Patent Application
20150250515
The present disclosure relates to systems, apparatuses, methods, and kits for joint repair. Specifically, this disclosure relates to syndesmosis fixation apparatuses, systems, kits, and methods suitable to accommodate or correct various patient deformities.
A syndesmosis joint is formed by an interosseous membrane connecting the fibula to the tibia. The syndesmosis joint is a slightly movable articulation where the contiguous bony surfaces are united by the interosseous ligament. If undue stress is put on the ankle joint, the joint may fracture, with either the fibula or tibia fracturing, or possibly both. Syndesmotic injuries to the ankle occur in approximately 10% of cases of ankle fractures. However, these injuries can also occur with soft-tissue injuries in the absence of fracture. They usually result from severe external rotation of the ankle. If the syndesmosis is torn apart, the syndesmosis joint needs to be stabilized by holding the joint in position until the articulation heals. Surgeons often fix the relevant bones together with a syndesmotic screw, temporarily replacing the syndesmosis. The screw inhibits normal movement of the bones and, therefore, the corresponding joint. When the natural articulation is healed, the screw may be removed. Alternatively, surgeons use an elastic fiber wire loop tensioned and secured between metallic buttons to provide physiologic stabilization of the joint. This technique allows physiologic motion of the ankle.
However, the syndesmotic screws are prone to fracture at the fulcrum of the screw around which the fibular side of the screw rotates during gait because they are inflexible in all degrees of freedom. Further, the elastic fiber wire loop may cause an inflammatory reaction, and the buttons used in the fixation may cause soft tissue irritation. Therefore, the existing systems and procedures for syndesmosis repair may not be as effective as desired.
The present disclosure relates to bone and joint fixation, and instrumentation and methods for preparation and implantation of these devices. Joint fixation may be necessary in cases of pain and inflammation due to cartilage degeneration, nerve impingement, spinal misalignment, and motion instability. The primary examples described herein illustrate how this concept is applied to the syndesmosis joint, but this concept applies equally to other joints where similar causes of pain and inflammation are indicated. The disclosed bone screw includes a first screw element and a second screw element inserted through the first screw element and engaged therewith. Each of the first screw element and second screw element include an external thread for threaded engagement with a bone. Further, the first screw element is capable of being selectively adjusted to achieve a required compression. The bone screw when secured to the tibia and the fibula provides resistance to distraction of the syndesmosis joint. The disclosed bone screw has a low profile and is less expensive than other systems. Further, the disclosed bone screw is intrinsically stronger than a standard screw as it provides only a limited resistance to bending movement.
Those of skill in the art will recognize that the following description is merely illustrative of the principles of the disclosure, which may be applied in various ways to provide many different alternative embodiments and may be applicable outside the fields of surgery or medical devices. While the present disclosure is made in the context of syndesmosis joints for the purposes of illustrating the concepts of the design, it is contemplated that the present design and/or variations thereof may be suited to other uses, such as to support other joints in the human body and to stabilize bone fractures. Moreover, the implants, instrumentation, and methods set forth herein may be used in open, percutaneous, and/or minimally invasive procedures.
All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.
Various embodiments of the present disclosure will now be discussed with reference to the appended drawings. It will be appreciated that these drawings depict only typical examples of the present disclosure and are, therefore, not to be considered limiting of its scope.
While certain embodiments are shown and described in detail below by way of illustration only, it will be clear to the person skilled in the art upon reading and understanding this disclosure that changes, modifications, and variations may be made and remain within the scope of the technology described herein. Further, while various features are grouped together in the embodiments for the purpose of streamlining the disclosure, it is appreciated that features from different embodiments may be combined to form additional embodiments which are all contemplated within the scope of the disclosed technology.
Not every feature of each embodiment is labeled in every figure where that embodiment appears, in order to keep the figures clear. Similar reference numbers (for example, those that are identical except for the first numeral) may be used to indicate similar features in different embodiments.
Any of the devices described herein may be fabricated from metals, alloys, polymers, plastics, ceramics, glasses, composite materials, or combinations thereof, including but not limited to: PEEK, titanium, titanium alloys, commercially pure titanium grade 2, ASTM F67, Nitinol, cobalt chrome, stainless steel, UHMWPE, and biodegradable materials, among others. Different materials may be used within a single part. The implants disclosed herein may also encompass a variety of surface treatments or additives to encourage bony attachment, including but not limited to: porous coatings, hydroxyapatite, TCP, anti-microbial additives, analgesics, anti-inflammatories, BMP's, PMA material, bone growth promoting material, PLLA (poly-L-lactide), PGA (polyglycolide), TCP (tricalcium phosphate), demineralized bone, cancellous bone chips, etc. Any implant disclosed herein may include a radiographic marker for imaging purposes. Any implant disclosed herein may be colored, coded, or otherwise marked to make it easier for the surgeon to identify the type and size of the implant.
