JP2004527267A - Steerable sphincterotome and cannula insertion, papillostomy, and sphincterotomy - Google Patents

Abstract

The present invention relates to a method and apparatus for performing endoscopic cannulation, papillostomy, sphincterotomy, and similar procedures. In accordance with the present technique, endoscopic cannulation of the common bile duct and papillotomy, and similar procedures, advance the device into the endoscope / duodenum endoscope and the distal tip of the device. Is achieved by exiting the endoscope at the location of the Vater's papilla adjacent to the sphincter. Here, the endoscope mechanism is operated to orient the distal tip of the device to the desired position and to properly cannulate the bile duct. For example, due to mismatches in the sphincterotome, anatomical site, and endoscopic manipulation, it is difficult to accurately and consistently position the sphincterotome for proper cannulation. The steerable sphincterotome of the present invention allows the physician to control the position of the distal tip of the device independently of the endoscope and adjust for device and anatomical mismatches. According to the present invention, the handle on which the cutting wire is mounted is freely rotatable with respect to the catheter. A handle secured to the cutting wire but rotatable relative to the catheter shaft provides a mechanism for transmitting the force to rotate the wire and rotate the tip of the device. If the handle rotates at the proximal end independent of the proximal shaft, force can be applied directly to the distal tip without twisting the entire shaft. A rotation lock for maintaining the orientation of the tip and / or a rotation marking indicating the amount of rotation may be provided.

Description

[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention generally relates to a device that is useful in performing diagnosis or healing therapy in a dendritic bile duct system, and particularly, to facilitate diagnosis and removal of gallstones in bile ducts and other parts of the dendritic bile duct system. Associated with a device suitable for
[0002]
[Prior art]
Traditionally, the movement of gallstones into the patient's common bile duct has been treated by common surgical procedures. Surgeons used to cut the bile duct to remove gallstones and usually removed the gall bladder. In recent years, less invasive therapies have replaced surgical procedures such as those described above, reducing patient trauma and shortening long hospital stays and recovery times.
For example, U.S. Pat. Nos. 4,696,668 and 4,781,677, both of which are assigned to Wilcox, provide a dissolving agent for the bile duct. Disclosed are therapeutic therapies that include measures that essentially dissolve gallstones. More specifically, the catheter includes a plurality of lumens for inflating and deflating each of the two balloons, draining bile, irrigating and draining lytic agents. Upon inflation of the balloon, the bile duct is occluded at two spaced apart sites, providing a sealed space for receiving the lytic agent.
[0003]
When this space is sealed from the residual dendritic bile duct system, lytic agents can access the gall bladder and the gallstones inside the gall bladder through the gall bladder duct, except for bile from the base of the gallbladder. The lytic agent will be trapped in high concentrations near the gallstones in the bile ducts. After the gallstones have dissolved, the balloon is deflated and the catheter can be withdrawn. In this particular approach, the catheter is steered into the dendritic biliary system utilizing a standard duodenal endoscope through the digestive tract. While this and similar approaches have the potential to minimize trauma to the patient, such treatment requires prolonged placement of the duodenum endoscope within the patient and is less effective. Not obvious, leading to potential side effects on the lysing agent.
[0004]
In an alternative approach, the surgeon adjusts the orientation of the surgical extraction forceps at least through an incision in the bile duct and inserts it into the dendritic bile duct system. For example, in U.S. Pat. No. 3,108,593 to Glassman, a surgeon incises both the bile duct and the duodenum. The surgeon then adjusts the withdrawal forceps through the bile duct incision, the dendritic bile duct system, the sphincter of Oddi, and the duodenum, and out through the duodenal incision. The extraction forceps include a series of cages spaced apart from each other in the longitudinal direction to capture gallstones in the bile duct and to remove gallstones through any incision.
U.S. Pat. No. 4,627,837 to Gonzalo discloses a catheter device with a pair of inflatable balloons at the distal end. The catheter is directed through the incision in the bile duct toward the duodenum. After the balloon at the distal end has passed the sphincter of Oddi, both balloons expand to secure the catheter in place. This allows the catheter to be used to perform irrigation and irrigation through other lumens and remove gallstones from the incised bile ducts while capturing gallstones in the second balloon.
[0005]
According to another therapy for the treatment of stenosis, a surgeon may insert a catheter device through the bile duct or duodenum to dilate and widen the sphincter of Oddi. For example, U.S. Pat. No. 4,705,041 to Kim discloses a dilator that is oriented through an incision in the bile duct and Oddi sphincter. An expandable tip expands Oddi's sphincter. U.S. Pat. No. 5,035,696 to Rydell discloses an electrosurgical device that can be directed through the duodenum to the Oddi sphincter for the purpose of performing a sphincterotomy. The device includes a cutting wire that is heated to cut the sphincter. U.S. Pat. No. 5,024,617 to Karpiel discloses a similar device that can be steered by a duodenal endoscope. U.S. Pat. No. 5,152,772 to Sewell, Jr. discloses a device for sphincterotomy that is oriented through an incision in the bile duct and includes a knife for cutting the sphincter. Has been disclosed.
