Patent Application
20230270452
This document relates to the field of fracture stabilization, ankle arthritis, and joint arthrodesis. More particularly, this document pertains to the fusion of the tibiotalar joint with an intramedullary device while leaving the talocalcaneal or subtalar joint intact.
The incidence of geriatric ankle fractures is increasing with the aging population, there is no consensus on the optimal management of these fractures. Current treatment methods of open reduction are invasive and require prolonged periods of immobilization. Tibio-talar-calcaneal nails violate the subtalar joint. A tibio talar nail would allow for fracture stabilization and immediate weight bearing.
When operative intervention is used to treat ankle arthritis, there are two main options: ankle replacement and ankle fusion. Ankle fusion can be performed using either a plate or intramedullary nail. The benefit of using a plate for ankle fusion is that you can isolate the fusion to the tibiotalar (TT) joint and leave the talo-calcaneal (TC) joint untouched. However, the use of a plate requires more extensive dissection and the implant does not provide enough stability to allow for immediate weight bearing. The benefit of using a nail for tibiotalar fusion is that it allows for immediate weight bearing and requires less dissection for exposure. The downside to modern intramedullary nails currently used for ankle fusion is that the implant traverses the calcaneus, talus, and tibia, resulting in a fusion between the subtalar joint which is often unnecessary.
Patients who undergo tibiotalar joint fusion with a plate are generally non-weight bearing for 6 weeks or longer after surgery. This period of non-weight bearing results in muscle atrophy, deconditioning, and increases risk of deep vein thrombosis (DVT) or pulmonary embolism (PE). These patients are also typically casted for 8-12 weeks after surgery, which can lead to skin irritation or breakdown. The increased dissection required for plate placement leads to increased disruption of blood supply and wounds which take longer to heal, which is particularly troublesome in diabetic patients who represent a growing segment of patients needing ankle fusion.
While patients who undergo tibiotalar and subtalar fusion get the benefit of immediate weight bearing and easier healing wounds, they must deal with the aftermath of a fused subtalar joint. Studies have demonstrated that subtalar fusion results in loss of motion and gait instability. A normal subtalar joint is capable of subtalar compensation, resulting in improved lower extremity alignment in the setting of ankle or knee deformity. Fusion of the subtalar joint results in a loss of subtalar compensation, exacerbating or even unmasking issues caused by deformity in the knee or ankle.
The ideal implant for ankle fusion would be an intramedullary nail that did not also fuse the subtalar joint. The tibiotalar fusion nail allows for immediate weight bearing, causes minimal soft tissue disruption, and preserves subtalar compensation by leaving the subtalar joint intact.
A cadaveric study was performed demonstrating safety of inserting the tibiotalar fusion nail, as flexor hallucis longus (FHL) was not disrupted. Furthermore, the study showed that the subtalar joint remained intact. Based on the nail entry site, implanting the tibiotalar fusion nail is also safe for the lateral plantar nerve and artery.
In accordance with the purposes and benefits described herein, a method is provided for fusing a tibiotalar joint of a patient with an intramedullary device while leaving adjacent talocalcaneal or subtalar joint intact. That method comprises the steps of: (a) placing an intramedullary nail through a talus and into a tibia of the patient without violating a posterior facet of the adjacent subtalar joint and (b) fixing the intramedullary nail to the talus and the tibia.
In one or more embodiments, the method further includes the step of compressing the tibiotalar joint. In one or more embodiments, the method further includes the step of using a guidewire for the placing of the intramedullary nail. The method may also include starting the guidewire just medial to a main body of a calcaneus at a planar aspect of a sustentaculum tali. Further, the method may include the step of inserting the guidewire through the calcaneus into the talus and the tibia.
The method may include the step of reaming the talus and the tibia over the guidewire by advancing through the sustentaculum tali and into an inferior aspect of the talus without violating the posterior facet of the subtalar joint. The method may also include the step of inserting the intramedullary nail into the talus and the tibia through the sustentaculum tali.
