REVERSE SHOULDER PROSTHESIS AND RELATED METHODS

Abstract

Disclosed is a prosthetic joint assembly for joining a humerus bone to a scapula bone, comprising a humeral component adapted for engagement with said humerus bone and a concave dish; a scapular component adapted for engagement with said scapula bone and a convex surface adapted to engage said concave dish; wherein when said components are implanted and engaged in a rest position said prosthetic center of rotation is displaced in a direction that is inferior and medial relative to a natural center of rotation and said humerus bone is displaced in a direction that is inferior relative to said natural center of rotation.

Claims

1. A prosthetic joint assembly for joining a humerus bone to a scapula bone, the humerus and scapula bones having a natural center of rotation relative to each other, the humerus bone having a humeral head diameter, the humerus bone being positionable with respect to the scapula bone between a rest position and an abducted position, the prosthetic joint assembly comprising: a. a humeral component having two opposite ends, the first end comprising a humeral stem adapted for rigid engagement with said humerus bone and the second end comprising a concave dish; b. a scapular component having two opposite sides, the first side comprising a scapular base adapted for rigid engagement with said scapula bone and the second side comprising a convex surface adapted to engage said concave dish; c. wherein when said concave dish and said convex surface are engaged, said humeral component freely swivels with respect to said scapular component about a prosthetic center of rotation; d. wherein when said humeral stem is engaged with said humerus bone, said scapular stem is engaged with said scapula bone, and said concave dish and said convex surface are engaged, said prosthetic center of rotation is displaced in a direction that is inferior and medial relative to said natural center of rotation; e. wherein when said humeral stem is engaged with said humerus bone, said scapular stem is engaged with said scapula bone, and said concave dish and said convex surface are engaged, with said humerus in said rest position, said humerus bone is displaced in a direction that is inferior to said natural center of rotation; f. wherein the direction of displacement of said humerus bone is between 75 and 105 degrees below horizontal.

2. The prosthetic joint assembly of claim 1, wherein the ratio of said inferior displacement of said prosthetic center of rotation to said medial displacement of said prosthetic center of rotation is in the range between 0.6 and 1.2.

3. The prosthetic joint assembly of claim 1, wherein the ratio of said inferior displacement of said prosthetic center of rotation to said medial displacement of said prosthetic center of rotation is in the range between 0.85 and 1.15.

4. The prosthetic joint assembly of claim 1, wherein the ratio of said inferior displacement of said prosthetic center of rotation to said medial displacement of said prosthetic center of rotation is approximately 1.

5. The prosthetic joint assembly of claim 1, wherein the distance of displacement of said prosthetic center of rotation relative to said natural center of rotation is between 60% and 80% of the radius of said humeral head.

6. The prosthetic joint assembly of claim 1, wherein the distance of displacement of said humerus bone relative to said natural center of rotation is between 80% and 120% of the radius of said humeral head.

7. A prosthetic joint assembly for joining a humerus bone to a scapula bone, the humerus and scapula bones having a natural center of rotation relative to each other, the humerus bone having a humeral head diameter, the humerus bone being positionable with respect to the scapula bone between a rest position and an abducted position, the prosthetic joint assembly comprising: a. a humeral component having two opposite ends, the first end comprising a humeral stem adapted for rigid engagement with said humerus bone and the second end comprising a concave surface; b. a scapular baseplate having a vertical dimension and two opposite sides, the first side adapted for rigid engagement with said scapula bone, and the second side comprising a trunnion, the trunnion being offset inferiorly relative to a center of said vertical dimension; c. a glenosphere component having two opposite sides, the first side comprising an aperture adapted for rigid engagement with said trunnion, and the second side comprising a convex surface adapted to engage said concave surface; d. wherein when said concave surface and said convex surface are engaged said humeral component freely swivels with respect to said glenospheres about a prosthetic center of rotation.

8. The prosthetic joint assembly of claim 7, wherein said humeral component comprises: a. a stem component having a longitudinal axis and two opposite ends, the first end comprising the humeral stem, and the second end comprising a coupler interface; and b. a coupler component having two opposite ends, the first end comprising a stem interface adapted to rigidly engage said stem component's coupler interface, and the second end comprising a cup interface; c. a cup component having two opposite sides, the first side comprising a coupler interface adapted to rigidly engage said coupler component's cup interface, and the second side comprising said concave surface.

9. The prosthetic joint assembly of claim 7 wherein when said humeral stem is engaged with said humerus bone, said scapular stem is engaged with said scapula bone, and said concave dish and said convex surface are engaged in the rest position: a. said prosthetic center of rotation is displaced in a direction that is inferior and medial relative to said natural center of rotation; and b. said humerus bone is displaced in a direction that is inferior relative to said natural center of rotation; and c. the direction of displacement of said humerus bone is between 75 and 105 degrees below horizontal.

