Patent Application
20170252171
The present invention relates to prosthetic joints. More specifically, a prosthetic joint having an improved connection to the medullary canals is provided. Additionally, a prosthetic joint that may be used for either partial or total joint replacement is provided.
There are three bones in the elbow: the humerus, the ulna, and the radius. These three bones articulate in the ulnohumeral, radiohumeral and radioulnar joints. Each of the joint surfaces is covered with articular cartilage and motion occurs at these articulations with distinct motion profiles. The cartilage allows the bones to slide easily against one another as the joint moves through its range of motion. The ulnohumeral joint is most essential for transmitting forces through the elbow.
Degenerative joint diseases such as Osteoarthritis as well as inflammatory arthritides such as Rheumatoid arthritis commonly affect the elbow joints and causes articular degeneration and marginal bone formation. In post-traumatic settings, where surgical efforts have failed to restore adequate alignment, post-traumatic arthritis may set in and become symptomatic with patients experiencing pain and a loss of range of motion. Whether idiopathic, inflammatory or post-traumatic, elbow arthritis is often painful and may interfere with function of the entire arm.
Initial non-operative intervention often includes splinting and steroid injections. Elbow joint synovectomy and debridement of arthritic spurs are surgical options when the cartilage damage is limited. Arthodesis (i.e., joint fusion) is an option for very damaged joints and is rarely used as elbow range of motion is sacrificed. Functional requirements of the patient often necessitate a durable solution that maintains range of motion. Accordingly, numerous prior efforts have been undertaken to replace this joint.
Whereas degenerative joint diseases usually affect patients after the fifth decade of life, traumatic conditions may cause elbow joint impairment in younger age groups. Elbow fractures such as of the distal humerus or olecranon often exhibit intra-articular involvement, which can lead to permanent cartilage damage despite the best surgical reconstruction efforts. This is particularly true when anatomic reconstruction of the joint surfaces is not successful or if osteochondral portions are missing as may occur in open injuries. In these settings, consideration for a primary joint replacement as an option may be given. Often, only a portion of the elbow joint is injured such as the distal humerus and it may benefit from reconstruction. High energy injuries such as Motorcycle accidents may damage the distal humerus of younger patients and leave the ulna and radius relatively uninjured. Thus, the ability to replace either the distal humerus only (hemiarthroplasty) or the entire elbow (total arthroplasty) is quite helpful.
Initial joint replacement efforts were done as early as 1947, when surgeons employed custom made hinges to replace elbow joints. However, the results of these early efforts were characterized by implant loosening, instability and poor clinical results. Hurri L, Pulkki T, Vainio K. Arthroplasty of the Elbow in Rheumatoid Arthritis, ACTA CHIR SCAND 964; 127:459-465; Dee R. Total Replacement Arthroplasty of the Elbow for Rheumatoid Arthritis, J BONE JOINT SURG BR 1972; 54 (1):88-95; Cross M B, Sherman S L, Kepler C K et al. The Evolution of Elbow Arthroplasty: Innovative Solutions to Complex Clinical Problems, J BONE JOINT SURG AM 2011; 92 Suppl 2:98-104. In the 1970s, the first simple hinged elbow prostheses were implanted using cementing techniques. Cross M B, Sherman S L, Kepler C K et al. The Evolution of Elbow Arthroplasty: Innovative Solutions to Complex Clinical Problems, J BONE JOINT SURG AM 2011; 92 Suppl 2:98-104. This improved the stability of the construct, but still resulted in rates of loosening of up to 50%. Garrett J C, Ewald F C, Thomas W H et al. Loosening Associated with G.S.B. Hinge Total Elbow Replacement in Patients with Rheumatoid Arthritis, CLIN ORTHOP RELAT RES 1977; (127):170-174. As a result of these observations, different design concepts have emerged: linked, unlinked, convertible and modular elbow prostheses.
Linked, or “semi-constrained,” prostheses are commonly used implants and employ a “sloppy hinge” mechanism that allows for some varus, valgus, and rotational movement. The linked design offers superior stability and dislocations of these joints are rare, however, the constrained design transfers forces through the bone-cement or bone-implant interface which then results in significant loosening rates.
Unlinked or “unconstrained” prosthesis designs work without a mechanical linkage between the components. These prostheses can be implanted while maintaining good bone stock and offer decreased polyethylene wear when compared to their linked counterparts. Since there is no mechanical linkage between the components, the stability of the construct relies greatly on the soft tissues around the elbow. It is believed that a well-balanced soft tissue envelope reduces stress at the bone-cement and bone-implant interfaces which results in lower loosening rates compared to linked designs. Understandably, this reliance on soft tissues to maintain stability results in higher rates of instability and joint dislocation compared to linked designs. These characteristics prevent the use of an unlinked prosthesis in situations where soft tissue integrity is poor or extensive bone loss has occurred.
Total elbow arthroplasty systems have been developed that allow intra-operative decision making with regards to what type of implant may be best suited. “Convertible” systems have been developed that allow the placement of either a semi-constrained or an unconstrained construct based on the soft tissue integrity of the patient. These designs allow intraoperative conversion between unlinked and linked inplants as dictated by the integrity of the soft tissues and bone.
Modular arthroplasty relates to replacement of a portion of the elbow joint. Total elbow arthroplasty may not be an ideal solution for younger patients. This group may benefit from replacement of only those regions that are damaged while preserving unaffected joint surfaces. On occasion, the distal humerus is severely injured with relative sparing of the proximal ulna or radius. In some instances, such as high energy motor vehicle accidents, the distal humerus is not salvageable. Thus, the ability to replace either the distal humerus only (hemiarthroplasty) or the entire elbow (total arthroplasty) is quite helpful. A modular system would then also allow the surgeon to add implants at a later time as subsequent wear and tear of the remaining native joint surfaces may occur.
A currently available modular elbow arthroplasty system is the UNI-Elbow Radio Capitellum System (Small Bone Innovations) that allows for replacement of the radio-humeral joint in isolation. It is a Uni-compartmental arthroplasty of the elbow where the lateral side of the elbow is replaced in isolation. Additionally, the Latitude Total Elbow prosthesis (Tornier, USA) is a total elbow replacement system whose distal humerus component matches native anatomy closely and can be used in isolation (hemiarthroplasty) in instances where the ulna is in good condition.
