WO2014175365A1

WO2014175365A1 - Tissue expander

Info

Publication number: WO2014175365A1
Application number: PCT/JP2014/061513
Authority: WO
Inventors: 功一渡部; 長弘高橋; 陽一郎森久
Original assignee: 学校法人久留米大学
Priority date: 2013-04-25
Filing date: 2014-04-24
Publication date: 2014-10-30
Also published as: JP6326044B2; JPWO2014175365A1

Abstract

Provided is a tissue expander with which reliable expansion of skin is possible. The tissue expander (10) is equipped with a base plate (15) fastened to the back surface of skin (20), and a pouch body (14) held between the back surface of skin (20) and the base plate (15). The tissue expander (10) is designed to expand the skin (20) through dilation of the pouch body (14) between the back surface of skin (20) and the base plate (15). The pouch body (14) can thereby be received and retained by the base plate (15), even in instances in which the expanding pouch body (14) sinks towards the inside of the body due to repellant force of the skin (20). The pouch body (14) can thereby be reliably distended out towards the skin side, and the skin (20) can be expanded in a reliable manner.

Description

Tissue expander

The present invention relates to a tissue dilator, and more particularly to a measure for fixing the tissue dilator.

2. Description of the Related Art Conventionally, a tissue dilator used for collecting skin transplanted into a defect portion from a human body in a regenerative operation of the defect portion of the skin or soft tissue has been known (see, for example, Patent Document 1).

This tissue dilator includes a bag, an injection port, and a tube. The bag and the injection port are connected via a tube. When the needle of the syringe is inserted into the injection port and physiological saline in the syringe is injected into the injection port, the physiological saline is sent from the injection port to the bag-like body through the tube, and the bag-like body is inflated.

In the first operation, for example, an incision is made in the skin of the jaw and a tissue dilator is placed behind the skin of the jaw. At this time, it arrange | positions so that the bag-like body of a tissue dilator may come to the back side of the skin to expand. Thereafter, the first operation is completed by sewing the skin with the tissue dilator placed on the back side of the skin.

After the first operation, the physiological skin is sent from the outside of the human body to the bag-like body of the tissue dilator using a syringe, and the bag-like body is inflated to expand the skin of the jaw.

In the second operation, the skin of the expanded jaw is excised, and at the same time, the tissue dilator is removed, and the excised skin is transplanted to the above-described defect portion. Thereby, reproduction | regeneration of a missing part is achieved.

Special table 2013-509223 gazette

However, in the case of the conventional tissue dilator, there is a problem that the skin cannot be sufficiently expanded if there is no hard tissue such as bone near the skin to be expanded. For example, in the abdomen, buttocks, or thigh, the soft tissue between the skin and bone is thicker than in the case of the jaw described above. When the tissue dilator is installed on the back side of the skin of these parts, as shown in FIG. 9, even if an attempt is made to inflate the bag-like body (100) of the tissue dilator, the bag is received by the repulsive force of the skin (120). The body (100) itself sunk into the inner side of the human body (soft tissue (110) side), and the skin (120) could not be expanded reliably.

The present invention has been made in view of the above-described problems, and an object thereof is to provide a tissue dilator that can reliably expand the skin.

The first invention includes a fixing member (15) fixed to the back surface of the skin (20), and a bag-like body (14) held between the back surface of the skin (20) and the fixing member (15). The bag-like body (14) is a tissue dilator that expands the skin (20) by expanding between the back surface of the skin (20) and the fixing member (15).

According to a second aspect of the present invention, in the first aspect, the fixing member (15) has a flange portion (17) extending outward from the bag-like body (14), and the flange of the fixing member (15) The part (17) includes an adhesion part (19) to which a fibrous coating (21) formed from the back surface of the skin (20) adheres.

In addition, in a third aspect based on the second aspect, the fixing member (15) is arranged such that the surface of the adhesion part (19) and the back surface of the skin (20) are adjacent to the fixing member (15). ) Is formed in the thread hole (26) through which a thread (27) is sewn to the skin (20).

