A device for intravascular imaging and blockage

Abstract

The present invention relates to a gripper device with a holding structure (10) capable of varying its grip from relaxed to light and form gripping positions, the device offers adaptability to different levels of environmental materials encountered within blood vessels This feature enables controlled manipulation and secure engagement with tissues or other materials, enhancing procedural safety and effectiveness. Furthermore, the gripper device incorporates an aspiration tube (15) that operates in conjunction with the holding structure (10) during lighter gripping conditions, facilitating the removal of materials from the vessel environment as necessary. The device is equipped with an imaging module (50), such as an intravascular ultrasound probe (70), which provides real-time data and imaging feedback to guide and monitor procedures accurately.

Description

[0001] A DEVICE FOR INTRAVASCULAR IMAGING AND BLOCKAGE

[0002] REMOVAL

[0003] FIELD OF INVENTION

[0004]

[0001] The present invention relates to a gripper device for use in intravascular operational procedures. The invention specifically pertains to devices designed to facilitate precise manipulation and controlled interaction with environmental materials within blood vessels. In addition, the invention pertains to the gripper device which integrates adjustable gripping capabilities with real-time imaging technology to enhance procedural accuracy and efficacy during intravascular interventions.

[0005] BACKGROUND OF THE INVENTION

[0006]

[0002] The background description includes a basic of the field of invention including a study of recent technologies along with a few patent literatures that may be useful in understanding the present invention. Intravascular procedures often necessitate the use of specialized tools capable of navigating and performing tasks within the intricate confines of blood vessels. Conventional devices typically lack the versatility to adapt their gripping force dynamically to varying conditions encountered within the vessel. This limitation can impact procedural success, patient safety, and overall efficacy of treatments.

[0007]

[0003] Existing gripper devices and tools for intravascular interventions may focus on either static gripping mechanisms or limited imaging capabilities. Such devices may struggle to provide real-time feedback or adjust their grip strength according to the changing nature of the vessel environment, which can include delicate tissues, plaques, or other obstructions.

[0008]

[0004] There exists a technical problem in the field of intravascular procedures concerning the need for a gripper device that combines adjustable gripping capabilities with advanced imaging technology. The ideal device should enable medical practitioners to perform procedures with enhanced precision, adaptability, and real-time environmental monitoring within blood vessels. Addressing this problem is crucial to improving procedural outcomes, reducing risks associated with intravascular interventions, and optimizing patient care.

[0009]

[0005] Therefore there requires a proposed gripper device that innovatively addresses the aforementioned challenges. By integrating a holding structure capable of varying its grip from relaxed to light and form gripping positions, the device offers adaptability to different levels of environmental materials encountered within blood vessels. This feature enables controlled manipulation and secure engagement with tissues or other materials, enhancing procedural safety and effectiveness. In this instant, a few patent literatures have discussed herein.

[0010]

[0006] The patent literature holding the Patent Publication No. WO2011162815A1 has been described in brief having titled Multiple Function Vascular Device The cited prior art disclosed A multi-purpose vascular device defines a lumen that allows fluid communication there through and has a coil with a side of coil winds having solid physical connections between the coil winds to prevent the connected coil wind side from expanding following the application of force by an actuating member which causes the connected coil winds to have a predetermined configuration in an unstressed state. The application of longitudinal force causes the unconnected coil winds to expand, resulting in the vascular device assuming a different configuration. Further, in the cited art, there was no discussion about the detailed imaging facilitates an assessment of the blockage's composition, size, and location. The system offers switching of different types of grippers. So it does not match the essential features mentioned in the present invention. Hence, the cited prior art is different from the present invention, because it does not disclose the essential features as claimed in the present invention. Further, the next cited patent literature is described hereinbelow.

[0011]

[0007] The second Patent literature holding the Application No. US201715604531A has described in brief having titled “Axial lengthening thrombus capture system”. The cited patent literature described Systems and methods that can remove material of interest, including blood clots, from a body region, including but not limited to the circulatory system for the treatment of pulmonary embolism (PE), deep vein thrombosis (DVT), cerebrovascular embolism, and other vascular occlusions. The invention also mentions about Intravascular Ultrasound (IVUS) transducer. The guide catheter which is inserted coaxially facilitates the removal of a blockage within the vasculature of a patient.Ultrasound imaging for identifying the presence and characteristics of any blockages. Gripper is used as a capturing portion for obstruction. ALTC device helps in the removal of calcification formed and with the help of aspiration technique for removal of clots / thrombus. Guide catheter is used for blockage removal. The invention does not explain about the following: The detailed imaging facilitates an assessment of the blockage's composition, size, and location; Deciding the type of gripper to be used; switching of different types of grippers. The catheter being pulled out of the blood vessel.

