Force sensor, force sensing catheter, ablation device and medical apparatus

Abstract

A force sensor, comprising a sensor body (100), the sensor body (100) comprising a first section (10), a second section (20), and a middle section (30) located between the first section (10) and the second section (20) and connecting the first section (10) and the second section (20). At least part of the outer surface of the middle section (30) is recessed inwardly with respect to the outer surface of the first section (10) and the outer surface of the second section (20), so as to form a gap (40) between the first section (10) and the second section (20). The sensor body (100) further comprises an annular portion, the annular portion defining at least part of an axial boundary of the gap (40), and the thickness of the annular portion being less than the width of an annular surface thereof. Also disclosed are a force sensing catheter, an ablation device, and a medical apparatus.

Description

Force sensors, force sensing catheters, ablation devices, and medical equipment

[0001] This application claims priority to Chinese Patent Application No. 202410058363.4 filed on January 15, 2024 and Chinese Patent Application No. 202420098134.0 filed on January 15, 2024. The contents of the above-mentioned Chinese patent application disclosures are hereby incorporated by reference in their entirety as part of this application. Technical Field

[0002] The present disclosure relates to the field of medical devices, and in particular to a force sensor. The force sensor is particularly suitable for a catheter-based diagnosis and treatment system. The present disclosure also relates to a force sensing catheter having the force sensor, and an ablation device. Background Art

[0003] Atrial fibrillation (AF) is one of the most common arrhythmias in clinical practice, with a prevalence of 0.4% to 1% in the general population, and its incidence rate increases significantly with age. The disease can lead to high disability and mortality rates. Catheter ablation can cure atrial fibrillation (AF) and improve patients' symptoms, and the effectiveness of ablation is closely related to the degree of contact between the ablation catheter and the atrial tissue. Permanent transmural damage at all atrial fibrillation ablation points is the key to ensuring a high success rate of the operation and reducing recurrence, and it is also the difficulty of ablation. The research and development of new pressure contact monitoring catheters focuses on improving adhesion to tissues, improving the safety of catheter operation, and being able to better control the size of damage at the ablation point, thereby increasing the effectiveness of ablation.

[0004] It is desirable to provide a force sensor that can be used in this scenario, which has low sensitivity differences in various directions and high overall accuracy. Summary of the Invention

[0005] In response to the above-mentioned problems and needs, the present disclosure proposes a force sensor, which solves the above-mentioned problems and brings other technical effects by adopting the following technical features.

[0006] The present disclosure provides a force sensor comprising a sensor body, the sensor body including a first segment, a second segment, and an intermediate segment located between and connecting the first and second segments. At least a portion of an outer surface of the intermediate segment is recessed inward relative to the outer surfaces of the first and second segments to form a gap between the first and second segments. The sensor body further comprises an annular portion defining at least a portion of an axial boundary of the gap, wherein the thickness of the annular portion is less than the width of its annular surface.

[0007] According to one embodiment, the annular portion includes a first annular portion and a second annular portion, wherein the first annular portion defines a part of the axial boundary of the gap and connects the first end of the middle segment and the first segment, and the second annular portion defines a part of the axial boundary of the gap and connects the second end of the middle segment and the second segment.

[0008] According to an embodiment, the annular portion extends in a transverse direction perpendicular to the axial direction or makes an angle between 0 and 15° with respect to the transverse direction.

[0009] According to one embodiment, the first segment, the second segment and the middle segment each have a side wall surrounding the hollow portion, wherein the side wall of the middle segment is parallel to the side wall of the first segment and the side wall of the second segment.

[0010] According to one embodiment, the first segment, the second segment and the middle segment all have circular cross-sections, wherein the outer diameter of the middle segment is smaller than the inner diameter of the first segment and smaller than the inner diameter of the second segment; and the first segment and the second segment have the same inner diameter and outer diameter.

[0011] According to one embodiment, one of the first segment and the second segment is directly connected to the middle segment, and the other of the first segment and the second segment is connected to the middle segment via the annular portion.

