WO2010087330A1 - Retractor for flexible endoscope - Google Patents

Retractor for flexible endoscope Download PDF

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Publication number
WO2010087330A1
WO2010087330A1 PCT/JP2010/050963 JP2010050963W WO2010087330A1 WO 2010087330 A1 WO2010087330 A1 WO 2010087330A1 JP 2010050963 W JP2010050963 W JP 2010050963W WO 2010087330 A1 WO2010087330 A1 WO 2010087330A1
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WIPO (PCT)
Prior art keywords
retractor
lumen
shape
exclusion
instrument channel
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PCT/JP2010/050963
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French (fr)
Japanese (ja)
Inventor
清一 中島
俊朗 西田
大人 相馬
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国立大学法人大阪大学
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Publication of WO2010087330A1 publication Critical patent/WO2010087330A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/0218Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery

Definitions

  • the present invention in an endoscopic surgical operation, moves an operation target organ to an appropriate visual field, and controls an organ that obstructs the surgical field by squeezing out and pulling to secure an intraoperative visual field (surgical field).
  • the present invention relates to a retractor for a flexible endoscope.
  • test laparotomy In clinical departments, direct observation and treatment of body cavities are performed for the purpose of diagnosis for various disease states, determination of therapeutic effects, determination of therapeutic strategies, and the like. Conventionally, these have been performed by a large invasive approach called test laparotomy or test thoracotomy. However, with the spread of endoscopic surgery in recent years, it has come to be performed with a test laparoscope or a test thoracoscope with a smaller incision.
  • Patent Documents 1 and 2 describe a trocar system that can provide a passage through which a larger diameter surgical instrument can be easily expanded after penetrating the skin with a small diameter and inserting it into a body cavity. Is disclosed. According to this system, compared with the conventional case where a large incision corresponding to the diameter of the surgical instrument is made, the trauma of the patient is small, and the recovery time is very short.
  • NOTES Natural Orifice Translumenal Endoscopic Surgery
  • NOTES Natural Orifice Translumenal Endoscopic Surgery
  • the treatment instrument is inserted through a channel of 1.2 mm to 3.0 mm provided in the flexible endoscope, The operation of grasping and pulling the mesenchyme is performed.
  • assistance with laparoscopic forceps is performed, and therefore, only partial NOTES can be performed instead of complete NOTES.
  • a retractor is an instrument mainly used to secure a surgical field by moving the position of a tissue to be operated into an appropriate surgical field or by excluding or pulling a tissue that obstructs the surgical field.
  • the retractor is required to be able to insert a device through a small opening passage such as a trocar (outer tube) or a small incision as an insertion passage when the retractor is inserted into the body. Therefore, it is necessary to have a small diameter at least at the time of insertion (for example, 10 mm or less for a trocar, and preferably 20 mm or less for a small incision) and a rod-like form.
  • the excluding portion be deformable into a shape having a certain large area.
  • a tip portion having a loop shape for example, Patent Document 6
  • This is a type in which a small-diameter loop is taken out from the distal end of the tube, and the tissue is clamped and pulled by the loop. Although it can be inserted from a small-sized trocar and is extremely minimally invasive, it cannot be adapted to exclusion.
  • an evacuation portion comprising a sheet of rubber elastic thin film and a frame that substantially surrounds and surrounds the periphery of the sheet is extended to the evacuation portion.
  • the exclusion part can be reduced in diameter to be inserted from a trocar or a small incision when inserted into a body cavity.
  • a super elastic alloy or shape memory alloy for the frame, the exclusion part can be reduced in diameter to be inserted from a trocar or a small incision when inserted into a body cavity.
  • instruments having a function of restoring the original shape having a large exclusion area inside the body cavity Patent Documents 7 and 8).
  • a snake retractor that is flexible and allows manipulation of organ and tissue structures as a tool arm that is inserted through a lumen provided in an endoscope insertion tube.
  • Patent Document 9 This is also a multi-node type like the snake retractor inserted via the trocar, and has a complicated structure.
  • an object of the present invention is to provide a retractor that does not require an insertion path from the body surface in minimally invasive surgery such as laparoscopic surgery or NOTES. It is another object of the present invention to provide a method for eliminating a luminal organ and securing a surgical field within the abdominal cavity using a retractor that does not require an insertion path from the body surface.
  • Non-Patent Document 1 A gastric camera is used to raise the stomach wall from the luminal side and develop a technique for obtaining appropriate traction on the mesenchyme.
  • this method has a drawback in that the field of view of the endoscope is lost because the endoscope itself is used as a retractor.
  • the inventors raised the stomach wall from the stomach lumen side by deploying a retractor in the stomach via the treatment instrument channel of the flexible endoscope, not the flexible endoscope itself. As a result, it was found that appropriate traction to the intermesentery was obtained, and the present invention was completed. That is, the present invention is characterized in that the retraction required in the abdominal cavity is performed not from the outside of the organ but from the digestive tract lumen side.
  • the present invention provides a retractor including an exclusion portion having a blunt-shaped distal end, an introduction portion extending to the exclusion portion, and a handle portion provided at a proximal end of the introduction portion.
  • the exclusion part and the introduction part have an outer diameter that can be inserted into a treatment instrument channel of a flexible endoscope that is inserted into the lumen from a body surface opening of a hollow organ,
  • the exclusion portion expresses a predetermined shape when projected from the treatment instrument channel into the lumen, and has a smooth surface;
  • the introduction portion is made of a flexible material, and the handle portion is operable to change the shape of the exclusion portion.
  • the exclusion part is made of a shape memory material.
  • the shape memory material is a shape memory alloy.
  • the exclusion portion is surface-coated.
  • the exclusion part has a length of 15 to 20 cm.
  • the retractor can be used in surgery selected from the group consisting of laparoscopic surgery and NOTES.
  • the present invention also provides a method for excluding a luminal organ, the method comprising: Inserting a flexible endoscope having a treatment instrument channel into a lumen from a body surface opening of a luminal organ; Inserting a retractor into the treatment instrument channel, wherein the retractor is any of the above retractors; Projecting the retraction part of the retractor into the lumen of the luminal organ to express an arbitrary shape; and bringing the retraction part into contact with the inner wall of the luminal organ to relieve the inner wall.
  • the method is performed in a surgery selected from the group consisting of laparoscopic surgery and NOTES.
  • the present invention further provides a method for securing a surgical field in intraperitoneal or intraluminal surgery, Inserting a flexible endoscope having a treatment instrument channel into a lumen from a body surface opening of a luminal organ; Inserting a retractor into the treatment instrument channel, wherein the retractor is any of the above retractors; Allowing the retractor of the retractor to project into the lumen of the luminal organ to develop an arbitrary shape; and contacting the evacuation part with the inner wall of the luminal organ to squeeze the inner wall, A step of securing a surgical field in the abdominal cavity or in the lumen is included.
  • the intraperitoneal surgery is selected from the group consisting of laparoscopic surgery and NOTES.
  • the retractor of the present invention is inserted into the lumen of the luminal organ via the treatment instrument channel of the flexible endoscope, and quickly develops the shape designed in advance by the hand operation in the lumen. Due to the developed tip shape, the luminal organ can be evacuated / opened from the lumen side, and for example, a surgical operation in the abdominal cavity by NOTES can be assisted.
  • the surgical field can be secured without requiring an open passage from the body surface for excluding the organ other than the insertion path of the laparoscope. Further, since the exclusion operation can be performed while securing the visual field, for example, when there is a small lesion in the digestive tract cavity, the operation can be performed without damaging the lesion. Furthermore, there is no tissue pinching or damage caused by the instrument during use.
  • the retraction required in the abdominal cavity is performed not from the outside of the lumen organ but from the lumen side of the lumen organ by inserting the retractor into the lumen organ. be able to.
  • FIG. 1 It is a schematic diagram which shows one embodiment of the structure of the retractor of this invention. It is a partial schematic diagram which shows one embodiment at the time of exposing the retractor of this invention through the treatment tool channel of an endoscope. It is a schematic diagram which shows the various forms of the front-end
  • the retractor of the present invention is inserted into the stomach through the treatment instrument channel of the gastroscope, (a) a state in which the exclusion portion expressing the memory shape is pressed against the stomach wall, and (b) operation of the gastroscope
  • It is explanatory drawing which shows the state which raised the stomach wall from the lumen side by the exclusion part by each.
  • a retractor 1 is provided at an exclusion part 10 having a blunt-shaped distal end, an introduction part 20 extending to the exclusion part 10, and a proximal end of the introduction part 20.
  • the excluding portion 10 and the introducing portion 20 have an outer diameter that can be inserted into a treatment instrument channel of a flexible endoscope that is inserted into the lumen from a body surface opening of a hollow organ.
  • the exclusion part 10 is corresponded to the movable part in FIG.
  • the term “retractor” refers to an object that shifts the position of an object (for example, a luminal organ) in the medical field, or that excludes, opens, pulls, or lifts an object that obstructs the field of view. Medical equipment for securing and performing surgery.
  • the operations of exclusion, opening / extraction, traction, or elevation may be collectively referred to as “retraction” or “retraction”.
  • the term “exclusion” may include not only an exclusion operation but also an operation of opening, pulling, or raising (that is, retraction).
  • Target luminal organs include stomach, small intestine, large intestine, vagina and the like.
  • the retractor of the present invention is preferably used for the stomach, small intestine, and large intestine.
  • the flexible endoscope refers to a medical flexible endoscope.
  • a flexible endoscope uses a flexible material, and there are a built-in observation optical system using a glass fiber and a CCD using a CCD.
  • an illumination optical system is provided with a light source on the side of a control device outside the body, and the light is guided by an optical fiber and irradiated from the tip.
  • an LED is built in the endoscope tip.
  • an endoscope has a treatment instrument channel (sublumen) separate from these optical systems, and performs local cleaning, gas or liquid injection, drug spraying, suction, treatment by a dedicated device (gripping, Cutting, puncture, etc.).
  • the direction of the distal end of the endoscope can be freely changed by an operation at hand.
  • an endoscope having an appropriate size is selected according to a target lumen.
  • the exclusion part and the introduction part of the retractor of the present invention have an outer diameter that can be inserted into the treatment instrument channel of such a flexible endoscope.
  • the inner diameter of the treatment instrument channel is usually about 3 mm. Therefore, the outer diameter of the exclusion part and the introduction part of the retractor of the present invention can be less than 3 mm when inserted into the treatment instrument channel.
  • the retractor of the retractor of the present invention has a blunt-shaped distal end, and develops a predetermined shape when projected from the treatment instrument channel into the lumen.
  • the exclusion portion has a smooth surface so as not to damage the interior of the lumen.
  • distal refers to the part of the instrument furthest from the operator of the instrument
  • proximal refers to the part of the instrument that is closest to the operator
  • the retractor of the retractor according to the present invention has an outer diameter that can be inserted into the treatment instrument channel of the flexible endoscope, but can protrude from the treatment instrument channel into the lumen to express a predetermined shape.
  • Any structure may be used as long as it has a sufficient strength to eliminate the pressure.
  • a wire, tube, or rod-shaped configuration made of a shape memory material may be used. Or you may be comprised with the close_contact
  • it is preferably composed of a shape memory material.
  • the shape memory material is not particularly limited as long as it is a material having sufficient strength to exclude an organ with a predetermined shape, as long as it is not harmful to the living body.
  • the shape memory material is preferably a shape memory alloy, more preferably a shape memory alloy commonly used in medical devices.
  • shape memory alloys have been developed in various ways and are used in endoscopes, guide wires, catheters, stents, orthodontic wires, implant materials, osteosynthesis staples, and the like.
  • a nickel-titanium alloy typically nitinol
  • a copper-zinc-aluminum alloy, and the like can be given.
  • a shape memory alloy having a shape transformation temperature in the range of 32 ° C. to 40 ° C. is preferably used.
  • the shape expression is controlled by operating means provided together with these.
  • the operating means can be, for example, a wire.
  • the exclusion part is provided with a flexible mantle (for example, silicone rubber, polyurethane) that provides a smooth surface. .
  • the retraction part of the retractor of the present invention is composed of a plurality of segments, preferably, each tubular segment is connected, and an operating means for controlling the shape expression is provided in the cylinder. Also in this case, in order to prevent organ damage due to being sandwiched between the segments, the exclusion portion includes the above-described mantle.
  • the desired shape is not particularly limited as long as the desired shape can be eliminated in the target hollow organ.
  • it may be a fan type, a bent type, a loop type, a bar type, a curve type, or the like.
  • a bent shape in which one member is smoothly bent is particularly preferable. Examples of the bent shape include (a) triangle type, (b) circle type, and (c) angled triangle type shown in FIG.
  • Such an exclusion part has a length corresponding to the intended exclusion or shape, and has a length of 15 to 20 cm, for example.
  • the retractor of the retractor of the present invention has no joints or seams on the surface so as not to cause tissue pinching or damage by the instrument during use, in other words, it is not articulated or bellows type Is preferred.
  • the exclusion portion is formed of a contact coil, a mesh, or a plurality of segments, it is only necessary to include a flexible mantle that provides a smooth surface as described above.
  • an exclusion part is comprised from shape memory material
  • the shape is designed previously at the time of manufacture, and cannot be changed at the time of use. Accordingly, a retractor having various shapes, various lengths of movable parts, various bending angles, and the like should be provided according to the portion to be excluded and the exclusion range. There are a plurality of tip shapes depending on the part to be excluded and the exclusion range.
  • the retractor of the retractor of the present invention has a smooth surface so as not to damage the organ. Its distal end is dull (ie not sharp). Preferably, the vicinity of the distal end has a pigtail-like shape (ie, rounded) as shown in FIGS. The tip of the distal end is rounded and preferably spherical. Furthermore, the exclusion part may be surface-coated. For the coating, materials usually used for coating medical devices can be used. For example, the outer surface may be coated with a porous polytetrafluoroethylene (ePTFE) film, a silicone film, a polyurethane film, a polyethylene terephthalate (Dacron (registered trademark)) film, or the like.
  • ePTFE porous polytetrafluoroethylene
  • the retraction portion When constructed of shape memory material, the retraction portion becomes a flexible rod when inserted into the treatment instrument channel, and when exposed to the lumen from the treatment instrument channel, the retraction portion (eg, bent) The shape of the mold).
  • the shape In the treatment instrument channel, the shape is memorized so as to be formed into a straight rod shape physically by the lumen of the channel, or a straight rod shape at a temperature higher or lower than the shape transformation temperature.
  • the expression of the shape in the lumen can be performed at a temperature above or below the shape transformation temperature, or by being released from physical constraints.
  • the introduction part of the retractor of the present invention extends from the above-mentioned exclusion part, and connects the handle part and the exclusion part.
  • the length of the introduction part is sufficient if it is long enough to protrude (or be exposed) into the lumen targeted for the exclusion part, and is usually a wire extending to the treatment instrument for a flexible endoscope Can be equivalent to
  • the outer diameter of the introduction part is smaller than the inner diameter of the treatment instrument channel as described above, and is usually less than 3 mm.
  • the flexible material constituting the introduction portion of the retractor of the present invention allows the retraction portion to be delivered to the distal end of the endoscope via the treatment instrument channel and protruded (or exposed) into the lumen.
  • it may be a wire extending to a treatment instrument (for example, forceps) for a flexible endoscope.
  • the material includes a flexible material used for a stent or the like.
  • 316L stainless steel, tantalum, cobalt alloy, nitinol (nickel-titanium alloy), etc. which are medical stainless steels.
  • These wires may be, for example, coiled wires or wire meshes.
  • the introduction portion can move together in the treatment instrument channel in accordance with the movement of the flexible endoscope without interfering with the movement of the flexible endoscope.
  • the exclusion part can be further pushed out from the treatment instrument channel into the lumen through the introduction part, or the direction of the exclusion part can be changed in the lumen.
  • the introduction part may be provided with means for changing the shape of the exclusion part by operating the handle part as necessary.
  • a heat transfer means is additionally provided.
  • the heat transfer means include flexible heating wires that are insulated and heat-insulated.
  • the handle portion of the retractor of the present invention is provided at the proximal end of the introduction portion.
  • the exclusion part and the introduction part are inserted into the treatment instrument channel of the endoscope, and the exclusion part is delivered to the distal end of the endoscope and protruded (or exposed) into the lumen.
  • Can do for example, a structure may be adopted in which a dial is provided in the handle portion, and the dial is moved into or out of the treatment instrument channel by operating the dial (for example, rotating around the axis of the endoscope). .
  • This handle part can be operated to change the shape of the exclusion part.
  • the method of changing the shape of the exclusion portion is appropriately determined according to the configuration of the exclusion portion. For example, when the shape is expressed by the change in the shape transformation temperature of the shape memory alloy as described above, the heat transfer means is changed by the temperature adjusting means (for example, a heating device connected to the power source) provided in the handle portion. The shape of the exclusion part is changed by adjusting the exclusion part to a predetermined temperature.
  • the shape and structure of the handle part are not particularly limited as long as it has the above functions. It may be of a size and shape that is easy for the operator of the instrument to handle and is normally employed in the art.
  • the retractor of the present invention is inserted into a luminal organ from the treatment instrument channel of the flexible endoscope, and the exclusion part expresses a predetermined shape (for example, a memorized shape). While this exclusion part is monitored by an endoscope, the inner wall is pressed or pushed up by being brought into contact with the inner wall of the lumen by an operation with the handle part or an operation of the endoscope itself. By this operation, it is possible to realize the exclusion, opening, traction, or elevation required for the outer wall of the lumen in surgery or the like in the abdominal cavity. Appropriate traction can be obtained on the outer wall of the luminal organ, and a surgical field can be secured in the abdominal cavity. Alternatively, for example, by expanding the mucosal surface in the large intestine and expanding the fold, for example, by observing the entire polyp hidden in the fold, treatment with a normal endoscope becomes possible.
  • a predetermined shape for example, a memorized shape
  • the stomach endoscope 40 is orally inserted into the stomach S, and the retractor 1 of the present invention is inserted into the stomach S from the treatment instrument channel 42.
  • the exclusion part 10 is completely exposed in the stomach S to develop a memory shape (see FIG. 2 and FIG. 4A).
  • the exclusion portion 10 is brought into contact with the stomach wall and pressed against the stomach wall (FIG. 4 (a)).
  • the stomach wall is lifted from the inside by the exclusion unit 10 (FIG. 4B). A part of the stomach wall is raised in the abdominal cavity and tension is created between the stomach and the surroundings, making it easier to operate in the abdominal cavity. Therefore, by this operation, the stomach can be evacuated without incising the body surface.
  • the retractor of the present invention has been described mainly as a device for retracting the stomach wall from the lumen side, for example, when used in the colon cavity, it can also be applied to a colectomy.
  • An example of use in the colon cavity will be described with reference to FIGS. 5 and 6 by taking as an example the case of removing a polyp in the colon.
  • the retractor 1 of the present invention is inserted in the vicinity of the polyp P existing in the large intestine C through the treatment instrument channel of the large intestine endoscope 40 (FIG. 5).
  • the polyp P in the large intestine C is partially hidden by wrinkles on the large intestine wall when viewed from the large intestine endoscope 40 (FIG. 6A). Therefore, the retractor 1 of the present invention is disposed around the polyp P through the treatment instrument channel of the colonoscope 40 (FIG. 6B), and then the exclusion part of the retractor 1 that expresses the memory shape is defined as the polyp P.
  • the entire large polyp P By pressing against the surrounding large intestine wall, the entire large polyp P, in particular, the base portion thereof is crushed so that it can be seen (FIG. 6C). Since the surgical field can be secured in this way, the polyp P is reliably processed (for example, excised after ligating the whole blood vessel passing through the base) with the electric knife 50 inserted through the treatment instrument channel of the colonoscope 40. (FIG. 6D).
  • the retractor of the present invention is inserted into the lumen of a luminal organ via a treatment instrument channel of a flexible endoscope, and quickly develops a predesigned shape in the lumen.
  • the evacuation part having the expressed tip shape is used to evacuate and open the luminal organ from the lumen side, and for example, the surgical operation in the abdominal cavity by NOTES can be assisted.
  • the surgical field can be secured without requiring an open passage from the body surface for excluding the organ other than the insertion path of the laparoscope. Further, since the exclusion operation can be performed while securing the visual field, for example, when there is a small lesion in the digestive tract cavity, the operation can be performed without damaging the lesion. Furthermore, there is no tissue pinching or damage caused by the instrument during use.
  • the retractor of the present invention is a gastric resection, an esophagectomy, a small intestine resection, a splenectomy (expanding between the stomach and the spleen by expanding the stomach from the lumen) Etc.) and can be applied via a gastroscope.
  • Transgastric NOTES can be applied via an enteroscope in colectomy, rectal resection, small intestine resection, and the like. Alternatively, it can be applied to gynecology and urology.
  • the retractor of the present invention can be applied not only to NOTES but also to laparoscopic surgery, endoscopic surgery, or open surgery.
  • the gastrointestinal tract can be inserted into the lumen of the gastrointestinal tract via an endoscope and used. Such an operation eliminates the need for an organ repellent used under a laparoscope, thereby reducing the abdominal incision.
  • the retractor of the present invention can be used as an auxiliary when performing complex operations in a normal gastrointestinal endoscope (stomach camera or colon camera).
  • a polyp present on the back side of a coral that is difficult to access can be viewed from the front by deploying a wall using the retractor of the present invention, and can be excised endoscopically.

