1. Field of the Invention
The present invention has to do with surgical fasteners which are implanted in the body. In particular, the invention has to do with self-locking surgical screws which do not back out after they are implanted. The screws are particularly suitable for affixing plates and other implant devices in a patient.
2. The Related Art
Screws presently used for fastening implants to a bone rely on the screw obtaining solid purchase in the bone and holding down the implant tightly against the bone. The compression of the implant to the bone provides a rigid connection which allows the forces (stresses) to be transferred from the bone to the implant. If this compression is lost, then the transference of force to the implant is reduced or even lost completely. But bones can be weak or have weak portions and motion or repeated forces can cause the screws to back out, thus loosening the implant, potentially making it ineffective and/or causing pain or infection, or impinging on internal structures in the patient. An additional surgical procedure may be required as a result.
Bone generally has an outer cortical shell which is hard and strong. The portion of the bone under the cortical shell is cancellous bone, which is a much softer material. This characteristic of bone structure creates problems in surgery because much of the length of the screw often is fixed in this weaker cancellous bone. Conventional surgical screws can loosen and become unstable, for example, they may rotate over time in the loosening direction (termed “backout”) or pull out requiring a second or revision surgery or the patient may have weak bone tissue or bones weakened by disease such as osteoporosis so that the bones are not strong enough to hold a tightly seated screw.
Self-locking surgical screw systems have been designed to overcome these problems because a self-locking screw is prevented from rotating and thereby backing out of a bone. U.S. Pat. No. 5,951,558, for example, describes a bone fixation device comprising a fixation plate and screws in combination with a screw locking or blocking mechanism which is arranged to prevent the screws from backing out after they are passed through the plate and screwed into the bone. This device requires a combination of screws with a specially designed plate. The design prevents gross screw backout but still allows a small amount of loosening which can be clinically significant.
Other devices for locking surgical screws in place require a threaded screw hole in the implant device which receives a specially designed screw with a threaded head. In these devices the screw must be inserted at a pre-determined fixed angle with respect to the implant. A few examples of devices embodying this design are illustrated in U.S. Pat. Nos. 5,709,686, 5,954,722, 6,623,486 and 6,821,278.
The self-locking screw assemblies of the present invention do not require a specially designed implant device or threaded screw holes in the implant device. The screws of the invention can be used in place of standard implant screws in conventional implant devices. Another advantage of the screws of the invention is that they can be installed on an angle that is most suitable to the surgical procedure and, if desired, they can be used in combination with screws that are not self-locking. For example, in a bone plate requiring several screws, some of the screws can be conventional and others can be self-locking.
The invention has to do with self-locking screws for fastening a medical implant to a bone, combinations of self-locking screws and implants, devices implanted with self-locking screws and related methods. Each self-locking screw assembly is comprised of a non-threaded head affixed to a shank, a threaded portion on the shank, a neck on the shank between the head and threaded portion and a locking device externally affixed to or disposed on the head, the neck or both the head and the neck. The locking device lockingly engages the head and/or neck of the screw when the screw is in fastening engagement with the medical implant and the bone. When the locking device engages only the head, the neck can be the portion of the screw where the head transitions to the threaded portion.
The surgical applications for use of the self-locking screws of the invention are numerous. They are useful in any application where a surgeon might need a means to repair or rebuild a bone, attach cartilage or a tendon to a bone, and the like. For example, the screws can be inserted through the top tibial trays, can be used to hold down trauma plates, artificial joints, other plates and mesh materials, acetabulum cups, and the like.
The drawings are intended to be illustrative, are not drawn to scale and are not intended to limit the scope of the claims to the embodiments depicted.
The purpose of the self-locking screw assemblies of the invention is to prevent the screws from loosening and backing out of the bone and/or the medical implant. In a typical application, the medical implant is a plate for joining broken bones. Backing out would allow the plate to come loose which could lead to non-fusion (non union) or improper fusion (malunion) of the pieces of bone being joined. There is also the problem of screws which have backed out irritating the soft tissue or impinging upon major arteries, veins or other internal body structures. The self-locking screw assemblies of the invention are intended to be used with existing medical implants which are attached to the bone of a patient by screws. Thus, the screws of the invention are intended to work with standard (non-locking) hole details found in the majority of bone plates and other implant devices manufactured today. This style of screw can simply be added to a set of hospital inventory without requiring the addition of matching plates.
