GUIDED ENDODONTIC MICRO-SURGERY (EMS) WITH TREPHINE BURS
20190328486 ยท 2019-10-31
Assignee
Inventors
Cpc classification
A61C5/40
HUMAN NECESSITIES
A61B2034/108
HUMAN NECESSITIES
A61B2034/105
HUMAN NECESSITIES
A61C5/42
HUMAN NECESSITIES
A61B34/10
HUMAN NECESSITIES
A61B2034/107
HUMAN NECESSITIES
International classification
A61C5/42
HUMAN NECESSITIES
A61B34/10
HUMAN NECESSITIES
Abstract
Devices and methods for guided endodontic micro-surgery using trephine burs. The device includes a surgical guide comprising a dentate guard and a port extending from the dentate guard. The dentate guard is configured to conform to dentition of a patient proximate to a surgical site. The port has a bore extending therethrough such that a distal end of the bore terminates at the surgical site. The port, and its bore, are configured to receive a trephine bur for the EMS procedure at the surgical site.
Claims
1. A surgical guide for endodontic micro-surgery (EMS) comprising: a dentate guard configured to conformed to dentition of a patient proximate to a surgical site; and a port extending from the dentate guard and having a bore extending therethrough such that a distal end of the bore terminates at the surgical site, the port and bore configured to receive a trephine bur for the EMS procedure at the surgical site.
2. The surgical guide of claim 1, wherein the port is positioned and dimensioned with respect to the dentate guard so as to specify at least one of an angulation, a diameter of the trephine bur, and an osteotomy depth of the EMS procedure.
3. The surgical guide of claim 1, wherein a diameter of the bore ranges from about 2.0 mm to about 8.0 mm.
4. The surgical guide of claim 1, wherein a length of the port ranges from about 4 mm to about 20 mm.
5. The surgical guide of claim 1, wherein the dentate guard and the port are a unitary structure comprising resin, polyether, polyvinyl siloxane, vinyl polyether siloxane, or combinations thereof.
6. The surgical guide of claim 1, wherein a proximal end of the port defines a maximum osteotomy depth.
7. The surgical guide of claim 1, wherein the port includes a side window configured for visualization, irrigation, instrument insertion, or combinations thereof.
8. The surgical guide of claim 1, further comprising: a retractor extending from the dentate guard and configured to retract soft tissues from the surgical guide.
9. A method of performing a patient-specific endodontic micro-surgery (EMS) procedure, the method comprising: positioning the surgical guide of claim 1 on the dentition of a patient; and performing an osteotomy through the port.
10. The method of claim 9, wherein performing the osteotomy includes inserting a trephine bur through the port.
11. The method of claim 9, further comprising: resecting a root end of a tooth.
12. A method for single-step osteotomy, root-end resection, and biopsy of a tooth, the method comprising: positioning the surgical guide of claim 1 on the dentition of a patient; inserting a trephine bur through the port of the surgical guide; and advancing the trephine bur into the surgical site.
13. A surgical guide for endodontic micro-surgery (EMS) comprising: a dentate guard configured to conform to dentition of a patient proximate to a first surgical site and a second surgical site; a first port extending from the dentate guard and having a first bore extending therethrough such that a distal end of the first bore terminates at the first surgical site; and a second port extending from the dentate guard and having a second bore extending therethrough such that a distal end of the second bore terminates at the second surgical site, wherein each of the first and second ports and the respective first and second bores is configured to receive a trephine bur for the EMS procedure at the respective first and second surgical sites.
14. The surgical guide of claim 13, wherein each of the first and second ports is positioned and dimensioned with respect to the dentate guard so as to specify at least one of an angulation, a diameter of the trephine bur, and an osteotomy depth of the EMS procedure for the respective first and second surgical sites.
15. The surgical guide of claim 13, wherein a diameter of bore ranges from about 2.0 mm to about 8.0 mm.
16. The surgical guide of claim 13, wherein a length of each of the first and second ports independently ranges from about 4 mm to about 20 mm.
