Shoulder spacer

Abstract

The invention relates to a shoulder spacer comprising a body having an undeployed configuration and a deployed configuration; wherein in the deployed configuration, the body has a size and shape occupying a predetermined space and location within the shoulder and between the at least two bones. The main body of the shoulder spacer has an inner region, an outer region, a front wing portion, a rear wing portion, an upper side surface, and a lower side surface.

Description

[0001] Related applications

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 525,736, filed July 10, 2023, the contents of which are incorporated herein by reference in their entirety.

[0003] Field and background of the invention Technical Field

[0004] In some embodiments, the present invention relates to a shoulder spacer, and more particularly, but not exclusively, to a stable and reliable shoulder spacer. Background Technology

[0005] Rotator cuff tears (RCTs) are a common injury affecting approximately 2 million people in the United States each year. About 1 million require surgical intervention and are classified into four severity categories: small, moderate, large, or massive. A massive tear is defined as a tear with a distance of more than 5 cm between the tear edge and the humeral head, involving two or more tendons (most commonly the upper tendon). Of the one million RCT patients, 25-30% have massive tears (15-20% are irreparable, and 10% are repairable).

[0006] When the arm is raised, RCT patients will lack the focusing mechanism of the rotator cuff tendons. The humeral head can move upward and collide with the acromion, as... Figure 1 As shown. This eventually leads to pain, and ultimately to functional limitations and disability in the patient's range of motion.

[0007] Further background art includes U.S. Patent No. US8894713B2, which discloses an apparatus and method for a shoulder implant, such as for the glenohumeral joint. The implant is expandable and contractible during implantation. The implant is sized to fit the glenoid fossa. Implant selection and / or implantation involves adjusting the size and function of the implant to meet the specific needs of the patient.

[0008] US Patent No. 9314944B2 discloses a tissue transfer / separation device. The device includes a sac that can expand between a first tissue and a second tissue in the body. The sac has an expanded shape selected to allow for the transfer or separation of the first tissue from the second tissue in a manner suitable for protecting the first tissue from therapeutic effects applied to the second tissue.

[0009] US Patent No. 8753390B2 discloses a prosthesis for reducing soft tissue injuries, comprising an implantable member adapted to mimic at least one of the dimensions and shapes of a naturally occurring sac. This member may be inflatable or otherwise expandable, flexible or rigid, and may be made of biocompatible, biodegradable, or non-biodegradable materials. The member is adapted for implantation at a musculoskeletal attachment site or at a site between muscle and bone, and its shape and size are adapted to reduce injury to that site. The prosthesis may also include a plug that automatically seals the prosthesis upon removal of the inflation tube.

[0010] U.S. Patent Application Publication No. US20110295379A1 discloses a soft, expandable, implantable device sized to accommodate the space between small bones, including a first smooth surface on which the first small bone can slide. The implant includes an opening (channel) extending through the device to facilitate fibrosis development from both the thumb metacarpal and trapezium bones. The channel is optionally located distal to a one-way expansion valve contained within an expansion port, thereby significantly limiting potential damage to the device due to insertion pressure of the expansion fluid. An expansion cannula and / or needle may be attached to the expansion port and expansion valve for introducing expansion fluid into the device. The implant is inserted in a contracted mode and positioned such that, upon expansion, the thumb metacarpal abuts against the distal side of the device, and the trapezium abuts against the proximal side. Both the distal and proximal sides include smooth surfaces to allow relative movement of the thumb metacarpal and trapezium bones relative to the device.

[0011] U.S. Patent Application Publication No. US20130331946A1 discloses an expandable implantable device sized to occupy a space in a cavity formed between the small bones of a human hand or foot. It includes a first smooth surface on which the first small bone can slide. An opening extending through the device may be included for promoting fibrosis development from both the thumb metacarpal and trapezium bones. An expansion cannula and / or needle may be attached to an expansion port and an expansion valve for introducing expansion fluid into the device. The implant is inserted in a contracted mode and positioned such that, upon expansion, the thumb metacarpal abuts against the distal side of the device, and the trapezium abuts against the proximal side of the device. At least one of the distal and proximal sides includes a smooth surface to allow relative movement of the thumb metacarpal and / or trapezium bones relative to the device.

[0012] US Patent No. 11033398B2 discloses a shoulder implant for simulating or replacing a naturally occurring sac in the subacromial bursa. The shoulder implant includes: an expandable member of a size and / or shape that can expand to fill a space below the acromion and / or coracoid process of the shoulder, the space defining a fill volume smaller than the maximum volume occupied by the expandable member when fully expanded; and a quantity of filler for filling the expandable member into the fill volume. The expandable member is configured to cushion and facilitate movement between the tendons and / or ligaments of the rotator cuff and the bony portion of the shoulder when implanted.

[0013] International Patent Application No. WO2012017438A1 discloses a device and method for shoulder implantation, such as for the glenohumeral joint. Optionally, the implant can expand and contract during implantation. Optionally, the implant is sized to fit the glenoid fossa. In exemplary embodiments of the invention, implant selection and / or implantation includes adjusting the size and function of the implant according to the needs of a particular patient.

[0014] US Patent No. 10492916B2 discloses a shoulder implant for reconstructing the coracoacromial arch in a subject. The shoulder implant includes: a dorsal surface substantially shaped to the coracoacromial arch of the shoulder, which, when implanted in the subject, serves to engage at least a posterior portion of the acromion; and a lower surface substantially shaped to the scapuhumeral arch of the shoulder, opposite the dorsal surface. The implant may have a spacer with a raised / convex shape to mimic the anatomical contour of the scapuhumeral arch, and the spacer is coupled to a base plate. In some embodiments, the base plate and spacer have convex surfaces that extend the length of the lower surface of the acromion and are anterior to the coracoid process.

[0015] US Patent No. 11241256B2 discloses a selectively placed implant specifically configured and sized to address shoulder pathology caused by inappropriate force distribution. By using a properly sized and positioned implant, targeted connective and muscular tissues in the shoulder are repositioned to readjust the force vector and / or alter the lever arm of the loaded joint, thereby achieving therapeutic effects without cutting bone and with minimal obstruction of connective tissue.

[0016] US Patent No. 10959761B2 discloses a prosthesis comprising: a subacromial spacer having a surface profile that holds the acromion at a selected distance from the humeral head during acromial rotation; and a fixation mechanism for securing the subacromial spacer to the humeral medullary cavity and / or implanting or configuring an intramedullary fixator for implantation into the humeral medullary cavity. The surgical kit includes the prosthesis and a proximal intramedullary nail / proximal humeral screw. The fixation mechanism can be connected to a proximal opening of the proximal humeral screw. One method may include: creating a percutaneous channel from an external space to a portion of the humeral head; removing bone tissue to facilitate direct communication between the external space and the humeral medullary cavity surrounding the humeral head; providing a prosthesis including a subacromial spacer having a surface; and / or securing the subacromial spacer to the humeral medullary cavity and / or implanting or configuring an intramedullary fixator for implantation into the humeral medullary cavity.

[0017] US Patent No. 9872773B2 discloses an orthopedic implant and system. This document discloses methods for designing, manufacturing, modeling, and implanting the implant, as well as surgical tools and kits used therewith. The implant is designed by analyzing the joint surface to be corrected and creating a device with anatomical or near-anatomical fit; or by selecting a pre-designed implant with features that best suit the existing defect.

[0018] U.S. Patent Application No. US20210030553A1 discloses a glenoid implant comprising a body and a flange. The body includes a supporting surface and a bone contact surface opposite the supporting surface. The flange extends from the bone contact surface of the body to a free end. The flange has an inwardly facing surface facing the center of the body and an outwardly facing surface facing the outer periphery of the body. The outwardly facing surface is opposite the inwardly facing surface, and each of the inwardly facing surface and the outwardly facing surface extends from the bone contact surface to the free end. The outwardly facing surface at the bone contact surface of the body is 8 mm or closer to the outer periphery of the body. The outwardly facing surface tapers gradually from the bone contact surface towards the free end. The inwardly facing surface is not parallel to the outwardly facing surface.

[0019] US Patent No. 6712854B2 discloses an acromion-humeral prosthesis for performing acromion-humeral arthroplasty. This prosthesis is used in cases where extensive, irreparable rotator cuff tears have occurred. The primary function of the prosthesis is to prevent superior displacement of the humeral head. An acromion tray is inserted using a specialized insertion tool. The acromion tray is held in place by a pair of screws against a prepared lower surface of the acromion. The component is secured to the bottom of the acromion tray by sliding a disc-shaped polymer component recessed on one or more matching tracks on the lower surface of the acromion tray. This component is released to receive the long head of the biceps tendon anteriorly and the greater trochanter laterally. The prosthesis of this invention helps prevent non-anatomical arthroplasty of the humerus and other inappropriate glenohumeral kinematics. Summary of the Invention

[0020] The following is a non-exclusive list of some examples including embodiments of the present invention. The invention also includes embodiments that incorporate all features from fewer than one example, and embodiments that use features from multiple examples, although not explicitly listed below.

