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1077 Enteric Prostheses
Fig. 7.4 WallFlex enteral stent. ( a ) WallFlex enteral stent has a fl are at the proximal end and roundly angled edges. ( b ) Three radiopaque markers on the delivery system enable precise stent deployment. The stent can be recon­strained at any time up to when the exterior tube marker
Evolution Duodenal Stent
The Evolution duodenal stent is manufactured by Cook Medical Inc. (Winston-Salem, NC, USA; Fig. 7.5 ). This is a TTS, self-expandable metal uncovered stent made of braided nitinol with a single-wire woven structure. This stent has proxi­mal and distal fl anges to prevent stent migration. The diameter of the fl ared ends is 27 mm with a length of 20 mm. The unconstrained body diam­eter is 22 mm and unconstrained lengths are 6, 9, and, 12 cm. The stent comes preloaded on a 10-F, 230-cm delivery system.
There are eight radiopaque markers on the stent (four on each end) in addition to the radiopaque mesh structure to provide fl uoroscopic visualization. An endoscopic marker on the intro­ducer system indicates the proximal end of the stent within the sheath. The Evolution duodenal stents are recapturable up to approximately 50% of stent deployment. The stents foreshorten by approximately 45–50%.
band ( dark solid arrow ) reaches the deployment limit marker band ( closed arrowhead ). A postdeployment marker band ( open arrowhead ) identi fi es the approximate fi nal position of the proximal end of the stent when fully expanded
Niti-S Pyloric/Duodenal Stent
Niti-S is the registered trademark of Taewoong Medical, Seoul, Korea. The Niti-S (ComVi type) is a unique triple-layered covered stent sand­wiched designed to overcome tumor ingrowth and an uncovered outer stent to reduce migration.
Niti-S Pyloric/Duodenal Uncovered Stent: D Type
The Niti-S pyloric/duodenal uncovered stent – D type – is a self-expandable metal uncovered stent made of braided nitinol, which is woven with knitted-interlock structure (D type, Fig. 7.6a ). “D type” denotes “double wire type” in which two separate wires are woven into a stent mesh. Unlike the S type (single wire type), individual cells of D-type stent are not fi xed and can overlap with each other at the curved areas where the stent is bent (Fig. 7.6b, c ), designed to avoid abrupt luminal narrowing at the fl exed area. The
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C.G. Kim and I.J. Choi
Fig. 7.5 Evolution duodenal stent. This stent is a through the scope, uncovered enteral stent with fl anges at both ends to prevent stent migration
structural characteristics provide high fl exibility and conformability.
This stent is a straight type, with the same diameter on body and both ends with round edges to reduce the risk of tissue injury. The uncon­strained body diameter is available in 18, 20, 22, and 24 mm, and unconstrained lengths are 6, 8, 10, and 12 cm. In addition to the radiopacity of the mesh structure, there are ten platinum radiopaque markers – four each at the distal/ proximal end and two at middle portion to pro­vide optimal fl uoroscopic visualization. The stent can be inserted by TTS or OTW methods and comes preloaded on a 10-F delivery system. The length of the delivery system is 180 cm for TTS and 135 cm for OTW placement. After complete deployment, the shortening rate of this enteral stent is 17%. It is not reconstrainable at any point during deployment.
Niti-S Pyloric/Duodenal Stent: ComVi Type
This is a newly designed covered enteral stent to overcome both stent migration and reocclusion. This stent has a unique design of a triple-layered sandwich structure. The stent is made of two nitinol-braided outer and inner D-type stents with a PTFE membrane between them (Fig.
7.6d, e ).
The outer exposed stent mesh is expected to reduce migration by embedding itself into the tumor and surrounding normal tissue and a central PTFE membrane that prevents tumor ingrowth [
20 ] . There are 5 or 15-mm uncovered
portions at each end and also looped edges to reduce the risk of mucosal injury.
Available unconstrained body diameters are 18 and 20 mm, and unconstrained lengths and radiopaque markers, and are same as the uncov­ered stent (D type). The stent comes preloaded on a 10.5 F for TTS or OTW delivery. Other charac­teristics of the delivery system and the shortening rate of stent are similar to the D-type stent.
Niti-S Pyloric/Duodenal Stent: S Type
The Niti-S pyloric/duodenal stent – fully covered – is an older model but still currently available. It is a self-expandable metal stent woven into single-wired structure (Fig. 7.6c, f ). The covering material is sili- cone. It has fl anges (24 mm diameter and 15 mm long) at the ends to minimize the risk of migration and rounded edges to reduce the risk of tissue injury. A repositioning lasso on the proximal end is optional. Although the default model has coated fl anges on both ends, the manufacturer provides uncoated fl anges at the proximal and/or distal ends.
