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:
THROMBECTOMY DEVICE

2. APPLICANTS:
Meril Life Sciences Pvt. Ltd., an Indian company, of the address Survey No. 135/139 Bilakhia House, Muktanand Marg, Chala, Vapi-Gujarat 396191

3. 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 device. More particularly, the present disclosure relates to a thrombectomy device.
BACKGROUND OF INVENTION
[2] In certain conditions, when a patient has a blood clot or thrombus in their veins and arteries, thrombectomy and aspiration of thrombus or blood clot is performed. Thrombectomy device is one such device which can perform this process.
[3] However, thrombectomy devices suffer from a number of drawbacks. For example, these devices come in a fixed dimension. When a thrombectomy device of one dimension is not compatible with dimension of the wall of vessels, the user needs to change the entire device during the surgery. This makes it very cumbersome for the user.
[4] Thus, there arises a need for a 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 invention relates to a thrombectomy device. In an embodiment, the thrombectomy device includes a motor, a pump, a transmission shaft, a wire and a control element. The motor includes a shaft. The pump includes an impeller detachably coupled to the motor. The transmission shaft, at partially disposed within a catheter shaft, is operatively coupled to the shaft of the motor. A proximal end of the wire is coupled to a proximal end of the transmission shaft. The wire is configurable to be in an open condition or a closed condition. The control element is coupled to the motor. The control element is configured either to be in a first position or a second position. In response to the control element being moved to the second position, the motor moves in a distal direction and couples with the impeller.
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 and Fig. 1a depict an exploded view of a device 100 in accordance with an embodiment of the present disclosure.
[9] Fig. 2a depicts an expanded view of a distal portion of the device 100 in a closed condition in accordance with an embodiment of the present disclosure.
[10] Fig. 2b depicts an expanded view of the distal portion of the device 100 in an open condition in accordance with an embodiment of the present disclosure.
[11] Fig. 3 depicts an expanded view of an impeller shaft 113e and a transmission shaft 115 of the device 100 in accordance with an embodiment of the present disclosure.
[12] Fig. 4a1 depicts an isometric view of the impeller shaft 113e in a disconnected state, in accordance with an embodiment of the present disclosure.
[13] Fig. 4a2 depicts a side view of the impeller shaft 113e in the disconnected state, in accordance with an embodiment of the present disclosure.
[14] Fig. 4b1 depicts an isometric of the impeller shaft 113e in a connected state in accordance with an embodiment of the present disclosure.
[15] Fig. 4b2 depicts a side view of the impeller shaft 113e in the connected state in accordance with an embodiment of the present disclosure.
[16] Fig. 4c1 depicts a coupling of the impeller shaft 113e with an inlet port 113c in accordance with an embodiment of the present disclosure.
[17] Fig. 4c2 depicts an expanded view of a proximal portion of the inlet port 113c in accordance with an embodiment of the present disclosure.
[18] Fig. 5 depicts a side view of a separator 160 in accordance with an embodiment of the present disclosure.
[19] Fig. 5a depicts a front perspective view of the separator 160 in accordance with an embodiment of the present disclosure.
[20] Fig. 5b depicts a back perspective view of the separator 160 in accordance with an embodiment of the present disclosure.
[21] Fig. 6 depicts a side view of the device 100 in a first mode in accordance with an embodiment of the present disclosure.
[22] Fig. 6a depicts a side view of the device 100 in a second mode in accordance with an embodiment of the present disclosure.
[23] Fig. 7 illustrates a flowchart of a method 700 of operating the device 100, in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE DRAWINGS
[24] Prior to describing the disclosure 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.
[25] 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.
[26] 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.
[27] 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.
[28] The present disclosure encloses a thrombectomy device (hereinafter, interchangeably referred to as ‘device’). In an embodiment, the device includes an aspiration unit (including a pump) integrated with the device. Hence, the device has a capability to break the thrombus as well as aspirate the thrombus. The device includes a motor coupled to the pump and a transmission shaft and is configured to drive the pump and the transmission shaft. The transmission shaft may be disposed in a catheter shaft and coupled to a wire (such as a thrombectomy wire).
[29] In an embodiment, the device includes a detachable coupling element configured to detach the motor and the pump from the transmission shaft. This allows the user to couple and decouple the transmission shaft and the catheter shaft as and when required. In an embodiment, the detachable coupling element can be coupled with the transmission shaft using a press-fit mechanism.
[30] The proposed device is more convenient to use. The user does not need to replace the entire device including the motor and the pump when a medical procedure requires a different catheter shaft or a different wire (based upon for example, vessel size or type of thrombus) unlike conventional devices. The user can simply detach one transmission shaft from the motor and the pump and attach a different transmission shaft to the motor and the pump. This also makes manufacturing of the proposed device more efficient and less expensive. Further, the press-fit mechanism enables the user to employ minimal force to decouple the transmission shaft from the motor and the pump.
