US20050043805A1

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Publication number: US20050043805A1
Application number: US10/917,266
Authority: US
Inventors: Steven Chudik
Original assignee: Individual
Current assignee: Individual
Priority date: 2003-08-11
Filing date: 2004-08-11
Publication date: 2005-02-24
Also published as: US20070027477A1; US20120041563A1; WO2005016123A2; US8540737B2; US20070005074A1; US20070100353A1; US20070016304A1; US9968459B2; WO2005016123A3; US20070027417A1; US9445910B2; US9974658B2; US20070016305A1

Abstract

The present invention provides a method and devices for shoulder replacement surgery that spares the rotator cuff. The method utilizes two anterosuperior passages to gain access to the glenohumeral joint, neither of which requires transaction of the rotator cuff. In addition a transhumeral portal created through the second anterosuperior passage for use as a working tunnel. Specialized instruments and implants are provided to work through both the anterosuperior passage as well as the transhumeral portal.

Description

Applicant claims, under 35 U.S.C §119(e), the benefit of priority of: 1) the filing date of Aug. 11, 2003 of U.S. Provisional Application No. 60/494,289, 2) the filing date of Oct. 8, 2003 of U.S. Provisional Application No. 60/509,655, 3) the filing date of Oct. 16, 2003 of U.S. Provisional Application No. 60/511,805, 4) the filing date of Nov. 19, 2003 of U.S. Provisional Application No. 60/523,401, 5) the filing date of Jun. 15, 2004 of U.S. Provisional Application No. 60/579,893 and 6) the filing date of Jul. 2, 2004 of U.S. Provisional Application No. 60/585,033, the entire contents of each of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to methods, instrumentation, and implants for orthopaedic surgery and, more specifically, to rotator cuff sparing procedures and associated devices for shoulder replacement surgery.

2. Discussion of Related Art

Orthopaedic surgeons perform joint replacement surgery for patients who suffer pain and physical limitations caused by joint surfaces that have been damaged by degenerative, traumatic, or other pathologic processes. The functional outcome from these joint replacement surgeries is directly related to the degree of morbidity associated with the surgical method and the ability of the method to best restore the natural anatomy and biomechanics of the joint. Orthopaedic surgeons are continually searching for ways to improve outcomes for joint replacement surgery by developing methods of less invasive surgery to limit surgical morbidity and by developing novel methods and implants to better restore the native joint anatomy.

Conventional shoulder replacement surgery has several limitations. It requires an extensive exposure that irreversibly damages the rotator cuff and still fails to gain sufficient joint access to properly restore the native anatomic relationships of both the humeral head and glenoid surfaces. Also, there remain issues with glenoid implant fixation and early loosening.

Conventional methods utilize a large anterior deltopectoral exposure. The anterior humeral circumflex blood vessels are typically ligated and the anterior (subscapularis) musculotendinous unit is transected. The shoulder must then completely dislocated both anteriorly and posteriorly to prepare the humeral and glenoid joint surfaces. This can cause excessive traction on the arm which has resulted in injury to the nerves of the brachial plexus (Lynch N M, Cofield R H, Silbert P L, et al. Neurologic complications after total shoulder arthroplasty. J Shoulder Elbow Surg 1996;5(1):53-61.).

With regards to shoulder replacement surgery, all conventional methods require surgical transection of a rotator cuff tendon to gain sufficient exposure of the joint surfaces of the shoulder (See U.S. Pat. No. 4,550,450, entitled, “Total Shoulder Prosthesis System”, the entire contents of which are incorporated herein by reference). After the joint surfaces are replaced, the rotator cuff tendon must be surgically repaired with suture material. This tenuous repair necessitates an obligatory period of approximately six weeks for the rotator cuff tendon to heal before advanced shoulder rehabilitation can be performed. This surgical transection and subsequent repair, as well as the delay in rehabilitation, hold significant consequences for the functional outcome of the shoulder replacement including permanent weakness and decreased range of motion (Miller SL et al., “Loss of subscapularis function after total shoulder replacement: A seldom recognized problem”, J Shoulder Elbow Surg. 2003 Jan-Feb;12(1):29-34).

Additionally, despite the extensive exposure, conventional methods for shoulder replacement surgery still fail to properly restore the native anatomic relationships of the joint surfaces of the shoulder. Conventional methods prepare the humeral surfaces of the shoulder joint by referencing off the intramedullary axis of the humeral shaft. This poses great difficulty for the surgeon since the intramedullary axis has an inconsistent relationship to the humeral surface. The humeral joint surface also possesses a complex anatomy with significant variability which cannot be entirely restored with conventional methods and implants. There exists much variability in the humeral head neck-shaft angle, posterior and medial offset, version (rotation), height, thickness, and radius of curvature. (Boileau P, Walch G, “The Three-Dimensional Geometry of the Proximal humerus”, J Bone Joint Surg Br 1997; 79B: 857-865; Iannotti JP, et al. “The Normal Glenohumeral Relationships. An Anatomic Study of One Hundred and Forty Shoulders”, J Bone Joint Surg 1992; 74A(4):491-500; McPherson E J, et al. “Anthropometric Study of Normal Glenohumeral Relationships”, J Shoulder Elbow Surg 1997;6:105-112; Soslowsky L J, et al. “Articular geometry of the glenohumeral joint”, Clin Orthop 1992;285:181-190). The failure to restore the native anatomic relationships and biomechanics to the shoulder joint has proven to result in a significantly lesser functional and durable outcome (Williams G R, et al. “The effect of articular malposition and shoulder arthroplasty on glenohumeral translations, range of motion, and subacromial impingement”, J Shoulder Elbow Surg. 2001; 10(5):399-409).

Conventional methods of shoulder replacement surgery also have difficulty gaining access to the glenoid joint surface. The glenoid surface of the shoulder joint is best prepared by working along an axis perpendicular to its surface. Because the humeral head sits in the way, this is a nearly impossible task with conventional methods. The humeral head has to be partially removed, the subscapularis (anterior shoulder rotator cuff muscle) transected, and the proximal humerus dislocated to even get close to working along this axis. Because of this difficulty, a majority of orthopaedic surgeons still choose not to replace the glenoid surface despite clinically proven results of improved pain relief and function for shoulder replacement surgery when both the humeral and glenoid surfaces are replaced. (Boyd A D, Thomas W H, Scott R D, et al. “Total shoulder arthoplasty versus hemiarthroplasty-indications for glenoid resurfacing”, J of Arthroplasty 1990;5(4):329-336; Gartsman G M, Roddey T S, Hammerman S M. J Bone Joint Surg 2000;82A(1):26-34; Edwards T B, Kadakia N R, Boulahia A, et al., “A comparison of hemiarthoplasty and total shoulder arthroplasty in the treatment of primary glenohumeral osteoarthritis: Results of a multicenter study”, J Shoulder Elbow Surg 2003; 12(3):207-13; Orfaly R M, Rockwood Calif., Esenyel C Z, et al., “A prospective functional outcome study of shoulder arthoplasty for osteoarthritis with an intact rotator cuff”, J Shoulder Elbow Surg 2003;12(3):214-21.)

Despite improved results of conventional methods when both the humerus and glenoid surfaces are replaced, there still remains limitations with regard to glenoid fixation and early glenoid implant loosening (Boileau P, Avidor C, Krishnan S G, et al., “Cemented polyethylene versus uncemented metal-backed glenoid components in total shoulder arthroplasty: a prospective, double-blind, randomized study”, J Shoulder Elbow Surg 2002;11(4):351-9.). Both, cemented polyethylene and metal backed glenoid components are used in conventional methods. The cemented implant never incorporates with the glenoid bone and with time, the cement-bone interface eventually fails and the implant comes loose. Conversely, the metal-backed glenoid prosthesis has an unacceptable rate of early loosening, at least 20% in one study. However, if the metal-backed implant can remain rigidly fixed to the bone for a sufficient period of time, the bone of the glenoid will eventually adhere to the metal-backed surface and long-term studies have revealed little evidence for late clinical loosening in these cases. Failure of the metal-backed glenoid implant appears to be related to the limitations in achieving sufficiently rigid and durable initial fixation

While performing shoulder replacement surgery for arthritis, associated rotator cuff tears are sometimes discovered and should be repaired when possible. If a less invasive surgical approach is employed to perform the shoulder replacement surgery, a less invasive method of rotator cuff repair that is compatible with the method shoulder replacement surgery must be to be available to simultaneously address these associated rotator cuff tears.

BRIEF SUMMARY OF THE INVENTION

One aspect of the present invention regards a method for shoulder replacement surgery. Utilizing the method of the present invention, a portal is created along a central axis of a neck of a proximal humerus that is associated with a shoulder of a patient. An implant is subsequently implanted into the shoulder of the patient, however a component of that implant is not passed through the portal. The rotator cuff is spared in the process.

One advantage provided by the above mentioned aspect of the present invention is that it allows determination of a central axis in the proximal humerus which allows simple and less invasive perpendicular access to the humeral and glenoid joint surfaces. An additional advantage is it offers a simple and reliable means of restoring the native anatomy and biomechanical relationships, allowing for an improved functional and durable outcome.

