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WO2025012896A2 - Écarteur d'épaule - Google Patents

Écarteur d'épaule Download PDF

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Publication number
WO2025012896A2
WO2025012896A2 PCT/IL2024/050665 IL2024050665W WO2025012896A2 WO 2025012896 A2 WO2025012896 A2 WO 2025012896A2 IL 2024050665 W IL2024050665 W IL 2024050665W WO 2025012896 A2 WO2025012896 A2 WO 2025012896A2
Authority
WO
WIPO (PCT)
Prior art keywords
shoulder
shoulder spacer
spacer according
protrusions
exemplary
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/IL2024/050665
Other languages
English (en)
Other versions
WO2025012896A3 (fr
Inventor
Assaf Dekel
Eran GANZ
Joseph Hilel NATHAN
Maoz SHEMESH
Daniel ANAVI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Voll Medical Technologies Ltd
Original Assignee
Voll Medical Technologies 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 Voll Medical Technologies Ltd filed Critical Voll Medical Technologies Ltd
Publication of WO2025012896A2 publication Critical patent/WO2025012896A2/fr
Publication of WO2025012896A3 publication Critical patent/WO2025012896A3/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61F2/30—Joints
    • A61F2/40—Joints for shoulders
    • 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
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30011—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in porosity
    • 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
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • 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
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • A61F2002/30064—Coating or prosthesis-covering structure made of biodegradable material
    • 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
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30581—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid
    • 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
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30581—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid
    • A61F2002/30584—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid filled with gas
    • 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
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30593—Special structural features of bone or joint prostheses not otherwise provided for hollow
    • 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
    • A61F2/30—Joints
    • A61F2/30721—Accessories
    • A61F2002/30754—Implants for interposition between two natural articular surfaces
    • 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
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772—Apertures or holes, e.g. of circular cross section
    • A61F2002/30784—Plurality of holes
    • 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
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/3092—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored structure
    • 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
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30971—Laminates, i.e. layered products
    • 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
    • A61F2/30—Joints
    • A61F2/40—Joints for shoulders
    • A61F2002/4088—Acromial components

Definitions

  • the present invention in some embodiments thereof, relates to a shoulder spacer and, more particularly, but not exclusively, to a stable and reliable shoulder spacer.
  • Rotator Cuff Tear is a common injury among ⁇ 2 million people in the US annually. About 1 million requires a surgical intervention and classified to four categories of tear severity: Small, Medium, Large or Massive. Massive tears are cases that involves 2 or more tendons (in most cases, the superior tendons) with 5 cm distance or more between the torn edge and the humeral head, where of the one million RCT patients, 25-30% are massive tear cases (15-20% irreparable and 10% reparable).
  • U.S. Patent No. US8753390B2 disclosing a prosthesis for reducing injury to soft tissues of the body, comprising an implantable member adapted to simulate at least one of a size or a shape of a naturally occurring bursa, where the member may be inflatable or otherwise expandable, flexible or rigid, and may be composed of a biocompatible, biodegradable, or non-biodegradable material.
  • the member is adapted to be implanted at a musculoskeletal attachment site or at a site between a muscle and a bone, and is shaped and sized to reduce injury to the site.
  • the prosthesis may also include a plug which seals the prosthesis automatically upon removal of an inflation tube.
  • U.S. Patent Application Publication No. US20110295379A1 disclosing a soft, expandable, implantable device sized for spacing between small bones comprising a first smooth surface on which a first small bone may slide.
  • the implant includes an opening (passage) extending through the device for promoting fibrotic development through the opening from a direction from both thumb metacarpal and trapezium.
  • the passage is optionally distally positioned from a one-way inflation valve included inside an inflation port substantially limiting possible damage to the device due to the insertion pressure of an expansion fluid.
  • An inflation cannula and/or needle may be attached to inflation port and inflation valve for introducing the expansion fluid into the device.
  • the implant is inserted in a deflated mode and is positioned so that thumb metacarpal abuts distal side of the device when expanded and trapezium abuts proximal side. Both distal side and proximal side include a smooth surface for allowing relative movement of thumb metacarpal and trapezium with respect to the device.
  • U.S. Patent Application Publication No. US20130331946A1 disclosing an expandable implantable device sized for occupying space in a cavity formed between small bones in a human hand or foot.
  • Comprising a first smooth surface on which a first small bone may slide. May include an opening extending through the device for promoting fibrotic development through the opening from a direction from both thumb metacarpal and trapezium.
  • An inflation cannula and/or needle may be attached to inflation port and inflation valve for introducing expansion fluid into the device.
  • An implant is inserted in a deflated mode and positioned so that a thumb metacarpal abuts distal side of the device when expanded, and trapezium abuts a proximal side thereof. At least one of distal side and proximal side include a smooth surface for allowing relative movement of thumb metacarpal or/and trapezium with respect to the device.
  • U.S. Patent No. US11033398B2 disclosing a shoulder implant for simulating a naturally occurring bursa proximal to or in lieu of a subacromial bursa, the shoulder implant comprising: an expandable member expandable to a size and/or a shape sufficient to fill a space beneath an acromion and/or a coracoid process of the shoulder, the space defines a filled volume less than a maximal volume occupied by the expandable member if fully expanded; and an amount of filler for filling the expandable member to the filled volume, such that, when implanted, the expandable member is configured to cushion and facilitate motion between a tendon and/or ligament of a rotator cuff, and a bone part in the shoulder.
  • WO2012017438A1 disclosing an apparatus and method for a shoulder implant, for example, for the glenohumeral joint.
  • the implant is expandable and deflatable during implantation.
  • the implant is sized for the gelnoid fossa.
  • the selection and/or implantation of the implant include adapting the implant by size and function to a particular patient's need.
  • U.S. Patent No. US10492916B2 disclosing a shoulder implant for reestablishing a coracoacromial arch in a subject, the shoulder implant comprising: a dorsal surface substantially shaped as a coracoacromial arch of a shoulder, the dorsal surface for engaging at least a posterior portion of the acromion of the subject when implanted in the subject; and an inferior surface substantially shaped as an acromiohumeral arch of a shoulder, the dorsal surface being opposite the inferior surface.
  • the implant may have a spacer having a convex shape to simulate the anatomic contour of a acromiohumeral arch and the spacer coupled to a baseplate.
  • the baseplate and the spacer have a convex surface that may extend the length of the inferior surface of the acromion and anteriorly to the coracoid process.
