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:
ASPIRATION THROMBECTOMY DEVICE WITH INTEGRATED INFUSION SYSTEM
2. APPLICANT:
Meril Life Sciences Pvt Ltd., an Indian company of the Survey No. 135/139 Bilakhia House, Muktanand Marg, Chala, Vapi-Gujarat 396191, India.

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

FIELD OF DISCLOSURE
[1] The present disclosure relates to medical devices. More particularly, the present disclosure relates to an aspiration thrombectomy device with an integrated infusion system.
BACKGROUND OF INVENTION
[2] Human blood vessels often become occluded or blocked by plaque, clot or thrombi, other deposits, or emboli which reduce the blood carrying capacity of the vessel. Blockage of blood vessels is one of the common causes of deadly diseases affecting mankind such as myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis, atrial fibrillation, infective endocarditis etc. Blood vessel occlusions if not detected early or treated promptly can result in life-threatening conditions including death.
[3] Surgical interventions for blocked vasculature include thrombectomy, atherectomy, deployment of stents, infusion of medications that dissolve the blood clots such as thrombolytics or anti-coagulants, angioplasty etc. A thrombectomy is a surgical procedure employed to remove blood clots in an artery or vein to help restore blood flow in blood vessels. Aspiration thrombectomy, a type of mechanical thrombectomy procedure involving aspiration or evacuation of the blood clot or thrombus through vacuum assistance. Although, very effective, aspiration thrombectomy often needs to be terminated due to increased blood loss, undesirably aspirating healthy, clot-free blood etc. Further, in situations where infusion of blood clot dissolving medications is required along with thrombus aspiration, first the infusion system needs to be set up to complete the infusion procedure thereafter, the aspiration thrombectomy device to affect the thrombus removal is arranged. This leads to increase in overall procedure time. Additionally, conventional aspiration systems lead to increased blood loss due to manual control of aspiration rate and/or continued aspiration.
[4] Hence, there is a need of an aspiration thrombectomy device that overcomes the problems associated with the conventional devices.
SUMMARY OF 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 medical device. In an embodiment, the medical device includes a motor, an aspiration unit and an infusion unit. The aspiration unit includes an aspirator, a suction tube and a collector tank. The aspirator is coupled to the motor and is configured to generate a suction force, in response to the rotation of the motor, to aspirate thrombus located at a target site. The suction tube includes a lumen configured to provide a passage for an aspirated fluid to the collector tank, wherein the aspirated fluid comprises the thrombus. A distal end of the suction tube is detachably coupled to a first catheter having an aspiration lumen providing a passage for the aspirated fluid. The collector tank is coupled to the aspirator via an inlet duct and is coupled to the suction tube at a port of the collector tank. The collector tank is configured to collect the aspirated fluid. The infusion unit includes a reservoir, an outlet duct and an impeller. The reservoir holds an infusion fluid. The outlet duct is coupled to an outlet port of a casing and is configured to provide a passage for the infusion fluid. The impeller is enclosed within the casing and is coupled to the motor. The impeller is configured to generate a centrifugal suction force, in response to the rotation of the motor, driving the infusion fluid from the reservoir into the outlet duct. The outlet duct is detachably coupled to a second catheter having an infusion lumen providing passage to the infusion fluid to be delivered at the target site.
BRIEF DESCRIPTION OF ACCOMPANYING 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 depicts a schematic diagram of a device 100 according to an embodiment of the present disclosure.
[9] Fig. 2 depicts a schematic diagram of coupling of a first pressure sensor 40a and a second pressure sensor 40b with a suction tube 50, according to an embodiment of the present disclosure.
[10] Fig. 3 depicts a plurality of positions on a control element 12, according to an embodiment of the present disclosure.
[11] Fig. 4 depicts a flowchart of a method 300 of operating a thrombus aspiration unit 45 of the device 100, according to an embodiment of the present disclosure.
[12] Fig. 5 depicts the device 100 when the thrombus aspiration unit 45 is set-up according to an embodiment of the present disclosure.
[13] Fig. 6 depicts the device 100 when the thrombus is detected in the vascular system, according to an embodiment of the present disclosure.
[14] Fig. 7 depicts the device 100 after removing the thrombus from the vascular system, according to an embodiment of the present disclosure.
[15] Fig. 8 depicts a flowchart of a method 700 of operating the infusion unit 85 of the device 100, according to an embodiment of the present disclosure.
[16] Fig. 9 depicts the device 100 when the infusion unit 85 is switched ON, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE DRAWINGS
[17] 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.
[18] 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.
[19] 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.
[20] Furthermore, the described includes, 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 includes or advantages of a particular embodiment. In other instances, additional includes and advantages may be recognized in certain embodiments that may not be present in all embodiments. These includes 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.
[21] This current disclosure pertains to an aspiration thrombectomy device (or a device) with an integrated infusion system. In an exemplary embodiment, the device of the present disclosure includes a combination of an aspiration unit and an infusion unit, which is used as a component of catheter delivery system. For example, the device of the present disclosure is used as an integral part of a catheter delivery system utilized for aspiration procedures within blood vessels. Additionally, it is employed for promptly infusing the fluids or medications in a controlled manner.
[22] Although, the device of the present disclosure is described with example of thrombectomy and followed by immediate infusion of the fluid that were lost during the thrombectomy procedure, the teachings of the present disclosure are equally applicable to other aspiration procedures (for example embolectomy, atherectomy etc.) and infusion procedures (for example, intravenous fluid, medications, nutrients, chemotherapy infusions etc.) whether performed dependently or independently. The same is within the scope of the teachings of the present disclosure.
[23] The combination of the aspiration unit and the infusion unit functions into the device allows for more accurate and coordinated control over fluid dynamics within the catheter. This is particularly important in procedures where the balance between aspiration (removing fluids or materials) and infusion (delivering fluids or medications) is crucial. In an exemplary embodiment, the combined aspiration unit and infusion unit are driven by a single motor. The motor can be operated by both AC power supply and battery power supply. The motor system regulates the function of both the units simultaneously or independently, as per requirement. This reduces complexity of the device.
