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

1. TITLE OF THE INVENTION:
ADJUSTABLE ABLATION DEVICE

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

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

FIELD OF INVENTION
[1] The present disclosure relates to an ablation system. More particularly, the present disclosure relates to an adjustable ablation device.
BACKGROUND OF INVENTION
[2] Ablation procedures play a crucial role in various medical interventions, including the treatment of tumors, arrhythmias, and pain management. Ablation involves the precise destruction or removal of abnormal or unwanted tissue using techniques such as heat, cold, or chemical agents.
[3] Ablation procedures offer minimally invasive alternatives for treating tumors, arrhythmias, and chronic pain. These procedures involve targeted destruction or removal of abnormal tissue using various energy modalities, including radiofrequency, microwave, and cryoablation.
[4] Conventionally, ablation procedures have been performed using fixed-length catheters or probes, which may limit the flexibility and adaptability of the treatment approach.
[5] It becomes challenging in dealing with tumors of different sizes and locations. Large tumors can be particularly tricky to treat because they often require extensive coverage. Conventional devices with fixed lengths struggle with this variability.
[6] Hence, there is a need for an ablation system that overcomes the problems associated with the conventional devices.
SUMMARY OF THE INVENTION
[7] The present invention relates to a ¬¬¬¬device for ablating tissues. In an embodiment, the device includes a rod and two or more electrode assemblies. The two or more electrode assemblies are provided on a distal portion of the rod. In an embodiment, each electrode assembly includes a plurality of tines and a control ring. A proximal end of the plurality of tines of each electrode assembly are coupled to the rod. Each control ring is slidably disposed over the plurality of tines of the respective electrode assembly between a first position and a second position. The device further includes two or more control elements. Each control element is coupled to a respective control ring. In response to a first trigger received by one of the control elements, the respective control ring is configured slide proximally towards the second position over the plurality of tines of a corresponding electrode assembly, causing the plurality of tines to unfurl.
[8] The foregoing features and other features as well as the advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
BRIEF DESCRIPTION OF DRAWINGS
[9] 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.
[10] Fig. 1a depicts an isometric view of a device 10 having two or more electrode assemblies in a deployed state, according to an embodiment of the present disclosure.
[11] Fig. 1b depicts an isometric view of the device 10 having the two or more electrode assemblies in a stowed state, according to an embodiment of the present disclosure.
[12] Fig. 1c depicts an isometric view of the device 10 having the two or more electrode assemblies in an undeployed state, according to an embodiment of the present disclosure.
[13] Figs. 2a – 2b depict various embodiments of the two or more electrode assemblies of the device 10, according to an embodiment of the present disclosure.
[14] Figs. 2c-2d depict side perspective views of a first electrode assembly 104a of the two or more electrode assemblies provided in the device 10, according to an embodiment of the present disclosure.
[15] Fig. 3a depicts a cross-sectional view of a proximal portion 300a of a handle 300 of the device 10, according to an embodiment of present disclosure.
[16] Fig. 3b depicts the device 10 when a first plurality of tines 108a are fully deployed, according to an embodiment of the present disclosure.
[17] Fig. 3c depicts the device 10 when the first plurality of tines 108a and a second plurality of tines 108b are fully deployed, according to an embodiment of the present disclosure.
[18] Fig. 3d depicts the device 10 when the first plurality of tines 108a, the second plurality of tines 108b and a third plurality of tines 108c are fully deployed, according to an embodiment of the present disclosure.
[19] Fig. 4a1 depicts a side view of a telescopic assembly provided in the device 10 when the two or more electrode assemblies are in the undeployed state, according to an embodiment of the present disclosure.
[20] Fig. 4a2 depicts a cross-sectional view of the telescopic assembly provided in the device 10 when the two or more electrode assemblies are in the undeployed state, according to an embodiment of the present disclosure.
[21] Fig. 4b1 depicts a side view of the telescopic assembly provided in the device 10 when the first electrode assembly 104a is exposed, according to an embodiment of the present disclosure.
[22] Fig. 4b2 depicts a cross-sectional view of the telescopic assembly provided in the device 10 when the first electrode assembly 104a is exposed, according to an embodiment of the present disclosure.
[23] Fig. 4c1 depicts a side view of the telescopic assembly provided in the device 10 when the first electrode assembly 104a and a second electrode assembly 104b are exposed, according to an embodiment of the present disclosure.
[24] Fig. 4c2 depicts a cross-sectional view of the telescopic assembly provided in the device 10 when the first electrode assembly 104a and the second electrode assembly 104b are exposed, according to an embodiment of the present disclosure.
[25] Fig. 4d1 depicts a side view of the telescopic assembly provided in the device 10 when the first electrode assembly 104a, the second electrode assembly 104b and a third electrode assembly 104c are exposed, according to an embodiment of the present disclosure.
[26] Fig. 4d2 depicts a cross-sectional view of the telescopic assembly provided in the device 10 when the first electrode assembly 104a, the second electrode assembly 104b and the third ablation electrode assembly 104c are exposed, according to an embodiment of the present disclosure.
[27] Fig. 4e1 depicts a cross-sectional view of the device 10 when the first electrode assembly 104a is exposed out of a needle 200 and is in the stowed state, according to an embodiment of the present disclosure.
[28] Fig. 4e2 depicts a cross-sectional view of the device 10 when the first electrode assembly 104a is in the fully deployed state, according to an embodiment of the present disclosure.
[29] Fig. 4f1 depicts a cross-section view of the device 10 when the first electrode assembly 104a is in the fully deployed, and the second electrode assembly 104b is exposed out of the needle 200 and is in the stowed state, according to an embodiment of the present disclosure.
[30] Fig. 4f2 depicts a cross-sectional view of the device 10 when the first electrode assembly 104a and the second electrode assembly 104b are in the fully deployed state, according to an embodiment of the present disclosure.
[31] Fig. 4g1 depicts a cross-sectional view of the device 10 when the first electrode assembly 104a and the second electrode assembly 104b are in the fully deployed state, and the third electrode assembly 104c is exposed out of the needle 200, according to an embodiment of the present disclosure.
[32] Fig. 4g2 depicts a cross-sectional view of the device 10 when the first electrode assembly 104a, the second electrode assembly 104b and the third electrode assembly 104c are in the fully deployed state, according to an embodiment of the present disclosure.
[33] Fig. 5a depicts a side view of a three-port connector 314 coupled to the telescopic assembly of the device 10, according to an embodiment of the present disclosure.
[34] Fig. 5b depicts a cross-sectional view of the three-port connector 314 coupled to the telescopic assembly of the device 10, according to an embodiment of the present disclosure.
[35] Fig. 6 depicts a flowchart of a method 1000 of operating the device 10, according to an embodiment of the present disclosure.
[36] Fig. 7 depicts various components of the device 10 when the ablation electrode assembly 100 is deployed within a targeted tissue 600, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[37] 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.
[38] 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.
[39] 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.
[40] 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 include 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 herein after.
[41] This current disclosure relates to an ablation device (hereinafter, device). The device is used in ablation procedures to ablate (remove or destroy) tissues, such as, tumors, abnormal tissues, etc. The device is used in minimally invasive procedures for treating tumors, arrhythmias, and chronic pain. The device includes two or more electrode assemblies and a control mechanism to control the two or more electrode assemblies. The two or more electrode assemblies (or electrode assemblies) aid in targeted destruction or removal of abnormal tissue using various energy modalities, including radiofrequency, microwave, and cryoablation. Each electrode assembly includes a plurality of tines having a pre-set shape (e.g., an umbrella shape). With the help of the control mechanism, the user can control the number of electrode assembly/assemblies that are deployed at the target site and the degree of deployment of the corresponding plurality of tines. This allows the users to customize the number of electrode assemblies to be deployed and control deployment state of the plurality of tines of each electrode assembly based upon the shape and size of the targeted tissues (e.g., tumors), thereby providing more extensive ablation coverage and enhancing procedural flexibility and precision.
[42] Now referring to the figures, Figs. 1a - 1c illustrates an exemplary embodiment of a device 10 for ablating tissues. The device 10 is used in an ablation procedure. The device 10 is configured to destroy targeted tissues (e.g., a tumor) of varying sizes within a patient during the ablation procedure. In an embodiment, as shown in Fig. 1a, the device 10 includes a rod 102, two or more electrode assemblies (interchangeably referred to as electrode assemblies), a needle 200 and a handle 300. The device 10 has a proximal end 10a and a distal end 10b.
