presents an essentially smooth outer surface, which, with the assistance of the internal Z-stent 111, can engage and seal against the wall of the aorta when it expands and is deployed.

The internal stent 111 is comprised of struts 115 with bends 116 at each end of the struts. Affixed to some or all of the struts 115 are barbs 130 which extend proximally from the struts 115 through the graft material. When the stent graft is deployed into an aortic arch, the barbs 130 engage and/or penetrate into the wall of the aorta and prevent proximal movement of the stent graft 101 caused by pulsating blood flow through the stent graft 101. It will be noted that the stent 111 is joined to the graft material by means of stitching 112, preferably using a monofilament or braided suture material.

FIG. 6 shows a stent graft 152 that has the two distal stents attached to the inside 162 of the stent graft 152. Additional stent grafts are described in U.S. patent application Publication Nos. 2003/0199967 A1 and 2004/016978 A1, which are incorporated herein by reference.

FIG. 7 shows a three-stent cuff 150 that can be used in conjunction with the stent grafts described above. The cuff 150 may be about 55 mm in length and can have any of a variety of suitable diameters including, for example 28, 30 or 32 mm. It is preferably sized to form a-sealing interconnection with a stent graft. The stents 158 may be place internally or externally, relative to the main graft. It can be introduced with a 30 cm variation of one of the introducers described below. Once the stent graft described below is deployed, the cuff shown in FIG. 7 may be used to seal the distal or proximal end of the stent graft if it becomes apparent that the stent graft itself does not exhibit optimal sealing against the aortic wall. In particular, the sealing cuff may be used at the site of surgical anastomosis (i.e., the proximal portion of the graft), if it is discovered that the surgical anastomosis exhibits imperfect sealing. By placing a sealing cuff using endovascular techniques, surgical repair of the anastomosis may be rendered unnecessary. Such a cuff 150 may also be manufactured using two or four stents, for example.

The devices described above are implanted using a hybrid surgical procedure—one that employs aspects of open surgical repair in addition to endovascular techniques. In summary, the aortic arch is surgically exposed; then an incision is made in the aortic arch or associated branch vessel so that an introducer containing the stent graft can be inserted into the aorta. The aortic arch can be exposed using a conventional median sternotomy. The introducer is advanced distally through the aortic arch into the thoracic aorta, until it is in a proper distal position. At that point, the stent graft is released from the introducer. At the distal end of the stent graft, the stents expand, with or without the assistance of a balloon catheter, thereby forming a seal at the distal end. Then, the proximal end of the stent graft—which is preferably stent-free—is sutured to the native aorta using standard surgical techniques. Finally, the incision in the aortic arch is closed, followed by the closure of the surgical access.

Thus, using this hybrid procedure, a second surgical operation through a separate entry point—e.g., a left thoracotomy—is rendered unnecessary to ensure sealing at the distal end of the stent graft.

Exemplary introducers are described further below.

Introducer

FIGS. 8 and 9 show an exemplary introducer which may be used to deploy the stent graft described above. The introducer may be about 40 cm in length, which is shorter than the delivery systems that are used to deploy stent grafts through femoral cut-downs. For example, the TX-2 delivery system (Cook Incorporated, Bloomington, Indiana) is generally about 75 cm. The introducer, shown in FIGS. 8 and 9, is preferably about 20/22 French in diameter.

The introducer may comprise, working from the inside towards the outside, a guide wire catheter 201 which extends the full length of the device from a syringe socket 202 at the far distal end of the introducer to a nose dilator 203 at the proximal end of the introducer. The introducer may also be employed without the assistance of a guide wire, and thus will lack a guide wire catheter and associated features.

The nose cone dilator 203 is fixed to the guide wire catheter 201 and moves with it; the dilator may be about 40mm and is preferably blunt tipped. The nose cone dilator has a through bore 205 as an extension of the lumen of the guide wire catheter 201 so that the introducer can be deployed over a guide wire (not shown). To lock the guide wire catheter 201 with respect to the introducer in general, a pin vice 204 is provided. Again, a version of the introducer shown in FIGS. 8 and 9 may be designed so that it works without a guide wire, and thus, does not have the bore 205 and other features used with a guide wire.

The trigger wire release mechanism generally shown as 206 at the distal end of the introducer includes a distal end trigger wire release mechanism 207 and a proximal end trigger wire release mechanism 208. The trigger wire release mechanisms 207 and 208 slide on a portion of the fixed handle 210. Until such time as they are activated, the trigger wire mechanisms 207 and 208 are fixed by thumbscrews 211 (FIG. 9) and remain fixed with respect to the fixed portion of the fixed handle. The controlled deployment afforded by use of the trigger wires helps to ensure accurate placement of the distal portion of the graft.

