Midfacial expander device

Abstract

The present invention discloses a midfacial expander device with temporary anchorage devices (TADs) and locked alignment rods. 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 first expander body and the second expander body, respectively. The device comprises assembly screws to fasten the expander body to the anchor body. The device further comprises anchor screws and temporary anchorage devices (TADs) for application of device to the maxilla of the patient. The TADs are fixed at the respective anchor body and extend outwards with respect to the device.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS The present application claims the benefit of US provisional application US 63 / 448,013 filed on 24-FEB-2023 entitled “MAXILLARY EXPANDER DEVICE WITH INTEGRAL ALIGNMENT RODS AND ENHANCED EXPANSION SCREW ASSEMBLY”, which further claims benefit of US provisional application US 63 / 459,796 filed on 17-APR-2023, which further benefit of US provisional application US 63 / 529,404 filed on 28-JUL-2023 entitled “PATIENT-SPECIFIC MIDFACIAL EXPANDER DEVICE”, which further claim benefit of US provisional application US 63 / 534,175 filed on 23-AUG-2023 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. BACKGROUND

[0002] Maxillary expansion treatments are known in the art for correction of a maxillary transverse discrepancy. Correction of transverse discrepancies usually requires expansion of the palate by a combination of orthopedic and orthodontic tooth movements. The expansion treatment modality used may be (i) rapid maxillary expansion (RME), (ii) slow maxillary expansion (SME), or (iii) surgically assisted maxillary expansion. The main object of RME is to correct maxillary arch narrowness. During treatment, transverse forces are applied to induce bone separation at a maxillary 1 suture. Maxillary expansion can be used to correct crossbite, and to aid maxillary protraction and mild crowding.

[0003] FIG. 1 shows a conventional maxillary skeletal expander 10 emplaced against the palate, or with implants, into the maxilla of a patient. The maxillary expander 10 includes expansion body housing units (12, 14) and alignment rods (16, 18). The maxillary expander 10 utilizes a hygienic rapid expansion (Hydrax) screw 22, which is a non-spring-loaded jackscrew with wire frame.

[0004] The conventional hyrax-style expansion screw 22 glides along a pair of guide rails, or alignment rods (16, 18) in order to maintain alignment of the expansion screw 22 when facing great resistance during skeletal maxillary expansion. However, since the alignment rods (16, 18) are otherwise unconstrained within the expansion body housing 12, the alignment rods (16, 18) are as a consequence susceptible to misalignment and dislodgement.

[0005] In another example, shown in FIG. 2A and FIG. 2B, a conventional hyrax-style maxillary skeletal expander 30 includes centrally mounted support bars (32, 34). The centrally mounted support bars (32, 34) are designed to constrain the motion of alignment rods (36, 38). However, these centrally mounted bars (32, 34) are prone to bending and / or deformation, which can interfere with the expansion activation of the maximal skeletal expander 30.

[0006] There is shown in FIG. 3, another prior art embodiment of a hyrax- style maxillary expander. The maxillary expander 40 was developed in an attempt to solve the misalignment problems plaguing conventional maxillary skeletal expanders. The maxillary expander 40 uses rigid supports (46,48) between alignment rods (42, 44). The rigid supports (46, 48) are disposed centrally and perpendicular to the expansion screw 49, to eliminate motion in the alignment rods (42, 44) while still providing for the alignment function of the maxillary expander 40. However, the maxillary expander 40 lacks to provide a robust design.

[0007] In yet another example, a conventional maxillary expander device 50 is shown in FIG. 4. In yet another example, a conventional maxillary expander device 60 is shown in FIG. 5. The maxillary expander device (50, 60) implanted to a maxilla of a patient. The maxillary expander device (50, 60) comprises a first expander body (52, 62), a second expander body (54, 64) and an expansion screw assembly (56, 66) disposed between the first expander body (52, 62) and the second expander body (54, 64). The expansion screw assembly (56, 66) is configured to expand the expander body (52, 62, 54, 64) to expand the maxilla of the patient. However, the expander body (52, 62, 54, 64) becomes misaligned while activating the expansion screw assembly (56, 66), as shown in FIG. 4 and 5. The maxillary expander device (50, 60) lacks to provide a robust design.

[0008] In yet another example, a prior art miniscrew-assisted rapid palatal expander device 70 with bone anchorage is shown in FIG. 6. The device 70 is also susceptible to misalignment. Therefore, the miniscrew-assisted rapid palatal expander device 70 also lacks to provide stability to the device 70 and robust design.

[0009] Therefore, there is a need for a maxillary expander device that has a more robust structure and provides better mechanical performance during and after the application of the device to both patient and clinician.

[0010] Another problem is 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, craniofacial deformities, 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.

[0011] 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.

[0012] 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.

[0013] Therefore, there is a need for a solution that effectively addresses midface deficiencies with a less invasive procedure. SUMMARY

[0014] The present invention discloses a maxillary expander device having integral alignment rods and enhanced expansion screw assembly. The maxillary expander device is a telescopic maxillary expander device. The device comprises a first expander body and a second expander body. The first expander body comprises a first sleeve and a first alignment rod. The second expander body comprises a second alignment rod and a second sleeve. The first sleeve is arranged to receive the second alignment rod and the second sleeve is arranged to receive the first alignment rod. In one embodiment, the alignment rod (104A, 104B) integral to the respective expander body (102, 108) is a unibody alignment rod (104A, 104B). In one embodiment, the unibody alignment rod (104A, 104B) could be achieved via at least one of additive manufacturing, subtractive manufacturing, threaded rod, flanged rod, welded rod, etc.

[0015] The first expander body comprises a first threaded hole and the second expander body comprises a second threaded hole. The first threaded hole is formed such that an axis of the first threaded hole is parallel to an axis of the first alignment rod. The second threaded hole is formed such that an axis of the second threaded hole is parallel to an axis of the second alignment rod. The first threaded hole and the second threaded hole lie on a same axis.

[0016] In another embodiment, the device comprises at least one sleeve, or the first sleeve, and at least one alignment rod, or a second alignment rod. The device further comprises an expansion screw assembly. The expansion screw assembly comprises an intermediate activation member, a first threaded portion extending from a first side of the intermediate activation member and a second threaded portion extending from a second side of the intermediate activation member. The first side is opposite to the second side of the intermediate activation member. The first threaded portion is received within the first threaded hole and the second threaded portion is received within the second threaded hole.

[0017] In one embodiment, the intermediate activation member comprises at least two taper portions extending from each side of the intermediate activation member, and the first and second threaded portion extends from the taper portions from each side of the intermediate activation member. In another embodiment, the intermediate activation member comprises at least one taper portion extending from each side of the intermediate activation member, and the first and second threaded portion extends from the taper portions from each side of the intermediate activation member.

[0018] The device further comprises a first anchor body and a second anchor body. The first expander body is mounted over the first anchor body and the second expander body is mounted over the second anchor body. One or more assembly screw fastens the first expander body over the first anchor body and the second expander body over the second anchor body. In another embodiment, the device further comprises one or more anchor screws extending from the first and second anchor body to fix the device to the maxilla of the patient. In one embodiment, the expansion screw assembly is an adjustable expander. The expansion screw assembly comprises any expansion mechanism that pushes the anchor body from one another.

[0019] In another embodiment, the present invention further discloses a maxillary expander device having an enhanced expansion screw assembly and a protraction wire support assembly. The maxillary expander device is a telescopic maxillary expander device. The device comprises a first expander body and a second expander body. The first expander body comprises a first sleeve and a first alignment rod. The second expander body comprises a second alignment rod and a second sleeve. The first sleeve is arranged to receive the second alignment rod and the second sleeve is arranged to receive the first alignment rod.

[0020] The first expander body comprises a first threaded hole and the second expander body comprises a second threaded hole. The first threaded hole is formed such that an axis of the first threaded hole is parallel to an axis of the first alignment rod. The second threaded hole is formed such that an axis of the second threaded hole is parallel to an axis of the second alignment rod. The first threaded hole and the second threaded hole lie on a same axis.

[0021] The device further comprises an expansion screw assembly. The expansion screw assembly comprises an intermediate activation member, a first rod member and a second rod member. The first rod member extends from a first end portion of the intermediate activation member and the second rod member extends from a second end portion of the intermediate activation member. The first end portion is opposite to the second end portion of the intermediate activation member. The first rod member and the second rod member are configured to telescopically move within the intermediate activation member.

