JP-2026514273-A - 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.

Inventors

• ヴァクニン，ユヴァル
• コーンブラウ，ジオラ
• フリードマン，アハロン
• シュヴェディン，アナトリー

Assignees

• ラピッド メディカル リミテッド

Dates

Publication Date

20260508

Application Date

20231026

Priority Date

20221027

Claims (20)

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 force meter including a sensor disposed within the housing that is configured to sense the force applied by the intravascular device.
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, wherein the transmitter is operably connected to the electronic component, and the electronic component is configured to use the transmitter to transmit at least one of the readings from the sensor or the force applied to the intravascular device to an external receiver.
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 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 includes a light located within the housing and 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 positioned 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 the 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 by 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 meter according to claim 16, further comprising an introduction port positioned adjacent to 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, A system including an intravascular device positioned through the hollow tube of the force meter.
19. The system according to claim 18, wherein the intravascular device includes at least one of a thrombus retrieval 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.

Description

Cross-referencing and referencing of related applications [0001] The following applications are incorporated herein by reference in their entirety: U.S. Provisional Patent Application No. 63/381,288, filed October 27, 2022, and U.S. Provisional Patent Application No. 63/447,842, filed February 23, 2023. background [0002] This disclosure relates to the field of intravascular medical devices. Specifically, this disclosure relates to a system and method for measuring the force applied to an intravascular device intended to pass through a patient's blood vessels to a target area within the patient's body in order to perform a medical procedure. [0003] Examples of the types of endovascular treatments relating to this disclosure include the use of endovascular devices to treat stenosis, occlusion, or bleeding of blood vessels, including neurovascular, cardiovascular, and peripheral blood vessels. For example, treatment of acute stroke caused by occlusion of blood vessels in the brain typically involves either intra-arterial administration of thrombolytic agents such as recombinant tissue plasminogen activator (rtPA), mechanical removal of the occlusion, or a combination of these two. These interventional treatments must be performed within a few hours of symptom onset. Both intra-arterial (IA) thrombolytic therapy and interventional thrombectomy involve accessing the occluded cerebral artery via endovascular techniques and devices. [0004] Mechanical interventions involve physical manipulation of the relevant structure to alleviate the cause of the symptoms. For example, mechanical interventions of thrombi include the 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] 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, particularly during retraction, can damage the blood vessel as the device moves, due to the limited space between the device and the 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 typically 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] Current techniques to address this situation require training operators of intravascular devices and using imaging techniques to detect undesirable vascular movement during the withdrawal process. While training improves this problem to some extent, it relies on the varying skills of individual operators. Imaging is also helpful, but since vascular movement during withdrawal is ideally completely avoided, in practice it becomes a reactive measure. Therefore, improved systems and methods are needed to ensure that excessive force is not applied during the withdrawal of intravascular devices. [0012] A perspective view of an intravascular device according to one embodiment.[0013] A perspective view of a force gauge for an intravascular device according to one embodiment.[0014] This is a side view of the force gauge shown in Figure 2 according to one embodiment.[0015] This is a side view of the force gauge of Figure 2 with the housing portion removed, according to one embodiment.[0016] This is a different side view of the force gauge of Figure 2, in which the housing portion has been removed, according to one embodiment.[0017] This is a side view of a force gauge for an intravascular device, according to one embodiment, with the housing portion removed.[0018] This is a side view of a force gauge for an intravascular device, according to one embodiment, with the housing portion removed.[0019] This is a block diagram of a system for measuring the tensile force of an intravascular device according to one embodiment.[0020] This is a flowchart of a method for using a system for measuring the tensile force of an intravascular device according to one embodiment. [0021] In drawings, similar reference numbers indicate elements that are generally identical or similar. Furthermore, generally, the leftmost digit of a reference number identifies the drawing in which that reference number first appears. Detailed explanation [0022] Hereinafter, we refer in detail to representative embodiments shown in the accompanying drawings. References such as “one embodiment,” “an embodiment,” and “an exemplary embodiment” indicate that th