Further, the first screw element 102 includes a self-tapping feature 114 (or self-threading) to tap a drilled hole when the bone screw 100 is inserted into the one or more bones. Similarly, the second screw element 104 includes a self-tapping feature 116. Further, the second screw element 104 is cannulated down its center so that it can be placed into the one or more bones with a Kirschner wire (K-wire). The first screw element 102 and the second screw element 104 are explained in further detail in conjunction with
Referring now to
As shown in
In a second example depicted in
Referring back to
Further, the first screw element 102 and the second screw element 104 may engage using one of a ball joint, a yoke joint, a universal joint, and a flat slider plate joint. Accordingly, the first screw element 102 and the second screw element 104 are suitably modified to engage with the used joint. Alternatively, a dumbbell element is placed between the first screw element 102 and the second screw element 104. The first screw element 102 and the second screw element 104 are suitably modified to receive one ball of the dumbbell element each, with a similar partial spherical-shaped capsule as described in conjunction with
Referring now to
Referring now to
Referring now to
A bone screw kit or system comprises a plurality of bone screws, wherein each bone screw includes a first screw element and a second screw element inserted through the first screw element and engaged therewith. The kit further includes at least one drill to provide clearance for both the first screw element and the second screw element in at least one bone, a first driver to drive the bone screw into the at least one bone, such that external thread on each of the first screw element and second screw element engages with the at least one bone, wherein the first driver is a stepped driver and the second driver selectively adjusts the first screw element to achieve a required compression.
Further, the at least one drill of the bone screw kit includes a cannulated major drill to provide clearance for the shaft of the second screw element, a cannulated minor drill to provide clearance for the threaded portion of the second screw element and a cannulated reamer to provide clearance for the first screw element.
Moreover, each bone screw in the kit is of a different configuration, wherein the configuration of a bone screw is defined by one or more parameters including a major diameter, a pitch, a length, a lag thread, and a drive connection. The bone screw kit may further include one or more of a K-wire, one or more tapping tools capable of accommodating all bone screws in the kit, and one or more driving tools.
As shown, the bone screw 100 when installed in the bones has a zero profile, which helps reduce irritation to surrounding soft tissue. Further, the fibula 1006 provides a measure of resistance to disengagement of the first screw element 102 and the second screw element 104. In addition, the joint between the first screw element 102 and the second screw element 104 allows for normal fibular motion, thereby reducing the chances of fracture of the bone screw 100. Further, the first screw element 102 may be selectively adjusted to fine-tune the syndesmosis compression.
A method 1100 of inserting the bone screw 100 into the pair of bones, including a first bone and a second bone as disclosed herein, is described in
Next at step 1104, the surgeon guides a cannulated major drill over the guide wire to drill through the fibula 1006 and then through the tibia 1004. The major drill provides clearance for the shaft 108 (major diameter) of the second screw element 104. Then at step 1106, the surgeon uses a cannulated minor drill to provide clearance for threaded portion 110 (minor diameter). Further, at step 1108, the surgeon uses a fibular reamer to ream the fibula to provide clearance for the first screw element 102. The cannulated major drill, the cannulated minor drill and fibular reamer may be manually operated or may be operated by, or as, powered devices.
Once the implant site is sufficiently prepared to receive the bone screw 100, the guide wire is used to orient and insert the bone screw 100 into the fibula 1006 and the tibia 1004, at step 1110. The surgeon uses a first screwdriver that engages with both the first screw element 102 and the second screw element 104 to insert the bone screw 100 into the fibula 1006 and the tibia 1004. For example, if the bone screw 100 has a drive arrangement as shown in
Finally, at step 1112, the surgeon selectively adjusts the first screw element 102 to achieve a required compression between the bones. The surgeon uses a second screwdriver to selectively adjust the first screw element 102. The second screwdriver engages the first screw element 102 only. For example, if the bone screw 100 has a drive arrangement as shown in
Once the bone screw 100 is in the proper location, the surgeon can remove the guide wire, the drivers, and any other instrumentation used, and then close the incision site.
It should be understood that the present components, systems, kits, apparatuses, and methods are not intended to be limited to the particular forms disclosed. Rather, they are intended to include all modifications, equivalents, and alternatives falling within the scope of the claims. They are further intended to include embodiments which may be formed by combining features from the disclosed embodiments, and variants thereof.
The claims are not to be interpreted as including means-plus- or step-plus-function limitations, unless such a limitation is explicitly recited in a given claim using the phrase(s) “means for” or “step for,” respectively.
The term “coupled” is defined as connected, although not necessarily directly, and not necessarily mechanically.
The use of the word “a” or “an” when used in conjunction with the term “comprising” in the claims and/or the specification may mean “one,” but it is also consistent with the meaning of “one or more” or “at least one.” The term “about” means, in general, the stated value plus or minus 5%. The use of the term “or” in the claims is used to mean “and/or” unless explicitly indicated to refer to alternatives only or the alternative are mutually exclusive, although the disclosure supports a definition that refers to only alternatives and “and/or.”
The terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has” and “having”), “include” (and any form of include, such as “includes” and “including”), and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a method or device that “comprises,” “has,” “includes,” or “contains,” one or more steps or elements, possesses those one or more steps or elements, but is not limited to possessing only those one or more elements. Likewise, a step of a method or an element of a device that “comprises,” “has,” “includes,” or “contains” one or more features, possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed.
The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. It is appreciated that various features of the above-described examples can be mixed and matched to form a variety of other alternatives. As such, the described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.
