WO2000047271A1 - Tube etanche multicouches - Google Patents

Tube etanche multicouches Download PDF

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Publication number
WO2000047271A1
WO2000047271A1 PCT/US1999/002997 US9902997W WO0047271A1 WO 2000047271 A1 WO2000047271 A1 WO 2000047271A1 US 9902997 W US9902997 W US 9902997W WO 0047271 A1 WO0047271 A1 WO 0047271A1
Authority
WO
WIPO (PCT)
Prior art keywords
tube
stress
length
graft
tube element
Prior art date
Application number
PCT/US1999/002997
Other languages
English (en)
Inventor
James D. Silverman
Bret Kilgrow
Original Assignee
Gore Enterprise Holdings, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Gore Enterprise Holdings, Inc. filed Critical Gore Enterprise Holdings, Inc.
Priority to PCT/US1999/002997 priority Critical patent/WO2000047271A1/fr
Priority to AU32899/99A priority patent/AU3289999A/en
Publication of WO2000047271A1 publication Critical patent/WO2000047271A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/04—Access sites having pierceable self-sealing members
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures

Definitions

  • the present invention relates to tubular structures, such as vascular grafts and the like, that are adapted to carry a fluid stream, and particularly to tubular structures that are resistant to leakage following a puncture.
  • Tubular structures are used to carry a variety of fluid streams, including both liquids and gases. It is desirable for many of these tubular structures to be resistant to punctures, either accidental or intentional, and/or to provide some degree of self-healing following a puncture so as to minimize fluid leakage.
  • vascular grafts are used as an access site for dialysis and the like.
  • AV arterial-venous
  • these vascular grafts must withstand several punctures a week over the life of the graft. This is a highly demanding environment that inevitably leads to graft failures due to excessive numbers of puncture holes, often requiring installation of two or more grafts over the course of a year.
  • each new AV access graft generally will not function properly until it has achieved tissue ingrowth in a patient, a process that can take weeks after installation to occur adequately. Puncture of these tubes (“cannulation”) before full tissue in-growth may result in excessive subcutaneous bleeding and serious complications.
  • a number of other devices teach employing two or more layers of different materials to achieve some degree of puncture hole contraction following removal of the puncture device.
  • PTFE polytetrafluoroethylene
  • United States Patent 5,700,287 to Myers et al. describes a tube of biocompatible material wherein a substantial portion of the outer surface of the base substrate is provided with an outer covering of deflectably secured material.
  • "Deflectably secured” is defined to mean that the outer covering may move with respect to the base substrate when pierced with a needle.
  • the outer surface of deflectably secured materials may be fibers, film, or discrete pieces.
  • the Myers device has some drawbacks including difficulty in trimming to length and revising. Additionally, the Myers device is larger and less flexible than is preferred by many physicians.
  • the present invention addresses deficiencies found in prior devices. It is a purpose of the present invention to create a tubular structure that exhibits limited leakage following puncture.
  • the present invention comprises a tubular device that is resistant to leakage when punctured.
  • the device of the present invention employs a first tube element at least partially covered with a second element that is adapted to move relative to the first tube element when the device is punctured diagonally with a needle.
  • the device is constructed so that misaligned holes will be left through the device when the needle is removed, thus reducing leakage through the device.
  • a first tube element and a second tube element are mounted concentrically with one another and have an interference fit therebetween.
  • the interference fit assures that tensions or stresses applied to either or both of the tube elements will remain resident within the device in use.
  • the tube elements are adapted to move relative to one another when punctured. By maintaining different stresses on the tube elements, the result is that relative movement will more readily occur between the tube elements during and after a puncture, assuring hole misalignment following needle removal.
  • the device can be constructed to provide self-healing properties by providing one of the tube elements with a compressive stress, causing the opening in it to close-up following needle removal.
  • a first tube element and a second tube element are mounted concentrically with one another and have an interference fit therebetween and the second tube element is made from a film and has a longitudinal compressive stress applied such that the second tube becomes corrugated.
  • This corrugation results in advantages in addition to advantage of hole misalignment.
  • the corrugation of the second tube element provides a flap of extra material which assists in closing the hole in the first tube layer.
  • Another advantage, in a vascular graft application is that the corrugations provide an increased surface area and large spaces for tissue incorporation.
  • the device of the present invention is believed to have a variety of useful applications, but is particularly intended for use as an implantable device, such as a vascular graft and particularly to an AV access graft. In fact, the device of the present application is believed to be beneficially employed as an early cannulation vascular access graft.
  • the present invention can be constructed from highly bio-compatible materials, such as polytetrafluoroethylene, without the need to introduce elastomeric materials, such as silicone, which are less desirable in implantable devices. Additionally, the leak resistant properties of the present invention are achieved with little increase in the dimension of the final product, again making it especially suitable for implantation within the tight confines of a body.
  • Figure 1 is a three-quarter isometric view of one embodiment of a tubular device of the present invention
  • Figure 2 is a cross-section view of the device of Figure 1 ;
  • Figure 3 is a three-quarter isometric view of another embodiment of a tubular device of the present invention
  • Figure 4 is a cross-section view of the device of Figure 3;
  • Figure 5 is an enlarged cross-section view of a wall segment of a device of the present invention, showing a needle preparing to enter the device;
  • Figure 6 is the enlarged cross-section view of Figure 5, with the needle having penetrated an outer layer of the device;
  • Figure 7 is the enlarged cross-section view of Figure 5, with the needle having entered both the outer layer and an inner layer of the device;
  • Figure 8 is the enlarged cross-section view of Figure 5, with the needle having been removed from the device and illustrating the discontinuous nature of the openings left in the device through the outer and inner layers;
  • Figure 9 is a top plan view of the wall segment of the device of the present invention shown in Figure 8, showing the opening in the outer layer and showing in phantom the discontinuous opening in the inner layer;
  • Figure 10 is a three-quarter isometric view of another embodiment of a device of the present invention, this embodiment comprising a base tube covered with a tape-wrapped second tube;
  • Figure 1 1 is a longitudinal cross-section of the device of Figure 10;
  • Figure 12 is a three-quarter isometric view of still another embodiment of a device of the present invention, this embodiment comprising a three layer tubular construction;
  • Figure 13 is a longitudinal cross-section of the device of Figure 12;
  • Figure 14 is a three-quarter isometric view of still another embodiment of a tubular device of the present invention.
