EP1018957A1 - Dispositif et procede facilitant l'acces a un conduit du corps humain - Google Patents

Dispositif et procede facilitant l'acces a un conduit du corps humain

Info

Publication number
EP1018957A1
EP1018957A1 EP98950886A EP98950886A EP1018957A1 EP 1018957 A1 EP1018957 A1 EP 1018957A1 EP 98950886 A EP98950886 A EP 98950886A EP 98950886 A EP98950886 A EP 98950886A EP 1018957 A1 EP1018957 A1 EP 1018957A1
Authority
EP
European Patent Office
Prior art keywords
catheter
lumen
cutting
sphincterotome
proximal end
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP98950886A
Other languages
German (de)
English (en)
Inventor
Jozef Slanda
James Charles Yearick
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boston Scientific Ltd Barbados
Original Assignee
Boston Scientific Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Boston Scientific Corp filed Critical Boston Scientific Corp
Publication of EP1018957A1 publication Critical patent/EP1018957A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22072—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22072—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other
    • A61B2017/22074—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other the instrument being only slidable in a channel, e.g. advancing optical fibre through a channel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00553—Sphincter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1407—Loop

Definitions

  • the present invention relates generally to the field of surgery, and more particularly to an improved device and method for facilitating access to a duct within the human body.
  • a person may experience a gallbladder attack when gallstones form in the gallbladder and become too large to pass through the cystic duct and the common bile duct and into the duodenum. Such an attack can cause intense pain and may require that the person's gallbladder be surgically removed.
  • a physician may use a less traumatic procedure to cut the sphincter sufficiently to permit even large size gallstones to pass into the duodenum. This procedure is referred to as "ERS,” or "endoscopic retrograde sphincterotomy.”
  • a physician When performing ERS, a physician introduces a side- viewing endoscope through the patient's esophagus, into the stomach, through the pyloric sphincter, and into the duodenum. «Next, the physician positions the endoscope near the papilla of Vater and then threads a catheter through the endoscope, through the sphincter of Oddi, and into the bile duct. At this point, the physician may inject a radio-opaque contrast fluid through the catheter and into the patient. By using contrast fluid, the physician may view any gallstones fluoroscopically and evaluate their size.
  • a physician may determine that the sphincter of Oddi needs to be enlarged even before the physician can properly cannulate and visualize the bile duct. Also, a physician may determine that there is no need to visualize the obstruction with contrast fluid and may instead just decide to enlarge the sphincter of Oddi so that the obstruction may pass through the sphincter of Oddi and into the duodenum.
  • the first is to use an electrosurgical sphincterotome to cut the papilla of Vater of the sphincter of Oddi partially open.
  • the second is to use an electrosurgical needle knife to perform the same function.
  • Electrosurgical sphincterotomes are well known.
  • An electrosurgical sphincterotome has a cutting wire that extends the length of the catheter and forms a cutter outside of the catheter. The proximal end of the cutting wire is in electrical communication with an external power source.
  • the physician energizes the cutting wire and manipulates the sphincterotome cutter to cut the targeted tissue.
  • the second method is by thermal radiation; the temperature of the cutter is increased by electrical resistance, and thermal energy from the cutter is transferred to the targeted tissue when the cutter approaches the tissue.
  • Electrosurgical needle knives are similarly well known.
  • An electrosurgical needle knife has a cutting wire that extends the length of the catheter and forms a cutting wire tip outside of the catheter. The proximal end of the cutting wire is in electrical communication with an external power source.
  • the physician energizes the cutting wire and manipulates the cutting wire tip to cut the targeted tissue.
  • the cutting wire tip also cuts the targeted tissue through either electrical arcing or thermal radiation.
  • R/F radio frequency
  • the “Ultratome XL” contains an electrosurgical sphincterotome, and the second and third lumens are used respectively for a guide wire and contrast fluid.
  • the "Ultratome XL,” however, does not include a needle knife. The merits of performing a needle knife sphincterotomy as opposed to a standard endoscopic sphincterotome sphincterotomy have been widely discussed in the medical art.
  • the needle knife procedure is seen as an alternative technique for gaining access to the bile duct when the standard method of sphincterotome sphincterotomy fails to provide the physician with access.
  • the physician When switching from sphincterotome sphincterotomy to needle knife sphincterotomy, however, the physician must first remove the sphincterotome from the patient and then insert a needle knife. Switching instruments, however, wastes valuable time during a procedure and will require the physician to expend additional time repositioning the new instrument at the desired location.
  • a physician who is using multiple-lumen instruments in conjunction with a guide wire may be able to switch instruments without having to reposition the guide wire, there still is a delay while the sphincterotome is first removed and the needle knife is inserted.
