WO2015099089A1 - 体内埋込スペーサー - Google Patents
体内埋込スペーサー Download PDFInfo
- Publication number
- WO2015099089A1 WO2015099089A1 PCT/JP2014/084410 JP2014084410W WO2015099089A1 WO 2015099089 A1 WO2015099089 A1 WO 2015099089A1 JP 2014084410 W JP2014084410 W JP 2014084410W WO 2015099089 A1 WO2015099089 A1 WO 2015099089A1
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- WO
- WIPO (PCT)
- Prior art keywords
- tube
- thread
- spacer
- fixing
- trigger
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
- A61N2005/1085—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy characterised by the type of particles applied to the patient
- A61N2005/1087—Ions; Protons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
- A61N2005/1092—Details
- A61N2005/1094—Shielding, protecting against radiation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
- A61N2005/1092—Details
- A61N2005/1096—Elements inserted into the radiation path placed on the patient, e.g. bags, bolus, compensators
Definitions
- the present invention relates to an implantable spacer.
- Particle beam therapy is a treatment method in which cells such as malignant tumors are killed by irradiating malignant tumors or the like with particle beams such as heavy particles.
- particle beam therapy surrounding normal organs such as malignant tumors may be damaged by irradiating the surrounding normal organs such as malignant tumors with the particle beam.
- a spacer is embedded between the tumor and normal tissue.
- FIG. 1 is a diagram showing an example of a spacer embedded between a tumor in a body and a normal organ or the like.
- a spacer is embedded between a tumor and a normal organ or the like.
- the particle beam is irradiated with respect to the tumor from the outside of the body.
- the size of the irradiation field which is the range irradiated with the particle beam, is larger than the size of the tumor.
- an artifact such as Gore-Tex is used as a spacer to fill the space created between the tumor and the intestinal tract (digestive tract).
- Artifacts as spacers are implanted in the body by laparotomy before particle beam irradiation. Since an artificial object is a foreign body for the body, it is required to be removed from the body after treatment. When removing an artificial object after treatment, it is required to perform a laparotomy again. Since laparotomy is a burden on the patient, it is required to reduce the number of times of laparotomy.
- the present invention employs the following means in order to solve the above problems. That is, the first aspect is Tubes that are folded or folded at one or more locations to form mutually adjacent partial sections; In order to maintain the shape of the tube, a fixing thread provided along a direction crossing the partial section; An in-vivo spacer is provided with a trigger thread for locking the fixed thread in a releasable state.
- an in-vivo implantable spacer that can be placed in the body and can be easily removed after placement.
- FIG. 1 is a diagram illustrating an example of a spacer embedded between a tumor and a normal organ or the like.
- FIG. 2 is a diagram illustrating a configuration example of the spacer.
- FIG. 3 is a diagram showing an example of a spacer tube.
- FIG. 4 is a diagram illustrating an example of a tube folded at a folded portion.
- FIG. 5 is a diagram illustrating an example of the first fixed yarn.
- FIG. 6 is a diagram illustrating an example of a position where the first fixing thread is passed through the tube.
- FIG. 7 is a view showing an example in which the first fixing thread is passed through the central portion of the tube.
- FIG. 8 is a diagram showing an example in which two sets of fixing yarns are passed through the central portion of the tube.
- FIG. 1 is a diagram illustrating an example of a spacer embedded between a tumor and a normal organ or the like.
- FIG. 2 is a diagram illustrating a configuration example of the spacer.
- FIG. 9 is a diagram illustrating an example in which the second fixing yarn is passed through the first fixing yarn.
- FIG. 10 is a diagram illustrating a position where the trigger thread is passed.
- FIG. 11 is a diagram illustrating an example in which the trigger thread is passed through the second fixed thread.
- FIG. 12 is a diagram illustrating an example of the first knot and the second knot.
- FIG. 13 is a diagram showing an example of a cross-sectional view of the central portion of the tube in the state of FIG.
- FIG. 14 is a diagram illustrating an example of a spacer production tool.
- FIG. 15 is a diagram showing an example of use of the spacer production tool of FIG.
- FIG. 16 is a diagram illustrating a configuration example of the spacer according to the first modification.
- FIG. 17 is a diagram illustrating a configuration example of the spacer according to the second modification.
