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

TITLE OF THE INVENTION
TISSUE REMOVAL DEVICE

APPLICANT:
Meril Corporation (I) Private Limited, an Indian company of the address Survey No. 135/139, Muktanand Marg, Bilakhia House, Pardi, Vapi, Valsad-396191 Gujarat, India.

The following specification particularly describes the invention and the manner in which it is to be performed:

FIELD OF INVENTION
[1] The present disclosure relates to a medical instrument. More particularly, the present disclosure relates to a tissue removal device.
BACKGROUND OF INVENTION
[2] Tissue removal devices are specialized surgical instruments practiced to remove or excise a specimen such as soft tissues, bones or any other specified material for diagnostic or therapeutic purposes. Commonly, the tissue removal devices are used during invasive surgeries and minimal invasive surgical procedures. Tissue removal device can be used in surgical procedures such as orthopedics, neurosurgery, ENT, general surgery, etc. Existing tissue removal instruments often present challenges in terms of size, reusability, and safety. The cumbersome and heavy nature of traditional tissue removal devices leads to blockages during device reuse. They are also difficult to transporting to different operating rooms. Additionally, the risk of cross-contamination associated with reusable devices poses a significant concern in medical settings.
[3] Current tissue removal devices necessitate large sized components, demanding a substantial initial investment and making the overall usage more complicated. Reusable consumables, for example, blades, though cost-efficient, bring about cross-contamination risks if not adequately sterilized, thereby compromising patient safety. Furthermore, existing technologies pose challenges in controlling power and torque throughout surgical procedures due to lack of compact tissue removal devices.
[4] Therefore, there arises a need for a tissue removal device that overcomes the problems associated with the conventional devices.
SUMMARY OF THE INVENTION
[5] Particular embodiments of the present disclosure are described herein below with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are mere examples of the disclosure, which may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
[6] The present disclosure relates to a tissue removal device. In an embodiment, the tissue removal device includes a housing, a motor, a motor gear, a rotor gear and an inner tube assembly. The motor is disposed within the housing and is configured to rotate. The motor includes a motor shaft. The motor gear disposed within the housing and is rotatably coupled to the motor shaft. The rotor gear is disposed within the housing and is rotatably coupled to the motor gear. The inner tube assembly includes an inner shaft rotatably coupled to the rotor gear. The inner shaft has a first blade provided at a distal end of the inner shaft. In response to the rotation of the motor, the inner shaft and the first blade are configured to rotate. The inner shaft is partially disposed outside the housing, and the inner shaft and the first blade are non-detachable from the housing.
BRIEF DESCRIPTION OF DRAWINGS
[7] 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 instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[8] FIG. 1 illustrates a schematic view of a tissue removal device 100, according to an embodiment of the present disclosure.
[9] FIG. 2 illustrates a schematic block diagram of tissue removal device 100, according to the embodiment of the present disclosure.
[10] FIG. 2A illustrates one pulse of a second motor control signal, according to an embodiment of the present disclosure.
[11] FIG. 3 illustrates an isometric view of a headpiece assembly 101, according to the embodiment of the present disclosure.
[12] FIG. 4 illustrates a sectional view of the headpiece assembly 101, according to the embodiment of the present disclosure.
[13] FIG. 5 illustrates an isometric view of a generator assembly 102, according to an embodiment of the present disclosure.
[14] FIG. 6 illustrates a cross sectional side view of the generator assembly 102, according to the embodiment of the present disclosure.
[15] FIG. 7 illustrates an exploded view of the headpiece assembly 101 of the tissue removal device 100, according to the embodiment of the present disclosure.
[16] FIG. 8 illustrate schematic views of a motor 101a of the tissue removal device 100, according to the embodiment of the present disclosure.
[17] FIG. 9 illustrate schematic views of a motor cap 8 of the tissue removal device 100, according to the embodiment of the present disclosure.
[18] FIG. 10 illustrate perspective views of a motor gear 9 of the tissue removal device 100, according to the embodiment of the present disclosure.
[19] FIGS. 11A and 11B illustrate perspective views of a rotor gear 5 of the tissue removal device 100, according to the embodiment of the present disclosure.
[20] FIG. 12A illustrates a perspective view of an inner tube assembly 4 of the tissue removal device 100, according to an embodiment of the present disclosure.
[21] FIG. 12B illustrates an exploded view of the inner tube assembly 4, according to an embodiment of the present disclosure.
[22] FIG. 12C illustrates a perspective view of a first blade 101b1 of the inner tube assembly 4, according to the embodiment of the present disclosure.
[23] FIG. 13 illustrates a perspective view of a suction tube 2 of the tissue removal device 100, according to the embodiment of the present disclosure.
[24] FIG. 14A illustrates a perspective view of an outer tube assembly 13 of the tissue removal device 100, according to the embodiment of the present disclosure.
[25] FIG. 14B illustrates an exploded view of the outer tube assembly 13, according to an embodiment of the present disclosure.
[26] FIG. 14C illustrates a perspective view of a hub 13a of the outer tube assembly 13, according to an embodiment of the present disclosure.
[27] FIG. 15 illustrates a flowchart of a method 200 of operating the tissue removal device 100 in a first mode of operation, in accordance with the embodiment of the present disclosure.
[28] FIG. 16 illustrates a flowchart of a method 300 of operating the tissue removal device 100 in a second mode of operation, in accordance with the embodiment of the present disclosure.
[29] Further, skilled artisans will appreciate that elements in the drawings are illustrated for simplicity and may not have necessarily been drawn to scale. Furthermore, in terms of the construction of the device, a plurality of components of the device may have been represented in the drawings by conventional symbols, and the drawings may show only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the drawings with details that will be readily apparent to those of ordinary skill in the art having benefit of the description herein.
DETAILED DESCRIPTION OF THE DRAWINGS
[30] 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, coupled 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.
[31] 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.
[32] 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.
[33] 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.
[34] The present disclosure relates to a tissue removal device (or device). The device is used to perform medical procedures such as cutting or removal of tissues in human body, i.e., the device is configured to remove soft or hard tissues during a surgical procedure such as, but not limited to, sinus surgery, trans-nasal skull base surgery, otology, neurotology, lateral skull base surgery, etc.
[35] Advantageously, the device of the present disclosure eliminates the cumbersome and heavy surgical devices, which poses multiple issues, such as blockages during device reuse and challenges in transporting such devices to different operating rooms due to its size. Unlike reusable devices that carry a risk of cross-contamination, the device of the present disclosure is designed for one-time use, ensuring enhanced safety. The device of the present disclosure does not require a large generator assembly, which leads to simplified usage and eliminating the necessity for a substantial initial investment. The device includes non-detachable blades, which eliminates the reusability of the device and prevents cross-contamination. The device requires minimal operating power due to compact size.
[36] Embodiments of the present disclosure will now be described below in detail with reference to the accompanying drawings.
[37] FIG. 1 illustrates a schematic view of a tissue removal device 100 (or a device 100), according to an embodiment of the present disclosure. FIG. 2 illustrates a schematic block diagram of the tissue removal device 100, according to an embodiment of the present disclosure.
[38] The device 100 includes, without limitation, a headpiece assembly 101, a generator assembly 102, a switch assembly 103 (interchangeably referred to as switching assembly 103), and an adaptor 104. The device 100 receives power through the adapter 104. The generator assembly 102 is coupled to the headpiece assembly 101 and the switch assembly 103 is coupled to the generator assembly 102. In an embodiment, the headpiece assembly 101, the generator assembly 102 and the switch assembly 103 are enclosed in a respective housing. In another embodiment, the headpiece assembly 101, the generator assembly 102 and the switch assembly 103 are enclosed together in one housing. In yet another embodiment, the headpiece assembly 101 and the generator assembly 102 are enclosed in one housing and the switch assembly 103 is enclosed in another housing.
