proximity devices

Abstract

Disclosed herein are methods and devices for approximating jaws and corresponding tissue segments. In some embodiments, the approximation device includes a first jaw attachable to a first jaw segment, a second jaw attachable to a second jaw segment smaller than the first jaw segment, and a housing. The second jaw is movably attached to the housing, and the second jaw is configured to move the second jaw segment toward the first jaw segment. The second jaw is configured to translate between a first position and a second position during a first segment of travel of the second jaw and to rotate at least between the second position and a third position during a second segment of travel.

Description

Technical Field

[0001] Related Applications This application was filed on April 13, 2020, claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Application No. 63 / 009,401, entitled "APPROXIMATION DEVICE", the entire content of which is hereby incorporated by reference herein.

[0002] Field The disclosed embodiments relate to devices for approaching segments and / or tissue portions, such as prior to a surgical procedure. Jaw

Background Art

[0003] Orofacial clefts, which are openings in either or both the gums and lips, are the most common congenital defects in infants. In addition to causing facial abnormalities, this disorder is associated with various other health problems, including feeding, hearing, and / or speech problems. Infants with orofacial cleft congenital defects typically undergo several reconstructive surgeries at an early stage, typically within 3 months after birth, to repair the defect as the infant's facial structure develops. Prior to the first surgery, the upper Jaw segment can be accessed.

Summary of the Invention

[0004] According to one embodiment, an approximation device includes a first Jaw jaw attachable to a first Jaw segment, a second Jaw jaw attachable to a second Jaw segment smaller than the first Jaw ​configured to move towards the segment. The second jaw is configured to translate between a first position and a second position during a first segment of the travel of the second jaw. The second jaw is configured to at least rotate between a second position and a third position during a second segment of the travel.

[0005] According to another embodiment, the approaching device comprises a first jaw attachable to a first Jaw segment, a second jaw attachable to a second Jaw segment, the second jaw being arranged to move towards the second Jaw segment, a housing to which the first jaw is fixedly attached and to which the second jaw is attached via a rocker arm, the rocker arm being movable relative to the housing. The rocker arm is Jaw configured to translate the second jaw from a first position to a second position therein and to at least rotate the second jaw from the second position to a third position during a second segment of the travel. First section of progress

[0006] According to another embodiment, a method of approaching a first, a second and Jaw a segment is disclosed via an approaching device having first and second jaws attached to a housing. The method comprises attaching a first jaw to a first Jaw segment, the first jaw being attached to the housing, attaching a second jaw to a second Jaw segment, the second jaw being movably attached to the housing, translating the second jaw relative to the housing to move the second jaw from a first position to a second position, and pivoting the second jaw relative to the housing to move the second jaw from the second position to a third position.

[0007] Since the present disclosure is not limited in this regard, it should be understood that the aforementioned concepts and the additional concepts described below can be arranged in any suitable combination. Furthermore, other advantages and novel features of the present disclosure will become apparent from the following detailed description of various non-limiting embodiments when considered in conjunction with the accompanying drawings.

Brief Description of the Drawings

[0008] Non-limiting embodiments of the present invention are described by way of example with reference to the accompanying drawings, which are schematic diagrams and are not intended to be drawn to scale. In the figures, each identical or substantially identical component shown is typically represented by a single number. For clarity, not all components are shown in all figures, and not all components of each embodiment of the present invention are shown if illustration is not necessary for those skilled in the art to understand the present invention. In the figures,

[0009]

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Mode for Carrying Out the Invention

[0010] Detailed Description Orofacial clefts are common congenital defects that exist as openings in either or both the gums and lips of infants. In addition to causing facial abnormalities, this defect can also cause other health problems such as feeding, hearing, and / or speech problems. Infants suffering from such orofacial clefts usually undergo several reconstructive surgeries at an early stage in an attempt to resolve the defect while their facial structures are still developing. For example, the cleft defect can be surgically repaired in the following three consecutive stages: (1) lip repair at approximately 3 months of age, (2) palate repair at approximately 9 months of age, and (3) alveolar repair at approximately 8 - 10 years of age.

[0011] Before the first surgery, the Jaw segment can be approached to reduce the tension near the defect in the infant's lip and nasal region. For example, a clinician can physically manipulate the Jaw cleft segment over several weeks or months to Jaw reposition the cleft segment and reduce the physical distance between the clefts. In some cases, Jaw by approaching the cleft segment, Jaw the tension on the cleft segment can be reduced, which may enable the clinician to more easily manipulate the segment during one of the surgical procedures. In some cases, a clinician can Jaw improve the infant's lip and reduce the risk of the lip cleft segment separating after surgery by approaching the segment. In some cases, Jaw the number of necessary surgical procedures can also be reduced by approaching the segment.

[0012] Various techniques can be used to approach the Jaw cleft segment before surgery. For example, a clinician can apply pressure through a lip segment by taping pieces to the infant's face to Jaw approach the cleft segment. Fixed and removable oral devices can also be used to Jaw approach the cleft segment. For example, an acrylic plate can be placed on the JawPressure can be applied by attaching to the segment and the segment can be moved and brought closer.