- FIG. 2 is a diagram illustrating a configuration example of the spacer according to the present embodiment.
- the spacer 1 in FIG. 2 includes a tube 10, a first fixing thread 21, a second fixing thread 22, and a trigger thread 30.
- a set of one first fixing thread 21 and one second fixing thread 22 is collectively referred to as a fixing thread 20.
- the spacer 1 includes two sets of fixing threads 20, but the spacer 1 may include two or more sets of fixing threads 20.
- the spacer 1 includes one trigger thread, but the spacer 1 may include a plurality of trigger threads 30.
- a dotted line in the first fixed yarn 21 or the second fixed yarn 22 means that the first fixed yarn 21 or the second fixed yarn 22 passes through the back side of the tube 10.
- the tube 10 has elasticity and is bent back multiple times. As the tube 10 is folded back multiple times, the folded portions of the tube 10 approach or are adjacent to each other to form a corrugated structure.
- a partial section formed by folding the tube 10 is simply referred to as a partial section.
- the corrugated structure excluding both ends of the tube 10 will be referred to as a planar portion of the tube 10.
- the corrugated structure can also be called a bowl shape.
- the tube 10 may be bent at least once to form an adjacent partial section.
- the tube 10 may be bent at one or a plurality of locations to form adjacent partial sections.
- the tube 10 may include both a folded portion and a folded portion.
- the fixing thread 20 is one surface of the planar portion with respect to an adjacent partial section of the tube 10 that is folded back in the direction crossing the tube 10 along the outer surface of the tube 10 in the planar portion of the tube 10.
- the front side (front side) and the back side viewed from above are passed through alternately so as to fix the shape of the planar portion of the tube 10.
- the first fixing thread 21 and the second fixing thread 22 are passed through the planar portion so as to come into contact with the opposite surfaces of the outer surface of the tube 10 with respect to the partial section.
- the first fixed yarn 21 and the second fixed yarn 22 are folded at one end, and a loop is formed at the folded portion, and two sets of yarns having a loop as a tip, that is, a double line shape, a surface Threaded part.
- the loop at the tip of the second fixing yarn 22 is passed through the loop at the tip of the first fixing yarn 21, whereby the first The leading end of the fixing thread 21 is locked to the second fixing thread 22.
- the loop at the tip of the second fixed yarn 22 is locked to the trigger yarn 30 at a position further extended from the partial section of the tube 10 at one end of the planar portion.
- the trigger yarn 30 is passed through the loop at the tip of the second fixed yarn 22 that is extended from one end of the planar portion.
- the trigger thread 30 and the second fixed thread 22 are locked.
- the two sets of yarns of the second fixed yarn 22 are further folded to form a loop in each of the two sets of yarns, and the trigger yarn 30 is passed through each loop. You may do it.
- the locking is released by pulling out the trigger thread 30.
- the locking of the first fixed thread 21 and the second fixed thread 22 can be released.
- the locking of the first fixed thread 21 and the second fixed thread 22 is released.
- the fixing of the shape of the tube 10 is released.
- a section of the tube 10 at the end on the other side (referred to as the second side) with respect to the side (referred to as the first side) where the fixing thread 20 is locked by the trigger thread 30 in the planar portion.
- the first fixing thread 21 and the second fixing thread 22 are tied between the partial section adjacent to the partial section (the second partial section from the end on the second side), and the first knot is created. It is done.
- the first side portion and the second side portion are side portions on both sides of the planar portion.
- the first fixed yarn 21 and the second fixed yarn 22 are tied so that the tube 10 and the trigger yarn 30 are not easily detached. Further, the first fixing yarn 21 and the second fixing yarn 22 that have come out of the first knot are turned outside the partial section of the tube 10 at the end of the second side portion, and the first fixing yarn 21 and the second fixing yarn 22 Is tied and a second knot is made. Note that there is no limitation on how to tie the first knot and the second knot.
- the fixing thread 20 is fixed to the tube at the other end of the planar portion by the first knot and the second knot. On the other hand, when the trigger thread 30 is pulled out, the first fixed thread 21 and the second fixed thread 22 are released on the trigger thread 30 side from the first knot.
