Methods for less invasive glenoid replacement

Information

  • Patent Grant
  • 11696772
  • Patent Number
    11,696,772
  • Date Filed
    Tuesday, November 22, 2022
    a year ago
  • Date Issued
    Tuesday, July 11, 2023
    9 months ago
Abstract
The invention features a glenoid (shoulder socket) implant prosthesis, a humeral implant prosthesis, devices for implanting glenoid and humeral implant prostheses, and less invasive methods of their use for the treatment of an injured or damaged shoulder.
Description
FIELD OF THE INVENTION

The present invention relates to the field of glenoid surface replacement.


BACKGROUND OF THE INVENTION

The invention provides a glenoid shoulder implant, a humeral implant, and devices for preparing the glenoid and humeral head for joint replacement.


Shoulder replacement surgery is currently used to treat patients suffering from disabling pain due to worn or damaged shoulder joints, which can be caused by, e.g., arthritis or injury. The humeral implants currently in use are typically made from metal, and the implants are affixed to the bone using bone cement (e.g., polymethylmethacrylate) or by press fitting the implant into the bone using a roughened outer surface coating on the metal for bony integration. Most glenoid (shoulder socket) implants are made completely from polyethylene and affixed to the cortical bone using bone cement. Some glenoid implants have a metal base plate with a polyethylene insert. Current glenoid implants are made to sit on the surface of a reamed glenoid, which is prepared by removing any remaining cartilage and flattening the bony surface. These implants use either a keel or multiple elongated pegs on the back of the prosthetic glenoid implant to secure the glenoid implant inside the glenoid vault.


Keeled and pegged glenoid implants suffer from several disadvantages, which limit their lifespan once implanted and reduce the number of indications for which they can be used when the age of the patient is a factor. For example, the glenoid implants can loosen due to poor fixation within the bone, and they are prone to wear and fatigue failure of the polyethylene due to adhesion, abrasion, and shear stress. Because of these deficiencies, surgeons hesitate to perform glenoid replacement surgery on young or middle aged patients with glenoid articular cartilage injuries or damage due to early arthritis for fear that the implant may not last more than 10-15 years in the body, thus subjecting the patient to the possibility of two or more surgeries during the lifetime of the patient to preserve the function and pain-free state of the joint. Finally, current glenoid implants with a long keel or pegs are sometimes contraindicated in patients with significant glenoid bone loss. As arthritis progresses, the humeral head can wear medially and destroy the foundation of glenoid bone. In these cases, the glenoid vault can be significantly reduced in volume and depth. Thus, a typical keel or peg design can broach the glenoid vault and injure the suprascapular nerve along the suprascapular notch or spinoglenoid notch with resultant denervation injury to the rotator cuff muscles. Broaching through the glenoid vault can also fracture the body of the scapula and cause early implant loosening.


There are also several disadvantages associated with current glenoid replacement surgical techniques. Current techniques require extensive shoulder exposure with capsular releases in order to fully expose the glenoid surface circumferentially. Since the axillary nerve is located within 1 cm of the inferior capsule, there is potential risk of axillary nerve injury with resultant denervation injury to the deltoid muscle when these releases are performed. However, use of the current keeled or pegged glenoid implants requires this extensive glenoid exposure for proper fitting and placement. Current glenoid replacement surgery also requires a long skin incision and extensive soft tissue stripping in order to fully expose the glenoid circumferentially, which produces a cosmetically unappealing scar. Finally, current glenoid replacement surgical techniques require advanced surgical training and expertise within the specialty of shoulder surgery, yet the majority of shoulder implants performed in the U.S. every year are performed by orthopedic surgeons who do not have advanced training in the subspecialty of shoulder surgery. Therefore, many surgeons have difficulty preparing the glenoid site for a total shoulder replacement using the current techniques.


Because there are more than 20,000 shoulder arthoplasty surgeries performed per year, many U.S. patients incur a risk of continued pain and disability, neuromuscular injuries, or failed shoulder prostheses requiring revision surgery. Thus, there remains a need for an improved glenoid implant and improved methods for performing replacement shoulder surgery.


SUMMARY OF THE INVENTION

There is provided in accordance with one aspect of the present invention, a method of treating a patient. The method comprises the steps of identifying a patient having a glenoid surface, and reaming a cavity into the glenoid surface. A glenoid implant is inserted into the cavity, such that at least a portion of a peripheral edge of the implant resides below the adjacent glenoid surface, and the portion residing below the adjacent glenoid surface is circumferentially surrounded by cortical bone of the glenoid.


The reaming a cavity step may comprise reaming a circular cavity. The inserting a glenoid implant may comprise fitting a glenoid implant having a circular portion into the cavity. The method may additionally comprise the step of securing the implant within the cavity using bone cement, a press-fit or bone screws.


The method may additionally comprise the step of stabilizing the implant within the cavity using a central peg extending from a medial surface of the implant.


The method may additionally comprise the step of accessing the glenoid via a deltapectoral approach. Alternatively, the method may comprise the step of accessing the glenoid via an anterolateral approach.


In certain implementations of the invention, the reaming a cavity step comprises reaming a cavity wholly within the boundary of the native glenoid cavity, without destroying the peripheral margin of the glenoid surface. The reaming a cavity step may be accomplished while leaving the majority of the inferior capsule intact. The reaming a cavity step may comprise reaming a cavity while leaving the peripheral cortex intact. The method may include the step of accessing the glenoid surface via an incision having a length of no more than about 9 cm.


Further features and advantages of the present invention will become apparent to those of skill in the art in view of the detailed description of preferred embodiments which follows, when considered together with the attached drawings and claims.





BRIEF DESCRIPTION OF THE DRAWINGS


FIG. 1A is an anterior surface view of the circular glenoid implant of the invention.



FIG. 1B is an anterior surface view of the oval glenoid implant of the invention.



FIG. 1C is a backside view of the circular glenoid implant of FIG. 1A



FIG. 2A is an anterior surface view of the circular glenoid implant of the invention that includes a single short backside peg.



FIG. 2B is a backside view of the circular glenoid implant of FIG. 2B.



FIG. 3 is an anterior (frontal) view of a typical prior art glenoid implant with a keel design situated in the glenoid.



FIG. 4 is an anterior (frontal) view of a scapula containing a typical prior art glenoid implant with a multiple peg design situated in the glenoid.



FIG. 5 is a backside view of a scapula containing a typical prior art pegged glenoid implant which was removed from a patient.



