System for the preparation and administration of a tumescent solution for orthognathic surgery

Abstract

A system for preparing and administering a tumescent solution for maxillofacial surgery, comprising: (a) a preparation unit configured to facilitate the aseptic mixing of the components of the tumescent solution, which include physiological saline, bupivacaine, dexamethasone, hyaluronidase and adrenaline; b) a sterile container unit configured to hold the mixed tumescent solution; c) a delivery unit configured to deliver the tumescent solution to surgical sites during orthognathic surgical procedures; and d) a monitoring unit configured to measure and record intraoperative blood loss and postoperative parameters.

Description

FIELD OF THE INVENTION

[0001] The present disclosure relates to a system for preparing and administering a tumescent solution for oral surgery. More particularly, the present disclosure relates to a system for preparing and administering tumescent solutions for oral surgery to reduce intraoperative blood loss, minimize postoperative complications, and shorten hospital stays. BACKGROUND OF THE INVENTION

[0002] Orthodontic surgery has traditionally been associated with lengthy procedures involving significant blood loss, prolonged postoperative care, and longer hospital stays. Conventional approaches typically require intensive monitoring or intensive care unit (ICU) surveillance, blood transfusions, and long recovery periods to manage resumption of anesthesia, potential airway instability, hemostasis, pain control, and other surgery-related morbidities. These complications burden healthcare systems with increased costs and resource utilization. Although various techniques, including the administration of tranexamic acid, erythropoietin therapy, and hypotensive anesthesia, have been used to address these issues, significant challenges remain regarding intraoperative visibility, procedure duration, and recovery time.A transformative approach is needed to enable more efficient orthodontic procedures with fewer complications and shorter postoperative stays.

[0003] The state of the art shows that the infiltration of a very dilute local anesthetic solution and other additives into the tissue not only leads to effective anesthesia but also reduces the adverse effects of surgical injury.

[0004] From the foregoing discussion, it is clear that there is a need to prepare a tumescent solution and evaluate its efficacy in maxillofacial surgery. The present invention therefore proposes a system for preparing and administering tumescent solutions for maxillofacial surgery to reduce intraoperative blood loss, minimize postoperative complications, and shorten hospital stays. Summary of the invention

[0005] The present disclosure relates to a system for preparing and administering a tumescent solution for orthodontics. The present invention provides a comprehensive system for preparing and administering a tumescent solution specifically designed for maxillofacial surgery. The system enables the controlled combination of physiological saline, bupivacaine, dexamethasone, hyaluronidase, and epinephrine in precise amounts and facilitates targeted administration to critical surgical sites. Through local vasoconstriction, anesthesia, and anti-inflammatory effects, the tumescent solution significantly reduces intraoperative blood loss, improves visibility of the surgical field, and minimizes postoperative pain and swelling. The integrated monitoring functions enable precise measurement of blood loss and postoperative recovery parameters.The system is designed to be used in both single- and double-jaw surgeries. Average blood loss has already been reduced to approximately 264 ml and hospital stays shortened to approximately 1.2 days.

[0006] Another object of the present disclosure is to provide a system for preparing and administering a tumescent solution for maxillofacial surgery. The system comprises: a) a preparation unit for aseptically mixing the components of the tumescent solution, consisting of physiological saline, bupivacaine, dexamethasone, hyaluronidase, and adrenaline; b) a sterile container unit for holding the mixed tumescent solution; c) an administration unit for administering the tumescent solution to the surgical sites during maxillofacial surgery; and d) a monitoring unit for measuring and recording intraoperative blood loss and postoperative parameters.

[0007] Another object of the present disclosure is to provide a system for preparing and administering a tumescent solution for orthodontic surgery.

[0008] Another object of the present disclosure is a comprehensive system for preparing and administering a tumescent solution specifically designed for orthognathic surgical procedures.

[0009] Another object of the present disclosure is a system that significantly reduces intraoperative blood loss, improves visibility of the surgical field, and minimizes postoperative pain and swelling in orthognathic surgery.

[0010] Another object of the present disclosure is to provide a system that enables shorter hospital stays after orthognathic surgery through improved hemostasis and accelerated recovery.

[0011] Another objective of the present disclosure is to establish a standardized approach for administering a tumescent solution that can be adapted to various orthognathic procedures, including Le Fort osteotomy and bilateral sagittal split osteotomy.

[0012] To further clarify the advantages and features of the present disclosure, the invention will be explained in more detail with reference to specific embodiments illustrated in the accompanying drawings. These drawings illustrate only typical embodiments of the invention and are therefore not to be considered as limiting its scope. The invention will be described and explained in more detail with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE CHARACTERS

[0013] These and other features, aspects, and advantages of the present disclosure will become better understood when the following detailed description is read with reference to the accompanying drawings, in which like characters represent like parts throughout. Fig. 1 shows a block diagram of a system for preparing and administering a tumescent solution for jaw surgery according to an embodiment of the present disclosure. Fig. 2 shows a table illustrating the composition of the tumescent solution according to an embodiment of the present disclosure.