- the trigger thread 30 and the tube 10, and the folded tubes 10 are separated from each other, but when the fixing thread 20 is tied tightly at the position of the first knot, The yarn 30 and the tube 10 and the folded tube 10 are in close contact with each other.
- the ellipse by the continuous line and the broken line is described in the middle of the tube 10, this is described so that it can be easily recognized that the cross section of the tube 10 is substantially circular. It does not indicate that the tube is joined or the like.
- the configuration of the spacer 1 in FIG. 2 is not limited to the example shown in FIG. 2, and components may be omitted, replaced, or added as appropriate.
- the tube 10 a tube made of a biocompatible silicon material similar to the drain used in the laparotomy is used.
- a 19Fr biocompatible silicone tube is used as the tube 10.
- the tube 10 has elasticity and can be bent.
- Other biocompatible tubes may be used as the tube 10.
- the fixing yarn 20 for example, a 4-0 nylon yarn is used.
- the trigger yarn 30 for example, No. 0 nylon yarn is used.
- the nylon thread used as the fixed thread 20 or the trigger thread 30 is a thread that can be used in a living body. Further, other biocompatible threads may be used as the fixing thread 20 or the trigger thread 30.
- the configuration of the spacer 1 will be described in detail with reference to FIGS.
- FIG. 3 is a view showing an example of the tube 10 of the spacer 1.
- the tube 10 used for the spacer 1 has portions called a first end, a center, and a second end.
- the first end is one end of the tube 10.
- the second end is the other end of the tube 10.
- the central portion is a portion between the first end portion and the second end portion.
- the central portion includes a plurality of folded portions.
- the central portion is folded back approximately 180 degrees at the folded portion.
- a part of the first end of the tube 10 is guided outside the body when the spacer 1 is implanted in the body.
- the first end is usually led out of the body about 30 to 40 cm from the end.
- the central portion of the tube 10 is folded at a plurality of folded portions. As described with reference to FIG.
- the central portion of the tube 10 is fixed by the fixing thread 20.
- the lengths of the first end, the center, and the second end of the tube 10 in FIG. 3 do not represent actual lengths.
- the lengths of the first end, the center, and the second end are appropriately changed. The same applies to the tube 10 in other figures.
- FIG. 4 is a diagram illustrating an example of the tube 10 folded at the folded portion.
- the tube 10 has a circular cross section.
- the cross-sectional circular shape means that the cross-sectional shape when the tube is cut along a plane orthogonal to the longitudinal direction of the tube is a circular shape.
- the tube 10 is folded back approximately 180 degrees at a plurality of folded portions at the center. Further, in the example of FIG. 4, the tube 10 is folded back at four locations, and in the central portion of the tube 10, partial sections of the five rows of the tubes 10 are arranged substantially in parallel to form a corrugated structure. It has a planar shape including a valley.
- the tube 10 having a circular cross section is folded at a plurality of locations, thereby forming a mountain-like structure and a valley-like structure by partial sections adjacent to each other.
- the five rows of partial sections at the center of the tube 10 are referred to as a first parallel portion, a second parallel portion, a third parallel portion, a fourth parallel portion, and a fifth parallel portion, respectively, from the side closer to the second end portion. .
- the tube 10 is folded back so as to allow ventilation between the first end portion side and the second end portion side.
- the tube 10 is not limited to a circular cross section.
- the tube 10 may have a triangular cross section, a quadrangular cross section, a pentagonal cross section, or other polygonal cross sections.
- the cross-sectional triangle shape or the like means that the cross-sectional shape when the tube is cut along a plane orthogonal to the longitudinal direction of the tube is a triangular shape or the like.
- FIG. 5 is a diagram showing an example of the first fixed yarn.
- the first fixed yarn 21 is used by being bent at one end, for example, at approximately the center of the cut yarn.
- the bent portion is a mountain folded portion, and the opposite side of the mountain folded portion is a released portion.
- the second fixing thread 22 is the same as the first fixing thread 21.
- FIG. 6 is a diagram illustrating an example of a position through which the first fixing thread is passed through the tube.
- the first fixed yarn 21 starts from the mountain-folded portion of the first fixed yarn 21, and the front side of the first parallel portion, the back side of the second parallel portion, and the front side of the third parallel portion , Passing through the back side of the fourth parallel part and the front side of the fifth parallel part.
