Description:TECHNICAL FIELD
[0001] The present disclosure relates generally to the field of renal denervation; and more specifically, to a renal denervation device for performing renal denervation procedures.
BACKGROUND
[0002] Nowadays, renal denervation has emerged as a promising treatment for hypertension and other conditions related to over activity of sympathetic and parasympathetic nervous systems. The existing renal denervation procedures typically involve inserting a catheter into a renal artery and using radiofrequency energy to ablate the nerves surrounding the renal artery. However, the existing technologies and methods used for renal denervation has several limitations. For example, the conventional renal denervation systems often use monopolar electrodes, which require grounding pads to complete the electrical circuit. This can lead to undesired tissue damage as well as vascular damage or in other words surgical site damage and complications at a renal site (i.e., the surgical site). Additionally, the conventional renal denervation systems lack precise control and monitoring of the ablation process, potentially resulting in incomplete denervation or excessive tissue damage as well as vascular damage or in other words surgical site damage at the renal site. Moreover, the shape and material of electrode (i.e., stent) are major factors affecting the efficacy and safety of the renal denervation procedure. The existing electrode designs may not provide optimal contact with the arterial wall or uniform energy distribution. Furthermore, the catheters used to deliver such electrodes may lack the flexibility and manoeuvrability required for efficient navigation through the vasculature. The monitoring and assessing the progress of renal denervation procedures also presents challenges. The existing methods often rely on indirect measures of successful renal denervation, such as changes in blood pressure, which may not provide immediate feedback during the procedure. Thus, there exists a technical problem of suboptimal electrode designs, limited catheter manoeuvrability, and insufficient real-time monitoring of critical parameters, such as temperature and pressure during the renal denervation procedure. These limitations potentially compromise the safety and efficacy of renal denervation treatments.
[0003] Therefore, in light of the foregoing discussion, there exists a need to overcome the aforementioned drawbacks associated with the conventional renal denervation systems.
SUMMARY
[0004] The present disclosure provides a renal denervation device for performing renal denervation procedures. The present disclosure provides a solution to the existing problem of suboptimal electrode designs, limited catheter manoeuvrability, and insufficient real-time monitoring of critical parameters, such as temperature and pressure during the renal denervation procedure. These limitations potentially compromise the safety and efficacy of renal denervation treatments. An aim of the present disclosure is to provide a solution that overcomes at least partially the problems encountered in prior art, and provide an improved renal denervation device for performing renal denervation procedures with efficacy and safety.
[0005] The object of the present disclosure is achieved by the solutions provided in the enclosed independent claims. Advantageous implementations of the present disclosure are further defined in the dependent claims.
[0006] In one aspect, the present disclosure provides renal denervation device comprising:
a catheter body comprising:
a hollow stainless-steel tube having a distal end and a proximal end, wherein the hollow stainless-steel tube includes two separate conductive pathways and an insulating layer positioned between the two conductive pathways; and
a lumen within the hollow stainless-steel tube configured to house a balloon catheter, the balloon catheter being configured to supply irrigation fluid to regulate temperature at a renal site during renal denervation activity;
an electrode with a custom-shaped structure, electrically connected to one of the two separate conductive pathways at the distal end of the hollow stainless-steel tube;
an external energy source coupled to the proximal end of the hollow stainless-steel tube, configured to supply an electric current to the electrode via one of the two separate conductive pathways during the renal denervation activity; and
a first controller operatively connected to the lumen inside the hollow stainless-steel tube, configured to control the supply of irrigation fluid through the balloon catheter and the inflation and deflation of the balloon catheter at the renal site.
[0007] The disclosed renal denervation device manifests an efficient design of the electrode, catheter flexibility as well as sufficient real-time monitoring of critical parameters, such as temperature and pressure during the renal denervation procedure by virtue of temperature and pressure sensors arranged on the electrode. Consequently, an improved nerve ablation rate is achieved along with the lesser procedural time. The custom-shaped electrode allows for precise and targeted delivery of the electric current to the renal site, ensuring effective denervation. Secondly, the inclusion of the balloon catheter and the ability to supply irrigation fluid during the procedure to regulate the temperature, prevents any potential damage to surrounding tissues. This ensures the safety and well-being of the patient during the denervation activity. Furthermore, the separate conductive pathways and insulating layer within the hollow stainless-steel tube prevent any unwanted electrical interference, enhancing the accuracy and reliability of the renal denervation device. The first controller adds an additional layer of control and customization, allowing the medical professional to adjust the irrigation fluid supply and inflation and deflation of the balloon catheter according to the specific requirements of each patient. Overall, the renal denervation device provides a comprehensive and efficient solution for performing denervation procedures, improving patient outcomes and safety. Moreover, the disclosed renal denervation device covers a larger surface area for denervation in one slot in comparison to conventional denervation devices. Also, the disclosed renal denervation device can fit for different sizes of blood vessels in patients.
[0008] It is to be appreciated that all the aforementioned implementation forms can be combined. All steps which are performed by the various entities described in the present application as well as the functionalities described to be performed by the various entities are intended to mean that the respective entity is adapted to or configured to perform the respective steps and functionalities. It will be appreciated that features of the present disclosure are susceptible to being combined in various combinations without departing from the scope of the present disclosure as defined by the appended claims.
