WO2022173997A1 - Systèmes, dispositifs et procédés de systèmes d'administration - Google Patents

Systèmes, dispositifs et procédés de systèmes d'administration Download PDF

Info

Publication number
WO2022173997A1
WO2022173997A1 PCT/US2022/016042 US2022016042W WO2022173997A1 WO 2022173997 A1 WO2022173997 A1 WO 2022173997A1 US 2022016042 W US2022016042 W US 2022016042W WO 2022173997 A1 WO2022173997 A1 WO 2022173997A1
Authority
WO
WIPO (PCT)
Prior art keywords
delivery system
rotor
stator
proximal
distal
Prior art date
Application number
PCT/US2022/016042
Other languages
English (en)
Inventor
Daniel T. Wallace
Peter W. GREGG
Jeremy J. Boyette
Evelyn N. Haynes
Spencer C. NOE
Diana L. CHU
Original Assignee
Occam Labs 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
Priority claimed from US17/179,308 external-priority patent/US11246726B1/en
Application filed by Occam Labs LLC filed Critical Occam Labs LLC
Priority to EP22753382.5A priority Critical patent/EP4291277A1/fr
Priority to CN202280020414.3A priority patent/CN117042828A/zh
Priority to US18/264,626 priority patent/US20240081991A1/en
Publication of WO2022173997A1 publication Critical patent/WO2022173997A1/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
    • A61F2/02—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
    • A61F2/2412—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
    • 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
    • A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
    • 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
    • A61F2002/9534—Instruments specially adapted for placement or removal of stents or stent-grafts for repositioning of stents
    • 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
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2002/9665—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means

