This application is a divisional of application Ser. No. 11/482,038, filed Jul. 7, 2006, now U.S. Pat. No. 8,512,376, which claims the benefit of U.S. Provisional Application Ser. No. 60/697,125 filed on Jul. 7, 2005, and which is a continuation-in-part of application Ser. No. 10/233,122, filed Aug. 30, 2002, now U.S. Pat. No. 7,235,091, which claims priority under 35 U.S.C. §119 to IE S2002/0504, filed Jun. 20, 2002. The entire disclosures of all priority application listed above are incorporated herein by reference.
FIELD OF THE INVENTIONThe present invention relates to an apparatus for internal fixation of an acromioclavicular joint dislocation of the shoulder with resultant superior migration of the lateral end of the clavicle with respect to the acromium and the coracoid of the scapula.
BACKGROUND OF THE INVENTIONAcromioclavicular (“AC”) joint dislocations are characterized by severe upward displacement of the lateral end of the clavicle relative to the acromium of the scapula. Surgery is recommended to reduce and internally fix the displacement, which could otherwise lead to a painful deformity and loss of function.
This invention relates to reconstruction surgery and particularly to reconstruction surgery for Rockwood types II-VI AC joint dislocations of the shoulder (Rockwood, Williams, & Young,Injuries to the Acromioclavicular Joints, in FRACTURES INADULTS1341-1413 (Rockwood & Green, eds., 3rded., 1996)). More particularly, the invention relates to the use of a first suture anchor-suture-second suture anchor technique to reduce and internally fix the dislocation between the clavicle and the coracoid process.
Injuries to the AC joint are generally classified as types I-VI, depending on the type and amount of disruption to the AC and the coracoclavicular ligaments. A type III AC dislocation of the shoulder is a common injury that occurs primarily from having a fall to the point of the shoulder. A type III injury is characterized by disruption of the AC and coracoclavicular ligaments, the dislocation of the AC joint and the upward relative displacement of the lateral end of the clavicle. The coracoclavicular interspace is greater than in the normal shoulder.
There are presently two basic treatment options available: non-operative treatments and operative procedures.
The non-operative option includes external, closed reduction. Various external, closed reduction procedures have been tried in the past using straps, casts, and different taping techniques. Generally, it has been believed that the procedures would work if applied continuously. Unfortunately, it has been found not to work as no one can wear them continuously because of skin breakdown and discomfort. As a result, such treatment regimes rarely have been successful. The patient must inevitably accept a cosmetic deformity and suffer from pain and fatigue after prolonged physical activity or heavy lifting.
Operative treatments to date have focused on open reduction and direct repair or reconstruction of the ligaments. This procedure corrects the deformity and is generally accepted as providing the best results. However, this usually entails an extensive open operation. The deltoid and trapezius muscles are taken off the clavicle and dissected to expose the underside of the clavicle and the coracoclavicular ligaments and the coracoid process. The procedure requires an in-hospital stay, extended time for the surgical wound to heal, and rehabilitation. The open reduction procedure is generally recommended as the treatment of choice for people involved in heavy lifting work or active athletics. The remaining population is generally told to accept the deformity and to accept the pain and fatigue after heavy lifting or activity.
It is well-known in the art to fix the coracoclavicular space by drilling a hole through the clavicle and into the coracoid process and by then inserting a screw (a Bosworth screw, for example) therebetween. It is also well-known to loop a flexible coupling such as a nylon tape around both the coracoid and the clavicle and to knot them together. This has the disadvantage of requiring that all of the coracoid be exposed. It is also known to drill a hole in the coracoid process and attach a single suture anchor, with a pair of sutures extending therefrom, into the coracoid. The free ends of the sutures are then looped about the clavicle and tied to each other.
Non-operative treatment options generally provide unacceptable results. The open reduction treatment, while providing generally good results, has the disadvantage of an in-hospital stay plus the extensive time required for healing and rehabilitation. A surgical outpatient technique that would correct the deformity and allow healing of the injury in a normal anatomic position without extensive tissue dissection and less scarring would provide a substantial improvement over current treatment methods.
It is an object of the present invention to overcome the problems associated with the prior art, whilst permitting normal physiological movement of the clavicle relative to the coracoid.
