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WO2025235475A1 - Gaine expansible et introducteur - Google Patents

Gaine expansible et introducteur

Info

Publication number
WO2025235475A1
WO2025235475A1 PCT/US2025/027936 US2025027936W WO2025235475A1 WO 2025235475 A1 WO2025235475 A1 WO 2025235475A1 US 2025027936 W US2025027936 W US 2025027936W WO 2025235475 A1 WO2025235475 A1 WO 2025235475A1
Authority
WO
WIPO (PCT)
Prior art keywords
sheath
protective cover
introducer
expandable sheath
central lumen
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/027936
Other languages
English (en)
Inventor
Eyal GERMAN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Edwards Lifesciences Corp
Original Assignee
Edwards Lifesciences Corp
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 Edwards Lifesciences Corp filed Critical Edwards Lifesciences Corp
Publication of WO2025235475A1 publication Critical patent/WO2025235475A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • 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
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • 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
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M2025/0024—Expandable catheters or sheaths

Definitions

  • the present application is directed to an expandable sheath and introducer for use with catheter-based technologies for repairing and/or replacing heart valves, as well as for delivering an implant, such as a prosthetic valve to a heart via the patient’s vasculature.
  • Endovascular delivery catheter assemblies are used to implant prosthetic devices, such as a prosthetic valve, at locations inside the body that are not readily accessible by surgery or where access without invasive surgery is desirable.
  • prosthetic devices such as a prosthetic valve
  • aortic, mitral, tricuspid, and/or pulmonary prosthetic valves can be delivered to a treatment site using minimally invasive surgical techniques.
  • Percutaneous interventional medical procedures utilize the large blood vessels of the body to reach target destinations rather than surgically opening a target site.
  • diseases or states that can be treated via interventional methods including coronary blockages, valve replacements (TAVR) and brain aneurysms.
  • TAVR valve replacements
  • brain aneurysms These techniques involve using wires, catheters, balloons, electrodes and other thin devices to travel down the length of the blood vessels from the access site to the target site.
  • the devices have a proximal end which the clinician controls outside of the body and a distal end inside the body, which is responsible for treating the disease state.
  • Percutaneous interventional procedures offer several advantages over open surgical techniques. First, they require smaller incision sites, which reduces scarring and bleeding as well as infection risk.
  • Procedures are also less traumatic to the tissue, so recovery times are reduced. Finally, interventional techniques can usually be performed much faster, and with fewer clinicians participating in the procedure, so overall costs are lowered. In some cases, the need for anesthesia is also eliminated, further speeding up the recovery process and reducing risk.
  • a single procedure typically uses several different guidewires, catheters, and balloons to achieve the desired effect.
  • each tool is inserted and then removed from the access site sequentially.
  • a guidewire is used to track to the correct location within the body.
  • a balloon may be used to dilate a section of narrowed blood vessel.
  • an implant may be delivered to the target site. Because catheters are frequently inserted and removed, introducer sheaths are used to protect the local anatomy and simplify the procedure.
  • An introducer sheath can be used to safely introduce a delivery apparatus into a patient’s vasculature (for example, the femoral artery).
  • Introducer sheaths are conduits that seal onto the access site blood vessel to reduce bleeding and trauma to the vessel caused by catheters with rough edges.
  • An introducer sheath generally has an elongated sleeve that is inserted into the vasculature and a housing that contains one or more sealing valves that allow a delivery apparatus to be placed in fluid communication with the vasculature with minimal blood loss.
  • One method to reduce push forces through the blood vessel and minimize vessel trauma is to provide a sheath and introducer with as minimal diameter as possible.
  • very thin delivery sheaths present challenges of strength and durability. Thicker layered sheaths can be provided but they necessitate high push forces to advance the delivery device/implant through the sheath.
  • One method to reduce push forces through the blood vessel is to provide a sheath and introducer system with an atraumatic tip.
  • aspects of the present expandable sheath and introducer system can minimize trauma to the vessel and damage to the sheath and prosthetic device by reducing the push force through the vessel and the number of components and steps of the procedure. Aspects ensure that the blood vessel is not damaged during efforts to advance the expandable sheath to the delivery site by providing a protective introducer, that shields sheath tip during insertion to the body. Additionally, the introducer described herein can be inserted or removed from the central lumen of the sheath without expanding the sheath and/or the patient’s blood vessel.
  • Additional aspects of the present expandable sheath can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate a delivery system, followed by a return to the original diameter once the delivery system passes through.
  • Some aspects can comprise a sheath with a smaller profile than that of prior art introducer sheaths.
  • certain implementations can reduce the length of time a procedure takes, as well as reduce the risk of a longitudinal or radial vessel tear, or plaque dislodgement, because lower push force is required and only one sheath is used, rather than several different sizes of sheaths.
  • the present disclosure provides a sheath system for deploying a medical device is releasably coupled to an introducer.
  • This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter.
  • the basic configuration can preferably also be provided with any one or more of the features shown in the figures and/or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.
  • the introducer includes a protective cover that is configured to cover the distal end of the expandable sheath during insertion into the patient’s blood vessel.
  • the techniques described herein relate to an introducer for use with a medical device delivery system, the introducer including an elongated shaft.
  • the elongated shaft includes a main body portion, a tapered distal region, a reduced diameter portion having a diameter less than a diameter of the main body portion, and a protective cover extending radially from elongated shaft.
  • the protective cover is movable between a proximal orientation, where the protective cover extends towards a proximal end of the elongated shaft, and a distal orientation, where the protective cover extends towards a distal end of the elongated shaft.
  • the techniques described herein relate to an introducer, wherein the protective cover extends radially from the reduced diameter portion.
  • the techniques described herein relate to an introducer, wherein, in both the proximal orientation and the distal orientation, an axial length of the protective cover is less than or equal to an axial length of the reduced diameter portion, where the axial length of the reduced diameter portion is measured between the protective cover and a corresponding end of the reduced diameter portion. [0016] In some examples, the techniques described herein relate to an introducer, wherein the protective cover is biased in the proximal orientation.
  • the techniques described herein relate to an introducer, wherein, in the proximal orientation, at least a portion of the protective cover defines a curved profile extending from a first end of the protective cover toward a second end of the protective cover.
  • the techniques described herein relate to an introducer, wherein at least a portion of the protective cover is composed of a flexible material.
  • the techniques described herein relate to an introducer, wherein the reduced diameter portion includes a generally cylindrical main portion extending between the proximal end and the distal end.
  • the techniques described herein relate to an introducer, wherein the reduced diameter portion includes a leading surface extending between the distal end and the generally cylindrical main portion, and a trailing surface extending between the proximal end and the generally cylindrical main portion, wherein the leading surface and the trailing surface define a curved surface.
  • the techniques described herein relate to an introducer, wherein the main body portion defines a generally cylindrical shaped structure with a central lumen extending therethrough.
  • the techniques described herein relate to an introducer, wherein the tapered distal region includes a rounded distal end surface.
  • the techniques described herein relate to a sheath system for deploying a medical device including: an expandable sheath including a central lumen extending therethrough, at least a portion of the sheath is optionally configured to locally expand from an unexpanded configuration in the which the central lumen has a first diameter to an expanded configuration in which the central lumen has a second diameter that is larger than the first diameter, and then locally contract at least partially back to the unexpanded configuration; an introducer optionally sized and configured to be received within the central lumen of the expandable sheath, the introducer including: an elongated shaft including: a main body portion; a tapered distal region; and a reduced diameter portion having a diameter less than a diameter of the main body portion; and a protective cover extending radially from elongated shaft, the protective cover optionally movable between a proximal orientation, where the protective cover extends towards a proximal end of the elongated shaft, and
  • the techniques described herein relate to a sheath system, wherein the expandable sheath includes: a first polymeric layer; a braided layer radially outward of the first polymeric layer, the braided layer including a plurality of filaments braided together; a resilient elastic layer radially outward of the braided layer, the elastic layer being configured to apply radial force to the braided layer and the first polymeric layer; and a second polymeric layer radially outward of the elastic layer and bonded to the first polymeric layer such that the braided layer and the elastic layer are encapsulated between the first and second polymeric layers; wherein when a medical device is passed through the sheath, the diameter of the sheath expands from a first diameter to a second diameter around the medical device while the first and second polymeric layers resist axial elongation of the sheath such that a length of the sheath remains substantially constant; and wherein the sheath resiliently returns to the first diameter by radi
  • the techniques described herein relate to a sheath system, wherein the first and second polymeric layers include a plurality of longitudinally-extending folds when the sheath is at the first diameter.
  • the techniques described herein relate to a sheath system, wherein, as a medical device is passed through the sheath, the plurality of longitudinally-extending folds at least partially unfold to allow the sheath to radially expand.
