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:
DEVICE FOR BREAKING VALVULAR AND VASCULAR DEPOSITS
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 THE INVENTION
[1] The present disclosure relates to medical devices. More particularly, the present disclosure relates to a device for breaking valvular and vascular deposits.
BACKGROUND OF THE INVENTION
[2] Calcification and other deposits such as fibrin, cholesterol, lipids, amyloid, thrombus etc. in arteries and leaflets of heart valves pose significant health related complications such as heart attacks, reduced blood flow, impaired cardiac function and the like. Calcium deposits on inner linings of a blood vessel leads to narrowing and hardening of the blood vessel. Similarly, flexibility of heart valve leaflets is impeded by calcification of deposits on the leaflets. This hinders with the ability of proper opening and closing of the heart valves leading in impairment of cardiac function and can cause a heart attack posing significant life risk to a patient.
[3] Treatments for valvular and vascular deposition include medication-based treatments, surgical and interventional procedures, minimally invasive procedures, etc. Medication-based treatments requires intake of statins and cholesterol lowering medications, antiplatelet medications and blood pressure regulating medications, etc. Surgical and interventional procedures and minimally invasive procedures include angioplasty, stenting, bypass, valve repair, valve replacement, valvuloplasty, and the like.
[4] These conventional valvular and vascular deposition treatment procedures are not always optimal and may involve risks, such as, side effects linked to medication-based treatments, complications involved with surgical and interventional procedures, limited long-term effectiveness, and the need for personalized management strategies to optimize outcomes.
[5] Procedures also exist to mechanically break down (fragmenting) the vascular and/or valvular calcium or other deposits. For example, some conventional catheters systems apply jet sprays of fluid at a very-high pressure directly on the calcified deposits inside the vessels and/or the heart valves. Direct, high-pressure impact of the jet spray can damage the inner walls of the vessels and the surface of the heart valve leaflets. Further, balloon-based catheter systems are also available for breaking calcified deposits. Typically, these devices generate shock waves in the balloon. Due to these shock waves, the outer layer of the balloon impacts the calcified deposits leading to their breakage. In one such conventional system, the shock waves generated using electrodes placed inside the balloon. A generator is used to supply energy to the electrodes. However, very energy (of the order of thousands of volts) is required to generate one pulse of shock waves, which increases the power requirements for operating such system. Further, the increased power requirements also increase the cost of the system. Also, the generator used in such a catheter system often fails to pair with the catheter due to connection errors, leading to non-usability of the system.
[6] Another such conventional system uses a fluid jet spray to generate waves. In such a system, once the balloon is inflated, a fluid jet is emitted from inside the balloon that impacts inner side of an outer layer of the balloon. However, since the fluid jet passes through the fluid used to inflate the balloon, the fluid jet loses energy, thereby decreasing the impact force of the jet. Therefore, the said system is very inefficient.
[7] Therefore, there arises a need for a device to overcome these and other problems related to conventional devices for breaking valvular and vascular deposits.
SUMMARY OF THE INVENTION
[8] 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.
[9] The present disclosure relates to a device for fragmentation of valvular and vascular deposits. In an embodiment, the device includes an inflating element, a sleeve, and a shaft. The inflating element is configured to be in an inflated state in response to receiving an inflation fluid. The inflating element includes an outer layer and an inner layer defining a channel. The channel is configured to receive the inflation fluid. The inner layer of the inflating element further defines a cavity. The sleeve is disposed within the cavity. The sleeve is configured to receive a stream of an infusion fluid and emit jet sprays of the infusion fluid directed towards the inner layer of the inflating element. The inflating element is configured to generate pressure waves in response to the impaction of the jet sprays on the inner layer. A distal end of the inflating element and the sleeve are coupled to respective lumens of a shaft. The shaft includes a first lumen, a second lumen and a third lumen. The first lumen is coupled to a proximal end of the inflating element. The first lumen is configured to provide a passage for the inflating fluid into the channel of the inflating element. The third lumen of the shaft is coupled to a proximal end of the sleeve. The third lumen is configured to provide a passage for the stream of infusion fluid into the sleeve. The second lumen is configured to provide a passage for aspirating the infusion fluid from the cavity of the inflation element.
BRIEF DESCRIPTION OF THE DRAWINGS
[10] The summary above and the detailed description of descriptive embodiments, is better understood when read in conjunction with the apportioned drawings. For illustration of the present disclosure, exemplary embodiments of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those skilled in the art will understand that the drawings are not to scale.
[11] Fig. 1 depicts a schematic view of a device 100 for breaking valvular and vascular deposits, according to an embodiment of the present disclosure.
