System and method for measuring the force applied to intravascular devices

Abstract

A force meter for detecting forces applied to an intravascular device includes a housing, a passage within the housing configured to receive the intravascular device, and a sensor positioned within the housing to measure the force from the intravascular device to the housing. The force meter may also include electronic components that process force readings from the sensor, transmit the readings to an external receiver, and display the force readings to the user.

Description

Technical Field

[0004] , ,

[0001] Cross - reference to Related Applications and Incorporation by Reference

[0001] The following applications are hereby incorporated by reference in their entirety: U.S. Provisional Patent Application No. 63 / 381,288, filed on October 27, 2022, and U.S. Provisional Patent Application No. 63 / 447,842, filed on February 23, 2023.

Background Art

[0002] Background

[0002] The present disclosure relates to the field of intravascular medical devices. Specifically, the present disclosure relates to systems and methods for measuring the forces applied to intravascular devices intended to traverse a patient's blood vessels to a target region within the patient's body for performing a medical treatment.

[0003]

[0003] Examples of intravascular therapies of the type related to the present disclosure are the use of intravascular devices to treat stenosis, occlusion, or bleeding of blood vessels, including neurovascular, cardiovascular, and peripheral blood vessels. For example, the treatment of an acute stroke caused by an occlusion of a blood vessel in the brain typically involves either the intra - arterial administration of a thrombolytic agent such as recombinant tissue plasminogen activator (rtPA), the mechanical removal of the occlusion, or a combination of the two. These interventional treatments must be performed within hours of the onset of symptoms. Both intra - arterial (IA) thrombolytic therapy and interventional thrombectomy involve accessing the occluded cerebral artery via intravascular techniques and devices. <00000​​

[0004] Mechanical interventions include physical manipulation of the relevant structure to alleviate the cause of the symptoms. For example, mechanical interventions of thrombi include physical removal of thrombi by various means, such as mechanically capturing the thrombus by the use of mesh, balloons, snares, or coils, with or without the addition of assistive techniques such as the use of suction to remove the thrombus or stent to support the vessel. Another example of a mechanical intervention is the mechanical reshaping of a vessel to improve blood flow, which is achieved by using mechanical devices similar to those described above.

[0005]

[0005] After this mechanical procedure is completed, the intravascular device needs to be retracted from the blood vessel. The movement of the intravascular device within the body, especially during retraction, can damage the blood vessel as the device moves, due to the limited space between the intravascular device and the blood vessel wall. This problem is particularly relevant to intravascular devices that have physically captured material (e.g., a thrombus) for removal. In these cases, the capture process usually requires a portion of the intravascular device with a larger cross-section, such as an expanded snare or mesh. This larger cross-section increases friction between the intravascular device and the blood vessel, increasing the risk of damage.

[0006]

[0006] Current techniques to address this situation require training operators of intravascular devices and using imaging techniques to detect undesirable movement of the vessel during the withdrawal process. Training improves this problem to some extent, but it depends on the varying skills of individual operators. Imaging is also helpful, but since movement of the vessel during withdrawal is ideally completely avoided, in practice it is a reactive measure after a problem occurs. Therefore, improved systems and methods are needed to ensure that excessive force is not applied during the withdrawal of intravascular devices. [Overview of the Initiative] [Means for solving the problem]

[0007] Summary of the Invention

[0007] In one embodiment, the force gauge for an intravascular device includes a housing; a hollow tube disposed within the housing and having a bend, extending between two outer sides of the housing and configured to receive an intravascular device; at least one support point disposed within the housing and configured to contact the hollow tube and support the bend; and a sensor disposed within the housing and configured to sense a force applied to the intravascular device.

[0008]

[0008] In another embodiment, a system for measuring the tensile force applied to an intravascular device includes a force gauge according to some embodiments of the present invention and an intravascular device positioned through a hollow tube of the force gauge.

[0009]

[0009] In another embodiment, a method for detecting a tensile force applied to an intravascular device using a force meter includes passing the intravascular device through a force meter of some embodiment of the present invention, detecting a force applied from the intravascular device to a force sensor located in a housing, and processing the force using an electronic component operably connected to the force sensor to determine the tensile force applied to the intravascular device.

[0010]

[0010] Certain aspects of the present disclosure include other steps or elements in addition to or instead of those described above. These steps or elements will become apparent to those skilled in the art by referring to the accompanying drawings and reading the following detailed description.