  • the techniques described herein relate to a method of positioning an introducer with respect to an expandable sheath, the method including: providing an introducer including: an elongated shaft including: a main body portion; a tapered distal region; and a reduced diameter portion having a diameter less than a diameter of the main body portion; and a protective cover extending radially from elongated shaft, the protective cover movable between a proximal orientation, where the protective cover extends towards a proximal end of the elongated shaft, and a distal orientation, where the protective cover extends towards a distal end of the elongated shaft; advancing/inserting the introducer into/within a central lumen of an expandable sheath into a first position such that the protective cover is in the proximal orientation and located between an inner surface of the expandable sheath and the reduced diameter portion of the elongated shaft; advancing a distal end of the introducer through a distal opening of
  • the techniques described herein relate to a method, wherein, when the distal end of the introducer is advanced through the distal opening of the central lumen of the expandable sheath, and the protective cover is positioned outside the expandable sheath, the protective cover expands to an uncompressed shape where the protective cover is in a proximal orientation and a diameter of the protective cover is greater than a diameter of the expandable sheath.
  • the techniques described herein relate to a method, wherein moving the introducer from the second position to the third position causes the protective cover to change orientation such that the protective cover into the distal orientation.
  • the techniques described herein relate to a method, wherein, in the first position and the third position, the protective cover is located between an inner surface of the expandable sheath and the reduced diameter portion of the elongated shaft such that the expandable sheath does not expand radially at a location of the protective cover.
  • the techniques described herein relate to a method, further including: coupling the introducer to the expandable sheath when in the second position such that the axial and/or rotational position of the expandable sheath with respect to the introducer is fixed; and uncoupling the introducer from the expandable sheath before withdrawing the introducer within the central lumen of the expandable sheath to the third position.
  • the techniques described herein relate to a method of delivering a medical device into a blood vessel of a patient, the method including: providing an introducer including: an elongated shaft including: a main body portion; a tapered distal region; and a reduced diameter portion having a diameter less than a diameter of the main body portion; and a protective cover extending radially from elongated shaft, the protective cover movable between a proximal orientation, where the protective cover extends towards a proximal end of the elongated shaft, and a distal orientation, where the protective cover extends towards a distal end of the elongated shaft; advancing/inserting an introducer into/within a central lumen of an expandable sheath into a first position such that the protective cover is in the proximal orientation and located between an inner surface of the expandable sheath and the reduced diameter portion of the elongated shaft; advancing a distal end of the introducer through a distal
  • the techniques described herein relate to a method, further including: coupling the introducer to the expandable sheath when in the second position such that the axial and/or rotational position of the expandable sheath with respect to the introducer is fixed; and uncoupling the introducer from the expandable sheath before withdrawing the introducer within the central lumen of the expandable sheath to the third position.
  • the techniques described herein relate to a method, wherein advancing the medical device through the expandable sheath causes the expandable sheath to locally expand from an unexpanded configuration at a first diameter to an expanded configuration at a second, larger, diameter in response to an outwardly directed radial force exerted on the central lumen by the medical device, and then locally contract at least partially back to the unexpanded configuration as the medical moves within the central lumen.
  • the techniques described herein relate to a method, wherein the medical device is a prosthetic device mounted in a radially crimped state on a delivery apparatus, wherein advancing the prosthetic device through the central lumen of the expandable sheath includes advancing the delivery apparatus and the prosthetic device through central lumen of the expandable sheath and into a vasculature of the patient.
  • the techniques described herein relate to a method, wherein the prosthetic device includes a prosthetic heart valve and the method further includes implanting the prosthetic heart valve at a treatment site within the patient.
  • the techniques described herein relate to a method, wherein the prosthetic heart valve is mounted on a balloon catheter of the delivery apparatus as the prosthetic heart valve is advanced through the expandable sheath.
  • the techniques described herein relate to a method, wherein the expandable sheath is inserted into a femoral artery of the patient.
  • Fig. 1 illustrates an exemplary delivery apparatus for a cardiovascular prosthetic device.
  • Fig. 2 illustrates an exemplary introducer device assembly.
  • Fig. 3 illustrates a side view of an expandable sheath that can be used in combination with the introducer device assembly of Fig. 2.
  • Fig. 4 is a side cross-sectional view of a portion of the expandable sheath of Fig. 3.
  • Fig. 5 is a magnified view of a portion of the expandable sheath of Fig. 3.
  • Fig. 6A is a magnified view of a portion of the expandable sheath of Fig. 3 with the outer layer removed for purposes of illustration.
  • Fig. 6B is a magnified view of a portion of the braided layer of the sheath of Fig. 3.
  • Fig. 7 is a magnified view of a portion of the expandable sheath of Fig. 3 illustrating expansion of the sheath as a prosthetic device is advanced through the sheath.
  • Fig. 8 is a side view of an exemplary introducer.
  • Fig. 9 is a magnified side cross-sectional view of a portion of the introducer of Fig. 8.
  • Fig. 10 is a side view of the introducer of Fig. 8 being advanced into the expandable sheath.
  • Fig. 11 is a side view of the introducer of Fig. 8 being advanced within the expandable sheath.
  • Fig. 12 is a magnified side cross-sectional view of a portion of the introducer of Fig. 8 being advanced into the expandable sheath.
  • Fig. 13 is a magnified side cross-sectional view of a portion of the introducer of Fig. 8 being advanced within the expandable sheath.
  • Fig. 14 is a partial side view of the introducer of Fig. 8 and the expandable sheath.
  • Fig. 15 is a partial side view of the introducer of Fig. 8 and the expandable sheath.
  • Fig. 16 is a partial side view of the introducer of Fig. 8 and the expandable sheath.
  • Fig. 17 is a magnified side cross-sectional view of a portion of the introducer of Fig. 8 being advanced through the distal end of the expandable sheath.
  • Fig. 18 is a magnified side cross-sectional view of a portion of the introducer of Fig. 8 being advanced through the distal end of the expandable sheath.
  • Fig. 19 is a magnified side cross-sectional view of a portion of the introducer of Fig. 8 withdrawn to cover the distal end of the expandable sheath.
  • Fig. 20 is a partial side view of the introducer of Fig. 8 and the expandable sheath.
  • Fig. 21 is a partial side view of the introducer of Fig. 8 and the expandable sheath.
  • Fig. 22 is a magnified side cross-sectional view of a portion of the introducer of Fig. 8 being withdrawn within the expandable sheath.
  • Fig. 23 is a magnified side cross-sectional view of a portion of the introducer of Fig. 8 being withdrawn within the expandable sheath.
  • proximal and distal refer to regions of a sheath, catheter, or delivery assembly. “Proximal” means that region closest to handle of the device, while “distal” means that region farthest away from the handle of the device.
  • “Axially” or “axial” as used herein refers to a direction along the longitudinal axis of the sheath.
  • the expandable introducer sheaths and related componentry described herein can be used to deliver a prosthetic device through a patient’s vasculature to a procedure site within the body.
  • the sheath can be constructed to be highly expandable and collapsible in both the radial and axial directions. Disclosed aspects of the expandable sheath can minimize trauma to the vessel by reducing push forces required to advance the sheath through the blood vessel.
  • the disclosed introducer includes a protective cover that can shield and/or cover the distal end of the sheath, providing an atraumatic combined sheath and introducer system that reduces the risk of damage to the vessel wall during placement of the sheath.
  • the expandable sheath can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery system, followed by a return to the original diameter once the device passes through.
  • Various aspects of the sheath system structure provide for an expandable sheath and introducer that can be safely and predictably advanced through the patient’s blood vessel. This reduces the length of time a procedure takes, as well as reduces the risk of a longitudinal or radial vessel tear, and damage to the expandable sheath.
  • Example expandable introducer sheaths are disclosed, for example, in U.S. Patent No. 8,690,936, entitled “Expandable Sheath for Introducing an Endovascular Delivery Device into a Body,” U.S. Patent No. 8,790,387, entitled “Expandable Sheath for Introducing an Endovascular Delivery Device into a Body,” U.S. Patent No. 10,639,152, entitled “Expandable Sheath and Methods of Using the Same,” U.S. Patent No. 10,792,471, entitled “Expandable Sheath,” U.S. Patent No. Application No. 16/407,057, entitled “Expandable Sheath with Elastomeric Cross Sectional Portions,” U.S. Patent No.
  • PCT/US2021/058247 entitled “Self-Expanding, Two Component Sheath,” Application No. PCT/US2022/012785, entitled “Expandable Sheath,” U.S. Patent No. 11,051,939, entitled “Active Introducer Sheath System,” Application No. PCT/US2022/012684, entitled “Introducer with Sheath Tip Expander,” U.S. Application No. 17/078,556, entitled “Advanced Sheath Patterns,” Application No. PCT/US2021/025038, entitled “Low temperature hydrophilic adhesive for use in expandable sheath for introducing an endovascular delivery device into a body,” Application No.
