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

1. TITLE OF THE INVENTION:
IMPROVED DEEP BRAIN STIMULATION (DBS) 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
[001] The present invention relates to a medical device. More specifically, the present invention relates to an improved Deep Brain Stimulation (DBS) device.
BACKGROUND OF INVENTION
[002] Neurological disorders are a group of illnesses that affect the central and peripheral nervous systems. The central nervous system consists of the brain and spinal cord, while the peripheral nervous system consists of the nerves that branch out from these areas and into other parts of the body. Such disorders can occur as a result of structural, chemical, or electrical abnormalities within the nervous system. Certain types of neurological disorders include, movement disorders, neuropsychiatric disorders etc.
[003] Neuropsychiatric disorders represent a complex intersection of neurology and psychiatry, encompassing a broad spectrum of conditions that affect both brain function and mental health of a patient. These disorders include conditions like, schizophrenia, bipolar disorder, and major depressive disorders. While, movement disorders are a group of nervous system conditions that affect the movement of a patient, they can cause either increased movements or reduced or slow movements, in the patient. These movements may be under the patient's control, known as voluntary. Or the movements may not be under the patient's control, known as involuntary.
[004] In order to address these disorders (for example, without limitation, neuropsychiatric disorders and movement disorders), deep brain stimulation (DBS) is done. The deep brain stimulation (DBS) is done by implanting a DBS device, through an invasive surgery. The DBS device is used to apply scheduled stimulations (or electrical pulses) to specific cortical and/or subcortical targets of the brain of the patient.
[005] However, the conventional DBS devices possess certain limitations. Conventional DBS devices utilize stimulators that are not readily attachable and/or detachable. In case of adjustment and/or replacement of the stimulator, it requires replacing the whole device. Thus, resulting in a second invasive surgery, accompanied with risks such as, infections, trauma, blood loss and potential damage to the brain. Moreover, in case of replacement, the device is often found to be incompatible with the patient. Thus, requiring various surgical alterations, resulting in complications that may be hazardous to a patient. Also, replacement of the entire device each time, makes the process time consuming and cost ineffective.
[006] Hence, there is a need for a device which can overcome the above limitations.
SUMMARY OF INVENTION
[007] The present invention relates to improved deep brain stimulation (DBS) device including, a proximal end and a distal end. The one or more stimulators is provided towards the distal end of the device. The one or more stimulators contain one or more first magnets. Further, a lead extends from the proximal end to the distal end of the device, having an internal lumen. The internal lumen of the lead contains one or more second magnets. The lead includes one or more cavities towards the distal end of the device, to seat the one or more stimulators. The one or more stimulators are magnetically coupled to the lead via the one or more first magnets and the one or more second magnets, thereby facilitating easy attachment/detachment of the stimulators with the lead and reduced chances of misalignment of the stimulators with the lead.
[008] 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
[009] 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 instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[0010] Fig. 1 depicts a device 100, according to an embodiment of the present invention.
[0011] Figs. 2a-2b depict various perspective views of a stimulator150 of the device 100, according to an embodiment of the present disclosure.
[0012] Fig. 3a depicts a lead 200 of the device 100, according to an embodiment of the present disclosure.
[0013] Figs. 3b-3c depict detailed perspective views of the lead 200 of the device 100, according to an embodiment of the present disclosure.
[0014] Fig. 4 depicts the device 100 in a deployed state, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[0015] 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.
[0016] 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.
[0017] 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.
[0018] Furthermore, the described features, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all embodiments. These features and advantages of the embodiments will become more fully apparent from the following description and apportioned claims, or may be learned by the practice of embodiments as set forth hereinafter.
[0019] In accordance with the present disclosure, an improved deep brain stimulation (DBS) device (hereinafter, referred as a device) is disclosed. The device is implanted at a predefined location (or a target location) in the brain of a patient. The device is used to send one or more electrical impulses to the target location of the brain.
