WO2018109627A1

WO2018109627A1 - Sinus lift device and method

Info

Publication number: WO2018109627A1
Application number: PCT/IB2017/057766
Authority: WO
Inventors: Amnon MOUTSAFI; Eliahu Eliachar; Eran Hirszowicz
Original assignee: Mor Research Applications Ltd.
Priority date: 2016-12-12
Filing date: 2017-12-10
Publication date: 2018-06-21

Abstract

A device for sinus lift following a tearing of the Schneiderian membrane, comprising a biodegradable, multi-lumen balloon. The balloon comprises a first lumen and a second lumen. The first lumen, when inflated, forms a separation barrier and a posterior layer which are substantially perpendicular to one another and extend along a length of the balloon. The second lumen defined by an inferior layer comprising perforations to enable a bone graft formed in the second lumen to mesh with the bony floor of the maxillary sinus. The balloon comprises an inlet cannula in fluid communication with the first lumen, to enable inflation of the first lumen. The balloon comprises at least one connector attached to or integrally formed with the balloon, and adapted or configured to anchor the balloon medially to a rim of a preformed lateral opening in the maxillary sinus.

Description

SINUS LIFT DEVICE AND METHOD

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 62/432,802, filed December 12, 2016, and entitled "Sinus Lift Device and Method", the contents of which are incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

[0002] The invention relates to the field of sinus lift procedures.

BACKGROUND

[0003] Maxillary sinus floor augmentation, such as a sinus lift, a sinus graft, a sinus augmentation, a sinus procedure, and the like, is a surgical procedure to increase the amount of bone in the posterior maxilla (i.e., upper jaw bone), and/or near the premolar and/or molar teeth, by lifting the lower Schneiderian membrane (sinus membrane) and placing a bone graft between the membrane and the implant location. I n anatomy, the Schneiderian membrane is the membranous lining of the maxillary sinus cavity, as described by Boyne et al. in "Grafting of the maxillary sinus floor with autogenous marrow and bone", J Oral Maxillofacial Surgery, 1980, 38, pp:113-116. The bone graft material used may be an autograft, an allograft, a xenograft, an alloplast (a growth-factor infused collagen matrix), synthetic variants, combinations thereof, and the like.

[0004] For example, when a tooth is lost the alveolar process begins to remodel. The vacant tooth socket may collapse as it heals, leaving an edentulous (toothless) area, termed a ridge. This collapse may cause a loss in both height and width of the surrounding bone. I n addition, when a maxillary molar or premolar is lost, the floor of the maxillary sinus may expand, which may further diminish the thickness of the underlying bone. Overall, this may lead to a loss in volume of bone that is available for insertion of dental implants, which may rely on osseointegration (bone integration), to replace missing teeth. The goal of the sinus lift is to graft extra bone into the maxillary sinus, so that more bone may be available to support a dental implant.

[0005] There are several ways to perform sinus augmentation. The procedure is performed from inside the patient's mouth where the surgeon makes an incision into the gum, or gingiva. Once the incision is made, the surgeon then pulls back the gum tissue, exposing the lateral boney wall of the sinus. The surgeon then cuts a "window" to the sinus, which is exposing the Schneiderian membrane. The membrane is separated from the bone on the inferior aspect of the sinus, and bone graft material is placed into the newly created space. The gums are then sutured close and the graft is left to heal for 4-12 months.

[0006] A major risk of a sinus augmentation is that the sinus membrane may be pierced, ripped, or the like. Remedies may include stitching the tear or placing a patch over it. In some cases, the surgery is stopped altogether and the tear is given time to heal, usually three to six months. Often, the sinus membrane grows back thicker and stronger, making success more likely on the second operation. In some cases, the dental implant is also inserted during the same sinus lift procedure.

[0007] The foregoing examples of the related art and limitations related therewith are intended to be illustrative and not exclusive. Other limitations of the related art will become apparent to those of skill in the art upon a reading of the specification and a study of the figures.

SUMMARY

[0008] The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope.

[0009] There is provided, in accordance with an embodiment, a device for sinus lift following a tearing of the Schneiderian membrane. The device comprises a biodegradable, multi-lumen balloon. The balloon comprises a first lumen which is fluid-impermeable or at least liquid impermeable and is pre-shaped to form, when inflated, a separation barrier and a posterior layer which are substantially perpendicular to one another and extend along a length of the balloon. The separation barrier forms a void between a bony floor of a maxillary sinus and the Schneiderian membrane of the maxillary sinus. The separation barrier creates a seal between the void and a volume of the maxillary sinus which lies above the balloon. The balloon comprises a second lumen defined by an inferior layer comprising perforations of diameter between, for example, 0.1 and 1 millimeters and which is permeable to blood vessel formation, to enable a bone graft formed in the second lumen to mesh with the bony floor of the maxillary sinus. The second lumen is larger than the first lumen to comply with the non-planar shape of the bony floor, where the bone graft comprises granules of mean diameter between, for example, 0.4 and 2 millimeters such that the granules are retained with the second lumen. The device comprises an inlet cannula in fluid communication with the first lumen, to enable inflation of the first lumen. The device comprises one or more connectors attached to or integrally formed with the balloon, and adapted or configured to anchor the balloon medially to a rim of a preformed lateral opening in the maxillary sinus, to ensure that a seal is maintained by the separation barrier between the torn Schneiderian membrane and the bone graft.