BRIEF SUMMARY OF THE INVENTIONThe present invention relates to a surprising use of a first suture anchor-suture-second suture anchor technique. The method of the present invention is simple and is performed by a mini-open approach.
In a first aspect of the present invention there is provided an apparatus for use in internal fixation of AC joint dislocations of a shoulder. The apparatus of the first aspect of the present invention is a kit of parts for internal fixation of an AC joint dislocation of a shoulder, the shoulder including a clavicle, a coracoid process and an acromium, the kit of parts comprising a first suture anchor; a second suture anchor, the first and second suture anchors being adapted for engagement in or on the clavicle and the coracoid process, respectively; a flexible coupling mountable, in use, between the first and second suture anchors; and a needle releasably securable to at least one of the first and second suture anchors, in which the first and second suture anchors each have at least first and second apertures and the flexible coupling is a first suture which is double looped through the first and second suture anchors.
Preferably, the first suture is fed, in use, through a first aperture of the second suture anchor, and through, in turn, the second and first apertures of the first suture anchor and through, in turn, second and first apertures of the second suture anchor, and through, in turn, the second and first apertures of the first suture anchor and through the second aperture of the second suture anchor.
Preferably, the first suture anchor comprises a button and the second suture anchor comprises a washer, the washer being adapted and dimensioned to engage with a bone anchor. Alternatively, each of the first and second suture anchors can be a button. In another embodiment, each of the first and second suture anchors can be a washer, the washer being adapted and dimensioned to engage with a bone anchor. In yet another embodiment, the first suture anchor is a washer and the second suture anchor is a button. The bone anchor may be a bone screw, a bone nail, a bone staple or an intraosseous bone anchor. A bone screw is preferred. Even more preferably, the washer has a central aperture and at least two, preferably at least four, peripheral apertures, the central aperture being adapted and dimensioned to accept a bone screw.
More preferably, the first suture anchor is a button having an oblong body and first and second apertures and the second suture anchor is a washer adapted to engage with a bone anchor and having at least two, preferably at least four, peripheral apertures. In this embodiment, the first suture is fed through a first peripheral aperture of the washer and through, in turn, the second and first apertures of the button and through, in turn, second and third peripheral apertures of the washer, and through, in turn, the second and first apertures of the button and through the fourth peripheral aperture of the washer. A loop is formed on the underneath of the washer, by the path of the first suture between the second and third peripheral apertures. If desired, the free ends of the first suture may be fed under this loop, to provide a self-tightening suture.
When one or both of the suture anchors is a button, the needle is preferably secured to one or both of the first and second buttons by means of a second suture looped through one of the first or second apertures of the first and/or second buttons, the second suture being operatively associated with the needle.
In a second aspect of the present invention there is provided a method for internal fixation of AC joint dislocations. The method of the present invention comprises the steps of providing an apparatus according to the first aspect of the present invention; securing the first and second suture anchors on or adjacent the clavicle and the coracoid process, respectively; and reducing and fixing the distance between the clavicle and the coracoid process, by traction of the flexible coupling.
When the apparatus of the first aspect of the invention comprises a button as the first suture anchor and a washer as the second suture anchor, the method preferably comprises the steps of drilling a clavicle hole through the clavicle and a coracoid hole into the coracoid process; passing the needle through the clavicle hole, so as to advance the button longitudinally through the clavicle hole; pivoting the button so as to engage the button against a superior surface of the clavicle; inserting a screw through a central aperture of the washer into the coracoid hole in a superior aspect of the coracoid process; and reducing and fixing the distance between the clavicle and the coracoid process, by traction of the flexible coupling. Preferably, the needle is uncoupled from the button when the button has been advanced through the clavicle hole and has engaged against the superior surface of the clavicle.
It will be appreciated by those skilled in the art that traction of the flexible coupling can be effected by hand traction or by the use of a suture tensioner. Suitable suture tensioners are well known in the art.
In a third aspect of the present invention there is provided a button for use in the apparatus of the first aspect of the invention and for use in the method of the second aspect of the present invention. The button of the third aspect of the invention can be used as either the first or second suture anchor or as each of the first and second suture anchors. The button of the third aspect of the present invention may comprise an oblong body defining first and second apertures. Preferably, each of the first and second apertures is oblong, their longitudinal mid-lines being located substantially about a longitudinal mid-line of the oblong body.