  • Figure 15 is a cross-section view along line 15 - 15 of Figure 14.
  • Figure 16 shows a cross section of a human arm with the tubular device of the present invention being used a vascular graft;
  • Figure 17 is a three-quarter isometric view of another embodiment of the present invention, this embodiment employing a strip of adhesive between the first tube element and the second tube element;
  • Figure 18 is a three-quarter isometric view of the first tubular element of the device of Figure 17;
  • Figure 19 is a three-quarter isometric view of the device of Figure 17 showing slits in the second tube element;
  • Figure 20 is a three-quarter isometric view of the device of Figure 17 showing a pair of tweezers disconnecting the second element at one of the slits;
  • Figure 21 is a longitudinal cross section of another embodiment of the tubular device of the present invention, this embodiment comprising a corrugated surface on the second tube element;
  • Figure 22a is a top view of the device of Figure 21 showing a misalignment between a hole in the first tube element and the slit hole in the second tube element;
  • Figure 22b is an enlarged longitudinal cross section at segment A-A of the device of Figure 21 before being punctured;
  • Figure 22c is the longitudinal cross section of Figure 22b, showing the flap of the second tube element filling the hole of the first tube element following a puncture;
  • Figure 22d is a longitudinal cross section of Figure 22c, showing the flap of the second tube element covering the slit hole of the second tube element following a puncture;
  • Figure 22e is a longitudinal cross section of another embodiment of the tubular device of the present invention, this embodiment comprising a corrugated surface on the second tube element mounted on the inside of the device,
  • Figure 23a is a side elevation view of another embodiment of the device of the present invention, this embodiment including partially circumferential slits located along the axis of the tubular device,
  • Figure 23b is a side elevation view of the device of Figure 23a, showing a pair of tweezers grasping the second tube element and separating the tube at one of the slits,
  • Figure 23c is a side elevation view of the device of Figure 23a, showing a pair of tweezers completely separating "disconnecting" the second tube element at one of the slits,
  • Figure 23d is a side elevation view of the device of Figure 23a, after a portion of the second tube has been removed by tweezers,
  • Figure 24 is a longitudinal cross section view showing one method of corrugating the surface of the second tube element, such as may be accomplished by hand,
  • Figure 25 is a longitudinal cross section showing a method of corrugating the surface of the second tube element by a machine process
  • Figure 26 is a photomicrograph of one embodiment of the device of the present invention showing the misalignment between the hole in the first tube element and the slit hole in the second tube element,
  • Figure 27 is a photomicrograph of another embodiment of the device of the present invention showing a close up view of the misalignment between the hole in the first tube element and the slit hole in the second tube element
  • Figure 28 is a photomicrograph of one embodiment of the device of the present invention showing a flap of the second tube element
  • Figure 29 is a histological section of the device of the present invention following implantation in a chronic canine model showing the flap of the second tube element partially filling the hole of the first tube element
  • Figure 30 is a histological section of the device of the present invention following implantation in a chronic canine model showing misalignment between the hole in the first tube element and the slit hole in the second tube element
  • the present invention is an improved tubular device that is resistant to leakage following a puncture with a needle and subsequent removal of the needle.
  • needle is used herein it is intended to include any object that can cause and/or maintain a puncture hole in the tubular device of the present invention, including without limitation: a pin; a sewing or suture needle; a hypodermic needle; a catheter device; a cannula device; a scalpel or knife; a thorn or other sharp, pointy object; et cetera.
  • the tubular device of the present invention is particularly intended for use as an implantable device, such as a vascular graft, that is capable of transferring body fluids.
  • an implantable device such as a vascular graft
  • the device of the present invention is especially useful as an AV access graft or the like.
  • Especially preferred is use of the device of the present invention to allow for
  • FIG. 1 and 2 illustrate one embodiment of a tubular device 10 of the present invention.
  • the device 10 comprises at least a first tube element 12 and a second element 14, preferably tubular, each mounted concentrically with one another and having an "interference fit,” with one another.
  • interference fit connotes a sufficiently tight contact between the tube elements, at least when the device 10 is installed in place and under normal operating pressures, so that a longitudinal stress applied to one of the tube elements will be maintained. For example, if the first tube element is stretched longitudinally (that is, has a positive stress applied along its length) and an interference fit is established with the second element, then the first tube element will retain at least some of its stretched orientation due to the tight fit between the first tube element and the second element. It should be evident that to whatever degree the first tube element may contract from its stretched dimensions in this example, the second element will then be compressed to that degree (that is, the second element will have a negative stress applied along its length).
  • the second element is tubular, providing a ready means for forming a snug fit between the first tube element and the second element.
  • the second element may alternatively comprise a strip or other configuration of material that is attached to the first tube element in such a way as to allow relative movement between the first tube element and the second element.
  • the interference fit employed with the present invention is preferably sufficiently tight to maintain a stress differential between the tube elements, as will become clear from the following description.
  • the interference fit between the tube elements should allow for the relative movement between the tube elements during and after a diagonal puncture.
  • At least two tube elements 12, 14 are employed and each of the elements 12, 14 should have a stress applied and maintained along its length, with the longitudinal stress applied to the first tube element 12 being different from the longitudinal stress applied to the second tube element 14.
  • the first tube element may have a positive stress applied along its length (that is, it is stretched longitudinally), with the second tube element having no stress (that is, it maintains its natural resting state of stress) or a negative stress applied along its length (that is, it is compressed longitudinally).
  • the second tube element may have a positive stress applied along its length, with the first tube element having no stress or a negative stress applied along its length.