[0010] In some embodiments, the balloon is elongated, comprising a long dimension and one or more short dimensions, where the long dimension defines a length of the balloon.

[0011] In some embodiments, the balloon is adapted or configured, when deflated, to be rolled or folded along the long dimension, to enable its compact insertion into the maxillary sinus through the preformed lateral opening.

[0012] In some embodiments, the rolling is a double rolling, formed by rolling two opposing ends of the balloon towards approximately a center of the long dimension of the balloon; and the inlet cannula connects to the balloon at approximately the center of the long dimension.

[0013] In some embodiments, the balloon, when deflated, has a maximal length of between 25-45 millimeters, and a maximal width of between 15-35 millimeters. [0014] In some embodiments, the balloon, when inflated, has a maximal length of between 15-40 millimeters, and a maximal width of between 10-30 millimeters.

[0015] In some embodiments, the balloon, when inflated, has a maximal height of between 10-25 millimeters.

[0016] In some embodiments, the balloon, the one or more connector comprises a plurality of straps each emerging from a different location of the balloon.

[0017] In some embodiments, each of the straps comprises one or more of a tack and a hole disposed at an area of the one or more connectors distal to the balloon.

[0018] In some embodiments, the one or more connectors are at least partially of one or more of a biodegradable and a biocompatible material (e.g., biodegradable and biocompatible metal).

[0019] In some embodiments, the second lumen is further defined by one or more of an anterior wall and a posterior wall which is permeable to bone graft, the walls form a corner of the void with the posterior layer and the separation barrier.

[0020] In some embodiments, the inlet cannula is adapted or configured to be dismantled from balloon

[0021] In some embodiments, the balloon comprises a strap for coupling the inlet cannula and the strap serves as a connector after dismantling the inlet cannula.

[0022] In some embodiments, the inferior layer is larger than the separation barrier to conform with the floor of the maxillary sinus.

[0023] In some embodiments, the inlet cannula is rigidly adapted to serve as a handle to maneuver the device through the lateral window into the maxillary sinus.

[0024] There is provided, in accordance with an embodiment, a device for sinus lift following a tearing of the Schneiderian membrane. The device comprises an elongated, biodegradable, multi-lumen balloon. The balloon comprises a first lumen which is fluid- or liquid-impermeable and is pre-shaped to form, when inflated, a horizontal cylinder segment. The first lumen may form a void between the floor of the maxillary sinus and the Schneiderian membrane of the maxillary sinus. The first lumen may create a seal between the void and a volume of the maxillary sinus which lies above the balloon. The balloon comprises a second lumen defined by a floor which is permeable to bone graft, to enable the bone graft to mesh with the bony floor of the maxillary sinus. The device comprises an inlet cannula in fluid communication with the first lumen of the balloon, to enable inflation of the first lumen. The device comprises one or more connectors attached to or integrally formed with the balloon, and adapted or configured to anchor the balloon medially to a rim of the preformed lateral opening in the maxillary sinus, to ensure the seal is maintained.

[0025] There is provided, in accordance with an embodiment, method for sinus lift following a tearing of the Schneiderian membrane. The method comprises an action of inserting a biodegradable membrane into a maxillary sinus, through a preformed lateral opening in the maxillary sinus. The method comprises an action of positioning the biodegradable membrane inside the maxillary sinus and below the Schneiderian membrane. The biodegradable membrane forms a void between the floor of the maxillary sinus and the Schneiderian membrane. The biodegradable membrane creates a seal between the void and a volume of the maxillary sinus which lies above the biodegradable membrane. The method comprises an action of filling at least some of the void with a bone graft.

[0026] In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the figures and by study of the following detailed description.

BRIEF DESCRIPTION OF THE FIGURES

[0027] Exemplary embodiments are illustrated in referenced figures. Dimensions of components and features shown in the figures are generally chosen for convenience and clarity of presentation and are not necessarily shown to scale. The figures are listed below.

[0028] FIG. 1 schematically shows a device and tool for sinus lift;

[0029] FIG. 2 schematically shows a device with inlet cannula for sinus lift; [0030] FIG. 3 schematically shows an inflated device for sinus lift;

[0031] FIG. 4 schematically shows a first lumen of a device for sinus lift inflated with saline;

[0032] FIG. 5 schematically shows a device for sinus lift inflated partially with saline and partially with bone graft material;

[0033] FIG. 6 schematically shows a second lumen of a device for sinus lift filled with bone graft material;

[0034] FIG. 7 shows three layers of an inflatable device for sinus lift;

[0035] FIG. 8 schematically shows welded layers of an inflatable device for sinus lift;

[0036] FIG. 9 schematically shows a 3D view of welded layers of an inflatable device for sinus lift;

[0037] FIG. 10 schematically shows perforations on an inferior layer of an inflatable device for sinus lift;

[0038] FIG. 11 schematically shows views of a single inlet inflatable device for sinus lift;

[0039] FIG. 12 schematically shows a cross section view of a single inlet inflatable device for sinus lift;

