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

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

FIELD OF INVENTION
[1] The present disclosure relates to a medical device. More particularly, the present disclosure relates to a blood pumping device.
BACKGROUND OF INVENTION
[2] A percutaneous coronary intervention (PCI) procedure is a minimally invasive procedure commonly performed, for example, to remove blockages in a coronary artery. However, in patients suffering from left ventricle dysfunction (LVD) where the left ventricle (LV) is unable to pump sufficient blood from the LV into the aorta, the PCI procedure poses a significant risk. In such situations, a blood pumping device is used to pump the blood, for example, from the LV to the aorta to reduce the risk.
[3] Conventional blood pumping devices has several drawbacks. For example, they have a bulky profile/design, causing challenges in the device delivery and placement. Further, they utilize motors rotating at high rotational speeds (e.g., 50000 RPM and beyond) for efficient blood circulation. However, due to the high rotational speeds, the motor may overheat and produce vibration, which can damage blood cells inside the heart.
[4] Additionally, some devices feature uncovered motors, which pose life risks for the patients because when a fault occurs, the body and the blood may come in contact with electrical components of motor.
[5] Thus, there arises a need for a medical device that overcomes the problems associated with the conventional devices.
SUMMARY OF INVENTION
[6] 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.
[7] The present disclosure relates to a blood pumping device for pumping blood from the left ventricle (LV) to the aorta. In an embodiment, the blood pumping device includes a motor, an impeller, an enclosure, and a tube. The motor is disposed at a distal end of the blood pumping device and has a shaft. The impeller is coupled to the motor. The impeller includes a hub coupled to the shaft and a blade coupled to the hub. The hub has a frustum shape with a diameter of the hub reducing from a distal end of the impeller to a proximal end of the impeller. The blade is configured to rotate in response to the rotation of the shaft. The enclosure includes a body configured to enclose the hub and the blade, and defines a channel extending between a distal end of the body and a proximal end of the body. The body has a frustum shape, with a diameter of the body reducing from the distal end of the body to the proximal end of the body. The enclosure includes two or more arms extending from the distal end of the body towards a distal end of the enclosure. The two or more arms defines two or more inlets configured to provide a passage for the blood in the LV into the body. The tube is coupled to the proximal end of the body and includes two or more outlets provided circumferentially on the tube. The two or more outlets are configured to provide a passage for the blood in the body into the aorta. Upon deployment, the two or more inlets are configured to reside within the LV and the two or more outlets are configured to reside within the aorta. In response to the rotation of the motor, the impeller is configured to rotate, thereby creating a centrifugal suction force to draw the blood in the LV into the enclosure via the two or more inlets, channelize the blood through the channel of the body and push the blood into the aorta via the two or more outlets.
BRIEF DESCRIPTION OF DRAWINGS
[8] 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.
[9] Fig. 1 depicts an assembled view of a blood pumping device 100, in accordance with an embodiment of the present disclosure.
[10] Fig. 1a depicts an assembled view of a pump 110, in accordance with an embodiment of the present disclosure.
[11] Fig. 1b depicts the pump 110 placed inside the left ventricle of a human heart, in accordance with an embodiment of the present disclosure.
[12] Fig. 1c depicts a motor 111, in accordance with an embodiment of the present disclosure.
[13] Fig. 1d depicts an impeller 113, in accordance with an embodiment of the present disclosure.
[14] Fig. 1e depicts an enclosure 115, in accordance with an embodiment of the present disclosure.
[15] Fig. 1f depicts a support element 117, in accordance with an embodiment of the present disclosure.
[16] Fig. 2 illustrates a flowchart of a method 300 for placing and operating the pump 110 during a medical procedure, in accordance with an embodiment of the present disclosure.
[17] Fig. 3 depicts the blood pumping device 100 in a crimped configuration, in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE DRAWINGS
[18] 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.
[19] 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.
[20] 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.
[21] 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.
