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:
VALVULOPLASTY CATHETER

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, India.

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 valvuloplasty catheter with a filter.
BACKGROUND OF INVENTION
[2] In certain conditions, when calcium or any deposits (hereinafter, deposits) are accumulated in a blood vessel of a patient, the vessel is blocked and normal functioning of the vessel is hampered. The vessel is then required to undergo a treatment to break the deposits. A valvuloplasty catheter (hereinafter, catheter) is one such device which is used to break the deposits into small debris and restore the functioning of the vessel.
[3] Conventionally, a catheter includes a mechanism to break the debris. For example, in some cases, the conventional catheter uses an external impact generating shaft to vibrate the fluid inside a balloon to break the debris. The debris are then removed from the vessels using another device. Due to these features, the process of treatment becomes complex and more traumatic.
[4] Therefore, there arises a need for a catheter that overcomes the problems associated with the conventional catheters.
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 catheter. In an embodiment, the catheter includes a catheter tube, a control unit, a balloon assembly, and a filter assembly. The catheter tube has a proximal end, a distal end and a lumen. The control unit is disposed towards the proximal end of the catheter tube. The control unit includes a handle having a slot, a hemostasis hub and a slider. The slot of the handle has a proximal end and a distal end. The hemostasis hub, having a hub casing, is slidably disposed within the handle. The slider is coupled to the hub casing and is slidably disposed within the slot of the handle. The balloon assembly is coupled to the distal end of the catheter tube. The balloon assembly includes a balloon and a motor. The balloon has a proximal end and a distal end. The proximal end of the balloon is coupled to the distal end of the catheter tube and the distal end of the balloon is disposed on a distal end of a support tube. The balloon is configured to be toggled between a deflated state and a radially expanded state. The motor is mounted on the support tube within the balloon. The filter assembly is disposed proximally to the balloon assembly. The filter assembly includes a filter. The filter has a proximal end and a distal end. The filter is disposed towards the proximal end of the balloon and is configured to be slidably movable on the catheter tube. The filter includes a mesh and a plurality of support arms. The plurality of support arms extends between the proximal end and the distal end of the filter. The mesh is disposed at the proximal end of the filter and is at least partially coupled with the plurality of support arms. The filter is configured to be toggled between an expanded state and a collapsed state. In a first configuration, the slider is disposed at the proximal end of the slot and the filter is in the collapsed state. In the second configuration, the slider is disposed at the distal end of the slot and the filter is in the expanded state.

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 depicts a catheter 100 in accordance with one or more embodiments of the present disclosure.
[9] Fig. 1a depicts the catheter 100 in a first configuration, in accordance with one or more embodiments of the present disclosure.
[10] Fig. 1b depicts the catheter 100 in a second configuration, in accordance with one or more embodiments of the present disclosure.
[11] Fig. 1c depicts an exploded view of the catheter 100, in accordance with one or more embodiments of the present disclosure.
[12] Fig. 1d depicts an enlarged view of a balloon assembly 130 of the catheter 100, in accordance with one or more embodiments of the present disclosure.
[13] Fig. 2 depicts an exploded view of a motor 131 of the catheter 100, in accordance with one or more embodiments of the present disclosure.
[14] Fig. 3 depicts a connection between the motor 131 and a power source 123a, in accordance with one or more embodiments of the present disclosure.
[15] Fig. 4a depicts a cross-sectional view of a control unit 125 of the catheter 100 in the first configuration, in accordance with one or more embodiments of the present disclosure.
[16] Fig. 4b depicts a cross-sectional view of the control unit 125 of the catheter 100 in the second configuration, in accordance with one or more embodiments of the present disclosure.
[17] Fig. 5 illustrates a flowchart of a method 500 for assembling the catheter 100 before a medical procedure, according to one or more embodiments of the present disclosure.
[18] Fig. 6 illustrates a flowchart of a method 600 for operating the catheter 100 during a medical procedure, according to one or more embodiments of the present disclosure.
DETAILED DESCRIPTION OF THE DRAWINGS
[19] 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.
[20] 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.
[21] 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.
[22] 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.
[23] The present disclosure discloses a valvuloplasty catheter. This catheter is used when a patient is diagnosed with a buildup of, for example, calcium deposits, or any accumulation (hereinafter, deposits) within their blood vessels. This catheter is used to fracture or break the deposits present in the vessel(s) of the patient’s body. Post-fracturing the deposits, the catheter can capture the broken deposits (hereinafter, debris) and filter the blood thus minimizing the risk of thrombus formation, etc. The catheter thus helps in treating the diseased vessels by removing the deposits, thereby restoring the constricted vessels to their original expanded state.
