CONSTRAINED SHOULDER AND HIP ARTHROPLASTY

Abstract

The present invention provides systems, devices, and methods for using two or more flexible bands to constrain shoulder and/or hip replacement components to reduce dislocation and/or instability (e.g., constrain the glenosphere against a glenosphere recess, or constrain a femoral head against an acetabular component). In certain embodiments, one end of the flexible bands are attached to, or are held by, a first ring (e.g., expandable ring, such as a snap ring) that is configured to be operably connected (e.g., via a humeral baseplate) to a humeral stem, while another end of the flexible bands are attached to, or are held by, a second ring (e.g., flat ring, washer, annular, hoop, or orbital) that is configured to be operably connected (e.g., via a scapular baseplate) to a scapular bone. In some embodiments, an outer sleeve (e.g., cylindrical silicone sleeve) is employed that is sized to generally enclose the flexible bands, the glenosphere, and glenosphere recess, or conversely, for the hip joint, the femoral head and acetabular component liner.

Claims

1. A system comprising: a) a scapular baseplate comprising: i) a scapular bone connecting component, and ii) a glenosphere base connecting component; b) a humeral baseplate comprising: i) a humeral bone, and/or humeral stem, connecting component, ii) a glenosphere recess, and iii) a first ring connecting component, c) a glenosphere comprising: i) a top surface that articulates with said glenosphere recess, and ii) a bottom surface that attaches to said glenosphere connecting component of said scapular baseplate; d) a retainer assembly comprising: i) a first ring that attaches to said first ring connecting component of said humeral baseplate, ii) a second ring comprising a scapular baseplate connecting component, iii) a first flexible band: A) attached to, or configured to be attached to or held by, said second ring, and B) attached to, or configured to be attached to or held by, said first ring, iv) a second flexible band: A) attached to, or configured to be attached to or held by, said second ring, and B) attached to, or configured to be attached to or held by, said first ring, wherein said retainer assembly aids in constraining said system from dislocation and/or instability when said system is installed in a subject's shoulder joint.

2. The system of claim 1, wherein said first ring further comprises: A) a first flexible band attachment or holder site, and B) a second flexible band attachment or holder site.

3. The system of claim 2, wherein said first and second flexible band attachment or holder sites are notches or protrusions in said first ring.

4. The system of claim 1, wherein said second ring further comprises: A) a first flexible band holder or attachment site, and B) a second flexible band holder or attachment site.

5. The system of claim 4, wherein said first and second flexible band holder or attachment sites are notches or protrusions in said second ring.

6. The system of claim 1, wherein said retainer assembly further comprises: v) a third flexible band: A) attached to, or configured to be attached to or held by, said second ring, and B) attached to, or configured to be attached to or held by, said first ring.

7. The system of claim 6, wherein said second ring further comprises: A) a first flexible band attachment or holder site, B) a second flexible band attachment or holder site, and C) a third flexible band attachment or holder site.

8. The system of claim 6, wherein said first ring further comprises: A) first flexible band holder or attachment site, a B) second flexible band holder or attachment site, and a C) third flexible band holder or attachment site.

9. The system of claim 6, wherein said first flexible band would be in an anterior position when said system is installed in said subject's shoulder area, wherein said second flexible band would in a posterior position when installed in said subject's shoulder area, and wherein said third flexible band would be in a superior position when installed in said subject's shoulder area.

10. The system of claim 1, wherein said retainer assembly further comprises a retainer assembly outer sleeve that extends from said first ring to said second ring covering one or both sides of said first and second flexible bands.

11. The system of claim 10, wherein said retainer assembly outer sleeve surrounds said glenosphere and glenosphere recess when installed in said subject's shoulder area.

12. The system of claim 10, wherein said retainer assembly outer sleeve comprises a biocompatible flexible material.

13. The system of claim 11, wherein said biocompatible flexible material comprises silicone.

14. The system of claim 10, wherein retainer assembly outer sleeve comprises: i) a generally cylindrical outer wall, ii) a lateral split in said cylindrical wall, and iii) an aperture for said dowel pin of said scapular bone connecting component.