[22] The present disclosure discloses a blood pumping device (or a device). In an embodiment, the device includes a pump to transfer the blood from the left ventricle (hereinafter, interchangeably referred to as LV) to the aorta. The pump includes a motor, an impeller and an enclosure. The enclosure provides a passage for the blood from the LV to the aorta. The pump includes two or more inlets at its distal end providing a passage for blood in the LV to enter the enclosure and two or more outlets at its proximal end providing a passage for the blood from the enclosure into the aorta. The pump also includes a support element configured to rest on the annulus of the LV, which helps the pump to get stabilized inside the left ventricle of the heart.
[23] The impeller and the enclosure have a tapered shape, according to an embodiment. The diameter of the impeller and the enclosure taper decreases from a distal end of the pump to a proximal end of the pump (in other words, from the annulus of the LV towards the aorta). The tapered shape allows greater volume of blood to pass, increases the velocity of the blood and reduces its pressure due to a phenomenon known as the venturi effect. Consequently, the proposed pump is able to pump the blood effectively and efficiently at lower speeds of the motor as compared to speeds of motors in the conventional devices. Therefore, the device prevents problems associated with high-speed motors observed in the conventional devices.
[24] Now referring to the figures, Fig. 1 shows an assembled view of a blood pumping device 100 (or device 100) according to an embodiment. The blood pumping device (100) is configured to pump blood from the left ventricle (LV) to the aorta. The device 100 may extend between a distal end 100a and a proximal end 100b, thus defining a length. The device 100 includes a pump 110, a catheter tube 120, a plug 130 and a controller 140.
[25] Fig. 1a depicts various components of the pump 110, according to an embodiment. The pump 110 is provided at the distal end 100a the device 100. The pump 110 has a distal end 110a and a proximal end 110b. The pump 110 is configured to pump the blood from the left ventricle (LV) to the aorta. The pump 110 is placed, such that, the distal end 110a is located inside the LV and the proximal end 110b is located in the aorta (as shown in Fig. 1b). The pump 110 includes a motor 111, an impeller 113, an enclosure 115 and a support element 117.
[26] In an embodiment, the motor 111 is an electrically powered DC motor. Referring to Fig. 1c, the motor 111 has a distal end 111a, a proximal end 111b, and includes a shaft 111c. The motor 111 is disposed at a distal end 100a of the device 100. The motor 111 is configured to drive the impeller 113. The impeller 113 is coupled to the motor 111 via the shaft 111c. The shaft 111c of the motor 111 provides rotational motion to the impeller 113, which further enables the transferring of the blood. The motor 111 is electrically coupled to a power source (not shown) provided in the plug 130.
[27] In an exemplary embodiment, the distal end 111a of the motor 111 is coupled to the support element 117 (explained later). The motor 111 may have any suitable shape. In an exemplary embodiment, the motor 111 is cylindrical in shape. The motor 111 may have a power rating ranging from 10 W to 30 W. In an exemplary embodiment, the motor 111 has a power rating of 19 W. Teachings of the present disclosure enable the motor 111 to rotate at speeds lower than motors in the conventional devices while still maintaining sufficient pumping efficiency. In an embodiment, the motor 111 rotates at speeds less than or equal to 25000 RPM.
[28] The impeller 113 is configured to rotate in response to the rotation of the motor 111 (and the shaft 111c. The rotation of the impeller 113 creates a centrifugal suction force that draws blood into the pump 110. Referring to Fig. 1d, the impeller 113 has a distal end 113a and a proximal end 113b, and includes a hub 113c, a blade 113d and a guide element 113e.
[29] The hub 113c provides support to the blade 113d. The blade 113d and the guide element 113e are coupled to the hub 113c as shown in Fig. 1d.
[30] In an embodiment, the hub 113c has a frustum shape i.e., the diameter of the hub 113c reduces gradually from distal end 113a to the proximal end 113b. In an embodiment, the diameter of the hub 113c ranges from 5 mm to 10 mm at the distal end 113a and the diameter of the hub 113c ranges from 2 mm to 6 mm at the proximal end 113b. In an exemplary embodiment, the diameter of the hub 113c is 6 mm at the distal end 113a and 3 mm at the proximal end 113b. The frustum shape increases the flow rate of the blood from the distal end 113a to the proximal end 113b and allows greater volume of blood to pass for a given rotational speed of the impeller 113 due to the venturi effect.
