JP5361430B2 - Ablation area marker instrument - Google Patents

Description

The present invention relates to an excision region marker instrument that is installed around a lesion and serves as an index of excision region during partial mammary resection.

  With the development of diagnostic imaging equipment, it is possible to accurately grasp the spread of breast cancer, etc. before surgery, and it is determined that breast-conserving surgery can be applied for invasive or non-invasive cancers up to 3 cm in size. For selected cases, partial resection of the breast is selected. In this partial resection of the breast, the lesion is identified by an image diagnostic apparatus (ultrasound diagnostic apparatus, MRI, multi-slice CT, etc.) before the operation, and the resection range including the lesion is designed (usually around the lesion). In the case of surgery, prior to excision of the lesion, a marker device that can be depicted on the diagnostic imaging apparatus is placed inside the boundary of the planned excision area set around the lesion, One or more holes should be perforated so as to surround or to clearly recognize the boundary for excision, and the positional relationship between the marker device and the lesion is confirmed by an image diagnostic device and prepared. In this method, the skin and subcutaneous tissue are cut off (skin flap formation), and the boundary of the planned resection area outside the marker device is cut off including the marker device while checking the marker device by palpation and visual observation. Sampling It has been.

And, as a conventional marker device applicable to this partial mammary gland excision, it is inserted into the excision region boundary through a hollow outer tube, and a shape that can be placed in the tissue such as a J shape inserted into the tissue The wire (for example, patent document 1) which forms, and the instrument (patent document 2) etc. which include the helical screw tip formed in the shape of a conch shell are proposed. However, with these instruments, the wire or the like may be slightly displaced from the position where the patient is moved (body movement) due to the deformation of the wire or the weak contact with the tissue. It has been pointed out that the image is not enough.
Therefore, as a tool for solving these drawbacks, a wire comprising a cannula (outer tube) and a marking device, the marking device including a helical coil having a blade tip at the tip and a constant width of the spiral portion. In order to puncture the lesion, the lesion sighting device is proposed in which the marking device is slid in the axial direction through the cannula and rotated in conformity with the spiral to be inserted. (Patent Document 3)
According to this apparatus, since the width of the spiral portion is constant, once the spiral marker is drilled in the lesion portion, the tissue does not bite into the tissue and the position does not shift. The shape wound in a shape is clearly depicted by the diagnostic imaging apparatus, thereby solving the conventional problem.

JP-T 62-502244 JP-T-1-503447 Japanese National Patent Publication No. 4-506164

However, according to the instrument of Patent Document 3, when placing the helical coil serving as the marker portion of the marking device in the tissue, the cannula is first punctured and the marking device is drilled through the cannula lumen. On the other hand, considering the puncture wound to the skin that is not excised by surgery, the outer diameter of the cannula should be about 5 mm at the maximum (the wound becomes too large if it exceeds that), The outer diameter of the width of the helical coil to be inserted (in the above-mentioned document, the shaft outer diameter is 0.04 cm and the helical wire diameter is 0.02 cm, which is calculated from the description) is limited. Since the wire including the coil becomes a thin and delicate instrument, handling such as rotating operation during puncture is not necessarily good. In addition, because of the small size, there is a concern that it is difficult to find as an index when the ablation area is excised by tactile sensation or visual inspection with the help of a marker. There is a concern that it is not always clear due to the small size.
In addition, small-sized edge cutting and spiral processing require a certain level of precision, which can be cumbersome to manufacture.

  Therefore, the present invention increases the burden on the human body in addition to the fact that there is no detachment or misalignment of the instrument from the installation position after the marker portion has been drilled into the tissue, and the imaging on the diagnostic imaging apparatus is clear. Therefore, it is an object of the present invention to provide an excision region marker device that is easy to use and easy to manufacture, such as being easy to puncture into a tissue and having excellent recognition as an index.