[0011] Brief explanation of the drawing

[0011] The accompanying drawings incorporated herein and forming part thereof further illustrate the present disclosure, and together with the description, illustrate its principles and enable those skilled in the art to manufacture and use it. [Brief explanation of the drawing]

[0012] [Figure 1]

[0012] This is a perspective view of an intravascular device according to one embodiment. [Figure 2]

[0013] This is a perspective view of a force gauge for an intravascular device according to one embodiment. [Figure 3]

[0014] Figure 2 is a side view of a force gauge according to one embodiment. [Figure 4]

[0015] This is a side view of the force gauge shown in Figure 2, with the housing portion removed, according to one embodiment. [Figure 5]

[0016] This is a different side view of the force gauge shown in Figure 2, with the housing portion removed, according to one embodiment. [Figure 6]

[0017] This is a side view of a force gauge for an intravascular device, according to one embodiment, with the housing portion removed. [Figure 7]

[0018] This is a side view of a force gauge for an intravascular device, according to one embodiment, with the housing portion removed. [Figure 8]

[0019] This is a block diagram of a system for measuring the tensile force of an intravascular device according to one embodiment. [Figure 9]

[0020] This is a flowchart illustrating a method for using a system to measure the tensile force of an intravascular device, according to one embodiment. [Modes for carrying out the invention]

[0013]

[0021] In drawings, similar reference numbers generally indicate identical or similar elements. Furthermore, the leftmost digit of a reference number typically identifies the drawing in which it first appears.

[0014] Detailed explanation

[0022] Here, a representative embodiment shown in the accompanying drawings will be referred to in detail. References to "one embodiment", "an embodiment", "an exemplary embodiment", etc. indicate that the described embodiment may include certain features, structures, or characteristics, but not all embodiments necessarily include the specific features, structures, or characteristics. Further, such phrases do not necessarily refer to the same embodiment. Additionally, when a particular feature, structure, or characteristic is described in relation to one embodiment, it is presented that it is within the knowledge of those skilled in the art to affect such features, structures, or characteristics in relation to other embodiments, whether explicitly described or not.

[0015]

[0023] Removing the intravascular device after the procedure poses a risk of damaging the associated blood vessel due to pulling the intravascular device from the blood vessel. According to a first embodiment, a tensile force measuring device for an intravascular device is formed from a housing having a hollow tube configured to allow the intravascular device to pass through the housing. The hollow tube includes a bent portion including at least one support portion configured to limit the movement of the intravascular device. A force meter is disposed inside the housing and configured to measure the force applied to the force meter by the intravascular device. Optionally, a passage is configured in the housing to receive the hollow tube, and the passage is configured from one end of the housing to the other end of the housing.

[0016]

[0024] Some advantages of these and other embodiments disclosed herein are the easy and accurate measurement of the tensile force applied to the intravascular device. The disclosed devices and systems continuously measure the applied tensile force, display the measured force in a simple manner, and enable the operator of the intravascular device to obtain immediate and clear feedback regarding the applied tensile force. This reduces the risk of accidental damage to the associated blood vessel, thereby improving the patient's outcome.

[0017]

[0025] Figure 1 shows a perspective view of an intravascular device 1 for use in performing an endovascular procedure. The intravascular device 1 may be any type of intravascular device, including but not limited to devices for accessing or treating a target site, such as guidewires; catheters, such as microcatheters and aspiration catheters; stents; balloons; coils; stent retrievers and other devices for performing thrombectomy (including devices with mesh or snares); or embolization aids (such as devices with mesh or snares). The intravascular device 1 is generally sized and shaped to be at least partially inserted into the patient's blood vessel. The intravascular device 1 includes a distal end 2 configured to be inserted into the blood vessel and a proximal end 3 configured to remain outside the patient. Optionally, a handle 4 for the operator to manipulate the intravascular device 1 is located on the proximal end 3. In some embodiments, parts of the intravascular device, such as the distal end 2, may include a mechanical treatment portion. Examples of devices including mechanical treatment components include, but are not limited to, devices including expandable mesh, devices including snare, guidewires (e.g., maneuverable guidewires), balloon catheters, and stents. The force gauge 100 is attached to the intravascular device 1 near its proximal end 3 to measure the tensile force applied to the intravascular device 1 during an intravascular procedure. Alternatively, the intravascular device 1 is attached via the force gauge 100 near its proximal end 3 to measure the tensile force applied to the intravascular device 1 during an intravascular procedure.

[0018]

[0026] Figs. 2 to 3 are perspective and side views of an embodiment of the force meter 100. The housing 102 forms the main body of the force meter 100. The housing 102 of the force meter 100 can be formed in any suitable shape, for example, but not limited to, rectangular, square, hexagonal, tubular, trapezoidal, elliptical, round, can be tapered or non-tapered, and can have a smooth surface or a surface with irregularities. According to one embodiment, as shown in Figs. 2 to 3, the housing 102 can be formed in a trapezoidal shape where two opposite sides are longer than either of the other two sides. The housing 102 can be formed from any suitable material including, but not limited to, metals (e.g., stainless steel, nickel alloy, titanium, titanium alloy, or combinations thereof), plastics (e.g., thermoplastic materials such as polycarbonate, polypropylene, or polyethylene), silicone, or composite materials. In some embodiments, the housing 102 is shaped such that it can be comfortably held by hand by the user. The housing 102 is configured to function as a support structure for the elements of the force meter 100. According to some embodiments, the housing 102 is at least partially hollow. According to a particular embodiment, the housing 102 is configured to house the intravascular device 1 therein and measure the tensile force applied to the intravascular device 1.