A further advantage is that it spares the rotator cuff tendons and allows for a quicker and more functional recovery

Another aspect of the present invention regards a humeral implant with one component that is removably attached to a second component.

Another aspect of the present invention provides a glenoid implant. The glenoid implant includes an ingrowth shell, a wear-resistant surface that is removably attached to the ingrowth shell. An advantage is that the ingrowth shell provides novel geometry and superior fixation to the glenoid.

An additional aspect of the invention regards a transhumeral portal sleeve with a bullet shaped guide that has a central and a peripheral longitudinal cannulation. An advantage is that it safely creates a working portal along the central axis of the proximal humerus.

In another aspect of the present invention, there is provided a transhumeral humeral reamer that has a working head and a removably attached transhumeral shaft with a diameter of from 0.1 to 5 cm.

Another aspect of the present invention regards a transhumeral glenoid reamer with a working head and a removably attached transhumeral shaft that has a diameter of from 0.1 to 5 cm.

In another aspect, a transhumeral protective sheath is provided that is a tube of material with a diameter of from 0.1 to 5 cm.

Another aspect of the invention regards a glenoid surface protective guard that has a protective surface and a removably attached handle.

In another aspect, a humeral head surface protective guard is provided that has a protective surface and a removably attached handle.

An additional aspect of the invention regards a glenoid sizer and centering hole guide that has a surface that contacts the glenoid of a shoulder and a removably attached handle.

In another aspect, a drill guide with a guiding surface and a removably attached handle is provided. The guiding surface has a centering hole and is available in sizes equivalent to the respective glenoid implants.

In another aspect, the invention regards a transhumeral glenoid drill with a working surface and a removably attached shaft.

In another aspect, a transhumeral burr is provided. The transhumeral burr has a high speed working burr surface and a removably attached shaft.

An additional aspect of the invention regards a glenoid keel punch with a working head and a removably attached shaft. The working head has a keel shape and cutting teeth.

In another aspect, a transhumeral irrigation and suction catheter is provided. The catheter is a semi-rigid plastic tubing removably attached to either a fluid pump or a suction device.

In another aspect, a transhumeral cementation device is provided that has a semi-rigid catheter removably attached to a head.

An additional aspect provides a transhumeral glenoid impactor with a dome-shaped head and a removably attached shaft.

Another aspect of the invention regards a transhumeral screw driver with a working head and a removably attached shaft.

In another aspect, the present invention provides a rotator interval retractor with a first blade dimensioned to interact with a supraspinatus and a second blade dimensioned to interact with a subscapularis.

Another aspect of the invention regards a glenohumeral joint with a transhumeral portal along a central axis of a neck of a proximal humerus as well as an implant.

Further advantages as well as details of the present invention ensue from the following description of a preferred embodiment represented in the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic of a patient positioned with fluoroscopy C-arm unit that may be used in conjunction with the present inventions;

FIGS. 2aandbare plan views of an embodiment of a rotator interval retractor with specialized supraspinatus and subscapularis blades (FIG. 2b) in accordance with the present invention;

FIG. 3ais a perspective view of an embodiment of a transhumeral portal drill guide and protective sleeve in accordance with the present invention.

FIG. 3bis a top plan view of the transhumeral portal drill guide ofFIG. 3a;

FIG. 3cis a side plan view of the protective sleeve of the transhumeral portal drill guide and sleeve ofFIG. 3ain accordance with the present invention;

FIG. 4ais a schematic of an embodiment of an insertion procedure of a proximal humeral guide pin and measurement of humeral head depth after placement of a second guide pin in accordance with the present invention;

FIG. 4bis a schematic of the insertion ofFIG. 4ausing an optional embodiment of a radiolucent guide attachment to assist with a guide pin insertion procedure in accordance with the present invention;

FIG. 5 is a schematic of an embodiment of a drilling procedure for forming an embodiment of a transhumeral portal in accordance with the present invention;

FIG. 6 is a schematic of a preliminary cut of a humeral head joint surface during an embodiment of a surgical procedure in accordance with the present invention;

FIG. 7ais a schematic showing a possible way of preparing the humeral head with a transhumeral humeral head reamer in preparation for a conventional proximal humeral implant during an embodiment of a surgical procedure in accordance with the present invention;

FIG. 7bis a schematic showing a possible way of preparing the humeral head with a novel transhumeral humeral reamer in preparation for a novel proximal humeral implant during an embodiment of a surgical procedure in accordance with the present invention;

FIG. 7cis a perspective view of an embodiment of a novel transhumeral humeral reamer head to be used in an embodiment of a surgical technique in accordance with the present invention;

FIG. 7dis a perspective view of an embodiment of a glenoid protective cap to be used in an embodiment of a surgical technique in accordance with the present invention;

FIG. 8ais a schematic showing a possible way of drilling a glenoid centering hole and placing a transhumeral glenoid guide wire with a glenoid sizing and centering guide which can be used for both a left and a right shoulder for a conventional proximal humeral implant in an embodiment of a surgical procedure in accordance with the present invention;

FIG. 8bis a schematic showing a possible way of drilling a glenoid centering hole and placing a transhumeral glenoid guide wire with a glenoid sizing and centering guide which can be used for both a right and a left shoulder for a novel proximal humeral implant during an embodiment of a surgical procedure in accordance with the present invention;

FIG. 8cis a perspective view of an embodiment of a head of a glenoid sizing and centering guide in accordance with the present invention;

FIG. 9ais a schematic of a way of preparing a glenoid with a cannulated transhumeral glenoid reamer for conventional proximal humeral implant during an embodiment of a surgical technique in accordance with the present invention;

FIG. 9bis a schematic of a way of preparing a glenoid with a cannulated transhumeral glenoid reamer for a novel proximal humeral implant during an embodiment of a surgical technique in accordance with the present invention;

FIG. 10ais a schematic of a way of preparing a glenoid with a transhumeral glenoid keel/peg drill and a glenoid peg or keel guide for a conventional proximal humeral implant during an embodiment of a surgical technique in accordance with the present invention;

FIG. 10bis a perspective view of a peg or keel guide for a conventional glenoid implant to be used in an embodiment of a surgical technique in accordance with the present invention;

FIG. 10cis a schematic of a way of preparing a glenoid with a transhumeral keel/peg glenoid drill and a glenoid peg or keel guide for a novel proximal humeral implant during an embodiment of a surgical technique in accordance with the present invention;

FIG. 11ais a schematic of a way of preparing a glenoid to accept a conventional keel glenoid implant with a transhumeral burr for a conventional proximal humeral implant during an embodiment of a surgical technique in accordance with the present invention;

FIG. 11bis a schematic of a way of preparing a glenoid to accept a conventional keel glenoid implant with a transhumeral burr for a novel proximal humeral implant during an embodiment of a surgical technique in accordance with the present invention;

FIG. 12ais a schematic of a way of preparing a glenoid to accept a conventional keel glenoid implant with a transhumeral keel punch for a conventional proximal humeral implant to be used in an embodiment of a surgical procedure in accordance with the present invention;

FIG. 12bis a schematic of a way of preparing a glenoid to accept a conventional keel glenoid implant with a transhumeral keel punch for a novel proximal humeral implant to be used in an embodiment of a surgical technique in accordance with the present invention;

FIG. 13ais a schematic a way of utilizing an embodiment of a transhumeral cementation catheter and glenoid cement pressurizer for a conventional proximal humeral implant to be used during a surgical procedure in accordance with the present invention;

FIG. 13bis a perspective view of an embodiment of a modular glenoid cement pressurizer tip for a keel implant and a catheter in accordance with the procedure shown inFIG. 13a;

FIG. 13cis an exploded view of an embodiment of a glenoid cement pressurizer tip ofFIGS. 13aandbin accordance with the present invention;

FIG. 13dis an exploded view of an embodiment of a glenoid cement pressurizer tip for a peg implant ofFIGS. 13aandc, in accordance with the present invention;

FIG. 13eis a schematic of a way of utilizing an embodiment of a transhumeral cementation catheter and glenoid cement pressurizer for a novel proximal humeral implant to be used during a surgical procedure in accordance with the present invention;

FIG. 14aa schematic of a way of utilizing an embodiment of a transhumeral glenoid impactor for a conventional humeral implant during a surgical procedure of the present invention;

FIG. 14bis a schematic of a way of utilizing an embodiment of a transhumeral glenoid impactor for a novel humeral implant during a surgical procedure of the present invention;

FIG. 15ais a exploded view of humeral implant in accordance with the present invention;

FIG. 15bis a bottom plan view of a humeral implant in accordance with the present invention;

FIG. 16 is a schematic of an embodiment of a humeral surface implant, Example A, in accordance with the present invention;

FIG. 17ais schematic of an embodiment of a humeral surface implant, Example B, in accordance with the present invention;

FIG. 17bis a perspective view of an embodiment of a stem with inner cement channels in accordance with the present invention;

