Abstract:
A system is disclosed for repairing and reconstructing a joint which has been injured by trauma, and especially an acromioclavicular joint. Means are disclosed to strengthen the repair or reconstruction and to maintain alignment while the ligaments in the joint heal, thus allowing more aggressive rehabilitation. A new joint repair tool is disclosed which is inserted into two separated bones adjacent to their respective articular joint surfaces to connect the two bones and approximate the adjacent bearing articular joint surfaces while still allowing motion between the two bones. Instruments to perform the methods are also disclosed.

Description:
[0001]     This is a nonprovisional application which claims the filing date of the same applicant&#39;s provisional application Ser. No. 60/764,027 filed in the United States Patent and Trademark Office on Feb. 2, 2006. 
     
    
       [0002]     This invention relates to systems for repairing and reconstructing injured acromioclavicular (hereafter “AC”) joints. More particularly it relates to a novel joint repair tool and a related family of methods of orthopaedic surgery and instruments for repairing and reconstructing an injured acromioclavicular joint.  
         [0003]     Except for the provisional application just referred to, there are no patent applications related to this one. Neither this application nor the provisional application upon which it relies is subject to any federally sponsored research or development or to any joint research agreement.  
       BACKGROUND OF THE INVENTION  
       [0004]     Orthopaedic surgeons perform reparative or reconstructive surgery on joints which have been separated or dislocated by trauma. The goal of surgery is to properly align the adjacent bones of a joint and either repair or reconstruct the ligaments of the joint to maintain their position. With regard to the AC joint of the human shoulder ( FIG. 1 ), the clavicle and acromion of the scapula (two bones of the AC joint) can be separated by traumatic injury. With significant separation, two sets of ligaments are damaged, particularly the AC and coracoclavicular (CC) ligaments. After reparative or reconstructive surgery to realign the AC joint, it is difficult to oppose the distracting forces at the joint while the AC and CC ligaments, or reconstructed ligaments, heal. Often during the early postoperative period, because the repair or reconstruction is not sufficiently strong, the AC joint may lose its alignment and re-separate. Methods, instruments and an implant to assist and strengthen the repair or reconstruction may maintain the alignment of the AC joint better while the repaired or reconstructed ligaments heal, allow an earlier more aggressive rehabilitation and quicker return to activities, and improve the outcome after AC joint surgery.  
       BRIEF SUMMARY OF THE INVENTION  
       [0005]     The present invention discloses a new joint repair tool, and the methods and instruments associated with its use, in repairing and reconstructing injured and separated joints, including the AC joint.  
         [0006]     Accordingly, one object of this invention is to provide a means to strengthen the repair or reconstruction, to better maintain the alignment of the AC joint while the repaired or reconstructed ligaments heal, to allow an earlier more aggressive rehabilitation and quicker return to activities, and to improve the outcome after AC joint surgery.  
         [0007]     Another object of this invention is to provide a simple joint repair system to restore the proper alignment of two or more bones in a fashion that properly approximates the adjacent bearing articular joint surfaces while still allowing normal motion between the bones.  
         [0008]     Another object of this invention is to provide a new joint repair tool which is inserted into two separate bones adjacent to their respective bearing articular joint surfaces to connect the two bones in a fashion that properly approximates the adjacent bearing articular joint surfaces but still allows motion between the two bones.  
         [0009]     Another object of this invention is to provide a method and instruments to insert a new joint repair tool.  
         [0010]     Another object of this invention is to provide a drill sleeve to protect the skin and soft-tissue, to direct a drill bit and create a passageway in a first superficial bone, to direct a pin guide, and to direct a second drill bit.  
         [0011]     Another object of this invention is to provide a drill bit used to create a passageway in a first superficial bone.  
         [0012]     Another object of this invention is to provide a calibrated pin guide to protect the skin and soft-tissue, to direct a guide pin through or by the first superficial bone into a deep second, and to measure the distance of the path to the second deep bone from the first bone.  