[24] In an exemplary embodiment, the device includes a thrombus aspiration unit, as an integral part of the catheter system. The thrombus aspiration unit uses a detection system for automatic identification of the clot or thrombus in the vascular systems and uses a vacuum or suction mechanism that allows it to gently remove the blood clot or thrombus causing the blockage in the vascular systems. The thrombus aspiration unit is coupled to the catheter, and which is introduced into the vascular system. The thrombus aspiration unit is designed to activate automatically upon detecting the thrombus and/or clot within the vascular system. The suction force is applied by the thrombus aspiration unit to extract the clot from the vascular system. After thrombus and/or clot removal, the thrombus aspiration unit is designed to deactivate the suction force automatically.
[25] Thrombus aspiration units, for example, may be used in the field of interventional cardiology to remove blood clots or thrombi from blood vessels, like in cases of acute myocardial infarction (heart attack) or other instances where a blood clot is causing a blockage. These are designed to help restore blood flow and prevent further damage to the heart muscle or other vital organs. Additionally, the aspiration unit can be used for extracting phlegm in a setting outside of an operation theater (e.g., hospital bed, outside patient department, home, etc.). The manual regulating controls allows the device to be used in babies, children, adults and old age people.
[26] In an exemplary embodiment, the device further includes an infusion unit, a component of the catheter system. The infusion unit is used to deliver fluids, such as medications, nutrients, or other therapeutic substances, into a patient's body in a controlled and accurate manner. These infusion units provide a continuous and consistent flow of fluids or medications, ensuring a steady supply to the catheter and, subsequently, to the target area within the patient's body.
[27] The device can improve procedure efficiency by streamlining the process. Healthcare providers can switch between aspiration and infusion modes seamlessly, reducing the need for multiple devices or manual adjustments. Minimizing the number of connections and components in a catheterization setup can reduce the risk of contamination and infection. The device may help maintain a closed and sterile circuit, promoting patient safety.
[28] Coordination between aspiration and infusion functions can enhance safety during procedures. For example, in angiographic procedures, the ability to infuse the contrast media accurately, aspirating the clot(s) in a blood vessel and then immediately following with an infusion of therapeutic agents or saline can minimize the risk of complications. The device helps in reducing the time required to perform procedures, as healthcare providers can efficiently manage fluid dynamics without having to switch between separate devices or manually adjust settings. The device is more compact and portable than separate devices, making them suitable for various clinical settings, including operating rooms, catheterization labs, and mobile units.
[29] Now referring to the figures, Fig. 1 illustrates an exemplary embodiment of a medical device 100 (or device 100). The device 100 may include a plurality of components operationally coupled to each other. In an exemplary embodiment, as shown in Fig. 1, the device 100 includes a thrombus aspiration unit 45 (interchangeably referred to as an aspiration unit 45), an infusion unit 85 and a motor 75.
[30] A first catheter 20 is coupled to the aspiration unit 45 and thrombus is removed from the vasculature system of an individual by applying a suction force, which has been explained later. The first catheter 20 has a tubular structure. The length of the first catheter 20 may be between 300 mm to 2000 mm. In an embodiment, the length of the first catheter 20 is 1300 mm. The first catheter 20 is made of a material such as, without limitation, silicone, polyether block amide (PEBAX), nylon, Teflon, etc. The first catheter 20 includes one or more lumens. In an embodiment, the first catheter 20 includes an aspiration lumen through which the thrombus is aspirated. The first catheter 20 may also include an infusion lumen to infuse an infusion fluid at a target site during a medical procedure. The first catheter 20 includes a proximal end 20b and a distal end 20a. The proximal end 20b of the first catheter 20 is coupled to the thrombus aspiration unit 45 and the distal end 20a is introduced into the vasculature system. In an exemplary embodiment, the thrombus aspiration unit 45 may include an aspirator 56, a suction tube 50, a collector tank 52, an inlet duct 54, an outlet duct 58 and an air purifier 54’.
[31] In an exemplary embodiment, the aspirator 56 may include a body 56a and a piston 56b. The body 56a of the aspirator 56 is hollow from inside and has a suitable shape, such as, cylindrical, cuboidal, etc., according to an embodiment. When the suction force is applied during the operation of the thrombus aspiration unit 45, air would be sucked into the body 56a of the aspirator 56. A distal end of the body 56a is close ended and a proximal end of the body 56a includes an opening for the piston 56b to couple with and move within the body 56a.
[32] In an embodiment, the piston 56b is ‘T’ shaped having a piston head 56b1 at a distal end of the piston 56b and a piston rod 56b2 extending therefrom. The piston head 56b1 of the piston 56b is inserted into the body 56a and is configured to move back and forth within the body 56a during the operation of the aspiration unit 45. Cross-sectional shape and dimension of the piston head 56b1 corresponds to the cross-sectional shape and dimensions of the body 56a. In an embodiment, the piston head 56b1 is cylindrical in shape. In an example implementation, the piston 56b is a reciprocating piston. The piston head 56b1 is provided with a rubber seal (not shown) to prevent any leakage of the aspirated fluid from the body 56a of the aspirator 56 during the operation of the device 100.
[33] In an embodiment, the body 56a may include two ports, namely, 56a1 and 56a2 provided at the distal end of the body 56a. The ports 56a1 and 56a2 may be placed perpendicular to the central axis of the piston head 56b1. In an embodiment, the outlet duct 58 is coupled to the port 56a1 which transports the entrapped air out of the aspirator 56. The outlet duct 58 acts like a muffler helping in dampening the noise produced when the entrapped air moves out of the aspirator 56. In an embodiment, one end of the inlet duct 54 is coupled to the port 56a2. The other end of the inlet duct 54 is coupled to a floating chamber 54’’. In another embodiment, the other end of the inlet duct 54 may be directly inserted into the collector tank 52 through a port 52b provided at a ceiling of the collector tank 52 without the floating chamber 54’’.
[34] The collector tank 52 collects the thrombus aspirated from a target site. In an embodiment, the collector tank 52 may have a capacity ranging between 200 ml to 1500 ml. In an exemplary embodiment, the collector tank 52 has a capacity of 1000 ml. The collector tank 52 is cylindrical, in an embodiment, though it may be of any other suitable shape. In an embodiment, the collector tank 52 is provided with a removable ceiling that could be removed while transferring or emptying the captured thrombus and blood from the collector tank 52. The collector tank 52 receives the floating chamber 54’’ through the port 52b provided at the ceiling.
