JP4920770B2 - Surgical marker - Google Patents

Description

  The present invention relates to a marker for determining an excision line for excising a lesion site in, for example, breast-conserving surgery in breast cancer surgery, and more particularly to a surgical marker that can be confirmed with various diagnostic instruments (ultrasonic waves, MRI, CT, etc.).

The most prevalent breast-conserving surgery in breast cancer surgery requires a balance between curability and tolerability. Until now, in order to ensure the curability of breast-conserving surgery, a method of resecting the mammary gland 2 to 3 cm away from the outer edge of a lesion (tumor) confirmed by an imaging apparatus such as an ultrasonic diagnostic apparatus or MRI is generally used. Has been done.
The most common method for determining the resection range is to mark the outer edge of the tumor estimated by ultrasonography with magic on the skin immediately above, and draw a resection line on the skin 2 to 3 cm away from it. It is.
In the subcutaneous tissue and mammary gland, a viscous jelly (for example, xylocaine jelly) is mixed with a pigment (for example, picotanine, indigo carmine, etc.) to improve the tissue stagnation, and about 1 cm apart from the resection line skin. Type in a point while opening. This dye injection (injection) is performed using a chemical solution injection device (see, for example, Patent Document 1).

  However, in actual surgery, the excision line moves due to many factors, such as the diffusion of the marking dyes that are punctured into the spot, and the movement of the mammary gland due to body position change. It often happens that you can't decide. Furthermore, if the skin incision is to be kept as small as possible in order to maintain the post-surgery, the surgical field of view is limited, making it difficult to discriminate the resection line. Surgery with an incorrect resection line can cause lesions to be left behind and excessive resection, which can be a major disadvantage to the patient. In addition, when the resection is performed more than necessary, the breast is often deformed after the operation.

JP 2006-239260 A

  The present invention has been made in view of the above-described problems of the prior art, and its purpose is to determine an accurate resection line and confirm it with various diagnostic instruments (ultrasonic, MRI, CT, etc.). It is to provide a possible marker.

In order to achieve the above object, the surgical marker of the present invention is a surgical marker that is driven into a living tissue to determine a surgical region, and the marker is a line located at the center of the marker having a predetermined length. When the marker body is driven into the body within a predetermined range from the front end side to the rear end side inserted into the body of the marker body, the marker body moves in the insertion direction and the direction opposite to the insertion direction. a movement preventing portion of the brush form which prevent, characterized in that it comprises.
The marker body may be a single metal wire, or a single wire made by twisting a plurality of metal wires. The hardness of the wire constituting the marker body (or thickness) It is determined appropriately according to the driving method. For example, if the marker is inserted and set in the outer cylinder needle and driven, the marker is protected by the outer cylinder needle, and thus may be a thin wire material (for example, a thickness of 0.5 to 0.6 mm) that is slightly bent. In the case of a method of directly driving with a needle holder or the like, hardness (for example, thickness 1.0 to 1.6 mm) that maintains linearity is required.
The marker body may be a metal wire, a synthetic resin wire, or a composite wire in which the surface of the metal wire is covered with a resin material, and the material can be appropriately selected according to the diagnostic instrument, for example, , the case of forming the marker body with titanium wire, ultrasonic, MRI, that Do possible check at any of the diagnostic instrument of CT.
Further, the brush-shaped movement preventing member provided on the tip side (insertion side) of the marker body has, for example, short fibers of synthetic resin fibers radially projecting and integrated around the wire of the marker body. When it is inserted and set, it converges on the outer peripheral surface side of the marker body, and when it is pushed out from the outer cylinder needle and is left in the body, it expands radially outward from the outer peripheral surface of the marker body or bites into the body tissue, not good as long as they exhibit the anti-migration effect at stake and the organization.

