CN223350784U

CN223350784U - Force sensing guide wire

Info

Publication number: CN223350784U
Application number: CN202421366060.0U
Authority: CN
Inventors: 张立喆; 于美玲
Original assignee: Beijing Baiweishen Medical Technology Co ltd
Current assignee: Beijing Baiweishen Medical Technology Co ltd
Priority date: 2024-02-23
Filing date: 2024-06-14
Publication date: 2025-09-19
Anticipated expiration: 2034-06-14
Also published as: CN120532008A

Abstract

The present disclosure relates to a force sensing guidewire, comprising: a tubular member; a head cap connected to the tubular member; a hole disposed in the head cap and extending to the distal end of the head cap, wherein the angle between the extending direction of the hole and the axial direction of the head cap is less than 30 degrees; a pressure sensor disposed at the proximal end adjacent to the hole; and a flexible portion made of a gel or silicone material, disposed on the pressure sensor and extending within the hole to the distal end of the head cap. The force sensing guidewire disclosed herein can measure both blood pressure and the contact force between the force sensing guidewire and a tissue wall.

Description

Force sensing guide wire

Technical Field

The present disclosure relates to a force sensing guidewire.

Background

The force sensing guide wire can be used for minimally invasive interventional diagnosis and treatment of vascular and non-vascular channels. A force sensing guidewire is constructed with a sensor housing disposed between a middle portion and a distal portion, a pressure sensor disposed within the sensor housing, and a window disposed on the sensor housing for sensing an external pressure. However, the inventors have found that for such a solution, the contact force between the force sensing guidewire and the tissue wall cannot be monitored, which may result in injury to the vessel wall or organ wall when the force sensing guidewire hits the tissue wall.

Disclosure of Invention

It is therefore an object of the present disclosure to provide a force sensing guidewire that can measure both blood pressure and contact force with a tissue wall.

The above object is achieved by a force sensing guidewire according to the following.

The disclosure relates to a force sensing guidewire comprising a tubular member, a head cap connected to the tubular member, a bore disposed within the head cap and extending to a distal end of the head cap, the bore extending in a direction that is at an angle of less than 30 degrees to an axial direction of the head cap, a pressure sensor disposed adjacent a proximal end of the bore, and a flexible portion made of a gel or silicone material disposed on the pressure sensor and extending within the bore to the distal end of the head cap.

In one embodiment, a proximal end of the bore is located within the head end cap, which includes a proximal end wall.

In one embodiment, an optical fiber connected to the pressure sensor extends through a proximal end wall of the head end cap toward the tubular member.

In one embodiment, the bore extends in an axial direction of the head end cap to a distal end of the head end cap.

In one embodiment, the aperture comprises a through hole through the head end cap.

In one embodiment, a support member for securing the pressure sensor is further included, the support member being located within the bore or within the tubular member.

In one embodiment, the distal portion of the tubular member includes a developer spring connected to the head end cap, and a head end core wire nested in the developer spring.

In one embodiment, the bore diameter of the bore increases in a direction extending toward the distal end of the head end cap.

In one embodiment, the pressure sensor is disposed within the bore.

In one embodiment, the pressure sensor further comprises an optical fiber which extends in the tubular member, the pressure sensor is arranged at the end part of the optical fiber, a Bragg grating for measuring the bending direction of the force feedback guide wire is arranged on the optical fiber, and a sensing piece is arranged on one side of the Bragg grating.

The present disclosure also provides a method of making a force sensing guidewire comprising perforating a bore in a head cap, the bore extending to a distal end of the head cap, securing a pressure sensor adjacent a proximal end of the bore, filling a liquid silicone or gel into the bore, and heat curing to form a flexible portion, the flexible portion extending to the distal end of the head cap.

The present disclosure has the advantage that the blood pressure or the contact force of the force sensing guidewire with the tissue wall can be transferred to the pressure sensor via the flexible portion, and the force sensing guidewire can measure both the blood pressure and the contact force between the force sensing guidewire and the tissue wall. When the force sensing guide wire is in contact with the tissue wall, the contact force applied to the head end of the force sensing guide wire can be transferred to the pressure sensor through the flexible part, so that the contact force applied to the force sensing guide wire is measured, medical equipment does not need to be replaced, and the operation is convenient.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings of the embodiments of the present disclosure will be briefly described below. Wherein the drawings are designed solely to illustrate some embodiments of the disclosure and not to limit all embodiments of the disclosure thereto. In the accompanying drawings:

FIG. 1 illustrates a schematic structural view of a force sensing guidewire according to one embodiment of the present disclosure;

Fig. 2 illustrates a schematic structural view of a force sensing guidewire according to another embodiment of the present disclosure.