[43] The rod 102 extends between the proximal end 10a and the distal end 10b of the device 10. The two or more electrode assemblies are coupled to the rod 102, which has been explained later. The rod 102 is configured to penetrate into the targeted tissue and allow the two or more electrode assemblies to reach the target area within the body. In an embodiment, the rod 102 includes a temperature sensor for monitoring the temperature of the tissue being ablated.
[44] The two or more electrode assemblies are configured to deliver energy to the target tissue of various sizes and shapes while minimizing damage to healthy surrounding tissues. In an exemplary embodiment, the device 10 includes three electrode assemblies, namely, a first electrode assembly 104a, a second electrode 104b and a third electrode assembly 104c, as shown in Fig. 1a. Though the present disclosure is explained using a device having three electrode assemblies, the teachings of the present invention extend to devices having more than three electrode assemblies and the same is within the scope of the present disclosure. The electrode assemblies are spaced apart. This helps in providing comprehensive coverage of the damaged tissue, thus facilitating tumor destruction of various sizes. The distance between successive electrode assemblies may be the same or different. In the depicted embodiment, the two or more electrode assemblies are spaced at uniform distance.
[45] In an embodiment, each electrode assembly includes a plurality of tines. The plurality of tines of each electrode assembly are arranged circumferentially around the rod 102 and are coupled to the rod 102 (as explained later). For example, the first electrode assembly 104a includes a first plurality of tines 108a, the second electrode assembly 104b includes a second plurality of tines 108b and the third electrode assembly 104c includes a third plurality of tines 108c.
[46] The plurality of tines (108a, 108b ,108c) of each electrode assembly (104a, 104b, 104c) are movable between a stowed state (undeployed), at least one partially deployed state and a fully-deployed state. In the stowed state, the plurality of tines (108a, 108b ,108c) of each electrode assembly (104a, 104b, 104c) are configured to collapse and align longitudinally along the longitudinal axis of the rod 102, as shown in Fig. 1b. The stowed state of the plurality of tines ensures compactness and facilitates ease of handling during the navigation of the device 10 and during insertion of the rod 102 with the electrode assemblies into the targeted tissue.
[47] Upon transition to the fully-deployed state, the plurality of tines is configured to unfurl from a respective distal end extending away from the longitudinal axis of the rod 102 (as shown in Fig. 1a). In the fully-deployed state, the corresponding electrode assembly takes a shape of an umbrella. In the at least one partially-deployed state, a partial length of the plurality of tines is configured to unfurl away from the longitudinal axis of the rod 102. The diameter of the plurality of tines in the at least one partially-deployed state is smaller than the diameter in the fully-deployed state.
[48] In an embodiment, the plurality of tines is biased to be in the fully-deployed state. In any one of the at least one partially-deployed state and the fully-deployed state, the plurality of tines are configured to contact target tissues and deliver energy to the target tissues. Due to the configurability of the plurality of tines between the stowed state, the at least one partially-deployed state and the fully deployed state, the device 10 provides a flexible and adaptive approach to ablating tissues of various sizes.
[49] The plurality of tines may be made of a biocompatible shape-memory material, such as, without limitation, nitinol (nickel-titanium alloy), copper-zinc aluminum alloy, copper aluminum nickel alloy, etc., or combination thereof. Each of the plurality of tines may be a wire, a strip, a braid of wires, etc. In an embodiment, the plurality of tines are strips made of nitinol. The plurality of tines are pre-shaped to be in a shape corresponding to the fully-deployed state. In other words, in absence of any constraining force, the plurality of tines is configured to return to the full-deployed state. Each tine of the plurality of tines may have predefined length and a predefined width. The predefined length and the predefined width of each tine may range between 5 mm and 50 mm, and 0.1 mm and 10 mm, respectively. In an embodiment, the predefined length and the predefined width of each tine is 20 mm and 0.8 mm, respectively.
[50] The two or more electrode assemblies are coupled to an excitation source and serve as conduits for delivering an excitation signal, such as, without limitation, radiofrequency (RF), microwave (MW), magnetic, laser, cryogenic, etc. to the targeted tissues. The excitation signal is configured to induce thermal changes within the targeted tissue. The thermal changes help in ablating the targeted tissues in the form of, e.g., necrosis, coagulation or modification. For example, in response to an RF or MW excitation signal (e.g., in the form of a series of pulses) received by at least one of the two or more electrode assemblies, AC currents flows from the corresponding plurality of tines to the targeted tissue. An electric resistance of the targeted tissue causes it to heat up, leading to thermal necrosis and destruction of the targeted tissue. In another example, in response to the magnetic excitation signal received by at least one of the two or more electrode assemblies, water molecules in the target tissue are configured to oscillate due to the change in the magnetic field. This generates frictional heat within the target tissue and leads to tissue ablation in the form of coagulation and necrosis. One of more parameters of the excitation signal, e.g., frequency, energy, number of pulses, pulse width, duty cycle, etc. in the case of an RF/MW excitation signal, may be chosen based upon the procedural requirements and the target tissue.
[51] In an embodiment, the device 10 includes two or more control elements. The number of control elements correspond to the number of electrode assemblies. Each control element is coupled to a respective electrode assembly, which has been explained later. Each control element is configured to deploy the respective electrode assembly at the target site and set the corresponding plurality of tines to one of the at least one partially-deployed state or the fully-deployed state and vice versa. The device 10 includes a roller 260. The roller 260 is coupled to the needle 200. An embodiment of the roller 260 has been explained later.
[52] The two or more control elements and the roller 260 are provided with the handle 300. The handle 300 is provided at the proximal end 10a of the device 10. The handle 300 includes a proximal portion 300a disposed at a proximal end of the handle 300, a distal portion 300b disposed at a distal end of the handle 300 and a central portion 300c. The central portion 300c is provided between the proximal portion 300a and the distal portion 300b of the handle 300. The proximal portion 300a generally has a hollow, cuboidal structure. The distal portion 300b and the central portion 300c generally have hollow, tubular structures.
[53] Referring to Fig. 1c, the needle 200 has a proximal end 200a, a distal end 200b and includes a lumen 204 extending therebetween. The distal end 200b of the needle 200 includes a tip 200c. The tip 200c is configured to pierce the patient’s skin so that the needle 200 can be inserted into the patient’s body percutaneously. In an embodiment, the tip 200c of the needle 200 includes a bevel. The bevel is an angled surface at the tip 200c that is configured to facilitate piercing the skin of the patient. The angulation of the bevel of the tip 200c may range between 0° and 180° degrees with respect to a longitudinal axis of the needle 200. In an embodiment, the bevel is angulated by 75° degrees with respect to the longitudinal axis of the needle 200. The needle 200 may be made of a biocompatible material such as, without limitation, stainless steel, nitinol, platinum, gold, silver, etc. In an exemplary embodiment, the needle 200 is made of SS316L. The length of the needle 200 may range between 50 mm and 250 mm. In an embodiment, the length of the needle 200 is 125 mm.
[54] The needle 200 is configured to be inserted percutaneously (i.e., through the skin) under any suitable imaging guidance system. The needle 200 may be designed to be radiopaque. Radiopacity of the needle 200 helps the healthcare professional to track the position of the tip 200c while advancing the needle 200 during the procedures. One or more radiopaque markers made of a radiopaque material, such as, without limitation, barium sulfate, bismuth compounds, tungsten, platinum-iridium, tantalum, etc. may be provided on the outer surface of the needle 200. In an embodiment, the needle 200 may include at least one annular slot 200d, as shown in Fig. 1c. The at least one annular slot 200d may be coated with a radiopaque material. Though successive annular slots of the at least one annular slot 200d are shown to be equidistant, it is possible that they may not be equidistant.
[55] The lumen 204 is configured to receive a partial portion of the rod 102 and provide a passage for a fluid (such as a saline liquid), which has been explained later. A diameter of the lumen 204 may range between 1 mm and 10 mm. In an embodiment, the diameter of the lumen 204 is 4 mm.
