Guiding Device for Dental Anesthesia
20170028143 ยท 2017-02-02
Inventors
Cpc classification
A61M5/3287
HUMAN NECESSITIES
International classification
A61M5/32
HUMAN NECESSITIES
Abstract
The invention provides a device for the practice of oral medicine, including dentistry. Specifically, the invention relates to a guiding device that helps to prevent injecting beyond the pterygomandibular space during inferior alveolar nerve block for which purpose the injection is administered in the vicinity of the inferior alveolar nerve. The device has a retro-mandibular tip (12) operably linked to a guide tube (14) by a connecting unit (20, 22, 24), the guide tube (14) is adapted to receive a syringe and has a stopper mechanism (19) to stop the advancement of the syringe such that its needle is located at a predetermined distance from the posterior edge of the mandibular ramus.
Claims
1. A device for administering an injection of anesthesia in the vicinity of an inferior alveolar nerve, in a subject, the device comprising: a retro-mandibular tip operably linked to a guide tube, said guide tube adopted to receive a syringe, wherein said guide tube comprises a stopper mechanism adopted to stop the advancement of said syringe, passing through said guide tube, at a predetermined point in said syringe.
2. The device of claim 1, wherein said stopper mechanism is adopted to stop the advancement of said syringe when its needle is located at a distance, ranging between about 7 mm and about 25 mm, from the posterior edge of the mandibular ramus.
3. The device of claim 1, wherein said stopper mechanism is adopted to stop the advancement of said syringe when its needle is located at a distance, ranging between about 7 mm and about 14 mm, from the posterior edge of the mandibular ramus.
4. The device of claim 1, wherein said stopper mechanism is adopted to stop the advancement of said syringe when its needle is located at a distance of about 15 mm from the posterior edge of the mandibular ramus.
5. The device of claim 1, wherein said guide tube comprises an inlet port and an outlet port and wherein the stopper mechanism is adopted to stop the advancement of said syringe such that the distance between the edge of the inlet port and the retro-mandibular tip edge (ER) equals the sum of the distance between the edge of the inlet port and the point of needle (EP) and the distance between and the point of needle and the retro-mandibular tip edge (PR).
6. The device of claim 5, wherein the stopper mechanism is adopted to stop the advancement of said syringe, in accordance with the following relationship:
ER=EP+PR, wherein ER refers to the distance between the edge of the inlet port and the retro-mandibular tip edge, EP refers to the distance between the edge of the inlet port and the point of needle, and PR refers to the distance between and the point of needle and the retro-mandibular tip edge.
7. The device of claim 5, wherein the position of said guide tube also reflects the length of the needle (PF) and the length of a portion of the syringe body (FC).
8. The device of claim 5, wherein the outlet port of said guide tube has a reduced diameter relative to the diameter of inlet port such that the guide tube abuts against the end of the syringe body.
9. The device of claim 1, wherein said guide tube comprises an inlet port and an outlet port and wherein the stopper mechanism is adopted to stop the advancement of said syringe such that the distance between the edge of the outlet port and the retro-mandibular tip edge (SR) equals the sum of the needle length (PF) and the distance between and the point of needle and the retro-mandibular tip edge (PR).
10. The device of claim 9, wherein the stopper mechanism is adopted to stop the advancement of said syringe, in accordance with the following relationship:
SR=PF+PR, wherein SR refers to the distance between the edge of the outlet port and the retro-mandibular tip edge, PF refers to the needle length, and PR refers to the distance between and the point of needle and the retro-mandibular tip edge, and wherein said PR ranges from about 7 mm to about 25 mm.
11. The device of claim 1, wherein said device further comprises a connecting unit that operably links said retro-mandibular tip to said guide tube.
12. The device of claim 1, wherein said connecting unit comprises one or more connecting arms.
13. The device of claim 12, wherein said connecting unit comprises a first, a second, and a third connecting arm, wherein said first connecting arm operably links said retro-mandibular tip to said second connecting arm, said second connecting arm operably links said first connecting arm to said third connecting arm, and said third connecting arm operably links said second connecting to said guide tube.
14. The device of claim 13, wherein the orientation of guide tube and retro-mandibular tip are positioned such that the angle between the axis of guide tube orientation and the straight axis parallel to said second connecting arm is about 21.
