METATARSOPHALANGEAL (MTP) FUSION PLATE DEVICE WITH GRAFT HOLDING AND GRAFT HARVESTING INSTRUMENT

Abstract

A graft-harvesting instrument and MTP fusion device are disclosed to allow for easy and safe removal of a section of the calcaneus to be used as autograft in the fusion of the MTP joint. The graft-harvesting instrument allows a surgeon to place a barrier between the saw and the vital anatomy on the medial side of the calcaneus. The MTP fusion device allows for the exact placement of the autograft into the MTP joint. The graft-harvesting instrument allows for a very consistent piece of autograft to be harvested. The graft-retaining sleeve component of the MTP fusion device positions that autograft in place for optimum fusion of the MTP joint.

Claims

1. A graft harvesting tool comprising: a pair of handles moveable from a first position to a second position; a first component and a second component positioned at each end of the pair of handles; and a saw guide disposed over a portion of the first and second components, wherein the saw guide provides for accurate cutting of a bone when the pair of handles is provided in the first position.

2. The graft harvesting tool as recited in claim 1, wherein the first position is an open position and the second position is a closed position.

3. The graft harvesting tool as recited in claim 1, wherein the saw guide is positionable on the first and second components to define a cutting area.

4. The graft harvesting tool as recited in claim 3, wherein the saw guide is held in position by at least one of a pin or a wire.

5. The graft harvesting tool as recited in claim 1, wherein the first and second components are L-shaped.

6. The graft harvesting tool as recited in claim 4, wherein the wire is a K-wire.

7. The graft harvesting tool as recited in claim 3, wherein a graft is removed from the cutting area when the pair of handles are in the closed position.

8. The graft harvesting tool as recited in claim 1, wherein the pair of handles can be pivoted upwards away from the saw guide during cutting.

9. A metatarsophalangeal (MTP) fusion device comprising: a plate for use in a MTP fusion procedure, wherein the plate is comprised of a first end, a second end, an inner surface, an outer surface and a compression slot; and a retaining sleeve component comprised of an osteo-integrative mesh.

10. The metatarsophalangeal (MTP) fusion device as recited in claim 9, wherein the osteo-integrative mesh is comprised of a geometric design pattern or a random design pattern.

11. The metatarsophalangeal (MTP) fusion device as recited in claim 9, wherein the compression slot is positioned over a graft to compress the graft into position.

12. The metatarsophalangeal (MTP) fusion device as recited in claim 9, wherein the plate has an angle on the inner surface in a dorsal direction of between 0° and 10°.

13. The metatarsophalangeal (MTP) fusion device as recited in claim 9, wherein the plate has an angle on the inner surface in a valgus direction of between 0° and 20° degrees.

14. The metatarsophalangeal (MTP) fusion device as recited in claim 9, wherein each of the first and second ends of the plate comprises a pair of ears extending generally outwardly from a pair of sides of the plate.

15. The metatarsophalangeal (MTP) fusion device as recited in claim 9, wherein the plate comprises a plurality of through holes to receive one or more fasteners.

16. The metatarsophalangeal (MTP) fusion device as recited in claim 9, wherein the osteo-integrative mesh is positioned in a central portion of the plate.

17. The metatarsophalangeal (MTP) fusion device as recited in claim 9, wherein the compression slot comprises an edge having an incline that slopes downward toward a transverse medial axis of the plate.

18. The metatarsophalangeal (MTP) fusion device as recited in claim 9, wherein the retaining sleeve component holds the plate in a desired position.

19. A method of making a metatarsophalangeal (MTP) fusion device comprising the steps of: collecting a plurality of measurements for use in create a MTP fusion device; loading the plurality of measurements into a system for additively printing the MTP fusion device; printing the MTP fusion device; confirming the plurality of measurements of the MTP fusion device; and installing the MTP fusion device during a surgical procedure.