[35] The floating chamber 54’’ is provided with a float (not shown). The float is concentrically disposed at a mouth of the floating chamber 54’’ inside a frame (not shown) of the floating chamber 54’’. The float may be made of rubber, or any other suitable material.
[36] When the piston head 56b1 moves backward in the body 56a, a vacuum is created, which in turn creates a suction force. The suction force causes the air from the collector tank 52 sucked into the inlet duct 54 through the opening of the floating chamber 54’’. The air is purified by the air purifier 54’. Thereafter, the air enters the aspirator 56 via the port 56a2. When the piston head 56b1 moves forward in the body 56a, this air is pushed out of the aspirator 56 via the outlet duct 58 through the port 56a1. The air purifier 54’ may be placed at a suitable location along the length of the inlet duct 54 for purifying the aspired air from the collector tank 52.
[37] When the aspired fluid collected in the collector tank 52 reaches the mouth of the floating chamber 54’’, the float comes in contact with the aspired fluid. The float moves upwards as more aspired fluid is collected in the collector tank 52. When the aspired fluid reaches a pre-defined height, the float touches and blocks the mouth of the inlet duct 54. As a result, the float prevents the flow of the aspired fluid into the inlet duct 54. When the collector tank 52 is emptied, the float returns to the mouth of the floating chamber 54’’.
[38] The collection tank 52 includes another port 52a at the ceiling that receives the suction tube 50. A proximal end of the suction tube 50 is coupled to the port 52a. A distal end of the suction tube 50 is removably coupled to the first catheter 20. The suction tube 50 includes a lumen (not shown) that receives the aspired fluid from the first catheter 20 and provides a passage for the aspired fluid to pass through it and reach the collector tank 52.
[39] In an embodiment, the first catheter 20 may include a hub 30. A distal end of the hub 30 is coupled to the proximal end 20b of a shaft of the first catheter 20. A proximal end of the hub 30 is coupled to the distal end of the suction tube 50. The hub 30 facilitates a controlled flow of the fluid and reduces the chances of blood loss of the patient during medical procedure. In another embodiment, the first catheter 20 may be coupled to the distal end of the suction tube 50 without the hub 30.
[40] In an embodiment, the aspiration unit 45 may include an On-Off valve 32. One port of the On-Off valve 32 is coupled to the proximal end 20b of the first catheter 20. The other port of the On-Off valve 32 is coupled to the suction tube 50. The On-Off valve 32 is configured to open or close the lumen of the suction tube 50 as needed. The On-Off valve 32 is operated manually to open and close the lumen of the suction tube 50 as per requirement. For example, healthcare practitioners open the On-Off valve 32 while setting up the aspiration unit 45 for allowing the passage of the aspired fluid from the first catheter 20 into the lumen of the suction tube 50.
[41] In an embodiment, the aspiration unit 45 includes a thrombus detection system configured to detect a clot or thrombus in the vasculature system. The thrombus detection system is further configured to automatically activate the aspirator 56 (and hence, the thrombus aspiration unit 45) when the clot or the thrombus is detected (i.e., presence of thrombus) and automatically deactivate the aspirator 56 (and hence, the aspiration unit 45) when the clot or the thrombus is removed or the clot or the thrombus is not detected (i.e., absence of thrombus), which has been explained later. In an embodiment, the thrombus detection system includes a pressure sensing unit 40, a first pressure sensor 40a, and a second pressure sensor 40b.
[42] The first pressure sensor 40a and the second pressure sensor 40b are coupled to the suction tube 50. In an exemplary embodiment, the second pressure sensor 40b is provided towards the proximal end of the suction tube 50. The first pressure sensor 40a is provided towards the distal end of the suction tube 50, positioned proximally to the On-Off valve 32. The first pressure sensor 40a and the second pressure sensor 40b are configured to sense a pressure within the suction tube 50 at a respective location where they are provided. One embodiment of the first pressure sensor 40a and the second pressure sensor 40b being coupled to the suction tube 50 is illustrated in Fig. 2. In an embodiment, the first pressure sensor 40a includes a T-shaped coupling A coupled perpendicular to the suction tube 50. Similarly, the second pressure sensor 40b includes a T-shaped coupling B coupled perpendicular to the suction tube 50 The first pressure sensor 40a and the second pressure sensor 40b include a suitable pressure transducer converting the sensed pressure values into corresponding electrical signals.
[43] The aspiration unit 45 includes a mechanical valve 40c coupled with the suction tube 50 and disposed between the first pressure sensor 40a and the second pressure sensor 40b as shown in Fig. 1. The mechanical valve 40c is configurable to be in at least a partially closed position and an open position, automatically regulated by the pressure sensing unit 40 as explained later.
[44] The pressure sensing unit 40 is coupled to the first pressure sensor 40a and the second pressure sensor 40b. The pressure sensing unit 40 is configured to detect the presence of the thrombus and/or the removal of the thrombus based upon the pressure values sensed by at least one of the first pressure sensor 40a and the second pressure sensor 40b. In an embodiment, the pressure sensing unit 40 detects the presence of the thrombus and/or the removal of the thrombus based a differential pressure value, i.e., based upon a difference of the pressure values sensed by the first pressure sensor 40a and the second pressure sensor 40b.
[45] In an embodiment, when the distal end 20a of the first catheter 20 comes in contact with thrombus, the first pressure sensor 40a is activated and sends values of the pressure sensed to the pressure sensing unit 40. In an embodiment, the pressure detected by the first pressure sensor 40a increases in such a situation whereas the pressure detected by the second pressure sensor 40b remains constant. According to an embodiment, the pressure sensing unit 40 calculates a difference between the pressure sensed by the second pressure sensor 40b and the pressure sensed by the first pressure sensor 40a. When the pressure sensing unit 40 detects a negative pressure difference (i.e., the pressure detected by the first pressure sensor 40a is more than that sensed by the second pressure sensor 40b), the pressure sensing unit 40 determines that the thrombus is present. The pressure sensing unit 40 then activates the aspiration unit 45 (explained in detailed later). Once the aspiration unit 45 is activated, the suction force is created and the thrombus is aspirated via the suction tube 50.