In a case series on hemiarthroplasty for distal humerus fractures in elderly patients using the Latitude System mainly good to excellent short-term results based on a Mayo score and good functional results were achieved. None of the complications required implant removal and only in one case did progressive osteoarthritis of the proximal ulna and radius occur. These results only represented a mean follow-up of 12.1 months, however, and therefore must be interpreted cautiously. Burkhart K J, Nijs S, Mattyasovszky S G et al. Distal Humerus Hemiarthroplasty of the Elbow for Comminuted Distal Humeral Fractures in the Elderly Patient, J TRAUMA 2011; 71 (3):635-642. The use of the Kudo prosthesis for hemiarthroplasty purposes has been described in a small case series with reasonable functional outcome after a mean of 4 years status after implantation. However, radiographic signs of attrition indicate that this implant may not be ideally suited for this role. Adolfsson L, Nestorson J. The Kudo Humeral Component as Primary Hemiarthroplasty in Distal Humeral Fractures, J SHOULDER ELBOW SURG 2012; 21 (4):451-455.
At this time, all commercially available implants whether linked, unlinked, convertible or modular are cemented in place. Even though this offers a quick, reliable, and relatively durable bone-to-implant fixation, there are significant limitations. The most noteworthy is that the implant and cement mantle is difficult to remove if this is required such as in the face of an infection or peri-prosthetic fracture. If the implant is merely loose and improved fixation is required, then the cement can be removed where it is loose and left in place where it is often quite inaccessible. It is when eradicating an infection, however, when the entire cement mantle needs to be accounted for and eliminated, that the surgical effort to accomplish this becomes quite involved. Damage to the soft tissues as well as neurovascular structures can occur and, even in the best of circumstances, significant bone stock is removed along with the cement. To address the subsequent bone loss, Zimmer (Warsaw, Ind., USA) markets a method whereby new bone is introduced through impaction grafting around a repeat cement mantle when a second implant is placed in a revision arthroplasty setting. With patients living longer and more active lives, it is of paramount importance to offer an implant that can be rigidly placed but then also removed without undue trauma to the bones and the soft tissue envelope into which they gain fixation.
The use of cement has the potential added drawback of causing thermal osteonecrosis. The cement is inserted at room temperature into the intramedullary canal to secure an implant and employs an exothermic reaction to become hard. This high temperature may damage the surrounding bone and potentially compromise its ability to heal after implant installation. It may also hinder new bone growth advantageous to helping secure the implant after installation.
Elbow arthroplasty carries serious potential complications. The most dire complication is the development acute, subacute, or chronic infections. The soft tissue envelope that surrounds the elbow is thin, thereby making this location vulnerable to this complication. The incidence of deep infections after Total Elbow Arthroplasty lies between 3 and 8%. Kim J M, Mudgal C S, Konopka J F et al. Complications of Total Elbow Arthroplasty, J AM ACAD ORTHOP SURG 2011; 19 (6):328-339; Tachihara A, Nakamura H, Yoshioka T et al., Postoperative Results and Complications of Total Elbow Arthroplasty in Patients with Rheumatoid Arthritis: Three Types of Nonconstrained Arthroplasty, MOD RHEUMATOL 2008; 18 (5):465-471; Gschwend N, Simmen B R, Matejovsky Z. Late Complications in Elbow Arthroplasty, J SHOULDER ELBOW SURG 1996; 5 (2 Pt 1):86-96. The causative organism is usually Staph. Aureus or Epidermidis. Staph. Epidermidis is considered more virulent due to its ability to form biofilms. In most patients the time span between index arthroplasty and revision is more than three weeks and spontaneous drainage after ten days may be indicative of deep bacterial colonization. Kim J M, Mudgal C S, Konopka J F et al. Complications of Total Elbow Arthroplasty, J AM ACAD ORTHOP SURG 2011; 19 (6):328-339.
Infections after Total Elbow Arthroplasty should be managed aggressively and resection arthroplasty may be warranted. Resistant infections are managed by hardware removal and debridement of all affected structures including bone, soft tissues and bone cement. Because of the significant recurrence rate, re-implantation should only be performed cautiously given that prosthesis survival is significantly diminished in those cases (77% 3-year, 48% 8-year survival). Kim J M, Mudgal C S, Konopka J F et al. Complications of Total Elbow Arthroplasty, J AM ACAD ORTHOP SURG 2011; 19 (6):328-339. Given that the cement must be removed in addition to the implant in order to eradicate the infection, the likelihood of having reasonable bone stock remaining after the implant and bone cement has been removed is low. Realizing the low survival rate of the second implant, the decision to re-implant a new arthroplasty is often met with significant resistance. Most patients do not want to undergo a re-implantation effort. Having an implant system that contains no cement and can be removed much more easily when compared to its cemented brethren would minimize the bone loss associated with implant removal and increase the likelihood of subsequent re-implantation.
Peri-prosthetic loosening may occur after implantation and often requires revision surgical efforts. Bennett J B, Mehlhoff T L. Total Elbow Arthroplasty: Surgical Technique, J HAND SuRG AM 2009; 34 (5):933-939. To ensure longevity, patients must be willing to accept a lifelong 5-lb lifting restriction to that extremity. Bennett J B, Mehlhoff T L. Total Elbow Arthroplasty: Surgical Technique, J HAND SURG AM 2009; 34 (5):933-939. In general, the ulnar components are at the highest risk for aseptic loosening and this risk is associated with the quality of fixation. An estimated 7 to 17% of all total elbow arthroplasties show clinical loosening, whereas the rate of radiographic loosening is even higher. Kim J M, Mudgal C S, Konopka J F et al. Complications of Total Elbow Arthroplasty, J AM ACAD ORTHOP SURG 2011; 19 (6):328-339. Tachihara A, Nakamura H, Yoshioka T et al. Postoperative Results and Complications of Total Elbow Arthroplasty in Patients with Rheumatoid Arthritis: Three Types of Nonconstrained Arthroplasty, MOD RHEUMATOL 2008; 18 (5):465-471; Gschwend N, Simmen B R, Matejovsky Z. Late Complications in Elbow Arthroplasty, J SHOULDER ELBOW SURG 1996; 5 (2 Pt 1):86-96. The design of a semi-constrained elbow prosthesis, allowing for an element of varus-valgus laxity, is thought to reduce the incidence of aseptic loosening. Ensuring both accurate implant positioning as well as excellent cement fixation are crucial to minimize stress on the implant as well as the development of aseptic loosening. Kim J M, Mudgal C S, Konopka J F et al. Complications of Total Elbow Arthroplasty, J AM ACAD ORTHOP SURG 2011; 19 (6):328-339. Revision arthroplasty should be considered in the setting of instability and pain. When this happens, both the prosthesis and cement should be removed using adequate instruments. Sometimes an osteotomy or the creation of bone windows is needed. Cementless implantation is rarely employed. Uncemented elbow arthroplasty in rheumatoid arthritis patients was described utilizing the Kudo prosthesis which demonstrated a high rate of aseptic loosening (7 of 49) within the ulnar component ultimately leading to an inability to recommend this implant without the use of cement fixation. Brinkman J M, de Vos M J, Eygendaal D. Failure Mechanisms in Uncemented Kudo Type 5 Elbow Prosthesis in Patients with Rheumatoid Arthritis: 7 of 49 Ulnar Components Revised Because of Loosening After 2-10 years, ACTA ORTHOP 2007; 78 (2):263-270.
