Gallbladder model
21 claims: 2 independent, 19 dependent
- 1外科用訓練のための解剖学的モデルであって、平坦な内面及び外面を有する人工肝臓層と、 内 面及 び外 面を有する人工筋膜層であって、前記人工筋膜層は、前記人工筋膜層の前 記外 面が前記人工肝臓層の前記平坦な内面を覆い、且つ、前記人工筋膜層と前記人工肝臓層との間に第1のポケットが形成されるように、前記人工肝臓層に取り付けられる、前記人工筋膜層と、前記第1のポケットの位置で前記人工筋膜層に取り付けられる人工胆嚢と、を含む、解剖学的モデル。
- 2平坦な内面及び平坦な外面を有する人工腹膜層を更に含み、前記人工腹膜層は、前記平坦な外面が前記人工胆嚢及び前記人工筋膜層の前記内面を覆い、且つ、前記人工腹膜層と前記人工筋膜層との間に第2のポケットが形成されるように、前記人工筋膜層に取り付けられる、請求項1記載の解剖学的モデル。
- 3前記人工腹膜層は、前記人工胆嚢に取り付けられている、請求項2記載の解剖学的モデル。
- 4前記人工腹膜層を前記人工肝臓層から遠ざかる方向に引くと、前記人工胆嚢が前記人工腹膜層と一緒に引っ張られる、請求項3記載の解剖学的モデル。
- 5前記人工腹膜層を引くと、前記第1のポケット及び前記第2のポケットがテント状になる、請求項3記載の解剖学的モデル。
- 6前記人工腹膜層を引くと、前記人工腹膜層が前記人工筋膜層に対してテント状になり、前記人工筋膜層が前記人工肝臓層に対してテント状になる、請求項3記載の解剖学的モデル。
- 7前記人工腹膜層の周囲は、前記人工筋膜層の周囲に取り付けられ、前記人工筋膜層の周囲は、前記人工肝臓層の周囲に取り付けられる、請求項3記載の解剖学的モデル。
- 8前記人工筋膜層の中間部分又は前記人工筋膜層の周囲から見て内方に位置する部分の大部分が、前記人工肝臓層に取り付けられておらず、且つ、前記人工肝臓層から分離して離れるように動くことができる状態となるように、前記第1のポケットが形成されている、請求項1記載の解剖学的モデル。
- 9前記人工胆嚢は、実際の人間の解剖学的構造体を真似るよう配置及び構成される複数の模擬解剖学的構造体を含み、前記複数の模擬解剖学的構造体は、模擬胆嚢管に連結された模擬胆嚢と、模擬総胆管に連結された模擬総肝管と、模擬胆嚢動脈と、模擬右肝動脈及び模擬左肝動脈に連結され且つ該模擬右肝動脈及び該模擬左肝動脈に枝分かれしている模擬総肝動脈と、を含む、請求項1記載の解剖学的モデル。
- 10前記人工胆嚢は、前記複数の模擬解剖学的構造体周りの周囲内に選択的に配置された取付部により、前記人工筋膜層の前 記内 面に取り付けられる、請求項9記載の解剖学的モデル。
- 11前記模擬胆嚢は、シリコーン又は熱可塑性エラストマーで成形された中実の、又は中空の球状構造体を含み、前記 模擬 胆嚢は、胆汁を真似るよう薄い緑色又は黄色である、請求項9記載の解剖学的モデル。
- 12前記模擬胆嚢管、前記模擬総肝管、及び前記模擬総胆管は、薄い緑色で染色されたシリコーン又は熱可塑性エラストマーで作られている、請求項9記載の解剖学的モデル。
- 13前記模擬胆嚢管、前記模擬総肝管、及び前記模擬総胆管は、中実の、又は中空の管状構造体である、請求項9記載の解剖学的モデル。
- 14前記模擬胆嚢動脈、前記模擬総肝動脈、前記模擬右肝動脈、及び前記模擬左肝動脈は、赤色で染色されたシリコーン又は熱可塑性エラストマーで作られている、請求項9記載の解剖学的モデル。
- 15前記模擬胆嚢動脈、前記模擬総肝動脈、前記模擬右肝動脈、及び前記模擬左肝動脈は、中実の、又は中空の管状構造体である、請求項9記載の解剖学的モデル。
- 16前記模擬胆嚢、前記模擬胆嚢管、前記模擬総肝管、及び前記模擬総胆管のうちの1つ又は2つ以上は、1つ又は2つ以上の模擬胆石を含み、前記1つ又は2つ以上の模擬胆石の各々は、プラスチックで作られた小さなビード状の構造体を有する、請求項9記載の解剖学的モデル。
- 17前記1つ又は2つ以上の模擬胆石は、前記 模擬 胆嚢の中空空間内に、及び/又は、前記模擬胆嚢管、前記模擬総肝管、及び前記模擬総胆管のうちの1つ又は2つ以上のルーメン内に配置される、請求項16記載の解剖学的モデル。
- 18前記人工肝臓 層 は、シリコーン又は熱可塑性エラストマーで成形され、前記人工肝臓 層 は、赤色である、請求項1記載の解剖学的モデル。
- 19前記人工肝臓層の前記外面は、湾曲した凸状である、請求項1記載の解剖学的モデル。
- 20前記人工筋膜層は、部分的に半透明であり、透明であり又は黄色で染色されたシリコーン又は熱可塑性エラストマーで作られている、請求項1記載の解剖学的モデル。
- 21前記人工腹膜層は、部分的に半透明であり、透明であり又は黄色で染色されたシリコーン又は熱可塑性エラストマーで作られている、請求項 2 記載の解剖学的モデル。
Independent claims21
30 paragraphs, as filed
This application relates to surgical training tools, particularly simulated tissue structures and models for teaching and practicing surgical procedures involving the gallbladder.