[0022] The device further comprises a first anchor body and a second anchor body. The first expander body is mounted over the first anchor body and the second expander body is mounted over the second anchor body. One or more assembly screw fastens the first expander body over the first anchor body and the second expander body over the second anchor body. In another embodiment, the device further comprises one or more anchor screws extending from the first and second anchor body to fix the device to the maxilla of the patient. In one embodiment, the expansion screw assembly is an adjustable expander. The expansion screw assembly comprises any expansion mechanism that pushes the anchor body from one another.

[0023] The device further comprises a protraction wire support assembly including a first wire support assembly and a second wire support assembly. The protraction wire support assembly is formed between the expansion screw assembly, and the first sleeve and the first alignment rod. The protraction wire support assembly is configured to support and fasten one or more protraction wires to apply forward traction, protraction and midfacial advancement forces.

[0024] In yet another embodiment, the present invention discloses a patient-specific midfacial expander device with temporary anchorage devices (TADs) and locked alignment rods. The 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.

[0025] The 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. Further, 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.

[0026] In one embodiment, the first sleeve and second sleeve have an interior hollow portion having a cross-section complementary to the first alignment rod and the second alignment rod, respectively. In one embodiment, the first alignment rod and the second alignment rod have a circular shaped cross-section and the interior portion of the first sleeve and the second sleeve have a circular shaped cross-section.

[0027] The first sleeve and the second sleeve have at least one of a square shaped crosssection, a circular shaped cross-section, a hexagon shaped cross-section and a pentagon shaped cross-section at an exterior side of the first and second sleeves. In one embodiment, the first alignment rod and the second alignment rod are press fit to the first expander body and the second expander body, respectively.

[0028] The device further comprises an expansion screw assembly extend between the first expander body and the second expander body. 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. In one embodiment, the first and the second side of the intermediate activation member comprise at least one tapered portion. In one embodiment, the intermediate activation member has a hexagon shape. In one embodiment, the device comprises at least one alignment rod locked, and at least one expansion screw. Also, it should be emphasized that the alignment rod is configured to be a rigid uniconstruct with the expander body. It can be done through many manufacturing methods including additive manufacturing, but the concept of being unibody with the expander is the main feature.

[0029] The device further comprises a first anchor body configured to support the first expander body. The 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. In one embodiment, the expansion screw assembly is an adjustable expander. The expansion screw assembly comprises any expansion mechanism that pushes the anchor body from one another.

[0030] 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.

[0031] 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.

[0032] The first support member and the second support member are customizable for placement of the temporary anchorage assemblies at a desired position of the maxilla of the patient. The intermediate activation member on rotation causes bidirectional outward movement of the first and second expander body and temporary anchorage assemblies, and exerts outward, lateral force on the patient's palate.

[0033] Further, 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. 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.

[0034] The device further comprises a tube member comprising a plurality of third threads at an exterior surface of tube member. The third threads of the tube member thread over at least a portion of the first threads of the hollow locking member, thereby locking the tube member with the respective hollow locking member. The tube member is configured to guide a pilot drill.

[0035] The first anchor body 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.

[0036] The device further comprises at least two blocks. At least one block extends perpendicularly from a midportion of the first sleeve and at least one block extends perpendicularly from a midportion of the second sleeve. Each block has a wedge shape at a free end. 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.

[0037] Further, 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.

[0038] 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.

[0039] 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. Various configuration and embodiments where these inventions can be applied and configured. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] 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 leachings of the present disclosure are shown and described with respect to the figures presented herein, in which:

[0041] FIG. 1 is a prior art maxillary expander device.

[0042] FIG. 2A and FIG. 2B is another prior art maxillary expander device.

[0043] FIG. 3 is yet another prior art maxillary expander device.

[0044] FIG. 4 is yet another prior art maxillary expander device.

[0045] FIG. 5 is yet another prior art maxillary expander device expanding the maxilla of the patient.

[0046] FIG. 6 is a prior art miniscrew-assisted rapid palatal expander device.

[0047] FIG. 7 exemplarily illustrates a perspective view of a maxillary expander device fixed to a maxilla of the patient, according to an embodiment of the present invention.

[0048] FIG. 8 exemplarily illustrates a perspective view of a maxillary expander device, according to an embodiment of the present invention.

[0049] FIG. 9 exemplarily illustrates a perspective view of a maxillary expander device of FIG. 7 in an expanded position.

[0050] FIG. 10 exemplarily illustrates a top view of the alignment rods assembled to the sleeves of the maxillary expander device of FIG. 7.

[0051] FIG. 11 exemplarily illustrates a side view of an expansion screw assembly of the maxillary expander device of FIG. 7.

[0052] FIG. 12 exemplarily illustrates a cross-sectional view of the expansion screw assembly assembled to the maxillary expander device of FIG. 7.

[0053] FIG. 13 exemplarily illustrates a cross-sectional view of an expander body assembled over an anchor body, according to an embodiment of the present invention.

[0054] FIG. 14 exemplarily illustrates a perspective view of a maxillary expander device, according to another embodiment of the present invention.

[0055] FIG. 15 exemplarily illustrates an exploded view of the maxillary expander device of FIG. 14.

[0056] FIG. 16 exemplarily illustrates a perspective view of a maxillary expander device, according to yet another embodiment of the present invention.

[0057] FIG. 17 exemplarily illustrates a side view of an expansion screw assembly, according to another embodiment of the present invention.

[0058] FIG. 18 exemplarily illustrates a perspective view of a maxillary expander device fixed to a maxilla of the patient, according to yet another embodiment of the present invention.

[0059] FIG. 19 exemplarily illustrates a perspective view of the maxillary expander device of FIG. 18.

[0060] FIG. 20 exemplarily illustrates another perspective view of the maxillary expander device of FIG. 18.

[0061] FIG. 21 exemplarily illustrates a perspective view of a maxillary expander device, according to yet another embodiment of the present invention.

[0062] FIG. 22 exemplarily illustrates an exploded view of the maxillary expander device of FIG. 21.

[0063] FIG. 23 exemplarily illustrates an exploded view of an expansion screw assembly, according to yet another embodiment of the present invention.

[0064] FIG. 24 exemplarily illustrates a perspective view of a maxillary expander device, according to yet another embodiment of the present invention.

[0065] FIG. 25 exemplarily illustrates a perspective view of the maxillary expander device of FIG. 24 in an expanded position.

[0066] FIG. 26 exemplarily illustrates an exploded view of an expander body and anchor body of the maxillary expander device of FIG. 24.

[0067] FIG. 27 exemplarily illustrates a side view of the maxillary expander device of FIG. 24.

[0068] FIG. 28 exemplarily illustrates a bottom perspective view of a first and second expander body of the maxillary expander device of FIG. 24.

[0069] FIG. 29 exemplarily illustrates a bottom perspective view of the first expander body of the maxillary expander device of FIG. 24.

[0070] FIG. 30 exemplarily illustrates a perspective view of an expansion screw assembly of FIG. 24.

[0071] FIG. 31 exemplarily illustrates an exploded view of the expansion screw assembly of FIG. 30.

[0072] FIG. 32 exemplarily illustrates a cross-section of the expansion screw assembly od FIG. 31.

[0073] FIG. 33 exemplarily illustrates a cross-section of the expansion screw assembly of FIG. 31 in expanded position.

[0074] FIG. 34 exemplarily illustrates a perspective view of a patient-specific midfacial skeletal expander device, according to an embodiment of the present invention. FIG. 35 exemplarily illustrates a perspective view of the patient-specific midfacial skeletal expander device of FIG. 34 in an expanded position.

[0075] FIG. 36 exemplarily illustrates an exploded view of the patient-specific midfacial skeletal expander device of FIG. 34.

[0076] FIG. 37 exemplarily illustrates a side view of the patient-specific midfacial skeletal expander device of FIG. 34.

[0077] FIG. 38 exemplarily illustrates a perspective view of a hollow locking member, according to an embodiment of the present invention.

[0078] FIG. 39 exemplarily illustrates a perspective view of a support member supporting temporary anchorage devices, according to an embodiment of the present invention.

[0079] FIG. 40 exemplarily illustrates an exploded view of a support member and temporary anchorage devices, according to an embodiment of the present invention.