[0040] FIG. 13 schematically shows details of a first device for sinus lift;

[0041] FIG. 14 schematically shows details of a second device for sinus lift;

[0042] FIG. 15 schematically shows a first expanded shape of a device for sinus lift;

[0043] FIG. 16 schematically shows details of a fourth device for sinus lift;

[0044] FIG. 17 schematically shows a second expanded shape of a device for sinus lift;

[0045] FIG. 18 schematically shows details of a fifth device for sinus lift;

[0046] FIG. 19 schematically shows a third expanded shape of a device for sinus lift;

[0047] FIG. 20 schematically shows details of a sixth device for sinus lift;

[0048] FIG. 21 schematically shows details of a seventh device for sinus lift;

[0049] FIG. 22 schematically shows details of an eighth device for sinus lift;

[0050] FIG. 23 schematically shows details of a ninth device for sinus lift;

[0051] FIG. 24 schematically shows details of a tenth device for sinus lift;

[0052] FIG. 25 schematically shows details of an eleventh device for sinus lift; [0053] FIG. 26 schematically shows connecting protrusions for a device for sinus lift;

[0054] FIG. 27 schematically shows a lateral window in a maxillary bone for sinus lift;

[0055] FIG. 28 schematically shows a lateral window for sinus lift and the Schneiderian membrane;

[0056] FIG. 29 schematically shows a device and tool for sinus lift overlaid on a human head;

[0057] FIG. 30 schematically shows a first device for sinus lift overlaid on a human head and the Schneiderian membrane;

[0058] FIG. 31 schematically shows a second device for sinus lift overlaid on a human head and the Schneiderian membrane;

[0059] FIG. 32 schematically shows a device for sinus lift overlaid on a human head inflated with saline;

[0060] FIG. 33 schematically shows a device for sinus lift overlaid on a human head inflated with bone graft material;

[0061] FIG. 34 schematically shows a cross sectional view of a device for sinus lift inside a maxillary sinus;

[0062] FIG. 35 schematically shows a cross sectional view of a device for sinus lift inside a maxillary sinus and the Schneiderian membrane;

[0063] FIG. 36 schematically shows a cross sectional view of a device for sinus lift inside a maxillary sinus and the tool attached;

[0064] FIG. 37 schematically shows a balloon device for sinus lift inside a maxillary sinus and attached to a bone with connectors;

[0065] FIG. 38 schematically shows a separation barrier device for sinus lift inside a maxillary sinus and attached to a bone with inlet cannula attached;

[0066] FIG. 39 schematically shows a cushion device for sinus lift inside a maxillary sinus and attached to a bone with connectors;

[0067] FIG. 40 schematically shows a cushion device for sinus lift inside a maxillary sinus and filled with a bone graft material; and [0068] FIGs. 41A-41D show four stages of implanting a device for sinus lift inside a maxillary sinus.

DETAILED DESCRIPTION

[0069] Disclosed herein are aspects of embodiments of a device and method for overcoming a Schneiderian membrane tear during a sinus lift procedure. When a Schneiderian membrane tears during dental surgery, a device is inserted that comprises a separation barrier to separate the maxillary sinus into two compartments. The separation barrier is positioned within the maxillary sinus and attached to the maxillary bone to form the two compartments, which may herein be referred to as "superior compartment" and "inferior compartment". The separation barrier forms a barrier between the superior and the inferior compartment, such as a sealed barrier. The superior compartment contains the torn Schneiderian membrane, and the inferior compartment forms a void for inserting a bone graft material. Optionally, the upper surface of the separation barrier is smooth, to prevent friction with the Schneiderian membrane which might further damage it. The separation barrier allows the bone graft material to form a bone graft concurrently with the natural healing of the torn Schneiderian membrane. The surgeon may then insert a dental implant after the bone graft has formed, such as in a few months later.

[0070] Optionally, an implant is inserted before the bone graft material is inserted into the inferior compartment, and the bone graft forms around the implant. Optionally, the inferior compartment is filled with a quick hardening material that may later form a bone graft, allowing the insertion of an implant during the same patient visit.

[0071] The separation barrier and the forming of the two compartments allow the torn Schneiderian membrane to heal concurrently with bone graft generation, thereby saving patient time, pain, and suffering. Surgeon time is also saved. Typically, without using the present invention, when a Schneiderian membrane tears, the lateral window is closed by the surgeon and the patient is sent home to allow time for the Schneiderian membrane to heal before returning to the surgeon for the bone graft procedure. [0072] Optionally, the separating barrier is part of a balloon and inflating the balloon deploys the separating barrier into the maxillary sinus. For example, the balloon comprises a lumen that may be inflated with a bone graft fluid. For example, the balloon comprises two lumens, such as a multi-lumen balloon. The first lumen for inflating the balloon into the sinus by injecting a fluid, such as saline, air, and the like, into the first lumen, and the second lumen for inflating with a bone graft material, such as a fluid, thereby displacing the saline from the first lumen. Optionally, the fluid remains in the first lumen after the procedure. The inferior layer, such as forming the boundaries of the second lumen, adjacent to the maxillary bone may be permeable to the bone graft fluid, such as allowing the bone graft fluid to partially seep out of the inferior layer and connect with the maxillary bone, thus allowing vascularization of the bone graft and osseointegration. The seeping out of the bone graft material may be by pressure of the fluid bone graft material, a spatula pressing a solid/flake material, and/or the like. Optionally, a bone graft material is in the form of powder, flakes, granules, liquid, semi-liquid, slurry, any combination thereof, and/or the like.

