Abstract:
Disclosed is a locking spring screw formed from a cylindrical screw body having a screw head that includes a tool slot adapted for receipt of a flexible spring member. The tool slot includes at least one outlet formed adjacent to the tool slot which is adapted for passage therethrough of a tongue extending outwardly from the spring member. A ridge is located opposite the outlet from the cylindrical screw body and formed at least partially around the circumference of the screw head wherein the spring member is retracted during installation and, upon the ridge engaging a flange, the spring member is released preventing screw head removal by entrapping the flange between the ridge and the tongue of the spring member.

Description:
RELATED APPLICATIONS 
     This application is related to an application entitled “Spinal Implant Apparatuses and Methods of Implanting and Using Same”, filed on the same date of Dec. 17, 2010 in the United States Patent and Trademark Office, with the same named inventors, the disclosure of which is incorporated herein by reference. 
     BACKGROUND OF THE INVENTION 
     Implants are widely used to replace a missing biological structure, support a damaged biological structure, or enhance an existing biological structure. Medical implants are man-made devices, in contrast to a transplant, which is a transplanted biomedical tissue. The surface of implants that contact the body might be made of a biocompatible material such as titanium or silicone depending on what is the most functional. In the case of orthopedic implants, like spinal implants, the manner in which the implant is attached to the patient is an important consideration. 
     In many situations, screws are used to secure the implant to hard tissue (e.g. bone) of the patient. One consideration in using screws during orthopedic implantation procedures is ensuring proper screw orientation with respect to the implant when the screw is advanced into the bone. Another consideration is easing the implantation process for an attending medical professional, for example a surgeon installing the implant. 
     SUMMARY OF THE INVENTION 
     An aspect of an embodiment of the invention relates to providing a locking spring screw with a spring member which locks the screw into place with respect to an implantable device while still being able to rotate for attaching the implantable device to an implantation site. In an embodiment of the invention, the implantable device is provided with at least one screw hole, a portion of which is adapted to act as a counterpart to components of the spring screw in order to lock the screw into place with respect to the implantable device. For example, in an embodiment of the invention a portion of the screw hole is adapted to provide a flange which acts as a counterpart to a flange slot created by components of the screw, wherein the flange fits within the flange slot, locking the spring screw substantially within a plane but still allowing rotation of the screw about its vertical axis. In an embodiment of the invention, a spring member is used as at least one of the components for creating the flange slot in which the flange fits. In an embodiment of the invention, a ridge on the head of the screw forms a side of the flange slot opposite the spring member. 
     In an embodiment of the invention, the spring screw and the implantable device are jointly adapted to provide the screw with substantial movement in only one degree of freedom once locked into the implantable device. Optionally, the one degree of freedom is around the vertical axis of the screw. 
     In an embodiment of the invention, the spring member is inserted into a tool slot provided to the head of the spring screw in a flexed state and upon insertion into the tool slot, the spring member assumes an expanded state. Optionally, the spring member is placed into the head of the spring screw during manufacture. Optionally, the spring member is provided with at least one tongue which protrudes through an outlet located on the screw head thereby securing the spring member to the screw head. 
     In an embodiment of the invention, the outlet is located on the screw head above the floor of the tool slot such that the spring member can be flexed towards the floor by a tool. In an embodiment of the invention, the distance the spring member can flex towards the floor and the length of the at least one tongue are correlated to allow for the spring screw to be inserted into the screw hole (while the spring member is flexed) but not to allow the spring member to slip out of the outlet towards the vertical axis of the screw. 
     In an embodiment of the invention, the tool slot also doubles as the interface between the screw and the tool used by the attending medical professional to tighten or loosen the screw with respect to the implantation site. In some embodiments of the invention, the tool slot shape and/or size is varied to accommodate different tools. In some embodiments of the invention, the spring member shape and/or size is varied to accommodate different sized tool slots. 
     In an embodiment of the invention, the cylindrical body of the spring screw is adapted to be driven into an implantation site. For example, the body is provided with threading. In some embodiments of the invention, the implantation site is comprised of hard body tissue, such as bone. Optionally, the spring member remains flexed while the tool is used to drive the screw into the implantation site. 
