The present disclosure relates generally to prosthetic devices and, more specifically, to prosthetic implants for use in a metatarso-phalangeal joint of a patient.
Repair of joints often involves the use of fixation devices to secure parts of the bony anatomy together during the healing process. There are many forms of bone fixation devices, including intramedullary devices, pins, screws, plates, and staples. In some cases, it may be necessary to fuse two bones together permanently. One such procedure is a metatarso-phalangeal joint (MPJ) fusion procedure.
Various methods and implants have been developed for use in an MPJ fusion procedure. Methods and implants are described in U.S. Pat. Nos. 8,920,476; 8,920,453; and 9,017,329. This listing is not intended as a representation that a complete search of all relevant prior art has been conducted, or that no better references than those listed exist.
According to one aspect, a prosthetic component for use in a metatarso-phalangeal joint fusion procedure for a patient is disclosed. The prosthetic component comprises a single monolithic body including a first end that is sized to be positioned in a surgically-prepared bore defined in a proximal phalange of the patient's foot and a second end sized to be positioned in a surgically-prepared bore defined in a distal end of a metatarsal bone of the patient's foot. The first end, which may be a distal end, is laterally offset from the second end when the single monolithic body is viewed in a first anatomical plane, such as, for example, the transverse plane of the patient's body.
In some embodiments, the second end of the single monolithic body may include a plurality of threads configured to be threaded into the surgically-prepared bore of the distal end of the metatarsal bone of the patient's foot.
In some embodiments, a first generally central axis may extend through the first end of the single monolithic body, a second generally central axis may extend through the second end of the single monolithic body, and an angle may be defined between the first generally central axis and the second generally central axis when the single monolithic body is viewed in the first plane. The angle may have a magnitude greater than 0 degrees. It should be appreciated that the angle may correspond to a desired valgus angle of the phalange relative to the metatarsal bone.
In some embodiments, the magnitude of the angle may be less than or equal to 20 degrees. In some embodiments, the magnitude may be equal to one of approximately 5 degrees, 10 degrees, and 20 degrees.
Additionally, in some embodiments, a second angle may be defined between the first generally central axis and the second generally central axis when the single monolithic body is viewed in a second anatomical plane extending orthogonal to the first plane. The second plane may be a sagittal plane of the patient's body, and the second angle may correspond to a desired dorsiflexion angle of the phalange relative to the metatarsal bone. The second angle may have a magnitude greater than 0 degrees.
In some embodiments, the magnitude of the second angle may be less than or equal to 35 degrees. In some embodiments, the magnitude of the second angle may be equal to approximately 20 degrees. As described above, in some embodiments, the first plane may be a transverse plane, and the second plane may be a sagittal plane.
In some embodiments, the single monolithic body may include a first body section that includes the first end and extends along the first generally central axis, a second body section that includes the second end and extends along the second generally central axis, and a central body section extending along a third generally central axis from a first section end connected to the first body section to a second section end connected to the second body section. A third angle may be defined between the first generally central axis and the third generally central axis when the single monolithic body is viewed in the first plane. The third angle may have a magnitude greater than 0 degrees.
In some embodiments, a spline may extend along the first end of the single monolithic body. The spline may be configured to engage bone surrounding the surgically-prepared bore defined in the proximal phalange of the patient's foot. In some embodiments, the spline may be one of a plurality of splines arranged around an outer circumference of the first end of the single monolithic body.
Additionally, in some embodiments, the single monolithic body may have a passageway defined therein that is sized to receive a fastener. In some embodiments, the passageway may be threaded at least one end.
In some embodiments, a surgical kit may comprise the prosthetic component described herein and further comprise a surgical tool including an offset corresponding to the offset of the first end relative to the second end and Kirschner wire.
According to another aspect, a prosthetic component for use in a metatarso-phalangeal joint fusion procedure for a patient comprises a single monolithic body. The body includes a distal body section that is sized to be positioned in a surgically-prepared bore defined in a proximal phalange of the patient's foot, and a proximal body section that is configured to be threaded into a surgically-prepared bore defined in a distal end of a metatarsal bone of the patient's foot. When the single monolithic body is viewed in a first plane, an angle is defined between a first generally central axis extending along the distal body section and a second generally central axis extending along the proximal body section. The angle has a magnitude greater than 0 degrees. Additionally, the distal body section is laterally offset from the proximal body section when the single monolithic body is viewed in the first plane.
In some embodiments, a second angle may be defined between the first generally central axis and the second generally central axis when the single monolithic body is viewed in a second plane extending orthogonal to the first plane. The second angle may have a magnitude greater than 0 degrees.
In some embodiments, a generally central spline may extend along the distal body section, and the spline may be configured to engage bone surrounding the surgically-prepared bore defined in the proximal phalange of the patient's foot. In some embodiments, the spline may be one of a plurality of splines arranged around an outer circumference of the distal body section.