  • FIG. 1 illustrates an exemplar ⁇ ' sheath 40 in use with a representative delivery apparatus 10, such as a prosthetic heart valve or other prosthetic implant, to a patient.
  • the delivery apparatus 10 illustrated can generally include a steerable guide catheter 14 and a balloon catheter 16 extending through the guide catheter 14.
  • a prosthetic device such as a prosthetic heart valve (prosthetic device 12) can be positioned on the distal end of the balloon catheter 16.
  • the guide catheter 14 and the balloon catheter 16 can be adapted to slide longitudinally relative to each other to facilitate delivery and positioning of a prosthetic heart valve (prosthetic device 12) at an implantation site in a patient’s body.
  • the sheath 40 is an elongated, expandable tube that can include a hemostasis valve at the proximal end of the sheath to stop blood leakage.
  • the guide catheter 14 includes a handle portion 18 and an elongated guide tube or shaft extending from the handle portion 18.
  • the prosthetic heart valve (prosthetic device 12) can be delivered into a patient’s body in a radially compressed configuration and radially expanded to a radially expanded configuration at the desired deployment site.
  • the prosthetic heart valve (prosthetic device 12) is a plastically expandable prosthetic valve that is delivered into the patient’s body in a radially compressed configuration on a balloon of the balloon catheter 16 (as shown in Fig. 1) and then radially expanded to a radially expanded configuration at the deployment site by inflating the balloon (or by actuating another type of expansion device of the delivery apparatus). Further details regarding a plastically expandable heart valve that can be implanted using the devices disclosed herein are disclosed in U.S. Publication No.
  • the prosthetic heart valve (prosthetic device 12) can be a self-expandable heart valve that is restrained in a radially compressed configuration by a sheath or other component of the delivery apparatus and self-expands to a radially expanded configuration when released by the sheath or other component of the delivery apparatus. Further details regarding a self-expandable heart valve that can be implanted using the devices disclosed herein are disclosed in U.S. Publication No. 2012/0239142, which is incorporated herein by reference.
  • the prosthetic heart valve (prosthetic device 12) can be a mechanically expandable heart valve that comprises a plurality of struts connected by hinges or pivot joints and is expandable from a radially compressed configuration to a radially expanded configuration by actuating an expansion mechanism that applies an expansion force to the prosthetic valve.
  • a mechanically expandable heart valve that can be implanted using the devices disclosed herein are disclosed in U.S. Publication No. 2018/0153689, which is incorporated herein by reference.
  • a prosthetic valve can incorporate two or more of the above-described technologies.
  • a self-expandable heart valve can be used in combination with an expansion device to assist expansion of the prosthetic heart valve.
  • Fig. 2 illustrates an example introducer device assembly 20.
  • the assembly 20 may include the sheath 40 and an introducer 100.
  • the introducer 100 may be positioned within a central lumen 50 (indicated in Fig. 4) of the sheath 40, as shown in Fig. 2.
  • An optional control housing 22 may be positioned at a proximal end of the assembly and may include a sheath hub 24 and an introducer hub 30.
  • the sheath hub 24 and introducer hub 30 may optionally couple together, as shown in Fig. 2.
  • the sheath 40 and introducer 100 are shown in an insertion configuration, for insertion together into the patient's vasculature. Upon insertion into the patient's vasculature, the introducer 100 may be withdrawn longitudinally from the sheath 40, leaving the sheath 40 within the patient's vasculature. Features of the sheath 40 and the introducer 100 individually are discussed below, as well as the operation of the sheath 40 and introducer 100 together. [0080]
  • the sheath 40 comprises an elongate body that may have a cylindrical shape.
  • the sheath 40 has a sheath distal end 45 and a sheath proximal end 44, and a length LI (see Fig.
  • the sheath 40 is configured to be inserted into a patient's vasculature.
  • the sheath 40 may optionally comprise an introducer sheath that is used to introduce a delivery apparatus into the patient's vasculature.
  • the vasculature may comprise the blood vessels of the patient's body which may include the femoral artery or other vessels of the patient's body.
  • the vasculature such as the femoral artery, may be narrow or stiff, and may be difficult to easily insert a delivery apparatus therein.
  • the delivery apparatus may be larger than the vasculature, or may be unwieldy to penetrate through the skin or vasculature of the patient to pass therethrough by itself.
  • the vasculature may be too fragile to receive the delivery apparatus without use of an introducer sheath.
  • the sheath 40 accordingly may optionally be inserted into the patient's vasculature prior to the delivery apparatus being introduced, to provide an entry way or guide path for the delivery apparatus 10 to introduce the delivery apparatus into the patient's vasculature. After the sheath 40 is inserted, the sheath 40 may remain positioned within and surrounded by the patient's vasculature. The delivery apparatus 10 may then be passed through the lumen of the sheath 40 for introduction into the patient's body. The sheath 40 may remain in the vasculature until a desired time to remove the sheath 40.
  • the sheath 40 may be inserted into the vasculature percutaneously or a portion of the patient's body may be surgically opened for the sheath 40 to access the vasculature.
  • the delivery apparatus 10 passes through the lumen of the sheath 40 to reach a desired position in the patient's body. As shown in Fig. 1, the delivery apparatus 10 may pass through an opening at the proximal end of the sheath 40 for passage through the lumen of the sheath 40 and the vasculature of the patient. For example, in some implementations, the delivery apparatus 10 passes through an opening at the proximal end of the sheath 40 provided at the control housing 22 shown in Fig. 2
  • the delivery apparatus 10 and the assemblies disclosed herein may be used in transcatheter aortic valve implantation (TAVI).
  • TAVI transcatheter aortic valve implantation
  • the delivery apparatus 10 and the systems disclosed herein may be utilized for transarterial access, including transfemoral access, to a patient's heart.
  • the sheath 40 may optionally include a strain relief portion 46 at the sheath proximal end 44.
  • the strain relief portion 46 may be sized larger than a proximate portion of the sheath 40 and may seal the entry point of the vasculature, to reduce the possibility of blood or other fluid being released between the exterior surface of the sheath 40 and the vasculature.
  • the strain relief portion 46 provides a transition between the larger diameter proximal opening of the sheath 40 and the smaller diameter distal portion/opening of the sheath 40 as the medical device and/or introducer 100 are inserted into the central lumen 42 of the sheath 40.
  • a seal 48 is optionally positioned along the length of the sheath 40 to further prevent blood or other fluid flow from passing around the sheath 40 toward and out of the proximal end 44 of the sheath 40.
  • Fig. 3 illustrates a side view of an exemplary expandable sheath 40 that can be used in the introducer device assembly of Fig. 2.
  • the sheath hub 24 is optionally positioned at the sheath proximal end 44.
  • the sheath hub 24 may optionally include an internal chamber for the delivery apparatus 10 to be passed through to be delivered to the patient's vasculature.
  • the sheath hub 24 may be configured to remain external to the patient's vasculature when the sheath 40 is inserted therein and may be configured to remain external to the patient's skin for a percutaneous implantation of the sheath 40.
  • the sheath hub 24 may be configured for a user (such as a surgeon) to grip to manipulate the sheath 40.
  • the sheath hub 24 may optionally comprise a cylindrical body and may include a coupler 29 for coupling to another housing or component of the system.
  • the sheath hub 24 may optionally include a fluid port 26 for passing fluid such as blood to or from the patient's vasculature.
  • Tubing 27 with a valve 28 may be coupled to the fluid port 26, for passing fluid through the fluid port 26 and for sealing flow of the fluid through the fluid port 26.
  • the introducer sheath 40 need not include a sheath hub 24.
  • the sheath 40 can be an integral part of a component of the delivery apparatus 10, such as the guide catheter.
  • the sheath can extend from the handle portion 18 of the guide catheter. Additional examples of introducer devices and expandable sheaths can be found in U.S. Patent No. 11,273,062, which is incorporated by reference in its entirety.
  • Figs. 4 and 5 illustrate a cross-sectional view and a side view, respectively, of a portion of the expandable sheath 40.
  • the sheath 40 can have a natural, unexpanded outer diameter DI.
  • the expandable sheath 40 may optionally include a plurality of co-axial layers extending along at least a portion of the length LI of the sheath (Fig. 3). For example, with reference to Fig.
  • the expandable sheath 40 can include a first layer/inner layer 52 (also referred to as an inner layer), a second layer/braided layer 54 disposed around and radially outward of the inner layer 52, a third layer/elastic layer 56 disposed around and radially outward of the braided layer 54, and a fourth layer/outer layer 58 (also referred to as an outer layer) disposed around and radially outward of the elastic layer 56.
