WO2018225059A1 - Double walled fixed length stent like apparatus and methods of use thereof - Google Patents

Double walled fixed length stent like apparatus and methods of use thereof Download PDF

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Publication number
WO2018225059A1
WO2018225059A1 PCT/IL2018/050604 IL2018050604W WO2018225059A1 WO 2018225059 A1 WO2018225059 A1 WO 2018225059A1 IL 2018050604 W IL2018050604 W IL 2018050604W WO 2018225059 A1 WO2018225059 A1 WO 2018225059A1
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WO
WIPO (PCT)
Prior art keywords
medical apparatus
tubular wall
tubular
elements
walls
Prior art date
Application number
PCT/IL2018/050604
Other languages
French (fr)
Inventor
Stephen F BELLOMO
Ben Adam Friesem
Tanhum Feld
Original Assignee
Restore Medical Ltd
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 Restore Medical Ltd filed Critical Restore Medical Ltd
Priority to CN201880036104.4A priority Critical patent/CN110691554B/en
Priority to EP18812772.4A priority patent/EP3624704A4/en
Priority to US16/616,465 priority patent/US11364132B2/en
Priority to IL271184A priority patent/IL271184B2/en
Publication of WO2018225059A1 publication Critical patent/WO2018225059A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/12036—Type of occlusion partial occlusion
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A61B17/12145—Coils or wires having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/852—Two or more distinct overlapping 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/068—Modifying the blood flow model, e.g. by diffuser or deflector
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91575—Adjacent bands being connected to each other connected peak to trough
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/001—Figure-8-shaped, e.g. hourglass-shaped
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
    • A61F2250/0063—Nested prosthetic parts

Definitions

  • the current invention relates to a medical device to be positioned within the main pulmonary artery and/or the pulmonary artery branches, and to methods of use thereof for treating, reducing the severity of, or reducing symptoms associated with, or any combination thereof, congestive heart failure, including left ventricular failure, wherein use may in certain embodiments, affect the position and function of the interventricular septum during systole.
  • CHF Congestive heart failure
  • systolic failure a reduced ability of the heart muscle to contract
  • diastolic failure a mechanical problem that limits the ability of the heart's chambers to fill with blood
  • LV left ventricle
  • CHF is a progressive disease. Failure of the left side of the heart (left-heart failure/left-sided failure/left- ventricle failure) is the most common form of the disease.
  • CHF affects people of all ages including children, but it occurs most frequently in those over age 60, and is the leading cause of hospitalization and death in that age group.
  • Current treatments of CHF include lifestyle changes, medications, and surgery to bypass blocked blood vessels, replace regurgitant or stenotic valves, install stents to open narrowed coronary vessels, install pump assist devices or transplantation of the heart.
  • Surgical pulmonary artery banding is a technique that was described more than 60 years ago and is still in use today for children and infants with congenital heart defects, such as overflow of blood to the lungs and volume overload of the RV.
  • PAB is typically performed through a thoracotomy and involves wrapping a band around the exterior of the main pulmonary artery (MP A) and fixing the band in place, often with the use of sutures. Once applied, the band is tightened, narrowing the diameter of the MPA, increasing resistance to flow, reducing blood flow to the lungs, and reducing downstream pulmonary artery (PA) pressure.
  • MP A main pulmonary artery
  • Surgical PAB procedures involve the risks present with all surgical procedures.
  • use of surgical PAB has a number of particular disadvantages and drawbacks.
  • Primary among these drawbacks is the inability of the surgeon performing the procedure to accurately assess, from the hemodynamic standpoint, the optimal final diameter to which the PA should be adjusted. Often, the surgeon must rely upon his or her experience in adjusting the band to achieve acceptable forward flow while decreasing the blood flow sufficiently to protect the pulmonary vasculature.
  • PAB left ventricle dilated cardiomyopathy
  • This method includes increasing the pressure load on the right ventricle by surgically placing a band around the pulmonary artery. The increased pressure in the right ventricle caused a leftward shift of the interventricular septum and improvement of left ventricle function. It was found that the optimal degree of constriction was achieved when the RV pressure was approximately 60% to 70% of the systemic level and so that the interventricular septum slightly moved to a midline position.
  • the MPA is not a favorable location for positioning an implant due to its relatively large diameter ( ⁇ 30mm) and short length ( ⁇ 50mm).
  • the full length of the MPA is not usable for an implant due to the proximity to the pulmonary valve on one end, and the bifurcation to the pulmonary branches on the other. It is estimated that the usable length of the MPA for the implant is approximately 30mm. Implantation of a short, wide device into the MPA is very difficult, and there is significant danger that the device will rotate or otherwise not be placed concentric with the MPA, in which case near complete blockage of the MPA could occur. In addition, the device may erroneously be placed either too close to the pulmonary valve or to the bifurcation.
  • the branch pulmonary arteries are more favorable for placement of an implant due to their smaller diameter than the MPA and the longer available length for placement of an implant.
  • implants When implants are placed in the branch PAs, it is required to place two implants in a bilateral fashion, in order to cause an increase in RV pressure.
  • the methods and apparatuses of the invention describe a medical apparatus configured to reduce a diameter of a blood vessel for treating or at least reducing the severity of a congestive failure of the heart, such as but not limited to: systolic heart failure, diastolic heart failure, left ventricle (LV) heart failure, right ventricle (RV) heart failure, congenital defects of the heart for which surgical pulmonary artery banding (PAB) is used, and any other condition which requires pulmonary artery banding (PAB).
  • systolic heart failure astolic heart failure
  • diastolic heart failure left ventricle (LV) heart failure
  • RV right ventricle
  • PAB pulmonary artery banding
  • PAB pulmonary artery banding
  • Some embodiments of the present invention provide a new medical apparatus for deployment within an anatomical blood vessel comprising:
  • the second tubular wall is configured to be partially constricted towards its inner radial axis, while maintaining its overall longitudinal length;
  • the combination of the first and second tubular walls forms a diametrical reducer.
  • the second tubular wall comprises plurality of section elements, wherein at least some of the sections elements are configured to allow a motion of at least some of the section elements one relative to another, when a constriction force is applied.
