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WO2015059733A1 - Prosthesis for repairing hernia - Google Patents

Prosthesis for repairing hernia Download PDF

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Publication number
WO2015059733A1
WO2015059733A1 PCT/JP2013/006218 JP2013006218W WO2015059733A1 WO 2015059733 A1 WO2015059733 A1 WO 2015059733A1 JP 2013006218 W JP2013006218 W JP 2013006218W WO 2015059733 A1 WO2015059733 A1 WO 2015059733A1
Authority
WO
WIPO (PCT)
Prior art keywords
hernia
prosthesis
sac
mesh
abdominal cavity
Prior art date
Application number
PCT/JP2013/006218
Other languages
French (fr)
Japanese (ja)
Inventor
裕夫 嵩原
Original Assignee
株式会社ニチオン
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 株式会社ニチオン filed Critical 株式会社ニチオン
Priority to PCT/JP2013/006218 priority Critical patent/WO2015059733A1/en
Publication of WO2015059733A1 publication Critical patent/WO2015059733A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063Implantable repair or support meshes, e.g. hernia meshes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646Type of implements
    • A61B2017/00659Type of implements located only on one side of the opening
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646Type of implements
    • A61B2017/00663Type of implements the implement being a suture
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0067Three-dimensional shapes conical

Definitions

  • the present invention relates to a prosthesis for repairing a hernia, and particularly to a prosthesis suitably used for repairing an inguinal hernia.
  • a gap portion can be congenital or acquired in an abdominal wall forming an abdominal cavity in a living body. If the gap exists, organs in the abdominal cavity may protrude from the normal position to the body surface side through the gap (hernia gate) due to, for example, an increase in abdominal pressure, and hernia may develop. .
  • the gap IO exists near the groin, so that the organ IO in the abdominal cavity AC passes through the gap G as shown in FIG.
  • An abdominal hernia such as an outer inguinal hernia, an inner inguinal hernia or a femoral hernia may develop by protruding to the BS side.
  • a gap G is formed by the patency of peritoneal sheath-like projections that are normally closed with growth, or by the expansion of the inner inguinal ring of the inguinal heel due to fascia or abdominal muscle weakening. May develop hernia.
  • the gap G may be formed due to the weakening of the transverse muscle fascia of the inguinal heel and the thigh ring, which is a passage of blood vessels to the leg, and an internal inguinal hernia or femoral hernia may occur.
  • an inguinal portion is incised and approached to the gap from the operator side, and a hernia is repaired, and a gap is placed under the laparoscope without incising the inguinal portion.
  • Approaches and methods of repairing hernias are known.
  • the method of repairing hernia by incising the groin is generally used for treating adult abdominal hernia regardless of the type of hernia.
  • the hernia sac PP the portion of the peritoneum P protruding from the hernia gate
  • the hernia gate G (gap portion) is excised, and then the hernia gate G Reinforcement is performed.
  • a method of repairing hernia by incising the inguinal region for example, a method of bringing the fascia and muscle around the hernia gate G together and suturing (direct suture method), or indwelling in the human body
  • a method (mesh method) in which an artificial object (prosthesis) made of mesh is placed in the hernia gate is adopted, and the hernia gate G is reinforced by sewing or prosthesis.
  • the biocompatible mesh 1 made of polypropylene or the like as a prosthesis is fixed to the fascia around the hernia gate G with a suture thread, whereby the mesh 1
  • reinforcement of the hernia gate G is achieved by growing a cell tissue so as to be integrated with the mesh 1 to form a scar tissue. Therefore, according to the mesh method, the hernia recurrence rate can be improved as compared with the direct suture method.
  • the mesh 1 used in the mesh method is a sheet-like mesh 1a for covering the hernia gate G by being arranged on the outer side (body surface BS side) and / or the inner side (abdominal cavity AC side) of the hernia gate G.
  • a mesh plug 1b that is inserted into the hernia gate G and fixed to the preperitoneal space between the peritoneum P and the fascia around the hernia gate G is used.
  • the mesh plug 1b is equipped with the some mesh for maintaining the plug shape and increasing the bulk of the mesh plug itself in the inside (for example, refer patent document 1).
  • the mesh method when the mesh 1 is placed and fixed, the cellular tissue around the hernia G is incised extensively including the healthy part, and the cellular tissue is peeled off to surround the hernia G. Preventively reinforce a wider area than the lesion. Therefore, in the mesh method, when the mesh 1, particularly the mesh plug 1b as described in Patent Document 1, is moved in the surrounding tissue, or scar tissue is formed in the mesh 1 in an unfavorable manner, There is a possibility that the organ IO in the abdominal cavity AC is injured when 1 and the surrounding tissue adhere to each other in an undesirable manner. And when organ IO is injured, there exists a possibility that a complication may develop. Therefore, the mesh method has a problem that the hernia recurrence rate can be reduced, but it is necessary to reduce the influence on the living body in which the prosthesis is placed.
  • a laparoscope is inserted into the abdominal cavity AC of the patient's abdomen AR without incising the patient's body surface BS, and the hernia sac PP is ligated with sutures at the hernia gate G as shown in FIG.
  • a method of ligation and closing (laparoscopic percutaneous extraperitoneal closure, hereinafter referred to as “LPEC method”) has attracted attention.
  • the hernia repair method using a laparoscope differs from the direct suture method or mesh method in which a large incision is made from the body surface BS side to the structure of the inguinal canal where the external inguinal hernia develops. Since the hernia sac PP can be ligated with a suture without destroying the structure of the hernia sac, the structure of the inguinal fold around the hernia gate G is considered to be lovable.
  • the LPEC method using a laparoscope when the LPEC method using a laparoscope is applied to an abdominal hernia that has developed especially in an adult, the hernia portal G of the adult is large and the tissues such as fascia around the hernia G are hardened and weakened. Therefore, there is a risk that the hernia will recur if the hernia sac PP is simply tied by high ligation. Therefore, although the LPEC method can suppress the influence on a living body caused by a wide range of incisions and indwelling prostheses, it is difficult to permanently close the hernia sac PP when applied to an adult, for example. was there.
  • the present inventor does not need a wide incision, and in order to establish a technique that can sufficiently prevent hernia recurrence in the LPEC method that can reduce the influence on the living body caused by the indwelling prosthesis.
  • the inventor of the present invention has come up with the idea of reinforcing hernia sac closure in the LPEC method so that recurrence of the hernia can be sufficiently prevented even when applied to an adult, for example. Therefore, the present inventor has further studied, and in the LPEC method, the distal end side of the hernia sac (the side opposite to the abdominal cavity side) becomes a closed space rather than the position where the hernia sac is ligated at a high position.
  • the present inventor has further researched and found the shape of a prosthesis suitable for fixing to the distal end side of the hernia sac in the vicinity of the hernia gate and the position where high ligation is performed, and completed the present invention.
  • the hernia repair prosthesis of the present invention is characterized by comprising a mesh sheet formed in a hollow cone shape.
  • the prosthesis formed of a mesh-like sheet and formed in the shape of a hollow cone is composed of a peritoneum portion (hereinafter also referred to as “projection peritoneum portion”) protruding to the body surface side through the hernia gate. Easy to insert and fix under the laparoscope on the distal side of the hernia sac.
  • the hernia repair prosthesis of the present invention is preferably composed of a single-layer mesh sheet.
  • the prosthesis is easily crushed inside the hernia sac, and the closure of the hernia sac can be effectively reinforced.
  • the hernia repair prosthesis according to the present invention has a maximum width measured along the direction orthogonal to the axial direction of 10 to 30 mm and a length measured along the axial direction of 15 to 40 mm. Is preferred.
  • the mesh sheet preferably has a wire diameter of 0.15 to 0.35 mm.
  • the hernia repair prosthesis of the present invention preferably has a fixing mark.
  • the fixing mark is provided, the prosthesis can be fixed to the inside of the hernia sac reliably and easily.
  • the hernia repair prosthesis of the present invention can be used by being inserted into the hernia sac from the abdominal side.
  • the prosthesis for repairing a hernia of the present invention it is possible to provide a technique that can sufficiently prevent the recurrence of the hernia in the LPEC method that can reduce the influence on the living body.
  • FIG. 5 shows a cross-sectional view along the line aa in FIG. It is a perspective view which shows the prosthesis for the hernia repair of this invention.
  • the hernia repair prosthesis of the present invention is for preventing an organ in the abdominal cavity from deviating from the gap between the abdominal walls forming the abdominal cavity.
  • the hernia repair prosthesis of the present invention is for repairing a so-called hernia in which an organ in the abdominal cavity protrudes from the normal position to the surface of the body due to the presence of a gap in the abdominal wall. Can be used.
  • the hernia to be repaired is not limited, but, for example, abdominal hernias such as external inguinal hernias, internal inguinal hernias, and femoral hernias that develop near the inguinal region that is the base of the thigh of the human body. Is mentioned.
  • the hernia repair prosthesis of the present invention is characterized by comprising a mesh sheet formed in a hollow cone shape, and a protruding peritoneal portion (hernia) which is a part of the peritoneum protruding to the body surface side through a gap. It is fixed inside the sac.
  • hernia repair method using the hernia repair prosthesis of the present invention will be described with reference to FIG. Specifically, referring to FIG. 4, a hernia in which an organ IO in the abdominal cavity AC protrudes from the gap G of the abdominal wall AW forming the abdominal cavity AC to the body surface BS side is treated as a hernia repair prosthesis of the present invention.
  • the following hernia repairing methods can be used particularly suitably for mild or moderate hernias with a hernia gate composed of the gap G having a diameter of less than 30 mm.
  • the operation means for example, grasping forceps
  • the operation hole for inserting into the abdominal cavity AC is formed with an operation hole for inserting into the abdominal cavity AC.
  • the umbilicus of the abdominal part AR is incised into a size of about 3 to 10 mm, preferably about 3 to 5 mm, using a scalpel blade, and the incised place is punctured using a puncture device, for example. Can be formed.
  • the laparoscopic hole includes a needle that can be punctured into the abdominal cavity AC, and an outer tube that can be inserted into the laparoscope and that has a length that allows the tip of the needle to protrude in a combined state.
  • a device eg, trocar
  • the needle is removed from the outer tube (trocar sleeve) and placed with the outer tube (trocar sleeve) penetrating the abdomen AR.
  • the operation hole is formed as a laparoscopic hole, and then gas is injected from the laparoscopic hole so that the abdominal cavity pressure in the abdominal cavity AC is, for example, about 1 kPa. It can be formed by puncturing the abdomen AR using a simple puncture device.
  • the prosthesis 2 which is the prosthesis for repairing the hernia of the present invention is introduced into the abdominal cavity AC through the laparoscopic hole or the operation hole, and the prosthesis 2 from the abdominal cavity AC inside the hernia sac PP by the operation means. Deploy.
  • the inner diameter of the gap G can be measured in advance.
  • a measuring means for example, a suture having a predetermined length is placed inside the gap G, and the size of the measuring means is compared with the size of the gap G while observing with a laparoscope.