[56] The proximal end 200a of the needle 200 is coupled to the roller 260, which has been explained later. During the ablation procedure, the needle 200 is used to puncture the percutaneous layer of a patient and is advanced towards the targeted tissue. As the needle 200 approaches the targeted tissues, the needle 200 is gradually retracted into the handle 300 with the help of the roller 260 to expose (or deploy) a desired number of electrode assemblies (104a, 104b, 104c) of the two or more electrode assemblies. In response to the gradual retraction of the needle 200, the rod 102, which is partially disposed within the lumen of the needle 200, is configured to emerge from the distal end 200b of the needle 200, exposing the electrode assemblies. Upon retraction of the needle 200 by a pre-defined distance, all electrode assemblies are deployed (as shown in Fig. 1b). Note that the plurality of tines (108a, 108b, 108c) are in the stowed state.
[57] By manipulating the roller 260, the user is able to control the deployment of one or more of the electrode assemblies. Further, the deployment state of the plurality of tines of the deployed electrode assemblies may be controlled using the two or more control elements based upon the requirements, e.g., position, shape and size of the targeted tissues. For instance, when the size of the tumor is small, the user may deploy only the first electrode assembly 104a and the first plurality of tines 108a may be set in one of the at least one partially-deployed or the fully deployed state. For larger tumors, the user may deploy all three electrode assemblies (the first electrode assembly 104a, the second electrode assembly 104b and the third electrode assembly 104d) and the corresponding plurality of tines (viz., the first plurality of tines 108a, the second plurality of tines 108b and the third plurality of tines 108c) in the fully-deployed state. In another example scenario, where the shape of the tumor is irregular (say, the most distal part and the most proximal part of the tumor are larger and the middle part is smaller in size), the user may deploy the first electrode assembly 104a, the second electrode assembly 104b and the third electrode assembly 104c. The user may then set the first plurality of tines 108a and the third plurality of tines 108c in the fully-deployed state and the second plurality of tines 108b in a partially-deployed state. Thus, the user has the flexibility to exposed the desired number of electrode assembly/assemblies out of the two or more assemblies (104a, 104b, 104c) based upon the requirements. Further, the user may deploy the individual plurality of tines partially or completely depending upon the size and shape of the tumor. Partial deployment of the plurality of tines is beneficial in cases of smaller tumors, as it reduces the risk of unnecessary damage to surrounding healthy tissue while effectively ablating the targeted tissues. Thus, the device 10 provides flexibility to the user for treatment of a wide spectrum of tumor sizes while minimizing trauma to the surrounding healthy tissue during the ablation procedure. This improves effectiveness of the treatment, reduces the risk of complications and enhances patient comfort.
[58] Fig. 2a depicts the two or more electrode assemblies coupled to a distal portion of the rod 102, according to an embodiment of the present disclosure. The rod 102 may be solid or hollow. The length and diameter of the rod 102 may be between 10 mm to 500 mm and 0.1 mm to 5 mm, respectively. In an embodiment, the length and the diameter of rod 102 are 270 mm and 1 mm, respectively. The rod 102 may be made of a biocompatible material, such as, without limitation, copper-nickel alloy, titanium dioxides, etc., or a combination thereof. In an embodiment, the rod 102 is made of copper-nickel alloy. The rod 102 includes a distal tip 102c provided at a distal end of the rod 102. The distal tip 102c is configured to pierce the target site (or tissues) during the ablation procedure. In an embodiment, the distal tip 102c includes a bevel. The bevel is an angled surface that facilitates piercing of the targeted tissue.
[59] In an embodiment, an insulation coating may be applied on at least a partial length of the rod 102 to provide electrical insulation and prevent damage to surrounding health tissues. In an embodiment, the insulation coating is applied on the entire length of the rod 102 except the distal tip 102c. The insulation coating may include, without limitation, medical grade fluoropolymer coating, aqueous-based polytetrafluoroethylene (PTFE) coating, polyamide coating, solvent-based coating, etc. In an exemplary embodiment, the rod 102 is insulated using solvent-based PTFE coatings (PC 4006 Series and PC 403 Series).
[60] In an embodiment, the rod 102 includes a thermocouple sensor. In an example implementation, the rod 102 functions as a thermocouple sensor and is configured to sense the temperature of the targeted site that is being ablated and provides a corresponding electrical signal to a control unit (not shown). The control unit may be a microprocessor, a microcontroller or any other suitable circuit or computing device. An output device (e.g., a display) may be coupled to the control unit. The output device is configured to receive the signal from the control unit and display the sensed temperature.
[61] In an embodiment, each electrode assembly includes an inner ring (not shown), a band, a support ring and a control ring. For example, the first electrode assembly 104a includes a first inner ring (not shown), a first band 106a, a first support ring 109a and a first control ring 110a, the second electrode assembly 104b includes a second inner ring (not shown), a second band 106b, a second support ring 109b and a second control ring 110b, and the third electrode assembly 104c includes a third inner ring (not shown), a third band 106c, a third support ring 109c and a third control ring 110c, as shown in Fig. 2a.
[62] The first electrode assembly 104a, the second electrode assembly 104b and the third electrode assembly 104c may include same or different number of tines. In the depicted embodiment, the first electrode assembly 104a, the second electrode assembly 104b and the third electrode assembly 104c include the same number of tines (say, 8 – 10). For example, the first electrode assembly 104a, the second electrode assembly 104b and the third electrode assembly 104c have 8 tines (as shown in Fig. 2a). In another embodiment, the first electrode assembly 104a, the second electrode assembly 104b and the third electrode assembly 104c include different number of tines, e.g., 8 tines, 6 tines and 4 tines, respectively, as shown in Fig. 2b. Each electrode assembly having varying number of tines is able to accommodate a wider range of tumor sizes and increases flexibility of the device 10. A larger number of tines (say, 8) are more suitable for larger, more irregular, and/or infiltrative tumors, whereas a smaller number of tines (say, 4) are more effective for smaller or less irregular tumors. According to an embodiment, the number of tines of the two or more electrode assemblies gradually decrease from a distal-most electrode assembly (e.g., the first electrode assembly 104a in the depicted embodiment) to a proximal-most electrode assembly (e.g., the third electrode assembly 104c in the depicted embodiment).
[63] An embodiment of the first electrode assembly 104a is now explained with reference to Figs. 2c – 2d. It should be appreciated that structure and components of other electrode assemblies (e.g., the second electrode assembly 104b, the third electrode assembly 104c) of the two or more electrode assemblies can be understood from that of the first electrode assembly 104a and hence, is not repeated for the sake of brevity.
[64] The first inner ring (not shown) is coupled to the rod 102 at a desired position. The first inner ring generally has a hollow, tubular structure. In an embodiment, the first inner ring is coupled to the rod 102 using a bush. The bush is disposed between an inner surface of the first inner ring and an outer surface of the rod 102. The bush is made of an isolating material to provide isolation between the rod 102 and the inner ring. The first inner ring may be made of a material, such as, without limitation, medical grade metal such as stainless steel, nitinol, cobalt-chromium alloy, etc. In an embodiment, the first inner ring is made of SS316L. The first inner ring may have a predefined length and a predefined diameter ranging between 1 mm and 20 mm, and 0.1 mm and 5 mm, respectively. In an embodiment, the predefined length and the predefined diameter of the first inner ring are 5 mm and 1.1 mm, respectively.
[65] Each tine of the plurality of tines 108a includes a proximal end and a distal end. The first plurality of tines 108a of the first electrode assembly 104a are coupled to the first inner ring. Specifically, the proximal end of each tine 108a is coupled to an outer surface of the first inner ring. The proximal end of each tine 108a may be coupled to the rod 102 with the help of the first inner ring. The proximal end of each tine 108a may be coupled to the first inner ring using a technique, such as, without limitation, welding, adhesive bonding, etc. In an exemplary embodiment, the proximal end of each tine 108a is welded to the first inner ring.
[66] The first band 106a is disposed over a partial length of the first inner ring and is fixedly coupled to the first inner ring. The first band 106a has a hollow cylindrical structure, though it may have any other suitable shape. The first band 106a may be made of a biocompatible material, including, without limitation, medical grade stainless steel, copper, platinum, cobalt, titanium, etc. In an embodiment, the first band 106a is made of medical grade stainless steel. The first band 106a may have a predefined length and a predefined diameter ranging between 1 mm and 20 mm, and 0.1 mm and 5 mm, respectively. In an embodiment, the predefined length and the predefined diameter of the first band 106a are 5 mm and 1.3 mm, respectively.