[31] In an embodiment, the hub 113c has a solid body. The hub 113c can be made of a material such as, without limitation, stainless steel, titanium, nitinol, etc. In an exemplary embodiment, the hub 113c is made of titanium. The hub 113c includes a hole (not shown) on a distal face (not shown) of the hub 113c. The hole is centrally located with respect to the longitudinal axis of the hub 113c. The hole extends partially within the body of the hub 113c. In an embodiment, the hub 113c is coupled to the shaft 111c via the hole. For example, the shaft 111c is inserted into the hole and coupled to the hub 113c using any suitable coupling technique such as, welding, bonding, etc. In an embodiment, the hub 113c is bonded to the shaft 111c.
[32] In an embodiment, the blade 113d is coupled to the hub 113c from the distal end 113a to the proximal end 113b. In the depicted embodiment, the hub 113c and the blade 113d are an integrated structure. It should be understood though that the hub 113c and the blade 113d may be separate components coupled together using any suitable coupling technique.
[33] The blade 113d has a pre-defined profile such as spiral, helical, double helical, etc. or any suitable curved profile. In the depicted embodiment, the blade 113d has a spiral profile. The blade 113d is configured to rotate in response to the rotation of the shaft 111c. As the hub 113c rotates, the blade 113d directs the blood from the distal end 113a to the proximal end 113b.
[34] In an embodiment, the guide element 113e is coupled to a proximal face of the hub 113c. A distal end of the guide element 113e is coupled to the proximal end of the hub 113c. The guide element 113e can be coupled to the hub 113c using any coupling technique known in the art such as, laser welding, spot welding, arc welding, brazing, screwing/threading and soldering, etc. In an exemplary embodiment, the guide element 113e is coupled to the hub 113c using screwing/threading. In an embodiment, the guide element 113e may form an integrated structure with the hub 113c.
[35] The guide element 113e is configured to rotate in response to the rotation of the hub 113c. The guide element 113e guides the blood away from the impeller 113 in a lateral direction. In an embodiment, the guide element 113e has a frustum shape with a concave surface. As the blood comes in contact with concave surface of the guide element 113e, the guide element 113e pushes the blood away from the longitudinal axis of the impeller 113 with force.
[36] Referring now to Fig. 1e, in an embodiment, the enclosure 115 is configured to provide a channel to the blood being directed by the impeller 113 and guide its flow. The enclosure 115 surrounds the impeller 113. The enclosure 115 is configured to channel the blood in a proximal direction.
[37] The enclosure 115 has a distal end 115a and a proximal end 115b, and includes a body 115c, two or more arms 115d (hereinafter, arms 115d), and two or more inlets 115e (as shown in Fig. 1e).
[38] In an embodiment, the body 115c is disposed towards the proximal end 115b of the enclosure 115. In an embodiment, the body 115c has a hollow structure, thereby defining the channel extending between a proximal end and a distal end of the body 115c. The body 115c is configured to enclose the hub 113c and the blade 113d. The body 115c is axially aligned with the hub 113c and the catheter tube 120. The shape of the body 115c may be similar to shape of the hub 113c. In the depicted embodiment, the body 115c has a frustum shape, with its diameter reducing gradually from the distal end to the proximal end of the body 115c. In an embodiment, the diameter of the body 115c ranges from 6 mm to 18 mm at the distal end of the body 115c and the diameter of the body 115c ranges from 3 mm to 10 mm at the proximal end of the body 115c. In an exemplary embodiment, the diameter of the body 115c is 12 mm at the distal end of the body 115c and 6 mm at the proximal end of the body 115c. The body 115c can be made of a material such as, without limitation, polyether-block-amide (PEBAX), silicon, polyurethane, etc. In an exemplary embodiment, the body 115c is made of polyurethane.
[39] In an embodiment, an outer surface of the body 115c is reinforced using a material such as, without limitation, stainless steel, nitinol, cobalt chromium, etc. In an exemplary embodiment, the outer surface of the body 115c is reinforced using nitinol. The reinforcement strengthens the body 115c.
