Radiation therapy spacer

Abstract

To provide a spacer for radiotherapy treatment capable of reducing a burden on a patient.SOLUTION: A spacer for radiotherapy treatment 1 comprises: a balloon part comprising a balloon body 21 capable of having a fluid encapsulated therein and a communication channel 3 for communication between the inside and outside of the balloon body 21; and a closing part 4 for closing the communication channel 3. The balloon part 2 is formed of a biodegradable material. The closing part 4 may be formed of a biodegradable material. The balloon part 2 may be formed in a flat shape in a state where a fluid F is not encapsulated inside.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a spacer for radiotherapy and a spacer delivery system. [Background technology]

[0002] Conventionally, during radiation therapy, a spacer for radiation therapy is inserted between the affected area (tumor) and the normal tissue to protect the normal tissue surrounding the affected area from radiation exposure (see, for example, Patent Document 1). The spacer for radiation therapy described in Patent Document 1 is composed of a silicone balloon body, and is inserted between the affected area and the normal tissue before radiation therapy. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Japanese Patent Application Publication No. 62-55599 Summary of the Invention [Problem to be solved by the invention]

[0004] The spacer for radiotherapy is removed from the patient's body after radiotherapy. Removing the spacer for radiotherapy from the patient's body through a second surgery after radiotherapy places a heavy burden on the patient. Therefore, a spacer for radiotherapy that can reduce the burden on the patient is desired.

[0005] An object of the present invention is to provide a spacer for radiotherapy and a spacer delivery system that can reduce the burden on the patient. [Means for solving the problem]

[0006] The present invention relates to a spacer for radiotherapy comprising a balloon portion having a balloon body capable of sealing a fluid therein, a communication flow path connecting the inside and outside of the balloon body, and a closing portion that closes the communication flow path, wherein the balloon portion is made of a biodegradable material.

[0007] Preferably, the closure is made of a biodegradable material.

[0008] Furthermore, it is preferable that the balloon portion be formed in a flat shape when no fluid is sealed inside.

[0009] Moreover, the balloon portion preferably has a partition portion that partitions the inside of the balloon portion.

[0010] It is also preferable that the closing portion allows fluid to flow from the outside to the inside of the balloon portion and prohibits fluid from flowing from the inside to the outside of the balloon portion.

[0011] The present invention also relates to a spacer delivery system for placing a radiotherapy spacer inside a living body, comprising: a fluid injection tube having a balloon portion attached to its tip; an outer tube capable of accommodating the balloon portion and the fluid injection tube inside, with the balloon portion and the fluid injection tube arranged in this order from the tip side; and a pusher member arranged between the fluid injection tube and the outer tube behind the balloon portion, and capable of pushing the balloon portion out from the tip side of the outer tube. [Effects of the Invention]

[0012] According to the present invention, it is possible to provide a spacer for radiotherapy and a spacer delivery system that can reduce the burden on the patient. [Brief explanation of the drawings]

[0013] [Figure 1] FIG. 2 is a perspective view showing a state in which a fluid is sealed inside the spacer for radiotherapy according to the first embodiment. [Figure 2] FIG. 1 is a perspective view showing a state in which no fluid is injected into the spacer for radiotherapy. [Figure 3] FIG. 10 is a perspective view showing the radiation treatment spacer in a rolled state. [Figure 4] FIG. 10 is a diagram showing a state in which a radiotherapy spacer is rolled up and housed in a spacer delivery system. [Figure 5] FIG. 10 is a diagram showing the state in which a radiotherapy spacer is pushed out from the tip of the spacer delivery system. [Figure 6] 10A and 10B are diagrams showing a state in which a fluid is injected into a radiotherapy spacer extruded from the tip of the spacer delivery system. [Figure 7] 10 is a diagram showing a state in which a fluid injection tube is pulled out from the spacer for radiotherapy after a fluid is injected into the spacer for radiotherapy. FIG. [Figure 8] FIG. 10 is a perspective view showing a spacer for radiotherapy according to a second embodiment. [Figure 9] FIG. 10 is a perspective view showing a spacer for radiotherapy according to a third embodiment. [Figure 10] FIG. 10 is a perspective view showing a spacer for radiotherapy according to a fourth embodiment. [Figure 11A] FIG. 10 is a diagram showing an example of a state in which a fluid is injected into the balloon portion of the spacer for radiotherapy in use. [Figure 11B] 10 is a diagram showing an example of a state in which the communication fluid flow path is closed by a closing portion in a state in which the spacer for radiotherapy is used. FIG. [Figure 12] 10 is a diagram showing a state in which the communication fluid flow path is closed by the closing portion in another example of the usage state of the spacer for radiotherapy. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0014] A first embodiment of the present invention will be described below with reference to the drawings. A spacer for radiotherapy 1 according to the present invention is inserted between the affected area (tumor) and normal tissue of a patient during radiotherapy to protect the normal tissue surrounding the affected area from radiation exposure.