  • the inner diameter of the part G can be measured.
  • the fixation of the prosthesis 2 to the hernia sac PP and the diameter reduction of the hernia sac PP can be performed by fixing the prosthesis 2 to the hernia sac PP with the suture 3 and strongly binding the suture 3.
  • the diameter of the hernia sac PP can be reduced with a suture thread 3 different from the suture thread.
  • the prosthesis 2 can be sutured to the hernia sac PP using any means, but a needle that can be punctured while grasping the suture while observing from the abdominal cavity AC with a laparoscope. Can be performed by using a suture needle such as a suture passer and an operating means located in the abdominal cavity AC. Specifically, the tip of the suturing needle is introduced from the body surface BS side while holding the suture thread 3, pierced through the hernia sac PP, and sutured to the operating means (for example, grasping forceps) through the prosthesis 2.
  • the operating means for example, grasping forceps
  • the suture needle from which the suture thread 3 has been released is pulled out of the hernia sac PP and moved by moving the outer periphery of the hernia sac PP in the circumferential direction. Thereafter, the suture needle thus moved is used to puncture the hernia sac PP at a position different from the previous position, and the suture thread 3 is transferred from the operating means to the suture needle.
  • the hernia sac PP and the prosthesis 2 are sutured over the outer periphery thereof, and then the tip of the suture 3 is placed on the body surface BS side.
  • the prosthesis 2 can be fixed to the hernia sac PP by taking out and combining the front end side and the rear end side of the suture thread 3. Further, when the distal end side and the rear end side of the suture thread 3 are tied together, the hernia sac PP can be reduced in diameter together with the prosthesis 2 by tightly binding the suture thread 3. At this stage, the hernia sac PP may be slightly opened without being blocked after the hernia sac PP is reduced in diameter. Moreover, how the suture thread 3 passes through the hernia sac PP and the prosthesis 2 is not limited to the method of FIG. 5 and can be arbitrarily changed. Furthermore, the suture for fixing the prosthesis 2 and reducing the diameter of the hernia sac PP can be performed a plurality of times.
  • the hernia sac PP is sutured and ligated at a position inside the abdominal cavity AC from the fixed position of the prosthesis 2 (see FIG. 5C).
  • the ligation of the hernia sac PP can be performed using a known method used in the conventional LPEC method, for example, using a suture needle and operation means while observing from the abdominal cavity AC with a laparoscope Can be done. Specifically, the distal end of the suture needle is introduced from the body surface BS side with the suture thread 4 held, and the outer circumference of the hernia sac PP on the abdominal cavity AC side of the prosthesis 2 is moved to one side in the circumferential direction.
  • the hernia sac PP is pierced and the suture 4 is passed to the operating means (for example, grasping forceps). Then, the tip of the suture needle from which the suture thread 4 has been released is pulled back out of the hernia sac PP, and the outer periphery of the hernia sac PP is moved to the other side in the circumferential direction.
  • the suture thread 4 is passed through the operating means to the suturing needle. After passing the suture thread 4 over the outer periphery of the hernia sac PP, the distal end of the suture thread 4 is put out on the body surface BS side, and the distal end side and the rear end side of the suture thread 4 are tied together and tied tightly.
  • the suturing for ligation of the hernia sac PP can be performed a plurality of times.
  • the ligation position of the hernia sac PP is preferably an opening on the abdominal cavity AC side of the gap G.
  • the prosthesis 2 is fixed to the hernia sac PP more than the position where the hernia sac PP is ligated and closed. The position is preferably 5 to 10 mm moved to the opposite side).
  • the laparoscope and the operation means are extracted from the abdominal cavity AC, and the laparoscope hole and the operation hole are closed.
  • observation with a laparoscope is performed, and if another hernia sac PP exists in the abdominal cavity AC, the hernia sac PP can be ligated and closed. .
  • the hernia sac PP is used without greatly incising the body surface BS by using the suture needle introduced from the body surface BS side and the operation means inserted into the abdominal cavity AC while using the laparoscope. Since the hernia is repaired without damaging the cellular tissue structure around the gap G, the organ IO in the abdominal cavity AC is prevented from deviating from the gap G. Can do. That is, the hernia can be repaired without destroying the cell tissue structure as compared with the direct suture method or the conventional mesh method. Therefore, there is little physical burden on the patient, and early recovery and discharge can be realized.
  • the hernia sac PP when the hernia sac PP is ligated and closed with a suture, the prosthesis 2 is fixed to the hernia sac PP, and the prosthesis 2 is fixed and the inner peripheral surface of the hernia sac PP is fixed. Because of the close contact, scar tissue can be formed so as to be integrated with the prosthesis 2 in the hernia sac PP. Therefore, since the scar tissue effectively adheres to the inner peripheral surface of the hernia sac PP, the closure of the hernia sac PP is reinforced compared to the case where the prosthesis 2 is not used (that is, the conventional general LPEC method). can do.
  • the scar tissue is smaller than the conventional mesh method and the scar tissue is formed in a closed space of the hernia sac PP, an abdominal cavity AC using a mesh plug or the like that may occur when the conventional mesh method is adopted.
  • the possibility of damage to the internal organ IO can be reduced. Therefore, according to this repair method, the organ IO in the abdominal cavity AC is sufficiently prevented from deviating again from the gap G of the abdominal wall AW forming the abdominal cavity AC while reducing the influence on the living body due to the placement of the prosthesis 2. can do.
  • This repair method can be applied regardless of the size of the gap G. From the viewpoint of effectively preventing the organ IO in the abdominal cavity AC from deviating, the gap having a diameter of less than 30 mm is used. It is preferable to apply when G.
  • the hernia repair prosthesis of the present invention described later can be suitably used as the prosthesis 2.
  • the above repair method can be used regardless of the age of the patient, and can be applied not only to the human body but also to animals.
  • the prosthesis 5 which is an example of the hernia repair prosthesis of the present invention is configured by a mesh-like sheet having biocompatibility.
  • the prosthesis 5 has a cone shape having a cavity 7 inside the prosthesis 5 (that is, a hollow cone shape), in other words, one end 8 side in the axial direction (in FIG. 6).
  • the cross-sectional area orthogonal to the axial direction is larger than the cross-sectional area on the other axial end 9 side (left side in FIG. 6).
  • the prosthesis 5 is comprised by the mesh-like sheet
  • the prosthesis 5 is formed by bending a single mesh sheet into a conical shape, and using a biocompatible thread (for example, a suture thread) to bind and overlap the overlapping portions of the mesh sheet. By doing so or by heat-sealing the overlapped portion, it is formed in a hollow cone shape.
  • a biocompatible thread for example, a suture thread
  • a biocompatible material for example, a mesh sheet made of polyethylene, polypropylene or a mixture thereof, or a mesh formed by coating a mesh member made of such resin with, for example, titanium or the like.
  • a sheet can be used.
  • the prosthesis 5 is provided with a fixing mark M for facilitating the fixation of the prosthesis 5 to the hernia sac PP.
  • a fixing mark M for facilitating the fixation of the prosthesis 5 to the hernia sac PP.
  • one or more (four in the illustrated example) marks M are provided around one end side portion on the axial one end 8 side of the prosthesis 5.
  • a mark M extending from the apex of the cone toward the outer peripheral edge of the bottom surface is also provided.
  • the mark M both one or more marks around the one end side portion and a mark extending from the apex of the cone toward the outer peripheral edge of the bottom surface are provided.
  • the mark M may be formed by coloring the mesh sheet, or a thread having a color different from that of the mesh sheet and having biocompatibility (for example, a suture thread). You may form by tying and fixing to a mesh-like sheet. As described above, when forming a hollow cone-shaped prosthesis by bending the mesh sheet and fixing with a biocompatible thread, the thread used for fixing the mesh sheet is mesh-shaped. By using a thread having a color different from that of the sheet, the fixing thread can also function as the mark M. Thus, if the fixing thread functions as the mark M, the mark M can be provided at a low cost using a simple configuration.
  • the prosthesis 5 has a hollow cone shape
  • the prosthesis 5 when used in the above-described novel hernia repair method, the prosthesis 5 is moved from the inner side of the abdominal cavity AC to the inner side of the hernia sac PP even in a narrow space in the abdominal cavity AC. Can be easily inserted and arranged.
  • the hollow cone-shaped prosthesis 5 can be moved while being held from the inner peripheral surface side using an operation means such as a grasping forceps, and the hernia gate can be moved from the other axial end 9 side having a small cross-sectional area. And can be easily inserted into the hernia sac PP.
  • the prosthesis 5 since the prosthesis 5 is formed of a mesh sheet, the prosthesis 5 can be easily sutured to the hernia sac PP. Further, since the prosthesis 5 is hollow, it can be easily inserted into the abdominal cavity AC through a laparoscopic hole or an operation hole in a small folded state. Furthermore, the hollow prosthesis 5 does not generate excessive reaction force due to deformation of the prosthesis 5 when the hernia sac PP is reduced in diameter together with the prosthesis as shown in FIGS. 4 (a) to 4 (b).
  • the hernia sac PP and the prosthesis 5 can be brought into close contact with the prosthesis 5 in a state of matching the shape of the inner peripheral surface of the hernia sac PP. Furthermore, since the prosthesis 5 is a biocompatible mesh sheet, cells can form scar tissue densely with respect to the prosthesis 5 using the mesh structure as a scaffold. Therefore, the inner peripheral surface of the hernia sac PP can be effectively adhered.
  • the prosthesis 5 has a shape that does not have a cavity 7 inside, for example, a mesh plug shape as described in Patent Document 1 described above (a plurality of meshes that reinforce the plug shape and increase the bulk of the mesh plug itself. If it is made a solid structure), it cannot be folded small, and it becomes difficult to insert it into the abdominal cavity AC from the laparoscopic hole or the operation hole. In addition, when the prosthesis 5 has a solid structure, it becomes difficult to suture the prosthesis 5 to the hernia sac PP, and when the hernia sac PP is reduced in diameter, an excessive reaction force is generated due to the presence of an internal mesh. It becomes difficult to close the inner peripheral surface of the sac PP.
  • the wire diameter of the mesh sheet is preferably 0.15 to 0.35 mm.
  • the wire diameter of the mesh sheet is set to 0.35 mm or less, the bending rigidity of the mesh sheet is reduced, the folding is facilitated, and the adhesion to the inner peripheral surface of the hernia sac PP is increased.
  • the wire diameter of the mesh sheet is 0.15 mm or more, the strength can be ensured.
  • the opening diameter of the mesh sheet is preferably 1.0 mm to 2.0 mm.
  • the opening diameter of the mesh sheet When the opening diameter of the mesh sheet is set to 1.0 mm or more, the bending rigidity of the mesh sheet is reduced, the folding becomes easy, and the adhesion to the inner peripheral surface of the hernia sac PP is increased. In addition, if the opening diameter of the mesh sheet is 2.0 mm or less, the strength can be ensured.
  • the prosthesis 5 described above has the mark M, when the prosthesis 5 is sutured and fixed to the hernia sac PP, the position to be sutured can be easily confirmed using a laparoscope. .
