JP2007533400A5 - - Google Patents

Description

System and method for introducing multiple medical devices

  The present invention relates to catheters that are inserted into a medical device, more precisely, a wire guide and inserted into a patient.

  This application is a continuation-in-part of US Provisional Patent Application No. 10,901,561 filed on July 29, 2004, and the non-provisional patent application is a US Provisional Patent Application filed on May 13, 2004. Claiming priority to Application No. 60 / 570,656, No. 60 / 563,968, filed Apr. 21, 2004, and No. 60 / 491,408, filed Jul. 31, 2003. Yes.

  Since the first use of the Seldinger method in the late 1950s and 1960s, minimally invasive treatments, i.e. making it easier to introduce or place catheters and other medical devices using wire guides, blood vessels, tubes or organs Access to the Internet has actually been developed. An important advance has gained the ability to replace a medical device by extrapolating to a single wire guide placed in the body without having to replace the wire during the procedure and without losing access to the target site That is. This “over the wire (OTW)” exchange technique requires an extra long guide wire so that control can be maintained over the wire at all times during the procedure. To accomplish this, the portion of the wire that extends out of the patient's body can be kept in the longitudinal position of the proximal portion of the wire at all times by an assistant, usually behind the physician. Thus, it must be at least as long as the device. For example, an endoscopic catheter used for accessing the bile duct system is usually 200 cm or more in length, and in order to be placed in the bile duct during replacement, the length of the wire guide is 400 cm or more (for example, 480 cm) is required. When the catheter is extrapolated from the wire and removed, the physician and assistant need to perform a series of careful actions between the exchange wire and the device. The assistant pushes the wire out as long as the doctor pulls back the catheter until the device is completely out of the patient and the doctor can control the wire at the port of the endoscope. The assistant then pulls the device out of the wire and extrapolates the second device over the wire and sends it back into the patient for the second procedure, which includes a similar push-pull in the opposite direction. Technique is required. This procedure requires a skilled assistant on behalf of the physician who is actually responsible for the advancement of the wire. In the bile duct ERCP, the technique used depends largely on the good oral communication between the doctor and assistant and the latter experience, so without this wire guide control, it is inconvenient when intubating into a large orifice.

  The “long wire” or OTW technique is still widely used as a method of replacing devices in the bile duct system, but a much shorter wire guide and a technique that allows doctors to control the wire more quickly have been developed. Has been. This method, known under various designations as “rapid exchange”, “monorail” or “short wire”, is not a device that is inserted extrapolated over the entire length of the wire guide, but rather the length of the catheter device. It differs from the OTW technique in that it is only partially connected. The device is extrapolated to the wire guide. Here, the wire guide passes through a port or channel formed inside the catheter that is located at a point between the distal end and the proximal portion of the catheter, usually within the distal portion of the device. Or exit the connecting part of the catheter. This allows the physician to control the proximal or external portion of the wire as the wire exits the patient or from the endoscope, reducing the need to move the device in sync with the assistant. Once the connecting part exits the patient (or the endoscope in the case of gastroenterology or other endoscopic procedures), the physician (for gallbladder procedures) is sufficient from the sterile zone to assist the replacement with an assistant. Short replacement (instead of conventional long wire replacement, which is required to stand by). In certain other devices, the catheter is cracked or split to disconnect from the wire as it exits the patient. When inserting the device, the connecting portion of the catheter is advanced over the proximal end of the wire guide and the physician carefully keeps the wire in place so that the distal end of the wire is maintained within the treatment site and Ensure that access is not lost.

  Rapid exchange or short wire techniques have proven particularly desirable in coronary and vascular surgeries, which allows a series of procedures using multiple catheter-based devices to be performed with only one wire. For example, a stent is installed following angioplasty. Another example where short wire exchange techniques are often used is in endoscopic procedures performed in the pancreatic gallbladder system. In general, ERCP (endoscopic retrograde cholangiopancreatography) treatment introduces the catheter device through the duodenoscope through a large orifice (Fatel papilla) into the bile duct system including the bile duct, pancreatic duct and liver hepatic duct Is done. Usually, an intubation device with a sphincter / papillotomy or ECRP catheter is inserted into the bile duct system and the first procedure is performed, but this procedure is actually a diagnostic, such as injection of contrast media. Or a treatment aimed at therapy such as enlarging a large orifice. If a second medical procedure is required, such as removing a calculus, opening a stenosis, or collecting tissue, a second device such as a balloon, basket, snare, biopsy brush, dilator, stent delivery catheter, or the like The device is inserted over the original wire guide and subjected to a secondary therapeutic procedure.

  Although the OTW technique has allowed device replacement, the development of the short wire technique has been accepted by physicians who prefer to maintain high control of the wire guide in the endoscope. A well-known example of this rapid exchange technique is a device with a MICROVASIVE RX BILARY STST ™ (Boston Scientific Corporation, Natwick, Mass.), Where the catheter portion of the device also depends on the device Includes an internal lumen that extends between a distal opening and a proximal opening that are 5 cm to 30 cm apart, and thus the 260 cm long JAGWIIRE® guidewire developed for this system When removing the device by extrapolation, replacement for the length is required. An example of a sphincter in this system (AUTOTOME ™ intubated sphincter) is shown in FIG. The lumen extends proximally from the proximal opening to form a “C-shaped channel” (shown in FIG. 2), which when the catheter portion is introduced into the endoscope Holds the wire guide in the catheter and when the catheter is removed from the endoscope, the wire is withdrawn laterally from the channel, allowing the wire to access the biopsy port of the endoscope (FIG. 3), and the second Catheter type devices (eg, balloons, baskets, stent delivery catheters, etc.) can be extrapolated to the proximal end of the wire for subsequent delivery. When the distal portion of the first device exits the endoscope, the short replacement (doctor and assistant) until the physician gains control of the wire and the assistant can withdraw the first device without fear of losing access. (Synchronized push-pull movement between) is required, which is actually similar to that used in OTW processing. The proximal end of the wire guide is usually secured to the endoscope for the most part during the procedure to avoid losing access, but is removed from the endoscope to allow catheter replacement and removal. It must be.

  The Microvasive system offers modest time savings and provides more control of the wire by the physician and reduces the reliance on assistant skills to assist in performing the exchange, but in short exchange procedures, especially the catheter Care must be taken not to lose access to the tube because the wire guide cannot be secured to the endoscope during removal. Because the wire guide is in the catheter channel and the connected device is constrained together in the accessory channel, the connection must be released when the distal portion of the catheter exits the proximal end of the endoscope . This process is more time consuming due to the frictional resistance between the wire and the catheter, so this is the point when the device is extrapolated to the lumen in the catheter or the C-shaped channel in the next exchange process and fed or removed. It becomes a problem.

  Extending the C-channel along the catheter can cause clinical disadvantages. For example, a catheter breach is an entry point for blood or bile, a well-known source of viruses and bacteria, into the lumen of the catheter, where the blood or bile moves to the proximal end of the device, where it often leaks. Get out and stick to the floor and clothes of people involved in this procedure. The channel is also a potential air leak point, which can jeopardize the ability to maintain a proper blow in the duodenum during processing. Another disadvantage of the C-type channel is that it degrades the quality of the catheter, which is an intubation device (such as a deflected sphincter) that can be used to straighten the access path to the tube. This can be a problem when trying to insert or “lift”, or when inserting a stenosis.

  Current rapid exchange or short wire systems have also not solved some of the disadvantages found in conventional OTW methods. For example, if a plurality of plastic drainage stents are placed side by side, the delivery system must be removed and the wire must be disconnected, necessitating re-intubation of the nipple. Furthermore, in existing devices, the catheter that also functions as a conduit must be removed from the patient and treatment site before having an empty lumen for the second wire, such as when placing a stent in multiple tubes. Does not provide the ability to place the second wire next. Another drawback of current systems for exchanging gallbladder devices is the incompatibility between the two systems. The long wire device does not have a side access port for use with a short exchange wire, and the MICROVASIVE RX BILARY SYSTEM (TM) device with a C-type channel is not well-made for long-wire exchange. Is broken during the first exchange process, it is difficult to introduce the long wire through the proximal wire guide access port (including the open channel) and keep it from slipping out of the channel upon introduction. Also, C-channels are generally not compatible with small diameter wire guides (less than 0.035 inches) for the same reasons. The incompatibility between systems means that not all possible options are available when a physician selects the best device and treatment for a particular patient.

  What is needed is an improved short wire for exchanging devices in an efficient and reliable manner within a surgical site that is compatible with the long wire exchange method and addresses the above disadvantages. Systems and techniques.

  In the illustrated system and method for introducing and replacing a plurality of elongated medical devices, eg, tubular members, such as catheters, with a guide member introduced into the body, such as a wire guide in a patient body (lumens, Within the treatment site (defined as the path to which a tube, organ, vessel, other body passage or cavity, or wire guide / guide member access is maintained during a particular procedure or series of procedures) The first device (primary access device) is disconnected from the guide member by remote control, thereby making it easy to remove the device and replacing the device outside the patient's body so that the secondary access device can be introduced into the body. The above problem is solved by a system and method for introducing and exchanging medical devices by simplifying the introduction by extrapolating the wire to the outside. It is achieved. The main focus of this application is to replace the device in either the pancreatic bile duct system or the gastrointestinal tract, but the present system and method for remotely disconnecting the device within the treatment site Any appropriate technique for exchanging the device by extrapolating to the guide member introduced into the body can be applied to any part. Examples include, but are not limited to, balloons, stents, grafts, occluders, filters, distal protection devices, catheters for ablation, phototherapy, brachytherapy, prosthetic valves, or others This is the case of introducing and placing an instrument or device to be inserted into a vascular system including the coronary artery, the peripheral arterial system (eg, carotid artery or renal artery) or the venous system (eg, deep veins of the leg). Other representative sites include the reproductive-urinary system (eg, bladder, ureter, kidney, fallopian tube, etc.), and bronchial system. The system and method also replaces the device in a body cavity, for example, in the peritoneum, pleural cavity, pseudocyst or true cyst structure, via percutaneous placement or replacement with a needle, trocar, or sheath. Can be used in case.

  The basic system of the device for remotely disconnecting comprises a guide member, typically a wire guide. In addition, after that, the term “wire guide” as used herein is a generic meaning of any device configured to perform the above function (eg, small diameter catheter, laser fiber, string, plastic). Bead, stylet, needle, etc.) that is not technically regarded as a wire guide (or “guide wire”) as a term commonly used in the medical arts Should also be understood to include such devices. Remote disconnection allows the use of a shorter guide / wire guide than that used for other short wire methods (eg, quick change), and hence the method described hereinbelow. Are generically referred to as “ultra-short wire” techniques, or “intravascular replacement (IDE)”, “intravascular replacement (IVE)”, etc., depending on the treatment site. The reason why the length of the wire guide can be made shorter than that of the conventional quick exchange wire guide is that the exchange is not performed outside the patient's body. In fact, remote disconnection allows the replacement wire guide to be shorter than the device being introduced because the device is not removed on the wire. For example, in the case of a Microvasive “rapid exchange” procedure, an external exchange of 5 to 30 cm must be performed each time, depending on the device used, whereas the commonly used wire guide is 260 cm, whereas the gallbladder device The wire guide (used for a 145 cm channel duodenoscope) of the present invention is typically 185 cm (minimum functional length of about 180 cm). The shorter the wire, the easier it is for a single practitioner to operate and it also helps prevent contact with non-sterile surfaces such as the floor, patient bed, instrument table, imaging device, and the like. If the length is 185 cm, most external exchanges can be performed if necessary. Also, to accommodate long wires for exchanging devices that are not compatible with the system, an optional coupling mechanism is provided at the proximal end of the wire and the wire guide extension is engaged so that the length of the wire Can be extended (e.g., to 260 cm or 480 cm) to perform a conventional exchange scheme.

  Connected to the guide member / wire guide is a first elongate medical device (primary access device), typically a tubular member or catheter device, which may be a passage or lumen, or an external channel, outer ring, or There is a connection area around the distal portion, such as another interface area, which is configured to receive a portion of the wire guide, while both the wire guide and the medical device are in operation within the treatment site. A portion of the wire guide is received so that a releasable connection pair can be constructed. The connecting region may be part of an elongate medical device or may be centered about another element (e.g., an elongate engagement member) disposed therewith, but this other element is also a book. For use in applications only, it is considered a component of an elongated medical device. Another elongate engagement member may provide a primary or secondary means for releasably securing the wire guide and catheter device until they are repositioned or disconnected. The elongate engagement member is typically, but not necessarily, disposed within the passage of the tubular member, and the engagement member can further include a connection region. The primary access device used with the system (not an open or split channel) so that the system can be easily converted to introduce a long wire if a long wire compatible device is selected. It is desirable to have a closed or self-sealing passage that extends to the proximal (external) portion of the device. In addition, the device of the present invention is configured to return to wire extrapolation when conventional short wire replacement is desired or remote disconnection is difficult (due to unexpected anatomical constraints). ing.

  In a first aspect of the invention, the apparatus includes an alignment marker system, such as a marker system (eg, radiopaque marker, external marking, endoscopic marking, etc.), a wire guide and / or a first Centered on an elongated medical device, the distal end or distal portion of the wire guide is at the proximal end of a connection region such as a side access port or aperture (eg, an aperture) through which the wire exits. It is possible to use it when arranging it. Conveniently, this alignment marker system allows control by the physician when the two devices are connected or disconnected within the surgical site and assists in confirming the disconnection. Without such confirmation, it is highly likely that the physician will attempt to disconnect the catheter and wire guide (eg, under fluoroscopy guidance) without knowing when the disconnection has occurred or is about to occur. Can be difficult. Depending on the location of the body or treatment site and the device being delivered, attempting to disconnect the device “without sight” can cause loss of wire guide access, especially if the device remains engaged while the wire guide remains engaged. If it is pulled out prematurely, this can happen. Also, the relative amount of movement between the device and the wire guide that is necessary to ensure that the disconnection has occurred is generally much larger than when using the display, so the wire guide is pulled far away. There is an increased risk of losing access too much, or insufficient space for releasing the connection within the treatment site. Typical quick change devices are not configured with the necessary radiation or other suitable indications because the replacement procedure is intended to take place outside the patient. External exchange is a slow process, in which the first catheter or wire guide is extrapolated to an existing device (which is always a wire guide or guide device in conventional rapid exchange) and advanced to the treatment site before the first Removal of the catheter is directed.

  A first series of embodiments of the present marking system is suitable for determining the alignment and engagement between the primary or secondary access device and the guidance device by using an appropriate external guidance system (fluoroscopy, MRI, CT scan). Radiographic or ultrasonically reflective markings provided on one or more devices used by the practitioner under (X-ray, ultrasound, etc.). The first embodiment comprises a wire guide and a radiopaque or dense band, marking, etc. provided at the distal end of the first elongate medical device. In particular, the distal tip of the wire guide typically has a radiopaque portion comprising at least the length of the connecting region of the first elongate medical device, the portion being iridium, platinum Or a radiopaque marker, such as a band containing other suitable material, located around the proximal end of the connecting region (eg, at the side access port or just distal thereof) This allows the practitioner to know when the distal tip of the wire is approaching or exits the point of the catheter where the device is disconnected or disconnected within the treatment site. In addition, other radiopaque markers are used for placement of radiopaque markers or stents or balloons that are not commonly used to assist remote disconnection, such as at the distal end of a catheter. A sign may be provided.