[0015] 1, the spacer for radiotherapy 1 includes a balloon portion 2 having a communicating fluid flow path 3, and a closing portion 4. In this embodiment, the closing portion 4 is configured by at least a part of the communicating fluid flow path 3.

[0016] The balloon portion 2 is formed in a bag shape. The balloon portion 2 can be filled with a fluid F. The balloon portion 2 is placed (disposed) between the affected area and normal tissue in an expanded state with the fluid F filled therein.

[0017] The balloon portion 2 has a balloon body 21, a plurality of partition joints 22 (partitions), and a communicating fluid flow path 3 (communicating flow path). The balloon body 21 is formed, for example, by joining the peripheries of two rectangular sheets, with the interior of the balloon body 21 partitioned by the plurality of partitions 22 and with the communicating fluid flow path 3 provided. As shown in Fig. 2, the balloon portion 2 is formed in a flat shape when no fluid F is sealed inside.

[0018] The two sheets constituting the balloon body 21 are formed, for example, with a length in the long side direction of 30 to 250 mm and a width in the short side direction of 30 to 250 mm, and by containing fluid F inside, the balloon body 21 can be inflated, for example, to a thickness of about 5 to 30 mm, as shown in Fig. 1. Before fluid F is injected inside, the balloon body 21 is formed in a rectangular shape in a plan view, as shown in Fig. 2, and is formed in the shape of a sheet with a thickness of, for example, about 1 mm.

[0019] Because the balloon body 21 is formed in a sheet shape, the balloon portion 2 can be rolled or folded, for example, as shown in Fig. 3, to reduce the size of the balloon portion 2 to a size that can easily pass through the inside of a tubular member such as a trocar used in laparoscopic surgery. By rolling or folding the balloon portion 2, for example, a spacer delivery system 5 (described later) can be used to make an incision of 1 cm to 2 cm in the abdominal wall of a patient, insert the spacer for radiotherapy 1 through the small incision, and easily place the spacer for radiotherapy 1 between the affected area and normal tissue.

[0020] The communicating fluid flow path 3 is formed in a cylindrical shape and communicates between the inside and outside of the balloon portion 2. The fluid F injected into the balloon portion 2 flows through the communicating fluid flow path 3. As shown in FIGS. 1 and 2 , the communicating fluid flow path 3 is formed in a cylindrical shape extending along the short direction of the balloon body 21 at the center of one long side of the balloon body 21. One end of the communicating fluid flow path 3 is located inside the balloon body 21, and the other end is located outside the balloon body 21. The communicating fluid flow path 3 may be located at a position other than the center of one long side of the balloon body 21. The other end of the communicating fluid flow path 3 may also be located inside the balloon body 21.

[0021] The closure unit 4 closes the communicating fluid flow path 3. In this embodiment, the closure unit 4 is provided in the communicating fluid flow path 3 and is configured by at least a part of the communicating fluid flow path 3. The closure unit 4 allows the fluid F to flow from the outside to the inside of the balloon portion 2 and prohibits the fluid F from flowing out from the inside to the outside of the balloon portion 2.