[0020] The device includes a lead and one or more stimulators. The lead and the stimulators are coupled using a secure coupling mechanism. The secure coupling between the stimulators and the lead ensures strong coupling of the two and prevents accidental detachment, while facilitating easy removal when needed for replacement or maintenance. Thus, in case of replacement of one or more stimulators the entire device is not changed. Rather only the faulty stimulator is changed reducing the need for repeated a major surgical intervention and associated risk and complexity of a follow up surgery. This further lowers the cost of maintenance and/or replacement of the device for the patient. Also, the device is versatile as it facilitates patient-specific adaptations in terms of number of stimulators that can be provided with a lead based upon the condition of the patient. For example, if the size of treatment if a target location in the brain is large, more number of stimulators can be included to maintain effective electrical signal strength. This increases the longevity of the device, making it economical for the patient. Further, easy attachment and detachment of the stimulators from the lead of the device, allows the medical practitioners to test more than one stimulator with varying configurations at the target location of the brain, facilitating personalized treatment approaches. Where, varying configurations implies different shapes of the stimulators, different sizes of the stimulators and different intensity of the stimulators.
[0021] The contacts, post coupling of the lead and the stimulator establish a stable electrical connection, allowing precise electrical stimulation to be delivered to the targeted location. This connection further, ensures minimal signal loss and maintains a consistent electrical pathway for effective neuromodulation. In an embodiment, the device uses a magnetic coupling mechanism, which ensures the proper alignment of the stimulator with the lead. This self-alignment property, allows for a quick and reliable connection between the lead and the stimulator of the device, without the need for excessive force, reducing the risk of mechanical damage to the lead and/or surrounding brain tissue.
[0022] Now referring to figures, Fig. 1 depicts a device 100. The device 100 may be configured to be implanted in the brain of a patient. The device 100 is used to stimulate a target location of the brain of the patient. The target location includes without limitation, cortical and/or subcortical targets of the brain of the patient. The device 100 includes a proximal end 100a, a distal end 100b, an anterior side 100c and a posterior side 100d. The device 100 includes one or more stimulators 150 and a lead 200. In an embodiment, there are two stimulators 150 (150a, 150b). The details of the stimulators 150 are explained further with respect to Figs. 2a-2b while, the details of the lead 200 is explained with respect to the Figs. 3a-3c.
[0023] The one or more stimulators 150 may be provided anywhere on the device 100. In an embodiment, the stimulators 150 (150a, 150b) are provided towards the distal end 100b of the device 100. In an embodiment, the stimulators 150 (150a, 150b) are provided on the anterior side 100c of the device 100. The one or more stimulators 150 may be made of a biocompatible material. The biocompatible material may without limitation include, platinum-iridium alloy, titanium, stainless steel, etc., or a combination thereof. In an embodiment, the stimulators 150 are made of gold.
[0024] The stimulators 150 may have a suitable structure, such as without limitation, a cuboidal structure, a circular structure, conical structure, etc. In an embodiment, the stimulators 150 has a cuboidal structure, provided with one or more curved edges. The stimulators 150 include a housing provided with a front wall 150c and a back wall 150d (as shown in Figs. 2a-2b). Each of the front wall 150c and the back wall 150d defines an outer surface and an inner surface, respectively. The stimulators 150 may include without limitation, one or more first contact points 155, one or more second contact points 160, a slot 165 and one or more first magnets. The stimulators 150 are used to provide electrical signals to the target location of the brain of the patient. Further, the stimulators 150 may record one or more electrical parameters meant for determining the electrical activity of the brain. The electrical parameters may without limitation include, local field potentials, action potentials, electroencephalogram (EEG) signals, neural oscillations, etc. The electrical parameters may be used as a real-time feedback, to automatically adjust the stimulations in the brain, via a pulse generator 350 (as explained later). Also, during the surgery, stimulators 150 may be used for brain mapping, for precise placement of the device 100 and maximizing the effectiveness of the device 100.