FIG. 17cis an perspective view of an embodiment of a endcap of the novel transhumeral stem ofFIG. 17bin accordance with the present invention;

FIG. 18ais a schematic of a way of removing an embodiment of a humeral surface implant, Step1, Example B, during an embodiment of a surgical procedure in accordance with the present invention;

FIG. 18bis a schematic of a way of performingStep2 of removing an embodiment of a humeral surface implant ofFIG. 18aduring an embodiment of a surgical procedure in accordance with the present invention;

FIG. 19ais a schematic of inserting an embodiment of a humeral surface implant, Example C in accordance with the present invention;

FIG. 19bis a perspective view of a stem of an embodiment of a humeral implant ofFIG. 19athat is inflatable in accordance with the present invention;

FIG. 20ais a schematic a way of inserting a multiple peg glenoid surface to be used in an embodiment of a surgical technique in accordance with the present invention;

FIG. 20bis a side plan view of a glenoid peg to be used in during a surgical technique in accordance with the present invention;

FIG. 20cis a perspective view of a multiple peg glenoid guide ofFIG. 20ain accordance with the present invention;

FIG. 21 is a side perspective view of an embodiment of a novel transhumeral glenoid reamer in accordance with the present invention;

FIG. 22 is a schematic of a way of utilizing a novel glenoid reamer in an embodiment of a surgical technique in accordance with the present invention;

FIG. 23ais a perspective view of an embodiment of a shell component of a novel glenoid implant in accordance with the present invention;

FIG. 23bis a bottom plan view of a shell component of a novel glenoid implant ofFIG. 23a;

FIG. 24ais a schematic of a way of drilling screw holes into a glenoid utilizing a glenoid drill guide sleeve and glenoid screw guide sleeve in an embodiment of a surgical technique of the present invention;

FIG. 24bis an exploded view of the glenoid drill guide sleeve interfit with the glenoid screw guide sleeve ofFIG. 24a;

FIG. 25ais a schematic of a way of utilizing a glenoid screw guide sleeve and transhumeral screwdriver in accordance with an embodiment of a surgical technique of the present invention;

FIG. 25bis an exploded view of the glenoid screw guide sleeve ofFIG. 25a;

FIG. 26ais a schematic of utilizing a transhumeral impactor to secure a novel wear-resistant glenoid surface into an ingrowth shell of the novel glenoid implant in accordance with an embodiment of the present invention;

FIG. 26bis an exploded view of the novel glenoid implant ofFIG. 26a;

FIG. 27ais a side view of an embodiment of a novel glenoid implant in accordance with the present invention;

FIG. 27bis a top plan view of an embodiment of a novel wear-resistant surface the novel glenoid implant ofFIG. 27a;

FIG. 27cis a bottom plan view of an embodiment of the novel wear-resistant surface of novel glenoid implant ofFIGS. 27aandb.

FIG. 28ais a perspective view of an embodiment of an insertional guide in accordance with the present invention;

FIG. 28bis a perspective view of an embodiment of a flexible inner trocar of an embodiment of an insertion guide in accordance with the present invention;

FIG. 29 is a perspective view of an embodiment of a suture pin of the present invention;

FIG. 30 is a schematic of a way of performing an embodiment of a surgical technique using the insertion guide ofFIGS. 28-29 to bore into a greater tuberosity of proximal humerus in accordance with the present invention;

FIG. 31 is a schematic of a way of performing an embodiment of a surgical technique using the insertion guide ofFIGS. 28-29 to advance the suture-pin device through the greater tuberosity of the proximal humerus and leading edge of rotator cuff tendon in accordance with the present invention;

FIG. 32 is a schematic of a way of performing an embodiment of a surgical technique using a pin director to guide the pin out from the shoulder in accordance with the present invention

FIG. 33 is a schematic of a way of performing an embodiment of a surgical technique and tying the passed suture of the suture pin device after removing the pin component in accordance with the present invention.

DETAILED DESCRIPTION OF THE DRAWINGS AND THE PRESENTLY PREFERRED EMBODIMENTS

The present invention relates to methods, instrumentation, and implants for performing rotator cuff sparing shoulder replacement surgery. Both, total shoulder arthroplasty, where both the humeral and glenoid joint surfaces are replaced, and shoulder hemiarthroplasty, where only the humeral joint surface is replaced, can be performed as indicated. The present invention utilizes among other things: a novel surgical exposure including an optional method of arthroscopic anterior contracture release, posterior capsular tightening, osteophyte resection, and glenoid soft-tissue clearance; two limited incisions, a transhumeral portal and a deep rotator cuff sparing exposure; novel transhumeral instrumentation with modular working components, protective guides, sleeves, sheaths, and retractors; conventional or novel implants, and an associated method of rotator cuff repair.

Utilizing the method of the present invention, a portal is created along a central axis of a neck of a proximal humerus that is associated with a shoulder of a patient. This portal provides superior perpendicular access to both the humeral and glenoid joint surfaces in a less invasive manner to allow more anatomic replacement surgery to occur. The axis of the humeral head and the axis of the glenoid have a sufficiently consistent natural relationship such that simple positioning of the arm can allow a surgeon to easily align the central axis perpendicular to the humeral head with the axis perpendicular to the glenoid. Research has shown that there exists a natural relationship between the orientation of the humeral and glenoid surfaces (De Wilde, L F, et al., “Glenohumeral Relationship in the Transverse Plane of the Body”, J Shoulder Elbow Surg 2003;12(3):260-267). Therefore, I have determined that with consistent positioning of the arm, these axes will be co-linear.

Accordingly, the present invention provides a reliable way of reestablishing the proper orientation of the humeral and glenoid joint surfaces without the associated surgical morbidity of conventional methods, i.e., a large exposure, dislocation of the humerus, or transection of the rotator cuff, as will be described below. Note that in the description to follow there will be mention made of transhumeral instruments. Such transhumeral instruments include transhumeral proximal humerus and glenoid reamers, drills, burrs, guides, protective guards, sheaths, sleeves, cementation tools, glenoid peg and keel punches, and glenoid implant insertor and impactor.

Shown inFIGS. 4a-b,5,6,7a-b,8a-b,9a-b,10a-c,11a-b,12a-b,13a,13e,14a-b,16,17a,18a-b,19a,20a,22,24a,25a, and26a, is a possible medical procedure according to the present invention. Preoperatively, two orthogonal radiographic images should be taken including a Grashey anteroposterior view with the patient's shoulder held in neutral rotation to slight external rotation and an axiliary lateral view. Next, two-dimensional transparencies with representations of different sizes of the humeral and glenoid implants/templates are placed over the x-rays to evaluate the patients bony anatomy and estimate the size of the implants to be used. From these radiographic images, preoperative measurements can be taken of the humeral head diameter and depth, the humeral neck angle, glenoid size and version, and the amount of scapular bone available to fix the implants to be used in the surgical procedure. A preoperative CT scan of the shoulder can also be useful when plain radiographs do not offer sufficient detail.

After interscalene regional block and general anesthesia are administered by the anesthesiologist, the patient1 is positioned in a sitting position with abeach chair postioner3 as shown inFIG. 1. Prior to prepping and draping the patient1, a fluoroscopic C-arm machine7 is positioned accordingly to the patient1 to obtain a Grashey anteroposterior radiographic view and a modified axiliary lateral view using rotation of the shoulder and slight repositioning of thefluoroscopic machine7. After the fluoroscopic views are confirmed, thefluoroscopic machine7 is backed away from the patient1 and the shoulder and upper extremity are prepped and draped in sterile fashion.

Initially, an optional arthroscopic procedure may be performed using conventional arthroscopic tools to release the anterior capsular contractures, tighten the posterior capsule, resect osteophytes, and clear the glenoid soft-tissue for exposure. The procedure is begun by placing an arthroscope in the shoulder joint through a standard posterior portal and making an anterior rotator interval passage under needle localization. Standard diagnostic arthroscopy is performed and the posterosuperior, superior, and anterior labrum are excised or ablated; the biceps tendon may be released from the superior glenoid; and the anterior and anteroinferior ligamentous and capsular attachments are released from the glenoid. Then an accessory posterior passage is made under needle localization and an arthroscopic burr is inserted to remove the inferior humeral neck osteophytes. From the same accessory posterior passage, the posterior, posteroinferior and inferior labrum are excised or ablated and the posteroinferior and inferior ligamentous and capsular attachments to the glenoid are released from 7 O'clock anteriorly on a right shoulder or 5 O'clock anteriorly on a left shoulder. Gentle manipulation of the shoulder can also be performed if necessary to complete the soft-tissue release. Any posterior capsular redundancy can be addressed by techniques of capsular plication (tightening with arthroscopic sutures).