Alternatively, each of the first and second apertures is substantially triangular in plan view. In this alternative embodiment, each aperture is tapered and terminates in an apex, the apices being directed away from each other. Preferably, each of the apertures comprises first, second and third walls and the first walls of the respective first and second apertures are substantially parallel.
The button of the third aspect of the present invention may have any suitable dimension (width, length and thickness). If the button is oblong, for example, the button of the third aspect of the present invention can have a width of 2.5 mm to 4.0 mm without compromising implant strength, although a width of 3.0 mm to 4.0 mm is preferred. The length of the button of the third aspect of the present invention is less critical but may, for example, be in the range 7.5 mm to 12.5 mm. A length in the range 9 mm to 11 mm is preferred since the button of the third aspect of the present invention is then slightly less palpable under the skin following implantation.
Each of the first and second apertures of the button of the third aspect of the present invention may have any shape or geometry. For example, one embodiment is an aperture which is substantially triangular in plan view. Another embodiment is an egg-shaped or oval aperture, the curved narrower end comprising the apex.
In a fourth aspect of the present invention there is provided a washer for use in the apparatus of the first aspect of the invention and for use in the method of the second aspect of the present invention. The washer of the fourth aspect of the invention can be used as either the first or second suture anchor or as each of the first and second suture anchors. The washer of the fourth aspect of the present invention comprises a body adapted for engagement with a bone anchor and having at least two, preferably at least four, peripheral apertures. The washer of the fourth aspect of the present invention optionally comprises a disc-shaped body defining a central aperture shaped and dimensioned to accept a bone screw and having four peripheral apertures. Preferably, each of the central and peripheral apertures is circular in plan view.
The washer of the fourth aspect of the present invention can have an external diameter of 6.5 mm to 13.0 mm and a thickness of 1.0 mm to 2.0 mm without compromising implant strength, although an external diameter of 8 mm to 12 mm and a thickness of about 1.5 mm is preferred. The central aperture of the washer of the fourth aspect of the present invention can have an internal diameter of 2.5 mm to 6.5 mm, although an internal diameter of 3.5 mm to 5.5 mm is preferred. In an optional embodiment, the four peripheral apertures of the washer of the fourth aspect of the present invention can have an internal diameter of 0.5 mm to 2.0 mm, although an internal diameter of 0.8 mm to 1.2 mm is preferred.
As used herein, the term “button” or “washer” is intended to mean any suitably shaped and dimensioned suture anchor or stress bearing member which is capable of transmitting a force incident thereon to any body with which the button or washer is in contact.
BRIEF DESCRIPTION OF THE DRAWINGSThese and other features and advantages of the invention will be more apparent from the following detailed description that is provided in connection with the accompanying drawings and illustrated exemplary embodiments of the invention, in which:
FIGS. 1 and 1ashow an anterior view and a schematic view, respectively, of a normal acromioclavicular joint;
FIGS. 2 and 2ashow an anterior view and a schematic view, respectively, of a Rockwood Type III acromioclavicular joint dislocation, with superior migration of the clavicle with respect to the acromium;
FIG. 3 shows a plan view of a first or second suture anchor in the form of a button of the present invention;
FIG. 4 shows perspective, plan and sectional view of an alternative embodiment of a button according to the invention;
FIGS. 5 and 5ashow a plan and an undersurface view, respectively, of a first or second suture anchor in the form of a washer of the present invention;
FIG. 5billustrates the mobile positioning of the washer against an arcuate undersurface of the screw-head of a bone anchor;
FIG. 6 shows a perspective view of the kit of parts comprising an apparatus of the present invention; and
FIGS. 7a-7fillustrate, in sequence, the steps of a method according to the present invention.
DETAILED DESCRIPTION OF THE INVENTIONIn the following detailed description, reference is made to the accompanying drawings, which form a part hereof and illustrate specific embodiments in which the invention may be practiced. In the drawings, like reference numerals describe substantially similar components throughout the several views. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that other embodiments may be utilized, and that structural, logical and electrical changes may be made without departing from the spirit and scope of the present invention.
The present invention provides minimally invasive, flexible fixation of the AC joint dislocation by resisting superior migration of the clavicle with respect to the coracoid process. It allows physiological micromotion at the AC joint. There should be no need for routine removal of the implant.