The unconstrained body diameter, lengths, radiopaque markers, and delivery system are the same as the ComVi-type stent. After complete deployment, the shortening rate of this enteral stent is 50–60%, and it is reconstrainable up to 70% stent deployment, allowing easy reposition­ing and improved control.
HANAROSTENT® Duodenum/Pylorus
HANAROSTENT is the registered trademark of M.I. Tech Co. Ltd., Seoul, Korea. It is available either uncovered stent or covered, both of similar design other than the silicone-coated body.
1097 Enteric Prostheses
Fig. 7.6 Niti-S pyloric/duodenal stents ( a ) Niti-S pyloric/ duodenal uncovered stent (D type) is an uncovered enteral stent. ( b ) A close-up of the bent D-type (double-wire knit- ted-interlock structure) stent shows overlapping cells because the individual cells are not fi xed. ( c ) A close-up of the bent S-type stent shows that individual cells do not
HANAROSTENT Duodenum/Pylorus, Noncovered (NNN)
This is an uncovered enteral stent. NNN denotes noncovered distal, center, and proximal parts of the stent, respectively. It is a self-expandable metal stent woven with the hook-type nitinol structure (Fig.
7.7a, b ). A repositioning lasso can
be attached at the proximal end if needed.
overlap. ( d ) Niti-S pyloric/duodenal stent (ComVi type) is a covered enteral stent. ( e ) ComVi type consists of three layers; an outer and inner nitinol meshes and a PTFE membrane between the meshes. ( f ) Niti-S pyloric/duode- nal stent (S type) is the old model of covered enteral stent. A reposition lasso (arrowhead) is optional
The unconstrained body diameter is 20 mm, and unconstrained lengths are 6, 8, 10, 12, 14, or 16 cm. This stent has fl ares (diameter 25 mm and length 13 mm) on both ends to reduce the risk of migration and rounded edges to reduce the risk of tissue injury. In addition to the radiopacity of the mesh structure, there are 12 gold radiopaque markers – four each located at the center and both
110
Fig. 7.6 (continued)
C.G. Kim and I.J. Choi
ends for excellent fl uoroscopic visualization, (Fig. 7.7b, c ).
This stent can be inserted TTS or OTW. The stent comes preloaded on a 10.2-F, 230-cm-long (for TTS delivery) or 10.5-F, 120-cm-long (for OTW delivery) HANARO delivery device. The olive tip of the delivery device is radiopaque, and the distal end of outer sheath has radiopaque tungsten rings. After complete deployment, there is a 20% foreshortening. It is reconstrainable up to 80% of fully stent deployment, allowing easy repositioning and improved control. The point of no return is marked in red on the inner shaft of handle (Fig.
7.7f , open arrowhead).
HANAROSTENT Duodenum/Pylorus (NCN and CCN)
HANAROSTENT® duodenum/pylorus (NCN) is a covered enteral stent. NCN means noncov­ered distal, covered center, and noncovered prox­imal portions. CCN means covered distal and center, and uncovered proximal portions. The body of this stent is coated by silicone. Flared uncovered portions are present on both ends
(NCN) or proximal end (CCN) to reduce the risk of migration (Fig. 7.7d, e ).
The covered stent has a similar design to the uncovered HANAROSTENT, except the number and location of radiopaque markers. There are 16 gold radiopaque markers (four each distal and proximal to the uncovered end, and distal and proximal to the covered end) to provide improved fl uoroscopic visualization.
BONASTENT ® Pyloric/Duodenal
The BONASTENT has a design similar to the HANAROSTENT, but another uniquely designed stent, BONASTENT M-Duodenal, is available and developed to enable biliary stent placement and adequate expansion through the lumen of the duodenal stent.
BONASTENT Pyloric/Duodenal Uncovered
BONASTENT is the registered trademark of Standard Sci-Tech Inc., Seoul, Korea. This is a self-expandable metal uncovered stent made of
1117 Enteric Prostheses
Fig. 7.7 HANAROSTENT® duodenum/pylorus stents. ( a ) HANAROSTENT duodenum/pylorus uncovered stent. This enteral stent has fl ares on both ends. ( b ) A close-up view of HANAROSTENT duodenum/pylorus uncovered stent shows hook-type wire structure and gold radiopaque marker ( arrowhead ). ( c ) Fluoroscopic view of radiopaque markers ( arrowhead ). ( d ) HANAROSTENT duodenum/
braided nitinol with a fi xed hook and cross-wired structure (Fig.
