Description:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(Section 10 and Rule 13)

TITLE OF THE INVENTION
MEDICAL DEVICE

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

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

FIELD OF INVENTION
[1] The present disclosure relates to medical devices. More particularly, the present disclosure relates to a catheter delivery device.
BACKGROUND OF INVENTION
[2] A blood vessel, sometimes, becomes occluded or blocked by a plaque, a clot, a thrombus, an embolus, etc. which reduces the blood carrying capacity of the blood vessel. Such blockage of the blood vessel may lead to a serious and potentially deadly condition such as a myocardial infarction, a stroke, a pulmonary embolism, deep vein thrombosis, an atrial fibrillation, an infective endocarditis, etc. If not detected early or treated promptly, the occlusion can result in a life-threatening situation, including death.
[3] Conventionally, various surgical interventions are available for blocked blood vessels including, thrombectomy, atherectomy, arthrosclerosis, etc. Thrombectomy focuses on removing blood clots from arteries or veins to restore blood flow, while atherectomy targets removal of calcification from blood vessels, helping in the restoration of blood flow. These surgical interventions rely on mechanical means, such as, cutting, scraping, and/or drilling to remove thrombi and/or plaques. Additionally, to make the procedure more efficient, one or more lytic procedures maybe employed with a surgical intervention procedure for dissolving the thrombi and/or plaques. A lytic procedure uses a catheter for delivering one or more lytic medications such as thrombolytics or anticoagulants. The lytic medications are infused in a patient’s body to dissolve blood clots and/or calcified plaques during the procedure.
[4] Conventional devices used to perform the aforesaid procedures may suffer from uneven/ineffective delivery of lytic medications and/or fluids at the targeted site, particularly in cases of large or densely packed vessels. As a result, the conventional procedures can be long and ineffective. This may delay the restoration of normal blood flow. Furthermore, inconsistency in delivering the lytic medications can lead to incomplete lesion coverage and suboptimal outcomes. This incomplete break-down can further leave residual material in the targeted site, which can lead to persistent occlusion and necessitate further treatment.
[5] Hence, there is a need of a device that overcomes the problems associated with the conventional devices.
SUMMARY OF INVENTION
[6] Particular embodiments of the present disclosure are described herein below with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are mere examples of the disclosure, which may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
[7] The present disclosure relates to a medical device. The medical device includes a shaft, two or more strips and two or more lumens. The shaft includes body extending from a proximal end to a distal end. The two or more strips are arranged on an outer surface of the shaft. The two or more lumens extends at least partially from the proximal end to the distal end in the body of the shaft. Each of the two or more lumens are provided underneath a corresponding strip of the two or more strips. The two or more strips are configured to operate via at least one of a low power mode or a high-power mode. The low power mode is configured to mistify an infusion fluid. The high-power mode is configured to fragment an embolus.
BRIEF DESCRIPTION OF ACCOMPANYING DRAWINGS
[8] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[9] Fig. 1 depicts a device 10 having a shaft 100 and a hub 200, according to an embodiment of the present disclosure.
[10] Fig. 2 depicts an exploded view of a distal portion 100d of the shaft 100, according to an embodiment of the present disclosure.
[11] Fig. 3 depicts two or more strips 120, according to an embodiment of the present disclosure.
[12] Fig. 4 depicts a cross-sectional front view of the shaft 100, according to an embodiment of the present disclosure.
[13] Fig. 5 depicts a flowchart of a method 500 of operation of the device 10, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE DRAWINGS
[14] 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.
[15] 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.
[16] 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.
[17] Furthermore, the described includes, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific includes or advantages of a particular embodiment. In other instances, additional includes and advantages may be recognized in certain embodiments that may not be present in all embodiments. These includes and advantages of the embodiments will become more fully apparent from the following description and apportioned claims, or may be learned by the practice of embodiments as set forth hereinafter.