Abstract

Disclosed is a retractor (1) equipped with a retraction part (10) with a dull-shaped distal end, an introduction part (20) extending from the retraction part, and a handle (30) attached to the proximal end of the introduction part.  In this retractor, the retraction part and the introduction part each has an outer diameter allowing the insertion thereof into an instrument channel (42) of a flexible endoscope (40) that is to be inserted from the natural orifice of a hollow organ into the lumen.  When protruded from the instrument channel into the inside of the lumen, the retraction part changes the shape thereof into a definite shape and shows smooth surface.  The introduction part comprises a flexible material.  The handle can be manipulated so as to change the shape of the retraction part.  In a preferable embodiment, the retraction part comprises a shape-memory material.  Because of requiring no insertion pathway from the body surface, the aforesaid retractor is useful in minimally invasive surgical operations such as endoscopic surgeries and NOTES.

Description

軟性内視鏡用リトラクターFlexible endoscope retractor
 本発明は、内視鏡下外科手術において、施術対象臓器を適正視野に移動し、術野の妨げとなる臓器などを圧排・牽引して制御し、術中の視野(術野)を確保するための軟性内視鏡用リトラクターに関する。 The present invention, in an endoscopic surgical operation, moves an operation target organ to an appropriate visual field, and controls an organ that obstructs the surgical field by squeezing out and pulling to secure an intraoperative visual field (surgical field). The present invention relates to a retractor for a flexible endoscope.
 臨床各科においては、様々な病態に対する診断、治療効果の判定、治療方針の決定などを目的として体腔内の直接観察や処置が行われる。従来、これらは試験開腹あるいは試験開胸という侵襲の大きなアプローチで行われていた。しかし、近年の内視鏡下手術の普及に伴い、より切開創の小さな試験腹腔鏡や試験胸腔鏡で行われるようになってきた。 In clinical departments, direct observation and treatment of body cavities are performed for the purpose of diagnosis for various disease states, determination of therapeutic effects, determination of therapeutic strategies, and the like. Conventionally, these have been performed by a large invasive approach called test laparotomy or test thoracotomy. However, with the spread of endoscopic surgery in recent years, it has come to be performed with a test laparoscope or a test thoracoscope with a smaller incision.
 例えば、特許文献1および2には、小さな直径で皮膚を貫通して体腔まで挿入した後に、貫通腔を容易に拡張して、さらに大きい直径の外科器具を通す通路を提供することができるトロカールシステムが開示されている。このシステムによれば、従来のように外科器具の直径に応じた大きな切開を施した場合と比較して、患者の外傷が小さく、回復にかかる時間は非常に短くなる。 For example, Patent Documents 1 and 2 describe a trocar system that can provide a passage through which a larger diameter surgical instrument can be easily expanded after penetrating the skin with a small diameter and inserting it into a body cavity. Is disclosed. According to this system, compared with the conventional case where a large incision corresponding to the diameter of the surgical instrument is made, the trauma of the patient is small, and the recovery time is very short.
 一方、患者の外傷を最小限に抑えるための低侵襲性の新たな技術が開発されている。この技術は、Natural Orifice Translumenal Endoscopic Surgery(NOTES:体表無切開内視鏡手術)として知られており、管腔臓器の体表開口部(natural orifice:口、肛門、膣など)から管腔内へ軟性内視鏡を挿入し、管腔臓器の壁を切開して体腔内へ到達し、診断・処置・治療を行うという全く新しい技術である。理論的には、体表の切開創を一切必要としないため(incisionless)、内視鏡下手術を上回る低侵襲性が期待される。海外では、腹腔鏡補助下の経腟的あるいは経胃的「部分的NOTES」の臨床成功例も報告され、大きな関心を集めている。近い将来には腹腔鏡の補助を要さない、軟性内視鏡のみによる「完全NOTES」の臨床導入も期待されている。 Meanwhile, new minimally invasive techniques have been developed to minimize patient trauma. This technique, known as Natural Orifice Translumenal Endoscopic Surgery (NOTES), is performed through the body surface opening of a luminal organ (natural orifice: mouth, anus, vagina, etc.) This is a completely new technique in which a flexible endoscope is inserted, a wall of a luminal organ is incised to reach a body cavity, and diagnosis, treatment, and treatment are performed. Theoretically, since no incision on the surface of the body is required (incisionless), it is expected to be less invasive than endoscopic surgery. Overseas, cases of clinical success of laparoscopic-assisted transvaginal or transgastric “partial NOTES” have been reported and are attracting great interest. In the near future, clinical introduction of “complete NOTES” using only a flexible endoscope, which does not require laparoscopic assistance, is also expected.
 このような内視鏡下手術では、開腹手術と比較して、手術空間に制約があること、あるいは自在に視野の方向が変えられないことなどにより、最適視野を確保するのが難しいという欠点がある。この問題点が内視鏡下手術を困難なものとする一因となっている。例えば、経腟NOTES胃手術においては、いかに胃壁を挙上させて、胃周囲の安定した術野展開を得るかが、技術的課題の1つである。胃の切除術においては、例えば、ステープラーによる胃切除に先立って胃周囲の間膜を広く切離し、胃を十分に授動しておく必要がある。この際、切離すべき間膜には適度な緊張(またはトラクション)を与えることが必要であるため、軟性内視鏡に設けられた1.2mm~3.0mmのチャンネルを通して処置具を挿入し、間膜を把持・牽引するという操作が行われる。しかし、現状では、腹腔鏡用鉗子による補助が行われており、そのため、完全NOTESではなく部分的NOTESしかできない。 In such endoscopic surgery, there is a drawback that it is difficult to secure an optimum visual field compared to open surgery, because the surgical space is limited or the direction of the visual field cannot be freely changed. is there. This problem contributes to the difficulty of endoscopic surgery. For example, in vaginal NOTES gastric surgery, how to raise the stomach wall and obtain a stable surgical field around the stomach is one of the technical problems. In gastrectomy, for example, prior to gastrectomy with a stapler, it is necessary to widely dissect the mesenchyme around the stomach and to fully activate the stomach. At this time, since it is necessary to give moderate tension (or traction) to the mesenchyme to be separated, the treatment instrument is inserted through a channel of 1.2 mm to 3.0 mm provided in the flexible endoscope, The operation of grasping and pulling the mesenchyme is performed. However, at present, assistance with laparoscopic forceps is performed, and therefore, only partial NOTES can be performed instead of complete NOTES.
 術中の視野(術野)の問題を緩和するために、種々のリトラクターが開発されている。リトラクターとは、手術対象組織の位置を適正な術野内に移動させたり、術野を妨げる組織を圧排あるいは牽引したりして、術野を確保するために主に用いられる器具である。リトラクターには、基本的な機能として、これを体内へ挿入する際、挿入通路となるトロッカー(外套管)または小切開創のような小さな開口通路より器具が挿通できることが求められている。したがって、少なくとも挿入時は細径であり(例えば、トロッカーの場合10mm以下、小切開創の場合20mm以下が望ましい)かつ棒状の形態であることが必要であり、一方、体腔内挿入後は、対象物を幅広く安全に圧排するために、圧排部がある程度大きな面積を有する形状に変形可能であることが要求される。 Various retractors have been developed to alleviate the problem of intraoperative visual field (operating field). A retractor is an instrument mainly used to secure a surgical field by moving the position of a tissue to be operated into an appropriate surgical field or by excluding or pulling a tissue that obstructs the surgical field. As a basic function, the retractor is required to be able to insert a device through a small opening passage such as a trocar (outer tube) or a small incision as an insertion passage when the retractor is inserted into the body. Therefore, it is necessary to have a small diameter at least at the time of insertion (for example, 10 mm or less for a trocar, and preferably 20 mm or less for a small incision) and a rod-like form. In order to exclude objects widely and safely, it is required that the excluding portion be deformable into a shape having a certain large area.
 上述の相反する要求に応じて、種々に工夫されたリトラクターが提案あるいは市販されている。例えば、圧排部が扇状に拡開するものがある(例えば、特許文献3)。これは、トロッカーの腹腔への挿入時には、扇状圧排部が畳まれて棒状管の内部に収納されており、体腔内で棒状管より押し出されて扇状に広がるものである。扇状圧排部を任意の大きさまで手元操作により拡げる構造のものや、圧排部と基部との角度が可変するものなどがあり、比較的幅広く臓器を圧排できる利点があることから肝臓や腸を圧排するのに好適となっている。なお、形状は扇型に限らず、菱形などの種々の形状のものが多数提案されている。 In response to the above conflicting requirements, various retractors have been proposed or marketed. For example, there is one in which the exclusion portion expands in a fan shape (for example, Patent Document 3). When the trocar is inserted into the abdominal cavity, the fan-shaped exclusion portion is folded and stored in the rod-shaped tube, and is pushed out from the rod-shaped tube in the body cavity and spreads in a fan shape. There are structures that can expand the fan-shaped exclusion part to an arbitrary size by hand operation, and those that can change the angle between the exclusion part and the base, etc. It is suitable for. Note that the shape is not limited to a fan shape, and many shapes having various shapes such as rhombus have been proposed.
 これとは別のタイプとして、圧排部の棒状体が体腔内で屈曲するスネーク式リトラクターがある(例えば、特許文献4および5)。トロッカー挿入時は、屈曲した圧排部が直線状に棒状管内部に収納されており、体腔内で棒状管より押し出すと屈曲形状に戻るもの、あるいは挿入時には棒状のものを、体腔内で種々の形状に屈曲させ、該屈曲形状を固定することのできるものがある。これらは、対象物を屈曲部で挟み込むように牽引するのに特に有効であり、腹腔鏡下手術において広く普及している。 As another type, there is a snake retractor in which the rod-like body of the exclusion part bends in the body cavity (for example, Patent Documents 4 and 5). When the trocar is inserted, the bent extruding part is linearly housed inside the rod-shaped tube, and when it is pushed out from the rod-shaped tube in the body cavity, it returns to the bent shape, or when inserted, the rod-shaped one has various shapes in the body cavity. Can be bent and the bent shape can be fixed. These are particularly effective for pulling an object so as to be sandwiched between bent portions, and are widely used in laparoscopic surgery.