[31] In an embodiment, the pump is detachably coupled to the motor such that the pump can be coupled to the motor when needed, for example, while aspirating the thrombus and can be decoupled from the motor otherwise, for example, while breaking the thrombus. This prevents unnecessary aspiration of blood while performing the medical procedure. Hence, the proposed device reduces blood loss in the patient during the medical procedure and improves outcome for the patient. The proposed device also allows controlling the speed of the pump, thereby, the rate of aspiration. This also reduces the amount of undesired blood loss.
[32] Now referring to the figures, Fig. 1 shows an exploded view of a thrombectomy device 100 (or a device 100) according to an embodiment. Assembled views of the device 100 during an operation of the device 100 are depicted in Fig. 6 and Fig. 6a. The device 100 includes a proximal end 100a and a distal end 100b. The device 100 includes a motor 110, a motor casing 120, a control element 111, a rectifier 119, a pump 113, a transmission shaft 115, a wire 117, a hemostasis hub 130, a catheter shaft 150 and a battery casing 140. Fig. 1a shows an exploded view of various components of the device 100 at the proximal end 100a according to an embodiment.
[33] The motor 110 includes a proximal end and a distal end. In an embodiment, the motor 110 is a DC motor. In an exemplary implementation, the motor 110 is a brushless DC (BLDC) motor. The motor 110 is used to power the transmission shaft 115 and an impeller 113b. The motor 110 may have power rating ranging from 1W to 3W. In an exemplary embodiment, motor 110 has power rating of 2W.
[34] The motor 110 includes a shaft 110b (as shown in Fig. 1). Outer body of the motor 110 protects windings, bearings, and other mechanical parts of the motor 110 from moisture, chemicals, mechanical damage and abrasion from grit.
[35] The shaft 110b provides torque to the transmission shaft 115 and an impeller shaft 113e of the pump 113. The shaft 110b may be made of material including without limitation, stainless steel, cold rolled steel, hot rolled steel, mild steel, etc. In an exemplary embodiment, the shaft 110b is made of stainless steel.
[36] At the proximal end of the motor 110, the rectifier 119 is coupled to the motor 110. The rectifier 119 converts AC power received from an AC supply (not shown) of the device 100 to DC power suitable for the motor 110. The rectifier 119 may also regulate DC voltage supplied to the motor 110 so that the motor 110 stays at a safe level. Further, the rectifier 119 may include a battery management system (BMS) circuit to deliver targeted range of voltage and current for a duration of time against expected load scenarios. The rectifier 119 may be designed such that the motor 110 can run on the AC power when the AC supply is connected to the rectifier 119 and can charge batteries in a battery pack 140a inside the battery casing 140 using the AC supply.
[37] The control element 111 is configured to be in a first position or a second position. In an example implementation, the control element 111 is said to be in the first position when the control element 111 is moved in a proximal direction (e.g., by the user) and the control element 111 is said to be in the second position when the control element 111 is moved in a distal direction (e.g., by the user). Further, the control element 111 is coupled to the motor 110 such that when the control element 111 is moved to the first position, the motor 110 moves in the proximal direction in response to the movement of control element 111 and when the control element 111 is moved to the second position, the motor 110 moves in the distal direction in response to the movement of control element 111. A user may grip the control element 111 and move the control element 111 in the first position and the second position.
[38] In an embodiment, the control element 111 includes a shifter case 111c. The shifter case 111c enables the user to move the motor 110 in the proximal and the distal direction. The shifter case 111c has a cylindrical shape. The shifter case 111c is disposed around a portion of the motor 110 and is fixedly coupled with the motor 110 such that when the shifter case 111c is moved to the first position, the motor 110 moves in the proximal direction and when the shifter case 111c is move to the second position, the motor 110 moves in the distal direction. The shifter case 111c may be fixedly coupled to the motor 110 using adhesive, bonding, snap fit mechanism, or any other suitable technique. In an embodiment, the shifter case 111c is coupled to the motor 110 using adhesive. The shifter case 111c includes a cylindrical protrusion at a lateral side of the shifter case 111c. The shifter case 111c may be made of material including, but not limited to, polycarbonate, acrylonitrile butadiene styrene, etc. In an exemplary embodiment, shifter case 111c is made of acrylonitrile butadiene styrene.
[39] The control element 111 is configured to turn the motor 110 ON or OFF. In an embodiment, the control element 111 includes a push button 111a to turn the motor 110 ON or OFF. The push button 111a includes a disc portion and a stem portion. The stem portion of the push button 111a of the control element 111 is disposed within the cylindrical protrusion of the shifter case 111c. The push button 111a is electrically coupled to the motor 110 using, for example, electrical cables. The push button 111a is pressed to switch ON the motor 110. In an embodiment, the user may need to keep the push button 111a pressed to keep the motor turned ON. The motor 110 can be turned OFF by releasing the push button 111a.
[40] The control element 111 is configured to control a speed of the motor 110 and thereby, the speed of the impeller 113b. In an embodiment, the control element 111 includes a dimmer 111b disposed on the disc portion of the push button 111a. The dimmer 111b includes a rotating knob, which is rotated to control the speed of the motor 110. In an embodiment, the dimmer 111b is configured to be set to a plurality of speed positions to control the speed of the motor 110. In another embodiment, instead of discrete speed positions, the dimmer 111b may be rotated in a continuous manner and based upon the position of the dimmer 111b, the speed of the motor 110 is controlled. In an exemplary implementation, the dimmer 111b may be rotated clockwise to increase the speed of the motor 110 and rotated anti-clockwise to decrease the speed of the motor 110. The dimmer 111b is electrically coupled to the motor 110 using, for example, electrical cables.