[18] In the context of the disclosure, the term “blockage and/or occlusion” refers to a condition of a vessel in an individual wherein a lumen of the vessel is obstructed due to factors, such as, thrombus buildup, calcified plaques, etc., resulting in at least partial impaired blood flow. The term “dissolving”/“dissolution” includes one or more of degradation of the clot, breaking of the clot and/or calcified plaque into micro-fragmented particles, etc.
[19] The current disclosure pertains to a medical device (or a device). The device is used in a medical procedure like, thrombectomy, atherectomy, etc. The device helps in targeted destruction of the blockage/occlusion in a blood vessel. The device is minimally invasive. In an exemplary embodiment, the device is a catheter delivery system. The device integrates the capabilities of infusing one or more lytic medications, generating mechanical agitation at the targeted site for fragmenting one or more blockages, and/or aspirating the fragmented residual particles. For example, the device of the present disclosure is used as an integral part of a catheter delivery system utilized for promptly infusing the fluids or medications responsible for dissolution/loosening of the thrombus or calcified plaque in a controlled manner within blood vessels and simultaneously aspiring the dissolved thrombus and calcified deposits. This reduces the need for multiple procedures and streamlines the treatment process. By consolidating multiple functions into a single device, the overall workflow is simplified, leading to improved patient outcomes and procedural efficiency. Additionally, the compact and portable design of the device allows healthcare specialists to use the device in a range of environments, ensuring consistent and effective treatment regardless of the location.
[20] In an exemplary embodiment, the catheter delivery system of the present invention uses two or more strips (hereinafter, referred as strips) for targeted destruction of thrombi and/or calcified plaques using ultrasonic waves at different frequencies. For instance, the strips act as an atomizer and convert an infusion fluid into mist particles using low-frequency ultrasonic waves. These mist particles are dispersed at the targeted site. The mist particles of the lytic medication penetrate deep inside the thrombus, enhancing the dissolution of the blockage compared to conventional delivery methods. This enables precise infusion of the drugs and/or fluids at the targeted site and ensures targeted and effective delivery of the drugs and/or fluids within the patient's body where treatment is needed. This further ensures better distribution and absorption of medications, enhancing therapeutic outcomes. The gentle delivery of mist particles also minimizes the mechanical impact on the surrounding tissues. The strips of the device not only act as atomizer but are also configured to generate mechanical agitation. For instance, the strips generate mechanical agitation using high-frequency ultrasonic waves for breaking the particles and/or clots into micro-fragments.
[21] Unlike the conventional techniques, the combination of the localized fluid delivery and mechanical agitation at the targeted site enhances the thoroughness of blockage removal, thereby enhancing overall treatment effectiveness. Further, the combination streamlines the procedure, potentially reducing the duration and complexity of the operation, and subsequently improving recovery times. By effectively breaking the blockages, the device can restore and maintain better vascular patency, ensuring improved blood flow post-procedure. Patients are likely to experience faster recovery times due to less trauma and shorter procedure durations. The device may be employed in both acute and chronic conditions, offering a comprehensive solution for different stages of thrombosis and vessel calcification. The effective mechanical agitation and comprehensive delivery of lytic medications ensure better removal of blockages, reducing the likelihood of re-occlusion. By employing the mechanical agitation and lytic medication, simultaneously, the device of the present disclosure addresses the challenges associated with the conventional devices, where conventional devices often struggle or fail in penetrating the dense calcified and/or tortuous lesions.
[22] Although, the device of the present disclosure is described with the example of thrombectomy and atherectomy, the teachings of the present disclosure are equally applicable to other infusion procedures (for example, intravenous fluid, medications, nutrients, chemotherapy infusions, etc.) and aspiration procedures (for example embolectomy, debulking, extracting phlegm) whether performed dependently or independently. The same is within the scope of the teachings of the present disclosure.
