Midfacial expander device with temporary anchorage devices and protraction wire support assembly

Abstract

The present invention discloses a midfacial expander device with temporary anchorage devices (TADs) and protraction wire support assembly. The device comprises at least one alignment rod and at least one sleeve to receive the alignment rod therein. The device comprises a first expander body and a second expander body to receive the alignment rod and the sleeve. The device comprises an expansion screw assembly extending between the first and second expander bodies. The device further comprises a first anchor body and a second anchor body to support the respective first expander body and second expander body. The device comprises assembly screws to fasten the expander body to the anchor body. The device comprises temporary anchorage devices for application of the device to the patient's maxilla

Description

MIDFACIAL EXPANDER DEVICE WITH TEMPORARY ANCHORAGE DEVICES AND PROTRACTION WIRE SUPPORT ASSEMBLYCROSS-REFERENCE TO RELATED APPLICATIONSThe present application claims the benefit of US provisional Application US 63 / 599,195 filed on 15th November 2023, entitled " MIDFACIAL EXPANDER DEVICE WITH TEMPORARY ANCHORAGE DEVICES" which further claims the benefit of US provisional application 63 / 618,297 filed on 6thJanuary 2024 entitled “MIDFACIAL EXPANDER DEVICE WITH TEMPORARY ANCHORAGE DEVICES AND PROTRACTION WIRE SUPPORT ASSEMBLY”, the contents of which are hereby incorporated by reference.TECHNICAL FIELD

[0001] The present invention generally relates to orthopedic device. More specifically, the present invention relates to a midfacial expander device with temporary anchorage devices (TADs) and protraction wire support assembly.BACKGROUND

[0002] The underdevelopment of the facial bones such as midface bones, maxilla, or a constricted maxilla is commonly found in all age groups. This often results in a downwardly rotated and posteriorly positioned mandible. In adults, it often manifests as postural and temporomandibular problems, recessed chins, flattened skull bases and vertically grown faces. Also, it causes psychological side effects, craniofacialdeformities, and obstructive sleep apnea (OSA), in which the patient’s airway is too small to withstand normal tongue and soft tissue collapse during sleep, causing the airway to cut off at night, resulting in disturbed sleep and in some cases a drop of oxygen levels.

[0003] The underdevelopment is caused by improper development of facial and oral muscles, weak nasal breathing patterns, weak tongue musculature and posture, a soft diet during infancy, untreated impedances to nasal breathing such as tongue ties, enlarged adenoids and tonsils, a diet that causes inflammation of the airways, and prior orthodontic treatment that was aimed at limiting the growth of the skull using appliances such as headgears, or aimed at reducing the size of the oral cavity.

[0004] The midface deficiencies are often treated surgically, whereby an antero- posteriorly deficient maxilla, or other parts of the cranium, is osteotomized and advanced. However, such surgeries are known for the risk of relapse and injury to neurovascular structures. Further, non- surgical devices exist but those have structural deficiencies.

[0005] Therefore, there is a need for a solution that effectively addresses midface deficiencies with a more mechanically robust and less invasive procedure.SUMMARY

[0006] The present invention discloses a midfacial expander device with temporary anchorage devices (TADs) and protraction wire support assembly. The midfacial expander device comprises a first expander body comprising a first base having a first side and a second side opposite to the first side, a first sleeve extends from the first side of the first base and a first alignment rod extends from the second side of the first base. The first sleeve is parallel to the first alignment rod, and the first base comprises a first threaded hole.

[0007] The midfacial expander device further comprises a second expander body disposed parallel to the first expander body. The second expander body comprises a second base having a first side and a second side opposite to the first side, a second sleeve extends from the second side of the second base and a second alignment rod extends from the first side of the second base. The first sleeve is configured to receive the second alignment rod and the second sleeve is configured to receive the first alignment rod. The second base comprises a second threaded hole coaxial to the first threaded hole of the first base and parallel to an axis of the alignment rods. In one embodiment, the first alignment rod and the second alignment rod are press fit connected to the first expander body and the second expander body, respectively. The midfacial expander device further comprises an adjustable expansion screw assembly extends between the first expander body and the second expander body.

[0008] The midfacial expander device further comprises a first anchor body configured to support the first expander body. The first anchor body comprises a first base portion and a first support portion extends from at least a portion of a periphery the first base portion and defines a first cavity. The first cavity is configured to support the first base of the first expander body.

[0009] The midfacial expander device further comprises a second anchor body configured to support the second expander body. The first anchor body and the second anchor body are configured to fix the device to a maxilla of the patient via one or more anchor screws. The second anchor body comprises a second base portion and a second support portion extends from at least a portion of a periphery the second base portion and defines a second cavity. The second cavity is configured to support the second base of the second expander body.

[0010] The first expander body comprises one or more first threaded assembly holes and the first anchor body comprises one or more second threaded assembly holes. The first threaded assembly holes are arranged complementary to the arrangement of the second threaded assembly holes. The first threaded assembly holes of the first expander body and the second threaded assembly holes of the first anchor body are fastened via one or more assembly screws.

[0011] The second expander body comprises one or more third threaded assembly holes and the second anchor body comprises one or more fourth threaded assembly holes. The third threaded assembly holes are arranged complementary to the arrangement of the fourth threaded assembly holes. The third threaded assembly holes of the second expander body and the fourth threaded assembly holes of the second anchor body are fastened via one or more assembly screws.

[0012] The first anchor body comprises one or more first threaded anchor holes and the second anchor body comprises one or more second threaded anchor holes. The first threaded anchor holes and the second threaded anchor holes are configured to receive one or more anchor screws to fix the device to the maxilla of the patient.

[0013] In one embodiment, each base portion comprises a first side, a second side opposite to the first side, a third side, a fourth side opposite to the third side. Each support portion comprises a front support portion and a side support portion. The front support portion extends from the first side of the first base portion and the side support portion extends from the third side of the first base portion. The side support portion comprises one or more spaces or gaps to allow passage of alignment rods and sleeves.

[0014] In another embodiment, the front support portion is configured to support at least one temporary anchorage assembly, and the rear support portion is configured to support at least one temporary anchorage assembly. Each temporary anchorage assembly comprises a hollow locking member and a temporary anchorage screw. The hollow locking member comprises a cylindrical portion comprising a plurality of first threads at an interior side of the hollow locking member, and the temporary anchorage screw comprises a head portion having a plurality of second threads at an exterior side. The temporary anchorage screw is configured to lock with the hollow locking member as the second threads of the temporary anchorage screw screws over the first threads of the hollow locking member. In yet another embodiment, at least one of the front support portion and the rear support portion is configured to support at least one temporary anchorage assembly.

[0015] In another embodiment, the device further comprises a first support member attached to an exterior side of the first anchor body. The exterior side defines an outer surface of the first anchor body opposite to a side of the first sleeve and the first alignment rod. The first support member is configured to angularly support at least two temporary anchorage assemblies. The device further comprises a second support member attached to an exterior side of the second anchor body. The second support member is configured to angularly support at least two temporary anchorage assemblies.The exterior side of the second anchor body defines an outer surface of the second anchor body opposite to a side of the second sleeve and the second alignment rod.

[0016] The device further comprises one or more flange members extending from the exterior side of the first anchor body and the second anchor body. The first support member comprises one or more holes arranged complementary to the arrangement of flange members to receive the flange members of the first anchor body therein for affixing the first support member to the first anchor body. The second support member comprises one or more holes arranged complementary to the arrangement of flange members to receive the flange members of the second anchor body therein for affixing the second support member to the second anchor body.

[0017] In yet another embodiment, each support portion comprises a rear support portion extending from the second side of the first base portion and the second base portion, respectively. In yet another embodiment, at least one of the front support portion and the rear support portion comprises one or more holes to receive one or more protraction wires.

[0018] In yet another embodiment, the front support portion is configured to support at least one temporary anchorage assembly and the rear support portion comprises one or more holes to receive one or more protraction wires

[0019] In yet another embodiment, the front support portion is configured to support at least one temporary anchorage assembly and the rear support portion is configured to support at least one temporary anchorage assembly. Further, a top surface of the front support portion has additional space compared to a top surface of the rear support portion.

[0020] In yet another embodiment, the side support portion is configured to support at least one temporary anchorage assembly.

[0021] In one embodiment, the expansion screw assembly comprises an intermediate activation member, a first threaded portion, and a second threaded portion. The intermediate activation member having a first side and a second side opposite to the first side. The first threaded portion extends from the first side of the intermediate activation member to the first threaded hole of the first expander body and the second threaded portion extends from the second side of the intermediate activation member to the second threaded hole of the second expander body.

[0022] In one embodiment, the first and the second side of the intermediate activation member comprises at least one tapered portion. In one embodiment, the intermediate activation member has a hexagon shape.

[0023] In yet another embodiment, the expansion screw assembly comprises an intermediate activation member, a first rod member extending from one end of the intermediate activation member, and a second rod member extending from the opposite end of the intermediate activation member. The first and second rod members are configured to telescope within the intermediate activation member. The intermediate activation member designed as an elongated hollow member. The intermediate activation member having an interior hollow portion comprising inner threads extending along at least a portion of its length. The interior hollow portion including a first hollow portion and a second hollow portion integrally extending from the first hollow portion, featuring different inner diameters. The first rod member with a first threaded portion featuring multiple threads formed on an exterior side. The second rod member comprising a first portion designed to fit within the hollow portion, incorporating a third hollow portion and a second threaded portion with multiple threads along a portion ofits length. The first portion of the second rod member complements the second hollow portion of the intermediate activation member. The first rod member passes through the first hollow portion and into the third hollow portion of the second rod member within the intermediate activation member, and activation of the intermediate activation member causes the first and second threads of the rod members to reversely thread over the inner threads of the first and second hollow portions, facilitating telescopic retraction.