[0073] Optionally, the device is a two-lumen balloon manufactured by welding together three layers: a separation barrier, a middle layer, and an inferior layer.

[0074] Optionally, the bone graft is made from powdered bone, powdered autologous bone, powdered bone substitute, and/or the like.

[0075] Optionally, the inferior layer of the balloon is perforated and/or perforations cover most of the layer in contact with the maxillary bone, to allow the bone graft to integrate with the maxillary bone. For example, the inferior layer comprises small holes to allow the formation of the bone graft. For example, the bottom layer is a net, mesh, or the like of a biodegradable material.

[0076] Optionally, the separating barrier forms a seal within the maxillary sinus. For example, the separation barrier is attached to the maxillary bone beneath the Schneiderian membrane with biodegradable glue. For example, the first lumen of the balloon is inflated with a biodegradable glue, and the first lumen comprises perforations on the edge of the separation barrier to allow the biodegradable glue to seep out of the first lumen along the edges of the separation barrier and seal the separation barrier to the maxillary bone thereby forming a void between the Schneiderian membrane and the floor of the maxillary sinus.

[0077] Optionally, the separation barrier comprises collagen on the side adjacent to the Schneiderian membrane.

[0078] Optionally, the separating barrier is thicker than the other layers of the device for better separation between the bone graft material and the maxillary sinus.

[0079] Optionally, the device comprises a collapsed configuration and an expanded configuration. The collapsed configuration may allow insertion through a lateral window of a maxillary sinus during a sinus lift. The expanded configuration may allow deployment of the separation barrier within the maxillary sinus and beneath a torn Schneiderian membrane. For example, the collapsed configuration is a folded shape, a rolled shape, crimped shape, and the like. Optionally the collapsed configuration means the device is folded, rolled, a combination of folded and rolled, and the like.

[0080] Optionally, the device comprises one or more connectors to attach the device to the maxillary bone near the lateral window of a sinus lift. The connector may be used to mechanically attach the separation barrier to the bone and hold it in place when filling the inferior compartment with the bone graft material. The connection may comprise straps, hooks, barbs, tacks, glue patches, screw holes, stapling areas, and/or the like, to allow attaching the connector to the bone and/or soft tissue.

[0081] Optionally, the device comprises a posterior layer rigidly coupled to the separation barrier, thereby supporting the separation barrier during filling of the void with a bone graft material, providing a seal between the two compartments, and/or the like. For example, the separation barrier and posterior layer are substantially perpendicular with a rigid or semi-rigid joint between them along the length of the device. The posterior layer may be inflatable separately or together with the separation barrier. [0082] Optionally, the inferior layer is larger in area than the separation barrier to conform to the maxillary sinus floor.

[0083] Optionally, the device comprises one or more braces for supporting the separation barrier. For example, the brace is connected between an edge of the separation barrier distal to the joint and between an edge of the posterior layer distal to the joint. For example, the brace is connected between edge of the separation barrier substantially perpendicular to the joint and between the edge of the posterior layer substantially perpendicular to the joint.

[0084] Reference is now made to FIG. 1, which shows a folded barrier device 101 and tool 102 for sinus lift. Device 101 may comprise a first lumen (not shown) for deploying device 101 within a sinus, the barrier separating the sinus into a first compartment and a second compartment. Device 101 may comprise a second lumen (not shown) for introducing a bone graft material into the second compartment. Device 101 may be first deployed by introducing a fluid into the first lumen through a first inlet 103 of tool 102. Bone graft material may be introduced into the second compartment through a second inlet 104 of tool 102. Device 101 and tool 102 may be separated after the insertion of the device into the maxillary sinus, such as before or after inflating and inserting the bone graft material into the created void. Examples described herein for specific figures may apply to other figures as well.

[0085] First inlet 103 may connect to device 101 through a cannula 103a, which may be used to inflate the device and may be detached after use. Second inlet 104 may connect to device 101 through a cannula 104a, for introduction of bone graft material. The device of FIG. 1 is shown in the collapsed state. For example, when deflated, the device has a maximal length of between 5-25 millimeters, and a maximal width of between 5-20 millimeters. This may allow easy insertion through the lateral window into the maxillary sinus. When inflated, the device has, for example, a maximal length of between 25-45 millimeters, a maximal width of between 15-35 millimeters. [0086] Reference is now made to FIG. 3 which shows device 101 for sinus lift, in its inflated state.

[0087] Reference is now made to FIG. 4 which shows a first lumen 401 of device 101 for sinus lift inflated with saline. The device may have barriers, such as a superior separation barrier 402, a middle barrier 403, and an inferior layer 404, that form a first lumen 401 for filling with a fluid, such as saline, thereby expanding the device within the maxillary sinus.

[0088] Reference is now made to FIG. 5 which shows first lumen 401 of device 101 inflated partially with fluid, such as saline. Also shown is lumen 501 partially inflated with bone graft material. As the bone graft material is inserted into the second lumen 501 the saline is displaced from the first lumen 401.

