Compression distractor for angling and realigning bone segments
The compression distractor device addresses the challenge of inefficient bone realignment in surgical procedures by using angled pin-receiving holes and an actuator to precisely realign and fix misaligned bones, enhancing surgical accuracy and efficacy.
Patent Information
- Application Number
- JP2021500819
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2019-02-13
- Filing Date
- 2019-07-11
- Publication Date
- 2025-12-16
- Estimated Expiration
- 2039-07-11
AI Technical Summary
Existing surgical procedures for correcting bone deformities such as hallux valgus lack efficient and reproducible instruments for accurately realigning bones, particularly in the foot, leading to functional disabilities and pain.
A compression distractor device with angled pin-receiving holes and an actuator mechanism is used to move bone portions relative to each other, allowing for precise realignment and fixation of misaligned bones, such as the metatarsal and cuneiform bones, by applying compressive or distractive forces.
The compression distractor enables accurate and reproducible realignment of bones, providing an enlarged separation gap for cleaning and preparing the interbone space, facilitating efficient bone fixation and reducing surgical complications.
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Abstract
Description
[Technical Field]
[0001] Related Applications This application claims the benefit of U.S. Provisional Application No. 62 / 696,565, filed July 11, 2018, and U.S. Provisional Application No. 62 / 805,228, filed February 13, 2019, the entire contents of each of which are incorporated herein by reference.
[0002] The present disclosure relates generally to devices and techniques for repositioning bones, and more particularly to devices and techniques for repositioning bones of the foot. [Background technology]
[0003] Bones in the human body, such as those of the foot, can be anatomically misaligned. For example, one common type of bone deformity is hallux valgus, a progressive foot deformity that affects the first metatarsophalangeal joint and often results in significant functional disability and foot pain. The metatarsophalangeal joint is laterally misaligned, causing the first metatarsal to abduct while the phalanges adduct. This often leads to the development of soft tissue and a bony prominence on the medial side of the foot, called hallux valgus.
[0004] Surgical intervention may be used to correct hallux valgus deformity. A variety of different surgical procedures exist to correct hallux valgus deformity and may involve removing the abnormal bony enlargement of the first metatarsal and / or attempting to realign the first metatarsal relative to the adjacent metatarsals. Surgical instruments that can promote efficient, accurate, and reproducible clinical results are useful to practitioners performing bone realignment techniques. Summary of the Invention
[0005] Generally, the present disclosure is directed to devices and techniques that can be used during surgical bone realignment procedures. In some examples, a compression distractor device is described that can be used during a surgical procedure, such as a surgical procedure for correcting a hallux valgus deformity. The compression distractor can include first and second engagement arms that define first and second pin-receiving holes, respectively. The first and second pin-receiving holes can be angled relative to one another. The compression distractor can also include an actuator operably coupled to the first and second engagement arms. For example, the first and second engagement arms of the compression distractor can be movably connected to one another via a threaded rod. Rotation of an actuator knob attached to the threaded rod can move the first and second engagement arms relative to one another.
[0006] A compression distractor can be used during a surgical procedure in which one or more other surgical instruments are also used. For example, a compression distractor can be used during a procedure in which an osteogenic guide is also deployed to form bones that are subsequently distracted and / or compressed together using the compression distractor. The osteogenic guide can be pinned to two different bone portions, which can be two different bones separated by a joint, or two portions of the same bone (e.g., separated by a fracture or dislocation). In either case, one end of the osteogenic guide can be pinned to one bone portion and the other end of the osteogenic guide can be pinned to the other bone portion. The osteogenic guide can be pinned to two bone portions using a pair of pins extending parallel to each other through a pair of fixation openings on the osteogenic guide, optionally with one or more additional pins that can extend through one or more additional fixation openings on the osteogenic guide, which may be inclined or angled at a non-zero degree angle relative to the parallel pins. In some configurations, the osteogenic guide defines one or more slots into which an osteogenic instrument (e.g., a cutting instrument) is inserted to form the opposing end faces of the two bones.
[0007] After forming two bone segments using the osteogenic guide, the clinician can remove any angled pins (e.g., non-parallel pins) inserted through the osteogenic guide into the bone segment, leaving the parallel-aligned pins (e.g., a pair of parallel pins) in the bone segment. The osteogenic guide can be slid or translated along the parallel-aligned pins until the fixation openings in the osteogenic guide clear the distal ends of the pins. At this point, the osteogenic guide can be separated from the pins, leaving the pins in the bone segment. Next, a compression distractor can be placed over the parallel-aligned pins by passing them through the first and second pin-receiving holes of the compression distractor. The first and second pin-receiving holes of the compression distractor can be aligned with the distal ends of the two pins, and the compression distractor can then be slid or translated toward the bone segment.
[0008] When the first and second pin-receiving holes of the compression distractor are angled relative to each other, the process of installing the compression distractor on the pins causes the pins to move. In particular, the pins can move from being aligned substantially parallel to each other to a position where the pins are angled relative to each other at a non-zero angle defined by the compression distractor in one or more planes, such as two or more planes. As a result, the first and second bone portions into which the pins are inserted can move a distance corresponding to the angular movement of the pins.
[0009] After placing the compression distractor on the pin, the clinician can activate the actuator to move the first and second engagement arms away from each other, thereby moving the bone portions away from each other. This can provide an enlarged separation gap between the bone portions to cleanse the interbone space in anticipation of fixation. For example, the clinician can remove bone chips and / or tissue debris from the interbone space between the two bone portions to further cut or prepare the end faces of one or both bone portions or otherwise prepare them for fixation. The clinician can also activate the actuator to move the first and second engagement arms toward each other, thereby moving the bone portions toward each other. The clinician can move the first and second engagement arms toward each other until the end faces of the bone portions are pressed against each other, thereby applying a compressive force to the bone portions. Next, in some examples, the clinician fixates the bone portions by applying one or more fixation members to the bone portions.
[0010] In one example, a compression distractor is described that includes a first engagement arm having a first pin-receiving hole for receiving a first pin inserted into a first bone portion and a second engagement arm having a second pin-receiving hole for receiving a second pin inserted into a second bone portion. The compression distractor also includes an actuator operably coupled to the first engagement arm and the second engagement arm. The actuator is configured to move the first and second engagement arms away from each other to move the first bone portion away from the second bone portion and to move the first and second engagement arms toward each other to move the first bone portion toward the second bone portion. In this example, it is specified that the first pin-receiving hole is angled relative to the second pin-receiving hole at a non-zero angle.
[0011] Another example describes a method that includes positioning a first fixation opening of an osteogenic guide over a first bone portion and a second fixation opening of the osteogenic guide over a second bone portion. This example specifies that the first and second fixation openings are parallel to one another. The exemplary method also includes inserting a first pin through the first fixation opening into the first bone portion and a second pin through the second fixation opening into the second bone portion. After inserting the first pin into the first bone portion and sliding the osteogenic guide off the first and second pins while still inserting the second pin into the second pin, the method includes inserting a compression distractor over the first pin and the second pin. This example specifies that the compression distractor is inserted over the first and second pins by at least positioning the first pin through a first pin-receiving hole of a first engagement arm of the compression distractor and positioning the second pin through a second pin-receiving hole of a second engagement arm of the compression distractor. The compression distractor has an actuator operably coupled to the first engagement arm and the second engagement arm. This example specifies that the first pin-receiving hole is angled at a non-zero degree angle relative to the second pin-receiving hole such that inserting the compression distractor into the first pin and into the second pin moves the first bone portion relative to the second bone portion.
[0012] The details of one or more embodiments are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will become apparent from the description and drawings, and from the claims. [Brief explanation of the drawings]
[0013] [Figure 1A] 1A and 1B are front views of the foot showing a normal first metatarsal position and an exemplary frontal plane rotational deviation position, respectively. [Figure 1B] 1A and 1B are front views of the foot showing a normal first metatarsal position and an exemplary frontal plane rotational deviation position, respectively.
[0014] [Figure 2A]2A and 2B are top views of the foot showing a normal first metatarsal position and an exemplary transverse plane deviation position, respectively. [Figure 2B] 2A and 2B are top views of the foot showing a normal first metatarsal position and an exemplary transverse plane deviation position, respectively.
[0015] [Figure 3A] 3A and 3B are side views of the foot showing a normal first metatarsal position and an exemplary sagittal plane deviation position, respectively. [Figure 3B] 3A and 3B are side views of the foot showing a normal first metatarsal position and an exemplary sagittal plane deviation position, respectively.
[0016] [Figure 4] FIG. 4 is a perspective view of an exemplary compression distractor according to the disclosure.
[0017] [Figure 5] 5 is a frontal view of the exemplary compression distractor of FIG. 4 illustrating an exemplary angular offset between the pin-receiving holes.
[0018] [Figure 6] 6 is a sagittal view of the exemplary compression distractor of FIG. 4 illustrating an exemplary angular offset between pin-receiving holes.
[0019] [Figure 7] FIG. 7 is a top view of an exemplary osteogenic guide that can be used with a compression distractor.
[0020] [Figure 8] FIG. 8 is a perspective view of an exemplary osteogenic guide, spacer, and tissue removal tool check member that can be used with a compression distractor.