[0025] The front wall 150c of the stimulators 150, may without limitation include, one or more first contact points 155. In an embodiment, there are two first contact points 155 (155a, 155b) provided on the front wall 150c of each stimulator 150. The first contact points 155 may have a suitable cross-section, such as without limitation, circular, rectangular, oval etc. In an embodiment, the cross-section of the first contact point 155 is circular. The first contact point 155 may be made of platinum-iridium alloy. The one or more first contact points 155 are configured to conduct electrical signals to the target location of the brain. Further, the one or more first contact points 155 are configured to obtain one or more electrical parameters determining the electrical activity of the target location.
[0026] The back wall 150d of the stimulators 150, may without limitation include, one or more second contact points 160 and a slot 165. In an embodiment, there are two second contact points 160 (160a, 160b) provided on each stimulator 150. The second contact points 160 may have a suitable cross-section, such as without limitation, circular, rectangular, oval etc. In an embodiment, the cross-section of the second contact point 160 is circular. The second contact points 160 may be made of a biocompatible conductive material such as, without limitation platinum-iridium alloy, gold, etc. or a combination thereof. In an embodiment, the second contact points 160 are made of platinum-iridium alloy. The one or more second contact points 160 are configured to mate with respective third contact points 210 of the lead 200 (as explained later). The one or more second contact points 160 establish a connection between the lead 200 and the stimulator 150, to conduct electricity.
[0027] In an embodiment, the slot 165 provided on the back wall 150d of each stimulator 150, may have a suitable cross-section such as without limitation, circular, rectangular, square, etc. In an embodiment, the cross-section of the slot 165 is circular. The slot 165 is configured to facilitate detachment of the stimulators 150 from the lead 200 of the device 100 (as explained later). It is to be noted the shape and size of the slot 165 may correspond to the shape and size of one or more openings 215 of the lead 200 (as explained later).
[0028] Further, the one or more first magnets (not shown), are provided at one or more points within the housing of the stimulators 150. More specifically, the one or more magnets are embedded in the inner surface of the back wall 150d, within the housing of the stimulators 150. In an embodiment, there are two first magnets provided with each stimulator 150. The first magnets, may without limitation include, a permanent magnet, a ferromagnetic material, electromagnet, etc. In an embodiment, the first magnet is a neodymium. The first magnet is configured to attract one or more second magnet (as explained later).
[0029] The lead 200 may have a symmetrical or unsymmetrical structure, with for example, curved and/or non-pointed edges, to minimize tissue damage during implantation of the device. Further, the structure of the lead 200 facilitates alteration of the number stimulators 150 coupled to it. For example, depending upon the size of target area to be treated, a medical practitioner can select a device with required number of stimulators 150 coupled to the lead 200, to increase or decrease the intensity of stimulation as per patient's condition. In an embodiment, the lead 200, has a symmetrical tubular structure, defining an internal lumen. The lead 200 extends from the proximal end 100a to the distal end 100b of the device 100. The internal lumen of the lead 200 is configured to house one or more electrical components, to provide electrical signal to the lead 200 from an external source for example, a pulse generator 350 (as explained later). The lead 200 is configured to transmit electrical signals to the target areas within the brain.
[0030] The lead 200 may be made of a biocompatible material such as without limitation, silicone, polyurethane, etc., or a combination thereof. In an embodiment, the lead 200 is made of polyurethane.
[0031] The lead 200 includes one or more cavities 205 (shown in Fig. 3a). In an embodiment, the lead 200 is provided with two cavities 205 (205a, 205b). The one or more cavity205 may be positioned anywhere on the lead 200. In an embodiment, the cavity 205 (205a, 205b) is provided towards the distal end 100b. In an embodiment, the cavity 205 (205a, 205b) is provided on the anterior side 100c of the device 100. The one or more cavity205 may have a suitable cross-section such as, rectangular, rounded, oval, etc. In an embodiment, the one or more cavity 205 has a rectangular cross-section, with one or more curved edges (as shown in Fig. 3b). The cavity 205 is configured to mate with the stimulators 150. It is to be noted that the shape and size of the cavity 205 corresponds to the shape and size of the stimulators 150.
