WO2005016123A2 - Devices and methods used for shoulder replacement - Google Patents

Devices and methods used for shoulder replacement Download PDF

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Publication number
WO2005016123A2
WO2005016123A2 PCT/US2004/026085 US2004026085W WO2005016123A2 WO 2005016123 A2 WO2005016123 A2 WO 2005016123A2 US 2004026085 W US2004026085 W US 2004026085W WO 2005016123 A2 WO2005016123 A2 WO 2005016123A2
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WO
WIPO (PCT)
Prior art keywords
implant
glenoid
transhumeral
humeral
guide
Prior art date
Application number
PCT/US2004/026085
Other languages
French (fr)
Other versions
WO2005016123A3 (en
Inventor
Steven C. M. D. Chudik
Original Assignee
Chudik Steven C M D
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Family has litigation
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Application filed by Chudik Steven C M D filed Critical Chudik Steven C M D
Publication of WO2005016123A2 publication Critical patent/WO2005016123A2/en
Publication of WO2005016123A3 publication Critical patent/WO2005016123A3/en

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    • AHUMAN NECESSITIES
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/40Joints for shoulders
    • A61F2/4003Replacing only the epiphyseal or metaphyseal parts of the humerus, i.e. endoprosthesis not comprising an entire humeral shaft
    • AHUMAN NECESSITIES
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    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1662Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1684Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the shoulder
    • AHUMAN NECESSITIES
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    • A61B17/17Guides or aligning means for drills, mills, pins or wires
    • A61B17/1703Guides or aligning means for drills, mills, pins or wires using imaging means, e.g. by X-rays
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    • A61B17/17Guides or aligning means for drills, mills, pins or wires
    • A61B17/1721Guides or aligning means for drills, mills, pins or wires for applying pins along or parallel to the axis of the femoral neck
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    • A61B17/1739Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1778Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the shoulder
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    • A61F2/4603Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4612Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of shoulders
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    • A61B17/1735Guides or aligning means for drills, mills, pins or wires for rasps or chisels
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    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06Measuring instruments not otherwise provided for
    • A61B2090/061Measuring instruments not otherwise provided for for measuring dimensions, e.g. length
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    • A61B90/08Accessories or related features not otherwise provided for
    • A61B2090/0801Prevention of accidental cutting or pricking
    • A61B2090/08021Prevention of accidental cutting or pricking of the patient or his organs
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
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    • A61F2/4081Glenoid components, e.g. cups
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2002/30535Special structural features of bone or joint prostheses not otherwise provided for
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Definitions

  • 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.
  • 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.
  • the metal-backed glenoid prosthesis has an unacceptable rate of early loosening, at least 20% in one study.
  • 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 [0010] 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.
  • 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 in the process. [0012]
  • 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. [0013] A further advantage is that it spares the rotator cuff tendons and allows for a quicker and more functional recovery [0014] Another aspect of the present invention regards a humeral implant with one component that is removably attached to a second component.
  • the glenoid implant includes an ingrowth shell, a wear- resistant surface that is removably attached to the ingrowth shell.
  • An additional aspect of the invention regards a transhumeral portal sleeve with a bullet shaped guide that has a central cannulation and a peripheral longitudinal cannulation.
  • An advantage is that it safely creates a working portal along the central axis of the proximal humerus.
  • 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.
  • a transhumeral protective sheath is provided that is a tube of material with a diameter of from 0.1 to 5 cm.
  • a glenoid surface protective guard that has a protective surface and a removably attached handle.
  • a humeral head surface protective guard 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.
  • 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.
  • the invention regards a transhumeral glenoid drill with a working surface and a removably attached shaft.
  • a transhumeral burr in another aspect, 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.
  • 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.
  • a transhumeral cementation device 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.
  • 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.
  • Figure 1 is a schematic of a patient positioned with fluoroscopy C-arm unit that may be used in conjunction with the present inventions;
  • Figures 2a and b are plan views of an embodiment of a rotator interval retractor with specialized supraspinatus and subscapularis blades ( Figure 2b) in accordance with the present invention;
  • Figure 3a is a perspective view of an embodiment of a transhumeral portal drill guide and protective sleeve in accordance with the present invention.
  • Figure 3b is a top plan view of the transhumeral portal drill guide and protective sleeve of Figure 3a;
  • Figure 3c is a side plan view of the protective sleeve of the transhumeral portal drill guide and sleeve of Figure 3a in accordance with the present invention;
  • Figure 4a is 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;
  • Figure 4b is a schematic of the insertion of Figure 4a using an optional embodiment of a radiolucent guide attachment to assist with a guide pin insertion procedure in accordance with the present invention;
  • Figure 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;
  • Figure 6 is a schematic of a preliminary cut of a humeral head joint surface during an embodiment
  • Figure 7b is a schematic showing a possible way of preparing the humeral head with a transhumeral 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
  • Figure 7c is 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
  • Figure 7d is 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
  • Figure 8a is 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
  • Figure 8b is 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
  • Figure 8c is a perspective view of an embodiment of a head of a glenoid sizing and centering guide in accordance with the present invention
  • Figure 9a is 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
  • Figure 9b is 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
  • Figure 10a is 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
  • Figure 10b is 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
  • Figure 10c is 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
  • Figure 11 a is 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
  • Figure 11 b is 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
  • Figure 12a is 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
  • Figure 12b is 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
  • Figure 13a is 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
  • Figure 13b is 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 in Figure 13a;
  • Figure 13c is an exploded view of an embodiment of a glenoid cement pressurizer tip of Figures 13a and b in accordance with the present invention
  • Figure 13d is an exploded view of an embodiment of a glenoid cement pressurizer tip for a peg implant of Figures 13 a, b and c in accordance with the present invention
  • Figure 13e is a schematic of a way of utilizing an embodiment of a transhumeral for a novel proximal humeral implant to be used during a surgical procedure in accordance with the present invention
  • Figure 14a a 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
  • Figure 14b is 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
  • Figure 15a is a exploded view of humeral implant in accordance with the present invention
  • Figure 15b is a bottom plan view of a humeral implant in accordance with the present invention
  • Figure 16 is a schematic of an embodiment of a humeral surface implant, Example A, in accordance with the present invention.
  • Figure 17a is schematic of an embodiment of a humeral surface implant, Example B, in accordance with the present invention.
  • Figure 17b is a perspective view of an embodiment of a stem with inner cement channels in accordance with the present invention.
  • Figure 17c is an perspective view of an embodiment of a endcap of the novel transhumeral stem of Figure 17b in accordance with the present invention.
  • Figure 18a is a schematic of a way of removing an embodiment of a humeral surface implant, Step 1 , Example B, during an embodiment of a surgical procedure in accordance with the present invention
  • Figure 18b is a schematic of a way of performing Step 2 of removing an embodiment of a humeral surface implant of Figure 18a during an embodiment of a surgical procedure in accordance with the present invention
  • Figure 19a is a schematic of inserting an embodiment of a humeral surface implant, Example C in accordance with the present invention.
  • Figure 19b is a perspective view of a stem of an embodiment of a humeral implant of Figure 19a that is inflatable in accordance with the present invention
  • Figure 20a is 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
  • Figure 20b is a side plan view of a glenoid peg to be used in during a surgical technique in accordance with the present invention
  • Figure 20c is a perspective view of a multiple peg glenoid guide of Figure 20a in accordance with the present invention
  • Figure 21 is a side perspective view of an embodiment of a novel glenoid reamer in accordance with the present invention.
  • Figure 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
  • Figure 23a is a perspective view of an embodiment of a shell component of a novel glenoid implant in accordance with the present invention.
  • Figure 23b is a bottom plan view of a shell component of a novel glenoid implant of Figure 23a;
  • Figure 24a is 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
  • Figure 24b is an exploded view of the glenoid drill guide sleeve interfit with the glenoid screw guide sleeve of Figure 24a;
  • Figure 25a is 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
  • Figure 25b is an exploded view of the glenoid screw drive sleeve of Figure 25a;
  • Figure 26a is 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
  • Figure 26b is an exploded view of the novel glenoid implant of
  • Figure 27a is a side view of an embodiment of a novel glenoid implant in accordance with the present invention
  • Figure 27b is a top plan view of an embodiment of a novel wear-resistant surface the novel glenoid implant of Figure 27a
  • Figure 27c is a bottom plan view of an embodiment of the novel wear-resistant surface of novel glenoid implant of Figures 27a and b.
  • Figure 28 is a perspective view of an embodiment of an insertional guide in accordance with the present invention
  • Figure 29 is a perspective view of an embodiment of a flexible inner trocar of an embodiment of an insertion guide in accordance with the present invention
  • Figure 30 is a schematic of a way of performing an embodiment of a surgical technique using the insertion guide of Figures 28-29 to bore into a greater tuberosity of proximal humerus in accordance with the present invention
  • Figure 31 is a schematic of a way of performing an embodiment of a surgical technique using the insertion guide of Figures 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
  • Figure 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
  • Figure 33 is a
  • 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.
  • 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.
  • 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.
  • 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.
  • 11a-b, 12a-b, 13a, 13e, 14a-b, 16, 17a, 18a-b, 19a, 20a, 22, 24a, 25a, and 26a is a possible medical procedure according to the present invention.
  • 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.
  • 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.
  • 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.
  • a fluoroscopic C- arm machine Prior to prepping and draping the patient, a fluoroscopic C- arm machine is positioned accordingly to the patient to obtain a Grashey anteroposterior radiographic view and a modified axiliary lateral view using rotation of the shoulder and slight repositioning of the fluoroscopic machine. After the fluoroscopic views are confirmed, the fluoroscopic machine is backed away from the patient and the shoulder and upper extremity are prepped and draped in sterile fashion. [00103] 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.
  • an accessory posterior passage is made under needle localization and an arthroscopic burr is inserted to remove the inferior humeral neck osteophytes.
  • 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).
  • an anterosuperior passage is formed to expose the glenohumeral joint.
  • 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.
  • a novel rotator interval retractor 5 with specialized supraspinatus 2 and subscapularis 4 blades is inserted ( Figure 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.
  • a secondary rotator interval can be made by splitting the subscapularis in line with its fibers.
  • anterosuperior passage desc ⁇ bed 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 a transhumeral portal.
  • the transhumeral portal 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 portal first involves obtaining an anteroposterior view of the proximal humerus via the fluoroscopic C-arm machine shown in Figure 1.
  • the shoulder is externally rotated between 20 and 40 degrees relative to the plane of the fluoroscope 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.
  • 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.
  • the deep deltoid muscle is split bluntly along its fibers to protect the motor branch of the axillary nerve and the transhumeral portal drill guide 14 and protective sleeve 15 (Figures 3a- c) are inserted down to the anterolateral cortex of the humerus, approximately 1 cm lateral to the biceps groove.
  • a small guide pin 16 is inserted through the transhumeral portal drill guide 14 and sleeve 15 from the anterolateral humeral cortex along the central axis of the humeral neck into the center of the articular surface of the humeral head ( Figure 4a).
  • Anteroposterior and modified axillary lateral fluoroscopic images are taken to confirm proper positioning of the guide pin 16.
  • the guide pin 16 is repositioned as necessary until the pin runs centrally through the humeral neck and head on all fluoroscopic views.
  • a specialized transhumeral portal drill guide extension 20, 25 may be used to help direct the guide pin 16 into the center of the humeral head (Figure 4a).
  • the transhumeral portal drill guide 14 is a bullet shaped object with multiple longitudinal cannulations to direct guide wires 50. It fits into a protective sleeve 15 which has a handle that is inserted into the second anterosuperior passage to the anterolateral cortex of the proximal humerus 30. This sleeve 15 and guide 24 protect the surrounding soft-tissue and axillary nerve from harm.
  • There is a radiolucent guide attachment 21 which rigidly connects to the handle of the protective sleeve 15 of the transhumeral portal drill guide 14.
  • the radiolucent guide attachment 21 has a radiolucent arm 23 which runs parallel with the cannulations in the transhumeral portal guide 14 and connects to a radiolucent tip 25 which can be any suitable shape, for example, hemispheric ( Figure 4b). Once the guide is assembled, the central cannulation of the transhumeral portal guide 14 will direct a guide pin 16 to the center of the hemispheric tip 25.
  • the arm 23 of the guide attachment 21 is sufficiently long to allow significant adjustments in length to accommodate variations in size of the proximal humerus.
  • the radiolucent arm 23 containing a radiopaque reference line can also be aligned with the central axis of the neck of the proximal humerus 22 under fluoroscopy to assist in directing the guide pin 16 to the center of the humeral surface.
  • the guide pin 16 is advanced through the transhumeral drill guide 14 and protective sleeve 15 such that it travels toward the glenohumeral joint 7, along the central axis of the neck of the humerus and perpendicular to the humeral joint surface 21.
  • the guide pin 16 is advanced such that the tip of the pin stops right at the humeral joint surface 21.
  • a second pin 18 of equal length is inserted through one of the peripheral holes in the transhumeral portal drill guide 14 and sleeve 15 until it stops at the lateral humeral cortex. Measuring the difference in exposed length between the pins 16, 18 closely estimates the length of the transhumeral portal 30.
  • This measurement assists the surgeon in creating and using the transhumeral portal 30 more safely as well as providing the size of the modular stem 98 used for the proximal humeral implant 94.
  • the second guide pin 18 is advanced into the bone until it reaches the level of the anatomic neck 3 of the humerus. Measuring the difference in exposed length between the pins 16, 18 provides an accurate measurement of humeral head depth ( Figure 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.
  • the transhumeral portal 30 is created by drilling with an approximately 1 centimeter diameter or less cannulated drill bit through the transhumeral portal protective sleeve 15 over the first guide pin 16 from the anterolateral humeral cortex and into the joint (Figure 5).
  • the transhumeral portal 30 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.
  • the first guide pin 16 is removed along with the cannulated drill bit and the second guide pin 18 may remain as a guide for later humeral head resection.
  • the humeral 20 and glenoid 22 surfaces can be prepared as explained hereafter. Note that the order of preparing either the humeral 20 or glenoid 22 surfaces may be altered depending on the proximal humeral 20 bone quality. If there are concerns about the quality of the proximal humeral 20 bone, the humeral surface can be prepared last, after the glenoid, to avoid weakening the proximal humeral bone 20 and jeopardizing the integrity of the transhumeral portal. Also, if hemiarthroplasty is indicated, the humeral surface 21 may solely be prepared and replaced.