17. The surgical guide of claim 13, wherein the dentate guard and the first and second ports are a unitary structure comprising resin, polyether, polyvinyl siloxane, vinyl polyether siloxane, or combinations thereof.
18. The surgical guide of claim 13, wherein a proximal end of each of the first and second ports defines a maximum osteotomy depth for the respective first and second surgical sites.
19. The surgical guide of claim 13, wherein the first port, the second port, or both includes a side window configured for visualization, irrigation, instrument insertion, or combinations thereof.
20. The surgical guide of claim 13, further comprising: a retractor extending from the dentate guard and configured to retract soft tissues from the surgical guide.
21. The surgical guide of claim 13, wherein the first port is on a palatal side of the dentate guard and the second port is on a facial side of the dentate guard.
22-27. (canceled)
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
[0028] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present invention and, together with a general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention.
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[0061] It should be understood that the appended drawings are not necessarily to scale, presenting a somewhat simplified representation of various features illustrative of the basic principles of the invention. The specific design features of the sequence of operations as disclosed herein, including, for example, specific dimensions, orientations, locations, and shapes of various illustrated components, will be determined in part by the particular intended application and use environment. Certain features of the illustrated embodiments have been enlarged or distorted relative to others to facilitate visualization and clear understanding. In particular, thin features may be thickened, for example, for clarity or illustration.
DETAILED DESCRIPTION
[0062] Referring now to the figures, and in particular to
[0063] After evaluating images, impressions, models, or combinations thereof, surgical plan may be determined (Block 18), wherein such details may include location, angulation, depth, and so forth. If desired, suitable surgical planning materials (such as surgical planning software) may be used in determining details of the surgical plan and to development of a model of the surgical guide 12, which is described in greater detail below. The surgical plan may include developing a model for the surgical guide 12 to be fabricated and used in a surgical procedure. Fabrication of the surgical guide 12 may then follow (Block 20) and may include, for example, molding, 3D printing, or other conventional means of manufacturing using the materials described below. It is during the design process that all parameters of angulation and depth of osteotomy may be defined in view of the anatomy of the patient at the surgical site.
[0064] One exemplary embodiment may include the use of an 80 mm80 mm CBCT scan to produce a DICOM file from an impression of the dental arch; however, any scan volume from CBCT or conventional CT scan may be utilized for surgical guide design. The impression may also be subsequently scanned by a benchtop 3D scanner, producing an STL file which is uploaded along with the DICOM file from the CBCT into surgical guide planning software such as Mimics or Bluesky Bio.
[0065] With specific reference now to
[0066] The surgical guide 12 further includes a surgical port 26 having a bore 28 extending therethrough, wherein a distal end 30 of the port 26 aligns to a surgical site 32 for the patient. A diameter of the bore 28 may be configured to receive a trephine bur 34, an embodiment of which according to the present invention is shown in
[0067] The port 26 may be positioned and dimensioned, with respect to the dentate guard 22, so as to specify at least one of an angulation (with respect to a surface at the surgical site 32), a diameter, and a depth associated with the patient-specific EMS procedure at the surgical site 32. While not limiting, it may be advantageous, for example, for a length of the port 26 (illustrated as line l in
[0068] The surgical guide 12 may be constructed from a variety of materials, including, for example, any material that is sufficiently non-compliant so as to maintain a structure corresponding to the patient's dentition but yet is nonabrasive so as to not damage the patient's teeth. Such materials may include, for example, resin, polyether, polyvinyl siloxane, and vinyl polyether siloxane. For purposes of speed and simplicity, the surgical guide 12 may be fabricated by 3D printing, the filament for which may comprise any suitable, conventional material known to those of ordinary skill in the art having the benefit of the disclosure made herein.