         [0013]     Another object of this invention is to provide a guide wire to be placed into a second deep bone and to guide a cannulated drill bit into the second deep bone.  
         [0014]     Another object of this invention is to provide a cannulated drill bit to create a hole in a second deep bone.  
         [0015]     Another object of this invention is to provide a driver to insert a new joint repair tool into both the first and second bones.  
         [0016]     Another object of this invention is to provide a method to repair or reconstruct the AC and/or the CC ligaments after inserting a new joint repair tool.  
         [0017]     Another object of this invention is to provide a joint repair tool that may be used to treat other joints, including the ankle. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0018]      FIG. 1  is a perspective view of a shoulder with an uninjured acromioclavicular (AC) joint, acromioclavicular (AC) ligaments, and coracoclavicular (CC) ligaments.  
         [0019]      FIG. 2  is a perspective view of the shoulder in  FIG. 1  showing a separation of the AC joint, illustrating a separation of the bearing articular joint surfaces of the clavicle and the acromion process of the scapula and disruption of both the acromioclavicular (AC) and coracoclavicular (CC) ligaments.  
         [0020]      FIG. 3  is a perspective view of the novel joint repair tool of the present invention applied to the clavicle and coracoid process of the scapula in  FIG. 2  to restore the proper relationship between the adjacent bearing articular joint surfaces of the clavicle and the acromion process of the scapula of the AC joint in accordance with the present invention.  
         [0021]      FIG. 4  is a schematic view of the manner of positioning a patient with a fluoroscopy C-arm unit, or similar intraoperative radiographic device, for performing the surgical technique of the present invention.  
         [0022]      FIG. 5  is a schematic view of the manner of drilling a passageway in a first bone, the clavicle, in line with a second bone, the coracoid process of the scapula, in accordance with the present invention.  
         [0023]      FIG. 6  is a schematic view of the shoulder of  FIG. 5  showing the manner of inserting a guide pin through the passageway in the first bone, the clavicle, into the second bone, the coracoid process of the scapula, utilizing a drill sleeve and pin guide in accordance with the present invention.  
         [0024]      FIG. 7  is a schematic view of the shoulder of  FIG. 6  showing the manner of drilling a hole in the second bone, the coracoid process of the scapula, through a passageway in the first bone, the clavicle, over the guide pin in accordance with the present invention.  
         [0025]      FIG. 8  is a further perspective view of the joint repair tool of  FIG. 3 .  
         [0026]      FIG. 9  is a perspective view of a portion of a driver instrument for use with the joint repair tool of  FIGS. 3 and 8  in accordance with the present invention.  
         [0027]      FIG. 9A  is a perspective view of a portion of a driver instrument for use with the joint repair tool of  FIGS. 3 and 8  in accordance with the present invention.  
         [0028]      FIG. 9B  is a perspective view of portions of a driver instruments for use with the joint repair tool of  FIGS. 3 and 8  in accordance with the present invention.  
         [0029]      FIG. 10  is a schematic view of the manner of inserting the joint repair tool of  FIGS. 3 and 8  through the passageway in the first bone, the clavicle, into the second bone, the coracoid process of the scapula, over the guide pin using the driver of  FIG. 9  in accordance with the present invention.  
         [0030]      FIG. 11  is a perspective view of the joint repair tool of  FIGS. 3 and 8  applied to the clavicle and coracoid process of the scapula to restore the proper relationship between the adjacent bearing articular joint surfaces of the clavicle and acromion process of the scapula of the AC joint in  FIGS. 1 and 2  in accordance with the present invention.  
         [0031]      FIG. 12  is an enlarged view of an AC joint of a shoulder of  FIGS. 1 and 2  illustrating Step  1  of the manner of reconstructing the AC joint ligaments using a free soft-tissue graft along with the joint repair tool of  FIG. 3  in accordance with the present invention.  
         [0032]      FIG. 13  is an enlarged view of the shoulder portion of  FIG. 12  illustrating Step  2  of the manner of reconstructing the AC joint ligaments using the free soft-tissue graft along with the joint repair tool in accordance with the present invention.  
