KR102453419B1 - Biopsy marker - Google Patents

Abstract

The present invention relates to an instrument used for surgery, and more specifically, an auxiliary instrument that helps to confirm the location of a lesion for surgical excision of soft tissue and to observe the progress. It is a medical instrument used together with medical imaging equipment, and a marker having visibility. it is about
The device of the present invention is provided with a metal body recognized as medical imaging equipment in some sections of the suture having biocompatibility. When the suture is seated in the area of interest due to the metal body provided in the target and the suture, there is no inconvenience of using the existing needle or wire, and only the needle can be removed to maintain visibility.

Description

Visibility marker {Biopsy marker}

The present invention relates to an instrument used for surgery, and more specifically, an auxiliary instrument that helps to confirm the location of a lesion for surgical excision of soft tissue and to observe the progress. It is a medical instrument used together with medical imaging equipment, and a marker having visibility. it is about

With the development of medical technology, cancer treatment has developed dramatically and has reached a level where cure is possible. However, in the case of breast cancer, psychological and cosmetic dissatisfaction is caused by excessive excision of lesion tissue, so it is necessary to avoid excessive tissue excision through accurate positioning and proper boundary confirmation.

For example, in breast cancer, in most cases, a lesion is confirmed by mammography, but when a tissue biopsy is required, a biopsy sample is collected using a biopsy device. U.S. Publication No. 2009/0209854 of Devicore Corporation (title of the invention: "Biopsy Method", publication date: August 20, 2009) as a patent for injecting a marker to accurately mark a biopsy sample collection device and biopsy location. ; US Publication No. 2009/0270725 entitled "Devices Useful in Imaging," published on October 29, 2009; US Publication No. 2010/0049084 entitled "Biopsy Marker Delivery Device," published on February 25, 2010; US Publication No. 2011/0071423 (title of the invention: "Flexible Biopsy Marker Delivery Device", publication date: March 24, 2011) and the like.

However, the devices mentioned in the above patents have a complex structure and are expensive because their main purpose is to collect biopsy samples. , the tissue marker is maintained in the breast tissue of the patient, and if it is a tumor as a result of the analysis, it has to be removed along with excision of the tissue or maintained in the body to observe the progress.

As an improved method of injecting the marker, the marker of the beacon is a porous pipe made of PEEK material with a diameter of 15 mm and a length of 5 mm. It can be photographed and the virtual image is small and visible, but there is a disadvantage that it is difficult to see when it is migrated to adipose tissue.

In addition, Korean Patent Laid-Open Patent No. 10-2015-0070089 (title of the invention; "magnetic marker for surgical positioning", publication date: June 24, 2015) discloses a biopsy result of biopsy of nanoparticles having magnetism when tissue is to be removed. It is a method using a marker placed in an absorbent matrix, and it is premised that the gel-like bioabsorbable matrix is absorbed in the body after a certain period of time, but the safety of the nano material is not judged. None of the substances have been approved by the Food and Drug Administration (FDA), and studies on toxicity are still being conducted.

Also, it is a method like tattooing, diluting sterilized charcoal powder in saline solution and injecting it into the lesion site. fibrosis) and infection (inflammation), a skilled operator is required, and even after the lesion tissue is excised, the charcoal spreads to the skin surface and pigmentation occurs, so surgery is required to remove it.

In addition, as a method of injecting a metal wire, an injection needle or a flexible metal wire is injected along the edge of the lesion site. If the insertion is restricted and calcified, it is impossible to accurately recognize the image, and above all, it is rigid until the period of surgery to excise the lesion tissue, and a metal needle or wire with a length of 25 mm or more is used with flexibility. The inconvenience to the patient's daily life due to embedding in the breast tissue is very large.

On the other hand, in the Republic of Korea Patent Publication No. 10-2018-0071501 (title of the invention: "Visibility Marker", publication date: 02/28/2018), medical imaging equipment is placed in the center of the region of interest predicted to be a lesion in a cheaper and simpler way. Visibility markers for injecting clear markers through identification are disclosed.

However, as shown in the drawings, the above-described visibility marker forms a protrusion on a certain portion of the suture so that the suture is fixed to the flexible soft tissue.

