Palatal insertion plate and its manufacturing method
The palatal insertion plate with wings and webs corrects vomer curvature by securing to the palate and applying therapeutic force, addressing respiratory issues in infants with cleft lip and palate through sequential treatment.
Patent Information
- Application Number
- JP2022535612
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2019-12-13
- Filing Date
- 2020-12-09
- Publication Date
- 2025-11-25
- Estimated Expiration
- 2040-12-09
Smart Images

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Abstract
Description
[Technical Field]
[0001] The subject of the present application is a palatal insert plate having the features of the preamble of claim 1, a set of plates according to claim 12 and a method for manufacturing a palatal insert plate according to claim 14. [Background technology]
[0002] It is known that cleft lip and palate usually results from an improperly developed or improperly positioned premaxilla. As is well known, in this case, the vomer also exists in a crooked or twisted state. If such developmental or malpositional abnormalities in cleft lip and palate are left untreated, it can lead to nasal airway obstruction, meaning that the affected person may only breathe on one side, live with severe breathing problems, or need to undergo surgery to correct nasal dysfunction.
[0003] Cleft lip and palate typically exists when there is a continuous cleft in the upper lip, maxilla, and palate. However, in this application, the term cleft lip and palate will also be used to refer to forms of cleft in which only one or two of these structures are affected. Examples of this include cleft lip, cleft lip and palate, or cleft palate.
[0004] Devices and methods for treating misalignments that occur in cleft lip and palate are known in the art. These procedures aim to reposition or displace the premaxilla and vomer of an infant with a cleft lip and palate using a palatal plate without surgery during the first few days of the infant's life. Typically, such treatment with a palatal plate is performed during the first few days of the infant's life because, after just a few days of life, an infant's maxilla begins to fuse, making it nearly impossible to displace the premaxilla and vomer with a palatal plate after just a few weeks of life.
[0005] Such removable palatal plates are known, for example, from Hotz (Non-Patent Document 1). This custom-made plate can be placed in the infant's oral cavity for the first few days of life to control the growth of the maxillary bone segments. When the Hotz plate is inserted, the infant's mandible is displaced from its resting position, resulting in a therapeutic muscle imbalance. Growth stimulation or growth blockage can be stimulated in a targeted manner depending on the plate design.
[0006] Another example known from the prior art is the nasoalveolar molding (NAM) technique by Grayson (Non-Patent Document 2). In this method, a removable palatal plate is custom-made based on an impression of the infant's maxilla. By inserting the NAM palatal plate into the infant's oral cavity, the displacement of the premaxilla is reduced by the application of force. In addition, the Grayson palatal plate has a support protruding outside the mouth, which allows for correction of nasal cartilage deformities in addition to correction of the premaxilla. This allows for additional curvature of the vomer. However, treatment with the NAM palatal plate does not allow for correction or correction of the vomer shape.
[0007] However, although it has been shown that treatment with known palatal plates can indeed reduce premaxillary deviation in infants with cleft lip and palate, correction of the vomer or avoidance of vomer bowing has not been achieved, or at least not always satisfactorily. [Prior art documents] [Non-patent literature]
[0008] [Non-Patent Document 1] T. Fuchigami et al., "Comparison of short-term effects of presurgical nasoalveolar molding and Hotz's plate on maxillary arch form in unilateral cleft lip and palate," Journal of Oral and Maxillofacial Surgery, Medicine, and Pathology, Vol. 31, January 1, 2019, pp. 25-30 [Non-patent document 2] Grayson BH, "Shetye PR, Presurgical nasoalveolar molding treatment in cleft lip and palate patients", Indian J Plast. Surg., October 2009, Special Issue 42, pp. 56-61 Summary of the Invention [Problem to be solved by the invention]
[0009] Therefore, it is an object of the present invention to develop an orthodontic device for treating cleft lip and palate that can improve the quality of life of patients. [Means for solving the problem]
[0010] This object is achieved by a palatal insertion plate according to the independent claims and by a method for manufacturing a palatal insertion plate and by a set of plates for the progressive correction of the vomer in infants with cleft lip and palate. Particular embodiments are described in the description, the subclaims and the figures.
[0011] The plates proposed herein for palatal insertion have wings on either side of an imaginary central plane perpendicular to the plate, and these wings are designed so that they abut the palate in at least some area. The wings allow the plate to be inserted into a specific position in the palate of an infant. In addition, the wings of the proposed plates promote a tight fit of the plate on the palate of an infant when the plate is inserted into the palate.
[0012] Furthermore, the plate proposed herein comprises at least two webs extending over at least a portion of either side of the central surface, thereby forming a free space extending between the webs for receiving the vomer.
[0013] The proposed plate for palatal insertion herein is based on the insight that by correcting a curved vomer or avoiding curvature of a non-curved vomer when treating cleft lip and palate with a palatal plate, consequential damage can be prevented and the patient's respiratory difficulties in the nasal region can be significantly reduced.
[0014] The at least two webs of the proposed plate extend at least partially on both sides of the central plane to form a free space between them for receiving the vomer. When the plate is inserted into the palate, the vomer is received in the free space and sandwiched between the two webs. The shape of the plate is adapted to the infant's palate so that the plate is supported on the palate, particularly by the wings, and is fixed relative to the palate in multiple directions. For example, these multiple directions may include at least one direction along the central plane of the plate and at least one direction transverse to the central plane. The free space defines a displacement in the path of the vomer and is suitable for receiving the vomer. The central plane of the plate may coincide with the sagittal plane of the palate when the plate is inserted into the palate. Due to the stable fit of the plate on the palate and the offset of the web path relative to the current path of the vomer, a new path can be created by the therapeutic force. The therapeutic force is considered to be the force exerted by the proposed plate on components of the infant's palate, such as the vomer or maxilla, or both, when the plate is inserted into the infant's palate.
[0015] During treatment with the proposed plate, the path of the vomer can be changed by a treatment force. When the plate is inserted into the palate of an infant, the path of the plate's web deviates from the path of the vomer at least in part, and the web displaces the vomer in at least some areas, i.e., the treatment force. For example, the path of the vomer can be displaced if the free space on a first side of the vomer transverse to the central plane is smaller than the free space on the side of the vomer opposite the first side transverse to the central plane. As a result, when the plate is inserted into the palate of an infant, the vomer is pushed, i.e., displaced, toward the side of the vomer with more free space. In particular, a displacement of the path of the vomer can be achieved, in which free space is formed only in at least some areas on the second side of the vomer transverse to the central plane. The web can have a curvature that matches the vomer. The curvature of the webs may be less pronounced compared to, for example, the curvature of the vomer. A particular advantage results from the fact that the webs can reduce the curvature of the vomer through a therapeutic force. The direction of the therapeutic force can be selected through the shape and arrangement of the webs so that the individual deviations of the vomer can be specifically reduced and additionally or alternatively corrected. As a result, the proposed plate allows a targeted change in the path of the vomer and a targeted correction of a curved vomer.