[Description of related applications] This application is an application claiming priority and interest in U.S. Provisional Patent Application No. 61/836,512 (title of invention: Gallbladder model) filed on June 18, 2013, and The application is hereby incorporated by reference in its entirety.
A common treatment method for gallstones and other gallbladder conditions is cholecystectomy, the surgical removal of the gallbladder from the liver bed. Laparoscopic cholecystectomy is the most common laparoscopic procedure and has replaced open cholecystectomy as the treatment of gallstones and as the first choice for gallbladder inflammation. Laparoscopic cholecystectomy advantageously requires smaller incisions, resulting in less pain, better cosmetic results, faster healing, and fewer complications such as inflammation and adhesions. few.
Laparoscopic cholecystectomy involves the insertion of several trocars or small diameter cylindrical tubes into the abdomen to allow the insertion of a trocar or small diameter cylindrical tube approximately 5 to 10 millimeters in diameter through which surgical instruments and a laparoscope are placed into the abdominal cavity. A small incision is required. The laparoscope illuminates the surgical field and sends a magnified image from inside the body to a video monitor, which provides the surgeon with a magnified view of organs and tissues. The surgeon performs the surgery by monitoring a live video feed and manipulating surgical instruments placed through the trocar.
In laparoscopic cholecystectomy, the patient is placed in a supine position on the operating table and anesthetized. It is best to make a small incision at the navel using a scalpel. A trocar is used to enter the abdominal cavity, deliver carbon dioxide gas, and enlarge it by insufflating the abdominal cavity, thereby creating a working space within the patient's abdominal region. The trocar may include a laparoscope in an inserted state for observing the state of penetration of the intra-abdominal space, the state of insertion, and the state of insufflation of the intra-abdominal space. An additional trocar is inserted in place located under the ribs. Using a laparoscope, identify the gallbladder floor covered by the peritoneum, grasp it with a surgical grasper passed through one of the trocars, and retract it. Using a second surgical grasper, retract the remainder of the gallbladder laterally to expose Calot's triangle. The Calot's triangle is the portion of the gallbladder anatomy bounded by the cystic duct, cystic artery, bile duct, and liver rim. The surgeon identifies the cystic duct and cystic artery. In this region, underlying structures are carefully skeletonized from the peritoneum, separating it from both the cystic duct and cystic artery. Introduce a surgical clip applier into one of the trocars and clip the clip to both the cystic duct and cystic artery in two locations. The cystic duct and artery are then divided between the two placement locations of the clip with surgical scissors, freeing the gallbladder for removal. The gallbladder is separated from the hepatic bed of the liver and removed through one of the trocars. During laparoscopic cholecystectomy, complications may arise due to gallbladder perforation, which is caused by excessive traction during retraction of the gallbladder from the liver bed or during dissection or removal from the abdomen. may occur. The outcome of laparoscopic cholecystectomy is greatly influenced by the training, experience, and skill of the surgeon performing the procedure. Lifelike functional and anatomically accurate models for use in laparoscopic training instruments are needed for residents and surgeons to learn and practice these surgical techniques. Ru.
The gallbladder model is not only useful for training residents and surgeons in laparoscopic cholecystectomy, but is also desirable for training residents and surgeons during laparoscopic common bile duct test incision. The common bile duct is a tube that connects the liver, gallbladder, and pancreas to the small intestine and pumps fluid to aid in digestion. Common bile duct exploratory dissection is a procedure used to determine whether gallstones or some other obstruction are blocking the flow of bile from the gallbladder or liver to the intestines. In laparoscopic common bile duct pilot incision, the abdominal cavity is accessed as in cholecystectomy described above. The surgeon identifies the common bile duct and makes a small hemi-circumferential incision in the common bile duct. A cholangiography catheter is inserted through one of the trocars into the insufflated abdominal cavity and then into an incision made in the common bile duct. A contrast agent or radiopaque fluid is introduced into the cystic duct and common bile duct, and X-rays are applied to reveal the location of any gallstones within the common bile duct. If gallstones are present, the obstruction will appear as a discontinuity in the flow of contrast medium. The gallstones are then surgically removed.