[0024] In yet another embodiment, the device comprises at least two first blocks. At least one first block extends perpendicularly from a midportion of the first sleeve and at least one first block extends perpendicularly from a midportion of the second sleeve. The first blocks extend in a direction of anchor screws.

[0025] In yet another embodiment, the device comprises at least two second blocks. At least one second block extends perpendicularly from the fourth side of the base portion of the first anchor body and at least one second block extends perpendicularly from the fourth side of the base portion of the second anchor body. The second blocks extend in a direction opposite to anchor screws.

[0026] The above summary contains simplifications, generalizations and omissions of detail and is not intended as a comprehensive description of the claimed subject matter but, rather, is intended to provide a brief overview of some of the functionality associated therewith. Other systems, methods, functionality, features and advantages of the claimed subject matter will be or will become apparent to one with skill in the art upon examination of the following figures and detailed written description.BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The description of the illustrative embodiments can be read in conjunction with the accompanying figures. It will be appreciated that for simplicity and clarity of illustration, elements illustrated in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements are exaggerated relative to other elements. Embodiments incorporating teachings of the present disclosure are shown and described with respect to the figures presented herein, in which:

[0028] FIG. 1 exemplarily illustrates a perspective view of a midfacial skeletal expander device, according to an embodiment of the present invention.

[0029] FIG. 2 exemplarily illustrates an exploded view of the midfacial skeletal expander device of FIG. 1.

[0030] FIG. 3 exemplarily illustrates a perspective view of an expander body of FIG. 1.

[0031] FIG. 4 exemplarily illustrates a side view of the midfacial skeletal expander device of FIG. 1.

[0032] FIG. 5 exemplarily illustrates a front side view of the midfacial skeletal expander device of FIG. 1.

[0033] FIG. 6 exemplarily illustrates a top view of the midfacial skeletal expander device of FIG. 1.

[0034] FIG. 7 exemplarily illustrates a bottom view of the midfacial skeletal expander device of FIG. 1.

[0035] FIG. 8 exemplarily illustrates a bottom perspective view of the midfacial skeletal expander device of FIG. 1.

[0036] FIG. 9 exemplarily illustrates a perspective view of a midfacial skeletal expander device, according to another embodiment of the present invention.

[0037] FIG. 10 exemplarily illustrates an exploded view of the midfacial skeletal expander device of FIG. 9.

[0038] FIG. 11 exemplarily illustrates a front side view of the midfacial skeletal expander device of FIG. 9.

[0039] FIG. 12 exemplarily illustrates a side view of the midfacial skeletal expander device of FIG. 9.

[0040] FIG. 13 exemplarily illustrates a top view of the midfacial skeletal expander device of FIG. 9.

[0041] FIG. 14 exemplarily illustrates a bottom view of the midfacial skeletal expander device of FIG. 9.

[0042] FIG. 15 exemplarily illustrates a bottom perspective view of the midfacial skeletal expander device of FIG. 9

[0043] FIG. 16 exemplarily illustrates a top perspective view of a midfacial skeletal expander device, according to another embodiment of the present invention.

[0044] FIG. 17 exemplarily illustrates a bottom perspective view of a midfacial skeletal expander device of FIG. 16.

[0045] FIG. 18 exemplarily illustrates an exploded view of a midfacial skeletal expander device of FIG. 16.

[0046] FIG. 19 exemplarily illustrates a perspective view of a midfacial expander device, according to an embodiment of the present invention.

[0047] FIG. 20 exemplarily illustrates an exploded view of the midfacial expander device of FIG. 19.

[0048] FIG. 21 exemplarily illustrates a top view of the midfacial expander device of FIG. 19.

[0049] FIG. 22 exemplarily illustrates a bottom perspective view of the midfacial expander device of FIG. 19.

[0050] FIG. 23 exemplarily illustrates a top perspective view of the midfacial expander device of FIG. 19 in expanded configuration.

[0051] FIG. 24 exemplarily illustrates a perspective view of a midfacial expander device, according to another embodiment of the present invention.

[0052] FIG. 25 exemplarily illustrates an exploded view of the midfacial expander device of FIG. 24.

[0053] FIG. 26 exemplarily illustrates a top perspective view of the midfacial expander device of FIG. 24.

[0054] FIG. 27 exemplarily illustrates a bottom perspective view of the midfacial expander device of FIG. 24.

[0055] FIG. 28 exemplarily illustrates a top perspective view of the midfacial expander device of FIG. 24.

[0056] FIG. 29 exemplarily illustrates a perspective view of a midfacial expander device, according to yet another embodiment of the present invention.

[0057] FIG. 30 exemplarily illustrates an exploded view of the midfacial expander device of FIG. 29.

[0058] FIG. 31 exemplarily illustrates a top view of the midfacial expander device of FIG. 29.

[0059] FIG. 32 exemplarily illustrates a bottom perspective of the midfacial expander device of FIG. 29.

[0060] FIG. 33 exemplarily illustrates a top perspective view of the midfacial expander device of FIG. 29.

[0061] FIG. 34 exemplarily illustrates a perspective of a midfacial expander device, according to yet another embodiment of the present invention.

[0062] FIG. 35 exemplarily illustrates a bottom perspective of the midfacial expander device of FIG. 34.

[0063] FIG. 36 exemplarily illustrates a top perspective of the midfacial expander device of FIG. 34 in expanded configuration.

[0064] FIG. 37 exemplarily illustrates a perspective of a midfacial expander device, according to yet another embodiment of the present invention.

[0065] FIG. 38 exemplarily illustrates a bottom perspective of the midfacial expander device of FIG. 37.

[0066] FIG. 39 exemplarily illustrates a top perspective of the midfacial expander device of FIG. 37 in expanded configuration.

[0067] FIG. 40 exemplarily illustrates a perspective of a midfacial expander device, according to yet another embodiment of the present invention.

[0068] FIG. 41 exemplarily illustrates a bottom perspective of the midfacial expander device of FIG. 40.

[0069] FIG. 42 exemplarily illustrates a top perspective of the midfacial expander device of FIG. 40 in expanded configuration.

[0070] FIG. 43 exemplarily illustrates a top perspective view of a midfacial expander device, according to yet another embodiment of the present invention.

[0071] FIG. 44 exemplarily illustrates a top view of the midfacial expander device of FIG. 43.

[0072] FIG. 45 exemplarily illustrates a bottom perspective view of the midfacial expander device of FIG. 43.

[0073] FIG. 46 exemplarily illustrates an exploded perspective view of the midfacial expander device of FIG. 43.

[0074] FIG. 47 exemplarily illustrates a top perspective view of a midfacial expander device, according to yet another embodiment of the present invention.

[0075] FIG. 48 exemplarily illustrates a top view of the midfacial expander device of FIG. 47.

[0076] FIG. 49 exemplarily illustrates a bottom perspective view of the midfacial expander device of FIG. 47.

[0077] FIG. 50 exemplarily illustrates an exploded perspective view of the midfacial expander device of FIG. 47.DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

[0078] A description of embodiments of the present invention will now be given with reference to the Figures. It is expected that the present invention may be embodied inother specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The present invention is versatile and can be effectively employed or used with any type of adjustable expanders. These expanders encompass various types, including but not limited to telescopic expansion screws and vertical expansion screws.

[0079] Referring to FIG. 1 and FIG. 2, the present invention discloses a midfacial expander device 100 with temporary anchorage devices (TADs) (146, 138A-138F). The device 100 comprises at least eight TADs (146, 138A-138F). The device 100 comprises a first expander body 102 and a second expander body 104. The first expander body 102 comprises a first sleeve 106 A and a first alignment rod 108 A. The second expander body 104 comprises a second alignment rod 108B and a second sleeve 106B. The first sleeve 106 A is arranged to receive the second alignment rod 108B and the second sleeve 106B is arranged to receive the first alignment rod 108 A.

[0080] In one embodiment, the sleeves (106A, 106B) of the device 100 have a squareshaped cross-section and alignment rods (108A, 108B) of the device 100 have a circularshaped cross-section. The sleeves (106A, 106B) and alignment rods (108A, 108B) may have any shape. In another embodiment, sleeves (106A, 106B) and alignment rods (108A, 108B) may have a pentagon shape or a hexagon shape.

[0081] The first expander body 102 comprises a first threaded hole 110 and the second expander body 104 comprises a second threaded hole 112. The first threaded hole 110 is formed such that an axis of the first threaded hole 110 is parallel to an axis of the first alignment rod 108 A. The second threaded hole 112 is formed such that an axis of the second threaded hole 112 is parallel to an axis of the second alignment rod 108B. The first threaded hole 110 and the second threaded hole 112 lie on a same axis.

[0082] The device 100 further comprises an expansion screw assembly 114. The expansion screw assembly 114 comprises an intermediate activation member 116. The intermediate activation member 116 further comprises at least one taper portion (118, 120) extending from each side of the intermediate activation member 116. A first threaded portion 122 extends from the taper portion 118 at a first side of the intermediate activation member 116 and a second threaded portion 124 extends from the taper portion 120 at a second side of the intermediate activation member 116. The first side is opposite to the second side of the intermediate activation member 116. The first threaded portion 122 is received within the first threaded hole 110 and the second threaded portion 124 is received within the second threaded hole 112. The expansion screw assembly 114 is activated using an activation wrench. The intermediate activation member 116 has a hexagon shape. In another embodiment, the intermediate activation member 116 may have any other shapes, which fall under the scope of this invention.