[0016] The webs of the proposed plate can be designed to extend linearly along the central plane, in addition to or instead of extending next to each other along the central plane. Webs extending linearly next to each other, in addition to or instead of extending along the central plane, are particularly advantageous when applying a therapeutic force to the vomer until the path of the vomer coincides with the path of the free space extending between the webs.
[0017] An initial state of the vomer path and, in addition to or instead, a desired final state of the vomer path may be defined, providing that the vomer path is gradually altered by successive treatments with the multiple proposed plates. The initial state of the vomer path may correspond to the initial vomer path of an infant with cleft lip and palate before treatment with the multiple proposed plates. The free space of a first plate of the multiple proposed plates defined by the web path can result in a first displacement of the initial vomer path when the first plate is inserted into the infant's palate. The web path of the first plate has a first offset relative to the initial vomer path. After the web path of the first plate is pressed against the vomer path, the first plate of the multiple proposed plates can be replaced with a second plate of the multiple proposed plates. A second plate of the proposed plurality of plates can cause a second displacement of the vomer path through the free space defined by the web path of the second plate when the second plate is inserted into the palate of an infant. The web path of the second plate has a second offset relative to the initial vomer path, the second offset being greater than the first offset. The second plate can also be replaced with a plate having a further displacement of the vomer path. The plates can be successively replaced until the last plate of the proposed plurality of plates is inserted, the last plate of the proposed plurality of plates having a web path that matches the desired final state of the vomer path, thereby providing the desired final state of the vomer path with the last plate. By gradually changing the vomer path with each plate, smaller vomer displacement can be achieved, and therefore, the infant's pain can be alleviated with each treatment using each plate. In addition, the displacement of the vomer path possible with only one plate is limited to a maximum displacement. Sequential treatment with multiple plates can overcome the maximum displacement of a single plate and achieve a greater total displacement.
[0018] Additionally, the vomer path can be maintained by a web path that conforms to the vomer path, which is useful, for example, when the vomer path is already in a desired shape and should be maintained in this shape.
[0019] The wings of the proposed plate, extending on both sides of an imaginary central plane perpendicular to the plate, are configured to abut the palate in at least some areas and can be specifically designed to fix the plate to the palate of an infant. The shape of the wings allows the wings, with their upper surfaces, to conform to the palate of an infant in at least some areas. Preferably, the wings can be designed to contact the lateral maxillary segments of an infant during insertion of the plate into the palate. That is, the upper surfaces of the wings can be configured to contact the mandibular, or caudal, surface of the lateral maxillary segments and the maxillary, or cranial, surface of the lateral maxillary segments. Furthermore, the upper surfaces of the wings, in addition to or instead of, the shape of the wings can be designed to fit, preferably precisely, to the surfaces of the maxillary segments. This has the advantage that the retention of the plate on the infant's maxilla during insertion can be supported, and the appropriate shape of the wings improves the wearing comfort of the infant.
[0020] Typically, the plate is made in one piece and may additionally or alternatively be made of plastic, examples being polyetheretherketone (PEEK) or synthetic resin. In one embodiment, the plate can have a receiving portion for receiving the premaxilla, the receiving portion including at least one bowl-shaped recess. The receiving portion can preferably receive the premaxilla of the infant and function to reduce displacement of the premaxilla of the infant. The bowl-shaped recess is designed so that the premaxilla of the infant is positioned in the bowl-shaped recess when the plate is inserted into the palate of the infant.
[0021] It may be provided that the shape and arrangement of the bowl-shaped recesses are selected so that they have an offset relative to the central plane of the plate, thereby allowing a therapeutic force to be applied to the infant's premaxilla through the bowl-shaped recesses when the plate is inserted into the infant's palate. The shape and arrangement of the bowl-shaped recesses may be selected so that individual deviations of the premaxilla can be reduced, additionally or alternatively corrected in a targeted manner by the therapeutic force.
[0022] The bowl recess can be so pronounced that the shape and configuration of the bowl recess matches the shape and configuration of the premaxilla, which is useful, for example, when the current shape and configuration of the premaxilla already matches the desired shape and configuration and is to be maintained in said shape and configuration.
[0023] Depending on the shape and position of the bowl-shaped recess and the web path, various misalignments of the vomer and premaxilla can be treated in a targeted manner by the proposed plate. For example, the proposed plate, which has an offset of the bowl-shaped recess and an offset of the web path relative to the central plane of the plate, can simultaneously change the path of the vomer and the position of the premaxilla when the plate is inserted into the palate of an infant. The plate can also be provided with only an offset of the web path relative to the central plane, resulting in only a displacement of the vomer path. In this case, the bowl-shaped recess can be positioned without an offset relative to the central plane or can match the shape and position of the premaxilla. This allows for a displacement of the vomer path when the plate is inserted into the palate of an infant, while preventing the premaxilla from being displaced by the bowl-shaped recess. In a similar manner, the plate can have a web path without an offset relative to the central plane or a web path that matches the path of the vomer, and an offset of the bowl-shaped recess relative to the central plane of the plate. It is therefore possible to maintain the path of the vomer and change the shape and position of the premaxilla, which allows the proposed plate to treat multiple deviations in the maxilla of infants and young children.
[0024] In addition, the receiving portion may be located at the end of one or both of the webs extending along the central plane. One of the two webs may be rounded at the end. Preferably, the end of this web may be designed to fit the anatomical conditions of the palate, such as the nasal turbinates. However, it is also possible for both webs to be rounded at the end. Preferably, both webs may be designed at their ends to fit the anatomical conditions of the palate, such as the nasal turbinates. The end of the web extending along the central plane may directly merge with the receiving portion or may be spaced apart from the receiving portion. The transition between the end of the web extending along the central plane and the receiving portion may preferably be designed to fit the anatomical conditions of the palate, such as the nasal turbinates. Such adaptation of the web or the transition of the web to the receiving portion can improve the fit of the plate to the infant's palate when the plate is inserted into the infant's palate, thereby reducing pain for the infant.
[0025] The bowl-shaped recess may be formed such that the inner surface of the bowl-shaped recess circumferentially surrounds the premaxilla when the plate is inserted into the palate. Typically, one end of the web extending along the central plane may point forward, i.e., anteriorly, toward the body when the plate is inserted into the palate. This arrangement of the receiver on the plate has the advantage that the receiver, and therefore the bowl-shaped recess, may be positioned at the height of the premaxilla when the plate is inserted into the palate. Furthermore, by surrounding the premaxilla circumferentially with the bowl-shaped recess, the premaxilla can be held in a particularly advantageous manner when the plate is inserted into the palate of an infant. Additionally, the premaxilla can be prevented from slipping out of the bowl-shaped recess.
