Description:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(Section 10 and Rule 13)

1. TITLE OF THE INVENTION:
MODULAR LAPARSCOPIC MYOMA TRACTION DEVICE

2. APPLICANT:
Name : Meril Corporation (I) Private Limited
Nationality : Indian
Address : Survey No. 135/139, Muktanand Marg, Bilakhia House, Pardi, Vapi, Valsad - 396191, Gujarat, India

3. PREAMBLE TO THE DESCRIPTION
The following specification particularly describes the invention and the manner in which it is to be performed:
 
FIELD OF INVENTION
[001] The present invention relates to the field of medical devices. More specifically, the present invention pertains to a device for engaging and manipulating uterine fibroids.
BACKGROUND OF INVENTION
[002] Uterine fibroids are among the most prevalent benign tumors affecting women, and their surgical removal is frequently performed using minimally invasive techniques such as laparoscopic myomectomy. This approach offers advantages, including reduced postoperative pain, shorter recovery time, and minimal scarring. However, the effectiveness of the procedure significantly depends on the ability to securely engage and apply controlled traction to the fibroid during dissection and enucleation.
[003] During laparoscopic myomectomy, surgeons typically rely on traction devices that penetrate the fibroid tissue and allow manipulation within a confined intra-abdominal workspace. One of the most commonly used instruments is the manually operated myoma screw, which is rotated manually to anchor into the fibroid mass. While widely adopted, the functionality of such devices depends on the surgeon’s manual dexterity, strength, and experience.
[004] Conventional manually operated myoma screws suffer from several technical and ergonomic limitations. Firstly, the generation of adequate torque relies entirely on manual input, often requiring repetitive wrist rotation and substantial force, which can lead to surgeon fatigue during prolonged procedures. This fatigue may adversely affect procedural consistency and precision. Secondly, existing screw tip geometries are prone to either insufficient engagement, resulting in slippage, or excessive penetration, which may increase the risk of unintended injury to surrounding uterine tissue, bleeding, or compromised structural integrity of the uterus. Furthermore, manual operation introduces significant variability in critical parameters, including rotational speed, applied torque, and depth of penetration. Such variability reduces procedural predictability and may lead to inconsistent traction forces, thereby complicating fibroid manipulation and prolonging operative time. Additionally, conventional devices typically lack modularity and adaptability, limiting their effectiveness across fibroids of varying sizes, locations, and tissue characteristics.
[005] Thus, there is a need for a device that overcomes the problems associated with conventional devices.
OBJECT OF INVENTION
[006] An object of the present disclosure is to provide an improved device for removing fibroid tissue from a patient's body in a controlled and efficient manner.
[007] Yet another object of the present disclosure is to provide a device capable of enabling combined mechanical and thermal interaction with fibroid tissue during removal.
[008] Another object of the present disclosure is to provide a device configured to allow selective control of operational parameters during tissue removal.
[009] A further object of the present disclosure is to provide a device that improves precision, efficiency, and safety in fibroid tissue removal as compared to conventional techniques.
SUMMARY OF INVENTION
[0010] The present invention relates to a device for removing fibroid tissue from a patient's body. The device includes a hollow shaft, a cutting element, a drive unit, a heating element, and a control unit. The hollow shaft extends longitudinally between a proximal end and a distal end thereof. The cutting element extends longitudinally between a proximal end and a distal end thereof. The proximal end of the cutting element is coupled to the distal end of the hollow shaft, and the distal end of the cutting element is configured to incise fibroid tissue. The drive assembly is coupled to the proximal end of the hollow shaft. The drive assembly includes a drive unit, a drive gear, and a driven gear. The drive unit is configured to provide a rotational output. The drive gear is coupled to the drive unit. The driven gear is disposed at the proximal end of the hollow shaft and engaged with the drive gear to transmit the rotational output to the hollow shaft. The heating element is disposed within the hollow shaft and coupled to the proximal end of the cutting element. The control unit is coupled to the drive assembly and the heating element. The control unit is configured to: (i) selectively actuating the drive assembly to rotate the hollow shaft in at least one of a clockwise direction or a counterclockwise direction and (ii) regulating the temperature of the heating element. The control unit is configured to perform at least one of (i) pr (ii) based on an operational condition.
[0011] The foregoing features and other features as well as the advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
BRIEF DESCRIPTION OF DRAWINGS
[0012] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[0013] Fig. 1A depicts a perspective view of a device 100, in accordance with an embodiment of the present disclosure.