[0022] The closure unit 4 is configured so that the communicating fluid flow path 3 is collapsed without any gaps except when the fluid is passing through, so that after the fluid is injected into the balloon portion 2 through the communicating fluid flow path 3, the fluid does not flow back from the inside of the balloon portion 2 to the outside. In this embodiment, the closure unit 4 is formed in a collapsed tube shape when closed. As a result, when the fluid injection tube 52 is inserted into the communicating fluid flow path 3, the fluid F can be injected into or sucked out of the balloon portion 2 via the fluid injection tube 52. After the fluid F is injected into the balloon portion 2, the fluid injection tube 52 is removed from the communicating fluid flow path 3, and the communicating fluid flow path 3 is closed by the collapsed closure unit 4. By using the fluid injection tube 52 in the closure unit 4 to inject or suck out the fluid F from the inside of the balloon portion 2, the fluid F can be introduced into or extracted from the inside of the balloon portion 2. This allows the amount of fluid F injected into the balloon portion 2 to be adjusted.

[0023] In this embodiment, the closing section 4 is formed in a shape in which the tube is collapsed when closed, but is not limited to this. In addition to the closing section 4 of this embodiment, a one-way valve such as a duckbill valve formed in the shape of a bird's beak (duckbill) or a seat valve with a valve seat can be used as a configuration that allows the fluid F to flow from the outside to the inside of the balloon section 2 and prevents the fluid F from flowing from the inside to the outside of the balloon section 2.

[0024] As shown in FIG. 3 , for example, a fluid injection tube 52 is inserted into the balloon body 21 through the communicating fluid flow path 3. A fluid F is injected into or sucked out of the balloon body 21 via the fluid injection tube 52. The fluid F injected into the balloon portion 2 is one that does not harm the human body even if it remains in the body, and examples of the fluid F include liquids such as water, saline, or mixed solutions, gases such as air, oxygen, or nitrogen, and gel-like substances. Furthermore, the liquid may be mixed with a mixed substance to enhance the radiation attenuation effect during radiation therapy, or the fluid may be colored to make it easier to identify.

[0025] 1 and 2, the multiple compartment joints 22 divide the interior of the balloon portion 2. In this embodiment, the multiple compartment joints 22 are formed on the interior side of the balloon body 21 by joining parts of two sheets that make up the balloon body 21.

[0026] The multiple compartment joints 22 extend linearly along the short side of the balloon portion 2 at two locations midway along the longitudinal direction of the balloon portion 2, so as to divide the interior of the balloon portion 2 into multiple sections in the longitudinal direction of the balloon portion 2. The compartment joints 22 extend from one long side of the balloon portion 2 to just before the other long side.

[0027] The interior of the balloon portion 2 is partitioned over most of its widthwise direction into multiple compartments 211a, 211b, and 211a by multiple compartment joints 22. The multiple compartments 211a, 211b, and 211a are arranged at predetermined intervals in the longitudinal direction of the balloon portion 2 and extend in the widthwise direction of the balloon portion 2. The multiple compartments 211a, 211b, and 211a include end compartments 211a and 211a arranged at both ends of the balloon portion 2 in the longitudinal direction, and an intermediate compartment 211b arranged in the middle of the balloon portion 2 in the longitudinal direction.

[0028] A communication passage 212 that connects adjacent compartments 211a, 211b, 211a is formed in a part of the other end side in the short side direction of the balloon portion 2. The communication passage 212 allows the movement of fluid F between the multiple compartments 211a, 211b, 211a inside the balloon portion 2.

[0029] The fluid F injected into the balloon portion 2 through the fluid injection tube 52 and the communicating fluid flow path 3 fills the middle compartment 211b of the balloon portion 2, passes through the middle compartment 211b, and flows through the communicating path 212 to fill the end compartments 211a, 211a. The fluid F filled in the multiple compartments 211a, 211b, 211a is sealed inside the balloon portion 2 in a state where it can move between them via the communicating path 212.

[0030] 1, when the fluid F is contained inside the balloon portion 2, the balloon portion 2 is inflated by containing the fluid F in the multiple compartments 211a, 211b, 211a, and multiple bulging portions 23 are formed. The balloon portion 2 is easily bent because the thickness of the multiple compartment joints 22 is smaller than that of the multiple bulging portions 23.