<p>To aid in patient postoperative outcomes and recovery, surgeons need the means to practice laparoscopic cholecystectomy and common bile duct test incisions from outside the operating room. The training model must be anatomically accurate and include all important landmarks normally visible during surgery to provide the surgeon or resident with the most realistic training possible. There is.</p>
<p>According to one aspect of the invention, an anatomical model for surgical training is provided. This model has a first layer with an inner and outer surface. The first layer has a defined thickness between the inner and outer surfaces. The first layer has a first perimeter and is configured to mimic at least a portion of the first anatomical structure. This model has a second layer with an inner and outer surface. The second layer defines a thickness between the inner and outer surfaces. The second layer defines a second perimeter and the second layer covers the first layer such that the outer surface of the second layer faces the inner surface of the first layer. The model has at least one second simulated anatomical structure, and the at least one second simulated anatomical structure has a third perimeter around the at least one simulated anatomical structure. It has established. At least one simulated anatomical structure is coupled to the inner surface of the second layer. The outer surface of the second layer is coupled to the inner surface of the first layer at least partially about the location of the at least one second simulated anatomical structure.</p><p>According to another aspect of the invention, an anatomical model for surgical training is provided. The model has an anatomical portion and a support removably connectable to the anatomical portion. The anatomical portion has at least a first layer with an inner surface and an outer surface interconnected to each other by a top side, a bottom side, a left side and a right side. The first layer has a defined thickness between the inner surface and the outer surface. The first layer is configured to mimic at least a portion of the liver. The top side of the first layer has a peak. This model has a simulated gallbladder positioned above the location of the crest. This model has a frame connected to at least the first layer. The frame has a first end connected to a second end by a central portion. The first end and second end of the frame are removably connectable to a support to maintain the anatomical portion in a substantially upright position. The frame does not extend into the locus of the peaks so that the first layer located at the locus of the peaks can flex relative to the frame.</p><p>According to another aspect of the invention, an anatomical model for surgical training is provided. This model has an anatomical part with a first layer. The first layer has inner and outer surfaces interconnected by a top side, a bottom side, a left side and a right side. The first layer has a defined thickness between the inner surface and the outer surface. The first layer is configured to mimic at least one anatomical structure. The anatomical portion has a second layer that includes at least one anatomical structure overlying the first layer. The anatomical portion has a frame with a first end interconnected to a second end by a central portion. At least a portion of the frame is embedded within the first layer with first and second ends of the frame extending out from the first layer. The model has a support and the first and second ends of the frame are removable to the support to hold the anatomical part in a substantially upright position relative to the support surface. Can be connected to</p><p>According to another aspect of the invention, a surgical simulation system is provided. The system includes an anatomical model. This model has anatomical parts. The anatomical portion has a first layer with an inner and outer surface interconnected by a top side, a bottom side, a left side and a right side. The first layer has a defined thickness between the inner surface and the outer surface. The first layer is configured to mimic at least one anatomical structure and defines a substantially flattened configuration. The model has a second layer that includes a plurality of anatomical structures connected to and covering the inner surface of the first layer. A support is connectable to the anatomical portion and configured to maintain the anatomical portion in a substantially perpendicular orientation relative to the support surface. The system further includes a surgical training instrument. The surgical training instrument has a base and a top cover coupled to and spaced from the base to define a simulated gas injection interior cavity between the top cover and the base. has been done. The internal cavity is at least partially obscured from direct viewing by the user. The top cover of the surgical training instrument has a hole or penetrable simulated tissue area. The top cover of the surgical training instrument is angled at an acute angle to the horizontal plane as measured from within the cavity. The anatomical model is positioned within the internal cavity at a distance opposite the acute angle such that the inner surface of the first layer faces the acute angle and the hole or penetrable simulated tissue area.</p><p>According to another aspect of the invention, an anatomical model for surgical training is provided. This model has anatomical parts. The anatomical portion has a first layer with an inner and outer surface interconnected by a top side, a bottom side, a left side and a right side. The inner surface is substantially planar and the first layer has a thickness defined between the inner surface and the outer surface. The first layer is configured to mimic at least a portion of the liver. The top side of the first layer has a peak. The anatomical portion has a second layer with inner and outer surfaces interconnected by a top side, a bottom side, a left side and a right side. The second layer covers the first layer such that the outer surface of the second layer faces the inner surface of the first layer. The outer surface of the second layer is coupled to the inner surface of the first layer along at least a portion of the first perimeter. The second layer defines a thickness between the inner surface and the outer surface, and the thickness of the second layer is less than the thickness of the first layer. The anatomical portion has a third layer that includes at least one simulated anatomical structure. At least one simulated anatomical structure is coupled to the inner surface of the second layer. The anatomical portion further has a fourth layer with inner and outer surfaces interconnected by a top side, a bottom side, a left side and a right side. A fourth layer covers the second and third layers such that the outer surface of the fourth layer faces the inner surface of the second layer and the at least one simulated anatomical structure. The outer surface of the fourth layer is coupled to the inner surface of the second layer along at least a portion of the second perimeter. A fourth layer defines a thickness between the inner surface and the outer surface, and the thickness of the fourth layer is less than the thickness of the first layer. The anatomical portion has a frame embedded at least partially within the first layer. The model has a support connectable to the frame to hold the anatomical portion in a substantially upright position.</p><p>According to another aspect of the invention, a gallbladder model is provided. This model allows the user to practice open cholecystectomy and common bile duct pilot dissection as well as laparoscopic cholecystectomy and common bile duct pilot dissection. The gallbladder model has an anatomical portion connected to a support. The anatomical portion includes a liver layer, a fascia layer, a gallbladder layer, a peritoneal layer, and a frame that are connected to each other and held in an upright orientation by a support.</p>
<figref num="1">1 is a top perspective view of an anatomical model of the present invention; FIG.</figref><figref num="2">1 is an exploded top perspective view of an anatomical model of the present invention; FIG.</figref><figref num="3">FIG. 3 is a side view of the liver layer of the anatomical part of the anatomical model of the present invention.</figref><figref num="4">FIG. 3 is a partial side view of the prongs of the frame of the anatomical part of the anatomical model of the present invention;</figref><figref num="5">1 is a cross-sectional side view of a support for an anatomical part of an anatomical model of the invention; FIG.</figref><figref num="6">1 is a top perspective view of a laparoscopic training instrument used with the anatomical model of the present invention; FIG.</figref><figref num="7">1 is a top perspective view of the frame and support of the anatomical model of the present invention; FIG.</figref>
Referring now to FIG. 1, a gallbladder model 10 of the present invention is shown. Gallbladder model 10 has an anatomical portion 12 removably connected to a support 14. Substantially flattened anatomical portion 12 is maintained in an upright configuration by support 14. In the cholecystectomy described above in the background section of this specification, the gallbladder base is visible and is retracted. In doing this, the remainder of the gallbladder, located anteriorly of the patient and below the liver, is exposed and made visible along with Calot's triangle within the gas cavity. This retraction lifts part of the lower or inferior portion of the right lobe of the liver. With the liver and gallbladder located substantially in the X-Z plane or anterior plane of the patient, and with the liver and gallbladder elevated in retraction substantially into the Y-plane or transverse plane of the patient, the present invention The gallbladder model 10 is a substantial or partial projection of at least a portion of the retracted liver and gallbladder onto the XY plane or transverse plane of the patient. Gallbladder model 10 therefore represents a substantially planar projection of a retracted liver and gallbladder within a simulated insufflation cavity. Therefore, the morphology of the gallbladder model 10 advantageously provides a surgical approach to a simulated gallbladder that is already in a retracted vertical orientation when viewed by a user approaching the gallbladder from the location of the umbilicus. do. Additionally, the configuration of the gallbladder model 10 allows for practice by a user without the need for another user to hold some parts of the model in a retracted position using a grasper; thus, the model 10 advantageously , designed to be used by one person at a time. Furthermore, in Model 10, only a portion of the liver, specifically the right lobe of the liver, is simulated. The entire biliary structure, including the gallbladder, along with the right lobe, is included in the model.