FIG. 6 is a lateral view of the prior art pegged glenoid implant of FIG. 5.



FIG. 7 is an anterior (frontal) view of a scapula containing an inset glenoid implant of the invention situated in the glenoid.



FIG. 8A is an anterior surface view of a typical prior art glenoid implant.



FIG. 8B is an anterior surface view of the circular glenoid of the invention.



FIG. 9A is a backside view of a typical prior art keeled glenoid trial implant.



FIG. 9B is a backside view of the circular glenoid of the invention showing a short backside peg.



FIG. 10A is a surface view of the glenoid bone with an inset circular glenoid implant of the invention.



FIG. 10B is a surface view of the glenoid bone with an inset oval glenoid implant of the invention.



FIG. 11 is a surface view of the glenoid bone with a typical prior art onlay glenoid implant, which does not sit inset to the glenoid bone.



FIG. 12 is a photograph of a model depicting the glenoid (G), scapula (S), clavicle (C), Acromio-Clavicular Joint (AC), and Coracoid (Co). The glenoid is shaded to designate the placement surface for the glenoid implant of the invention.



FIG. 13 is a view showing the use of a straight drill of the prior art for preparing the glenoid for implantation.



FIG. 14 is a view of the 90° drill of the invention.



FIG. 15 is an anterior (frontal) view of the scapula showing the use of the 90° drill of the invention.



FIG. 16 is a view of the reamer of the invention.



FIG. 17 is frontal view of the humeral cutting jig of the invention



FIG. 18 is side view of the humeral cutting jig of FIG. 17 placed in position on a humerus. The cutting jig can be secured by K-wires (shown), pins, or screws.



FIG. 19 is a view of the humerus and humeral cutting jig of FIG. 18 after resection of humeral head along the axis of the cutting jig.



FIG. 20A is an anterior (frontal) view of the humeral implant of the invention.



FIG. 20B is a lateral view of the humeral implant of the invention.



FIG. 20C is an anterior (frontal) view of the humeral implant of the invention with a collar.



FIG. 20D is a lateral view of the humeral implant of the invention with a collar.



FIGS. 21, 22, and 23 are photographs showing the inset circular glenoid implant of the invention implanted in the glenoid of a patient.



FIG. 24 is a photograph showing the 15 cm incision from a typical prior art total shoulder replacement surgery.



FIG. 25 is a photograph showing the 9 cm incision from the “mini-incision” total shoulder replacement surgery of the invention.



FIG. 26A is a view showing a right angle drill attachment for use in preparing a glenoid for implantation of a glenoid implant.



FIG. 26B is a view showing a drill with the right angle drill attachment and drill bits for use in preparing a glenoid for implantation of a glenoid implant.





DETAILED DESCRIPTION

The invention features an inset glenoid implant prosthesis, a humeral implant prosthesis, and methods and devices for preparing the surgical site for implantation of the implant prostheses.


In one aspect, the invention features an inset glenoid shoulder implant that is implanted within the glenoid vault, thereby allowing circumferential cortical support along the rim of the prosthesis, which improves fixation strength in comparison to current glenoid implants. Another advantage of the glenoid implant is that it requires only a minimal amount of bone removal for implantation.


The glenoid implant itself includes a (1) body portion having (i) a smooth concave lateral articulating surface facing away from the scapula, which is adapted to be engaged by a convex surface of a humeral component, and (ii) an opposing surface on the medial side intended to be positioned within a cavity reamed in the glenoid. In a preferred embodiment, the glenoid implant also includes (2) a short peg on the medial side extending centrally outward along an axis from a convex or flat backside (medial) surface of the glenoid implant. In a preferred embodiment, the short peg of the glenoid implant is less than about 10 mm long, more preferably about 8 mm or less in length, even more preferably about 5 mm or less in length. Alternatively, the glenoid implant has multiple pegs, each of which can be the same length or different lengths, e.g., less than about 8 mm or less in length, more preferably about 5 mm or less in length. In another embodiment, at least one of the pegs is between about 5 mm and about 8 mm in length and the remaining pegs are less than about 8 mm in length.


In another preferred embodiment, the body portion extends to an edge having a circular configuration while, in a second embodiment, the body portion has an edge defining a non-circular configuration, such as an oval, an elongated configuration, or a configuration which may be characterized as rectangular with slightly rounded ends. In another preferred embodiment, the glenoid implant is implanted in a prepared cavity of the glenoid which conforms generally to the backside (medial) surface only and sits inset slightly within the glenoid vault. In another preferred embodiment, the glenoid implant is implanted in a prepared cavity of the glenoid which conforms generally to the single short peg or multiple short pegs, if present, and the backside (medial) surface of the glenoid implant.


In another preferred embodiment, the glenoid implant of the invention is manufactured using polyethylene, metal, or ceramic, or combinations thereof, e.g., a combination of metal and polyethylene or ceramic and polyethylene.


In another preferred embodiment, the glenoid implant of the invention is secured to the glenoid using cement fixation or press fit technique. In yet another preferred embodiment, the glenoid implant is further secured to the glenoid using screws, e.g., in press fit designs.


In another preferred embodiment, the glenoid implant can be customized during the surgical procedure, as is required based on the condition of the patient. In another embodiment, the glenoid implant is sterilized prior to implantation. In yet another embodiment, the glenoid implant is provided in sterile packaging.


In the method of implanting the glenoid component, the first step after exposing the glenoid cavity is to determine the appropriate size of component to be used. This is done by placing a series of circular sizers having varying diameters over the glenoid cavity to determine the proper diameter to which the scapula should be reamed at the surface defining the glenoid cavity and the proper size of glenoid component. Using a combined sizer/guide having a central hole and passageway formed therein to determine the correct location and attitude, a hole is drilled a few millimeters into the scapula through the glenoid surface using a combined guide wire/drill. The guide wire/drill is calibrated in order to readily determine the depth of drilling and is attached to a chuck if a power drill is used or a T-handle or the like if the drilling is manual. The guide wire/drill should be drilled into the scapula substantially perpendicular to the anatomic axis of the glenoid surface. Thereafter, the combined sizer/guide is removed and a reamer is positioned to ream the scapula to the proper shape and depth forming a cavity having a circular cross-sectional configuration for a circular implant or an oval configuration for an oval implant in a plane normal to the axis defined by the guide wire.


