Shoulder spacer

Abstract

The invention relates to a shoulder spacer comprising a body having an undeployed configuration and a deployed configuration; where in the deployed configuration the body has a size and shape that occupies a predetermined space and location within a shoulder and between at least two bones. The body of the shoulder spacer has a medial region, a lateral region, an anterior wing, a posterior wing, a superior surface and an inferior surface.

Description

[0001] SHOULDER SPACER

[0002] RELATED APPLICATION / S

[0003] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 525,736, filed on July 10, 2023, the contents of which are incorporated herein by reference in their entirety.

[0004] FIELD AND BACKGROUND OF THE INVENTION

[0005] 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.

[0006] Rotator Cuff Tear (RCT) 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).

[0007] Patients with RCT will lack the centralization mechanism of the rotator cuff tendons when the arm is raised. The Humeral head can move up and an impingement with the Acromion bone occur, as schematically shown in Figure 1. The last lead to pain and eventually to functional limitation and disability of the patient’s range of motion.

[0008] Additional background art includes U.S. Patent No. US8894713B2 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 glenoid fossa. The selection and / or implantation of the implant include adapting the implant by size and function to a particular patient's need.

[0009] U.S. Patent No. US9314944B2 disclosing a tissue displacement / separation device. The device includes a bladder which is expandable between a first tissue and a second tissue of a body. The bladder has an expanded shape which is selected capable of displacing or separating the first tissue from the second tissue in a manner suitable for protecting the first tissue from an effect of a treatment applied to the second tissue.

[0010] 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.

[0011] 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.

[0012] 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.

[0013] 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. International Patent Application No. WO2012017438A1 disclosing an apparatus and method for a shoulder implant, for example, for the glenohumeral joint. Optionally, the implant is expandable and deflatable during implantation. Optionally the implant is sized for the gelnoid fossa. In an exemplary embodiment of the invention, the selection and / or implantation of the implant include adapting the implant by size and function to a particular patient's need.

[0014] 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. In certain embodiments, 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.

[0015] U.S. Patent No. US 11241256B2 disclosing selectively placed implants that are specifically configured and dimensioned to address pathologies of the shoulder joint arising from improper force distribution. By using appropriately sized and positioned implants, displacement of targeted connective and muscle tissues acting on the shoulder is accomplished in order to realign force vectors and / or alter moment arms loading the joint to achieve therapeutic effects without cutting bone and with minimal cutting of the connective tissues.

[0016] 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.

[0017] 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.

[0018] U.S. Patent application No. US20210030553A1 disclosing a glenoid implant including a body and a flange. The body includes a bearing surface and a bone-contacting surface opposite the bearing surface. The flange extends from the bone-contacting surface of the body to a free end. The flange has an inside facing surface that faces a center of the body and an outside facing surface that faces an outer perimeter of the body. The outside facing surface is opposite the inside facing surface and each of the inside and outside facing surfaces extend from the bone-contacting surface to the free end. The outside facing surface at the bone-contacting surface of the body is 8 mm or less from the outer perimeter of the body. The outside facing surface is tapered from the bone-contacting surface toward the free end. The inside facing surface is non-parallel to the outside facing surface.

[0019] 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.

[0020] SUMMARY OF THE INVENTION

[0021] Following is a non-exclusive list including some examples of embodiments of the invention. The invention also includes embodiments which include fewer than all the features in an example and embodiments using features from multiple examples, also if not expressly listed below.

[0022] 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.

[0023] 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.

[0024] Example 4. The shoulder spacer according to any one of examples 1-3, wherein said first part is smaller than said second part.

[0025] Example 5. The shoulder spacer according to any one of examples 1-4, wherein said body comprises a cross shape.

[0026] Example 6. The shoulder spacer according to any one of examples 1-5, wherein said body is solid with a topological genus zero shape.

[0027] 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.

[0028] 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.

[0029] 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.

[0030] 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.

[0031] Example 11. The shoulder spacer according to any one of examples 1-10, wherein said body is not inflatable.

[0032] Example 12. The shoulder spacer according to any one of examples 1-11, wherein said body is pliable.

[0033] Example 13. The shoulder spacer according to any one of examples 1-12, wherein said body comprises a width from 1cm to 12cm.