  • needle knife sphincterotomy is generally seen as an alternative approach to be used when standard sphincterotome sphincterotomy is unsuccessful, some physicians prefer to use both instruments routinely when attempting to gain access to the bile duct. With the current state of the medical art, however, these physicians must remove one instrument entirely before they are able to use the other. Therefore it would be desirable to provide an instrument that is a combination of a sphincterotome and a needle knife for use in performing a sphincterotomy.
  • the device includes a ulti- lumen catheter having a sphincterotome cutting wire disposed through a first lumen and attached at its proximal end to a sphincterotome deployer, and a needle knife cutting wire disposed through a second lumen and attached at its proximal end to a needle knife deployer.
  • a method for performing combined sphincterotome and needle knife sphincterotomy is also provided wherein it is no longer necessary to remove one of the two instruments from the endoscope before the other instrument can be used.
  • Pig. 1 is a perspective view of the preferred embodiment of the present invention
  • Fig. 2 is a partially cross-sectional view of the preferred embodiment of the present invention, showing the needle knife in its fully-deployed position
  • Fig. 2A is a cross-sectional view of the three- lumen catheter used in the preferred embodiment of the present invention.
  • Fig. 2B is a cross-sectional view of a four-lumen catheter that may be used in the present invention.
  • Fig. 3 is an enlarged detailed viewed of the working end of the present invention as shown in Fig. 2;
  • Fig. 4 is a partially cross-sectional view of the preferred embodiment of the present invention, showing the needle knife in its fully-retracted position;
  • Fig. 5 is an enlarged detailed view of the working end of the present invention as shown in Fig. 4;
  • Fig. 6 is an enlarged detailed sectional view of the deployer end of the needle knife used in the preferred embodiment of the invention.
  • Fig. 7 is an enlarged detailed sectional view of the deployer end of the sphincterotome used in the preferred embodiment of the invention.
  • Fig. 8 illustrates an endoscope near the point of introduction into the common bile duct
  • the present invention comprises a needle knife 1, a sphincterotome 4, and a multi-lumen catheter 7.
  • the needle knife 1 is attached to the catheter 7 at an injection port 10 by a luer lock 13, while the sphincterotome 4 is attached to the catheter 7 by heat shrink material 16.
  • both the needle knife 1 and the sphincterotome 4 are fixedly attached to the catheter 7.
  • the needle knife 1 may be removably attached to the catheter 7 so that fluid (such as radio- opaque contrast fluid) or another instrument may be disposed through the injection port 10 when the needle knife 1 is not attached to the catheter 7.
  • the catheter 7 has a substantially cylindrical shape and a substantially uniform diameter.
  • the catheter 7 is specifically designed and sized to be introduced into a duct or body passage of a patient through the accessory channel 6 of a standard endoscope 5 (as seen in Fig. 9) .
  • the catheter 7 used in the preferred embodiment of the invention is preferably made of Teflon® to facilitate its easy insertion into the body, and has a length sufficient to extend the length of a standard accessory channel 6 and to reach sufficiently into the duct or passage.
  • the preferred working length of the catheter 7 i.e., the length of the catheter 7 excluding the proximal portion that does not enter the endoscope 5 for use on an adult patient is approximately between 190 and 205 centimeters. As seen in Fig.
  • the catheter 7 narrows near its distal tip 22 and forms a working end 23.
  • the working end 23 is that portion of the catheter 7 that is designed to exit the endoscope 5 and enter the duct or body passage of the patient.
  • the length of the working end 23 for use on an adult patient is approximately between six and nine centimeters.
  • the catheter 7 has three lumens 7a, 7b, and 7c (shown in Fig. 2A) extending lengthwise therethrough.
  • the first lumen 7a is for receiving a cutting wire 28 of the sphincterotome 4
  • the second lumen 7b is for receiving a cutting wire 41 of the needle knife 1
  • the third lumen 7c is for receiving a guide wire 201.
  • Additional lumen (such as fourth lumen 7d shown in Fig. 2B) may also be provided for carrying contrast fluid, saline solution, additional instruments, or other items or fluids that a physician may wish to introduce into the patient during a given procedure.
  • both the second and third lumens of the catheter 7 exit the catheter 7 at its distal tip 22 in a generally distal direction.
  • the first lumen does not exit the catheter 7 at its distal tip 22 , but rather near the distal tip 22 through a cutting wire port 25.
  • This arrangement is well known in the art and allows the sphincterotome cutting wire 28 to exit the catheter 7 through the cutting wire port 25 and thereby become a cutter 31.
  • the cutter 31 is bowed between a first location 37 and a second location 38 on the outside of the catheter 7.
  • the cutter 31 re-enters the catheter 7 and, preferably, the first lumen, through an anchor port 34 and is anchored within the catheter 7 as is well known.
  • Fig. 3 and Fig. 5
  • the cutter 31 straightens out (and the catheter 7 flexes) when the cutter 31 is used to incise tissue (as shown in Fig. 10) .
  • Figs. 2 and 4 Detailed depictions of the proximal and distal ends of the present invention are provided in Figs. 2 and 4, wherein a substantial portion of the length of the catheter 7 has been redacted to facilitate the illustration of the present invention.