[0009] Additional aspects, advantages, features and objects of the present disclosure would be made apparent from the drawings and the detailed description of the illustrative implementations construed in conjunction with the appended claims that follow.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] Embodiments of the present disclosure will now be described, by way of example only, with reference to the following diagrams wherein:

FIG. 1A illustrates a renal denervation device in an inflated configuration, in accordance with an embodiment of the present disclosure;
FIG. 1B illustrates a renal denervation device in a deflated configuration, in accordance with an embodiment of the present disclosure;
FIG. 1C illustrates various exemplary components of a renal denervation device, in accordance with an embodiment of the present disclosure;
FIG. 2A illustrates piercing of distal tip portion of renal denervation device to a renal site in a human body, in accordance with an embodiment of the present disclosure;
FIG. 2B illustrates placement of an electrode at a renal site, in accordance with an embodiment of the present disclosure;
FIG. 2C illustrates placement of an electrode at a renal site, in accordance with another embodiment of the present disclosure;
FIG. 3 illustrates coating of a radio-opaque material on one or more edges of hexagonal cells of an electrode, in accordance with an embodiment of the present disclosure;
FIG. 4 represents an enlarged view of a balloon catheter, in accordance with an embodiment of the present disclosure;
FIG. 5A represents an enlarged cross-sectional view of a renal denervation device, in accordance with an embodiment of the present disclosure;
FIG. 5B represents an enlarged front cross-sectional view of a renal denervation device, in accordance with an embodiment of the present disclosure;
FIG. 6A illustrates two separate conductive pathways inside a renal denervation device, in accordance with an embodiment of the present disclosure;
FIG. 6B illustrates incoming current to a renal site and outgoing current from the renal site, in accordance with an embodiment of the present disclosure; and
FIG. 6C illustrates a current flowing path in a renal denervation device, in accordance with an embodiment of the present disclosure.
In the accompanying drawings, an underlined number is employed to represent an item over which the underlined number is positioned or an item to which the underlined number is adjacent. A non-underlined number relates to an item identified by a line linking the non-underlined number to the item. When a number is non-underlined and accompanied by an associated arrow, the non-underlined number is used to identify a general item at which the arrow is pointing.
DETAILED DESCRIPTION OF EMBODIMENTS
[0011] The following detailed description illustrates embodiments of the present disclosure and ways in which they can be implemented. Although some modes of carrying out the present disclosure have been disclosed, those skilled in the art would recognize that other embodiments for carrying out or practicing the present disclosure are also possible.
[0012] FIG. 1A illustrates a renal denervation device in an inflated configuration, in accordance with an embodiment of the present disclosure. With reference to FIG. 1A, there is shown a renal denervation device 100A in an inflated (expanded) configuration. The renal denervation device 100A comprises a catheter body 102, an electrode 104, an external energy source 106, and a first controller 108. The catheter body 102 comprises a hollow stainless-steel tube 110 and a lumen 112 within the hollow stainless-steel tube 110. The hollow stainless-steel tube 110 has a distal end 110A and a proximal end 110B. The hollow stainless-steel tube 110 includes two separate conductive pathways, for example, a first conductive pathway 114 and a second conductive pathway 116. There is further shown a plurality of temperature sensors 118 and a plurality of pressure sensors 120 arranged on the electrode 104 and a balloon catheter 122 housed within the lumen 112. The renal denervation device 100A and the hollow stainless-steel tube 110 are represented by dashed boxes, which are used for illustration purpose only.
[0013] The renal denervation device 100A may be referred to as a medical instrument designed to treat hypertension by reducing the activity of nerves in the renal arteries. Generally, a renal denervation procedure (or renal ablation procedure) is a minimally invasive, investigational procedure to treat hypertension (i.e., high blood pressure) which cannot be cured with other medical treatments. Such type of hypertension is known as resistant-hypertension. The dimensions of the renal denervation device 100A may vary depending on age of the patients. For example, in an implementation scenario, the length of the electrode 104 (i.e., active area) of the renal denervation device 100A may range from 5 to 7 cm for an adult patient. In another implementation scenario, the length of the electrode 104 (i.e., active area) of the renal denervation device 100A may range from 1 to 2 cm for a child patient.
[0014] The catheter body 102 may be referred to as an elongated tubular structure of a catheter that serves as the main framework and conduit for delivery of fluids, instruments, or devices within a body cavity or vascular site during medical procedures.
[0015] The electrode 104 may be referred to as a conductive component that is used to deliver or receive electrical signals or currents in various applications, such as medical devices, electronic circuits, or electrochemical processes. The electrode 104 may also be referred to as a stent, used to decrease sympathetic as well as parasympathetic nerve activity and hence, lowering the blood pressure. The electrode 104 may also be referred to as either an ablation electrode or a Nitinol tiny tube.
[0016] The external energy source 106 may be referred to as a device or system that provides energy, such as electricity, electromagnetic radiation, or mechanical force, to power or activate the electrode 104 of the renal denervation device 100A. Examples of the external energy source 106 may include, but are not limited to, a Radio Frequency (RF) energy source, a Microwave (MW) energy source, and the like.
[0017] The first controller 108 may be referred to as a device or system that is configured to control inflation and deflation of the balloon catheter 122. Examples of the first controller 108 may include, but are not limited to, an inflation bulb, a Latex-free bulb, a controlling switch, a rotating handle, and the like.
[0018] The catheter body 102 comprises the hollow stainless-steel tube 110 having the distal end 110A and the proximal end 110B. The hollow stainless-steel tube 110 is a flexible part of the catheter body 102 and is made up of a specific grade of stainless-steel, for example, SS 316L having the composition of, for example, Iron (Fe) as the base metal, 16-18% Chromium (Cr), 10-14% Nickel (Ni), 2-3% Molybdenum (Mo), 0.03% or less Carbon (C) and small amounts of manganese, silicon, phosphorus, and sulphur. The distal end 110A refers to an end point of the hollow stainless-steel tube 110 that is farthest away from a point of origin or attachment. The proximal end 110B refers to an end point of the hollow stainless-steel tube 110 that is closest to a point of origin or attachment.