[0012]

[0008] The Third US Patent literature holding the Application No. US201816103802A has described in brief having titled “ Phased Array Imaging and Therapy Intraluminal Ultrasound Device”. The cited patent literature described Intraluminal ultrasound devices, systems and methods are provided. In one embodiment, an intravascular ultrasound device includes a flexible elongate member configured to be positioned within the body lumen of a patient, the flexible elongate member includes a distal portion and a longitudinal axis; a first ultrasound transducer array configured to obtain ultrasound imaging data of the body lumen; and a second ultrasound transducer array configured to apply an ultrasound therapy within the body lumen. Both the first and second ultrasound transducer arrays are disposed at the distal portion of the flexible elongate member and circumferentially positioned around the longitudinal axis of the flexible elongate member. Also, the invention mentions about intraluminal ultrasound device used for imaging and therapy for the removal of blockage in the vessel. The guide catheter is positioned within the lumen of the anatomy. Ultrasound imaging for identifying the presence and characteristics of any blockages. The detailed imaging facilitates an assessment of the blockage's composition, size, and location. The medical practitioner makes decisions regarding the type of treatment instruments to be used based on the identified characteristics of the blockage. The treatment instrument is decided based on occlusion such as calcium deposit. An aspiration device is used for thrombus / blockage removal. The catheter along with guidewire is used. The invention does not explain directly about the medical practitioner makes decisions regarding the type of gripper used and switching between the grippers but explains about the calcium and thrombus blockage removal using the aspiration technique. The catheter is being pulled out of the blood vessel.

[0013] OBJECTS OF THE INVENTION

[0014]

[0009] The object of the invention is to provide a gripper device with a holding structure capable of varying its gripping positions to adapt to different levels of environmental materials encountered within blood vessels.

[0015] To create a comprehensive intravascular gripper device that combines gripping, aspiration, imaging, and force-sensing capabilities for improved operational precision and effectiveness.

[0016] [Oi l] Said and other objects of the present disclosure will be apparent to a person skilled in the art after consideration of the following summary of the subject matter as claimed, a detailed description taken into consideration with accompanying drawings in which preferred embodiments of the present disclosure are illustrated.

[0017] SUMMARY OF INVENTION

[0018]

[0012] The object of the invention is achieved using a gripper device for intravascular operational procedures. The gripper device includes a holding structure adapted to be in a relaxed position, a light gripping position, and a form gripping position by varying contraction onto environmental material present in the blood vessel. The device also includes an aspiration tube adapted to work along with the holding structure when the holding structure is in the lighter gripping position. This configuration allows for precise control during procedures, enabling safe navigation through blood vessels and effective material removal, thus enhancing procedural efficacy and safety.

[0019]

[0013] In another embodiment of the invention, the gripper device of the present invention has the holding structure placed concentrically to itself. The concentric placement ensures uniform force distribution and a compact design, facilitating easier navigation through blood vessels while maintaining effective gripping capabilities.

[0020]

[0014] In yet another embodiment of the present invention, the gripper device of the present invention has a holding structure with a curved structure, wherein the curved structure is contracted to be in the light gripping position and expanded to be in the form gripping position. The curved structure provides better conformity to vessel walls, potentially reducing trauma and improving the ability to trap and manipulate materials within the blood vessel.

[0021]

[0015] In another embodiment of the present invention, the gripper device of the present invention has a holding structure comprising a plurality of joints or hinges. Multiple joints or hinges increase flexibility and maneuverability, allowing the device to navigate complex vascular structures more effectively and adapt to varying vessel diameters.

[0022]

[0016] In another embodiment of the present invention, the gripper device of the present invention comprises an imaging module and a display unit, wherein the imaging module is adapted to capture data of the environment of the blood vessel in real-time and to generate images of the environment of the blood vessel in realtime, and the display unit is adapted to display the images in real-time. Real-time imaging and display capabilities enhance visibility during procedures, leading to improved decision-making and procedural precision.