  • At least some of the section elements are configured to be deformed, when a constriction force is applied.
  • the plurality of section elements comprise strut elements and connecting elements; and wherein the connecting elements are configured to be deformed, when a constriction force is applied.
  • At least some of the section elements are arranged in rows or rings-like configuration.
  • the section elements' motion comprises at least one of: deformation, translation, rotation, twist, contraction, conversion and collapse.
  • At least one of the first- and the second- tubular walls comprises binding elements at its edges, configured for the connection of the first and the second tubular walls one to another.
  • the apparatus further comprising a constricting element configured to constrict a circumference of a portion of the second tubular wall.
  • the constriction provides the second tubular wall with a radial neck section, configured for reduction of the effective diameter of the anatomical blood vessel.
  • At least a portion of the second tubular wall is coated with a coating material.
  • the constriction is provided, while the medical apparatus is within the anatomic vessel.
  • the first and second tubular walls are concentric.
  • material of the first and second tubular walls comprises at least one of the group consisting of: Nitinol, stainless steel, Titanium, Cobalt-Chromium alloy, Tantalum alloy, polymer, Platinum alloy and any combination thereof
  • the first tubular wall is made of a first material and the second tubular wall is made of a second material.
  • the first and second tubular walls are manufactured by a laser cut process.
  • the ratio between the medical apparatus's longitudinal length and diameter of the first tubular wall is smaller than three (3).
  • the medical apparatus is reversibly collapsible and configured to be delivered into the anatomic vessel via a catheter.
  • Some embodiments of the present invention provide a new method of use of an apparatus configured for reduction of effective diameter of an anatomic vessel, the method comprising:
  • the step of providing comprises partially constricting the second tubular wall.
  • the step of providing comprises at least partially coating the second tubular wall.
  • the step of providing comprises connecting both the first- and the second- tubular walls at their edges, thereby restricting the first- and the second- tubular walls to have the same overall longitudinal length.
  • the step of deploying comprises delivering the medical apparatus into an anatomical blood vessel via a catheter.
  • FIG. 1 conceptually depicts a stent like medical apparatus having first and second tubular walls, according to some embodiments of the invention
  • FIGs. 2 A and 2B conceptually depict a flattened image and picture image of a second tubular wall, respectively, according to some embodiments of the invention
  • FIG. 3 conceptually depicts a first tubular wall, according to some embodiments of the invention.
  • FIG. 4 conceptually depicts a stent like medical apparatus, in a constricted configuration, according to some embodiments of the invention
  • FIG. 5A conceptually depicts a medical apparatus crimped within a delivery system, according to some embodiments of the invention.
  • FIG. 5B conceptually illustrates a crimped second tubular wall, according to some embodiments of the invention.
  • FIG.6A and 6B conceptually illustrate a non-limiting schematic example for a second tubular wall, according to some embodiments of the invention.
  • FIGs.6C and 6D conceptually illustrate non- limiting flattened schematic examples for second tubular walls, according to some embodiments of the invention.
  • FIG. 7 conceptually depicts a stent like medical apparatus having a first tubular wall and a second coated tubular wall, according to some embodiments of the invention.
  • Fig. 8 conceptually demonstrates a method of use of an apparatus configured for a reduction of an effective diameter of an anatomic vessel, according to some embodiments of the invention.
  • the term “about”, refers to a deviance of between 0.0001- 5% from the indicated number or range of numbers. In one embodiment, the term “about”, refers to a deviance of between 1 - 10% from the indicated number or range of numbers. In one embodiment, the term “about”, refers to a deviance of up to 25% from the indicated number or range of numbers.
  • the term “a” or “one” or “an” refers to at least one.
  • the present invention provides a stent like medical apparatus for deployment within an anatomical blood vessel, as demonstrated at least in Fig. 1, which is configured to reduce the effective diameter of an anatomical blood vessel.
  • the medical apparatus 100 comprises:
  • first tubular wall 110 also noted as outer tubular wall
  • second tubular wall 120 also noted as inner tubular wall, placed within the first tubular wall
  • first- and second- tubular walls are firmly connected (one to another) at their proximal- and distal- edges 131,132, therefore restricted to have same overall longitudinal length (L);
  • the second tubular wall is configured to be partially constricted 121 towards its inner radial axis, while maintaining its overall longitudinal length;
  • the constriction process may be applied after the deployment of the apparatus within an anatomical blood vessel.
  • the constriction is provided while the medical apparatus is within the anatomic vessel.
  • the constriction provides the second tubular wall with a radial neck section, configured for reduction of the effective diameter of the anatomical blood vessel.
  • at least a portion of the second tubular wall is coated with a coating material, as further demonstrated in Fig. 7, 760.
  • two bands of coating on the proximal and distal ends of the first tubular wall can be applied, configured to create a fluid seal with the coating of the second tubular wall, as further demonstrated in Fig. 7, 770.
  • the coating material can be selected, for a non-limiting example, from: silicone elastomers, urethane containing polymers (such as polyurethane, silicone-polyurethane, polycarbonate urethanes, and silicone polycarbonate urethanes), PTFE (polytetrafluoroethylene), ePTFE (expanded PTFE), PLA (including PLGA, PLLA), xenograft or allograft tissue (such as pericardial tissue).
  • silicone elastomers such as polyurethane, silicone-polyurethane, polycarbonate urethanes, and silicone polycarbonate urethanes
  • PTFE polytetrafluoroethylene
  • ePTFE expanded PTFE
  • PLA including PLGA, PLLA
  • xenograft or allograft tissue such as pericardial tissue.
  • the second tubular wall comprises a plurality of section elements, wherein at least some of the section elements are configured to allow a motion of at least some of the section elements one relative to another, when a constriction force is applied.
  • FIG. 2A illustrates a flattened second tubular wall, shown after the process of laser cutting, according to some embodiments of the invention.
  • Fig. 2B depicts a picture of a second tubular wall after constriction due to a constriction force (F), according to some embodiments of the invention.
  • F constriction force
  • the second tubular wall 220 comprises, according to some embodiments, a plurality of connected section elements 221, 222, wherein at least some of the section elements are configured to be deformed when a force, for example a constriction force (F), is applied thereon.
