System and method for measuring force applied to intravascular device

Abstract

A dynamometer for detecting a force applied to an intravascular device, comprising: a housing; a channel in the housing configured to receive the intravascular device; and a sensor disposed in the housing to measure a force from the intravascular device to the housing. The dynamometer may also include a plurality of electronic components to process force readings from the sensor, transmit the plurality of readings to an external receiver, and indicate the plurality of force readings to a user.

Description

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

[0002] The following applications are incorporated herein by reference in their entirety: U.S. Provisional Application No. 63 / 381,288, filed Oct. 27, 2022; and U.S. Provisional Application No. 63 / 447,842, filed Feb. 23, 2023. BACKGROUND OF THE DISCLOSURE

[0003] The present disclosure relates to the field of intravascular medical devices. Specifically, the present disclosure relates to systems and methods for measuring forces applied to an intravascular device that is intended to be passed through a patient's blood vessel to a target region inside the patient's body to perform a medical procedure.

[0004] Examples of intravascular treatments of the type related to the present disclosure are the treatment of narrowing, blockage, or bleeding of blood vessels (including the neurovascular, cardiovascular, and peripheral vascular systems) using an intravascular device. For example, methods of treating an acute stroke caused by a blood vessel blockage in the brain typically include the intra-arterial administration of thrombolytic drugs such as recombinant tissue plasminogen activator (rtPA), mechanical removal of the blockage, or a combination of both. These interventional treatments must be performed within hours after the onset of symptoms. Both intra-arterial (IA) thrombolytic therapy and interventional thrombectomy involve accessing the blocked cerebral artery via intravascular techniques and devices.

[0005] Mechanical treatment involves physical manipulation to relieve the cause of the symptoms. For example, mechanical treatment of a blood clot involves physically removing the blood clot by various means, such as mechanically capturing the blood clot using a mesh, balloon, snare, or coil, which can be performed with or without supporting techniques similar to using aspiration to remove the clot or a stent to support the blood vessel. Another example of mechanical treatment is the mechanical remodeling of a blood vessel to improve blood flow, which is accomplished using mechanical devices similar to those discussed above.

[0006] After completion of this mechanical treatment, the intravascular device must be withdrawn from the blood vessel. Due to the limited space between the intravascular device and the blood vessel wall, the movement of the intravascular device within the body, particularly during withdrawal, can cause damage to the blood vessel through which the intravascular device moves. This problem is particularly relevant to intravascular devices having physical capture materials (e.g., blood clots) for removal. In these cases, the capture process typically involves a portion of the intravascular device having a larger cross-section, such as an expanded snare or mesh. This larger cross-section increases the friction between the intravascular device and the blood vessel, which increases the risk of damage.

[0007] Existing techniques for solving this problem involve training the operator of the intravascular device and using imaging techniques to detect unwanted movement of blood vessels during the retrieval process. Such training improves the problem to some extent, but it depends on the skills of individual operators and the situation may vary. Imaging can also be helpful, but it is essentially reactive because ideally, movement of blood vessels during retrieval should be completely avoided. Therefore, improved systems and methods are needed to ensure that excessive force is not applied during the retrieval of intravascular devices. Summary of the Invention

[0008] In one embodiment, a force gauge for an intravascular device includes: a housing; a hollow tube disposed in the housing, the hollow tube having a bent portion, the hollow tube extending between two outer sides of the housing and configured to receive the intravascular device; at least one support point disposed in the housing and configured to contact the hollow tube to support the bent portion; and a sensor disposed in the housing, the sensor configured to sense the force applied from the intravascular device.

[0009] In another embodiment, a system for measuring the pulling force applied to an intravascular device includes a force gauge of some embodiments of the present invention and an intravascular device disposed through the hollow tube of the force gauge.

[0010] In another embodiment, a method of using a force gauge to detect the pulling force applied to an intravascular device includes: passing the intravascular device through a force gauge of some embodiments of the present invention; detecting the force applied from the intravascular device to a force sensor disposed in the housing; and processing the force using an electronic component operably connected to the force sensor to determine the pulling force applied to the intravascular device.

[0011] Certain aspects of the present disclosure have other steps or elements in addition to or in place of those mentioned above. When referring to the accompanying drawings, for those skilled in the art, the steps or elements will become apparent by reading the following detailed description. Brief Description of the Drawings

[0012] The accompanying drawings, which are included herein and form a part of this specification, illustrate the present disclosure and, together with the description, further serve to explain the principles of the present disclosure and enable those skilled in the art to make and use the present disclosure.

[0013] Figure 1 Is a perspective view of an intravascular device according to one embodiment.

[0014] Figure 2 Is a perspective view of a force gauge for an intravascular device according to one embodiment.