[39] Referring now to FIG. 2, the headpiece assembly 101 is an electro-mechanical actuating component of the tissue removal device 100 (or device 100) and is configured to remove tissues during a surgical procedure. In an embodiment, the headpiece assembly 101 of the device 100 includes a motor 101a and at least one blade 101b. The at least one blade 101b is rotatably coupled to the motor 101a. Further, the at least one blade 101b is non-detachably coupled to a housing of the headpiece assembly 101. The motor 101a is configured to provide rotational motion to the at least one blade 101b. In an embodiment, the motor 101a is a servo motor. The at least one blade 101b includes a surgical blade with sharp ends and is configured to tear down tissues during a surgical procedure. The at least one blade 101b is configured to operate in a first mode or a second mode during the surgical procedure. In the first mode, the at least one blade 101b continuously rotates in a pre-defined direction (for example, clockwise or anti-clockwise). In the second mode, the at least one blade 101b alternately rotates (or oscillates) in a first pre-defined direction (e.g., clockwise) from a first pre-defined angle to a second pre-defined angle and a second pre-defined direction (e.g., anti-clockwise) from the second pre-defined angle to the first pre-defined angle. It is possible that the first pre-defined direction may be anti-clockwise and the second pre-defined direction may be clockwise. In an exemplary embodiment, the first pre-defined angle is 0 degrees and the second pre-defined angle is 180 degrees. Thus, the at least one blade 101b rotates from 0 to 180 degrees in the first pre-defined direction (say clockwise) and rotates from 180 degree to 0 degrees in the second pre-define direction (say anti-clockwise) during the second mode. The use of the first and the second mode are dependent on the type of surgical procedure. For example, in a sinus surgery, both the second mode and the first mode are employed by the surgeon as needed. The at least one blade 101b is non-detachable, which eliminates the reusability of the tissue removal device 100 and prevents cross-contamination. The headpiece assembly 101 provides a compact operating tool, which enables the user to comfortably perform the surgical procedure.
[40] The adaptor 104 is configured to provide electric power to the controller 102b for operation of the tissue removal device 100. In an example, the adaptor 104 is be configured to provide the power supply of a desired wattage (e.g., 12W) at desired voltage (e.g., 12V, 18V, 24V).
[41] The generator assembly 102 is configured to control the electric power transmission from the adaptor 104 to the headpiece assembly 101. The generator assembly 102 is coupled to the switching assembly 103 and the motor 101a. In an implementation, the generator assembly 102 includes a controller 102b, a voltage regulator 102a and a motor driver 102c coupled to the controller 102b and the motor 101a of the headpiece assembly 101. The controller 102b is coupled to the switch assembly 103. The generator assembly 102 is configured to control the motion of the at least one blade 101b during the surgical procedure.
[42] The controller 102b in the generator assembly 102 is configured to receive an electric power from a power source, for example, via the adapter 104. The controller 102b is configured to actuate the motor driver 102c to allow controlled rotation of the motor 101a. Examples of the controller 102b include, but are not limited to, a microprocessor, a microcontroller, a processor, a logic controller, an application specific integrated circuit and the like. In an example implementation, the controller 102b includes a Printed Circuit Board (PCB) having a microcontroller, a memory, a driver circuitry, and other circuitry capable for performing the functions of the controller 102b as disclosed herein. The tissue removal device 100 does not require large generator, i.e., the generator assembly 102 is compact. The design and coupling of various components of the headpiece assembly 101 allow the generator assembly 102 to be smaller compared to the conventional generators. The compact generator assembly 102 leads to simplified usage and eliminating the necessity for a substantial initial investment.
[43] The switch assembly 103 is configured to control the operation of the at least one blade 101b in the second mode and the first mode. The switch assembly 103 includes two switches, namely, a first switch 103a and a second switch 103b. The first switch 103a and the second switch 103b are configured to actuate or activate at least one mode of operation of the device 100. In an embodiment, the first switch 103a is configured to activate the first mode of operation of the device 100 and the second switch 103b is configured to activate the second mode of operation of the device 100.
[44] The generator assembly 102 and the switch assembly 103 are configured to control the operation of the headpiece assembly 101. The user presses either the first switch 103a or the second switch 103b during operation of the tissue removal device 100 while performing the surgical procedure. The pressing of the first switch 103a enables the controller 102b to operate the at least one blade 101b in the first mode of operation and the pressing of the second switch 103b enables the controller 102b to operate the at least one blade 101b in the second mode of operation. The switch assembly 103 in the tissue removal device 100 provides smooth control over different modes of operation of the tissue removal device 100.
[45] The first switch 103a and the second switch 103b may be any switching elements known in the art, such as, for example, a push button, sliding switch, pedal switch, etc. The first switch 103a and the second switch 103b may be actuated by a hand or a foot. In an embodiment, the first switch 103a and the second switch 103b are footswitches and thus, the switch assembly 103 is a footswitch assembly. This enables the user to operate the first switch 103a and the second switch 103b using a foot, keeping the hands free for holding and manipulating the headpiece assembly. In an embodiment, the switch assembly 103 includes a first pedal actuation mechanism and the second pedal actuation mechanism (not shown) coupled to the first switch 103a and the second switch 103b, respectively. The first and second pedal actuation mechanisms may be any pedal mechanisms known in the art. Though the first switch 103a and the second switch 103b are described herein as separate switches, it is possible that the first switch 103a and the second switch 103b may be two states of a two-way switch.
[46] In an operation, a user turns on a power supply from the power source to provide the electric power to the controller 102b in the generator assembly 102. Further, the user operates the switch assembly 103 to press either the second switch 103b or the first switch 103a to operate the device 100 in the second mode or the first mode as desired. Based on the actuation of the switch assembly 103, the switch assembly 103 transmits an actuation signal to the controller 102b of the generator assembly 102, which in turns drives the motor 101a to provide rotational motion to the at least one blade 101b of the headpiece assembly 101 (explained later). The at least one blade 101b performs motion in either the second mode or the first mode. The user can switch the mode of operation of the at least one blade 101b from the second mode to the first mode and vice versa through the first switch 103a and the second switch 103b.
[47] The voltage regulator 102a is an electronic device that maintains a constant output voltage from the adaptor 104 (e.g., 24V) regardless of variations in the input voltage or load conditions. The voltage regulator 102a is configured to control the electric power supply received by the controller 102b to allow controlled rotation of the motor 101a.
[48] The voltage regulator 102a plays a crucial role in maintaining a consistent power supply, ensuring the proper functioning of the controller 102b, the motor driver 102c, and ultimately the motor 101a in the headpiece assembly 101.
[49] The motor driver 102c is an electronic device or circuit that controls the movement of the motor 101a. The motor driver 102c is configured to regulate the electrical current and voltage supplied to the motor 101a, enabling precise control of the speed, direction, and other parameters of the motor 101a. The motor driver 102c provides a precise control of the motor 101a, enhancing the performance and longevity of the device 100 in various applications. The motor driver 102c may include any known circuit(s) capable of switching and modulating a power signal provided to the motor 101a under the control of the controller 102b.
[50] In operation, the voltage regulator 102a receives an input electric power from the adapter 104, and the voltage regulator 102a is configured to supply the power to the controller 102b. Further, the controller 102b receives actuation signals from the switch assembly 103 to operate the tissue removal device 100 in either the second mode or the first mode of operation. In an embodiment, the switch assembly 103 is configured to send (or interchangeably referred to as transmit) a first actuation signal and a second actuation signal. The first actuation signal and the second actuation signal are indicative of the first mode and the second mode, respectively. For example, in response to the actuation of the first switch 103a, the switch assembly 103 is configured to transmit the first actuation signal to the controller 102b, and in response to the actuation of the second switch 103b, the switch assembly 103 is configured to transmit the second actuation signal to the generator assembly 102, for example, to the controller 102b of the generator assembly 102. The switch assembly 103 sends the first actuation signal and the second actuation signal as long as the first switch 103a and the second switch 103b, respectively, are actuated, e.g., pressed.
[51] Upon receiving the actuation signal from the switch assembly 103, the controller 102b is configured to provide a respective control signal to the motor driver 102c. The control signals from the controller 102b indicate the operating mode selected by the user via the switch assembly 103. Subsequently, in response to receiving the control signal, the motor driver 102c is configured to actuate the motor 101a located in the headpiece assembly 101. For example, the motor driver 102c sends one or more motor control signals to the motor 101a to actuate the motor 101a. The motor driver 102c regulates the rotational speed, the rotational direction of the motor 101a with the help of the one or more motor control signals to actuate the motor 101a as per the operating mode. In an embodiment, each of the one or more control signals includes a Pulse Width Modulation (PWM) signal. The motor driver 102c adjusts one or more of: a frequency, a duty cycle, a pulse width, a polarity of the PWM signal based upon the control signals received from the controller 102b. The motor 101a further actuates the at least one blade 101b to remove tissues from the surgical site during the surgical procedure.