The excision region marker instrument of the present invention comprises a puncture needle having a cutting edge at the tip, a predetermined length spirally from the tip, and a base side formed in a straight line, and a gripping portion provided at the base of the puncture needle The width of the spiral portion is substantially constant, and the linear portion extends substantially along the central axis of the spiral, and a guide device such as an outer tube is used to puncture tissue from the skin surface. The puncture needle can be independently punctured while rotating without being used .

  Further, the puncture needle was formed with an outer diameter of 0.6 mm or more and 1.8 mm or less, and a spiral part width of 4 mm or more and 18 mm or less.

  Further, in addition to the marker device, a plate-like plate for regulating the puncture depth of the puncture needle may be provided.

(Function)
According to this means, a marker instrument such as an outer tube is not required, and a guide device for drilling is not required, and the marker device itself can be punctured, so that the size of the marker device is limited by the size of the outer tube. However, the size of the marker device can be sturdily formed in a desired size optimum for the corresponding operation such as partial resection of the breast.
In addition, the spiral width of the marker portion can be formed to have a larger diameter than the conventional one, and since the width is constant, the imaging range of the diagnostic imaging apparatus can be easily entered and confirmed. Since it is excellent in descriptiveness and firmly bites into the tissue at the drilling position, there is no fear of detachment from the position or deviation. Further, the large size makes it easy to recognize the excision region as an index when the excision area is gradually palpated or visually checked with the marker portion at the stage of excision of the lesion.
Furthermore, although the outer diameter of the marker device itself is formed larger than in the past, since the outer tube is not used, the puncture wound to the skin tissue that is not excised by surgery is equivalent to that of the conventional outer tube, Alternatively, it can be made rather small. (Compared by the outer diameter of the conventional outer tube and the outer diameter of the puncture needle of the present invention.) That is, the puncture wound to the skin tissue is spiraled by puncturing by rotating the spiral portion. Even if it is formed large, the outer diameter of the puncture needle becomes large. Although the invasiveness to the perforated part is increased, for example, the contact surface with the tissue is increased, the marker device is included in the range where the marker device is cut together with the lesion part, so that the adverse effect on the human body due to the size is large. Is not big.
In addition, the outer diameter of the puncture needle is formed so as to be strong, and a gripping portion is provided at the base of the puncture needle, and the linear portion of the puncture needle is extended on the central axis of the spiral. Since the operation is performed by gripping the grip portion, the puncture operation is easy, and since the stiffness is strong and the rotation shaft is not shaken during the rotation puncture, the puncture can be surely performed straight.

In addition, by setting the outer diameter of the puncture needle to 0.6 mm or more and 1.8 mm or less, it is possible to provide a marker device that is well suited to this procedure. That is, if the outer diameter of the puncture needle is less than 0.6 mm, the stiffness of the needle tube will be weakened, and there is a concern that accurate puncture to the target site will not be successful, and delicateness is required for processing the needle tip and the spiral. There are concerns that manufacturing will be difficult. On the other hand, if it is larger than 1.8 mm, the skin left without being excised and the puncture wound to the subcutaneous tissue will be made larger than necessary, and there is a concern that it will be difficult to process the spiral formation. Further, in this operation, there is an operation of cutting the straight portion of the puncture needle at the skin portion after the marker portion is drilled in the mammary gland tissue, and there is a concern that cutting becomes difficult when the outer diameter becomes too large.
Furthermore, by setting the width of the spiral portion to 4 mm or more and 18 mm or less, it is possible to provide a marker device that is well suited to the present procedure. That is, if the spiral width is less than 4 mm, it becomes a fine spiral and requires delicate processing, making it difficult to manufacture, and depending on the stability (fixed certainty) and conditions when drilled in the tissue, There is a concern that the certainty of the depiction is impaired, and there is a concern that it becomes difficult to recognize the resection area as an index when the resection area is relied on the marker portion. On the other hand, if it is larger than 18 mm, the planned excision range is often about 20 mm around the lesion. Therefore, depending on the puncture method, there is a concern that a part of the spiral protrudes outside the planned excision range. There is a concern that the invasion to a healthy tissue serving as a puncture passage may be increased more than necessary.