         [0033]      FIG. 14  is an enlarged view of the shoulder portion of  FIG. 12  illustrating Step  3  of the manner of reconstructing the AC joint ligaments using the free soft-tissue graft along with the joint repair tool in accordance with the present invention.  
         [0034]      FIG. 15  is an enlarged view of the shoulder portion of  FIG. 12  illustrating Step  4  of the manner of reconstructing the AC joint ligaments using the free soft-tissue graft along with the joint repair tool in accordance with the present invention.  
         [0035]      FIG. 16  is an enlarged view of the shoulder portion of  FIG. 12  illustrating Step  5  of the manner of reconstructing the AC joint ligaments using the free soft-tissue graft along with the joint repair tool in accordance with the present invention.  
         [0036]      FIG. 17  is an enlarged view of the shoulder portion of  FIG. 12  illustrating a manner of reconstructing the AC and CC joint ligaments using a free soft-tissue graft along with the joint repair tool of  FIG. 3  in accordance with the present invention.  
         [0037]      FIG. 18  is a schematic view of the shoulder of  FIGS. 1 and 2  illustrating an alternate manner of reconstructing the AC and CC joint ligaments using a free soft-tissue graft along with the joint repair tool of  FIG. 3  in accordance with the present invention.  
         [0038]      FIG. 19A  is a schematic view of an interference screw device being inserted into the second bone attachment component of the joint repair tool to secure the soft-tissue graft used to reconstruct the coracoclavicular ligaments  
         [0039]      FIG. 19B  is a schematic view of an interference screw device inserted into the second bone attachment component of the joint repair tool to secure the soft-tissue graft used to reconstruct the coracoclavicular ligaments  
         [0040]      FIG. 20  is a perspective view of the joint repair tool of  FIG. 3  applied to the fibula and tibia of an ankle joint to restore the proper relationship between adjacent bearing articular joint surfaces of the fibula, tibia and talus of the ankle joint in accordance with the present invention. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0041]     The present invention relates to the use of a novel joint repair tool and to methods and associated instruments for performing joint reparative and reconstructive surgery, including, particularly, the acromioclavicular joint  8  of a shoulder  1  (see  FIGS. 1, 2  and  3 ). The present invention includes novel techniques, a novel joint repair tool  10 , a driver  25  for the joint repair tool  10 , a drill sleeve  30 , a first drill bit  34 , a pin guide  40 , a guide pin  43 , a second drill bit  45  and a slotted graft passing pin  65 .  
         [0042]     Following a traumatic injury to the shoulder, the bearing articular surfaces  8 A and  8 B of the AC joint.  8  may be separated or dislocated by the disruption of the stabilizing acromioclavicular (AC) ligament  7  and the coracoclavicular (CC) ligament  6  (see  FIGS. 1 and 2 ). Depending upon the severity of the separation or dislocation, the clavicle bone  3  can become separated from the acromion process  4  of the scapula bone  2  of shoulder  1 . Surgery to repair or reconstruct the AC ligament  7  and CC ligament  6  may be required to realign clavicle bone  3  relative to the acromion process  4  of the scapula bone  2  and stabilize the bearing articular surfaces  8 A and  8 B of the AC joint  8 . AC joint repair or reconstructive surgery can be performed utilizing the joint repair tool  10 ,  FIGS. 3 and 8 , to improve the fixation strength and allow better healing of the native or reconstructed ligaments.  
         [0043]     AC joint reparative and reconstructive surgery can be performed with the patient in a semi-upright beachchair position with the intraoperative fluoroscopy  100  centered over the coracoid  5  of shoulder  1 , as shown in  FIG. 4 . Using the fluoroscopy  100 , the surgeon identifies clavicle bone  3 , acromion process  4  of scapula bone  2 , coracoid process  5  of scapula bone  2  and the separated bearing surfaces  8 A and  8 B of AC joint  8 . He creates a limited exposure through the skin and soft-tissue over the superficial aspect of the superficial bone, clavicle  3 , in line with the deep bone, the base of coracoid process  5  of scapula  2 .  