[23] Now referring to the figures, Fig. 1 illustrates an exemplary embodiment of a medical device 10 (or device 10). In an exemplary embodiment, the device 10 includes a shaft 100 and a hub 200. The shaft 100 may be a catheter, an introducer sheath, etc. In an exemplary embodiment, the shaft 100 is a catheter. The shaft 100 includes a body extending from a proximal end 100a to a distal end 100b, thereby defining a length of the shaft 100. The body of the shaft 100 is tubular and hollow from inside. The length and a diameter of the shaft 100 may range between 80 mm to 1500 mm and 3 French size (Fr) to 24 French size (Fr), respectively. In an embodiment, the length and the diameter of the shaft 100 is 1300 mm and 5 Fr, respectively. The shaft 100 may be made of a material such as, without limitation, polyether block amide (PEBA), polyether ether ketone (PEEK), polyamide, nylon, etc., or a combination thereof. In an exemplary embodiment, the shaft 100 is made of PEBA.
[24] The proximal end 100a of the shaft 100 is coupled to the hub 200. The hub 200 is an assembly of a top case and a bottom case. The top case and the bottom case may be provided with a suitable locking mechanism, such as, without limitation, cantilever snap joints, L-shaped snap joints, annular snap joints, U-shaped snap joints. In an exemplary embodiment, the top case is coupled to the bottom case using L-shaped joints.
[25] The top case and the bottom case may be made of any suitable material such as, without limitation, acrylonitrile butadiene styrene (ABS), nylon, high density polyethylene (HDPE), low density polyethylene (LPDE), polycarbonate. In an exemplary embodiment, the top case and the bottom case is made of polycarbonate.
[26] The hub 200 has a proximal end 200a and a distal end 200b. The proximal end 200a of the hub 200 includes two or more ports. In an exemplary embodiment, the two or more ports includes a first port 220, a second port 240 and at least one power connector port 260 (hereinafter referred as power connector port 260). The first port 220 provides passage for a guidewire into the shaft 100. The guidewire helps in navigating through intricate pathways of the vasculature system. The second port 240 functions as an input port configured to facilitate an infusion fluid.
[27] The power connector port 260 is electrically coupled to a suitable power supply (not shown). In an embodiment, the power supply may be an external DC power supply. In yet another embodiment, the power supply may be an external AC power supply. In an exemplary embodiment, the power connector port 260 is a power socket, to which a suitable power plug may be coupled for power supply.
[28] While the description discloses an embodiment with three ports, it is to be understood that the device may include at least two ports and may accommodate more than four ports, depending on the specific application and requirements.
[29] The distal end 200b of the hub 200 may be coupled to the proximal end 100a of the shaft 100 using techniques, such as without limitation, UV boding, adhesive bonding, heat bonding, solvent bonding, etc. In an exemplary embodiment, the hub 200 is coupled to the proximal end 100a of the shaft 100 using UV bonding.
[30] In an embodiment, the hub 200 is generally cuboidal in shape with a taper at the proximal end 200a and the distal end 200b. While the depicted embodiment includes tapers at ends, a person skilled in the art will appreciate that numerous variations to the shape of the hub can be made while practicing the inventive features of the present disclosure and the same are within the scope of the present disclosure.
[31] The distal end 100b of the shaft 100 is generally bowl-disc in shape and/or has a smooth surface. The bowl-disc shape of the distal end 100b of the shaft 100 ensures zero damage to the surrounding tissues. The portion of the shaft 100 adjoining the distal end is referred as a distal portion 100d. An exploded view of the distal portion 100d of the shaft 100 is illustrated in Fig. 2, according to an embodiment of the present disclosure.
[32] The shaft 100 includes two or more strips 120 (referred to as strips 120) on an outer surface of the shaft 100. The strips 120 may be coupled to the shaft 100 using techniques, such as, without limitation, adhesive bonding, laser welding, mechanical fastening, etc. In an exemplary embodiment, the strips 120 are coupled to the shaft 100 using adhesive bonding.