[0080] FIG. 41 exemplarily illustrates a predrill abutment tube member locked with the hollow locking member to guide a pilot drill, according to an embodiment of the present invention.

[0081] FIG. 42 exemplarily illustrates a perspective view of the predrill abutment tube member of FIG. 41.

[0082] FIG. 43 exemplarily illustrates a perspective view of a patient-specific midfacial skeletal expander device, according to another embodiment of the present invention.

[0083] FIG. 44 exemplarily illustrates an exploded view of the patient-specific midfacial skeletal expander device of FIG. 41.

[0084] FIG. 45 exemplarily illustrates a perspective view of an expander body of FIG. 41.

[0085] FIG. 46 exemplarily illustrates a side view of the patient-specific midfacial skeletal expander device of FIG. 41.

[0086] FIG. 47 exemplarily illustrates a bottom view of the patient-specific midfacial skeletal expander device of FIG. 41.

[0087] FIG. 48 exemplarily illustrates a bottom perspective view of the patient-specific midfacial skeletal expander device of FIG. 41 in an expanded position.

[0088] FIG. 49 exemplarily illustrates a bottom perspective view of the patient-specific midfacial skeletal expander device of FIG. 41. DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

[0089] 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 in other 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.

[0090] Referring to FIG. 7, FIG. 8, FIG. 9 and FIG. 10, a maxillary expander device 100 comprises a first expander body 102 and a second expander body 108. The first expander body 102 comprises a first sleeve 110A and a first alignment rod 104A. The second expander body 108 comprises a second alignment rod 104B and a second sleeve HOB. The first sleeve 110A is arranged to receive the second alignment rod 104B and the second sleeve HOB is arranged to receive the first alignment rod 104A. In one embodiment, the sleeves (110A, HOB) of the device 100 have a square-shaped crosssection and alignment rods (104 A, 104B) of the device 100 have a circular-shaped crosssection. The sleeves (110A, 110B) and alignment rods (104A, 104B) may have any shape. In another embodiment, sleeves (110A, HOB) and alignment rods (104A, 104B) may have a pentagon shape or a hexagon shape. The alignment rod (104A, 104B) integral to the respective expander body (102, 108) is a unibody alignment rod (104A, 104B). In one embodiment, the unibody alignment rod (104A, 104B) could be achieved via at least one of additive manufacturing, subtractive manufacturing, threaded rod, flanged rod, welded rod, etc. [0091 ] Referring to FIG. 9, The first expander body 102 comprises a first threaded hole 106 and the second expander body 108 comprises a second threaded hole 112. The first threaded hole 106 is formed such that an axis of the first threaded hole 106 is parallel to an axis of the first alignment rod 104A. 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 104B. The first threaded hole 106 and the second threaded hole 112 lie on a same axis.

[0092] Referring to FIG. 8 to FIG. 12, the device 100 further comprises an expansion screw assembly 120. The expansion screw assembly 120 comprises an intermediate activation member 156. The intermediate activation member 156 further comprises at least two taper portions (158, 160) extending from each side of the activation member 156. A first threaded portion 122 extends from the taper portion 160 at a first side of the intermediate activation member 156 and a second threaded portion 124 extends from the taper portion 160 at a second side of the intermediate activation member 156. The first side is opposite to the second side of the intermediate activation member 156. The first threaded portion 122 is received within the first threaded hole 106 and the second threaded portion 124 is received within the second threaded hole 112. The expansion screw assembly 120 is activated using an activation wrench.

[0093] Referring to FIG. 8, FIG. 9, and FIG. 13, the device 100 further comprises a first anchor body 132 and a second anchor body 134. The first expander body 102 is mounted over the first anchor body 132 and the second expander body 108 is mounted 19 over the second anchor body 134. One or more assembly screw (116A, 116B, 116C, 116D) fastens the first expander body 102 over the first anchor body 132 and the second expander body 108 over the second anchor body 134. In one embodiment, the expansion screw assembly 120 is an adjustable expander. The expansion screw assembly 120 comprises any expansion mechanism that pushes the anchor body (132, 134) from one another. The adjustable expander could include at least one of different style of expanders, expansion screw styles, and expansion mechanisms.

[0094] The first expander body 102 comprises one or more first assembly holes (114A, 114B) and the first anchor body 132 comprises one or more second assembly holes (126A, 126B). One or more assembly screws (116A, 116B) fasten the first expander body 102 to the first anchor body 132 via one or more first assembly holes (114A, 114B) and one or more second assembly holes (126A, 126B). The second expander body 108 comprises one or more first assembly holes (114C, 114D) and the first anchor body 132 comprises one or more second assembly holes (126C, 126D). One or more assembly screws (116C, 116D) fasten the second expander body 108 to the second anchor body 134 via one or more first assembly holes (114C, 114D) and one or more second assembly holes (126C, 126D). The assembly holes (114A, 114B, 114C, 114D) shown in FIG. 15 and the assembly hole (126A, 126B, 126C, 126D) shown in FIG. 22 are applicable for the embodiments (100, 200, 400, 500) of FIG. 8, FIG. 14, FIG. 19 and FIG. 21. Hence, the FIG. 15 and FIG. 22 shall be referred.

[0095] In another embodiment, the expander body (102,108) is mounted to the anchor body (132, 134) by any other conventional fastening means. In one embodiment, the alignment rods (104A, 104B) are configured to telescope through the sleeves (110A, HOB). In one embodiment, the alignment rods (104A, 104B) are press fit to the respective expander body (102, 108). Further, one or more anchor screws (118A, 118B, 118C, 118D, 118E, 118F) extend from the first anchor body 132 and the second anchor body 134 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.

[0096] FIG. 14 and FIG. 15 exemplarily illustrate a maxillary expander device 200, according to another embodiment of the present invention. Embodiments 200 have the same components and function as the embodiment 100 with variation in the design of the alignment rods (104A, 104B) and sleeves (110A, HOB). Hence, to avoid repetition, only the alignment rods (104A, 104B) and sleeves (110A, 110B) are explained in FIG. 14 and FIG. 15. The arrangement of other components of device 200 can be understood with reference to the explanation of embodiment 100. The alignment rods (104 A, 104B) of device 200 have a square-shaped cross-section. Further, sleeves (110A, HOB) of device 200 have a square-shaped cross-section. The alignment rod (104A, 104B) is a unibody alignment rod (104A, 104B). In one embodiment, the unibody alignment rod (104A, 104B) could be achieved via at least one of additive manufacturing, subtractive manufacturing, threaded rod, flanged rod, welded rod, etc.

[0097] Referring to FIG. 16, a device 300 comprises the first expander body 102 and the second expander body 108. The first expander body 102 comprises the first sleeve 110A and the first alignment rod 104A. The second expander body 108 comprises a second alignment rod 104B and the second sleeve 110B. The first sleeve 110A is arranged to receive the second alignment rod 104B and the second sleeve 110B is arranged to receive the first alignment rod 104A.

[0098] The device 300 comprises at least two anchor screws (118A, 118B, 118D, 118E) to anchor the device 300 to the maxilla of the patient. The alignment rods (104A, 104B) are press fit to the respective expander body (102, 108). In another embodiment, the alignment rods (104A, 104B) integrally extend from the respective expander body (102,108). In one embodiment, the alignment rod (104A, 104B) is a unibody alignment rod (104A, 104B). In one embodiment, the unibody alignment rod (104A, 104B) could be achieved via at least one of additive manufacturing, subtractive manufacturing, threaded rod, flanged rod, welded rod, etc.

[0099] Referring to FIG. 16 and FIG. 17, the device 300 further comprises an expansion screw assembly 148. The expansion screw assembly 148 comprises an intermediate activation member 150. The activation member 150 comprises a taper portion 152 extend from the first and second sides of the intermediate activation member 150. The first threaded portion 122 extends from the taper portion 152 at the first side of the intermediate activation member 150 and the second threaded portion 124 extends from the taper portion 152 at the second side of the intermediate activation member 150. The first side is opposite to the second side of the intermediate activation member 150. The first threaded portion 122 is received within the first threaded hole 106 and the second threaded portion 124 is received within the second threaded hole 112.