[0015] Figure 3 Is according to one embodimentFigure 2 Side view of the dynamometer.

[0016] Figure 4 For one embodiment of Figure 2 Side view of the dynamometer with the housing part removed.

[0017] Figure 5 For one embodiment of Figure 2 Different side views of the dynamometer with the housing part removed.

[0018] Figure 6 Side view of the dynamometer for an intravascular device with the housing part removed.

[0019] Figure 7 Side view of the dynamometer for an intravascular device with the housing part removed.

[0020] Figure 8 Block diagram of a system for measuring the pulling force of an intravascular device according to one embodiment.

[0021] Figure 9 Flowchart of a method for using a system for measuring the pulling force of an intravascular device according to one embodiment.

[0022] In the drawings, like reference numerals generally indicate consistent or similar elements. Additionally, generally, the leftmost digit of a reference numeral can identify the drawing in which the reference numeral first appears. Detailed Description

[0023] Reference will now be made in detail to representative embodiments shown in the drawings. References to "one embodiment", "an embodiment", "exemplary embodiments", etc. indicate that the described embodiments may include specific features, structures, or characteristics, but not every embodiment necessarily includes the specific features, structures, or characteristics. Moreover, such phrases do not necessarily refer to the same embodiment. Further, when a specific feature, structure, or characteristic is described in connection with an embodiment, it is considered within the knowledge of those skilled in the art to combine such feature, structure, or characteristic with other embodiments, whether or not explicitly described.

[0024] Removing an intravascular device after performing a surgery 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 by a housing having a hollow tube configured to allow the intravascular device to pass through the housing. The hollow tube includes a bent portion having at least one support portion configured to restrict movement of the intravascular device. A force gauge is located inside the housing and configured to measure the force applied to the force gauge by the intravascular device. Optionally, a channel is configured in the housing to receive the hollow tube, and the channel is configured to extend from one end of the housing to the other end of the housing.

[0025] Some benefits of these and other embodiments disclosed herein are ease of use and accurate measurement of the tensile force applied to the intravascular device. The disclosed devices and systems continuously measure the applied tensile force and display the measured force in a simple manner, allowing the operator of the intravascular device to have immediate and clear feedback on the applied tensile force. This reduces the risk of accidentally damaging the associated blood vessel and thereby improves patient treatment outcomes.

[0026] Figure 1 A perspective view of an intravascular device 1 for performing an intravascular surgery is shown. The intravascular device 1 can be any type of intravascular device, including but not limited to a device for accessing a location of interest or a device for performing a treatment at a location of interest, such as a guide wire; a catheter, such as a microcatheter, a suction catheter; a stent; a balloon; a coil; a device for performing thrombectomy, such as a stent retriever (including a device comprising a mesh or a snare); or an embolization assist device (e.g., a device comprising a mesh or a snare). The size and shape of the intravascular device 1 are generally configured to be at least partially inserted into a 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 be held outside the patient. Optionally, a handle 4 is positioned at the proximal end 3 for an operator to use to manipulate the intravascular device 1. In some embodiments, a portion of the intravascular device, such as the distal end 2, may include a mechanical treatment portion. Embodiments of devices including a mechanical treatment portion include but are not limited to devices including an expandable mesh, a snare, a guide wire (e.g., a steerable guide wire), a balloon catheter, and a stent. A force gauge 100 is mounted near the proximal end 3 of the intravascular device 1 for measuring the tensile force applied to the intravascular device 1 during an intravascular surgery. Alternatively, the intravascular device 1 is assembled near the proximal end 3 by the force gauge 100 for measuring the tensile force applied to the intravascular device 1 during an intravascular surgery.

[0027] Figures 2 - 3Stereographic and side views of an embodiment of the dynamometer 100. The housing 102 forms the main body of the dynamometer 100. The housing 102 of the dynamometer 100 can be formed in any suitable shape, such as but not limited to rectangular, square, hexagonal, tubular, trapezoidal, oval, circular), can be conical or non-conical, and can have a smooth surface or an uneven surface. According to one embodiment, as Figures 2 - 3 seen, 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 of any suitable material, including but not limited to metals (e.g., stainless steel, nickel alloy, titanium, titanium alloy or combinations thereof), plastics (e.g., thermoplastics such as polycarbonate, polypropylene or polyethylene), silicone or composite materials. In some embodiments, the housing 102 is shaped to be comfortably held manually by a user. The housing 102 is configured to act as a support structure for the components of the dynamometer 100. According to some embodiments, the housing 102 is at least partially hollow. According to a specific embodiment, the housing 102 is configured to receive the intravascular device 1 therein and measure the tensile force on the intravascular device 1.