[67] An inner surface of the first band 106a is coupled to the outer surface of the first inner ring in such a way that the proximal end of the first plurality of tines 108a are disposed between the outer surface of the first inner ring and the inner surface of the first band 106a. The first band 106a may be coupled to the first inner ring using techniques, such as, without limitation, welding, adhesive bonding, etc. In an exemplary embodiment, the inner surface of the first band 106a is welded to the outer surface of the first inner ring. A radiopaque coating may be applied on an outer surface of the first band 106a. This allows the medical practitioner to view the position of the first band 106a (and therefore, the position of the first electrode assembly 104a and the position of the first plurality of tines 108a).
[68] The first inner ring and the first band 106a are configured to securely hold the first plurality of tines 108a of the first electrode assembly 104a in place along the rod 102, ensuring its stability. An entire length of each tine 108a except the proximal end is free from the coupling.
[69] The first support ring 109a is disposed over a partial length of the first inner ring and fixedly coupled to the first inner ring. In an embodiment, the first support ring 109a generally has an annular disc like shape, though it may have any other shape. The first support ring 109a may be made of a material, such as, without limitation, medical grade stainless steel, nitinol, etc. In an embodiment, the first support ring 109a is made of SS316. The first support ring 109a may have a predefined diameter and a predefined thickness ranging between 1 mm and 20 mm, and 0.1 mm and 5 mm, respectively. In an embodiment, the predefined diameter and the predefined thickness of the first support ring 109a are 1.2 mm and 3 mm, respectively. An inner surface of the first support ring 109a is coupled to the outer surface of the first inner ring such that a part of the first plurality of tines 108a is disposed between the inner surface of the first support ring 109a and the outer surface of the first inner ring. In an embodiment, the first support ring 109a is welded to the first inner ring, though any other suitable technique may be used for the same purpose. The first support ring 109a supports the first control ring 110a when the first plurality of tines 108a are in fully-deployed state, which has been explained below.
[70] The first control ring 110a is slidably disposed over the first plurality of tines 108a. The first control ring 110a is configured to provide a constraining force to the first plurality of tines 108a and restrain the first plurality of tines 108a from gaining the pre-set shape in the stowed state and the at least one partially-deployed state. The first control ring 110a is configured to move axially between a first position and a second position. In an embodiment, in the first position, the first control ring 110a encompasses the distal end of the first plurality of tines 108a. And, in the second position, the first control ring 110a is disposed at the proximal end of the first plurality of tines 108a. At the second position, the first control ring 110a is disposed distal to the first support ring 109a.
[71] In response to the first control ring 110a encompassing the distal end of the plurality of tines 108a (i.e., the first control ring being in the first position), the first plurality of tines 108a are configured to experience a constraining force. Consequently, each tine 108a is configured to align longitudinally along the longitudinal axis of the rod 102. Upon experiencing the constraining force, the first plurality of tines 108a are restrained from gaining their pre-defined shape. Thus, at the first position of the first control ring 110a, the first plurality of tines 108a are configured to the stowed state.
[72] In response to the first control ring 110a being pulled in a proximal direction (i.e., towards the second position), the first control ring 110a is configured to slide over the first plurality of tines 108a. In response to the first control ring 110a being moved in the proximal direction, the distal end of the first plurality of tines 108a is configured to unfurl. In other words, in response to the first control ring 110a being moved in the proximal direction, the constraining force experienced by the first plurality of tines 108a is released. In response to the releasing of the constraining force, each tine 108a is configured to attain a curvature with respect to the longitudinal axis of the rod 102 as per pre-set shape and the first plurality of tines 108a unfurl. This is due to the shape-memory property of each tine 108a.
[73] In response to the first control ring 110a reaching the second position, the first plurality of tines 108a are configured to move to the fully-deployed state. In other words, in response to first control ring 110a reaching the second position (i.e., the first control ring 110a being disposed at the proximal end of the first plurality of tines 108a), the first plurality of tines 108a (except the proximal end) experiences no constraining force. In absence of constraining force, the first plurality of tines 108a are configured to unfurl and regain the pre-set shape (e.g., the umbrella shape) fully, i.e., the first plurality of tines 108a are configured to be in the fully-deployed state.
[74] In an embodiment, the first control ring 110a may also be configured to move to a third position. In the third position, the first control ring 110a is disposed over the first plurality of tines 108a between the proximal end and the distal end of the first plurality of tines 108a. In response to the first control ring 110a being disposed at the third position, a distal portion of the first plurality of tines 108a (i.e., a portion of the first plurality of tines 108a distal to the first control ring 110a) experiences no constraining force. While, a proximal portion of the first plurality of tines 108a (i.e., a portion of the first plurality of tines 108a proximal to the first control ring 110a) is configured to experience the constraining force. Consequently, the distal portion of the first plurality of tines 108a are configured to unfurl and regain the pre-set shape. And, the proximal portion of the first plurality of tines 108a are configured to remain constrained. Thus, when the first control ring 110a is in the third position, the first plurality of tines 108a are configured to partially unfurl, i.e., the first plurality of tines 108a are configured to be in the partially-deployed state.
[75] The first control ring 110a may be made of a biocompatible material, including, without limitation, medical grade metallic material (for example, stainless steel, cobalt, titanium, copper, etc.) or medical grade polymeric material (for example, polystyrene, resins, polytetrafluoroethylene (PTFE), etc.). In an embodiment, the first control ring 110a is made of medical grade stainless steel.
[76] Each electrode assembly is coupled to a respective control element. In an exemplary embodiment, the device 10 includes a first control element 306a, a second control element 306b and a third control element 306c. Specifically, the first control ring 110a, the second control ring 110b, the third control ring 110c are coupled to the first control element 306a, the second control element 306b and the third control element 306c, respectively.
[77] In an embodiment, the control ring of each electrode assembly is coupled to a corresponding control element via a control wire or any other equivalent coupling technique. Each control wire helps in moving the corresponding control ring between the first and the second position, which has been explained later. In the depicted embodiment, the first control ring 110a is coupled to the first control element 306a using a first control wire 114a, the second control ring 110b is coupled to the second control element 306b using a second control wire 114b and the third control ring 110c is coupled to the third control element 306c using a third control wire 114c. The first control wire 114a, the second control wire 114b and the third control wire 114c are coupled to the first control ring 110a, the second control ring 110b and the third control ring 110c, respectively. Specifically, a distal end of each control wire is coupled to a corresponding control ring (as illustrated in Fig. 2d for the first control ring 110a and the first control wire 114a).
[78] In an embodiment, the first control ring 110a includes a spiral groove A1. The first control wire 114a is wrapped around the spiral groove A1 and is fixedly coupled to the first control ring 110a. The first control wire 114a may be coupled to the first control ring 110a using techniques, such as, without limitation, adhesive bonding, welding, soldering, etc. In an exemplary embodiment, the first control wire 114a is coupled to the first control ring 110a using welding technique. Providing the spiral groove A1 in the first control ring 110a and disposing the first control wire 114a in the spiral groove A1 provides stability and facilitates a smooth and controlled movement of the first control ring 110a. Similarly, the second control wire 114b is coupled to a spiral groove (not shown) of the second control ring 110b and the third control wire 114c is coupled to a spiral groove (not shown) of the third control ring 110c using the similar technique.
[79] The first control wire 114a extends from the first control ring 110a, passes through the first support ring 109a, the first band 106a, the second support ring 109b, the second band 106b, the third support ring 109c and the third band 106c, and is coupled to the first control element 306a. In an embodiment, the first support ring 109a, the first band 106a, the second support ring 109b, the second band 106b, the third support ring 109c and the third band 106c include a respective hole for receiving the first control wire 114a. The second control wire 114b and the third control wire 114c are similarly coupled to the second control ring 110b and the third control ring 110c, respectively.
