Abstract:
An internal sinus manipulation procedure for augmenting bone of a dental patient between the floor of the patient&#39;s sinus and a raised portion of the patient&#39;s sinus membrane comprising exposing a portion of the patient&#39;s sinus membrane immediately adjacent the floor of the patient&#39;s sinus followed by (i) a simultaneous and controlled lifting and lateral separation of the exposed portion of the sinus membrane from the sinus floor to form an open pocket between the sinus membrane and the sinus floor, (ii) introduction of a bone grafting material into the pocket and (iii) a compacting of the bone grafting material.

Description:
RELATED PATENT APPLICATION 
       [0001]    The present application claims the benefit of U.S. Provisional Patent application Ser. No. 60/882,940 filed Dec. 31, 2006, which is herein incorporated by reference. 
     
    
     BACKGROUND OF INVENTION 
       [0002]    The human posterior maxilla often presents dental clinicians with situations where there is a need to increase the available bone between the schneiderian (sinus) membrane and the floor of the maxillary antrum. For example, because of inadequate bone in the posterior maxilla of some dental patients, augmentation of the sinus floor is required before placement of a dental implant. 
         [0003]    An early sinus augmentation technique was presented by H. Tatum Jr. in 1977, later published in “Maxillary and Sinus Implant Reconstructions”, Dent Clin North Am 1986; 30(2):207-229 and first described by P. J. Boyne and R. A. James in 1980, “Grafting of the Maxillary Sinus Floor With Autogenous Marrow and Bone” J Oral Surg 1980; 38(8): 613-616. 
         [0004]    Originally Tatum accessed the maxillary sinus through the alveolar ridge crest using various instruments of his own design. Boyne and James later developed a lateral window technique modifying the known Caldwell-Luc procedure. In the Boyne and James technique, a horizontal incision was made in the posterior maxillary vestibule followed by exposure of the lateral osseous ridge wall of the posterior maxilla. An osteotomy window was then created by using burs in the lateral osseous ridge wall. The window of lateral wall was either removed or medially repositioned. The sinus membrane was gently released and reflected upward and an autogenous bone graft was then inserted over the exposed sinus floor. The flap was then replaced and primarily closed. A bladed-type implant was placed at 10-12 weeks following the augmentation procedure. 
         [0005]    These fundamental concepts have been retained in contemporary lateral window techniques such as described by C. E. Misch in “Maxillary Sinus Augmentation For Endosteal Implants: Organized Alternative Treatment Plans” Int J Oral Implant 1989: 4:49-58 and by J. N. Garg and C. R. Quinones in “Augmentation of the Maxillary Sinus. A Surgical Technique” Pract Periodontics Aesthet Dent 1997; 9:211-219. 
         [0006]    Implants are now often placed at the time of grafting according to the amount of pre-existing bone available for initial stability. However, post-operative complications such as pain or swelling due to extensive surgical trauma may increase patient discomfort. 
         [0007]    In 1994, Summers published a method for the sinus augmentation using an osteotome instrument, R. B. Summers “A New Concept In Maxillary Sinus. A surgical Technique” Compendium 1994: 15(2):152-158 and “The Osteotome Technique: Part 3-Less Invasive Methods Of Elevating The Sinus Floor” Compendium 1994: 15(6):698-704. In the Summers technique, after initial implant osteotomy drilling was performed, approximating the sinus floor, an osteotome was inserted to the osteotomy site and gently tapped fracturing and moving the sinus floor superiorly. The fractured sinus bone was pushed up, reflecting the Schneiderian membrane, and various bone graft materials were then added and implants immediately placed. 
         [0008]    Recently, modifications of the Summer&#39;s technique using spreading and condensing instrumentation and elevating the sinus using various pressure techniques have also been reported. Bori J E. “A new sinus lift procedure: SA-4/‘O’”. Dent Implantol Update 1991; 2(4):33-37; Smiler D G. “The sinus lift graft: basic technique and variations”. Pract Periodontics Aesthet Dent 1997; 9(8):885-893.9; Bruschi G B, Scipioni A, Calesini G, Bruschi E. “Localized management of sinus floor with simultaneous implant placement: a clinical report” Int J Oral Maxillofac Implants 1998; 13(2):219-226; M. Toffler “Site development in the posterior maxilla using osteocompression and apical alveolar displacement” Compend Contin Educ Dent 2001; 22(9):775-784; P. A. Fugazzotto, P. S. De “Sinus floor augmentation at the time of maxillary molar extraction: success and failure rates of 137 implants in function for up to 3 years”, J Periodontol 2002; 73(1):39-44; A. A. Winter A. S. Pollack, R. B Odrich “Placement of implants in the severely atrophic posterior maxilla using localized management of the sinus floor: a preliminary study”. Int J Oral Maxillofac Implants 2002; 17(5):687-695; M. Soltan, D. G. Smiler “Antral membrane balloon elevation”. J Oral Implantol 2005; 31(2):85-90; L. Chen, J. Cha “An 8-year retrospective study: 1,100 patients receiving 1,557 implants using the minimally invasive hydraulic sinus condensing technique”. J Periodontol 2005; 76(3):482-491. 