[0012] According to one embodiment, the middle section has a first recessed portion, a second recessed portion and a central section connecting the first recessed portion and the second recessed portion, and the first recessed portion and the second recessed portion are both recessed relative to the outer surfaces of the first section, the second section and the central section to form two gaps; wherein the annular portion includes a first annular portion and a second annular portion, the first annular portion connects the first end of the central section and the first recessed portion, and the second annular portion connects the second end of the central section and the second recessed portion.

[0013] According to an embodiment, the force sensor further comprises an optical sensor device extending through the first section and the second section in the axial direction.

[0014] According to one embodiment, the optical sensor device includes: a plurality of reflective members extending axially through the first section; and a plurality of optical fibers extending axially through the second section, the number of which is equal to the number of reflective members. One end of each reflective member extends into the gap and is opposite to an end of each optical fiber extending into the gap.

[0015] According to one embodiment, the width-to-thickness ratio of the annular portion is between 2-3.

[0016] According to one embodiment, the sensor body is an integrated structure.

[0017] The present disclosure also provides a force sensing catheter, comprising a flexible elongated body having a distal end; and a force sensor according to any one of the above items, the force sensor being arranged at the distal end within the flexible elongated body.

[0018] The present disclosure also provides an ablation device, which includes the force sensor according to any embodiment or the ablation device according to any embodiment.

[0019] Hereinafter, the best embodiment for implementing the present disclosure will be described in more detail with reference to the accompanying drawings so that the features and advantages of the present disclosure can be easily understood. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the following briefly introduces the drawings of the embodiments of the present disclosure. The drawings are only used to illustrate some embodiments of the present disclosure, and are not intended to limit all embodiments of the present disclosure to these drawings.

[0021] 1A , 1B, 1C, 1D, and 1E show various views of a force sensor according to a first embodiment of the present disclosure;

[0022] 2A , 2B, 2C, 2D, and 2E illustrate various views of a force sensor according to a first embodiment of the present disclosure, wherein the optical sensor device is omitted compared to FIGS. 1A , 1B, 1C, 1D, and 1E;

[0023] 3A, 3B, and 3C show various views of a force sensor according to a second embodiment of the present disclosure;

[0024] 4A, 4B, and 4C show various views of a force sensor according to a third embodiment of the present disclosure;

[0025] 5A, 5B, and 5C show various views of a force sensor according to a fourth embodiment of the present disclosure;

[0026] FIG6 illustrates a dimensioned cross-sectional view of a force sensor according to a first embodiment of the present disclosure;

[0027] 7A , 7B, 7C, and 7D illustrate various views of a force sensor according to a fifth embodiment of the present disclosure;

[0028] 8A, 8B, 8C, 8D, and 8E show various views of a force sensor according to a sixth embodiment of the present disclosure;

[0029] 9A , 9B, and 9C illustrate various views of a force sensor according to a seventh embodiment of the present disclosure.

[0030] REFERENCE SIGNS LIST 100 sensor body 10 first section 20 second section 30 intermediate section 31 first end of intermediate section 32 second end of intermediate section 41 first annular portion 42 second annular portion 40 gap 33 first recessed portion 34 second recessed portion 35 central section 351 first end of central section 352 second end of central section 36 accommodation portion 200 optical sensor device 51 reflecting member 52 optical fiber 43 hole DETAILED DESCRIPTION

[0031] In order to make the purpose, technical solution and advantages of the technical solution of the present disclosure clearer, the technical solution of the embodiment of the present disclosure will be clearly and completely described below in conjunction with the drawings of the specific embodiments of the present disclosure. The same figure marks in the drawings represent the same parts. It should be noted that the described embodiments are part of the embodiments of the present disclosure, not all of the embodiments. Based on the described embodiments of the present disclosure, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present disclosure.

[0032] Compared to the embodiments shown in the drawings, feasible embodiments within the scope of protection of the present disclosure may have fewer components, additional components not shown in the drawings, different components, differently arranged components, or differently connected components, etc. In addition, two or more components in the drawings may be implemented in a single component, or a single component shown in the drawings may be implemented as multiple separate components.