According to a fourth aspect of the present invention based on the third aspect, the thread hole (26) of the fixing member (15) penetrates the inner peripheral edge of the flange (17) with which the bag-like body (14) contacts. Is formed.

Further, in a fifth invention according to any one of the second to fourth inventions, the adhesion portion (19) of the fixing member (15) has a plurality of protrusions (18) formed on a surface thereof.

Further, the sixth invention is the invention according to any one of the second to fourth inventions, wherein the adhesion portion (19) of the fixing member (15) has a plurality of depressions (30) formed on the surface thereof.

In addition, according to a seventh aspect based on the fifth aspect, the protrusion (18) of the adhesion portion (19) has at least a portion having a portion whose cross-sectional area increases from the proximal end side toward the distal end side. (23).

According to the present invention, since the fixing member is fixed to the back surface of the skin and the bag-like body is held between the fixing member and the skin, the bag-like body swells between the fixing member and the skin. Even when the skin is going to sink into the human body due to the repulsive force of the skin, the bag-like body that is about to sink can be received and held by the fixing member. Thereby, a bag-like body can be reliably bulged to the skin side, and skin can be expanded reliably.

In this way, since the tissue dilator does not sink even if the bag-like body swells, the conventional tissue dilator cannot sufficiently expand the skin (a relatively thick soft tissue on the back side of the skin). The abdomen, buttocks, thighs, etc.) can be reliably expanded.

In addition, according to the second aspect, by providing the fixing member with the buttocks, the fibrous coating formed from the back surface of the skin in response to the foreign substance in the body can easily adhere to the buttocks, Thus, the fixing member can be firmly fixed to the back surface of the skin.

According to the third invention, by forming the thread hole in the fixing member, the thread is passed through the thread hole, and the fixing member is sewn to the skin so that the surface of the adhesion part of the buttocks and the back surface of the skin are adjacent to each other. The fixing member can be temporarily fixed to the skin until the fibrous coating described above is firmly adhered to the buttock. In addition, when the bag-like body is inflated in a state where the film is not firmly attached to the buttocks, the tissue dilator can be prevented from sinking.

According to the fourth invention, by arranging the thread hole in the inner peripheral edge of the heel part, when the fixing member is sewn to the skin through the thread through the thread hole, the skin is attracted to the inner peripheral edge part of the heel part. Can do. Thereby, a film can be reliably made to adhere also to the inner peripheral part of a collar part. If the film is adhered only to the outer peripheral edge of the heel, the gap between the adhesion portion and the bag-like body is larger than when the film is adhered to the inner peripheral edge. The larger the gap, the more the skin around the bag-like body is drawn toward the bag-like body when the bag-like body swells, and the skin is not sufficiently expanded. According to the present invention, since the gap between the adhesion portion and the bag-like body can be reduced, the skin can be sufficiently expanded when the bag-like body swells.

Further, according to the fifth invention, by forming protrusions on the buttock, the adhesion surface of the buttock can be enlarged, and more coatings can be bonded compared to the case where there is no protrusion. . In addition, by providing a plurality of protrusions, the coating can enter the gap between the protrusions. Since the coating that has entered the gap is difficult to remove, the fixing member can be more strongly fixed to the skin.

Also, according to the sixth invention, by forming the depression in the buttock, the adhesion surface of the buttock can be enlarged similarly to the protrusion described above. Moreover, since the coating film that has entered the inside of the recess is difficult to come off, the fixing member can be more firmly fixed to the skin.

Further, according to the seventh invention, by making the tip of the protrusion larger than the base end, the fibrous coating can be easily caught on the protrusion, and the fixing member can be more strongly fixed to the skin.