  • the inner layer 52 can define the central lumen 50 extending along a central axis Cl.
  • the sheath 40 may optionally include the inner layer 52 without the outer layer 58, or the outer layer 58 without the inner layer 52, depending upon the particular characteristics desired.
  • the inner layer 52 and/or the outer layer 58 can form longitudinally-extending folds or creases such that the surface of the sheath comprises a plurality of ridges 62 (also referred to herein as “folds”).
  • the ridges 62 can be circumferentially spaced apart from each other by longitudinally- extending valleys 64.
  • the ridges 62 and the valleys 64 can level out or be taken up as the surface radially expands and the circumference increases, as further described below.
  • the ridges 62 and valleys 64 can reform.
  • the inner layer 52 and/or the outer layer 58 can comprise a relatively thin layer of polymeric material.
  • the thickness of the inner layer 52 can be from 0.01 mm to 0.5 mm, 0.02 mm to 0.4 mm, or 0.03 mm to 0.25 mm.
  • the thickness of the outer layer 58 can be from 0.01 mm to 0.5 mm, 0.02 mm to 0.4 mm, or 0.03 mm to 0.25 mm.
  • the inner layer 52 and/or the outer layer 58 can comprise a lubricious, low-friction, and/or relatively non-elastic material.
  • the inner layer 52 and/or the outer layer 58 can comprise a polymeric material having a modulus of elasticity of 400 MPa or greater.
  • Exemplary materials can include ultra-high-molecular-weight polyethylene (UHMWPE) (for example, Dyneema®), high-molecular-weight polyethylene (HMWPE), or polyether ether ketone (PEEK).
  • UHMWPE ultra-high-molecular-weight polyethylene
  • HMWPE high-molecular-weight polyethylene
  • PEEK polyether ether ketone
  • Suitable materials for the inner and outer layers can include polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), ethylene tetrafluoroethylene (ETFE), nylon, polyethylene, poly ether block amide (for example, Pebax), and/or combinations of any of the above.
  • a sheath 40 can include a lubricious liner on the inner surface of the inner layer 52.
  • suitable lubricious liners include materials that can further reduce the coefficient of friction of the inner layer 52, such as PTFE, polyethylene, polyvinylidene fluoride, and combinations thereof.
  • Suitable materials for a lubricious liner also include other materials desirably having a coefficient of friction of 0.1 or less.
  • the sheath 40 can include an optional exterior hydrophilic coating on the outer surface of the outer layer 58.
  • a hydrophilic coating can facilitate insertion of the sheath 40 into a patient’s vessel, reducing potential damage.
  • suitable hydrophilic coatings include the HarmonyTM Advanced Lubricity Coatings and other Advanced Hydrophilic Coatings available from SurModics, Inc., Eden Prairie, MN. DSM medical coatings (available from Koninklijke DSM N.V, Heerlen, the Netherlands), as well as other hydrophilic coatings (for example, PTFE, polyethylene, polyvinylidene fluoride), are also suitable for use with the sheath 40.
  • hydrophilic coatings may also be optionally included on the inner surface of the inner layer 52 to reduce friction between the sheath and the delivery system, thereby facilitating the use and improving safety.
  • a hydrophobic coating such as Perylene, may be used on the outer surface of the outer layer 58 or the inner surface of the inner layer 52 in order to reduce friction.
  • the second layer/braided layer 54 can include a braided material.
  • Figs. 6 A and 6B illustrate the sheath 40 with the outer layer 58 removed to expose the elastic layer 56.
  • the braided layer 54 can comprise a plurality of members or filaments 60 (for example, metallic or synthetic wires or fibers) braided together.
  • the braided layer 54 can have any desired number of filaments 60, which can be oriented and braided together along any suitable number of axes. For example, with reference to Fig.
  • the filaments 60 can include a first set of filaments 60A oriented parallel to a first axis A, and a second set of filaments 60B oriented parallel to a second axis B.
  • the filaments 60A and 60B can be braided together in a biaxial braid such that filaments 60A oriented along axis A form an angle 0 with the filaments 60B oriented along axis B.
  • the angle 0 can be from 5° to 70°, 10° to 60°, 10° to 50°, or 10° to 45°. In the illustrated example, the angle 0 is 45°.
  • the filaments 60 can also be oriented along three axes and braided in a triaxial braid, or oriented along any number of axes and braided in any suitable braid pattern.
  • the braided layer 54 can extend along substantially the entire length LI of the sheath 40, or alternatively, can extend only along a portion of the length of the sheath.
  • the filaments 60 can be wires made from metal (for example, Nitinol, stainless steel, etc.), or any of various polymers or polymer composite materials, such as carbon fiber.
  • the filaments 60 can be round, and can have a diameter of from 0.01 mm to 0.5 mm, 0.03 mm to 0.4 mm, or 0.05 mm to 0.25 mm.
  • the filaments 60 can have a flat cross-section with dimensions of 0.01 mm x 0.01 mm to 0.5 mm x 0.5 mm, or 0.05 mm x 0.05 mm to 0.25 mm x 0.25 mm. In one example, filaments 60 having a flat crosssection can have dimensions of 0.1 mm x 0.2 mm. However, other geometries and sizes are also suitable for certain examples. If a braided wire is used, the braid density can be varied. Some examples have a braid density of from ten picks per inch to eighty picks per inch, and can include eight wires, sixteen wires, or up to fifty-two wires in various braid patterns. In some examples, the braided layer 54 can be laser cut from a tube, or laser-cut, stamped, punched, etc., from sheet stock and rolled into a tubular configuration. The braided layer 54 can also be woven or knitted, as desired.
  • the third layer/elastic layer 56 can be a resilient, elastic layer (also referred to as an elastic material layer).
  • the elastic layer 56 can be configured to apply force to the underlying inner layer 52 and braided layer 54 in a radial direction (for example, toward the central axis Cl of the sheath) when the sheath expands beyond its natural diameter by passage of the delivery apparatus through the sheath.
  • the elastic layer 56 can be configured to apply encircling pressure to the layers of the sheath beneath the elastic layer 56 to counteract expansion of the sheath. The radially inwardly directed force is sufficient to cause the sheath to collapse radially back to its unexpanded state after the delivery apparatus is passed through the sheath.
  • the elastic layer 56 can optionally comprise one or more members configured as strands, ribbons, or bands 66 helically wrapped around the braided layer 54.
  • the elastic layer 56 comprises two elastic bands 66A and 66B wrapped around the braided layer with opposite helicity, although the elastic layer may comprise any number of bands depending upon the desired characteristics.
  • the elastic bands 66A and 66B can be made from, for example, any of a variety of natural or synthetic elastomers, including silicone rubber, natural rubber, any of various thermoplastic elastomers, polyurethanes such as polyurethane siloxane copolymers, urethane, plasticized polyvinyl chloride (PVC), styrenic block copolymers, polyolefin elastomers, etc.
  • silicone rubber natural rubber
  • any of various thermoplastic elastomers polyurethanes such as polyurethane siloxane copolymers, urethane, plasticized polyvinyl chloride (PVC), styrenic block copolymers, polyolefin elastomers, etc.
  • the elastic layer can comprise an elastomeric material having a modulus of elasticity of 200 MPa or less.
  • the elastic layer 56 can comprise a material exhibiting an elongation to break of 200% or greater, or an elongation to break of 400% or greater.
  • the elastic layer 56 can also take other forms, such as a tubular layer comprising an elastomeric material, a mesh, a shrinkable polymer layer such as a heat-shrink tubing layer, etc.
  • the sheath 40 may also include an optional elastomeric or heat-shrink tubing layer around the outer layer 58.
  • the elastic layer 56 can also be radially outward of the polymeric outer layer 58.
  • one or both of the inner layer 52 and/or the outer layer 58 can be configured to resist axial shortening of the sheath 40 when the sheath expands radially. More particularly, one or both of the inner layer 52 and/or the outer layer 58 can resist stretching against longitudinal forces caused by friction between a prosthetic device and the inner surface of the sheath such that the length LI remains substantially constant as the sheath expands and contracts radially.
  • the term “substantially constant” means that the length LI of the sheath increases by not more than 1%, by not more than 5%, by not more than 10%, by not more than 15%, or by not more than 20%. Meanwhile, with reference to Fig.
  • the filaments 60A and 60B of the braided layer can be allowed to move angularly relative to each other such that the angle 0 changes as the sheath expands and contracts.
  • This in combination with the longitudinal ridges 62 (folds) in the inner layer 52 and outer layer 58, can allow the central lumen 50 to expand as a prosthetic device is advanced through it.