[0021] [Figure 9] Figure 9 is a side perspective view of the foot depicting the osteotomy device inserted into the joint.
[0022] [Figure 10]FIG. 10 is a perspective view of the foot depicting the foot bone positioning guide prior to alignment of the first metatarsal.
[0023] [Figure 11] FIG. 11 is a perspective view of the foot depicting the foot bone positioning guide after alignment of the first metatarsal.
[0024] [Figure 12] FIG. 12 is a perspective view of the foot depicting the foot bone positioning guide after alignment of the first metatarsal and insertion of a spacer into the joint space.
[0025] [Figure 13] FIG. 13 is a perspective view of a foot depicting an osteogenic guide positioned in the foot.
[0026] [Figure 14] FIG. 14 is a perspective view of a foot depicting an osteogenic guide with pins inserted into the osteogenic guide.
[0027] [Figure 15] Figure 15 is a perspective view of the foot illustrating removal of the osteogenic guide.
[0028] [Figure 16] FIG. 16 is a side perspective view of the foot depicting the bony plates that cross the joint between the first and second bones.
[0029] [Figure 17] 17 and 18 are front perspective and side views, respectively, of a compression distractor illustrating an alternative configuration of the first and second engagement arms. [Figure 18] 17 and 18 are front perspective and side views, respectively, of a compression distractor illustrating an alternative configuration of the first and second engagement arms.
[0030] [Figure 19] FIG. 19 is a perspective view of a foot illustrating an exemplary deployment of a compression distractor having a bone contacting portion defining a notch.
[0031] The details of one or more embodiments are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will become apparent from the description and drawings, and from the claims. DETAILED DESCRIPTION OF THE INVENTION
[0032] In general, the present disclosure is directed to devices and techniques for correcting misalignment of one or more bones. The disclosed devices and techniques can be implemented in surgical procedures in which one bone portion is realigned relative to another. In some examples, the techniques are performed on one or more bones of the foot or hand, which are relatively small compared to bones in other parts of the human body. For example, the foregoing description generally refers to exemplary techniques performed on the foot, and more specifically, on the metatarsals and cuneiform bones of the foot. However, the disclosed techniques can be performed on other bones, such as the tibia, fibula, ulna, humerus, femur, or even other bones, and unless otherwise specified, the disclosure is not limited in this respect. However, in some applications, the disclosed techniques are used to correct misalignment between a metatarsal (e.g., the first metatarsal) and a second metatarsal and / or cuneiform bone (e.g., the medial or first cuneiform), such as in hallux valgus correction surgery.
[0033] 1-3 are different views of a foot 200 illustrating examples of anatomical misalignments that can occur and be corrected in accordance with the present disclosure. Such misalignments may be caused by hallux valgus (bunion), natural growth deformities, or other conditions that cause anatomical misalignments. FIGS. 1A and 1B are front views of the foot 200, showing a normal first metatarsal position and an exemplary frontal plane rotational misalignment position, respectively. FIGS. 2A and 2B are top views of the foot 200, showing a normal first metatarsal position and an exemplary transverse plane misalignment position, respectively. FIGS. 3A and 3B are side views of the foot 200, showing a normal first metatarsal position and an exemplary sagittal plane misalignment position, respectively. While FIGS. 1B, 2B, and 3B each illustrate misalignment in the respective plane alone, in practice, the metatarsals may be misaligned in any two of the three planes, or in all three planes. Therefore, it should be understood that the depiction of a single plane of misalignment in each of Figures 1B, 2B, and 3B is for illustrative purposes, and that the metatarsals may be misaligned in multiple planes that are desirably corrected.
[0034] 1A and 2A, a foot 200 is comprised of multiple bones, including a first metatarsal 210, a second metatarsal 212, a third metatarsal 214, a fourth metatarsal 216, and a fifth metatarsal 218. The metatarsals are distally connected to phalanges 220, and more specifically, each is connected to a respective proximal phalanx. The first metatarsal 210 is proximally connected to a medial cuneiform 222, the second metatarsal 212 is proximally connected to a middle cuneiform 224, and the third metatarsal is proximally connected to a lateral cuneiform 226. The fourth and fifth metatarsals 216, 218 are proximally connected to a cuboid 228. The joints 230 between the metatarsals and the respective cuneiform bones (e.g., first metatarsal 210 and medial cuneiform 222) are called tarsometatarsal ("TMT") joints. The joints 232 between the metatarsals and the respective proximal phalanges are called metatarsophalangeal joints. The angle 234 between adjacent metatarsals (e.g., first metatarsal 210 and second metatarsal 212) is called the intermetatarsal angle ("IMA").
[0035] As previously mentioned, FIG. 1A is a frontal view of a foot 200 illustrating a typical position of the first metatarsal 210. The frontal plane, also known as the coronal plane, is generally considered to be any vertical plane that divides the body into anterior and posterior sections. In the foot 200, the frontal plane is a vertically extending plane, perpendicular to an axis extending proximally to distally along the length of the foot. FIG. 1A illustrates the first metatarsal 210 in a typical rotational position in the frontal plane. FIG. 1B illustrates the first metatarsal 210 with a frontal plane rotational deformation characterized by a rotation angle 236 relative to the ground, as indicated by line 238.
[0036] FIG. 2A is a top view of a foot 200 showing a typical position of the first metatarsal 210 in a transverse plane. The transverse plane, also known as the horizontal, axial, or transaxial plane, is considered any plane that divides the body into superior and inferior portions. In the foot 200, the transverse plane is a horizontally extending plane, perpendicular to an axis extending dorsally to plantarly (top to bottom) across the foot. FIG. 2A shows the first metatarsal 210 with a typical IMA 234 in the transverse plane. FIG. 2B shows the first metatarsal 210 with a transverse plane rotational deformity characterized by a larger IMA caused by the distal end of the first metatarsal 210 pivoting medially relative to the second metatarsal 212.
[0037] FIG. 3A is a lateral view of a foot 200 showing a typical position of the first metatarsal 210 in the sagittal plane. The sagittal plane is a plane parallel to the sagittal suture, which divides the body into right and left halves. In the foot 200, the sagittal plane is a vertically extending plane, perpendicular to an axis extending from proximal to distal along the length of the foot. FIG. 3A shows the first metatarsal 210 with a typical rotational position in the sagittal plane. FIG. 3B shows the first metatarsal 210 with a sagittal plane rotational deformation characterized by a rotation angle 240 relative to the ground, as indicated by line 238.
[0038] A compression distractor according to the present disclosure may be useful during bone positioning procedures to correct anatomical misalignment of a bone or bones. In some applications, the compression distractor helps establish and / or maintain realignment between a metatarsal and an adjacent cuneiform bone. The metatarsal undergoing realignment may be anatomically misaligned in the frontal, transverse, and / or sagittal planes, as illustrated and discussed with respect to Figures 1-3 above. Therefore, realignment may involve releasing the misaligned metatarsal for realignment and then realigning the metatarsal in one or more planes, two or more planes, or all three planes. After the metatarsal is suitably realigned, it can be immobilized to hold and maintain the realigned position.
[0039] While the metatarsals can have a variety of anatomically aligned and misaligned positions, in some instances, the term "anatomically aligned position" means that the angle of the long axis of the first metatarsal 210 relative to the long axis of the second metatarsal 212 is about 10 degrees or less (e.g., 9 degrees or less) in the transverse and / or sagittal planes. In certain embodiments, the anatomical misalignment can be corrected in both the transverse and frontal planes. In the transverse plane, a normal IMA 234 between the first metatarsal 210 and the second metatarsal 212 is less than about 9 degrees. An IMA 234 of about 9 degrees to about 13 degrees is considered a mild misalignment of the first and second metatarsals. An IMA 234 of greater than about 16 degrees is considered a severe misalignment of the first and second metatarsals. In some embodiments, methods and / or devices according to the present disclosure are utilized to anatomically align the first metatarsal 210 by positioning the first metatarsal at a different angle relative to the second metatarsal, reducing the IMA from greater than 10 degrees to about 10 degrees or less (e.g., an IMA of 9 degrees or less, or an IMA of about 1-5 degrees), including up to a negative angle of about -5 degrees or until it interferes with the second metatarsal.
[0040] In the frontal plane, a normal first metatarsal is positioned so that its crest is generally perpendicular to the ground and / or its sesamoid is generally parallel to the ground and positioned below the metatarsal. This position can be defined as 0 degrees of metatarsal rotation. In a misaligned first metatarsal, the metatarsal may rotate axially from about 4 degrees to about 30 degrees or more. In some embodiments, methods and / or devices according to the present disclosure are utilized to anatomically align the metatarsal by rotating it relative to the adjacent cuneiform bone, thereby reducing metatarsal rotation from about 4 degrees or more to less than 4 degrees (e.g., about 0 to 2 degrees).