[24] The catheter of the present disclosure can be used in various blood vessels like an aorta, vena cava etc. The catheter of the present disclosure can also be used to remove deposits from valves of a heart. For example, when deployed to remove deposits from the valves of the heart, the catheter is positioned such that a filter of the catheter does not completely go through the aortic arch up until the ascending aorta. Rather, the catheter is placed such that the filter expands and covers the complete inner surface of the aorta so that debris do not leak from the gap formed between the filter and the inner surface of the aorta.
[25] Now referring to the figures, Fig. 1 shows a catheter 100, according to an exemplary embodiment. Fig. 1a depicts the catheter 100 in a first configuration and Fig. 1b depicts the catheter 100 in a second configuration, according to an exemplary embodiment. Fig. 1c depicts an exploded view of the catheter 100, according to an exemplary embodiment. The first configuration and the second configuration of the catheter 100 are explained later. The catheter 100 may extend between a first end 100a and a second end 100b, thus defining a length. The length of the catheter 100 ranges from 500 mm to 2000 mm. In an exemplary embodiment, the length of the catheter 100 may be between 1380 mm and 1420 mm.
[26] The catheter 100 includes a catheter control assembly 120 (hereinafter referred as ‘control assembly 120’), a balloon assembly 130 and a filter assembly 140. The control assembly 120 is disposed at the first end 100a and the balloon assembly 130 is disposed at the second end 100b.
[27] The catheter 100 includes a catheter tube 110 disposed between the control assembly 120 and the balloon assembly 130. The catheter tube 110 may have a pre-defined shape including cylindrical, oval, rectangular, square, hexagonal etc. In an exemplary embodiment (as shown in Fig. 1), the catheter tube 110 is tubular in shape and defines a lumen. The catheter tube 110 may be made of a material such as, silicone, polyether-block-amide (PEBAX), polyurethane (PU), polyethylene (PE), polyvinylchloride (PVC), polytetrafluoroethylene (PTFE), nylon etc. In an exemplary embodiment, the catheter tube 110 is made of polyether-block-amide (PEBAX). The catheter tube 110 may have a pre-defined length ranging from 600 mm to 1800 mm. The catheter tube 110 may have a pre-defined diameter ranging from 2 mm to 4 mm. The catheter tube 110 may have a pre-defined thickness ranging from 0.2 mm to 0.5 mm. In an exemplary embodiment, the length of the catheter tube 110 may be between 1340 mm and 1360 mm. In an exemplary embodiment, diameter and thickness of the catheter tube 110 is 3 mm and 0.3 mm respectively.
[28] In an embodiment, a proximal end of the catheter tube 110 is coupled with the control assembly 120 and a distal end of the catheter tube 110 is coupled with the balloon assembly 130. The catheter tube 110 allows delivery of a fluid for example, an inflation fluid, to a balloon 135. The catheter tube 110 further acts as a passage for an electrical wire, a guidewire, etc.
[29] In an embodiment, the balloon assembly 130 is disposed at the second end 100b of the catheter 100. The balloon assembly 130 includes a motor 131, a support tube 133, a nose cone 133a and the balloon 135. In an embodiment, the balloon 135 is a non-compliant balloon.
[30] Fig. 1d depicts an enlarged view of the balloon assembly 130, according to an embodiment. The balloon 135 is disposed at the second end 100b of the catheter 100. The balloon 135 is configured to be toggled between a deflated state and a radially expanded state. While advancing into a patient’s body, the balloon 135 is inserted in the deflated state (as shown in Fig. 1a). When the balloon 135 reaches the target site, it is inflated to the radially expanded state via the inflation fluid (as shown in Fig. 1b) injected from the control assembly 120.
[31] The balloon 135 may be made of a material including without limitation nylon, polyether block amide (PEBA), polyethene terephthalate (PET), polyamide, polyurethanes, polyvinyl chloride (PVC), polyethylene (PE), etc. In an exemplary embodiment, the balloon 135 is made of nylon. The balloon 135 may have a length, outer diameter (in the deflated state) and thickness ranging from 60 mm to 70 mm, from 6 mm to 7.5 mm and from 0.03 mm to 0.10 mm, respectively. In an embodiment, the balloon 135 has a length, outer diameter (in the deflated state) and thickness of 66 mm, 6.75 mm and 0.06 mm, respectively. In the radially expanded state, the balloon 135 may have a flexible outer diameter ranging from 12 mm to 30 mm.