Referring now to FIG. 2, an exploded view of gallbladder model 10 having anatomical portion 12 connected to support 14 is shown. Anatomical portion 12 includes a liver layer 16, a fascial layer 18, a gallbladder layer 20, a peritoneal layer 22, and a frame 24, which are interconnected. Next, each layer will be explained in detail.
Still referring to FIG. 2, the liver layer or first layer 16 is molded from red-dyed silicone or thermoplastic elastomer and is configured to mimic a retracted portion of the liver. In particular, liver layer 16 is shaped to represent a portion of the right lobe of a human liver that has been retracted to expose the gallbladder and Calot's triangle. Referring to FIG. 3, the liver layer 16 has a flat and planar inner surface 26 and a convex curved outer surface 28. The inner and outer surfaces 26, 28 are interconnected along four sides: a curved top side, a straight bottom side, a left side and a right side; The side and bottom sides are interconnected. The curved top side has a peak 30 near or at the left side of the model. The top side curves downwardly from the peak 30 to a lower portion interconnected to the right side. This ridged shape resembles a substantially planar projection of the retracted right lobe of a human liver. The mountain portion 30 has a longer length than other portions of the liver layer 16. The thickest portion of liver layer 16 is approximately 0.5 inches (12.7 mm) and is located approximately midway. In one form, as shown in FIG. 3, the frame 24 is attached to the liver layer 16 such that at least a portion of the frame 24 is located inside the liver layer 16 and a portion of the frame 24 is located outside the liver layer 16. Molded directly inside. The frame 24 will be explained in detail below.
Still referring to FIG. 2, the fascia layer or second layer 18 is a thin, partially translucent, transparent or slightly yellow-dyed thermoplastic elastomer or silicone. The layer is approximately 0.01 to 0.03 inches (0.254 to 0.762 mm) thick. Fascia layer 18 is of the same ridged shape as liver layer 16 and is sized and shaped to cover liver layer 16. Fascia layer 18 has an inner surface and an outer surface, the outer surface covering a portion of the inner surface 26 of liver 16. The fascial layer 18 is attached to the liver layer 16 by an adhesive, the adhesive being disposed at least along the periphery and extending inwardly from the middle portion of the fascial layer 18 or the periphery of the fascial layer 18. Most of the located portions are not attached to the liver layer 16 and are instead free to move and able to separate and leave the liver layer 16. This fascia layer 18 does not exist in reality, i.e. there is no tissue layer between the gallbladder and the liver, and the gallbladder model 10 of the invention advantageously allows for the incision and removal of the gallbladder from the liver. It has a fascial layer 18 that mimics the This advantage will be explained in detail below.
Still referring to FIG. 2, the gallbladder layer or third layer 20 has at least one body component. In Figure 2, at least one body component is a plurality of anatomical structures. For example, the gallbladder layer 20 is connected to a body wall 32 connected to a cystic duct 34, a common hepatic duct 36 connected to a common bile duct 38, a cystic artery 40, and a right hepatic artery 44 and a left hepatic artery 46. It has a common hepatic artery 42 that branches into these. All of these anatomical structures are configured to mimic actual human anatomy and are positioned within the gallbladder layer 20 in an anatomically accurate manner. Gallbladder 32 is a hollow spherical structure molded from silicone or other thermoplastic material that is dyed a light green or yellow color to mimic bile. In another form, gallbladder 32 is a solid, non-hollow structure. The cystic duct 34, common hepatic duct 36 and common bile duct 38 are also made of light green stained silicone or thermoplastic material. The cystic duct 34 is tubular in shape, has a tapered end, and has a diameter of approximately 0.15 to 0.25 inches (3.81 to 6.35 mm). In one form, the gallbladder liver 34 has a lumen with a minimum inner diameter of 0.15 inches (3.81 mm) and a maximum outer diameter of 0.25 inches (6.35 mm) such that the lumen clips The diameter is small enough to allow insertion of a catheter and large enough to allow insertion of a catheter. In yet another form, the cystic duct 34 includes a lumen with an inner surface that is lubricated with a lubricant. In yet another form, the cystic duct 34 has a large outer diameter compared to the dimensions of the actual cystic duct 34 to facilitate training and insertion of the catheter into the lumen. The common hepatic duct 36 and common bile duct 38 are also tubular in shape and have a diameter of approximately 0.15 inches (3.81 mm). In one form, the cystic duct 34, common hepatic duct 36, and common bile duct 38 are hollow; in another form, they are solid. The cystic artery 40, common hepatic artery 42, right hepatic artery 44, and left hepatic artery 46 are made of silicone or thermoplastic material that is stained red and molded into a tubular shape having a diameter of approximately 0.15 inches (3.81 mm). It is made. In one form, the cystic artery 40, common hepatic artery 42, right hepatic artery 44, and left hepatic artery 46 are hollow; in another form, they are solid structures. Gallbladder layer 20 is connected to fascia layer 18 by selectively placed adhesive. The gallbladder layer 20 may be formed of a number of pieces joined together, or it may be formed as a unit without discontinuities. To form the monolithic gallbladder layer 20, the manufacturing process involves dipping the wax mold into molten plastic and, once the plastic hardens, melting and dissolving it.