10. The prosthetic joint assembly of claim 9, wherein the ratio of said inferior displacement of said prosthetic center of rotation to said medial displacement of said prosthetic center of rotation is in the range between 0.6 and 1.2.

11. The prosthetic joint assembly of claim 9, wherein the ratio of said inferior displacement of said prosthetic center of rotation to said medial displacement of said prosthetic center of rotation is in the range between 0.85 and 1.15.

12. The prosthetic joint assembly of claim 9, wherein the ratio of said inferior displacement of said prosthetic center of rotation to said medial displacement of said prosthetic center of rotation is approximately 1.

13. The prosthetic joint assembly of claim 9, wherein the distance of displacement of said prosthetic center of rotation relative to said natural center of rotation is between 60% and 80% of the radius of said humeral head.

14. The prosthetic joint assembly of claim 9, wherein the distance of further displacement of said humerus bone relative to said natural center of rotation is between 80% and 120% of the radius of said humeral head.

15. A method for prosthetically joining a humerus bone to a scapula bone, the humerus and scapula bones having a natural center of rotation relative to each other, the humerus bone having a humeral head diameter, the humerus bone being positionable with respect to the scapula bone between a rest position and an abducted position, the method comprising the steps of: a. rigidly engaging a scapular component to said scapula bone; b. rigidly engaging a humeral component to said humerus bone, said humeral component adapted to engage, and freely swivel with respect to, said scapular component about a prosthetic center of rotation; c. wherein upon engagement of said humeral component and said scapular component in said rest position, said humerus bone and prosthetic center of rotation are displaced in a direction that is inferior and medial relative to said natural center of rotation; d. wherein upon engagement of said humeral component to said scapular component in said rest position, said humerus bone is displaced in a direction that is inferior relative to said natural center of rotation; e. wherein the direction of displacement of said humerus bone is between 75 and 105 degrees below horizontal.

16. The method of claim 15 wherein the ratio of said inferior displacement of said prosthetic center of rotation to said medial displacement of said prosthetic center of rotation is in the range between 0.6 and 1.2.

17. The method of claim 15 wherein the ratio of said inferior displacement of said prosthetic center of rotation to said medial displacement of said prosthetic center of rotation is in the range between 0.85 and 1.15.

18. The method of claim 15 wherein the ratio of said inferior displacement of said prosthetic center of rotation to said medial displacement of said prosthetic center of rotation is approximately 1.

19. The method of claim 15, wherein the distance of displacement of said prosthetic center of rotation relative to said natural center of rotation is between 40% and 60% of the radius of said humeral head.

20. The method of claim 15, wherein the distance of displacement of said humerus bone relative to said natural center of rotation is between 80% and 120% of the radius of said humeral head.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] FIG. 1 is an illustration of the bones of the human shoulder in the rest position provided for reference and to illustrate the principles of operation of the present invention.

[0018] FIG. 2 is an illustration of the bones of the human shoulder in the abducted position provided for reference and to illustrate the principles of operation of the present invention.

[0019] FIG. 3 is a close-up view of the interface between the human scapula and humerus bones illustrating the relocation of the center of rotation and humeral bone position in accordance with the present invention.

[0020] FIG. 4 is an isometric view of the scapular component of a shoulder prosthesis according to the present invention.

[0021] FIG. 5 is an exploded orthographic view of the scapular component of the shoulder prosthesis shown in FIG. 4.

[0022] FIG. 6 shows a side view of the scapular component of a shoulder prosthesis shown in FIG. 4.

[0023] FIG. 7 shows multiple sized variations of the scapular component of a shoulder prosthesis according to the present invention.

[0024] FIG. 8 is an isometric view of the humeral component of a shoulder prosthesis according to the present invention.

[0025] FIG. 9 is an exploded orthographic view of the humeral component of the shoulder prosthesis shown in FIG. 8.

[0026] FIG. 10 shows a side view of the humeral component of a shoulder prosthesis shown in FIG. 8.

[0027] FIG. 11 shows multiple sized variations of the humeral component of a shoulder prosthesis according to the present invention.

[0028] FIG. 12 shows, in the rest position, a shoulder prosthesis according to the present invention implanted on human scapula and humerus bones.

[0029] FIG. 13 shows the shoulder prosthesis of FIG. 12 with the humerus and scapula bones removed for clarity.

[0030] FIG. 14 shows, in the abducted position, a shoulder prosthesis according to the present invention implanted on human scapula and humerus bones.