[0033] Unless otherwise defined, the technical or scientific terms used herein shall have the ordinary meaning understood by persons of ordinary skill in the field to which the present disclosure belongs. The words "first", "second" and similar terms used in the patent application specification and claims of the present disclosure do not indicate any order, quantity or importance, but are only used to distinguish different components. Similarly, words such as "one" or "a" do not necessarily indicate a quantity limitation. Words such as "include" or "comprise" mean that the elements or objects appearing before the word include the elements or objects listed after the word and their equivalents, without excluding other elements or objects. Words such as "connect" or "connected" are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "Up", "down", "left", "right" and the like are only used to indicate relative positional relationships. When the absolute position of the object being described changes, the relative positional relationship may also change accordingly.

[0034] In various embodiments of the present disclosure, including those shown in the accompanying drawings and those not shown in the accompanying drawings, the sensor body of the force sensor includes at least two segments that are deformable relative to each other, and the two segments may be cylindrical or cylindrical-like structures. The two parts are connected by an annular portion, and the annular portion is configured so that the deformation between the two segments that are movable with respect to each other mainly occurs in the annular portion.

[0035] First, a force sensor according to a first embodiment of the present disclosure will be described with reference to Figures 1A to 2E . It should be noted that, in the present disclosure, features described for any embodiment may also be applied to other embodiments without causing any contradiction.

[0036] Figures 1A, 1B, 1C, 1D, and 1E respectively illustrate a side view, a perspective view, a side view from another angle, a cross-sectional view taken along a central plane, and a top view of the force sensor. Compared to Figures 1A-1E, Figures 2A-2E only show sensor body 100, omitting optical sensor device 200. Figures 2A, 2B, 2C, 2D, and 2E respectively illustrate a side view, a cross-sectional view taken along a central plane, a perspective view, a top view, and a cross-sectional view through intermediate section 30 of sensor body 100.

[0037] The force sensor includes a sensor body 100 and an optical sensor device 200 held by the sensor body 100. The sensor body 100 includes a first section 10, a second section 20, and an intermediate section 30 located between and connecting the first and second sections 10, 20. In the present disclosure, the first section 10 may also be referred to as the distal end of the force sensor, and the second section 20 may also be referred to as the proximal end of the force sensor. Each of the first section 10, the second section 20, and the intermediate section 30 is preferably a hollow cylindrical structure surrounded by sidewalls, particularly a cylindrical structure having a circular cross-section.

[0038] The outer surface of the middle section 30 is recessed inward relative to the outer surfaces of the first section 10 and the second section 20, thereby forming a gap 40 between the first section 10 and the second section 20. When a force is applied to the distal end of the force sensor, i.e., the location of the first section 10, the first section 10 deforms relative to the second section 20, thereby changing the axial dimension of the gap 40.

[0039] The sensor body 100 also includes a first annular portion 41 and a second annular portion 42, which together define the two axial boundaries of the gap 40. The first annular portion 41 connects the first end 31 of the intermediate section 30 with the first section 10, and the second annular portion 42 connects the second end 32 of the intermediate section 30 with the second section 20. In this disclosure, the first annular portion 41 and the second annular portion 42 may be collectively referred to as annular portions. In this disclosure, annular portions are thin-walled structures, meaning their thickness is less than the width of their annular surfaces.

[0040] Due to the thin-walled shape, when the distal end of the force sensor is subjected to force, deformation between the first and second segments 10, 20 occurs primarily within the first and second annular portions 41, 42. Because the first and second annular portions 41, 42 are not located on the cylindrical outer surface of the sensor body 100, but rather in a highly concealed and difficult-to-reach location during operation, the deformed portion is protected from direct force, improving the accuracy of sensor force measurements.

[0041] Moreover, since the annular portion is a symmetrical annular structure with the central axis of the sensor body 100 as the central axis, the cross-sectional inertia moment of the sensor body 100 in all directions can be completely equal, thereby minimizing the sensitivity difference of the sensors in all directions and improving the overall accuracy of the sensor.

[0042] Preferably, the thickness of the annular portion is smaller than the thickness of any one of the first segment 10 and the second segment 20. More preferably, the thickness of the annular portion is smaller than the thickness of any one of the first segment 10, the second segment 20 and the middle segment 30.