[0026] In addition, it may be provided that the maximum width of the receiving area of the plate, including the receiving portion, determined transversely to the central plane is at most about 80 percent, preferably at most about 70 percent, and particularly preferably at most 60 percent of the maximum width of the plate determined transversely to the central plane. The maximum width of the plate may be, for example, at most 8 cm, preferably at most 6 cm, and particularly preferably at most 5 cm. Reducing the width of the plate in this region of the receiving area is advantageous in that, when the plate is inserted into the palate, the position of the premaxilla can be changed by the plate independently from the anterior region of the lateral jaw segments. However, it may also be provided that the plate is designed so that, when the plate is inserted into the palate, the lateral segments can be moved independently from the premaxilla. For example, the displacement of the lateral segments can be simulated independently from the vomer by digital or analog model calculation. In the model calculation, the lateral segments can be individually repositioned, in particular so that their positions relative to each other can be adjusted for optimal insertion of the premaxilla. By adjusting the lateral segments individually, deviations in the palate of an infant can be corrected or at least reduced in a better, and in particular more targeted manner.
[0027] In a further embodiment, the wings may have a contact surface between the palate and the plate. The webs may protrude on one side of the plate so that they rise above the contact surface. The contact surface may typically extend across the upper surface of the wings. The webs may preferably protrude cranially from the contact surface. For example, the webs may protrude cranially from the contact surface in a stepped manner. The contact surface may prevent the webs from penetrating too deeply into the infant's nose, which could block the infant's nasal airway and pose a serious risk of infant death due to suffocation.
[0028] In a further embodiment, the height of the web, determined perpendicular to the contact surface and starting from the contact surface, can be at least 0.4 cm, preferably at least 0.8 cm, particularly preferably at least 1.2 cm, and additionally or alternatively at most 2 cm, preferably at most 1.8 cm, particularly preferably at most 1.5 cm. Alternatively, the height of the web along the central plane can vary by at most 50 percent, preferably at most 30 percent, particularly preferably at most 10 percent, of the minimum or maximum height of the web. The maximum height of the first web, for example, can deviate from the maximum height of the second web by at most 50 percent, preferably at most 30 percent, particularly preferably at most 10 percent. Alternatively or additionally, the height of the web can be at least three times, preferably at least two times, particularly preferably at least one time, the minimum width of the web determined transversely to the central plane. A web that is too low can mean, for example, that the vomer may not be supported laterally to a sufficient extent, and therefore vomer curvature or correction, respectively, cannot be prevented or achieved. The webs not exceeding the maximum height can avoid serious danger to the infant due to obstruction of the nasal airway and choking when the plate is inserted into the palate.
[0029] In a further embodiment, the webs may be spaced apart from one another in a direction transverse to the central plane. The minimum spacing of the webs from one another may be at least 0.3 cm, preferably at least 0.5 cm, particularly preferably at least 0.7 cm, and / or at most 2 cm, preferably at most 1.5 cm, particularly preferably at most 1 cm. Alternatively, the spacing of the webs from one another along the central plane may vary by less than twice, preferably less than one time, particularly preferably less than half the minimum spacing between the webs. Typically, the minimum spacing between the webs from one another may be provided to allow the vomer to fit into the free space extending between the webs when the plate is inserted into the palate.
[0030] Alternatively, each web may have a specific length along the central plane and a specific width transverse to the central plane, with the length of each web being at least twice its width, preferably at least three times, and particularly preferably at least four times.Furthermore, it may be provided that the width of each web varies by less than twice, preferably by less than one time, and particularly preferably by less than half, the smallest width of the web.
[0031] In further embodiments, the wings can be arranged on the side of the web facing away from the central plane. For example, the wings can be designed so that they reach the web. Wings that reach the web have the advantage, for example, of providing the plate with high stability, which allows the plate to withstand the forces applied when the plate is inserted without breaking.
[0032] Alternatively, the maximum length of the wings determined along the central plane can be at most 100 percent, preferably at most 90 percent, and particularly preferably at most 80 percent of the length of one or alternatively all of the webs determined along the central plane. By limiting the length of the wings, the lateral jaw segments can be kept out of the plate at least in certain regions. This allows the premaxilla to be displaced independently from the lateral jaw segments, or the lateral jaw segments to be displaced independently from the premaxilla, using the plate.
[0033] The maximum length of the wing may define a longitudinal portion aligned along the central plane. In the longitudinal portion, the maximum width of the plate, measured transversely to the central plane, may be reduced by at least 40 percent, preferably at least 50 percent, and particularly preferably at least 60 percent. The length of the longitudinal portion measured along the central plane may be at most 25 percent, preferably at most 15 percent, and particularly preferably at most 10 percent of the maximum length of the plate measured along the central plane.
[0034] In a further embodiment, the plate can include a retaining device for fastening a tensioning device to apply a force to the plate along the central plane, and the retaining device can be disposed at an end of the receiving portion extending along the central plane, facing away from the web. For example, the retaining device can protrude anteriorly from the receiving portion when the plate is inserted into the palate. The tensioning device can be coupled to the plate at the retaining device. A force can be transmitted to the plate through the retaining device by the tensioning stress of the tensioning device. Typically, when the plate is inserted into the palate, the tensioning stress or force transmission is applied posteriorly. However, the force effect can also be provided anteriorly. However, when the plate is placed on the palate of an infant, the myofunctional force applied to the plate by the infant's tongue can also be taken into account and utilized. Examples of tensioning devices can include a rubber band or a spring. For example, the force can be transmitted to the premaxilla in addition to or instead of the vomer as a therapeutic force. This allows the vomer and, in addition to or instead, the premaxilla to be displaced along the central plane by use of the plate. In this way, any misalignment of the premaxilla and vomer that has occurred can be corrected and corrected anteriorly or posteriorly. Here, the corrective effect of the inserted plate can be enhanced by the myofunctional force exerted on the plate by the infant's tongue. In addition, a therapeutic force can be applied to one or both of the lateral jaw segments to correct their position.
[0035] The retention device can have, for example, two fixation protrusions that protrude forward when the plate is inserted into the palate. The fixation protrusions can be located, for example, on either side of the central plane. The placement of the fixation protrusions can influence the direction of the treatment force across the central plane. This allows for further adjustment of the treatment force, which means, for example, that the lateral jaw segments can be moved more independently when the plate is inserted into the palate.
[0036] A set of plates is further proposed for sequentially correcting the vomer in infants with cleft lip and palate. The set of plates can help sequentially treat vomer misalignment. The web paths of plates in the set can have different offsets relative to the web path of the first plate in the set. The offset of each of these web paths relative to the web path of the first plate can increase with each additional plate, thereby gradually changing the path of the vomer with each subsequent plate.
