WO2021113395A1 - Procédé de chargement de cathéter dans une valvule veineuse implantable et appareil associé - Google Patents

Procédé de chargement de cathéter dans une valvule veineuse implantable et appareil associé Download PDF

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Publication number
WO2021113395A1
WO2021113395A1 PCT/US2020/062937 US2020062937W WO2021113395A1 WO 2021113395 A1 WO2021113395 A1 WO 2021113395A1 US 2020062937 W US2020062937 W US 2020062937W WO 2021113395 A1 WO2021113395 A1 WO 2021113395A1
Authority
WO
WIPO (PCT)
Prior art keywords
valve
funnel
crimping
locking member
pusher
Prior art date
Application number
PCT/US2020/062937
Other languages
English (en)
Inventor
Taylor KIRK
Christopher POMERLEAU
Janet Burpee
Original Assignee
Venarum Medical, Llc
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 Venarum Medical, Llc filed Critical Venarum Medical, Llc
Publication of WO2021113395A1 publication Critical patent/WO2021113395A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9522—Means for mounting a stent or stent-graft onto or into a placement instrument
    • A61F2/9525—Means for mounting a stent or stent-graft onto or into a placement instrument using a funnel
    • 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
    • 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
    • A61F2/2475—Venous valves
    • 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
    • A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents

Definitions

  • This invention relates to a process and apparatus for on-site loading an implantable valve into a delivery catheter. More particularly, the invention relates to catheter loading an implantable venous valve in the operating room for treating venous insufficiency. BACKGROUND OF THE INVENTION
  • veins in the leg work against gravity and pump blood towards the heart. Healthy function of venous anatomy depends strongly on a series of one-way valves that can open and close, with assistance from the venous pump, a collection of skeletal muscles that can aid in the circulation of blood by muscle contractions; the valves act as one-way pressure regulators to negate the effects of gravity-induced hydrostatic blood pressure, especially in the standing position where pressures of over 90 mm Hg can be experienced.
  • venous insufficiency a condition known as venous insufficiency or over a long-term, chronic venous insufficiency or CVI develops.
  • Venous valve reflux causes stagnant blood to pool in the leg leading to fluid/blood cell leakage into the skin and other tissues.
  • Venous valve dys function is caused either primarily by congenitally weak valves; or secondarily by direct trauma, thrombosis, hormonal changes (e.g., preg- nancy), and/or prolonged standing or sitting. The condition is diagnosed through physical examination, venous duplex ultrasonography, and venous air plethysmography, or less commonly by contrast venography.
  • CVI can manifest itself in both superficial and deep veins. Since a superficial vein is not paired with an artery, CVI in a superficial vein typically has minor health implications and can be more readily treated or removed without concern for circulatory health. A deep vein is well beneath the skin and is paired with an artery. These paired veins carry most of the blood in the body, and given their importance to circulation, are not typically removed. The risks related to untreated CVI are severe and include major injury and death from deep vein thrombosis (DVT); DVT is the formation of a blood clot in deep veins typically in the legs, thighs, or pelvis. In mild cases, CVI may cause chronic itchy skin, slight pain and swelling; in moderate to severe cases, CVI may cause lifestyle interfering edema, ulcerations and infections (cellulitis, lymphangitis).
  • DVT deep vein thrombosis
  • the invention provides a process for loading an implantable venous valve on-site in the operating room just prior to deploying the valve, which starts with:
  • a catheter delivery system including: (i) a guide wire lumen having a distal tip; (ii) an inner sheath capable of moving distally and proximally over the guide wire lumen having a locking member at the end thereof; and (iii) a retractable outer sheath over the inner sheath;
  • a crimping station including a base, a crimping funnel attached to the base and a valve pusher slidably mounted on the base with means to fix its location relative to the funnel, the pusher having a recessed end facing the funnel and an opposite end;
  • a venous valve including: (i) a partially or completely polymer encased expandable scaffold having a distal section for blood inflow; (ii) a bulbous center section having an inner polymer wall; (iii) a proximal section for blood out-flow having terminal locking elements adapted to interlock with the locking member of the inner sheath; and (iv) a polymer valve having valve leaflets attached to the bulbous polymer wall with proximal ends forming a valve outlet, which opens and closes in response to venous blood flow.
  • the process is carried out by:
  • the invention also provides an apparatus for carrying out the inventive process, which includes:
  • a catheter delivery system including: (i) a guide wire lumen having a distal tip; (ii) an inner sheath capable of moving distally and proximally over the guide wire lumen having a locking member at the end thereof; and (iii) a retractable outer sheath over the inner sheath;
  • a crimping station including a base, a crimping funnel attached to the base and a valve pusher slidably mounted on the base with means to fix its location relative to the funnel, the pusher having a recessed end facing the funnel and an opposite end;
  • a venous valve including: (i) a polymer encased expandable scaffold having a distal section for blood inflow; (ii) a bulbous center section having an inner polymer wall; (iii) a proximal section for blood out-flow having terminal locking elements adapted to interlock with the locking member of the inner sheath; and (iv) a polymer valve having valve leaflets attached to the bulbous polymer wall with proximal ends forming a valve outlet, which opens and closes in response to venous blood flow.
  • Fig. 1A is a plan view of the components used to carry out the process of the invention including a valve 10, funnel 12, valve pusher 14, base 16 and catheter 18;
  • Fig. IB is a plan view of valve 10 inserted into pusher 14;
  • Fig. 1C is a top plan view of base 16 with funnel 12 and pusher 14 affixed thereto with the valve/pusher assembly shown in Fig. IB positioned adjacent the wide end of funnel 12;
  • Fig. ID is a top plan view of the catheter with its outer sheath retracted and positioned on the base assembly shown in Fig. 1C;
  • Fig. IE is a top plan view of the base assembly of Fig. ID with a cross sectional view showing the distal end of the valve advanced by pusher 14 beyond the narrow end of the funnel;
  • Fig. IF is a cross sectional view of Fig. IE with the catheter inner sheath locking member and the valve locking members interlocked;
  • Fig. 1G is a cross sectional view of the catheter outer sheath advanced over the interlocked assembly of Fig. IF;
  • Fig. 1H is a cross sectional view of a catheter loaded with a valve, which is ready for deployment by a surgeon;
  • Fig. 2 is a perspective view of the inventive crimping apparatus
  • Fig. 3 is a top plan view of the system assembled on a tray for packaging, sterilization, and use in an operating room or catheter lab.
  • FIG. 1A An example of a suitable venous valve in shown in Fig. 1A and includes expandable scaffold 2 encased in polymer 7 and polymer valve 6.
  • Valve 10 has distal section 5 for blood inflow, bulbous center section 4 having an inner polymer wall and proximal section 3 for blood out-flow having terminal locking elements 26 adapted to interlock with the locking member of an inner sheath of a catheter as described herein.
  • Polymer valve leaflets 6 are attached at their distal ends to bulbous polymer wall with proximal ends of the leaflets forming a valve outlet, which opens and closes in response to venous blood flow.
  • valve is as described herein and in U.S. Patent Application No. 15/306,121, filed Oct. 24, 2016, now U.S. Patent No. 10,492,910, issued December 3, 2019.
  • An improved valve is also described in U.S. Provisional Patent Application Nos. 62/942,744 and 63/960,587, filed December 2, 2019 and January 13, 2020, respectively.
  • Suitable venous valves 10 can have inside diameters of 8 mm, 10 mm and 12 mm that are adapted for use in veins having inside diameters of 6.5 to 7.5 mm, 7.5 to 9.5 mm and 9.5 to 11.5 mm, respectively.
  • eyelets 44 are provided on each terminal section of distal section 5 whereas interlocking eyelet 26 are attached to every other terminal section of proximal section 3. Eyelets 44 distribute the pushing force applied via pusher 14 and can be provided with blunt or squared-off ends 44' or be recessed at 44" leaving the push force to be carried by the terminal ends of distal section 5 (Fig. IB).
  • the valve can also be loaded by interlocking features on the distal end to accommodate antegrade access and deployment from a delivery catheter.
  • catheter 18 includes guide wire lumen 20 having distal tip 22, which has a terminal aperture for passage of a guide wire through an Internal lumen and/or rapid exchange.
  • Inner sheath 21 is capable of moving distally and proximally with guide wire lumen 20 and has terminal locking member 23 with interlocking recesses 24, which mate with interlocking eyelets 26 as described in greater detail herein.
  • Retractable outer sheath 19 moves over inner sheath 21 in both directions.
  • the crimping station includes base 16, crimping funnel 12 releasably attached to base 16 via rails 32 and 32' and set screw 34 carried by bracket 33.
  • Axially apertured valve pusher 14 is slidably mounted on base 16 via rails 35 and 35' and set screw 37 carried by bracket 36.
  • Pusher 14 has recessed end 14', 14" facing and axially aligned with funnel 12. Brackets 30 and aperture bracket 30' align catheter 18 with funnel 12 and pusher 14. Funnel 12 has a smooth, true conical taper starting at the widest end 12' and tapering to the narrowest opening 12" at the opposite end. Valve 10 may be advanced into funnel 2 in any axial orientation with the end goal of aligning proximal or distal locking elements 26 or 44 with interlocking recesses 24 of locking member 23 at the end of inner sheath
  • the process is carried out by: inserting distal section 5 into the recessed end 14', 14" of valve pusher 14 (Fig. IB) and positioning proximal section 3 of the valve/pusher assembly adjacent wide end 12' of crimping funnel 12 (Fig. 1C); retracting outer sheath 19 of catheter 18 to expose terminal locking member 23 of inner sheath 21 and inserting distal tip 22 of guide wire lumen 20 into narrow end 12" of crimping funnel 12, thru the valve leaflets 6 of valve 10 and into pusher 14 beyond recess 14'/14" or thru pusher 14 (Fig.
  • FIG. 1H shows the system comprising catheter 18, valves 10 and the crimping station shown in Fig. 2 assembled on a tray for packaging, sterilization, and use in an operating room or catheter lab.
  • the scaffold can be made of a superelastic alloy such as NitinolTM.
  • the bulbous center section has an axial cross section where the minimum chord is smaller than the vein diameter, but the perimeter for that axial cross section is larger than the perimeter of the vein cross section such that the device, and in particular the bulbous section, is oversized. This embodiment may allow for a smaller opening at the valve opening that enables a local maximum of pressure.
  • the leaflets can be tapered where it is preferred that the leaflets are each thinnest at the valve outlet to maximize flexibility at the valve outlet, and thickest at the connection to the frame to maximize durability. Further, it may be desirable to have the leaflets as short as possible while still providing adequate valve function in order to minimize possible areas of leaflet overlap, and possible areas of blood stagnation.
  • Usable polymers have excellent strength, elongation and durability suitable for high cycle fatigue applications in a body.
  • the leaflets and frame polymer can be created from different polymers adjacent to one another or composed of one continuous singular polymeric material or blend.
  • a polymer that is less thrombo-resistant may be used in conjunction with another thrombo-resistant polymer or coating, which would be the primary surface for blood contact.
  • a polymer that is less thrombo- resistant may be used if the clinical need does not require it for clinical success of given device.
  • Alternatives for creating certain aspects of the design from dip coating, spray coating or similar methods where the polymer is liquefied in a solvent include fabrication from sheets, premolds or similar solid non-liquefied materials.
  • the leaflets can be cut from a polymer sheet then welded or otherwise attached to other parts of the inner-valve or frame.
  • Usable polymers include polyurethane or polyurethane blends, sili cone or silicone blends, polycarbonate or polycarbonate blends, or layers of polymers including those to enhance anti-thrombogenicity; and they can provide a smooth and hemocompatible surface, which is moldable, castable, and/or able to be applied by dip coating, spray coating or the like.
  • Non-polymer materials can also be blended in with the polymer or polymers.
  • the polymer or polymer blend can be endothelial cell forma tion.
  • the polymers may not be specifically anti-thrombogenicity if all polymers are covered with an anti-thrombogenicity coating. Examples of commercially available polymers and additives are given in the following table:
  • body vessels There are many types of body canals, blood vessels, ducts, tubes and other body passages, and the term "vessel" is meant to include all such passages.