[0014] Fig. 1B depicts an exploded view of the device 100, in accordance with an embodiment of the present disclosure.
[0015] Fig. 1C depicts a longitudinal cross-sectional view of the device 100, in accordance with an embodiment of the present disclosure.
[0016] Fig. 2 depicts a perspective view of a cutting element 110 of the device 100, in accordance with an embodiment of the present disclosure.
[0017] Fig. 3 depicts a perspective view of a portion of a hollow shaft 130 of the device 100, in accordance with an embodiment of the present disclosure.
[0018] Fig. 4 depicts a perspective view of a portion of a heating element 120 of the device 100, in accordance with an embodiment of the present disclosure.
[0019] Fig. 5 depicts a perspective view of a drive assembly 150 with a plurality of switches 170 of the device 100, in accordance with an embodiment of the present disclosure.
[0020] Fig. 6 depicts a perspective view of the device 100 without the handle 190, in accordance with an embodiment of the present disclosure.
[0021] Fig. 7 depicts a flowchart of a method 700 for removing uterine fibroids from a patient’s body using the device 100, in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[0022] Prior to describing the invention in detail, definitions of certain words or phrases used throughout this patent document will be defined: the terms "include" and "comprise", as well as derivatives thereof, mean inclusion without limitation; the term "or" is inclusive, meaning and/or; the phrases "coupled with" and "associated therewith", as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have a property of, or the like; Definitions of certain words and phrases are provided throughout this patent document, and those of ordinary skill in the art will understand that such definitions apply in many, if not most, instances to prior as well as future uses of such defined words and phrases.
[0023] Reference throughout this specification to “one embodiment,” “an embodiment,” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment,” “in an embodiment,” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment, but mean “one or more but not all embodiments” unless expressly specified otherwise. The terms “including,” “comprising,” “having,” and variations thereof mean “including but not limited to” unless expressly specified otherwise. An enumerated listing of items does not imply that any or all of the items are mutually exclusive and/or mutually inclusive, unless expressly specified otherwise. The terms “a,” “an,” and “the” also refer to “one or more” unless expressly specified otherwise.
[0024] Although the operations of exemplary embodiments of the disclosed method may be described in a particular, sequential order for convenient presentation, it should be understood that the disclosed embodiments can encompass an order of operations other than the particular, sequential order disclosed. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Further, descriptions and disclosures provided in association with one particular embodiment are not limited to that embodiment, and may be applied to any embodiment disclosed herein. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed system, method, and apparatus can be used in combination with other systems, methods, and apparatuses.
[0025] Furthermore, the described features, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all embodiments. These features and advantages of the embodiments will become more fully apparent from the following description and apportioned claims, or may be learned by the practice of embodiments as set forth hereinafter.
[0026] The present disclosure relates to a device capable of delivering controlled, power assisted engagement and manipulation of uterine fibroids. The device is configured to minimize fatigue and manual force requirements, thereby providing precise torque rotation, consistent operational performance, and enhanced procedural safety. The device facilitates controlled penetration and stable anchoring to reduce trauma to the surrounding uterine tissue.
[0027] Figs. 1A – 1C depict prospective views of a device 100 for removing a fibroid tissue from a patient’s body, in accordance with an embodiment of the present disclosure. The device 100 is a laparoscopic surgical device configured to perform surgical functions, including engaging, grasping, manipulating, dissecting, or applying traction to tissue. In particular, the device 100 is configured to remove fibroid tissue from the patient's body during a laparoscopic myomectomy procedure. In an embodiment, the device 100 extends between a proximal end 100a and a distal end 100b, which serve as directional references for describing the corresponding ends of the various components of the device 100. In an embodiment, the device 100 includes a cutting element 110, a heating element 120, a hollow shaft 130, an insulation tube 140, a drive assembly 150, a control unit 160, a plurality of switches 170, an electrical coupling mechanism 180, and a handle 190.
[0028] The handle 190 is disposed at the proximal end 100a of the device 100 and is coupled to the hollow shaft 130. The handle 190 is adapted to accommodate one or more components of the device 100. Specifically, the handle 190 is adapted to house the drive assembly 150 and the plurality of switches 170, the control unit 160, thereby enabling compact integration of mechanical and control components within a single housing of the handle 190. In an embodiment, the handle 190 may be ergonomically shaped to facilitate comfortable gripping and precise manipulation by a user during the laparoscopic procedure. The handle 190 is configured to provide structural support and protection to the drive assembly 150 and associated internal components of the device 100.