  • the prosthesis 5 is hollow, and when it is placed in the hernia sac PP, the prosthesis 5 is crushed and the inner peripheral surfaces of the prosthesis 5 are in contact with each other. If provided, the prosthesis 5 can be fixed to the hernia sac PP at an appropriate position.
  • the prosthesis 5 may be provided with a reinforcing member that holds the shape of the prosthesis 5 until it is installed in the hernia sac PP. If the reinforcing member is provided, for example, even when the prosthesis 5 is folded into the abdominal cavity AC, the collapsed state can be quickly eliminated after the prosthesis 5 is introduced into the abdominal cavity AC. Therefore, when the prosthesis 5 is installed in the hernia sac PP, it is possible to prevent an appropriate suture position from becoming difficult to grasp due to contact between the inner peripheral surfaces of the prosthesis 5 or the like.
  • the reinforcing member is not limited as long as it has biocompatibility and does not exhibit a large reaction force that prevents the diameter reduction of the hernia sac PP. For example, a ring-shaped member Can be used.
  • the prosthesis 5 is preferably sized according to the diameter. Therefore, it is preferable that the prosthesis 5 has a maximum width W measured along the direction orthogonal to the axial direction of 10 to 30 mm, and a length D measured along the axial direction of 15 to 40 mm. In the illustrated example, one end 8 in the axial direction has a maximum width W.
  • the prosthesis can have any shape as long as it has a hollow cone shape with a cavity inside.
  • the shape of the prosthesis may be a cone (cone shape) as shown in FIG. 6, a polygonal pyramid such as a triangular pyramid, a quadrangular pyramid, or an elliptical pyramid.
  • the shape of the prosthesis may be a truncated cone.
  • the prosthesis 5 shown in FIG. 6 is open only at one axial end 8 side, the prosthesis may be open at the other axial end.
  • the prosthesis may be composed of a multilayer mesh sheet.
  • the prosthesis is 1 It is preferable to comprise a layered mesh sheet.
  • the prosthesis may be formed into a cone shape by integral molding, but from the viewpoint of cost and compatibility with a living body, one mesh sheet is bent into a conical shape, and a suture thread or the like is used. It is preferable to form a cone by fixing them.
  • the prosthesis for repairing a hernia of the present invention it is possible to provide a technique that can sufficiently prevent the recurrence of the hernia in the LPEC method that can reduce the influence on the living body.

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  • Veterinary Medicine (AREA)
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  • Prostheses (AREA)

Abstract

The present invention addresses the problem of providing a technique for sufficiently preventing relapse of hernia in the LPEC method wherein no wide-range incision is needed and effects of a placed prosthesis on a living body can be minimized. A prosthesis for repairing hernia characterized by comprising a mesh-type sheet that is formed into a hollow conical shape.

Description

ヘルニア修復用プロテーゼHernia repair prosthesis
 本発明は、ヘルニア修復用プロテーゼに関し、特には、鼠径ヘルニアの修復に好適に用いられるプロテーゼに関するものである。 The present invention relates to a prosthesis for repairing a hernia, and particularly to a prosthesis suitably used for repairing an inguinal hernia.
 従来、生体内で腹腔を形成する腹壁には、間隙部が、先天的にあるいは後天的に発生し得ることが知られている。そして、その間隙部が存在すると、腹腔内の臓器などが、通常あるべき位置から例えば腹圧の上昇などによって間隙部(ヘルニア門)を介して体表面側に突出し、ヘルニアを発症することがある。例えば、人体の太ももの付け根部分である鼠径部付近では、当該鼠径部付近に間隙部が存在することによって、図1に示すように、腹腔AC内の臓器IOが間隙部Gを介して体表面BS側に突出して、外鼠径ヘルニア、内鼠径ヘルニアまたは大腿ヘルニアなどの腹部ヘルニアが発症することがある。具体的には、成長に伴い通常は閉鎖される腹膜鞘状突起の開存により、或いは、筋膜や腹筋の衰えによる鼠径菅の内鼠径輪の広がりにより、間隙部Gが形成されて外鼠径ヘルニアを発症することがある。また、鼠径菅の横筋筋膜や脚への血管の通り道である大腿輪の脆弱化により、間隙部Gが形成されて内鼠径ヘルニアや大腿ヘルニアを発症することがある。 Conventionally, it is known that a gap portion can be congenital or acquired in an abdominal wall forming an abdominal cavity in a living body. If the gap exists, organs in the abdominal cavity may protrude from the normal position to the body surface side through the gap (hernia gate) due to, for example, an increase in abdominal pressure, and hernia may develop. . For example, in the vicinity of the groin, which is the base of the thigh of the human body, the gap IO exists near the groin, so that the organ IO in the abdominal cavity AC passes through the gap G as shown in FIG. An abdominal hernia such as an outer inguinal hernia, an inner inguinal hernia or a femoral hernia may develop by protruding to the BS side. Specifically, a gap G is formed by the patency of peritoneal sheath-like projections that are normally closed with growth, or by the expansion of the inner inguinal ring of the inguinal heel due to fascia or abdominal muscle weakening. May develop hernia. In addition, the gap G may be formed due to the weakening of the transverse muscle fascia of the inguinal heel and the thigh ring, which is a passage of blood vessels to the leg, and an internal inguinal hernia or femoral hernia may occur.
 ここで、腹部ヘルニアを治療する方法としては、鼠径部を切開して術者側から間隙部にアプローチし、ヘルニアを修復する方法と、鼠径部を切開することなく、腹腔鏡下で間隙部にアプローチし、ヘルニアを修復する方法とが知られている。 Here, as a method of treating an abdominal hernia, an inguinal portion is incised and approached to the gap from the operator side, and a hernia is repaired, and a gap is placed under the laparoscope without incising the inguinal portion. Approaches and methods of repairing hernias are known.
 これらの中でも、鼠径部を切開してヘルニアを修復する方法は、一般に、上記のヘルニアの種類にかかわらず、成人の腹部ヘルニアの治療に多く用いられている。そして、鼠径部を切開してヘルニアを修復する方法では、ヘルニア門G(間隙部)から突出したヘルニア嚢PP(腹膜Pのうち、ヘルニア門から突出した部分)を切除した後、ヘルニア門Gの補強が実施される。
 具体的には、鼠径部を切開してヘルニアを修復する方法としては、例えば、ヘルニア門Gの周囲の筋膜や筋肉を寄せて縫合する方法(直接縫合法)や、人体内に留置可能なメッシュよりなる人工物(プロテーゼ)をヘルニア門に留置する方法(メッシュ法)が採用され、縫合やプロテーゼによるヘルニア門Gの補強が実施されている。
Among these, the method of repairing hernia by incising the groin is generally used for treating adult abdominal hernia regardless of the type of hernia. In the method of repairing the hernia by incising the inguinal portion, the hernia sac PP (the portion of the peritoneum P protruding from the hernia gate) protruding from the hernia gate G (gap portion) is excised, and then the hernia gate G Reinforcement is performed.
Specifically, as a method of repairing hernia by incising the inguinal region, for example, a method of bringing the fascia and muscle around the hernia gate G together and suturing (direct suture method), or indwelling in the human body A method (mesh method) in which an artificial object (prosthesis) made of mesh is placed in the hernia gate is adopted, and the hernia gate G is reinforced by sewing or prosthesis.
 しかし、直接縫合法には、縫合によりヘルニア門の周囲の筋肉を寄せるので患部にツッパリ感を感じるという問題、および、ヘルニア門周辺の筋肉の更なる脆弱化などによりヘルニアが再発する虞があるという問題がある。 However, in the direct suturing method, the muscles around the hernia gate are brought together by suturing, so there is a problem that the affected area feels a crispness, and the hernia may recur due to further weakening of the muscle around the hernia gate. There's a problem.
 一方、メッシュ法では、図2に示すように、プロテーゼとしての、ポリプロピレンなどからなる生体適合性のメッシュ1を、ヘルニア門Gの周囲の筋膜等に縫合糸で固定することによって、メッシュ1の構造内に、メッシュ1と一体化するように細胞組織を成長させて瘢痕組織を形成させることで、ヘルニア門Gの補強を達成する。従って、メッシュ法によれば、上記の直接縫合法よりもヘルニア再発率を改善することができる。
 なお、メッシュ法で使用されるメッシュ1としては、ヘルニア門Gのよりも外側(体表面BS側)および/または内側(腹腔AC側)に配置してヘルニア門Gを覆うためのシート状メッシュ1aや、ヘルニア門Gに差し込んで、腹膜Pとヘルニア門Gの周囲の筋膜との間の腹膜前腔に固定する、メッシュプラグ1bが用いられる。そして、メッシュプラグ1bは、その内部に、プラグ形状を維持し且つメッシュプラグ自体の嵩を増すための複数のメッシュを備えている(例えば、特許文献1参照)。
On the other hand, in the mesh method, as shown in FIG. 2, the biocompatible mesh 1 made of polypropylene or the like as a prosthesis is fixed to the fascia around the hernia gate G with a suture thread, whereby the mesh 1 In the structure, reinforcement of the hernia gate G is achieved by growing a cell tissue so as to be integrated with the mesh 1 to form a scar tissue. Therefore, according to the mesh method, the hernia recurrence rate can be improved as compared with the direct suture method.
Note that the mesh 1 used in the mesh method is a sheet-like mesh 1a for covering the hernia gate G by being arranged on the outer side (body surface BS side) and / or the inner side (abdominal cavity AC side) of the hernia gate G. Alternatively, a mesh plug 1b that is inserted into the hernia gate G and fixed to the preperitoneal space between the peritoneum P and the fascia around the hernia gate G is used. And the mesh plug 1b is equipped with the some mesh for maintaining the plug shape and increasing the bulk of the mesh plug itself in the inside (for example, refer patent document 1).
 しかし、メッシュ法では、メッシュ1を配置して固定する際、ヘルニア門Gの周囲の細胞組織を健全な部分も含めて広範囲に切開し、細胞組織の間を剥離して、ヘルニア門Gの周囲の病変部よりも広い範囲を予防的に補強する。したがって、メッシュ法では、メッシュ1、特に、特許文献1に記載のようなメッシュプラグ1bが、周囲の組織内で移動した場合、または、好ましくない態様でメッシュ1に瘢痕組織が形成されたり、メッシュ1とその周囲の組織とが好ましくない態様で癒着したりした場合に、腹腔AC内の臓器IOを傷つける可能性が有る。そして、臓器IOが傷つけられた場合、合併症が発症する虞がある。よって、メッシュ法には、ヘルニア再発率が低減可能であるが、プロテーゼを留置した生体への影響を低減する必要があるという問題があった。 However, in the mesh method, when the mesh 1 is placed and fixed, the cellular tissue around the hernia G is incised extensively including the healthy part, and the cellular tissue is peeled off to surround the hernia G. Preventively reinforce a wider area than the lesion. Therefore, in the mesh method, when the mesh 1, particularly the mesh plug 1b as described in Patent Document 1, is moved in the surrounding tissue, or scar tissue is formed in the mesh 1 in an unfavorable manner, There is a possibility that the organ IO in the abdominal cavity AC is injured when 1 and the surrounding tissue adhere to each other in an undesirable manner. And when organ IO is injured, there exists a possibility that a complication may develop. Therefore, the mesh method has a problem that the hernia recurrence rate can be reduced, but it is necessary to reduce the influence on the living body in which the prosthesis is placed.