  • the deformed section elements allow a motion of some of the section elements one relative to another, therefore configured to allow a constriction of at least a part of the second tabular wall. Consequently, the deformed section elements allow the second tubular wall to expand its path length (Lp), during the radial constriction, while maintaining its overall longitudinal length (L).
  • the plurality of section elements can all have a similar shape and/or configuration. According to other embodiments the plurality of section elements can have a variety of shapes and/or configurations.
  • the plurality of section elements can comprise strut elements 221 and connecting elements 222, as demonstrated in Figs. 2A and 2B.
  • the connecting elements are configured to be deformed when a constriction force (F) is applied, and thereby configured to allow an increase in the distance between the strut elements rows/rings.
  • the deformation of the connecting elements consequently allows the constriction of at least a part of the second tubular wall, with an increased path length (Lp), while maintaining its overall longitudinal length (L).
  • the strut elements 222 can also be deformed by the constricting force, however in a much smaller deformation extent than of the connecting elements.
  • the increased distance between the strut elements is enabled by twisting of rows/rings of strut elements, one relative to the other via the connecting elements, as demonstrated by the marked arrows in the flattened schematic illustration in Fig. 2A.
  • the increased distance between the strut elements is enabled by extension of the connecting elements 622,632.
  • At least some of the section elements are arranged in rows or rings-like configuration 223.
  • the rings 223 are configured to move one relative to another, during the constriction.
  • the motion of the section elements comprises at least one of: translation, deformation, rotation, twist, contraction, conversion and collapse.
  • At least one of the first and the second tubular walls comprises binding elements 224,314 at its edges, configured for the connection of the first and the second tubular walls one to another.
  • the connection can be by a suture, adhesion, welding, mechanical connection, or any other means of connection.
  • Fig. 3 demonstrates a first tubular wall, according to some embodiments of the invention.
  • the first tubular wall 310 as demonstrated comprises binding elements 314 at its edges, configured for the connection of the first and the second tubular walls one to another.
  • the first tubular wall further comprises at least one grip element 340 (and 740, Fig. 7), at least at one edge thereof.
  • the grip element is configured to be pulled and thereby assist in loading the medical apparatus, for its insertion into a delivery system, as further demonstrated in Fig. 5A, and/or for re-sheathing of the apparatus into the delivery system during the process of deployment into the target vessel.
  • Fig. 4 demonstrates a medical apparatus 400 comprising the first tubular wall 410 and the second tubular wall 420 bound together at both their proximal and distal ends via their binding elements 414,424, and where the medical apparatus is shown in a partially constricted configuration
  • the apparatus further comprises a constricting element 430 configured to constrict a circumference of a portion of the second tubular wall 420.
  • the constriction of the second tubular wall can be provided before- and/or after- the deployment of the apparatus within the vessel; therefore, can be provided with an initial constricted state and/or constricted in real time to a final constricted state, respectively.
  • Figs. 5A and 5B demonstrate a stent-like medical apparatus 500, according to some embodiments of the invention.
  • the stent-like medical apparatus is configured for a reversible collapse and therefore configured to be delivered into the anatomic vessel via a catheter tube.
  • Fig.5A demonstrates the collapsed/crimped apparatus 500 within the delivery catheter 550
  • Fig. 5B demonstrates only the collapsed second tubular wall 520, within the delivery catheter 550, which is hidden by the first tubular wall at Fig. 5A.
  • the overall longitudinal length (Lc) of the collapsed/crimped apparatus is larger than the overall longitudinal length (L) of the non-collapsed apparatus, (Lc > L).
  • first and second tubular walls are the same whether in a crimped configuration (in a delivery catheter), a deployed configuration (in a vessel), or a constricted configuration (having an hourglass shape).
  • At least one of the outer and inner tubular walls is made of a collapsible memory shape material, therefore self-expanding material. According to some embodiments, at least one of the outer and inner tubular walls is manufactured by laser cut process.
  • the first and second tubular walls are concentric.
  • the medical apparatus is axisymmetric.
  • the material of the outer and inner tubular walls comprises at least one from the group consisting of: Nitinol, stainless steel, Titanium, Cobalt-Chromium alloy, Tantalum alloy, polymer (ePTFE, PU, etc.), Platinum alloy and any combination thereof.
  • the outer tubular wall is made of a first material and the inner tubular wall is made of a second material. According to some embodiments, the outer and inner tubular walls are made of the same material.
  • FIGs. 6A and 6B demonstrate a non-limiting schematic example for a second tubular wall 620 before (Fig. 6A) and after (Fig. 6B) its constriction.
  • the overall initial longitudinal length of the second tubular wall is 26mm and its initial diameter before its constriction is 15 mm.
  • a circumference constriction force (F) its minimal diameter is 10mm, while its overall longitudinal length is kept 26mm, such that the path length (L p ) of the second tubular wall has increased without an increase in its overall length (L).
  • the second tubular wall 625,635 comprises, according to some embodiments, a plurality of strut elements 621,631 and a plurality of connecting elements 622,632.
  • a constriction force F
  • at least some of the connecting elements are configured to be deformed and cause an increase in the distance between the strut elements rows/rings, therefore allowing a constriction of at least a part of the second tabular wall, with an increased path length, while maintaining its overall longitudinal length.
  • the rows or rings-like configurations 623,633 are also demonstrated.
  • Fig. 7 conceptually depicts a stent like medical apparatus 700 having a first tubular wall and a second coated tubular wall.
  • the medical apparatus 700 comprises:
  • first tubular wall 710 also noted as outer tubular wall
  • second tubular wall 720 (also noted as inner tubular wall), placed within the first tubular wall;
  • first- and second- tubular walls are firmly connected at their proximal and distal edges 714,724, therefore restricted to have same overall longitudinal length;
  • the second tubular wall is configured to be partially constricted 730 towards its inner radial axis, while maintaining its overall longitudinal length;
  • Fig. 7 further demonstrates that at least a portion of the second tubular wall 720 is coated with a coating material 760, for example by an ePTFE, such that the flow through the vessel will be guided through the second tubular wall.