[40] In an embodiment, the outer surface of the body 115c includes radiopaque markers (not shown). The radiopaque markers are visible with fluoroscopy and help to locate the pump 110 during its delivery and deployment at a target location inside the LV.
[41] The arms 115d are provided towards the distal end 115a of the enclosure 115. The arms 115d may be disposed uniformly or non-uniformly. In the depicted embodiment, the arms 115d are disposed uniformly. Each arm 115d of the arms 115d is coupled to the body 115c at a proximal end of the arm 115d. The arms 115d are coupled to the body 115c using any suitable coupling technique such as, UV bonding, heat bonding, adhesive, etc. In an embodiment, the arms 115d are coupled to the body 115c using UV bonding. In an exemplary embodiment, the arms 115d include four arms. A distal end of each of the arms 115d is coupled to the support element 117 to provide support to the enclosure 115 (explained later). The arms 115d can be made of a material such as, without limitation, stainless steel, nitinol, titanium, platinum, etc. In an embodiment, the arms 115d are made of stainless steel.
[42] The arms 115d define the two or more inlets 115e (hereinafter, the inlets 115e). For example, a gap between two adjacent arms 115d defines one inlet 115e of the inlets 115e. In an exemplary embodiment, the inlets 115e includes four inlets 115e arranged circumferentially. Upon deployment of the pump 110 at the target location, the inlets 115e are configured to reside within the LV. The inlets 115e are configured to provide a passage for the blood in the LV to enter into the enclosure 115.
[43] In an embodiment, the pump 110 includes a tube 119 (shown in fig. 1a). The tube 119 can be of a shape, such as, without limitation, cylindrical, frustum, oval, etc. In an exemplary embodiment, the tube 119 is generally cylindrical. The tube 119 can be made of a material such as, without limitation, stainless steel, nitinol, titanium, platinum, etc. In an embodiment, the tube 119 is made of stainless steel.
[44] A distal end of the tube 119 is coupled to the proximal end of the body 115c. The tube 119 is coupled to the body 115c of the enclosure 115 using any suitable coupling technique such as, UV bonding, heat bonding, adhesive, etc. In an embodiment, the tube 119 is coupled to the body 115c of the enclosure 115 using UV bonding. A proximal end of the tube 119 is coupled to a distal end of the catheter tube 120 using any suitable coupling technique such as, UV bonding, heat bonding, adhesive, etc. In an embodiment, the tube 119 is coupled to the catheter tube 120 using UV bonding. The tube 119 includes two or more outlets 119a (hereinafter, the outlets 119a) provided circumferentially on the tube 119. The outlets 119a are defined by respective holes provided on an outer surface of the tube 119. The outlets 119a may have any suitable shape such as, circular, oval, square, rectangular, polygonal, etc. In an exemplary embodiment, the outlets 119a includes four outlets 119a of circular shape. The outlets 119a can be arranged either uniformly or non-uniformly. In the depicted embodiment, the outlets 119a are arranged uniformly. Upon deployment of the pump 110 at the target location, the outlets 119a are configured to reside within the aorta. The outlets 119a are configured to provide a passage for the blood in the body 115c of the enclosure 115 to enter the aorta.
[45] In an embodiment, the support element 117 is provided at the distal end 110a of the pump 110. The support element 117 provides support to the motor 111 and the enclosure 115. The support element 117 also provides stability to the pump 110 inside the LV. In an embodiment, the support element 117 has a dome shaped structure. The diameter of the support element 117 at a proximal end of the support element 117 may range from 10 mm to 20 mm. In an exemplary embodiment, the diameter the support element 117 at the proximal end of the support element 117 is 15 mm. The support element 117 includes a support block 117a disposed on an inner surface of the support element 117. The support block 117a is generally cylindrical and is coupled to the support element 117 using any coupling technique known in the art such as, UV bonding, heat bonding, adhesive, etc. In an exemplary embodiment, the support block 117a is UV bonded to the inner surface of the support element 117. The support block 117a includes a slot 117b (as shown in fig. 1f). In an exemplary embodiment, the slot 117b has a cylindrical shape, though it may have any other suitable shape. The support element 117 can be made of a material such as, without limitation, silicone, polyurethane, etc. or any other suitable flexible biocompatible material so that the support element 117 can be crimped during the delivery of the pump 110 at the target location. In an exemplary implementation, the support element 117 is made of silicone. The support block 117a can be made of a material such as, without limitation, stainless steel, nitinol, titanium, platinum, etc. or any suitable biocompatible material. In an embodiment, the support block 117a is made of stainless steel.