[0041] A compression distractor according to the present disclosure may be useful for distracting a metatarsal bone displaced from an adjacent cuneiform bone to provide access to the end faces of the bones and / or tarsometatarsal joint. A compression distractor may also be useful for applying a compressive force to the metatarsal bone and adjacent cuneiform bone (e.g., after forming the end faces of the bones) to press the bones together and facilitate fixation. Additionally or alternatively, a compression distractor may impart and / or maintain relative movement between the metatarsal bone and the adjacent cuneiform bone, e.g., rotation and / or pivoting of one bone relative to the other. For example, the angular offset provided by the pin-receiving holes of the compression distractor may be effective in moving the metatarsal bone from an anatomically displaced position to an anatomically aligned position. When the compression distractor translates on pins inserted into the metatarsal bone and cuneiform bone, the angular offset of the pin-receiving holes may cause the pins to move from a substantially parallel state to the angular alignment determined by the pin-receiving holes. The resulting movement of the metatarsals relative to the cuneiforms caused by this movement helps position the metatarsals in an aligned position.
[0042] 4 is a perspective view of an exemplary compression distractor 100 in accordance with the disclosure. The compression distractor 100 is illustrated as having a first engagement arm 102 and a second engagement arm 104. The compression distractor 100 also includes an actuator 106 operably coupled to the first engagement arm 102 and the second engagement arm 104. The actuator 106 can be actuated to move the two engagement arms toward and away from each other to adjust the separation distance between the two arms. Additionally, as will be discussed in more detail, each engagement arm includes at least one pin-receiving hole configured to receive a pin inserted into bone.
[0043] For example, the first engagement arm 102 can include a first pin-receiving hole 108, and the second engagement arm 104 can include a second pin-receiving hole 110. The first pin-receiving hole 108 can receive a first pin 112, and the second pin-receiving hole 110 can receive a second pin 114. The first pin 112 and the second pin 114 can be inserted into different bones or bone portions during a procedure. In the case of a bone realignment procedure, for example, the first pin 112 can be inserted into a metatarsal bone (e.g., first metatarsal 210) and the second pin 114 can be inserted into a cuneiform bone (e.g., medial cuneiform 222). The pin-receiving holes can secure the compression distractor 100 to the bone being compressed and / or distracted via a pin inserted through the hole into the underlying bone. Additionally or alternatively, the pin-receiving holes can be used to provide relative movement between one bone into which the first pin 112 is inserted and another bone into which the second pin 114 is inserted.
[0044] For example, the first pin receiving holes 108 and the second pin receiving holes 110 can be angled relative to one another at a non-zero angle such that when the compression distractor 100 is inserted over a set of substantially parallel pins, the angled receiving holes cause the pins to move relative to one another and align with the pin receiving holes. The direction and degree of movement imposed by the angled pin receiving holes of the compression distractor 100 can vary depending on the desired surgical application for which the compression distractor is being used. For example, in the case of a misaligned metatarsal, such as in a hallux valgus procedure, the pin receiving holes can be angled to impart frontal plane rotation and / or sagittal plane translation. As a result, when the compression distractor 100 is installed over the pin locations of the metatarsal and adjacent cuneiform bones, the angled pin receiving holes can help to rotate the metatarsal in the frontal plane and / or translate in the sagittal plane (e.g., downward or plantar) relative to the cuneiform bone, correcting the metatarsal misalignment.
[0045] FIG. 5 is a frontal view of the compression distractor 100 illustrating an exemplary angular offset between the first pin receiving hole 108 and the second pin receiving hole 110. In this example, the two pin receiving holes are angled relative to each other in the frontal plane by an angle 116. The angle 116 can be measured between two linear pins (e.g., the first pin 112 and the second pin 114) inserted through the respective receiving holes from a frontal perspective. The degree of angular offset between the first pin receiving hole 108 and the second pin receiving hole 110 can vary, but for metatarsal realignment procedures, the angle 116 can be in the range of 2° to 20°, e.g., 6° to 15°, or 8° to 12°, or approximately 10°. The two pin receiving holes can be offset in a direction that laterally rotates the metatarsals when the compression distractor 100 is placed on the first and second pins 112, 114. For example, when the compression distractor 100 is positioned on the medial side of the foot, the first pin receiving hole 108 may be angled to rotate the first pin 112 relative to the second pin 114 toward the lateral side of the foot.
[0046] In addition to or instead of providing a frontal plane angle, the compression distractor 100 can be configured to impart sagittal plane rotation when placed on the first and second pins 112, 114. For example, when placed on substantially parallel first and second pins 112, 114 positioned at the metatarsals and cuneiform bones, respectively, the angle of the first and second pin holes 108, 110 can cause the metatarsals to rotate or plantarly flex (e.g., the distal ends of the metatarsals rotate plantarly about the TMT joints).
[0047] FIG. 6 is a sagittal view of the compression distractor 100 illustrating another exemplary angular offset between the first pin receiving hole 108 and the second pin receiving hole 110. In this example, the two pin receiving holes are angled relative to each other in the sagittal plane by an angle 118. The angle 118 can be measured between two linear pins (e.g., the first pin 112 and the second pin 114) inserted through the respective receiving holes from the perspective of the sagittal plane. The degree of angular offset between the first pin receiving hole 108 and the second pin receiving hole 110 can vary, but for metatarsal realignment procedures, the angle 118 can be in the range of 5° to 12°, e.g., 7° to 10°, or 8° to 9°, or approximately 8.5°. The two pin receiving holes can be offset in a direction that rotates the metatarsals in the sagittal plane (e.g., downward or plantar) when the compression distractor 100 is installed on the first and second pins 112, 114.
[0048] Generally, the features described as pin-receiving holes may be spaces extending linearly through the body of the distractor 100 and configured (e.g., sized and / or shaped) to receive pins inserted into bone. The pin-receiving holes may have any polygonal (e.g., square, rectangular) or arcuate (e.g., curved, oval) shape, although the pin-receiving holes may typically have a circular cross-sectional shape. In some examples, the pin-receiving holes have diameters ranging from 0.1 mm to 10 mm, such as 0.5 mm to 4 mm. The pin-receiving holes may have lengths (e.g., extending through the thickness of the first engagement arm 102 or the second engagement arm 104) ranging from 5 mm to 50 mm, such as 10 mm to 25 mm.
[0049] The compression distractor 100 can have any suitable number of pin-receiving holes. Generally, providing multiple pin-receiving holes on both sides of the compression distractor 100 can be useful to provide alternative angulation or translation options to a clinician using the compression distractor. For example, the compression distractor 100 can have multiple pin-receiving holes for use with the first pin 112 and / or the second pin 114. During a surgical procedure, a clinician can select a particular pin-receiving hole from the multiple pin-receiving holes into which the first pin 112 and / or the second pin 114 will be inserted. The clinician can select the combination of pin-receiving holes based on the amount and direction of movement the clinician desires the first bone to move relative to the second bone when placing the compression distractor over the first and second pins 112, 114. After selecting the desired pin receiving hole combination, the clinician can orient the distal ends of the first and second pins 112, 114 toward the corresponding selected pin receiving holes and then translate the compression distractor 100 downward from the distal end toward the proximal end of the pins.
[0050] It should be understood that the compression distractor 100 can have multiple pin receiving holes for the first pin 112 and / or the second pin 114, although the disclosure is not limited in this regard. In other configurations, the compression distractor 100 can have only a single pin receiving hole through which the first pin 112 and / or the second pin 114 can be inserted. In still other configurations, the compression distractor 100 can have one or more pin receiving hole(s) that rotate and / or slide within one or more slots to provide an adjustable angle, allowing a clinician to adjust the angular alignment of the first and / or second pin receiving holes 108, 110.
[0051] In the example of Figure 4, the compression distractor 100 is illustrated as having two pin receiving holes associated with a first pin 112 and two pin receiving holes associated with a second pin 114. In particular, Figure 4 illustrates that the first engagement arm 102 has the aforementioned first pin receiving hole 108 and the second engagement arm 104 has the aforementioned second pin receiving hole 110. Additionally, the first engagement arm 102 is illustrated as having a third pin receiving hole 120 and the second engagement arm 104 is illustrated as having a fourth pin receiving hole 122. The first and second engagement arms 102, 104 can each have fewer pin receiving holes (e.g., one) or more pin receiving holes (e.g., three, four, or more).
[0052] In some configurations, the third pin receiving hole 120 is angled relative to the fourth pin receiving hole 122 at a non-zero degree angle in a second plane different from the first plane in which the first pin receiving hole 108 is angled relative to the second pin receiving hole 110. For example, the first pin receiving hole 108 may be angled relative to the second pin receiving hole 110 in the frontal and / or sagittal planes. The third pin receiving hole 120 may be parallel to the second pin receiving hole 110 in the frontal plane but angled relative to the second pin receiving hole in the sagittal plane. Furthermore, the fourth pin receiving hole 122 may be parallel to the first pin receiving hole 108 in the frontal plane but angled relative to the first pin receiving hole in the sagittal plane. The third and fourth pin receiving holes 120, 122 may be angled relative to each other and / or relative to the first and second pin receiving holes 108, 110 at any of the angles described above. 4, a clinician desiring both frontal and sagittal translation can use the first and second pin holes 108, 110. In contrast, if the clinician desires sagittal translation but not frontal translation, the clinician can use the first and fourth pin-receiving holes 108, 122.