 あるいは、先端部がループ形状のものもある(例えば、特許文献6)。これは、管の先端から細径のループを出し、該ループで組織を締めて把持牽引するタイプである。細径のトロッカーからの挿入が可能で極めて低侵襲性であるが、圧排には適応できない。一方、体内臓器などを圧排および牽引するリトラクターとして、ゴム弾性薄膜の面状シートおよび該面状シートの辺縁周囲を固着してほぼ囲繞するフレームとによりなる圧排部と、該圧排部に延設される把持部とから構成され、該フレームに超弾性合金または形状記憶合金を用いることにより、圧排部が、体腔内挿入時にはトロッカーあるいは小切開創より挿入可能な径に細径化可能であり、かつ体腔内部では広い圧排面積を有する元の形状へ復元する機能を有する器具もある(特許文献7および8)。 Alternatively, there is a tip portion having a loop shape (for example, Patent Document 6). This is a type in which a small-diameter loop is taken out from the distal end of the tube, and the tissue is clamped and pulled by the loop. Although it can be inserted from a small-sized trocar and is extremely minimally invasive, it cannot be adapted to exclusion. On the other hand, as a retractor for evacuating and pulling internal organs and the like, an evacuation portion comprising a sheet of rubber elastic thin film and a frame that substantially surrounds and surrounds the periphery of the sheet is extended to the evacuation portion. By using a super elastic alloy or shape memory alloy for the frame, the exclusion part can be reduced in diameter to be inserted from a trocar or a small incision when inserted into a body cavity. There are also instruments having a function of restoring the original shape having a large exclusion area inside the body cavity (Patent Documents 7 and 8).
 また、内視鏡挿入用のチューブに備えられた管腔を通じて挿入されるツールアームとして、可撓性でありかつ器官および組織の構造の操作を可能にするようなスネーク式リトラクターが開示されている(特許文献9)。これも、上記のトロッカー経由で挿入されるスネーク式リトラクターと同様に多節型のものであり、複雑な構造を有する。 Also disclosed is a snake retractor that is flexible and allows manipulation of organ and tissue structures as a tool arm that is inserted through a lumen provided in an endoscope insertion tube. (Patent Document 9). This is also a multi-node type like the snake retractor inserted via the trocar, and has a complicated structure.
 これらはいずれも、体表の切開部より体腔内へあるいは管腔臓器の体表開口部から臓器内部に挿入され、その挿入された腔内で内視鏡の観察下にて臓器を圧排するものである。 All of these are inserted into the body cavity through the incision on the body surface or from the body surface opening of the hollow organ, and the organ is evacuated under the observation of the endoscope in the inserted cavity. It is.
米国特許第5320611号明細書US Pat. No. 5,320,611 特表平8-507238号公報JP-T 8-507238 特開平6-154152号公報JP-A-6-154152 特表平7-502914号公報JP 7-502914 A 米国特許出願公開第2002/011536号明細書US Patent Application Publication No. 2002/011536 特開2000-23989号公報JP 2000-23989 A 特開2003-164459号公報JP 2003-16459 A 特開2005-237398号公報JP 2005-237398 A 特表2007-511247号公報Special table 2007-511247 gazette
 上述のように、現在の腹腔鏡下手術においては、腹腔鏡の挿入経路以外にも、臓器を圧排するための体表からの開口通路が必要である。また、NOTES研究者の間では、臓器の挙上や圧排を容易にするためのデバイスの必要性は未だ広く認識されていない。そこで、本発明は、腹腔鏡下手術やNOTESなどの低侵襲性の手術において、体表からの挿入経路を必要としないリトラクターを提供することを目的とする。さらに、体表からの挿入経路を必要としないリトラクターを用いて、管腔臓器を圧排し、腹腔内での術野を確保する方法を提供することも目的とする。 As described above, in the current laparoscopic surgery, in addition to the insertion path of the laparoscope, an open passage from the body surface for excluding the organ is necessary. Moreover, the necessity of a device for facilitating organ elevation and exclusion has not been widely recognized among NOTES researchers. Therefore, an object of the present invention is to provide a retractor that does not require an insertion path from the body surface in minimally invasive surgery such as laparoscopic surgery or NOTES. It is another object of the present invention to provide a method for eliminating a luminal organ and securing a surgical field within the abdominal cavity using a retractor that does not require an insertion path from the body surface.
 本発明者らは、ブタにおいて経腟NOTESによる胃の切除を行う際に、経腟的に腹腔内に挿入された軟性内視鏡とは別に、胃内へ挿入した別の軟性内視鏡(胃カメラ)を用いて、管腔側から胃壁を挙上し、間膜に適切なトラクションを得る手法を開発している(非特許文献1)。しかし、この方法では、内視鏡そのものをリトラクターとして使用するため、内視鏡の視野が失われるという欠点がある。視野を確保するために、先端に透明なキャップまたはフードを装着した内視鏡を用いて胃壁を挙上することも可能であるが、この場合も視野は制限される。 The present inventors, when performing resection of the stomach with transvaginal NOTES in pigs, separate from the flexible endoscope inserted into the abdominal cavity transvaginally, another flexible endoscope inserted into the stomach ( A gastric camera is used to raise the stomach wall from the luminal side and develop a technique for obtaining appropriate traction on the mesenchyme (Non-Patent Document 1). However, this method has a drawback in that the field of view of the endoscope is lost because the endoscope itself is used as a retractor. In order to secure a visual field, it is possible to raise the stomach wall using an endoscope with a transparent cap or hood attached to the tip, but this also restricts the visual field.
 そこで、発明者らは、軟性内視鏡そのものではなく、軟性内視鏡の処置具チャンネル経由で圧排子(リトラクター)を胃内で展開することにより、胃内腔側から胃壁を挙上させて周囲間膜への適切なトラクションが得られることを見出し、本発明を完成した。すなわち、本発明は、腹腔内で必要とされているリトラクションを、臓器の外側からではなく、消化管内腔側から行うということを特徴とする。 Therefore, the inventors raised the stomach wall from the stomach lumen side by deploying a retractor in the stomach via the treatment instrument channel of the flexible endoscope, not the flexible endoscope itself. As a result, it was found that appropriate traction to the intermesentery was obtained, and the present invention was completed. That is, the present invention is characterized in that the retraction required in the abdominal cavity is performed not from the outside of the organ but from the digestive tract lumen side.
 本発明は、鈍い形状の遠位端を有する圧排部、該圧排部に延設される導入部、および該導入部の近位端に設けられたハンドル部を備えるリトラクターを提供し、該リトラクターにおいて、
 該圧排部および該導入部は、管腔臓器の体表開口部から該管腔内へ挿入される軟性内視鏡の処置具チャンネルに挿入可能な外径を有し、
 該圧排部は、該処置具チャンネルから該管腔内部に突出されると所定の形状を発現し、そして平滑な表面を有し、
 該導入部は、可撓性材料から構成され、そして
 該ハンドル部は、該圧排部の形状を変化させるように操作可能である。
The present invention provides a retractor including an exclusion portion having a blunt-shaped distal end, an introduction portion extending to the exclusion portion, and a handle portion provided at a proximal end of the introduction portion. In the tractor,
The exclusion part and the introduction part have an outer diameter that can be inserted into a treatment instrument channel of a flexible endoscope that is inserted into the lumen from a body surface opening of a hollow organ,
The exclusion portion expresses a predetermined shape when projected from the treatment instrument channel into the lumen, and has a smooth surface;
The introduction portion is made of a flexible material, and the handle portion is operable to change the shape of the exclusion portion.
 1つの実施態様では、上記圧排部は、形状記憶材料から構成される。 In one embodiment, the exclusion part is made of a shape memory material.
 1つの実施態様では、上記形状記憶材料は、形状記憶合金である。 In one embodiment, the shape memory material is a shape memory alloy.
 1つの実施態様では、上記圧排部は、表面コーティングされている。 In one embodiment, the exclusion portion is surface-coated.
 1つの実施態様では、上記圧排部は、15~20cmの長さを有する。 In one embodiment, the exclusion part has a length of 15 to 20 cm.
 1つの実施態様では、上記リトラクターは、腹腔鏡下手術およびNOTESからなる群より選択される手術において使用可能である。 In one embodiment, the retractor can be used in surgery selected from the group consisting of laparoscopic surgery and NOTES.
 本発明はまた、管腔臓器の圧排方法を提供し、該方法は、
 処置具チャンネルを備える軟性内視鏡を、管腔臓器の体表開口部から該管腔内へ挿入する工程;
 リトラクターを、該処置具チャンネルに挿入する工程であって、該リトラクターが、上記いずれかのリトラクターである、工程;
 該リトラクターの圧排部を該管腔臓器の内腔へ突出させて、任意の形状を発現させる工程;および
 該圧排部を該管腔臓器の内壁に接触させて、該内壁を圧排する工程
を包含する。
The present invention also provides a method for excluding a luminal organ, the method comprising:
Inserting a flexible endoscope having a treatment instrument channel into a lumen from a body surface opening of a luminal organ;
Inserting a retractor into the treatment instrument channel, wherein the retractor is any of the above retractors;
Projecting the retraction part of the retractor into the lumen of the luminal organ to express an arbitrary shape; and bringing the retraction part into contact with the inner wall of the luminal organ to relieve the inner wall. Include.
 1つの実施態様では、上記方法は、腹腔鏡下手術およびNOTESからなる群より選択される手術において行われる。 In one embodiment, the method is performed in a surgery selected from the group consisting of laparoscopic surgery and NOTES.
 本発明はさらに、腹腔内手術または管腔内手術において術野を確保する方法を提供し、該方法は、
 処置具チャンネルを備える軟性内視鏡を、管腔臓器の体表開口部から該管腔内へ挿入する工程;
 リトラクターを、該処置具チャンネルに挿入する工程であって、該リトラクターが、上記いずれかのリトラクターである、工程;
 該リトラクターの圧排部を該管腔臓器の内腔へ突出させて、任意の形状を発現させる工程;および
 該圧排部を該管腔臓器の内壁に接触させて、該内壁を圧排し、該腹腔内または該管腔内での術野を確保する工程
を包含する。
The present invention further provides a method for securing a surgical field in intraperitoneal or intraluminal surgery,
Inserting a flexible endoscope having a treatment instrument channel into a lumen from a body surface opening of a luminal organ;
Inserting a retractor into the treatment instrument channel, wherein the retractor is any of the above retractors;
Allowing the retractor of the retractor to project into the lumen of the luminal organ to develop an arbitrary shape; and contacting the evacuation part with the inner wall of the luminal organ to squeeze the inner wall, A step of securing a surgical field in the abdominal cavity or in the lumen is included.
 1つの実施態様では、上記腹腔内手術は、腹腔鏡下手術およびNOTESからなる群より選択される。 In one embodiment, the intraperitoneal surgery is selected from the group consisting of laparoscopic surgery and NOTES.
 本発明のリトラクターは、軟性内視鏡の処置具チャンネルを経由して管腔臓器の内腔へ挿入され、手元操作によって予め設計された形状を内腔で速やかに発現する。その発現した先端形状により、管腔臓器を内腔側から圧排・開排し、例えば、NOTESによる腹腔での手術操作を補助できる。 The retractor of the present invention is inserted into the lumen of the luminal organ via the treatment instrument channel of the flexible endoscope, and quickly develops the shape designed in advance by the hand operation in the lumen. Due to the developed tip shape, the luminal organ can be evacuated / opened from the lumen side, and for example, a surgical operation in the abdominal cavity by NOTES can be assisted.
 本発明のリトラクターを用いれば、腹腔鏡の挿入経路以外に臓器を圧排するための体表からの開口通路を必要とすることなく、術野を確保することができる。また、視野を確保しながら圧排操作を行うことが可能であるため、例えば、消化管腔に小さな病変がある場合、その病変を損傷することなく操作することが可能である。さらに、使用中に器具による組織の挟み込みや損傷を生じることもない。 Using the retractor of the present invention, the surgical field can be secured without requiring an open passage from the body surface for excluding the organ other than the insertion path of the laparoscope. Further, since the exclusion operation can be performed while securing the visual field, for example, when there is a small lesion in the digestive tract cavity, the operation can be performed without damaging the lesion. Furthermore, there is no tissue pinching or damage caused by the instrument during use.