[0083] The device 100 further comprises a first anchor body 126 and a second anchor body 128. The first expander body 102 is mounted over the first anchor body 126 and the second expander body 104 is mounted over the second anchor body 128. One or more assembly screws (130A, I 30B, 130C, 1300) fasten the first expander body 102 over the first anchor body 126 and the second expander body 104 over the second anchor body 128.

[0084] The first expander body 102 comprises one or more first assembly holes (132A, 132B) and the first anchor body 126 comprises one or more second assembly holes (132C, 132D). One or more assembly screws (BOA, I 30B) fasten the first expander body 102 to the first anchor body 126 via one or more first assembly holes (132A, 132B) and one or more second assembly holes (132C, 132D). The second expander body 104 comprises one or more first assembly holes (136A, 136B) and the second anchor body 128 comprises one or more second assembly holes (136C, 136D). One or more assemblyscrews (130C, 130D) fasten the second expander body 104 to the second anchor body 128 via one or more first assembly holes (136A, 136B) and one or more second assembly holes (136C, 136D).

[0085] In another embodiment, the expander body (102, 108) is mounted to the anchor body (126, 128) by any other conventional fastening means. In one embodiment, the alignment rods (108 A, 108B) are configured to telescope through the sleeves (106 A, 106B). In one embodiment, the alignment rods (108A, 108B) are press fit to the respective expander body (102, 108). In another embodiment, the alignment rods (108A, 108B) integrally extend from the respective expander body (102, 104). Further, one or more anchor screws (138A, 138B, 138C, 138D, 138E, 138F) extend from the first anchor body 126 and the second anchor body 128 to attach the device 100 to the maxilla of a patient. Optionally the device 100 may or may not include molar attachments to the teeth or attachments to the side palate. The anchor screws (138 A, 138B, 138C, 138D, 138E, 138F) are also a TAD.

[0086] Referring to FIG. 1, FIG. 2 and FIG. 6, in one embodiment, the first anchor body 126 comprises a first base portion 170 and a first anchorage support portion or first support portion 172. The first base portion 170 comprises a first side, a second side opposite to the first side, a third side and a fourth side opposite to the third side. The first support portion 172 comprises a front support portion extends from the first side and a side support portion extends from the third side. The first anchorage support portion 172 extends perpendicular to the base portion 170 towards the first expander body 102. The first anchorage support portion 172 extends to conform to a front portion and a corner portion of the first expander body 102.

[0087] In one embodiment, the second anchor body 128 comprises a second base portion 174 and a second anchorage support portion or second support portion 176. Thesecond base portion 174 comprises a first side, a second side opposite to the first side, a third side and a fourth side opposite to the third side. The second support portion 176 comprises a front support portion extends from the first side and a side support portion extends from the third side. The second anchorage support portion 176 extends perpendicular to the base portion 174 towards the second expander body 104. The second anchorage support portion 176 extends to conform a front portion of the second expander body 104. The first anchorage support portion 172 and second anchorage support portion 176 lie on a side of the device 100. Each anchorage support portion (172, 176) comprises a threaded hole (178, 182). The threaded hole (178, 182) receives respective anchorage screws or temporary anchorage devices 146.

[0088] Further, one or more side support portions 186 extends from the third side of each base portion (170, 174) of each anchor body (126, 128). The support portion 186 extends perpendicular to the base portion (170, 174) and towards respective expander body (102, 103).

[0089] Referring to FIG. 2 to FIG. 5 and FIG. 6 to FIG. 8, the device 100 comprises at least two first blocks (150A, 150B). At least one first block 150A extends perpendicularly from a midportion of the first sleeve 106 A and at least one first block 150B extends perpendicularly from a midportion of the second sleeve 106B.

[0090] Referring to FIG. 4 and FIG. 8, the first expander body 102 mounted over the first anchor body 126 and the second expander body 104 mounted over the second anchor body 128. Further, the first threaded portion 122 and the second threaded portion 124 of the expansion screw assembly 114, and the first alignment road 108 A and the second alignment rod 108B passing through the expander body (102, 104). Further, the anchorage support portion (172, 176) supports respective temporary anchorage devices 146.

[0091] Referring FIG. 7 and FIG. 8, one or more anchor screws (138A, 138B, 138C, 138D, 138E, 138F) extend from the first anchor body 126 and the second anchor body 128 to attach the device 100 to the maxilla of a patient.

[0092] Referring to FIG. 9 and FIG. 10, the present invention discloses a patientspecific midfacial expander device 200 with temporary anchorage devices (TADs) (146, 138A-138F), according to another embodiment of the present invention. The device 100 comprises at least twelve TADs (146, 138A-138F). The midfacial expander device 200 is a customizable unibody, midfacial expander device 200. The device 200 comprises at least ten temporary anchorage devices (TAD) 146, which perfectly matches the palatal anatomy soft palate / uvula curve in the back and anterior palate curve in the front. The device 200 comprises a first expander body 102 and a second expander body 104. The first expander body 102 comprises a first sleeve 106A and a first alignment rod 108A. The second expander body 104 comprises a second alignment rod 108B and a second sleeve 106B. The first sleeve 106 A is arranged to receive the second alignment rod 108B and the second sleeve 106B is arranged to receive the first alignment rod 108 A. In one embodiment, each alignment rod (108 A, 108B) comprises a flange, which is welded to respective expander body (102, 104). The components may not be joined through welding; instead, they are machined or crafted as a singular, seamless unit to achieve the utmost level of structural integrity. Although, from a technical standpoint, welding could be an option, the current manufacturing process prioritizes a single-piece construction method, ensuring superior strength and durability. In one embodiment, the sleeves (106A, 106B) of the device 200 have a square-shaped cross-section and alignment rods (108A, 108B) of the device 200 have a circular- shaped cross-section. The sleeves (106A, 106B) and alignment rods (108A, 108B) may have any shape. In another embodiment, sleeves (106A, 106B) and alignment rods (108A, 108B) may have a pentagon shape or a hexagon shape.

[0093] The first expander body 102 comprises a first threaded hole 110 and the second expander body 104 comprises a second threaded hole 112. The first threaded hole 110 is formed such that an axis of the first threaded hole 110 is parallel to an axis of the first alignment rod 108 A. The second threaded hole 112 is formed such that an axis of the second threaded hole 112 is parallel to an axis of the second alignment rod 108B. The first threaded hole 110 and the second threaded hole 112 lie on a same axis.

[0094] The device 200 further comprises an expansion screw assembly 114. The expansion screw assembly 114 comprises an intermediate activation member 116. The intermediate activation member 116 further comprises at least one taper portion (118, 120) extending from each side of the intermediate activation member 116. A first threaded portion 122 extends from the taper portion 118 at a first side of the intermediate activation member 116 and a second threaded portion 124 extends from the taper portion 120 at a second side of the intermediate activation member 116. The first side is opposite to the second side of the intermediate activation member 116. The first threaded portion 122 is received within the first threaded hole 110 and the second threaded portion 124 is received within the second threaded hole 112. The expansion screw assembly 114 is activated using an activation wrench. The intermediate activation member 116 has a hexagon shape. In another embodiment, the intermediate activation member 116 may have any other shapes, which fall under the scope of this invention.

[0095] In another embodiment, the intermediate activation member 116 comprises at least two taper portions extending from each side of the intermediate activation member 116, and the first and second threaded portion (122, 124) extends from the taper portions from each side of the intermediate activation member 116. The device 200 further comprises a first anchor body 126 and a second anchor body 128. The first expander body 102 is mounted over the first anchor body 126 and the second expander body 104is mounted over the second anchor body 128. One or more assembly screws (BOA, BOB, 130C, BOD) fasten the first expander body 102 over the first anchor body 126 and the second expander body 104 over the second anchor body 128.

[0096] The first expander body 102 comprises one or more first assembly holes (132A, 132B) and the first anchor body 126 comprises one or more second assembly holes (132C, 132D). One or more assembly screws (BOA, BOB) fasten the first expander body 102 to the first anchor body 126 via one or more first assembly holes (B2A, B2B) and one or more second assembly holes (132C, 132D). The second expander body 104 comprises one or more first assembly holes (136A, 136B) and the second anchor body 128 comprises one or more second assembly holes (136C, 136D). One or more assembly screws (130C, BOD) fasten the second expander body 104 to the second anchor body 128 via one or more first assembly holes (136A, 136B) and one or more second assembly holes (136C, 136D).

[0097] In another embodiment, the expander body (102, 108) is mounted to the anchor body (126, 128) by any other conventional fastening means. In one embodiment, the alignment rods (108 A, 108B) are configured to telescope through the sleeves (106 A, 106B). In one embodiment, the alignment rods (108A, 108B) are press fit to the respective expander body (102, 108). In another embodiment, the alignment rods (108A, 108B) integrally extend from the respective expander body (102, 104). Further, one or more anchor screws (138A, 138B, 138C, 138D, 138E, 138F) extend from the first anchor body 126 and the second anchor body 128 to attach the device 200 to the maxilla of a patient. Optionally the device 200 may or may not include molar attachments to the teeth or attachments to the side palate. The anchor screws (138 A, 138B, 138C, 138D, 138E, 138F) are also a TAD.