[0034] Example 14. The shoulder spacer according to any one of examples 1-13, wherein said body comprises a thickness from 6mm to 16mm.

[0035] Example 15. The shoulder spacer according to any one of examples 1-14, wherein said body comprises a length up to 12cm.

[0036] 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.

[0037] 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.

[0038] Example 19. The shoulder spacer according to any one of examples 1-18, wherein surfaces of said body are smooth.

[0039] Example 20. The shoulder spacer according to any one of examples 1-19, wherein edges of said body are rounded.

[0040] 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.

[0041] Example 22. The shoulder spacer according to any one of examples 1-21, wherein said body is curved so said protrusions face each other.

[0042] 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.

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] Example 32. The shoulder spacer according to any one of examples 1-31, wherein said body comprises a plurality of layers.

[0051] Example 33. The shoulder spacer according to any one of examples 1-32, wherein each of said plurality of layers is configured to degrade.

[0052] 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.

[0053] 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.

[0054] 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.

[0055] 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.

[0056] 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.

[0057] Example 39. The shoulder spacer according to any one of examples 1-38, wherein said body is made of a material comprising micro-pores.

[0058] 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.

[0059] Example 41. A method for implanting a shoulder spacer in a human shoulder, the method comprising: a. providing a shoulder spacer according to any one of examples 1-40 in an undeployed configuration; b. placing said shoulder spacer in said shoulder; c. bringing said shoulder spacer from said undeployed configuration to a deployed configuration; wherein said bringing said shoulder spacer to said deployed configuration comprises positioning said proximal end, said distal end, said at least two protrusions, said upper surface and said lower surface, each in a predetermined location within said shoulder.

[0060] 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.

[0061] 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.

[0062] 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.

[0063] 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.

[0064] Example 46. The method according to any one of examples 41-45, wherein said predetermined location of said upper surface is facing an Acromion and deltoid attachments.

[0065] Example 47. The method according to any one of examples 41-46, wherein said predetermined location of said lower surface is facing a humeral head.

[0066] Example 48. The method according to any one of examples 41-47, wherein said bringing said shoulder spacer from said undeployed configuration to a deployed configuration comprises exposing said shoulder spacer to liquids thereby allowing said body of said shoulder spacer to absorb said liquids.

[0067] Example 49. The method according to any one of examples 41-48, wherein said bringing said shoulder spacer from said undeployed configuration to a deployed configuration comprises inserting liquids within at least one cavity in said shoulder spacer.

[0068] 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.

[0069] Example 51. The method according to any one of examples 41-50, wherein said bringing said shoulder spacer to an undeployed configuration comprises rolling said body. Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0070] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0071] Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

[0072] In the drawings:

[0073] Figure 1 is a schematic representation of a movement of the humeral head towards the acromion bone;

[0074] Figures 2a-b are schematic representations of the directional references that will be used during the explanations of exemplary embodiments

[0075] Figure 3 is a schematic representation of an exemplary shoulder spacer, according to some embodiments of the invention;

[0076] 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;

[0077] Figure 5 is a schematic representation of exemplary sizes of an exemplary shoulder spacer, according to some embodiments of the invention;

[0078] Figures 6a-j are schematic representations of exemplary geometries and curvatures of exemplary shoulder spacers, according to some embodiments of the invention;

[0079] Figure 7 is a schematic representation of the use of a double shoulder spacer, according to some embodiments of the invention;

[0080] Figures 8a-d are images of exemplary reinforced shell shoulder spacers, according to some embodiments of the invention;

[0081] 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;

[0082] Figures 9a-c are schematic representations of an exemplary reinforced shell with hollowed external structure, according to some embodiments of the invention;

[0083] Figures lOa-f are schematic representations of an exemplary degradation process of an exemplary shoulder spacer, according to some embodiments of the invention;

[0084] Figure 11 is a schematic representation of an exemplary fillable shoulder spacer, according to some embodiments of the invention; and

[0085] Figure 12 is a flowchart of an exemplary method of implantation of an exemplary shoulder spacer, according to some embodiments of the invention.

[0086] DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

[0087] The present invention, in some embodiments thereof, relates to a shoulder spacer and, more particularly, but not exclusively, to a shoulder spacer configured to preserve a desirable size over time.