[0006]
The use of duodenal endoscopy and sphincterotomy devices, as exemplified in the Leidel and Karpiel patents, allows physicians to diagnose and treat dendritic bile duct symptoms while minimizing invasive interventions in patients Will be able to For example, therapies such as those described in these patents eliminate the surgery required to open the bile duct. As a result, these therapies can be performed as outpatient or day surgery procedures. Such treatment greatly reduces patient trauma and reduces hospital stay and recovery time. For example, if the physician determines that gallstones are present in the dendritic bile duct system, especially the common bile duct, the physician can insert a duodenal endoscope into the duodenum to view the Oddi sphincter. The first catheter is then advanced through the working channel of the duodenum endoscope, with or without a guidewire, steered through the Oddi sphincter, and into the dendritic bile duct system. The contrast agent injected through the catheter allows fluoroscopy or other imaging procedures to be performed to confirm the presence of gallstones in the dendritic bile duct system.
[0007]
The physician then replaces the first catheter with a second catheter and performs a sphincterectomy, such as the type disclosed in the above-mentioned Leidel and Carpiel patents. The gallstone is then drawn through the dilated sphincter of Oddi using a third catheter, as exemplified in the Grassmann patent, or some other equivalent retrieval catheter, instead of the second catheter. Thereafter, the collection catheter is operated to release gallstones into the duodenum. Subsequently, the catheter, guidewire, and duodenum endoscope can be removed to complete the procedure.
Since this procedure only makes an incision during a sphinctomtomy, the trauma to the patient is significantly less than other prior art procedures. However, this procedure, as currently practiced, requires three separate catheters and two catheter exchanges. The only reason that such a catheter exchange is necessary is that the first, second, and third catheters inject a contrast agent to perform a sphincterotomy and remove gallstones. There is only function. The time required each time a catheter exchange is performed can increase patient trauma, prolong the procedure time, and reduce efficiency. Furthermore, each and every such procedure requires the use of two or three separate catheter devices.
[0008]
[Problems to be solved by the invention]
Accordingly, it is an object of the present invention to provide an apparatus for performing diagnostic and curative treatment therapies without having to replace the catheter.
Yet another object of the present invention is to provide a device that allows gallstones to be removed from the dendritic bile duct system by a procedure that reduces the number of catheters required and the number of catheter changes.
Yet another object of the present invention is to provide one catheter device that can perform a sphincterotomy and remove gallstones in the common bile duct.
It is yet another object of the present invention to provide a catheter device that can perform a sphincterotomy and inject a contrast material into the dendritic bile duct system.
Still another object of the present invention is to provide a catheter device capable of performing a sphincterotomy by injecting a contrast agent into the dendritic bile duct system and discharging gallstones in the bile duct into the duodenum. .
[0009]
Currently available products that can be modified according to the present invention include Boston Scientific Ultratome Ultratome XI, Stonetome, Stonetome, Fluorotome, Tapertome, R.X. C. Channel Sphincterotome (RX "C" Channel Sphincterotome), R.X.U.・ There is a tape tome (RX Tapetorme). Other products that can be modified according to the present invention include Wilson Cook Canulatome, Wiltex Accuratome, Bird ProForma, and Bard ProFormer Clever. There is a cut (Olympus Cleaver Clevcut).
[0010]
[Means to solve the problem]
Accordingly, the present invention provides a method of passing a catheter through a properly positioned endoscope, wherein the catheter comprises at least two lumens, or a guidewire lumen and a contrast agent. Preferably, there are three lumens, a lumen and a cutting wire lumen, so that the handle of the device secured to the cutting wire can rotate independently of the catheter shaft. The handle assembly is rotated to change the position of the distal tip independent of the endoscope position so as to achieve the desired position of cannulation of the common bile duct. A rotation marking may be used to indicate the current amount of rotation, and a rotation lock may be used to maintain tip orientation.
The present invention also provides a sphincterotome method that allows the handle of the mechanical device to be rotated again after cannulation, as needed to achieve the desired incision position, while the incision is interrupted by a current applied to the cutting wire. Is carried out. A rotation lock and a rotation marking may be incorporated.
[0011]
In accordance with the present invention, there is provided a catheter which preferably has three lumens: a guidewire lumen, a contrast agent lumen, and a cutting wire lumen. The catheter is rotatably mounted on a handle fixed to the proximal end of the cutting wire. The proximal end of the catheter may terminate in a shaped luer port assembly having a guidewire entry point and a contrast fluid injection point. The guidewire lumen and the contrast agent lumen terminate at the distal end of the catheter. The handle and the catheter or molded luer port assembly may be designed to snap together to facilitate fast and inexpensive manufacturing. A rotation lock and a rotation marking may be incorporated in this embodiment.
The present invention is disclosed in U.S. Patent Nos. 5,547,469, 5,868,698, 5,683,362, and U.S. Patent Application Serial No. 09 / 154,834. Improved apparatus and methods, all of which have been filed under the name of Rowland et al., Which are owned by the proprietors of the present application, the disclosure of which is common to this application. And these subjects are considered to be part of the invention as set forth below. FIG. 1 and FIG. 2 of this application are the first of this application. Accordingly, the original drawings 1 through 9 of the Roland et al application have been renumbered in the present case as shown in FIG. 3 through FIG.
[0012]
In accordance with one aspect of the present invention, the device can be used in a therapeutic regimen that includes a dilation procedure and other procedures to be performed. The device has a catheter with proximal and distal ends and proximal and distal portions. The catheter has first, second, and third generally parallel lumens. The first lumen has a larger diameter than both the second lumen and the third lumen, each of the three lumens extending between a proximal portion and a distal portion of the catheter. ing. A device for performing the dilatation procedure extends through the second lumen and operates at the distal end of the catheter in response to manipulation by an operator at the proximal end of the catheter. The first lumen has a proximal port for providing access to the first lumen, and the third lumen has a proximal port for providing remote control of another procedure. And a distal port.