  A second series of embodiments of the system representation comprises a directly visible indicator disposed near the proximal portion of the wire guide and a tubular member to which it is coupled during the procedure. In certain embodiments, the wire guide includes a visually identifiable alignment point, which is between one marker (eg, a color band) or a different color and / or pattern area of the wire guide outer coating. A transition point is shown that the wire guide and the distal end of the tubular member are aligned with each other when aligned with a predetermined first marking on the proximal portion of the elongated medical device. The catheter further includes a second mark representing a disengagement point, when this aligns with a predetermined alignment marking on the wire guide, the two devices are either being connected or disengaged or have already been disengaged, It is shown that the distal tip of the wire guide is out of the connection region. The first (distal) and second (proximal) markings on the proximal portion of the catheter are in a region that remains outside the patient or endoscope during the procedure and are separated by the same distance as the length of the connecting region. It is desirable to be arranged. If the connection area is very short (eg, a ring), it is desirable that one mark on the catheter indicate disengagement if a proximal indicator is used.

  A third series of embodiments of the marking system includes a marking configured to be visible with a fiber optic endoscope or video endoscope (eg, a duodenoscope, a gastroscope, a bronchoscope, a ureteroscope, etc.). In devices configured to access the pancreatic gallbladder system, the marker comprises a marking provided in the middle portion of each of the wire guide and the elongated medical device, and during normal procedures, a viewing lens or endoscope It can be aligned using a video monitor (or viewing port) that is distal to the video chip and proximal to the orifice bulge and confirms that disconnection has occurred in the tube. The device may include other endoscopic markers useful during remote disconnection procedures. For example, gallbladder catheters are provided with a depth marking at a predetermined distance (eg, 10 cm) from the catheter tip to indicate that IDE can be safely performed in the tube without the risk of losing wire guide access when implanted in the nipple. Also good. The distal portion of the wire guide should be conspicuous as a visible cue to warn the physician whether the tip of the wire guide is completely pulled out of the tube and there is a risk of re-intubation of the nipple. (For example, black). Advantageously, the second and third labeling systems do not require an external imaging process, allowing the physician to limit the time that the patient is exposed to fluoroscopy. For example, when performing a procedure while using at least one of the other types of signs as an alignment guide at another location, fluoroscopy can be used only at selected critical times.

  In addition to using visual indications to confirm whether the wire guide and the first elongate medical device (and the next device) are engaged or disconnected, the present invention provides for the device as it moves relative to each other. One or more ridges and / or depressions that allow the physician to “touch” or feel the point at which disengagement occurs or is about to occur due to discontinuous points between the devices Other types of alignment display systems are included, such as one or more devices or haptic systems including along an accessory channel port of an endoscope. Magnets can also be a component of a haptic system. Other embodiments of the alignment indicator system include a sensor based system in which the sensor is located. A sensor located along the catheter or endoscope channel / port senses any calibration position in the system (eg, wire guide or catheter) and sends a signal or cue (eg, electrical signal) or Provided and communicated in the form of an audible or visual alarm that alerts the practitioner that the device has been disconnected or is being connected. The alignment system may comprise one system or means for alignment, or may comprise a combination of visual and non-visual indicators.

  In a second aspect of the invention, a method (i.e., a basic) for disconnecting a first elongate medical device from a wire guide while both the first elongate medical device and the wire guide are at the treatment site. An ultra-short wire technique) is provided. The two devices use a standard introducer method such as an endoscope, introducer sheath and introducer member, with the wire guide engaged through the connecting region of the introduced medical device, and the surgical site. To be introduced. In certain embodiments used for the pancreatic gallbladder system, the connecting region comprises a passage in the distal portion of the catheter, eg, the distal 6 cm portion, and the wire guide is connected to the side access port (eg, ), And along the outside of the proximal portion of the catheter, both the wire guide and the catheter extend so that they extend together in line along the introduction path. In the embodiment, it becomes a channel of a duodenoscope. For example, a 4a wire guide or primary access device such as a sphincter, needle knife, ERCP catheter, etc. can be first introduced into the tube for duct intubation, and then the primary access device is extrapolated to the wire. Advance and perform a first medical procedure such as diagnosis and / or therapy. During this time, the wire guide is suitably fixed in place by attaching the proximal portion to the endoscope via a locking device, clip, or other means located near the wire guide inlet port (biopsy port) Thus, the position is fixed in the longitudinal direction to assist in maintaining access to the treatment site. Once the first device has performed the desired action (contrast injection, sphincter resection, etc.), the practitioner provides an x-ray that provides visual guidance while repositioning the device, an endoscope, and The disengagement can be performed preferably using a proximal display system or the like. One technique (herein referred to as “device IDE”) involves extrapolating the primary access device over the stationary guidewire until the connection is released. A second technique (referred to herein as “wire guide IDE”) includes withdrawing the wire guide while keeping the primary access device in a stationary position until the alignment indication indicates that disconnection has occurred. Yes. The third technique is a compromise between the device IDE and the wire guide IDE. In addition, the radiopaque wire guide tip typically exhibits a characteristic “whipping” action as it exits the passage, which is visible under fluoroscopy, This operation check is also a unique sign that can be seen when the connection is released.

  When the physician uses at least one component of the alignment indicator system to determine that the distal end of the wire guide has been disengaged from the connection area of the primary access device, the first device can receive the endoscope attached channel ( Alternatively, for applications other than blood vessels or some other type of endoscope, it can be removed simply by pulling back from the introducer sheath. If there is a wire in the channel or lumen, there will be friction between the wire guide and the catheter, but this will be easier to remove. Some of the previously described MICROVASIVE RX ™ biliary devices (eg, AUTOTOME ™ sphincterotomy) have a side port at the distal portion, but any device can be remotely or intravascularly There is a lack of display combinations that make the exchange clinically practical, or even display combinations that allow it. Also, in a device with an open channel extending proximally of the side access port, the proximal portion of the wire guide “looks for the channel” when the device and the wire guide are both in the accessory channel of the endoscope. “Because there is a tendency to re-enter, it cannot be disconnected in the tube or in the treatment site, regardless of the presence or absence of the indication. Thus, remote disconnection is not possible without some means for releasably disengaging the wire from the channel.

  When the catheter and wire guide are uncoupled, the proximal end of the wire is extrapolated to a third elongate medical device (eg, a secondary access device or a second device that is the same as the first) and the treatment site Can be used to move forward. In one embodiment of the method, the proximal end of the wire introduced into the body is fed through the distal opening and out of the side access port of the secondary device and advanced to the treatment site. After the second medical procedure is performed using the secondary device, if another secondary device is required for another procedure, the first secondary device (tertiary medical device) is connected to the wire guide and Removed from the patient's body, the wire guide can be used to provide access for the quaternary device in the same manner as for the first two devices.

  In one variation of the method, the primary access device may be used for the second wire guide after disconnecting from the wire guide, such as in a procedure for intubating into a bifurcated tube or blood vessel. As an introduction route or a conduit, it may be placed at a predetermined position of the treatment site. An example of such a procedure may be the placement of a stent in two tubes that drain from separate liver lobes. The second wire guide is typically introduced through the proximal wire guide port or hub of the first device in communication with the passage, typically near the handle portion. This technique usually requires long wire replacement of the catheter. A second option is to introduce the wire through a proximal side access port (eg, an aperture) formed through the wall of the tubular member so that full control of the wire can be maintained. In this embodiment, the catheter wall is configured to break between the proximal access port and the side access port, or the wire guide is directed distally of the device so that no long exchange is required. It contains open or self-sealing channels that can be exposed. To remove or expose the wire guide laterally from the passageway, use isotropic catheter wall material (eg PTFE) that can be broken or structurally weakened into the catheter wall. A material that can incorporate a sealable seam or locking seam along the wall of the catheter, or that thin the wall or when sufficient force is applied, the wire guide breaks the wall to form its own exit path Any known means such as use may be used. Alternatively, a wire guide that includes a connecting region such as an attached sleeve may be used to connect to a standard wire guide already introduced into the body, or both wire guides may be joined together. It may be coupled and advanced through the passage of the elongated tubular member.

  After gaining access to the passageway with one of the above means, the wire guide is guided under external imaging methods such as fluoroscopy and enters the desired location. Optionally, if the first device is a sphincterotome or other type of deflectable catheter, the practitioner can place the tip of the second wire guide on the opposite (or lateral) side of the tube or blood vessel. To assist in guiding into the branch, the shape and orientation of the catheter tip can be manipulated. Orientation within the treatment site is facilitated by orienting the tip with a rotatable handle. Also, with some short short wire guides such as the 185 cm gallbladder wire guide illustrated in the present invention, a practitioner can often achieve similar results simply by turning the wire with his finger. It has been demonstrated that the rotational force of can be transmitted.

  In another aspect of the invention, the primary access device is an elongate engagement member configured to releasably engage a wire guide in or near the coupling region (eg, a distal passage of the tubular member). Is further included. Embodiments include a flexible wire stopper (eg, a nylon stylet) that is configured to wedge the wire guide within the passageway when in a fully advanced position, and snare the wire guide. Using a thread-like member (e.g., a suture) that provides tension to maintain the tube member in a fixed position longitudinally relative to the tubular member. If an elongated engagement member is not used at the time of introduction, for example when the secondary access device is introduced by extrapolation into a wire guide already introduced into the body, a reinforcing stylet is optionally provided in the passage of the tubular member. It may be maintained to increase the rigidity of the device being introduced and / or to traverse the opening of a tubular member, such as a side access port, to prevent twisting.

  In yet another aspect of the present invention, the remote decoupler system or ultrashort wire technique uses a plastic tubular drainage stent delivery catheter and a single intubation procedure to place multiple stents in the bile duct. Includes placement techniques that allow them to be lined up. The entire system, including the wire during the procedure, disengages the wire guide by placing the side access port on the inner delivery member (to which the stent is attached by extrapolation) at a point distal to the stent. The stent can be placed without the need to pull out. The joint between the inner delivery member and the wire guide is advantageously used to “catch” the stent when the inner member is pulled back, thus allowing the entire delivery system, including the stent, to be pulled back in the tube. ing. This mechanism is not present in other delivery systems, but is particularly important in dealing with situations where the stent is advanced too far into the tube and repositioning is required. When the stent is correctly positioned, the inner delivery member is advanced and / or the wire guide is withdrawn, the two devices are disconnected, and the second stent delivery catheter (and additional stent) is advanced into the tube. The inner delivery member can then be pulled through the stent and from the tube, leaving behind the wire guide to be placed alongside the first stent. Porcine tail stents, and other stents that include a molded distal portion for heel wear, can be temporarily straightened by a wire guide that traverses the connecting region during delivery.

  In yet another aspect of the present invention, the wire guide is engaged within the endoscope channel and around the distal end of the endoscope or attached to the endoscope (or coexisting with the endoscope). Using an endoscope and guide wire transport mechanism engaged along the wire guide, the wire guide can be placed by pulling or feeding it down through the patient's mouth. A treatment site, such as a gastroesophageal (GE) junction, is visualized and the distance to the patient's mouth is measured using tick marks on the proximal portion of the endoscope. The wire guide remains connected to the wire guide delivery mechanism and is advanced a known distance (eg, 10 cm) beyond the treatment site into the stomach where the connection is released following the procedure. The wire guide includes a fiducial mark at a known fiducial point (eg, a 10 cm point) relative to the treatment site, such as a GE junction. The proximal portion of the wire guide may be a different colored band or a spacing (eg, 5 cm) with different numbers or types of marks (usually using non-numerical markings) indicating a specific distance to the reference mark at the GE junction It is preferable to include a scale mark. To place and guide the primary access device to the desired treatment site, such as a GE junction, with the wire guide in place, the practitioner is placed proximal to the primary access device, such as a dilator, PDT balloon, achalasia balloon, etc. The device is advanced while aligning the markings on the part with the corresponding markings on the wire guide. If a secondary access device, such as a larger dilator, is needed, the first device is extrapolated into the wire and advanced into the stomach to release the connection, and the next device that is extrapolated to the wire is sent to the wire. To be available. Endoscopes have the advantage of ensuring the operability of the endoscope within the patient by transporting the wire outside the endoscope and proceeding to a treatment site that can also include the jejunum or other gastroesophageal system sites Means are preferably provided for positioning the device larger than the accessory channel of the mirror.

  Embodiments of the present invention will be described below as an example with reference to the accompanying drawings.

  By remotely uncoupling the first medical device from the wire guide within the patient without using a long wire or standard short wire replacement procedure, the series of medical devices can be extrapolated to the wire guide and into the patient. Illustrative systems and methods for implementation are shown in FIGS. A first exemplary embodiment of the system is shown in FIGS. 4 and 5, which system is shown in the illustrated tubular member 77 or GLO-TIP II® E.E. R. C. P. A first elongate medical device 10, such as a catheter that includes features similar to a catheter (Wilson-Cook Medical Ink), which includes a first distal end 75 (facing the distal end of the device). A second proximal end 76 and a standard diameter exchange wire guide 11 (eg, METRO® wire guide; Wilson-Cook Medical Inc.) or first elongate medical device 10. And an interconnecting region 14 having an interconnecting passage 31 sized and configured to receive other guide devices suitable for. The connection region 14 is generally located around the distal portion 13 of the tubular member 77 (first elongate medical device 10) and coincides with the distal portion of the main passage 27 (as shown). It may be, or it may be different. The distal portion 13 of the first elongate medical device and the distal portion 60 of the wire guide are engaged by the former with the latter via the connecting region 14, but the medical procedure and subsequent uncoupling of both devices are performed. While it is, it is usually defined as each part arranged in the treatment site. In the present disclosure, a surgical site is a hole, tube, organ, blood vessel, other body passage / body cavity, or a route leading to it, with wire guide access to perform a specific medical procedure / surgery or series of procedures. Defined as the place to be maintained. For example, in procedures involving the bile duct system, the site of treatment is considered the common bile duct, including the pancreatic duct and ducts extending into the liver lobe.

  The connection region allows the first elongate medical device 10 to be introduced together (sequentially or together) to the treatment site while being extrapolated and connected to the wire guide. When the wire guide 11 and the tubular member exit the patient body or endoscope, the proximal portion 59 of the wire guide exits the passage and out of the tubular member 77. Yes. This makes it easier for the physician to control the wire, similar to conventional short wire replacement or quick replacement. The first end 75 of the coupling region 14 shown in FIGS. 4 and 5 includes a distal opening 19 in the tubular member 77, and the second end 76 crosses the sidewall of the tubular member 77 and the tubular member. There is a side access port 15 or aperture located approximately 6 cm from the distal end 12. The illustrated connection region 14 is disposed in the distal portion 13 of the first elongate medical device 10 with a connection region passage 31 comprising the distal portion of the main wire guide passage 27. The range of the length of the connection region 14, ie the distance between the side access port 15 (or second end 76) of the elongate member 10 and the distal end 12, is determined by the disconnection point being remotely connected within the treatment site. As long as it is as close to the distal end of the device as possible, it may vary according to the device and application. The distance of 6 cm prevents inadvertent disconnection while meeting the anatomical constraints of the tube, in many cases ensuring sufficient room for the relative movement required for disconnection. It has been determined that this is a convenient connection region length for many biliary devices of the present invention in that it provides a sufficient length.

  When applied to the biliary system, the range of the connecting region length may be between less than 1 cm (eg a ring) and at least 15 cm. A more preferred length range for most devices is about 3 cm to 10 cm, with an optimum range of about 5 cm to 7 cm. For devices for the pancreatic duct, the ideal distance from the side access port 15 to the distal end 12 is 2 to 5 cm when the available distance is short. In addition, for devices intended for use in tighter body cavities, a side access port 15 must be placed very adjacent to or exactly at the tip 12 of the device to achieve a successful exchange. There is. On the other hand, for procedures where losing wire guide access is not a significant problem, such as certain vascular procedures, and when working with long passages, such as the intestine, side access ports 15 and connecting regions 14 are provided. There are many more options for the location.

