WO2021200573A1

WO2021200573A1 - Breast treatment instrument

Info

Publication number: WO2021200573A1
Application number: PCT/JP2021/012635
Authority: WO
Inventors: 毅彦内田
Original assignee: 株式会社日本医療機器開発機構
Priority date: 2020-03-30
Filing date: 2021-03-25
Publication date: 2021-10-07
Also published as: JP6871654B1; JP2021154040A

Abstract

[Problem] To provide a treatment instrument for performing breast treatment that is not dependent on breast protheses and that keeps post-operation wounds small. [Solution] A breast treatment instrument 1 includes a pack part 3 that is inserted into the precordium, and an exoskeleton part 5 set on an outer periphery of the pack part 3. Firstly, the pack part 3 and the exoskeleton part 5 are inserted into the precordium, and the pack part 3 is inflated to expand the exoskeleton part 5. Then, the pack part 3 is slightly deflated, and is held for a set period of time in that state. Then, patient tissues such as fat and the like surround the exoskeleton part 5, and the tissues form in the gap between the pack part 3 and the exoskeleton part 5. The pack part 3 is deflated in a step-like manner, thereby expanding the formation range of the tissues. As a result, the reconstruction of the breast by patient cells, without using breast protheses, becomes possible. Additionally, the incision range needed to insert and remove the breast treatment instrument 1 is minimized.

Description

Breast treatment tool

The present invention relates to a breast treatment tool used for breast treatment such as breast reconstruction and breast augmentation.

Traditionally, surgical treatment has been performed to remove a tumor in the breast by surgery. In recent years, breast-conserving surgery, in which only the lesion tissue is partially removed, has become widespread because total breast removal in breast cancer or breast tumor resection puts an excessive physical, mental, or social burden on the patient. I'm doing it. However, even partial excision of the lesion causes depression in the affected area, which imposes a heavy burden on the patient. As a result, an increasing number of patients are undergoing breast reconstruction after breast tumor resection, including total mastectomy and breast-conserving surgery. As breast reconstruction surgery, implant surgery is generally performed in which, for example, an artificial breast made of silicon is implanted in the defect site where the tumor lesion tissue of the breast is excised.

Patent Document 1 discloses an expander as a treatment tool used for breast reconstruction in order to secure a space (pocket) for implanting an artificial breast. The expander described in Patent Document 1 includes a cover having an overall hemispherical shape and a tube for injecting a fluid into the cover. In breast reconstruction using this expander, the skin is first inserted under the affected skin (precordium including the pectoralis major muscle), and fluid is injected into the breast through a tube to inflate the skin. Form a space below. The capsule is then surgically removed and an appropriately sized breast prostheses are placed in the space under the skin.

Japanese Unexamined Patent Publication No. 61-131741

The treatment tool described in Patent Document 1 aims to form a space under the skin by using the treatment tool, and after forming the space, it is removed and an artificial breast made of silicon is implanted in the formed space. Or, it is premised on implanting a living tissue such as a flap or the like. However, first of all, since such artificial breasts are non-absorbable, they may cause infection, and there are concerns about adverse effects such as allergies and carcinogenesis due to contact. Secondly, in the case of transplantation using autologous tissue, the autologous tissue is transplanted from other body parts of the patient, which not only causes great invasion to the patient, but also requires anastomosis and engraftment of arteries and veins, which is highly advanced. It requires medical technology and is hindering its widespread use.

In breast reconstruction using this treatment tool, it is necessary to implant an artificial breast or autologous tissue that matches the size of the space in the space under the skin formed by inflating the wound. An incision large enough to insert these buried plants in the breast must be performed near the breast, leaving a relatively large wound after surgery. Furthermore, the process of forming a space under the skin using this treatment tool generally takes 6 weeks or more, depending on the size of the excised breast tissue. During that time, the patient is forced to undergo outpatient treatment multiple times in order to insert a fluid such as physiological saline into the treatment tool. In addition to this, breast reconstruction surgery is performed after sufficient space has been formed, but it is dangerous because the surgery is performed again under general anesthesia 6 weeks or more after the breast tumor is removed.

Therefore, it is a main object of the present invention to enable breast treatment that can suppress postoperative wounds to a small size without relying on buried plants such as artificial breasts and autologous tissues.

As a result of diligent studies on means for achieving the above object, the inventor of the present invention has formed an exoskeleton portion that expands with the expansion of the pack portion around the pack portion that expands or contracts due to injection or discharge of fluid. It was found that by arranging the breast, it is possible to reconstruct the breast (adipocytes) without burying plants such as artificial breasts and autologous tissues, and it is possible to keep the wound caused by the incision small. Then, the present inventor has come up with the idea that the problems of the prior art can be solved based on the above findings, and has completed the present invention. Specifically, the present invention has the following configuration.