[0021] Example 1. A shoulder spacer comprising:

[0022] a. A slender planar body extending along a longitudinal axis between the proximal and distal ends;

[0023] b. At least two protrusions, each extending in a width direction perpendicular to the longitudinal axis, the at least two protrusions being located between the proximal end and the distal end.

[0024] Example 2. The shoulder spacer according to Example 1, wherein the at least two protrusions are positioned on the body on opposite sides of each other.

[0025] Example 3. A shoulder spacer according to Example 1 or Example 2, wherein a first portion of the body extends proximally beyond the protrusion toward the proximal end, and a second portion of the body extends distally beyond the protrusion toward the distal end.

[0026] Example 4. A shoulder spacer according to any one of Examples 1-3, wherein the first portion is smaller than the second portion.

[0027] Example 5. A shoulder spacer according to any one of Examples 1-4, wherein the body is cross-shaped.

[0028] Example 6. A shoulder spacer according to any one of Examples 1-5, wherein the body is a solid structure having a shape with a topological genus of zero.

[0029] Example 7. A shoulder spacer according to any one of Examples 1-6, wherein the elongated planar body includes an upper surface and a lower surface.

[0030] Example 8. A shoulder spacer according to any one of Examples 1-7, wherein the body includes a plurality of openings extending from the upper surface to the lower surface.

[0031] Example 9. A shoulder spacer according to any one of Examples 1-8, wherein the body includes a plurality of upper openings extending from the upper surface toward the lower surface portion and a plurality of lower openings extending from the lower surface toward the upper surface portion.

[0032] Example 10. A shoulder spacer according to any one of Examples 1-9, wherein the positions of the upper orifice and the lower orifice are staggered.

[0033] Example 11. A shoulder spacer according to any one of Examples 1-10, wherein the body is non-inflatable.

[0034] Example 12. A shoulder spacer according to any one of Examples 1-11, wherein the body is flexible.

[0035] Example 13. A shoulder spacer according to any one of Examples 1-12, wherein the body has a width of 1 cm to 12 cm.

[0036] Example 14. A shoulder spacer according to any one of Examples 1-13, wherein the body has a thickness of 6 mm to 16 mm.

[0037] Example 15. A shoulder spacer according to any one of Examples 1-14, wherein the body has a length of up to 12 cm.

[0038] Example 16. A shoulder spacer according to any one of Examples 1-15, wherein the body is made of a single homogeneous material.

[0039] Example 17. A shoulder spacer according to any one of Examples 1-16, wherein the body is made of two or more materials.

[0040] Example 18. A shoulder spacer according to any one of Examples 1-17, wherein at least one of the two or more materials is a coating material.

[0041] Example 19. A shoulder spacer according to any one of Examples 1-18, wherein the surface of the body is smooth.

[0042] Example 20. A shoulder spacer according to any one of Examples 1-19, wherein the edges of the body are rounded.

[0043] Example 21. A shoulder spacer according to any one of Examples 1-20, wherein the device is configured to float within the body after implantation.

[0044] Example 22. A shoulder spacer according to any one of Examples 1-21, wherein the body is curved such that the protrusions face each other.

[0045] Example 23. A shoulder spacer according to any one of Examples 1-22, wherein the protrusion comprises a length of about 1 cm to about 6 cm measured from the side of the body.

[0046] Example 24. A shoulder spacer according to any one of Examples 1-23, wherein the shoulder spacer includes an undeployed configuration and a deployed configuration.

[0047] Example 25. A shoulder spacer according to any one of Examples 1-24, wherein, in the unfolded configuration, the body has dimensions and shape configured to occupy a predetermined space and position within the shoulder and between at least two bones.

[0048] Example 26. A shoulder spacer according to any one of Examples 1-25, wherein the proximal end of the body is configured to be positioned adjacent to the medial retracted end of a torn rotator cuff on the glenoid rim.

[0049] Example 27. A shoulder spacer according to any one of Examples 1-26, wherein the distal end of the body is configured to be positioned near the lateral remnant / lateral stump of the rotator cuff attached to the humeral head and the inner layer of the deltoid muscle.

[0050] Example 28. A shoulder spacer according to any one of Examples 1-27, wherein one of the at least two protrusions is configured to be positioned within a pouch formed by the anterior shoulder joint capsule and the subscapularis muscle.

[0051] Example 29. A shoulder spacer according to any one of Examples 1-28, wherein one of the at least two protrusions is configured to be positioned within a pouch formed by the posterior shoulder joint capsule and the teres minor muscle.

[0052] Example 30. A shoulder spacer according to any one of Examples 1-29, wherein the upper surface is configured to face the attachment point of the acromion and deltoid muscle.

[0053] Example 31. A shoulder spacer according to any one of Examples 1-30, wherein the lower surface is configured to face the humeral head.

[0054] Example 32. A shoulder spacer according to any one of Examples 1-31, wherein the body comprises a plurality of layers.

[0055] Example 33. A shoulder spacer according to any one of Examples 1-32, wherein each of the plurality of layers is configured to be degradable.

[0056] Example 34. A shoulder spacer according to any one of Examples 1-33, wherein the degradation is carried out over a predetermined time period determined by the material of each of the plurality of layers.

[0057] Example 35. A shoulder spacer according to any one of Examples 1-34, wherein the body is made of an absorbent material; wherein the transition from the undeployed configuration to the deployed configuration is characterized by the body absorbing liquid.

[0058] Example 36. A shoulder spacer according to any one of Examples 1-35, wherein the body is a hollow body; wherein the hollow body includes an opening configured to allow liquid and / or air to enter the body in order to perform a transition from the undeployed configuration to the deployed configuration.

[0059] Example 37. A shoulder spacer according to any one of Examples 1-36, wherein the body is a hollow body; wherein the hollow body includes an opening configured to allow air to be extracted from the body in order to perform a transition from the deployed configuration to the undeployed configuration.

[0060] Example 38. A shoulder spacer according to any one of Examples 1-37, wherein the body includes an outer shell, a plurality of internal reinforcement structures, and a plurality of large holes located between the plurality of internal reinforcement structures.

[0061] Example 39. A shoulder spacer according to any one of Examples 1-38, wherein the body is made of a material including micropores.

[0062] Example 40. A shoulder spacer according to any one of Examples 1-39, wherein the plurality of internal reinforcement structures are positioned to provide structural reinforcement to locations on the outer casing where a higher expected pressure level is desired.

[0063] Example 41. A method for implanting a shoulder spacer in a human shoulder, the method comprising:

[0064] a. Providing a shoulder spacer according to any one of Examples 1-40 in an unexpanded configuration;

[0065] b. Place the shoulder spacer in the shoulder;

[0066] c. Change the shoulder spacer from the undeployed configuration to the deployed configuration;

[0067] Changing the shoulder spacer to the unfolded configuration includes positioning the proximal end, the distal end, the at least two protrusions, the upper surface, and the lower surface at predetermined positions within the shoulder.

[0068] Example 42. The method according to Example 41, wherein the predetermined position of the proximal end of the body is adjacent to the medial retraction stump of the torn rotator cuff located on the glenoid rim.

[0069] Example 43. The method according to Example 41 or Example 42, wherein the predetermined position of the distal end of the body is adjacent to the lateral remnant of the rotator cuff attached to the humeral head and the inner layer of the deltoid muscle.

[0070] Example 44. The method according to any one of Examples 41-43, wherein the predetermined position of one of the at least two protrusions is in a pouch formed by the anterior shoulder joint capsule and the subscapularis muscle.

[0071] Example 45. The method according to any one of Examples 41-44, wherein the predetermined position of one of the at least two protrusions is in a pouch formed by the posterior shoulder joint capsule and the teres minor muscle.

[0072] Example 46. The method according to any one of Examples 41-45, wherein the predetermined position of the upper surface faces the attachment point of the acromion and deltoid muscle.

[0073] Example 47. The method according to any one of Examples 41-46, wherein the predetermined position of the lower surface faces the humeral head.

[0074] Example 48. The method according to any one of Examples 41-47, wherein changing the shoulder spacer from the undeployed configuration to the deployed configuration includes exposing the shoulder spacer to a liquid, thereby allowing the body of the shoulder spacer to absorb the liquid.

[0075] Example 49. The method according to any one of Examples 41-48, wherein changing the shoulder spacer from the undeployed configuration to the deployed configuration comprises injecting liquid into at least one cavity in the shoulder spacer.

[0076] Example 50. The method according to any one of Examples 41-49 further includes converting the shoulder spacer into an undeployed configuration by extracting air from the body.

[0077] Example 51. The method according to any one of Examples 41-50, wherein changing the shoulder spacer to an unexpanded configuration includes rolling up the body.