15. The device of claim 1, wherein said device is made of material selected from the group consisting of polymers, plastics, thermoplastics, metals, alloys and combinations thereof.
16. The device of claim 1, wherein said device comprises polymer.
17. The device of claim 1, wherein said subject is a human subject.
18. A guiding device for administering an injection of anesthesia in the vicinity of an inferior alveolar nerve, in a subject, the device comprising: a retro-mandibular tip operably linked to a guide unit, said guide unit adopted to receive a syringe, wherein said guide unit comprises a mechanism adopted to hold said syringe such that its needle is located at a distance, ranging between about 7 mm and about 25 mm, from the posterior edge of the mandibular ramus.
19. A method of administering an injection of anesthesia in the vicinity of an inferior alveolar nerve of a subject, the method comprising the steps of: a) providing the device of claim 1; b) holding said device in place in contact with a facial region relating to a mandible; c) inserting a syringe through said guide tube; and d) administering the injectable medium at a location immediately before the inferior alveolar enters the mandibular foramen.
20. A method of administering an injection of anesthesia in the vicinity of an inferior alveolar nerve of a subject, the method comprising the steps of: a) providing the device of claim 17; b) holding said device in place in contact with a facial region relating to a mandible; c) inserting a syringe through said guide tube; and d) administering the injectable medium at a location immediately before the inferior alveolar enters the mandibular foramen.
21. A device for administering an injection of anesthesia in the vicinity of an inferior alveolar nerve, in a subject, the device comprising: a retro-mandibular tip operably linked to a guide tube by a connecting unit, said guide tube adopted to receive a syringe, wherein said guide tube comprises a stopper mechanism adopted to stop the advancement of said syringe, passing through said guide tube, at a predetermined point in said syringe, and wherein said stopper mechanism is adopted to stop the advancement of said syringe when its needle is located at a distance, ranging between about 7 mm and about 25 mm, from the posterior edge of the mandibular ramus.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0012]
[0013]
[0014]
[0015]
[0016]
[0017]
[0018]
[0019]
DETAILED DESCRIPTION OF THE INVENTION
[0020] The invention provides a guiding device for administering an injection of anesthesia in the vicinity of an inferior alveolar nerve. Specifically, the invention provides a guiding device that helps to prevent injecting beyond the pterygomandibular space during inferior alveolar nerve block.
[0021] In one embodiment, provided herein is a guiding device for administering an injection of anesthesia in the vicinity of an inferior alveolar nerve, in a subject, the device comprising: a retro-mandibular tip operably linked to a guide unit, said guide unit adopted to receive a syringe, wherein said guide unit comprises a mechanism adopted to hold said syringe such that its needle is located at a predetermined distance from the posterior edge of the mandibular ramus.
[0022] In another embodiment, provided herein is a guiding device for administering an injection of anesthesia in the vicinity of an inferior alveolar nerve, in a subject, the device comprising: a retro-mandibular tip operably linked to a guide tube, said guide tube adopted to receive a syringe, wherein said guide tube comprises a stopper mechanism adopted to stop the advancement of said syringe, passing through said guide tube, at a predetermined point in said syringe.
[0023] In another embodiment, provided herein is a method of administering an injection of anesthesia in the vicinity of an inferior alveolar nerve of a subject, the method comprising the steps of: a) providing a guiding device, the device comprising a retro-mandibular tip operably linked to a guide unit, said guide unit adopted to receive a syringe, wherein said guide unit comprises a mechanism adopted to hold said syringe such that its needle is located at a predetermined distance from the posterior edge of the mandibular ramus; b) holding said device in place in contact with a facial region relating to a mandible; c) inserting a syringe through said guide tube; and d) administering the injectable medium at a location immediately before the inferior alveolar enters the mandibular foramen.
[0024] In another embodiment, provided herein is a method of administering an injection of anesthesia in the vicinity of an inferior alveolar nerve of a subject, the method comprising the steps of: a) providing a guiding device, the device comprising a retro-mandibular tip operably linked to a guide tube, said guide tube adopted to receive a syringe, wherein said guide tube comprises a stopper mechanism adopted to stop the advancement of said syringe, passing through said guide tube, at a predetermined point in said syringe; b) holding said device in place in contact with a facial region relating to a mandible; c) inserting a syringe through said guide tube; and d) administering the injectable medium at a location immediately before the inferior alveolar enters the mandibular foramen.