[0019] The renal denervation device 100A comprises the catheter body 102. The catheter body 102 comprises the hollow stainless-steel tube 110 having the distal end 110A and the proximal end 110B, where the hollow stainless-steel tube 110 includes two separate conductive pathways and an insulating layer positioned between the two conductive pathways. The term "conductive pathways" refers to the routes or channels within the hollow stainless-steel tube 110 that allow the flow of electrical current to the electrode 104. The term "insulating layer" refers to a protective or isolating covering that prevents the passage of electrical current between the two conductive pathways.
[0020] In accordance with an embodiment, the two separate conductive pathways comprise the first conductive pathway 114 for incoming current from the external energy source 106 to the electrode 104 and the second conductive pathway 116 for outgoing current from the electrode 104 back to the external energy source 106. The hollow stainless-steel tube 110 is laser cut into two separate conductive pathways that is the first conductive pathway 114 and the second conductive pathway 116. The first conductive pathway 114 is configured to transfer the incoming current from the external energy source 106 to the electrode 104 (i.e., the stent) and further, to the renal site (i.e., vascular site of kidney) and the second conductive pathway 116 is configured to transfer the outgoing current from the renal site to the electrode 104 and back to the external energy source 106. The use of two separate conductive pathways in the renal denervation device 100A allows for a unidirectional flow of current, ensuring that the energy is delivered precisely to the renal site without any interference or loss of energy. Additionally, such configuration eliminates the requirement for a grounding pad, simplifying the denervation procedure and enhancing patient comfort. Overall, the device's design (i.e., design of the renal denervation device 100A) optimizes the current flow and enhances the effectiveness and safety of the renal denervation procedure.
[0021] In accordance with an embodiment, each of the two separate conductive pathways is configured in either a zigzag pattern or a sinusoidal waveform pattern within the hollow stainless-steel tube 110. The term “zigzag pattern or sinusoidal waveform pattern” refers to a pattern characterized by a series of sinusoidal wave turns that alternate in direction, resembling the shape of a series of interconnected "curved Z" or "curved V" shapes. The zigzag pattern comprises a series of small corners set at variable angles tracing a path between parallel lines. The gap between the two zigzag-shaped parts is filled with the insulative material that prevents the transfer of electrical energy between the two parts. The zigzag pattern can range from a highly regular and structured patterns to more freeform and loose designs.
[0022] The zigzag pattern configuration is chosen to enhance the flexibility of the renal denervation device 100A compared to other existing catheter systems. By cutting the hollow stainless-steel tube 110 in the two zigzag shaped conductive pathways, the hollow stainless-steel tube 110 enables the renal denervation device 100A to have enhanced flexibility and manoeuvrability during the renal denervation procedure. The zigzag pattern allows for easier navigation through the renal anatomy, enabling precise targeting of the desired areas for denervation. The insulative material filling the gap between the zigzag-shaped parts ensures that electrical energy is properly directed and isolated within the two conductive pathways.
[0023] The catheter body 102 further comprises the lumen 112 within the hollow stainless-steel tube 110 configured to house the balloon catheter 122, the balloon catheter 122 being configured to supply irrigation fluid to regulate temperature at a renal site during renal denervation activity. The term "lumen" refers to a hollow space or channel within a tubular structure (e.g., the hollow stainless-steel tube 110) through which fluids or other substances can flow. The term "balloon catheter" refers to a medical device that includes a flexible tube with an inflatable balloon at its tip, used for various procedures such as angioplasty or dilation of a narrowed blood vessel. The term "irrigation fluid" refers to a liquid that is used to lower the temperature of a specific area or device, typically by circulating or applying the irrigation fluid to the target area. The term "renal site" refers to a specific location or region within the kidneys. The term "renal denervation activity" refers to a process of disrupting or ablating nerve activity in the renal arteries or surrounding tissues, typically to treat conditions, such as hypertension. The balloon catheter 122 expands as the irrigation fluid is supplied to the renal site during renal denervation activity. The use of the balloon catheter 122 and the irrigation fluid within the hollow stainless-steel tube 110 allows for precise temperature regulation at the renal site during renal denervation activity. This ensures that the renal denervation procedure can be performed accurately and safely, minimizing the risk of thermal damage to the vascular site or surgical site while achieving the desired denervation effect.
[0024] Moreover, the catheter body 102 is configured to introduce two components of the renal denervation device 100A, from a femoral artery to a renal site, where the renal denervation procedure is performed to treat hypertension. The two components are, the hollow stainless-steel tube 110, which is laser-cut into two zigzag or sinusoidal shaped conductive pathways and the lumen 112 carrying the balloon catheter 122, where the balloon catheter 122 is configured to supply the irrigation fluid to regulate temperature at the renal site during renal denervation activity.
[0025] In accordance with an embodiment, the irrigation fluid is a cool saline solution. In an implementation scenario, the irrigation fluid is a cool saline water used to regulate temperature at the renal site during renal denervation activity.
[0026] The renal denervation device 100A further comprises the electrode 104 with a custom-shaped structure, electrically connected to one of the two separate conductive pathways at the distal end 110A of the hollow stainless-steel tube 110. The custom-shaped structure of the electrode 104 is designed to provide advantages over existing electrode technologies. The custom-shaped structure of the electrode 104 also, ensures efficient and controlled delivery of electrical energy to the renal site, enhancing the effectiveness of renal denervation procedures. The custom-shaped electrode structure, along with the zigzag pattern, improves the flexibility of the renal denervation device 100A compared to the conventional catheter systems. The improved flexibility enables smoother navigation through the renal site, reducing the risk of damage or discomfort to the patient. Additionally, the custom-shaped electrode structure and efficient energy delivery enhance the precision and effectiveness of the renal denervation procedure, leading to improved patient outcomes.