In one or more embodiments, the method includes the step of making a plantar incision over the guidewire and placing a retractor medial to a sustentaculum to protect the flexor hallucis longus tendon and the adjacent neurovascular bundle prior to the reaming. The method may also include the step of placing a drill sleeve over the guidewire prior to reaming in order to protect soft tissue.
Still further, the method may include one or more of any of the following steps:
In accordance with yet another aspect, a method for fusing a tibiotalar joint of a patient with an intramedullary device while leaving the adjacent talocalcaneal or subtalar joint intact, comprises: (a) inserting an intramedullary nail through the calcaneus just medial to a main body of a calcaneus at a planar aspect of a sustentaculum tali into a talus and a tibia of the patient without violating a posterior facet of the adjacent subtalar joint and (b) fixing the intramedullary nail to the talus and the tibia.
In one or more embodiments, the method further includes the step of compressing the tibiotalar joint. In one or more embodiments, the method further includes the step of using a guidewire for the placing of the intramedullary nail. The method may also include starting the guidewire just medial to a main body of a calcaneus at a planar aspect of a sustentaculum tali. Further, the method may include the step of inserting the guidewire into the talus and the tibia.
The method may include the step of reaming the talus and the tibia over the guidewire by advancing through the sustentaculum tali and into an inferior aspect of the talus without violating the posterior facet of the subtalar joint. The method may include the step of making a plantar incision over the guidewire and placing a retractor medial to a sustentaculum to protect the flexor hallucis longus tendon and the adjacent neurovascular bundle prior to the reaming. The method may also include the step of placing a drill sleeve over the guidewire prior to reaming in order to protect soft tissue.
Still further, the method may include one or more of any of the following steps:
In accordance with yet another aspect, a fused tibiotalar joint, comprises an intramedullary nail extending through a talus and into a tibia of the patient without violating a posterior facet of the adjacent talocalcaneal or subtalar joint.
The fused tibiotalar joint may include at least one screw fixing the intramedullary nail to the tibia. That screw may be placed proximally.
The fused tibiotalar joint may include at least one screw fixing the intramedullary nail to the talus. That screw may be placed in a trans malleolar fashion for stability.
The fused tibiotalar joint may include a compression screw fixed in the tibia and the talus outside of the intramedullary nail. Alternatively, the fused tibiotalar joint may include a compression screw built within the intramedullary nail at the proximal extent of the intramedullary nail.
In the following description, there are shown and described several preferred embodiments of the method of fusing a tibiotalar joint with an intramedullary nail while leaving the talocalcaneal or subtalar joint intact and the resulting fused tibiotalar joint. As it should be realized, the method and fused tibiotalar joint are capable of other, different embodiments and their several details are capable of modification in various, obvious aspects all without departing from the method and fused tibiotalar joint as set forth and described in the following claims. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not as restrictive.
The accompanying drawing figures incorporated herein and forming a part of the specification, illustrate several aspects of the method of fusing a tibiotalar joint with an intramedullary nail while leaving the talocalcaneal or subtalar joint intact and the resulting fused tibiotalar joint and together with the description serve to explain certain principles thereof.
Reference will now be made in detail to the present preferred embodiments of the method of fusing a tibiotalar joint with an intramedullary nail while leaving the talocalcaneal joint or subtalar intact as well as the resulting fused tibiotalar joint, examples of which are illustrated in the accompanying drawing figures.
Accordingly, it is to be understood that the embodiments of the method of fusing a tibiotalar joint with an intramedullary nail while leaving the talocalcaneal or subtalar joint intact and the resulting fused tibiotalar joint 10 set forth and described herein are merely illustrative and not restrictive. Reference herein to details of the illustrated embodiments is not intended to limit the scope of the claims. As used herein, the term “and/or” includes “and” and all combinations of one or more of the associated listed items. As used herein, the singular forms “a”, “an,” and “there” are intended to include the plural forms as well as the singular forms, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof.
Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one having ordinary skill in the art to which this device and method belong. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and the present disclosure and will not be interpreted in an idealized overly formal sense unless expressly so defined herein.