[0023]

[0017] In another embodiment, the gripper device of the present invention has an imaging module comprising an intravascular ultrasound probe that moves along the holding structure inside the blood vessel and captures data from the environment of the blood vessel. The movable ultrasound probe allows for comprehensive data capture along the length of the holding structure, providing detailed information about the vessel environment and potential obstructions.

[0024]

[0018] Another embodiment of the gripper device of the present invention comprises a controlling module adapted to receive a form control signal to optimize the holding structure to be in the form gripping position or a lighter signal to optimize the holding structure to be in the light gripping position and to activate the aspiration tube. This automated control system optimizes the gripping position and aspiration, potentially improving procedural efficiency and reducing operator fatigue.

[0025]

[0019] Another embodiment of the gripper device of the present invention comprises a processing module adapted to receive and process images of the environment of the blood vessel and to generate the form signal or the lighter signal. The processing module enables data-driven decision-making, potentially improving the accuracy and safety of the procedure by automatically adjusting the device based on realtime imaging data.

[0026]

[0020] In an another embodiment of the gripper device of the present invention comprises a control switch coupled to the controlling module and adapted to send the form signal or the lighter signal to the controlling module. The manual control switch provides a backup option for direct operator control, enhancing the device's versatility and allowing for immediate response to unforeseen circumstances.

[0027]

[0021] Another embodiment of the gripper device of the present invention comprises force sensors coupled to the holding structure and / or the aspiration tube for sensing a force applied by the environmental material onto the holding structure and / or the aspiration tube to generate a haptic parameter (20), wherein the controlling module is coupled to the one or more force sensors to receive and process the haptic parameters and to optimize grip of the holding structure onto the environmental material and / or to optimize suction flow of the aspiration tube. Force sensing capabilities allow for precise control of gripping force and suction, potentially reducing the risk of vessel damage while ensuring effective material manipulation and removal.

[0028]

[0022] The concepts are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.

[0029]

[0023] To further understand the characteristics and technical contents along with technical advantages and exemplary data of the present disclosure, a description relating thereto will be made with reference to the accompanying drawings. However, the drawings are illustrative only and not used to limit the scope of the present subject matter. BRIEF DESCRIPTION OF DRAWINGS

[0030]

[0024] It is to be noted, however, that the appended drawings illustrate only typical embodiments of the present subject matter and are therefore not to be considered for limiting its scope, for the invention may admit to other equally effective embodiments. The detailed description is described with reference to the accompanying figures. In the figures, a reference number identifies the figure in the reference number first appears. The same numbers are used throughout the figures to reference features and components. Some embodiments of system method or structure in accordance with embodiments of the present subject matter are now described, by way of example, and with reference to the accompanying figures, in which:

[0031]

[0025] Figure 1 : Illustrates a gripper device which is a flexible imaging probe with blockage removal.

[0032] Figure 2: Illustrates the cross-sectional view of the distal end of the gripping device. Figure 3: Illustrates the front view of the distal end of an embodiment of the gripping device with no joints.

[0033] Figures 3A, 3B and 3C: Illustrate a relaxed, light gripper and form gripper view of the gripper device with no joints.

[0034] Figure 4: Illustrates the front view of the distal end of the apparatus with two joints where the gripper is in the relaxed state, according to the embodiment.

[0035] Figure 4 A and 4B: Light gripper view and form gripper view with two joints, according to an embodiment.

[0036] Figure 5: Illustrates the front view of the distal end of the apparatus with three joints where the gripper is in the relaxed state, according to the embodiment.

[0037] Figure 5 A and 5B: Light gripper view and form gripper view with three joints, according to an embodiment.

[0038] Figure 6: Illustrates a step-by-step process detailing how the Intravascular Ultrasound (IVUS)-guided blockage removal system.

[0039] Figure 7 : Illustrates the gripper device with the data flow between the structural elements in the device.

[0040]

[0026] The figures depict embodiments of the present subject matter for the purposes of illustration only. A person skilled in the art will easily recognize from the following description that alternative embodiments of the device and process illustrated herein may be employed without departing from the principles of the disclosure described herein.