[0013] The inventor has recognized that existing approaching devices Jaw do not enable a clinician to control the way in which the fissure segments move towards each other. For example, some known devices pivot a first Jaw segment towards a second Jaw segment to move the first Jaw segment towards the second Jaw segment. As will be appreciated, the movement of such a device occurs in a similar manner, for example, by pivoting a portion of the device attached to the first Jaw segment. In some embodiments, Jaw the segments are pivoted towards each other regardless of the position of the first Jaw segment relative to the second segment and the device. This can cause the infant's Jaw to collapse and additional surgery may be required to correct it.

[0014] The inventor has also recognized that the use of existing devices is not easy. For example, existing devices typically require tools for attaching the device to the infant. The infant also needs to be anesthetized during the attachment of some known devices.

[0015] In view of the above, the inventor has recognized the advantages of an approaching device that enables a clinician to control the way in which the first and second jaws are moved together, such as before a surgical procedure. For example, in some embodiments, the clinician can translate the first Jaw segment (e.g., in the direction towards the second Jaw segment) before pivoting the first Jaw segment towards the second Jaw segment. In other embodiments, the clinician can Jaw move the first JawIt can be translated and pivoted simultaneously towards the segment. As will be appreciated, the device may, if desired, be the first Jaw used only to pivot the segment. In some embodiments, the inventor Jaw by controlling the movement of the segment, the device Jaw can maintain an upward force on the segment, which Jaw recognizes that the possibility of collapse can be minimized or even eliminated.

[0016] The inventor also recognizes the advantage of the device that it can be easily operated by a clinician and does not require the administration of general anesthesia. For example, in some embodiments, the device can be attached (e.g., by hand) without using additional tools. In such embodiments, the device can include a fastener (e.g., a pin) that can be inserted into the infant's Jaw segment when the clinician presses against the segment (e.g., by one or more fingers). Jaw segment.

[0017] Furthermore, the inventor recognizes the advantage of the device that the infant can tolerate it better after insertion. For example, the advantage can be realized if the device does not have the potential to interfere with the infant's feeding ability after insertion.

[0018] Embodiments of the present disclosure include an approaching device (referred to herein as a "device") arranged to move the first and second cleft segments together. According to aspects of the present disclosure, a clinician can operate the device to control the manner in which the first cleft segment moves towards the second cleft segment. The first and second cleft segments may include the first and second Jaw segments and / or the first and second lip segments.

[0019] In some embodiments, the device includes a first jaw attachable to a first fissure segment and a second jaw attachable to a second fissure segment. In some embodiments, the first fissure segment is larger than the second fissure segment and is referred to as the large fissure segment. In such embodiments, the second fissure segment is smaller than the first fissure segment and is referred to as the small fissure segment. In these embodiments, the first jaw of the device can be larger than the second jaw of the device. For example, the first larger jaw may be attachable to the large fissure segment, and the second smaller jaw may be attachable to the small fissure segment.

[0020] As will be appreciated, embodiments having fissure segments of similar size are also contemplated. In such embodiments, the jaws of the device can be configured to be of the same size such that each Jaw segment is attached to a jaw of the same size. In other embodiments, the larger and smaller jaws of the device can be attached to segments of similar size. Jaw

[0021] In some embodiments, the first and second jaws are attached to the housing. In some embodiments, each of the first and second jaws can be directly attached to the housing. In other embodiments, the second jaw can be attached to the housing via a rocker arm. In some embodiments, as described, the first jaw can be fixedly attached to the housing, while the second jaw is movably attached to the housing. In some embodiments, the rocker arm can be movably attached to the housing to drive the movement of the second jaw as described. As will be appreciated, in some embodiments, both the first and second jaws may be movably attached to the housing.

[0022] ​In some embodiments, the device is configured to enable a clinician to control at least the movement of a second jaw to move a second fissure segment toward a first fissure segment. For example, in some embodiments, actuating the device can move the second jaw between a first position and a second position. In some embodiments, the first position can include the position of the second jaw when the jaw is first attached to the housing and the device is attached to the infant's Jaw segment.

[0023] In some embodiments, the second jaw can translate from the first position to the second position. For the purposes herein, translating the jaw from the first position to the second position can include moving the second jaw linearly from the first position to the second position. For example, the jaw may move from a first position within the infant's mouth to a second position within the infant's mouth, and the second position is closer to the opening of the mouth (e.g., in a direction toward the infant's lips). In some embodiments, the second jaw can translate from the first position to the second position along a predetermined travel path. For example, the device can be arranged to translate the second jaw by a predetermined distance. In other embodiments, the device may enable a clinician to determine the extent (e.g., distance) by which the second jaw translates. For example, some infants may require the Jaw segment to translate a longer distance than other infants who require only a small amount of linear translation.

[0024] In some embodiments, the device can be operated to move a second jaw between a second position and a third position. In some embodiments, the second jaw can be rotated from the second position to the third position. For the purposes herein, rotating the jaw from the first position to the second position can include moving the second jaw in an arc around a pivot point from the second position to the third position. In some embodiments, the second jaw can rotate from the second position to the third position along a predefined travel path. For example, the device can be arranged to rotate the second jaw a predetermined distance along an arc. In other embodiments, the device may allow a clinician to determine the extent to which the second jaw rotates. For example, in some infants, Jaw the segment may need to rotate more than in other infants.