[0043] The degree of thinness of the annular portion can also be specifically expressed by the annular portion's width-to-thickness ratio. The width of the annular portion, that is, the width of the annular surface of the annular portion, is equal to the distance between the outer and inner peripheral edges of the annular portion, and is also equal to the distance between the two components it connects. Taking the embodiment of Figure 6 as an example, the width of the first annular portion 41 is the distance between the first section 10 and the middle section 30, and the width of the second annular portion 42 is the distance between the second section 20 and the middle section 30. In the first embodiment, the width of the annular portion is also equal to the length of the annular portion extending in the radial direction. The width of the annular portion is marked with w in Figure 6.

[0044] The thickness of the annular portion is the wall thickness of the annular portion. For annular portions extending in the transverse direction, the wall thickness can be measured in the axial direction. For annular portions with non-uniform thickness, the thickness can be the average thickness or the thickness at its center. The width of the annular portion is indicated by d in Figure 6.

[0045] The width-to-thickness ratio of the annular portion is greater than 1, preferably, the width-to-thickness ratio of the annular portion is greater than or equal to 2, or greater than or equal to 2.5, or greater than or equal to 3. Preferably, the width-to-thickness ratio of the annular portion is between 2-4, particularly preferably, the width-to-thickness ratio of the annular portion is between 2-3.

[0046] The force sensor disclosed herein is extremely small. The outer diameter of the sensor body 100 is generally in the range of 1.5 mm to 3 mm, the length of the sensor body 100 is in the range of 1 mm to 8 mm, and the thickness of the annular portion is in the range of 0.05 mm to 0.1 mm, for example, 0.06 mm. In this case, if the width-to-thickness ratio is too high, manufacturing and processing will be difficult and the structural strength of the sensor body 100 will be reduced. By setting the width-to-thickness ratio (w / d) of the annular portion between 2 and 3, sufficient deformation is provided to improve the accuracy of the sensor, while also ensuring the sensor's structural strength and reducing manufacturing difficulties.

[0047] In this first embodiment, both the first annular portion 41 and the second annular portion 42 extend in a transverse direction perpendicular to the axial direction of the sensor body 100. In other embodiments, the first annular portion 41 and / or the second annular portion 42 may be angled relative to the transverse direction at an angle between 0 and 30°, more preferably between 0 and 15°, and even more preferably between 0 and 10°. Enabling the annular portions to extend substantially parallel to the transverse direction helps ensure that deformation between the first segment 10 and the second segment 20 occurs primarily in the first annular portion 41 and the second annular portion 42.

[0048] The sensor body 100 preferably satisfies one or more of the following features:

[0049] 1. The sensor body 100 is an integrated structure.

[0050] 2. The first section 10 , the second section 20 and the middle section 30 all have circular cross sections, wherein the outer diameter of the middle section 30 is smaller than the inner diameter of the first section 10 and smaller than the inner diameter of the second section 20 .

[0051] 3. The sidewalls of the middle section 30 are parallel to the sidewalls of the first section 10 and the sidewalls of the second section 20 .

[0052] 4. The first section 10 and the second section 20 have the same inner diameter and outer diameter.

[0053] By means of these features, and in particular the combination of two or more of these features, the sensor body 100 can be manufactured in a simple manner using a standard cylindrical blank.

[0054] Taking the structure of the sensor body 100 shown in Figures 2A-2E as an example, the manufacturing method may include: (1) providing a cylindrical blank having a certain wall thickness; (2) widening the inner diameter at the first end of the cylindrical blank to form the inner surface of the first section 10; (3) widening the inner diameter at the second end of the cylindrical blank to form the inner surface of the second section 20; (4) machining a groove from the outer wall of the cylindrical blank to form the gap 40. The aforementioned steps (2), (3), and (4) do not need to be performed in the order described, but can be performed in any order.

[0055] Among them, the manufacturing methods include but are not limited to laser processing, oil-cut wire cutting, electric discharge machining, etc.

