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, such as 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.
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 on 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's anatomy. The screw is then turned, drawing the implantable device towards the patient'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'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 the 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 sidewalls of a screw head screw hole are 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; 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 the 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.
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,
Throughout the application, reference is made to flexed spring member 106A and/or un-flexed spring member 106B; 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 106A or un-flexed 106B.
Screw head 102 is provided with a tool slot 114 which is adapted for receipt of spring member 106A 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 106A is shown flexed in
In an embodiment of the invention, spring member 106 is provided with an enlarged portion, shaped like a circle in
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
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. 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.
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.
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 project 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
In another embodiment of the invention as depicted by
Screw head 202 is provided with a tool slot 214 which is adapted for receipt of spring member 206 to interface with a tool 500 used for tightening and/or loosening the screw 200 with respect to the attachment location. Spring member 106 is shown un-flexed in
Upon insertion of the end 230 of the tool 500 into tool slot 214, the spring member 206 is engaged to flex for temporary placement while the screw is being inserted. The spring member 206 can be provided with an enlarged portion, shaped like a circle in
A sidewall 212 is provided to screw head 202 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 sidewall 212 is shaped to match the screw hole 452 sidewall of the screw hole 402. For example, in an embodiment of the invention, the sidewall 452 is sloped to act as complementary parts preventing over-insertion of the spring screw 200 through the screw hole 452 and/or also providing a slidable interface between the two to allow for rotation of the spring screw 200 about its vertical axis 216.
Spring member 206 is provided with at least one tongue 208 which is adapted for insertion into an outlet 210 located on screw head 202, in an embodiment of the invention. Outlet 210 is positioned on screw head 202 such that when screw head 202 is advanced fully into the screw hole 402, the outlet 210 is positioned below the level angular shape of the sidewall 212. The spring member 206 operates as a leaf spring when placed biased, and is substantially flat when in a natural state extended position.
In an embodiment of the invention, spring member 206 is located above the cavity 242 of the tool slot 214 to allow for the flexing of spring member 206 during placement of the spring screw 200 into the implant 450. In an embodiment of the invention, spring member 206 flexes approximately 20 thousands of an inch towards cavity 242 during compression of spring member 206 by tool 500.
In an embodiment of the invention, at least a portion of spring screw 200, including spring member 206, 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 216 and/or 3.5 mm-9.0 mm in diameter (i.e. the screw head 202). It should be understood, however, that the spring screw 200 can be scalably sized for any application, and that these size ranges are merely examples.
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 indicated number and a second indicated number and “ranging/ranges from” a first indicated number “to” a second indicated 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'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.
In accordance with 37 C.F.R. 1.76, a claim of priority is included in an application Data Sheet filed concurrently herewith. Accordingly, the present invention claims priority as a continuation-in-part of U.S. patent application Ser. No. 12/971,579, filed Dec. 17, 2010, entitled “Spring Screw Apparatuses and Methods of Using Same”. The content of the above referenced application is incorporated herein by reference in its entirety.
Number | Date | Country | |
---|---|---|---|
Parent | 12971579 | Dec 2010 | US |
Child | 15206698 | US |