[41] The motor casing 120 is disposed at the proximal end 100a. As shown in Fig. 1a, the motor casing 120 includes a proximal end 120b and a distal end 120a. Motor casing 120 may be made of material, including, but not limited to, polycarbonate, acrylonitrile butadiene styrene, etc. In an exemplary embodiment, motor casing 120 is made of acrylonitrile butadiene styrene. In an exemplary embodiment, the motor casing 120 has a tubular structure and defines a cavity. The motor casing 120 houses the motor 110 in the cavity. The motor casing 120 includes a cut-out 120c on a lateral side of the motor casing 120 to receive the control element 111. The cut-out 120c has suitable dimensions to allow the control element 111 to be toggled between the first position or the second position. For example, the control element 111 is disposed towards a proximal end of the cut-out 120c when the control element 111 is in the first position and the control element 111 is disposed towards a distal end of the cut-out 120c when the control element 111 is in the second position.
[42] The pump 113 has a proximal end and a distal end. As shown in Fig. 1a, the pump 113 includes a pump casing 113a, an impeller 113b, an inlet port 113c, an outlet port 113d, and an impeller shaft 113e. In an exemplary embodiment, the pump 113 is a centrifugal pump.
[43] The inlet port 113c is disposed at the distal end of the pump 113, according to an embodiment, and may be co-axial with a central axis of the pump 113. In one embodiment, the inlet port 113c is operationally coupled to the hemostasis hub 130 to receive the thrombus’ debris or blood into the pump 113.
[44] The outlet port 113d is disposed laterally on the pump casing 113a, according to an embodiment. The outlet port 113d includes a duck valve (not shown). The duck valve helps in reducing the blood loss by preventing the blood leakage. When high pressure is developed by the pump 113, the duck valve opens, allowing the outlet port 113d to remove the thrombus’ debris or blood. The outlet port 113d removes the thrombus’ debris or blood collected in the pump 113 into a reservoir (not shown).
[45] In an exemplary embodiment, the impeller 113b is disposed inside the pump casing 113a. The impeller 113b is a rotating component of the pump 113 that accelerates fluid and thus, transfers energy from the motor 110 to the fluid that is being pumped. The impeller 113b includes a plurality of blades coupled axially to a hub. The impeller 113b is detachably coupled to the motor 110. Upon coupling the impeller 113b with the motor 110, the impeller 113b is configured to rotate when the shaft 110b rotates as the torque of the shaft 110b is transferred to the impeller 113b. The rotation of the impeller 113b generates a centrifugal force on the collected thrombus’ debris or the blood, causing the collected thrombus’ debris or the blood to be pushed out from the outlet port 113d. Upon decoupling the impeller 113b from the motor 110, the torque of the shaft 110b is not transferred to the impeller 113b and the impeller 113b does not rotate even when the shaft 110b rotates.
[46] In an embodiment, the impeller shaft 113e has a proximal end and a distal end. As shown in Fig. 3, at the proximal end of the impeller shaft 113e, the impeller shaft 113e includes a connecting element 113e1. The connecting element 113e1 is coupled to the shaft 110b. For example, the connecting element 113e1 includes an opening 113e4 at a proximal end of the connecting element 113e1. The opening 113e4 of the connecting element 113e1 is configured to receive a distal portion of the shaft 110b. The shape and dimensions of the opening 113e4 of the connecting element 113e1 corresponds to the shape and dimensions of the shaft 110b to provide a tight coupling. In an embodiment, the connecting element 113e1 has a tubular structure and includes a taper portion at a distal end of the connecting element 113e1 as shown in Fig. 3. The impeller 113b is detachably coupled to the motor 110 as explained below. The impeller 113b includes a cavity 113b1 (shown in Figs. 4a2 and 4b2) within the hub of the impeller 113b. The cavity 113b1 extends from the proximal end of the impeller 113b towards a central region of the hub. The cavity 113b1 is cylindrical in shape and has a taper at a distal end of the cavity 113b1. The dimensions and shape of the cavity 113b1 (including the taper) corresponds to the dimensions and shape of the connecting element 113e1.
[47] The cavity 113b1 includes a bearing (not shown). The bearing can be a mechanical ball bearing, a magnetically levitated bearing or any other suitable bearing. The bearing is used to support the impeller 113b over the connecting element 113e1 of the impeller shaft 113e. The bearing also helps in the movement of the impeller 113b in a forward direction (up to a distal limit of pump casing 113a) and in a backward direction (up to the proximal limit of the pump casing 113a). The bearing also ensures minimum mechanical wear and tear to the impeller 113b and the connecting element 113e1 due to the friction between the impeller 113b and the connecting element 113e1.