[0037] The set of plates includes at least the first plate and the second plate, and the first spatial path of the web of the first plate along the central plane of the first plate is different from the second spatial path of the web of the second plate along the central plane of the second plate. The different paths of the web of the plates in the set can provide different treatment forces when each plate is inserted into the palate. This allows the vomer to be corrected sequentially by using the first plate and then replacing it with the second plate. It can be seen that additional plates can be provided to sequentially correct the vomer through the different paths of the web of each plate, thereby reducing vomer displacement. A set of plates having multiple plates can be used sequentially, providing that the spacing between the webs, and therefore the free space for receiving the vomer of each plate, increases with each subsequent plate. This has the advantage that the increasing volume of the infant's vomer as the infant grows can be taken into account with each successive plate in the set of plates. Additionally, misalignment of the premaxilla and lateral jaw segments can also be corrected or at least reduced with the set of plates.
[0038] Alternatively, the web of the first plate can include a first web and a second web. The web of the second plate can include a first web and a second web. Each of the webs has a first end extending along the central plane and a second end opposite the first end. The first end of the first web of the first plate can be offset by a first lateral offset in a direction transverse to the central plane of the first plate relative to the second end of the first web of the first plate. The first end of the second web of the first plate can be offset by a second lateral offset in a direction transverse to the central plane of the first plate relative to the second end of the second web of the first plate. The first end of the first web of the second plate can be offset by a third lateral offset in a direction transverse to the central plane of the second plate. The first end of the second web of the second plate may be offset relative to the second end of the second web of the second plate by a fourth lateral offset in a direction transverse to the central plane of the second plate. The first lateral offset may be at least 30 percent, preferably at least 10 percent, and particularly preferably at least 5 percent less than the third lateral offset. Additionally or alternatively, the second lateral offset may be at least 20 percent, preferably at least 10 percent, and particularly preferably at least 5 percent less than the fourth lateral offset. Additionally or alternatively, the first end of the first web of the first plate may be offset relative to the second end of the first web of the first plate by a first longitudinal offset along a direction parallel to the central plane of the first plate. The first end of the second web of the first plate may be offset relative to the second end of the second web of the first plate by a second longitudinal offset along a direction parallel to the central plane of the first plate. The first end of the first web of the second plate can be offset relative to the second end of the first web of the second plate by a third longitudinal offset along a direction parallel to the center plane of the second plate.The first end of the second web of the second plate can be offset relative to the second end of the second web of the second plate by a fourth longitudinal offset along a direction parallel to the center plane of the second plate. The first longitudinal offset can be at least 15 percent, preferably at least 10 percent, and particularly preferably at least 5 percent less than the third longitudinal offset. Additionally or alternatively, the second longitudinal offset can be at least 15 percent, preferably at least 10 percent, and particularly preferably at least 5 percent less than the fourth longitudinal offset.
[0039] The longitudinal or lateral offset allows for a targeted reduction of the premaxilla's misalignment. Typically, this allows for the premaxilla to be displaced along the central plane, in addition to or instead of along a plane perpendicular to the central plane. The targeted reduction per plate can usually be at most 0.3 cm, preferably at most 0.2 cm, particularly preferably at most 0.1 cm, and additionally or alternatively at least 0.05 cm.
[0040] Furthermore, a method for manufacturing a plate for insertion into the palate of an infant for correcting the vomer of the infant having a cleft lip and palate is proposed, the method comprising the steps of: creating and measuring an impression of the infant's maxilla to determine the spatial positioning of the infant's vomer, premaxilla, and two lateral maxillary segments relative to one another; determining a lateral deviation of the vomer of the end of the vomer toward the premaxilla, the deviation being determined transverse to the sagittal plane of the infant; and additionally or alternatively, determining a longitudinal deviation of the vomer of the end of the vomer toward the premaxilla, the deviation being determined along the sagittal plane of the infant; and manufacturing the plate; The webs of the plate are designated as a first web and a second web, each having a first end extending in one direction along the central plane and a second end opposite to the first end, thereby: (i) a first end of the first web is offset relative to a second end of the first web by a first lateral offset specified transversely to the central plane of the plate, and a first end of the second web is offset relative to a second end of the second web by a second lateral offset specified relative to the central plane of the plate; The first lateral offset and the second lateral offset are each selected in response to a pre-specified lateral deviation of the vomer, and additionally or alternatively: (ii) a first end of the first web is offset relative to a second end of the first web by a first longitudinal offset specified along a direction parallel to the central plane of the plate, and a first end of the second web is offset relative to a second end of the second web by a second longitudinal offset specified along a direction parallel to the central plane of the plate; The first longitudinal offset and the second longitudinal offset are each selected according to a pre-specified longitudinal offset of the vomer.
[0041] Typically, in the manufacturing method, an impression of the infant's maxilla is first made before the manufacture of the plates. The impression can be taken, for example, in digital format, or additionally or alternatively, in analog format. The analog impression can preferably be digitized. The deviations of the vomer, premaxilla, and lateral jaw segments can be measured from the impression. Depending on the degree of each deviation, different numbers of plates can be planned and manufactured to reduce each deviation.
[0042] Additionally, the method includes the following steps: manufacturing a first plate according to the method described above and a second plate according to the method described above; The first lateral offset of the first end of the first web of the first plate can be selected to be less than the first lateral offset of the first end of the first web of the second plate, and the second lateral offset of the first end of the second web of the first plate can be selected to be less than the second lateral offset of the first end of the second web of the second plate, and additionally or alternatively: The first longitudinal offset of the first end of the first web of the first plate can be selected to be smaller than the first longitudinal offset of the first end of the first web of the second plate, and the second longitudinal offset of the first end of the second web of the first plate can be selected to be smaller than the second longitudinal offset of the first end of the second web of the second plate.
[0043] An embodiment of a set of plates of the type proposed herein and of the method proposed herein is shown in the figures and will be explained in more detail in the following description. [Brief explanation of the drawings]
[0044] [Figure 1] Oblique view of an impression of the maxilla of an infant with misalignment of the vomer and premaxilla. [Figure 2A] FIG. 1 shows a front perspective view of an embodiment of a first plate of the proposed set of plates. [Figure 2B] FIG. 10 is a front perspective view of the second plate of the proposed set of plates. [Figure 2C] FIG. 1 shows a front perspective view of a first plate superimposed with a second plate of the proposed set of plates. [Figure 3A] FIG. 1 shows a rear perspective view of the first plate of the proposed set of plates. [Figure 3B] FIG. 10 is a rear perspective view of the second plate of the proposed set of plates. [Figure 4A] Schematic plan view of the arrangement of the plate receivers and two webs of the proposed set of plates. [Figure 4B]Schematic plan view of the arrangement of the plate receivers and two webs of the proposed set of plates. [Figure 4C] Schematic plan view of the arrangement of the plate receivers and two webs of the proposed set of plates. [Figure 4D] Schematic plan view of the arrangement of the plate receivers and two webs of the proposed set of plates. [Figure 5A] 10A and 10B show longitudinal sections of plates of the proposed set of plates with different transitions between the web and the receiving part. [Figure 5B] 10A and 10B show longitudinal sections of plates of the proposed set of plates with different transitions between the web and the receiving part. [Figure 5C] 10A and 10B show longitudinal sections of plates of the proposed set of plates with different transitions between the web and the receiving part. [Figure 5D] 10A and 10B show longitudinal sections of plates of the proposed set of plates with different transitions between the web and the receiving part. DETAILED DESCRIPTION OF THE INVENTION
[0045] Referring to the figures, an embodiment of a set of plates for sequentially correcting the vomer in an infant with a cleft lip and palate and reducing premaxillary deviation in an infant is shown, which can be used sequentially to correct the infant's vomer, prevent the infant's vomer from bowing, and reduce premaxillary deviation in an infant.