[12] Fig. 2a depicts a longitudinal cross-section of a shaft 130, according to an embodiment of the present disclosure.
[13] Fig. 2b depicts a transversal cross-section of the shaft 130, according to an embodiment of the present disclosure.
[14] Figs. 3a-3b depict cross-sectional views of an inflatable element 120 of the device 100, according to an embodiment of the present disclosure.
[15] Fig. 4 depicts an infusion and an aspiration assembly of the device 100, according to an embodiment of the present disclosure.
[16] Fig. 4a depicts a schematic view of a reservoir 170, according to an embodiment of the present disclosure.
[17] Fig. 5 depicts a flowchart of a method 500 for operating the device 100, according to an embodiment of the present disclosure.
[18] Fig. 6 depicts a schematic view of a device 200 for breaking valvular and vascular deposits, according to an embodiment of the present disclosure.
[19] Figs. 6a-6b depict cross-sectional views of an inflating element 220 of the device 200, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF DRAWINGS
[20] 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.
[21] 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.
[22] 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 may be used in combination with other systems, methods, and apparatuses.
[23] 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.
[24] Now referring to the figures, Fig. 1 depicts a schematic of a device 100 for breaking valvular and vascular deposits, according to an embodiment. The device 100 has a proximal end 100a and a distal end 100b. The device 100 is used for micro fragmentation of calcium and other deposits on the inner walls of vessels (e.g., arteries) and/or on the surface of heart valve leaflets. The device 100 includes a support element 110, an inflating element 120, a shaft 130, a hub 140, a pump 160 and a reservoir 170.
[25] The shaft 130 helps to deliver the inflating element 120 to a target site within a patient’s body. The shaft 130 has a proximal end 130a and a distal end 130b. The shaft 130 is coupled to the inflating element 120 at the distal end 130b of the shaft 130 and is coupled to the hub 140 at the proximal end 130a of the shaft 130. The shaft 130 has an elongated, tubular body. The shaft 130 includes a plurality of lumens extending between the proximal end 130a and the distal end 130b of the shaft 130. In an embodiment, the shaft 130 includes a first lumen 131, a second lumen 132, a third lumen 133 and a fourth lumen 134 as depicted in Figs. 2a – 2b. The first lumen 131, the second lumen 132, the third lumen 133 and the fourth lumen 134 may be concentric.
[26] The fourth lumen 134 is the innermost lumen of the shaft 130. The fourth lumen 134 has a tubular structure and is configured to provide a passage for a guidewire (not shown). The guidewire helps in navigating the device 100 through the patient’s vasculature. The fourth lumen 134 is coupled to the hub 140 at a proximal end of the fourth lumen 134.
[27] The third lumen 133 is used for infusing a fluid (hereinafter, infusion fluid) for generating high-pressure fluid jets within the inflating element 120. The third lumen 133 has a tubular structure and is configured to provide a passage to the said fluid. The third lumen 133 is coupled to the hub 140 at a proximal end of the third lumen 133.
[28] The second lumen 132 is used for aspirating the infusion fluid from within the inflating element 120. The second lumen 132 has a tubular structure and is configured to provide a passage for the said fluid. The second lumen 132 is coupled to the hub 140 at a proximal end of the second lumen 132. In an embodiment, the second lumen 132 includes an inlet 132a (shown in Fig. 3a) provided at a distal end of the second lumen 132. The inlet 132a is disposed within the inflating element 120. In an embodiment, the inlet 132a has a tapered shape such that the diameter of the inlet 132a decreases towards the proximal end of the second lumen 132. With the tapered shape, the inlet 132a functions as a funnel and guides the said fluid into the second lumen 132 more efficiently during the aspiration of the infusion fluid. In an example implementation, the inlet 132a has a conical shape.
[29] The first lumen 131 is the outermost lumen of the shaft 130. The first lumen 131 is used for inflating and deflating the inflating element 120. The first lumen 131 has a tubular structure and is configured to provide a passage for an inflation fluid. The first lumen 131 is coupled with the inflatable element 120 at a distal end of the first lumen 131 and is coupled with the hub 140 at a proximal end of the first lumen 131.
[30] The shaft 130 may be made of a material, such as, without limitation, polyether block amide (PEBAX), polyether ether ketone (PEEK), polyamide, nylon, etc. In an embodiment, the shaft 130 is made of polyether block amide (PEBAX). The shaft 130 may have a length between 80 mm and 1500 mm. The shaft 130 may have an outer diameter ranging between 1 mm and 8 mm. In an example implementation, the length and the outer diameter of the shaft 130 are 1380 mm and 2 mm, respectively.