[0019]

[0027] Two valves 104 are visible on the outside of the housing 102, with one valve 104 located at the first end of the housing 102 and the other valve 104 located at the second end of the housing 102. As will be described in detail below, the valves 104 are fluidly connected to the inside of the housing 102. The valves 104 are configured to allow the intravascular device 1 to enter through the housing 102 and into the patient's body. According to one embodiment, the valve 104 at the distal end of the housing 102 is similar to the valve 104 at the proximal end of the housing 102. According to one embodiment, the valve 104 at the distal end of the housing 102 is different from the valve 104 at the proximal end of the housing 102. According to a particular embodiment, the valve 104 located at the distal end of the housing 102 is configured as an adapter valve for connecting the housing 102 to a device for placing the intravascular device 1 into the patient's body, such as a catheter, e.g., a guide catheter. According to a particular embodiment, a valve 104 positioned at the proximal end of the housing 102 is configured as a passage valve that allows the intravascular device 1 to enter the patient's body through the housing 102. According to one embodiment, each of the valves 104 may form a fluid seal around the intravascular device 1. According to a particular embodiment, a valve 104 positioned at the proximal end of the housing 102 is configured to form a fluid seal around the intravascular device 1.

[0020]

[0028] An introduction port 105 located near one of the valves 104 is also shown. According to one embodiment, the introduction port 105 is located in close proximity to the valve 104 positioned at the distal end of the housing 102. The introduction port 105 is configured to allow a fluid or drug containing, for example, saline, contrast agent, or dye (e.g., for medical imaging such as X-ray, magnetic resonance imaging (MRI), computed tomography (CT), angiography, and ultrasound) to be introduced into the patient's body through a fluid-sealed space including the intravascular device 1, as will be described in detail below. The introduction port 105 may have its own valve or other mechanism to allow the introduction of the fluid while preventing leakage of any fluid. In some embodiments, there may be only one introduction port 105. In other embodiments, there may be no introduction port 105, or there may be two or more introduction ports 105. In some embodiments, it should be understood that the housing 102 can replace an existing catheter hub by including the valve 104 and the introduction port 105.

[0021]

[0029] Figures 2-3 show the cover 103 on the housing 102. The cover 103 can be secured to the rest of the housing 102 by any preferred method, including but not limited to mechanical fasteners, adhesives, or welding. In some embodiments, the cover 103 is intended to be removable, for example, for assembling or inspecting and repairing the force gauge 100. In other embodiments, the cover 103 is permanently fixed to the housing 102 during the manufacture of the force gauge 100 by a preferred technique (as described above).

[0022]

[0030] Figure 4 is a side view of one embodiment of the force gauge 100 with the cover 103 removed. This embodiment of the force gauge 100 shows a partially hollow housing 102. This means that the interior of the housing 102 is not completely hollow. Here, a completely hollow housing is, for example, a hollow rectangular parallelepiped shape with solid walls that do not substantially extend into the hollow interior. According to one embodiment, the interior of the housing 102 is at least partially solid and has openings or spaces for accommodating components of the force gauge 100 as needed. Typically, when the housing 102 is partially hollow, a passage 106 is defined within the housing 102 and connects the ends of the housing 102 that support the valve 104. Thus, the passage 106 connects two outer sides of the housing 102. Any two outer sides of the housing 102 can be connected by the passage 106. In the embodiment of Figure 4, two short sides of the housing 102 are connected by the passage 106. The passage 106 is sized to accommodate the intravascular device 1 as it passes through the housing 102. The passage 106 is formed with a straight section between the valves 104 and a curved section or similar section. This curved section forces the intravascular device 1 into a corresponding curved shape, which allows for force measurement, as will be described later.

[0023]

[0031] Figure 4 shows the tube 110. The tube 110 is a hollow tube that fluid-connects the valve 104 (and the introduction port 105, if applicable). The tube 110 is present in both partially hollow housings 102 and fully hollow housings 102. Typically, when the passage 106 is located within the housing 102 (usually in a partially hollow housing 102), the tube 110 passes through the passage 106. Thus, the tube 110 ensures that any fluid is contained within the housing 102 and kept isolated from other components found within the housing. The tube 110 also allows for the safe pressurization of fluid into the patient's vascular structure via the force gauge 100 (e.g., via the introduction port 105, described below). That is, the tube 110 can function as a fluid passage that allows fluid to pass through the force gauge 100. Thus, the tube 110 allows the force gauge to perform the endovascular procedure without affecting the procedure itself. The tube 110 is sized to allow passage of the endovascular device 1. The tube 110 is also typically flexible and configured to move with the intravascular device 1 when the intravascular device 1 bends. According to one embodiment, the material of the tube 110 is selected to have high flexibility. According to one embodiment, the material of the tube 110 is selected to have low friction with respect to the intravascular device 1. According to one embodiment, the material of the tube 110 is selected so as not to affect the baseline measurement of the force meter 100. According to one embodiment, the material of the tube 110 is selected so that the force measurement is affected by the force generated by the intravascular device 1, rather than by the tube 110. In some embodiments, the tube 110 may be selected from materials including, but not limited to, polytetrafluoroethylene ("PTFE") or Pebax. According to one embodiment, the tube 110 includes an internal coating or coil to minimize friction between the tube 110 and the intravascular device 1. Such a coating or coil may be selected from, but not limited to, a PTFE coating or a stainless steel coil.