Abstract

Un procédé et un appareil pour charger une valvule veineuse implantable sur site avant le déploiement de la valvule utilisent un système de pose de cathéter ayant un élément de verrouillage de valvule, une station de sertissage comprenant un entonnoir de sertissage et un poussoir de valvule et une valvule veineuse comprenant une section d'extrémité ayant des éléments de verrouillage terminaux conçus pour se verrouiller avec l'élément de verrouillage de cathéter. La valvule verrouillée est sertie et retirée dans le cathéter pour un déploiement dans un vaisseau corporel, en particulier une veine.
PCT/US2020/062937 2019-12-02 2020-12-02 Procédé de chargement de cathéter dans une valvule veineuse implantable et appareil associé WO2021113395A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962942743P 2019-12-02 2019-12-02
US62/942,743 2019-12-02

Publications (1)

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WO2021113395A1 true WO2021113395A1 (fr) 2021-06-10

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070270932A1 (en) * 2006-05-19 2007-11-22 Boston Scientific Scimed, Inc. Apparatus and method for loading and delivering a stent
US20100049313A1 (en) * 2008-08-22 2010-02-25 Edwards Lifesciences Corporation Prosthetic heart valve and delivery apparatus
US20120083875A1 (en) * 2010-09-17 2012-04-05 Johnson Michael A Assembly and method for loading a self-expanding collapsible heart valve
US20170367821A1 (en) * 2016-06-24 2017-12-28 Edwards Lifesciences Corporation System and method for crimping a prosthetic valve
US20190099271A1 (en) * 2015-10-13 2019-04-04 Venarum Medical Llc Implantable valve and method

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070270932A1 (en) * 2006-05-19 2007-11-22 Boston Scientific Scimed, Inc. Apparatus and method for loading and delivering a stent
US20100049313A1 (en) * 2008-08-22 2010-02-25 Edwards Lifesciences Corporation Prosthetic heart valve and delivery apparatus
US20120083875A1 (en) * 2010-09-17 2012-04-05 Johnson Michael A Assembly and method for loading a self-expanding collapsible heart valve
US20190099271A1 (en) * 2015-10-13 2019-04-04 Venarum Medical Llc Implantable valve and method
US20170367821A1 (en) * 2016-06-24 2017-12-28 Edwards Lifesciences Corporation System and method for crimping a prosthetic valve

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