[0031] FIG. 15 shows the shoulder prosthesis of FIG. 14 with the humerus and scapula bones removed for clarity.

[0032] FIG. 16 shows an optional variation of a humeral component according to the present invention which is equipped with a large convex bearing element.

[0033] FIG. 17 shows an optional variation of a humeral component according to the present invention which is equipped with a two-piece concave bearing element.

DETAILED DESCRIPTION OF THE INVENTION

[0034] An object of the prosthesis herein disclosed is to achieve the optimal final placement of the pCOR and the humerus bone as explained in detail in the previous sections and as illustrated in FIG. 3. FIG. 3 is a close-up illustration of the interface between the humerus and scapula showing the vectors of translation, and final placement, of the pCOR and the humerus bone. This optimal positioning is achieved by utilizing a scapular component (100) and humeral components (200) described in detail in the following paragraphs.

[0035] Referring to FIGS. 4, 5, and 6 shown are, respectively, isometric, exploded, and side views fully describing the construction of the scapular component (100). Scapular component (100) comprises a base (102) which is adapted for rigid engagement to the glenoid (5) of the scapular bone (6) through one or more screw holes (104, 106, 108, 110). The screw holes are adapted to receive one or more polyaxial locking screws (112) with corresponding locking caps (114) or single-axis locking screws (116) to affix base (102) to the glenoid (5). The back side (118) of base (102) may optionally include a stem (120) adapted to be implanted into the glenoid (5) to provide additional torsional support for the scapular component (100).

[0036] The front side (122) of base (102) includes trunnion (124) of approximately cylindrical construction. The trunnion (124) can optionally be bored and include an internal thread (148) which is adapted to receive a single-axis locking screw (not shown) or a polyaxial locking screw (126) and a corresponding locking cap (128). The external surface of the trunnion (124) is adapted to receive a glenosphere core (130) which, in turn, is adapted to receive a hollow glenosphere cover (132). The glenosphere core (130) has one or more lobes (134) that closely correspond to matching apertures in the glenosphere cover (132), which ensure that the glenosphere cover (132) does not rotate with respect to the glenosphere core (130) once assembled. When assembled, the glenosphere core (130) and glenosphere cover (132) comprise a spherically shaped glenosphere assembly (144) with an outside surface (152) adapted to interface with humeral component (200).

[0037] The glenosphere core (130) and glenosphere cover (132) feature screw holes (136, 138) that are aligned with trunnion (124) and locking cap (128), and are adapted to receive setting screw (140) to secure the glenosphere assembly (144) to the base (102). The back of locking cap (128) is equipped with internal threads (142) that correspond with the external threads of setting screw (140) for that purpose. In the event that the trunnion (124) is not bored and therefore does not accept polyaxial locking screw (126) and locking cap (128), a hole with internal threads can be placed at the tip of the trunnion (124) to engage with setting screw (140). Although a two-piece glenosphere assembly (144) is shown in the described embodiment, it should be understood that a single piece glenosphere (not shown) can optionally be used with similar effectiveness.

[0038] With the exception of the glenosphere cover (132), all of the components of the scapular component (100) are, preferably, of metallic composition, such as, without limitation, biocompatible surgical-grade alloys like cobalt-chromium-molybdenum (“CoCrMo”) or Titanium alloys well suited for biomedical applications such as joint replacements. Glenosphere cover (132) is manufactured from a durable yet resilient plastic material such as, without limitation, ultra-high-molecular-weight polyethylene (“UHMWPE.”) If a single piece glenosphere is used, it can be of metallic or plastic construction.

[0039] As will be readily observed, trunnion (124) is located well inferior to the center (150) of base (102). This ensures that the center (146) of the glenosphere assembly (144) which will become the prosthetic center of rotation (22), is well inferiorized. Moreover, because center (146) of the glenosphere assembly (144) is located very close to base (102) it is also well medialized. As discussed previously, inferiorization and medialization of the prosthetic center of rotation (22) with respect to the natural center of rotation (8) is one of the primary objectives achieved by the described arrangement of components.

[0040] Referring next to FIG. 7, shown are multiple sized variations of the scapular component (100) which can be utilized depending on the anatomy of the patient and the magnitude and angle of translation of the pCOR (22) desired by the surgeon. As will be seen, some of the sizes include a single attachment screw and corresponding base hole, while others include up to 4 holes and screws. In addition, the shape of the base (102) varies from circular to oval shaped. It should be observed that additional base (102) shapes can be used without departing from the principles of the disclosed invention. The described modular arrangement permits the use of differently sized glenosphere assemblies (144) with differently sized and shaped bases (102) to assemble a scapular component (100) which is optimally adapted to the anatomy of the patient and the desired prosthetic center of rotation (22) location.