In one form, gallbladder model 10 is configured to practice bile duct trial incisions. In such a configuration, the biliary structures of the gallbladder layer 20 are hollow and filled with a fluid that mimics bile. An exemplary fluid is green colored dishwashing liquid. The hollow bile duct structure has an inner diameter of about 0.09 inches (2.286 mm) and an outer diameter of about 0.15 inches (3.81 mm). The gallbladder model 10 configured for bile duct trial incision has a hollow gallbladder 32 filled with a fluid that mimics bile. The free ends of cystic duct 34, common hepatic duct 36, and common bile duct 38 are closed or fitted with standard duct caps to retain fluid within these ducts so that no fluid is lost as simulated bile. , capped with solid or barbed connectors. If not molded as a single unit, biliary structures made of multiple tubular structures are connected together by connectors. For example, the junction of the common hepatic duct 36 and the common bile duct 38 is connected to a connector, such as a Y-split, that allows fluid to flow between them. In one form, the cystic duct 34 and the common bile duct 38 are connected by a connector or formed as a unitary structure so that fluid can flow between the cystic duct 34 and the common bile duct 38. The employment of connectors makes it possible, after a practice procedure to cut the cystic duct and common bile duct, for example in cholecystectomy, to replace the dissected duct with a new duct reconnected at the same location using the same connector, As a result, it is advantageous in that the training procedure can be carried out repeatedly. In the gallbladder model 10 configured for bile duct test incision, any one or more of the gallbladder 32, bile duct 34, common hepatic duct 36, and common bile duct 38 may contain one or more simulated gallstones ( (not shown). Simulated gallstones are small bead-like structures made of plastic or other materials. The simulated gallstones are placed within the hollow space of the gallbladder 32 and/or within the lumen of one or more of the cystic duct 34, the common hepatic duct 36, and the common bile duct 38. These simulated gallstones are invisible to the user when the model is accepted, but a simulated contrast fluid, e.g. colored water, is injected into one of these ducts using a syringe and/or catheter. or injected into two or more ducts and configured such that a continuous flow of contrast fluid is visually obstructed or obstructed by the gallstones when the simulated contrast fluid fills the biliary structures. ing. In another form, a kit is provided that includes a syringe and/or a simulated gallstone as a means for injecting fluid into the gallbladder 32. In another form, the gallbladder 32 is not filled with fluid and is filled with air, which can be injected into the open cavity of the gallbladder 32 using a syringe or other similar device. is good. The cavity of the gallbladder 32 is preferably pressurized to a pressure higher than ambient pressure, so that when the gallbladder 32 is inadvertently penetrated by improper surgical technique, the gallbladder 32 may become noticeably deflated. , thus providing a visual display to the trainee. In such a configuration, the gallbladder 32 has a wall thickness configured to allow observation of deflation of the gallbladder 32.
Still referring to FIG. 2, the peritoneal layer or fourth layer 22 is made of a thermoplastic elastomer or silicone that is transparent or partially translucent and/or dyed a light yellow color and has a thickness of approximately It is a thin layer of 0.01~0.03 inch (0.254~0.762 mm). The peritoneal layer 22 is substantially the same as the fascial layer 18 and has the same peaked shape as the underlying fascial layer 18 and liver layer 16. Peritoneal layer 22 has an inner and outer surface and covers gallbladder layer 20 and at least a portion of the inner surface of second layer 18. In one form, both the fascial layer 18 and the peritoneal layer 22 are each formed by molding liquid silicone onto a layer of foam, such as a layer of packaging foam or other cancellous structure, and then After the foam is cured, it is peeled away from the foam, thereby providing at least one textured surface to the fascial layer 18 and the peritoneal layer 22. Peritoneal layer 22 is sized and shaped to cover gallbladder layer 20. The peritoneal layer 22 is attached to the fascial layer 18 by an adhesive, the adhesive being positioned such that it can make direct contact with the fascial layer 18 without interference from the intervening gallbladder layer 20. . Therefore, only some portions of the peritoneal layer 22 are attached to the fascial layer 18; in one form, the peritoneal layer 22 is attached only to the fascial layer 18 and not to the gallbladder layer 20. In another form, portions of the peritoneal layer 22 are attached to the gallbladder layer 20 as well as portions of the fascial layer 18. In yet another form, some portions of the peritoneal layer 22 are attached only to some portions of the gallbladder layer 20. These layers are held together by adhesives or by the inherent tackiness of the materials that make up these layers. Essentially, the peritoneal layer 22 is selectively attached to one or more of the underlying gallbladder layer 20 and fascial layer 18 by adhesive.