[0031] When the spacer for radiotherapy 1 is placed between the affected area and normal tissue and the balloon portion 2 is inflated with the fluid F contained inside, a space can be secured between the affected area and normal tissue. As a result, during radiotherapy, even if high-intensity radiation is irradiated to the affected area, the space formed by the spacer for radiotherapy 1 can attenuate the radiation, thereby minimizing the effects of the radiation on normal tissue.

[0032] While the spacer for radiotherapy 1 is placed inside the patient's body, the spacer for radiotherapy 1 can be fixed to internal organs or tissues. One example of a fixing method is to suture the edges of the spacer for radiotherapy 1 to the organ or tissue. Providing suture holes on the edges of the spacer for radiotherapy 1 simplifies the suturing procedure. Other fixing methods include, for example, fixing the spacer for radiotherapy 1 to the internal organ or tissue with a clip made of a biodegradable material, roughening the surface of the spacer for radiotherapy 1 to prevent it from moving from its placement location inside the body, or adhering the surface of the spacer for radiotherapy 1 to the internal organ or tissue with fibrin glue or the like.

[0033] In the above-described spacer for radiotherapy 1, the balloon portion 2 and the closing portion 4 are made of a biodegradable material. Examples of materials that can be used for the balloon portion 2 and the closing portion 4 include biodegradable materials such as polylactic acid (PLA), polycaprolactone (PCL), polyglycolic acid (PGA), and polydioxanone (PDO), as well as copolymers and mixtures of these biodegradable materials. In this embodiment, the entire spacer for radiotherapy 1 is made of a biodegradable material.

[0034] Because the balloon portion 2 and the closing portion 4 are made of a biodegradable material, the balloon portion 2 and the closing portion 4 degrade over time within the patient's body. By making the balloon portion 2 and the closing portion 4 from a biodegradable material, they degrade, for example, over a period of about two weeks to six months. For example, assuming that radiotherapy is performed as an outpatient procedure for about four weeks, the balloon portion 2 and the closing portion 4 made of a biodegradable material preferably degrade over a period of about four to eight weeks. Because the balloon portion 2 and the closing portion 4 made of a biodegradable material degrade over time, it is not necessary to remove the radiotherapy spacer 1 from the patient's body after it has been placed therein. Therefore, by making the balloon portion 2 and the closing portion 4 from a biodegradable material, surgery to remove the radiotherapy spacer 1 from the patient's body is not required, thereby reducing the burden on the patient.

[0035] Next, a method for placing the spacer for radiotherapy 1 between the affected area and normal tissue of a patient using the spacer delivery system 5 will be described. The spacer delivery system 5 is used to place the spacer for radiotherapy 1 inside the patient's body (intravital tissue). In this embodiment, the end of the outer tube 51 of the spacer delivery system 5 where the spacer for radiotherapy 1 is placed is referred to as the tip side, and the side opposite to the tip side of the outer tube 51 of the spacer delivery system 5 is referred to as the rear side.

[0036] The spacer delivery system 5 can, for example, make a 1-2 cm incision in the patient's abdominal wall, deliver the radiotherapy spacer 1 between the affected area and normal tissue, and place it there, and can also inflate the radiotherapy spacer 1 placed between the affected area and normal tissue by injecting a fluid F into it.

[0037] First, as shown in Fig. 4, before placing the spacer for radiotherapy 1 between the affected area and normal tissue of a patient using a spacer delivery system 5, the spacer for radiotherapy 1 is set in advance at the tip of the outer cylinder 51 of the spacer delivery system 5. As shown in Fig. 4, the spacer delivery system 5 has the outer cylinder 51, a fluid injection tube 52 arranged inside the outer cylinder 51, and an intermediate cylinder 53 (push member) arranged between the fluid injection tube 52 and the outer cylinder 51.

[0038] The outer cylinder 51 can accommodate the balloon portion 2 and the fluid injection tube 52 inside. The balloon portion 2 is attached to the tip of the fluid injection tube 52. The balloon portion 2 and the fluid injection tube 52 are arranged in this order on the outer cylinder 51 from the tip side. The intermediate cylinder 53 is arranged between the fluid injection tube 52 and the outer cylinder 51 on the rear side of the balloon portion 2. The intermediate cylinder 53 can push the balloon portion 2 out from the tip side of the outer cylinder 51.