[0025] Human mandible and inferior alveolar nerve block are fully described in U.S. Pat. Nos. 6,139,529 and 8,257,341; U.S. Patent Application Publication 20110236866; and PCT International Patent Application Publication WO2010/097520, all of which are incorporated herein in their entirety.
[0026]
[0027] Mandibular foramen 5 on the internal surface of ramus 2 provides an ideal location for administering anesthesia to a patient. Generally, the anesthesia is administered near the mandible foramen 5 to cause blockage of the nerve and the nearby lingual nerve for subsequent dental procedures.
[0028] However, this process has proven difficult because of the existence of soft tissue as well as small space to work, combined with various anatomical variations. As discussed above, for guide devices used in existing syringe, the tip of the needle comes into abutment against the medial side of the ramus 2. Upon its penetration into the soft tissue, the needle may bend, deflect, or slide along the pterygomandibular fascia thereby changing the trajectory imposed by the device. The tip can then be found beyond the pterygomandibular space (in parotid space), resulting in a temporary paralysis of the facial nerve.
[0029] The inventor of the instant patent application developed a device that overcomes the aforementioned problems. Specifically, the inventor of the instant application developed a guiding device that helps to prevent injecting beyond the pterygomandibular space during inferior alveolar nerve block.
[0030] As shown in
[0031] Guide tube 14 is adopted to receive and hold a syringe 30, as shown in
[0032] In a particular embodiment, guide tube 14 includes mechanism adopted to hold syringe 30 such that, during dental anesthesia, its needle 34 is located at a predetermined distance, for example, ranging between about 7 mm and about 25 mm, from the posterior edge of the mandibular ramus 2. In one example, the mechanism is a stopper mechanism 19 adopted to stop the advancement of said syringe 30, passing through said guide tube 14, at a predetermined point in syringe 30. In some embodiments, outlet port 18 has a reduced diameter relative to the diameter of inlet port 16 such that the guide tube 14 abuts against the end of the syringe body 32.
[0033] Any stop or lock mechanism, known to one of skilled in the art, capable of stopping the advancement of syringe 30 passing through said guide tube 14 can be used. Examples of such mechanisms, include, but are not limited to hinge and knob.
[0034] Stopper mechanism 19 holds syringe 30 or stops advancement of syringe 30 at a predetermined point such that its needle 34 is located at a predetermined distance from the posterior edge of the mandibular ramus 2. The predetermined distance may range between about 7 mm and about 25 mm, preferably 15 mm. In a particular embodiment, the predetermined distance is about 15 mm. In some embodiments, the predetermined distance may range between about 7 mm and about 15 mm, and preferably between about 9 mm and 12 mm.
[0035] Retro-mandibular tip 12 is operably linked to guide tube 14 by any suitable connecting mechanisms known to one of skilled in the art. In some embodiments, connecting mechanism includes one or more connecting arms (e.g., items 20, 22, and 24 shown in
[0036] In some embodiments, as shown in
[0037] In one embodiment, as shown in
ER=EP+PR,
wherein ER refers to the distance between the edge of the inlet port 16 and the retro-mandibular tip 12 edge, EP refers to the distance between the edge of the inlet port 16 and the point of needle 34, and PR refers to the distance between and the point of needle 34 and the retro-mandibular tip 12 edge.
[0038] As shown in
[0039] In some embodiments, as shown in
[0040] In one embodiment, as shown in
SR=PF+PR,
wherein SR refers to the distance between the edge of the outlet port 18 and the retro-mandibular tip 12 edge, PF refers to the needle 34 length, and PR refers to the distance between and the point of needle 34 and the retro-mandibular tip 12 edge, and wherein said PR ranges, for example, from about 7 mm to about 25 mm.
[0041] As shown in
[0042] Guiding device 10 can be made of any suitable material, known to one of skilled in the art. Examples of such materials include, but are not limited to, polymers, plastics, thermoplastics, metals, alloys and combinations thereof. In a particular embodiment, guiding device 10 is made of a polymer.