Immediately proximal of the trigger wire release mechanism 206 is a sliding handle mechanism generally shown as 215. The sliding handle mechanism 215 generally includes a fixed handle extension 216 of the fixed handle 210 and a sliding portion 217. The sliding portion 217 slides over the fixed handle extension 216. A thumbscrew 218 fixes the sliding portion 217 with respect to the fixed portion 216. The fixed handle portion 216 is affixed to the trigger wire mechanism handle 210 by a screw threaded nut 224. The sliding portion of the handle 217 is fixed to the deployment catheter 219 by a mounting nut 220. A deployment catheter extends from the sliding handle 217 through to a capsule 221 at the proximal end of the deployment catheter 219.

Over the deployment catheter 219 is a sheath manipulator 222 and a sheath 223, which slide with respect to the deployment catheter 219 and, in the ready to deploy situation as shown in FIGS. 8 and 9, extend from the sheath manipulator 222 forward to the nose cone dilator 203 to cover a prosthetic module 225 retained on the introducer distally of the nose cone dilator 203.

In the ready to deploy condition shown in FIGS. 8 and 9, the sheath 223 assists in retaining stent graft 225, which includes self-expanding stents 226 in a compressed condition. The proximal covered stent 227 is retained by a fastening at 228 which is locked by a trigger wire (not shown) which extends to trigger wire release mechanism 208. The distal exposed stent 229 on the stent graft 225 is retained within the capsule 221 on the deployment catheter 219 and is prevented from being released from the capsule by a distal trigger wire (not shown), which extends to the distal trigger wire release mechanism 207.

FIG. 9 shows the same view as FIG. 8, but after withdrawal of sheath 223, and FIG. 11 shows the same view as FIG. 10, but after activation of sliding handle mechanism 215.

In FIG. 10, the sheath manipulator 222 has been moved distally so that its proximal end clears the stent graft 225 and lies over the capsule 221. Freed of constraint, the self expanding stents 226 of the stent graft 225 are able to expand. However, the fastening 228 still retains the uncovered stent 229, and the capsule 221 still retains the other stents. At this stage, the proximal and distal ends of the stent graft 225 can be independently repositioned, although if the distal stent 229 included barbs as it has in some embodiments, the proximal end can only be moved proximally.

Once repositioning has been done, the distal end of the stent graft 225 should be released first. The distal trigger wire release mechanism 207 on the handle 210 is removed to withdraw the distal trigger wire. Then the thumb screw 218 is removed, and the sliding handle 217 is moved distally to the position shown in FIG. 11. This moves the capsule 221 to release the exposed stent 229. As the fastening 228 is retained on the guide wire catheter 201, just distal of the nose cone dilator 203, and the guide wire catheter 201 is locked in position on the handle 210 by pin vice 204, then the proximal trigger wire release mechanism 208, which is on the handle 210, does not move when moving the sliding handle, deployment catheter 219 and capsule 221, so the proximal end of the prosthetic module 225 remains in a retained position. The proximal end of the prosthetic module 225 can be again manipulated at this stage by manipulation of the handle. Although, if the uncovered stent 229 included barbs as discussed above, the proximal end can only be moved proximally. The proximal fastening 228 can then be released by removal of the proximal trigger wire release mechanism 208.

As shown in FIGS. 12 and 13, the detailed construction of a particular embodiment of a sliding handle mechanism according to this invention is shown. FIGS. 12 and 14 show the sliding handle mechanism in the ready to deploy condition. FIGS. 13 and 15 show the mechanism when the deployment catheter and hence the capsule has been withdrawn by moving the sliding handle with respect to the fixed handle. The fixed handle extension 216 is joined to the trigger wire mechanism handle 210 by screw threaded nut 224.

The sliding handle 217 is fixed to the deployment catheter 219 by screw threaded fixing nut 220 so that the deployment catheter moves along with the sliding handle 217. The sliding handle 217 fits over the fixed handle extension 216 and, in the ready to deploy situation, is fixed in relation to the fixed handle by locking thumbscrew 218, which engages into a recess 230 in the fixed handle extension 216. On the opposite side of the fixed handle extension 216 is a longitudinal track 231 into which a plunger pin 232 spring loaded by means of spring 233 is engaged. At the distal end of the track 231 is a recess 234.

A guide tube 235 is fixed into the proximal end of the sliding handle 217 at 236 and extends back to engage into a central lumen 241 in the fixed handle extension 216 but is able to move in the central lumen 241. An O ring 237 seals between the fixed handle extension 216 and guide tube 235. This provides a hemostatic seal for the sliding handle mechanism. The trigger wire 238, which is fixed to the trigger wire releasing mechanism 208 by means of screw 239, passes through the annular recess 242 between the fixed handle extension 216 and the guide wire catheter 201 and then more proximally in the annular recess 244 between the guide wire catheter 201 and the guide tube 235 and forward to extend through the annular recess 246 between the guide wire catheter 201 and the deployment catheter 219 and continues forward to the proximal retaining arrangement. Similarly, the distal trigger wire (not shown) extends to the distal retaining arrangement.

A further hemostatic seal 240 is provided where the guide wire catheter 201 enters the trigger wire mechanism handle 210 and the trigger wires 238 pass through the hemostatic seal 240 to ensure a good blood seal.