[0039] When setting the radiotherapy spacer 1 in the spacer delivery system 5, as shown in Figure 3, the tip of the fluid injection tube 52 is inserted into the communicating fluid flow path 3 of the radiotherapy spacer 1, and the balloon portion 2 is, for example, rolled or folded, and placed inside the tip side of the outer tube 51 as shown in Figure 4.

[0040] The intermediate cylinder 53 is disposed on the rear side of the spacer for radiotherapy 1 between the fluid injection tube 52 and the outer cylinder 51. The intermediate cylinder 53 is configured to be movable toward the distal end side relative to the outer cylinder 51.

[0041] When the radiotherapy spacer 1 is to be placed inside the patient's body, the spacer delivery system 5, in which the radiotherapy spacer 1 is set at the tip inside the outer tube 51, is used to deliver the tip of the outer tube 51 between the patient's affected area and normal tissue, for example, through a 1-2 cm incision in the patient's abdominal wall.

[0042] Next, after the tip of the outer cylinder 51 has been advanced to the affected area, as shown in Fig. 5, the intermediate cylinder 53 and the fluid injection tube 52 are moved toward the outside of the tip of the outer cylinder 51 so as to push out the spacer for radiotherapy 1 inserted into the tip of the fluid injection tube 52 from the tip of the outer cylinder 51. In this way, the spacer for radiotherapy 1, which is arranged in a rolled state inside the tip side of the outer cylinder 51, can be pushed out from the tip of the outer cylinder 51.

[0043] Then, with the radiotherapy spacer 1 pushed out from the tip of the outer tube 51, as shown in Fig. 6, a fluid F is injected into the balloon portion 2 via the fluid injection tube 52 and the communicating fluid flow path 3. By injecting the fluid F into the balloon portion 2, the balloon portion 2 is inflated between the affected area and normal tissue.

[0044] 1, the balloon portion 2 is placed between the affected area and normal tissue, separated by multiple compartment junctions 22. In its inflated state, the balloon portion 2 can be bent at the compartment junctions 22, which have a small thickness. Therefore, the multiple compartments 211a, 211b, 211a separated by the compartment junctions 22 fit the area where the balloon portion 2 is placed, thereby reducing excess pressure on the area where the balloon portion 2 is placed.

[0045] Next, from the state shown in Fig. 6, by moving the fluid injection tube 52 rearward, the tip of the fluid injection tube 52 inserted into the communicating fluid flow path 3 is withdrawn from the communicating fluid flow path 3. In this case, as shown in Fig. 7, the closure unit 4 of the communicating fluid flow path 3 prevents the fluid F from flowing out from the inside of the balloon portion 2 to the outside. As a result, simply by withdrawing the fluid injection tube 52 from the balloon portion 2, the closure unit 4 can easily close the communicating fluid flow path 3 of the balloon portion 2. In this state, radiation therapy is performed.

[0046] After the radiation therapy is completed, the spacer for radiotherapy 1 does not need to be removed from the abdominal cavity. More specifically, because the balloon portion 2 and the communicating fluid channel 3 are made of a biodegradable material, the spacer for radiotherapy 1 decomposes over time in the abdominal cavity. Therefore, after the spacer for radiotherapy 1 is placed inside the patient's body, it does not need to be removed from the patient's body.

[0047] The spacer for radiotherapy 1 according to this embodiment has the following advantages.

[0048] The spacer for radiotherapy 1 of this embodiment is configured to include a balloon body 21, a balloon portion 2 having a communicating fluid flow path 3 that connects the inside and outside of the balloon body 21, and a closing portion 4 that closes the communicating fluid flow path 3, and the balloon portion 2 is formed from a biodegradable material. As a result, the balloon portion 2 is degraded inside the patient's body, so there is no need to remove the balloon portion 2 from the patient's body after the spacer for radiotherapy 1 is placed inside the patient's body. This reduces the burden on the patient.

[0049] Furthermore, in this embodiment, the closing part 4 is made of a biodegradable material. As a result, when the balloon part 2 and the closing part 4 are placed inside the patient's body, both the balloon part 2 and the closing part 4 are degraded inside the patient's body, so there is no need to remove the balloon part 2 and the closing part 4 from the patient's body. This further reduces the burden on the patient.