[0089] Reference is now made to FIG. 6 which shows second lumen 501 of device lOl.filled with bone graft material. First lumen 401 (not shown) is in deflated state.

[0090] Reference is now made to FIG. 7 which shows two layers of device 101 for sinus lift. A separation barrier 402 is superior to separation barrier 403 which is superior to inferior perforated barrier 404.

[0091] Reference is now made to FIG. 8 which shows welded layers of device 101 for sinus lift. By welding the layers the balloon is formed, which when inflated forms two lumens 401 and 501 (not shown).

[0092] Reference is now made to FIG. 9 which shows a 3D view of welded layers of device 101 for sinus lift. Optionally, the layers are attached together by other methods, such as glue, sutures, and the like. For example, the layers are fixed together with sutures and a fluid glue is used to inflate the first lumen, the glue seeps out of the edges of first lumen 401, and fixes/seals the superior separation barrier 402 to the maxillary bone (not shown). Shown also are the inlet cannulas 103a and 104a for inserting fluid into first lumen 401 (not shown) and a bone graft material into the second lumen 501 (not shown).

[0093] Reference is now made to FIG. 10 which shows perforations 1001 on a inferior barrier 404 of device 101. Perforations 1001 may be small holes with a diameter ranging for example from 0.1 to 1 millimeters, allowing the inferior barrier 404 to be permeable to a bone graft material to enable sufficient contact with the tissue and blood to mesh with the bony floor of the maxillary sinus. The second lumen (not shown) may be larger than the first lumen (not shown) to comply with the non-planar shape of the bony floor. Alternatively, the bone graft material may comprise granules (not shown) of mean diameter between, e.g., 0.4 to 2 millimeters such that the granules are larger than the perforations 1001 and may be retained with the second lumen (not shown), in such case the bone formation within the second lumen (not shown) relies on the entry of blood from the bony floor of the maxillary sinus.

[0094] Reference is now made to FIG. 11 which shows views of a single inlet device 1100 for sinus lift. The device may have an inlet cannula 1102. The device may comprise collagen on superior barrier 1103 adjacent to the Schneiderian membrane (not shown). The inferior barrier 1104, such as the barrier in contact with the maxillary bone, may be permeable to bone graft to enable sufficient contact with the bone tissue, allow vascularization, bone graft growth, and the like.

[0095] Reference is now made to FIG. 12 which shows a cross section view of a single inlet device 1200 for sinus lift, comprising a single lumen 1201.

[0096] Reference is now made to FIG. 13 which shows details of a first device 1400 for sinus lift. Device 1400 may comprise a superior barrier 1401, a permeable inferior barrier 1404, an inlet cannula 1402, and one or more connectors 1403. The device may be placed by inflating a first lumen 1405 through inlet cannula 1402. For example, the device creates a barrier from the torn Schneiderian membrane and at the same time a second lumen 1406 for the surgeon to fill with bone graft material using a spatula. First lumen 1405 is formed by superior barrier 1401 and a middle separation barrier 1407.

[0097] Reference is now made to FIG. 14 which shows details of a second device 1500 for sinus lift. Device 1500 may comprise one or more braces 1501 to support the middle separation barrier 1505, as in device 1400 of FIG. 13. Inflation of a first lumen 1502 positions superior barrier 1503 inferior to the torn Schneiderian membrane (not shown), and middle separation barrier 1505. Thus, first lumen 1502 is formed by superior barrier 1503 and a middle separation barrier 1505. Second lumen 1504 is formed by middle separation barrier 1505 and mesh 1506. Device 1500 may comprise an inlet cannula 1507 and one or more connectors 1508.

[0098] Reference is now made to FIG. 15 which illustrates a general shape of an expanded device 1600 for sinus lift according to present embodiments, such as a shape of an elongated brick with rounded corners 1601. For example, the device comprises a shape- memory (e.g., Nitinol) material, which is adapted or configured to assume a mesh-like structure. For example, when inflated, the device may have a maximal length of 15 to 45 millimeters, a maximal width of 10 to 30 millimeters, and a maximal height of 10 to 25 millimeters. When inflated, the device may have a maximal length of, for example, 5 to 70 millimeters, a maximal width of, for example, 5 to 45 millimeters, and a maximal height of, for example, 5 to 45 millimeters. For example, when deflated the device is small enough to be inserted through a lateral window, and when inflated the device should be big to separate the Schneiderian membrane from the bone graft (not shown).

[0099] Reference is now made to FIG. 16 which shows details of a fourth device 1700. For example, the device creates a barrier from the torn Schneiderian membrane and at the same time a volume for the surgeon to fill with bone graft material using a spatula for sinus lift. The fourth embodiment of a device may have an inflatable cushion type structure to increase the rigidity of the device when the first lumen 1702 is inflated. First lumen 1702 is formed by a superior barrier 1703 and a middle separation barrier 1706. The inflation of first lumen 1702 creates a second lumen 1705 with an optional perforated inferior barrier 1704 along the maxillary sinus floor. Device 1700 may comprise an inlet cannula 1707 and one or more connectors 1708.