 本発明の方法によれば、リトラクターを管腔臓器に挿入することにより、腹腔内で必要とされているリトラクションを、管腔臓器の外側からではなく、管腔臓器の内腔側から行うことができる。 According to the method of the present invention, the retraction required in the abdominal cavity is performed not from the outside of the lumen organ but from the lumen side of the lumen organ by inserting the retractor into the lumen organ. be able to.
本発明のリトラクターの構造の一実施態様を示す模式図である。It is a schematic diagram which shows one embodiment of the structure of the retractor of this invention. 本発明のリトラクターを内視鏡の処置具チャンネルを通して露出させた場合の一実施態様を示す、部分模式図である。It is a partial schematic diagram which shows one embodiment at the time of exposing the retractor of this invention through the treatment tool channel of an endoscope. 本発明のリトラクターの先端部の種々の形態を示す模式図であり、それぞれ(a)トライアングル型、(b)サークル型、および(c)角度付トライアングル型を示す。It is a schematic diagram which shows the various forms of the front-end | tip part of the retractor of this invention, (a) Triangle type | mold, (b) Circle type, and (c) Angled triangle type | mold, respectively. 本発明のリトラクターを胃内視鏡の処置具チャンネルを通して胃内に挿入し、(a)記憶形状を発現させた圧排部を胃壁に押し当てた状態、および(b)胃内視鏡の操作によって圧排部で胃壁を内腔側から挙上した状態をそれぞれ示す、説明図である。The retractor of the present invention is inserted into the stomach through the treatment instrument channel of the gastroscope, (a) a state in which the exclusion portion expressing the memory shape is pressed against the stomach wall, and (b) operation of the gastroscope It is explanatory drawing which shows the state which raised the stomach wall from the lumen side by the exclusion part by each. 本発明のリトラクターを大腸内視鏡の処置具チャンネルを通して大腸内に挿入した状態を示す、模式図である。It is a schematic diagram which shows the state which inserted the retractor of this invention in the large intestine through the treatment tool channel of the large intestine endoscope. 本発明のリトラクターを大腸内視鏡の処置具チャンネルを通して大腸内に挿入した場合の説明図であり、(a)大腸内視鏡から大腸内のポリープを見た場合に、ポリープの基部が大腸壁の襞により部分的に隠れている状態、(b)本発明のリトラクターを大腸内視鏡の処置具チャンネルを通して大腸内のポリープ付近に配置した状態、(c)記憶形状を発現させたリトラクターの圧排部をポリープ周囲の大腸壁に押し当てて襞を圧排し、ポリープ全体、特に基部を見えるようにした状態、および(d)大腸内視鏡の処置具チャンネルを通して挿入した電気メスによってポリープの基部を処理する状態をそれぞれ示す。It is explanatory drawing at the time of inserting the retractor of this invention into the large intestine through the treatment tool channel of a large intestine endoscope, (a) When the polyp in the large intestine is seen from the large intestine endoscope, the base of the polyp is the large intestine A state in which it is partially hidden by a wall fold, (b) a state in which the retractor of the present invention is disposed near a polyp in the large intestine through the treatment instrument channel of the large intestine endoscope, The tractor's retraction part is pressed against the colon wall around the polyp to relieve the sputum, and the entire polyp, especially the base, is visible, and (d) a polyp with an electric knife inserted through the treatment instrument channel of the large intestine endoscope The state of processing the base of each is shown.
 図1を参照すると、本発明のリトラクター1は、鈍い形状の遠位端を有する圧排部10、該圧排部10に延設される導入部20、および該導入部20の近位端に設けられたハンドル部30を備え、該圧排部10および該導入部20は、管腔臓器の体表開口部から該管腔内へ挿入される軟性内視鏡の処置具チャンネルに挿入可能な外径を有する。圧排部10は、図1における可動部分に相当する。 Referring to FIG. 1, a retractor 1 according to the present invention is provided at an exclusion part 10 having a blunt-shaped distal end, an introduction part 20 extending to the exclusion part 10, and a proximal end of the introduction part 20. The excluding portion 10 and the introducing portion 20 have an outer diameter that can be inserted into a treatment instrument channel of a flexible endoscope that is inserted into the lumen from a body surface opening of a hollow organ. Have The exclusion part 10 is corresponded to the movable part in FIG.
 本明細書において、用語「リトラクター」とは、医療分野において対象物(例えば、管腔臓器)の位置をずらし、あるいは視野を妨げるものを圧排、開排、牽引、または挙上し、視野を確保して手術を行うための医療器具をいう。また、圧排、開排、牽引、または挙上の操作をまとめて「リトラクション」または「リトラクト」という場合がある。なお、本明細書において、単に「圧排」という場合は、圧排の操作のみでなく、開排、牽引、または挙上する操作を包含する(すなわち、リトラクションを意味する)場合がある。 In the present specification, the term “retractor” refers to an object that shifts the position of an object (for example, a luminal organ) in the medical field, or that excludes, opens, pulls, or lifts an object that obstructs the field of view. Medical equipment for securing and performing surgery. In addition, the operations of exclusion, opening / extraction, traction, or elevation may be collectively referred to as “retraction” or “retraction”. In the present specification, the term “exclusion” may include not only an exclusion operation but also an operation of opening, pulling, or raising (that is, retraction).
 対象となる管腔臓器としては、胃、小腸、大腸、膣などが挙げられる。本発明のリトラクターは、好ましくは、胃、小腸、および大腸に対して用いられる。 Target luminal organs include stomach, small intestine, large intestine, vagina and the like. The retractor of the present invention is preferably used for the stomach, small intestine, and large intestine.
 本明細書において、軟性内視鏡とは、医療用の軟性内視鏡をいう。このような軟性内視鏡は、柔軟な素材を用いており、内蔵される観察光学系として、グラスファイバーを用いたものと、CCDを用いたものとがある。また、照明光学系として体外の制御装置側に光源を備え、光ファイバーで光を導いて先端部から照射するものが一般的である。また、LEDを内視鏡先端に内蔵したタイプもある。内視鏡は、一般的に、これらの光学系とは別の処置具チャンネル(サブルーメン)を有し、局所の洗浄、気体や液体の注入、薬剤散布、吸引、専用デバイスによる処置(把持、切断・穿刺など)などが可能である。また、手元の操作で内視鏡の先端の向きを自在に変更可能であり得る。軟性内視鏡は、目的の管腔に応じて適切なサイズの内視鏡が選択される。本発明のリトラクターの圧排部および導入部は、このような軟性内視鏡の処置具チャンネルに挿入可能な外径を有している。処置具チャンネルの内径は、通常約3mmである。したがって、本発明のリトラクターの圧排部および導入部は、処置具チャンネルに挿入される際には、その外径が3mm未満であり得る。 In this specification, the flexible endoscope refers to a medical flexible endoscope. Such a flexible endoscope uses a flexible material, and there are a built-in observation optical system using a glass fiber and a CCD using a CCD. In general, an illumination optical system is provided with a light source on the side of a control device outside the body, and the light is guided by an optical fiber and irradiated from the tip. There is also a type in which an LED is built in the endoscope tip. In general, an endoscope has a treatment instrument channel (sublumen) separate from these optical systems, and performs local cleaning, gas or liquid injection, drug spraying, suction, treatment by a dedicated device (gripping, Cutting, puncture, etc.). In addition, the direction of the distal end of the endoscope can be freely changed by an operation at hand. As the flexible endoscope, an endoscope having an appropriate size is selected according to a target lumen. The exclusion part and the introduction part of the retractor of the present invention have an outer diameter that can be inserted into the treatment instrument channel of such a flexible endoscope. The inner diameter of the treatment instrument channel is usually about 3 mm. Therefore, the outer diameter of the exclusion part and the introduction part of the retractor of the present invention can be less than 3 mm when inserted into the treatment instrument channel.
 本発明のリトラクターの圧排部は、鈍い形状の遠位端を有し、そして処置具チャンネルから管腔内部に突出されると所定の形状を発現する。発現された形状において、圧排部は、管腔内部を傷つけないように、平滑な表面を有する。 The retractor of the retractor of the present invention has a blunt-shaped distal end, and develops a predetermined shape when projected from the treatment instrument channel into the lumen. In the expressed shape, the exclusion portion has a smooth surface so as not to damage the interior of the lumen.
 本明細書において、用語「遠位」は、器具の操作者から最も遠い器具の部分をいい、そして用語「近位」は、操作者に最も近い器具の部分をいう。 As used herein, the term “distal” refers to the part of the instrument furthest from the operator of the instrument, and the term “proximal” refers to the part of the instrument that is closest to the operator.
 本発明のリトラクターの圧排部は、軟性内視鏡の処置具チャンネルに挿入可能な外径を有するが、処置具チャンネルから管腔内部に突出されて所定の形状を発現でき、その形状により臓器を圧排するに十分な強度を有する限り、どのような構成であってもよい。例えば、形状記憶材料からなるワイヤー、チューブ、またはロッド状の構成であってもよい。あるいは、密着コイルやメッシュで構成されていてもよく、複数のセグメントが連続した構成であってもよい。本発明においては、形状記憶材料から構成されることが好ましい。 The retractor of the retractor according to the present invention has an outer diameter that can be inserted into the treatment instrument channel of the flexible endoscope, but can protrude from the treatment instrument channel into the lumen to express a predetermined shape. Any structure may be used as long as it has a sufficient strength to eliminate the pressure. For example, a wire, tube, or rod-shaped configuration made of a shape memory material may be used. Or you may be comprised with the close_contact | adherence coil and the mesh, and the structure with which the several segment continued may be sufficient. In the present invention, it is preferably composed of a shape memory material.
 本発明のリトラクターの圧排部が形状記憶材料で構成される場合、形状記憶材料は、所定の形状により臓器を圧排するに十分な強度を有する材料であれば、生体に有害でない限り、特に限定されない。形状記憶材料は、好ましくは形状記憶合金であり、より好ましくは医療器具に通常用いられる形状記憶合金である。このような形状記憶合金は、種々開発されており、内視鏡、ガイドワイヤー、カテーテル、ステント、歯科矯正用ワイヤー、インプラント材、骨接合用ステープルなどに用いられている。例えば、ニッケル-チタン系合金(代表的には、ナイチノール)、銅-亜鉛-アルミニウム系合金などが挙げられる。例えば、形状変態温度が32℃~40℃の範囲の形状記憶合金が好適に用いられる。 When the exclusion part of the retractor of the present invention is made of a shape memory material, the shape memory material is not particularly limited as long as it is a material having sufficient strength to exclude an organ with a predetermined shape, as long as it is not harmful to the living body. Not. The shape memory material is preferably a shape memory alloy, more preferably a shape memory alloy commonly used in medical devices. Such shape memory alloys have been developed in various ways and are used in endoscopes, guide wires, catheters, stents, orthodontic wires, implant materials, osteosynthesis staples, and the like. For example, a nickel-titanium alloy (typically nitinol), a copper-zinc-aluminum alloy, and the like can be given. For example, a shape memory alloy having a shape transformation temperature in the range of 32 ° C. to 40 ° C. is preferably used.