[31] Figs. 3a and 3b depict an exemplary inflating element 120. The inflating element 120 is configured to be in the inflated state expand in response to the passage of the inflating fluid into the inflating element 120, i.e., in response to receiving the inflation fluid. The inflating element 120 may be made from a flexible, biocompatible material, such as, without limitation, latex, silicone, PEBAX, Polyethylene Terephthalate (PET), Nylon, Polyurethane (PU), etc. In an example implementation, the inflating element 120 is made from PEBAX. The inflating element 120 is configured to toggle between a deflated state (shown in Fig. 3a) and an inflated state (shown in Fig. 3b). The inflating element 120 has a proximal end 120a and a distal end 120b. The proximal end 120a of the inflating element 120 is coupled to the distal end of the first lumen 131 of the shaft 130 using a coupling technique, such as, without limitation, adhesive bonding, laser bonding, etc. In an example implementation, the proximal end 120a of the inflating element 120 is coupled to the distal end of the first lumen 131 using laser bonding. The inflating element 120 is coupled to the support element 110 at the distal end 120b of the inflating element 120. The inflating element 120 has a tubular structure. The inflating element 120 includes an outer layer 122 and an inner layer 123, defining a channel 121 between the outer layer 122 and the inner layer 123. Further, the inner layer 123 defines a cavity 124. Thus, the inflating element 120 forms a multi-layered structure. The channel 121 is configured to receive the inflation fluid via the first lumen 131. In other words, the first lumen 131 is configured to provide a passage for the inflation fluid into the channel 121. The length of the inflating element 120 may range between 10 mm and 65 mm. In an example implementation, the length of the inflating element 120 is 30 mm. In the inflated state, the width of the channel 121 may range between 2 mm and 7 mm. In an example implementation, the channel 121 has the width of 3 mm in the inflated state.
[32] The device 100 includes a sleeve 191 disposed within the cavity 124 of the inflating element 120. A proximal end of the sleeve 191 is coupled to the distal end of the third lumen 133. A distal end of the sleeve 191 is coupled to the support element 110. The sleeve 191 may be made from a biocompatible material, such as, without limitation, polytetrafluoroethylene (PTFE), polypropylene (PP), polyether block amide (PEBAX), etc. In an example implementation, the sleeve 191 is made of polytetrafluoroethylene (PTFE). The sleeve 191 has a tubular shape. The sleeve 191 includes a plurality of apertures 193 provided on an outer surface of the sleeve 191. The sleeve 191 is configured to receive a stream of the infusion fluid via the third lumen 133 (in other words, the third lumen 133 is configure to provide a passage for the stream the infusion fluid into the sleeve 191) and emit a jet spray 195 of the infusion fluid emitted via each of the apertures 193 as shown in Fig. 3b. The jet sprays 195 emitted from the sleeve 191 are directed towards an inner surface of the inner layer 123 of the inflating element 120. The apertures 193 may be designed in the form of nozzles so that the jet sprays 195 are emitted at high-pressure. In an embodiment, the apertures 193 are oriented such that the jet sprays 195 impact the inner layer 123 substantially perpendicular to maximize the impact of the jet sprays 195. The apertures 193 may be situated across the length and circumference of the sleeve 191 so that the length and inner circumference of the inflating element 120 are evenly covered with the jet sprays 195. The apertures 193 may be uniformly or non-uniformly distributed. In an embodiment, the apertures 193 may be arranged in multiple clusters, each cluster including two or more apertures 193 (as shown in Fig. 3b). It should be appreciated that the apertures 193 may be arranged in various other configurations in terms of positions and orientations based upon requirements without deviating from the scope of the present disclosure.
[33] The inflating element 120 is configured to generate pressure waves (denoted by H in Fig. 3b) in response to the impaction of the jet sprays 195 on the inner layer 123. Due to the impact of the jet sprays 195 on the inner layer 123, vibrations are created in the inflation fluid. These vibrations propagate to the outer layer 122, which in turn generates the pressure waves on an outer surface of the outer layer 122 of the inflating element 120. The pressure waves help in in micro fragmentation of the calcium deposits and/or other deposits at the target site. The frequency and energy of the pressure waves H may be controlled during the procedure as desired by increasing or decreasing the velocity of the infusion fluid entering the sleeve 191.