[0013]
According to another aspect of the present invention, there is provided an apparatus for removing an object from a dendritic bile duct system. The device includes a catheter that is steered through the working channel of the duodenum and the sphincter of Oddi and into the dendritic bile duct system. The catheter comprises a first lumen, a second lumen, and a third lumen, wherein the first lumen is larger than either the second lumen or the third lumen; These three lumens generally extend between the proximal and distal portions of the catheter along axes parallel to each other. The device for incising the Oddi sphincter comprises a cutting wire extending along a length extending through the second lumen and coextensive with a portion of the distal portion of the catheter. Extending outward from the catheter means through the distal port. The handle is attached to the catheter at the proximal portion and also to the proximal wire portion to control the position and orientation of the cutting wire. A rotation lock and a rotation marking may be incorporated, each to fix the orientation of the distal tip and to indicate the orientation of the distal tip. An inflatable balloon is mounted at a distal portion spaced from the cutting wire and passes through a third lumen to remove gallstones in the dendritic bile duct system through the dilated sphincter of Oddi. Inflated.
[0014]
In accordance with yet another aspect of the present invention, there is provided an apparatus for directionally positioning a contrast agent into a dendritic bile duct system and performing a sphincterotomy through a working channel of a duodenal endoscope. The device is steered through the working channel of the duodenal endoscope and the sphincter of Oddi and placed in the dendritic bile duct system. The catheter comprises a first lumen, a second lumen, and a third lumen, wherein the first lumen is larger than either the second lumen or the third lumen. The three lumens generally extend between the proximal and distal portions of the catheter along axes parallel to one another. The device for cutting the Oddi sphincter comprises a cutting wire extending along a length extending through the second lumen and coextensive with a portion of the distal portion of the catheter. Extending outwardly from the catheter means through the distal port. A handle is attached to the catheter as well as to the proximal wire section to control the position and orientation of the cutting wire. A rotation lock and rotation markings may be incorporated, each to fix the orientation of the distal tip and to indicate the orientation of the distal tip. The proximal port of the third lumen is connected to a source of contrast agent, which carries contrast agent into the dendritic bile duct system through a distal port at the distal end of the catheter.
[0015]
BEST MODE FOR CARRYING OUT THE INVENTION
Various objects, advantages and novel features of the present invention will become more fully apparent from the following detailed description when read in conjunction with the accompanying drawings, wherein like reference numerals designate like elements, and wherein: ing.
FIG. 3 depicts a catheter device 10 that can inject a contrast agent into the dendritic bile duct system, perform a sphincterotomy, and move gallstones into the duodenum. Apparatus 10 has a catheter 11 which includes a proximal portion 13 extending from a proximal end 12 to a distal end 14 for clarity and a short distance from distal end 14. Position 15 extends. In a typical application, the catheter has a working length of 200 cm and the distal section 15 has a length of 6 to 9 cm. Typically, the distal portion 15 is smaller in diameter than the proximal end, so that the distal portion 15 has increased flexibility. Reducing the diameter reduces the trauma caused by the tip and allows the tip to reach a smaller passage while allowing the larger proximal end to have the required circumferential strength and stiffness. In particular, in this case, the proximal portion 13 is coextensive with the working channel of the duodenum. For example, the proximal and distal portions correspond to 7 Fr catheter dimensions and 5.5 Fr catheter dimensions (ie, about 2.286 mm (0.09 inch) and about 1.778 mm (0.07 inch), respectively). It may be made to have the diameter to be.
[0016]
As illustrated in particular in FIG. 4, the catheter 11 has three lumens. First lumen 16 is larger in diameter than either second lumen 17 or third lumen 20. In certain embodiments, the lumen 16 has a diameter at the proximal portion 13 of about 1.040 mm (0.040 inch), which dimension at the distal portion 15 is about 0.037 inch (0.94 mm). ) To accept a standard 0.035 inch (0.835 mm) guidewire. Further, the lumen 16 is located at a position offset from the center of the catheter 11.
Lumens 17 and 20 are each smaller in diameter than lumen 16 and are radially offset from the centerline of the catheter and are offset from each other. It is in a biased position. In certain embodiments, lumen 17 and lumen 20 each have an inner diameter of about 0.711 mm (0.028 inches) at proximal section 13, which dimension is about Reduce to 0.508 mm (about 0.020 inch). As will be described later, this lumen 20 holds a cutting wire that allows a sphincterotome to be performed and a contrast agent to be injected at a reasonable ratio. The angular spacing between lumen 17 and lumen 20 is about 45 degrees, and the angular spacing between first lumen 16 and each of lumens 17 and 20 is about 157.5 degrees. If this configuration utilizes the dimensions described above, the proximal portion 13 will easily pass through the working channel of any duodenal endoscope.
[0017]
Referring again to FIGS. 3 and 4, lumens 16, 17 and 20 each have an inlet port at proximal portion 13 and an outlet port at distal portion 15. are doing. Generally, and as described in more detail below, the first lumen 16 has an exit port through the distal end 14, but the exit ports of the lumen 17 and the lumen 20 are Depending on the application, the distal portion 15 may be provided at different positions.