 本発明のリトラクターの圧排部が密着コイルやメッシュで構成される場合、形状発現は、これらにとともに備えられた操作手段でコントロールされる。操作手段は、例えば、ワイヤーであり得る。また、形状発現時にコイル間の間隙やメッシュ間に臓器が挟み込まれる可能性を排除するために、圧排部は、平滑な表面を提供する可撓性の外套(例えば、シリコーンゴム、ポリウレタン)を備える。 When the retraction part of the retractor of the present invention is constituted by a contact coil or a mesh, the shape expression is controlled by operating means provided together with these. The operating means can be, for example, a wire. Further, in order to eliminate the possibility of organs being sandwiched between the gaps between the coils and the mesh at the time of shape development, the exclusion part is provided with a flexible mantle (for example, silicone rubber, polyurethane) that provides a smooth surface. .
 本発明のリトラクターの圧排部が複数のセグメントで構成される場合、好適には、各筒状のセグメントが連結しており、筒内には形状発現をコントロールするための操作手段が備えられる。この場合も、セグメント間に挟み込まれることによる臓器損傷を防止するために、圧排部は、上記のような外套を備える。 When the retraction part of the retractor of the present invention is composed of a plurality of segments, preferably, each tubular segment is connected, and an operating means for controlling the shape expression is provided in the cylinder. Also in this case, in order to prevent organ damage due to being sandwiched between the segments, the exclusion portion includes the above-described mantle.
 図2を参照すると、本発明のリトラクター1の圧排部10は、内視鏡40の処置具チャンネル42から管腔内部に突出されると所定の形状を発現する。所望の形状は、対象とする管腔臓器において目的の圧排を行うことが可能な形状であれば、特に限定されない。例えば、扇型、屈曲型、ループ型、バー型、カーブ型などであり得る。本発明のリトラクターにおいては、1つの部材が滑らかに屈曲した屈曲型の形状が特に好ましい。屈曲型の形状としては、図3に示す(a)トライアングル型、(b)サークル型、(c)角度付トライアングル型などが挙げられる。このような圧排部は、目的の圧排や形状に応じた長さを有し、例えば、15~20cmの長さを有する。 Referring to FIG. 2, when the retractor 10 of the retractor 1 of the present invention protrudes from the treatment instrument channel 42 of the endoscope 40 into the lumen, a predetermined shape is developed. The desired shape is not particularly limited as long as the desired shape can be eliminated in the target hollow organ. For example, it may be a fan type, a bent type, a loop type, a bar type, a curve type, or the like. In the retractor of the present invention, a bent shape in which one member is smoothly bent is particularly preferable. Examples of the bent shape include (a) triangle type, (b) circle type, and (c) angled triangle type shown in FIG. Such an exclusion part has a length corresponding to the intended exclusion or shape, and has a length of 15 to 20 cm, for example.
 また、本発明のリトラクターの圧排部には、使用中に器具による組織の挟み込みや損傷を生じないように、関節または継ぎ目が表面に存在しないこと、言い換えれば、多関節型や蛇腹式でないことが好ましい。しかし、圧排部が密着コイルやメッシュあるいは複数のセグメントで構成される場合には、上述のように、平滑な表面を提供する可撓性の外套を備えていればよい。 Also, the retractor of the retractor of the present invention has no joints or seams on the surface so as not to cause tissue pinching or damage by the instrument during use, in other words, it is not articulated or bellows type Is preferred. However, in the case where the exclusion portion is formed of a contact coil, a mesh, or a plurality of segments, it is only necessary to include a flexible mantle that provides a smooth surface as described above.
 なお、圧排部は、形状記憶材料から構成される場合、その形状が製造時に予め設計され、使用時に変更することはできない。したがって、圧排すべき部位や圧排範囲に応じて、種々の形状、種々の可動部分の長さ、種々の屈曲の角度など有するリトラクターが提供されるべきである。先端の形状は、圧排すべき部位や圧排範囲に応じて複数存在する。 In addition, when an exclusion part is comprised from shape memory material, the shape is designed previously at the time of manufacture, and cannot be changed at the time of use. Accordingly, a retractor having various shapes, various lengths of movable parts, various bending angles, and the like should be provided according to the portion to be excluded and the exclusion range. There are a plurality of tip shapes depending on the part to be excluded and the exclusion range.
 本発明のリトラクターの圧排部は、臓器を損傷しないように、平滑な表面を有する。その遠位端は、鈍い(すなわち、鋭利でない)形状である。好ましくは、遠位端付近は、図3の(a)~(c)に示すようなピッグテイル様の形状(すなわち、丸まっている)である。遠位端の先端は、丸くなっており、好ましくは球状である。さらに、圧排部は、表面コーティングされていてもよい。コーティングには、医療器具のコーティングに通常用いられる素材が用いられ得る。例えば、多孔質ポリ四フッ化エチレン(ePTFE)膜、シリコーン膜、ポリウレタン膜、ポリエチレンテレフタラート(ダクロン(登録商標))膜などで外表面がコーティングされていてもよい。 The retractor of the retractor of the present invention has a smooth surface so as not to damage the organ. Its distal end is dull (ie not sharp). Preferably, the vicinity of the distal end has a pigtail-like shape (ie, rounded) as shown in FIGS. The tip of the distal end is rounded and preferably spherical. Furthermore, the exclusion part may be surface-coated. For the coating, materials usually used for coating medical devices can be used. For example, the outer surface may be coated with a porous polytetrafluoroethylene (ePTFE) film, a silicone film, a polyurethane film, a polyethylene terephthalate (Dacron (registered trademark)) film, or the like.
 形状記憶材料で構成される場合、圧排部は、処置具チャンネルに挿入される場合は可撓性の棒状になり、そして処置具チャンネルから管腔内に露出すると、記憶させた形状(例えば、屈曲型の形状)を発現する。処置具チャンネル内では、チャンネルの内腔によって物理的に真っ直ぐな棒状にされるか、あるいは形状変態温度より高いまたは低い温度で真っ直ぐな棒状になるように形状記憶されている。管腔内での形状の発現は、形状変態温度より高いまたは低い温度により行われるか、あるいは物理的な拘束から解放されることにより行われ得る。 When constructed of shape memory material, the retraction portion becomes a flexible rod when inserted into the treatment instrument channel, and when exposed to the lumen from the treatment instrument channel, the retraction portion (eg, bent) The shape of the mold). In the treatment instrument channel, the shape is memorized so as to be formed into a straight rod shape physically by the lumen of the channel, or a straight rod shape at a temperature higher or lower than the shape transformation temperature. The expression of the shape in the lumen can be performed at a temperature above or below the shape transformation temperature, or by being released from physical constraints.
 本発明のリトラクターの導入部は、上記圧排部に延設され、そしてハンドル部と圧排部とを接続している。導入部の長さは、圧排部を対象とする管腔内に突出(または露出)させるに十分な長さであればよく、通常、軟性内視鏡用の処置具に延設されているワイヤー類と同等であり得る。導入部の外径は、上述のように処置具チャンネルの内径より小さく、通常3mm未満である。 The introduction part of the retractor of the present invention extends from the above-mentioned exclusion part, and connects the handle part and the exclusion part. The length of the introduction part is sufficient if it is long enough to protrude (or be exposed) into the lumen targeted for the exclusion part, and is usually a wire extending to the treatment instrument for a flexible endoscope Can be equivalent to The outer diameter of the introduction part is smaller than the inner diameter of the treatment instrument channel as described above, and is usually less than 3 mm.
 本発明のリトラクターの導入部を構成する可撓性材料は、圧排部を、処置具チャンネルを介して内視鏡の遠位端に送達しそして管腔内に突出(または露出)させることが可能な可撓性および強度を有する限り、特に限定されない。例えば、軟性内視鏡用の処置具(例えば、鉗子)に延設されるワイヤーであり得る。その素材は、ステントなどに用いられる可撓性の素材が挙げられる。例えば、医療用ステンレスである316Lステンレス、タンタル、コバルト合金、ナイチノール(ニッケル-チタン合金)などが挙げられる。これらのワイヤーは、例えば、コイル状ワイヤーやワイヤーメッシュであってもよい。この導入部は、軟性内視鏡の動きを妨げることなく、軟性内視鏡の動きに伴って処置具チャンネル内で一緒に動くことができる。あるいは、導入部を介して、圧排部を処置具チャンネルから管腔内にさらに押し出すこと、または圧排部の向きを管腔内で変化させることも可能である。 The flexible material constituting the introduction portion of the retractor of the present invention allows the retraction portion to be delivered to the distal end of the endoscope via the treatment instrument channel and protruded (or exposed) into the lumen. As long as it has possible flexibility and strength, it is not particularly limited. For example, it may be a wire extending to a treatment instrument (for example, forceps) for a flexible endoscope. The material includes a flexible material used for a stent or the like. For example, 316L stainless steel, tantalum, cobalt alloy, nitinol (nickel-titanium alloy), etc., which are medical stainless steels. These wires may be, for example, coiled wires or wire meshes. The introduction portion can move together in the treatment instrument channel in accordance with the movement of the flexible endoscope without interfering with the movement of the flexible endoscope. Alternatively, the exclusion part can be further pushed out from the treatment instrument channel into the lumen through the introduction part, or the direction of the exclusion part can be changed in the lumen.
 導入部には、必要に応じて、ハンドル部の操作によって圧排部の形状を変化させるための手段が備えられ得る。例えば、圧排部を構成する形状記憶合金の形状変態温度の変化により、記憶形状を発現させる場合は、熱伝達手段が併設される。熱伝達手段としては、周囲に絶縁および断熱処理が施された可撓性の電熱線が挙げられる。 The introduction part may be provided with means for changing the shape of the exclusion part by operating the handle part as necessary. For example, in the case where the memory shape is expressed by a change in the shape transformation temperature of the shape memory alloy constituting the exclusion portion, a heat transfer means is additionally provided. Examples of the heat transfer means include flexible heating wires that are insulated and heat-insulated.
 本発明のリトラクターのハンドル部は、上記導入部の近位端に備えられる。ハンドル部の操作によって、圧排部および導入部を、内視鏡の処置具チャンネルに挿入して、圧排部を内視鏡の遠位端に送達しそして管腔内に突出(または露出)させることができる。例えば、ハンドル部にダイアルを設け、このダイアルを操作する(例えば、内視鏡の軸周囲に沿って回転させる)ことによって、圧排部を処置具チャンネル中で進入または後退させる構造であってもよい。 The handle portion of the retractor of the present invention is provided at the proximal end of the introduction portion. By operating the handle part, the exclusion part and the introduction part are inserted into the treatment instrument channel of the endoscope, and the exclusion part is delivered to the distal end of the endoscope and protruded (or exposed) into the lumen. Can do. For example, a structure may be adopted in which a dial is provided in the handle portion, and the dial is moved into or out of the treatment instrument channel by operating the dial (for example, rotating around the axis of the endoscope). .