         [0044]     After exposing the superficial surface of the superficial bone, clavicle  3 , the surgeon uses drill sleeve  30  with first drill bit  34  to create passageway  9  through clavicle  3  as shown in  FIG. 5 . Drill sleeve  30  includes a handle  31 , a shaft  32  and a protective guide tip  33 . The protective guide tip  33  is a thin but rigid tube which directs first drill bit  34  while protecting the surrounding soft-tissue. The inner diameter of protective tip  33  corresponds to the outer diameter of first drill bit  34  such that the direction of first drill bit  34  is well-controlled by tip  33  and runs smoothly within it. The outer diameter of first drill bit  34  ranges up to 15 mm, and preferable is in the range of 4 mm to 6 mm.  
         [0045]     The surgeon uses intraoperative fluoroscopy  100  to assist in forming passageway  9  with the first drill bit  34 . Initially, protective guide tip  33  of drill sleeve  30  is centered over the superficial bone, clavicle  3 , in line with the deep bone, the base of the coracoid process  5  of scapula  2 . The first drill bit  34  is introduced into protective guide tip  33  and advanced through clavicle  3  aiming for the base of coracoid process  5  of scapula  2 . Simultaneously, the surgeon views the creation of passageway  9  with live fluoroscopy  100 .  
         [0046]     Once passageway  9  is created through clavicle  3 , the pin guide  40  is inserted into the clavicular passageway  9  upon the base of the coracoid process  5  of scapula  2  to assist in placing the guide pin  43  (see  FIG. 6 ). Preferably, although not necessarily, the pin guide  40  may be inserted through protective guide tip  33  of drill sleeve  30 .  
         [0047]     The pin guide  40  possesses a blunt pointed tip  44 , a long calibrated shaft  41 , a handle  42  and a longitudinal cannulation  46 . The blunt pointed tip  44  is designed to easily fit through the clavicular passageway  9  and to assist with proper placement of the guide pin  43 , using palpitation and fluoroscopic guidance  100 , upon the most superficial and central aspect of the bony crown of the base of the coracoid process  5  of scapula  2 . The long calibrated shaft  41  has two sets of calibrations, one referenced from the top of protective guide tip  33  and the other from the superficial surface of the superficial bone, clavicle  3 , in order to allow measurement of the length of the superficial bone clavicular passageway  9  and the remaining distance to the deep bone, the coracoid process  5  of scapula  2 .  
         [0048]     The outer diameter of shaft  41  of pin guide  40  is smaller than the outer diameter of first drill bit  34  and the inner diameter of clavicular passageway  9  in order to allow pin guide  40  sufficient freedom of movement within the passageway.  
         [0049]     With the pin guide  40  in proper position, guide pin  43  is drilled through central cannulation  46  of the pin guide  40  through the clavicular passageway  9  into the deep bone, the base of the coracoid process  5  of scapula  2 , under live fluoroscopy  100 . Then, with the guide pin  43  in proper position in the coracoid process  5  of scapula  2 , second drill bit  45  is run over guide pin  43  through clavicular passageway  9  to drill a hole in the coracoid process  5  of scapula  2  ( FIG. 7 ). Second drill bit  45  may be run through drill sleeve  30  in order to protect the surrounding soft-tissues. There is a central longitudinal cannulation  47  in second drill bit  45  to direct the bit over guide pin  43 . The outer diameter of second drill bit  45  is smaller than the outer diameter of first drill bit  34  and of the inner diameter of clavicular passageway  9  in order to allow second drill bit  45  sufficient freedom of movement within clavicular passageway  9 .  
         [0050]     Once the bones are exposed and prepared, the joint repair tool  10  may be inserted ( FIG. 8 ). Tool  10  is inserted into the two separate bones, the clavicle  3  and the scapula  2 , adjacent to their respective bearing articular joint surfaces  8 A and  8 B to connect the bones in a fashion which properly approximates the adjacent bearing articular joint surfaces  8 A and  8 B but still allows motion between the bones.  