In FIG. 3, one of the inlet ports 21 of the proximal portion 13 located adjacent the proximal end 12 is an inlet port 21 which provides an access to the lumen 16 and an optional A luer lock fitting 22 is provided. A more proximal entry port 23 provides access to lumen 17 and has an optional Luer lock fitting 24. A more proximal entry port 25 of the lumen 20 is co-extensive with a portion of a handle 26 attached to the proximal end 12.
[0018]
Turning to the distal portion 15, the catheter 11 of this particular embodiment holds an inflatable balloon 30 proximal to the excursion of the cutting wire 31 outside the catheter 11. As illustrated in FIG. 5, the lumen 17 exits at a distal exit port 32 that penetrates the side of the catheter 11 and meets the interior of the inflatable balloon 30. The extension of the lumen 17 extending beyond the distal port 32 is sealed by known manufacturing methods. As a result, fluid forced through inlet port 23, such as by a syringe (not shown) attached to luer lock fitting 24, inflates balloon 30 to a closed orientation as illustrated in FIG. However, the expansion diameter at this time is up to 20 mm.
5 and 6, the first lumen 16 extends through the catheter 11 and terminates at the exit port 33 at the distal end 14. Thus, the lumen 16 is adapted to receive a guidewire through the entry port 21 which extends through the catheter 11 and out of the distal end 14 such that the catheter is It allows you to slide on top.
[0019]
Referring to FIG. 6, the distal end 34 of the cutting wire 31 is attached to a clamp 35 formed at the distal end of the lumen 20. Shaved and spaced apart ports 36A and 36B allow the working portion 37 of the cutting wire 31 to exit the catheter 11 through the shaved opening 36A and be parallel to the catheter outside the catheter 11. And returns to the lumen 20 through the port 36B and the reinforcing sleeve 38. The cutting wire 31 then extends through the lumen 20 to the handle 26 illustrated in FIG. 3, where the cutting wire appears as the proximal end 40.
[0020]
As illustrated in FIG. 3, handle 26 includes a central member 41 terminating in a thumb ring 42. The central member 41 extends through a body 43 provided with opposing finger supports 44 and slides relative to the body. The central member 41 is also attached to the catheter 11, and thus is an extension of the catheter 11. The member 43 also has an internal connector 45, which clamps the proximal end 40 of the cutting wire 31. Thus, when the body 43 is in the distal position, as illustrated in FIG. 3, the distal portion 15 of the catheter draws an essentially straight line as illustrated in FIG. The operating portion 37 of the cutting wire 31 is in a state of being immediately adjacent to the catheter 11. When the body portion 43 is retracted, the cutting wire 31 bends the distal end upward as illustrated in FIG. 3 to make it essentially perpendicular to the main axis of the catheter, as shown in a later section. Make it come to the position to make.
The connector block 45 and the cutting wire 31 are generally conductive members attached to the RF heating source 47 by the RF connector 46. The process of applying energy to the cutting wire 31 and cutting the sphincter using such an RF heating source 47 is well known in the art and describes one possible sphincterotomy procedure that may be compatible with the device of the present invention. , But will not be described further here.
[0021]
Describing the structure of the device in this way allows one to understand the application of the device in a particular application. FIG. 7 is a partial cutaway schematic view illustrating the process of placing a duodenal endoscope 50 in the duodenum 51 adjacent to the sphincter of Oddi 52. The catheter 11 configured as shown in FIG. 3 passes through the sphincter of Oddi 52, enters the common bile duct 53, and avoids the pancreatic duct 54. The distal end 14 does not extend to the gall bladder 55.
The use of a series of radiopaque markers 56 on the distal portion 15 allows for proper positioning by fluoroscopy, but the distal end is provided with the clamp 35 and stiffening sleeve 38 of FIG. May be. Positioning of the catheter 11 can be performed with or without the guidewire 57 within the lumen 16 illustrated in FIGS. 4, 5 and 6. The guide wire 57 is withdrawn to inject the contrast agent so that the contrast agent can be injected through the lumen 16 for fluoroscopy, confirming that one or more gallstones 58 are present. do it. It is also possible to inflate the balloon 30 during the operation to close the bile duct 53 and prevent the contrast agent from moving to the duodenum 51 or pancreatic duct 54.
[0022]
FIG. 8 is an enlarged view illustrating the duodenum 51, the sphincter of Oddi 52, each part of the pancreatic duct 54, and the common bile duct 53. In FIG. 8, the positioning of the catheter 11 with respect to the duodenal endoscope 50 has been completed through the opening of the Oddi sphincter 52. The handle 43 of FIG. 3 has been withdrawn proximally, and the distal portion 15 has been deflected to an essentially right angle, causing the cutting wire 31 to abut a portion of the Oddi sphincter 52. Here, by applying the RF heating to the incision wire 31, the Oddi sphincter 52 is incised, and the opening passing therethrough is widened. Obviously, sphincterotomy is performed by direct visualization of the Oddi sphincter with a duodenal endoscope.