  • the inner layer 52 and the outer layer 58 can be heat-bonded during the manufacturing process such that the braided layer 54 and the elastic layer 56 are encapsulated between the inner layer 52 and the outer layer 58. More specifically, in certain examples, the inner layer 52 and the outer layer 58 can be adhered to each other through the spaces between the filaments 60 of the braided layer 54 and/or the spaces between the elastic bands 66. The inner layer 52 and outer layer 58 can also be bonded or adhered together at the proximal and/or distal ends of the sheath. In certain examples, the inner layer 52 and outer layer 58 are not adhered to the filaments 60.
  • the filaments 60 can move angularly relative to each other, and relative to the inner layer 52 and outer layer 58, allowing the diameter of the braided layer 54, and thereby the diameter of the sheath, to increase or decrease.
  • the length of the braided layer 54 can also change. For example, as the angle 0 increases, the braided layer 54 can foreshorten, and as the angle 0 decreases, the braided layer 54 can lengthen to the extent permitted by the areas where the inner layer 52 and outer layer 58 are bonded.
  • Fig. 7 illustrates radial expansion of the sheath 40 as a prosthetic device 12 is passed through the sheath 40 in the direction of arrow 82 (for example, distally). As the prosthetic device 12 is advanced through the sheath 40, the sheath 40 can resiliently expand to a second diameter D2 that corresponds to a size or diameter of the prosthetic device 12.
  • the prosthetic device 12 can apply longitudinal force to the sheath 40 in the direction of motion by virtue of the frictional contact between the prosthetic device 12 and the inner surface of the sheath 40.
  • the inner layer 52 and/or the outer layer 58 can be optionally configured to resist axial elongation such that the length LI of the sheath 40 remains constant, or substantially constant. This can reduce or prevent the braided layer 54 from lengthening, and thereby constricting the central lumen 50.
  • the angle 0 between the filaments 60 A and 60B can increase as the sheath 40 expands to the second diameter D2 to accommodate the prosthetic device 12. This can cause the braided layer 54 to foreshorten.
  • the filaments 60 are not engaged or adhered to the inner layer 52 or outer layer 58, the shortening of the braided layer 54 attendant to an increase in the angle 0 does not affect the overall length LI of the sheath.
  • the inner layer 52 and outer layer 58 can expand to the second diameter D2 without rupturing, in spite of being relatively thin and relatively nonelastic.
  • the sheath 40 can resiliently expand from its natural diameter DI to a second diameter D2 that is larger than the diameter DI as a prosthetic device 12 is advanced through the sheath 40, without lengthening, and without constricting.
  • the force required to push the prosthetic device 12 through the sheath 40 is significantly reduced.
  • the radial expansion of the sheath 40 can be localized to the specific portion of the sheath 40 occupied by the prosthetic device 12.
  • the portion of the sheath 40 immediately proximal to the prosthetic device 12 can radially collapse back to the initial diameter DI under the influence of the elastic layer 56.
  • the inner layer 52 and outer layer 58 can also buckle as the circumference of the sheath 40 is reduced, causing the ridges 62 and the valleys 64 to reform. This can reduce the size of the sheath 40 required to introduce a prosthetic device 12 of a given size.
  • the temporary, localized nature of the expansion can reduce trauma to the blood vessel into which the sheath 40 is inserted, along with the surrounding tissue, because only the portion of the sheath 40 occupied by the prosthetic device 12 expands beyond the sheath’s natural diameter and the sheath 40 collapses back to the initial diameter once the device has passed. This limits the amount of tissue that must be stretched in order to introduce the prosthetic device 12, and the amount of time for which a given portion of the vessel must be dilated.
  • the expandable sheath 40 examples described herein can provide surprisingly superior performance relative to known introducer sheaths.
  • a sheath 40 configured as described herein to deliver a prosthetic device having a diameter that is two times larger, 2.5 times larger, or even three times larger than the natural outer diameter of the sheath 40.
  • a crimped prosthetic heart valve having a diameter of 7.2 mm was successfully advanced through a sheath 40 configured as described above and having a natural outer diameter of 3.7 mm. As the prosthetic valve was advanced through the sheath 40, the outer diameter of the portion of the sheath 40 occupied by the prosthetic valve increased to 8 mm.
  • a prosthetic device having a diameter more than two times the outer diameter of the sheath 40 through the sheath 40, during which the outer diameter of the sheath 40 resiliently increased by 216%.
  • a sheath 40 with an initial or natural outer diameter of 4.5 mm to 5 mm can be configured to expand to an outer diameter of 8 mm to 9 mm.
  • Fig. 8 illustrates a side view of an example introducer 100 that can be used with the introducer device assembly of Figs. 1-3.
  • the introducer 100 includes an elongated shaft 110 defining a main body portion 111.
  • the main body portion 111 optionally defines a generally cylindrical shaped structure with a central lumen 115 passing therethrough.
  • introducer 100 includes a tapered distal region 112 with a rounded distal end surface.
  • the elongated shaft 110 includes a reduced diameter portion 130 having a diameter less than a diameter of the main body portion 111.
  • the reduced diameter portion 130 includes a generally cylindrical main portion 133 extending between a proximal end 131 and a distal end 132 of the reduced diameter portion 130.
  • the 130 includes a leading surface 134 extending between the distal end 132 and the generally cylindrical main portion 133, and a trailing surface 135 extending between the proximal end
  • the introducer 100 includes a protective cover 200 that is configured to shield the sheath tip during insertion to the body/blood vessel.
  • Fig. 9 is a magnified cross-sectional view of the portion of the introducer 100 including the protective cover 200. As shown in Fig. 9, the protective cover 200 extends radially from reduced diameter portion 130 of the elongated shaft 110.
  • the protective cover 200 is movable between varying orientations that allow the protective cover 200 to shield the distal end 42 and/or distal opening 43 of the sheath 40 when it is received over the introducer 100, while also allowing the protective cover 200 to be recessed with respect to the outer diameter of the introducer 100 and not interfere with withdraw of the introducer 100 from the sheath 40.
  • the protective cover 200 is movable between a proximal orientation shown in Fig. 9, where the protective cover 200 extends towards the proximal end 113 of the elongated shaft 110, and a distal orientation shown in Fig. 23, where the protective cover 200 extends towards the distal end 114 of the elongated shaft 110.
  • the protective cover 200 is optionally based in/toward the proximal orientation shown in Fig. 9. As described in more detail herein, movement of the protective cover 200 between the proximal orientation and the distal orientation allows for the introducer 100 to be advanced and withdrawn within the central lumen of the sheath 40 without increasing push force needed advance or withdraw the introducer 100 through the central lumen of the sheath 40.
  • the protective cover 200 extends radially from the reduced diameter portion 130 of the elongated shaft 110.
  • the protective cover 200 is provided at the axial midpoint of the reduced diameter portion 130.
  • the axial length of the protective cover 200 is less than or equal to the corresponding axial length of the reduced diameter portion 130.
  • the axial length of the protective cover is measured between the first end 202 of the protective cover 200, where the protective cover 200 is coupled to the elongated shaft 110, and the second end 203, free end, of the protective cover 200.
  • the corresponding axial length of the reduced diameter portion 130 is measured along the elongated shaft 110 between the first end 202 of the protective cover 200 and a corresponding proximal end 131 or distal end 132 of the reduced diameter portion 130.
  • the axial length of the protective cover 200 is less than the axial length of the reduced diameter portion 130, when the introducer 100 is received within the central lumen of the sheath 40 the protective cover 200 is received within the space defined between the reduced diameter portion 130 and the inner surface of the sheath 40, preventing the protective cover 200 from radially expanding the sheath 40 as the introducer 100 is advanced/withdrawn therethrough.
  • the protective cover 200 is received within the space defined between the reduced diameter portion 130 and the inner surface of the sheath 40, potential friction and/or interference between the protective cover 200 and the sheath 40 is minimized and push force needed advance or withdraw the introducer 100 through the central lumen of the sheath 40 is not negatively impacted.
  • Figs. 10 and 11 illustrate the introducer 100 being advanced into the sheath 40 (in a distal direction as noted by arrow A).
  • the protective cover 200 moves radially inward toward the outer surface (reduced diameter portion 130) of the elongated shaft 110 of the introducer 100.
  • Figs. 12 and 13 show magnified cross-sectional views of the portion of the introducer 100 including the protective cover 200 as it is advanced into and within the central lumen 42 of the sheath 40.
  • the protective cover 200 moves radially inward toward the outer surface of the elongated shaft 110/reduced diameter portion 130.
  • the axial length (LI) of the protective cover 200 when outside of the sheath 40 and in the proximal orientation is less than the axial length (L3) of the reduced diameter portion 130, measured between the first end 202 of the protective cover 200 and the proximal end 131 of the reduced diameter portion 130.
  • the axial length (L2) of the protective cover 200 is less than the axial length (L3) of the reduced diameter portion 130, measured between the first end 202 of the protective cover 200 and the proximal end 131 of the reduced diameter portion 130.