[0078] 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 this invention pertains. While similar or equivalent methods and materials may 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) shall prevail. Furthermore, materials, methods, and examples are illustrative only and are not intended to be restrictive. Attached Figure Description

[0079] Some embodiments of the invention are described herein by way of example only with reference to the accompanying drawings. Reference will now be made in detail to the drawings, and it is emphasized that the details shown are exemplary and intended for illustrative discussion of embodiments of the invention. In this respect, the description in conjunction with the drawings will make it clear to those skilled in the art how to implement embodiments of the invention.

[0080] In the attached diagram:

[0081] Figure 1 This is a schematic diagram of the movement of the humeral head toward the acromion;

[0082] Figure 2a -b is a schematic diagram of the direction reference that will be used in the explanation of the exemplary implementation;

[0083] Figure 3 This is a schematic diagram of an exemplary shoulder spacer according to some embodiments of the present invention;

[0084] Figure 4 This is a schematic diagram of an exemplary shoulder spacer positioned within the shoulder according to some embodiments of the present invention;

[0085] Figure 5 This is a schematic diagram of exemplary dimensions of an exemplary shoulder spacer according to some embodiments of the present invention;

[0086] Figure 6a -j is a schematic diagram of the exemplary geometry and curvature of an exemplary shoulder spacer according to some embodiments of the present invention;

[0087] Figure 7 This is a schematic diagram of the use of a double shoulder spacer according to some embodiments of the present invention;

[0088] Figure 8a -d is an image of an exemplary shoulder spacer with an enhanced housing according to some embodiments of the present invention;

[0089] Figure 8e -g is a schematic diagram of the exemplary internal organization of an exemplary shoulder spacer with a reinforced shell according to some embodiments of the present invention;

[0090] Figure 8h -k is a schematic diagram of two different exemplary embodiments of the internal reinforcement structure according to some embodiments of the present invention;

[0091] Figure 9a -c is a schematic diagram of an exemplary reinforced housing having a hollow external structure according to some embodiments of the present invention;

[0092] Figure 10a-f is a schematic diagram of an exemplary degradation process of an exemplary shoulder spacer according to some embodiments of the present invention;

[0093] Figure 11 This is a schematic diagram of an exemplary padded shoulder spacer according to some embodiments of the present invention; and

[0094] Figure 12 This is a flowchart of an exemplary method for implanting an exemplary shoulder spacer according to some embodiments of the present invention. Detailed Implementation

[0095] In some embodiments, the present invention relates to a shoulder spacer, and more particularly, but not exclusively, to a shoulder spacer configured to maintain a desired size over time.

[0096] Overview

[0097] One aspect of some embodiments of the present invention relates to an implantable device (hereinafter simply referred to as the "device") configured for positioning in the shoulder to provide necessary space and support between bones. In some embodiments, the device includes at least two states: an undeployed state in which the device includes a geometry that allows for easy manipulation and storage outside the patient, for example, within a delivery device; and an deployed state in which the device includes a geometry designed to occupy a predetermined location within the body (e.g., the shoulder) and situated in a predetermined space between at least two bones. In some embodiments, the geometry in the undeployed state allows for arthroscopic implantation, regardless of whether the device is inserted into a dedicated delivery system. In some embodiments, the device is designed such that, in the deployed state, one or more portions of the device occupy a specific space within the body, for example, in the shoulder region, to naturally fix or restrict movement of the device within that space and potentially prevent undesirable movement of the device therein. In some embodiments, in the deployed state, the device includes a predetermined curvature, which may optionally be independent of the geometry or form of the device. In some embodiments, the device includes one or more protrusions configured to occupy a specific area in the body. In some embodiments, the device includes a predetermined curvature, while in other embodiments, the device is flat and is allowed to passively acquire curvature. In some embodiments, the device in its undeployed state includes a first size, while the device in its deployed state includes a second size. In some embodiments, the second size is about 50% to about 500% larger than the first size. In some embodiments, the device is made of a biodegradable material. In some embodiments, the device is configured to degrade according to a predetermined degradation rate. In some embodiments, the device is configured not to degrade and is configured to remain implanted in the body for a long period or indefinitely.

[0098] One aspect of some embodiments of the present 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 this device is that it may provide minimally invasive treatment for managing RCTs, alleviate pain, promote proper shoulder mechanics, and improve the patient's overall health, allowing the deltoid muscle sufficient time to gradually adapt after a massive RCT. By providing structural support between the acromion and humeral head and by reducing pain during daily activities, this spacer can function without the need for sutures or fixation. In some embodiments, the device includes a specialized shape that matches or at least partially matches the intended space in which the device will be implanted. In some embodiments, the device is configured to interact with the associated soft tissue and bone structures. In some embodiments, the device is configured to fit seamlessly into the space, potentially ensuring optimal separation, such as optimal separation between the acromion and humeral head during full range of motion (ROM). In some implementations, the articulated surface of the device matches the contours of the humeral head and acromion to facilitate proper contact and potentially minimize stress, particularly maintaining stability during daily activities without the need for fixation.

[0099] One aspect of some embodiments of the present invention relates to a shoulder spacer made of a material including micropores, the shoulder spacer comprising a housing, a plurality of internal reinforcing structures, and large holes. In some embodiments, optionally, the number, location, and thickness of the internal reinforcing structures are set according to the expected magnitude and location of pressure on the device.

[0100] One aspect of some embodiments of the present invention relates to a shoulder spacer configured to occupy an anatomical region in the subacromial space between the glenoid rims, adjacent to the medial retracted end of a torn rotator cuff, and adjacent to the lateral end of the rotator cuff attached to the humeral head and the inner deltoid muscle, within the shoulder and between at least two bones. In some embodiments, the spacer includes an elongated planar body extending along a longitudinal axis between proximal and distal ends, the body having width and thickness. In some embodiments, the spacer includes at least two protrusions, each extending laterally and radially from the body for a length of about 1 cm to about 6 cm, each protrusion being flexible and including a rounded end. In some embodiments, the body is curved, so that the at least two protrusions face each other. In some embodiments, the shoulder spacer includes a cross shape. In some embodiments, the protrusions extend in a width direction perpendicular to the longitudinal axis. In some embodiments, the at least two protrusions are located between the proximal and distal ends. In some embodiments, the at least two protrusions are located on different sides of the body. In some embodiments, a first portion of the body extends proximally beyond the protrusion, and a second portion of the body extends distally beyond the protrusion. In some embodiments, the first portion is smaller than the second portion. In some embodiments, the protrusion comprises a length from about 1 cm to about 8 cm measured from the side / side of the body. In some embodiments, the body is a solid structure (without holes) of topological genus zero. In some embodiments, the body is non-inflatable / expandable. In some embodiments, the body is flexible. In some embodiments, the device has a width of about 1 cm to about 12 cm and a thickness of about 6 mm to about 16 mm. In some embodiments, the body comprises a length of up to 10 cm. In some embodiments, the body is made of a single homogeneous material. In some embodiments, the surface of the body is smooth, and the edges of the device are rounded. In some embodiments, the device is configured to float within the body after implantation.

[0101] In some embodiments, the shoulder spacer is made of and / or coated with a material that prevents the accumulation of tissue (e.g., fibrotic tissue) on the shoulder of the spacer. A potential advantage of this is that it allows the shoulder of the spacer to remain "floating" in the implantation area, which allows for dynamic function of the shoulder when needed. In some embodiments, the shoulder spacer is made of and / or coated with a material that promotes or partially promotes the accumulation of tissue (e.g., fibrotic tissue) on the shoulder of the spacer. A potential advantage of this is that it increases the natural anchorage of the device at the implantation site.

[0102] Before explaining at least one embodiment of the invention in detail, it should be understood that the invention is not necessarily limited in its application to the details of the construction and arrangement of the components and / or methods set forth in the following description and / or shown in the drawings and / or examples. The invention can have other embodiments, or can be practiced or performed in many different ways.

[0103] Now for reference Figure 2a This illustrates a schematic representation of directional references that will be used in the explanation of exemplary embodiments. In the following explanation, the orientation of the exemplary shoulder spacer will be provided relative to an anatomical reference. For example, for a shoulder spacer configured to be placed in the right shoulder, when “anterior” is mentioned, it refers to a direction toward the patient’s chest, and when “posterior” it refers to a direction toward the patient’s back, and when “lateral” it refers to a direction toward the outside of the patient’s body, and when “medial” it refers to a direction toward the inside of the patient’s body, following the pattern as follows: Figure 1 The directional reference is schematically shown in b. It should be understood that this also applies to the exemplary shoulder spacer configured to be placed in the left shoulder.

[0104] Also refer to Figure 2b This diagram illustrates an additional orientation reference that will be used in the explanation of exemplary embodiments. In the following explanation, the orientation of an exemplary shoulder spacer relative to the device itself will be provided; for example, the implant includes a body having a proximal end, a distal end, a superior surface, and a lower surface (in...). Figure 2b (Invisible in the middle), width, length, and thickness.