In addition, it has been confirmed by other persons skilled in the art that a catheter having a guidewire lumen and a cutting wire lumen may have a specific effect when the distal portion 15 exits the duodenum endoscope. It tends to exhibit angular orientation. This orientation is essentially independent of the angular position of the catheter when it is inserted into a duodenal endoscope. Due to the biased nature of the lumen 20 as illustrated in FIG. 4, as the distal portion 15 passes through the Oddi sphincter 52, the position of the cutting wire 31 is improved. In particular, the offset of the angle allows the cutting wire 31 to be better aligned with the common bile duct 53, and causes the cutting wire to retreat from the pancreatic duct 54.
[0023]
FIG. 9 depicts the catheter after a sphincterotomy and after being advanced over a guidewire 57 as if the catheter 11 had been used. FIG. 9 illustrates the catheter 11 after the balloon has been moved to a point beyond the gallstone 58 in the bile duct 53. When the catheter 11 is withdrawn as a result of inflation of the balloon 30, the balloon 30 moves the gallstone 58 and sweeps the gallstone to the duodenum 51 through the sphincter of Oddi 52.
As will become apparent from the description of the particular catheter device 10 illustrated in FIG. 3 and from the applications discussed in connection with FIGS. One catheter device can inject a diagnostic contrast agent, perform a sphincterotomy, and move gallstones in the common bile duct or other parts of the dendritic bile duct without changing catheters. Further, performing the functions described above using a catheter device that is easily adapted for use in a standard duodenal endoscope working channel by lumen positioning and sizing. Will be able to As a result, the gallstone can be removed from the dendritic bile duct system because the duodenal endoscope can be introduced through the digestive tract without performing a bile duct incision and associated surgical procedures. As a result, this entire procedure is performed faster and with fewer device parts than prior art procedures. The net effect is to reduce trauma to the patient and reduce the overall time and expense required to perform the treatment procedure.
[0024]
In FIG. 3, balloon 30 is placed proximal to cutting wire 31. FIG. 10 illustrates an alternative embodiment where the balloon 60 is located distally of the cutting wire 31. More specifically, the distal end of lumen 17A, which corresponds to lumen 17 of FIGS. 5 and 6, is sealed. A side exit port 61, which is skived or otherwise formed in the catheter 11, opens into a chamber 62 formed by a balloon 60. The first sealing portion 63 and the second sealing portion 64 of the balloon 60 are joined to the opening 61 at a position proximal to and distal from the opening 61, respectively, to seal the chamber 62.
When balloon inflation fluid is introduced through lumen 17A, balloon 60 is inflated to a closed orientation that corresponds to the orientation of the balloon illustrated in FIG. When the catheter 11 is retracted with the distal balloon 60 inflated, gallstones can be extracted from the bile duct. This particular embodiment, when determined that the gallstones are elevated in the dendritic bile duct system, and that minimal penetration of the distal portion 15 beyond the gallstones through the dendritic bile duct system is achieved, Alternatively, it is particularly suitable for applications where the physician considers it desirable to minimize the length of the distal portion 15 extending beyond the embolic balloon.
[0025]
FIG. 11 shows an alternative procedure, such as dilating the sphincter of Oddi or injecting a contrast agent into the dendritic bile duct system, as used in the diagnosis and treatment of stenosis in the dendritic bile duct system. Discloses another embodiment of the present invention. In this particular embodiment, the exit port 65 from the lumen 17B is located at the distal end 14 of the distal portion 15. Here, lumen 16 is used for a guidewire, and lumen 17B can be used to inject a contrast agent directly into the dendritic bile duct system while the guidewire is in place. Then, once the device is in place and the procedure is assured, there is no need to replace the catheter to perform a sphincterotomy.
As yet another alternative, a physician can determine the need for gallstone removal using a conventional catheter to inject a contrast agent. If the need for treatment has already been indicated, the physician may utilize a device such as that illustrated in FIG. 3 to catheterize only once over a guidewire passing through lumen 16 as previously described. Can be exchanged.
Thus, it will be apparent that an apparatus constructed in accordance with the present invention achieves several objects and several advantages of the present invention. In particular, a catheter device constructed in accordance with the present invention provides for injecting a contrast agent, performing a sphincterotomy without replacing the catheter at all, and for moving gallstones from the common bile duct to the duodenum through the expanded Oddi sphincter. Can be. In addition, the device allows the procedure described above to be performed by a duodenal endoscope, thereby minimizing patient trauma. Using only one catheter without changing catheters further reduces the time and expense associated with using multiple one-function catheter devices.
[0026]
As will be apparent from the foregoing description, many modifications can be made to the specifically disclosed embodiments. Different balloon structures may be utilized and located at alternative locations. Different cutting wire embodiments and different orientations may be utilized. Thus, while the invention has been disclosed with respect to certain embodiments, it will also be apparent that numerous modifications can be made to the disclosed apparatus without departing from the invention. In particular, it is contemplated that all of the above embodiments may be utilized in connection with a handle that is fixed to the cutting wire but is rotatable with respect to the catheter. The present invention may include a cutting wire and / or a rotation lock that locks the orientation of the rotation marking indicating the amount of rotation. It is, therefore, intended that the appended claims cover all such changes and modifications as fall within the true spirit and scope of the invention.
[0027]
Consistent with this, the following subject matter recited in the claims and applications of Roland et al. Is specifically recited in the claims in connection with the subject matter specific to the present invention, wherein Roland's subject matter includes: A handle fixed to the cutting wire but rotatable with respect to the catheter shaft.When the handle is rotated independently of the catheter, and the handle is rotated independently of the endoscope. In that the distal tip of the device rotates independently of the endoscope, allowing surgical personnel to better control the position of the device for cannulation and subsequent sphincterotomy. is there. The present invention may include a cutting wire and / or a rotation lock that locks the orientation of the rotation marking indicating the amount of rotation.