[0025] In some embodiments, the pivot point may be movable when the first jaw is translated between the first position and the second position. In some embodiments, the pivot point can be positioned closer to the back of the infant's mouth, such as when little or no translation is required. In other embodiments, the pivot point can be positioned closer to the center or even further forward of the infant's mouth, such as when a greater amount of linear translation is required.

[0026] As will be appreciated, in some embodiments, the device can be operated such that the second jaw simultaneously translates and rotates from the first position to the second position. For the purposes herein, simultaneously translating and rotating the jaw from the first position to the second position can include moving the second jaw in an arc around a pivot point from the first position to the second position while the pivot point moves linearly from the first position to the second position. Similarly to the above, the second jaw can translate and rotate along a predefined path from the first position to the second position. A clinician can also determine the extent to which the jaw rotates and / or translates.

[0027] As will be further appreciated, in still other embodiments, the clinicianJaw The rotation and translation of the segment can be combined or even alternated. For example, Jaw after the segment is moved (e.g., by rotation) from the second position to the third position, the clinician Jaw may move the segment from the third position to the fourth position. In some embodiments, the movement between the third position and the fourth position may include translation, translation and rotation, or simply more rotation, as needed by the infant.

[0028] Embodiments are shown and described in which a clinician (e.g., a doctor, nurse, surgeon, or other medical professional) activates the device to move the first Jaw segment towards the second Jaw segment, but the device may be used by other individuals in other embodiments. For example, the parent of an infant may be instructed on how to use the device. In some embodiments, the device may be activated by the parent at home under the instruction of the clinician after the clinician inserts the device.

[0029] In some embodiments, the device includes an actuator arranged to move at least a second jaw relative to the housing (and towards the first jaw). In some embodiments, the actuator is attached to the housing. In some embodiments, the actuator is at least partially disposed within the housing. In some embodiments, the actuator includes a first screw (e.g., a hex head screw) and a nut threadably engageable with the screw. In such embodiments, the second jaw may be connected to the nut. In some embodiments, the second jaw is attachable to the nut via a rocker arm (e.g., via a protrusion received in a corresponding channel). In some embodiments, as the clinician turns the screw (e.g., with a complementary tool), the nut moves along the length of the screw and the second jaw moves with the nut. In some embodiments, the nut is disposed within a channel formed in the housing, and the channel is arranged to maintain the position of the nut relative to the housing.

[0030] In some embodiments, a guide channel can be formed in the housing and a guide pin is formed on the rocker arm. In such embodiments, the channel can include first and second channel portions, and the guide pin moves between the channel portions as the second jaw translates and rotates. For example, in some embodiments, the second jaw can translate between a first position and a second position as the pin moves within the first channel portion. In some embodiments, the jaw can rotate between a second position and a third position as the pin moves within and along the second channel portion. In some embodiments, as the clinician rotates the screw, the pin can proceed from the first channel portion to the second channel portion.

[0031] In some embodiments, the actuator may include first and second screws each having a mating nut that travels along a corresponding screw length. In some embodiments, the second jaw may be attached to the first and second screws via a rocker arm. For example, the first and second nuts may each include first and second protrusions, each of which is received in a corresponding opening in the rocker arm. In some embodiments, the first pin may function as a pivot point about which the second jaw can rotate. In some embodiments, the second pin may guide movement of the second jaw together with a second opening.

[0032] In some embodiments, when the first screw is rotated, the first nut moves along the length of the first screw. Similarly, when the second screw is rotated, the second nut moves along the length of the second screw. In embodiments where the clinician rotates both screws, the rocker arm and the second jaw may translate linearly. In embodiments where the clinician rotates only one screw, the second jaw may rotate about the pivot point.

[0033] In some embodiments, the device further includes fasteners for attaching the first and second jaws to tissue, such as a cleft lip segment and / or Jaw a cleft segment. In some embodiments, the fasteners are attached without using tools.

[0034] In some embodiments, the device includes an audible click to alert the user (e.g., a clinician or parent) that one or both of the screws have been turned. In some embodiments, the screw may provide haptic feedback to the user (e.g., a clinician or parent) when turned a predetermined distance. For example, a clinician may instruct a parent to turn the lock "one click per day" after the infant has been sent home. In some embodiments, the device can include one or more locks to provide resistance to rearward resistance of the screw (e.g., forward slide or rearward rotation of the screw). For example, in some embodiments, the click may provide mechanical resistance to rearward rotation of the screw. In some embodiments, Jaw the segment may have a natural tendency to return to its original position (e.g., prior to linear translation or rotation), which may drive forward slide or rearward rotation of the screw.

[0035] Referring now to the figures, FIGS. 1 and 2 illustrate first and second Jaw embodiments of an approach device 100 attached to segments 102, 104 (see FIG. 1) and arranged to move a second Jaw segment 104 towards a first Jaw segment 102. As will be appreciated, movement of the first and second Jaw segments can cause movement of the first and second tissue portions (e.g., a first cleft lip segment and a second cleft lip segment) towards each other. In some embodiments, as shown in FIG. 1, the device 100 can be attached to a first Jaw segment 102 and a second Jaw segment 104 via first joe 110 and second joe 112, respectively. In some embodiments, the first Jaw segment 102 is larger than the second Jaw segment 104. As will be appreciated, the second Jaw segment 104 may also be larger than and / or of equal size to the first Jaw segment 102.