  • U.S. Patent No. US10959761B2 disclosing a prosthesis including a subacromial spacer having a surface contoured to maintain an acromion in chosen distance to a humeral head upon rotation and fixation means to fixate the subacromial spacer to a humeral medullary cavity and/or an intramedullary fixator implanted or configured for implantation in the humeral medullary cavity.
  • a surgical kit includes the prosthesis and a proximal humeral nail. The fixating means are connectable into a proximal opening of the proximal humeral nail.
  • a method may include: creating a percutaneous passage from an outer-body space to a portion of a humeral head; removing bony tissue to facilitate direct communication between the outer-body space and a humeral medullary cavity enclosed in the humeral head; providing a prosthesis including a subacromial spacer having a surface; and/or fixating the subacromial spacer to the humeral medullary cavity and/or an intramedullary fixator implanted or configured for implantation in the humeral medullary cavity.
  • U.S. Patent No. US9872773B2 disclosing orthopedic implants and systems.
  • the document discloses methods of implant design, manufacture, modeling and implantation as well as to surgical tools and kits used therewith.
  • the implants are designed by analyzing the articular surface to be corrected and creating a device with an anatomic or near anatomic fit; or selecting a pre-designed implant having characteristics that give the implant the best fit to the existing defect.
  • U.S. Patent No. US6712854B2 disclosing an acromial-humeral prosthesis for use in performing acromial-humeral arthoplasty.
  • the prosthesis is useful for cases where massive, irreparable tears to the rotator cuff have occurred.
  • the principle function of the prosthesis is to prevent superior migration of the humeral head.
  • An acromial tray is inserted using a specialized insertion tool. The acromial tray is held in place against a prepared inferior surface of the acromion by a pair of screws.
  • a concave, disc-like polymeric component is affixed to the bottom of the acromial tray by sliding the component onto one or more matching rails on the inferior surface of the acromial tray This component is relieved to accept the long head of the biceps tendon anteriorly and the greater trochanter laterally.
  • the inventive prosthesis helps prevent non-anatomical articulations of the humerus and other inappropriate glenohumeral kinematics.
  • Example 1 A shoulder spacer, comprising: a. an elongated planar body extending along a longitudinal axis between a proximal end and a distal end; b. at least two protrusions, each protrusion extending in a width direction perpendicular to said longitudinal axis, said at least two protrusions positioned between said proximal end and said distal end.
  • Example 2. The shoulder spacer according to example 1, wherein said at least two protrusions are positioned in two different sides in relation to each to each other on said body.
  • Example 3 The shoulder spacer according to example 1 or example 2, wherein a first part of said body extends proximally beyond said protrusions towards said proximal end and a second part of said body extends distally beyond said protrusions towards said distal end.
  • Example 4 The shoulder spacer according to any one of examples 1-3, wherein said first part is smaller than said second part.
  • Example 5 The shoulder spacer according to any one of examples 1-4, wherein said body comprises a cross shape.
  • Example 6 The shoulder spacer according to any one of examples 1-5, wherein said body is solid with a topological genus zero shape.
  • Example 7 The shoulder spacer according to any one of examples 1-6, wherein said elongated planar body comprises an upper surface and a lower surface.
  • Example 8 The shoulder spacer according to any one of examples 1-7, wherein said body comprises a plurality of orifices extending from said upper surface to said lower surface.
  • Example 9 The shoulder spacer according to any one of examples 1-8, wherein said body comprises a plurality of upper orifices partially extending from said upper surface towards said lower surface and a plurality of lower orifices partially extending from said lower surface towards said upper surface.
  • Example 10 The shoulder spacer according to any one of examples 1-9, wherein locations of said upper orifices are intercalated with locations of said lower orifices.
  • Example 11 The shoulder spacer according to any one of examples 1-10, wherein said body is not inflatable.
  • Example 12 The shoulder spacer according to any one of examples 1-11, wherein said body is pliable.
  • Example 13 The shoulder spacer according to any one of examples 1-12, wherein said body comprises a width from 1cm to 12cm.
  • Example 14 The shoulder spacer according to any one of examples 1-13, wherein said body comprises a thickness from 6mm to 16mm.
  • Example 15 The shoulder spacer according to any one of examples 1-14, wherein said body comprises a length up to 12cm.
  • Example 16 The shoulder spacer according to any one of examples 1-15, wherein body is made of a single uniform material.
  • Example 17 The shoulder spacer according to any one of examples 1-16, wherein body is made of two or more materials.
  • Example 18 The shoulder spacer according to any one of examples 1-17, wherein at least one of said two or more materials is a coating material.
  • Example 19 The shoulder spacer according to any one of examples 1-18, wherein surfaces of said body are smooth.
  • Example 20 The shoulder spacer according to any one of examples 1-19, wherein edges of said body are rounded.
  • Example 21 The shoulder spacer according to any one of examples 1-20, wherein said device is configured to float within the body after implantation.
  • Example 22 The shoulder spacer according to any one of examples 1-21, wherein said body is curved so said protrusions face each other.
  • Example 23 The shoulder spacer according to any one of examples 1-22, wherein said protrusions comprise a length of from about 1cm to about 6cm measured from lateral side of the body.
  • Example 24 The shoulder spacer according to any one of examples 1-23, wherein said shoulder spacer comprises an undeployed configuration and a deployed configuration.
  • Example 25 The shoulder spacer according to any one of examples 1-24, wherein in said deployed configuration said body comprises a size and shape configured to occupy a predetermined space and location within a shoulder and between at least two bones.
  • Example 26 The shoulder spacer according to any one of examples 1-25, wherein said proximal end of said body is configured to be positioned on a Glenoid rim, adjacent to a medial retracted stump of a tom cuff.
  • Example 27 The shoulder spacer according to any one of examples 1-26, wherein said distal end of said body is configured to be positioned adjacent to a lateral remnants of a cuff attached to a humeral head, deltoid internal layers.
  • Example 28 The shoulder spacer according to any one of examples 1-27, wherein one protrusion from said at least two protrusions is configured to be positioned in a pocket of an anterior shoulder joint capsule and subscapularis.
  • Example 29 The shoulder spacer according to any one of examples 1-28, wherein one protrusion from said at least two protrusions is configured to be positioned in a pocket of a posterior shoulder joint capsule and teres minor.
  • Example 30 The shoulder spacer according to any one of examples 1-29, wherein said upper surface is configured to face an Acromion and deltoid attachments.
  • Example 31 The shoulder spacer according to any one of examples 1-30, wherein said lower surface is configured to face a humeral head.
  • Example 32 The shoulder spacer according to any one of examples 1-31, wherein said body comprises a plurality of layers.
  • Example 33 The shoulder spacer according to any one of examples 1-32, wherein each of said plurality of layers is configured to degrade.