         [0009]    However, the amount of augmentation of the sinus floor and the volume of bone created is limited using the foregoing techniques and it is reportedly difficult in many cases to control the osteotome tapping force in order to produce effective membrane lifting without membrane perforation and on occasion the tapping procedure to fracture the sinus floor or to add bone graft material causes discomfort to the patient during the surgery. 
         [0010]    A new minimally invasive sinus augmentation technique is presented herein, called the “Internal Sinus Manipulation (ISM)” procedure, and is designed to facilitate sinus floor augmentation predictably while reducing treatment morbidity. 
       SUMMARY OF INVENTION 
       [0011]    The ISM internal sinus manipulation procedure augments bone of a dental patient between the floor of the patient&#39;s sinus and a raised portion of the patient&#39;s sinus membrane. Basically the ISM procedure comprises exposing a portion of the patient&#39;s sinus membrane immediately adjacent the floor of the patient&#39;s sinus followed by (i) a simultaneous and controlled lifting and lateral separation of the exposed portion of the sinus membrane from the sinus floor to form an open pocket between the sinus membrane and the sinus floor, (ii) introduction of a bone grafting material into the pocket and (iii) a compacting of the bone grafting material. 
         [0012]    The exposing of the portion of the sinus membrane should be without perforation of the sinus membrane and may be accomplished by the use of standard drills and drilling techniques and the like controlled to create an upward channel in the bone of the patient within the maxillary posterior area where the patient&#39;s existing bone is not sufficient. In this regard, the upper end of the channel should extend to the base of the sinus floor and should be small enough to only expose the portion of the sinus membrane that is to be lifted and laterally extended to form the pocket. 
         [0013]    The simultaneous lifting and lateral separation of the portion of sinus membrane from the sinus floor may be accomplished using a sinus lifting tool that includes a disk-shaped tip and an angled neck. The disk-shaped tip is designed to release the sinus membrane from the bony wall of sinus floor. The angled neck is designed to aid in the proper positioning of the working tip. An inflection portion of the angled neck extending from the working tip allows the clinician to feel the tension of the sinus membrane and to determine the amount of initial lateral and vertical membrane reflection. The procedure for membrane release and elevation should be continued until a planned amount of sinus extension is achieved and the pocket is defined. 
         [0014]    The packing of the bone grafting material may be accomplished with standard tapping burs or the like. Preferably however, prior to such tapping, a bone material condensing tool having longitudinally extending handle carrying at its distal end a laterally extending bone condensing head having a concave upper surface is employed to pre-condense the bone packing material upon a spinning of the handle of the tool on its longitudinal axis such that the condensing head produces a mixing and condensing of the bone packing material within the pocket. 
         [0015]    Also, in the ISM procedure, if the exposing of the portion of the sinus membrane leaves fragments of bone extending laterally into the channel adjacent the opening into the pocket, a bone breaking tool or instrument including a longitudinally extending handle having a laterally extending distal head with an inwardly and upwardly inclined lower surface may be employed to hook and break off such bone fragments leaving a clear opening into the pocket for the membrane lifting tool as illustrated in the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF ACCOMPANYING DRAWINGS 
         [0016]      FIG. 1  is a fragmentary sectional side view illustrating the step of exposing a portion of a sinus membrane as by employing a standard drill to form an upward channel through bone in the maxillary posterior area of a patent where the bone is of insufficient thickness to effectively receive a dental implant. 
           [0017]      FIG. 2  is a fragmentary sectional side view showing the bone channel of  FIG. 1  receiving a standard depth-measuring instrument for determining the depth of the bone surrounding the channel. 
           [0018]      FIG. 3  is a fragmentary sectional side view of the bone channel of  FIG. 1  receiving a sinus-lifting tool that includes a disk-shaped tip and an angled neck simultaneously lifting and laterally separating the exposed portion of the sinus membrane from the sinus floor to form a relatively small pocket between the sinus membrane and the sinus floor with lateral movement and a turning of the sinus lifting tool about a vertically extending axis of rotation. 