- FIG. 7 is a view showing an example in which the first fixing thread is passed through the central portion of the tube.
- the first fixing thread 21 is passed through the central portion of the tube 10 according to the arrow 100 in FIG. 6.
- the mountain-folded portion of the first fixed yarn 21 exists on the fifth parallel portion side, and the release portion of the first fixed yarn 21 exists on the first parallel portion side.
- the first fixed yarn 21 is passed through the parallel portion of the tube 10 substantially perpendicular to the longitudinal direction of the tube.
- the dotted line in the first fixing thread 21 means that the first fixing thread 21 passes through the back side of the tube 10. The same applies to the other drawings.
- FIG. 8 is a diagram showing an example in which two sets of fixing yarns are passed through the center of the tube.
- the second fixed yarn 22 has the mountain-folded portion of the second fixed yarn 22 as the head, the back side of the first parallel part, the front side of the second parallel part, the back side of the third parallel part, the front side of the fourth parallel part, Pass the back side of the parallel part.
- the second fixed yarn 22 is passed through the parallel portion of the tube 10 substantially perpendicularly to the longitudinal direction of the tube so as to alternate with the first fixed yarn 21.
- a mountain folded portion of the second fixed yarn 22 exists on the fifth parallel portion side, and a release portion of the second fixed yarn 22 exists on the first parallel portion side.
- the fixing thread 20 (the first fixing thread 21 and the second fixing thread 22) has a mountain shape and a valley shape in the direction crossing the partial section in order to maintain the shape of the folded tube 10 more strongly. It is preferable to be provided along the structure. That is, the fixing yarn 20 is preferably attached in close contact with the outer surface of the tube.
- FIG. 9 is a diagram showing an example in which the second fixing thread is passed through the first fixing thread.
- the mountain fold portion of the second fixed yarn 22 is passed inside the mountain fold portion of the first fixed yarn 21.
- the first fixing thread 21 is locked by the second fixing thread 22.
- FIG. 10 is a diagram showing an example of a position through which the trigger thread is passed.
- the trigger thread 30 is passed through two rings formed by folding back the mountain folded portion of the second fixed thread 22.
- the second fixing yarn 22 is folded back to the back side of the drawing to form two rings (“A” and “B” in FIG. 10).
- the trigger thread 30 is passed from the back side to the front side of the ring “A” in FIG. 10 and further from the front side to the back side of the ring “B”. This is repeated when there are a plurality of second fixed yarns 22.
- FIG. 11 is a diagram showing an example in which the trigger thread is passed through the second fixed thread.
- the second fixed thread 22 is locked by the trigger thread.
- the trigger thread is pulled out, the second fixed thread 22 is released.
- the first fixed yarn 21 is also released.
- the way of passing the trigger thread 30 through the second fixed thread 22 is not limited to this.
- the trigger yarn 30 may simply pass inside the mountain-folded portion of the second fixed yarn. In this state, when the tube 10 is pulled from the first end side, the folded portion is extended, and the shape of the tube 10 returns to the original shape.
- FIG. 12 is a diagram showing an example of the first knot and the second knot.
- the first fixed yarn 21 and the second fixed yarn 22 are tied at two locations around the first parallel portion of the tube 10 and are fixed to the first parallel portion.
- the place where two places are tied is defined as a first knot and a second knot.
- the first knot exists between the first parallel part and the second parallel part.
- the second knot exists on the opposite side across the first knot and the first parallel portion.
- the first fixing yarn 21 and the second fixing yarn 22 are tied so that the trigger yarn, the fifth parallel portion, the fourth parallel portion, the third parallel portion, and the second parallel portion are not easily detached. It is. There is no particular limitation on how to tie it. In the example of FIG.
- the trigger yarn 30 and the central tube 10 and the central tube 10 are separated from each other, but when the fixed yarn 20 is tied at the position of the first knot, the fixed yarn 20 is pulled.
- the trigger yarn 30 and the tube 10, and the adjacent folded tubes 10 are in close contact with each other.
- the first fixing yarn 21 and the second fixing yarn are tied to the first parallel portion of the tube 10 so that the fixing yarn 20 is fixed.