[0088] Overview

[0089] An aspect of some embodiments of the invention relates to an implantable device (referred hereinafter just as “the device”) configured to be positioned in the shoulder for providing a necessary space and support between the bones. In some embodiments, 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. In some embodiments, 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. In some embodiments, 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. In some embodiments, in the deployed state the device comprises a predetermined curvature, optionally independently of the geometry or form of the device. In some embodiments, the device comprises one or more protrusions configured to occupy specific areas in the body. In some embodiments, the device comprises a predetermined curvature, while in some embodiments the device is flat and is allowed to passively achieve a curvature. In some embodiments, the device in the undeployed state comprises a first size, and in the deployed state the device comprises a second size. In some embodiments, the second size is from about 50% to about 500% bigger than the first size. In some embodiments, 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.

[0090] 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). 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. By providing structural support between the acromion bone and the humeral head and by reducing pain during daily activity, this spacer is poised to function without requiring sutures or fixation. In some embodiments, the device comprises a dedicated shape which matches or at least partially matches the intended space to which the device will be implanted. In some embodiments, the device is configured to interact with relevant soft and bony structures. In some embodiments, 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). In some embodiments, 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.

[0091] 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. In some embodiments, optionally, the number, position and thickness of the internal reinforcing structures are set according to expected sizes and locations of pressure on the device.

[0092] 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. In some embodiments, 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. In some embodiments, 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. In some embodiments, the body is curved so said at least two protrusions face each other. In some embodiments, the shoulder spacer comprises a cross shape. In some embodiments, the protrusions extend in a width direction perpendicular to said longitudinal axis. In some embodiments, the at least two protrusions are positioned between the proximal end and the distal end. In some embodiments, the at least two protrusions are positioned in two different sides in relation to each other on said body. In some embodiments, 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. In some embodiments, the protrusions comprise a length of from about 1cm to about 8cm measured from lateral side of the body. In some embodiments, the body is solid with a topological genus zero shape (no holes). In some embodiments, the body is non inflatable. In some embodiments, the body is pliable. In some embodiments, the width of the device is from about 1cm to about 12cm and the thickness being from about 6mm to about 16mm. In some embodiments, 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.

[0093] In some embodiments, 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. In some embodiments, 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.

[0094] Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or the examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0095] Referring now to Figure 2a, showing a schematic representation of the directional references that will be used during the explanations of exemplary embodiments. In the following explanations, 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.

[0096] Referring also to Figure 2b, showing a schematic representation of an additional directional reference that will be used during the explanations of exemplary embodiments. In the following explanations, orientations of the exemplary shoulder spacer will be provided in relation to the device itself, for example, an implant comprises a body presenting a proximal end, a distal end, an upper surface, a lower surface (cannot be seen in Figure 2b), a width, a length and a thickness.

[0097] Lastly, a combination between the two reference systems can be used in order to provide a person having skills in the art with the necessary information to understand the invention. For example, 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.

[0098] Referring now to Figure 3, showing a schematic representation of an exemplary shoulder spacer, according to some embodiments of the invention. In all figures, same parts are provided with the same referral numbers.

[0099] The following explanations follow the directional references of Figures 2a-b, and are directed, just for the sake of the explanations, to an exemplary shoulder spacer configured to be positioned in a right shoulder, and the relevant directional references are accordingly used. These are provided just as an example to allow a person having skills in the art to understand the invention and are not meant to be limiting in any way.

[0100] In some embodiments, an exemplary shoulder spacer 300 comprises a body 302 having a lateral end / distal end 304 and a medial end / proximal end 306. In some embodiments, the body 302 comprises a posterior side 312 and an anterior side 314. In some embodiments, 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. In some embodiments, the posterior wing 308 and / or the anterior wing 310 do not protrude in the cranial / superior direction. In some embodiments, the protrusions extend in a width direction (arrow 320) in relation to a longitudinal axis 322 of the device. In some embodiments, 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). In some embodiments, 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. In some embodiments, the protrusions can extend at any angle ±90 degrees in relation to the longitudinal axis of the device.

[0101] In some embodiments, as mentioned before, 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. In some embodiments, the at least two protrusions are positioned in two different sides in relation to each to each other on the body. In some embodiments, 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 than the second part. In some embodiments, the body comprises a cross shape. In some embodiments, the body comprises a misaligned cross shape.