After the optional arthroscopic procedure is performed, an anterosuperior passage is formed to expose the glenohumeral joint. In particular, an anterosuperior incision is made either obliquely running over the anterolateral border of the acromion over the tip of the coracoid or longitudinally from just inferior to the clavicle running between the coracoid and the AC joint distally. Deep dissection is continued through the deltopectoral interval or a limited muscular split running in line with the deltoid muscle fibers. The clavipectoral fascia is incised, the coracoacromial ligament is released from the coracoid, and the subdeltoid and subacromial adhesions are released. Bony and soft-tissue subacromial decompression and distal clavicle excision should be performed if secondary conditions of impingement, rotator cuff tears, or acromioclavicular joint arthritis are present. The anterior circumflex blood vessels are ligated only as needed. The rotator interval is opened completely around both sides of the coracoid and distally into the biceps sheath. The supraspinatus and subscapularis muscles are bluntly released from the glenoid superior and anterior surfaces, respectively. A biceps tenodesis may be performed by simply sewing it to the tissue of the biceps sheath and excising the intraarticular portion of the tendon. At this point, a novelrotator interval retractor5 withspecialized supraspinatus2 andsubscapularis4 blades is inserted (FIG. 2a-b). The blades connect to separate arms of a self-retaining device which allow it to hold open the interval between the supraspinatus and the subscapularis rotator cuff musculotendinous units.

If necessary, a secondary rotator interval can be made by splitting the subscapularis in line with its fibers.

Note, that the anterosuperior passage described above and below can be performed without the aid of the previously described arthroscopic procedure. If the arthroscopic procedure is not performed, joint capsular contractures are released, posterior capsule is tightened (if needed), osteophytes are resected, and the soft-tissue surrounding the glenoid is excised as described above using open rather than arthroscopic instruments.

The surgical method next involves creating atranshumeral portal30. Thetranshumeral portal30 is a cylindrical-like tunnel that is parallel to the neck of the humerus from the anterolateral bony cortex of the proximal humerus through the center of the humeral head. Creation of the transhumeral portal30 first involves obtaining an anteroposterior view of the proximal humerus via the fluoroscopic C-arm machine7 shown inFIG. 1. The shoulder is externally rotated between 20 and 40 degrees relative to the plane of thefluoroscope7 to achieve a view perpendicular to the neck of the humerus. A free radioopaque guide pin is placed over the anterior shoulder along the axis of the humerus neck. By using fluoroscopy, a guide pin in that position defines a line to be used as a guideline that is marked/drawn along the anterior skin. A second small anterosuperior incision is made longitudinally, 1 centimeter lateral to the biceps tendon centered on the point of intersection with the drawn guideline marking the humeral neck axis. This second incision lies just inferolateral to the first. Via the second anterosuperior path, the deep deltoid muscle is split bluntly along its fibers to protect the motor branch of the axillary nerve and the transhumeralportal drill guide14 and protective sleeve15 (FIGS. 3a-c) are inserted down to the anterolateral cortex of the humerus, approximately 1 cm lateral to the biceps groove. Using intraoperative fluoroscopy, asmall guide pin16 is inserted through the transhumeralportal drill guide14 andsleeve15 from the anterolateral humeral cortex along the central axis of the humeral neck into the center of the articular surface of the humeral head (FIG. 4a). Anteroposterior and modified axillary lateral fluoroscopic images are taken to confirm proper positioning of theguide pin16. Theguide pin16 is repositioned as necessary until the pin runs centrally through the humeral neck and head on all fluoroscopic views.

Note, a specialized transhumeralportal drill guide14 may be used to help direct theguide pin16 into the center of the humeral head20 (FIG. 4a). The transhumeralportal drill guide14 is a bullet shaped object with multiple longitudinal cannulations to direct

guide

16,18. It fits into aprotective sleeve15 which has ahandle6 that is inserted into the second anterosuperior passage to the anterolateral cortex of theproximal humerus20. Thissleeve15 and guide14 protect the surrounding soft-tissue and axillary nerve from harm. There is aradiolucent guide attachment21 which rigidly connects to thehandle6 of theprotective sleeve15 of the transhumeralportal drill guide14. Theradiolucent guide attachment21 has aradiolucent arm23 which runs parallel with the

cannulations

10,12 in the transhumeralportal guide14 and connects to aradiolucent tip25 which can be any suitable shape, for example, hemispheric (FIG. 4b). Once the guide is assembled, thecentral cannulation12 of the transhumeralportal guide14 will direct aguide pin16 to the center of thehemispheric tip25. Thearm23 of theguide attachment21 is sufficiently long to allow significant adjustments in length to accommodate variations in size of the proximal humerus. After thetip25 of the transhumeralportal drill guide14 is placed on the humeral surface through the first anterosuperior passage, theradiolucent arm23 containing a radiopaque reference line can also be aligned with the central axis of the neck of theproximal humerus20 under fluoroscopy to assist in directing theguide pin16 to the center of the humeral20 surface.

Theguide pin16 is advanced through thetranshumeral drill guide14 andprotective sleeve15 such that it travels toward the glenohumeral joint9, along the central axis of the neck of the humerus and perpendicular to the humeral20 joint surface. Theguide pin16 is advanced such that the tip of the pin stops right at the humeral20 joint surface. Asecond pin18 of equal length is inserted through one of theperipheral holes10 in the transhumeralportal drill guide14 andsleeve15 until it stops at the lateral humeral cortex. Measuring the difference in exposed length between the

pins

16,18 closely estimates the length of thetranshumeral portal30. This measurement assists the surgeon in creating and using the transhumeral portal30 more safely as well as providing the size of themodular stem98 used for the proximalhumeral implant94. Then, thesecond guide pin18 is advanced into the bone until it reaches the level of the anatomic neck13 of the humerus. Measuring the difference in exposed length between the

pins

16,18 provides an accurate measurement ofhumeral head20 depth (FIG. 4a-b). Using the actual humeral depth measured by the difference between the

pins

16,18 and that measured on the fluoroscopic screen, the actual humeral head diameter can be determined from measurements on the fluoroscopic screen. These measurements help in selecting the proper size transhumeral humeral reamers and final humeral implant later in the procedure.

Based on the actual measured transhumeral portal30 length, thetranshumeral portal30 is created by drilling with an approximately 1 centimeter diameter or less cannulateddrill bit26 through the transhumeral portalprotective sleeve15 over thefirst guide pin16 from the anterolateral humeral cortex and into the joint (FIG. 5). Thetranshumeral portal30 defines an opening of any suitable shape (such as circular, square, triangular, etc), having a diameter with a range of 0.1 to 5 cm, more preferably, a range of 0.1 to 1 cm, and most preferably, a range of 0.5 to 1.0 cm. Thefirst guide pin16 is removed along with the cannulateddrill bit26 and thesecond guide pin18 may remain as a guide for later humeral head resection.

With the formation of thetranshumeral portal30, the humeral20 and glenoid22 surfaces can be prepared as explained hereafter. Note that the order of preparing either the humeral20 or glenoid22 surfaces may be altered depending on theproximal humeral20 bone quality. If there are concerns about the quality of theproximal humeral20 bone, the humeral20 surface can be prepared last, after the glenoid22, to avoid weakening the proximalhumeral bone20 and jeopardizing the integrity of thetranshumeral portal30. Also, if hemiarthroplasty is indicated, the humeral20 surface may solely be prepared and replaced.

Assuming that it is determined to prepare the humeral20 surface first, the articular surface of thehumeral head20 may either be resected and replaced to the level of the anatomic neck13 for the insertion of a conventional proximal humeral implant, or merely resected and replaced to the level of the subchondral bone for the insertion of a novel proximalhumeral implant94. To insert a conventional humeral implant in accordance with the present invention, a preliminaryhumeral head20 cut can be made to improve visualization and expedite resection. From the anterosuperior passage previously formed, a long oscillating saw28 is used to safely resect a limited portion of thehumeral head20 joint surface perpendicular to the portal (FIG. 6).

A transhumeralprotective sheath38 used during the procedure of the present invention is then threaded or press-fit into the transhumeral portal30 through the second anterosuperior passage using the transhumeral portal drill guideprotective sleeve15 to safely direct it. It is inserted to the level of the anatomic neck13 of theproximal humerus20 in preparation for a conventional humeral implant or to the level of the humeral20 joint surface for a novel humeral implant94 (FIG. 7a). An embodiment of the transhumeralprotective sheath38 of the present invention provides protection for the bone within which the transhumeral portal sits. Thetranshumeral sheath38 is a tube of such shape, inner and outer diameter, and thickness such that it interfits securely within thetranshumeral portal30 along the central axis of the neck of thehumerus20, allows easy passage and use of all transhumeral instruments and sleeves while protecting the remaining bone of theproximal humerus20 from harm. Thetranshumeral sheath38 may be metal, plastic, or other semi-rigid, wear-resistant material and may be slid or threaded into the transhumeral portal.