[0053] As briefly discussed above, the compression distractor 100 can open and close to compress and distract the bone to which it is secured. To facilitate movement, the compression distractor 100 is illustrated as having an actuator 106. The actuator 106 is configured to control the movement of the first engagement arm 102 relative to the second engagement arm 104. The actuator 106 can be implemented using any feature that provides controllable relative movement between the two engagement arms, such as rotational movement, gliding movement, or other relative translational movement. In some configurations, the actuator 106 is configured to move the first and second engagement arms 102, 104 at least 1 mm away from each other during distraction, such as a distance in the range of 1 mm to 45 mm, a distance in the range of 1 mm to 5 mm, or a distance in the range of 1 mm to 2.5 mm. The actuator 106 can be actuated during compression until the bone surfaces to which the compression distractor 100 is attached are suitably compressed and / or the sidewall surfaces of the first and second engagement arms 102, 104 contact one another.
[0054] 4, the actuator 106 is illustrated as including a shaft 124 connected to the first engagement arm 102 and the second engagement arm 104. The shaft 124 may be threaded, and the actuator 106 may further include a knob 126 coupled to the shaft. Rotating the knob 126 in one direction may move the first engagement arm 102 closer to the second engagement arm 104, while rotating the knob in the opposite direction may move the first engagement arm away from the second engagement arm.
[0055] To secure the actuator 106 to the compression distractor 100, the actuator can be fixedly connected to one of the arms. For example, the shaft 124 of the actuator 106 can be fixedly attached along its length to the first engagement arm 102 and rotatable relative to the arm. As a result, when the knob 126 is rotated, the second engagement arm 104 can move along the length of the shaft 124 toward and / or away from the first engagement arm 102. This provides relative movement between the two arms while the first engagement arm 102 remains in a fixed position relative to the actuator 106.
[0056] 4, the first engagement arm 102 is shown extending from a distal end 128A to a proximal end 128B. Similarly, the second engagement arm 104 is shown extending from a distal end 130A to a proximal end 130B. The actuator 106 is positioned adjacent the proximal ends 128B, 130B of the first and second engagement arms 102, 104, respectively, such as the proximal halves of the arms in the configuration shown. Offsetting the actuator 106 from the pin-receiving hole can be useful, for example, to provide clearance for a clinician to manipulate the actuator when the compression distractor 100 is inserted over a pin placed in bone. In the case of foot surgery, the first and second engagement arms 102, 104 may have lengths that affect positioning the actuator 106 so that it is offset medially from the foot being treated, while the first pin receiving hole 108 engages with a first pin 112 inserted in a metatarsal bone and the second pin receiving hole 110 engages with a second pin 114 engaged with a cuneiform bone.
[0057] To help stabilize the first engagement arm 102 relative to the second engagement arm 104 during movement along the shaft 124, the compression distractor 100 may also include one or more unthreaded shafts extending parallel to the threaded shaft. In FIG. 4 , for example, the actuator 106 has a first unthreaded shaft 132A and a second unthreaded shaft 132B (collectively referred to as "unthreaded shafts 132"). The unthreaded shaft 132 extends parallel to the threaded shaft 124 and helps stabilize the second engagement arm 104 as it moves along the threaded shaft toward and away from the first engagement arm 102. The threaded shaft 124 is shown extending through a threaded opening in the sidewall of the second engagement arm 104, and the unthreaded shaft 132 Second Engagement Arm 104 1. The casing 10 is shown extending through an unthreaded opening in the side wall of the casing 10.
[0058] The first engagement arm 102 and the second engagement arm 104 can have a variety of different sizes and shapes. Generally, each engagement arm can define a length that offsets the pin-receiving hole from the actuator 106. In some examples, the distal end 128A of the first engagement arm 102 defines a first pin block 134, and / or the distal end 130A of the second engagement arm 104 defines a second pin block 136. The pin block can be the region of the respective engagement arm that defines the pin-receiving hole and through which the pin-receiving hole extends. The first and second pin blocks 134, 136 can have a thickness that is greater than the thickness of the remainder of the engagement arm. For example, as shown, the pin blocks 134, 136 can extend downward (e.g., plantar) from the engagement arm and / or the remainder of the actuator 106.
[0059] In FIG. 4 , the first engagement arm 102 is illustrated as having the same length as the second engagement arm 104. As a result, the distal end 128A of the first engagement arm is parallel to the distal end 130A of the second engagement arm. In other configurations, one engagement arm may be longer than the other to provide an offset. For example, the first engagement arm 102 may be longer than the second engagement arm 104, e.g., extending further laterally than the second engagement arm 104 when applied to the foot being treated. This configuration may aid in providing transverse translation (e.g., rotation) of the metatarsal relative to the cuneiform bone and closing the IM angle during hallux valgus correction treatment.
[0060] The compression distractor 100 can be fabricated from any suitable material or combination of materials, such as metal (e.g., stainless steel) and / or polymeric materials. In some configurations, the compression distractor 100 is fabricated from a radiolucent material so that it is relatively transparent to x-rays and other forms of radiation, such as thermoplastics and carbon fiber materials. Such materials are useful to avoid obstructing visualization of the bone using imaging equipment when the bone positioning guide is positioned on the bone.
[0061] A compression distractor according to the present disclosure can be used as part of a surgical procedure in which at least two pins are inserted into different bones or different portions of the same bone. The at least two pins can be inserted in a generally parallel alignment and / or the pins can be realigned during the surgical procedure (e.g., before installation of the compression distractor 100) to become substantially parallel. The two pins can be substantially parallel in that the pins are positioned side-by-side and have substantially the same continuous distance between them in each of three planes (e.g., the distance varies by less than 10%, e.g., less than 5%, with different continuous distances in different planes across the length of any given plane). The compression distractor 100 can be inserted into parallel pins by threading the pins into the pin-receiving holes of the device, thereby moving the pins from a substantially parallel alignment to an angled alignment determined by the angle of the pin-receiving holes. The compression distractor 100 may then be used to distract the bone portions into which the pins are inserted (e.g., by actuating the actuator 106 to pull the bone portions away from each other) and / or to compress the bone portions into which the pins are inserted (e.g., by actuating the actuator 106 to move the bone portions toward each other).
[0062] In some examples, the compression distractor 100 is used as part of a metatarsal realignment procedure in which the metatarsal is realigned relative to the adjacent cuneiform and / or metatarsal in one or more planes, such as two or three planes. Additional details regarding examples of bone realignment techniques and devices in which the compression distractor 100 can be used may be found in U.S. Patent No. 9,622,805, entitled "BONE POSITIONING AND PREPARING GUIDE SYSTEMS AND METHODS," filed December 28, 2015, and issued April 18, 2017; U.S. Patent No. 9,936,994, entitled "BONE POSITIONING GUIDE," filed July 14, 2016, and issued April 10, 2018; and U.S. Patent Publication No. 2017 / 0042599, entitled "TARSAL-METATARSAL JOINT PROCEDURE UTILIZING FULCRUM," filed August 14, 2016. The entire contents of each of these documents are incorporated herein by reference.
[0063] The pins on which the compression distractor 100 is mounted can be used to pin and / or guide another medical instrument used during a surgical technique. For example, the first and second pins 112, 114 can be used to pin a first medical instrument to the bone or bone portion being treated. The medical instrument can be removed over the parallel pins, leaving the pins inserted in the bone or bone portion, and then the compression distractor 100 can be placed over the pins.
[0064] For example, in the case of a metatarsal realignment procedure, the first and second pins 112, 114 can be used to pin an osteogenic guide to the foot being treated. The osteogenic guide can be used to form the end surfaces of the metatarsals and the adjacent end surfaces of the corresponding cuneiform bones. The osteogenic guide can be removed from the first and second pins and the compression distractor 100 installed on the pins. When the compression distractor 100 is positioned over the first and second pins 112, 114, the angularly aligned pin-receiving holes can move the first metatarsal in one or more planes to facilitate realignment. The compression distractor 100 can be manipulated to open the joint space between the metatarsal and cuneiform bones, for example, to facilitate joint cleansing, and can be further manipulated to compress the two bones together for fixation.
[0065] FIG. 7 illustrates an exemplary osteogenic guide 150 that can be used as part of a surgical procedure involving the distractor 100. In some examples, the osteogenic guide 150 includes a body 154 defining a first guide surface 160 for defining a first formation surface and a second guide surface 164 for defining a second formation surface. A tissue removal instrument (e.g., a saw, rotary burr, osteotome, etc., not shown) can be aligned with the surface to remove tissue (e.g., to remove cartilage or bone and / or cut bone). The first and second guide surfaces 160, 164 can be spaced apart from one another by a distance (e.g., about 2 millimeters to about 10 millimeters, e.g., about 4 to about 7 millimeters). In the illustrated embodiment, the first and second guide surfaces are parallel, such that cuts into adjacent bones using the guide surfaces are approximately parallel.