  • Fig. 7 further demonstrates that in addition to the coating of the second tubular wall, the proximal and distal ends of the first tubular wall can be coated 770, according to some embodiments of the invention, to create a fluid seal with the coating of the second tubular wall.
  • FIG. 8 conceptually demonstrates a method of use of an apparatus configured for a reduction of an effective diameter of an anatomic vessel, according to any of the above-mentioned embodiments.
  • the method 800 comprising:
  • - constricting 830 at least a portion of the second tubular wall, thereby providing the second tubular wall with a radial neck section, while maintaining its overall longitudinal length.
  • the step of providing further comprises partially constricting 811 the second tubular wall to an initial constricted state, which may be further constricted.
  • the initial constriction is provided via a heating process; for example, by heat treatment of the Nitinol of the second tubular wall to maintain a specific shape; for example, to have a shape of an hourglass.
  • the step of providing further comprises at least partially coating 812 the second tubular wall.
  • the step of providing further comprises connecting 813 both the first- and the second- tubular walls at their edges, thereby restricting the first- and the second- tubular walls to have the same overall longitudinal length.
  • the step of deploying comprises delivering 821 the medical apparatus into an anatomical blood vessel via a catheter, wherein the medical apparatus is provided in a crimped configuration, which is configured to expand back, once deployed out of the delivering catheter.
  • a therapeutic result for the use of a medical apparatus as mentioned above, for patients with LV heart failure can be at least one of the group consisting of:
  • LVEF left ventricle ejection fraction
  • LEDP left ventricle end diastolic pressure

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Abstract

A new medical apparatus for deployment within an anatomical blood vessel and methods of use thereof The apparatus comprising: a first tubular wall; and a second tubular wall, placed within the first tubular wall; wherein the first and second tubular walls are firmly connected at their edges, therefore restricted to have same overall longitudinal length; and wherein the second tubular wall is configured to be partially constricted towards its inner radial axis, while maintaining its overall longitudinal length.

Description

DOUBLE WALLED FIXED LENGTH STENT LIKE APPARATUS
AND METHODS OF USE THEREOF
FIELD OF THE INVENTION
[001 ] The current invention relates to a medical device to be positioned within the main pulmonary artery and/or the pulmonary artery branches, and to methods of use thereof for treating, reducing the severity of, or reducing symptoms associated with, or any combination thereof, congestive heart failure, including left ventricular failure, wherein use may in certain embodiments, affect the position and function of the interventricular septum during systole.
BACKGROUND OF THE INVENTION
[002] Congestive heart failure (CHF) is a condition in which the heart does not pump out sufficient blood to meet the body's demands. CHF can result from either a reduced ability of the heart muscle to contract (systolic failure) or from a mechanical problem that limits the ability of the heart's chambers to fill with blood (diastolic failure). When weakened, the heart is unable to keep up with the demands placed upon it and the left ventricle (LV) may get backed up or congested. CHF is a progressive disease. Failure of the left side of the heart (left-heart failure/left-sided failure/left- ventricle failure) is the most common form of the disease.
[003] CHF affects people of all ages including children, but it occurs most frequently in those over age 60, and is the leading cause of hospitalization and death in that age group. Current treatments of CHF include lifestyle changes, medications, and surgery to bypass blocked blood vessels, replace regurgitant or stenotic valves, install stents to open narrowed coronary vessels, install pump assist devices or transplantation of the heart.
[004] Normal cardiac contraction is a finely tuned orchestrated activity dependent on muscle function, ventricular geometry and loading conditions termed preload and afterload. When CHF due to LV systolic failure occurs it is typically associated with changes in the geometry of the ventricles, often called remodeling. The LV becomes dilated and the interventricular septum is deflected into the right ventricle (RV), resulting in decreased LV output/pumping efficiency. The efficient systolic function of the LV is dependent not only on the strength of the myocardium but also on the LV geometry, the position and shape of the interventricular septum and the geometry and function of the RV. Interventricular dependence has been documented in experimental studies which have evaluated both normal and pathological preparations in animals. LV systolic function can be directly influenced by interventions affecting the RV and the position of the interventricular septum.
[005] Surgical pulmonary artery banding (PAB) is a technique that was described more than 60 years ago and is still in use today for children and infants with congenital heart defects, such as overflow of blood to the lungs and volume overload of the RV. PAB is typically performed through a thoracotomy and involves wrapping a band around the exterior of the main pulmonary artery (MP A) and fixing the band in place, often with the use of sutures. Once applied, the band is tightened, narrowing the diameter of the MPA, increasing resistance to flow, reducing blood flow to the lungs, and reducing downstream pulmonary artery (PA) pressure.
[006] Surgical PAB procedures involve the risks present with all surgical procedures. In addition, use of surgical PAB has a number of particular disadvantages and drawbacks. Primary among these drawbacks is the inability of the surgeon performing the procedure to accurately assess, from the hemodynamic standpoint, the optimal final diameter to which the PA should be adjusted. Often, the surgeon must rely upon his or her experience in adjusting the band to achieve acceptable forward flow while decreasing the blood flow sufficiently to protect the pulmonary vasculature.
[007] It is also not uncommon for the band to migrate towards one of the pulmonary artery branches (usually the left), resulting in stenosis of the other pulmonary artery branch (usually the right). There have also been reports of hardening of the vessels around the band due to buildup of calcium deposits and scarring of the PA wall beneath the band, which can also inhibit blood flow. Flow resistance due to PAB may change over time, and additional surgeries to adjust band tightness occur in up to one third of patients. The band is typically removed in a subsequent operation, for example, when a congenital malformation is corrected in the child or infant.
[008] In addition to the classical use of PAB for treatment of congenital defects in infants and children, there has been a recent report of use of surgical PAB for left ventricle dilated cardiomyopathy (LVDCM) in infants and young children. This method includes increasing the pressure load on the right ventricle by surgically placing a band around the pulmonary artery. The increased pressure in the right ventricle caused a leftward shift of the interventricular septum and improvement of left ventricle function. It was found that the optimal degree of constriction was achieved when the RV pressure was approximately 60% to 70% of the systemic level and so that the interventricular septum slightly moved to a midline position. The success of these procedures in infants and children has been reported to be possibly due to the potential for myocyte recovery and repopulation being significantly greater for infants and young children than for adults. However, it is the position of the inventors that the geometric improvements to the failing heart due to PAB may be responsible, at least partially, for the observed improvements in LV function, and therefore PAB for adult left ventricle heart failure may demonstrate similar improvement in LV function.