In another aspect of the invention, the glenoid implant can be used in patients with deficient glenoid bone due to fracture or severe arthritis. In preferred embodiments, the glenoid implant has none, one, two, or three or more short backside pegs that do not extend beyond about 10 mm outwardly from the backside (medial) surface of the glenoid implant. In a preferred embodiment, the peg or pegs do not extend beyond about 8 mm from the backside (medial) surface of the glenoid implant. Because the glenoid implant lacks a long backside extension, it can be safely placed inside a glenoid vault with minimal depth. This minimizes the risk of fracturing the body of the scapula or injuring the suprascapular nerve or rotator cuff.


Another aspect of the invention features a humeral implant for use in a total shoulder replacement procedure. The humeral implant of the present invention is less than 70 mm in length, preferably about 60 mm in length, and is less than 40 mm wide anterior to posterior (preferably 20 to 30 mm wide). In an embodiment, the humeral implant includes a collar, which prevents the humeral implant from embedding too deeply in the humerus. In other embodiment, the humeral implant includes a flange (fin), which provides fixation of the humeral implant in the medial to lateral plane and rotational control. Alternatively, the humeral implant can contain 3 flanges (fins) with 1 lateral, 1 anterior, and 1 posterior. The stem of the humeral implant defines a longitudinal axis and the planar surface extends from between about 45° to about 60° to the axis of the stem. The proximal end of the stem includes a bore that extends downward from the planar surface and is adapted to be engaged by an artificial humeral head by means of a morse taper. In other embodiments, the humeral implant is fixed using a bone cement, such as polymethylmethacrylate (PMMA) or a compatible fixation material, or it is press-fit without bone cement. The humeral implant can be customized during the surgical procedure, as is required based on the condition of the patient. In another embodiment, the humeral implant is sterilized prior to implantation. In another embodiment, the humeral implant is provided in sterile packaging. In another preferred embodiment, the humeral implant of the invention is manufactured using polyethylene, metal, or ceramic, or combinations thereof, e.g., a combination of metal and polyethylene or ceramic and polyethylene.


Another aspect of the invention features a cutting jig for preparing a humerus for replacement by a humeral implant. The humeral head cutting jig is a simple, low profile humeral cutting jig that can be a fill circle or part thereof. The cutting jig is placed along the anatomic neck of the humerus in the appropriate version (angle of the cut) as determined by the surgeon. The cutting jig can be secured along the anatomic neck of the proximal humerus using K-wires, pins, or screws and is removed after completion of humeral head resection. In an embodiment, the cutting jig includes a handle portion.


Another aspect of the invention features a method for providing a shoulder implant which can be performed through a minimal incision technique (“mini-incision”). Instead of an extensive deltopectoral approach involving extensive soft tissue stripping, capsular releases, and circumferential glenoid exposure, this inset implant can be performed through a more limited mini-incision technique. A mini-deltopectoral incision is utilized. The skin incision is shorter, and the pectoralis tendon is left intact. The majority of the inferior capsule is also left intact. In a preferred embodiment, the glenoid labrum can be left intact if this is preferred by the surgeon. The central portion of the glenoid bone is then reamed while leaving the peripheral cortex intact. There are three major consequences of this mini-incision technique:


1—Shortening the length of the incision and exposure provides a more cosmetic incision for the patient.


2—Avoiding an extensive inferior capule incision increases the safety of the procedure by reducing the risk of injury to the axillary nerve.


3—Providing an implant that can be placed in the glenoid without extensive, circumferential glenoid exposure would allow general orthopedists to perform a shoulder replacement with less difficulty and potentially fewer complications.


The present invention is also directed to a method for implanting such glenoid implant for precise placement in the scapula and precise drilling and reaming of the scapula. The method is performed using a specialized power drill having a 90 degree drilling attachment and a short drill bit incorporated into the attachment, which is used to drill a central hole in the glenoid surface. The bone is then reamed with a reamer bit attached to the drill.


Another aspect of the invention features a slim design power drill for preparing a glenoid for implantation of a glenoid implant, in which the power drill includes a right angle drilling attachment having an extension rod with a length of at least 10 cm, more preferably at least 12, 15, or 18 cm long, the end of which is includes a collet or chuck that is positioned at a 90° angle relative to the extension rod and which is adapted to receive a short drill bit; the power drill being prepared for use in the surgical field by sterilization. In a preferred embodiment, the drill and accessories are sterilized and provided in a sterile container. In other preferred embodiments, the drill bit is 10 mm long, more preferably 12, 14, 16, 18, or 20 mm long, and most preferably 25, 35, 45, 55, 65, or 75 mm long. In other preferred embodiments, the drill bit has the following diameters: 1.5 mm, 2.5 mm, 3.0 mm, 3.2 mm, 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm, 7.0 mm, 8.0 mm, 9.0 mm, or 10.0 mm. The power drill is designed to allow drilling in spaces as tight as 50 mm. In other preferred embodiments, the overall length of the right angle drilling attachment is 18 cm, more preferably 20 cm, most preferably 22 cm. The head width and extension rod diameter are preferably less than 25 mm, more preferably less than 22 mm, and most preferably less than 20 mm. The head length is preferably less than 30 mm, more preferably less than 28 mm, and most preferably less than 25 mm. In other preferred embodiments, the right angle drilling attachment is designed to be attached to any power drill, the use of which is acceptable in a surgical field, and is designed to be lightweight, e.g., less than about 200 grams, more preferably less than about 180 grams, and most preferably less than about 150 grams. The power drill can be powered using a battery supply (cordless) or it can be powered using an electrical cord powered from a standard electrical outlet. See, e.g., U.S. Pat. No. 6,037,724, incorporated herein by reference.


I have used aircraft plane drill (sioux 90 degree air angled drill; part nos. 1 am5551, 775a, and a131oah; www.planetools.com) for preparing a glenoid vault for implantation of a glenoid implant, ensuring that the drill and bit were properly sterilized prior to use. Other drills are known in the art of aircraft maintenance, once properly sterilized, are also useful in the invention (see, e.g., item #00400; www.tightfittools.com).


The design of the glenoid implant of the invention provides increased implant fixation strength to glenoid bone and therefore decreases the rate of glenoid implant loosening. This implant is also designed for use in cases of deficient glenoid bone which would preclude the use of a current glenoid implant since they require adequate bone in the glenoid vault to support multiple long pegs or a keel.