Next, atranshumeral reamer shaft34 is placed through theprotective sheath38 and assembled in the joint with the appropriately sized modularhumeral reamer head36 inserted through the anterosuperior passage (FIGS. 7a-d). A novel transhumeralhumeral reamer32, in one embodiment of the present invention, includes a reamingsurface36 and atranshumeral shaft34. Thetranshumeral reamer32 is designed so that theshaft34 interfits securely within thetranshumeral portal30, and more specifically, within the transhumeralprotective sheath38 within thetranshumeral portal30, such that there is no shaking or toggling while the reamer is being used. Therefore the diameter of theshaft34 is from 0.1 to 5 cm and slightly smaller than the inner diameter of the transhumeralprotective sheath38 through which it traverses. For a conventional humeral prosthesis, a flatreaming head surface36 with sizes similar to the diameter of the humerus and surgical neck are used. The flat reamer removes bone of the humeral head down to the level of the anatomic neck13 of the humerus. For a novelhumeral implant94, a hemispherically shaped reamingsurface37, sized similarly to a novelhumeral surface96 implant component is used, having similar depth and radius of curvature (FIG. 7c). The hemispherically shaped reamingsurface37 removes a minimal amount of bone. The amount of bone removed is roughly equivalent to the thickness of thehumeral surface96 component of theimplant94.

Aprotective guard40 may be placed over the glenoid through the anterosuperior passage during reaming (FIG. 7d). Theprotective guard40 is introduced through the first anterosuperior passage by ahandle44. In one embodiment of the present invention, theguard40 is shaped like the glenoid and is available in small, medium and large sizes. The guard is made of a solid metal surface with an elevated peripheral edge that fits over the glenoid surface. The guard has a thickness of about 0.1 to 2 mm. Thehandle44 is removable and can be attached to the guard at different positions to allow it to be inserted from variable angles through the anterosuperior passage.

After theguard40 is in place, the orthopaedic surgeon grasps theprotective sheath38 and pulls the runningreamer32 back onto the humeral head until it cuts to the level of the anatomic neck13 for a conventional humeral implant (FIG. 7a). Live fluoroscopy may be used to assist with making the cut and insuring that the reamer stays parallel to thesecond guide pin18 and stops before its tip. The bone debris from the cutting is removed with thorough irrigation from the anterosuperior passage. Any remaining humeral osteophytes may be removed with a small rongeur from the anterosuperior passage.

To insert a novel proximalhumeral implant94, the transhumeralprotective sheath38 andreamer shaft34 are inserted as described above (FIGS. 7a-d). Alternatively, the appropriate size novel modularhumeral reamer head37 is inserted through the anterosuperior passage into the joint and assembled with thetranshumeral shaft34. Aprotective guard40 may be placed over the glenoid22 through the anterosuperior passage during reaming. Again, the orthopaedic surgeon grasps theprotective sheath38 and pulls the runningreamer32 back onto the humeral head until the novel humeral reamer has removed just enough bone to restore the proper humeral head dimensions (FIG. 7b). Openings39 in the reamer head can help the surgeon determine the proper amount reaming. Also, live fluoroscopy may be used to assist with making the cut and insuring that thereamer32 stays parallel to thesecond guide pin18 and stops at the appropriate level. The bone debris from the cutting is removed with thorough irrigation and suction from the anterosuperior passage. Any remaining humeral osteophytes may be removed with a small rongeur from the anterosuperior passage.

After thereamer32 has prepared the humeral head, either for a conventional or a novel proximalhumeral implant94, the glenoid22 of the shoulder joint can then prepared for the placement of a conventional glenoid implant115 (FIG. 8a). Any remaining soft-tissue obstructing theglenoid surface22 should be excised. The humerus is abducted, rotated, and laterally distracted to direct the transhumeral portal30 such that its path lies perpendicular to and centered on theglenoid surface22. A glenoid sizing and centeringhole guide46 is placed from the anterosuperior passage (FIG. 8a-c). In another embodiment of the present invention, a glenoid sizer and centeringhole guide46 includes a workingsurface52 and ahandle53. Theguide46 is shaped and sized according to the shape and size of the glenoid22 to be prepared. The workingsurface52 is inserted through the first anterosuperior passage by itshandle53. Thehandle53 is removable and can be attached to the workingsurface52 atdifferent positions56 to allow it to be inserted from variable angles through the anterosuperior passage. The workingsurface52 is approximately 0.1 to 10 mm thick and flat and has acentral hole54.

Utilizing the appropriately sized glenoid sizing and centeringguide46, atranshumeral guide wire50 is inserted into the transhumeral portal30 through the transhumeralprotective sheath38 to to drill a centering hole in theglenoid surface22 regardless of whether a conventional or novel humeral implant is being inserted (FIGS. 8a-b). After the centering hole has been started, theguide wire50 is backed up to allow the removal of the glenoid sizing and centeringguide46. A cannulated flat or hemisphericalhumeral head guard64, followed by a cannulated glenoid surface cuttingreamer head60, is inserted through the anterosuperior passage and theguidewire50 is advanced through cannulations in both instruments back into the centering hole in the glenoid.

In another embodiment of the present invention, a humeral head surfaceprotective guard64 may be used (FIGS. 9a-b). Thisprotective guard64 includes a protective metal surface which is flat or hemispheric in shape corresponding to the prepared end of the proximal humerus for a conventional or novel humeral implant, respectively. Theprotective guard64 is inserted via the first anterosuperior passage and fits over thehumeral surface20 and theshaft62 of the transhumeralglenoid reamer58. Theshaft62 of the transhumeralglenoid reamer58, described below, passes through a central cannulation of theguard64 to prepare the glenoid22. The humeral head surfaceprotective guard64 is sized according to need, such as small, medium, and large. Theguard64 is approximately 0.1 to 2.0 mm thick. Optionally, theguard64 may be used with a handle.

The present invention also provides a transhumeral glenoid reamer58 (FIGS. 9a-b,21,22,23a-b). Theglenoid reamer58 has ashaft62 and a workinghead60. Theshaft62 is designed to interfit securely within thetranshumeral portal30, and more specifically, within the transhumeralprotective sheath38 within thetranshumeral portal30, such that there is no shaking or toggling of theshaft62 within the transhumeral portal30 while the transhumeralglenoid reamer58 is in use. Therefore, the outer diameter of theshaft62 is approximately 0.1 to 5 cm, and slightly less than the inner diameter of the transhumeralprotective sheath38 within which theshaft62 is used. The working glenoid reamer heads60,61 andshaft62 are cannulated to fit over a centralglenoid guide wire50. There is also a non-cannulated reamer head with a leading central peg which can fit into a central glenoid hole and allow some redirection of the reamer as necessary.

For a conventional glenoid implant115 (shown inFIG. 14a), a nearly flat, slightly convex, reaminghead surface60 is used with sizes being similar to that of a glenoid. The radius of curvature of the reamer surface matches that of the non-articular side of the conventional glenoid implant. Theflat reaming head60 removes a minimal thickness of bone. The sameflat reaming head60 as used for a conventionalglenoid implant115 may also be used before inserting the multiple pegged glenoid implant117.

For a novelglenoid implant118, theglenoid reamer head61 includes a peripherally flat, lessaggressive surface116 and a centrally raisedsurface114 which has a more aggressive reaming surface (FIG. 23a-b). The centrally raisedsurface114 may be a convex dome, a square, triangle, pyramid, or any other shape that matches the protruding surface of the novelglenoid implant118 to be implanted within the glenoid, as described below. The peripheralglenoid reaming surface116 removes a minimal amount of bone from the peripheral surface of the glenoid to just correct the version (orientation) of the glenoid surface. In one embodiment, thecentral reaming surface114 removes a spherically shaped area of bone such that a central concave glenoid surface is created which fits aningrowth shell component120 of a novelglenoid implant118 in accordance with the present invention. The concavity is slightly undersized to allow a pressfit of theingrowth shell120.

To prepare the glenoid22 for aconventional prosthesis115, the cannulated transhumeralglenoid reamer shaft62 is positioned over theguidewire50 and through the transhumeralprotective sheath38 from the second anterosuperior passage. Thetranshumeral reamer shaft62 is assembled in the shoulder joint with its glenoid surface cuttingreamer head60 and thereamer58 is advanced along theguide wire50 removing as little bone as possible to correct the profile of the worn glenoid22 and create the proper radius of curvature on the surface to match that of the non-articular surface of the conventionalglenoid implant115. Theguide wire50 must be inserted initially in the proper orientation to direct the cut appropriately. There is also an optional glenoid cutting surface head with a central peg that can be used without theguidewire50 and can be inserted directly into the glenoid centering hole while the surgeon runs the transhumeral glenoid reamer58 (FIGS. 9a, b). The bone debris from the cutting is removed with thorough irrigation from the anterosuperior passage. Any remaining glenoid osteophytes may be removed with a small rongeur from the anterosuperior passage.