Definitions

  • FIGS. 10A and 10B are front and rear perspective views of the stator shaft.
  • FIGS. 10C and 10D are side elevational and side cross-sectional views of the stator shaft in FIGS.
  • FIGS. 13A to 13F are top perspective, bottom perspective, top plan, bottom plan, side elevational and fiont/rear elevational views, respectively, of the proximal segment of the distal steering assembly in FIG. 12, with perimeter bumpers.
  • FIGS. 13G to 13L are top perspective, bottom perspective, top plan, bottom plan, side elevational and fiont/rear elevational views, respectively, of the proximal segment of the distal steering assembly in FIG. 12, without perimeter bumpers.
  • FIGS. 16A and 16B are top perspective views of the combined proximal steering and extension assembly, in a retracted and extended configuration, respectively.
  • FIG. 16C is a front elevational view of the extension assembly in FIGS. 16A and 16B
  • FIG. 16D is a rear elevational view of the proximal steering assembly in FIGS. 16A and 16B.
  • FIGS. 16E to 16H are top plan, top cross-sectional, side elevational and side cross-sectional views, respectively, of the combined proximal steering and extension assembly of FIG. 16A in a retracted configuration.
  • FIGS. 28A to 28C depicts a stator shaft with optional wire loop structures to alter the tension member routing.
  • FIG. 28D is a schematic cutaway view of the stator shaft in FIGS. 28A to 28C in an assembly and tension member routing
  • FIGS. 45A to 45D are various perspective views of the distal rotor connector.
  • the perimeter of the atrial brim 2606 is not coupled to a tension member or rotor/stator assembly, and is permitted to at least partially expand upon withdrawal of the retractable sheath 2652, as depicted in FIG. 26B. Because the inner atrial opening 2612 is held in a constrained configuration by tension members 2664, the atrial brim 2606 is not yet fully expanded against the surrounding anatomy.
  • the drive shaft casing 616 may comprise, for example, a helical hollow strand torque tube.
  • the stator body 602 may be attached or coupled to the proximal steering assembly 124, without the drive shaft casing.
  • the structure of the proximal steering assembly 124 serves to resist rotation of the stator body 602 as the rotor shaft 702 is rotated, as no torque tube or drive shaft casing is provided.
  • the stator body 602 may be inserted and/or directly welded to the distal segment of the steering assembly, such as the central opening 1530 of the exemplary distal segment 1500 depicted in FIGS. 15A to 15L. In other variations, as depicted in FIGS.
  • FIG. 37A depicts an embodiment of a rotor plate 3700 comprising a central opening 3702 for mounting to the rotor shaft, and also three symmetric groups of attachment structures.
  • the attachment structures of each group include a first elongated, straight projection 3704, which has a length in the range of about 2 mm to 15 mm, 2 mm to 10 mm, or 3 mm to 6 mm, or a length that is in the percentage range relative to the radius (center to maximum perimeter distance) in the range of about 10% to 80%, 20% to 70%, or 25 to 60%.
  • the projection may also be characterized by the absolute distance from center of the plate to the base 3724 of the projection 3704, or the relative location of the base of the projection, as a percentage of the radial distance from the center to the maximum perimeter distance of the rotor plate.
  • This relative location may be in the range of 10% to 90%, 20% to 80%, 40% to 80%, for example.
  • the absolute distance may be in the range of 1 mm to 12 mm, 2 mm to 8 mm, or 2 mm to 6 mm, for example.
  • the longitudinal axis of the projection may be aligned, parallel or at an angle to a radius or diameter of the rotor plate intersecting the center of the base of the projection. In the example depicted in FIG.
  • the smaller aperture 3728 may be circular or oval, and the larger aperture 3730 or the aperture with the projection may polygonal or square, though in still other variations, each of the apertures may instead be circular, oval, polygonal, square, rectangular, and the like, and/or may be closed or open in configuration, relative to the perimeter of the plate.
  • the projection 3732 may comprise a length that that may be similar to the length as describes for projections of FIG. 37A, or may comprise a length that extends into the center of the surrounding aperture, or a length that is a percentage of the distance from the base of the projection 3732 to the farthest edge of the surrounding aperture 3730 along the longitudinal axis of the projection 3732.
  • FIGS. 37C and 37D depict still other variations of a rotor plate, respectively, comprising a single configuration of projections, compared to FIG. 37A.
  • the base of the projections 3736 of the rotor plate 3734 lies closer to the perimeter of the plate 3734 than the center opening 3738, but extends to an asymmetric distal end with a gap 3740 on one side of the projection 3736 that has a region of uniform width and extends to the plate center less than 50% of the radius of the plate, and a shallow gap 3742 with v- shaped sides on the other side of the projection 3736 that extends less than 20% of the radial distance toward the center.
  • FIG. 31C schematically depicts how a tension loop or line 3150, 3152 may be routed using the control rings 3130, 3134.
  • One tension loop or line 3150 may be looped around or tied to the rotor attachment structure or rotor plate 3160b of the rotor shaft 3104, routed out one of the guide openings 3118 of the distal stator housing 3108b.
  • the stator tube 3522 is also fixedly attached to a distal implant attachment structure 3524, which includes one or more implant recesses 3526 that are configured to releasably retain one or more structures of the implant
  • the recesses 3526 are further configured to receive and release the implant structure in the radial axis, while resisting displacement of the implant structure in the longitudinal axis.