           [0019]      FIG. 4  is a fragmentary sectional side view of the bone channel of  FIG. 3  receiving a bone breaking tool or instrument including a longitudinally extending handle having a laterally extending distal head with an inwardly and upwardly inclined lower surface employed to hook and break off bone fragments extending into the upper open end of the channel leaving a clear opening into the pocket for the membrane lifting tool as illustrated in  FIG. 5 . 
           [0020]      FIG. 5  is a fragmentary sectional side view of the bone channel of  FIG. 4  again receiving the sinus-lifting tool of  FIG. 3  to simultaneously further lift and laterally separate the exposed portion of the sinus membrane from the sinus floor to enlarge the pocket between the sinus membrane and the sinus floor with lateral movement and a turning of the sinus lifting tool about a vertically extending axis of rotation as shown in  FIG. 3 . 
           [0021]      FIG. 6  is a fragmentary sectional side view of the channel and pocket of  FIG. 5  illustrating the introduction of bone grafting material into the enlarged pocket using a graft material insertion tool, the graft material in the pocket slightly enlarging the pocket to a relatively smooth dome shape. 
           [0022]      FIG. 7  is a fragmentary sectional side view of the channel and pocket of  FIG. 6  illustrating a bone material condensing tool having a longitudinally extending handle carrying at its distal end a laterally extending bone condensing head having a concave upper surface employed to pre-condense the bone packing material upon a spinning of the handle of the tool on its longitudinal axis such that the condensing head produces a mixing and condensing of the bone packing material within the pocket. 
           [0023]      FIG. 8  is a fragmentary sectional side view of the channel and the bone graft material filled pocket of  FIG. 7  including a standard tapping bur for further condensing the bone graft material. 
           [0024]      FIG. 9  is a fragmentary sectional side view of the channel and the condensed bone graft material of  FIG. 8  including a dental implant recurred in the bone and condensed bone graft material. 
       
    
    
     DETAILED DESCRIPTION OF INVENTION 
       [0025]    In practice, prior to beginning the ISM procedure generally described above, a patient treatment plan should be established based on clinical evaluation, diagnostic wax-up on a study cast and radiographic information from a periapical radiograph, a panoramic radiograph or a computerized tomogram. Then, after full thickness flap elevation or through a flapless procedure, a standard implant osteotomy drilling sequence is followed using a surgical guide, a round marker and subsequent twist drills. Such a drilling procedure is depicted in  FIG. 1  where a standard twist drill  10  is shown forming a channel  12  in the bone  14  of in the maxillary posterior area of a patent where the bone is of insufficient thickness to effectively receive of a dental implant. As previously indicated, conventional twist drills or surgical round diamond burs can be used to drill up to the sinus floor  16 , barely breaking through the existing bone, without perforating the sinus membrane  18 , to expose through an upper open end  13  of the channel  12 , the portion  20  of the sinus membrane that is to be lifted and laterally separated from the sinus floor  16  in the ISM procedure. 
         [0026]    Following the formation of the bone channel  12  as depicted in  FIG. 1  and as shown in  FIG. 2 , a conventional depth gauge instrument  22  having axially spaced measuring marks and a blunt tip  23  may be employed to measure the thickness of the bone  14  in the channel  12 , check the integrity of membrane  18 , particularly of portion  20 , and to verify the amount of the membrane lifting previously determined in the development of the patient treatment plan. 
         [0027]    Next, as illustrated in  FIG. 3 , the portion  20  of the sinus membrane  18  is simultaneously lifted and laterally separated from the sinus floor  16  to form a small downwardly open pocket  24  between the vertically lifted portion  20  of the sinus membrane  18  and the sinus floor  16 . Preferably, such simultaneous lifting and lateral separation is accomplished by the use of a sinus lifting tool  26  that includes a disk-shaped tip  28  and an angled neck  30  extending longitudinally from a handle portion  32 . The disk-shaped tip  28  is designed to release the sinus membrane  18  from the bony wall of sinus floor  16 . The angled neck  30  is designed to aid in the proper positioning of the working tip  28 . An inflection portion  31  of the angle of the neck  30  extending from the working tip  28  allows the clinician to feel the tension of the sinus membrane  18  and to determine the amount of initial lateral and vertical membrane reflection. As illustrated in  FIG. 3  by the solid, dashed and broken line outlines of the tool  26 , in the formation of the pocket  24  the tool  26  is simultaneously raised and turned back and forth on vertically extending axis  34  with the tip  28  simultaneously lifting and laterally separating the membrane  20  from the sinus floor  16  to form and enlarge the pocket  24 . This procedure of simultaneous membrane lateral release and elevation is continued until a planned amount of sinus extension is achieved and the small open pocket  24  is defined. A preferred form of the tool  26  is described and illustrated more fully in the concurrently filed U.S. patent application Ser. No. ______, entitled “Improved Sinus Membrane Lifting and Lateral Separation Instrument” (Docket 07JY-3), incorporated herein by this reference. 