20. The method of making a metatarsophalangeal (MTP) fusion device as recited in claim 19, wherein the MTP fusion device comprises a first end, a second end, a pair of ears disposed at each of the first and second ends, a retaining sleeve component and an osteo-integrative mesh comprised of a geometric design pattern or a random design pattern.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The description refers to provided drawings in which similar reference characters refer to similar parts throughout the different views, and in which:

[0022] FIG. 1 illustrates a side perspective view of one potential embodiment of the graft-harvesting instrument of the present invention disclosing placement over the calcaneus in accordance with the disclosed architecture;

[0023] FIG. 2 illustrates a front perspective view of one potential embodiment of the graft-harvesting instrument of the present invention with the saw cut guide component attached in accordance with the disclosed architecture;

[0024] FIG. 3 illustrates a side perspective view of one potential embodiment of the graft-harvesting instrument of the present invention with the pair of handles pivoted out of the way for saw insertion in accordance with the disclosed architecture;

[0025] FIG. 4 illustrates a bottom perspective view of one potential embodiment of the MTP plate of the present invention and having a retaining sleeve component in accordance with the disclosed architecture;

[0026] FIG. 5 illustrates a side perspective view of one potential embodiment of the MTP plate of the present invention and having a retaining sleeve component with the mesh removed in accordance with the disclosed architecture;

[0027] FIG. 6 illustrates a side perspective view of one potential embodiment of the MTP plate of the present invention with the graft in place within the retaining sleeve component in accordance with the disclosed architecture;

[0028] FIG. 7 illustrates a top perspective view of one potential embodiment of the MTP plate in use and secured across an MTP joint in accordance with the disclosed architecture; and

[0029] FIG. 8 illustrates a block diagram of one potential method of manufacturing the MTP plate of the present invention in accordance with the disclosed architecture.

DETAILED DESCRIPTION OF THE INVENTION

[0030] The innovation is now described with reference to the drawings, wherein like reference numerals are used to refer to like elements throughout. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding thereof. It may be evident, however, that the innovation can be practiced without these specific details. In other instances, well-known structures and devices are shown in block diagram form in order to facilitate a description thereof. Various embodiments are discussed hereinafter. It should be noted that the figures are described only to facilitate the description of the embodiments. They are not intended as an exhaustive description of the invention, and do not limit the scope of the invention. Additionally, an illustrated embodiment need not have all the aspects or advantages shown. Thus, in other embodiments, any of the features described herein from different embodiments may be combined.

[0031] The present invention discloses a graft-harvesting instrument and MTP fusion device to create a more secure fusion environment, increased capacity for bone ingrowth, and lengthening of the toe as compared to traditional or conventional methods. The graft-harvesting instrument allows for easy and safe removal of a section of the calcaneus to be used as autograft. The instrument allows a surgeon to place a barrier between the saw or cutting implement and the vital anatomy on the medial side of the calcaneus. The MTP fusion device allows for the exact placement of the autograft into the MTP joint. The graft-harvesting instrument allows for a very consistent piece of autograft to be harvested. The graft-retaining sleeve component of the MTP fusion device positions that autograft in place for optimum fusion of the MTP joint.

[0032] Further, the graft-harvesting instrument has a pair of handles and a pair of L-shaped components that are positioned over the calcaneus to act as a barrier between the saw or cutting tool and the vital anatomy on the medial side of the calcaneus. The MTP fusion device includes an MTP plate with an osteo-integrative mesh retaining sleeve component, sized to retain the autograft bone section harvested from the calcaneus via the graft-harvesting instrument.

[0033] Referring initially to the drawings, FIGS. 1-3 illustrate the graft-harvesting instrument 100 which allows for the easy and safe removal of a section of the calcaneus to be used as autograft. The graft-harvesting instrument 100 can be any suitable size, shape and configuration as is known in the art without affecting the overall concept of the invention. One of ordinary skill in the art will appreciate that the shape and size of the graft-harvesting instrument 100 as shown in FIGS. 1-3 is for illustrative purposes only, and many other shapes and sizes of the graft-harvesting instrument 100 are well within the scope of the present disclosure. Although dimensions of the graft-harvesting instrument 100 (i.e., length, width, and height) are important design parameters for good performance, the graft harvesting instrument 100 may be any shape or size that ensures optimal performance during use, and may even be customized to fit the exact specifications/measurements of the patient's foot.