  • the axial length (L4) of the protective cover 200 is less than the axial length (L5) of the reduced diameter portion 130, measured between the second end 203 protective cover 200 and the distal end 132 of the reduced diameter portion 130.
  • the length (LI, L2, L4) of the protective cover 200 ranges from 4 mm to 6 mm. In some examples, the length (LI, L2, L4) of the protective cover 200 is 5 mm.
  • At least a portion of the protective cover 200 optionally defines a curved profile portion 206 extending from the first end 202 of the protective cover 200 toward a second end 204 of the protective cover 200.
  • a portion 208 of the protective cover 200 optionally extends generally parallel to the outer surface of the elongated shaft 110 and/or the reduced diameter portion 130, the parallel portion 208 extending between the curved profile portion 206 and the second end 204 of the protective cover 200.
  • the protective cover 200 is optionally composed of a flexible material, which allows the protective cover 200 to move between the proximal and distal orientation.
  • the protective cover 200 is optionally made from the same material as the elongated shaft 110 of the introducer 100.
  • the protective cover 200 is optionally composed of different material coupled to the elongated shaft 110 of the introducer 100.
  • the protective cover 200 can be composed of flexible and/or elastic material coupled to the introducer 100. It is completed that the protective cover 200 can be coupled and/or formed with the introducer 100 by an overmolding process, a heat process, a chemical adhesive, a mechanical fastener, and/or any other suitable coupling mechanism.
  • a method of positioning an introducer 100 with respect to the expandable sheath 40 is disclosed. It is contemplated that the introducer 100 can be used with any example sheath 40 described herein.
  • the introducer 100 is sized and configured to be received and movable within the central lumen 42 of the expandable sheath 40.
  • the protective cover 200 moves between a first (delivery/loading) position (Figs. 11 and 13), a second (distal/covered) position (Figs. 16 and 19), and a third (withdrawal) position (Figs. 20 and 23).
  • FIGs. 10-13 illustrate the introducer 100 being advanced in a distal direction (arrow A) into and within the central lumen 42 of the sheath 40.
  • Figs. 11 and 13 show the introducer 100 in the first (delivery/loading) position, with the introducer 100 and protective cover 200 received within the central lumen 42 of the sheath 40 and the introducer 100 moving in a distal direction (arrow A).
  • the protective cover 200 is in the proximal orientation with the second end 203 of the protective cover 200 orientated toward the proximal end 113 of the introducer 100.
  • Figs. 10-13 illustrate the introducer 100 being advanced in a distal direction (arrow A) into and within the central lumen 42 of the sheath 40.
  • Figs. 11 and 13 show the introducer 100 in the first (delivery/loading) position, with the introducer 100 and protective cover 200 received within the central lumen 42 of the sheath 40 and the introducer 100 moving in a distal direction (arrow A).
  • the protective cover 200
  • the protective cover 200 remains in the proximal orientation and moves from its neutral/initial expanded configuration (Fig. 12) toward position closer to the outer surface of the elongated shaft 110/reduced diameter portion 130 (Fig. 13).
  • the protective cover 200 is positioned within the space formed between the reduced diameter portion 130 and the inner surface of the sheath 40.
  • the protective cover 200 is compressed between the inner surface of the expandable sheath 40 and the reduced diameter portion 130 of the elongated shaft 110.
  • the protective cover 200 is provided in the space between the reduced diameter portion 130 and the inner surface of the sheath 40, advancing the introducer 100 through the sheath 40 does not result in a corresponding expansion of the sheath 40, allowing for a combined sheath/introducer with a reduced profile.
  • the medical device, delivery apparatus, or other medical tool having a diameter larger than the outer diameter of the central lumen 42 is advanced through the central lumen 42 of the sheath 40, at least a portion of the sheath 40 is configured to locally expand from an unexpanded configuration in the which the central lumen 42 has a first diameter to an expanded configuration in which the central lumen 42 has a second diameter that is larger than the first diameter, and then locally contract at least partially back to the unexpanded configuration.
  • Fig. 14 illustrates the introducer 100 being advanced distally (arrow A) through the central lumen 42 of the sheath 40 such that the distal end 114 of the introducer 100 extends beyond and through the distal opening 43 of the central lumen 42 sheath 40.
  • Fig. 17 provides a corresponding cross-sectional view of the introducer 100 and sheath 40 showing the protective cover 200 in the proximal orientation, where the protective cover 200 is partially extending through the distal opening 43 of the sheath 40 and partially constrained by the central lumen 42 of the sheath 40.
  • FIG. 15 illustrates the introducer 100 advanced through the central lumen 42 of the sheath 40, such that the protective cover 200 of the introducer 100 is located beyond the distal opening 43 of the sheath 40.
  • Fig. 18 provides a corresponding cross-sectional view of the introducer 100 and the sheath 40 showing the protective cover 200 located beyond the distal opening 43 and outside of the sheath 40 in the proximal orientation.
  • the protective cover 200 expands radially while maintaining the proximal orientation.
  • the diameter of the protective cover 200 is greater than the diameter of the expandable sheath 40.
  • the diameter (DI) of the inner facing surface of the protective cover 200 is greater than the outer diameter (D2) of the expandable sheath 40. Because the diameter (DI) of the inner facing surface of the protective cover 200 is greater than the outer diameter (D2) of the sheath 40, the user is able to move the protective cover 200/introducer 100 to the second (covered) position without interference of the introducer 100 with the outer surface and/or distal opening 43 of the sheath 40. As a result, the user is able to position the protective cover 200 over the distal opening 43 of the sheath 40 without the protective cover 200 moving to a distal orientation.
  • the introducer 100 can be withdrawn (moved in a proximal direct as noted by arrow B) within the central lumen 42 of the sheath 40 such that the protective cover 200 is positioned covering the distal end 45/distal opening 43 of the sheath 40.
  • Fig. 16 illustrates the introducer 100 being withdrawn within the central lumen 42 into the second (covered) position where the protective cover 200 extends over and/or around the distal end 45 and distal opening 43 of the sheath 40.
  • Fig. 19 provides a corresponding cross-sectional view of the introducer 100 and sheath 40 showing the protective cover 200 in the proximal orientation. As provided in Figs.
  • the introducer 100 is in the second (covered) position where the protective cover 200 extends over and/or otherwise covers the distal end 45 and distal opening 43 of the sheath 40.
  • the introducer 100 With the introducer 100 in the second (covered) position, placement of the protective cover 200 over the distal opening 43 of the sheath 40 ensures that the step height between the introducer 100 and the sheath 40, including any gap between the sheath 40 and introducer 100, or thickness/height of the sheath 40 distal end 45 does not cause trauma to the vessel wall during insertion.
  • the introducer 100 is optionally coupled to the sheath 40 when in the second (covered) position such that the axial and/or rotational position of the sheath 40 with respect to the introducer 100 is fixed. Before removing the introducer 100 from the sheath 40, the introducer 100 is uncoupled from the sheath 40, allowing the introducer 100 to move freely within the central lumen 42 of the sheath 40.
  • Fig. 20 illustrates the introducer 100 being further withdrawn within the central lumen 42 toward the third (withdrawal) position
  • Fig. 22 provides a corresponding cross-sectional view of the introducer 100 and sheath 40 as positioned in Fig. 20
  • Fig. 21 illustrates the introducer 100 being further withdrawn within the central lumen 42 in the third (withdrawal) position.
  • FIG. 23 provides a corresponding cross-sectional view of the introducer 100 and sheath 40 as positioned in Fig. 21, wherein moving the introducer 100 from the second position to the third position causes the protective cover 200 to change orientation moving from the proximal orientation to the distal orientation.
  • the protective cover 200 when located inside the central lumen 42 of the sheath 40, the protective cover 200 is located between the inner surface of the expandable sheath 40 and the reduced diameter portion 130 of the elongated shaft 110.
  • the second end 203 of the protective cover 200 is orientated toward the distal end 114 of the introducer 100.
  • the protective cover 200 flips and/or folds when moving from the proximal orientation into the distal orientation.
  • the protective cover 200 bends and/or flexes as it moves between the proximal and distal orientations.
  • the protective cover 200 can bend and/or flex along the curved profile portion 206 as the protective cover 200 moves between the proximal and distal orientations.
  • the protective cover 200 is compressed between the elongated shaft 110 and the inner surface of the sheath 40.
  • the protective cover 200 when in the first (delivery/loading) position and the third (withdrawal) position, the protective cover 200 is compressed between the inner surface of the expandable sheath 40 and the reduced diameter portion 130 of the elongated shaft 110.