[46] In an embodiment, the distal end 111a of the motor 111 is coupled to the slot 117b of the support element 117 using any suitable coupling technique such as, welding, bonding, soldering, brazing, etc. In an exemplary embodiment, the distal end 111a of the motor 111 is inserted into the slot 117b and welded to the slot 117b of the support element 117.
[47] In an embodiment, the distal end of the arms 115d is coupled to an inner surface of the slot 117b of the support element 117 using any suitable coupling technique such as, welding, bonding, soldering, brazing, etc. In an exemplary embodiment, the distal end of the arms 115d is welded to the inner surface of the slot 117b of the support element 117.
[48] In an embodiment, the catheter tube 120 has a hollow, tubular structure and is made of a flexible material. The catheter tube 120 may be made of a material such as, without limitation, polytetrafluoroethylene (PTFE), polyether-block-amide (PEBAX), nylon, polyurethane, etc. In an exemplary embodiment, the catheter tube 120 is made of polyurethane. The catheter tube 120 has a length ranging from 1000 mm to 1300 mm. In an exemplary embodiment, the catheter tube 120 has a length of 1250 mm.
[49] The catheter tube 120 has a distal end and a proximal end. The distal end of the catheter tube 120 is coupled to the proximal end of the tube 119 and the proximal end of the catheter tube 120 is coupled to the plug 130. The catheter tube 120 includes a lumen configured to provide a passage to a purging solution (e.g., heparin) to repair the damaged blood cells (explained later). The catheter tube 120 may also include a guidewire lumen configured to provide a passage to a guidewire (not shown). The guidewire helps in navigating the catheter tube 120 and the pump 110 to the target site in the LV. The catheter tube 120 may also include a lumen configured to provide a passage to electrical wires. The electrical wires are provided to electrically couple the motor 111 to the power source provided in the plug 130.
[50] In an embodiment, the plug 130 is provided at the proximal end 100b of the device 100. The plug 130 has a proximal end and a distal end. The distal end of the plug 130 is coupled to the proximal end of the catheter tube 120. The plug 130 is communicatively coupled to the controller 140 with the help of cables. The plug 130 is configured to receive from the controller 140, operating parameters of the device 100 and/or operating instructions to operate the device 100. The plug 130 stores the operating parameters and/or the operating instructions in a memory (not shown) so that if the controller 140 is to be replaced during a medical procedure (e.g., due to the failure of the controller 140 or any other underlying condition), the plug 130 can send the operating parameters and/or the operating instructions to another controller and the operation of the device 100 can continue seamlessly. In an exemplary embodiment. The plug 130 includes one or more lumens (not shown). For example, a first lumen (not shown) in the plug 130 provides a passage to deliver the purging solution. The plug 130 includes a reservoir of the purging solution. The plug 130 delivers the purging solution into the blood via the first lumen and the lumen of the catheter tube 120. A second lumen (not shown) of the one or more lumens is configured to provide a passage for electrical wires coupled to the motor 111 and one or more sensors coupled to the pump 110. The one or more sensors may be coupled to the support element 117 and may include a pressure sensor to sense the pressure of the blood, a temperature sensor to sense the temperature of the motor 111, etc. The plug 130 is configured to receive signals from the one or more sensors and provides them to the controller 140.