The self-locking screws of the invention are designed to permit angulation and subsidence while still preventing back out. In some cases, postoperatively it is advantageous to allow the screws to change angle relative to the bone plate to accommodate remodeling of the bony ends during the fusion process. This remodeling can lead to minute shortening of the bony ends. In cases such as this, allowing the construct to subside and maintain bony contact, rather than causing the construct and the bone to be rigidly held apart, can aid in achieving fusion.
Self-locking screw assemblies of the invention can be made of various biocompatible materials and combinations of biocompatible materials. For example, the head, shaft, threads and locking device of a particular self-locking screw assembly can be made from the same materials or different materials so that one portion will be absorbed by the body more quickly than another or one portion will be absorbed and the other will not. In this manner, a self-locking screw can be constructed that remains tightly locked during the time required for bones to fuse, but then the locking device degrades over time to permit removal or allow the implant to be unloaded to prevent stress shielding of the bone. Stress shielding is the redistribution of load (and consequently the stress on the bone) as a result of an implant. Metallic implants can be significantly stiffer than bone and as a result, the normal stresses are altered in that region, sometimes causing complications. In the case of a bone plate used to bridge a fractured bone, the bone plate redistributes the load around the fracture. While this is helpful in the early stages of bone healing, as bony fusion progresses and stability across the fracture increases, it would be beneficial for the implant to bear progressively less of the load. Alternatively, the screws or portions of the screws and/or locking device can be coated as described in our copending application Ser. No. 11/025,213, filed Dec. 29, 2004, the disclosure of which is incorporated by reference herein in its entirety. Other variations and combinations of materials that can be used to make the products of the invention will be apparent to those having skill in the art. Suitable materials include biocompatible metals, alloys, polymers and reinforced polymers, both resorbable and nonresorbable, as well as organic materials such as collagen or alloplastic substances which are commonly used in surgical implants of all kinds. Such materials include materials that have sufficient strength to meet the objectives of the invention and that have been approved by the United States Food and Drug Administration (FDA) for surgical implant applications.
Generally speaking, there are three main types of alloys used in orthopedic implants today, titanium alloys, cobalt alloys and stainless steel alloys. An exhaustive list is available on the FDA website which also provides the reference numbers and effective dates of the ASTM or ISO standards for the materials. Some examples include unalloyed and alloyed titanium, molybdenum, chromium, cobalt, tungsten, aluminum, niobium, manganese or vanadium in various combinations as alloys or components of alloys, various stainless steels and other iron alloys, aluminum oxides, zirconium oxides, tantalum and calcium phosphates.
Numerous types of polymers also are employed to make implants and many of these are identified not only on the FDA website mentioned above but also on the ASTM website. Examples of suitable polymers include polyetheretherketone (PEEK), epoxys, polyurethanes, polyesters, polyethylenes, vinyl chlorides, polysulfones, polytetrafluoro-ethylene (PTFE), polycarbonates, polyaryletherketone (PAEK), polyoxymethylene, nylon, carbon fiber polyester, polyetherketoneetherketoneketone (PEKEKK), silicones, hydrogels and the like. When a polymer is used, a small wire or other material can be incorporated in the main body of the base for purposes of x-ray detection.
The foregoing lists of materials may have application in some embodiments of the present invention but not in others as will be apparent to those skilled in the art based on requirements of strength, flexibility, machinability and the like for the particular application. The lists are intended to be illustrative and not exhaustive. Other materials and new materials may be employed based upon the principles of the invention as set forth herein.
For purposes of this specification, the term “polymer” is defined as any biocompatible non-bioabsorbable polymer, copolymer, polymer mixture, plastic or polymer alloy having sufficient strength to withstand without failure the torques and stresses that a self-locking screw of the invention would normally be subjected to during surgery or in the body.