  In addition, if the device is provided with a plate-like plate that regulates the puncture depth of the puncture needle, the plate is formed from an incision made in advance on the surface of the deepest part of the body of the puncture route when the puncture needle is punctured. Since the tip of the punctured puncture needle hits the surface of the inserted plate-shaped plate and stops by restricting the puncture depth, the punctured needle tube does not reach deeper than necessary. It is possible to eliminate the fear of erroneous puncture to the muscles, chest wall, vascular tissue, etc. in the rear part of the mammary gland tissue in the deep layer, and to provide a safe instrument that reduces the burden on the operator and the patient.

  According to the excision region marker instrument of the present invention, it is not necessary to use a guide instrument such as an outer tube for the puncture of the puncture needle, and the marker instrument has an optimal shape and size for procedures such as partial mammary gland excision. In addition to the fact that there is no detachment or misalignment of the instrument from the installation position after the marker portion has been drilled in the tissue, the visualization of the diagnostic imaging apparatus is clear, Therefore, it is possible to provide an excision region marker device that is easy to use and easy to manufacture, such as being easy to puncture into tissue and having excellent recognition as an index.

The block diagram which shows embodiment of this invention. The dimension diagram which shows the size of the puncture needle of the said form. The schematic diagram explaining the use condition of the said form.

Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.
FIG. 1 shows an embodiment of an ablation region marker instrument of the present invention, A is a front view, B is a top view, and FIG. 2 shows the size of the puncture needle of this embodiment.
The resection area marker device of this embodiment is a marker that serves as an index of a resection area that is perforated along the boundary inside the boundary of a pre-designed planned resection area that includes a lesion, such as in partial mammary resection A puncture needle 1 having a distal end side serving as a piercing portion as a spiral portion 11 having a cutting edge 110 and a proximal side serving as a straight portion 12, and a proximal end portion of the puncture needle 1. The basic structure is constituted by the gripping part 2.

In this example, the puncture needle 1 is made of a metal lot such as stainless steel having an outer diameter (a) of 0.9 mm, and is provided with a triangular pyramid cutting edge 110 at the tip on the tip side to be punctured into the tissue. (C) A range of about 30 mm is formed as a spiral portion 11 having a constant width of a width diameter (b) of 6 mm and a pitch (d) of 5 mm, and the base side is the central axis of the spiral portion 11 In this example to be extended, the straight portion 12 is formed with a length of about 50 mm.
The above-mentioned size is an example and is not specified. For example, in this example, the length of the spiral portion 11 is set to about 30 mm from the average breast thickness, but in the case of a large breast, it is 30 mm or more. In some cases, the device of the spiral portion 11 is effective, and an optimally sized device may be used as necessary.
However, as described above, if the outer diameter (a) of the puncture needle is less than 0.6 mm, there are concerns that the puncture needle may be inconvenient for puncture due to the small diameter, and that the processing may be troublesome. If the diameter is larger than 8 mm, there is a concern that the burden on the tissue becomes large or the processing becomes troublesome. Therefore, the size of the outer diameter (a) is in the range of 0.6 mm to 1.8 mm. As a result, it will be a suitable size.
Further, if the width (b) of the spiral portion 11 is less than 4 mm, there is a concern that delicate processing is necessary, the stability of puncture into the tissue, the certainty of description with the imaging device, and the excision of the lesion portion. There is a concern that the recognizability may be impaired, and when it is larger than 18 mm, there is a concern that a part of the spiral protrudes outside the planned excision range and a burden on the healthy tissue is increased more than necessary. Therefore, the width (b) of the spiral portion 11 is a size in which the range of 4 mm to 18 mm is suitable for the use of the present instrument.
The grip portion 2 is formed of a resin molded product, and if necessary, is provided with anti-slip processing such as knurl processing for improving workability during insertion of the puncture needle. Connected to the end.