[52] Upon receiving the actuation signals from the switch assembly 103, the generator assembly 102 is configured to actuate the motor 101a as per the operating mode. In an embodiment, the generator assembly 102 is configured to send a first motor control signal to the motor 101a to rotate the motor 101a in the first mode in response to receipt of the first actuation signal and send a second motor control signal to the motor 101a to rotate the motor 101a in the second mode in response to receipt of the second actuation signal. The controller 102b is configured to receive the first actuation signal and the second actuation signal. According to an embodiment, in response to receipt of the first actuation signal from the switch assembly 103, the controller 102b is configured to send a first control signal to the motor driver 102c. The first control signal is indicative of the first mode. The motor driver 102c is configured to receive the first control signal. In response to receipt of the first control signal from the controller 102b, the motor driver 102c is configured to send the first motor control signal to the motor 101a to rotate the motor 101a in the first mode. The first motor control signal causes the motor 101a to rotate according to the first mode. In the first mode, motor 101a continuously rotate in the pre-defined direction (for example, clockwise or anti-clockwise). In an embodiment, the first motor control signal is a first PWM signal having a 100% duty cycle. The first PWM signal has a pre-defined voltage according to the rating of the motor 101a and a polarity according to the pre-defined direction. For example, the first PWM signal has a positive polarity to rotate the motor 101a in the clockwise direction or a negative polarity to rotate the motor 101a in the anti-clockwise direction. The first motor control signal may be sent for a duration of the first actuation signal (and, the first control signal is received), which in turn corresponds to the duration for which the first switch 103a is actuated (e.g., pressed). In an embodiment, the first motor control signal may be sent for a maximum duration of, say, 3 minutes, followed by a signal of zero voltage for an OFF duration, say, 3 minutes. As a result, the motor 101a is allowed to run continuously only for the maximum duration followed by the OFF duration, when the motor 101a does not run. This is done to prevent overheating the motor 101a and other components. The maximum duration and the OFF duration may be set based upon the rating of the motor 101a and the ambient temperature.
[53] Similarly, in an embodiment, in response to receipt of the second actuation signal from the switch assembly 103, the controller 102b is configured to send a second control signal to the motor driver 102c. The second control signal is indicative of the second mode. The motor driver 102c is configured to receive the second control signal. In response to receipt of the second control signal from the controller 102b, the motor driver 102c is configured to send the second motor control signal to the motor 101a to rotate the motor 101a in the second mode. The second motor control signal causes the motor 101a to rotate according to the second mode. In other words, in the second mode, the motor 101a rotates alternately in a first pre-defined direction from the first pre-defined angle to the second pre-defined angle and in a second direction from the second pre-defined angle to the first pre-defined angle. In the second mode, the at least one blade 101b alternately rotates (or oscillates) in the first pre-defined direction (e.g., clockwise) from the first pre-defined angle to the second pre-defined angle and in the second pre-defined direction (e.g., anti-clockwise) from the second pre-defined angle to the first pre-defined angle. For example, the motor 101a rotates from 0 to 180 degrees in the clockwise direction and rotates from 180 degrees to 0 degrees in the anti-clockwise direction during the second mode.
[54] In an embodiment, the second motor control signal includes a second pulse wave signal having a plurality of pulses, with a predefined duty cycle ranging from 40% to 60%. In an embodiment, the predefined duty cycle is 50%. In each pulse, the second pulse wave signal alternates between a positive signal and a negative signal, causing the motor 101a to rotate in the clockwise and anti-clockwise in an oscillatory motion as per the second mode. Thus, in a single cycle the motor 101a first rotates in clockwise direction and then rotates in an anti-clockwise direction for a predefined time. Fig. 2a depicts one pulse of the second motor control signal. In an embodiment, each pulse includes a first phase, a second phase, a third phase and a fourth phase. The first phase extends from ‘t1’ to ‘t2’ and includes a positive signal of a pre-defined voltage for a first time period T1. The pre-defined voltage is chosen based upon the rating of the motor 101a. T1 may range between 190 ms to 210 ms. In an exemplary embodiment, T1 is 200 ms. The first phase is configured to rotate the motor 101a in the clockwise direction. The second phase follows the first phase. The second phase extends from ‘t2’ to ‘t3’, and includes a first guard signal with zero voltage for a second time period T2. T2 may range from 90 ms to 110 ms. In an exemplary embodiment, T2 is 100 ms. The second phase is configured to stop the rotation of the motor 101a, after its rotation in clockwise direction. The third phase follows the second phase. The third phase extends from ‘t3’ to ‘t4’, and includes a negative signal of the pre-defined voltage for a third time period T3. T3 may range from 190 ms to 210 ms. In an exemplary embodiment, T3 is 200 ms. The third phase is configured to rotate the motor 101a in anti-clockwise direction. The fourth phase follows the third phase. Further, the fourth phase extends from ‘t4’ to ‘t5’, and includes a second guard signal with zero voltage for fourth time period T4. T4 may range between 90 ms to 110 ms. In an exemplary embodiment, T4 is 100 ms. The fourth phase of the first cycle is configured to stop the rotation of the motor 101a, after its rotation in anti-clockwise direction. The second and fourth phase of the pulse is configured to provide a time gap between changing the rotational direction of the motor 101a from clockwise to anti-clockwise, or vice-versa. Due to these phases, the motor 101a gradually slows down before changing the rotational direction. This avoids sudden changes in the rotational direction, thereby preventing jerks in the motor 101a and reducing vibrations in the headpiece assembly. It is to be noted, the values for T1 – T4 described herein are merely exemplary and should not be considered as limiting. Other values of T1 – T4 may be chosen based upon the requirements of the surgical procedure. It is possible that, in another embodiment, the second motor control signal may include a square wave having alternate positive signal (similar to the first phase described above) and negative signal (similar to the third phase described above) without the first guard signal and the second guard signal in between. In this case, the duty cycle is 50%.
[55] FIG. 3 illustrates an isometric view of the headpiece assembly 101 and FIG. 4 illustrates a sectional view of the headpiece assembly 101, according to the embodiment of the present disclosure.
[56] The headpiece assembly 101 includes a first housing 1 configured to enclose components of the headpiece assembly 101. The first housing 1 also provides support to the components of the headpiece assembly 101. In an example, the first housing 1 is a metallic housing. In another example, the first housing 1 is a non-metallic housing. The user operating the tissue removal device 100 holds the headpiece assembly 101 by gripping the first housing 1. In an embodiment, the first housing 1 is compact, which makes it suitable to be held by hands of an operating person.
[57] The headpiece assembly 101 includes the at least one blade 101b coupled at a distal end 1c of the first housing 1 and a power cable 3 coupled at a proximal end 1d of the first housing 1. The power cable 3 is an electrical cable and is configured to transmit electric power supply and the motor control signals from the generator assembly 102 to the motor 101a. In an implementation, the power cable 3 includes one or more conductors made of copper or aluminum wires encased in an insulating material.
[58] Further, the headpiece assembly 101 of the device 100 includes a suction tube 2 coupled to the proximal end 1d of the first housing 1 (adjacent to the power cable 3) as shown in FIG. 3. The suction tube 2 is coupled to the first housing 1 such that the suction tube 2 does not rotate. The suction tube 2 is a hollow tube and is configured to provide a passage for unwanted material from a surgical site during the surgical procedure.
[59] With reference to FIG. 4, the headpiece assembly 101 includes an inner tube assembly 4 and an outer tube assembly 13. The inner tube assembly 4 is at least partially disposed within the outer tube assembly 13. The inner tube assembly 4 is configured to rotate in response to the rotation of the motor 101a. According to an embodiment, the at least one blade 101b includes a first blade 101b1 and a second blade 101b2. The inner tube assembly 4 includes the first blade 101b1 and the outer tube assembly 13 includes the second blade 101b2.