[0024]

[0032] Support points 112 are also shown in Figure 4. Support points 112, also called support structures, are portions of the passage 106 configured to function as stops or supports for the intravascular device 1. These stops physically prevent the intravascular device 1 from moving beyond a specific point. Support points 112 may be separate inserts or elements embedded in the passage 106, as shown in Figure 4, or they may be formed as part of a wall defining the passage 106. Alternatively, support points 112 may be separate inserts or elements embedded in the housing 102, such as when the housing 102 is hollow and the passage 106 does not exist. In embodiments where support points 112 are separate inserts, these inserts may be selected to minimize friction between the tube 110 and the surface of the passage 106, or between the tube 110 and the support point 112 itself. For example, support points 112 may be patches of low-friction material such as PTFE, or devices such as rollers or other rotating structures. The support points 112 included in the force gauge 100 may be similar to or different from each other. It should be understood that the configuration of the pipe 110 and / or passage 106 at least partially determines the arrangement and number of support points 112. According to one embodiment, the required bend configuration of the pipe 110 and / or passage 106 at least partially determines the arrangement and number of support points 112. For example, the support points 112 include a single support point located within the housing 102. According to another embodiment, the support points 112 include two, three, four, five or more support points located within the housing 102. According to a particular embodiment, the support points 112 include two or three support points located within the housing 102. Therefore, in the embodiment of Figure 4, there are three support points 112. This is due to the double fold in the bend of the passage 106 in Figure 4. Other embodiments may have more or fewer support points 112 to house the tube 110 and the intravascular device 1 located inside it and to support their movement.

[0025]

[0033] A force sensor 120 is also shown in Figure 4. The force sensor 120 is positioned within the housing 102 and is configured to read the force applied from the interaction between the intravascular device 1 (through the hollow tube 110) and the force sensor 120. The force sensor 120 can be any suitable force sensor, including analog or digital sensors. Exemplary sensors that may be used according to some embodiments of the present invention include, but are not limited to, load cells, such as piezoelectric sensors or variable resistance sensors. The force sensor 120 is positioned inside the housing 102. According to a particular embodiment, the force sensor 120 is positioned inside the passage 106. According to a particular embodiment, the force sensor 120 is positioned in close proximity to a support point 112. The combination of the curved portion of the passage 106 and the support point 112 guides the intravascular device 1 to rest on the force sensor 120. In the embodiment shown in Figure 4, it should be noted that when the force sensor 120 is in direct contact with the hollow tube 110, the force sensor 120 is positioned adjacent to one of the support points 112 (the lowest central support point 112 in Figure 4). This combination of features also means that any force applied along the length of the intravascular device 1 will press the intravascular device 1 against the force sensor 120. The magnitude of the force applied to the intravascular device 1 directly corresponds to the force that the intravascular device 1 applies to the force sensor 120. Therefore, the force sensor 120 records a force that correlates with the force applied to the intravascular device 1.

[0026]

[0034] Figure 5 is a different side view of the embodiment of Figure 4, showing the opposite side of one embodiment of the force meter 100 with a portion of the housing 102 removed. Figure 5 shows a circuit board 130 located inside the housing 102. The circuit board 130 may contain some or all of the electronic components necessary for the operation of the force meter 100. In some embodiments, the circuit board 130 includes a processor and memory capable of storing and executing algorithms necessary for processing readings from the force sensor 120. Figure 8 is a system diagram of the electronic components of the force meter 100. As seen in Figure 8, the circuit board 130 includes one or more processors 131 and memory 132. The circuit board 130 is operably connected to the force sensor 120 to receive force data from the force sensor 120. This data is the force reading. This force reading is the force applied by the intravascular device 1 pressing against the force sensor 120, as described above. These readings are converted by the processor 131 into forces (e.g., tension, also called tensile force) applied along the length of the intravascular device 1, which can then be used to determine the corresponding force reading applied to the intravascular device 1 using experimentally determined equations or data tables. The circuit board 130 also includes a power supply 133 for supplying power to the electrical elements of the force meter 100. Any suitable power supply, such as but not limited to a battery, can be used for the power supply 133.

[0027]

[0035] A transmitter 134 is also located on the circuit board 130. The transmitter 134 may be a wired or wireless transmitter. The transmitter 134 is operably connected to the circuit board 130 and the processor 131, as described below, and is configured to receive calculated force measurements and transmit those measurements to a suitable external receiver. In some embodiments, the transmitter 134 may also include a receiving function. The transmitter 134 may be any suitable data transmitter, including but not limited to Universal Serial Bus ("USB"), Ethernet, Bluetooth, Wi-Fi, NFC, or other wireless data protocols. The transmitter 134 may also include two or more transmit / receive functions, such as USB and Bluetooth functions. In embodiments with wired communication capabilities, the transmitter 134 may include a suitable external interface or socket on the housing 102, which may be sealed with a removable plug.