[0066] In some configurations, as shown in FIG. 7 , the first opposing surface 166 is positioned adjacent to the first guide surface 160, and / or the second opposing surface 168 is positioned adjacent to the second guide surface 164. In such configurations, the distance between the first guide surface and the first opposing surface defines a first guide slot, and the distance between the second guide surface and the second opposing surface defines a second guide slot. Each slot can be dimensioned to receive a tissue removal instrument for forming the bone epiphysis. The first and second slots can be parallel or oblique. In the illustrated example, the opposing surfaces each include a gap, so that the surfaces are not a single, continuous surface. In other embodiments, the opposing surfaces can be a single, continuous surface lacking any such gap.
[0067] An opening 170 can be defined by the body 154 between the first and second guide surfaces. The opening can be a region between the guide surfaces that is useful for allowing a practitioner to have a visual path to the bone during bone formation and / or to receive instruments. In the configuration shown, the opening extends across the body a distance from a surface 172 opposite the first opposing surface 166 to a surface 174 opposite the second opposing surface 168.
[0068] The illustrated osteogenic guide also includes a first end 176 extending from the body 154 in a first direction and a second end 178 extending from the body in a second direction. The second direction may be different from the first direction (e.g., the opposite direction). As shown, each of the first and second ends may include at least one fixation opening 180 configured to receive a fixation pin for securing the osteogenic guide to the underlying bone. For example, the first end 176 of the osteogenic guide 150 may define a first fixation opening through which the first pin 112 ( FIG. 4 ) is inserted, and the second end 178 of the osteogenic guide 150 may define a second fixation opening through which the second pin 114 ( FIG. 4 ) is inserted. These two fixation openings may be aligned parallel to one another such that the first and second pins 112, 114 extend through parallel holes. The first end 176 and / or second end 178 of the osteogenic guide 150 may also define one or more additional fixation openings that are angled (at a non-zero degree angle) or otherwise inclined relative to the two parallel fixation openings.
[0069] During use, a clinician can insert two parallel pins through the fixation openings 180 and, optionally, one or more angled pins through one or more angled fixation openings. This combination of parallel pins and angled pins can prevent the osteogenic guide 150 from being dislodged from the underlying bone during a procedure. When the clinician has completed using the osteogenic guide, the angled pin(s) can be removed, leaving two parallel pins inserted into the underlying bone. The osteogenic guide 150 can be slid or otherwise moved up or down from the parallel pins, after which the compression distractor 100 can be inserted over the pins.
[0070] In some examples shown in FIG. 7, the osteogenic guide 150 can also include a first adjustable stabilizing member 182 engaged with the first end 176 and / or a second adjustable stabilizing member 184 engaged with the second end 178. Each of the members can be threaded and engage with a threaded opening defined by the end. By adjusting the stabilizing members, the height of each end can be adjusted relative to the bone. In some embodiments, as shown, the stabilizing members are cannulated so that they can receive fixation pins.
[0071] Referring to FIG. 8 , the osteogenic guide 150 may include or be used with a spacer 188 extending downwardly from the body 154. The spacer 188 may be configured to be placed within a joint (e.g., within a TMT joint). In some embodiments, the spacer 188 is selectively engageable with and removable from the body of the osteogenic guide. The spacer may have a first portion 190 configured to extend into the joint space and a second portion 192 engageable with the body 154. In the embodiment shown, the spacer may be received within the opening 170 such that the spacer extends from the body between the first and second guide surfaces. Such a spacer may be useful for positioning the body in a desired position relative to the joint and for properly positioning the guide relative to the bone being cut in two or more planes (e.g., three planes selected from two or more coronal, planar, transverse, and sagittal planes). The distance between the spacer and the first guide surface can define a length of tissue removal (e.g., bone or cartilage to be cut) from the first bone, and the distance between the spacer and the second guide surface can define a length of tissue removal (e.g., bone or cartilage to be cut) from the second bone.
[0072] As also shown in FIG. 8 , the osteogenic guide 150 may include or be used with a tissue removal position check member 194. The tissue removal check member 194 may be engageable with the body 154 and configured to extend to a first bone and a second bone. The tissue removal position check member may have a first portion 196 configured to extend to contact the first and second bones and a second portion 198 engageable with the body. In the embodiment shown, the tissue removal check member 194 is configured to extend into the body 154 on both the first and second guide surfaces. The tissue removal position check member 194 may be useful to allow the practitioner to see where a tissue removal instrument guided by the surface will contact the bone to be formed.
[0073] Bone formation facilitated by the osteogenic guide 150 can be useful, for example, to facilitate contact between the leading edges of adjacent bones separated by a joint, or between different portions of a single bone separated by a fracture, for example, in bone alignment and / or fusion procedures. The bone can be formed using one or more osteogenic techniques. In some applications, the bone is formed by cutting the bone. The bone can be cut transversely to establish a new epiphysis facing the opposite bone portion. Additionally or alternatively, the bone can be formed by morselizing the end of the bone. The epiphysis can be morselized using any convenient tool, such as a rotary burr, osteotome, or drill. The epiphysis can be morselized by grinding, drilling, crushing, pulping, and / or breaking the epiphysis into small pieces to facilitate deformable contact with the opposite bone portion.
[0074] During a surgical technique utilizing the compression distractor 100, a bone may be moved from an anatomically misaligned position to an anatomically aligned position relative to another bone. Furthermore, both the end of the moved bone and the opposing end of the adjacent bone may be prepared for fixation. In some applications, at least one end of the moved bone and / or the other bone is prepared after moving the bone into the aligned position. In other applications, at least one end of the moved bone and / or the other bone is prepared before moving the bone into the aligned position.
[0075] Movement of one bone relative to another can be achieved using one or more instruments and / or techniques. In some instances, bone movement is achieved using a bone positioning device that applies a force to one bone at a single location so that the bone translates and rotates in response to the force. This can be achieved, for example, using a bone positioning guide that includes a bone engaging member, a tip, a mechanism that urges the bone engaging member and tip toward each other, and an actuator that actuates the mechanism. Additionally or alternatively, bone movement can be achieved using the compression distractor 100 by imparting movement of one bone relative to another when the compression distractor is positioned over substantially parallel pins, moving the pins from their substantially parallel alignment and causing movement of the underlying bone in one plane (e.g., frontal, sagittal, transverse), two or more planes, or all three planes. Additionally or alternatively, the clinician can physically grasp the bone, either by direct contact with the bone or indirectly (e.g., inserting a K-wire, grasping with a tenaculum, etc.), and facilitate the transfer by moving their hand over the bone.
[0076] Regardless of how the transfer is achieved, surgical techniques may or may not utilize a fulcrum. A fulcrum may provide a structure around which one bone rotates and / or pivots relative to another. The fulcrum may establish and / or maintain space between adjacent bones being transferred, preventing lateral translation or base shifting of the bones during rotation and / or pivoting. For example, to help prevent the proximal-most base of the first metatarsal 210 from shifting toward the proximal-most base of the second metatarsal 212, a clinician may insert a fulcrum into the notch between the first metatarsal 210 and the second metatarsal 212 at the base of the metatarsal (e.g., each adjacent metatarsal) before transferring the first metatarsal. The fulcrum may provide a point around which the first metatarsal 210 can rotate and / or pivot, helping to minimize or avoid base compression between the first and second metatarsals. Additionally, the use of the fulcrum allows the first metatarsal 210 and medial cuneiform 222 to better angle relative to the guide slots positioned on the end faces of the bones, providing a better cutting angle through the guide slots than would be possible without the use of the fulcrum, which helps reduce or eliminate unwanted springback or return positioning of the first metatarsal 210 after the initial realignment of the metatarsals.
[0077] An exemplary method for performing a bone alignment procedure utilizing a compressor distractor according to the present disclosure will now be described with reference to Figures 7-16, which depict a foot 200 having a first metatarsal 210, a medial cuneiform 222, and a second metatarsal 212. Unless otherwise specified, the exemplary steps may be performed in any order and need not be performed in the order described.
[0078] After conventional surgical preparation and access, an osteotomy instrument 296 can be inserted into the joint (e.g., the first tarsometatarsal joint) to free soft tissue and / or resect plantar ligaments from the base of the first metatarsal 210, as shown in FIG. 9 . Removing the plantar ligaments can involve severing the plantar ligaments from the first metatarsal 210 so that the face of the first metatarsal is generally planar. This step helps to shift the joint to facilitate deformity correction. In some embodiments, the dorsolateral ligaments of the first metatarsal can also be resected to create space for deformity correction (e.g., for rotation of the first metatarsal). In certain embodiments, the portion of the metatarsal base facing the medial cuneiform can be removed during this shifting step.
[0079] An incision can be made, and if a bone locating instrument is used, the tip 50 of the bone locating guide 10 is inserted on the lateral side of a metatarsal bone other than the first metatarsal bone 210, such as the second metatarsal bone 212. As shown in FIG. 10 , the tip can be positioned proximal to the base of the interface between the second metatarsal bone 212 and the third metatarsal bone 214. The surface of the bone engaging member 40 can be located on the proximal portion of the first metatarsal bone 210. In some embodiments, the bone engaging member engages the medial eminence of the first metatarsal bone 210. As shown, the body 20 of the locating guide can be generally perpendicular to the long axis of the second metatarsal bone 212.