[0032] In an embodiment, each cavity 205 is provided with a base defining an outer surface and an inner surface. The outer surface of the base of the cavity 205, may include without limitation, one or more third contact points 210 and one or more openings 215. In an embodiment, the outer surface of the base of each cavity 205 (205a, 205b) is provided with two third contact points 210 (210a, 210b, 210c, 210d). The third contact points 210 may have a suitable cross-section, such as without limitation, circular, rectangular, hexagonal, etc. In an embodiment, the cross-section of the third contact point 210 is circular. The third contact point 210 may be made of a conductive biocompatible material, such as, platinum-iridium alloy, stainless steel, etc. In an embodiment, the third contact point 210 is made of platinum-iridium alloy. In an embodiment, the third contact point 210 is gold plated. The one or more third contact points 210 are configured to mate with respective second contact points 160 of the stimulator 150.
[0033] In an embodiment, each third contact point 210 includes a resilient member. The resilient member of the third contact point 210 is configured to exert a force perpendicular to the surface of the second contact point 160 of the stimulator 150. Thus, the resilient member ensures consistent and reliable electrical connection between the stimulator 150 and the lead 200, even under conditions where the device 100 is subject to physical motion or disturbances. The resilient member may include without limitation, a spring, an elastomer, etc. In an embodiment, the resilient member is a spring. The spring may be any one of, without limitation, a coil spring, a leaf spring, a torsional spring etc. In an embodiment, the spring is a coil spring.
[0034] In an embodiment, two openings 215 (215a, 215b) are provided on the outer surface of the base of each cavity 205 (205a, 205b) respectively. Each opening 215 extends along the entire thickness of the lead 200. More specifically, the opening 215 extends from the anterior side 100c to the posterior side 100d of the device 100. The opening 215 may have a suitable cross-section such as, without limitation, circular, square, rectangular, etc. In an embodiment, the opening 215 has a circular cross-section. The openings 215 are configured to align with the corresponding slots 165 of the stimulators 150, to facilitate detachment of the stimulators 150 from the lead 200 (as explained later).
[0035] Further, the base of the cavity 205 of the lead 200 is provided with one or more second magnets (not shown). More specifically, the one or more second magnets are provided in the internal lumen of the lead 200, on the inner surface of the base of the cavity 205. It is to be noted, the second magnets are configured to align with the first magnets of the stimulators 150. Hence, the position of the second magnets corresponds to the position of the first magnets, to create a strong magnetic attraction between the two. In an embodiment, two second magnets are provided with each cavity 205. The second magnets, may without limitation include, a permanent magnet, a ferromagnetic material, electromagnet, etc. In an embodiment, the second magnet is a neodymium. The one or more second magnets are configured to attract one or more first magnets of the stimulator 150, ensuring magnetic coupling between the stimulator 150 and the lead 200. The polarity of the first magnet may be opposite to the polarity of the second magnet, to facilitate an attractive force between the two. Further, the position of the first magnet may correspond to the position of the second magnet, ensuring proper alignment and placement of the stimulators 150 into the cavity 205. The magnetic attraction between the first magnets and the second magnets facilitates easy attachment and detachment of the stimulators 150 and the lead 200, allowing a medical practitioner to easily engage and disengage the stimulators 150 without excessive force.
[0036] Now, the coupling of the one or more stimulators 150 with the lead 200 is explained further. In an embodiment, each stimulator 150 (150a, 150b) is placed in the corresponding cavity 205 (205a, 205b). Simultaneously, the second magnet attracts the first magnet, ensuring proper alignment of the stimulator 150 with the cavity 205 of the lead 200. Further, the second contact points 160 of the stimulators 150 mate with the third contact points 210 of the cavity 205. Subsequently, the slot 165 aligns with the corresponding opening 215 of the lead 200.