[0102] In some embodiments, the body is solid with a topological genus zero shape, meaning it has no orifices. In some embodiments, the body comprises natural occurring indentations or cavities generated by the materials used in the device. In some embodiments, the device comprises orifices as explained below.

[0103] In some embodiments, 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.

[0104] In some embodiments, the shoulder spacer comprises a smooth surface. In some embodiments, edges of the body of the shoulder spacer are rounded.

[0105] In some embodiments, device is configured to float within the body after implantation.

[0106] In some embodiments, the body is curved so the protrusions face each other.

[0107] 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.

[0108] In some embodiments, 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. In some embodiments, 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. In some embodiments, 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. In some embodiments, 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. In some embodiments, the anterior "wing" 310 is configured to be positioned in the pocket of the anterior shoulder joint capsule and subscapularis. In some embodiments, the posterior wing 308 is configured to be positioned in the pocket of the posterior shoulder joint capsule and teres minor. In some embodiments, the superior surface / upper surface 324 of the device is configured to face the Acromion and deltoid attachments. In some embodiments, the inferior surface / lower surface 326 of the device is configured to face the humeral head.

[0109] In some embodiments, 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. In some embodiments, 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. In some embodiments, parts of the protrusions (wings) 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.

[0110] Referring now to Figure 5, showing a schematic representation of exemplary sizes of an exemplary shoulder spacer 300, according to some embodiments of the invention. In some embodiments, exemplary sizes of the exemplary shoulder spacer 300 are as follows:

[0111] 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.

[0112] 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.

[0113] 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.

[0114] 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.

[0115] An overall thickness of from about 10mm to about 12mm, optionally form about 8mm to bout 14mm, optionally forma bout 6mm to about 16mm, and any value in between. For example a thickness of 11mm, 11.5mm, 12.5mm.

[0116] In some embodiments, 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.

[0117] In some embodiments, 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.

[0118] In some embodiments, 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.

[0119] In some embodiments, 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.

[0120] In some embodiments, 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.

[0121] In some embodiments, 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.

[0122] Referring now to 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. In some embodiments, the device is prepared a priori having a flat configuration. This means that under no external forces, the device naturally achieves a flat configuration.

[0123] Figure 6b shows an exemplary shoulder spacer comprising a convex configuration. In some embodiments, 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.

[0124] Figure 6c shows an exemplary shoulder spacer comprising a convex configuration. In some embodiments, 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.

[0125] Figure 6d shows an exemplary shoulder spacer comprising a flat configuration. In some embodiments, 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.

[0126] Figure 6g shows an exemplary shoulder spacer comprising a convex configuration. In some embodiments, 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.

[0127] Figure 6h shows an exemplary shoulder spacer comprising a convex configuration. In some embodiments, 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.

[0128] 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.

[0129] 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

[0130] Referring now to Figure 7, showing a schematic representation of the use of a double shoulder spacer, according to some embodiments of the invention. In some embodiments, more than one device is used in order to fill-in the desired space within the shoulder. In Figure 7, two shoulder spacers 702 / 704 are shown, one on top of the other. In some embodiments, a first device is rolled and installed, for example, arthroscopically via a ~lcm diameter portal. In some embodiments, a second device will be located on top or under the first one without the need of any connection between them. In some embodiments, 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. In some embodiments, 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. In some embodiments, optionally, 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.

[0131] Exemplary use of the shoulder spacer in addition to RTC repair

[0132] In some embodiments, the exemplary shoulder spacer show 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). In some embodiments, a potential advantage of using the exemplary shoulder spacers is that it can potentially provide protection to the repair while it heals.

[0133] Exemplary mechanical characteristics of an exemplary shoulder spacer 300

[0134] In some embodiments, the device is configured to resist the pressure developed under physiological loads. In some embodiments, the shoulder spacer is made of pliable materials. In some embodiments, the shoulder spacer is made of a single uniform material. In some embodiments, the shoulder spacer is made of two or more materials. In some embodiments, 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. The preferred polymers 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. 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. Such 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. Additionally, optionally and / or alternatively, the device can be manufactured from natural, biocompatible and / or biodegradable materials such as collagen, agarose, poly(ethylene-glycol)(PEG) and / or methyl cellulose. In some exemplary embodiments of the invention, the device is manufactured from at least one non-biodegradable material such as polyethylene (PE), polyurethane (PU), silicon (Si), Dyneema® and / or Kevlar®.