[0027] In accordance with an embodiment, the custom-shaped structure of the electrode 104 is a Bucky-shaped structure which is expandable in response to inflation of the balloon catheter 122 and compressible in response to deflation of the balloon catheter 122, and where the electrode 104 is configured to be disposed at the renal site when in operation during renal denervation activity. The term "Bucky-shaped structure" refers to a structure that resembles the shape of a buckyball, which is a spherical fullerene molecule composed entirely of Nickel (Ni) and Titanium (Ti) atoms arranged in a pattern of hexagons. The custom-shaped electrode of the renal denervation device 100A is designed in a Bucky shape. The electrode 104 can be inflated or deflated using the balloon catheter 122. When the supply of the irrigation fluid through the balloon catheter 122 is initiated, the balloon catheter 122 inflates, causing the Bucky-shaped electrode to expand and when the supply of the irrigation fluid through the balloon catheter 122 is stopped, the balloon catheter 122 deflates, causing the Bucky-shaped electrode to compress and return to its original position. The Bucky-shaped structure of the electrode 104 allows a controlled expansion and compression of the electrode 104, which is required for precise positioning of the electrode 104 at the renal site and controlled delivery of energy to the renal site. This enhances the effectiveness and accuracy of the renal denervation procedure, leading to improved patient outcomes. The compression and expansion of the electrode 104 is shown and described in detail, for example, in FIGs. 2B and 2C, respectively.
[0028] After the renal denervation procedure is performed, the supply of the electric current from the external energy source 106 and the supply of the irrigation fluid are switched off. The switching off the electric current supply and stopping the flow of the irrigation fluid is done to facilitate the safe and efficient handling of the renal denervation device 100A after the procedure. By deflating the balloon catheter 122 and retracting the catheter body 102 from the renal site to the femoral site, the renal denervation device 100A can be easily removed from the patient.
[0029] In accordance with an embodiment, the electrode 104 is a Nitinol-based electrode having a hexagonal mesh structure comprising a plurality of interconnected hexagonal cells. The term "Nitinol-based electrode" refers to an electrode made from a shape memory alloy composed primarily of nickel and titanium, which exhibits super elasticity and the ability to return to its original shape after deformation. The term "hexagonal mesh structure" refers to a three-dimensional arrangement of interconnected hexagonal cells, forming a network with a repeating hexagonal pattern. The term "interconnected hexagonal cells" refers to individual hexagonal units that are linked together, allowing for a continuous and seamless structure. The use of the Nitinol-based electrode with the hexagonal mesh structure results in more efficient and precise renal denervation. The interconnected hexagonal cells ensure a consistent and uniform distribution of current, allowing for effective treatment of the target lesions. Additionally, the use of Nitinol as the electrode material provides flexibility and durability to the renal denervation device 100A, enabling easier navigation through the renal anatomy. The hexagonal mesh structure of the electrode 104 is shown and described in detail, for example, in FIGs. 2B, 2C and 3.
[0030] In accordance with an embodiment, the electrode 104 comprises the plurality of temperature sensors 118 arranged on either at intersections or center of edges of a first set of hexagonal cells of the plurality of interconnected hexagonal cells of the hexagonal mesh structure, configured to measure temperature at the renal site and the plurality of pressure sensors 120 arranged on either at intersections or center of edges of the first set of hexagonal cells of the plurality of interconnected hexagonal cells of the hexagonal mesh structure, configured to measure pressure at the renal site. The plurality of temperature sensors 118 is strategically arranged either at intersections or center of edges of hexagonal cells of the hexagonal mesh structure. Each of the plurality of temperature sensors 118 is configured for precise monitoring of the temperature at the renal site which is required for determining the success of the renal denervation procedure and ensuring that the desired denervation is achieved. Similarly, the plurality of pressure sensors 120 arranged either at intersections or center of edges of hexagonal cells, is configured to accurately monitor and assess the progress and success of individual ablations and the overall renal denervation procedure. The use of the plurality of pressure sensors 120 in conjunction with the plurality of temperature sensors 118 eliminates the requirement for additional sensors, such as plasma nor-epinephrine levels, as the pressure sensors in conjunction with temperature sensors are sufficient for completing the renal denervation procedure effectively. The arrangement of the plurality of temperature sensors 118 and the plurality of pressure sensors 120 on the hexagonal mesh structure of the electrode 104 is shown and described in detail, for example, in FIGs. 2C, 3 and 5A.
[0031] In an implementation scenario, each of the plurality of temperature sensors 118 and each of the plurality of pressure sensors 120 are wireless sensors. By virtue of wireless nature, each of the plurality of temperature sensors 118 and each of the plurality of pressure sensors 120 may comprise an antenna to capture energy wirelessly from the electrode 104 in order to ensure proper functioning of each sensor. On getting sufficient amount of energy, each temperature sensor (or pressure sensor) gets switched ON, and measures the temperature (or pressure) of the renal site and sends a signal to a second controller (not shown in FIG. 1A) at a slightly distinctive frequency. The second controller may be configured to deduce the measured temperature (or pressure) value using the signal received at the slightly distinctive frequency and display the measured temperature (or pressure) value via a display device to an operator performing the renal denervation activity. The second controller and the display device are shown and described in detail, for example, in FIG. 1C.