  • the articular surface of the humeral head 20 may either be resected and replaced to the level of the anatomic neck 3 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 proximal humeral implant.
  • a preliminary humeral head cut can be made to improve visualization and expedite resection.
  • a long oscillating saw 28 is used to safely resect a limited portion of the humeral head 20 joint surface perpendicular to the portal ( Figures 5 and 6).
  • a transhumeral protective sheath 38 used during the procedure of the present invention is then threaded or press-fit into the transhumeral portal 30 through the second anterosuperior passage using the transhumeral portal protective sleeve 15 to safely direct it. It is inserted to the level of the anatomic neck 3 of the proximal humerus 20 in preparation for a conventional humeral implant or to the level of the joint surface 21 for a novel humeral implant ( Figure 7a).
  • transhumeral protective sheath 38 of the present invention provides protection for the bone within which the transhumeral portal sits.
  • the transhumeral sheath 38 is a tube of such shape, inner and outer diameter, and thickness such that it interfits securely within the transhumeral portal 30 along the central axis of the neck 3 of the humerus 20, allows easy passage and use of all transhumeral instruments and sleeves while protecting the remaining bone of the proximal humerus from harm.
  • the transhumeral sheath 38 may be metal, plastic, or other semi-rigid, wear-resistant material and may be slid or threaded into the transhumeral portal.
  • a transhumeral reamer shaft 34 is placed through the protective sheath 38 and assembled in the joint with the appropriately sized modular humeral reamer head 36 inserted through the anterosuperior passage ( Figures 7a-d).
  • a novel transhumeral humeral reamer 32 in one embodiment of the present invention, includes a reaming surface 36 and a transhumeral shaft 34.
  • the transhumeral reamer 32 is designed so that the shaft 34 interfits securely within the transhumeral portal 30, and more specifically, within the transhumeral protective sheath 38 within the transhumeral portal 30, such that there is no shaking or toggling while the reamer is being used.
  • the diameter of the shaft 34 is from 0.1 to 5 cm and slightly smaller than the inner diameter of the transhumeral protective sheath 38 through which it traverses.
  • a flat reaming head surface 36 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 neck 3 of the humerus.
  • a novel humeral implant 94 a hemispherically shaped reaming surface 36, sized similarly to a novel humeral surface 96 implant component is used, having similar depth and radius of curvature (Figure 7c).
  • the hemispherically shaped reaming surface 36 removes a minimal amount of bone. The amount of bone removed is roughly equivalent to the thickness of the humeral surface 96 component of the implant.
  • a protective guard 40 may be placed over the glenoid through the anterosuperior passage during reaming ( Figure 7d).
  • the protective guard 40 is introduced through the first anterosuperior passage by a handle 44.
  • the guard 40 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.
  • the handle 44 is removable and can be attached to the guide at different positions to allow it to be inserted from variable angles through the anterosuperior passage.
  • the orthopaedic surgeon grasps the protective sheath 38 and pulls the running reamer 32 back onto the humeral head until it cuts to the level of the anatomic neck 3 for a conventional humeral implant (Figure 7a).
  • Live fluoroscopy may be used to assist with making the cut and insuring that the reamer stays parallel to the second guide pin 18 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.
  • transhumeral protective sheath 38 and reamer shaft 34 are inserted as described above ( Figures 7a-d).
  • the appropriate size novel modular humeral reamer head 36 is inserted through the anterosuperior passage into the joint and assembled with the transhumeral shaft 34.
  • a protective guard 40 may be placed over the glenoid 22 through the anterosuperior passage during reaming.
  • the orthopaedic surgeon grasps the protective sheath 38 and pulls the running reamer 32 back onto the humeral head until the novel humeral reamer has removed just enough bone to restore the proper humeral head dimensions with the reamer 32 ( Figure 7b). Openings 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 the reamer 32 stays parallel to the second guide pin 18 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.
  • the glenoid 22 of the shoulder joint is then prepared for the placement of a glenoid implant 118 ( Figure 8a). Any remaining soft-tissue obstructing the glenoid surface 22 should be excised.
  • the humerus is abducted, rotated, and laterally distracted to direct the working transhumeral portal 30 such that its path lies perpendicular to and centered on the glenoid surface 22.
  • a glenoid sizing and centering hole guide 46 is placed from the anterosuperior passage ( Figure 8b-c).
  • a glenoid sizer and centering hole guide 46 includes a working surface 52 and a handle 53.
  • the guide 46 is shaped and sized according to the shape and size of the glenoid 22 to be prepared.
  • the working surface 52 is inserted through the first anterosuperior passage by its handle 53.
  • the handle 53 is removable and can be attached to the working surface 52 at different positions to allow it to be inserted from variable angles through the anterosuperior passage.
  • the working surface is approximately 0.1 to 10 mm thick and flat.
  • a transhumeral guide wire 50 is inserted into the transhumeral portal 30 through the transhumeral protective sheath 38 to allow a drill 49 to drill a centering hole on the glenoid surface 22 regardless of whether a conventional or novel humeral implant is being inserted ( Figures 8a-b). .
  • the guide wire 50 is backed up to allow the removal of the glenoid sizing and centering guide 46.
  • a humeral head surface protective guard 64 may be used ( Figures 9a-b).
  • This protective guard 64 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.
  • the protective guard 64 is inserted via the first anterosuperior passage and fits over the humeral surface 20 and the shaft 62 of the transhumeral glenoid reamer 58.
  • the shaft 62 of the transhumeral glenoid reamer 58 described below, passes through a central cannulation of the guard 64 to prepare the glenoid 22.
  • the humeral head surface protective guard 64 is sized according to need, such as small, medium, and large.
  • the guard 64 is approximately 0.1 to 2.0 mm thick.
  • the guard 64 may be used with a handle.
  • the present invention also provides a transhumeral glenoid reamer 58 ( Figures 9a-b, 21 , 22, 23a-b).
  • the glenoid reamer 58 has a shaft 62 and a working head 60.
  • the shaft 62 is designed to interfit securely within the transhumeral portal 30, and more specifically, within the transhumeral protective sheath 38 within the transhumeral portal 30, such that there is no shaking or toggling of the shaft 62 within the transhumeral portal 30 while the transhumeral glenoid reamer 58 is in use. Therefore, the outer diameter of the shaft 62 is approximately 0.1 to 5 cm, and slightly less than the inner diameter of the transhumeral protective sheath 38 within which the shaft 62 is used.
  • the working glenoid reamer heads 60 and shafts 62 are cannulated to fit over a central glenoid guide wire 50. 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.
  • a nearly flat, slightly convex, reaming head surface 60 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.
  • the flat reaming head 60 removes a minimal thickness of bone.
  • the glenoid reaming head 60 includes a peripherally flat, less aggressive surface 116 and a centrally raised surface 114 which has a more aggressive reaming surface (Figure 23a-b).
  • the centrally raised surface 114 may be a convex dome, a square, triangle, pyramid, or any other shape that matches the protruding surface of the novel glenoid implant 118 to be implanted within the glenoid, as described below.
  • the peripheral glenoid reaming surface 116 removes a minimal amount of bone from the peripheral surface of the glenoid to just correct the version (orientation) of the glenoid surface.
  • the central reaming surface 114 removes a spherically shaped area of bone such that a central concave glenoid surface is created which fits an ingrowth shell component 120 of a novel glenoid implant 118 in accordance with the present invention.
  • the concavity is slightly undersized to allow a pressfit of the ingrowth shell 120.
  • the cannulated transhumeral glenoid reamer shaft 62 is positioned over the guidewire 50 and through the transhumeral protective sheath 38 from the second anterosuperior passage.
  • the transhumeral reamer shaft 62 is assembled in the shoulder joint with its glenoid surface cutting reamer head 60 and the reamer 58 is advanced along the guide wire 50 removing as little bone as possible to correct the profile of the worn glenoid and create the proper radius of curvature on the surface to match that of the non-articular surface of the conventional glenoid implant.
  • the guide wire 50 must be inserted initially in the proper orientation to direct the cut appropriately.
  • glenoid cutting surface head 60 with a central peg that can be used without the guide wire 50 and can be inserted directly into the glenoid centering hole while the surgeon runs the transhumeral glenoid reamer 58 ( Figures 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 glenoid 22 can be prepared for implantation of either a conventional pegged or keeled glenoid implant, a multiple peg glenoid implant ( Figure 20b), or a novel glenoid implant 118.
  • a conventional peg or keel glenoid implant the appropriately sized (according to the previously used glenoid sizer and centering hole guide), peg glenoid or keel guide 68 is inserted through the anterosuperior passage and centered by placing its peg 72 into the previously created glenoid centering hole ( Figure 10a).
  • a glenoid keel drill guide 68 has a working surface 69 and a handle 70.
  • the working surface 69 is introduced via the first anterosuperior passage by its handle 70.
  • the handle 70 is removable and can be attached to the guide 68 at different positions to allow it to be inserted from variable angles through the anterosuperior passage.
  • This drill guide 68 is shaped and sized similarly to the glenoid sizing and centering hole guide 46, discussed above.
  • the working surface 69 of the guide 68 has a central peg 72 that fits into a centering hole in the glenoid bone.
  • the drill guide 68 for the conventional keel glenoid implant has two converging holes, one superior and one inferior, directed toward each other to direct a transhumeral glenoid drill 66 to cut a keel shape into the glenoid bone ( Figure 10b).
  • the previously mentioned glenoid peg drill guide 68 has a working surface 69 and a handle 70.
  • the working surface 69 is inserted through the first anterosuperior passage by its handle 70.
  • the handle 70 is removable and can be attached to the guide surface 69 at different positions to allow it to be inserted from variable angles through the anterosuperior passage.
  • This drill guide 68 is sized and shaped similarly to the glenoid sizing and centering hole guide 46, discussed above.
  • the working surface 69 of the guide 68 has a central peg 72 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 drill 66 for pegs in a glenoid.
  • the above-mentioned transhumeral keel/peg glenoid drill 66 has a working surface 67 and a removably attached transhumeral shaft 65.
  • the working surface 67 is a drill bit (or tip) for drilling holes in the glenoid for keels or pegs of the conventional glenoid implant.
  • the drill bit 67 (or tip) is larger for drilling holes for a keel or a peg than a bit used for drilling holes for screws.
  • the humerus is positioned and translated such that the transhumeral keel/glenoid glenoid drill 66 is maintained perpendicular to the glenoid peg/keel guide surface 69.
  • the gleonid drill introduced through the the transhumeral protective sheath 38 of the transumeral portal 30 and the glenoid drill guide 68 postioned from the first anterosuperior passage, holes are drilled into the glenoid ( Figures 10a- c).
  • the transhumeral burr 74 is inserted into the transhumeral portal 30 through the transhumeral protective sheath 38 and used to connect the drilled holes in the glenoid surface ( Figures 11a-b).
  • the transhumeral burr 74 has a transhumeral shaft 75 removably attached to a high speed burr tip 73 with different sizes used for cutting holes in a glenoid, particularly for a keel.
  • a modular keel punch 76 is used to finish the glenoid keel cut.
  • the keel punch 76 has a working surface 77 and a removably attached transhumeral shaft 78 ( Figures 12a-b).
  • the working surface 77 also referred to as a punch head, is inserted through the first anterosuperior passage and the shaft 78 is introduced through the second anterosuperior passage and the transhumeral protective sheath 38.
  • the shaft 78 is assembled with the working surface 77 in the glenohumeral joint.
  • the working surface 77 is a head shaped like a keel with cutting teeth to cut a keel shape into a glenoid surface 22.
  • the punch 76 is struck with a hammer to complete the keel shaped cut into the glenoid ( Figures 12a-b).
  • the humeral head and glenoid trial implants are inserted through the anterosuperior passage and the rotator interval retractor 5 ( Figure 2) is temporarily removed.
  • the glenoid 22 is prepared to affix its conventional implant 115 using transhumeral cementation tools 80 ( Figures 13a-e).
  • a transhumeral irrigation and suction catheter is inserted into the transhumeral portal 30 through the novel transhumeral protective sheath 38 and used to irrigate and suck the prepared glenoid 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 transhumeral protective sheath 38 in the transhumeral portal 30 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 a transhumeral cementation catheter 84 is inserted through the transhumeral portal 30 and protective sheath 38 to place the cement.
  • transhumeral cementation tool 80 includes a modular with keel glenoid and peg glenoid cement pressurizer head 86 and cementation catheter 84.
  • the transhumeral cementation catheter 84 includes semi-rigid tubing which connects to a conventional cement gun 104 to deliver cement to the site of implant fixation to bone.
  • the head 86 includes a keel glenoid or peg glenoid cement pressurizer tip 82 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 the glenoid surface 22.
  • the pressurizer head 86 are shaped similar to a glenoid with a smaller keel or single peg.
  • the radius of curvature of the periphery of the tip 82 matches that of the reamed bony glenoid surface 22 to help seal the hole during cement insertion
  • These heads 86 are inserted through the first anterosuperior passage by their handles 88 and are attached to the transhumeral cementation catheter 84 within the glenohumeral joint 7 to pressurize the cement in the glenoid holes.
  • the handle 88 is removable and can be attached to the head 86 at different positions to allow it to be inserted from variable angles through the anterosuperior passage.
  • the cementation head 86 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.
  • a cement pressurizer tip 82 may be inserted into the joint through the anterosuperior passage and assembled with the transhumeral cementation catheter 84. There are different pressurizer tip82 to match either the pegged or keeled glenoid.
  • the conventional glenoid implant 115 is inserted through the anterosuperior passage, is seated and held in place until the cement dries with a modular transhumeral glenoid impactor 90. Excess cement is removed and the joint is irrigated
  • the transhumeral glenoid impactor 90 includes a transhumeral shaft 92 which removably attaches to a working head 91.
  • the working head 91 has a convex surface that approximates the radius of curvature of the articular surface of the glenoid implant.
  • the shaft 92 is introduced through transhumeral protective sheath 38 within the . transhumeral portal 30.