The glenoid22 can be prepared for implantation of either a conventional pegged or keeledglenoid implant115, a multiple peg glenoid implant117 (FIG. 20b), or a novelglenoid implant118. In the case of implanting a conventional peg or keelglenoid implant115, the appropriately sized (according to the previously used glenoid sizer and centering hole guide), peg glenoid or keel guide68 is inserted through the anterosuperior passage and centered by placing its peg72 into the previously created glenoid centering hole (FIG. 10a). The transhumeral glenoid drill66 is placed through the transhumeralprotective sheath38 within the transhumeral portal30 from the second anterosuperior passage. In one embodiment of the present invention, a glenoid keel drill guide68 has a working surface69 and a handle70. The working surface69 is introduced via the first anterosuperior passage by its handle70. The handle70 is removable and can be attached to the guide68 at different positions to allow it to be inserted from variable angles through the anterosuperior passage. This drill guide68 is shaped and sized similarly to the glenoid sizing and centeringhole guide46, discussed above. The working surface69 of the guide68 has a central peg72 that fits into a centering hole in the glenoid bone. The drill guide68 for the conventional keel glenoid implant has two converging holes, one superior and one inferior, directed toward each other to direct a transhumeral glenoid drill66 to cut a keel shape into the glenoid bone (FIG. 10b).

The previously mentioned glenoid peg drill guide68 has a working surface69 and a handle70. The working surface69 is inserted through the first anterosuperior passage by its handle70. The handle70 is removable and can be attached to the guide surface69 at different positions to allow it to be inserted from variable angles through the anterosuperior passage. This drill guide68 is sized and shaped similarly to the glenoid sizing and centeringhole guide46, discussed above. The working surface69 of the guide68 has a central peg72 that fits into a centering hole in the glenoid bone. The working surface is approximately 0.1 to 5 mm thick and has peripheral holes in parallel configuration to drill holes with a transhumeral glenoid drill66 for pegs in a glenoid.

In one embodiment, the above-mentioned transhumeral keel/peg glenoid drill66 has a workingsurface67 and a removably attached transhumeral shaft65. The workingsurface67 is a drill bit (or tip) for drilling holes in the glenoid for keels or pegs of the conventionalglenoid implant115. The drill bit67 (or tip) is larger for drilling holes for a keel or a peg than a bit used for drilling holes for screws.

To further prepare the glenoid surface for a conventional glenoid implant, the humerus is positioned and translated such that the transhumeral keel/glenoid glenoid drill66 is maintained perpendicular to the glenoid peg/keel guide surface69. With the gleonid drill introduced through the the transhumeralprotective sheath38 of thetransumeral portal30 and the glenoid drill guide68 postioned from the first anterosuperior passage, holes are drilled into the glenoid (FIGS. 10a-c). To prepare the glenoid to accept a keel glenoid implant, thetranshumeral burr74 is inserted into the transhumeral portal30 through the transhumeralprotective sheath38 and used to connect the drilled holes in the glenoid22 surface (FIGS. 11a-b).

In one embodiment, thetranshumeral burr74 has atranshumeral shaft75 removably attached to a highspeed burr tip73 with different sizes used for cutting holes in a glenoid22, particularly for a keel.

Amodular keel punch76 is used to finish the glenoid keel cut. In an embodiment, where aglenoid keel punch76 is used, thekeel punch76 has a workingsurface77 and a removably attached transhumeral shaft78 (FIGS. 12a-b). The working surface77 (also referred to as a punch head,) is inserted through the first anterosuperior passage and theshaft78 is introduced through the second anterosuperior passage and the transhumeralprotective sheath38. Theshaft78 is assembled with the workingsurface77 in the glenohumeral joint. The workingsurface77 is a head shaped like a keel with cutting teeth to cut a keel shape into aglenoid surface22. Thepunch76 is struck with a hammer to complete the keel shaped cut into the glenoid (FIGS. 12a-b).

The humeral head and glenoid trial implants are inserted through the anterosuperior passage and the rotator interval retractor5 (FIG. 2) is temporarily removed. There are different humeral trial implants that can be used, one for the conventional implant and one for a novel implant. In either case, both can mate with trial modular stems through the transhumeral portal. If there is not sufficient bone available to stabilize the conventional humeral trial with a transhumeral trial stem or the humeral surface is too far offset from the intramedullary axis of the humeral shaft to accurately trial, the intramedullary canal of the humerus can be prepared and fitted with a conventional intramedullary stem trial using conventional techniques and instruments from the anterosuperior passage. Because the rotator cuff has not been transected, it is much simpler to determine the proper size implant required to restore the normal musculotendinous length and tension in the rotator cuff and thus, more accurately restore the native anatomical dimensions of the joint. Fluoroscopy can also be used to judge proper implant size.

Next, the glenoid22 is prepared to affix itsconventional implant115 using transhumeral cementation tools80 (FIGS. 13a-e). A transhumeral irrigation and suction catheter is inserted into the transhumeral portal30 through the novel transhumeralprotective sheath38 and used to irrigate and suck the prepared glenoid22 holes dry. A transhumeral irrigation and suction catheter is used in yet another embodiment of the present invention. The irrigation and suction catheter includes semi-rigid tubing that is inserted through the second anterosuperior passage and the transhumeralprotective sheath38 in the transhumeral portal30 in order to irrigate or suction the prepared glenoid surface. The catheter attaches to both, a fluid pump and suction tubing, and may be easily switched between the two with a stopcock-like device.

The peg or keel holes are temporarily packed with thrombin soaked gel pads or epinephrine soaked gauze using a novel transhumeral forceps device. The transhumeral irrigation and suction catheter is used again to clean and dry the holes and atranshumeral cementation catheter84 is inserted through thetranshumeral portal30 andprotective sheath38 to place the cement.

Note that the above-describedtranshumeral cementation tool80 includes a keel glenoid or peg glenoidcement pressurizer head86 and acementation catheter84. Thetranshumeral cementation catheter84 includes semi-rigid tubing which connects to aconventional cement gun104 to deliver cement to the site of implant fixation to bone. Thehead86 includes a keel glenoid or peg glenoidcement pressurizer tip82 that is cannulated and fits into a respective keel or peg-shaped prepared hole in the glenoid surface to dispense cementation material under pressure into that hole in theglenoid surface22. The pressurizer heads86 are shaped similar to a glenoid implant with a smaller keel or single peg. The radius of curvature of the periphery of thetip82 matches that of the reamed bonyglenoid surface22 to help seal the hole during cement insertion. Theseheads86 are inserted through the first anterosuperior passage by theirhandles88 and are attached to thetranshumeral cementation catheter84 within the glenohumeral joint9 to pressurize the cement in the glenoid22 holes. Thehandle88 is removable and can be attached to thehead86 at different positions to allow it to be inserted from variable angles through the anterosuperior passage. Thecementation head86 limits the escape of cementation material from the hole and allows pressure to build up which forces the cement deep into the interstices of the trabecular bone to allow improved fixation. Acement pressurizer tip82 may be inserted into the joint through the anterosuperior passage and assembled with thetranshumeral cementation catheter84. There are differentpressurizer tips82 to match either the pegged or keeled glenoid. The conventionalglenoid implant115 is inserted through the anterosuperior passage, is seated and held in place until the cement dries with a modular transhumeralglenoid impactor90. Excess cement is removed and the joint is irrigated

The transhumeralglenoid impactor90 includes atranshumeral shaft92 which removably attaches to a workinghead91. The workinghead91 has a convex surface that approximates the radius of curvature of the articular surface of the glenoid implant. Theshaft92 is introduced through transhumeralprotective sheath38 within thetranshumeral portal30. The workinghead91 is introduced through the first anterosuperior passage and mated with thetranshumeral shaft92. Force can then be applied to thehandle89 of the impactor90 to seat theglenoid implant115.

In accordance with an embodiment of the present invention, a multiple peg glenoid implant117 (FIGS. 20a-c) or a novel modular ingrowth glenoid implant118 (FIGS. 26a-b,27a-c) can also be inserted.

After theglenoid surface22 has been reamed by aglenoid reamer58 as described previously, the multiple glenoid pegs117 can be introduced with a novel multiple peg guide72 through the anterosuperior passage and inserted into the prepared surface of the glenoid22 using a transhumeral insertor device79 (FIG. 20a). In another embodiment, a multiple pegglenoid insertor79 and insertor guide72 are used. The multiple peg glenoid insertor guide72 includes ahandle73 and a guidingsurface71. The guidingsurface71 is sized and shaped as the glenoid peg drill guide surface69 discussed above. The guide72 is introduced via the first anterosuperior passage and holds multiple pegs117 to be inserted into the glenoid22. The guidingsurface71 of the guide72 controls the depth and location of insertion of the multiple pegs117.

The multiple pegglenoid insertor79 is inserted via the second anterosuperior passage and through the transhumeralprotective sheath38 in thetranshumeral portal30. It is used to engage the pegs117 located within the multiple peg insertorguide working surface71 and then drives them into the glenoid22 one at a time. Theinsertor79 stops when it hits theguide surface71 to control the depth of peg117 insertion. Drilling pilot holes through a separate guide with a special transhumeral drill can precede this step. Theguide surface71, preloaded with the implant pegs117 controls the position, direction and depth of peg117 insertion. Theguide surface71 has a protruding centering peg which fits into the centering hole of the glenoid to help center and position theguide surface71.

After the multiple peg prosthesis is implanted, trialing of a conventional or novel humeral implant can be performed as described previously.