15. The system of claim 1, wherein said scapular base plate comprises titanium.

16. The system of claim 1, wherein said scapular bone connecting component comprises at least two or three apertures each sized for a bone screw.

17. The system of claim 16, further comprising two or three of said bone screws.

18. The system of claim 1, wherein said scapular baseplate has a diameter between 25 and 31 mm.

19. The system of claim 1, wherein said scapular baseplate further comprises: iii) a connecting component configured to connect to said scapular baseplate connecting component of said second ring.

20. The system of claim 19, wherein said connecting component, when connected to said scapular baseplate connecting component, prevents said second ring from rotating when said system is installed in said subject's shoulder area and said humerus is rotated relative to said scapula.

Description

DESCRIPTION OF THE FIGURES

[0024] The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawings will be provided by the Office upon request and payment of the necessary fee.

[0025] FIG. 1 shows an exemplary embodiment of the shoulder joint replacement system (50) herein and how the components are connected in a subject's shoulder. The right shoulder is shown.

[0026] FIGS. 2A and 2B depict back and front views of an exemplary embodiment of a fully assembled shoulder joint replacement system (50). The right shoulder is shown.

[0027] FIG. 3A depicts the front of an exemplary scapular baseplate (1).

[0028] FIG. 3B shows the bottom of the exemplary scapular baseplate (1).

[0029] FIG. 4 depicts the assembly of an exemplary scapular baseplate (1), central screw (2), and side screws (3) onto the native scapula.

[0030] FIGS. 5A and 5B depict an exemplary glenosphere. FIG. 5A depicts the top of an exemplary glenosphere (4), while FIG. 5B depicts the bottom.

[0031] FIG. 6 depicts an exemplary second ring (5) (e.g., as a washer), with a hole (80).

[0032] FIG. 7 depicts an exemplary first ring (6) (e.g., as a snap ring).

[0033] FIGS. 8A-8C show an exemplary flexible band. FIGS. 8A and 8B depict an exemplary flexible band (7), shown as an anterior Y-shaped band. FIG. 8C shows how the flexible band could be folded to create loops.

[0034] FIGS. 9A and 9B shows an exemplary flexible band (8), shown as a posterior band.

[0035] FIG. 9C shows how the flexible band could be folded at the ends to create loops (e.g., which are fixed with adhesive, ultrasonic welding, or heat staking).

[0036] FIGS. 10A and 10B show a superior band. FIG. 10A depicts an exemplary flexible band (9), shown as a superior band. FIG. 10B shows how the flexible band could be folded at the ends to create loops.

[0037] FIG. 11 shows an exemplary band assembly (13).

[0038] FIG. 12 shows an exemplary retainer assembly (14) for shoulder arthroplasty.

[0039] FIGS. 13A-D shows various views of an exemplary retainer assembly (14) employing three flexible straps.

[0040] FIG. 14 shows an exemplary humeral adapter tray (10).

[0041] FIG. 15 shows an exemplary humeral liner (11).

[0042] FIG. 16A shows the assembly of the exemplary adapter tray (10) and exemplary humeral liner (11) onto a humeral stem using a screw (12).

[0043] FIG. 16B shows the components assembled on the humerus bone.

[0044] FIG. 17 shows an exemplary retainer assembly (14) for hip joint arthroplasty.

[0045] FIGS. 18A and 18B show a retainer assembly. FIG. 18A shows a first view of a retainer assembly (14) employing two flexible straps (7 and 9). FIG. 18B is a second view of a retainer assembly (14) employing two flexible straps (7 and 9).