[46] In an embodiment, as the thrombus drops in the collector tank 52, there is an increase in the pressure sensed by the second pressure sensor 40b. This is due to the release in the pressure from the suction tube 50. The pressure sensing unit 40 detects a positive pressure difference (i.e., the pressure sensed by the second pressure sensor 40b is more than that sensed by the first pressure sensor 40a). In response to the detection of the positive pressure difference, the pressure sensing unit 40 determines that the thrombus is removed. Consequently, the pressure sensing unit 40 deactivates the aspiration unit 45. The pressure sensing unit 40 continues to keep the aspiration unit 45 deactivated until the distal end 20a of the first catheter 20 contacts the thrombus again. Thus, even during the aspiration procedure, the pressure sensing unit 40 activates the aspiration unit 45 intermittently, ensuring that the aspiration unit 45 is activated only for the duration from when the thrombus is detected and the detected thrombus is aspirated. This minimizes the overall blood loss for the patient during the aspiration procedure, thereby improving the patient outcome.
[47] In an embodiment, the pressure sensing unit 40 includes a control unit (not shown) that is configured to receive signals from the first pressure sensor 40a and the second pressure sensor 40b, detect the presence of the thrombus and/or the removal of the thrombus based upon the pressure values sensed by at least one of the first pressure sensor 40a and the second pressure sensor 40b, and send at least one control signal to activate/deactivate the aspiration unit 45 accordingly. The control unit may be a programmable logic controller (PLC), a microcontroller, or any other suitable circuit or computing device. In an exemplary embodiment, the control unit is a PLC.
[48] The motor 75 converts the electrical energy into mechanical rotational energy to drive the piston 56b (as explained later). In an embodiment, the motor 75 is a brushless DC (BLDC) motor. The motor 75 is operatively coupled to the aspirator 56. A shaft 75a1 is provided at one end of the motor 75. An eccentric sheave 75a2 is coupled to the shaft 75a1. The eccentric sheave 75a2 is further coupled with the end of piston rod 56b2 of the piston 56b. In an embodiment, the end of the piston rod 56b2 has a circular hole, which is coupled to the eccentric sheave 75a2. As the shaft 75a1 rotates, the eccentric sheave 75a2 moves back-and-forth, thereby, driving the piston 56b back-and-forth to create the suction force for aspirating the thrombus.
[49] On activation of the motor 75, the piston 56b moves based on eccentric mechanics. In other words, the eccentric mechanism (e.g., the eccentric sheave 75a2) of the motor 75 converts a rotational motion of the shaft 75a1 into a linear motion, which is then translated into the reciprocating movement of the piston 56b of the aspirator 56. This action of the piston 56b, in turn, generates the necessary suction force to draw air out of the collector tank 52, creating a vacuum inside the suction tube 50. The thrombus is aspirated from the vascular system due to this vacuum. The amount of suction force depends upon the rotational speed of the motor 75. Hence, activation/deactivation of the aspiration unit 45 and the aspiration rate of the aspiration unit 45 can be controlled by changing the rotational speed of the motor 75.
[50] In an embodiment, the rotational speed of the motor 75 is controlled with the help of a control element 12 and a rectifier 14. The control element 12 is electrically coupled to the motor 75, e.g., the power terminals of the motor 75 are coupled to the control element 12 using the connecting wires 6, as shown in Fig. 1. In an embodiment, the control element 12 is a knob with an ON/OFF switch. The control element 12 is manipulable (e.g., may be rotated to) to be in a plurality of positions including an ON position 12a1, an OFF position 12a2, an AUTO position 12a3 and one or more MANUAL positions 12a4, as shown in Fig. 3. The operation of the device 100 is controlled by the control element 12, according to an embodiment, which has been explained later.
[51] The device 100 includes a plug 10 that can be coupled to a corresponding socket for AC power supply, as shown in Fig. 1. The rectifier 14 is electrically coupled to the control element 12. The rectifier 14 receives AC power from the power supply and converts the AC power to a DC power. The rectifier 14 includes a step-up converter, a step-down converter and a controller. The controller may be a programmable logic controller (PLC), a microcontroller, or any other suitable circuit or computing device. In an example implementation, the controller is a PLC. The controller is electrically coupled to the pressure sensing unit 40. The controller is configured to receive the at least one control signal from the control unit of the pressure sensing unit 40 to activate/deactivate aspiration unit 45 and is configured to provide a third control signal or a fourth control signal to the pressure sensing unit 40 to control the mechanical valve 40c.
[52] The activation and deactivation of the aspiration unit 45 is now explained. The user plugs the plug 10 to the AC power supply and switches the aspiration unit 45 ON by rotating the control element 12 to the ON position 12a1. The rectifier 14 is activated. The controller controls the step-down converter to provide a first pre-defined voltage to the motor 75. The motor 75 is switched ON and the shaft 75a1 starts rotating at a first pre-defined rotational speed. The first pre-defined voltage and the first pre-defined rotational speed are designed such that the first pre-defined rotational speed is low enough so that the piston 56b moves minimally. Consequently, negligible suction force is generated and no aspiration takes place. Further, the mechanical valve 40c is partially closed (for example, closed by 90% or more) at this stage. The mechanical valve 40c may be partially closed before or after moving the control element 12 to the ON position 12a1. Thus, the aspiration unit 45 is in a deactivated state.
[53] Further, the user may then move the control element 12 to the AUTO position 12a3. In an embodiment, when the pressure sensing unit 40 determines the presence of thrombus, the control unit of the pressure sensing unit 40 sends a first control signal to the controller of the rectifier 14. The first control signal indicates that the thrombus is detected. Upon receiving the first control signal, the controller of the rectifier 14 controls the step-up converter to increase the voltage provided to the motor 75 from the first pre-defined voltage to a second pre-defined voltage. Consequently, the rotational speed of the motor 75 increases from the first pre-defined rotational speed to a second pre-defined rotation speed. The second pre-defined voltage and the second pre-defined rotation speed are designed such that the motor 75 rotates with enough high speed to move the piston 56b. As a result, the shaft 75a1 starts rotating at the second pre-defined rotation speed and the eccentric sheave 75a2 coupled to the shaft 75a1 moves linearly. This causes the piston 56b to move back-and-forth, which creates the vacuum in the suction tube 50, thereby activating the aspirator 56. The vacuum created in the suction tube 50 causes a drop in the pressure as compared to the pressure at the distal end 20a of the first catheter 20 and generates the suction force. Further, the controller of the rectifier 14 sends the third control signal to the control unit of the pressure sensing unit 40. Upon receiving the third control signal, the control unit of the pressure sensing unit 40 sends an electrical control signal to the mechanical valve 40c to set the mechanical valve 40c to the open position, thereby allowing the passage through the suction tube 50. The suction force causes the thrombus to move from the distal end 20a of the first catheter 20 via the suction tube 50 and drop into the collector tank 52. Thus, the aspiration unit 45 is activated automatically upon detecting the thrombus.