Still referring to FIG. 2, the anatomical portion 12 has a frame 24, which includes a tabletop or other substantially organ-receiving tray or other surface located within the laparoscopic training simulator. The device is configured to support in a substantially upright orientation relative to a flat surface. Frame 24 has a left leg 48 and a right leg 50 interconnected by a central portion 52. The central portion 52 is curved and mimics the overall shape of a chevron with the other layers 16, 18, 22. Frame 24 is sized smaller than liver layer 16, fascial layer 18, and peritoneal layer 22. The frame 24 is made of a hard metal, plastic or other material that is capable of supporting the silicone and plastic layers that make up the anatomical portion 12 of the model 10 in an upright orientation and is sufficiently rigid to do so. Made of polymer or material. The left leg 48 is located at or adjacent to the peak and is approximately 3.5 to 4.0 inches (8.89 to 10.16 cm) in length; the shorter right leg 50 is approximately 2.5 inches in length. ~3.0 inches (6.35~7.62cm). The curved central portion 52 is approximately 4.0-4.5 inches (10.16-11.43 cm) long and follows the curvature of the layers 16, 18, 22. The total height of the gallbladder model 10 is approximately 5 to 6 inches (12.7 to 15.24 cm), and the length of the model 10 is approximately 5 to 6 inches (12.7 to 15.24 cm). Left leg 48 has a left prong 54 at its free end, and right leg 50 has a right prong 56 at its free end. Left prong 54 and right prong 56 extend beyond anatomical portion 12 for insertion into support 14. Frame 24 is substantially circular in cross section and approximately 0.15 inches (3.81 mm) in diameter, with prongs 54, 56 having a slightly larger diameter. Each prong 54,56 has a curved ball-shaped or spherical or chevron-shaped detent 58 as shown in FIG. 4, which is a cross-sectional view of the left leg 48. Prongs 54, 56 have chevron-shaped distal tips. Frame 24 is connected to anatomical portion 12 such that prongs 54, 56 protrude from the layer described above for connection with support 14. As mentioned above, in one form, the frame 24 is molded directly into the liver layer 16, and the frame is clear or transparent in color, or the frame is not easily visible to the user. has substantially the same color as the liver layer 16 in which the frame is embedded.
In another form, the frame 24 does not include ridges and is substantially U-shaped. As shown in FIG. 7, the central portion 52 of the frame 24 is straight and does not follow the shape of the peaks of the other layers 16, 18, 22. This configuration provides less support to the other layers 16, 18, 22 at the location of the peak 30, advantageously all of these layers being highly flexible and adjacent to the frame 24. The model 10 at the support 14 can be easily pushed distally or proximally with respect to the area where it is located, thereby practicing retraction of the liver 16 from the gallbladder 32, while the model 10 at the support 14 An overall supporting effect is still provided. In this configuration, both the right leg 50 and the left leg 48 are identical in length, approximately 2.5 to 3.0 inches (6.35 to 7.62 cm) long, rather than the left leg 48 being longer at the location of the crest 30. It is of length. The peaks 30 formed in layers 16, 18, and 22 represent only a portion of the liver, specifically the right lobe of the liver, and all of the anatomical structures of the gallbladder layer 20 are shown in model 10. ing.
Still referring to FIG. 5, support 14 is configured to couple to anatomical portion 12 to maintain anatomical portion 12 in a substantially upright orientation relative to a table top or other surface. . Support 14 has a base 60 interconnected to an upright portion 62. Upright portion 62 has at least two receptacles 64 sized and configured to receive prongs 54, 56 of frame 24. Upright portion 62 further includes a spring-loaded plunger 66 in communication with each receptacle 64. To connect the anatomical portion 12 to the support 14, prongs 54, 56 are inserted into the receptacle 64 of the support 14. The distal chevron tips of prongs 54,56 cam against the plunger 66 until such distal chevron tips snap into detents 58 provided on each prong 54,56. and thereby securely lock the anatomical portion 12 to the support 14. The anatomical portion 12 is removed by releasing the plunger 66 from each detent 58 or by pulling with a force such that the detents 58 cam against the plunger 66 to move the plunger 66 out of the way. It can be removed from the support 14. The anatomical portion 12 can be snapped into the support 14 or into a receptacle formed as a removable part of a large anatomical model, organ tray, or laparoscopic training instrument. Optional coupling engagement means for coupling the anatomical portion 12 to the support 14 includes left prongs 54 and right prongs 56 that split outwardly to fan out as shown in FIG. Within the scope of the present invention. The prongs 54, 56 are further biased outwardly and tilted so that in the deflected state they snap over and behind the detents, thereby holding the anatomical portion 12 in support. Fixed at 14. To remove the anatomical portion 12, the user squishes or squeezes the split ends of the prongs 54, 56 together under the support 14, allowing the prongs 54, 56 to slide past the detents. do it like this. Frame 24 and anatomical portion 12 are separated from support 14.
Using the gallbladder model 10, open procedures involving the gallbladder anatomy can be practiced. The gallbladder model 10 is also particularly suitable for practicing laparoscopic gallbladder procedures. For practicing laparoscopic gallbladder procedures, Model 10 is used as a laparoscopic training instrument 68, such as that shown in Figure 6 and filed on September 29, 2011 by Pravong et al. and published by Applied Medical. No. 13/248,449 (Title: Portable laparoscopic trainer), assigned to Applied Medical Resources Corporation and published as U.S. Patent Application Publication No. 2012/0082970. placed in the trained training equipment 68. In addition, this US patent application publication is cited by reference, and the entire content thereof is incorporated herein by reference.
Still referring to FIG. 6, the laparoscopic training instrument 68 has a top cover 70 connected to a base 72 by a pair of legs 74 separating the top cover 70 from the base 72. Laparoscopic training instrument 68 is configured to mimic the patient's torso, eg, abdominal region. The top cover 70 represents the front surface of the patient, and the space defined between the top cover 70 and the base 72 represents the interior or body cavity of the patient in which organs are housed. Laparoscopic training instrument 68 is a useful tool for teaching, practicing, and/or demonstrating various surgical procedures and their associated instruments in a simulated patient setting. A surgical instrument is inserted into the cavity through the pre-drilled hole 76 in the top cover 48. These pre-drilled holes 76 may have seals that mimic trocars or simulated tissue areas that mimic the patient's skin and abdominal wall portions. Various tools and methods can be used to penetrate the top cover 70 to perform full-scale procedures on a model organ, such as the gallbladder model 10, located between the top cover 70 and the base 72. be able to. Once placed within the cavity of the training instrument 68, the gallbladder model 10 is generally obscured from the user's view and the user can view the surgical site indirectly, in this case by means of a video feed displayed on a video monitor 78. By observing, you can practice performing the surgical technique laparoscopically. A video display monitor 78 is hinged to top cover 70 and is shown in an open orientation in FIG. Video monitor 78 can be coupled to various vision systems to send images to monitor 78. For example, a laparoscope inserted through one of the preformed holes 76 or a webcam provided within the cavity and used to complete the simulated procedure can be viewed on a video monitor 78 and/or a mobile computing device. It is better to connect the image to the user and provide the image to the user.