According to another aspect, a method of performing a procedure on a patient is disclosed. The method comprises reaming a proximal phalange of the patient's foot, reaming a distal end of a metatarsal bone of the patient's foot, selecting a prosthetic component including a first end and a plurality of threads on a second end opposite the first end, threading the second end of the prosthetic component into the distal end of a metatarsal bone of the patient's foot, inserting a fastener through a passageway defined in the prosthetic component, and engaging the first end of the prosthetic component with the proximal phalange of the patient's foot after inserting the fastener. In some embodiments, the fastener may include at least one of a Kirschner wire and a screw.
In some embodiments, the method may also comprise driving a Kirschner wire into the proximal phalange after engaging the first end of the prosthetic component with the proximal phalange of the patient's foot. In some embodiments, advancing a screw into the surgically-prepared opening may include advancing the screw along the Kirschner wire. In some embodiments, the method may further comprise angling the proximal phalange relative to the distal end of the metatarsal bone before engaging the first end of the prosthetic component with the proximal phalange.
In some embodiments, engaging the first end of the prosthetic component with the proximal phalange of the patient's foot may include engaging at least one spline formed on the first end of the prosthetic component with the proximal phalange of the patient's foot.
According to another aspect, a method of performing a procedure on a patient comprises reaming a proximal phalange of the patient's foot, reaming a distal end of a metatarsal bone of the patient's foot, selecting a prosthetic component a first end and a plurality of threads on a second end opposite the first end, threading the second end of the prosthetic component into the distal end of a metatarsal bone of the patient's foot, inserting a Kirschner wire through a passageway defined in the prosthetic component, engaging the first end of the prosthetic component with the proximal phalange of the patient's foot after inserting the Kirschner wire, driving the Kirschner wire into the proximal phalange to define a surgically-prepared opening in the proximal phalange, removing the Kirschner wire after driving the Kirschner wire into the proximal phalange, and advancing a screw into the surgically-prepared opening.
In other embodiments, advancing the screw into the surgically-prepared opening may include advancing the screw into the surgically-prepared opening after removing the Kirschner wire.
In some embodiments, preparing the proximal phalange of the patient's foot to receive a prosthetic component may include resecting the proximal phalange with a convex cup reamer having a first diameter, and preparing the distal end of the metatarsal bone of the patient's foot to receive the prosthetic component may include resecting the distal end with a concave cup reamer having a second diameter that is different from the first diameter. In some embodiments, the second diameter is less than the first diameter.
In some embodiments, engaging the first end of the prosthetic component with the proximal phalange of the patient's foot may include engaging at least one spline formed on the first end of the prosthetic component with the proximal phalange of the patient's foot.
According to another aspect, a method of removing a prosthetic component from a patient is disclosed. The method includes cutting the component to separate a distal body section positioned in a proximal phalange of the patient's foot from a proximal body section position in a distal end of a metatarsal bone of the patient's foot, inserting a threaded shaft into the distal body section, and pulling the threaded shaft away from the proximal phalange to withdraw the distal body section from the proximal phalange.
In some embodiments, the method may also include inserting a threaded shaft into the proximal body section to withdraw the proximal body section from the distal end of the patient's metatarsal bone.
The detailed description particularly refers to the following figures, in which:
While the concepts of the present disclosure are susceptible to various modifications and alternative forms, specific exemplary embodiments thereof have been shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that there is no intent to limit the concepts of the present disclosure to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.
Referring now to
In the illustrative embodiment, the elongated body 12 is formed from an component-grade polymeric material such as, for example, polyether ether ketone (PEEK) that has been injection-molded into a single piece in the shape shown in
The elongated body 12 may include a number of connected body sections between its ends 14, 16. For example, as shown in
In the illustrative embodiment, the proximal body section 22 includes a tip 32 at the proximal end 14 and an outer surface 34 that extends between the tip 32 and the proximal joint 24. A plurality of threads 36 are arranged on the outer surface 34 such that the proximal body section 22 may be threaded into the distal end of the metatarsal bone 18. The threads 36 are illustratively self-tapping. In some embodiments, a threaded aperture may be defined in the proximal body section 22, which may be used with a removal tool to assist the surgeon in removing the proximal body section 22 from the patient's bone in a revision or like surgical procedure.
The distal body section 26 includes another tip 42 at the distal end 16 and a substantially cylindrical outer surface 44 that extends between the tip 42 and the distal joint 28. In the illustrative embodiment, the distal body section 26 is grit-blasted. In other embodiments, the body section 26 may be spray-coated with titanium plasma.