[0080] To help avoid base shift, the clinician can insert a fulcrum into the notch between the first metatarsal 210 and the second metatarsal 212 at the base of the metatarsals (e.g., each adjacent cuneiform) before actuating the bone positioning guide 10 or otherwise moving the first metatarsal relative to the medial cuneiform. The fulcrum can provide a point about which the first metatarsal 210 can rotate and / or pivot while helping to minimize or avoid base compression between the first and second metatarsals.
[0081] In applications utilizing the bone positioning guide 10, an actuator on the bone positioning guide is actuated to reduce the angle (transverse plane angle between the first and second metatarsals) and rotate the first metatarsal about its axis (frontal plane axis rotation). The first metatarsal 210 can be properly positioned relative to the medial cuneiform 222 by moving the bone positioning guide of the bone engagement member 40 relative to the tip 50 of the bone positioning guide. In some embodiments, such movement simultaneously pivots the first metatarsal relative to the cuneiform and rotates the first metatarsal about its longitudinal axis to an anatomically correct position, correcting the transverse plane deformity and the frontal plane deformity. However, again, other applications utilizing the compression distractor 100 may be performed without utilizing the bone positioning guide 10.
[0082] Regardless of whether a bone positioning guide 10 is used, an exemplary technique can include positioning an articular spacer 188, which can be positioned in the joint between the first metatarsal and the medial cuneiform bone, as illustrated in FIGURE 12. An osteogenic guide 150 can be placed over and engaged with the articular spacer 188 to set the position and orientation of the osteogenic guide relative to the joint, as shown in FIGURE 13. In other embodiments, the osteogenic guide 150 is placed on the bone without the use of an articular spacer 188 to aid in positioning.
[0083] As depicted in FIG. 14 , one or more fixation pins can be inserted into openings in the osteogenic guide 150 to secure the guide to the first metatarsal 210 and the medial cuneiform 222. The fixation pins inserted into the openings in the osteogenic guide 150 include a first fixation pin 112 and a second fixation pin 114. The first and second fixation pins 112, 114 can be inserted in a substantially parallel alignment. The first and second fixation pins 112, 114 can protrude at least 25 mm, e.g., at least 50 mm, or at least 75 mm, from the surface of the bone into which they are inserted. To help prevent movement of the osteogenic guide 150 during the tissue removal step, one or more additional pins can be inserted in an oblique or converging orientation. After pin insertion, the spacer 188 (if used) can optionally be removed in embodiments having a selectively engageable spacer.
[0084] In some applications, the end of the first metatarsal 210 facing the medial cuneiform 222 can be prepared with a tissue removal instrument 296 guided by the guide surface of the osteotomy guide 150 (e.g., inserted through a slot defined by the first guide surface and the first-facing surface). In some embodiments, preparation of the end of the first metatarsal 210 occurs after at least partially aligning the bones, for example, by actuating the bone positioning guide 10 before preparing the end of the first metatarsal 210. In other embodiments, preparation of the end of the first metatarsal 210 occurs before aligning the bones, for example, by preparing the end of the first metatarsal 210 before placing the compression distractor 100 to cause the realignment.
[0085] In addition to forming the end of the first metatarsal 210, the end of the medial cuneiform 222 facing the first metatarsal 210 can be formed with a tissue removal instrument 296 guided by the guide surface of the osteogenic guide 150 (e.g., inserted through a slot defined by the second guide surface and the second opposing surface). In some embodiments, forming the end of the medial cuneiform 222 occurs after alignment of the bones. In yet other embodiments, forming the end of the medial cuneiform 222 occurs before alignment of the bones. In embodiments involving cutting bone or cartilage, the cuneiform cut and the metatarsal cut can be parallel, coincident cuts. In some examples, a saw blade can be inserted through a first slot to cut a portion of the medial cuneiform, and a saw blade can be inserted through a second slot to cut a portion of the first metatarsal.
[0086] As shown in FIG. 15 , any angled / converging pins can be removed, and the osteogenic guide 150 can be lifted off the substantially parallel first and second pins 112, 114. These substantially parallel pins can receive the compression distractor 100. For example, a clinician can position the compression distractor 100 so that the underside of the first pin-receiving hole 108 is positioned over the first pin 112 and the underside of the second pin-receiving hole 110 is positioned over the second pin 114. The clinician can then slide the compression distractor 100 over the pins toward the underlying bone, for example, until the underside of the compression distractor is adjacent to or in contact with the underlying bone. Prior to placing the compression distractor over the pins, the clinician can adjust the spacing between the first engagement arm 102 and the second engagement arm 104 by actuating the actuator 106 until the separation distance corresponds to the spacing between the first pin 112 and the second pin 114. In the process of inserting the compression distractor 100 into the pins, the angle between the first pin receiving hole 108 and the second pin receiving hole 110 can shift the first and second pins 112, 114 from their substantially parallel alignment to a non-parallel alignment corresponding to the angular position of the pin receiving holes. As the first and second pins 112, 114 move relative to one another, the first metatarsal 210 can move relative to the medial cuneiform 222 in a direction and distance corresponding to the movement of the first pin 112 relative to the second pin 114.
[0087] In applications where a bone positioning guide 10 is utilized, the bone positioning guide 150 may be removed before or after the osteogenic guide 150 is removed and the compression distractor 100 is placed. In either case, in some instances, a temporary fixation device such as an olive pin, k-wire, or other fixation structure may be used to maintain the position of the underlying bone (e.g., the first metatarsal 210 relative to the medial cuneiform 222) while the osteogenic guide 150 is removed and the compression distractor 100 is placed.
[0088] With the compression distractor 100 pinned to the underlying bones (e.g., the first metatarsal 210 and the medial cuneiform 222), the actuator 106 can be actuated to distract the underlying bones. For example, the clinician can turn the knob 126 to move the second engagement arm 104 away from the first engagement arm 102, opening or widening the gap between the underlying bones. Once pinned to the first metatarsal 210 and the medial cuneiform 222, the clinician can actuate the actuator 106 to open the TMT joint.
[0089] With the underlying bone distracted, the clinician can cleanse or otherwise prepare the space between the bones and / or the end surfaces of one or both bones. The clinician can cleanse the space by removing excess cartilage, bone, and / or other cellular debris that may be present naturally or that may have been created during the bone formation step that may inhibit the injection.
[0090] Regardless of whether the clinician utilizes the compression distractor 100 to distract the underlying bone for cleaning, the clinician can activate the actuator 106 to compress the bones together and implant a permanent fixation. The clinician can turn the knob 126 to, for example, move the second engagement arm 104 toward the first engagement arm 102 until the end faces of the underlying bones contact one another and / or until a compressive force is applied to the end faces via the pins 112, 114. With the two end faces forced together via the compression distractor 100, the clinician can temporarily or permanently fix the bones or bone portions together. For example, one or more bone fixation devices can be applied to the two bones across the joint to stabilize the joint for fusion, such as two bone plates positioned in different planes. FIG. 16 illustrates an exemplary fixation device configuration including a first bone plate 310 positioned on the dorsal medial side of the first metatarsal and medial cuneiform, and a second bone plate 320 positioned on the medial plantar side of the first metatarsal and medial cuneiform. In other embodiments, the second bone plate 320 can be a spiral bone plate positioned on the plantar side of the first metatarsal across the joint space from the medial side of the cuneiform. The plate can be applied by inserting a bone screw. Examples of bone plates that can be used as the first bone plate 310 and / or the second bone plate 320 are described in U.S. Patent Publication No. US2016 / 0192970, filed January 7, 2016, entitled "Bone Plating System and Method," which is incorporated herein by reference. Other types of bone fixation device configurations can be used, and the disclosure is not limited in this respect.
[0091] As noted above, the compression distractor 100 can have a variety of different sizes, shapes, and configurations. Figures 17 and 18 are front perspective and side views, respectively, of the compression distractor 100 illustrating alternative configurations for the first and second engagement arms 102, 104. As shown in this example, the first and second pin blocks 134, 136 do not extend perpendicularly (e.g., at a 90-degree angle) from the remainder of the first and second engagement arms 102, 104, respectively. Rather, the proximal ends of the first and second engagement arms 102, 104 that extend away from the first and second pin blocks 134, 136, respectively, extend at a non-zero angle 140. Configuring the proximal ends of the first and second engagement arms 102, 104 at an angle away from their respective pin blocks can help position the arms out of sight of the pin blocks and correspondingly aid in surgical visibility, which can help remove the proximal ends of the first and second engagement arms 102, 104, including the actuator 106 carried by the proximal portions of the arms, from visually obstructing the site being treated.
[0092] 17 and 18, the proximal ends of first engagement arm 102 and second engagement arm 104 are shown angled upward, for example, relative to gravity and / or the surgical site where first pin block 134 and second pin block 136 will be positioned during use. In various examples, angle 140 can range from 1 degree to 90 degrees, e.g., 40 degrees to 80 degrees, or 50 degrees to 70 degrees. During use, the angled arms can position actuator 106 outward (e.g., inward) from the surgical site.