The invention also features a humeral implant, which is less than 70 mm in length, preferably about 60 mm in length, and is less than 40 mm wide from anterior to posterior (preferably 20-30 mm). The humeral implant of the invention is significantly shorter and thinner (in the anterior to posterior dimension) than most current stems, which are about 70-115 mm in length and bulkier in the proximal (metaphyseal) area than distally both in the anterior to posterior dimension and medial to lateral dimension. Because the humeral implant of the invention is shorter, it can be implanted in a narrower metaphyseal area and does not require the removal of a significant amount of bone. Fixation of the present humeral implant depends upon good interference fixation in the medial-lateral plane when press fit (similar to some current total hips). The humeral implant can be fixed using a bone cement, such as polymethylmethacrylate (PMMA) or a compatible fixation material. Alternatively, the humeral implant can be press-fit.


The invention also features a minimal incision shoulder arthroplasty technique that allows replacement of the glenoid surface and humeral head with only a small incision and less extensive soft tissue stripping. The “mini-incision” procedure also leaves the pectoralis tendon and the majority of the inferior capsule intact. The glenoid labrum can also be left intact. The central portion of the glenoid bone is then reamed while leaving the peripheral cortex intact. The advantages of this “mini-incision” procedure include a shorter incision with less scarring, increased safety, and a more simple exposure of the glenoid, thus allowing general orthopedists to perform a shoulder replacement with less difficulty and potentially fewer complications.


The glenoid implant of the invention lacks a keel and multiple long pegs, which are typically present in the prior art glenoid implants. Instead, the glenoid implant of the invention optionally includes only a single short (less than about 8 mm), central backside peg which stabilizes the glenoid implant. The glenoid implant of the invention does not require a long extended keel or long pegs because the majority of the fixation strength is concentrated on the rim of the embedded implant. This obviates the need for significant backside fixation. The fixation, with either cement or press fit techniques, offers circumferential cortical bone fixation around the prosthesis. The shear stresses placed on the implant are therefore supported by a circumferential buttress of bone, which is more mechanically sound than an onlay prosthesis with an extended backside keel or multiple long pegs.


An object of the invention is to minimize the common complications of glenoid implant loosening and fatigue failure that exist with current glenoid implants. All previous glenoid implants sit on the surface of a reamed articular surface and utilize a keel or multiple pegs to secure the implant inside the glenoid vault (see, e.g., FIGS. 3-6). This invention features a glenoid implant (which can be polyethylene, metal, ceramic, or combinations thereof) that is not designed to be placed on the surface of the reamed glenoid articular cartilage, but rather is designed to be inset partially or fully within the glenoid vault (see FIG. 7). The implant may be press fit or cemented in the reamed slot within the glenoid bone.


Patients who can benefit from the use of the glenoid implant of the invention and the improved methods for performing a total shoulder arthoplasty include young, middle, and older patients with arthritis (typical total shoulder replacement (TSR) patients) or damage or injury to the shoulder. This new inset glenoid implant allows TSR surgery for new, previously contraindicated applications, including applications in which the patient presents with bone defects on the glenoid. The glenoid implant of the invention can also be utilized in revision surgeries.


Glenoid Implant Referring now to FIGS. 1A, 1B, and 1C, there is provided glenoid implant (10), which is intended to be implanted in the glenoid as part of a TSR arthroplasty. Glenoid implant (10) replaces the natural glenoid cavity (see G of FIG. 15) and provides a bearing surface against which the head of a humerus or humeral component may articulate. Glenoid implant (10) includes concave articulating surface (14) and convex or flat backside surface (16), which can, optionally, include roughened or textured surface (18). Glenoid implant (10) can be provided as a circular design (FIGS. 1A and 1C) or as an oblong, oval design (FIG. 1B).


Referring now to FIGS. 2A and 2B, glenoid implant (10) can include short, backside peg (12) on the medial, convex or flat backside surface (16) of glenoid implant (10). Short, backside peg (12) is situated centrally on the medial (back) side of glenoid implant (10) and is preferably a cylindrical peg shape that extends outwardly from glenoid implant (10) away from the back of the implant (16).


Glenoid implant (10), including or excluding short, backside peg (12), is adapted to be implanted in a prepared cavity of the glenoid (see, e.g., FIG. 12), such that it is partially or fully inset to the cortical bone of the glenoid, and is retained with bone cement or using press-fit techniques. Glenoid implant (10) can be further secured to the glenoid using one or more screws.


Glenoid component (10) of the present invention includes concave lateral articulating surface (14) against which the head of a humerus or humeral component moves. Glenoid implant (10) is manufactured using a suitable material, for example, polyethylene, metal, ceramic, or combinations thereof, with lateral articulating surface (14) being smoothly contoured. The radius of curvature of the articulating glenoid surface can match the humeral head surface or it can be slightly larger than the radius of curvature of the humeral head implant.


In preferred embodiments, glenoid implant (10) has a lateral articulating surface (14) having a concave circular or oval surface encircled by circular edge (20). Circular edge (20) has a thickness in the range of about 3-6 mm, preferably about 3 mm.


The medial, back side of glenoid implant (10) is preferably roughened or textured. For example, glenoid implant (10) can include a series of elongated groves (18) in multiple locations for receiving bone cement to assist in the cement augmentation and retention of glenoid implant (10).


In preparing the glenoid to receive glenoid implant (10), the glenoid (G; see, e.g., FIG. 12) is reamed to receive all or a portion of glenoid implant (10) so that glenoid implant (10) is circumferentially surrounded by cortical bone of the glenoid (G), which aids in the stabilization and security of glenoid implant (10).


Glenoid Drill and Reamer


Referring now to FIGS. 13-16, there will be described a method for preparing a cavity in the glenoid for receiving a glenoid implant of the present invention and apparatus to be used therewith.


In preparing the cavity in the glenoid (G) to receive glenoid implant (10), the surgeon will initially determine the position of the drill site using a guide known in the art (see, e.g., U.S. Pat. Nos. 6,712,823; 6,364,910; 5,030,219; and 5,489,310; all of which are incorporated by reference).


A reamer of appropriate size is then chosen based on the size of the sizer guide previously chosen. The reamer has a symmetrical head with a plurality of cutting blades and a peripheral stop surface. The previously drilled hole is used as a center guide for the reamer. The reamer is used to create a cavity in the glenoid surface of the scapula in which the prosthetic glenoid component will be installed. After the cavity has been created, the circular or oval glenoid component is installed in the cavity, with or without the use of bone cement.