[0032] In accordance with an embodiment, one or more edges of a second set of hexagonal cells of the plurality of interconnected hexagonal cells of the hexagonal mesh structure has a coating of a radio-opaque material. The term "radio-opaque material" refers to a substance or compound that possesses the ability to absorb or block X-rays or other forms of electromagnetic radiation, thereby rendering it visible under radiographic imaging techniques. The coating process involves applying the radio-opaque material to the specific edges of the hexagonal cells, ensuring that they are fully covered and visible under imaging techniques. The purpose of coating the one or more edges of the hexagonal cells with the radio-opaque material is to obtain improved visualization and localization of the renal denervation device 100A. This enables precise placement and monitoring of the device during renal denervation procedures, ensuring accurate treatment and reducing the risk of complications. Additionally, the radio-opaque coating facilitates post-procedural assessment and follow-up examinations by providing clear visibility of the device's position and any potential changes or issues that may arise. The coating of the one or more edges of the hexagonal cells with the radio-opaque material is shown and described in detail, for example, in FIG. 3.
[0033] The renal denervation device 100A further comprises the external energy source 106 coupled to the proximal end 110B of the hollow stainless-steel tube 110, configured to supply an electric current to the electrode 104 via one of the two separate conductive pathways during the renal denervation activity. By utilizing the external energy source 106 and the conductive pathways within the hollow stainless-steel tube 110, the renal denervation device 100A ensures the effective delivery of the electric current to the electrode 104. This facilitates the successful execution of the denervation procedure, leading to the desired therapeutic effects on the renal site.
[0034] The renal denervation device 100A further comprises the first controller 108 operatively connected to the lumen 112 inside the hollow stainless-steel tube 110, configured to control the supply of irrigation fluid through the balloon catheter 122 and the inflation and deflation of the balloon catheter 122 at the renal site. The purpose of controlling the supply of the irrigation fluid through the balloon catheter 122 is to maintain heat at the renal site during the denervation procedure. By supplying the irrigation fluid (i.e., the cool saline water), the balloon catheter 122 expands, which in turn expands the electrode 104 connected at the distal end 110A of hollow stainless-steel tube 110. This expansion is required for performing the renal denervation procedure effectively. The first controller 108, in conjunction with the irrigation fluid and balloon catheter 122, ensures that the irrigation fluid is supplied and the balloon catheter 122 is inflated and deflated as required, providing optimal conditions for the renal denervation procedure.
[0035] In accordance with an embodiment, the catheter body 102 comprises an outer insulation layer covering the hollow stainless-steel tube 110, wherein the outer insulation layer is biocompatible. The outer insulation layer is biocompatible to ensure compatibility with the human body and minimize any potential adverse reactions. The outer insulation layer ensures the safe and effective delivery of energy to the renal site, while the biocompatible material minimizes any potential harm or adverse reactions to the patient. The outer insulation layer is shown and described in detail, for example, in FIGs. 5A and 5B.
[0036] Moreover, as shown in the FIG. 1A, the balloon catheter 122 is in the inflated configuration and therefore, the electrode 104 is also in the expanded configuration.
[0037] In operation, the renal denervation device 100A, more specifically, the hollow stainless-steel tube 110 of the catheter body 102 is introduced from a femoral artery to the renal site using a standard catheterization procedure, under typical imaging techniques, like Computed Tomography (CT), Medical Resonance Imaging (MRI), X-ray, and the like. Thereafter, the external energy source 106 (or energy generator) is switched ON and therefore, current gets started to flow from the external energy source 106 to the electrode 104 (i.e., the Bucky-shape Nitinol tube stent) through the first conductive pathway 114 (having zigzag pattern) to the renal site. Simultaneously, the balloon catheter 122 is configured to supply the irrigation fluid for regulating heat or to maintain thermal status at the vascular site for successfully performing the renal denervation procedure in a desired way. By virtue of supplying the irrigation fluid, the balloon catheter 122 inflates causing the electrode 104 to expand as well for renal denervation. After performing the renal denervation procedure, the current supply from the external energy source 106 is switched off and also, the supply of the irrigation fluid is switched off using the first controller 108. When the supply of irrigation fluid is switched off, the balloon catheter 122 deflates causing the electrode 104 to compress. Thereafter, the hollow stainless-steel tube 110 of the catheter body 102 is retracted from the renal site to the femoral site and to outside of human body and this way, the renal denervation procedure gets completed.
[0038] FIG. 1B illustrates a renal denervation device in a deflated configuration, in accordance with an embodiment of the present disclosure. FIG. 1B is described in conjunction with elements from FIG. 1A. With reference to FIG. 1B, there is shown a renal denervation device 100B in a deflated (or crimped) configuration. The renal denervation device 100B is similar to the renal denervation device 100A (of FIG. 1A) except a difference. The difference is that the balloon catheter 122 is in the deflated position and therefore, the electrode 104 is in the compressed configuration in the renal denervation device 100B.
[0039] FIG. 1C illustrates various exemplary components of a renal denervation device, in accordance with an embodiment of the present disclosure. FIG. 1C is described in conjunction with elements from FIGs. 1A and 1B. With reference to FIG. 1C, there is shown a block diagram 100C that illustrates various exemplary components of the renal denervation device 100A (of FIG. 1A) in addition to the components shown in FIG. 1A. There is shown a second controller 124 operatively connected to the external energy source 106. The second controller 124 is further connected to a display device 126, a pressure sensor 128 and a memory 130.
[0040] As shown in the FIG. 1A, the renal denervation device 100A comprises the catheter body 102 comprising the hollow stainless-steel tube 110. The hollow stainless-steel tube 110 has the distal end 110A where the electrode 104 is attached and the proximal end 110B where the external energy source 106 is connected.
[0041] The second controller 124 may be referred to as an electronic device or system that is configured to manage and control specific functions of the external energy source 106 independently from the first controller 108. Examples of the second controller 124 may include, but are not limited to an integrated circuit, a processor, a co-processor, a microprocessor, a microcontroller, a central processing unit (CPU) and other processors or circuits.