[009] The MPA is not a favorable location for positioning an implant due to its relatively large diameter (~30mm) and short length (~50mm). The full length of the MPA is not usable for an implant due to the proximity to the pulmonary valve on one end, and the bifurcation to the pulmonary branches on the other. It is estimated that the usable length of the MPA for the implant is approximately 30mm. Implantation of a short, wide device into the MPA is very difficult, and there is significant danger that the device will rotate or otherwise not be placed concentric with the MPA, in which case near complete blockage of the MPA could occur. In addition, the device may erroneously be placed either too close to the pulmonary valve or to the bifurcation. The branch pulmonary arteries are more favorable for placement of an implant due to their smaller diameter than the MPA and the longer available length for placement of an implant. When implants are placed in the branch PAs, it is required to place two implants in a bilateral fashion, in order to cause an increase in RV pressure.
[0010] Accordingly, there is a need to provide a relatively simple medical apparatus, which could be implanted in a minimally-invasive fashion, and which can allow an adjustment of blood flow through a vessel. There is also a need for gradual reduction in the diameter of the MPA or branch PAs, which is not currently feasible with the surgical PAB approaches described above. In addition, there is a need to use the medical apparatus for treatment of the mature adult population suffering from left ventricle (LV) failure.
SUMMARY OF THE INVENTION
[0011] The methods and apparatuses of the invention describe a medical apparatus configured to reduce a diameter of a blood vessel for treating or at least reducing the severity of a congestive failure of the heart, such as but not limited to: systolic heart failure, diastolic heart failure, left ventricle (LV) heart failure, right ventricle (RV) heart failure, congenital defects of the heart for which surgical pulmonary artery banding (PAB) is used, and any other condition which requires pulmonary artery banding (PAB).
[0012] Some embodiments of the present invention provide a new medical apparatus for deployment within an anatomical blood vessel comprising:
- a first tubular wall; and
- a second tubular wall, placed within the first tubular wall; wherein the first and second tubular walls are firmly connected at their edges, therefore restricted to have same overall longitudinal length (L); and
wherein the second tubular wall is configured to be partially constricted towards its inner radial axis, while maintaining its overall longitudinal length;
accordingly, the combination of the first and second tubular walls forms a diametrical reducer.
[0013] In some embodiments, the second tubular wall comprises plurality of section elements, wherein at least some of the sections elements are configured to allow a motion of at least some of the section elements one relative to another, when a constriction force is applied.
[0014] In some embodiments, at least some of the section elements are configured to be deformed, when a constriction force is applied.
[0015] In some embodiments, the plurality of section elements comprise strut elements and connecting elements; and wherein the connecting elements are configured to be deformed, when a constriction force is applied.
[0016] In some embodiments, at least some of the section elements are arranged in rows or rings-like configuration.
[0017] In some embodiments, the section elements' motion comprises at least one of: deformation, translation, rotation, twist, contraction, conversion and collapse.
[0018] In some embodiments, at least one of the first- and the second- tubular walls comprises binding elements at its edges, configured for the connection of the first and the second tubular walls one to another.
[0019] In some embodiments, the apparatus further comprising a constricting element configured to constrict a circumference of a portion of the second tubular wall.
[0020] In some embodiments, the constriction provides the second tubular wall with a radial neck section, configured for reduction of the effective diameter of the anatomical blood vessel.
[0021] In some embodiments, at least a portion of the second tubular wall is coated with a coating material.
[0022] In some embodiments, the constriction is provided, while the medical apparatus is within the anatomic vessel. [0023] In some embodiments, the first and second tubular walls are concentric.
[0024] In some embodiments, material of the first and second tubular walls comprises at least one of the group consisting of: Nitinol, stainless steel, Titanium, Cobalt-Chromium alloy, Tantalum alloy, polymer, Platinum alloy and any combination thereof
[0025] In some embodiments, the first tubular wall is made of a first material and the second tubular wall is made of a second material.
[0026] In some embodiments, the first and second tubular walls are manufactured by a laser cut process.
[0027] In some embodiments, the ratio between the medical apparatus's longitudinal length and diameter of the first tubular wall is smaller than three (3).
[0028] In some embodiments, the medical apparatus is reversibly collapsible and configured to be delivered into the anatomic vessel via a catheter.
[0029] Some embodiments of the present invention provide a new method of use of an apparatus configured for reduction of effective diameter of an anatomic vessel, the method comprising:
- providing a medical apparatus having a second tubular wall placed within a first tubular wall;
- deploying the medical apparatus within an anatomical blood vessel; and
- constricting at least a portion of the second tubular wall, thereby providing the second tubular wall with a radial neck section, while maintaining its overall longitudinal length.
[0030] In some embodiments, the step of providing comprises partially constricting the second tubular wall.
[0031] In some embodiments, the step of providing comprises at least partially coating the second tubular wall.
[0032] In some embodiments, the step of providing comprises connecting both the first- and the second- tubular walls at their edges, thereby restricting the first- and the second- tubular walls to have the same overall longitudinal length.