[0041] DETAILED DESCRIPTION

[0042]

[0027] The best and other modes for carrying out the present invention are presented in terms of the embodiments, herein depicted in the drawings provided. The embodiments are described herein for illustrative purposes and are subject to many variations. It is understood that various omissions and substitutions of equivalents are contemplated as circumstances may suggest or render expedient, but are intended to cover the application or implementation without departing from the spirit or scope of the present invention. Further, it is to be understood that the phraseology and terminology employed herein are for the purpose of the description and should not be regarded as limiting. Any heading utilized within this description is for convenience only and has no legal or limiting effect.

[0043]

[0028] The terms “a” and “an” herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced items.

[0044]

[0029] The terms "comprises", "comprising", or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process or method that comprises a list of steps does not include only those steps but may include other steps not expressly listed or inherent to such a process or method. Similarly, one or more sub-systems or elements or structures or components preceded by "comprises... a" does not, without more constraints, preclude the existence of other, sub-systems, elements, structures, components, additional sub-systems, additional elements, additional structures or additional components. Appearances of the phrase "in an embodiment", "in another embodiment" and similar language throughout this specification may, but not necessarily do, all refer to the same embodiment.

[0045]

[0030] For the purpose of promoting an understanding of the principles of the invention, reference will now be made to the embodiment illustrated in the figures and specific language will be used to describe them. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Such alterations and further modifications in the illustrated system, and such further applications of the principles of the invention as would normally occur to those skilled in the art are to be construed as being within the scope of the present invention.

[0046]

[0031] It will be understood by those skilled in the art that the foregoing general description and the following detailed description are exemplary and explanatory of the invention and are not intended to be restrictive thereof.

[0047]

[0032] Unless otherwise defined, all technical and scientific terms used herein have the same meanings as commonly understood by those skilled in the art to which this invention belongs.

[0048]

[0033] The system, method and examples provided herein are only illustrative and not intended to be limiting.

[0049]

[0034] Embodiments of the present invention will be described below in detail with reference to the accompanying figures.

[0050]

[0035] The invention describes a gripper device designed for intravascular procedures, featuring a specialized holding structure with multiple operational states:

[0051] 1. Relaxed Position: In this state, the holding structure (10) exerts no contraction force on the surrounding environmental materials within the blood vessel.

[0052] 2. Light Gripping Position: Here, the holding structure (10) applies a mild level of contraction to the environmental materials present in the vessel.

[0053] 3. Firm Gripping Position: In this state, the holding structure (10) exerts a more substantial contraction force on the environmental materials, significantly greater than that applied in the light gripping position.

[0054] The device's functionality is enhanced by an integrated aspiration tube(15), which is designed to operate in conjunction with the holding structure (10) when it is in the light gripping position. This combination allows for precise manipulation and potential removal of materials within the blood vessel.

[0036] The variable contraction capabilities of the holding structure (10) enable the device to interact with intravascular materials at different intensities, providing medical professionals with a range of options for grasping, manipulating, or extracting materials during procedures. This adaptability makes the device suitable for various intravascular operations, potentially improving precision and efficacy in minimally invasive vascular interventions. The detailed explanation of the subject invention is depicted in FIGS.l to 6 and described hereinbelow.

[0055]

[0037] Figure 1 illustrates flush port (1) in a catheter, which serves as an entry point for introducing fluids, such as saline solution, preventing blockages and ensuring proper functionality of the catheter. The catheter handle (2) is an indispensable tool for medical professionals to ensure accurate insertion and manipulation during procedures, thereby facilitating optimal patient care. An ideal handle should feature a needle deployment mechanism equipped with an auto-lock ring, a needle stop ring with a lock, a needle depth marker, a switch (100) enabling the selection of a form gripper or light gripper, an aspiration technique, and a manipulative switch for holding the blockage content. The manipulative switch is particularly useful in modifying the shape of the gripper to allow for a relaxed and pulled mechanism of the gripper. Needle deployment with auto-lock ring (3) allows for controlled and secure insertion of the needle during medical procedures, ensuring precise placement and minimizing the risk of accidental needle movement. The auto-lock ring mechanism adds a layer of safety by preventing unintended retraction or dislodgment of the needle. Needle stop ring with lock (4) with lock in a catheter serves to secure and control the depth of needle insertion, preventing overpenetration and ensuring precise positioning during medical procedures. The lock feature adds stability and enhances safety by preventing unintentional movement. A needle depth marker (5) on a catheter is a visual guide or indicator that helps healthcare professionals gauge and control the depth to which the catheter needle should be inserted into the patient's body. It ensures accurate placement and minimizes the risk of complications by providing a reference point for the appropriate needle penetration depth during medical procedures. The guidewire (6) in a catheter is a thin, flexible wire that serves as a navigational tool during catheterization procedures, guiding the catheter through blood vessels to reach a specific target area within the body. The guidewire port (7) in a catheter serves as a pathway for inserting and navigating a guidewire, a thin, flexible wire used to guide the catheter to its intended location within the body, facilitating precise and controlled medical procedures. The connector cable (8) is the part that is present in the proximal end of the catheter that transmits the ultrasound and other relevant output signals from the catheter to the machine for processing and displaying the images on the monitor connected to the computer console. The imaging and blockage removal probe (9) in the catheter is responsible for capturing real-time internal images, providing crucial visual information for medical procedures, such as guiding catheter placement or visualizing blood vessels and for removal of blockages. The external sheath which is called as holding structure (10) of a catheter serves as a protective covering, providing a smooth and lubricated surface for ease of insertion into the body while preventing damage to delicate tissues. Additionally, it facilitates controlled advancement and withdrawal of the catheter during medical procedures.