         [0051]     The joint repair tool  10  is made of durable materials which are non-absorbable, bio-absorbable or capable of biointegration. Tool  10  possesses two bone attachment components, first bone attachment component  11  and second bone attachment component  13 , and a mobile intermediate component  12 . Components  11 ,  12  and  13  may be combined as a single fixed unit or made as separate components which may be disassembled and later assembled for use. The bone attachment components  11  and  13  possess geometry and surface properties which provide a purchase in or on the bones such as the coracoid process  5  of the scapula  2  and the clavicle  3 . Also, there are driver connection sites on the bone attachment components  11  and  13  which interface with a single driver  25  or separate drivers  25 A and  25 B to assist with insertion ( FIGS. 9, 9A , and  9 B). In form, the bone attachment components may be of similar or dissimilar design, varying according to their anatomic location for application, and they may attach to the bones by similar or dissimilar mechanisms.  
         [0052]     With the bone attachment components  11  and  13  connected to their respective bones, the mobile intermediate component  12  with its fixed or removable connections to the bone attachment components operatively engaged with those components  11  and  13  maintains clavicle  3  and scapula  2  and their adjacent bearing articular joint surfaces  8 A and  8 B in proper relationship while still allowing normal physiological motion of the bones and their joint surfaces.  
         [0053]     In one example (see  FIG. 8 ), the first bone attachment component  11  possesses threads and a leading tip which allows it to be drilled into scapula  2  or inserted into a hole in scapula  2 . The second bone attachment component  13  possesses a “top hat shape” with the “brim” acting as a stop  17  of broader dimension than the crown of the hat to capture clavicle  3  and maintain the relationship of clavicle  3  to scapula  2  by means of the mobile intermediate component  12  being connected to the first bone attachment component  11  in scapula  2 . In this example, mobile intermediate component  12  is a flexible wire or suture which allows the normal physiological motion between clavicle  3  and scapula  2  once the joint repair tool  10  is secured to those bones. The wire or suture of component  12  may be formed as a number of fixed loops or as loops with free ends which can be tensioned and secured after the first and second bone attachment components  11  and  13  are joined to scapula  2  and clavicle  3 . The loops may vary in length up to 100 mm, but are preferably in the range of 5 mm to 25 mm. Bone attachment components  11  and  13  are formed with a cannulation  14  which allows them to be inserted in clavicle  3  and scapula  2  over the guide wire  43 , if desired, although they may be inserted without using guide wire  43  if that is preferred.  
         [0054]     In this example, a single driver  25  can be used to insert the joint repair tool  10 , as shown in  FIGS. 9, 9A ,  9 B,  10 , and  11 . Driver  25  includes a handle  24 , a cannulation  29  for guide wire  43 , a shaft  27 , and two working segments, a first working  26  and a second working segment  28 , each with specific cross-sectional geometry (a hexagon, or a star, for example), which interface with the driver connection sites  15  and  16 , respectively, on the joint repair tool  10 . The shaft  27  of the driver may be of a fixed or adjustable length which matches the length of the mobile intermediate component  12  of the joint repair tool  10 . The joint repair tool  10  is loaded onto driver  25  by positioning the first working segment  26  through the second bone attachment component  13  and into the cannulation  14  of the first and second bone attachment components  11  and  13 . This loading step engages the first working segment  26  of driver  25  with driver connection site  15  of the first bone attachment component  11  and the second working segment  28  of driver  25  with driver connection site  16  of the second bone attachment component  13 . Because the driver  25  engages both bone attachment components  11  and  13  at the same time, the driver  25  can apply the joint repair tool  10  to and into both bones, the clavicle  3  and the scapula  2 , simultaneously, thus maintaining a constant spatial and connective relationship between the two bone attachment components  11  and  13  of tool  10  without twisting mobile intermediate component  12 .  