A method for implanting glenoid implant (10) will now be described with reference to FIGS. 13-16. Initially, if a total shoulder arthroplasty is performed, a humeral implant having a head portion, discussed below, and a glenoid implant are implanted. Prior to implantation of the humeral component into the humerus, glenoid preparation begins. With the glenoid cavity (G) of the scapula (S) exposed, an alignment or pilot hole is first drilled substantially in the center of the glenoid cavity (G) using, e.g., the drill shown in FIGS. 14, 15, and 26. Once the pilot hole is drilled, the glenoid cavity (G) is reamed using a glenoid surface rasp (see bit attached to the drill depicted in FIG. 16) attached to a 90° reamer shaft with driver (see FIG. 26). The glenoid surface rasp may include a guide pin and a roughened cutting surface to create a trough for the glenoid component. The 90° angle of the shaft of the driver permits drilling in tight glenoid cavities. Thus, the procedure can be performed in a minimally invasive manner because it does not require full circumferential exposure of the glenoid, nor does it require a complete capsular release. The 90° shaft of the drill includes a quick-connect attachment which receives the quick-connect drill bit. The reamer is rotated by suitable power means or by hand to ream the glenoid cavity. Following such reaming, the reamer and the guide wire/drill are removed leaving a cavity which is wholly contained within the glenoid cavity (G).


Once the holes have been drilled and the glenoid reamed, a provisional glenoid implant may be used prior to cementing the final glenoid implant to verify hole placement, range of motion, and appropriate glenoid size, and to verify that the glenoid implant is sufficiently inset. After the proper sized glenoid implant has been selected, suitable bone cement, such as polymethylmethacrylate (PMMA) or a compatible fixation material, is placed in the reamed cavity of the glenoid vault and in the roughened outer portions and applied to the medial (back) surface of glenoid implant (10), if cement is to be used. Glenoid implant (10) can then be positioned in the prepared cavity. Glenoid implant (10) is then held in place until the cement cures to assure strong fixation of glenoid implant (10) in the scapula. The head portion of the humerus or humeral component may then engage the concave articulating surface of the glenoid implant (14).


As can be appreciated, the reaming is contained wholly within the boundary of the glenoid cavity (G) and therefore does not destroy the peripheral margin of the glenoid surface. Additionally, as can be seen in FIG. 7, there is preferably a slight overhang of glenoid implant (10) beyond the margin of the natural glenoid cavity.


This method can be performed using a deltopectoral or anterolateral surgical approach. For most cases, a limited deltopectoral incision will be adequate to allow exposure to all involved structures. Use of glenoid implant (10) in the shoulder arthroplasty procedure allows the surgeon to use a “mini-incision technique,” similar to techniques utilized for total knee surgery and total hip surgery.


The glenoid implant of the invention has already been implanted in several patients according to the patient matched implant (PMI) rules and regulations. The implants were designed specifically for patients with inadequate glenoid bone stock which could not support a typical keel or peg design.


Humeral Head Cutting Jig


Referring now to FIGS. 17-19, humeral head cutting jig (26) according to the present invention is a simple, low profile humeral cutting jig that can be a full circle or part thereof. Cutting jig (26) can be secured to the humeral head using K-wires, pins, or screws (27) and is removed after completion of humeral head resection. Cutting jig (26) includes handle portion (28).


The cutting jig should be placed along the anatomic neck of the humeral head. Osteophytes which obscure the junction of the humeral head and humeral shaft should be removed in order to accurately mark the level of the anatomic neck circumferentially from anterior to inferior to posterior. The cutting jig can be fixed to the humerus using wires, pins, or screws at the appropriate angle and version as determined by the surgeon. The rotator cuff should be carefully protected with retractors, and then the humeral cut is performed using an oscillating saw or osteotome along the surface of the cutting jig.


The cutting jig can be manufactured using metal.


Humeral Implant


Referring now to FIGS. 20A-D, humeral implant prosthesis (38) according to the present invention includes stem (40) having elongated portion (42) optionally including collar (44), which prevents humeral implant prosthesis (38) from embedding too deeply in the humerus. Humeral implant (38) also includes flange (fin) (46), which aids in the fixation of the stem in the humerus and prevents rotation of humeral implant in the humerus. There may be just one lateral flange (fin), or there may be two or three flanges (fins), e.g., with one lateral, one anterior, and one posterior. The stem length is preferably less than about 70 mm, and the stem width is preferably less than about 40 mm (preferably about 30 mm).


At the distal end of the stem, there is rounded portion (48) and at the proximal end of the stem is a support surface extending radially from the stem. The support surface has an upper planar surface (50) that includes bore (hole with morse taper) (52) extending inwardly from the top plane thereof, and which is adapted to be engaged by a humeral head implant with a morse taper extension. Modular humeral head implants (both concentric and eccentric) are known in the art (see, e.g., U.S. Pat. Nos. 4,865,605; 5,314,479; 5,462,563, and 5,489,309, and U.S. Patent Application Nos. 2004/0167629, 2004/0064187; each of which is incorporated herein by reference). The plane of upper planar surface (50) is preferably between about 45 degrees and about 60 degrees to the axis of the stem.


The entire stem portion, or a portion thereof, is preferably coated with a porous material for aiding in the fixation of the humeral implant in the humerus for a press fit stem. The implants made for cement fixation can have a smooth surface or a roughened, textured surface.


Humeral implant (38) can be rectangular or rounded edges, but is significantly thinner anterior to posterior than medial to lateral. It will have a morse taper for securing a standard humeral head implant.


An advantage of the humeral implant of the present invention over current humeral implant stems is that the humeral implant of the invention is significantly shorter than most current stems, which are about 70-115 mm in length. Because the humeral implant is shorter, it saves bone because of the narrow metaphyseal area required for implantation. The present humeral implant is less than 70 mm in length, preferably about 60 mm in length, and less than 40 mm anterior-posterior width (preferably about 30 mm). Fixation of the present humeral implant depends upon good interference fixation in the medial-lateral plane when press fit (similar to some current total hips). The humeral implant can be fixed using a bone cement, such as polymethylmethacrylate (PMMA) or a compatible fixation material, or it can be press-fit.


The invention will now be described by the following examples. The following examples are meant to illustrate the invention. They are not meant to limit the invention in any way.