  The illustrated side access port 15 is provided with a semi-circular opening (usually in cross-sectional view, or oval when viewed from above) having a normal catheter width of about 1/4 to 1/3, but with a wire Any opening may be used as long as the guide passage is dimensioned or shaped. One or several wires, sheaths, bands, blades, or at least within the peripheral region of the wire guide exit port (side access port) that cross, adhere to, embed, or reinforce the tubular member It may be advantageous to reinforce the area of the side access port 15 by other means to prevent kinking at that location. The wire guide 11 extends proximally from the distal opening 19 of the first device 10 and exits the passageway 31 and the connecting region 14 proximally through the side access port 15, The proximal end of the wire can be accessed and manipulated, locked, or otherwise secured during the procedure as needed. As described above, the distance of the coupling region 14 is relatively short, which is advantageous for moving the coupling devices relative to each other to disengage or decouple from each other. This may either advance the catheter 10 toward the distal tip 25 of the fixed wire guide 11 or pull the wire guide back until the wire guide is withdrawn from the catheter and exits the side access port 15 / connection region 14; Or it can be done by combining the advancement of the catheter and the withdrawal of the wire guide, both of which stay in the treatment site (eg, a tube) and facilitate access to the next device extrapolated to the wire in the body. It is preferable in the mode of doing.

  In the present invention, since no external exchange is required, to determine the length of the wire guide 11, the farthest point for advancing the distal portion 60 to the treatment site (e.g., for decoupling); An intermediate portion 97 extending from the treatment site to the outside of the patient or endoscope, and a proximal portion extending from the length sufficient for the operator to perform operations such as fixing the wire guide in place 59 (FIG. 7) need only be taken into account. In the illustrated bile duct embodiment, the length of the wire guide 11 is 185 cm to provide a minimal and proper extension from the accessory channel of the endoscope, but shorter for other procedures. Or a long length may be required. The length of the wire guide 11 need only be long enough to operate, lock or lock in place, but if necessary (remote disengagement is impossible or reasonable for some reason) If an appropriately shaped device has to be used (such as if not present), the dimensions of the proximal portion 59 should preferably be suitable for conventional short wire replacement techniques. The dimensions of the wire guide 11 are preferably slidable and releasable with minimal friction in the coupling area, but the catheter (or an auxiliary device extending with the wire) from a particular point releases the wire. Possible engagement and fixation mechanisms are considered part of this invention. The connecting region 14 of FIG. 5 comprises the distal portion of the passage 27 (passage 31), with the proximal portion 28 of the passage being a continuous portion of the lumen extending proximally from the side access port 15 point. Yes. Instead, the proximal passage 28 is not continuous to the proximal passage, but just proximal to the side access port 15 (with a movable flap or a permanent obstruction such as a plastic or metal insert). It may be at least partially blocked or restricted to act as a guide or ramp that helps the wire guide loaded from the distal opening 19 to easily exit the side access port. A blocking means (not shown) may also help limit fluid or other material from flowing back through the passage. In a related embodiment, the wire guide passage 27 extends only to the side access port 15 in the proximal direction and ends there.

  The illustrated connecting region 14 of FIGS. 4 and 5 is a wire guide 11 extending from the distal opening 19 of the tubular member 77, such as a primary access device used to intubate a narrow constriction such as a bulge orifice. However, what are the structural modifications that allow the wire guide to be temporarily connected to a device that is introduced with or over it? It should be understood that it comprises an embodiment of a connection area 14 intended for remote disconnection. For example, FIG. 6 shows another embodiment of the present invention in which the connection region 14 is not part of the tubular member passage 27 but comprises an external connection element or channel 30. The illustrated external channel 30 has a passage 31 formed therethrough, which can be either integrally formed with the catheter body, or can be glued or otherwise attached to the catheter body. In addition, the outer channel 30 may include any structure that forms a short sheath that surrounds the tubular member 77, a plastic or metal ring, or other passageway 31 that can form a connection region 14 with a wire guide. .

  FIG. 30 illustrates an embodiment of an external channel 30 for a device that does not have an internal passage. The elongate medical device 10 includes a wire-guided wire 111, where the connection region 14 includes an outer sleeve 112 of shrink wrap material adhered to the wire 111 and first and second ends 75, 76 of the connection region 14. An outer channel 30 having an inner sleeve 113 made of a radiopaque material that acts as an indicator 17, 18 and is bonded to the first sleeve 112. A standard wire guide (such as a 0.021 inch METRO ™ wire guide) is fed through the connection area and the two wires are advanced through the tubular member already introduced into the body to the treatment site or the wire The guide wire 111 is extrapolated to the proximal end of a standard wire guide (which may also be connected to a tubular member) placed in the body and sent to advance to the treatment site. The connection is released at the treatment site.

  FIG. 14 shows another embodiment in which the connection region 14 includes a connection ring 63, which in the illustrated embodiment is an illustrative wire collection basket 64 (for capturing gallstones). Attached to the distal tip 74 of a retrieval device 64, such as a modified version of the WEB ™ extraction basket of Wilson-Cook Medical Ink. The illustrated ring 63 is preferably made to be axially rotatable so that it can better accommodate the wire guide 11 that passes through it and engages the first device 10. The coupling ring 63 is not provided to secure the engagement of the internal passage, but in the shaft portion of the elongated medical device 10 (in this particular embodiment, made of coiled wire). This is an option for certain devices that lack proper passages. The ring 63 requires the least amount of relative movement between the devices required to release the connection and is advantageous when the surgical site is short or when other anatomical constraints are encountered.

  FIGS. 31 to 36 show a series of alternative embodiments of the connecting region 14. FIG. 31 shows a tubular member 77 in which the connecting region 14 is provided on another element, which in the illustrated embodiment is a shaft part slidably arranged in the second passage 115. Via a cannula portion 115, which includes an elongated engagement member 89 having 164 and extends from the distal end 12 of the tubular member 77 and includes first and second openings 75, 76 that penetrate the wire guide 11. The wire guide 11 is engaged. By placing the elongated engagement member 89 in the second passage 115, the first passage 27 is ready for injecting material or passing the second wire. The embodiment of FIG. 32 also includes another elongate engagement member 89 in the second passage 115, which further comprises a coupling region 14. In the illustrated embodiment, the elongated engagement member 89 extends from the side access port 15 and includes a distal ring or loop 45 that captures the wire guide and connects the devices together. Optionally, after disconnection, the loop 45 can be folded and pulled through the passage 115.

  FIG. 33 is a tubular member wherein the first end 75 of the connecting region 14 terminates proximal to the distal end 12 of the member and the second end 76 is located near the distal end 13 of the tubular member. A tubular member with an access port 15 is shown. The wire guide 11 is fed into the coupling region 14 so that the distal end 25 of the wire guide 11 is at an angle from the tip 12 when exiting from the most distal side access port (first end 75). . With such a configuration, the doctor rotates the tubular member 77 to move the distal end portion 25 of the wire guide 11 to, for example, a specific branch 48 or 49 of a bifurcated tube or blood vessel. It can be easily turned in the direction of the target. The distal end 12 of the tubular member 77 may be closed or provided with an opening in the vicinity of the tip near the second end of the connecting region, i.e. the first end 75 of the connecting region. Alternatively, the wire guide 11 may be coupled in the same manner as in FIG.

  FIGS. 34 to 35b show an embodiment of the invention in which the wire guide 11 is adapted to be hooked to the connection region 14 in the connected state. In the embodiment of FIG. 34, the wire guide 11 includes a crooked distal portion 116, such as the illustrated “sheep cane”, whose distal end 25 and adjacent distal portion 60 are side portions. Engage in the connecting region 14 of the tubular member 77 in the passage 27 as much as necessary to reliably achieve engagement via the access port 15. It is preferable that the wire guide 11 has a size that allows proper frictional engagement with the passage 27 in the passage 27 and can prevent the wire guide 11 from being carelessly detached. In the related embodiment shown in FIGS. 35 a and 35 b, the distal hook portion 116 of the wire guide 11 is inserted into the distal opening 19 of the tubular member 77 that includes a radiopaque marker band 17 in the vicinity. It is made so that. The illustrated distal hook portion 116 comprises nitinol or other superelastic material that can be heat set to a helical shape 117 and is pre-set once disengaged from the passage 31 in the connection region 14. It wraps around itself back to form a closed shape, creating a closed loop end 118. Since it has such a structure, the hook portion 116 can be kept out of the way when the second device is returned to the wire guide 11 by returning it. Optionally, the tubular member 77 is a longitudinal channel or proximally from the side access port 15 that at least partially contains the connected wire guide 11 while the device is integrated and advanced to the treatment site. An extending recess or a distal opening 19 may be included.

  Another embodiment of a method for connecting the tubular member 77 to the wire guide 11 is shown in FIGS. 36 to 37, wherein the tubular member comprises a pair of coaxial members 100, 119, each member being a connecting region. 14, including slotted openings or channels 120, 121 extending across the entire length (distal end 12 to side access port 15), when aligned with each other, guide wire guide 11 laterally from open passage 31. When it is not aligned, it is closed by one of the inner 119 and outer 100 sheath members. Proximal portions (not shown) of the inner and outer members 100, 119 include proximal markings or structures so that the physician can determine when rotational alignment has occurred to disengage. Is desirable. Instead, the slots 120, 121 extend longitudinally when they overlap each other or are aligned in some other manner, indicating that the alignment has allowed the wire guide and passage 31 to be disconnected. Radiopaque stripes may be included.

  The embodiment of the connection region 14 is shown merely for the purpose of illustrating many options that can be selected by those skilled in the art when the catheter and wire guide are connected together and guided to the working site. The choice is influenced by the nature of the treatment and the equipment used. Other selected embodiments include, but are not limited to, releasable or breakable sutures or wires that extend along or through the catheter to capture the wire, compatible with both devices. And surface structures or elements that can be connected, temporary or peelable binders or adhesives, magnets, or other means for temporarily connecting two medical devices.

  A device made for remote disconnection allows a clinician to align or engage between a given device and a wire guide or guide member to which the device is temporarily connected for a particular procedure. Preferably, it includes an alignment indicator system that allows the current state of the display to be determined. In procedures where the device utilizes fluoroscopic guidance within the surgical site, the strategically placed radiopaque indication provides a convenient means of determining device alignment and confirming that it has been disconnected. In the present invention, the imageable marker need not be of a particular type. For example, ultrasound reflective markers may be used instead of radiopaque bands or other markers. Also, the number and placement of markers is not important. The alignment indicator system of the present invention allows the first elongate device 10 and the wire guide 11 to display an external imaging method, a direct observation method (from the outside) to indicate that the connection between both devices has been released within the treatment site. Predefined or pre-adjusted, which guides the doctor via tactile methods, or by sound or visual alarm sensors (eg, an indicator light placed near the proximal end of the device is activated) Any suitable system including methods or means may be provided.

  4 and 5, the procedure for releasing the connection between the first device 10 and the wire guide 11 in the treatment site is performed near the distal portions 13 and 60 of the first device 10 and the wire guide 11, respectively. The additional placement of one sign system 16 makes it much easier. This marking system is a series of radiation non-transmissions that visually guide the physician or practitioner under a fluoroscope when the first device is coupled with the wire guide and when the wire guide has passed through the coupling region 14. A transparent marker is provided. Because there are relatively few replacement procedures that can be done under direct visual observation, the distal marker 16 is typically a series of external imageable bands, markings or radiopaques such as iridium, platinum, tungsten, gold, barium, tantalum, etc. Other labels with sexual (high density) material are included. The label is usually overlaid, glued, or incorporated at the desired location of the device, which is convenient to align with other radiopaque labels or structures. The illustrated first (or distal) marking system 16 includes a series of radiopaque markings on both the first elongate medical device 10 (tubular member 77) and the wire guide 11, and the distal end of the tubular member. Optional distal imageable marking 17 provided near the distal end 12 (or first end 75 of the connecting region), proximal imaging provided near and distal to the side access port 15 This includes a possible marking 18 and a distal imageable portion 26 or marker provided near the distal end 25 or distal portion 60 of the wire guide 11. The distal marking 17 shown in FIG. 4 includes a radiopaque ink that is sufficiently radiopaque for contrast with the catheter shaft, and in the illustrated embodiment, the catheter shaft is also a substrate polymer. It is rendered radiopaque by adding barium sulphate or other suitable material. Proximal imageable marking 18 comprises a band of iridium or platinum glued or otherwise attached to the catheter surface adjacent to the distal end of the aperture containing the side access port 15. The band is sufficiently radiopaque when attached to the tubular member, and the tubular member may also include a radiopaque material or pigment. In FIG. 5, the distal radiopaque marker 17 of the tubular member 77 comprises a band similar to the band 18 at the proximal end 76 of the connection region (side access port 15). The illustrated distal radiopaque wire guide 26 (FIG. 5) includes a coil spring made of platinum or another radiopaque material such as tungsten or gold. The use of a radiopaque filler or ink can also be considered as a means for making the radiopaque wire guide tip 26. Positioning the radiopaque marker 18 near the second end 76 of the connection region 14 advantageously provides a target point, and the physician passes the radiopaque tip 26 of the wire guide past it. It is possible to know whether the engagement has been released. In the illustrated embodiment, the marker 18 is typically provided proximally and adjacent to the side access port, but can be placed in any suitable location useful for alignment with the wire guide; As shown in FIG. 6, it may be arranged near the port or aligned with the port. Alternatively, the marker 18 is not limited to the area adjacent to the side access port and may comprise a radiopaque stripe or sleeve that extends over the entire length of the connection region. One such embodiment is shown in FIG. 31, where the illustrated metal coupling cannula 114 includes a radiopaque material such as platinum or iridium. In the embodiment of FIGS. 14 and 32, the coupling region 14 includes a coupling ring 63 that allows the physician to engage when the radiopaque distal portion 26 of the wire guide passes through the ring. It would be desirable to have more radiopacity to help determine if the bond has been lifted.

  A second system or type of marker 21 is shown in FIGS. 4 and 8, which is the first device 10 / tubular member that is outside the patient's body when the distal portion 13 of the device is within the treatment site. 77 is provided at the proximal portion 36. In normal operation, the proximal indicator 21 can be viewed directly by the clinician during the procedure as a primary or secondary means of alignment confirmation. In the gallbladder embodiment of FIG. 8, the proximal marker 21 comprises a marker 35 provided around the tubular member 77, preferably in a color or pattern that contrasts with the color or pattern of the tubular member 77. , Including a series of printed bands extending from 160 cm (first or distal end 62) to the 166 cm mark (second or proximal end 61) as measured from the distal tip of the catheter. The first end 62 (160 cm) represents the alignment point with the corresponding proximal alignment mark 37 located on the wire guide and connects as soon as the relative position between the two devices 10, 11 is changed. An alignment point 81 is provided to indicate that is released. When the proximal alignment mark 37 of the wire guide is repositioned towards the second end mark 61, the two devices will reach the detachment point 82 where the disengagement occurs, and the color band will be disengaged when the position is further changed. It plays a role to warn of the impending. In the embodiment of FIG. 4, the proximal marker 21 comprises a continuous band of contrasting color schemes extending from 160 cm to 166 cm. As already mentioned, the position of the proximal marker is not particularly important but is preferably configured to remain visible to the practitioner during normal procedures. The band 35 may include a gradual transition in color (e.g., yellow to orange and red) indicating the relative proximity to the detachment point 82. In the illustrated embodiment, a 166 cm mark at the proximal end of the marker strip 35 is located near the distal end of the optional proximal side access port 20 that provides an entry point to the passage 27 of the second wire guide. However, this technique is described below. When used outside the biliary system, such as in the treatment of blood vessels, lungs, urinary organs, etc., the proximal marker 21 has a different length from the distal tip of the catheter, that is, the distance required to access the treatment site. It is often provided at an appropriate position related to the. Desirably, the length (6 cm) of the first device marker 35 corresponds to the length of the connecting region 14 (shown in FIG. 5).