[0028]
Due to inconsistencies in sphincterotomy, anatomical procedures and endoscopic manipulation, it is difficult to accurately and consistently position the sphincterotome for proper cannulation. The steerable sphincterotome of the present invention allows the physician to control the position of the distal tip of the device independently of the endoscope and adjust for discrepancies between the device and the anatomy. According to the present invention, the handle on which the cutting wire is mounted is freely rotatable with respect to the catheter. Rotation of the handle of the present invention induces a twist in the installed cutting wire, which allows the distal end to be oriented without rotating the proximal end of the attached catheter. See FIG. 1 and FIG. The handle 66, which is secured to the cutting wire at location 80 but can rotate relative to the catheter shaft at location 81, provides a mechanism for transmitting the force to rotate the device tip while rotating the wire. ing. As the handle rotates independently of the proximal shaft, force can be applied directly to the distal tip without twisting the entire shaft. Also, a rotation lock to maintain the orientation of the tip and / or a rotation marking to indicate the amount of rotation may be provided. A one-piece molded luer port assembly for two and three lumen catheters is provided for snap-fitting to a rotatable handle, and is quick and economical as illustrated in FIGS. 1 and 1a. May be promoted. Alternatively, a prior art in-line lumen port could be configured to snap-fit to a rotatable handle, as illustrated in FIG.
[0029]
Referring to FIG. 12, the present invention also has a property known as a rotation lock. The rotation lock 68 allows the user to maintain the tip orientation at all times. This is accomplished by maintaining the position of the handle 66 relative to the branch connector after the handle has been rotated. The rotation lock 68 allows the user to release the handle 66 at any time during the procedure, while maintaining the orientation of the handle 66 while the lock remains engaged, Rotation can be prevented. Maintaining the position of handle 66 maintains the orientation of the distal tip at the desired orientation. Maintaining the orientation of the distal tip reduces the amount of time and effort required for cannulation even when the distal tip is moved. Preventing the distal tip from moving unexpectedly can also prevent the patient from being injured.
[0030]
Referring to FIG. 13, two pairs of mating detents 69 and slots 70 can be utilized to provide this rotation lock. The detent 69 and the slot 70 are arranged at the intersection of the main body 71 and the branch connector 67 along the central axis of the main body 71. In FIG. 13, the two pairs of detents 69 and slots 70 are 180 degrees apart from each other with respect to the central axis. Thereby, a lock position is provided every half rotation of the handle 66. During use of the device, detent 69 is disengaged from slot 70 as handle 66 is rotated. The detent 69 shrinks slightly when separated. When the handle 66 reaches a position 180 degrees from the position where the rotation started, the detent 69 recovers from the contracted state and engages with the slot 70 again. As the detent 69 traverses from one position to the next, there is a substantial amount of friction between the mated parts. This friction is strong enough that the handle can be released at all times without fear of losing the orientation of the distal tip.
[0031]
While the catheter is removed from the packaging, inserted into the endoscope, and operated by the endoscope, the rotation lock 68 also performs the secondary function of keeping the distal tip locked in the home position. Without this property, the initial orientation of the distal tip would be unpredictable. FIG. 13 a is a detailed view of the interaction between the detent 69 and the slot 70.
Referring to FIG. 14, when the detent 69 and the slot 70 are in the engaged state, the branch connector 67 and the finger ring 44 are all on the same plane. This acts as a rotation marker. Whenever the finger receiver 44 rotates flush with the branch connector 67, the rotation lock is engaged, thus signaling a 180 degree rotation from the previous position. Through the use of such markers, the user can more easily keep track of how much the handle 66 has been turned. This is useful if the user wants to return the distal tip to its original position. In fact, the user will know, for example, that the handle 66 has completed a three-step rotation from its original position. Therefore, in order to return the handle 66 to the original position, the handle must be rotated by three in the opposite direction.
[0032]
15a to 15d show an alternative embodiment of the rotation lock 68. FIG. 15a illustrates a genuine friction lock. The connection of the branch connector 69 to the handle 66 can be designed such that the rotary lock 68 is purely a functional part of the frictional interference between the two parts. Alternative embodiments may include various types of assembly joints to provide this friction. In the main embodiment, the two component assembly is achieved by mating the male posts of the branch connector with female holes of the same size and shape. An alternative embodiment can reverse this so that the male projecting member becomes part of the main body of the handle 66. A friction lock may be provided on each mating surface of the main body and the branch connector, in which case it will be orthogonal to the main axis. FIG. 16a illustrates a cross-section of the rotation lock along line ZZ of FIG. 15a.