[0028]

[0036] In some embodiments, the electronic components necessary for collecting and processing readings from the force sensor 120 may be located outside the housing 102. Therefore, the processor 131 may be located on a remote computing device having an external receiver 140 that contacts the force meter 130 via a transmitter 134. In these embodiments, there may still be a process located on the circuit board 130 inside the housing 102, but it should be understood that this processor can be programmed to receive sensor readings and transmit them using the transmitter 134.

[0029]

[0037] In some embodiments, the force indicator 136 is located within the housing 102 and operably connected to the circuit board 130. The force indicator 136 may be used to indicate the magnitude of the tensile force applied to the intravascular device 1. Figure 8 shows the force indicator 136 as an electrical component separate from the circuit board 130. However, it should be understood that the force indicator 136 may be at least partially physically located on the circuit board 130. In some embodiments, the force indicator 136 may be one or more lights visible from the outside of the housing 102. The lights may indicate force by changing color. For example, the force indicator 136 may display green when the force reading is below a predetermined limit, yellow when the force reading is approaching a predetermined limit, and red when the force reading exceeds a predetermined limit. Other light-based indicators are also possible, such as flashing lights to indicate that a predetermined limit has been exceeded.

[0030]

[0038] In some embodiments, the force indicator 136 may include a vibrating element located within the housing 102. This vibrating element can be used to produce vibrations that can be felt by a user holding the force gauge 100. The vibrating element can be used to produce various vibrations that indicate the tensile force being applied to the intravascular device 1. For example, intermittent vibrations may indicate that the force is approaching a predetermined limit, while constant vibrations may indicate that the force has exceeded a predetermined limit.

[0031]

[0039] In some embodiments, the force indicator 136 may also include an audio element located within the housing 102. This audio element can be used to produce sounds that can be heard by a user holding the force gauge 100. The audio element, like the vibration element described above, can produce a variety of sounds that indicate different tensile forces being applied to the intravascular device. For example, intermittent sounds may indicate that a predetermined force limit is being approached, while continuous sounds may indicate that a predetermined force limit has been exceeded.

[0032]

[0040] In some embodiments, the force indicator 136 may include a display screen located on the housing 102. The display screen can be any suitable type of display, including but not limited to an LCD display. The display screen can be used to display numerical force readings. The display screen can also display a graphical representation of the force readings, using numerical values ​​or graphs, such as bar graphs or line graphs, and can display caution icons and warning icons when the force is approaching and exceeding predetermined limits, respectively.

[0033]

[0041] Some embodiments of the force indicator 136 include combinations of the options described above. Any combination is possible. For example, the force indicator 136 may include both a vibration element and a light. According to another embodiment, the force indicator 136 may include both a sound element and a light. Other embodiments may include only a vibration element, only a sound element, or only a light.

[0034]

[0042] As shown in Figure 8, the transmitter 134 may be operably connected to an external receiver 140. The external receiver 140 may be any suitable computing device, including, for example, a laptop, desktop computer, mobile phone, or tablet. In some embodiments, the external receiver 140 is a computing device that includes a display which may be used to show force readings to the user of the force meter 100. This can serve as an alternative display of the force recorded by the force meter 100, either in combination with or instead of the force indicator 136.

[0035]

[0043] Figure 6 shows one embodiment of the force meter 100 having a different measurement arrangement configuration. The above considerations regarding the housing 102, valve 104, passage 106, support point 112, and tube 110 also apply here. This embodiment differs in that the force sensor 120 is positioned so as not to be in direct contact with the hollow tube 110. Instead, the force sensor 120 is positioned away from the tube 110 within the housing 102. A lever 122 having a pivot point 123 extends between the force sensor 120 and the tube 110, where the lever 122 is in contact with the intravascular device 1 (through the hollow tube 110). The force applied to the intravascular device 1 is transmitted to the lever 122, which then transmits the force to the force sensor 120. Although this force is not a direct measurement of tension, it is directly correlated with tension, and therefore these measurements can be used to calculate the tensile force by a suitable algorithm or an experimentally determined lookup table. The advantage of indirect measurement is that the arrangement of the lever 122 and the force sensor 120 allows the force measured by the force sensor 120 to be increased due to the lever action produced by this arrangement. This has the advantage of increasing the force being measured by the force sensor 120, thereby improving measurement accuracy, because the magnitude of the force in question is generally small, making it more difficult to accurately measure such forces. As a result, the sensitivity of the force sensor 120 can also be improved because the force being measured by the force sensor 120 is larger. Therefore, by using the positioning of the pivot point 123 and moving the pivot point 123 closer to the force sensor 120 (as shown in Figure 6), the force applied to the force sensor 120 can be increased. In either the direct contact embodiment in Figure 4 or the lever embodiment in Figure 6 (for example, showing indirect contact between the hollow tube 110 and the force sensor 120), an adjustment screw may be placed between the force sensor 120 and the associated structure (e.g., lever 122) to allow adjustment of the sensitivity and reading of the force sensor 120. The force sensor 120 is otherwise identical to the force sensor 120 described above. The considerations regarding the circuit board 130 and other electrical components described above also apply here.