[54] According to an embodiment, the user can manually control the rotational speed of the motor 75 as required, for example, when the user observes that the suction force generated by the motor 75 is not sufficient to aspirate the thrombus or the aspirate rate is slow. The user can adjust the rotational speed of the motor 75 by rotating and setting the control element 12 to one of the MANUAL positions 12a4. According to an embodiment, the rotational speed of the motor 75 corresponding to each of the MANUAL positions 12a4 is greater than the second pre-defined rotational speed, wherein successive MANUAL positions 12a4 in the clockwise direction result in higher rotational speeds of the motor 75. Therefore, the motor 75 rotates at increasing higher speed, which increases the suction force. This results in aspirating more difficult thrombus and/or increasing the aspiration rate.
[55] In an embodiment, when the pressure sensing unit 40 detects that the thrombus is removed, the control unit of the pressure sensing unit 40 sends a second control signal to the controller of the rectifier 14. The second control signal indicates that the thrombus is removed. Upon receiving the second control signal, the controller of the rectifier 14 controls the step-down converter to decrease the voltage provided to the motor 75 from the second pre-defined voltage to the first pre-defined voltage. Consequently, the rotational speed of the motor 75 decreases from the second pre-defined rotational speed to first pre-defined rotation speed. As a result, the shaft 75a1 rotates at such low rotational speed that the eccentric sheave 75a2 moves negligibly, thereby substantially stopping the back-and-forth movement of the piston 56b. Consequently, no or negligible suction force is generated in the suction tube 50. Further, the controller of the rectifier 14 sends the fourth control signal to the control unit of the pressure sensing unit 40. Upon receiving the fourth control signal, the control unit of the pressure sensing unit 40 sends another electrical control signal to the mechanical valve 40c to set the mechanical valve 40c to the partially closed position, thereby preventing the passage through the suction tube 50. Therefore, no fluid is aspirated from the vascular system. Thus, the aspiration unit 45 is deactivated during the aspiration procedure once the detected thrombus is aspirated and the aspiration unit 45 remains deactivated until another thrombus is detected by the pressure sensing unit 40.
[56] The control element 12 is further coupled with a pressure gauge 16. The pressure gauge 16 is in connection with the inlet duct 54 in order to measure pressure in the aspiration unit 45. In an exemplary embodiment, a four-way connector 8 may help in achieving the connection. In an embodiment, the pressure gauge 16 includes a pointer and a dial having a plurality of indicators corresponding to negative gauge pressure values to show the pressure in the aspiration unit 45 during the aspiration procedure. The dial of the pressure gauge 16 also includes a plurality of indicators corresponding to positive gauge pressure values during the infusion procedure (as explained later).
[57] In an embodiment, the motor 75 also drives the infusion unit 85. In an embodiment, the infusion unit 85 includes an impeller 66, a hose 68, a stopcock 68a, a reservoir 80 and an outlet duct 74.
[58] In an embodiment, a shaft 62 extends from the motor 75 and couples with the impeller 66. The shaft 62 rotates when the motor 75 is powered by the rectifier 14 (e.g., when the control element 12 is at the ON position 12a1). A fan 64 is mounted over the shaft 62 and positioned between the motor 75 and the impeller 66. The fan 64 is used for cooling the motor 75 and prevents the motor 75 from overheating during the operation of the infusion unit 85 (and during the operation of the aspiration unit 45).
[59] The reservoir 80 is a container to hold an infusion fluid. It has a suitable shape such as cuboidal, cylindrical etc. and may have a capacity ranging between 100 ml to 2000 ml, according to an embodiment. In the depicted embodiment, the reservoir 80 has a cuboidal shape and a capacity of 1500 ml. In an embodiment, the impeller 66 and the hose 68 are encased within a casing 70 (as shown in Fig. 1). The hose 68 couples the reservoir 80 and the casing 70. The hose 68 has a hollow, tubular structure and provides a passage for the flow of the infusion fluid from the reservoir 80 into the casing 70. The hose 68 is coupled to the stopcock 68a which controls the movement of infusion fluid from the reservoir 80 into the casing 70. The casing 70 includes an outlet port which is coupled to the outlet duct 74. The outlet duct 74 has a hollow, tubular structure and provides a passage for the infusion fluid from the casing 70 into the vasculature system.
[60] The impeller 66, encased in the casing 70, includes a plurality of blades coupled to a central hub. The plurality of blades rotates when the shaft 62 rotates. The rotation of the impeller 66 coverts the rotation energy generated by the motor 75 into a mechanical suction force. This suction force drives the flow of the infusion fluid from the reservoir 80 through the hose 68 into the casing 70 and then to the outlet duct 74.
[61] The other end of the outlet duct 74 is coupled to a proximal end of a hemostasis Yvalve 74a, as shown in Fig. 1. A second catheter 76 is detachably coupled to a distal end of the hemostasis Y-hub 74a (as shown in Fig. 9) during the operation of the infusion unit 85. The second catheter 76 includes an infusion lumen, which allows a passage for the infusion fluid to be delivered to the target site, e.g., to dissolve a hard thrombus or clot. In an embodiment, separate catheters (e.g., the first catheter 20 and the second catheter 76) may be used during the medical procedure. In another embodiment, a single multi-lumen catheter having an aspiration lumen and an infusion lumen may be used. In this case, it will be understood that the first catheter 20 and the second catheter 76 refer to the same multi-lumen catheter.