The present invention relates to a breast treatment tool 1 used for breast treatment such as breast reconstruction or breast augmentation. The breast treatment tool 1 according to the present invention mainly includes a pack portion 3 inserted inside the precordium and an exoskeleton portion 5 installed on the outer periphery of the pack portion 3. The pack portion 3 can be injected with a liquid such as physiological saline or a gas such as carbon dioxide, and expands by injecting these fluids and contracts by discharging the fluid. The exoskeleton portion 5 is arranged along the outer surface of the pack portion 3 and is configured to extend as the pack portion 3 expands. Further, the pack portion 3 and the exoskeleton portion 5 are separated from each other, and when the exoskeleton portion 5 is extended by the expansion of the pack portion 3 and then the exoskeleton portion 3 is contracted, the exoskeleton portion 5 is in the extended state. It is maintained and a gap is created between the pack portion 3 and the exoskeleton portion 5. Therefore, it is possible to remove the contracted pack portion 3 from the body while leaving the extended exoskeleton portion 5 in the living body.

In the operation using the breast treatment tool 1 according to the present invention, the pack portion 3 and the exoskeleton portion 5 are first inserted into the precordium, the exoskeleton portion 5 is extended by inflating the pack portion 3, and then the exoskeleton portion 5 is extended. The pack portion 3 is slightly contracted and held as it is for a certain period of time. Then, self-tissue such as fat surrounds the exoskeleton portion 5, and self-tissue is formed in the gap between the pack portion 3 and the exoskeleton portion 5. Then, by gradually contracting the pack portion 3 to expand the formation range of the self-tissue, the breast can be finally reconstructed by the self-cells without using the artificial breast. In addition, the pack part 3 and the exoskeleton part 5 can be inserted into the precordium in a state of being slightly contracted, and when the pack part 3 is removed, the pack part 3 is also in a state of being slightly contracted. The incision range required for inserting and removing the tool 1 is minimal. Therefore, according to the present invention, postoperative wounds can be minimized.

The breast treatment tool 1 according to the present invention may further include a port portion 7 for connecting the pack portion 3 and the outside of the body. As the port portion 7, for example, a tubular member for injecting a fluid into the pack portion 3 or discharging the fluid in the pack portion 3 is used. As a result, the expansion and contraction of the pack portion 3 can be freely controlled. In addition, the pack portion 3 can be easily pulled out of the body via the port portion 7.

In the breast treatment tool 1 according to the present invention, the exoskeleton portion 5 is preferably made of a bioabsorbable material. As a result, the exoskeleton portion 5 is gradually absorbed into the living body after the operation, so that it is not necessary to remove the exoskeleton portion 5 from the living body.

Another aspect of the present invention is a breast treatment method using the above-mentioned breast treatment tool 1. Examples of breast treatment methods are breast reconstruction and breast augmentation. In the breast treatment method, first, the pack portion 3 and the exoskeleton portion 5 included in the breast treatment tool 1 are inserted into the precordium. Next, the exoskeleton portion 5 is extended by expanding the pack portion 3 in the living body. Next, by contracting the pack portion 3 with the exoskeleton portion 5 extended, a gap is formed between the pack portion 3 and the exoskeleton portion 5. After that, by maintaining the state in which this gap is formed for a certain period of time, self-tissues such as adipocytes are formed around the exoskeleton portion 5 and in the gap between both

members

3 and 5. Alternatively, a biocompatible material such as an allogeneic tissue or an artificial material may be injected into the gap between the two

members

3 and 5. After that, the pack portion 3 is gradually contracted to expand the formation range of the self-organization. Finally, the small contracted pack 3 is surgically removed and the breast is reconstructed or enlarged by the exoskeleton 5 and self-tissue. When the exoskeleton portion 5 is made of only a bioabsorbable material, the exoskeleton portion 5 is gradually absorbed into the living body after the operation and finally collapses.

According to the present invention, it is possible to perform breast treatment that can suppress postoperative wounds to a small size without relying on artificial breasts such as silicone implants or buried plants such as autologous tissues.

FIG. 1 schematically shows the configuration of the breast treatment tool 1 according to the present invention. FIG. 2 is a cross-sectional view schematically showing breast treatment using the breast treatment tool 1. FIG. 3 is a cross-sectional view schematically showing breast treatment using the breast treatment tool 1.

Hereinafter, a mode for carrying out the present invention will be described with reference to the drawings. The present invention is not limited to the forms described below, and includes those which are appropriately modified by those skilled in the art from the following forms to the extent obvious to those skilled in the art.