  As pointed out above, the 160 cm to 166 cm long region in the sign 35 of the proximal sign system 21 is almost always out of the patient and the endoscopic channel so that it can be viewed by the clinician during the procedure. It is conveniently provided at a position on the exiting tubular member 77. In the illustrated embodiment, the second alignment point 37 of the wire guide is such that the distal portion 160 cm of the illustrated wire guide is visually distinguishable from the proximal portion 25 cm so that the METRO® wire guide (Wilson-Cook) A solid portion such as a shrink wrap or coating of a different color and / or pattern that is visually contrasted with the distal portion 60 and the distal portion 60 and / or the intermediate portion 97, including the spiral feature of the medical ink) Indicated by the color change between the proximal portion 59 with a color scheme. Alternatively, a contrasting color or ink or a suitable material may be applied to the outer surface of the wire guide 11 and establish a detachment point 82 resulting from alignment with the point 61 of the first device 10. One band may be affixed at a suitable location near the junction 37 between 60 and the proximal portion 59. When the second alignment point 37 is aligned with the distal end 62 of the proximal marker 21, the wire guide is such that the distal end 25 of the wire guide is aligned with the distal end 12 of the first device 10 / tubular member 77. 11 is provided. Alternatively, the wire guide may include a single narrow marking at the second alignment point 37, eg a plurality corresponding to both the proximal end and the distal ends 61, 62 of the proximal indicator 21. May be included. The wire guide 11 and proximal indicator 21 of the catheter 10 comprise any means suitable for providing a visual indicator, such as shrink wrap, ink, band, surface etching or other treatment.

  A third type 83 of alignment is shown in FIGS. 26a and 26b. In this figure, first and second endoscope alignment indicators 84, 85 are in the middle portions of the first elongate medical device 10 (or second catheter, etc.) and the wire guide 11, respectively, and their distal ends. As the part is advanced within the treatment site 41, the first and second indicators 84, 85 are usually provided within the viewable area 86 between the papilla 40 and the distal end 87 of the accessory channel. It has been. This allows the practitioner to monitor the relative alignment of both in order to determine when disconnection has occurred in the tube 41 (bile duct system). In the illustrated embodiment, the wire guide and each distal end of the first catheter member (not shown) both enter the bile duct 41 across the fater papilla 40. An optional 10 cm marking 29 (shown as a pair of print bands in FIG. 4) may be provided on the first elongate medical device 10 that is visible when the device is introduced into the tube 41. The 10 cm mark 29 can be used as a guide to indicate that the first device 10 has advanced a minimum “safe” or sufficient distance into the tube, as shown in FIGS. 26a and 26b. As shown, when the 10 cm mark 29 disappears from the field of view, the above state is indicated. At this point, the endoscope alignment indicators 84, 85 are typically in the viewable area 86. In FIG. 26 a, the first endoscope alignment indicator 84 of the catheter is proximal to the corresponding second endoscope (wire guide) indicator 85 so that the wire guide 11 is completely on the first device 10. It is shown that they are connected (that is, completely traversing the connecting area). In the illustrated method, the practitioner utilizes the intermediate display system 83 to move the first device 10 to a stationary wire guide 11 (usually to maintain access within the tube, as shown in FIG. 26b). To determine whether the uncoupling of the device 10 has occurred. When the two indicators 84, 85 are aligned, the distal end of the wire guide exits the proximal end of the connection region or side access port and is disconnected or disengaged. Different color schemes such as black on the distal portion 60 (eg, 6 cm distal) of the wire guide 11 as an additional endoscopic indicator to prevent loss of wire guide access from the tube during disconnection May be used for comparison with the intermediate portion 97 (shown in FIG. 7). When the physician sees the black portion of the wire guide appear from the nipple, the wire will be pushed back into the tube to minimize the risk of having to re-intubate. If the connection has not been released yet, but the black portion 60 of the wire guide can be confirmed with an endoscope, the connection with the wire guide 11 can be safely performed without causing the risk of losing access. The tubular members 77 are further advanced together into the tube.

  An example of a non-visual alignment system is shown in FIG. In this figure, when the wire guide 11 passes through the second end 75 of the coupling region 14, for example, the side access port 15, the practitioner feels or perceives contact between the two, and further disengages when the position is changed. As shown, the surface includes a discontinuity 160 in the surface, such as a bead. The illustrated side access port 15 is flexible, including an opening 159 sized to allow the wire guide 11 to pass freely but temporarily create resistance when the beads 160 pass. A skirt portion 158 is provided. In addition, the skirt 158 advantageously functions as a seal that helps prevent bile, blood, and air from leaking into the passageway of the tubular member. Other possible surface discontinuities include wrinkles, ridges, teeth, depressions, or roughened sections that are appropriately configured with the side access port 15 or connecting region 14 and are tactile to the practitioner. Feedback, thereby providing a guide to the state of alignment and engagement between the two devices.

  Endoscopic devices used to perform medical procedures within the bile duct system are commonly referred to as “primary access devices”, including the initial devices used for procedures that are intubated into the odddy sphincter and access the tube. Generally, it is divided into “secondary access devices” that are exchanged with primary access devices to perform one or more procedures within the site. Examples of primary access devices of the present invention include a sphincter resection knife (shown in FIGS. 10 and 11) for resecting the sphincter to enlarge the opening to the tube, and a needle knives used also for sphincter resection (Not shown) and an ERCP catheter (FIGS. 4 and 5) adapted to inject contrast media into the tube for radiographic imaging. The sphincter blade and the needle knives may be made to perform two or many functions or operations, such as injection of contrast agents and other agents. Some sphincters include a balloon that is used to sweep the tube to remove clogged stones or stones. There are also devices such as extraction balloons that are used as both primary and secondary access devices. In a pancreatic gallbladder procedure, the primary access device is replaced with a secondary access device, which typically includes removal or crushing of stones, tissue sampling, delivery of therapeutic radiation or light, stenosis. It is designed to perform a therapeutic function, such as expanding or stenting a part (such as a tumor) or placing a stent for drainage. If the secondary access device is the last device to be used in a particular procedure, it does not need to be adapted for remote disconnection, but has at least one distal connection region without the need to add an extender It is desirable to allow the device to be advanced over a short wire. Generally speaking, any secondary access device (extraction, dilation, photographic balloon, dilator, forceps, brush, stent delivery catheter, brachytherapy, etc. that is normally introduced into the bile duct system by extrapolating to the wire Therapy catheters, lithotriptors, baskets, snares, etc.) also allow for positive confirmation of the appropriate connection area within the distal portion of the device and, but not necessarily, the disconnection and relative alignment of the device. By adding at least one of the above three types of marking systems, it can be substantially adapted for remote disconnection.

  In order to access the treatment site 41 and perform a medical procedure, the primary access device (first elongate medical device 10), the wire guide 11 and the secondary access device (third elongate medical device 44) of the present invention are used. A typical method used is shown in FIGS. 9a to 9f. The first stage of the illustrated method includes standard endoscopic techniques for accessing the bile duct 41 for performing diagnostic and therapeutic procedures. FIG. 9a shows a duodenoscope 38 inserted into the duodenum 39 through the oral cavity to view the papilla 40 and the oddy sphincter, which is placed at the opening of the common bile duct 41 and pancreatic duct. Yes. In this exemplary method, the dilator catheter 88 and the wire guide 11 are advanced from the attached channel 38 of the endoscope and intubated into the stenosis within the treatment site 41 (tube). Typically, doctors have indicated that during this procedure, the wire guide 11 has been advanced past the tip of the primary access device 10 to assist intubation or the distal end 25 of the wire guide is in the passage 27. Or prefer to judge. As shown in FIG. 9b, the dilator catheter 10 (or other secondary access device) is advanced over the wire guide 11 and the proximal portion of the wire guide exits the side access port 15 into the catheter. As they extend through the channel along, they both exit the accessory channel of the endoscope separately, as shown in FIG. In applications where the size of the endoscope channel is limited, or in other applications where there is limited room to accommodate both devices side by side, the catheter can be placed side by side without increasing the overall diameter. Changes may be made to. This can be accomplished by forming an open channel (preferably one that cannot capture the wire) or by creating a flat longitudinal section along the length of the catheter (not shown). it can.

  As also shown in FIG. 12, the proximal portion 59 of the wire guide 11 is not necessarily fixed, but is usually fixed in place when the distal end 25 is advanced to a desired position in the treatment site 41. The The illustrated wire guide holder 50 is not fixed at some other position on the endoscope, but is partially inserted or covered over the opening 52 of the access port 51 to the attached channel to provide a seal. This is an improvement over the prior art devices. The holder 50 can be a ring, a membrane with slits (eg, polystyrene, silicone, or another elastic polymer material), a foam seal with a small central lumen (eg, silicone, polyurethane, etc.), or around the catheter and wire guide And further including an optional integrally formed sealing element having one or more types of seals, including other designs that have the ability to seal and prevent proximally moving fluid from exiting the channel. It is out. The wire guide 11 is a spaced element along one side of the locking portion 66 of the device, such as the bent “spine” shown, using a method of alternating up and down as shown. The wire guide is entangled through a first series of spaces 53 (or channels, grooves, slots, etc.) between and fixed in place. The illustrated holder includes three slots 53 or spaces on the first side of the locking portion 66 so that a second series of three slots 54 or spaces require a second wire for treatment. In order to cope with this situation, it is included on the opposite side of the locking portion 66.

  Unlike other wire guide replacement techniques where the proximal portion of the wire guide is remote from the physician, the short wire normally used in the illustrated remote disconnect or ultrashort wire technique typically results in a wire guide. Because the proximal end of the device is within the physician's work area, the proximal end can be easily accessed when the secondary device is introduced to the treatment site. The holder shown is made so that the proximal end of the wire guide faces down and out of the way of the physician, but when the extra device is sent over the wire, the proximal end is unfastened. When it is, it may return to its original shape and enter the work area around the endoscope access port, which may interfere with the treating physician. To alleviate this problem, FIG. 7 shows that the proximal end 59 of the wire guide 11 is oriented at an angle 79 relative to the distal and intermediate portions of the wire so that the proximal end 58 / proximal end portion 59 is , Usually facing down and away from the practitioner (if so rotated), and therefore placed away from the work area around the endoscope access port, A wire guide 11 is shown that also allows the physician access to the proximal end to advance the next device. The illustrated embodiment includes a 185 cm nitinol core wire guide 11, about 40 cm to 45 cm out of the endoscope and proximally so that the third elongate medical device can be advanced over it. In this wire guide, it is desirable that the bend 80, or flexure position, be provided approximately 20 cm to 30 cm from the proximal end, but the useful range is from 0 cm. It may be anywhere as long as it is between 50 cm. The useful angle 79 of deflection will vary depending on the physician's preference, the configuration of the endoscope and wire guide holder, and other factors, but is typically about 30 degrees to about 120 degrees for endoscopic procedures, as shown in the illustrated embodiment. Then, the range of 45 degrees to 90 degrees is more preferable. To create the bend 80 in the Nitinol wire guide 11, the material can be thermoset or mechanically overstressed (cold working) to provide the desired bend angle 79 and the desired bend 80 radius (eg, Small, relatively sharp bends, or larger, more gradual or round bends).

  Next, as shown in FIG. 9c, once the wire guide has been advanced to the desired position within the surgical site, the catheter is advanced or retracted over the wire guide to a position for performing the intended operation. . In the illustrated method, this operation includes injecting a contrast medium 43 into the tube 41 so that an obstacle, in this specific example, a stenosis is visible. Another commonly used method for diagnosing possible obstructions in the tube is to first introduce the sphincterectomy 32 (FIG. 10) and inject the contrast medium 43. If an obstruction such as a calculus is found, the sphincter is resected and a second device, such as a basket or balloon, is extrapolated and introduced into the original wire guide to extract the calculus from the tube. It should be understood that the nature and order of the devices used is not critical to the present invention, as there are various other procedures that can be used.

  When the first operation is completed, the first elongate device 10 is removed from the tube 41. As shown in FIG. 9d, the practitioner may perform device IDE by repositioning the ERCP catheter and the distal ends of the wire guides 12, 25 face-to-face by advancing the catheter (shown). Alternatively, wire guide IDE can be performed by unlocking wire guide 11 from the wire guide holder and pulling back until distal end 25 is disengaged from the catheter. Alternatively, the clinician can disengage or disengage the device and the wire guides 10, 11 by moving both devices simultaneously until the wire guide 11 exits the coupling region, The connection is released while keeping them in the treatment site 41. As discussed above, the imageable indications 18, 26 on the distal portion 13 of the catheter 10 and the distal end 25 of the wire guide 11 are respectively disengaged or disengaged as shown in FIG. 9e. This is used to confirm this under fluoroscopy. The proximal indicator 21 and / or intermediate display 83 (FIGS. 26a and 26b) shown in FIGS. 4 and 8 are also utilized to confirm that the disconnection has occurred within the treatment site. This optional step is illustrated in FIG. 12, where the wire guide 11 is inserted around (and / or into) the opening 52 of the biopsy port of the endoscope. ) In the locked position 161 in the attached exemplary wire guide holder 50 and then disengaged, the engagement adjacent the primary access device 10 so that the proximal markers 21 of the two devices 10, 11 can be aligned. It is arranged at the stop release position 162. As long as the proximal mark 37 of the wire guide 11 remains distal to the alignment mark 81 of the primary access device 10, the practitioner will have the distal tip of the wire guide catheter in the tube (not shown). It can be seen that it still protrudes from the distal end. When the wire guide 11 is pulled (or the primary device 10 is advanced) so that the two marks 37, 81 are in alignment, the practitioner has the distal ends 12, 25 of the two devices 10, 11 in the tube. Know that they are almost aligned. As the practitioner continues to pull the wire guide 11 or advance the catheter 10, the alignment mark 37 aligns with the disengagement mark 82, which in the illustrated embodiment is that the distal end of the wire guide is channeled or connected. Fully pulled out of the area, indicating that the two devices have been disconnected in the tube.

  Once disconnected, either of the devices 10, 11 can be used as a conduit for introducing the third elongate medical device into the treatment site. In the exemplary method shown, the third elongate device 44 feeds the rear end 58 (not shown) of the wire guide 11 into the distal opening 19 of the dilator catheter 88 and out of the side access port 15, A dilator catheter 88 (FIG. 9f) is provided that is introduced over the wire guide 11 by advancing the dilator catheter 88 over the wire and advanced into the accessory channel of the endoscope and then into the tube 41. ing. Typically, the practitioner chooses to remove the first device 10 before introducing the third device 44 if it is no longer needed. This allows the practitioner to move the catheter out of the tube and endoscope channel in one continuous motion while keeping the wire guide in place (eg, locked into the wire guide holder 50 of FIG. 12). It is easily done by pulling out. When the first device 10 is removed and the third device 44 is advanced to the treatment site, a second medical operation (for example, expansion of the stenosis) is performed. If another operation is required, the third catheter-type device (fourth elongate medical device) is advanced over the original wire guide 11 and so on.