According to the above means, the surgical marker is inserted and set into, for example, the outer cylinder needle, inserted vertically from the breast skin at the position where the outer cylinder needle is desired to be marked, and the marker tip is inserted into the breast from the tip of the outer cylinder needle at the target position. The marker can be placed by extruding and removing the outer cylinder needle. Then, in the living body, the movement prevention unit is released and entangled with the surrounding tissue to prevent the movement in the entering direction and the backward direction (the direction to exit), and the marker is fixed at the driving position. In addition, when the subcutaneous detachment is performed, since the marker is exposed on the subcutaneous tissue, it can be confirmed by visual observation, and an accurate excision line can be determined.
Further, even when the marker body is composed of a wire having a hardness that can maintain linearity and is held directly by a needle holder, the marker can be driven and placed at a predetermined position.

  The surgical marker of the present invention can be safely and surely driven at a target position, and after being driven, the movement preventing portion is entangled with surrounding tissues to prevent movement in the front-rear direction, and the marker is fixed at the driven position. Is done. Therefore, an accurate ablation line can be determined.

An example of embodiment of the surgical marker which concerns on this invention is shown, (a) is a front view, (b) is a top view. Explanatory drawing which shows the manufacturing process of the marker. (A)-(d) is explanatory drawing which shows the placement process of this marker. The perspective view of the fixing ring attached to this marker.

Hereinafter, embodiments of a surgical marker according to the present invention will be described with reference to the drawings.
FIG. 1 is a front view showing an example of a surgical marker. The surgical marker A is configured by integrally providing a movement preventing portion A2 on the distal end side of a wire-shaped marker main body A1.

The marker body A1 is a metal wire, for example, a titanium wire (φ 0.25 mm) 1 having a high biocompatibility and having a predetermined length is half-folded at a substantially central position, and the two half-folded titanium wires 1 are twisted. In addition, it is formed in a single piece (φ approximately 0.55 mm) to which linearity is imparted.
As shown in FIG. 2, the marker A has a predetermined range (about 20 mm from the front end side) by crossing the short fibers 2a of nylon fibers substantially perpendicular to the front end side of the two half-folded wires 1. The short fibers 2a are projected in a radial manner while drawing a spiral around the wire 1 by twisting the wire 1 and the movement preventing portion A2 of the brush form 2 is formed.

  Further, the tip of the short fiber 2 may be left cut, but both ends of the short fiber may be coated with a resin film. The coating of the resin film can be formed by immersing the tip of the short fiber in a resin solution in a state where the short fiber 2a is sandwiched between the half-folded wires 1.

Next, a description will be given of a mounting operation of the surgical marker A as placement marker for surgical resection line determination of mammary tumors in FIG. 3 (a) ~ (d) .
(1) First, before puncturing the marker, the marker placement position is determined.
(Under ultrasonic guide)
An ultrasonic examination is performed, and a necessary resection line is determined in consideration of preoperative mammography and MRI information. Then, 3 to 4 indwelling points are determined on the cutting line and marked with an oil pen.
(Under MRI guide)
Contrast-enhanced MRI examination is performed in the MRI examination room. The necessary resection range and indwelling point are determined from the MRI image, and the image is output to the film at the same magnification. Three to four indwelling points on the ablation line are projected onto the body surface through the film from directly above the body surface, and the indwelling points are marked on the skin with an oil pen.

(2) A marker is driven into the mammary gland and the post-mammary fat tissue vertically from above the mark indicating the indwelling point. Implantation of the marker, as shown in FIG. 3 (a), this marker A and insertion set out tube needle 8, the outer tube needle 8, woven fat after breast and mammary gland vertically from the top of the mark indicating the placement point 11 Insert inside. Then, as shown in (b), the push rod 9 is pushed from the rear end of the outer cylinder needle 8 at the target position to push the tip of the marker A into the breast from the needle tip of the outer cylinder needle 8, and the outer cylinder needle 8 is removed. Thus, the marker A is left in the tissue.
In the placement of the marker A, when the marker A is inserted and set in the outer cylinder needle 8, the movement preventing part A2 provided at the tip of the marker body A1 is folded and accommodated on the marker body A1 side by the peripheral wall of the outer cylinder needle 8. That is, the movement preventing portion A2 is when a brush 2 form, both side ends of the short fiber 2a is housed in the outer tube needle within 8 bent upward.
As described above, the movement preventing unit A2 accommodated by being folded in the outer cylindrical needle 8 is pushed out into the tissue from the outer cylindrical needle 8 and the outer cylindrical needle 8 is pulled out, so that the movement preventing unit A2 is contracted. The diameter is released, expands to a state before being inserted and set in the outer cylindrical needle 8, and is intertwined with the tissue, so that the marker A is fixed at the driving position.