[00100] The taper portion 152 of the expansion screw assembly 148 and the at least two taper portions (158, 160) of the expansion screw assembly 120 aid in providing a robust structure to the device (100, 200, 300). The taper portions (152, 158, 160) is configured to seamlessly allow to fit at the starting position. An additional radius may be added adjacent to the taper portions (152, 158, 160) for even more robust force distribution and strength. The taper portions (152, 158, 160) allow for not only an enhanced mechanical structure due to adding material and force distribution in the high stress area of the assembly (148, 120), but it critically substantially reinforces the intermediate activation member (150, 156) such that much higher forces may be applied with the activation wrench. This allows for more patients to be successfully treated with maxillary skeletal expansion with better results. The intermediate activation member (150, 156) has a hexagon shape.

[00101] Referring to FIG. 18 to FIG. 22, the device (400, 500) comprises the first expander body 102 and the second expander body 108. The first expander body 102 comprises the first sleeve 110A. The second expander body 108 comprises the second alignment rod 104B. The first sleeve 110A is arranged to receive the second alignment rod 104B. The alignment rod (104A, 104B) is a unibody alignment rod (104A, 104B). In one embodiment, the unibody alignment rod (104A, 104B) could be achieved via at least one of additive manufacturing, subtractive manufacturing, threaded rod, flanged rod, welded rod, etc. The device (400, 500) further comprises the first anchor body 132 and the second anchor body 134. The first expander body 102 is mounted over the first anchor body 132 and the second expander body 108 is mounted over the second anchor body 134. One or more assembly screw (116A, 116B, 116C, 116D) fastens the first expander body 102 over the first anchor body 132 and the second expander body 108 over the second anchor body 134. One or more anchor screws (118A, 118B, 118C, 118D, 118E, 118F) extend from the first anchor body 132 and the second anchor body 134 to attach the device 100 to the maxilla of a patient.

[00102] Referring to FIG. 14 and FIG. 19, the device (200,400) comprises an expansion screw assembly 140 including the first threaded portion 122 and the second threaded portion 124 extends from the respective first and second sides of the screw assembly 140. Referring to FIG. 20, the device 400 further comprises at least one sleeve member (142A, 142B) to enclose the threaded portion (122,124) of an expansion screw assembly 140. The threaded portion (122, 124) of the expansion screw assembly 140 is received within the respective first threaded hole 106 and the second threaded hole 112. The expansion screw assembly 140 comprises an intermediate activation member 146. The intermediate activation member 146 has a hexagon shape. In another embodiment, the intermediate activation member (146, 150, 156) may have any other shapes which falls under the scope of this invention.

[00103] Referring to FIG. 22 and FIG. 23, the threaded portion (168, 170) of the expansion screw assembly 162 received within the respective first threaded hole 106 and the second threaded hole 112. In one embodiment, the expansion screw assembly 120 is an adjustable expander. The expansion screw assembly 120 comprises any expansion mechanism that pushes the anchor body (132, 134) from one another. The adjustable expander could include at least one of different style of expanders, expansion screw styles, and expansion mechanisms. The expansion screw assembly 162 comprises an intermediate activation member 172. The intermediate activation member 172 extends from the first expander body 102 to the second expander body 108. The long hollow cylinder of the intermediate activation member 172 substantially enhances strength of the device 500.

[00104] Advantageously, the integral alignment rods (104A, 104B) enable better alignment and mechanical performance during the clinical application of the device (100, 200, 300, 400, 500). The device (100, 200, 300, 400, 500) is configured to withstand the bending / moment arm forces that result from the expansion force being applied to the bone anchorage with a significant air gap from the level of the bone anchorage to the device (100, 200, 300, 400, 500) where the force is being applied. The maxillary expander device (100, 200, 300, 400, 500) is a telescopic expander device.

[00105] Further, the integral alignment rods (104A, 104B) enable the sleeves (110A, HOB) to extend toward the center of the palate where the bending / moment forces are the highest during maxillary skeletal expansion. During Maxillary skeletal expansion the resistance from the Zygomatic Buttress complex especially results in large bending forces on the device (100, 200, 300, 400, 500) until the suture is successfully split, especially in older patients.

[00106] The sleeves (110A, 110B) have a square-shaped cross-section to resist bending forces. Due to the extreme strength of the sleeves (110A, HOB), the inner diameter of the alignment rods (104A, 104B) could be substantially increased, which results in a more robust structure and better mechanical performance for the application of maxillary skeletal expansion.

[00107] The robust structure of the device (100, 200, 300, 400, 500) reduces complications during and after the application of the device (100, 200, 300, 400, 500) to both the patient and clinician. The integral alignment rod (104A, 104B) combined with a telescopic expansion screw assembly (140,148,120,162) substantially enhances the mechanical integrity of the device (100, 200, 300, 400, 500) which expands clinical benefits for patients and clinicians.

[00108] The device (100,200, 300,400,500) includes at least one alignment rod (104A, 104B) for certain cases with less maxillary resistance, such as younger patients or patients with surgical assist. The use of a single alignment rod (104A, 104B) allows for space for inclusion of an aperture in the maxillary expander for attachment of appliances, namely a protraction wire that can insert into the maxillary expander device (100, 200, 300, 400, 500). The integral alignment rod (104A, 104B) helps to align components of the device (100, 200, 300,400, 500) during the application of protraction forces.

[00109] Referring to FIG. 24 to FIG. 29, the present invention discloses a maxillary expander device 600 having integral alignment rods and enhanced expansion screw assembly, according to another embodiment of the invention. The device 600 comprises a first expander body 102 and a second expander body 108. The first expander body 102 comprises a first sleeve 110A and a first alignment rod 104A. The second expander body 108 comprises a second alignment rod 104B and a second sleeve HOB. The first sleeve 110A is arranged to receive the second alignment rod 104B and the second sleeve HOB is arranged to receive the first alignment rod 104A. In one embodiment, the sleeves (110A, 110B) of the device 600 have a square-shaped cross-section and alignment rods (104A, 104B) of the device 600 have a circular-shaped cross-section. The sleeves (110A, HOB) and alignment rods (104A, 104B) may have any shape. In another embodiment, sleeves (110A, 110B) and alignment rods (104A, 104B) may have a pentagon shape or a hexagon shape. The alignment rod (104A, 104B) is a unibody alignment rod (104A, 104B). In one embodiment, the unibody alignment rod (104A, 104B) could be achieved via at least one of additive manufacturing, subtractive manufacturing, threaded rod, flanged rod, welded rod, etc.

[00110] The first sleeve 110A integrally extends from the first expander body 102. The first sleeve 110A and the first expander body 102 together defines a substantial L-shape. A portion at which the first sleeve 110A extends from the first expander body 102 is referred as a first intersection portion.

[00111] The second alignment rod 104B extends from the second expander body 108. The second alignment rod 104B and the second expander body 108 together defines a substantial L shape. A portion at which the second alignment 104B intersects with the second expander body is referred as a second intersection portion.

[00112] Referring to FIG. 26, the first expander body 102 comprises a first threaded hole 106 and the second expander body 108 comprises a second threaded hole 112. The first threaded hole 106 is formed such that an axis of the first threaded hole 106 is parallel to an axis of the first alignment rod 104A. 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 104B. The first threaded hole 106 and the second threaded hole 112 lie on a same axis.

[00113] Referring to FIG. 24 to FIG. 26, the device 600 further comprises an expansion screw assembly 174. The expansion screw assembly 174 is disposed between the first expander body 102 and the second expander body 108. The expansion screw assembly 174 is coaxial to the first threaded hole 106 and the second threaded hole 112.

[00114] Referring to FIG. 24 to FIG. 29, the device 600 further comprises a protraction wire support assembly including a first wire support assembly 176 and a second wire support assembly 178. The first wire support assembly 176 extends from a portion proximal to the first intersection portion. Further, the first wire support assembly 176 extends perpendicular to the first expander body 102.

[00115] The second wire support assembly 178 extends from a portion proximal to the second intersection portion. Further, the second wire support assembly 178 extends perpendicular to the second expander body 108. The protraction wire support assembly is arranged such that the first wire support assembly 176 is opposite and parallel to the second wire support assembly 178. Further, the protraction wire support assembly is formed between the expansion screw assembly 182, and the first sleeve 110A and a first alignment rod 104A. The first wire support assembly 176 and the second wire support assembly 178 comprises holes 180 to receive one or more protraction wires. The protraction wire support assembly is configured to support and fasten one or more protraction wires to apply forward traction, protraction and midfacial advancement forces. The unique location of the protraction wire assembly provides a compact device 600. Further, the location of the protraction wire assembly increases the strength to the device 600.