[32] Referring now to Fig. 1d, in an embodiment, a proximal end of the balloon 135 is coupled to the distal end of the catheter tube 110. A distal end of the balloon 135 is disposed on a distal end of the support tube 133.
[33] The support tube 133 extends between the distal end of the balloon 135 and the proximal end of the control assembly 120. The support tube 133 extends at least partially within a lumen of the catheter tube 110.
[34] The support tube 133 provides support to the balloon 135 and the motor 131 (as explained later). In an embodiment, the support tube 133 includes a lumen to allow a passage for a guidewire (not shown). The support tube 133 may be made of material including, without limitation, polytetrafluoroethylene (PTFE), polypropylene (PP), polyether block amide (PEBAX) etc. In an exemplary embodiment, the support tube 133 is made up of polytetrafluoroethylene (PTFE).
[35] The distal end of the support tube 133 is coupled to the nose cone 133a. The nose cone 133a may be made of a soft material, such as, without limitation, polyether block amide (PEBAX), silicone, nylon, polyethene terephthalate (PET), polyamide, polyurethanes, polyvinyl chloride (PVC), polyethylene (PE), etc. and is provided to avoid any traumatic experience, during the advancement of the catheter 100 into the patient’s body. In an exemplary embodiment, the nose cone 133a is made of polyether block amide (PEBAX). A distal end of the nose cone 133a includes an axial passage that facilitates the passage for the guidewire.
[36] The motor 131 is mounted on the support tube 133 within the balloon 135. In an embodiment, the motor 131 is a low voltage DC vibration motor. The motor 131 includes a shaft 131b. The motor 131 induces vibrations through the rotational motion of the shaft 131b of the motor 131 (as shown in Fig. 2). Referring now to Fig. 2, the motor 131 has a positive terminal 131e and a negative terminal 131d connected to a power source 123a (as shown in Fig. 3). In an embodiment, the motor 131 includes a resistance coating 131c on its outer surface to protect the motor 131 from a fluid, say, the inflation fluid. In an exemplary embodiment, the resistance coating 131c is made of a material including without limitation aluminum, stainless steel etc. In an embodiment, the resistance coating 131c is made of stainless steel. Other functionally equivalent resistance coating 131c are also within the scope of the teachings of the present disclosure.
[37] In an embodiment, as shown in Fig. 2, the shaft 131b of the motor 131 is coupled to an eccentric mass 131a at a distal end of the shaft 131b. The eccentric mass 131a is coupled to the shaft 131b such that the eccentric mass 131a is off-center to the axis of rotation of the shaft 131b. Though in the depicted embodiment, a single eccentric mass 131a is used, it is possible that more than one eccentric masses 131a are used. The eccentric mass 131a may be made of a metal. In an exemplary embodiment, the eccentric mass 131a is made of stainless steel.
[38] During operation, due to the coupling of the eccentric mass 131a with the shaft 131b, an uneven centripetal force is produced which causes the motor 131 to generate lateral vibrations. The vibrations are radially transmitted via the fluid to the periphery of the balloon 135 at the target site. As a result, when an outer surface of the balloon 135, in the radially expanded state, comes in close contact with the tissues of the target site, the vibrations provide impacting force to the deposits on the tissue. Due to the impacting force, the deposits are easily broken.
[39] Referring back to Fig. 1a, in an embodiment, the filter assembly 140 is disposed proximal to the balloon assembly 130. The filter assembly 140 includes a filter 141, a sheath 143, a first marker 145a and a second marker 145b (collectively referred to as markers 145) and a stopper 147.
[40] The filter 141 captures the debris from the blood and prevents them from entering various organs of the body. In an embodiment, the filter 141 has a proximal end 141a and a distal end 141b. The distal end 141b of the filter 141 is disposed towards the proximal end of the balloon 135. The distal end 141b of the filter 141 is placed at a distance ranging from 5 mm to 10 mm from the proximal end of the balloon 135. In an exemplary embodiment, the distance between the proximal end of the balloon 135 and the distal end 141b of the filter 141 is 6 mm. The distance between the proximal end of the balloon 135 and the distal end 141b of the filter 141 offers several advantages. For example, when the balloon 135 is positioned over the valve of the heart, the filter 141 is then situated between the ascending aorta and the brachiocephalic artery, in order to capture the debris. The filter 141, thereby, effectively captures debris in the ascending aorta, preventing them from migrating into other body organs.