The present invention is indicated for use in the fixation of AC joint dislocation. These are typically seen in Rockwood type III AC joint dislocations, usually caused by severe downward blunt trauma to the point of the shoulder, or acromium. Typically, the clavicle is upwardly displaced as a result of the injury because of disruption to the AC and coracoclavicular ligaments. Reduction and fixation of displaced AC joint dislocations are necessary to prevent painful deformity and loss of function.
FIGS. 1 and 1ashow anterior and schematic views of anormal shoulder10.FIGS. 2 and 2ashow anterior and schematic views of ashoulder10 that has suffered a Rockwood type III AC joint dislocation injury.
Referring toFIGS. 1 and 2, the structure of ashoulder10 relevant to a Rockwood type III dislocation injury includes theclavicle12, thecoracoid process14 and theacromium16. Theacromium16 and theclavicle12 are connected by theacromioclavicular ligament18. Theacromioclavicular ligament18 extends from thelateral end20 of theclavicle12 to themedial surface22 of theacromium16. Thecoracoid process14 is connected to theclavicle12 by thecoracoclavicular ligaments24, which comprise thetrapezoid ligament26 and theconoid ligament28. Thecoracoclavicular ligaments24 extend from theinferior surface30 of theclavicle12 to thesuperior surface32 of thecoracoid process14.
A Rockwood type III AC joint dislocation is characterized by the disruption of the AC and thecoracoclavicular ligaments18,24, respectively. As shown inFIGS. 2 and 2a,theclavicle12 separates from, and moves away from, thecoracoid process14 and theacromium16, accompanied by disruption of the coracoclavicular and theAC ligaments18,24, respectively. The acromioclavicular joint34 (FIG. 2) is dislocated and theclavicle12 is relatively displaced upwardly. The coraco-acromial ligament36 (FIG. 1) is not impacted in the type III shoulder dislocation.
Repair of the type III shoulder dislocation according to the present invention is an out-patient procedure performed with a general anesthetic. The procedure is done with the patient lying supine on the operating table, preferably in the “deck-chair” position to allow the surgeon full access to the affected shoulder.
Referring toFIG. 3, the apparatus of the present invention comprises a first or second suture anchor in the form of abutton50, which, in the embodiment illustrated, is about 10.0 mm in length by about 3.5 mm in width. Thebutton50 is preferably formed from titanium or stainless steel, although it will be appreciated that any other suitable material could be used, in particular any suitable bioabsorbable material. Thebutton50 has afirst aperture52 and asecond aperture54 which, in the embodiment illustrated, are oblong in shape, the longitudinal mid-line of each of the first andsecond apertures52,54 being located substantially about a longitudinal mid-line of thebutton50.
Referring toFIG. 4, there is illustrated an alternative first or second suture anchor, generally indicated as150. In the illustrated alternative embodiment, thebutton150 is about 9.0 mm in length by about 3.5 mm in width, with a thickness of about 1.5 mm. Thebutton150 has first andsecond apertures152 and154, respectively. In the illustrated alternative embodiment, each of theapertures152,154 are triangular in shape, therespective apices155 being directed away from each other and being located substantially about a longitudinal mid-line of thebutton150.
Reference is now made toFIGS. 5 and 5awhich illustrate a first or second suture anchor in the form of awasher60. In the illustrated embodiment, thewasher60 has an external diameter of about 10.0 mm. While the illustrated washer is disc-shaped, the washer is not so limited. Thewasher60 is preferably formed from titanium or stainless steel although, as will be appreciated by those skilled in the art, any other suitable material, in particular any suitable bioabsorbable materials, may be used. Thewasher62 also has at least two flexible coupling-locatingapertures64. In the illustrated embodiment, there are fourapertures64 circumferentially arranged about theaperture62. In the illustrated embodiment, each of theapertures64 has a diameter of about 1.0 mm. Each of theapertures64 have beveled edges, above and below, while theaperture62 has beveled edges above.
Thewasher60 also has a substantially centrally located bone screw-retainingaperture62. In the illustrated embodiment, theaperture62 has a diameter of about 4.6 mm and thewasher60 is adapted to allow mobile positioning against anarcuate undersurface69 of the head of the bone screw68 (illustrated inFIG. 5b).