[60] Further, the headpiece assembly 101 includes a rotor gear 5 coupled to the inner tube assembly 4. The rotor gear 5 is configured to transmit rotational motion from the motor 101a to the at least one blade 101b through the inner tube assembly 4.
[61] Further, the headpiece assembly 101 includes a motor gear 9 engaged with the rotor gear 5. The motor 101a is coupled to the motor gear 9. The motor gear 9 and the rotor gear 5 are in constant mesh with each other. The motor gear 9 is configured to transmit rotational motion from the motor 101a to the rotor gear 5.
[62] Further, the headpiece assembly 101 includes a motor cap 8 configured to cover the motor 101a at a distal end of the motor 101a. The motor cap 8 provides support and protects components of the motor 101a.
[63] Further, the headpiece assembly 101 of the device 100 includes a plurality of washers (e.g., washers 7a, 7b, 7c) coupled to the motor 101a. The plurality of washers helps in reducing the vibration of the motor 101a. In an embodiment, the plurality of washers includes a first washer 7a, a second washer 7b and a third washer 7c. The washers 7a, 7b, 7c are configured to distribute the force exerted by the motor 101a due to vibration. The washers 7a, 7b, 7c may be a flat, thin, and ring made of a suitable material. In an example, the washers 7a, 7b, 7c are metallic washers. In another example, the washers 7a, 7b, 7c are non-metallic washers. The first washer 7a, the second washer 7b, and the third washer 7c reduce vibrations during the operation. The first washer 7a, the second washer 7b and the third washer 7c are positioned within a respective bracket of the first housing 1. In an example implementation, the first washer 7a, the second washer 7b and the third washer 7c are positioned over the circumference of the motor 101a (as shown in FIG. 4). The third washer 7c is provided towards the distal end of the motor 101a and may contact the motor cap 8. The second washer 7b is provided at a suitable position along the length of the motor 101a, e.g., at a mid-point of the length of the motor 101a. The first washer 7a is provided at a proximal end of the motor 101a. Furthermore, the first washer 7a, the second washer 7b and the third washer 7c are placed coaxially and may be equidistant from each other.
[64] The motor 101a, the motor cap 8, the motor gear 9, the rotor gear 5 are disposed in the first housing 1. The inner tube assembly 4, the outer tube assembly 13 and the suction tube 2 are partially disposed inside and partially disposed outside the first housing 1. Further, once the first housing 1 is assembled, the inner tube assembly 4, the outer tube assembly 13 and the suction tube 2 are non-detachable from the first housing 1. Thus, the headpiece assembly 101 is configured for one-time use, thereby minimizing the chances of contamination and improving patient safety.
[65] In operation, the motor 101a in the headpiece assembly 101 receives the power supply from the generator assembly 102 through the power cable 3. In an implementation, the power cable 3 includes three or more connectors provided at a distal end of the power cable 3. A first connector and a second connector of the three or more connectors are coupled to a positive and a negative power input terminal, respectively, of the motor 101a. A third connector of the three or more connectors is coupled to a control input terminal. The first and second connectors carry the power signals from the voltage regulator 102a and the third connector carries the motor control signals from the motor driver 102c. The motor 101a rotates according to the power signals and the motor control signals. The motor 101a transmits the rotational motion to the motor gear 9 via a shaft (e.g., a motor shaft 101c). Further, the motor gear 9 rotates the rotor gear 5. Examples of the rotor gear 5 and the motor gear 9 may include, but are not limited to, a spur gear, a single helical gear, a double helical gear and the like. Furthermore, the rotor gear 5 rotates the at least one blade 101b through the inner tube assembly 4 to perform the surgical procedure.
[66] FIG. 5 illustrates an isometric view and FIG. 6 illustrates a cross sectional side view of the generator assembly 102, according to the embodiment of the present disclosure.
[67] In an embodiment, the generator assembly 102 includes a casing 10. The casing 10 is configured to enclose and support various components of the generator assembly 102. In an implementation, the casing 10 is a metallic casing covered with a non-metallic insulator. Further, one end of the power cable 3 is coupled to the controller 102b through the casing 10.
[68] The generator assembly 102 includes a cable 11. One end of the cable 11 is coupled to the controller 102b through the casing 10 and the other end (not shown) of the cable 11 is coupled to the adaptor 104. The cable 11 is configured to provide the power supply from the adaptor 104 to the controller 102b, and the motor driver 102c.
[69] Further, the generator assembly 102 includes a connector 12 configured to couple the generator assembly 102 with the switch assembly 103. The connector 12 is configured to provide an electrical connection for the actuation signals received from the switch assembly 103 to the controller 102b. The actuation signals from the switch assembly 103 indicates which of the first switch 103a or the second switch 103b has been pressed, as described earlier. According to an embodiment, the generator assembly 102 includes a PCB 102d. The PCB 102d includes circuitry corresponding to the voltage regulator 102a, the controller 102b and the motor driver 102c. In an example implementation, the controller 102b and the motor driver 102c are provided in a single integrated circuit (IC).
[70] In operation, the adaptor 104 supplies electric power to the controller 102b through the cable 11. Further, the controller 102b is configured to transmit the control signals to the motor driver 102c (e.g., via an internal bus of the IC), which in turn transmits the motor control signals to the motor 101a through the power cable 3.
[71] FIG. 7 illustrates an exploded view of the headpiece assembly 101 of the tissue removal device 100, according to the embodiment of the present disclosure. The headpiece assembly 101 includes a first sub-housing 1a and a second sub-housing 1b, which when coupled together form the first housing 1. Further, the headpiece assembly 101 includes the motor gear 9, the motor cap 8, the motor 101a, the inner tube assembly 4, the rotor gear 5, the suction tube 2, the washers 7a, 7b, 7c. The first sub-housing 1a and the second sub-housing 1b have suitable supporting structures and cut-outs to support and receive various components of the headpiece assembly 101 as illustrated in subsequent figures.
[72] In an embodiment, the first sub-housing 1a includes a plurality of embedded or engraved structures acting as a chassis and providing support to various components of the headpiece assembly 101. In an embodiment, the plurality of support structure (which may be embedded or engraved) may include one or more of: cutouts, walls, sockets, rails, brackets, kerf, etc. The second sub- housing 1b is may be a mirror image of the first sub-housing 1a and hence, is not described separately for brevity.
[73] FIG. 8 illustrate schematic views of the motor 101a of the tissue removal device 100, according to the embodiment of the present disclosure. The motor 101a is disposed within and coupled to the first housing 1. The motor 101a is configure to rotate. The motor 101a is coupled to the motor gear 9. The motor 101a rotates in response to receiving the power signal and the motor control signal (e.g., the first motor control signal and the second motor signal) received through the power cable 3. The motor 101a rotates based upon the motor control signal as explained herein. The motor 101a includes a motor shaft 101c extending in a distal direction. The motor shaft 101c of the motor 101a rotates in response to the rotation of the motor 101a during operation of the tissue removal device 100. In an embodiment, the motor shaft 101c is D-shaped, though it may have any other shape. The motor 101a is configured to transmit rotational motion to the motor gear 9 through the motor shaft 101c. At a distal end, the motor 101a includes a plurality of aperture 101a1. The plurality of apertures 101a1 of the motor 101a receives a plurality of rivets 14 coupling the motor 101a and the motor cap 8.
[74] The motor 101a is configured to rotate in a clockwise and an anticlockwise direction based upon first motor control signal and the second motor control signal. The motor 101a may rotate at a pre-defined rotational speed. The pre-defined rotational speed may be chosen based upon the requirements of the surgical procedure. In an embodiment, the pre-defined rotational speed may range between 2500 RPM and 3000 RPM. In an example implementation, the pre-defined rotational speed is 3000 RPM. The pre-defined rotational speed may be pre-set or may be varied during the operation of the tissue removal device 100 as needed. The controller 102b may control the pre-defined rotational speed of the motor 101a.