  • Example 34 The shoulder spacer according to any one of examples 1-33, wherein said degrade is according to a predetermined time period dictated by a material of each of said plurality of layers.
  • Example 35 The shoulder spacer according to any one of examples 1-34, wherein said body is made of an absorbent material; and wherein passage from said undeployed configuration to said deployed configuration is characterized by said body absorbing liquids.
  • Example 36 The shoulder spacer according to any one of examples 1-35, wherein said body is a hollow body; and wherein said hollow body comprises an opening configured to allow insertion of liquids and/or air within said body so as to perform a passage from said undeployed configuration to said deployed configuration.
  • Example 37 The shoulder spacer according to any one of examples 1-36, wherein said body is a hollow body; and wherein said hollow body comprises an opening configured to allow extracting air from within the body so to perform a passage from said deployed configuration to said undeployed configuration.
  • Example 38 The shoulder spacer according to any one of examples 1-37, wherein said body comprises an external envelope, a plurality of internal reinforcement structures and a plurality of macro-pores positioned between said plurality of internal reinforcement structures.
  • Example 39 The shoulder spacer according to any one of examples 1-38, wherein said body is made of a material comprising micro-pores.
  • Example 40 The shoulder spacer according to any one of examples 1-39, wherein said plurality of internal reinforcement structures are positioned so as to provide structural reinforcement to locations on said external envelope where higher levels of pressure are expected.
  • Example 42 The method according to example 41, wherein said predetermined location of said proximal end of said body is on a Glenoid rim, adjacent to a medial retracted stump of a torn cuff.
  • Example 43 The method according to example 41 or example 42, wherein said predetermined location of said distal end of said body is adjacent to a lateral remnants of a cuff attached to a humeral head, deltoid internal layers.
  • Example 44 The method according to any one of examples 41-43, wherein said predetermined location of one protrusion of said at least two protrusions is in a pocket of an anterior shoulder joint capsule and subscapularis.
  • Example 45 The method according to any one of examples 41-44, wherein said predetermined location of one protrusion of said at least two protrusions is in a pocket of a posterior shoulder joint capsule and teres minor.
  • Example 50 The method according to any one of examples 41-49, further comprising bringing said shoulder spacer to an undeployed configuration by extracting air from within said body.
  • Figure 1 is a schematic representation of a movement of the humeral head towards the acromion bone
  • Figure 3 is a schematic representation of an exemplary shoulder spacer, according to some embodiments of the invention.
  • Figure 4 is a schematic representation of an exemplary positioning of an exemplary shoulder spacer within the shoulder, according to some embodiments of the invention.
  • Figure 5 is a schematic representation of exemplary sizes of an exemplary shoulder spacer, according to some embodiments of the invention.
  • Figure 7 is a schematic representation of the use of a double shoulder spacer, according to some embodiments of the invention.
  • Figures 8a-d are images of exemplary reinforced shell shoulder spacers, according to some embodiments of the invention.
  • Figures 8e-g are schematic representations of exemplary internal organization of exemplary reinforced shell shoulder spacers, according to some embodiments of the invention.
  • Figures 8h-k are schematic representations of two distinct exemplary embodiments of the internal reinforcement structures, according to some embodiments of the invention.
  • Figures 9a-c are schematic representations of an exemplary reinforced shell with hollowed external structure, according to some embodiments of the invention.
  • Figure 11 is a schematic representation of an exemplary fillable shoulder spacer, according to some embodiments of the invention.
  • an implantable device configured to be positioned in the shoulder for providing a necessary space and support between the bones.
  • the device comprises at least two states, an undeployed state, where the device comprises a geometry that permits the easy manipulation and storage outside the body of the patient, for example within a delivery device; and a deployed state, where the device comprises a geometry designed to occupy a predetermined space in predetermined locations within the body, for example the shoulder, and between at least two bones.
  • the geometry in the undeployed state allows performing the implantation procedure arthroscopically with or without the insertion of the device into a dedicated delivery system.
  • the device is designed so, in the deployed state, one or more parts of the device occupy specific spaces within the body, for example within the shoulder area, in order to naturally anchor or limit the movement of the device within the space and potentially avoid unwanted movements of the device therein.
  • the device in the deployed state the device comprises a predetermined curvature, optionally independently of the geometry or form of the device.
  • the device comprises one or more protrusions configured to occupy specific areas in the body.
  • the device comprises a predetermined curvature, while in some embodiments the device is flat and is allowed to passively achieve a curvature.
  • the device in the undeployed state comprises a first size, and in the deployed state the device comprises a second size.
  • the second size is from about 50% to about 500% bigger than the first size.
  • the device is made of biodegradable materials. In some embodiments, the device is configured to degrade according to a predetermined degradation rate. In some embodiments, the device is configured to not degrade and is configured to stay implanted in the body for long periods of time or indefinitely.
  • An aspect of some embodiments of the invention relates to a shoulder spacer, optionally a biodegradable shoulder spacer, designed to address the challenges faced by patients with massive, rotator cuff tears (RCTs).
  • RCTs massive, rotator cuff tears
  • a potential advantage of the device is that it potentially provides a minimally invasive treatment for managing RCTs, offering pain relief, promoting appropriate shoulder mechanics, and enhancing the overall well-being of patients, allowing the deltoid muscle to adapt gradually for sufficient time after massive RCT.
  • this spacer is poised to function without requiring sutures or fixation.
  • the device comprises a dedicated shape which matches or at least partially matches the intended space to which the device will be implanted.
  • the device is configured to interact with relevant soft and bony structures.
  • the device is configured to seamlessly fit into the space, potentially ensuring optimal separation, for example, between the acromion bone and the humeral head during a full range of motion (ROM).
  • the articulating surfaces of the device align with the contours of the humeral head and the acromion to promote proper contact and potentially minimize stress and specifically, remain stable during daily activity, without the need for fixation.
  • An aspect of some embodiments of the invention relates to a shoulder spacer made of a material comprising micro-pores, the shoulder spacer comprising an external envelope, a plurality of internal reinforcing structures and macro-pores.
  • the number, position and thickness of the internal reinforcing structures are set according to expected sizes and locations of pressure on the device.
  • an aspect of some embodiments of the invention relates to a shoulder spacer configured to occupy an anatomical area of the subacromial space, between the Glenoid rim, adjacent to the medial retracted stump of the torn cuff and adjacent to the lateral remnants of the cuff attached to the humeral head, deltoid internal layers, within a shoulder and between at least two bones.
  • the spacer comprises an elongated planar body extending along a longitudinal axis between a proximal end and a distal end, the body having a width and a thickness.