[0050] Furthermore, in this embodiment, the balloon portion 2 is formed in a flat shape when the fluid F is not sealed therein. This allows the balloon portion 2 to be rolled or folded, for example, and then delivered into the patient's body through a small incision in the patient's abdominal wall, for example, via the outer tube 51 of the spacer delivery system 5. Therefore, laparotomy is not required when placing the radiotherapy spacer 1 inside the patient's body, thereby reducing the burden on the patient. Furthermore, the radiotherapy spacer 1 is formed into a balloon shape by including the balloon portion 2. This allows the radiotherapy spacer 1 to be formed into a balloon shape by greatly inflating it using a small amount of biodegradable material. Therefore, the amount of biodegradable material used can be reduced compared to, for example, using a sponge-like radiotherapy spacer made of a biodegradable material. This allows for a small amount of biodegradable material to be decomposed in the patient's body, thereby suppressing inflammation in the patient's body.

[0051] Furthermore, in this embodiment, the balloon portion 2 has a plurality of compartment junctions 22 that divide the interior of the balloon portion 2. As a result, the balloon portion 2 is placed between the affected area and normal tissue in a state divided by the plurality of compartment junctions 22. The balloon portion 2 can be bent at the compartment junctions 22. Therefore, the plurality of compartments 211a, 211b, 211a divided by the compartment junctions 22 in the balloon portion 2 can be fitted to the area where the balloon portion 2 is placed, thereby reducing excess pressure applied to the area where the balloon portion 2 is placed.

[0052] Furthermore, in this embodiment, the closure unit 4 allows the fluid F to flow from the outside to the inside of the balloon portion 2, while prohibiting the fluid F from flowing out from the inside of the balloon portion 2 to the outside. This prevents the fluid F from flowing out from the inside of the balloon portion 2 while the fluid F is being injected into the inside of the balloon portion 2, making it possible to easily inject the fluid F into the inside of the balloon portion 2. Furthermore, after the fluid F has been easily injected into the inside of the balloon portion 2, the communicating fluid flow path 3 of the balloon portion 2 can be easily closed by simply pulling out the fluid injection tube 52 from the balloon portion 2.

[0053] The spacer delivery system 5 also includes a fluid injection tube 52 having a balloon portion 2 attached to its tip, an outer tube 51 capable of accommodating the balloon portion 2 and the fluid injection tube 52 inside and in which the balloon portion 2 and the fluid injection tube 52 are arranged in this order from the tip side, and an intermediate tube 53 arranged between the fluid injection tube 52 and the outer tube 51 behind the balloon portion 2 and capable of pushing out the balloon portion 2 from the tip side of the outer tube 51. As a result, the spacer for radiotherapy 1 can be easily placed inside the patient's body by pushing out the balloon portion 2 with the intermediate tube 53 and injecting a fluid F into the balloon portion 2 with the fluid injection tube 52.

[0054] Next, a second embodiment will be described. As shown in Fig. 8, a radiotherapy spacer 1A of the second embodiment differs in that it includes two partition members 25, whereas the first embodiment includes a partition joint 22. In the second embodiment, the same components as those in the first embodiment are denoted by the same reference numerals, and the description thereof will be omitted.

[0055] The spacer for radiotherapy 1A of the second embodiment includes two partitioning members 25 (partitioning sections). The two partitioning members 25 press part of the outer surface of the balloon section 2 to partition the interior of the balloon section 2 into multiple partitioning sections 213a, 213b, 213a. The partitioning members 25 are formed in a narrow, elongated ring shape. The two partitioning members 25 are arranged around the balloon body 21 along the short side direction of the balloon section 2 at two locations midway along the longitudinal direction of the balloon section 2.

[0056] The multiple partitions 213a, 213b, 213a are formed side by side in the longitudinal direction of the balloon portion 2 and extend in the lateral direction of the balloon portion 2. The multiple partitions 213a, 213b, 213a include end partitions 213a, 213a arranged at both ends of the balloon portion 2 in the longitudinal direction, and a middle partition 213b arranged in the middle of the balloon portion 2 in the longitudinal direction.