 このような問題に対し、近年、鼠径部やヘルニア門Gの周囲の細胞組織を切開することなくヘルニアを修復可能な方法として、腹腔鏡下で間隙部にアプローチしてヘルニアを修復する方法が注目されている。具体的には、患者の体表面BSを切開せずに患者の腹部ARの腹腔AC内に腹腔鏡を挿入し、図3に示すようにヘルニア門Gにおいてヘルニア嚢PPを縫合糸で結紮(高位結紮)して閉鎖する方法(腹腔鏡下経皮的腹膜外ヘルニア閉鎖術(Laparoscopic percutaneous extraperitoneal closure)、以下「LPEC法」と称する。)が注目されている。そして、LPEC法のように腹腔鏡を用いたヘルニア修復法は、体表面BS側から例えば外鼠径ヘルニアが発症する鼠径管の構造までを大きく切開する直接縫合法やメッシュ法とは異なり、鼠径管の構造を破壊することなくヘルニア嚢PPを縫合糸で高位結紮することができるので、ヘルニア門Gの周辺の鼠径菅の構造に愛護的とされている。 In recent years, attention has been paid to a method of repairing a hernia by laparoscopic approach to the gap as a method capable of repairing the hernia without incising the cellular tissue around the inguinal region or the hernia gate G. Has been. Specifically, a laparoscope is inserted into the abdominal cavity AC of the patient's abdomen AR without incising the patient's body surface BS, and the hernia sac PP is ligated with sutures at the hernia gate G as shown in FIG. A method of ligation and closing (laparoscopic percutaneous extraperitoneal closure, hereinafter referred to as “LPEC method”) has attracted attention. The hernia repair method using a laparoscope, such as the LPEC method, differs from the direct suture method or mesh method in which a large incision is made from the body surface BS side to the structure of the inguinal canal where the external inguinal hernia develops. Since the hernia sac PP can be ligated with a suture without destroying the structure of the hernia sac, the structure of the inguinal fold around the hernia gate G is considered to be lovable.
特開2008-62077号公報JP 2008-62077 A
 しかし、腹腔鏡を用いたLPEC法を、特に成人が発症した腹部ヘルニアに対して適用した場合、成人のヘルニア門Gが大きいことや、ヘルニア門Gの周囲の筋膜等の組織が固く脆弱化していることから、高位結紮によりヘルニア嚢PPを単に縛っただけでは、ヘルニアが再発する虞がある。従って、LPEC法には、広範囲な切開および留置したプロテーゼに起因した生体への影響を抑えることはできるものの、例えば成人へ適用した際に、永続的なヘルニア嚢PPの閉鎖が困難であるという問題があった。 However, when the LPEC method using a laparoscope is applied to an abdominal hernia that has developed especially in an adult, the hernia portal G of the adult is large and the tissues such as fascia around the hernia G are hardened and weakened. Therefore, there is a risk that the hernia will recur if the hernia sac PP is simply tied by high ligation. Therefore, although the LPEC method can suppress the influence on a living body caused by a wide range of incisions and indwelling prostheses, it is difficult to permanently close the hernia sac PP when applied to an adult, for example. was there.
 そこで、本発明者は、広範囲な切開が不要で、且つ、留置したプロテーゼに起因した生体への影響を低減可能なLPEC法においてヘルニアの再発を十分に防止することができる手法を確立するために鋭意研究を行った。そして、本発明者は、LPEC法においてヘルニア嚢の閉鎖を補強することにより、例えば成人に適用した場合であってもヘルニアの再発を十分に防止し得るようにすることに着想した。そこで、本発明者は更に検討を重ね、LPEC法では、ヘルニア嚢を高位結紮した位置よりもヘルニア嚢の先端側(腹腔側とは反対側)は、閉じた空間となることから、その中にプロテーゼを固定して瘢痕組織を形成させ、ヘルニア嚢の内周面を接着させれば、当該プロテーゼやその瘢痕組織によって腹膜内に影響を与えることなく、ヘルニア嚢の閉鎖を補強することができることに着想した。そこで、本発明者は更に研究を重ね、ヘルニア門近傍の、高位結紮する位置に対してヘルニア嚢の先端側に固定するのに好適なプロテーゼの形状を見出して本発明を完成させた。 Therefore, the present inventor does not need a wide incision, and in order to establish a technique that can sufficiently prevent hernia recurrence in the LPEC method that can reduce the influence on the living body caused by the indwelling prosthesis. We conducted intensive research. The inventor of the present invention has come up with the idea of reinforcing hernia sac closure in the LPEC method so that recurrence of the hernia can be sufficiently prevented even when applied to an adult, for example. Therefore, the present inventor has further studied, and in the LPEC method, the distal end side of the hernia sac (the side opposite to the abdominal cavity side) becomes a closed space rather than the position where the hernia sac is ligated at a high position. By fixing the prosthesis to form scar tissue and adhering the inner peripheral surface of the hernia sac, it is possible to reinforce the closure of the hernia sac without affecting the peritoneum by the prosthesis or the scar tissue Inspired. Therefore, the present inventor has further researched and found the shape of a prosthesis suitable for fixing to the distal end side of the hernia sac in the vicinity of the hernia gate and the position where high ligation is performed, and completed the present invention.
 本発明のヘルニア修復用プロテーゼは、中空錐体状に形成されたメッシュ状シートよりなることを特徴とする。このように、メッシュ状シートで構成し、且つ、中空錐体状に形成したプロテーゼは、ヘルニア門を介して体表面側へ突出した腹膜部分(以下、「突出腹膜部分」とも称する。)よりなるヘルニア嚢の先端側に腹腔鏡下で挿入および固定し易い。従って、LPEC法を用いてヘルニアを修復する際に、ヘルニア嚢を結紮する位置よりもヘルニア嚢の先端側にプロテーゼを固定した後、プロテーゼ固定位置よりも腹腔側で当該突出腹膜部分を結紮すれば、腹膜内に影響を与えることなくプロテーゼでヘルニア嚢の閉鎖を補強し、ヘルニアの再発を十分に防止することができる。 The hernia repair prosthesis of the present invention is characterized by comprising a mesh sheet formed in a hollow cone shape. Thus, the prosthesis formed of a mesh-like sheet and formed in the shape of a hollow cone is composed of a peritoneum portion (hereinafter also referred to as “projection peritoneum portion”) protruding to the body surface side through the hernia gate. Easy to insert and fix under the laparoscope on the distal side of the hernia sac. Therefore, when repairing a hernia using the LPEC method, after fixing the prosthesis to the distal end side of the hernia sac rather than the position to ligate the hernia sac, ligating the protruding peritoneal portion on the abdominal side of the prosthesis fixing position Reinforce hernia sac closure with a prosthesis without affecting the peritoneum and prevent hernia recurrence sufficiently.
 ここで、本発明のヘルニア修復用プロテーゼは、1層のメッシュ状シートで構成されることが好ましい。このように、プロテーゼを1層のメッシュ状シートで構成することで、ヘルニア嚢の内側でプロテーゼが潰れやすくなり、ヘルニア嚢の閉鎖を効果的に補強することができる。 Here, the hernia repair prosthesis of the present invention is preferably composed of a single-layer mesh sheet. In this way, by configuring the prosthesis with a single-layer mesh sheet, the prosthesis is easily crushed inside the hernia sac, and the closure of the hernia sac can be effectively reinforced.
 さらに、本発明のヘルニア修復用プロテーゼは、軸線方向に直交する方向に沿って測った最大幅が10~30mmであり、且つ、軸線方向に沿って測った長さが、15~40mmであることが好ましい。
 また、本発明のヘルニア修復用プロテーゼは、前記メッシュ状シートの線径が0.15~0.35mmであることが好ましい。
 このように、プロテーゼを上記の寸法とすることで、ヘルニア嚢の内周面により密着した状態でプロテーゼを固定することができるので、ヘルニア嚢の閉鎖をより効果的に補強することができる。
Further, the hernia repair prosthesis according to the present invention has a maximum width measured along the direction orthogonal to the axial direction of 10 to 30 mm and a length measured along the axial direction of 15 to 40 mm. Is preferred.
In the hernia repair prosthesis of the present invention, the mesh sheet preferably has a wire diameter of 0.15 to 0.35 mm.
In this way, by setting the prosthesis to the above-described dimensions, the prosthesis can be fixed in a state in which the prosthesis is more closely attached to the inner peripheral surface of the hernia sac, so that the closure of the hernia sac can be more effectively reinforced.
 また、本発明のヘルニア修復用プロテーゼは、固定用目印を有することが好ましい。このように、固定用目印を設ければ、ヘルニア嚢の内側へのプロテーゼの固定を確実かつ容易に行うことができる。 The hernia repair prosthesis of the present invention preferably has a fixing mark. Thus, if the fixing mark is provided, the prosthesis can be fixed to the inside of the hernia sac reliably and easily.
 そして、本発明のヘルニア修復用プロテーゼは、腹腔側からヘルニア嚢内に挿入して使用することができる。 The hernia repair prosthesis of the present invention can be used by being inserted into the hernia sac from the abdominal side.
 本発明のヘルニア修復用プロテーゼによれば、生体への影響を低減可能なLPEC法においてヘルニアの再発を十分に防止することができる手法を提供することができる。 According to the prosthesis for repairing a hernia of the present invention, it is possible to provide a technique that can sufficiently prevent the recurrence of the hernia in the LPEC method that can reduce the influence on the living body.
腹壁の間隙部から腹腔内の臓器が逸脱した状態を示す一部断面図である。It is a partial cross section figure which shows the state which the organ in the abdominal cavity deviated from the gap | interval part of an abdominal wall. 従来例のメッシュ法を適用して、ヘルニア門から腹腔内の臓器が逸脱することを防止した状態を示す一部断面図である。It is a partial cross section figure which shows the state which applied the mesh method of the prior art example, and prevented the organ in the abdominal cavity from deviating from the hernia gate. 従来のLPEC法を適用して、ヘルニア門から腹腔内の臓器が逸脱することを防止した状態を示す一部断面図である。It is a partial sectional view showing the state where the conventional LPEC method was applied and the organ in the abdominal cavity was prevented from deviating from the hernia gate. 本発明のヘルニア修復用プロテーゼを用いたヘルニア修復法を説明するための図であり、(a)は、プロテーゼをヘルニア嚢に固定した状態を示す一部断面図であり、(b)は、プロテーゼを固定した後にヘルニア嚢を縮径した状態を示す一部断面図であり、(c)は、ヘルニア嚢を縮径した後にヘルニア嚢を結紮した状態を示す一部断面図である。It is a figure for demonstrating the hernia repair method using the prosthesis for the hernia repair of this invention, (a) is a partial cross section figure which shows the state which fixed the prosthesis to the hernia sac, (b) is a prosthesis It is a fragmentary sectional view which shows the state which diameter-reduced the hernia sac after fixing, and (c) is a fragmentary sectional view which shows the state which ligated the hernia sac after diameter-reducing the hernia sac. 図4(a)のa-a線に沿う断面図を示す。FIG. 5 shows a cross-sectional view along the line aa in FIG. 本発明のヘルニア修復用プロテーゼを示す斜視図である。It is a perspective view which shows the prosthesis for the hernia repair of this invention.