1-Tubular member 12-distal end portion 121-developing spring 122-head core wire 2-head end cap 21-proximal end wall 22 of head end cap-distal end 23 of head end cap-proximal end 4 of axial 3-bore 31-bore of head end cap-pressure sensor 5-flexible portion 6-support part 7-optical fiber 8-channel

Detailed Description

In order to make the objects, technical solutions and advantages of the technical solutions of the present disclosure more clear, the technical solutions of the embodiments of the present disclosure will be clearly and completely described below with reference to the accompanying drawings of specific embodiments of the present disclosure. Like reference numerals in the drawings denote like parts. It should be noted that the described embodiments are some, but not all embodiments of the present disclosure. All other embodiments, which can be made by one of ordinary skill in the art without the need for inventive faculty, are within the scope of the present disclosure, based on the described embodiments of the present disclosure.

Unless defined otherwise, technical or scientific terms used herein should be given the ordinary meaning as understood by one of ordinary skill in the art to which this disclosure belongs. The terms "first," "second," and the like in the description and in the claims, do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. Likewise, the terms "a" or "an" and the like do not necessarily denote a limitation of quantity. The word "comprising," "comprising," or "having" and the like means that elements or items preceding the word are meant to be encompassed by the element or item recited following the word and equivalents thereof, without excluding other elements or items. The terms "connected" or "connected" and the like are not limited to the physical or mechanical connection or communication shown in the drawings, but may include connection or communication equivalent thereto, whether direct or indirect. "upper", "lower", "left", "right", etc. are used merely to indicate relative positional relationships, which may also be changed when the absolute position of the object to be described is changed.

In some medical interventions it is desirable to monitor intravascular blood pressure. For example, some medical devices may include pressure sensors that allow a clinician to monitor blood pressure. Such a device may be used to determine fractional flow reserve, which may be understood as the ratio of the pressure after stenosis relative to the pressure before stenosis. The inventors of the present disclosure found that the medical device monitors only the blood pressure, cannot monitor the contact force with the blood vessel wall, and that the medical device may cause damage to the blood vessel wall or the organ wall when colliding with the blood vessel wall, and cause a problem of inconvenient operation.

Embodiments of a force sensing guidewire according to the present disclosure are described in detail below with reference to fig. 1-2.

In one embodiment of the present disclosure, a force sensing guidewire includes a tubular member 1, a head end cap 2 coupled to the tubular member 1, a bore 3 disposed within the head end cap 2 and extending to a distal end 22 of the head end cap, the bore 3 extending in a direction that forms an angle of less than 30 degrees with an axial direction 23 of the head end cap, a pressure sensor 4 disposed adjacent a proximal end 31 of the bore, and a flexible portion 5 made of a gel or silicone-type material disposed on the pressure sensor 4 and extending within the bore 3 to the distal end 22 of the head end cap.

A flexible portion 5 made of gel or a silicone-like material is provided on the pressure sensor 4, and blood pressure or contact force with the tissue wall can be transmitted to the pressure sensor 4 through the flexible portion 5, and the pressure sensor 4 can sense the force and transmit the signal to a display or monitoring device (not shown). When the force sensing guide wire is contacted with the tissue wall, the contact force applied to the head end of the force sensing guide wire can be transferred to the pressure sensor through the flexible part, so that the contact force applied to the force sensing guide wire can be measured, and the blood pressure can be sensed, the contact force with the tissue wall can be sensed, medical equipment is not required to be replaced, and the operation is convenient.

The tubular member 1 is not limited in material and may be made of stainless steel, such as medical 304v stainless steel. The length of the tubular member is not limited, and may be 1800mm, for example, the outer diameter may be not more than 0.36mm, for example, 0.355mm, and the inner diameter may be between 0.13mm and 0.18 mm.

The tubular member 1 may be integrally formed of the same material, or may be welded by two or more segments. In some embodiments, the tubular member 1 includes a proximal portion, which is an elongated tubular structure, and a distal portion 12 through which an operator manipulates a force sensing guidewire to travel along a vascular or non-vascular lumen of a human body during a procedure, partially outside the body. The distal end portion 12 of the tubular member 1 includes a developer spring 121 and a head end core wire 122 nested within the developer spring 121. The distal end portion and the proximal end portion may be connected by a connector having a cylindrical structure with both ends thereof being thin and thick at the middle, one end of which is inserted into the developing spring and the other end of which is inserted into the proximal end portion. The head end core wire 122 may be secured to the connector.

The outer diameter of the head cap 2 is substantially the same as the outer diameter of the tubular member 1 and may be no more than 0.36mm, for example 0.355mm. The length of the head cap may be 1.5mm-3mm, for example 2mm. The material of the head end cap is not limited and may be stainless steel, such as medical 304v stainless steel.