 このハンドル部は、圧排部の形状を変化させるように操作可能である。圧排部の形状を変化させる方法は、圧排部の構成に応じて適宜決定される。例えば、上記のように形状記憶合金の形状変態温度の変化により、形状を発現させる場合は、ハンドル部に備えられた温度調節手段(例えば、電源に接続された発熱装置)により、熱伝達手段を介して圧排部を所定の温度にするように調節して、圧排部の形状を変化させる。 This handle part can be operated to change the shape of the exclusion part. The method of changing the shape of the exclusion portion is appropriately determined according to the configuration of the exclusion portion. For example, when the shape is expressed by the change in the shape transformation temperature of the shape memory alloy as described above, the heat transfer means is changed by the temperature adjusting means (for example, a heating device connected to the power source) provided in the handle portion. The shape of the exclusion part is changed by adjusting the exclusion part to a predetermined temperature.
 ハンドル部の形状および構造は、上記のような機能を有する限り、特に限定されない。器具の操作者が取り扱いやすく、当該技術分野で通常採用されるサイズおよび形状であり得る。 The shape and structure of the handle part are not particularly limited as long as it has the above functions. It may be of a size and shape that is easy for the operator of the instrument to handle and is normally employed in the art.
 本発明のリトラクターは、軟性内視鏡の処置具チャンネルから管腔臓器内に挿入され、圧排部が所定の形状(例えば、記憶した形状)を発現する。この圧排部を、内視鏡でモニターしながら、ハンドル部による操作または内視鏡自体の操作によって、管腔の内壁に接触させて、内壁を押し付けたり、押し上げたりする。この操作により、腹腔内での手術などにおいて管腔の外壁に必要とされる圧排、開排、牽引、または挙上を実現することができる。管腔臓器の外壁に適切なトラクションを得ることができ、腹腔内において術野を確保することもできる。あるいは、例えば、大腸内の粘膜面を展開し、襞を拡げることによって、例えば、襞に隠れていたポリープ全体を観察することで通常の内視鏡での処置が可能となる。 The retractor of the present invention is inserted into a luminal organ from the treatment instrument channel of the flexible endoscope, and the exclusion part expresses a predetermined shape (for example, a memorized shape). While this exclusion part is monitored by an endoscope, the inner wall is pressed or pushed up by being brought into contact with the inner wall of the lumen by an operation with the handle part or an operation of the endoscope itself. By this operation, it is possible to realize the exclusion, opening, traction, or elevation required for the outer wall of the lumen in surgery or the like in the abdominal cavity. Appropriate traction can be obtained on the outer wall of the luminal organ, and a surgical field can be secured in the abdominal cavity. Alternatively, for example, by expanding the mucosal surface in the large intestine and expanding the fold, for example, by observing the entire polyp hidden in the fold, treatment with a normal endoscope becomes possible.
 管腔臓器の圧排方法を、本発明のリトラクターおよび胃内視鏡を用いた場合を例に挙げて、図2~4を参照しながら具体的に説明する。 The method for excluding a luminal organ will be described in detail with reference to FIGS. 2 to 4, taking as an example the case of using the retractor and gastroscope of the present invention.
 胃内視鏡40を、経口的に胃S内に挿入し、本発明のリトラクター1を処置具チャンネル42から胃S内へ挿入する。次いで、圧排部10を完全に胃S内に露出させ、記憶形状を発現させる(図2および図4(a)参照)。胃内視鏡40の観察光学系41によるモニタリング下、圧排部10を胃壁に接触させて胃壁を押し付ける(図4(a))。次いで、胃内視鏡40を移動または屈曲させる操作を行うことによって、胃壁を内部から圧排部10によって持ち上げる(図4(b))。腹腔において胃壁の一部が挙上され、周囲との間に緊張ができ、腹腔内で手術の操作をしやすくなる。したがって、この操作により、体表の切開を行うことなく、胃を圧排することができる。 The stomach endoscope 40 is orally inserted into the stomach S, and the retractor 1 of the present invention is inserted into the stomach S from the treatment instrument channel 42. Next, the exclusion part 10 is completely exposed in the stomach S to develop a memory shape (see FIG. 2 and FIG. 4A). Under the monitoring by the observation optical system 41 of the gastroscope 40, the exclusion portion 10 is brought into contact with the stomach wall and pressed against the stomach wall (FIG. 4 (a)). Next, by performing an operation of moving or bending the stomach endoscope 40, the stomach wall is lifted from the inside by the exclusion unit 10 (FIG. 4B). A part of the stomach wall is raised in the abdominal cavity and tension is created between the stomach and the surroundings, making it easier to operate in the abdominal cavity. Therefore, by this operation, the stomach can be evacuated without incising the body surface.
 本発明のリトラクターは、主として胃壁を内腔側からリトラクションするデバイスとして記載したが、例えば、大腸内腔で使用すれば、大腸切除術にも応用可能である。大腸内腔での使用例を、図5および6を参照しながら、大腸内のポリープを切除する場合を例に挙げて説明する。 Although the retractor of the present invention has been described mainly as a device for retracting the stomach wall from the lumen side, for example, when used in the colon cavity, it can also be applied to a colectomy. An example of use in the colon cavity will be described with reference to FIGS. 5 and 6 by taking as an example the case of removing a polyp in the colon.
 まず、本発明のリトラクター1を大腸内視鏡40の処置具チャンネルを通して大腸C内に存在するポリープP付近に挿入する(図5)。ここで、大腸C内のポリープPは、大腸内視鏡40から見た場合、大腸壁の襞により部分的に隠れている(図6(a))。そこで、本発明のリトラクター1を大腸内視鏡40の処置具チャンネルを通してポリープPの周囲に配置し(図6(b))、次いで記憶形状を発現させたリトラクター1の圧排部をポリープP周囲の大腸壁に押し当てて、ポリープP全体、特にその基部が見えるように大腸壁を圧排する(図6(c))。このように術野が確保できるため、大腸内視鏡40の処置具チャンネルを通して挿入した電気メス50によってポリープPを確実に処理(例えば、基部を通る血管ごと結紮した上で切除するなど)することができる(図6(d))。 First, the retractor 1 of the present invention is inserted in the vicinity of the polyp P existing in the large intestine C through the treatment instrument channel of the large intestine endoscope 40 (FIG. 5). Here, the polyp P in the large intestine C is partially hidden by wrinkles on the large intestine wall when viewed from the large intestine endoscope 40 (FIG. 6A). Therefore, the retractor 1 of the present invention is disposed around the polyp P through the treatment instrument channel of the colonoscope 40 (FIG. 6B), and then the exclusion part of the retractor 1 that expresses the memory shape is defined as the polyp P. By pressing against the surrounding large intestine wall, the entire large polyp P, in particular, the base portion thereof is crushed so that it can be seen (FIG. 6C). Since the surgical field can be secured in this way, the polyp P is reliably processed (for example, excised after ligating the whole blood vessel passing through the base) with the electric knife 50 inserted through the treatment instrument channel of the colonoscope 40. (FIG. 6D).
 本発明のリトラクターは、軟性内視鏡の処置具チャンネルを経由して管腔臓器の内腔へ挿入され、予め設計された形状を内腔で速やかに発現する。その発現した先端形状を有する圧排部を用いて、管腔臓器を内腔側から圧排・開排し、例えば、NOTESによる腹腔での手術操作を補助できる。 The retractor of the present invention is inserted into the lumen of a luminal organ via a treatment instrument channel of a flexible endoscope, and quickly develops a predesigned shape in the lumen. The evacuation part having the expressed tip shape is used to evacuate and open the luminal organ from the lumen side, and for example, the surgical operation in the abdominal cavity by NOTES can be assisted.
 本発明のリトラクターを用いれば、腹腔鏡の挿入経路以外に臓器を圧排するための体表からの開口通路を必要とすることなく、術野を確保することができる。また、視野を確保しながら圧排操作を行うことが可能であるため、例えば、消化管腔に小さな病変がある場合、その病変を損傷することなく操作することが可能である。さらに、使用中に器具による組織の挟み込みや損傷を生じることもない。 Using the retractor of the present invention, the surgical field can be secured without requiring an open passage from the body surface for excluding the organ other than the insertion path of the laparoscope. Further, since the exclusion operation can be performed while securing the visual field, for example, when there is a small lesion in the digestive tract cavity, the operation can be performed without damaging the lesion. Furthermore, there is no tissue pinching or damage caused by the instrument during use.
 より具体的には、本発明のリトラクターは、経腟NOTESでは、胃切除術、食道切除術、小腸切除術、脾切除術(胃を内腔から展開して胃と脾との間を展開する)などにおいて、胃内視鏡経由で応用可能である。また、経胃NOTESでは、結腸切除術、直腸切除術、小腸切除術などにおいて、腸内視鏡経由で応用できる。あるいは、婦人科や泌尿器科領域にも応用可能である。 More specifically, the retractor of the present invention is a gastric resection, an esophagectomy, a small intestine resection, a splenectomy (expanding between the stomach and the spleen by expanding the stomach from the lumen) Etc.) and can be applied via a gastroscope. Transgastric NOTES can be applied via an enteroscope in colectomy, rectal resection, small intestine resection, and the like. Alternatively, it can be applied to gynecology and urology.
 さらに、本発明のリトラクターは、NOTESに限らず、腹腔鏡下手術や内視鏡手術、あるいは開腹手術においても応用可能である。例えば、通常の腹腔鏡下手術において消化管の適切なトラクションを得る目的で、当該消化管の内腔に内視鏡を経由して挿入して用いることができる。このような操作により、腹腔鏡下に用いる臓器圧排子は不要となり、腹部の切開創を減らすことが可能となる。 Furthermore, the retractor of the present invention can be applied not only to NOTES but also to laparoscopic surgery, endoscopic surgery, or open surgery. For example, in order to obtain appropriate traction of the gastrointestinal tract in ordinary laparoscopic surgery, the gastrointestinal tract can be inserted into the lumen of the gastrointestinal tract via an endoscope and used. Such an operation eliminates the need for an organ repellent used under a laparoscope, thereby reducing the abdominal incision.
 また、本発明のリトラクターは、通常の消化管内視鏡(胃カメラや大腸カメラ)において複雑な操作を行う際に補助的に使用することも可能である。例えば、アクセスが困難な襞の裏側に存在するポリープを、本発明のリトラクターを用いて壁を展開することによって正面視し、内視鏡的に切除することも可能である。 Also, the retractor of the present invention can be used as an auxiliary when performing complex operations in a normal gastrointestinal endoscope (stomach camera or colon camera). For example, a polyp present on the back side of a coral that is difficult to access can be viewed from the front by deploying a wall using the retractor of the present invention, and can be excised endoscopically.
 1   リトラクター
 10  圧排部
 20  導入部
 30  ハンドル部
 40  内視鏡
 41  観察光学系(カメラレンズ)
 42  処置具チャンネル
 50  電気メス
 S   胃
 C   大腸
 P   ポリープ
DESCRIPTION OF SYMBOLS 1 Retractor 10 Exclusion part 20 Introduction part 30 Handle part 40 Endoscope 41 Observation optical system (camera lens)
42 treatment instrument channel 50 electric knife S stomach C large intestine P polyp