[34] Due to the multi-layered structure of the inflating element 120, the inflating fluid is present within the channel 121 and not in the cavity 124. Consequently, the jet sprays 195 impact the inner layer 123 of the inflating element 120 with minimal loss in energy unlike conventional balloon-based catheter systems. Therefore, the device 100 requires lower energy and the overall efficiency of the device 100 is better compared to conventional systems. The infusion fluid within the cavity 124 is aspirated as explained later. The second lumen 132 of the shaft 130 is configured to provide a passage for aspirating the infusion fluid from the cavity 124 of the inflating element 120.
[35] The sleeve 191 includes a guidewire lumen 192 provided centrally within the sleeve 191. A proximal end of the guidewire lumen 192 is coupled to the distal end of the fourth lumen 134. The guidewire lumen 192 is configured to provide a passage to the guidewire. A distal end of the guidewire lumen 192 is coupled to the support element 110.
[36] The support element 110 is provided at the distal end 100b of the device 100. The support element 110 has a tubular structure. In an embodiment, the support element 110 has a taper towards the distal end 100b such that the support element 110 has a conical shape. The support element 110 includes a guidewire lumen (not shown) extending from a proximal end of the support element 110 for an entire length of the support element 110. The guidewire lumen of the support element 110 provides a passage to the guidewire. The support element 110 further includes an inflation lumen (not shown) extending from the proximal end of the support element 110 towards the distal end of the support element 110 for a partial length of the support element 110. The inflation lumen of the support element 110 is configured to receive the inflation fluid and facilitates inflation of the inflating element 120. The distal end 120b of the inflating element 120 is coupled to the proximal end of the support element 110 such that the channel 121 of the inflating element 120 is aligned with the inflation lumen of the support element 110. Further, the proximal end of the support element 110 is coupled to the distal end of the sleeve 191. The support element 110 may be made of a soft, flexible material to minimize trauma or damage to tissues or interior walls of the vessels during navigation of the shaft 130 through the patient’s vasculature.
[37] Referring now to Fig. 4, the hub 140 is provided towards the proximal end 100a of the device 100. The hub 140 has a proximal end 140a and a distal end 140b. The distal end 140b of the hub 140 is coupled to the proximal end 130a of the shaft 130 using any coupling technique known in the art. The hub 140 may be made from a material, such as, without limitation, polycarbonate, polypropylene, etc. In an example implementation, the hub 140 is made from polycarbonate. In an embodiment, the hub 140 is a multi-port hub and includes a first port 141, a second port 142 and a third port 143. The hub 140 facilitates fluidic communication between an inflation port 150, the pump 160 and the reservoir 170 and the first lumen 131, the third lumen 133 and the second lumen 132, respectively, of the shaft 130.
[38] In an embodiment, the shaft 130 may be coupled to an infusion assembly and an aspiration assembly via the hub 140. The infusion assembly is configured to infuse the infusion fluid into the sleeve 191 via the third lumen 133 of the shaft 130 and the aspiration assembly is configured to aspirate the infusion fluid from the cavity 124 of the inflating element 120 via the second lumen 132 of the shaft 130. According to an embodiment, the infusion assembly and the aspiration assembly form a single assembly including the pump 160 and the reservoir 170. The pump 160 is used for both infusing the infusion fluid and for aspirating the infusion fluid. Similarly, the reservoir 170 provides a storage for both the infusion fluid and for the aspirated infusion fluid.
[39] The pump 160 is configured to generate the stream of the infusion fluid. In an embodiment, the pump 160 is a centrifugal pump. The pump 160 may be driven by AC power supply or a DC power supply. In an embodiment, the pump 160 may be provided with a control element (e.g., a rotating knob) configured to adjust the speed of the pump 160. The pump 160 includes an inlet port 161 and an outlet port 162. The inlet port 161 of the pump 160 is coupled to the reservoir 170 using a first conduit 185. The outlet port 162 of the pump 160 is fluidically coupled to the first port 141 of the hub 140 using a second conduit 183. The first port 141 of the hub 140 is fluidically coupled with the third lumen 133 of the shaft 130. Further, the reservoir 170 is coupled to the third port 143 of the hub 140 using a third conduit 182. The third port 143 is fluidically coupled to the second lumen 132 of the shaft 130.