Alternatively, a novel ingrowthglenoid implant118 can be implanted after reaming the glenoid with a novel transhumeralglenoid reamer57 as described previously. The novel modular ingrowthglenoid implant118 has aningrowth shell120 and modular wear-resistant articulating surface122 (FIGS. 23a-b,26a-b,27a-c)

Theingrowth shell120 of theglenoid implant118 is a cannulated shallow shell with a protrudingsurface119 that sits within the concavity of the reamed glenoid surface. The protruding surface is surrounded by a flat outer surface121 (or brim). The protrudingsurface119 may be any shape such as a square, pyramidal, hemispheric, triangular or any other suitable shape. The protrudingsurface119 protrudes into the glenoid22 to a specified depth. The depth is such that it is enough for theingrowth shell120 to be securely seated within the glenoid22 and for the wear-resistant surface122 to fit therein (as described below) and yet not so deep that a large amount of subchondral bone must be reamed from the glenoid22. Preferably, the shape of the previously described novelglenoid reamer57 is the same as the shape of the protrudingsurface119 of theingrowth shell120 such that there will be a secure fit when theingrowth shell120 is seated within the glenoid22. As theingrowth shell120 is pressed into the glenoid, the flat surface (or annular brim)121 of theingrowth shell120 also makes contact with the peripheralglenoid surface22, and in fact, provides a stopping point of insertion. Theingrowth shell120 is made of suitable material, examples of which include, but are not limited to metal, tantalum, porous metal, trabecular metal, ceramic materials, and titanium. The protrudingsurface119 and theannular brim121 of theshell120 may also maintain a surface of a bony ingrowth material, as described in connection with the humeral implant below. This ingrowth material promotes bone growth and adhesion of the shell to the glenoid surface. Theingrowth shell120 has a thickness of 0.1 to 10 mm, preferably from 0.1 to 2 mm. Theingrowth shell120 has holes for fixation. These holes may be central124 and peripheral126 and may further be smooth, threaded or a combination thereof. In one embodiment, a shell has acentral hole124 and multipleperipheral holes126, for example threeperipheral holes126. Thecentral hole124 is preferably smooth and theperipheral holes126 are preferably threaded.

After reaming, theingrowth shell120 is inserted through the anterosuperior passage and impacted into the concavity (which matches the shape of thereamer head61 and that of the protrudingsurface119 of theingrowth shell120 to be implanted,) of the reamed glenoid with atranshumeral impacting device90. The concavity is slightly undersized to attain a tight fit upon impaction. The ingrowthglenoid shell120 is then fixed to the glenoid22 using

screws

133,135. In one embodiment, acentral compression screw133 is first used to compress the ingrowth shell into the concavity created in the glenoid and affix theingrowth shell120 to the glenoid and then fixed angleperipheral screws135 are used to lock the ingrowth shell into place (FIGS. 25a-b,26a-b).

The transhumeralglenoid drill49 is used along with a transhumeral glenoid drill sleeve48 (FIGS. 24a-b) to make the holes for the

glenoid screws

133,135. The transhumeralglenoid drill sleeve48 fits into a transhumeralglenoid screw sleeve128 which fits into the protectivetranshumeral sheath38 in thetranshumeral portal30. Thedrill sleeve48 mates with the

holes

124,126 in theingrowth shell component120 of the novelglenoid implant118 to direct thedrill49 in the proper orientation. The shaft of the transhumeralglenoid drill49 just fits within the inner diameter of the transhumeralglenoid drill sleeve48 and has visible markings on it that allow one to measure the depth of the hole off the distant edge of the transhumeral drill sleeve48 (FIGS. 24a-b). Thedrill49 is advanced until the far cortex of the glenoid and scapula is reached. At which point, the surgeon reads the mark on the drill at the level of the glenoiddrill guide sleeve48. Approximately 5 mm is added to the screw length to determine the length of screw used. Thedrill49 is then advanced through the far cortex to complete the screw hole in the glenoid22.

In one embodiment of the present invention, a noveltranshumeral screw driver130 and transhumeral glenoidscrew guide sleeve128 are used to place the above described

screws

133,135. After drilling, the surgeon removes the inner transhumeral glenoiddrill guide sleeve48 and thetranshumeral screwdriver130 is inserted through the previously positioned transhumeral glenoidscrew guide sleeve48. Thescrew driver shaft130 fits snuggly within a transhumeral glenoidscrewdriver guide sleeve128. Thescrewdriver130 is then advanced to place a

screw

133,135 through a

hole

124 or126 of theingrowth shell120 of a novelglenoid implant118 into the drilledglenoid bone22. As briefly described above, acentral screw133 is first inserted through a centralsmooth hole124 in theglenoid shell120 to initially compress theingrowth shell120 firmly into theglenoid surface22. Theglenoid ingrowth shell120 is then locked into place by at least oneperipheral screw135, preferably three (FIGS. 25a-b,26a-b). For example, if threeperipheral screws135 are utilized, one is placed anterosuperiorly, one is placed posterosuperiorly, and one is placed inferiorly. The threads of thescrews135 engage the threading of theperipheral holes126 in theglenoid ingrowth shell120 as well as the drilled outer cortical surface of the glenoid22 and scapula. Theperipheral holes126 of theshell120 direct thescrews135 into a fixed divergent pattern.

After theglenoid ingrowth shell120 is well fixed, the modular wear-resistantglenoid surface122 is inserted though the anterosuperior passage and impacted into theshell120 with a transhumeral glenoid impactor90 (FIGS. 14a-b,26a-b) as described previously.

The wear-resistant surface122 of theglenoid implant118 has a convex surface which mates with the concave side of the protrudingsurface119 of theingrowth shell120 and forms the articulating surface of theglenoid implant118. The protrudingsurface119 of theingrowth shell120 is of thin dimension such that it simultaneously provides 1) fixation to the glenoid bone; 2) an ingrowth surface; 3) provides a support surface for the wear-resistant surface122; and4) a recessed coupling device which maximizes the thickness of the wear-resistant surface122 for durability and while still maintaining proper anatomic glenohumeral surface relationships. The wear-resistant surface122 may include, but is not limited to polyethylene, plastic, ceramic material, metals, and magnetic materials. At a minimum, the wear-resistant surface122 has a thickness of 0.1 to 15 mm, preferably 4 to 7 mm, if composed of currently available forms of polyethylene, protruding above the glenoid bony surface and flat outer surface (or annular brim)121 of theingrowth shell120. It may have variable thickness along its dimension to correct version of glenoid. The wear-resistant surface122 of theglenoid implant118, which is approximately pear shaped, has both a superior-inferior dimension and an anterior-posterior dimension. The superior-inferior axis has a suitable range of from about 20 to 60 mm, preferably from about 30 to 48 mm. The anterior-posterior axis defines an upper half and a lower half. The lower half anterior-posterior axis has a range of about 15 to 50 mm, preferably from about 21 to 35 mm. The upper half has a range of from about 10 to 50, preferably 18 to 33 mm. The ratio of the upper half to the lower half is approximately 0.8 to 1.0. The ratio of the lower half of the anterior-posterior axis to the superior-inferior axis is approximately 0.7 to 1.0, whereas the ratio of the upper half of the anterior-posterior axis to the superior-inferior axis is approximately 0.6 to 1.0. In addition, the radius of curvature of the superior-inferior axis of the glenoid surface is greater than the coronal radius of curvature of the humeral surface of the humeral implant with which the glenoid implant articulates. The anterior-posterior radius of curvature of the glenoid surface is larger than the axial radius of curvature of the humeral surface. It may have variable thickness along its dimension to correct version of glenoid.

To prepare the humerus for a conventional humeral implant, the humerus is adducted and extended to line up the axis of the intramedullary canal with the first anterosuperior passage. With the self-retainingrotator interval retractor5 in place, the humeral canal is prepared using conventional instruments, trials are used to determine the proper fit and size of the implants, and the proper conventional humeral implant with an intramedullary stem is either cemented or press-fit into theproximal humerus20 in accordance with the present.

For the novelhumeral implant94, the humerus does not require special positioning. After humeral trialing, the novelhumeral stem98 is placed in the transhumeral portal30 from either the first or second anterosuperior passages and the novelmodular head96 is inserted through the anterosuperior passage. The two

components

96,98 are then mated together.

The novelhumeral implant94 in accordance with the present invention is modular and includes ahumeral surface96 component, a roughly hemispheric shaped surface with a shortcentral mating device100, and atranshumeral stem98 which fills the transhumeral portal30 (FIG. 15a-b). Alternatively, a novel humeral surface implant that includes only ahumeral surface96, with nostem98 may be used when warranted. Preferably, however, a novelhumeral implant94 with two

components

96,98 is used. The two components, thehumeral surface96 andstem98, are removably attached to one another. Thehumeral surface96 has a coronal radius of curvature and an axial radius of curvature. The humeral surface can be spherical in shape. Preferably the humeral surface can be more anatomic being spherical, with equal coronal and axial radii of curvature, in the center and elliptical, with larger coronal than axial radii of curvature, at the periphery. A suitable range for the coronal radius of curvature is from 10 to 50 mm, preferably from 19 to 28 mm, with approximately 81% of all men having a coronal radius of curvature ranging from 23-28 mm, and 79% of all women having coronal radius of curvature ranging from 19-22 mm. A suitable range for the axial radius of curvature of the humeral surface of the implant is from 10 to 50 mm, preferably from 18 to 26 mm. Thehumeral surface96 of theimplant94 also has a depth and thickness. A suitable range for the depth of thehumeral implant94 is from 5 to 40 mm, preferably from 15 to 24 mm, and the depth is the same in both the coronal and axial planes. Thehumeral surface96 thickness has a range of from 0.1 to 5 mm, preferably from 1 to 3 mm. The ratio of the depth to the coronal radius of curvature is approximately 0.7 to 0.9. See Table 1.