The aperture 3 is disposed within the head end cap 2 and extends to a distal end 22 of the head end cap, the location of the aperture 3 within the head end cap 2 is not limited, and in some embodiments, the center of the aperture 3 is adjacent the axial center of the head end cap 2. The hole 3 is a bar-shaped hole along the extending direction, and the cross-sectional shape of the hole 3 may include a circle, but may also include, but is not limited to, a polygon, a cross-shape, and the like. The pore diameter of the pores 3 may be the same or different at different positions in the direction of extension. In some embodiments, the bore diameter of the bore 3 increases gradually in the direction of extension to the distal end 23 of the head cap to increase the force sensing sensitivity of the force sensing guidewire.

The direction of extension of the bore 3 is less than 30 degrees from the axial direction 23 of the head cap, and in some embodiments, the bore 3 extends along the axial direction 23 of the head cap to the distal end 22 of the head cap to lift the sensitivity of the force sensing guidewire to axial forces in contact with the tissue wall.

In some embodiments, the proximal end 31 of the bore is located within the head end cap 2, the length of the bore 3 being less than the length of the head end cap 2, the head end cap including a proximal end wall 21 located at the proximal end 31 of the bore. The pressure sensor 4 can be arranged on the proximal end wall 21, avoiding the risk of the pressure sensor falling off, and improving the sensing sensitivity. The length of the hole is not limited and may be, for example, 1mm to 1.5mm. In some embodiments, a channel 8 may be provided in the proximal end wall 21 of the head end cap for passage of the optical fiber 7, the optical fiber 7 being connected to the pressure sensor 4 and extending through the channel 8 towards the tubular member 1. The aperture of the channel 8 is larger than the outer diameter of the optical fiber. In some embodiments, the aperture 3 is a through-hole that extends through the head end cap 2 in the axial direction 23 of the head end cap, the length of the aperture 3 being approximately equal to the length of the head end cap 2. A dispensing hole for dispensing the adhesive of the adhesive pressure sensor 4 can be formed in the side wall of the head end cap 2. The ends of the head end core wire 122 may be positioned in the channel 8 to prevent the head end core wire from touching the tissue wall.

In some embodiments, the holes 3 are through holes that extend through the head end cap 2 in the axial direction 23 of the head end cap. The pressure sensor 4 may be provided in the bore 3 or may be provided wholly or partly in the tubular member 1. The pressure sensor 4 may be fixed to the side wall of the hole 3 or to the support member 6 by, but not limited to, adhesion, welding, clamping, etc. The sum of the lengths of the pressure sensor 4 and the flexible portion 5 may be smaller than the length of the head end cap 2, or may be greater than or equal to the length of the head end cap. The support member 6 for supporting the pressure sensor 4 may be provided in the tubular member 1 or the hole 3, and the material of the support member 6 is not limited, and may include, for example, stainless steel, and the support member 6 may be fixed to the tubular member 1 or the hole 3 by, for example, bonding, welding, or the like. The ends of the head end core wire 122 may be positioned in the holes 3 to prevent the head end core wire from touching the tissue wall.

In some embodiments, the pressure sensor 4 is disposed in the hole 3, the lengths of the flexible portion 5 and the pressure sensor 4 are not limited, and the sum of the lengths of the flexible portion 5 and the pressure sensor 4 is not greater than the length of the hole 3, so that the pressure sensor can be prevented from being collided with the outside, and the risk of falling off the pressure sensor is reduced. The length of the pressure sensor may be no greater than 0.3mm. The manner in which the pressure sensor 4 is secured within the bore 3 is not limited and, for example, the pressure sensor 4 may be secured to the proximal end wall 21 of the head end cap, or to the side wall of the bore 3, or to the support member 6.

The pressure sensor 4 may comprise a semiconductor (e.g., silicon wafer) pressure sensor, a piezo-electric pressure sensor, an optical fiber or optical pressure sensor, a fabry-perot pressure sensor, an ultrasonic transducer and/or an ultrasonic pressure sensor, a magnetic pressure sensor, a solid state pressure sensor, etc., or any other suitable pressure sensor. In some embodiments, a flexible portion is provided on the pressure sensing face of the pressure sensor, the face of the pressure sensor opposite the pressure sensing face being connected to an optical fiber 7, the optical fiber 7 extending into the tubular member 1.

The flexible portion 5 extending within the bore 3 to the distal end 22 of the head end cap is defined as the flexible portion 5 being flush with the end face of the distal end 22 of the head end cap, or the flexible portion 5 being slightly higher than the end face of the distal end 22 of the head end cap, such that the force applied to the head end cap 2 is transferred through the flexible portion to the pressure sensor 4, the pressure sensor 4 changing in response to a change in the force applied to the head end cap 2. The pressure sensor 4 and the flexible portion 5 may be integrally formed or separately provided. The flexible portion may be formed by filling liquid silica gel or gel into the hole 3 in which the pressure sensor 4 is fixed, and heat curing. The outer diameter of the flexible portion 5 is approximately equal to the aperture of the hole 3.