FIG. 1 shows an example of the breast treatment tool 1 according to the present invention. As shown in FIG. 1, the breast treatment tool 1 basically includes a pack portion 3, an exoskeleton portion 5, and a port portion 7. The port portion 7 is a pipe for transferring a fluid (gas or liquid), one end of which is connected to the inside of the pack portion 3 and the other end of which is connected to a device (omitted) for supplying and discharging the fluid. There is. The pack portion 3 is configured to expand when a fluid is supplied to the inside of the pack portion 7 via the port portion 7, and contract when the fluid is discharged from the inside of the pack via the port portion 7. Further, the exoskeleton portion 5 is arranged so as to surround the periphery of the pack portion 3. Although the exoskeleton portion 5 extends as the pack portion 3 expands, the extended state remains maintained even if the pack portion 3 shrinks.

The pack portion 3 is formed of a biocompatible resin material. Examples of the material of the pack portion 3 include polyamide resin, polyamide elastoma, polyester, polyurethane, polyvinyl chloride resin, polyolefin resin such as polyethylene, polypropylene and ethylene-propylene copolymer, and fluororesin such as Teflon (registered trademark). Various synthetic resin materials such as ethylene-vinyl acetate copolymer can be adopted. Further, as the material of the pack portion, various biocompatible elastic resin materials such as silicone rubber, latex rubber, butyl rubber, isoprene rubber, polyurethane elastomer, fluororubber, and natural rubber can be adopted. The volume of the pack portion 3 may be adjusted to the volume of the breast to be treated, and may be selected in the range of, for example, 200 to 1000 ml.

The exoskeleton portion 5 is a member configured to be irreversibly extendable structurally or materially. In the example shown in FIG. 1, the exoskeleton portion 5 has a mesh shape having a plurality of refraction points or curved points in the state before extension, and the whole is irreversibly extended by extending these refraction points or curved points. It is configured to do. The extension structure of the exoskeleton portion 5 is not limited to the one shown in the drawing, and a known mesh-type extension structure used in a medical bioexpansion member such as a stent can be appropriately adopted. Since the exoskeleton portion 5 needs to be extended as the pack portion 3 expands, it is preferable that the exoskeleton portion 5 is arranged so as to surround the entire circumference of the pack portion 3. However, as long as it extends due to the expansion of the pack portion 3, there may be a portion around the pack portion 3 that is not partially covered by the exoskeleton portion 5. Further, the exoskeleton portion 5 can be formed of an irreversibly extendable metal material or the like without depending on the structural extension structure.

Further, as will be described later, the exoskeleton portion 5 is a bioabsorbable (biodegradable) material that retains strength until the adipose tissue is regenerated and the breast is reconstructed, and then absorbed into the living body. Is preferable. Examples of bioabsorbable materials are metals such as magnesium and polymers such as polylactic acid (D-, L-, meso, or mixtures thereof). As the bioabsorbable polymer, in particular, polyL-lactic acid (PLLA) can be used, and other polylactic acid polymers (PLA) and polylactic acid glycolic acid copolymers (PLGA) can also be adopted. The weight average molecular weight of polylactic acid is usually about 4000 to 200,000. The weight average molecular weight is a value measured using GPC. The exoskeleton portion 5 is not limited to the above-mentioned bioabsorbable material, and biocompatible metals such as titanium, stainless steel, Ti—Ni alloy, and Co—Cr alloy can also be used.

A known medical tube can be used as the port portion 7, and the material and structure thereof are not particularly limited.

2 and 3 are cross-sectional views showing an example of breast treatment (breast reconstruction or breast augmentation) using the breast treatment tool 1 according to the present invention. First, as shown in step (a) of FIG. 2, the pack portion 3 and the exoskeleton portion 5 are inserted into the precordium for the purpose of breast reconstruction or breast augmentation. At this time, one end of the port portion 7 is connected to the pack portion 3. Further, the port portion 7 may be installed on the skin of the patient or may be implanted under the skin.

Next, as in step (b), a liquid such as physiological saline or a gas such as carbon dioxide is injected into the pack portion 3 via the port portion 7. As a result, the pack portion 3 expands. Further, as the pack portion 3 expands, the exoskeleton portion 5 installed along the outer surface of the pack portion 3 extends. Then, the precordium to be treated swells so as to be pushed from the inside by the pack part 3 and the exoskeleton part 5, and the shape is maintained by being supported from the inside by the exoskeleton part 5, in particular.

Next, as in step (c), a part of the fluid injected into the pack portion 3 is discharged to the outside through the port portion 7. As a result, the pack portion 3 partially contracts. On the other hand, the exoskeleton portion 5 remains extended inside the precordium and continues to maintain the shape of the precordium. Therefore, a gap is formed between the outer surface of the pack portion 3 and the exoskeleton portion 5.