     A further aspect of an embodiment of the invention relates to a method of using a screw provided with a spring member to secure an implantable device to an implantation site. In an embodiment of the invention, the method uses a screw adapted to lock the screw into place with respect to an implantable device while still allowing the screw to rotate for attaching the implantable device to the implantation site. In an embodiment of the invention, the screw is inserted in a screw hole located on the implantable device while the spring member is flexed towards the floor of a tool slot in the screw head using a tool. In an embodiment of the invention, the screw is advanced fully until a ridge of the head of the screw abuts a flange of the screw hole. The spring member is released by the tool which results in expansion of the spring member such that a tongue portion of the spring member extends out of an outlet in the screw head, trapping the flange of the screw hole in a flange slot formed in between the tongue portion of the spring member and the ridge of the screw head. 
     In an embodiment of the invention, the spring screw is substantially prohibited from moving linearly along its vertical, central axis, however the spring screw is still permitted to rotate around its central axis, for example to be screwed into the implantation site. In some embodiments of the invention, the tool is used to screw the spring screw into the implantation site, thereby securing the implant to the implantation site, while the spring member is still flexed. 
     In some embodiments of the invention, a plurality of spring screws is locked to an implantable device where it is desirable to attach the implantable device to the implantation site at a plurality of locations. 
     In an embodiment of the invention, the implantable device is placed over the implantation site with the at least one screw positioned over a location at the implantation site where it is to be secured to the patient&#39;s anatomy. The screw is then turned, drawing the implantable device towards the patient&#39;s anatomy until the implantable device is in the desired position relative to the patient. Optionally, the at least one screw is turned until the implantable device abuts the patient&#39;s anatomy. 
     In an embodiment of the invention, the implantation site is a vertebra. In some embodiments of the invention, a location is a pedicle of the vertebra. In some embodiments of the invention, a location is a facet of the vertebra. In some embodiments of the invention, a location is a lateral mass of the vertebra. 
     An aspect of an embodiment of the invention relates to a system for interlocking a screw and an implant. In an embodiment of the invention, the system comprises a spring member on the screw which in part defines a flange slot which acts as a counterpart to a flange on the implant, wherein when the flange is inserted into the flange slot, the screw and implant are interlocked. 
     There is therefore provided in an embodiment of the invention, a locking spring screw, comprising: a cylindrical screw body; a flexible spring member; and, a screw head attached to the cylindrical screw body, wherein the screw head comprises a tool slot adapted for receipt of the spring member, at least one outlet adjacent to the tool slot adapted for passage therethrough of a tongue of the spring member, and, a ridge located opposite the at least one outlet from the cylindrical screw body and at least partially around the circumference of the screw head. 
     In an embodiment of the invention, the cylindrical screw body is threaded. 
     In an embodiment of the invention, the tongue of the spring member and the ridge form a slot when the tongue is passed through the outlet. 
     In an embodiment of the invention, the length of the spring member is correlated to the amount of spring member flex allowed by a floor of the tool slot such that upon maximum flex of the spring member towards the floor, the tongue retracts at least partially into outlet. 
     In an embodiment of the invention, the maximum flex is no more than 20 thousandths of an inch. 
     In an embodiment of the invention, the tool slot and the spring member are formed as counterparts. 
     In an embodiment of the invention, the tongue and outlet diameter are narrower than the spring member. 
     In an embodiment of the invention, the ridge is sloped, increasing in size moving away from the cylindrical screw body. 
     In an embodiment of the invention, the at least one of the flexible spring member, cylindrical screw body and screw head are constructed of at least one of titanium, stainless steel, cobalt chrome, ceramic, polymer, or PEEK Optima. 
     In an embodiment of the invention, the screw length along its central axis is 8.0 mm-60.0 mm. 
     In an embodiment of the invention, the screw head is 3.5 mm-9.0 mm in diameter. 