It is possible to confirm the relative positional relationship between the lesion and the marker by performing MRI, CT, and ultrasonic examination after the insertion and placement. When correcting the position of the marker, the marker is inserted and placed at the newly determined position. A marker placed inadvertently can be removed by pulling it strongly.
When the marker main body A1 is a titanium wire, the position can be clearly confirmed by MRI even if the marker main body is a thin titanium wire. Also in the ultrasonic diagnostic apparatus, the marker made of titanium is diffusely reflected by the ultrasonic waves of the marker main body A1 and the movement preventing portion A2, so that visibility is secured and usefulness as a marker is obtained.

When the insertion and placement of the marker A are completed, a skin incision is performed as shown in FIG. In skin incision, the marker A is confirmed under direct vision while forming the flap 12 and dropped to the mammary gland.
Next, the mammary gland is excised along the marker A while actually touching the marker A under direct viewing. This excision work can also be used as an excision guide by performing the excision tool by applying it to the outer surface of the marker A (wire).
When a skin incision is made and the marker A is dropped to the mammary gland side, as shown in FIG. 4D, the marker body A1 (wire) of the marker A protruding from the mammary gland surface is fixed to the C type shown in FIG. The ring 10 can be fixed by caulking so that the marker A is not buried in the mammary gland. Furthermore, the presence confirmation of the marker A can be enhanced by the presence of the fixing ring 10 rather than a thin wire alone. Further, when the fixing ring 10 is colored, the visibility of the marker A can be further enhanced.
In addition to the use shown in FIG. 3 (d), the fixing ring 10 is fixed to the marker main body A1 protruding on the skin so as not to cause misalignment when the MRI inspection is performed after inserting the marker. 10 may be fixed. In that case, the skin is incised, and the marker body A1 protruding on the skin is cut off at the lower part of the fixing ring 10 before the flap 12 is raised.

The surgical marker according to the present invention is not limited to the illustrated embodiment, and can be appropriately changed without changing the gist of the present invention.
(1) In the embodiment, an example in which the marker body is formed of a titanium wire has been described. However, the present invention is not limited to this, and other metal wires such as a stainless wire may be used.
(2) In the embodiment, the example in which the marker main body of the marker having the brush-shaped movement prevention unit is formed by twisting two wires is not limited to this, but three or more wires are twisted. May be formed.
(3) In the embodiment, the method of driving the marker has been described with respect to the method using the outer cylinder needle. However, the present invention is not limited to this, and the surgical marker according to the present invention has a hardness that can maintain linearity, thereby It can also be used for a direct drive method.

A ... Marker for operation A1 ... Marker body A2 ... Movement prevention part 1, 3 ... Wire 2a ... Short fiber 2 ... Brush shape (movement prevention part)
8 ... Outer cylinder needle

Claims (2)

A surgical marker that is driven into a living tissue to determine a surgical region, the marker being a linear marker body located at the center of the marker having a predetermined length;
Brush that prevents the marker body from moving in the insertion direction and the direction opposite to the insertion direction when driven into the body within a predetermined range from the front end side to the rear end side of the marker body inserted into the body. A form of movement prevention unit;
Equipped with a,
The brush-shaped movement preventing portion is formed by integrally integrating short fibers of synthetic resin fibers radially around the marker body wire, and converges on the outer peripheral surface side of the marker body when being inserted and set in an outer cylinder needle. , bite radially outwardly from the outer peripheral surface of the marker body in expanded or body tissue when extruded from the outer tube needle is indwelled in the body, surgical marker characterized that you exert anti-migration effect.   The surgical marker according to claim 1, wherein the marker body is formed of titanium wire.

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