Guide wire

Abstract

This invention provides a guidewire that enables smooth access to the lesion by imaging the surrounding tissues of the body cavity. [Solution] A guide wire comprising: a long guide wire body having a defined longitudinal direction and a tip; and a light guide portion extending longitudinally within the guide wire body, the light guide portion having a light transmitting / receiving unit at the tip of the guide wire body that transmits light to the tip side in the longitudinal direction and receives reflected light from an object to be observed, the reflected light being used to generate an image of the object to be observed.

Description

Technical Field

[0001] This disclosure relates to a guide wire.

Background Art

[0002] For example, in percutaneous coronary intervention (PCI), after a guide wire is introduced into the body cavity and reaches the lesion, a diagnostic or therapeutic catheter is made to reach the lesion using the guide wire (see, for example, Patent Document 1).

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] A guide wire is usually used relying on contrast images. However, it is difficult to determine from the contrast images where the guide wire is located in the body cavity and whether the guide wire contacts or penetrates the peripheral tissues of the body cavity such as the blood vessel wall. Therefore, for example, the guide wire may enter an unintended location called a false lumen in a lesion in the blood vessel, enter a blood vessel that is not a lesion, or perforate the blood vessel with the guide wire. These situations may lead to an extension of the treatment time.

[0005] Therefore, an object of this disclosure is to provide a guide wire that can achieve smooth access to a lesion by imaging the peripheral tissues of the body cavity.

Means for Solving the Problems

[0006] One aspect of this disclosure is as follows.

[0007] [1] A long guide wire body that defines the longitudinal direction and has a tip, A guide wire having a light guide portion that extends longitudinally inside the guide wire body, the light guide portion having a light transmitting / receiving unit at the tip of the guide wire body that transmits light to the tip side in the longitudinal direction and receives reflected light from an object to be observed, and the reflected light is used to generate an image of the object to be observed.

[0008] [2] The guide wire according to [1], wherein the tip of the guide wire body has a covering member that forms part of the light transmission and reception path between the light transmission and reception unit and the object to be observed and covers the light transmission and reception unit.

[0009] [3] The cover member is a light-transmitting material that constitutes a part of the optical transmission and reception path, as described in [2], the guide wire.

[0010] [4] The light-transmitting material is a guide wire as described in [3], which fills the space between the light transmitting / receiving unit and the light-emitting surface.

[0011] [5] The light-transmitting material is composed of an adhesive, as described in [3] or [4], for the guide wire.

[0012] [6] The covering member is a guide wire according to any one of [2] to [5], having a housing with an opening through which the optical transmission and reception path passes.

[0013] [7] The guide wire described in [6], wherein the housing is made of metal.

[0014] [8] A guide wire as described in any one of items [1] to [7], A guide wire set comprising a calibration device that contacts the tip of the guide wire body and reflects the light from the light transmitting and receiving unit.

[0015] [9] A guide wire according to any one of [1] to [7], and an image generation device that generates the image based on the reflected light. An image generation system.

Effect of the Invention

[0016] According to the present disclosure, it is possible to provide a guide wire that can realize smooth access to a lesion by imaging the peripheral tissue of a body cavity.

Brief Description of the Drawings

[0017] [Figure 1] It is a schematic diagram of an image generation system according to an embodiment of the present disclosure. [Figure 2] It is a side view with an enlarged tip portion of the guide wire shown in FIG. 1. [Figure 3] It is a side view showing a modification of the tip portion of the guide wire shown in FIG. 2. [Figure 4] It is a partially sectional side view showing a state of calibrating the guide wire shown in FIG. 1. [Figure 5] It is a partially sectional side view showing a state during use of the guide wire shown in FIG. 1. [Figure 6] It is a cross-sectional view taken along line A-A of FIG. 1. [Figure 7] It is a partially sectional side view with an enlarged tip portion of the guide wire shown in FIG. 6. [Figure 8] It is a partially sectional side view showing a state when the tip portion of the guide wire has entered the false lumen of a blood vessel from the state shown in FIG. 7. [Figure 9] It is a schematic diagram showing an example of an image obtained by the image generation system shown in FIG. 1.

Mode for Carrying Out the Invention

[0018] Hereinafter, embodiments of the present disclosure will be described in detail with reference to the drawings.

[0019] As shown in Figure 1, an image generation system 1 according to one embodiment of the present disclosure includes a guide wire 2, an image generation device 3 connected to the proximal end of the guide wire 2, and a display 4 connected to the image generation device 3. The guide wire 2 is introduced into a body cavity (such as the lumen of a blood vessel, such as a coronary artery) of a human or other body in accordance with a surgical procedure such as PCI, and moves within the body cavity according to the operator's operation until the tip portion 2a of the guide wire 2 reaches the lesion. As shown in Figure 6, the tip portion 2a of the guide wire 2 has a curved shape that is radially outward toward the longitudinal tip side, making it easier to select a path toward the target site at a branching point of the body cavity. In this embodiment, the guide wire 2 is described as advancing within a blood vessel as an example, but is not limited to this, and may be used for body cavities other than the lumen of a blood vessel.