When assembled, top cover 70 is positioned directly above base 72 with legs 76 disposed substantially around the periphery and interconnected between top cover 70 and base 72. Top cover 70 and base 72 are of substantially the same shape and size and have substantially the same peripheral contour. Laparoscopic training instrument 68 has a top cover 70 angled relative to base 72. The legs 52 are configured so that the angle of the top cover 70 relative to the base 72 can be adjusted. FIG. 6 shows the training device 68 adjusted to an angle of about 30-45 degrees relative to the base 72. The selected tilt angle of the top cover 70 is locked by tightening the thumbscrews provided in the legs 74. Such an angle of inclination of the top cover 70 of the training device 68 relative to the base 72 is particularly advantageous with respect to receiving the gallbladder model 10 of the present invention.
With top cover 70 tilted as shown in FIG. 6, gallbladder model 10 is inserted into the cavity of training instrument 68 and positioned between top cover 70 and base 72. With the gallbladder model 10 inserted into the training device 68, the peritoneal layer 20 faces the front of the training device 68. Specifically, the inner surface of the gallbladder model 10 substantially faces the pore or tissue simulating region 76. Top cover 70 is tilted such that top cover 70 is positioned between the user and gallbladder model 10. The direction of access by the user is through the hole or simulated tissue 76 provided in the top cover 70. The top cover 70 is inserted into these locations 76 to access the gallbladder model 10 and thereby practice the surgical procedure. A scope is also inserted through one of the holes 76 into the training instrument cavity between the top cover 70 and the base 72 to capture video images of the hidden gallbladder model 10 and display these on a video monitor 78. displayed to the user.
A user practicing laparoscopic cholecystectomy approaches the gallbladder model 10 within the training instrument 68 by passing the scope and other instruments into the cavity of the laparoscopic training instrument 68. Model 10 advantageously depicts or mimics the gallbladder in a retracted state so that the user does not have to retract the simulated liver using surgical graspers to maintain the retracted position. There is no need for an assistant to hold one or more of the graspers. Unlike this, the Gallbladder Model 10 is designed to be used by one person.
In practicing laparoscopic cholecystectomy, the user practices identifying Calot's triangle by observing images on monitor 78 using the inserted scope. After identifying Caret's triangle, the peritoneal layer 22 is incised and the cystic duct 34 and cystic artery 40 are accessed. Advantageously, only selected portions of the peritoneal layer 22 are attached to the underlying layer 18 or layers 18, 20, so that the cystic duct 34 and cystic artery 40 can be easily skeletonized or separated from the peritoneal layer 22. do. Also, because some portions of the cystic duct 34 and cystic artery 40, as well as other elements of the gallbladder layer 20, are selectively attached to the underlying layers, they are advantageously attached to their anatomical They maintain their layout and are still relatively mobile as they would be in vivo. The mobility of elements including the gallbladder layer 20 relative to the liver layer 16 or one or more adjacent fascial or peritoneal layers 18,22 is advantageous if such layers 18,22 are simply present within the model 10. as well as by selectively attaching such gallbladder layer elements to one or more of the fascial layer 18 and the peritoneal layer 22, as well as to the underlying hepatic layer 16. This is enhanced by the mobility of the underlying fascial layer 18 that is attached. Selective adhesion of one layer to an adjacent layer requires application of adhesive to pre-selected areas and strategic positioning of anatomical structures requiring significant mobility and/or removal relative to adjacent layers. This is obtained due to the fact that no adhesive is provided in these areas. Regarding the gallbladder 32, the gallbladder 32 is attached to a fascia layer 18 located above the liver layer 16. This allows the gallbladder 32 to be removed from the model 10 without any damage to the liver layer 16 or only slight damage to the liver layer 16, both of which are practical consequences of this procedure. The liver is a highly vascular and sensitive structure, and removing the gallbladder without too much attention to the liver is critical to the success of a cholecystectomy, and Model 10 allows for an advantageous practice. It is possible to achieve such results in Although the fascia layer 18 does not exist in reality, the fascia layer aids in the simulation. This is because without the fascia layer 18, the adhesive cannot be dissected in the same way as the actual connective tissue between the gallbladder and the liver. In one form, the outer surface of the peritoneal layer 22 is attached to the gallbladder layer 20 with an adhesive. In the same configuration, the peritoneal layer 22 is also adhesively attached to the inner surface of the second layer 18 only along at least a portion of its periphery. Also, in the same configuration, the outer surface of the second layer 18 is glued to the inner surface of the liver layer 16 only along at least part of its periphery. As a result of this configuration, pulling the peritoneal layer 22 results in the gallbladder layer 20 being pulled together with the peritoneal layer 22, so that the peritoneal layer 22 and the gallbladder layer 20 are pulled together with the peritoneal layer 22 and the liver layer 16. The combination forms a tent. This is because the peritoneal layer 22 is only circumferentially attached to the second layer 18 and the second layer 18 is only circumferentially attached to the hepatic layer 16, thereby providing an effective tenting. This is because it is possible to obtain the effect of In a variation of this configuration, the gallbladder 32 is attached to the inner surface of the second layer 30. Pulling the gallbladder layer 20 and/or the peritoneal layer 22 and/or the gallbladder 32 in a direction substantially perpendicular to the layers 16, 18, 22 or away from the liver layer 16 results in the second layer 18 It becomes more tented relative to the liver layer 16 where the gallbladder 32 is present. Because the layers 18, 22 are extensible and selectively attached as described above, tenting of the layers 18, 20, 22 can easily occur. Therefore, as the peritoneal layer 22 is pulled away from the liver layer 16, as a result of a predetermined number of selected clings, the peritoneal layer 22 tents between the peritoneal layer 22 and the fascial layer 18. A first gap or pocket is formed. Also, because the fascial layer 18 tents against the liver layer 16 when the fascial layer 18 is pulled due to the predetermined and selective attachment of the gallbladder 32 to the second layer 18, A second gap or pocket is formed between the fascial layer 18 and the liver layer 16. In this case, the second gap or pocket is smaller than the first gap or pocket when the peritoneal layer 22 is pulled away from the liver layer 16. The second layer 18 is also preferably made slightly thicker than the peritoneal layer 22. Peritoneal layer 22 and second layer 18 are thicker than liver layer 16.