- the first fixing yarn 21 and the second fixing yarn are tied so that the space inside the tube 10 is not crushed and lost. This allows ventilation between the first end and the second end of the tube 10.
- FIG. 13 is a diagram showing an example of a cross-sectional view of the central portion of the tube in the state of FIG.
- the first fixed yarn is indicated by a solid line
- the second fixed yarn 22 is indicated by a dotted line.
- the first knot exists between the first parallel part and the second parallel part
- the second knot exists on the opposite side across the first knot and the first parallel part.
- the spacer 1 has a configuration as shown in FIGS.
- the number of times the tube 10 is folded and the number of the fixing yarns 20 can be appropriately changed depending on the size of the spacer 1.
- the friction between the trigger yarn 30 and the second fixed yarn 22 is increased, which may make it difficult to pull out the trigger yarn 30.
- the number of trigger yarns 30 can be increased.
- the friction between the trigger yarn 30 and the second fixed yarn 22 may be reduced by changing the way the trigger yarn 30 is passed through the second fixed yarn 22.
- FIG. 14 is a diagram showing an example of a spacer production tool.
- the spacer production tool includes a support base and a plurality of bars. The lengths of the plurality of bars are substantially the same. The plurality of bars are arranged at approximately equal intervals so as to be parallel, and one end of the bars is fixed by a support base.
- the rod and support are fixed.
- the end of the rod may be threaded in the form of a male screw and screwed into a screw hole provided in the support base.
- the end of the rod may be tapered to fit into a hole provided in the support base. You may use the auxiliary member for fixing a stick
- the number of bars is four, but is not limited to four.
- the respective bars are referred to as a first bar, a second bar, a third bar, and a fourth bar from the left side.
- FIG. 15 is a diagram showing a usage example of the spacer production tool of FIG.
- the tube 10 is attached to the spacer production tool.
- the tube 10 passes from the first end side through the back side of the first rod, the front side of the second rod, the back side of the third rod, and the front side of the fourth rod.
- the tube 10 is folded back and passes through the back side of the fourth rod, the front side of the third rod, the back side of the second rod, and the front side of the first rod, and is folded again.
- the tube 10 is attached to the spacer production tool after a total of four turns.
- a dotted line in the bar indicates that the tube 10 passes through the front side of the bar.
- the fixing thread 20 can be easily passed between the tubes 10. After passing the fixing thread, the tube 10 and the fixing thread 20 can be brought into a state as shown in FIG. Further, with the tube 10 fixed to the production tool, the fixing thread is passed, the trigger thread is passed, the first knot is made, the second knot is made, and then the manufactured spacer 1 is removed from the production tool. Good.
- a full-scale design drawing of the spacer to be manufactured can be placed at the back side of the spacer working tool bar.
- the spacer 1 is preferably subjected to aseptic sterilization after production and before implantation in the body.
- the method of aseptic sterilization is not particularly limited.
- the spacer 1 is implanted between a tumor in the body and a normal organ or the like by laparotomy as in FIG.
- a tumor is a target irradiated with a particle beam or the like.
- the particle beam or the like is prevented from being irradiated to the normal organ or the like during the particle beam treatment or the like.
- One end of the tube 10 of the spacer 1 one end of the left end of the tube 10 in FIG. 2 and one end of the trigger thread 30 (one end of the left end of the trigger thread in FIG. 2) are guided outside and fixed.
- the tube 30 is led out of the body through a hole formed in the body surface.
- the method for guiding the tube 30 out of the body is the same as the method for guiding the drain tube out of the body by laparotomy.
- the spacer 1 is manufactured by adjusting the size of the spacer 1 to the size of the position where the spacer 1 is embedded.
- Negative pressure is applied to the tube 10 by connecting a negative pressure pack to one end of the tube 10 guided outside the body, and contaminants (blood, pus, exudate, digestive fluid, etc.) in the abdominal cavity remain in the body. It can be sucked from one end of the tube and guided outside the body. By introducing contaminants in the abdominal cavity outside the body, infection in the abdominal cavity can be controlled. Therefore, the spacer 1 can be embedded in the body even when the intestinal tract is damaged or the intestinal tract is infected.
- the spacer 1 is suitable particularly in the case where a tumor is separated from a digestive tract such as an intestine or stomach that is easily damaged by irradiation.