[0020] As shown in Figure 2, the guidewire 2 comprises a long guidewire body 5 that defines the longitudinal direction and has a tip, and a light guide section 6 that extends longitudinally inside the guidewire body 5, and has an optical transmitting / receiving unit 6a at the tip of the guidewire body 5 that transmits light 7 to the tip side in the longitudinal direction and receives reflected light from the object being observed, and the reflected light is used to generate an image of the object being observed. The guidewire body 5 (guidewire 2) has a central axis O and extends longitudinally along the central axis O. The optical transmitting / receiving unit 6a transmits light 7 so that the optical axis is aligned with the central axis O. In this embodiment, when the guidewire 2 is introduced into a body cavity, the side closer to the operator in the longitudinal direction is called the proximal end, and the opposite side is called the proximal end. The direction perpendicular to the central axis O is called the radial direction, and the direction that circles the central axis O is called the circumferential direction.

[0021] As shown in Figure 2, the guide wire body 5 has a hollow shaft 5a that extends longitudinally and a covering member 5b provided at the tip of the guide wire body 5 and connected to the tip of the shaft 5a. The covering member 5b forms part of the light transmission and reception path between the light transmission and reception unit 6a and the object of observation and covers the light transmission and reception unit 6a. The covering member 5b has a metal housing 5b1 connected to the tip of the shaft 5a and a light-transmitting material 5b2 held in the housing 5b1 and constituting part of the light transmission and reception path. The light-transmitting material 5b2 is made of adhesive and fills the space between the light transmission and reception unit 6a and the emission surface from which light 7 is emitted. In this embodiment, the housing 5b1 is provided on the base end side of the light transmission and reception path, but it is not limited to this, and may have an opening 5b3 through which the light transmission and reception path passes, as shown in the modified example in Figure 3.

[0022] The shaft 5a is preferably in the shape of a coil. In this case, the shaft 5a may be made of a spiral wire centered on the central axis O. The shaft 5a may be made of a single wire wound in one strand, or it may be made of multiple strands wound in parallel spirals with two or more wires placed adjacent to each other in the longitudinal direction, or it may be a multi-layered configuration with two or more spiral wires arranged in the radial direction.

[0023] The image generation device 3 includes a light-emitting unit 3a, a light-receiving unit 3b, a reference light-forming unit 3c, an optical connection unit 3d, and an image generation unit 3e. The optical connection unit 3d is connected to the base end of the light-guiding unit 6 of the guide wire 2. The light-emitting unit 3a emits light 7, which enters the base end of the light-guiding unit 6 via the optical connection unit 3d. The light-guiding unit 6 transmits the light 7 that entered the base end of the light-guiding unit 6 to the light-transmitting / receiving unit 6a located at the tip of the light-guiding unit 6, and then emits (transmits) the light from the light-transmitting / receiving unit 6a towards the longitudinal tip. The light 7 emitted from the light-transmitting / receiving unit 6a penetrates bodily fluids, tissues, etc., and is reflected by the substance to be observed at various positions along its path, returning to the light-transmitting / receiving unit 6a. The light 7 that entered the light-transmitting / receiving unit 6a is transmitted to the base end of the light-guiding unit 6 and is received by the light-receiving unit 3b of the image generation device 3 via the optical connection unit 3d. As shown in Figure 2, the light guide unit 6 is composed of an optical fiber 6c having a lens 6b at its tip. The light transmitting and receiving unit 6a is composed of the lens 6b. The wavelength of the light 7 transmitted and received by the light transmitting and receiving unit 6a is not particularly limited, but it is preferably near-infrared light.

[0024] The reference light forming unit 3c separates a portion of the light 7 traveling from the light emitting unit 3a to the optical connection unit 3d as reference light and returns it to the light receiving unit 3b. The reference light forming unit 3c is composed of, for example, a beam splitter and a reflector. The image generating unit 3e images the object to be observed along the propagation path by interfering the light 7 from the light guiding unit 6, which is received by the light receiving unit 3b, with the reference light received by the light receiving unit 3b. In other words, the image generating device 3 generates an image by OCT (Optical Coherence Tomography). For OCT, for example, TD-OCT (Time-Domain OCT) or FD-OCT (Fourier-Domain OCT) can be used. For FD-OC, SD-OCT (Frequency Scanning OCT) or SS-OCT (Spectral-Domain OCT) can be used.