[0036] In some embodiments, the first jaw 110 and the second jaw 112 can be configured to conform to the first and second Jaw segments 102, 104. For example, a clinician can take an impression of each of the first and second Jaw segments 102, 104 and then use the impressions to shape the first jaw 110 to conform to the first Jaw segment 102 and to shape the second jaw 112 to conform to the second Jaw segment 104. As will be appreciated, in other embodiments, other manufacturing methods may be used to form the jaws. For example, a clinician can manufacture the first and second Jaw jaws 110, 112 to conform to the first and second segments 102, 104, respectively, by casting, milling, or any other suitable manufacturing method.

[0037] In some embodiments, the device includes fasteners for attaching the first and second jaws 110, 112 to a patient (e.g., an infant). For example, the first jaw 110 and the second jaw 112 can each include one or more fasteners 114 arranged to secure the jaws to their respective Jaw segments. FIG. 3 illustrates a device attachable to an infant. In some embodiments, the fasteners can include pins inserted into their respective Jaw segments. In some embodiments, as shown in FIG. 2, each jaw includes a JawIt may include two fasteners for attachment to the segment. Each joe may have only one fastener, or in other embodiments may have three or more fasteners. As will be understood, the number of fasteners need not be the same for each joe. For example, in some embodiments, the first (e.g., larger) joe may have more fasteners than the second (e.g., smaller) joe. The fasteners may be of the same shape and size in some embodiments, but in some embodiments, the shape and size may vary for each fastener. The fasteners are shown as pins in these figures, but it is understood that in other embodiments, the fasteners may have other suitable arrangements.

[0038] In some embodiments, the fasteners may be permanently attachable to each joe. The fasteners may also be removably attachable to each joe. For example, (e.g., Jaw by taking an impression of the segment) after the joe is formed, the fastener may be attachable to the joe for insertion into the infant. FIG. 19 shows an example of a fastener removed from a joe. As shown in this figure, the fastener can include a pin or stud having a head. As will be understood, the head is configured to receive finger pressure for inserting the distal end of the pin into the infant.

[0039] As shown in FIG. 20, the fastener 114 can be received in a fastener holder 148 that can be integrated within the first and / or second jaws 110, 112. In some examples, the fastener pin 146 can be inserted into a corresponding opening 150 of the fastener holder 148. In some embodiments, the holder includes a spring wire 152 arranged to hold the fastener within the fastener holder when a clinician inserts the pin 146 into the fastener holder. For example, as shown in FIG. 20, the proximal end of the pin (e.g., near or at the head of the pin) can include a locking region 154 arranged to contact the spring wire and expand outward when the clinician inserts the pin into the holder. As shown in FIG. 20, the diameter of at least a portion of the locking region is larger than the diameter of the pin in some embodiments. The locking region can be tapered or spherical, but may have other suitable arrangements. In some embodiments, when the fastener is fully seated within the holder 148 and the locking portion 154 moves through the spring wire 152, the spring wire can bounce back to a predetermined position and hold the fastener within the holder. As will be appreciated, the fastener may be held within the holder via other suitable arrangements. For example, the holder can hold the fastener via press fitting, friction fitting, or other suitable configurations.

[0040] At least as shown in FIG. 1, the first and second jaws 110, 112 are attachable to the housing 116. In some embodiments, the first and second jaws are removably attachable to the housing. For example, after the jaws are fabricated (e.g., via an impression of an infant), the jaws are attachable to the housing. As will be appreciated, the jaws Jaw can be removed from the housing after the segments are accessed and then discarded. In such embodiments, the housing may be configured to be reusable such that another set of jaws can be attached to the housing. As will be appreciated, the entire device can be discarded after access.

[0041] In some embodiments, the first and second jaws may be attached directly to the housing. In other embodiments, the jaws may be attached to the housing via one or more arms. For example, in some embodiments, as shown in FIGS. 1-3, the second jaw may be attached to the housing via a rocker arm 128. In some embodiments, one or both jaws may be movable relative to the housing. For example, in some embodiments, the second jaw 112 may be movably attached to the housing 116 via a rocker arm 128. In such embodiments, the first jaw 110 may be fixedly attached to the housing. For example, the first jaw may be attached to the housing via a fixed arm 126.

[0042] In some embodiments, as shown in FIG. 1, the first jaw 110 is attached to the first side of the housing 116, and the second jaw 112 is attached to the second, opposite side of the housing. In such embodiments, the larger jaw can be attached to the first side of the housing, while the smaller jaw can be attached to the second side of the housing.

[0043] As will be appreciated, during approach, the smaller Jaw segment may be movable towards the larger Jaw segment, but the smaller Jaw segment may be on either side of the infant's mouth. In some embodiments, the clinician may position the smaller jaw (e.g., jaw 112) such that the smaller JawRegardless of the position of the segment, the device and the jaws can be oriented so as to be movably attached to the housing. For example, in some embodiments, the housing can be inverted such that the rocker arm is located on a first side opposite that shown in FIG. 1. In such embodiments, the jaws can be attached to both sides of the housing and can be movable or fixed relative to the housing as desired. In such embodiments, a second jaw can be attachable to the first side, while a first jaw can be attachable to the second side.