[33] In an exemplary embodiment, the distal end 100b of the shaft 100 includes one strip 120 while the distal portion 100d includes six strips 120, as shown in Fig. 2. Though the present disclosure includes a shaft with one strip at the distal end and six strips towards the distal portion, it should be appreciated that the shaft may include more than one strip at the distal end and one or more strips in the distal portion of the shaft.
[34] The shape of the strips 120 may be, without limitation, rectangular, circular, bowl-disc shape, concave, convex, ellipse, oval, etc. In an exemplary embodiment, the strip 120 provided at the distal end 100b, is bowl-disc in shape and the strips 120 provided towards the distal portion 100d are rectangular in shape. The strip 120 may have a length and a width ranging between 1 mm to 50 mm and 0.5 mm to 5 mm, respectively. In an exemplary embodiment, each strip 120 includes a length and a width of 10mm and 2mm, respectively. Though the strips described in the present disclosure are exemplarily rectangular in shape with specified dimensions, however, it should be understood that the strips may be configured in any suitable dimensions, provided that the functionality described herein achieved without deviating the teachings of the present disclosure.
[35] The strips 120 may be arranged in a pre-defined pattern, such as, without limitation, an axial configuration, a circumferential configuration, a slanted configuration, a wavy configuration, etc. or a combination thereof. In the depicted embodiment, the strip 120 at the distal end 100b is arranged circumferentially. The strips 120 provided with the distal portion 100d are equidistant from each other, running longitudinally along the length of the shaft 100, as shown in Fig. 2. This arrangement of the strips 120 helps in uniform distribution of the mechanical agitation and the infusion fluid at the targeted site. Though the strips 120 are shown to be equidistant, they may be arranged haphazardly.
[36] The strips 120 help in dissolving the clot and/or calcified portion in the vasculature. The strips 120 operate at one or more frequencies of ultrasonic waves to dissolve the clot(s) and/or calcified portion(s). For example, the strips 120 may receive an electric power varying between a first pre-defined voltage (e.g., low power mode) and a second pre-defined voltage (e.g., high power mode) depending upon requirement.
[37] The strips 120 are electrically coupled to the power connector port 260 using respective connecting wires, as explained later. The strips 120 receive an electric power at the first pre-defined voltage and the second pre-defined voltage from the power connector port 260. The first pre-defined voltage and the second pre-defined voltage may range between 6V to 24V and 24V to 72V, respectively.
[38] The strips 120 are configured to convert the electrical power to one or more ultrasonic waves. The one or more ultrasonic waves includes at least one low-frequency ultrasonic waves and at least one high-frequency ultrasonic waves. The at least one low-frequency ultrasonic wave is generated upon operating the strips 120 at the low power mode. For example, the strips 120 generate a first pre-defined frequency (e.g., a low frequency ultrasonic waves) upon receiving electric power at the first pre-defined voltage. The at least one high-frequency ultrasonic wave is generated upon operating the strips 120 at the high power mode. For example, a second pre-defined frequency (e.g., a high frequency ultrasonic waves) upon receiving electric power at the the second pre-defined voltage. The first pre-defined frequency and the second pre-defined frequency produced by the strips 120 may range between 1Hz to 3Hz and 3Hz to 22Hz, respectively.
[39] Although, each strip described in the present disclosure is configured to operate in both the first pre-defined voltage and the second pre-defined voltage for thrombectomy and atherectomy, the strip can be configured to operate in only one mode or more than two modes. In the latter case, the power settings may be adjusted as needed depending upon requirements of the medical procedures.
[40] Each strip 120 acts as an atomizer when operated at the first pre-defined voltage. The strip 120 generates the first pre-defined frequency that is used for converting an infusion fluid into mist. Further, the strip 120 generates high-frequency ultrasonic frequencies when operated in a high-power mode (i.e., the second pre-defined voltage). The high-frequency ultrasonic frequencies (i.e., the second pre-defined frequency) are employed to generate mechanical agitation at the targeted site. The mechanical agitation results in micro-fragmentation of the embolus in the blood vessels.