[0098] Referring to FIG. 10 to FIG. 15, in one embodiment, the first anchor body 126 comprises a first base portion 170 and a first anchorage support portion or first support portion 172. The first base portion 170 comprises a first side, a second side opposite to the first side, a third side and a fourth side opposite to the third side. The first support portion 172 comprises a front support portion extends from the first side and a side support portion extends from the third side. The first anchorage support portion 172 extends perpendicular to the base portion 170 towards the first expander body 102. The first anchorage support portion 172 extends to conform to a front portion and a corner portion of the first expander body 102.

[0099] In one embodiment, the second anchor body 128 comprises a second base portion 174 and a second anchorage support portion or second support portion 176. The second base portion 174 comprises a first side, a second side opposite to the first side, a third side and a fourth side opposite to the third side. The second support portion 176 comprises a front support portion extends from the first side and a side support portion extends from the third side. The second anchorage support portion 176 extends perpendicular to the base portion 174 towards the second expander body 104. The second anchorage support portion 176 extends to conform a front portion of the second expander body 104. The first anchorage support portion 172 and second anchorage support portion 176 lie on a side of the device 100. Each anchorage support portion (172, 176) comprises a threaded hole (178, 182). The threaded hole (178, 182) receives respective temporary anchorage devices 146.

[0100] Further, one or more side support portions 186 extends from the third side of each base portion (170, 174) of each anchor body (126, 128). The support portion 186 extends perpendicular to the base portion (170, 174) and towards respective expander body (102, 103).

[0101] Referring to FIG. 10 to FIG. 12, FIG. 13 and FIG. 14, the device 200 further comprises at least two first blocks (150A, 150B). At least one first block 150A extends perpendicularly from a midportion of the first sleeve 106 A and at least one first block 150B extends perpendicularly from a midportion of the second sleeve 106B. The blocks (150A, 150B) are configured to massively resist the shear force from midfacial expansion.

[0102] In one embodiment, the blocks (150A, 150B) exhibit diverse geometries (could be of any shape) and are purposefully structured to counteract or resist any tendency for the anchor bodies or Temporary Anchorage Devices (TAD) 146 to tilt during the progress of expansion process. These blocks (150A, 150B) possess a design that effectively opposes or resist both shear forces and bending moments arising from the application of midfacial expansion. In various embodiments of the present invention, the material added to the blocks (150A, 150B) acts to provide a counter-reactionary force during midfacial expansion. By virtue of this inherent characteristic, the TAD 146 and / or anchor bodies (126, 128) can maintain an entirely linear orientation (can remain totally straight, and not tilted), devoid of any inclination, throughout the midfacial expansion phase. This preservation of alignment ensures that the screws remain stable and fixed at the appropriate angle within the bone throughout the expansion process, contributing to the achievement of the most optimal clinical outcomes.

[0103] Referring to FIG. 10 to FIG. 15, the first expander body 102 mounted over the first anchor body 126, the second expander body 104 mounted over the second anchor body 128 and the intermediate activation member 116 to activate the expansion screw assembly 114 (shown in FIG. 10) extending between the first expander body 102 and the second expander body 104. The first expander body 102 is mounted over the first anchor body 126 and the second expander body 104 is mounted over the second anchor body 128. The support members (142, 144) are configured to support respectivetemporary anchorage devices (TAD) 146. Further, one or more anchor screws (138A, 138B, 138C, 138D, 138E, 138F) extend from the first anchor body 126 and the second anchor body 128 to attach the device 200 to the maxilla of a patient.

[0104] Referring to FIG. 9 to FIG. 15, the device 200 comprises one or more temporary anchorage assemblies 140. The temporary anchorage assemblies 140 are fixed to the device 200 via at least two support members (142, 144). The support members (142, 144) include a first support member 142 and a second support member 144. The first support member 142 is attached to the first anchor body 126. The second support member 144 is attached to the second anchor body 128. The first support member 142 and the second support member 144 are attached at the exterior side of the respective first anchor body 126 and the second anchor body 128. The body of the support members (142, 144) are designed and configured to support the temporary anchorage assemblies 140 at an angle with respect to the expander body (102, 104) and anchor body (126, 128) of the device 200. Referring to FIG. 10, the device 200 further comprises one or more flange members 164. The flange members 164 extends from the exterior side of the first anchor body 126 and the second anchor body 128. Further, each support members (142, 144) comprises one or more holes 166, which facilitates the support members (142, 144) to fix over respective flange member 164. The flange members 164 on the anchor bodies (126, 128) allow for unibody strength with the custom part comprising the support members (142, 144). The flange members 164 can be in multiple configurations and shapes and allows a seamless weld of custom part with extreme strength. The components may not be joined through welding; instead, they are machined or crafted as a singular, seamless unit to achieve the utmost level of structural integrity. Although, from a technical standpoint, welding could be an option, the current manufacturing process prioritizes a single-piece construction method, ensuring superior strength and durability.

[0105] Each support member (142, 144) is configured to support at least two temporary anchorage assemblies 140. Each temporary anchorage assembly 140 comprises one or more temporary anchorage devices (TAD) 146. The temporary anchorage device 146 is a temporary anchorage screw 146. The temporary anchorage assembly 140 comprises one or more hollow locking members 148. Each hollow locking member 148 comprises a cylindrical portion. The cylindrical portion comprises a plurality of first threads 152 at an interior side of the cylindrical portion. The support member 142 is configured to support at least two temporary anchorage assembly 140.

[0106] The temporary anchorage screw 146 comprises a head portion having a plurality of second threads 156 at an exterior surface of the head portion. The second threads 156 extend along at least a portion of the head portion. The temporary anchorage screw 146 is configured to lock with the hollow locking member 148 as the second threads 156 of the temporary anchorage screw 146 screws over the first threads 152 of the hollow locking member 148. Further, each hollow locking member 148 comprises a flange. The device 200 comprises flange members 164 or could have any other coupling mechanism, which could facilitate a strong welding connection of the support members (142, 144) to the first and second anchor body (126, 128).

[0107] The device 200 further comprises one or more predrill abutment tube member (herein after referred as tube member). The tube member comprises a plurality of third threads at an exterior surface of tube member. The tube member is configured to lock with the respective hollow locking member 148. The third threads of the tube member thread over at least a portion of the first threads 152 of the hollow locking member 148, thereby locking the tube member with the respective hollow locking member 148. The tube member is used to guide a pilot drill. During application of the device 200, the tube member is screwed to the hollow locking member 148 to guide the pilot drill. Thereafter,the tube member is removed from the device 200 and the TADs 146 are positioned and locked with the hollow locking member 148.

[0108] The placement of the TAD 146 could be customized and locked in position with full strength. The device 200 is a unibody custom midfacial expander. During operation, the temporary anchorage devices (TAD) 146 are inserted into the palatal bone. The temporary anchorage devices 146 locked to the hollow locking member 148 ensures angular stability between the device 200 and the bone. The device 200 provides expansive forces to the TAD 146 in order to split the palate.

[0109] The dental lab or similar facility could position the temporary anchorage assembly 140 in a guide surgery software. After the position of the TAD 146 is finalized in a position that ensures the best bone anchorage and location, preferably bi or tricortical anchorage, a custom part, for example, the support members (142, 144) are printed. The custom part is made of, for example, materials including, but not limited to, grade 23 titanium, cobalt chrome and steel. The custom part secures the temporary anchorage assembly 140 securely.

[0110] The present invention could use 3-dimensional computer-aided design and computer-aided manufacturing (3D CAD CAM) in conjunction with at least one process, including, but not limited to, milling and printing process to manufacture and for placement of one or more components of the device 200 including, but not limited to, the temporary anchorage assembly 140 and the support members (142, 144). The use of a locking member 148 with internal threads allows custom 3D CAD CAM manufacturing and guided surgery planning of precise locations in the palate for the patient. Then with the locking member 148 secured inside the CAD CAM metal part, ideally with a flange included, followed by laser weld, an extremely strong connection could be formed, resulting in a unibody, custom midfacial expander device 200.

[0111] The TADs 146 and the screws (138A, 138B, 138C, 138D) provide an optimal configuration to transfer all the force in the posterior palate against the biozygomatic line for the best parallel midfacial expansion results. The TAD 146 is ideally and precisely inserted into the tricortical anchorage area in the palate. Other configurations of placement of TAD 146 and the design of device 200 are within the scope of this invention, including the use of not stacked bodies and the use of telescopic-style expander. For example, one embodiment of the present invention would be custom positioning TADs 146 for a patient during planning based on their radiography / cone beam computed tomography (CBCT) records, then to print / mill a custom part or support members (142, 144) for the locking tube abutments or locking member 148 to fit inside the support members (142, 144). After adding the locking tube abutments to the custom part, any expander could be attached or welded to the custom parts to provide expansive force and push the bodies away from each other. This more primitive embodiment is within the scope of the present invention.

[0112] The tube member also referred as predrill abutments are locked into the locking member 148 to facilitate a strong alignment predrill for the TAD 146, which ensures precision placement of the TAD 146 to match the guided surgery and prevent any deviations that could potentially harm critical structures such as the neurovascular bundle. The expander device 200 comprises custom placed TADs 146 and locked in position with full strength.

[0113] Referring to FIG. 16 to FIG. 18, the present invention discloses a midfacial expander device 300. The device 300 comprises at least ten TADs (146, 138A - 138F). The device 300 comprises a first expander body 102 and a second expander body 104. The first expander body 102 comprises a first sleeve 106 A and a first alignment rod 108 A. The second expander body 104 comprises a second alignment rod 108B and asecond sleeve 106B. The first sleeve 106 A is arranged to receive the second alignment rod 108B and the second sleeve 106B is arranged to receive the first alignment rod 108A.