In describing the method and the fused tibiotalar joint 10, it will be understood that a number of techniques and steps are disclosed. Each of these have individual benefit and each can also be used in conjunction with one or more, or in some cases all, of the other disclosed techniques. Accordingly, for the sake of clarity, this description will refrain from repeating every possible combination of the individual steps in an unnecessary fashion. Nevertheless, the specification and claims should be read with the understanding that such combinations are entirely within the scope of this document and the claims.
Reference is now made to
Reference is now made to
As best illustrated in
The nail 12 may be constructed from implantable stainless steel alloys but could also be constructed of implantable grade titanium alloys, as well. Other material having the requisite properties of strength and inertness may be used.
As illustrated in
In the illustrated embodiment, (a) the first fastener locator 44 aligns the first interlocking screw 46 with the first aperture 22, (b) the second fastener locator 48 aligns the second interlocking screw 50 the second aperture 24 and (c) the third fastener locator 52 aligns the third interlocking screw 54 with the third aperture 26. A guide sleeve (not shown), of a type known in the art, may be inserted into each fastener locator 40 to aid in the placement of the fasteners 42 in a manner known in the art (see US 2020/0113609).
In at least one possible embodiment, the tibiotalar nail implant system 10 includes a outrigger extension 56 that is configured with a compression screw guide 58 for placement of a compression screw 60 through the tibia TI into the talus T across the tibiotalar joint TJ outside of the nail 12. When tightened, the compression screw 60 provides compression to the then fused tibiotalar joint TJ in a manner described in greater detail below. The compression screw guide 58 may, for example, comprise a channel, an alignment aperture or a sleeve.
The tibiotalar implant system 10 described above is useful in a method of fusing a tibiotalar joint TJ with an intramedullary nail 12 while leaving the talocalcaneal of subtalar joint intact. Incisions should be thoughtfully planned, and the soft tissues should be handled with care. Joint preparation should be thorough and meticulous, and broad, congruent, bleeding cancellous surfaces should be created, ideally so that apposition of those surfaces can be obtained. All articular cartilage should be removed, as should the subchondral bone. Fixation of the arthrodesis site should be rigid. Particular attention should be paid to the position and alignment of the arthrodesis.
The following briefly describes the surgical approach and nail placement.
This disclosure may be considered to relate to the following items:
Terms of approximation, such as the terms about, substantially, approximately, etc., as used herein, refers to ±10% of the stated numerical value. Use of the terms parallel or perpendicular are meant to mean approximately meeting this condition, unless otherwise specified.
It is to be fully understood that certain aspects, characteristics, and features, of the method of fusing a tibiotalar joint with an intramedullary nail while leaving the talocalcaneal joint intact and the resulting fused tibiotalar joint 10, which are, for clarity, illustratively described and presented in the context or format of a plurality of separate embodiments, may also be illustratively described and presented in any suitable combination or sub-combination in the context or format of a single embodiment. Conversely, various aspects, characteristics, and features, of the method of fusing a tibiotalar joint with an intramedullary nail while leaving the talocalcaneal joint intact and the resulting fused tibiotalar joint 10 which are illustratively described and presented in combination or sub-combination in the context or format of a single embodiment may also be illustratively described and presented in the context or format of a plurality of separate embodiments.
Although method of fusing a tibiotalar joint with an intramedullary nail while leaving the talocalcaneal joint intact and the resulting fused tibiotalar joint 10 of this disclosure have been illustratively described and presented by way of specific exemplary embodiments, and examples thereof, it is evident that many alternatives, modifications, or/and variations, thereof, will be apparent to those skilled in the art. Accordingly, it is intended that all such alternatives, modifications, or/and variations, fall within the spirit of, and are encompassed by, the broad scope of the appended claims.
The foregoing has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the embodiments to the precise form disclosed. Obvious modifications and variations are possible in light of the above teachings. For example, as illustrated in
This application claims priority to U.S. Provisional Patent Application Ser. No. 63/045,374 filed on Jun. 29, 2020, which is hereby incorporated by reference in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2021/039379 | 6/28/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63045374 | Jun 2020 | US |