[41] In an embodiment, the filter 141 may be in shape of an ellipse and disposed on the catheter tube 110. The length of the filter 141 on the major axis (that is, along a longitudinal axis of the catheter 100) may range from 40 mm to 80 mm and its length on the minor axis (that is, perpendicular to the longitudinal axis of the catheter 100) may range from 25 mm to 40 mm. Other shapes of the filter 141 such as, without limitation, cupola, hemispherical, conical, faceted, dome, etc., are within the scope and teachings of the present disclosure. The filter 141 includes a mesh 141c and a plurality of support arms 141d (hereinafter support arms 141d). The mesh 141c is disposed towards the proximal end 141a of the filter 141 and at least partially coupled to the support arms 141d. The support arms 141d extend from the proximal end 141a of the filter 141 to the distal end 141b of the filter 141.
[42] In an embodiment, the mesh 141c of the filter 141 is braided. Other types of the mesh 141c of the filter 141 (for example, laser cut) are within the scope and teachings of the present disclosure. The mesh 141c may extend up to a pre-defined length of the filter 141 on its major axis. In an embodiment, the mesh 141c extends up to half the length of the filter 141 on its major axis. The mesh 141c may be made of a material including, without limitation, stainless steel, nitinol, titanium, nickel, copper, etc. In an exemplary embodiment, the mesh 141c is made of nitinol.
[43] In an embodiment, the filter 141 includes three support arms 141d. The support arms 141d enable expansion or collapse of the filter 141.
[44] The support arms 141d includes threads, wires, etc. In an exemplary embodiment, the support arms 141d are made of braided wires wound to form a rope-like structure. The braided wires may be made of a material including, without limitation, stainless steel, nitinol, titanium, nickel, copper, etc. In an exemplary embodiment, the support arms 141d are made using braided wires of nitinol.
[45] The filter 141 is configured to be slidably movable on the catheter tube 110. For example, the distal end 141b of the filter 141 is configured to be slidably movable on the catheter tube 110 and the proximal end 141a of the filter 141 is fixedly coupled with the sheath 143 (as explained later). Further, the filter 141 has a collapsed state and an expanded state. The filter 141 is configured to be toggled between the expanded state and the collapsed state.
[46] In the expanded state, the mesh 141c of the filter 141 expands and captures the debris from the blood and prevents them from entering various organs of the body, thus functioning as a filtration mechanism.
[47] The catheter 100 is designed in such a way that the debris is collected in the mesh 141c of the filter 141 when the filter 141 is in the expanded state. The debris is collected in the mesh 141c of the filter 141.
[48] In an example implementation, in order to correctly position the filter 141 inside the vessel, the first and second markers 145a and 145b are provided, one on each end of the filter 141. In an embodiment, the first marker 145a is disposed at the distal end 141b of the filter 141 and the second marker 145b is disposed at the proximal end 141a of the filter 141. The first marker 145a couples the support arms 141d to the catheter tube 110 at the distal end 141b of the filter 141. The second marker 145b couples the support arms 141d along with the mesh 141c of the filter 141 to the sheath 143 at the proximal end 141a of the filter 141. The markers 145 provides strength to hold the support arms 141d and the mesh 141c of the filter 141.
[49] The markers 145 may be shaped as a band. The markers 145 are made of a radiopaque material including, without limitation, platinum-iridium, tantalum, polyurethane, etc. In an exemplary embodiment, the markers 145 are made of platinum-iridium.
[50] In an embodiment, the stopper 147 is disposed on the catheter tube 110 distal to the first marker 145a. The stopper 147 restricts movement of the first marker 145a in a distal direction during the expansion of the filter 141.
[51] In an embodiment, the sheath 143 extends between the proximal end 141a of the filter 141 and the control assembly 120. The sheath 143 is disposed axially over the catheter tube 110, i.e., the catheter tube 110 at least partially extends within a lumen of the sheath 143. In an example implementation, a distal end of the sheath 143 is coupled to the proximal end 141a of the filter 141 with help of the second marker 145b and a proximal end of the sheath 143 is coupled to a distal end of a hemostasis hub 125f (explained later). The sheath 143 helps to toggle the filter 141 between its expanded and collapsed state. The sheath 143 is configured to axially slide over the catheter tube 110 with the help of the control assembly 120 as explained later.