[0034] Additionally, the graft-harvesting instrument 100 has a pair of handles 102 operable to be squeezed together and spread apart by a user. The graft harvesting instrument 100 also has a pair of L-shaped components 104 which are removably-secured to the pair of handles 102, and extend outwardly from the end of the handles. Typically, the pair of L-shaped components 104 are removably-secured to the pair of handles 102 via a push button connector 106 or any other securing means as is suitable. The pair of handles 102 act to pivot or move the pair of L-shaped components 104 into an open and closed position. Specifically, spreading apart the pair of handles 102 acts to open the pair of L-shaped components 104 or spread them apart so that a surgeon may position the pair of L-shaped components 104 over the calcaneus to create a barrier that protects the nerves and vessels on the medial side of the calcaneus. The spread-apart pair of L-shaped components 104 forms a barrier which allows the surgeon to use a saw or other tool to cut through the calcaneus without fear of damaging vital anatomy on the medial side.

[0035] Further, the graft-harvesting instrument 100 has a saw cut guide 108 that is slid onto the pair of L-shaped components 104 when the components 104 are in an open position. Specifically, the saw cut guide 108 is secured to the pair of L-shaped components 104 via a T-slot (not shown) or other suitable connector. Once the saw cut guide 108 is secured to the pair of L-shaped components 104, it is fixated with pins or K-wires or any other suitable fixating means as is known in the art. The saw guide 108 can be positioned in any suitable location along the L-shaped components depending on the location that the cutting is to take place.

[0036] As shown in FIG. 3, the pair of handles 102 of the graft-harvesting instrument 100 can then be pivoted out of the way to allow for easy saw insertion. This allows the surgeon access to the saw cut guide 108. Once the surgeon is done cutting, the pair of handles 102 are then pivoted back down and squeezed together, which pushes the pair of L-shaped components 104 together or in a closed position. Once the pair of L-shaped components 104 is in a closed position, the surgeon can easily pull or remove the autograft out of the calcaneus in one piece with one fluid motion. Thus, the pair of L-shaped components 104 needs to be in an open or first position for cutting, and then in a second or closed position to extract the autograft once the cutting is complete.

[0037] In a preferred embodiment, the graft-harvesting instrument 100 is machined of medical-grade titanium. Further, the graft-harvesting instrument 100 is manufactured with medical-grade titanium but can be manufactured with any other suitable metal as is known in the art, as long as the metal is medical grade.

[0038] Once the graft harvesting instrument 100 harvests a piece of autograft, the MTP fusion device 110 positions that autograft in place for optimum fusion of the MTP joint. Referring initially to the drawings, FIGS. 4-7 illustrate the MTP fusion device 110 which is designed to hold the autograft bone in place to promote lengthening of the toe and fusion of the joint. The MTP fusion device 110 can be any suitable size, shape and configuration as is known in the art without affecting the overall concept of the invention. One of ordinary skill in the art will appreciate that the shape and size of the MTP fusion device 110 as shown in FIGS. 4-7 is for illustrative purposes only, and many other shapes and sizes of the MTP fusion device 110 are well within the scope of the present disclosure. Although dimensions of the MTP fusion device 110 (i.e., length, width and height) are important design parameters for good performance, the MTP fusion device 110 may be any shape or size that ensures optimal performance during use, and may even be customized to fit the exact specifications or measurements of the patient's first metatarsal.