[0056] The optical sensor device 200 of the force sensor is held by the sensor body 100 and is configured to sense deformation of the sensor body 100 caused by a force and transmit a signal representative of the deformation. In some embodiments, the optical sensor device 200 is a combination of a reflective member 51 and an optical fiber 52. In other embodiments, the optical sensor device 200 is a Bragg grating of the optical fiber 52.

[0057] There can be multiple optical sensor devices 200, each housed in a housing 36. In some embodiments, the housing 36 can be a through-hole, such as a circular, elliptical, polygonal, square, rectangular, or irregularly shaped through-hole. In other embodiments, the housing 36 can be a groove open to the outer surface of the sensor body 100, and the cross-sectional shape of the groove can be composed of an arc, a curve, a straight line, or a combination of curves. As shown in Figures 2C, 2D, and 2E, the first segment 10 and the second segment 20 each have three housings 36, and in each segment, the three housings 36 are evenly spaced near the circumference.

[0058] The optical sensor device 200 can be a combination of reflective members 51 and optical fibers 52. A plurality of reflective members 51 extend axially through the first section 10, and a plurality of optical fibers 52 extend axially through the second section 20, the number of which is equal to the number of reflective members 51. This creates a one-to-one correspondence between the reflective members 51 and the optical fibers 52. The embodiment shown in Figures 1A-1E illustrates this approach. One end of each reflective member 51 extends into the gap 40, opposite the end of each optical fiber 52 extending into the gap 40. A gap exists between the ends of the reflective members 51 and the ends of the optical fibers 52. The optical fibers 52 are configured to transmit light to the reflective members 51 and to collect light reflected from the reflective members 51. Light is emitted from the end faces of the optical fibers 52 and passes through the gaps to reach the end faces of the corresponding reflective members 51. Similarly, light reflected from the reflective members 51 passes through the gaps to reach the optical fibers 52. When the sensor is subjected to force, deformation occurs at the annular portion between the first section 10 and the second section 20, causing a change in the distance between the end face of the optical fiber 52 and the end face of the reflective component 51. This change in distance can be used to obtain the magnitude and direction of the force applied to the sensor, as described below.

[0059] The force sensor disclosed herein can adopt the following three demodulation schemes.

[0060] The first method utilizes the principle of white-light interferometry demodulation. This solution applies to the case where the optical sensor device 200 comprises a reflective member 51 and an optical fiber 52. When a force is applied to the sensor's distal end, the annular portion between the second segment 20 and the first segment 10 deforms, causing the distance between the reflective member 51 and the optical fiber 52 to change. By calculating the change in the distance between the reflective member 51 and the optical fiber 52 at three or more locations distributed across the gap 40 using the principle of white-light interferometry demodulation, the magnitude and direction of the force applied to the distal end can be calculated.

[0061] The second method utilizes the principle of light intensity demodulation. This solution applies to the case where the optical sensor device 200 comprises a reflective member 51 and an optical fiber 52. When a force is applied to the sensor's distal end, the annular portion of the second segment 20 and the first segment 10 deforms, causing the distance between the reflective member 51 and the optical fiber 52 to change. This distance change causes a change in the intensity of light reflected from the end face of the reflective member 51 and received by the optical fiber 52. By measuring the change in light intensity at three or more locations distributed across the gap 40, the magnitude and direction of the force applied to the distal end can be calculated.

[0062] The third approach utilizes the principle of a fiber 52 Bragg grating (FBG). This solution applies to the case where the optical sensor device 200 is a fiber 52 Bragg grating (FBG). The ends of the FBG are secured within the housings 36 of the second segment 20 and the first segment 10, respectively. When a force is applied to the sensor's distal end, the annular portion between the second segment 20 and the first segment 10 deforms, causing tension or compression on the FBG. When the FBG is subjected to tension or compression, its central wavelength changes accordingly. By measuring the change in the central wavelength of the FBG at three or more locations distributed across the gap 40, the magnitude and direction of the force applied to the distal end can be calculated.

[0063] The following describes force sensors according to other embodiments of the present disclosure with reference to Figures 3A-5C. In these embodiments, the configuration of the first section 10, the second section 20, and the middle section 30 is similar to that of the first embodiment, and each has two annular portions. These embodiments differ from the first embodiment primarily in the specific shapes of the annular portions.