[0029] The cutting element 110 is operatively coupled to the drive assembly 150 via the hollow shaft 130, as depicted in Fig. 1C, such that actuation of the drive assembly 150 causes rotation of the hollow shaft 130 and the cutting element 110. The heating element 120 is electrically coupled to the control unit 160 through the electrical coupling mechanism 180, as depicted in Fig. 1C. The heating element 120 is at least partially disposed within the hollow shaft 130, as depicted in Fig. 1C, such that rotation of the hollow shaft 130 causes corresponding rotation of the heating element 120. The electrical coupling mechanism 180 is configured to maintain electrical continuity while preventing transmission of rotational motion to an external power cable 195. The insulation tube 140 is disposed over the hollow shaft 130, as depicted in Fig. 1C, and is configured to prevent heat dissipation. The insulation tube 140 thermally and electrically isolates the hollow shaft 130 and the heating element 120 from surrounding components and non-target tissue, while permitting exposure of a defined operative portion of the heating element 120. The control unit 160 is coupled to the drive assembly 150 and the heating element 120 and configured to selectively regulate the rotational operation of the cutting element 110 and the temperature of the heating element 120 based on input received from the plurality of switches 170. The plurality of switches 170 is disposed on the handle 190 to enable user actuation for controlling at least one of rotational speed, rotational direction, activation state, and temperature of the heating element 120, as depicted in Fig. 1B. The combined rotational cutting and controlled heating enable simultaneous incision and cauterization, thereby reducing intraoperative bleeding and improving procedural efficiency.
[0030] Fig. 2 depicts a perspective view of the cutting element 110, in accordance with an embodiment of the present disclosure. The cutting element 110 is disposed at the distal end 100b of the device 100 and configured to incise the fibroid tissue. In an embodiment, the cutting element 110 is adapted to undergo rotational movement about a longitudinal axis, such as rotation being imparted by the hollow shaft 130. The rotational movement enables progressive engagement of the cutting element 110 with the fibroid tissue, facilitating controlled penetration and removal. The rotational cutting action further enables precise insertion while minimizing trauma to surrounding healthy tissue, thereby enhancing procedural accuracy and safety.
[0031] In an embodiment, the cutting element 110 extends longitudinally between a proximal end and a distal end thereof. The proximal end of the cutting element 110 is coupled to the distal end of the hollow shaft 130, enabling transmission of motion thereto. The distal end of the cutting element 110 is configured to engage with the fibroid tissue during a surgical procedure. In an embodiment, the proximal end of the cutting element 110 is configured to be removably coupled to the hollow shaft 130 through a coupling mechanism. The coupling mechanism may include, but is not limited to, threaded coupling, press-fit engagement, snap-fit arrangement, bayonet locking, or any equivalent detachable fastening means. The coupling mechanism enables the cutting element 110 to be selectively engaged with the hollow shaft 130 during operation and disengaged when required. The detachable nature of the cutting element 110 facilitates convenient replacement in the event of wear, damage, or the need to use the cutting element 110 of varying specifications. Further, the ability to disengage the cutting element 110 allows thorough cleaning and sterilization of both the cutting element 110 and the hollow shaft 130, thereby maintaining hygiene and operational efficiency. This arrangement also enhances ease of maintenance and supports repeated reuse of the device 100 without requiring replacement of the entire assembly.
[0032] The cutting element 110 includes a cutting portion 112 disposed at the distal end of the cutting element 110. The cutting portion 112 is configured to incise, penetrate, and advance into fibroid tissue upon rotation of the cutting element 110. The cutting portion 112 may include a sharp or pointed geometry to facilitate precise incision. The cutting portion 112 includes a contoured outer profile having a progressively tapered geometry that facilitates gradual entry into the tissue. In an embodiment, the cutting portion 112 is provided with a helical or thread-like cutting profile along at least a portion of its length, such profile being configured to assist in drawing the fibroid tissue inwardly during rotation, thereby enabling controlled and continuous cutting. Further, the cutting element 110 includes a piercing tip 114 disposed at a distal end of the cutting portion 112. The piercing tip 114 is configured to puncture the fibroid tissue prior to engagement of the cutting portion 112. The piercing tip 114 includes a sharpened and converging structure adapted to reduce insertion force and enable accurate positioning within the tissue.