[0105] Finally, a combination of two reference systems can be used to provide those skilled 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 the proximal direction (also known as the medial direction) relative to the patient, while the distal end refers to the end located away from the patient (in the distal direction), also known as the lateral direction.

[0106] Now for reference Figure 3 The figures show schematic diagrams of exemplary shoulder spacers according to some embodiments of the present invention. In all the figures, the same parts have the same reference numerals.

[0107] The following explanation follows Figure 2a The directional references are as follows, and the following explanations are for illustrative purposes only and describe an exemplary shoulder spacer configured to be positioned in the right shoulder, and accordingly use the associated directional references. These are provided merely as examples to allow those skilled in the art to understand the invention and are not intended to limit it in any way.

[0108] In some embodiments, the exemplary shoulder spacer 300 includes a body 302 having a lateral / distal end 304 and a medial / proximal end 306. In some embodiments, the body 302 includes a posterior side 312 and an anterior side 314. In some embodiments, the exemplary shoulder spacer 300 includes one or more protrusions, such as a protruding region 308 (hereinafter referred to as the "posterior wing") extending posteriorly from the posterior side 312 and a protruding region 310 (hereinafter referred to as the "anterior wing") extending anteriorly from the anterior side 314. The regions of the posterior wing 308 and / or the anterior wing 310 are schematically marked by dashed lines 316 / 318. In some embodiments, the posterior wing 308 and / or the anterior wing 310 do not protrude in a cranial / superior direction.

[0109] In some embodiments, these protrusions extend in the width direction (arrow 320) relative to the longitudinal axis 322 of the device. In some embodiments, these protrusions may be positioned relative to each other and aligned with each other, or may be positioned relative to each other but misaligned (see below). In some embodiments, each protrusion may extend at any angle relative to the longitudinal axis of the device; for example, arrow 320 shows a protrusion extending at an angle of 90 degrees relative to the longitudinal axis. In some embodiments, the protrusions may extend at any angle within ±90 degrees relative to the longitudinal axis of the device.

[0110] In some embodiments, as previously described, the shoulder spacer includes: an elongated planar body extending along a longitudinal axis between a proximal and a distal end; and at least two protrusions, each extending in a width direction perpendicular to the longitudinal axis, the at least two protrusions being located between the proximal and distal ends. In some embodiments, the at least two protrusions are positioned on the body on opposite sides. In some embodiments, a first portion of the body extends proximally beyond the protrusions, and a second portion of the body extends distally beyond the protrusions. In some embodiments, the first portion is smaller than the second portion. In some embodiments, the body comprises a cross shape. In some embodiments, the body comprises a misaligned cross shape.

[0111] In some embodiments, the body is a solid structure with a shape of zero topological genus, meaning it has no openings. In some embodiments, the body includes naturally occurring indentations or cavities created by the material used in the device. In some embodiments, the device includes openings as described below.

[0112] In some implementations, the body is non-inflatable, or at least not intended to be inflated or does not need to be inflated in order to be properly deployed / unfolded at the shoulder.

[0113] In some embodiments, the shoulder spacer includes a smooth surface. In some embodiments, the edges of the body of the shoulder spacer are rounded.

[0114] In some implementations, the device is configured to float within the body after implantation.

[0115] In some implementations, the body is curved so that the protrusions face each other.

[0116] Figure 3 A top view of the exemplary device 300 is shown, illustrating the upper surface 324. The dashed arrows schematically point... Figure 3 The lower surface 326 is not visible in the middle.

[0117] In some implementations, the exemplary shoulder spacer 300 includes dimensions and shapes configured to occupy an anatomical region in the subacromial space, such as... Figure 4 Schematic illustration. In some embodiments, the potential advantage of designing a form that adapts to the anatomical region of the subacromial space is that it potentially avoids undesirable movement of the exemplary shoulder spacer 300 within that region after positioning. In some embodiments, the medial region / proximal end 306 of the device is configured to be positioned adjacent to the medial retracted stump of the torn rotator cuff on the glenoid rim. In some embodiments, the lateral region / distal end 304 of the device is configured to be positioned near the lateral stump of the rotator cuff attached to the humeral head and the inner layer of the deltoid muscle. In some embodiments, the anterior "wing" 310 is configured to be positioned within a pocket formed by the anterior shoulder joint capsule and the subscapularis muscle. In some embodiments, the posterior wing 308 is configured to be positioned within a pocket formed by the posterior shoulder joint capsule and the teres minor muscle. In some embodiments, the superior surface / upper surface 324 of the device is configured to face the attachment points of the acromion and deltoid muscle. In some embodiments, the inferior surface / lower surface 326 of the device is configured to face the humeral head.

[0118] In some embodiments, the shoulder spacer is configured to match the patient's specific anatomy; for example, the anterior and posterior wings, after implantation and in the deployed state, match the curvature / radius of curvature of the humeral head. In some embodiments, the device's anatomy is used to create a fixed side (superior / superior surface) with the acromion as the humeral head slides against the inferior / inferior surface within its range of motion. In some embodiments, portions of the projections (wings) are positioned on the humeral head itself; for example, portions of the projection facing the lateral / distal end 304 of the device that contact the humeral head match the curvature of the humeral head, while portions of the projection facing the medial / proximal end 306 of the device are held, for example, at their respective anatomical pockets, as described elsewhere herein.

[0119] Now for reference Figure 5A schematic diagram illustrating exemplary dimensions of an exemplary shoulder spacer 300 according to some embodiments of the present invention is shown. In some embodiments, the exemplary dimensions of the exemplary shoulder spacer 300 are as follows:

[0120] The body length is defined as the distance from the farthest point of the outer end 304 to the farthest point of the inner end 306, ranging from approximately 5 cm to approximately 7 cm (arrow 502), optionally from approximately 4 cm to approximately 8 cm, optionally from approximately 3 cm to approximately 12 cm, and any value in between. For example, lengths of 6 cm, 6.5 cm, and 7.5 cm.

[0121] The body width is defined as approximately 3cm to approximately 5cm (arrow 504), the distance between the rear side edge 312 and the front side edge 314 without a protruding area, optionally approximately 2cm to approximately 6cm, optionally approximately 2cm to approximately 8cm, and any value in between. For example, widths of 4cm, 4.5cm, and 6.5cm.

[0122] The wing length is defined as approximately 2 cm to approximately 4 cm (arrow 506), the distance between two locations where the protrusion extends from the rear side 312 or the front side 314, optionally approximately 3 cm to approximately 5 cm, optionally approximately 1 cm to approximately 6 cm, and any value in between. For example, wing lengths of 3 cm, 3.5 cm, and 4.5 cm.

[0123] The wing width (arrow 508) is defined as the distance from the furthest point of the front / rear side of the wing to the dashed line 316 / 318, ranging from approximately 2 cm to approximately 4 cm. Optionally, the wing width can range from approximately 3 cm to approximately 5 cm. Optionally, the wing width can range from approximately 1 cm to approximately 8 cm, and the wing length can be any value in between. Examples include wing widths of 3 cm, 3.5 cm, and 4.5 cm.

[0124] Defined as the distance between the two dashed lines 316 / 318, the spacing between the protrusions (wings) is approximately 1 cm to approximately 3 cm (arrow 510), optionally from approximately 0.5 cm to approximately 4 cm, optionally from approximately 0.3 cm to approximately 5 cm, and any value in between. For example, spacings of 2 cm, 2.5 cm, and 3.5 cm.

[0125] The total thickness is approximately 10 mm to approximately 12 mm, optionally approximately 8 mm to approximately 14 mm, optionally approximately 6 mm to approximately 16 mm, and any value in between. For example, thicknesses of 11 mm, 11.5 mm, and 12.5 mm.

[0126] In some embodiments, the width and / or thickness of the outer / distal end 304 of the device is greater than the width and / or thickness of the inner / proximal end 306 of the device.

[0127] In some embodiments, the width and / or thickness of the outer / distal end 304 of the device is shorter than the width and / or thickness of the inner / proximal end 306 of the device.

[0128] In some embodiments, the width and / or thickness of the outer / distal end 304 of the device is the same as the width and / or thickness of the inner / proximal end 306 of the device.

[0129] In some embodiments, the width and / or thickness of the rear wing 308 of the device is greater than the width and / or thickness of the front wing 310 of the device.

[0130] In some embodiments, the width and / or thickness of the rear wing 308 of the device is shorter than the width and / or thickness of the front wing 310 of the device.

[0131] In some embodiments, the width and / or thickness of the rear wing 308 of the device is the same as the width and / or thickness of the front wing 310 of the device.

[0132] Now for reference Figures 6a-6j A schematic diagram illustrating the exemplary geometry and curvature of an exemplary shoulder spacer according to some embodiments of the present invention is shown. Figures 6a-6j The use of Figure 3 The same parts are labeled in the attached drawings.

[0133] Figure 6a An exemplary shoulder spacer including a flat configuration is shown. In some embodiments, the device is prefabricated to have a flat configuration. This means that the device naturally achieves a flat configuration without external force.