[0064] Figures 3A, 3B, and 3C show various views of a force sensor according to a second embodiment of the present disclosure. In this second embodiment, the annular portion has a non-uniform wall thickness. In a cross-sectional view taken along the center plane of the sensor body 100, the first annular portion 41 and the second annular portion 42 have a right-angled trapezoidal shape. The wall thickness of the first annular portion 41 and the second annular portion 42 decreases as they approach the central axis of the force sensor and increases as they move further away from the central axis. The surfaces of the first annular portion 41 and the second annular portion 42 that are close to the gap 40 extend generally along the transverse direction of the sensor body 100, while the surfaces of the first annular portion 41 and the second annular portion 42 that are away from the gap 40 form an acute angle relative to the transverse direction of the sensor body 100. Alternatively, both surfaces of the first annular portion 41 and the second annular portion 42 may be formed at an acute angle relative to the transverse direction of the sensor body 100, or the surfaces of the first annular portion 41 and the second annular portion 42 near the gap 40 may be formed at an acute angle relative to the transverse direction of the sensor body 100, while the surfaces of the first annular portion 41 and the second annular portion 42 away from the gap 40 extend substantially along the transverse direction of the sensor body 100. Providing uneven wall thicknesses of the annular portions further reduces the difficulty of manufacturing the force sensor.

[0065] Figures 4A, 4B, and 4C show various views of a force sensor according to a third embodiment of the present disclosure. In this third embodiment, in a cross-sectional view along the center plane of the sensor body 100, the first annular portion 41 and the second annular portion 42 have a parallelogram shape. The first annular portion 41 and the second annular portion 42 form an acute angle relative to the transverse direction of the sensor body 100. This acute angle is preferably less than 30°, and more preferably less than 15°. By allowing the annular portion to have an inclination angle controlled within a certain range, it is possible to ensure that the deformation of the first section 10 relative to the second section 20 occurs primarily in the annular portion, while allowing the processing accuracy requirements of the sensor body 100 to be reduced.

[0066] Figures 5A, 5B, and 5C illustrate various views of a force sensor according to a fourth embodiment of the present disclosure. In this fourth embodiment, in a cross-sectional view taken along the central plane of the sensor body 100, the first annular portion 41 and the second annular portion 42 have irregular shapes. Rather than being flat, thin walls, the first annular portion 41 and the second annular portion 42 have annular surfaces formed by curved surfaces. In this embodiment, the size of the gap 40 increases as it moves away from the central axis, and the two axial sides of the gap 40 are defined by curved lines. This approach also reduces the machining precision requirements for the sensor body 100 while ensuring that deformation of the first segment 10 relative to the second segment 20 primarily occurs in the annular portions.

[0067] Figures 7A-7D illustrate a force sensor according to a fifth embodiment of the present disclosure. This embodiment has only one annular portion, namely, a first annular portion 41. The second segment 20 is directly connected to the middle segment 30, and the first segment 10 is connected to the middle segment 30 via the annular portion. It will be appreciated that in unillustrated embodiments, the first segment 10 can be directly connected to the middle segment 30, while the second segment 20 is connected to the middle segment 30 via the annular portion. Furthermore, in unillustrated embodiments, the outer diameter of the second segment can be smaller than that of the first segment, or even equal to the outer diameter of the middle segment 30.

[0068] As shown in this embodiment, the thickness of the section directly connected to the middle section 30, here the second section 20, is set so that its inner peripheral surface is continuous with the inner peripheral surface of the middle section 30. This simplifies the manufacturing steps because the step of widening the interior of the second section 20 can be omitted.

[0069] The wall thickness of the first section 10 is set so that its inner peripheral surface is farther from the central axis than the outer peripheral surface of the middle section 30 to leave space for the annular portion.

[0070] 8A-8E show a force sensor according to a sixth embodiment of the present disclosure. Unlike the previous embodiments, this embodiment has two gaps 40.