[0042] The display device 126 may be referred to as a visual output device, such as a screen or monitor, that presents information or data in a visual format for an operator performing the renal denervation activity.
[0043] In an implementation scenario, the second controller 124 may be connected to the pressure sensor 128, for example, a sphygmomanometer, for monitoring the blood pressure of the patient before and after the renal denervation activity.
[0044] The memory 130 may include suitable logic, circuitry, interfaces and/or code that is configured to store machine code and/or instructions executable by the second controller 124. Examples of implementation of the memory 130 may include, but are not limited to, an Electrically Erasable Programmable Read-Only Memory (EEPROM), Random Access Memory (RAM), Read Only Memory (ROM), Hard Disk Drive (HDD), Flash memory, a Secure Digital (SD) card, Solid-State Drive (SSD), a computer readable storage medium, and/or CPU cache memory.
[0045] In accordance with an embodiment, the renal denervation device 100A comprises the second controller 124 operatively connected to the external energy source 106, configured to control the supply of electric current from the external energy source 106, and to display various parameters, including pressure and temperature at the renal site via the display device 126 to an operator performing the renal denervation activity. The second controller 124 is configured to provide control over the supply of electric current from the external energy source 106. This control ensures that the current flows properly from the external energy source 106 to the renal site and back, as required for the denervation procedure. Additionally, displaying parameters like pressure and temperature at the renal site serves the purpose of monitoring and assessing the progress and success of the individual ablations and the overall renal denervation procedure. The display of parameters, like pressure and temperature provides real-time feedback to the operator, allowing the operator to make informed decisions during the procedure. This further enhances the accuracy and effectiveness of the renal denervation activity, leading to improved outcomes for patients.
[0046] In addition to the display device 126, the pressure sensor 128 and the memory 130, the second controller 124 may be connected to other electrical circuits, such as power supply, and the like, which are not shown here, for sake of brevity.
[0047] Thus, the renal denervation device 100A manifests an efficient design of the electrode 104, catheter flexibility as well as sufficient real-time monitoring of critical parameters, such as temperature and pressure during the renal denervation procedure by virtue of the plurality of temperature sensors 118 and the plurality of pressure sensors 120 arranged on the electrode 104. Consequently, an improved nerve ablation rate is achieved along with the lesser procedural time. The custom-shaped electrode allows for precise and targeted delivery of the electric current to the renal site, ensuring effective denervation. Secondly, the inclusion of the balloon catheter 122 and the ability to supply irrigation fluid during the procedure to regulate the temperature, prevents any potential damage to surrounding vascular site or the surgical site. This ensures the safety and well-being of the patient during the denervation activity. Furthermore, the separate conductive pathways and insulating layer within the hollow stainless-steel tube 110 prevent any unwanted electrical interference, enhancing the accuracy and reliability of the renal denervation device 100A. The first controller 108 adds an additional layer of control and customization, allowing the medical professional to adjust the irrigation fluid supply and inflation and deflation of the balloon catheter 122 according to the specific requirements of each patient. Overall, the renal denervation device 100A provides a comprehensive and efficient solution for performing denervation procedures, improving patient outcomes and safety. Moreover, the renal denervation device 100A covers a larger surface area for denervation in one slot in comparison to conventional denervation devices. Also, the renal denervation device 100A can fit for different sizes of blood vessels in patients, however, the shape and size may vary according to situation of different blood vessels in patients.
[0048] FIG. 2A illustrates piercing of distal tip portion of renal denervation device to a renal site in a human body, in accordance with an embodiment of the present disclosure. FIG. 2A is described in conjunction with elements from FIGs. 1A, 1B and 1C. With reference to FIG. 2A, there is shown a vasculature portion of a renal site 202 of a human body. There is further shown that the distal end 110A of the hollow stainless-steel tube 110 of the catheter body 102 of the renal denervation device 100A is pierced through the vasculature portion of the renal site 202 of the human body.
[0049] FIG. 2B illustrates placement of an electrode at a renal site, in accordance with an embodiment of the present disclosure. FIG. 2B is described in conjunction with elements from FIGs. 1A, 1B, 1C and 2A. With reference to FIG. 2B, there is shown the placement of the electrode 104 (i.e., the stent) at the renal site for ablation of renal nerves. There is further shown that the electrode 104 is in deflated configuration and has a hexagonal mesh structure 204 (i.e., the Bucky shape). The Bucky shape of the electrode 104 can be obtained by use of laser cutting technique. The electrode 104 (i.e., the Nitinol-based electrode) is attached at the distal end 110A of the hollow stainless-steel tube 110. More specifically, the electrode 104 is electrically connected to one of the two conductive pathways obtained by dividing the hollow stainless-steel tube 110.
[0050] FIG. 2C illustrates placement of an electrode at a renal site, in accordance with another embodiment of the present disclosure. FIG. 2C is described in conjunction with elements from FIGs. 1A, 1B, 1C, 2A, and 2B. With reference to FIG. 2C, there is shown the placement of the electrode 104 (i.e., the stent) at the renal site for ablation of renal nerves. There is further shown that the electrode 104 is in inflated configuration and has the hexagonal mesh structure 204. There is further shown the plurality of temperature sensors 118 and the plurality of pressure sensors 120 are arranged on edges of hexagonal cells of the hexagonal mesh structure 204 of the electrode 104. The functioning of the plurality of temperature sensors 118 and the plurality of pressure sensors 120 has been described in detail, for example, in FIG. 1A.