  • the proximal end of the third lumen terminates at a guide wire port 19.
  • the guide wire 201 is preferably fed into and out of the third lumen of the catheter 7 by hand, although using a guide wire feed device (not shown) , such the guide wire feed device disclosed in United States Patent No. 5,599,300 by Weaver et al. , is also well known.
  • the guide wire feed device may be attached to the guide wire port 19.
  • the guide wire 201 has a diameter of approximately .035 inches and is coated with a hydrophilic coating to facilitates its easy insertion and removal through the catheter 7.
  • the needle knife 1 is fixedly attached to catheter 7 at the injection port 10 by the luer lock 13.
  • the needle knife 1 may be attached to catheter 7 with heat shrink material (not shown) .
  • the sphincterotome 4 may be fixedly or releasably attached to the catheter 7 with a luer lock or other fastener.
  • the needle knife cutting wire 41 extends longitudinally from the needle knife 1, through the second lumen, and, in its fully- deployed position, exits the distal tip 22 of the catheter 7 to form a needle knife cutting tip 44. In its fully-deployed position, it is preferable that the needle knife cutting tip 44 extend approximately ten millimeters beyond the distal tip 22 of the catheter 7 when the catheter 7 is in a straight configuration.
  • Fig. 6 depicts the internal structure of the deployer end of the needle knife 1 used in the preferred embodiment of the invention.
  • the two main parts of needle knife 1 are the needle knife cutting wire 41 and the needle knife cutting wire deployer 2.
  • the needle knife cutting wire deployer 2 used in the preferred embodiment of the invention is principally comprised of a body 61 and a piston 62 that slidably engages the body 61.
  • a luer lock 13 is provided at the distal end of the body 61 for attaching the body 61 to the injection port 10.
  • a thumb ring 63 is attached to the proximal end of the piston 62, and a finger grip 73 covers the proximal end of the body 61.
  • the user of the needle knife 1 is able to manipulate the position of the piston 62 relative to the body 61.
  • the piston 62 is free to move longitudinally within the body 61 between a fully-retracted position and a fully-deployed position.
  • the body 61 defines a slot 75 through which a first socket set screw 71 extends from the piston 62.
  • a banana plug assembly 77 is attached to the first socket set screw 71, and therefore the banana plug assembly 77 is attached to the piston 62.
  • the banana plug assembly 77 is comprised of a banana plug 69 and a banana plug sheath 65, and the banana plug 69 is used for making an electrical connection to a power source (not shown) to provide a cutting/coagulating current to the needle knife cutting wire 41, as is well known in the art.
  • the proximal end of the needle knife cutting wire 41 is disposed longitudinally through the body 61 and the piston 62, and is fixedly attached to the piston 62 by the first socket set screw 71 and a second socket set screw 72, both preferably made of stainless steel, and a conductive disc 76, preferably made of aluminum.
  • the majority of the needle knife cutting wire 41 is disposed through the second lumen of the catheter 7 and extends longitudinally to the distal tip 22 of the catheter 7.
  • the needle knife cutting wire 41 exits the distal tip 22 of the catheter 7 and forms a needle knife cutting tip 44 that extends approximately ten millimeters beyond the distal tip 22 of the catheter 7 when the catheter 7 is in a straight configuration.
  • the needle knife cutting tip 44 When the needle knife 1 is in its fully- retracted position, the needle knife cutting tip 44 remains entirely within the second lumen of the catheter 7 and does not exit the distal tip 22 of the catheter 7.
  • the first socket set screw 71 is used to connect the banana plug assembly 77 to the piston 62, and the needle knife cutting wire 41 is attached to the first socket set screw 71, the needle knife cutting wire 41 is therefore fixedly connected to the banana plug assembly 77.
  • the first socket set screw 71 and the conductive disc 76 are preferably made of a conductive material, such as stainless steel and aluminum respectively, the needle knife cutting wire 41 is also electrically connected to the banana plug 69 of the banana plug assembly 77.
  • the user of the needle knife 1 is free to move the piston 62 longitudinally within the body 61 by applying the necessary force to the thumb ring 63 relative to the finger grip 73.
  • the user By sliding the thumb ring 63 toward the finger grip 73, the user deploys the needle knife cutting wire 41 through the distal tip 22 of the catheter 7.
  • the thumb ring 63 away from the finger grip 73 the user retracts the needle knife cutting wire 41 and the needle knife cutting tip 44 into the second lumen within the distal tip 22 of the catheter 7.
  • An 0-ring 80 is provided to help ensure that any movement of the piston 62 with respect to the body 61 is smooth and continuous when a given force is applied to the thumb ring 63.
  • the range of motion of the piston 62 relative to the body 61 is between a fully-deployed position and a fully-retracted position.
  • the first socket set screw 71 which extends through the slot 75 of the body 61, likewise moves relative to the body 61.
  • the slot 75 extends from a first position 78 (proximal on the body 61) to a second position 79 (distal on the body 61) .
  • the element that comes in contact with the body 61 at either the first position 78 or second position 79 is the first socket set screw 71. It is recognized, however, that a component of the banana plug assembly 77, such as the banana plug sheath 65, may be relied on to restrict the movement of the piston 62 relative to the body 61, or other means may be provided to limit the motion of the piston 62 relative to the body 61.