  • the spacer comprises at least two protrusions, each protrusion extending laterally and radially from said body a length of from about 1cm to about 6cm, each protrusion being flexible and comprising a round end.
  • the body is curved so said at least two protrusions face each other.
  • the shoulder spacer comprises a cross shape.
  • the protrusions extend in a width direction perpendicular to said longitudinal axis.
  • the at least two protrusions are positioned between the proximal end and the distal end.
  • the at least two protrusions are positioned in two different sides in relation to each other on said body.
  • a first part of the body extends proximally beyond the protrusions towards the proximal end and a second part of the body extends distally beyond the protrusions towards the distal end. In some embodiments, the first part is smaller that said second part.
  • the protrusions comprise a length of from about 1cm to about 8cm measured from lateral side of the body.
  • the body is solid with a topological genus zero shape (no holes).
  • the body is non inflatable.
  • the body is pliable.
  • the width of the device is from about 1cm to about 12cm and the thickness being from about 6mm to about 16mm.
  • the body comprises a length up to 10cm. In some embodiments, the body is made of a single uniform material. In some embodiments, surfaces of the body are smooth and edges of the device are rounded. In some embodiments, the device is configured to float within the body after implantation.
  • the shoulder spacer is made of a material and/or is coated with a material that avoids accumulation of tissue on the spacer shoulder, for example, fibrotic tissue.
  • a potential advantage of doing so is that allows the spacer shoulder to stay “floating” in the area of implantation, which, when required, allows the dynamic function of the spacer shoulder.
  • the shoulder spacer is made of a material and/or is coated with a material that encourages accumulation, or partial accumulation, of tissue on the spacer shoulder, for example, fibrotic tissue.
  • a potential advantage of doing so is that it increases the natural anchoring of the device in the site of implantation.
  • orientations of the exemplary shoulder spacer will be provided in relation to anatomical references, for example, for a shoulder spacer configured to be placed in a right shoulder, when referring to “anterior” it refers to a direction towards the chest of the patient, while referring to “posterior” it refers to a direction towards the back of the patient, while referring to “lateral” it refers to a direction towards the outside of the body of the patient, while referring to “medial” it refers to a direction towards the inside of the body of the patient, following the directional references as schematically shown in Figure lb. It should be understood that the same applies to an exemplary shoulder spacer configured to be placed in a left shoulder.
  • the proximal end of the device refers to the end located in a proximal direction in relation to the patient, also referred to the medial direction, while the distal end refers to the end located far from the patient (in a distal direction), also referred to lateral direction.
  • an exemplary shoulder spacer 300 comprises a body 302 having a lateral end/distal end 304 and a medial end/proximal end 306.
  • the body 302 comprises a posterior side 312 and an anterior side 314.
  • the exemplary shoulder spacer 300 comprises one or more protrusions, for example, a protruding area 308 extending from the posterior side 312 to a posterior direction (referred hereinafter as “posterior wing”) and a protruding area 310 extending from the anterior side 314 to an anterior direction (referred hereinafter as “anterior wing”).
  • the area of the posterior wing 308 and/or the anterior wing 310 are schematically marked by the dotted lines 316/318.
  • the posterior wing 308 and/or the anterior wing 310 do not protrude in the cranial/superior direction.
  • the protrusions extend in a width direction (arrow 320) in relation to a longitudinal axis 322 of the device.
  • the protrusions can be located opposite to one another and aligned to each other or can be positioned opposite to one another but misaligned to each other (see below).
  • each protrusion may extend at any angle in relation to the longitudinal axis of the device, for example, the arrow 320 shows that the protrusions extend at an angle of 90 degrees in relation to the longitudinal axis.
  • the protrusions can extend at any angle ⁇ 90 degrees in relation to the longitudinal axis of the device.
  • the shoulder spacer comprises an elongated planar body extending along a longitudinal axis between a proximal end and a distal end; and at least two protrusions, each protrusion extending in a width direction perpendicular to said longitudinal axis, said at least two protrusions positioned between said proximal end and said distal end.
  • the at least two protrusions are positioned in two different sides in relation to each to each other on the body.
  • a first part of the body extends proximally beyond the protrusions towards the proximal end and a second part of the body extends distally beyond the protrusions towards the distal end.
  • the first part is smaller than the second part.
  • the body comprises a cross shape. In some embodiments, the body comprises a misaligned cross shape.
  • the body is solid with a topological genus zero shape, meaning it has no orifices.
  • the body comprises natural occurring indentations or cavities generated by the materials used in the device.
  • the device comprises orifices as explained below.
  • the body is not inflatable or at least it is not meant to be inflated or it is not required to be inflated in order to be properly deployed in the shoulder.
  • the shoulder spacer comprises a smooth surface. In some embodiments, edges of the body of the shoulder spacer are rounded.
  • device is configured to float within the body after implantation.
  • the body is curved so the protrusions face each other.
  • Figure 3 shows an upper view of an exemplary device 300, showing the upper surface 324.
  • a dashed arrow schematically points towards the lower surface 326 that cannot be seen in Figure 3.
  • the exemplary shoulder spacer 300 comprises a size and shape configured to occupy an anatomical area of the subacromial space, as schematically shown in Figure 4.
  • a potential advantage of designing a form that fits the anatomical area of the subacromial space is that it potentially avoids unwanted movement of the exemplary shoulder spacer 300 within the areas after being positioned.
  • the medial region/proximal end 306 of the device is configured to be positioned on the Glenoid rim, adjacent to the medial retracted stump of the torn cuff.
  • the lateral region/distal end 304 of the device is configured to be positioned adjacent to the lateral remnants of the cuff attached to the humeral head, deltoid internal layers.
  • the anterior "wing" 310 is configured to be positioned in the pocket of the anterior shoulder joint capsule and subscapularis.
  • the posterior wing 308 is configured to be positioned in the pocket of the posterior shoulder joint capsule and teres minor.
  • the superior surface/upper surface 324 of the device is configured to face the Acromion and deltoid attachments.
  • the inferior surface/lower surface 326 of the device is configured to face the humeral head.
  • the shoulder spacer is configured to match the specific anatomy of the patient, for example, the anterior and posterior wings are fitting to the humeral head curvature / radius of curvature post implantation, in the deployed state.
  • the anatomy of the device is used to create a fixed side with the acromion (superior/upper surface) while the humeral head is sliding against the inferior/lower surface during range-of-motion.