Referring toFIGS. 5 and 5a,thewasher60 of the fourth aspect of the present invention is provided with a screw-retainingaperture62 and at least two flexible coupling-locatingapertures64 which are preferably countersunk so as to allow easier threading passage of the flexible coupling70 (not shown inFIGS. 5-5b). Care needs to be taken in such countersinking, to avoid compromising the mechanical strength of theapertures62,64 of thewasher60.
FIG. 6 illustrates the implant apparatus used for fixation of the AC joint dislocation. Thebutton50 and thewasher60 are secured or pre-threaded together by means of a flexible coupling in the form offirst suture70, preferably of number 5-strength braided polyester, which is double looped through the first andsecond apertures52,54 of thebutton50 and theperipheral apertures64 of thewasher60, as will now be described in greater detail. Specifically, thefirst suture70 is fed through toaperture64aof thewasher60; through the second andfirst apertures54,52 of thebutton50; through theaperture64b,under thewasher60 and back out the aperture64c;through the second andfirst apertures54,52 of thebutton50 again; and finally through theaperture64dof thewasher60. Aneedle72, which may be straight or curved, with a second, pull-throughsuture74 is also looped through either the first orsecond apertures52,54 of thebutton50. Thesecond suture74 is looped through thefirst aperture52 of thebutton50.
Thefirst suture70 used in the apparatus can be made from any material which is suitable for this purpose, whether absorbable or non-absorbable, provided it is sufficiently strong. A number 5-strength braided polyester (FIBERWIRE®) suture is preferred. This is a non-absorbable suture which knots easily without slipping. Thesecond suture74 can be made from any material which is suitable for this purpose, and preferably should be at least 0-strength.
The pull throughneedle72 can be of any dimensions, provided it is long enough to span theclavicle12 or thecoracoid process14 of theshoulder10. Theneedle72 is preferably about 100 mm in length. The needle's body can either be straight or curved. The needle's tip can be either “taper cut” or “cutting.”
In the present embodiment, leading and trailing edges of thebutton50 are substantially symmetrical, although it will be appreciated that this is not a requirement of the present invention. Specifically, the leading edge56 (illustrated inFIG. 6) of thebutton50 should be blunt and should have a width sufficient to reduce the possibility that the leadingedge56 of thebutton50 follows the second or pull-throughsuture74 through the intact skin or to catch or skewer any soft tissue structures between the bone and the skin, as will be described in detail hereinafter.
FIG. 6 also illustrates abone screw68 as part of the implant apparatus. Thebone screw68 is used for engaging thewasher60 with the coracoid process14 (FIG. 7f). As discussed below in detail and with reference toFIG. 5b,thebone screw68 has anarcuate undersurface69 for defining the movement of thewasher60 between thecoracoid process14 and thearcuate undersurface69.
| TABLE 1 |
|
| Apparatus/Button of FIGS. 3 and 6 |
|
|
| Button 50 overall | 10.0 mm (length) × 3.5 mm (width) × 1.5 mm |
| dimensions: | (thickness) |
| Basic shape: | Oblong in plan shape, with chamfered or |
| rounded corners and edges - this reduces the |
| chance of thebutton 50 being palpated under the |
| skin and, in addition, eases the passage of the |
| button 50 through a drill hole as will be |
| explained hereinafter. |
| Button 50 material: | Preferably titanium or stainless steel |
| Button apertures | Twoapertures 52, 54 (oblong in plan shape) |
| 52, 54: |
| Apertures 52, 54 | 2 mm height × 3 mm length (oblong with |
| dimensions: | chamfered edges), preferably 1 mm distance |
| between first andsecond apertures |
| Suture |
| 70 | Number 5-strength braided polyester suture, |
| (first suture): | looped twice through the first andsecond |
| apertures |
|
| 52, 54 of thebutton 50 and each of the |
| four peripheral apertures 64 (64a, 64b, 64c, 64d) |
| of thewasher 60, leaving the two free ends of |
| suture 70 free for tying adjacent the undersurface |
| of thewasher 60. |
| Pull-through needle | 100 mm long straight, or curved,needle 72 with |
| 72: | pull-through, orsecond suture 74 attached. |
| Pull-through suture 74: | Minimum 0-strength suture 74 looped through |
| theaperture 52 of thebutton 50,second suture 74 |
| being secured toneedle 72. |
|
The following sets out the procedure, as shown inFIGS. 7a-7f,to be followed for Rockwood Type III dislocations. Surgeons skilled in the art will appreciate the modifications that might be needed in addressing Rockwood Type II and IV-VI dislocations.