  • the protective cover 200 When the protective cover 200 is removed from the sheath 40 the protective cover 200 expands radially to an uncompressed shape. Because the protective cover 200 is recessed within the space between the reduced diameter portion 130 and the sheath 40, the sheath 40 does not expand radially at the location of the protective cover 200, allowing for a combined sheath 40/introducer 100 with a reduced profile.
  • a method of delivering a medical device into a blood vessel of a patient using the introducer 100 and sheath 40 described herein is disclosed.
  • the introducer 100 and sheath 40 as described herein is provided.
  • the distal end 114 of the introducer 100 is inserted into the proximal end of the sheath 40 and advanced into the central lumen 42 of the sheath 40 as shown in Figs. 11-13.
  • the introducer 100 is advanced within the central lumen 42 of the sheath 40 in a distal direction (arrow A) such that the introducer 100 is in the first (delivery /loading) position and the protective cover 200 is in the proximal orientation, as shown in Fig. 13.
  • the protective cover 200 In the first (delivery/loading) position, the protective cover 200 is located between the inner surface of the sheath 40 and the elongated shaft 110/proximal end 113 of the introducer 100. In some implementations, the protective cover 200 is compressed between the inner surface of the expandable sheath 40 and the reduced diameter portion 130 of the elongated shaft 110.
  • the introducer 100 is further advanced within the central lumen 42 of the sheath 40 such that the distal end 114 of the introducer 100 extends through the distal opening 43 of the central lumen 42 of the sheath 40 until the protective cover 200 is positioned outside the sheath 40/distal opening 43, as illustrated in Figs. 15 and 18.
  • the introducer 100 is then withdrawn, in a proximal direction (arrow B), within the central lumen 42 of the sheath 40 into the second (covered) position.
  • the protective cover 200 extends over and/or around the distal opening 43 and/or distal end 45 of the sheath 40, as illustrated in Figs. 16 and 19.
  • the introducer 100 is optionally coupled to the sheath 40.
  • the axial and/or rotational position of the expandable sheath 40 with respect to the introducer 100 is fixed.
  • the protective cover 200 With the protective cover 200 extending over, around and/or otherwise covering the distal end 45 and/or distal opening 43 of the sheath 40, the combined sheath 40 and introducer 100 is then inserted into the patient’s blood vessel and advanced to the treatment site.
  • the expandable sheath 40 is inserted into a femoral artery of the patient.
  • the protective cover 200 of the introducer 100 shields the distal end 45 and distal opening 43 of the expandable sheath 40 during insertion into/through the body/blood vessel, preventing the distal end 45 of the sheath 40 and introducer 100 from catching or otherwise damaging the vessel wall.
  • a guidewire is optionally positioned at the treatment site and the sheath 40 and introducer 100 are advanced over the guide wire.
  • the introducer 100 is then further withdrawn within the central lumen 42 of the sheath 40 to the third (withdrawal) position. Withdrawing the introducer 100 within the sheath 40 causes the protective cover 200 to move from the proximal orientation to the distal orientation, as illustrated in Figs. 21 and 23. In some implementations, in the distal orientation, the protective cover 200 is located between (for example, compressed between) the inner surface of the expandable sheath 40 and the reduced diameter portion 130 of the elongated shaft 110 of the introducer 100.
  • the introducer 100 can be removed (and inserted) from the sheath 40 without expanding the outer diameter of the sheath 40, and as a result the adjacent portion of the vessel wall. Accordingly, use of the introducer 100 described herein reduces the risk of damage and/or trauma to the blood vessel during both sheath 40 insertion and removal of the introducer 100.
  • the introducer 100 must be uncoupled from the sheath 40 before the introducer 100 can be withdrawn from/within the central lumen 42 of the sheath 40.
  • the introducer 100 is then fully withdrawn from the central lumen 42 of the sheath 40, and the medical device advanced into the proximal end of the central lumen 42 of the sheath 40. Accessing the treatment site may require creating an opening in the heart tissue (for example, foramen ovalis) of the patient.
  • a cutting instrument can be advanced through the sheath 40 to create an opening in the patient’s heart tissue.
  • the medical device for example an implant, is advanced through the central lumen 42 of the sheath 40 and beyond a distal opening 43 to the treatment site within the blood vessel and/or heart tissue.
  • advancing the medical device through the sheath 40 causes the sheath 40 to locally expand from an unexpanded configuration at a first diameter to an expanded configuration at a second, larger, diameter in response to an outwardly directed radial force exerted on the central lumen by the medical device, and then locally contract at least partially back to the unexpanded configuration as the medical moves within the central lumen 42.
  • the medical device With the distal end of the sheath 40 positioned at the treatment site, the medical device is deployed beyond distal opening 43 of the sheath 40 and delivered to the patient.
  • the medical device/implant is a prosthetic device mounted in a radially crimped state on a delivery apparatus, and advancing the prosthetic device through the central lumen 42 of the sheath 40 includes advancing the delivery apparatus and the prosthetic device through central lumen 42 of the sheath 40 and into a vasculature of the patient.
  • the prosthetic device comprises a prosthetic heart valve and the method further comprises implanting the prosthetic heart valve at a treatment site within the patient.
  • the prosthetic heart valve is mounted on a balloon catheter of the delivery apparatus as the prosthetic heart valve is advanced through the sheath 40.
  • EXAMPLE 1 An introducer for use with a medical device delivery system, the introducer comprising: an elongated shaft including: a main body portion; a tapered distal region; and a reduced diameter portion having a diameter less than a diameter of the main body portion; and a protective cover extending radially from elongated shaft, the protective cover movable between a proximal orientation, where the protective cover extends towards a proximal end of the elongated shaft, and a distal orientation, where the protective cover extends towards a distal end of the elongated shaft.
  • an axial length of the protective cover is less than or equal to an axial length of the reduced diameter portion, where the axial length of the reduced diameter portion is measured between the protective cover and a corresponding end of the reduced diameter portion.
  • EXAMPLE 4 The introducer according to any example herein, particularly examples 1-3, wherein the protective cover is biased in the proximal orientation.
  • EXAMPLE 5 The introducer according to any example herein, particularly examples 1-4, wherein, in the proximal orientation, at least a portion of the protective cover defines a curved profile extending from a first end of the protective cover toward a second end of the protective cover.
  • EXAMPLE 6 The introducer according to any example herein, particularly examples 1-5, wherein at least a portion of the protective cover is composed of a flexible material.
  • EXAMPLE 7 The introducer according to any example herein, particularly examples 1-6, wherein the reduced diameter portion includes a generally cylindrical main portion extending between the proximal end and the distal end.
  • EXAMPLE 8 The introducer according to any example herein, particularly example 7, wherein the reduced diameter portion includes a leading surface extending between the distal end and the generally cylindrical main portion, and a trailing surface extending between the proximal end and the generally cylindrical main portion, wherein the leading surface and the trailing surface define a curved surface.
  • EXAMPLE 9 The introducer according to any example herein, particularly examples 1-8, wherein the main body portion defines a generally cylindrical shaped structure with a central lumen extending therethrough.
  • EXAMPLE 10 The introducer according to any example herein, particularly examples 1-9, wherein the tapered distal region includes a rounded distal end surface.
  • EXAMPLE I L A sheath system for deploying a medical device comprising: an expandable sheath including a central lumen extending therethrough, at least a portion of the sheath is configured to locally expand from an unexpanded configuration in the which the central lumen has a first diameter to an expanded configuration in which the central lumen has a second diameter that is larger than the first diameter (for example, due to an outwardly directed radial force exerted on the central lumen of the expandable sheath by a medical device), and then locally contract at least partially back to the unexpanded configuration; an introducer sized and configured to be received within the central lumen of the expandable sheath, the introducer comprising: an elongated shaft including: a main body portion; a tapered distal region; and a reduced diameter portion having a diameter
  • EXAMPLE 12 The sheath system according to any example herein, particularly example 11, wherein the expandable sheath includes: a first polymeric layer; a braided layer radially outward of the first polymeric layer, the braided layer comprising a plurality of filaments braided together; a resilient elastic layer radially outward of the braided layer, the elastic layer being configured to apply radial force to the braided layer and the first polymeric layer; and a second polymeric layer radially outward of the elastic layer and bonded to the first polymeric layer such that the braided layer and the elastic layer are encapsulated between the first and second polymeric layers; wherein when a medical device is passed through the sheath, the diameter of the sheath expands from a first diameter to a second diameter around the medical device while the first and second polymeric layers resist axial elongation of the sheath such that a length of the sheath remains substantially constant; and wherein the sheath resiliently returns to the first diameter
  • EXAMPLE 13 The sheath system according to any example herein, particularly example 12, wherein the first and second polymeric layers comprise a plurality of longitudinally-extending folds when the sheath is at the first diameter.
