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WO2025155804A1 - Ensemble moyeu-gaine - Google Patents

Ensemble moyeu-gaine

Info

Publication number
WO2025155804A1
WO2025155804A1 PCT/US2025/012004 US2025012004W WO2025155804A1 WO 2025155804 A1 WO2025155804 A1 WO 2025155804A1 US 2025012004 W US2025012004 W US 2025012004W WO 2025155804 A1 WO2025155804 A1 WO 2025155804A1
Authority
WO
WIPO (PCT)
Prior art keywords
sheath
distal
locking nut
spacer
support sleeve
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/US2025/012004
Other languages
English (en)
Inventor
Sonny Tran
Ilan TAMIR
Sovanpheap MAK
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 WO2025155804A1 publication Critical patent/WO2025155804A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0097Catheters; Hollow probes characterised by the hub
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0662Guide tubes

Definitions

  • the present application is directed to an expandable sheath 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.
  • the present disclosure provides a sheath system for deploying a medical device including a reinforced proximal end portion where the sheath is coupled to a sheath hub assembly.
  • 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. However, it should be understood that 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.
  • FIG. 5A is a partial cross-sectional view of the sheath, sheath hub, sheath locking sleeve, introducer locking hub, and introducer of FIG. 2.
  • FIG. 7 is a perspective view of a sheath hub assembly according to another example.
  • FIG. 15 is a perspective view of the sheath hub assembly of FIG. 7, without the sheath locking cap.
  • FIG. 16 is a side view of the sheath hub assembly of FIG. 7, without the sheath locking cap.
  • 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.
  • 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.
  • Disclosed introducer sheaths that are particularly suitable for delivery of implants in the form of implantable heart valves, such as balloon-expandable implantable heart valves.
  • Balloon-expandable implantable heart valves are well-known and will not be described in detail here.
  • An example of such an implantable heart valve is described in U.S. Patent No. 5,411,552, and also in U.S. Patent No.
  • FIG. 1 illustrates an exemplary sheath 8 in use with a representative delivery apparatus 10, for delivering an implant 12, or other type of implantable (for example, tissue heart valve), to a patient.
  • the delivery apparatus 10 can include a steerable guide catheter 14 (also referred to as a flex catheter) and a balloon catheter 16 extending through the guide catheter 14, and a nose catheter 17 extending through the balloon catheter 16.
  • the guide catheter 14, balloon catheter 16, and nose catheter 17 in the illustrated example are adapted to slide longitudinally relative to each other to facilitate delivery and positioning of the implant 12 at an implantation site in a patient's body as described in detail herein.
  • the sheath 8 comprises an elongate expandable tube that, in use, is inserted into a vessel (for example, transfemoral vessel, femoral artery, iliac artery) by passing through the skin of the patient, such that the distal end of the sheath 8 is inserted into the vessel.
  • the sheath 8 includes a hemostasis valve and/or sealing features at the proximal end of the sheath 8, for example, in the sheath hub 20, that provides hemostasis and prevents blood leakage from the patient through the sheath 8.
  • the sheath 8, including an introducer 6, is advanced into the patient's vasculature. Once positioned the introducer 6 is removed and the delivery apparatus 10 is inserted into/through the sheath 8, and the prosthetic device (implant 12) then be delivered and implanted within patient.
  • FIG. 2 illustrates a side view of the sheath assembly with the introducer 6 received within the central lumen 9 of the sheath 8 for placement within the patient's blood vessel.
  • FIG. 3 illustrates a side view of the sheath assembly with the introducer 6 removed and the balloon catheter 16 advanced within the central lumen 9 of the sheath 8.
  • the sheath assembly includes a sheath hub 20 at a proximal end of the device and the expandable sheath 8 extending distally from the sheath hub 20.
  • the sheath locking system 18 keeps the introducer 6 from separating from the sheath 8 and prevents gaps from forming that can cause patient abrasions and unintended fluid flow between the introducer 6 and the sheath 8 when advanced through the patient's blood vessel.
  • Example locking systems are disclosed in PCT/US2021/050006, entitled “Expandable Sheath Including Reverse Bayonet Locking Hub,” the disclosure of which is incorporated herein by reference. It is contemplated that the locking system 18 disclosed herein can also be used to couple the sheath 8/sheath hub 20 with other delivery apparatus components, catheters, dilators, etc. including the same mating features.