  • the working head 91 is introduced through the first anterosuperior passage and mated with the transhumeral shaft 92. Force can then be applied to the handle 89 of the impactor 90 to seat the glenoid implant 115.
  • a multiple peg glenoid implant 115 ( Figures 20a-c) or a novel modular ingrowth glenoid implant 118 ( Figures 23a-b, 27a-c) can also be inserted.
  • the multiple glenoid pegs 61 can be introduced with a novel multiple peg guide 67 through the anterosuperior passage and inserted into the prepared surface of the glenoid 22 using a transhumeral insertor device 79 ( Figure 20a).
  • a multiple peg glenoid insertor 79 and insertor guide 67 are used.
  • the multiple peg glenoid insertor guide 67 includes a handle 73 and a guiding surface 71.
  • the guiding surface 71 is sized and shaped as the glenoid peg drill guide 67 discussed above.
  • the guide 67 is introduced via the first anterosuperior passage and holds multiple pegs 61 to be inserted into the glenoid 22.
  • the guiding sur ace 71 of the guide 67 controls the depth and location of insertion of the multiple pegs 61.
  • the multiple peg glenoid insertor 79 is inserted via the second anterosuperior passage and through the transhumeral protective sheath 38 in the transhumeral portal 30.
  • the insertor 79 stops when it hits the guide surface 71 to control the depth of peg 61 insertion. Drilling pilot holes through a separate guide with a special transhumeral drill can precede this step.
  • the guide surface, preloaded with the implant pegs 61 controls the position, direction and depth of peg 61 insertion.
  • the guide surface 71 has a protruding centering peg 61 which fits into the centering hole of the glenoid to help center and position the guide surface 71.
  • a novel ingrowth glenoid implant 118 can be implanted after reaming the glenoid with a novel transhumeral glenoid reamer 57 as described previously.
  • the novel modular ingrowth glenoid implant 118 has an ingrowth shell 120 and modular wear-resistant articulating surface 122 ( Figures 23a-b, 27a-c) [00141]
  • the ingrowth shell 120 of the glenoid implant 118 is a cannulated shallow shell with a protruding surface that sits within the concavity of the reamed glenoid surface.
  • the protruding surface is surrounded by a flat outer surface 121 (or brim).
  • the protruding surface 119 may be any shape such as a square, pyramidal, hemispheric, triangular or any other suitable shape.
  • the protruding surface protrudes into the glenoid to a specified depth. The depth is such that it is enough for the ingrowth shell 120 to be securely seated within the glenoid and for the wear-resistant surface 122 to fit therein (as described below) and yet not so deep that a large amount of subchondral bone must be reamed from the glenoid.
  • the shape of the previously described novel glenoid reamer 57 is the same as the shape of the protruding surface 119 of the ingrowth shell 120 such that there will be a secure fit when the ingrowth shell 120 is seated within the glenoid 22.
  • the flat surface (or annular brim) 121 of the ingrowth shell 120 also makes contact with the peripheral glenoid surface 22, and in fact, provides a stopping point of insertion.
  • the ingrowth shell 120 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 ingrowth shell 120 has a thickness of 0.1 to 10 mm, preferably from 0.1 to 2 mm.
  • the ingrowth shell 120 has holes for fixation. These holes may be central 124 and peripheral 126 and may further be smooth, threaded or a combination thereof.
  • a shell has a central hole 124 and multiple peripheral holes 126, for example three peripheral holes 126.
  • the central hole 124 is preferably smooth and the peripheral holes 126 are preferably threaded.
  • the ingrowth shell 120 is inserted through the anterosuperior passage and impacted into the concavity (which matches the shape of the reamer head 60 and that of the protruding surface 119 of the ingrowth shell 120 to be implanted,) of the reamed glenoid with a transhumeral impacting device 90.
  • the concavity is slightly undersized to attain a tight fit upon impaction.
  • the ingrowth glenoid shell 120 is then fixed to the glenoid 22 using screws 133, 135.
  • a central compression screw 133 is first used to compress the ingrowth shell into the concavity created in the glenoid and affix the ingrowth shell
  • the transhumeral glenoid drill 49 is used along with a transhumeral glenoid drill sleeve 48 ( Figures 24a-b) to make the holes for the glenoid screws 133, 135.
  • the transhumeral glenoid drill sleeve 48 fits into a transhumeral glenoid screw sleeve 128 which fits into the protective transhumeral sheath 38 in the transhumeral portal 30.
  • the drill sleeve 128 mates with the holes 124, 126 in the ingrowth shell component 120 of the novel glenoid implant to direct the drill 49 in the proper orientation.
  • the shaft of the transhumeral glenoid drill just fits within the inner diameter of the transhumeral glenoid drill sleeve 48 and has visible markings on it that allow one to measure the depth of the hole off the distant edge of the transhumeral drill sleeve 48 ( Figures 25a-b).
  • the drill 49 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 glenoid drill guide sleeve 48. Approximately 5 mm is added to the screw length to determine the length of screw used.
  • the drill 49 is then advanced through the far cortex to complete the screw hole in the glenoid.
  • a novel transhumeral screw driver 130 and transhumeral glenoid screw guide sleeve 128 are used to place the above described screws 133, 135.
  • the surgeon removes the inner transhumeral glenoid drill guide sleeve 48 and the transhumeral screwdriver 130 is inserted through the previously positioned transhumeral glenoid screw guide sleeve 128.
  • the screw driver shaft 130 fits snuggly within a transhumeral glenoid screwdriver guide sleeve 128.
  • the screwdriver 130 is then advanced to place a screw 133, 135 through a hole 124 or 126 of the ingrowth shell 120 of a novel glenoid implant 118 into the drilled glenoid bone 22.
  • a central screw 133 is first inserted through a central smooth hole 124 in the glenoid shell 120 to initially compress the ingrowth shell 120 firmly into the glenoid surface 22.
  • the glenoid ingrowth shell 120 is then locked into place by at least one peripheral screw 135, preferably three ( Figures 24a-b, 25a-b). For example, if three peripheral screws 135 are utilized, one is placed anterosuperiorly, one is placed posterosuperiorly, and one is placed inferiorly.
  • the threads of the screws 135 engage the threading of the peripheral holes 126 in the glenoid ingrowth shell 120 as well as the drilled outer cortical surface of the glenoid and scapula.
  • the peripheral holes 126 of the shell direct 120 the screws 135 into a fixed divergent pattern.
  • the modular wear-resistant glenoid surface 122 is inserted though the anterosuperior passage and impacted into the shell 120 with a transhumeral glenoid impactor 90. ( Figures 14a-b, 26a-b) as described previously.
  • the wear-resistant surface 122 of the glenoid implant 118 has a convex surface which mates with the concave side of the protruding surface 119 of the ingrowth shell 120 and forms the articulating surface of the glenoid implant 118.
  • the protruding surface 119 of the ingrowth shell 120 is of thin dimension such that it simultaneously provides 1) fixation to the glenoid bone; 2) an ingrowth surface 120; 3) provides a support surface for the wear-resistant surface 122; and 4) a recessed coupling device which maximizes the thickness of the wear-resistant surface 122 for durability and while still maintaining proper anatomic glenohumeral surface relationships.
  • the wear-resistant surface 122 may include, but is not limited to polyethylene, plastic, ceramic material, metals, and magnetic materials.
  • the wear-resistant surface 122 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 the ingrowth shell 120.
  • the wear-resistant surface 122 of the glenoid implant 118 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.
  • 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.
  • 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 the proximal humerus 20 in accordance with the present .
  • the humerus does not require special positioning.
  • the novel humeral stem 98 is placed in the transhumeral portal 30 from either the first or second anterosuperior passages and the novel modular head 96 is inserted through the anterosuperior passage. The two components 96, 98 are then mated together.
  • the novel humeral implant 94 in accordance with the present invention is modular and includes a humeral surface 96 component, a roughly hemispheric shaped surface with a short central mating device 100, and a transhumeral stem 98 which fills the transhumeral portal 30 ( Figure 15a-b).
  • a novel humeral surface implant that includes only a humeral surface 96, with no stem 98 may be used when warranted.
  • a novel humeral implant 94 with two components 96, 98 is used. The two components, the humeral surface 96 and stem 98, are removably attached to one another.
  • the humeral surface 96 has a coronal radius of curvature and an axial radius of curvature.
  • the humeral surface can be spherical in shape.
  • 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.
  • the humeral surface 96 of the implant 94 also has a depth and thickness.
  • a suitable range for the depth of the humeral implant 94 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.
  • the humeral surface 96 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 shows suitable and preferred ranges of radius of curvature and thickness for the humeral surface of the humeral implant. (See lannotti 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.)
  • the humeral surface of the humeral implant 94 may be spherically shaped or more of an elliptical shape which better approximates the anatomy of a natural humeral head.
  • the humeral surface 96 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 the humeral surface component of the implant that articulates with the glenoid or the glenoid implant, is smooth with a low coefficient of friction.
  • the stem 98 of the modular humeral implant 94 is sized to fit within the transhumeral portal 30 located along the central axis of the neck of the humerus. By fitting, it is meant that the stem 98 fits in a tight manner and is stable in that location. As it is contemplated that the transhumeral portal 30 has a diameter of from 0.1 to 5 cm, the diameter of the stem 98 is also from 0.1 to 5 cm, and is dimensioned to fit within the transhumeral portal 30.
  • the stem 98 may be composed of any suitable materials including, but not limited to titanium, stainless steel, cobalt-chrome alloy.
  • the stem 98 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.
  • the shape of the stem 98 is intended to accommodate the shape of the transhumeral portal 30, therefore it may be round, square, triangular, or any other geometric shape that may comprise the transhumeral portal 30.
  • the main body of the stem 98 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, the stem 98 of the present invention maintains a uniform diameter and is linear from end to end.
  • the stem is dimensioned to sit within the epiphyseal and metaphyseal portions of the humerus.
  • the stem 98 may also contain fins or spikes to aid rotational stability, and it may also possess a bony ingrowth material surface, as describe above.
  • the stem 98 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 this stem 98 be introduced into the transhumeral portal 30 via the lateral incision and advanced through the transhumeral portal 30 to a position that is suitable for mating with the humeral surface 96 which is inserted via the anterosuperior incision, described above. If appropriate, the stem 98 may also be inserted from the articular surface of the proximal humerus
  • the humeral surface 96 and stem 98 of the humeral implant 94 connect to one another via a mating site 100.
  • the humeral surface 96 and stem 94 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 the stem 98 or the humeral surface 96, so long as one male counterpart and one female counterpart are present in the humeral implant 96.
  • the humeral surface 96 component is inserted through the anterosuperior passage and mated with its stem placed through the transhumeral portal 30.
  • the humeral surface 96 and modular stem 98 implant can be cemented or press-fit to the prepared humeral surface and there are many possible variations of the implant 94.
  • Examples A, B, and C are various embodiments of a humeral implant 94 in accordance with the present invention.
  • Example A includes a hemisphere shaped humeral surface 96 and a threaded transhumeral stem 98 ( Figure 16).
  • the humeral surface 96 component is inserted through the anterosuperior passage and is either cemented or press-fit onto the humeral surface 20 and then impacted on the prepared humeral surface against the glenoid.
  • the hemisphere shaped surface 96 is rotationally stabilized with a rod inserted into a hole at a peripheral edge of the hemisphere shaped surface 96 while the threaded humeral stem 98 is advanced through the protective sleeve 15 from the transhumeral portal guide 14 and up the transhumeral portal 30 to engage with the non-articular side of the hemisphere shaped humeral surface 96.
  • the threaded stem 98 has a double pitch with finer pitched but deeper cancellous threads that engage and fill the transhumeral portal 30 and slightly wider pitched more shallow threads on the narrower diameter tip which engages the humeral surface 96 component so as to secure the humeral surface 96 component.
  • removal of the example A implant 94 is conducted by recreating both anterosuperior passages, inserting a driver for the threaded stem 98 through the second anterosuperior passage, inserting a stabilizing rod into a peripheral edge of the humeral surface 96 component from the first anterosuperior passage and backing out the stem through the protective sleeve 15 from the transhumeral portal guide 14.
  • the humeral surface 96 component is then removed by sawing across the base of the humeral surface 96 component at the anatomic neck of the humerus with a power or Gigli saw.
  • Example B includes a similar humeral surface 96 component and a cemented transhumeral stem 98 ( Figures 17a-c).
  • the humeral surface component 96 is inserted through the anterosuperior passage, is either cemented or press-fit onto the prepared humeral surface 20 and impacted on the prepared humeral surface 20 against the glenoid.
  • Another transhumeral stem 98 which possesses the male end of a morse taper is inserted into the female end on the non-articular side of the humeral surface component 96 and impacted against the glenoid.
  • This stem 98 may be press-fit as well as cemented to the bony transhumeral portal.
  • An endcap 106 is threaded into the non-articular side of the stem 98 to assist with later removal of the humeral surface implant 94.
  • a cementation catheter 84 is assembled to an opening in the endcap 106 and cement is injected through the cannulated transhumeral stem 98 exiting holes 99 at its articular end. The cement is injected until it becomes visible around the non-articular end of the stem 98.
  • Example C includes a similar humeral surface 96 component and an inflatable transhumeral stem 98 ( Figures 19a-b) similar to technology used in the FIXION TM 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).
  • the humeral surface component 96 is inserted through the anterosuperior passage and either cemented or press-fit, and further impacted on the prepared humeral surface 20 against the glenoid.
  • transhumeral stem 98 which possesses the male end of a morse taper is inserted into the female end on the non-articular side of the humeral surface 96 component and impacted against the glenoid.
  • the inflatable stem 98 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, the stem 98 is inflated or expanded from its collapsed position with a specialized saline pump to fill the stem 98, within the transhumeral portal 30, and gain purchase.
  • the stem 98 can be removed by deflating it with the same pump and disimpacting the stem 98 from the humeral surface 96 component with a disimpaction sleeve 112.
  • the humeral surface component is removed by sawing across the base of the humeral surface component at the anatomic neck of the humerus with a power or Gigli saw.
  • the present invention is a glenohumeral joint with a transhumeral portal 30 along the central axis of the neck of the humerus and at least one implant.
  • the implant may be a humeral implant 94, a glenoid implant 118 or both.
  • the implants may be conventional implant or novel 94,118 described herein.