[0056]

[0038] The gripper device for intravascular operational procedures has a holding structure (10), wherein the holding structure (10) is adapted to be in a relaxed position, a light gripping position and a form gripping position by varying contraction of the holding structure (10) onto environmental material present in the blood vessel, such that in relaxed position contraction is not applied by the holding structure (10) onto the environmental materials, in the light gripping position a lighter level of contraction is applied onto the environmental materials, and in the form gripping position a higher level of contraction is applied onto the environmental materials, the higher level of contraction is higher than the lighter level of contraction. The aspiration tube (15) is adapted to work along with the holding structure (10) when the holding structure (10) is in the lighter gripping position. The holding structure (10) is placed concentrically. The holding structure (10) is having a curved structure, wherein the curved structure is contracted to be in the light gripping position and expanded to be in the form gripping position. The holding structure (10) comprises a plurality of joints or hinges.

[0057]

[0039] Figure 7 explains the gripper device has an imaging module (50) and a display unit (60), wherein the imaging module (50) is adapted to capture data of the environment (40) of the blood vessel in real time, and to generate images (120) of the environment of the blood vessel in real time, and the display unit (60) is adapted to display the images (120) in real time. The imaging module (50) comprises an intravascular ultrasound probe (70) which moves along the holding structure (10) inside the blood vessel, and captures data (40) from the environment of the blood vessel.

[0058]

[0040] The gripper device also has a controlling module (80) adapted to receive a form control signal (30) to optimize the holding structure (10) to be in the form gripping position or a lighter signal (30) to optimize the holding structure (10) to be in the light gripping position and to activate the aspiration tube (15). There is also a processing module (90) adapted to receive and process images (120) of the environment of the blood vessel and to generate the form control signal (30) or the lighter signal (30).

[0059]

[0041] The gripper device has a control switch (100) coupled to the controlling module (80) and adapted to send the form control signal (30) or the lighter signal (30) to the controlling module (80). There are force sensors (110) coupled to the holding structure (10) and / or the aspiration tube (15) for sensing a force applied by the environmental material onto the holding structure (10) and / or the aspiration tube (15) to generate a haptic parameter (20). The controlling module (80) is coupled to one or more force sensors (110) to receive and process the haptic parameters (20) optimize the grip of the holding structure (10) onto the environmental material and / or optimize the suction flow of the aspiration tube (15).

[0060]

[0042] The gripper device comes with various types of claws that are specifically designed to remove blockages from different types of arteries. These claws have different structures such as three-joint, two-joint, and hemispherical structures with no joints, and can be easily attached to the device using a secure lock screw mechanism.

[0061]

[0043] The gripper device features an override switch that enables toggling between automatic and manual modes of operation for holding and removing blockages. In automatic mode, the device analyzes real-time images of the blood vessels, captured by the device’s imaging system. It assesses the blockage and sends signals (30) to the control system, automatically adjusting the gripping mechanism to apply the appropriate level of grip based on its analysis. This functionality ensures precise and effective performance tailored to the specific conditions inside the patient's blood vessels, assisting doctors in optimizing device handling during procedures.