[0033] The cutting element 110 includes a plurality of external threads 116 disposed at the proximal end of the cutting element 110. The plurality of external threads 116 of the cutting element 110 is configured to threadably engage with the corresponding coupling portion of the hollow shaft 130, thereby enabling transmission of rotational motion and conversion of rotational movement into axial advancement or withdrawal of the cutting element 110, thereby enabling controlled incision of uterine fibroid tissue. Further, the cutting element 110 includes an internal coupling portion 118 disposed at the proximal end and partially extends towards the distal end of the cutting element 110. The internal coupling portion 118 is configured to receive a distal portion of the heating element 120. In an embodiment, the internal coupling portion 118 includes a plurality of internal threads 118a formed along an inner surface thereof. The internal threads 118a of the internal coupling portion 118 are separately configured to engage with the corresponding coupling portion of the heating element 120, thereby establishing an independent mechanical and thermal interface between the heating element 120 and the cutting element 110. In an embodiment, the internal coupling portion 118 establishes a thermal interface between the heating element 120 and the cutting element 110, allowing transfer of heat to the cutting element 110 during a laparoscopic procedure.
[0034] Fig. 3 depicts a perspective view of the hollow shaft 130, in accordance with an embodiment of the present disclosure. The hollow shaft 130 extends longitudinally between a proximal end and a distal end thereof. The distal end is coupled to the proximal end of the cutting element 110, and the proximal end is coupled to the drive assembly 150. The hollow shaft 130 facilitates the transmission of rotational motion from the drive assembly 150 to the cutting element 110. The hollow shaft 130 is configured to rotate about a longitudinal axis of the hollow shaft 130 in response to actuation of the drive assembly 150. In an embodiment, the hollow shaft 130 defines a lumen extending therethrough and configured to receive the heating element 120. Further, the hollow shaft 130 includes a distal coupling portion 132 disposed on an inner surface of the lumen and partially extending towards the proximal end thereof. In an embodiment, the distal coupling portion 132 has a plurality of internal threads 132a. The distal coupling portion 132 receives such that the plurality of internal threads 132a engages with the plurality of external threads 116 of the cutting element 110. The hollow shaft 130 ensures efficient transmission of rotational motion to the cutting element 110 for precise cutting during the laparoscopic procedure.
[0035] Fig. 4 depicts a perspective view of the heating element 120, in accordance with an embodiment of the present disclosure. The heating element 120 is configured to be disposed within the hollow shaft 130 and coupled to the proximal end of the cutting element 110. The heating element 120 is configured to elevate the temperature of the cutting element 110 during the laparoscopic procedure. The elevated temperature enables cauterization of uterine fibroid tissue concurrently with incision. In an embodiment, the heating element 120 is electrically connected to the external power cable 195 via the electrical coupling mechanism 180 provided at the proximal end of the device 100 and the control unit 160.
[0036] In an embodiment, the heating element 120 extends longitudinally between a proximal end and a distal end thereof. The distal end of the heating element 120 is coupled to the proximal end of the cutting element 110. The proximal end of the heating element 120 is electrically coupled to the electrical power cable 195 via the electrical coupling mechanism 180, which is configured to deliver electrical power from the external power cable 195 to the heating element 120. In an embodiment, the heating element 120 includes an external coupling portion 122 disposed at the distal end of the heating element 120. The external coupling portion 122 is configured to be disposed within the internal coupling portion 118 of the cutting element 110 (in other words, the internal coupling portion 118 is configured to receive and retain the external coupling portion 122 of the heating element 120 therein). In an embodiment, the external coupling portion 122 includes a plurality of external threads 122a that mate with corresponding internal threads 118a of the internal coupling portion 118 of the cutting element 110. The engagement between the cutting element 110 and the heating element 120 establishes both mechanical and thermal connectivity between the heating element 120 and the cutting element 110.