  • FIG. 28-33 a method of repairing a rotator cuff, as shown in Figures 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.
  • 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.
  • an insertional guide 134 is inserted with a protective inner sheath 137 ( Figures 28-29).
  • the insertional guide 134 includes a cannulated handle 141 and a cannulated tip 148.
  • the cannulated tip 148 is an elongated rigid tube with a sharp trocar tip 150.
  • the diameter of the rigid tube and trocar tip 150 is slightly larger than that of the suture pin 140, described below, and is approximately 1.0 to 5.0 mm.
  • An inner protective sheath 137 may be used with the insertional guide 134.
  • the inner protective sheath 137 screws into the handle 141 of the insertional guide 134.
  • the inner protective sheath 137 has a handle 135 that acts as a stop and prevents the inner protective sheath 137 from extending further into the insertional guide 134 than the level of the protective sheath handle 135.
  • the inner sheath 137 has a blunt end 139 that extends beyond the level of the sharp trocar 150 of the insertional guide 134, providing a non- sharp surface with which to enter the tissue.
  • the inner protective sheath 137 is removed by unscrewing the handle 135 and sliding it out of the insertional guide 134.
  • an outer protective sheath may be used that extend over the tip of the insertional guide 134 and provides a blunt end as well.
  • the outer protective sheath has a longitudinal split so that it may be peeled off of the insertional guide when the surgeon is ready to use the sharp trocar tip 150 of the insertional guide 134.
  • a bore tip is extended into the lateral humeral cortex under direct or arthroscopic visualization ( Figure 30).
  • An arthroscopic retractor 136 may assist the process.
  • a suture-pin 140 is advanced by a drill through the greater tuberosity of the proximal humerus to exit into an anteromedial supraspinatus rotator cuff footprint.
  • the next step is to reduce the torn edge of the supraspinatus tendon with a soft tissue grasper 138.
  • the suture-pin140 is advanced through the cuff ( Figure 31) and out through the superior soft-tissue and skin using a pin director 142 as needed.
  • the suture-pins 141 may pass through the acromion or deltoid as necessary.
  • the drill is switched to a suture-pin leading tip and the pin component 140 is removed from the body.
  • the pin 140 is cut from the suture 146.
  • the above steps may be repeated as often as necessary to provide sufficient sutures to secure the torn rotator cuff.
  • a tying cannula is then inserted.
  • the sutures 144 are retrieved and passed in modified Mason-Allen fashion if desired, using free needles 140 (open technique) or an arthroscopic suture passing device.
  • the sutures 144 are tied and the tying steps are repeated.
  • the repair may be reinforced with lateral suture anchors as needed before or after tying the transosseous sutures 144 ( Figure 33).
  • the suture-pin device 152 comprises two components, a leading flexible pin 140 and a swedged on suture 144.
  • the suture 144 is preferably a durable size #2 suture 144.
  • the pin 140 has a sharp slightly larger diameter trocar tip 154 on its leading end. The remaining pin 140 has a diameter closer to that of the suture 144.
  • the pin 140 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.
  • the suture 144 is of similar length.

Abstract

A method that does not damage the rotatot cuff is disclosed and a device (152) for shoulder replacement.The method utilizes two ante superior passages to gain access to the glenohumeral joint, without either procedure transaction of the rotator cuff. Also a transhumeral portal is created through the second anteriorsuperior passage for use as a working tunnel. Various medical instruments are used to prepare the passages.

Description

DEVICES AND METHODS USED FOR SHOULDER REPLACEMENT
CLAIM FOR PRIORITY [0001] Applicant claims, under 35 U.S.C §119(e), the benefit of priority of: 1 ) the filing date of August 11 , 2003 of U.S. Provisional Application No. 60/494,289, 2) the filing date of October 8, 2003 of U.S. Provisional Application No. 60/509,655, 3) the filing date of October 16, 2003 of U.S. Provisional Application No. 60/511 ,845, 4) the filing date of November 19, 2003 of U.S. Provisional Application No. 60/523,401 , 5) the filing date of June 15, 2004 of U.S. Provisional Application No. 60/579,893 and 6) the filing date of July 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 [0002] 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 [0003] 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.
[0004] 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.
[0005] 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 NM, Cofield RH, Silbert PL, et al.. Neurologic complications after total shoulder arthroplasty. J Shoulder Elbow Surg 1996;5(1):53-61.). [0006] 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 US Patent 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).
[0007] 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; lannotti 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 EJ, et al. "Anthropometric Study of Normal Glenohumeral Relationships", J Shoulder Elbow Surg 1997;6:105-112; Soslowsky LJ, 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 GR, 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).
[0008] 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 AD, Thomas WH, Scott RD, et al. "Total shoulder arthoplasty versus hemiarthroplasty - indications for glenoid resurfacing", J of Arthroplasty 1990;5(4):329-336; Gartsman GM, Roddey TS, Hammerman SM. J Bone Joint Surg 2000;82A(1):26- 34; Edwards TB, Kadakia NR, 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 RM, Rockwood CA, Esenyel CZ, 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.)
[0009] 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 SG, 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 [0010] 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 [0011] 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 in the process. [0012] 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. [0013] A further advantage is that it spares the rotator cuff tendons and allows for a quicker and more functional recovery [0014] Another aspect of the present invention regards a humeral implant with one component that is removably attached to a second component.
[0015] 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.
[0016] An additional aspect of the invention regards a transhumeral portal sleeve with a bullet shaped guide that has a central cannulation and a peripheral longitudinal cannulation. An advantage is that it safely creates a working portal along the central axis of the proximal humerus. [0017] 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. [0018] 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. [0019] 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. [0020] Another aspect of the invention regards a glenoid surface protective guard that has a protective surface and a removably attached handle.
[0021] In another aspect, a humeral head surface protective guard is provided that has a protective surface and a removably attached handle. [0022] 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. [0023] 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.
[0024] In another aspect, the invention regards a transhumeral glenoid drill with a working surface and a removably attached shaft.
[0025] In another aspect, a transhumeral burr is provided. The transhumeral burr has a high speed working burr surface and a removably attached shaft.
[0026] 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.
[0027] 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.
[0028] In another aspect, a transhumeral cementation device is provided that has a semi-rigid catheter removably attached to a head.
[0029] An additional aspect provides a transhumeral glenoid impactor with a dome-shaped head and a removably attached shaft.
[0030] Another aspect of the invention regards a transhumeral screw driver with a working head and a removably attached shaft.
[0031] 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.
[0032] 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.
[0033] 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 [0034] Figure 1 is a schematic of a patient positioned with fluoroscopy C-arm unit that may be used in conjunction with the present inventions; [0035] Figures 2a and b are plan views of an embodiment of a rotator interval retractor with specialized supraspinatus and subscapularis blades (Figure 2b) in accordance with the present invention; [0036] Figure 3a is a perspective view of an embodiment of a transhumeral portal drill guide and protective sleeve in accordance with the present invention. [0037] Figure 3b is a top plan view of the transhumeral portal drill guide and protective sleeve of Figure 3a; [0038] Figure 3c is a side plan view of the protective sleeve of the transhumeral portal drill guide and sleeve of Figure 3a in accordance with the present invention; [0039] Figure 4a is 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; [0040] Figure 4b is a schematic of the insertion of Figure 4a using an optional embodiment of a radiolucent guide attachment to assist with a guide pin insertion procedure in accordance with the present invention; [0041] Figure 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; [0042] Figure 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; [0043] Figure 7a is 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;
[0044] Figure 7b is a schematic showing a possible way of preparing the humeral head with a transhumeral 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;
[0045] Figure 7c is 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;
[0046] Figure 7d is 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;
[0047] Figure 8a is 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;
[0048] Figure 8b is 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;
[0049] Figure 8c is a perspective view of an embodiment of a head of a glenoid sizing and centering guide in accordance with the present invention; [0050] Figure 9a is 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;
[0051] Figure 9b is 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;
[0052] Figure 10a is 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;
[0053] Figure 10b is 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;
[0054] Figure 10c is 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;
[0055] Figure 11 a is 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;
[0056] Figure 11 b is 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;
[0057] Figure 12a is 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;
[0058] Figure 12b is 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;
[0059] Figure 13a is 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;
[0060] Figure 13b is 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 in Figure 13a;
[0061] Figure 13c is an exploded view of an embodiment of a glenoid cement pressurizer tip of Figures 13a and b in accordance with the present invention;
[0062] Figure 13d is an exploded view of an embodiment of a glenoid cement pressurizer tip for a peg implant of Figures 13 a, b and c in accordance with the present invention;
[0063] Figure 13e is a schematic of a way of utilizing an embodiment of a transhumeral for a novel proximal humeral implant to be used during a surgical procedure in accordance with the present invention;
[0064] Figure 14a a 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;
[0065] Figure 14b is 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;
[0066] Figure 15a is a exploded view of humeral implant in accordance with the present invention; [0067] Figure 15b is a bottom plan view of a humeral implant in accordance with the present invention;
[0068] Figure 16 is a schematic of an embodiment of a humeral surface implant, Example A, in accordance with the present invention;
[0069] Figure 17a is schematic of an embodiment of a humeral surface implant, Example B, in accordance with the present invention;
[0070] Figure 17b is a perspective view of an embodiment of a stem with inner cement channels in accordance with the present invention;
[0071] ' Figure 17c is an perspective view of an embodiment of a endcap of the novel transhumeral stem of Figure 17b in accordance with the present invention;
[0072] Figure 18a is a schematic of a way of removing an embodiment of a humeral surface implant, Step 1 , Example B, during an embodiment of a surgical procedure in accordance with the present invention;
[0073] Figure 18b is a schematic of a way of performing Step 2 of removing an embodiment of a humeral surface implant of Figure 18a during an embodiment of a surgical procedure in accordance with the present invention;
[0074] Figure 19a is a schematic of inserting an embodiment of a humeral surface implant, Example C in accordance with the present invention;
[0075] Figure 19b is a perspective view of a stem of an embodiment of a humeral implant of Figure 19a that is inflatable in accordance with the present invention;
[0076] Figure 20a is 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;
[0077] Figure 20b is a side plan view of a glenoid peg to be used in during a surgical technique in accordance with the present invention; [0078] Figure 20c is a perspective view of a multiple peg glenoid guide of Figure 20a in accordance with the present invention;
[0079] Figure 21 is a side perspective view of an embodiment of a novel glenoid reamer in accordance with the present invention;
[0080] Figure 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;
[0081] Figure 23a is a perspective view of an embodiment of a shell component of a novel glenoid implant in accordance with the present invention;
[0082] Figure 23b is a bottom plan view of a shell component of a novel glenoid implant of Figure 23a;
[0083] Figure 24a is 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;
[0084] Figure 24b is an exploded view of the glenoid drill guide sleeve interfit with the glenoid screw guide sleeve of Figure 24a;
[0085] Figure 25a is 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;
[0086] Figure 25b is an exploded view of the glenoid screw drive sleeve of Figure 25a;
[0087] Figure 26a is 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;
[0088] Figure 26b is an exploded view of the novel glenoid implant of
Figure 26a;
[0089] Figure 27a is a side view of an embodiment of a novel glenoid implant in accordance with the present invention; [0090] Figure 27b is a top plan view of an embodiment of a novel wear-resistant surface the novel glenoid implant of Figure 27a; [0091] Figure 27c is a bottom plan view of an embodiment of the novel wear-resistant surface of novel glenoid implant of Figures 27a and b. [0092] Figure 28 is a perspective view of an embodiment of an insertional guide in accordance with the present invention; [0093] Figure 29 is a perspective view of an embodiment of a flexible inner trocar of an embodiment of an insertion guide in accordance with the present invention; [0094] Figure 30 is a schematic of a way of performing an embodiment of a surgical technique using the insertion guide of Figures 28-29 to bore into a greater tuberosity of proximal humerus in accordance with the present invention; [0095] Figure 31 is a schematic of a way of performing an embodiment of a surgical technique using the insertion guide of Figures 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; [0096] Figure 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 [0097] Figure 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 [0098] 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.
[0099] 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, LF, 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 collinear.
[00100] 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. [00101] Shown in Figures 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, and 26a, 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. [00102] After interscalene regional block and general anesthesia are administered by the anesthesiologist, the patient is positioned in a sitting position with a beach chair postioner as shown in Figure 1. Prior to prepping and draping the patient, a fluoroscopic C- arm machine is positioned accordingly to the patient to obtain a Grashey anteroposterior radiographic view and a modified axiliary lateral view using rotation of the shoulder and slight repositioning of the fluoroscopic machine. After the fluoroscopic views are confirmed, the fluoroscopic machine is backed away from the patient and the shoulder and upper extremity are prepped and draped in sterile fashion. [00103] 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).
[00104] 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 novel rotator interval retractor 5 with specialized supraspinatus 2 and subscapularis 4 blades is inserted (Figure 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. [00105] If necessary, a secondary rotator interval can be made by splitting the subscapularis in line with its fibers. [00106] Note, that the anterosuperior passage descπbed 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.
[00107] The surgical method next involves creating a transhumeral portal. The transhumeral portal 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 portal first involves obtaining an anteroposterior view of the proximal humerus via the fluoroscopic C-arm machine shown in Figure 1. The shoulder is externally rotated between 20 and 40 degrees relative to the plane of the fluoroscope 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 transhumeral portal drill guide 14 and protective sleeve 15 (Figures 3a- c) are inserted down to the anterolateral cortex of the humerus, approximately 1 cm lateral to the biceps groove. Using intraoperative fluoroscopy, a small guide pin 16 is inserted through the transhumeral portal drill guide 14 and sleeve 15 from the anterolateral humeral cortex along the central axis of the humeral neck into the center of the articular surface of the humeral head (Figure 4a). Anteroposterior and modified axillary lateral fluoroscopic images are taken to confirm proper positioning of the guide pin 16. The guide pin 16 is repositioned as necessary until the pin runs centrally through the humeral neck and head on all fluoroscopic views.