[0046] FIG. 1 shows an oblique view of a digital impression 10 of the maxilla of an infant with a cleft lip and palate. The impression 10 has a circular outer contour, defining a central impression plane 19 along its diameter. The central impression plane 19 corresponds to the infant's sagittal plane. Two raised lateral maxillary segments 14, 15, formed on opposite lateral regions of the impression 10, are shown extending on either side along the central impression plane 19. The infant's vomer 13 is shown as a web-like ridge between the maxillary segments 14, 15. The first end of the vomer 13 is shown positioned midway between the maxillary segments 14, 15. From its first end, the vomer 13 extends along the central impression plane 19 at an angle of approximately 10 degrees relative to the central impression plane 19. The infant's premaxilla 12 is shown raised at the second end of the vomer 13, opposite the first end. The premaxilla 12 is connected to the second end of the vomer 13 and includes two spherical structures. The spherical structures are located on the side of the premaxilla 12 facing away from the second end of the vomer 13. Furthermore, the premaxilla 12 extends at an angle of approximately 30 degrees relative to the impression center plane 19. The second ends of the premaxilla 12 and the vomer 13 surround the first lateral maxillary segment 14 of the two lateral maxillary segments 14, 15 by a short distance at least in some areas. Such a short distance typically facilitates rapid integration of the premaxilla 12, the vomer 13, and the first maxillary segment 14. However, the large distance between the first maxillary element 14 and the opposite second maxillary element 15, resulting from this misalignment of the premaxilla 12 and the vomer 13, delays integration of the premaxilla 12, the vomer 13, and the second maxillary segment 15. Said deviation usually results in cleft lip and palate in the upper jaw of infants and young children. Such deviations can be treated with the proposed set of plates.
[0047] The spatial arrangement and degree of deviation of the premaxilla 12, vomer 13, and lateral jaw segments 14, 15 can be measured using an impression 10 of the maxilla of an infant with a cleft lip and palate, as shown in Figure 1. The points shown in Figure 1 can be used for the measurement. These points represent the base point B', the posterior point Vp or midpoint V of the vomer 13, the gingival sulcus point K or K' of the first or second maxillary element 14, 15, the alveolar cleft pole point P1 or P1', the anterior points P and P' of the alveolar crest, and the interincisal point I of the premaxilla 12. Subsequently, the lateral deviation of the vomer, determined across the impression central plane 19, and the longitudinal deviation of the end of the vomer 13 toward the premaxilla 12, determined along the impression central plane 19, can be determined. Furthermore, the deviation of the premaxilla 12 and the lateral jaw segments 14, 15 can be determined from the impression 10. The lateral deviation of the vomer and / or the deviation of the premaxilla 12 and the lateral jaw segments 14, 15 can be represented and determined by the distance between various points across the impression central plane 19, for example, as shown in Table 1. The first impressions listed in Tables 1 and 2 were taken from the palate of an infant. The remaining impressions were designed by model calculation. However, it may also be possible to take individual impressions from the palate of an infant. The longitudinal deviation of the vomer can be determined by the distance from the base point B' to the posterior point Vp of the vomer 13 along the impression central plane 19, for example, as listed in Table 2. The corresponding distances for seven digital impressions are shown as an example. The specified values have been rounded to the nearest decimal place. Depending on the degree of individual deviation, the number of plates of the proposed type can be planned and defined to produce a set of plates for progressively correcting the premaxilla 12 and vomer 13 of infants with cleft lip and palate and progressively reducing the deviation of the premaxilla 12, vomer 13 and lateral jaw segments 14, 15 of the infant.
[0048] [Table 1]
[0049] [Table 2]
[0050] After sequential use of each plate of the proposed set of plates in an infant with a cleft lip and palate, the premaxilla 12 and vomer 13 will extend along the impression central plane 19 approximately midway between the maxillary segments 14, 15. The spherical structure of the premaxilla 12 will then typically be positioned approximately equidistant from the lateral jaw segments 14, 15 on either side of the impression central plane 19. Restoring uniform positioning of these maxillary elements can promote uniform union of said maxillary elements and reduce the occurrence of splitting.
[0051] 2A and 3A show an embodiment of a first plate 1 of the proposed set of plates for palatal insertion in infants with cleft lip and palate to correct and reduce misalignment of the infant's premaxilla 12 and vomer 13. FIG. 2A shows the first plate 1 in a front perspective view. In contrast, FIG. 3A shows the first plate 1 in a rear perspective view. Plate 1 has two webs 3 extending adjacent to each other on both sides of the upper surface of the plate along an imaginary central plane 9 perpendicular to plate 1. Between the webs 3, a free space 6 is formed for receiving and correcting the vomer 13. These webs 3 extend from the first end of plate 1 in a straight line parallel to central plane 9, at a uniform distance from each other, e.g., 0.8 cm. However, the distance may be, for example, at least 0.3 cm and, for example, at most 1.5 cm. Additionally, the spacing may not be uniform but may vary, for example, gradually along the central axis, in a range of 0.3 cm to 1.5 cm. The length of the web 3 along the central plane 9 is typically greater than half the length of the plate 1 along the central axis 9, e.g., 5 cm. The width of the plate 1 transverse to the central axis 9 is, for example, 4.5 cm. The central plane 9 of the plate 1 corresponds to the sagittal plane of the palate when the plate 1 is inserted into the palate.