[0062]

[0044] In manual mode, doctors retain the ability to adjust the gripper based on their judgment. This dual-mode operation enhances the device’s flexibility, allowing medical professionals to select the most suitable mode of gripper according to the nature of blockage in the blood vessels.

[0063]

[0045] The gripper's versatility in adapting its form, whether as a form gripper or a light gripper, relies on a mechanism activated through a switching process that can be using a slide switch. When transitioning to the form gripper mode, the gripper adjusts by slightly closing its jaws or retracting less than in the light gripper mode. Conversely, when switching to the light gripper mode, the same gripper contracts more significantly, partially closing its jaws, while also activating the aspiration tube for enhanced functionality.

[0064]

[0046] The switch (100) regulates the grippers' forms through haptic feedback (20). Initially, the transition between gripper types is facilitated by a slide switch. In the form gripper mode, the gripper adjusts its jaw or retracts slightly to hold blockages like calcium deposits securely. Haptic feedback (20) enables the gripper to conform to the shape of the blockage, ensuring a precise and secure grasp. This feedback is facilitated by force sensors that detect the applied force, ensuring a secure grip without causing damage. Conversely, in the light gripper mode, the gripper contracts more significantly, partially closing the jaw or retracting to delicately handle blockages. This reduces the risk of damage, especially when dealing with delicate blockages like thrombus. The activation of the aspiration tube (15) in this mode provides additional suction to secure the blockage. Haptic feedback (20), facilitated by pressure sensors, adjusts the suction level to maintain a secure grip without damaging the blockage. This ensures efficient removal of the blockage without causing breakdown or damage, as any fragments are suctioned and removed by the aspiration tube (15).

[0065]

[0047] The aspiration port (15) is strategically positioned at the center of the gripper, serving its presence in both form and light gripper modes, activated simply by switching (100). When transitioning to the form gripper mode, the aspiration port (15) remains inactive but is still physically present at the center of the gripper. This setup ensures that during form gripper operation, the aspiration port (15) does not interfere with the precise grasping of blockages like calcium deposits, maintaining the reliability of the procedure.

[0066]

[0048] However, upon switching to the light gripper mode, the aspiration port (15) is also activated concurrently. This activation leverages the vacuum principle to provide additional suction, particularly beneficial when handling delicate blockages like thrombus. The suction generated by the aspiration port (15)aids in securely holding the blockage in place, facilitating its removal without causing damage or fragmentation. Thus, the aspiration port (15) seamlessly integrates with the light gripper mode, enhancing its effectiveness in procedure while remaining inactive during form gripper operation to ensure optimal performance. The pressure and force sensors (110) in the IVUS-guided vascular blockage removal system are placed at the distal tip of the catheter, where the grippers are located. These sensors play a crucial role in facilitating haptic feedback (20), which enables the grippers to conform to the shape of the blockage and maintain a secure grip without causing damage.

[0067]

[0049] In the form gripper mode, force sensors (110) detect the applied force, ensuring a secure grip on the blockage while conforming to its shape. This feedback (20) is essential for maintaining a precise and secure grasp, which is crucial for the effective removal of the blockage. In the light gripper mode, pressure sensors adjust the suction level to maintain a secure grip without damaging the blockage. The activation of the aspiration tube (15) in this mode provides additional suction, particularly beneficial when handling delicate blockages like thrombus. Haptic feedback (20), facilitated by pressure sensors, ensures efficient removal of the blockage without causing breakdown or damage, as any blockage is suctioned and removed by the aspiration tube (15).

[0068]

[0050] The placement of these sensors at the distal tip of the catheter allows for direct interaction with the blockage, providing real-time feedback to the operator and enabling precise and controlled manipulation of the grippers. This integration of sensors and haptic feedback is a key aspect of the intelligent design of the IVUS- guided vascular blockage removal system, which significantly elevates procedural control and precision in vascular interventions.

[0069]

[0051] The flush port in a catheter serves as an entry point for introducing fluids, such as saline solution, to clear and maintain the catheter's internal lumen, preventing blockages and ensuring proper functionality. The guidewire port in a catheter serves as a pathway for inserting and navigating a guidewire, a thin, flexible wire used to guide the catheter to its intended location within the body, facilitating precise and controlled medical procedures.