[0057] In this embodiment, the two partition members 25 do not completely press down the two sheets that make up the balloon body 21 at their narrow portions, but rather allow the fluid F to move between the multiple partition portions 213a, 213b, 213a inside the balloon portion 2.

[0058] The two partitioning members 25 are made of a biodegradable material. As a result, similar to the first embodiment, they are degraded inside the patient's body, so there is no need to remove the spacer for radiotherapy 1A from the patient's body after it has been placed inside the patient's body. This reduces the burden on the patient.

[0059] In the second embodiment, the partition is formed by the partition member 25 that surrounds the balloon portion 2, but this is not limiting. The partition may be formed by a U-shaped partition member that does not surround the balloon portion 2, for example, one end of which is open.

[0060] A third embodiment will now be described. As shown in Fig. 9, a radiotherapy spacer 1B of the third embodiment differs from the radiotherapy spacer 1A of the first embodiment in that the spacer 1A is provided with a closure portion 4 constituted by at least a part of the communicating fluid flow path 3, whereas the closure portion is constituted by a plug member 4A that closes the communicating fluid flow path 3 by plugging it. In the third embodiment, components similar to those in the first embodiment are designated by the same reference numerals, and descriptions thereof will be omitted.

[0061] In the spacer for radiotherapy 1B of the third embodiment, the closing portion is configured by a plug member 4A that closes the communicating fluid flow path 3. The plug member 4A of the third embodiment is an example of the closing portion. The plug member 4A closes the communicating fluid flow path 3 by plugging the communicating fluid flow path 3.

[0062] The plug member 4A is made of a biodegradable material. As a result, as in the first embodiment, the plug member 4A decomposes inside the patient's body, so after the spacer for radiotherapy 1B is placed inside the patient's body, it is not necessary to remove the spacer for radiotherapy 1B from the patient's body. This reduces the burden on the patient.

[0063] A fourth embodiment will now be described. As shown in Fig. 10, a radiotherapy spacer 1C of the fourth embodiment differs from the radiotherapy spacer 1 of the first embodiment in that, while the radiotherapy spacer 1 is provided with a closure portion 4 constituted by at least a part of the communicating fluid flow path 3, the closure portion is constituted by a clip member 4B that closes the communicating fluid flow path 3 by clamping it. In the fourth embodiment, components similar to those of the first embodiment are designated by the same reference numerals, and descriptions thereof will be omitted.

[0064] In the spacer for radiotherapy 1C of the fourth embodiment, the closing section is configured by a clip member 4B that closes the communicating fluid flow path 3. The clip member 4B closes the communicating fluid flow path 3 by clamping it in the middle of the communicating fluid flow path 3 outside the spacer for radiotherapy 1C along a direction intersecting the axis of the communicating fluid flow path 3.

[0065] The clip member 4B is made of a biodegradable material. As a result, as in the first embodiment, the clip member 4B decomposes inside the patient's body, so after the spacer for radiotherapy 1C is placed inside the patient's body, it is not necessary to remove the spacer for radiotherapy 1C from the patient's body. This reduces the burden on the patient.

[0066] Next, an example of how the spacer for radiotherapy is used will be described. As shown in Fig. 11A, when the spacer for radiotherapy 1D is placed inside the body of a patient 10, the spacer for radiotherapy 1D is fed through an incision in the abdominal wall 11 of the patient 10 and placed between an affected area 12 and normal tissue 13. In this state of use, a communicating fluid flow path 3A (communicating flow path) that communicates with the interior of the balloon portion 2 extends from the interior of the balloon portion 2 placed inside the body of the patient 10 to the outside of the body of the patient 10. A closure portion 4C is provided at the end of the communicating fluid flow path 3A on the inside side of the balloon portion 2.

[0067] In this state, as shown in FIG. 11A, a fluid injection tube 52 is passed through the inside of the communicating fluid flow path 3A, and the fluid F is injected into the inside of the balloon portion 2 or sucked out from the inside of the balloon portion 2 using the fluid injection tube 52, thereby adjusting the amount of fluid F injected into the inside of the balloon portion 2 and inflating the balloon portion 2 between the affected area 12 and the normal tissue 13.