  • parts of the protrusions are positioned on the humeral head itself, for example, parts of the areas of the protrusions that face the lateral end/distal end 304 of the device, which are in contact with the humeral head, fit the curvature of the humeral head, while parts of the areas of the protrusions that face the medial end/proximal end 306 of the device, are held, for example, at their respective anatomical pockets, as described elsewhere herein.
  • exemplary sizes of the exemplary shoulder spacer 300 are as follows:
  • a body length - arrow 502 defined as a distance between the most distal end of the lateral end 304 to the most distal end of the medial end 306, of from about 5 centimeter (cm) to about 7cm, optionally a body length of from about 4cm to about 8cm, optionally a body length of from about 3cm to about 12cm, and any value length in between. For example a length of 6cm, 6.5cm, 7.5cm.
  • a body width - arrow 504 defined as a distance between the posterior side 312 and the anterior side 314 where no protruding areas are located, of from about 3cm to about 5cm, optionally a body width of from about 2cm to about 6cm, optionally a body width of from about 2cm to about 8cm, and any value width in between. For example a width of 4cm, 4.5cm, 6.5cm.
  • a protrusion (wing) length - arrow 506 defined as a distance between the locations where the protrusions commence to extend from the posterior side 312 or anterior side 314, of from about 2cm to about 4cm, optionally a wing length of from about 3cm to about 5cm, optionally a wing length of from about 1cm to about 6cm, and any value wing length in between. For example a wing length of 3cm, 3.5cm, 4.5cm.
  • a protrusion (wing) width - arrow 508 defined as a distance between the most distal anterior/posterior location of the wing to the dotted lines 316/318, of from about 2cm to about 4cm, optionally a wing width of from about 3 cm to about 5cm, optionally a wing width of from about 1cm to about 8cm, and any value wing length in between. For example a wing width of 3cm, 3.5cm, 4.5cm.
  • a space between protrusions (wings) - arrow 510 defined a distance between the two dotted lines 316/318, of from about 1cm to about 3cm, optionally a space of from about 0.5cm to about 4cm, optionally a space of from about 0.3cm to about 5cm, and any value wing length in between. For example a space of 2cm, 2.5cm, 3.5cm.
  • the width and/or thickness of the lateral end/distal end 304 of the device is larger than the width and/or thickness of the medial end/proximal end 306 of the device.
  • the width and/or thickness of the lateral end/distal end 304 of the device is shorter than the width and/or thickness of the medial end/proximal end 306 of the device.
  • the width and/or thickness of the lateral end/distal end 304 of the device is the same as the width and/or thickness of the medial end/proximal end 306 of the device.
  • the width and/or thickness of the posterior wing 308 of the device is larger than the width and/or thickness of the anterior wing 310 of the device.
  • the width and/or thickness of the posterior wing 308 of the device is shorter than the width and/or thickness of the anterior wing 310 of the device.
  • the width and/or thickness of the posterior wing 308 of the device is the same as the width and/or thickness of the anterior wing 310 of the device.
  • Figures 6a-6j showing schematic representations of exemplary geometries and curvatures of exemplary shoulder spacers, according to some embodiments of the invention. Same parts having referral numbers of Figure 3 are used in Figures 6a-6j.
  • Figure 6a shows an exemplary shoulder spacer comprising a flat configuration.
  • the device is prepared a priori having a flat configuration. This means that under no external forces, the device naturally achieves a flat configuration.
  • Figure 6b shows an exemplary shoulder spacer comprising a convex configuration.
  • the device is prepared a priori having a “severe” convex configuration, for example the device comprises a radius of curvature of about 25mm, optionally from about 15mm to about 20mm, optionally from about 10mm to about 25mm, optionally from about 8mm to about 35mm. This means that under no external forces, the device naturally achieves a severe convex configuration.
  • Figure 6c shows an exemplary shoulder spacer comprising a convex configuration.
  • the device is prepared a priori having a “mild” convex configuration, for example the device comprises a radius of curvature of about 50mm, optionally from about 35mm to about 45mm, optionally from about 30mm to about 55mm, optionally from about 25mm to about 70mm. This means that under no external forces, the device naturally achieves a mild convex configuration.
  • Figure 6d shows an exemplary shoulder spacer comprising a flat configuration.
  • the device is prepared a priori having a flat configuration and a shorter body with shorter protrusions. This means that under no external forces, the device naturally achieves a flat configuration.
  • Figures 6e and 6f are similar to Figures 6b and 6c, but with a shoulder spacer as shown in Figure 6d.
  • Figure 6g shows an exemplary shoulder spacer comprising a convex configuration.
  • the device is prepared a priori having a convex configuration and wider protrusions (comparing to figures 6a-c). This means that under no external forces, the device naturally achieves a flat configuration.
  • Figure 6h shows an exemplary shoulder spacer comprising a convex configuration.
  • the device is prepared a priori having a convex configuration and two distinct protrusions opposite to each other and being misaligned in relation to each other.
  • Figure 6i shows an exemplary shoulder spacer where a protrusion 310 is as disclosed above, while the other protrusion 308 is configured to enter the Supraspinatus Fossa.
  • Figure 6j shows an exemplary shoulder spacer having one wide protrusions 308 and one narrow protrusion 310. Exemplary use of more than one shoulder spacer
  • FIG 7 showing a schematic representation of the use of a double shoulder spacer, according to some embodiments of the invention.
  • more than one device is used in order to fill-in the desired space within the shoulder.
  • two shoulder spacers 702/704 are shown, one on top of the other.
  • a first device is rolled and installed, for example, arthroscopically via a ⁇ lcm diameter portal.
  • a second device will be located on top or under the first one without the need of any connection between them.
  • each device is limited in movement within the subacromial space but comprises the flexibility to move a relative motion against the other device/s during daily activity.
  • the length and width of the device are similar or the same as the dimension ranges as described herein elsewhere and the thickness can be with a small minimal value range from 1mm to 10mm.
  • each device will have a thickness of 4-6mm and the decision of using 1, 2 or 3 devices will be made by the surgeon, based on the target space size of the specific patient.
  • the exemplary shoulder spacer shown for example in Figure 3 or the exemplary thinner version of the shoulder spacer shown in Figure 7, can be used in addition to an RTC repair (and not only instead of an RTC repair).
  • a potential advantage of using the exemplary shoulder spacers is that it can potentially provide protection to the repair while it heals.
  • the device is configured to resist the pressure developed under physiological loads.
  • the shoulder spacer is made of pliable materials.
  • the shoulder spacer is made of a single uniform material.
  • the shoulder spacer is made of two or more materials.