The aperture of the hole 3 at the location where the pressure sensor 4 is accommodated may be the same as or different from the aperture at the location where the flexible portion 5 is accommodated. In some embodiments, the aperture of the site accommodating the pressure sensor 4 is larger than the aperture of the site accommodating the flexible portion 5. The aperture of the portion accommodating the pressure sensor 4 is slightly larger than the outer diameter of the pressure sensor 4 to place the pressure sensor. For example, the aperture of the portion accommodating the flexible portion 5 may be 0.1mm to 0.3mm, for example, about 0.25mm, and the aperture of the portion accommodating the pressure sensor 4 may be more than 0.26mm.

In one embodiment, the force feedback guide wire further comprises an optical fiber which extends in the tubular member, the pressure sensor is arranged at the end of the optical fiber, a Bragg grating for measuring the bending direction of the force feedback guide wire is arranged on the optical fiber, and a sensing piece is arranged on one side of the Bragg grating.

The length of the Bragg grating is not limited, and may be, for example, 1mm, 2mm, or 5mm. The material and shape of the sensing sheet are not limited, and the sensing sheet may include a metal sheet such as an aluminum sheet. The sensing piece can be arranged on one side of the Bragg grating in a sticking mode or the like. The length of the sensing piece can be equal to the length of the grating region of the Bragg grating, the length of the sensing piece can be set to be 0.5-1.5 times of the length of the grating region of the Bragg grating, and the width of the sensing piece can be not smaller than the diameter of the optical fiber. When the force sensing guide wire bends towards the direction of the sensing piece, the fiber bragg grating is compressed, the central wavelength of the output of the corresponding bragg grating is reduced, when the fiber bragg grating is bent back to the sensing piece, the central wavelength of the output of the corresponding bragg grating is increased, therefore, the bending direction of the force feedback guide wire can be measured, the judgment of the bending direction of the force sensing guide wire can be realized, and meanwhile, the pressure sensor arranged at the end part of the optical fiber can measure the blood pressure or the contact force of the force feedback guide wire and the tissue wall.

The disclosure provides a method of making a force sensing guidewire comprising perforating a head end cap with an aperture extending to a distal end of the head end cap, securing a pressure sensor adjacent a proximal end of the aperture, filling a liquid silicone or gel into the aperture, and heat curing to form a flexible portion extending to the distal end of the head end cap. The force sensing guide wire prepared by the method can sense blood pressure and contact force between the force sensing guide wire and a tissue wall, and meanwhile, medical equipment does not need to be replaced, so that the operation is convenient.

Furthermore, each feature disclosed above is not limited to the combination of the disclosed features with other features, and other combinations between features may be made by those skilled in the art in view of the disclosure for the purpose of this disclosure.

Claims

1. A force sensing guidewire, comprising:

a tubular member;

A head end cap connected to the tubular member;

The hole is arranged in the head end cap and extends to the distal end of the head end cap, and an included angle between the extending direction of the hole and the axial direction of the head end cap is smaller than 30 degrees;

a pressure sensor disposed adjacent a proximal end of the bore;

A flexible portion made of a gel or silicone material disposed on the pressure sensor and extending within the bore to a distal end of the head end cap.

2. The force sensing guidewire of claim 1, wherein a proximal end of the bore is located within the head end cap, the head end cap including a proximal end wall.

3. The force sensing guidewire of claim 2, wherein an optical fiber connected to the pressure sensor extends through a proximal end wall of the head end cap toward the tubular member.

4. The force sensing guidewire of claim 1, wherein the bore extends axially of the head cap to a distal end of the head cap.

5. The force sensing guidewire of claim 1, wherein the aperture comprises a through-hole through the head end cap.

6. The force sensing guidewire of claim 5, further comprising a support component for securing the pressure sensor, the support component being located within the bore or within the tubular member.

7. The force sensing guidewire of claim 1, wherein the tubular member comprises a developing spring coupled to the head end cap, and a head end core wire nested in the developing spring.

8. The force sensing guidewire of claim 1, wherein the bore diameter of the bore increases in a direction extending toward the distal end of the head end cap.

9. The force sensing guidewire of claim 1, wherein the pressure sensor is disposed within the bore.

10. The force sensing guidewire of claim 1, wherein the force sensing guidewire comprises a plurality of guide wires,

The pressure sensor is arranged at the end part of the optical fiber, the optical fiber is provided with a Bragg grating for measuring the bending direction of the force sensing guide wire, and one side of the Bragg grating is provided with an induction piece.