[0044] According to aspects of the present disclosure, the device is arranged to selectively move the first and second Jaw segments towards each other. In some embodiments, the device is arranged to move a second Jaw segment towards a first Jaw segment. For example, in some embodiments, device 100 can, if desired, allow a clinician to selectively translate or pivot a second jaw 112 relative to a first jaw 110 (and / or relative to the housing), moving the second Jaw segment translationally and / or rotationally relative to the first Jaw segment.

[0045] FIGS. 5-7 show the first and second JawIllustrate an exemplary path of the second jaw approaching the first jaw. In FIG. 5, the second jaw 112 is shown in the first position. In some embodiments, the first position may be the starting position of the second jaw. In some embodiments, the starting position may include the position of the second jaw when the second jaw is first attached to the housing and the device is attached to the infant. As shown in FIG. 5, in some embodiments, when the second jaw 112 is in the starting position, the rocker arm 128 may be located at or near the first end 113 of the housing. As understood, when the device is inserted into the infant's mouth, the first end of the housing may be positioned at or near the center or the back of the infant's mouth. For example, the first end of the housing may be located further away from the opening of the infant's mouth compared to the second opposite end 115 of the housing. In some embodiments, at the starting position, the rocker arm extends substantially perpendicular to the longitudinal axis of the housing. In some embodiments, the rocker arm extends substantially perpendicular to the longitudinal axes of one or more screws 108, 106 within the housing.

[0046] FIG. 6 shows the device with the second jaw 112 in the second position. In some embodiments, as shown in this figure, the second jaw is translated from the first position (see FIG. 5) to this second position. For example, the jaw may be moved linearly away from the first end 113 of the housing. In an exemplary example, the jaw has moved a distance D from the first end 113 of the housing. As understood, the movement of the jaw away from the first end of the housing includes moving the jaw towards the front of the infant's mouth.

[0047] In some embodiments, the distance D that the second jaw moves from the first position to the second position may be selected by the clinician. For example, in some embodiments, the clinician may cause the jaw to progress a desired amount (and corresponding JawThe device can be selectively actuated until the crack segment moves). In other embodiments, the distance that the second jaw moves from the first position to the second position is predetermined. For example, the jaw can move a predetermined distance from the first end of the housing before it can move in another direction (e.g., by rotation).

[0048] FIG. 7 shows the device with the jaw in the third position. In some embodiments, the jaw is rotated about the pivot point P (see the arrow labeled R in FIG. 6) (see FIG. 6). As shown in FIG. 6, the jaw can rotate in a direction towards the housing and / or towards the first jaw. Similarly, in some embodiments, the device can be arranged such that a clinician can determine the degree to which the second jaw rotates relative to the housing (and the first jaw). In other embodiments, as described, the degree of rotation can be preset by the device. For example, in some embodiments, the device rotates the second jaw along a predetermined path.

[0049] The device is shown to translate the second jaw relative to the housing (and / or the first jaw) in some steps and rotate the second jaw relative to the housing (and / or the first jaw) in some steps, but the device may be arranged such that the second jaw can be translated and rotated simultaneously. In such embodiments, the second jaw can rotate towards the first jaw as the second jaw translates (and the pivot point moves away from the first end of the housing).

[0050] As will be appreciated, only the second jaw is shown to be movable relative to the housing (and the first jaw), but in other embodiments, only the first jaw may be movable relative to the housing (and the second jaw). In still other embodiments, both the first and second jaws may be movable relative to the housing and to each other.

[0051] In some embodiments, the device includes an actuator arranged to move at least a second jaw 112 relative to the housing 116 (and the first jaw 110). In some embodiments, the actuator is attached to the housing. In some embodiments, the actuator may be at least partially disposed within the housing. In some embodiments, the housing includes a body 119 and a cover 121. In some embodiments, the cover is fixedly attached to the body (see, for example, FIG. 4). In some embodiments, the cover includes a cover plate.

[0052] In some embodiments, as shown at least in FIGS. 1 and 4 - 7, the actuator includes first and second screws 106, 108 and corresponding first and second nuts 122, 124, each arranged to drive the movement of the second jaw (e.g., via a rocker arm). For example, the actuator may include first and second hex head screws that can be actuated by a clinician to drive the movement of the jaw. As shown in FIG. 4, each nut is threaded onto its respective screw and arranged to move along the length of the screw as the clinician turns the screw.

[0053] In some embodiments, each of the first and second screws 106, 108 is disposed within the housing. For example, as shown in FIG. 4, each screw may extend within respective channels 123, 125 formed within the body of the housing. In some embodiments, each channel is substantially rectangular in shape. As shown in this figure, each screw can extend through first and second openings of the housing, the openings being adjacent to the channels. In some embodiments, each of the first openings is formed in the wall of the first end of the housing, and each of the second openings is located in the wall of the second end of the housing.