Periprosthetic fracture after primary total elbow arthroplasty occurs with an incidence of 5 to 29% with underlying causes including direct trauma, osteoarthritis, or aseptic loosening. Kim J M, Mudgal C S, Konopka J F et al. Complications of Total Elbow Arthroplasty, J AM ACAD ORTHOP SURG 2011; 19 (6):328-339. Tachihara A, Nakamura H, Yoshioka T et al. Postoperative Results and Complications of Total Elbow Arthroplasty in Patients with Rheumatoid Arthritis: Three Types of Nonconstrained Arthroplasty, MOD RHEUMATOL 2008; 18 (5):465-471; Hildebrand K A, Patterson S D, Regan W D et al. Functional Outcome of Semiconstrained Total Elbow Arthroplasty, J BONE JOINT SURG AM 2000; 82-A (10):1379-1386; O'Driscoll S W, Morrey B F. Periprosthetic Fractures about the Elbow, ORTHOP CLIN NORTH AM 1999; 30 (2):319-325. Periprosthetic elbow fracture treatment has been characterized in the literature. O'Driscoll S W, Morrey B F. Periprosthetic Fractures about the Elbow, ORTHOP CLIN NORTH AM 1999; 30 (2):319-325; Foruria A M, Sanchez-Sotelo J, Oh L S et al. The Surgical Treatment of Periprosthetic Elbow Fractures Around the Ulnar Stem Following Semiconstrained Total Elbow Arthroplasty, J BONE JOINT SURG AM 2011; 93 (15):1399-1407; Sanchez-Sotelo J, O'Driscoll S, Morrey B F. Periprosthetic Humeral Fractures After Total Elbow Arthroplasty: Treatment with Implant Revision and Strut Allograft Augmentation, J BONE JOINT SURG AM 2002; 84-A (9):1642-1650.
Not all fractures require surgical treatment and immobilization may be sufficient in some cases. With significant displacement, open reduction and internal fixation should be performed. In these cases the bone stock at the fracture site dictates the technique used such as cerclage wiring or plate fixation. A significant hardship when treating periprosthetic fractures involves the cement mantle that surrounds the implant. As it lies within the fractured bone and exhibits no healing capability, the cement often has to be removed and then the void filled with bone graft. Not all periprostetic fractures are associated with implant loosening yet frequently these two occur in combination mandating a revision-arthroplasty effort in addition to the fracture open reduction and internal fixation. Sanchez-Sotelo J, O'Driscoll S, Morrey B F. Periprosthetic Humeral Fractures After Total Elbow Arthroplasty: Treatment with Implant Revision and Strut Allograft Augmentation, J BONE JOINT SURG AM 2002; 84-A (9):1642-1650. Some cases even require two-staged treatment where fracture union is achieved first and revision arthroplasty is done in a second step. Tokunaga D, Hojo T, Ohashi S et al. Periprosthetic Ulnar Fracture After Loosening of Total Elbow Arthroplasty Treated by Two-Stage Implant Revision: A Case Report, J SHOULDER ELBOW SURG 2006; 15 (6):e23-26. If significant loss of bone stock is present within the distal humerus or proximal ulna, successful surgical revision may not be possible leading to salvage options such as an arthrodesis or leaving the elbow flail or even consideration of an amputation.
Other complications may occur that are unrelated to the method of component fixation. For example, ulnar nerve irritation is a concern with any extensive surgery around the elbow and triceps insufficiency may occur either in the acute or later stages.
Bone cement implantation syndrome (BCIS) is a unique problem associated with cement fixation of an implant. It occurs primarily in association with cemented Total Hip arthroplasty. It is characterized by hypoxia, hypotension or both and/or unexpected loss of consciousness occurring around the time of cementation, prosthesis insertion, reduction of the joint or, occasionally, limb tourniquet deflation in a patient undergoing cemented bone surgery. Bone cement implantation syndrome (BCIS) is poorly understood and yet is an important cause of intraoperative mortality and morbidity in patients undergoing cemented hip arthroplasty and may also be seen in the postoperative period in a milder form causing hypoxia and confusion. Currently, when preparing for cementation, the anesthesiologist is informed that the cementation process is being started so as to closely monitor any adverse intra-operative effect. Our design does not include cement fixation at all and, thereby, eliminates this risk. A. J. Donaldson, H. E. Thomson, N. J. Harper and N. W. Kenny. Bone cement implantation syndrome, BR J ANAESTH 2009; 102: 12-22.
Different devices for the prosthetic treatment of the elbow joint have been developed. Commercially available systems for elbow arthroplasty at the present time include:
All of the above elbow prostheses are secured to the respective bones with bone cement and, therefore, carry all of the disadvantages inherent in bone cement.
Numerous other elbow prostheses have been proposed. For example, U.S. Pat. No. 2,696,817 discloses a prosthetic elbow joint comprising two threaded shafts that are separately inserted into the medullary canals. The threads of each shaft cut mating threads or grooves in the walls of the bone cavity to prevent axial displacement and rotational displacement. After installation into the respective bones, these shafts are connected with a low friction bearing.