	TABLE 1


	Radius of	Depth (mm)

	curvature (mm)	15-17	18-20	21-24

19-20	10	3	2
21-22	7	18	3
23-24	0	9	18
25-26	0	8	14
27-28	0	0	4

Table 1 shows suitable and preferred ranges of radius of curvature and depth for the humeral surface of the humeral implant. (See Iannotti JP, Gabriel JP, Schneck SL, et al. The normal glenohumeral relationships: an anatomical study of one hundred and forty shoulders. J Bone Joint Surg 1992; 74A(4): 491-500.)

Thehumeral surface96 of thehumeral implant94 may be spherically shaped or more of an elliptical shape which better approximates the anatomy of a natural humeral head. Thehumeral surface96 may be made of a variety of materials including, but not limited to cobalt-chrome alloys, ceramic materials, metals, and magnetic materials. It is contemplated that the humeral surface may also have fins, spikes, or other protuberances on its concave, non-articular surface to enhance rotational stability. Additionally, the concave, non-articular surface may also contain a bony ingrowth material. A bony ingrowth material allows the bone to which the implant is attached to grow into the implant and aids in attaining long-lasting fixation of the implant. These ingrowth materials, include, but are not limited to autologous and allograft osteoprogenitor cells and tissues, bone-morphogenic proteins, hydroxyapaptite coating, trabecular metal, porous metal, porous metal coating, and tantalum. It is contemplated that the surface of thehumeral surface component96 of theimplant94 that articulates with the glenoid or the glenoid implant, is smooth with a low coefficient of friction.

Thestem98 of the modularhumeral implant94 is sized to fit within the transhumeral portal30 located along the central axis of the neck of the humerus. By fitting, it is meant that thestem98 fits in a tight manner and is stable in that location. As it is contemplated that thetranshumeral portal30 has a diameter of from 0.1 to 5 cm, the diameter of thestem98 is also from 0.1 to 5 cm, and is dimensioned to fit within thetranshumeral portal30. Thestem98 may be composed of any suitable materials including, but not limited to titanium, stainless steel, cobalt-chrome alloy. Thestem98 may be smooth, textured, or threaded. Smooth glass bead blast finishes are another possibility. Threads may be uniform or may vary in width along the length of the stem. Further, the shape of thestem98 is intended to accommodate the shape of thetranshumeral portal30, therefore it may be round, square, triangular, or any other geometric shape that may comprise thetranshumeral portal30. The main body of thestem98 has a consistent cross-sectional shape and size along its straight longitudinal axis. Therefore, unlike conventional humeral implant stems, which are tapered and bowed to fit within the dimensions of the metaphysis and diaphysis of the humerus, thestem98 of the present invention maintains a uniform diameter and is linear from end to end. As such, the stem is dimensioned to sit within the epiphyseal and metaphyseal portions of the humerus. As described for thehumeral surface96, thestem98 may also contain fins or spikes to aid rotational stability, and it may also possess a bony ingrowth material surface, as describe above.

Thestem98 may be of varying lengths, a suitable range of which is from about 4 to 7 cm. The preferred length is dimensioned to extend from the lateral cortex of the humerus to the center of a humeral head. It is intended that thisstem98 be introduced into thetranshumeral portal30 via the second anterosuperior incision and advanced through the transhumeral portal30 to a position that is suitable for mating with thehumeral surface96 which is inserted via the anterosuperior incision, described above. If appropriate, thestem98 may also be inserted from the articular surface of the proximal humerus through the first anterosuperior passage.

Thehumeral surface96 and stem98 of thehumeral implant94 connect to one another via amating site100. Thehumeral surface96 and stem98 are joined within the glenohumeral joint space. They may be press fit, screwed together, or joined by morse taper, as well as any other suitable locking mechanism. It is possible for the male or female counterpart to be on either thestem98 or thehumeral surface96, so long as one male counterpart and one female counterpart are present in thehumeral implant94.

Example B includes a similarhumeral surface96 component and a cemented transhumeral stem98 (FIGS. 17a-c). Again, thehumeral surface component96 is inserted through the anterosuperior passage, is either cemented or press-fit onto the preparedhumeral surface20 and impacted on the preparedhumeral surface20 against the glenoid22. Anothertranshumeral stem98 which possesses the male end of a morse taper is inserted into the female end on the non-articular side of thehumeral surface component96 and impacted against the glenoid. Thisstem98 may be press-fit or cemented to the bony transhumeral portal. Anendcap106 is threaded into the non-articular side of thestem98 to assist with later removal of thehumeral surface implant94. To fix with cement, acementation catheter84 is assembled to an opening in theendcap106 and cement is injected through the cannulatedtranshumeral stem98 exitingholes99 at its articular end. The cement is injected until it becomes visible around the non-articular end of thestem98. Should it be necessary, removal of the example B implant is conducted by recreating the anterosuperior passages, removing the endcap with a T-handled wrench, threading the removal shaft111 into thestem98, drilling out the cement-implant interface with acoring reamer110 over thestem98, and disimpacting thestem98 from thehumeral surface component96 with a disimpaction sleeve112 (FIGS. 18a-b). Thehumeral surface component96 is removed by sawing across the base of thehumeral surface component96 at the anatomic neck of the humerus with a power or Gigli saw.

Example C includes a similarhumeral surface96 component and an inflatable transhumeral stem98 (FIGS. 19a-b) similar to technology used in the FIXION™ IM Nail (See “A New Expandable Implant for the Repair of Long Bone Fractures”, Sinha, Anjoy M. D. et al, published in www.Healthfocus.com). Again, thehumeral surface component96 is inserted through the anterosuperior passage and either cemented or press-fit, and further impacted on the preparedhumeral surface20 against the glenoid22. Anothertranshumeral stem98 which possesses the male end of a morse taper is inserted into the female end on the non-articular side of thehumeral surface96 component and impacted against the glenoid22. Theinflatable stem98 is an expandable tube that is reinforced with longitudinal bars and has a one-way valve system on the end that doesn't mate with the humeral surface component. Once positioned, thestem98 is inflated or expanded from its collapsed position with a specialized saline pump to fill thestem98, within thetranshumeral portal30, and gain purchase. Thestem98 can be removed by deflating it with the same pump and disimpacting thestem98 from thehumeral surface96 component with adisimpaction sleeve112. Thehumeral surface component96 is removed by sawing across the base of thehumeral surface96 component at the anatomic neck of the humerus with a power or Gigli saw.

After the prosthetic implants, either humeral or glenoid, novel or conventional, are inserted as described above, the soft-tissue tension is evaluated, and the wounds are copiously irrigated, the deep passages, subcutaneous tissue, and skin are closed with sutures.

In yet another embodiment, the present invention is a glenohumeral joint with atranshumeral portal30 along the central axis of the neck of the humerus and at least one implant. The implant may be ahumeral implant94, aglenoid implant118 or both. The implants may be conventional implant or

novel

94,118 described herein.

In an alternative embodiment of the present invention, there is provided a method of repairing a rotator cuff, tear as shown inFIGS. 28-33. This procedure may be utilized in conjunction with the above described method of shoulder replacement or it may be used as a stand-alone procedure. In this method standard positioning and techniques for arthroscopic or open rotator cuff exposure are employed. If performed in conjunction with the previously described methods of shoulder replacement surgery, the anterosuperior passages may be used. If performed in isolation, an open deltoid split or arthroscopic subacromial exposure used for rotator cuff repair is performed in standard fashion. A small longitudinal stab is made through the skin and superficial deltoid fascia approximately 5-12 cm below the level of the anterolateral edge of the acromion.

The suture-pin device141 comprises two components, a leadingflexible pin140 and a swedged onsuture144. Thesuture144 is preferably adurable size #2suture144. Thepin140 has a sharp slightly largerdiameter trocar tip154 on its leading end. The remainingpin140 has a diameter closer to that of thesuture144. Thepin140 is sufficiently long to enter the anterolateral surface of the shoulder, pass through the proximal humerus, rotator cuff, and exit the superior surface of the shoulder with both its leading and trailing ends are exposed. Thesuture144 is of similar length.

It is therefore intended that the foregoing detailed description be regarded as illustrative rather than limiting, and that it be understood that it is the following claims, including all equivalents, that are intended to define the spirit and scope of this invention.

A complete listing of the claims with proper claim identifiers is set forth below.