[0014] Those skilled in the art will also appreciate that the elements in the drawings are shown for convenience and are not necessarily to scale. For example, the flowcharts illustrate the method by key steps to enhance understanding of aspects of the present disclosure. Furthermore, with respect to device construction, one or more components of the device may be represented in the drawings by conventional symbols. The drawings may show only the specific details relevant to understanding embodiments of the present disclosure in order not to clutter the drawings with details that would be readily apparent to those skilled in the art from the present description. DETAILED DESCRIPTION:

[0015] To facilitate understanding of the principles of the invention, reference will now be made to the embodiment illustrated in the drawings and will be clearly described. However, the scope of the invention is not limited thereby. Changes and further modifications to the illustrated system, as well as further applications of the principles of the invention, are possible, as would normally occur to one skilled in the art to which the invention pertains.

[0016] It will be understood by those skilled in the art that the foregoing general description and the following detailed description are exemplary and explanatory of the invention and are not intended to be limiting thereof.

[0017] References in this specification to "one aspect," "another aspect," or similar language mean that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Therefore, the language "in one embodiment," "in another embodiment," and similar language throughout this specification may or may not refer to the same embodiment.

[0018] The terms "comprises," "comprising," or other variations thereof are intended to cover non-exclusive inclusion, such that a process or method comprising a list of steps may include not only those steps, but also additional steps not expressly listed or inherent in that process or method. Likewise, the statement "comprises" for one or more devices, subsystems, elements, structures, or components does not exclude, without further limitation, the existence of other devices, subsystems, elements, structures, components, or additional devices, subsystems, elements, structures, or components.

[0019] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. The systems, methods, and examples provided herein are for illustrative purposes only and should not be considered limiting.

[0020] Embodiments of the present disclosure will be described in detail below with reference to the accompanying drawings.

[0021] Fig. 1 shows a block diagram of a system (100) for preparing and administering a tumescent solution for orthodontics according to an embodiment of the present disclosure.

[0022] With reference to Fig. 1, the system (100) comprises: a preparation unit (102) configured to facilitate the aseptic mixing of the components of the tumescent solution, consisting of physiological saline, bupivacaine, dexamethasone, hyaluronidase, and adrenaline; a sterile receiving unit (104) configured to receive the mixed tumescent solution; an administration unit (106) configured to administer the tumescent solution to the surgical sites during orthognathic surgical procedures; and a monitoring unit (108) configured to measure and record intraoperative blood loss and postoperative parameters.

[0023] In one embodiment, the preparation unit (102) comprises: a sterile mixing vessel, calibrated syringes, and component storage compartments configured to maintain sterility during preparation of the tumescent solution.

[0024] In one embodiment, the preparation unit (102) is configured to prepare the tumescent solution by combining 500 ml of physiological saline, 10 ml of bupivacaine, 8 mg of dexamethasone, 1 vial of hyaluronidase, and 1 ml of adrenaline at a concentration of 1:1000.

[0025] In one embodiment, the administration unit (106) comprises: an injection device configured to deliver precisely measured amounts of the tumescent solution to specific surgical sites, including the piriformis area, the maxillary vestibular space, the pterygomaxillary region, the wisdom tooth region, and the vestibular area, in accordance with the planned orthognathic procedure.

[0026] In one embodiment, the delivery unit (106) is configured to deliver approximately 30 ml of the tumescent solution to each surgical incision site.

[0027] In one embodiment, the system further comprises a timing unit (110) configured to maintain a waiting time of 10 minutes between the administration of the tumescent solution and the start of the surgical procedure.

[0028] In one embodiment, the monitoring unit (108) comprises: a blood loss measurement module configured to quantify intraoperative blood loss based on swab weight calculations and suction chamber volume measurements.

[0029] In one embodiment, the monitoring unit (108) further comprises: an assessment module configured to evaluate and record postoperative parameters, including pain scores using a visual analog scale, measurements of facial swelling using stable facial features, and length of hospital stay.

[0030] In one embodiment, the prepared tumescent solution is configured to reduce intraoperative blood loss to an average of approximately 264 ml and shorten postoperative hospital stay in orthognathic surgical procedures to an average of approximately 1.2 days.