[0028] Two valves 104 are located outside the housing 102, one valve 104 being disposed at the first end of the housing 102 and the other valve 104 being disposed at the second end of the housing 102. The valves 104 are fluidly connected to the interior of the housing 102, as will be discussed in detail below. The valves 104 are configured to allow the intravascular device 1 to pass through and enter 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 specific 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 in the patient's body, such as a catheter (e.g., a guiding catheter). According to a specific embodiment, the valve 104 located at the proximal end of the housing 102 is configured as a channel valve that enables the channel of the intravascular device 1 to pass through the housing 102 and into the patient's body. According to one embodiment, each of the plurality of valves 104 can create a fluid-impermeable seal around the intravascular device 1. According to a specific embodiment, the valve 104 located at the proximal end of the housing 102 is configured to create a fluid-impermeable seal around the intravascular device 1.

[0029] Additionally, an introduction port 105 is shown in the figure, which is disposed near one of the plurality of valves 104. According to one embodiment, the introduction port 105 is disposed near the valve 104 positioned at the distal end of the housing 102. The introduction port 105 is configured to allow a fluid 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) or a medicament to enter the patient's body via the fluid-tight space containing the intravascular device 1, as will be discussed in detail below. The introduction port 105 may have its own valve or other mechanism to allow the introduction of fluid while preventing any fluid leakage. 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 more than one introduction port 105. It should be understood that in some embodiments, due to including a plurality of valves 104 and introduction ports 105, the housing 102 may replace an existing catheter hub.

[0030] Figures 2 - 3 A cover plate 103 on the housing 102 is shown in the figure. The cover plate 103 can be fixed to the rest of the housing 102 by any suitable method, including but not limited to mechanical fasteners, adhesives, or welding. In some embodiments, the cover plate 103 is intended to be removable, for example, for assembling or repairing the dynamometer 100. In other embodiments, the cover plate 103 is permanently fixed to the housing 102 during the manufacture of the dynamometer 100 by suitable techniques as discussed above.

[0031] Figure 4 A side view of an embodiment of the dynamometer 100 with the cover plate 103 removed is shown. This embodiment of the dynamometer 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 could be, for example, a hollow rectangular prism shape with solid walls that generally do not extend into the hollow interior. According to one embodiment, the interior of the housing 102 is at least partially solid, including openings or spaces to accommodate the elements of the dynamometer 100 as needed. Generally, when the housing 102 is partially hollow, a channel 106 is defined in the housing 102 and connects the ends of the housing 102 that support the valves 104. Thus, the channel 106 connects two outer sides of the housing 102. Any two outer sides of the housing 102 can be connected by the channel 106. In Figure 4 this embodiment, two shorter sides of the housing 102 are connected by the channel 106. The channel 106 is sized to accommodate the intravascular device 1 as it passes through the housing 102. The channel 106 forms a bend or deviation relative to a straight line between the valves 104. This bend forces the intravascular device 1 to be a corresponding bent shape, as will be discussed below, which allows for force measurement.

[0032] Figure 4Also shown is tube 110. Tube 110 is a hollow tube that fluidly connects multiple valves 104 (and inlet ports 105, if applicable). Tube 110 is present in a partially hollow and fully hollow housing 102. Generally, when channel 106 is present in housing 102 (usually in the partially hollow housing 102), tube 110 passes through channel 106. Thus, tube 110 ensures that any fluid remains contained within housing 102 and is separated from other components within the housing. Tube 110 also enables fluid to be safely pressed into a patient's vascular system via the force gauge 100 (e.g., via inlet port 105 discussed below). That is, tube 110 can act as a fluid path that allows fluid to pass through the force gauge 100. Thus, tube 110 can perform an intravascular procedure without affecting the force gauge during the procedure itself. Tube 110 is sized to allow the passage of the channel of the intravascular device 1 therethrough. Tube 110 is also generally configured to be flexible, and if the intravascular device 1 bends, then tube 110 moves with the intravascular device 1. According to one embodiment, the material selected for tube 110 is such that it will have high flexibility. According to one embodiment, the material selected for tube 110 is such that it will have low friction relative to the intravascular device 1. According to one embodiment, the material selected for tube 110 is such that it will not affect the baseline measurement of the force gauge 100. According to one embodiment, the material selected for tube 110 is such that the force measurement results will reflect the force generated by the intravascular device 1 rather than by tube 110. In some embodiments, tube 110 can be selected from materials including but not limited to polytetrafluoroethylene (“PTFE”) or Pebax. According to one embodiment, the interior of tube 110 includes a coating or coil to minimize the friction between tube 110 and the intravascular device 1. Such coatings or coils can be selected from but not limited to PTFE coatings or stainless steel coils.