DETAILED DESCRIPTION

[0046] The present invention provides systems, devices, and methods for using two or more flexible bands to constrain shoulder and/or hip replacement components to reduce dislocation and/or instability (e.g., constrain the glenosphere against a glenosphere recess, or constrain a femoral head against an acetabular component). In certain embodiments, one end of the flexible bands are attached to, or are held by, a first ring (e.g., expandable ring, such as a snap ring) that is configured to be operably connected (e.g., via a humeral baseplate) to a humeral stem, while another end of the flexible bands are attached to, or are held by, a second ring (e.g., flat ring, washer, annular, hoop, or orbital) that is configured to be operably connected (e.g., via a scapular baseplate) to a scapular bone. In some embodiments, an outer sleeve (e.g., cylindrical silicone sleeve) is employed that is sized to generally enclose the flexible bands, the glenosphere, and glenosphere recess, or conversely, for the hip joint, the femoral head and acetabular component liner.

[0047] FIG. 1 shows an exemplary embodiment of the shoulder joint replacement system (50) herein and how the components are connected in a subject's shoulder. The scapular baseplate (1) is implanted with screws, followed by the retainer assembly (14). The glenosphere (4) is then threaded onto the scapular baseplate, thereby securing the retainer assembly on the scapular side. The humeral baseplate (34) (e.g., constructed with parts 10-12) is mated with the glenosphere after opening the first ring of the retainer assembly (6), for example with snap ring pliers. The right shoulder is shown.

[0048] FIGS. 2A and 2B depict back and front views of an exemplary embodiment of a fully assembled shoulder joint replacement system (50). The right shoulder is shown.

[0049] FIG. 3A depicts the front of an exemplary scapular baseplate (1) (e.g., 28 mm in diameter), which may be composed of a suitable Ti alloy. FIG. 3B shows the bottom of the exemplary scapular baseplate (1), which may be constructed of porous Ti (22), which stimulates bone in-growth. In general, the remaining surfaces are smooth. FIG. 3A shows a glenosphere base connecting component (21), which may be an 8 mm male threaded post situated in the center of the baseplate. The threaded post mates with the glenosphere (4), via attachment bottom hole (23), which may be corresponding female threads (see FIG. 5). The inner surface of the post (21) is threaded, and accepts a locking compression screw (2) with a 6.25 mm threaded head and 4 mm outer diameter shaft. There are two 6.3 mm diameter holes (55) in the baseplate, arranged 180 degrees relative to one another, which accept screws (3), such as 5 mm non-locking screw for fixation into the glenoid. A baseplate mating component (25) (e.g., 2.5 mm dowel pin) mates with the first ring (5), providing stability such that (5) cannot rotate relative to part 1.

[0050] FIG. 4 depicts the assembly of an exemplary scapular baseplate (1), central screw (2), and side screws (3) onto the native scapula. The right scapula is shown for illustrative purposes, and the articular cartilage has been reamed to bleeding subchondral bone to allow for bone ingrowth. Non-locking screws (3) are placed through the scapular baseplate (1) followed by a central locking compression screw (2). The baseplate (1) has a dowel pin (25) which is oriented toward the anterior portion of the scapula.

[0051] FIG. 5A depicts the top of an exemplary glenosphere (4), while FIG. 5B depicts the bottom, which includes an attachment bottom hole (23) that mates with the glenosphere connecting component (e.g., male threaded post (21)) of the scapular baseplate (1). The glenosphere has a hole on top (adjustment hole 24) where a tool can be inserted, such as a hex or Torx tool, to turn the glenosphere such that the attachment bottom hole (23) is tightened down onto the threaded post (21) of the scapular baseplate (1).

[0052] FIG. 6 depicts an exemplary second ring (5), which may be a washer as shown in this figure. The second ring may be constructed from 316L stainless steel, CoCr alloy, or other suitable material. Exemplary second ring (5) contains a 2.75 mm hole (80) that accepts the 2.5 mm dowel pin located on the scapular baseplate (1), which imparts rotational control of part 5 relative to part 1. In addition, three slots are located on the second ring (5) at the anterior, superior, and posterior positions as viewed on face. These accept the flexible bands (parts 7, 8, and 9). These slots secure the location of parts 7-9 in relation to part 5.