[0039] The MTP fusion device 110 is an intramedullary fixation device which includes a plate 112 which is capable of fixation of bone at the first metatarsophalangeal joint. Further, the plate 112 extends along a length, and has a first end 114 and a second end 116. The first end 114 has a terminal area 118 with a compression slot 120 and opposing first and second ears 122, the first and second ears 122 each have a threaded through hole for receiving a fastener. Further, the second end 116 also includes a terminal area 124 with a screw hole 126 and opposing first and second ears 128, the first and second ears 128 each having a threaded through hole. Wherein, the opposing ears 122 on the first end 114 and the opposing ears 128 on the second end 116 are offset to each other relative to the length of the plate 112. The first and second ears 122 and 128 and the screw hole 126 all have internal threads to accept screws or other fasteners as are known in the art to create locking holes to secure the plate 112 to the bone. Further, the compression slot 120 includes an edge that has an incline that slopes downward toward the transverse medial axis of the plate 112, when a screw is secured within the compression slot 120, the osteotomy is compressed together.

[0040] Additionally, the plate 112 has an inner surface 130 which includes a first axis and which forms an angle in the dorsal direction of between 0°-10°, and which forms an angle in the valgus direction of between 0°-20° degrees. Further, the plate 112 has a second axis as well as a first axis, and the first and second axis being at an angle from about 0° to about 10° from each other in the dorsal direction and in the valgus direction from about 0° to about 20° from each other. Further, the plate 112 has a transverse central axis about which the plate 112 displays at least substantial mirror symmetry.

[0041] Moreover, the plate 112 of the MTP fusion device 110 includes a retaining sleeve component 132 designed to hold the autograft bone 600 in place to promote lengthening of the toe and fusion of the joint. Specifically, the retaining sleeve component 132 is sized to retain the autograft bone section 600 harvested from the calcaneus via the graft harvesting instrument 100. Typically, the autograft 600 protrudes from either side of the retaining sleeve component 132 to assure contact with bone. Thus, any compression on the joint will be directly placed on the graft 600. Having the graft 600 under compressive load is intended to promote the bone to grow faster and stronger as well as to hold the graft in position.

[0042] Further, the retaining sleeve component 132 of the MTP fusion device 110 has an osteo-integrative mesh 134. The osteo-integrative mesh 134 which is positioned generally centrally of the plate, provides for an increased capacity for bone ingrowth and a more secure fusion. The osteo-integrative mesh 134 can be shaped as a geometric design comprising shapes such as crosses, squares, and/or triangles in every direction, or shaped more of an organic design where the indices are random and protrude in all directions, at different angles and thicknesses. This osteo-integrative mesh 134 promotes bone growth within and around the surgical site, creating a more secure fusion of the MTP joint.

[0043] In a preferred embodiment, the MTP fusion device 110 is manufactured using additive manufacturing (AM) techniques and grown as one part. Specifically, the MTP fusion device 110 is additively printed, and able to be manufactured in a variety of sizes as well as to be customizable to fit the exact specifications or measurements of the patient's foot. Further, the MTP fusion device 110 is additively printed with titanium, but can be additively printed with any other suitable metal as is known in the art, as long as the metal is medical grade and able to be additively printed.

[0044] In operation, as shown in FIG. 7, a surgeon spreads apart the pair of handles 102 of the graft-harvesting instrument 100 to open or spread apart the pair of L-shaped components 104 to create a barrier that protects the nerves and vessels on the medial side of the calcaneus. Specifically, the surgeon positions the pair of L-shaped components 104 over the calcaneus to create a barrier, which allows the surgeon to use a saw or other tool to cut through the calcaneus without fear of damaging vital anatomy on the medial side.

[0045] Once the graft-harvesting instrument 100 is in place, a saw cut guide 108 is then slid onto the pair of L-shaped components 104 when the components 104 are in an open position via a T-slot (not shown). The saw cut guide 108 is then fixated with pins or K-wires. The pair of handles 102 of the graft harvesting instrument 100 is then pivoted out of the way to allow for easy saw insertion. This allows the surgeon access to the saw cut guide 108. Once the surgeon is done cutting, the pair of handles 102 is then pivoted back down and squeezed together, which pushes the pair of L-shaped components 104 together or in a closed position. Once the pair of L-shaped components 104 is in a closed position, the surgeon can easily pull the autograft out of the calcaneus in one piece with one fluid motion.