[0114] In one embodiment, the sleeves (106A, 106B) of the device 300 have a squareshaped cross-section and alignment rods (108A, 108B) of the device 300 have a circularshaped cross-section. The sleeves (106A, 106B) and alignment rods (108A, 108B) may have any shape. In another embodiment, sleeves (106A, 106B) and alignment rods (108A, 108B) may have a pentagon shape or a hexagon shape.

[0115] The first expander body 102 comprises a first threaded hole 110 and the second expander body 104 comprises a second threaded hole 112. The first threaded hole 110 is formed such that an axis of the first threaded hole 110 is parallel to an axis of the first alignment rod 108 A. The second threaded hole 112 is formed such that an axis of the second threaded hole 112 is parallel to an axis of the second alignment rod 108B. The first threaded hole 110 and the second threaded hole 112 lie on a same axis.

[0116] The device 300 further comprises an expansion screw assembly 114. The expansion screw assembly 114 comprises an intermediate activation member 116. The intermediate activation member 116 further comprises at least one taper portion (118, 120) extending from each side of the intermediate activation member 116. A first threaded portion 122 extends from the taper portion 118 at a first side of the intermediate activation member 116 and a second threaded portion 124 extends from the taper portion 120 at a second side of the intermediate activation member 116. The first side is opposite to the second side of the intermediate activation member 116. The first threaded portion 122 is received within the first threaded hole 110 and the second threaded portion 124 is received within the second threaded hole 112. The expansion screw assembly 114 is activated using an activation wrench. The intermediate activation member 116 has ahexagon shape. In another embodiment, the intermediate activation member 116 may have any other shapes, which fall under the scope of this invention.

[0117] The device 300 further comprises a first anchor body 126 and a second anchor body 128. The first expander body 102 is mounted over the first anchor body 126 and the second expander body 104 is mounted over the second anchor body 128. One or more assembly screws (130A, I 30B, 130C, BOD) fasten the first expander body 102 over the first anchor body 126 and the second expander body 104 over the second anchor body 128.

[0118] The first expander body 102 comprises one or more first assembly holes (132A, 132B) and the first anchor body 126 comprises one or more second assembly holes (132C, 132D). One or more assembly screws (BOA, BOB) fasten the first expander body 102 to the first anchor body 126 via one or more first assembly holes (132A, 132B) and one or more second assembly holes (132C, 132D). The second expander body 104 comprises one or more first assembly holes (136A, 136B) and the second anchor body 128 comprises one or more second assembly holes (136C, 136D). One or more assembly screws (130C, BOD) fasten the second expander body 104 to the second anchor body 128 via one or more first assembly holes ( 136A, 136B) and one or more second assembly holes (136C, 136D).

[0119] In another embodiment, the expander body (102, 108) is mounted to the anchor body (126, 128) by any other conventional fastening means. In one embodiment, the alignment rods (108 A, 108B) are configured to telescope through the sleeves (106 A, 106B). In one embodiment, the alignment rods (108A, 108B) are press fit to the respective expander body (102, 108). In another embodiment, the alignment rods (108A, 108B) integrally extend from the respective expander body (102, 104). Further, one or more anchor screws (138A, 138B, 138C, 138D, 138E, 138F) extend from the firstanchor body 126 and the second anchor body 128 to attach the device 100 to the maxilla of a patient. The anchor screws (138A, 138B, 138C, 138D, 138E, 138F) are also a TAD. Optionally the device 100 may or may not include molar attachments to the teeth or attachments to the side palate.

[0120] Each anchor body (126, 128) comprises a base portion (170, 174) and a support portion (172, 176). The first anchor body 126 comprises a first base portion 170 and the second anchor body 128 comprises a second base portion 174. The first anchor body 126 comprises a first support portion 172 and the second anchor body 128 comprises a second support portion 176.

[0121] Each base portion (170, 174) comprises a first side or a front side, a second side or a rear side opposite to the first side, a third side or the outer side and a fourth side or an interior side opposite to the third side. Each support portion (172, 176) and the base portion (170, 174) defines a first cavity and a second cavity to receive the first base and second base of the first expander body 102 and the second expander body 104, respectively. Each support portion (172, 176) comprises a front support portion, a side support portion and a rear support portion. The front support portion extends from the first side of the respective base portion (170, 174) and the side support portion extends from the third side of the respective base portion (170, 174). The side support portion comprises one or more spaces or gaps to allow passage of alignment rods (108A, 108B) and sleeves (106 A, 106B). The rear support portion extends from the second side of the respective base portion (170, 174).

[0122] The front support portion of the first anchor body 126 extends to conform to a front portion and a corner portion of the first expander body 102. The rear support portion of the first anchor body 126 extends to conform to a rear portion of the first expander body 102.

[0123] The front support portion of the second anchor body 128 extends to conform a front portion of the second expander body 104. The rear support portion of the second anchor body 128 extends to conform a rear portion and a rear corner portion of the second expander body 104. Each front support portion and rear support portion comprises a threaded hole (178, 182, 192, 194). The threaded hole (178, 182) receives respective anchorage screws or temporary anchorage devices 146.

[0124] The device 300 comprises at least two first blocks (150A, 150B). At least one first block 150A extends perpendicularly from a midportion of the first sleeve 106 A and at least one first block 150B extends perpendicularly from a midportion of the second sleeve 106B.

[0125] The device 100 covers the entire length to the posterior palatal bone. The device 200 comprises at least ten temporary anchorage devices (TAD) 146, which perfectly matches the palatal anatomy soft palate / uvula curve in the back and anterior palate curve in the front. The device 200 is configured to apply expansion force from the palatine bone in the posterior all the way to the point just behind the nasopalatine canal. The device 200 has equal spacing of all the screws for even force distribution. The flanges 164 provide "side support" for the entire length of the anchor body preventing tooth and dentoalveolar / periodontal damages. The additional TADs 146 of the device (100, 200, 300) are delicately configured such that the additional TADs 146 are evenly spaced apart, and critically / fundamentally, that the device (100, 200, 300) could fit in the human palate like a glove. Fundamentally, human palate is straight in the posterior and then slanted towards the anterior palate slope. Here, the device (100, 200, 300) creates a stacked layer of TADs allowing it to be placed precisely / perfectly to derive anchorage. The TADs 146 are perfectly spaced apart and perfectly distributed along the length of the midpalate and posterior palate, all before the nasopalatine canal.

[0126] Referring to FIG. 19 to FIG. 23, a midfacial expander device 400 comprises a first expander body 202 and a second expander body 204. The first expander body 202 comprises a first base 206A having a first side and a second side opposite to the first side. The first expander body 202 further comprises a first sleeve 208A extending from the first side of the first base 206A. The first expander body 202 further comprises a first alignment rod 210A extends from the second side of the first base 206A. The first sleeve 208 A is parallel to the first alignment rod 210A.

[0127] The second expander body 204 comprises a second base 206B having a first side and a second side opposite to the first side. The second expander body 204 further comprises a second sleeve 208B extending from the second side of the second base 206B. The second expander body 204 further comprises a second alignment rod 210B extending from the first side of the second base 206B. The second sleeve 206B is parallel to the second alignment rod 210B.

[0128] The first base 206A further comprises a first threaded hole 224. The second base 106B further comprises a second threaded hole 226. The second threaded hole 226 is coaxial to the first threaded hole 224 and parallel to an axis of the alignment rods (210A, 210B).

[0129] The first sleeve 208 A is arranged to receive the second alignment rod 210B and the second sleeve 206B is arranged to receive the first alignment rod 210A. In one embodiment, the sleeves (208A, 208B) of the device 400 have a square-shaped crosssection and alignment rods (10A, 110B) of the device 100 have a circular-shaped crosssection. The sleeves (208A, 208B) and alignment rods (210A, 210B) may have any shape. In another embodiment, the alignment rods (210A, 210B) may have a pentagon shape or a hexagon shape.

[0130] The midfacial expander device 400 further comprises a first anchor body 230A and a second anchor body 230B. The first anchor body 230A comprises a first base portion 238 A and a first support portion 238B. The first base portion 238 A comprises an outer side. The outer side refers to an exposed side of the midfacial expander device 400. The first support portion 238B extends from the outer side and extends perpendicular to the first base portion 238A towards the first expander body 202. The first support portion 238B extends to conform at least a portion of the first expander body 202 and the second expander body 204.

[0131] The second anchor body 230B comprises a second base portion 240A and a second support portion 240B. The second base portion 240A comprises an outer side. The outer side refers to an exposed side of the midfacial expander device 400. The second support portion 240B extends from the outer side and extends perpendicular to the second base portion 240A towards the second expander body 204. The second support portion 240B extends to conform at least a portion of the first expander body 202 and the second expander body 204.

[0132] Each base portion (238A, 240A) comprises a first side or a front side, a second side or a rear side opposite to the first side, a third side or the outer side and a fourth side or an interior side opposite to the third side. Each support portion (238B, 240B) and the base portion (238 A, 240 A) defines a first cavity and a second cavity to receive the first base 106A and second base 106B of the first expander body 102 and the second expander body 104, respectively. Each support portion (238B, 240B) comprises a front support portion and a side support portion. The front support portion extends from the first side of the respective base portion (238 A, 240 A) and the side support portion extends from the third side of the respective base portion (238 A, 240 A). The sidesupport portion comprises one or more spaces to allow passage of alignment rods (110A, HOB) and sleeves (108A, 108B).