FIG. 1 shows a tissue dilator according to an embodiment of the present invention, in which (A) is a plan view and (B) is a side view. FIG. 2 is a diagram showing a protrusion on the buttock of the tissue dilator. FIG. 3 is a view showing a state in which the tissue dilator is placed in a subcutaneous pocket on the back side of the skin. FIG. 4 is a view showing a state in which the skin film has adhered to the protrusions of the buttocks of the tissue dilator. FIG. 5 is a diagram showing the state of the skin when the tissue dilator swells. FIG. 6 is a plan view of a tissue dilator according to Modification 1 of the embodiment of the present invention. FIG. 7 is a diagram showing a state of the skin when the tissue dilator according to the first modification of the embodiment of the present invention swells. FIG. 8 is a cross-sectional view of the vicinity of the depression of the tissue dilator according to the second modification of the embodiment of the present invention. FIG. 9 is a diagram showing the state of the skin when a conventional tissue dilator swells between the skin and soft tissue. FIG. 10 is a view showing a state of the skin when a conventional tissue dilator swells between the skin and the hard tissue.

Hereinafter, an embodiment of the present invention will be described in detail with reference to the drawings.

The tissue dilator (10) according to the embodiment of the present invention is used for collecting from a human body the skin to be transplanted into a defective part in a regenerative operation of the defective part of the skin or soft tissue. As shown in FIGS. 1 (A) and 1 (B), the tissue dilator (10) includes a main body (11), an injection port (12), and a tube (13). These are all made of silicon. These are configured as separate bodies, and when used as a tissue dilator (10), the main body (11) and the injection port (12) are connected by a tube (13) and assembled.

The main body (11) includes a bag-like body (14) and a bottom plate (15) as a fixing member. The bag-like body (14) includes a cylindrical portion (16a) that can be expanded and contracted in one direction. The opening portions at both ends of the cylindrical portion (16a) are closed by a pair of surfaces (16b, 16c) facing the expansion / contraction direction of the cylindrical portion (16a). The bottom plate (15) is fixed to one surface (16c) of the pair of surfaces (16b, 16c). The other surface (16b) serves as a pressing surface that presses the back surface of the skin when the bag-like body (14) swells.

The bottom plate (15) has a shape having four rounded corners in plan view. The bottom plate (15) is formed larger than the bag-like body (14) in plan view. A bag-like body (14) is fixed to a substantially central portion of the surface of the bottom plate (15). And the part of the outer peripheral side rather than the center part of a baseplate (15) is a collar part (17). An adhesion portion (19) having a plurality of protrusions (18) is formed on the heel portion (17).

On the surface of this adhesion part (19), when the tissue dilator (10) is placed behind the skin (20), it reacts with the foreign body (tissue dilator (10)) in the human body and the skin (20) The fibrous coating (21) created from the back side adheres. The bottom plate (15) is firmly fixed to the back surface of the skin (20) through the adhesion portion (19).

Further, as shown in FIG. 2, the protrusion (18) of the adhesion part (19) is formed continuously from the cylindrical part (22) and the end face of the cylindrical part (22) and goes from the proximal side to the distal side. And a distal end portion (23) whose cross-sectional area increases. The outer peripheral surface of the tip portion (23) is formed in a substantially conical shape, and the end surface on the tip side of the tip portion (23) is circular. The plurality of protrusions (18) are arranged at intervals so that the tip portions (23) do not contact each other. This is because if the tip portions (23) are brought into contact with each other, the fibrous coating (21) is difficult to enter between the projections (18).

Also, the bottom plate (15) is so soft that the back surface of the bottom plate (15) and the surface of the human body tissue fit when the tissue dilator (10) is left in the body for a certain period of time. Thereby, a dead space is not formed between the bottom plate (15) and the human body tissue, and the risk of infection by the dead space can be reduced. However, if the bottom plate (15) is too soft, it will be deformed when the bag-like body (14) swells, so that the bottom plate (15) It is set to be soft enough not to deform against the repulsive force of 20). The bottom plate (15) preferably has a lower elastic coefficient than that of the skin (20) and is hard.

In addition, the bottom plate (15) is formed with an insertion port (40) that passes through the center and opens into the bag-like body (14). One end of the tube (13) is inserted and fixed in the insertion port (40). The other end of the tube (13) is inserted and fixed in an insertion port (41) formed at the bottom of the injection port (12). The injection port (12) is formed in a hemispherical shape having a diameter of about 2 cm. Even if the needle of the syringe is inserted into the hemispherical surface of the injection port (12), physiological saline in the syringe does not leak out from the injection port (12). The physiological saline sent from the syringe to the injection port (12) is injected into the bag-like body (14) through the tube (13).