[80] The control wires may have a desired shape, for example, cylindrical, cuboidal, flat, etc. In an example implementation, the control wires have cylindrical shape. Each control wire may be made of a material, such as, without limitation, medical grade metallic material (for example, stainless steel, cobalt, titanium, copper, etc.) or medical grade polymeric material (e.g., polystyrene, resins, polytetrafluoroethylene (PTFE), etc.). In an embodiment, each control wire is made of medical grade stainless steel. Each control wire may include a respective predefined length. The length of first control wire 114a is longer than the length of the second control wire 114b, which in turn is larger than the length of the third control wire 114c. The predefined length of the first control wire 114a, the second control wire 114b and the third control wire 114c may range between 100 mm and 150 mm, 90 mm and 140 mm, and 80 mm and 130 mm, respectively. In an exemplary embodiment, the predefined length of the first control wire 114a, the second control wire 114b and the third control wire 114c are 140 mm, 130 mm and 120 mm, respectively.
[81] A proximal end of each control wire is coupled to the corresponding control element. In an exemplary embodiment, each control element is a sliding button. For the sake of simplicity, the first control element 306a, the second control element 306b and the third control element 306c are hereinafter interchangeably referred to as the first sliding button 306a, the second sliding button 306b and the third sliding button 306c, respectively. It should be understood that other functionally equivalent structures may be used instead of the sliding buttons without deviating from the scope of the present disclosure. Each control wire (viz., the first control wire 114a, the second control wire 114b and the third control wire 114c) is coupled to a corresponding control element using a technique, such as, adhesive bonding or welding. In an embodiment, a proximal end of each control wire (first control wire 114a, the second control wire 114b and the third control wire 114c) is coupled to the respective control element (the first sliding button 306a, the second sliding button 306b and the third sliding button 306c), respectively, using adhesive bonding.
[82] Each control element helps in controlling the movement of the corresponding control ring and thereby, controlling the degree of deployment of the plurality of tines of the respective electrode assembly between the stowed state, the at least one partially deployed state and the fully-deployed state and vice versa. In an embodiment, the two or more control elements are provided in the proximal portion 300a of the handle 300. A cross-sectional view of the proximal portion 300a of the handle 300 is illustrated in Fig. 3a.
[83] In an embodiment, the proximal portion 300a includes two or more slots, for example, a first slot 312a, a second slot 312b and a third slot 312c. The first slot 312a, the second slot 312b and the third slot 312c are provided on a top surface of the proximal portion 300a of the handle 300. The first slot 312a, the second slot 312b and the third slot 312c are configured to a receive the first control element 306a, the second control element 306b and the third control element 306c, respectively.
[84] Each control element is movable within the corresponding slot between a distal position X and a proximal position Y. In the depicted embodiment, the first sliding button 306a, the second sliding button 306b and the third sliding button 306c move within a first slot 312a, a second slot 312b and a third slot 312c, respectively, as shown in Fig. 3a. Each of the control elements is configured to receive a trigger to move within the corresponding slots. In other words, a trigger may be provided by the user to move the control elements within the corresponding slots. For example, a first trigger may be provided to move any of the control elements from the X position to the Y position. And, a second trigger may be provided to move any of the control elements from the Y position to the X position. The distal position X and the proximal position Y of each sliding button corresponds to the stowed state and the fully-deployed state, respectively, of the respective electrode assembly.
[85] In response to any one or the control elements (e.g., the first control element 306a, the second control element 306b and the third control element 306c) being at the distal position X within the respective slots (e.g., 312a, 312b, 312c), causes the plurality of tines (e.g., 108a, 108b, 108c) of the corresponding electrode assembly (e.g., 104a, 104b, 104c) to be in stowed state. And, in response to any one of the control elements (e.g., the first control element 306a, the second control element 306b and the third control element 306c) being at the proximal position Y within the respective slots (e.g., 312a, 312b, 312c), causes the plurality of tines (e.g., 108a, 108b, 108c) of the respective electrode assembly (e.g., 104a, 104b, 104c) to be in the fully deployed state.
[86] In an embodiment, each control element is configured to be set in at least one intermediate position between the distal position X and the proximal position Y. In response to the control element being set in the at least one immediate position, the corresponding control ring is at one of the third positions, causing the plurality of tines of the corresponding electrode assembly to be set in the one of the partially-deployed states.
[87] In response to a first trigger received by one of the control elements (306a, 306b, 306c) to move from the distal position X to the proximal position Y, the corresponding control wire (114a, 114b, 114c) is configured to be pulled in the proximal direction. In response to the corresponding control wire (114a, 114b, 114c) being pulled in the proximal direction, the respective control ring (110a, 110b, 110c) slides proximally from the first position to the second position on the plurality of tines (108a, 108b, 108c) of the corresponding electrode assembly (104a, 104b, 104c), causing the plurality of tines (108a, 108b, 108c) to be in fully-deployed as described earlier.
[88] For example, in response to the first trigger received by the first control element 306a to move from the distal position X to the proximal position Y, the first control wire 114a is pulled in the proximal direction, causing the first control ring 110a to move in the proximal direction from the first position to the second position (i.e., the first control ring 110a slides over the first plurality of tines 108a). Consequently, the first plurality of tines 108a unfurl fully and attain the fully-deployed state as explained earlier (as shown in Fig. 3b). The first band 106a prevents further proximal movement of the first control ring 110a, i.e., the first band 106a acts as a stopper for the first control ring 110a.
[89] Similarly, the movement of the second control element 306b and the third control element 306c from the respective distal position X to the respective proximal position Y, the second plurality of tines 108b of the second electrode assembly 104b and the third plurality of tines 108c of the third electrode assembly 104c, respectively, are configured to unfurl fully and attain the fully-deployed state. Fig. 3c illustrates the second control element 306b in the proximal position Y and the second plurality of tines 108b in the fully-deployed state. Fig. 3d illustrates the third control element 306c in the proximal position Y and the third plurality of tines 108c in the fully-deployed state.
[90] In response to the second trigger received by one of the control elements (306a, 306b, 306c) to move from the proximal position X to the distal portion Y, the corresponding control wire (114a, 114b, 114c) is configured to be pushed in the distal direction. In response to the corresponding control wire (114a, 114b, 114c) being pushed in the distal direction, the respective control ring (110a, 110b, 100c) slides distally from the second position to the first position on the plurality of tines (108a, 108b, 108c) of the corresponding electrode assembly (104a, 104b, 104c), causing the plurality of tines to be in stowed state as described earlier.
[91] To set the plurality of tines 108a – 108c of any of the electrode assemblies 104a – 104c in the partially-deployed state, the corresponding control element 306a – 306c is set at the intermediate position (a position between the proximal position Y and the distal position X). In response to the setting of the control element 306a – 306c in the intermediate position, the corresponding control ring 110a – 110c is configured to be in the third position (i.e., a position between the first position and the second position). In response to the control ring being positioned at the third position, the respective plurality of tines 108a – 108c are configured to unfurl partially and attain the partially-deployed state, as explained earlier. Thus, the user is able to control the deployment state of the plurality of tines of an individual electrode assembly as desired by manipulating the position of the respective control element. This provides a control over the deployment (no deployment, partial deployment or full deployment) of the plurality of tines of the electrode assemblies, thereby enabling users to adjust the degree of deployment the electrode assemblies according to the target tissue while minimizing damage to surrounding healthy tissues.
[92] In an embodiment, a notch (not shown) may be provided within each of the slots corresponding to the intermediate position. The notch is configured to lock the respective control element at the intermediate position. Though the depicted embodiment shows only one intermediate position for the control elements (and one third position for the control rings), more than one intermediate position may be designed for the control elements (and more than one third position for the control rings) and consequently, varying degrees of partial deployment for the plurality of tines may be realized, giving additional flexibility to the user.
[93] In addition to controlling the deployment state of the plurality of tines of the electrode assemblies, the device 10 also allows the user to control the number of electrode assemblies to be deployed at the target site. In an embodiment, the device 10 includes a roller 260 and a telescoping assembly to control the deployment of the electrode assemblies.
[94] The telescopic assembly is disposed within a distal portion 300b of the handle 300. The telescoping assembly includes an outermost tube provided at a proximal end of the telescopic assembly, an innermost tube provided at a distal end of the telescopic assembly and one or more intermediate tubes. The number of tubes in the telescopic assembly are one more than the number of electrode assemblies. The tubes of the telescopic assembly form two or more pairs of adjacent tubes telescopically coupled to each other.