 以下、図面を参照しつつ、この発明の実施形態について説明する。
 本発明のヘルニア修復用プロテーゼは、腹腔を形成する腹壁の間隙部から腹腔内の臓器が逸脱することを防止するためのものである。具体的には、本発明のヘルニア修復用プロテーゼは、腹壁に間隙部が存在することにより腹腔内の臓器などが通常あるべき位置から体表面側に突出して発症する、所謂ヘルニアを修復するために用いることができる。なお、修復の対象とするヘルニアとしては、限定されるものではないが、例えば、人体の太ももの付け根部分である鼠径部付近で発症する、外鼠径ヘルニア、内鼠径ヘルニアおよび大腿ヘルニアなどの腹部ヘルニアが挙げられる。
 そして、本発明のヘルニア修復用プロテーゼは、中空錐体状に形成したメッシュ状シートよりなることを特徴とし、間隙部を介して体表面側に突出した腹膜の一部である突出腹膜部分(ヘルニア嚢)の内側に固定されるものである。
Hereinafter, embodiments of the present invention will be described with reference to the drawings.
The hernia repair prosthesis of the present invention is for preventing an organ in the abdominal cavity from deviating from the gap between the abdominal walls forming the abdominal cavity. Specifically, the hernia repair prosthesis of the present invention is for repairing a so-called hernia in which an organ in the abdominal cavity protrudes from the normal position to the surface of the body due to the presence of a gap in the abdominal wall. Can be used. The hernia to be repaired is not limited, but, for example, abdominal hernias such as external inguinal hernias, internal inguinal hernias, and femoral hernias that develop near the inguinal region that is the base of the thigh of the human body. Is mentioned.
The hernia repair prosthesis of the present invention is characterized by comprising a mesh sheet formed in a hollow cone shape, and a protruding peritoneal portion (hernia) which is a part of the peritoneum protruding to the body surface side through a gap. It is fixed inside the sac.
<ヘルニア修復法の説明>
 まず、本発明のヘルニア修復用プロテーゼを用いた新規なヘルニア修復法の一例について、図4を用いて説明する。具体的には、図4を参照しつつ、腹腔ACを形成する腹壁AWの間隙部Gから腹腔AC内の臓器IOが体表面BS側に突出して発症したヘルニアを、本発明のヘルニア修復用プロテーゼを使用して修復する方法について説明する。
 なお、以下のヘルニア修復法は、間隙部Gよりなるヘルニア門の径が30mm未満の軽度または中度のヘルニアに特に好適に用いることができる。
<Description of hernia repair method>
First, an example of a novel hernia repair method using the hernia repair prosthesis of the present invention will be described with reference to FIG. Specifically, referring to FIG. 4, a hernia in which an organ IO in the abdominal cavity AC protrudes from the gap G of the abdominal wall AW forming the abdominal cavity AC to the body surface BS side is treated as a hernia repair prosthesis of the present invention. How to repair using
In addition, the following hernia repairing methods can be used particularly suitably for mild or moderate hernias with a hernia gate composed of the gap G having a diameter of less than 30 mm.
 この修復法では、まず、腹部ARに、ヘルニア嚢PPを腹腔AC内側から観察するための腹腔鏡を挿入する腹腔鏡用孔と、ヘルニア嚢PPの結紮またはプロテーゼ2の腹腔AC内での移動などの腹腔AC内での各種操作を行うための操作手段(例えば、把持鉗子)を腹腔AC内に挿入するための操作用孔とを形成する。腹腔鏡用孔は、例えば腹部ARの臍を、尖刃メスを用いて3~10mm程度、好ましくは3~5mm程度の大きさに切開し、切開した場所を、例えば穿刺器具を用いて穿刺することで形成することができる。具体的には、腹腔鏡用孔は、腹腔AC内まで穿刺可能な針と、当該針を内部に挿入可能であり且つ組合せ状態で針の先端が突出する長さを有する外套管とを備える穿刺器具(例えば、トロッカー)を腹部ARの切開部に穿刺した後、針(トロッカー本体)を外套管(トロッカースリーブ)から取り除き、外套管(トロッカースリーブ)を腹部ARに貫通させた状態で留置することにより、形成することができる。また、操作用孔は、腹腔鏡用孔を形成し、次に、腹腔鏡用孔よりガスを注入して腹腔AC内を例えば1kPa程度の気腹圧にした後、例えば腹腔鏡用孔と同様な穿刺器具を用いて腹部ARを穿刺することで形成することができる。 In this repair method, first, a laparoscopic hole for inserting a laparoscope for observing the hernia sac PP from the abdominal cavity AC inside the abdomen AR, ligation of the hernia sac PP, or movement of the prosthesis 2 in the abdominal cavity AC, etc. The operation means (for example, grasping forceps) for performing various operations in the abdominal cavity AC is formed with an operation hole for inserting into the abdominal cavity AC. For the laparoscopic hole, for example, the umbilicus of the abdominal part AR is incised into a size of about 3 to 10 mm, preferably about 3 to 5 mm, using a scalpel blade, and the incised place is punctured using a puncture device, for example. Can be formed. Specifically, the laparoscopic hole includes a needle that can be punctured into the abdominal cavity AC, and an outer tube that can be inserted into the laparoscope and that has a length that allows the tip of the needle to protrude in a combined state. After puncturing an incision in the abdominal AR with a device (eg, trocar), the needle (trocar body) is removed from the outer tube (trocar sleeve) and placed with the outer tube (trocar sleeve) penetrating the abdomen AR. Can be formed. Further, the operation hole is formed as a laparoscopic hole, and then gas is injected from the laparoscopic hole so that the abdominal cavity pressure in the abdominal cavity AC is, for example, about 1 kPa. It can be formed by puncturing the abdomen AR using a simple puncture device.
 次いで、必要に応じて、腹腔AC内から逸脱した臓器を既知の手法で還納する。その後、本発明のヘルニア修復用プロテーゼであるプロテーゼ2を腹腔鏡用孔または操作用孔を通過させて腹腔AC内に導入して、腹腔AC内側からプロテーゼ2を操作手段でヘルニア嚢PPの内側に配置する。なお、プロテーゼ2を腹腔AC内に導入するに当っては、予め、間隙部Gの内径を測定することもできる。具体的には、測定手段、例えば所定の長さを有する縫合糸を間隙部Gの内側に配置し、腹腔鏡で観察しつつ当該測定手段と間隙部Gの大きさとを比較することで、間隙部Gの内径を測定することができる。間隙部Gの内径を予め測定することで、ヘルニア嚢PPの内側に固定するプロテーゼ2を、間隙部Gに対して適切な大きさにすることができる。 Then, if necessary, the organ that has deviated from the abdominal cavity AC is returned by a known method. Thereafter, the prosthesis 2 which is the prosthesis for repairing the hernia of the present invention is introduced into the abdominal cavity AC through the laparoscopic hole or the operation hole, and the prosthesis 2 from the abdominal cavity AC inside the hernia sac PP by the operation means. Deploy. When the prosthesis 2 is introduced into the abdominal cavity AC, the inner diameter of the gap G can be measured in advance. Specifically, a measuring means, for example, a suture having a predetermined length is placed inside the gap G, and the size of the measuring means is compared with the size of the gap G while observing with a laparoscope. The inner diameter of the part G can be measured. By measuring the inner diameter of the gap G in advance, the prosthesis 2 fixed inside the hernia sac PP can be appropriately sized with respect to the gap G.
 そして、ヘルニア嚢PPの内側に、腹腔鏡用孔または操作用孔を介してプロテーゼ2を配置した後、プロテーゼ2をヘルニア嚢PPに対して固定するとともに(図4(a)参照)、プロテーゼ2を固定した位置でヘルニア嚢PPをプロテーゼ2とともに縮径する(図4(b)参照)。ここで、プロテーゼ2のヘルニア嚢PPに対する固定およびヘルニア嚢PPの縮径は、プロテーゼ2をヘルニア嚢PPに対して縫合糸3で固定し、その縫合糸3を強く縛ることで行うことができる。なお、プロテーゼ2を縫合糸で固定した後、その縫合糸とは別の縫合糸3でヘルニア嚢PPを縮径することもできる。
 なお、プロテーゼ2のヘルニア嚢PPへの縫合は、任意の手段を用いて行うことができるが、腹腔鏡で腹腔AC内から観察しつつ、縫合糸を把持した状態で穿刺することが可能な針である縫合用針、例えば縫合糸パサーと、腹腔AC内に位置する操作手段とを用いることで行うことができる。具体的には、縫合用針の先端を、縫合糸3を把持した状態で体表面BS側から導入し、ヘルニア嚢PPを穿破して、プロテーゼ2を通して操作手段(例えば、把持鉗子)に縫合糸3を渡す。そして、操作手段に縫合糸3を渡した後、縫合糸3を離した縫合用針の先端を、ヘルニア嚢PP外へ引き戻しヘルニア嚢PPの外周を周方向に運針するなどして、移動させる。その後、運針した縫合用針を使用し、ヘルニア嚢PPを先ほどとは別の位置で穿破して、操作手段から縫合用針に縫合糸3を渡す。このように縫合用針と操作手段とによる縫合を繰り返して、例えば図5に示すように、ヘルニア嚢PPとプロテーゼ2とをその外周にわたって縫合した後、体表面BS側に縫合糸3の先端を出し、縫合糸3の先端側および後端側を結び合わせることで、プロテーゼ2をヘルニア嚢PPに対して固定することができる。また、縫合糸3の先端側および後端側を結び合わせる際に、その縫合糸3を強く縛ることで、ヘルニア嚢PPをプロテーゼ2とともに縮径することができる。なお、この段階では、ヘルニア嚢PPを縮径した後にヘルニア嚢PPが閉塞せずに若干開口した状態であってもよい。また、縫合糸3の、ヘルニア嚢PPおよびプロテーゼ2に対して通し方は、図5の方法に限定されず、任意に変更することができる。さらに、プロテーゼ2の固定およびヘルニア嚢PPの縮径のための縫合は、複数回行うことができる。
Then, after the prosthesis 2 is disposed inside the hernia sac PP via the laparoscopic hole or the operation hole, the prosthesis 2 is fixed to the hernia sac PP (see FIG. 4A), and the prosthesis 2 The hernia sac PP is reduced in diameter together with the prosthesis 2 at a position where is fixed (see FIG. 4B). Here, the fixation of the prosthesis 2 to the hernia sac PP and the diameter reduction of the hernia sac PP can be performed by fixing the prosthesis 2 to the hernia sac PP with the suture 3 and strongly binding the suture 3. In addition, after fixing the prosthesis 2 with a suture thread, the diameter of the hernia sac PP can be reduced with a suture thread 3 different from the suture thread.