[0054] As shown in FIG. 4, each nut can also be disposed within channels 123, 125 of the housing. In some embodiments, the width of the channel corresponds to the width of the nut. In some embodiments, the channels are arranged to minimize or even prevent lateral movement of the jaws. For example, in some embodiments, the nut can move linearly within the channel (e.g., between a first position and a second position), but can be made not to move laterally or to move minimally laterally. The channels can also be arranged so that the nut does not rotate when the clinician turns one or both of the screws.

[0055] As shown in FIG. 8, the rocker arm can be attachable to the first and second screws and can cooperate with the first and second screws to drive the movement of the second jaw. For example, in some embodiments, the first and second nuts 122, 124 are each configured to interact with the rocker arm 128. In some embodiments, the first nut 122 includes a first protrusion 130 configured to fit within a first opening 131 within the rocker arm 128. In some embodiments, the shape of the first opening 131 corresponds to the shape of the protrusion 130 on the first nut 122. For example, the first protrusion and opening can each be circular in shape. As will be appreciated, the protrusion and opening can have other suitable shapes such as square, oval, triangular, other polygonal or other shapes. In some embodiments, the first protrusion 130 forms a pivot point about which the rocker arm 128 (and the second jaw) can rotate.

[0056] In some embodiments, the second nut 124 has a second protrusion 132 configured to fit into a second opening 133 of the rocker arm 128. In some embodiments, the second opening 133 includes an elongated opening within which the second protrusion is movable while the second joe pivots. For example, the second protrusion can move within the second opening when the rocker arm pivots about pivot point P to rotate the second joe. In some embodiments, the second channel can serve as a guide channel for guiding the movement of the second joe. For example, in some embodiments, the second opening is arranged to control the degree to which the second joe rotates. For example, when the second protrusion hits one of the ends of the second opening, the second joe can no longer rotate.

[0057] In some embodiments, the rocker arm is sandwiched between the cover and the first and second nuts, and the first and second protrusions are received in the first and second openings of the rocker arm.

[0058] As shown in FIG. 5, when the second joe is in the first position, the first and second nuts are positioned at the first end 113 of the housing 116. As will be appreciated, the first and second nuts can be located near the first end, or even at a distance from the first end, in the first position, in other embodiments. To move the second joe 112 relative to the housing and the first joe 110, the clinician can first turn the first and / or second screws 106, 108 to move the first and / or second nuts away from the first end of the housing. In some embodiments, the first nut 122 is configured to travel a length proportional to the distance the first screw 106 is turned. Similarly, the second nut 124 can be configured to travel a length proportional to the distance the second hex screw 108 is turned.

[0059] In some embodiments, when the first and second screws 108 are rotated in the same direction at the same speed, the first nut and the second nut each travel the same distance along the length of each of the first and second screws. The rocker arm 128 and the second jaw move away from the first end of the housing together with the first and second nuts. FIG. 6 shows the device 100 in a state where the second jaw 112 is in the second position after the second jaw has moved away from the first end of the housing and has translated linearly toward the first jaw 110 (distance D).

[0060] In embodiments where the clinician rotates the first screw 106 or the second screw 108 individually, only the first nut or the second nut moves along the length of the corresponding screw (e.g., away from the first end of the housing). In such embodiments, the second protrusion on the second nut moves within the second opening of the rocker arm, and the rocker arm can pivot about the pivot axis P. Thereby, further, the second jaw can be pivoted toward the first jaw.

[0061] As will be appreciated, in some embodiments, the clinician may pivot and translate the second jaw simultaneously. For example, in some embodiments, the clinician may rotate the first and second screws simultaneously but at different speeds. In such embodiments, the second jaw can pivot about the pivot axis while the pivot axis translates linearly away from the first end of the housing.

[0062] FIGS. 2 and 9-13 illustrate another arrangement of the actuator of the access device. As shown in these figures, the actuator can, as in this case as well, have screws and nuts arranged to drive the movement of the second jaw. For example, as above, the nut can be threadably engaged with the screw and arranged to move along the length of the screw as the clinician rotates the screw. As above, the nut can include a protrusion 132 received within the elongated channel 133 of the rocker arm (see FIG. 10). When the rocker arm pivots, the protrusion can move within the channel.

[0063] In some embodiments, as shown in FIGS. 9 and 10, the rocker arm may include a guide pin 135 received in a guide channel 134 formed in the cover 121 of the housing. In some embodiments, the guide channel is arranged to guide the movement of the second jaw. For example, in some embodiments, the guide channel is arranged to guide the second jaw along a predetermined path. In some embodiments, as shown in FIG. 10, the channel may include a first channel portion 136 and a second channel portion 138. In some embodiments, as shown in FIG. 10, the first channel portion is substantially parallel to the longitudinal axis of the cover plate. In some embodiments, the second channel portion is angled with respect to the first channel portion. The second channel portion may be curved.

[0064] In some embodiments, when the clinician turns the first screw 106, the guide pin of the rocker arm 128 travels along the first channel portion 136 such that the nut, rocker arm, and second jaw translate linearly in a direction away from the first end of the housing. In such embodiments, when the pin travels a predetermined distance, the guide pin can enter the second channel portion and the rocker arm can rotate as the clinician turns the first screw 106.