  • the important aspect is that a stress differential is established between the tube elements so that they will each react differently when a puncture is applied through the device.
  • a vascular graft having a 7 mm final outer diameter and 5.8 mm final inner diameter can be constructed from two tubes of expanded polytetrafluoroethylene (PTFE), a first tube having an initial inner diameter of about 6 mm, an outer diameter of about 7.2 mm, a wall thickness of about 0.6 mm, and an initial length of about 30 cm, and a second tube having an initial inner diameter of about 6 mm, an initial outer diameter of about 6.9 mm, a wall thickness of about 0.45 mm, and an initial length of about 50 cm.
  • PTFE expanded polytetrafluoroethylene
  • a longitudinal stress differential can be established between the two expanded PTFE tubes by applying a longitudinal tensile strain to the first tube, and applying a longitudinal compressive strain to the second tube to reduce its length to about 70% of its original length.
  • the first tube will slightly recover, with the second tube undergoing some degree of compression.
  • the first tube will have a tensile strain applied along its length of about 30% (that is, it is about 30% longer than its initial length) and the second tube will have a compressive strain applied along its length of about 60% (that is, it is about 60% of its initial length).
  • the degree of stretch or compression between the two tubes can be measured by the amount of change in distance between the pre-measured marks on the two tubes.
  • a first set of marks may be placed on a first tube 1 cm apart longitudinally and a second set of marks may be placed on a second tube 1 cm apart longitudinally.
  • the relative stresses applied to the tube elements may be measured by applying the same principles in reverse.
  • measured sets of marks may be placed on the inside and outside tubes of the complete device and then the device may be disassembled, relieving any stress differential on the tubes. Any change in the distance between the measured marks may then be measured to provide the degree of change.
  • a vascular graft having two tubes with an interference fit between them may have sets of 1 cm marks placed on both the inside tube and the outside tube.
  • stress differential between the tubes will be relieved, which will either lengthen or shorten the distance between the marks in each set.
  • a change of distance from 1 cm to about 1.67 cm on one of the tubes will indicate a degree of compression of about 60%.
  • this method one can readily determine whether a multiple layered tube has stress differentials between its various tube elements.
  • a stress differential can be confirmed by performing a simple puncture test on a device of the present invention. As is illustrated in Figures 5 through 9 and is explained in detail below, when a diagonal puncture is placed through the device 10 with a needle, a stress differential between the layers will cause the two layers of the device to move relative to each other when the needle is removed, creating a discontinuous hole through the device. Thus a stress differential between the tube elements can also be shown through this simple puncture test.
  • the present invention will also function by using materials with different moduli of elasticity for the first tube element and the second element. In this manner, each of the layers will react differently to a diagonal puncture, again causing a hole misalignment when the needle is removed.
  • a further refinement of the present invention employs materials with different moduli of elasticity and a stress differential applied to each of the layers. Other physical properties, such as differentials in thicknesses, density, materials, and other mechanical and physical properties may be incorporated into devices of the present invention to provide suitable performance.
  • An alternative embodiment of a device 10 of the present invention is illustrated in Figures 3 and 4. In this embodiment a first tube element 16 is employed that is longer in length than the second tube element 18.
  • the two tube elements 16, 18 should have an interference fit established between them and a stress differential between the two elements 16, 18.
  • the device of this embodiment is intended to address those instances where the device as a whole does not need to be cannulated, but only that segment corresponding to the length of the second tube element 18.
  • the stresses applied to each of the two tube elements 16, 18 may be positive, none, or negative, so long as a stress differential is established.
  • tensile stress refers to a longitudinal positive “pull” on the tube component; the term “compressive stress” refers to a negative compression of the tube component. Since the anchorage of this device will be through attachment of the first tube element 16 at its ends 20, 22, it is preferred to have a tensile stress applied along the first tube element 16.
  • a wall segment 24 of the device 10 is shown comprising an inner or first tube element 26 and an outer or second tube element 28.
  • the first tube element 26 is the one with a positive stress along its length.
  • a needle 30 is shown in Figures 5 through 7, in this instance a 15 gauge hypodermic needle having a cutting tip 32.
  • the needle 30 is oriented at a diagonal to the wall segment 24 (that is, it is positioned at an angle other than directly perpendicular to the wall segment). Normally a needle of this type will be introduced diagonally at an angle of about 15 to 60 degrees from perpendicular, with an angle of about 45 degrees from perpendicular illustrated.
  • Shown in Figure 6 is the needle 30 after it has penetrated the second tube element 28 forming a first opening 34.
  • Figure 7 illustrates the needle 30 after it has penetrated both the second tube element 28 and the first tube element 26 to form a second opening 38.
  • the first tube element 26 also undergoes relative movement, in this instance a downward distortion 40.
  • the present invention be constructed from materials suitable for implantation, and especially bio-compatible material or materials, such as polytetrafluoroethylene (PTFE), expanded PTFE, DACRON® polymer, polyurethane, silicone elastomer, and
  • a device constructed from expanded PTFE such as that disclosed in United States Patents 3,953,566, 3,962,153, 4,096,227, and 4,187,390, each incorporated by reference Tubes made in accordance with these patents adapted for use as a vascular graft are commercially available from W L Gore & Associates, Ine , Flagstaff, AZ, under the trademark GORE-TEX®
  • a device of the present invention can be constructed by combining commercially available vascular grafts in the following manner
  • a Stretch GORE-TEX® Vascular Graft may be used as a base graft
  • These stretch grafts are available from W L Gore & Associates, Ine , in a variety of internal diameters (ranging from about 5 to 10 cm) and a nominal wall thickness of about 0 6 mm
  • the base graft is placed onto an assembly mandrel and secured at one end
  • a load is placed on the opposite end to apply tension to the graft
  • a second GORE-TEX® vascular graft may be used as the outer graft, preferably one having a relatively thin wall Thin wall vascular grafts are available from W L Gore & Associates, Ine , in a variety of internal diameters (ranging from about 3 to 10 cm) and a nominal wall thickness of about 0 45 mm
  • the second vascular graft should be sized to be approximately the same internal diameter as that of the base graft, thus forming an interference fit when the two grafts are combined together
  • the second vascular graft is pulled over the base graft and the assembly mandrel, creating an interference fit between the two grafts.