[0033] In some embodiments, the step of deploying comprises delivering the medical apparatus into an anatomical blood vessel via a catheter. BRIEF DESCRIPTION OF THE DRAWINGS
[0034] The subject matter regarded as the invention is particularly pointed out and distinctly claimed in the concluding portion of the specification. The invention, however, both as to organization and method of operation, together with objects, features, and advantages thereof, may be understood by reference to the following detailed description when read with the accompanying drawings in which:
[0035] Fig. 1 conceptually depicts a stent like medical apparatus having first and second tubular walls, according to some embodiments of the invention;
[0036] Figs. 2 A and 2B conceptually depict a flattened image and picture image of a second tubular wall, respectively, according to some embodiments of the invention;
[0037] Fig. 3 conceptually depicts a first tubular wall, according to some embodiments of the invention;
[0038] Fig. 4 conceptually depicts a stent like medical apparatus, in a constricted configuration, according to some embodiments of the invention;
[0039] Fig. 5A conceptually depicts a medical apparatus crimped within a delivery system, according to some embodiments of the invention;
[0040] Fig. 5B conceptually illustrates a crimped second tubular wall, according to some embodiments of the invention;
[0041 ] Figs.6A and 6B conceptually illustrate a non-limiting schematic example for a second tubular wall, according to some embodiments of the invention;
[0042] Figs.6C and 6D conceptually illustrate non- limiting flattened schematic examples for second tubular walls, according to some embodiments of the invention;
[0043] Fig. 7 conceptually depicts a stent like medical apparatus having a first tubular wall and a second coated tubular wall, according to some embodiments of the invention; and
[0044] Fig. 8 conceptually demonstrates a method of use of an apparatus configured for a reduction of an effective diameter of an anatomic vessel, according to some embodiments of the invention.
[0045] It will be appreciated that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements. DETAILED DESCRIPTION OF THE PRESENT INVENTION
[0046] The following description is provided, alongside all chapters of the present invention, so that to enable any person skilled in the art to make use of the invention and sets forth the best modes contemplated by the inventor of carrying out this invention Various modifications, however, will remain apparent to those skilled in the art, since the generic principles of the present invention have been defined specifically to provide a medical apparatus configured to reduce a diameter of a blood vessel for treating or at least reducing the severity of a congestive failure of the heart, such as but not limited to: systolic heart failure, diastolic heart failure, left ventricle (LV) heart failure, right ventricle (RV) heart failure, congenital defects of the heart for which surgical pulmonary artery banding (PAB) is used, and any other condition which requires pulmonary artery banding (PAB).
[0047] As used herein, in one embodiment, the term "about", refers to a deviance of between 0.0001- 5% from the indicated number or range of numbers. In one embodiment, the term "about", refers to a deviance of between 1 - 10% from the indicated number or range of numbers. In one embodiment, the term "about", refers to a deviance of up to 25% from the indicated number or range of numbers.
[0048] According to some embodiments, the term "a" or "one" or "an" refers to at least one.
[0049] According to some embodiments the present invention provides a stent like medical apparatus for deployment within an anatomical blood vessel, as demonstrated at least in Fig. 1, which is configured to reduce the effective diameter of an anatomical blood vessel.
[0050] According to some embodiments, the medical apparatus 100 comprises:
- a first tubular wall 110 (also noted as outer tubular wall); and
- a second tubular wall 120 (also noted as inner tubular wall), placed within the first tubular wall;
wherein the first- and second- tubular walls are firmly connected (one to another) at their proximal- and distal- edges 131,132, therefore restricted to have same overall longitudinal length (L); and
wherein the second tubular wall is configured to be partially constricted 121 towards its inner radial axis, while maintaining its overall longitudinal length;
it is therefore that the combination of the first and second tubular walls forms a diametrical reducer.
[0051] According to some embodiments, the constriction process may be applied after the deployment of the apparatus within an anatomical blood vessel.
[0052] According to some embodiments, the constriction is provided while the medical apparatus is within the anatomic vessel. According to some embodiments, the constriction provides the second tubular wall with a radial neck section, configured for reduction of the effective diameter of the anatomical blood vessel. According to some embodiments, at least a portion of the second tubular wall is coated with a coating material, as further demonstrated in Fig. 7, 760.
[0053] According to some embodiments, in addition to the coating of the second tubular wall, two bands of coating on the proximal and distal ends of the first tubular wall can be applied, configured to create a fluid seal with the coating of the second tubular wall, as further demonstrated in Fig. 7, 770.
[0054] The coating material can be selected, for a non-limiting example, from: silicone elastomers, urethane containing polymers (such as polyurethane, silicone-polyurethane, polycarbonate urethanes, and silicone polycarbonate urethanes), PTFE (polytetrafluoroethylene), ePTFE (expanded PTFE), PLA (including PLGA, PLLA), xenograft or allograft tissue (such as pericardial tissue).
[0055] According to some embodiments, the second tubular wall comprises a plurality of section elements, wherein at least some of the section elements are configured to allow a motion of at least some of the section elements one relative to another, when a constriction force is applied.
[0056] Reference is now made to Figs.2 A and 2B, which schematically demonstrate a second tubular wall, according to some embodiments of the invention. Fig. 2A illustrates a flattened second tubular wall, shown after the process of laser cutting, according to some embodiments of the invention. Fig. 2B depicts a picture of a second tubular wall after constriction due to a constriction force (F), according to some embodiments of the invention.
[0057] As shown in both Figs. 2A and 2B the second tubular wall 220 comprises, according to some embodiments, a plurality of connected section elements 221, 222, wherein at least some of the section elements are configured to be deformed when a force, for example a constriction force (F), is applied thereon. The deformed section elements allow a motion of some of the section elements one relative to another, therefore configured to allow a constriction of at least a part of the second tabular wall. Consequently, the deformed section elements allow the second tubular wall to expand its path length (Lp), during the radial constriction, while maintaining its overall longitudinal length (L).
[0058] According to some embodiments the plurality of section elements can all have a similar shape and/or configuration. According to other embodiments the plurality of section elements can have a variety of shapes and/or configurations. [0059] According to some embodiments, the plurality of section elements can comprise strut elements 221 and connecting elements 222, as demonstrated in Figs. 2A and 2B. The connecting elements are configured to be deformed when a constriction force (F) is applied, and thereby configured to allow an increase in the distance between the strut elements rows/rings. The deformation of the connecting elements consequently allows the constriction of at least a part of the second tubular wall, with an increased path length (Lp), while maintaining its overall longitudinal length (L). According to some embodiments, the strut elements 222 can also be deformed by the constricting force, however in a much smaller deformation extent than of the connecting elements.
[0060] In the examples of Figs. 2A and 2B, the increased distance between the strut elements is enabled by twisting of rows/rings of strut elements, one relative to the other via the connecting elements, as demonstrated by the marked arrows in the flattened schematic illustration in Fig. 2A. In other embodiments, and as demonstrated in Figs. 6C and 6D, the increased distance between the strut elements is enabled by extension of the connecting elements 622,632.