[0135] In some embodiments, 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. In some embodiments, 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.

[0136] In some embodiments, 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. In some embodiments, under maximal pressure, the area under pressure will allow up to 50% thickness decrease, for example a decrease of 5-6 mm, under weight-bearing.

[0137] In some embodiments, 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:

[0138] An exemplary shoulder spacer 300 is configured to resist a pick force of ~50 Newton;

[0139] 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;

[0140] 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.

[0141] Exemplary absorption qualities of an exemplary shoulder spacer 300

[0142] In some embodiments, an exemplary shoulder spacer 300 is made of materials that absorb liquids that cause an increment in the size of the shoulder spacer 300. In some embodiments, 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. In some embodiments, 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. In some embodiments, the device irreversibly increases its size. In some embodiments, an exemplary shoulder spacer can both irreversibly increase its size and degrade over time (see below explanations about degradation). In some embodiments, exemplary materials used for the absorption qualities are hydrogels, for example: Poly(Acrylic Acid) having an average Viscosity average molecular weight (Mv) of 4000000, 3000000, 1250000, 450000, or any combination thereof; or for example Collagen-based absorbable materials; or for example any other suitable absorbable material.

[0143] Exemplary methods of delivery of an exemplary shoulder spacer 300

[0144] In some embodiments, 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. In some embodiments, in order to allow an arthroscopic approach, 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. In some embodiments, when inserted using mini-open procedure, the device will be inserted through the incision manually by the surgeon. In some embodiments, once the device is inserted, the device is released to a deployed state, naturally occupying the area in the shoulder. In some embodiments, an exemplary shoulder spacer 300 is delivered without the need of a dedicated delivery system.

[0145] Exemplary sponge-based shoulder spacer

[0146] In some embodiments, an exemplary shoulder spacer 300 is made from sponge and / or sponge-like materials (referred hereinafter as sponge-based shoulder spacer). In some embodiments, the exemplary sponge-based shoulder spacer is manufactured having the desired dimensions when in a deployed state. In some embodiments, the exemplary sponge-based shoulder spacer is configured to be compressed in order to bring the device to an undeployed state. In some embodiments, the undeployed state comprises a shape of a cylinder. In some embodiments, 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. In some embodiments, in a deployed state, the exemplary sponge-based shoulder spacer preserves a thickness of about 5mm under peak force developed in the shoulder during range-of-motion in weight bearing. In some embodiments, the exemplary sponge-based shoulder is manufactured using 3D printing technology.

[0147] Exemplary reinforced shell shoulder spacer

[0148] Referring now to Figures 8a-d showing images of exemplary reinforced shell shoulder spacers, according to some embodiments of the invention. 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); and Figure 8d is a close view of the area marked in Figure 8c.

[0149] In some embodiments, an exemplary reinforced shell shoulder spacer comprises an external envelope 802, a plurality of internal reinforcing structures, macro-pores and / or micro-pores. In some embodiments, 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).

[0150] Referring now to Figures 8e-g showing exemplary internal organization of exemplary reinforced shell shoulder spacers, according to some embodiments of the invention. In some embodiments, the reinforced shell shoulder spacer comprises the external envelope 802. In some embodiments, within the external envelope 802 there are a plurality of internal reinforcement structures 806 extending within the external envelope 802. In some embodiments, between the internal reinforcement structures 806, macro-pores are generated 808 in the space absent of the internal reinforcement structures 806. In some embodiments, the whole reinforced shell shoulder spacer is made of a material that comprises micro-pores 810.

[0151] In some embodiments, the internal reinforcement structures 806 are generated having a dedicated geometry. For example, in Figure 8e 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. In Figure 8g, 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”.

[0152] 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.

[0153] In some embodiments, 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. In some embodiments, 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.