[48] In an exemplary embodiment, when the control element 111 is moved to the second position, the taper portion of the connecting element 113e1 of the impeller shaft 113e moves in a distal direction and engages the taper of the cavity 113b1 of impeller 113b, thereby coupling the shaft 110b and hence, the motor 110 with the impeller 113b (as shown in Fig. 4b1 and Fig. 4b2). When control element 111 is moved to the first position, the taper portion of the connecting element 113e1 of impeller shaft 113e moves in a proximal direction and disengages from the taper of the cavity 113b1 (as shown in Fig. 4a1 and Fig. 4a2), thereby disengaging the shaft 110b and hence, the motor 110 from the impeller 113b.
[49] When the taper portion of the connecting element 113e1 moves in the distal direction to engage with the taper of the cavity 113b1, the impeller 113b too moves slightly in the distal direction. The inlet port 113c includes a mechanism to restrict the movement of the impeller 113b in the distal direction. For example, a proximal portion of the inlet port 113c includes a support rod 113c1 (as shown in Figs. 4c1-4c2) provided diagonally. The support rod 113c1 includes a ring 113c2 disposed centrally on the support rod 113c1. The ring 113c2 includes a hole providing a passage for the impeller shaft 113e. The diameter of the ring 113c2 corresponds to the diameter of the impeller shaft 113e. The ring 113c2 includes two rods 113c3 extending from the ring 113c2 in a proximal direction. Each rod includes a roller 113c4 coupled to the rod 113c3 at a proximal end of the rod 113c3. The rollers 113c4restrict the movement of the impeller 113b in the distal direction. The rollers 113c4 also support the impeller 113b when the control element 111 moves to the second position.
[50] As the impeller 113b is detachably coupled to the motor 110, the pump 113 can be activated only when the thrombus is to be aspirated. When aspiration is not needed, the pump 113 can be deactivated by removing the coupling between the motor 110 and the impeller 113b. Hence, blood loss during the medical procedure can be reduced, thereby improving the outcome for the patient.
[51] In an embodiment, the shaft 110b of the motor 110 is operatively coupled to the transmission shaft 115 via impeller shaft 113e. The transmission shaft 115 is detachably coupled to the impeller shaft 113e using, for example, carabiner clip mechanism, threading mechanism, a press-fit mechanism, etc. In the depicted embodiment, the impeller shaft 113e is detachably coupled to the transmission shaft 115 using a press-fit mechanism. In an exemplary implementation, the impeller shaft 113e includes a groove 113e2 at a distal end of the impeller shaft 113e as shown in Fig. 3. The groove 113e2 fits within a corresponding cavity of the transmission shaft 115 to detachably couple the impeller shaft 113e and the motor 110 with the transmission shaft 115. In an embodiment, the groove 113e2 has a rectangular shape, though the groove 113e2 may have any other suitable shape. The impeller shaft 113e may also include two or more hemispherical balls 113e3 protruding out from an outer surface of the impeller shaft 113e. In an embodiment, the impeller shaft 113e includes two hemispherical balls 113e3 disposed on opposite ends on the outer surface of the groove 113e2 of the impeller shaft 113e. The two or more hemispherical balls 113e3 help to provide a tight fit between the impeller shaft 113e and the transmission shaft 115.irection and the motor rotation will be in the same direction when viewed from a single direction.d and b
[52] The pump casing 113a encloses the impeller 113b. The pump casing 113a of the pump 113 may be coupled to the motor casing 120. In an exemplary embodiment, the motor casing 120 and the pump casing 113a are formed as an integral structure. Pump casing 113a may be made of material including, but not limited to, polycarbonate, acrylonitrile butadiene styrene, titanium, stainless steel, aluminum, etc. In an exemplary embodiment, pump casing 113a is made of stainless steel. In an exemplary embodiment, the pump casing 113a has a disc shape structure and defines a cavity. The pump casing 113a houses the impeller 113b in the cavity.
[53] The pump casing 113a includes a hydrodynamic sealing at its proximal end where the shaft 110b of the motor 110 enters the pump casing 113a. The hydrodynamic sealing restricts the fluid from coming out of the pump casing 113a and reaching the electrical components (e.g., the motor 110, the battery pack 140a in the battery casing 140) at the proximal end. In an embodiment, the hydrodynamic sealing is a radial seal.
[54] The transmission shaft 115 includes a proximal end and a distal end. The transmission shaft 115 may include a connecting element 115a at the proximal end of the transmission shaft 115. The transmission shaft 115 includes a cylindrical cavity (not shown) from the distal end of the transmission shaft 115 to the proximal end of the transmission shaft 115. In an embodiment, the cylindrical cavity receives at least a portion of the wire 117. The proximal end of the transmission shaft 115 is coupled with the proximal end of wire 117.