The present invention provides a method for stably fixing the injected suture to the flexible soft tissue to enable identification through medical imaging equipment at the center of the region of interest predicted as a lesion as a means to solve the above problems. want to

The device of the present invention is provided with a metal body recognized as medical imaging equipment in some sections of the suture having biocompatibility. When the suture is seated in the area of interest due to the metal body provided in the target and the suture, there is no inconvenience of using the existing needle or wire, and only the needle can be removed to maintain visibility.

Biocompatible sutures can also be non-absorbable such as nylon, polypropylene, and polyester, but preferably polydioxanone, polylactide, polyglycolide, polycaprolactone, and absorbable sutures in which two or more of them are copolymerized or mixed. The metal body is embedded in the tip of the suture so that it can be recognized by medical imaging equipment such as X-rays without the injection of a contrast agent, so that the metal part can be positioned in the center of the region of interest predicted as a lesion through the imaging device, so the position can be adjusted by moving the needle Then, when the suture is seated in the area of interest, the needle is removed. At this time, even if the needle is removed, the suture is located in the center of the region of interest without being separated from the body or moving by the metal body that expands above the transition temperature, thereby preventing the inconvenience of inserting a rigid needle or wire into a flexible soft tissue. .

The device proposed in the present invention can be marked by inserting a needle with a suture embedded in the center of the region of interest and removing the needle when a lesion predicted to be cancerous in a soft tissue such as breast is identified through medical imaging equipment. In addition, since the rigid needle does not remain in the soft tissue, patient discomfort can be reduced. In addition, the suture is stably fixed by the metal body located at the tip of the suture, enabling recognition and tracking of the region of interest by various medical imaging equipment.

1 is a representative perspective view of a conventional marker injection device.
Figure 2 is an exemplary view using a magnetic marker using beads filled with magnetic particles.
3 is a PEEK material marker and a medical image photograph.
Figure 4 is a schematic view showing a method of forming a protrusion on the suture according to the prior art.
5 is a perspective view of a visibility marker according to the present invention.
6 is a view showing a suture according to a first embodiment of the present invention.
7 is a view showing a suture according to a second embodiment of the present invention.

When a lesion predicted to be cancerous in soft tissue is identified through medical imaging equipment, a metal body that does not transmit X-rays is provided in the center of the region of interest for marking, and placed at a specific site of a suture having biocompatibility. Insert a needle or trocar having a The length of the needle tube of the needle is 50 mm or more, and the outer wall has scales at regular intervals as shown in the PEEK marker in FIG. As a method to enable identification with medical imaging equipment, the surface roughness (roughness) of the needle tube is changed to enable identification due to scattering of sound waves in the scale area so that the needle tube can be distinguished from calcifications or linear fibromas in the ultrasound line. A flexible tube for temporarily fixing the suture is attached to the outside of the needle tube, and the material of the tube is a flexible material. Polyethylene, polyurethane, silicone, polycaprolactone, and derivatives thereof are possible. Non-degradable nylon, polypropylene, and polyester, as well as bioabsorbable polydioxane, polylactide, polyglycolide, polyglactin, polycaprolactone, etc. , multifilament is also possible.

The metal body used is not limited to the following metals, but may include gold, titanium, stainless steel, magnesium, and alloys thereof that have been used for insertion into the human body.

Hereinafter, specific embodiments of the present invention will be described.

first embodiment

The suture 40 according to the first embodiment of the present invention includes a metal body 60 as shown in FIG. 6 . The metal body 60 is formed in a cylindrical shape and is penetrated by the suture 40 .

The metal body 60 includes a plurality of first metallic filaments 61a and a plurality of second metallic filaments 61b and a fixing ring 63 .

The first metallic filament 61a and the second metallic filament 61b rotate in opposite directions to form a tubular body. And the fixing ring 63 is fixed to both ends of the first metallic filament (61a) and the second metallic filament (61b).

The first metallic filament 61a and the second metallic filament 61b expand into a set shape above the transition temperature. Specifically, the first metallic filament 61a and the second metallic filament 61b memorize a specified shape during a special heat treatment, and may be deformed into a specific shape set under appropriate conditions. That is, the first metallic filaments 61a and the second metallic filaments 61b expand in a specific shape set above the transition temperature.

At this time, since the fixing ring 63 made of a rigid body whose shape is not deformed is fixed to both ends of the plurality of first metallic filaments 61a and the second metallic filaments 61b, a first metallic filament forming a tubular body ( 61a) and the central portions of the second metallic filaments 61b are expanded.