[52] In an exemplary embodiment, the sheath 143 has a tubular shape. The length of the sheath 143 ranges from 400 mm to 1600 mm. In an exemplary embodiment, the length of the sheath 143 is 1220 mm. The sheath 143 may be made of a material including, without limitation, silicone, polyether-block-amide (PEBAX), polyurethane (PU), polyethylene (PE), polyvinylchloride (PVC), polytetrafluoroethylene (PTFE), nylon, etc. In an exemplary embodiment, the sheath 143 is made of polyether-block-amide (PEBAX).
[53] The control assembly 120 includes a hub 121, a power unit 123 and a control unit 125.
[54] In an embodiment, the hub 121 includes an infusion port 121a, a guidewire port 121b and a cable port 121c. In an exemplary embodiment, the infusion port 121a, the guidewire port 121b and the cable port 121c further meet distally and are coupled to the catheter tube 110.
[55] The infusion port 121a is configured to receive the inflation fluid (e.g., a saline liquid) to be infused into the balloon 135 through the catheter tube 110. A syringe or any mechanical injecting device (not shown) filled with the inflation fluid is coupled to the infusion port 121a to inject the inflation fluid into the catheter tube 110. The infusion port 121a may, optionally, include a rubber slitted valve to avoid the leakage of the inflation fluid.
[56] In an embodiment, the guidewire port 121b is configured to receive the guidewire. The guidewire port 121b may, optionally, include a rubber slitted valve to avoid leakage of blood.
[57] In an exemplary embodiment, the cable port 121c is configured to allow passage of a plurality of cables 123c (hereinafter cables 123c) to deliver power to the motor 131. The cable port 121c may, optionally, include a gasket seal to avoid the leakage of any fluid.
[58] Fig. 3 shows the power unit 123, according to an embodiment. The power unit 123 includes the power source 123a, switch 123b and the cables 123c.
[59] The power source 123a provides DC power to the motor 131. In an embodiment, the power source 123a is connected to AC supply mains via a power cord 123a1 and includes a rectifier to convert AC voltage to DC voltage to power the motor 131. In another embodiment, the power source 123a may include one or more DC batteries providing DC voltage to power the motor 131. In an embodiment, the power source 123a includes a voltage regulator to regulate the voltage provided to the motor 131 as per requirements.
[60] The power source 123a is electrically coupled to the motor 131 through the cables 123c. The cables 123c are passed through the catheter tube 110 and connects to the motor 131. In an embodiment, the cables 123c include two cables connecting the power source 123a with the positive terminal 131e and the negative terminal 131d, via the switch 123b.
[61] In an embodiment, the switch 123b controls the power to the motor 131. The switch 123b is configured to be toggled between a pushed state and a normal state. The motor 131 is turned ON and OFF by operating the switch 123b. In an embodiment, the switch 123b is a push button switch. When the switch 123b is in the pushed state, the motor 131 turns and stays ON. When the switch 123b is in the normal state, the motor 131 turns and stays OFF.
[62] Fig. 1c, Fig. 4a and Fig. 4b shows the control unit 125, according to an embodiment. The control unit 125 is disposed towards the proximal end of the catheter tube 110, The control unit 125 includes a handle 125a, a slider 125b and the hemostasis hub 125f. The hemostasis hub 125f is slidably disposed within the handle 125a. The hemostasis hub 125f includes a hemostasis valve (not shown), a hub casing 125f1, a hemostasis tube 125f2 and a three-way stop cock 125f3.
[63] The handle 125a may be of ergonomic shape for easy handling. The handle 125a may have a pre-defined shape including rectangular, cylindrical, flat plate, C type, U type etc. In an exemplary embodiment (as shown in Fig. 1c), the handle 125a is rectangular in shape having a trapezoidal head at a distal end of the handle 125a. In an embodiment, the handle 125a includes a slot 125c, a first lock 125d and a second lock 125e.
[64] The handle 125a may be made of a material including, without limitation, polycarbonate (PC), acrylonitrile butadiene styrene (ABS), polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC) etc. In an exemplary embodiment, the handle 125a is made of polycarbonate (PC).
[65] The handle 125a may include a first casing 125a1 and a second casing 125a2, which when coupled together form the handle 125a. The first casing 125a1 and the second casing 125a2 may be coupled together using any known techniques in the art.
[66] The first casing 125a1 has a slot 125c1 on its top surface. The first casing 125a1 includes a plurality of male studs (not shown). In an embodiment, the first casing 125a1 includes four male studs. It should be appreciated that the number of the plurality of male studs disclosed herein are exemplary and any other number of the plurality male studs can be used without deviating from the scope of the disclosure.