[41] Although the present disclosure describes embodiments with two or more strips operating in different power-modes, it should be appreciated that the strips may be configured to operate in a single power, either high-power mode or low-power mode. For example, some strips 120 may operate in low-power mode for mistification of the infusion fluid, while other strips 120 may operate in high-power mode for micro-fragmenting the clot and/or plaques.
[42] Fig. 3 illustrates an exemplary embodiment of one strip 120. In an exemplary embodiment, the strip 120 includes a first plate 120a and a second plate 120b. The first plate 120a may be of piezoelectric, biocompatible material, such as, without limitation, lead zirconate titanate (PZT), quartz, piezo-ceramic, crystal, barium titanate, etc. or a combination thereof. The second plate 120b may be made of biocompatible material, such as, without limitation, stainless steel, aluminum, cupronickel alloy (CuNi), etc. or a combination thereof. In an exemplary embodiment, the first plate 120a and the second plate 120b are made of a piezo-ceramic and CuNi material, respectively.
[43] The first plate 120a may be coupled to the second plate 120b using techniques including, without limitation, adhesive bonding, welding, etc. In an exemplary embodiment, the first plate 120a is coupled to the second plate 120b using adhesive bonding.
[44] The second plate 120b includes a plurality of pores 120c. The plurality of pores 120c generally have a microscopic size ranging between 0.5 microns to 5 microns. In an exemplary embodiment, the size of the plurality of pores 120c is 1 micron.
[45] Upon receiving the electrical power, the first plate 120a of the strip 120 vibrates and generates ultrasonic frequencies as described below.
[46] The first plate 120a is configured to operate either at low-ultrasonic frequencies or high-ultrasonic frequencies depending upon the mode it is subjected to. The first plate 120a transmits the vibrational energy to the second plate 120b. The second plate 120b is configured to use the vibrational energy in converting the infusion fluid into mist or micro-fragmenting the clot and/or calcified blockages depending upon the frequency of ultrasonic waves. The plurality of pores 120c is configured to disperse the mist at the target site. In an exemplary embodiment, the strips 120 provided towards the distal portion 100d propagate the ultrasonic waves in a parallel direction to a longitudinal axis of the shaft 100. While, the strip 120 provided at the distal end 100b propagates the ultrasonic waves in a perpendicular direction to the longitudinal axis of the shaft 100.
[47] In an exemplary embodiment, the infusion fluid is received by the strips 120 via two or more lumens 160 (hereinafter, lumens 160). The lumens 160 extend at least partially from the proximal end 100a to the distal end 100b of the shaft 100. A cross-sectional view of the shaft 100 is illustrated in Fig. 4. In the depicted embodiment, the shaft 100 include six lumens 160 arranged circumferentially within the body of the shaft 100.
[48] Each lumen 160 is provided underneath a corresponding strip 120 provided towards the distal portion 100d of the shaft 100. Each lumen 160 is precisely aligned with the corresponding strip 120. Each strip 120 is positioned in such a way that they communicate with the corresponding lumen 160, ensuring that each strip 120 is centered over its respective lumen 160. The lumens 160 are aligned with the strip 120 provided at the distal end 100b.
[49] The lumens 160 allow passage of the infusion fluid. The lumens 160 receive the infusion fluid from the second port 240 provided towards the proximal end 200a of the hub 200. Additionally, the lumens 160 help in coupling the strips 120 to the power connector port 260 of the hub 200. In an exemplary embodiment, the lumens 160 allow passage of the connecting wires. The connecting wire establishes the electrical coupling of the strips 120 with the power connector port 260. In an exemplary embodiment, the connecting wires are passed through the lumen 160. In another embodiment, the connecting wires are pre-fabricated within the tubular body of the shaft 100.