U.S. Pat. No. 3,547,115 discloses a prosthetic replacement of the articular surface of the distal humerus that is attached by trimming the bone to match the inner surface of the prosthesis and is locked in place by a keyhole-type mechanism. An intramedullary stem fixation method is not intended. This patent only replaces the distal humerus.
U.S. Pat. No. 3,708,805 discloses a prosthetic elbow joint. The humeral member and ulnar member are connected to form a hinge. The male portion of the hinge corresponds to the surface of the female portion of the hinge to avoid tissue being trapped therein. The stems used to cement each component to the bone are non-round to prevent rotation, and tapered to facilitate removal. The ulnar stem is curved eight inches, and the humerus stem is curved three inches. The elbow joint itself is angled to correspond to a natural elbow. This joint is designed for assembly prior to insertion. The hinge appears to prohibit any varus and valgus laxity.
U.S. Pat. No. 3,772,709 discloses an elbow prosthesis having a humeral component made of steel, and an ulnar component made of silicone. The components are held together using a metal pin, and are secured to the respective bones using cement.
U.S. Pat. No. 3,816,854 discloses a prosthesis for total arthroplasty of the elbow joint. The humeral and ulnar components are cemented to the bones with stems having a square cross-section. The ulnar component includes a cylindrical polyethylene bearing that articulates with a mating concave cylindrical surface defined by the humeral component.
U.S. Pat. No. 3,852,831 discloses an endoprosthetic elbow joint. The elbow joint includes a humeral component including a cylindrical bearing surface that is widest at its ends, tapering to a narrow center. This component articulates with an ulnar component that is saddle shaped. The wear surface of the ulnar component can be releasably connected with a dovetail connection. The humeral and ulnar components are retained together by the patient's joint capsule, making this an unconstrained joint.
U.S. Pat. No. 3,868,730 discloses a knee or elbow prosthesis. This prosthesis incorporates a coupled ball and socket connection. Although the title indicates that either an elbow or knee could be replaced, this reference is directed primarily towards knee replacement. A ball on a connecting rod extending upwardly from the tibial component is enclosed by a high density polyethylene socket insert retained within the bottom of the femoral component. The joint is designed to permit a slight degree of twisting or wobbling.
U.S. Pat. No. 3,919,725 discloses a hingeless endoprosthetic device for the elbow joint that comprises humeral and ulnar components. The cylindrical humeral surface is intramedullary fixed. The complementary ulnar component is made from silicone and sits within the ulna. The absence of long stems going into the bone is described as an advantage by this reference, providing for ease of installation and less removal of bone. The hingeless design is called advantageous due to the ease of installation and reduced chances of loosening. This unconstrained device requires that the patient's natural soft tissues are functional.
U.S. Pat. No. 3,939,496 discloses an endoprosthetic joint. The joint includes a humeral component having a pair of spherical bearing members. The ulnar component has a bearing block. Each component is secured on the bone by a long, grooved stem that is anchored by acrylic cement. The grooves key the stem to the acrylic. When installed, a pin passes through the bearings and bearing block to form a hinge. Once the joint capsule heals, the pin is removed to reduce distraction stresses. This joint is, therefore, convertible between a constrained and unconstrained design.
U.S. Pat. No. 3,990,117 discloses an implantable elbow prosthetic joint with cemented stems that articulate in a simple hinged mechanism. Varus and valgus forces are accounted for by allowing “wobble” to avoid damaging the pin assembly, and to place these forces between the shoulders of the implant.
U.S. Pat. No. 3,991,425 discloses a prosthetic joint. The prosthetic joint includes ceramic components having mating concave and convex condylar surfaces. Intersecting lands are provided for stopping motion at the joint's extended and contracted positions. Each of the mating components also includes a stem for implantation in the appropriate medullary canals.
U.S. Pat. No. 4,008,495 discloses a prosthetic bone joint. This joint is designed for minimal bone removal. The humeral component is a pair of frustoconical shapes joined at their narrow ends, which is installed by wedging the component into the intracondylar notch. The ulnar component is made from polymer, and includes a convex bearing surface. The ulnar component is held in place by a bone screw as well as acrylic cement.
U.S. Pat. No. 4,057,858 discloses an elbow prosthesis. This prosthesis includes a humeral component defining a groove in the shape of the helix for mating with a concave surface of the ulnar component. The obliquity of the groove within the trochlea allows the ulnar implant to move into valgus during elbow extension and varus in flexion. A second groove may mate with a radial component. This prosthesis is therefore unconstrained. All components include stems that are secured to the bone by cement.
U.S. Pat. No. 4,079,469 discloses an elbow joint endoprosthesis. The humeral component defines a T-shaped channel for receiving an I shaped portion of the ulnar component. The humeral component includes short longitudinal and transverse keys for securing to the bone. The humeral component also includes a surface for bearing against a radial component. The humeral component is made from polymer, and the ulnar component is made from chrome cobalt. The joint allows minimal varus and valgus yet allows for flexion and extension motion.
U.S. Pat. No. 4,129,902 discloses an elbow prosthesis. The humeral component is connected to an ulnar component by a shaft on the humeral implant and a sleeve on the ulnar implant, providing for hinged articulation between these components. Both implants include tapered stems that are cemented into the bone. A radial implant includes a metal shaft that rotates within a polymer sleeve, and is connected to the humeral component by a chain.
U.S. Pat. No. 4,131,956 discloses an elbow prosthesis. The humeral component includes a U-shaped section holding a non-rotatable polyethylene head. The ulnar component includes a corresponding curved surface for forming an unconstrained joint. Both components include spikes that are cemented into the bone.
U.S. Pat. No. 4,224,695 discloses an endoprosthetic elbow joint. The joint provides a hinged connection between the humeral component, ulnar component, and radial component. The radial component permits rotation around the axis of the radius as well as around the hinge joint. No varus and valgus laxity is allowed between the humerus and ulna.
U.S. Pat. No. 4,242,758 discloses an elbow prosthesis. The humeral components are a tube shaped metal piece with three generally spherical surfaces. A very accurate reproduction of the distal humerus articular surface is provided. It can be used either with an ulnar or a radial replacement or in isolation in which it acts as a hemi-arthroplasty. The ulnar component includes a concave plastic bearing surface with a metal support. The radial component includes a metal pin with a plastic, concave bearing surface. The joint appears unconstrained.