[0133] The first support portion 238B at the front and rear side of the first anchor body 230A comprises holes 242 to receive one or more protraction wires. Further, the second support portion 240B at the front and rear side of the second anchor body 230B comprises holes 242 to receive one or more protraction wires.

[0134] The device 400 further comprises an expansion screw assembly 212. The expansion screw assembly 212 comprises an intermediate activation member 214. The intermediate activation member 214 further comprises at least two taper portions extending from each side of the intermediate activation member 214. A first threaded portion 220 extends from the taper portion at a first side of the intermediate activation member 214 and a second threaded portion 222 extends from the taper portion at a second side of the intermediate activation member 214. The first side is opposite to the second side of the intermediate activation member 214. The first threaded portion 120 is received within the first threaded hole 224 and the second threaded portion 222 is received within the second threaded hole 226. The expansion screw assembly 212 is activated using an activation wrench.

[0135] Further, the first expander body 202 is mounted over the first anchor body 230A and the second expander body 204 is mounted over the second anchor body 230B. One or more assembly screws (228A, 228B, 228C, 228D) fastens the first expander body 202 over the first anchor body 230A and the second expander body 204 over the second anchor body 204. In one embodiment, the expansion screw assembly 212 is an adjustable expander. The expansion screw assembly 212 comprises any expansion mechanism that pushes the anchor bodies (230A, 230B) from one another. The expansion screw assembly 212 is an adjustable expander. The adjustable expander couldinclude at least one of different style of expanders, expansion screw styles, and expansion mechanisms.

[0136] The first expander body 202 comprises one or more first assembly holes and the first anchor body 230A comprises one or more second assembly holes. One or more assembly screws (228A, 228B) fasten the first expander body 202 to the first anchor body 230A via one or more first assembly holes and one or more second assembly holes. The second expander body 204 comprises one or more first assembly holes and the second anchor body 230B comprises one or more second assembly holes. One or more assembly screws (228C, 228D) fasten the second expander body 204 to the second anchor body 230B via one or more first assembly holes and one or more second assembly holes. Other coupling mechanisms of the adjustable expander to the anchor body are within the scope of this invention, including compression force, interference, clamping, welding, rivets, etc.

[0137] Further, one or more bone anchor screws (232A, 232B, 232C, 232D, 232E, 232F) extend from the first anchor body 130A and the second anchor body 230B to attach the device 400 to the maxilla of a patient, specifically the hard palate. Optionally the device 400 may or may not include molar attachments to the teeth or attachments to the side palate.

[0138] Referring to FIG. 24 to FIG. 28, a midfacial expander device 500 comprising the first and second expander body (202, 204), expansion screw assembly 214, bone anchor screws (232A, 232B, 232C, 232D, 232E, 232F) extending from the first anchor body 230A and the second anchor body 230B to either side of the hard palate of the maxilla, assembly screws (228C, 228D) fastening the second expander body 204 to the second anchor body 230B and assembly screws (228 A, 228B) fastening the first expander body 202 to the first anchor body 230A are same as that of the embodiment ofthe midfacial expander device 400. Thus, reference shall be made to the embodiment of the midfacial expander device 400 for understanding the mentioned components.

[0139] The midfacial expander device 500 is different from the midfacial expander device 400 with respect to the first anchor body 230A and the second anchor body 230B . The first anchor body 230A comprises a first anchorage portion 234A at a front side of the first anchor body 230A. The second anchor body 230B comprises a second anchorage portion 234B at a front side of the second anchor body 230B. The first anchorage portion 234A and the second anchorage portion 234B comprise anchorage screws 236. The two bone anchorage screws 236 and the bone anchor screws (232A, 232B, 232C, 232D, 232E, 232F) together define eight temporary anchorage devices (8- TAD). The first anchor body 230A and the second anchor body 230B further comprise holes 242 at a rear side of the respective anchor body (230A, 230B).

[0140] Referring to FIG. 29 to FIG. 33, a midfacial expander device 600 comprising the first and second expander body (202, 204), expansion screw assembly 214, bone anchor screws (232A, 232B, 232C, 232D, 232E, 232F) extending from the first anchor body 230A and the second anchor body 230B to either side of the hard palate of the maxilla, assembly screws (228C, 228D) fastening the second expander body 204 to the second anchor body 230B and assembly screws (228 A, 228B) fastening the first expander body 202 to the first anchor body 230A are same as that of the embodiment of the midfacial expander device 400. Thus, reference shall be made to the embodiment of the midfacial expander device 400 for understanding the mentioned components.

[0141] The midfacial expander device 600 is different from the midfacial expander device 400 with respect to the first anchor body 230A and the second anchor body 230B . The first anchor body 230A comprises at least two bone anchorage portions 234A at a front and rear side of the first anchor body 230A. The second anchor body 230Bcomprises at least two anchorage portions 234B, intended to receive locking bone anchorage screws 236, at the front and rear side of the second anchor body 230B. Each of the four anchorage portions (234A, 234B) comprises anchorage screws 236. The two bone anchorage screws 136 and the bone anchor screws (232A, 232B, 232C, 232D, 232E, 232F) together define ten temporary anchorage devices (10-TAD). The first anchor body 230A and the second anchor body 230B further comprise holes 242 to receive one or more protraction wires. The protraction wire is intended to have the function of applying extraoral advancement / protraction forces to the midfacial expander bone anchorage for the intention of pulling forward the upper jaw.

[0142] Referring to FIG. 34 to FIG. 36, a midfacial expander device 700 comprising the first and second expander body (202, 204), first and second anchor body (230A, 230B), bone anchor screws (232A, 232B, 232C, 232D, 232E, 232F) extending from the first anchor body 230A and the second anchor body 230B to the maxilla, assembly screws (228C, 228D) fastening the second expander body 204 to the second anchor body 230B, assembly screws (228A, 228B) fastening the first expander body 202 to the first anchor body 230A are same as that of the embodiment of the midfacial expander device 400. Thus, reference shall be made to the embodiment of the midfacial expander device 400 for understanding the mentioned components.

[0143] The device 700 further comprises an expansion screw assembly 250 having an intermediate activation member 244. The expansion screw assembly 250 is a telescopic adjustable expander. The intermediate activation member 244 extends between the first expander body 202 and the second expander body 204. A first threaded portion 246 extends from a first side of the intermediate activation member 244 and a second portion 248 extends from a second side of the intermediate activation member 244. The first side is opposite to the second side of the intermediate activation member 244. The first threaded portion 246 is received within the first threaded hole and the second portion248 is received within the second threaded hole. The intermediate activation member 244 comprises a first hollow threaded interior portion configured to receive the first threaded portion 246. The first threaded portion 246 comprises a second hollow threaded interior portion configured to receive the second portion 248. The expansion screw assembly 250 is activated using an activation wrench. The first threaded portion 246 and the second portion 248 threadably move within the intermediate activation member 244 to expand or retract the device 700.

[0144] Referring to FIG. 37 to FIG. 39, a midfacial expander device 800 comprising the first and second expander body (202, 204), first and second anchor body (230A, 230B), bone anchor screws (232A, 232B, 232C, 232D, 232E, 232F) extending from the first anchor body 230A and the second anchor body 230B to the maxilla, assembly screws (228C, 228D) fastening the second expander body 204 to the second anchor body 230B, assembly screws (228A, 228B) fastening the first expander body 202 to the first anchor body 230A are same as that of the embodiment of the midfacial expander device 500. Thus, reference shall be made to the embodiment of the midfacial expander device 500 for understanding the mentioned components.

[0145] The device 800 further comprises an expansion screw assembly 250 having an intermediate activation member 244. The expansion screw assembly 250 is a telescopic adjustable expander. The intermediate activation member 244 extends between the first expander body 202 and the second expander body 204. A first threaded portion 246 extends from a first side of the intermediate activation member 244 and a second portion 248 extends from a second side of the intermediate activation member 244. The first side is opposite to the second side of the intermediate activation member 244. The first threaded portion 246 is received within the first threaded hole and the second portion 248 is received within the second threaded hole. The intermediate activation member 244 comprises a first hollow threaded interior portion configured to receive the firstthreaded portion 246. The first threaded portion 246 comprises a second hollow threaded interior portion configured to receive the second portion 248. The expansion screw assembly 250 is activated using an activation wrench. The first threaded portion 246 and the second portion 248 threadably move within the intermediate activation member 244 to expand or retract the device 800.

[0146] Referring to FIG. 40 to FIG. 42, a midfacial expander device 900 comprising the first and second expander body (202, 204), first and second anchor body (230A, 230B), bone anchor screws (232A, 232B, 232C, 232D, 232E, 232F) extending from the first anchor body 230A and the second anchor body 230B to the maxilla, assembly screws (228C, 228D) fastening the second expander body 204 to the second anchor body 230B, assembly screws (228A, 228B) fastening the first expander body 202 to the first anchor body 230A are same as that of the embodiment of the midfacial expander device 600. Thus, reference shall be made to the embodiment of the midfacial expander device 600 for understanding the mentioned components.