[0033]
FIG. 15b shows an embodiment of the oval post lock of the present invention. The connection portion of the branch connector 67 to the handle 66 can also be designed by incorporating the male post 73 and the female hole 72 formed into an oval shape. In this embodiment, when the handle 66 is rotated with respect to the branch connector 67, the elliptical shaped hole 72 is deformed and the elliptical post 73 is allowed to rotate. When the handle 66 reaches the 180 degree rotated position, the oval shaped hole 72 attempts to return to its original shape, thus locking the handle 66 in place. As illustrated in FIGS. 15c and 15d, this basic concept may be extended to incorporate a shape different from the ellipse as illustrated in FIG. 15b. Those skilled in the art will appreciate that the shape of the outer surface governs the angle of rotation between each locked position. For example, when the shape of the post 73 and the hole 72 formed into an elliptical shape are formed by equilateral triangles (FIG. 15c), a rotation angle of 120 degrees exists between the lock positions. If a square shape is used (FIG. 15d), a 90 degree angle is provided between the locked positions. FIG. 16b illustrates a cross-sectional area along line YY of FIG. 15b. FIG. 16c illustrates a cross-sectional area along line XX of FIG. 15c, and FIG. 16d illustrates a cross-sectional area along line WW intercept of FIG. 15d.
[0034]
Figures 17a to 17c illustrate an alternative embodiment of the present invention, wherein a rotating marker is provided and may be included in the present invention. One skilled in the art will appreciate that these embodiments can be extended. Several styles of visual markers may be incorporated into this design to help the user know how much the handle 66 has been rotated from its original and / or previous position. . An alternative embodiment includes a set of radially located lines around the main axis at the area where the main body and the branch connector 67 meet (FIG. 17a). One line on the stationary component, ie on the branch connector 67, is mated with the corresponding line on the body 43. As the handle 66 is rotated relative to the branch connector 67, a series of lines on the body rotate past the stationary line on the branch connector 67. The lines each indicate the incremental amount of movement. For example, if there are four equally spaced lines in the body, each line passing through the marker on the branch connector means a 90 degree rotation.
[0035]
This property can be further improved by a number of methods. A continuous number can be used instead of a line to indicate the amount of rotation (FIG. 17b). The amount of rotation can also be indicated using colors that appear alternately. Alternating line patterns can be used as well (FIG. 17c).
Yet another alternative embodiment may utilize audible sound to inform the user of the amount of rotation. As a method of implementing this, the rotation lock characteristic can be designed such that one step can be clearly heard at predetermined points along the rotation trajectory of the main body.
[0036]
Referring to FIGS. 18a and 18b, some alternative means are shown, which may provide a branch connector. One skilled in the art will appreciate that such embodiments can be extended from the embodiments provided herein.
Although the invention consists of a connector with two lumens, the connector design can be easily modified to accommodate more than two lumens (FIG. 18a). This will allow future designs to incorporate both guidewire post connector 74 and injection port connector 75 as one component.
Yet another alternative to a branch connector of this design is one containing an electrical connector 76 (FIG. 18b). The electrical connector 76 is here integrated into the finger receptacle, but can be transferred to a branch connector.
[0037]
Referring now to FIGS. 19a and 19b, another embodiment of the present invention is similar to that described above, but may include a handle 66 with the addition of an arcuate lock. The bow lock assists the user in that the handle 66 can be released at all times and the catheter tip maintains the bowed position. Just as a rotating lock provides a safer and more efficient procedure, an arcuate lock provides a similar effect.
The bow lock can be incorporated into the design in a number of ways. In the simplest manner, the bow lock consists of a friction lock 77 provided between the finger rest 44 and the main body 43 (FIG. 19a). An alternative to this design would provide a similar friction lock, but would utilize the surface between the wire termination 78 and the main body 43 (FIG. 19b). The friction lock illustrated in FIG. 19b has been enhanced by incorporating several locking ribs 79. The locking rib 79 is used to hold the catheter tip at a special predetermined angle. In practice, locking the handle 66 in the first position would, for example, deflect the tip by 30 degrees. The next position deflects the tip by 60 degrees. This property allows the user more control in positioning the catheter tip inside the anatomical site. In either case, the finger rest 44 is actuated along the main body 43 and the catheter tip 80 bends in an arcuate manner, maintaining the position of the handle due to the friction between the mating components, and thus the arcuate shape. The position of the part will be maintained.
[Brief description of the drawings]
FIG. 1 is a plan view of one embodiment of a device constructed in accordance with the present invention with a rotatable handle attached to a cutting wire, and FIG. 1a shows a snap member of a handle connection of the device of FIG. It is a top view.
FIG. 2 is an alternate embodiment of the rotatable handle of the present invention.
FIG. 3 is a plan view of one embodiment of an apparatus constructed in accordance with the present invention.
FIG. 4 is a sectional view taken along line 2-2 of FIG. 3;
FIG. 5 is a cross-sectional view taken along line 3-3 of FIG.
FIG. 6 is a cross-sectional view taken along line 4-4 of FIG.
FIG. 7 depicts the device of FIG. 3 for injecting a contrast agent into the dendritic bile duct system, positioned through a duodenal endoscope.
FIG. 8 is an enlarged view depicting the orientation of the device of FIG. 3 for performing a sphincterotomy.
FIG. 9 depicts the device of FIG. 3 for moving material in the common bile duct positioned through a duodenal endoscope.
FIG. 10 is a cross-sectional view of an alternative embodiment of the device, as viewed generally along line 3-3 of FIG.
FIG. 11 is a cross-sectional view of another embodiment of the present invention, taken along line 3-3 of FIG.
FIG. 12 is an illustration of a rotatable handle of the present invention with a rotation lock.
FIG. 13 is a detailed view of the rotation lock of FIG.
13a is a cross-sectional view along the line AA in FIG.
FIG. 14 is a view showing an alignment state between the rotatable handle and the branch connector, and illustrating a state where the rotation of the rotatable handle is zero.