  • the outer graft is then longitudinally compressed along its length.
  • the outer graft may be compressed from about 50 to 70 % of its original length, with a compression of about 60% being most preferred. This provides longitudinal compression in the outer graft.
  • the combined grafts are then removed from the assembly mandrel. In use, longitudinal forces applied to the graft will be applied to the base graft so that the outer graft will remain in compression.
  • two, three, or more grafts may be combined in this manner, with compression or tension applied to one or more of the layers to support relative movement between the graft layers during and after a puncture.
  • the present invention solves many of the prior deficiencies with leak-resistant tubular devices.
  • the combination of discontinuous openings through the device wall and the negative stress on one of the tube elements, causing the tube to "close up,” combine to provide a device that is very resistant to leakage.
  • the device can be constructed from very few components and in dimensions that are similar to those of conventional single wall tubes. As a result, the device of the present invention is very compact and requires little or no additional space for use over more conventional vascular grafts and similar products.
  • the device of the present invention can be constructed substantially or even entirely from highly bio-compatible material, such as PTFE, without the need to introduce elastomers or other products that might cause compatibility problems or other complications.
  • one of the tube elements is corrugated. Puncturing a corrugated tubular element causes a flap to form at the puncture point. The flap also helps reduce leaking by either filling the hole in the non-corrugated tube element or by covering the slit hole left in the corrugated tube element. This advantage combined with hole misalignment creates a tube that is very resistant to leakage after puncture.
  • the device of the present invention can be constructed from a wide variety of materials and in a variety of different constructions.
  • Figures 10 and 11 illustrate a two-layer construction of a leak-resistant tube 42 of the present invention.
  • a continuous base tube 44 is covered with an outer layer of a helically wound tape 46, thus creating the outer tubular element 48.
  • the outer tubular element 48 will retain the differential stress within the device 42.
  • This leak-resistant tube 50 employs three tube elements 52, 54, and 56 connected together with an interference fit.
  • Base tube 52 is surrounded by an intermediate tube 54 that is further covered by an outer tube 56.
  • Tension, compression, or no stress may be applied to one or more of these tube elements to impart a differential stress to the device as a whole. It should be evident that this embodiment allows for even greater misalignment of holes through the device upon removal of a puncture since stresses can be imparted to the device to move each of the layers in different directions during and after a diagonal puncture.
  • Figures 14 and 15 illustrate a further embodiment of a vascular graft 58 of the present invention.
  • a first tube element 60 is partially covered with a second element 62 comprising a strip of material.
  • the second element 62 is anchored to the first tube element 60 on the second element's ends 64a, 64b and perhaps along its longitudinal sides 66a, 66b.
  • the operative piercing surface 68 of the second element 62 should be free to move relative to the first tube element 60 in order to provide the hole misalignment previously described.
  • Anchorage between the first tube element 60 and the second element 62 may be accomplished through a variety of means.
  • thin strips of adhesive may be applied near the ends 64a, 64b of the device to anchor the ends in place.
  • Suitable adhesives include fluorinated ethylene propylene (FEP), Silicone, etc.
  • Adhesive may also be applied along the sides 66a, 66b.
  • Other anchorage means that may be employed with this embodiment include sutures, staples, clips, etc.
  • a stress differential is applied between the first tube element 60 and the second element 62. This can be accomplished by stretching or compressing the second element 62 before attaching it to the first tube element 60. Alternatively or additionally, the first tube element 60 may be stretched or compressed prior to attachment to establish a stress differential. Again, the second element 62 may be made with materials having different mechanical and physical properties to provide suitable performance.
  • This device of the present invention has particular application as a vascular graft, and particularly as an A-V shunt for use in dialysis treatments.
  • Figure 16 shows a graft 74 of the present invention implanted into a human arm. Vascular graft 74 is attached between vein 70 and artery 72.
  • Figures 17 and 18 illustrate another embodiment of the present invention.
  • a first tube element 80 is stretched longitudinally such that it is under tension (that is, has a positive stress along its length) and a second element 82 is attached over the first tube element 80 with an interference fit between the first and second tube elements.
  • the second element 82 is compressed longitudinally such that is under compression (that is has a negative stress along its length) to 50 to 70 % of the original length, preferably 55 to 65%.
  • a strip of adhesive 84 is disposed longitudinally along the first tube element 80. The strip of adhesive assists in holding the first tube element 80 to the second tube element 82, helping to maintain proper differential stress on the tubes even when being handled.
  • the second tubular element may be provided with a plurality of partially circumferential slits 88 located at predetermined intervals along the longitudinal axis of the second tube element. These slits act as stress concentrations so that sections of the outer covering can be easily removed by tugging on the covering at the ends of the graft. This will "disconnect" a section of the graft loose for easy removal.
  • slits provide a means where a portion of the second tube element can be easily removed from first tube element at the ends of the device after cutting the device to length.
  • the slits may be positioned at regular intervals or at other desirable locations along the length of the tube.
  • the slits may be positioned at regular intervals or at other desirable locations along the length of the tube.
  • Figure 20 illustrates a pair of tweezers 89 removing a portion of the second tube element by "disconnecting" the covering.
  • Commercially available grafts provide a tubular structure that can easily be cut to length, providing for easily customizable lengths and end configurations. With a portion of the second tube element removed, the ends of the device comprises a first tube element which is similar to commercially available vascular grafts and can be cut and sewn to the host vessel using established techniques.
  • Figure 21 illustrates a further preferred embodiment of the present invention.
  • a first tube element 110 is stretched longitudinally such that it is under tension (that is, has a positive stress along its length).
  • the second element 112 comprises a corrugated tubular film that forms an interference fit with the first tube element 110.
  • the second element 112 is a tubular film compressed longitudinally such that it is under compression and forms a corrugated surface.