[75] FIG. 9 illustrates a schematic view of the motor cap 8 of the tissue removal device 100, according to the embodiment of the present disclosure. The motor cap 8 is coupled to the motor 101a at the distal end of the motor 101a. The motor cap 8 includes a slot 8a. The slot 8a may be provided centrally. The slot 8a is configured to provide passage to the motor shaft 101c. The motor shaft 101c passes through the slot 8a. The motor cap 8 may be a metallic cap or a non-metallic cap. The motor cap 8 covers the distal end of the motor 101a. The cross-sectional shape and dimensions of the motor cap 8 corresponds to the cross-sectional shape and dimension of the distal end of the motor 101a. The motor cap 8 is coupled to the motor 101a using a coupling mechanism, such as, slot-fit, press-fit, riveting, etc. In an example implementation, the motor cap 8 is riveted to the motor 101a. The motor cap 8 includes a plurality of apertures 8b. The plurality of aperture 8b of the motor cap 8 are aligned with the plurality of apertures 101a1 of the motor 101a and are configured to receive a respective one of the plurality of rivets 14 riveting the motor cap 8 and the motor 101a. The motor cap 8 provides vibrational damping to the motor 101a during the second mode.
[76] FIG. 10 illustrates a perspective view of the motor gear 9 of the device 100, according to the embodiment of the present disclosure. The motor gear 9 is disposed within and coupled to the first housing 1. The motor gear 9 is disposed distal to the motor 101a and is rotatably coupled to the motor shaft 101c of the motor 101a. The motor gear 9 is configured to rotate in response to the rotation of the motor 101a and the motor shaft 101c. The motor gear 9 is configured to transmit the rotational motion from the motor 101a to the rotor gear 5 and thence, to the at least one blade 101b. The motor gear 9 includes a first shaft 9b and a first gearwheel 9a coupled axially to the first shaft 9b. The first shaft 9b extends in a proximal direction. In an embodiment, the first gearwheel 9a has a cavity (not shown) configured to receive and couple with the first shaft 9b, coupling the first shaft 9b and the first gearwheel 9a. The first shaft 9b of the motor gear 9 is rotatably coupled to the motor shaft 101c of the motor 101a. The first shaft 9b includes a cavity 9c configured to receive and couple with the motor shaft 101c. The cavity 9c is designed corresponding to the motor shaft 101c. The first gearwheel 9a includes a plurality of teeth 9d. The plurality of teeth 9d are responsible for the transfer of the rotating motion to the rotor gear 5. The first gearwheel 9a and the first shaft 9b are configured to rotate in response to the rotation of the motor 101a and the motor shaft 101c.
[77] FIGS. 11A and 11B illustrate perspective views of the rotor gear 5 of the tissue removal device 100, according to the embodiment of the present disclosure. The rotor gear 5 is rotatably coupled to the motor gear 9 and is configured to rotate in response to the rotation of the motor gear 9. The rotor gear 5 is in constant mesh with the motor gear 9. The rotor gear 5 is further coupled to the inner tube assembly 4. In an embodiment, the rotor gear 5 includes a second shaft 5a and a second gearwheel 5b coupled coaxially with the second shaft 5a. The second gearwheel 5b includes a hole (not shown) configured to receive and couple with the second shaft 5a, i.e., the second shaft 5a is coaxially disposed within the second gearwheel 5b. A proximal end of the second shaft 5a extends proximally from the second gearwheel 5b and a distal end of the second shaft 5a extends distally from the second gearwheel 5b. The second shaft 5a is hollow, having a cavity 5e extending for the length of the second shaft 5a. A proximal end of the second shaft 5a is coupled to the suction tube 2 using any coupling mechanism such as, but not limited to, press-fit, slot-fit, riveting, etc. In an embodiment, the second shaft 5a and the suction tube 2 are press fitted together. The unwanted material removed during the surgical site is transferred to the suction tube 2 through the cavity 5e of the second shaft 5a. The second shaft 5a includes a pair of wings 5c provided at a distal end of the second shaft 5a. The pair of wings 5c are disposed on opposite sides of the distal end of the second shaft 5a. The pair of wings 5c are used to couple the second shaft 5a to the inner tube assembly 4. The second gearwheel 5b of the rotor gear 5 includes a plurality of teeth 5d configured to engage with the teeth 9d of the motor gear 9. The engagement between the teeth 5d and the teeth 9d is responsible for the transfer of the rotating motion between the motor gear 9 and the rotor gear 5. In other words, the second shaft 5a and the second gearwheel 5b are configured to rotate in response to the rotation of the first shaft 9b and the first gearwheel 9a (or the rotation of the motor 101a).
[78] FIG. 12A illustrates a perspective view of the inner tube assembly 4 of the tissue removal device 100 and FIG. 12B illustrates an exploded view of the inner tube assembly 4, according to the embodiment of the present disclosure. The inner tube assembly 4 may be made from a bio-compatible material, such as, but not limited to, stainless steel, cobalt-chromium, titanium, tantalum, Polyether ether ketone (PEEK), Polytetrafluoroethylene (PTFE), Acrylonitrile Butadiene Styrene (ABS), polycarbonate, etc. In an embodiment, the inner tube assembly 4 is made from stainless steel. The inner tube assembly 4 is coupled to the first housing 1 at the distal end 1c of the first housing 1. The inner tube assembly 4 is coupled to the rotor gear 5. The inner tube assembly 4 includes a first blade 101b1 provided at a distal end of the inner tube assembly 4. The first blade 101b1 forms one jaw of the at least one blade 101b. The first blade 101b1 includes a plurality of first teeth 101d1 (as shown in Fig. 12C). The inner tube assembly 4 is configured transmit the rotational motion received from the rotor gear 5 to the first blade 101b1 during operation of the device 100. The first blade 101b1 is made from a bio-compatible material such as, without limitation, stainless steel, cobalt-chromium, titanium, tantalum, etc. In an embodiment, the first blade 101b1 is made from stainless steel. The first blade 101b1 has a tubular structure, defining a cavity 101c1. In an embodiment, the inner tube assembly 4 includes an inner shaft 4a rotatably coupled to the rotor gear, e.g., to the second shaft 5a of the rotor gear 5 at a proximal end of the inner shaft 4a. The inner shaft 4a has the first blade 101b1 at a distal end of the inner shaft 4a. In an embodiment, the inner shaft 4a and the first blade 101b1 may form an integrated structure, i.e., they are integrally coupled. It is possible though that the inner shaft 4a and the first blade 101b1 are separate components fixedly coupled using any suitable technique. The inner shaft 4a is partially disposed outside the first housing 1 and partially disposed inside the first housing 1. Further, once the housing 1 is assembled, the inner shaft 4a and the first blade 101b1 are non-detachable from the first housing 1. The inner shaft 4a is configured to transmit the rotational motion received from the rotor gear 5 to the first blade 101b1. The inner shaft 4a is rotatably coupled to the rotor gear 5 and is configured to rotate in response to the rotation of the rotor gear 5. In an embodiment, a proximal end of the inner shaft 4a is disposed within and coupled to the cavity 5e of the second shaft 5a. In other words, the cavity 5e of the second shaft 5a is configured to receive and couple with a proximal end of the inner shaft 4a using, for example, a press-fit mechanism. The second shaft 5a is configured to rotate the inner shaft 4a and the first blade 101b1, in response to the rotation of the motor 101a.The inner shaft 4a is hollow, having a lumen (not shown) providing a passage to the unwanted material or the tissue extracted during the operation of the device 100. The lumen of the inner shaft 4a is aligned with the cavity 101c1 of the first blade 101b1. The inner tube assembly 4 further includes an enclosure 4b enclosing a proximal portion of the inner shaft 4a, and coupled to the first housing 1. The enclosure 4b has a tubular structure having one or more protrusions 4b2 on its outer surface towards a distal end of the enclosure 4b. The plurality of protrusions 4b2 are coupled to the first housing 1 (as depicted in FIG. 12C) and provides support to the inner shaft 4a within the first housing 1. The protrusions 4b2 are coupled to the first housing 1 such that the inner tube assembly 4 is able to rotate. A proximal end of the enclosure 4b includes a pair of slots 4b1 extending from a proximal end towards a distal end of the enclosure 4b. In an embodiment, each of the plurality of slots 4b1 is configured to receive a corresponding wing 5c of the wings 5c of the second shaft 5a. The plurality of slots 4b1 are designed such that they correspond to the wings 5c coupling the rotor gear 5 and are coupled via a press-fit coupling technique. The coupling between the wings 5c and the plurality of slots 4b1 facilitates the rotation of the enclosure 4b in response to the rotation of the second shaft 5a. Thus, the entire inner tube assembly 4 is configured to rotate in response to the rotation of the motor 101a. It is possible that the enclosure 4b and the rotor gear 5 are coupled using other coupling techniques known in the art. The inner tube assembly 4 includes a spring 4c and a washer 4d provided within the enclosure 4b. The spring 4c is disposed over the inner shaft 4a. The washer 4d is provided at a proximal end of the enclosure 4b and abuts a distal end of the second shaft 5a of the rotor gear 5. The spring 4c and the washer 4d is provided to compensate the vibration in the rotor gear 5.