     There is further provided in accordance with an exemplary embodiment of the invention, a system for interlocking a screw and an implant wherein the screw has motion in only one degree of freedom, comprising: an implant provided with at least one screw hole provided with a flange; and, a spring screw comprising a flexible spring member, and, a screw head attached to the cylindrical screw body, wherein the screw head comprises a tool slot adapted for receipt of the spring member, at least one outlet adjacent to the tool slot adapted for passage therethrough of a tongue of the spring member, and, a ridge located opposite the at least one outlet from the cylindrical screw body and at least partially around the circumference of the screw head, wherein when the spring member is un-flexed the tongue and the ridge form a flange slot adapted for receipt of the flange therein. 
     In an embodiment of the invention, the system further comprises a tool adapted to be a counterpart to the tool slot. 
     In an embodiment of the invention, the tool is provided with a tool hub for flexing the spring member upon insertion of the tool into the tool slot. 
     In an embodiment of the invention, the tool is provided with at least one ridge for providing torque to the spring screw for attaching the spring screw to the implantation site. In some embodiments of the invention, length of the spring member is correlated to the amount of spring member flex allowed by a floor of the tool slot such that upon maximum flex of the spring member towards the floor, the tongue retracts at least partially into outlet allowing tongue to pass flange. In some embodiments of the invention, the one degree of freedom is around a central axis of the spring screw. 
     There is further provided in accordance with an exemplary embodiment of the invention, a method of using a spring screw provided with a spring member to secure an implantable device to an implantation site, comprising: inserting the spring screw in a screw hole located on the implantable device while the spring member is flexed towards the floor of a tool slot in the screw head using a tool; advancing the spring screw until a ridge of the screw head abuts a flange of the screw hole; driving the spring screw into the implantation site; retracting the tool from the spring screw, resulting in expansion of the spring member such that a tongue portion of the spring member extends out of an outlet in the screw head, trapping the flange of the screw hole in a flange slot formed in between the tongue portion of the spring member and the ridge of the screw head. 
     In an embodiment of the invention, the method further comprises repeating inserting, advancing, driving and retracting for a plurality of spring screws. 
     In an embodiment of the invention, trapping the flange of the screw in the flange slot substantially restricts the spring screw to movement in only one degree of freedom, around its central axis. 
     In an embodiment of the invention, the implantation site is at least one of a vertebra, a pedicle of the vertebra, a facet of the vertebra, or a lateral mass of the vertebra. 
     These and other features and their advantages will be readily apparent to those skilled in the art of spinal implants from a careful reading of the Detailed Description of Exemplary Embodiments, accompanied by the following drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. In this regard, the description taken along with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced. It should also be understood that drawings may not be to scale. In the figures, 
         FIG. 1  is a perspective view of a spring screw with a flexed spring member, in accordance with an exemplary embodiment of the invention; 
         FIG. 2  is a perspective view of a spring screw with an expanded spring member, in accordance with an exemplary embodiment of the invention; 
         FIG. 3  is a cross-sectional view of a spring screw with an expanded spring member, in accordance with an exemplary embodiment of the invention; 
         FIG. 4  is a top, perspective view of a sliding spinal implant used in conjunction with at least one spring screw, in accordance with an exemplary embodiment of the invention; 
         FIG. 5  is a side view of a sliding spinal implant used in conjunction with at least one spring screw, in accordance with an exemplary embodiment of the invention; 
         FIG. 6  is a cross-sectional view of a sliding spinal implant used in conjunction with at least one spring screw, in accordance with an exemplary embodiment of the invention; 
         FIG. 7  is a flowchart showing a method of using a spring screw in conjunction with a spinal implant, in accordance with an exemplary embodiment of the invention; 
         FIG. 8  is a perspective view of a spring screw and a tool used for locking and/or unlocking the spring screw, in accordance with an exemplary embodiment of the invention; and, 
         FIG. 9  is a cross-sectional view of a spring screw and a tool used for locking and/or unlocking the spring screw flexing the spring member to unlock the spring screw, in accordance with an exemplary embodiment of the invention. 
     
    
    
     DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS 
     Throughout the application, reference is made to flexed spring member  106   a  and/or un-flexed spring member  106   b , it should be understood that these references are to the same structural element which takes two forms depending on its current state of usage with spring screw  100 . In some portions of the application, the spring member is assigned reference number  106 , it should be understood that in such instances “spring member  106 ” is referring to the element generally, whether flexed  106   a  or un-flexed  106   b.    