  • one of the materials is used for coating the shoulder spacer. In some embodiments, this is achieved by utilizing one or more of the following materials: any biocompatible material including, but not limited to, polymers, such as, biodegradable polyesters made from hydroxyl alkanoic acids, polyorthoesters, polyphosphaZenes, polyphosphate esters, poly anhydrides and copolymers and blends thereof.
  • Homo and copolyesters made from lactic acid, glycolic acid, and caprolactone are those that are in clinical use and have already shown to be safe with predictable biodegradability, i.e. PGS - Poly(glycerol sebacate), PGSU - Poly(glycerol sebacate) urethane, PCL, PGA, PHB, plastarch material, PEEK, zein, PDO, PLA, PLGA, polycaprolactone, polydiaxone, polylactide, poly(lactide-glycolide), poly(lactide-caprolactone) and polycaprolactone or a Shape Memory Polymer (SMP) made for example from multi block copolymers of lactide and caprolactone which can assume an elongated state when heated and a coiled state when cooled to body temperature or any combination thereof.
  • SMP Shape Memory Polymer
  • the properties of the polymer compositions can be tailored to fit any requirements by either blending various polymers or mixing the polymer with hydrophobic or hydrophilic additives that alter the polymer properties.
  • additives can be plasticizers that increase the flexibility of the device, hydrophilic components such as poly(ethylene glycol) and minerals that increase hydrophilicity and serve as pore making agents.
  • Hydrophobic components can be triglycerides, fatty acids and esters and other biodegradable polymers.
  • the polymer structure and molecular weight play a significant role in designing the desired properties of the polymer composition.
  • the device can be manufactured from natural, biocompatible and/or biodegradable materials such as collagen, agarose, poly(ethylene-glycol)(PEG) and/or methyl cellulose.
  • the device is manufactured from at least one non-biodegradable material such as polyethylene (PE), polyurethane (PU), silicon (Si), Dyneema® and/or Kevlar®.
  • the shoulder spacer is made of a material and/or is coated with a material that avoids accumulation of tissue on the spacer shoulder, for example, fibrotic tissue.
  • a potential advantage of doing so is that allows the spacer shoulder to stay “floating” in the area of implantation, which, when required, allows the dynamic function of the spacer shoulder.
  • the shoulder spacer is made of a material and/or is coated with a material that encourages accumulation, or partial accumulation, of tissue on the spacer shoulder, for example, fibrotic tissue.
  • a potential advantage of doing so is that it increases the natural anchoring of the device in the site of implantation.
  • the form/geometry of the device allows the device to not generate focal peak pressure under the Acromion and distribute pressure under the Acromion similarly to native state.
  • the area under pressure will allow up to 50% thickness decrease, for example a decrease of 5-6 mm, under weight-bearing.
  • an exemplary shoulder spacer 300 is designed, by means of its size and/or shape and/or composition, to provide one or more of the following characteristics:
  • An exemplary shoulder spacer 300 is configured to resist a pick force of ⁇ 50 Newton
  • An exemplary shoulder spacer 300 is configured to be compressed to 50% of its thickness under a maximal pressure of 1 MPa;
  • An exemplary shoulder spacer 300 is configured to have an Elastic Modulus of between about 1 MPa and about 20 MPa;
  • An exemplary shoulder spacer 300 is configured to distribute pressure between the contact surfaces of the shoulder spacer and the bones so the averaged pressure will be from about lOOkPa to about 200kPa, where a peak pressure will be from about 600kPa to about 1500kPa.
  • an exemplary shoulder spacer 300 is made of materials that absorb liquids that cause an increment in the size of the shoulder spacer 300.
  • the shoulder spacer is configured to increase its size following a range of ratio of between about 1:1.5 and about 1:5; optionally between about 1 : 1.1 to about 1 : 10. Or in other words, the shoulder spacer is configured to increase its size from about 50% to about 500% when exposed to liquids and/or to a liquid environment.
  • a potential advantage of using a device that increases its size after implantation is that is potentially allows to generate a small device that it is easy to implant arthroscopically, while then achieving a required size that fulfills the mechanical requirements.
  • the device irreversibly increases its size.
  • an exemplary shoulder spacer can both irreversibly increase its size and degrade over time (see below explanations about degradation).
  • exemplary materials used for the absorption qualities are hydrogels, for example: Poly(Acrylic Acid) having an average Viscosity average molecular weight (M v ) of 4000000, 3000000, 1250000, 450000, or any combination thereof; or for example Collagen-based absorbable materials; or for example any other suitable absorbable material.
  • the device is inserted, in an undeployed state, through an arthroscopic portal of up to 12 mm diameter or by using a mini-open procedure through a 3-4 cm incision.
  • the exemplary shoulder spacer 300 is rolled into a cylindrical shape using, for example, a vacuum packaging or any other similar technique, which allows the insertion of the device using a standard arthroscopic delivery system.
  • the device when inserted using mini-open procedure, the device will be inserted through the incision manually by the surgeon.
  • the device is released to a deployed state, naturally occupying the area in the shoulder.
  • an exemplary shoulder spacer 300 is delivered without the need of a dedicated delivery system.
  • an exemplary shoulder spacer 300 is made from sponge and/or sponge-like materials (referred hereinafter as sponge-based shoulder spacer).
  • the exemplary sponge-based shoulder spacer is manufactured having the desired dimensions when in a deployed state.
  • the exemplary sponge-based shoulder spacer is configured to be compressed in order to bring the device to an undeployed state.
  • the undeployed state comprises a shape of a cylinder.
  • an exemplary sponge-base space shoulder comprises a diameter of from about 10mm to about 12mm, optionally from about 8mm to about 14mm, optionally from about 6mm to about 16mm.
  • the exemplary sponge-based shoulder spacer in a deployed state, preserves a thickness of about 5mm under peak force developed in the shoulder during range-of-motion in weight bearing.
  • the exemplary sponge-based shoulder is manufactured using 3D printing technology.
  • Figure 8a shows an frontal view of an exemplary reinforced shell shoulder spacer
  • Figure 8b shows an upper view of a reinforced shell shoulder spacer
  • Figure 8c shows a cross section of a reinforced shell shoulder spacer (cross section line schematically depicted by the line 804 in Figure 8b)
  • Figure 8d is a close view of the area marked in Figure 8c.
  • an exemplary reinforced shell shoulder spacer comprises an external envelope 802, a plurality of internal reinforcing structures, macro-pores and/or micro-pores.
  • a reinforced shell shoulder spacer is generated using a “spongy” raw material as the filler material of the Internal-Reinforcement-Structures, resulting with a spongy structure (Macro-pores) made of a spongy material with smaller pores (Micro-pores).
  • the reinforced shell shoulder spacer comprises the external envelope 802.