Bioabsorbable or resorbable material can also be used to make all or a portion of one or more of the component parts of the self-locking screw assemblies of the invention and/or the bioabsorbable material can be applied as a partial or complete coating on such component parts.
The terms “bioabsorbable material” and “resorbable material” as used herein includes materials which are partially or completely bioabsorbable in the body.
Suitable bioabsorbable and resorbable materials (also referred to herein as “bioabsorbables”) include polyglycolide, poly(lactic acid), copolymers of lactic acid and glycolic acid, poly-L-lactide, poly-L-lactate; crystalline plastics such as those disclosed in U.S. Pat. No. 6,632,503 which is incorporated herein by reference; bioabsorbable polymers, copolymers or polymer alloys that are self-reinforced and contain ceramic particles or reinforcement fibers such as those described in U.S. Pat. No. 6,406,498 which is incorporated herein by reference; bioresorbable polymers and blends thereof such as described in U.S. Pat. No. 6,583,232 which is incorporated herein by reference; copolymers of polyethylene glycol and polybutylene terephthalate; and the like. The foregoing list is not intended to be exhaustive. Other bioabsorbable materials can be used based upon the principles of the invention as set forth herein.
Bioactive materials can be admixed with the bioabsorbable or resorbable materials, impregnated in such materials and/or coated on the outer surface thereof and/or coated on any other portion of the products of the invention. These materials can include, for example, bioactive ceramic particles, bone chips, polymer chips, capsules or reinforcement fibers and they can contain, for example, antimicrobial fatty acids and related coating materials such as those described in Published U.S. Patent Application No. 2004/0153125 A1; antibiotics and antibacterial compositions; immunostimulating agents; tissue or bone growth enhancers and other active ingredients and pharmaceutical materials known in the art.
The products of the invention can be made by molding, heat shrinking or coating a bioabsorbable material on a base or substrate which has been provided with attachment means such as those described in our pending patent application Ser. No. 11/025,213 filed Dec. 29, 2004 which is incorporated herein as referenced above. When the bioabsorbable material will have functional mechanical properties, the bioabsorbable material can be molded onto a suitable metallic or polymeric substrate in the desired shape. Alternatively, the bioabsorbable material also can be coated, shrink wrapped or molded onto a substrate. If necessary, the bioabsorbable material can be machined to the desired shape and/or dimensions.
The self-locking screw assemblies of the invention are inserted through a hole in a medical implant device. They can comprise self-drilling screws which are screwed into the operating area of a patient with little or no pre-drilling or they can comprise self-tapping screws which can be implanted in pre-drilled holes in the operating area of a patient. The operating area is usually in bone but it can be in cartilage and bone when a means (e.g., a washer, plate, bracket, wire or equivalent) is used to hold the cartilage down. If a pre-drilled hole is used, it is sized to accommodate the self-locking screw so that the implant device will ultimately be implanted in the manner deemed most desirable by the surgeon. It will be understood that sizing the hole means the hole itself and any countersinking that may be desired are drilled in a manner that will cause the self-locking screw and implant device to be securely affixed in the patient during surgery.
As will be apparent to those skilled in the art, the sizes of the self-locking screws of the invention can be varied over a broad range to meet their intended applications. In most cases the self-locking screw assemblies of the invention will work with plates presently on the market. Additionally, in most cases the head style of the self-locking screws which we have illustrated as spherical can be changed to match head styles presently on the market as will be apparent to those having ordinary skill in the art. The drive style can be a slotted or hexagon drive, cruciform or others, as will also be apparent to those having skill in the art.
A typical screw hole in a bone plate has a larger opening on the upper side of the plate and a smaller opening on the bottom side (the side adjacent the bone) and the hole is shaped to accommodate the head of the screw. If the plug passes partially through the bone plate it will also interfere with the smaller portion of the hole at the bottom of the plate thereby causing the screw to resist back out. With this design, however, the screw can be backed out with the forces applied by a tool such as a screw driver. An expanded view of this embodiment is illustrated in