[0061] According to some embodiments, at least some of the section elements are arranged in rows or rings-like configuration 223. The rings 223 are configured to move one relative to another, during the constriction.
[0062] According to some embodiments, the motion of the section elements comprises at least one of: translation, deformation, rotation, twist, contraction, conversion and collapse.
[0063] According to some embodiments, at least one of the first and the second tubular walls comprises binding elements 224,314 at its edges, configured for the connection of the first and the second tubular walls one to another. According to some embodiments, the connection can be by a suture, adhesion, welding, mechanical connection, or any other means of connection.
[0064] Reference is now made to Fig. 3, which demonstrates a first tubular wall, according to some embodiments of the invention. The first tubular wall 310 as demonstrated comprises binding elements 314 at its edges, configured for the connection of the first and the second tubular walls one to another. According to some embodiments the first tubular wall further comprises at least one grip element 340 (and 740, Fig. 7), at least at one edge thereof. The grip element is configured to be pulled and thereby assist in loading the medical apparatus, for its insertion into a delivery system, as further demonstrated in Fig. 5A, and/or for re-sheathing of the apparatus into the delivery system during the process of deployment into the target vessel.
[0065] Reference is now made to Fig. 4, which demonstrates a medical apparatus 400 comprising the first tubular wall 410 and the second tubular wall 420 bound together at both their proximal and distal ends via their binding elements 414,424, and where the medical apparatus is shown in a partially constricted configuration According to some embodiments, the apparatus further comprises a constricting element 430 configured to constrict a circumference of a portion of the second tubular wall 420.
[0066] According to some embodiments the constriction of the second tubular wall can be provided before- and/or after- the deployment of the apparatus within the vessel; therefore, can be provided with an initial constricted state and/or constricted in real time to a final constricted state, respectively.
[0067] Reference is now made to Figs. 5A and 5B, which demonstrate a stent-like medical apparatus 500, according to some embodiments of the invention. As demonstrated the stent-like medical apparatus is configured for a reversible collapse and therefore configured to be delivered into the anatomic vessel via a catheter tube. Fig.5A demonstrates the collapsed/crimped apparatus 500 within the delivery catheter 550, whereas Fig. 5B demonstrates only the collapsed second tubular wall 520, within the delivery catheter 550, which is hidden by the first tubular wall at Fig. 5A. According to some embodiments, the overall longitudinal length (Lc) of the collapsed/crimped apparatus is larger than the overall longitudinal length (L) of the non-collapsed apparatus, (Lc > L).
[0068] According to some embodiments, the overall longitudinal lengths of first and second tubular walls are the same whether in a crimped configuration (in a delivery catheter), a deployed configuration (in a vessel), or a constricted configuration (having an hourglass shape).
[0069] According to some embodiments, at least one of the outer and inner tubular walls is made of a collapsible memory shape material, therefore self-expanding material. According to some embodiments, at least one of the outer and inner tubular walls is manufactured by laser cut process.
[0070] According to some embodiments, the ratio N (N = U Dout) between the medical apparatus's 100 longitudinal length (L), as demonstrated in Fig. 1 , and the diameter of the outer tubular wall (Dout) is smaller than a predetermined numeral selected from the group consisting of: 3, 2.5, 2, 1.5, 1, 0.5, 0.3 and any ratio within their range. According to a preferred embodiment, N is smaller than 1.5.
[0071] According to some embodiments, the first and second tubular walls are concentric. According to some embodiments, the medical apparatus is axisymmetric.
[0072] According to some embodiments, the material of the outer and inner tubular walls comprises at least one from the group consisting of: Nitinol, stainless steel, Titanium, Cobalt-Chromium alloy, Tantalum alloy, polymer (ePTFE, PU, etc.), Platinum alloy and any combination thereof. [0073] According to some embodiments, the outer tubular wall is made of a first material and the inner tubular wall is made of a second material. According to some embodiments, the outer and inner tubular walls are made of the same material.
[0074] Reference is now made to Figs. 6A and 6B, which demonstrate a non-limiting schematic example for a second tubular wall 620 before (Fig. 6A) and after (Fig. 6B) its constriction. In this non-limiting example, the overall initial longitudinal length of the second tubular wall is 26mm and its initial diameter before its constriction is 15 mm. After a partial constriction of the second tubular wall, by applying a circumference constriction force (F) its minimal diameter is 10mm, while its overall longitudinal length is kept 26mm, such that the path length (Lp) of the second tubular wall has increased without an increase in its overall length (L).
[0075] Reference is now made to Figs. 6C and 6D, which schematically demonstrate two different non-limiting flattened schematic examples for second tubular walls, according to some embodiments of the invention. As shown, the second tubular wall 625,635 comprises, according to some embodiments, a plurality of strut elements 621,631 and a plurality of connecting elements 622,632. When a constriction force (F) is applied, at least some of the connecting elements are configured to be deformed and cause an increase in the distance between the strut elements rows/rings, therefore allowing a constriction of at least a part of the second tabular wall, with an increased path length, while maintaining its overall longitudinal length. The rows or rings-like configurations 623,633 are also demonstrated.
[0076] Reference is now made to Fig. 7, which conceptually depicts a stent like medical apparatus 700 having a first tubular wall and a second coated tubular wall. According to some embodiments of the invention the medical apparatus 700 comprises:
- a first tubular wall 710 (also noted as outer tubular wall); and
- a second tubular wall 720 (also noted as inner tubular wall), placed within the first tubular wall;
wherein the first- and second- tubular walls are firmly connected at their proximal and distal edges 714,724, therefore restricted to have same overall longitudinal length; and
wherein the second tubular wall is configured to be partially constricted 730 towards its inner radial axis, while maintaining its overall longitudinal length;
it is therefore that the combination of the first and second tubular walls forms a diametrical reducer.