[55] The transmission shaft 115 is configured to be detachably coupled with the impeller 113b and the motor 110 via the impeller shaft 113e and the connecting element 115a using, for example, a press-fit mechanism. As shown in Fig. 3, the connecting element 115a has a tubular shape. In an embodiment, the connecting element 115a has a cavity 115a1. The shape of the cavity 115a1 corresponds to the shape of the groove 113e2. In an example implementation, the cavity 115a1 is rectangular in shape. The connecting element 115a may also include two or more holes 115a2 at the proximal end of the connecting element 115a. In an embodiment, the connecting element 115a includes two holes 115a2 disposed on opposite ends of the cavity 115a1. The dimensions of the two or more holes 115a2 correspond to the dimensions of the two or more hemispherical balls 113e3. The two or more holes 115a2 help to provide a tight fit between the transmission shaft 115 and the impeller shaft 113e.
[56] The detachable coupling of the motor 110 and the impeller 113b with the transmission shaft 115 as disclosed, enables the user to change a catheter (e.g., its size) based upon requirement without changing the entire device 100. During a medical procedure, if a catheter of a different size needs to be used, the user can simply detach a transmission shaft of a first catheter (or a first size, e.g., 6 Fr.) from the motor 110 and the impeller 113b and attach a transmission shaft of a second catheter (of a second size, e.g., 4 Fr.). This improves usability and saves time during the medical procedure.
[57] The transmission shaft 115 may be made of a material, without limitation, nitinol, stainless steel, etc. In an exemplary embodiment, the transmission shaft 115 is made of stainless steel.
[58] The wire 117 includes a proximal end and a distal end. The wire 117 is disposed at least partially within the cylindrical cavity of the transmission shaft 115. The proximal end of the wire 117 is coupled with the proximal end of the transmission shaft 115. In an embodiment, at least a partial length of the wire 117 extends from the distal end of the transmission shaft 115 towards the distal end 100b of the device 100. The wire 117 includes a distal portion 117b.
[59] The transmission shaft 115 transfers the torque provided by the motor 110 to the wire 117 for breaking the thrombus or blood clot. The transmission shaft 115 is operationally coupled with the shaft 110b of the motor 110 via the impeller shaft 113e.
[60] In an embodiment, the wire 117 is a thrombectomy wire. According to an exemplary embodiment, the distal portion 117b of the wire 117 has a sinusoidal shape. It should be appreciated that the distal portion 117b of the wire 117 may have any other shape suitable for breaking the thrombus. In an embodiment, the wire 117 includes a soft tip 117a at the distal end of the wire 117. The soft tip 117a reduces trauma while navigating the wire 117 and during the medical procedure. When the transmission shaft 115 rotates, wire 117 is configured to rotate and break the thrombus or the blood clot.
[61] Referring to Fig. 1, the catheter shaft 150 includes a proximal end and a distal end. The proximal end of catheter shaft 150 is coupled with the hemostasis hub 130. In an embodiment, the catheter shaft 150 is a multi-lumen shaft including at least two lumens. In an embodiment, the catheter shaft 150 includes an aspiration lumen 150a and a transmission lumen 150b. The aspiration lumen 150a facilitates the collection of de-clotted blood from blood vessels. The transmission lumen 150b houses the transmission shaft 115 and the wire 117. In an embodiment, the transmission shaft 115 and the wire 117 are disposed partially within the transmission lumen 150b of the catheter shaft 150.
[62] The catheter shaft 150 is tubular in shape. The catheter shaft 150 may be made of material including, without limitation, polytetrafluoroethylene (PTFE), polyether-block-amide (PEBAX), nylon, etc. In an exemplary embodiment, the catheter shaft 150 is made of polyether-block-amide (PEBAX).
[63] During operation of the device 100, the wire 117 may be in an open condition or a closed condition. Fig. 2a shows the wire 117 in the close condition. In the close condition, the soft tip 117a may be extending out from the distal end of the catheter shaft 150 as shown, according to an embodiment. The wire 117 may be configured to be in the close condition while advancing the catheter shaft 150 to a target site or removing the catheter shaft 150 from the target site. Fig. 2b shows the wire 117 in the open condition. In the open condition, the distal portion 117b of the wire 117 extends out from the distal end of the catheter shaft 150 as shown. The wire 117 may be configured to be in the open condition while breaking the thrombus and aspirating the thrombus.
[64] Referring to Fig. 1, the hemostasis hub 130 has a proximal end and a distal end. The distal end of the hemostasis hub 130 is coupled to the proximal end of the catheter shaft 150. The hemostasis hub 130 helps in reducing the blood loss in the patient during the medical procedure.
[65] The hemostasis hub 130 has a tubular structure. The hemostasis hub 130 includes a hemostasis valve (not shown) provided at the proximal end of the hemostasis hub 130, a tube 130a, coupled laterally at the surface of hemostasis hub 130 and a 3-way stopcock 130a1 coupled at a distal end of tube 130a. The tube 130a may also serve as a medium to supply medicine or any infused agent during the medical procedure.