The prosthesis 2 can be sutured to the hernia sac PP using any means, but a needle that can be punctured while grasping the suture while observing from the abdominal cavity AC with a laparoscope. Can be performed by using a suture needle such as a suture passer and an operating means located in the abdominal cavity AC. Specifically, the tip of the suturing needle is introduced from the body surface BS side while holding the suture thread 3, pierced through the hernia sac PP, and sutured to the operating means (for example, grasping forceps) through the prosthesis 2. Pass the thread 3. Then, after passing the suture thread 3 to the operating means, the distal end of the suture needle from which the suture thread 3 has been released is pulled out of the hernia sac PP and moved by moving the outer periphery of the hernia sac PP in the circumferential direction. Thereafter, the suture needle thus moved is used to puncture the hernia sac PP at a position different from the previous position, and the suture thread 3 is transferred from the operating means to the suture needle. As described above, for example, as shown in FIG. 5, the hernia sac PP and the prosthesis 2 are sutured over the outer periphery thereof, and then the tip of the suture 3 is placed on the body surface BS side. The prosthesis 2 can be fixed to the hernia sac PP by taking out and combining the front end side and the rear end side of the suture thread 3. Further, when the distal end side and the rear end side of the suture thread 3 are tied together, the hernia sac PP can be reduced in diameter together with the prosthesis 2 by tightly binding the suture thread 3. At this stage, the hernia sac PP may be slightly opened without being blocked after the hernia sac PP is reduced in diameter. Moreover, how the suture thread 3 passes through the hernia sac PP and the prosthesis 2 is not limited to the method of FIG. 5 and can be arbitrarily changed. Furthermore, the suture for fixing the prosthesis 2 and reducing the diameter of the hernia sac PP can be performed a plurality of times.
 さらに、ヘルニア嚢PPをプロテーゼ2とともに縮径した後、プロテーゼ2の固定位置よりも腹腔AC内側の位置でヘルニア嚢PPを縫合し結紮する(図5(c)参照)。ヘルニア嚢PPの結紮は、従来のLPEC法において用いられている既知の手法を用いて行うことができ、例えば、腹腔鏡で腹腔AC内から観察しつつ、縫合用針と操作手段とを用いることで行うことができる。具体的には、縫合用針の先端を、縫合糸4を把持した状態で体表面BS側から導入し、ヘルニア嚢PPの、プロテーゼ2よりも腹腔AC側の外周を周方向一方側へ運針させてヘルニア嚢PPを穿破して、操作手段(例えば、把持鉗子)に縫合糸4を渡す。そして、縫合糸4を離した縫合用針の先端を、ヘルニア嚢PP外へ引き戻しヘルニア嚢PPの外周を周方向他方側に運針させてヘルニア嚢PPを縫合糸4が貫通した位置とは別の位置で穿破させて、操作手段から縫合用針に縫合糸4を渡す。縫合糸4を、ヘルニア嚢PPの外周にわたって通した後、体表面BS側に縫合糸4の先端を出し、縫合糸4の先端側および後端側を結び合わせて強く縛ることで、ヘルニア嚢PPを結紮して閉鎖することができる。なお、ヘルニア嚢PPの結紮のための縫合は、複数回行うことができる。
 なお、ヘルニア門を有効に閉鎖する観点から、ヘルニア嚢PPの結紮位置は、間隙部Gの腹腔AC側の開口部であることが好ましい。また、ヘルニア嚢PPの閉鎖を有効に補強する観点から、プロテーゼ2のヘルニア嚢PPへの固定は、ヘルニア嚢PPを結紮し閉鎖する位置よりも、ヘルニア嚢PPの先端側(腹腔AC側とは反対側)に5~10mm移動した位置であることが好ましい。
Furthermore, after reducing the diameter of the hernia sac PP together with the prosthesis 2, the hernia sac PP is sutured and ligated at a position inside the abdominal cavity AC from the fixed position of the prosthesis 2 (see FIG. 5C). The ligation of the hernia sac PP can be performed using a known method used in the conventional LPEC method, for example, using a suture needle and operation means while observing from the abdominal cavity AC with a laparoscope Can be done. Specifically, the distal end of the suture needle is introduced from the body surface BS side with the suture thread 4 held, and the outer circumference of the hernia sac PP on the abdominal cavity AC side of the prosthesis 2 is moved to one side in the circumferential direction. Then, the hernia sac PP is pierced and the suture 4 is passed to the operating means (for example, grasping forceps). Then, the tip of the suture needle from which the suture thread 4 has been released is pulled back out of the hernia sac PP, and the outer periphery of the hernia sac PP is moved to the other side in the circumferential direction. The suture thread 4 is passed through the operating means to the suturing needle. After passing the suture thread 4 over the outer periphery of the hernia sac PP, the distal end of the suture thread 4 is put out on the body surface BS side, and the distal end side and the rear end side of the suture thread 4 are tied together and tied tightly. Can be ligated and closed. The suturing for ligation of the hernia sac PP can be performed a plurality of times.
In addition, from the viewpoint of effectively closing the hernia gate, the ligation position of the hernia sac PP is preferably an opening on the abdominal cavity AC side of the gap G. In addition, from the viewpoint of effectively reinforcing the closure of the hernia sac PP, the prosthesis 2 is fixed to the hernia sac PP more than the position where the hernia sac PP is ligated and closed. The position is preferably 5 to 10 mm moved to the opposite side).
 ヘルニア嚢PPを閉鎖した後、腹腔鏡および操作手段を腹腔AC内から抜き出し、腹腔鏡用孔および操作用孔を閉鎖する。なお、腹腔鏡および操作手段を腹腔AC内から抜き出す前に、腹腔鏡での観察を行い、腹腔AC内に別のヘルニア嚢PPが存在すれば、当該ヘルニア嚢PPを結紮し閉鎖することもできる。 After closing the hernia sac PP, the laparoscope and the operation means are extracted from the abdominal cavity AC, and the laparoscope hole and the operation hole are closed. Before the laparoscope and the operation means are extracted from the abdominal cavity AC, observation with a laparoscope is performed, and if another hernia sac PP exists in the abdominal cavity AC, the hernia sac PP can be ligated and closed. .
 上述したヘルニア修復法による作用・効果を説明する。
 このヘルニア修復法によれば、腹腔鏡を用いつつ、体表面BS側から導入する縫合用針および腹腔AC内に挿入する操作手段を用いることにより、体表面BSを大きく切開せずにヘルニア嚢PPを縫合糸で結紮して閉鎖しているので、間隙部Gの周囲の細胞組織構造を破壊することなくヘルニアを修復し、間隙部Gから腹腔AC内の臓器IOが逸脱することを防止することができる。すなわち、直接縫合法や従来のメッシュ法と比較して、細胞組織構造を破壊することなくヘルニアを修復することができる。従って、患者への肉体的な負担が少なく、早期の回復および退院を実現することができる。
 また、このヘルニア修復法によれば、ヘルニア嚢PPを縫合糸で結紮して閉鎖するにあたって、プロテーゼ2をヘルニア嚢PPに対して固定するとともに、プロテーゼ2を固定よびヘルニア嚢PPの内周面を密着させているので、ヘルニア嚢PP内でプロテーゼ2と一体化するように瘢痕組織を形成させることができる。それゆえに、瘢痕組織が、ヘルニア嚢PPの内周面を有効に接着するので、プロテーゼ2を用いない場合(即ち、従来の一般的なLPEC法)と比較して、ヘルニア嚢PPの閉鎖を補強することができる。また、従来のメッシュ法に比べて瘢痕組織が小さく、且つ、瘢痕組織がヘルニア嚢PPの閉じた空間に形成されるので、従来のメッシュ法を採用した場合に起こり得る、メッシュプラグ等による腹腔AC内の臓器IOの損傷の可能性を低減させることができる。
 よって、この修復法によれば、プロテーゼ2の留置による生体への影響を低減させつつ、腹腔ACを形成する腹壁AWの間隙部Gから腹腔AC内の臓器IOが再び逸脱することを十分に防止することができる。
The operation and effect of the above-described hernia repair method will be described.
According to this hernia repair method, the hernia sac PP is used without greatly incising the body surface BS by using the suture needle introduced from the body surface BS side and the operation means inserted into the abdominal cavity AC while using the laparoscope. Since the hernia is repaired without damaging the cellular tissue structure around the gap G, the organ IO in the abdominal cavity AC is prevented from deviating from the gap G. Can do. That is, the hernia can be repaired without destroying the cell tissue structure as compared with the direct suture method or the conventional mesh method. Therefore, there is little physical burden on the patient, and early recovery and discharge can be realized.
Further, according to this hernia repair method, when the hernia sac PP is ligated and closed with a suture, the prosthesis 2 is fixed to the hernia sac PP, and the prosthesis 2 is fixed and the inner peripheral surface of the hernia sac PP is fixed. Because of the close contact, scar tissue can be formed so as to be integrated with the prosthesis 2 in the hernia sac PP. Therefore, since the scar tissue effectively adheres to the inner peripheral surface of the hernia sac PP, the closure of the hernia sac PP is reinforced compared to the case where the prosthesis 2 is not used (that is, the conventional general LPEC method). can do. In addition, since the scar tissue is smaller than the conventional mesh method and the scar tissue is formed in a closed space of the hernia sac PP, an abdominal cavity AC using a mesh plug or the like that may occur when the conventional mesh method is adopted. The possibility of damage to the internal organ IO can be reduced.
Therefore, according to this repair method, the organ IO in the abdominal cavity AC is sufficiently prevented from deviating again from the gap G of the abdominal wall AW forming the abdominal cavity AC while reducing the influence on the living body due to the placement of the prosthesis 2. can do.
 なお、この修復法は、間隙部Gの大きさにかかわらず適用することができるが、腹腔AC内の臓器IOが逸脱することを効果的に防止する観点からは、径が30mm未満の間隙部Gである場合に適用することが好ましい。 This repair method can be applied regardless of the size of the gap G. From the viewpoint of effectively preventing the organ IO in the abdominal cavity AC from deviating, the gap having a diameter of less than 30 mm is used. It is preferable to apply when G.
 そして、上記の修復法では、プロテーゼ2として後述する本発明のヘルニア修復用プロテーゼを好適に用いることができる。また、上記の修復法は、患者の年齢によらず用いることができ、更に、人体に限らず動物にも適用することができる。 In the above repair method, the hernia repair prosthesis of the present invention described later can be suitably used as the prosthesis 2. In addition, the above repair method can be used regardless of the age of the patient, and can be applied not only to the human body but also to animals.