[0065] In some embodiments, the width of the channel also corresponds to the width of the guide pin to minimize or even prevent unwanted lateral movement of the jaw relative to the housing as the jaw translates.

[0066] Figures 11-13 illustrate the movement of the second jaw 112 when the clinician rotates the screw (e.g., between the first position and the second position and then between the second position and the third position). FIG. 11 shows the device in the first position. FIG. 12 shows the device after the clinician turns the screw 106 and the second jaw 112 has moved linearly away from the first end 113 of the housing to the second position. FIG. 13 shows the device after the second jaw 112 has rotated from the second position to the third position about the pivot point P (see FIG. 10).

[0067] Figures 14-17 illustrate another arrangement of the actuator of the access device. Similar to the above and as shown in these figures, the access device may include a screw that can be turned by the clinician to drive the movement of the second jaw (e.g., via the rocker arm 128). In some embodiments, the driver arm 140 is threadable onto the screw and is arranged to travel along the length of the screw as the screw is turned. In some embodiments, the movement of the driver arm pushes the rocker arm, thereby causing the second jaw 112 to move relative to the housing.

[0068] Similar to the above, a guide channel 134 may be formed within the housing to guide the movement of the second jaw. As shown in FIG. 15, the guide channel can be formed within the body of the housing, although the guide channel may be formed in another suitable portion of the housing (e.g., within a cover). In some embodiments, the guide channel has first and second channel portions 136, 138. In some embodiments, the second channel portion is located at the distal end of the first channel portion. In some embodiments, the width of the channel corresponds to the width of the guide pin 135 on the rocker arm such that lateral movement of the rocker arm (and the jaw) can be minimized and / or prevented. In some embodiments, the second channel portion is wider than the first channel portion such that the guide pin can rotate freely within the second channel portion.

[0069] As can be understood in view of the above, when the clinician turns the screw and the guide pin is located in the first channel portion, the rocker arm 128 can translate in a direction away from the first end 112 of the housing. FIG. 16 shows the rocker arm after linear translation. When the guide pin reaches the second channel portion, the guide pin can rotate, pivoting the rocker arm (and the second jaw) about the pivot axis. FIG. 17 shows the third position of the rocker arm (and the second jaw) after pivoting. As described above, the guide pin can, in some embodiments, define the pivot axis (see FIG. 16). In some embodiments, the drive arm can also stop the rearward movement of the second arm after rotation is complete.

[0070] Embodiments are shown and described as using hex head screws, but in other embodiments, the screws may have other suitable arrangements. For example, screws 106 and 108 can be plus screws, minus screws, square head screws, Torx screws, or any other suitable configuration. As will be understood, other suitable actuators for translating and / or rotating the second jaw can be used in other embodiments.

[0071] In some embodiments, as shown in FIG. 18, the device 100 can include a lock 144 that can be configured to prevent rearward movement of the jaw (e.g., to a second, first, or other position). In some embodiments, the lock 144 can prevent the screw 106 from turning in a direction opposite to the direction in which it is used to move the nut away from the first side of the housing.

[0072] In some embodiments, the lock is spring-biased to a locked position (see FIG. 18). In some embodiments, the spring can be a leaf spring, a coil spring, a bow spring, or any other suitable configuration. In some embodiments, the lock is disposed to contact a knob attached to the screw (e.g., via contact surface 145). In some embodiments, when the clinician turns the screw, the knob can spread the lock outward. When the engagement surface 147 of the knob moves past the lock, the lock can snap back to the locked position. In some embodiments, the lock is arranged to produce an audible click that warns the user (e.g., the clinician or parent) that the screw has made a full rotation.

[0073] In some embodiments, the present disclosure can be embodied as a method of accessing a Jaw segment and / or tissue portion, the steps of which are outlined in FIG. 21. In some embodiments, the method includes attaching a first joe 110 to a Jaw segment. The clinician can then attach a second joe 112 to a second Jaw segment. The clinician can then activate the device to translate the second joe 112 from a first position to a second position. The clinician can then activate the device to rotate the second joe 112 from the second position to a third position. As will be appreciated, the steps of translating and / or rotating can be performed using one of the actuators described above. In some embodiments, some of the steps can be performed simultaneously. For example, in some embodiments, the second joe can be rotated and translated simultaneously. In some embodiments, after the method of accessing, a surgical procedure can be performed, whereby tissue portions (e.g., cleft lip portions) associated with the first and second Jaw segments can be attached to each other.

[0074] The device is shown and described as being used with infants to repair cleft defects, but the device can be used with pediatric and / or adult tissues and / or JawIt can be used to bring segments closer.

[0075] As will be further understood, although the device is described as being used before a surgical procedure, in some embodiments, it is understood that the device can be used during a surgical procedure.

[0076] The various aspects of the present disclosure may be used alone, in combination, or in various arrangements not specifically described in the foregoing embodiments. Thus, its application is not limited to the details and arrangements of the components described or illustrated in the foregoing description. For example, the aspects described in one embodiment may be combined with the aspects described in other embodiments in any manner.

[0077] Also, the present invention can be embodied as the method for which examples are provided. The operations performed as part of this method may be ordered in any suitable way. Thus, embodiments may be constructed in which the operations are performed in an order different from that illustrated, which may include performing some operations simultaneously, even if in the exemplary embodiments they are shown as sequential operations.