Claims (10)

  1.  鈍い形状の遠位端を有する圧排部、該圧排部に延設される導入部、および該導入部の近位端に設けられたハンドル部を備えるリトラクターであって、
     該圧排部および該導入部が、管腔臓器の体表開口部から該管腔内へ挿入される軟性内視鏡の処置具チャンネルに挿入可能な外径を有し、
     該圧排部が、該処置具チャンネルから該管腔内部に突出されると所定の形状を発現し、そして平滑な表面を有し、
     該導入部が、可撓性材料から構成され、そして
     該ハンドル部が、該圧排部の形状を変化させるように操作可能である、
    リトラクター。
    A retractor comprising an exclusion part having a blunt-shaped distal end, an introduction part extending to the exclusion part, and a handle part provided at the proximal end of the introduction part,
    The exclusion portion and the introduction portion have an outer diameter that can be inserted into a treatment instrument channel of a flexible endoscope that is inserted into the lumen from a body surface opening of a hollow organ,
    The exclusion portion develops a predetermined shape when projected from the treatment instrument channel into the lumen, and has a smooth surface;
    The introducing portion is made of a flexible material, and the handle portion is operable to change the shape of the exclusion portion;
    Retractor.
  2.  前記圧排部が、形状記憶材料から構成されている、請求項1に記載のリトラクター。 The retractor according to claim 1, wherein the exclusion portion is made of a shape memory material.
  3.  前記形状記憶材料が、形状記憶合金である、請求項2に記載のリトラクター。 The retractor according to claim 2, wherein the shape memory material is a shape memory alloy.
  4.  前記圧排部が、表面コーティングされている、請求項1から3のいずれかの項に記載のリトラクター。 The retractor according to any one of claims 1 to 3, wherein the exclusion portion is surface-coated.
  5.  前記圧排部が、15~20cmの長さを有する、請求項1から4のいずれかの項に記載のリトラクター。 The retractor according to any one of claims 1 to 4, wherein the exclusion portion has a length of 15 to 20 cm.
  6.  前記リトラクターが、腹腔鏡下手術およびNOTESからなる群より選択される手術において使用可能である、請求項1から5のいずれかの項に記載のリトラクター。 The retractor according to any one of claims 1 to 5, wherein the retractor can be used in a surgery selected from the group consisting of laparoscopic surgery and NOTES.
  7.  管腔臓器の圧排方法であって、
     処置具チャンネルを備える軟性内視鏡を、管腔臓器の体表開口部から該管腔内へ挿入する工程;
     リトラクターを、該処置具チャンネルに挿入する工程であって、該リトラクターが、請求項1から6のいずれかの項に記載のリトラクターである、工程;
     該リトラクターの圧排部を該管腔臓器の内腔へ突出させて、任意の形状を発現させる工程;および
     該圧排部を該管腔臓器の内壁に接触させて、該内壁を圧排する工程
    を包含する、方法。
    A method for excluding a luminal organ,
    Inserting a flexible endoscope having a treatment instrument channel into a lumen from a body surface opening of a luminal organ;
    Inserting the retractor into the treatment instrument channel, wherein the retractor is the retractor according to any one of claims 1 to 6;
    Projecting the retraction part of the retractor into the lumen of the luminal organ to express an arbitrary shape; and bringing the retraction part into contact with the inner wall of the luminal organ to relieve the inner wall. The method of inclusion.
  8.  腹腔鏡下手術およびNOTESからなる群より選択される手術において行われる、請求項7に記載の方法。 The method according to claim 7, wherein the method is performed in a surgery selected from the group consisting of laparoscopic surgery and NOTES.
  9.  腹腔内手術または管腔内手術において術野を確保する方法であって、
     処置具チャンネルを備える軟性内視鏡を、管腔臓器の体表開口部から該管腔内へ挿入する工程;
     リトラクターを、該処置具チャンネルに挿入する工程であって、該リトラクターが、請求項1から6のいずれかの項に記載のリトラクターである、工程;
     該リトラクターの圧排部を該管腔臓器の内腔へ突出させて、任意の形状を発現させる工程;および
     該圧排部を該管腔臓器の内壁に接触させて、該内壁を圧排し、該腹腔内または該管腔内での術野を確保する工程
    を包含する、方法。
    A method for securing a surgical field in intraabdominal surgery or intraluminal surgery,
    Inserting a flexible endoscope having a treatment instrument channel into a lumen from a body surface opening of a luminal organ;
    Inserting the retractor into the treatment instrument channel, wherein the retractor is the retractor according to any one of claims 1 to 6;
    Allowing the retractor of the retractor to project into the lumen of the luminal organ to develop an arbitrary shape; and contacting the evacuation part with the inner wall of the luminal organ to squeeze the inner wall, Securing a surgical field within the abdominal cavity or in the lumen.
  10.  前記腹腔内手術が、腹腔鏡下手術およびNOTESからなる群より選択される、請求項9に記載の方法。 10. The method of claim 9, wherein the intra-abdominal surgery is selected from the group consisting of laparoscopic surgery and NOTES.
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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013043791A1 (en) * 2011-09-21 2013-03-28 Cook Medical Technologies Llc Twist-in spring-skirt-like-sphincterotome
US9433747B2 (en) 2005-02-03 2016-09-06 Inventio Llc Twist-in spring-skirt-like sphincterotome
DE102016004811A1 (en) * 2016-04-20 2017-10-26 Rheinisch-Westfälische Technische Hochschule (Rwth) Aachen Hollow organ anchoring device
US10028731B2 (en) 2013-11-12 2018-07-24 Genzyme Corporation Barrier application device
CN109350147A (en) * 2018-12-21 2019-02-19 遵义医学院附属医院 A kind of laparoscopic surgery drawing hook