[0070]

[0052] Figure 2 illustrates the window (13) in a catheter serves as a transparent opening for passing ultrasound waves, allowing visualization of the internal part of the blood vessels. The ultrasound transducer (14) in a catheter emits and receives high-frequency sound waves to create real-time images of the internal structures, aiding in visualizing blockages, blood flow, guiding catheter placement and facilitating diagnostic procedures within the body. The aspiration port (15) in a catheter facilitates the removal of thrombosis or blockages from blood vessels.

[0071]

[0053] Further, the positioning of an ultrasound transducer (14) for intravascular ultrasound (IVUS) imaging, which will be directed through the window (13) and is used to diagnose and detect blockages in the coronary and peripheral vasculature. The ultrasound transducer (14) is positioned above the aspiration suction tube (15) and at the front or distal part of the catheter. Furthermore, the gripper is positioned along with the aspiration tube (15), which is in the center of the gripper.

[0072]

[0054] Figure 3 illustrates the gripper's functionality with the aspiration technique. Specifically, Figure 3a shows the gripper and aspiration tube (15) setup, while Figure 3a and 3b demonstrate the gripper's functionality. As depicted in Figure, the gripper can be in either a relaxed or a pulled form. The pulled form of the gripper aids in holding or grasping the blockage content, in conjunction with the aspiration technique, to suction the thrombus content in the blood vessels. Further, illustrates the front view of the distal end of the apparatus with three joints, according to the embodiment.

[0055] Figure 3: Illustrates the front view of the distal end of an embodiment of the gripping device with no joints.

[0073]

[0056] Figures 3A, 3B and 3C: Illustrate a relaxed, light gripper and form gripper view of the gripper device with no joints.

[0074]

[0058] Figure 4: Illustrates the front view of the distal end of the apparatus with two joints where the gripper is in the relaxed state, according to the embodiment.

[0075]

[0059] Figure 4A and 4B: Light gripper view and form gripper view with two joints, according to an embodiment.

[0076]

[0060] Figure 5 : Illustrates the front view of the distal end of the apparatus with three joints where the gripper is in the relaxed state, according to the embodiment.

[0077]

[0061] Figure 5 A and 5B: Light gripper view and form gripper view with three joints, according to an embodiment.

[0078]

[0062] Both the form gripper and the light gripper are structurally identical and have a single gripper with dual functionality. Despite their physical resemblance, these grippers serve distinct operational purposes. In particular, the catheter handle is equipped with a switch, enabling easy and seamless alternation between the two. The form gripper is designed to remove solid or calcium deposits from blood vessels, whereas the light gripper is specifically intended to work along with aspiration for blood clot removal. Such a versatile design not only streamlines procedures but also enhances precision in addressing a range of blockage types. Overall, this adaptable design highlights the potential for improved clinical outcomes, and the ability to address multiple challenges in a single workflow. Initially, during imaging procedures with the IVUS catheter, the aspiration tube is integrated into the catheter structure near its distal end. It remains positioned behind the gripper or distal end of the catheter. When the form gripper is employed for removing calcium deposits, the aspiration tube may remain inactive, as for the removal of the calcium deposit the form gripper will only be used for the removal of the hard or calcium blockage in the blood vessels. The aspiration tube will become active only when a light gripper is used or opted for by the clinician for the removal of a thrombus or a softer blockage in the blood vessel.

[0063] Figure 6 explains a step-by-step process detailing how the Intravascular Ultrasound (IVUS)-guided blockage removal system is given. Firstly catheter insertion procedure commences with the insertion of the IVUS-guided blockage removal catheter into the blood vessel through a small incision or puncture, either in the groin or forearm. Next, Ultrasound Imaging is done. As the catheter advances through the blood vessels, an ultrasound probe, equipped with an ultrasound transducer, emits high-frequency sound waves to generate real-time, cross-sectional images of the vessel walls, identifying the presence and characteristics of any blockages. Thirdly, a blockage assessment is done. The detailed imaging facilitates an assessment of the blockage's composition, size, and location, providing crucial information for the subsequent steps in the procedure. Next, decision-making is performed. Based on the identified characteristics of the blockage, the medical practitioner makes decisions regarding the type of gripper to be used for effective removal. Next, the gripper selection is done. The system offers to switch of different types of grippers, such as a "form gripper" for solid or calcium deposits and a "light gripper" along with an aspiration technique for removal of blood clots or thrombosis. The medical practitioner selects the appropriate gripper based on the nature of the blockage. Next, gripper engagement is performed. The selected gripper is maneuvered to engage with the blockage, ensuring a secure grip for subsequent removal. This step ensures precision and accuracy in addressing the blockage. Next, the aspiration technique (for thrombosis along with the light gripper) is done. In cases where the aspiration technique is chosen, a tube extending along the length of the catheter, starting from the center part of the gripper (distal part of the catheter), is employed to suction the blood clot inside the catheter. Next, blockage removal is done. With the gripper securely holding the blockage or utilizing the aspiration technique, the system effectively removes the blockage from the blood vessel. Finally, catheter extraction is done. Following successful blockage removal, the catheter, along with any guide wire used, is carefully pulled out of the blood vessel, completing the process. This step-by-step process demonstrates how the IVUS-guided blockage removal system seamlessly integrates ultrasound imaging, gripper selection and targeted intervention to address and remove blockages within blood vessels with precision and efficiency. TECHNICAL ADVANTAGES:

[0079]

[0064] The main advantage of the present invention is that the proposed gripper device has the below advantages

[0080] Precision: Adjustable gripping capabilities allow precise control over interactions with environmental materials, minimizing risks to delicate vessel structures.

[0081] Adaptability: The device adapts its grip strength dynamically, accommodating varying vessel conditions encountered during procedures. Real-time Imaging: Integration of advanced imaging technology enables continuous monitoring and guidance, enhancing procedural accuracy and safety.

[0082] Versatility: Suitable for a range of intravascular interventions, the device improves procedural outcomes and patient care by combining functionality with real-time feedback mechanisms.

Claims

We claim:

1. A gripper device for intravascular operational procedures comprising:- a holding structure (10), wherein the holding structure (10) is adapted to be in a relaxed position, a light gripping position and a form gripping position by varying contraction of the holding structure (10) onto environmental material present in the blood vessel, such that in relaxed position contraction is not applied by the holding structure (10) onto the environmental materials, in the light gripping position a lighter level of contraction is applied onto the environmental materials, and in the form gripping position a higher level of contraction is applied onto the environmental materials, the higher level of contraction is higher than the lighter level of contraction,- an aspiration tube (15) adapted to work along with the holding structure (10) when the holding structure (10) is in the lighter gripping position.

2. The gripper device as claimed in claim 1, wherein the holding structure (10) is placed concentrically to the holding structure (10).

3. The gripper device as claimed in claim 1, wherein the holding structure (10) is having a curved structure, wherein the curved structure is contracted to be in the light gripping position and expanded to be in the form gripping position.

4. The gripper device as claimed in claim 1, wherein the holding structure (10) comprises a plurality of joints or hinges.

5. The gripper device as claimed in claim 1, wherein the gripper device comprising an imaging module (50) and a display unit (60), wherein the imaging module (50) is adapted to capture data of the environment (40) of the blood vessel in real time,and to generate images (120) of the environment of the blood vessel in real time, and the display unit (60) is adapted to display the images (120) in real time.

6. The gripper device as claimed in claim 4, wherein the imaging module (50) comprises an intravascular ultrasound probe (70) which moves along the holding structure (10) inside the blood vessel, and captures data (40) from the environment of the blood vessel.

7. The gripper device as claimed in claim 5 comprising:- a controlling module (80) adapted to receive a form control signal (30) to optimize the holding structure (10) to be in the form gripping position or a lighter signal (30) to optimize the holding structure (10) to be in the light gripping position and to activate the aspiration tube (15).

8. The gripper device as claimed in claim 7 comprising:- a processing module (90) adapted to receive and process images (120) of the environment of the blood vessel and to generate the form control signal (30) or the lighter signal (30).

9. The gripper device as claimed in claim 7 comprises:- a control switch (100) coupled to the controlling module (80) and adapted to send the form control signal (30) or the lighter signal (30) to the controlling module (80).

10. The gripper device as claimed in claim 8 comprises:- force sensors (110) coupled to the holding structure (10) and / or the aspiration tube (15) for sensing a force applied by the environmental material onto the holding structure (10) and / or the aspiration tube (15) to generate a haptic parameter (20),- wherein the controlling module (80) is coupled to one or more force sensors (110) to receive and process the haptic parameters (20) and to optimize the grip of the holding structure (10) onto the environmental material and / or to optimize the suction flow of the aspiration tube (15).

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