EXAMPLES
Example 1

A 62 year old woman presented with progressive, debilitating shoulder pain from osteoarthritis, which she had experienced for approximately 15 years. She had constant pain (rated 9/10) and difficulty washing her hair, fastening her bra, lifting a cup of coffee, and performing other daily activities. The preoperative radiographs and CT scan showed severe shoulder arthritis and glenoid bone loss that would preclude the use of a keeled or pegged glenoid implant. There was concern that a hemiarthroplasty procedure (replacement of the humeral ball, which would leave the arthritic glenoid socket bare) would not relieve the patient's pain.


A total shoulder replacement using an inset glenoid implant of the invention and a standard humeral implant was performed. The smaller size and circumferential fixation of the inset glenoid implant allowed safe placement of the prosthesis within the confines of the patient's deficient glenoid cavity.


The deficient glenoid vault was not fractured and the fixation was very stable. The patient had 100% relief of pain only 1 week after surgery. Her own assessment of shoulder function 4 weeks after surgery was 56% of normal (American Shoulder and Elbow Society validated outcome score [ASES score]) was 56 compared to 16% of normal before the surgery (ASES score 16).


This surgery was performed through the “mini-incision total shoulder technique” described above. FIG. 25 shows the surgical incision 4 weeks post-operatively. FIG. 24, which shows a more typical total shoulder incision, clearly demonstrates the improved cosmetic appearance and reduced incision size achieved using the “mini-incision total shoulder technique” described above. FIGS. 21-23 are intraoperative pictures of the implanted inset glenoid prosthesis in this patient.


Example 2

An 81 year old woman presented with severe shoulder pain and stiffness. She had severe shoulder arthritis with medial wear causing glenoid bone loss. Her own assessment of shoulder function was 25% of normal (American Shoulder and Elbow Society validated outcome score [ASES score] was 25).


A total shoulder replacement using an inset glenoid implant prosthesis was performed. Two months after her surgery, the patient had no pain and exhibited improved function. Her own assessment of shoulder function was 70% of normal (American Shoulder and Elbow Society validated outcome score [ASES score] was 70).


While the invention has been described in connection with specific embodiments thereof, it will be understood that it is capable of further modifications and this application is intended to cover any variations, uses, or adaptations of the invention following, in general, the principles of the invention and including such departures from the present disclosure that come within known or customary practice within the art to which the invention pertains and may be applied to the essential features hereinbefore set forth.

Claims
  • 1. A method of treating a patient, comprising: providing a glenoid implant having a body, the body comprising a bearing surface, a medial surface opposite the bearing surface, a circumferential peripheral portion defined between the bearing surface and the medial surface, and a radially symmetric central peg extending from said medial surface and oriented along a central axis of the implant, the circumferential peripheral portion defining a cortical-bone-contacting surface;identifying a patient having a glenoid surface;reaming a cavity into the glenoid surface wholly within a boundary of a native glenoid cavity of the patient without interrupting a peripheral margin of the glenoid surface, wherein reaming the cavity comprises: forming a first cavity at a first depth with respect to the glenoid surface and a second cavity at a second depth with respect to the glenoid surface,wherein a diameter of a reamer used to form the first cavity is smaller than a diameter of a reamer used to form the second cavity,wherein the first depth is deeper than the second depth, andwherein the first and second cavities are concentric; andinserting the glenoid implant into the cavity, such that at least a portion of the circumferential peripheral portion of the body resides below the adjacent glenoid surface and the portion residing below the adjacent glenoid surface lies directly adjacent to and is at least partially circumferentially surrounded by cortical bone of the glenoid,wherein the diameter of the reamer used to form the first cavity corresponds to diameter of the central peg,wherein the diameter of the reamer used to form the second cavity corresponds to diameter of the circumferential peripheral portion of the body.
  • 2. The method of treating a patient as in claim 1, wherein reaming the cavity comprises reaming a circular cavity.
  • 3. The method of treating a patient as in claim 1, wherein reaming the cavity comprises reaming an oblong cavity.
  • 4. The method of treating a patient as in claim 1, further comprising securing the implant within the cavity using bone cement.
  • 5. The method of treating a patient as in claim 1, further comprising securing the implant within the cavity by press fit.
  • 6. The method of treating a patient as in claim 1, further comprising securing the implant within the cavity using a bone screw.
  • 7. The method of treating a patient as in claim 1, further comprising stabilizing the implant within the cavity using the peg extending from the medial surface of the implant.
  • 8. The method of treating a patient as in claim 1, further comprising accessing the glenoid via a deltopectoral approach.
  • 9. The method of treating a patient as in claim 1, further comprising accessing the glenoid via an anterolateral approach.
  • 10. The method of treating a patient as in claim 1, further comprising accessing the glenoid via an incision no more than about 9 cm in length.
  • 11. The method of treating a patient as in claim 1, wherein reaming the cavity is accomplished while leaving the majority of the inferior capsule intact.
  • 12. The method of treating a patient as in claim 1, wherein reaming the cavity is accomplished while leaving the peripheral cortex intact.
  • 13. The method of treating a patient as in claim 1, wherein reaming the cavity step is accomplished using a power drill having a 90 degree bend.
CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. application Ser. No. 17/035,500, filed Sep. 28, 2020, which is a continuation of U.S. application Ser. No. 15/640,039, filed Jun. 30, 2017, now U.S. Pat. No. 10,786,265, which is a continuation of U.S. application Ser. No. 13/776,405, filed Feb. 25, 2013, now U.S. Pat. No. 9,693,784, which is a continuation of U.S. application Ser. No. 12/561,528, filed Sep. 17, 2009, now abandoned, which is a continuation application of U.S. patent application Ser. No. 11/066,978, filed Feb. 25, 2005, now U.S. Pat. No. 8,007,538, all of which are incorporated by reference in their entireties and made a part of the present specification.