[0093] In addition to, or instead of, configuring the compression distractor 100 with angled engagement arms, the first pin block 134 and the second pin block 136 can be contoured for positioning on the bone being treated. As perhaps best illustrated in FIG. 18 , the distal end or bone-contacting portion 142 of each pin block can define a contoured end configured for positioning against a generally circular bone. The contoured surfaces can include a dorsal or upper wall surface 144 configured for positioning against a generally dorsal portion of the bone being treated, and a side wall surface 146 (e.g., a medial side wall surface) configured for positioning against a generally lateral portion of the bone being treated. In the illustrated example, the upper wall surface 144 is joined to the side wall surface 146 via a continuous radius of curvature, although the surfaces can be joined as intersecting wall segments with other radii of curvature or no joining radius of curvature. In either case, the top wall 144 and the side wall surface 146 may combine to define a pocket or cavity in which the bone is positioned during use of the compression distractor 100 .
[0094] Configuring one or both pin blocks of the compression distractor 100 with a pocket can be useful to provide a cutout opening on the open side of the pocket, which allows a clinician to visually observe the position of the pin block and / or bone during placement of the compression distractor 100. Additionally, the cutout opening can allow for placement of a bone fixation device, for example, while the compression distractor 100 remains attached to the bone being fixed by the pins.
[0095] FIG. 19 is a perspective view of a foot illustrating an exemplary deployment of a compression distractor 100 having a bone contacting portion 142 defining a notch. As shown in this example, the bone contacting portion 142 of the second pin block 136 is positioned over the medial cuneiform bone 222. The compression distractor 100, while still pinned to the medial cuneiform bone 222 and the first metatarsal bone 210, is raised dorsally from the bone surface. The notch defined by the bone contacting portion 142 provides a cavity into which a bone plate 310 can be inserted. When used in this manner, a bone plate (or other fixation element) can be attached across the joint (e.g., the tarsometatarsal joint) while the compression distractor 100 remains pinned to the metatarsal and cuneiform bones being treated. When used in this manner, the clinician may or may not provisionally fix the metatarsal to another bone (e.g., the opposing cuneiform) before permanent fixation.
[0096] Compression distractor devices and techniques are described. In some instances, the disclosed compression distractors are included in a disposable sterile kit that includes associated surgical instruments, such as the bone positioning guides and / or formation guides described herein. Other components that may be included in the sterile kit include bone fixation devices, bone fixation screws, pins for insertion into the pin-receiving holes, etc.
[0097] Various embodiments have been described. These and other embodiments are within the scope of the following claims. [Configuration 1] A compression-distraction device, a first engagement arm having a first pin-receiving hole for receiving a first pin inserted into the first bone portion; a second engagement arm having a second pin-receiving hole for receiving a second pin inserted into a second bone portion; an actuator operably coupled to the first engagement arm and the second engagement arm, the actuator configured to move the first and second engagement arms away from each other to move the first bone portion away from the second bone portion and to move the first and second engagement arms toward each other to move the first bone portion toward the second bone portion; A compression distractor, wherein the first pin receiving hole is angled relative to the second pin receiving hole at a non-zero degree angle. [Configuration 2] 2. The compression distractor of configuration 1, wherein the first pin receiving hole is angled relative to the second pin receiving hole in the frontal plane. [Configuration 3] 3. The compression distraction instrument of claim 2, wherein the first pin receiving hole is angled relative to the second pin receiving hole in the frontal plane at an angle ranging from 2 degrees to 20 degrees. [Configuration 4] 3. The compression distraction instrument of claim 2, wherein the first pin receiving hole is angled relative to the second pin receiving hole in the frontal plane at an angle ranging from 6 degrees to 15 degrees. [Configuration 5] 5. The compression distractor of any one of configurations 1-4, wherein the first pin receiving hole is angled relative to the second pin receiving hole in the sagittal plane. [Configuration 6] 6. The compression distractor of claim 5, wherein the first pin receiving hole is angled relative to the second pin receiving hole in the sagittal plane at an angle ranging from 5 degrees to 12 degrees. [Configuration 7] 6. The compression distractor of claim 5, wherein the first pin receiving hole is angled relative to the second pin receiving hole in the sagittal plane at an angle ranging from 7 degrees to 10 degrees. [Configuration 8] the first engagement arm further comprising a third pin-receiving hole; the second engagement arm further comprising a fourth pin-receiving hole; the first pin-receiving hole is angled relative to the second pin-receiving hole at a non-zero degree angle in a first plane; 8. The compression distractor of any one of configurations 1-7, wherein the first pin receiving hole is angled relative to the fourth pin receiving hole at a non-zero degree angle in the second plane. [Configuration 9] 9. The compression distractor of configuration 8, wherein the first plane and the second plane are sagittal planes in the coronal plane. [Configuration 10] A compression distractor as described in either of configurations 8 or 9, wherein the first pin receiving hole is parallel to the fourth pin receiving hole in the frontal plane and the second pin receiving hole is parallel to the third pin receiving hole in the frontal plane. [Configuration 11] 11. The compression-distraction instrument according to any one of configurations 1 to 10, wherein the actuator includes a shaft connected to the first engagement arm and the second engagement arm. [Configuration 12] 12. The compression distractor of claim 11, wherein the shaft is threaded and the actuator comprises a knob coupled to the shaft. [Configuration 13] 13. The compression distractor of any of configurations 11 or 12, wherein the actuator further comprises at least one unthreaded shaft extending parallel to the threaded shaft. [Configuration 14] the first engagement arm extends from a distal end to a proximal end, the threaded shaft is fixedly connected to the first engagement arm adjacent the proximal end, and the at least one unthreaded shaft is fixedly connected to the first engagement arm adjacent the proximal end; The compression distractor of configuration 13, wherein the second engagement arm extends from a distal end to a proximal end, and the at least one unthreaded shaft includes at least one unthreaded opening adjacent the proximal end through which it extends, and a threaded opening adjacent the proximal end through which the threaded shaft extends. [Configuration 15] the first engagement arm extends from a distal end to a proximal end; the second engagement arm extends from a distal end to a proximal end; the distal end of the first engagement arm defines a first pin block having a thickness greater than a remainder of the first engagement arm; 15. The compression distraction device of any one of configurations 1 to 14, wherein the distal end of the second engagement arm defines a second pin block having a thickness greater than the remainder of the second engagement arm. [Configuration 16] 16. The compression distractor of configuration 15, wherein the proximal end of the first engagement arm and the proximal end of the second engagement arm are angled upward at a non-zero degree angle from the first pin block and the second pin block, respectively. [Configuration 17] 17. The compression-extension instrument according to claim 16, wherein the non-zero angle is in the range of 40 degrees to 80 degrees. [Configuration 18] 18. The compression-distraction instrument of any one of configurations 15 to 17, wherein the first pin block and the second pin block each define a notch. [Configuration 19] 19. The compression distraction device of any one of configurations 1 to 18, wherein the first pin receiving hole and the second pin receiving hole each define a circular opening having a diameter in the range of 0.5 millimeters to 4 millimeters. [Configuration 20] 20. The compression-distraction device of any one of claims 1 to 19, wherein the actuator is configured to move the first engagement arm away from the second engagement arm a distance in the range of 1 millimeter to 2.5 millimeters. [Configuration 21] 1. A method comprising: inserting a first pin into a first bone portion and a second pin into a second bone portion such that the first pin is substantially parallel to the second pin; and inserting the compression distractor onto the first pin and the second pin by positioning at least the first pin through a first pin receiving hole of a first engagement arm of the compression distractor and the second pin through a second pin receiving hole of a second engagement arm of the compression distractor, wherein the compression distractor includes an actuator operably coupled to the first engagement arm and the second engagement arm. The method, wherein the first pin receiving hole is angled at a non-zero degree angle relative to the second pin receiving hole, such that inserting the compression distractor into the first pin and into the second pin moves the first bone portion relative to the second bone portion. [Configuration 22] and positioning a first fixation opening of an osteogenic guide over the first bone portion and a second fixation opening of the osteogenic guide over the second bone portion prior to inserting the first pin and the second pin, wherein the first and second fixation openings are parallel to each other; 22. The method of claim 21, wherein inserting the first pin and the second pin comprises inserting the first pin through the first fixation opening into the first bone portion and the second pin through the second fixation opening into the second bone portion. [Configuration 23] 23. The method of claim 22, further comprising, before inserting the compression distractor into the first pin and the second pin, leaving the first pin inserted in the first bone portion and the second pin inserted in the second bone portion and sliding the osteogenic guide off the first pin and the second pin. [Configuration 24] 24. The method of any of configurations 22 or 23, wherein the osteogenic guide includes at least one cutting slot, and further comprising cutting an end of the first bone portion through the at least one cutting slot and cutting an end of the second bone portion through the at least one cutting slot. [Configuration 25] 25. The method of any one of aspects 22-24, wherein the osteogenic guide includes at least one cutting slot, and further comprising, before sliding the osteogenic guide off the first pin and the second pin, cutting an end of the first bone portion through the at least one cutting slot and cutting an end of the second bone portion through the at least one cutting slot. [Configuration 26] 26. The method of any one of aspects 21 to 25, further comprising actuating the actuator on the