[0154] Exemplary general range of the internal reinforcement structures and the Micro / Macro-pores

[0155] Exemplary reinforced shell with hollowed external structure

[0156] Referring now to Figure 9a-c showing a schematic representation of an exemplary reinforced shell with hollowed external structure, according to some embodiments of the invention. In some embodiments, 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. In some embodiments, 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. In some embodiments, 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. In some embodiments, the orifices 902 can be generated through cut, drilling etc., or be part of the mold inserts in injection molding or a similar method. In some embodiments, 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. In some embodiments, optionally, 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. In some embodiments, the positioning of the superior macro-pores is “negative” to the position of the inferior macro-pores (as shown for example in Figure 9c).

[0157] Exemplary biodegradable shoulder spacer

[0158] In some embodiments, an exemplary shoulder spacer is optionally made of a biodegradable material (the device can be made of either biodegradable or non-biodegradable materials).

[0159] In some embodiments, 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. In some embodiments, 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.

[0160] In some embodiments, 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. In some embodiments, 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.

[0161] Referring now to Figures lOa-f, showing schematic representations of exemplary structures of exemplary shoulder spacers, according to some embodiments of the invention.

[0162] In some embodiments, as mentioned above, an exemplary shoulder spacer is made of biodegradable materials and is designed to degrade gradually and / or in a controlled manner.

[0163] In some embodiments, controlling the rate of degradation is performed by providing the exemplary shoulder spacer with a single body having a known degradation rate.

[0164] In some embodiments, 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. In some embodiments, 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. For example, when setting a degradation rate according to the thickness, 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. In some embodiments, 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).

[0165] In some embodiments, 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. In some embodiments, 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.

[0166] In some embodiments, 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. For example, as shown for example in Figure 10b, after a predetermined period of time, the lower layer 1004 will degrade exposing the next layer, layer 1006. Then, as shown for example in Figure 10c, after a predetermined period of time, the layer 1006 will degrade exposing the next layer, layer 1008. In some embodiments, the degradation process continues until all the layers degrade or until reaching the top layer 1002 when configured to not degrade.

[0167] In some embodiments, 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. Then, as shown for example in Figure lOf, after a predetermined period of time, the layers 1014 will degrade exposing the next layer, layers 1016. In some embodiments, the degradation process continues until all the layers degrade or until reaching the center layer 1018 when configured to not degrade.

[0168] Exemplary degradation rate

[0169] In some embodiments, the degradation rate is set a priori according to the type and / or composition and / or thickness of the layer of the materials used.

[0170] In the following tables, exemplary degradation rates are shown. It should be understood that the following tables are examples only. Different degradation rates are also within the scope of the invention and these examples are brought in order to allow a person having skills in the art to understand the invention.

[0171] In some embodiments, the degradation of the shoulder spacer comprises a reduction in thickness, rather than isotropic degradation. In some embodiments, a potential advantage of this is that the device degrades while keeping the natural anchoring achieved by the geometry of the device. Exemplary non-biode gradable shoulder spacer

[0172] In some embodiments, 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. In some embodiments, 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. In some embodiments, optionally, the scaffold comprises one or more of growth factors, drugs or similar agents to accelerate cell growth within the structure.

[0173] Exemplary in-situ fillable shoulder spacer

[0174] Referring now to Figure 11, showing an exemplary fillable shoulder spacer 1100, according to some embodiments of the invention. In some embodiments, an exemplary shoulder spacer 1100 comprises a fillable body (referred hereinafter as fillable shoulder spacer 1100). In some embodiments, an exemplary form of the body of the fillable body is as shown for example in Figures 3, 6a-j and 8a-k. In some embodiments, 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. In some embodiments, the opening can be located at any position on the surface of the fillable shoulder spacer 1100. In some embodiments, similar to what was disclosed above, 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. In some embodiments, 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. In some embodiments, 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. In some embodiments, 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.

[0175] In some embodiments, 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.

[0176] Exemplary vacuum feature for arthroscopic installations

[0177] In some embodiments, 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. In some embodiments, 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.

[0178] Exemplary method of manufacturing of an exemplary shoulder spacer

[0179] In some embodiments, 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.

[0180] Exemplary method of implanting an exemplary shoulder spacer

[0181] Referring now to Figure 12, showing a flowchart of an exemplary implantation method of an exemplary shoulder spacer, according to some embodiments of the invention.