[62] In an embodiment, a unidirectional duck valve 74b and an On-Off valve 74c are coupled to the outlet duct 74, as shown in Fig. 1. The unidirectional duck valve 74b guards the flow of infusion fluid from the outlet port into the outlet duct 74, preventing any backward flow of the infusion fluid. The flow of infusion fluid is further controlled by the On-Off valve 74c that may be positioned either proximal or distal to the unidirectional duck valve 74b. In an embodiment, the On-Off valve 74c is positioned distal to the unidirectional duck valve 74b. A filter element is coupled to the outlet duct 74, according to an embodiment. The filter element is placed inside the unidirectional duck valve 74b towards its proximal end. The filter element axially grips the outlet port using a coupling. The filter element is responsible for converting a turbulent flow of the infusion fluid into a laminar flow. This is done so as to prevent fluctuations in pressure within the infusion unit 85 from getting transferred to surrounding tissues, thereby preventing any shear stress within the vascular system during the infusion procedure. Further, it ensures the consistent and accurate delivery of the infusion fluid at a uniform rate.
[63] The pressure gauge 16 is coupled to the outlet duct 74, for example, via a T-connection 9 disposed between the On-Off valve 74c and the hemostasis Y-valve 74a, as shown in Fig. 1. In an embodiment, the pressure gauge 16 includes a pointer, a dial having a plurality of indicators corresponding to positive gauge pressure values to show the pressure generated in the infusion unit 85 during the infusion procedure.
[64] When the infusion unit 85 is activated (explained later) and the motor 75 and the shaft 62 rotate at the second pre-defined rotational speed. As a result, the impeller 66 and the fan 64 of the infusion unit 85 rotate. The rotational motion of the impeller 66 generates a positive centrifugal suction force that drives the infusion fluid from the reservoir 80 into the casing 70 via the hose 68. The infusion fluid leaves the casing 70 from the outlet duct 74 and is delivered at the target site via the second catheter 76 (shown in Fig. 9). The pressure gauge 16 is in connection with the outlet duct 74 and gauges the pressure generated by the infusion unit 85. The pressure gauge 16 helps in effective regulation of the infusion fluid flow.
[65] Fig. 4 depicts a flowchart of a method 300 of operating the thrombus activation unit 45 of the device 100, according to an embodiment of the present disclosure.
[66] At step 302, the aspiration unit 45 is set-up. To set-up the aspiration unit 45 for its operation, the mechanical valve 40c is partially closed. The plug 10 is plugged in into the main supply line. The stopcock 68a is closed and the On-Off valve 74c is opened. The control element 12 is turned to the ON position 12a1. The motor 75 starts running at the first pre-defined rotational speed. The first catheter 20 is coupled to the suction tube 50. The On-Off valve 32, coupled to the suction tube 50 is kept closed during coupling the first catheter 20 with the suction tube 50.
[67] At step 304, the first catheter 20 is inserted into the vasculature system. The On-Off valve 32, coupled to the suction tube 50 is opened before inserting the first catheter 20 into the vasculature system. Fig. 5 illustrates the device 100 at the time of insertion of the first catheter 20 into the vasculature system. Once the first catheter 20 is inserted into the vasculature system, the control element 12 is turned to AUTO position 12a3. This activates the thrombus detection mechanism of the aspiration unit 45.
[68] At step 306, the first catheter 20 is advanced into the vasculature system to a target site.
[69] At step 308, the pressure sensing unit 40 detects the presence of thrombus as the distal end 20a of the first catheter 20 comes in contact with the thrombus (as shown in Fig. 6). As explained earlier, when the distal end 20a of the first catheter 20 comes in contact with the thrombus, the pressure detected by the first pressure sensor 40a increases and is more than the pressure sensed by the second pressure sensor 40b. This pressure difference causes the pressure sensing unit 40 to detect the presence of the thrombus.
[70] At step 310, the pressure sensing unit 40 automatically activates the aspiration unit 45 as explained earlier. In an embodiment, the pressure sensing unit 40 sends the first control signal to the rectifier 14. The first control signal indicates that the thrombus is detected. In response to the first control signal, the rectifier 14 provides power to the motor 75. This causes the shaft 75a1 to increase its rotational speed (from the first pre-defined rotational speed to the second pre-defined rotational speed) and the eccentric sheave 75a2 to move back-and-forth. The piston 56b increases its speed to move back-and-forth in the body 56a of the aspirator 56 as a result. The pressure sensing unit 40, in response to the third control signal from the rectifier 14 completely opens the mechanical valve 40c. Thus, the vacuum force in the aspiration unit 45 is activated. Fig. 6 illustrates the device 100 when the aspiration unit 45 is activated.
[71] At step 312, the aspiration unit 45 aspirates the thrombus from the target site. The back-and-forth movement of the piston 56b creates a vacuum inside the suction tube 50. The vacuum in the suction tube 50 results in a suction force and causes the movement of the thrombus from the distal end 20a of the first catheter 20 into the collector tank 52 via the suction tube 50. Further, this causes the deflection of the needle of the pressure gauge 16 to indicate a negative pressure in the suction tube 50. In an embodiment, the user may manually regulate the pressure in the suction tube 50 by rotating the control element 12 to any of the MANUAL positions 12a4. In this case, the user may view the pressure value from the pressure gauge 16 and adjust the control element 12 to control the pressure as desired.
[72] At step 314, the pressure sensing unit 40 detects complete removal of the thrombus. As the thrombus is dropped into the collector tank 52 (and providing that the distal end 20a of the first catheter 20 is not contacting the thrombus), the pressure within the suction tube 50 is released. The pressure detected by the second pressure sensor 40b is more than the pressure detected by the first pressure sensor 40a. Based upon this pressure differential, the pressure sensing unit 40 determines that the thrombus has been removed completely. Fig. 7 illustrates the device 100 in this condition, according to an embodiment.
[73] At step 316, the pressure sensing unit 40 automatically deactivates the aspiration unit 45 as described earlier. In an embodiment, the pressure sensing unit 40 sends the second control signal to the rectifier 14. The second control signal indicates that the thrombus has been removed completely. Upon receiving the second control signal, the rectifier 14 decreases the power supply to the motor 75 from the second pre-defined voltage to the first pre-defined voltage. This results in decreasing the rotational speed of the shaft 75a1 to the first pre-defined rotational speed and the movement of the eccentric sheave 75a2, which causes to decrease the back-and-forth movement of the piston 56b to slow down. As a result, negligible or no suction force is created. Further, the pressure sensing unit 40, in response to the fourth control signal from the rectifier 14, partially closes the mechanical valve 40c. The aspiration unit 45 is, thus, deactivated.