[0031] The present invention comprises a comprehensive system for the preparation and administration of a tumescent solution specifically developed for orthodontic surgical procedures. The system includes a preparation unit that allows for the aseptic combination of 500 ml of normal saline, 10 ml of bupivacaine, 8 mg of dexamethasone, 1 vial of hyaluronidase, and 1 ml of adrenaline (1:1000) under sterile conditions using calibrated syringes and a sterile mixing container. A collection unit ensures the sterility of the solution until administration, while the administration unit provides precise injection into specific surgical sites, including the piriformis area, the maxillary vestibular space, the pterygomaxillary area, the third molar area, and the vestibular area, according to the surgical plan. The system is designed to deliver approximately 30 ml of solution at each surgical incision.An integrated timing mechanism enforces a critical 10-minute waiting period between administration and surgical incision to achieve maximum vasoconstrictive effect. A sophisticated monitoring unit records intraoperative blood loss by calculating swab weight and measuring suction chamber volume, while also recording postoperative parameters such as pain scores using a visual analog scale, facial swelling by measuring stable facial features, and length of hospital stay. Implementation of the system has demonstrated significant clinical benefits, including a reduction in average intraoperative blood loss to 264 ml compared to conventional procedures (436.11 ml) and a reduction in average hospital stay by 1.2 days. No adverse events related to the use of the system occurred either intraoperatively or postoperatively.The comprehensive functionality of this system enables standardized application in orthognathic procedures on both single and double jaws, providing a transformative approach to these traditionally complex surgeries.

[0032] The use of tumescent solutions has proven effective in lipodermatosurgical procedures in day care and can be effectively adapted for applications in maxillofacial surgery. The present invention provides a system that enables the controlled infiltration of a precisely formulated, diluted anesthetic solution with specific additives into targeted tissue regions. This achieves both an effective anesthetic effect and a significant reduction in surgical insults. The administration of the tumescent solution has demonstrated significant benefits, including reduced complication rates, lower blood loss rates, and improved surgical visualization.These advantages are achieved through the system's adrenaline-induced vasoconstriction mechanism, hydrostatic compression generation capability, integration with hypotensive anesthesia systems, and compatibility with steep head positioning devices.

[0033] Fig. 2 shows a table illustrating the composition of the tumescent solution according to an embodiment of the present disclosure.

[0034] The Fig. The table shown in Figure 2 shows the composition of the tumescence solution, which contains physiological saline (500 ml), bupivacaine (10 ml), dexamethasone (8 mg), hyaluronidase (1 ampoule) and adrenaline (1 ml, 1:1000). The additional benefits of these components of the composition are as follows:

[0035] Normal saline is used for dilution or as a vehicle. Bupivacaine is used as a local anesthetic. Dexamethasone serves as a steroid. Hyaluronidase facilitates dissection of soft tissue and drying of the steroid. Adrenaline is used for vasoconstriction.

[0036] The proposed system enables the precise application of the tumescent solution to specific orthognathic surgical sites through dedicated preparation, administration, and monitoring units. The system's effectiveness is demonstrated by several measurement modules, including measurement of intraoperative blood loss, assessment of postoperative recovery, evaluation of pain and swelling, tracking of hospital length of stay, and analysis of hemoglobin concentration differences. The integrated preparation unit combines 500 ml of normal saline, 10 ml of bupivacaine, 8 mg of dexamethasone, 1 ampoule of hyaluronidase, and 1 ml of adrenaline (1:1000) under controlled sterile conditions.The delivery unit allows for targeted delivery to specific surgical sites, including the piriform region, maxillary vestibular space, pterygomaxillary region, wisdom tooth region, and vestibular area, depending on the specific orthognathic procedure. The system's time component enforces a critical 10-minute waiting time between solution delivery and the start of the surgical incision, while the monitoring unit tracks operative and postoperative parameters such as blood loss measurements, pain assessment results, edema quantification, and hospital length of stay.

[0037] The tumescent solution administered locally at the orthognathic surgical site resulted in a reduction in intraoperative blood loss, better postoperative recovery, and a reduction in postoperative pain and swelling, thus reducing the postoperative stay and the difference in hemoglobin concentration before and after surgery.

[0038] In an exemplary embodiment, 30 ml of tumescent solution as described in Fig.shown, injected locally at each surgical incision, depending on the surgical procedure required (single jaw or maxillary). For a Le Fort osteotomy, the solution is injected in the piriform region, the maxillary vestibular space, and the pterygomaxillary region. For a bilateral sagittal cleft osteotomy, the solution is injected in the wisdom tooth region and the vestibular region along the marked incision. After the injection, a waiting time of 10 minutes was allowed before the start of the surgery. The tumescent solution is prepared under aseptic conditions. The patients are properly dressed and mixed in a sterile bowl with a 20-ml syringe, 10 ml of bupivacaine (long-acting local anesthetic), 8 mg of dexamethasone (steroid), 1 ampoule of hyaluronidase, 1 ml of adrenaline (1:1000), and 500 ml of physiological saline. The patients receive the prepared tumescence solution.