  • the locking sleeve 28 includes an elongated sleeve body 29 with a central lumen 56 extending longitudinally between the proximal end and distal end of the sleeve body 29.
  • the central lumen 56 defines a generally cylindrical inner surface 62 of the sheath locking sleeve 28.
  • the distal end of the sleeve body 29 also has a frustoconical outer surface 64 that tapers about the distal end to help with positioning the locking sleeve 28 within the central lumen of the sheath hub 20 and abutting the seal assembly 24 (FIGS. 5A- 5B).
  • the introducer locking hub 30 includes a hub body 32 defining a central lumen 45 extending therethrough. As described herein, the distal portion of the central lumen 45 defines the recessed opening 39 for receiving and retaining the introducer 6. As illustrated in FIG. 6, when coupled, the proximal end of the locking sleeve 28 is received within a distal portion of the central lumen 45 of the introducer locking hub 30. For example, when the locking sleeve 28 and introducer locking hub 30 are coupled, at least a portion of the sleeve body 29 of the sheath locking sleeve 28 is received within the larger diameter portion of the central lumen 45 of the introducer locking hub 30. As illustrated in FIG.
  • the inner surface 164 of the second distal spacer 160 has an increasing taper extending from the distal end surface 162 toward the proximal end surface 165 of the second distal spacer 160.
  • the taper of the inner surface 164 corresponds to the taper of the body portion 133 of the support sleeve 130.
  • the inner diameter of the inner surface 164 at the distal end of the second distal spacer 160 is less than the inner diameter of the inner surface 164 at the proximal end of the second distal spacer 160.
  • the projections 142 have a generally triangular shape with angled side edges 146 extending from the base member 144 to an inside edge 148.
  • the inside edge 148 of the projections 142 includes a curved surface, having a curvature corresponding to the curvature of the base member 144.
  • the inside edge 148 has a generally linear shape extended between the ends of the side edges 146.
  • the diameter of the distal reduced diameter portion 126 is less than the diameter of the proximal reduced diameter portion 128.
  • the first distal spacer 150 abuts the first shoulder 123 and the distal seal member 170 abuts the second shoulder 127.
  • the sheath locking nut 120 includes a coupling interface for coupling the sheath locking nut 120 with the sheath hub 110.
  • the coupling interface can include a threaded coupling, a press fit, an interference fit, a snap fit, a mechanical fastener, a chemical fastener (for example, an adhesive), a weld, a thermal process, and/or any other suitable coupling process known in the art.
  • the sheath locking nut 120 includes a threaded surface 129 sized and configured to engage a corresponding threaded surface provided on the outer surface of the sheath hub 110.
  • the threaded surface 129 extends from the proximal end 124 of the sheath locking nut 120 toward the proximal reduced diameter portion 128.
  • the distal end of the sheath hub 110 includes a threaded surface 114 for coupling with the corresponding threaded surface 129 provided on the sheath locking nut 120.
  • a method of securing the delivery sheath 8 to a sheath hub 110 using a sheath hub assembly 100 is described herein.
  • the proximal end of the sheath 8 is positioned between the sheath hub 110 and the sheath locking nut 120 such that coupling/tightening the sheath locking nut 120 to the sheath hub 110 fixes the sheath 8 to the sheath hub 110.
  • the method includes providing an expandable sheath 8 as described and incorporated herein.
  • the sheath 8 includes a central lumen 9 through which the medical device (implant 12) and/or delivery apparatus 10 travels into the patient's vessel in order to deliver, remove, repair, and/or replace a prosthetic device.
  • the sheath 8 can have a natural, unexpanded outer diameter that will expand locally upon passage of the medical device.
  • the expandable sheath 8 can comprise a plurality of coaxial layers extending along at least a portion of the length of the sheath 8.
  • the coaxial layers include one or more folded portions extending along a length of the sheath 8.
  • the structure of the coaxial layers is described in more detail, for example, in U.S. Patent Application No. 16/378,417, entitled “Expandable Sheath,” U.S. Patent Application No. 17/716,882, entitled “Expandable Sheath,” and U.S. Patent Application No. 14/880,109, entitled “Expandable Sheath,” the disclosures of which are herein incorporated by reference.
  • the method includes providing a sheath hub assembly 100 as described herein. In some examples, the method further includes positioning a proximal seal member 190 on the sheath hub 110. As illustrated in FIG. 9, the proximal seal member 190 is positioned adjacent to and/or abuts the shoulder 118, distal the threaded surface 114 of the sheath hub 110.