  • the external envelope 802 there are a plurality of internal reinforcement structures 806 extending within the external envelope 802.
  • macro-pores are generated 808 in the space absent of the internal reinforcement structures 806.
  • the whole reinforced shell shoulder spacer is made of a material that comprises micro-pores 810.
  • the internal reinforcement structures 806 are generated having a dedicated geometry.
  • the internal reinforcement structures 806 extend at an angle “a”, while in Figure 8f the internal reinforcement structures 806 extend at an angle of 90 degrees.
  • the internal reinforcement structures 806 have a “V” shape structure that extend at an angle “a” at the bottom part, change direction at mid space at an angle “9” reaching the top part at an angle “p”.
  • Figures 8h-i and 8j-k show two distinct exemplary embodiments of the internal reinforcement structures 806, according to some embodiments of the invention.
  • Figures 8h-i show tubular internal reinforcement structures 806, while Figures 8j-k show flat internal reinforcement structures 806.
  • an exemplary reinforced shell shoulder spacer is optionally designed to have more structural internal reinforcing structures in areas where is high pressure is predicted to be applied on the shoulder spacer.
  • the size, number and shape of the internal reinforcement structures, the macro-pores, and the micro-pores are based on the design criteria of the final device.
  • an exemplary reinforced shell is as shown in Figures 8a-k, with the addition of a plurality of orifices 902 traversing the entire length of the body of the device, or at least partially traversing the length of the body of the device.
  • an exemplary method of generating the reinforced shell with hollowed external structure is, for example, taking a device as disclosed in Figures 8a-k and creating holes from the outside-in.
  • a potential advantage of performing the orifices is that it generates a flexible structure that will fulfil the design requirements (load bearing, volume, fatigue etc.,), and also will be easier to roll, for example into a ⁇ 10mm tube, that will allow a surgeon to install the device arthroscopically.
  • the orifices 902 can be generated through cut, drilling etc., or be part of the mold inserts in injection molding or a similar method.
  • the positioning of the orifices 902 is not random and can be as a “through all” orifices from superior to inferior surfaces as depicted in Figure 9b, or “half through” from each surface, as described in Figure 9c.
  • positioning the macro-pores in opposite location with respect with the macro-pores of the other side allows less material affecting the device thickness when rolling it to the undeployed state for arthroscopic installation.
  • the positioning of the superior macro-pores is “negative” to the position of the inferior macro-pores (as shown for example in Figure 9c).
  • an exemplary shoulder spacer is optionally made of a biodegradable material (the device can be made of either biodegradable or non-biodegradable materials).
  • the exemplary shoulder spacer when the exemplary shoulder spacer is made of biodegradable materials, the exemplary shoulder spacer is designed to degrade gradually and/or in a controlled manner.
  • a potential advantage of providing a shoulder spacer that degrades gradually and/or in a controlled manner is that it potentially avoids a sudden loss of support as usually happens with other types of shoulder spacers, for example with balloon shoulder spacers, in which at the moment the balloon malfunctions, the user suddenly loses the support provided by the device potentially causing damage, pain and may prevent optimal rehabilitation of the joint.
  • the exemplary shoulder spacer when the exemplary shoulder spacer is made of biodegradable materials, the exemplary shoulder spacer is designed to function for a period of time of from about 6 months to about 12 months, according to the requirements, while keeping a distance between the Acromion and humeral head of at least 11mm, preferably while keeping a distance of from about 7mm to about 13mm, for example a distance of from about 10mm to about 12mm, optionally form about 11mm to about 15mm, optionally from about 11mm to about 20mm.
  • the shoulder spacer is configured to completely degrade after 12 months, optionally after a period of time of from about 12 months to about 18 months, optionally after a period of time from about 12 months to about 24 months.
  • an exemplary shoulder spacer is made of biodegradable materials and is designed to degrade gradually and/or in a controlled manner.
  • controlling the rate of degradation is performed by providing the exemplary shoulder spacer with a single body having a known degradation rate.
  • controlling the rate of degradation is performed by providing the exemplary shoulder spacer with one or more layers, each layer having a known degradation rate.
  • the degradation rate is influenced and or preconfigured according to one or more of: the type of material, the composition of the material and the thickness of the material.
  • layers may vary in thickness within a range of for example from about 0.1mm to about 2mm each, based on the required degradation timing.
  • a potential advantage of designing a shoulder spacer comprising a layers-based degradation mechanism is that it potentially allows a staged adaptation of the shoulder muscles to volume changes of the shoulder spacer and potentially ensures that the degradation will occur in the direction of the thickness of the shoulder spacer (not in the width direction or the length direction).
  • a principle of degradation of an exemplary shoulder spacer involves a degradation in the height (or thickness) axis alone, keeping the width and length of the device constant during the degradation process.
  • a potential advantage of limiting the degradation to the height axis is that it potentially allow the device to stay anchored in position during the degradation process and potentially avoiding unwanted movement of the device in the shoulder area even at advanced degradation stages.
  • the degradation is designed to occur mainly from one side of the shoulder spacer, as shown for example in Figures lOa-c.
  • Figure 10a shows a cutaway view of a portion of an exemplary shoulder spacer at the beginning of the process.
  • a top layer 1002 is configured to either not degrade at all or to degrade last after a predetermined period of time (for example after 12 months).
  • Lower layers 1004, 1006, 1008 and 1010 will degrade one after another.
  • the lower layer 1004 after a predetermined period of time, the lower layer 1004 will degrade exposing the next layer, layer 1006.
  • the layer 1006 will degrade exposing the next layer, layer 1008.
  • the degradation process continues until all the layers degrade or until reaching the top layer 1002 when configured to not degrade.
  • the degradation is designed to occur from both sides of the shoulder spacer, as shown for example in Figures lOd-f.
  • Figure lOd shows a cutaway view of a portion of an exemplary shoulder spacer at the beginning of the process.
  • the shoulder spacer comprises a top and bottom layer 1012, each followed towards the center of the shoulder spacer by layers 1014, then by layers 1016, and so on until reaching a central layer 1018, which can optionally be degradable or not degradable.
  • the top and bottom layers 1012 degrade first, as shown for example in Figure lOe, exposing layers 1014.
  • the layers 1014 will degrade exposing the next layer, layers 1016.
  • the degradation process continues until all the layers degrade or until reaching the center layer 1018 when configured to not degrade.
  • the degradation rate is set a priori according to the type and/or composition and/or thickness of the layer of the materials used.
  • the degradation of the shoulder spacer comprises a reduction in thickness, rather than isotropic degradation.