[51] The controller 140 is electrically coupled to the plug 130 and exchanges data and/or instructions between the controller 140 and the plug 130. The controller 140 is configured to control the overall operation of the device 100, for example, controlling the rotational speed of the motor 111, administering the purging solution, etc., based upon the operational status of the pump 110 (e.g., pressure of the pumped blood, temperature of the motor 111, etc.) and/or based upon a user input. The controller 140 may send appropriate control signals to the motor 111 and/or to the plug 130 accordingly. The controller 140 includes an input element (not shown) to enable the user to provide an input to control the operation of the device 100. The input element may be one or more keys, a touch pad, a touch screen, etc. or combinations thereof. The controller 140 may also include a display to display one or more parameters, e.g., a waveform showing the pressure of the pumped blood, the temperature of the motor 111, etc. The controller 140 may also provide an alarm (e.g., visual, audible, tactile, or any combinations thereof) when the motor 111 is not functioning as desired. The controller 140 is also configured to sense positioning of the pump 110 via suitable sensors coupled to the pump 110 and provide an indication of a correct placement of the pump 110. The controller 140 may include a computing unit (e.g., a microcontroller, a microprocessor, etc.) configured to receive the sensed values from various sensors and provide appropriate control signals. It should be understood that the aforesaid description of the plug 130 and controller 140 is provided by way of an example only and any other suitable plug and/or controller can be used without deviating from the scope of the present disclosure.
[52] An embodiment of delivering and operating of the pump 110 during a medical procedure is now explained. Fig. 2 illustrates a flowchart of a method 200 for delivering and operating the pump 110 during a medical procedure (e.g., a PCT procedure), according to an embodiment.
[53] At step 201, the user identifies a suitable anatomical entry point and inserts an introducer sheath 150 (depicted in Fig. 3) into the patient’s body. The user gently advances the introducer sheath 150 until it reaches a target location within the heart.
[54] At step 203, the assembly of the pump 110 and the catheter tube 120 is introduced into the vasculature via the introducer sheath 150 and navigated to the target location with the help of the guidewire. The location of the pump 110 and the catheter tube 120 can be tracked during the navigation using the radiopaque markers on the enclosure 115. As shown in Fig. 3, the introducer sheath 150 encloses the pump 110 and the catheter tube 120. The support element 117 is radially compressed as shown due to the introducer sheath 150. Thus, the radial profile of the pump 110 is crimped, which makes it easier to navigate to the target location. The introducer sheath 150 provides stability and support to the pump 110 during the delivery of the pump 110. A hemostasis hub 160 is coupled to a proximal end of the introducer sheath 150 and minimizes blood loss during the medical procedure. It should be noted that the introducer sheath 150 and the hemostasis hub 160 are omitted from Fig. 1 for reasons of clarity.
[55] At step 205, the pump 110 is placed inside the heart, such that, the distal end 110a of the pump 110 lies in the LV and the proximal end 110b of the pump 110 along with the tube 119 lies in the aorta. A distal face of the support element 117 is configured to rest on the annulus of LV (as depicted in Fig. 1b), thereby extending support and stability to the pump 110. The introducer sheath 150 is then moved backward to expose the pump 110 and a distal portion of the catheter tube 120. The support element 117 radially expands from the crimped state.
[56] At step 207, once the proper placement of the pump 110 is ensured (for e.g., using the radiopaque markers), the pump 110 is activated using the controller 140, for example, by switching the motor 111 ON. The motor 111 and the shaft 111c start rotating at a pre-defined rotational speed (e.g., at 25000 RPM). Consequently, the impeller 113 rotates and creates the centrifugal suction force. This centrifugal suction force draws blood from the LV via the inlets 115e and moves the blood in the proximal direction. The body 115c of the enclosure 115 channels the blood from its proximal end to the distal end. Once the blood reaches the proximal end 110b of the pump 110, the guide element 113e pushes the blood away from the longitudinal axis of the pump 110 into the aorta via the outlets 119a. Thus, the pump 110 starts pumping the blood from the LV to the aorta. While operating the pump 110, the rotational speed of the motor 111 can be increased or decreased, as required, using the controller 140. The controller 140 may also instruct the plug 130 to administer the purging solution based on the pressure values. Once the procedure is completed, the pump 110 can be deactivated using the controller 140, for example, by switching the motor 111 OFF. The pump 110 and the catheter tube 120 can then be taken out from the vasculature of the patient.