(Regenerative surgery using a tissue dilator)
Next, regenerative surgery using the tissue dilator (10) will be described.

First, the abdominal skin (20) is incised and the subcutaneous skin is peeled off to form a subcutaneous pocket (24) on the back side of the skin (20). Next, after assembling the tissue dilator (10), the operation of the tissue dilator (10) is checked. Thereafter, as shown in FIG. 3, the tissue dilator (10) in a state where the bag-like body (14) is contracted is placed in the subcutaneous pocket (24). At this time, it arrange | positions so that the pressing surface of the bag-like body (14) of a tissue dilator (10) may oppose the back surface of skin (20). Then, the first operation is completed by sewing the incised skin (20).

After the first operation, a fibrous coating (21) is formed from the back surface of the skin (20) toward the buttocks (17) in response to foreign substances in the human body. And a film (21) adheres to the adhesion part (19) of a buttocks (17). Thus, by forming the buttock (17) on the outer side of the bag-like body (14), the coating (21) can easily adhere to the buttock (17), and the skin ( The bottom plate (15) can be fixed to the back surface of 20).

Moreover, the surface area of the adhesion part (19) is expanded by the protrusion (18) of the adhesion part (19), and more coating (21) can be adhered. Thereby, a baseplate (15) can be firmly fixed to the back surface of skin (20). Further, about one month after the operation, as shown in FIG. 4, the coating (21) enters between the protrusions (18) and (18) on the surface of the adhesion part (19). Since the coating (21) that has entered the gap is difficult to remove, the bottom plate (15) can be more strongly fixed to the back surface of the skin (20). Also, by enlarging the tip of the protrusion (18) of the adhesion part (19) with the tip part (23), the coating (21) is easily caught by the protrusion (18), and the bottom plate (15) is attached to the skin (20). It can be fixed even more strongly.

The shape of the protrusion (18) should be such that the coating (21) is easily caught. However, if the degree of catching is too strong, the tissue dilator can be applied from the back of the skin (20) after the second operation to be described later. (10) becomes difficult to remove. This protrusion (18) is made of silicon, like the flange (17). When the tissue dilator (10) is pulled, a shape in which the protrusion (18) is deformed and the tissue dilator (10) is easily removed is preferable. Specifically, the height (h in FIG. 2) of the cylindrical portion (22) of the protrusion (18) is 6 to 7 mm, the diameter (d1 in FIG. 2) is 2 to 3 mm, the tip ( 23) The diameter of the tip surface (d2 in FIG. 2) is preferably 5 mm. Moreover, in this Embodiment, the tissue dilator (10) is made easy to remove from the back surface of skin (20) by making the outer peripheral surface (35) of a front-end | tip part (23) into a conical surface.

After that, the needle of the syringe is inserted into the abdomen, and the tip of the needle is inserted into the injection port (12) of the tissue dilator (10). Then, the bag-like body (14) is inflated by injecting physiological saline in the syringe from the injection port (12) into the bag-like body (14) through the tube (13). This injection operation is performed about twice a month.

When the injection work is completed, the abdominal skin (20) is expanded by the swelled bag (14) as shown in FIG. Since the conventional tissue dilator (10) does not have a fixing member, when the bag-like body (14) is inflated, the tissue dilator (10) sinks inward, and the skin (20) is sufficiently removed. Although it was not able to expand (refer FIG. 9), the tissue dilator (10) of this embodiment fixes the bottom plate (15) as a fixing member to the back surface of the skin (20), and the bottom plate (15 ) And the skin (20), the bag (14) is held between the skin (20) and the bag (14) swells between the bottom plate (15) and the skin (20). Even when trying to sink into the human body with the repulsive force, the bag-like body (14) that is about to sink can be received and held by the bottom plate (15). Thereby, the bag-like body (14) can be reliably bulged toward the skin (20), and the skin (20) can be reliably expanded.