       FIG. 1  is a perspective view of a spring screw  100  with a flexed spring member  106   a , in accordance with an exemplary embodiment of the invention. In an embodiment of the invention, spring screw  100  is comprised of at least two general sections, a screw head  102  and a cylindrical body  104 . The cylindrical body  104 , as with most conventional screws, is the portion of the screw which is driven in to a specific attachment location at the implantation site. In some embodiments of the invention, cylindrical body  104  is provided with threading. Optionally, the threading is adapted for the type of material into which the screw will be driven. 
     Screw head  102  is provided with a tool slot  114  which is adapted for receipt of spring member  106   a  and/or to interface with a tool used for tightening and/or loosening the screw with respect to the attachment location, in an embodiment of the invention. Spring member  106   a  is shown flexed in  FIG. 1 , but it should be understood that in an embodiment of the invention, the spring member is adapted to be elastically deformed for insertion into tool slot  114  during manufacture and/or flexing during the insertion of the spring screw  100  into a spinal implant  400 , shown and described in more detail with respect to  FIG. 4 . In an embodiment of the invention, upon insertion into tool slot  114 , the spring member  106  returns to its un-flexed form  106   b , such as shown and described with respect to  FIGS. 2 and 3 . 
     In an embodiment of the invention, spring member  106  is provided with an enlarged portion, shaped like a circle in  FIGS. 1 and 2 , which prevents spring member  106  from sliding out of the at least one outlet  110 . Alternatively, additionally and/or optionally, spring member  106  is designed to be wider than outlet  110 , except the tongue  108 , which prevents spring member  106  from sliding out of outlet  110 . IN an embodiment of the invention, the spring screw  100  is designed with a tight tolerance between the tool slot  114  and the enlarged portion of spring member  106 . Optionally, the tolerance is about +/−1.5 thousands of an inch, to make sure that the screw will lock on both sides. Other shapes are usable, besides circular, in alternative embodiments of the invention. 
     A ridge  112  is provided to screw head  102  at a level where it is desired that the screw be prevented from any further insertion into the screw hole  402 , in an embodiment of the invention. In some embodiments of the invention, the ridge  112  is shaped to match a flange  404  of the screw hole  402 , the flange  404  shown and described in more detail with respect to  FIGS. 4 and 6 . For example, in an embodiment of the invention, the ridge  112  and flange  404  of the screw hole  402  are each sloped to act as complementary parts preventing over-insertion of the spring screw  100  through the screw hole  402  and/or also providing a slidable interface between the two to allow for rotation of the spring screw  100  about its vertical axis  116 . 
     Spring member  106  is provided with at least one tongue  108  which is adapted for insertion into an outlet  110  located on screw head  102 , in an embodiment of the invention. Outlet  110  is positioned on screw head  102  such that when screw head  102  is advanced fully into the screw hole  402 , the outlet  110  is positioned below the level of ridge  112 , in an embodiment of the invention. Thus, in an embodiment of the invention, when tongue  108  protrudes out of outlet  110  it creates a space between the tongue  108  and the ridge  112  for insertion of the flange  404 . In an embodiment of the invention, tongue  108  is narrower than the outlet  110  but overall spring member  106  is wider than outlet  110  so that spring member  106  cannot completely slide out of outlet  110 , only tongue  108  can. 
       FIG. 2  is a perspective view of spring screw  100  with an expanded spring member  106   b  placed within slot  114 , in accordance with an exemplary embodiment of the invention. From this perspective, it can be seen that in some embodiments of the invention, slot  114  and spring member  106  are shaped as counterparts such that spring member  106  fits snugly within the slot  114 , particularly when the spring member is in its un-flexed form  106   b . Also seen from this perspective view is the ridge  112  on the screw head  102 . In some embodiments of the invention, the ridge  112  only extends partially around the circumference of the screw head  102 , such as depicted in  FIG. 2 , however in some embodiments of the invention, the ridge  112  could extend fully around the circumference of the screw head  102 . 