  As previously mentioned, the present system for extrapolating and replacing a device with a wire guide is introduced using an ultra-short wire method and adapted to allow a long wire guide to be introduced through a properly configured medical device. be able to. In other examples, it is desirable to convert an ultra short wire introduced into the body to a long wire when used with an incompatible device. FIG. 13 uses either a conventional medical device without a side access port for intravascular replacement (“long wire”) or a conventional quick changer that requires a somewhat longer external exchange (eg, 30 cm). A wire guide extender 56 for use with the present system is shown to accommodate external exchange. In the illustrated system, the wire guide 11 includes a coupling mechanism 55 at the proximal end 58, such as a thread or loop of wire, which is shown at the distal end of the wire guide extender 56. It is configured to engage with a second coupler 57 such as a hook. This effectively extends the length of the wire guide so that it can be exchanged over a conventional wire when a specific device not designed for ultrashort wire replacement is used with the system. . As will be readily appreciated by those skilled in the art, there are a variety of coupling mechanisms that are suitable for extending the wire guide for replacement purposes. They include locking or screw mechanisms, sheaths, bands, etc. that allow the two parts 11, 56 to be joined temporarily or permanently. Another option could be to use an adhesive strip or similar device to attach the wire guide 11 and the extender 56 to each other.

  The illustrated system of the device, which allows for disconnection within the surgical site and eliminates the need for external exchange on the wire, provides a second wire guide to the surgical site via a catheter that has been introduced into the body and not disconnected. And can be adapted to be introduced after installation of the first wire guide. FIG. 10 shows a proximal access port 20 (third opening) located within the proximal portion of the catheter, typically at a location outside the patient body during the procedure (approximately 166 cm in the illustrated gallbladder device example). ) Is shown. Proximal side access port 20 may include an optional sleeve cover that slides over and closes the access port when the access port is not in use.

  When the second wire 46 is introduced, in the method shown in FIGS. 9 a to 9 f, the illustrated sphincter resection knife 32 once disconnected from the first wire guide 11 is not removed from the patient body. Instead, the tip of the second wire guide 46 (third elongate medical device 44) is fed into the wire guide passage 27 through the proximal opening 20 and passes through the endoscope into the tube 41. It is advanced to. In the example of FIG. 11, the first wire guide 11 is placed on a first branch 48 having a bifurcated branch, such as a portion where the common bile duct 41 branches into two liver lobes. The sphincter cleaver 32 carrying the second wire guide is rotated and deflected by the physician pulling the cutting wire back using the handle, and the advancing second wire guide on the opposite branch 49. The branches can be intubated with wire guides 46. A sphincter resection tool 32 having a handle that allows the catheter body to rotate axially is suitable for positioning the distal cut 33 in or against the opposite tube for wire delivery. Once the second wire 46 is in the desired position, it can be locked in place (eg, utilizing the second series of slots 54 of the wire holder 50 shown in FIG. 12). After the sphincter blade or other primary access device 10 has been removed from the second wire 46, the wires 11, 46 are then placed, followed by additional devices such as stents to restore or improve the patency of the tube. Or it can be used to introduce.

  To remove the original catheter device 10 from the short second wire 46, an exchange may be performed, such as by adding a wire guide extender 56 of FIG. If the portion between the proximal (side) and proximal access ports 15, 20 is configured to allow the wire to exit laterally from the passage, the catheter may be peeled away from the wire 46, or Either of these is required. The latter can be achieved by forming a weak portion in the wall, for example by creating a score line, slit 67, or other pre-weakened area, as shown in FIG. This can be accomplished in a number of well-known ways, including forming intermittent rows of perforations through parts or all of which are weakened longitudinally. Alternatively, the tubular member may comprise an intact catheter that is made to break upon application of sufficient lateral pressure by a wire guide present in the passage. One way to do this is to make the wall 68 adjacent the wire guide lumen 27 sufficiently thin (FIG. 16) and / or made of a suitable polymer so that the catheter can be removed from the patient as it is withdrawn from the patient. When a lateral force is applied, the wire guide 46 is easily broken or torn through the thin wall 68. Materials with a molecular structure suitable for easy cracking, such as isotropically oriented polymers, may be used, or the polymer may be treated in some way to facilitate cracking. The entire wall of the catheter may be easily broken, or a second low hardness portion that extends to the outside of the wire guide lumen may be provided by coextrusion in the longitudinal direction, etc. It may be limited to a specific position in the circumferential direction. Instead of (or in addition to) making the wall easy to break, a tab or other element may be attached to or integrally formed with the catheter to make it easy to break and manually remove the wire guide Good. Another way to access the guidewire lumen to separate the catheter from the wire is to consider a sharp tool or similar device. Another option is to penetrate the groove through the wall to form a narrow open channel, or a sealable or locked closure, so that the two edges are pressed together or interlocked by their complementary structure Is to be done. The closure is designed to crack open or unlock when the lateral force applied by pushing and pulling the wire guide is sufficient to open the closure.

  Returning to the IDE method shown in FIGS. 9a to 9f, as mentioned above, the friction encountered when introducing the primary access device and the mating wire guide through the attached channel of the endoscope may be Can cause premature disconnection before the two devices reach the treatment site. FIGS. 23-25 show that the wire guide 11 can be released to the tubular member 77 so that undesirable disengagement or relative movement does not occur when both devices are introduced or manipulated within the patient. FIG. 6 shows different embodiments of an elongated engagement member 89 that is adapted to be secured to the body. In FIG. 23, the elongated engagement member is preferably made of a flexible polymeric material with suitable longitudinal strength, such as nylon, which is similar in construction to a standard pusher member. A stop member 90 is provided. Other suitable materials include PEEK, PTFE, stainless steel, nitinol, polyethylene, or polypropylene materials of various densities. The wire stop member 90 has a diameter (eg, 0.35 inches) that substantially fills the inner diameter of the passage 27 of the tubular member 77 and the side access port where the wire guide 11 enters the coupling region 14 (passage 31). When fully advanced to a point distal to 15, the wire stop member 90 contacts the wire guide 11 and wedges the wire guide 11 to the inner wall of the passage, whereby the longitudinal direction of the wire guide 11 relative to the tubular member 77. It is desirable that the movement of the lens is substantially prevented. Although FIG. 23 shows a wire stop member 90 disposed within a multi-lumen tubular member 77, it can also be used with a multi-lumen device (eg, sphincterectomy). FIG. 24 shows the proximal hub 92 (male luer fitting) of the wire stop member 90 in the retracted position 94, in which the wire stop member 90 engages the wire guide 11 and engages it. Is not advanced to a region or point 91 immediately distal to the side access port 15 in the passageway to the extent that it is locked or wedged. This is because the proximal hub 92 is advanced to the forward position 95 and the hub 92 engages a proximal (female) fitting 93 provided in the proximal access port 23 of the primary access device 10. Is the time. If the practitioner wishes to reposition the two devices 10, 11 relative to each other, the proximal (male) hub 92 is removed from the female proximal hub 93 and rearward until the wire guide 11 is released. Pull on. Although not necessarily, it is desirable that the wire stop member 90 be removable from the passage 27 so that medication, additional wire guides, etc. can be introduced through the passage 27. The elongated engagement member 89 is typically not used with a secondary access device unless a wire has already been introduced into the treatment site and the wire guide need to be secured to the device.

  A second embodiment of the elongate engagement member 89 is shown in FIG. 25, but this embodiment creates a loop around the wire guide within the suture, wire, cable, or passage 27, and the snare Or other threaded material 96 that is releasably engaged in other manners. The wire guide 11 is provided with a groove or a recess (not shown) in which the snare member 96 is placed so that the wire guide 11 does not slide along the snare member 96. A snare member 96 can be attached to the working portion of the handle to allow the practitioner to fully control the operation. When the practitioner wants to disengage the wire guide 11 from the tubular member 77, the tension on the snare member 96 may be released, or one end may be released so that the wire guide 11 can be pulled out from the passage 27. Alternatively, the snare member 96 may be provided outside the tubular member 77 to releasably engage and secure the wire guide 11.

  Another embodiment of the elongated engagement member 89 is shown in FIGS. In FIG. 58, the elongated engagement member 89 comprises a wire stop member 190 having a softly made distal tip. This soft tip portion deforms (crushes) the end portion of the wire stop member 190 to reduce the area of surface contact between both the inner wall (of the passage 27) of the tubular member 77 and the outer peripheral surface of the wire guide 11. Make it expandable. As the surface area increases, the frictional force increases, resulting in an increased stop or “braking” force between the two components. In addition, the soft tip also reduces the possibility of damaging the tubular member 77 or the tubular member when the stop member 190 is caught on or pinched between the wire guide 11 or the tubular member 77. The wire stop member 190 further comprises one or more radiopaque markers 196 disposed near its distal tip. These radiopaque markers 191 assist the user in determining whether the wire stop member 190 is engaged with the wire guide 11 using fluoroscopy. FIG. 58 shows a wire stop member 190 disposed within a multi-lumen tubular member 77 of the type used in a multi-lumen device such as a sphincterotome.

  59a is a cross-sectional view of the elongated member 89 of FIG. 58 taken along line 59-59. As shown, the wire stop member 190 is substantially circular in cross section and is made somewhat smaller in diameter than the inner diameter of the passage 27 of the tubular member 77. Although wire stop member 190 is shown as having a solid cross-section, it should be understood that alternative embodiments employ non-solid cross-sections. For example, the wire stop member 190 may include a lumen that extends through part or all of its length. With the lumen, the wire stop member 190 can be crushed and the frictional contact between both the inner wall (of the passage 27) of the tubular member 77 and the outer peripheral surface of the wire guide 11 can be increased. The lumen can also be utilized when delivering contrast or other agents through the wire stop member 190. In connection with the latter, the wire stop member 190 may comprise an injectable stylet.

  59b is an alternate cross-sectional view of the elongated member 89 of FIG. 58 along line 59-59. As shown, the wire stop member 290 is not circular in cross section. Specifically, the wire stop member 290 engages and deforms around the wire guide 11, and the engagement between the wire guide 11 and the inner wall (of the passage 27) of the tubular member 77 in the engagement region 191 (see FIG. 58). A plurality of outwardly projecting ribs 291 are provided so that the gaps between them can be filled more easily. The ribs 291 help maintain the wire stop member 290 in the center within the passage 27 of the tubular member 77 and allow the wire stop device 290 to inadvertently pass through the side access port 15 (see FIG. 58). It helps to reduce the possibility of getting lost. Grooves 292 formed between each adjacent pair of ribs 291 provide a passage for contrast agent or other agent flowing through passage 27.

  FIG. 59c shows yet another cross-sectional view of the elongated member 89 of FIG. 58 taken along line 59-59. As shown, the wire stop member 390 is not circular in cross section. Specifically, the wire stop member 390 is slidably engaged with a recess having a similar shape provided on the inner wall (of the passage 27) of the tubular member 77 over a certain length. A pair of outwardly projecting flanges or wings 391. In other words, the wire stop member 390 has a non-circular cross-sectional shape that matches the non-circular cross-sectional shape of the passage 27 of the tubular member 77. Of course, it should be understood that the cross-sectional area of the wire stop member 390 is made somewhat smaller than the cross-sectional area of the passage 27 so that the wire stop member 390 can slide freely relative to the passage 27. It should be understood that the cross-sectional shape of the passage 27 is still a shape that can accommodate an elongated member having a circular cross-sectional shape such as the wire guide 11.

  The cross-sectional shape, more precisely, the wing 391 prevents the wire stop member 390 from twisting in the passage 27. More importantly, the wing 391 prevents the wire stop member 390 from inadvertently passing through the side access port 15 (see FIG. 58) of the tubular member 77 and exiting. As shown, the wings 391 are disposed along opposite sides of the passage 27 substantially opposite the side access port 15 so as not to interfere with the movement of the wire guide 11 passing through the side access port. Is desirable. Other non-circular cross-sectional shapes can be employed to achieve the above functions and benefits. For example, the wire stop member 390 and the passage 27 may have a square or triangular cross section. The cross section of the passage is not necessarily, but it is desirable that the cross section can accommodate the wire guide 11 therein.

  In FIGS. 61 a-61 b, the elongated engagement member 89 comprises a wire stop member 490 that extends through the second passage 427 of the tubular member 77. The cross-sectional area or diameter of the second passage 427 is smaller or narrower in the region 429 just distal from the side access port 15 of the tubular member 77 and smaller than the cross-sectional area or diameter of the wire stop member 490. Also, the portion in this region 429 of the wall 428 that separates the second passage 427 from the first passage 27 is made relatively flexible and / or thin.

  FIG. 61a shows the distal end of wire stop member 490 in the disengaged state. In this state, the distal end of wire stop member 490 is proximal to region 429. The cross-sectional area or diameter of the portion of the second passage 427 occupied by the distal end of the wire stop member 490 is greater than the cross-sectional area or diameter of the wire stop member 490. FIG. 61b shows the distal end of the wire stop member 490 in the engaged state. In this state, the distal end of wire stop member 490 is in region 429. The cross-sectional area or diameter of the portion of the second passage 427 occupied by the distal end of the wire stop member 490 is less than the cross-sectional area or diameter of the wire stop member 490. As a result, the distal end of the wire stop member 490 pushes that portion of the wall 428 (which separates the second passage 427 from the first passage 27) and moves it to the inside of the first passage 27, and within the first passage 27 The wire guide 11 is engaged and sandwiched.

  In FIG. 62, the elongated engagement member 89 includes a wire stop member 590 that similarly extends through the second passage 527 of the tubular member 77. The wire stop member 590 includes an inflatable member 591 that is in fluid communication with an inflation device such as a shrimp (not shown) connected to its proximal end. When the inflatable member 591 is inflated, the corresponding portion 528 of the wall separating the second passage 427 from the first passage 27 is pressed. When the wall portion 528 is pushed out toward the first passage 27 as in the embodiment shown in FIG. 61 b, the wall 528 engages with the wire guide 11 and sandwiches it in the first passage 27. It should be understood that other types of expandable devices may be employed in place of the inflatable member 591. For example, an expandable wire basket may be attached to the distal end of wire stop member 590. A separate control wire or mechanical linkage may be employed to press the passage 27 near the wire guide 11 to prevent the wire guide 11 from moving longitudinally relative to the primary elongate medical device 10. .

  FIG. 60 shows the proximal hub 192 (male luer fitting) of the wire stop device 190 in the retracted state 194, where the wire stop member 190 engages the wire guide 11 and engages it. As far as locking or wedged, it has not advanced to a region or point 191 immediately distal to the side access port 15 in the passage 27. This occurs when the proximal hub 192 is advanced to the forward position 195, where the hub 192 is secured to the access port 23 of the primary access device 10 or in the vicinity of the extension tube 198 attached in some way. This is when it comes into contact with and engages with the proximal (female) metal fitting 193 provided on the distal side. If the practitioner wishes to reposition the two devices 10, 11 with respect to each other, he removes the proximal (male) hub 192 from the female proximal hub 193 and back until the wire guide 11 is released. Pull on. Although not necessarily, it is desirable that the wire stop member 190 be removable from the passage 27 so that medication, additional wire guides, etc. can be introduced through the passage 27. Nonetheless, as noted above, the wire stop member 190 may have a non-circular cross-section (see, for example, FIG. 59b), a lumen therethrough, or a contrast agent through the passage 27 with the wire stop member 190 in place. Alternatively, other structures that can deliver other drugs may be provided.