[00108] Note, a specialized transhumeral portal drill guide extension 20, 25 may be used to help direct the guide pin 16 into the center of the humeral head (Figure 4a). The transhumeral portal drill guide 14 is a bullet shaped object with multiple longitudinal cannulations to direct guide wires 50. It fits into a protective sleeve 15 which has a handle that is inserted into the second anterosuperior passage to the anterolateral cortex of the proximal humerus 30. This sleeve 15 and guide 24 protect the surrounding soft-tissue and axillary nerve from harm. There is a radiolucent guide attachment 21 which rigidly connects to the handle of the protective sleeve 15 of the transhumeral portal drill guide 14. The radiolucent guide attachment 21 has a radiolucent arm 23 which runs parallel with the cannulations in the transhumeral portal guide 14 and connects to a radiolucent tip 25 which can be any suitable shape, for example, hemispheric (Figure 4b). Once the guide is assembled, the central cannulation of the transhumeral portal guide 14 will direct a guide pin 16 to the center of the hemispheric tip 25. The arm 23 of the guide attachment 21 is sufficiently long to allow significant adjustments in length to accommodate variations in size of the proximal humerus. After the tip 25 of the transhumeral portal drill guide 14 is placed on the humeral surface through the first anterosuperior passage, the radiolucent arm 23 containing a radiopaque reference line can also be aligned with the central axis of the neck of the proximal humerus 22 under fluoroscopy to assist in directing the guide pin 16 to the center of the humeral surface.
[00109] The guide pin 16 is advanced through the transhumeral drill guide 14 and protective sleeve 15 such that it travels toward the glenohumeral joint 7, along the central axis of the neck of the humerus and perpendicular to the humeral joint surface 21. The guide pin 16 is advanced such that the tip of the pin stops right at the humeral joint surface 21. A second pin 18 of equal length is inserted through one of the peripheral holes in the transhumeral portal drill guide 14 and sleeve 15 until it stops at the lateral humeral cortex. Measuring the difference in exposed length between the pins 16, 18 closely estimates the length of the transhumeral portal 30. This measurement assists the surgeon in creating and using the transhumeral portal 30 more safely as well as providing the size of the modular stem 98 used for the proximal humeral implant 94. Then, the second guide pin 18 is advanced into the bone until it reaches the level of the anatomic neck 3 of the humerus. Measuring the difference in exposed length between the pins 16, 18 provides an accurate measurement of humeral head depth (Figure 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.
[00110] Based on the actual measured transhumeral portal 30 length, the transhumeral portal 30 is created by drilling with an approximately 1 centimeter diameter or less cannulated drill bit through the transhumeral portal protective sleeve 15 over the first guide pin 16 from the anterolateral humeral cortex and into the joint (Figure 5). The transhumeral portal 30 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. The first guide pin 16 is removed along with the cannulated drill bit and the second guide pin 18 may remain as a guide for later humeral head resection.
[00111] With the formation of the transhumeral portal 30, the humeral 20 and glenoid 22 surfaces can be prepared as explained hereafter. Note that the order of preparing either the humeral 20 or glenoid 22 surfaces may be altered depending on the proximal humeral 20 bone quality. If there are concerns about the quality of the proximal humeral 20 bone, the humeral surface can be prepared last, after the glenoid, to avoid weakening the proximal humeral bone 20 and jeopardizing the integrity of the transhumeral portal. Also, if hemiarthroplasty is indicated, the humeral surface 21 may solely be prepared and replaced.
[00112] Assuming that it is determined to prepare the humeral surface 21 first, the articular surface of the humeral head 20 may either be resected and replaced to the level of the anatomic neck 3 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 proximal humeral implant. To insert a conventional humeral implant in accordance with the present invention, a preliminary humeral head cut can be made to improve visualization and expedite resection. From the anterosuperior passage previously formed, a long oscillating saw 28 is used to safely resect a limited portion of the humeral head 20 joint surface perpendicular to the portal (Figures 5 and 6). [00113] A transhumeral protective sheath 38 used during the procedure of the present invention is then threaded or press-fit into the transhumeral portal 30 through the second anterosuperior passage using the transhumeral portal protective sleeve 15 to safely direct it. It is inserted to the level of the anatomic neck 3 of the proximal humerus 20 in preparation for a conventional humeral implant or to the level of the joint surface 21 for a novel humeral implant (Figure 7a). An embodiment of the transhumeral protective sheath 38 of the present invention provides protection for the bone within which the transhumeral portal sits. The transhumeral sheath 38 is a tube of such shape, inner and outer diameter, and thickness such that it interfits securely within the transhumeral portal 30 along the central axis of the neck 3 of the humerus 20, allows easy passage and use of all transhumeral instruments and sleeves while protecting the remaining bone of the proximal humerus from harm. The transhumeral sheath 38 may be metal, plastic, or other semi-rigid, wear-resistant material and may be slid or threaded into the transhumeral portal.
[00114] Next, a transhumeral reamer shaft 34 is placed through the protective sheath 38 and assembled in the joint with the appropriately sized modular humeral reamer head 36 inserted through the anterosuperior passage (Figures 7a-d). A novel transhumeral humeral reamer 32, in one embodiment of the present invention, includes a reaming surface 36 and a transhumeral shaft 34. The transhumeral reamer 32 is designed so that the shaft 34 interfits securely within the transhumeral portal 30, and more specifically, within the transhumeral protective sheath 38 within the transhumeral portal 30, such that there is no shaking or toggling while the reamer is being used. Therefore the diameter of the shaft 34 is from 0.1 to 5 cm and slightly smaller than the inner diameter of the transhumeral protective sheath 38 through which it traverses. For a conventional humeral prosthesis, a flat reaming head surface 36 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 neck 3 of the humerus. For a novel humeral implant 94, a hemispherically shaped reaming surface 36, sized similarly to a novel humeral surface 96 implant component is used, having similar depth and radius of curvature (Figure 7c). The hemispherically shaped reaming surface 36 removes a minimal amount of bone. The amount of bone removed is roughly equivalent to the thickness of the humeral surface 96 component of the implant.
[00115] A protective guard 40 may be placed over the glenoid through the anterosuperior passage during reaming (Figure 7d). The protective guard 40 is introduced through the first anterosuperior passage by a handle 44. In one embodiment of the present invention, the guard 40 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. The handle 44 is removable and can be attached to the guide at different positions to allow it to be inserted from variable angles through the anterosuperior passage. [00116] After the guard 40 is in place, the orthopaedic surgeon grasps the protective sheath 38 and pulls the running reamer 32 back onto the humeral head until it cuts to the level of the anatomic neck 3 for a conventional humeral implant (Figure 7a). Live fluoroscopy may be used to assist with making the cut and insuring that the reamer stays parallel to the second guide pin 18 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. [00117] To insert a novel proximal humeral implant 94, the transhumeral protective sheath 38 and reamer shaft 34 are inserted as described above (Figures 7a-d). Alternatively, the appropriate size novel modular humeral reamer head 36 is inserted through the anterosuperior passage into the joint and assembled with the transhumeral shaft 34. A protective guard 40 may be placed over the glenoid 22 through the anterosuperior passage during reaming. Again, the orthopaedic surgeon grasps the protective sheath 38 and pulls the running reamer 32 back onto the humeral head until the novel humeral reamer has removed just enough bone to restore the proper humeral head dimensions with the reamer 32 (Figure 7b). Openings 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 the reamer 32 stays parallel to the second guide pin 18 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. [00118] After the reamer 32 has prepared the humeral head, either for a conventional or a novel proximal humeral implant 94, the glenoid 22 of the shoulder joint is then prepared for the placement of a glenoid implant 118 (Figure 8a). Any remaining soft-tissue obstructing the glenoid surface 22 should be excised. The humerus is abducted, rotated, and laterally distracted to direct the working transhumeral portal 30 such that its path lies perpendicular to and centered on the glenoid surface 22. A glenoid sizing and centering hole guide 46 is placed from the anterosuperior passage (Figure 8b-c). In another embodiment of the present invention, a glenoid sizer and centering hole guide 46 includes a working surface 52 and a handle 53. The guide 46 is shaped and sized according to the shape and size of the glenoid 22 to be prepared. The working surface 52 is inserted through the first anterosuperior passage by its handle 53. The handle 53 is removable and can be attached to the working surface 52 at different positions to allow it to be inserted from variable angles through the anterosuperior passage. The working surface is approximately 0.1 to 10 mm thick and flat. [00119] Utilizing the appropriately sized glenoid sizing and centering guide 46, a transhumeral guide wire 50 is inserted into the transhumeral portal 30 through the transhumeral protective sheath 38 to allow a drill 49 to drill a centering hole on the glenoid surface 22 regardless of whether a conventional or novel humeral implant is being inserted (Figures 8a-b). . After the centering hole has been started, the guide wire 50 is backed up to allow the removal of the glenoid sizing and centering guide 46. A cannulated flat or hemispherical humeral head guard 64, followed by a cannulated glenoid surface cutting reamer head 60, is inserted through the anterosuperior passage and the guidewire 50 is advanced through cannulations in both instruments back into the centering hole in the glenoid.
[00120] In another embodiment of the present invention, a humeral head surface protective guard 64 may be used (Figures 9a-b). This protective guard 64 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. The protective guard 64 is inserted via the first anterosuperior passage and fits over the humeral surface 20 and the shaft 62 of the transhumeral glenoid reamer 58. The shaft 62 of the transhumeral glenoid reamer 58, described below, passes through a central cannulation of the guard 64 to prepare the glenoid 22. The humeral head surface protective guard 64 is sized according to need, such as small, medium, and large. The guard 64 is approximately 0.1 to 2.0 mm thick. Optionally, the guard 64 may be used with a handle.
[00121] The present invention also provides a transhumeral glenoid reamer 58 (Figures 9a-b, 21 , 22, 23a-b). The glenoid reamer 58 has a shaft 62 and a working head 60. The shaft 62 is designed to interfit securely within the transhumeral portal 30, and more specifically, within the transhumeral protective sheath 38 within the transhumeral portal 30, such that there is no shaking or toggling of the shaft 62 within the transhumeral portal 30 while the transhumeral glenoid reamer 58 is in use. Therefore, the outer diameter of the shaft 62 is approximately 0.1 to 5 cm, and slightly less than the inner diameter of the transhumeral protective sheath 38 within which the shaft 62 is used. The working glenoid reamer heads 60 and shafts 62 are cannulated to fit over a central glenoid guide wire 50. 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. [00122] For a conventional glenoid implant 115 (shown in Figure 14a), a nearly flat, slightly convex, reaming head surface 60 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. The flat reaming head 60 removes a minimal thickness of bone. The same flat reaming head 60 as used for a conventional glenoid implant may also be used before inserting the multiple pegged glenoid implant. [00123] For a novel glenoid implant 118, the glenoid reaming head includes a peripherally flat, less aggressive surface 116 and a centrally raised surface 114 which has a more aggressive reaming surface (Figure 23a-b). The centrally raised surface 114 may be a convex dome, a square, triangle, pyramid, or any other shape that matches the protruding surface of the novel glenoid implant 118 to be implanted within the glenoid, as described below. The peripheral glenoid reaming surface 116 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, the central reaming surface 114 removes a spherically shaped area of bone such that a central concave glenoid surface is created which fits an ingrowth shell component 120 of a novel glenoid implant 118 in accordance with the present invention. The concavity is slightly undersized to allow a pressfit of the ingrowth shell 120. [00124] To prepare the glenoid for a conventional prosthesis, the cannulated transhumeral glenoid reamer shaft 62 is positioned over the guidewire 50 and through the transhumeral protective sheath 38 from the second anterosuperior passage. The transhumeral reamer shaft 62 is assembled in the shoulder joint with its glenoid surface cutting reamer head 60 and the reamer 58 is advanced along the guide wire 50 removing as little bone as possible to correct the profile of the worn glenoid and create the proper radius of curvature on the surface to match that of the non-articular surface of the conventional glenoid implant. The guide wire 50 must be inserted initially in the proper orientation to direct the cut appropriately. There is also an optional glenoid cutting surface head 60 with a central peg that can be used without the guide wire 50 and can be inserted directly into the glenoid centering hole while the surgeon runs the transhumeral glenoid reamer 58 (Figures 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.
[00125] The glenoid 22 can be prepared for implantation of either a conventional pegged or keeled glenoid implant, a multiple peg glenoid implant (Figure 20b), or a novel glenoid implant 118. In the case of implanting a conventional peg or keel glenoid implant, the appropriately sized (according to the previously used glenoid sizer and centering hole guide), peg glenoid or keel guide 68 is inserted through the anterosuperior passage and centered by placing its peg 72 into the previously created glenoid centering hole (Figure 10a). The transhumeral glenoid drill 66 is placed through the transhumeral protective sheath 38 within the transhumeral portal 30 from the second anterosuperior passage. In one embodiment of the present invention, a glenoid keel drill guide 68 has a working surface 69 and a handle 70. The working surface 69 is introduced via the first anterosuperior passage by its handle 70. The handle 70 is removable and can be attached to the guide 68 at different positions to allow it to be inserted from variable angles through the anterosuperior passage. This drill guide 68 is shaped and sized similarly to the glenoid sizing and centering hole guide 46, discussed above. The working surface 69 of the guide 68 has a central peg 72 that fits into a centering hole in the glenoid bone. The drill guide 68 for the conventional keel glenoid implant has two converging holes, one superior and one inferior, directed toward each other to direct a transhumeral glenoid drill 66 to cut a keel shape into the glenoid bone (Figure 10b).
[00126] The previously mentioned glenoid peg drill guide 68 has a working surface 69 and a handle 70. The working surface 69 is inserted through the first anterosuperior passage by its handle 70. The handle 70 is removable and can be attached to the guide surface 69 at different positions to allow it to be inserted from variable angles through the anterosuperior passage. This drill guide 68 is sized and shaped similarly to the glenoid sizing and centering hole guide 46, discussed above. The working surface 69 of the guide 68 has a central peg 72 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 drill 66 for pegs in a glenoid. [00127] In one embodiment, the above-mentioned transhumeral keel/peg glenoid drill 66 has a working surface 67 and a removably attached transhumeral shaft 65. The working surface 67 is a drill bit (or tip) for drilling holes in the glenoid for keels or pegs of the conventional glenoid implant. The drill bit 67 (or tip) is larger for drilling holes for a keel or a peg than a bit used for drilling holes for screws. [00128] To further prepare the glenoid surface for a conventional glenoid implant, the humerus is positioned and translated such that the transhumeral keel/glenoid glenoid drill 66 is maintained perpendicular to the glenoid peg/keel guide surface 69. With the gleonid drill introduced through the the transhumeral protective sheath 38 of the transumeral portal 30 and the glenoid drill guide 68 postioned from the first anterosuperior passage, holes are drilled into the glenoid (Figures 10a- c). To prepare the glenoid to accept a keel glenoid implant, the transhumeral burr 74 is inserted into the transhumeral portal 30 through the transhumeral protective sheath 38 and used to connect the drilled holes in the glenoid surface (Figures 11a-b). [00129] In one embodiment, the transhumeral burr 74 has a transhumeral shaft 75 removably attached to a high speed burr tip 73 with different sizes used for cutting holes in a glenoid, particularly for a keel.