- the spacer 1 can be used as a spacer in heavy particle beam therapy, radiation therapy, proton therapy, IMRT (Intensity-Modulated Radiation Therapy), and the like.
- the spacer of the present embodiment can be placed even in an operating field with infection, and can be removed without performing a laparotomy after placement.
- the material of the spacer 1 is usually safe because it can be made using a material used in the abdominal cavity in surgery.
- the planar portion of the tube 10 of the spacer 1 forms a space between a normal organ such as the intestinal tract and a tumor, thereby preventing the normal organ such as the intestinal tract from being irradiated with particle beams or the like. it can.
- the infection can be controlled by applying a negative pressure to the tube 10 of the spacer 1 to guide contaminants in the abdominal cavity to the outside of the body. Therefore, the spacer 1 has an infected wound. It can also be used for sites.
- Modification 1 of the spacer 1 will be described.
- the modified example 1 has common points with the spacer 1 described above.
- the difference between the modified example 1 and the spacer 1 will be mainly described, and the description of the common points will be omitted.
- FIG. 16 is a diagram illustrating a configuration example of the spacer according to the first modification.
- the spacer 1 ⁇ / b> A in FIG. 16 includes a tube 10, a first fixing thread 21, a second fixing thread 22, and a trigger thread 30.
- a set of one first fixing thread 21 and one second fixing thread 22 is collectively referred to as a fixing thread 20.
- the spacer 1 ⁇ / b> A in FIG. 16 includes two tubes 10.
- the spacer 1A shown in FIG. 16 is formed by connecting two spacers 1 shown in FIG.
- the shape of each tube of the spacer 1A is the same as that of the spacer 1. That is, each tube 10 includes two end portions and a planar portion formed in a planar shape between the end portions.
- the fixing thread 20 is fixed to each tube 10 by the first knot and the second knot.
- Each tube 10 is maintained in the shape of the planar portion by passing the fixing thread 20 along the outer surface of the tube 10 so as to sew the front side and the back side of the tube 10 alternately.
- the spacer 1 ⁇ / b> A includes two sets of fixing yarns 20 for each tube 10, but the spacer 1 ⁇ / b> A may include two or more sets of fixing yarns 20 for each tube 10. A portion where the fixing thread 20 of one tube 10 is locked to the trigger thread 30 is adjacent to a portion where the fixing thread 20 of the other tube 1 is locked to the trigger thread 30, and the second of the one tube 10 is the second.
- Each tube 10 is arranged so that the knot and the second knot of the other tube are farthest from each other, and a common trigger thread 30 locks the fixing thread 20 of each spacer 1.
- the fixed yarn that maintains the shape of each tube 10 is locked by one trigger yarn 30.
- the method of locking the fixing thread 20 is the same as that of the spacer 1 described above.
- interval of adjacent tubes is vacant, actually, it forms so that adjacent tubes may closely_contact
- the planar portions formed by the two tubes 10 are integrated to form a larger planar portion.
- each tube 10 of the spacer 1A one end of the left end of each tube 10 in FIG. 16
- one end of the trigger thread 30 one end of the left end of the trigger thread 30 in FIG. 16
- the tube 30 is led out of the body through a hole formed in the body surface.
- each fixing thread 20 is passed so as to sew only the outer surface of the tube provided with the knot, but each fixing thread 20 sews the outer surface of the tube other than the tube provided with the knot. May be passed. By doing in this way, two tubes can adhere more stably.
- a larger spacer can be created by using two tubes 10 like the spacer 1A. Moreover, by using the two tubes 10 like the spacer 1A, contaminants in the abdominal cavity can be guided outside the body from two locations in the abdominal cavity. Further, in the spacer 1A, for example, even if one of the tubes 10 cannot be ventilated for some reason, the use of the other tube 10 can guide contaminants in the abdominal cavity to the outside of the body.
- Modification 2 Modification 2 of the spacer 1 will be described.
- the modification 2 has a common point with the spacer 1 described above.
- the difference between the modified example 2 and the spacer 1 will be mainly described, and the description of the common points will be omitted.
- FIG. 17 is a diagram illustrating a configuration example of the spacer according to the second modification.