[66] The device 100 further includes a separator 160. The separator 160 is detachably coupled to the transmission shaft 115. The separator 160 has a proximal end and a distal end. Figs. 5 – 5b depicts various views of the separator 160 according to an embodiment. The separator 160 includes two jaws 160a and 160b disposed along the longitudinal axis of the separator 160. The jaws 160a and 160b are coupled to a resilient element 160d (as shown in Fig. 5b) provided on a lateral side of the separator 160. The jaw 160a includes at least one grip 160a1 and a slot 160a2. Similarly, the jaw 160b includes at least one grip 160b1 and a slot 160b2. The grips 160a1 and 160b1 are used to open and close the jaws 160a and 160b of the separator 160. The jaws 160a and 160b can be opened by applying a pressure on the grips 160a1 and 160b1. When the pressure on the grips 160a1 and 160b1 is removed, the resilient element 160d applies a resilient force and the jaws 160a and 160b are closed. In an embodiment, the resilient element 160d is a torsion spring. The slots 160a2 and 160b2 are semi-circular and have dimensions such that when closed the slots 160a2 and 160b2 form a lumen to hold the transmission shaft 115. The separator 160 may include a coupling element 160c for coupling the separator 160 with the hemostasis hub 130. The coupling element 160c may be an elastic rope or a rope wire. While advancing the catheter shaft 150 through the vasculature to the target site or while removing the catheter shaft 150 through the vasculature, the separator 160 is inserted between the pump 113 and the hemostasis hub 130. The jaws 160a and 160b are opened by applying a force on the grips 160a1 and 160b1. The slots 160a2 and 160b2 are aligned with the transmission shaft 115. The force on the grips 160a1 and 160b1 is then released so that the separator 160 holds the transmission shaft 115 between the slots 160a2 and 160b2. Inserting the separator 160 between the pump 113 and the hemostasis hub 130 separates the inlet port 113c of the pump 113 and an outer sheath of the catheter shaft 150. As a result, the outer sheath of the catheter shaft 150 covers the distal portion 117b of the wire 117. Consequently, the wire 117 is in the close condition as desired when the catheter shaft 150 is being advanced or removed through the vasculature (as shown in Fig. 6).
[67] When the catheter shaft 150 reaches the target site, the separator 160 is decoupled. The separator 160 can be decoupled by applying a force on the grips 160a1 and 160b1 to open the jaws 160a and 160b. The separator 160 is then moved so that the separator 160 no longer holds the transmission shaft 115 and the force on the grips 160a1 and 160b1 is released. The inlet port 113c is then inserted into the hemostasis hub 130. As there is no extra separation between the inlet port 113c and the outer sheath of the catheter shaft 150, the outer sheath retracts over the wire 117, thereby moving the wire 117 to the open condition as desired (as shown in Fig. 6a).
[68] Referring to Fig. 1, the battery casing 140 is disposed at the proximal end 100a of the device 100. The battery casing 140 may include a battery pack 140a having at least one battery 140b. The at least one battery 140b may be of a type such as, but not limited to lithium-ion, nickel-cadmium, alkaline, etc. In an exemplary embodiment, the at least one battery 140b is lithium-ion battery. The at least one battery 140b is coupled to the motor 110 to provide power supply to the motor 110. Thus, the device 100 can also function as a portable device powered by the at least one battery 140b.
[69] During the operation of the device 100, the device 100 is configured to be in a first mode or a second mode. The device 100 is configured to be in the first mode during navigating the catheter shaft 150 to a target position. The device 100 is configured to be in the second mode during breaking the thrombus/the blood clot and/or aspirating the thrombus/the blood clot. In the first mode (as shown in Fig. 6), the transmission shaft 115 is coupled to impeller shaft 113e. The control element 111 is in the first position and the motor 110 is OFF. Consequently, the impeller 113b is decoupled from the motor 110. Further, the proximal end of the separator 160 is coupled to the inlet port 113c of the pump 113 and the distal end of the separator 160 is coupled to the proximal end of the hemostasis hub 130. Thus, the separator 160 separates the pump 113 and the hemostasis hub 130 in the first mode. Further, the wire 117 is in the close condition (as shown in Fig. 2a).
[70] In the second mode (as shown in Fig. 6a), the transmission shaft 115 remains coupled to the impeller shaft 113e. The separator 160 is decoupled from the inlet port 113c of the pump 113. The proximal end of the hemostasis hub 130 is coupled to the inlet port 113c. For example, a distal end of the inlet port 113c is inserted into hemostasis hub 130 through the proximal end of the hemostasis hub 130. The hemostasis valve is stretched and coupled to the distal end of the inlet port 113c such that the hemostasis valve and inlet port 113c form a leak proof setup. Now, the wire 117 is in the open condition. Thus, the device 100 is ready to break the thrombus. The motor 110 is switched ON using the control element 111 (e.g., by pressing the push button 111a of the control element 111). The torque from the motor 110 is transferred to the wire 117 via the shaft 110b, the impeller shaft 113e and the transmission shaft 115. The wire 117 breaks the thrombus. To aspirate the thrombus, the motor 110 is moved to the second position using the control element 111 (e.g., using the shifter case 111c), thereby coupling the motor 110 with the impeller 113b. The rotation of the impeller 113b generates a suction force to aspirate the thrombus from the inlet port 113c to the outlet port 113d. The speed of the motor 110 and thereby, the speed of the impeller 113b can be controlled using the control element 111 (e.g., via the dimmer 111b of the control element 111). Once desired aspiration is achieved, the impeller 113b can be disengaged from the motor 110 by moving the motor 110 to the first position using the control element 111 (e.g., using the shifter case 111c). After completing the medical procedure, the motor 110 is switched OFF using the control element 111 (e.g., by releasing the push button 111a of the control element 111).