In the second operation, the abdominal expanded skin (20) is removed. This excised skin (20) is transplanted into the defect. The tissue dilator (10) is then removed from the subcutaneous pocket (24). Here, since the protrusion (18) of the buttocks (17) of the tissue dilator (10) is made of elastic silicon, the protrusion (18) is deformed by the tensile force when pulled with some force. By doing so, the tissue dilator (10) can be easily removed from the back surface of the skin (20). Thereafter, the reconstructive operation is completed by sewing the skin (20) and the skin (20) of the incised portion.

(Modification 1 of one embodiment)
Unlike the one embodiment described above, the tissue dilator (10) of Modification 1 shown in FIG. 6 has a plurality of thread holes (26) formed in the heel part (17) of the bottom plate (15). . The thread (27) is passed through this thread hole (26), and the bottom plate (15) is sewn to the skin (20) so that the surface of the adhesion part (19) of the buttocks (17) and the back surface of the skin (20) are adjacent to each other. The bottom plate (15) can be temporarily fixed to the skin (20) until the fibrous coating (21) described above is firmly attached to the buttocks (17). Moreover, when the bag (14) is inflated with the film (21) not firmly attached to the buttocks (17), the tissue dilator (10) can be prevented from sinking. .

In the first regenerative surgery, after incising the skin (20), thread (27) is put on the back of the skin (20), and the tissue dilator (10) is placed in the subcutaneous pocket (24 ), The tissue expander (10) is fixed by passing the thread (27) through the thread hole (26) of the buttocks (17).

Further, in the first modification, the thread hole (26) is arranged on the inner peripheral edge of the heel part (17). Specifically, six pairs of thread holes (26) are arranged at intervals in the circumferential direction of the inner peripheral edge. The number of the thread holes (26) is merely an example, and the number is not limited.

Thus, by arranging the thread hole (26) on the inner peripheral edge of the buttocks (17), when the fixing member is sewn to the skin (20) through the thread (27) through the thread hole (26), the buttocks The skin (20) can be drawn to the inner peripheral edge of (17). Thereby, a film (21) can be reliably made to adhere also to the inner peripheral part of a collar part (17).

Assuming that the film (21) was only adhered to the outer peripheral edge of the buttocks (17), compared to the case where the film (21) was adhered to the inner peripheral edge, the adhesion part and the bag-like body ( 14) (see S in FIG. 5) increases. The larger the gap (S), the more the skin (20) around the bag (14) is drawn toward the bag (14) when the bag (14) swells. 20) will not be fully expanded.

A similar state occurs when the conventional tissue dilator bag (100) is placed on the upper side of the hard tissue (130) and inflated (see FIG. 10). In the case of the conventional tissue dilator, it is placed on the upper side of the hard tissue (130), so there is no sinking, but the skin (120) around the bag-like body (100) is drawn toward the bag-like body (100) side. And the skin (120) is not fully expanded.

According to the modified example 1, as shown in FIG. 7, the gap (S) between the adhesion portion of the coating (21) and the bag-like body (14) can be narrowed, so that the bag-like body (14) swells. When it is, the skin (20) can be fully expanded.

(Modification 2 of one embodiment)
The tissue dilator (10) of Modification 2 shown in FIG. 8 has a recess (30) instead of the protrusion (18) of the buttocks (17) of the tissue dilator (10) of Embodiment and Modification 1. Is formed. Thereby, the surface area of the adhesion part (19) can be expanded and more coating films (21) can be made to adhere to the adhesion part (19). As a result, the bottom plate (15) can be firmly fixed to the back surface of the skin (20). Moreover, since the coating (21) enters the inside of the depression (30) and the coating (21) is difficult to come out of the depression (30), the bottom plate (15) can be more firmly fixed to the back surface of the skin (20). it can.

Also, the recess (30) has an enlarged portion (31) whose inner diameter increases toward the bottom side. Thereby, the coating (21) is caught on the inner surface of the enlarged portion (31) and is difficult to come off, and the bottom plate (15) can be more firmly fixed to the back surface of the skin (20).

(Other embodiments)
In one embodiment and modification 1 or 2, the tissue dilator (10) is disposed in the abdomen, but is not limited to this, and a site where there is no hard tissue such as bone near the skin (20) to be expanded, For example, you may arrange | position to a thigh, a buttocks, or a breast. Even in this case, the skin (20) can be reliably expanded without the tissue dilator (10) being submerged.