[0036]

[0044] Figure 7 shows different embodiments of the force sensor 100 using a lever 122. In this embodiment, the valve 104 is not linearly positioned because the bend in the passage 106 is Z-shaped so that the valve 104 is not at the same height as the housing 102. In some embodiments of Figure 7, there are two fixed support points 112 that provide the Z-shape of the bend in the passage 106. According to some embodiments, the support points 112 are constructed as part of the lever 122. According to one embodiment, the lever 122 is positioned within the passage 106 and formed so that the hollow tube 110 and the intravascular device 1 pass through the lever 122. Thus, according to one embodiment, a passage is formed within the lever 122 so that the hollow tube passes through a clearly defined position of the lever 122. According to one embodiment, the pivot point 123 is positioned near the center of the lever 122. Alternatively, the positioning of the pivot point 123 may be modified to adjust the force applied to the force sensor 120, as described above. It will be understood that the force sensor 120 can be positioned above or below the lever 122, insofar as the force sensor contacts the lever 122, i.e., in direct contact or indirect contact (e.g., via an adjustment screw), as described above. A force applied along the length of the intravascular device 1 results in rotation of the lever 122 around the pivot point 123. For example, a tensile force applied from right to left in Figure 7 rotates the lever 122 counterclockwise due to the shape of the passage 106 and the lever 122. The lever 122 then contacts the force sensor 120, which measures the force as described above. This arrangement increases the force on the force sensor 120 for the same reasons described above. The remaining description above regarding the other components of the force meter 100 is equally applicable here as well.

[0037]

[0045] As shown in Figure 9, the method 300 using the force meter 100 is initiated in step 302 by inserting the intravascular device 1 into the force meter 100. As described above, the valve 104 can be used to seal the inside of the force meter 100 to avoid fluid flow. Step 304 includes applying a tensile force to the intravascular device 1. In step 306, the force sensor 120 detects the applied force, and the processor 131 processes that force into a corresponding tensile force applied to the intravascular device 1. In step 308, the resulting force is displayed to the user by the indicator 136 or by transmission to an external receiver 140 via the transmitter 134.

[0038]

[0046] Exemplary embodiments of the present invention are further provided below. [Examples]

[0039]

[0047] Example 1

[0048] A force meter for an intravascular device, comprising: a housing; a hollow tube disposed within the housing and formed with a bend, extending between two outer sides of the housing and configured to receive an intravascular device; at least one support point disposed within the housing and configured to contact the hollow tube and support the bend; and a sensor disposed within the housing and configured to sense a force applied by the intravascular device.

[0040]

[0049] Example 2

[0050] The force meter according to Embodiment 1, further comprising an electronic component located within a housing and configured to receive readings from a sensor and determine the force applied to an intravascular device based on the readings.

[0041]

[0051] Example 3

[0052] The force meter according to Embodiment 2, further comprising a transmitter located within a housing, the transmitter being operably connected to an electronic component, the electronic component being configured to use the transmitter to transmit at least one of a reading from a sensor or a force applied to an intravascular device to an external receiver.

[0042]

[0053] Example 4

[0054] The force meter according to Example 3 includes a wireless transmitter.

[0043]

[0055] Example 5

[0056] A force gauge according to any one of Examples 2 to 4, further comprising at least one of a processor and memory, which are disposed within a housing and operably connected to an electronic component.

[0044]

[0057] Example 6

[0058] A force meter according to any one of Examples 2 to 5, further comprising an indicator located within a housing, the indicator being operationally connected to an electronic component, the electronic component being configured to use the indicator to indicate the force applied to an intravascular device.

[0045]

[0059] Example 7

[0060] The force meter according to Embodiment 6 includes an indicator light located inside the housing and visible from outside the housing.

[0046]

[0061] Example 8

[0062] The force meter according to Example 6 includes a vibrating element located within the housing.

[0047]

[0063] Example 9

[0064] The force meter according to Embodiment 6 includes an audio element located within the housing.

[0048]

[0065] Example 10

[0066] A force gauge according to any one of Examples 1 to 9, further comprising a passage within the housing, which connects two outer sides of the housing and is configured to receive a hollow tube.

[0049]

[0067] Example 11

[0068] The force gauge according to Example 10, wherein at least one support point is located within the passage and configured to contact the hollow tube.

[0050]

[0069] Example 12

[0070] A force meter according to any one of Examples 1 to 11, further comprising a lever positioned within a housing, the lever fixed to a pivot, with one portion of the lever in contact with a hollow tube and a second portion of the lever in contact with a force sensor, and the lever configured to transmit a force applied from an intravascular device to the sensor.

[0051]

[0071] Example 13

[0072] The force meter according to any one of Examples 1 to 11, wherein the sensor is positioned in direct contact with the hollow tube.

[0052]

[0073] Example 14

[0074] A force meter according to any one of Examples 1 to 11, further comprising a lever located within a housing and fixed to a pivot, the lever including an opening that allows a hollow tube to pass through the lever, and the lever further configured to transmit a force applied from an intravascular device to a sensor.