[95] In the depicted embodiment, the telescopic assembly includes four tubes, namely, a first tube 250a, a second tube 250b, a third tube 250c and a fourth tube 250d. The first tube 250a is the outermost tube, fourth tube 250d is the innermost tube, and the second tube 250b and the third tube 250c are the intermediate tubes. The first tube 250a and the second tube 250b form one pair of adjacent tubes with the second tube 250b being the inner tube and the first tube 250a being the outer tube. Similarly, the second tube 250b and the third tube 250c form another pair of adjacent tubes where the third tube 250c is the inner tube and the second tube 250b is the outer tube, and so forth. The first tube 250a, the second tube 250b, the third tube 250c and the fourth tube 250d are made of a material, e.g., a medical grade metallic material (e.g., stainless steel, cobalt, titanium, copper, etc.) or a medical grade polymeric material (e.g., polystyrene, resins, polytetrafluoroethylene (PTFE), etc.).
[96] Each inner tube (e.g., the second tube 250b, the third tube 250c and the fourth tube 250d) of the pairs of the adjacent tubes is telescopically coupled to the respective outer tube (e.g., the first tube 250a, the second tube 250b and the third tube 250c) and configurable to be in a retracted state and an extended state. In an embodiment, each inner tube is slidably coupled with the respective outer tube such that the inner tube is configured to slide in and fit within a longitudinal cavity of the respective outer tube to be in the retracted state. For example, in the retracted state, the fourth tube 250d fits within the longitudinal cavity of the third tube 250c and so forth. Further, the inner tube is configured to extend out of the respective outer tube in a distal direction to be in the extended state. For example, in the extended state, the second tube 250b extends out of the first tube 250a and so forth. According to an embodiment, each inner tube (e.g., the second tube 250b, the third tube 250c, the fourth tube 250d) includes a first annular ring (not shown) provided on an outer surface at a respective proximal end and each outer tube (e.g., the first tube 250a, the second tube 250b and the third tube 250c) includes an annular protrusion (not shown) on an inner surface at a respective distal end. In the extended, the first annular ring of each inner tube (e.g., the second tube 250b, the third tube 250c, the fourth tube 250d) mates with the annular protrusions of the respective outer tube (e.g., the first tube 250a, the second tube 250b and the third tube 250c), preventing the slippage of the inner tube from the respective outer tube. The outer diameter of the first annular ring is larger than the inner diameter of the respective annular protrusion. Further, each inner tube includes a second annular ring (not shown) provided on the outer surface at a distal end. In the retracted state, the second annular ring of each inner tube (e.g., the second tube 250b, the third tube 250c, the fourth tube 250d) is disposed out of the respective outer tube (e.g., the first tube 250a, the second tube 250b and the third tube 250c) and mates with a distal face of the respective outer tube. The outer diameter of the second annular ring of the inner tube is larger than an inner diameter of the respective outer tube, thereby preventing the inner tube from being retracted completely into the respective outer tube.
[97] Further, a distal end of the innermost tube (the fourth tube 250d in the depicted embodiment) is coupled to the proximal end 200a of the needle 200 using any suitable coupling technique. In an embodiment, the needle 200 is integrally coupled (i.e., forms an integrated structure) with the innermost tube (e.g., the fourth tube 250d). In response to any one of the inner tubes of the telescopic assembly being moved to the retracted state, the needle 200 is configured to be retracted in the proximal direction, causing a corresponding one of the two or more electrode assemblies to be exposed. Similarly, in response to any one of the inner tubes of the telescopic assembly being moved to the extended state, the needle 200 is configured to move in distal direction, causing the corresponding one of the two or more electrode assemblies to be covered.
[98] The retraction and extension of the telescopic assembly is controlled by the roller 260. In an embodiment, the innermost tube (e.g., the fourth tube 250d) of the telescopic assembly is coupled to the roller 260. The roller 260 is capable of being rotated in one of a first pre-defined direction (e.g., a clockwise direction) or a second pre-defined direction (e.g., an anticlockwise direction), and enables the user to control the extension and retraction of the telescopic assembly, thereby controlling the deployment of the two or more electrode assemblies. One embodiment of the working of the telescoping assembly and the roller 260 is explained below with reference to Figs. 4a1-4a2, 4b1-4b2, 4c1-4c2 and 4d1-4d2. The following description is merely exemplary and should not be considered as limiting. A person skilled in the art will appreciate that the teaching of the present disclosure can be applied to any number of electrode assemblies and a telescopic assembly having a desired number of tubes, and the same is within the scope of the present disclosure.
[99] In an embodiment, the roller 260 includes a knob 260a and a spindle 260b that extends from the knob 260a, as shown in Figs. 4a1-4a2. The knob 260a is rotatable in the first pre-defined direction and the second pre-defined direction. The knob 260a includes a peripheral surface that may be textured or contoured to provide a better grip to the user. The spindle 260b may be smooth, threaded or semi-threaded. In an embodiment, the spindle 260b is threaded. The roller 260 is provided in the distal portion 300b of the handle 300. The distal portion 300b of the handle 300 includes a hole (not shown) through which the spindle 260b is inserted into the handle 300. A first end of a wire 262 is coupled to the spindle 260b and a second end of the wire 262 is coupled to a distal end of the innermost tube (e.g., the fourth tube 250d). The wire 262 may be an elastic strip, a metal wire, a spring, etc. In an exemplary embodiment, the wire 262 is a metal wire.
[100] In an embodiment, in response to rotation of the roller 260 in the first pre-defined direction, the wire 262 is configured to wrap around the spindle 260b. And, in response to the rotation of the roller 260 in the second pre-defined direction, the wire 262 is configured to unwrap from the spindle 260b.
[101] In response to each rotation of the roller 260 in the first pre-defined direction, one inner tube of one of the pairs of adjacent tubes (e.g., the fourth tube 250d, the third tube 250c and the second tube 250b) of the telescopic assembly is configured to retract within the corresponding outer tube (e.g., the third tube 250c, the second tube 250b and the first tube 250a), causing the needle 200 to retract in the proximal direction by a pre-defined distance and expose one electrode assembly of the two or more electrode assemblies. Similarly, in response to each rotation of the roller 260 in the second pre-defined direction, one inner tube of the telescoping assembly is configured to extend out of the corresponding outer tube, causing the needle 200 to advance in the distal direction by the pre-defined distance and cover one electrode assembly of the two or more electrode assemblies.
[102] The exposure and/or covering of the two or more electrode assemblies with the help of the roller 260 is now explained. At the time of piercing the patient’s skin and navigating the needle 200 to the target tissue, all inner tubes (viz., the second tube 250b, the third tube 250c and the fourth tube 250d) of the telescopic assembly fully extend out of the respective outer tube (as depicted in Figs. 4a1 – 4a2). Consequently, the needle 200 completely covers the two or more electrode assemblies (as depicted in Fig. 1c).
[103] To expose a distal most electrode assembly (e.g., the first electrode assembly 104a), the roller 260 is rotated in the clockwise direction for one rotation. Tension is induced in the wire 262 due to the rotation of the roller 260, causing the wire 262 to wrap around the spindle 260b. As a result, the fourth tube 250d is pulled in the proximal direction and causes the fourth tube 250d to slide within and move into the third tube 250c of the telescopic assembly (as depicted in Figs. 4b1 – 4b2). This causes the needle 200 to retract by a pre-defined distance (e.g., the length of the fourth tube 250d) in the proximal direction. Consequently, the first electrode assembly 104a is exposed through the tip 200c of the needle 200 at the target site, as shown in Fig. 4e1. To unfurl the first plurality of tines 108a from the stowed state (as shown in Fig. 4e1) to the fully-deployed state (as shown in Fig. 4e2), the first control element 306a is moved from the X position to the Y position, as shown in Fig. 4e2.
[104] To expose intermediate electrode assemblies (e.g., the second electrode assembly 104b), the roller 260 is further rotated in the clockwise direction by one rotation. Additional tension induced in the wire 262 due to the further rotation of the roller 260, causing the wire 262 to further wrap around the spindle 260b. As a result, the third tube 250c is pulled in the proximal direction and causes the third tube 250c to slide within and move into the second tube 250b of the telescopic assembly, as depicted in the Figs. 4c1 - 4c2. This causes the needle 200 to further retract by a pre-defined distance (e.g., the length of the third tube 250c) in the proximal direction. Consequently, the second electrode assembly 140b is exposed through the tip 200c of the needle 200 at the target site, as shown in Fig. 4f1. To unfurl the second plurality of tines 108b from the stowed state (as shown in Fig. 4f1) to the fully-deployed state (as shown in Fig. 4f2), the second control element 306b is moved from the X position to the Y position, as shown in Fig. 4f2.