<ヘルニア修復用プロテーゼの説明>
 次に、上記の修復法に好適に用い得る本発明のヘルニア修復用プロテーゼの一例であるプロテーゼ5について、図6を用いて説明する。
<Description of hernia repair prosthesis>
Next, a prosthesis 5 that is an example of the hernia repair prosthesis of the present invention that can be suitably used in the above repair method will be described with reference to FIG.
 本発明のヘルニア修復用プロテーゼの一例であるプロテーゼ5は、生体適合性を有するメッシュ状シートで構成されている。そして、プロテーゼ5は、図6に示すように、当該プロテーゼ5の内部に空洞7を有する錐体状(即ち、中空錐体状)であり、換言すれば、軸線方向一端8側(図6では右側)の、軸線方向に直交する断面積が、軸線方向他端9側(図6では左側)の断面積よりも大きくなっている。 The prosthesis 5 which is an example of the hernia repair prosthesis of the present invention is configured by a mesh-like sheet having biocompatibility. As shown in FIG. 6, the prosthesis 5 has a cone shape having a cavity 7 inside the prosthesis 5 (that is, a hollow cone shape), in other words, one end 8 side in the axial direction (in FIG. 6). On the right side, the cross-sectional area orthogonal to the axial direction is larger than the cross-sectional area on the other axial end 9 side (left side in FIG. 6).
 そして、プロテーゼ5は、1層以上のメッシュ状シート(図示例では1層のメッシュ状シート)で構成されている。
 具体的には、プロテーゼ5は、1枚のメッシュ状シートを円錐形に屈曲させ、生体適合性を有する糸(例えば、縫合用糸など)を用いてメッシュ状シートの重なり合った部分を縛って固定することにより、或いは、重なり合った部分を熱融着することにより、中空錐体状に形成されている。
And the prosthesis 5 is comprised by the mesh-like sheet | seat of 1 layer or more (in the example of illustration, 1 layer mesh-like sheet | seat).
Specifically, the prosthesis 5 is formed by bending a single mesh sheet into a conical shape, and using a biocompatible thread (for example, a suture thread) to bind and overlap the overlapping portions of the mesh sheet. By doing so or by heat-sealing the overlapped portion, it is formed in a hollow cone shape.
 なお、メッシュ状シートとしては、生体適合性を有する材料、例えば、ポリエチレン、ポリプロピレンもしくはそれらの混合物よりなるメッシュ状シート、または、それらの樹脂よりなるメッシュ部材に例えばチタンなどをコーティングしてなるメッシュ状シートを用いることができる。 As the mesh sheet, a biocompatible material, for example, a mesh sheet made of polyethylene, polypropylene or a mixture thereof, or a mesh formed by coating a mesh member made of such resin with, for example, titanium or the like. A sheet can be used.
 また、図6に示すように、プロテーゼ5には、ヘルニア嚢PPへのプロテーゼ5の固定を容易にするための固定用目印Mが設けられている。具体的には、プロテーゼ5の軸線方向一端8側には、一端側部分の周囲に1つ以上(図示例では4つ)の目印Mが設けられている。また、プロテーゼ5の外周面上には、錐体の頂点から底面の外周縁に向かって延びる目印Mも設けられている。なお、図6に示す例では、目印Mとして、一端側部分の周囲の1つ以上の目印と、錐体の頂点から底面の外周縁に向かって延びる目印との双方を設けたが、目印Mは、一端側部分の周囲の1つ以上の目印のみとしてもよいし、錐体の頂点から底面の外周縁に向かって延びる目印のみにしてもよい。
 ここで、目印Mは、メッシュ状シートを着色することにより形成してもよいし、メッシュ状シートとは異なる色を有し、且つ、生体適合性を有する糸(例えば、縫合用糸など)をメッシュ状シートに縛って固定することにより形成してもよい。なお、前述したように、メッシュ状シートを屈曲させ、生体適合性を有する糸で固定することにより中空錐体状のプロテーゼを形成する場合には、メッシュ状シートの固定に用いた糸をメッシュ状シートとは異なる色の糸とすることにより、固定用の糸を目印Mとしても機能させることができる。このように、固定用の糸を目印Mとして機能させれば、簡素な構成を用いて目印Mを低コストで設けることができる。
As shown in FIG. 6, the prosthesis 5 is provided with a fixing mark M for facilitating the fixation of the prosthesis 5 to the hernia sac PP. Specifically, one or more (four in the illustrated example) marks M are provided around one end side portion on the axial one end 8 side of the prosthesis 5. Further, on the outer peripheral surface of the prosthesis 5, a mark M extending from the apex of the cone toward the outer peripheral edge of the bottom surface is also provided. In the example shown in FIG. 6, as the mark M, both one or more marks around the one end side portion and a mark extending from the apex of the cone toward the outer peripheral edge of the bottom surface are provided. May be only one or more marks around the one end side portion, or may be only marks extending from the apex of the cone toward the outer peripheral edge of the bottom surface.
Here, the mark M may be formed by coloring the mesh sheet, or a thread having a color different from that of the mesh sheet and having biocompatibility (for example, a suture thread). You may form by tying and fixing to a mesh-like sheet. As described above, when forming a hollow cone-shaped prosthesis by bending the mesh sheet and fixing with a biocompatible thread, the thread used for fixing the mesh sheet is mesh-shaped. By using a thread having a color different from that of the sheet, the fixing thread can also function as the mark M. Thus, if the fixing thread functions as the mark M, the mark M can be provided at a low cost using a simple configuration.
 ここで、上述したプロテーゼ5を前述した新規なヘルニア修復法に使用した際に得られる作用・効果を説明する。
 プロテーゼ5は、中空錐体状であるので、前述した新規なヘルニア修復法に使用した際に、腹腔AC内の狭い空間内であっても、プロテーゼ5を、腹腔AC内側からヘルニア嚢PPの内側に容易に挿入して配置することができる。特に、中空錐体状のプロテーゼ5は、把持鉗子などの操作手段を用いて内周面側から保持した状態で移動させることができると共に、断面積の小さい軸線方向他端9側からヘルニア門を介してヘルニア嚢PP内に容易に挿入させることができる。
Here, actions and effects obtained when the above-described prosthesis 5 is used in the above-described novel hernia repair method will be described.
Since the prosthesis 5 has a hollow cone shape, when used in the above-described novel hernia repair method, the prosthesis 5 is moved from the inner side of the abdominal cavity AC to the inner side of the hernia sac PP even in a narrow space in the abdominal cavity AC. Can be easily inserted and arranged. In particular, the hollow cone-shaped prosthesis 5 can be moved while being held from the inner peripheral surface side using an operation means such as a grasping forceps, and the hernia gate can be moved from the other axial end 9 side having a small cross-sectional area. And can be easily inserted into the hernia sac PP.
 また、プロテーゼ5は、メッシュ状シートで形成していることから、プロテーゼ5をヘルニア嚢PPに容易に縫合することができる。また、プロテーゼ5は、中空状であることから、小さく折り畳んだ状態で、腹腔鏡用孔または操作用孔から腹腔AC内へと容易に挿入することができる。更に、中空状のプロテーゼ5は、図4(a)~(b)に示すようにヘルニア嚢PPをプロテーゼとともに縮径する際に、プロテーゼ5の変形によって過剰な反力を生じることがない。従って、前述したヘルニア修復法に用いた際に、ヘルニア嚢PPとプロテーゼ5とを、プロテーゼ5をヘルニア嚢PPの内周面の形状に合わせた状態で密着させることができる。さらに、プロテーゼ5が、生体適合性のメッシュ状シートであるので、細胞がメッシュ状構造を足場に、プロテーゼ5に対して密に瘢痕組織を形成することができる。したがって、ヘルニア嚢PPの内周面を有効に接着させることができる。 Further, since the prosthesis 5 is formed of a mesh sheet, the prosthesis 5 can be easily sutured to the hernia sac PP. Further, since the prosthesis 5 is hollow, it can be easily inserted into the abdominal cavity AC through a laparoscopic hole or an operation hole in a small folded state. Furthermore, the hollow prosthesis 5 does not generate excessive reaction force due to deformation of the prosthesis 5 when the hernia sac PP is reduced in diameter together with the prosthesis as shown in FIGS. 4 (a) to 4 (b). Therefore, when used in the above-described hernia repair method, the hernia sac PP and the prosthesis 5 can be brought into close contact with the prosthesis 5 in a state of matching the shape of the inner peripheral surface of the hernia sac PP. Furthermore, since the prosthesis 5 is a biocompatible mesh sheet, cells can form scar tissue densely with respect to the prosthesis 5 using the mesh structure as a scaffold. Therefore, the inner peripheral surface of the hernia sac PP can be effectively adhered.
 なお、プロテーゼ5を、内部に空洞7を有しない形状、例えば、前述した特許文献1に記載されるようなメッシュプラグ状(プラグ形状を補強してメッシュプラグ自体の嵩を増すような複数のメッシュを内部に備える中実構造)にすると、小さく折り畳むことができず、腹腔鏡用孔または操作用孔から腹腔AC内へと挿入することが困難になる。また、プロテーゼ5を中実構造にすると、プロテーゼ5のヘルニア嚢PPへの縫合が困難になると共に、ヘルニア嚢PPを縮径する際に、内部のメッシュの存在により過剰な反力を生じ、ヘルニア嚢PPの内周面を閉鎖しにくくなる。 The prosthesis 5 has a shape that does not have a cavity 7 inside, for example, a mesh plug shape as described in Patent Document 1 described above (a plurality of meshes that reinforce the plug shape and increase the bulk of the mesh plug itself. If it is made a solid structure), it cannot be folded small, and it becomes difficult to insert it into the abdominal cavity AC from the laparoscopic hole or the operation hole. In addition, when the prosthesis 5 has a solid structure, it becomes difficult to suture the prosthesis 5 to the hernia sac PP, and when the hernia sac PP is reduced in diameter, an excessive reaction force is generated due to the presence of an internal mesh. It becomes difficult to close the inner peripheral surface of the sac PP.
 ここで、プロテーゼ5を折り畳み易くして腹腔鏡用孔または操作用孔を介した腹腔AC内への挿入を更に容易にすると共に、ヘルニア嚢PPの内周面への密着性を高める観点からは、メッシュ状シートの線径は0.15~0.35mmとすることが好ましい。メッシュ状シートの線径を0.35mm以下にすれば、メッシュ状シートの曲げ剛性が小さくなって、折り畳みが容易になると共に、ヘルニア嚢PPの内周面への密着性が高まる。なお、メッシュ状シートの線径を0.15mm以上にすれば、強度を確保することができる。
 また、同様の理由により、メッシュ状シートの開口径は、1.0mm~2.0mmであることが好ましい。メッシュ状シートの開口径を1.0mm以上にすれば、メッシュ状シートの曲げ剛性が小さくなって、折り畳みが容易になると共に、ヘルニア嚢PPの内周面への密着性が高まる。なお、メッシュ状シートの開口径を2.0mm以下にすれば、強度を確保することができる。
Here, from the viewpoint of making the prosthesis 5 easy to fold and facilitating the insertion into the abdominal cavity AC through the laparoscopic hole or the operation hole, and improving the adhesion to the inner peripheral surface of the hernia sac PP The wire diameter of the mesh sheet is preferably 0.15 to 0.35 mm. When the wire diameter of the mesh sheet is set to 0.35 mm or less, the bending rigidity of the mesh sheet is reduced, the folding is facilitated, and the adhesion to the inner peripheral surface of the hernia sac PP is increased. In addition, if the wire diameter of the mesh sheet is 0.15 mm or more, the strength can be ensured.