[0043] The invention also provides methods for administering an injection of anesthesia in the vicinity of an inferior alveolar nerve of a subject. As shown in
[0044] The guiding device 10 of the invention can also be used in conjunction with one or more complementary injection techniques, such as, for example, but not limited to, the Gow-Gates mandibular nerve block, Akinosi-Vazirani closed-mouth mandibular nerve block, intra-osseous anesthetic injection, periodontal ligament anesthetic injection, and retromolar technique.
[0045] The term subject, as used herein, may refer to both human and non-human subjects.
[0046] Any patent or patent application publication cited herein is incorporated by reference herein in its entirety.
[0047] The following examples are presented in order to more fully illustrate the preferred embodiments of the invention. They should in no way be construed, however, as limiting the broad scope of the invention.
EXAMPLES
Example 1
Design of a Guiding Device for Inferior Alveolar Nerve Block
[0048] The availability of several techniques for inferior alveolar nerve analgesia in a targeted area of the pterygomandibular space reflects the difficulties faced by practitioners. The objective of this study was to design a guiding device for inferior alveolar nerve block. An analysis of 40 CT scans of facial masses aided in the determination of the most appropriate configuration of the guiding device. Depending on individual morphological characteristics, the projection point of the device was situated on the medial surface of the mandibular ramus, between 7.0 mm and 14.0 mm anterior to the posterior edge of the ramus.
Materials and Methods
Materials
[0049] The design of the device was conducted with CT scans made in the Medical Imaging Service at the Hospital of Troyes (France), on 40 consecutive patients aged 12 to 71 years (21 men, 19 women) with no exclusion criteria. These patients had undergone one of the following interventions: extraction of impacted third molars near the inferior alveolar nerve, treatment of impacted canines, pre-implant assessment, or excision of a cyst close to the inferior alveolar nerve.
[0050] The tomodensitometric sections were obtained with the aid of a Toshiba AQUILON 64 scanner (Nasu, Japan) with the following parameters: section thickness, 0.5 mm; pitch, 1.0 mm; and field size, 30.0 mm. The axial cuts studied (scale 1:1) were slices that passed the mandibular ramus, parallel to the inferior border of the body of the bone.
Method
[0051] For Inferior Alveolar Nerve Block (IANB) to be successful, the tip of the needle must be in contact with the medial surface of the mandibular ramus, above and behind the lingula of the mandible, which marks the anterior edge of the mandibular foramen. This site favors the diffusion of the solution toward the foramen.
[0052] A projection plane precisely defined the orientation of the syringe at the moment of injection. This projection plane is passed by two axes (
[0053] The first axis was situated at the medial surface of the mandibular ramus, 14.0 mm anterior to its posterior edge. This axis was determined in such a way that it was always situated behind the lingula of the mandible and considered individual variations in the position of the lingula. Previously, it was reported that the position of the lingula can vary from one mandible to another by a distance of 14.0-23.0 mm anterior to the posterior edge of the mandibular ramus.
[0054] The second axis passed by the mesiobuccal cusp of the first mandibular molar opposite the side designated for analgesia, and by the contact point between the second premolar and the first maxillary molar opposite the side designated for analgesia. This axis was determined so that it would be situated sufficiently laterally in the oral cavity to avoid an anatomical obstacle: the temporal crest.
[0055] The orientation of the body of the syringe in the projection plane and according to the highest axis in the oral cavity is compatible with successful analgesia. Because the projection plane cannot be visualized in the mouth, this study was undertaken with axial CT sections.
[0056] The projection angle between the projection plane and the sagittal plane passing by the posterior edge of the mandibular ramus varies among individuals and depends on the shape of the dental arches and the orientation of the mandibular ramus. To evaluate the amount of variation in this projection angle, the inventor selected three reference points on each tomodensitometric section (
[0057] Two axes corresponded to these three points, the ramus axis (R, P) and the projection axis (P, D). These axes formed two respective angles with the sagittal plane passing by point R: the ramus angle and the projection angle, which inspired the design of the guiding device.
[0058] As shown in
[0059] As shown in
Results
Analysis of Tomodensitometric Sections
[0060] The results of the CT scans are presented in Table 1 below.