7.8a ). The cell size of the stent
mesh is 4 mm. The diameter of the fl ared ends is 6 mm larger than that of the body, and the length of fl are is 15 mm to minimize the risk of migra-
pylorus covered stent (NCN). Flares on both ends remain uncovered. ( e ) HANAROSTENT duodenum/pylorus cov- ered stent (CCN). Proximal end fl are remains uncovered. ( f ) Recapturing red marker ( open arrowhead ) and deploy- ment black markers. Left closed arrowhead denotes the starting point of stent deployment, and the right closed arrowhead indicates the fi nishing point of deployment
tion, and it has smooth ends to reduce the risk of tissue injury. The unconstrained body diameter is available in 18 and 20 mm, and unconstrained lengths are 6, 8, 10, 12, 14, and 16 cm. There are 12 platinum wire spring radiopaque markers
112
Fig. 7.7 (continued)
C.G. Kim and I.J. Choi
Fig. 7.8 BONASTENT® pyloric/duodenal stents. ( a ) BONASTENT pyloric/duodenal uncovered stent. This enteral stent has fl ares on both ends. ( b ) BONASTENT pyloric/duodenal covered stent. Flares on both ends are uncovered
(four each at the distal, center, and proximal por­tions of the stent).
The stent comes preloaded on a 10-F delivery system for TTS or OTW placement. The lengths for TTS delivery are 180 and 230 cm, and 120 cm for OTW placement. Stainless steel radiopaque
bands are on the proximal and distal parts of the delivery system inner shaft. After complete deploy­ment, the stent shortens by up to 30%. It is recon­strainable up to 80% stent deployment. There is a red marker on the stainless steel outer shaft of the delivery system to denote the point of no return.
1137 Enteric Prostheses
BONASTENT Pyloric/Duodenal Covered
This partially covered enteral stent has same design as the BONASTENT pyloric/duodenal, except that the body is coated with silicone. Flares on both ends remain uncovered to reduce the risk of migration (Fig. 7.8b ).
BONASTENT M-Duodenal
Patients with malignant gastric outlet obstruction often have combined or impending biliary obstruction [ 21 ] . In these patients, a biliary stent is recommended prior to duodenal stent insertion through a percutaneous or an endoscopic approach. If a conventional enteral stent is placed, access to the papilla and biliary tree can be very dif fi cult, and special maneuvers such as cutting the overlying wires or balloon dilating to widen the mesh structure of the duodenal stent are often required [ 21 ] . Moreover, biliary stents placed through the mesh of a conventional enteral stent rarely expand adequately because of the shape memory property of nitinol [ 14 ] . The BONASTENT M-Duodenal was developed to enable biliary stent placement and allow adequate expansion though the mesh structure of the duo­denal stent.
The stent consists of two portions: a fi xed por­tion with a woven fi xed hook and cross-wired structure similar to the uncovered BONASTENT pyloric/duodenal and a 3-cm un fi xed portion (M-portion) with an un fi xed cross-wired struc­ture. There are two stent types according to the location of the un fi xed portion. The central type has the un fi xed portion at the center of the stent, which is designed for type II bilioduodenal stric­tures that involve the second portion of duode­num with involvement of the papilla (Fig. 7.9a ). The lateral type has the un fi xed portion at either the distal or proximal part of the stent (Fig. 7.9b ). The former is for type I bilioduodenal stenosis involving the duodenal bulb or the fi rst portion without papillary involvement. The latter is for type III bilioduodenal stenosis involving the third portion of the duodenum with sparing of the papilla. These features contribute to easy inser­tion of a biliary stent through the mesh wall of the un fi xed portion of the duodenal stent without resistance (Fig. 7.9c, d ). There are 16 platinum
wire spring radiopaque markers (four each at both ends of the un fi xed portion, and proximal and distal ends) for improved fl uoroscopic visualiza­tion of the entire stent and the un fi xed portions.
Although the initial model had a smaller stent mesh cell size of 2.5–2.75 mm, the current model has 4-mm cells in both fi xed and un fi xed portions [ 22 ] . The available diameter of BONASTENT M-Duodenal is 22 mm. Other speci fi cations of the fl ared ends and body are compatible with BONASTENT pyloric/duodenal uncovered.