  • the cutting wire 41 of the needle knife 1 has a diameter of approximately .01 inches and is made from stainless steel.
  • the two main parts of the sphincterotome 4 are the sphincterotome cutting wire 28 and the sphincterotome cutting wire deployer 3.
  • the sphincterotome cutting wire deployer 3 used in the preferred embodiment of the invention is principally comprised of a fixed member 90 and a sliding body 87, which surrounds and slidably engages the fixed member 90.
  • a thumb ring 93 is attached to the proximal end of the fixed member 90, and fingers grips 96 are integrally connected to the sliding body 87.
  • the user of the sphincterotome 4 is able to manipulate the position of the sliding body 87 relative to the fixed member 90.
  • the sliding body 87 is free to move longitudinally over the fixed member 90 between a fully-retracted position and a fully-deployed position.
  • a banana plug assembly 99 is attached to the sliding body 87 by a first socket set screw 225 and a fastener 215.
  • the first socket set screw 225 passes through the fixed member 90 through a slot (not shown) .
  • the banana plug assembly 99 is comprised of a banana plug 220 and a banana plug sheath 230.
  • the banana plug 220 is used for making an electrical connection to a power source (not shown) to provide a cutting/coagulating current to the sphincterotome cutting wire 28, as is well known in the art.
  • the sphincterotome cutting wire 28 is disposed longitudinally through the sliding body 87 and the fixed member 90.
  • the sphincterotome cutting wire 28 also passes through side holes (not shown) of an insert 70, which snugly engages the sliding body 87 and is open at one end 300.
  • a second socket set screw 235 is contained within the insert 70, which is threaded to receive and fixedly attach screws 225 and 235 to the insert 70. Accordingly, a portion of the sphincterotome cutting wire 28 is sandwiched between the second socket set screw 235 on one side, and a conductive disc 240 and the first socket set screw 225 on the other side.
  • the first socket set screw 235 extends through the opening at the end 300 of the insert 70 and is attached to the banana plug assembly 99 by the fastener 215. As the insert 70 is snugly engaged with the sliding body 87 and the socket set screws 225 and 235 are fixedly attached to the insert 70, both socket set screws 225 and 235 and the conductive disc 240 are likewise fixedly attached to the sliding body 87.
  • the socket set screws 225 and 235 are preferably made of stainless steel, and the conductive disc 240 is preferably made of aluminum.
  • the sphincterotome cutting wire 28 is fixedly attached to the second socket set screw 235 and the conductive disc 240, the sphincterotome cutting wire 28 is also fixedly attached to the sliding body 87 and to the banana plug assembly 99. Furthermore, as the first socket set screw 225 and the conductive disc 240 are preferably made of conductive materials, such as stainless steel and aluminum respectively, the sphincterotome cutting wire 28 is also electrically connected to the banana plug 220 of the banana plug assembly 99.
  • the majority of the sphincterotome cutting wire 28 is disposed through the first lumen of catheter 7 and extends longitudinally to the distal tip 22 of catheter 7. As seen in Fig. 3, the first lumen exits the catheter 7 near its distal tip 22 through a cutting wire port 25.
  • This arrangement is well known in the art and allows the sphincterotome cutting wire 28 to exit the catheter 7 through the cutting wire port 25 and thereby become the cutter 31.
  • the cutter 31 is "bowed" between a first location 37 and a second location 38 on the outside of catheter 7. The cutter 31 re-enters the catheter 7 and, preferably, the first lumen, through the anchor port 34 and is anchored within the catheter 7 as is well known.
  • the distal tip 22 of the catheter 7 remains in a generally longitudinal alignment.
  • the cutter 31 will pull tight and deform the distal tip 22 of the catheter 7 from its generally longitudinal alignment (as seen in Fig. 10) .
  • a physician may use the cutter 31 of the sphincterotome 4 in any position ranging from its fully-retracted position to its fully-deployed position.
  • the user of the sphincterotome 4 is free to move the sliding body 87 longitudinally over the fixed member 90 by applying the necessary force to the finger grips 96 relative to the thumb ring 93.
  • the user By sliding the finger grips 96 away from the thumb ring 93, the user reduces the tension on the sphincterotome cutting wire 28, thereby allowing the distal tip 22 of the catheter 7 to return to a generally longitudinal alignment.
  • the finger grips 96 toward the thumb ring 93 the user applies tension to the sphincterotome cutting wire 28 and the cutter 31 will pull tight and deform the distal tip 22 of the catheter 7 from its generally longitudinal alignment.
  • the range of motion of the sliding body 87 relative to the fixed member 90 is between a fully-deployed position and a fully-retracted position.
  • the sliding body 87 comes in contact with the fixed member 90 at a first position 206 and is restricted from moving further in a proximal direction. This point, therefore, defines the fully-retracted position of the sphincterotome 4.
  • the sliding body 87 comes in contact with the fixed member 90 at a second position 207, it is restricted from moving further in the distal direction. This point, therefore, defines the fully-deployed position of the sphincterotome 4.