TABLE-US-00001 TABLE 1 Angles Measured in the 40 CT sections analyzed. Ramus Projection Patient Age Gender Reason for Exam Angle Angle 1 12 y F Impacted canine 37 53 2 59 y M Implant 22 53 3 42 y M Cyst 31 53 4 17 y M Impacted canine 35 53 5 41 y F Implant 36 54 6 25 y F Cyst 26 55 7 14 y M Impacted canine 26 55 8 14 y M Impacted canine 22 55 9 14 y M Impacted canine 37 55 10 36 y F Implant 31 55 11 38 y M Implant 35 56 12 41 y F Implants 42 56 13 13 y F Impacted canine 36 56 14 56 y F Implant 28 57 15 46 y F Third molar 42 57 16 57 y F Cyst 30 57 17 59 y M Implant 28 58 18 12 y F Impacted canine 36 58 19 42 y F Implant 31 58 20 38 y F Implant 35 60 21 59 y M Implant 29 60 22 55 y F Implant 35 61 23 14 y F Impacted canine 28 62 24 65 y M Implants 33 58 25 17 y M Impacted canine 26 55 26 54 y M Implants 26 59 27 22 y M Third molar 36 57 28 61 y M Implants 26 53 29 28 y M Implants 32 53 30 17 y M Impacted canine 36 56 31 64 y M Implant 29 54 32 39 y M Implants 32 53 33 13 y F Impacted canine 34 61 34 13 y F Impacted canine 38 60 35 37 y F Third molar 26 55 36 71 y M Implant 40 59 37 39 y M Implant 32 56 38 71 y M Implants 38 54 39 40 y F Implant 27 55 40 65 y F Implant 31 56 *Maximum and minimum values in bold.
[0061] The projection angle varied from 53 to 62, with an average of 56. The ramus angle varied from 22 to 42, with an average of 32.
[0062] Taking into account the variability among individuals, the inventor of the instant application configured the device so that its guiding axis would project against the medial surface of the mandibular ramus no more than 14.0 mm anterior to the posterior edge of the mandibular ramus for all patients (that is, always behind the mandibular foramen).
[0063] It was possible to record the orientation of the projection axis in relation to point R chosen on one of the tomodensitometric sections on the guiding device, such that the point of projection indicated by the device would contact bone 14.0 mm anterior to the posterior edge of the mandibular ramus. Because the projection angle varies among individuals, it was necessary to verify whether the position of the projection point indicated by the device is compatible with analgesia by superimposing the device at points R and D of other tomodensitometric sections. For this reason, sections from patients presenting the most extreme projection angles were analyzed, that from patient 1 presented the most closed projection angle (
[0064] When the orientation of the projection axis in relation to point R in patient 23 was recorded, and this point and the axis were superimposed on points R and D, respectively, in patient 1, the projection point P indicated by the device was in bone contact 24.0 mm anterior to point R (
[0065] Conversely, when the orientation of the projection axis in relation to point R in patient 1 was recorded and this point and this axis were superimposed on points R and D, respectively, in patient 23, the projection point P indicated by the device was in bone contact 7.0 mm anterior to point R (
[0066] Thus, the position of point R in relation to the projection axis established for patient 1 was used to configure the device, such that the projection axis protruded onto the medial surface of the mandibular ramus for all patients, at a distance of 7.0-14.0 mm anterior to the posterior edge of the mandibular ramus.
[0067] CT scans with the projection angles are shown in
[0068]
[0069] As shown in
[0070] As shown in
[0071] The causes of failure of anesthesia in current practice are varied. These causes may be due to a lack of knowledge of anatomical structures or to a lack of experience of the practitioner. One of the advantages of the device 10 of the invention described herein is to indicate the axis at which the needle must be applied to put its tip in contact with the bone above and posterior to the lingula. The device 10 applied against the occlusal surfaces of the maxillary teeth improves the practitioner's gestural precision by stabilizing the point of needle penetration. The device 10 of the invention can inject an analgesic solution above and behind the mandibular foramen in a reliable and reproducible manner.
[0072] It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications that are within the spirit and scope of the invention, as defined by the appended claims.