[0100] Reference is now made to FIG. 17 which shows a second expanded shape of a device 1800 for sinus lift. For example, the device may assume the shape of an elongated brick and comprises a mesh made of, for example, shape-memory alloy such as Nitinol.

[0101] Reference is now made to FIG. 18 which shows details of a fifth device 1900 for sinus lift. For example, when deflated, device 1900 is small enough to be inserted through a lateral window, and when inflated, device 1900 is big enough to separate the Schneiderian membrane from the bone graft (not shown). The inferior barrier 1903 in contact with the maxillary bone may be a biodegradable material. To be absorbed within the time needed to begin formation the bone graft, such as the time needed for vascularization of the bone graft material for example, such as a few weeks. On the other hand, the superior barrier 1902 may be a biodegradable material that is dissolved only after the Schneiderian membrane is healed, such as after 1 to 4 months for example. Optionally, the inferior barrier 1903 is permeable and made of a non-biodegradable material, such as a Nitinol mesh. A first lumen 1901 is formed by superior barrier 1902 and a middle separation layer 1905. The inflation of first lumen 1901 creates a second lumen 1904 with inferior barrier 1903 along the maxillary sinus floor. Device 1900 may comprise an inlet cannula 1907 and one or more connectors 1906.

[0102] Reference is now made to FIG. 19 which shows a third expanded shape of a device 2000 for sinus lift. For example, the device has the shape of an elongated cylinder.

[0103] Following are further aspects of certain embodiments of a device for sinus lift.

[0104] Reference is now made to FIG. 20 which shows details of a sixth device 2100 for sinus lift. A first lumen 2101 is formed by a superior barrier 2102 and a middle separation barrier 2105. The inflation of the first lumen creates a second lumen 2104 with an inferior barrier 2103 along the maxillary sinus floor. Device 2100 may comprise one or more braces 2106 to support the middle separation barrier 2105.

[0105] Reference is now made to FIG. 21 which shows details of a seventh device 2200 for sinus lift. For example, balloon 2201 is shown without a permeable inferior barrier, such as an inflatable barrier for the Schneiderian Membrane. Device 2200 may comprise an inlet cannula 2202 and one or more connectors 2203.

[0106] Reference is now made to FIG. 22 which shows details of an eighth device 2300 for sinus lift. Device 2300 may have a biodegradable tubular body and one or more connectors. The tubular body may reside inside the sinus, beneath the torn membrane, and form a seal between the bone graft material inserted into the tube and the torn membrane.

[0107] Reference is now made to FIG. 23 which shows details of a ninth device 2400 for sinus lift. Device 2400 comprises an inferior barrier 2401, such as forming the boundary of the inferior lumen, adjacent to the maxillary bone. Inferior layer 2401 may be permeable to the bone graft material. Device 2400 is not inflatable. Rather, its superior layer expands as bone graft material is added into its inferior lumen. Device 2400 may comprise one or more connectors 2402.

[0108] Reference is now made to FIG. 24 which shows details of a tenth device 2500 for sinus lift. For example, as in other embodiments, but without a permeable inferior barrier, such as an inflatable barrier from the Schneiderian membrane. Device 2500 may comprise an inlet cannula 2501 and one or more connectors 2502.

[0109] Reference is now made to FIG. 25 which shows details of an eleventh device 2600 for sinus lift. For example, as in other embodiments, but without a permeable inferior layer, such as an inflatable barrier from the Schneiderian membrane. Device 2600 may comprise an inlet cannula 2601 and one or more connectors 2602.

[0110] Reference is now made to FIG. 26 which shows connecting protrusions 2701 and 2702 for a device for sinus lift. For example, the device has a connector with hooks, barbs, tacks, teeth, and the like, that attach to the tissue. Optionally, the connecting protrusions 2701 and 2702 are sutured to the soft tissue. Optionally, the connecting protrusions are attached to the maxillary bone using screws, staples, nails, and/or the like (not shown). One or both of these connecting protrusions may serve as the connectors discussed with reference to the previous figures.

[0111] Reference is now made to FIG. 27 which shows a lateral window 2801 in a maxillary bone 2802, wherein the window was created for sinus lift.

[0112] Reference is now made to FIG. 28 which shows a lateral window 2901 for sinus lift and the Schneiderian membrane 2902. A void 2903 exists between Schneiderian membrane 2902 and the maxillary sinus floor 2904. [0113] Reference is now made to FIG. 29 which shows a device 3001 and tool 3002 for sinus lift overlaid on a schematic illustration of a human skull. For example, the device is in its deflated state before insertion. Device 3001 may be any of the devices discussed with reference to the previous figures.

[0114] Reference is now made to FIG. 30 which shows a device 3101, which could be any of the aforementioned devices for sinus lift, overlaid on a human head. Also shown is a tool 3102 for inserting device 3101 into the sinus, and the Schneiderian membrane 3103

[0115] Reference is now made to FIG. 31 which shows a device 3201, which could be any of the aforementioned devices for sinus lift, overlaid on a human head. Also shown is a tool 3202 for inserting device 3101 into the sinus, and the Schneiderian membrane 3203.

[0116] Reference is now made to FIG. 32 which shows a lateral view a device 3300 for sinus lift, which could be similar to any of the aforementioned devices, overlaid on a human head and inflated with saline 3301.