[0147] The device 900 further comprises an expansion screw assembly 250 having an intermediate activation member 244. The expansion screw assembly 250 is a telescopic adjustable expander. The intermediate activation member 244 extends between the first expander body 202 and the second expander body 204. A first threaded portion 246 extends from a first side of the intermediate activation member 244 and a second portion 248 extends from a second side of the intermediate activation member 244. The first side is opposite to the second side of the intermediate activation member 244. The first threaded portion 246 is received within the first threaded hole and the second portion 248 is received within the second threaded hole. The intermediate activation member 244 comprises a first hollow threaded interior portion configured to receive the first threaded portion 246. The first threaded portion 246 comprises a second hollow threaded interior portion configured to receive the second portion 248. The expansion screwassembly 250 is activated using an activation wrench. The first threaded portion 246 and the second portion 248 threadably move within the intermediate activation member 244 to expand or retract the device 900.

[0148] Referring to FIG. 19 to FIG. 42, the device (400 to 900) further comprises at least two first blocks (250A, 250B). At least one first block 250A extends perpendicularly from a midportion of the first sleeve 208A and at least one first block 250B extends perpendicularly from a midportion of the second sleeve 208B. The first blocks (250A, 250B) are configured to massively resist the shear force from midfacial expansion. These first blocks (250A, 250B) possess a design that effectively opposes or resist both shear forces and bending moments arising from the application of midfacial expansion.

[0149] Referring to FIG. 19 to FIG. 42, the device (400 to 900) further comprises at least two inner flanges or second blocks (252A, 252B). The flanges (252A, 252B) also referred as second blocks. At least one flange 252 A extends from the first base portion of the first anchor body 230A at the interior side of the device (400 to 900). At least one flange 252B extends from the second base portion of the second anchor body 230B at the interior side of the device (400 to 900). The flanges (252A, 252B) extending from the respective base portion of the anchor bodies (230A, 230B) lies adjacent to an interior side of the first and second expander body (202, 204). The inner flanges (252A, 252B) from the anchor body (230A, 230B) are designed to provide 3D stability to the skeletal expander during midfacial expansion treatment and handle the forces from 3D midfacial expansion.

[0150] Referring to FIG. 43 to FIG. 50, the present invention discloses a midfacial expander device (1000, 1100). The device (1000, 1100) comprises at least ten TADs (346, 338A - 338F). The device (1000, 1100) comprises a first expander body 302 anda second expander body 304. The first expander body 302 comprises a first sleeve 306A and a first alignment rod 308A. The second expander body 304 comprises a second alignment rod 308B and a second sleeve 306B. The first sleeve 306A is arranged to receive the second alignment rod 3O8B and the second sleeve 306B is arranged to receive the first alignment rod 3O8A.

[0151] In one embodiment, the sleeves (306A, 306B) of the device (1000, 1100) have a square-shaped cross-section and alignment rods (3O8A, 3O8B) of the device (1000, 1100) have a circular- shaped cross-section. The sleeves (306A, 306B) and alignment rods (3O8A, 3O8B) may have any shape. In another embodiment, sleeves (306A, 306B) and alignment rods (3O8A, 3O8B) may have a pentagon shape or a hexagon shape. The first expander body 302 comprises a first base and the second expander body 304 comprises a second base. The sleeves (306A, 306B) and alignment rods (308A, 3O8B) extend from the respective first base and second base of the respective first expander body 302 and the second expander body 304.

[0152] The first expander body 302 comprises a first threaded hole 310 and the second expander body 304 comprises a second threaded hole 312. The first threaded hole 310 is formed such that an axis of the first threaded hole 310 is parallel to an axis of the first alignment rod 308 A. The second threaded hole 312 is formed such that an axis of the second threaded hole 312 is parallel to an axis of the second alignment rod 308B. The first threaded hole 310 and the second threaded hole 312 lie on a same axis.

[0153] The device (1000, 1100) further comprises an expansion screw assembly 314. The expansion screw assembly 314 comprises an intermediate activation member 316. The intermediate activation member 316 further comprises at least one taper portion (318, 320) extending from each side of the intermediate activation member 316. A first threaded portion 322 extends from the taper portion 318 at a first side of the intermediateactivation member 316 and a second threaded portion 324 extends from the taper portion 320 at a second side of the intermediate activation member 316. The first side is opposite to the second side of the intermediate activation member 316. The first threaded portion 322 is received within the first threaded hole 310 and the second threaded portion 324 is received within the second threaded hole 312. The expansion screw assembly 314 is activated using an activation wrench. The intermediate activation member 316 has a hexagon shape. In another embodiment, the intermediate activation member 316 may have any other shapes, which fall under the scope of this invention.

[0154] The device (1000, 1100) further comprises a first anchor body 326 and a second anchor body 328. The first expander body 302 is mounted over the first anchor body 326 and the second expander body 304 is mounted over the second anchor body 328. One or more assembly screws (33OA, 33OB, 330C, 330D) fasten the first expander body 302 over the first anchor body 326 and the second expander body 304 over the second anchor body 328.

[0155] The first expander body 302 comprises one or more first assembly holes (332A, 332B) and the first anchor body 326 comprises one or more second assembly holes (332C, 332D). One or more assembly screws (33OA, 330B) fasten the first expander body 302 to the first anchor body 326 via one or more first assembly holes (332A, 332B) and one or more second assembly holes (332C, 332D). The second expander body 304 comprises one or more first assembly holes (336A, 336B) and the second anchor body 328 comprises one or more second assembly holes (336C, 336D). One or more assembly screws (330C, 330D) fasten the second expander body 304 to the second anchor body 328 via one or more first assembly holes (336A, 336B) and one or more second assembly holes (336C, 336D).

[0156] In another embodiment, the expander body (302, 308) is mounted to the anchor body (326, 328) by any other conventional fastening means. In one embodiment, the alignment rods (308A, 3O8B) are configured to telescope through the sleeves (306A, 306B). In one embodiment, the alignment rods (308A, 3O8B) are press fit to the respective expander body (302, 308). In another embodiment, the alignment rods (3O8A, 308B) integrally extend from the respective expander body (302, 304). Further, one or more anchor screws (338A, 338B, 338C, 338D, 338E, 338F) extend from the first anchor body 326 and the second anchor body 328 to attach the device (1000, 1100) to the maxilla of a patient. The anchor screws (338A, 338B, 338C, 338D, 338E, 338F) are also a TAD. Optionally the device (1000, 1100) may or may not include molar attachments to the teeth or attachments to the side palate.

[0157] Each anchor body (326, 328) comprises a base portion (370, 374) and a support portion (372, 376). The first anchor body 326 comprises a first base portion 370 and the second expander body 308 comprises a second base portion 374. The first anchor body 326 comprises a first support portion 372 and the second anchor body 328 comprises a second support portion 376.

[0158] Each base portion (370, 374) comprises a first side or a front side, a second side or a rear side opposite to the first side, a third side or the outer side and a fourth side or an interior side opposite to the third side. Each support portion (372, 376) and the base portion (370, 374) defines a first cavity and a second cavity to receive the first base and second base of the first anchor body 326 and the second anchor body 328, respectively. Each support portion (372, 376) comprises a front support portion, a side support portion and a rear support portion. The front support portion extends from the first side of the respective base portion (370, 374) and the side support portion extends from the third side of the respective base portion (370, 374). The side support portion comprises one or more spaces to allow passage of alignment rods (308A, 308B) and sleeves (306A,306B). The rear support portion extends from the second side of the respective base portion (370, 374).

[0159] The front support portion of the first anchor body 326extends to conform to a front portion and a corner portion of the first expander body 302. The rear support portion of the first anchor body 326extends to conform to a rear portion of the first expander body 302.

[0160] The front support portion of the second anchor body extends to conform a front portion of the second expander body 304. The rear support portion of the second anchor body 328extends to conform a rear portion and a rear corner portion of the second expander body 304. Each front support portion and rear support portion comprises a threaded hole (378, 382, 392, 394). The threaded hole (378, 382) receives respective anchorage screws or temporary anchorage devices 346.

[0161] The device (1000, 1100) comprises at least two first blocks (350A, 350B). At least one first block 350 A extends perpendicularly from a midportion of the first sleeve 306A and at least one first block 350B extends perpendicularly from a midportion of the second sleeve 306B.

[0162] The device (1000, 1100) further comprises at least two second blocks (390, 396). At least one second block 390 extends from the fourth side of the first anchor body 326 and at least one second block 392 extends from the fourth side of the second anchor body 328. Referring to FIG. 47 to FIG. 50, each side support portion comprises a threaded hole 388. The threaded hole 388 receives respective anchorage screws or temporary anchorage devices 346.

[0163] While the disclosure has been described with reference to exemplary embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the disclosure. In addition, many modifications may be made to adapt a particular system, device or component thereof to the teachings of the disclosure without departing from the essential scope thereof. Therefore, it is intended that the disclosure not be limited to the particular embodiments disclosed for carrying out this disclosure, but that the disclosure will include all embodiments falling within the scope of the appended claims. Moreover, the use of the terms first, second, etc. do not denote any order or importance, but rather the terms first, second, etc. are used to distinguish one element from another.

[0164] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and / or “comprising,” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0165] The description of the present disclosure has been presented for purposes of illustration and description, but is not intended to be exhaustive or limited to the disclosure in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope of the disclosure. The described embodiments were chosen and described in order to best explain the principles of the disclosure and the practical application, and to enable others of ordinary skill inthe art to understand the disclosure for various embodiments with various modifications as are suited to the particular use contemplated.