[0051] FIG. 3 illustrates coating of a radio-opaque material on one or more edges of hexagonal cells of an electrode, in accordance with an embodiment of the present disclosure. FIG. 3 is described in conjunction with elements from FIGs. 1A, 1B, 1C, 2A, 2B and 2C. With reference to FIG. 3, there is shown that certain edges (represented by darker lines in FIG. 3) of hexagonal cells of the hexagonal mesh structure 204 of the electrode 104 are coated with the radio-opaque material. By coating certain edges of hexagonal cells of the hexagonal mesh structure 204 with the radio-opaque material, the electrode 104 (i.e., the stent) can be easily identified and tracked using imaging techniques, such as X-rays or fluoroscopy, which further allows the operator (i.e., a medical professional) to accurately position and monitor the renal denervation device 100A within the renal site. Furthermore, FIG. 3 represents an enlarged view of the electrode 104 in the inflated configuration.
[0052] FIG. 4 represents an enlarged view of a balloon catheter, in accordance with an embodiment of the present disclosure. FIG. 4 is described in conjunction with elements from FIGs. 1A, 1B, 1C, 2A, 2B, 2C and 3. With reference to FIG. 4, there is shown a catheter shaft 402 connected with the external energy source 106 at the proximal end 110B of the hollow stainless-steel tube 110. In an implementation scenario, the catheter shaft 402 may correspond to the hollow stainless-steel tube 110 of the catheter body 102 of the renal denervation device 100A. There is further shown that the balloon catheter 122 housed in the lumen 112 of the catheter body 102 is in the inflated configuration and hence, the electrode 104 is also in the expanded configuration (represented by darker lines in FIG. 4).
[0053] FIG. 5A represents an enlarged cross-sectional view of a renal denervation device, in accordance with an embodiment of the present disclosure. FIG. 5A is described in conjunction with elements from FIGs. 1A, 1B, 1C, 2A, 2B, 2C, 3 and 4. With reference to FIG. 5A, there is shown an enlarged cross-sectional view 500A of the renal denervation device 100A, which represents the lumen 112 inside the hollow stainless-steel tube 110 of the catheter body 102, an outer insulation layer 502 covering the hollow stainless-steel tube 110 and an irrigation fluid 504 carried by the balloon catheter 122 through the hollow stainless-steel tube 110 to the renal site. Moreover, the enlarged cross-sectional view 500A of the renal denervation device 100A represents the expanded configuration of the electrode 104 in which the plurality of temperature sensors 118 and the plurality of pressure sensors 120 are arranged on specific edges of hexagonal cells of the hexagonal mesh structure 204 of the electrode 104.
[0054] FIG. 5B represents an enlarged front cross-sectional view of a renal denervation device, in accordance with an embodiment of the present disclosure. FIG. 5B is described in conjunction with elements from FIGs. 1A, 1B, 1C, 2A, 2B, 2C, 3, 4 and 5A. With reference to FIG. 5B, there is shown an enlarged front cross-sectional view 500B of the renal denervation device 100A, which represents the lumen 112 inside the hollow stainless-steel tube 110 of the catheter body 102, the outer insulation layer 502 covering the hollow stainless-steel tube 110 and the irrigation fluid 504 carried by the balloon catheter 122 through the hollow stainless-steel tube 110 to the renal site.
[0055] FIG. 6A illustrates two separate conductive pathways inside a renal denervation device, in accordance with an embodiment of the present disclosure. FIG. 6A is described in conjunction with elements from FIGs. 1A, 1B, 1C, 2A, 2B, 2C, 3, 4, 5A and 5B. With reference to FIG. 6A, there is shown that the hollow stainless-steel tube 110 is divided into two separate conductive pathways using laser-cut technique, for example, the first conductive pathway 114 and the second conductive pathway 116. The first conductive pathway 114 has dashed or highlighted area and the second conductive pathway 116 has plane area. Each of the two conductive pathways is configured in either a zigzag pattern or a sinusoidal waveform pattern. Any other suitable design may also be used for each of the two conductive pathways. Moreover, the gap between the two conductive pathways is filled with an insulating layer 602 to prevent any transfer of electrical energy from the first conductive pathway 114 to the second conductive pathway 116. The first conductive pathway 114 is used for the incoming current (or energy) from the external energy source 106 (or energy generator) to the electrode 104 and to the renal site (i.e., the vascular site of the kidney) and the second conductive pathway 116 is used for outgoing current (or energy) from the renal site to the electrode 104 and back to the external energy source 106 for completing the current path. Consequently, no extra pads (or grounding pads) are required for completing the current path in contrast to the conventional catheter systems. Moreover, by virtue of having the two separate conductive pathways, the renal denervation device 100A manifests a bipolar nature which is advantageous over monopolar nature of conventional catheter systems. The bipolar devices (or instruments) cause less damage to the tissue than monopolar instruments. This is also observed from medical practice that the bipolar instruments are safer than the monopolar instruments in endoscopic procedures for colorectal lesions. Additionally, with the monopolar device, the current passes from the active electrode to the target lesions through the patient’s body and finally exits the patient via a return electrode. However, with the bipolar device, the current only passes through the tissue between the two electrodes of the instrument (i.e., the renal denervation device 100A). The bipolar instrument (i.e., the renal denervation device 100A) is advantageous because it can be used for endoscopic resection without application of a return electrode and can eliminate the possibility of return electrode burn and contra lateral colorectal wall burn thus, reducing cost and time.