  • the corrugations of the second element 112 provide large convoluted spaces 114 for tissue incorporation and attachment.
  • the corrugated second element 112 also provides further improved sealing properties for the device.
  • the differential stress between the corrugated tubular film second element 112 and the first tube element 110 creates a misalignment 122 between the second element 112 and the first tube element 110 after puncture of the device 100.
  • Hole 118 in the first tube element 110 moves relative to slit hole 120 in the corrugated second element 112, creating a misalignment 122.
  • the tubular film may be made from a variety of materials, but is preferably an expanded ePTFE film.
  • the film can be uniaxially or biaxially expanded. Expansion of the film provides strength oriented in the direction of expansion.
  • the film is from about 0.0005 inch (0.013 mm) to about 0.002 inch (0.05 mm) thick.
  • One manner of producing a suitable film is as follows. A tube is made by wrapping a mandrel with multiple layers of film then sintering the film at 380° C for several minutes. After sintering, the film tube is removed from the mandrel.
  • a film tube provides several advantages. The second tube element must withstand the radial forces from the interference fit and from the fluid pressure in the graft. An oriented film has more strength and is less compliant in the direction of orientation.
  • Wrapping a film around a mandrel to form a film tube forms a tube with more radial strength and resistance to radial dilatation than an uno ented tube of the same mass, such as an extruded tube. Since the direction of orientation is placed in the orientation needed to achieve low leak performance, a film tube may provide the necessary mechanical properties with less mass than an unoriented extruded tube. Reduced mass is very desirable in an implantable medical device. Further, the reduced mass and orientation allows the tube to become corrugated when compressed perpendicular to the axis of orientation. These corrugations allow a sealing flap to form and provide areas for tissue attachment and ingrowth.
  • a preferred embodiment of the present invention utilizes a 1 inch
  • the film can be made according to Example 2 of United States Patent 5,814,405 to Branca et al., incorporated by reference.
  • the film has a nominal thickness of 0.0125 mm and a density of approximately 0.2 gm/cc.
  • About 25 layers of film are wound unto a 6.5 mm mandrel.
  • the film is sintered at 380° C for about 9 minutes. Once the mandrel has cooled, the film tube is removed from the mandrel.
  • this embodiment has the additional advantage of providing extra material in the device wall that will form a sealing flap following puncture.
  • the sealing flap will form either a hole filling flap or a slit hole covering flap once a puncturing needle is withdrawn from the device. This sealing flap helps to reduce the amount and time of leakage after cannulation.
  • Figures 22b - 22d show a cross section of the most corrugated device described above.
  • Figure 22b illustrates an enlarged section of the wall of the device shown in Figure 22a.
  • Figure 22c the device has been punctured and the needle removed.
  • a misalignment 122 has been created by the differential stress between the two tubular elements 110,112.
  • a flap 124 formed after puncture of the corrugated tubular film 112, is left that may partially fill the hole 118 left after the puncture of the first element 110. If the flap 124 does not fill the hole 118, it may cover the slit 120 in the corrugated tubular film 112, as is shown in Figure 22d.
  • the flap's ability to fill the hole in the first tube element or to cover the slit in the second tube element helps decrease leakage amounts and time by further obstructing the path for any leakage.
  • Figure 22e illustrates a similar construction of a low-leakage graft 100 of the present invention.
  • the first tube element 110 and the second tube element 112 have been reversed so as to created a corrugated inner surface.
  • the second element 112 comprises a corrugated tubular film that forms an interference fit with the first tube element 110.
  • the second element 112 is a tubular film compressed longitudinally such that it is under compression and forms a corrugated surface. This construction can be accomplished by corrugating the second tube element 1 12 once it is mounted within the first tube element 110.
  • the second tube element 112 may be corrugated on the outside of the first tube element 110 in the manner described below, and then the device may be turned inside out to achieve the final configuration.
  • the corrugated tubular film may be provided with a plurality of partially circumferential slits 130 located at regular intervals along the longitudinal axis of the corrugated tubular film 112. These slits act as stress concentrations so that sections of the outer covering can be easily removed by disconnecting the covering at the ends of the graft.
  • Figures 23a-d illustrate a pair of tweezers 132 removing a portion 133 of the corrugated tubular second element 112 by grasping and then "disconnecting" the covering.
  • Figure 24 illustrates a basic method of creating the corrugations of the corrugated tubular film of second element 112.
  • a thin tubular film is placed over the first tubular element 110 and anchored at end 115.
  • the thin tubular film is then compressed longitudinally towards end 115 in small increments to create corrugations.
  • An upper belt unit 140 includes two rolls 144a, 144b and a belt 142a around the two rolls.
  • Lower belt unit 141 also includes two rolls 144c, 144d and a belt 142b around the two rolls.
  • First tube element 110 is placed and secured onto a mandrel 156.
  • the thin tubular film 111 is placed over the first tube element 110 and secured at end 115.
  • Both the upper and lower belt units 140, 141 move along the longitudinal axis of the mandrel 156 in direction 150. The rolls rotate to create belt speed 148.
  • Both upper and lower belt units 140, 141 are synchronized to operate at the speed and apply the same force. They may be either mechanically or electronically synchronized.
  • the belt speed 148 is set higher than the speed the belt units move in direction 150. This difference overfeeds the thin tubular film 111 onto the first tubular element 110, creating a corrugated second element 112, as shown.
  • the preferred corrugated second element of the present invention has approximately 20 to 60 convoluted folds per centimeter.
  • Each fold 114 is preferably approximately 0.1 to 0.6 mm in depth.
  • corrugated is used therein it is intended to define one or more elements of a device that has multiple folds or ripples along its surface visible without magnification. These folds or ripples comprise excess material that may aid in sealing punctures formed through the devices in the manner described herein.
  • the second element may also be constructed in a variety of other shapes and sizes. Examples of other configurations include: square, circular, rectangular, or other shaped patches. Additionally, the second element may be combined in multiple layers and/or in multiple configurations to provide specific properties to the final device.