  • the sphincterotome cutting wire 28 and the cutter 31 are all formed from a single strand of stainless steel wire having a diameter of approximately .01 inches.
  • the physician can insert the catheter 7 into the common bile duct 108 with little effort.
  • the physician can then cannulate and visualize the area by injecting contrast fluid through a fourth lumen of the catheter 7 , through a lumen of the needle knife 1 (if the needle knife 1 is hollow and has a lumen) , or through either the first, second, or third lumen if the physician removes the sphincterotome 4, the needle knife 1, or the guide wire 201 from the catheter 7.
  • the physician may also perform additional surgical procedures, such as the introduction and removal of stents, or may use an additional instrument, such as a biopsy cutter, stone extractor, forcep, or the like, through a fourth lumen of the catheter 7 or through either the first, second, or third lumen if the physician removes the sphincterotome 4, the needle knife 1, or the guide wire 201 from the catheter 7.
  • an additional instrument such as a biopsy cutter, stone extractor, forcep, or the like
  • the physician may forgo the use of a guide wire 201 altogether and use the third lumen (and possibly a fourth lumen) for either injecting contrast fluid or for an additional instrument.
  • the physician introduces a side- viewing endoscope 5 through the patient's esophagus, into the stomach, through the pyloric sphincter, and into the duodenum 101.
  • the physician positions the endoscope 5 near the sphincter of Oddi 104 in the papilla of Vater 107.
  • the endoscope 5 is positioned to allow the physician to view the sphincter of Oddi 104 as is known.
  • the physician may advance a guide wire (not shown) through the accessory channel 6 of the endoscope 5 and position the guide wire at the point near the sphincter of Oddi where the physician desires to place the catheter 7.
  • the catheter 7 is then threaded over the guide wire through the third lumen of the catheter 7 and is positioned near the sphincter of Oddi 104.
  • the physician advances the catheter 7 into engagement with the sphincter of Oddi 104 by inserting the distal tip 22 into the ampulla of Vater, which communicates with the common bile duct 108 and the pancreatic duct 109.
  • the physician selects to perform either a sphincterotome sphincterotomy, a needle knife sphincterotomy, or a combination of the two.
  • Fig. 10 shows a sphincterotome sphincterotomy being performed on a patient's sphincter of Oddi 104.
  • the physician orients the cutter 31 of the sphincterotome 4 so that the cutter 31 and the catheter 7 are oriented radially with respect to the central ampulla of Vater.
  • the cutter be oriented to the 12 o'clock position of the papillary orifice to avoid injury to the duodenal wall or pancreatic duct 109.
  • the physician then energizes the sphincterotome cutting wire 28 and the cutter 31, manipulates the position of the cutter 31 by using the elevator and/or positioning controls of the endoscope 5 and/or by using the sphincterotome cutting wire deployer 3, and cuts the sphincter of Oddi 104 radially outward of the center of the sphincter of Oddi 104.
  • the physician controls the amount of "bow" in the cutter 31 by manipulating the sliding body 87 of the sphincterotome 4 relative to the fixed member 90 as explained previously.
  • the physician When performing a needle knife sphincterotomy, the physician advances the thumb ring 63 of the needle knife 1 toward the body 61, thereby deploying the needle knife cutting tip 44 through the distal tip 22 of the catheter 7 to its proper length.
  • the physician then energizes the needle knife cutting wire 41 through the banana plug 69, manipulates the position of the needle knife cutting tip 44 by using the elevator and/or positioning controls of the endoscope 5 and/or by using the needle knife cutting wire deployer 2 , and incises the targeted tissue.
  • the physician retracts the needle knife cutting tip 44 into the second lumen of the catheter 7 by withdrawing the thumb ring 63 away from the body 61 of the needle knife 1.
  • the physician may elect to perform a sphincterotome sphincterotomy.
  • the physician after performing either a sphincterotome sphincterotomy, a needle knife sphincterotomy, or a combination of both forms of sphincterotomies, can now insert the catheter 7 into the common bile duct 108 with little effort.
  • the physician can then cannulate and visualize the area by injecting contrast fluid through a fourth lumen or through either the first, second, or third lumen if the physician removes the sphincterotome 4, the needle knife 1, or the guide wire 201 from the catheter ⁇ 7.
  • the physician may also perform additional surgical procedures, such as the introduction and removal of stents, or may use an additional instrument, such as a biopsy cutter, stone extractor, forcep, or the like, through a fourth lumen or through either the first, second, or third lumen if the physician removes the sphincterotome 4 , the needle knife 1, or the guide wire 201 from the catheter 7.
  • additional instrument such as a biopsy cutter, stone extractor, forcep, or the like
  • the physician may remove the catheter 7 and thread a new catheter, capable of carrying contrast fluid and/or one or more additional instruments, into the common bile duct 108 or any other duct or body passage.
  • a new catheter capable of carrying contrast fluid and/or one or more additional instruments
  • the physician may remove the catheter 7 of the present invention over the guide wire 201 and thread the new catheter over the still properly-positioned (or subsequently repositioned) guide wire 201 and into the desired location within the duct or body passage.