[0037] Fig. 5 depicts a perspective view of the drive assembly 150, in accordance with an embodiment of the present disclosure. The drive assembly 150 is disposed within the handle 190 and coupled to the proximal end of the hollow shaft 130, as depicted in Fig. 6. The drive assembly 150 is configured to rotate the hollow shaft 130 about a longitudinal axis thereof. In an embodiment, the drive assembly 150 is configured to selectively impart bidirectional rotational movement to the hollow shaft 130, including clockwise rotation and counterclockwise rotation. The rotational movement of the hollow shaft 130 corresponds to a controlled axial advancement and retraction of the cutting element 110 relative to the uterine fibroid tissue. Specifically, the drive assembly 150 imparts clockwise rotation to the hollow shaft 130, causing insertion of the cutting element 110 into the fibroid tissue. Conversely, the drive assembly 150 imparts counterclockwise rotation to the hollow shaft 130, causing retraction of the cutting element 110 from the fibroid tissue, enabling controlled removal. The assembly of the drive assembly 150 provides precise control over rotational direction and extent of movement, enabling accurate positioning, insertion, and extraction of the cutting element 110 while maintaining procedural stability.
[0038] In an embodiment, the drive assembly 150 includes a drive unit 152, a drive gear 154, and a driven gear 156. The drive unit 152 is configured to provide a rotational output. The drive unit 152 is configured to generate bidirectional rotational movement. In an embodiment, the drive unit 152 include a motor configured to rotate in both clockwise and counterclockwise directions. The drive unit 152 is coupled to the plurality of switches 170. The drive unit 152 is responsive to actuation signals received from the control unit 160 and the plurality of switches 170, thereby enabling selective control over the direction, speed, and duration of rotation. The drive gear 154 is operatively coupled to the drive unit 152 and is configured to rotate in response to the rotational movement of the drive unit 152. The drive gear 154 may be configured with a predetermined gear profile and size to achieve a desired rotational speed and torque output. The drive gear 154 thus functions as an intermediate transmission component that converts and transfers rotational motion from the drive unit 152 to the driven gear 156.
[0039] The driven gear 156 is disposed at the proximal end of the hollow shaft 130 and is fixedly coupled thereto. The driven gear 156 engaged with the drive gear 154 and transmits the rotational output to the hollow shaft 130. The rotation of the drive gear 154 corresponds to the rotation of the driven gear 156. The engaging configuration ensures synchronized motion transfer and minimizes slippage, thereby enabling consistent and reliable rotation of the hollow shaft 130. The gear engagement between the drive gear 154 and the driven gear 156 is configured to provide a desired gear ratio as required for the laparoscopic procedure. The gear engagement ensures smooth operation, minimizes mechanical vibrations, and enhances precision during the myomectomy procedure.
[0040] The control unit 160 is coupled to the drive assembly 150, the plurality of switches 170, and the heating element 120, as depicted in Fig. 1B. The control unit 160 is configured to coordinate the mechanical and thermal operations of the device 100 to ensure precise and controlled performance during the laparoscopic procedure. In an embodiment, the control unit 160 may include a microcontroller, microprocessor, programmable logic controller (PLC), application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), or any other suitable programmable computing device capable of executing stored instructions for controlling operation of the device 100. The control unit 160 may further include one or more communication interfaces (wired and/or wireless), input/output (I/O) ports, analog-to-digital and digital-to-analog converters, signal conditioning circuits, isolation modules, and power management units to enable reliable and coordinated interaction with the corresponding components of the device 100.
[0041] The control unit 160 is configured to at least one of: (i) selectively actuate the drive unit 152 of the drive assembly 150 to drive the cutting element 110 to incise the fibroid tissue, and (ii) regulate the temperature of the heating element 120 to heat the cutting element 110, thereby burning the fibroid tissue. In an embodiment, the cutting element 110 rotates about the longitudinal axis thereof in at least one of the clockwise direction or the counterclockwise direction. The control unit 160 may further regulate the speed and duration of rotation to ensure smooth and precise engagement of the cutting element 110 with uterine fibroid tissue. Further, the control unit 160 is configured to regulate the temperature of the heating element 120, thereby burning the fibroid tissue. The control unit 160 may regulate the supply of electrical power to the heating element 120 to achieve and maintain a desired temperature range suitable for cauterization. The control unit 160 is configured to enable selective activation and deactivation of the heating element 120 based on user input. The control unit 160 includes safety and control features such as limiting excessive temperature, preventing unintended activation of the heating element 120, and synchronizing the operation of the drive assembly 150 and the heating element 120. The control unit 160 ensures that the cutting element 110 performs simultaneous incision and cauterization in a controlled manner, thereby reducing the risk of tissue damage and enhancing the overall safety and effectiveness of the laparoscopic procedure.