[67] The second casing 125a2 has a slot 125c2 on the top surface. The second casing 125a2 includes a plurality of grooves 125h. In an embodiment, the second casing 125a2 includes four grooves 125h. It should be appreciated that the number of the plurality of grooves 125h disclosed herein are exemplary and any other number of the plurality of grooves 125h can be used without deviating from the scope of the disclosure.
[68] In an embodiment, each groove 125h of the plurality of grooves 125h mates with a corresponding male stud of the plurality of male studs to couple the first casing 125a1 with the second casing 125a2. When the first and second casings 125a1, 125a2 are coupled, they form a cavity to hold the components of the control unit 125. When the plurality of grooves 125h mate with the plurality of male studs, the slot 125c1 on the top surface of the first casing 125a1 and the slot 125c2 on the top surface of the second casing 125a2 forms the slot 125c. The slot 125c has a proximal end and a distal end.
[69] The first lock 125d is disposed on the distal end of the slot 125c and the second lock 125e is disposed on the proximal end of the slot 125c. In an embodiment, the first lock 125d includes two protrusions with each protrusion extruded from the first casing 125a1 and the second casing 125a2, respectively, such that they face each other. Similarly, the second lock 125e includes two protrusions with each protrusion extruded from the first casing 125a1 and the second casing 125a2, respectively, such that they face each other (shown in Fig. 4a and Fig. 4b).
[70] The slider 125b controls the expansion and collapse of the filter 141. The slider 125b is coupled to the hub casing 125f1 of the hemostasis hub 125f. In an embodiment, the slider 125b forms an integral structure with the hub casing 125f1. The hub casing 125f1 has a hollow, tubular structure. The slider 125b is disposed within the slot 125c. The slider 125b is placed in the slot 125c such that the slider 125b is able to slide smoothly in the slot 125c from the proximal end of the slot 125c to the distal end of the slot 125c and vice versa.
[71] In an embodiment, one end of the hemostasis tube 125f2 is coupled with the hemostasis hub 125f laterally. The three-way stop cock 125f3 is coupled to the hemostasis hub 125f via the other end of the hemostasis tube 125f2.
[72] In the first configuration of the catheter 100, the slider 125b is at the proximal end of the slot 125c engaging the second lock 125e. Due to the coupling of the slider 125b with the hemostasis hub 125f via the hub casing 125f1, the hemostasis hub 125f is at the proximal end of the slot 125c. Consequently, the filter 141 is in the collapsed state. Further, the balloon 135 is in the deflated state. The states of the slider 125b, the filter 141 and the balloon 135 when the catheter 100 is in the first configuration are illustrated in Fig. 1a and Fig. 4a.
[73] In the second configuration of the catheter 100, the slider 125b is pushed from the proximal end of the slot 125c to the distal end of the slot 125c to engage with the first lock 125d. Due to the coupling of the slider 125b with the hemostasis hub 125f via the hub casing 125f1, the hemostasis hub 125f moves in a distal direction to the distal end of the slot 125c. As a result, the sheath 143 is pushed towards a distal direction, causing the filter 141 to be in the expanded state. Further, the balloon 135 is inflated to the inflated state using the inflation fluid. The states of the slider 125b, the filter 141 and the balloon 135 when the catheter 100 is in the second configuration are illustrated in Fig. 1b and Fig. 4b.
[74] Fig. 5 illustrates a flowchart of a method 500 for assembling the catheter 100, according to an embodiment.
[75] At step 501, the balloon assembly 130 is assembled. According to an embodiment, the support tube 133 is disposed within the catheter tube 110. The motor 131 with the eccentric mass 131a is disposed on the support tube 133. The proximal end of the balloon 135 is coupled to the distal end of the catheter tube 110 using, for example, heat bonding and the distal end of the balloon 135 is coupled with the nose cone 133a using, for example, heat bonding.
[76] At step 503, the stopper 147 is coupled with the catheter tube 110. The stopper 147 is disposed on the outer surface of the catheter tube 110 proximally to the balloon assembly 130. The stopper 147 is disposed at a distance ranging from 5 mm to 10 mm from the balloon assembly 130, according to an embodiment.
[77] At step 505, the filter assembly 140 is assembled. In an embodiment, the proximal end of the filter 141 is coupled to the distal end of the sheath 143 using, for example, the second marker 145b. The distal end of the filter 141 is coupled to the first marker 145a. The proximal end of the sheath 143 is coupled to the hemostasis hub 125f using, for example, UV bonding.