  • the support sleeve 130 is then positioned adjacent/on the distal end of the sheath hub 110 such that the proximal seal member 190 is located between the proximal end 137 of the support sleeve 130 and the sheath hub 110.
  • the proximal seal member 190 is compressed between the support sleeve 130 and the shoulder 118 on the sheath hub 110.
  • the method further includes positioning the second distal spacer 160 on the body portion 133 of the support sleeve 130.
  • the second distal spacer 160 is advanced along the body portion 133, such that the distal seal member 170 is located between the second distal spacer 160 and the proximal spacer 180.
  • the method further includes positioning the anchor 140 over the body portion 133 of the support sleeve 130.
  • the anchor 140 is advanced over the body portion 133 such that at least a portion of the anchor 140 is located proximate and or abuts the proximal end surface 165 of the second distal spacer 160.
  • the sheath locking nut 120 is then advanced over the body portion 133 of the support sleeve 130 and associated sheath hub assembly 100 components provided thereon.
  • the sheath locking nut 120 is initia lly/pa rtially coupled to the sheath hub 110.
  • the threaded surface 129 provided on the sheath locking nut 120 is partially threadably coupled to the corresponding threaded surface 114 provided on the sheath hub 110.
  • a distal end portion of the body portion 133 of the support sleeve 130 extends through and beyond a distal opening 125 of the sheath locking nut 120.
  • sheath 8 is advanced into the sheath hub assembly 100.
  • the proximal end 102 of the expandable sheath 8 is advanced over the body portion 133 of the support sleeve 130, such that the support sleeve 130 is received within the central lumen 9 of the sheath 8.
  • a portion of the body portion 133 extends through the distal opening 125 of the sheath locking nut 120 and provides a leading surface for supporting and/or guiding the expandable sheath 8 as it is loaded into the sheath hub assembly 100.
  • the proximal end 102 of the expandable sheath 8 is advanced over the portion of the body portion 133 extending through the distal opening 125 of the sheath locking nut 120 and into/through the distal opening 125 of the sheath locking nut 120.
  • the distal opening 125 of the sheath locking nut 120 has a diameter ranging from 420 mm to 485 mm. In some examples, the diameter of the distal opening 125 ranges from 440 mm to 465 mm. In some examples, the diameter of the distal opening is approximately 440 mm.
  • the proximal end 102 of the sheath 8 is further advanced into the central lumen 122 of the sheath locking nut 120 and over the body portion 133 of the support sleeve 130 and into the space/gap provided between the support sleeve 130 and the first distal spacer 150, second distal spacer 160, anchor 140, distal seal member 170, and the proximal spacer 180.
  • the sheath 8 is advanced within the sheath locking nut 120/over the body portion 133 until the proximal end 102 of the sheath 8 of is located adjacent the shoulder 135 of the support sleeve 130.
  • the sheath 8 is advanced within the sheath locking nut 120/over the support sleeve 130 until the proximal end 102 of the sheath 8 abuts the shoulder 135 of the support sleeve 130. As illustrated in FIG. 9, the sheath 8 is advanced over the support sleeve 130 such that the sheath 8 extends proximally beyond the distal seal member 170 and is positioned between the distal seal member 170 and the elongated body portion 133 of the support sleeve 130. In some examples, the sheath 8 extends along the support sleeve 130 a length ranging from 0.2" to 0.8". In some examples, the expandable sheath 8 extends along the support sleeve 0.6".
  • the sheath locking nut 210 is separate from/not (partially) coupled to the sheath hub 110 before the sheath 8 is advanced over the support sleeve 130.
  • the sheath 8 is advanced into position over the support sleeve 130 until the proximal end 102 of the sheath 8 is located adjacent the shoulder 135 of the support sleeve 130.
  • the distal end of the sheath 8 is advanced within the central lumen 122 of the sheath locking nut 120, and the sheath locking nut 120 is advanced over the sheath 8 to the sheath hub 110.
  • the sheath locking nut 120 is then coupled to the sheath hub 110 as described herein.
  • the further engagement between the sheath locking nut 120 and the sheath hub 110 compresses the distal seal member 170 between the distal end surface 186 of the proximal spacer 180 and the proximal end surface 165 of the second distal spacer 160 thereby providing an inwardly directed force against the support sleeve 130 and/or a portion of the expandable sheath 8 extending between the support sleeve 130 and the distal seal member 170.
  • compression of the distal seal member 170 against the sheath 8 prevents blood flow between the expandable sheath 8 and the outer surface of sheath hub 110, ensuring hemostasis/prevent blood flow between the expandable sheath 8 and the sheath hub assembly 100.