[0052] Table 3 presents the dimensions of the web 3 and plates of a proposed set of plates for sequential use. Seven plates are listed as an example. The values provided are rounded to the nearest decimal place. Depending on the anatomical condition of the infant's palate, the height of the web 3 may need to be varied between different plates of the set. For example, the height of the web 3 may increase for each of the first three plates and remain constant from the fourth plate onwards. For example, the height of the web 3 may need to be initially lower to progressively displace the infant's nasal turbinates until the web 3 can encircle the infant's vomer 13. The length of the plates of the set may increase, for example, from the first plate to the second plate, to encircle the infant's vomer 13 over as large an area as possible, thereby making it easier to straighten the infant's vomer 13. For example, starting with the third plate in a set, the length of the individual plates may be progressively reduced with each plate because the infant's vomer 13 tends to straighten with increasing numbers of plates, reducing the surface area of the web 3 that may be required to encircle the vomer 13. Insertion of the plates into the infant's palate and infant comfort may be improved by progressively reducing the length of the plates with each plate in a set without affecting plate function.
[0053] [Table 3]
[0054] When plate 1 is inserted into the palate, vomer 13 is received within free space 6 and sandwiched between two webs 3. The shape of plate 1 is adapted to the palate of the infant so that plate 1 is supported on the palate, particularly by wings 4, and fixed in multiple directions relative to the palate. The stable fit of plate 1 on the palate and the offset of the path of webs 3 from the current path of vomer 13 allow a therapeutic force to impart a new path to the shape of the path of vomer 13 confined within free space 6. The therapeutic force is considered to be the force exerted on the palate of the infant by the proposed plate 1 when plate 1 is inserted into the palate of the infant.
[0055] The webs 3 of the plate 1 are formed linearly along the central plane 9 and extend alongside one another along the central plane 9. The adjacent linear webs 3 are particularly advantageous for applying a therapeutic force to the vomer 13 until the path of the vomer 13 coincides with the path of the adjacent linear webs 3 along the central plane 9. By using the plate 1 shown in FIGS. 2A and 3A, the curvature of the vomer 13 can be corrected by the therapeutic force, or the curvature of an uncurved vomer 13 can be prevented. An uncurved vomer 13 can significantly reduce the occurrence of indirect damage, particularly obstruction of the patient's breathing in the nasal region.
[0056] Furthermore, each of the webs 3 has a first end pointing in the same direction as the first end of the plate 1. The receiving portion 2 having a bowl-shaped recess is disposed at a second end of the web 3 opposite the first end of the web 3. The bowl-shaped recess has two spherical bulges and is designed so that the inner surface of the bowl-shaped recess can circumferentially surround the premaxilla 12 when the plate 1 is inserted into the palate. By circumferentially surrounding the premaxilla 12 by the bowl-shaped recess, the premaxilla can be held in a particularly advantageous manner when the plate is inserted into the palate of an infant. The maximum width of the receiving area of the plate 1, including the receiving portion 2, determined in a direction transverse to the central plane 9 is 80 percent of the maximum width of the plate 1 determined in a direction transverse to the central plane 9. The shape and arrangement of the receiving portion 2 of the plate 1 shown in FIG. 2A allow the premaxilla 12 to be positioned in a straight line and evenly on both sides of the central axis 9 by the treatment force of the plate 1. Additionally, the shape and configuration of the premaxilla 12 can be maintained through the use of Plate 1. Plate 1 shown in FIG. 2A can be the last plate in a set of plates for sequential treatment, which can be used for the desired final state of the path of the vomer 13 and the shape and configuration of the premaxilla 12.
[0057] Furthermore, the plate 1 has two wings 4 extending on either side of the central surface 9, and the wings 4 are designed to abut the palate in at least some areas. The wings 4, with their upper surfaces, form a contact surface between the palate and the plate 1 when the plate 1 is inserted into the palate. The wings 4 enable the plate 1 to be inserted into a specific position within the palate of an infant. In addition, the wings 4 support a tight fit of the plate 1 on the palate of an infant when the plate 1 is inserted into the palate.
[0058] The web 3 rises above the contact surface and projects perpendicularly, i.e. cranially, from the contact surface to a height of, for example, 0.8 cm. The contact surface ensures that the web 3 does not penetrate too deeply cranially into the baby's nose when the plate 1 is inserted into the palate, in order to avoid breathing difficulties for the baby caused by the web 3.
[0059] Additionally, wings 4 are disposed on the side of web 3 facing away from central plane 9 such that each wing 4 reaches a respective web 3. The maximum length of wings 4 determined along central plane 9 is 80 percent of the length determined along central plane 9. Additionally, the maximum length of wings 4 defines a longitudinal portion aligned along central plane 9 such that the maximum width of plate 1 determined transverse to central plane 9 is reduced by 50 percent in the longitudinal portion, and the length of the longitudinal portion determined along central plane 9 is 15 percent of the maximum length of plate 1 determined along central plane 9. This causes the plate to form a T-shaped structure.
[0060] Furthermore, the plate has a retaining device 5 for fastening the tensioning device in order to apply a force to the plate along the central plane by means of two fixing protrusions, which are arranged on either side of the central plane 9 at the ends of the receiving part 2 that face away from the web 3 and extend in a direction along the central plane 9. The fixing protrusions project from the receiving part 2 to the front, i.e. forward.
[0061] When plate 1 is inserted into the palate of an infant, the fixation projections typically protrude from the infant's oral cavity. Rubber bands can be fastened to the protruding fixation projections to generate a force against plate 1 along central plane 9 to displace premaxilla 12 and vomer 13 along central plane 9. In this way, plate 1 can correct misalignment of premaxilla 12 and vomer 13 anteriorly and posteriorly, and can also prevent bowing of vomer 13.
[0062] 2B and 3B show a front view of an embodiment of a second plate 1 of the proposed set of plates for palatal insertion in an infant with cleft lip and palate to correct the infant's vomer 13. FIG. 2B shows the second plate 1 in a front perspective view. FIG. 3B shows the second plate 1 in a rear perspective view. The second plate 1 essentially includes the features of the first plate 1 shown in FIG. 2A, but differs in that the second plate 1 has an offset in the shape and arrangement of the path of the web 3 and the receiver 2 relative to the shape and arrangement of the path of the web 3 and the receiver 2 of the first plate 1.
[0063] The second plate 1 of the set of plates for sequential treatment shown in Figure 2B can be suitable for the initial or starting state of the maxilla of an infant with a cleft lip and palate. The second plate 1 can provide a first displacement in the path of the initial vomer 13 and the shape and configuration of the initial premaxilla 12, in which case the second plate has a first lateral displacement in the path of the web 3 and the shape and configuration of the receiver 2 relative to the path of the initial vomer 13 and the shape and configuration of the premaxilla 12, and is inserted into the infant's palate first. After the path of the web 3 of the second plate 1 is imparted to the path of the vomer 13 and the shape and configuration of the receiver 2 is imparted to the shape and configuration of the premaxilla 12, the second plate 1 can be replaced with an additional plate 1 of the set of plates. The additional plate 1 can effect a second displacement of the path of the vomer 13 and the shape and configuration of the premaxilla 12, in which case the additional plate 1 has a second lateral offset of the path of the web 3 and the shape and configuration of the receiver 2 relative to the path of the vomer 13 and the shape and configuration of the premaxilla 12 in the initial state, the second lateral offset being greater than the first lateral offset, and the additional plate 1 is inserted a second time into the infant's palate. The additional plate 1 can also be replaced with a new plate 1 having a further lateral offset of the path of the web 3 and the shape and configuration of the receiver 2 relative to the path of the vomer 13 and the shape and configuration of the premaxilla 12 in the initial state, the further lateral offset being greater than the second lateral offset. The direction of the lateral offset is represented by directional arrow 8. This successive exchange of plates in the set of plates can be performed until the path of the vomer 13 and the shape and position of the premaxilla 12 are displaced until the final plate 1 of FIG. 2A can be inserted and the final treatment step to correct the vomer 13 and premaxilla 12 can be completed.