  • the term "interference fit" is intended to define a snug connection between the first tube element and the second element so that the elements can retain differential stresses established between them.
  • a leak-resistant vascular graft of the present invention may be made in the following manner.
  • a commercially available expanded PTFE 6 mm Stretch GORE-TEX® Vascular Graft is used as the base tube (first element). This tube has a nominal internal diameter of 6 mm and a nominal wall thickness of 0.60 mm.
  • the first element is placed onto an assembly mandrel and secured at one end.
  • a load is placed on the opposite end to apply tension to the first element.
  • a thin wall 6 mm expanded PTFE GORE-TEX® graft is used for the outer second element. It has nominal internal diameter of 6 mm and a nominal wall thickness of 0.45 mm. It is pulled over the first element and the assembly mandrel to create an interference fit between the two tubes. The outer second element is then compressed uniformly along its length to about 60% of its original length. This provides longitudinal compression in the outer second graft. The tubes are then removed from the assembly mandrel. In use, longitudinal forces applied to the composite tube will be applied to the first element so that the outer second element will remain in compression.
  • a 6 mm Stretch GORE-TEX® expanded PTFE Vascular Graft is used for the inner first element.
  • This graft has a nominal internal diameter of 6 mm and a nominal wall thickness of 0.60 mm.
  • the first element is placed onto an assembly mandrel and secured at one end.
  • a load is placed on the opposite end to apply tension to the first element.
  • An ultra thin wall expanded PTFE 6 mm GORE-TEX® graft is used for the outer second element. It has nominal internal diameter of 6 mm and a nominal wall thickness of 0.25 mm. It is pulled over the first element and the assembly mandrel creates an interference fit between the two tubes.
  • the outer second element is then compressed uniformly along its length to about 60% of its original length. This provides longitudinal compression in the second element.
  • Figure 26 shows the misalignment between the hole in the first tube element and the slit hole in the second tube element.
  • Means can be provided to assure that the compression in the outer graft is not disturbed during handling and implantation and which still allows the grafts relative motion during cannulation to provide the low leak feature.
  • a strip of bio-compatible, adhesive material is placed between the grafts.
  • This material is used to bond the two grafts along a narrow strip that is located opposite the side that will be cannulated.
  • This material can be constructed from a number of possible materials, including fluorinated thermoplastics (such as, fluorinated ethylene propylene (FEP) or perfluoroalkoxy polymer (PFA)) as well as silicones or polyurethanes.
  • FEP fluorinated ethylene propylene
  • PFA perfluoroalkoxy polymer
  • An expanded PTFE 6 mm Stretch GORE-TEX® Vascular Graft is used as a base graft.
  • This graft has a nominal internal diameter of 6 mm and a nominal wall thickness of 0.60 mm.
  • a full length and 0.4 cm wide strip of FEP film is applied lengthwise along the graft.
  • the base graft is placed onto an assembly mandrel and secured at one end.
  • a load is placed on the opposite end to apply tension to the graft.
  • a thin wall 6 mm GORE-TEX® graft is used for the outer graft. It has nominal internal diameter of 6 mm and a nominal wall thickness of 0.45 mm. It is pulled over the base graft and the assembly mandrel, creating an interference fit between the two grafts.
  • the outer graft is then compressed uniformly along its length to about 60% of its original length. This provides longitudinal compression in the outer graft. Heat and pressure are applied along the outer graft on top of the FEP strip, bonding the two tubes together along a narrow strip opposite the side to be cannulated. The grafts are then removed from the assembly mandrel. Longitudinal forces applied to the graft will be applied to the base graft so that the outer graft will remain in compression. The two tubes are able to displace during cannulation along the cannulation side, but the compression of the outer tube is resistant to change during handling and implantation
  • Additional tubes of varying thickness, density and structural orientation can be combined to further maximize hole misalignment and/or hole healing effects, as is illustrated in Figures 12 and 13, as previously described.
  • a base tube of an expanded PTFE 6 mm Stretch GORE-TEX® Vascular Graft is positioned on a vacuum mandrel in a longitudinally relaxed state. Vacuum is applied to the mandrel, collapsing the outer diameter (OD) of the graft.
  • An ultra thin wall expanded PTFE 6 mm GORE-TEX® graft is positioned on top of the base graft in a fully distended condition.
  • a second ultra thin wall 6 mm GORE-TEX® graft is positioned over the first two grafts and compressed uniformly along its length to about 60% of its original length. The grafts are then removed from the vacuum mandrel.
  • the graft provides a middle layer that bears most of the axial loads, a neutrally loaded inner layer that is easily displaced relative to the other two layers by penetration forces, and an outer layer that is compressively loaded to provide a healing effect.
  • a commercially available expanded PTFE 6 mm Stretch GORE-TEX® Vascular Graft is used for the first tube element.
  • the first tube element is placed onto an assembly mandrel and secured at one end.
  • a load is placed on the opposite end to apply tension to the tube.
  • Film is made according to Example 2 of United States Patent 5,814,405 to Branca et al.
  • a film tube is made by winding 25 layers of a one inch (2.54 cm) wide, 0.0005 inch (0.013 mm) thick expanded PTFE film on a
  • the wound film is sintered at 380° C on the mandrel to form a tube.
  • the film tube is then pulled over the base graft and the assembly mandrel as the second tube element.
  • the film tube is then compressed uniformly along its length to about 60% of its original length. This provides longitudinal compression in the film tube.
  • This graft has a nominal internal diameter of 6 mm and a nominal wall thickness of 0.6 mm and provides an interference fit with resulting hole misalignment following puncture.
  • Figure 27 shows a close up view of the misalignment between the hole in the first tube element and the slit hole in the second tube element.
  • Figure 28 shows the flap of the second tube element.
  • Figure 29 shows the flap of the second tube element partially filling the hole of the first tube element.
  • Figure 30 shows the misalignment between the hole in the first tube element and the slit hole in the second tube element.