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  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif et un procédé améliorés facilitant l'accès à un conduit du corps humain. Ledit dispositif comprend un cathéter à plusieurs lumières dont un fil coupant de sphinctérotome est disposé dans une première lumière et fixé par son extrémité proximale à un dispositif de déploiement du sphinctérotome, et dont un fil coupant de lame-aiguille est disposé à l'intérieur d'une seconde lumière et fixé par son extrémité proximale à un dispositif de déploiement d'une lame-aiguille. En utilisant ce dispositif, un médecin peut réaliser une sphinctérotomie endoscopique classique et une sphinctérotomie à lame-aiguille sans avoir à changer d'instruments par l'endoscope. Ainsi, il a plus facilement et plus efficacement accès à un conduit du corps humain. L'invention concerne également un procédé permettant de réaliser une sphinctérotomie combinée à sphinctérotome et à lame-aiguille pour laquelle il n'est plus nécessaire de retirer de l'endoscope l'un des deux instruments avant de pouvoir utiliser l'autre instrument.
EP98950886A 1997-10-03 1998-10-02 Dispositif et procede facilitant l'acces a un conduit du corps humain Withdrawn EP1018957A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US943339 1986-12-17
US94333997A 1997-10-03 1997-10-03
PCT/US1998/020827 WO1999017669A1 (fr) 1997-10-03 1998-10-02 Dispositif et procede facilitant l'acces a un conduit du corps humain