[74] Fig. 8 depicts a flowchart of a method 700 of operating the infusion unit 85 of the device 100, according to an embodiment of the present disclosure.
[75] At step 702, the infusion unit 85 is set-up for an infusion procedure. In an embodiment, the infusion unit 85 is set-up as below. The suction tube 50 is disconnected from the collector tank 52. Alternatively, or in addition, the inlet duct 54 is disconnected from the port 56a2. Further, the pressure sensing unit 40 is disconnected from the rectifier 14. This opens a closed loop connection between the thrombus aspiration unit 45 and the motor 75. Further, the plug 10 is plugged in into the main supply line. The infusion fluid is filled into the reservoir 80.
[76] At step 704, the second catheter 76 is coupled to the hemostasis Y-hub 74a. In an embodiment, the proximal end of the second catheter 76 is coupled to the distal end of the hemostasis Y-hub 74a. In an embodiment, when the same catheter (e.g., the first catheter 20) is used for both aspiration and infusion procedures, the proximal end 20b of the first catheter 20 is coupled to the distal end of the hemostasis Y-hub 74a.
[77] At step 706, the second catheter 76 is advanced into the vasculature system to a target site for the infusion procedure.
[78] At step 708, the infusion unit 85 is switched ON when the second catheter 76 reaches the target site for the infusion procedure. In an embodiment, the control element 12 is rotated to the ON position 12a1 to switch the infusion unit 85 ON. Further, the On-Off valve 74c is opened and the stopcock 68a is opened. Once the control element 12 is rotated to the ON position 12a1, the motor 75 is switched ON, the shaft 62 rotates as the first pre-defined rotational speed. The control element 12 is rotated to the AUTO position 12a3. Consequently, the shaft 62, and hence, the impeller 66, increases the respective rotational speed, thereby activating the infusion unit 85. Fig. 9 illustrates the device 100 when the infusion unit 85 is switched ON, according to an embodiment.
[79] At step 710, the infusion unit 85 infuses the target site with the infusion fluid. As explained earlier, once the motor 75 rotates at the second pre-defined rotational speed, the impeller 66 rotates creating a centrifugal suction force. The infusion fluid flows from the reservoir 80 into the casing 70 and then to the outlet duct 74 due to the centrifugal suction force. The infusion fluid is then delivered to the target site via the second catheter 76. The pressure gauge 16 detects the pressure in the outlet duct 74 and deflects the needle of the pressure gauge 16 to an appropriate indicator showing the pressure value of the outlet duct 74. The user may control the rate of flow of the infusion fluid by moving the control element 12 to any of the MANUAL positions 12a4. The pressure gauge 16 shows the positive pressure during the infusion procedure and the user can rotate the control element 12 until a desired pressure is reached as shown by the pressure gauge 16.
[80] At step 712, the infusion unit 85 is switched OFF once the infusion procedure is complete. In an embodiment, the infusion unit 85 is switched OFF by moving the control element 12 to the OFF position 12a2. Further, the On-Off valve 74c and the stopcock 68a may be closed. The second catheter 76 is then removed from the vasculature system.
[81] In an embodiment, the infusion procedure may be performed during the aspiration procedure to treat hard thrombus or blood clot or after the aspiration procedure to deliver infusion fluids (e.g., medication) to the target site. Thus, the infusion unit 85 and the aspiration unit 45 may be used one after the other. The device 100 having both the aspiration unit 45 and the infusion unit 85 in a single device 100 and driven by the same motor 75 enables the user to perform these procedures without having to change devices during the medical procedure. This reduces the overall procedure time and reduces the cost. In another embodiment, the device 100 enables the user to employ the aspiration unit 45 and the infusion unit 85 separately for perform respective procedures independently without requiring two separate devices. Further, a single motor (the motor 75) drives both the aspiration unit 45 and the infusion unit 85. This reduces the user’s overall cost.
[82] Further, device 100 may include a battery pack (not shown) to drive the motor 75 or a DC power may be provided on a casing of the device 100 to couple the battery pack externally. This allows the device 100 to function even in situation when AC power supply is not available, for example, during emergency situations at a remote location or extracting phlegm outside of an operation theater. This improves the overall usability of the device 100.
[83] 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 medical device (100) comprising:
a. a motor (75);
b. an aspiration unit (45) comprising:
i. an aspirator (56) coupled to the motor (75) and configured to generate a suction force, in response to the rotation of the motor (75), to aspirate thrombus located at a target site;
ii. a suction tube (50) comprising a lumen configured to provide a passage for an aspirated fluid; a distal end of the suction tube (50) is detachably coupled to a first catheter (20) having an aspiration lumen providing a passage for the aspirated fluid, wherein the aspirated fluid comprises the thrombus; and
iii. a collector tank (52) coupled to the aspirator (56) via an inlet duct (54) and coupled to the suction tube (50) at a port (52a) of the collector tank (52); the collector tank (52) is configured to collect the aspirated fluid ; and
c. an infusion unit (85) comprising:
i. a reservoir (80) holding an infusion fluid;
ii. an outlet duct (74) coupled to an outlet port of a casing (70) and configured to provide a passage for the infusion fluid; and
iii. an impeller (66) enclosed within the casing (70) and coupled to the motor (75); the impeller (66) is configured to generate a centrifugal suction force, in response to the rotation of the motor (75), driving the infusion fluid from the reservoir (80) into the outlet duct (74);
iv. wherein the outlet duct (74) is detachably coupled to a second catheter (76) having an infusion lumen providing passage to the infusion fluid to be delivered at the target site.
2. The medical device (100) as claimed in claim 1, wherein the aspirator (56) comprises:
a. a body (56a) having an opening at a proximal end; and
b. a piston (56b) coupled to a shaft (75a1) of the motor (75) via an eccentric sheave (75a2) and configured to move back-and-forth within the body (56a) in response to the rotation of the motor (75).