[71] Fig. 7 illustrates a flowchart of a method 700 for operating the device 100 during a medical procedure, according to an embodiment.
[72] At step 701, the transmission shaft 115 is coupled to the impeller shaft 113e. The transmission shaft 115 (and the wire 117) is a transmission shaft (and a wire) suitable for a target vasculature of the medical procedure. The transmission shaft 115 and the impeller shaft 113e are coupled (e.g., by press-fitting) so that the groove 113e2 of the impeller shaft 113e is pushed inside the cavity 115a1 of the connecting element 115a of the transmission shaft 115. Further, each hole 115a2 of the two or more holes 115a2 on the connecting element 115a receive a corresponding hemispherical ball 113e3 of the two or more h1emispherical balls 113e3 thereby locking the transmission shaft 115 and impeller shaft 113e.
[73] At step 702, the separator 160 is coupled with the transmission shaft 115 between hemostasis hub 130 and the inlet port 113c, as explained earlier. Further, the shifter case 111c of the control element 111 is kept in the first position and the push button 111a of the control element 111 is not pressed, thereby having the motor 110 in OFF state. The wire 117 is in the close condition. Thus, the device 100 is in the first mode (as shown in Fig. 6). In addition, the duck valve coupled to the outlet port 113d and the 3-way stopcock 130a1 are closed.
[74] At step 703, the catheter shaft 150 is advanced through the vasculature to a target site.
[75] At step 704, the separator 160 is decoupled from the transmission shaft 115 once the catheter shaft 150 reaches the target site.
[76] At step 705, the inlet port 113c of the pump 113 is coupled to the hemostasis hub 130. The inlet port 113c of the pump 113 can be coupled to the hemostasis hub 130 by gently stretching the hemostasis valve and coupling to the inlet port 113c of the pump 113. Further, the wire 117 is moved to the open condition. The wire 117 can be moved to the open condition by sliding the pump 113 towards an outer sheath of the catheter shaft 150 while holding the outer sheath. The wire 117 can also be moved to the open condition by sliding the outer sheath towards the pump 113 while holding the pump 113. Thus, the device 100 is now in the second mode (as shown in Fig. 6a).
[77] At step 706, the push button 111a of the control element 111 is pressed to operate the wire 117 to break the thrombus. By pressing the push button 111a of the control element 111, the motor 110 is switched ON and provides torque to the wire 117. As a result, the wire 117 rotates. The thrombus is broken by the rotation of the wire 117. The dimmer 111b of the control element 111 may be rotated clockwise to increase the speed of the motor 110 and thereby, the rotational speed of the wire 117. The dimmer 111b of the control element 111 may be rotated anti-clockwise to decrease the speed of the motor 110, and thereby, the rotational speed of the wire 117.
[78] At step 707, the control element 111 is moved to the second position, if aspirating the thrombus is needed. The user may grip the control element 111, e.g., the push button 111a and pushed the push button 111a forward to the second position, thereby moving the shifter case 111c of the control element 111 to the second position. As a result, the motor 110 moves in the distal direction and the connecting element 113e1 engages the cavity 113b1. This causes the motor 110 to be coupled to the impeller 113b and the plurality of blades begin to rotate. The rotation of the plurality of blades generates a suction force so as to aspirate the thrombus. The reservoir is coupled to the outlet port 113d. Due to the pressure developed within the pump 113, the duck valve is opened and the aspirated thrombus is dropped into the reservoir. If infusion of an infusion agent is required (for example, to loosen hardened thrombus), the 3-way stopcock 130a1 can be opened and the infusion agent is infused via the tube 130a.
[79] At step 708, once the breakage and aspiration of the thrombus is complete, the control element 111 is moved to the first position using the shifter case 111c. This causes the motor 110 to be decoupled from the impeller 113b and the impeller 113b stops. The motor 110 is switched OFF by releasing the push button 111a. Further, the duck valve coupled to the outlet port 113d is closed.
[80] At step 709, the separator 160 is coupled between the hemostasis hub 130 and the pump 113 as explains earlier. As a result, the wire 117 is in the close condition. Thus, the device 100 is in the first mode (as shown in Fig. 6).
[81] At step 710, the catheter shaft 150 is removed from the vasculature.
[82] 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 thrombectomy device (100) comprising:
a. a motor (110) comprising a shaft (110b);
b. a pump (113) comprising an impeller (113b) detachably coupled with the motor (110);
c. a transmission shaft (115) operatively coupled to the shaft (110b) and at least partially disposed in a catheter shaft (150);
d. a wire (117) having a proximal end coupled to a proximal end of the transmission shaft (115) and configurable to be in an open condition or a closed condition; and
e. a control element (111) coupled to the motor (110) and configurable to be in a first position or a second position;
f. wherein, in response to the control element (111) being moved to the second position, the motor (110) moves in a distal direction and couples with the impeller (113b).