[0134] Figure 6b An exemplary shoulder spacer including a convex configuration is shown. In some embodiments, the device is pre-fabricated to have a "heavily convex" convex configuration, for example, the device includes a radius of curvature of about 25 mm, optionally about 15 mm to about 20 mm, optionally about 10 mm to about 25 mm, optionally about 8 mm to about 35 mm. This means that the device naturally achieves a heavily convex convex configuration without external force.

[0135] Figure 6cAn exemplary shoulder spacer including a convex configuration is shown. In some embodiments, the device is pre-fabricated to have a "slightly convex" convex configuration, for example, the device includes a radius of curvature of about 50 mm, optionally about 35 mm to about 45 mm, optionally about 30 mm to about 55 mm, optionally about 25 mm to about 70 mm. This means that the device naturally achieves a slightly convex convex configuration without external force.

[0136] Figure 6d An exemplary shoulder spacer including a flat configuration is shown. In some embodiments, the device is pre-fabricated to have a flat configuration and a shorter body with shorter protrusions. This means that the device naturally achieves a flat configuration without external force. Figure 6e and 6f Similar to Figure 6b and 6c However, it has the following characteristics: Figure 6d The shoulder spacer shown.

[0137] Figure 6g An exemplary shoulder spacer including a convex configuration is shown. In some embodiments, the device is pre-fabricated to have a convex configuration and wider protrusions (with...). Figure 6a (Compared to -c). This means that the device naturally achieves a flat configuration without external force.

[0138] Figure 6h An exemplary shoulder spacer including a convex configuration is shown. In some embodiments, the device is prefabricated to have a convex configuration and two different protrusions that are opposite to and offset from each other.

[0139] Figure 6i An exemplary shoulder spacer is shown, wherein protrusion 310 is as described above, while another protrusion 308 is configured to enter the supraspinous fossa.

[0140] Figure 6j An exemplary shoulder spacer with a wide protrusion 308 and a narrow protrusion 310 is shown.

[0141] Exemplary use of more than one shoulder spacer

[0142] Now for reference Figure 7 The diagram illustrates the use of a double shoulder spacer according to some embodiments of the invention. In some embodiments, more than one device is used to fill the desired space within the shoulders. Figure 7The image shows two shoulder spacers 702 / 704, one on top of the other. In some embodiments, the first device is rolled up and installed arthroscopically, for example, through an inlet of about 1 cm in diameter. In some embodiments, the second device will be located above or below the first device without any connection between them. In some embodiments, the movement of each device within the subacromial space is restricted, but includes the flexibility to move relative to the other device during daily activities. In some embodiments, the length and width of the devices are similar to or the same as the size range described elsewhere herein, and the thickness may have a small minimum range of 1 mm to 10 mm. In some embodiments, optionally, each device will have a thickness of 4-6 mm, and the decision to use one, two, or three devices will be made by the surgeon based on the target space dimensions of the specific patient.

[0143] Exemplary uses of shoulder spacers besides RTC repair

[0144] In some implementations, as a supplement to (but not just a replacement for) RTC repair, other methods may be used, such as... Figure 3 The exemplary shoulder spacer shown Figure 7 The example shoulder spacer is shown as a thinner version. In some embodiments, a potential advantage of using the example shoulder spacer is that it can potentially provide protection for the repair during healing.

[0145] Exemplary mechanical characteristics of an exemplary shoulder spacer 300

[0146] In some embodiments, the device is configured to resist pressure generated under physiological load. In some embodiments, the shoulder spacer is made of a flexible material. In some embodiments, the shoulder spacer is made of a single homogeneous material. In some embodiments, the shoulder spacer is made of two or more materials. In some embodiments, one of these materials is used to coat 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 hydroxyalkanoic acids, polyorthoesters, polyphosphazenes, polyphosphates, polyanhydrides, and any copolymers and blends thereof; homopolymers and copolyesters made from lactic acid, glycolic acid, and caprolactone. Preferred polymers are safe polymers that have been used clinically and have demonstrated predictable biodegradability, namely PGS-poly(sepiacetyl sebacate), PGSU-poly(sepiacetyl sebacate)carbamate, PCL, PGA, PHB, Plastarch Material, PEEK, corn gluten, PDO, PLA, PLGA, polycaprolactone, polydiaxone, polylactide, poly(lactide-glycolic acid), poly(lactide-caprolactone), and polycaprolactone, or shape memory polymers (SMPs) made from multi-block copolymers of lactide and caprolactone that can elongate when heated and curl when cooled to body temperature, or any combination thereof. The properties of the polymer composition can be tailored to any requirement by blending various polymers or by mixing the polymers with hydrophobic or hydrophilic additives that modify the polymer properties. Such additives can be plasticizers to increase device flexibility, hydrophilic components such as polyethylene glycol, and minerals that increase hydrophilicity and act as pore-forming agents. The hydrophobic component can be triglycerides, fatty acids and esters, and other biodegradable polymers. Polymer structure and molecular weight play a crucial role in designing the desired properties of the polymer composition. Furthermore, optionally and / or alternatively, the device can be made from natural, biocompatible, and / or biodegradable materials such as collagen, agarose, polyethylene glycol (PEG), and / or methylcellulose. In some exemplary embodiments of the invention, the device is made from at least one non-biodegradable material such as polyethylene (PE), polyurethane (PU), silicone (Si), or dyneema. ® and / or Kevlar ®In some embodiments, the shoulder spacer is made of and / or coated with a material that prevents the accumulation of tissue (e.g., fibrotic tissue) on the shoulder spacer. A potential advantage of this is that it allows the shoulder spacer to remain "floating" in the implantation area, which allows for dynamic function of the shoulder spacer when needed. In some embodiments, the shoulder spacer is made of and / or coated with a material that promotes or partially promotes the accumulation of tissue (e.g., fibrotic tissue) on the shoulder spacer. A potential advantage of this is that it increases the natural anchorage of the device at the implantation site.

[0147] In some embodiments, the form / geometry of the device allows it to not generate focal peak pressure under the acromion and distributes pressure under the acromion similar to a natural state. In some embodiments, under maximum pressure, the compressed area will allow for a thickness reduction of up to 50%, for example, a reduction of 5-6 mm under load.

[0148] In some embodiments, the 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:

[0149] - An exemplary shoulder spacer 300 is configured to withstand a picking force of approximately 50 Newtons;

[0150] - An exemplary shoulder spacer 300 is configured to be compressed to 50% of its thickness under a maximum pressure of 1 MPa;

[0151] - An exemplary shoulder spacer 300 is configured to have an elastic modulus in the range of about 1 MPa to about 20 MPa;

[0152] - An exemplary shoulder spacer 300 is configured to distribute pressure between the contact surfaces of the shoulder spacer and the bone, so that the average pressure will be from about 100 kPa to about 200 kPa, and the peak pressure will be from about 600 kPa to about 1500 kPa.

[0153] Exemplary absorption quality of exemplary shoulder spacer 300

[0154] In some embodiments, the exemplary shoulder spacer 300 is made of a liquid-absorbing material, which causes the shoulder spacer 300 to increase in size due to liquid absorption. In some embodiments, the shoulder spacer is configured to increase in size at a ratio ranging from about 1:1.5 to about 1:5, optionally from about 1:1.1 to about 1:10. Or in other words, the shoulder spacer is configured to increase in size from about 50% to about 500% when exposed to liquid and / or liquid environments. In some embodiments, a potential advantage of using a device that increases in size after implantation is that it may potentially allow for the creation of small devices that are easy to arthroscopically implanted, while subsequently achieving the desired size to meet mechanical requirements. In some embodiments, the device increases in size irreversibly. In some embodiments, the exemplary shoulder spacer may increase in size irreversibly and degrade over time (see the explanation of degradation below). In some embodiments, exemplary materials for absorbing mass are hydrogels, such as polyacrylic acid with an average viscosity-average molecular weight (Mv) of 4,000,000, 3,000,000, 1,250,000, 450,000 or any combination thereof; or, for example, collagen-based absorbable materials; or, for example, any other suitable absorbable material.

[0155] Exemplary delivery method of exemplary shoulder spacer 300

[0156] In some embodiments, the device is inserted in its undeployed state through an arthroscopic inlet up to 12 mm in diameter, or through a small incision of 3-4 cm. In some embodiments, to allow for arthroscopic insertion, the exemplary shoulder spacer 300 is rolled into a cylindrical shape using, for example, vacuum packaging or any other similar technique, which allows insertion using a standard arthroscopic delivery system. In some embodiments, when using a small incision, the device is manually inserted by a surgeon through the incision. In some embodiments, once inserted, the device is released into its deployed state, thus naturally occupying the area in the shoulder.

[0157] In some implementations, the exemplary shoulder spacer 300 is delivered without the need for a dedicated delivery system.