Prior to removal of the gallbladder 32, the user introduces a surgical clip applier through one of the holes 76 of the training instrument 68 and secures the clip to both the cystic duct 34 and the cystic artery 40 in two locations. practice. Vascular and biliary structures can be flexible, inciseable, and have the ability to function similarly to human anatomical structures, while also allowing the vascular and bile duct structures to function similarly to human anatomical structures. It is made of a material that can withstand the application, so that when the clip is closed against the structures of the gallbladder layer 20, the clip will not cut through these structures. The user then inserts laparoscopic scissors through one of the holes 76 and cuts the cystic duct 34 and cystic artery 40 between the two locations of the clip. The gallbladder 32 is then separated from the bed of the liver and removed through one of the trocars inserted into one of the holes 76. Gallbladder 32 is advantageously attached to fascial layer 18 and not directly attached to liver layer 16. The presence of the fascial layer 18 makes the removal of the gallbladder 32 realistic as described above, thereby providing a location for the incision.
Gallbladder model 10 is also useful for training residents and surgeons in laparoscopic common bile duct exploratory incisions. Common bile duct exploratory dissection is a procedure used to determine whether gallstones or some other obstruction are blocking the flow of bile from the gallbladder or liver to the intestines. In practicing this procedure, the gallbladder model 10 is placed within the cavity of the laparoscopic training instrument 68 with the scope inserted into one of the holes 76 of the laparoscopic training instrument 68 and the resulting live With the image displayed on video monitor 78, the abdominal cavity is approached as in the cholecystectomy described above. The user identifies the common bile duct 38 on the monitor 78. A bladed instrument is introduced into the cavity of the training instrument 68 and a small semicircumferential incision is made in the common bile duct 38. A cholangiography catheter (not shown) is inserted into the cavity of the laparoscopic training instrument 68 through one of the holes 76 and an AEROSTAT® manufactured by Applied Medical Resources Corporation, California. and inserted into the incision made in the common bile duct 38. Instead of a contrast agent or radiopaque fluid, colored water is injected into the distal end of the catheter by a syringe and allowed to flow into the cystic duct 34 and the common bile duct 38. The colored water fills one or more bile duct structures, thereby allowing simulated gallstones to be seen. Therefore, during training for bile duct trial incisions, fluoroscopy is not required to identify the presence of gallstones in training procedures using the gallbladder model 10 of the present invention. When gallstones are present, the obstruction appears as a discontinuity in the flow of colored water. The user can then practice locating the simulated gallstones at the locations of fluid flow obstructions or color discontinuities. Once the simulated gallstones are located, the user practices removing such gallstones from the hollow bile duct structure.
The invention further includes a kit for practicing common bile duct trial dissection. The kit for common bile duct trial dissection includes a gallbladder model 10 and a syringe of colored water. The kit further includes a catheter and/or a plurality of simulated gallstones that can be inserted into the biliary structures of the gallbladder layer 20. The kit may further include replacement portions for any one or more of the tubes 34, 36, 38 and arteries 40, 42, 44, 46 and/or connectors. The replacement tube has a hollow lumen for practicing common bile duct test incisions. Other replacement tubes and/or arteries included in the kit are solid diameter structures for replacing previously severed tubes and/or arteries during the practice of a previous procedure.
Although the gallbladder model 10 of the present invention is particularly suited for laparoscopic procedures, the invention is not so limited and the gallbladder model of the present invention can be equally effectively utilized in open surgical procedures.
It goes without saying that various modifications to the embodiments of the gallbladder model 10 disclosed herein can be made. Therefore, the above description should not be construed as limiting the invention, but merely as exemplifications of preferred embodiments. Those skilled in the art will recognize other modifications that are within the scope and spirit of the invention.
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Every citation, both ways
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| WO96042076A1 | Cites | World Intellectual Property Organization (WIPO) |
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| 201361836512 | United States of America | P | |
| 2019043506 | Japan | A | |
| 2021063936 | Japan | A |
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| JP2016523383A | Japan | A | |
| EP3011550B1 | European Patent Office (EPO) | B1 | |
| US9922579B2 | United States of America | B2 | |
| ES2661644T3 | Spain | T3 | |
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| AU2014281483B2 | Australia | B2 | |
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| EP4648036A2 | European Patent Office (EPO) | A2 | |
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Numbers
- Publication
- 7470751
- Application
- 143052
Titles2
- Japanese
- 外科的処置を教示すると共に練習するための胆嚢モデル
- English
- Gallbladder model for teaching and practicing surgical procedures
Classification
- CPC, 3
- G09B23/34
- G09B23/30
- G09B23/32
- IPC, 4
- G09B23 30
- G09B23 34
- G09B9 00
- G09B19 00