US Referenced Citations (169)
Number Name Date Kind
2781758 Jacques Feb 1957 A
3979778 Stroot Sep 1976 A
4003095 Gristina Jan 1977 A
4045826 Stroot Sep 1977 A
4206517 Pappas et al. Jun 1980 A
4261062 Amstutz et al. Apr 1981 A
4404693 Zweymuller Sep 1983 A
4550450 Kinnett Nov 1985 A
4865605 Dines et al. Sep 1989 A
4964865 Burkhead et al. Oct 1990 A
4986833 Worland Jan 1991 A
4990161 Kampner Feb 1991 A
5030219 Matsen, III et al. Jul 1991 A
5032132 Matsen, III et al. Jul 1991 A
5080673 Burkhead et al. Jan 1992 A
5108440 Grundei Apr 1992 A
5282865 Dong Feb 1994 A
5314479 Rockwood, Jr. et al. May 1994 A
5314489 Hoffman et al. May 1994 A
5344458 Bonutti Sep 1994 A
5358525 Fox et al. Oct 1994 A
5370694 Davidson Dec 1994 A
5437677 Shearer et al. Aug 1995 A
5462563 Shearer et al. Oct 1995 A
5489309 Lackey et al. Feb 1996 A
5489310 Mikhail Feb 1996 A
5507819 Wolf Apr 1996 A
5514184 Doi May 1996 A
5549683 Bonutti Aug 1996 A
5593448 Dong Jan 1997 A
5702486 Craig et al. Dec 1997 A
5755811 Tanamal et al. May 1998 A
5769856 Dong et al. Jun 1998 A
5800551 Williamson et al. Sep 1998 A
5928285 Bigliani et al. Jul 1999 A
6037724 Buss et al. Mar 2000 A
6228119 Ondria et al. May 2001 B1
6231913 Schwimmer et al. May 2001 B1
6290726 Pope et al. Sep 2001 B1
6334874 Tornier et al. Jan 2002 B1
6364910 Shultz et al. Apr 2002 B1
6368353 Arcand Apr 2002 B1
6379386 Resch et al. Apr 2002 B1
6458136 Allard et al. Oct 2002 B1
6514287 Ondria et al. Feb 2003 B2
6520964 Tallarida et al. Feb 2003 B2
6589281 Hyde, Jr. Jul 2003 B2
6620197 Maroney Sep 2003 B2
6673115 Resch et al. Jan 2004 B2
6679916 Frankle et al. Jan 2004 B1
6679917 Ek Jan 2004 B2
6699289 Iannotti et al. Mar 2004 B2
6709463 Pope et al. Mar 2004 B1
6712823 Grusin et al. Mar 2004 B2
6761740 Tornier Jul 2004 B2
6783549 Stone et al. Aug 2004 B1
6875234 Lipman et al. Apr 2005 B2
7011686 Ball et al. Mar 2006 B2
7044973 Rockwood et al. May 2006 B2
7238089 Tsumuraya et al. Jul 2007 B2
7238208 Camino et al. Jul 2007 B2
7294149 Hozack et al. Nov 2007 B2
7320709 Felt et al. Jan 2008 B2
7329284 Maroney et al. Feb 2008 B2
7465319 Tornier Dec 2008 B2
7517364 Long et al. Apr 2009 B2
7618462 Ek Nov 2009 B2
7678151 Ek Mar 2010 B2
7749278 Frederick et al. Jul 2010 B2
7776098 Murphy Aug 2010 B2
7892287 Deffenbaugh Feb 2011 B2
7922769 Deffenbaugh et al. Apr 2011 B2
8007538 Gunther Aug 2011 B2
8038719 Gunther Oct 2011 B2
8048161 Guederian et al. Nov 2011 B2
8048167 Dietz et al. Nov 2011 B2
8529629 Angibaud et al. Sep 2013 B2
8608805 Forrer et al. Dec 2013 B2
8778028 Gunther et al. Jul 2014 B2
9283083 Winslow et al. Mar 2016 B2
9381086 Ries et al. Jul 2016 B2
9545312 Tornier et al. Jan 2017 B2
9610166 Gunther et al. Apr 2017 B2
9693784 Gunther Jul 2017 B2
10143559 Ries et al. Dec 2018 B2
10492926 Gunther Dec 2019 B1
10779952 Gunther et al. Sep 2020 B2
10786265 Gunther Sep 2020 B2
11065125 Ball Jul 2021 B2
D977643 Ball et al. Feb 2023 S
20010011192 Ondrla et al. Aug 2001 A1
20010037153 Rockwood, Jr. et al. Nov 2001 A1
20010047210 Wolf Nov 2001 A1
20020082702 Resch et al. Jun 2002 A1
20020087213 Bertram, III Jul 2002 A1
20020095214 Hyde, Jr. Jul 2002 A1
20020111689 Hyde, Jr. et al. Aug 2002 A1
20020138148 Hyde, Jr. Sep 2002 A1
20030100952 Rockwood, Jr. et al. May 2003 A1
20030114933 Bouttens et al. Jun 2003 A1
20030125809 Iannotti et al. Jul 2003 A1
20030144738 Rogalski Jul 2003 A1
20030158605 Tornier Aug 2003 A1
20030163202 Lakin Aug 2003 A1
20030236572 Bertram, III Dec 2003 A1
20040002766 Hunter et al. Jan 2004 A1
20040039449 Tornier Feb 2004 A1
20040039451 Southworth Feb 2004 A1
20040059424 Guederian et al. Mar 2004 A1
20040064187 Ball et al. Apr 2004 A1
20040064189 Maroney et al. Apr 2004 A1
20040064190 Ball et al. Apr 2004 A1
20040107002 Katsuya Jun 2004 A1
20040122519 Wiley et al. Jun 2004 A1
20040122520 Lipman et al. Jun 2004 A1
20040167629 Geremakis et al. Aug 2004 A1
20040167630 Rolston Aug 2004 A1
20040193168 Long et al. Sep 2004 A1
20040193275 Long et al. Sep 2004 A1
20040193276 Maroney et al. Sep 2004 A1
20040193277 Long et al. Sep 2004 A1
20040193278 Maroney et al. Sep 2004 A1
20040220674 Pria Nov 2004 A1
20040230311 Cyprien et al. Nov 2004 A1
20040260398 Kelman Dec 2004 A1
20050043805 Chudik Feb 2005 A1
20050049709 Tornier Mar 2005 A1
20050065612 Winslow Mar 2005 A1
20050107882 Stone et al. May 2005 A1
20050119531 Sharratt Jun 2005 A1
20050177241 Angibaud et al. Aug 2005 A1
20050261775 Baum et al. Nov 2005 A1
20050278030 Tornier et al. Dec 2005 A1
20060036328 Parrott et al. Feb 2006 A1
20060069443 Deffenbaugh et al. Mar 2006 A1
20060069444 Deffenbaugh Mar 2006 A1
20060069445 Ondrla et al. Mar 2006 A1
20070038302 Shultz et al. Feb 2007 A1
20070050042 Dietz et al. Mar 2007 A1
20070055380 Berelsman et al. Mar 2007 A1
20070112433 Frederick et al. May 2007 A1
20070225817 Reubelt et al. Sep 2007 A1