[0068] After injecting the fluid F into the balloon portion 2, the fluid injection tube 52 is pulled out from the communicating fluid flow path 3A, whereby the closing unit 4C provided at the end of the communicating fluid flow path 3A on the inside side of the balloon portion 2 closes the communicating fluid flow path 3A inside the balloon portion 2, as shown in Fig. 11B. In this state, radiation therapy is performed.

[0069] 11B, a spacer for radiotherapy 1E may be used, and a closure 4D may be provided in a portion of the communicating fluid flow path 3A that is located outside the body of the patient 10, as in another example of a usage state of a spacer for radiotherapy shown in Fig. 12. In this case, the communicating fluid flow path 3A can be closed by the closure 4D provided in the portion of the communicating fluid flow path 3A that is located outside the body of the patient 10.

[0070] According to this example of usage, the communicating fluid flow path 3A is configured to have a length that extends to the outside of the body of the patient 10. As a result, when performing multiple radiation treatments over a predetermined period (for example, four weeks), the fluid F can be injected to inflate the balloon portion 2 before radiation irradiation (pre-treatment), and the fluid F can be sucked out to deflate the balloon portion 2 after radiation irradiation has finished (post-treatment). Therefore, during radiation treatment over a predetermined period, the balloon portion 2 can be deflated when radiation irradiation is not being performed, thereby reducing pressure on the internal organs of the patient 10 caused by the radiation therapy spacer placed inside the body and alleviating the burden on the patient 10.

[0071] Although the preferred embodiments of the spacers for radiotherapy 1, 1A, 1B, 1C, 1D, and 1E of the present invention have been described above, the present invention is not limited to the above-described embodiments and can be modified as appropriate.

[0072] For example, in the above embodiment, the spacer for radiotherapy 1 is placed between the affected area and normal tissue of the patient by the spacer delivery system 5, but this is not limiting. The spacer for radiotherapy 1 may also be placed between the affected area and normal tissue of the patient by laparotomy. In this case, too, the balloon portion 2 and the closure portion 4 are made of biodegradable materials, so the spacer for radiotherapy 1 does not need to be removed from the patient's body.

[0073] In the above embodiment, the communicating fluid flow path 3 is formed in a cylindrical shape, but is not limited to this. The communicating fluid flow path 3 may be formed as a simple opening that communicates between the inside and outside of the balloon portion 2.

[0074] In the above embodiment, the balloon portion 2 is formed in a rectangular shape in plan view, but is not limited to this. The balloon portion may be formed in a circular or elliptical shape in plan view.

[0075] In the above embodiment, the closing portion may or may not be made of a biodegradable material. [Explanation of symbols]

[0076] 1, 1A, 1B, 1C, 1D, 1E Radiation Therapy Spacer 2 Balloon section 3. Connecting fluid flow path (connecting flow path) 4 Closure 5 Spacer Delivery System 21 Balloon body 22 Compartment joint (compartment) 25 Partitioning member (partitioning section) 51 Outer cylinder 52 Fluid injection tube 53 Intermediate cylinder (push member) F fluid

Claims

1. a balloon portion having a balloon body capable of sealing a fluid therein and a cylindrical communication flow path that communicates the inside and outside of the balloon body; a closing portion that closes the communication flow path, the balloon portion has a partition portion that partitions the inside of the balloon portion, the partitioning portions are disposed apart from the communicating flow path in a direction perpendicular to the direction in which the communicating flow path extends, and are formed to extend parallel to the direction in which the communicating flow path extends, and partition the interior of the balloon portion into a plurality of portions in a direction perpendicular to the direction in which the partitioning portions extend, The balloon portion of the spacer for radiotherapy is formed from a biodegradable material.

2. The spacer for radiotherapy according to claim 1 , wherein the closing portion is made of a biodegradable material.

3. 3. The spacer for radiotherapy according to claim 1, wherein the balloon portion is formed in a flat shape when no fluid is sealed inside.

4. 4. A spacer for radiotherapy according to claim 1, wherein the closing portion allows fluid to flow from the outside of the balloon portion to the inside thereof and prohibits fluid from flowing from the inside of the balloon portion to the outside thereof.

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