  The wire stop member 190 further includes a proximal shaft portion 197 with increased rigidity, which is formed to prevent twisting or excessive bending when the wire stop member 190 is pushed into engagement with the wire guide 11. Yes. Proximal shaft portion 197 is disposed outside lumen 201 (of elongate primary device 10) and is therefore not supported until wire stop member 190 is fully inserted into passage 27 of primary elongate device 10. Because it is in a state, it is easy to twist or bend excessively. In the particular embodiment illustrated, the rigid proximal shaft portion 197 comprises a PEEK material having a diameter or cross section that is greater than the diameter or cross section of the more distal shaft portion 200 of the wire stop member 191. Alternatively, the high-rigidity proximal shaft portion 197 includes a cover tube disposed so as to cover the shaft of the wire stop member 190. To accommodate the large diameter or cross section of the rigid proximal shaft portion 197, the extension tube 198 includes a lumen 199 having an enlarged inner diameter or cross section that is larger than the diameter or cross section of the lumen 201 of the passage 27. In other words, the extension tube 198 is made to accommodate the increased diameter or cross section of the high stiffness proximal shaft portion 197. Alternatively, the high-rigidity proximal shaft portion 197 may be formed of a relatively rigid material such as a metal wire so that the proximal shaft portion 197 has the same diameter or cross section as the distal shaft portion 200. You may be able to do it. In this alternative construction, the proximal shaft portion 197 can be fed into the lumen 201 of the passage 27, thus eliminating the need for the extension tube 198. It should be understood that the extension tube 198 can be made to be attached to various catheter devices 10 having various proximal access port 23 configurations. In other words, the extension tube 198 can be made attachable to existing catheter devices 10, including those manufactured by other components, and these existing catheter devices 10 can be used with the wire stop member 190. Can be modified as follows.

  The distal shaft portion 200 of the wire stop member 190 may be uniform or non-uniform in physical properties in the length direction. In the embodiments discussed above, the distal shaft portion 200 is made of a single material and has a constant diameter or cross-section so that the distal shaft portion 200 has uniform rigidity or flexibility. ing. Or you may manufacture the distal shaft part 200 so that a physical characteristic may differ in each part. For example, the distal shaft portion 200 may be tapered or stepped (ie, reduced in diameter or cross-section) toward the distal end to increase flexibility for certain medical procedures. You may make it convenient. Similarly, increasing the stiffness of the distal shaft portion 200 toward the proximal end can increase the stiffness of the primary elongate device 10 using the wire stop member 190. Distal shaft portion 200 may use different materials for different portions or sections of the shaft, or may use materials modified in some way to have different properties. When different materials are used, they may be used in combination with the dimensional change of the distal shaft portion 200, or may be used separately from the dimensional change. A surface coating, such as a hydrophilic coating, may be applied to the distal shaft portion 200 or a portion thereof to reduce the frictional resistance when moving the wire stop member 190 through the passage 27 of the primary elongate device 10.

  The embodiment of the elongated engagement member 89 of FIGS. 31 and 32 also includes the connection region 14 of the device 10 configured to be partially retracted into the secondary passage 115. This action creates a frictional engagement with the wire guide, and the elongated engagement member 89 also functions as a stop device to prevent the wire guide 11 from sliding freely within the coupling region 14.

  It should be noted that the embodiment of the elongated engagement member 89, and more specifically the wire stop members 90, 96, 190, 290, 390, provides an intermediate side access port that communicates the wire guide 11 with the internal passage 27. It should be understood that it can be utilized to stay on any type of elongated medical device 10 having 15. In other words, the elongated engagement member 89 can be used with quick exchange, short wire, ultra short wire, and replaceable devices. Furthermore, the illustrated embodiment is available with a device that allows both elements to be fastened so that the first elongate medical device 10 and the wire guide 11 can be introduced together through the channel without disengagement. It represents just a few examples of the types.

  In the present invention and method, when the primary access device is used in the treatment site, the secondary access device is introduced by being extrapolated to a guide device (wire guide) that is disconnected from the primary device in the treatment site. Using the device in a procedure. In the bile duct system, there are many devices that can be introduced to perform various medical procedures, and some examples among them are shown in FIGS. 9F, 14, 17, and 19 to 22, FIG. 27, 28, 39, and 41 to 44, 51, and 53. The illustrated device does not represent all secondary access devices suitable for use in the bile duct system, nor does it limit its use to secondary devices used following the primary device. . The illustrated device is a general type of medical device used for endoscopic procedures in the bile duct system, as well as non-bile duct systems or non-endoscopic procedures performed elsewhere in the body. Some are shown.

  FIG. 17 illustrates a system for delivering a gallbladder or pancreatic drainage stent 69 attached to a delivery catheter 110 (elongated medical device 10) of the present invention. The illustrated COTTON-LEUNG® biliary stent (Wilson-Cook Medical Ink) is attached to the OASIS® one-action stent delivery system (Wilson-Cook Medical Ink) modified for IDE The delivery system extends through the inner lumen 72 of a slidingly mounted stent 69 (when used with pusher member 101 (FIGS. 29a-c)). It should be understood that the illustrated stent delivery catheter 110 is capable of receiving different types of tubular drainage stents in addition to the illustrated types. The connecting portion 14 of the delivery catheter 110 includes a passage 27 between the distal opening 19 and the side access port 15 located 1.5 cm to 2.0 cm from the distal tip. A proximal marking 18 such as the illustrated iridium band is provided about 1 cm just distal to the access port 15. The wire guide 11 advantageously provides a means for exiting the side access port 15 at a point distal to the distal end 71 of the stent 69 and withdrawing the stent 69 with the delivery catheter 110. Greatly supports the ability to reposition the stent within the tube. When the catheter 10 and wire guide 11 are withdrawn together with respect to the stent (which is held securely by the pusher member), the distal edge 71 of the stent 69 slidably disposed about the catheter becomes the delivery catheter. It stops at the triangular wedge point 70 formed by the junction with the wire coming out of it. Thus, because the stent 69 is pulled back with the delivery catheter, the clinician can withdraw the stent partially from the tube so that the proximal anchor flap 73 can extend outside the tube if necessary. A simple and reliable means for providing this will be provided. When placed in the desired position, the wire guide 11 and delivery catheter 110 are disconnected and the latter is withdrawn from the open lumen 72 of the stent 69. In a delivery system in which the wire guide 11 extends through the open lumen 72 of the stent 69, the clinician can retract the delivery catheter 110 without any additional mechanism for releasably connecting the stent to the delivery catheter. The stent cannot be pulled back with the catheter. It should be noted that this method can be readily adapted for other stent designs, particularly for other non-expandable tubular stents and stents having pusher members.

  The exemplary stent delivery system of FIG. 17 differs from the prior art biliary stent delivery system as long as the wire guide 11 and device 10 are remotely disconnected in the tube, as shown in the method of FIGS. 29a-e. It is particularly suitable for deploying a large number of stents, which eliminates the need to reintubate the teat each time a stent is deployed. As shown in FIG. 29 a, the inner delivery member 110 connected to the wire guide 11 exits the endoscope 38 and is advanced through the enormous portion of the orifice 40 into the tube 41. The wire guide 11 does not extend through the stent 69 and the lumen of the pusher member (not shown). As shown in FIG. 29b, the pusher member 101 pushes the stent on the inner member 110 until the distal end 71 of the stent reaches the junction 70 formed at the position where the wire guide 11 exits the side access port. (Alternatively, pusher member 101 may contact the stent to further advance the stent over inner member 110 while pulling back inner member 110 and stent 69). As described above, the joint 70 is in contact with the distal end 71 of the stent, and if the stent has gone too far into the tube for ideal deployment, the stent 69 may be pulled back. Or it can be used to rearrange. As shown in FIG. 29c, when the stent is in the correct position for deployment, the inner member 110 is advanced further into the tube 41 so that there is sufficient room to release the connection. The wire guide 11 is unlocked from the wire guide holder 50 (see FIG. 12) and pulled back until it exits the side access port as shown in FIG. 29d. The inner member 110 is then withdrawn with the pusher member 101 through the stent 69 and removed from the endoscope channel. The wire guide 11 is then advanced again into the tube to serve as a conduit for the next stent delivery system, as shown in FIG. 29e, and the second stent 109 is also in the manner shown in FIGS. Can be deployed with the first stent. Subsequent deployment of additional stents can be done using the same technique as for the original wire guide.

  Other stent or prosthesis delivery systems made for use with the present invention are shown in FIGS. 22, 27 and 39. FIG. 22 shows a delivery system 99 for a self-expanding prosthesis 98, including a Wilson-Cook ZILVER ™ biliary self-expanding stent, or Nitinols, stainless steel, or other Self-expanding stents; ie, self-expanding stents such as prosthetic valves (eg, veins, hearts, lungs, etc.) prostheses, vascular occluders, filters, embolic protection devices, shunts, stent grafts, and the like. The illustrated device comprises an inner member (elongated medical device 10) on which the prosthesis 98 is mounted and an outer member 100 or sheath that restrains the self-expanding prosthesis 98 until deployment. The side access port 15 is located about 3 cm from the distal tip 12 of the inner member 10 and the connection region 14 is completely distal to the prosthesis 98.

  An alternative system for deploying a self-expanding prosthesis is shown in FIG. 39, which allows the inner and outer members 10, 100 to undergo relative repositioning during deployment. It typically includes a series of corresponding slots (withdrawing the sheath 100 while keeping the inner member 10 of the delivery system in place). This allows the coupling region 14 to extend through the prosthesis 98, the wire guide 11 exits the side access port 15 proximal to the prosthesis 98, and the wire guide is positioned inside the prosthesis 98. Can be deployed as is, resulting in a reduced chance of losing access to the surgical site. This is because there are many problems with re-intubation through the deployed stent, and it can cause complications such as movement of the deployed stent, hooking on the stent, and peeling of platelets. It is particularly useful when deploying stents, other prosthetic devices, and other auxiliary devices such as dilatation balloons within the blood vessel. For placement of prosthetic veins and other types of prosthetic valves, re-intubate into leaflets or valve structures to deploy additional valves or introduce seated balloons to press valve support frame against vessel wall to fully inflate It is particularly useful to maintain wire guide access through the valve, especially when it has been demonstrated that it can prove to be difficult and damage the delicate leaflet structure and compromise valve function. .

  FIG. 27 shows an endoscopic bile duct stent 69 and a pusher device 101 (typically 5.0 to 7.0 FR) made for ultra-short wires and quick replacement. This is mainly different from the embodiment of FIG. 17 in that the inner member is missing. Both the stent 69 and the pusher member 101 (elongated medical device 10 in this particular embodiment) are introduced through the outer introducer member 100 and the distal of the pusher device 101 that includes the coupling region 14 near the distal portion 13. The distal end 12 pushes the stent forward and deploys within the tube. A side access port 15 is provided about 6 cm from the distal end 12 of the pusher member 101 (elongated medical device 10) such that a wire guide traverses the passage of the stent 69.

  41 and 42 show another embodiment in which the stent 69 comprises a porcine tail drainage stent 126, such as the illustrated nasal gallbladder drainage stent, which is shown in FIG. Thus, when it is extrapolated to the wire guide 11 for introduction into the bile duct, it is configured to have a straight shape 129, but the deployed shape 128 (FIG. 41) includes a bent anchor portion 127. Although not necessarily, the drainage hole 130 provided along the distal portion of the stent 126 is sized so that the wire guide 11 cannot be easily pulled out (for example, 0.025). Inch), the side access port 15 is preferably sized (e.g., 0.035 inches or more) to allow the wire guide to easily exit. In the illustrated nasal gallbladder embodiment, five drain holes are distributed about 6 mm apart along side access port 15 and distal portion 13 distal to marker band 18. In this particular embodiment, the side access port 15 is also provided with a series of optional drain holes 130 proximally. The interval between drain holes varies depending on the diameter of the winding, but is generally in the range of 5 mm to 1 cm or more. When the wire guide 11 is repositioned relative to the stent 126 to perform an endovascular exchange, the anchor portion 127 becomes coiled in the intended shape when the wire guide is no longer present within the connecting region passageway 31. The illustrated embodiments are used as nasal pancreatic drainage stents, ureteral or urethral stents, or other stents with one or more bent or porcine tail ends and various drainage configurations Can also be adapted to The exemplary embodiment of FIG. 41 further includes an intermediate bend to better fit the pancreaticobiliary and duodenal anatomy where the stent is placed.

  Another embodiment of the nasal gallbladder and nasal pancreatic drainage duct is shown in FIG. 43, which includes a pair of distal heel flaps 180 and no pig tail buttock. Except for this, it is the same as the embodiment of FIGS. Also, the side access port is suitably located near the distal end 12 of the device (eg, about 2 cm as compared to about 6 cm in the pig tail embodiment). Normally, the nasal gallbladder drainage tube is 5 to 10 FR in diameter, while this nasal pancreatic drainage tube is 5 to 7 FR in diameter. The pig tail and non-pig tail drain embodiments extend around the side access port 15 to provide pushability and, if present, close to the side access port. Conveniently, a reinforcing stylet (shown in FIG. 43) is included that straightens the loop or bend provided. Such bends allow the device to follow the patient's anatomy, such as successfully crossing the duodenal contour. An example of the bent or curved portion 172 is shown in FIG.

  19 and 20 show an embodiment of the balloon 47 of the present invention adapted for short wire applications. FIG. 19 shows an expansion balloon 47 (QUANTUM made by Wilson-Cook Medical, Inc.) made of a non-compliant material (e.g., PET) so that the balloon member 102 can expand to a predetermined diameter and expand the constriction in the tube. (Trademark) with a modified bile duct balloon). FIG. 20 includes an extraction balloon, such as a modified version of the TRI-EX ™ triple lumen extraction balloon (Wilson-Cook Medical Ink), which clears foreign objects from the tube, such as stones, sludge, etc. It is equipped with a non-compliant material (latex, silicone, etc.) made in the manner described above. Both embodiments include a side access port 15 about 6 cm from the distal end 12 of the catheter 10 so that the connecting region 14 extends through the balloon member 102 and exits proximally thereof. It has become. The embodiment of FIG. 20 is further maintained within the passage 27 of the catheter member 10 and is particularly rigid around the side access port 15 (and optional proximal side access port, not shown). A removable reinforcing stylet 103 is provided that is provided and is less susceptible to twisting at that location. The stylet is preferably made of metal (e.g., stainless steel) or a relatively hard plastic or other material, and in most applications, an engagement function similar to the distal wire lock 90 of FIG. This is not provided because it interferes with the ability to extrapolate the wire guide forward.

  FIG. 21 shows a biopsy device 104 for collecting cells in the bile duct. The illustrated embodiment with a modified CytoMAX II ™ dual lumen bile duct brush (Wilson-Cook Medical Ink) is shown on the side about 6 cm from the distal end 12 of the tubular portion 77 of the device 10. Access port 15 and a brush element 105 disposed near and extending beyond the distal end, the connecting region 14 terminates proximally of the brush element 105 and the wire guide 11 The distal opening 19 is disposed near the distal end of the tubular member 77 around the base of the brush element 105. An alternative device for delivering the biopsy device 104 or other device within the treatment site is shown in FIG. The illustrated tubular member 77 does not communicate with the connecting region passage 31 but includes a standard connecting region 14 around its distal end, except for the tubular member passage 27, which connects directly to the wire guide 11. Another elongated medical device that is not terminated terminates near an angled external opening 122 that is adapted to be retracted for introduction to the treatment site. The illustrated biopsy device 104 is advanced to collect a tissue sample and then pulled back into the passage 27 and removed from the patient body with the introducer 77 or removed to advance the second medical device into the passage. It is possible to take another action. In addition to the radiopaque marker band 18 to indicate the position of the second end of the connecting region 14, the illustrated tubular member provides an additional marker 123 in the vicinity of the angled opening, which is the practitioner. Provides additional guidance. The illustrated biopsy device is just one example of a device that can be delivered in the manner shown in FIG.