For the same reason, the opening diameter of the mesh sheet is preferably 1.0 mm to 2.0 mm. When the opening diameter of the mesh sheet is set to 1.0 mm or more, the bending rigidity of the mesh sheet is reduced, the folding becomes easy, and the adhesion to the inner peripheral surface of the hernia sac PP is increased. In addition, if the opening diameter of the mesh sheet is 2.0 mm or less, the strength can be ensured.
 更に、上述したプロテーゼ5は、目印Mを有しているので、ヘルニア嚢PPに対してプロテーゼ5を縫合し、固定する際に、腹腔鏡を用いて縫合する位置を容易に確認することができる。特に、プロテーゼ5は、中空状であり、ヘルニア嚢PP内に設置する際に潰れてプロテーゼ5の内周面同士が接触する等して適切な縫合位置が把握し難くなり易いところ、目印Mを設ければ、適切な位置でプロテーゼ5をヘルニア嚢PPに固定することができる。 Furthermore, since the prosthesis 5 described above has the mark M, when the prosthesis 5 is sutured and fixed to the hernia sac PP, the position to be sutured can be easily confirmed using a laparoscope. . In particular, the prosthesis 5 is hollow, and when it is placed in the hernia sac PP, the prosthesis 5 is crushed and the inner peripheral surfaces of the prosthesis 5 are in contact with each other. If provided, the prosthesis 5 can be fixed to the hernia sac PP at an appropriate position.
 ここで、ヘルニア嚢PPへのプロテーゼ5の固定の容易性を向上する観点からは、プロテーゼ5には、ヘルニア嚢PP内へ設置するまでプロテーゼ5の形状を保持する補強部材を設けてもよい。補強部材を設ければ、例えばプロテーゼ5を腹腔AC内に導入する際に折り畳んでも、腹腔AC内にプロテーゼ5を導入した後、速やかに潰れた状態を解消することができる。従って、プロテーゼ5をヘルニア嚢PP内に設置する際にプロテーゼ5の内周面同士が接触する等して適切な縫合位置が把握し難くなるのを防止することができる。
 なお、補強部材としては、生体適合性を有しており、且つ、ヘルニア嚢PPの縮径を妨げるような大きな反力を発揮しないものであれば限定されることはなく、例えばリング状の部材を用いることができる。
Here, from the viewpoint of improving the ease of fixing the prosthesis 5 to the hernia sac PP, the prosthesis 5 may be provided with a reinforcing member that holds the shape of the prosthesis 5 until it is installed in the hernia sac PP. If the reinforcing member is provided, for example, even when the prosthesis 5 is folded into the abdominal cavity AC, the collapsed state can be quickly eliminated after the prosthesis 5 is introduced into the abdominal cavity AC. Therefore, when the prosthesis 5 is installed in the hernia sac PP, it is possible to prevent an appropriate suture position from becoming difficult to grasp due to contact between the inner peripheral surfaces of the prosthesis 5 or the like.
The reinforcing member is not limited as long as it has biocompatibility and does not exhibit a large reaction force that prevents the diameter reduction of the hernia sac PP. For example, a ring-shaped member Can be used.
 また、プロテーゼ5をヘルニア嚢PPの内周面により密着した状態で固定し、ヘルニア嚢PPの閉鎖をより効果的に補強し得るようにする観点からは、プロテーゼ5を用いる際、間隙部Gの径に合わせた大きさのプロテーゼ5にすることが好ましい。従って、プロテーゼ5は、軸線方向に直交する方向に沿って測った最大幅Wを、10~30mmとし、また、軸線方向に沿って測った長さDを、15~40mmとすることが好ましい。なお、図示例では、軸線方向一端8が最大幅Wとなっている。 Further, from the viewpoint of fixing the prosthesis 5 in a state in which the prosthesis 5 is in close contact with the inner peripheral surface of the hernia sac PP, so that the closure of the hernia sac PP can be more effectively reinforced, when the prosthesis 5 is used, The prosthesis 5 is preferably sized according to the diameter. Therefore, it is preferable that the prosthesis 5 has a maximum width W measured along the direction orthogonal to the axial direction of 10 to 30 mm, and a length D measured along the axial direction of 15 to 40 mm. In the illustrated example, one end 8 in the axial direction has a maximum width W.
 以上、図面を参照して本発明の実施形態を説明したが、本発明のヘルニア修復用プロテーゼは、上記の例に限定されることは無く、適宜変更を加えることができる。 As mentioned above, although embodiment of this invention was described with reference to drawings, the prosthesis for hernia repair of this invention is not limited to said example, A change can be added suitably.
 具体的には、プロテーゼは、その内部に空洞がある中空錐体状であれば任意の形状にすることができる。具体的には、プロテーゼの形状は、図6に示すような円錐(コーン型)の他、三角錐、四角錐などの多角錐、或いは、楕円錐であってもよい。また、プロテーゼの形状は、截頭錐体であってもよい。更に、図6に示すプロテーゼ5は、軸線方向一端8側のみが開口しているが、プロテーゼは、軸線方向他端側が開口していてもよい。 Specifically, the prosthesis can have any shape as long as it has a hollow cone shape with a cavity inside. Specifically, the shape of the prosthesis may be a cone (cone shape) as shown in FIG. 6, a polygonal pyramid such as a triangular pyramid, a quadrangular pyramid, or an elliptical pyramid. Further, the shape of the prosthesis may be a truncated cone. Furthermore, although the prosthesis 5 shown in FIG. 6 is open only at one axial end 8 side, the prosthesis may be open at the other axial end.
 また、プロテーゼは、多層のメッシュ状シートで構成されていてもよい。但し、ヘルニア嚢をプロテーゼとともに縮径する際の反力の発生を抑制する観点、ヘルニア嚢の内周面への密着性の観点、および、腹腔内への挿入性の観点からは、プロテーゼは1層のメッシュ状シートで構成することが好ましい。 Further, the prosthesis may be composed of a multilayer mesh sheet. However, from the viewpoint of suppressing the generation of reaction force when the hernia sac is contracted with the prosthesis, the viewpoint of adhesion to the inner peripheral surface of the hernia sac, and the insertion property into the abdominal cavity, the prosthesis is 1 It is preferable to comprise a layered mesh sheet.
 更に、プロテーゼは、一体成形により錐体状に形成してもよいが、コストおよび生体への適合性の観点からは、1枚のメッシュ状シートを円錐形に屈曲させ、縫合用糸などを用いて固定することにより錐体状に形成することが好ましい。 Further, the prosthesis may be formed into a cone shape by integral molding, but from the viewpoint of cost and compatibility with a living body, one mesh sheet is bent into a conical shape, and a suture thread or the like is used. It is preferable to form a cone by fixing them.
 本発明のヘルニア修復用プロテーゼによれば、生体への影響を低減可能なLPEC法においてヘルニアの再発を十分に防止することができる手法を提供することができる。 According to the prosthesis for repairing a hernia of the present invention, it is possible to provide a technique that can sufficiently prevent the recurrence of the hernia in the LPEC method that can reduce the influence on the living body.
1 メッシュ
1a シート状メッシュ
1b メッシュプラグ
2 プロテーゼ
3、4 縫合糸
5 ヘルニア修復用プロテーゼ
6 メッシュ状シート
7 空洞
8 一端
9 他端
AC 腹腔
AR 腹部
AW 腹壁
BS 体表面
D 軸線方向に沿って測った長さ
G 間隙部(ヘルニア門)
IO 臓器
M 目印
OG 開口部
P 腹膜
PP 突出腹膜部分(ヘルニア嚢)
W 軸線方向に直交する方向に沿って測った最大幅
1 mesh 1a sheet-like mesh 1b mesh plug 2 prosthesis 3, 4 suture 5 hernia repair prosthesis 6 mesh-like sheet 7 cavity 8 one end 9 other end AC abdominal cavity AR abdominal AW abdominal wall BS body surface D length measured along the axial direction G gap (hernia gate)
IO Organ M Marking OG Opening P Peritoneum PP Protruding peritoneum (hernia sac)
W Maximum width measured along the direction perpendicular to the axial direction

Claims (6)

  1.  中空錐体状に形成されたメッシュ状シートよりなることを特徴とする、ヘルニア修復用プロテーゼ。 A hernia repair prosthesis comprising a mesh-like sheet formed in a hollow cone shape.
  2.  1層のメッシュ状シートで構成されることを特徴とする、請求項1に記載のヘルニア修復用プロテーゼ。 2. The hernia repair prosthesis according to claim 1, wherein the prosthesis is a single-layer mesh sheet.
  3.  軸線方向に直交する方向に沿って測った最大幅が10~30mmであり、且つ、軸線方向に沿って測った長さが15~40mmであることを特徴とする、請求項1または2に記載のヘルニア修復用プロテーゼ。 3. The maximum width measured along the direction orthogonal to the axial direction is 10 to 30 mm, and the length measured along the axial direction is 15 to 40 mm. Hernia repair prosthesis.
  4.  固定用目印を有することを特徴とする、請求項1~3のいずれかに記載のヘルニア修復用プロテーゼ。 The hernia repair prosthesis according to any one of claims 1 to 3, further comprising a fixing mark.
  5.  前記メッシュ状シートの線径が0.15~0.35mmであることを特徴とする、請求項1~4のいずれかに記載のヘルニア修復用プロテーゼ。 The hernia repair prosthesis according to any one of claims 1 to 4, wherein the mesh sheet has a wire diameter of 0.15 to 0.35 mm.
  6.  腹腔側からヘルニア嚢内に挿入して使用されることを特徴とする、請求項1~5のいずれかに記載のヘルニア修復用プロテーゼ。 The hernia repair prosthesis according to any one of claims 1 to 5, wherein the prosthesis is used by being inserted into the hernia sac from the abdominal cavity side.
PCT/JP2013/006218 2013-10-21 2013-10-21 Prosthesis for repairing hernia WO2015059733A1 (en)

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JPH07430A (en) * 1993-02-05 1995-01-06 C R Bard Inc Implant-type prosthesis for restoring defective part of tissue or muscular wall and its restoring method
JPH11192248A (en) * 1997-08-27 1999-07-21 Ethnor Sa Prosthetic plug unit for hernia duct plugging
WO2001085060A1 (en) * 2000-05-05 2001-11-15 Cousin Biotech Hernia repair prosthesis
JP2004504100A (en) * 2000-07-25 2004-02-12 シー・アール・バード・インコーポレーテッド Implantable prosthesis
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