[79] In an embodiment, due to the rotatable coupling between the shaft inner 4a of the inner tube assembly 4 and the rotor gear 5, the inner shaft 4a and the first blade 101b1 are configured to rotate in response to the rotation of the rotor gear 5 (or in response to the rotation of the motor gear 9 and the motor 101a). The inner shaft 4a and the first blade 101b1 rotate in the same direction as that of the rotor gear 5 (and of the motor gear 9 and the motor 101a). In an embodiment, various components of the inner tube assembly 4 are integrally coupled as shown herein. It is possible however, that the said components are separate and coupled together using any suitable technique.
[80] FIG. 13 illustrates a perspective view of the suction tube 2 of the tissue removal device 100, according to the embodiment of the present disclosure. The suction tube 2 includes a passage 2d extending for the entire length of the suction tube 2. The passage 2d provides a channel for the unwanted material or tissues extracted by the at least one blade 101b during the surgical procedure to be sucked out from the device 100. A distal portion 2a of the suction tube 2 is disposed within the first housing 1 and a proximal portion 2b of the suction tube 2 extends out of the first housing 1. A distal end of the suction tube 2 is press-fitted to the proximal end of the second shaft 5a. In an embodiment, a coupling portion 2e, provided at the distal end of the suction tube 2, is configured to receive a proximal portion of the second shaft 5a of the rotor gear 5. The suction tube 2 includes a ring 2c provided proximal to the coupling portion 2e. The ring 2c is configured to mate with a corresponding support structure of the first sub-housing 1a and the second sub-housing 1b. The ring 2c is configured to engage with a corresponding slot in the first housing 1, securely coupling the suction tube 2 with the first housing 1. The suction tube 2 is configured to couple with a suction device (not shown), which is capable of generating a suction force to remove tissue fragments generated during the surgical procedure. The passage 2d of the suction tube 2, the cavity 5e of the second shaft 5a, the lumen of the inner shaft 4a and the cavity 101c1 of the first blade 101b1 are configured to provide a passage for tissue fragments. The passage 2d of the suction tube 2, the cavity 5e of the second shaft 5a, the lumen of the inner shaft 4a and the cavity 101c1 of the first blade 101b1 are aligned with each other so that the tissue fragments can pass through with minimal obstruction.
[81] FIGS. 14A and 14B depicts a perspective view and an exploded view of the outer tube assembly 13 of the tissue removal device 100, according to the embodiment of the present disclosure. The outer tube assembly 13 is coupled to the first housing 1. The outer tube assembly 13 may be made from a bio-compatible material, such as, but not limited to, stainless steel, cobalt-chromium, titanium, tantalum, etc. In an embodiment, the outer tube assembly 13 is made of stainless steel. The inner tube assembly 4 is coupled to the outer tube assembly 13. The outer tube assembly 13 includes an outer shaft 13e having a second blade 101b2 provided at a distal end of the outer shaft 13e of the outer tube assembly 13. Though the outer shaft 13e and the second blade 101b2 have been described herein as integrally coupled, it is possible that the outer shaft 13e and the second blade 101b2 may be separate components fixedly coupled together using any suitable coupling technique. The second blade 101b2 forms the other jaw of the at least one blade 101b. The second blade 101b2 has a plurality of second teeth 101d2 at its distal end. The second blade 101b2 is made from a bio-compatible material such as, without limitation, stainless steel, cobalt-chromium, titanium, tantalum, etc. In an embodiment, the second blade 101b2 is made from stainless steel. The outer shaft 13e is configured to receive the inner shaft 4a. In an embodiment, the outer shaft 13e has a tubular structure having a lumen (not shown) configured to receive the inner shaft 4a such that the first blade 101b1 is disposed outside of the lumen of the outer shaft 13e. The first teeth 101d1 of the first blade 101b1 and the second teeth 101d2 of the second blade 101b2 are aligned with each other. The lumen of the outer shaft 13e is designed such that the inner shaft 4a is free to rotate within the outer shaft 13e. The outer tube assembly 13 further includes a hub 13a provided at a proximal end of the outer tube assembly 13. The hub 13a is coupled to the first housing 1. The hub 13a is disposed distally to the enclosure 4b. The hub 13a has a tubular structure defining a passage 13a1 (shown in FIG. 14C) and encloses a proximal portion of the outer shaft 13e. In other words, the passage 13a1 of the hub 13a is configured to receive the proximal portion of the outer shaft 13e. The hub 13a may be generally cylindrical having a uniform or tapered diameter. In an embodiment, the hub 13a is distally tapered with its diameter reducing from a proximal end to a distal end of the hub 13a. Further, at the proximal end, the hub 13a includes a hoop 13a2 (shown in FIG. 4C) configured to fit within a corresponding slot (not shown) provided at the distal end 1c of the first housing 1 such that the outer shaft 13e of the outer tube assembly 13 is partially disposed in the first housing 1 and partially outside the first housing 1, and that the outer shaft 13e and the second blade 101b2 are non-detachable from the first housing 1. The hub 13a includes a port 13b configured to provide a passage to a saline solution during the medical procedure. Further, the outer tube assembly 13 includes a washer 13c and a sealing member 13d. The washer 13c and the sealing member 13d are disposed within the passage 13a1 towards the proximal end of the hub 13a. The sealing member 13d is disposed at the proximal end of the passage 13a1. A proximal disc of the sealing member 13d is disposed outside the hub 13a and a distal disc of the sealing member 13d is disposed inside the passage 13a1. A lumen (not shown) of the sealing member 13d provides a passage for the inner shaft 4a of the inner tube assembly 4. The sealing member 13d prevents leakage of the saline solution into other components within the first housing 1. The washer 13c is positioned distal to the sealing member 13d. The washer 13c reduces vibrations of the outer shaft 13e and the second blade 101b2. The washer 13c is provided around the inner shaft 4a. In an embodiment, the hub 13a, the outer shaft 13e, the second blade 101b2, the washer 13c and the sealing member 13d are integrally coupled as disclosed herein. It is possible though that they are separate components coupled together using a suitable coupling technique.
[82] During the procedure, the outer tube assembly 13 remains stationary, i.e., is not rotatable. Consequently, the second blade 101b2 of the outer tube assembly 13 is configured to remain stationary. The inner shaft 4a of the inner tube assembly 4 rotates inside the lumen of the outer shaft 13e and the passage 13a1 of the hub 13a. The first blade 101b1 is configured to rotate relative to the second blade 101b2. The relative movements of the first blade 101b1 and the second blade 101b2 due to the rotation of the first blade 101b1, facilitates cutting the tissue via the first teeth 101d1 and the second teeth 101d2.
[83] FIG. 15 illustrates a flowchart of a method 200 of operating the device 100 in a first mode of operation, in accordance with the embodiment of the present disclosure.
[84] At step 202, the generator assembly 102 receives a power supply from the adaptor 104. The adaptor 104 is configured to receive the power supply from a power source and transmit the power supply to the generator assembly 102. The adaptor 104 is configured to provide power supply to the voltage regulator 102a of the generator assembly 102 and the voltage regulator 102a transmits controlled power supply to the controller 102b.
[85] At step 204, a user actuates the first switch 103a of the switch assembly 103 to operate the tissue removal device 100 in the first mode of operation. In an example implementation, the user may need to press the first switch 103a continuously to operate the tissue removal device 100 in the first mode.
[86] At step 206, the switch assembly 103 sends the first actuation signal to the generator assembly 102. The first actuation signal indicates that the first switch 103a has been actuated. In an embodiment, the switch assembly 103 transmits the first actuation signal to the controller 102b of the generator assembly 102.