- 17 includes a tube 10, a first fixing thread 21, a second fixing thread 22, and a trigger thread 30.
- the tube 10 of the spacer 1B in FIG. 17 includes two ends and a spiral portion formed in a spiral shape between the ends.
- the spiral portion of the spacer 1B corresponds to the planar portion of the spacer 1.
- the spacer 1B may be formed in a spiral shape by bending or folding the tube 10.
- the spiral portion of the tube 10 is maintained in a spiral shape by the first fixing yarn 21 and the second fixing yarn 22.
- the spiral portion of the tube 10 is formed so as to surround the periphery of the central tube with a tube on a substantially flat surface.
- the fixing yarn 20 is fixed by the first knot and the second knot around the outermost periphery of the spiral portion of the tube 10.
- the spiral portion of the tube 10 is formed so that the fixing thread 20 sews the front side and the back side of the spiral tube 10 alternately along the outer surface of the tube 10 from the outer peripheral side of the spiral portion toward the center.
- the shape is maintained by being passed.
- the shape of the spiral portion of the tube 10 is maintained by the plurality of fixing threads 20.
- the number of sets of fixed yarns 20 is four, but the number of sets of fixed yarns 20 is not limited to four.
- Each fixing thread 20 is locked by a trigger thread 30.
- the adjacent tubes are spaced apart from each other, but in actuality, the adjacent tubes are formed in close contact with each other.
- One end of the tube 10 of the spacer 1B extends from the center of the spiral part to the outside of the outer periphery of the spiral part.
- the trigger yarn 30 is disposed along the tube 10 that extends from the center of the spiral portion.
- One end of the tube 10 extending outward from the center of the spiral portion (one end of the left end of the tube 10 in FIG. 17) is connected to one end of the trigger yarn 30 (one end of the left end of the trigger yarn 30 in FIG. 17).
- Get out of the body Get out of the body.
- the other end of the tube 10 extends from the outer periphery of the spiral portion toward the tangential direction of the outer periphery.
- the other end of the tube 10 is placed in the body.
- spacer 1B By using the spacer 1B, one end of the tube 10 can be taken out from the vicinity of the center of the spiral portion of the spacer 1B.
- the spacer 1A, or the spacer 1B according to the situation of the body or the like, the degree of freedom of the position of the body where the spacer is installed and the tube is pulled out increases. Said embodiment and each modification can be combined as much as possible.