[0078] The use of terms indicating order such as "first," "second," "third," etc. in the claims to modify elements of the claims does not in itself imply any priority, precedence, or order of one element of a claim over another element, or the temporal order in which the acts of a method are performed, but is solely used as a notation for distinguishing one element of a claim having a particular name from another element having the same name (merely due to the use of terms indicating order).

[0079] Also, the terms and technical terms used in this specification are for the purpose of explanation and should not be regarded as limiting. The use of "including", "comprising", "having", "containing", "involving", and variations thereof in this specification means including the items listed thereafter and their equivalents, as well as additional items.

Claims

1. a first jaw attachable to a first jaw segment, a second jaw attachable to a second jaw segment smaller than the first jaw segment, a housing, and comprising, wherein the second jaw is movably attached to the housing, and the second jaw is configured to move the second jaw segment towards the first jaw segment, wherein the second jaw is configured to translate between a first position and a second position during a first section of the progression of the second jaw, wherein the second jaw is configured to rotate at least between the second position and a third position during a second section of the progression, an approaching device.

2. The device according to claim 1, wherein the first jaw is fixedly attached to the housing.

3. The device according to claim 1, wherein the second jaw is attached to the housing via a rocker arm, and the rocker arm is movably attached to the housing.

4. The device according to claim 3, wherein the second jaw is fixedly attached to the rocker arm.

5. The device according to claim 3, further comprising an actuator arranged to move the second jaw from the first position to the second position and from the second position to the third position.

6. wherein the actuator comprises a first screw, a first nut threadable onto the first screw and arranged to travel along the length of the first screw, and including, wherein the first nut is connected to the rocker arm, the device according to claim 1.

7. The device according to claim 1, wherein the first nut includes a first protrusion received in a first opening of the rocker arm.

8. wherein the actuator further comprises a second screw, a second nut threadable onto the second screw and arranged to travel along the length of the second screw, and further including, wherein the second nut is connected to the rocker arm, the device according to claim 7.

9. The device according to claim 8, wherein the second nut includes a second protrusion received in a second opening within the rocker arm.

10. The device according to claim 5, wherein the actuator is at least partially disposed within the housing.

11. The device according to claim 6, wherein the rocker arm includes a guide pin, and the guide pin is received in a channel formed in one of the cover and the body of the housing.

12. The device according to claim 1, wherein each of the first and the jaws includes one or more fasteners arranged to attach the jaw to the respective jaw segment.

13. The device according to claim 12, wherein the one or more fasteners are removably attachable to the respective jaws.

14. A first jaw attachable to a first jaw segment, A second jaw attachable to a second jaw segment, the second jaw being arranged to move the second jaw segment towards the first jaw segment, A housing, wherein the first jaw is fixedly attached to the housing, the second jaw is attached to the housing via a rocker arm, and the rocker arm is movable relative to the housing, Comprising, The rocker arm is configured to translate the second jaw from a first position to a second position during a first section of the travel of the second jaw, and to at least rotate the second jaw from the second position to a third position during a second section of the travel, Approaching device.

15. The device according to claim 14, wherein the second jaw is fixedly attached to the rocker arm.

16. The device according to claim 14, further comprising an actuator arranged to move the second jaw from the first position to the second position and from the second position to the third position.

17. The actuator is A first screw, A first nut threadably engageable with the first screw and arranged to travel along the length of the first screw, The device according to claim 16, wherein the rocker arm is connected to the first nut.

18. The actuator is A second screw, A second nut threadably engageable with the second screw and arranged to travel along the length of the second screw, The device according to claim 17, including and the rocker arm being connected to the second nut.

19. The device according to claim 17, wherein the rocker arm includes a guide pin received in a guide channel within the housing.

20. The device according to claim 14, wherein the rocker arm is at least partially disposed within the housing.

21. A method of approaching first and second jaw segments via a proximity device having first and second jaws attached to a housing, the method including the following steps: Attaching a first jaw to a first jaw segment, the first jaw being attached to the housing; Attaching a second jaw to a second jaw segment, the second jaw being movably attached to the housing; Translating the second jaw relative to the housing to move the second jaw from a first position to a second position; and Pivoting the second jaw relative to the housing to move the second jaw from the second position to a third position.

22. The method according to claim 21, wherein the pivoting step is performed after the translating step.

23. The method according to claim 21, further including forming the first and second jaws prior to the step of attaching the first and second jaws.

24. The method according to claim 21, wherein the translating step includes linearly moving the second jaw in a direction away from a first side of the housing.

25. Before the translating step, the method further includes operating the device, the operating step including: Rotating a first screw; and Moving a first nut along a first length of the first screw, the second jaw being attached to the first nut via a rocker arm. The method according to claim 21.

26. Before the pivoting step, the method according to claim 25 further includes rotating the first screw and moving the first nut along a second length of the first screw.

27. The method according to claim 26, further including pivoting the rocker arm relative to the housing.

28. The method according to claim 27, wherein the step of pivoting the rocker arm includes moving a protrusion of the rocker arm within a channel formed in the housing.

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