  Another secondary access device comprising a brachytherapy or radioactive seed delivery catheter 106 is shown in FIG. 28, but this catheter is a passage for the wire guide 11 (and includes the connecting region 14). 27 and a second passageway 107 having a closed end for receiving a radioactive element 108, such as a catheter, stylet, or individual radioactive seed introduced therein. The brachytherapy device 106 is extrapolated to the wire guide 11 and introduced to the treatment site for a period of time sufficient to deliver an effective therapeutic dose of radiation to adjacent tissue such as a tumor in the bile duct. Placed in. Typically, the side access port 15 is preferably about 6 cm from the tip and is made of a polymeric material that is flexible and does not damage the surrounding tissue. The second passage is preferably provided at the center so that the radiation is dispersed in all directions. As a result, the first wire guide passage terminates near or offset from the distal side access port 15 at least a point proximate to the side access port 15 and the coupling region 14. Is either offset.

  44-57 show a series of non-biliary devices that are designed to be inserted through the patient's mouth rather than through the accessory channel of the duodenoscope as in the embodiment described above. 44-57 typically includes using an ultra-short wire guide 11 that is advanced to the treatment site by connecting to the outside of the endoscope. The wire guide is disconnected from the endoscope and secured in a suitable position that serves as a passage for introduction of other devices, such as elsewhere in the esophagus or gastrointestinal tract. Optionally, the wire guide 11 (FIG. 57) is provided with a hydrophilic or other lubricious coating or surface 173 to make it easier to extrapolate and advance the device after it has been placed. (Eg, SLIP-COAT® biopolymer, STS Biopolymers Inc., Henrietta, NY). The covering is limited to a portion of the wire guide 11 such as the intermediate portion 97, and the proximal portion 59 (e.g., the proximal side 10-15 cm) that extends out of the patient's body and is maneuvered and locked by manipulation. Advantageously, it has a standard non-hydrophilic surface (eg, PTFE) that facilitates securing the wire guide in place. The distal portion 60 of the wire guide (eg, 2 cm to 6 cm) is also left uncovered so that the practitioner has better control so that the wire guide can be extrapolated from the connecting area of the device being advanced. Helps avoid unintentional premature disconnects. 57 is used in the small intestine or colon to allow the device to be slid more easily while the wire is at both ends and distal to the occlusal block. It is particularly advantageous if it can be fixed by each of the side loops 144.

  44 and 45 show a dilator catheter 88 and wire guide 11 with a system for dilating a stricture in the esophagus. The dilator 88 includes a scale marking system 133 disposed near the proximal portion of the tubular member. The illustrated embodiment is approximately 75 cm long and the display is arranged to display 40 cm, 50 cm and 60 cm marks to help align the device with the wire guide 11 introduced into the body. The guidewire includes a similar series of indicia 134, such as the illustrated bands, that increase in number at 10 cm intervals to indicate the distance from the reference point. Alignment markings 133, 134 are used to deliver the wire guide to a treatment site, such as a GE (gastroesophageal) junction, stenosis, or other site subject to dilation, irradiation or other treatment It is useful that the device can be accurately positioned after the treatment site is confirmed using the endoscope.

  A method for introducing the wire guide 11 and dilator catheter 88 of FIGS. 44 and 45 into the esophagus and subsequently performing a series of esophageal dilatations using a larger dilator catheter is shown in FIGS. 55a to 55f. It shows. This basic method is used when introducing other devices that are too large to be introduced through the accessory channel of the endoscope, or where standard endoscope placement techniques are not appropriate or possible. Can be used. As shown in FIG. 55a, the wire guide 11 is transported to the treatment site using the endoscope 38 and the wire guide transport mechanism 174. The wire guide transport mechanism 174 is shown in FIG. 48 in the illustrated embodiment. An endoscope wire guide holder 140 is provided in the accessory channel 165 of the endoscope through the wire guide 11 and a distal loop 144 near its distal end 25. And a mechanism for coupling. As shown, the endoscope wire guide holder 140 is provided in a side recess 142 near its distal end 12 and in a passage 145 in the shaft 146 of the wire guide holder 140 and a distal loop 144 of the wire guide. And a longitudinally slidable pin member 141 adapted to traverse the catheter. The pin member 141 advances to secure the loop 144 in the recess 142, and transports the wire guide 11 at least substantially outside the accessory channel 165 of the endoscope down to the treatment site, where the wire The guide is released when the practitioner operates the fingering portion 148 of the handle 147 until the thumb 144 slides out of the pin member 141 with which the loop 144 retracts. When the pin 141 fully enters the locking channel 143 extending distally from the side recess 142, the loop 144 is secured and cannot slide out freely. The endoscope wire guide holder 140 is then withdrawn from the treatment site along with the endoscope, but may carry the wire guide 11 partially extended from the attached channel, or the distal end 25 of the wire guide may be It can be withdrawn in an attached channel 165 (shown) to be drawn in.

  A second embodiment of the wire guide transport mechanism 174 is shown in FIGS. 46 and 47, and the wire guide transport mechanism 174 is external to the endoscope 38 using a friction fit, clamp mechanism or some other known means. A ring element 136 is mounted near the distal end of the wire and is configured to releasably secure the wire guide 11 delivered to the treatment site. The wire guide 11 includes a removable element 135, such as the illustrated distal ball, which is crimped, glued or otherwise fastened around the end 25 of the wire guide, or It is designed to slip or break off when applied with a substantial amount of pulling force (eg 3 pounds) and safely pass through or be absorbed by the gastrointestinal system. The ball tip 135 is inserted into the open slot 137 of the ring 136 and slides laterally under the lip 138 to fit into the recess 139, which helps to secure the wire guide together. And pulling the wire guide together with the endoscope. With the ball 135 fitted in a recess 139 formed along the distal edge of the ring, the wire guide 11 pulls on the proximal portion of the wire guide and maintains a reverse force on the endoscope 38. By holding it in that position, it can be disconnected from the endoscope 38. When the ball 135 is released (FIG. 45a), the wire guide 11 slides under the lip 138 (FIG. 47) and the endoscope 38 is withdrawn from the patient leaving the wire guide in place.

  Returning to FIG. 55 a, the endoscope is usually placed immediately proximal to a specific site to be treated in the surgical site 41 (sphincter, stenosis, lesion, etc.). In the illustrated method, the endoscope 38 is advanced to the GE junction 156, while a depth marking provided near the proximal portion of the endoscope from a patient (not shown) is provided to the practitioner. Provides the distance from the treatment site. At this point, the distal end 25 of the wire guide 11 is also engaged near the distal end of the endoscope 38 and is therefore generally located at the GE junction 156. The endoscope 38 and wire guide are advanced through the esophagus 155 and placed at the GE junction 156, where the distance is indicated. The practitioner advances the endoscope 38 by 10 cm (or other similar predetermined distance) so that the distal end 25 fits well in the stomach 157 (about 10 cm past the GE junction 156). . Alternatively, as shown in FIG. 55b, the practitioner advances the wire guide retainer 140, which also includes a depth marker on the proximal side, past the endoscope 38 and into the stomach 157 by a similar distance. 45 and 50, the fiducial mark 175 is 10 cm from the distal end 25 (or any one that advances the wire guide past a GE junction or other anatomical reference point. Distance). The exemplary embodiment wire guide 11 shown in FIG. 45 includes a series of proximal representations 134 (eg, fiducial marks 175-30, 35) with a varying number of markings disposed longitudinally at selected intervals. , 40, 45, 50 and 55 cm). In another embodiment shown in FIG. 50, the wire guide has five 5 cm bands 150 of different colors between the 30 cm mark and the 55 cm mark as measured from the reference mark 175 10 cm from the tip 25. . The display 134 may further include a 1 cm reference mark 177 (for example, a hash mark) in each color band 150. The band 150 in the embodiment of FIG. 50 preferably has a color scheme that contrasts with adjacent bands. For example, it is convenient to arrange the cold and warm colors next to each other so that the arrangement is yellow, green, red, blue, and orange.

  When the wire guide 11 is advanced to the point where the GE joint portion 156 has passed 10 cm, the wire guide 11 is disconnected from the wire guide transport mechanism 174 and includes an integral wire guide fixing portion 154 and fixes the occlusal block 151 around the patient's head. It is secured in place by any means such as using the exemplary occlusal block 151 shown in FIG. 52 that includes a strap 153. In addition to functioning as a mechanism 50 for securing the wire guide in place, the bite block has an open working area 152 through which the endoscope, wire guide 11 and primary or secondary device can be operated. It is sent to the part.

  In cases where there is a narrow stenosis that cannot accommodate the endoscope without risk of laceration in the esophagus (at least without proper prior dilatation), the wire guide retainer 140 may include the stenosis. If the dilator is the smallest dilator, it can advantageously serve as a path for advancing the dilator that is smaller than the diameter of the endoscope.

  Next, as shown in FIG. 55c, the illustrated method allows the primary access device 10 with the first dilator 167 to be extrapolated into the wire guide 11 and advanced so that a medical procedure can be performed as shown in FIG. 55d. The endoscope 38 and the wire guide holding device 140 are usually pulled out from the treatment site 41. When the first dilator 167 is advanced, the wire guide 11 is temporarily unlocked from the holding device so that its proximal end can pass through the connection region 14 of the dilator. Alternatively, the primary device 10 (eg, dilator 167) may be coupled to the wire guide 11 before the wire guide is advanced to the treatment site 41. The illustrated dilator 167 includes optional radiopaque marker bands 18, provided on the side access port 15 and the distal edge of the widest portion in front of the tapered end of the device, respectively. 132 is included. The GE junction is set as the anatomical reference point where the wire guide 11 and the primary access device 10 shown in the figure are aligned, but the region of the esophagus having the stenosis to be expanded is located on the proximal side of the GE junction. It may be anywhere. The reference point for the GE junction desirably provides a certain known distance in the stomach for disconnection.

  The dilator 167 (FIG. 44) also includes a series of proximal markers 133 that align with the wire guide display 134 so that the practitioner can select a certain point along the length of the dilator (eg, the maximum width portion 132). It is desirable to be able to determine when the distal end, tip 12, side access port 15 etc.) of the GE junction, wire guide tip or some other reference point has been reached.

  As the first dilator 167 passes through the esophageal constriction or GE junction 156 as the first dilatation stage of its opening, the distal portion 13 completely enters the patient's stomach 157, so that FIG. Decoupling is performed as shown. Typically this will advance the side access port 15 past the distal end 25 of the wire guide 11 that remains fixed in place until the distal end 25 is free to slide out of the coupling region 14. Is realized. As with the bile duct technique shown in FIGS. 9a-9f and 29a-29e, the disconnected primary access device 10 is then removed from the patient and a second (larger) dilation as shown in FIG. 55f. A secondary access device (third elongate medical device 44), such as instrument 168, is introduced into the surgical site 41. Esophageal dilation usually involves passing through a series of dilators of increasing size, but if no resistance is sensed during the initial dilation, one or more smaller dilators May be omitted.

  An alternative embodiment of a dilator catheter 167 is shown in FIG. 56, in which the side access port 15 leads to a proximal portion 171 where the distal (large) diameter portion 170 of the dilator is smaller. It is provided on the surface or surface 169 facing the transitioning proximal side. This is advantageous because the wire guide 11 will not line up with the widest portion of the dilator 167 as both pass through the constriction. The stepped configuration shown is also useful in other embodiments of the present invention to eliminate friction caused by a wire guide passing through a sheath or channel, such as in an endoscope.

  The general method of FIGS. 55a-55f places other devices outside the endoscope, such as the photodynamic therapy (PDT) balloon 47 shown in FIG. 51, or the achalasia balloon 53 shown in FIG. It can also be adapted to Both devices shown are commercially available from Wilson-Cook Medical Inc., which shows a modification to ultra-short wire delivery. The placement of the PDT balloon 47 uses an endoscope to find the GE joint, and a GE joint by a distance that corresponds to the fiducial (or “zero”) mark 175 of the wire guide, for example, a known suitable distance such as 10 cm. This is done by placing the wire guide 11 past the part. In the exemplary embodiment of FIGS. 50-52, the wire guide includes a color band that corresponds to the color band that constitutes the proximal marker 133 of the PDT balloon catheter 47, and the colors are aligned (FIG. 52). In the case of a PDT balloon, the reference point 176 of the device 10, which is the distal edge of the light emitting portion 178 of the balloon member 102, is located at the GE junction. Thereby, the light emission part 178 can be arrange | positioned in the optimal position for disease treatment (for example, Barrett's esophagus). It should be noted that the color band 150 or other indicator 133, 134 of the illustrated embodiment is configured to align the treatment device 10 with the wire guide 11 and thereby the selected site for treatment. To provide other functions, such as a function to assist in aligning the tips 12 and 25 of the device with each other or the side access port 15 to indicate that the connection is about to be released. It does not have to be. Different markings may be used for alignment for connection and disconnection. The color band 150 of the wire guide 11 is configured to recall the reference mark 175 corresponding to the GE joint (in this embodiment), but the color band 150 of the primary access device 10 is the color band of the wire guide. The device is arranged in the correct position for treating the disease. As such, they are not necessarily the same reference scale (usually not the same).

  FIG. 53 shows an embodiment where the primary access device 10 comprises an achalasia balloon. The achalasia procedure is different in that the balloon is placed across the GE joint rather than at the proximal side of the GE joint and corresponds to a proximal reference marker (not shown). The reference point 176, which allows the device to align with the GE junction, is provided in the center of the balloon member 102, not at the distal edge as with a PDT balloon.

  The technique of pulling the wire guide out of the endoscope, sending it to the treatment site, releasing the connection, and extrapolating it to advance the device is a feeding tube that is orally advanced and placed in the stomach or small intestine (e.g. It can also be applied to multiple larger diameter catheters (FIG. 54), such as nasal jejunum tubes, nasal bowel tubes, and the like. These catheters pull the catheter device 10 together when the endoscope is withdrawn from the treatment site, and pull out the wire guide 11 that is normally fixed at a fixed position from the connection region 14. In order to prevent this, the passage 27 may advantageously include a reinforcing stylet 103. The stiffening stylet 103 is used before or after the device is uncoupled using a radiograph, an endoscope, and / or a marker device visible on the proximal side of the two devices 10,11. It is taken out.

  The gastrointestinal tract is currently the easiest-to-understand anatomical site for performing the methods and techniques of the present invention, but with future changes in interventional medicine, remote disconnection and ultrashort wire techniques have become more traditional. There will be more opportunities to replace rapid exchange or other current methods. For example, many common urological procedures have been performed using wire guide replacement until the introduction of an ideal video endoscope for use in the urology. With the introduction of video endoscopes, direct viewing has become the standard method for manipulating and positioning the device in the ureter. As external vision technology develops and improves in the future, remote disconnection may return to a wire-guided approach that offers real benefits to urologists. Similar advances in other specific areas, especially vascular and arterial medicine, will recognize the potential benefits of remote disconnection.