[0041] Referring to FIGS. 8, 9, and 10, shown are, respectively, isometric, exploded, and side views fully describing the construction of the humeral component (200). Humeral component (200) comprises a stem (202), a coupler (204), cup (206), and assembly screw (208). Stem (202) is a substantially elongated member comprising a medular stem (210) at one end, and a cone (212) at the other end. Stem (202) is bored through its longitudinal axis to permit assembly screw (208) to enter through the medular stem (210) end and engage coupler (204) at the cone (212) end. Medular stem (210) comprises a typical bone stem adapted to penetrate the medullary canal of the humerus bone (4) and rigidly engage the bone. Medular stem (210) can be adapted for cement or cementless applications. Cone (212) gradually expands in diameter and terminates in one or more fins (214) that are adapted to engage trabecular bone in the humerus bone (4) to transmit torsional loads and prevent stem (202) from rotating once implanted. The top portion of cone (212) comprises a stem shaft opening (218) adapted to receive coupler (204)

[0042] Coupler (204) comprises a stem engagement shaft (220) adapted to engage stem shaft opening (218) and form a secure interference or press fit between stem (202) and coupler (204). In addition, the bottom surface of stem engagement shaft (220) comprises an opening (222) with internal threads (238) that receive the threads (224) of assembly screw (208) after it is inserted through the bottom of the medular stem (210) end of stem (202). In one embodiment stem engagement shaft (220) and shaft opening (218) form a morse taper which provides for a secure frictional fit. In order to make the engagement between the stem (202) and coupler (204) even more secure against torsional forces, stem engagement shaft (220) can optionally be offset from the centerline of stem (202). The combination of a morse taper and the off-center location of stem engagement shaft (220) provide for an extremely robust and torsion resistant fit between stem (202) and coupler (204) once assembly screw (208) is tightened.

[0043] The top surface (226) of coupler (204) comprises a slanted landing area with an opening to receive cup (206). The angle of slant of top surface (226) provides the appropriate angle for displacement of the humerus (4) in the lateral-inferior direction in relation to the pCOR (22) once the prosthesis is assembled. An intermediate coupler section (227) provides additional inferiorization of the humerus bone (4) with respect to the pCOR (22) should it be necessary to achieve optimal placement of the humerus. A cup shaft opening (228) on top surface (226) is adapted to receive cup shaft (230) to secure cup (206) to coupler (204). Cup shaft opening (228) and cup shaft (230) may comprise another morse taper to ensure secure engagement between coupler (204) and cup (206). Additionally, coupler (204) may include one or more medial (232) and lateral (234) suture attachment points.

[0044] One end of cup (206) comprises a concave surface, or dish (236) which closely matches, and is adapted to engage, the outside surface (152) of glenosphere assembly (144) (see FIGS. 4-6.) The other end of cup (206) comprises cup shaft (230) which, as previously discussed, engages in an interference fit, and optionally a morse taper or other type of shallow angle self-holding taper, with cup shaft opening (228) to securely engage cup (206) to coupler (204).

[0045] All of the components of the humeral component (200) are, preferably, of metallic composition, such as, without limitation, biocompatible surgical-grade alloys like cobalt-chromium-molybdenum (“CoCrMo”) or Titanium alloys well suited for biomedical applications such as joint replacements.

[0046] Referring next to FIG. 11, shown are multiple sized variations of the humeral component (200) which can be utilized depending on the anatomy of the patient and the magnitude and angle of further translation of the humerus bone (4) desired by the surgeon. As will be seen, the various sizes include stems (202) of different diameters, cones (212) with varying tapers, intermediate coupler sections (227) of varying lengths, and concave surfaces or dishes (236) of different diameters and curvatures to match corresponding glenosphere assemblies (144). The described modular arrangement permits the use of differently sized stems (202) with differently sized couplers (204) and cups (206) to assemble a humeral component (200) which is optimally adapted to the anatomy of the patient and the optimal displacement of the humerus bone (4) with respect to the prosthetic center of rotation (22).

[0047] The procedure for implanting the disclosed prosthetic shoulder on a patient includes the following generalized steps. First, the size and relative postion of the humerus (4), humeral head (2), scapula(6), glenoid (5), and natural center of rotation (8) of the patient's anatomy are measured. Next, based on these measurements, a scapular component (100), and a humeral component (200), are assembled using the various modular elements, including appropriately sized base (102), glenosphere assembly (144), stem (202), coupler (204), and cup (206) elements. Then, the glenoid (5) is prepared to receive the scapular component (100) which is implanted at the appropriate location to achieve the desired level of inferiorization of the pCOR (22). Next, the humeral head is removed from the humerus (4) and the humeral component (200) is implanted in its place. Finally the scapular component (100) and humeral component (200) are mated and the shoulder joint is tested going from the at rest position to the abducted position and back. If any impingement is detected between the humerus and scapula one or more of the modular elements of the scapular component (100) or the humeral component (200) can be replaced to achieve an optimal alignment of the shoulder joint.