[0071] Specifically, the sensor body 100 of the sixth embodiment can be divided into three sections: a first section 10, a second section 20, and an intermediate section 30 connecting the first and second sections 10, 20. The intermediate section 30 has a first recessed portion 33, a second recessed portion 34, and a central section 35 connecting the first and second recessed portions 33, 34. Both the first and second recessed portions 33, 34 are recessed relative to the outer surfaces of the first and second sections 10, 20, and central section 35 to form two gaps 40.

[0072] The annular portion of this embodiment includes a first annular portion 41 and a second annular portion 42 . The first annular portion 41 connects the first end 351 of the central section 35 and the first recessed portion 33 , and the second annular portion 42 connects the second end 352 of the central section 35 and the second recessed portion 34 .

[0073] By forming two gaps 40 and forming annular portions beside the two gaps 40 , deformation of the entire sensor body 100 is facilitated, and overall measurement accuracy is improved.

[0074] In the sixth embodiment, it is preferred that the first section 10 , the first recessed portion 33 , the second section 20 , and the second recessed portion 34 have the same inner diameter to simplify the processing steps.

[0075] When manufacturing the sensor of the sixth embodiment, only the following steps are required: (1) providing a cylindrical blank; (2) machining the first concave portion 33; (3) machining the second concave portion 34; and (4) widening the middle portion of the middle section 30. Steps (2) to (4) do not need to be performed in the order described and can be performed in any order.

[0076] Figures 9A-9C illustrate a force sensor according to a seventh embodiment of the present disclosure. This embodiment is similar to the first embodiment, differing primarily in that the annular portion is discontinuous and instead divided into two or more sector-shaped segments. In embodiments with two sector-shaped segments, the two sectors are preferably identical. For more than two sector-shaped segments, they are preferably evenly distributed along the circumference to minimize differences in sensor sensitivity in different directions. These sector-shaped segments can be separated by holes 43, as shown in Figure 9C.

[0077] The force sensor of any embodiment of the present disclosure can be disposed in a force sensing catheter having a flexible, elongated body with a distal end, the force sensor being disposed within the flexible, elongated body at the distal end. The force sensor compresses or bends in response to a contact force applied to the distal end of the flexible, elongated body, such as a contact force generated when the distal end contacts the wall of a blood vessel or organ. The force sensing catheter can have a width and length suitable for insertion into a blood vessel or organ in the human body. The force sensing catheter can include a proximal portion, a mid-portion, and a distal portion, the distal portion of which can include an end effector housing the force sensor.

[0078] End effectors such as those known in the art for diagnosis or treatment of blood vessels or organs, such as mapping electrodes or ablation electrodes, may be used in conjunction with any embodiment of the present disclosure. For example, the force sensors of the present disclosure may be used in mapping electrodes or ablation electrodes. In addition, the force sensing catheter may be configured as an electrophysiology catheter to perform cardiac mapping and ablation. In other embodiments, the force sensing catheter may be configured to deliver drugs or bioactive agents to the wall of a blood vessel or organ, or to perform minimally invasive procedures such as transmyocardial revascularization or cryoablation.

[0079] The specific structure of the force sensing catheter used in the force sensor of the present disclosure is not limited. Depending on the application, the force sensing catheter can be a hollow structure (ie, having an inner cavity) or a non-hollow structure (ie, without an inner cavity).

[0080] The force sensor of any embodiment of the present disclosure can be incorporated into an ablation device. Furthermore, the force sensing catheter of any embodiment of the present disclosure can be incorporated into an ablation device, or the force sensing catheter itself can serve as an ablation device. The ablation device can be used to treat conditions such as atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, and cardiac tumors.

[0081] The ablation device may include a catheter for delivering energy (e.g., radiofrequency energy, cryoenergy, etc.) to a specific location in the heart. A force sensor may be mounted, for example, at the catheter tip to monitor the contact force between the catheter and cardiac tissue in real time. This monitoring helps ensure adequate contact between the catheter and the target tissue, enhancing ablation effectiveness.

[0082] The present disclosure also relates to a medical device, which may include a force sensor according to any embodiment of the present disclosure, or a force sensing catheter according to any embodiment of the present disclosure.