[0033] Figure 4 Also shown is a support point 112. Support point 112 is the portion of channel 106 that is configured to act as a stop or support for the intravascular device 1, also referred to as a support structure. These stops physically prevent the intravascular device 1 from moving beyond a certain point. Support point 112 can be a separate insert or element embedded within channel 106, such as Figure 4As shown, or may also be formed as part of the wall defining the channel 106. Alternatively, for example, in the case where the housing 102 is hollow and the channel 106 does not exist, the support point 112 may be a separate insert or element embedded in the housing 102. In embodiments where the support point 112 is a separate insert, these inserts can be selected to minimize the friction between the tube 110 and the surface of the channel 106 or between the tube 110 and the support point 112 itself. For example, the support point 112 can be a patch of low-friction material such as PTFE, or can be a device such as a roller or other rotating structure. The support points 112 included in the force gauge 100 can be similar to each other or can be different from each other. It should be understood that the configuration of the tube 110 and / or the channel 106 at least partially determines the support point 112 and the placement and number thereof. According to one embodiment, the required bending configuration of the tube 110 and / or the channel 106 at least partially determines the placement and number of the support points 112. For example, the support point 112 includes a single support point disposed in the housing 102. According to another embodiment, the support point 112 includes two, three, four, five or more support points disposed in the housing 102. According to a specific embodiment, the support point 112 includes two or three support points disposed in the housing 102. Thus, in Figure 4 the embodiment, there are three support points 112. This is because Figure 4 of the double-turn shape of the bend of the channel 106 in. Other embodiments may have more or fewer support points 112 to accommodate and support the movement of the tube 110 and the intravascular device 1 therein.

[0034] Figure 4 The force sensor 120 is also shown in. The force sensor 120 is positioned inside 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 an analog sensor or a digital sensor. Exemplary sensors that can 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 specific embodiment, the force sensor 120 is positioned inside the channel 106. According to a specific embodiment, the force sensor 120 is positioned close to the support point 112. The combination of the bent portion of the channel 106 and the support point 112 guides the intravascular device 1 against the force sensor 120. It should be noted that in Figure 4 the embodiment, where the force sensor 120 is in direct contact with the hollow tube 110, the force sensor 120 is adjacent to one of the plurality of support points 112 (in Figure 4In [the device], it is placed at the bottom center support point 112). This combination of features also means that any force applied along the length of the intravascular device 1 will cause the intravascular device 1 to press against the force sensor 120. The magnitude of the force applied to the intravascular device 1 directly corresponds to the force exerted by the intravascular device 1 on the force sensor 120. Thus, the force sensor 120 records a force related to the force applied to the intravascular device 1.

[0035] Figure 5 is Figure 4 a different side view of an embodiment of [the device], which shows the opposite side of an embodiment of the dynamometer 100 with a portion of the housing 102 removed. Figure 5 Shows the circuit board 130 disposed in the housing 102. The circuit board 130 may contain some or all of the electronic components necessary for the operation of the dynamometer 100. In some embodiments, the circuit board 130 includes a processor and a memory capable of storing and running algorithms necessary to process the readings of the force sensor 120. Figure 8 is a system diagram of the electronic components of the dynamometer 100. As Figure 8 seen, the circuit board 130 includes one or more processors 131 and a memory 132. The circuit board 130 is operatively connected to the force sensor 120 to receive force data from the force sensor 120. This data is the force reading. As explained above, this force reading is the force exerted by the intravascular device 1 pressing against the force sensor 120. These readings are converted by the processor 131 into the force (e.g., tension, also known as tensile force) applied along the length of the intravascular device 1, and the processor can use experimentally determined equations or data tables to determine the corresponding force readings applied to the intravascular device 1. The circuit board 130 also includes a power supply 133 for powering the electrical components of the dynamometer 100. Any suitable power supply, such as but not limited to a battery, can be used for the power supply 133.

[0036] In addition, a transmitter 134 is also disposed on the circuit board 130. The transmitter 134 can be a wired or wireless communication transmitter. The transmitter 134 is operatively connected to the circuit board 130 and the processor 131, which is configured to receive the calculated force measurements and send those measurements to a suitable external receiver, as will be discussed below. In some embodiments, the transmitter 134 may also include receiving capabilities. The transmitter 134 can 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 more than one transmission / receiving capability, such as USB capability and Bluetooth capability. In embodiments with wired communication capabilities, the transmitter 134 may include a suitable external interface or socket on the housing 102, which can be sealed with a removable plug.

[0037] In some embodiments, the electronics required to collect and process the readings of the force sensor 120 may be located outside the housing 102. Accordingly, the processor 131 described above may be located on a remote computing device having an external receiver 140 connected to the dynamometer 130 via a transmitter 134. It should be understood that in these embodiments, there may still be a processor disposed on the circuit board 130 within the housing 102, but this processor may be programmed to receive the sensor readings and transmit the sensor readings using the transmitter 134.