[0117] Reference is now made to FIG. 33 which shows a device 3400 for sinus lift overlaid on a human head inflated with bone graft material 3401.

[0118] Reference is now made to FIG. 34 which shows a cross sectional view of a device 3500 for sinus lift inside a maxillary sinus 3501.

[0119] Reference is now made to FIG. 35 which shows a cross sectional view of an inflated device 3600 for sinus lift inside a maxillary sinus 3601 and the Schneiderian membrane 3602.

[0120] Reference is now made to FIG. 36 which shows a cross sectional view of a partially inflated device 3700 for sinus lift inside a maxillary sinus 3701 and the tool 3702 attached.

[0121] Reference is now made to FIG. 37 which shows an inflated balloon device 3800 for sinus lift inside a maxillary sinus 3801 and attached to a bone/tissue with connectors 3802.

[0122] Reference is now made to FIG. 38 which shows a separation barrier device 3900 for sinus lift inside a maxillary sinus 3901 and attached to a bone/tissue with connectors 3902. [0123] Reference is now made to FIG. 39 which shows a cushion device 4000 for sinus lift inside a maxillary sinus 4001 and attached to a bone with connectors 4002.

[0124] Reference is now made to FIG. 40 which shows a cushion device 4100 for sinus lift inside a maxillary sinus 4101 with a permeable inferior barrier 4102. Shown also are connectors 4103 used to attach device 4100 to the maxillary sinus bone 4104.

[0125] Reference is now made to FIGs. 41A-41D, which show a kit for implanting a sealed barrier 4200 in the maxillary sinus, in accordance with an embodiment. Barrier 4200 may be a biodegradable, flexible pocket. Barrier 4200, before implantation, may be collapsed over a balloon 4201, and the balloon further collapsed over an inflation tube 4203.

Inflation tube may be rigid or flexible. A syringe 4202, or any other fluid-filled container, may be releasably connected to tube 4203.

[0126] After a tear in the Schneiderian membrane 4205 is detected, barrier 4200 and balloon 4201 may be introduced into the maxillary sinus, beneath the tear, as schematically depicted by FIG. 41B. Syringe 4202 may then be operated to transfer the fluid (e.g., air, saline, etc.) it contains, through tube 4203, into balloon 4201. Balloon 4201 inflates, and, in turn, deploys barrier such the opening of its pocket structure overlies the lateral opening in the sinus, the superior part of the pocket structure lifts the torn Schneiderian membrane 4205, and its inferior side rests on the bony bottom of the sinus. Then, balloon 4201 may be emptied, such as by pulling the piston of syringe 4202 backwards, and the tube 4203 and balloon 4201 extracted from the sinus.

[0127] Bone graft material may then be inserted into barrier 4200. Before finalizing the procedures, the opening of the pocket structure of barrier 4200 may be secured to the edges of the opening in the sinus, such as by tacking or suturing.

[0128] Later, as barrier 4200 degrades, the bone graft material comes in contact with the bone at the bottom of the sinus, thus allowing vascularization of the bone graft and osseointegration.

[0129] The kit of FIGs. 41A-41D may alternatively be constructed and operated as follows: Instead of barrier 4200 being provided over balloon 4201, it may be provided separately. The surgeon may first manually insert barrier 4200 into the maxillary sinus through the lateral window, and secure its opening to the edges of the windows, for example by tacking or suturing. Barrier 4200 may be inserted while it is still collapsed or folded. Then, the surgeon may insert tube 4203 and balloon 4201 that overlies it into barrier 4200, and inflate the balloon by injecting fluid using syringe 4202. The inflation of balloon expands and deploys barrier 4200 inside the sinus, such that it fills a desired volume in the sinus, beneath the torn Schneiderian membrane 4205.

[0130] Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible sub-ranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0131] Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases "ranging/ranges between" a first indicate number and a second indicate number and "ranging/ranges from" a first indicate number "to" a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.

[0132] In the description and claims of the application, each of the words "comprise" "include" and "have", and forms thereof, are not necessarily limited to members in a list with which the words may be associated. In addition, where there are inconsistencies between this application and any document incorporated by reference, it is hereby intended that the present application controls.

Claims

CLAIMS What is claimed is:

1. A device for sinus lift following a tearing of the Schneiderian membrane, the device comprising:

(a) a multi-lumen balloon comprising:

a first lumen which is liquid-impermeable and is pre-shaped to form, when inflated, a separation barrier which extends along a length of the balloon, wherein the separation barrier:

(i) forms a void between a bony floor of a

maxillary sinus and the Schneiderian membrane of

the maxillary sinus, and

(ii) creates a seal between the void and a volume

of the maxillary sinus which lies above the balloon,

and

a second lumen defined by an inferior layer;

(b) an inlet cannula in fluid communication with the first lumen and configured to enable inflation of the first lumen; and

(c) at least one connector attached to the separation barrier, and configured to anchor the balloon medially to a rim of a preformed lateral opening in the maxillary sinus, to ensure that a seal is maintained by the separation barrier between the torn Schneiderian membrane and a bone graft.

2. The device according to claim 1, wherein the balloon is elongated, comprising a long dimension and at least one short dimension, wherein the long dimension defines a length of the balloon.