As can be seen in FIGS. 13 and 15, the locking thumbscrew 218 has been removed and discarded, and as the sliding handle is moved onto the fixed handle, the plunger pin 232 has slid back along the track 231 to engage into the recess 234. At this stage, the sliding handle cannot be moved forward again.

As the trigger wire release mechanisms 207 and 208 are on the trigger wire mechanism handle 210, which is fixed with respect to the fixed handle 216, then the proximal trigger wire 238 is not moved when the deployment catheter 219 and the sliding handle 217 are moved so that it remains in position and does not prematurely disengage.

FIGS. 16 and 17 show an alternative introducer 301 that has a distal end 303 which in use is intended to remain outside a patient and a proximal end 305 which is introduced into the patient. This introducer is further described in U.S. patent application Publication No. 2004/0106974, which is incorporated herein by reference. The curved nose cone dilator 317 may help guide the introducer 301 through the aortic arch or tortuous anatomy.

Towards the distal end there is a handle arrangement 307 which includes trigger wire release apparatus 309 as will be discussed later. The main body of the introducer includes a tubular carrier 311 which extends from the handle 307 to a proximal retention arrangement, generally shown as 313.

Within a longitudinal lumen 314 in the central carrier 311 extends a guide wire catheter 315. The guide wire catheter 315 extends out through the proximal retention arrangement 313 and extends to a nose cone dilator 317 at the distal end of the introducer 301. The nose cone dilator 317 is curved, and in the embodiment shown in FIG. 39, the guide wire catheter 315 is also curved towards its distal end so that the distal end 305 of the introducer has a curve which may have a radius of curvature 319 of between 70 to 150 mm. This curvature enables the introducer of the present invention to be introduced through the aortic arch of a patient without excessive load being placed on the walls of the aorta.

A stent graft 321 is retained on the introducer between the distal end 323 of the nose cone dilator 317 and the distal retention arrangement 313. A sleeve 325 fits over the tubular carrier 311, and, by operation of a sleeve manipulator 327, the sleeve can be extended forward to extend to the nose cone dilator 317. By the use of the sleeve 325, the stent graft 321 can be held in a constrained position within the sleeve.

At the distal end of the stent graft just proximal of the proximal end 323 of the nose cone dilator 317, a distal retention arrangement 331 is provided.

The distal retention arrangement 331 includes a trigger wire 333, which engages a knot 335 of suture material, which is fastened to the trigger wire 333 and the guide wire catheter 315. When the trigger wire 333 is withdrawn as will be discussed later, the suture knot 325 is released and the distal end of the stent graft can be released. The nose cone dilator 317 can have one or more apertures extending longitudinally, and the proximal trigger wire 333 can extend into one of these apertures.

The proximal retention arrangement 313, as shown in detail in FIG. 40, includes a capsule 340, which is part of a capsule assembly 341, which is joined by a screw thread 343 to the distal end 342 of the central carrier 311. The capsule 340 includes a passageway 344 within it with a proximal closed end 346 and an open distal end 348. The open distal end 348 faces the nose cone dilator 317 and the guide wire catheter 315 passes through the center of passageway 344.

The stent graft 321 has a distal stent 348 that is received within the capsule 340, which holds it constrained during deployment. If the distal stent 348 has barbs extending from its struts, then the capsule keeps the barbs from prematurely engaging the walls of the vessel it is being deployed in and also prevents them from catching in the sleeve 325. A trigger wire 350 passes through aperture 352 in the side of the capsule, engages a loop of the exposed stent 348 within the capsule and then passes along the annular recess 354 between the guide wire catheter 315 and the tubular carrier 311 to the trigger wire release mechanism 309.

The trigger wire release mechanism 309 includes a proximal release mechanism 356 and a distal end release mechanism 358.

To release the stent graft after it has been placed in the desired position in the aorta, the sleeve 325 is withdrawn by pulling back on the sleeve manipulator 327 while holding the handle 307 stationary. The distal release mechanism 358 on the handle 307 is then released by loosening the thumb screw 364 and completely withdrawing the distal release mechanism 358, which pulls out the trigger wire 333 from the capsule 340. Pin vice 362, which fixes the position of the guide wire catheter with aspect to the handle 307 and central carrier 311, is then loosened so that the guide wire catheter 315 can be held stationary, which holds the nose cone dilator and hence the distal retention arrangement 331 stationary while the handle is pulled back to remove the capsule 340 from the exposed stent 348, which releases the distal end of the stent graft.

Once the position of the distal end of the stent graft 321 has been checked, the proximal release mechanism 358 can then be removed by release of the thumb screw 364 and complete removal of the proximal release mechanism 358.

The tubular central carrier 311 can then be advanced while holding the nose cone dilator 317 stationary so that the introducer can be made more compact for withdrawal. Then the proximal end of the stent graft can be sutured in place, as described above.

It is therefore intended that the foregoing detailed description be regarded as illustrative rather than limiting, and that it be understood that it is the following claims, including all equivalents, that are intended to define the spirit and scope of this invention.

Tapered and distally stented elephant trunk stent graft

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CPC

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