  • the retention sheath 3504 is configured to fully retain the implant in the sheath cavity 3506, when sheath 3504 is in its proximal position, as depicted in FIG. 35D. As the rotor shaft is rotated, the sheath 3504 will advance distally, to expose the proximal end 3552 of the implant 3550, as depicted in FIGS.
  • the interface ends 1402, 1404 are also configured to interfiice with the complementary other configuration of end 1402, 1404 of another middle segment 1400.
  • the segment interface ends 1302, 1402, 1404, 1504 are configured as a single-axis, two- way bend at each articulation between the interface ends 1302, 1402, 1404, 1504 but with the distal steering assembly 128 comprising interfaces with different orientations, e.g. one set of interfaces 1302, 1402 having an orthogonal orientation to the other set of interfaces 1404, 1504, the assembly 128 as a whole is configured as a four-way, two axis bending assembly.
  • each of the segments 1300, 1400, 1500 comprises a center or primary opening 1330, 1430, 1530 through which the drive shaft of the delivery system may reside.
  • Segments 1300, 1400 further comprise bending openings 1332, 1432, 1532 in which a steering wire or element may reside.
  • the distal segment 1500 may comprise attachment structures to which the steering wires or elements attach, rather than pass through to attach to structures distal to the distal segment.
  • the bending openings 1332, 1432, 1532 may be orientated such that they are spaced 90 degrees apart, and spaced 45 degrees apart from an adjacent alignment structure 1314, 1414, 1514.
  • each segment 1602, 1604, 1606 also comprises a pair of notches 1644 and/or protrusions 1646 which are slidable in the notches 1644.
  • the notches 1644 and protrusions 1646 may resist torsional forces that are acting on the proximal steering assembly 124 and/or may also provide or support the limit on the amount of flexion between each segment 1602, 1604, 1606, based on the longitudinal length of the notches 1644 and protrusions 1646.
  • the lengths of the notches may be in the range of 12 mm to 25 mm, 15 mm to 22 mm, or 16 mm to 20 mm, and the lengths of the protrusions may be in the range of 1.5 mm to 2.5 mm, 1.7 mm to 2.2 mm, or 1.8 mm to 2.0 mm.
  • the widths of the notches and protrusions may be in the range of 0.8 mm to 2 mm, 1.0 mm to 1.8 mm, or 1.1 mm to 1.4 mm.
  • a mechanical stop structures may be provided on the worm gear or threaded shaft to provide a limit on the amount of extension.
  • the proximal end of the worm gear or threaded shaft that controls this extension may be mechanically coupled to a rotatable knob 106 on the handle 102, which is described below.
  • the lever 1932 is maintained in a biased lock configuration via a spring 1936 that pulls the locking head 1938 into engagement with the secondary body 1944 of the knob 1940 to resist rotation.
  • the knob 1940 may be rotated by the user.
  • the stator shaft 1950 of delivery device 1900 does not longitudinally displace due to the lack of an extension assembly, but may be coupled to the handle 1902 via an adhesive bond and/or a mechanical interfit or interference interlace.
  • the stator shaft 1950 is coupled to a stator key block 1952 via a set screw or other mechanical fastener.
  • the block 1952 is located in a block cavity 1954 with a complementary cavity shape to the outer surface of the stator key block 1952 to thereby resist rotational and longitudinal displacement.
  • the patient is positioned on the procedure table, and the draped and sterilized in the usual fashion. Anesthesia or sedation is achieved. Percutaneous or cutdown access to the vascular or entry site is obtained, e.g. at the femoral vein, femoral artery, radial artery, subclavian artery, and an introducer guidewire is inserted. A guidewire is manipulated to reach the desired valve implantation site. Pre-shaped guidance catheters or balloon catheters may be used to facilitate the crossing of the valve implantation site
  • FIGS. 20A to 20D and 21A to 21B depicts an exemplary embodiment of the attachment interface 2000 of a delivery system that, for simplification, does not depict a steering or extension mechanism, that may be included.
  • the attachment interface 2000 comprises a proximal attachment interface 2002 and distal attachment interface 2004.
  • the proximal attachment interface 2002 comprises a proximal stator tube interface 2006, a drive shaft interface 2008
  • the distal attachment interface 2004 comprises a stator tube interface 2010 and a rotor shaft interface 2012 (depicted in FIG. 21A), coupled to the stator housing 2014 and the rotor shaft 2016, respectively.
  • the head/neck configuration is a slightly angled keystone or trapezoidal shape which correspond to the larger head and narrower neck regions, with an angle in the range of 1 to 10 degrees or 2 to 5 degrees, but in other variations, a greater angle up to 20 degrees, 30 degrees or 45 degrees may be provided.
  • the plurality of recesses 2050 of the drive shaft interface 2008 may comprise head and neck regions 2052, 2054, respectively, that form a complementary mechanical interfit with the neck and head regions 2058, 2060, respectively of the projections 2056 of the rotor shaft interface 2012.
  • the head and neck regions 2052, 2054, 2058, 2066 may also have angled sides so that the recesses 2032 and the projections 2038 may be engaged by transverse translation, but resist longitudinal separation once engaged.
  • FIG. 23 depicts multiple partial alignments and size differences to facilitate the seating of the distal attachment interface 2304 into the proximal attachment interface 2302, but some of the angular and size changes between the bi-directional embodiment in FIG. 22 and the unidirectional embodiment in FIG. 23 may cause, during torqueing of the delivery system, some mechanical bias or forces that may cause the proximal and distal attachment interfaces 2302, 2304 to twist apart or out of full alignment.
  • a subset of the alignment/seating features described in FIG. 23 may be implement, to achieve a different balance of between ease of seating, mechanical integrity and other factors.