FIG. 15a shows an alternative embodiment of the rotation lock of the present invention.
FIG. 15b shows an alternative embodiment of the rotation lock of the present invention.
FIG. 15c illustrates an alternative embodiment of the rotation lock of the present invention.
FIG. 15d illustrates an alternative embodiment of the rotation lock of the present invention.
FIG. 16a illustrates a cross-sectional area of the alternative embodiment of FIG. 15a.
FIG. 16b illustrates a cross-sectional area of the alternative embodiment of FIG. 15b.
FIG. 16c illustrates a cross-sectional area of the alternative embodiment of FIG. 15c.
FIG. 16d illustrates a cross-sectional area of the alternative embodiment of FIG. 15d.
FIG. 17a illustrates three alternative embodiments of the rotational marking of the present invention.
FIG. 17b illustrates three alternative embodiments of the rotational marking of the present invention.
FIG. 17c illustrates three alternative embodiments of the rotational marking of the present invention.
FIG. 18a illustrates an alternative example of a branch connector.
FIG. 18b illustrates an alternative example of a branch connector.
FIG. 19a illustrates an arcuate lock included in the present invention.
FIG. 19b illustrates an arcuate lock included in the present invention.

Claims (21)

A device for use in therapeutic therapy, including dilation procedures performed within a patient, comprising a catheter adapted to be steered through a passageway in the patient, the catheter comprising a proximal end and a distal end. A proximal end and a distal end adjacent the proximal end and the distal end, respectively, wherein the device is substantially parallel to the first lumen and at least the second lumen. Further extending between the proximal portion and the distal portion, the device extending through the second lumen and responsive to manipulation at the proximal end position. A cutting wire for performing the dilatation procedure, the cutting wire having a distal end attached to the catheter at a distal end of the second lumen. Some of the cutting wires are located outside the catheter and Extends along the length of the portion coextensive parts, the device further comprises a handle for actuating the cutting wire from a point proximal of the catheter,
Attachment of the handle to the catheter allows rotation of the handle relative to the proximal end of the catheter, while engaging and rotating the proximal end of the cutting wire to rotate the handle. The device further comprising a rotatable coupling member that results in rotation of the distal portion of the catheter. The device of claim 1, further comprising a rotation lock that inhibits further rotation of the handle relative to a proximal end of the catheter. The device of claim 1, further comprising a rotation indicator configured to indicate an amount of rotation of the handle relative to a proximal end of the catheter. The apparatus of claim 3, wherein the rotation indicator is a visual indicator of the amount of rotation. 5. The apparatus according to claim 4, wherein the visual indicator has an indicator marking and a corresponding scale marking to provide an indication of the amount of rotation. 4. The device of claim 3, wherein the rotation indicator comprises a device that provides an audible indication in response to rotation of the handle relative to a proximal end of the catheter. A method of dissecting tissue in a body passage, the catheter having a first lumen configured to receive a wire guide and a second lumen configured to receive an electrosurgical cutting wire. Selecting, positioning the catheter at the desired location in the bodily passage using an endoscope, and activating the electrosurgical cutting wire in the second lumen.
Setting the orientation of the electrosurgical cutting wire by rotating a handle relative to a proximal end of the catheter. The cutting wire is attached to the handle, and the step of rotating the handle causes rotation of the proximal end of the cutting wire, such that the cutting wire is rotated within the second lumen. The method according to claim 7, characterized in that: The method of claim 8, wherein the distal end of the cutting wire is rotated by torsion of a portion of the cutting wire intermediate the proximal and distal portions of the cutting wire. The method of claim 7, further comprising the step of engaging a rotation lock to inhibit further rotation of the handle relative to a proximal end of the catheter. The method of claim 7, further comprising indicating an amount of rotation of the handle relative to a proximal end of the catheter by using a rotation indicator. The method of claim 11, wherein the step of indicating the amount of rotation includes a visual indication of the amount of rotation. 13. The method of claim 12, wherein the visual indication comprises an index marking and a corresponding graduation marking to provide an indication of the amount of rotation. 12. The method of claim 11, wherein the step of indicating the amount of rotation includes an audible indicator provided by a device in response to rotation of the handle relative to the proximal end of the catheter. A catheter handle,
A rotatable coupling member configured to allow free rotation of the proximal end of the catheter;
A clamping member configured to engage a proximal end of a device extending through a lumen formed in the catheter, wherein rotation of the handle causes rotation of the proximal end of the device within the lumen. And a catheter handle. The device of claim 15, wherein the device comprises a cutting wire extending from a proximal end of the catheter to a distal end of the catheter and connected to a distal end of the catheter. 16. The catheter handle of claim 15, further comprising a rotation lock engageable to prevent rotation of the handle with respect to a proximal end of the catheter. The catheter handle according to claim 15, further comprising a rotation indicator configured to indicate an amount of rotation of the handle with respect to a proximal end of the catheter. 19. The catheter handle of claim 18, wherein the rotation indicator comprises a visual indicator of the amount of rotation. 20. The catheter handle of claim 19, wherein the visual indicator comprises an index marking and a corresponding graduation marking to provide an indication of the amount of rotation. 16. The catheter handle of claim 15, wherein the rotation indicator comprises a device for providing an audible indication in response to rotation of the handle relative to a proximal end of the catheter.

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