3. The device according to claim 1, wherein the inferior layer comprises perforations of diameter between 0.1 and 1 millimeters which is permeable to blood vessel formation, to enable a bone graft formed in the second lumen to mesh with the bony floor of the maxillary sinus, wherein the second lumen is larger than the first lumen to comply with the non-planar shape of the bony floor, wherein the bone graft comprises granules of mean diameter between 0.4 and 2 millimeters such that the granules are retained with the second lumen.

4. The device according to any one of the preceding claims, wherein the balloon is at least partially biodegradable.

5. The device according to any one of the preceding claims, wherein the first lumen further comprises a posterior layer which is substantially perpendicular to the separation barrier.

6. The device according to any one of the preceding claims, wherein the at least one connector is integrally formed with the balloon.

7. The device according to any one of the preceding claims, wherein the balloon is configured, when deflated, to be rolled or folded along the long dimension, to enable its compact insertion into the maxillary sinus through the preformed lateral opening.

8. The device according to any one of the preceding claims, wherein:

the rolling is a double rolling, formed by rolling two opposing ends of the balloon towards approximately a center of the long dimension of the balloon; and

the inlet cannula connects to the balloon at approximately the center of the long dimension.

9. The device according to any one of the preceding claims, wherein the balloon: when deflated, has a maximal length of between 25-45 millimeters, and a maximal width of between 15-35 millimeters; and

when inflated, has a maximal length of between 15-40 millimeters, and a maximal width of between 10-30 millimeters.

10. The device according any one of the preceding claims, wherein the balloon, when inflated, has a maximal height of between 10-25 millimeters.

11. The device according any one of the preceding claims, wherein the at least one connector comprises a plurality of straps each emerging from a different location of the balloon.

12. The device according to claim 11, wherein each of the straps comprises at least one of a tack and a hole disposed at an area of the at least one connector distal to the balloon.

13. The device according to any one of the preceding claims, wherein the at least one connector is at least partially of at least one of a biodegradable material and a biocompatible material.

14. The device according to any one of the preceding claims, wherein the second lumen is further defined by at least one of an anterior wall and a posterior wall which is permeable to bone graft, the walls form a corner of the void with the posterior layer and the separation barrier.

15. The device according to any one of the preceding claims, wherein the inlet cannula is adapted to be dismantled from the balloon

16. The device according to any one of the preceding claims, wherein the balloon comprises a strap for coupling the inlet cannula and the strap serves as a connector after dismantling the inlet cannula.

17. The device according to any one of the preceding claims, wherein the inferior layer is larger than the separation barrier to conform with the floor of the maxillary sinus.

18. The device according to any one of the preceding claims, wherein the inlet cannula is rigidly adapted to serve as a handle to maneuver the device through a lateral window into the maxillary sinus.

19. A device for sinus lift following a tearing of the Schneiderian membrane, the device comprising:

(a) an elongated, biodegradable, multi-lumen balloon comprising:

a first lumen which is liquid-impermeable and is pre-shaped to form, when inflated, a horizontally-oriented cylinder segment, so as to:

(i) form a void between the floor of the maxillary sinus and the Schneiderian membrane of the maxillary sinus, and

(ii) create a seal between the void and a volume of the maxillary sinus which lies above the balloon, and

a second lumen defined by a floor which is permeable to bone graft, to enable the bone graft to mesh with the bony floor of the maxillary sinus;

(b) an inlet cannula in fluid communication with the first lumen of the balloon, to enable inflation of the first lumen; and

(c) at least one connector attached to or integrally formed with the balloon, and configured to anchor the balloon medially to a rim of the preformed lateral opening in the maxillary sinus, to ensure the seal is maintained.

20. A method for sinus lift following a tearing of the Schneiderian membrane, the method comprising:

inserting a biodegradable membrane into a maxillary sinus, through a preformed lateral opening in the maxillary sinus;

positioning the biodegradable membrane inside the maxillary sinus and below the Schneiderian membrane, so as to: (a) form a void between the floor of the maxillary sinus and the

Schneiderian membrane, and

(b) create a seal between the void and a volume of the maxillary sinus which lies above the biodegradable membrane; and

filling at least some of the void with a bone graft.

21. The device according to any one of claims 1-19 for use in performing a sinus lift following a tearing of the Schneiderian membrane.

22. A kit for sinus lift following a tearing of the Schneiderian membrane, the kit comprising:

a tube;

a balloon disposed at a distal end of said tube, wherein the lumen of the balloon is in fluid communication with said tube; and

a biodegradable, flexible pocket structure disposed over said balloon.

23. A method for sinus lift following a tearing of the Schneiderian membrane, the method comprising:

inserting the balloon and the pocket structure of claim 22 into a maxillary sinus, through a lateral opening in the maxillary sinus, wherein the balloon is collapsed over said tube and the pocket structure is collapsed over said balloon;

injecting a fluid into the balloon through the tube, to inflate the balloon and expand the pocket structure in the maxillary sinus beneath a torn Schneiderian membrane;

aspirating the balloon, to collapse the balloon over the tube;

removing the balloon and the tube from the maxillary sinus; and

inserting bone graft material into the pocket structure.