[0038] In some embodiments, a force indicator 136 is disposed within the housing 102 and is operatively connected to the circuit board 130. The force indicator 136 can be used to indicate the magnitude of the pulling force applied to the intravascular device 1. Figure 8 The force indicator 136 is depicted 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 disposed on the circuit board 130. In some embodiments, the force indicator 136 may be one or more lights visible from the exterior of the housing 102. The lights can 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 the predetermined limit, and red when the force reading exceeds the predetermined limit. Other light-based indications are possible, such as a flashing light to indicate exceeding a predetermined limit.

[0039] In some embodiments, the force indicator 136 may include a vibration element disposed within the housing 102. This vibration element can be used to generate vibrations that can be felt by a user holding the dynamometer 100. The vibration element can be used to generate various vibrations to indicate the pulling force applied to the intravascular device 1. For example, intermittent vibrations can indicate that a predetermined force limit is being approached, while constant vibrations can indicate that the predetermined force limit has been exceeded.

[0040] In some embodiments, the force indicator 136 may further include an audio element disposed within the housing 102. This audio element can be used to generate sounds that can be heard by a user holding the dynamometer 100. The audio element can generate various sounds to indicate different pulling forces applied to the intravascular device, similar to the vibration element discussed above. For example, intermittent sounds can indicate that a predetermined force limit is being approached, while constant sounds can indicate that the predetermined force limit has been exceeded.

[0041] In some embodiments, the force indicator 136 may include a display screen disposed on the housing 102. The display screen may be any suitable type of display, such as but not limited to an LCD display. The display screen may be used to display a numerical force reading. The display screen may also display a graphical indication of the force reading, such as but not limited to using numbers or using graphics (e.g., bar chart or line chart), and may display attention and warning icons when approaching and exceeding a predetermined force limit, respectively.

[0042] Some embodiments of the force indicator 136 include a combination of the options discussed 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 an audio element and a light. Other embodiments may include only a vibration element, only an audio element, or only a light.

[0043] As Figure 8 seen, the transmitter 134 is operatively connected to an external receiver 140. The external receiver 140 may be any suitable computing device, including for example a laptop computer, a desktop computer, a cell phone, or a tablet computer. In some embodiments, the external receiver 140 is a computing device that includes a display that can be used to display the force reading to the user of the dynamometer 100. This may serve as an alternative indication of the force recorded by the dynamometer 100, in combination with or as an alternative to the force indicator 136.

[0044] Figure 6An embodiment of the force gauge 100 with different measurement arrangements is shown. The above discussion regarding the housing 102, valve 104, channel 106, support point 112, and tube 110 applies equally here. This embodiment differs in that the force sensor 120 is placed such that it does not directly contact the hollow tube 110. Instead, the force sensor 120 is placed separately from the tube 110 in the housing 102. A lever 122 with a pivot point 123 extends between the force sensor 120 and the tube 110, where the lever 122 contacts the intravascular device 1 (through the hollow tube 110). The force applied to the intravascular device 1 will be transmitted to the lever 122, which in turn transmits the force to the force sensor 120. Although this force is not a direct measurement of the tensile force, it is directly related to the tensile force, and thus these measurements can be used to calculate the tensile force through a suitable algorithm or a look-up table determined experimentally. The advantage of the 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 multiplied due to the leverage generated by this arrangement. This has the benefit of increasing the force measured by the force sensor 120, which improves the measurement accuracy, since the magnitude of the forces being discussed is generally small, making those forces more difficult to measure accurately. This can also improve the sensitivity of the force sensor 120, since the force measured by the force sensor 120 is larger. Thus, by moving the pivot point 123 closer to the force sensor 120 (as Figure 6 shown), the positioning of the pivot point 123 can be used to multiply the force applied to the force sensor 120. In the Figure 4 direct contact embodiment or Figure 6 the lever embodiment (e.g., presenting indirect contact between the hollow tube 110 and the force sensor 120), an adjustment screw can be placed between the force sensor 120 and the relevant structure (e.g., the lever 122) to allow adjustment of the sensitivity and reading of the force sensor 120. The force sensor 120 is otherwise consistent with the force sensor 120 discussed above. The above discussion of the circuit board 130 and other electronic components applies equally here.