[0037] Post the coupling, the device 100 is deployed at the target location of the brain of the patient (as shown in Fig. 4). The target location includes without limitation, cortical and/or subcortical targets of the brain of the patient. Thereafter, a pulse generator 350 is surgically implanted in the patient's chest, beneath the skin. The pulse generator 350 is configured to produce precisely controlled electrical signals. The one or more parameters of the electrical signals may be programmed by a medical practitioner, using an external device. The one or more parameters may without limitation include, frequency, amplitude, pulse width, etc. Further, the one or more parameters may be tailored based upon individual patient’s conditions. These electrical signals are configured to be received by the device 100. A cable 300 is used to connect the pulse generator 350 and the device 100. The cable 300 may be made of a conductive biocompatible material, such as silicone-coated copper, platinum-iridium, etc. or a combination thereof. This cable 300 is configured to transmit the electrical signals from the pulse generator 350 to the device 100.
[0038] Further, detachment of the stimulators 150 from the corresponding cavity 205 of the lead 200 is explained. A tool may be used to detach the corresponding stimulator 150 from the cavity 205. The tool may be without limitation, a pin, tweezer, etc. In an embodiment, the tool is a pin. It is to be noted the shape and size of the tool may correspond to the shape and size of the opening 215. The tool is inserted in the opening 215. Thereafter, the tool is used to push the stimulator 150 in the slot 165. The push force acts against the magnetic force, acting between the first magnets and the second magnets of the stimulator 150 and the lead 200 respectively. Thus, resulting in the detachment of the stimulator 150 from the cavity 205 of the lead 200.
[0039] 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. An improved deep brain stimulation (DBS) device (100) comprising:
o a proximal end (100a) and a distal end (100b);
o one or more stimulators (150) provided towards the distal end (100b) of the device (100), the one or more stimulators (150) contain one or more first magnets; and
o a lead (200) extending from the proximal end (100a) to the distal end (100b) of the device (100), having an internal lumen containing one or more second magnets, the lead (200) includes one or more cavities (205) towards the distal end (100b) of the device (100), to seat the one or more stimulators (150);
wherein the one or more stimulators (150) are magnetically coupled to the lead (200) via the one or more first magnets and the one or more second magnets, thereby facilitating easy attachment/detachment of the stimulators (150) with the lead (200) and preventing misalignment of the stimulators (150) with the lead (200).
2. The improved deep brain stimulation (DBS) device (100) as claimed in claim 1 wherein, each stimulator (150) includes one or more first contact points (155) provided on a front wall (150c) of the stimulator (150) to conduct an electrical signal to a target location and obtain one or more electrical parameters determining an electrical activity of a target location.
3. The improved deep brain stimulation (DBS) device (100) as claimed in claim 1 wherein, each stimulator (150) includes one or more second contact points (160) provided on a back wall (150d) of the stimulator (150), to establish a connection between the stimulator (150) and the lead (200).
4. The improved deep brain stimulation (DBS) device (100) as claimed in claim 1 wherein, each stimulator (150) includes a slot (165) provided on a back wall (150d) of the stimulator (150) to facilitate detachment of the stimulator (150) from the lead (200).
5. The improved deep brain stimulation (DBS) device (100) as claimed in claim 1 wherein, each stimulator (150) includes one of a cuboidal structure, provided with one or more curved edges, a circular structure or a conical structure.
6. The improved deep brain stimulation (DBS) device (100) as claimed in claim 1 wherein, each cavity (205) includes a base having one or more third contact points (210) to mate with respective second contact points (160) of the stimulator (150).
7. The improved deep brain stimulation (DBS) device (100) as claimed in claim 6 wherein, the third contact points (210) include a gold plating.
8. The improved deep brain stimulation (DBS) device (100) as claimed in claim 6 wherein, the third contact points (210) include a resilient member.
9. The improved deep brain stimulation (DBS) device (100) as claimed in claim 1 wherein, the lead (200) includes a symmetrical tubular structure, to facilitate alteration of the number stimulators (150) coupled to it.
10. The improved deep brain stimulation (DBS) device (100) as claimed in claim 1 wherein, the lead (200) includes one or more openings (215) aligned with a corresponding slot (165) to facilitate detachment of respective stimulator (150) from the lead (200).