  • a potential advantage of this is that the device degrades while keeping the natural anchoring achieved by the geometry of the device.
  • the exemplary shoulder spacer when the exemplary shoulder spacer is made of non-biodegradable materials, the exemplary shoulder spacer is designed to encourage cell proliferation within the shoulder spacer after implantation therefore allowing the generation of a visco-elastic volume within the subacromial space.
  • the exemplary shoulder spacer when the exemplary shoulder spacer is made of non-biodegradable materials, the exemplary shoulder spacer comprises a pore-based scaffold structured as interconnected channels having a diameter of from about 150 micrometer (or micron - pm) to about 250pm, optionally from about 200pm to about 400pm, optionally from about 100pm to about 600pm, for example about 200pm, 220pm, 270pm.
  • the scaffold comprises one or more of growth factors, drugs or similar agents to accelerate cell growth within the structure.
  • an exemplary shoulder spacer 1100 comprises a fillable body (referred hereinafter as fillable shoulder spacer 1100).
  • an exemplary form of the body of the fillable body is as shown for example in Figures 3, 6a-j and 8a-k.
  • an exemplary fillable shoulder spacer 1100 comprises an opening 1102 configured to allow insertion or extraction of materials from and to within the body of the fillable shoulder spacer 1100.
  • the opening can be located at any position on the surface of the fillable shoulder spacer 1100.
  • an exemplary fillable shoulder spacer 1100 comprises an undeployed state and a deployed state. In some embodiments, additionally, an exemplary fillable shoulder spacer 1100 comprises an empty state and a filled state. In some embodiments, an exemplary fillable shoulder spacer 1100 is prepared by bringing it to an empty and undeployed state. In some embodiments, in this state, the exemplary fillable shoulder spacer 1100 packed as previously disclosed, and inserted in to the shoulder. In some embodiments, the exemplary fillable shoulder spacer 1100 is then brought to an empty-deployed state within the shoulder.
  • the exemplary fillable shoulder spacer 1100 is then brought to a filled-deployed state within the shoulder by inserting a material within the body via the opening 1102.
  • the exemplary fillable shoulder spacer 1100 is brought directly from an empty- undeployed state to a filled-deployed state by inserting a material within the body via the opening 1102, without the need to perform a dedicated separate step of deploying the body.
  • an exemplary fillable shoulder spacer 1100 is filled with one or more of: a foam, a PU foam, a sponge-based foam, hydrogel, and any combination thereof.
  • the materials used to fill an exemplary fillable shoulder spacer are configured to allow the passage from an undeployed state to a deployed state due to sponge-based characteristics of the material inserted therein and/or due to exposure of the material to an environment, for example hydrogels.
  • an exemplary method to achieve an undeployed state capable to be installed through arthroscopic portal of ⁇ 10mm diameter is to use the opening 1102 located in one of the device walls (medial, lateral, anterior or posterior) from which a delivery instrument will be connected and apply vacuum pressure that will allow an efficient rolling of the device into an insertion tube.
  • the device after positioning the device inside the desired place in-situ, the device will be released so air and/or fluid from the joint environment could enter the structure again and the desired volume will be achieved.
  • exemplary manufacturing methods of exemplary shoulder spacer 200 can be one or more of: cast molding, dip molding, 3D printing methods, injection molding, core-shell and in-situ solidification.
  • implanting an exemplary shoulder spacer comprises one or more of the following actions:
  • the predetermined positions are: for the medial region 206 of the device: on the Glenoid rim, adjacent to the medial retracted stump of the tom cuff; for the lateral region 304 of the device: adjacent to the lateral remnants of the cuff attached to the humeral head, deltoid internal layers; for the anterior "wing” 310: in the pocket of the anterior shoulder joint capsule and subscapularis; for the posterior "wing” 308: in the pocket of the posterior shoulder joint capsule and teres minor; for the superior surface: facing the Acromion and deltoid attachments; and for the inferior surface: facing the Humeral head.
  • the method further comprises exposing the shoulder spacer to liquids thereby allowing the body of the shoulder spacer to absorb the liquids.
  • the method further comprises inserting liquids within said hollow body through said opening so as to perform the passage from said undeployed configuration to said deployed configuration.
  • a compound or “at least one compound” may include a plurality of compounds, including mixtures thereof.
  • method refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.
  • treating includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.
  • Patient-Specific-The device can be design to be a patient-specific product that will include one or more of the following steps: 1. Pre-operative MR-scan (standard shoulder protocol for RCT)
  • Step I - The injected polymer will be injected to the mold, it can be melted by pressure injection or as viscous fluid without melting. It can be degradable polymer or permanent non-degradable polymer, it can be spongy or dense.
  • Step II After solidification of the injected material, water or other fluid will be entered to the core volume in a way that the core dissolvable structure will be dissolved and washed out.
  • Step III Releasing the injected polymer from the permanent mold.

Landscapes

  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (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)
  • Details Of Garments (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

L'invention concerne un écarteur d'épaule comprenant un corps ayant une configuration non déployée et une configuration déployée ; dans la configuration déployée, le corps a une taille et une forme qui occupent un espace et un emplacement prédéterminés à l'intérieur d'une épaule et entre au moins deux os. Le corps de l'écarteur d'épaule a une région médiane, une région latérale, une aile antérieure, une aile postérieure, une surface supérieure et une surface inférieure.
PCT/IL2024/050665 2023-07-10 2024-07-08 Écarteur d'épaule Pending WO2025012896A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363525736P 2023-07-10 2023-07-10
US63/525,736 2023-07-10

Publications (2)

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WO2025012896A2 true WO2025012896A2 (fr) 2025-01-16
WO2025012896A3 WO2025012896A3 (fr) 2025-02-27

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Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006133711A2 (fr) * 2005-06-14 2006-12-21 Cartificial A/S Dispositif medical s'introduisant dans une articulation
IT1394588B1 (it) * 2009-05-06 2012-07-05 Pinto Spaziatore subacromiale e strumenti per il suo impianto
US20130116794A1 (en) * 2010-08-04 2013-05-09 Shaul Shohat Shoulder implant
US9345577B2 (en) * 2013-03-14 2016-05-24 Microaire Surgical Instruments Llc Balloon implant device
EP3740165B1 (fr) * 2019-02-13 2021-06-16 Joseph A. Abboud Espaceurs d'articulation
US12290443B2 (en) * 2020-05-01 2025-05-06 Ensemble Orthopedics, Inc. Implantable interpositional orthopedic pain management
US20230210652A1 (en) * 2021-12-31 2023-07-06 John Schelter Trilobe Inflatable Implants Methods and Systems

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