Publications (1)

Publication Number Publication Date
EP1018957A1 true EP1018957A1 (fr) 2000-07-19

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EP98950886A Withdrawn EP1018957A1 (fr) 1997-10-03 1998-10-02 Dispositif et procede facilitant l'acces a un conduit du corps humain

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Country Link
EP (1) EP1018957A1 (fr)
JP (1) JP2001522617A (fr)
AU (1) AU9681198A (fr)
WO (1) WO1999017669A1 (fr)

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JP4841788B2 (ja) 2000-02-04 2011-12-21 コンメド エンドスコピック テクノロジーズ インコーポレイテッド ３管腔結石バルーン・カテーテルおよびその方法
US6695834B2 (en) 2002-01-25 2004-02-24 Scimed Life Systems, Inc. Apparatus and method for stone removal from a body
EP1572263A4 (fr) 2002-11-01 2008-10-29 Conmed Endoscopic Technologies Catheter a embout conique, court, a profil bas
WO2008048814A2 (fr) * 2006-10-17 2008-04-24 Wilson-Cook Medical Inc. Aiguille d'aspiration guidée par fil
CN104023647B (zh) * 2012-07-13 2017-12-08 奥林巴斯株式会社 内窥镜用处理系统
DE102015114538A1 (de) * 2015-08-31 2017-03-02 Eberhard Karls Universität Tübingen Medizinische Fakultät Mehrlumenkatheter zur Durchführung endoskopischer Interventionen
WO2019241572A1 (fr) * 2018-06-13 2019-12-19 Endoscopytools, Llc Outils endoscopiques à pointe souple et procédé
KR102353604B1 (ko) * 2020-02-28 2022-01-21 주식회사 파인메딕스 하이브리드 괄약근 절개기

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JPS6031690Y2 (ja) * 1981-12-11 1985-09-21 株式会社 メドス研究所 内視鏡用高周波切開器
DE8711635U1 (fr) * 1987-08-27 1988-01-21 Gip Gastrointestinale Produkte Vertriebs Gmbh, 8221 Grabenstaett, De
US5024617A (en) 1989-03-03 1991-06-18 Wilson-Cook Medical, Inc. Sphincterotomy method and device having controlled bending and orientation
US5536248A (en) 1992-05-11 1996-07-16 Arrow Precision Products, Inc. Method and apparatus for electrosurgically obtaining access to the biliary tree and placing a stent therein
US5843028A (en) * 1992-05-11 1998-12-01 Medical Innovations Corporation Multi-lumen endoscopic catheter
EP0593741B2 (fr) 1992-05-11 2004-10-27 Medical Innovations Corporation Catheter biliaire perfectionne
US5599300A (en) 1992-05-11 1997-02-04 Arrow Precision Products, Inc. Method for electrosurgically obtaining access to the biliary tree with an adjustably positionable needle-knife
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Also Published As

Publication number Publication date
AU9681198A (en) 1999-04-27
WO1999017669A1 (fr) 1999-04-15
JP2001522617A (ja) 2001-11-20

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