[0053] FIG. 7 depicts an exemplary first ring (6). The exemplary first ring is shown as a snap ring composed of nitinol. Four slots (26) are located at the anterior (7), superior (9), and posterior (8) positions as viewed on face. These accept the flexible bands. These slots secure the location of parts 7-9 in relation to part 6. In addition, the exemplary first ring (6) contains two holes which accept a snap ring pliers, allowing the surgeon to expand or open the first ring in order to deliver the humeral assembly into the retainer assembly to articulate with the scapular assembly (glenosphere) in vivo. Once the snap ring pliers are removed, the nitinol will bend back to the original circular shape. Suture will then be placed by the surgeon around the anterior flexible band and the surgeon would, in certain embodiments, thread this suture through the holes (60). Notably, this would not be necessary to the survivorship of the implant given the intrinsic material properties of the nitinol.

[0054] FIGS. 8A and 8B depict an exemplary flexible band (e.g., fabric band) (7), shown as an anterior Y-shaped band. FIG. 8C shows how the flexible band can be folded on itself at the ends to create loops. In certain embodiments, these bands are made of ultra-high molecular weight polyethylene (UHMWPE) (or similar material) fashioned into a tubular braid, which provides high tensile strength (e.g., load to failure: 75 kg) while allowing 15% elongation under applied load. The bands converge on one side, near part 5. They are attached to parts 5 and 6 (in corresponding slots) by doubling over on the fold lines (8C) and forming a loop (e.g., which are fixed with adhesive, ultrasonic welding, or heat staking) , to which an adhesive is applied. The band is thermally annealed to the necessary length. The open portion of the Y-shape allows the humeral assembly to be delivered into the first ring (and thereby, the retainer assembly), for example, once a snap ring pliers opens the nitinol snap ring.

[0055] In certain embodiments, the flexible bands described herein are composed of materials described in US20190301090 (herein incorporated by reference), ultra-high molecular weight polyethylene, or artificial tendon material from LARS, ATEX Technologies, or SURGICALMESH. In certain embodiments, the flexible bands are braided (e.g., tubular braid), woven, or knitted structure of the material. In some embodiments, the material is polyethylene, polypropylene or polyester (or similar fabric). As long as whatever is used is formed into a braid, knit, or weave. In particular embodiments, the flexible band material is capable of being thermally annealed (shrunk to a specific length yet retain its mechanical characteristics).

[0056] FIGS. 9A and 9B show an exemplary flexible band (8), shown as a posterior band. FIG. 9C shows how the flexible band could be folded on itself at the ends to create loops. The flexible band (8) is attached to parts 5 and 6 (e.g., in corresponding slots) by doubling over on the fold lines (FIG. 9C) and forming a loop (e.g., which is fixed with adhesive, ultrasonic welding, or heat staking) . The band is thermally annealed to the necessary length.

[0057] FIG. 10 depicts an exemplary flexible band (9), shown as a superior band. FIG. 10B shows how the flexible band could be folded on itself at the ends to create loops. In certain embodiments, the superior band would require about 5% elongation.

[0058] FIG. 11 shows an exemplary band assembly (13). This assembly includes three flexible bands (7, 8, and 9) extending between a second ring (5) and a first ring (6).

[0059] FIG. 12 shows an exemplary retainer assembly (14) for shoulder arthroplasty. This assembly is composed of an exemplary band assembly (13), and includes a retainer assembly outer sleeve (20) that surrounds the band assembly. The retainer outer sleeve contains a split region (70) that allows the sleeve to be opened up to a larger size to fit over the humeral assembly and capture it at its first ring recess (35). The retainer outer sleeve also includes an opening (71) that corresponding with the hole in the second ring (5).

[0060] FIGS. 13A-D shows various views of an exemplary retainer assembly (14) employing three flexible straps. FIG. 13A shows a side view of an exemplary retainer assembly (14). FIG. 13B shows detail “B” from FIG. 13A, showing the first ring end (33) of the flexible band (9). FIG. 13C shows a bottom view of the exemplary retainer assembly (14), including a hole (71) in the retainer assembly outer sleeve (20). FIG. 13D shows a cross section through A-A of FIG. 13C.