[50] As stated above, while the depicted embodiment provides lumens with each strip, in the embodiment where some of the strips operate only at high power mode, lumens may not be provided at all with such strips or may be provided only for passage of respective wires of such strips.
[51] The shaft 100 further includes a central lumen 180. The central lumen 180 is positioned centrally and is surrounded by the lumens 160. The central lumen 180 extends at least partially from the proximal end 100a to the distal end 100b of the shaft 100. Though the present disclosure describes an embodiment of a shaft with one central lumen, it should be appreciated that the shaft may include more than one central lumen.
[52] The central lumen 180 provides passage of the guidewire from the proximal end 100a to the distal end 100b of the shaft 100. The central lumen 180 receives the guidewire from the first port 220 of the hub 200. Additionally, the thrombus or the fragmented particles of calcium deposits may be aspirated through the central lumen 180 using a mechanism, such as, without limitation, suction force, etc.
[53] Fig. 5 depicts a flowchart for a method 500 of operation of the device 10, according to an embodiment of the present disclosure.
[54] At step 502, the device 10 is prepared for the intended purpose of removal of the blockage from the vasculature system. For this, the device 10 is coupled with a power source. Specifically, the power connector port 260 of the device 10 is coupled to the respective power plug for power supply.
[55] At step 504, the infusion fluid is injected into the lumens 160 of the shaft 100 through the second port 240.
[56] Thereafter, one of the first pre-defined voltage (i.e., low-power mode) or the second pre-defined voltage (i.e., high power mode) is initiated. A user may initiate such mode by use of a button, switch, etc. depending upon the requirement of the medical procedure for a suitable pre-defined time period.
[57] For example, in case where an infusion fluid is required to be infused, the user may configure the electric power at the first pre-defined voltage for a first pre-defined time period at step 506a. The first pre-defined time period may be controlled by the user depending upon the requirements of the medical procedure. Alternately, the first pre-defined time period may be pre-configured with the device 10.
[58] Upon receiving the electric power, the first plate 120a of the strips 120 vibrate and generate ultrasonic waves at the first pre-defined ultrasonic frequency. The vibrational energy of the first plate 120a is transmitted to the second plate 120b of the strips 120. As the infusion fluid flowing through the lumens 160 comes in contact with the strips 120, the ultrasonic waves induce rapid oscillations in the infusion fluid. The intense vibrations of the second plate 120b break the surface tension of the infusion fluid. This forms microscopic vacuum bubbles in the liquid, which collapses and produces tiny jets of liquid droplets, thereby forming mist of the infusion fluid.
[59] The mist is dispersed at the targeted site for dissolving the calcified and/or clotted region in the vasculature system, at step 506b. In an embodiment, the strip 120 provided at the distal end 100b, disperses the mists angularly at the target site at step 506b. This is due to the bowl-disc shape of the strip 120 at the distal end 100b. The strips 120, provided towards the distal portion 100d, disperse the mists at the target site in a parallel direction to the longitudinal axis of the shaft 100. The simultaneous action of the strip 120 at the distal end 100b and the strips 120 at the distal portion 100d ensures effective delivery of the infusion fluids at the targeted site. For example, in case where the blood vessels are densely blocked and/ or tortuous lesions (such as, concentric, eccentric, nodular lesions), the strips 120 ensure effective distribution of the lytic medications and provide better coverage of the lesions.
[60] At step 506c, post-dispersion of the infusion fluid at the target site in the step 506b, a determination is made by the user regarding whether the medical procedure is to be discontinued or the medical procedure requires the device 10 to be switched to the high-power mode. At step 506d, the device 10 may be turned off in case the procedure solely requires mistification of the infusion fluid at the target site.
[61] In the event where the strips 120 are required to be operated in high power mode directly post step 504 or after step 506b, the user may configure the electric power at the second pre-defined voltage for a second pre-defined time duration, at step 508a.