2. The thrombectomy device (100) as claimed in claim 1, wherein the pump (113) comprises an impeller shaft (113e) coupled with the shaft (110b) at a proximal end of the impeller shaft (113e) and with the transmission shaft (115) at a distal end of the impeller shaft (113e); the impeller shaft (113e) is detachably coupled with the impeller (113b), wherein in response to the control element (111) being moved to the second position, the impeller shaft (113e) moves in the distal direction and coupled with the impeller (113b), thereby coupling the motor (110) with the impeller (113b).
3. The thrombectomy device (100) as claimed in claim 2, wherein the impeller shaft (113e) comprises a connecting element (113e1) having a taper portion configured to engage with a taper portion of a cavity (113b1) of the impeller (113b), in response to the impeller shaft (113e) moving in the distal direction, thereby coupling the impeller shaft (113e) with the impeller (113b).
4. The thrombectomy device (100) as claimed in claim 3, wherein the cavity (113b1) comprises a bearing configured to support the impeller (113b) over the connecting element (113e1).
5. The thrombectomy device (100) as claimed in claim 3, wherein the connecting element (113e1) comprises an opening (113e4) configured to receive a distal end of the shaft (110b).
6. The thrombectomy device (100) as claimed in claim 2, wherein the transmission shaft (115) is removably coupled with the impeller shaft (113e).
7. The thrombectomy device (100) as claimed in claim 6, wherein the transmission shaft (115) comprises a connecting element (115a), at a proximal end of the transmission shaft (115), having a cavity (115a1), wherein the impeller shaft (113e) comprises a groove (113e2), provided at the distal end of the impeller shaft (113e), configured to fit in the cavity (115a1).
8. The thrombectomy device (100) as claimed in claim 7, wherein the impeller shaft (113e) comprises hemispherical balls (113e3) disposed on opposite ends on an outer surface of the groove (113e2) and configured to fit in corresponding holes (115a2) disposed on opposite ends of the cavity (115a1).
9. The thrombectomy device (100) as claimed in claim 1, wherein the thrombectomy device (100) comprises a motor casing (120) housing the motor (110) in a cavity of the motor casing (120) and having a cut-out (120c), wherein, in the first position, the control element (111) is disposed towards a proximal end of the cut-out (120c) and, in the second position, the control element (111) is disposed towards a distal end of the cut-out (120c).
10. The thrombectomy device (100) as claimed in claim 1, wherein the pump (113) includes a pump casing (113a) enclosing the impeller (113b) and having an outlet port (113d) disposed laterally on the pump casing (113a).
11. The thrombectomy device (100) as claimed in claim 1, wherein the control element (111) comprises:
a. a shifter case (111c) fixedly coupled to the motor (110) and configured to move the motor (110) in the first position or the second position, the shifter case (111c) comprising a cylindrical protrusion on a lateral side of the shifter case (111c);
b. a push button (111a) electrically coupled to the motor (110) and configured to switch the motor (110) ON and OFF, the push button (111a) comprising a disc portion and a stem portion disposed within the cylindrical protrusion of the shifter case (111c); and
c. a dimmer (111b) disposed on the disc portion of the push button (111a) and electrically coupled to the motor (110); the dimmer (111b) is configured to control speed of the motor (110).
12. The thrombectomy device (100) as claimed in claim 1, wherein in a first mode, a separator (160) is disposed between a distal end of an inlet port (113c) of the pump (113) and a proximal end of a hemostasis hub (130), and coupled to a portion of the transmission shaft (115), thereby configuring the wire (117) to be in the closed condition.
13. The thrombectomy device (100) as claimed in claim 12, wherein the separator (160) comprises:
a. jaws (160a, 160b) disposed along a longitudinal axis of the separator (160), each jaw (160a, 160b) of the jaws (160a, 160b) comprising a grip (160a1, 160b1) and a slot (160a2, 160b2), the jaws (160a, 160b) are configured to open in response to applying pressure on the respective grip (160a1, 160b1);
b. a resilient element (160d) coupled with the jaws (160a, 160b) and configured to apply a resilient force on the jaws (160a, 160b) in response to releasing the pressure on the respective grip (160a1, 160b1);
c. wherein the slots (160a2, 160b2) form a lumen configured to hold a portion of the transmission shaft (115).
14. The thrombectomy device (100) as claimed in claim 13, wherein the separator (160) comprises a coupling element (160c) for coupling the separator (160) with the hemostasis hub (130).
15. The thrombectomy device (100) as claimed in claim 1, wherein in a second mode, a distal end of an inlet port (113c) of the pump (113) is coupled with a hemostasis valve provided at a proximal end of a hemostasis hub (130), thereby configuring the wire (117) to be in the open condition.
16. The thrombectomy device (100) as claimed in claim 1, wherein a proximal portion of the inlet port (113c) includes a support rod (113c1) which restricts the movement of the impeller (113b) in the distal direction.
17. The thrombectomy device (100) as claimed in claim 1, wherein the thrombectomy device (100) comprises a battery casing (140) comprising at least one battery (140b) coupled to the motor (110) and configured to provide power to the motor (110).