  • the further engagement between the sheath locking nut 120 and the sheath hub 110 compresses the proximal seal member 190 between the proximal end 137 of the support sleeve 130 and the distal end of the sheath hub 110. This helps to seal the connection between the expandable sheath 8 and the outer surface of the sheath hub 110.
  • advancing the medical device (implant 12) through the central lumen 9 of the sheath 8 can include advancing the delivery apparatus 10 and the medical device through the central lumen 9 of the sheath 8 and into the vasculature of a patient. 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 8 to create an opening in the patient's heart tissue.
  • the sheath 8 is inserted into a femoral artery of the patient.
  • a system for connecting an expandable sheath to a sheath hub including: an expandable sheath; a sheath locking nut for securing the expandable sheath to a sheath hub, the sheath locking nut including a central lumen extending therethrough; a support sleeve received within the sheath locking nut, the support sleeve for providing a support surface for the expandable sheath and including a central lumen coaxial with the central lumen of the sheath locking nut; and an anchor provided within the central lumen of the sheath locking nut for providing a compressive force against the expandable sheath when received within the central lumen of the sheath locking nut, the anchor securing the expandable sheath between the sheath locking nut and the support sleeve.
  • Example 2 The system according to any example herein, particularly example 1, further including: a first distal spacer received within the central lumen of the sheath locking nut adjacent a distal end of the sheath locking nut; and a second distal spacer received within the central lumen of the sheath locking nut, where the first distal spacer is positioned between the second distal spacer and the distal end of the sheath locking nut, wherein the anchor is positioned between the first distal spacer and the second distal spacer.
  • Example 3 The system according to any example herein, particularly example 2, wherein first distal spacer includes an elongated annular-shaped body portion that extends around the support sleeve, a distal end surface of the first distal spacer abuts a first shoulder provided on the central lumen of the sheath locking nut, and a proximal end surface of the first distal spacer defines a tapered surface.
  • Example 4 The system according to any example herein, particularly example 3, wherein the tapered surface of the proximal end surface of the first distal spacer extends in a direction transverse to a longitudinal axis of the first distal spacer from an inner surface of the first distal spacer in a direction toward a distal end of the first distal spacer.
  • Example 5 The system according to any example herein, particularly examples 3-4, wherein an inner surface of the body portion of the first distal spacer has an increasing taper extending from the distal end surface towards the proximal end surface of the first distal spacer.
  • Example 6 The system according to any example herein, particularly examples 2-5, wherein the second distal spacer includes an elongated annular-shaped body portion that extends around the support sleeve, a distal end surface of the second distal spacer has a curved inner edge extending between the distal end surface and an inner surface of the body portion.
  • Example 7. The system according to any example herein, particularly examples 2-5, wherein the second distal spacer includes an elongated annular-shaped body portion that extends around the support sleeve, a distal end surface of the second distal spacer has a curved inner edge extending between the distal end surface and an inner surface of the body portion.
  • distal end surface of the second distal spacer defines a tapered surface extending from an outer surface of the second distal spacer toward the curved inner edge, the tapered surface extending in a direction transverse to a longitudinal axis of the second distal spacer from the curved inner edge toward a distal end of the second distal spacer.
  • Example 9 The system according to any example herein, particularly examples 2-8, wherein the anchor is positioned between the first distal spacer and the second distal spacer.
  • Example 10 The system according to any example herein, particularly example 9, wherein the anchor has a generally planar shape and compressing the anchor between the first distal spacer and second distal spacer causes at least a portion of the anchor to deform into an angled shape and extend radially into the central lumen of the sheath locking nut toward the support sleeve (for example, contact between the anchor and the tapered proximal end surface of the first distal spacer and/or the tapered distal end surface of the second distal spacer causes the anchor to bend to a corresponding angle).