[0182] In some embodiments, implanting an exemplary shoulder spacer, whatever configuration from the configurations described above, comprises one or more of the following actions:

[0183] 1. Providing a shoulder spacer in an undeployed configuration 1202;

[0184] 2. Placing the shoulder spacer in the shoulder 1204;

[0185] 3. Bringing the shoulder spacer from the undeployed configuration to a deployed configuration 706;

[0186] 4. Positioning parts of the shoulder spacer in their predetermined positions within the shoulder. In some embodiments, the parts of the shoulder spacer are the medial region 306, the lateral region 304, the anterior wing 310, the posterior wing 308, the superior surface and the inferior surface. In some embodiments, 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.

[0187] In some embodiments, when the device is an absorbable device, then the method further comprises exposing the shoulder spacer to liquids thereby allowing the body of the shoulder spacer to absorb the liquids.

[0188] In some embodiments, when the device comprises a hollow body and comprises an opening, 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.

[0189] As used herein with reference to quantity or value, the term “about” means “within ± 20 % of’.

[0190] The terms “comprises”, “comprising”, “includes”, “including”, “has”, “having” and their conjugates mean “including but not limited to”.

[0191] The term “consisting of’ means “including and limited to”.

[0192] The term “consisting essentially of’ means that the composition, method or structure may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

[0193] As used herein, the singular forms “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof.

[0194] Throughout this application, embodiments of this invention may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as “from 1 to 6” should be considered to have specifically disclosed subranges such as “from 1 to 3”, “from 1 to 4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc.; as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range. Whenever a numerical range is indicated herein (for example “10-15”, “10 to 15”, or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases “range / ranging / ranges between” a first indicate number and a second indicate number and “range / ranging / ranges from” a first indicate number “to”, “up to”, “until” or “through” (or another such range-indicating term) a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numbers therebetween.

[0195] Unless otherwise indicated, numbers used herein and any number ranges based thereon are approximations within the accuracy of reasonable measurement and rounding errors as understood by persons skilled in the art.

[0196] As used herein the term “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.

[0197] As used herein, the term “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.

[0198] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

[0199] Various embodiments and aspects of the present invention as delineated hereinabove and as claimed in the claims section below find experimental support in the following examples.

[0200] EXAMPLES

[0201] Reference is now made to the following examples, which together with the above descriptions illustrate some embodiments of the invention in a non limiting fashion. Exemplary Main User Input and Design Input:

[0202] 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)

[0203] 2. MRI analyses in terms of morphological and size

[0204] 3. Analyses of other patient parameters: gender, age, weight, activity level, and relevant medical history

[0205] 4. Overall analyses and calculations in order to design the optimal device for the specific patient in terms of (all or part): size, shape, thickness, general stiffness, articulating surfaces roughness, degradable or permanent, functionality time (if relevant), degradation time (if relevant), and surgical planning. Exemplary manufacturing method:

[0206] Using a dissolvable mold:

[0207] A dissolvable core with the “negative” shape of the internal reinforcement + external permanent mold that will be used to shape the external surfaces. The process:

[0208] 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.

[0209] 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.

[0210] Step III - Releasing the injected polymer from the permanent mold.

[0211] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0212] It is the intent of the applicant(s) that all publications, patents and patent applications referred to in this specification are to be incorporated in their entirety by reference into the specification, as if each individual publication, patent or patent application was specifically and individually noted when referenced that it is to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is / are hereby incorporated herein by reference in its / their entirety.

Claims

WHAT IS CLAIMED IS:

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.

2. The shoulder spacer according to claim 1, wherein said at least two protrusions are positioned in two different sides in relation to each to each other on said body.

3. The shoulder spacer according to claim 1, 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.

4. The shoulder spacer according to claim 3, wherein said first part is smaller than said second part.

5. The shoulder spacer according to claim 1, wherein said body comprises a cross shape.

6. The shoulder spacer according to claim 1, wherein said body is solid with a topological genus zero shape.

7. The shoulder spacer according to claim 1, wherein said elongated planar body comprises an upper surface and a lower surface.

8. The shoulder spacer according to claim 7, wherein said body comprises a plurality of orifices extending from said upper surface to said lower surface.