Next, a predetermined period of time elapses with the gap formed between the pack portion 3 and the exoskeleton portion 5 in step (c). As a result, as in step (d), the patient's own fat cells and other autologous cells surround the exoskeleton portion 5, and the autologous cells also form a gap between the pack portion 3 and the exoskeleton portion 5. One layer is formed. The predetermined waiting period described above may be set in consideration of the period during which autologous cells are sufficiently formed in this gap, and generally requires a period of about 1 to 6 months. It is also possible to inject biocompatible substances such as autologous adipose tissue, stem cells for regenerative medicine, allogeneic tissue, and artificial substances into the gap between the pack portion 3 and the exoskeleton portion 5. As a result, the waiting period for autologous cell formation can be shortened.

Next, after a sufficient layer of autologous cells or the like is formed in the gap between the pack portion 3 and the exoskeleton portion 5, the inside of the pack portion 3 is formed via the port portion 7 as shown in step (e) shown in FIG. A fluid is injected into the pack portion 3 to expand the pack portion 3 again. In this way, by expanding the pack portion 3 and compacting the autologous cells between the pack portion 3 and the exoskeleton portion 5 from the inside, it becomes easy to maintain the shape of the breast after reconstruction.

Next, as in step (f), the pack portion 3 is partially contracted by discharging a part of the fluid in the pack portion 3 to the outside through the port portion 7, and the first layer of the autologous cells is formed. A gap is formed again with the outer surface of the pack portion 3. At this time, the member constituting the pack portion 3 is preferably made of a material that does not easily adhere to the first layer of autologous cells.

Next, a predetermined period of time elapses with a gap formed between the first layer of the autologous cell and the pack portion 3 by step (f). As a result, as in step (g), the second layer of the autologous cell is formed in the gap between the first layer of the autologous cell and the pack portion 3. The waiting period here may be set in consideration of the period during which autologous cells are sufficiently formed in this gap, and generally requires a period of about 1 to 6 months. It is also possible to inject biocompatible substances such as autologous adipose tissue, stem cells for regenerative medicine, allogeneic tissue, or artificial substances into the gap between the first layer of the autologous cells and the pack portion 3. As a result, the waiting period for autologous cell formation can be shortened.

After that, by repeating steps (e) to (g), the layer of autologous cells is gradually increased. In this way, the volume of the pack portion 3 is gradually reduced, and these steps are repeated until the pack portion 3 has a size sufficiently small so that it can be taken out of the body through a small incision. As a result, the wound when removing the pack portion 3 can be minimized. On the other hand, the exoskeleton part 5 will continue to remain in the body as it is, but by making the exoskeleton part 5 made of a bioabsorbable material, it is gradually absorbed into the living body with the passage of time after the operation. ， Eventually it collapses. Therefore, the shape of the breast can be maintained by the exoskeleton portion 5 for a certain period after the operation. Moreover, since the exoskeleton portion 5 collapses spontaneously, it is not necessary to separately perform an operation to remove the exoskeleton portion 5. If it becomes unnecessary to perform conventional breast reconstruction under general anesthesia in the remote period, the burden on the patient can be significantly reduced.

As described above, in the specification of the present application, in order to express the content of the present invention, the embodiments of the present invention have been described with reference to the drawings. However, the present invention is not limited to the above-described embodiment, and includes modifications and improvements which are obvious to those skilled in the art based on the matters described in the present specification.

The present invention relates to a breast treatment tool used for breast treatment such as breast reconstruction and breast augmentation. Therefore, the present invention can be suitably used in the manufacturing industry of medical devices.

1 ... Breast treatment tool 3 ... Pack part 5 ... Exoskeleton part 7 ... Port part

Claims

A pack part (3) that is inserted inside the precordium and can be expanded and contracted,
Includes an exoskeleton portion (5) that is installed on the outer periphery of the pack portion (3) and extends as the pack portion expands.
The pack portion (3) and the exoskeleton portion (5) are separated from each other.
When the exoskeleton portion (5) is extended by the expansion of the pack portion (3) and then the exoskeleton portion (3) is contracted, the exoskeleton portion (5) is maintained in the extended state. Breast treatment tool (1) from which the pack portion (3) is removed from the body.
The breast treatment tool (1) according to claim 1.
Further including a port portion (7) for connecting the pack portion (3) and the outside of the body,
Breast treatment tool (1).
The breast treatment tool (1) according to claim 1.
The exoskeleton portion (5) is made of a bioabsorbable material.
Breast treatment tool (1).
The breast treatment tool (1) according to claim 1.
Used for breast reconstruction or breast augmentation,
Breast treatment tool (1).
The breast treatment tool (1) according to claim 2.
The contracted pack portion (3) is removed from the body via the port portion (7) while leaving the extended exoskeleton portion (5) in the living body.
Breast treatment tool (1).