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

Abstract

L'invention concerne des gaines d'introducteur et des procédés d'utilisation de celles-ci. Le système peut comprendre une gaine extensible, un écrou de blocage de gaine destiné à fixer la gaine extensible à un moyeu de gaine, un manchon de support reçu à l'intérieur de l'écrou de blocage de gaine, le manchon de support servant à fournir une surface de support pour la gaine extensible et comprenant une lumière centrale coaxiale à la lumière centrale de l'écrou de blocage de gaine, ainsi qu'un ancrage disposé à l'intérieur de la lumière centrale de l'écrou de blocage de gaine pour fournir une force de compression contre la gaine extensible lorsqu'il est reçu à l'intérieur de la lumière centrale de l'écrou de blocage de gaine, l'ancrage fixant la gaine extensible entre l'écrou de blocage de gaine et le manchon de support.
PCT/US2025/012004 2024-01-18 2025-01-17 Ensemble moyeu-gaine Pending WO2025155804A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202463622378P 2024-01-18 2024-01-18
US63/622,378 2024-01-18

Publications (1)

Publication Number Publication Date
WO2025155804A1 true WO2025155804A1 (fr) 2025-07-24

Family

ID=94536434

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2025/012004 Pending WO2025155804A1 (fr) 2024-01-18 2025-01-17 Ensemble moyeu-gaine

Country Status (1)

Country Link
WO (1) WO2025155804A1 (fr)

Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2008643A1 (fr) * 1989-01-27 1990-07-27 James F. Crittenden Systeme d'echange de catheters avec raccord luer detachable
US5411552A (en) 1990-05-18 1995-05-02 Andersen; Henning R. Valve prothesis for implantation in the body and a catheter for implanting such valve prothesis
US20070005001A1 (en) * 2005-06-30 2007-01-04 Abbott Laboratories Modular introducer and exchange sheath
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
US9393110B2 (en) 2010-10-05 2016-07-19 Edwards Lifesciences Corporation Prosthetic heart valve
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
US10792471B2 (en) 2015-04-10 2020-10-06 Edwards Lifesciences Corporation Expandable sheath
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
US20230270547A1 (en) * 2020-10-13 2023-08-31 Edwards Lifesciences Corporation Expandable sheath including smart introducer

Patent Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2008643A1 (fr) * 1989-01-27 1990-07-27 James F. Crittenden Systeme d'echange de catheters avec raccord luer detachable
US5411552A (en) 1990-05-18 1995-05-02 Andersen; Henning R. Valve prothesis for implantation in the body and a catheter for implanting such valve prothesis
US20070005001A1 (en) * 2005-06-30 2007-01-04 Abbott Laboratories Modular introducer and exchange sheath
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
US9393110B2 (en) 2010-10-05 2016-07-19 Edwards Lifesciences Corporation Prosthetic heart valve
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
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
US20230270547A1 (en) * 2020-10-13 2023-08-31 Edwards Lifesciences Corporation Expandable sheath including smart introducer

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