  • An adjustable length leak resistant vascular graft of the present invention may be made in the following manner.
  • a commercially available 6 mm Stretch GORE-TEX® expanded PTFE Vascular Graft is used for the first tube element.
  • This graft has a nominal internal diameter of 6 mm and a nominal wall thickness of 0.6 mm.
  • a full length and 0.4 cm wide strip of FEP film is applied lengthwise along the first tube element.
  • the first tube element is placed onto an assembly mandrel and secured at one end.
  • a load is placed on the opposite end to apply tension to the tube.
  • a film tube is made by winding 25 layers of a 1 inch (2.54 cm) wide, 0.0005 (0.013 mm) thick expanded film made according to Example 2 of United States Patent 5,814,405 to Branca et al., incorporated by reference on a 6.5 mm mandrel.
  • the wound film is sintered at 380° C on the mandrel to form a tube for the second tube element.
  • Slits are cut into the film tube to provide a means for quick and easy removal of a short sections of the film tube after the graft has been cut to length in use.
  • the slits are 1/4 to 1/3 of the tube circumference in length.
  • Multiple slits are made, evenly spaced along the length of the tube.
  • the slits in the film tube are oriented such that the mid-point of the slit is aligned with the FEP strip on the base graft.
  • the film tube is pulled over the first tube element and the assembly mandrel to create an interference fit between the first tube and the film tube.
  • the film tube is then compressed uniformly along its length to about 60% of its original length, resulting in compression in the film tube and a corrugated surface on the film tube.
  • Heat and pressure are applied along the film tube on top of the FEP strip, bonding the two tubes together along a narrow strip opposite the side to be cannulated.
  • the film tube covered graft is then removed from the assembly mandrel. Any longitudinal forces applied to the graft will be taken by the base graft so that the outer film tube will remain in compression.
  • the film tube is able to displace during cannulation along the cannulation side, but the compression of the film tube is resistant to change during handling and implantation.
  • the graft may be made easier to handle by placing the completed graft on 6 mm mandrel, fully compressing the graft longitudinally and the heating the graft to 120° C for 1 hour.
  • the graft is removed from the mandrel and pulled out to finished length by applying a 500 gm load.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Pulmonology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un dispositif tubulaire destiné à transporter des liquides ou des gaz utilisant deux ou plusieurs éléments tubulaires (110, 112) montés de manière concentrique et adaptés pour se déplacer l'un par rapport à l'autre selon des perforations et le retrait du dispositif de perforation. Ce mouvement relatif crée une ouverture discontinue à travers le dispositif étanche. Un des éléments tubulaires peut en outre être ondulé et celui-ci constitue, une fois perforé, un rabat qui contribue à l'étanchéité du trou. Le dispositif, faisant l'objet de cette invention, est particulièrement utile comme dispositif implantable, notamment comme implant vasculaire.
PCT/US1999/002997 1999-02-10 1999-02-11 Tube etanche multicouches WO2000047271A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/US1999/002997 WO2000047271A1 (fr) 1999-02-11 1999-02-11 Tube etanche multicouches
AU32899/99A AU3289999A (en) 1999-02-10 1999-02-11 Multiple-layered leak-resistant tube

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US1999/002997 WO2000047271A1 (fr) 1999-02-11 1999-02-11 Tube etanche multicouches

Publications (1)

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WO2000047271A1 true WO2000047271A1 (fr) 2000-08-17

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Cited By (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002100454A1 (fr) * 2001-06-11 2002-12-19 Boston Scientific Limited Prothese composite eptfe/textile
WO2006008148A3 (fr) * 2004-07-21 2006-07-20 Aesculap Ag & Co Kg Prothese vasculaire textile a flexion longitudinale
US7560006B2 (en) 2001-06-11 2009-07-14 Boston Scientific Scimed, Inc. Pressure lamination method for forming composite ePTFE/textile and ePTFE/stent/textile prostheses
EP2316503A2 (fr) * 2000-06-23 2011-05-04 Terumo Kabushiki Kaisha Disque de soupape et dispositif de remplissage de combinaison utilisant le disque de soupape, tube, dispositif de raccordement de tuyaux, dispositif de fabrication de ports de connexion, et système de raccordement de tuyaux
EP2698126A1 (fr) * 2012-08-14 2014-02-19 Jong-Hoon Lee Stent et vaisseau artificiel doté de celui-ci
US9737422B2 (en) 2011-01-14 2017-08-22 W. L. Gore & Associates, Inc. Stent
WO2017184153A1 (fr) * 2016-04-21 2017-10-26 W. L. Gore & Associates, Inc. Endoprothèses diamétralement réglables, systèmes et procédés associés
US9931193B2 (en) 2012-11-13 2018-04-03 W. L. Gore & Associates, Inc. Elastic stent graft
US10022220B2 (en) 2000-04-06 2018-07-17 Edwards Lifesciences Corporation Methods of implanting minimally-invasive prosthetic heart valves
US10166128B2 (en) 2011-01-14 2019-01-01 W. L. Gore & Associates. Inc. Lattice
US10279084B2 (en) 2012-12-19 2019-05-07 W. L. Gore & Associates, Inc. Medical balloon devices and methods
US10842918B2 (en) 2013-12-05 2020-11-24 W.L. Gore & Associates, Inc. Length extensible implantable device and methods for making such devices