       FIG. 3  is a cross-sectional view of spring screw  100  with an expanded and/or un-flexed spring member  106   b , in accordance with an exemplary embodiment of the invention. Shown in more detail is the relationship between spring member  106   b , the at least one tongue  108  of the spring member  106  and the outlet  110  adapted for passage of the tongue  108  therethrough, in an embodiment of the invention. The at least one tongue  108  transits through the outlet  110  when spring member  106   a  un-flexes to form spring member  106   b  after insertion of the spring member  106  sufficiently deep into the slot  114 . The expansion of the spring member  106  urges the at least one tongue  108  into and/or extending out of the outlet  110 . It can be seen that once the at least one tongue  108  is extended through the outlet  110 , a space  302  is created between the ridge  112  of the screw head  102  and the tongue  108 , the space being adapted and/or sized for receipt of the flange  404 , shown in more detail in  FIGS. 4 and 6 . 
     In an embodiment of the invention, spring member  106  is located above the floor  304 , of the tool slot  114  to allow for the flexing of spring member  106  during placement of the spring screw  100  into the implant  400 . In an embodiment of the invention, spring member  106  flexes approximately 20 thousands of an inch towards floor  304  during compression of spring member  106  by tool  800 . 
     In an embodiment of the invention, at least a portion of spring screw  100 , including spring member  106 , is comprised of at least one of titanium, stainless steel, cobalt chrome, ceramic, polymer (e.g. PLA, PGA), or PEEK Optima. In some embodiments of the invention, the spring screw is 8.0 mm-60.0 mm in length along the central axis  116  and/or 3.5 mm-9.0 mm in diameter (i.e. the screw head  102 ). It should be understood, however, that the spring screw  100  can be scalably sized for any application and that these size ranges are merely examples. 
       FIG. 4  is a top, perspective view of a sliding spinal implant  400  used in conjunction with at least one spring screw  100 , in accordance with an exemplary embodiment of the invention. In an embodiment of the invention, flange  404  is a part of spinal implant  400 , for example as shown in  FIG. 4 , where the flange  404  is provided around the inner circumference of screw hole  402  so that the spring screw  100  is inserted therein until the ridge  112  hits the flange  404 , in an exemplary embodiment of the invention. Also shown is a spring screw  100  inserted into a screw hole  402 , in an exemplary embodiment of the invention. 
       FIG. 5  is a side view of a sliding spinal implant  400  used in conjunction with at least one spring screw  100 , in accordance with an exemplary embodiment of the invention. From this side view, a cross-sectional is taken, which is reflected in  FIG. 6 . 
       FIG. 6  is a cross-sectional view of a sliding spinal implant  400  used in conjunction with at least one spring screw  100 , in accordance with an exemplary embodiment of the invention. From this view, it can be seen that the spring member  106   b  and the ridge  112  form a space wherein the flange  404  of the spinal implant  400  is accommodated, in an embodiment of the invention. The ridge  112  prevents the spring screw  100  from being over-inserted into the screw hole  402  and the spring member  106  prevents the spring screw  100  from being withdrawn, in essence locking the spring screw  100  into a plane relative to the spinal implant  400 . 
       FIG. 7  is a flowchart  700  showing a method of using a spring screw  100  in conjunction with a spinal implant  400 , in accordance with an exemplary embodiment of the invention. In an embodiment of the invention, spring screw  100  is inserted ( 702 ) into screw hole  402  with the spring member  106  flexed by the tool  800 , shown and described in more detail with respect to  FIG. 8 . Spring screw  100  is advanced ( 704 ) into screw hole  402  until ridge  112  of screw head  102  abuts flange  404  of implant  400 . As described elsewhere in the application, spring screw  100  is adapted so that when ridge  112  abuts flange  404 , outlet  110  is properly aligned such that when tongue  108  of un-flexed spring member  106   b  extends out of outlet  110 , flange  404  is bracketed by tongue  108  and ridge  112 . 