[00130] A modular keel punch 76 is used to finish the glenoid keel cut. In an embodiment, where a glenoid keel punch 76 is used, the keel punch 76 has a working surface 77 and a removably attached transhumeral shaft 78 (Figures 12a-b). The working surface 77 (also referred to as a punch head,) is inserted through the first anterosuperior passage and the shaft 78 is introduced through the second anterosuperior passage and the transhumeral protective sheath 38. The shaft 78 is assembled with the working surface 77 in the glenohumeral joint. The working surface 77 is a head shaped like a keel with cutting teeth to cut a keel shape into a glenoid surface 22. The punch 76 is struck with a hammer to complete the keel shaped cut into the glenoid (Figures 12a-b). [00131] The humeral head and glenoid trial implants are inserted through the anterosuperior passage and the rotator interval retractor 5 (Figure 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.
[00132] Next, the glenoid 22 is prepared to affix its conventional implant 115 using transhumeral cementation tools 80 (Figures 13a-e). A transhumeral irrigation and suction catheter is inserted into the transhumeral portal 30 through the novel transhumeral protective sheath 38 and used to irrigate and suck the prepared glenoid 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 transhumeral protective sheath 38 in the transhumeral portal 30 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. [00133] 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 a transhumeral cementation catheter 84 is inserted through the transhumeral portal 30 and protective sheath 38 to place the cement.
[00134] Note that the above-described transhumeral cementation tool 80 includes a modular with keel glenoid and peg glenoid cement pressurizer head 86 and cementation catheter 84. The transhumeral cementation catheter 84 includes semi-rigid tubing which connects to a conventional cement gun 104 to deliver cement to the site of implant fixation to bone. The head 86 includes a keel glenoid or peg glenoid cement pressurizer tip 82 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 the glenoid surface 22. The pressurizer head 86 are shaped similar to a glenoid with a smaller keel or single peg. The radius of curvature of the periphery of the tip 82 matches that of the reamed bony glenoid surface 22 to help seal the hole during cement insertion These heads 86 are inserted through the first anterosuperior passage by their handles 88 and are attached to the transhumeral cementation catheter 84 within the glenohumeral joint 7 to pressurize the cement in the glenoid holes. The handle 88 is removable and can be attached to the head 86 at different positions to allow it to be inserted from variable angles through the anterosuperior passage. The cementation head 86 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. A cement pressurizer tip 82 may be inserted into the joint through the anterosuperior passage and assembled with the transhumeral cementation catheter 84. There are different pressurizer tip82 to match either the pegged or keeled glenoid. The conventional glenoid implant 115 is inserted through the anterosuperior passage, is seated and held in place until the cement dries with a modular transhumeral glenoid impactor 90. Excess cement is removed and the joint is irrigated
[00135] The transhumeral glenoid impactor 90 includes a transhumeral shaft 92 which removably attaches to a working head 91. The working head 91 has a convex surface that approximates the radius of curvature of the articular surface of the glenoid implant. The shaft 92 is introduced through transhumeral protective sheath 38 within the . transhumeral portal 30. The working head 91 is introduced through the first anterosuperior passage and mated with the transhumeral shaft 92. Force can then be applied to the handle 89 of the impactor 90 to seat the glenoid implant 115.
[00136] In accordance with an embodiment of the present invention, a multiple peg glenoid implant 115 (Figures 20a-c) or a novel modular ingrowth glenoid implant 118 (Figures 23a-b, 27a-c) can also be inserted. [00137] After the glenoid surface 22 has been reamed by a glenoid reamer 58 as described previously, the multiple glenoid pegs 61 can be introduced with a novel multiple peg guide 67 through the anterosuperior passage and inserted into the prepared surface of the glenoid 22 using a transhumeral insertor device 79 (Figure 20a). In another embodiment, a multiple peg glenoid insertor 79 and insertor guide 67 are used. The multiple peg glenoid insertor guide 67 includes a handle 73 and a guiding surface 71. The guiding surface 71 is sized and shaped as the glenoid peg drill guide 67 discussed above. The guide 67 is introduced via the first anterosuperior passage and holds multiple pegs 61 to be inserted into the glenoid 22. The guiding sur ace 71 of the guide 67 controls the depth and location of insertion of the multiple pegs 61. [00138] The multiple peg glenoid insertor 79 is inserted via the second anterosuperior passage and through the transhumeral protective sheath 38 in the transhumeral portal 30. It is used to engage the pegs 61 located within the multiple peg insertor guide working surface 71 and then drives them into the glenoid one at a time. The insertor 79 stops when it hits the guide surface 71 to control the depth of peg 61 insertion. Drilling pilot holes through a separate guide with a special transhumeral drill can precede this step. The guide surface, preloaded with the implant pegs 61 controls the position, direction and depth of peg 61 insertion. The guide surface 71 has a protruding centering peg 61 which fits into the centering hole of the glenoid to help center and position the guide surface 71.
[00139] After the multiple peg prosthesis is implanted, trialing of a conventional or novel humeral implant can be performed as described previously.
[00140] Alternatively, a novel ingrowth glenoid implant 118 can be implanted after reaming the glenoid with a novel transhumeral glenoid reamer 57 as described previously. The novel modular ingrowth glenoid implant 118 has an ingrowth shell 120 and modular wear-resistant articulating surface 122 (Figures 23a-b, 27a-c) [00141] The ingrowth shell 120 of the glenoid implant 118 is a cannulated shallow shell with a protruding surface that sits within the concavity of the reamed glenoid surface. The protruding surface is surrounded by a flat outer surface 121 (or brim). The protruding surface 119 may be any shape such as a square, pyramidal, hemispheric, triangular or any other suitable shape. The protruding surface protrudes into the glenoid to a specified depth. The depth is such that it is enough for the ingrowth shell 120 to be securely seated within the glenoid and for the wear-resistant surface 122 to fit therein (as described below) and yet not so deep that a large amount of subchondral bone must be reamed from the glenoid. Preferably, the shape of the previously described novel glenoid reamer 57 is the same as the shape of the protruding surface 119 of the ingrowth shell 120 such that there will be a secure fit when the ingrowth shell 120 is seated within the glenoid 22. As the ingrowth shell 120 is pressed into the glenoid, the flat surface (or annular brim) 121 of the ingrowth shell 120 also makes contact with the peripheral glenoid surface 22, and in fact, provides a stopping point of insertion. The ingrowth shell 120 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 protruding surface
119 of the annular brim 121 of the shell 120 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. The ingrowth shell 120 has a thickness of 0.1 to 10 mm, preferably from 0.1 to 2 mm. The ingrowth shell 120 has holes for fixation. These holes may be central 124 and peripheral 126 and may further be smooth, threaded or a combination thereof. In one embodiment, a shell has a central hole 124 and multiple peripheral holes 126, for example three peripheral holes 126. The central hole 124 is preferably smooth and the peripheral holes 126 are preferably threaded.
[00142] After reaming, the ingrowth shell 120 is inserted through the anterosuperior passage and impacted into the concavity (which matches the shape of the reamer head 60 and that of the protruding surface 119 of the ingrowth shell 120 to be implanted,) of the reamed glenoid with a transhumeral impacting device 90. The concavity is slightly undersized to attain a tight fit upon impaction. The ingrowth glenoid shell 120 is then fixed to the glenoid 22 using screws 133, 135. In one embodiment, a central compression screw 133 is first used to compress the ingrowth shell into the concavity created in the glenoid and affix the ingrowth shell
120 to the glenoid and then fixed angle peripheral screws 135 are used to lock the ingrowth shell into place.
[00143] The transhumeral glenoid drill 49 is used along with a transhumeral glenoid drill sleeve 48 (Figures 24a-b) to make the holes for the glenoid screws 133, 135. The transhumeral glenoid drill sleeve 48 fits into a transhumeral glenoid screw sleeve 128 which fits into the protective transhumeral sheath 38 in the transhumeral portal 30. The drill sleeve 128 mates with the holes 124, 126 in the ingrowth shell component 120 of the novel glenoid implant to direct the drill 49 in the proper orientation. The shaft of the transhumeral glenoid drill just fits within the inner diameter of the transhumeral glenoid drill sleeve 48 and has visible markings on it that allow one to measure the depth of the hole off the distant edge of the transhumeral drill sleeve 48 (Figures 25a-b). The drill 49 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 glenoid drill guide sleeve 48. Approximately 5 mm is added to the screw length to determine the length of screw used. The drill 49 is then advanced through the far cortex to complete the screw hole in the glenoid.
[00144] In one embodiment of the present invention, a novel transhumeral screw driver 130 and transhumeral glenoid screw guide sleeve 128 are used to place the above described screws 133, 135. After drilling, the surgeon removes the inner transhumeral glenoid drill guide sleeve 48 and the transhumeral screwdriver 130 is inserted through the previously positioned transhumeral glenoid screw guide sleeve 128. The screw driver shaft 130 fits snuggly within a transhumeral glenoid screwdriver guide sleeve 128. The screwdriver 130 is then advanced to place a screw 133, 135 through a hole 124 or 126 of the ingrowth shell 120 of a novel glenoid implant 118 into the drilled glenoid bone 22. As briefly described above, a central screw 133 is first inserted through a central smooth hole 124 in the glenoid shell 120 to initially compress the ingrowth shell 120 firmly into the glenoid surface 22. The glenoid ingrowth shell 120 is then locked into place by at least one peripheral screw 135, preferably three (Figures 24a-b, 25a-b). For example, if three peripheral screws 135 are utilized, one is placed anterosuperiorly, one is placed posterosuperiorly, and one is placed inferiorly. The threads of the screws 135 engage the threading of the peripheral holes 126 in the glenoid ingrowth shell 120 as well as the drilled outer cortical surface of the glenoid and scapula. The peripheral holes 126 of the shell direct 120 the screws 135 into a fixed divergent pattern.
[00145] After the glenoid ingrowth shell 120 is well fixed, the modular wear-resistant glenoid surface 122 is inserted though the anterosuperior passage and impacted into the shell 120 with a transhumeral glenoid impactor 90. (Figures 14a-b, 26a-b) as described previously. [00146] The wear-resistant surface 122 of the glenoid implant 118 has a convex surface which mates with the concave side of the protruding surface 119 of the ingrowth shell 120 and forms the articulating surface of the glenoid implant 118. The protruding surface 119 of the ingrowth shell 120 is of thin dimension such that it simultaneously provides 1) fixation to the glenoid bone; 2) an ingrowth surface 120; 3) provides a support surface for the wear-resistant surface 122; and 4) a recessed coupling device which maximizes the thickness of the wear-resistant surface 122 for durability and while still maintaining proper anatomic glenohumeral surface relationships. The wear-resistant surface 122 may include, but is not limited to polyethylene, plastic, ceramic material, metals, and magnetic materials. At a minimum, the wear-resistant surface 122 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 the ingrowth shell 120. The wear-resistant surface 122 of the glenoid implant 118, 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. [00147] 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- retaining rotator interval retractor 5 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 the proximal humerus 20 in accordance with the present . [00148] For the novel humeral implant 94, the humerus does not require special positioning. After humeral trialing, the novel humeral stem 98 is placed in the transhumeral portal 30 from either the first or second anterosuperior passages and the novel modular head 96 is inserted through the anterosuperior passage. The two components 96, 98 are then mated together.
[00149] The novel humeral implant 94 in accordance with the present invention is modular and includes a humeral surface 96 component, a roughly hemispheric shaped surface with a short central mating device 100, and a transhumeral stem 98 which fills the transhumeral portal 30 (Figure 15a-b). Alternatively, a novel humeral surface implant that includes only a humeral surface 96, with no stem 98 may be used when warranted. Preferably, however, a novel humeral implant 94 with two components 96, 98 is used. The two components, the humeral surface 96 and stem 98, are removably attached to one another. The humeral surface 96 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. The humeral surface 96 of the implant 94 also has a depth and thickness. A suitable range for the depth of the humeral implant 94 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. The humeral surface 96 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
Figure imgf000039_0001
Table 1 shows suitable and preferred ranges of radius of curvature and thickness for the humeral surface of the humeral implant. (See lannotti 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.)
[00150] The humeral surface of the humeral implant 94 may be spherically shaped or more of an elliptical shape which better approximates the anatomy of a natural humeral head. The humeral surface 96 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 the humeral surface component of the implant that articulates with the glenoid or the glenoid implant, is smooth with a low coefficient of friction. [00151] The stem 98 of the modular humeral implant 94 is sized to fit within the transhumeral portal 30 located along the central axis of the neck of the humerus. By fitting, it is meant that the stem 98 fits in a tight manner and is stable in that location. As it is contemplated that the transhumeral portal 30 has a diameter of from 0.1 to 5 cm, the diameter of the stem 98 is also from 0.1 to 5 cm, and is dimensioned to fit within the transhumeral portal 30. The stem 98 may be composed of any suitable materials including, but not limited to titanium, stainless steel, cobalt-chrome alloy. The stem 98 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 the stem 98 is intended to accommodate the shape of the transhumeral portal 30, therefore it may be round, square, triangular, or any other geometric shape that may comprise the transhumeral portal 30. The main body of the stem 98 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, the stem 98 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 the humeral surface 96, the stem 98 may also contain fins or spikes to aid rotational stability, and it may also possess a bony ingrowth material surface, as describe above.