[00116] The protraction wire support assembly is configured to receive the protraction wire in a horizontal orientation. The horizontal configuration of the protraction wire is an optimal configuration, which provides stability and also compactness to the arrangement of wires. In another embodiment, the protraction wire support assembly is configured to receive the protraction wire in a vertical orientation. In yet another embodiment, depending on the orientation of the holes 180, the protraction wire support assembly is configured to receive the protraction wire in any orientation. The protraction wire support assembly could have any type of coupling mechanism to fasten the protraction wire to the device 600. In one embodiment, the coupling mechanism comprises hole and shaft connection. Other conventional coupling mechanisms are within the scope of this invention.

[00117] Referring to FIG. 24 to FIG. 26, FIG. 30 and FIG. 31, the expansion screw assembly 174 comprises an intermediate activation member 182, a first rod member 184 and a second rod member 186. The intermediate activation member 182 comprises a first end portion and a second end portion opposite to the second end portion. The first rod member 184 movably extends between the first end portion of the intermediate activation member 182 and the first threaded hole 106. The second rod member 186 movably extends between the second end portion of the intermediate activation member 182 and the second threaded hole 112.

[00118] Referring to FIG. 30 to FIG. 33, the expansion screw assembly 174 comprises an intermediate activation member 182. The intermediate activation member 182 is an elongated hollow member. The intermediate activation member 182 comprise an interior hollow portion 189 comprising a number of inner threads 194. The interior hollow portion 189 herein after referred as hollow portion 189. The inner threads 194 are formed at the hollow portion 189 of the intermediate activation member 182. The inner threads 194 extend along a length of at least a portion of the hollow portion 189. In this embodiment, the inner threads 194 extend along the length of the hollow portion 189. The hollow portion 189 comprises a first hollow portion 190 and a second hollow portion 192 integrally extending from the first hollow portion 190. The first hollow portion 190 comprises a first inner diameter and the second hollow portion 192 comprises a second inner diameter. The first inner diameter is different than the second inner diameter. In this embodiment, the first inner diameter meter is smaller than the second inner diameter.

[00119] The first rod member 184 comprises a first threaded portion 196. The first threaded portion 196 comprises a plurality of first threads formed at an exterior portion of the first rod member 184. The second rod member 186 comprises a first portion 198 configured to receive within the hollow portion 189 via the second end portion of the intermediated activation member 182. The first portion 198 comprises a third hollow portion 200 and a second threaded portion 202. The second threaded portion 202 comprises a plurality of second threads at an exterior side of the first portion 198. The plurality of second threads extends along a length of at least a portion of the second rod member 186. The first portion 198 of the second rod member 186 is complementary to the second hollow portion 192 of the intermediate activation member 182.

[00120] The first rod member 184 passes through the first hollow portion 190 of the intermediate activation member 182 and received within the third hollow portion 202 of the second rod member 186. The cross-section of the first threaded portion 196 is complementary to the cross-section of the first hollow portion 190 of the intermediate activation member 182, which enables the first threaded portion 196 to pass through the first hollow portion 190. Further, a diameter of the first threaded portion 196 is smaller than a diameter of the second hollow portion 198 of the intermediate activation member 182 and a diameter of the third hollow portion 200 of the second rod member 186, which enables the first threaded portion 196 to receive within the third hollow portion 200 of the second rod member 186 disposed within the intermediate activation member 182.

[00121] On activating the intermediate activation member 182, the first threads of the first rod member 184 reversely threads over the inner threads 194 of the first hollow portion 190 and telescopically retracts from the third hollow portion 200 of the second rod member 186 and the hollow portion 186 of the intermediate activation member 182. Simultaneously, the second threads of the second rod member 186 reversely threads over the inner threads 194 of the second hollow portion 192 of the intermediate activation member 182 and telescopically retracts via the second end portion of the intermediate hollow member 182.

[00122] In one embodiment, the first rod member 184 and the second rod member 186 are locked to the first and second expander body (102, 108), respectively, via a locking module. The locking module is configured with a press fit locking mechanism. In another embodiment, the locking module comprises flanges to lock the first and second rod member (184, 186) to the first and second expander body (102, 108), respectively. In yet another embodiment, the locking module comprises threaded fasteners to lock the first and second rod member (184, 186) to the first and second expander body (102, 108), respectively. In yet another embodiment, the first rod member 184 and the second rod member 186 are locked to the first and second expander body (102, 108), respectively, via laser weld. The device 600 could have any other type of locking module. The rod members (184, 186) locked with the expander body (102, 108) also provides stability to the device 600. In yet another embodiment, the rod members (184, 186) and the expander body (102, 108) could be provided as a single integral unit.

[00123] Referring to FIG. 24 to FIG. 27, the device 600 further comprises a first anchor body 132 and a second anchor body 134. The first expander body 102 is mounted over the first anchor body 132 and the second expander body 108 is mounted over the second anchor body 134. One or more assembly screw (116A, 116B, 116C, 116D) fastens the first expander body 102 over the first anchor body 132 and the second expander body 108 over the second anchor body 134. In one embodiment, the expansion screw assembly 120 is an adjustable expander. The expansion screw assembly 120 comprises any expansion mechanism that pushes the anchor body (132, 134) from one another. The adjustable expander could include at least one of different style of expanders, expansion screw styles, and expansion mechanisms.

[00124] The first expander body 102 comprises one or more first assembly holes (114A, 114B) and the first anchor body 132 comprises one or more second assembly holes (126A, 126B). One or more assembly screws (116A, 116B) fasten the first expander body 102 to the first anchor body 132 via one or more first assembly holes (114A, 114B) and one or more second assembly holes (126A, 126B). The second expander body 108 comprises one or more first assembly holes (114C, 114D) and the first anchor body 132 comprises one or more second assembly holes (126C, 126D). One or more assembly screws (116C, 116D) fasten the second expander body 108 to the second anchor body 134 via one or more first assembly holes (114C, 114D) and one or more second assembly holes (126C, 126D). The assembly holes (114A, 114B, 114C, 114D) shown in FIG. 26, and the assembly hole (126A, 126B, 126C, 126D) shown in FIG. 26.

[00125] In another embodiment, the expander body (102,108) is mounted to the anchor body (132, 134) by any other conventional fastening means. In one embodiment, the alignment rods (104A, 104B) are configured to telescope through the sleeves (110A, HOB). In one embodiment, the alignment rods (104A, 104B) are press fit to the respective expander body (102, 108). The alignment rod (104A, 104B) integral to the respective expander body (102, 108) is a unibody alignment rod (104A, 104B). In one embodiment, the unibody alignment rod (104A, 104B) could be achieved via at least one of additive manufacturing, subtractive manufacturing, threaded rod, flanged rod, welded rod, etc. Further, one or more anchor screws (118A, 118B, 118C, 118D, 118E, 118F) extend from the first anchor body 132 and the second anchor body 134 to attach the device 600 to the maxilla of a patient. Optionally the device 600 may or may not include molar attachments to the teeth or attachments to the side palate.

[00126] Advantageously, the unibody alignment rods (104A, 104B) enable better alignment and mechanical performance during the clinical application of the device 600. The device 600 is configured to withstand the bending / moment arm forces that result from the expansion force being applied to the bone anchorage with a significant air gap from the level of the bone anchorage to the device 600 where the force is being applied. The maxillary expander device 600 is a telescopic expander device.

[00127] Further, the unibody alignment rods (104A, 104B) enable the sleeves (110A, HOB) to extend toward the center of the palate where the bending / moment forces are the highest during maxillary skeletal expansion. During Maxillary skeletal expansion the resistance from the Zygomatic Buttress complex especially results in large bending forces on the device 600 until the suture is successfully split, especially in older patients.

[00128] The sleeves (110A, 110B) have a square-shaped cross-section to resist bending forces. Due to the extreme strength of the sleeves (110A, HOB), the inner diameter of the alignment rods (104A, 104B) could be substantially increased, which results in a more robust structure and better mechanical performance for the application of maxillary skeletal expansion.