[40] The reservoir 170 is configured to provide a storage for the infusion fluid. The infusion fluid may be a saline solution, dextrose solution, etc. In an example implementation, the infusion fluid is a saline solution. The reservoir 170 includes a first port 176 and a second port 178. The first port 176 of the reservoir 170 is fluidically coupled to the inlet port 161 of the pump 160 via the first conduit 185. The second port 178 of the reservoir 170 is fluidically coupled to the third port 143 of the hub 140 using the third conduit 182. The reservoir 170 may include at least one inner chamber configured to hold the liquid. The reservoir 170 may include a vent 171. The vent 171 provides a passage for the air inside the inflatable element 120 that is aspirated along with the infusion fluid, to exit the reservoir 170. In an embodiment depicted in Fig. 4, the reservoir 170 includes a single chamber for holding the infusion fluid. In another embodiment, as shown in Fig. 4a, the reservoir 170 may include a first chamber 173 and a second chamber 174. A partition 172 is provided between the first chamber 173 and the second chamber 174. The first chamber 173 is configured to hold the infusion fluid and the second chamber 174 is configured to hold the aspirated infusion fluid. The first chamber 173 is coupled to the first port 176 and the second chamber 174 is coupled to the second port 178. The partition 172 may be removable and/or adjustable so that the aspirated infusion fluid from the second chamber 174 may flow into the first chamber 173 when required.
[41] When powered on, the pump 160 is configured to draw the infusion fluid from the reservoir 170 via the inlet port 161 and drive the infusion fluid through the output port 162, thereby generating the stream of the infusion fluid. The stream of infusion fluid passes from the outlet port 162 to the sleeve 191 via the second conduit 183, the first port 141 of the hub 140 and the third lumen 133 of the shaft 130. Jet sprays 195 are generated through the apertures 193 and hit the inner layer 123 of the inflating element 120. The infusion fluid, after hitting the inner layer 123 of the inflating element 120, is aspirated from the cavity 124 and flows from the cavity 124 into the reservoir 170 via the second lumen 132 of the shaft 130, the third port 143 and the third conduit 182. The pump 160 is further configured to generate a negative pressure generated into the reservoir 170 due to the pumping action of the pump 160 and create a suction force, which causes the infusion fluid to be aspirated from the cavity 124 of the inflating element 120 back into the reservoir 170 via the second lumen 132 of the shaft 130. The inlet 132a of the second lumen 132, disposed within the cavity 124, is configured to guide the infusion fluid within the cavity 124 into the second lumen 132. Thus, the same infusion fluid is continually channeled into the sleeve 191 to generate the jet sprays 195, aspirated back in the reservoir 170 and again channeled into the sleeve 191, thereby creating a closed-loop (or a circular pathway) as depicted in Fig. 4.
[42] In another embodiment, the device 100 may have separate infusion and aspiration assemblies coupled in an open loop configuration. In this case, the device 100 includes a first pump coupled to the first port 141 of the hub 140 and a first reservoir coupled to the first pump. The first pump is configured to generate the stream of the infusion fluid and the first reservoir is configured to store the infusion fluid. The device 100 further includes a second pump coupled to the third port 143 of the hub 140 and a second reservoir coupled to the second pump. The second pump is configured to generate suction force for aspirating the infusion fluid from the cavity 124 and the second reservoir is configured to store the aspirated infusion fluid.
[43] Nevertheless, the closed loop configuration provides several advantages. For example, the closed loop configuration eliminates the requirement for a separate pump and a separate reservoir required for the aspiration process and the infusion process. Since only a single pump is used, the closed-loop configuration reduces energy requirements for operating the device 100. Also, the cost for an extra pump and an extra reservoir are avoided, thereby decreasing the overall cost of the device 100. Moreover, in the closed-loop configuration, the infusion fluid is continually taken out of the reservoir while simultaneously the reservoir 170 is continually filled through the aspirated infusion fluid. Since the same infusion fluid is continually recycled, there is no fluid loss, thereby increasing operational efficiency. Further, unlike in the open-loop configuration where the first reservoir is refilled and the second reservoir is emptied periodically, no refilling and emptying of the reservoir 170 is required in the closed loop configuration, thereby reducing the procedure time and complexity, and enhancing efficiency of the procedure.
[44] In an embodiment, the first port 141 of the hub 140 is also fluidically coupled to an inflation port 150 via a fourth conduit 181. The inflation port 150 facilitates inflation and deflation of the inflating element 120. An inflation device (e.g., a syringe) may be coupled to the inflation port 150. The inflation device is used to inject the inflation fluid into the inflating element 120 via the first lumen 131 to inflate the inflating device and withdraw the inflation fluid from the inflating element 120 via the first lumen 131 to deflate the inflating element 120. The inflation fluid may be a liquid or a gas. In an embodiment, the inflation fluid is a saline solution. The inflation fluid may also include a contrast dye to allow a surgeon to observe the passage of the inflation fluid. The first port 141 is fluidically coupled to the first lumen 131 of the shaft 130 so that the inflation fluid can flow from the inflation port 150 to the first lumen 131 and vice versa. Thus, the first port 141 of the hub 140 functions both as an inflation and infusion port. Accordingly, the first port 141 may include two openings (not shown), one opening coupled to the second conduit 183 and the other opening coupled to the fourth conduit 181. Though the depicted embodiment shows the same port being used for the inflation and infusion, in another embodiment, the hub 140 may include an additional port to couple with the fourth conduit 181 or with the second conduit 183.