     In some embodiments of the invention, spring screw  100  is driven ( 706 ) into the hard tissue at the implantation site to attach the implant  400  to the patient, for example by using tool  800  to screw spring screw  100  into place. Optionally, spring member  106  remains flexed during the driving, although in some embodiments of the invention, the tool is retracted slightly prior to commencing the driving. Tool  800  is retracted ( 708 ) from tool slot  114 , causing spring member  106  to un-flex and projecting at least one tongue  108  through outlet  110 , locking spring screw  100  into a plane corresponding to the flange  404 , in an embodiment of the invention. 
     In some embodiments of the invention, depending on how many screw holes are present on the implant and/or depending on the specific implantation needs of the implant with respect to the patient, more than one screw is used to secure the implant to the patient. Accordingly, inserting ( 702 ), advancing ( 704 ), driving ( 706 ) and retracting ( 708 ) are optionally repeated ( 710 ) for each screw in some embodiments of the invention. 
     It should be understood that in some embodiments of the invention, screw is not necessarily advanced ( 704 ) until ridge  112  abuts flange  404  but rather is advanced ( 704 ) only as far as required to place outlet  110  past flange  404  such that when tongue protrudes out of screw head  102  the flange  404  is bracket by tongue  108  and ridge  112 . It should also be understood that implant  400  is merely exemplary and that spring screw  100  could be used with any implant or device adapted for use with the spring screw  100 . For example, any implant or device with a flange in a screw hole which could be bracketed by ridge  112  and tongue  108 . 
     Referring to  FIG. 8 , a perspective view of spring screw  100  and a tool  800  used for locking and/or unlocking spring screw  100  is shown, in accordance with an exemplary embodiment of the invention. In an embodiment of the invention, tool  800  is adapted to act as a counterpart to tool slot  114  in spring screw head  102  to tighten and/or loosen spring screw  100  and/or to flex spring member  106  for locking spring screw  100  to implant  400 . For example, a tool nub  802  is provided to tool  800  wherein tool nub  802  is sized to fit within tool slot  114  located in spring screw  100  and extend at least as far into tool slot  114  as is required to flex spring member  106  to floor  304 , in an exemplary embodiment of the invention. Ridges  804  also be provided to tool  800  which assist in applying torque to spring screw  100  during tightening and/or loosening of the spring screw  100  from the implantation site. It should be understood, that tool  800  is merely an example of what could be used for flexing the spring member  106  and/or driving the screw into the implantation site. For example, any tool which fits within the slot (which as described above is variable in shape), is capable of extending into the slot far enough to flex the spring and/or is capable of applying torque to the screw sufficient for securing it to the implantation site, could be used. 
       FIG. 9  is a cross-sectional view of spring screw  100  and tool  800  used for locking and/or unlocking spring screw  100  by flexing the spring member  106  to unlock the spring screw  100  into implant  400 , in accordance with an exemplary embodiment of the invention. It can be seen that tool nub  802  of tool  800  exerts a force on spring member  106  such that it flexes towards floor  304 . The flexing of spring member  106  causes its overall length relative to spring screw  100  to shorten, withdrawing the at least one tongue  108  into outlet  110 , but not so far as to cause spring member  106  to become dislodged from the outlet  110 . The retraction of spring member  106  allows for outlet  110  of spring screw  100  to be inserted into implant  400  past flange  404 , in an embodiment of the invention. 
     Unless otherwise defined, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and/or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting. 
     The terms “comprises”, “comprising”, “includes”, “including”, “having” and their conjugates mean “including but not limited to”. This term encompasses the terms “consisting of” and “consisting essentially of”. 
     The phrase “consisting essentially of” means that the composition or method may include additional ingredients and/or steps, but only if the additional ingredients and/or steps do not materially alter the basic and novel characteristics of the claimed composition or method. 
     As used herein, the singular form “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof. 
     Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range. 
     Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases “ranging/ranges between” a first indicate number and a second indicate number and “ranging/ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween. 
     As used herein the term “method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts. 
     It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements. 
     Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. 
     All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting 
     Those familiar with implantable devices and apparatuses and methods for attaching them to a patient&#39;s anatomy will appreciate that many modifications and substitutions can be made to the foregoing preferred embodiments of the present invention without departing from the spirit and scope of the present invention, defined by the appended claims.