[0069] With reference now to
[0070] The trephine bur 34 of
[0071] And so, with reference now to
[0072] The particular embodiment of the surgical guide 64 illustrated in
[0073] Referring now to
[0074] The particular embodiment of
[0075] Turning now to
[0076] The surgical guide 100 further includes a first surgical port 106 on a palatal side 108 of the surgical guide 100 and a second surgical port 110 on the facial side 112 of the surgical guide 100. Each port 106, 110 includes a bore 114, 116 extending therethrough such that distal ends (not shown in
[0077] Each port 114, 116 may be positioned and dimensioned, with respect to the dentate guard, so as to specify at least one of an angulation (with respect to a surface at the surgical sites), a diameter, and a depth associated with the patient-specific EMS procedure at the surgical site. Lengths of each port 114, 116 may also vary but is not required. The surgical guide 100 may be constructed from, and using methods, that were described in detail above.
[0078] In use, and referring again to
[0079] After optional soft tissue retraction, the surgical guide 12 may be positioned onto the dentition (UL1, UR1, UR2, UR3) of the patient and secured thereto by friction fit to the particular geometry and anatomy of the patient.
[0080] The trephine bur 34 may then be advanced into the port 26 so as to engage the surgical site 32. If desired, the bur edge 40 of the trephine port 34 may be pressed into the tissue at the surgical site 32 so as to create bleeding points to delineate a mucosal window. Optionally an incision may be made proximate to the bleeding points. The trephine bur 32 may be rotated, with or without sterile water irrigation, to incrementally cut through the bone, root end, soft tissue, and so forth. If a side windows 80 (
[0081] When the trephine osteotomy is complete, the trephine bur 32 may be retracted from the port 26 and the surgical guide 12 removed from the patient's teeth (UL1, UR1 UR2, UR3). If the cylindrical core of bone generated by the osteotomy remained in the surgical site 32, then the surgeon may remove the core as would be conventional. Otherwise, the core may be removed from within the barrel 38 of the trephine bur 34. The cylindrical core may include, in some instances, a root end, infected tissue, or combination thereof. One or more of these may be used for pathological assessment, if needed or desire. Additionally or alternatively, bone comprising the core may be used as an autogenous graft.
[0082] With the core removed, the resected root end and other structures within the surgical site 32 may be visualized. Certain tools may assist in visualization, such as a micro-mirror. The root end, surrounding bone, surgical site, and surrounding areas may be debrided and filled with a biocompatible material. Sutures may be used, in necessary, to close the surgical site 32 and/or any other incisions
[0083] The following examples illustrate particular properties and advantages of some of the embodiments of the present invention. Furthermore, these are examples of reduction to practice of the present invention and confirmation that the principles described in the present invention are therefore valid but should not be construed as in any way limiting the scope of the invention
EXAMPLES
Example 1Surgical Preparation and Planning
[0084] For cases presented herein, unless otherwise specified, an 80 mm80 mm preoperative cone beam computer tomography (CBCT) scan was carried out using a 3-D Accuitomo 170 (J Morita USA, Inc., Irvine, Calif.). Polyvinyl siloxane (PVS) impressions (Aquasil Ultra; Dentsply Caulk, Milford, Del.) were made and poured. To overcome restoration-associated artifacts, a digital 3D scan of the poured model, or in 1 case with minimally restored dentition, a CBCT scan of the PVS impression, was made and merged with the preoperative DICOM files. Care was taken to capture the alveolus at the surgical site during impression.
[0085] The cast was imaged by a 3 Shape D1000 benchtop scanner (Whip Mix Corp, Louisville, Ky.). The digital impression file was merged with the CBCT DICOM file in Mimics implant planning software (Materialise, Leuven, Belgium) or Blue Sky Plan 3 implant planning software (Blue Sky Bio, LLC, Grayslake, Ill.) for the design of the surgical guide.
[0086] Each surgical guide was designed with a port configured to accommodate a BIOMET 3i trephine bur (Palm Beach Gardens, Fla.) with the diameter, depth of penetration, angulation, and the site of root resection designed. Guide ports had a minimum depth of 7 mm to ensure trephine bur stabilization as determined during in vitro testing. The trephine bur diameter was selected based on root-end width, adjacent anatomic structures, and requirements for visualization. An irrigation window was created in the guide port to permit direct access for copious sterile saline for lubrication and cooling.