[00152] The stem 98 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 this stem 98 be introduced into the transhumeral portal 30 via the lateral incision and advanced through the transhumeral portal 30 to a position that is suitable for mating with the humeral surface 96 which is inserted via the anterosuperior incision, described above. If appropriate, the stem 98 may also be inserted from the articular surface of the proximal humerus
[00153] The humeral surface 96 and stem 98 of the humeral implant 94 connect to one another via a mating site 100. The humeral surface 96 and stem 94 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 the stem 98 or the humeral surface 96, so long as one male counterpart and one female counterpart are present in the humeral implant 96.
[00154] The humeral surface 96 component is inserted through the anterosuperior passage and mated with its stem placed through the transhumeral portal 30. The humeral surface 96 and modular stem 98 implant can be cemented or press-fit to the prepared humeral surface and there are many possible variations of the implant 94. Examples A, B, and C are various embodiments of a humeral implant 94 in accordance with the present invention. Example A includes a hemisphere shaped humeral surface 96 and a threaded transhumeral stem 98 (Figure 16). The humeral surface 96 component is inserted through the anterosuperior passage and is either cemented or press-fit onto the humeral surface 20 and then impacted on the prepared humeral surface against the glenoid. The hemisphere shaped surface 96 is rotationally stabilized with a rod inserted into a hole at a peripheral edge of the hemisphere shaped surface 96 while the threaded humeral stem 98 is advanced through the protective sleeve 15 from the transhumeral portal guide 14 and up the transhumeral portal 30 to engage with the non-articular side of the hemisphere shaped humeral surface 96. The threaded stem 98 has a double pitch with finer pitched but deeper cancellous threads that engage and fill the transhumeral portal 30 and slightly wider pitched more shallow threads on the narrower diameter tip which engages the humeral surface 96 component so as to secure the humeral surface 96 component. Should it be necessary, removal of the example A implant 94 is conducted by recreating both anterosuperior passages, inserting a driver for the threaded stem 98 through the second anterosuperior passage, inserting a stabilizing rod into a peripheral edge of the humeral surface 96 component from the first anterosuperior passage and backing out the stem through the protective sleeve 15 from the transhumeral portal guide 14. The humeral surface 96 component is then removed by sawing across the base of the humeral surface 96 component at the anatomic neck of the humerus with a power or Gigli saw.
[00155] Example B includes a similar humeral surface 96 component and a cemented transhumeral stem 98 (Figures 17a-c). Again, the humeral surface component 96 is inserted through the anterosuperior passage, is either cemented or press-fit onto the prepared humeral surface 20 and impacted on the prepared humeral surface 20 against the glenoid. Another transhumeral stem 98 which possesses the male end of a morse taper is inserted into the female end on the non-articular side of the humeral surface component 96 and impacted against the glenoid. This stem 98 may be press-fit as well as cemented to the bony transhumeral portal. An endcap 106 is threaded into the non-articular side of the stem 98 to assist with later removal of the humeral surface implant 94. To fix with cement, a cementation catheter 84 is assembled to an opening in the endcap 106 and cement is injected through the cannulated transhumeral stem 98 exiting holes 99 at its articular end. The cement is injected until it becomes visible around the non-articular end of the stem 98. 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 shaft into the stem 98, drilling out the cement-implant interface with a coring reamer over the stem 98, and disimpacting the stem 98 from the humeral surface component 96 with a disimpaction sleeve 112 (Figures 18a-b). The humeral surface component 96 is removed by sawing across the base of the humeral surface component 96 at the anatomic neck of the humerus with a power or Gigli saw.
[00156] Example C includes a similar humeral surface 96 component and an inflatable transhumeral stem 98 (Figures 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, the humeral surface component 96 is inserted through the anterosuperior passage and either cemented or press-fit, and further impacted on the prepared humeral surface 20 against the glenoid. Another transhumeral stem 98 which possesses the male end of a morse taper is inserted into the female end on the non-articular side of the humeral surface 96 component and impacted against the glenoid. The inflatable stem 98 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, the stem 98 is inflated or expanded from its collapsed position with a specialized saline pump to fill the stem 98, within the transhumeral portal 30, and gain purchase. The stem 98 can be removed by deflating it with the same pump and disimpacting the stem 98 from the humeral surface 96 component with a disimpaction sleeve 112. The humeral surface component is removed by sawing across the base of the humeral surface component at the anatomic neck of the humerus with a power or Gigli saw.
[00157] 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. [00158] In yet another embodiment, the present invention is a glenohumeral joint with a transhumeral portal 30 along the central axis of the neck of the humerus and at least one implant. The implant may be a humeral implant 94, a glenoid implant 118 or both. The implants may be conventional implant or novel 94,118 described herein. [00159] In an alternative embodiment of the present invention, there is provided a method of repairing a rotator cuff, as shown in Figures 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. [00160] In one embodiment of the rotator cuff repair method, an insertional guide 134 is inserted with a protective inner sheath 137 (Figures 28-29). The insertional guide 134 includes a cannulated handle 141 and a cannulated tip 148. The cannulated tip 148 is an elongated rigid tube with a sharp trocar tip 150. The diameter of the rigid tube and trocar tip 150 is slightly larger than that of the suture pin 140, described below, and is approximately 1.0 to 5.0 mm. An inner protective sheath 137 may be used with the insertional guide 134. The inner protective sheath 137 screws into the handle 141 of the insertional guide 134. The inner protective sheath 137 has a handle 135 that acts as a stop and prevents the inner protective sheath 137 from extending further into the insertional guide 134 than the level of the protective sheath handle 135. The inner sheath 137 has a blunt end 139 that extends beyond the level of the sharp trocar 150 of the insertional guide 134, providing a non- sharp surface with which to enter the tissue. When the surgeon is prepared to use the sharp trocar tip 150 of the insertional guide 134, the inner protective sheath 137 is removed by unscrewing the handle 135 and sliding it out of the insertional guide 134. Optionally, an outer protective sheath may be used that extend over the tip of the insertional guide 134 and provides a blunt end as well. In this embodiment, the outer protective sheath has a longitudinal split so that it may be peeled off of the insertional guide when the surgeon is ready to use the sharp trocar tip 150 of the insertional guide 134. A bore tip is extended into the lateral humeral cortex under direct or arthroscopic visualization (Figure 30). An arthroscopic retractor 136 may assist the process. Directed by an insertional guide 134, a suture-pin 140 is advanced by a drill through the greater tuberosity of the proximal humerus to exit into an anteromedial supraspinatus rotator cuff footprint. The next step is to reduce the torn edge of the supraspinatus tendon with a soft tissue grasper 138. The suture-pin140 is advanced through the cuff (Figure 31) and out through the superior soft-tissue and skin using a pin director 142 as needed. The suture-pins 141 may pass through the acromion or deltoid as necessary. The drill is switched to a suture-pin leading tip and the pin component 140 is removed from the body. The pin 140 is cut from the suture 146. The above steps may be repeated as often as necessary to provide sufficient sutures to secure the torn rotator cuff. For the arthroscopic technique, a tying cannula is then inserted. The sutures 144 are retrieved and passed in modified Mason-Allen fashion if desired, using free needles 140 (open technique) or an arthroscopic suture passing device. The sutures 144 are tied and the tying steps are repeated. The repair may be reinforced with lateral suture anchors as needed before or after tying the transosseous sutures 144 (Figure 33). [00161] The suture-pin device 152 comprises two components, a leading flexible pin 140 and a swedged on suture 144. The suture 144 is preferably a durable size #2 suture 144. The pin 140 has a sharp slightly larger diameter trocar tip 154 on its leading end. The remaining pin 140 has a diameter closer to that of the suture 144. The pin 140 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. The suture 144 is of similar length.
[00162] 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.

Claims

I CLAIM 1. A method for shoulder replacement comprising: creating a portal along a central axis of a neck of a proximal humerus associated with a shoulder of a patient; and implanting an implant in said shoulder without passing a component of said implant through said portal.
2. The method of claim 1 wherein said portal, is transhumeral in that it traverses a section of said proximal humerus within said neck of said proximal humerus and is perpendicular to a center of a humeral joint surface.
3. The method of claim 1 wherein a rotator cuff associated with said shoulder is not transected during said method.
4. The method of claim 3 further comprising forming an anterosuperior passage to access a glenohumeral joint associated with said shoulder.
5. The method of claim 4 further comprising exposing said glenohumeral joint via said anterosuperior passage.
6. The method of claim 4 further comprising preparing a glenoid surface associated with said shoulder via said anterosuperior passage.
7. The method of claim 4 further comprising preparing a humeral surface and a glenoid surface associated with said shoulder via said anterosuperior passage.
8. The method of claim 4 wherein said implant is a humeral implant and said humeral implant is inserted into said shoulder via said anterosuperior passage.
9. The method of claim 4 wherein said implant is a glenoid implant and said glenoid implant is inserted via said anterosuperior passage.
10. The method of claim 4 wherein said implant is a humeral implant and said method further comprises inserting said humeral implant and a glenoid implant via said anterosuperior passage.
11. The method of claim 10 further comprising forming a second anterosuperior passage to said glenohumeral joint, wherein said second anterosuperior passage is located in a position that is inferolateral to said anterosuperior passage and is utilized to gain access to an anterolateral bony cortex of said proximal humerus in line with said central axis of said neck of said proximal humerus.
12. The method of claim 11 wherein said second anterosuperior passage to said glenohumeral joint is utilized to create said portal.
13. The method of claim 12 further comprising preparing a glenoid surface and a humeral surface associated with said shoulder to receive said implant.
14. The method of claim 13 wherein said glenoid surface is prepared to receive a glenoid implant and said humeral surface is prepared to receive a humeral implant.
15. The method of claim 14 wherein said implant is a humeral implant that engages said prepared humeral surface.
16. The method of claim 15 further comprising implanting a glenoid implant that engages said prepared glenoid surface.
17. The method of claim 1 wherein said portal defines a circular opening having a diameter of about 0.1cm to about 5.0 cm.
18. The method of claim 17 wherein said diameter is about 0.1 to 1.0 cm.
19. The method of claim 18 wherein said diameter is about 0.5 to about 1.0 cm.
20. The method of claim 3 further comprising forming an arthroscopic passage and subsequently performing shoulder joint contracture releases, capsular plication, osteophyte removal, and glenoid exposure via said arthroscopic passage.
21. The method of claim 4 further comprising performing shoulder joint contracture releases, capsular plication, osteophyte removal, and glenoid exposure via said anterosuperior passage.
22. The method of claim 4 wherein said forming said anterosuperior passage comprises forming an anterosuperior shoulder skin incision, a deltoid interval or deltoid split, forming a superficial passage, and forming a rotator cuff sparing deep passage.
23. The method of claim 22 wherein said rotator cuff sparing deep passage creates an opening at natural intervals or longitudinal splits in musculotendinous units of a rotator cuff associated with said shoulder to gain exposure of an articular surface of said glenohumeral joint.
24. The method of claim 23 further comprising holding open said longitudinal splits with a rotator cuff interval self-retaining retractor.
25. The method of claim 1 wherein said portal is created along said central axis of said humeral neck from an anterolateral cortex of said proximal humerus to a center of a humeral head of said implant.
26. The method of claim 25 wherein said creating of said portal is performed by at least one instrument selected from the group consisting of a radiographic guidance system, a guide wire, a specialized transhumeral portal guide, a handled transhumeral portal guide protective sheath, a radiolucent guide extension, and a cannulated drill bit.
27. The method of claim 1 further comprising preparing a proximal surface and a glenoid surface associated with a glenohumeral joint via at least one instrument selected from the group consisting of a transhumeral surgical instruments, protective guards and guides.
28. The method of claim 27 wherein said transhumeral surgical instruments are selected from the group consisting of transhumeral humeral head reamer, transhumeral glenoid reamers, transhumeral drills, a transhumeral burr, a transhumeral glenoid keel punch, a transhumeral irrigation and suction catheter, a transhumeral cementation catheter, a transhumeral keel glenoid cement pressurizer, a transhumeral peg glenoid cement pressurizer, a transhumeral glenoid screwdriver, a transhumeral glenoid impactor, a transhumeral glenoid insertor, and a transhumeral multiple peg glenoid insertor.
29. The method of claim 27 wherein said protective guards and guides are selected from the group consisting of a transhumeral protective sheath, a glenoid sizer and centering hole guide, a glenoid surface protective guard, a humeral head surface protective guard, a keel glenoid drill guide, a peg glenoid drill guide, a transhumeral glenoid drill guide sleeve, a transhumeral glenoid screw guide sleeve, and a multiple peg glenoid insertor guide.
30. The method of claim 28 wherein implanting utilizes at least one of said transhumeral surgical instruments, and insertion of said implant wherein a component of said implant inserted is through said first anterosuperior passage.
31. The method of claim 11 wherein said humeral implant comprises a first component and a removably attached second component.
32. The method of claim 31 wherein said first component comprises a humeral surface and said second component comprises a removably attached stem.
33. The method of claim 32 wherein one of said first and second components is inserted via said anterosuperior passage.
34. The method of claim 33 wherein the other of said first and second components is inserted through said portal via said second anterosuperior passage.
35. The method of claim 32 wherein said first and second humeral implant components are inserted into said shoulder via said first anterosuperior passage.
36. The method of claim 9 wherein said glenoid implant comprises an ingrowth shell and a wear-resistant surface, wherein said ingrowth shell further comprises a hemispherical shell surrounded by an outer flat surface.
37. The method of claim 36 wherein said ingrowth shell further comprises a central cannulation and a peripheral cannulation for accommodating attachment screws, wherein said cannulations may be selected from the group consisting of smooth and threaded.
38. The method of claim 37 wherein said ingrowth shell has a thickness of from about 0.1 to about 10 mm.
39. The method of claim 38 wherein said ingrowth shell has a thickness of from about 0.1 to 2.0 mm.
40. The method of claim 36 wherein said ingrowth shell further comprises an in-growth material or covering an entire surface of a convex side for promotion of bone growth and adhesion to said glenoid.
41. The method of claim 40 wherein said ingrowth material is selected from the group consisting of autologous or allograft osteogenitor cells or tissues, bone morphogenic proteins, hydroxyapaptite coating, trabecular metal, porous metal, porous metal coating, titanium, and tantalum.
42. The method of claim 37 wherein said screws are selected from the group consisting of a compression screw and a fixed angle screw.