[0083] The exemplary implementation schemes proposed in the present disclosure are described in detail above with reference to preferred embodiments. However, it will be understood by those skilled in the art that, without departing from the concept of the present disclosure, various modifications and variations can be made to the above-mentioned specific embodiments, and various technical features and structures proposed in the present disclosure can be combined in various ways without exceeding the scope of protection of the present disclosure, which is determined by the appended claims.

Claims

1. A force sensor, characterized in that, the force sensor includes a sensor body (100), and the sensor body (100) includes a first section (10), a second section (20), and an intermediate section (30) located between the first section (10) and the second section (20) and connecting the first section (10) and the second section (20); at least a part of the outer surface of the intermediate section (30) is recessed inward relative to the outer surfaces of the first section (10) and the second section (20) to form a gap (40) between the first section (10) and the second section (20); the sensor body (100) further includes an annular portion that defines at least a part of the axial boundary of the gap (40), wherein the thickness of the annular portion is less than the width of its annular surface.

2. The force sensor according to claim 1, characterized in that, the annular portion includes a first annular portion (41) and a second annular portion (42), the first annular portion (41) defines a part of the axial boundary of the gap (40) and connects the first end (31) of the intermediate section (30) to the first section (10), and the second annular portion (42) defines a part of the axial boundary of the gap (40) and connects the second end (32) of the intermediate section (30) to the second section (20).

3. The force sensor according to claim 1, characterized in that, the annular portion extends in a transverse direction perpendicular to the axial direction, or forms an angle between 0 and 15° with respect to the transverse direction.

4. The force sensor according to claim 1, characterized in that, the first section (10), the second section (20), and the intermediate section (30) each have a side wall surrounding a hollow portion, wherein the side wall of the intermediate section (30) is parallel to the side walls of the first section (10) and the second section (20).

5. The force sensor according to claim 1, characterized in that, the first section (10), the second section (20), and the intermediate section (30) each have an annular cross-section, wherein the outer diameter of the intermediate section (30) is less than the inner diameter of the first section (10) and less than the inner diameter of the second section (20); and the first section (10) and the second section (20) have the same inner diameter and outer diameter.

6. The force sensor according to claim 1, characterized in that, one of the first section (10) and the second section (20) is directly connected to the intermediate section (30), the other of the first section (10) and the second section (20) is connected to the intermediate section (30) through the annular portion.

7. The force sensor according to claim 1, characterized in that, The middle section (30) has a first recess (33), a second recess (34), and a central section (35) connecting the first recess (33) and the second recess (34). Both the first recess (33) and the second recess (34) are recessed relative to the outer surfaces of the first section (10), the second section (20), and the central section (35) to form two gaps (40). Wherein, the annular part includes a first annular part (41) and a second annular part (42). The first annular part (41) connects the first end (351) of the central section (35) and the first recess (33), and the second annular part (42) connects the second end (352) of the central section (35) and the second recess (34).

8. The force sensor according to claim 1, wherein The force sensor further includes an optical sensor component (200) extending axially through the first section (10) and the second section (20).

9. The force sensor according to claim 8, wherein The optical sensor component (200) includes: A plurality of reflection members (51) axially passing through the first section (10); and A plurality of optical fibers (52) axially passing through the second section (20) and having the same number as the reflection members (51); Wherein, one end of each reflection member (51) extends into the gap (40) and is opposite to the end of each optical fiber (52) extending into the gap (40).

10. The force sensor according to claim 1, wherein The width-to-thickness ratio (w / d) of the annular part is between 2 and 3.

11. The force sensor according to claim 1, wherein The sensor body (100) is an integral structure.

12. A force-sensing catheter, characterized in that, Comprising: A flexible and elongated body having a distal end; And The force sensor according to any one of claims 1-11, the force sensor being arranged at the distal end within the flexible and elongated body.

13. An ablation device, characterized in that, Comprising the force sensor according to any one of claims 1-11 or the force sensing catheter according to claim 12.

14. A medical device, characterized in that, Comprising the force sensor according to any one of claims 1-11 or the force sensing catheter according to claim 12.

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