[0087] A stereolithography file of the surgical guide was produced and exported to a 3D printer (Objet 260 Connex3; Stratasys Ltd, Austin, Tex.). The 3D surgical guide was printed and an intimate fit verified with the poured cast.
[0088] After soft tissue reflection, the precise fit of the 3D surgical guide was verified. Two retractors cleared soft tissue from the surgical site. The trephine bur port provided protection to the soft tissue. A 5 mm or 6 mm outer-diameter hollow trephine bur was rotated at 1200 rpm with maximum torque in an electric hand piece (Anthogyr SAS, Sallanches, France) with sterile water irrigation, incrementally cutting through the bone, root end, and soft tissue with a light pecking motion over a period of time ranging from 1 minute to 2 minutes, depending on the depth of insertion.
[0089] After cutting, the trephine bur, the cylindrical core of bone, root end, and soft tissue were removed. The core specimen was submitted for biopsy.
[0090] Cases were completed under a surgical operating microscope (OPMI ProErgo; Zeiss Inc., Thornwood, N.Y.) to include ultrasonic root-end preparation and root-end filling with Endosequence BC Root Repair Material (Brasseler USA, Savannah, Ga.). Tissue was reapproximated and sutured.
[0091] For root-end resection of each case, respectively, adequate depth of penetration was designed and determined when the proximal extent of the trephine bur cylinder was flush with the orifice of the guide port (Example 2); a depth-defining washer was designed, printed, and placed over the shaft of the trephine bur such that the washer pressed against the guide port limiting penetration depth (Example 3); and the hand piece head touched the guide port (Example 4). Trephine burs with side venting, constant copious irrigation, and a gentle pecking motion allowed for osteotomy without excessive heat generation.
Example 2Maxillary Second Molar Palatal Root
[0092] A 66-year-old American Society of Anesthesiologists (ASA) class I woman taking no medications presented with biting pain in the posterior maxilla. Approximately 1 year before evaluation, tooth #1 was extracted, tooth #2 received nonsurgical root canal treatment, and tooth #3 received retreatment for a long-standing perforation and missed second mesiofacial canal. Tooth #3 had a 9 mm probing depth at the mesiolingual and a 6 mm probing depth at the distolingual. Two sinus tracts are identified in
[0093] For tooth #2, CBCT imaging revealed a 7 mm5 mm5 mm low density area at the apex of the palatal root with osseous healing at the mesiofacial and distofacial root ends compared with images from 1 year earlier. For tooth #3, CBCT imaging revealed an 8 mm8 mm6 mm low density area at the apex of the palatal root extending into the furcation, indicating failure of an attempted perforation repair with a hopeless prognosis. Tooth #2 diagnosis was previously treated with a chronic apical abscess, and the patient elected to have palatal root-end surgery in conjunction with extraction and ridge preservation of tooth #3.
[0094] The surgical site in this example was near the palatine artery, and surgery by traditional EMS would have been unacceptably risky. A surgical guide according to embodiments of the present invention with the port and bore configured to precisely direct a trephine bur to the surgical site (thus avoiding the palatine artery), permitted safe and effective EMS to be performed on this patient. Specifically, the port and bore were dimensioned so as to receive a 6 mm outer diameter trephine bur oriented to accommodate a palatal approach with clearance of the occlusal table on the contralateral side. Design of the surgical guide was such that the greater palatine artery was preserved, the palatal root was complete resected, and perforation of a pneumatized maxillary sinus between the facial and palatal roots was avoided.
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[0096] The surgical guide was positioned onto the patient, and the trephine bur was directed through the port and pressed against the mucosa to create bleeding points (
[0097] Root-end preparation and fill were accomplished. Bio-Oss (Geistlich Biomaterials, Princeton, N.J.) was placed in the osteotomy for tooth #2, and the palatal tissue was replaced and secured with 6-0 Monocryl Plus (Ethicon US LLC, Cornelia, Ga.). A freeze-dried bone allograft (Stryker, Kalamazoo, Mich.) with an Osseoguard membrane (BIOMET 3i) was placed and secured with 4-0 Monocryl sutures (Ethicon US LLC) at the extraction socket of tooth #3. Exemplary postoperative radiograph and photograph are shown in
[0098] At 2 weeks, all sutures were removed. The excised palatal tissue was replaced by new mucosa at 6 weeks. A biopsy report for tooth #2 described a periapical cyst. The patient remained asymptomatic throughout a 12 week follow-up period.