43. The method of claim 42 wherein said wear-resistant surface is 0.1 to 15 mm thick above a glenoid bony surface and said flat outer surface of said ingrowth shell.
44. The method of claim 36 wherein said wear-resistant surface is 4 to 7 mm thick above said glenoid bony surface and said flat outer surface of said ingrowth shell.
45. The method of claim 42 wherein said compression screw and said fixed angle screw may be inserted via said anterosuperior passage or via said portal.
46. The method of claim 32 wherein said humeral surface has a spherical shape.
47. The method of claim 32 wherein said humeral surface has a central spherical shape and a peripheral elliptical shape.
48. The method of claim 32 wherein said humeral surface and said removably attached stem are mated together.
49. The method of claim 1 wherein matter or bone removed from said neck of said proximal humerus to create said portal is not reimplanted within said portal.
50. A humeral implant comprising a first component removably attached to a second component.
51. The humeral implant of claim 50 wherein said first component is a humeral surface and said second component is a removably attachable stem.
52. The implant of claim 51 wherein said humeral surface has a coronal radius of curvature and an axial radius of curvature.
53. The implant of claim 52 wherein said coronial radius of curvature has a range of from 10 to 50 mm.
54. The implant of claim 52 wherein said axial radius of curvature has a range of from 10 to 50.
55. The implant of claim 52 wherein said humeral surface has a depth with a range of from 5 to 40.
56. The implant of claim 52 wherein said humeral surface has a thickness with a range of from 0.1 to 10.
57. The implant of claim 52 wherein a ratio of a depth of said humeral surface to said coronal radius of curvature is from about ON to about 0.9.
58. The implant of claim 52 wherein said humeral surface is spherically or elliptically shaped.
59. The implant of claim 52 wherein said humeral surface is made of a material selected from the group consisting of cobalt chrome alloy, ceramic, metal, and magnet materials.
60. The implant of claim 52 wherein said humeral surface further comprises fins or spikes on a concave undersurface of said humeral surface.
61. The implant of claim 52 further comprising a concave undersurface for bony ingrowth material.
62. The implant of claim 52 wherein said humeral surface has a smooth articulating surface.
63. The implant of claim 52 wherein said attachable stem has a diameter with a range of from 0.1 to 5.0 cm.
64. The implant of claim 63 wherein said attachable stem is made of a material selected from the group consisting of titanium, stainless steel, tantalum, porous metal and trabecular metal.
65. The implant of claim 64 wherein said removably attached stem further comprises a smooth, textured or threaded surface.
66. The implant of claim 65 wherein said removably attached stem is round, square, or triangular.
67. The implant of claim 66 wherein said removably attached stem further comprises fins.
68. The implant of claim 66 wherein said removably attached stem further comprises a bony ingrowth surface.
69. The implant of claim 51 wherein said removably attached stem has variable length wherein said stem extends from a lateral cortex of said humerus to a center of a head of said humerus.
70. The implant of claim 51 wherein said humeral surface connects to said removably attached stem.
71. The implant of claim 70 wherein said humeral surface connects to said removably attached stem by a technique selected from the group consisting of morse taper, and a screw.
72. A glenoid implant comprising an ingrowth shell, a wear-resistant surface removably attached to said shell, a central screw and a peripheral screw that extend through said ingrowth shell.
73. The implant of claim 72 wherein said wear-resistant surface comprises a superior-inferior axis and an anterior-posterior axis.
74. The implant of claim 73 wherein said superior-inferior axis of said wear-resistant surface has a range of from 20 to 60 mm.
75. The implant of claim 74 wherein said anterior-posterior axis of said wear-resistant surface defines an upper half and a lower half.
76. The implant of claim 75 wherein said lower half of said anterior- posterior axis of said wear-resistant surface has a range of from 15 to 50 mm.
77. The implant of claim 76 wherein said upper half of said anterior- posterior axis of said wear-resistant surface has a range of 10 to 50 mm.
78. The implant of claim 77 wherein a ratio of said upper half to said lower half of said wear-resistant surface is approximately 0.8 to 1.0.
79. The implant of claim 78 wherein a ratio of said lower half of said anterior-posterior axis to said superior-inferior dimension is approximately 0.7 to 1.0.
80. The implant of claim 79 wherein a ratio of said upper half of said anterior-posterior axis to said superior-inferior axis is approximately 0.6 to 1.0.
81. The implant of claim 84 wherein a superior half of said implant is smaller than an inferior half of said implant.
82. The implant of claim 81 wherein said implant has a central thickness with a range of from about 0.1 to about 50 mm and a peripheral thickness with a range from about 0.1 to 50 mm.
83. The implant of claim 82 wherein said thickness may vary across said superior-inferior axis or across the anterior-posterior axis.
84. The implant of claim 83 wherein said implant has a superior- inferior radius of curvature that is larger than a coronal radius of curvature of a humeral surface of a humerus with which said implant will articulate.
85. The implant of claim 84 wherein said implant has an anterior- posterior radius of curvature that is larger than said axial radius of curvature of said humeral surface with which said implant will articulate.
86. The implant of claim 72 wherein said ingrowth shell comprises a flat surface and a cannulated convex surface.
87. The implant of claim 86 wherein said flat surface mates with a glenoid surface of a scapula and said convex surface mates with a reamed concave surface of a glenoid.
88. The implant of claim 72 wherein said ingrowth shell comprises a material selected from the group consisting of metal, titanium, stainless steel, tantalum, porous metal, trabecular metal, and a ceramic.
89. The implant of claim 72 wherein said ingrowth shell comprises an ingrowth material to promote bone growth and adhesion of said shell to a glenoid surface.
90. The implant of claim 72 wherein said wear-resistant surface is 0.1 to 15 mm thick.
91. The implant of claim 90 wherein said wear-resistant surface is 4 to 7 mm thick.
92. The implant of claim 91 wherein said wear-resistant is selected from the group consisting of plastic, polyethylene, ceramic, metal, and magnetic material.
93. The implant of claim 92 wherein said wear-resistant surface mates with said ingrowth shell.
94. A transhumeral portal guide comprising a bullet shaped guide with a central cannulation and a peripheral longitudinal cannulation.
95. The guide of claim 94 further comprising a transhumeral portal guide protective sheath with a handle, wherein said transhumeral portal guide interfits with a transhumeral portal guide protective sheath.
96. The guide of claim 95 wherein said handle has a radiolucent guide extension connected thereto.
97. The guide of claim 96 wherein said guide extension comprises a radiolucent arm connected to a spherical guiding end.
98. The guide of claim 97 wherein said arm is connected to said handle of said transhumeral portal humeral guide protective sheath.
99. The guide of claim 98 wherein said guide extension comprises a radioopaque linear marker within said arm.
100. A transhumeral humeral reamer comprising a working head and a removably attached shaft, wherein said shaft has a diameter ranging from 0.1 to 5.0 cm.
101. A transhumeral glenoid reamer comprising a reaming surface and a removably attached shaft, wherein said shaft has a diameter ranging from 0.1 to 5.0 cm.
102. The reamer of claim 101 wherein said reaming surface and said shaft are cannulated.
103. A shoulder structure comprising a humerus portal tube wherein said tube has a diameter ranging from 0.1 to 5.0 cm.
104. The structure of claim 103 wherein said sheath is comprised of a metal or a wear-resistant material.
105. The structure of claim 104 wherein said sheath is press-fit or screwed into a transhumeral portal.
106. The structure of claim 105 wherein said sheath has a wall thickness of about 0.1 to 10 mm.
107. The structure of claim 106 wherein said sheath has a wall thickness of from about 0.1 to 3 mm.
108. The structure of claim 107 wherein said sheath has a wall thickness of from 0.1 to about 1 mm.
109. A glenoid surface protective guard comprising a protective surface and a handle wherein said protective surface is shaped similarly to a glenoid surface.
110. The protective guard of claim 109 wherein said protective surface is metal.
111. The protective guard of claim 110 wherein said protective surface has an elevated peripheral edge.
112. The protective guard of claim 111 wherein said protective surface has a thickness with a range of from 0.1 to 2.0 mm.
113. A humeral head surface protective guard comprising a protective surface.
114. The protective guard of claim 113 further comprising a handle.
115. The protective guard of claim 113 wherein said protective surface comprises an ingrowth shell that is centrally cannulated.
116. The protective guard of claim 115 wherein said protective surface has a thickness with a range of from 0.1 to 2.0 mm.
117. A glenoid sizer comprising a glenoid contacting surface and a removably attached handle.
118. The sizer of claim 117 wherein said glenoid contacting surface further comprises a central hole.
119. The sizer of claim 11 δwherein said glenoid contacting surface has a thickness with a range of from 0.1 to 5 mm.
120. The drill guide of claim 119 wherein said guiding surface further comprises additional holes, wherein said additional holes are either a) inferior and superior toward a center of said guiding surface, or b) said additional holes are in the periphery of said guiding surface.
121. The drill guide of claim 120 wherein said drill guide interfits with a drill.
122. The drill guide of claim 120 wherein said guiding surface has a thickness with a range of 0.1 to 5 mm.
123. The drill guide of claim 122 further comprising a sleeve wherein said sleeve has a diameter with a range of from 0.1 to 5 mm and said drill guide interfits within said sleeve.
124. A transhumeral glenoid drill comprising a working surface and a removably attached shaft wherein said shaft has a diameter with a range of from 0.1 to 5 mm.
125. The drill of claim 124 wherein said working surface comprises a drill bit.
126. The drill of claim 124 wherein said shaft further comprises markings that define a measurement of depth or distance.
127. A transhumeral burr comprising a high speed working burr surface and a removably attached shaft wherein said shaft has a diameter with a range of from 0.1 to 5 cm.
128. A glenoid keel punch comprising a working head and a removably attached shaft, wherein said working head further comprises a keel shape with cutting teeth, wherein said shaft has a diameter with a range of from 0.1 to 5 cm.
129. A transhumeral irrigation and suction catheter comprising a semirigid plastic tubing that is removably attached to a fluid pump and a suction device, wherein said tubing has a diameter with a range of from 0.1 to 5 cm.
130. A transhumeral cementation device comprising a removably attached shaft, a head, and tubing, wherein said shaft has a diameter ranging from 0.1 to 5.0 cm.
131. The device of claim 130 wherein said head further comprises a cannulated tip from which cementation material may be delivered to a surface or hole.
132. The device of claim 131 wherein which said tip prevents said cementation material from escaping from said hole.
133. A transhumeral glenoid impactor comprising a dome-shaped head and a removably attached shaft, wherein said shaft has a diameter ranging from 0.1 to 5 cm.
134. The impactor of claim 133 wherein said head further comprises a convex surface.
135. The impactor of claim 134 wherein said head is plastic.
136. The impactor of claim 133 wherein said shaft has a diameter with range of from 0.1 to 5 cm.
137. A transhumeral screw driver comprising a working head and a removably attached shaft wherein said shaft has a diameter ranging from 0.1 to 5 cm.
138. The screwdriver of claim 137 wherein said working head is hexagonally shaped.
139. The screwdriver of claim 138 further comprising a transhumeral screw guide sleeve, wherein said sleeve comprises a passage in which said transhumeral screwdriver interfits.
140. The screwdriver of claim 139 wherein said sleeve has a diameter with a range of from 0.1 to 5 cm.
141. The screwdriver of claim 140 wherein said sleeve interfits within a transhumeral protective sheath, wherein said transhumeral protective sheath comprises a tube of material, wherein said tube has a diameter ranging from 0.1 to 5.0 cm.
142. The screwdriver of claim 141 wherein said sleeve interfits with a transhumeral glenoid drill guide sleeve, wherein said transhumeral glenoid drill guide sleeve has a diameter with a range of from 0.1 to 5 mm and wherein a drill guide interfits within said sleeve.
143. A rotator interval retractor comprising a first blade dimensioned for interaction with a supraspinatus and a second blade dimensioned for interaction with a subscapularis.
144. A glenohumeral joint comprising a transhumeral portal along a central axis of a neck of a proximal humerus and an implant.
145. The glenohumeral joint of claim 144 wherein said implant is a humeral implant.
146. The glenohumeral joint of claim 144 wherein said implant is a glenoid implant.
147. A repaired humerus bone comprising a modular implant with a humeral suface and a stem, wherein said stem is anchored in the epiphyseal-metaphyseal portion of said humerus bone.
148. The repaired humerus bone of claim 147 wherein said stem has a diameter with a range of from 0.1 to 5.0 cm.
149. The repaired humerus bone of claim 148 wherein said stem has is linear.
150. A humeral implant comprising a humeral surface component and no stem.
151. A repaired glenoid of a scapula comprising a modular implant, and a recess within a glenoid.
152. The repaired glenoid of claim 151 wherein said modular implant comprises an ingrowth shell and a wear-resistant surface.
153. The repaired glenoid of claim 152 wherein said ingrowth shell interfits within said recess of said glenoid.
154. The repaired glenoid of claim 153 wherein said wear-resistant surface interfits within a concavity of said ingrowth shell.
155. A method of arthroscopic rotator cuff repair comprising the steps of a) inserting an insertional guide into a humerus; b) extending a bore of said insertional guide into a humerus; c) inserting a suture pin through a greater tuberosity of said humerus into an anteromedial suprapsinatus rotator cuff footprint; d) advancing said suture pin out of said rotator cuff and through a superior soft tissue and skin; e) removing said pin; f) tying said suture.
156. A suture pin comprising a tip, a pin shaft, and suture, wherein said tip has a diameter that is larger than said pin shaft, and said pin shaft.
157. The suture pin of claim 156 wherein said tip is a trocar tip.
158. An insertional guide comprising a handle, and a cannulated tip, wherein said cannulated tip further comprises a sharp tip.
159. The insertional guide of claim 158 further comprising a protective sheeth comprising a handle and a shaft with a blunt end.
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US60/511,805 2003-10-16
US52340103P 2003-11-19 2003-11-19
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US57989304P 2004-06-15 2004-06-15
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US9968459B2 (en) 2018-05-15
US20070005074A1 (en) 2007-01-04
US20050043805A1 (en) 2005-02-24
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US9445910B2 (en) 2016-09-20
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US20070027477A1 (en) 2007-02-01
US8540737B2 (en) 2013-09-24

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