9. The shoulder spacer according to claim 7, 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.

10. The shoulder spacer according to claim 9, wherein locations of said upper orifices are intercalated with locations of said lower orifices.

11. The shoulder spacer according to claim 1, wherein said body is not inflatable.

12. The shoulder spacer according to claim 1, wherein said body is pliable.

13. The shoulder spacer according to claim 1, wherein said body comprises a width from 1cm to 12cm.

14. The shoulder spacer according to claim 1, wherein said body comprises a thickness from 6mm to 16mm.

15. The shoulder spacer according to claim 1, wherein said body comprises a length up to 12cm.

16. The shoulder spacer according to claim 1, wherein body is made of a single uniform material.

17. The shoulder spacer according to claim 1, wherein body is made of two or more materials.

18. The shoulder spacer according to claim 17, wherein at least one of said two or more materials is a coating material.

19. The shoulder spacer according to claim 1, wherein surfaces of said body are smooth.

20. The shoulder spacer according to claim 1, wherein edges of said body are rounded.

21. The shoulder spacer according to claim 1, wherein said device is configured to float within the body after implantation.

22. The shoulder spacer according to claim 1, wherein said body is curved so said protrusions face each other.

23. The shoulder spacer according to claim 1, wherein said protrusions comprise a length of from about 1cm to about 6cm measured from lateral side of the body.

24. The shoulder spacer according to claim 1, wherein said shoulder spacer comprises an undeployed configuration and a deployed configuration.

25. The shoulder spacer according to claim 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.

26. The shoulder spacer according to claim 1, wherein said proximal end of said body is configured to be positioned on a Glenoid rim, adjacent to a medial retracted stump of a torn cuff.

27. The shoulder spacer according to claim 1, 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.

28. The shoulder spacer according to claim 1, 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.

29. The shoulder spacer according to claim 1, 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.

30. The shoulder spacer according to claim 7, wherein said upper surface is configured to face an Acromion and deltoid attachments.

31. The shoulder spacer according to claim 7, wherein said lower surface is configured to face a humeral head.

32. The shoulder spacer according to claim 1, wherein said body comprises a plurality of layers.

33. The shoulder spacer according to claim 32, wherein each of said plurality of layers is configured to degrade.

34. The shoulder spacer according to claim 33, wherein said degrade is according to a predetermined time period dictated by a material of each of said plurality of layers.

35. The shoulder spacer according to claim 24, 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.

36. The shoulder spacer according to claim 24, 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.

37. The shoulder spacer according to claim 24, 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.

38. The shoulder spacer according to claim 1, 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.

39. The shoulder spacer according to claim 1, wherein said body is made of a material comprising micro-pores.

40. The shoulder spacer according to claim 38, 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.

41. A method for implanting a shoulder spacer in a human shoulder, the method comprising: a. providing a shoulder spacer according to claim 1, comprising a body having a proximal end, a distal end, at least two protrusions, an upper surface and a lower surface, in an undeployed configuration; b. placing said shoulder spacer in said shoulder; c. bringing said shoulder spacer from said undeployed configuration to a deployed configuration; wherein said bringing said shoulder spacer to said deployed configuration comprises positioning said proximal end, said distal end, said at least two protrusions, said upper surface and said lower surface, each in a predetermined location within said shoulder.

42. The method according to claim 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.

43. The method according to claim 41, 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.

44. The method according to claim 41, 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.

45. The method according to claim 41, 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.

46. The method according to claim 41, wherein said predetermined location of said upper surface is facing an Acromion and deltoid attachments.

47. The method according to claim 41, wherein said predetermined location of said lower surface is facing a humeral head.

48. The method according to claim 41, wherein said bringing said shoulder spacer from said undeployed configuration to a deployed configuration comprises exposing said shoulder spacer to liquids thereby allowing said body of said shoulder spacer to absorb said liquids.

49. The method according to claim 41, wherein said bringing said shoulder spacer from said undeployed configuration to a deployed configuration comprises inserting liquids within at least one cavity in said shoulder spacer.

50. The method according to claim 41 , further comprising bringing said shoulder spacer to an undeployed configuration by extracting air from within said body.

51. The method according to claim 50, wherein said bringing said shoulder spacer to an undeployed configuration comprises rolling said body.

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