U.S. Pat. No. 4,280,231 discloses an elbow prosthesis. The humeral component includes a pair of sides connected by a cylindrical cross member. The ulnar component has a hook for engaging the cylindrical cross member. Both components include stems for securing to the bones with acrylic cement. The humeral member also includes a surface for engaging the radius.
U.S. Pat. No. 4,293,963 discloses an unconstrained elbow prosthesis. The prosthesis includes a humeral component having an elongated stem and a substantially cylindrical, convex articulating surface. The ulnar component includes a metal retainer with a polyethylene bearing. The metal retainer includes an elongated stem depending from a metal base, and which is slightly curved. The bearing includes a concave cylindrical cavity for receiving the cylinder of the humeral component. A limited amount of medial-lateral motion in addition to flexion and extension is allowed.
U.S. Pat. No. 4,383,337 discloses an elbow prosthesis. The humeral member has a stem and a flange on either side for retaining a bushing as well as a spherical surface for engaging a radial member or a radius. The ulnar member has a stem, a concave surface, and a central projection ending in a cylinder. The projection fits within the bearing. The radial member includes a concave surface. This implant is intended to be a semi constrained joint. The patent claims that the joint is capable of handling up to 50 kg of force.
U.S. Pat. No. 4,538,306 discloses an elbow prosthesis having a humeral component consisting of a sleeve with a circumferential slot. A cylindrical sliding member fits inside the sleeve, abutted by the sides of a slot cut into the humerus. The shaft is inserted through the slot in the sleeve, and secured to the sliding member. The shaft is secured within a hole in the ulna. The shaft and sliding member can, therefore, pivot with respect to the sleeve, forming a hinge. The shaft includes ridges for better retention within the ulna.
U.S. Pat. No. 4,681,590 discloses a femoral stem prosthesis. The prosthesis includes an elongated stem portion, and a ball shaped head. The stem portion includes one or more elongated resilient spring strips which are acted upon by an adjustable screw to cause the spring strips to bow outwardly into engagement with the canal walls.
U.S. Pat. No. 4,840,633 discloses a cementless endoprosthesis. The prosthesis includes a stem that is tapered towards its distal end. A pair of windows are defined the proximal area of the stem. The endoprosthesis further includes a screw spindle having a broad flanged thread in the form of a helix. The thread projects from the windows on either side of the endoprosthesis. Turning the screw spindle causes the helical broad flanged thread to cut into the adjacent bone structure, thereby securing the implant in place. This endoprosthetic stem provides for a load transmission exclusively into the proximal portion of the bone, while the distal portion is free of axial loads.
U.S. Pat. No. 5,167,666 discloses an endoprosthesis for a femur. The endoprosthesis includes a stem that is hollow, slotted, flexible and intended to avoid placing pressure on the bone at this point. A collar and clamping cone are located at the upper end of the endoprosthesis. A tension anchor includes a screw that passes through the femur and is fastened to the prosthesis collar.
U.S. Pat. No. 5,314,484 discloses a biaxial elbow joint replacement. The joint replacement includes a hinge block having an ulnar pivot as well is a humerus pivot. Each pivot permits movement through about 90°. A spike is attached to each pivot for cementing within the respective bone. The design is intended to minimize the transfer of stresses from one component to the other.
U.S. Pat. No. 5,376,121 discloses a dual constraint elbow prosthesis. The prosthesis includes humeral and ulnar members consisting of a spike for insertion into the bone, and the yoke for connecting to a connecting link. The spikes are intended to be secured with cement. The pivot dimensions for the ulnar member are intended to permit a slight sideways rocking, while the humeral member is more constrained. The prosthesis permits 16° of varus and valgus laxity as well as 10° of rotational laxity between the humeral and ulnar components with the hope that this would decrease polyethylene wear. Pivotal rotation that decreases torque is described. By using two axes of rotation, this design reproduces the anterior translocation of the ulna during motion.
U.S. Pat. No. 5,458,654 discloses a screw fixed femoral component for a hip joint prosthesis. The prosthesis includes an intramedullary stem as well as a portion for receiving a ball head. The stem has lateral screw holes defined therein. The stem is secured to the bone by drilling holes into the bone corresponding to the screw holes in the stem, and then driving screws into these holes.
U.S. Pat. No. 5,667,510 discloses a system for fusing the middle and distal phalanx bones in the finger.
U.S. Pat. No. 5,723,015 discloses an elbow prosthesis. The prosthesis includes an ulnar component having a head for receiving the spindle of the humeral components. A ring-like clip retains the spindle within the head. Both components have stems that are cemented into the intramedullary canal. Some play is permitted between the spindle and the clip.
U.S. Pat. No. 5,782,923 discloses an endoprosthesis for an elbow joint. The endoprosthesis includes hingedly connected humeral and ulnar components, each of which having a shaft for engagement in the bone canal. The ulnar component includes a lateral flange having a socket for guiding a sliding member. A radial component has a head portion that is swingingly mounted in the sliding member, thereby providing ball and socket articulation. The radial portion is, therefore, both swingable and displaceable with respect to the ulnar portion. The stems for the humeral, ulnar and radial components are cemented.
U.S. Pat. No. 5,879,395 discloses a total elbow prosthesis. The prosthesis includes cooperating humeral and ulnar elements. A radial element is provided with a ball that fits within a concave surface defined within the humeral element.
U.S. Pat. No. 6,027,534 discloses a modular elbow. The elbow includes humeral and ulnar components having stems for implantation in the intramedullary canals of the respective bones, and body portions that are each designed to receive bearings. The humeral member includes a pair of arms with a pivot extending therebetween, upon which one of the bearings may be placed. The ulnar member includes a slot for receiving a bearing member. The elbow may be used in an unconstrained manner by placing a generally cylindrical bearing on the humeral portion and a bearing having a concave surface on the ulnar portion. Alternatively, the implant may be used in a constrained manner by using a single bearing connected to both the humeral and ulnar components. A similar device is disclosed in U.S. Pat. No. 6,290,725 and U.S. Pat. No. 6,699,290.