[45] The second port 142 of the hub 140 acts as a guidewire port and is configured to receive the guidewire. The guidewire may be inserted from an opening provided in the second port 142. The opening is coupled to the fourth lumen 134 of the shaft 130 via a corresponding lumen (not shown) provided in the hub 140.
[46] Fig. 5 illustrates a flowchart of a method 500 of operating the device 100 according to an embodiment. The device 100 is used to fragmenting deposits such as, calcium, fibrin, and the like on a vessel and/or a valve of a patient.
[47] At step 501, the distal portion of the device 100 including the inflating element 120 is inserted into a patient’s body and navigated through the patient’s vasculature to a target site (e.g., an artery or a valve having calcified deposits), for example, over a guidewire. The inflating element 120 is in the deflated state at this stage.
[48] At step 502, upon reaching the target site, the inflating element 120 is inflated. To achieve this, the inflation port 150 is coupled to an inflation device. The inflation device inserts the inflation fluid into the first lumen 131 via the inflation port 150. The inflation fluid enters the channel 121 of the inflating element 120, causing the inflating element 120 to inflate.
[49] At step 503, the pump 160 is activated, for example, by coupling the pump 160 to a power supply. Upon activation, the pump 160 draws the infusion fluid from the reservoir 170 via the first conduit 185. The pump 160 drives the infusion fluid into the third lumen 133 at a high-pressure via the second conduit 183 and the first port 141. The infusion fluid is ejected from the apertures 193 in the form of jet sprays 195 at a very high pressure towards the inner layer 123 of the inflating element 120. When the jet sprays 195 impact the inner layer 123, pressure waves are generated by the inflating element 120. The pressure waves cause micro fragmentation of the deposits at the target site. The accumulated infusion fluid within the cavity 124 of the inflating element 120 is aspirated via the second lumen 132 of the shaft 130 into the reservoir 170 as explained earlier. The funnel-like shape of the inlet 132a of the second lumen 132 guides the infusion fluid into the second lumen 132 more efficiently. This process continues until the user is satisfied with the micro fragmentation. The user can observe the micro fragmentation of the deposits using any imaging technique such as, fluoroscopy. The reservoir 170 maintains an optimal flow of the infusion fluid for infusion and aspiration and prevents mixing of air into the infusion fluid by removing the air via the vent 171 for smooth operation of the device 100. The cycle of infusing and aspirating of the fluid repeats until the user is satisfied with the procedure. The frequency and/or energy of the high-pressure waves can be controlled as required by adjusting the speed of the pump 160. For example, the frequency and/or energy of the high-pressure waves may be increased by increasing the speed of the pump 160 (e.g., when hard deposits are encountered) and vice versa. Increasing the speed of the pump 160 increases the velocity of the stream of the infusion fluid, thereby increasing the energy of the jet sprays 195. As the energy with which the jet sprays 195 hit the inner layer 123 of the inflating element 120 is directly proportional to the frequency (or energy) of the high-pressure waves, the frequency/energy of the pressure waves also increases.
[50] At step 504, once desired fragmentation of the deposits is achieved, the pump 160 is deactivated, for example, switching off the pump or decoupling the pump 160 from the power supply. Before deactivating the pump 160, the flow of the infusion fluid into the sleeve 191 is terminated, for example, by using a switch such as a rotating knob (not shown) and remaining infusion fluid is completely aspirated from the cavity 124 of the inflating element 120.
[51] At step 505, when the cavity 124 of the inflating element 120 is emptied of the infusion fluid, the inflating element 120 is deflated. The inflation device may be coupled to the inflation port 150 to withdraw the inflation from the channel 121 of the inflating element 120, thereby causing the inflating element 120 in the deflated state.
[52] At step 506, the distal portion of the device 100 is withdrawn from the patient’s body.