[0045] Figure 7 A different embodiment of the force gauge 100 using the lever 122 is shown. In this embodiment, the multiple valves 104 are not linearly arranged, since the bend in the channel 106 is z-shaped, such that the multiple valves 104 are not on the same level of the housing 102. In Figure 7In some embodiments, there are two fixed support points 112 that provide the Z-shaped bend of the channel 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 disposed in the channel 106 and is formed such that the hollow tube 110 and the intravascular device 1 pass through the lever 122. Thus, according to one embodiment, a channel is formed in the lever 122 to allow the hollow tube to pass through a well-defined position of the lever 122. According to one embodiment, the pivot point 123 is located near the center of the lever 122. Alternatively, the positioning of the pivot point 123 can be changed to adjust the force applied to the force sensor 120, as discussed above. It should be understood that the force sensor 120 can be placed above or below the lever 122 as long as it is in contact with the lever 122, i.e., direct contact or indirect contact (e.g., via an adjustment screw), as discussed above. A force applied along the length of the intravascular device 1 will cause the lever 122 to rotate about the pivot point 123. For example, due to the shape of the channel 106 and the lever 122, a pulling force applied from right to left in Figure 7 will cause the lever 122 to rotate counterclockwise. The lever 122 contacts the force sensor 120, which measures the force as discussed above. For the same reasons discussed above, this arrangement causes the force on the force sensor 120 to be multiplied. The remaining discussion of the other elements of the dynamometer 100 above applies equally here.

[0046] As Figure 9 shown, the method 300 of using the dynamometer 100 begins at step 302: by inserting the intravascular device 1 into the dynamometer 100. As discussed above, the valve 104 can be used to seal the interior of the dynamometer 100 to avoid fluid flow. Step 304 involves applying a pulling force to the intravascular device 1. At step 306, the force sensor 120 detects the applied force, and the processor 131 processes the force as the corresponding pulling force applied to the intravascular device 1. At step 308, the resulting force is displayed to the user by the indicator 136 or by transmitting it via the transmitter 134 to an external receiver 140.

[0047] Exemplary embodiments of the present invention are further provided below.

[0048] Example 1

[0049] A dynamometer for an intravascular device, comprising: a housing; a hollow tube disposed in the housing, the hollow tube having a bend formed therein, the hollow tube extending between two outer sides of the housing and configured to receive the intravascular device; at least one support point disposed in the housing and configured to contact the hollow tube to support the bend; and a sensor disposed in the housing and configured to sense a force applied from the intravascular device.

[0050] Example 2

[0051] The force gauge according to Embodiment 1 further includes a plurality of electronic components, the plurality of electronic components being disposed in the housing and configured to receive readings from the sensor and determine the force applied to the intravascular device based on the readings.

[0052] Example 3

[0053] The force gauge according to Embodiment 2 further includes a transmitter disposed in the housing, the transmitter being operably connected to the plurality of electronic components, wherein the plurality of electronic components are configured to use the transmitter to send at least one of the readings from the sensor or the force applied to the intravascular device to an external receiver.

[0054] Example 4

[0055] The force gauge according to Embodiment 3, wherein the transmitter includes a wireless transmitter.

[0056] Example 5

[0057] The force gauge according to any one of Embodiments 2 to 4 further includes at least one of a processor and a memory disposed in the housing and operably connected to the plurality of electronic components.

[0058] Example 6

[0059] The force gauge according to any one of Embodiments 2 to 5 further includes an indicator disposed in the housing, the indicator being operably connected to the plurality of electronic components, wherein the plurality of electronic components are configured to use the indicator to indicate the force applied to the intravascular device.

[0060] Example 7

[0061] The force gauge according to Embodiment 6, wherein the indicator includes a light disposed in the housing and visible from the outside of the housing.

[0062] Example 8

[0063] The force gauge according to Embodiment 6, wherein the indicator includes a vibration element disposed in the housing.

[0064] Example 9

[0065] The force gauge according to Embodiment 6, wherein the indicator includes an audio element disposed in the housing.

[0066] Example 10

[0067] The force gauge according to any one of Embodiments 1 to 9 further includes a channel in the housing, the channel connecting two outer sides of the housing and configured to receive a hollow tube.

[0068] Example 11

[0069] The force gauge according to Embodiment 10, wherein at least one support point is disposed in the channel and configured to contact the hollow tube.

[0070] Example 12

[0071] The force gauge according to any one of Embodiments 1 to 11 further includes a lever disposed in the housing, the lever being fixed to a pivot and positioned such that one part of the lever contacts the hollow tube and a second part of the lever contacts a force sensor, the lever being configured to transmit a force applied from an intravascular device to the sensor.

[0072] Example 13

[0073] The force gauge according to any one of Embodiments 1 to 11, wherein the sensor is positioned to be in direct contact with the hollow tube.

[0074] Example 14

[0075] The force gauge according to any one of Embodiments 1 to 11 further includes a lever disposed in the housing and fixed to a pivot, the lever having an opening to allow the hollow tube to pass through the lever, the lever further being configured to transmit a force applied from an intravascular device to the sensor.

[0076] Example 15

[0077] The force gauge according to any one of Embodiments 1 to 14, wherein the hollow tube is a flexible hollow tube.