  Other undisclosed or attendant details in the arrangement and combination of various elements involved in the disclosed embodiments of the invention and their use are the characteristics necessary for those elements to function as disclosed. As long as they are provided, none of them is considered to be a critical matter for realizing the advantages of the present invention. The selection of these and other details of construction is considered to be well within the ability of those having basic skill in the art in light of the present disclosure. The illustrated embodiments of the present invention have been described in considerable detail for the purpose of disclosing the actual operational structure thereby enabling the invention to be effectively implemented. The designs and methods described herein are for illustrative purposes only. The novel features of the invention can be incorporated into other structural forms without departing from the spirit and scope of the invention. The invention includes embodiments that comprise and consist of the elements and steps described with respect to the illustrated embodiments. Unless otherwise indicated, all common words and terms used herein shall be construed in the conventional meaning defined in the New Shorter Oxford English Dictionary 1993 edition. All technical terms shall be construed in the conventional sense established by the appropriate technical order utilized by those having general skill in a particular technical field. All medical terms shall be construed as defined in the Steadman's Medical Dictionary 27th edition.

Figure 2 shows a perspective view of a prior art sphincterectomy for short wire replacement. FIG. 2 is a cross-sectional view taken along line 2-2 of FIG. Figure 2 shows the device of Figure 1 being used with an endoscope. FIG. 3 shows a side view of an example catheter made for use in the example system and method. FIG. 5 shows a cross-sectional view of the distal portion of the embodiment of FIG. 4 and an illustrative wire guide coupled thereto. FIG. 4 shows a side view of an embodiment of the present invention where the connection region comprises an external channel. FIG. 6 shows a side view of a wire guide with the proximal portion oriented at an angle relative to the distal and intermediate portions. FIG. 6 illustrates a side view of an embodiment of a proximal elongate marking system provided on a first elongate medical device and a wire guide. Fig. 4 shows the steps of an example of the method of the present invention in which multiple catheter devices are extrapolated and exchanged in a common bile duct with a guide wire. Fig. 4 shows the steps of an example of the method of the present invention in which multiple catheter devices are extrapolated and exchanged in a common bile duct with a guide wire. Fig. 4 shows the steps of an example of the method of the present invention in which multiple catheter devices are extrapolated and exchanged in a common bile duct with a guide wire. Fig. 4 shows the steps of an example of the method of the present invention in which multiple catheter devices are extrapolated and exchanged in a common bile duct with a guide wire. Fig. 4 shows the steps of an example of the method of the present invention in which multiple catheter devices are extrapolated and exchanged in a common bile duct with a guide wire. Fig. 4 shows the steps of an example of the method of the present invention in which multiple catheter devices are extrapolated and exchanged in a common bile duct with a guide wire. FIG. 3 shows a side view of an embodiment of the present invention wherein the first elongate medical device comprises a balloon catheter. FIG. 4 shows a view in place of the sphincterectomy knife of the present invention being used to introduce a second wire guide into the branch of the passage. FIG. 2 shows a perspective view of an illustrative wire guide retention system of the present system and method. FIG. 7 shows a side view of a wire guide having a coupling mechanism for attaching a second wire guide to the proximal end. FIG. 4 shows a side view of the collection basket of the present invention including a coupling ring that engages a wire guide. FIG. 6 shows a cross-sectional view of a sphincterectomy catheter with a breakable wire guide passage. FIG. 6 shows a cross-sectional view of a sphincterectomy catheter with a breakable wire guide passage. Figure 3 shows a side view of the gallbladder stent and delivery catheter of the present invention. FIG. 4 shows a side view of an embodiment of the present invention comprising an area that can be broken into a tubular member. Figure 3 shows a side view of the dilatation balloon of the present invention. Figure 3 shows a side view of the extraction balloon of the present invention. 1 shows a side view of a biopsy device of the present invention. FIG. 2 shows a side view of the self-expanding prosthesis delivery device of the present invention. FIG. 2 shows a partial cross-sectional side view of a first embodiment of an elongated engagement member (distal portion) comprising a wire stop member. FIG. 24 shows a side view of the proximal portion of the embodiment of FIG. FIG. 6 shows a partial cross-sectional side view of a second embodiment of an elongated engagement member comprising a thread-like member. Figure 3 shows a third marking system provided in the middle visible part of the connected device of the present invention. Figure 3 shows a third marking system provided in the middle visible part of the connected device of the present invention. 1 shows a cross-sectional view of a stent and pusher device of the present invention. 1 shows a cross-sectional view of a radioactive seed delivery device of the present invention. FIG. 18 illustrates a method for delivering a plurality of stents into the common bile duct using the system embodied in FIG. FIG. 18 illustrates a method for delivering a plurality of stents into the common bile duct using the system embodied in FIG. FIG. 18 illustrates a method for delivering a plurality of stents into the common bile duct using the system embodied in FIG. FIG. 18 illustrates a method for delivering a plurality of stents into the common bile duct using the system embodied in FIG. FIG. 18 illustrates a method for delivering a plurality of stents into the common bile duct using the system embodied in FIG. 1 shows a partial cross-sectional view of a wire guiding wire of the present invention. FIG. 4 shows a partial cross-sectional view of an embodiment of the present invention in which a connection region is provided on another member. FIG. 4 shows a partial cross-sectional view of an embodiment of the present invention in which a connection region is provided on another member. FIG. 4 shows a side view of an embodiment of the present invention having two distal access ports. FIG. 6 shows a perspective view of an embodiment of the present invention where the wire guide is hooked to the side access port. Figure 5 shows a side view of a hooked wire guide before and after uncoupling. Figure 5 shows a side view of a hooked wire guide before and after uncoupling. 1 is a side view of an embodiment of the present invention comprising a coaxial member provided with a pair of slots. FIG. FIG. 37 shows a cross-sectional view along the line 37-37 of the embodiment of FIG. Figure 2 shows a partial cross-sectional view of the introducer member of the present invention. Figure 2 shows a partial cross-sectional view of the delivery catheter of the present invention. FIG. 3 shows a side view of an embodiment of the present invention comprising a tactile alignment marker system. Fig. 4 shows a side view of the deployed shape of the pig tail drainage catheter of the present invention. FIG. 42 shows a partial cross-sectional view of the embodiment of FIG. 41 coupled to a wire guide. FIG. 10 shows a side view of an alternative embodiment of a drainage catheter having a heel flap. Figure 3 shows a side view of the dilator catheter of the present invention. FIG. 4 shows a side view of the wire guide of the present invention adapted for transport to a surgical site by an endoscope. FIG. 46 shows a side view of the device attached to the endoscope carrying the wire guide of FIG. 45. FIG. 47 shows an end view of the embodiment of FIG. 46. The side view of the wire guide conveyance mechanism of this invention is shown. FIG. 49 shows a cross-sectional view of the distal portion of the embodiment of FIG. 48 engaged with a tip loop wire guide. FIG. 50 shows a side view of the tip loop wire guide of FIG. 49. 1 shows a side view of a balloon for photodynamic therapy of the present invention. FIG. 52 shows a top view of the device of FIGS. 50 and 51 introduced through the occlusion prevention / wire guide holder of the present invention. The side view of the achalasia balloon of this balloon is shown. FIG. 4 shows a partial cross-sectional view of the nasal enteral tube of the present invention including a reinforcing stylet. Each stage of esophageal dilation using this method is shown. Each stage of esophageal dilation using this method is shown. Each stage of esophageal dilation using this method is shown. Each stage of esophageal dilation using this method is shown. Each stage of esophageal dilation using this method is shown. Each stage of esophageal dilation using this method is shown. FIG. 6A shows a side view of a dilator having a small diameter portion proximal to a side access port. Figure 3 shows a wire guide of the present invention including a smooth intermediate portion. FIG. 9 shows a partial cross-sectional side view of an embodiment of an elongated engagement member (distal portion) with an alternative wire stop member. FIG. 59 shows a cross-sectional view along lines 59-59 of each of the alternative embodiments to the wire stop member of FIG. FIG. 59 shows a cross-sectional view along lines 59-59 of each of the alternative embodiments to the wire stop member of FIG. FIG. 59 shows a cross-sectional view along lines 59-59 of each of the alternative embodiments to the wire stop member of FIG. FIG. 59 shows a side view of the proximal portion of the embodiment of FIG. 58. FIG. 9 shows a partial cross-sectional side view of an embodiment of an elongated engagement member (distal portion) comprising another alternative wire stop member. FIG. 9 shows a partial cross-sectional side view of an embodiment of an elongated engagement member (distal portion) comprising another alternative wire stop member. FIG. 9 shows a partial cross-sectional side view of an embodiment of an elongated engagement member (distal portion) comprising another alternative wire stop member.

Claims (35)

A tubular member having a coupling region configured to be coupled with a wire guide, the coupling region being disposed near a distal end of the tubular member and having a length substantially shorter than the length of the tubular member; An elongated engagement member for use with an elongated medical device comprising:
When the wire guide is coupled to the tubular member, a substantial portion of the wire guide is disposed outside the tubular member, and the elongate engagement member is the elongate medical device. An elongate engagement member configured to engage and releasably secure a wire guide coupled to the wire guide and prevent relative movement between the wire guide and the elongate medical device.   The elongate engagement member includes an elongate shaft, the elongate shaft having a distal end configured to frictionally engage an outer surface of the wire guide and an inner wall of a passage in the tubular member. The elongate engagement member of claim 1.   The elongate engagement member of claim 2, wherein the distal end of the shaft is configured to engage a portion of the wire guide disposed within a passage of the tubular member.   The elongate engagement member of claim 2, wherein the elongate shaft further comprises a proximal end configured to releasably engage a proximal port of the elongate medical device.   The elongate engagement member according to claim 2, wherein the elongate shaft comprises a plurality of shaft portions having different physical properties.   The elongate engagement member of claim 5, wherein the plurality of shaft portions are composed of a plurality of materials.   The elongate engagement member of claim 5, wherein the plurality of shaft portions comprises a plurality of cross-sectional areas.   The elongate engagement member according to claim 2, wherein the elongate shaft includes a tapered portion that decreases in cross section toward a distal end thereof.   The elongate engagement member of claim 2, wherein the elongate shaft has a non-circular cross section.   The elongate engagement member of claim 9, wherein the non-circular cross section of the elongate shaft is slidably extended through a passage having a corresponding shape of the tubular member.   The elongate engagement member according to claim 2, wherein the elongate shaft comprises a radiopaque marker disposed near a distal end thereof.   The elongate engagement member includes a tether, the tether being sufficient to at least partially surround the periphery of the wire guide to frictionally engage the wire guide with a portion of the tubular member. The elongate engagement member according to claim 1, having a distal loop made to allow application of a lateral force.   13. The elongate engagement member of claim 12, wherein the tether is configured to pass through a passage in the tubular member of the elongate medical device.   The elongate engagement member of claim 13, wherein the tether further comprises a proximal end portion configured to releasably engage a proximal port of the elongate medical device.   The elongate medical device includes a first lumen, a second lumen, and an inner wall disposed between the first lumen and the second lumen, and the elongate engagement member is disposed within the second lumen. An elongate shaft configured to be disposed with the elongate shaft having a distal end portion configured to engage the inner wall and displace it into the first lumen. The elongated engagement member of claim 1, wherein the inner wall engages with the outer surface of the wire guide when so displaced.   The second lumen has a portion that decreases in cross-section along a portion thereof, and the portion that decreases in cross-section is configured to engage with the distal end portion of the elongated shaft. The elongated engagement member of claim 15, wherein the engagement displaces the inner wall into the first lumen.   The elongate engagement member of claim 15, wherein the distal end portion of the elongate shaft comprises an expandable member for engaging and displacing the inner wall into the first lumen. In a system for introducing a plurality of medical devices to a treatment site in a body cavity of a patient,
An elongate medical device comprising a tubular shaft extending between a distal end and a proximal end, wherein a lumen extends through at least a portion of the tubular shaft, the lumen extending away from the shaft. Extending between a distal opening near the distal end and a proximal port near the proximal end of the shaft, the lumen extending between the distal opening and the proximal opening An elongate medical device comprising a connection region, wherein the proximal opening is disposed at a substantial distance from the proximal end of the shaft;
A wire guide comprising a shaft extending between a distal end and a proximal end, wherein the shaft is configured to slidably extend through the lumen of the elongated medical device. A guide,
An elongated engagement member,
The wire guide can be moved from a connected position to a disconnected position, the wire guide being in the connected position when the proximal opening, the connecting region and the distal opening of the elongate medical device Extending through the proximal opening, the connecting region and the distal opening of the elongated medical device when in the uncoupled position,
The elongate engagement member is configured to engageably and releasably secure the wire guide in the coupling position and prevent relative movement between the wire guide and the elongate medical device. .   The elongate engagement member includes an elongate shaft that is configured to frictionally engage an outer surface of the wire guide and an inner wall of the tubular shaft within the coupling region of the elongate medical device. The system of claim 18, having a distal end.   The system of claim 19, wherein the distal end of the shaft is configured to engage a portion of the wire guide disposed within a lumen of the connection region of the elongate medical device.   The elongate shaft further comprises a proximal end that is configured to releasably engage the proximal port of the elongate medical device, the proximal port comprising the proximal opening. 20. The system of claim 19, wherein the system is spaced from and disposed proximally.   The system of claim 19, wherein the elongate shaft comprises a plurality of shaft portions having different physical properties.   24. The system of claim 22, wherein the plurality of shaft portions comprises a plurality of materials.   The system of claim 22, wherein the plurality of shaft portions includes a plurality of cross-sectional areas.   The system of claim 19, wherein the elongate shaft includes a taper that decreases in cross section toward the distal end thereof.   The system of claim 19, wherein the elongate shaft has a non-circular cross section.   27. The system of claim 26, wherein the lumen of the elongate medical device comprises a non-circular cross section corresponding to the same portion of the elongate shaft.   The system of claim 19, wherein the elongate shaft comprises a radiopaque marker disposed near the distal end thereof.   The elongated engagement member includes a tether, the tether being at least partially surrounding the wire guide and frictionally engaging the wire guide with a portion of the tubular shaft of the elongate medical device. The system of claim 18, comprising a distal loop configured to allow sufficient lateral force to be applied.   30. The system of claim 29, wherein the tether is made to pass through the lumen of the tubular shaft of the elongate medical device.   The anchoring string further comprises a proximal end portion configured to releasably engage the proximal port of the elongate medical device, the proximal port comprising the proximal opening. 32. The system of claim 30, wherein the system is spaced proximally and disposed proximally. In a method for introducing a plurality of medical devices to a treatment site in a body cavity of a patient,
a) an elongate medical device comprising a tubular shaft having a distal portion and a proximal portion and a lumen extending there between, the elongate medical device comprising a connecting region; And the stage of
b) providing a wire guide comprising a wire guide shaft extending between a distal end and a proximal end;
c) providing an elongate engagement member having a distal end portion and a proximal end portion;
d) releasably connecting the wire guide to the elongate medical device by engaging the wire guide with the connection region of the elongate medical device;
e) engaging the wire guide with the elongate engagement member, releasably securing the wire guide in the coupled position, and preventing relative movement between the wire guide and the elongate medical device; ,
f) A method comprising the elongate medical device, the wire guide, and advancing the elongate engagement member to a treatment site.   The elongate engagement member comprises an elongate shaft, and the step of engaging the wire guide with the elongate engagement member includes a portion of the wire guide disposed within the coupling region of the elongate medical device. 33. The method of claim 32, comprising frictionally engaging the distal end portion of the shaft of the elongate engagement member.   The elongate engagement member comprises an elongate shaft, and the step of engaging the wire guide with the elongate engagement member extends the shaft of the elongate engagement member distally through the lumen of the elongate medical device. 35. The method of claim 32, comprising the step of advancing to.   The elongate engagement member includes a tether having a loop at the distal end portion, and the step of engaging the wire guide with the elongate engagement member includes the wire guide with a loop of the elongate engagement member. 35. The method of claim 32, comprising applying a lateral force sufficient to releasably engage to frictionally engage the wire guide with a portion of the tubular shaft.