And a protrusion 70 is formed on the surface of the suture 40 . The protrusions 70 are formed to be positioned on both sides of the metal body 60 by cutting the surface of the suture 40 . In addition, the protrusions 70 positioned on both sides of the metal body 60 are cut in opposite directions to open in opposite directions. Accordingly, the metal body 60 does not deviate from the position between the protrusions 70 .

The metal body 60 as described above has flexibility at a temperature of about 30° C. or less, and expands at a temperature of 35° C. or more. Accordingly, when the suture 40 is inserted into the lesion site, the central portions of the first metallic filament 61a and the second metallic filament 61b expand, so that the suture 40 is fixed to the lesion site.

second embodiment

The suture 40 according to the second embodiment of the present invention includes a metal body 60 as shown in FIG. 7 . The metal body 60 is formed in a cylindrical shape and is penetrated by the suture 40 .

The metal body 60 includes a fixing ring 63 , a first metal unit 62a and a second metal unit 62b.

One end of the first metal unit 62a is fixed to the fixing ring 63 , and one end of the second metal unit 62b is connected to the other end of the first metal unit 62a .

Specifically, the first metal unit 62a is bent in a zigzag shape to form a tubular body, and the second metal unit 62b is bent in a zigzag shape to form a tubular body. The first metal unit 62a and the second metal unit 62b connected to each other are positioned side by side to form a single tubular body.

The first metallic unit 62a and the second metallic unit 62b have the same shape as the metallic filament of the first embodiment, memorize a specified shape during a special heat treatment, can be deformed into a specific shape set under appropriate conditions, and a fixed ring ( 63) is made of a rigid body whose shape is not deformed.

Meanwhile, the second metal unit 62b has a higher expansion rate than the first metal unit 62a. Accordingly, one end of the first metal unit 62a is restricted from deformation in shape by the fixing ring 63, and the second metallic unit 62b has one end of the first metallic unit 62a that is subject to deformation in shape. are constrained As a result, when the metal body 60 is inserted into the lesion site, it expands from the fixing ring 63 toward the other end of the second metal body 60 so that the suture 40 is fixed to the lesion site.

Also in the second embodiment, the protrusions 70 are formed on the suture 40, and since these protrusions 70 are the same as those of the first embodiment, a detailed description thereof will be omitted.

10: protective cap 20: needle tube
30: handle 40: suture
50: suture temporary fixing tube 60: metal body
61a: first metallic filament 61b: second metallic filament
62a: first metal unit 62b: second metal unit
63: fixing ring 70: protrusion
100: catheter 200: trocar

Claims (7)

In the medical visibility marker,
A metal body recognized as a medical imaging device is provided in some sections of the suture having biocompatibility, and when the region of interest is visualized using the imaging device, it is targeted to the center of the region of interest using a needle with the suture embedded in it, and the metal body is Medical visibility marker, characterized in that it is configured to remove the needle after fixing the suture to the area of interest by the expansion of the. The method of claim 1,
The metal body,
A plurality of first metallic filaments rotating in any one direction to form a tubular body;
a plurality of second metallic filaments rotating in an opposite direction to the first set of metallic filaments to form a tubular body;
It consists of two fixing rings to which both ends of the first metallic filament and the second metallic filament are fixed,
The first metallic filament and the second metallic filament are medical visibility markers, characterized in that the expanded shape is set above the transition temperature. The method of claim 1,
The metal body,
fixing ring,
a first metal unit bent in a zigzag shape to form a tubular body, one end of which is fixed to the fixing ring;
It is bent in a zigzag shape to form a tubular body, and one end is made of a second metal unit connected to the other end of the first metal unit,
The medical visibility marker, characterized in that the first metal unit and the second metal unit have different expansion rates. The method of claim 1,
Medical visibility marker, characterized in that by cutting the surface of the suture to form protrusions located on both sides of the metal body. 5. The method of claim 4,
The protrusions are cut in opposite directions to each other, and the medical visibility markers are formed so as to spread in opposite directions. delete The method of claim 1,
The suture is formed of one of non-degradable nylon, polypropylene, polyester, bioabsorbable polydioxane, polylactide, polyglycolide, polyglactin, and polycaprolactone, and a hollow fiber having an internal cavity, monofilament, multi Medical visibility marker, characterized in that composed of one of the filaments.

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