         [0028]    As illustrated in  FIGS. 1-4 , in the formation of the channel  12 , small inwardly directed bone fragments  15  may surround or extend into the small opening  13  in the channel  12 . As illustrated in  FIG. 4 , after the formation of the small pocket  24  as shown in  FIG. 3 , such bone fragments  15  are removed. Preferably such bone fragment removal is accomplished using a bone breaking tool or instrument  36  including a longitudinally extending handle  38  having a laterally extending distal head  40  with an inwardly and upwardly inclined lower surface  42 . As illustrated, the lower surface  42  is employed to hook the bone fragments  15  and with a downward pulling on the handle  38  to break off the bone fragments  15  extending into the upper open end  13  of the channel  12  leaving a clear opening into the pocket  24  for the membrane lifting tool  26  as illustrated in  FIG. 5 . A preferred form of the tool  36  is described and illustrated more fully in the concurrently filed U.S. patent application Ser. No. ______, entitled “Improved Bone Breaking Instrument” (Docket 07JY-2), incorporated herein by this reference. 
         [0029]    While not specifically shown, if it is desired to further refine the open end  13  or inner wall of the channel before proceeding further with the ISM procedure, the channel  12  may be widened, for example, to the appropriate width of any subsequently planned implant placement utilizing the same length of stopping cylinder twist drills or standard implant twist drills as depicted in  FIG. 1 . 
         [0030]    As shown in  FIG. 5 , following the removal of the inwardly directed fragments from the channel  12  as shown in  FIG. 4  or the above mentioned widening of the channel  12 , the previously described sinus-lifting tool  26  of  FIG. 3  is again inserted into the bone channel  12  to simultaneously further lift and laterally separate the exposed portion  20  of the sinus membrane  18  from the sinus floor  16  to enlarge the pocket  24  between the sinus membrane  18  and the sinus floor with a turning of the sinus lifting tool about a vertically extending axis of rotation as shown in  FIG. 3 . 
         [0031]    Next, as depicted in  FIG. 6 , an appropriate standard bone grafting material  44  is introduced into the enlarged pocket  24  using a graft material insertion tool  46  designed to carry the material upward in the channel and into the pocket, the graft material in the pocket slightly enlarging the pocket to a relatively smooth dome shape. 
         [0032]    The bone graft material  44  in the enlarged pocket  24  shown in  FIG. 7  is then condensed by a bone material condensing tool  48  having longitudinally extending handle  50  carrying at its distal end a laterally extending bone condensing head  52  having a concave upper surface  54  employed to pre-condense the bone packing material upon a spinning of the handle  50  of the tool on its longitudinal axis and lateral movement (depicted by the dashed outlines) of the tool such that the condensing head produces a mixing and condensing of the bone packing material within the pocket  24 . A preferred form of the tool  48  is described and illustrated more fully in the concurrently filed U.S. patent application Ser. No. ______, entitled “Improved Bone Graft Material Packing Instrument” (Docket 07JY-4), incorporated herein by this reference. 
         [0033]    At the final stage of bone grafting, a conventional tapping bur  56  can be used to pack and push up additional bone graft material  44  into the pocket  24  (or osteotomy socket) as depicted in  FIG. 8 . A conventional depth gauge instrument (not shown) can be used to check the height of the vertical augmentation of the membrane portion  20  while packing the bone material. 
         [0034]    After completion of the bone grafting, a conventional dental implant can be placed in the bone channel  12  and the packed bone graft material  44  in the pocket  24  in a conventional manner as depicted in  FIG. 9 . 
         [0035]    While particular embodiments of the method and the preferred instruments employed in the method have been illustrated and described in detail above, it is appreciated that changes and modifications may be made in the illustrated embodiments without departing from the spirit of the invention. Accordingly, the scope of present invention is to be limited only by the terms of the following claims.