[0064] 2C shows a front perspective view of the first plate 1 of FIG. 2A superimposed with the shape and arrangement of the path of the web 3 and the receiver 2 of the second plate 1 of FIG. 2B of the proposed set of plates, represented by a dashed outline. This superposition makes it clear that the second plate 1 has a lateral offset in the second end of the web 3 and the path of the receiver 2 relative to the second end of the web 3 and the path of the receiver 2 of the first plate 1. However, similar to the lateral offset, a longitudinal offset in the second end of the web 3 and the path of the receiver 2 of the second plate 1 is also possible, along with a lateral offset relative to the second end of the web 3 and the path of the receiver 2 of the first plate 1.
[0065] Typically, the lateral offset is determined by the misalignment of the premaxilla 12, vomer 13, and lateral jaw segments 14, 15 calculated from an impression 10 of the maxilla of an infant with a cleft lip and palate. The lateral offset is designed so that a therapeutic force is applied to the premaxilla 12 and vomer 13 of the infant by the second plate 1 upon insertion of the second plate 1 into the infant's palate. This is typically achieved by having the path of the web 3 of the second plate 1 have a smaller lateral offset than the lateral offset imparted by the misalignment of the premaxilla 12 and vomer 13. Advantageously, the therapeutic force should be applied in the opposite direction to that indicated by the directional arrow 8 so that the misalignment of the premaxilla 12 and vomer 13 can be reduced by the inserted second plate 1. By inserting a second plate 1 into the palate of an infant with a cleft lip and alveolar cleft, a force can be applied to the premaxilla 12 and vomer 13 until the premaxilla 12 and vomer 13 are displaced so that they are positioned in a predetermined shape by the web 3 and receptacle of the second plate 1. The second plate 1 inserted into the palate can then be replaced with the first plate 1 to provide new forces acting on the displaced premaxilla 12 and vomer 13. The premaxilla 12 and vomer 13 are again displaced by the first plate 1 inserted into the palate until they assume the shape defined by the first plate 1. The premaxilla 12 and vomer 13 are then positioned in a straight line along the central plane 9 at a position midway between the maxillary segments 14 and 15. Such sequential treatment with a set of plates allows for this correction of misalignment of the premaxilla 12 and vomer 13 and also for avoiding bowing of the vomer 13 .
[0066] Depending on the severity of the deviation, further plates 1 may be provided from the set of plates, which are successively inserted into the palate of the infant to progressively reduce the deviation of the premaxilla 12 and vomer 13. When producing further plates, it must be taken into account that the volume of the maxillary element will increase over time and further plates will need to be adapted to the new volume.
[0067] 4A to 4D show diagrammatically different arrangements of the receiving parts 2 and webs 3 relative to the central plane 9 of the plates from a set of plates. The arrangement of the receiving portions 2 and webs 3 shown in Figure 4A corresponds to the arrangement of the receiving portions 2 and webs 3 of the first plate 1 in Figure 2A. The webs 3 are arranged linearly along the central plane 9, and the receiving portions 2 are evenly spaced on both sides of the central plane 9.
[0068] However, as shown in Figures 4B and 4C, it is also possible to provide either a receiver 2 with a lateral offset across the central plane 9, for example, relative to the arrangement of the receiver 2 shown in Figure 4A, or a web path with a lateral offset across the central plane 9, for example, relative to the arrangement of the web 3 shown in Figure 4A. In this way, the path of the vomer 13 can be maintained and the shape and arrangement of the premaxilla 12 can be changed, or the path of the vomer 13 can be changed and the shape and arrangement of the premaxilla 12 can be maintained. Depending on the shape and arrangement of the receiver 2 and the path of the web 3, various misalignments of the vomer 13 and premaxilla 12 can be treated independently in a targeted manner with sets of plates.
[0069] The arrangement of the receivers 2 and webs 3 shown in Figure 4D corresponds to the arrangement of the receivers 2 and webs 3 of the second plate 1 in Figure 2B. The arrangement of the receivers 2 and the path of the webs has, for example, a lateral offset across the central plane 9 relative to the arrangement of the receivers 2 and webs 3 shown in Figure 4A. The path of the vomer 13 and the arrangement of the premaxilla 12 can be changed simultaneously in this way.
[0070] 5A-5D show cross sections along the center plane 9 of different plates of the set of plates. The plates each have a transition from the web 3 to the receiving portion 2. FIG. 5A shows a rectangular web 3 and a gap with a linear plateau between the bowl-shaped recess of the receiving portion 2 and the web 3. The plate shown in FIG. 5B also has a rectangular web 3, and there is a direct transition between the web 3 and the bowl-shaped recess of the receiving portion 2.
[0071] On the other hand, Figure 5C shows a rounded web 3 with a gap between the web 3 and the bowl-shaped recess of the receiving part 2, which also has a linear flat area. The plate shown in Figure 5D also has a rounded web 3, with a direct transition between the web 3 and the bowl-shaped recess of the receiving part 2. Depending on the anatomical conditions of the infant's palate, such as the nasal turbinates, the end of the web 3 and / or the transition between the web 3 and the bowl-shaped recess of the receiving part 2 can be adapted to the anatomical conditions of the infant's palate. The adjustment and rounded web 3 can facilitate the reduction of pain to the infant when the plate is inserted into the infant's palate.
Claims
1. A plate (1) for palate insertion, said plate (1) having wings (4) on either side of an imaginary central plane (9) perpendicular to said plate (1), said wings being designed so that they abut the palate in at least some area; A plate (1) characterized in that it has two webs (3) extending on either side of the central surface (9), thereby forming a free space extending between the webs (3) for receiving the vomer (13).
2. The plate (1) according to claim 1 comprises a receiving portion (2) for receiving the premaxilla (12), characterized in that the receiving portion (2) includes at least one bowl-shaped recess.