In the embodiment and the first or second modification, the tissue dilator (10) is disposed in the abdomen, but the present invention is not limited to this, and there is a hard tissue such as a bone near the skin (20) to be expanded. It may be installed at the site. Even in this case, the gap (S) between the adhesion part of the coating (21) and the bag-like body (14) can be narrowed compared to the conventional tissue dilator (10). The skin (20) can be fully expanded when (14) swells.

Moreover, in one Embodiment and the modification 1 or 2, it was inflated by inject | pouring the physiological saline to a bag-like body (14), However, It is not limited to this, A bag-like body (14) is passage of time. It may be self-expanding together. Even in this case, the bag-like body (14) can be held between the fixing member and the skin (20), and the expansion of the bag-like body (14) can sufficiently expand the skin (20). it can.

In one embodiment and modification 1 or 2, the swelled shape of the bag-like body (14) was a cylindrical shape, but the swelled shape is not limited to this, and the swelled shape is hemispherical, teardrops. Or crescent shape. Further, the side wall of the bag-like body (14) may be bellows-like. The number of bellows may be one or more.

Moreover, in one Embodiment and the modification 1, although the outer peripheral surface (35) of the front-end | tip part (23) of the processus | protrusion (18) of the heel part (17) of the tissue dilator (10) was conical, However, the present invention is not limited to this, as long as it has a part whose cross-sectional area expands from the base end side to the tip end part, or may be spherical or hemispherical. Even in this case, the coating (21) is easily caught on the protrusion (18), and the bottom plate (15) can be more firmly fixed to the skin (20).

Further, in Modification 2, the depression (30) is provided in the heel part (17) to increase the surface area of the adhesion part (19). However, the present invention is not limited to this. For example, instead of the depression (30), a penetration is provided. The surface area of the adhesion part (19) may be enlarged by forming a hole.

It should be noted that the above-described embodiment is an essentially preferable example, and is not intended to limit the scope of the present invention, its application, or its use.

As described above, the present invention relates to the tissue dilator (10), and is particularly useful for measures for fixing the tissue dilator (10).

DESCRIPTION OF SYMBOLS 10 Tissue dilator 11 Main part 12 Injection | pouring port 13 Tube 14 Bag-shaped body 15 Bottom plate (fixing member)
17 buttock 18 protrusion 19 adhesion part 20 skin 21 coating 23 tip part 26 thread hole

Claims

A fixing member (15) fixed to the back surface of the skin (20);
A bag-like body (14) held between the back surface of the skin (20) and the fixing member (15);
The tissue expander characterized in that the bag-like body (14) expands the skin (20) by expanding between the back surface of the skin (20) and the fixing member (15).
The fixing member (15) has a flange portion (17) extending outward from the bag-like body (14),
The collar portion (17) of the fixing member (15) includes an adhesion portion (19) to which a fibrous coating (21) formed from the back surface of the skin (20) is adhered. Item 2. The tissue dilator according to Item 1.
Thread (27) for sewing the fixing member (15) to the skin (20) so that the front surface of the adhesion part (19) and the back surface of the skin (20) are adjacent to the fixing member (15) Tissue dilator according to claim 2, characterized in that a thread hole (26) through which is passed is formed.
The thread hole (26) of the fixing member (15) is formed so as to penetrate an inner peripheral edge portion of the collar portion (17) with which the bag-like body (14) contacts. 4. The tissue dilator according to 3.
The tissue dilator according to any one of claims 2 to 4, wherein a plurality of protrusions (18) are formed on a surface of the adhesion portion (19) of the fixing member (15).
The tissue dilator according to any one of claims 2 to 4, wherein a plurality of depressions (30) are formed on a surface of the adhesion portion (19) of the fixing member (15).
The protrusion (18) of the adhesion portion (19) includes a distal end portion (23) having at least a portion having a cross-sectional area increasing from the proximal end side toward the distal end side. Item 6. The tissue dilator according to Item 5.