[78] At step 507, the balloon assembly 130 and the filter assembly 140 are assembled with each other. In an embodiment, the proximal end of the catheter tube 110 is inserted through the first marker 145a into a lumen of the sheath 143 from a distal end of the sheath 143. The catheter tube 110 is further pushed until the proximal end of the catheter tube 110 emerges out from a proximal end of the hemostasis hub 125f.
[79] At step 509, the hub 121 is coupled with the proximal end of the catheter tube 110. In an embodiment, a distal end of the hub 121 is bonded to the proximal end of the catheter tube 110.
[80] At step 511, the power unit 123 is coupled to the motor 131. In an embodiment, the cables 123c are inserted into the catheter tube 110 via the cable port 121c to emerge out at the distal end of the catheter tube 110. The cables 123c are coupled to the positive terminal 131e and the negative terminal 131d of the motor 131. The power source 123a and the switch 123b are coupled to the cables 123c.
[81] At step 513, the first casing 125a1 and the second casing 125a2 are coupled together to form the handle 125a.
[82] Referring to figures, Fig. 6 illustrates a method 600 for operating the catheter 100 during a medical procedure, according to an embodiment.
[83] At step 601, the catheter 100 is inserted into the patient’s body and traversed to a target location. During the insertion and traversal of the catheter 100 to the target location, the catheter 100 is in the first configuration (as shown in Fig. 1a). In the first configuration, the slider 125b is at the proximal end of the slot 125c. The balloon 135 is in the deflated state and the filter 141 is in the collapsed state.
[84] Once the catheter 100 is positioned at the required target location, at step 603, the slider 125b is moved from the proximal end of the slot 125c to the distal end of the slot 125c to engage with the first lock 125d. Due to the coupling of the slider 125b with the hemostasis hub 125f via the hub casing 125f1, the hemostasis hub 125f moves to the distal end of the slot 125c. In response to the slider 125b being moved to the distal end of the slot 125c, the sheath 143 moves in a distal direction, thereby causing the filter 141 to be in the expanded state and the slider 125b engages with the first lock 125d.
[85] At step 605, the inflation fluid is injected from the infusion port 121a into the balloon 135 to inflate the balloon 135 to the radially expanded state. The catheter 100 is, thus, in the second configuration.
[86] At step 607, the switch 123b is toggled to pushed state to turn ON the motor 131. As a result, the shaft 131b of motor 131 rotates. Due to the rotation of the shaft 131b, vibrations are produced due to the coupling of the eccentric mass 131a on the shaft 131b. The vibrations are transmitted radially via the inflation fluid to the outer periphery of the balloon 135. The outer periphery produces vibrational tremors due to which an impacting force is exerted on the deposits which breaks the deposits inside the vessels as well as the deposits present on the outer surface of the stenosis valve, thus creating debris. The debris are captured into the filter 141.
[87] At step 609, the switch 123b is toggled to normal state to turn OFF the motor 131.
[88] At step 611, the slider 125b is moved from the distal end of the slot 125c to the proximal end of the slot 125c. Due to the coupling of the slider 125b with the hemostasis hub 125f via the hub casing 125f1, the hemostasis hub 125f moves to the proximal end of the slot 125c. In response to the slider 125b being moved to the proximal end of the slot 125c, the sheath 143 moves in a proximal direction, thereby causing the filter 141 to be in the collapsed state and the slider 125b engages with the second lock 125e. The filter 141 holds the debris in the mesh 141c.
[89] At step 613, the balloon 135 is deflated by draining the inflation fluid via the infusion port 121a. As a result, the catheter 100 is toggled to be in the first configuration.
[90] At step 615, the catheter 100 is removed from the patient’s body.