[0048] FIGS. 12 and 13 show views of the presently disclosed prosthetic shoulder joint, fully assembled and implanted in the “at rest” position. Shown in FIG. 12 is an assembled shoulder prosthesis according to the present invention implanted on human scapula (6) and humerus (4) bones. FIG. 13 shows the same assembled prosthesis, including the scapular component (100) and the humeral component (200), with the bones not shown for added clarity. It should be noted that the prosthetic center of rotation (22) is significantly shifted in the medial and inferior direction with respect to the natural center of rotation (8) and that the humerus bone (4) is similarly significantly further shifted in the inferior direction with respect to the natural center of rotation (8). This arrangement positions the humerus bone (4) in the optimal placement for full rotation to the abducted position with minimized risk of impingement on any features of the scapula (6).

[0049] Next FIGS. 14 and 15 show views of the presently disclosed prosthetic shoulder fully assembled and implanted after rotation to the “abducted” position. Shown in FIG. 14 is an assembled shoulder prosthesis according to the present invention implanted on human scapula (6) and humerus (4) bones. FIG. 15 shows the same assembled prosthesis, including the scapular component (100) and the humeral component (200), with the bones not shown for added clarity. As will be appreciated, the prosthetic center of rotation (22) remains significantly shifted in the medial and inferior direction with respect to the natural center of rotation (8). In the abducted position, the humerus bone (4) is now in almost the same position as it would be in a healthy shoulder (see FIG. 2) reflecting the almost complete restoration of the range of movement of the shoulder.

[0050] Variations of the disclosed prosthetic joint are also possible as needed for special situations that may arise from time to time. One such situation occurs when after performing a total reverse shoulder arthroplasty using the disclosed prosthesis it is determined that the patient is no longer a suitable candidate to continue using the reverse shoulder prothesis. This situation could arise due to, for example, failure of the scapula to support the scapular element (100), as a result of re-injury, or due to degenerative changes in the patient. In such a situation, the scapular element can be removed, and the humeral element can be modified to provide a glenosphere, instead of a cup, to interface with the natural glenoid. This avoids having to completely replace the humeral component, a procedure that could be difficult and/or traumatic to the patient. FIG. 16 shows an optional variation of a humeral component (200′) to address such a situation. As shown in this figure, the cup element (206) of the humeral component has been removed, and in its place a large glenosphere (240) is attached to the coupler (204).

[0051] FIG. 17 shows an alternative embodiment of the humeral component (200″) in which the concave bearing surface is manufactured from plastic material, while the remaining parts are metallic. This is achieved by replacing cup (206) with a two-piece component consisting of a metallic tray (242) and a cooperating plastic cup insert (244) which comprises a concave surface.

[0052] While a number of embodiments of the present invention have been described, it is understood that these embodiments are illustrative only, and not restrictive, and that many modifications may become apparent to those of ordinary skill in the art. For example, any element described herein may be provided in any desired size (e.g., any element described herein may be provided in any desired custom size or any element described herein may be provided in any desired size selected from a “family” of sizes, such as small, medium, large). Further, one or more of the components may be made from any of the following materials: (a) any biocompatible material (which biocompatible material may be treated to permit surface bone ingrowth or prohibit surface bone ingrowth—depending upon the desire of the surgeon); (b) a plastic; (c) a fiber; (d) a polymer; (e) a metal (a pure metal and/or an alloy); (f) any combination thereof. Further still, any number of protrusions (e.g., such as for initial fixation by forming a bond with cement and/or such as for supplemental fixation by forming a bond with cement) may be utilized with a given prosthesis. Further still, any number of female features that increase the bonding area may be utilized with a given prosthesis. Further still, any number of male features that could dig into the bone so that initial/supplemental fixation can be improved may be utilized with a given prosthesis. Further still, any number of bone screws (e.g., such as for initial fixation and/or such as for supplemental fixation) may be utilized with a given prosthesis. Further still, any steps described herein may be carried out in any desired order (and any additional steps may be added as desired and/or any steps may be deleted as desired).

[0053] In addition, various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, while the embodiments described above refer to particular features, the scope of this invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations as fall within the scope of the claims, together with all equivalents thereof.