Landscapes

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

Abstract

Des systèmes d'administration pour implants extensibles et à endoprothèse comprennent des éléments ajustables de mise sous tension qui commandent l'expansion de l'implant le long de la longueur de l'implant. Les éléments de mise sous tension sont enroulés sur un ou plusieurs rotors situés sur le segment distal du système de distribution, qui sont tournés pour dérouler les éléments de mise sous tension et qui étendent progressivement l'implant. Des mécanismes de positionnement sont également fournis afin d'ajuster la position et l'orientation de l'implant pendant la pose.
PCT/US2022/016042 2021-02-10 2022-02-10 Systèmes, dispositifs et procédés de systèmes d'administration WO2022173997A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP22753382.5A EP4291277A1 (fr) 2021-02-10 2022-02-10 Systèmes, dispositifs et procédés de systèmes d'administration
CN202280020414.3A CN117042828A (zh) 2021-02-10 2022-02-10 输送系统的系统、装置和方法
US18/264,626 US20240081991A1 (en) 2021-02-10 2022-02-10 Systems, devices and methods for delivery systems

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US202163148124P 2021-02-10 2021-02-10
US63/148,124 2021-02-10
US202163150518P 2021-02-17 2021-02-17
US63/150,518 2021-02-17
US17/179,308 2021-02-18
US17/179,308 US11246726B1 (en) 2021-02-10 2021-02-18 Systems, devices and methods for delivery systems
US202163178390P 2021-04-22 2021-04-22
US63/178,390 2021-04-22

Publications (1)

Publication Number Publication Date
WO2022173997A1 true WO2022173997A1 (fr) 2022-08-18

Family

ID=82837345

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2022/016042 WO2022173997A1 (fr) 2021-02-10 2022-02-10 Systèmes, dispositifs et procédés de systèmes d'administration

Country Status (2)

Country Link
EP (1) EP4291277A1 (fr)
WO (1) WO2022173997A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5904667A (en) * 1997-03-17 1999-05-18 C.R. Bard, Inc. Rotatable control mechanism for steerable catheter
US20050273151A1 (en) * 2004-06-04 2005-12-08 John Fulkerson Stent delivery system
US9572957B2 (en) * 2014-03-17 2017-02-21 Oscor Inc. Steerable medical devices and steering assemblies
US20180116689A1 (en) * 2015-10-30 2018-05-03 Terumo Kabushiki Kaisha Device handle for a medical device
US11246726B1 (en) * 2021-02-10 2022-02-15 Occam Labs LLC Systems, devices and methods for delivery systems

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5904667A (en) * 1997-03-17 1999-05-18 C.R. Bard, Inc. Rotatable control mechanism for steerable catheter
US20050273151A1 (en) * 2004-06-04 2005-12-08 John Fulkerson Stent delivery system
US9572957B2 (en) * 2014-03-17 2017-02-21 Oscor Inc. Steerable medical devices and steering assemblies
US20180116689A1 (en) * 2015-10-30 2018-05-03 Terumo Kabushiki Kaisha Device handle for a medical device
US11246726B1 (en) * 2021-02-10 2022-02-15 Occam Labs LLC Systems, devices and methods for delivery systems

Also Published As

Publication number Publication date
EP4291277A1 (fr) 2023-12-20

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