[0025] In order to generate an image using OCT, calibration is required to match the optical path length of the reference light with the optical path length of the optical transmission / reception path from the optical transmission / reception unit 6a. In this embodiment, a calibration tool 8 as shown in Figure 4 is used for calibration. The calibration tool 8 contacts the tip of the guide wire body 5 and reflects the light 7 from the optical transmission / reception unit 6a. For this purpose, the calibration tool 8 has a retaining groove 8a that holds the tip portion 2a of the guide wire 2 by fitting. The retaining groove 8a has a pair of groove side wall surfaces 8a1 that contact a pair of side surfaces of the tip portion 2a of the guide wire 2, a groove bottom surface 8a2 that contacts the bottom surface of the tip portion 2a of the guide wire 2, and a groove tip surface 8a3 that contacts the tip of the tip portion 2a of the guide wire 2 (the tip of the guide wire body 5). In this embodiment, the retaining groove 8a is configured as a U-shaped groove having a pair of groove side walls 8a1 and a groove bottom surface 8a2. However, it is not limited to this configuration; for example, it may be configured as a V-shaped groove that contacts a pair of sides of the tip portion 2a of the guide wire 2 but does not contact the bottom surface of the tip portion 2a of the guide wire 2. The calibration device 8 allows the optical path length of the optical transmission / reception path from the optical transmission / reception unit 6a during calibration to be matched to a known distance between the tip of the optical transmission / reception unit 6a and the tip of the guide wire body 5, thereby enabling smooth calibration. The guide wire 2 and the calibration device 8 constitute a guide wire set 9. The calibration device 8 may be integrally provided with a guide wire holder that holds unused guide wires 2. In this case, the retaining groove 8a is provided at an appropriate location on the guide wire holder.

[0026] The image generated from the light 7 transmitted and received at a predetermined timing (instantaneous) is in the shape of a strip, having coordinate axes representing the coordinates on the path of the light 7 emitted from the light transmitting and receiving unit 6a, and the intensity of the reflected light from the object of observation at each coordinate is represented by brightness. An example is shown in Figure 9. The image generation unit 3e generates a display image for display on the display 4 based on the strip-shaped image. The format of the display image is not particularly limited, and may be an image format in a Cartesian coordinate system with the vertical axis representing the coordinates on the path of the light and the horizontal axis representing time, or a fan-shaped or circular image format formed by rotating the strip-shaped image around one end of the image.

[0027] As shown in Figures 5-6, the blood vessel wall 10 has the intima 10a, media 10b, and adventitia 10c in that order from the inside to the outside, forming a true lumen 10d inside the intima 10a. The blood vessel wall 10 may separate from the media 10b due to a crack in the intima 10a caused by an increase in blood pressure, etc., which causes blood to leak and create a false lumen 10e between the intima 10a and media 10b. If the guidewire 2 is not manipulated properly when advancing it toward the lesion to be treated, the tip portion 2a of the guidewire 2 may penetrate the intima 10a and enter the false lumen 10e, or even pierce the media 10b and adventitia 10c and protrude to the outside of the blood vessel.

[0028] According to this embodiment, the optical transmitting and receiving unit 6a provided on the guidewire 2 allows the guidewire 2 to be advanced within the body cavity while the peripheral portion of the tip 2a of the guidewire 2 in the longitudinal direction is imaged and observed. For example, as shown in Figure 7, when the guidewire 2, which is advancing within the true lumen 10d, penetrates the intima 10a and enters the false lumen 10e, as shown in Figure 8, the portion representing the intima 10a disappears from the display image seen by the operator, allowing them to recognize this situation. Therefore, smooth access to the lesion can be achieved.

[0029] While embodiments of this disclosure have been described above, this disclosure is not limited to the embodiments described above, and the embodiments described above can be modified in various ways without departing from the gist of this disclosure. [Explanation of Symbols]

[0030] 1. Image generation system 2 Guide wires 2a Tip part 3. Image generation device 3a Light-emitting part 3b Light receiving section 3c Reference beam forming section 3D optical connection section 3e Image generation unit 4 displays 5 Guide wire body 5a shaft 5b Covering member 5b1 Housing 5b2 Translucent material 5b3 opening 6. Light guide section 6a Optical Transceiver Unit 6b lens 6c optical fiber 7 light 8 Calibration tools 8a Retaining groove 8a1 Ditch side wall 8a2 groove bottom 8a3 Groove tip surface 9 Guide wire set 10 Blood vessel wall 10a Intima 10b Media 10c adventitia 10d true lumen 10e false lumen O center axis

Claims

1. A long guide wire body that defines the longitudinal direction and has a tip, A guide wire having a light guide portion that extends longitudinally inside the guide wire body, the light guide portion having a light transmitting / receiving unit at the tip of the guide wire body that transmits light to the tip side in the longitudinal direction and receives reflected light from an object to be observed, and the reflected light is used to generate an image of the object to be observed.

2. The guide wire according to claim 1, wherein the tip of the guide wire body has a covering member that forms part of the light transmission / reception path between the light transmission / reception unit and the object to be observed and covers the light transmission / reception unit.

3. The guide wire according to claim 2, wherein the covering member has a light-transmitting material that constitutes a part of the light transmission and reception path.

4. The light-transmitting material fills the space between the light transmitting / receiving unit and the light-emitting surface, as described in claim 3.

5. The guide wire according to claim 3, wherein the light-transmitting material is made of an adhesive.

6. The guide wire according to claim 2, wherein the covering member has a housing having an opening through which the optical transmission and reception path passes.

7. The guide wire according to claim 6, wherein the housing is made of metal.

8. The guide wire according to claim 1, A guide wire set comprising a calibration device that contacts the tip of the guide wire body and reflects the light from the light transmitting and receiving unit.

9. The guide wire according to claim 1, An image generation system comprising an image generation device that generates the image based on the reflected light.

Images