3. The medical device (100) as claimed in claim 2, wherein one end of the inlet duct (54) is coupled to a port (56a2) of the body (56a) and the other end of the inlet duct (54) is coupled to a floating chamber (54’’); the floating chamber (54’’) comprising a float concentrically disposed inside a frame at a mouth of the floating chamber (54’’), the float is configured to move upwards in response to contacting the aspirated fluid in the collector tank (52) and in response the aspirated fluid reaching a pre-defined height, the float is configured to block the other end of the inlet duct (54).
4. The medical device (100) as claimed in claim 1, wherein the aspiration unit (45) comprises a thrombus detection system configured to:
a. detect presence or absence of the thrombus;
b. in response to detecting the thrombus, automatically activate the aspiration unit (45); and
c. in response to detecting the absence of the thrombus or in response to detecting removal of the thrombus, automatically deactivate the aspirator (56).
5. The medical device (100) as claimed in claim 4, wherein the thrombus detection system comprises:
a. a first pressure sensor (40a) provided towards a distal end of the suction tube (50) and coupled to the suction tube (50);
b. a second pressure sensor (40b) provided towards a proximal end of the suction tube (50) and coupled to the suction tube (50), wherein the first pressure sensor (40a) and the second pressure sensor (40b) are configured to detect a pressure within the suction tube (50) at a respective location within the suction tube (50);
c. a pressure sensing unit (40) coupled to the first pressure sensor (40a) and the second pressure sensor (40b) and configured to receive electrical signals therefrom indicating respective sensed pressure; the pressure sensing unit (40) having a control unit configured to:
i. calculate a difference between the pressure sensed by the first pressure sensor (40a) and the second pressure sensor (40b)
ii. in response to the pressure sensed by the first pressure sensor (40a) being greater than the pressure sensed by the second pressure sensor (40b), activate the aspirator (56); and
iii. in response to the pressure sensed by the first pressure sensor (40a) being lower than the pressure sensed by the second pressure sensor (40b), deactivate the aspirator (56).
6. The medical device (100) as claimed in claim 5, wherein in response to the pressure sensed by the first pressure sensor (40a) being greater than the pressure sensed by the second pressure sensor (40b), the control unit of the pressure sensor unit (40) is configured to:
a. send a first control signal to a controller of a rectifier (14), causing the controller of the rectifier (14) to provide a second pre-defined voltage to the motor (75); and
b. send an electrical signal to a mechanical valve (40c) coupled to the suction tube (50), causing the mechanical valve (40c) to a fully open position;
c. wherein in response to receiving the second pre-defined voltage, the motor (75) rotates at a second pre-defined rotational speed, causing the aspirator (56) to generate the suction force, thereby activating the aspirator (56).
7. The medical device (100) as claimed in claim 6, wherein a control element (12) is coupled to the rectifier (14) and the motor (75), the control element (12) is manipulable to be in one of a plurality of MANUAL positions (12a4), wherein in response to the control element (12) being set to one of the MANUAL positions (12a4), the motor (75) rotates at a rotational speed greater than the second pre-defined rotational speed, thereby increasing the suction force generated by the aspirator (56).
8. The medical device (100) as claimed in claim 5, wherein in response to the pressure sensed by the first pressure sensor (40a) being lower than the pressure sensed by the second pressure sensor (40b), the control unit of the pressure sensor unit (40) is configured to:
a. send a second control signal to a controller of a rectifier (14), causing the controller of the rectifier (14) to provide a first pre-defined voltage to the motor (75); and
b. send an electrical signal to a mechanical valve (40c) coupled to the suction tube (50), causing the mechanical valve (40c) to a partially closed position;
c. wherein in response to receiving the first pre-defined voltage, the motor (75) rotates at a first pre-defined rotational speed, thereby deactivating the aspirator (56).
9. The medical device (100) as claimed in claim 5, wherein the pressure sensor unit (40) is decoupled from a rectifier (14) during the operation of the infusion unit (85).
10. The medical device (100) as claimed in claim 1, wherein the inlet duct (54) is decoupled from the collector tank (52) during the operation of the infusion unit (85).
11. The medical device (100) as claimed in claim 1, wherein the infusion unit (85) comprises:
a. a stopcock (68a) coupled to a hose (68) and configured to control flow of the infusion fluid from the reservoir (80) into the casing (70);
b. wherein the stopcock (68a) is opened during an operation of the infusion unit (85) and is closed during an operation of the aspiration unit (45).
12. The medical device (100) as claimed in claim 1, wherein the infusion unit (85) comprises:
a. a unidirectional duck valve (74b), coupled to the outlet duct (74), prevents backward flow of the infusion fluid;
b. an On-Off valve (74c) coupled to the outlet duct (74) and configured to control the flow of the infusion fluid; and
c. a filter element axially gripping the outlet port and configured to convert a turbulent flow of the infusion fluid into a laminar flow.
13. The medical device (100) as claimed in claim 1, wherein a control element (12) is coupled to a rectifier (14) and the motor (75), the control element (12) is manipulable to be in one of: an ON position (12a1), an OFF position (12a2); an AUTO position (12a3) and a plurality of MANUAL positions (12a4), wherein:
a. in response to the control element (12) being set to the ON position (12a1), the rectifier (14) provides a first pre-defined voltage to the motor (75), and the motor (75) rotates at a first pre-defined rotational speed;
b. in response to the control element (12) being set to the AUTO position (12a3), the rectifier (14) provides a second pre-defined voltage to the motor (75), and the motor (75) rotates at a second pre-defined rotational speed; and
c. in response to the control element (12) being set to one of the MANUAL positions (12a4), the rectifier (14) provides a voltage higher than the second pre-defined voltage to the motor (75), and the motor (75) to rotate at a rotational speed greater than the second pre-defined rotational speed.
14. The medical device (100) as claimed in claim 1, wherein a pressure gauge (16), coupled to the inlet duct (54) of the aspiration unit (45) and an outlet duct (74) of the infusion unit (85), is configured to measure pressure in the aspiration unit (45) and the infusion unit (85); the pressure gauge (16) comprising:
a. a pointer; and
b. a dial having a plurality of indicators corresponding to negative pressure values indicating pressure in the aspiration unit (45) and a plurality of indicators corresponding to positive pressure values indicating pressure in the infusion unit (85).