[0158] Exemplary sponge-based shoulder spacer

[0159] In some embodiments, the exemplary shoulder spacer 300 is made of sponge and / or sponge-like material (hereinafter referred to as a sponge-based shoulder spacer). In some embodiments, the exemplary sponge-based shoulder spacer is manufactured to have a desired size in an unfolded state. In some embodiments, the exemplary sponge-based shoulder spacer is configured to be compressed so that the device is in an unfolded state. In some embodiments, the unfolded state includes a cylindrical shape. In some embodiments, the exemplary sponge-based shoulder spacer includes a diameter of about 10 mm to about 12 mm, optionally about 8 mm to about 14 mm, optionally about 6 mm to about 16 mm. In some embodiments, in the unfolded state, the exemplary sponge-based shoulder spacer maintains a thickness of about 5 mm under peak forces generated by the shoulder during the load-bearing range of motion. In some embodiments, the exemplary sponge-based shoulder spacer is manufactured using 3D printing technology.

[0160] An exemplary shoulder spacer with a reinforced housing

[0161] Now for reference Figure 8a -d, which shows an image of an exemplary shoulder spacer with an enhanced shell according to some embodiments of the present invention. Figure 8a A front view of an exemplary shoulder spacer with an enhanced housing is shown; Figure 8b A top view of the shoulder spacer with a reinforced outer shell is shown; Figure 8c A cross-sectional view of a shoulder spacer with a reinforced outer shell is shown (section lines are drawn by...). Figure 8b (The line 804 is depicted schematically in the middle); Figure 8d yes Figure 8c A close-up view of the marked area.

[0162] In some embodiments, an exemplary shoulder spacer with a reinforced shell includes an outer shell 802, multiple internal reinforcing structures, macropores, and / or micropores. In some embodiments, a "sponge-like" raw material is used as the filling material for the internal reinforcing structures, thereby creating a sponge-like structure (macropore) made of a sponge-like material with smaller pores (micropores) to produce a shoulder spacer with a reinforced shell.

[0163] Now for reference Figure 8e-g illustrates an exemplary internal organization of an exemplary shoulder spacer with a reinforced shell according to some embodiments of the present invention. In some embodiments, the shoulder spacer with a reinforced shell includes an outer shell 802. In some embodiments, within the outer shell 802, there are a plurality of internal reinforcing structures 806 extending within the outer shell 802. In some embodiments, large openings are created between the internal reinforcing structures 806 in spaces 808 where there are no internal reinforcing structures 806. In some embodiments, the entire shoulder spacer with a reinforced shell is made of a material including micropores 810.

[0164] In some implementations, the internal reinforcement structure 806 is generated with a dedicated geometry. For example, in Figure 8e In the middle, the internal reinforcing structure 806 extends at an angle "α", while Figure 8f In the middle, the internal reinforcing structure 806 extends at a 90-degree angle. Figure 8g In the middle, the internal reinforcement structure 806 has a "V" shaped structure, which extends at the bottom part at an angle "α", changes direction at the middle space at an angle "θ", and reaches the top part at an angle "ρ".

[0165] Figure 8h -i and 8j-k illustrate two different exemplary embodiments of the internal reinforcement structure 806 according to some embodiments of the present invention. Figure 8h -i indicates the tubular internal reinforcement structure 806, while Figure 8j -k indicates the flat internal reinforcement structure 806.

[0166] In some embodiments, the exemplary shoulder spacer with a reinforced housing is optionally designed to have more structural internal reinforcement in areas where high pressure is expected to be applied to the shoulder spacer. In some embodiments, the size, number, and shape of the internal reinforcement, macropores, and micropores are based on the design criteria of the final device.

[0167] Exemplary general scope of internal reinforcement structures and micropores / macropores

[0168]

[0169] An exemplary reinforced housing with a hollow external structure

[0170] Now refer to Figure 9a -c, which illustrates a schematic diagram of an exemplary reinforced housing having a hollow external structure according to some embodiments of the present invention. In some embodiments, the exemplary reinforced housing is as follows: Figure 8aAs shown in -k, a plurality of orifices 902 are added, which are distributed across the entire length of the device body, or at least partially across the length of the device body. In some embodiments, an exemplary method for producing a reinforced housing with a hollow external structure is, for example, employing... Figure 8a The device is shown in -k, and the hole is formed from the outside in. In some embodiments, a potential advantage of creating the orifice is that it produces a flexible structure that will meet design requirements (load-bearing capacity, volume, fatigue, etc.) and is also easier to roll into a tube, for example, about 10 mm, which would allow the surgeon to install the device arthroscopically. In some embodiments, the orifice 902 can be created by cutting, drilling, etc., or it can be part of a mold insert in injection molding or similar methods. In some embodiments, the positioning of the orifice 902 is not random and can be as follows: Figure 9b The "through" opening shown extends from the top surface to the bottom surface, or as... Figure 9c The diagram shows "semi-penetrating" openings from each surface. In some embodiments, optionally, the large opening is positioned opposite to the large opening on the other side, allowing less material to affect the thickness of the device when rolled into an unrolled state for arthroscopic mounting. In some embodiments, the positioning of the large opening on the upper side is "reverse" to the positioning of the large opening on the lower side (e.g., as shown in the diagram). Figure 9c (As shown).

[0171] Exemplary biodegradable shoulder spacer

[0172] In some implementations, the exemplary shoulder spacer may optionally be made of a biodegradable material (the device may be made of either biodegradable or non-biodegradable material).

[0173] In some embodiments, when the exemplary shoulder spacer is made of a biodegradable material, 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 sudden loss of support, a situation that commonly occurs in other types of shoulder spacers such as air-cushioned shoulder spacers, where, in the event of airbag failure, the user suddenly loses the support provided by the device, which can lead to joint injury, pain, and potentially hinder optimal joint recovery.

[0174] In some embodiments, when the exemplary shoulder spacer is made of a biodegradable material, the exemplary shoulder spacer is designed to function for a period of approximately 6 to approximately 12 months, while maintaining a distance of at least 11 mm between the acromion and the humeral head, preferably between approximately 7 mm and approximately 13 mm, for example, between approximately 10 mm and approximately 12 mm, optionally between approximately 11 mm and approximately 15 mm, or optionally between approximately 11 mm and approximately 20 mm. In some embodiments, the shoulder spacer is configured to completely degrade after 12 months, optionally after a period of approximately 12 to approximately 18 months, or optionally after a period of approximately 12 to approximately 24 months.

[0175] Now for reference Figure 10a -f shows a schematic diagram of an exemplary structure of an exemplary shoulder spacer according to some embodiments of the present invention.

[0176] In some implementations, as described above, the exemplary shoulder spacer is made of a biodegradable material and is designed to degrade gradually and / or in a controlled manner.

[0177] In some implementations, the degradation rate is controlled by providing an exemplary shoulder spacer with a single body having a known degradation rate.

[0178] In some embodiments, the degradation rate is controlled by providing an exemplary shoulder spacer having one or more layers, each with a known degradation rate. In some embodiments, the degradation rate is influenced and / or pre-configured according to one or more of the following: material type, material composition, and material thickness. For example, when the degradation rate is set according to thickness, the thickness of each layer can vary, for example, from about 0.1 mm to about 2 mm, based on the desired degradation time. In some embodiments, a potential advantage of designing a shoulder spacer that incorporates a layer-based degradation mechanism is that it potentially allows for phased adaptation of shoulder muscles to changes in the volume of the shoulder spacer and potentially ensures that degradation occurs along the thickness direction of the shoulder spacer (rather than along the width or length direction).

[0179] In some embodiments, the degradation principle of the exemplary shoulder spacer involves degradation only along the height (or thickness) axis, maintaining a constant width and length of the device during degradation. In some embodiments, limiting degradation to the height axis has the potential advantage of allowing the device to remain anchored in place during degradation and potentially preventing unwanted movement of the device in the shoulder region, even in advanced degradation phases.

[0180] In some implementations, degradation is designed to occur primarily from one side of the shoulder spacer, for example, Figure 10a -c is shown. Figure 10a A cross-sectional view of a portion of an exemplary shoulder spacer is shown at the start of the process. The top layer 1002 is configured to either not degrade at all or be the last to degrade after a predetermined period of time (e.g., after 12 months). The lower layers 1004, 1006, 1008, and 1010 will degrade one after another. For example, as... Figure 10b As shown, after a predetermined time period, the lower layer 1004 will degrade, exposing the next layer, namely layer 1006. Then, for example, as... Figure 10c As shown, after a predetermined time period, layer 1006 will degrade, exposing the next layer, namely layer 1008. In some embodiments, the degradation process continues until all layers are degraded, or until the top layer 1002 is reached (when the top layer is configured not to degrade).