3. 3. The plate (1) according to claim 2, characterized in that the receiving portion (2) is arranged at one end of one of the webs (3) extending in a direction along the central plane (9), and the bowl-shaped recess is designed so that the inner surface of the bowl-shaped recess circumferentially surrounds the premaxilla (12) when the plate (1) is inserted into the palate.
4. 4. The plate (1) according to claim 2 or 3, characterized in that the maximum width of the receiving area of the plate (1) including the receiving portion (2), determined in a direction transverse to the central plane (9), is at most 80 percent of the maximum width of the plate (1), determined in a direction transverse to the central plane (9).
5. A plate (1) according to any one of claims 1 to 3, characterized in that the wings (4) have a contact surface of the plate (1) that contacts the palate, and the webs (3) extend from one side of the plate so as to rise above the contact surface.
6. The height of the web (3), determined perpendicular to the contact surface and starting from the contact surface, is: is at least 0.4 cm, and 6. Plate (1) according to claim 5, characterized in that it is at most 2 cm.
7. The webs (3) are spaced apart from one another in a direction transverse to the central plane (9), and the minimum spacing between the webs (3) is: is at least 0.3 cm, and Plate (1) according to any one of the preceding claims, characterized in that it is at most 2 cm.
8. 8. Plate (1) according to any one of the preceding claims, characterized in that the wings (4) are arranged on the sides of the webs (3) facing away from the central plane (9).
9. 9. A plate (1) according to claim 8, characterized in that the maximum length of the wings (4) determined along the central plane (9) is at most 100 percent of the length of one of the webs (3) determined along the central plane (9).
10. 10. The plate (1) according to claim 9, characterized in that the maximum length of the wings (4) defines a longitudinal portion aligned along the central plane (9), the maximum width of the plate (1) determined transversely to the central plane (9) being located in the longitudinal portion and being reduced by at least 40 percent of the previous maximum width of the plate (1) determined transversely to the central plane (9) according to claim 4, and the length of the longitudinal portion determined along the central plane (9) being at most 25 percent of the maximum length of the plate (1) determined along the central plane (9).
11. A plate (1) according to any one of claims 2 to 4 or any one of claims 3 to 10 when dependent on any one of claims 2 to 4, characterized in that the plate (1) comprises a retaining device (5) for fastening a tensioning device to apply a force to the plate (1) along the central plane (9), the retaining device (5) being arranged at one end of the receiving part (2) extending in a direction along the central plane (9) facing away from the web (3).
12. A set of plates for progressive correction of the vomer (13) of an infant with cleft lip and palate, comprising:
12. A set of plates comprising a first plate according to any one of claims 1 to 11 and a second plate according to any one of claims 1 to 11, wherein a first spatial path of the web of the first plate in a direction along the central plane (9) of the first plate is different from a second spatial path of the web of the second plate in a direction along the central plane (9) of the second plate.
13. 13. The set of plates according to claim 12, The web (3) of the first plate comprises a first web and a second web, the web (3) of the second plate comprises a first web and a second web; Each of the webs has a first end extending along the central plane (9) and a second end opposite the first end; the first end of the first web of the first plate is offset by a first lateral offset relative to the second end of the first web of the first plate transverse to the central plane (9) of the first plate; the first end of the first web of the first plate is offset by a second lateral offset relative to the second end of the second web of the first plate transverse to the central plane (9) of the first plate; the first end of the first web of the second plate is offset by a third lateral offset relative to the second end of the first web of the second plate transverse to the central plane (9) of the second plate; the first end of the second web of the second plate is offset by a fourth lateral offset relative to the second end of the second web of the second plate transverse to the central plane (9) of the second plate; the first lateral offset being at least 5 percent less than the third lateral offset; the second lateral offset being at least 5 percent less than the fourth lateral offset; the first end of the first web of the first plate is offset relative to the second end of the first web of the first plate by a first longitudinal offset along a direction parallel to the central plane (9) of the first plate; and the first end of the second web of the first plate is offset relative to the second end of the second web of the first plate by a second longitudinal offset along a direction parallel to the central plane (9) of the first plate; the first end of the first web of the second plate is offset relative to the second end of the first web of the second plate by a third longitudinal offset along a direction parallel to the central plane (9) of the second plate; the first end of the second web of the second plate is offset relative to the second end of the second web of the second plate by a fourth longitudinal offset along a direction parallel to the central plane (9) of the second plate; the first longitudinal offset being at least 5 percent less than the third longitudinal offset; the second longitudinal offset being at least 5 percent less than the fourth longitudinal offset; A set of plates including at least one of:
14. A method for manufacturing an intrapalatal plate (1) for correcting the vomer (13) of an infant with a cleft lip and palate, comprising: creating and measuring an impression (10) of the infant's maxilla to determine the spatial arrangement of the infant's vomer (13), premaxilla (12), and two lateral maxillary segments (14, 15) relative to one another; determining a lateral deviation of the end of the vomer (13) toward the premaxilla (12) determined in a direction transverse to the sagittal plane (19) of the infant; forming a plate according to any one of claims 1 to 11, wherein the webs (3) of the plate (1) are designed as first and second webs, each having a first end extending in one direction along the central plane (9) and a second end opposite the first end, the first end of the first web is offset relative to the second end of the first web by a first lateral offset specified transversely to the central plane (1) of the plate (1), and the first end of the second web is offset relative to the second end of the second web by a second lateral offset specified relative to the central plane (9) of the plate (1); The method, wherein the first lateral offset and the second lateral offset are each selected according to a pre-specified lateral deviation of the vomer.
15. The method of claim 14 further comprising: determining a longitudinal deviation of the end of the vomer (13) toward the premaxilla (12) determined along a sagittal plane (19) of the infant; the first end of the first web is offset relative to the second end of the first web by a first longitudinal offset specified along a direction parallel to the central plane (9) of the plate (1), and the first end of the second web is offset relative to the second end of the second web by a second longitudinal offset specified along a direction parallel to the central plane (9) of the plate (1); The method, wherein the first longitudinal offset and the second longitudinal offset are each selected according to a pre-specified longitudinal deviation of the vomer.
16. 1. A method for manufacturing a set of plates for insertion into the palate of an infant having a cleft lip and palate to correct the vomer (13) of the infant, comprising: manufacturing a first plate according to claim 14 and a second plate according to claim 14; the first lateral offset of the first end of the first web of the first plate is selected to be less than the first lateral offset of the first end of the first web of the second plate, and the second lateral offset of the first end of the second web of the first plate is selected to be less than the second lateral offset of the first end of the second web of the second plate.
17. The method of claim 15, the first longitudinal offset of the first end of the first web of the first plate is selected to be less than the first longitudinal offset of the first end of the first web of the second plate, and the second longitudinal offset of the first end of the second web of the first plate is selected to be less than the second longitudinal offset of the first end of the second web of the second plate.
Citation Information
Patent Citations
Treating Cleft Palate
US20110060438A1