[00129] The robust structure of the device 600 reduces complications during and after the application of the device 600 to both the patient and clinician. The unibody alignment rod (104A, 104B) combined with a telescopic expansion screw assembly (140, 148, 120, 162) substantially enhances the mechanical integrity of the device 600 which expands clinical benefits for patients and clinicians. The device 600 includes at least one alignment rod (104A, 104B) for certain cases with less maxillary resistance, such as younger patients or patients with surgical assist. The use of a single alignment rod (104A, 104B) allows for space for inclusion of an aperture in the maxillary expander for attachment of appliances, namely a protraction wire that can insert into the maxillary expander device 600. The unibody alignment rod (104A, 104B) helps to align components of the device 600 during the application of protraction forces.

[00130] Referring to FIG. 34, FIG. 35, and FIG. 36, the present invention discloses a patient-specific midfacial expander device 700, according to yet another embodiment of the present invention. The midfacial expander device 700 is a customizable unibody, midfacial expander device 700. The device 700 comprises a first expander body 102 and a second expander body 104. The first expander body 102 comprises a first base 170A having a first side and a second side opposite to the first side. The first expander body 102 further comprises a first sleeve 106A and a first alignment rod 108 A. The first sleeve 106A extends from the first side of the first base 170A and the first alignment rod 108A extends from the second side of the first base 170B. The first expander body 102 is arranged parallel to the second expander body 104. The second expander body 104 comprises a second base 170B having a first side and a second side. The second expander body 104 further comprises a second alignment rod 108B and a second sleeve 106B. The second alignment rod 108B extends from the first side of the second base 170B and the second sleeve 106B extends from the second side of the second base 170B. The first sleeve 106A is arranged to receive the second alignment rod 108B and the second sleeve 106B is arranged to receive the first alignment rod 108 A.

[00131] The first sleeve 106A and second sleeve 106B have an interior hollow portion having a cross-section complementary to the first alignment rod 108A and the second alignment rod 108B, respectively. In one embodiment, the first and second sleeves (106A, 106B) of the device 700 have at least one of a square shaped cross-section, a circular shaped cross-section, a hexagon shaped cross-section and a pentagon shaped cross-section at an exterior side of the first and second sleeves (106A, 106B). In one embodiment, the first alignment rod 108A and the second alignment rod 108B have a circular shaped cross-section. The interior hollow portion of the first sleeve 106A and the second sleeve 106B have a circular shaped cross-section. In another embodiment, the exterior portion of the sleeves (106A, 106B), the interior hollow portion of the sleeves (106A, 106B) and alignment rods (108A, 108B) may have any shape.

[00132] 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 108A. 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 is coaxial to the second threaded hole 112.

[00133] The device 700 further comprises an expansion screw assembly 114. The expansion screw assembly 114 comprises an intermediate activation member 116, a first threaded portion 122 and the second threaded portion 124. The intermediate activation member 116 further comprises at least one tapered portion (118, 120) extending from each side of the intermediate activation member 116. The first threaded portion 122 extends from the tapered portion 118 at a first side of the intermediate activation member 116 and the second threaded portion 124 extends from the tapered 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.

[00134] In another embodiment, the intermediate activation member 116 comprises at least two tapered portions extending from each side of the intermediate activation member 116, and the first and second threaded portion (122, 124) extends from the tapered portions from each side of the intermediate activation member 116.

[00135] The device 700 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, 130B, 130C, 130D) fasten the first expander body 102 over the first anchor body 126 and the second expander body 104 over the second anchor body 128. In one embodiment, the expansion screw assembly 120 is an adjustable expander. The expansion screw assembly 120 comprises any expansion mechanism that pushes the anchor body (126, 128) from one another. The adjustable expander could include at least one of different style of expanders, expansion screw styles, and expansion mechanisms.

[00136] The first expander body 102 comprises one or more first threaded assembly holes (132A, 132B) and the first anchor body 126 comprises one or more second threaded assembly holes (132C, 132D). The first threaded assembly holes (132A, 132B) are arranged complementary to the arrangement of the second threaded assembly holes (132C, 132D). One or more assembly screws (130A, 130B) fasten the first expander body 102 to the first anchor body 126 via one or more first threaded assembly holes (132A, 132B) and one or more second threaded assembly holes (132C, 132D). The second expander body 104 comprises one or more third threaded assembly holes (134A, 134B) and the second anchor body 128 comprises one or more fourth threaded assembly holes (134C, 134D). The third threaded assembly holes (134A, 134B) are arranged complementary to the arrangement of the fourth threaded assembly holes (134C, 134D). One or more assembly screws (130C, 1300) fasten the second expander body 104 to the second anchor body 128 via one or more third assembly holes (134A, 134B) and one or more fourth threaded assembly holes (134C, 134D).

[00137] In another embodiment, the expander body (102, 104) is mounted to the expander anchor body (126, 128) by any other conventional fastening means. In one embodiment, the alignment rods (108A, 108B) are configured to telescope through the sleeves (106A, 106B). In one embodiment, the alignment rods (108A, 108B) are press fit connected to the respective expander body (102, 104). In another embodiment, the alignment rods (108 A, 108B) integrally extend from the respective expander body (102, 104). The alignment rod (108A, 108B) integral to the respective expander body (102, 148) is a unibody alignment rod (108A, 108B). In one embodiment, the unibody alignment rod (108A, 108B) could be achieved via at least one of additive manufacturing, subtractive manufacturing, threaded rod, flanged rod, welded rod, etc. 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 700 to the maxilla of a patient. The first anchor body 126 comprises one or more first threaded anchor holes (136A, 136B, 136C) and the second anchor body 128 comprises one or more second threaded anchor holes (136D, 136E, 136F). The first threaded anchor holes (136A, 136B, 136C) and the second threaded anchor holes (136D, 136E, 136F) are configured to receive one or more anchor screws (138A, 138B, 138C, 138D, 138E, 138F) to fix the device 700 to the maxilla of the patient. Optionally the device 700 may or may not include molar attachments to the teeth or attachments to the side palate.

[00138] FIG. 37 exemplarily illustrates a side view of the midfacial skeletal expander device 700 of FIG. 34. The device 700 comprises the first expander body 102 supported by the first anchor body 126. Referring to FIG. 34 to FIG. 40, the device 700 comprises one or more temporary anchorage assemblies 140. The temporary anchorage assemblies 140 are fixed to the device 700 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 first support member 142 is attached to exterior side of the first anchor body 126. The exterior side defines an outer surface of the first anchor body 126 opposite to a side of the first sleeve 106A and the first alignment rod 108A. The first support member 142 is configured to angularly support at least two temporary anchorage assemblies 140.

[00139] The second support member 144 is attached to the second anchor body 128. In one embodiment, the second support member 144 is attached to an exterior side of the second anchor body 128. The second support member 144 is configured to angularly support at least two temporary anchorage assemblies 140. The exterior side of the second anchor body 128 defines an outer surface of the second anchor body 128 opposite to a side of the second sleeve 106B and the second alignment rod 108B. The first support member 142 and the second support member 144 are customizable for placement of the temporary anchorage assemblies 140 at a desired position of the maxilla of the patient

[00140] The device 700 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 member (142, 144) comprises one or more holes 166 arranged complementary to the flange members 164 of the first and second anchor body (126,128), which facilitates the support members (142,144) to fix over respective flange member 164. The flange members 164 on the first and second expander anchor body (126,128) allow for unibody strength with the custom part comprising the support members (142, 144). The flange members 164 could be in multiple configurations and shapes and allows a seamless weld of custom part with extreme strength.

[00141] 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. Referring to FIG. 38, each hollow locking member 148 comprises a cylindrical portion 150 and a flange 162. The cylindrical portion 150 comprises a plurality of first threads 152 at an interior side of the cylindrical portion 150. Referring to FIG. 39 and FIG. 40, the first support member 142 is configured to support at least two temporary anchorage assemblies 140.

[00142] Referring to FIG. 40, the temporary anchorage screw 146 comprises a head portion 154 having a plurality of second threads 156 at an exterior surface of the head portion 154. The second threads 156 extend along at least a portion of the head portion 154. 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 the flange 162. The device 700 comprises flange member 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 bodies (126, 128).