[0099] Sequential photographs of healing at 2 weeks, 4 weeks, and 3 months are shown in
[0100] The surgical guide ensured the greater palatine artery, which coursed near the surgical site, was preserved. The palatal tissue was replaced over the surgical site for patient comfort during anticipated healing by secondary intention. It is uncertain whether peripheral areas of the replanted tissue remained vital surrounding a central area of necrosis or if healing was completely by secondary intention.
Example 3Maxillary First Molar Fused DF-Palatal Root
[0101] A 39-year-old ASA class 1 woman taking no medications presented with left maxillary posterior biting pain of several months duration. A preoperative radiograph is shown in
[0102] This patient presented with a fused DF and palatal root (see
[0103] CBCT imaging and radiographic examination revealed root canal treatment of tooth #14 with 3 canals obturated with a 1 mm palatal root overfill and a 7 mm2 mm1 mm low density area associated with the apex of a fused DF and palatal root (
[0104] A PVS impression of the maxillary arch was made.
[0105] The surgery was performed under intravenous sedation. A full-thickness mucoperiosteal flap was elevated, and the surgical guide was inserted (
[0106] Retrograde fill of DF canal (blue arrow), palatal canal (black arrow), and a previously undebrided 6 mm isthmus was accomplished and are shown in the photograph of
[0107] Exemplary postoperative radiograph and photograph are shown in
[0108] The surgical guide enabled an accurate 11 mm osteotomy depth for resection of the fused DF palatal root.
Example 4Mandibular Second Premolar
[0109] A 23-year-old ASA class I man taking no medications presented with pain upon biting in the mandibular left posterior. Eleven years prior, tooth #20 received immediate apexification treating pulp necrosis associated with dens evaginatus. Teeth #s 18-21 all had probings less than 3 mm. Teeth #s 18, 19, and 21 were unrestored and had short cold responses, no percussion or palpation tenderness, and physiologic mobility. Tooth #20 had a porcelain crown with adequate margins, no cold response, moderate percussion tenderness, no palpation tenderness, and physiologic mobility.
[0110] Radiographic (
[0111] A PVS impression was imaged with a CBCT system, and resultant files were merged with preoperative CBCT imaging. The surgical guide was designed with the trephine port in a posture that would avoid trauma to the mental nerve.
[0112] The surgery was performed under oral sedation. A full-thickness mucoperiosteal flap was reflected without visualization of the mental nerve. Targeted EMS was performed. The surgical guide, once inserted, providing lip retraction (
[0113] Root-end inspection revealed serviceable white material consistent with tricalcium silicate cement, and no further root-end manipulation was conducted. Bone, root end, and soft tissue core prior to elevation are shown in
[0114] A biopsy report described a periapical granuloma.
[0115] At 1 week, the otherwise asymptomatic patient reported dysesthesia of the lower left lip to the midline for which he received a Medrol Dosepak (Pfizer, New York, N.Y.). At 1 month, the dysesthesia resolved, and the patient was asymptomatic. A two month postoperative photograph is shown in
[0116] The surgical guide ensured preservation of the mental nerve, which exited 2 mm apical to the trephine bur path.
[0117] According to embodiments of the present invention and as described herein, methods and surgical guides for successful surgical treatment in three anatomically challenging scenarios have been shown: (1) a palatal approach to the palatal root of a maxillary second molar, (2) a facial approach to a fused distofacial-palatal root of a maxillary first molar, and (3) a mandibular second premolar in close proximity to the mental foramen.
[0118] While the present invention has been illustrated by a description of one or more embodiments thereof and while these embodiments have been described in considerable detail, they are not intended to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The invention in its broader aspects is therefore not limited to the specific details, representative apparatus and method, and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the scope of the general inventive concept.