[0181] In some implementations, degradation is designed to occur from both sides of the shoulder spacer, for example, as Figure 10d -f is shown. Figure 10d A cross-sectional view of a portion of an exemplary shoulder spacer is shown at the start of the process. The shoulder spacer includes a top layer and a bottom layer 1012, each followed by a layer 1014, then a layer 1016, and so on, towards the center of the shoulder spacer, until a central layer 1018 is reached. This central layer 1018 may optionally be biodegradable or non-biodegradable. The top and bottom layers 1012 degrade first, for example, as... Figure 10e As shown, layer 1014 is exposed. Then, for example, as... Figure 10f As shown, after a predetermined period of time, layer 1014 will degrade, exposing the next layer, namely layer 1016. In some embodiments, the degradation process continues until all layers have degraded, or until the central layer 1018, which is configured to be non-degradable, is reached.

[0182] Exemplary degradation rate

[0183] In some implementations, the degradation rate is predetermined based on the type and / or composition and / or thickness of the material layer used.

[0184] The table below shows exemplary degradation rates. It should be understood that the table is merely an example. Different degradation rates are also within the scope of this invention, and these examples are provided to enable those skilled in the art to understand the invention.

[0185]

[0186]

[0187] In some embodiments, the degradation of the shoulder spacer involves a reduction in thickness, rather than isotropic degradation. In some embodiments, the potential advantage of doing so is that the device degrades while maintaining the natural anchoring achieved by the geometry of the device.

[0188] Exemplary non-biodegradable shoulder spacer

[0189] In some embodiments, when the exemplary shoulder spacer is made of a non-biodegradable material, the exemplary shoulder spacer is designed to promote cell proliferation within the shoulder spacer after implantation, thereby allowing the generation of a viscoelastic volume within the subacromial space. In some embodiments, when the exemplary shoulder spacer is made of a non-biodegradable material, the exemplary shoulder spacer includes a pore-based scaffold configured as interconnecting channels with a diameter of about 150 μm to about 250 μm, optionally about 200 μm to about 400 μm, optionally about 100 μm to about 600 μm, for example, about 200 μm, 220 μm, 270 μm. In some embodiments, optionally, the scaffold includes one or more of growth factors, drugs, or similar agents for accelerating cell growth within the structure.

[0190] Exemplary in-situ infillable shoulder spacer

[0191] For reference Figure 11 An exemplary padded shoulder spacer 1100 according to some embodiments of the present invention is shown. In some embodiments, the exemplary shoulder spacer 1100 includes a padded body (hereinafter referred to as the padded shoulder spacer 1100). In some embodiments, exemplary forms of the padded body are, for example, as shown in the figure below. Figure 3 , 6aAs shown in -j and 8a-k. In some embodiments, the exemplary fillable shoulder spacer 1100 includes an opening 1102 configured to allow material to be inserted into or extracted from the body of the fillable shoulder spacer 1100. In some embodiments, the opening may be located anywhere on the surface of the fillable shoulder spacer 1100. In some embodiments, similar to what has been disclosed above, the exemplary fillable shoulder spacer 1100 includes an unexpanded state and an expanded state. Furthermore, in some embodiments, the exemplary fillable shoulder spacer 1100 includes an empty state and a filled state. In some embodiments, the exemplary fillable shoulder spacer 1100 is prepared by placing it in an empty, unexpanded state. In some embodiments, in this state, the exemplary fillable shoulder spacer 1100 is packaged and inserted into the shoulder as previously disclosed. In some embodiments, the exemplary fillable shoulder spacer 1100 then becomes an empty, expanded state within the shoulder. In some embodiments, the exemplary inflatable shoulder spacer 1100 is then in a filled, unfolded state within the shoulder by inserting material into the body via opening 1102. In some embodiments, the exemplary inflatable shoulder spacer 1100 changes directly from an empty, unfurled state to a filled, unfolded state by inserting material into the body via opening 1102, without performing a separate, dedicated step of unfolding the body. In some embodiments, the exemplary inflatable shoulder spacer 1100 is filled with one or more of the following: foam, PU foam, sponge-based foam, hydrogel, and any combination thereof.

[0192] In some implementations, the material used to fill the exemplary infillable shoulder spacer is configured to allow a transition from a never-expanded state to an expanded state, due to the sponge-based properties of the inserted material and / or due to the material's exposure to the environment, such as hydrogel.

[0193] Exemplary vacuum features for arthroscopic mounting

[0194] In some embodiments, an exemplary method for achieving an undeployed state that can be installed through an arthroscopic inlet of approximately 10 mm in diameter is to use an opening 1102 located in one of the device walls (proximal, lateral, anterior, or posterior), from which a delivery instrument is attached, and a vacuum pressure is applied, which allows the device to be effectively wound into the insertion cannula. In some embodiments, after the device is positioned in situ at the desired location, it is released, allowing air and / or fluid from the articular environment to re-enter the structure and achieve the desired volume.

[0195] Exemplary manufacturing method of an exemplary shoulder spacer

[0196] In some embodiments, exemplary manufacturing methods for the exemplary shoulder spacer 200 may be one or more of the following: casting, dip molding, 3D printing, injection molding, core-shell structure, and in-situ curing.

[0197] Exemplary method for implanting an exemplary shoulder spacer

[0198] For reference Figure 12 A flowchart illustrating an exemplary implantation method of an exemplary shoulder spacer according to some embodiments of the present invention is shown.

[0199] In some implementations, regardless of which of the above configurations is used, implanting an exemplary shoulder spacer includes one or more of the following actions:

[0200] 1. Provide a shoulder spacer 1202 in an undeployed configuration;

[0201] 2. Place the shoulder spacer in the middle of the shoulder 1204;

[0202] 3. The shoulder spacer is changed from a non-deployed configuration to a deployed configuration 706;

[0203] 4. Positioning portions of the shoulder spacer in their predetermined locations within the shoulder. In some embodiments, portions of the shoulder spacer are a medial region 306, a lateral region 304, an anterior wing 310, a posterior wing 308, a superior surface, and a inferior surface. In some embodiments, the predetermined locations are: for the medial region 306 of the device: adjacent to the medial retracted end of the torn rotator cuff located on the glenoid rim; for the lateral region 304 of the device: adjacent to the lateral retracted end of the rotator cuff attached to the humeral head and the inner layer of the deltoid muscle; for the anterior wing 310: within a pocket formed by the anterior shoulder joint capsule and the subscapularis muscle; for the posterior wing 308: within a pocket formed by the posterior shoulder joint capsule and the teres minor muscle; for the superior surface: facing the attachment point of the acromion and the deltoid muscle; for the inferior surface: facing the humeral head.

[0204] In some embodiments, when the device is absorbable, the method further includes exposing the shoulder spacer to a liquid, thereby allowing the body of the shoulder spacer to absorb the liquid.

[0205] In some embodiments, when the device includes a hollow body and includes an opening, the method further includes injecting liquid into the hollow body through the opening to perform a transition from the undeployed configuration to the deployed configuration.

[0206] As used in this article, the term “about” in relation to quantity or value means “within ±20% of”.

[0207] The terms “including,” “contains,” “comprising,” “with,” “having,” “possessing,” and their variations mean “including but not limited to.”

[0208] The term "including" means "including and limited to".

[0209] The term "consistent with / made up of" means that a composition, method, or structure may include additional ingredients, steps, and / or portions, provided that the additional ingredients, steps, and / or portions do not materially alter the essential and novel features of the claimed composition, method, or structure.

[0210] As used herein, the singular forms “a,” “an,” and “the / said” include the plural unless the context clearly indicates otherwise. For example, the terms “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof.

[0211] Throughout this application, embodiments of the invention can be presented in the form of a range. It should be understood that the range format is for convenience and brevity only and should not be construed as an immutable limitation on the scope of the invention. Therefore, the range description should be considered as having specifically disclosed all possible subranges and individual numerical values ​​within that range. For example, a range such as 1 to 6 should be considered as having specifically disclosed subranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., and individual numbers within that range, such as 1, 2, 3, 4, 5, and 6. This applies to any range width.

[0212] Whenever a range of numbers is indicated herein (e.g., “10–15”, “10 to 15”, or any pair of numbers connected by such another range indication), it is intended to include any number (fraction or integer) within the indicated range boundaries, including the range boundaries, unless the context explicitly states otherwise. The phrases “range between the first and second indicators” and “range from the first indicator to / to the second indicator” (or another such range indication term) are used interchangeably herein and mean to include the first and second indicators and all fractions and integers in between.

[0213] Unless otherwise stated, the numerical values ​​used herein and any ranges of numerical values ​​based thereon are approximations within the accuracy of reasonable measurement and rounding errors as understood by those skilled in the art.

[0214] As used herein, the term “method” refers to the manner, means, techniques and procedures used to accomplish a given task, including but not limited to those manner, means, techniques and procedures known to practitioners in the fields of chemistry, pharmacology, biology, biochemistry and medicine, or readily developed from known manner, means, techniques and procedures.

[0215] As used in this article, the term “treatment” includes eliminating, substantially inhibiting, slowing or reversing the progression of a disease, substantially improving the clinical or aesthetic symptoms of a disease, or substantially preventing the occurrence of the clinical or aesthetic symptoms of a disease.