[0042] In an embodiment, the control unit 160 is configured to perform at least one of: selectively actuation of the drive unit 152 or selectively actuation of the heating element 120 based on an operational condition. The operational conditions may include, but are not limited to, a position of the hollow shaft 130, a load or torque associated with the drive unit 152, a state of engagement between the cutting element 110 and the tissue, a temperature of the heating element 120, a completion of a preceding operational step, or an input received from the user interface or one or more sensors. The control unit 160 is further configured to initiate, modulate, or terminate actuation of the drive unit 152. Accordingly, the control unit 160 ensures coordinated operation of the cutting element 110 and the heating element 120 to perform simultaneous incision and cauterization in a controlled manner, thereby reducing a risk of unintended tissue damage and enhancing safety and effectiveness of the laparoscopic procedure.
[0043] The plurality of switches 170 (as shown in Fig. 5) is operatively coupled to the drive unit 152 and the control unit 160 and is configured to provide discrete control over rotational and thermal operations of the device 100. At least one switch of the plurality of switches 170 is configured to selectively actuate the drive unit 152 to impart rotational movement to the hollow shaft 130, thereby causing corresponding rotation of the cutting element 110 in the clockwise direction or the counterclockwise direction for a predetermined time interval. The predetermined time interval is a calibrated temporal value stored in the control unit 160 and correlated with a rotational speed of the drive unit 152 and a pitch characteristic of the cutting element 110 or an associated threaded interaction, such that each actuation produces a discrete and repeatable axial displacement of the cutting element 110 in either an advancement direction or a retracted direction. In an embodiment, the predetermined time interval corresponds to a pulse duration in the range of milliseconds to seconds, and each actuation results in a fixed incremental axial movement of the cutting element 110, thereby enabling controlled, step-wise advancement and controlled, step-wise removal of the cutting element 110.
[0044] In an embodiment, the plurality of switches 170 is configured to actuate the drive unit 152 to rotate the cutting element 110 in the clockwise direction or in the counterclockwise direction for the predetermined time interval. The plurality of switches 170 is configured to generate a control signal upon actuation, which is transmitted to the control unit 160 and directly to the drive unit 152 to initiate rotational movement. In an embodiment, the plurality of switches 170 may include, but are not limited to, push buttons, toggle switches, or touch-sensitive inputs configured to provide user-controlled operation of the device 100.
[0045] In an embodiment, the plurality of switches 170 includes a first switch 172 and a second switch 174. The first switch 172 is configured to actuate the drive unit 152 to rotate the hollow shaft 130 in the clockwise direction for the insertion of the cutting element 110. The engagement between the cutting element 110 and the hollow shaft 130 gradually advances during the clockwise rotation of the cutting element 110, thereby allowing controlled penetration and precise incision of the target tissue. In an embodiment, the actuation of the first switch 172 may be configured to operate for a predetermined time interval or until the first switch 172 is released, thereby providing controlled and incremental insertion of the cutting element 110. The second switch 174 is configured to actuate the drive unit 152 to rotate the hollow shaft 130 in the counterclockwise direction for the removal of the cutting element 110. The threaded engagement between the cutting element 110 and the hollow shaft 130 facilitates gradual retraction of the cutting element 110 during the counterclockwise rotation, thereby enabling controlled withdrawal of the cutting element 110 from the uterine fibroid tissue. In an embodiment, the actuation of the second switch 174 may be configured to operate for a predetermined time interval or until the second switch 174 is released, thereby providing controlled and incremental removal of the cutting element 110. The reverse rotation ensures smooth extraction of the cutting element 110 while minimizing damage to surrounding tissue and enhancing procedural safety.
[0046] Additionally, or optionally, the plurality of switches 170 includes a third switch (not shown) that is operatively coupled to the control unit 160 and is configured to control the operation of the heating element 120. The third switch is configured to generate a control signal to selectively initiate, terminate, or regulate electrical power supplied to the heating element 120, thereby controlling the temperature of the cutting element 110 for simultaneous cauterization during tissue incision. The control unit 160 regulates the thermal output in accordance with a predefined temperature range to prevent excessive heating and ensure controlled thermal interaction with fibroid tissue.