distractor to move the first engagement arm away from the second engagement arm and then move the first bone portion away from the second bone portion. [Configuration 27] irrigating a space between the first bone portion and the second bone portion while the first engagement arm moves away from the second engagement arm; 27. The method of claim 26, further comprising: subsequently actuating the actuator on the compression distractor to move the first engagement arm toward the second engagement arm until the first bone portion is compressed relative to the second bone portion, and then moving the first bone portion toward the second bone portion. [Configuration 28] 28. The method of claim 27, further comprising securing the first bone portion to the second bone portion while the first engagement arm moves toward the second engagement arm to compress the first bone portion against the second bone portion. [Configuration 29] 29. The method of any one of aspects 21 to 28, wherein the first pin receiving hole is angled relative to the second pin receiving hole in the frontal plane, such that inserting the compression distractor into the first pin and into the second pin rotates the first bone portion relative to the second bone portion in the frontal plane. [Configuration 30] 30. The method of claim 29, wherein the first pin receiving hole is angled relative to the second pin receiving hole in the coronal plane at an angle in the range of 2 degrees to 20 degrees. [Configuration 31] 30. The method of claim 29, wherein the first pin receiving hole is angled relative to the second pin receiving hole in the coronal plane at an angle in the range of 6 degrees to 15 degrees. [Configuration 32] 32. The method of any one of aspects 21 to 31, wherein the first pin receiving hole is angled relative to the second pin receiving hole in the sagittal plane, such that inserting the compression distractor into the first pin and into the second pin rotates the first bone portion plantarly relative to the second bone portion in the sagittal plane. [Configuration 33] 33. The method of claim 32, wherein the first pin receiving hole is angled relative to the second pin receiving hole in the sagittal plane at an angle in the range of 5 degrees to 12 degrees. [Configuration 34] 33. The method of claim 32, wherein the first pin receiving hole is angled relative to the second pin receiving hole in the sagittal plane at an angle in the range of 7 degrees to 10 degrees. [Configuration 35] 35. The method of any one of aspects 21 to 34, wherein the first pin receiving hole is angled relative to the second pin receiving hole in at least two planes, such that inserting the compression distractor into the first pin and into the second pin moves the first bone portion relative to the second bone portion in at least two planes. [Configuration 36] 36. The method of claim 35, wherein the two planes include a frontal plane and a sagittal plane. [Configuration 37] 37. The method of any one of aspects 21-36, wherein the actuator comprises a threaded shaft movably connected to the first engagement arm and the second engagement arm. [Configuration 38] 38. The method of any one of aspects 21 to 37, wherein the first bone portion is a metatarsal bone and the second bone portion is a cuneiform bone. [Configuration 39] 39. The method of claim 38, wherein the metatarsal is a first metatarsal and the cuneiform is a medial cuneiform. [Configuration 40] A compression-distraction device, a first engagement arm having a first pin-receiving hole for receiving a first pin inserted into a first bone portion, the first engagement arm extending from a distal end to a proximal end, the distal end of the first engagement arm defining a first pin block having a thickness greater than a remainder of the first engagement arm; a second engagement arm having a second pin-receiving hole for receiving a second pin inserted into a second bone portion, the second engagement arm extending from a distal end to a proximal end, the distal end of the second engagement arm defining a second pin block having a thickness greater than a remainder of the second engagement arm; an actuator operably coupled to the first engagement arm and the second engagement arm, the actuator configured to move the first and second engagement arms away from each other to move the first bone portion away from the second bone portion and to move the first and second engagement arms toward each other to move the first bone portion toward the second bone portion; A compression distractor, wherein the proximal end of the first engagement arm and the proximal end of the second engagement arm are angled upward at a non-zero degree angle from the first pin block and the second pin block, respectively. [Configuration 41] 41. The compression-distraction instrument of claim 40, wherein the non-zero angle is in the range of 40 degrees to 80 degrees. [Configuration 42] 42. The compression distractor of any of configurations 40 or 41, wherein the first pin block and the second pin block each define a notch.
Claims
1. A compression-distraction device, a first engagement arm having a first pin-receiving hole for receiving a first pin inserted into a first bone portion, the first bone portion being a metatarsal; a second engagement arm having a second pin-receiving hole for receiving a second pin inserted into a second bone portion, the second bone portion being a cuneiform bone; an actuator operably coupled to the first engagement arm and the second engagement arm, the actuator configured to move the first and second engagement arms away from each other to move the first bone portion away from the second bone portion in a direction across the tarsometatarsal joint, and to move the first and second engagement arms toward each other to move the first bone portion toward the second bone portion in a direction across the tarsometatarsal joint, the actuator is positioned adjacent to a proximal end of each of the first and second engagement arms, and the first or second pin-receiving hole is positioned in the first or second engagement arm offset from the actuator; the first pin-receiving hole is angled relative to the second pin-receiving hole at a non-zero angle such that the compression distractor is configured to move the first bone portion relative to the second bone portion when the compression distractor is inserted over the first pin and the second pin; when the first pin inserted into the first bone portion is received in the first pin receiving hole and the second pin inserted into the second bone portion is received in the second pin receiving hole, the first pin receiving hole is angled relative to the second pin receiving hole in the frontal plane and / or the sagittal plane. Compression distractor.
2. 2. The compression distraction device of claim 1, wherein when the first pin inserted into the first bone portion is received in the first pin receiving hole and the second pin inserted into the second bone portion is received in the second pin receiving hole, the first pin receiving hole is angled relative to the second pin receiving hole in the frontal plane.
3. 3. The compression distractor of claim 2, wherein the first pin receiving hole is angled relative to the second pin receiving hole in the frontal plane at an angle ranging from 2 degrees to 20 degrees.
4. A compression distraction device as described in any one of claims 1 to 3, wherein when the first pin inserted into the first bone portion is received in the first pin receiving hole and the second pin inserted into the second bone portion is received in the second pin receiving hole, the first pin receiving hole is angled relative to the second pin receiving hole in the sagittal plane.
5. 5. The compression distractor of claim 4, wherein the first pin receiving hole is angled relative to the second pin receiving hole in the sagittal plane at an angle ranging from 5 degrees to 12 degrees.
6. the first engagement arm further comprising a third pin-receiving hole; the second engagement arm further comprising a fourth pin-receiving hole; when the first pin inserted into the first bone portion is received in the first pin receiving hole and the second pin inserted into the second bone portion is received in the second pin receiving hole, the first pin-receiving hole is angled relative to the second pin-receiving hole at a non-zero degree angle in the frontal plane; The compression distractor of any one of claims 1 to 5, wherein the first pin receiving hole is angled relative to the fourth pin receiving hole at a non-zero degree angle in the sagittal plane.
7. 7. The compression distractor of claim 6, wherein the first pin receiving hole is parallel to the fourth pin receiving hole in the frontal plane and the second pin receiving hole is parallel to the third pin receiving hole in the frontal plane.
8. The compression distractor of any one of claims 1 to 7, wherein the actuator comprises a shaft connected to the first engagement arm and the second engagement arm.
9. The compression distractor of claim 8 , wherein the shaft is threaded and the actuator includes a knob coupled to the shaft.
10. 10. The compression distractor of claim 8 or 9, wherein the actuator further comprises at least one unthreaded shaft extending parallel to the threaded shaft.
11. the threaded shaft is fixedly connected to a portion of the first engagement arm adjacent a proximal end of the first engagement arm, and the at least one unthreaded shaft is fixedly connected to a portion of the first engagement arm adjacent the proximal end of the first engagement arm; 11. The compression distractor of claim 10, wherein the second engagement arm includes at least one unthreaded opening adjacent the proximal end of the second engagement arm and a threaded opening adjacent the proximal end of the second engagement arm, the at least one unthreaded shaft extending through the at least one unthreaded opening and the threaded shaft extending through the threaded opening.
12. the first engagement arm extends from a distal end to a proximal end; the second engagement arm extends from a distal end to a proximal end; the first engagement arm includes a first pin block at the distal end thereof, the thickness of the first pin block being greater than the thickness of a portion of the first engagement arm other than the first pin block; A compression distraction instrument as described in any one of claims 1 to 11, wherein the second engagement arm includes a second pin block at its distal end, and the thickness of the second pin block is greater than the thickness of the portion of the second engagement arm other than the second pin block.
13. 13. The compression distractor of claim 12, wherein a portion of the first engagement arm other than the first pin block and a portion of the second engagement arm other than the second pin block are angled at a non-zero angle in the range of 40 degrees to 80 degrees from the first pin block and the second pin block, respectively.
14. 14. The compression distractor of claim 12, wherein the first pin block and the second pin block each define a notch, and the first pin block and the second pin block are positioned over the first bone portion and the second bone portion in corresponding notches.
15. 15. The compression distractor of claim 1, wherein the first pin receiving hole and the second pin receiving hole each define a circular opening having a diameter in the range of 0.5 millimeters to 4 millimeters.
16. 16. The compression distractor of claim 1, wherein the actuator is configured to move the first engagement arm away from the second engagement arm a distance in a range of 1 millimeter to 2.5 millimeters.
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