[87] At step 208, the generator assembly 102 transmits the first motor control signal to the motor 101a in response to receiving the first actuation signal from the switch assembly 103. In an embodiment, the controller 102b of the generator assembly 102 receives the first actuation signal and generates the first control signal. The first control signal indicates the first mode of operation. The controller 102b sends the first control signal to the motor driver 102c. Upon receiving the first control signal, the motor driver 102c generates the first motor control signal and sends the first motor control signal to the motor 101a to actuate the motor 101a in the first mode.
[88] At step 210, the motor 101a actuates the at least one blade 101b in the first mode in response to receiving the first motor control signal. As explained earlier, in the first mode, the motor 101a continuously rotates in the pre-defined direction (e.g., clockwise). In response to receiving the first motor control signal, the motor 101a causes the motor shaft 101c to rotate in the pre-defined direction. Due to the coupling of the motor gear 9 with the motor shaft 101c and the coupling of the rotor gear 5 with the motor gear 9, the second shaft 5a too rotates in the pre-defined direction. Consequently, the inner shaft 4a of the inner tube assembly 4 rotates within the second shaft 5a of the outer tube assembly 13, and the first blade 101b1 rotates continuously in the pre-defined direction. The user puts the first blade 101b1 and the second blade 101b2 in contact with the surgical site and performs tissue removal operation. The relative rotation of the first blade 101b1 with respect to the second blade 101b2 causes the first teeth 101d1 and the second teeth 101d2 to break the tissue.
[89] FIG. 16 illustrates a flowchart of a method 300 of operating the device 100 in a second mode of operation, in accordance with the embodiment of the present disclosure. In the second mode of operation of the tissue removal device 100, the motor 101a alternately rotates in the first pre-defined direction and the second pre-defined direction, which is opposite to the first pre-defined direction. For example, in the second mode, the motor 101a alternately rotates in a clockwise direction up to 180 degrees and in an anti-clockwise direction up to 180 degrees.
[90] At step 302, the generator assembly 102 receives a power supply from the adaptor 104. The adaptor 104 is configured to receive the power supply from a power source and transmit the power supply to the generator assembly 102. The adaptor 104 is configured to provide power supply to the voltage regulator 102a of the generator assembly 102 and the voltage regulator 102a transmits controlled power supply to the controller 102b.
[91] At step 304, a user actuates the second switch 103b of the switch assembly 103 to operate the tissue removal device 100 in the second mode of operation. In an example implementation, the user may need to press the second switch 103b continuously to operate the tissue removal device 100 in the second mode.
[92] At step 306, the switch assembly 103 transmits a second control signal to the generator assembly 102. The second actuation signal indicates that the second switch 103b has been actuated. The switch assembly 103 transmits the second actuation signal to the controller 102b of the generator assembly 102.
[93] At step 308, the generator assembly 102 transmits a second motor control signal to the motor 101a in response to receiving the second actuation signal. In an embodiment, the controller 102b of the generator assembly 102 receives the second actuation signal and generates the second control signal. The second control signal indicates the second mode of operation. The controller 102b sends the second control signal to the motor driver 102c. Upon receiving the second control signal, the motor driver 102c generates the second motor control signal and sends the second motor control signal to the motor 101a to actuate the motor 101a in the second mode.
[94] At step 310, the motor 101a actuates the at least one blade 101b in the second mode of operation in response to receiving the second motor control signal. As explained earlier, in the second mode, the motor 101a rotates alternately in the first pre-defined and the second pre-defined direction. According to an embodiment, in response to receiving the second motor control signal, the motor 101a causes the motor shaft 101c to rotate alternately in the clockwise direction from 0 degrees to 180 degrees and then in anticlockwise direction from 180 degrees to 0 degrees. Due to the coupling of the motor gear 9 with the motor shaft 101c and the coupling of the rotor gear 5 with the motor gear 9, the second shaft 5a too rotates in a similar manner. Consequently, the inner shaft 4a rotates alternately in the clockwise and anticlockwise direction within the outer shaft 13e and the first blade 101b1 too rotates alternately in the clockwise and anti-clockwise direction. The user puts the first blade 101b1 and the second blade 101b2 in contact with the surgical site and perform tissue removal operation. The relative rotation of the first blade 101b1 with respect to the second blade 101b2 causes the first teeth 101d1 and the second teeth 101d2 to break the tissue. According to an embodiment, the second motor control signal is designed so as to avoid excessive vibrations in the motor 101a and other components of the headpiece assembly 101 during the second mode as described earlier in conjunction with FIG. 2A.
[95] FIG. 17 illustrates a flowchart of a method 400 of using the tissue removal device 100 to break diseased tissues in a sinus surgery, according to an embodiment. Though the method 400 has been explained in the context of removing diseased tissues in a sinus surgery, it should not be considered as limiting. A similar method may be employed to remove diseased tissues using the tissue removal device 100 in other surgical procedures.
[96] At step 402, the tissue removal device 100 is set up for the surgical procedure. In an embodiment, to set up the tissue removal device 100, a power supply (e.g., AC mains supply) is coupled to the adaptor 104 and a suction device is coupled to the suction tube 2.
[97] At step 404, the distal end of the at least one blade 101b of the headpiece assembly 101 is inserted through a desired entry point (e.g., nostril, oral cavity or a small surgical incision) of a patient.
[98] At step 406, the tissue removal device 100 is activated in a desired mode of operation using the switch assembly 103. For example, the user presses the first switch 103a to operate the tissue removal device 100 in the first mode. Similarly, the user presses the second switch 103b to operate the tissue removal device 100 in the second mode. The at least one blade 101b breaks the diseased tissue into multiple fragments. The user may switch between the first mode and the second mode as desired based upon surgical requirements. For example, the second mode is used for tissue removal and the first mode is used mode for cleaning and finishing purpose. The suction device may be activated prior to or upon operating the tissue removal device 100 in the desired mode to aspirate fragments of the diseased tissues and/or unwanted material from the surgical site.
[99] At step 408, the tissue removal device 100 is deactivated, for example, by switching off the power source or by decoupling the power source from the actuator 104. The at least one blade 101b is removed from the patient’s body.
[100] The use of a compact generator assembly 102 in place of a traditional generator, enhances its portability and reduces the overall size of the tissue removal device 100. The incorporation of fixed, non-detachable blades in the tissue removal device 100 ensures durability and convenience, eliminating the need for blade adjustments. The switch assembly 103 serves dual functions for oscillation and forward control, simplifying the operation and providing users with efficient control. The controller 102b and the motor driver 102c maintain consistent speed for both functions, contributing to precision and ease of use. In terms of economic benefits, the invention is cost-effective, combining lightweight materials and a compact design. The tissue removal device's 100 overall weight is minimized, making it easily portable and convenient for transportation. Additionally, the disposable nature of the invention adds a layer of convenience, eliminating the need for extensive maintenance. The handheld design of the headpiece assembly 101 further enhances the device's practicality and ease of use, making it a versatile and user-friendly tool. The non-detachability of the blades from the housing makes the headpiece assembly suitable for a single-use, eliminating the risk of contamination and improving patient safety.
[101] The tissue removal device 100 finds diverse applications in various medical procedures, catering to specialized fields such as sinus surgery, trans nasal skull base surgery, otology, neurotology, and lateral skull base surgery. Specifically designed for intricate sinus procedures, the tissue removal device 100 effectively addresses conditions like nasal polyps, chronic sinusitis, and other sinus-related issues. In trans nasal skull base surgery, the tissue removal device 100 proves invaluable for delicate surgeries involving the skull base through the nasal passage, enabling precise and controlled tissue removal in this intricate anatomical region. In otology, the tissue removal device 100 can be applied to procedures related to the ear, offering solutions for conditions affecting the external, middle, and inner ear. This includes surgeries for hearing restoration, treatment of ear infections, and management of disorders impacting the auditory system. For neurotology, the tissue removal device 100 can be used in surgeries related to the nervous system of the ear, particularly focusing on treating neurological conditions affecting hearing and balance. Furthermore, the tissue removal device 100 is instrumental in lateral skull base surgery, targeting procedures involving the lateral skull base, which encompass surgeries related to tumors, acoustic neuromas, and other conditions affecting the lateral aspects of the skull. The tissue removal device 100 is intricately designed to meet the specific demands of these advanced surgical areas, providing surgeons with a precise and efficient tool for tissue removal and surgical interventions. The adaptability of the tissue removal device 100 in such specialized fields underscores its utility in addressing complex medical conditions, with a keen emphasis on precision and positive patient outcomes.