[0047] The electrical coupling mechanism 180 is configured to maintain an electrical connection with the heating element 120 while restricting transmission of rotational movement from the shaft 130 to the external power cable 195, as depicted in Fig. 180. The electrical coupling mechanism 180 is configured to deliver electrical current from the external power cable 195 to the heating element 120, which in turn transfers thermal energy to the cutting element 110 during the laparoscopic procedure. This electrical connection facilitates effective heating of the cutting element 110 for simultaneous incision and cauterization of uterine fibroid tissue. In an embodiment, a proximal end of the electrical coupling mechanism 180 is electrically and mechanically coupled to a proximal electrical connector. The electrical connector is configured to interface with an external power source, thereby enabling the controlled supply of electrical energy to the heating element 120. In an embodiment, the electrical coupling mechanism 180 may comprise an electrically conductive material such as copper or an equivalent conductive alloy to ensure efficient transmission of electrical current.
[0048] The insulation tube 140 is disposed over the hollow shaft 130 and configured to prevent heat dissipation, as depicted in Fig. 6. The insulation tube 140 is configured to minimize unintended heat transfer to surrounding tissues during the laparoscopic procedure of the heating element 120. The insulation tube 140 may be formed of a thermally insulating and biocompatible material, and is configured to encase the hollow shaft 130 along its longitudinal length. The insulation tube 140 further provides a protective barrier that enhances patient safety by reducing the risk of thermal injury and electrical exposure.
[0049] An exemplary working of the device 100 is explained below. During the laparoscopic myomectomy procedure, the device 100 is introduced into a surgical site such that the cutting element 110 is positioned adjacent to a target fibroid tissue. Upon positioning, the first switch 172 is actuated to energize the drive unit 152 for the predetermined time interval, causing clockwise rotation of the hollow shaft 130 and the cutting element 110. The clockwise rotation, in combination with the cutting portion 112 of the cutting element 110 enable controlled axial advancement of the cutting element 110 into the fibroid tissue. Further, repeated actuation of the first switch 172 produces incremental forward advancement of the cutting element 110, allowing step-wise penetration into the fibroid tissue.
[0050] Upon completion of the cutting operation and reaching a desired depth. Additionally, or optionally, the third switch is actuated to activate the heating element 120, thereby elevating the temperature of the cutting element 110 to a predefined range suitable for cauterization. The simultaneous application of heat and rotational cutting enables incision and cauterization of the fibroid tissue, thereby reducing bleeding and improving cutting efficiency.
[0051] Upon completion of the cutting operation, the second switch 174 is actuated to energize the drive unit 152 for the predetermined time interval in a reverse direction, thereby causing counterclockwise rotation of the hollow shaft 130 and corresponding axial retraction of the cutting portion 112 of the cutting element 110 from the fibroid tissue. The reverse rotation, in combination with continued or selective thermal application, facilitates controlled burning and separation of the engaged tissue during withdrawal, thereby enabling smooth extraction.
[0052] The control unit 160 coordinates the operation of the drive unit 152 and the heating element 120 based on input from the plurality of switches 170, thereby ensuring controlled rotational movement and regulated thermal output throughout the procedure. Upon completion of the procedure, the heating element 120 is deactivated via the third switch 176, and the device 100 is withdrawn from the surgical site.
[0053] Fig. 7 depicts a flowchart of a method 700 for removing uterine fibroids from a patient’s body using the device 100, according to an embodiment of the present disclosure. The method 700 provides a stepwise procedural framework for controlled insertion, incision, thermal burning, cauterization, and removal of uterine fibroid tissue using the device 100. The method 700 includes the following steps.
[0054] At step 702, position the device 100 at the target location, such that the cutting element 110 is aligned with the fibroid tissue. In an embodiment, the distal end 100b of the device 100 is introduced into the patient’s body through a laparoscopic port and is guided toward the uterine fibroid tissue, as explained earlier.
[0055] At step 704, actuate the drive unit 152 to rotate the cutting element 110 in the clockwise direction, thereby causing axial advancement of the cutting element 110 into the fibroid tissue, as explained earlier.
[0056] At step 706, optionally activate the heating element 120 to elevate the temperature of the cutting element 110 for burning and cauterizing the fibroid tissue during or after insertion, as explained earlier.
[0057] At step 708, actuate the drive unit 152 to rotate the cutting element 110 in the clockwise direction, thereby causing axial withdrawal of the cutting element 110 from the fibroid tissue, as explained earlier.
[0058] At step 710, remove the device 100 from the patient’s body along with or after disengagement from the fibroid tissue, as explained earlier.