[0078] Example 16

[0079] The force gauge according to any one of Embodiments 1 to 15 further includes a valve disposed on an outer side of the housing, wherein the hollow tube is connected to the valve at the outer side of the housing, the valve being configured to receive an intravascular device and a fluid.

[0080] Example 17

[0081] The force gauge according to Embodiment 16 further includes an introduction port disposed adjacent to at least one valve and configured to allow introduction of a fluid.

[0082] Example 18

[0083] A system for measuring the pulling force applied to an intravascular device, comprising: a dynamometer according to any one of Embodiments 1 to 17; and an intravascular device disposed to pass through the hollow tube of the dynamometer.

[0084] Example 19

[0085] The system according to Embodiment 18, wherein the intravascular device comprises at least one of the following: a clot retrieval device, a device comprising a snare, a device comprising a coil, a device comprising an expandable mesh, a guide wire, a balloon catheter, and a stent.

[0086] Example 20

[0087] The system according to Embodiment 18 or 19, wherein when the intravascular device is retracted within a blood vessel, the pulling force applied to the intravascular device is at least partially affected.

[0088] Example 21

[0089] A method of using a dynamometer to detect the pulling force applied to an intravascular device, comprising: passing the intravascular device through a dynamometer according to any one of claims 1 to 17; detecting the force applied from the intravascular device to a force sensor disposed within a housing; and processing the force using an electronic component operably connected to the force sensor to determine the pulling force applied to the intravascular device.

[0090] Example 22

[0091] The method according to Embodiment 21, further comprising transmitting at least one of the force applied to the force sensor or the pulling force to an external receiver using a transmitter disposed within the housing.

[0092] Example 23

[0093] The method according to any one of Embodiments 21 to 22, further comprising indicating the pulling force applied to the intravascular device using an indicator disposed within the housing.

[0094] Example 24

[0095] The embodiment according to claim 23, wherein indicating the pulling force comprises at least one of the following: illuminating a lamp disposed within the housing and visible from the outside of the housing, vibrating a vibration element disposed within the housing, and using an audio element disposed within the housing.

[0096] Example 25

[0097] The method according to any one of embodiments 210 to 24, wherein detecting the force includes detecting movement of a lever disposed in a housing, the lever being fixed to a pivot and positioned such that one portion of the lever contacts a hollow tube and a second portion of the lever contacts a force sensor, the lever being configured to transmit a force applied from an intravascular device to the sensor.

[0098] Example 26

[0099] The method according to any one of embodiments 21 to 24, wherein detecting the force includes directly sensing, by a sensor, a force from the hollow tube.

[0100] Example 27

[0101] The method according to any one of embodiments 21 to 244, wherein detecting the force further includes detecting movement of a lever disposed in a housing, the lever being fixed to a pivot and positioned such that one portion of the lever contacts a hollow tube and a second portion of the lever contacts a force sensor, the lever being configured to transmit a force applied from an intravascular device to the sensor.

[0102] It should be understood that the detailed description section, rather than the summary and abstract sections, is intended to be used to interpret the claims. The summary and abstract sections may set forth one or more exemplary embodiments contemplated by the inventor but not all exemplary embodiments, and thus are not intended to limit the invention and the appended claims in any way. Additionally, the embodiments described above do not limit the present disclosure to what has been specifically shown and described above. Rather, the scope of the present disclosure includes combinations and sub - combinations of the various features described above and their variations and modifications that would occur to a person of ordinary skill in the art upon reading the foregoing description and that are not disclosed in the prior art.

[0103] In the present disclosure, the use of the modifiers "substantially" or "about" is intended to indicate that the associated element is subject to variations within a tolerance range. Unless otherwise defined, the use of these modifiers with respect to measurement units means a tolerance of plus or minus ten percent of the measurement unit. The use of these modifiers with respect to descriptions such as shape is intended to allow for variations in the shape due to tolerance issues, as typically occur in the art as commonly understood.

[0104] The foregoing description of the specific embodiments will so fully reveal the general nature of the invention that others can, by applying knowledge within the skill of the art, readily modify and / or adapt various applications of these specific embodiments without undue experimentation and without departing from the general concept of the invention. Therefore, based on the teachings and guidance presented herein, these adaptations and modifications are intended to be within the meaning and scope of the equivalents of the disclosed embodiments. It should be understood that the phraseology or terminology herein is for the purpose of description and not of limitation, so that the terminology or phraseology of this specification shall be interpreted by those skilled in the art in light of the teachings and guidance.

[0105] The various features of the invention described in the context of separate embodiments for clarity can also be provided in combination in a single embodiment. Conversely, for the sake of brevity, the various features of the invention described in the context of a single embodiment can also be provided separately or in any suitable sub-combination. The breadth and scope of the invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.