[53] Fig. 6 illustrates a device 200 for fracturing vascular and valvular deposits, according to another embodiment of the present disclosure. The device 200 has a proximal end 200a and a distal end 200b. The device 200 includes a support element 210, an inflating element 220, a shaft 230, a hub 240, an inflation port 250, a pump 260 and a reservoir 270.Structure and functioning of the support element 210, the shaft 230, the hub 240, the inflation port 250, the pump 260 and the reservoir 270 can be referred from the support element 110, the shaft 130, the hub 140, the inflation port 150, the pump 160 and the reservoir 170, respectively and is not a repeated for the sake of brevity. The shaft 230 includes a first lumen, a second lumen 232, a third lumen and a fourth lumen similar to the first lumen 131, the second lumen 132, the third lumen 133 and the fourth lumen 134, respectively, of the shaft 130. The device 200 may be operated in a similar manner as explained with respect to Fig. 5.
[54] Referring to Figs. 6a-6b, the inflating element 220 is depicted in a deflated state and an inflated state, respectively. Similar to the inflating element 120 of the device 100, the inflating element 220 too has a multi-layer structure and includes an outer layer 222 and an inner layer 223 defining a channel 221 between the outer layer and the inner layer 223. The construction and functioning of the inflating element 220 are similar to the inflating element 120 and is not repeated for the sake of brevity.
[55] The device 100 includes a sleeve 291 disposed within a cavity 224 of the inflating element 220. The sleeve 291 is similar to the sleeve 191 of the device 100 except that instead of the plurality of apertures 193, the sleeve 291 includes a plurality of extensions 296. The extensions 296 have a tubular shape. The extensions 296 extends from the sleeve 291 towards the inner layer 223 of the inflating element 220. Each extension 296 has an opening at a distal end of the extension 296. The stream of infusion fluid enters the plurality of extensions 296 and jet sprays 295 are emitted from the openings of the extensions 296 towards the inner layer 223 of the inflating element 220. The inflating element 220 generates pressure waves in response to the impact of the jet sprays 295 on the inner layer 223 in a similar manner as described earlier. The openings of the extensions 296 being in closer proximity to the inner layer 223 of the inflating element 220, the energy loss of the jet sprays 295 is lower compared to that of the device 100, thereby further improving the efficiency of the device 200. In an embodiment, the extensions 296 slope away from respective proximal ends towards respective distal ends such that each extension 296 slopes from a proximal end of the extension 296 towards a distal end of the extension 296 such that each extension 296 makes a pre-defined angle with the sleeve 291. The pre-defined angle may range from 45° to 80°. In an example implementation, the pre-defined angle is 60°. Sloping structure of the extensions 296 enables a compact profile of the inflating element 220 in the deflated state so that the delivery of the inflating element 220 is easier. In an embodiment, in the inflated state, a distal portion of each extension 296 may be substantially perpendicular to the inner layer 223 of the inflating element 220 so that the jet sprays 295 impact the inner layer 223 in a straight line, further reducing the loss of energy of the jet sprays 295.
[56] The present disclosure presents several advantages over conventional pressure wave generating catheters. Since the jet sprays generated in the proposed device does not contact the vessels/valves directly, the proposed device reduces the risk of trauma caused to the inner walls of the vessels and leaflets of the heart valves. Due to the multi-layered structure of the inflating element allows for generating high impact for generating the pressure waves. Further, energy loss of the jet sprays due to the presence of inflation fluid in the conventional catheter systems is eliminated. Therefore, the proposed device has a significantly higher efficiency compared to conventional catheter systems. Further, the device of the present disclosure has lower power consumption compared to conventional devices producing shock waves using high-energy electrical pulses. The closed-loop configuration of the proposed device eliminates the need for extra pump and reservoir, thus reducing the number of components and leads to a simple design. The use of a single pump further reduces energy requirements of the device. The fracturing of the deposits can be precisely controlled by adjusting the speed of the pump. Overall, the device of the present disclosure has a simple design, is easy to use and has a high operating efficiency.
[57] 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 device (100, 200) for fragmenting valvular and vascular deposits, the device (100, 200) comprising:
a. an inflating element (120, 220) configured to be in an inflated state in response to receiving an inflation fluid, the inflating element (120, 220) comprising:
i. an outer layer (122, 222); and
ii. an inner layer (123, 223) defining a cavity (124, 224); the outer layer (122, 222) and the inner layer (123, 223) defining a channel (121, 221) therebetween, the channel (121, 221) configured to receive the inflation fluid;
b. a sleeve (191, 291) disposed within the cavity (124, 224) of the inflating element (120, 220), the sleeve (191, 291) configured to receive a stream of an infusion fluid and emit jet sprays (195, 295) of the infusion fluid directed towards the inner layer (123, 223) of the inflating element (120, 220); and
c. a shaft (130, 230) comprising:
i. a first lumen (131) coupled to a proximal end (120a) of the inflating element (120, 220) and configured to provide a passage for the inflation fluid into the channel (121, 221) of the inflating element (120, 220);
ii. a third lumen (133) coupled to a proximal end of the sleeve (191, 291) and configured to provide a passage for the stream of the infusion fluid into the sleeve (191, 291); and
iii. a second lumen (132) configured to provide a passage for aspirating the infusion fluid from the cavity (124, 224) of the inflating element (120, 220);
d. wherein the inflating element (120, 220) is configured to generate pressure waves (H) in response to the impaction of the jet sprays (195, 295) on the inner layer (123, 223).