EGIS Pyloric Stent
The EGIS pyloric stent is the enteral stent from S&G Biotech (Seongnam, Korea), which pro­vides various types of stents including EGIS pyloric stent-single bare, double bare, single­covered, double-covered, and Hercules SP pylo­ric stent, which consists of two stents. EGIS pyloric stent-double bare and Hercules SP pylo­ric stents have unique designs to minimize tumor ingrowth and stent migration.
EGIS Pyloric Stent, Single Bare and Double Bare
These are self-expandable metal uncovered stents made of braided nitinol, which are woven into a cross and hooked structures. There are two types of stents that differ in the number of layers of mesh wire: single bare and double bare (Fig. 7.10a, b ). Double bare is a unique double-layered structure created by crossing two stents resulting in a smaller diameter cell size (2–3 mm) with denser, numerous cells designed to reduce tumor ingrowth. EGIS pyloric stents lack fl ared ends and have round edges to reduce the risk of tissue damage and perforation. The unconstrained body diameters are 18, 20, 22, and 24 mm, and uncon­strained lengths are 6, 8, 10, and 12 cm. There are ten gold radiopaque markers (four at each end and two in the midportion). The stent comes pre­loaded on a 10-F delivery system for either TTS (length, 180 cm) or OTW (length, 120 cm) deployment. There is radiopaque tungsten at the distal end of the outer sheath. After complete deployment, the stent foreshortens by 32% in
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C.G. Kim and I.J. Choi
Fig. 7.9 BONASTENT® M-duodenal. Un fi xed por­tion of BONASTENT® M-duodenal enables biliary stents to be placed and allows expansion though the lumen of the duodenal stent. ( a ) Central type. Un fi xed portion is located on the center of the stent body for the second portion of duodenal strictures. ( b ) Lateral type. Un fi xed portion is located on the distal or
proximal part. ( c ) Fluoroscopic view showed placement of a BONASTENT M-duodenal central type across the duodenal stricture. ( d ) Fluoroscopic view showed biliary stent successfully placed through the un fi xed mesh of the duodenal stent (c and d, Courtesy of Prof. JH Moon, Soon Chun Hyang University School of Medicine, Bucheon/Seoul, Korea)
1157 Enteric Prostheses
Fig. 7.10 EGIS pyloric stent. ( a ) EGIS pyloric single bare stent. ( b ) The double-layered structure of EGIS pyloric double bare stent creates a smaller cell size. ( c ) EGIS pyloric single-covered stent is the old model
of S&G Biotech. ( d ) Double-covered EGIS pyloric stent is double-layered combination pyloric stent which is made of 2 nitinol-braided stents and a silicone membrane
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C.G. Kim and I.J. Choi
Fig. 7.11 Hercules SP pyloric stent. This dual stent consists of two stents. ( a ) Inner bare nitinol stent ( top ) and outer stent consist of each end bare nitinol stent and a central Dacron fabric without wire structure
single bare and 20% in double bare stents. These stents are not reconstrainable.
EGIS Pyloric Stent, Single Covered and Double Covered
The covered type of EGIS pyloric stent is avail­able in two models: single covered and double covered (Fig.
7.10c, d ). The older model single-
covered stent is fully covered with silicone and has 16 gold radiopaque markers (seven each at the ends and two on the midportion). After com­plete deployment, the stent foreshortens by 25%. EGIS pyloric stent double covered is the double­layered combination pyloric stent made of two nitinol-braided stents and a silicone membrane (Fig.
7.10d ). There are 5-mm uncovered portions
at the proximal and distal ends of the stent. Other characteristics are the same as EGIS pyloric stent double bare type.
( bottom ). ( b ) Assembly of the two stents consecutively inserted under fl uoroscopic guidance of the inner bare nitinol stent after insertion of the outer partially cov­ered stent
Hercules SP Pyloric Stent
The Hercules SP pyloric stent is a uniquely designed enteral stent from S&G Biotech designed to prevent tumor ingrowth and stent migration. This dual expandable stent consists of an outer partially covered stent and an inner bare nitinol stent which are inserted consecutively under fl uoroscopic guidance (OTW method, Fig.
7.11a, b ). The outer partially covered stent
consists of three parts – a proximal and distal bare nitinol stent, and a central Dacron fabric without wire structure [ 23 ] . Both proximal and distal bare nitinol stent parts are 28 mm in diam­eter and 25 mm long. The diameter of the central Dacron portion is 18 mm. After the outer par­tially covered stent is inserted, a bare inner nitinol stent is inserted to expand the wireless Dacron portion of the outer stent and to increase its radial