[0046] Once the graft-harvesting instrument 100 harvests a piece of autograft, the surgeon positions the piece of autograft within the retaining sleeve component 132 of the MTP fusion device 110 for optimum fusion of the MTP joint. The MTP fusion device 110 is then applied to the first metatarsal 700 of the foot. The goal of surgery is to make the great toe joint solidly aligned and immobile. This eliminates much of the pain associated with the arthritic joint, since there will now be no motion through the arthritic joint. Specifically, an incision is made on top of the big toe. Any remaining cartilage is cleared away to allow the two bones to heal or fuse together. To fuse the great toe joint, any remnant cartilage on the arthritic joint surface is also removed, and the surgeon uses a combination of instruments and tools to shape each bone for a perfect fit, which prepares the underlying bone for fusion.

[0047] Then, the plate 112 of the MTP fusion device 110 is positioned over the first metatarsal 700. The joint is then positioned in a manner that maximizes walking ability and maintains acceptable clinical alignment. This is traditionally done with the toe positioned so that it just gently touches the ground in a weight-bearing position. Once the joint is correctly positioned, a screw or other fastener (not shown) is driven through the screw hole 126 on the second end 116 into the phalanx 702, and then a screw or other fastener (not shown) is driven through the compression slot 120 on the first end 114 into the metatarsal 700 to compress the osteotomy together. Once the desired compression is achieved, screws are driven through the opposing first and second ears 122 and 128 to further secure the MTP fusion device 110 in position between the first metatarsal 700 and the distal phalanx 702. Typically, the autograft protrudes from either side of the retaining sleeve component 132 to assure contact with bone. Thus, any compression on the joint will be directly placed on the graft. Having the graft under compressive load will promote the bone to grow faster and stronger.

[0048] FIG. 8 illustrates a block diagram of one potential method of manufacturing the MTP plate of the present invention in accordance with the disclosed architecture. The method begins at step 500 with obtaining measurements for the fusion device or plate. The measurements are uploaded at step 510 to a surgical implant printing device such as, but not limited to, a 3-D metal printing device. Then, at step 520, the plate or fusion device is printed, and the measurements of the plate are confirmed, with the initial measurements entered into the system at step 530. Once the set of measurements is confirmed, then at step 540 the plate is inserted into position during a surgical procedure.

[0049] Certain terms are used throughout the following description and claims to refer to particular features or components. As one skilled in the art will appreciate, different persons may refer to the same feature or component by different names. This document does not intend to distinguish between components or features that differ in name but not structure or function. Also, notwithstanding the forgoing, the present invention and its various components can be of any suitable size and configuration as is known in the art without affecting the overall concept of the invention, provided that they accomplish the above-stated objectives. One of ordinary skill in the art will appreciate that the size, configuration and material of the invention and its various components as shown in the FIGS. are for illustrative purposes only, and that many other sizes and shapes of the invention and its various components are well within the scope of the present disclosure. Although the dimensions of the invention and its components are important design parameters for user convenience, the invention and its components may be of any size, shape and/or configuration that ensures optimal performance during use and/or that suits the user's needs and/or preferences.

[0050] Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. While the embodiments described above refer to particular features, the scope of this invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations as fall within the scope of the claims, together with all equivalents thereof.

[0051] What has been described above includes examples of the claimed subject matter. It is, of course, not possible to describe every conceivable combination of components or methodologies for purposes of describing the claimed subject matter, but one of ordinary skill in the art may recognize that many further combinations and permutations of the claimed subject matter are possible. Accordingly, the claimed subject matter is intended to embrace all such alterations, modifications and variations that fall within the spirit and scope of the appended claims. Furthermore, to the extent that the term “includes” is used in either the detailed description or the claims, such term is intended to be inclusive in a manner similar to the term “comprising” as “comprising” is interpreted when employed as a transitional word in a claim.