[91] 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 catheter (100) comprising:
a. a catheter tube (110) having a proximal end, a distal end and a lumen;
b. a control unit (125) disposed towards the proximal end of the catheter tube (110), the control unit (125) including:
i. a handle (125a) having a slot (125c), the slot (125c) having a proximal end and a distal end,
ii. a hemostasis hub (125f) having a hub casing (125f1), the hemostasis hub (125f) slidably disposed within the handle (125a), and
iii. a slider (125b) coupled to the hub casing (125f1) and slidably disposed within the slot (125c) of the handle (125a);
c. a balloon assembly (130) coupled to the distal end of the catheter tube (110), the balloon assembly (130) including:
i. a balloon (135) having a proximal end coupled to the distal end of the catheter tube (110), a distal end disposed on a distal end of a support tube (133), the balloon (135) configured to be toggled between a deflated state and a radially expanded state; and
ii. a motor (131) mounted within the balloon (135) on the support tube (133); and
d. a filter assembly (140) disposed proximal to the balloon assembly (130), the filter assembly (140) comprising:
i. a filter (141) having a proximal end (141a) and a distal end (141b) disposed towards the proximal end of the balloon (135), the filter (141) configured to be slidably movable on the catheter tube (110), the filter (141) including a mesh (141c) and a plurality of support arms (141d), the plurality of support arms (141d) extends from the proximal end (141a) to the distal end (141b) of the filter (141), the mesh (141c) is disposed at the proximal end (141a) of the filter (141) and at least partially coupled to the plurality of support arms (141d), the filter (141) configured to be toggled between an expanded state and a collapsed state;
wherein, in a first configuration, the slider (125b) is disposed at the proximal end of the slot (125c) and the filter (141) is in the collapsed state;
wherein, in a second configuration, the slider (125b) is disposed at the distal end of the slot (125c) and the filter (141) is in the expanded state.
2. The catheter (100) as claimed in claim 1, wherein the motor (131) includes a shaft (131b) and an eccentric mass (131a) coupled to a distal end of the shaft (131b).
3. The catheter (100) as claimed in claim 2, wherein the eccentric mass (131a) is off-center to an axis of rotation of the shaft (131b).
4. The catheter (100) as claimed in claim 1, wherein the distal end (141b) of the filter (141) disposed at a distance from the proximal end of the balloon (135), the distance ranging from 5 mm to 10 mm.
5. The catheter (100) as claimed in claim 1, wherein the mesh (141c) extends up to a pre-defined length of the filter (141) on its major axis.
6. The catheter (100) as claimed in claim 1, wherein the distal end (141b) of the filter (141) is configured to be slidably movable on the catheter tube (110).
7. The catheter (100) as claimed in claim 1, wherein a first marker (145a) couples the support arms (141d) to the catheter tube (110) at the distal end (141b) of the filter (141).
8. The catheter (100) as claimed in claim 1, wherein a second marker (145b) couples the support arms (141d) and the mesh (141c) to the sheath (143) at the proximal end (141a) of the filter (141).
9. The catheter (100) as claimed in claim 8, wherein a stopper (147) is disposed on the catheter tube (110) distal to the first marker (145a).
10. The catheter (100) as claimed in claim 1, wherein a hub (121) is coupled to the proximal end of the catheter tube (110), the hub (121) including:
a. an infusion port (121a) configured to receive an inflation fluid,
b. a guidewire port (121b) configured to receive a guidewire, and
c. a cable port (121c) configured to allow passage of a plurality of cables (123c) electrically coupling the motor (131) to a power source (123a).
11. The catheter (100) as claimed in claim 1, wherein a switch (123b) controls the power to the motor (131), the switch (123b) configured to be toggled between:
a. a pushed state to turn ON the motor (131), and
b. a normal state to turn OFF the motor (131).
12. The catheter (100) as claimed in claim 1, wherein the filter assembly (140) comprises a sheath (143) having a proximal end coupled to the hemostasis hub (125f) and a distal end coupled to the proximal end (141a) of the filter (141), the catheter tube (110) at least partially extending within a lumen of the sheath (143) such that the sheath (143) is configured to axially slide over the catheter tube (110); wherein, in response to the slider (125b) being moved to the distal end of the slot (125c), the sheath (143) moves in a distal direction, thereby causing the filter (141) in the expanded state; and in response to the slider (125b) being moved to the proximal end of the slot (125c), the sheath (143) moves in a proximal direction, thereby causing the filter (141) in the collapsed state.
13. The catheter (100) as claimed in claim 1, wherein a first lock (125d), disposed at the distal end of the slot (125c), is configured to engage the slider (125b) and a second lock (125e), disposed at the proximal end of the slot (125c), is configured to engage the slider (125b).
14. The catheter (100) as claimed in claim 1, wherein the catheter (100) comprises a power source (123a) electrically coupled to the motor (131) and configured to provide power to the motor (131).
15. The catheter (100) as claimed in claim 1, wherein the slider (125b) forms an integral structure with the hub casing (125f1).
16. The catheter (100) as claimed in claim 1, wherein the support tube (133) extends at least partially within the lumen of the catheter tube (110), a distal end of the support tube (133) is coupled to a nose cone (133a).