[0216] It should be understood that, for clarity, certain features of the invention described in the context of individual embodiments may also be provided in combination in a single embodiment. Conversely, for brevity, various features of the invention described in the context of a single embodiment may also be provided individually, or in any suitable sub-combination, or appropriately provided in any other described embodiment of the invention. Certain features described in the context of various embodiments should not be considered essential features of those embodiments unless the embodiment would not function without these elements.

[0217] As described above and as claimed in the following claims section, various embodiments and aspects of the invention find experimental support in the following embodiments.

[0218] Example

[0219] The following embodiments, together with the foregoing description, illustrate some embodiments of the invention in a non-limiting manner.

[0220] Exemplary main user inputs and design inputs:

[0221]

[0222]

[0223]

[0224]

[0225]

[0226] Patient-specific – The device can be designed as a product for a specific patient and will include one or more of the following steps:

[0227] 1. Preoperative MRI scan (RCT standard shoulder protocol);

[0228] 2. MRI analysis based on morphology and size;

[0229] 3. Analysis of other patient parameters: gender, age, weight, activity level, and relevant medical history;

[0230] 4. Overall analysis and calculations to design the optimal device for a specific patient based on (all or some) of the following: size, shape, thickness, overall stiffness, joint surface roughness, biodegradability or permanence, functional time (if relevant), degradation time (if relevant), and surgical plan.

[0231] Exemplary manufacturing method:

[0232] Use a soluble mold:

[0233] A soluble core with a negative shape and internal reinforcement, plus an external permanent mold for molding the outer surface. Process:

[0234] Step I - Injecting the polymer into the mold. The polymer can be melted by pressure injection or can remain unmelted as a viscous fluid. It can be a biodegradable polymer or a permanently non-biodegradable polymer, and it can be spongy or dense.

[0235] Step II - After the injected material has cured, water or other fluids will enter the core volume in such a way that the core soluble structure will be dissolved and washed away.

[0236] Step III - Release the injected polymer from the permanent mold.

[0237] Although the invention has been described in conjunction with specific embodiments thereof, it will be apparent to those skilled in the art that many substitutions, modifications, and variations will be readily apparent. Therefore, the invention is intended to encompass all such substitutions, modifications, and variations falling within the spirit and broad scope of the appended claims.

[0238] The applicant intends that all publications, patents, and patent applications mentioned in this specification are incorporated herein by reference in their entirety, and when each individual publication, patent, or patent application is mentioned herein by reference in its entirety, it is as if each individual publication, patent, or patent application were specifically and individually cited in the reference. Furthermore, any reference or designation of any reference in this application should not be construed as an admission that such reference is prior art to the invention. The section headings used should not be construed as necessary limitations. Additionally, any priority documents of this application are incorporated herein by reference in their entirety.

Claims

1. A shoulder spacer comprising: a. A slender planar body extending along a longitudinal axis between the proximal and distal ends; b. At least two protrusions, each extending in a width direction perpendicular to the longitudinal axis, the at least two protrusions being located between the proximal end and the distal end.

2. The shoulder spacer according to claim 1, wherein, The at least two protrusions are positioned relative to each other on different sides of the body.

3. The shoulder spacer according to claim 1, wherein, A first portion of the body extends proximally beyond the protrusion toward the proximal end, and a second portion of the body extends distally beyond the protrusion toward the distal end.

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

5. The shoulder spacer according to claim 1, wherein, The main body is cross-shaped.

6. The shoulder spacer according to claim 1, wherein, The main body is a solid structure with a topological genus of zero.

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

8. The shoulder spacer according to claim 7, wherein, The main body includes a plurality of openings extending from the upper surface to the lower surface.

9. The shoulder spacer according to claim 7, wherein, The main body includes a plurality of upper openings extending from the upper surface toward the lower surface portion and a plurality of lower openings extending from the lower surface toward the upper surface portion.

10. The shoulder spacer according to claim 9, wherein, The positions of the upper orifice and the lower orifice are staggered.

11. The shoulder spacer according to claim 1, wherein, The main body is non-inflatable.

12. The shoulder spacer according to claim 1, wherein, The main body is flexible.

13. The shoulder spacer according to claim 1, wherein, The main body has a width of 1cm to 12cm.

14. The shoulder spacer according to claim 1, wherein, The main body has a thickness of 6 mm to 16 mm.

15. The shoulder spacer according to claim 1, wherein, The main body has a length of up to 12cm.

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

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

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

19. The shoulder spacer according to claim 1, wherein, The surface of the main body is smooth.

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

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

22. The shoulder spacer according to claim 1, wherein, The body is curved such that the protrusions face each other.

23. The shoulder spacer according to claim 1, wherein, The protrusion has a length of about 1 cm to about 6 cm, measured from the side of the body.

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

25. The shoulder spacer according to claim 24, wherein, In the unfolded configuration, the body has a size and shape configured to occupy a predetermined space and position within the shoulder and between at least two bones.

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

27. The shoulder spacer according to claim 1, wherein, The distal end of the body is configured to be positioned near the lateral remnant of the rotator cuff, which is attached to the humeral head and the inner layer of the deltoid muscle.

28. The shoulder spacer according to claim 1, wherein, One of the at least two protrusions is configured to be positioned within a pouch formed by the anterior shoulder joint capsule and the subscapularis muscle.

29. The shoulder spacer according to claim 1, wherein, One of the at least two protrusions is configured to be positioned within a pouch formed by the posterior shoulder joint capsule and the teres minor muscle.

30. The shoulder spacer according to claim 7, wherein, The upper surface is configured to face the attachment points of the acromion and deltoid muscle.

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

32. The shoulder spacer according to claim 1, wherein, The main body comprises multiple layers.

33. The shoulder spacer according to claim 32, wherein, Each of the plurality of layers is configured to be degradable.

34. The shoulder spacer according to claim 33, wherein, The degradation is carried out over a predetermined time period determined by the material of each of the plurality of layers.

35. The shoulder spacer according to claim 24, wherein, The body is made of an absorbent material; wherein the transition from the undeployed configuration to the deployed configuration is characterized by the body absorbing liquid.

36. The shoulder spacer according to claim 24, wherein, The body is a hollow body; wherein the hollow body includes an opening configured to allow liquid and / or air to enter the body in order to perform a transition from the undeployed configuration to the deployed configuration.

37. The shoulder spacer according to claim 24, wherein, The main body is a hollow body; wherein the hollow body includes an opening configured to allow air to be extracted from the body in order to perform a transition from the deployed configuration to the undeployed configuration.

38. The shoulder spacer according to claim 1, wherein, The main body includes an outer shell, multiple internal reinforcement structures, and multiple large holes located between the multiple internal reinforcement structures.

39. The shoulder spacer according to claim 1, wherein, The body is made of a material including micropores.

40. The shoulder spacer according to claim 38, wherein, The plurality of internal reinforcement structures are positioned to provide structural reinforcement to locations on the outer casing where a higher expected pressure level is desired.

41. A method for implanting a shoulder spacer in a human shoulder, the method comprising: a. Providing a shoulder spacer according to claim 1 in an undeployed configuration, the shoulder spacer comprising a body having a proximal end, a distal end, at least two protrusions, an upper surface, and a lower surface; b. Place the shoulder spacer in the shoulder; c. Change the shoulder spacer from the undeployed configuration to the deployed configuration; Changing the shoulder spacer to the unfolded configuration includes positioning the proximal end, the distal end, the at least two protrusions, the upper surface, and the lower surface at predetermined positions within the shoulder.

42. The method according to claim 41, wherein, The predetermined position of the proximal end of the body is adjacent to the medial retraction stump of the torn rotator cuff, located on the glenoid rim.

43. The method according to claim 41, wherein, The predetermined position at the distal end of the body is adjacent to the attachment of the rotator cuff to the lateral remnant of the humeral head and the inner layer of the deltoid muscle.

44. The method according to claim 41, wherein, The predetermined position of one of the at least two protrusions is within a pouch formed by the anterior shoulder joint capsule and the subscapularis muscle.

45. The method according to claim 41, wherein, The predetermined position of one of the at least two protrusions is within a pouch formed by the posterior shoulder joint capsule and the teres minor muscle.

46. ​​The method according to claim 41, wherein, The predetermined position on the upper surface faces the attachment point of the acromion and deltoid muscle.

47. The method according to claim 41, wherein, The predetermined position of the lower surface faces the humeral head.

48. The method according to claim 41, wherein, Changing the shoulder spacer from its undeployed configuration to its deployed configuration involves exposing the shoulder spacer to a liquid, thereby allowing the body of the shoulder spacer to absorb the liquid.

49. The method according to claim 41, wherein, Changing the shoulder spacer from its undeployed configuration to its deployed configuration includes injecting liquid into at least one cavity in the shoulder spacer.

50. The method of claim 41, further comprising converting the shoulder spacer into an undeployed configuration by extracting air from the body.

51. The method according to claim 50, wherein, Changing the shoulder spacer to an unfurled configuration involves rolling up the main body.

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