Further, although not described in this example, a plate-like plate 3 (see FIG. 2) for regulating the puncture depth of the puncture needle 1 may be provided as necessary.
Prior to the puncture of the puncture needle 1 of the marker device, the plate-like plate 3 is cut in advance to insert the plate 3 so that the puncture needle 1 does not puncture the muscle, chest wall, blood vessel tissue, etc. at the rear of the mammary gland tissue. A marker device that is provided with a retractor and is inserted from the incision to the deepest part of the planned excision range (the deepest part of the puncture needle) so that the puncture needle 1 is not inserted beyond the set depth. It may be provided independently of each other, formed in a disk shape or the like with a resin having appropriate flexibility and rigidity, and may be provided with a gripping portion for improving operability as necessary.
In addition, the size is not specified, but it is necessary and sufficient considering the size of the tissue to be removed from the incision to the lower part of the excised tissue (the deep part of the human body) and the excision range. It is desirable that the diameter is about 60 mm to 120 mm, which is the minimum size within the range of the size, and the thickness is about 0.5 mm to 3 mm which is as thin as possible while maintaining strength.
By using the plate-like plate 3, it is possible to prevent a serious accident such as an erroneous puncture of the muscle, chest wall, or vascular tissue at the rear of the mammary gland tissue by the puncture needle 1.

Next, a situation where the instrument of the present embodiment is used for a partial mammary resection operation will be briefly described.
1. The position of the lesion is specified in advance by an ultrasonic diagnostic apparatus (or MRI, multi-slice CT), the resection range is set, the boundary of the planned resection range is designed and marked on the skin 5, and the marking of the boundary is followed Then, a plurality of (usually about five) puncture needles are applied to the spiral and inserted perpendicularly to the skin surface 5 at appropriate intervals. (If necessary, the plate-like plate 3 is installed at a preset position before insertion of the puncture needle.) (See FIG. 3A)
2. The puncture needle 1 is cut on the skin surface, and the marker portion of the spiral portion 11 is embedded subcutaneously. (See Figure 3B)
3. In this state, the positional relationship between the spiral portion 11 of the puncture needle 1 and the lesion 6 is confirmed by intraoperative ultrasonography, and if it is not correct, it is corrected (a marker instrument is newly punctured or a scalpel is removed from the position of the punctured marker. Since the part to be inserted is known, correct the part to insert the knife.)
4). When the mark of the excision range is confirmed, the skin 5 is incised, and the skin 5 and the subcutaneous tissue are separated. (Flap formation)
5. The planned boundary line (surface) is separated while tactilely or visually confirming the spiral portion 11 of the marker device. In addition, the helical part 11 of a marker instrument is also included in the mammary gland tissue to be excised and excised together with the lesion part.

1. Puncture needle 11. Spiral part 110. Cutting edge 12. Straight part 2. 2. Grasping part 4. Plate-like plate Skin 6. Lesion

Claims (3)

In a marker instrument that is perforated around a lesion and defines a resection area, a puncture needle that has a cutting edge at the tip, spirals a predetermined length from the tip, and linearly forms the base side, and the puncture needle The width of the spiral portion is formed to be substantially constant, and the linear portion extends substantially along the central axis of the spiral so that the tissue can be punctured from the skin surface. An excision region marker device characterized by being able to puncture alone without rotating a puncture needle without using a guide device such as an outer tube .   The ablation area marker instrument according to claim 1, wherein the puncture needle is formed such that the outer diameter of the needle is 0.6 mm or more and 1.8 mm or less, and the width of the spiral portion is 4 mm or more and 18 mm or less.   The excision region marker instrument according to claim 1 or 2, wherein the marker instrument comprises a plate-like plate for regulating a puncture depth of the puncture needle.

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