Set-upThe patient is positioned in a “deck-chair” position on the operating table (not shown). A sandbag (not shown) can be placed under the scapula to ease access to the shoulder region. A longitudinal or horizontal incision of about 5 cm is made on the skin, at the front of the shoulder, overlying thecoracoid process14 and theclavicle12. Theclavicle12 and the superior surface of thecoracoid process14 are exposed by blunt dissection. As explained in detail below, if theclavicle hole80 is to be drilled (FIG. 7a) from above and substantially downwardly through theclavicle12, it will also be necessary to retract the skin about theclavicle12, in order to expose thesuperior surface33 of theclavicle12.
InstrumentationA 3.5 mm drill bit is required for drilling ahole80 through theclavicle12. A 2.5 mm drill bit is required for drilling ahole82 into the base of thecoracoid process14 of the scapula (FIG. 7a). It is not necessary that the drill holes80,82 be aligned with each other. In addition, it is not necessary, when the coracoclavicular interspace is reduced to normal, that the longitudinal axes of the respective drill holes80,82 be co-linear or even substantially parallel with each other.
Button PlacementAs illustrated inFIG. 7b,the longstraight needle72 with pull-through,second suture74 is passed upwards through the 3.5mm drill hole80 in theclavicle12 and can be passed through the intact skin on the superior aspect of theclavicle12 or through the open surgical wound. InFIG. 7c,the pull-throughsuture74, which engages the first aperture52 (not shown) of thebutton50, can now advance thebutton50, substantially longitudinally through thedrill hole80. Engagement of thesecond suture74 in the aperture52 (not shown) ensures that thesecond suture74 is located adjacent the longitudinal mid-line of thebutton50 so that thesecond suture74 stays central in thefirst aperture52.
InFIG. 7d,once thebutton50 has exited thesuperior surface33 of theclavicle12, the angle of traction on the pull-through, or second,suture74 is changed and counter-traction is exerted on thefirst suture70, in order to flip (pivot) thebutton50 and engage thebutton50 against thesuperior surface33 of theclavicle12. Once thebutton50 is anchored, the pull-through, or second,suture74 can be cut and removed (FIGS. 7dand7e). InFIG. 7f,thescrew68 containing thewasher60 is inserted into the 2.5 mm drill hole82 (FIG. 7e) in the base of thecoracoid process14 of the scapula. Before thewasher60/bone screw68 is fully seated into thedrill hole82, the acromioclavicular joint34 is reduced by downward manual pressure on thelateral end20 of the clavicle12 (FIGS. 7eand7f).
The two trailing ends of the first suture70 (FIG. 7e) are pulled to approximate the desired distance between thebutton50 and thewasher60, and hence reduce the interval between theclavicle12 and thecoracoid process14. Thefirst suture70 is then secured to itself with a knot, tied tight by hand. The free ends of thefirst suture70 can then be cut approximately lcm long, to avoid knot slippage. Thescrew68 can then be fully seated into thedrill hole82 in thecoracoid process14 to maximize suture tension, or may be advanced or retracted accordingly to fine tune the suture tension, according to the surgeon's preference.
The volume between thearcuate undersurface69 of thebone screw68 and thecoracoid process14 defines the maximum flexibility of thewasher60 therebetween. The designed flexibility is helpful in increasing the tolerance for non-aligned drill holes and the like.
Post-operative ManagementFollowing wound closure, the shoulder should be placed in a shoulder immobilizer for three weeks. Gentle range of motion exercises can begin after three weeks. Full range exercises can be allowed after six weeks.
Implant RemovalRoutine removal of the first suture anchor-suture-second suture anchor construct is not required. If, for any reason, it needs to be removed, this can be performed simply by re-opening the surgical incision, cutting thefirst suture70 as it loops through thebutton50 and removing thebutton50. Thescrew68 andwasher60 can be removed easily using the screwdriver.
It is noted that the above description and drawings are exemplary and illustrate preferred embodiments that achieve the objects, features and advantages of the present invention. It is not intended that the present invention be limited to the illustrated embodiments. Any modification of the present invention which comes within the spirit and scope of the following claims should be considered part of the present invention.