[0056] FIG. 6B illustrates incoming current to a renal site and outgoing current from the renal site, in accordance with an embodiment of the present disclosure. FIG. 6B is described in conjunction with elements from FIGs. 1A, 1B, 1C, 2A, 2B, 2C, 3, 4, 5A, 5B and 6A. With reference to FIG. 6B, there is shown a first wire 604 for an incoming current or energy transfer from the external energy source 106 (or energy generator) to the electrode 104 (i.e., Nitinol tube stent) and to the renal site (i.e., the vascular site of the kidney) and a second wire 606 for outgoing current (or energy) from the renal site to the electrode 104 and back to the external energy source 106. There is further shown the arrangement of the plurality of temperature sensors 118 and the plurality of pressure sensors 120 on the edges of the one or more hexagonal cells of the hexagonal mesh structure 204 of the electrode 104.
[0057] FIG. 6C illustrates a current flowing path in a renal denervation device, in accordance with an embodiment of the present disclosure. FIG. 6C is described in conjunction with elements from FIGs. 1A, 1B, 1C, 2A, 2B, 2C, 3, 4, 5A, 5B, 6A and 6B. With reference to FIG. 6C, there is shown the flow of incoming current through the first conductive pathway 114 from the external energy source 106 to the electrode 104 and to the renal site and flow of outgoing current through the second conductive pathway 116 from the renal site to the electrode 104 and back to the external energy source 106. This way, a complete path for the current flow is obtained eliminating the requirement of the grounding pads. The darker portion line of the electrode 104 describes the hot area or un-insulated area of the electrode 104, and used to provide the current energy to the renal site to perform denervation procedure.
[0058] Modifications to embodiments of the present disclosure described in the foregoing are possible without departing from the scope of the present disclosure as defined by the accompanying claims. Expressions such as "including", "comprising", "incorporating", "have", "is" used to describe and claim the present disclosure are intended to be construed in a non-exclusive manner, namely allowing for items, components or elements not explicitly described also to be present. Reference to the singular is also to be construed to relate to the plural. The word "exemplary" is used herein to mean "serving as an example, instance or illustration". Any embodiment described as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments and/or to exclude the incorporation of features from other embodiments. The word "optionally" is used herein to mean "is provided in some embodiments and not provided in other embodiments". It is appreciated that certain features of the present disclosure, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the present disclosure, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable combination or as suitable in any other described embodiment of the disclosure.
, Claims:We Claim:
1. A renal denervation device (100A) comprising:
a catheter body (102) comprising:
a hollow stainless-steel tube (110) having a distal end (110A) and a proximal end (110B), wherein the hollow stainless-steel tube (110) includes two separate conductive pathways and an insulating layer (602) positioned between the two conductive pathways; and
a lumen (112) within the hollow stainless-steel tube (110) configured to house a balloon catheter (122), the balloon catheter (122) being configured to supply irrigation fluid (504) to regulate temperature at a renal site during renal denervation activity;
an electrode (104) with a custom-shaped structure, electrically connected to one of the two separate conductive pathways at the distal end (110A) of the hollow stainless-steel tube (110);
an external energy source (106) coupled to the proximal end (110B) of the hollow stainless-steel tube (110), configured to supply an electric current to the electrode (104) via one of the two separate conductive pathways during the renal denervation activity; and
a first controller (108) operatively connected to the lumen (112) inside the hollow stainless-steel tube (110), configured to control the supply of irrigation fluid (504) through the balloon catheter (122) and the inflation and deflation of the balloon catheter (122) at the renal site.

2. The renal denervation device (100A) as claimed in claim 1, wherein the renal denervation device (100A) comprises a second controller (124) operatively connected to the external energy source (106), configured to control the supply of electric current from the external energy source (106), and to display various parameters, including pressure and temperature at the renal site via a display device (126) to an operator performing the renal denervation activity.

3. The renal denervation device (100A) as claimed in claim 1, wherein the two separate conductive pathways comprise: a first conductive pathway (114) for incoming current from the external energy source (106) to the electrode (104) and a second conductive pathway (116) for outgoing current from the electrode (104) back to the external energy source (106).

4. The renal denervation device (100A) as claimed in claim 3, wherein each of the two separate conductive pathways is configured in either a zigzag pattern or sinusoidal waveform pattern within the hollow stainless-steel tube (110).

5. The renal denervation device (100A) as claimed in claim 1, wherein the irrigation fluid (504) is a cool saline solution.

6. The renal denervation device (100A) as claimed in claim 1, wherein the custom-shaped structure of the electrode (104) is a Bucky-shaped structure which is expandable in response to inflation of the balloon catheter (122) and compressible in response to deflation of the balloon catheter (122), and wherein the electrode (104) is configured to be disposed at the renal site when in operation during renal denervation activity.

7. The renal denervation device (100A) as claimed in claim 1, wherein the electrode (104) is a Nitinol-based electrode having a hexagonal mesh structure (204) comprising a plurality of interconnected hexagonal cells.

8. The renal denervation device (100A) as claimed in claim 7, wherein the electrode (104) comprises:
a plurality of temperature sensors (118) arranged on either at intersections or center of edges of a first set of hexagonal cells of the plurality of interconnected hexagonal cells of the hexagonal mesh structure (204), configured to measure temperature at the renal site; and
a plurality of pressure sensors (120) arranged on either at intersections or center of edges of the first set of hexagonal cells of the plurality of interconnected hexagonal cells of the hexagonal mesh structure (204), configured to measure pressure at the renal site.

9. The renal denervation device (100A) as claimed in claim 7, wherein one or more edges of a second set of hexagonal cells of the plurality of interconnected hexagonal cells of the hexagonal mesh structure (204) has a coating of a radio-opaque material.

10. The renal denervation device (100A) as claimed in claim 1, wherein the catheter body (102) comprises an outer insulation layer (502) covering the hollow stainless-steel tube (110), wherein the outer insulation layer (502) is biocompatible.