[0053]

[0075] Example 15

[0076] The force gauge is a flexible hollow tube, as described in any one of Examples 1 to 14.

[0054]

[0077] Example 16

[0078] A force gauge according to any one of Examples 1 to 15, further comprising a valve located on the outer side of the housing, wherein a hollow tube is connected to the valve on the outer side of the housing, and the valve is configured to receive an intravascular device and fluid.

[0055]

[0079] Example 17

[0080] The force gauge according to Example 16 further includes an introduction port positioned in close proximity to at least one valve and configured to allow the introduction of fluid.

[0056]

[0081] Example 18

[0082] A system for measuring tensile force applied to an intravascular device, comprising a force gauge as described in any one of Examples 1 to 17, and an intravascular device positioned through a hollow tube of the force gauge.

[0057]

[0083] Example 19

[0084] The intravascular device is the system according to Example 18, comprising at least one of a thrombectomy device, a device including a snare, a device including a coil, a device including an expandable mesh, a guidewire, a balloon catheter, and a stent.

[0058]

[0085] Example 20

[0086] The system according to Example 18 or 19, wherein the tensile force applied to the intravascular device is at least partially affected when the intravascular device is retracted through the blood vessel.

[0059]

[0087] Example 21 A method for detecting tensile force applied to an intravascular device using a force gauge,

[0088] A method comprising passing an intravascular device through a force gauge according to any one of claims 1 to 17; detecting a force applied from the intravascular device to a force sensor located in a housing; and processing the force using an electronic component operably connected to the force sensor to determine a tensile force applied to the intravascular device.

[0060]

[0089] Example 22

[0090] The method according to Embodiment 21, further comprising transmitting at least one of the force or tensile force applied to the force sensor to an external receiver using a transmitter located within the housing.

[0061]

[0091] Example 23

[0092] The method according to Example 21 or 22, further comprising using an indicator placed inside the housing to show the tensile force applied to the intravascular device.

[0062]

[0093] Example 24

[0094] An example of demonstrating tensile force, according to claim 23, includes at least one of illuminating a light located inside the housing and visible from outside the housing, vibrating a vibrating element located inside the housing, and using a sound element located inside the housing.

[0063]

[0095] Example 25

[0096] The method according to any one of Examples 210-24, wherein detecting force involves detecting the movement of a lever located within a housing, the lever being fixed to a pivot and positioned such that one portion of the lever is in contact with a hollow tube and a second portion of the lever is in contact with a force sensor, and the lever is configured to transmit force applied from an intravascular device to the sensor.

[0064]

[0097] Example 26

[0098] The method according to any one of Examples 21 to 24, wherein force detection includes directly sensing the force from the hollow tube with a sensor.

[0065]

[0099] Example 27

[0100] The method according to any one of Examples 21 to 244, wherein detecting force further includes detecting the movement of a lever located within a housing, the lever being fixed to a pivot and positioned such that a portion of the lever is in contact with a hollow tube and a second portion of the lever is in contact with a force sensor, and the lever is configured to transmit force applied from an intravascular device to the sensor.

[0066]

[0101] It should be understood that the detailed description section, rather than the summary and abstract section, is intended to be used to interpret the claims. The summary and abstract section may describe one or more but not all exemplary embodiments of the invention, as considered by the inventors(s), and is therefore not intended to limit the scope of the invention and the appended claims. Furthermore, the embodiments described above do not limit the disclosure to those specifically shown and described above. Rather, the scope of the disclosure includes both combinations and partial combinations of the various features described above, as well as variations and modifications thereof that a person skilled in the art might conceive of by reading the above description and that are not disclosed in the prior art.

[0067]

[0102] The use of the modifiers “approximately” or “about” in this disclosure is intended to indicate that the relevant elements are subject to tolerance variations. Unless otherwise defined, the use of these modifiers in relation to units of measurement means a tolerance of plus or minus 10% of the unit of measurement. The use of these modifiers in relation to descriptions of shape, etc., is intended to allow for deformation of shape resulting from tolerance issues that are understood to commonly occur in the art.

[0068]

[0103] The above-mentioned descriptions of specific embodiments will fully reveal the general nature of the invention so that others, by applying their knowledge within the scope of their skill, can easily modify and / or adapt various applications, such as the specific embodiments, without departing from the general concept of the invention or without excessive experimentation. Accordingly, such adaptations and modifications are intended to be within the meaning and scope of equivalents of the disclosed embodiments, based on the teachings and guidance presented herein. It should be understood that the terms and phrases herein are for illustrative purposes only, not limitation, and should be interpreted by those skilled in the art in light of the teachings and guidance.

[0069]

[0104] For clarity, various features of the invention described in relation to separate embodiments may also be provided in combination in a single embodiment. Conversely, various features of the invention described in relation to a single embodiment for brevity may also be provided separately or in any preferred partial combination. The scope and breadth of the invention should not be limited by any of the above exemplary embodiments, but should be defined solely by the following claims and their equivalents.