[105] To expose a proximal-most electrode assembly (e.g., the third electrode assembly 104c), the roller 260 is further rotated in the clockwise direction for another subsequent rotation. An additional tension is induced in the wire 262, causing the wire 262 to further wrap around the spindle 260b. As a result, the second tube 250b is pulled in the proximal direction and causes the second tube 250b to slide into and move within the first tube 250a of the telescopic assembly, as shown in Figs. 4d1 - 4d2. This causes the needle 200 to further retract by a pre-defined distance (e.g., the length of the second tube 250b) in the proximal direction. Consequently, the third electrode assembly 140c is exposed through the tip 200c of the needle 200 at the target site, as shown in Fig. 4g1. To unfurl the third plurality of tines 108c from the stowed state (as shown in Fig. 4g1) to the fully-deployed state (as shown in Fig. 4g2), the third control element 306c is moved from the X position to the Y position, as shown in Fig. 4g2.
[106] Thus, the roller 260 allows the user to expose the electrode assemblies one by one. The control over the exposure of the electrode assemblies in addition to controlling the deployment state of the plurality of tines of an individual electrode assembly, helps the user to control the electrode assemblies (the first electrode assembly 104a, the second electrode assembly 104b, the third electrode assembly 104c) granularly as needed. Therefore, the device 10 can be used for ablating target tissues having a wide range of shapes and sizes. Further, as explained herein, each control element controls the deployment state of all tines of a corresponding electrode assembly simultaneously, instead of separately controlling deployment state of individual tines of the electrode assembly as seen in conventional devices. Consequently, as compared to such a conventional device, the number of control elements provided in the device 10 are significantly lower despite the higher flexibility provided to the user by the device 10. This not only makes the device 10 easier to operate but also to have a simpler design than conventional devices. Further, the reduced number of control elements in the device 10 decreases human errors/fatigue.
[107] To cover the proximal most electrode assembly of the electrode assemblies (e.g., the third electrode assembly 104c), the roller 260 is rotated in the anticlockwise direction for one rotation. Upon rotating the roller 260 in the counterclockwise direction, the wire 262 unwraps from the spindle 260b. This releases tension from the wire 262. As a result, the fourth tube 250d slides out of the third tube 250c of the telescopic assembly in the distal direction. This causes the needle 200 to move in the distal direction. Consequently, the most proximal electrode assembly of the two or more electrode assemblies (the third electrode assembly 104c in the depicted embodiment) is disposed within the lumen 204 of the needle 200 and is covered.
[108] Similarly, to cover the intermediate electrode assemblies of the electrode assemblies (e.g., the third electrode assembly 104b), the roller 260 is further rotated in the anticlockwise direction. For each rotation of the roller 260, an intermediate electrode assembly is covered. The subsequent rotations of the roller 260 in the counterclockwise direction, the wire 262 further unwraps from the spindle 260b. This, further releases tension from the wire 262, causing the third tube 250c to slide out of the second tube 250b, and finally the second tube 250b sliding out of the first tube 250a of the telescopic assembly, causing all electrode assemblies to be covered by the needle 200.
[109] Referring now to Figs. 5a and 5b, the device 10 includes a three-port coupling element 314 configured to supply a fluid into the targeted tissue. In an embodiment, the fluid is a saline solution. In an embodiment, the three-port coupling element 314 is disposed within the central portion 300c of the handle 300.
[110] In an embodiment, the three-port coupling element 314 includes a first port 316, a second port 318 and a third port 320. The first port 316 is configured to receive the fluid. For example, the first port 316 is configured to be coupled to an external instrument (e.g., a syringe) providing the fluid.
[111] The second port 318 is coupled to the outermost tube (e.g., to the first tube 250a) of the telescopic assembly with the help of a first connector 318a. In an embodiment, a proximal portion of the outermost tube (e.g., the first tube 250a) is disposed within and coupled with the second port 318. An outer diameter of the outermost tube corresponds to an inner diameter of the second port 318. The first tube 250a may be coupled to the second port 318 using techniques, such as, without limitation, threaded coupling, gear coupling, etc. In an embodiment, the first tube 250a is coupled to the second port 318 using a threaded coupling. In an embodiment, the second port 318 includes external threads. The external threads of the second port 318 are configured to mate with internal threads provided within the first connector 318a. Once the internal threads of the first connector 318a engage with the external threads of the second port 318, the first connector 318a may be rotated to tighten the coupling between the second port 318 and the outermost tube (e.g., the first tube 205a) of the telescopic assembly. The tight coupling thus formed, prevents the leakage of the fluid outside of the telescopic assembly. Though in the depicted embodiment, the second port 318 is coupled to the telescopic assembly using the first connector 318a, it should be appreciated that the second port 318 may be coupled to the outermost tube of the telescopic assembly using any other equivalent coupling technique, without deviating the scope of the present disclosure.
[112] The second port 318 facilitates channelization of the fluid received from the first port 316 into the telescopic assembly. In an embodiment, the longitudinal cavity of the outermost tube (e.g., the first tube 250a) of the telescopic assembly is fluidically coupled to the first port 316 such that the fluid flows from the first port 316 to the longitudinal cavity of the outermost tube, then passes through the longitudinal cavities of the remaining tubes of the telescopic assembly into the lumen 204 of the needle 200, and from there to the target site. In an example implementation, the fluid includes a saline solution. The saline solution maintains moisture and conductivity at the target site during the ablation procedure.
[113] The third port 320 is coupled to the proximal portion 300a of the handle 300 using a second connector 320a. In an embodiment, the second connector 320a includes a spindle (not shown) extending from a distal end of the second connector 320a to a proximal end of the second connector 320a. An outer surface of the spindle of the second connector 320a includes external threads. The third port 320 includes internal threads provided on an inner surface. To couple the third port 320 with the second connector 320a, the spindle of the second connector 320a is disposed within the second port 320 and the external threads on the spindle of the second connector 320 are engaged with the internal threads of the third port 320.
[114] The third port 320 includes a rubber bush 322 disposed within a lumen of the third port. In response to the rotation of the second connector 320a, the external threads on the spindle of the second connector 320a mates with the internal threads of the third port 320 and the rubber bush 322 is compressed. Thus, the rubber bush 322 prevents backflow of the fluid towards the proximal portion 300a of the handle 300.
[115] Fig. 6 depicts a flowchart 1000 of a method of operating the device 10, according to an embodiment of the present disclosure.
[116] At step 1002, the user pierces a portion of the skin of an individual with the help of the tip 200c of the needle 200 and the needle 200 is advanced towards a target tissue 600 (as shown in Fig. 7).
[117] Once the tip 200c of the needle 200 approaches the target tissue 600, the user rotates the roller 260 in the clockwise direction, at step 1004. This causes retraction of the needle 200 within the handle 300. Upon a first rotation of the roller 260, the distal tip 102c of the rod 102 is exposed along with the first electrode assembly 104a. As explained earlier, each rotation of the roller 260 results in exposure of one electrode assembly of the two or more electrode assemblies. The user rotates the roller 260 a desired number of times to expose the desired number of electrode assembly/assemblies based upon, say, the size and shape of the target tissue 600. In an embodiment, the user rotates the roller 260 three times to expose all three electrode assemblies 104a – 104c.
[118] At step 1006, the target tissue 600 is pierced using the distal tip 102c of the rod 102 and the exposed electrode assemblies are disposed within the target tissue 600.
[119] At step 1008, a desired plurality of tines (the first plurality of tines 108a, the second plurality of tines 108b and the third plurality of tines 108c) of the respective electrode assemblies (the first electrode assembly 104a, the second electrode assembly 104b and the third electrode assembly 104) are deployed using the two or more control elements. For example, the user slides one or more of the control elements (the first control element 306a, the second control element 306b and the third control element 306c) within the corresponding slot between the distal position X and the proximal position Y (or a position therebetween) to control the deployment state of the plurality of tines of the corresponding electrode assembly. In the depicted embodiment, the user slides the first control element 306a, the second control element 306b and the third control element 306c to the proximal position Y, thereby fully deploying the first plurality of tines 108a, the second plurality of tines 108b and the third plurality of tines 108c, respectively (depicted in Fig. 7) as explained earlier.