  • EXAMPLE 14 The sheath system according to any example herein, particularly example 13, wherein, as a medical device is passed through the sheath, the plurality of longitudinally-extending folds at least partially unfold to allow the sheath to radially expand. [0147] EXAMPLE 15.
  • a method of positioning an introducer with respect to an expandable sheath comprising: providing an introducer comprising: an elongated shaft including: a main body portion; a tapered distal region; and a reduced diameter portion having a diameter less than a diameter of the main body portion; and a protective cover extending radially from elongated shaft, the protective cover movable between a proximal orientation, where the protective cover extends towards a proximal end of the elongated shaft, and a distal orientation, where the protective cover extends towards a distal end of the elongated shaft; advancing/inserting the introducer into/within a central lumen of an expandable sheath into a first (delivery /loading) position such that the protective cover is in the proximal orientation and located (for example, compressed) between an inner surface of the expandable sheath and the reduced diameter portion of the elongated shaft; advancing a distal end of the introducer through a distal opening of
  • EXAMPLE 16 The method according to any example herein, particularly example 15, wherein, when the distal end of the introducer is advanced through the distal opening of the central lumen of the expandable sheath, and the protective cover is positioned outside the expandable sheath, the protective cover expands to an uncompressed shape where the protective cover is in a proximal orientation and a diameter of the protective cover is greater than a diameter of the expandable sheath.
  • EXAMPLE 17 The method according to any example herein, particularly examples 15-16, wherein moving the introducer from the second position to the third position causes the protective cover to change orientation such that the protective cover into the distal orientation.
  • EXAMPLE 18 The method according to any example herein, particularly examples 15-17, wherein, in the first (delivery/loading) position and the third (withdrawal) position, the protective cover is located (for example, compressed) between an inner surface of the expandable sheath and the reduced diameter portion of the elongated shaft such that the expandable sheath does not expand radially at a location of the protective cover.
  • EXAMPLE 19 The method according to any example herein, particularly examples 15-18, further including: coupling the introducer to the expandable sheath when in the second (covered) position such that the axial and/or rotational position of the expandable sheath with respect to the introducer is fixed; and uncoupling the introducer from the expandable sheath before withdrawing the introducer within the central lumen of the expandable sheath to the third (withdrawal) position.
  • EXAMPLE 20 A method of delivering a medical device into a blood vessel of a patient, the method comprising: providing an introducer comprising: an elongated shaft including: a main body portion; a tapered distal region; and a reduced diameter portion having a diameter less than a diameter of the main body portion; and a protective cover extending radially from elongated shaft, the protective cover movable between a proximal orientation, where the protective cover extends towards a proximal end of the elongated shaft, and a distal orientation, where the protective cover extends towards a distal end of the elongated shaft; advancing/inserting an introducer into/within a central lumen of an expandable sheath into a first (delivery/loading) position such that the protective cover is in the proximal orientation and located (for example, compressed) between an inner surface of the expandable sheath and the reduced diameter portion of the elongated shaft; advancing a distal end
  • EXAMPLE 21 The method according to any example herein, particularly example 20, further including: coupling the introducer to the expandable sheath when in the second (covered) position such that the axial and/or rotational position of the expandable sheath with respect to the introducer is fixed; and uncoupling the introducer from the expandable sheath before withdrawing the introducer within the central lumen of the expandable sheath to the third (withdrawal) position.
  • EXAMPLE 22 The method according to any example herein, particularly examples
  • advancing the medical device through the expandable sheath causes the expandable sheath to locally expand from an unexpanded configuration at a first diameter to an expanded configuration at a second, larger, diameter in response to an outwardly directed radial force exerted on the central lumen by the medical device, and then locally contract at least partially back to the unexpanded configuration as the medical moves within the central lumen.
  • EXAMPLE 23 The method according to any example herein, particularly examples
  • EXAMPLE 24 The method according to any example herein, particularly example
  • the prosthetic device comprises a prosthetic heart valve and the method further comprises implanting the prosthetic heart valve at a treatment site within the patient.
  • EXAMPLE 25 The method according to any example herein, particularly example
  • the prosthetic heart valve is mounted on a balloon catheter of the delivery apparatus as the prosthetic heart valve is advanced through the expandable sheath.
  • EXAMPLE 26 The method according to any example herein, particularly examples 20-25, wherein the expandable sheath is inserted into a femoral artery of the patient.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Les gaines expansibles peuvent être utilisées conjointement avec un ensemble de cathéter pour introduire un dispositif prothétique, tel qu'une valve cardiaque, dans un patient. Les traumatismes causés au vaisseau peuvent être réduits au minimum en fournissant un introducteur configuré pour être reçu à l'intérieur de la gaine expansible. L'introducteur comprend une tige allongée ayant une portion de corps principal, une région distale effilée et une portion de diamètre réduit ayant un diamètre inférieur au diamètre de la portion de corps principal. L'introducteur comprend également un couvercle de protection s'étendant radialement à partir de la tige allongée, le couvercle de protection étant mobile entre une orientation proximale, dans laquelle le couvercle de protection s'étend vers une extrémité proximale de la tige allongée, et une orientation distale, dans laquelle le couvercle de protection s'étend vers une extrémité distale de la tige allongée. Lorsqu'il est utilisé avec une gaine expansible, le couvercle de protection peut être positionné pour recouvrir l'extrémité distale de la gaine expansible.
PCT/US2025/027936 2024-05-07 2025-05-06 Gaine expansible et introducteur Pending WO2025235475A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202463643816P 2024-05-07 2024-05-07
US63/643,816 2024-05-07

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WO2025235475A1 true WO2025235475A1 (fr) 2025-11-13

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US20120239142A1 (en) 2011-02-25 2012-09-20 Jun Liu Prosthetic heart valve delivery apparatus
US8690936B2 (en) 2008-10-10 2014-04-08 Edwards Lifesciences Corporation Expandable sheath for introducing an endovascular delivery device into a body
US8790387B2 (en) 2008-10-10 2014-07-29 Edwards Lifesciences Corporation Expandable sheath for introducing an endovascular delivery device into a body
US20180153689A1 (en) 2016-12-06 2018-06-07 Edwards Lifesciences Corporation Mechanically expanding heart valve and delivery apparatus therefor
US10327896B2 (en) 2015-04-10 2019-06-25 Edwards Lifesciences Corporation Expandable sheath with elastomeric cross sectional portions
US10639152B2 (en) 2017-06-21 2020-05-05 Edwards Lifesciences Corporation Expandable sheath and methods of using the same
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US11051939B2 (en) 2017-08-31 2021-07-06 Edwards Lifesciences Corporation Active introducer sheath system
US11273062B2 (en) 2018-04-09 2022-03-15 Edwards Lifesciences Corporation Expandable sheath
WO2022155577A1 (fr) * 2021-01-18 2022-07-21 Edwards Lifesciences Corporation Dilatateurs et gaines à caractéristiques d'expansion

Patent Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8690936B2 (en) 2008-10-10 2014-04-08 Edwards Lifesciences Corporation Expandable sheath for introducing an endovascular delivery device into a body
US8790387B2 (en) 2008-10-10 2014-07-29 Edwards Lifesciences Corporation Expandable sheath for introducing an endovascular delivery device into a body
US9301841B2 (en) 2008-10-10 2016-04-05 Edwards Lifesciences Corporation Expandable sheath for introducing an endovascular delivery device into a body
US20120123529A1 (en) 2010-10-05 2012-05-17 Edwards Lifesciences Corporation Prosthetic heart valve
US20120239142A1 (en) 2011-02-25 2012-09-20 Jun Liu Prosthetic heart valve delivery apparatus
US10327896B2 (en) 2015-04-10 2019-06-25 Edwards Lifesciences Corporation Expandable sheath with elastomeric cross sectional portions
US10792471B2 (en) 2015-04-10 2020-10-06 Edwards Lifesciences Corporation Expandable sheath
US10856981B2 (en) 2016-07-08 2020-12-08 Edwards Lifesciences Corporation Expandable sheath and methods of using the same
US20180153689A1 (en) 2016-12-06 2018-06-07 Edwards Lifesciences Corporation Mechanically expanding heart valve and delivery apparatus therefor
US10639152B2 (en) 2017-06-21 2020-05-05 Edwards Lifesciences Corporation Expandable sheath and methods of using the same
US11051939B2 (en) 2017-08-31 2021-07-06 Edwards Lifesciences Corporation Active introducer sheath system
US11273062B2 (en) 2018-04-09 2022-03-15 Edwards Lifesciences Corporation Expandable sheath
WO2022155577A1 (fr) * 2021-01-18 2022-07-21 Edwards Lifesciences Corporation Dilatateurs et gaines à caractéristiques d'expansion
US20230346580A1 (en) * 2021-01-18 2023-11-02 Edwards Lifesciences Corporation Dilators and sheaths with expansion features

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