[0039] In one embodiment, patients are assessed for the following parameters: intraoperative blood loss, postoperative pain, swelling on days 1, 3, and 7, and the length of postoperative stay. Intraoperative blood loss was carefully documented using the smear method, and blood volume was measured in the suction chamber. These values ​​were compared with the data. The mean intraoperative blood loss was 264 ml, significantly lower than the previously reported mean of 436.11 ml, with a standard deviation of 207.89 ml. Postoperative pain was assessed on days 1, 3, and 7 using the visual analogue scale (VAS). The mean VAS score on the first postoperative day was 4. Recovery was closely monitored, with edema assessed using tapes, Vernier gauges and calipers, and photographic measurements of stable facial features.The stable features were the bony features, the canthotragal line, and the line connecting the angle of the lip and the tragus. The average length of hospital stay was 1.2 days, shorter than those reported in previous studies. No adverse intraoperative events were associated with the tumescent solution, and postoperative follow-up was uneventful, with no complications observed. Potential advantages of using TLA include the low reported incidence of postoperative complications and reduced blood loss due to adrenaline-induced vasoconstriction and hydrostatic compression caused by the tumescent effect, combined with hypotensive anesthesia and steep head elevation.

[0040] The drawings and the foregoing description illustrate examples of embodiments. Those skilled in the art will recognize that one or more of the described elements may well be combined into a single functional element. Alternatively, certain elements may be separated into multiple functional elements. Elements of one embodiment may be added to another embodiment. For example, the order of the processes described herein may be changed and is not limited to the manner described herein. Furthermore, the actions of a flowchart need not be performed in the order shown; nor do all actions need to be performed. Also, actions that are not dependent on other actions may be performed in parallel with the other actions. The scope of the embodiments is in no way limited by these specific examples.Numerous variations, whether explicitly stated in the specification or not, such as differences in structure, dimensions, and use of materials, are possible. The scope of the embodiments is at least as broad as indicated in the following claims.

[0041] Advantages, further benefits, and solutions to problems have been described above with reference to specific embodiments. However, the advantages, advantages, solutions to problems, and any components that may result in or enhance an advantage, advantage, or solution are not to be construed as critical, required, or essential features or components of any or all of the claims. REFERENCES 100 System for preparing and administering a tumescent solution for orthognathic surgery. 102 Preparation Unit 104 Sterile Containment Unit 106 delivery units 108 Monitoring Unit 110 Time measurement unit

Claims

[1] A system for preparing and administering a tumescent solution for jaw surgery, comprising: (a) a preparation unit configured to facilitate the aseptic mixing of the components of the tumescent solution, which include physiological saline, bupivacaine, dexamethasone, hyaluronidase and adrenaline; b) a sterile container unit configured to hold the mixed tumescent solution; c) a delivery unit configured to deliver the tumescent solution to surgical sites during orthognathic surgical procedures; and d) a monitoring unit configured to measure and record intraoperative blood loss and postoperative parameters. [2] The system of claim 1, wherein the preparation unit comprises: a sterile mixing vessel, calibrated syringes, and component storage compartments configured to maintain sterility during preparation of the tumescent solution. [3] The system of claim 1, wherein the preparation unit is configured to prepare the tumescent solution by combining 500 ml of normal saline, 10 ml of bupivacaine, 8 mg of dexamethasone, 1 vial of hyaluronidase, and 1 ml of epinephrine at a concentration of 1:1000. [4] The system of claim 1, wherein the delivery unit comprises: an injection device configured to deliver precisely measured amounts of the tumescent solution to specific surgical sites, including the piriformis area, the maxillary vestibular space, the pterygomaxillary region, the wisdom tooth region, and the vestibular area, in accordance with the planned orthognathic procedure. [5] The system of claim 1, wherein the delivery unit is configured to deliver approximately 30 ml of the tumescent solution to each surgical incision site. [6] The system of claim 1, wherein the system further comprises a timing unit configured to maintain a waiting time of 10 minutes between the administration of the tumescent solution and the start of the surgical procedure. [7] The system of claim 1, wherein the monitoring unit comprises: a blood loss measurement module configured to quantify intraoperative blood loss based on swab weight calculations and suction chamber volume measurements. [8] The system of claim 1, wherein the monitoring unit further comprises: an assessment module configured to evaluate and record postoperative parameters, including pain scores using a visual analog scale, measurements of facial swelling using stable facial features, and length of hospital stay. [9] The system of claim 3, wherein the use of the prepared tumescent solution reduced intraoperative blood loss to a mean of approximately 264 ml and shortened postoperative hospital stay in orthognathic surgical procedures to an average duration of approximately 1.2 days.

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