[0061] FIG. 14 shows and exemplary humeral adapter tray (10), which contains a recess (81) to accept a humeral liner (11). The adapter tray (10) has a peripheral recess (35) to accept the first ring (e.g., nitinol snap ring), and a central hole (80) to accept screw (12). This screw links the adapter tray (10) and humeral liner (11) to a threaded hole in a humeral stem.

[0062] FIG. 15 shows an exemplary humeral liner (11), which may be composed of UHMWPE, or similar material. It contains a 40 degree bevel on the bottom to mate with the humeral adapter tray (10), a glenosphere recess (36) on the top which articulates with the glenosphere (4), and a central hole (82) to accept a fastening screw (12). The radius of curvature of the glenosphere recess (36) generally matches that of the glenosphere (4), thereby allowing conforming articulation.

[0063] It is noted that the humeral adapter tray (10) and humeral liner (11) could be a single unitary component, making up the humeral baseplate (34). In particular embodiments, it is more advantageous to have separate components 10 and 11 to allow height adjustment in vivo to match patient anatomy. In other embodiments, (e.g., as in hip arthroplasty), a single unitary component may be employed.

[0064] FIG. 16A shows the assembly of the exemplary humeral adapter tray (10) and exemplary humeral liner (11) onto a humeral stem using a screw (12). FIG. 16B shows the components assembled on the humerus bone.

[0065] FIG. 17 shows an exemplary retainer assembly (14) for hip joint arthroplasty. FIG. 17 depicts how the fully constrained retainer assembly could be employed for total hip replacement. “A” is the acetabular component, “B” is the acetabular liner, “C” is the femoral head, “D” is the trunnion of the femoral stem, and “E” is a hole in A (threaded) and B (non-threaded) which could accept a fastening screw (not shown), thereby capturing the second ring (5) and preventing dissociation of parts A and B in vivo. The hip retainer assembly (14) is composed of the second ring (5) and first ring (6) with bands 7, 8, and 9 stretching therebetween. The retainer assembly outer sleeve (20) is partially shown and can be a liquid silicone rubber over-mold, which is pliable.

[0066] FIG. 18A shows a first view of a retainer assembly (14) employing two flexible bands (7 and 9). FIG. 18B is a second view of a retainer assembly (14) employing two flexible bands (7 and 9).

[0067] The exemplary steps for implanting the components of the systems herein (using exemplary components) into a subject's shoulder are as follows. The shoulder is exposed via a standard deltopectoral approach. A guidewire is placed in the correct position on the glenoid, ensuring neutral version and inferior tilt. Reaming is performed until the appearance of bleeding subchondral bone. The scapular baseplate (part 1) is inserted over the guidewire. Two peripheral non-locking screws (part 3) are then placed through the superior and inferior holes in the baseplate. The guidewire is withdrawn. A central locking compression screw (part 2) is then inserted. The retainer assembly (part 14) is then placed onto the baseplate such that the second ring (part 5) is aligned with the baseplate dowel pin. The glenosphere (part 4) is then secured onto the central threaded post of the baseplate with an appropriate driver.

[0068] Attention is then turned to the humerus. The canal is prepared with reamer and broach. The humeral stem is inserted with either press-fit or cemented technique per surgeon discretion. The humeral adapter tray and liner (parts 10 and 11) are then placed onto the humeral stem and secured with a fastening screw (part 12). A snap ring pliers is applied to the first ring (part 6) of the retainer assembly to open the ring. The humeral assembly is delivered en bloc into the retainer assembly and the shoulder joint is reduced (e.g., glenosphere mated to the glenosphere recess). The snap ring pliers are withdrawn and the nitinol ring closes around the humeral adapter tray, securing itself within the peripheral recess. The surgeon then places running or interrupted sutures around the anterior Y-shaped band and into the retainer assembly to close down the anterior split. The nitinol ring is closed with suture passed through the snap ring holes at the surgeon's discretion.

[0069] All publications and patents mentioned in the present application are herein incorporated by reference. Various modification and variation of the described methods and compositions of the invention will be apparent to those skilled in the art without departing from the scope and spirit of the invention. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention that are obvious to those skilled in the relevant fields are intended to be within the scope of the following claims.