Claims

1. A force gauge for intravascular devices, Housing and A hollow tube disposed within the housing and formed with a curved portion, extending between two outer sides of the housing and configured to receive the intravascular device, At least one support point is disposed within the housing and configured to contact the hollow tube and support the bent portion, A sensor located within the housing is configured to sense the force applied by the intravascular device. A force gauge including a force gauge.

2. The force meter according to claim 1, further comprising an electronic component disposed within the housing and configured to receive readings from the sensor and determine the force applied to the intravascular device based on the readings.

3. The force meter according to claim 2, further comprising a transmitter disposed within the housing, the transmitter being operably connected to the electronic component, the electronic component being configured to use the transmitter to transmit to an external receiver at least one of the readings from the sensor or the force applied to the intravascular device.

4. The force meter according to claim 3, wherein the transmitter includes a wireless transmitter.

5. The force gauge according to any one of claims 2 to 4, further comprising at least one of a processor and a memory disposed within the housing and operably connected to the electronic component.

6. The force meter according to any one of claims 2 to 5, further comprising an indicator disposed within the housing, wherein the indicator is operationally connected to the electronic component, and the electronic component is configured to use the indicator to indicate the force applied to the intravascular device.

7. The force meter according to claim 6, wherein the indicator is located inside the housing and includes a light visible from outside the housing.

8. The force meter according to claim 6, wherein the indicator includes a vibrating element disposed within the housing.

9. The force meter according to claim 6, wherein the indicator includes an audio element disposed within the housing.

10. The force gauge according to any one of claims 1 to 9, further comprising a passage within the housing, the passage connecting two outer sides of the housing and configured to receive the hollow tube.

11. The force gauge according to claim 10, wherein the at least one support point is located within the passage and configured to contact the hollow tube.

12. The force meter according to any one of claims 1 to 11, further comprising a lever disposed within the housing, wherein the lever is fixed to a pivot and positioned such that a portion of the lever contacts the hollow tube and a second portion of the lever contacts the force sensor, and the lever is configured to transmit a force applied from the intravascular device to the sensor.

13. The force meter according to any one of claims 1 to 11, wherein the sensor is positioned in direct contact with the hollow tube.

14. The force meter according to any one of claims 1 to 11, further comprising a lever disposed within the housing and fixed to a pivot, the lever including an opening for allowing the hollow tube to pass through the lever, and the lever further configured to transmit a force applied from the intravascular device to the sensor.

15. The force gauge according to any one of claims 1 to 14, wherein the hollow tube is a flexible hollow tube.

16. The force gauge according to any one of claims 1 to 15, further comprising a valve disposed on the outer side surface of the housing, wherein the hollow tube is connected to the valve on the outer side surface of the housing, and the valve is configured to receive the intravascular device and fluid.

17. The force gauge according to claim 16, further comprising an introduction port positioned in close proximity to the at least one valve and configured to allow the introduction of fluid.

18. A system for measuring the tensile force applied to intravascular devices, A force gauge according to any one of claims 1 to 17, The intravascular device positioned through the hollow tube of the force gauge and A system that includes this.

19. The system according to claim 18, wherein the intravascular device includes at least one of a thrombectomy device, a device including an expandable mesh, a device including a snare, a device including a coil, a guidewire, a balloon catheter, and a stent.

20. The system according to claim 18 or 19, wherein the tensile force applied to the intravascular device is at least partially affected when the intravascular device is retracted through the blood vessel.

21. A method for detecting tensile force applied to an intravascular device using a force gauge, Passing an intravascular device through the hollow tube of the force gauge according to any one of claims 1 to 17, The force applied from the intravascular device to the force sensor located within the housing is detected, Using an electronic component operably connected to the force sensor, the force is processed to determine the tensile force applied to the intravascular device. Methods that include...

22. The method according to claim 21, further comprising using a transmitter located within the housing to transmit at least one of the force applied to the force sensor or the tensile force to an external receiver.

23. The method according to claim 21 or 22, further comprising using an indicator disposed within the housing to indicate the tensile force applied to the intravascular device.

24. The method according to claim 23, wherein demonstrating the tensile force includes at least one of illuminating a light located inside the housing and visible from outside the housing, vibrating a vibrating element located inside the housing, and using an audio element located inside the housing.

25. The method according to any one of claims 21 to 24, wherein detecting the force further includes detecting the movement of a lever disposed within the housing, the lever being fixed to a pivot and positioned such that a portion of the lever is in contact with the hollow tube and a second portion of the lever is in contact with the force sensor, and the lever is configured to transmit a force applied from the intravascular device to the sensor.

26. The method according to any one of claims 21 to 24, further comprising detecting the force by directly sensing the force from the hollow tube with the sensor.

27. The method according to any one of claims 21 to 24, further comprising detecting the force by detecting the movement of a lever disposed within the housing and fixed to a pivot, wherein an opening is formed in the lever to allow a hollow tube to pass through the lever, and the lever is configured to transmit a force applied from the intravascular device to the sensor.

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