[0059] The device of the present disclosure provides significant advantages in performing the laparoscopic procedure. The device integrates the rotatable cutting element with a heating element, thereby enabling simultaneous incision and cauterization of uterine fibroid tissue. The controlled rotational movement of the cutting element enhances surgical accuracy and minimizes unintended damage to surrounding healthy tissue. The integration of the heating element with the cutting element facilitates real-time cauterization during incision, thereby reducing bleeding and improving the overall efficiency and safety of the laparoscopic procedure. The control unit and the plurality of switches allow intuitive and precise control over both rotational movement and temperature regulation. The ability to control direction, speed, and duration of rotation, along with selective activation of the heating element, enhances operational safety and reliability. The outer tube provides thermal insulation, thereby preventing unintended heat transfer to surrounding tissues and enhancing patient safety.
[0060] The device achieves controlled engagement and disengagement of fibroid tissue during laparoscopic myomectomy. The inclusion of a single switch control member enables simplified selection of rotational direction, enhancing handling precision and reducing the complexity of instrument manipulation during the procedures. The combination of the detachable tip, the hollow shaft, and the hollow shaft driver assembly establishes the secure interface that maintains stable rotational alignment and reduces tip slippage, over penetration, and breakage during the procedure.
[0061] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:WE CLAIM
1. A device (100) for removing a fibroid tissue from a patient's body, the device (100) comprising:
a. a hollow shaft (130) extending longitudinally between a proximal end and a distal end thereof;
b. a cutting element (110) extending longitudinally between a proximal end and a distal end thereof, the proximal end of the cutting element (110) coupled to the distal end of the hollow shaft (130);
c. a drive assembly (150) coupled to the proximal end of the hollow shaft (130) and configured to rotate the hollow shaft (130);
d. a heating element (120) disposed within the hollow shaft (130) and coupled to the proximal end of the cutting element (110); and
e. a control unit (160) coupled to the drive assembly (150) and the heating element (120), the control unit (160) is configured to at least one of:
i. selectively actuate the drive assembly (150) to drive the cutting element (110) to incise a fibroid tissue; and
ii. regulate the temperature of the heating element (120) to heat the cutting element (110), thereby burning the fibroid tissue.
2. The device (100) as claimed in claim 1, wherein the drive assembly (150) comprises:
a. a drive unit (152) configured to provide a rotational output;
b. a drive gear (154) coupled to the drive unit (152); and
c. a driven gear (156) disposed at the proximal end of the hollow shaft (130) and engaged with the drive gear (154) to transmit the rotational output to the hollow shaft (130);
3. The device (100) as claimed in claim 1, wherein the drive unit (152) is coupled to a plurality of switches (170), at least one switch of the plurality of switches (170) configured to actuate the drive unit (152) to rotate the cutting element (110) in a clockwise direction or a counterclockwise direction for a predetermined time interval.
4. The device (100) as claimed in claim 2, wherein the device (100) comprises a handle (190) adapted to accommodate the drive assembly (150) and the plurality of switches (170).
5. The device (100) as claimed in claim 1, wherein the heating element (120) is electrically connected to an external power source via an electrical coupling mechanism (180) provided at the proximal end of the device (100), the electrical coupling mechanism (180) is configured to maintain an electrical connection with the heating element (120).
6. The device (100) as claimed in claim 5, wherein the electrical coupling mechanism (180) is configured to restrict transmission of rotational movement from the hollow shaft (130) to the external power source.
7. The device (100) as claimed in claim 1, wherein the cutting element (110) comprises a cutting portion (112) disposed at the distal end of the cutting element (110) and configured to incise the fibroid tissue.
8. The device (100) as claimed in claim 1, wherein
a. the cutting element (110) comprises:
i. a plurality of external threads (116) disposed at the proximal end thereof;
b. the hollow shaft (130) comprises:
i. a distal coupling portion (132) having a plurality of internal threads (132a), the distal coupling portion (132) receive and engaged with the plurality of external threads (116) of the cutting element (110).
9. The device (100) as claimed in claim 1, wherein
a. the heating element (120) comprises:
i. an external coupling portion (122) disposed at the distal end thereof;
b. the cutting element (110) comprises:
i. an internal coupling portion (118) disposed at the proximal end and partially extends towards the distal end of the cutting element (110) and configured to receive and retain the external coupling portion (122) of the heating element (120) therein.
10. The device (100) as claimed in claim 1, wherein the device (100) comprises an insulation tube (140) disposed over the hollow shaft (130) and configured to prevent heat dissipation.