[102] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one ordinary skilled in the art to which this invention belongs. The system, methods, and examples provided herein are illustrative only and not intended to be limiting.
[103] While specific language has been used to describe the present subject matter, any limitations arising on account thereto, are not intended. As would be apparent to a person in the art, various working modifications may be made to the method to implement the inventive concept as taught herein. The drawings and the forgoing description give examples of embodiments. Those skilled in the art will appreciate that one or more of the described elements may well be combined into a single functional element. Alternatively, certain elements may be split into multiple functional elements. Elements from one embodiment may be added to another embodiment.
[104] 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 tissue removal device (100) comprising:
a. a first housing (1);
b. a motor (101a) disposed within the first housing (1) and configured to rotate and having a motor shaft (101c);
c. a motor gear (9) disposed within the first housing (1) and rotatably coupled to the motor shaft (101c);
d. a rotor gear (5) disposed within the first housing (1) and rotatably coupled to the motor gear (9); and
e. an inner tube assembly (4) comprising an inner shaft (4a) rotatably coupled to the rotor gear (5) and having a first blade (101b1) provided at a distal end of the inner shaft (4a);
f. wherein in response to the rotation of the motor (101a), the inner shaft (4a) and the first blade (101b1) are configured to rotate;
g. wherein the inner shaft (4a) is partially disposed outside the housing (1) and the inner shaft (4a) and the first blade (101b1) are non-detachable from the first housing (1).
2. The tissue removal device (100) as claimed in claim 1, wherein the tissue removal device (100) comprises an outer tube assembly (13) coupled to the inner tube assembly (4) and the first housing (1), the outer tube assembly (13) comprising an outer shaft (13e) configured to receive the inner shaft (4a) and having a second blade (101b2) provided at a distal end of the outer shaft (13e) and aligned with the first blade (101b1); the second blade (101b2) is configured to remain stationary; wherein the outer shaft (13e) is partially disposed outside the first housing (1) and the outer shaft (13e) and the second blade (101b2) are non-detachable from the first housing (1).
3. The tissue removal device (100) as claimed in claim 2, wherein the outer tube assembly (13) comprises a hub (13a) provided at a proximal end of the outer tube assembly (13) and coupled to the first housing (1), the hub (13a) having a passage (13a1) configured to receive a proximal portion of the outer shaft (13e) and a port (13b) configured to provide a passage for a saline solution.
4. The tissue removal device (100) as claimed in claim 3, wherein the outer tube assembly (13) comprises:
a. a sealing member (13d) coupled to the hub (13a) and having a proximal disc disposed outside the hub (13a), a distal disc disposed inside the passage (13a1) and a lumen providing a passage for the inner shaft (4a); and
b. a washer (13c) provided around the inner shaft (4a) and positioned distal to the sealing member (13d).
5. The tissue removal device (100) as claimed in claim 1, wherein:
a. the motor gear (9) comprises a first shaft (9b) rotatably coupled to the motor shaft (101c) and a first gearwheel (9a) coupled to the first shaft (9b) and having a plurality of teeth (9d), the first gearwheel (9a) configured to rotate in response to the rotation of the motor shaft (101c); and
b. the rotor gear (5) comprising a second gearwheel (5b) having a plurality of teeth (5d) configured to engage with the teeth (9d) of the motor gear (9), and a second shaft (5a) coaxially disposed within the second gearwheel (5b) and coupled to the inner shaft (4a);
c. wherein in response to the rotation of the motor (101a), the second shaft (5a) is configured to rotate the inner shaft (4a) and the first blade (101b1).
6. The tissue removal device (100) as claimed in claim 5, wherein a proximal end of the inner shaft (4a) is disposed within and coupled to a cavity (5e) of the second shaft (5a).
7. The tissue removal device (100) as claimed in claim 5, wherein the second shaft (5a) comprises a pair of wings (5c) provided at a distal end of the second shaft (5a), wherein the inner tube assembly (4) comprises an enclosure (4b) coupled to the housing (1) and enclosing a proximal portion of the inner shaft (4a), the enclosure (4b) comprising a pair of slots (4b1), each of the pair of slots (4b1) configured to receive a respective wing (5c) of the pair of wings (5c).
8. The tissue removal device (100) as claimed in claim 7, wherein the inner tube assembly (4) comprises a spring (4c) provided inside the enclosure (4b) and disposed over the inner shaft (4a) and a washer (4d) provided at a proximal end of the enclosure (4b).
9. The tissue removal device (100) as claimed in claim 5, wherein the tissue removal device (100) comprises a suction tube (2) configured to couple with a suction device capable of generating a suction force, the suction tube (2) comprising a passage (2d) extending for an entire length of the suction tube (2) and a coupling portion (2e) configured to receive a proximal portion of the second shaft (5a) of the rotor gear (5), wherein a lumen of the inner shaft (4a), a cavity (5e) of the second shaft (5a) and the passage (2d) of the suction tube (2) are aligned with each other.
10. The tissue removal device (100) as claimed in claim 1, wherein the tissue removal device (100) comprises:
a. a switch assembly (103) configured to:
i. send a first actuation signal indicative of a first mode; and
ii. send a second actuation signal indicative of a second mode; and
b. a generator assembly (102) coupled to the switch assembly (103) and the motor (101a), the generator assembly (102) configured to:
i. in response to receipt of the first actuation signal, send a first motor control signal to the motor (101a) to rotate the motor (101a) in the first mode; or
ii. in response to receipt of the second actuation signal, send a second motor control signal to the motor (101a) to rotate the motor (101a) in the second mode
c. wherein, in the first mode, the motor (101a) rotates in a pre-defined direction;
d. wherein, in the second mode, the motor (101a) rotates alternately in a first pre-defined direction from a first pre-defined angle to a second pre-defined angle and in a second direction from the second pre-defined angle to the first pre-defined angle.
11. The tissue removal device (100) as claimed in claim 10, wherein the generator assembly (102) comprises:
a. a controller (102b) coupled to the switch assembly (103) and configured to:
i. receive the first actuation signal;
ii. in response to receipt of the first actuation signal, send a first control signal indicative of the first mode;
iii. receive the second actuation signal; and
iv. in response to receipt of the second actuation signal, send a second control signal indicative of the second mode; and
b. a motor driver (102c) coupled to the controller (102b) and the motor (101a), the motor driver (102c) configured to:
i. receive the first control signal;
ii. in response to receipt of the first control signal, send the first motor control signal to the motor (101a);
iii. receive the second control signal; and
iv. in response to receipt of the second control signal, send the second motor control signal to the motor (101a).
12. The tissue removal device (100) as claimed in claim 11, wherein the switch assembly (103) comprises a first switch (103a) and a second switch (103b), wherein the switch assembly (103) is configured to:
a. send the first actuation signal in response to actuation of the first switch (103a); and
b. send the second actuation signal in response to actuation of the second switch (103b).
13. The tissue removal device (100) as claimed in claim 10, wherein the second motor control signal comprises a second pulse wave signal having a plurality of pulses, each of the pulses comprising:
a. a first phase comprising a positive signal of a pre-defined voltage for a first time period (T1);
b. a second phase following the first phase and comprising a first guard signal having zero voltage for a second time period (T2);
c. a third phase following the second phase and comprising a negative signal of the pre-defined voltage for a third time period (T3); and
d. a fourth phase following the third phase and comprising a second guard signal having zero voltage for a fourth time period (T4).
14. The tissue removal device (100) as claimed in claim 1, wherein the tissue removal device (100) comprises a motor cap (8) coupled to the motor (101a) at a distal end of the motor (101a) and comprising a slot (8a) configured to provide a passage to the motor shaft (101c).
15. The tissue removal device (100) as claimed in claim 1, wherein the tissue removal device (100) comprises a plurality of washers (7a, 7b, 7c) coupled to the motor (101a).