         [0055]     In this example, the proper length of the joint repair tool  10  is based upon previous measurements made by calibrated pin guide  40 . A properly sized joint repair tool  10  is inserted with the driver  25  through the superficial clavicular bone passageway  9  into the deep bone, coracoid process  5  of scapula  2 , over guide wire  43 . First bone attachment component  11  is advanced into the deep bone, coracoid process  5  of scapula  2 , until the second bone component  13  of tool  10  engages the superficial bone with its stop  17  and restores a proper relationship between the adjacent bearing articular surfaces  8 A and  8 B of the acromion process  4  of scapula  2  and clavicle  3  (see  FIGS. 10, 11 ). Guide wire  43 , if used, and driver  25  are then removed.  
         [0056]     Before or after inserting the joint repair tool  10 , resection arthroplasty of the bearing articular surfaces  8 A and  8 B of the AC joint  8  may be performed using conventional open or arthroscopic techniques for irreparable damage to those bearing articular surfaces  8 A and  8 B.  
         [0057]     With the joint repair tool  10  in position, primary repair of the acromioclavicular (AC) ligament  7 , as well as of the coraclavicular (CC) ligament  6 , can be performed (see  FIG. 2 ). Primary repair can be performed using conventional suture or suture anchor techniques to sew the ligaments together, and that repair can be augmented by using a second joint repair tool  10 , designed, as described above, for use in clavicle  3  and acromion process  4  of scapula  2  to help restore the proper relationship between adjacent bearing articular joint surfaces  8 A and  8 B.  
         [0058]     Alternatively, reconstruction of the AC joint using free soft-tissue autografts or allografts  70  can be used, as shown in  FIGS. 2, 12 ,  13 ,  14 ,  15 ,  16 ,  17  and  18 . To reconstruct the acromioclavicular ligaments, tunnels  61  and  62  are constructed, respectively, in clavicle. 3  and in the acromion process  4  of scapula  2 . After the tunnels  61  and  62  are drilled, a passing pin  65  with a sharp leading tip  67  and a slot  66  is installed which assists with passing a free graft  70  having attached sutures  71  across the bearing articular surfaces  8 A and  8 B of the AC joint  8  (see  FIGS. 12, 13 ,  14  and  15 ). With the free graft  70  in position at the AC joint, the ends with attached sutures  71  are tensioned and secured by tying or fastening the sutures, and/or, if preferred, inserting a conventional interference fixation device or screw in bone tunnel  61  along with the free ends of graft  70  as shown in  FIG. 16 .  
         [0059]     To reconstruct the coracoacromial (CC) ligaments, free graft  70  with sutures  71  may be passed around the base of the coracoid process  5  of scapula  2  and clavicle  3  and through second bone component  13  of the joint repair tool  10 , as in  FIGS. 17 and 18 . With free graft  70  in position at the CC joint, the ends with attached sutures  71  are tensioned and secured by tying or fastening the sutures. Additionally, a conventional interference fixation device or screw may be inserted into the second bone attachment component  13  adjacent the soft-tissue graft to assist in securing the CC ligament reconstruction (See  FIGS. 19A and 19B ).  
         [0060]     The joint repair tool  10 , with its associated methods and devices described above, can be utilized in different anatomic locations to perform joint repair and reconstruction by restoring the proper relationship between adjacent bearing articular surfaces such as  8 A and  8 B. For example, tool  10  may be used in repairing and reconstructing an ankle syndesmosis  80  as shown in  FIG. 20  by placing tool  10  across fibula  81  and into tibia  82 . The design and size of tool  10  and its associated devices will, of course, vary according to the size and dimensions of the injured joint and its bones.  
         [0061]     From all of the foregoing it will be evident that, although particular forms have been illustrated and described, nevertheless various modifications can be made without departing from the true spirit and scope of the invention. Accordingly, no limitations are intended by the foregoing description and the accompanying drawings, and the true spirit and scope of the invention are intended to be covered by the following claims.