U.S. Pat. No. 6,126,691 discloses a bone prosthesis fixation device. The mechanism includes a main body for implantation within the canal of a bone. The main body includes an internal passageway, as well as a plurality of openings extending between the passageway and the exterior of the main body. A plurality of bone engaging members are reciprocally positioned within each opening. When a plunger is passed into the internal passageway, the bone engaging members are pushed outward, thereby engaging the bone and securing the prosthesis into the bone. A second embodiment also provides a prosthetic device implantable into skeletal bone and has an elaborate gear system that rotates screws that gain fixation into the intramedullary canal.
U.S. Pat. No. 6,162,253 discloses a total elbow arthroplasty system that is intended for use in dogs, but for which the patent also recites possible use in humans. The device includes a combined radio-ulnar component having stems for installation into the canals of both the radius and the ulna. A concave surface on this component mates with a convex surface on the humeral components.
U.S. Pat. No. 6,306,171 discloses a total elbow arthroplasty system that is intended primarily for use in dogs, but for which the patent also recites possible use in humans. The implant includes a radial component having an isometric ball component that fits within a corresponding humeral component to form an unconstrained joint.
U.S. Pat. No. 6,379,387 discloses an elbow prosthesis. The elbow prosthesis includes a humeral component having a substantially cylindrical articulating surface that is concave, with its narrowest portion near the center of the part that interacts with the ulnar component. An ulnar component includes a second articulating surface having a concave portion structured to articulate with the humeral component, and having a convex surface to correspond to the surface of the cylindrical articulating surface. Varus and valgus movement is, therefore, permitted while retaining contact between the humeral and ulnar articulating surfaces. The ulnar component further includes a locking element forming an additional articulating surface, so that the total articulating surface of the ulnar component can extend over more than 180° of the humeral articulating surface. The locking element may be omitted if the surgeon realizes that the tendons and ligaments of the joint are in good condition. A portion of the humeral component's articulating surface extends beyond the retaining arms and interfaces with a radial component. A similar elbow prosthesis is disclosed in U.S. Pat. No. 6,760,368.
U.S. Pat. No. 6,475,242 discloses a plastic joint assembly. The joint assembly includes a flexible U-shaped connector that is secured to adjacent bones by threaded connectors.
U.S. Pat. No. 6,514,288 discloses a prosthetic femoral stem with a strengthening rib.
U.S. Pat. No. 6,517,541 discloses an axial intramedullary screw for the ostia synthesis of long bones. The screw is used for connecting pieces of fractured bones. The screw includes two tips at opposing ends for interfacing with a screwdriver, and threads across the remainder of its length for cutting into the cortical bone of the medullary canal. The screw can be threaded into one portion of a bone fragment and then, after connecting another bone fragment at the fracture site, screwed in the opposite direction into the second fragment.
U.S. Pat. No. 6,716,248 discloses a prosthetic joint that may be utilized to form either a single axis joint or a double axis joint, permitting the surgeon to decide which type to construct from the kit once the elbow has been exposed during surgery. A similar device is disclosed in U.S. Pat. No. 6,997,957.
U.S. Pat. No. 6,890,357 discloses an elbow prosthesis similar to that of U.S. Pat. No. 6,379,387. The elbow prosthesis includes a humeral component having a substantially cylindrical articulating surface that is concave, with its narrowest portion near the center of the part that interacts with the ulnar component. An ulnar component includes a second articulating surface having a concave portion structured to articulate with the humeral component, and having a convex surface to correspond to the surface of the cylindrical articulating surface. Varus and valgus movement is, therefore, permitted while retaining contact between humeral and ulnar articulating surfaces. The ulnar component further includes a locking element forming an interconnection with an additional articulating surface, so that the total articulating surface of the ulnar component can extend 360°. The locking element may be omitted if the surgeon realizes that the tendons and ligaments of the joint are in good condition. A portion of the humeral component's articulating surface extends beyond the retaining arms, and interfaces with a radial component or native radial head.
U.S. Pat. No. 7,247,170 discloses an elbow prosthesis. The ulnar component includes a pair of concave spherical bearing surfaces that interface with a pair of convex spherical bearing surfaces on the humeral components. An axis passing through the ulnar component connects the two bearing surfaces of the humeral components. The spherically shaped bearing surfaces are intended to transmit load over a relatively large area rather than at a point or over a line of contact. The surgeon may employ a modular flange for compressing a bone graft, a tissue fastener for securing soft tissue to a portion of the prosthetic joint, a cam for limiting the amount by which the prosthetic joint articulates or a bearing insert for tailoring the degree of varus/valgus constraint.
U.S. Pat. No. 7,850,737 discloses a prosthetic elbow replacement. The elbow replacement includes a humeral component having a stem dimension to fit within a medullary canal of a humorous, as well as a J shaped flange for providing additional support of the implant with respect to the humerus. Both the stem and the J shaped flange include porous surface sections into which bone tissue can grow and/or bone cement can infiltrate. The humeral component also includes a yoke terminating in a pair of arms having a pivot connected therebetween. The pivot includes a through hole for use in attaching an ulnar component. The ulnar component also includes an ulnar stem having a porous surface portion. Varus and valgus motion is provided by movement of the ulnar component with respect to the through hole of the pivot.
US 2005/0049710 discloses a prosthesis for partial replacement of an articulating surface on bone. The surfaces that are to be replaced are for the coronoid and the radial head. The fixation of these partial prostheses is done with headless and regular screws.
US 2007/0185584 discloses a method and apparatus for digit joint arthroplasty. The method includes drilling and tapping the intramedullary canal, and then utilizing a threaded rod to secure the implants in place. The implant is intended to replace the articular surface of the bone with a similarly shaped metal surface, thereby avoiding the use of a hinge joint with a constant center of rotation, and maintaining the mechanical advantage of the flexor and extensor tendons in the same manner as the natural joint structure. Additionally, reproducing normal physiologic motion has the added benefit of limiting the stresses transmitted through the prosthesis to the stem-bone interface.
US 2010/0179661 discloses an elbow prosthesis. The ulnar component includes a pair of concave spherical bearing surfaces that interface with a pair of convex spherical bearing surfaces on the humeral components. An axis passing through the ulnar component connects the two bearing surfaces of the humeral component. The spherically shaped bearing surfaces are intended to transmit load over a relatively large area rather than at a point or over a line of contact. The prosthesis is provided in the form of a joint kit having a plurality of interchangeable bearing inserts which permit the surgeon to tailor the degree of varus/valgus constraint. Some examples can be linked together without fasteners or other hardware.