As shown in
Referring now to
As shown in
Referring now to
As shown in
Referring now to
The proximal body section 22 of the component 10 is positioned in a surgically-prepared bore 90 extending inwardly from the convex surface 82 of the metatarsal bone 18. Similarly, the distal body section 26 of the component 10 is positioned in a surgically prepared bore 92 extending inwardly from the concave surface 86 of the phalange 20. As shown in
Referring now to
Prior to beginning the method 200, the surgeon or other medical staff may obtain one or more sterile surgical kits including the prosthetic component 10 and a number of surgical instruments, including, for example, Kirschner wire 76 and one or more bone cannulated screws 78. The kits may include one or more prosthetic components 10 of different sizes to be used with bones of different sizes. The kits may also include prosthetic components customized for use with a left foot or a right foot of a patient. The surgical instruments in the kit may include one or more trial component 100 (see
The method 200 may begin with the surgeon opening the patient's tissue surrounding the metatarso-phalangeal joint to prepare the proximal phalange 20 and the metatarsal bone 18 in block 202. To prepare the proximal phalange 20, the surgeon may utilize a convex cup reamer 126 (see
As shown in
The corresponding concave cup reamer 128 is shown in
It should be appreciated that the cutting diameter of the concave reamer 128 is less than the cutting diameter of the convex reamer 126. This “mismatch” permits the shape and size of the prosthetic component 10 to define the alignment of the joint rather than permitting the center of rotation of the reamers to define the alignment. In the illustrative embodiment, the mismatch is equal to 2 millimeters, as measured on the diameter of the reamed surfaces.
After the reaming is complete, the method 200 may then advance to block 204 in which the surgeon may select a trial component 100 corresponding to the size and shape of a prosthetic component 10. The surgeon may then insert the trial component 100 into the bores 90, 92 defined in the bones 18, 20, as shown in
In block 206, the surgeon may attach the selected prosthetic component 10 to a driver 102, as shown in
The surgeon may align the proximal end 14 of the component 10 with the bore 90 defined in the metatarsal bone 18 and then advance the proximal end 14 into the bore 90. When the threads 36 engage the bone surrounding the bore 90, the surgeon may rotate the driver 102 about its axis 110 to thread the proximal body section 22 into the bore 90. As shown in FIG. 12, when properly positioned in the bore 90, the proximal body section 22 is fully received in the bore 90. In the illustrative embodiment, the tilt or angle of the central body section 30 is accommodated in the bore 90 by an annular chamfer 124 defined at the end of the bore 90. The method 200 may then advance to block 208.
In block 208, the surgeon advances a Kirschner wire 76 through the prosthetic component 10 and the metatarsal bone 18, as shown in
As shown in block 210 of the method of
When the phalange 20 is seated on the distal body section 26 of the component, the surgeon may advance to block 212. In block 212, the surgeon drives the Kirschner wire 76 into the phalange 20. To do so, the surgeon may drive the pointed tip 94 to advance the wire 76 distally through the passageway 70 of the component 10 and into contact with the phalange 20. The surgeon may continue tapping the wire 76 along this trajectory until positioned as shown in
As shown in block 214 of the method of
Returning to block 214, if the surgeon decides not to use a bone screw, the method advances to block 218. In block 218, the surgeon clips the ends of the Kirschner wire 76 close to the bone. The wire 76 is then left with the component 10 embedded in the patient's bones. The surgeon may then close the wound.
Referring now to
The method 300 may then advance to block 304. In block 304, surgeon may insert a removal tool having a threaded distal end into the distal body section 26 of the component 10. With the removal tool engaged with the distal body section 26, the surgeon may, in block 306, pull the distal body section 26 in a proximal direction to withdraw the section 26 from the proximal phalange 20.
To remove the proximal body section 22 from the metatarsal bone 18 in block 308, the surgeon may thread the removal tool into the proximal body section 22. The surgeon may continue rotating the removal tool after it is bottomed on the body section to cause the proximal body section 22 to unscrew from the metatarsal bone 18. The surgeon may then proceed with further steps to complete the surgical procedure.
It should be appreciated that the concept of a single, monolithic prosthetic component configured for insertion into the bones of a joint may also be used in a hand or foot proximal interphalangeal joint fusion procedure.
While the disclosure has been illustrated and described in detail in the drawings and foregoing description, such an illustration and description is to be considered as exemplary and not restrictive in character, it being understood that only illustrative embodiments have been shown and described and that all changes and modifications that come within the spirit of the disclosure are desired to be protected.
There are a plurality of advantages of the present disclosure arising from the various features of the method, apparatus, and system described herein. It will be noted that alternative embodiments of the method, apparatus, and system of the present disclosure may not include all of the features described yet still benefit from at least some of the advantages of such features. Those of ordinary skill in the art may readily devise their own implementations of the method, apparatus, and system that incorporate one or more of the features of the present invention and fall within the spirit and scope of the present disclosure as defined by the appended claims.
This application claims priority to U.S. Patent App. Ser. No. 62/364,816, which was filed on Jul. 20, 2016 and is incorporated herein by reference.
Number | Date | Country | |
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62364816 | Jul 2016 | US |