20070225818 Reubelt et al. Sep 2007 A1
20080021564 Gunther Jan 2008 A1
20080234820 Felt et al. Sep 2008 A1
20090125113 Guederian et al. May 2009 A1
20090228112 Clark et al. Sep 2009 A1
20100087876 Gunther Apr 2010 A1
20100087877 Gunther Apr 2010 A1
20100114326 Winslow et al. May 2010 A1
20100274360 Gunther Oct 2010 A1
20110144758 Deffenbaugh Jun 2011 A1
20110276144 Wirth et al. Nov 2011 A1
20110313533 Gunther Dec 2011 A1
20130060346 Collins Mar 2013 A1
20130166033 Gunther Jun 2013 A1
20150105861 Gunther et al. Apr 2015 A1
20170202674 Gunther et al. Jul 2017 A1
20210038401 Ball et al. Feb 2021 A1
20210137693 Ball et al. May 2021 A1
20210244547 Gunther et al. Aug 2021 A1
20210251640 Gunther Aug 2021 A1
20210338446 Ball Nov 2021 A1
20220151795 Running et al. May 2022 A1
20220175543 Ball Jun 2022 A1
20220175544 Ball et al. Jun 2022 A1
20230078024 Gunther et al. Mar 2023 A1
20230080207 Gunther et al. Mar 2023 A1
20230090753 Running et al. Mar 2023 A1
Foreign Referenced Citations (12)
Number Date Country
4220217 Dec 1993 DE
10164328 Jul 2003 DE
0299889 Jan 1989 EP
0339530 Nov 1989 EP
0570816 Nov 1993 EP
1464305 Oct 2004 EP
1952788 Aug 2008 EP
2083759 Sep 2015 EP
2248820 May 1975 FR
2567019 Jan 1986 FR
2695313 Mar 1994 FR
WO 2009071940 Jun 2009 WO
Non-Patent Literature Citations (28)
Entry
Biomet. “Absolute™ Bi-Polar.” 2001 in 2 pages.
Biomet, “Copeland”™ Humeral Resurfacing Head, Interlok®/HA Coated Implant Information, 2003 in 1 page.
Biomet, “Copeland”™ Humeral Resurfacing Head, 2001 in 12 pages.
Biomet, “Copeland™ Humeral Resurfacing Head, Macroband™ Implant Informations,” 2003 in 1 page.
Biomet, “Copeland™ Humeral Resurfacing Head. Surgical Technique,” 2003 in 2 pages.
Boileau et al., “The Three-Dimensional Geometry of the Proximal Humerus. Implications for Surgical Technique and Prosthetic Design,” J. Bone Joint Surg. Br. 79: 857-865, 1997.
Braun, et al., Modular Short-stem Prosthesis in Total Hip Arthropiasty: Implant Positioning and the Influence of Navigation, ORTHO SuperSite (Oct. 2007) in 8 pages.
Clavert et al. Glenoid resurfacing: what are the limits to asymmetric reaming for posterior erosion? J. Shoulder and Elbow Surg. Nov./Dec. 2007: 843-848.
Dalla Pria, Paolo. Slide presentation, entitled “Shoulder Prosthesis Design and Evolution”, to the Naples International Shoulder Congress in Italy (2000) in 55 pages.
DePuy, “Global GAP, Surgical Technique Resurfacing Humeral Head Implant,” 2004 in 23 pages.
Inset Mini-glenoid Brochure, Ascension Orthopedics, 2011, 4 pages.
Karduna et al. Glenhumeral Joint Translations before and after Total Shoulder Arthroplasty. J. Bone and Joint Surg. 79(8) (1997): 1166-1174.
Redacted letter from a third party dated Aug. 24, 2012 in 2 pages.
Levy et al., “Cementiess Surface Replacement Arthroplasty of the Should. 5- to 10-year Results with the Copeland Mark-2 Prosthesis,” J. Bone Joint Surg. Br. 83: 231-221, 2001.
Lima-Lto Medical Systems Glenoidl/Glenoids catalogue (2001) in 1 page.
Lima-Lto Miniglenoide Cementata document 7560.50.030 (1999) in 1 page.
Panisello, at al., Bone remodelling after total hip arthroplasty using an uncemented anatomic femoral stem: a three-year prospective study aging bone densitometry, J Ortho Surg 14(1):32-37 (2006).
Ross, Mark and Duke, Phillip, “Early Experience in The Use of a New Glenoid Resurfacing Technique” Glenoid Presentation, SESA Nov. 4, 2006, Session 4/0800-0930 p. 93 in 1 page.
Search Report and Written Opinion PCT/US2006/006330 dated Jan. 24, 2008 in 10 pages.
Office Action in Australian Application No. 2011224694 dated Sep. 2, 2013 in 2 pages.
Office Action in European Application No. 11753831.4 dated Nov. 16, 2016 in 3 pages.
Tight Fit Tools, Right Angle Drill Attachment, Serial No. 00400 www.tightfittools.com/riganat.html in 1 page.
TITAN(TM) Modular Shoulder System Brochure, 2011 available at http://www.ascenslonortho.com/Assets/PDF/TitanModular/TITANModularShoulder_Brochure-revD.pdf (2 pages).
Tournier et al., Enhancement of Glenoid Prosthesis Anchorage using Burying Technique. Techniques in Shoulder & Elbow Surgery 9(1)(2008): 35-42.
Wang at al., Biomechanical Evaluation of a Novel Glenoid Design in Total Shoulder Arthroplasty. J. Shoulder & Elbow Surgery (2005) 15: 129S-140S.
Statement of Grounds and Particulars of Opposition for Australian Patent Application No. 2006218936 dated Oct. 5, 2012 in 8 pages.
U.S. Appl. No. 16/701,118, filed Dec. 2, 2019, Gunther.
U.S. Appl. No. 29/870,666, filed Feb. 1, 2023, Ball et al.
Related Publications (1)
Number Date Country
20230081505 A1 Mar 2023 US
Continuations (5)
Number Date Country
Parent 17035500 Sep 2020 US
Child 18058150 US
Parent 15640039 Jun 2017 US
Child 17035500 US
Parent 13776405 Feb 2013 US
Child 15640039 US
Parent 12561528 Sep 2009 US
Child 13776405 US
Parent 11066978 Feb 2005 US
Child 12561528 US