US 2012/0109322 discloses a prosthesis to replace at least a portion of a comminuted bone fracture. The prosthesis reproduces the articular surface of a comminuted distal humerus fracture in order to restore joint viability and articulation.
From the above description, it is clear that the vast majority of elbow prostheses are secured utilizing bone cement and, therefore, carry all of the inherent disadvantages of bone cement. Of the minority that are secured by screws, the hinge components of many of these implants must be turned along with the threaded shaft, preventing the hinge portion of the implant from being pulled precisely into the correct position and orientation within the bone. Furthermore, threaded attachments are subject to loosening if not further secured by some additional means. Accordingly, there is a need for a mechanical fastener that pivots with respect to the hinge component of the implant, thereby positioning the hinge portion in the correct position at whatever point the mechanical fastener reaches its maximum depth. There is a further need for a threaded or other mechanical attachment for securing implant components to bone that includes both a major loadbearing portion, and a secondary securing portion to ensure the stability of the major loadbearing portion.
Although it is often difficult for a surgeon to know whether a hemiarthroplasty or total arthroplasty will be required prior to commencing surgery, very few of the implants described above may be used for either type of surgery. Accordingly, there is a need for a prosthetic elbow that may be interchangeably used for hemiarthroplasty and total arthroplasty, permitting the surgeon to decide between the two operations mid-surgery.
Numerous methods have been proposed for permitting varus/valgus movements, thereby reducing stresses on the elbow prosthesis as well as the bones to which the prosthesis is attached. However, none of these methods has included any type of ligament reconstruction that would essentially reproduce that which was present in the elbow prior to injury or deterioration. Accordingly, there is a need for an elbow prosthesis that is installed in a manner that includes ligament reconstruction.
All mechanical devices are subject to wear. It is, therefore, helpful to have specific, easily replaceable components that are subject to wear in preference to other, more critical, and more difficult to replace components. Structures which are designed to wear in preference to other structures, and which are easily replaced during simple follow-up surgeries, are therefore needed.
The above needs are met by a prosthetic joint. One example of the prosthetic joint has a first component having a first intramedullary stem and a first connection portion. The first intramedullary stem is externally threaded and being pivotally secured to the first connection portion. The prosthetic joint further includes a second component having a second intramedullary stem and a second connection portion. The second intramedullary stem being externally threaded and being pivotally secured to the second connection portion. The second connection portion is structured to be movably secured to the first connection portion.
Another example of the prosthetic joint includes a first component having a first intramedullary bone securing portion and a first connection portion. The first connection portion is structured so that it can mate with a natural second bone end or a reconstructed second bone end without modification to the first connection portion.
Yet another example of the prosthetic joint includes a first joint component that is structured for attachment to a first bone. The first joint component being structured to secure a portion of a ligament reconstruction member. The prosthetic joint further includes a second joint component that is structured for attachment to a second bone. The second joint component is structured to secure a portion of a ligament reconstruction member.
A method of installing a prosthetic joint is also provided. One example of the method is carried out by first providing a prosthetic joint having first and second assemblies. The first assembly has a first threaded intramedullary securing member rotatably secured to a first connection portion. The second assembly has a second threaded intramedullary securing member rotatably secured to a second connection portion. The intramedullary canal of the first bone is broached, drilled, and tapped. The first threaded intramedullary securing member is installed into the intramedullary canal of the first bone. The first threaded intramedullary securing member is used to draw the first connection portion into the intramedullary canal of the first bone. The intramedullary canal of the second bone is broached, drilled, and tapped. The second threaded intramedullary securing member is installed into the intramedullary canal of the second bone. The second threaded intramedullary securing member is used to draw the second connection portion into the intramedullary canal of the second bone.
Another example of the method of installing a prosthetic joint between a first bone and a second bone begins by attaching a first joint component to the first bone. A second joint component is attached to the second bone. At least one tendon is removed. A portion of the tendon is secured to the first joint component. Another portion of the tendon is secured to the second joint component.
These and other aspects of the invention will become more apparent through the following description and drawings.
Like reference characters denote like elements throughout the drawings.
Referring to the drawings, an example of a prosthetic joint 10 is illustrated. As shown in
The humeral component 12 includes an intramedullary stem 16 that is rotatably and removably secured to a connection portion 18. The intramedullary stem 16 is structured for uncemented, mechanical securing within the intramedullary canal of the humorous. The illustrated example of the intramedullary stem 16 includes a threaded portion 20 disposed at one end, that is structured to engage a portion of the intramedullary canal that has been tapped with corresponding threads as described in greater detail below. The opposite end of the intramedullary stem 16 includes a head 22, which in the illustrated example has a slightly larger diameter than the immediately adjacent portion of the intramedullary stem 16. The tip 24 of the head 22 includes actuator engaging structures 26 that are structured to engage a rotatable actuation school. For example, the actuator engaging structures 26 could be a slot for a slotted screwdriver, a cross shaped slot for a Phillips head screwdriver, a hexagon shaped hole for an Allen wrench, a star shaped hole for a Torx screwdriver, or any other conventional actuator engaging structure.
Referring to
The distal ends 42, 44 of the legs 30, 32, respectively are structured to removably secure a spool 46 therebetween. In the illustrated example, openings 48, 50 are defined within the distal ends 42, 44 of the legs 30, 32. The holes 48, 50 are each structured to receive a fastener such as the illustrated screws 52 (
Referring to
Referring to
The connection portion 62 includes a base 72. The base 72 defines a channel 74 therein. The channel 74 includes a narrow portion 76 that is structured to receive the intramedullary stem 60, but not the head 66. A wider portion 78 of the channel 74 is structured to receive the head 66. The intramedullary stem 60 may therefore be placed within the channel 74, and rotatably secured therein, in a manner that prevents the head from passing into the narrow portion 76. The illustrated example includes a threaded hole 80 which, in the illustrated example, is coaxial with the channel 74, and whose purpose will be explained below.