[120] At step 1010, an excitation source is activated and an excitation signal (e.g., RF or MW excitation signal) is provided to the first control wire 114a, the second control wire 114b and the third control wire 114c. In an embodiment, each control wire (114a, 114b, 144c) is coupled to the excitation source. The excitation source is configured to generate the excitation signal. The first control wire 114a, the second control wire 114b and the third control wire 114c transfers the excitation signal to the first plurality of tines 108a, the second plurality of tines 108b and the third plurality of tines 108c, respectively. This induces thermal changes within the target tissue 600 and leads to ablation of the target site in the form of, such as, necrosis, coagulation or modification.
[121] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. ,CLAIMS:WE CLAIM:
1. A device (10) for ablating tissues, the device (10) comprising:
i. a rod (102);
ii. two or more electrode assemblies provided on a distal portion of the rod (102), each electrode assembly (104a, 104b, 104c) includes:
a. a plurality of tines (108a, 108b, 108c) having a proximal end and a distal end, the proximal ends of the plurality of tines (108a, 108b, 108c) coupled to the rod (102), and
b. a control ring (110a, 110b, 110c) slidably disposed over the plurality of tines (108a, 108b,108c) between a first position and a second position; and
iii. two or more control elements, each control element (306a, 306b, 306c) is coupled to a respective control ring (110a, 110b, 110c);
wherein, in response to a first trigger received by one of the control elements (306a, 306b, 306c), the respective control ring (110a, 110b, 110c) is configured slide proximally towards the second position over the plurality of tines (108a, 108b, 108c) of a corresponding electrode assembly, causing the plurality of tines (108a, 108b, 108c) to unfurl.
2. The device (10) as claimed in claim 1, wherein each electrode assembly (104a, 104b, 104c) is configured to move between a stowed state and a fully-deployed state, wherein;
a. in the stowed state, the control ring (110a, 110b, 110c) is disposed at the distal end of the plurality of tines (108a, 108b, 108c), causing the plurality of tines (108a, 108b, 108c) to collapse and longitudinally align with the rod (102);
b. in the fully deployed state, the control ring (110a, 110b, 110c) is disposed at the proximal end of the plurality of tines (108a, 108b, 108c); causing the plurality of tines to unfurl.
3. The device (10) as claimed in claim 2, wherein each electrode assembly (104a, 104b, 104c) is configured to move to at least one partially deployed state, wherein in the at least one partially deployed state, the control ring (110a, 110b, 110c) is disposed at a third position between the proximal end and the distal end of the plurality of tines (108a, 108b, 108c), causing the plurality of tines (108a, 108b, 108c) to partially unfurl.
4. The device (10) as claimed in claim 1, wherein each electrode assembly (104a, 104b, 104c) includes an inner ring coupled to the rod (102), wherein the proximal end of the plurality of tines (108a, 108b, 108c) of the electrode assembly (104a, 104b, 104c) are coupled to the inner ring.
5. The device (10) as claimed in claim 4, wherein each electrode assembly (104a, 104b, 104c) includes a band (106a, 106b, 106c) fixedly coupled to the inner ring; wherein the proximal end of the corresponding plurality of tines (108a, 108b, 108c) are coupled to an outer surface of the inner ring and are disposed between an inner surface of the band (106a, 106b, 106c) and the outer surface of the inner ring.
6. The device (10) as claimed in claim 5, wherein at least one radiopaque marker is coupled to an outer surface of each band (106a, 106b, 106c).
7. The device (10) as claimed in claim 1, wherein each control ring (110a, 110b, 110c) is coupled to the corresponding control element (306a, 306b, 306c) via a respective control wire (114a, 144b, 114c) and in response to the trigger received by the one of the control elements (306a, 306b, 306b) in one of a proximal direction or a distal direction, the respective control wire (114a, 144b, 114c) is configured to move the corresponding control ring (110a, 110b, 110c) over the plurality of tines (108a, 108b, 108c) of a corresponding electrode assembly (104a, 104b, 104c) in a proximal direction or a distal direction, causing the plurality of tines to unfurl or collapse, respectively.
8. The device (10) as claimed in claim 7, wherein each control ring (110a, 110b, 110c) includes a spiral groove (A1) configured to receive the respective control wire (114a, 114b, 144c).
9. The device (10) as claimed in claim 7, wherein each electrode assembly (104a, 104b, 104c) includes a support ring (109a, 109b, 109c) comprising a hole configured to provide a passage to a respective control wire (114a, 114b, 114c).
10. The device (10) as claimed in claim 7, wherein each control wire (114a, 114b, 114c) is coupled to an excitation source configured to generate an excitation signal, wherein each control wire (114a, 114b, 114c) is configured to transfer the excitation signal received from the excitation source to the plurality of tines (108a, 108b, 108c) of the respective electrode assembly (104a, 104b, 104c).
11. The device (10) as claimed in claim 1, wherein the device (10) includes a needle (200) comprising a lumen (204) configured to receive the rod (102).
12. The device (10) as claimed in claim 11, wherein one or more radiopaque markers are coupled to an outer surface of the needle (200).
13. The device (10) as claimed in claim 1, wherein the device (10) comprises:
a. a telescopic assembly comprising an outermost tube (250a) provided at a proximal end of the telescopic assembly, an innermost tube (250d) provided at a distal end of the telescopic assembly, and one or more intermediate tubes (250b, 250c), forming two or more pairs of adjacent tubes telescopically coupled to each other, an inner tube (250b, 250c, 250d) of each pair of adjacent tubes is slidably coupled with a respective outer tube (250a, 250b, 250c) of the pair of adjacent tubes;
b. a roller (260) coupled to the innermost tube (250d) of the telescopic assembly and being rotatable in a first pre-defined direction and a second pre-defined direction,
wherein in response to the roller (260) rotating by one rotational cycle in the first pre-defined direction, the inner tube (250b, 250c, 250d) of one of the pairs of adjacent tubes is configured to slide within the respective outer tube (250a, 250b, 250c), causing the needle (200) to retract in a proximal direction, exposing a corresponding electrode assembly (104a, 104b, 104c) of the two or more electrode assemblies (104a, 104b, 104c), and
wherein in response to the roller (260) rotating by one rotational cycle in second first pre-defined direction, the inner tube (250b, 250c, 250d) of one of the pairs of adjacent tubes is configured to slide out of the respective outer tube (250a, 250b, 250c), causing the needle (200) to advance in a distal direction, covering the corresponding electrode assembly (104a, 104b, 104c) of the two or more electrode assemblies (104a, 104b, 104c).
14. The device (10) as claimed in claim 13, wherein the device (10) includes a handle (300) comprising:
a. a proximal portion (300a) configured to receive the two or more control elements (306a, 306b, 306c);
b. a distal portion (300b) configured to receive the telescopic assembly and the roller (260); and
c. a central portion (300c) provided between the proximal portion (300a) and the distal portion (300b), the central portion (300c) comprising a three-port coupling element (314) comprising:
i. a first port (316) configured to receive a fluid;
ii. a second port (318) coupled to the outermost tube (250a) of the telescopic assembly using a first connector (318a), the second port (318) configured to transport the fluid from the first port (316) to the needle (200); and
iii. a third port (320) coupled to the proximal portion (310) of the handle (300) using a second connector (320a), the third port (320) including a bush (322) configured to prevent the flow of the fluid into the proximal portion (310) of handle (300).
15. The device (10) as claimed in claim 1, wherein an insulating coating is provided on at least a partial length of the rod (102).
16. The device (10) as claimed in claim 1, wherein the two or more electrode assemblies (104a, 104b, 104c) include equal number of tines (108a, 108b, 108c).
17. The device (10) as claimed in claim 1, wherein the two or more electrode assemblies (104a, 104b, 104c) include different number of tines (108a, 108b, 108c).
18. The device (10) as claimed in claim 1, wherein the rod (102) includes a thermocouple sensor.
19. The device (10) as claimed in claim 1, wherein each control element (306a, 306b, 306c) is disposed in a respective slot (312a, 312b, 312c) provided in a handle (300), each control element (306a, 306b, 306c) is configured to move within the respective slot (312a, 312b, 312c) between an X position and a Y position.