Claims

CLAIMSWhat is claimed is:

1. A midfacial expander device, comprising: a first expander body comprises a first base having a first side and a second side opposite to the first side, a first sleeve extends from the first side of the first base and a first alignment rod extends from the second side of the first base, wherein the first sleeve is parallel to the first alignment rod, and wherein the first base comprises a first threaded hole; a second expander body disposed parallel to the first expander body comprises a second base having a first side and a second side opposite to the first side, a second sleeve extends from the second side of the second base and a second alignment rod extends from the first side of the second base, wherein the first sleeve is configured to receive the second alignment rod and the second sleeve is configured to receive the first alignment rod, and wherein the second base comprises a second threaded hole coaxial to the first threaded hole of the first base and parallel to an axis of the alignment rods; an adjustable expansion screw assembly extends between the first expander body and the second expander body; a first anchor body configured to support the first expander body, wherein the first anchor body comprises a first base portion and a first support portion extends from at least a portion of a periphery the first base portion and defines a firstcavity, wherein the first cavity is configured to support the first base of the first expander body, and a second anchor body configured to support the second expander body, wherein the first anchor body and the second anchor body are configured to fix the device to a maxilla of the patient via one or more anchor screws, wherein the second anchor body comprises a second base portion and a second support portion extends from at least a portion of a periphery the second base portion and defines a second cavity, wherein the second cavity is configured to support the second base of the second expander body.

2. The device of claim 1, wherein each base portion comprises a first side, a second side opposite to the first side, a third side, a fourth side opposite to the third side, wherein each support portion comprises a front support portion and a side support portion, wherein the front support portion extends from the first side of the first base portion and the side support portion extends from the third side of the first base portion, wherein the side support portion comprises one or more gaps to allow passage of alignment rods and sleeves.

3. The device of claim 2, wherein the front support portion is configured to support at least one temporary anchorage assembly, and the rear support portion is configured to support at least one temporary anchorage assembly, wherein each temporary anchorage assembly comprises a hollow locking member and a temporary anchorage screw, wherein the hollow locking member comprises a cylindrical portion comprising a plurality of first threads at an interior side of the hollow locking member, and wherein the temporary anchorage screw comprises a head portion having a plurality of second threads at an exterior side, wherein the temporary anchorage screw is configured to lock with the hollow lockingmember as the second threads of the temporary anchorage screw screws over the first threads of the hollow locking member.

4. The device of claim 2, wherein at least one of the front support portion and the rear support portion is configured to support at least one temporary anchorage assembly, wherein each temporary anchorage assembly comprises a hollow locking member and a temporary anchorage screw, wherein the hollow locking member comprises a cylindrical portion comprising a plurality of first threads at an interior side of the hollow locking member, and wherein the temporary anchorage screw comprises a head portion having a plurality of second threads at an exterior side, wherein the temporary anchorage screw is configured to lock with the hollow locking member as the second threads of the temporary anchorage screw screws over the first threads of the hollow locking member.

5. The device of claim 4, further comprises a first support member attached to an exterior side of the first anchor body, wherein the exterior side defines an outer surface of the first anchor body opposite to a side of the first sleeve and the first alignment rod, wherein the first support member is configured to angularly support at least two temporary anchorage assemblies, and a second support member attached to an exterior side of the second anchor body, wherein the second support member is configured to angularly support at least two temporary anchorage assemblies, wherein the exterior side of the second anchor body defines an outer surface of the second anchor body opposite to a side of the second sleeve and the second alignment rod, wherein each temporary anchorage assembly comprises a hollow locking member and a temporary anchorage screw, wherein the hollow locking membercomprises a cylindrical portion comprising a plurality of first threads at an interior side of the hollow locking member, and wherein the temporary anchorage screw comprises a head portion having a plurality of second threads at an exterior side, wherein the temporary anchorage screw is configured to lock with the hollow locking member as the second threads of the temporary anchorage screw screws over the first threads of the hollow locking member.

6. The device of claim 5, further comprises one or more flange members extending from the exterior side of the first anchor body and the second anchor body, wherein the first support member comprises one or more holes arranged complementary to the arrangement of flange members to receive the flange members of the first anchor body therein for affixing the first support member to the first anchor body, and wherein the second support member comprises one or more holes arranged complementary to the arrangement of flange members to receive the flange members of the second anchor body therein for affixing the second support member to the second anchor body.

7. The device of claim 2, wherein each support portion comprises a rear support portion extending from the second side of the first base portion and the second base portion, respectively.

8. The device of claim 2, wherein at least one of the front support portion and the rear support portion comprises one or more holes to receive one or more protraction wires.

9. The device of claim 2, wherein the front support portion is configured to support at least one temporary anchorage assembly and wherein the rear support portion comprises one or more holes to receive one or more protraction wires, wherein each temporary anchorage assembly comprises a hollow locking member and a temporary anchorage screw, wherein the hollow locking member comprises a cylindrical portion comprising a plurality of first threads at an interior side of the hollow locking member, and wherein the temporary anchorage screw comprises a head portion having a plurality of second threads at an exterior side, wherein the temporary anchorage screw is configured to lock with the hollow locking member as the second threads of the temporary anchorage screw screws over the first threads of the hollow locking member.

10. The device of claim 2, wherein the front support portion is configured to support at least one temporary anchorage assembly and wherein the rear support portion is configured to support at least one temporary anchorage assembly, wherein a top surface of the front support portion has additional space compared to a top surface of the rear support portion, wherein each temporary anchorage assembly comprises a hollow locking member and a temporary anchorage screw, wherein the hollow locking member comprises a cylindrical portion comprising a plurality of first threads at an interior side of the hollow locking member, and wherein the temporary anchorage screw comprises a head portion having a plurality of second threads at an exterior side, wherein the temporary anchorage screw is configured to lock with the hollow locking member as the second threads of the temporary anchorage screw screws over the first threads of the hollow locking member11. The device of claim 2, wherein the side support portion is configured to support at least one temporary anchorage assembly, wherein each temporary anchorageassembly comprises a hollow locking member and a temporary anchorage screw, wherein the hollow locking member comprises a cylindrical portion comprising a plurality of first threads at an interior side of the hollow locking member, and wherein the temporary anchorage screw comprises a head portion having a plurality of second threads at an exterior side, wherein the temporary anchorage screw is configured to lock with the hollow locking member as the second threads of the temporary anchorage screw screws over the first threads of the hollow locking member12. The device of claim 1, wherein the expansion screw assembly comprises an intermediate activation member, a first threaded portion, and a second threaded portion, wherein the intermediate activation member having a first side and a second side opposite to the first side, wherein the first threaded portion extends from the first side of the intermediate activation member to the first threaded hole of the first expander body and the second threaded portion extends from the second side of the intermediate activation member to the second threaded hole of the second expander body.

13. The device of claim 1, wherein the expansion screw assembly including an intermediate activation member, a first rod member extending from one end of the intermediate activation member, and a second rod member extending from the opposite end of the intermediate activation member, wherein said first and second rod members are configured to telescope within the intermediate activation member14. The device of claim 13, wherein the intermediate activation member designed as an elongated hollow member, wherein the intermediate activation member having an interior hollow portion comprising inner threads extending along atleast a portion of its length, wherein the interior hollow portion including a first hollow portion and a second hollow portion integrally extending from the first hollow portion, featuring different inner diameters, wherein the first rod member with a first threaded portion featuring multiple threads formed on an exterior side, wherein the second rod member comprising a first portion designed to fit within the hollow portion, incorporating a third hollow portion and a second threaded portion with multiple threads along a portion of its length, wherein the first portion of the second rod member complements the second hollow portion of the intermediate activation member, wherein the first rod member passes through the first hollow portion and into the third hollow portion of the second rod member within the intermediate activation member, and activation of the intermediate activation member causes the first and second threads of the rod members to reversely thread over the inner threads of the first and second hollow portions, facilitating telescopic retraction.

15. The device of claim 1, wherein the first expander body comprises one or more first threaded assembly holes and the first anchor body comprises one or more second threaded assembly holes, wherein the first threaded assembly holes are arranged complementary to the arrangement of the second threaded assembly holes, wherein the first threaded assembly holes of the first expander body and the second threaded assembly holes of the first anchor body are fastened via one or more assembly screws.

16. The device of claim 1, wherein the second expander body comprises one or more third threaded assembly holes and the second anchor body comprises one or morefourth threaded assembly holes, wherein the third threaded assembly holes are arranged complementary to the arrangement of the fourth threaded assembly holes, wherein the third threaded assembly holes of the second expander body and the fourth threaded assembly holes of the second anchor body are fastened via one or more assembly screws.

17. The device of claim 1, wherein the first anchor body comprises one or more first threaded anchor holes and the second anchor body comprises one or more second threaded anchor holes, wherein the first threaded anchor holes and the second threaded anchor holes are configured to receive one or more anchor screws to fix the device to the maxilla of the patient.

18. The device of claim 1, further comprises at least two first blocks, wherein at least one first block extends perpendicularly from a midportion of the first sleeve and at least one first block extends perpendicularly from a midportion of the second sleeve, wherein the first blocks extend in a direction of anchor screws.

19. The device of claim 1, further comprises at least two second blocks, wherein at least one second block extends perpendicularly from the fourth side of the base portion of the first anchor body and at least one second block extends perpendicularly from the fourth side of the base portion of the second anchor body, wherein the second blocks extend in a direction opposite to anchor screws.

20. The device of claim 1, wherein the first and the second side of the intermediate activation member comprises at least one tapered portion.

21. The device of claim 1 , wherein the intermediate activation member has a hexagon shape.

2. The device of claim 1, wherein the first alignment rod and the second alignment rod are press fit connected to the first expander body and the second expander body, respectively.

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