Claims

1. A dynamometer for an intravascular device, characterized in that, Comprising: A housing; A hollow tube disposed within the housing, the hollow tube having a bend formed therein, the hollow tube extending between two outer sides of the housing and configured to receive the intravascular device; At least one support point disposed within the housing and configured to contact the hollow tube to support the bend; And A sensor disposed within the housing, the sensor configured to sense a force applied from the intravascular device.

2. The dynamometer according to claim 1, characterized in that, Further comprising a plurality of electronic components disposed within the housing and configured to receive a reading from the sensor and determine a force applied to the intravascular device based on the reading.

3. The dynamometer according to claim 2, wherein Further comprising a transmitter disposed within the housing, the transmitter operably connected to the plurality of electronic components, wherein the plurality of electronic components are configured to use the transmitter to send at least one of the reading from the sensor or the force applied to the intravascular device to an external receiver.

4. The dynamometer according to claim 3, characterized in that, The transmitter comprises a wireless transmitter.

5. The dynamometer according to any one of claims 2 to 4, characterized in that Further comprising at least one of a processor and a memory disposed within the housing and operably connected to the plurality of electronic components.

6. The dynamometer according to any one of claims 2 to 5, characterized in that, Further comprising an indicator disposed within the housing, the indicator operably connected to the plurality of electronic components, wherein the plurality of electronic components are configured to use the indicator to indicate the force applied to the intravascular device.

7. The dynamometer according to claim 6, wherein The indicator comprises a light disposed within the housing and visible from the outside of the housing.

8. The dynamometer according to claim 6, characterized in that, The indicator comprises a vibration element disposed within the housing.

9. The dynamometer according to claim 6, wherein, The indicator comprises an audio element disposed within the housing.

10. The dynamometer according to any one of claims 1 to 9, characterized in that, Further comprising a channel within the housing, the channel connecting two outer sides of the housing and configured to receive the hollow tube.

11. The dynamometer according to claim 10, characterized in that, The at least one support point is disposed within the channel and configured to contact the hollow tube.

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

13. The dynamometer according to any one of claims 1 to 11, characterized in that, The sensor is positioned in direct contact with the hollow tube.

14. The dynamometer according to any one of claims 1 to 11, characterized in that Further comprising a lever disposed within the housing and fixed to a pivot, the lever having an opening to allow the hollow tube to pass through the lever, the lever further configured to transmit a force applied from the intravascular device to the sensor.

15. The dynamometer according to any one of claims 1 to 14, characterized in that, The hollow tube is a flexible hollow tube.

16. The dynamometer according to any one of claims 1 to 15, characterized in that, Further comprising a valve disposed on an outer side of the housing, wherein the hollow tube is connected to the valve at the outer side of the housing, the valve configured to receive the intravascular device and a fluid.

17. The dynamometer according to claim 16, characterized in that, Further comprising an introduction port disposed adjacent to at least one valve and configured to allow introduction of a fluid.

18. A system for measuring the pulling force applied to an intravascular device, characterized in that, Comprising: A dynamometer according to any one of claims 1 to 17; And An intravascular device disposed to pass through the hollow tube of the dynamometer.

19. The system according to claim 18, wherein The intravascular device includes at least one of the following: a clot retrieval device, a device including an expandable mesh, a device including a snare, a device including a coil, a guide wire, a balloon catheter, and a stent.

20. The system according to claim 18 or 19, characterized in that, When the intravascular device is retracted within a blood vessel, the pulling force applied to the intravascular device is at least partially affected.

21. A method for detecting the pulling force applied to an intravascular device using a dynamometer, characterized in that, Comprising: Passing the intravascular device through a hollow tube of the force gauge according to any one of claims 1 to 17; Detecting a force applied from the intravascular device to a force sensor disposed within the housing; And Processing the force using an electronic component operably connected to the force sensor to determine the pulling force applied to the intravascular device.

22. The method according to claim 21, wherein Further comprising transmitting at least one of the force applied to the force sensor or the pulling force to an external receiver using a transmitter disposed within the housing.

23. The method according to any one of claims 21 to 22, characterized in that, Further comprising indicating the pulling force applied to the intravascular device using an indicator disposed within the housing.

24. The method according to claim 23, wherein Indicating the pulling force includes at least one of the following: illuminating a lamp disposed within the housing and visible from the exterior of the housing, vibrating a vibration element disposed within the housing, and using an audio element disposed within the housing.

25. The method according to any one of claims 21 to 24, characterized in that, Detecting the force further includes detecting movement of a lever disposed within the housing, the lever being fixed to a pivot and positioned such that one portion of the lever contacts the hollow tube and a second portion of the lever contacts the force sensor, the lever being 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, characterized in that, Detecting the force further includes directly sensing the force from the hollow tube by the sensor.

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

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