[57] The proposed device presents several advantages. For example, the tapered shape of the impeller and the enclosure increases the velocity and decreases the pressure of the pumped blood. As a result, the pump pumps a higher volume of blood and maximizes the flow rate of the blood even at lower rotational speeds of the motor. Therefore, the device allows the motor to run at much lower speeds as compared to conventional devices. This improves the performance of the proposed device and mitigates problems associated with higher speeds of motors, e.g., damage to blood cells due to overheating and high speed, seen in the conventional devices. Further, the device is simple and user-friendly, which enhances the overall usability of the device. The low-profile design provides comfort and ease in delivery of the device to the target location. Further, the support element mounted at the distal end of the device provides stability to the pump within the left ventricle. These features enhance overall stability and improve efficiency and effectiveness of the device over the conventional devices.
[58] 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 blood pumping device (100) for pumping blood from the left ventricle (LV) to the aorta, the blood pumping device (100) comprising:
a. a motor (111) disposed at a distal end (100a) of the blood pumping device (100) and having a shaft (111c);
b. an impeller (113) coupled to the motor (111), the impeller (113) comprising:
i. a hub (113c) coupled to the shaft (111c) and having a frustum shape with a diameter of the hub (113c) reducing from a distal end (113a) of the impeller (113) to a proximal end (113b) of the impeller (113); and
ii. a blade (113d) coupled to the hub (113c) and configured to rotate in response to the rotation of the shaft (111c);
c. an enclosure (115) comprising:
i. a body (115c) configured to enclose the hub (113c) and the blade (113d) and defining a channel extending between a distal end of the body (115c) and a proximal end of the body (115c); the body (115c) having a frustum shape, with a diameter of the body (115c) reducing from the distal end of the body (115c) to the proximal end of the body (115c); and
ii. two or more arms (115d) extending from the distal end of the body (115c) towards a distal end (115a) of the enclosure (115), the two or more arms (115d) defining two or more inlets (115e) configured to provide a passage for the blood in the LV into the body (115c); and
d. a tube (119) coupled to the proximal end of the body (115c) and comprising two or more outlets (119a) provided circumferentially on the tube (119) and configured to provide a passage for the blood in the body (115c) into the aorta;
e. wherein, upon deployment, the two or more inlets (115e) are configured to reside within the LV and the two or more outlets (119a) are configured to reside within the aorta;
f. wherein, in response to the rotation of the motor (111), the impeller (113) is configured to rotate, thereby creating a centrifugal suction force to draw the blood in the LV into the enclosure (115) via the two or more inlets (115e), channelize the blood through the channel of the body (115c) and push the blood into the aorta via the two or more outlets (119a).
2. The blood pumping device (100) as claimed in claim 1, wherein the blood pumping device (100) comprises a support element (117) provided at the distal end (100a) of the blood pumping device (100) and coupled to the motor (111) and the two or more arms (115d), the support element (117) comprising a distal face configured to rest on an annulus of the LV.
3. The blood pumping device (100) as claimed in claim 2, wherein the support element (117) is dome-shaped.
4. The blood pumping device (100) as claimed in claim 2, wherein the support element (117) comprises a support block (117a) disposed an inner surface of the support element (117), the support block (117a) comprising a slot (117b) coupled to a distal end (111a) of the motor (111) and a distal end of each arm (115d) of the two or more arms (115d).
5. The blood pumping device (100) as claimed in claim 1, wherein the impeller (113) comprises a guide element (113e) coupled to a proximal face of the hub (113c) and configured to guide the blood away from the impeller (113) in a lateral direction.
6. The blood pumping device (100) as claimed in claim 1, wherein a proximal end of the tube (119) is coupled to a distal end of a catheter tube (120).
7. The blood pumping device (100) as claimed in claim 1, wherein an outer surface of the body (115c) is reinforced.
8. The blood pumping device (100) as claimed in claim 1, wherein an outer surface of the body (115c) comprises one or more radiopaque markers.
9. The blood pumping device (100) as claimed in claim 1, wherein the blade (113d) has a spiral profile.