2. The device (100, 200) as claimed in claim 1, wherein the sleeve (191) comprises a plurality of apertures (193) provided on an outer surface of the sleeve (191), wherein the jet sprays (195) are emitted from the plurality of apertures (193).
3. The device (100, 200) as claimed in claim 2, wherein each aperture (193) of the plurality of apertures (193) is in the form of a nozzle.
4. The device (100, 200) as claimed in claim 1, wherein the sleeve (291) comprises a plurality of extensions (296) extending from the sleeve (291) towards the inner layer (223) of the inflating element (220), each extension (296) of the plurality of extensions (296) comprises an opening at a distal end of the extension (296), wherein the jet sprays (295) are emitted from the openings of the plurality of extensions (296).
5. The device (100, 200) as claimed in claim 4, wherein each extension (296) slopes away from a proximal end of the extension (296) towards the distal end of the extension (296) and makes a pre-defined angle with the sleeve (291).
6. The device (100, 200) as claimed in claim 4, wherein a distal portion of each extension (296) is substantially perpendicular to the inner layer (223) of the inflating element (220) in the inflated state.
7. The device (100, 200) as claimed in claim 1, wherein the device (100, 200) comprises:
a. a hub (140, 240) coupled to the shaft (130, 230), the hub (140, 240) comprising:
i. a first port (141) fluidically coupled to the third lumen (133) of the shaft (130, 230); and
ii. a third port (143) fluidically coupled to the second lumen (132) of the shaft (130, 230);
b. a reservoir (170, 270) configured to provide storage for the infusion fluid and comprising a first port (176) and a second port (178), wherein the second port (178) of the reservoir (170, 270) is fluidically coupled to the third port (143) of the hub (140, 240);
c. a pump (160, 260) comprising an inlet port (161) fluidically coupled to the first port (176) of the reservoir (170, 270) and an outlet port (162) fluidically coupled to first port (141) of the hub (140, 240), the pump (160, 260) configured to:
i. draw the infusion fluid from the reservoir (170, 270) via the inlet port (161);
ii. drive the infusion fluid through the outlet port (162), thereby generating the stream of the infusion fluid; and
iii. configured to generate negative pressures in the reservoir (170, 270), causing the infusion fluid to be aspirated from the cavity (124, 224) of the inflating element (120, 220) into the reservoir (170, 270) via the second lumen (132) of the shaft (130, 230).
8. The device (100, 200) as claimed in claim 7, wherein the first port (141) of the hub (140, 240) is fluidically coupled to the first lumen (131) of the shaft (130, 230), wherein the device (100) comprises an inflation port (150, 250) fluidically coupled to the first port (141).
9. The device (100, 200) as claimed in claim 7, wherein the reservoir (170, 270) comprises a first chamber (173) configured to hold the infusion fluid and a second chamber (174) configured to hold the aspirated infusion fluid.
10. The device (100, 200) as claimed in claim 1, wherein the device (100, 200) comprises:
a. a hub (140, 240) coupled to the shaft (130, 230), the hub (140, 240) comprising:
i. a first port (141) fluidically coupled to the third lumen (133) of the shaft (130, 230); and
ii. a third port (143) fluidically coupled to the second lumen (132) of the shaft (130, 230);
b. a first pump coupled to the first port (141) of the hub (140, 240) and configured to generate the stream of the infusion fluid;
c. a first reservoir coupled to the first pump and configured to provides a storage to the infusion fluid;
d. a second pump coupled to the third port (143) of the hub (140, 240) and configured to generate a suction force to aspirate the infusion fluid from the cavity (124, 224) of the inflating element (120, 220); and
e. a second reservoir coupled to the second pump and configured to provide a storage for the aspirated infusion fluid.
11. The device (100, 200) as claimed in claim 1, wherein the second lumen (132) of the shaft (130, 230) comprises an inlet (132a) provided at a distal end of the second lumen (132) and disposed within the cavity (124, 224) of the inflating element (120, 220), the inlet (132a) configured to guide the infusion fluid within the cavity (124, 224) into the second lumen (132).