[62] Upon receiving the electric power, the strips 120 produce ultrasonic waves at the second pre-defined frequency. The ultrasonic waves hit the calcified and/or blocked region and induce rapid oscillations. This forms microscopic fragments of the calcium particles, thereby breaking the calcified and/or clotted region in the vasculature system. The combined effect of mistified infusion fluids and the mechanical agitation helps the shaft 100 in penetrating the densely blocked and/or tortuous lesions and enhances the thoroughness of blockage removal.
[63] At step 508b, the residual particles are aspirated. A suction force may be applied via the first port 220 from the proximal end 200a of hub 200 for aspiration of the residual particles. The residual particles are aspirated from the central lumen 180 of the shaft 100.
[64] Thereafter, the method 500 terminates as in step 506c, where the power supply is disconnected from the device 10 once the medical procedure is competed.
[65] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:WE CLAIM:
1. A medical device (10), comprising:
a. a shaft (100) having a proximal end (100a), a distal end (100b) and a body;
b. two or more strips (120) arranged on an outer surface of the shaft (100);
c. two or more lumens (160) extending at least partially from the proximal end (100a) to the distal end (100b) in the body of the shaft (100); and
wherein, each of the two or more lumens (160) are provided underneath a corresponding strip (120) of the two or more strips (120);
wherein the two or more strips (120) are configured to operate via at least one of a low power mode or a high-power mode, the low power mode is configured to mistify an infusion fluid, the high-power mode is configured to fragment an embolus.
2. The medical device (10) as claimed in claim 1, wherein of the two or more strips (120), one strip (120) is provided at the distal end (100b) of the shaft (100) and one or more strips (120) are provided towards the distal portion (100d) on the outer surface of the shaft (100).
3. The medical device (10) as claimed in claim 1, wherein the two or more strips (120) is arranged on the outer surface of the shaft (100) in at least one of an axial configuration, a circumferential configuration, a slanted configuration, a wavy configuration or combinations thereof.
4. The medical device (10) as claimed in claim 1, wherein the two or more strips (120) are configured to generate one or more of:
a. at least one low-frequency ultrasonic waves when operated via at least one of the low-power mode; and
b. at least one high-frequency ultrasonic waves when operated via at least one high-power mode.
5. The medical device (10) as claimed in claim 1 and claim 4, wherein each strip (120) comprises:
a. a first plate (120a) configured to vibrate upon receiving electrical power and convert the received electrical power into ultrasonic frequencies; and
b. a second plate (120b) coupled to the first plate (120a), the second plate (120b) including a plurality of pores 120c;
wherein, vibrational energy of the first plate 120a is transmitted to the second plate 120b;
wherein mist formed by the ultrasonic frequencies are dispersed by the plurality of pores 120c at the targeted site.
6. The medical device (10) as claimed in claim 5, wherein at least one of the first plate (120a) and the second plate (120b) is made of piezoelectric, biocompatible material.
7. The medical device (10) as claimed in claim 6, wherein the piezoelectric, biocompatible material is one of lead zirconate titanate (PZT), quartz, piezo-ceramic, crystal, barium titanate, stainless steel, aluminum, cupronickel alloy (CuNi), or a combination thereof.
8. The medical device (10) as claimed in claim 1, wherein the shaft (100) comprises a central lumen (180) positioned centrally in the shaft (100) surrounded by the two or more first lumens (160).
9. The medical device (10) as claimed in claim 1, wherein the device (10) includes a hub (200) coupled to the proximal end (100a) of the shaft (100), the hub (200) having two or more ports comprising:
a. a first port (220) coupled to the central lumen (180) of the shaft (100);
b. a second port (240) coupled to the two or more lumens (160) of the shaft (100); and
c. at least one power connector port (260) electrically coupled to the two or more strips (120) facilitating at least one of external DC power supply or external AC power supply.
10. The medical device (10) as claimed in claim 1, wherein the device (10) includes connecting wires, wherein the connecting wires are at least one of pre-fabricated within the body of the shaft (100) or pass through the respective two or more lumens (160).