- Each spacer is an example of an implantable spacer.
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Abstract
Description
本発明は、体内に留置可能で、留置後に容易に摘出可能な体内埋込スペーサーを提供することを目的とする。
即ち、第1の態様は、
一又は複数箇所で折り返されて若しくは折り曲げられて、相互に隣接する部分区間を形成するチューブと、
前記チューブの形状を維持するために、前記部分区間を横断する方向に沿って設けられる固定糸と、
解除可能な状態で前記固定糸を係止するためのトリガー糸とを備える
体内埋込スペーサーとする。
(構成例)
図2は、本実施形態のスペーサーの構成例を示す図である。図2のスペーサー1は、チューブ10、第1固定糸21、第2固定糸22、トリガー糸30を含む。1本の第1固定糸21と1本の第2固定糸22との組を、まとめて、固定糸20ともいう。図2の例では、スペーサー1は、2組の固定糸20を含むが、スペーサー1は、2組以上の固定糸20を含んでもよい。図2の例では、スペーサー1は1本のトリガー糸を含むが、スペーサー1は、複数本のトリガー糸30を含んでもよい。図2において、第1固定糸21または第2固定糸22における点線は、第1固定糸21または第2固定糸22がチューブ10の裏側を通っていることを意味する。
図2のスペーサー1の構成は、図2に示される例に限らず、適宜構成要素の省略、置換、追加が行われてもよい。
図3乃至図13を用いて、スペーサー1の構成について、詳細に説明する。
製作後、体内に埋め込む前に、スペーサー1は、無菌滅菌処理されることが望ましい。無菌滅菌処理の方法は、特に限定されない。
スペーサー1は、開腹手術によって、図1と同様に、体内の腫瘍と正常な器官等との間に埋め込まれる。腫瘍は、粒子線等を照射する対象である。スペーサー1により体内の腫瘍と正常な器官等との間に空間を形成することで、粒子線治療等の際に粒子線等が正常な器官等に照射されないようにする。スペーサー1のチューブ10の一端(図2のチューブ10の左端の一端)及びトリガー糸30の一端(図2のトリガー糸の左端の一端)は、体外に導かれて固定される。チューブ30は、体表面に開けた穴から体外に導かれる。チューブ30を体外に導く方法は、開腹手術でドレーンチューブを体外に導く方法と同様である。スペーサー1の大きさがスペーサー1を埋め込む位置の大きさに合わせられて、スペーサー1は製作される。
本実施形態のスペーサーは、感染を伴う術野でも留置が可能で、留置後に開腹手術を行わなくても摘出可能である。スペーサー1の材料は、通常、手術において腹腔内で使用されている素材を用いて作成可能であるため、安全である。
ここで、上記のスペーサー1の変形例1を説明する。変形例1は、上記のスペーサー1と共通点を有する。ここでは、主に、変形例1とスペーサー1との相違点ついて説明し、共通点については説明を省略する。
ここで、上記のスペーサー1の変形例2を説明する。変形例2は、上記のスペーサー1と共通点を有する。ここでは、主に、変形例2とスペーサー1との相違点ついて説明し、共通点については説明を省略する。
上記の実施形態、各変形例は、可能な限り組み合わせられ得る。各スペーサーは、体内埋込スペーサーの一例である。
10 チューブ
20 固定糸
21 第1固定糸
22 第2固定糸
30 トリガー糸
1A スペーサー
1B スペーサー
Claims (8)
- 一又は複数箇所で折り返されて若しくは折り曲げられて、相互に隣接する部分区間を形成するチューブと、
前記チューブの形状を維持するために、前記部分区間を横断する方向に沿って設けられる固定糸と、
解除可能な状態で前記固定糸を係止するためのトリガー糸とを備える
体内埋込スペーサー。 - 前記固定糸は、第1固定糸と第2固定糸とを含み、前記各部分区間において第1固定糸と第2固定糸とが互いにチューブの反対側の外面に接するように設けられる請求項1に記載の体内埋込スペーサー。
- 第1固定糸と第2固定糸とは、それぞれ、前記複数の隣接する部分区間について、前記構造体の一方の面に対する表側と背面側とに交互に設けられる請求項2に記載の体内埋込スペーサー。
- 前記チューブは、両端間で通気可能に、折り返される
請求項1から3のいずれか1項に記載の体内埋込スペーサー。 - 前記固定糸によって形状を維持される前記チューブを2組含み、前記チューブの形状を維持する各前記固定糸はそれぞれ前記トリガー糸によって係止される
請求項1から4のいずれか1項に記載の体内埋込スペーサー。 - 前記チューブの形状は、渦巻状に形成される
請求項1から4のいずれか1項に記載の体内埋込スペーサー。 - 一又は複数箇所で折り返されて若しくは折り曲げられて、相互に隣接する部分区間を形成するチューブと、前記チューブの形状を維持するために、前記部分区間を横断する方向に沿って設けられる固定糸と、解除可能な状態で前記固定糸を係止するためのトリガー糸とを備える体内埋込スペーサーを、前記チューブの一端と前記トリガー糸の一端とを体外に導いて体内に埋め込み、
前記トリガー糸の前記一端を引いて前記トリガー糸を体外に取り出すことで、前記固定糸を解除し、
前記チューブの前記一端を引いて前記チューブ及び前記固定糸を体外に取り出すことを含む、
体内埋込スペーサー取り出し方法。 - 一又は複数箇所で折り返されて若しくは折り曲げられて、相互に隣接する部分区間を形成するチューブと、前記チューブの形状を維持するために、前記部分区間を横断する方向に沿って設けられる固定糸と、解除可能な状態で前記固定糸を係止するためのトリガー糸とを備え、前記チューブが両端間で通気可能に折り返される体内埋込スペーサーを、前記チューブの一端と前記トリガー糸の一端とを体外に導いて体内に埋め込み、
前記チューブの前記一端に陰圧をかけて、前記チューブの他端から前記体内の汚染物を体外に吸引することを含む、
体内埋込スペーサーによる汚染物吸引方法。
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