The connection portion 72 further includes a bearing retention structure 82. The bearing retention structure 82 includes a concave, generally circular interior surface 84. A bearing retaining flange 86 is disposed at one and of the interior surface 84. The other end of the interior surface 84 terminates adjacent to the threaded hole 80. Referring specifically to
Referring to
Referring to
A method of installing the first joint component within the first bone (installing the humeral portion within the distal end of the humerus 126 in the illustrated example) is illustrated in
As shown in
Referring to
Once the connection portion 18 is firmly seated in place, as shown in
Referring to
An appropriately sized intramedullary stem 60 is paired with an appropriately sized base 72, as shown in
Once the prosthetic joint component 14 has been installed within the ulna, a bearing 104 is placed against the interior surface 84 of the base 72 (
Regardless of whether hemiarthroplasty or total arthroplasty is being performed, the illustrated example substantially mimics the movement and stability of a natural joint through a system of ligament reconstruction. Joint stability is defined as the resistance to subluxation under physiologic stress and is the result of the mechanical interaction of the articular contours, the dynamic support of the investing musclotendinous units, and the static viscoelastic constraint of the capsuloligatmentous structures. In order to be useful to the patient, the design of the prosthetic joint 10 must preserve this stability. Given that this design aims to replicate the native elbow bony anatomy and does not utilize a mechanical hinge to resist varus and valgus forces, the stability requirements are placed on the soft tissues.
Collateral ligaments are complex structures whose individual fascicles are under differential tension and whose properties depend on joint position and load. The collateral ligaments of the elbow, by virtue of their medial and lateral locations, have a mechanical advantage in resisting medially and laterally directed forces that would cause joint subluxation. In an effort to gain joint visualization during arthroplasty surgery, these ligaments are detached and then re-inserted once the implants have been placed. Reattachment is difficult to do particularly when the ligament integrity is compromised such as in the joints of elderly patients. Patients suffering from post-traumatic arthritis often sustained soft tissue as well as bony trauma making a subsequent collateral ligament repair more tenuous. Therefore, tendons taken from the patient or allograft tendons are utilized as ligament reconstruction members, as described below.
Initially, tendons are selected from the patient for use in reconstructing the ligaments. The specific tendon or tendon portion selected are chosen because its loss will have minimal or no impact on the patient. Tendons that may be advantageously utilized include a longitudinal strip of triceps tendon or the Palmaris Longus tendon. Alternatively, toe extensors or the Plantaris tendon or even half of the Flexor Carpi Radialis tendon can be used. Allograft tendon material may also be utilized.
With the appropriate ligament reconstruction members 154 obtained, the humeral joint portion 12 and ulna (in the case of hemiarthroplasty) or ulnar joint portion 14 (in the case of total arthroplasty) are placed against each other as shown in
The prosthetic joint described above provides numerous advantages over the prior art. The present design does not include cement fixation at all, and thereby eliminates the risk of bone cement implantation syndrome, as well as the other disadvantages of using bone cement. It is anticipated that, as the bones heal, they will grow into and/or around the various components of the prosthetic joint, thereby enhancing the security with which the prosthetic joint components are attached to the respective bones. Avoiding bone cement removes the exothermic curing process that may damage bone secondary to thermal osteonecrosis. In the event of infection, removal and replacement of prosthetic joint components is greatly simplified.
The attachment of the prosthetic joint components to the respective bones is particularly secure, and is anticipated to be able to withstand forces imparted to the biomechanical construct in excess of those which could be withstood by prior prosthetic joints. The use of relatively long intramedullary stems increases the surface area against which forces are applied, thereby reducing the pressure applied for an equivalent force. A screw that gains purchase in the threaded intra-medullary canal can pull the implant into the bone and create a very stable intra-medullary fixation based construct by distributing the forces over a sizeable number of threads. By leveraging the length of the humerus and ulna as well as the high cortical to cancellous bone ratio within the middle thirds of the humerus and ulna, the proposed method of fixation will make secure un-cemented implant fixation possible in a safe and reproducible manner. By distributing the forces over multiple threads, fixation through the intra-medullary screw is possible and reproducible even in bone that is fragile as is seen in osteoporotic patients. The use of interchangeable intramedullary stems and connection portions makes it possible to provide different length threaded rods that would not over-penetrate the far cortex beyond where it is achieving fixation. The use of cross locking members resists any tendency of the intramedullary stems to loosen over time.
The prior art method of constraining a total elbow arthroplasty resides in either using a hinge device in the implant (constrained) or repairing the ligaments after elbow replacement (unconstrained). No commercially available or previously marketed design attempts to provide stability through reconstruction of the elbow ligaments. Conversely, in the present design, the elbow is stabilized in a manner that most closely approximates how it functions in vivo. Secure ligament reconstruction is particularly advantageous as the patient populations that frequently receives this type of surgery often suffer from inflammatory arthritis and may not have a soft tissue envelope that can be relied on to provide stability when reattached after implantation. The use of autograft or allograft ligament reconstruction members provides a means of accommodating varus/valgus movement by transferring forces to the medial and lateral ligaments of the elbow similar to what is experienced in vivo.
The prosthetic joint described above further provides for simplified surgery. The surgeon need not decide between hemi arthroplasty and total arthroplasty prior to performing the surgery, and can instead make this intraoperative decision. An easily replaced bearing is designed to wear in preference to components that are more difficult to replace. When the bearing wears out, which is anticipated to be a period of years, a relatively simple surgery may be used to replace the bearing.
A variety of modifications to the above-described embodiments will be apparent to those skilled in the art from this disclosure. For example, other methods of attaching ligament reconstruction methods between the respective joint components could be utilized without departing from the scope of the invention. Additionally, other hinge joints, such as knees, fingers, etc., may be repaired using a prosthetic joint described herein. Additionally, a ball and socket joint such as a shoulder or hip would equally benefit from the cementless attachment methods taught herein, as well as variations of ligament reconstruction utilizing tendons from the patient to secure the mating joint components. Thus, the invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof. The particular embodiments disclosed are meant to be illustrative only and not limiting as to the scope of the invention. The appended claims, rather than to the foregoing specification, should be referenced to indicate the scope of the invention.
This application is a divisional of U.S. patent application Ser. No. 14/046,924, which was filed on Oct. 5, 2013, and entitled “Prosthesis for Partial and Total Joint Replacement.
| Number | Date | Country | |
|---|---|---|---|
| 20160158018 A1 | Jun 2016 | US |
| Number | Date | Country | |
|---|---|---|---|
| 61806392 | Mar 2013 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 14046924 | Oct 2013 | US |
| Child | 15018846 | US |