[0077] Fig. 7 further demonstrates that at least a portion of the second tubular wall 720 is coated with a coating material 760, for example by an ePTFE, such that the flow through the vessel will be guided through the second tubular wall. Fig. 7 further demonstrates that in addition to the coating of the second tubular wall, the proximal and distal ends of the first tubular wall can be coated 770, according to some embodiments of the invention, to create a fluid seal with the coating of the second tubular wall.
[0078] Reference is now made to Fig. 8, which conceptually demonstrates a method of use of an apparatus configured for a reduction of an effective diameter of an anatomic vessel, according to any of the above-mentioned embodiments. The method 800 comprising:
- providing 810 a medical apparatus having a second tubular wall placed within a first tubular wall;
- deploying 820 the medical apparatus within an anatomical blood vessel; and
- constricting 830 at least a portion of the second tubular wall, thereby providing the second tubular wall with a radial neck section, while maintaining its overall longitudinal length.
[0079] According to some embodiments, the step of providing further comprises partially constricting 811 the second tubular wall to an initial constricted state, which may be further constricted. According to some embodiments, the initial constriction is provided via a heating process; for example, by heat treatment of the Nitinol of the second tubular wall to maintain a specific shape; for example, to have a shape of an hourglass.
[0080] According to some embodiments, the step of providing further comprises at least partially coating 812 the second tubular wall.
[0081] According to some embodiments, the step of providing further comprises connecting 813 both the first- and the second- tubular walls at their edges, thereby restricting the first- and the second- tubular walls to have the same overall longitudinal length.
[0082] According to some embodiments, the step of deploying comprises delivering 821 the medical apparatus into an anatomical blood vessel via a catheter, wherein the medical apparatus is provided in a crimped configuration, which is configured to expand back, once deployed out of the delivering catheter.
[0083] According to some embodiments, a therapeutic result for the use of a medical apparatus as mentioned above, for patients with LV heart failure, can be at least one of the group consisting of:
- an increase in the left ventricle ejection fraction (LVEF); - a decrease in the left ventricle end diastolic pressure (LVEDP);
- improvement in the clinical symptoms of heart failure; and
- any combination thereof
[0084] While certain features of the invention have been illustrated and described herein, many modifications, substitutions, changes, and equivalents will now occur to those of ordinary skill in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.

Claims

1. A medical apparatus for deployment within an anatomical blood vessel comprising:
- a first tubular wall; and
- a second tubular wall, placed within the first tubular wall;
wherein the first and second tubular walls are firmly connected at their edges, therefore restricted to have same overall longitudinal length (L); and
wherein the second tubular wall is configured to be partially constricted towards its inner radial axis, while maintaining its overall longitudinal length;
the combination of the first and second tubular walls forms a diametrical reducer.
2. The medical apparatus of claim 1 , wherein the second tubular wall comprises plurality of section elements, wherein at least some of the sections elements are configured to allow a motion of at least some of the section elements one relative to another, when a constriction force is applied.
3. The medical apparatus of claim 2, wherein at least some of the section elements are configured to be deformed, when a constriction force is applied.
4. The medical apparatus of claim 2, wherein the plurality of section elements comprise strut elements and connecting elements; and wherein the connecting elements are configured to be deformed, when a constriction force is applied.
5. The medical apparatus of any one of claims 2 to 4, wherein at least some of the section elements are arranged in rows or rings-like configuration.
6. The medical apparatus of any one of claims 2 to 5, wherein the section elements' motion comprises at least one of: deformation, translation, rotation, twist, contraction, conversion and collapse.
7. The medical apparatus of any one of claims 1 to 6, wherein at least one of the first- and the second- tubular walls comprises binding elements at its edges, configured for the connection of the first and the second tubular walls one to another.
8. The medical apparatus of any one of claims 1 to 7, further comprising a constricting element configured to constrict a circumference of a portion of the second tubular wall.
9. The medical apparatus of any one of claims 1 to 8, wherein the constriction provides the second tubular wall with a radial neck section, configured for reduction of the effective diameter of the anatomical blood vessel.
10. The medical apparatus of any one of claims 1 to 9, wherein at least a portion of the second tubular wall is coated with a coating material.
11. The medical apparatus of any one of claims 1 to 10, wherein the constriction is provided, while the medical apparatus is within the anatomic vessel.
12. The medical apparatus of any one of claims 1 to 11, wherein the first and second tubular walls are concentric.
13. The medical apparatus of anyone of claims 1 to 12, wherein material of the first and second tubular walls comprises at least one of the group consisting of: Nitinol, stainless steel, Titanium, Cobalt-Chromium alloy, Tantalum alloy, polymer, Platinum alloy and any combination thereof.
14. The medical apparatus of any one of claims 1 to 13, wherein the first tubular wall is made of a first material and the second tubular wall is made of a second material.
15. The medical apparatus of any one of claims 1 to 14, wherein the first and second tubular walls are manufactured by a laser cut process.
16. The medical apparatus of any one of claims 1 to 15, wherein the ratio between the medical apparatus's longitudinal length and diameter of the first tubular wall is smaller than three (3).
17. The medical apparatus of any one of claims 1 to 16, wherein the medical apparatus is reversibly collapsible and configured to be delivered into the anatomic vessel via a catheter.
18. A method of use of an apparatus configured for reduction of effective diameter of an anatomic vessel, the method comprising:
- providing a medical apparatus having a second tubular wall placed within a first tubular wall;
- deploying the medical apparatus within an anatomical blood vessel; and
- constricting at least a portion of the second tubular wall, thereby providing the second tubular wall with a radial neck section, while maintaining its overall longitudinal length.
19. The method of claim 18, wherein the step of providing comprises partially constricting the second tubular wall. The method of any one of claims 18 to 19, wherein the step of providing comprises at least partially coating the second tubular wall.
The method of any one of claims 18 to 20, wherein the step of providing comprises connecting both the first- and the second- tubular walls at their edges, thereby restricting the first- and the second- tubular walls to have the same overall longitudinal length.
The method of any one of claims 18 to 21, wherein the step of deploying comprises delivering the medical apparatus into an anatomical blood vessel via a catheter.
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US16/616,465 US11364132B2 (en) 2017-06-05 2018-06-04 Double walled fixed length stent like apparatus and methods of use thereof
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US11364132B2 (en) 2022-06-21

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