US11439502B2 (en) 2017-10-31 2022-09-13 W. L. Gore & Associates, Inc. Medical valve and leaflet promoting tissue ingrowth
US11471276B2 (en) 2014-09-15 2022-10-18 W. L. Gore & Associates, Inc. Prosthetic heart valve with retention elements
US11497601B2 (en) 2019-03-01 2022-11-15 W. L. Gore & Associates, Inc. Telescoping prosthetic valve with retention element
US11826248B2 (en) 2012-12-19 2023-11-28 Edwards Lifesciences Corporation Vertical coaptation zone in a planar portion of prosthetic heart valve leaflet
US11857412B2 (en) 2017-09-27 2024-01-02 Edwards Lifesciences Corporation Prosthetic valve with expandable frame and associated systems and methods
US11872122B2 (en) 2012-12-19 2024-01-16 Edwards Lifesciences Corporation Methods for improved prosthetic heart valve with leaflet shelving
US11896481B2 (en) 2012-12-19 2024-02-13 Edwards Lifesciences Corporation Truncated leaflet for prosthetic heart valves
US11950999B2 (en) 2012-07-25 2024-04-09 Edwards Lifesciences Corporation Everting transcatheter valve and methods
US11986387B2 (en) 2017-09-27 2024-05-21 Edwards Lifesciences Corporation Prosthetic valves with mechanically coupled leaflets

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Cited By (35)

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Publication number Priority date Publication date Assignee Title
US10022220B2 (en) 2000-04-06 2018-07-17 Edwards Lifesciences Corporation Methods of implanting minimally-invasive prosthetic heart valves
EP2316503A2 (fr) * 2000-06-23 2011-05-04 Terumo Kabushiki Kaisha Disque de soupape et dispositif de remplissage de combinaison utilisant le disque de soupape, tube, dispositif de raccordement de tuyaux, dispositif de fabrication de ports de connexion, et système de raccordement de tuyaux
EP2316503A3 (fr) * 2000-06-23 2011-08-24 Terumo Kabushiki Kaisha Disque de soupape et dispositif de remplissage de combinaison utilisant le disque de soupape, tube, dispositif de raccordement de tuyaux, dispositif de fabrication de ports de connexion, et systeme de raccordement de tuyaux
US7560006B2 (en) 2001-06-11 2009-07-14 Boston Scientific Scimed, Inc. Pressure lamination method for forming composite ePTFE/textile and ePTFE/stent/textile prostheses
WO2002100454A1 (fr) * 2001-06-11 2002-12-19 Boston Scientific Limited Prothese composite eptfe/textile
WO2006008148A3 (fr) * 2004-07-21 2006-07-20 Aesculap Ag & Co Kg Prothese vasculaire textile a flexion longitudinale
US8128683B2 (en) 2004-07-21 2012-03-06 Aesculap & Co. Kg Longitudinally flexible textile vascular prosthesis
US10335298B2 (en) 2011-01-14 2019-07-02 W. L. Gore & Associates, Inc. Stent
US10507124B2 (en) 2011-01-14 2019-12-17 W. L. Gore & Associates, Inc. Lattice
US9795496B2 (en) 2011-01-14 2017-10-24 W. L. Gore & Associates, Inc. Stent
US9839540B2 (en) 2011-01-14 2017-12-12 W. L. Gore & Associates, Inc. Stent
US9737422B2 (en) 2011-01-14 2017-08-22 W. L. Gore & Associates, Inc. Stent
US10835397B2 (en) 2011-01-14 2020-11-17 W.L. Gore & Associates, Inc. Lattice
US10166128B2 (en) 2011-01-14 2019-01-01 W. L. Gore & Associates. Inc. Lattice
US10828185B2 (en) 2011-01-14 2020-11-10 W. L. Gore & Associates, Inc. Lattice
US11523919B2 (en) 2011-01-14 2022-12-13 W. L. Gore & Associates, Inc. Stent
US11950999B2 (en) 2012-07-25 2024-04-09 Edwards Lifesciences Corporation Everting transcatheter valve and methods
EP2698126A1 (fr) * 2012-08-14 2014-02-19 Jong-Hoon Lee Stent et vaisseau artificiel doté de celui-ci
CN103584928A (zh) * 2012-08-14 2014-02-19 李宗勋 支架及包括上述支架的人造血管
US9931193B2 (en) 2012-11-13 2018-04-03 W. L. Gore & Associates, Inc. Elastic stent graft
US11116621B2 (en) 2012-11-13 2021-09-14 W. L. Gore & Associates, Inc. Elastic stent graft
US11357611B2 (en) 2012-11-13 2022-06-14 W. L. Gore & Associates, Inc. Elastic stent graft
US10279084B2 (en) 2012-12-19 2019-05-07 W. L. Gore & Associates, Inc. Medical balloon devices and methods
US11896481B2 (en) 2012-12-19 2024-02-13 Edwards Lifesciences Corporation Truncated leaflet for prosthetic heart valves
US11872122B2 (en) 2012-12-19 2024-01-16 Edwards Lifesciences Corporation Methods for improved prosthetic heart valve with leaflet shelving
US11826248B2 (en) 2012-12-19 2023-11-28 Edwards Lifesciences Corporation Vertical coaptation zone in a planar portion of prosthetic heart valve leaflet
US10842918B2 (en) 2013-12-05 2020-11-24 W.L. Gore & Associates, Inc. Length extensible implantable device and methods for making such devices
US11911537B2 (en) 2013-12-05 2024-02-27 W. L. Gore & Associates, Inc. Length extensible implantable device and methods for making such devices
US11471276B2 (en) 2014-09-15 2022-10-18 W. L. Gore & Associates, Inc. Prosthetic heart valve with retention elements
US11229512B2 (en) 2016-04-21 2022-01-25 W. L. Gore & Associates, Inc. Diametrically adjustable endoprostheses and associated systems and methods
WO2017184153A1 (fr) * 2016-04-21 2017-10-26 W. L. Gore & Associates, Inc. Endoprothèses diamétralement réglables, systèmes et procédés associés
US11857412B2 (en) 2017-09-27 2024-01-02 Edwards Lifesciences Corporation Prosthetic valve with expandable frame and associated systems and methods
US11986387B2 (en) 2017-09-27 2024-05-21 Edwards Lifesciences Corporation Prosthetic valves with mechanically coupled leaflets
US11439502B2 (en) 2017-10-31 2022-09-13 W. L. Gore & Associates, Inc. Medical valve and leaflet promoting tissue ingrowth
US11497601B2 (en) 2019-03-01 2022-11-15 W. L. Gore & Associates, Inc. Telescoping prosthetic valve with retention element

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