[00143] FIG. 41 shows 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 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 via assembly screws (130A, 130B) and the second expander body 104 is mounted over the second anchor body 128 via assembly screws (130C, 130D). The support members (142, 144) are configured to support respective hollow locking member 148. In one embodiment, the device 700 comprises at least one alignment rod locked, and at least one expansion screw. In one embodiment, the expansion screw assembly 120 is an adjustable expander. The expansion screw assembly 120 comprises any expansion mechanism that pushes the anchor body (126, 128) from one another. The adjustable expander could include at least one of different style of expanders, expansion screw styles, and expansion mechanisms. Also, it should be emphasized that the alignment rod is configured to be a rigid uniconstruct with the expander body. It can be done through many manufacturing methods including additive manufacturing, but the concept of being unibody with the expander is the main feature. The patient-specific midface expander (700, 800) can be made by additive manufacturing, i.e., 3d mental printing the threads and part all as one, instead of threaded inserts, or even thread could be drilled directly into the part custom each one, rather than our thread insert strategy.

[00144] Referring FIG. 41 and FIG. 42, the device 700 further comprises one or more predrill abutment tube member 158 (hereinafter referred as tube member 158). The tube member 158 comprises a plurality of third threads 160 at an exterior surface of tube member 158. The tube member 158 is configured to lock with the respective hollow locking member 148. The third threads 160 of the tube member 158 thread over at least a portion of the first threads 152 of the hollow locking member 148, thereby locking the tube member 158 with the respective hollow locking member 148. The tube member 158 is used to guide a pilot drill. During application of the device 700, the tube member 158 is screwed to the hollow locking member 148 to guide the pilot drill. Thereafter, the tube member 158 is removed from the device 700 and the TADs 146 are positioned and locked with the hollow locking member 148.

[00145] Referring to FIG. 43 and FIG. 44, a patient-specific midfacial expander device 800 with locked alignment rods comprises a first expander body 102 and a second expander body 104. The first expander body 102 comprises a first base 170A having a first side and a second side opposite to the first side. The first expander body 102 further comprises a first sleeve 106A and a first alignment rod 108A. The first sleeve 106A extends from the first side of the first base 170A and the first alignment rod 108A extends from the second side of the first base 170B. The first expander body 102 is arranged parallel to the second expander body 104. The second expander body 104 comprises a second base 170B having a first side and a second side. The second expander body 104 further comprises a second alignment rod 108B and a second sleeve 106B. The second alignment rod 108B extends from the first side of the second base 170B and the second sleeve 106B extends from the second side of the second base 170B. The first sleeve 106A is arranged to receive the second alignment rod 108B and the second sleeve 106B is arranged to receive the first alignment rod 108A. The first sleeve 106A and second sleeve 106B have an interior hollow portion having a cross-section complementary to the first alignment rod 108A and the second alignment rod 108B, respectively. In one embodiment, the first and second sleeves (106A, 106B) of the device 800 have at least one of a square shaped cross-section, a circular shaped cross-section, a hexagon shaped cross-section and a pentagon shaped crosssection at an exterior side of the first and second sleeves (106A, 106B). In one embodiment, the first alignment rod 108A and the second alignment rod 108B have a circular shaped cross-section. The interior hollow portion of the first sleeve 106A and the second sleeve 106B have a circular shaped cross-section. In another embodiment, the exterior portion of the sleeves (106A, 106B), the interior hollow portion of the sleeves (106A, 106B) and the alignment rods (108A, 108B) may have any shape.

[00146] 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 108A. 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 is coaxial to the second threaded hole 112.

[00147] The device 800 further comprises an expansion screw assembly 114. The expansion screw assembly 114 comprises an intermediate activation member 116, a first threaded portion 122 and the second threaded portion 124. The intermediate activation member 116 further comprises at least one tapered portion (118, 120) extending from each side of the intermediate activation member 116. The first threaded portion 122 extends from the tapered portion 118 at a first side of the intermediate activation member 116 and the second threaded portion 124 extends from the tapered 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.

[00148] In another embodiment, the intermediate activation member 116 comprises at least two tapered portions extending from each side of the intermediate activation member 116, and the first and second threaded portion (122, 124) extends from the tapered portions from each side of the intermediate activation member 116.

[00149] The device 800 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, 130B, 130C, 130D) fasten the first expander body 102 over the first anchor body 126 and the second expander body 104 over the second anchor body 128. In one embodiment, the expansion screw assembly 120 is an adjustable expander. The expansion screw assembly 120 comprises any expansion mechanism that pushes the anchor body (126, 128) from one another. The adjustable expander could include at least one of different style of expanders, expansion screw styles, and expansion mechanisms.

[00150] The first expander body 102 comprises one or more first threaded assembly holes (132A, 132B) and the first anchor body 126 comprises one or more second threaded assembly holes (132C, 132D). The first threaded assembly holes (132A, 132B) are arranged complementary to the arrangement of the second threaded assembly holes (132C, 132D). One or more assembly screws (130A, 130B) fasten the first expander body 102 to the first anchor body 126 via one or more first threaded assembly holes (132A, 132B) and one or more second threaded assembly holes (132C, 132D). The second expander body 104 comprises one or more third threaded assembly holes (134A, 134B) and the second anchor body 128 comprises one or more fourth threaded assembly holes (134C, 134D). The third threaded assembly holes (134A, 134B) are arranged complementary to the arrangement of the fourth threaded assembly holes (134C, 134D). One or more assembly screws (130C, 130D) fasten the second expander body 104 to the second anchor body 128 via one or more third threaded assembly holes (134A, 134B) and one or more fourth threaded assembly holes (134C, 134D).

[00151] In another embodiment, the expander body (102, 104) is mounted to the expander anchor body (126, 128) by any other conventional fastening means. In one embodiment, the alignment rods (108A, 108B) are configured to telescope through the sleeves (106A, 106B). In one embodiment, the alignment rods (108A, 108B) are press fit to the respective expander body (102, 104). In another embodiment, the alignment rods (108A, 108B) integrally extend from the respective expander body (102, 104). The alignment rod (108A, 108B) integral to the respective expander body (102, 148) is a unibody alignment rod (108A, 108B). In one embodiment, the unibody alignment rod (108A, 108B) could be achieved via at least one of additive manufacturing, subtractive manufacturing, threaded rod, flanged rod, welded rod, etc. 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 800 to the maxilla of a patient. The first anchor body 126 comprises one or more first threaded anchor holes (136A, 136B, 136C) and the second anchor body 128 comprises one or more second threaded anchor holes (136D, 136E, 136F). The first threaded anchor holes (136A, 136B, 136C) and the second threaded anchor holes (136D, 136E, 136F) are configured to receive one or more anchor screws (138A, 138B, 138C, 138D, 138E, 138F) to fix the device 800 to the maxilla of the patient. Optionally the device 800 may or may not include molar attachments to the teeth or attachments to the side palate.

[00152] Referring to FIG. 14 to FIG. 49, the device 800 further comprises at least two blocks (168A, 168B). At least one block 168A extends perpendicularly from a midportion of the first sleeve 106A and at least one block 168B extends perpendicularly from a midportion of the second sleeve 106B. In an embodiment, each block (168 A, 168B) has a wedge shape at a free end. The blocks (168A, 168B) are configured to massively resist the shear force from midfacial expansion.

[00153] In one embodiment, the blocks (168A, 168B) 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 (168A, 168B) 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 (168A, 168B) acts to provide a counter-reactionary force during midfacial expansion. By virtue of this inherent characteristic, the TAD 146 and / or anchor bodies (102, 104) 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 146 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.

[00154] Referring to FIG. 46 to FIG. 49, the first expander body 102 is mounted over the first anchor body 126, the second expander body 104 is mounted over the second anchor body 128 and the intermediate activation member 116 to activate the expansion screw assembly 114 (shown in FIG. 44) 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 respective temporary 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 800 to the maxilla of a patient.

[00155] Referring to FIG. 43 and FIG. 44, and FIG. 46 to FIG. 49, the device 800 comprises one or more temporary anchorage assemblies 140. The temporary anchorage assemblies 140 are fixed to the device 800 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 first support member 142 is attached to exterior side of the first anchor body 126. The exterior side defines an outer surface of the first anchor body 126 opposite to the first sleeve 106A and the first alignment rod 108A. The first support member 142 is configured to angularly support at least two temporary anchorage assemblies 140.

[00156] The second support member 144 is attached to the second anchor body 128. In one embodiment, the second support member 144 is attached to an exterior side of the second anchor body 128. The second support member 144 is configured to angularly support at least two temporary anchorage assemblies 140. The exterior side of the second anchor body 128 defines an outer surface of the second anchor body 128 opposite to a side of the second sleeve 106B and the second alignment rod 108B. The first support member 142 and the second support member 144 are customizable for placement of the temporary anchorage assemblies 140 at a desired position of the maxilla of the patient. 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 expander anchor body (126, 128) of the device 800.