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014062784A1 (en) * 2012-10-19 2014-04-24 Cook Medical Technologies Llc Self-coiling stylet needle device

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08336538A (en) * 1995-06-12 1996-12-24 Olympus Optical Co Ltd Vital operating appliance
JP2008259701A (en) * 2007-04-12 2008-10-30 Olympus Corp Apparatus inserted into living body

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08336538A (en) * 1995-06-12 1996-12-24 Olympus Optical Co Ltd Vital operating appliance
JP2008259701A (en) * 2007-04-12 2008-10-30 Olympus Corp Apparatus inserted into living body

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9433747B2 (en) 2005-02-03 2016-09-06 Inventio Llc Twist-in spring-skirt-like sphincterotome
WO2013043791A1 (en) * 2011-09-21 2013-03-28 Cook Medical Technologies Llc Twist-in spring-skirt-like-sphincterotome
US10028731B2 (en) 2013-11-12 2018-07-24 Genzyme Corporation Barrier application device
DE102016004811A1 (en) * 2016-04-20 2017-10-26 Rheinisch-Westfälische Technische Hochschule (Rwth) Aachen Hollow organ anchoring device
CN109350147A (en) * 2018-12-21 2019-02-19 遵义医学院附属医院 A kind of laparoscopic surgery drawing hook

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