[00157] Referring to FIG. 44, the device 800 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 member (142, 144) comprises one or more holes 166 arranged complementary to the flange members 164 of the anchor body (126, 128), which facilitates the support members (142, 144) to fix over respective flange member 164. The flange members 164 on the first and second anchor bodies (126, 128) allow for unibody strength with the custom part comprising the support members (142, 144). The flange members 164 could be in multiple configurations and shapes and allows a seamless weld of custom part with extreme strength.

[00158] 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 assemblies 140.

[00159] 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 800 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 bodies (126, 128).

[00160] The device 800 further comprises one or more predrill abutment tube member (hereinafter 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 800, 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 800 and the TADs 146 are positioned and locked with the hollow locking member 148. It is to be understood that in device 800, the predrill abutment tube member with the third threads, the head portion of the temporary anchorage screw 146, and the cylindrical portion and the flange of the hollow locking member 148 are the same components as those shown in device 700. For a clearer understanding of these mentioned components, reference shall be made to FIG. 36.

[00161] Referring to FIG. 34 to FIG. 49, the placement of the TAD 146 could be customized and locked in position with full strength. The device (700, 800) 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 (700, 800) and the bone. The device (700, 800) provides expansive forces to the TAD 146 in order to split the palate. The temporary anchorage assembly 140 and support members (142, 144) are also referred as patient-specific custom anchor bodies (140, 142, 144).

[00162] 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.

[00163] 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 (700, 800) 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 (700, 800).

[00164] 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 (700, 800) 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.

[00165] The tube member 158 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 (700, 800) comprises custom placed TADs 146 and locked in position with full strength.

[00166] Referring to FIG. 7 to FIG. 49, the unibody alignment rod (104A, 104B, 108A, 108B) and the custom part or support members (142, 144) could be applied as a single level design. Further, the unibody alignment rod (104A, 104B, 108A, 108B), the custom part or support members (12, 144) and robust stacked design with retaining screws attaching the adjustable expander module to the anchor bodies (126, 128, 132, 134) could be applied as a single level design.

[00167] The present invention could use any other mechanisms to attach or couple the adjustable expander (or expansion screw assembly (120, 148, 120, 140, 162, 172, 114)) to the respective anchor bodies (126, 128, 132, 134) and expander body (102, 108, 104) than the retaining screws. For example, welding the adjustable expander to the anchor bodies could be used, or they can all be manufactured as one unit.

[00168] The present inventions further disclose a method for developing the device (100 to 800). The method involves utilizing patent imaging data, including, but not limited to, x-ray, CT scans, MRI, palatal scans, impressions, software algorithm is employed to identify and determine precise locations within the maxilla / midpalatal region for stable bone anchorage. This data serves as the basis for fabricating custom parts, denoted as (142,144), precisely tailored to facilitate the placement of bone screws in predetermined locations unique to each patient.

[00169] Furthermore, the custom part will include either the threaded insert (142, 144), or it will be additively manufactured with the internal thread, or the thread will be tapped directly into each hole custom for the patient. Resultantly, patient-specific custom anchor bodies (142, 144, 140) are created, featuring a plurality of internally threaded holes specifically configured for secure attachment on both sides of the maxilla / midpalatal suture. These anchor bodies (142,144,140) are intended for fixation using bone screws with external threads, ensuring robust and personalized anchorage.

[00170] Furthermore, these patient-specific, custom threaded anchor bodies (142, 144, 140) are designed for integration with an "adjustable expander" through diverse coupling mechanisms, such as retaining screws, welding, or a unified unibody structure. The objective is to form a unibody construct, comprising the custom anchor bodies seamlessly connected to an adjustable expander, facilitating orthodontic procedures with enhanced precision and patient-specific adaptability.

[00171] 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.

[00172] 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.

[00173] 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 in the art to understand the disclosure for various embodiments with various modifications as are suited to the particular use contemplated.

Claims

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, 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 secondthreaded portion extends from the second side of the intermediate activation member to the second threaded hole of the second expander body;a first anchor body configured to support the first expander body;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;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, anda 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 the first support member and the second support member are customizable for placement of the temporary anchorage assemblies at a desired position of the maxilla of the patient, and wherein the intermediate activation member on rotation causes bidirectional outward movement of the first expander body, the second expander body and the temporary anchorage assemblies, and exerts outward, lateral force on the patient's palate.

2. The device of claim 1, 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.

3. The device of claim 2, 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.

4. The device of claim 2, further comprises a tube member comprising a plurality of third threads at an exterior surface of tube member, wherein the third threads of the tube member thread over at least a portion of the first threads of the hollow locking member, thereby locking the tube member with the respective hollow locking member, wherein the tube member is configured to guide a pilot drill.

5. The device of claim 1, wherein the first anchor body comprises one or more flange members extends from the exterior side of the first anchor body and the second anchor body.

6. The device of claim 1, 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.

7. The device of claim 1, 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.

8. The device of claim 1, further comprises at least two blocks, wherein at least one block extends perpendicularly from a midportion of the first sleeve and at least one block extends perpendicularly from a midportion of the second sleeve, and wherein each block has a wedge shape at a free end.

9. The device of claim 1, wherein the first sleeve and second sleeve have an interior hollow portion having a cross-section complementary to the first alignment rod and the second alignment rod, respectively.

10. The device of claim 1, wherein the first sleeve and the second sleeve have at least one of a square shaped cross-section, a circular shaped cross-section, a hexagon shaped cross-section and a pentagon shaped cross-section at an exterior side of the first and second sleeves.

11. The device of claim 1, wherein the first alignment rod and the second alignment rod have a circular shaped cross-section, and wherein the alignment rods are integral to the respective expander body is a unibody alignment rod.

12. The device of claim 9, wherein the interior hollow portion of the first sleeve and the second sleeve have a circular shaped cross-section.

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

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

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 more fourth 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.

18. The device of claim 17, 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.

19. 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.

20. A telescopic maxillary expander device, comprising:a first expander body incorporating at least one sleeve and a first alignment rod;a second expander body comprising at least one alignment rod, wherein the first sleeve accommodates the alignment rod, wherein the rod is a unibody alignment rod;a first threaded hole within the first expander body, oriented parallel to the axis of the first alignment rod;a second threaded hole within the second expander body, oriented parallel to the axis of the second alignment rod, with said first and second threaded holes aligned along the same axis, andan adjustable 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 member.

21. The telescopic maxillary expander device of claim 20, further comprising:a first anchor body and a second anchor body over which the first and second expander bodies are respectively mounted, wherein one or more assembly screws fasten the expander bodies over the anchor bodies;one or more anchor screws extending from the first and second anchor bodies to fix the device to the maxilla of the patient, anda protraction wire support assembly positioned between the expansion screw assembly, the first sleeve, and the first alignment rod, configured to support and fasten one or more protraction wires to apply forward traction, protraction, and midfacial advancement forces.

22. The telescopic maxillary expander device of claim 20, 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 at least 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.

23. The telescopic maxillary expander device of claim 20, 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.

24. The telescopic maxillary expander device of claim 20, 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.

25. The telescopic maxillary expander device of claim 20, wherein the first and second rod members are securely locked to the first and second expander bodies through a locking module featuring a press fit mechanism, flanges, threaded fasteners, laser weld, or configured as a single integral unit.

26. A telescopic maxillary expander device comprising:a first expander body with a first sleeve and a first alignment rod;a second expander body comprising a second alignment rod and a second sleeve, wherein the first sleeve accommodates the second alignment rod, and the second sleeve accommodates the first alignment rod, wherein the first expander body comprising a first threaded hole formed parallel to the first alignment rod, and the second expander body comprising a second threaded hole formed parallel to the second alignment rod, aligning on the same axis;an adjustable expansion screw assembly with an intermediate activation member having taper portions on each side, a first threaded portion extendingfrom one side, and a second threaded portion extending from the opposite side, both threaded portions received within the respective threaded holes;a first and second anchor bodies, with the first and second expander bodies respectively mounted over them, secured by assembly screws, andone or more anchor screws extending from the first and second anchor bodies to attach the device to the maxilla of a patient.

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